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12-3671-ag

In the U.S. Court of Appeals for the Second Circuit


__________________

Natural Resources Defense Council, Inc.,

Petitioner,

v.

United States Environmental Protection Agency,

Respondent.
__________________

On Petition for Review of an Order of the
United States Environmental Protection Agency
__________________

PETITIONERS BRIEF AND SPECIAL APPENDIX


Of Counsel: Nicholas Morales
Natural Resources Defense Council
1152 15th Street, NW, Suite 300
Washington, DC 20005
(202) 289-1060

Selena Kyle
Natural Resources Defense Council
111 Sutter Street, Floor 20
San Francisco, CA 94104
(415) 875-6100

Counsel for Petitioner NRDC

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CORPORATE DISCLOSURE STATEMENT
Pursuant to Fed. R. App. P. 26.1, petitioner Natural Resources Defense
Council states that it has no parent companies, subsidiaries, or affiliates that have
issued shares to the public in the United States or abroad.



ii

TABLE OF CONTENTS
CORPORATE DISCLOSURE STATEMENT .......................................................... i
TABLE OF CONTENTS .......................................................................................... ii
TABLE OF AUTHORITIES ..................................................................................... v
LIST OF ACRONYMS AND ABBREVIATIONS ................................................. xi
JURISDICTIONAL STATEMENT .......................................................................... 1
STATEMENT OF ISSUES ....................................................................................... 1
STATEMENT OF THE CASE .................................................................................. 2
STATEMENT OF FACTS ........................................................................................ 6
I. The Food Act Requires EPA to Assess Pesticides Risks
to Human Health and to Prevent the Sale of Unsafe
Pesticides ......................................................................................................... 6
II. The National Academy of Sciences Has Proposed
Principles to Restrict EPAs Use of Studies Intentionally
Exposing Humans to Pesticides ....................................................................... 9
III. Congress Passed Section 201 to Restrict EPAs Use of
Studies Intentionally Exposing Humans to Pesticides .................................. 12
IV. EPAs Human Testing Rule Permits EPA to Use
Ethically Deficient Human Dosing Studies, Contrary to
Section 201 and the National Academys
Recommendations .......................................................................................... 16
V. EPA Used a Study Testing Dichlorvos on Humans to
Assess the Pesticides Safety, in Reliance on Its Unlawful
Human Testing Rule ...................................................................................... 18

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A. EPAs Office of Pesticides Reviewed and Identified
Ethical Deficiencies in the Dichlorvos Human Study ...............................21
B. EPAs Human Studies Review Board Identified
Ethical and Statistical Deficiencies in the Dichlorvos
Human Study .............................................................................................23
C. EPA Relied on the Dichlorvos Human Study to
Authorize Continued Use of Dichlorvos ...................................................25
VI. NRDC Brought Administrative and Legal Challenges to
EPAs Use of the Dichlorvos Human Study and
Continued Approval of Dichlorvos ............................................................... 27
STANDING ............................................................................................................. 29
SUMMARY OF ARGUMENT ............................................................................... 33
ARGUMENT ........................................................................................................... 35
I. Standard of Review........................................................................................ 35
II. EPAs Use of the Dichlorvos Human Study Violated
Section 201 .................................................................................................... 37
A. EPAs Application of Its Significantly Deficient Test
to Allow It to Use the Dichlorvos Human Study
Violated Section 201 ..................................................................................38
B. Section 201 Requires EPAs Rule on Use of
Intentional Human Dosing Studies to Be Consistent
with the National Academy of Sciences
Recommendations ......................................................................................44
III. EPA Unlawfully Denied NRDCs Request for an
Evidentiary Hearing on Material Factual Issues
Concerning the Scientific Reliability of the Dichlorvos
Human Study and the Existence of Informed Consent ................................. 46

iv

A. The Food Act and EPAs Implementing Regulations
Require EPA to Conduct an Evidentiary Hearing to
Resolve Genuine, Material, and Substantial Issues of
Fact .............................................................................................................47
B. The Food Act Entitles NRDC to a Hearing to
Determine Whether the Dichlorvos Human Study Was
Conducted Without the Informed Consent of Its
Subjects ......................................................................................................49
C. NRDC Was Entitled to a Hearing to Determine
Whether the Dichlorvos Human Study Was
Scientifically Unreliable ............................................................................55
CONCLUSION ........................................................................................................ 64
CERTIFICATE OF COMPLIANCE ....................................................................... 65


v

TABLE OF AUTHORITIES
CASES
Adams v. EPA,
38 F.3d 43 (1st Cir. 1994) ..............................................................................37
Alabama-Tombigbee Rivers Coal. v. Dept of Interior,
26 F.3d 1103 (11th Cir. 1994) .......................................................................43
Am. Cyanamid Co. v. FDA,
606 F.2d 1307 (D.C. Cir. 1979) .............................................................. 46, 61
Anderson v. Liberty Lobby, Inc.,
477 U.S. 242 (1986).......................................................................................48
Baur v. Veneman,
352 F.3d 625 (2d Cir. 2003) ..........................................................................31
Bellevue Hosp. Ctr. v. Leavitt,
443 F.3d 163 (2d Cir. 2006) ..........................................................................62
Chambers v. TRM Copy Ctrs. Corp.,
43 F.3d 29 (2d Cir. 1994) ..............................................................................52
Chevron U.S.A., Inc. v. NRDC,
467 U.S. 837 (1984).......................................................................... 37, 44, 46
Citizens for Jazz on WRVR, Inc. v. FCC,
775 F.2d 392 (D.C. Cir. 1985) .......................................................................49
City of Wausau v. United States,
703 F.2d 1042 (7th Cir. 1983) .......................................................................37
Cmty. Nutrition Inst. v. Young,
773 F.2d 1356 (D.C. Cir. 1985) .............................................................. 36, 60
DeNeui v. Wellman,
No. Civ. 07-4172, 2009 WL 4847086 (D.S.D. Dec.
9, 2009) ..........................................................................................................50

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Friends of the Earth v. Laidlaw Envtl. Servs.,
528 U.S. 167 (2000)................................................................................ 29, 31
Gen. Dynamics Land Sys. v. Cline,
540 U.S. 581 (2004).......................................................................................46
Gen. Motors Corp. v. Fed. Energy Regulatory Commn,
656 F.2d 791 (D.C. Cir. 1981) .......................................................................32
Hunt v. Wash. State Apple Adver. Commn,
432 U.S. 333 (1977)................................................................................ 29, 33
Hynson, Westcott & Dunning, Inc. v. Richardson,
461 F.2d 215 (4th Cir. 1972) ............................................................ 36, 61, 62
Midwestern Gas Transmission Co. v. Fed. Energy
Regulatory Commn,
589 F.2d 603 (D.C. Cir. 1978) .......................................................................32
Motor Vehicle Mfrs. Assn v. State Farm Mut. Auto. Ins.
Co.,
463 U.S. 29 (1983).........................................................................................36
N.Y. Pub. Interest Grp. v. Whitman,
321 F.3d 316 (2d Cir. 2003) ..........................................................................31
Natl Assn of Home Builders v. Defenders of Wildlife,
551 U.S. 644 (2007).......................................................................................39
Natl Corn Growers Assn v. EPA,
613 F.3d 266 (D.C. Cir. 2010) .......................................................................37
NRDC v. EPA,
658 F.3d 200 (2d Cir. 2011) .................................................................. passim
OHara v. Natl Union Fire Ins. Co. of Pittsburgh,
642 F.3d 110 (2d Cir. 2011) ..........................................................................48
Pactra Indus. v. Consumer Prod. Safety Commn,
555 F.2d 677 (9th Cir. 1977) .........................................................................61

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Rainwater v. Alarcon,
268 F. Appx 531 (9th Cir. 2008) ..................................................................50
Ratanasen v. Cal. Dept of Health Servs.,
11 F.3d 1467 (9th Cir. 1993) .................................................................. 58, 60
United States v. FCC,
652 F.2d 72 (D.C. Cir. 1980) .........................................................................37
Waterkeeper Alliance v. EPA,
399 F.3d 486 (2d Cir. 2005) ................................................................... 35, 37
Weinberger v. Hynson, Westcott & Dunning, Inc.,
412 U.S. 609 (1973)................................................................................ 36, 37
STATUTES
Federal Food, Drug, and Cosmetic Act
21 U.S.C. 342(a)(2)(B) ........................................................................................... 6
21 U.S.C. 342(a)(4) ................................................................................................. 6
21 U.S.C. 346a(a)(1) ............................................................................................... 6
21 U.S.C. 346a(b)(2)(A)(i) ...................................................................................31
21 U.S.C. 346a(b)(2)(A)(ii) .................................................................................... 6
21 U.S.C. 346a(b)(2)(C) ......................................................................................... 8
21 U.S.C. 346a(b)(2)(C)(ii)(II) ............................................................................... 9
21 U.S.C. 346a(d) .......................................................................................... 27, 47
21 U.S.C. 346a(g) .................................................................................................27
21 U.S.C. 346a(g)(2) .............................................................................................27
21 U.S.C. 346a(g)(2)(A)-(B) ................................................................................47
21 U.S.C. 346a(g)(2)(B) ............................................................................... passim
21 U.S.C. 346a(h)(1) ............................................................................................... 1

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21 U.S.C. 346a(q)(1) ............................................................................................... 9
21 U.S.C. 348(f)(1)) ..............................................................................................37
Federal Insecticide, Fungicide, and Rodencticide Act
7 U.S.C. 136(bb) .................................................................................................6, 7
7 U.S.C. 136a(a) ...................................................................................................... 6
7 U.S.C. 136a(c)(5)(C) ........................................................................................6, 7
Department of the Interior, Environment, and Related
Agencies Appropriations Act of 2006,
Pub. L. No. 109-54, 201, 119 Stat. 499 .............................................. passim
5 U.S.C. 706(2)(A) ................................................................................................35
47 U.S.C. 309(d)(2)...............................................................................................49
REGULATIONS
40 C.F.R. 26.1602(b)(2) ........................................................................................23
40 C.F.R. 26.1603 .................................................................................................17
40 C.F.R. 26.1603(b) ............................................................................................23
40 C.F.R. 26.1701 .......................................................................................... 54, 62
40 C.F.R. 26.1704 ......................................................................................... passim
40 C.F.R. 178.32(b) ........................................................................... 46, 48, 49, 54
40 C.F.R. 178.32(b)(1) ............................................................................. 58, 59, 63
40 C.F.R. 178.32(b)(2) .................................................................................. passim
40 C.F.R. 178.32(b)(3) ............................................................................. 54, 62, 63
40 C.F.R. 179.24 ...................................................................................................62
40 C.F.R. 179.60 ............................................................................................ 47, 62

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40 C.F.R. 179.70 ...................................................................................................47
40 C.F.R. 179.85 ............................................................................................ 47, 49
40 C.F.R. 179.93 ............................................................................................ 47, 49
40 C.F.R. 179.105(a) .............................................................................................47
60 Fed. Reg. 50,338 (Sept. 28, 1995) ......................................................................19
70 Fed. Reg. 6661 (Feb. 8, 2005) ............................................................................12
71 Fed. Reg. 6138 (Feb. 6, 2006) ........................................................... 9, 10, 16, 17
72 Fed. Reg. 68,662 (Dec. 5, 2007) ................................................................. passim
73 Fed. Reg. 42,683 (July 23, 2008) ................................................................ passim
76 Fed. Reg. 5735 (Feb. 2, 2011) ............................................................................18
77 Fed. Reg. 54,402 (Sept. 5, 2012) ................................................................ passim
LEGISLATIVE HISTORY
151 Cong. Rec. H3671 (May 19, 2005) ............................................................ 13, 45
151 Cong. Rec. H7013-7023 (July 28, 2005) .................................................. passim
151 Cong. Rec. S7551-7561 (June 29, 2005) .................................................. passim
Minority Staff of the Special Investigations Division of
the House Committee on Government Reform &
Office of Senator Barbara Boxer, Human Pesticide
Experiments (2005) .......................................................................... 10, 20, 42
Minority Staff of the Special Investigations Division of
the House Committee on Government Reform,
Flash Report: New EPA Proposal Encourages
Human Pesticide Experiments (2005) .................................................... 15, 42
OTHER AUTHORITIES
EPA Human Studies Review Board, April 4-6, 2006
Meeting Report (June 26, 2006) ............................................................ passim

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EPA Office of Prevention, Pesticides and Toxic
Substances, Initial Ethics Review of DDVP
Human Study (Mar. 16, 2006) ............................................................... passim
EPA, Final Agency Review DRAFT, Protections for Test
Subjects in Human Research; Proposed Rule (June
20, 2005) ........................................................................................... 13, 14, 40
National Academy of Sciences, Intentional Human
Dosing Studies for EPA Regulatory Purposes
(2004) ..................................................................................................... passim
COURT RULES
Fed. R. App. P. 26.1 .................................................................................................. ii
Fed. R. Civ. P. 56 .....................................................................................................48



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LIST OF ACRONYMS AND ABBREVIATIONS
The Academy The National Academy of Sciences
The Board Human Studies Review Board
DDVP Dichlorvos
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
Food Act Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act of 1996
NRDC Natural Resources Defense Council
Section 201 Section 201 of the Department of the Interior, Environment,
and Related Agencies Appropriations Act of 2006


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JURISDICTIONAL STATEMENT
This Court has jurisdiction under the Federal Food, Drug, and Cosmetic Act
(Food Act), which provides that any person who will be adversely affected by an
order denying pesticide objections and a request for an evidentiary hearing may
file a petition for review in the appropriate circuit court of appeals. 21 U.S.C.
346a(h)(1). The U.S. Environmental Protection Agency (EPA) issued a final
order on September 5, 2012 (2012 order) denying objections and a hearing request
filed by Petitioner Natural Resources Defense Council (NRDC) concerning the
pesticide dichlorvos. SPA-001; see also infra, Statement of Facts VI.
This petition was timely filed within sixty days of publication of the 2012
order. 21 U.S.C. 346a(h)(1); SPA-147. This venue is appropriate because NRDC
resides and maintains its principal place of business in New York. 21 U.S.C.
346a(h)(1); SPA-152 (Lopez Decl. 3). NRDC has standing to bring this
petition, as discussed below. See infra, Standing.
STATEMENT OF ISSUES
1. Did EPA violate Section 201 of the Department of the Interior,
Environment, and Related Agencies Appropriations Act of 2006 (Section 201),
Pub. L. No. 109-54, 201, 119 Stat. 499, 531, by using a study in which humans

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were intentionally dosed with dichlorvos that was deficient relative to the ethical
standards prevailing at the time the study was conducted?
2. Was EPAs denial of NRDCs request under the Food Act, 21 U.S.C.
346a(g)(2)(B), for an evidentiary hearing on disputed factual issues concerning
whether the studys participants gave their informed consent to be dosed with
dichlorvos and whether the study was scientifically reliable, arbitrary and
capricious and contrary to law?
STATEMENT OF THE CASE
The pesticide dichlorvos, also known as DDVP, is a potent neurotoxin and a
likely carcinogen. A-486, 536-37, 545. In 1997, the sole United States
manufacturer of dichlorvos funded a study in which six young men swallowed pills
containing dichlorvos each morning for twenty-one days, to measure the
pesticides toxic effects on the nervous system. A-414, 418, 673-74, 702. The
manufacturer commissioned the study to gather data that could support the
continued sale of dichlorvos, A-418, 451, following 1996 amendments to the Food
Act that required pesticides to meet a more protective margin of safety. Id.; NRDC
v. EPA, 658 F.3d at 202-03. EPAs assessment of the health risks affect the
pesticide levels EPA may allow to remain as residues on food crops and to be used

3

in other products, like home insecticides. NRDC v. EPA, 658 F.3d at 203-04; infra,
Statement of Facts I.
In 2005, Congress passed Section 201, which requires EPA to follow
scientific and ethical principles proposed by the National Academy of Sciences in
deciding what human studies it may use in its pesticide regulatory work. SPA-116;
infra, Statement of Facts III. With respect to human studies in existence before
EPAs adoption of regulations implementing Section 201, the statute bars EPA
from using studies that are deficient relative to the ethical standards prevailing at
the time such studies were conducted. Infra, Argument II.A.
EPA has twice reviewed the dichlorvos human study and found
deficien[cies] relative to then-prevailing ethical standards. A-413 to 417, 678-82.
The deficiencies identified by EPA include the study investigators use of
misleading consent forms that may have led the subjects dosed with dichlorvos to
believe they were ingesting a medical drug, not a pesticide. A-414 to 415, 680-81;
infra, Statement of Facts V.A. EPA also found substantial scientific flaws in the
study, flaws that led its Human Studies Review Boarda body established
pursuant to Section 201 and charged with evaluating human studies conducted by
third parties and submitted to EPAto conclude the study had at best limited . . .

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value for EPAs regulatory decisionmaking. A-456, 674-76, 680; infra, Statement
of Facts V.B.
Despite its own findings that the dichlorvos human study was ethically
deficient and scientifically flawed, EPA used and relied on the study to leave in
place regulations that allow widespread use of and human exposure to dichlorvos.
See infra, Statement of Facts V.C; see also NRDC v. EPA, 658 F.3d at 207
(surveying approved uses of dichlorvos).
To protect its members and the public from the health risks posed by
dichlorvos and to prevent EPA from continuing to rely on an unethical and
statistically invalid human study to authorize dichlorvoss continued use, NRDC in
2006 petitioned EPA under the Food Act to revoke regulatory approvals for
dichlorvos. NRDC v. EPA, 658 F.3d at 205. EPA denied that petition and, in a final
order in 2008 (2008 order), denied NRDCs subsequent administrative objections
to EPAs dichlorvos approvals and request for an evidentiary hearing on specific
ethical and scientific flaws in the dichlorvos study. A-695; SPA-021. NRDC
petitioned for review of EPAs 2008 order in this Court, which in 2011 vacated in
part and remanded to EPA. On September 5, 2012, following remand, EPA issued

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a second final order in which it once again denied NRDCs objections and
evidentiary hearing request (2012 order).
1
SPA-001.
This petition challenges the 2012 order on two grounds. First, EPA has
violated Section 201 by using an ethically deficient human study. Second, EPA has
arbitrarily denied NRDCs request for an evidentiary hearing, under the Food Act,
on material factual issues concerning the adequacy of the dichlorvos human
studys informed consent procedure and the studys statistical validity. 21 U.S.C.
346a(g)(2)(B).
2
This Court should accordingly vacate EPAs 2012 order. The
Court should also prevent EPA from relying on the human study or, in the
alternative, order EPA to grant NRDCs hearing request.




1
The 2012 order was signed by Steven Bradbury, Director of EPAs Office of
Pesticide Programs. SPA-020.
2
NRDC presented this evidentiary hearing issue in its 2008 petition for review
in this Court, but this Court did not reach the issue because it granted NRDCs
petition and vacated and remanded the relevant portions of EPAs 2008 order on
another ground. See infra, Statement of Facts VI; NRDC v. EPA, 658 F.3d at 219.

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STATEMENT OF FACTS
I. The Food Act Requires EPA to Assess Pesticides Risks to Human
Health and to Prevent the Sale of Unsafe Pesticides

The Food Act prohibits the sale of food containing pesticide residue unless
EPA has set a tolerance, or maximum limit, for the pesticide in or on the food,
and the level of pesticide residue falls below the regulatory limit. 21 U.S.C.
342(a)(2)(B), 346a(a)(1), (4). EPA may establish or leave in place a tolerance
on a food only if EPA determines it is safe. Id. 346a(b)(2)(A)(ii). A tolerance
is safe for purposes of the Act if there is a reasonable certainty that no harm to
humans will result from aggregate exposure to the pesticide, which includes all
non-dietary exposures. Id. 346a(b)(2)(A)(ii). This standard governs both EPAs
establishment of tolerances and its denials of administrative petitions to revoke
tolerances under the Food Act. SPA-003 (col. 1).
EPA also regulates pesticides under a second, related statute, the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), which requires EPA to
register pesticides before they can be sold or distributed in the United States. 7
U.S.C. 136a(a). In determining whether a pesticide may be registered under
FIFRA, EPA must consider whether the pesticide is safe under the Food Act. Id.
136(bb), 136a(c)(5)(C). FIFRA prevents EPA from registering (or reregistering)

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a pesticide if this would cause unreasonable adverse effects on the environment.
Id. 136a(c)(5)(C). Those effects include human dietary risk from residues that
result from a use of a pesticide in or on any food inconsistent with the standard
under [the Food Act]. Id. 136(bb). EPAs regulatory assessment of a pesticides
risks under the Food Act can therefore affect how the pesticide is used both on
food crops and in other products (such as home insecticides) regulated through
FIFRA.
To assess the risk to humans of aggregate exposure to a pesticide, EPA
generally reviews the results of laboratory animal studies designed to measure the
pesticides toxicity to animals. SPA-023 (col. 3) to 024 (col. 1). EPA uses these
animal studies to set a level of exposure to the pesticide that EPA determines has
been shown not to cause harm to animals, called the no effects dose. SPA-024
(col. 2). Where the available data from animal studies do not allow EPA to
determine a no effects dose, EPA instead estimates that dose by extrapolating
from available information on the lowest dose shown to cause harm in animals
called the low effects dose. SPA-005 to 007, 024 (col. 2), 033 (col. 3); see also
NRDC v. EPA, 658 F.3d at 207-08.
This no (or low) effects dose is the starting point for EPAs assessment of
what health risks the pesticide poses to humans who may be exposed through

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various pathways, such as ingestion of pesticide residues on food or in drinking
water or inhalation of vapors from insecticide strips used in homes. SPA-024 (cols.
2-3), 029 (col. 2) (both discussing starting point, or point of departure); A-489
(discussing exposure scenarios). EPA then typically applies one or more safety
factors intended to account for uncertainties in the experimentally-derived data that
limit the datas reliability as a means of determining what exposure levels are
safe for all humans. NRDC v. EPA, 658 F.3d at 208; SPA-004.
Until 1996, EPA typically applied two basic types of uncertainty factors.
NRDC v. EPA, 658 F.3d at 208; SPA-004 (col. 2). First, to account for the fact that
the laboratory animals on which pesticides are usually tested may be less sensitive
to those pesticides than humans would be, EPA applied an interspecies safety
factor. SPA-004 (col. 2). Second, to account for the fact that individuals may differ
widely in their sensitivity to a particular pesticide, EPA increased the target margin
of exposure by a second, intraspecies safety factor. Id.
In the Food Quality Protection Act of 1996 (FQPA), Congress amended the
Food Act to require EPA to apply an additional safety factor to account for the fact
that children may be significantly more vulnerable to pesticide exposures than
adults. 21 U.S.C. 346a(b)(2)(C); NRDC v. EPA, 658 F.3d at 202-04. The FQPA
now requires EPA to reduce by tenfold the levels of pesticide exposure it would

9

have deemed safe based on other considerations to help ensure that its final
regulatory approvals are safe for children.
3
21 U.S.C. 346a(b)(2)(C); NRDC v.
EPA, 658 F.3d at 203, 208; A-040. The FQPA also required EPA to reassess its
existing pesticide approvals to ensure that they remain lawful under the Food Act
after accounting for this new, Congressionally mandated childrens safety factor.
21 U.S.C. 346a(q)(1).
II. The National Academy of Sciences Has Proposed Principles to Restrict
EPAs Use of Studies Intentionally Exposing Humans to Pesticides

The additional margin of safety Congress mandated in the FQPA caused
concern among some pesticide manufacturers that, upon reassessment, certain
long-used pesticides would no longer qualify as safe under the Food Act and
FIFRA and could no longer be sold or distributed in the United States. A-039, 040
(National Academy of Sciences account of manufacturers concerns that certain
pesticide uses . . . might otherwise have been precluded under FQPAs new safety
standards), 397 (col. 1). In an effort to help ensure continued sales of their
products, some pesticide manufacturers submitted studies that deliberately exposed
humans to pesticides. A-039 to 040, 346 (col. 3) (submission of human toxicity

3
The FQPA allows EPA to use a value different than ten for the childrens
safety factor only where reliable data for a particular pesticide shows a different
value will be sufficiently protective. 21 U.S.C. 346a(b)(2)(C)(ii)(II).

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studies was rare pre-FQPA and increased after its passage, with twenty or
more studies submitted since 1996), 397 (col. 1) (Much third-party research is
conducted by private, for profit organizations in the hope that the results will lead
to financial benefits, often through changes in government regulation.). These
human dosing studies were submitted in an effort to develop data that might
justify reducing the interspecies uncertainty factor EPA typically applies when it
must extrapolate from animal studies, and thereby permit[] the continuation of
certain pesticide uses that otherwise would not meet the Food Acts strict standard
of safety. A-040 to 041; see also A-039, 397 (col. 1), 451; SPA-133 (col. 1). Some
pesticide manufacturers have paid human subjects to eat or drink pesticides, to
enter pesticide vapor chambers, and to have pesticides sprayed into their eyes or
rubbed onto their skin. A-305 to 308, 328-31.
When initially faced with the question of whether to use these intentional
human dosing studies in its regulatory work, EPA declared that it did not need the
results of human tests to safely regulate pesticides, and that [t]he protection of
public health from adverse effects of pesticides can be achieved through reliance
on animal testing and use of the highest ethical standards. A-743 (quoting EPAs
July 27, 1998 statement); see also A-041. EPA also sought the guidance of the
National Academy of Sciences, an organization Congress chartered to advise the

11

federal government on scientific matters. A-017 to 019, 022. EPA asked the
Academy to provide recommendations to [EPA] to help address the scientific and
ethical questions related to . . . research involving deliberate exposure of human
subjects to toxicants when used to identify or quantify toxic endpoints. A-017.
The Academy responded to EPAs charge by launching an inquiry to
determine whether and, if so, under what circumstances EPA should accept and
consider intentional human dosing studies conducted by companies or other
sources outside the agency . . . to gather evidence relating to the risks of a
chemical . . . . A-038. In 2004, the Academy concluded its investigation and
published a report (Report) that sets out seventeen specific principles, which the
Report enumerates as Recommendations. A-020 to 021, 043-57. Several of those
principles address EPAs use of human dosing studies. The Academy concluded
that as a general rule, EPA should not use data from ethically problematic studies
to inform its regulatory efforts. A-163. With respect to human studies already in
existence, the Academy proposed a specific standard, labeled Recommendation 5-
7 in its Report, that reads in relevant part:
EPA should accept scientifically valid studies conducted
before its new rules are implemented unless there is clear
and convincing evidence that the conduct of those studies
was fundamentally unethical (e.g., the studies were
intended to seriously harm participants or failed to obtain

12

informed consent) or that the conduct was deficient
relative to then-prevailing ethical standards.

A-167 (emphasis added) (footnote omitted). The Report proposed additional
principles to govern which future human studies EPA should deem acceptable for
use in regulatory decisions. A-163 to 166.
III. Congress Passed Section 201 to Restrict EPAs Use of Studies
Intentionally Exposing Humans to Pesticides

Not long after the Academy published its 2004 Report, EPA issued a
proposed plan for its consideration of human tests in pesticide regulation in
which it promised to consider the Report, but made no commitment to follow the
Reports Recommendations. A-274 (col. 2). EPA also said it would propose a rule
to govern its use of newly conducted human studies and consider whether to
propose a rule applying to certain previously conducted human studies. A-274
(cols. 1-2). EPA also advised that until such time as it chose to adopt a rule, it
planned to generally accept previously conducted studies it deemed scientifically
valid unless there is clear evidence that the conduct of those studies was
fundamentally unethical . . . or was significantly deficient relative to the ethical
standards prevailing at the time the study [sic] was conducted. Id. (emphasis
added).

13

Just months after EPA announced its proposed plan, the House of
Representatives passed an amendment to EPAs appropriations bill for 2006 that
would have placed a moratorium on any EPA use of human dosing studies for
pesticides. SPA-120 to 121. The amendments sponsors expressed displeasure that
EPA has chosen to go against the recommendation of the National Academy of
Sciences. SPA-121 (cols. 1-2) (statement of Rep. Solis). Concerned that EPA
would continue to accept and use the results of human studies which fail to meet
minimum international standards, to the detriment of public health, the sponsors
crafted the amendment to bar EPAs use of such studies until EPA put binding
safeguards in place. Id. (col. 2).
Despite this expression of disapproval, EPA developed a Final Agency
Review Draft (or draft rule) of a proposed regulation on use of human pesticide
studies that departed from key Recommendations of the National Academy of
Sciences. See A-333 to 340 (draft rule); SPA-141 (col. 2) (statement of Sen.
Clinton). With respect to Recommendation 5-7, in which the Academy proposed
that EPA reject previously conducted studies that were ethically deficient
relative to then-prevailing ethical standards, EPA stated that it had modified the
Academys standard. A-337. EPAs draft rule proposed that EPA reject such
studies only if it determined they were significantly deficient compared to then-

14

prevailing ethical standards. Id. (emphasis added). EPA explained that this change
reflects EPAs viewnot the view of the National Academythat refusing to
rely on data . . . should be reserved for the most egregious of conduct. Id.
(emphasis added).
Less than two weeks after EPA developed its draft rule, the Senate took up
the issue of EPAs use of third-party human tests. The Senate passed an
amendment to EPAs 2006 appropriations bill that, like the House amendment
discussed above, would have prohibited EPAs use of all third-party intentional
dosing human studies for pesticides. SPA-138 (col. 1), 146. Senators criticized the
standard EPA intended to propose as in direct contradiction to the key
recommendations made by the National Academy of Sciences. SPA-141 (col. 2)
(statement of Sen. Clinton). The underlying concern, expressed again and again
during the floor debate, was that the previously conducted studies testing pesticides
on humans should not be used by EPA due to the studies many ethical and
scientific faults. See, e.g., id. (statement of Senator Clinton denouncing studies that
failed to obtain informed consent, inflicted harm on the human subjects, . . . or
failed to conduct long-term monitoring), SPA-144 (col. 1) (statement of Senator
Obama criticizing EPAs consideration of data from human studies that were not

15

scientifically valid, failed to take the health complaints of the subjects
seriously, and failed to disclose the risk to the subjects).
During further debate on the conference report for the 2006 appropriations
bill, Members of Congress expressly chided EPAs draft rule for its insertion of the
word significantly to modify the National Academys proposal that EPA reject
all older studies that were deficient relative to then-prevailing ethical standards.
SPA-133 (col. 1); A-284 to 285 (report submitted into Congressional record). The
House sponsor of the legislation submitted a report into the record that stated that
this change would permit EPA to continue relying on old unethical studies in
contravention of the National Academy of Sciences recommendation. A-284 to
285; SPA-133.
Congresss final 2006 appropriations bill for EPA includes a provision that
bans EPAs use of outside human studies until EPA adopts a regulation adhering to
the Recommendations made by the National Academy of Sciences. The provision,
entitled Section 201, states in relevant part:
Sec. 201. None of the funds made available by this Act
may be used by the Administrator of the Environmental
Protection Agency to accept, consider, or rely on third-
party intentional dosing human toxicity studies for
pesticides, or to conduct intentional dosing human
toxicity studies for pesticides until the Administrator
issues a final rulemaking on this subject . . . . Such rule

16

shall not permit the use of pregnant women, infants or
children as subjects; shall be consistent with the
principles proposed in the 2004 report of the National
Academy of Sciences on intentional human dosing and
the principles of the Nuremberg Code with respect to
human experimentation; and shall establish an
independent Human Subjects Review Board.

Department of the Interior, Environment, and Related Agencies Appropriations
Act of 2006, Pub. L. No. 109-54, 201, 119 Stat. 499, 531 (emphasis added).
IV. EPAs Human Testing Rule Permits EPA to Use Ethically Deficient
Human Dosing Studies, Contrary to Section 201 and the National
Academys Recommendations

In 2006, EPA issued a final regulation known as the Human Testing Rule.
A-373 (codified at 40 C.F.R. Parts 9 and 26). The Rule, like the draft rule EPA
completed shortly before Congress enacted Section 201, purports to allow EPA to
use human studies conducted before adoption of the Rule unless there is clear and
convincing evidence that either the conduct of the study was fundamentally
unethical or was significantly deficient relative to the ethical standards prevailing
at the time the research was conducted. 40 C.F.R. 26.1704 (emphasis added).
In its Federal Register notice adopting the Rule, EPA explained that it did not
consider itself bound by Section 201 to adopt standards consistent with the
seventeen principles, called Recommendations, that comprise the core of the
National Academys 2004 Report. A-400 (cols. 1-2). EPA conceded that Section

17

201 requires it to adopt a rule that is consistent with the principles proposed in the
2004 report of the National Academy of Sciences. Id. (col. 1); SPA-116. EPA
asserted, however, that it read Congresss reference to principles proposed in the
2004 report to refer not to the Academys seventeen proposed principles, but to
three much vaguer concepts (beneficence, justice, and respect for persons)
identified in a 1979 document called the Belmont Report and mentioned by the
Academy in scattered background portions of its 2004 Report. A-087 to 088, 094,
149, 151-53, 400 (cols. 1-2). EPA then explained that it understood the Rule to be
consistent with the concepts of beneficence, justice, and respect for persons.
A-400 (col. 2).
The Rule also established a Human Studies Review Board, consisting of
EPA-appointed members, to review and comment on the scientific and ethical
aspects of human studies submitted to EPA. 40 C.F.R. 26.1603; SPA-028 (col.
3).
A coalition of public health and farmworker rights organizations, including
NRDC, challenged the Human Testing Rule as contrary to Section 201; their
petitions for review were consolidated in this Court. See NRDC v. EPA, Nos. 06-
0820-ag (L), 06-1895-ag (CON), 06-2149-ag (CON), 06-2360-ag (CON) (lead
petition filed Feb. 23, 2006). Petitioners argued, among other things, that the

18

Rules significantly deficient threshold for rejection of older studies made it
inconsistent with Recommendation 5-7 in the National Academys Report, and
accordingly violated Congresss mandate to EPA to adopt a rule consistent with
the principles proposed in the Report. The parties reached a settlement, pursuant to
which EPA agreed to propose an amendment to the Rule that would remove the
term significantly from the standard regulating agency use of previously
conducted human dosing studies. See 76 Fed. Reg. 5735, 5740-41, 5750 (Feb. 2,
2011) (discussing settlement). EPA agreed to take final action adopting the
amended Rule by December 18, 2011. Id. at 5741 (col. 1). Although EPA did
propose the amendment, id. at 5735, the settlement deadline for finalizing the
proposal passed over a year ago, and EPA has never finalized the amendment.
V. EPA Used a Study Testing Dichlorvos on Humans to Assess the
Pesticides Safety, in Reliance on Its Unlawful Human Testing Rule

Dichlorvos was developed from World War II nerve warfare agents. A-599.
It is now widely used to kill insects. A-486. People may become exposed to
dichlorvos by inhaling vapors from no-pest strips sold for home use; by
ingesting dichlorvos residues on food and in drinking water; and by coming into
contact with dichlorvos used in picnic areas, parking lots, and other outdoor

19

spaces, as well as in restaurants, theaters, and other building interiors. A-486, 517,
519, 527, 563-64, 599.
Exposure to dichlorvos can seriously harm humans. EPA has recognized that
dichlorvos interferes with the normal functioning of the nervous system, impairing
the function of a critical enzyme called cholinesterase that facilitates
communication among nerve cells. A-523, 536-37, 599, 601. Other health effects
associated with dichlorvos exposure range from vomiting, diarrhea, sweating, and
muscle twitching to more serious symptoms like seizures, loss of consciousness,
and death. A-549 to 550, 599.
Dichlorvos also has been connected to increased rates of cancer in both
humans and animals. A-599 (use of dichlorvos no-pest strips in home linked to
three-fold increased risk of leukemia in children under age fifteen); A-545 (EPA
finding that dichlorvos is suggestive of cancer in humans); 60 Fed. Reg. 50,338,
50,338 (Sept. 28, 1995) (EPA conclusion that dichlorvos poses carcinogenic
risks). California has classified dichlorvos as a known human carcinogen. A-599.
In 2006, following a reassessment of dichlorvoss health risks mandated by
the FQPA, see supra, Statement of Facts I, EPA decided to sanction the continued
sale of dichlorvos. SPA-029 (col. 3); A-527. In reaching this decision, EPA relied
on data from an unpublished study, conducted one year after Congress amended

20

the Food Act in 1996 to require more stringent regulation of pesticides, in which
humans were intentionally dosed with dichlorvos (dichlorvos human study) to
measure its toxic effects on the tested subjects nervous systems. SPA-008 (col. 3),
041 (cols. 2-3).
4

The chemical company Amvac, the sole U.S. manufacturer of dichlorvos,
funded the human study to supply data that could support reduction of the tenfold
interspecies safety factor. A-414, 418, 451, 702. The study was conducted overseas
and authored by A.J. Gledhill. A-413; SPA-030 (col. 1). The tested subjectssix
young, healthy, white maleswere paid 330 pounds sterling (about $500) each to
swallow pesticide pills each morning for three weeks. A-414, 673-74. Blood
samples were collected from the subjects to measure dichlorvoss inhibition of
cholinesterase, an enzyme critical to nervous system functioning. A-674.
The dichlorvos human study was one of the human dosing studies that Congress
specifically condemned for its ethical and scientific defects in the debate that led
up to its enactment of Section 201. See SPA-132 (col. 3) to 133 (col. 1), 138 (col.
3); A-310, 316, 319-21, 326-27.

4
This study is entitled Dichlorvos: A Single Blind, Placebo Controlled,
Randomized Study to Investigate the Effects of Multiple Oral Dosing on
Erythrocyte Cholinesterase Inhibition in Healthy Male Volunteers (MRID
44248801) (Mar. 24, 1997).

21

A. EPAs Office of Pesticides Reviewed and Identified Ethical
Deficiencies in the Dichlorvos Human Study

In 2006, EPAs Office of Prevention, Pesticides and Toxic Substances
(Pesticide Office) conducted an initial review of whether the dichlorvos human
study complied with ethical standards prevailing at the time the study was
conducted. A-413. EPA identified the World Medical Associations Declaration of
Helsinki of 1989 as the source of ethical standards prevailing at the time the
dichlorvos human study was conducted and reviewed the study against those
standards. A-413 to 415.
EPA noted several serious ethical problems with the study, including with its
procedure for obtaining the informed consent of its human subjects. First, EPA
found that the consent form and accompanying materials employed by the study
investigator may well have misled subjects into thinking they were participating
in a drug trial rather being dosed with a toxic pesticide. A-415. For example, the
boilerplate consent form referred to dichlorvos as the drug and did not identify it
as a pesticide. Id. The form also stated that the studys purpose was the
acquisition of medical knowledge and said its results might be disclosed to
regulatory authorities for medicines. Id. The notes accompanying the form

22

incorrectly called dichlorvos a trial drug[] and referred repeatedly to drugs you
will be receiving. Id.
EPA also found other ethical deficiencies in the consent materials. For
example, the consent form included a statement that the human health risks the
study posed to its test subjects are very unlikely to occur, and a suggestion that
an antidote would be available if harm did befall a subject. Id. The form did not
identify Amvac (dichlorvoss manufacturer) as the studys sponsor. Id. Despite
these numerous deficiencies, EPA concluded informed consent was obtained
because the notes to the consent form elsewhere described dichlorvos as an
insecticide, and subjects were given a twenty-four-hour waiting period before
being asked to sign the consent forms. A-414 to 415.
In addition to problems with the studys consent materials, EPA identified a
host of other apparent ethical deficiencies in the way the study was conducted,
relative to the principles of the Declaration of Helsinki. A-415 to 417 (quotes at
415). Among the more serious transgressions, EPA found that the studys
investigator failed to follow its own predetermined criteria for withdrawing the test
subjects from further testing when their neurotoxic impairment reached levels of
concern. A-415 to 416. Other ethical deficiencies described by EPA included
inadequate medical monitoring of the subjects, who were released from the clinic

23

each day after swallowing the pesticide pill (rather than held for observation). A-
416. EPA also found deficien[t] the studys failure to establish that the
committee charged with reviewing the adequacy of the study procedure was
independent from the pesticide manufacturer and study investigator. Id. According
to EPA, ethical violations in the conduct of the study reflected little consideration
for the well-being of the subjects. A-415 to 416. EPA deferred deciding the
overall significance of the identified deficiencies in the study until further
analysis by EPAs Human Studies Review Board. A-417.
B. EPAs Human Studies Review Board Identified Ethical and
Statistical Deficiencies in the Dichlorvos Human Study

The Human Studies Review Board next considered the dichlorvos human
study and issued a report advising EPA of its findings, pursuant to EPAs Human
Testing Rule. See 40 C.F.R. 26.1602(b)(2), 26.1603(b). To assess whether EPA
could use the study for regulatory decision making, the Board applied the relevant
standard from the Rule. See id. 26.1704. Specifically, the Board looked for clear
and convincing evidence that the conduct of the dichlorvos study was
significantly deficient relative to the ethical standards prevailing at the time. A-
671 (emphasis in original); accord A-679; see also 40 C.F.R. 26.1704.

24

In its report, the Board agreed with the author of EPAs initial ethics review
that the study had several clear deficiencies when measured against the ethical
standards prevailing at the time the study was carried outi.e., the Declaration of
Helsinki. A-679 to 682 (quote at 681). The Board found that the studys consent
materials failed to fully meet the standards of voluntary informed consent
followed at the time. A-680. The Board also found that medical monitoring of the
human subjects who were fed pesticide pills was inadequate. Id. The Board
concluded that the study failed to fully meet the specific ethical standards
prevalent at the time the research was conducted. A-665. Nonetheless, the Board
offered its tepid endorsement of the study. A-457. The Board did so, it
explained, because the studys ethical violations did not reach the threshold of
significantly deficient under the Human Testing Rule. Id.; see also A-665.
In addition to commenting on the studys serious ethical shortcomings, the
Board called into question the studys ability to supply EPA with reliable data
about dichlorvoss toxicity. The Board identified numerous weaknesses in the
study design and execution. A-674 to 675. It also criticized as small the studys
sample size of six young, white, male test subjects, and three control subjects. Id.
The Board also found that it was not clear whether the study was properly
powered, given that no sample size calculations seem to have been used in order to

25

arrive at the number of volunteers used in the study. Id. The Board concluded that
the low number of subjects studied greatly limited the study[s] value for the
regulatory process. A-455 to 456.
The Board also discussed another problem first identified in EPAs initial
ethics review: the study investigators failure to continue to medically monitor
certain test subjects whose levels of nervous system impairment reached levels of
concern, while exposing them to further doses of the toxin. A-456; see also A-675
to 676. The Board concluded that this conduct was not scientifically defensible.
A-456; see also A-675 to 676. Although the Board recognized the study had
numerous weaknesses in its design and execution that called into question the
studys reliability as a source of information about dichlorvos, it allowed EPA to
use the study for its dichlorvos risk assessment. A-674, 676 (also finding the
scientific limitations of the study design were too great to justify the studys use
for a different, cumulative pesticide risk assessment process).
C. EPA Relied on the Dichlorvos Human Study to Authorize
Continued Use of Dichlorvos

As part of a reassessment of the health risks of dichlorvos mandated by the
1996 Food Act amendments, EPA applied the Human Testing Rules unlawful
significantly deficient standard to decide what older human studies it could use.

26

SPA-030 (cols. 1-2), 041 (cols. 2-3). EPA adopted the Human Studies Review
Boards factual analysis of the dichlorvos human studys compliance with this
standard. SPA-030 (cols. 1-2), 041 (cols. 2-3). Like the Board, EPA found it could
rely on the study because the study was not significantly deficient compared to
ethical standards prevailing at the time the study was done. SPA-030 (cols. 1-2).
EPA then relied on this finding to use the study in evaluating the health risks of
exposure to dichlorvos. SPA-008 (col. 3) to 009 (cols. 1-3), 030 (col. 2).
EPA first used the human study data to derive a low effects dose, or starting
point, for its risk assessment. SPA-003 (col. 3), 009 (cols. 2-3); see also supra,
Statement of Facts I (discussing EPAs general approach to estimating and using
low effects doses). Next, and importantly, EPA decided that because its low effects
dose was based on data from human rather than animal studies, it could eliminate
its presumptive tenfold interspecies safety factor. SPA-009 (col. 2); see also supra,
Statement of Facts I (explaining EPAs general approach to applying safety
factors). EPA relied on this analysis to approve a set of food tolerances that
allowed continued sale of the pesticide under the Food Act. A-565 to 567, 596-97;
SPA-002 (cols. 1-2), 029 (col. 3), 041 (cols. 2-3); see also NRDC v. EPA, 658 F.3d
at 201.

27

VI. NRDC Brought Administrative and Legal Challenges to EPAs Use of
the Dichlorvos Human Study and Continued Approval of Dichlorvos

To protect against the dangers posed by dichlorvos, NRDC in 2006
petitioned EPA pursuant to the Food Act, 21 U.S.C. 346a(d). A-598. NRDCs
petition sought to prohibit any application of the chemical that results in unsafe
levels of human exposure, and requested that EPA revoke all food tolerances for
dichlorvos. Id. EPA denied the petition in 2007, after an eighteen-month delay. A-
695 (col. 1). To justify denying NRDCs petition and leaving the dichlorvos food
tolerances in place, EPA once again relied on data from the dichlorvos human
study. A-707 (cols. 2-3) to 708 (cols. 1-2).
NRDC challenged EPAs 2007 petition denial by filing administrative
objections under the Food Act. A-732; 21 U.S.C. 346a(g) (permitting the filing
of administrative objections). NRDC also requested an evidentiary hearing on
material factual issues concerning the adequacy of the dichlorvos human studys
consent procedure and the studys statistical validity. A-732; 21 U.S.C.
346a(g)(2) (authorizing a request for an evidentiary hearing). NRDC objected
that EPA had violated Section 201 by applying the Human Testing Rule to allow it
to use the study in spite of the studys ethical deficiencies. A-740 to 741
(incorporating legal argument from NRDCs challenge to Rule that standard

28

supplied by Rule materially deviated from National Academy of Sciences
Recommendation 5-7, contrary to Section 201). NRDC also objected to EPAs
failure to apply the full tenfold safety factor for the protection of children that
Congress established in its 1996 Food Act amendments. A-736.
EPA denied NRDCs objections and hearing request in a final order dated
July 23, 2008. SPA-021. NRDC petitioned for review of EPAs 2008 order in this
Court. NRDC v. EPA, 658 F.3d at 201. NRDC raised two issues in its first petition
for review in this Court. First, EPA was compelled to grant NRDC an evidentiary
hearing on genuine, material, and substantial factual issues concerning the
dichlorvos studys ethical and statistical validity. Id. at 219. Second, EPA failed to
provide a rational basis for waiving the childrens safety factor. Id. at 218. The
Court reached only this second issue and granted NRDCs petition on that issue,
holding that EPA failed to provide a lawful explanation for its departure from the
childrens safety factor. Id. Based on this holding, the Court vacated the 2008 order
in part and remanded to EPA for further proceedings. Id. at 218, 220. Because the
Courts vacatur and remand on the childrens safety issue encompassed those parts
of the 2008 order in which EPA relied upon the dichlorvos human study, the Court
found it unnecessary to resolve whether EPA had also arbitrarily rejected NRDCs
request for a hearing on the study. Id. at 219.

29

Following remand, EPA again denied NRDCs objections and hearing
request by final order dated September 5, 2012. SPA-001.
5
The 2012 order
preserves EPAs current regulatory approvals for dichlorvos and allows sales of the
pesticide to continue. See SPA-002 (cols. 1-3).
STANDING
NRDC and its members are harmed by EPAs 2012 order, and NRDC has
standing to challenge it. To establish standing, NRDC must show that its members
would have standing to sue in their own right, the interests it seeks to protect are
germane to its organizational purposes, and the litigation will not require its
members individual participation. Hunt v. Wash. State Apple Adver. Commn, 432
U.S. 333, 343 (1977).
NRDC satisfies this test. NRDCs members have standing to challenge
EPAs 2012 order because they suffer injury in fact that is both fairly traceable
to the challenged order and likely to be redressed by a favorable decision on the
issues presented in this petition for review. Friends of the Earth v. Laidlaw Envtl.
Servs., 528 U.S. 167, 180-81 (2000).

5
EPAs 2012 order renews its denial of NRDCs 2008 objections and
references and incorporates analysis from EPAs 2008 order. See SPA-002 (col. 2)
(EPA again denies NRDCs objections as to those portions of the July 23, 2008
order that were vacated.), SPA-004 (col. 1).

30

NRDCs members are injured by their risk of exposure to dichlorvos, a toxic
chemical that interferes with the nervous system and is linked to cancer. See supra,
Statement of Facts V. In denying NRDCs objections and hearing request in its
2012 order, EPA left in place tolerances that allow the widespread use of
dichlorvos to kill insects at agricultural sites; in food warehouses and processing
plants; in homes and businesses; and in outdoor areas including picnic grounds,
parking lots, and backyards. A-486, 517, 519, 549, 599; SPA-002.
NRDCs members are reasonably concerned about the health risks they and
their families face from exposure to dichlorvos in their homes and communities.
SPA-148 to 150 (Britton Decl. 3-6), 154-55 (Raymes Decl. 4-6). Because
dichlorvos may be encountered in a variety of public and private spaces, as well as
in residues in food and water, NRDC members cannot reliably know when they are
being exposed to the pesticide. A-486, 517, 519, 549; SPA-148 to 150 (Britton
Decl. 4-6), 154-55 (Raymes Decl. 4, 6). Even members who are aware of and
concerned about dichlorvoss health risks, and who have taken steps to try to
reduce dichlorvos exposure in more controlled settings like their homes, are
nevertheless unable to fully protect themselves and their families from exposure.
SPA-148 to 150 (Britton Decl. 4-7), 154-55 (Raymes Decl. 4-6).

31

The risk of health harm posed by dichlorvos is a credible threat of harm
sufficient to constitute an injury in fact. Baur v. Veneman, 352 F.3d 625, 633, 637
(2d Cir. 2003) (threatened harm in the form of an increased risk of future injury
may serve as injury-in-fact); see also Laidlaw Envtl. Servs., 528 U.S. at 185
(threat of future injury is a cognizable harm adequate to confer standing); N.Y.
Pub. Interest Grp. v. Whitman, 321 F.3d 316, 325-26 (2d Cir. 2003) (health risks of
exposure to potentially excessive air pollution levels are sufficient to establish
injury-in-fact).
NRDC members injuries are also fairly traceable to EPAs unlawful 2012
denial order, which left in place tolerances on dichlorvos that subject members to a
risk of harm by approving unsafe levels of exposure to dichlorvos. See supra,
Statement of Facts V.C & VI.
The risk of harm posed by EPAs 2012 order to NRDC members is likely to
be redressed by a decision vacating the order and prohibiting EPAs use of the
dichlorvos human study. EPA relied on the studys data in its assessment of the
risks of dichlorvos. SPA-162 to 164 (Sass Decl. 11-12); see also supra,
Statement of Facts V.C. In the absence of the study, the Food Act would require
EPA to reevaluate existing approvals for dichlorvos in order to identify a safe level
of exposure to humans. See 21 U.S.C. 346a(a)(1)(A), (b)(2)(A)(i); SPA-166

32

(Sass Decl. 18). If EPA relied on the best available data and applied appropriate
safety factors, without the human study, it is likely that some currently approved
uses of dichlorvos would be found unsafe, which would reduce total exposures and
associated health risks. See SPA-164 to 166 (Sass Decl. 13-16, 18); see also
SPA-150 (Britton Decl. 8-9), 155 (Raymes Decl. 7-8).
NRDCs standing to challenge EPAs denial of its evidentiary hearing
request is based on the procedural injury the organization has suffered while trying
to protect the underlying health interests of its members. The Food Act grants any
person the right to a public evidentiary hearing to determine material issues of fact
raised by a petition denial. 21 U.S.C. 346a(g)(2)(B). By arbitrarily denying
NRDCs hearing request, EPA has deprived NRDC of the opportunity to present
and examine evidence concerning the existence of informed consent for the
dichlorvos human study and the studys statistical validity before an administrative
law judge. This is a cognizable injury for standing purposes. Midwestern Gas
Transmission Co. v. Fed. Energy Regulatory Commn, 589 F.2d 603, 626 (D.C.
Cir. 1978) (party requesting an evidentiary hearing has standing to challenge
agency denial of that request); Gen. Motors Corp. v. Fed. Energy Regulatory
Commn, 656 F.2d 791, 795 n.9 (D.C. Cir. 1981) (same). It would be redressed by

33

a decision vacating EPAs 2012 order and directing the agency to conduct an
evidentiary hearing.
NRDCs interest in protecting the public from the harms posed by
dichlorvos is germane to its purpose. NRDC is an environmental and public health
organization with approximately 363,000 members nationwide. SPA-153 (Lopez
Decl. 4). One of NRDCs organizational priorities is reducing the load of
dangerous chemicals to which we are exposed. Id. (Lopez Decl. 5). Because
NRDC does not seek any individualized relief for its members, the participation of
individual members is not required. Hunt, 432 U.S. at 343. NRDC has standing to
sue.
SUMMARY OF ARGUMENT
This petition presents two arguments. First, EPA violated Section 201 by
using an ethically deficient human study to authorize continued use of dichlorvos.
In Section 201, Congress prohibited EPA from using studies exposing humans to
pesticides until EPA adopted a final rule regulating its use of such studies.
Congress said that rule shall be consistent with the principles proposed in the
2004 report of the National Academy of Sciences on intentional human dosing.
SPA-116. One of the Academys proposed principles requires EPA to reject human

34

studies, conducted before adoption of its rule, that clear and convincing evidence
shows were deficient relative to ethical standards prevailing at the time. A-167.
EPA conducted two internal ethics reviews of the dichlorvos human dosing
study at issue here. Each review identified numerous ethical deficiencies in the
study. See supra, Statement of Facts V.A & V.B. EPA nonetheless used and relied
on the study to authorize its current regulatory approvals of dichlorvos. It did so by
applying an unlawful reading of Section 201embodied in EPAs 2006 Human
Testing Rulethat requires it to reject only studies it finds are significantly
deficient relative to then-prevailing ethical standards. 40 C.F.R. 26.1704
(emphasis added). This violated Section 201. The Court should vacate EPAs 2012
order and prevent EPA from relying on the dichlorvos human study.
Second, it was arbitrary and capricious and contrary to the Food Act for
EPA to deny NRDCs request for an evidentiary hearing on disputed factual issues
material to EPAs use of the dichlorvos human study. The Food Act gives NRDC
the right to a hearing before an independent factfinder on material issues of fact
raised in objections to an EPA pesticide approval. The evidence NRDC submitted
with its objections establishes genuine, material, and substantial issues of fact
regarding both (1) the existence of informed consent for the dichlorvos study and
(2) the studys statistical reliability. This evidence included peer-reviewed analysis

35

by scientists and medical doctors, as well as EPA internal reviews that identified
defects in the studys consent procedure and statistical design. EPA nonetheless
arbitrarily denied NRDCs hearing request. This violated the Food Act and EPAs
regulations. The Court should vacate the denial and order a hearing.
6

ARGUMENT
I. Standard of Review

Judicial review is governed by the standards supplied in the Administrative
Procedure Act, 5 U.S.C. 706(2)(A). This Court must hold unlawful and set aside
EPAs 2012 order if it is arbitrary, capricious, an abuse of discretion, or otherwise
not in accordance with law. NRDC v. EPA, 658 F.3d at 215.
EPAs use of the dichlorvos human study is contrary to law if such use
violates the plain language of Section 201. See Waterkeeper Alliance v. EPA, 399
F.3d 486, 497, 504 (2d Cir. 2005).
EPAs denial of NRDCs request for an evidentiary hearing is reviewed
under the arbitrary and capricious standard, as well as the contrary to law standard.
Cf. Hynson, Westcott & Dunning, Inc. v. Richardson, 461 F.2d 215, 220 (4th Cir.

6
If this Court grants an order preventing EPA from using the dichlorvos human
study, then the Court need not reach NRDCs second argument challenging EPAs
arbitrary denial of an evidentiary hearing.

36

1972) (the APA does not permit[] an arbitrary denial of a hearing request where
there are genuine and substantial factual issues in dispute) (reviewing denial of
hearing request under Food Acts drug application provisions), affd as modified
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 622-23 (1973).
This Court must set aside EPAs decision if it relied on factors which Congress
has not intended it to consider, entirely failed to consider an important aspect of the
problem, offered an explanation for its decision that runs counter to the evidence
before the agency, or is so implausible that it could not be ascribed to a difference
in view or the product of agency expertise. Motor Vehicle Mfrs. Assn v. State
Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). EPA must examine the relevant
data and establish a rational connection between the facts found and the choice
made. Id. (internal quotation marks and citation omitted).
EPAs denial of a hearing request should be overturned if an examination
of the record discloses that material issues of fact are apparent to any reasonable
examiner. Cmty. Nutrition Inst. v. Young, 773 F.2d 1356, 1363 (D.C. Cir. 1985)
(discussing hearing request under Food Acts food additive provisions, 21 U.S.C.

37

348(f)(1)); see also 21 U.S.C. 346a(g)(2)(B) (Food Acts provision for
evidentiary hearings on material issues of fact raised by [pesticide] objections).
7

The inquiry articulated in Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837
(1984) controls EPAs interpretation of Section 201 and the Food Act. If Congress
unambiguously expressed its meaning in the statute, id. at 843, that meaning
controls. See Waterkeeper Alliance, 399 F.3d at 497.

II. EPAs Use of the Dichlorvos Human Study Violated Section 201

In Section 201, Congress directed EPA to suspend its use of intentional
human dosing studies until it adopted a rule governing use of such studies. Section
201 says that the rule shall be consistent with the principles proposed in the
National Academy of Sciences 2004 Report. SA-116 (Pub. L. No. 109-54, 201).
Under those principles, EPA cannot use human studies that predate its adoption of

7
In National Corn Growers Association v. EPA, the D.C. Circuit referred to the
standard of review for EPAs denial of a hearing request as necessarily
deferential. 613 F.3d 266, 271 (D.C. Cir. 2010). This Court should not read that
standard to be more deferential than arbitrary and capricious review. The
sufficiency of an evidentiary proffer is a legal question that courts can readily
evaluate; no heightened deference is warranted. See Weinberger, 412 U.S. at 622
(when reviewing an agency order denying an evidentiary hearing, a court of
appeals must determine whether the [agencys] findings accurately reflect the
record); United States v. FCC, 652 F.2d 72, 92 (D.C. Cir. 1980) (same). See also
Adams v. EPA, 38 F.3d 43, 55, 58 (1st Cir. 1994) (same); City of Wausau v. United
States, 703 F.2d 1042, 1044 (7th Cir. 1983) (applying arbitrary and capricious
standard to review agencys denial of rehearing request).

38

a human testing rule if clear and convincing evidence shows they are deficient
relative to ethical standards prevailing at the time of the study. A-167 (Report).
EPA twice reviewed the dichlorvos human study and found it deficient
relative to the ethical standards prevailing at the time the study was done. EPA
used the study anyway, in reliance on a provision of its Human Testing Rule that
purports to allow EPA to use studies conducted before the Rules adoption so long
as those studies are not significantly deficient relative to then-prevailing ethical
standards. 40 C.F.R. 26.1704 (emphasis added). EPAs interpretation of Section
201 to allow it to use the dichlorvos human study contravened both the statutes
plain language and its legislative history, which reflects Congresss desire to reign
in EPAs use of such studies.
A. EPAs Application of Its Significantly Deficient Test to Allow It
to Use the Dichlorvos Human Study Violated Section 201

EPAs use of the dichlorvos human study, based on the agencys application
of language in its Human Testing Rule, violated Section 201s unambiguous terms.
Section 201 prohibits EPA from accepting, considering, or relying upon studies
intentionally dosing humans with pesticides (through a ban on the use of funds for
such purpose) without a rule in place to govern the agencys consideration of such
studies. See SPA-116. It also imposes specific limitations on the substance of that

39

rule. Of chief importance here, Section 201 mandates that the rule shall be
consistent with the principles proposed in the 2004 report of the National Academy
of Sciences on intentional human dosing. Id.; Natl Assn of Home Builders v.
Defenders of Wildlife, 551 U.S. 644, 661 (2007) (Congresss use of shall
imposes mandatory obligations on EPA). One of the principles proposed in the
Report is Recommendation 5-7, which prescribes when it is appropriate for EPA to
use previously conducted dosing studies on humans. A-167. Recommendation 5-7
prohibits EPAs use of such older studies where there is clear and convincing
evidence that the studys conduct is deficient relative to ethical standards
prevailing at the time of the study. Id.
Despite Congresss command that any EPA rule for use of intentional
human dosing studies be consistent with the Academys proposed principles,
SPA-116, EPA materially modified Recommendation 5-7 in its 2006 Human
Testing Rule by inserting the qualifier significantly before the word deficient.
The Rule accordingly allows EPA to use and rely on a human dosing study
conducted before the Rules adoption unless clear and convincing evidence shows
that the studys conduct was significantly deficient relative to then-prevailing
ethical standards. 40 C.F.R. 26.1704 (emphasis added). EPA concedes that by
adding the word significantly, it modified and chang[ed] the Academys

40

proposed principle that EPA reject all deficient studies. A-337 (also explaining
that EPAs insertion of the qualifier significantly reflects EPAs viewnot the
Academysconcerning which ethically problematic studies should be rejected).
EPA relied on its modified significantly deficient test for older studies to
determine that it could use the dichlorvos human study to assess the risks of
dichlorvos. SPA-030 (col. 2) (2012 order) (discussing and adopting Human Studies
Review Boards finding, under the Human Testing Rule, that EPA could use the
study), SPA-041 (col. 2) (EPAs decision to rely on the study was made pursuant
to the Rule). EPA could not have used the study under the principle proposed in
Recommendation 5-7, as its own documented reviews of that study establish. Both
EPAs Pesticide Office and Human Studies Review Board found numerous ways
in which the study violated then-prevailing ethical standards set forth in the
Declaration of Helsinki. See generally supra, Statement of Facts V.A & V.B; A-
415 to 416 (Pesticide Office) (apparent ethical deficiencies relative to Helsinki
standards included inadequate medical monitoring of dosed subjects and failure to
verify whether the committee charged with reviewing study protocols was
independent from the studys sponsor and investigators), A-680 (Board) (consent
forms failed to fully meet the standards in the Helsinki Declaration). EPAs
Pesticide Office, which authored the initial review, observed that some of these

41

deficiencies suggest[] little consideration for the well-being of the subjects. A-
416 (discussing inadequate medical monitoring). The Board expressed similar
concerns, see A-679 to 682 (surveying problems with the studys medical
monitoring and informed consent protocols), but ultimately concluded that the
study did not reach the threshold of significantly deficient, and on that basis
offered its tepid endorsement. A-457.
EPA, by adopting the Boards reasoning, similarly based its decision to
approve use of the study on its view that the studys numerous ethical deficiencies
did not amount to significantly deficient conduct relative to then-prevailing
standards. SPA-030. Had EPAs consideration of the study been guided by the
Academys proposed principlewhich forbids use of all studies that are
deficient relative to applicable ethical standardsEPA would not have been able
to accept the study in light of the ethical faults it identified.
EPAs application of the significantly deficient standard, rather than the
deficient standard the National Academy proposed in its Report, thus
contravened Section 201s requirement that the standard be consistent with the
Reports proposed principles. SPA-116.
Section 201s legislative history underscores Congresss intent to prevent
EPA from using the dichlorvos human study and similar studies that were deficient

42

relative to ethical standards prevailing at the time. During debate on Section 201,
for example, Members repeatedly referenced certain human studies under EPA
review as examples of studies the agency should not use due to their gross
violation of ethical standards. SPA-141 (col. 2) (statement of Sen. Clinton).
8
The
dichlorvos human study was among the studies Members identified and
condemned for their ethical and scientific flaws.
9
Members also expressly
criticized EPAs proposed significantly deficient test on the grounds that it
would permit EPA to continue relying on old unethical studies.
10


8
See also SPA-138 (col. 1) (statement of Senator Boxer condemning human
dosing studies under review by EPA for violating international ethical standards
and Academy recommendations), SPA-141 (col. 2) (statement of Senator Clinton
denouncing studies that failed to obtain informed consent, inflicted harm on the
human subjects, . . . or failed to conduct long-term monitoring), SPA-143 (col. 3)
to 144 (col. 1) (statement of Senator Obama criticizing EPAs consideration of data
from studies that were not scientifically valid, failed to take the health
complaints of the subjects seriously, and failed to disclose the risk to the
subjects).
9
See supra, n.4 (full name of dichlorvos human study); A-326 to 327 (report
prepared for Senator Boxer and Representative Waxman that lists dichlorvos
human study among studies [EPA] is reviewing, or expects to review), A-310
n.89 and accompanying text (same, discussing dichlorvos study), A-316 n.120 and
accompanying text (same), A-320 to 321 notes 142, 149, & accompanying text
(same); SPA-132 (col. 3) (statement of Representative Solis referencing surveyed
studies), SPA-138 (col. 1) (statement of Sen. Boxer) (same).
10
A-284 to 285 (report prepared for Representatives Waxman and Solis and
Senator Boxer); SPA-133 (statement of Representative Solis discussing and
submitting report into Congressional record).

43

In other words, EPA has not only defied Congresss mandate in Section 201
by adopting a modified significantly deficient test for acceptance of older
studies. EPA has also applied that unlawful test to accept one of the very studies
Section 201s sponsors recognized as unethical and sought to prevent EPA from
using: the dichlorvos human study.
In sum, both Section 201s plain language and its legislative history show
that Congress intended for EPA to adopt a rule consistent with the principles
proposed by the National Academy. Such a rule would have bound EPA to reject
older studies that clear and convincing evidence shows are ethically deficient
relative to then-prevailing standards. EPA has reviewed the dichlorvos human
study and found it deficient. EPAs use of and reliance on the study in its 2012
order was accordingly contrary to law. The Court should vacate the 2012 order and
direct EPA not to use the study in its pesticide regulatory work. Cf. Alabama-
Tombigbee Rivers Coal. v. Dept of Interior, 26 F.3d 1103, 1105, 1107 (11th Cir.
1994) (affirming district court order barring federal agency from using scientific
report that was the product of a tainted procedure that violated federal law).

44

B. Section 201 Requires EPAs Rule on Use of Intentional Human
Dosing Studies to Be Consistent with the National Academy of
Sciences Recommendations

When Congress required EPA to make its human testing rule consistent
with principles proposed in the 2004 report of the National Academy of
Sciences, Congress was directing EPA to follow the Academys
Recommendations. SPA-116. Section 201s legislative history makes this clear.
See Chevron, 467 U.S. at 842-43 & n.9, 845 (legislative history analyzed at step
one to help determine Congresss intent).
The legislation that became Section 201 was introduced and passed in
response to Members concerns that EPAs draft rule would allow EPA to depart
from the Recommendations enumerated in the 2004 Report, including the
Recommendation that EPA reject ethically deficient older studies. See supra,
Statement of Facts III & Argument II.A. During floor debates, Members
emphasized that the legislation would require adherence to the
recommendations of the [National Academy of Sciences]. SPA-132 to 133 (quote
at 133) (statement of Representative Solis, the House co-sponsor), SPA-131 (col.
2) (statement of Rep. Dicks) (conference report reflects the will of both the House

45

and the Senate to stop such tests until the EPA develops regulations reflecting the
recommendation of the National Academy of Science[s]).
11

The Academys own use of the words proposals and principles in its
2004 Report supports this plain construction. The Reports executive summary
introduces and explicitly refers to its seventeen Recommendations as proposals.
A-043 ([T]o be specific about the proposals being made, the recommendations
follow.). The Report also uses the phrase scientific and ethical principles
described in earlier chapters interchangeably with the phrase substantive
recommendations offered in previous chapters. Compare A-083 (emphasis added)
with A-180 (emphasis added). For the Academy, like Congress, the 2004 Reports
Recommendations were the scientific and ethical principles the Academy
proposed in the Report.
Particularly in light of this history, the only plausible reading of Section 201
is that in stating principles proposed by the Academy, Congress meant the
Academys seventeen Recommendations. Because the traditional tools of

11
See also SPA-141 (cols. 1-2) (statement of Senator Clinton, the Senate co-
sponsor, observing that EPAs draft regulations are in direct contradiction to the
key recommendations made by the National Academy of Sciences), SPA-121
(cols. 1-2) (statement of Representative Solis criticizing EPAs expressed intention
to go against the recommendation of the [Academy]).

46

statutory construction, Chevron, 467 U.S. at 843 n.9legislative language and
historyprovide a clear sense that the phrase principles proposed in Section
201 refers to the Recommendations, Congresss clear purpose ends the inquiry at
Chevron step one. Gen. Dynamics Land Sys. v. Cline, 540 U.S. 581, 600 (2004).
III. EPA Unlawfully Denied NRDCs Request for an Evidentiary Hearing
on Material Factual Issues Concerning the Scientific Reliability of the
Dichlorvos Human Study and the Existence of Informed Consent

With its objections, NRDC requested an evidentiary hearing on material
factual issues concerning (1) whether the dichlorvos human study was conducted
without the informed consent of its subjects, and (2) whether the studys small
sample size made it scientifically unreliable. A-734, 743 to 746. EPA denied the
hearing request. SPA-021. NRDC identified specific and substantial evidence on
each issue that, if proven, would prevent EPA from relying on the dichlorvos
human study. This entitled NRDC to a hearing under the Food Act and EPAs
implementing regulations. See 21 U.S.C. 346a(g)(2)(B); 40 C.F.R. 178.32(b).
EPAs denial of NRDCs hearing request was arbitrary and capricious and violated
the Food Act and its implementing regulations. The Court should vacate the denial
and order a hearing. See Am. Cyanamid Co. v. FDA, 606 F.2d 1307, 1324 & n.166
(D.C. Cir. 1979) (agency ordered to conduct evidentiary hearing where requester
presented evidence raising an issue of fact).

47

A. The Food Act and EPAs Implementing Regulations Require EPA
to Conduct an Evidentiary Hearing to Resolve Genuine, Material,
and Substantial Issues of Fact

The Food Act permits any person to petition EPA to revoke pesticide
tolerances, and, if EPA denies the petition, to file administrative objections to the
denial and request an evidentiary hearing. 21 U.S.C. 346a(d), (g)(2)(A)-(B). The
Act says EPA shall . . . hold a public evidentiary hearing if and to the extent the
Administrator determines that such a public hearing is necessary to receive factual
evidence relevant to material issues of fact raised by the objections. Id.
346a(g)(2)(B). The Act and EPAs regulations provide for an administrative law
judge to preside over hearings for the purposes of authorizing discovery and
issuing subpoenas to compel testimony or documents, receiving evidence, and
resolving the disputed factual issues. See id.; 40 C.F.R. 179.60, 179.70, 179.85,
179.93, 179.105(a).
EPAs regulations provide that EPA must grant a request for an evidentiary
hearing if three conditions are met: (1) [t]here is a genuine and substantial issue of
fact, (2) [t]here is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues in favor of
the requestor, and (3) [r]esolution of the factual issue(s) in the manner sought by
the person requesting the hearing would be adequate to justify the action

48

requested. Id. 178.32(b). Once a hearing is granted, separate provisions govern
creation of the evidentiary record and the ultimate factual determination. Compare
40 C.F.R. Part 178, Subpart B (Procedures for Filing Objections and Requests for
Hearing) with 40 C.F.R. Part 179 (Formal Evidentiary Public Hearing).
As EPA has acknowledged, these regulations establish summary judgment-
type procedures that require a hearing to resolve disputed material factual
issues, analogous to the procedures in Federal Rule of Civil Procedure 56. SPA-
032 (cols. 1-2). EPA must therefore grant a public evidentiary hearing if a
requester raises any genuine issue of material fact in support of a pesticide
objection. See Fed. R. Civ. P. 56; Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
247-48 (1986). A hearing cannot be denied, much as summary judgment cannot be
granted, where reasonable minds could differ as to the import of the evidence.
Anderson, 477 U.S. at 250.
Like a party seeking to avoid summary judgment in district court, a party
requesting an evidentiary hearing need only submit evidence that establishes the
existence of a material factual dispute. See 21 U.S.C. 346a(g)(2)(B); 40 C.F.R.
178.32(b); OHara v. Natl Union Fire Ins. Co. of Pittsburgh, 642 F.3d 110, 117
(2d Cir. 2011). The requester need not make a fully persuasive case or submit all
of the evidence it would present at the evidentiary hearing. Citizens for Jazz on

49

WRVR, Inc. v. FCC, 775 F.2d 392, 397 (D.C. Cir. 1985) (Scalia, J.) (interpreting
the similar language of 47 U.S.C. 309(d)(2)). The requester must submit only
what a reasonable factfinder might view as a persuasive casethe quantum, in
other words, that would induce a trial judge to let a case go to the jury even though
he himself would (if nothing more were known) find against the plaintiff. Id. at
397 (emphasis in original). EPAs regulations confirm that, to get a hearing, a
requester need only show a reasonable possibility that a materially disputed issue
would be resolved in his favor; he need not conclusively resolve the dispute. 40
C.F.R. 178.32(b)(2). Once a hearing is granted, the law provides for fuller
development of the facts. 21 U.S.C. 346a(g)(2)(B); 40 C.F.R. 179.85, 179.93.
B. The Food Act Entitles NRDC to a Hearing to Determine Whether
the Dichlorvos Human Study Was Conducted Without the
Informed Consent of Its Subjects

With its objections, NRDC asked EPA for a hearing to determine whether
the dichlorvos human study had an adequate process for obtaining informed
consent from human subjects to be exposed to pesticides. A-734, 743-46. Informed
consent is an essential ethical requirement set forth in both EPAs regulations and
the Declaration of Helsinki, without which EPA cannot consider the study for
regulatory purposes. 40 C.F.R. 26.1704; A-014 to 015, 264 (col. 4). The
existence of informed consent is a question of fact. See Rainwater v. Alarcon, 268

50

F. Appx 531, 534 (9th Cir. 2008) (unpublished) (plaintiff presented sufficient
evidence to show that a question of fact exists as to whether he was provided with
information that allowed him to give informed consent to medical treatment);
DeNeui v. Wellman, No. Civ. 07-4172, 2009 WL 4847086, at *4 (D.S.D. Dec. 9,
2009) (unpublished) (whether a patient gave informed consent to undergo a
medical procedure is a material question of fact and therefore summary
judgment is inappropriate).
The following evidence identified by NRDC specifically establishes a
material and substantial factual issue as to the existence of informed consent:
1. A memorandum authored by EPAs Pesticide Office presenting an
initial review of the ethical deficiencies in the dichlorvos human study. A-413.
After identifying multiple problems with the informed consent procedure used,
EPA observed that the consent materials may well have misled subjects into
thinking they were participating in a drug trial rather than being dosed with a
harmful pesticide. A-415. As EPA described, the boilerplate consent form named
dichlorvos only in its title and referred to it as the drug without identifying it as a
pesticide. Id. The consent form did not tell participants that the study was
sponsored by a pesticide manufacturer. Id. Participants were told that the studys
purpose was the acquisition of medical knowledge and that its results might be

51

disclosed to regulatory authorities for medicines. Id. The consent materials
suggested that the risks of harm posed by the study were very unlikely to
materialize. Id. The materials told subjects that an antidote would be available to
counteract any harm. Id. The notes that accompanied the consent form did describe
dichlorvos as an insecticide, but they also referred repeatedly to drugs you will
be receiving or trial drugs. Id.
2. The Human Studies Review Board draft and final reports evaluating
the dichlorvos human study. A-458, 663, 734 (incorporating the Boards final
report, which was cited in EPAs petition denial, see A-729 (col. 2)), A-743. (The
draft report is substantively identical to the final report in all relevant respects.)
The Board found [i]t is clear that the written documentation for informed consent
failed to fully meet the standards of voluntary informed consent applicable at the
time the study was conducted, and concluded that the statements in the consent
forms are highly undesirable, and should not be used as part of modern-day
practice in writing such consent materials. A-472 to 473, 680-681, 743.
3. A published, peer-reviewed article by Dr. Alan Lockwood, a
neurologist. A-260 (Alan H. Lockwood, Human Testing of Pesticides: Ethical and
Scientific Considerations, 94 Am. J. Pub. Health 1908 (2004)), 243, 746. After
reviewing the dichlorvos human study and five other human dosing studies, Dr.

52

Lockwood stated that the dichlorvos study subjects were not informed that the
purpose of the study was to gather data for pesticide regulation. A-264 (col. 4). Dr.
Lockwood identified other [u]nacceptable deficiencies in the consent documents
for the dichlorvos study and other human dosing studies which raise serious
doubts as to whether the participants [sic] signatures were a reasonable reflection
of informed voluntary consent. Id. These deficiencies included failure to identify
the test compound as a pesticide, misleading statements about the effects, and
a failure to identify the source of funding. Id.
The evidence identified by NRDC that study subjects did not give their
informed consent creates a genuine, material, and substantial issue of disputed fact.
NRDCs submissions discuss serious deficiencies in the dichlorvos human studys
consent process that are both genuine and substantial, and the factual inferences to
be drawn as to the meaning of these defects are contested. See Chambers v. TRM
Copy Ctrs. Corp., 43 F.3d 29, 38 (2d Cir. 1994) (It is not the province of the
summary judgment court itself to decide what inferences should be drawn.).
NRDC presented the expert opinion of a medical doctor in a peer-reviewed article
that the informed consent procedure in the dichlorvos human study was
unacceptable and failed to obtain the informed consent of the study subjects. A-
260 (col. 1), 264 (col. 4). NRDC is now entitled to present evidence to a neutral

53

factfinder to attempt to establish that the misleading consent materials were
inadequate to obtain the voluntary and informed consent of the test subjects.
NRDCs submissions also show a reasonable possibility that an
administrative law judge would decide the contested issue in NRDCs favor. 40
C.F.R. 178.32(b)(2). Although the parties disagree about whether the subjects
gave their informed consent, A-414, 417, there can be no question that evidence
proffered by NRDC specifically identifies major problems with the consent
materials. EPAs own ethics reviewers faulted the materials for inaccurately
referring to dichlorvos as a drug and to the experiment as designed to acquire
medical knowledge and influence the regulation of medicines, which may
well have misled subjects about the nature of the study. A-415. EPAs internal
reviewers also identified further abuses of the consent process: downplaying the
studys risks, withholding key information about the availability of an antidote, and
omitting the name of the study sponsor. Id.
Many of the deficiencies EPA identified are also noted in the report of the
Human Studies Review Board and in the scientific article cited by NRDC. See A-
264 (opining the informed consent procedure was [u]nacceptable), 472-473, 681.
The Board said the consent materials were highly undesirable and should not be
used as part of modern-day practice. A-472 to 473, 680-81. NRDCs evidentiary

54

submissions are more than sufficient to establish a reasonable possibility that the
evidence would justify a determination that the study lacked informed consent. 40
C.F.R. 178.32(b)(2); cf. Anderson, 477 U.S. at 250 (summary judgment is
inappropriate if reasonable minds could differ as to the import of the evidence).
Finally, the existence of informed consent is determinative of the legality
of EPAs continued approval of dichlorvos. See 40 C.F.R. 178.32(b)(3). If the
dichlorvos human study was conducted without the informed consent of its
subjects, EPA cannot use it to set tolerances for dichlorvos. Id. 26.1704,
26.1701 (preventing EPA from relying on studies that failed to obtain informed
consent in actions under the Food Act and FIFRA); see also SPA-041 (cols. 2-3).
In a reevaluation of the pesticides safety under the Food Act, if EPA relied on
appropriate data from research on animals in lieu of the human study, EPA would
likely have to set more protective limits on dichlorvos. 21 U.S.C. 346a(a)(1)(A),
(b)(2)(A)(i); see supra, Statement of Facts I & V.C (tenfold interspecies safety
factor added when extrapolating from animal data).
In sum, NRDCs evidentiary submissions satisfy the Food Act and each
prong of the test supplied in 40 C.F.R. 178.32(b). NRDCs evidence shows that
the existence of informed consent in the dichlorvos human study is a disputed fact,
has a reasonable possibility of being resolved in NRDCs favor, and is material to

55

EPAs justification for maintaining dichlorvos approvals. The arbitrary and
unlawful denial of NRDCs request should be vacated and a hearing ordered.
C. NRDC Was Entitled to a Hearing to Determine Whether the
Dichlorvos Human Study Was Scientifically Unreliable

In its objections and request for an evidentiary hearing, NRDC presented
evidence that the dichlorvos human study was statistically invalid because six test
subjects do not constitute an adequate sample size from which to draw conclusions
about the general population. A-734, 743-45. Because of the small number of
subjects, NRDC objected that the studys design could not reliably determine
either (1) the full range of health harms from dichlorvos exposure or (2) the dose at
which such harms would occur. A-734, 743-45.
In support of this factual dispute, NRDC identified the following evidence:
1. The Human Studies Review Board draft and final reports evaluating
the dichlorvos human study. A-458, 663, 734 (incorporating the Boards final
report, which was cited in EPAs petition denial, see A-729 (col. 2)), A-743. The
Board noted that [t]he sample size was small and included only male subjects,
and concluded it was not clear whether the study was properly powered, given
that no sample size calculations seem to have been used in order to arrive at the
number of volunteers used. A-466, 674.

56

2. A memorandum authored by EPAs Pesticide Office that presented
the results of EPAs initial review of the ethical deficiencies in the dichlorvos
human study. A-413, 734, 745-46. EPA observed that the study protocol says
only that [t]he number of volunteers is based on the desire to gain adequate
information on the influence of dichlorvos on erythrocyte cholinesterase activity,
whilst exposing as few volunteers as possible to the study procedures. A-419.
3. A published, peer-reviewed article by Dr. Lockwood reviewing the
dichlorvos human study and five other human pesticide-dosing studies. A-260
(Alan H. Lockwood, Human Testing of Pesticides: Ethical and Scientific
Considerations, 94 Am. J. Pub. Health 1908 (2004)), 746. Dr. Lockwood
concluded that the dichlorvos human study had low statistical power and was
flawed and inconclusive. A-264 (col. 1), 266 (col. 4) to 267 (cols. 1-2)
(discussing the dichlorvos human study, listed at note 7, and other studies).
4. An article published in a scientific journal by Dr. Herbert Needleman,
a medical doctor with the University of Pittsburgh School of Medicine, and Dr.
Jennifer Sass, an NRDC biologist, that found the dichlorvos human study lacked
an adequate sample size to accurately measure harmful health effects. A-247 (col.
3) (Jennifer B. Sass & Herbert L. Needleman, Industry Testing of Toxic Pesticides
on Human Subjects Concluded No Effect, Despite the Evidence, 112 Envtl.

57

Health Perspectives A 150 (2004)), A-746. Drs. Needleman and Sass discussed the
dichlorvos human study and several other studies and observed that [a] study of a
handful of healthy adult subjects is inadequate to determine the expected response
to toxic chemical exposures from population diverse in ethnicity, life-stage, sex,
health status, genetic makeup, metabolism, and nutritional status. A-247 (col. 3).
The authors stated that such studies often lack enough subjects to provide
adequate statistical power to detect an effect if it is present. Id.
5. A letter published in a scientific journal from Drs. Needleman and
Sass responding to comments on the article cited above. A-258 (Jennifer B. Sass &
Herbert L Needleman, Letter, Human Testing: Sass and Needleman Respond to
Industry, 112 Envtl. Health Perspectives A 340 (2004)), 746. Drs. Needleman and
Sass found that in the dichlorvos human study and two others, sample sizes and
statistical power were too small to find an effect, if one were present. A-258 (col.
2). In support, the authors stated: The calculated statistical power to find an effect
was in the range of 0.2. This means that they had a one-in-five chance of detecting
an effect if it were present, practically guaranteeing a finding of no effect. Id. (col.
3). In other words, the study did not have enough subjects to reliably detect the full
range of exposure levels at which humans may suffer adverse effects.

58

6. A published essay by Dr. Lockwood about human pesticide dosing
studies in which the authors concluded that a human study with as few as six
subjects has too few subjects to be statistically valid. A-372 (col. 3) (Alan H.
Lockwood, The Ethical Bar Drops to Unacceptable, Envtl. Forum at 48
(Nov./Dec. 2005)), A-746.
7. Written comments Dr. Sass submitted to EPAs Human Studies
Review Board regarding the minimum sample size required for a human study to
produce a statistically significant result. A-423, 430, 746. Dr. Sass estimated that
[s]tudies with sample sizes < 50 had about a 3% chance of finding an effect if it
were present. A-430.
The evidence proffered by NRDC creates a genuine, material, and
substantial issue of fact that required EPA to hold an evidentiary hearing. 40
C.F.R. 178.32(b)(1). The adequacy of a studys sample size is a factual question.
Ratanasen v. Cal. Dept of Health Servs., 11 F.3d 1467, 1469 (9th Cir. 1993)
([W]hether the use of sampling and extrapolation is proper is a question of law,
while whether the sample size, etc., were appropriate is a question of fact.).
The scientific evidence that NRDC cited and submitted with its hearing
request was far more than necessary to show the existence of a material disputed
fact. EPAs own Human Studies Review Board found that the dichlorvos human

59

studys small sample size and lack of calculations on its statistical reliability raises
a substantial question of whether the study was scientifically reliable. A-674.
NRDC supplemented this evidence with published articles and letters three
scientists (two medical doctors and one Ph.D. biologist) who found that the
dichlorvos human study lacked an adequate sample size to identify either the toxic
effects from exposure or the dose at which those harmful effects occur. A-247 (col.
3), 258-59, 264 (col. 1), 266 (col. 4) to 267 (col. 1), 372, 430. Dr. Sasss written
comments to the Board, for example, elaborate on the conditions that must be
satisfied in any human study in order for it to adequately detect harmful effects,
and explain that a study with fewer than fifty subjects has only a three percent
chance of identifying a harmful effect. A-430. The dichlorvos study had just six
dosed subjects and three controls. A-414, 419.
This proffer more than satisfied NRDCs burden of identifying a genuine,
material, and substantial issue of fact under the first prong of EPAs hearing
regulations. See 40 C.F.R. 178.32(b)(1). Assuming the Court does not conclude
Section 201 bars EPA from using the dichlorvos human study, see supra,
Argument II, the factual question NRDC has raised concerning the studys
statistical validity would be best resolved in an evidentiary proceeding, through the
submission of testimony on the parties competing views concerning the studys

60

statistical power and reliability. See Cmty. Nutrition Inst., 773 F.2d at 1364 (a
material issue of disputed fact should be susceptible to a meaningful hearing);
Ratanasen, 11 F.3d at 1469, 1471-72 (describing hearing conducted to resolve
factual dispute concerning validity of statistical methods); cf. A-674 (Boards
acknowledgment of need for calculations to resolve whether studys sample size
was adequate).
Turning to the second prong of the regulations, the evidence NRDC
submitted also demonstrates there is a reasonable possibility that the statistical
issue will be decided in NRDCs favor. 40 C.F.R. 178.32(b)(2). NRDCs
objection that a study of only six male test subjects is statistically unreliable is
substantiated by analysis from scientists and doctors. Each of the experts discussed
above concludes that the study lacked an adequate sample size to reliably identify
the range of harms resulting from the study or the amount of the pesticide required
to cause those harms. A-258 to 259, 264 (col. 1), 267-68, 430, 746. These experts
considered opinions, several of them published and peer-reviewed, provide ample
grounds for a decision in NRDCs favor. Indeed, the only countervailing evidence
EPA cited in denying NRDCs hearing request was the report of the Human
Studies Review Boardwhich itself raised and did not fully dispel questions about
the studys statistical validity. SPA-021, 030 (cols. 1-2), 044 (cols. 1-3); A-674

61

(Boards observation that it was not clear whether the study was properly
powered).
It is true that the Board, in an analysis EPA adopted, ultimately gave EPA its
tepid endorsement of the study data for use in the dichlorvos risk assessment. A-
457. But EPA cannot deny a hearing request simply because it would prefer to
avoid further examination of a factual question it has chosen to call in its favor.
Hynson, 461 F.2d at 220 ([T]he applicant does not have to satisfy or convince the
[agency] by his evidence . . . as a predicate for securing his right to a hearing. If
that were his burden, a hearing would never be necessary or appropriate.); Pactra
Indus. v. Consumer Prod. Safety Commn, 555 F.2d 677, 684 (9th Cir. 1977) (an
agency cannot refuse a hearing merely because [it] has concluded that the
scientific evidence is adequate to support its order). At the very least, the Boards
analysis shows a reasonable possibility that the statistical question NRDC has
raised could be resolved in NRDCs favor after hearingwhich is all EPAs
hearing regulations require. 40 C.F.R. 178.32(b)(2); see Am. Cyanamid Co., 606
F.2d at 1318-19 (hearing required where responsible scientific experts differed in
their interpretations of a toxicity study). It is no surprise that EPA does not believe
its own factual conclusions about the dichlorvos human study should be reversed,
but the Food Act reserves that decision for a neutral factfinder. See 21 U.S.C.

62

346a(g)(2)(B); 40 C.F.R. 179.24, 179.60; Hynson, 461 F.2d at 220 (to require
a hearing requester to proffer enough evidence in support of his position to
convince the agency would render the hearing right purely illusory).
The statistical issue NRDC has raised is also determinative of the legality
of EPAs continued approval of dichlorvos, and thus satisfies the third and final
prong of EPAs hearing test. 40 C.F.R. 178.32(b)(3). It is arbitrary and unlawful
for EPA to use statistically invalid data to justify pesticide approvals. See Bellevue
Hosp. Ctr. v. Leavitt, 443 F.3d 163, 179 (2d Cir. 2006) (arbitrary for agency to
continue to rely on a limited set of data that had proved inadequate to allow
agency to fulfill certain statutory mandates); 40 C.F.R. 26.1701 (Human Testing
Rule applies to EPAs decisions whether to rely [in actions under the Food Act
and FIFRA] on scientifically valid and relevant data from intentional human
dosing studies (emphasis added)). Without the study, the Food Act would require
EPA to reevaluate existing approvals for dichlorvos in order to identify a safe level
of exposure to humans. See 21 U.S.C. 346a(a)(1)(A), (b)(2)(A)(i). The use of
more appropriate animal data would likely lead EPA to set more protective
tolerances for dichlorvos. See supra, Statement of Facts I & V.C (tenfold
interspecies safety factor added when extrapolating from animal data).

63

In sum, the evidence NRDC proffered with its hearing request was more
than sufficient to demonstrate a genuine, material, and substantial dispute of fact
regarding the statistical validity of the dichlorvos human study. 21 U.S.C.
346a(g)(2)(B); 40 C.F.R. 178.32(b)(1), (3). NRDC also established a
reasonable possibility that a neutral factfinder would resolve the dispute in its
favor. 40 C.F.R. 178.32(b)(2). Because NRDC met its legal burden to
demonstrate entitlement to an evidentiary hearing, EPAs denial of the hearing
request was arbitrary, capricious, and not in accordance with the Food Act or
EPAs own regulations. A hearing should be ordered.


64

CONCLUSION
For these reasons, this Court should vacate the 2012 denial order and forbid
EPA from using the dichlorvos human study. In the alternative, the Court should
direct EPA to conduct an evidentiary hearing.

Dated: December 20, 2012 Respectfully submitted,

s/ Nicholas Morales
Nicholas Morales
Natural Resources Defense Council
1152 15th Street, NW, Suite 300
Washington, D.C. 20005
nmorales@nrdc.org
Phone: (202) 717-8234
Fax: (202) 289-1060
Selena Kyle
Natural Resources Defense Council
111 Sutter Street, 20th Floor
San Francisco, CA 94104
skyle@nrdc.org
Phone: (415) 875-6100
Fax: (415) 875-6161

Counsel for Petitioner


65

CERTIFICATE OF COMPLIANCE
This brief complies with the type-volume limitation of Federal Rule of
Appellate Procedure 32(a)(7)(B) because it contains 13,974 words.
This brief complies with the typeface and type style requirements of Federal
Rules of Appellate Procedure 32(a)(5) and 32(a)(6) because it is written in a
proportionally spaced typeface in 14-point font.

s/ Nicholas Morales
Nicholas Morales




















SPECIAL APPENDIX


i
SPECIAL APPENDIX
Order Denying NRDCs Objections on Remand, 77 Fed. Reg.
54,402 (Sept. 5, 2012). ....................................................................... SPA-001
Order Denying NRDCs Objections and Requests for Hearing,
73 Fed. Reg. 42,683 (July 23, 2008). ................................................. SPA-021
7 U.S.C. 136. .............................................................................................. SPA-052
7 U.S.C. 136a. ............................................................................................ SPA-064
21 U.S.C. 342. ............................................................................................ SPA-085
21 U.S.C. 346a. .......................................................................................... SPA-089
Department of the Interior, Environment, and Related Agencies
Appropriations Act of 2006, Pub. L. No. 109-54 201,
119 Stat. 499. ...................................................................................... SPA-115
40 C.F.R. 26.1704. ..................................................................................... SPA-117
40 C.F.R. 178.32. ....................................................................................... SPA-118
151 Cong. Rec. H3670-3671 (May 19, 2005). ............................................. SPA-120
151 Cong. Rec. H6941-6943 (July 28, 2005). .............................................. SPA-122
151 Cong. Rec. H7013-7023 (July 28, 2005) ............................................... SPA-125
151 Cong. Rec. S7551-7561 (June 29, 2005) ............................................... SPA-136
NRDC, Petition for Review, No. 12-3671-ag (filed Sept. 17,
2012) ................................................................................................... SPA-147
Declaration of Jasanna Britton (Dec. 14, 2012)............................................ SPA-148
Declaration of Linda Lopez (Dec. 13, 2012) ................................................ SPA-152
Declaration of Joyce Kennedy Raymes (Dec. 11, 2012).............................. SPA-154
Declaration of Jennifer Sass, Ph.D (Dec. 19, 2012) ..................................... SPA-157
54402 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
86.110587 Emission standards for
which nonconformance penalties are
available.
* * * * *
(e) The values of COC
50
, COC
90
, and
MC
50
in paragraphs (a) and (b) of this
section are expressed in December 1984
dollars. The values of COC
50
, COC
90
,
and MC
50
in paragraphs (c) and (d) of
this section are expressed in December
1989 dollars. The values of COC
50
,
COC
90
, and MC
50
in paragraph (f) of this
section are expressed in December 1991
dollars. The values of COC
50
, COC
90
,
and MC
50
in paragraphs (g) and (h) of
this section are expressed in December
1994 dollars. The values of COC
50
,
COC
90
, and MC
50
in paragraph (i) of this
section are expressed in December 2001
dollars. The values of COC
50
, COC
90
,
and MC
50
in paragraph (j) of this section
are expressed in December 2011 dollars.
These values shall be adjusted for
inflation to dollars as of January of the
calendar year preceding the model year
in which the NCP is first available by
using the change in the overall
Consumer Price Index, and rounded to
the nearest whole dollar in accordance
with ASTM E2967 (reapproved 1980),
Standard Recommended Practice for
Indicating Which Places of Figures Are
To Be Considered Significant in
Specified Limiting Values. This method
was approved by the Director of the
Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. This
document is available from ASTM
International, 100 Barr Harbor Drive,
P.O. Box C700, West Conshohocken, PA
194282959, and is also available for
inspection as part of Docket A9106,
located at the U.S. EPA, Air and
Radiation Docket and Information
Center, 1301 Constitution Ave. NW.,
Room 3334, EPA West Building,
Washington, DC 20004, (202) 2021744
or at the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 2027416030,
or go to: http://www.archives.gov/
federal-register/cfr/ibr-locations.html.
This incorporation by reference was
approved by the Director of the Federal
Register on January 13, 1992. These
materials are incorporated as they exist
on the date of the approval and a notice
of any change in these materials will be
published in the Federal Register.
* * * * *
(j) Effective in the 2012 and later
model years, NCPs will be available for
the following emission standard:
(1) Diesel heavy-duty engine oxides of
nitrogen standard of 0.20 grams per
brake horsepower-hour in 86.007
11(a)(1)(i).
(i) [Reserved].
(ii) For heavy heavy-duty diesel
engines:
(A) The following values shall be used
to calculate an NCP in accordance with
86.111387(a):
(1) COC
50
: $3,219.
(2) COC
90
: $3,775.
(3) MC
50
: $10,729 per gram per brake
horsepower-hour NO
X
.
(4) F: 1.173.
(5) UL: 0.50 grams per brake
horsepower-hour NO
X
.
(B) The following factor shall be used
to calculate the engineering and
development component of the NCP for
the standard set forth in 86.007
11(a)(1)(i) in accordance with
86.111387(h): 0.005.
(2) Manufacturers may not generate
emission credits for any pollutant from
engines for which the manufacturer
pays an NCP for the NO
X
standard
identified in paragraph (j)(1) of this
section.
(3) The penalty shall be adjusted
annually as specified in 86.111387
with 2012 as the first year. Note that this
means AAF
2012
is equal to 1.
5. Section 86.111387 is amended by
revising paragraph (g)(1) to read as
follows:
86.111387 Calculation and payment of
penalty.
* * * * *
(g)(1) Except as provided in paragraph
(g)(2) of this section, the
nonconformance penalty or penalties
assessed under this subpart must be
paid as follows:
(i) By the quarterly due dates, i.e.,
within 30 days of the end of each
calendar quarter (March 31, June 30,
September 30 and December 31), or
according to such other payment
schedule as the Administrator may
approve pursuant to a manufacturers
request, for all nonconforming engines
or vehicles produced by a manufacturer
in accordance with paragraph (b) of this
section and distributed into commerce
for that quarter.
(ii) The penalty shall be payable to
U.S. Environmental Protection Agency,
NCP Fund, Motor Vehicle and Engine
Compliance Program, P.O. Box
979032St. Louis, MO 631979000. Note
on the check and supporting
information that this is an NCP
payment.
* * * * *
[FR Doc. 201221967 Filed 9412; 8:45 am]
BILLING CODE P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPAHQOPP20020302; FRL93599]
Dichlorvos (DDVP); Order Denying
NRDCs Objections on Remand
AGENCY: Environmental Protection
Agency (EPA)
ACTION: Final Order.
SUMMARY: In this order, EPA denies an
objection to a prior order denying a
petition requesting that EPA revoke all
pesticide tolerances for dichlorvos
under section 408(d) of the Federal
Food, Drug, and Cosmetic Act. The
objection was filed on February 1, 2008,
by the Natural Resources Defense
Council (NRDC). The original petition
was also filed by NRDC. Previously, in
July 2008, EPA denied this same
objection but the United States Court of
Appeals for the Second Circuit vacated
that decision, in part, and remanded the
matter to EPA. This order is being
issued in response to the courts
remand.
DATES: This order is effective September
5, 2012.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPAHQOPP20020302, is
available either electronically through
http://www.regulations.gov or in hard
copy at the OPP Docket in the
Environmental Protection Agency
Docket Center (EPA/DC), located in EPA
West, Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 204600001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 5661744, and
the telephone number for the OPP
Docket is (703) 3055805. Please review
the visitor instructions and additional
information about the docket available
at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Melanie Biscoe, Pesticide Re-evaluation
Division (7508P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 204600001; telephone
number: (703) 3057106; email address:
biscoe.melanie@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
In this document EPA denies an
objection by the Natural Resources
Defense Council (NRDC) concerning
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54403 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
EPAs denial of NRDCs petition to
revoke pesticide tolerances. This action
may also be of interest to agricultural
producers, food manufacturers, or
pesticide manufacturers. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
Crop production (North American
Industrial Classification System
(NAICS) code 111), e.g., agricultural
workers; greenhouse, nursery, and
floriculture workers; farmers.
Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPAs tolerance
regulations at 40 CFR part 180 through
the Government Printing Offices e-CFR
site at http://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
II. Introduction
A. What action is the agency taking?
In this order, EPA is issuing a revised
denial of an objection to an earlier EPA
order, (72 FR 68662, December 5, 2007),
denying a petition to revoke all
tolerances established for the pesticide
dichlorvos (DDVP) under the Federal
Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a. Both the objection as
well as the petition was filed with EPA
by NRDC. (Refs. 1 and 2). EPA had
previously denied this objection, (73 FR
42683, July 23, 2008), but that order was
vacated, in part, by the United States
Court of Appeals for the Second Circuit.
(NRDC v. US EPA, 658 F.3d 200 (2d Cir.
2011)).
NRDCs petition, filed on June 2,
2006, pursuant to FFDCA section
408(d)(1), asserted numerous grounds as
to why the dichlorvos tolerances
allegedly fail to meet the FFDCAs safety
standard. This petition was filed as EPA
was completing its reassessment of the
safety of the dichlorvos tolerances
pursuant to FFDCA section 408(q). (Ref.
3). In response to the petition, EPA
undertook an extensive review of its
dichlorvos safety evaluation in the
tolerance reassessment decision. Based
on this extensive review, EPA
concluded that dichlorvos met the
FFDCA safety standard and, therefore,
denied the petition. (72 FR 68695).
NRDC then filed objections with EPA to
the petition denial order and requested
a hearing on its objections. The
objections narrowed NRDCs claims to
two main assertionsthat, in assessing
the risk to dichlorvos, EPA unlawfully
reduced the statutory tenfold (10X)
additional safety factor for the
protection of infants and children and
EPA unlawfully relied on a human
toxicity study (the Gledhill study). After
carefully reviewing the objections and
hearing requests, EPA determined that
NRDCs hearing requests did not satisfy
the regulatory requirements for such
requests and that its substantive
objections were without merit. (73 FR
4270942711). NRDC sought review of
EPAs decision in the United States
Court of Appeal for the Second Circuit.
As noted, the Second Circuit court
vacated a portion of EPAs order finding
that [b]ecause EPA failed to explain
why it did not use a 10X childrens
safety factor for dichlorvos risk
assessments that relied on the Gledhill
study, EPA acted in an arbitrary and
capricious manner. (658 F.3d at 218).
Specifically, the court vacated those
portions of EPAs July 23, 2008 order
assessing the risk of dichlorvos based on
the Gledhill study * * * (Id.). The
court remanded the matter to EPA. (Id.
at 219).
On remand, EPA has carefully
examined the courts opinion and has
reconsidered that portion of its prior
decision that relied on the Gledhill
study in assessing dichlorvos risk.
Because the court found this portion of
EPAs order to be arbitrary and
capricious due to its absence of an
adequate explanation on the additional
safety factor for the protection of infants
and children, EPA focused on a
reexamination of what additional safety
factor for the protection of infants and
children should be applied for the
assessments based on the Gledhill
study. EPA concludes, like it did in the
July 23, 2008 order, that a threefold (3X)
additional safety factor will protect the
safety of infants and children.
Accordingly, EPA again denies NRDCs
objections as to those portions of the
July 23, 2008 order that were vacated.
Although EPA reaches the same
conclusion on remand on the additional
safety factor for the protection of infants
and children, EPA has provided a
revised, more extensive explanation for
its position. Because this revised
explanation addresses the courts reason
for finding portions of the July 23, 2008
order to be arbitrary and capricious,
EPA has not otherwise reopened or
reconsidered that prior order.
B. What is the agencys authority for
taking this action?
NRDC petitioned to revoke the
dichlorvos tolerances pursuant to the
petition procedures in FFDCA section
408(d)(1). (21 U.S.C. 346a(d)(1)). Under
section 408(d), EPA may respond to
such a petition by either issuing a final
or proposed rule modifying or revoking
the tolerances or issuing an order
denying the petition. (21 U.S.C.
346a(d)(4)). Here, EPA responded by
issuing an order under section
408(d)(4)(iii) denying the petition. (72
FR 68622, December 5, 2007).
Orders issued under section
408(d)(4)(iii) are subject to a statutorily-
created administrative review process.
(21 U.S.C. 346a(g)(2)). Any person may
file objections to a section 408(d)(4)(iii)
order with EPA and request a hearing on
those objections. (Id.). EPA is required
by section 408(g)(2)(C) to issue a final
order resolving the objections to the
section 408(d)(4)(iii) order. (21 U.S.C.
346a(g)(2)(C)). NRDC filed objections to
EPAs denial of its dichlorvos petition
and EPA issued a section 408(g)(2)(C)
order denying NRDCs objections. (73
FR 42683, July 23, 2008). EPAs order
denying NRDCs objections was vacated,
in part, and remanded to EPA. This
revised order on remand is also being
issued under section 408(g)(2)(C).
III. Statutory and Regulatory
Background
In this Unit, EPA provides
background on the relevant statutes and
regulations governing the matter on
remand as well as a much-abbreviated
discussion on pertinent Agency risk
assessment policies. A full discussion of
EPAs approach to pesticide risk
assessment is included in EPAs prior
order on NRDCs objections. (73 FR
4268542688). Because the courts
decision focused on the explanation
offered by EPA for its use of safety
factors, this Unit includes an expanded
discussion on use of safety or
uncertainty factors, including the
additional safety factor required by the
FQPA for the protection of infants and
children. Further, because Benchmark
Dose Methods analysis is discussed for
the first time in this revised order, a
short section explaining that concept is
included.
A. FFDCA/FIFRA and Applicable
Regulations
1. In general. EPA establishes
maximum residue limits, or
tolerances, for pesticide residues in
food and feed commodities under
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54404 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
section 408 of the FFDCA. (21 U.S.C.
346a). Without such a tolerance or an
exemption from the requirement of a
tolerance, a food containing a pesticide
residue is adulterated under section
402 of the FFDCA and may not be
legally moved in interstate commerce.
(21 U.S.C. 331, 342). Monitoring and
enforcement of pesticide tolerances are
carried out by the U.S. Food and Drug
Administration (FDA) and the U.S.
Department of Agriculture (USDA).
Section 408 was substantially rewritten
by the Food Quality Protection Act of
1996 (FQPA), which added the
provisions discussed below establishing
a detailed safety standard for pesticides,
additional protections for infants and
children, and the endocrine disrupting
substances screening program. (Pub. L.
104170, 110 Stat. 1489 (1996)).
EPA also regulates pesticides under
the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), (7 U.S.C. 136
et seq). While the FFDCA authorizes the
establishment of legal limits for
pesticide residues in food, FIFRA
requires the approval of pesticides prior
to their sale and distribution, (7 U.S.C.
136a(a)), and establishes a registration
regime for regulating the use of
pesticides. FIFRA regulates pesticide
use in conjunction with its registration
scheme by requiring EPA review and
approval of pesticide labels and
specifying that use of a pesticide
inconsistent with its label is a violation
of Federal law. (7 U.S.C. 136j(a)(2)(G)).
2. Safety standard for pesticide
tolerances. A pesticide tolerance may be
promulgated or left in effect by EPA
only if the tolerance is safe. (21 U.S.C.
346a(b)(2)(A)(i)). This standard applies
when responding both to petitions to
establish and petitions to revoke
tolerances. Safe is defined by the
statute to mean that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information. (21 U.S.C.
346a(b)(2)(A)(ii)).
Risks to infants and children are given
special consideration. Providing
additional protection to infants and
children was a particular focus of the
FQPA. Section 408(b)(2)(C) requires
EPA to make a specific determination
regarding the safety of tolerances to
infants and children and to consider,
among other things, information
concerning the special susceptibility of
infants and children to the pesticide
chemical residues * * *. (21 U.S.C.
346a(b)(2)(C)(i)(II) and (ii)(II)). This
provision also creates a presumptive
additional safety factor for the
protection of infants and children.
Specifically, it directs that [i]n the case
of threshold effects, * * * an additional
tenfold margin of safety for the pesticide
chemical residue and other sources of
exposure shall be applied for infants
and children to take into account
potential pre- and post-natal toxicity
and completeness of the data with
respect to exposure and toxicity to
infants and children. (21 U.S.C.
346a(b)(2)(C)). EPA is permitted to use
a different margin of safety for the
pesticide chemical residue only if, on
the basis of reliable data, such margin
will be safe for infants and children.
(Id.). For conveniences sake, the legal
requirements regarding the additional
safety margin for infants and children in
section 408(b)(2)(C) are referred to
throughout this Order as the FQPA
safety factor for the protection of infants
and children or simply the FQPA
safety factor.
3. Procedures for establishing,
amending, or revoking tolerances.
Tolerances are established, amended, or
revoked by rulemaking under the
unique procedural framework set forth
in the FFDCA. Generally, a tolerance
rulemaking is initiated by the party
seeking to establish, amend, or revoke a
tolerance by means of filing a petition
with EPA. (See 21 U.S.C. 346a(d)(1)).
EPA publishes in the Federal Register a
notice of the petition filing and requests
public comment. (21 U.S.C. 346a(d)(3)).
After reviewing the petition, and any
comments received on it, EPA may issue
a final rule establishing, amending, or
revoking the tolerance, issue a proposed
rule to do the same, or deny the
petition. (21 U.S.C. 346a(d)(4)).
Once EPA takes final action on the
petition by establishing, amending, or
revoking the tolerance or denying the
petition, any party may file objections
with EPA to EPAs decision on the
petition and seek an evidentiary hearing
on those objections. (21 U.S.C.
346a(g)(2)). Objections and hearing
requests must be filed within 60 days.
(Id.). The statute provides that EPA shall
hold a public evidentiary hearing if
and to the extent the Administrator
determines that such a public hearing is
necessary to receive factual evidence
relevant to material issues of fact raised
by the objections. (21 U.S.C.
346a(g)(2)(B)). EPA regulations make
clear that hearings will only be granted
where it is shown that there is a
genuine and substantial issue of fact,
the requestor has identified evidence
that would, if established, resolve one
or more of such issues in favor of the
requestor, and the issue is
determinative with regard to the relief
requested. (40 CFR 178.32(b)). Further,
a party may not raise issues in
objections unless they were part of the
petition and an objecting party must
state objections to the EPA decision and
not just repeat the allegations in its
petition. Corn Growers v. EPA, 613 F.2d
266 (D.C. Cir. 2010), cert. denied, 131 S.
Ct. 2931 (2011). EPAs final order on the
objections is subject to judicial review.
(21 U.S.C. 346a(h)(1)).
B. EPA Risk Assessment for
TolerancesPolicy and Practice
1. The safety determinationrisk
assessment. To assess risk of a pesticide
tolerance, EPA combines information on
pesticide toxicity with information
regarding the route, magnitude, and
duration of exposure to the pesticide.
The risk assessment process involves
four distinct steps: (1) Identification of
the toxicological hazards posed by a
pesticide; (2) determination of the level
of concern with respect to human
exposure to the pesticide; (3) estimation
of human exposure to the pesticide; and
(4) characterization of risk posed to
humans by the pesticide based on
comparison of human exposure to the
level of concern.
Toxicological hazards posed by a
pesticide are identified through use of
testing in laboratory animals or humans.
Generally, EPA will use the lowest no
observed adverse affect level (NOAEL)
or lowest observed adverse effect
level (LOAEL) from the available
studies or a calculated value called a
Benchmark Dose as a starting point
(called the Point of Departure) in
estimating the level of concern for
human exposure to the pesticide. Points
of Departure and levels of concern will
be identified for all exposure routes to
the pesticide (oral, dermal, and
inhalation) and durations of exposure
(acute, short-term, intermediate-term,
and chronic). Another critical aspect of
the level of concern determination
involves the use of safety or uncertainty
factors to compensate for the limitations
of toxicology testing. Safety and
uncertainty factors are discussed in
detail in Unit III.B.2. below. Having
identified a pesticides hazards, the
Point(s) of Departure, and level(s) of
concern, EPA then estimates exposure
to the pesticide taking into account the
various routes of exposure, how
exposures vary over time, and the
differences in exposure to different
subpopulations. Finally, EPA combines
information on hazard, level of concern,
and exposure to produce a
characterization of the risk posed by the
pesticide. Risks are calculated for all of
the various routes and durations of
exposure scenarios associated with a
pesticide. These risk assessment
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scenarios may be calculated separately
for different age-based population
groups (e.g., non-nursing infants) or
applied to all population groups,
including infants and children,
depending on information on the
potential for exposure and data on
differential sensitivity. A more
comprehensive discussion of this risk
assessment process is presented in
EPAs previous order denying
objections. (73 FR 4268542689).
Before turning to a detailed
discussion of safety and uncertainty
factors, EPAs risk characterization
process is briefly summarized because it
is frequently referred to in this order.
For pesticides that pose a risk over a
certain threshold of exposure, EPAs
characterization of risk is presented in
one of two ways: Either using the
Reference Dose (RfD) approach or the
Margin of Exposure (MOE) approach.
Importantly, these different approaches
do not render substantively different
results. Both approaches use the same
datathe Point of Departure, the
applicable safety/uncertainty factors,
and human exposure to the pesticide;
they just express the characterization of
risk in a different metric. Under the RfD
approach, EPA directly extrapolates a
dose from an animal or human study to
an overall safe dose for humans. An RfD
is calculated by dividing all applicable
safety/uncertainty factors into the level
of exposure from animal or human
studies determined appropriate for
assessing risk (i.e., the Point of
Departure). Estimated human exposure
to the pesticide is then compared to the
RfD to determine if it is excessive.
Under the Margin of Exposure (MOE)
approach, EPA does not calculate a safe
dose in humans but rather focuses on
the margin of exposure between a dose
from an animal or human study and
human exposure to the pesticide. A
MOE is calculated by dividing human
exposure to the pesticide into the Point
of Departure. To determine whether that
MOE is considered sufficiently
protective of humans, EPA compares it
to the product of all applicable safety/
uncertainty factors, referred to as the
target MOE. MOEs that are less than the
target MOE indicate a risk of concern.
At bottom, both approaches extrapolate
a safe measure of human exposure from
animal or human studies using a
mixture of uncertainty/safety factors.
2. Safety and uncertainty factors.
i. History. It has long been a standard
risk assessment practice to use
numerical factors in conjunction with
experimental toxicity data in assessing
risk to humans from exposure to
chemical substances. (Ref. 4). These
numerical factors are designed to
provide an additional margin of safety
so that risks to the populations covered
by an assessment are not understated.
The practice was first developed by the
Food and Drug Administration (FDA) in
the middle part of the last century. (Ref.
5). An influential 1954 paper by two
FDA scientists called for a hundredfold
margin of safety when extrapolating
from long-term animal experiments to
calculate safe doses in humans. (Ref. 6).
The paper justified this safety factor on
the basis of, among other things,
potential differences in sensitivity
between humans and laboratory animals
as well as potential variations in
sensitivity within humans. Accordingly,
the paper recognized that a smaller
factor would be appropriate where
adequate human data are available. An
explicit recommendation for a factor as
low as 10 was made by the Joint Food
and Agricultural Organization/World
Health Organization (FAO/WHO)
Meeting on Pesticide Residues in 1965
for circumstances where human data
was relied upon. (Ref. 7 at 12).
Eventually, it became common
regulatory practice to treat the
hundredfold margin of safety as
comprised of two tenfold factors: The
first addressing the potential difference
in sensitivity between humans and
experimental animals (i.e., interspecies
sensitivity) and the second addressing
variation within the human population
(i.e., intraspecies sensitivity). The
rationale for these two factors is
concisely summarized in a recent
publication from the International
Programme on Chemical Safety:
The interspecies uncertainty factor can be
considered to convert the NOAEL/NOAEC
[No observed adverse effect concentration]
for animals (derived from a small group of
relatively homogeneous test animals) into the
NOAEL/NOAEC anticipated for an average
representative healthy human. The
uncertainty factor for human variability
converts the NOAEL/NOAEC for the average
human into a NOAEL/NOAEC for susceptible
humans. Although adverse effect data in
humans can be used directly without the
need for an interspecies factor, the paucity of
such data means that the vast majority of risk
assessments are based on studies in
experimental animals.
(Ref. 8 at 15).
EPA, as well as other Federal and
international regulatory bodies, also
will, where appropriate, apply
additional numerical factors to take into
account chemical-specific
considerations affecting the risk
assessment. (Ref. 9) Use of these
additional factors is further explained in
Unit III.B.2.v., vi, and vii.
ii. Terminology. Different terminology
has been used to label numerical factors
used in calculating safe doses of
chemical substances. As noted, they
were first referred to as safety factors.
The terminology has evolved over the
decades, however, such that what was
once generally called a safety factor has
come to be generally referred to as an
uncertainty factor. (Ref. 10 at A3). The
rationale for the change was that,
although the use of such factors does
promote safety, there was a concern that
the use of the term safety implied that
these factors provided absolute safety.
(Ref. 11). The FQPA reintroduced the
term safety factors with its reference
to a margin of safety. 21 U.S.C.
346a(b)(2)(C). Subsequent to the passage
of FQPA, EPAs Office of Pesticide
Programs (OPP) has used the terms
safety factor and uncertainty factor
interchangeably. Both terms have been
criticized by the National Academy of
Sciences (NAS). The NAS explained
that the terms safety and uncertainty
imply that factors are simply added on
for safety or because of a lack of
knowledge or confidence in the
process. (Ref. 12 at 132). To the
contrary, according to the NAS, these
factors are scientifically-based and used
to adjust for differences in individual
human sensitivities, for humans
generally greater sensitivity than test
animals on a milligram-per-kilogram
basis, for the fact that chemicals
typically induce harm at lower doses
with longer exposures, and so on. (Id.).
iii. Scientific basis for inter- and
intraspecies factors. Only limited
scientific data, involving differing
sensitivity of humans and animals, are
cited in the 1954 article in justification
of the recommendation for a
hundredfold safety factor. Subsequent
investigations of both animal and
human toxicity data, however, have
provided general support for the
protectiveness of the tenfold factors for
interspecies and intraspecies sensitivity
differences if an adequate toxicity
database is available. (Refs. 9, 13, 14,
and 15). The interspecies factor has
been investigated through comparisons
of toxicity testing in laboratory animals
and humans. (Refs. 15 and 16). The
protectiveness of the human
intraspecies factor has been assessed
through examining sub-population
differences both among various human
age groups (the young, adults, and
elderly) as revealed in pharmaceutical
trials and between juvenile and adult
laboratory animals identified in toxicity
testing. (Ref. 13 at 211 (For substances
other than pharmaceuticals, age-related
differences in toxicity have been
primarily investigated in rodent
studies.); Ref. 17 at 462463
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(describing pharmaceutical trials
involving humans and comparative
studies in juvenile and adult laboratory
animals)). For example, the NAS, in its
report Pesticides in the Diets of Infants
and Children, looked to both human
data and animal data in evaluating the
potential for increased sensitivity in
infants and children to pesticides. (Ref.
18 at 344345).
iv. Adjustment of inter- and
intraspecies factors. In addition to
evaluating the protectiveness of the
intra- and interspecies uncertainty
factors, scientists have also examined
both generic biological as well as
chemical-specific factors that may affect
intra- and interspecies variability with
the aim of deriving more accurate
uncertainty factor values than the
default tenfold values.
One reason humans are considered to
be potentially more sensitive to toxic
agents than laboratory animals is that
otherwise equivalent external doses of
such agents for humans and animals on
a milligram-per-kilogram of body weight
basis may result in a greater internal
dose for humans. This is due to species
differences in general metabolic
processescommonly referred to as
toxicokineticsand is thought to be
related to species differences in
exchange surfaces and distribution
networks that constrain concentration
and flux of metabolic reactants. (Ref.
19 at 435; see Ref. 15 at 228).
In addition to toxicokinetic effects on
internal dose, differences between
humans and laboratory animals are also
driven by toxicodynamic factors.
Toxicodynamics refers to the manner in
which the target tissue and body
respond to the toxic agent. Thus,
interspecies differences are a factor of
both differences in the internal dose
received by humans and animals and
differences in how humans and animals
react to the internal dose received.
Similarly, sensitivity differences
between juveniles and adults, whether
humans or animals, are also considered
to be tied to toxicokinetic and
toxicodynamic factors. Accordingly,
both the inter- and intraspecies
uncertainty factors are considered to
have toxicokinetic and toxicodynamic
components. EPA typically has
considered both the tenfold (10X) inter-
and intraspecies factors to be roughly
equally divided on a logarithmic basis
(i.e., 10
0.5
or roughly a 3X factor)
between toxicokinetics and
toxicodynamics. (Ref. 19 at 429; see
also Ref. 19 at 440 (explaining why two
3X factors [technically, 3.16X] would be
equivalent to a 10X factor)). Other
organizations have recommended that,
while toxicokinetics and
toxicodynamics play an equal role in
intra-human variability, toxicokinetics
has a greater effect on interspecies
differences and thus recommend that
the tenfold interspecies factor be
divided into a fourfold factor for
toxicokinetics and 2.5-fold factor for
toxicodynamics. (Ref. 8 at 17; see Ref.
14).
Of the toxicokinetic and
toxicodynamic differences between
humans and animals and among various
human subgroups, the most is known
about the toxicokinetic differences
between humans and animals. For
inhalation exposures, EPA has used
toxicokinetic information on humans
and animals to create generic dosimetric
adjustment factors that replace that
portion of the interspecies factor tied to
toxicokinetic differences. (Refs. 19 at 4
29; 20). Where such dosimetric
adjustment factor is used, the
interspecies factor is reduced to 3X.
EPA guidance entitled A Review of
the Reference Dose and Reference
Concentration Processes (RfD
Guidance) also urges that data be
developed to support substitution of
chemical-specific adjustment factors
(sometimes referred to as data-derived
factors) for the default 10X uncertainty
factors for inter- and intraspecies
variability. (Ref. 19 at xviii xix, 447).
This guidance recognizes that chemical-
specific data from both humans and
animals has been relied upon by EPA to
adjust the human intraspecies
uncertainty factor citing an article by
Dourson et al. That article collects
instances in which EPA has adjusted
uncertainty factors on a chemical-
specific basis. (Ref. 9). For example,
Dourson et al. point to a 1996 EPA
assessment of Aroclor that reduced the
human intraspecies factor to 3X given
that the Point of Departure came from a
sensitive animal populationthere,
infant rhesus monkeys. In discussing
the Dourson et al. article, the RfD
Guidance notes that:
In those cases where developmental effects
were the most sensitive endpoint (0 RfCs, 6
RfDs), reduction of the intraspecies
[uncertainty factor] from 10 to 3 was based
on data derived either from human data
showing which age groups or time periods
were most susceptible (e.g., methyl mercury
exposure to the developing fetus) or from an
animal study with support from strong
human or other data (e.g., Aroclor 1016 in
utero exposure in monkeys, strontium-
induced rachitic bones in young rats).
(Ref. 19 at 443). The RfD Guidance
endorsed a view similar to that
expressed in an agency-wide paper
prepared in development of EPAs
Childrens Safety Factor Policy. That
paper also noted that there were
circumstances where data from human
studies or from animal studies might
support reduction of the human
intraspecies uncertainty factor: The
Toxicology Working Group recommends
that reduction of the intraspecies
uncertainty factor from a default of 10
be considered only if data are complete
and the age group or window of
vulnerability during development has
been clearly delineated, preferably
based on human data or on animal data
with supporting human data. (Ref. 21
at 28). On the other hand, the RfD
guidance also recognized that a 10X
intraspecies factor may sometimes be
too small because of factors that can
influence large differences in
susceptibility, such as genetic
polymorphisms. (Ref. 19 at 444).
In sum, the 10X inter- and
intraspecies factors are default values.
Although there is substantial scientific
support for these default values,
chemical-specific human and animal
data may be relied upon in reducing,
confirming, or increasing these default
values.
v. Additional Safety/Uncertainty
Factors. In addition to the inter- and
intraspecies factors, risk assessors from
EPA as well as other Federal and
international regulatory agencies also
apply additional or modifying
safety/uncertainty factors based on
specific circumstances related to the
toxicity data, particularly with regard to
deficiencies in that data. Like the inter-
and intra-species factors, these
additional factors help to ensure that
risks to populations covered by an
assessment are not understated.
Additional factors are applied to
address: (1) An absence of critical
toxicity data; (2) the failure of a study
to identify a NOAEL; (3) the necessity
of using sub-chronic data to choose a
Point of Departure for estimating
chronic risk; and (4) results in a study
that suggest the inter- or intraspecies
factors may not be sufficient (sometimes
referred to as a modifying factor).
(Ref. 10 at 9). Generally, a safety factor
value of 10X or 3X (which is considered
to be one-half of 10X on the logarithmic
scale) is used to address these concerns.
The protectiveness of these default
values has also been the subject of
scientific examination. Studies have
been done on the variations in the levels
of NOAELs in the databases for various
pesticides. They confirm the need for an
additional factor when core data are
lacking. (Ref. 22). Examination of the
completeness of the animal database
remains important even when human
data are used as the Point of Departure
for calculating the RfD. The latest EPA
guidance on RfDs emphasizes that in
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these circumstances [i]nformation on
life stages and organ systems may come
from either animal or human studies.
(Ref. 19 at 445). The guidance notes
that the lack of a two-generation
animal reproduction study might be
considered a deficiency even if the
reference value is based on human
data. (Id.). Similarly, research has been
conducted on existing databases to
determine the adequacy of uncertainty
factors used to address reliance on a
LOAEL instead of a NOAEL, or
subchronic data to estimate chronic risk.
(Refs. 9 and 15).
Selection of particular values for these
additional uncertainty values depends
on what is known from the full body of
information about the chemical,
including both data from testing with
animals and humans, about the
chemical. For example, as EPAs RfD
Guidance advises: the size of the
database factor to be applied will
depend on other information in the
database and on how much impact the
missing data may have on determining
the toxicity of a chemical and,
consequently, the POD [Point of
Departure]. (Ref. 19 at 445). With
regard to an additional factor for
extrapolation of a NOAEL from a
LOAEL, Dourson et al. report that
[a]nalysis of several data bases suggest
that a factor of 10 or lower is adequate
and that use of data does support a
lower factor with certain chemicals.
(Ref. 9 at 112). The critical
consideration, according to Dourson et
al., is the severity of the effect at the
LOAEL: The data indicate that when
faced with a LOAEL and not a NOAEL,
the choice of uncertainty factor should
generally depend on the severity of the
effect at the LOAEL. (Id.). Specifically,
Dourson et al. note that [l]ess severe
effects would not require a large factor,
because, presumably, the LOAEL is
closer to the unknown NOAEL. (Id.).
vi. FQPA safety factorintegration
with traditional uncertainty factors.
EPAs safety/uncertainty factor practice
with regard to pesticides was altered to
a degree by the Food Quality Protection
Act (FQPA). (Ref. 10). That Act
established a presumptive additional
safety factor of 10X to protect infants
and children. The additional factor was
designed to account for the
completeness of the toxicity and
exposure databases and the potential for
pre- and post-natal toxicity. EPA has
interpreted this legislation as both a
codification and expansion of prior
EPA practice with regard to additional
safety/uncertainty factors. (Ref. 10 at A
3A5). It codified EPAs prior practice
by requiring the additional presumptive
factor to address toxicity data
completeness issues (i.e., absence of a
particular study, lack of a NOAEL in a
completed study, or absence of chronic
data). These traditional additional
uncertainty factors became FQPA safety
factors for the protection of infants and
children. This accords greater protection
to infants and children because for
FQPA safety factors, unlike pre-FQPA
additional factors, there is a
presumption, which can only be
overcome by reliable data, that they will
be applied. At the same time, EPA
concluded that Congress had not
intended EPA to double-up on safety
factors by, for example, applying an
additional uncertainty factor due to
missing data, and applying an FQPA
additional safety factor as well to
address the same missing data. (Ref. 10
at A4). Congress expanded EPAs prior
practice by providing that the additional
FQPA safety factor for the protection of
infants and children was designed to
address not just toxicity data
deficiencies but exposure data
deficiencies as well and by its emphasis
on protecting against potential pre- and
post-natal toxicity. In theory, EPA could
have, prior to the enactment of the
FQPA, used an additional or
modifying factor to address health
risks to children not otherwise protected
by the interspecies, intraspecies, or data
deficiency safety factors, but use of such
a factor was not common. The FQPA
also modified the status quo by making
the additional safety factor for infants
and children presumptive in nature.
The narrowly-focused and highly-
prescriptive nature of the FQPA safety
factor provision has required careful
integration with pesticide risk
assessment approaches under other
statutes and, more generally, with
Agency risk assessment practices. As
noted above, the FQPA, with regard to
the assessment of risks to infants and
children, essentially codified EPAs
prior risk assessment practice as to
additional uncertainty factors and it
expanded the use of additional
uncertainty factors into new areas. The
FQPA, however, did not speak to use of
traditional (non-additional) uncertainty
factors (i.e., the inter- and intraspecies
factors). Thus, the end result was that
some uncertainty factors for FFDCA
pesticides remained unaffected by the
new statutory requirements (the inter-
and intraspecies factors), some
uncertainty factors became FQPA safety
factors (additional uncertainty factors
that addressed toxicity data
deficiencies), and some safety factors
that either had previously never existed
or were at least extremely rare were
created as a statutory phenomenon (a
factor to address exposure data base
deficiencies and a factor to address
potential pre- and post-natal toxicity).
This selective inter-weaving of statutory
requirements with Agency science
policy made FFDCA risk assessments
for pesticides unique compared to
general Agency risk assessment practice.
Pesticide risk, however, is not
regulated under a single statute. Risks to
workers or the environment from
pesticide use are regulated by EPA
under FIFRA, not the FFDCA. Further,
EPA may address risks posed by
pesticide contamination of the
environment under several other
statutes, including the Safe Drinking
Water Act, 42 U.S.C. 300f et seq., the
Resource Conservation and Recovery
Act, 42 U.S.C. 6901 et seq., and the
Comprehensive Environmental
Response, Compensation, and Liability
Act, 42 U.S.C. 9601 et seq. Prior to
enactment of the FQPAs specific
provisions on pesticide risk assessment,
a pesticide risk assessment performed
by EPAs Office of Pesticide Programs
under the aegis of FFDCA section 408
could generally be easily translated for
use by the Office of Pesticide Programs
under FIFRA, or by the other media
offices within EPA for use under other
statutes. However, once pesticide risk
assessment under the FQPA became not
simply a matter of good scientific
practice but was channeled by explicit
statutory requirements, it became
incumbent upon the Office of Pesticide
Programs to prepare its FFDCA
pesticide risk assessments in a manner
that clearly delineated what aspects of
the assessment were driven solely by
science and what aspects primarily by
FQPA statutory requirements.
Specifically, the Office of Pesticide
Programs had to be transparent with
regard to whether it was relying on
FQPA safety factors based on unique
FQPA requirements (exposure database
deficiencies and potential pre- and post-
natal toxicity) or FQPA safety factors
that are essentially a codification of
prior general EPA additional safety/
uncertainty factor practice.
EPA addressed these transparency
issues at length in its 2002 policy
statement on the FQPA safety factor. To
clarify how the FQPA safety factor
provision left a portion of prior safety/
uncertainty practice unchanged,
codified another portion, and also
expanded the use of safety factors, EPA
explained the overlap between the
FQPA safety factor and additional safety
factors in depth and included the
following figure to graphically illustrate
the issue:
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With regard to providing transparency
on the FQPA safety factor decisions,
EPA took two steps. First, it adopted a
new term, the special FQPA safety
factor, for children safety factors that
were based solely on the new FQPA
requirements. Second, it adopted the
approach of calculating two different
safe doses for a pesticide: one that
excluded any special FQPA safety
factors and one that included them. The
former was referred to, in line with
standard EPA policy, as a Reference
Dose (RfD), and the latter as a
Population Adjusted Dose (PAD).
Introducing the new terminology on
FQPA safety factors into long-
established safety factor practice has
proved challenging. EPA staff on
occasion drafted documents that (1)
claimed no FQPA safety factor was
needed but applied an additional
uncertainty factor to address the
completeness of the toxicity data base or
reliance on a LOAEL; or (2) treated the
special FQPA safety factor as the only
type of FQPA safety factor. However, as
EPAs policy made clear, EPA
interpreted FFDCA section 408(b)(2)(C)
as codifying prior practice as to
additional uncertainty factors such that
these factors became FQPA factors. The
mislabeling of uncertainty factors did
not substantively change risk
assessment outcomes but it did raise the
confusion level on an already complex
topic. Eventually, EPA determined that
the term special FQPA safety factor
caused more problems than it solved
and abandoned it. However, EPA has
retained the approach of continuing to
calculate both a safe dose with, and
without, what was once referred to as
special FQPA safety factors.
vii. FQPA safety factordecision-
making guidance. In 2002, EPA issued
detailed policy guidance for Agency risk
assessors on decision-making under the
FQPA safety factor provision. The
purpose of this guidance was concisely
set forth by EPA: [T]his guidance
explains how OPP intends to take
intoaccount * * * potential pre- and
post-natal toxicity and completeness of
the data with respect to exposure and
toxicity to infants and children as
directed by FFDCA section
408(b)(2)(C)(i). (Ref. 10 at ii).
Although the guidance is structured
around these statutory considerations,
EPA also emphasizes throughout that
the FQPA safety factor decision is a
weight-of-the-evidence decision that
must consider all available data. Thus,
the policy specifies that [b]efore any
decisions are made on the appropriate
FQPA safety factor applied to ensure the
safety of infants and children from the
use of a particular pesticide, all of the
relevant submitted data for the pesticide
should be assembled and reviewed by
Agency scientists. (Id. at 8).
This emphasis on the broadness of the
inquiry is repeated in the discussion of
the statutory consideration related to the
completeness of the toxicity database.
According to EPA, this consideration
should not be narrowly focused on
EPAs existing database requirements.
Rather, the completeness inquiry
should be a broad one that takes into
account all data deficiencies. (Ref. 10
at 23). At the same time, the guidance
stresses that a determination of the
possible need for and size of the
database uncertainty factor will
necessarily involve an assessment that
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considers the overall weight-of-evidence
to evaluate the significance of the data
deficiency. (Id. at 26).
With regard to potential pre- and post-
natal toxicity, the policy emphasizes
that evaluation of this consideration
cannot be divorced from the existing
process for choosing levels of concern
(i.e., RfDs, PADs, and target MOEs).
Thus, EPA instructs risk assessors to
evaluate the concern with data showing
pre- and post-natal toxicity by
considering, among other things, the
degree to which protection for infants
and children is provided by the
standard approach for deriving RfDs
through the application of traditional
uncertainty factors. (Id. at 29). The
guidance stresses that [i]n particular,
the risk assessor should consider the
protection accorded infants and
children by the intraspecies uncertainty
factor. (Id.). EPA notes that the
scientific literature as well as the
National Academy of Sciences has
concluded that the intraspecies factor is
generally adequate to protect infants
and children; however, the policy
points out that certain chemicals may
display greater than 10X age-related
variability. For this reason, EPA
reiterates that [t]he adequacy of the
standard intraspecies factor to address
the potential for greater sensitivity or
susceptibility of children should be
considered in the context of evidence on
potential pre- and post-natal toxicity as
discussed below. (Id.; see also Id. at
5152). The policy paper went on to
provide numerous examples of weight-
of-the-evidence considerations relevant
to evaluation of human and animal data
on pre- and post-natal toxicity. (Id. at
3033).
The discussion on the completeness
of the exposure database focuses on
whether the various approaches EPA
uses to assess exposure are likely to
understate it. Risk assessors are to
evaluate whether their assessments
have addressed all significant exposure
routes and whether there may be
uncertainty about whether OPPs
approach to estimating exposure for a
particular use pattern, pathway, or
aggregate exposure is sufficiently health
protective. (Id. at 48).
3. Benchmark dose approach. As
indicated above, EPA has traditionally
used a NOAEL or LOAEL as a Point of
Departure in estimating an exposure
level of concern for a pesticide or other
substance. Increasingly, however, EPA
uses a more sophisticated modeling tool
known as the Benchmark Dose approach
as an alternative to using NOAELs or
LOAELs for Point of Departure
selection. (Refs. 23). A benchmark dose,
or BMD, is a point estimate along a
dose-response curve that corresponds to
a specific response level. For example,
a BMD
10
represents a 10% change from
the background level (the background
level is typically derived from the
control group). In addition to a BMD, a
confidence limit may also be calculated.
Confidence limits express the
uncertainty in a BMD that may be due
to sampling and/or experimental error.
The lower confidence limit on the BMD
is termed the benchmark dose limit
(BMDL). Use of a BMD or BMDL for
deriving the Point of Departure allows
more precise estimates of the Point of
Departure, resulting in tighter
confidence intervals. Use of the BMDL
also helps ensure with high confidence
(e.g., 95% confidence) that the selected
percentage of change from background
is not exceeded. Numerous scientific
peer review panels over the last decade
have supported the Agencys
application of the BMD approach as a
scientifically supportable method for
deriving Point of Departures in human
health risk assessment, and as an
improvement over the historically
applied approach of using NOAELs or
LOAELs. (Refs. 24, 25, and 26). The
NOAEL/LOAEL approach can look at
the dose response at only the few doses
used in a study, and is therefore limited
by the characteristics of the study
design, such as dose selection, dose
spacing, and sample size. (Ref. 23 at 3
5). With the BMD approach, all the dose
response data are used to derive a dose
response curve. For all of these reasons,
BMD analysis is preferred by EPA to the
NOAEL/LOAEL approach of selecting a
Point of Departure from studies when
the available data are amenable to BMD
modeling consistent with the biological
processes relevant to the study in
question.
IV. Dichlorvos
Dichlorvos is a chlorinated
organophosphate pesticide that inhibits
plasma, red blood cell (RBC), and brain
cholinesterase in a variety of species.
(Ref. 3 at 122123). Cholinesterase
inhibition is a disruption of the normal
process in the body by which the
nervous system chemically
communicates with muscles and glands.
Although cholinesterase inhibition in
the nervous system is not itself regarded
as a direct adverse effect, it is generally
accepted as a key component of the
mechanism of toxicity leading to
adverse cholinergic effects. (Ref. 27 at
25; see 73 FR 4268842689). Inhibition
of blood cholinesterase is not an
adverse effect, but may indicate a
potential for adverse effects on the
nervous system and thus serves as a
surrogate for cholinesterase inhibition
in the nervous system (Ref. 27 at 28).
Subchronic and chronic oral dichlorvos
exposures to rats and dogs as well as
chronic inhalation dichlorvos exposure
to rats resulted in significant decreases
in plasma, RBC, and/or brain
cholinesterase activity. Repeated, oral
subchronic dichlorvos exposures in
male humans were associated with
statistically and biologically significant
decreases in RBC cholinesterase
inhibition. These cholinesterase effects
occurred at dose levels below levels at
which any other adverse effect was
seen. Generally, there was no evidence
of increased sensitivity to young
animals following exposure to
dichlorvos. No evidence of increased
sensitivity to young animals was seen
following in utero dichlorvos exposure
to rat and rabbit fetuses as well as pre/
post natal dichlorvos exposure to rats in
developmental, reproduction, and
comparative cholinesterase studies. The
only evidence of sensitivity in the
young was seen in one parameter,
auditory startle amplitude, in a
developmental neurotoxicity study;
however, the effects in the rat pups in
that study were at levels well above
levels that result in RBC cholinesterase
inhibition.
Because inhibition of cholinesterase
activity was identified as the most
sensitive effect, it was selected as the
toxicity endpoint for assessment of risks
for all acute and chronic dietary
exposures, as well as short-,
intermediate-, and long-term (chronic)
dermal, inhalation, and incidental oral
residential exposures. For each risk
assessment scenario, EPA selected a
Point of Departure based on either an
animal or human study taking into
account the duration of the study and
the route of exposure used in the study.
(Ref. 3 at 130135). These Points of
Departure were used in calculating RfD/
PADs and acceptable MOEs. Due to the
lack of sensitivity differences between
adults and juveniles, the resulting RfD/
PADs and acceptable MOEs were
designated as applicable to all
population subgroups, including infants
and children. Animal studies were used
in choosing levels of concern for
evaluating risk from acute and chronic
dietary exposure; acute dermal
exposure; and acute and chronic
inhalation exposure. A human study
(the Gledhill study) was used in
evaluating risk from short-term
incidental oral exposure; short-,
intermediate-, and long-term dermal
exposure; and short- and intermediate-
term inhalation exposure. All of the
studies from which a Point of Departure
was selected were conducted in adults
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(adult humans or adult animals). (See
Table 1).
Safety factor determinations used in
determining the level of concern for
each risk assessment scenario differed
based on whether EPA relied on one of
several different animal studies or a
human study for the Point of Departure
for that scenario. For levels of concerns
derived from a Point of Departure from
an animal study, EPA generally applied
a 100X safety factor (10X for
interspecies variability and 10X for
intraspecies variability). Based on a
weight-of-the-evidence evaluation, EPA
removed the 10X FQPA safety factor for
risk assessments based on an animal
study. (See Table 1). EPAs weight-of-
the-evidence evaluation concluded that
(1) the toxicity database was complete;
(2) most of the data indicated no
increased sensitivity in the young and
the only evidence of increased
sensitivity occurred at levels well above
the Points of Departure used for
establishing the levels of concern; and
(3) its estimate of human exposure to
dichlorvos was not understated.
For levels of concerns derived from a
Point of Departure from the human
study, EPA applied a 10X safety factor
for intraspecies variability and a 3X
FQPA safety factor. (72 FR 68694
68695). No interspecies factor was
applied because EPA was not
extrapolating a level of concern in
humans from a dose in an animal study.
The weight-of-the-evidence balance for
the FQPA safety factor was slightly
different for risk assessments relying on
the Gledhill human study for the Point
of Departure. In addition to all of the
considerations pertaining to the
assessments with an animal-derived
Point of Departure, the Gledhill-based
risk assessments introduced another
factor to considernamely, that the
Gledhill study raised a data
completeness issue due to the fact that
it only identified a LOAEL. This latter
factor convinced EPA to retain a portion
of the FQPA safety factor when relying
on the human study for the Point of
Departure. EPA concluded, however,
that reliable data supported reduction of
the 10X factor to 3X because the effect
seen at the LOAEL in that study was so
marginal (16 percent RBC cholinesterase
inhibition) that a lower dose would
have been unlikely to detect any adverse
effect. (72 FR 6869468695; see Table
1).
TABLE 1SUMMARY OF RISK ASSESSMENT SCENARIOS, POPULATION GROUPS, AND UNCERTAINTY/SAFETY FACTORS FOR
DICHLORVOS
Scenario
Study from which point
of departure taken
Age and species of
study subjects
Population groups covered
by risk assessment
Uncertainty/safety factors
Acute Dietary ................ Rat acute oral cholin-
esterase study.
Adult rats ..................... All population groups, in-
cluding infants and chil-
dren.
Interspecies10X; Intraspecies
10X; FQPA1X.
Chronic Dietary ............ 1-year dog study .......... Adult dogs .................... All population groups, in-
cluding infants and chil-
dren.
Interspecies10X; Intraspecies
10X; FQPA1X.
Short-term Incidental
Oral.
Human 21-day oral
study.
Adult humans ............... All population groups, in-
cluding infants and chil-
dren.
Interspecies1X; Intraspecies
10X; FQPA3X.
Acute Dermal and
Acute Incidental Oral.
Rat acute oral cholin-
esterase study.
Adult rats ..................... All population groups, in-
cluding infants and chil-
dren.
Interspecies10X; Intraspecies
10X; FQPA1X.
Short-, Intermediate-
and Long-term Der-
mal.
Human 21-day oral
study.
Adult humans ............... All population groups, in-
cluding infants and chil-
dren.
Interspecies1X; Intraspecies
10X; FQPA3X.
Acute Inhalation ........... Rat acute oral cholin-
esterase study.
Adult rats ..................... All population groups, in-
cluding infants and chil-
dren.
Interspecies10X; Intraspecies
10X; FQPA1X.
Short- and Inter-
mediate-term Inhala-
tion.
Human 21-day oral
study.
Adult humans ............... All population groups, in-
cluding infants and chil-
dren.
Interspecies1X; Intraspecies
10X; FQPA3X.
Long-term Inhalation .... 2-year rat inhalation
study.
Adult rats ..................... All population groups, in-
cluding infants and chil-
dren.
Interspecies10X; Intraspecies
3X; FQPA1X.
V. NRDCs Petition to Revoke
Dichlorvos Tolerances and the
Administrative Proceedings on the
Petition
A. NRDCs Petition and EPAs Denial of
the Petition
On June 2, 2006, the NRDC filed a
petition with EPA which, among other
things, requested that EPA conclude the
dichlorvos tolerance reassessment
process by August 3, 2006, with a
finding that the dichlorvos tolerances do
not meet the FFDCA safety standard and
issue a final rule by August 3, 2006,
revoking all dichlorvos tolerances.
NRDCs petition contained dozens of
claims as to why dichlorvos FFDCA
tolerances should be revoked. After
carefully considering all of NRDCs
claims, the public comment received on
the petition, and a revised risk
assessment EPA conducted in response
to the petition, EPA issued an order
pursuant to FFDCA section 408(d)(4)(iii)
denying the request to revoke
dichlorvos FFDCA tolerances. (72 FR
68662, December 5, 2007).
B. NRDCs Objections and EPAs Denial
of the Objections
On February 1, 2008, NRDC filed,
pursuant to FFDCA section 408(g)(2),
objections to EPAs denial of its
tolerance revocation petition and
requested a hearing on those objections.
NRDCs objections and requests for
hearing included two main claims: (1)
That EPA has unlawfully failed to retain
the full 10X safety factor for the
protection of infants and children; and
(2) that it was unlawful for EPA to rely
on a toxicity study for dichlorvos (the
Gledhill study) that was conducted with
humans. Because NRDC did not seek
judicial review on EPAs substantive
conclusions on the latter issue but only
challenged EPAs denial of a hearing on
the issue, and because the Second
Circuit court on review did not reach
the hearing issue, the Gledhill study is
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further discussed only to the extent it
bears on the FQPA safety factor
decision.
NRDC cited several grounds for its
assertion that EPA unlawfully lowered
the 10X childrens safety factor.
However, only two of its arguments
were later raised in NRDCs judicial
challenge to EPAs decision. First,
NRDC claimed that EPA lacked
adequate data on dichlorvos potential
effects on the endocrine system because
EPA had not received data on endocrine
effects through the Endocrine Disruptor
Screening Program. Second, NRDC
argued that EPAs choice of a 3X
additional safety factor was based on
generic data and not [ ] on any data
specific to DDVP. (Ref. 1 at 5).
EPA denied both of NRDCs reasons
for its objection to the choice of a 3X
FQPA factor. EPA rejected NRDCs
endocrine data argument on both legal
and factual grounds. EPA concluded
that the statute gave it broad discretion
to determine what data are needed in
making a determination on the FQPA
safety factor and that nothing in section
408(p), creating the Endocrine Disruptor
Screening Program, overrode that broad
discretion. As a factual matter, EPA
found that it had adequate data on
endocrine effects from the existing
dichlorvos database. (73 FR 42697
42698).
EPA also rejected NRDCs claim that
it relied on wholly generic data, rather
than dichlorvos-specific data, in
choosing a 3X FQPA factor. NRDCs
argument here was that EPA chose 3X
because EPA considers 3X to be a half-
value of a 10X factor rather than on data
pertaining to dichlorvos. In response,
EPA noted that its petition denial order
had comprehensively restated its basis
for its FQPA safety factor decision, and
that restatement focused in great detail
on the toxicology data for dichlorvos,
particularly, the data on the sensitivity
of the young. (73 FR 42695). EPA further
pointed out that although the statutory
considerations underlying the FQPA
safety factor generally supported
removal of the 10X additional factor, the
reason EPA chose to retain a 3X FQPA
safety factor for some assessments was
directly tied to a deficiency in a
dichlorvos study (the Gledhill study)
that is critical to those assessments.
(Id.). Thus, there was no basis for
NRDCs claim that EPA had not relied
on dichlorvos-specific data in making
its FQPA safety factor decision.
VI. Judicial Review of EPAs Denial
Order
A. NRDCs Petition for Judicial Review
and the Matters Presented on Review
NRDC petitioned the Second Circuit
court for review of EPAs denial of
certain of its objections and hearing
requests. As to its hearing requests,
NRDC argued that EPA improperly
denied its request for a hearing on
statistical and informed consent issues
presented by the Gledhill study. As to
its objections, NRDC asserted (1) that, as
a legal matter, EPA was required to
retain the 10X FQPA factor if it did not
have data from the Endocrine Disruptor
Screening Program; and (2) that EPAs
choice of a 3X FQPA factor was
arbitrary and capricious because EPA
had relied upon generic assertions that
unlawfully fail to take into account any
dichlorvos-specific information for
infants and children. (Ref. 28 at 37).
NRDC supported the latter argument in
the following fashion. First, it argued
that EPA chose 3X solely because it was
half of 10X. Second, NRDC asserted that
EPAs consideration of the Gledhill
study did not constitute dichlorvos-
specific information for infants and
children because the Gledhill study
was conducted with adults. Third,
NRDC dismissed EPAs reliance on
dichlorvos developmental studies in
animals on the ground that a prior case
had held that EPA had not, in that
particular case, offered an adequate
explanation of how the data on
developing animals supported the
FQPA factor chosen.
In response, EPA explained that
NRDCs focus on EPAs discussion of
why 3X is considered half of 10X
ignored the central part of EPAs
analysis: An assessment of whether the
dichlorvos data showed 3X would be
safe. EPA responded to the claim of a
failure to consider dichlorvos-specific
information for infants and children by
noting that the Gledhill study had not
been considered in isolation in the
decision on the FQPA safety factor but
in the context of the animal data
showing no difference in adult-young
sensitivity because it was that very
data that shows why the Gledhill study
is appropriate for the entire population
* * * (Ref. 29 at 63). Further, EPA
noted that NRDCs argument that EPA
reliance on animal sensitivity data does
not justify a choice of 3X contradicted
the core of NRDCs claimthat EPA had
not considered dichlorvos-specific
information for infants and children.
(Id. at 62).
B. The Second Circuit Courts Decision
on Review
On review, the Second Circuit court
addressed three issues: (1) Was EPA
legally compelled to retain the 10X
FQPA safety factor in the absence of
obtaining data from the Endocrine
Disruptor Screening Program; (2) did
EPA adequately explain its decision on
the FQPA safety factor; and (3) was
NRDC entitled to an evidentiary hearing
with regard to its claims regarding the
alleged statistical and informed consent
deficiencies in the Gledhill study.
1. Endocrine data. The court held that
EPA was not statutorily required to
retain the 10X FQPA factor in
circumstances where it has not obtained
the data required under the Endocrine
Disruptor Screening Program. (658 F.3d
at 219). The court found no indication
in the statute or legislative history that
Congress * * * intended the childrens
safety factor to be mandatory in
assessing the risks of all pesticides until
EPA completed the estrogen disruptor
screening program * * * (Id.).
According to the court, Congress
allowed EPA to determine, based on all
available data, whether there was
reliable data supporting a reduced or
waived childrens safety factor * * *
(Id.).
2. FQPA safety factor. Contrary to the
narrow FQPA safety factor issue
presented to EPA in NRDCs
objectionsdid EPAs decision on the
FQPA safety factor rely on a generic
assertion [instead of being] based on any
data specific to DDVP?the court
framed the issue on the FQPA factor
more broadly: NRDC now seeks review
of that EPA order, arguing in part that
EPA failed to explain why, when
assessing the safety of dichlorvos for
certain exposure scenarios, EPA did not
apply an additional tenfold childrens
safety factor, to account for potential
pre- and post-natal toxicity and
completeness of data with respect to
exposure and toxicity to infants and
children. (Id. at 201).
The court found that, for risk
assessments relying on the Gledhill
study in deriving the Point of Departure,
EPA had provided essentially no
explanation with regard to the FQPA
safety factor. The court noted that EPA
had retained an additional 3X safety
factor for these risk assessments but the
court concluded that it was EPAs
express position that this factor was not
based on any evaluation of the risks to
infants and children but rather was
intended to address the lack of NOAEL
in the Gledhill study only. According to
the court, [i]n EPAs IRED and two
published orders, EPA consistently
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reiterated this position and declined to
claim that the 3X factor was based on
any evaluation of the risk to infants and
children. (Id. at 216). Further, the court
concluded that, unlike the risk
assessments that were not based on the
Gledhill study, EPA did not rely on the
developmental animal studies showing
no differential sensitivity between adult
and juvenile animals. According to the
court, EPA explicitly stated that it did
not rely on any animal studies. (Id. at
217). The court thought this abnegation
of reliance of animal studies was
confirmed by EPAs decision not to
apply an interspecies factor to the
Gledhill-based assessments. (Id.).
Although the court noted that EPA
called the 3X factor a FQPA factor, the
court found that label to be insufficient
absent an explanation [i]n []either its
IRED []or its two orders [of] how the 3X
factor was designed to take into account
potential pre- and post-natal toxicity
and completeness of the data with
respect to infants and children. (Id.).
The court held that EPAs reasoning
concerning the marginal effects seen at
the LOAEL in the Gledhill study did not
constitute a sufficient explanation
because EPA did not relate that
reasoning to potential pre- and post-
natal toxicity and completeness of the
data with respect to infants and
children. (Id.). Finally, the court
questioned EPAs analysis that the
effects at the LOAEL were marginal
suggesting that EPA had not done a
proper statistical analysis. (Id. at 218).
Accordingly, the court concluded
that, as to risk assessments that used the
Gledhill study to derive the Point of
Departure, EPAs order was arbitrary
and capricious due to EPAs failure to
provide an adequate explanation with
regard to its decision on the FQPA
safety factor. (Id.). Given this
conclusion, the court vacated the aspect
of EPAs order pertaining to risk
assessments based on the Gledhill study
and remanded the matter to EPA. (Id. at
220).
3. Evidentiary hearing. With regard to
NRDCs request for an evidentiary
hearing on issues it raised concerning
the Gledhill study, the court determined
that it did not need to resolve this
question given its disposition of the
FQPA safety factor issue. As the court
pointed out, EPA may decide, on
remand, not to rely on the Gledhill
study or to rely on the study in a
different manner or for different
reasons. (Id. at 219).
VII. FQPA Safety Factor Determination
for Gledhill-based Assessments
A. Introduction
FFDCA section 408(b)(2)(C) expressly
requires EPA to apply a default
additional 10X safety factor for the
protection of infants and children
unless EPA determines, based on
reliable data, that a different factor
would be safe. Under the terms of the
statute, this additional safety factor is
imposed to take into account potential
pre- and post-natal toxicity and
completeness of the data with respect to
exposure and toxicity to infants and
children. (21 U.S.C. 346a(b)(2)(C)). To
implement these statutory commands,
EPA has released detailed guidance that
advises EPA risk assessors in making
decisions on the FQPA safety factor to
focus on potential pre- and post-natal
toxicity and the completeness of the
toxicity and exposure databases. In the
dichlorvos IRED and the two orders
responding to NRDCS dichlorvos
petition, EPA devoted several pages to
explaining how its decision to apply a
3X FQPA safety factor complied with
the statutory directives on the FQPA
safety factor and was consistent with its
policy guidance document. (See Ref. 3
at 128132; 72 FR 6869468695; 73 FR
4269542696). From start to finish this
discussion centered on the issues of
completeness of the toxicity and
exposure databases for dichlorvos and
the potential increased sensitivity of
infants and children to dichlorvos from
pre- and post-natal toxicity.
Nevertheless, in vacating, in part,
EPAs dichlorvos order, the Second
Circuit court held that there was a
complete absence of an explanation
from EPA as to how EPAs choice of a
safety factor protected infants and
children. As the court repeatedly stated,
EPA did not explain why a childrens
safety factor less than 10X would take
into account potential pre- and post-
natal toxicity and completeness of the
data with respect to infants and
children. (658 F.3d at 217). In fact, the
court rejected EPAs claim to have
applied any FQPA safety factor at all.
According to the court, the additional
safety factor applied by EPA could not
be considered a FQPA safety factor
given what the court viewed as EPAs
denial that the additional safety factor
had anything to do with infants and
children. (Id. at 211, 216).
Following a close review of EPAs
prior explanations and the courts
opinion, EPA now recognizes that the
discussion of the FQPA safety factor in
its dichlorvos IRED and orders was less
than transparent. EPAs explanation for
its position on the FQPA safety factor
used, at times, a form of short-hand that
hid rather than elucidated its reasoning.
In particular, EPAs short-hand appears
to have led the court to the following
two misunderstandings: (1) That EPAs
use of a 3X safety factor to address the
lack of a NOAEL in the Gledhill study
had nothing to do with the safety of
infants and children; and (2) that EPA
did not consider the animal
developmental data in making a
determination on the FQPA safety factor
for assessments relying on the Gledhill
study. Clarification of EPAs position on
these two issues is critical to an
understanding of EPAs FQPA safety
factor decision. Accordingly, on
remand, EPA has first addressed how
the Gledhill-based assessments relate to
protection of infants and children and
how EPA used animal developmental
data in these assessments. Only then
does EPA offer its explanation as to
how, in light of the courts opinion, its
choice of a FQPA safety factor for the
Gledhill-based risk assessment is
protective of the safety of infants and
children, as required by FFDCA section
408(b)(2)(C).
B. Clarifications
1. Applying a FQPA safety factor to
address the lack of a NOAEL in the
Gledhill Study. Numerous times in the
IRED as well as its dichlorvos orders,
EPA stated that an additional 3X safety
factor was applied in risk assessments
using the LOAEL in the Gledhill study
as the Point of Departure due to a lack
of a NOAEL in the study. (Ref. 3 at 133;
658 F.3d at 217 (collecting cites)). EPA
explained that the safety factor was used
to project a NOAEL for the study. The
court interpreted these statements as
meaning the 3X factor had nothing to do
with the protection to infants and
children. According to the court, EPA
explained that the 3X factor [used in
conjunction with the Gledhill study]
was not based on any risk to children
or infants, but accounted for EPAs
failure to identify a NOAEL in the
[Gledhill] study. (Id. at 214).
Certainly, the narrow issue addressed by
the use of the 3X factor was the lack of
a NOAEL in the Gledhill study.
However, extrapolating a NOAEL
through use of a safety factor is not an
end in itself. Rather, the safety factor
was used to ensure that dichlorvos risk
assessments relying on the LOAEL in
the Gledhill study adequately protect
the population groups covered by those
assessments. Importantly, the
population groups covered by the
Gledhill-based assessments include
infants and children. Thus, the 3X factor
to account for the lack of a NOAEL in
the Gledhill study was critical to
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protecting infants and children.
However, EPAs orders and IRED failed
to make this linkage between the 3X
factor and the safety of infants and
children clear. That linkage is fleshed
out in detail below.
As discussed in Unit III.B.2.v., prior
to the passage of FQPA, EPA had
applied an additional uncertainty factor
to address a data deficiency such as
when adverse effects were seen in the
lowest dose of a toxicological study (i.e.,
when the study did not provide a
NOAEL). Such a factor is used to
essentially extrapolate a NOAEL for the
study. Without an additional safety
factor, there is uncertainty as to whether
reliance on the LOAEL as a Point of
Departure in calculating a RfD/PAD or
MOE is adequately protective of the
populations covered by the risk
assessment scenario relying on that RfD/
PAD or MOE.
EPA has interpreted the FQPA as
codifying this LOAEL-to-NOAEL
uncertainty factor as a FQPA safety
factor when the factor is used in a
portion of a risk assessment (i.e., in a
particular exposure scenario) that
assesses, at least in part, the risk to
infants and children. (Ref. 10 at 1116,
A3A4). The logic here is
straightforward. A study that fails to
produce a NOAEL is considered to be a
data deficiency that affects the
completeness of the toxicity database.
The statute specifically references
completeness of the toxicity database as
a reason for requiring an additional
safety factor for the protection of infants
and children. Thus, when the LOAEL
from a study that lacks a NOAEL is
chosen for the Point of Departure for a
risk assessment applying to infants,
children, or women of child-bearing age
(for the purpose of protecting fetuses),
the safety factor used to address this
data deficiency is a FQPA safety factor
for the protection of infants and
children. This is the case whether or not
the Point of Departure is used for
infants, children, or women of child-
bearing age only or for both adults and
all other population groups, including
infants and children. Many risk
assessments for particular exposure
scenarios use the same Point of
Departure for both adults and infants
and children because frequently the
relevant toxicity data show a lack of
differential sensitivity between adults
and the young. However, use in a risk
assessment of the same Point of
Departure for both adults and the young
does not make the FQPA safety factor
provision inapposite. EPAs position is
that any assessment of risk for a
particular exposure scenario that
includes, at least in part, an assessment
of risks to infants and children triggers
the FQPA safety factor provision.
Nothing in section 408(b)(2)(C) limits
the safety factor provision only to
situations where infants or children are
more sensitive than adults. For similar
reasons, it is also irrelevant to
application of the FQPA safety factor
provision whether the Point of
Departure is from a study involving
juveniles or adults. Points of Departure
for assessing risks to infants and
children are based on the studies
showing the most sensitive effects,
whether the studies are conducted in
adults or juveniles. (See Ref. 17 at 452
([C]hronic and subchronic tests in
[adult animals] have value in assessing
potential risks to children by, for
example, identifying target sites for
toxicity and providing dose-response
information that may be useful for
human safety assessment, irrespective of
life stage.). The critical factor for the
FQPA safety factor provision is whether
the study is being used for a Point of
Departure for assessing risk to infants
and children.
With this background, the connection
between the use of a 3X safety factor to
address the Gledhill study LOAEL and
the protection of the infants and
children can now be explicated.
Because the Gledhill study produced
cholinesterase effects at the lowest level
in the subchronic studies in the
dichlorvos database and the database
showed no age-related sensitivity, (see
discussion in Unit VII.C.), EPA chose
the Gledhill LOAEL as the Point of
Departure for assessing risks for short-
and intermediate-term exposure
scenarios to all population groups,
including infants and children. In other
words, the Gledhill LOAEL was selected
as the Point of Departure for all
population groups for these exposure
scenarios because the dichlorvos
database demonstrated that the Gledhill
study not only provided the best
measure of cholinesterase inhibition for
protecting adults but that it was the best
measure for protecting infants and
children. Nonetheless, EPA also
recognized that the data deficiency in
the Gledhill studythe failure of the
Gledhill study to identify a NOAEL
raises uncertainty as to what that study
indicates regarding the threshold below
which exposure to dichlorvos will not
result in cholinesterase inhibition. To
address this uncertainty and thus
protect the safety of all population
groups covered by the risk assessments,
including infants and children, EPA
chose to apply an additional safety
factor of 3X. This choice of a safety
factor was made under the rubric of the
FQPA safety factor provision because
the uncertainty raised by reliance on a
LOAEL both (1) affected the assessment
of the risk to infants and children; and
(2) was driven by a data deficiency
affecting the completeness of the
toxicity database. (73 FR 42695; 72 FR
6869468695; Ref. 3 at 133, 134). Thus,
the additional 3X safety factor used in
assessments relying on the Gledhill
study was not simply to address the lack
of a NOAEL in that study but rather to
ensure the protection of infants and
children (among others) given that a
LOAEL was used as the Point of
Departure for assessing risk to infants
and children for several exposure
scenarios. Regrettably, the connection
between a safety factor used to address
the lack of a NOAEL in a study in adults
and the protection of infants and
children was not transparent in EPAs
IRED or its denial of NRDCs petition
and objections. That linkage should now
be clear.
2. Reliance on animal developmental
data. EPAs FQPA safety factor policy
emphasizes the importance of
considering the weight-of-evidence
analyses for the completeness of the
toxicity database, the degree of concern
for pre- and postnatal toxicity, and
results of the exposure assessments in
making a safety factor determination.
(Ref. 10 at 50). In particular, the policy
stresses taking into account all
pertinent information in evaluating
potential pre- and postnatal toxicity.
(Id. at 29). The policy recognizes that
human data on pre- and postnatal
toxicity is difficult to obtain and for
that reason discusses, in detail, how
animal developmental data should be
considered in evaluating the potential
for pre- and post-natal toxicity in
humans. (Id. at 2831). Although EPA
did discuss the animal data on juvenile
sensitivity in its FQPA safety factor
determination, (72 FR 6869468695),
the court concluded that EPA had not
considered that data in making a
determination on the FQPA safety factor
for assessments relying on the Gledhill
study for the Point of Departure.
To support this conclusion, the court
opined that EPAs orders specifically
referenced the animal developmental
studies in conjunction with the safety
factor determination for the non-
Gledhill-based assessments but had not
done so as to the Gledhill-based
assessments. The court is correct that
EPA did not clearly explain that its
discussion of the animal developmental
data related both to the assessments
based on a Point of Departure from
animal data as well as the assessments
relying on the Gledhill study for the
Point of Departure. EPAs discussion of
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54414 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
1
The one human study that was not used for
selection of a Point of Departure was conducted
with the pesticide oxamyl. The oxamyl human
study was submitted for the purpose of justifying
a reduction of the 10X interspecies factor despite
use of an animal study for the Point of Departure.
The Human Studies Review Board concluded that
the intentional human dosing study of oxamyl was
sufficiently robust to be used for reducing the 10x
inter-species (i.e. animal to human) uncertainty
factor in the cumulative risk assessment for the N-
methyl carbamates. (Ref. 36 at 28). Thus, it is not
even a given that a full interspecies factor will be
applied when an animal study is relied upon to
extrapolate a dose in humans.
the Gledhill study, and the data
deficiency therein, followed the analysis
of the animal developmental data but
did not directly reference that data or
the statutory considerations bearing on
the FQPA safety factor decision. (Id.).
To avoid this error in its revised safety
factor finding below, EPA has included
a discussion of the data deficiency in
the Gledhill study under the topic of
completeness of the data with respect
to * * * toxicity and also explicitly
discussed how the statutory
consideration pertaining to the potential
for pre- or post-natal toxicity, and the
animal data bearing on this issue, was
considered in the context of the
Gledhill-based assessments.
The court also concluded that EPA
explicitly stated that it did not rely on
any animal studies in connection with
the Gledhill-based assessments, (658
F.3d at 217), citing to language in the
IRED that specified that where the Point
of Departure was chosen from the
Gledhill study there was no need to
account for interspecies extrapolation
* * * [s]ince the study was conducted
in human subjects. (Ref. 3 at 133, 134).
According to the court, [w]hen EPA
did rely on the animal studies * * * [it]
properly applied a safety factor of 10X
for interspecies differences. (658
F.23d at 217). The court appears to have
drawn the conclusion that the
interspecies factor should be applied
whenever EPA considers animal studies
in any aspect of the risk assessment.
Thus, the court reasoned that because
EPA did not apply an interspecies factor
for the Gledhill-based assessments, it
could not have considered the animal
developmental data in the FQPA safety
factor determination for dichlorvos.
The court has misapprehended the
reason EPA uses an interspecies factor
in risk assessments. The factor is not
automatically applied whenever animal
data are considered in any aspect of a
risk assessment. Rather, as explained in
Unit III.B.2., the interspecies factor is
used when extrapolating from a dose in
an animal study (generally a NOAEL or
LOAEL) on a milligram-per-kilogram of
body weight basis to a dose in humans.
(See Ref. 10 at 10 (an interspecies factor
is used if animal data have been used
as the basis for deriving the hazard
values). The interspecies factor is
designed to account for possible
toxicokinetic and toxicodynamic
differences in humans and laboratory
animals that may result in differences in
internal dose and organ sensitivity
between humans and animals. Thus, in
the dichlorvos animal assessments in
which EPA relied on animal data for the
Point of Departure, EPA did apply an
interspecies factor. For those
assessments, EPA was either
extrapolating a RfD for humans from
animal data or comparing the margin
between human exposure and the dose
in animals that was judged to be a
NOAEL. No interspecies factor was
necessary in assessments based on the
LOAEL from the Gledhill study because
EPA was not extrapolating from a
NOAEL or LOAEL in laboratory animals
to humans or comparing human
exposure to a dose from an animal
study. Rather, EPA had data in
humansthe Gledhill studyand was
relying on that data for the Point of
Departure. There was no need to
account for the toxicokinetic and
toxicodynamics differences between
humans and animals when deriving a
safe dose for humans from a study
conducted with humans.
EPA, however, did rely on the animal
developmental data in the FQPA safety
factor determination for the Gledhill-
based assessments. But that reliance was
for a purpose distinct and separate from
use of the data for extrapolating a dose
from animals to humans. In accordance
with Agency FQPA safety factor policy,
EPA considered the dichlorvos animal
developmental data with regard to the
important information it provides on
whether the 10X intraspecies factor for
dichlorvos is protective of infants and
children. (Ref. 10 at 29). A primary
focus of the animal developmental data
(the rat and rabbit developmental
studies, the rat reproduction study, the
rat developmental neurotoxicity study,
and comparative cholinesterase studies)
is on the relative sensitivity of adult and
juvenile animals. Because EPA would
rarely have data on the relative
sensitivity among different age groups of
humans to a pesticide, these animal data
help inform, as EPA policy makes clear,
whether the 10X intraspecies factor is
sufficiently protective of infants and
children. (Id.).
Considering animal developmental
data in evaluating the intraspecies factor
is a standard part of EPAs risk
assessment process. As discussed in
Unit III.B.2 and above, animal
developmental data are central both to
establishing the justification for the 10X
default value for the intraspecies factor
and for evaluating the protectiveness of
this default value for specific chemicals.
Although broad-based surveys of data
on adult/juvenile sensitivity in both
humans and animals generally support
the use of a 10X default value for the
intraspecies factor, there is wide
recognition that the possibility of
heightened sensitivity in infants and
children warrants obtaining
particularized data on juvenile/adult
animal sensitivity for individual
chemical risk assessments. When these
data are available, they may indicate
that there is no heightened concern
warranting an additional safety factor or
that an additional factor is necessary
above and beyond the default 10X value
for the intraspecies factor. In a few
cases, EPA has even relied, at least in
part, on animal data as supporting a
reduction in the default 10X
intraspecies factor.
Yet, despite the centrality of animal
data to the justification for and selection
of the intraspecies factor, EPA is not
aware of any instance where an
interspecies factor has been applied
solely for reliance on animal data on
adult-juvenile sensitivity to evaluate the
protectiveness of the human
intraspecies factor. For example, EPAs
long-established and consistent practice
is not to apply an interspecies factor
when relying on a human study for the
Point of Departure even though a
decision on the intraspecies factor is
still an essential part of such
assessments. Dourson et al. collected a
summary of all EPAs RfDs on EPAs
Integrated Risk Information System
(IRIS) as of May 2000 that used human
data for the Point of Departure. (Ref. 17).
All 24 such assessments identified used
an interspecies factor of 1X (i.e., no
factor). EPA has identified 9 additional
such risk assessments on IRIS post-
dating May 2000, and each one of those
also does not apply an interspecies
factor. (Ref. 30). Even more on point are
EPA pesticide risk assessments relying
on human data. Since the promulgation
of the 2006 Human Research Rule, EPA
has accepted 10 human studies for use
in pesticide risk assessments other than
the Gledhill study. (Id.). A Point of
Departure was selected from 9 of those
10 studies.
1
Yet, in none of those
assessments did EPA apply an
interspecies factor in conjunction with a
Point of Departure from a human study
even though the assessments do not
focus on the human data exclusively.
Animal developmental data play a
critical part in these assessments,
particularly where a FQPA safety factor
analysis is required.
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The FQPA safety factor analysis in the
tolerance reassessment document for the
pesticide ethephon provides a good
example of this. With ethephon, [t]he
conventional UF of 10X for interspecies
extrapolation was not applied because
the endpoint selected for the risk
assessment was from a human study.
(Ref. 31 at 6). At the same time, EPA
noted that:
The Agency concluded that no FQPA
Safety Factor is necessary to protect the
safety of infants and children in assessing
ethephon exposure and risks because the
toxicology database for ethephon contains
acceptable guideline developmental and
reproductive studies as well as acute and
subchronic neurotoxicity studies. [Guideline
studies are conducted in animals. (40 CFR
158.500)]. The Agency also concluded that
there is no quantitative or qualitative
evidence of increased susceptibility
following in utero or postnatal exposure in
any of the developmental or reproductive
studies. The RfDs and toxicity endpoints
established are protective of pre/postnatal
toxicity following acute and chronic
exposures.
(Id.). A variation on the approach in
ethephon is the safety/uncertainty
factors chosen in assessing the risk of
the pesticide methomyl. (Ref. 32 at 5).
For the methomyl risk assessments that
relied on a human study for the Point
of Departure, the Agency applied a 10X
intraspecies, a 1X interspecies factor (no
extrapolation from a dose in animals to
humans), and a 2X (data-derived) FQPA
safety factor. The 2X FQPA factor was
chosen because, unlike dichlorvos, the
adult/juvenile comparative
cholinesterase data in rats showed that
juveniles were approximately twice as
sensitive to methomyl as adults. Thus,
a 2X FQPA safety factor was applied to
ensure that the 10X intraspecies factor
was sufficiently protective. However,
just as with dichlorvos and ethephon,
no interspecies factor (1X) was used
because the Point of Departure was
derived from a human, not animal,
study. A final example illustrating that
consideration of animal data in
conjunction with choice of a Point of
Departure from a human study does not
result in use of a 10X interspecies factor
is the assessment of the pesticide
chloropicrin. With chloropicrin, EPA
relied upon a human study for the Point
of Departure and thus no interspecies
factor (1X) was applied. However, EPAs
consideration of the data from humans
and animals also led EPA to conclude
that no intraspecies factor (1X) was
needed either. (Ref. 33). No interspecies
factor was applied as a result of
consideration of animal data in
evaluating the need for an intraspecies
factor.
Use of a 10X interspecies factor for
reliance on animal developmental data
to evaluate the protectiveness of the
intraspecies factor would also lead to
illogical results. For example, animal
developmental data are now considered
so critical to evaluating pre- and post-
natal toxicity that the FQPA imposes a
presumptive 10X safety factor in their
absence. Yet, once the data are
submitted, it does not make sense to
replace the 10X safety factor that
addressed their absence with a safety
factor of equivalent value to address
their mere use for evaluation of pre- and
post-natal toxicity. Leaving aside what
the animal developmental data show,
there cannot be equal need for safety
factors both in the absence and presence
of adequate animal developmental data.
In sum, it would not only be
unprecedented, but inconsistent with
well-established safety factor practice,
to suggest that the mere consideration of
animal data in evaluating the
protectiveness of the intraspecies factor
triggers application of an interspecies
factor. Importantly, under the FFDCA
section 408, EPA is only authorized to
consider safety factors which in the
opinion of experts qualified by scientific
training and experience to evaluate the
safety of food additives are generally
recognized as appropriate for the use of
animal experimentation data. 21 U.S.C.
346a(b)(2)(D)(ix).
Unfortunately, EPAs short-hand
description of its FQPA determination
misled the court regarding EPAs
consideration of the animal
developmental data. Further, EPAs
brief explanation for why it did not
apply an interspecies factor did not
clarify the situation. This, in turn,
resulted in confusion regarding the role
of the interspecies factor. EPAs revised
FQPA safety factor explanation attempts
to avoid such pitfalls.
C. Revised FQPA Safety Factor Decision
1. Introduction and background. The
Second Circuit court has vacated that
portion of EPAs order on NRDCs
objections assessing the risk of
dichlorvos based on the Gledhill study
* * * . (658 F.3d at 220). The court
found that EPA had failed to explain
why it did not use a 10X childrens
safety factor for those assessments.
(Id.).
In the IRED, EPA relied on the
Gledhill human study for selection of
the Point of Departure for assessing
dermal (short-, intermediate-, and long-
term), incidental oral (short-term), and
inhalation (short- and intermediate-
term) risk for all population subgroups,
including infants and children. Agency-
wide guidance on Reference Dose
selection emphasizes that human data
provides the best source for assessing
human risk: Adequate human data are
the most relevant for assessing risks to
humans. When sufficient human data
are available to describe the exposure-
response relationship for an adverse
outcome(s) that is judged to be the most
sensitive effect(s), reference values
should be based on human data. (Ref.
19 at 412; see Ref. 10 at 33 (human
data are the most relevant data for
assessing health risks)). EPA chose the
Gledhill study, in particular, for
determination of the Point of Departure
because it evaluated cholinesterase
inhibition, the most sensitive effect for
dichlorvos as shown by animals studies,
and because the Gledhill study has the
lowest LOAEL established for RBC
cholinesterase inhibition in a repeated
oral exposure to dichlorvos. (Ref. 3 at
133). Specifically, it was the lowest
LOAEL considering both the human and
animal studies and cholinesterase
effects in adults and juveniles. EPAs
determination that the Gledhill study
is sufficiently robust for developing a
Point of Departure for estimating
dermal, incidental oral, and inhalation
risk from exposure to DDVP, was
concurred in by the Human Studies
Review Board, an independent expert
panel of scientists. (72 FR 68675).
The level of concern for the risk
assessments relying on the Gledhill
study for the Point of Departure was
expressed in terms of a target MOE of
30. That value was based on an
intraspecies uncertainty factor of 10X
and a FQPA safety factor of 3X.
Although EPA concluded that neither
the data on pre- or postnatal toxicity or
on exposure to dichlorvos showed a
need for a FQPA safety factor, EPA
found that the data deficiency with
regard to the Gledhill studynamely,
its lack of a NOAELjustified the
retention of a 3X FQPA safety factor.
2. FQPA safety factor decision. In
making a FQPA safety factor
determination, EPA follows a weight-of-
the-evidence approach that focuses on
the three considerations explicitly noted
in FFDCA section 408(b)(2)(C): the
completeness of the toxicity database;
the potential for pre- and post-natal
toxicity; and the completeness of the
exposure database. (Ref. 10 at iv). Each
of those considerations is discussed
below.
i. Completeness of the toxicity
database. In ruling on NRDCs petition,
EPA concluded that it had a complete
toxicity database under the pesticide
data requirements in 40 CFR part 158.
This included all required data
specifically pertaining to effects on the
youngdevelopmental studies in two
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54416 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
2
Statistical significance is a term used to describe
observed data that differ from the overall
distribution of values by a level that is unlikely to
be due to random error. Statistical significance is
examined in terms of the probability of the
observed differences occurring. By convention,
observed values that have a 5 or 1 percent chance
of occurring are treated as statistically significant,
with 1 percent being the more rigorous standard.
(Ref. 43).
species (rat and rabbit); a two-generation
reproduction study in rats; and a
developmental neurotoxicity study in
rats. EPA also had comparative
cholinesterase inhibition data in adult
and juvenile rats. EPA did not have data
submitted pursuant to the Endocrine
Disruptor Screening Program, but for the
reasons explained in its order denying
NRDCs petition, EPA has concluded
that it has adequate data on dichlorvos
endocrine effects for the purposes of its
FQPA safety factor decision. (73 FR
4269742698).
In addition to these standard animal
toxicity studies, the dichlorvos
registrant had submitted one toxicity
study in humans, the Gledhill study,
that EPA had determined was in
compliance with its Human Research
Rule. (40 CFR part 26). As discussed
below, there is a data deficiency issue
with this study that is pertinent to the
completeness of the toxicity database
consideration. Although this study was
conducted in adults, it is highly relevant
to the protection of infants and children
because EPA has, for the reasons
explained in Units VII.B.1. and VII.C.1,
selected the Gledhill study for
identifying a Point of Departure for as to
several risk assessment scenarios for all
population groups, including infants
and children. Thus, how EPA addresses
the data deficiency in the Gledhill study
will directly affect how it assesses risks
to infants and children.
The Gledhill study was a repeat dose
study measuring RBC cholinesterase
inhibition in control and dichlorvos-
treated human subjects. Only a single
dose level (7 mg) was used in the study.
Cholinesterase inhibition in the treated
subjects reached a level of 16 percent by
day 18 of treatment (i.e., cholinesterase
activity levels declined to 84 percent of
the pre-dose mean by day 18). As shown
in Table 2 below (reprinted from EPAs
Data Evaluation Record of the Gledhill
study and the Gledhill study report), the
statistical analysis of the results of the
Gledhill study shows a high level of
statistical significance (at the 1 percent
level)
2
for cholinesterase activity levels
both between controls and treated
subjects and between pre- and post-
dosing cholinesterase levels for treated
subjects for most days post-dosing.
TABLE 2RESULTS OF THE GLEDHILL STUDY
Timepoint
Placebo (n = 3) Dosed (n = 6)
Mean SD
% pre-dose
mean
Mean SD % pre-dose mean
Pre-dose ........... 18483 .52 1346 .91 100 17738.33 1713.50 100
Day 1 ................ 17930 .00 1404 .24 97 17628.33 1914.45 99
Day 2 ................ 18180 .00 1564 .7 98 16816.67* 1546.63 95
Day 4 ................ 18740 .00 1771 .13 101 16933.33** 1597.33 95
Day 7 ................ 18530 .00 1888 .36 100 16181.67**

1759.48 91
Day 9 ................ 18460 1007 .03 100 16708.33 2504.97 94
Day 11 .............. 19210 .00 1035 .95 104 16036.67**

1654.38 90
Day 14 .............. 18490 .00 1642 .35 100 15333.33**

1250.34 86
Day 16 .............. 17706 .67 2470 .15 96 15191.67**

1062.59 86
Day 18 .............. 18260 .00 2298 .87 99 14855.00**

1198.51 84
* Statistically significant difference from pre-dose at the 5% level (paired t-test).
** Statistically significant difference from pre-dose at the 1% level (paired t-test).

Statistically significant difference between placebo and dose groups at the 1% level (t-test, based on repeated measures of analysis of
covariance).
(Refs. 34 and 35).
EPA found these statistical results to
be sufficiently robust to support use
of the Gledhill study as the Point of
Departure. This judgment was
concurred on by the Human Studies
Review Board. (Ref. 36). The Board
relied upon the following aspects of the
study: The repeated dose approach
which allowed examination of the
sustained nature of RBC cholinesterase
inhibition; robust analysis of RBC
cholinesterase inhibition both in terms
of identifying pre-treatment levels and
consistency of response within and
between subjects; and the observation of
a low, but statistically significant RBC
cholinesterase inhibition response. (Id.
at 39). The HSRB concluded that
[a]lthough a study using a single dose
level is not ideal for establishing a
LOAEL, there was general consensus
that RBC cholinesterase is a well-
characterized endpoint for compounds
that inhibit acetylcholinesterase activity
and therefore, because the decreased
activity in RBC cholinesterase activity
observed in this study was at or near the
limit of what could be distinguished
from baseline values, it was unlikely
that a lower dose would produce a
measurable effect in RBC cholinesterase
activity. (Id. at 41).
There is one significant deficiency
with the Gledhill study, however.
Because the study used a single dose
level, and that dose was found to cause
an adverse effect on RBC cholinesterase
activity, the study does not identify a
NOAEL. As discussed earlier, this type
of deficiency is incorporated and
addressed as part of the FQPA safety
factor because it relates to the first
consideration noted in FFDCA section
408(b)(2)(C)completeness of the
toxicity database. (See Unit III.B.2.vi.).
In deciding what level of safety factor
is necessary to address this data
deficiency, EPA is guided by EPA
science policy on use of uncertainty
factors, the scientific literature on safety
factors, and EPA prior practice with
regard to FQPA safety factor decisions.
EPAs RfD policy recommends a default
value of 10X for an uncertainty factor
addressing the lack of a NOAEL but
makes clear that [t]he size of the
LOAEL-to-NOAEL uncertainty factor
may be altered, depending on the
magnitude and nature of the response at
the LOAEL. (Ref. 19 at 444). Further,
as discussed in Unit III.B.2.v, Dourson
et al. concluded that [t]he data indicate
that when faced with a LOAEL and not
a NOAEL, the choice of uncertainty
factor should generally depend on the
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SPA-015
54417 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
severity of the effect at the LOAEL.
(Ref. 9). In specific FQPA safety factor
decisions, the magnitude of the
response has frequently been an
important consideration supporting use
of a 3X FQPA safety factor to address
reliance on a LOAEL for the Point of
Departure. (See, e.g., 75 FR 22245,
22249, April 28, 2010 (selecting a 3X
FQPA safety factor for lack of a NOAEL
where [t]he neurotoxic effects in this
study showed a good dose response
which resulted in minimal effects on
motor activity and locomotor activity at
the LOAEL.); 74 FR 67090, 67094,
December 18, 2009 (selecting a 3X
FQPA safety factor for lack of a NOAEL
where [t]he gastric lesions (most
sensitive effect) are due to the direct
irritant properties of endothall (i.e.,
portal effects) and not as a result of
frank systemic toxicity; the severity of
the lesions were minimal to mild; and
there was no apparent dose-response for
this effect.); 74 FR 53172, 53177,
October 16, 2009 (The concern is low
for the use of a LOAEL to extrapolate a
NOAEL, given the relatively
insignificant nature of the effect
(transient diarrhea seen in the rat); the
fact that diarrhea was only seen in
studies involving gavage dosing in the
rat but not in repeat dosing through
dietary administration in rats, mice,
rabbits, and dogs; the very high dose
level needed to reach the acute oral
lethal dose (LD)
50
(>5,000 milligrams/
kilogram (mg/kg)), and the overall low
toxicity of azoxystrobin.); 74 FR 26536,
26541, June 3, 2009 (selecting a 3X
FQPA safety factor for lack of a NOAEL
where [t]he response was marginal at
the LOAEL.); 72 FR 41224, 41228, July
27, 2007 (The uncertainty factor of 3X
for use of the LOAEL instead of the
NOAEL is considered appropriate
because an increased incidence and
severity of epithelial hyperplasia,
hyperkeratosis and ulceration of the
non-glandular region of the stomach in
females were seen in few animals and
were minimal in severity and observed
in one sex only.); 72 FR 33901, 33905,
June 20, 2007 (The 3X factor is
considered to be protective because the
incidence of the effects at the lowest
dose tested was only marginally higher
than the historical controls.); 71 FR
71052, 71056, December 8, 2006 (A 3x
safety factor (as opposed to a 10x) for
the lack of a NOAEL in this critical
study is adequate because the
magnitude of the response was low (low
incidences without dose response) and
the effect of concern was seen in an
unusual strain (Chinchilla) of rabbits
and not in the New Zealand strain
commonly used in developmental
toxicity studies.)).
EPAs policy on cholinesterase
inhibition provides important guidance
on characterizing the magnitude of a
RBC cholinesterase finding. The policy
explains that cholinesterase activity
data is treated like most continuous
endpoints (i.e., graded measures of
response such as changes in organ
weight, hormone levels or enzyme
activity), in that no fixed generic
percentage of change from the baseline
is considered to separate adverse from
non-adverse effects. (Ref. 27 at 14).
Given the continuous nature of the
inhibition response, OPP has used
statistical significance, rather than a
fixed percentage of response from
baseline, as the primary, but not
exclusive, determinant of toxicological
and biological significance in selecting
Points of Departure. (Id.) Nonetheless,
the policy advises that, in examining
what level of cholinesterase inhibition
will be judged an adverse effect, the
level of inhibition must be critically
evaluated in the context of both
statistical and biological significance.
(Id. at 37) (emphasis in original).
Although the policy notes that [n]o
fixed percentage of change (e.g., 20% for
cholinesterase enzyme inhibition) is
predetermined to separate adverse from
non-adverse effects, (Id.), it explains
that OPPs experience with the review
of toxicity studies with cholinesterase-
inhibiting substances shows that
differences between pre- and post-
exposure of 20% or more in enzyme
levels is nearly always statistically
significant and would generally be
viewed as biologically significant. (Id.
at 3738). The policy recommends that
[t]he biological significance of
statistically-significant changes of less
than 20% would have to be judged on
a case-by-case basis, noting, in
particular the pattern of changes in the
enzyme levels and the presence or
absence of accompanying clinical signs
and/or symptoms. (Id. at 38). The
policy notes that similar or higher levels
of cholinesterase inhibition are used in
monitoring workers for occupational
exposures (even in the absence of signs,
symptoms, or other behavioral effects).
(Id. at 31). For example, the policy
points out that the California
Department of Health Services requires
that workers exposed to toxic chemicals
such as organophosphate pesticides be
removed from the workplace if red
blood cell cholinesterase levels show
30% or greater inhibition, and that the
World Health Organization has
guidelines with the same RBC action
levels (i.e., 30% or greater inhibition).
(Id.). In conducting Benchmark Dose
analyses for dichlorvos, as well as other
organophosphate pesticides, EPA
generally has used a 10 percent
inhibition level as indicating an adverse
effect for both RBC and brain
compartments given that both of these
compartments were used for developing
Points of Departure. (Ref. 37 at I.B p.17).
A close examination of the
cholinesterase inhibition data for
dichlorvos, however, has shown that,
while both brain and RBC
compartments have similar levels of
inhibition for acute or very short-term
exposures, for longer-term exposures
brain cholinesterase inhibition is much
less sensitive than RBC inhibition and
thus 20 percent RBC inhibition would
be adequately protective. (72 FR 68691;
Ref. 38). RBC cholinesterase inhibition
is not itself an adverse effect; rather, it
is used as a surrogate for effects on the
nervous system.
In the Gledhill study, the average
level of RBC cholinesterase inhibition of
the final day of treatment was 16
percent. Although the level of RBC
cholinesterase inhibition was relatively
low and not accompanied by clinical
signs, EPA concluded, contrary to the
studys author, that the 7 mg dose did
produce an adverse effect. In reaching
this conclusion, EPA relied on the
uniform nature of the results in the
subjects that showed a clear pattern of
increasing response over time and a
high level of statistical significance in
the differences in cholinesterase
inhibition both between treated and
control subjects and between pre-
treatment and post-treatment of
individual subjects. Nonetheless,
consistent with its cholinesterase policy
and its conclusions in regard to other
dichlorvos cholinesterase data, EPA
found the magnitude of the change in
cholinesterase levels to be marginal. The
Human Studies Review Board agreed
both with EPAs determination on
adversity and the marginality of the
response. As to the marginality of the
response, the Board specifically noted
that because the decreased activity in
RBC cholinesterase activity observed in
this study was at or near the limit of
what could be distinguished from
baseline values, it was unlikely that a
lower dose would produce a measurable
effect in RBC cholinesterase activity.
(Ref. 36 at 41). Under EPAs
cholinesterase policy, the level of
cholinesterase inhibition in the Gledhill
study falls at the low end of the scale
of what might be considered an adverse
effect and the policy recommends a
case-by-case inquiry into the adversity
determination for inhibition at this
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54418 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
3
The court stated that EPA had found the
Gledhill study to have had sufficient statistical
power to detect a cholinesterase inhibition greater
than 0, [but] EPA did not explain whether the 9-
person study (six dosed subjects, 3 placebo
subjects) had sufficient power to determine with
any level of precision the magnitude of the
cholinesterase inhibition. (Ref. at 218) (emphasis
added). To clarify, EPA did not do a statistical
power calculation because statistical power is a
way of determining the probability of whether a
study would detect an effect of a given size if such
an effect is there to find. The concern is that a study
may indicate that there is no effect when, in fact,
the study missed the effect because it had a low
probability of finding it (i.e., the study gives a false
negative). Because the Gledhill study identified the
positive effect it was looking for (cholinesterase
inhibition), EPA dismissed NRDCs arguments
regarding statistical power as irrelevant. (73 FR
4270442706). What EPAs statistical analysis of the
Gledhill study did show was that there was a
statistically significant difference (at the level of 1
percent) in cholinesterase inhibition between
control and treated subjects and between pre- and
post-dosing for treated subjects on most days of
treatment. That is, the differences in cholinesterase
inhibition between controlled and treated subjects
and between pre- and post-dosing of treated
subjects were very unlikely to have been due to
chance.
level. Accordingly, EPA determined
previously, and reaffirms in this order,
that a full 10X safety factor is not
needed to address the lack of a NOAEL
in the Gledhill study. When a full order
of magnitude of additional protection
(i.e. 10
1
) is unnecessary, EPA will
generally use a half of that value (i.e,
10
.5
or approximately 3X) if that value
is protective. Here, EPA determined,
and in this order reaffirms, that the
marginal nature of the cholinesterase
response shows that a 3X factor is safe.
In reaching its determination, EPA
placed, and continues to place, great
weight on the view of the Human
Studies Review Board. This Board was
created by EPA in response to a
congressional mandate. (71 FR 6138
(February 6, 2006)). It is comprised of
non-EPA scientists, overwhelmingly
from academia, who are specialists in
the field of bioethics, biostatistics,
human health risk assessment, and
human toxicology. (73 FR 42690). The
members of the Board at the time the
Gledhill study was considered are listed
in Appendix 1 to EPAs prior denial
order. (73 FR 42713). The Board is
charged with reviewing both the ethics
and scientific merit of intentional
exposure human studies. Its
proceedings are conducted in public
and it accepted three rounds of public
comment on review of the Gledhill
study: (1) Written comment submitted
prior to its open meeting on dichlorvos;
(2) oral comments at the open meeting;
and (3) oral comments at a telephone
conference on its proposed decision. (73
FR 42692). No comments were
submitted prior to the Boards review
suggesting that the cholinesterase
response was greater than a marginal
response and no meaningful comments
were submitted to the Board or EPA,
following release of the proposed and
final Board opinions, contesting the
conclusions of this independent and
expert scientific panel on this point.
The Boards conclusion with regard to
the marginality of the cholinesterase
inhibition effects in the Gledhill study
are strongly supportive of EPAs choice
of a 3X factor to address the lack of a
NOAEL in the Gledhill study. After all,
the Board concluded that it was
unlikely that a lower dose would
produce a measurable effect in RBC
cholinesterase activity. (Ref. 36 at 41).
Use of a 3X factor is protective because
it represents a choice of not simply of
any lower dose (decreasing the dose by
10 percent fits this criterion) but of a
significantly lower dose than that in the
Gledhill study for estimating risk (by
applying a 3X factor EPA was
essentially dividing the dose by a factor
of 3).
The court suggested in its opinion
that EPA had not conducted an
adequate statistical analysis to
determine the accuracy of the 16
percent cholinesterase inhibition figure
and thus had no basis for making a
conclusion with any level of precision
[as to] the magnitude of the
cholinesterase inhibition.
3
658 F.3d at
218. Although EPA scientists and the
scientists on the Human Studies Review
Board, including the three
biostatisticians, found the statistical
analysis sufficient to support their
conclusion on the marginality of the
cholinesterase effect, EPA agrees that a
precision analysis, i.e., the calculation
of confidence intervals, conveys
valuable information on the plausible
range in which, within a certain degree
of probability, the true value lies.
Accordingly, EPA has calculated the
confidence intervals for the mean
cholinesterase inhibition levels. (Ref.
39). For the days 14, 16, and 18 which
had average cholinesterase inhibition
levels of 14 percent, 14 percent, and 16
percent, respectively, this calculation
shows a 95 percent confidence that
average inhibition is between 9- and 18
percent, 9- and 19 percent, and 8- and
24 percent, respectively. Because these
ranges of RBC cholinesterase inhibition
consistently fall at the low end of what
might be found to be a statistically and
biologically significant effect on RBC
cholinesterase activity, EPA reaffirms its
conclusion that the RBC cholinesterase
inhibition seen in the Gledhill study
was marginal.
Finally, the determination to retain a
FQPA safety of 3X for assessments for
which the Point of Departure was
selected from the Gledhill study is also
supported by two BMD analyses on the
dose levels causing cholinesterase
inhibition in animals performed in
conjunction with the IRED. As
explained earlier, BMD analysis is
preferred by EPA to the NOAEL/LOAEL
approach of selecting a Point of
Departure from studies because all of
the data from a study can be used in
deriving a dose response curve. (Ref.
23). In the absence of the Gledhill study,
these analyses would substitute for the
LOAEL in the Gledhill study for
selection of the Point of Departure for
short- and intermediate-term risk
assessments because they define the
most sensitive effect for these exposure
durations. The first of these analyses is
a BMD analysis of comparative
cholinesterase studies conducted in
adult and juvenile rats. (This BMD
analysis is discussed in more detail
immediately below in the section on
pre- and post-natal toxicity.) The
lowest BMDL from that analysis
(focusing on pooled historical controls)
is 0.38 mg/kg/day. (Ref. 42). The second
BMD analysis is an analysis of the
cholinesterase inhibition results of the
subchronic toxicity rat study. (Ref. 40).
There, the BMDL was calculated as 0.4
mg/kg/day. The only other potential
animal study for use in selecting a Point
of Departure for short- and intermediate-
term exposures, the subchronic
neurotoxicity study, had a significantly
higher LOAEL (7.5 mg/kg/day) and
produced percentage inhibition levels
consistent with, or lower than, the other
animal cholinesterase studies. (Ref. 41).
A 100X safety factor to address
interspecies extrapolation and
interspecies variability would be used
with these BMDLs if they were chosen
as Points of Departure. No additional
FQPA factor would be needed for the
same reasons that a FQPA factor was not
applied to the other assessments relying
on animal data. (72 FR 6869468695).
Reliance on the BMD analyses for the
Point of Departure with a 100X safety
factor produces a level of concern that
is comparable to using the Gledhill
study for the Point of Departure with a
30X safety factor. This is most easily
seen if alternative RfD/PADs are
calculated using the BMD analyses from
the comparative cholinesterase studies
and the subchronic study and from the
LOAEL in the Gledhill study. With
Gledhill study, the LOAEL of 0.1 mg/kg/
day would be divided by 30 (10X for
intraspecies and 3X for FQPA) yielding
a RfD/PAD of 0.0033 mg/kg/day. With
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SPA-017
54419 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
the BMD analyses, the BMDL of 0.38
mg/kg/day or 0.4 mg/kg/day would be
divided by 100 (10x for interspecies and
10X for intraspecies) for a RfD/PAD of
0.0038 mg/kg/day or 0.004 mg/kg/day,
respectively. The similarity of these
results, whether extrapolating from the
animal or human data, provides extra
confidence in EPAs FQPA safety factor
decision. Additionally, EPA notes that
reliance of the Gledhill study produces
a marginally lower and thus more
protective level of concern.
Thus, the completeness of the toxicity
database consideration indicates that an
additional safety factor of no greater
than 3X is needed to protect the safety
of all populations, including infants and
children, due to a data deficiency in the
Gledhill study. This decision is
consistent with EPA policies on RfD
selection, the FQPA safety factor, and
cholinesterase inhibition, and with the
scientific literature on safety/
uncertainty factors. It is also consistent
with long-established practice in
making FQPA safety factor decisions in
circumstances where a LOAEL-to-
NOAEL extrapolation is necessary.
Finally, EPAs scientific conclusions
underlying this determination have
been concurred in by the Human
Studies Review Board, an independent
panel of scientific experts in the field of
toxicology and bio-statistics.
ii. Pre- and post-natal toxicity. There
was no evidence for increased
susceptibility of rat and rabbit offspring
to prenatal or postnatal exposure to
dichlorvos. In both rat and rabbit
developmental studies, no
developmental effects were observed. In
the rat reproduction study, the parental/
systemic NOAEL/LOAEL was 2.3/8.3
mg/kg/day, which was identical to the
reproductive/offspring NOAEL/LOAEL.
The developmental neurotoxicity study
showed evidence of sensitivity in one
parameter, auditory startle amplitude.
However, there are no residual concerns
for sensitivity from this parameter
because the effects in pups were seen at
a dose well above the Points of
Departure upon which EPA is regulating
and a clear NOAEL for the effect (again,
well above the Points of Departure) was
identified.
In addition, EPA evaluated the
relative sensitivity of adult and juvenile
animals to cholinesterase inhibition
from dichlorvos exposure using a
Benchmark Dose (BMD) analysis. For
dichlorvos, EPA did a BMD analysis of
the rodent toxicity studies for adult and
juvenile cholinesterase inhibition (in
both brain and RBC) in acute and
repeated dose scenarios. (Refs. 3 at 129;
42). EPA analyzed for a BMD showing
a 10 percent inhibition of
cholinesterase. EPA found similar
results for BMDs and BMDLs for
cholinesterase inhibition in both the
acute and repeated dose scenarios for
compartments (brain or RBC), sex, and
age. In other words, this analysis
indicated that there was no significant
sensitivity difference with regard to
cholinesterase inhibition between adults
and juveniles.
These data showing a lack of
sensitivity of juvenile animals relative
to adults indicate a low level of concern
that the intraspecies factor applied to
the Point of Departure from the Gledhill
study will fail to protect infants and
children. Therefore, the potential pre-
and post-natal toxicity consideration, by
itself, indicates that risks to infants and
children can be safely assessed absent
an additional safety factor.
iii. Completeness of the exposure
database. EPA has extensive data for
estimating human exposure levels to
dichlorvos. Although NRDC objected to
portions of EPAs dietary exposure
assessment, after a careful re-analysis of
that assessment EPA concluded that its
dichlorvos exposure estimate from food,
if anything, overstates dichlorvos
exposure given the many conservatisms
retained in the food exposure
assessment and dichlorvos documented
volatility and rapid degradation. (73 FR
42699; 72 FR 68686). Further, EPA
concluded that drinking water exposure
to dichlorvos was also likely to have
over-estimated exposure because of
conservative assumptions. (72 FR
6867968680). A similar conclusion was
reached as to residential exposure to
dichlorvos after EPA revised this
assessment taking into account concerns
raised by NRDC. (72 FR 68691). Thus,
the completeness of the exposure base
consideration, by itself, also does not
indicate a need for an additional safety
factor to protect infants and children.
3. Conclusion. The FQPA safety factor
provision requires EPA to
presumptively retain an additional 10X
safety factor for the protection of infants
and children. EPA may apply a different
factor only if reliable data show that
factor to be safe. Under EPA policy, EPA
considers whether the additional FQPA
safety factor is warranted taking into
account the other safety factors being
applied.
For the Gledhill-based risk
assessments, EPA has applied a 10X
intraspecies safety/uncertainty factor to
account for the potential for variable
sensitivity among humans. EPA has not
applied an interspecies factor in these
risk assessments because the Point of
Departure is drawn from a study in
humans, not laboratory animals. (See
Unit VII.B.2). Thus, the precise question
under the FQPA safety factor provision
for dichlorvos is whether EPA should
retain the presumptive additional 10X
factor for the protection of infants and
children or whether there are reliable
data showing that a different additional
factor will, in conjunction with the 10X
intraspecies factor, protect the safety of
infants and children. As the above
discussion of the all-important FQPA
safety factor considerations indicates,
there are (1) reliable data from animal
studies on adult/juvenile sensitivity
showing that the standard 10X
intraspecies factor will be protective of
potential pre- and post-natal toxicity to
infants and children; (2) reliable data on
human exposure to dichlorvos
demonstrating that an additional safety
factor is not needed to protect infants
and children due to exposure concerns;
and (3) reliable data with regard to the
one toxicity data deficiency identified to
show that a 3X additional factor will be
protective of all human populations,
including infants and children, as to the
only toxicity data completeness issue.
Therefore, EPA reaffirms its selection of
a 3X FQPA safety factor for Gledhill-
based assessments.
D. Conclusion
For all of the reasons set forth above,
EPA denies NRDCs objection to the use
of a 3X FQPA safety factor for
assessments relying on the Gledhill
study for a Point of Departure. Based on
the revised explanation provided in this
order, EPA concludes, like it did in the
July 23, 2008 order, that a 3X additional
safety factor will protect the safety of
infants and children. Because this
revised explanation addresses the
courts reason for finding portions of the
July 23, 2008 order to be arbitrary and
capricious, EPA has not otherwise
reopened or reconsidered that prior
order.
VIII. Statutory and Executive Order
Reviews
This action denies an objection to a
denial of a petition to revoke tolerances,
is in the form of an order and not a rule.
(21 U.S.C. 346a(g)(2)(C)). Under the
Administrative Procedure Act (APA),
orders are expressly excluded from the
definition of a rule. (5 U.S.C. 551(4)).
Accordingly, the regulatory assessment
requirements imposed on a rulemaking
do not apply to this action, as explained
further in the following discussion.
A. Executive Order 12866 and Executive
Order 13563
Because this order is not a regulatory
action as that term is defined in
Executive Order 12866 entitled
Regulatory Planning and Review (58
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SPA-018
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FR 51735, October 4, 1993), this action
is not subject to review by the Office of
Management and Budget (OMB) under
Executive Orders 12866 and 13563
entitled Improving Regulation and
Regulatory Review (76 FR 3821,
January 21, 2011).
B. Paperwork Reduction Act
This action does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq.
C. Regulatory Flexibility Act
Since this order is not a rule under
the APA (5 U.S.C. 551(4)), and does not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
D. Unfunded Mandates Reform Act; and
Executive Orders 13132 and 13175
This order denies an objection to a
denial of a petition to revoke tolerances;
it does not alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of section
408(n)(4) of FFDCA. As such, the
Agency has determined that this action
will not have a substantial direct effect
on States or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132 entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this order. In addition, this order does
not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
15311538).
E. Executive Orders 13045, 13211 and
12898
As indicated previously, this action is
not a regulatory action as defined by
Executive Order 12866. As a result, this
action is not subject to Executive Order
13045, entitled Protection of Children
from Environmental Health Risks and
Safety Risks, (62 FR 19885, April 23,
1997) and Executive Order 13211
entitled Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use,
(66 FR 28355, May 22, 2001). In
addition, this order also does not
require any special considerations
under Executive Order 12898 entitled
Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
F. National Technology Transfer and
Advancement Act
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA), (15 U.S.C. 272 note).
IX. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq. does not apply
because this action is not a rule as that
term is defined in 5 U.S.C. 804(3).
X. References
1. Natural Resources Defense Council.
(February 1, 2008). Objection to the Order
Denying NRDCs Petition to Revoke All
Tolerances for Dichlorvos (DDVP), and
Request for Public Evidentiary Hearing.
2. Natural Resources Defense Council.
(June 2, 2006). Petition of Natural Resources
Defense Council To Conclude Special
Review, Reregistration and Tolerance
Reassessment Processes and To Revoke All
Tolerances and Cancel All Registrations for
the Pesticide DDVP.
3. Office of Prevention, Pesticides and
Toxic Substances, EPA. (June 2006). Interim
Reregistration Eligibility Decision for
Dichlorvos (DDVP). Available from: http://
www.epa.gov/oppsrrd1/reregistration/REDs/
ddvp_ired.pdf.
4. Lu, F. and Sielken, R. (1991).
Assessment of safety/risk of chemicals:
inception and evolution of the ADI and dose-
response modeling procedures. Toxicology
Letters 59, 540.
5. Schueplein, R. (2002). Pesticides and
Infant Risk: Is There a Need for an Additional
Margin of Safety. Regulatory and
Toxicological Pharmacology. 31, 267279.
6. Lehman, A. and Fitzhugh, O. (1954).
Hundredfold margin of safety. Quarterly
Bulletin of the Association of Food and Drug
Officials of the United States. 3335.
7. Food and Agriculture Organization.
(1965). Evaluation of the toxicity of pesticide
residues in food. Joint report of the FAO
working party on pesticide residues and the
WHO Expert Committee on Pesticide
Residues FAO Meeting Report PL/1965/10/1,
WHO/Food Add./27.65, Rome. Stoner, H.
(1964). The Concept of acceptable Daily
Intakes of Pesticides for Man. Food and
Cosmetics Toxicology. 2, 457466.
8. International Programme on Chemical
Safety. (2005). Chemical-specific adjustment
Factors for Interspecies Differences and
Human Variability: Guidance Document for
use of DATA in Dose/Concentration-
Response Assessment. Available from: http://
whqlibdoc.who.int/publications/2005/
v9241546786_eng.pdf.
9. Dourson, M., Felter, S., and Robinson, D.
(1996). Evolution of Science-Based
Uncertainty Factors in Noncancer Risk
Assessment. Regulatory Toxicology and
Pharmacology. 24, 108120.
10. Office of Pesticide Programs, U.S. EPA,
Office of Pesticide Programs Policy on the
Determination of the Appropriate FQPA
Safety Factor(s) for Use in the Tolerance
Setting Process (February 28, 2002).
Available from: http://www.epa.gov/
oppfead1/trac/science/determ.pdf.
11. Barnes, D. and Dourson, M. (1988).
Reference Dose (RfD): Description and Use in
Health Risk Assessments. Regulatory
Toxicology and Pharmacology. 8, 471486.
12. National Research Council. (2009).
Science and Decisions: Advancing Risk
Assessment. (The National Academies Press).
13. Burin, G. and Saunders, D. (1999).
Addressing Human Variability in Risk
AssessmentThe Robustness of the
Intraspecies Uncertainty Factor. Regulatory
Toxicology and Pharmacology. 30, 209216.
14. Renwick, A. and Lazarus, N. (1998).
Human Variability and Noncancer Risk
AssessmentAn analysis of the Default
Uncertainty Factor. Regulatory Toxicology
and Pharmacology. 27, 320.
15. Dourson, M. and Stara, J. (1983).
Regulatory History and Experimental
Support of Uncertainty (Safety) Factors.
Regulatory Toxicology and Pharmacology. 3,
224238.
16. Renwick, A.G. (1991). Safety factors
and establishment of acceptable daily intake.
Food Additives & Contaminants. 8, 135150.
17. Dourson, M., Charnley, G., and
Scheuplein, R. (2002). Differential Sensitivity
of children and Adults to Chemical Toxicity.
Regulatory Toxicology and Pharmacology.
35, 448467.
18. National Research Council. (1993).
Pesticides in the Diets of Infants and
Children. (National Academy Press).
19. EPA. (2002). A review of the Reference
Dose and Reference Concentration Processes.
EPA/630/P02/002F.
20. U.S. EPA. (1994) Methods for
derivation of inhalation reference
concentrations and application of inhalation
dosimetry. EPA/600/890/066F.
21. U.S. EPA. (1999) Toxicology Data
Requirements For Assessing Risks Of
Pesticide Exposure To Childrens Health:
Report of the Toxicology Working Group of
the 10X Task Force [April 28, 1999 draft].
Available from: http://www.epa.gov/scipoly/
sap/meetings/1999/may/10xtx428.pdf.
22. Dourson, M., Knauf, L., and Swartout,
J. (1992). On Reference Dose (RfD) and its
underlying toxicity data base. Toxicology and
Industrial Health 8(3), 171189.
23. U.S. EPA. (2012). Benchmark Dose
Technical Guidance Document. EPA/100/R
12/001.
24. FIFRA Science Advisory Panel. (March
19, 2002). Methods Used to Conduct a
Preliminary Cumulative Risk Assessment for
Organophosphate Pesticides. Final Report
from the FIFRA Scientific Advisory Panel
Meeting of February 57, 2002 Available
from: http://www.epa.gov/scipoly/sap/
meetings/2002/february/final.pdf.
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SPA-019
54421 Federal Register / Vol. 77, No. 172/ Wednesday, September 5, 2012/ Rules and Regulations
25. FIFRA Science Advisory Panel. (April
15, 2005). Final report on N-Methyl
Carbamate Cumulative Risk Assessment:
Pilot Cumulative Analysis. Final Report from
the FIFRA Scientific Advisory Panel Meeting
of February 2005. Available from: http://
www.epa.gov/scipoly/sap/meetings/2005/
february/minutes.pdf.
26. FIFRA Science Advisory Panel.
(October 13, 2005). Final report on
Preliminary N-Methyl Carbamate Cumulative
Risk Assessment. Final Report from the
FIFRA Scientific Advisory Panel Meeting of
July 2930, 2005. Available from: http://
www.epa.gov/scipoly/sap/meetings/2005/
august/minutes.pdf.
27. Office of Pesticide Programs, U.S. EPA.
(2000). The Use of Data on Cholinesterase
Inhibition for Risk Assessments of
Organophosphorous and Carbamate
Pesticides. Available from: http://www.epa.
gov/oppfead1/trac/science/cholin.pdf.
28. Natural Resources Defense Council.
(July 30, 2010). Petitioners Brief, NRDC v.
U.S. EPA, No. 083771ag (2d Cir.).
29. U.S. EPA, Respondents Brief.
(November 18, 2010). NRDC v. U.S. EPA, No.
083771ag (2d Cir.).
30. Office of Chemical Safety and Pollution
Prevention, U.S. EPA. (August 8, 2012).
Memorandum from Ray Kent to Melanie
Biscoe, Lists of chemicals for which human
studies were either: Approved by the Human
Studies Review Board, or the basis for RfDs
or RfCs in IRIS.
31. Office of Prevention, Pesticides and
Toxic Substances, U.S. EPA. (June 15, 2006).
Report of the Food Quality Protection Act
(FQPA) Tolerance Reassessment and Risk
Management Decision (TRED) for Ethephon.
Available from: http://www.epa.gov/
oppsrrd1/REDs/ethephon_tred.pdf.
Regulatory Toxicology and Pharmacology.
32. Office of Prevention, Pesticides and
Toxic Substances. (June 19, 2007). U.S. EPA,
Memorandum from Feleica Fort to Tom
Myers, Methomyl. Acute, Probabilistic
Aggregate Dietary (Food and Drinking Water)
Exposure and Risk Assessments for the
Reregistration Eligibility Decision.
33. Office of Prevention, Pesticides and
Toxic Substances, U.S. EPA. (June 25, 2008).
Memorandum from Elissa Reaves and Anna
Lowit to Karen Santora, Mode of Action,
Eye Irritation, and the Intra-Species Factor:
Comparison of Chloropicrin and MITC.
34. Office of Pesticide Programs, U.S. EPA.
(March 24, 1998). Data Evaluation Report:
Dichlorvos: A Single Blind, Placebo
Controlled, Randomized Study to Investigate
the Effects of Multiple Oral Dosing on
Erythrocyte Cholinesterase Inhibition in
Healthy Male Volunteers.
35. Gledhill, A.J. (1997). Dichlorvos: A
Single Blind, Placebo controlled,
Randomised Study to Investigate the Effects
of Multiple Oral Dosing on Erythrocyte
Cholinesterase Inhibition in Healthy Male
Volunteers.
36. EPA Human Studies Review Board.
(May 15, 2006). Minutes of the United States
Environmental Protection Agency (EPA)
Human Studies Review Board (HSRB) April
46, 2006 Public Meeting.
37. Office of Pesticide Programs, U.S. EPA.
(June 2002). Revised Cumulative Risk
Assessment of the Organophosphorus
Pesticides. Available from: http://www.epa.
gov/pesticides/cumulative/rra-op/.
38. Office of Prevention, Pesticides and
Toxic Substances, U. S. EPA. (November 16,
2007). Memorandum from Ray Kent to Robert
McNally, Dichlorvos (PC 084001). Additional
characterization of inhalation risk posed by
use of dichlorvos-containing resin strips.
DP332823.
39. Office of Chemical Safety and Pollution
Prevention, U.S. EPA. (August 9, 2010).
Memorandum from Bayasid Sarkar to Ray
Kent, Precision analysis of Gledhill study for
litigation of DDVP.
40. Kent, R., Office of Pesticide Programs,
U.S. EPA. (April 5, 2006). Dichlorvos: WOE
Comparison of Human and Animal Studies
for Single Chemical Assessment and OP
Cumulative Assessment.
41. Office of Pesticide Programs, U.S. EPA.
(June 20, 1994). Memorandum from Brigid
Lowery to Jocelyn E. Steward, Dichlorvos
(DDVP). Review of Subchronic Neurotoxicity
Study in Sprague-Dawley Rats.
42. Office of Prevention, Pesticides and
Toxic Substances, U.S. EPA. (June 9, 2006).
Memorandum from Anna Lowit to Ray Kent,
Benchmark Dose analysis of cholinesterase
inhibition in neonatal and adult rats (MRID
no. 46688914) following exposure to DDVP.
43. National Research Council, Reference
Manual on Scientific Evidence 249252 (3rd
ed. 2011).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 29, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 201221844 Filed 9412; 8:45 am]
BILLING CODE 656050P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 101
[WT Docket No. 10153; RM11602; FCC
1287]
Facilitating the Use of Microwave for
Wireless Backhaul and Other Uses and
Providing Additional Flexibility To
Broadcast Auxiliary Service and
Operational Fixed Microwave
Licensees
AGENCY: Federal Communications
Commission.
ACTION: Final rule.
SUMMARY: In this document, the
Commission takes further steps to
remove regulatory barriers and lowering
costs for the wireless microwave
backhaul facilities that are an important
component of many mobile wireless
networks. The steps we take will
remove regulatory barriers that today
limit the use of spectrum for wireless
backhaul and other point-to-point and
point-to-multipoint communications.
This will also facilitate better use of
Fixed Service (FS) spectrum and
provide additional flexibility to enable
FS licensees to reduce operational costs
and facilitate the use of wireless
backhaul in rural areas. By enabling
more flexible and cost-effective
microwave services, the Commission
can help foster deployment of
broadband infrastructure across
America. In addition, a number of
parties sought reconsideration of the
Backhaul Report and Order, and we
address those requests and deny
reconsideration, for the most part.
DATES: Effective October 5, 2012.
The effective date for the Rural
Microwave Flexibility Policy, which
contains new or modified information
collection requirements has not been
approved by the Office of Management
and Budget (OMB). The Commission
will publish a document in the Federal
Register announcing the effective date
of that policy.
ADDRESSES: Federal Communications
Commission, 445 12th Street SW.,
Washington, DC 20554. A copy of any
comments on the Paperwork Reduction
Act information collection requirements
contained herein should be submitted to
Judith B. Herman, Federal
Communications Commission, Room 1
B441, 445 12th Street SW., Washington,
DC 20554 or via the Internet at Judith B.
Herman@fcc.gov.
FOR FURTHER INFORMATION CONTACT: John
Schauble, Wireless Telecommunications
Bureau, Broadband Division, at 202
4180797 or by email to
John.Schauble@fcc.gov. For additional
information concerning Paperwork
Reduction Act information collection
requirements contained in this
document, contact Judith B. Herman at
(202) 4180214, or via the Internet at
PRA@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commissions
document, FCC 1287, adopted and
released on August 3, 2012. The full text
of this document is available for
inspection and copying during normal
business hours in the FCC Reference
Information Center, Room CYA257,
445 12th Street SW., Washington, DC
20554. The complete text of the
Backhaul Second Report and Order,
Order on Reconsideration, and
Memorandum Opinion and Order
(Backhaul 2nd R&O, OOR, and MO&O)
and related Commission documents
may be purchased from the
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42683 Federal Register / Vol. 73, No. 142/ Wednesday, July 23, 2008/ Rules and Regulations
[FR Doc. E816833 Filed 72208; 8:45 am]
BILLING CODE 656050P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPAHQOPP20020302; FRL83725]
Dichlorvos (DDVP); Order Denying
NRDCs Objections and Requests for
Hearing
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final Order.
SUMMARY: In this order, EPA denies
objections to, and requests for hearing
on, a prior order denying a petition
requesting that EPA revoke all pesticide
tolerances for dichlorvos under section
408(d) of the Federal Food, Drug, and
Cosmetic Act. The objections and
hearing requests were filed on February
1, 2008, by the Natural Resources
Defense Council (NRDC). The
Original petition was also filed by
NRDC.
DATES: This order is effective July 23,
2008.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPAHQ
OPP20020302. To access the
electronic docket, go to http://
www.regulations.gov, and search for the
docket number. Follow the instructions
on the regulations.gov website to view
the docket index or access available
documents. All documents in the docket
are listed in the docket index available
in regulations.gov. Although listed in
the index, some information is not
publicly available, e.g., Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available in the electronic
docket at http://www.regulations.gov,
or, if only available in hard copy, at the
OPP Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305-
5805.
FOR FURTHER INFORMATION CONTACT:
Susan Bartow, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001;
telephone number: 703-603-0065; e-mail
address: bartow.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
In this document EPA denies
objections and hearing requests by the
Natural Resources Defense Council
(NRDC) concerning EPAs denial of
NRDCs petition to revoke pesticide
tolerances. This action may also be of
interest to agricultural producers, food
manufacturers, or pesticide
manufacturers. Potentially affected
entities may include, but are not limited
to those engaged in the following
activities:
Crop production (North American
Industrial Classification System
(NAICS) code 111), e.g., agricultural
workers; greenhouse, nursery, and
floriculture workers; farmers.
Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The NAICS codes have been
provided to assist you and others in
determining whether this action might
apply to certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at http://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the Federal Register listings at
http://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPAs tolerance
regulations at 40 CFR part 180 through
the Government Printing Offices pilot
e-CFR site at http://www.gpoaccess.gov/
ecfr.
C. Acronyms
The following is a list of acronyms
used in this order:
CSFII - Continuing Survey of Food Intakes by
Individuals
CNS - Central Nervous System
DDVP - dichlorvos
EDSTAC - Endocrine Disruptor Screening
and Testing Advisory Committee
EPA - Environmental Protection Agency
FACA - Federal Advisory Committee Act
FDA - Food and Drug Administration
FIFRA - Federal Insecticide, Fungicide, and
Rodenticide Act
FFDCA - Federal Food, Drug, and Cosmetic
Act
FQPA - Food Quality Protection Act of 1996
HSRB - Human Studies Review Board
IRED - Interim Reregistration Eligibility
Decision
LOAEL - Lowest Observed Adverse Effect
Level
MOE - Margin of Exposure
MRID - Master Record Identification
NOAEL - No Observed Adverse Effect Level
NRDC - Natural Resources Defense Council
OECD - Organisation for Economic Co-
operation and Development
PAD - Population Adjusted Dose
ppm - parts per million
RBC - red blood cell
RED - Reregistration Eligibility Decision
RfD - Reference Dose
SDWA - Safe Drinking Water Act
SOP - Standard Operating Procedure
USDA - United Stated Department of
Agriculture
II. Introduction
A. What Action Is the Agency Taking?
In this order, EPA denies objections,
and requests for a hearing on those
objections, to an earlier EPA order, (72
FR 68662 (December 5, 2007)), denying
a petition to revoke all tolerances
established for the pesticide dichlorvos
(DDVP) under the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C.
346a. (Refs. 1 and 2). Both the objections
and hearing requests, as well as the
petition, were filed with EPA by NRDC.
NRDCs petition, filed on June 2,
2006, pursuant to FFDCA section
408(d)(1), asserted numerous grounds as
to why the DDVP tolerances allegedly
fail to meet the FFDCAs safety
standard. This petition was filed as EPA
was completing its reassessment of the
safety of the DDVP tolerances pursuant
to FFDCA section 408(q). (Ref. 3). In
response to the petition, EPA undertook
an extensive review of its DDVP safety
evaluation in the tolerance reassessment
decision. Based on certain concerns
raised by NRDC, EPA determined it was
necessary to incorporate updated data
on numerous points and to adopt
revised and more conservative
assumptions, in its DDVP risk
assessments. This led to complete
revisions of both EPAs assessments of
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42684 Federal Register / Vol. 73, No. 142/ Wednesday, July 23, 2008/ Rules and Regulations
dietary and residential risks from
exposure to DDVP. (72 FR at 68678,
68687-68691). Nonetheless, EPA
concluded that its revised risk
assessments demonstrated that DDVP
met the FFDCA safety standard and,
therefore, denied the petition. (Id. at
68695). EPAs denial was issued in the
form of an order under FFDCA section
408(d)(4)(iii). (21 U.S.C. 346a(d)(4)(iii)).
NRDC then filed objections with EPA
to the petition denial order and
requested a hearing on its objections.
These objections and hearing requests
were filed pursuant to the procedures in
the FFDCA section 408(g)(2). (21 U.S.C.
346a(g)(2)). The objections narrowed
NRDCs claims to two main topics - that,
in assessing the risk to DDVP, EPA
unlawfully reduced the statutory safety
factor for the protection of infants and
children and EPA unlawfully relied on
a human toxicity study. As to these
claims, NRDC largely repeats the
arguments as presented in its petition
without addressing EPAs substantial
revisions to the DDVP risk assessment
and proffers little to no evidence in
support of its requests for a hearing.
After carefully reviewing the objections
and hearing requests, EPA has
determined that NRDCs hearing
requests do not satisfy the regulatory
requirements for such requests and that
its substantive objections are without
merit. Therefore, EPA, in this final
order, denies NRDCs objections and its
requests for a hearing on those
objections.
B. What Is the Agencys Authority for
Taking This Action?
NRDC petitioned to revoke the DDVP
tolerances pursuant to the petition
procedures in FFDCA section 408(d)(1).
(21 U.S.C. 346a(d)(1)). Under section
408(d), EPA may respond to such a
petition by either issuing a final or
proposed rule modifying or revoking the
tolerances or issuing an order denying
the petition. (21 U.S.C. 346a(d)(4)).
Here, EPA responded by issuing an
order under section 408(d)(4)(iii)
denying the petition. (72 FR 68622
(December 5, 2007)).
Orders issued under section
408(d)(4)(iii) are subject to a statutorily-
created administrative review process.
(21 U.S.C. 346a(g)(2)). Any person may
file objections to a section 408(d)(4)(iii)
order with EPA and request a hearing on
those objections. (Id.). EPA is required
by section 408(g)(2)(C) to issue a final
order resolving the objections to the
section 408(d)(4)(iii) order. (21 U.S.C.
346a(g)(2)(C)).
III. Statutory and Regulatory
Background
In this Unit, EPA provides
background on the relevant statutes and
regulations governing NRDCs
objections and requests for hearing as
well as on pertinent Agency policies
and practices. As noted, NRDCs
objections and requests for hearing raise
two main claims: (1) that EPA has
unlawfully failed to retain the full
tenfold safety factor for the protection of
infants and children; and (2) that it was
unlawful for EPA to rely on a toxicity
study for DDVP that was conducted
with humans. The childrens safety
factor claim is based on assertions
regarding DDVPs potential endocrine
effects and the adequacy of EPAs data
and risk assessments pertaining to
exposure to DDVP in food as a result of
the use of DDVP (and similar pesticides)
in agriculture or food storage and
through use of DDVP in residential
settings. The human studies claim
involves a challenge to the EPA
regulation governing reliance on human
studies as well as to EPAs application
of that rule to a particular human study.
The human study in question measured
cholinesterase inhibition in humans
resulting from administration of DDVP.
Background information on each of
these topics is included in this Unit.
Unit III.A. summarizes the
requirements and procedures in section
408 of the FFDCA and applicable
regulations pertaining to pesticide
tolerances, including the procedures for
petitioning for revocation of tolerances
and challenging the denial of such
petitions and the substantive standards
for evaluating the safety of pesticide
tolerances. This unit also discusses the
closely-related statute under which EPA
regulates the sale, distribution, and use
of pesticides, the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), (7 U.S.C. 136 et seq.).
Unit III.B. provides an overview of
EPAs risk assessment process. It
contains an explanation of how EPA
identifies the hazards posed by
pesticides, how EPA determines the
level of exposure to pesticides that pose
a concern (level of concern), how EPA
measures human exposure to pesticides,
and how hazard, level of concern
conclusions, and human exposure
estimates are combined to evaluate risk.
Further, this unit presents background
information on two Agency policies
with particular relevance to this action,
EPAs policy with regard to the statutory
safety factor for the protection of infants
and children and its policy with regard
to cholinesterase inhibition.
Unit III.C. summarizes EPAs program
for implementing the statutory
requirement to screen pesticides for
potential endocrine effects. Unit III.D.
describes the EPA regulation on use of
human studies.
A. FFDCA/FIFRA and Applicable
Regulations
1. In general. EPA establishes
maximum residue limits, or
tolerances, for pesticide residues in
food under section 408 of the FFDCA.
(21 U.S.C. 346a). Without such a
tolerance or an exemption from the
requirement of a tolerance, a food
containing a pesticide residue is
adulterated under section 402 of the
FFDCA and may not be legally moved
in interstate commerce. (21 U.S.C. 331,
342). Monitoring and enforcement of
pesticide tolerances are carried out by
the U.S. Food and Drug Administration
(FDA) and the U.S. Department of
Agriculture (USDA). Section 408 was
substantially rewritten by the Food
Quality Protection Act of 1996
(FQPA), which added the provisions
discussed below establishing a detailed
safety standard for pesticides, additional
protections for infants and children, and
the estrogenic substances screening
program. (Public Law 104-170, 110 Stat.
1489 (1996)).
EPA also regulates pesticides under
the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), (7 U.S.C.
136 et seq). While the FFDCA authorizes
the establishment of legal limits for
pesticide residues in food, FIFRA
requires the approval of pesticides prior
to their sale and distribution, (7 U.S.C.
136a(a)), and establishes a registration
regime for regulating the use of
pesticides. FIFRA regulates pesticide
use in conjunction with its registration
scheme by requiring EPA review and
approval of pesticide labels and
specifying that use of a pesticide
inconsistent with its label is a violation
of federal law. (7 U.S.C. 136j(a)(2)(G)).
In the FQPA, Congress integrated action
under the two statutes by requiring that
the safety standard under the FFDCA be
used as a criterion in FIFRA registration
actions as to pesticide uses which result
in dietary risk from residues in or on
food, (7 U.S.C. 136(bb)), and directing
that EPA coordinate, to the extent
practicable, revocations of tolerances
with pesticide cancellations under
FIFRA. (21 U.S.C. 346a(l)(1)).
2. Safety standard for pesticide
tolerances. A pesticide tolerance may
only be promulgated by EPA if the
tolerance is safe. (21 U.S.C.
346a(b)(2)(A)(i)). Safe is defined by
the statute to mean that there is a
reasonable certainty that no harm will
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result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information. (21 U.S.C.
346a(b)(2)(A)(ii)). Section 408(b)(2)(D)
directs EPA, in making a safety
determination, to:
consider, among other relevant
factors- ...
(v) available information concerning the
cumulative effects of such residues and other
substances that have a common mechanism
of toxicity;
(vi) available information concerning the
aggregate exposure levels of consumers (and
major identifiable subgroups of consumers)
to the pesticide chemical residue and to other
related substances, including dietary
exposure under the tolerance and all other
tolerances in effect for the pesticide chemical
residue, and exposure from other non-
occupational sources;
(viii) such information as the
Administrator may require on whether the
pesticide chemical may have an effect in
humans that is similar to an effect produced
by a naturally occurring estrogen or other
endocrine effects. ...
(21 U.S.C. 346a(b)(2)(D)(v), (vi) and
(viii)).
EPA must also consider, in evaluating
the safety of tolerances, safety factors
which . . . are generally recognized as
appropriate for the use of animal
experimentation data. (21 U.S.C.
346a(b)(2)(D)(ix).
Risks to infants and children are given
special consideration. Specifically,
section 408(b)(2)(C) states that EPA:
shall assess the risk of the pesticide
chemical based on ...
(II) available information concerning the
special susceptibility of infants and children
to the pesticide chemical residues, including
neurological differences between infants and
children and adults, and effects of in utero
exposure to pesticide chemicals; and
(III) available information concerning the
cumulative effects on infants and children of
such residues and other substances that have
a common mechanism of toxicity. ...
(21 U.S.C. 346a(b)(2)(C)(i)(II) and (III)).
This provision also creates a
presumptive additional safety factor for
the protection of infants and children.
Specifically, it directs that [i]n the case
of threshold effects, ... an additional
tenfold margin of safety for the pesticide
chemical residue and other sources of
exposure shall be applied for infants
and children to take into account
potential pre- and post-natal toxicity
and completeness of the data with
respect to exposure and toxicity to
infants and children. (21 U.S.C.
346a(b)(2)(C)). EPA is permitted to use
a different margin of safety for the
pesticide chemical residue only if, on
the basis of reliable data, such margin
will be safe for infants and children.
(Id.). The additional safety margin for
infants and children is referred to
throughout this order as the childrens
safety factor.
3. Procedures for establishing,
amending, or revoking tolerances.
Tolerances are established, amended, or
revoked by rulemaking under the
unique procedural framework set forth
in the FFDCA. Generally, a tolerance
rulemaking is initiated by the party
seeking to establish, amend, or revoke a
tolerance by means of filing a petition
with EPA. (See 21 U.S.C. 346a(d)(1)).
EPA publishes in the Federal Register a
notice of the petition filing and requests
public comment. (21 U.S.C. 346a(d)(3)).
After reviewing the petition, and any
comments received on it, EPA may issue
a final rule establishing, amending, or
revoking the tolerance, issue a proposed
rule to do the same, or deny the
petition. (21 U.S.C. 346a(d)(4)).
Once EPA takes final action on the
petition by either establishing,
amending, or revoking the tolerance or
denying the petition, any person may
file objections with EPA and seek an
evidentiary hearing on those objections.
(21 U.S.C. 346a(g)(2)). Objections and
hearing requests must be filed within 60
days. (Id.). The statute provides that
EPA shall hold a public evidentiary
hearing if and to the extent the
Administrator determines that such a
public hearing is necessary to receive
factual evidence relevant to material
issues of fact raised by the objections.
(21 U.S.C. 346a(g)(2)(B). EPA
regulations make clear that hearings will
only be granted where it is shown that
there is a genuine and substantial issue
of fact, the requestor has identified
evidence which, if established, resolve
one or more of such issues in favor of
the requestor, and the issue is
determinative with regard to the relief
requested. (40 CFR 178.32(b)). EPAs
final order on the objections is subject
to judicial review. (21 U.S.C.
346a(h)(1)).
4. Tolerance reassessment and FIFRA
reregistration. The FQPA required that
EPA reassess the safety of all pesticide
tolerances existing at the time of its
enactment. (21 U.S.C. 346a(q)). EPA was
given 10 years to reassess the
approximately 10,000 tolerances in
existence in 1996. In this reassessment,
EPA was required to review existing
pesticide tolerances under the new
reasonable certainty that no harm will
result standard set forth in section
408(b)(2)(A)(i). (21 U.S.C.
346a(b)(2)(A)(i)). This reassessment was
substantially completed by the August
3, 2006 deadline. Tolerance
reassessment was generally handled in
conjunction with a similar program
involving reregistration of pesticides
under FIFRA. (7 U.S.C. 136a-1).
Reassessment and reregistration
decisions were generally combined in a
document labeled a Reregistration
Eligibility Decision (RED).
5. Estrogenic substances screening
program. The FQPA also imposed
requirements regarding creation of an
estrogenic substances screening
program. Section 408(p) gives EPA 2
years from enactment of the FQPA to
develop a screening program ... to
determine whether [pesticide chemicals
and certain other substances] may have
an effect in humans that is similar to an
effect produced by a naturally occurring
estrogen, or such other endocrine effect
as the Administrator may designate.
(21 U.S.C. 346a(p)(1)). This screening
program must use appropriate
validated test systems and scientifically
relevant information. (Id.). Once the
program is developed, EPA is required
to take public comment and seek
independent scientific review of it.
Following the period for public
comment and scientific review, and not
later than 3 years following enactment
of the FQPA, EPA is directed to
implement the program. (21 U.S.C.
346a(p)(2)).
The scope of the estrogenic screening
program was expanded by an
amendment to the Safe Drinking Water
Act (SDWA) passed
contemporaneously with the FQPA.
That amendment gave EPA the authority
to provide for the testing, under the
FQPA estrogenic screening program, of
any other substance that may be found
in sources of drinking water if the
Administrator determines that a
substantial population may be exposed
to such substance. (42 U.S.C. 300j-17).
B. EPA Risk Assessment for
TolerancesPolicy and Practice
1. The safety determination - risk
assessment. To assess risk of a pesticide
tolerance, EPA combines information on
pesticide toxicity with information
regarding the route, magnitude, and
duration of exposure to the pesticide.
The risk assessment process involves
four distinct steps: (1) Identification of
the toxicological hazards posed by a
pesticide; (2) determination of the level
of concern with respect to human
exposure to the pesticide; (3) estimation
of human exposure to the pesticide; and
(4) characterization of risk posed to
humans by the pesticide based on
comparison of human exposure to the
level of concern.
a. Hazard identification. In evaluating
toxicity or hazard, EPA reviews toxicity
studies, primarily in laboratory animals,
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to identify any adverse effects on the
test subjects. Animal studies typically
involve investigating a broad range of
endpoints including gross and
microscopic effects on organs and
tissues, functional effects on bodily
organs and systems, effects on blood
parameters (such as red blood cell
count, hemoglobin concentration,
hematocrit, and a measure of clotting
potential), effects on the concentrations
of normal blood chemicals (including
glucose, total cholesterol, urea nitrogen,
creatinine, total protein, total bilirubin,
albumin, hormones, and enzymes such
as alkaline phosphatase, alanine
aminotransfersase and cholinesterases),
and behavioral or other gross effects
identified through clinical observation
and measurement. EPA examines
whether adverse effects are caused by
either short-term (e.g., acute) or
longer-term (e.g., chronic) pesticide
exposure and the effects of pre-natal and
post-natal exposure in animals.
EPA also considers whether the
adverse effect has a threshold - a level
below which exposure has no
appreciable chance of causing the
adverse effect. For non-threshold effects,
EPA assumes that any exposure to the
substance increases the risk that the
adverse effect may occur. At present,
EPA only considers one adverse effect,
the chronic effect of cancer, to
potentially be a non-threshold effect.
(Ref. 4 at 8-9). Not all carcinogens,
however, pose a risk at any exposure
level (i.e., a non-threshold effect or
risk). Advances in the understanding
of the mode of action of carcinogenesis
have increasingly led EPA to conclude
that some pesticides that cause
carcinogenic effects in animal studies
only cause such effects above a certain
threshold of exposure. EPA has
traditionally considered non-cancer
adverse effects on the endocrine system
to be threshold effects; that
determination is being reexamined in
conjunction with the endocrine
disruptor screening program.
b. Level of concern/dose-response
analysis. Once a pesticides potential
hazards are identified, EPA determines
a toxicological level of concern for
evaluating the risk posed by human
exposure to the pesticide. In this step of
the risk assessment process, EPA
essentially evaluates the levels of
exposure to the pesticide at which
effects might occur. An important aspect
of this determination is assessing the
relationship between exposure (dose)
and response (often referred to as the
dose-response analysis). EPA follows
differing approaches to identifying a
level of concern for threshold and non-
threshold hazards.
i. Threshold effects. In examining the
dose-response relationship for a
pesticides threshold effects, EPA
evaluates an array of toxicity studies on
the pesticide. In each of these studies,
EPA attempts to identify the lowest
observed adverse effect level (LOAEL)
and the next lower dose at which there
are no observed adverse affect levels
(NOAEL). Generally, EPA will use the
lowest NOAEL from the available
studies as a starting point (called the
Point of Departure) in estimating the
level of concern for humans. (Ref. 4 at
9 (The Point of Departure is simply the
toxic dose that serves as the starting
point in extrapolating a risk to the
human population.)). At times,
however, EPA will use a LOAEL from a
study as the Point of Departure when no
NOAEL is identified in that study and
the LOAEL is close to, or lower than,
other relevant NOAELs. The Point of
Departure is in turn used in choosing a
level of concern. EPA will make
separate determinations as to the Points
of Departure, and correspondingly
levels of concern, for both short and
long exposure periods as well as for the
different routes of exposure (oral,
dermal, and inhalation).
In estimating and describing the level
of concern, the Point of Departure is at
times used differently depending on
whether the risk assessment addresses
dietary or non-dietary exposures. For
dietary risks, EPA uses the Point of
Departure to calculate an acceptable
level of exposure or reference dose
(RfD). The RfD is calculated by
dividing the Point of Departure by all
applicable safety or uncertainty factors.
Typically, EPA uses a baseline safety/
uncertainty factor equal to 100. That
value includes a factor of ten (10X)
where EPA is using data from laboratory
animals to reflect potentially greater
sensitivity in humans than animals and
a factor of 10X to account for potential
variations in sensitivity among members
of the human population as well as
other unknowns. Additional safety
factors may be added to address data
deficiencies or concerns raised by the
existing data. Under the FQPA, an
additional safety factor of 10X is
presumptively applied to protect infants
and children, unless reliable data
support selection of a different factor.
This FQPA additional safety factor
largely replaces pre-FQPA EPA practice
regarding additional safety factors. (Ref.
5 at 4-11).
In implementing FFDCA section 408,
EPAs Office of Pesticide Programs, also
calculates a variant of the RfD referred
to as a Population Adjusted Dose
(PAD). A PAD is the RfD divided by
any portion of the FQPA safety factor
that does not correspond to one of the
traditional additional safety factors used
in general Agency risk assessments.
(Ref. 5 at 13-16). The reason for
calculating PADs is so that other parts
of the Agency, which are not governed
by FFDCA section 408, can, when
evaluating the same or similar
substances, easily identify which
aspects of a pesticide risk assessment
are a function of the particular statutory
commands in FFDCA section 408.
Today, RfDs and PADs are generally
calculated for both acute and chronic
dietary risks although traditionally a
RfD or PAD was only calculated for
chronic dietary risks. Throughout this
document general references to EPAs
calculated safe dose are denoted as a
RfD/PAD.
For non-dietary, and combined
dietary and non-dietary, risk
assessments of threshold effects, the
toxicological level of concern is not
expressed as a RfD/PAD but rather in
terms of an acceptable (or target)
margin of exposure (MOE) between
human exposure and the Point of
Departure. The margin of interest is
the ratio between human exposure and
the Point of Departure which is
calculated by dividing human exposure
into the Point of Departure. An
acceptable MOE is generally considered
to be a margin at least as high as the
product of all applicable safety factors
for a pesticide. For example, if a
pesticide needs a 10X factor to account
for inter-species differences, 10X factor
for intra-species differences, and 10X
factor for the FQPA childrens safety
provision, the safe or target MOE would
be a MOE of at least 1,000. What that
means is that for the pesticide to meet
the safety standard, human exposure to
the pesticide would have to be at least
1,000 times smaller than the Point of
Departure. Like RfD/PADs, specific
target MOEs are selected for exposures
of different durations. For non-dietary
exposures, EPA typically examines
short-term, intermediate-term, and long-
term exposures. Additionally, target
MOEs may be selected based on both
the duration of exposure and the various
routes of non-dietary exposure - dermal,
inhalation, and oral.
ii. Non-threshold effects. For risk
assessments for non-threshold effects,
EPA does not use the RfD/PAD or MOE
approach to choose a level of concern if
quantification of the risk is deemed
appropriate. Rather, EPA calculates the
slope of the dose-response curve for the
non-threshold effects from relevant
studies using a linear, low-dose
extrapolation model that assumes that
any amount of exposure will lead to
some degree of risk. This dose-response
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analysis will be used in the risk
characterization stage to estimate the
risk to humans of the non-threshold
effect. Linear, low-dose extrapolation is
typically used as the default approach
for estimating the risk to carcinogens,
unless there are mode of action data
indicating a threshold response (or
nonlinearity).
c. Estimating human exposure. Risk is
a function of both hazard and exposure.
Thus, equally important to the risk
assessment process as determining the
hazards posed by a pesticide and the
toxicological level of concern for those
hazards is estimating human exposure.
Under FFDCA section 408, EPA is
concerned not only with exposure to
pesticide residues in food but also
exposure resulting from pesticide
contamination of drinking water
supplies and from use of pesticides in
the home or other non-occupational
settings. (See 21 U.S.C.
346a(b)(2)(D)(vi)).
i. Exposure from food. There are two
critical variables in estimating exposure
in food: (1) The types and amount of
food that is consumed; and (2) the
residue level in that food. Consumption
is estimated by EPA based on scientific
surveys of individuals food
consumption in the United States
conducted by the USDA. (Ref. 4 at 12).
Information on residue values comes
from a range of sources including crop
field trials, data on pesticide reduction
(or concentration) due to processing,
cooking, and other practices,
information on the extent of usage of the
pesticide, and monitoring of the food
supply. (Id. at 17).
In assessing exposure from pesticide
residues in food, EPA, for efficiencys
sake, follows a tiered approach in which
it, in the first instance, assesses
exposure using the worst case
assumptions that 100 percent of the
crop in question is treated with the
pesticide and 100 percent of the food
from that crop contains pesticide
residues at the tolerance level. (Id. at
11). When such an assessment shows no
risks of concern, a more complex risk
assessment is unnecessary. By avoiding
a more complex risk assessment, EPAs
resources are conserved and regulated
parties are spared the cost of any
additional studies that may be needed.
If, however, a first tier assessment
suggests there could be a risk of
concern, EPA then attempts to refine its
exposure assumptions to yield a more
realistic picture of residue values
through use of data on the percent of the
crop actually treated with the pesticide
and data on the level of residues that
may be present on the treated crop.
These latter data are used to estimate
what has been traditionally referred to
by EPA as anticipated residues.
Use of percent crop treated data and
anticipated residue information is
appropriate because EPAs worst-case
assumptions of 100 percent treatment
and residues at tolerance value
significantly overstate residue values.
There are several reasons this is true.
First, all growers of a particular crop
would rarely choose to apply the same
pesticide to that crop; generally, the
proportion of the crop treated with a
particular pesticide is significantly
below 100 percent. (70 FR 46706, 46731
(August 10, 2005)). Second, the
tolerance value represents a high end or
worst case value. Tolerance values are
chosen only after EPA has evaluated
data from experimental crop field trials
in which the pesticide has been used in
a manner, consistent with the draft
FIFRA label, that is likely to produce
the highest residue in the crop in
question (e.g., maximum application
rate, maximum number of applications,
minimum pre-harvest interval between
last pesticide application and harvest).
(Refs. 4 and 6). These crop field trials
are generally conducted in several fields
at several geographical locations. (Id. at
5, 7 and Tables 1 and 5). Several
samples are then gathered from each
field and analyzed. (Id. at 53).
Generally, the results from such field
trials show that the residue levels for a
given pesticide use will vary from as
low as non-detectable to measurable
values in the parts per million (ppm)
range with the majority of the values
falling at the lower part of the range. (70
FR at 46731). EPA uses a statistical
procedure to analyze the field trial
results and identify the upper bound of
expected residue values. This upper
bound value is used as the tolerance
value. (Ref. 7). There may be some
commodities from a treated crop that
approach the tolerance value where the
maximum label rates are followed, but
most generally fall significantly below
the tolerance value. If less than the
maximum legal rate is applied, residues
will be even lower. Third, residue
values in the field do not take into
account the lowering of residue values
that frequently occurs as a result of
degradation over time and through food
processing and cooking.
EPA uses several techniques to refine
residue value estimates. (Ref. 4 at 17-
28). First, where appropriate, EPA will
take into account all the residue values
reported in the crop field trials, either
through use of an average or
individually. Second, EPA will consider
data showing what portion of the crop
is not treated with the pesticide. Third,
data can be produced showing pesticide
degradation and decline over time, and
the effect of commercial and consumer
food handling and processing practices.
Finally, EPA can consult monitoring
data gathered by the FDA, the USDA, or
pesticide registrants, on pesticide levels
in food at points in the food distribution
chain distant from the farm, including
retail food establishments.
Another critical component of the
exposure assessment is how data on
consumption patterns are combined
with data on pesticide residue levels in
food. Traditionally, EPA has calculated
exposure by simply multiplying average
consumption by average residue values
for estimating chronic risks and high-
end consumption by maximum residue
values for estimating acute risks. Using
average residues is a realistic approach
for chronic risk assessment due to the
fact that variations in residue levels and
consumption amounts average out over
time. Using average values is
inappropriate for acute risk assessments,
however, because in assessing acute
exposure situations it matters how
much of each treated food a given
consumer eats and what the residue
levels are in the particular foods
consumed. Yet, using maximum residue
values for acute risk assessment tends to
greatly overstate exposure because it is
unlikely that a person would consume
at a single meal multiple food
components bearing high-end residues.
To take into account the variations in
short-term consumption patterns and
food residue values for acute risk
assessments, EPA has more recently
begun using probabilistic modeling
techniques for estimating exposure
when more simplistic models appear to
show risks of concerns.
All of these refinements to the
exposure assessment process, from use
of food monitoring data through
probabilistic modeling, can have
dramatic effects on the level of exposure
predicted, reducing worst case estimates
by 1 or 2 orders of magnitude or more.
(Ref. 8 at 16-17; 70 FR 46706, 46732
(August 10, 2005).
ii. Exposure from water. EPA may use
either or both field monitoring data and
mathematical water exposure models to
generate pesticide exposure estimates in
drinking water. Monitoring and
modeling are both important tools for
estimating pesticide concentrations in
water and can provide different types of
information. Monitoring data can
provide estimates of pesticide
concentrations in water that are
representative of specific agricultural or
residential pesticide practices and
under environmental conditions
associated with a sampling design.
Although monitoring data can provide a
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direct measure of the concentration of a
pesticide in water, it does not always
provide a reliable estimate of exposure
because sampling may not occur in
areas with the highest pesticide use,
and/or the sampling may not occur
when the pesticides are being used.
In estimating pesticide exposure
levels in drinking water, EPA most
frequently uses mathematical water
exposure models. EPAs models are
based on extensive monitoring data and
detailed information on soil properties,
crop characteristics, and weather
patterns. (69 FR 30042, 30058-30065
(May 26, 2004)). These models calculate
estimated environmental concentrations
of pesticides using laboratory data that
describe how fast the pesticide breaks
down to other chemicals and how it
moves in the environment. These
concentrations can be estimated
continuously over long periods of time,
and for places that are of most interest
for any particular pesticide. Modeling is
a useful tool for characterizing
vulnerable sites, and can be used to
estimate peak concentrations from
infrequent, large storms.
iii. Residential exposures. Generally,
in assessing residential exposure to
pesticides EPA relies on its Residential
Standard Operating Procedures
(SOPs). (Ref. 9). The SOPs establish
models for estimating application and
post-application exposures in a
residential setting where pesticide-
specific monitoring data are not
available. SOPs have been developed for
many common exposure scenarios
including pesticide treatment of lawns,
garden plants, trees, swimming pools,
pets, and indoor surfaces including
crack and crevice treatments. The SOPs
are based on existing monitoring and
survey data including information on
activity patterns, particularly for
children. Where available, EPA relies on
pesticide-specific data in estimating
residential exposures.
d. Risk characterization. The final
step in the risk assessment is risk
characterization. In this step, EPA
combines information from the first
three steps (hazard identification, level
of concern/dose-response analysis, and
human exposure assessment) to
quantitatively estimate the risks posed
by a pesticide. Separate
characterizations of risk are conducted
for different durations of exposure.
Additionally, separate and, where
appropriate, aggregate characterizations
or risk are conducted for the different
routes of exposure (dietary and non-
dietary).
For threshold risks, EPA estimates
risk in one of two ways. Where EPA has
calculated a RfD/PAD, risk is estimated
by expressing human exposure as a
percentage of the RfD/PAD. Exposures
lower than 100 percent of the RfD/PAD
are generally not of concern.
Alternatively, EPA may express risk by
comparing the MOE between estimated
human exposure and the Point of
Departure with the acceptable or target
MOE. As described above, the
acceptable or target MOE is the product
of all applicable safety factors. To
calculate the actual MOE for a pesticide,
estimated human exposure to the
pesticide is divided into the Point of
Departure. In contrast to the RfD/PAD
approach, the higher the MOE, the safer
the pesticide. Accordingly, if the target
MOE for a pesticide is 100, MOEs equal
to or exceeding 100 would generally not
be of concern.
As a conceptual matter, the RfD/PAD
and MOE approaches are fundamentally
equivalent. For a given risk and given
exposure of a pesticide, if exposure to
a pesticide were found to be acceptable
under an RfD/PAD analysis it would
also pass under the MOE approach, and
vice-versa. However, for any specific
pesticide, risk assessments for different
exposure durations or routes may yield
different results. This is a function not
of the choice of the RfD/PAD or MOE
approach but of the fact that the levels
of concern and the levels of exposure
may differ depending on the duration
and route of exposure.
For non-threshold risks (generally,
cancer risks), EPA uses the slope of the
dose-response curve for a pesticide in
conjunction with an estimation of
human exposure to that pesticide to
estimate the probability of occurrence of
additional adverse effects. For non-
threshold cancer risks, EPA generally
considers cancer risk to be negligible if
the probability of increased cancer cases
falls within the range of 1 in 1 million.
Risks exceeding values within that
range would raise a risk concern.
2. EPA policy on the childrens safety
factor. As the above brief summary of
EPAs risk assessment practice
indicates, the use of safety factors plays
a critical role in the process. This is true
for traditional 10X safety factors to
account for potential differences
between animals and humans when
relying on studies in animals (inter-
species safety factor) and potential
differences among humans (intra-
species safety factor) as well as the
FQPAs additional 10X childrens safety
factor.
In applying the childrens safety
factor provision, EPA has interpreted it
as imposing a presumption in favor of
applying an additional 10X safety factor.
(Ref. 5 at 4, 11). Thus, EPA generally
refers to the additional 10X factor as a
presumptive or default 10X factor. EPA
has also made clear, however, that this
presumption or default in favor of the
additional 10X is only a presumption.
The presumption can be overcome if
reliable data demonstrate that a different
factor is safe for children. (Id.). In
determining whether a different factor is
safe for children, EPA focuses on the
three factors listed in section
408(b)(2)(C) - the completeness of the
toxicity database, the completeness of
the exposure database, and potential
pre- and post-natal toxicity. In
examining these factors, EPA strives to
make sure that its choice of a safety
factor, based on a weight-of-the-
evidence evaluation, does not
understate the risk to children. (Id. at
24-25, 35).
3. EPA policy on cholinesterase
inhibition as a regulatory endpoint.
Cholinesterase inhibition is a disruption
of the normal process in the body by
which the nervous system chemically
communicates with muscles and glands.
Communication between nerve cells
and a target cell (i.e., another nerve cell,
a muscle fiber, or a gland) is facilitated
by the chemical, acetylcholine. When a
nerve cell is stimulated it releases
acetylcholine into the synapse (or space)
between the nerve cell and the target
cell. The released acetylcholine binds to
receptors in the target cell, stimulating
the target cell in turn. As EPA has
explained, the end result of the
stimulation of cholinergic pathway(s)
includes, for example, the contraction of
smooth (e.g., in the gastrointestinal
tract) or skeletal muscle, changes in
heart rate or glandular secretion (e.g.,
sweat glands) or communication
between nerve cells in the brain or in
the autonomic ganglia of the peripheral
nervous system. (Ref. 10 at 10).
Acetylcholinesterase is an enzyme
that breaks down acetylcholine and
terminates its stimulating action in the
synapse between nerve cells and target
cells. When acetylcholinesterase is
inhibited, acetylcholine builds up
prolonging the stimulation of the target
cell. This excessive stimulation
potentially results in a broad range of
adverse effects on many bodily
functions including muscle cramping or
paralysis, excessive glandular
secretions, or effects on learning,
memory, or other behavioral parameters.
Depending on the degree of inhibition
these effects can be serious, even fatal.
EPAs cholinesterase inhibition policy
statement explains EPAs approach to
evaluating the risks posed by
cholinesterase-inhibiting pesticides
such as DDVP. (Ref. 10). The policy
focuses on three types of effects
associated with cholinesterase-
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inhibiting pesticides that may be
assessed in animal and human
toxicological studies: (1) Physiological
and behavioral/functional effects; (2)
cholinesterase inhibition in the central
and peripheral nervous system; and (3)
cholinesterase inhibition in red blood
cells and blood plasma. The policy
discusses how such data should be
integrated in deriving an acceptable
dose (RfD/PAD) for a cholinesterase-
inhibiting pesticide.
Clinical signs or symptoms of
cholinesterase inhibition in humans, the
policy concludes, provide the most
direct evidence of the adverse
consequences of exposure to
cholinesterase-inhibiting pesticides.
Nonetheless, as the policy notes, due to
strict ethical limitations, studies in
humans are quite limited. (Id. at 19).
Although animal studies can also
provide direct evidence of
cholinesterase inhibition effects, animal
studies cannot easily measure cognitive
effects of cholinesterase inhibition such
as effects on perception, learning, and
memory. For these reasons, the policy
recommends that functional data
obtained from human and animal
studies should not be relied on solely,
to the exclusion of other kinds of
pertinent information, when weighing
the evidence for selection of the critical
effect(s) that will be used as the basis of
the RfD or RfC. (Id. at 20).
After clinical signs or symptoms,
cholinesterase inhibition in the nervous
system provides the next most
important endpoint for evaluating
cholinesterase-inhibiting pesticides.
Although cholinesterase inhibition in
the nervous system is not itself regarded
as a direct adverse effect, it is generally
accepted as a key component of the
mechanism of toxicity leading to
adverse cholinergic effects. (Id. at 25).
As such, the policy states that it should
be treated as direct evidence of
potential adverse effects and data
showing this response provide valuable
information in assessing potential
hazards posed by anticholinesterase
pesticides. (Id.). Unfortunately, useful
data measuring cholinesterase
inhibition in the central and peripheral
nervous systems has only been
relatively rarely captured by standard
toxicology testing, particularly as to
peripheral nervous system effects. For
central nervous system effects, however,
more recent neurotoxicity studies have
sought to characterize the time course of
inhibition in ... [the] brain, including
brain regions, after acute and 90day
exposures. (Id. at 27).
Cholinesterase inhibition in the blood
is one step further removed from the
direct harmful consequences of
cholinesterase-inhibiting pesticides.
According to the policy, inhibition of
blood cholinesterases is not an adverse
effect, but may indicate a potential for
adverse effects on the nervous system.
(Id. at 28). The policy states that [a]s
a matter of science policy, blood
cholinesterase data are considered
appropriate surrogate measures of
potential effects on peripheral nervous
system acetylcholinesterase activity in
animals, for central nervous system
(CNS) acetylcholinesterase activity in
animals when CNS data are lacking and
for both peripheral and central nervous
system acetylcholinesterase in
humans. (Id. at 29). The policy notes
that there is often a direct relationship
between a greater magnitude of
exposure [to a cholinesterase-inhibiting
pesticide] and an increase in incidence
and severity of clinical signs and
symptoms as well as blood
cholinesterase inhibition. (Id. at 30).
Thus, the policy regards blood
cholinesterase data as appropriate
endpoints for derivation of reference
doses or concentrations when
considered in a weight-of-the-evidence
analysis of the entire database .... (Id.
at 29). Between cholinesterase
inhibition measured in red blood cell
(RBC) or blood plasma, the policy
states a preference for reliance on RBC
acetylcholinesterase measurements
because plasma is composed of a
mixture of acetylcholinesterase and
butyrylcholinesterase, and inhibition of
the latter is less clearly tied to inhibition
of acetylcholinesterase in the nervous
system. (Id. at 29, 32).
If a measure of cholinesterase
inhibition (e.g., RBC cholinesterase) is
being considered as a potential adverse
effect or surrogate for an adverse effect,
the policy advises that the level of
inhibition must be critically evaluated
in the context of both statistical and
biological significance. (Id. at 37)
(emphasis in Original). The policy notes
that [n]o fixed percentage of change
(e.g., 20% for cholinesterase enzyme
inhibition) is predetermined to separate
adverse from non-adverse effects. (Id.).
Rather, the policy explains that OPPs
experience with the review of toxicity
studies with cholinesterase-inhibiting
substances shows that differences
between pre- and post-exposure of 20%
or more in enzyme levels is nearly
always statistically significant and
would generally be viewed as
biologically significant. (Id. at 37-38).
The policy recommends that [t]he
biological significance of statistically-
significant changes of less than 20%
would have to be judged on a case-by-
case basis, noting, in particular the
pattern of changes in the enzyme levels
and the presence or absence of
accompanying clinical signs and/or
symptoms. (Id. at 38). The policy notes
that similar or higher levels of
cholinesterase inhibition are used in
monitoring workers for occupational
exposures (even in the absence of signs,
symptoms, or other behavioral effects).
(Id. at 31). For example, the policy
points out that the California
Department of Health Services requires
that workers exposed to toxic chemicals
such as organophosphate pesticides be
removed from the workplace if red
blood cell cholinesterase levels show
30% or greater inhibition, and that the
World Health Organization has
guidelines with the same RBC action
levels (i.e., 30% or greater inhibition).
(Id.).
C. Endocrine Disruptor Screening
Program
The 1996 FQPA and SWDA
amendments directed EPA to develop
and implement an endocrine screening
program. To aid in the design of this
program called for in the FQPA and
SDWA amendments, EPA created the
Endocrine Disruptor Screening and
Testing Advisory Committee
(EDSTAC), which was comprised of
members representing the commercial
chemical and pesticides industries,
federal and state agencies, worker
protection and labor organizations,
environmental and public health
groups, and research scientists. (63 FR
71542, 71544, Dec. 28, 1998). The
EDSTAC presented a comprehensive
report in August 1998 addressing both
the scope and elements of the endocrine
screening program. (Ref. 11). The
EDSTACs recommendations were
largely adopted by EPA.
As recommended by EDSTAC, EPA
expanded the scope of the program from
focusing only on estrogenic effects to
include other effects on the endocrine
system (i.e., androgenic and thyroid
effects). (63 FR at 71545). Further, EPA,
again on the EDSTACs
recommendation, chose to include both
human and ecological effects in the
program. (Id.). Finally, based on
EDSTACs recommendation, EPA
established the universe of chemicals to
be screened to include not just
pesticides but also a wide range of other
chemical substances. (Id.). As to the
program elements, EPA adopted
EDSTACs recommended two-tier
approach with the first tier involving
screening to identify substances that
have the potential to interact with the
endocrine system and the second tier
involving testing to determine whether
the substance causes adverse effects,
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identify the adverse effects caused by
the substance, and establish a
quantitative relationship between the
dose and the adverse effect. (Id.). Tier
1 screening is limited to evaluating
whether a substance is capable of
interacting with the endocrine system,
and is not sufficient to determine
whether a chemical substance may have
an effect in humans that is similar to an
effect produced by naturally occurring
hormones. (Id. at 71550). Based on the
results of Tier 1 screening, EPA will
decide whether Tier 2 testing is needed.
Importantly, [t]he outcome of Tier 2 is
designed to be conclusive in relation to
the outcome of Tier 1 and any other
prior information. Thus, a negative
outcome in Tier 2 will supersede a
positive outcome in Tier 1. (Id. at
71554-71555).
The EDSTAC provided detailed
recommendations for Tier 1 screening
and Tier 2 testing. The panel of the
EDSTAC that devised these
recommendations was comprised of
distinguished scientists from academia,
government, industry, and the
environmental community. (Ref. 11 at
Appendix B). As suggested by the
EDSTAC, EPA has proposed a battery of
short-term in vitro and in vivo assays for
the Tier 1 screening exercise. (63 FR at
71550-71551). Validation of all but one
of these assays is complete. As to Tier
2 testing, EPA, on the recommendation
of the EDSTAC, has proposed using five
longer-term reproduction studies that,
with one exception, are routinely
performed for pesticides with
widespread outdoor exposures that are
expected to affect reproduction. (Id. at
71555). EPA is examining, pursuant to
the suggestion of the EDSTAC,
modifications to these studies to
enhance their ability to detect endocrine
effects.
EPA has published a draft list of the
first group of chemicals that will be
tested under the Agencys endocrine
disruptor screening program. (72 FR
33486 (June 18, 2007)). The draft list
was produced based solely on the
exposure potential of the chemicals and
EPA has emphasized that [n]othing in
the approach for generating the initial
list provides a basis to infer that by
simply being on this list these chemicals
are suspected to interfere with the
endocrine systems of humans or other
species, and it would be inappropriate
to do so. (Id.)
D. EPAs Human Research Rule
EPA decisions regarding the ethics of
human studies are governed by the
Protection for Subjects in Human
Research final rule (Human Research
rule), which significantly strengthened
and expanded protections for subjects of
human research. (71 FR 6138 (February
6, 2006)). The framework of the Human
Research rule rests on the basic
principle that EPA will not, in its
actions, rely on data derived from
unethical research. The rule divides
studies involving intentional dosing of
human subjects into two groups: new
studies - those initiated after April 7,
2006 (the effective date of the rule) - and
old studies - those initiated before
April 7, 2006. The Human Research
Rule forbids EPA from relying on data
from any new study, unless EPA has
adequate information to determine that
the research was conducted in
substantial compliance with the ethical
requirements contained therein. (40
CFR. 26.1705). These ethical rules are
derived primarily from the Common
Rule, (40 CFR part 26), a rule setting
ethical parameters for studies conducted
or supported by the federal government.
In addition to requiring informed
consent and protection of the safety of
the subjects, among other things, the
rule specifies that [r]isks to subjects
[must be] reasonable in relation to . . .
the importance of the knowledge that
may reasonably be expected to result
[from the study]. (40 CFR
26.1111(a)(2)). In other words, a study
would be judged unethical if it did not
have scientific value outweighing any
risks to the test subjects.
As to old studies, the Human
Research Rule forbids EPA from relying
on such data if there is clear and
convincing evidence that the conduct of
the research was fundamentally
unethical or significantly deficient with
respect to the ethical standards
prevailing at the time the research was
conducted. (40 CFR 26.1704). EPA has
indicated that in evaluating the ethical
standards prevailing at the time the
research was conducted it will
consider the Nuremburg Code, various
editions of the Declaration of Helsinki,
the Belmont Report, and the Common
Rule, as among the standards that may
be applicable to any particular study.
(71 FR at 6161). Further, reflecting the
concern that scientifically invalid data
are always unethical, (71 FR at 6160),
the rule limits the human research that
can be relied upon by EPA to
scientifically valid and relevant data.
(40 CFR 26.1701).
Whether the data are new or old,
the Human Research rule forbids EPA
from relying on data from any study
involving intentional exposure of
pregnant women, fetuses, or children
subject to a very limited exception. (40
CFR 26.1703, 1706).
To aid EPA in making scientific and
ethical determinations under the
Human Research rule, the rule
established an independent Human
Studies Review Board (HSRB) to
review both proposals for new research
(new studies) and reports of
completed human research (old
studies) on which EPA proposes to rely.
(40 CFR 26.1603). The rule directs that
HSRB shall be comprised of non-EPA
employees who have expertise in fields
appropriate for the scientific and ethical
review of human research, including
research ethics, biostatistics, and human
toxicology. (40 CFR 26.1603(a)). If EPA
decides to rely on the results from old
research conducted to identify or
measure a toxic effect, EPA must submit
the results of its assessment to the HSRB
for evaluation of the ethical and
scientific merit of the research. (40 CFR
26.1602(b)(2)).
EPA has established the HSRB as a
federal advisory committee under the
Federal Advisory Committee Act
(FACA) to take advantage of the
benefits of the transparency and
opportunities for public participation
that accompany a FACA committee. (71
FR at 6156). The HSRB, as appointed by
EPA, contains approximately 16
distinguished experts in the fields of
bioethics, biostatistics, human health
risk assessment and human toxicology,
primarily from academia. (Ref. 12).
NRDC and other parties have
challenged the legality of the Human
Research rule. (NRDC v. U.S. EPA, No.
06-0820-ag (2d Cir.)). A decision on this
challenge is presently pending before
the United States Court of Appeals for
the Second Circuit.
IV. Regulatory History of DDVP
A. In General
1. DDVP use. Dichlorvos (2, 2-
dichlorovinyl dimethyl phosphate), also
known as DDVP, is an insecticide used
in controlling flies, mosquitoes, gnats,
cockroaches, fleas, and other insect
pests. (Ref. 3). DDVP is registered for
use on agricultural sites; commercial,
institutional, and industrial sites; and
for domestic use in and around homes.
Agricultural and other commercial uses
include in greenhouses; mushroom
houses; storage areas for bulk, packaged
and bagged raw and processed
agricultural commodities; food
manufacturing/processing plants;
animal premises; and non-food areas of
food-handling establishments. It is also
registered for treatment of cattle, poultry
and swine. DDVP is not registered for
direct use on any field grown
commodities. Currently, there are 27
tolerances listed in 40 CFR 180.235 for
DDVP on agricultural (food and feed)
crops and animal commodities. DDVP is
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applied with aerosols, fogging
equipment, and spray equipment, and
through use of impregnated materials
such as resin strips which result in slow
release of the pesticide. The current
registrant for the technical active
ingredient, DDVP, is Amvac Chemical
Corporation (Amvac).
2. DDVP risks. The following
information on the assessment of the
risks posed by DDVP is drawn from
EPAs decision on the reassessment of
DDVP tolerances and its response to
NRDCs petition.
DDVP is a chlorinated
organophosphate pesticide which
inhibits plasma, RBC, and brain
cholinesterase in a variety of species.
(Ref. 3 at 122-123). Subchronic and
chronic oral DDVP exposures to rats and
dogs as well as chronic inhalation DDVP
exposure to rats resulted in significant
decreases in plasma, RBC and/or brain
cholinesterase activity. However, DDVP
does not cause delayed neurotoxicity in
the hen. Repeated, oral subchronic
DDVP exposures in male humans were
associated with statistically and
biologically significant decreases in RBC
cholinesterase inhibition. There was no
evidence of increased susceptibility to
young animals following in utero DDVP
exposure to rat and rabbit fetuses as
well as pre/post natal DDVP exposure to
rats in developmental, reproduction,
and comparative cholinesterase studies.
Evidence of sensitivity in the young was
seen in one parameter, auditory startle
amplitude, in a developmental
neurotoxicity study; however, the
effects in the rat pups here was at levels
well above levels which result in RBC
cholinesterase inhibition. Cancer
studies with DDVP provide suggestive
evidence of DDVPs potential human
carcinogenicity; however, following the
advice of numerous independent
scientific panels, EPA has determined
that DDVP poses a negligible cancer risk
to humans due to the lack of relevance
to humans of the tumors identified in
the DDVP cancer studies. (72 FR at
68671-68673).
Inhibition of cholinesterase activity
was the toxicity endpoint selected to
assess hazards for all acute and chronic
dietary exposures, as well as short-,
intermediate-, and long-term (chronic)
dermal, inhalation, and incidental oral
residential exposures. Doses selected for
the Point of Departure in determining
the level of concern - i.e., RfD/PADs and
acceptable MOEs - were based on both
human and animal studies. (Ref. 3 at
130-135). Animal studies were used in
choosing levels of concern for
evaluating risk from acute and chronic
dietary exposure; acute dermal
exposure; and acute and chronic
inhalation exposure. A human study
was used evaluating risk from short-
term incidental oral exposure; short-,
intermediate-, and long-term dermal
exposure; and short- and intermediate-
term inhalation exposure.
Safety factor determinations used in
selecting the level of concern differed
based on whether EPA relied on one of
several different animal studies or a
human study. For levels of concerns
derived from a Point of Departure from
an animal study, EPA generally applied
a 100X safety factor (10X for inter-
species variability and 10X for intra-
human variability). EPA removed the
10X childrens safety factor for risk
assessments based on an animal study.
For levels of concerns derived from a
Point of Departure from the human
study, EPA applied a 10X safety factor
for intra-human variability and a 3X
childrens safety factor. (Id.).
EPA based its decision to remove the
childrens safety factor when relying on
animal data on its conclusions that (1)
the toxicity database was complete; (2)
most of the data indicated no sensitivity
in the young and the only evidence of
sensitivity occurred at levels well above
the Points of Departure used for
establishing the levels of concern; and
(3) its estimate of human exposure to
DDVP was not understated. EPA
retained a portion of the childrens
safety factor when relying on the human
study because that study did not
determine a NOAEL. EPA concluded,
however, that reliable data supported
reduction of the 10X factor because the
effect seen at the LOAEL in that study
was so marginal that a lower dose
would have been unlikely to detect any
adverse effect. (72 FR 68694-68695).
EPA has estimated exposure to DDVP
taking into account the potential for
DDVP residues in food, drinking water,
and in the home as the result of the use
of DDVP pest strips. DDVP exposure
may result not only from use of DDVP
but use of two closely-related pesticides,
naled and trichlorfon, which metabolize
or degrade to DDVP in food, water, or
the environment. In assessing the risks
of DDVP, EPA has taken into account
exposure to DDVP resulting from use of
all three of these pesticides. (Ref. 3 at
147-149). Additionally, DDVP, naled,
and trichlorfon are within a family of
pesticides known as the
organophosphates. EPA has classified
the organophosphate pesticides and
their common cholinesterase-inhibiting
degradates as having a common
mechanism of toxicity. Thus, in
addition to assessing the risks posed by
exposure to organophosphate pesticides
individually, EPA has assessed the
potential cumulative effects from
concurrent exposure to
organophosphate pesticides. (Ref. 13).
As discussed in Unit IV.B.1. below,
taking all of the above information into
account, EPA concluded that the
tolerances for DDVP were safe.
B. FFDCA Tolerance Reassessment and
FIFRA Pesticide Reregistration
1. In general. As required by the
FQPA of 1996, EPA reassessed the
safety of the DDVP tolerances under the
new safety standard established in the
FQPA. EPA released for comment a
preliminary risk assessment for DDVP in
October, 2000. (65 FR 60430 (October
11, 2000)). Subsequently, after
consideration of public comment, EPA,
on June 30, 2006, issued an Interim
Reregistration Eligibility Document
(IRED) for DDVP. In that document,
EPA determined that aggregate exposure
to DDVP as a result of use of DDVP,
naled, and trichlorfon, complied with
the FQPA safety standard. (Ref. 3 ).
Separately, on July 31, 2006, EPA
determined that cumulative ffects from
exposure to all organophosphate
residues were safe. (Ref. 14). In
combination, these findings satisfied
EPAs obligation to review the DDVP
tolerances under the new safety
standard.
As a result of the FIFRA reregistration
and FFDCA tolerance reassessment
process there were numerous changes
made to DDVPs registration that affect
non-occupational exposure to DDVP.
Specifically, on May 9, 2006, EPA
received from Amvac, the only
registrant of DDVP as a product for
manufacturing end-use DDVP products,
an irrevocable request to cancel certain
uses and include additional pest strip
label restrictions on the DDVP active
ingredient product labels. Pursuant to
section 6(f) of FIFRA, on June 30, 2006,
the Agency published a notice in the
Federal Register that it had received the
request and sought comment on EPAs
intention to grant the request and cancel
the specified uses. (71 FR 37570 (June
30, 2006)). On October 20, 2006, EPA
issued the final cancellation order. (71
FR 61968 (October 20, 2006)).
The added restrictions on the use of
the pest strip products were approved
on October 11, 2006, and provided,
among other things, that large pest strips
could no longer be used in homes
except for garages, attics, crawl spaces,
and sheds that are occupied for less
than 4 hours per day. The only pest
strips permitted for use in occupied
areas inside the home were significantly
smaller strips for use in closets,
wardrobes, or cupboards. Additionally,
in early March, 2007, Amvac requested
the voluntary cancellation of all its pet
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collar and bait registrations and deletion
of those uses from its technical label.
Pursuant to section 6(f) of FIFRA,
Amvacs requests to cancel the pet
collar and bait registrations as well as
deleting such uses from the technical
label were published in the Federal
Register on March 23, 2007. (72 FR
13786 (March 23, 2007)). On June 27,
2007, EPA issued the final cancellation
notice for the pet collar and bait
registrations. (72 FR 35235 (June 27,
2007)).
Cancellation of uses and label
restrictions imposed on Amvacs
registration apply to all formulated
DDVP end-use products because it is
unlawful to use a pesticide in a manner
inconsistent with its label. (7 U.S.C.
136(ee)). This bar on use inconsistent
with the label applies to the formulation
of end-use pesticide products from
manufacturing use products.
Accordingly, because Amvac holds the
only registration for a DDVP
manufacturing use product, the removal
of uses and the addition of restrictions
with respect to Amvacs manufacturing
use product label has the effect of
imposing those use cancellations and
label restrictions on all DDVP end-use
products.
2. Review of human study.
Completion of the DDVP IRED was
delayed, in part, by questions regarding
whether it was appropriate for EPA to
rely on several human toxicity studies
conducted with DDVP which were
submitted by Amvac. The study
receiving principal attention was a
study involving repeated dosing over
several days conducted in 1997 by A.J.
Gledhill. (Refs. 3 at 133; and 15). That
study is identified by the Master Record
Identification (MRID) number of
44248801. Amvac also cited
approximately a dozen other human
studies, several of which were also
conducted by Gledhill. (Ref. 16).
Following promulgation of the
Human Research rule, EPA evaluated
whether the human data submitted by
Amvac complied with the rule, and,
pursuant to the rules requirements,
presented these data and its
recommendations to the Human Studies
Review Board (HSRB) for review. On
March 9, 2006, the HSRB published a
notice in the Federal Register
announcing that a public meeting would
be held to consider the DDVP studies as
well as human studies for several other
pesticides. (71 FR 12194 (March 9,
2006)). The meeting was scheduled for
April 4-6, 2006. The notice alerted the
public of the opportunity to file both
written comments with the HSRB and to
make oral comments at the April
meeting. The members of the HSRB at
the time of this meeting are listed in
Appendix 1.
NRDC filed written comments with
the HSRB concerning DDVP, (Ref. 17),
and also presented oral testimony at the
public meeting. (Ref. 18). NRDCs
comments and oral remarks specifically
focused on whether the Gledhill study
had sufficient statistical power to
detect an effect when it may occur and
the fact that the Gledhill study only
used healthy, male test subjects. (Ref. 7
at 13). Other subjects discussed at the
meeting included the relative strengths
and weaknesses of the Gledhill study
such as its repeat dosing regime, the
failure to test blood plasma
cholinesterase, the failure to monitor
subjects after testing, and the studys
consent form. (Id.; Ref. 18 at 18, 20-23).
On May 23, 2006, the HSRB published
a notice in the Federal Register alerting
the public that it had released a draft
report (dated May 16, 2006) and would
be holding a public teleconference
meeting on June 6, 2006 to discuss its
draft report. (71 FR 29624 (May 23,
2006)). The notice included instructions
on how members of the public could
participate in the teleconference and
explained the procedure for providing
oral and written comments. (Ref. 19).
NRDC did not file comments on the
draft report. (Ref. 20).
On June 26, 2006, the HSRB issued its
finding that reliance on the Gledhill
human study was appropriate given that
the study had scientific value and there
was no clear and convincing evidence
that the study was fundamentally
unethical. (Ref. 21). The HSRB
concluded that the other DDVP human
studies should not be used in the DDVP
risk assessment. These findings were
unchanged from its May 16, 2006 draft
report.
EPA agreed with the findings of the
HSRB and relied upon the HSRBs
reasoning in using the Gledhill study in
its DDVP risk assessment. (72 FR at
68675).
V. NRDC Petition Regarding DDVP
On June 2, 2006, the NRDC filed a
petition with EPA which, among other
things, requested that EPA: (1) Conclude
the DDVP Special Review by August 3,
2006, with a finding that DDVP causes
unreasonable adverse effects on the
environment; (2) conclude the DDVP
FIFRA reregistration process by August
3, 2006, with a finding that DDVP is not
eligible for reregistration; (3) submit
draft notices of intent to cancel all
DDVP registrations to the FIFRA
Scientific Advisory Panel and USDA by
August 3, 2006, and issue those notices
60 days thereafter; (4) conclude the
DDVP tolerance reassessment process by
August 3, 2006, with a finding that the
DDVP tolerances do not meet the
FFDCA safety standard; and (5) issue a
final rule by August 3, 2006, revoking
all DDVP tolerances. (Ref. 2). Shortly
after the petition was filed, on June 30,
2006, EPA released the IRED for DDVP
which addressed DDVPs eligibility for
reregistration under FIFRA and
assessed, in part, whether DDVPs
tolerances met the new safety standard
enacted by the FQPA. NRDC submitted
comments on the IRED and some of
these comments bore on issues in its
petition. (Ref. 3).
NRDCs petition contained dozens of
claims as to why DDVPs registration
under FIFRA should be canceled and its
FFDCA tolerances revoked. These issues
are not presented in detail here because
many raised solely FIFRA concerns and
NRDC has not pursued most of its
tolerance-related claims in its objections
and hearing requests.
EPA published notice of the petition
for comment on October 11, 2006. (71
FR 59784 (October 11, 2006)). EPA
received roughly 1,500 brief comments
in support of the petition. These
comments added no new information
pertaining to whether the tolerances
were in compliance with the FFDCA.
Detailed comments in opposition to the
petition were submitted by Amvac. (Ref.
22).
EPA responded to the petition in
three separate documents: (1) It issued
an order closing out the DDVP Special
Review; (72 FR 72709 (December 21,
2007)); (2) it issued an order denying the
request to cancel DDVPs FIFRA
registration (72 FR 68581(December 5,
2007)); and (3) it issued an order
pursuant to FFDCA section 408(d)(4)(iii)
denying the request to revoke DDVPs
FFDCA tolerances (78 FR 68662
(December 5, 2007). Todays final order
only concerns the objections filed to the
section 408(d)(4)(iii) order denying the
request to revoke tolerances.
VI. EPA Response to the Petition to
Revoke DDVP Tolerances
EPA issued a section 408(d)(4)(iii)
order responding to the petitions
request to revoke DDVP tolerances on
December 5, 2007 (hereinafter referred
to as EPAs petition response or
petition denial order). (72 FR 68662
(December 5, 2005). That order denied
the petition finding that none of the
grounds asserted by NRDC
demonstrated that the DDVP tolerances
should be revoked. Nonetheless, EPA
did conclude that NRDC raised several
pertinent concerns with EPAs
assessment of the risks posed by DDVP.
To respond to NRDCs concerns, EPA
completely revamped both its dietary
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and residential risk assessments. In its
new risk assessments, EPA included
updated information on residue levels
of DDVP in food, the amount of usage
of DDVP and related pesticides in
agriculture, and food consumption
patterns of infants and children. EPA
also adopted modified and more
conservative assumptions regarding
exposure patterns to DDVP in
residential settings and exposure to
DDVP from naleds use to control
mosquitoes. Because, however, EPA
concluded that the revised risk
assessments still showed that the DDVP
tolerances are safe, EPA denied NRDCs
petition.
EPAs specific responses to the claims
in the petition that are relevant to
NRDCs objections are summarized in
the portion of this order responding to
the objections and hearing requests.
VII. NRDCs Objections and Requests
for Hearing
On February 1, 2008, NRDC filed,
pursuant to FFDCA section 408(g)(2),
objections to EPAs denial of its
tolerance revocation petition and
requested a hearing on those objections.
As indicated above, NRDCs objections
and requests for hearing raise two main
claims: (1) that EPA has unlawfully
failed to retain the full 10X safety factor
for the protection of infants and
children; and (2) that it was unlawful
for EPA to rely on a toxicity study for
DDVP that was conducted with humans.
NRDC cites three grounds for its
assertion that EPA unlawfully lowered
the 10X childrens safety factor: (1) that
EPA lacked adequate data on DDVPs
potential effects on the endocrine
system; (2) that EPA lacked adequate
data on several matters related to
assessing dietary exposure to DDVP
residues in food; and (3) that EPA has
inadequate data on exposure to DDVP
from its use in residential pest strips. As
to the DDVP human study, NRDC
claimed that EPAs regulation
concerning use of human studies is
unlawful and that the study is
scientifically flawed and ethically
compromised. In analyzing NRDCs
claims, EPA has broken NRDCs two
main claims down into 19 separate sub-
issues. Each sub-issue is described in
detail and responded to separately in
Unit VIII.
In support of its request for hearing,
NRDC proffered the following
documents as evidence that a hearing
would be appropriate:
(1) the Interim Reregistration Eligibility
Determination for DDVP; (2) the entire record
for the IRED and the documents referenced
and cited therein; (3) NRDCs comments on
the IRED; (4) EPAs petition denial and the
references cited in that denial; (5) NRDCs
petition and all references cited in the
petition; and (6) the arguments, citations, and
attachments contained in these objections.
(Ref. 1 at 3) (citations and references to
attachments omitted).
VIII. Response to Objections and
Requests for Hearing
A. Overview
EPA denies each of NRDCs objections
as well as its hearing requests. NRDCs
hearing requests fail to meet the
statutory and regulatory requirements
for holding a hearing. NRDC has failed
to proffer evidence on its hearing
requests which would, if established,
resolve one or more issues in its favor.
Rather, NRDC relies on mere allegations
and general denials and contentions.
Further, many of NRDCs claims do not
present genuine and substantial issues
of fact and/or are immaterial to the relief
requested. On the merits, NRDCs
objections are denied for substantially
the same reasons given in EPAs petition
denial order. NRDCs objections largely
restate the claims in its petition.
Significantly, NRDC does not
acknowledge or respond to the
substantial revisions to the DDVP
dietary and residential risk assessments
made in response to the NRDC petition.
Similarly, NRDC does not acknowledge
or respond to EPAs detailed summary
of why it adopted the conclusion by the
independent HSRB that the Gledhill
human study complied with EPAs
Human Research rule.
The remainder of this Unit is
organized in the following manner. Unit
VIII.B. describes in greater detail the
requirements pertaining to when it is
appropriate to grant a hearing request.
Unit VIII.C. examines the evidence
proffered by NRDC in support of its
hearing requests. Units VIII.D. and E.
provide EPAs response to the NRDCs
objections and hearing requests. Unit
VIII.D. addresses NRDCs claims
regarding the childrens safety factor
and subunit E addresses NRDCs
arguments concerning reliance on the
Gledhill human study. EPAs
conclusions on the hearing requests and
objections are summarized in Units
VIII.F. and G., respectively.
EPA has adopted a 4-part format in
Units VIII.D. and E. for explaining its
ruling on each of the 19 sub-issues EPA
identified in the objections. First,
NRDCs claim and any arguments or
evidence tendered to support that claim
are described. Second, background
information on the claim is provided
including whether and how the claim
was presented in NRDCs petition and,
if it was presented, EPAs reasons for
denying the claim in its earlier petition
denial order. Third, EPA explains its
reasons for denying a hearing on that
claim. Finally, EPA explains its reasons
for denying the claim on the merits.
B. The Standard for Granting an
Evidentiary Hearing
EPA has established regulations
governing objections to tolerance
rulemakings and tolerance petition
denials and requests for hearings on
those objections. (40 CFR Part 178; 55
FR 50291 (December 5, 1990)). Those
regulations prescribe both the form and
content of hearing requests and the
standard under which EPA is to
evaluate requests for an evidentiary
hearing.
As to the form and content of a
hearing request, the regulations specify
that a hearing request must include: (1)
a statement of the factual issues on
which a hearing is requested and the
requestors contentions on those issues;
(2) a copy of any report, article, or other
written document upon which the
objector relies to justify an evidentiary
hearing; and (3) a summary of any
other evidence relied upon to justify a
hearing. (40 CFR 178.27).
The standard for granting a hearing
request is set forth in section 178.32.
That section provides that a hearing will
be granted if EPA determines that the
material submitted shows all of the
following:
(1) There is a genuine and substantial issue
of fact for resolution at a hearing. An
evidentiary hearing will not be granted on
issues of policy or law.
(2) There is a reasonable possibility that
available evidence identified by the requestor
would, if established, resolve one or more of
such issues in favor of the requestor, taking
into account uncontested claims or facts to
the contrary. An evidentiary hearing will not
be granted on the basis of mere allegations,
denials, or general descriptions of positions
and contentions, nor if the Administrator
concludes that the data and information
submitted, even if accurate, would be
insufficient to justify the factual
determination urged.
(3) Resolution of the factual issue(s) in the
manner sought by the person requesting the
hearing would be adequate to justify the
action requested. An evidentiary hearing will
not be granted on factual issues that are not
determinative with respect to the action
requested. For example, a hearing will not be
granted if the Administrator concludes that
the action would be the same even if the
factual issue were resolved in the manner
sought.
(40 CFR 178.32(b)).
This provision essentially imposes
four requirements upon a hearing
requestor. First, the requestor must
show it is raising a question of fact, not
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one of law or policy. Hearings are for
resolving factual issues not for debating
law or policy questions. Second, the
requestor must demonstrate that there is
a genuine dispute as to the issue of fact.
If the facts are undisputed or the record
is clear that no genuine dispute exists,
there is no need for a hearing. Third, the
requestor must show that the disputed
factual question is material - i.e., that it
is outcome determinative with regard to
the relief requested in the objections.
Finally, the requestor must make a
sufficient evidentiary proffer to
demonstrate that there is a reasonable
possibility that the issue could be
resolved in favor of the requestor.
Hearings are for the purpose of
providing objectors with an opportunity
to present evidence supporting their
objections; as the regulation states,
hearings will not be granted on the basis
of mere allegations, denials, or general
descriptions of positions or
contentions. (40 CFR 178.32(b)(2)).
EPAs hearing request requirements
are based heavily on FDA regulations
establishing similar requirements for
hearing requests filed under other
provisions of the FFDCA. (53 FR 41126,
41129 (October 19, 1988)). FDA
pioneered the use of summary
judgment-type procedures to limit
hearings to disputed material factual
issues and thereby conserve agency
resources. FDAs use of such procedures
was upheld by the Supreme Court in
1972, (Weinberger v. Hynson, Westcott
& Dunning, Inc., 412 U.S. 609 (1973)),
and, in 1975, FDA promulgated generic
regulations establishing the standard for
evaluating hearing requests. (40 FR
22950 (May 27, 1975)). It is these
regulations upon which EPA relied in
promulgating its hearing regulations in
1990.
Unlike EPA, FDA has had numerous
occasions to apply its regulations on
hearing requests. FDAs summary of the
thrust of its regulations, which has been
repeatedly published in the Federal
Register in orders ruling on hearing
requests over the last 24 years, is
instructive on the proper interpretation
of the regulatory requirements. That
summary states:
A party seeking a hearing is required to
meet a threshold burden of tendering
evidence suggesting the need for a hearing.
[] An allegation that a hearing is necessary to
sharpen the issues or fully develop the
facts does not meet this test. If a hearing
request fails to identify any evidence that
would be the subject of a hearing, there is no
point in holding one.
A hearing request must not only contain
evidence, but that evidence should raise a
material issue of fact concerning which a
meaningful hearing might be held. [] FDA
need not grant a hearing in each case where
an objection submits additional information
or posits a novel interpretation of existing
information. [] Stated another way, a hearing
is justified only if the objections are made in
good faith and if they draw in question in
a material way the underpinnings of the
regulation at issue. Finally, courts have
uniformly recognized that a hearing need not
be held to resolve questions of law or policy.
(49 FR 6672, 6673 (February 22, 1984);
72 FR 39557, 39558 (July 19, 2007)
(citations omitted)). EPA has been
guided by FDAs application of its
regulations in this proceeding.
Congress confirmed EPAs authority
to use summary judgment-type
procedures with hearing requests when
it amended FFDCA section 408 in 1996.
Although the statute had been silent on
this issue previously, the FQPA added
language specifying that when a hearing
is requested, EPA shall . . . hold a
public evidentiary hearing if and to the
extent the Administrator determines
that such a public hearing is necessary
to receive factual evidence relevant to
material issues of fact raised by the
objections. (21 U.S.C. 346a(g)(2)(B)).
This language grants EPA broad
discretion to determine whether a
hearing is necessary to receive factual
evidence to objections.
C. Evidentiary Proffer by NRDC
As noted above, the purpose for
holding hearings is to receive factual
evidence. (U.S.C. 346a(g)(2)(B); 53 FR
41126, 41129 (Hearings are for the
purpose of gathering evidence on
disputed factual issues . . . .)). A
requestor must identify evidence relied
upon to justify a hearing and either
submit copies of that evidence or
summarize it. (40 CFR 178.27). After
reviewing the proffer, EPA must find
that there is a reasonable possibility that
the proffered evidence, if established,
would resolve one or more genuinely-
disputed, material factual issues in a
requestors favor. (40 CFR 178.32(b)).
Because a substantial portion of NRDCs
evidentiary proffer is deficient on its
face, EPA finds it most efficient to
preliminarily review the proffer before
turning to the individual issues raised
by NRDC.
As previously mentioned, NRDC
proffered the following items as
evidence supporting its requests for
hearing:
(1) the Interim Reregistration Eligibility
Determination for DDVP; (2) the entire record
for the IRED and the documents referenced
and cited therein; (3) NRDCs comments on
the IRED; (4) EPAs petition denial and the
references cited in that denial; (5) NRDCs
petition and all references cited in the
petition; and (6) the arguments, citations, and
attachments contained in these objections.
(Ref. 1 at 3). These items can be divided
into two groups: (1) items produced or
assembled by EPA (the IRED; the IRED
record; and EPAs petition denial); and
(2) items produced by NRDC (NRDCs
comments on the IRED; NRDCs
petition; and NRDCs objections).
The items in the first group - the EPA
documents - clearly do not constitute a
proper proffer. Essentially, this is a non-
specific identification of every
document and piece of data EPA has
considered and relied upon in the
multi-year process of conducting the
FIFRA reregistration and FFDCA
tolerance reassessment for DDVP and in
responding to NRDCs DDVP petition.
This could easily encompass hundreds,
if not thousands of documents, and tens
of thousands of pages of analysis and
data. EPAs petition response alone
cited 82 documents and those
documents generally were EPA
analytical papers and not the underlying
data. EPA concludes that NRDCs
citation to the thousands of pages in the
IRED, the IRED record, and the petition
denial is so vague a proffer as to not
constitute a proffer at all. It would be as
if a lawyer, in responding to a courts
request for case law authority for a
principle he or she was defending, cited
the court to Wests Federal Reporter, 3rd
Series. While somewhere in those
hundreds of volumes a case may exist
that supports the asserted principle, the
lawyer cannot be said to have identified
it by a vague wave at a substantial
portion of the law library. Further, given
that the purpose of a hearing is to gather
or receive evidence, proffering evidence
already considered and relied upon by
EPA would not seem to be grounds for
holding a hearing. Finally, as a matter
of law, EPA does not understand how it
can be argued that a proffer consisting
of a general reference to a record of
decision which EPA has found
supported one result could constitute
evidence that if established, would
justify the opposite conclusion. At
bottom, the proffer of the items in the
first group fails to identify evidence
which would, if established, resolve an
issue in NRDCs favor.
NRDCs second group of documents
consists of NRDCs comments on the
IRED; NRDCs petition; and NRDCs
objections. In analyzing this proffer,
EPA has focused on NRDCs objections
because the objections appear to
contain, almost word-for-word, the
arguments and claims put forward in its
petition and IRED comments with
regard to the childrens safety factor and
reliance on human studies. The
objections reference 16 documents. For
the reasons explained below, 10 of these
documents can be rejected on their face
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as not justifying a hearing. Four of the
documents, however, potentially
include factual evidence supporting a
hearing and are analyzed more
thoroughly in connection with the
specific issue in the hearing request to
which they are tied. The other two
documents that are referenced are
NRDCs DDVP petition and NRDCs
comments on the DDVP IRED. As
described above, these documents do
not add anything beyond what is in the
objections.
1. Documents that clearly do not
proffer evidence of a genuinely-
disputed, material issue of fact. (10
items)
Five Newspaper Stories. NRDC cites
to an Associated Press story from 2002
and four Los Angeles Times stories from
2007. These news stories contain basic
background information about DDVP;
general contentions from Amvac, NRDC,
and EPA regarding the safety of DDVP;
and no more than a cursory, passing
reference to any of the issues raised in
the petition. There can be no serious
contention that these articles present
evidence justifying a hearing.
NRDC comments to HSRB. NRDC
references the comments it submitted to
the HSRB with regard to the HSRBs
review of the human studies conducted
with DDVP. The comments - three pages
of bulleted talking points and one graph
- are a summary of the slightly more
detailed arguments contained in NRDCs
objections. This document adds no
justification for a hearing not otherwise
included in NRDCs objections.
2. Legal Briefs in NRDC v. EPA, No.
06-0820-ag (2d Cir.). NRDC cites to its
opening and reply briefs in NRDC v.
EPA, the case adjudicating NRDCs
challenge to EPAs Human Research
rule. These briefs contain legal
arguments regarding the lawfulness of
the Human Research rule. They contain
no factual evidence justifying NRDCs
DDVP hearing requests.
Three Law Review Articles. NRDC
references: (1) a short article by a NRDC
attorney summarizing his legal
objections to EPAs Human Research
rule; (2) an article concerning EPAs
implementation of the FQPA; and (3) an
article focusing on how tort law might
be used to supplement the FQPA to
protect children. None of these articles
mention DDVP and no serious
contention can be made that they
provide factual evidence justifying a
hearing.
3. Documents which may present
evidence of a genuinely-disputed,
material issue of fact. (4 items)
Lockwood Articles. NRDC cites two
articles by Dr. Alan Lockwood which
discuss science and ethical issues with
regard to several human intentional
dosing studies involving pesticides.
Several of the human studies addressed
were DDVP studies, one of which is the
Gledhill human study that is the focus
of this proceeding. Whether the
information presented in these articles
supports NRDCs hearing requests is
examined in Unit VIII.E.3.a.
Sass Letters. NRDC cites two letters
published in the journal Environmental
Health Perspectives co-authored by Dr.
Jennifer Sass of NRDC. These letters
discuss science and ethical issues with
regard to two human studies, including
the DDVP human study in question in
this proceeding. Whether the
information presented in these letters
supports NRDCs hearing requests is
examined in Unit VIII.E.3.a.
D. Response to Specific Issues Raised in
Objections and Hearing Requests -
Childrens Safety Factor
1. Failure to support childrens safety
factor decision with DDVP-specific
data a. Objection/hearing request sub-
issue. NRDC asserts that EPA, in
choosing a 3X childrens safety factor
for DDVP, did not rely on reliable data
showing that such a factor was safe for
infants and children because EPAs
choice of 3X is not based on any data
specific to DDVP. (Ref. 1 at 5). NRDCs
argument is that EPA erred by not
deriving a precise safety factor for DDVP
but instead used a value that EPA
considered to be half of the 10X safety
factor. NRDC claims that EPA could
not have determined that such margin
[i.e., 3X] will be safe, when the
replacement safety factor is simply a
generic stand-in for EPAs conclusion
that something less than 10X is
enough. (Id.). According to NRDC, EPA
should have explained what reliable
data supports a 3X safety factor in
particular, as opposed to 4X or some
other number, for DDVP specifically.
(Id.).
b. Background. Similar assertions
were made in NRDCs petition and its
IRED comments. For example, the
petition claimed that [t]he Agency did
not explain why it chose 3X as opposed
to 4X or any other factor, (Ref. 2 at 14),
and the IRED comments asserted that
there was a complete lack of
explanation for EPAs safety factor
decisions. (Ref. 23 at 5). Both
documents also alleged there were
inadequacies in the toxicity and
exposure databases. (Refs. 2 at 15, and
38-41; and 23 at 8-9).
In response to these claims by NRDC,
EPA, in the petition response,
comprehensively restated its reasoning
for its decisions on the childrens safety
factor for DDVP in the IRED. (72 FR at
68694-68695). EPA noted that it had a
complete toxicity database for DDVP
and it carefully reviewed the evidence
regarding the sensitivity of the young to
DDVP and explained why an additional
safety factor was not needed to protect
infants and children. Further, EPA
detailed why it had concluded that its
exposure assessments would not
understate human exposure to DDVP.
For some DDVP risk assessments EPA
chose to remove the childrens safety
factor entirely, and for others EPA
reduced the safety factor to 3X. EPA
explained that it retained a 3X
childrens safety for certain assessments
because the toxicity study which was
relied upon in conducting those risk
assessments had not identified a no
adverse effect level (NOAEL) in its
subjects but rather only a lowest
adverse effect level (LOAEL).
Despite the failure to identify a NOAEL
in the study, EPA concluded that a 3X
factor would be more than adequate to
identify a NOAEL based upon the slight
adverse effect (marginal RBC
cholinesterase inhibition in a human
study) observed at the LOAEL. (72 FR
at 68695). EPA noted that an
independent science review board had
confirmed that lower doses were
unlikely to produce a measurable effect.
Finally, EPA explained why it chose 3X
instead of 4X or some other value. (Id.).
The petition response noted that where
the data does not warrant a full 10X,
EPA generally does not attempt to
mathematically derive a precise
replacement safety factor because
regulatory agencies traditional use of
10X safety factors (upon which the
FQPA safety factor was modeled) was
based on rough estimates rather than
detailed calculations. Instead, where a
10X factor would clearly overstate the
uncertainty, EPA simply applies a factor
valued at half of 10X. (Id.). EPA
explained that it considers 3X to be half
of 10X assuming a lognormal
distribution of effects. (Id.).
c. Denial of hearing request. In
analyzing whether a hearing would be
appropriate on this sub-issue, it is
helpful to break the sub-issue down into
three separate, but related, questions: (1)
Whether EPA, in selecting a childrens
safety factor lower than 10X, is required
to justify with precision why it chose
one factor over another; (2) whether
EPA offered a justification for the
childrens safety factor it chose; and (3)
whether EPA relied upon DDVP specific
information in choosing a safety factor
or instead relied upon generic
assertions. When broken down in this
way, it is clear that none of these
questions meets the standard for a
hearing.
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The first question is a pure question
of law - does FFDCA section 408(c)
require EPA to offer a reasoned
explanation for its choice of a childrens
safety factor, including an explanation
as to why a different factor is not
needed. A question of fact, not of law,
is required to justify a hearing. (40 CFR
178.32(b)(1)).The second and third
questions fail to present a matter of
genuinely-disputed facts because it is
plain on the record that EPA did offer
a reasoned justification for its decision
and, in that justification, relied upon
DDVP-specific facts. EPAs petition
response to NRDCs 10X arguments laid
out in careful detail information
regarding the extent of the toxicity and
exposure database on DDVP and the
data bearing on DDVPs effects on young
animals. (72 FR at 68694-68695
(discussing the completeness of the
DDVP toxicity database, DDVP studies
bearing on pre- and post-natal toxicity,
and the basis for DDVP exposure
estimates)). Further, NRDC proffers no
evidence - because there is none to
proffer - suggesting that EPA did not
consider DDVP-specific information in
making its childrens safety factor
decision. Therefore, this question does
not meet the standard for a hearing both
because there are no genuinely-disputed
facts and NRDC has proffered no
evidence which, if established, could
resolve this issue in its favor. 57 FR
6667, 6672 (February 27, 1992) (A
hearing must be based on reliable
evidence, not on mere allegations or on
information that is inaccurate and
contradicted by the record.)
d. Denial of objection. EPA agrees
with NRDC that general principles of
administrative law require it to provide
a reasoned explanation for its decision
on selection of a childrens safety factor.
(Baltimore Gas & Electric Co. v. NRDC,
462 U.S. 87, 103 (1983)). EPA disagrees
with NRDC, however, to the extent it is
suggesting that as part of this reasoned
explanation for its selection of a
childrens safety factor, EPA must show
why it did not choose some other
mathematical value. Rather, the statute
imposes upon EPA, if it decides to vary
from the presumptive 10X childrens
safety factor, the burden to show that
any different safety factor is safe.
Once EPA has made that showing, its
obligation to offer a reasoned
explanation is complete. Because EPA
offered a reasoned explanation as to
why the childrens safety factors it
chose protect the safety of infants and
children, (72 FR 68694-68695), EPA
denies NRDCs objection on this point.
As to the substance of EPAs
explanation of why it chose a 3X safety
factor for certain DDVP risk
assessments, NRDC claims that EPA
erred because its choice of 3X is based
on a generic assertion not [] on any
data specific to DDVP. (Ref. 1 at 5).
NRDC is wrong. The generic assertion
NRDC mentions is EPAs explanation of
why 3X is half of 10X. EPAs choice of
3X, however, is not based on its
conclusion that 3X is half of 10X but on
the data in the DDVP human study at
issue. As noted above, the petition
response explained in detail that a full
10X safety factor was not needed to
address the uncertainty raised by the
failure of the DDVP human study to
identify a NOAEL. The effects seen in
that study at the LOAEL were only
marginally adverse at best, and
therefore, EPA concluded that applying
the full 10X safety factor (i.e., dividing
the LOAEL by another factor of 10X in
addition to the 10X factor for intra-
human variability) was more than was
needed to address the lack of a NOAEL.
The HSRB confirmed as much when it
wrote: because the decreased activity
in RBC cholinesterase activity observed
in this study was at or near the limit of
what could be distinguished from
baseline values, it was unlikely that a
lower dose would produce a measurable
effect in RBC cholinesterase activity.
(Ref. 21 at 41).
EPA chose a safety factor of 3X for
DDVP based on its conclusion that not
only was 10X overprotective but that 3X
would be protective given the results
seen in the relevant DDVP study. (72 FR
at 68695). As EPA concluded in the
petition denial order: a 3X safety factor
would be more than adequate to identify
a NOAEL based upon the slight adverse
effect (marginal RBC cholinesterase
inhibition in a human study) observed
at the LOAEL. (Id.). Generally, EPA
uses a 3X safety factor as the default
value when reducing a 10X safety factor.
(Refs. 5 at 9-10, 26; and 24 at 4-40 - 4-
41; ). A safety factor of 3X is deemed to
be approximately half the value of a
safety factor of an order of magnitude
(10X). As EPA explained in the petition
denial order:
In choosing a safety factor in circumstances
where the data does not warrant a full 10X,
EPA generally does not attempt to
mathematically derive a precise replacement
safety factor because regulatory agencies
traditional use of 10X safety factors (upon
which the FQPA safety factor was modeled)
was based on rough estimates rather than
detailed calculations. Instead, where a 10X
factor would clearly overstate the
uncertainty, EPA simply applies a factor
valued at half of 10X. In determining half of
a 10X factor, EPA assumes that the
distribution of effects within the range of a
safety factor is distributed lognormally
(which is generally the case for biological
effects), and reduction of a lognormal
distribution by half is equal to half a log
(10
-5
) or approximately 3X. A lognormal
distribution is a distribution which if plotted
based on the logarithm of each of its values
would yield a bell-shaped (normal)
distribution but if plotted according to actual
values would be skewed having a clumping
of values along the vertical axis of the plot.
(72 FR at 68695) (citations omitted).
NRDC does not challenge EPAs
reasoning regarding whether the choice
of 3X is justified based on the results of
a DDVP-specific study and thus, the
merits of EPAs DDVP-specific
reasoning is not here at issue. Rather,
NRDC denies that EPA engaged in
DDVP-specific reasoning in choosing
3X. Because NRDCs argument is
contradicted on the face of the petition
response, it is denied.
2. Endocrine effects. As described
below, NRDC claims that EPA cannot
remove the childrens safety factor
because it has not completed the
endocrine screening program for DDVP
under section 408(p) and because EPA
has inadequate endocrine data for
DDVP. Although NRDC did argue in its
petition that EPA cannot make a safety
finding without completing the
endocrine screening program, it did not
assert claims regarding endocrine data
and the childrens safety factor. EPA has
previously ruled that a petitioner may
not raise new issues in filing objections
to EPAs denial of its Original petition.
(72 FR 39318, 39324 (July 18, 2007)
(The FFDCAs tolerance revocation
procedures are not some sort of game,
whereby a party may petition to revoke
a tolerance on one ground, and then,
after the petition is denied, file
objections to the denial based on an
entirely new ground not relied upon by
EPA in denying the petition.)).
Accordingly, NRDCs objections and
hearing requests as to the childrens
safety factor and endocrine data are
denied.
Even if these claims were properly
presented in these objections, for the
reasons set forth below they neither
entitle NRDC to a hearing nor justify the
relief sought.
a. Endocrine disruptor screening
programi. Objection/hearing request
sub-issue. NRDC argues that EPA must
retain the 10X childrens safety factor
because EPA has not fulfilled its
obligations under FFDCA section 408(p)
to screen pesticides, including DDVP,
for endocrine disruption potential. (Ref.
1 at 5). Essentially, NRDC argues that
EPA must retain the childrens safety
factor for any pesticide until testing
under the endocrine screening program
is completed for that pesticide.
ii. Background. In its petition, NRDC
claimed that failure to conduct the
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endocrine screening program for DDVP
under section 408(p) made it impossible
for EPA to conclude that the DDVP
tolerances are safe. (Ref. 2 at 49). EPA
responded to this argument by citing its
denial of a petition to revoke various
pesticide tolerances in which the claim
was made that EPA could not remove
the childrens safety factor if endocrine
screening under section 408(p) had not
been conducted. (72 FR at 68676).
There, EPA concluded that the statute
did not impose a mandatory bar upon
removal of the childrens safety factor
until completion of the endocrine
screening program. (71 FR 43906, 43920
(August 2, 2006)). EPA also found in
responding to the prior petition that it
had sufficient data on endocrine
screening for the pesticide in question
to make a safety finding. (71 FR at
43920-43921). After analyzing the
endocrine data for DDVP, EPA
concluded that it had sufficient data to
make a safety finding as to DDVP. (72
FR at 68676 - 68677).
iii. Denial of hearing request. The
question of whether completion of the
endocrine screening program under
FFDCA section 408(p) is a mandatory
prerequisite to removal of the childrens
safety factor is a legal issue. A question
of fact, not of law, is required to justify
a hearing. (40 CFR 178.32(b)(1)).
iv. Denial of objection. In response to
a prior pesticide tolerance revocation
petition, and objections filed as to EPAs
denial of that petition, EPA has already
rejected the legal claim presented in this
objection. (71 FR at 43920; 72 FR 39318,
39327-39328 (July 18, 2007). After
analyzing the statutory language,
structure, and legislative history, EPA
concluded that section 408(p) does not
override the clear and unmistakable
language[] [in section 408(b)(2)(C)]
grant[ing] EPA discretion to make a fact-
based determination of whether a safety
factor different than the 10X default
value is safe for children. (71 FR at
43920). EPA summarized its reasoning
as follows:
under section 408(b)(2)(C) EPA clearly has
the discretion to determine, in any given
case, whether it has reliable data to choose
a factor different than the 10X default value.
Not only is there no statutory language
supporting the [petitioners] argument in
favor of automatic retention of the 10X until
completion of the endocrine screening
program but the legislative history is in no
way supportive of construing the enactment
of the program as intended to have such a
dramatic impact. Further, since the
enactment of the FQPA, EPAs
contemporaneous and consistent approach to
the endocrine screening program has been to
treat that information-gathering exercise as
not imposing some type of statutorily-
prescribed, automatic injunction barring
removal of the childrens safety factor until
completion of information-gathering under
the program.
(Id.). EPA also catalogued the extensive
data requirements already in place for
pesticides that produced information on
a pesticides potential endocrine effects.
(71 FR at 43920-43921). EPA concluded
that in many instances the totality of
the information gleaned from current
data required for pesticides used on
food will make it possible to develop a
meaningful weight-of-the-evidence
determination on the potential of the
pesticide to adversely affect the
endocrine system. (Id.).
NRDC has done nothing more than
state in a conclusory fashion that
completion of endocrine screening
under section 408(p) is necessary to a
decision to remove the childrens safety
factor. Accordingly, EPA denies this
objection for the reasons stated in its
previous two orders addressing this
claim. (71 FR at 43920 - 43921; 72 FR
at 39327-39328).
b. DDVP endocrine datai.
Objection/hearing request sub-issue. In
its objections, NRDC argues that EPA
has inadequate data on endocrine effects
to remove the childrens safety factor.
As support for this argument NRDC
asserts: (1) that the studies relied upon
by EPA were not designed to detect
endocrine disruption . . . ; and (2) that
the two-generation rat reproduction
study does not meet EPAs 1998
guideline for such studies and, given
that the reproduction study did show
endocrine effects, a [p]roper
histopathology in the two generation rat
reproduction study could have revealed
adverse effects at lower levels than the
levels at which cholinesterase inhibition
was seen in DDVP studies. (Ref. 1 at 6).
ii. Background. As noted above,
NRDCs petition argued that EPA could
not make a safety finding for DDVP in
the absence of data collected under the
section 408(p) screening program. EPA
responded to this claim by examining
the data on DDVP bearing on its
potential endocrine effects. EPA
concluded that it could make a safety
finding for DDVP in absence of further
endocrine data given that: (1) data
bearing on potential endocrine effects
from a two-generation reproduction
study as well as other chronic data in
which effects on reproductive organs
were examined; (2) EPA well
understands DDVPs most sensitive
mechanism of toxicity (cholinesterase
inhibition); and (3) the potential
endocrine-related effects seen for DDVP
appeared in the presence of significant
cholinesterase inhibition and at levels
nearly two orders of magnitude above
the most sensitive cholinesterase effects.
. . . (72 FR at 68677).
iii. Denial of hearing request. A
hearing on this sub-issue is not
appropriate because NRDCs request is
based on mere allegations, general
contentions, and speculation. NRDC
claims that the studies EPA relied upon
were not designed to investigate
endocrine effects; however, NRDC
proffers no evidence to support such an
allegation. Further, such a claim has
little, if any, materiality, given that the
important question is not whether the
studies were designed to measure
endocrine effects but whether they
actually measure such effects. Notably,
NRDC does not, and cannot upon this
record, make the latter contention. (See
72 FR at 68676 (discussing the
numerous endocrine-related endpoints
assessed in the DDVP database)).
Further, NRDCs claim that if the DDVP
two-generation rat reproduction study
had been conducted pursuant to the
1998 guidelines it might have shown
endocrine effects at lower doses than
the doses at which DDVPs
cholinesterase effects were seen is
nothing more than speculation. In
applying its hearing regulations, FDA
has routinely denied hearings on
speculation about what redoing a study
might show. For example, in a
proceeding establishing a food additive
regulation for acesulfame potassium,
FDA denied a hearing to an objector
who challenged FDAs rejection of a
study for only containing partial
histopathological data. (57 FR 6667
(February 27, 1992)). The objector had
argued that full histopathological data
might have altered FDAs conclusion.
FDA found such an argument
unconvincing: Because complete
histopathological examination of tissues
from all animals in the first rat study
was not done and cannot be done now,
any prediction of the results of such an
examination is simply speculation.
Speculation regarding data that do not
exist cannot serve as the basis for a
hearing. (Id. at 6671). For all of the
above reasons, the hearing request on
this sub-issue is denied.
iv. Denial of objection. EPA denies
NRDCs objection that EPA does not
have adequate endocrine data on DDVP
to remove the childrens safety factor.
First, NRDC is wrong to imply that
existing, required toxicity studies do not
provide valuable information on
potential endocrine effects. EPA
discussed this issue in detail in an
earlier order involving similar claims
concerning a different pesticide. There,
EPA pointed out that:
The primary proposed Tier 2 study [for the
Endocrine Disruptor Screening Program]
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relevant to endocrine effects on humans is
the 2-generation reproductive toxicity study
in rats. This is one of the core studies
required for all food-use pesticides since
1984. In this reproduction study, potential
hormonal effects can be detected through
behavioral changes, ability to become
pregnant, duration of gestation, signs of
difficult or prolonged parturition, apparent
sex ratio (as ascertained by anogenital
distances) of the offspring, feminization or
masculinization of offspring, number of
pups, stillbirths, gross pathology and
histopathology of the vagina, uterus, ovaries,
testis, epididymis, seminal vesicles, prostate,
and any other identified target organs. In fact,
EPA, in 1998, in discussing this studys use
in Tier 2, identified 39 endpoints examined
in this study relevant to estrogenic,
androgenic, or thyroid effects. At that time,
EPA noted that it was evaluating whether to
add another 10 endocrine-related endpoints
to the study protocol to enhance the utility
of the study to detect endocrine effects.
Despite the ongoing evaluation of additional
endpoints, EPA has concluded that the
existing 2-generation mammalian assay is
valid for the identification and
characterization of reproductive and
developmental effects, including those due to
endocrine disruption, based on the long
history of its use, the endorsement of the
1998 test guideline by the FIFRA Scientific
Advisory Panel, and acceptance by member
countries of the Organizations for Economic
Cooperation and Development (OECD).
(71 FR 43906, 43921 (August 2, 2006)
(citations omitted)). That order also
catalogued the numerous endocrine-
related endpoints in other chronic
toxicities routinely-required for
pesticides used on agricultural
commodities. (Id.).
Specifically as to DDVP, in its
response to NRDCs petition, EPA
detailed four long-term DDVP toxicity
studies, submitted under EPA data
requirements that provided data on
numerous effects that are relevant to
potential endocrine disruption. EPA
wrote:
EPA has adequate data on DDVPs
potential endocrine effects to evaluate
DDVPs safety. In the 1989 NTP cancer
studies with rats and mice, male and female
reproductive organs (prostate, testes,
epididymis, ovaries, uterus) were examined
and no changes attributable to DDVP were
found. The 52week dog study with DDVP
also was without effect in the reproductive
organs (testes, prostate, epididymides, cervix,
ovaries, uterus, vagina). EPA also has a 1992
two-generation rat reproduction study with
DDVP (via drinking water) that is similar to
the most recent guidelines (1998) for conduct
of such a study with respect to endocrine-
related endpoints. Although that study did
not include certain evaluations that the 1998
guidelines recommended related to
endocrine-related effects (age of vaginal
opening and preputial separation), it did
incorporate other aspects of the 1998
guidelines such as an examination of
esterous cycling in females and sperm
number, motility, and morphology in males.
The study did identify an adverse effect on
esterous cycling in females but only at the
high dose (8.3 mg/kg/day). All doses in the
study showed significant cholinesterase
inhibition. Further, the NOAEL and LOAEL
from the esterous cycling endpoint in the
reproduction study are nearly two orders of
magnitude higher than the NOAEL and
LOAEL used as a Point of Departure in
setting the chronic RfD/PAD for DDVP.
(72 FR at 68676 (citations omitted).
Further, the petition response
additionally discussed a DDVP study
from the scientific literature examining
endocrine-related effects. (Id.).
NRDCs speculation - that further
testing of DDVP might reveal endocrine
effects at levels below those at which
cholinesterase inhibition has been
measured - does not convince EPA that
there is not a reliable basis for removing
the childrens safety factor as regards
endocrine effects. As EPA indicated in
its denial of the NRDC petition, it has
several studies addressing numerous
endpoints bearing on DDVPs potential
endocrine effects, DDVPs
cholinesterase inhibition effects are
well-defined by existing data, and the
only endocrine effect seen in the DDVP
data occurred in the presence of
significant cholinesterase inhibition and
at a level two orders of magnitude (i.e.,
100X) greater than the level at which the
most sensitive cholinesterase effects
were seen. As a pesticide, DDVP is
subject to testing under the endocrine
disruptor screening program; however,
EPA expects that that data will confirm
its conclusion regarding DDVPs
potential endocrine effects. NRDCs
objection on this point is denied.
3. Dietary exposurea. Objection/
hearing request sub-issue. NRDC claims
that there are numerous uncertainties in
EPAs estimate of dietary exposure to
DDVP from food and that these
uncertainties preclude EPA from
departing from the 10X childrens safety
factor. (Ref. 1 at 6). Specifically, NRDC
cites to a list of uncertainties noted by
EPA in a preliminary risk assessment for
DDVP released in 2000. Those
uncertainties involve the number of
infants surveyed for the food
consumption database; foods consumed
from farm stands; use of data on residue
decline from cooking studies; reliance
on the residue sampling from the FDA
Total Diet Study; and lack of monitoring
data, and extensive use of data
translation, for fumigated commodities.
With the exception of the infant
consumption issue, NRDC makes no
claim other than to allege that [e]ach of
these shortcomings poses a serious risk
of understating the risks posed by DDVP
contamination of food. (Id.). As to the
infant consumption data, NRDC offers
various challenges to the size and
representativeness of the group of
infants sampled in conjunction to the
2000 preliminary risk assessment.
NRDC acknowledges that EPA, in its
response to the NRDC petition, states
that it used updated infant consumption
data but NRDC objects that EPA does
not assert that these data represent a
statistically adequate or representative
sample. (Id.). Finally, NRDC implies
that EPA thinks the data are not reliable
by citing an EPA statement regarding
the reliability of monitoring data.
b. Background. NRDC made almost
identical claims in its petition to revoke
DDVP tolerances. EPA responded with a
detailed examination of each of the
factors cited by NRDC as well as several
additional factors. (72 FR at 68684-
68686). Where EPA identified
weaknesses in the exposure database it
either incorporated new, updated data
in its risk assessment (for example,
replacing data from the FDA Total Diet
Study with data from USDAs Pesticide
Data Program) or explained how that
weakness had been addressed by
conservative assumptions. (72 FR at
68684). This led to an entirely revised
dietary exposure and risk assessment for
DDVP. As to this revised assessment,
EPA concluded that its assessment of
exposure to DDVP from food will not
under-estimate but rather over-estimate,
and in all likelihood substantially over-
estimate, DDVP exposure. (72 FR at
68686). EPA also noted that the largest
driver or contributor to dietary
exposure of DDVP was DDVP in
drinking water and not DDVP in food.
(Id.). Specifically, as to food
consumption data for infants, EPA
stated that it had incorporated the most
recent consumption data for infants that
is used in all EPA pesticide risk
assessments currently in its revised risk
assessment for DDVP. This most recent
data was collected at the direction of
Congress in the FQPA. (Public Law 104-
170, sec. 301; 110 Stat. 1489, 1511).
c. Denial of hearing request. NRDCs
objection and request for a hearing on
this sub-issue suffers from several
infirmities. First, NRDC has objected to
an outdated document, EPAs
preliminary risk assessment for DDVP.
With the exception of the issue
concerning food consumption data for
infants, NRDC has made no effort to
object to EPAs current assessment of
the reliability of various factors cited by
NRDC in EPAs petition response issued
under FFDCA section 408(d)(4)(iii).
When an objector does not challenge
EPA conclusions in the section
408(d)(4)(iii) order but rather challenges
some prior conclusion that was
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superseded by the section 408(d)(4)(iii)
order, the objector has not raised a live
controversy as to an issue material to
the section 408(d)(4)(iii) order. (See 53
FR 53176, 53191 (December 30, 1988)
(where FDA responds to a comment in
the final rule, repetition of the comment
in objections does not present a live
controversy unless the objector proffers
some evidence calling FDAs conclusion
into question)). In fact, in these
circumstances, it is questionable
whether EPA has jurisdiction to
consider the objection and hearing
request because objections may only be
filed as to a section 408(d)(4)(iii) order
or other statutorily-specified action. (21
U.S.C. 346a(g)(2)(A)).
Second, NRDC has made no proffer of
evidence supporting its claim that each
of the factors cited from EPAs
preliminary risk assessment poses a
serious risk of understating the risks
posed by DDVP contamination of food.
(Ref. 1 at 6). NRDCs entire argument
concerning the effect these factors (other
than the infant food consumption data
issue) would have on the DDVP
exposure assessment is a single
conclusory sentence. A hearing will not
be granted on mere allegations or
general contentions. (40 CFR
178.32(b)(2)). Although NRDC discusses
the infant food consumption data issue
at greater length, this discussion
provides no support for granting a
hearing. NRDCs discussion is limited
to: (1) a presentation of a short analysis
of the adequacy of the superseded
consumption data as opposed to the
data upon which EPA relied in denying
NRDCs objection; and (2) a claim that
EPA has not made a finding that the
more recent infant food consumption
data represent a statistically adequate
or representative sample. (Ref. 1 at 6-
7). However, the superseded data is
irrelevant to the present proceeding and
the allegation about an absent finding is
framed as a procedural/legal challenge,
not an identification of evidence
supporting factual contentions. (See 53
FR 53176, 53199 (December 30, 1998)
(Rather than presenting evidence, [the
objector] asserts that FDA did not
adequately justify its conclusions. Such
an assertion will not justify a hearing.).
Third, ignoring for a moment the
other serious flaws identified above, a
hearing is inappropriate on this issue
because NRDC has not shown a
disputed factual issue. Rather, NRDC is
essentially arguing about the correct
conclusion that should be drawn from
the factual findings made by EPA in its
preliminary risk assessment. (47 FR
55471, 55474 (December 10, 1982)
([Objectors] assertion about this
evidence is, at best, an argument that a
different inference (i.e., that the pieces
are not reasonably uniform and cube
shaped) should be drawn from
established fact (the dimensions of the
pieces) than the agency has drawn. No
hearing is required in such
circumstances.).
Finally, this entire issue suffers a
materiality problem because dietary
exposure to DDVP in food is so small
relative to other DDVP exposures. As
EPA noted in its petition denial, the
latest dietary assessment shows that,
by a large margin, the biggest driver in
the DDVP dietary risk assessment are
DDVP residues in water not food. (72
FR at 68686). Moreover, in evaluating
aggregate exposure to DDVP from all
sources EPA found that dietary
exposure from food and water was
insignificant compared to exposures
from pest strips. NRDC has made no
showing that its concerns regarding
dietary exposure to DDVP in food are
material to the overall exposure
assessment. (See 53 FR 53176, 53202
(December 30, 1998) (The objector
claims that radiation causes nutrient
loss but to justify a hearing on this
point, it is not enough for [the objector]
to simply assert that some nutrient loss
can occur. [The objector] must present
evidence that suggests that nutrient
losses in food irradiated at doses
permitted by the regulation are
sufficiently large and would so affect
the diet that such food would be
nutritionally unwholesome or unsafe.).
For all of the above reasons, NRDCs
hearing request on the adequacy of the
DDVP dietary exposure assessment are
denied.
d. Denial of objections. EPA questions
whether NRDCs repetition of EPAs
statements from a preliminary risk
assessment constitute an objection to a
superseding risk assessment in a section
408(d) petition denial. In any event,
EPA has already explained in great
detail in its petition denial why the
factors cited in its preliminary risk
assessment do not raise a concern that
EPA in its latest assessment has
understated DDVP dietary exposure. To
the contrary, EPA concluded that its
dietary assessment will over-estimate,
and in all likelihood substantially over-
estimate, DDVP exposure. (72 FR at
68686). Accordingly, NRDCs objections,
to the extent they merely repeat the
claims in the petition, are denied for the
same reasons stated in the petition
denial. (72 FR at 68684-68686).
EPA also denies NRDCs apparent
objection that the updated infant food
consumption data is unreliable and thus
EPA may not depart from the 10X
childrens safety factor. The only two
grounds NRDC cited for this objection
were: (1) EPAs alleged failure to
confirm that these data are statistically
adequate or [a] representative sample;
and (2) a reference EPA made to
monitoring data. NRDCs arguments
here are without merit.
EPA has traditionally relied upon
large scale surveys of food consumption
conducted by the USDA in assessing
dietary exposure and risk from
pesticides. USDA generally conducts
these surveys roughly every 10 years.
EPA currently relies primarily on the
Continuing Survey of Food Intakes by
Individuals (CSFII) which was
conducted in 1994-96. Prior surveys
were performed by USDA in 1977-78
and 1989-91. The 1994-96 CSFII was
supplemented in 1998 to expand the
number of data points for infants and
children. As EPA has explained: These
surveys were designed to monitor food
use and food consumption patterns in
the U.S. population. The data were
collected as a multistage, stratified,
probability sample that was
representative of the U.S. population. []
The most recent survey (CSFII 1994-
1996/1998) was designed to obtain a
sample that would provide equal
precision over all sex-age domains. The
data are used by a number of federal and
state agencies to improve understanding
of factors that affect food intake and the
nutritional status of the U.S. population.
[EPAs Office of Pesticide Programs]
considers the CSFII data adequate to
model the daily variability in the U.S.
diet. (Ref. 5 at 39).
The 1998 supplemental survey was
collected in response to the mandate in
the FQPA specifying that USDA, in
consultation with EPA, was to
coordinate the development and
implementation of survey procedures to
ensure that adequate data on food
consumption patterns of infants and
children are collected. (Public Law
104-170, sec. 301; 110 Stat. 1489, 1511).
Congress specified that [t]o the extent
practicable, [these] procedures [] shall
include the collection of data on food
consumption patterns of a statistically
valid sample of infants and children.
(Id.). Working together, EPA and USDA
adopted a survey plan designed to be
statistically reliable and representative.
(Refs. 25 and 26). The 1998 survey
involved sampling of 5,559 infants and
children. When combined with the
4,253 infants and children from the
1994-96 survey, the total sample size for
infants and children in the two surveys
is near 10,000. EPA and USDA
concluded that that the sample sizes
for each sex-age group [from the
combined surveys] provide a sufficient
level of precision to ensure statistical
reliability of the estimates except as to
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certain low consumption items for
individual age groups (e.g., infant
consumption of lettuce). (Ref. 25 at 1).
Comparison of the 1994-96 and 1998
surveys indicated few statistical
differences in nutrient consumption for
the different age groups with the
exception of 3-5 year olds. Even so,
[t]he differences seen, although
statistically significant, were relatively
small and likely to be of little practical
or biological significance. (Ref. 26 at 2-
3).
Because EPA, in conjunction with
USDA, has taken care to insure that its
surveys of food consumption constitute
a statistically valid and representative
sample of infants and children, NRDCs
unsupported objection suggesting that
this data is somehow inadequate is
rejected.
NRDCs reference to an EPA statement
about monitoring data does not in any
way undermine this conclusion. EPA
began a section of the petition denial
which discusses, among other things,
monitoring data of residues in food,
infant food consumption data, and
fumigant monitoring data, with the
broad statement that [i]n general, EPA
disagrees that the monitoring data are
unreliable. (72 FR at 68684). While
NRDC highlights the qualifying
language in general, it ignores the
critical following sentence that
provides: To the contrary, EPA
believes that the monitoring data
provide for an appropriately
conservative risk assessment. (Id.). The
first sentence was qualified by the
phrase [i]n general, because in two
instances the EPAs residue monitoring
data were less than optimal; however, as
noted in the second sentence, EPA
concluded that the risk assessment was
appropriately conservative because
either the data in question were
insignificant or other factors
compensated for any uncertainty in the
data. The first instance involved residue
monitoring data for one minor
commodity (berries not including
strawberries) out of dozens of
commodities where EPA relied on FDA
enforcement monitoring data rather than
its preferred source, data from USDAs
Pesticide Data Program. EPA prefers
using the USDA data because it is
collected using a sampling plan
designed to capture a representative
sample of food in the United States,
whereas sampling for FDA enforcement
data is targeted at food where violations
are more likely to occur. Such targeted
enforcement data generally overstates,
in comparison to a more representative
sample, both the frequency of finding
pesticide residues in commodities and
the level of the residues detected. In the
second instance, fumigant monitoring
data was not available for all bagged and
packaged commodities so EPA
translated data across commodities.
Although noting that this translation
introduced some uncertainty, EPA
concluded that this uncertainty was
more than offset by other factors,
including a testing procedure that
utilized maximum application rates and
sampling within six hours of treatment
and the assumption that all bagged and
packaged commodities would be
treated. Finally, the mention of
monitoring data is a reference to
studies that monitor residues in food
not surveys of peoples food
consumption patterns. The latter topic
was inadvertently included in a section
of the order devoted to [f]ood
monitoring data. (72 FR at 68683).
Thus, the sentence cited by NRDC does
not even refer to food consumption
survey data.
4. Pest strip exposure. NRDC claims
that EPAs assessment of exposure to
DDVP from residential pest strips is
based on unsupported assumptions and
inadequate data. (Ref. 1 at 8).
Accordingly, NRDC concludes the EPA
lacks reliable data on DDVP exposure
from pest strips and cannot reduce or
remove the 10X childrens safety factor.
EPA has identified seven separate
allegations made by NRDC and they are
analyzed individually below.
a. Representativeness of Collins and
DeVries studyi. Objection/hearing
request sub-issue. NRDC argues that the
Collins and DeVries study which EPA
used to estimate DDVP exposure from
pest strips had an inadequate sample
size (15 houses). According to NRDC, 15
houses is not adequate to represent the
diversity of housing in the United States
given the variations in housing design
and ventilation characteristics. (Ref. 1 at
7). Additionally, NRDC claims that,
because the study was conducted in a
single geographic area and for a period
no longer than 91 days, it does not
account for the varying weather
conditions which can have differential
effects on the movement and
degradation of airborne residues.
ii. Background. NRDC made the
identical claim in its petition. EPAs
response in its petition denial order was
two-fold. First, EPA pointed out that the
Collins and DeVries study was not the
only study considered by EPA in
assessing DDVP exposure from pest
strips. EPA reviewed several other
studies involving over 100 homes in the
United States and Europe. The results in
the Collins and DeVries study were
consistent with the results in the other
studies and, thus, EPA concluded that it
was reasonable to use the data from the
Collins and DeVries study in assessing
DDVP risk. (72 FR at 68692). Second, in
response to this claim (as well as several
of NRDCs other claims), EPA
substantially revised the DDVP
exposure and risk assessment. (72 FR at
68687-68691). Additional conservative
assumptions were adopted and these
conservative assumptions further offset
any theoretical unrepresentativeness of
the Collins and DeVries study. These
assumptions were that exposed
individuals spent 24 hours per day in a
treated home, that a person spent all of
the 24 hours per day in a room in the
house with a pest strip, and that
inclusion of a pest strip in a closet
resulted in the same exposure as
hanging the strip in the room itself.
Further, EPA no longer averaged the
exposure results from the houses in the
study but evaluated each house
individually.
iii. Denial of hearing request. NRDCs
request for hearing on this issue is
flawed for two reasons. First, as in its
petition, NRDC proffers no evidence to
support its claim that the Collins and
DeVries study is inadequate due to the
diversity of housing stock and
geographic conditions in the United
States. NRDC merely asserts that to be
the case. However, hearings will not be
granted on the basis of mere allegations
or general contentions. (40 CFR
178.32(b)(2); see also 68 FR 46403,
46406-46407 (8/5/2003) (FDA denied a
hearing involving a challenge to FDAs
reliance on consumption pattern data
because the objector did not present
any specific information to dispute P &
Gs consumption pattern data; instead,
[objector] simply asserted that other
consumption patterns were likely.);
accord Community Nutrition Institute v.
Novitch, 773 F.2d 1356, 1363 (D.C. Cir.
1985) (Mere differences in the weight
or credence given to particular scientific
studies . . . are insufficient [to show a
material issue of fact for a hearing].)).
Second, NRDCs hearing request is
inadequate because NRDC does not
object to the basis EPA asserted in its
petition denial for concluding that the
Collins and DeVries study does provide
a sufficient basis for estimating
residential exposure. Specifically,
NRDC does not challenge EPAs
conclusion that the Collins and DeVries
study is consistent with several other
pest strip studies and proffer evidence
in support of that challenge. Neither
does NRDC challenge and proffer
evidence regarding EPAs conservative
use of the Collins and DeVries study in
assessing exposure. Rather, NRDC just
repeats its assertions regarding the
unrepresentativeness of the Collins and
DeVries study from its petition. This
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failure to challenge the basis of EPAs
petition denial affects the materiality of
the objection and hearing request. Even
if NRDC could demonstrate in a hearing
that the ventilation design of a house,
for example, can affect the rate at which
airborne contaminants are dissipated,
that evidence would not contradict the
fact that the Collins and DeVries study
is consistent with DDVP pest strip
studies in over 100 other homes in
varying locations.
Prior FDA decisions under its
regulations are instructive here.
Objections and hearing requests were
filed in response to a food additive
regulation covering the irradiation of
poultry. (62 FR 64102 (December 3,
1997). The objector argued that the
addition of an anti-oxidant (ethoxyquin)
to irradiated chicken prior to the
chickens use in animal feeding studies
compromised the studies because the
ethoxyquin would have decreased the
level of lipid peroxides in the chicken
to levels found in chicken that had not
been irradiated. The FDA noted,
however, that it had considered the
question of ethoxyquins effect on lipid
peroxide levels in the final rule and
determined that while ethoxyquin can
retard the normal oxidation of chicken
fat to peroxides, ethoxyquin cannot
reverse oxidation that has already
occurred. FDA denied the hearing
request reasoning that because the
objector did not dispute FDAs
explanation in the final rule as to why
addition of ethoxyquin did not
compromise the CIVO studies, and
provided no information that would
have altered the agencys conclusion on
this issue . . . there is no factual issue
that can be resolved by available and
specifically identified reliable
evidence. (62 FR at 64105; see also 53
FR 53176, 53191 (December 30, 1988)
(FDA denied a hearing request noting
that given FDAs prior conclusion that
the studies relied upon by the objector
were unreliable, the burden shifted to
[the objector] to maintain the viability of
its objection by proffering some
information that called into question the
agencys conclusion on this matter.)).
Similarly, here, NRDC has not
challenged the basis EPA asserted for
rejecting NRDCs challenge to EPAs
reliance on the Collins and DeVries
study and NRDC has not proffered any
information calling into question EPAs
conclusion.
iv. Denial of objection. Because NRDC
offers no basis for its objection to EPAs
denial of the challenge in its petition to
EPAs reliance on the Collins and
DeVries studyother than the claims
made in its petition, itselfEPA denies
the objections for the reasons in the
petition denial order (i.e., the
consistency of the Collins and DeVries
study with other DDVP pest strip
studies and the conservativeness of the
DDVP pest strip exposure assessment).
b. Sampling location in the Collins
and DeVries studyi. Objection/hearing
request sub-issue. NRDC argues that the
Collins and DeVries study is flawed
because air concentration levels of
DDVP were sampled in only one
location in the house. According to
NRDC, this sampling regime was
inadequate because it provides no
information about the movement of
residues from room-to-room and
therefore exposure in other rooms in the
homes. (Ref. 1 at 7).
ii. Background. NRDC repeats this
claim verbatim from its petition. The
petition denial order rejected this
challenge to the Collins and DeVries
study and the manner of EPAs use of
the study in its exposure assessment
noting that the sample location in each
instance was in a room with a pest strip,
pest strips were used in other rooms of
the house, and EPA assumed, for its
calculation of the MOE, that the air
concentration for all areas of a house is
the same as at the sampled location.
(72 FR at 68692).
iii. Denial of hearing request. This
objection and hearing request does not
involve a genuine and substantial issue
of disputed fact. There is no dispute
concerning how or where sampling was
done in the Collins and DeVries study
or how EPA used that data in estimating
DDVP exposure from pest strips.
NRDCs objection attacks EPAs
conclusion that it is reasonable to assess
residential DDVP exposure from pest
strips using air concentrations of DDVP
from rooms which contained a pest
strip. A challenge to an EPA inference
drawn from undisputed facts does not
qualify as a disputed factual question.
(47 FR 55471, 55474 (December 10,
1982) ([Objectors] assertion about this
evidence is, at best, an argument that a
different inference (i.e., that the pieces
are not reasonably uniform and cube
shaped) should be drawn from
established fact (the dimensions of the
pieces) than the agency has drawn. No
hearing is required in such
circumstances.)). Moreover, NRDC
does not explain why knowledge of the
amount of room-to-room DDVP
movement is relevant given that EPA
based its exposure assumption on the
level of DDVP found in a room with a
pest strip, much less proffer any
evidence to suggest why this issue is
material and should be resolved in its
favor. For all of these reasons, NRDCs
hearing request on this issue is denied.
iv. Denial of objection. This objection
is denied for the same reason stated in
the petition denial order: knowledge of
the amount of room-to-room movement
of DDVP is irrelevant if EPA bases its
exposure assessment on a room that
contains a pest strip. In both its petition
and its objections, NRDC cites the
following statement from EPAs
preliminary risk assessment as
supporting its conclusion regarding the
inadequacy of use of a single air monitor
in the Collins and DeVries study: A
more accurate exposure would be
possible if air measurements were
available from different rooms in the
house. (Ref. 1 at 7). NRDC, however,
misunderstands the thrust of this
sentence. EPA was simply pointing out
that monitoring in rooms without pest
strips would have provided a more
accurate and realistic - i.e., lower -
estimate of exposure than using values
from a room containing a pest strip. The
sentences immediately following the
language quoted by NRDC make this
clear. EPA stated: Limited data suggest
that the level of Dichlorvos in the air
declines with distance from the resin
pest strip. There are data from the
Dichlorvos Flea Collar Study that show
Dichlorvos levels are lower some
distance away from the pet flea collar.
(Ref. 27 at 53).
c. Averaging DDVP concentrations
over 120 daysi. Objection/hearing
request sub-issue. NRDC objects to
EPAs assessment of exposure to pest
strips challenging EPAs alleged use of
a 120day average of DDVP
concentration levels. NRDC argues that
[r]ather than using averages, the
Agency should have presented the range
of risks displayed over time, peak
measurements, and the daily monitoring
data so that trends over time could be
determined. (Ref. 1 at 7).
ii. Background. NRDC repeats this
claim verbatim from its petition. In its
petition denial order, EPA agreed with
NRDC and revised its residential
exposure assessment to examine
exposure and risk based on the first day
of exposure after hanging the pest strip,
the first 2 weeks of exposure, and
exposure over a 91 day period. (72 FR
at 68687).
iii. Denial of hearing A hearing can
only be based on a genuine issue of
disputed fact. Where a partys factual
allegations are contradicted by the
record, there is no genuine dispute. (57
FR 6667, 6672 (February 27, 1992) (A
hearing must be based on reliable
evidence, not on mere allegations or on
information that is inaccurate and
contradicted by the record.).
iv. Denial of objection. NRDCs
objection is directed at a prior,
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superseded risk assessment, not the risk
assessment relied upon in the petition
denial order. Thus, this objection is not
material to this proceeding and is
denied. (See Unit VIII.D.3.c.).
d. Replacement cycle for pest strips
i. Objection/hearing request sub-issue.
NRDC objects to EPAs assumption that
pest strips are replaced no more
frequently than 120 days even though
the pest strip label does not prohibit
more frequent replacement. (Ref.1 at 8).
NRDC argues that EPA has no data to
substantiate this assumption and claims
that homeowners may decide to
replace strips sooner for good
measure. (Id.). Recognizing that EPA
decreased its assumption concerning the
replacement cycle to 91 days in the
revised risk assessment in the petition
denial order, NRDC asserts that this
value is equally arbitrary.
ii. Background. The challenge to the
120day replacement assumption was
included in NRDCs petition. EPA
responded to NRDCs argument in the
petition denial order by decreasing its
assumption as on the replacement cycle
of pest strips to 91 days. (72 FR at
68692).
iii. Denial of hearing. This sub-issue
does not meet the standard for a
hearing. NRDC disputes the
reasonableness of EPAs choice of a
replacement cycle for pest strips in the
absence of a restriction on the pesticide
label or data documenting consumer
usage. NRDC proffers no evidence
challenging EPAs use of a 91day
replacement cycle. Rather, NRDC asserts
a legal argument that in the absence of
specific data on consumer usage, EPA
may not make an assumption about
consumer practices. Hearings are not
appropriate on legal questions. (40 CFR
178.32(b)(1)). Similarly, NRDCs
speculation about how often
homeowners may replace pest strips
does not constitute an evidentiary
proffer justifying a hearing. (See 57 FR
33244, 33248 (July 27, 1992) (NRDC
claimed that the removal of premix
batch analysis would lead to
misformulation of selenium in feeds. A
hearing was denied because NRDC
provided no factual information to
support its claim . . . . [A] hearing will
not be granted on the basis of mere
allegations.)).
iv. Denial of objection. In its
preliminary risk assessment and in the
IRED, EPA assumed that pest strips
would be replaced no more frequently
than 120 days because the pest strip
label specifies: Drafts, weather, and
other conditions may affect the
performance, but treatment usually last
for 4 months. Record the date of
installation and replace with a new,
fresh, full-strength strip at the end of 4
months or when effectiveness
diminishes. (Ref. 28). Given that the
manufacturer was essentially
designating 120 days as the likely
effective period and that consumers
might leave the pest strips up for either
longer or shorter periods, EPA assumed
that 120 days was a reasonable estimate
of the average replacement cycle for pest
strips. EPA generally uses average
values for chronic exposure scenarios
because over time high and low values
tend to average out. (Ref. 5 at 42).
Nonetheless, in recognition of NRDCs
contention that homeowners might
replace strips more frequently, EPA
amended its pest strip exposure to
assume a 91day replacement cycle (the
length of the Collins and DeVries study)
rather than extrapolate the data from the
Collins and DeVries study over 120 days
as was done previously. EPA believes 91
days is a reasonable estimate of the
replacement cycle especially given the
label language and the numerous
conservative assumptions in the risk
assessment such as, for example, the
assumption of 24 hours per day
exposure in a room containing a pest
strip. Accordingly, NRDCs objection on
this sub-issue is denied.
e. Number of pest stripsi. Objection/
hearing request sub-issue. NRDC claims
that EPAs assessment of DDVP
exposure from pest strips is not based
on adequate data because EPA does not
have any data on how many strips
people use in their homes. EPA assessed
residential DDVP exposure based on the
Collins and DeVries study which used
3-4 strips per house in each of the
studied houses. NRDC argues that some
homeowners may use more than 3-4
strips because there is no limitation on
the label as to the number of strips per
house.
ii. Background. NRDC repeats this
claim verbatim from its petition. EPA
rejected NRDCs concern in the petition
denial order reasoning that its
assessment was based on data on the air
concentration of DDVP in a room
containing a pest strip. (72 FR at 68692).
EPA also noted that the only strips
allowed in occupied areas of the home
under the current registration are for
closets, wardrobes, or cupboards and
given that they treat a relatively small
space, compared to the bigger strips
used in the Collins and DeVries study,
they are unlikely to result in significant
DDVP air concentrations in rooms other
than in the room containing the treated
area. (Id.).
iii. Denial of hearing. NRDC has not
alleged and proffered evidence on a
genuine and substantial issue of
disputed fact. NRDC speculates that use
of pest strips in every, or almost every,
room in a house may lead to higher
residues in a room containing a pest
strip than a room containing a pest strip
in a house which has a pest strip in 3-
4 rooms. Based on this speculation,
NRDC claims that EPAs exposure
assessment is inadequate because EPA
has not documented how many strips
people use in their houses. A hearing
will not be granted on the basis of mere
allegations or speculation about what
other studies might show. (See 57 FR
33244, 33248 (July 27, 1992) (NRDC
claimed that the removal of premix
batch analysis would lead to
misformulation of selenimum in feeds.
A hearing was denied because NRDC
provided no factual information to
support its claim . . . . [A] hearing will
not be granted on the basis of mere
allegations.)).
iv. Denial of objection. For several
reasons, NRDCs speculation that a
house containing strips in nearly every
room might lead to greater DDVP
exposures than estimated by EPA must
be rejected. First, EPA based its DDVP
pest strip exposure assessment on a
study (Collins and DeVries) which
measured DDVP concentrations in a
room containing a pest strip. Second,
the Collins and DeVries study did not
involve a house with a single strip but
used pest strips in 3-4 rooms of the
studied houses. Third, the results of the
Collins and DeVries study were
consistent with the results of several
other pest strip studies. Fourth,
although corrected for the smaller size
of current pest strips compared to the
pest strips used in the Collins and
DeVries study, EPA did not adjust its
assessment for the fact that current
strips may not be used for general space
treatment but must be put in closets,
wardrobes, or cupboards. Taking into
account these factors, EPAs assessment
of exposure from DDVP pest strips was
reasonable and based upon adequate,
reliable data to reduce or remove the
childrens safety factor.
f. Exposure time per dayi.
Objection/hearing request sub-issue.
NRDC objects that it was unreasonable
for EPA to assume that the high end
exposure period in the home is 16 hours
and that a low end exposure period is
2 hours. NRDC argues that some groups
of people may spend significantly
greater amounts of time in their homes.
NRDC asserts that EPA does not
adequately justify these assumptions in
its petition denial order.
ii. Background. NRDC repeats this
claim verbatim from its petition. In
response to NRDCs petition, EPA
substantially revised its pest strip
exposure assessment. As to exposure
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periods, EPA completely dropped its
prior approach and assessed exposure
assuming a person spent 24 hours per
day in their home in a room containing
a pest strip. (72 FR at 68687).
iii. Denial of hearing. A hearing can
only be based on a genuine issue of
disputed fact. Where a partys factual
allegations are contradicted by the
record, there is no genuine dispute. (57
FR 6667, 6672 (February 27, 1992) (A
hearing must be based on reliable
evidence, not on mere allegations or on
information that is inaccurate and
contradicted by the record.).
iv. Denial of objection. NRDCs
objection is directed at a prior,
superseded risk assessment, not the risk
assessment relied upon in the petition
denial order. Thus, this objection is not
material to this proceeding and is
denied. (See Unit VIII.D.3.c.).
g. Movement of DDVP from
unoccupied areas of the home to
occupied areasi. Objection/hearing
request sub-issue. NRDC claims that
EPA does not have a sufficient basis for
its conclusion that pest strips used in
unoccupied places in a house (garages,
attics, crawl spaces, sheds) will not
migrate to occupied portions of the
house. Thus, NRDC argues EPA does not
have reliable data to reduce or remove
the childrens safety factor.
ii. Background. NRDC made the same
argument in its petition. Additionally,
in the petition, NRDC cited a study with
another pesticide which NRDC claimed
showed that pesticides could migrate
into the house. EPA disagreed with
NRDCs assertion, pointing out that
migration was unlikely unless the
unoccupied portion was connected to
the air exchange system for the house.
EPA also explained in detail why the
study cited by NRDC was not relevant
to DDVP. NRDC did not renew its
arguments based on this study.
iii. Denial of hearing. NRDC has not
alleged and proffered evidence on a
genuine and substantial issue of
disputed fact. NRDC speculates that use
of pest strips in unoccupied areas of a
house may lead to migration of DDVP
residues to occupied portions of the
house. Based on this speculation, NRDC
claims that EPAs exposure assessment
is inadequate because EPA has not
documented that such migration does
not occur. A hearing will not be granted
on the basis of mere allegations or
speculation about what other studies
might show. (See 57 FR 33244, 33248
(July 27, 1992) (NRDC claimed that the
removal of premix batch analysis would
lead to misformulation of selenium in
feeds. A hearing was denied because
NRDC provided no factual information
to support its claim . . . . [A] hearing will
not be granted on the basis of mere
allegations.)).
iv. Denial of objection. NRDCs
objection is denied. Given EPAs
knowledge of the chemical properties of
DDVP, it was reasonable to assume that
DDVP would not migrate from
unoccupied portions of the home to
occupied portions absent some type of
air exchange connection between the
two areas. DDVP is a highly volatile
chemical that quickly degrades once
released to the environment. EPA
reasonably concluded that the low
concentration of airborne DDVP
produced from a DDVP pest strip would
not penetrate the walls of a home in
meaningful amounts.
E. Response to Specific Issues Raised in
Objections and Hearing Requests -
Reliance on Human Study
1. Background. In making its FFDCA
tolerance reassessment decision and
FIFRA reregistration decision for DDVP,
EPA relied upon one human toxicity
study in deriving an acceptable level of
exposure for several exposure scenarios.
The study in question was conducted in
1997 by A.J. Gledhill. In this study, six
male volunteers were administered 7 mg
of DDVP in corn oil (equivalent to
approximately 0.1 mg/kg/day) via
capsule daily for 21 days. Three control
subjects received corn oil as a placebo.
Baseline values for RBC cholinesterase
activity for each study participant were
determined based upon repeated
measurements prior to the
administration of DDVP. After dosing
started, RBC cholinesterase activity was
monitored on days 2, 4, 7, 9, 11, 14, 16,
and 18, and then on day 25 or 28 post-
dosing. Although no toxicity
attributable to administration of DDVP
was reported by the test subjects, mean
RBC cholinesterase activity was
statistically significantly reduced in
treated subjects on days 7, 11, 14, 16,
and 18. These values were 8, 10, 14, 14,
and 16 percent below the pre-dose
mean. (Refs. 15 and 16).
EPAs decision to rely on the Gledhill
study was made pursuant to its Human
Research rule. As explained in Unit
III.D, that rule establishes different
ethical standards for the review of
completed human studies depending on
whether they were initiated before or
after the effective date of the rule on
April 7, 2006. For an intentional human
exposure study such as the Gledhill
study, that was initiated prior to April
7, 2006, EPA is barred, subject to a very
limited exception, from relying on it if
there is clear and convincing evidence
that the conduct of the research was
fundamentally unethical or significantly
deficient with respect to the ethical
standards prevailing at the time the
research was conducted. (40 CFR
26.1704, 1706). Further, the rule limits
the human research that can be relied
upon by EPA to scientifically valid and
relevant data. (40 CFR 26.1701).
Finally, because the Gledhill study was
conducted with the purpose of
identifying or measuring a toxic effect,
EPA is required by the rule to submit its
determination regarding these issues to
an independent expert advisory body
known as the Human Studies Review
Board (HSRB) for review. These
procedures were followed with regard to
the Gledhill study.
Previously, NRDC has challenged the
lawfulness of the Human Research rule.
Following promulgation of the Human
Research Rule, NRDC filed a petition for
judicial review of the rule in the United
States Court of Appeals for the Second
Circuit. (NRDC v. U.S. EPA, No. 06-
0820-ag (2d Cir.)). That case has been
briefed and argued and is awaiting
decision.
NRDC also previously challenged the
scientific merit and ethics of the
Gledhill study in comments to EPA and
to the HSRB. Specifically as to the
HSRB, NRDC filed written comments
prior to the HSRBs review of EPAs
determination regarding the
appropriateness of relying on the
Gledhill study and also presented oral
testimony at the public hearing the
HSRB held with regard to that study.
Subsequently, the HSRB, after taking
into account the comments of NRDC
and others, advised EPA that reliance on
the Gledhill study was consistent with
the Human Research rule. EPA relied
heavily on the analysis of the HSRB in
denying NRDCs petition to revoke
DDVP tolerances. (72 FR at 68675).
In its petition to revoke DDVP
tolerances, NRDC repeated its
arguments made to the HSRB as to why
the Gledhill study does not comply with
the Human Research rule. As support,
NRDC cited to a draft HSRB report on
the Gledhill study, released shortly
before NRDC filed its petition, which
noted scientific and ethical deficiencies
in the study. (Ref. 2 at 26). NRDC did
not acknowledge, however, that despite
identifying deficiencies in the Gledhill
study, the HSRB, in its draft report,
stated its agreement with EPAs
determination that it would be
acceptable to rely on the Gledhill study.
In its objections, NRDC once again
makes the same arguments on the
Gledhill study it made to the HSRB and
in its petition to EPA (including the
misleading reference to a portion of the
draft report of the HSRB). Similar to the
approach taken in the petition, NRDC
does not even acknowledge the
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recommendations made by the HSRB in
its draft and final decisions despite
EPAs explicit reliance on the HSRBs
reasoning in EPAs petition denial
order.
NRDCs objections also include a
challenge to the legality of the Human
Research rule paralleling the case
pending in the Second Circuit.
2. Challenge to the human research
rulea. Objection/hearing request sub-
issue. NRDC argues that to the extent
[its] facial challenge to the [Human
Research] rule is not proper, it is
renewing its arguments regarding the
legality of the rule in its objections. (Ref.
1 at 9-10). The objections incorporate by
reference NRDCs legal briefs filed in the
Second Circuit and its comments filed
on the Human Research rule as support
for this objection. In its legal briefs,
NRDC argues that EPAs rule is
inconsistent with a congressional
funding moratorium in an
Appropriations Act. (Ref. 29). That Act
prohibited EPA from accept[ing],
consider[ing] or rely[ing] on third-party
intentional dosing human toxicity
studies for pesticides . . . until [EPA]
issues a final rulemaking on this
subject. (Public Law 109-54, sec. 201,
119 Stat. 499, 531 (August 2, 2005)).
According to NRDC, EPA did not
comply with this legislations
requirement that the EPA human testing
rule bar testing on pregnant women,
infants and children and be consistent
with the principles in a 2004 National
Academy of Sciences Report and the
Nuremburg Code on human
experimentation. (Ref. 29 at 23). NRDC
did not specifically lay out the
arguments in its legal briefs in its
objections other than to include a
summary of some of the principles of
the Nuremberg Code. (Ref. 1 at 11-12).
Similar arguments are made in NRDCs
comments on EPAs proposed Human
Research rule. (Ref. 30).
b. Background. Arguments concerning
the legality of the Human Research Rule
were not contained in the petition.
c. Denial of hearing request. In this
sub-issue, NRDC presents, by reference,
various arguments that the Human
Research rule is not consistent with
congressional legislation bearing on the
rule. These arguments raise questions
regarding the proper interpretation of
statutory language and hearings are not
appropriate on such issues. (40 CFR
178.32(b)(1)).
d. Denial of objection. To the extent
this matter is not resolved by the
Second Circuit and NRDC has standing
to challenge a rule whose primary
concern is the [p]rotection of the
health and safety of human test
subjects, (Ref. 1 at 15), EPA denies
NRDCs objections to the legality of the
Human Research rule. EPA believes the
Human Research rule is fully consistent
with the Appropriations Act and EPA
has fully explained the basis for this
conclusion in the rulemaking record
(EPAHQOPP20030132) and its
legal brief filed in the Second Circuit
proceeding. (Ref. 31).
3. Challenge to reliance on the
Gledhill Studya. Statistical power -
too few subjects to detect an effecti.
Objection/hearing request sub-issue.
NRDC objects that the number of test
subjects in the Gledhill study was low
and thus there are statistical issues with
extrapolating from the results of the
Gledhill study to the general human
population. (Ref. 1 at 13). In part, NRDC
frames this argument as the Gledhill
study lacks statistical power and
NRDC references four published letters
or articles in support of this claim. (Ref.
1 at 15). Further, NRDC claims that the
statistical power issue is particularly
important for studies such as the
Gledhill study which measure
cholinesterase inhibition because of the
variability among individuals of
cholinesterase inhibition over time.
According to NRDC, the range of
variability both between and for the
individual test subjects means that even
greater than the customary number of
test subjects would be required to
permit adequate statistical power to
detect effects caused by the test
substance above background
variations. (Ref. 1 at 13). As evidence
of this cholinesterase inhibition
variability in humans, NRDC cites to
another human study by Gledhill (MRID
# 4428802 rather than MRID #
44248801).
NRDCs objection here appears to be
confusing two separate issues: (1) did
the Gledhill study have sufficient
statistical power to detect an effect
caused by DDVP; and (2) does the
Gledhill study contain sufficient data to
reliably estimate a safe dose for humans.
The first issue is addressed in this Unit
and the second in Unit VIII.E.3.b.
ii. Background. NRDCs objection
repeats assertions made in its petition to
revoke DDVP tolerances and its
comments on the DDVP IRED. (Ref. 2 at
26-27; Ref. 23 at 14-17). EPA rejected
NRDCs claims about statistical power,
explaining that [a]lthough as a general
matter more subjects would provide
greater statistical power, in this case
the use of 6 to 9 subjects with the
appropriate statistical methodology is
acceptable to EPA because a positive
response was seen. (72 FR at 68675).
EPA also noted that the variability
within the cholinesterase inhibition of
the tested subjects is not large,
particularly since the percentage
inhibition in all instances was at the
marginal end of the range. (Id.).
iii. Denial of hearing. A hearing is not
required on NRDCs statistical power
claim because the concept of statistical
power is simply not applicable to the
conclusions EPA drew with regard to
the Gledhill study and thus this issue is
not material to NRDCs requested relief.
Further, the evidence proffered by
NRDC would not, if established, resolve
this issue in NRDCs favor.
To understand EPAs ruling here,
some basic definitional information on
the concept of statistical power and
how it applies in the context of toxicity
studies may be helpful. Toxicity testing
is designed to test the veracity of the
hypothesis that there will be no
differences in health outcomes between
treated and untreated (control) subjects.
Statisticians refer to this hypothesis as
the null hypothesis. The alternative
hypothesis is that there will be a
difference between treated and control
subjects. In general terms, statistical
power measures the probability that a
toxicological study will find a
treatment-related adverse health
outcome when there is a treatment-
related adverse effect to be found. (Ref.
32 at 125 and n.144). In the language of
a statistician, statistical power measures
the probability of rejecting the null
hypothesis when the alternative
hypothesis is right. (Id.). A study with
a statistical power value of near one (1)
would have a very high chance of
(properly) rejecting the null hypothesis
if the alternative hypothesis is true,
whereas a power value close to zero (0)
would indicate that there is little chance
that the study will identify any true
adverse health outcomes occurring as a
result of treatment.
Statistical power can also be used to
calculate the probability that the study
will falsely find that there is no
difference in the health outcomes
between treated and control subjects,
that is, whether the study will falsely
affirm the null hypothesis. The
probability of such a false negative, is
determined by subtracting the statistical
power of a study from one (1). (Id.).
Thus, the chance that a study will result
in a false negative is directly related to
the chance that the study will identify
any effects present. For example, if a
study has low statistical power, there
will be a low probability that the study
will find an effect if there is one and a
high probability that the study will
falsely affirm that there is no effect.
Statistical power, therefore, is a
important tool in designing studies to
ensure that effects from treatment are
not missed and may play a role in
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evaluating completed studies that
confirm the null hypothesis to
determine the probability that the null
hypothesis was not falsely affirmed (i.e.,
a false negative).
If analysis of a toxicological study
shows that there are treatment-related
effects (i.e., the null hypothesis of no
treatment-related effect is rejected), then
the question of the statistical power of
the study becomes largely irrelevant.
Put another way, if a study shows a
positive outcome, the probability that
the study might have produced a false
negative becomes a moot point.
Importantly, with the Gledhill study,
the null hypothesis of no treatment-
related effect was rejected: that is, the
HSRB and EPA concluded that there
was a significant difference in
cholinesterase inhibition both between
controls and DDVP-treated subjects and
between the inhibition levels pre- and
post-treatment of the DDVP-treated
subjects.
With that background, the scientific
papers cited by NRDC can be more
easily followed. First, NRDC cites a one-
page letter to the Environmental Health
Perspectives journal which was co-
authored by Jennifer Sass, a NRDC
senior scientist, and a subsequent letter,
again co-authored by Sass, that
responded to various letters expressing
a different viewpoint. (Ref. 1 at 15, and
Refs. 33 and 34). The topic of both Sass
letters is nicely captured by the title
attached to the first letter: Industry
Testing of Toxic Pesticide on Human
Subjects Concluded No Effect, Despite
the Evidence. (Ref. 33 ).
The first letter discusses the DDVP
Gledhill study and a second human
study involving a different pesticide.
With regard to the DDVP Gledhill study,
Sass criticizes Amvacs analysis of that
study. Amvac had concluded that the
Gledhill study demonstrated a NOAEL
arguing that the cholinesterase
inhibition effects seen at the single dose
in that study were not biologically
significant. Sass counters that the only
biological end point measured in the
study was cholinesterase inhibition, and
this was significantly inhibited. (Ref.
33 at A150). As to statistical power, Sass
claims that studies involving only a few
human subjects often lack enough
subjects to provide adequate statistical
power to detect an effect if it is
present. (Id.).
The second letter repeats this latter
assertion and claims that the statistical
power of human studies then available
have such low statistical power that
they practically guarantee[d] a finding
of no effect. (Ref. 34 at A340). Sass
then returns to the Gledhill study and
notes with approval EPAs conclusion
that that study demonstrated a LOAEL:
the U.S. Environmental Protection
Agency (EPA) rejected AMVACs
interpretation of the results, instead
concluding that the reduction in RBC
cholinesterase activity was considered
by the Hazard ID [identification]
Committee to be biologically significant,
and the dose tested was considered to
be a lowest observed effect level
(LOEL). (Id.). EPAs reversal of the
Amvac conclusion is cited by the letter
as illustrative of bias by chemical
manufacturers in the design and
interpretation of studies.
For at least two reasons, these letters
neither demonstrate the materiality of
NRDCs statistical power claims nor
constitute a sufficient evidentiary
proffer. First, although they do contain
allegations about low statistical power
of human studies with low numbers of
subjects, they only address the question
of whether such studies can detect an
effect even if an effect is present (i.e.,
are they likely to falsely affirm the null
hypothesis that there are no treatment-
related adverse effects). In the DDVP
Gledhill study, however, EPA and the
HSRB concluded that the study did
identify an adverse effect. Accordingly,
the letters have little relevance to EPAs
ultimate finding with regard to the
Gledhill study. Second, these letters do
not challenge EPAs analysis of the
Gledhill study - rather, they ratify it.
Thus, the letters do not proffer
evidence, which would, if established,
resolve a material issue in NRDCs favor.
(See 57 FR 33244, 33246 (July 7, 1992)
(Studies cited by NRDC do not provide
a basis for the hearing because they
support the [FDA] conclusion in
question.)).
NRDC also cites two articles by Alan
Lockwood. One is an article in the
American Journal of Public Health
discussing ethical and scientific
considerations with regard to six human
toxicology studies, including the
Gledhill study at issue in this
proceeding. (Refs. 1 at 15; and 35). The
second is a one-page summary of the
earlier article that was published in The
Environmental Forum. (Ref. 36). The
first article contains the following
paragraph discussing statistical power:
A power analysis to define the proper size
of study group(s) is an essential part of the
design. If too many participants are enrolled,
the excess will be subjected to unnecessary
risk. If too few are enrolled, the investigator
risks erroneous acceptance of the null
hypothesis. Underpowered studies are
inconclusive, and all participants in an
underpowered study will have been exposed
to risk unnecessarily. All of these studies
were underpowered.
(Ref. 35 at 1912). There is little to no
explanation provided in the article for
the underpowered conclusion other
than the notation that the six studies
involved young healthy adults. There is
little, if any, discussion of the Gledhill
DDVP study at issue in this proceeding.
The summary article adds nothing new
to the longer article.
Like the Sass letters, therefore, the
Lockwood articles do not constitute a
proffer of evidence that if established
would resolve a material issue in favor
of NRDC. Not only do they not proffer
any evidence, they focus on an issue not
involved here - do human studies, such
as the Gledhill study, have sufficient
statistical power to avoid erroneous
acceptance of the null hypothesis. Both
EPA and the HSRB rejected the null
hypothesis as to the Gledhill study (i.e.,
an adverse effect on the treated subjects
was identified). Additionally, these
articles do not advance specific
evidence, or even arguments,
concerning the Gledhill study itself.
(See 53 FR 53176, 53179-53180
(December 30, 1998) (a general assertion
in a letter to Science magazine is not
basis for a hearing); 68 FR 46403, 46405-
46406 (August 5, 2003) (a hearing was
denied because the cited studies only
contained equivocal statements
supporting the objectors position)).
NRDC also cites the variable level of
cholinesterase inhibition within
individuals as supporting its statistical
power argument. NRDC references a
different DDVP human study by
Gledhill (MRID # 44248802) to show
variability in cholinesterase inhibition.
This argument and these data also do
not justify a hearing.
Initially, it must be noted that EPA
cannot consider this other Gledhill
study because both EPA and the HSRB
concluded it was without scientific
merit and therefore does not qualify for
EPA consideration under the Human
Research rule. (Ref. 21 at 42-43).
Whether or not the aspect of the study
cited by NRDC is implicated by this
conclusion has not been evaluated;
nonetheless, EPA does not disagree with
NRDCs assertion that individual
humans have variable levels of
cholinesterase inhibition and thus this
is not a disputed issue of fact. Neither
does EPA dispute that variability of
cholinesterase inhibition should be
taken into account in considering
statistical power and in analyzing the
results of a human study.
However, as discussed above,
statistical power is no longer a relevant
concept once EPA has concluded that a
toxicity study shows that the pesticide
has an adverse effect on treated subjects.
Statistical power is a tool used to
evaluate the possibility of accepting
false negatives. Moreover, the variability
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of cholinesterase inhibition in subjects
is also a factor relating to a concern with
false negatives. Normal variation in the
responses of individual test subjects
may mask treatment-related effects
leading to a false conclusion that there
were no treatment-related effects.
Finally, NRDCs claims on variability
amount to no more than a mere
allegation that the existence of variable
rates of cholinesterase inhibition
indicate a flaw in the Gledhill study and
EPAs reliance on it. Without an
evidentiary proffer, however, a hearing
is not appropriate.
iv. Denial of objection. NRDC has
misconstrued the concept of statistical
power. It has little relevance in
circumstances where a positive effect is
found in a toxicological study. NRDCs
objection that EPA should not have
relied upon the Gledhill study because
it lacked statistical power is denied.
b. Too few test subjects to establish a
NOAELi. Objection/hearing request.
NRDC objects to reliance on the Gledhill
study claiming that because it only
involved six treated test subjects it
cannot support the establishment of a
reliable NOAEL or dose response curve
. . . . (Ref. 1 at 13).
ii. Background. NRDCs claim was
contained in both its petition and its
comments on the IRED. (Refs. 1 at 26;
and 23 at 15). In its petition denial
order, EPA responded to these claims by
concurring with the HSRBs conclusion
that the Gledhill study was sufficiently
robust for developing a Point of
Departure for estimating dermal,
incidental oral, and inhalation risk from
exposure to DDVP in a single chemical
assessment. (72 FR at 68675 (quoting
HSRB Report)). The HSRB found the
study to be robust based on the
following attributes: the repeated dose
approach which allowed examination of
the sustained nature of RBC
cholinesterase inhibition; robust
analysis of RBC cholinesterase
inhibition both in terms of identifying
pre-treatment levels and consistency of
response within and between subjects;
and the observation of a low, but
statistically significant RBC
cholinesterase inhibition response.
(Id.; Ref. 21 at 39-41).
iii. Denial of hearing. NRDC has not
met the requirements for a hearing on
this sub-issue. First, NRDC has proffered
no evidence that the six treated subjects
in the Gledhill subject were too few for
EPA to use data from that study as a
Point of Departure. Rather, NRDC does
no more than state [w]e are aware of
no statistical test which would support
EPAs use of the Gledhill data. (Ref. 1
at 13). As EPAs regulations make clear,
a mere denial of an EPA position is
not sufficient to satisfy the standard for
granting a hearing. (40 CFR
178.32(b)(2)). Second, NRDC does not
confront the reasoning of the HSRB,
which was adopted by EPA, for why the
data from the Gledhill study are
sufficiently robust to justify their use as
a Point of Departure. This failure to
challenge the basis of EPAs petition
denial affects the materiality of the
objection and hearing request. Even if
NRDC could demonstrate in a hearing
that generally more test subjects are
needed to derive a Point of Departure
for a RfD/PAD, that evidence would not
address the specific factors in the
Gledhill study that EPA and the HSRB
found convincing on this question. (See
Unit VIII.D.4.a.iii).
iv. Denial of objections. EPA does not
agree with NRDCs undocumented
assertion that the Gledhill study does
not provide an appropriate Point of
Departure for assessing DDVP risk. EPA,
and the HSRB, found that there were
several features of the study and the
statistical analysis of the study that
made it sufficiently robust for
developing a Point of Departure . . . .
(72 FR at 68675). Important factors cited
by the HSRB, and adopted by EPA,
included: (1) the study design which
involved repeated dosing and repeated
measurement of cholinesterase effects in
individuals; (2) extensive pre-dosing
measurement of the test subjects
cholinesterase inhibition levels which
showed consistency both within and
between individual test subjects; and (3)
the clear study results which showed a
statistically significant effect on
cholinesterase inhibition was found
(both between controls and treated
subjects and between the tested
subjects pre- and post-dosing levels)
that was at or near the lowest level that
could be distinguished from baseline
values. (72 FR at 68675). Further, as
EPA noted in its petition denial order,
a similar number of test subjects (four
per sex) are recommended for a
toxicology study in non-rodents (usually
the dog) routinely required for pesticide
risk assessment. (72 FR at 68675).
In response to EPAs and the HSRBs
conclusions as to the Gledhill study,
NRDC does little more than repeat its
allegation that the Gledhill study was
underpowered. NRDC does respond to
EPAs reference to the chronic dog
study, alleging without providing any
basis that that study is underpowered,
and claiming that EPA rarely relies
upon that study. (Ref. 1 at 13). NRDC
is incorrect. The chronic dog study was
added to EPAs testing requirement
regulations in 1984 and was included in
the revised regulations re-promulgated
just last year, although the length of the
study was shortened from 1 year to 13
weeks. (72 FR 60934, 60940-60941
(October 26, 2007); 49 FR 42881
(October 24, 1984)). As a standard study
required in evaluating pesticides used
on food, the chronic dog study would
have been considered and relied upon
in virtually every one of the roughly
10,000 FFDCA tolerance reassessments
conducted in the 10 years following
enactment of the FQPA. (Ref. 37). If, by
rarely relied upon, NRDC means the
results from chronic dog are rarely used
as a Point of Departure, NRDC is still
incorrect. For example, a cursory review
of rules establishing new tolerances in
2005 showed at least eight instances in
which the Point of Departure for
assessment of a pesticides risk was
based on the chronic dog study. (70 FR
77363, 77366 (December 30, 2005)
(hexythiazox); 70 FR 74688, 74690
(December 16, 2005) (bifenazate); 70 FR
55740, 55743 (September 23, 2005)
(fenpropathrin); 70 FR 55752, 55757
(September 23, 2005) (amicarbazone); 70
FR 55761, 55764 (September 23, 2005)
(pyridaben); 70 FR 54640, 54644
(September 16, 2005) (fluoxastrobin); 70
FR 53944, 53946 (September 13, 2005);
70 FR 51615, 51617 (August 31, 2005)
(halosulfuron-methyl). A retrospective
analysis performed by EPA in 2005 also
showed that 116 out of 304 chronic RfDs
for pesticides was based on the chronic
dog study. (Ref. 38). Finally, another
example somewhat closer to home
would be DDVP, where the NOAEL
from the chronic dog study is used as
the Point of Departure in assessing
chronic dietary risk. (Ref. 3 at 132).
Further, EPAs recommendation for
four test subjects per sex per dose in the
sub-chronic and chronic non-rodent
(dog) study is widely followed. The
FDA has a similar recommendation for
conducting non-rodent studies of sub-
chronic and chronic duration as does
the Organisation for Economic Co-
operation and Development (OECD),
Canada which has accepted the OECD
guideline on the sub-chronic and
chronic non-rodent (dog) study, and the
European Commissions Joint Research
Centre of the European Union. (Refs. 39,
40, 41, 42, and 43).
c. Adult males onlyi. Objection/
hearing request sub-issue. NRDC objects
to the Gledhill study because it
included as test subjects only adult
males. (Ref. 1 at 14). NRDC claims that
adult males are biologically
unrepresentative of the human
population.
ii. Background. NRDCs objection is
drawn verbatim from its comments on
the DDVP IRED. EPA responded to this
argument by pointing out that no sex
differences were observed in the
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comparative cholinesterase studies. (72
FR at 68675). EPA also found no age-
related differences in cholinesterase
inhibition. (72 FR at 68694).
iii. Denial of hearing. A hearing is
denied on this sub-issue because there
is no disputed factual matter for
resolution at a hearing. There is no
dispute concerning the subjects in the
Gledhill study - they were adult males.
Thus, the only question is whether a
human study using only adult males
meets the regulatory requirement of
scientifically valid and relevant data.
(40 CFR 26.1701). Because NRDC has
proffered no evidence regarding the
representativeness of adult males to the
general population, this question
requires the application of a legal
standard to undisputed facts. Hearings
are not appropriate on questions of law
or policy. (40 CFR 178.32(b)(1)). FDA
has repeatedly confirmed that the
application of a legal standard to
undisputed facts is a question of law for
which a hearing is not required. (See,
e.g., 68 FR 46403, 46406 n.18, 46408,
46409 (August 5, 2003) (whether facts in
the record show there is a reasonable
certainty of no harm is a question of
law; whether a particular effect is a
harm is a question of law)).
NRDCs hearing request is also flawed
because NRDC does not object to the
basis EPA asserted in its petition denial
for concluding that the Gledhill study
provided scientifically valid data
despite its use of only adult male
subjects. As noted above, EPA thought
representativeness concerns were
addressed by the fact that animal
studies with DDVP showed no
differences in sensitivities between
males and females and adults and the
young. NRDC, however, has not
challenged and proffered evidence to
rebut this conclusion nor has NRDC
challenged or proffered evidence to
rebut EPAs analysis of the underlying
data. Rather, NRDC just repeats its
assertions regarding the
unrepresentativeness of adult males
generally. This failure to challenge the
basis of EPAs petition denial affects the
materiality of the objection and hearing
request. Even if NRDC offers evidence to
show sex- and age-related sensitivities
in the population to some toxicants,
such evidence would not rebut the
DDVP-specific data on sensitivity. (53
FR 53176, 53191 (December 30, 1988)
(FDA denied a hearing request noting
that given FDAs prior conclusion that
the studies relied upon by the objector
were unreliable, the burden shifted to
[the objector] to maintain the viability of
its objection by proffering some
information that called into question the
agencys conclusion on this matter.)).
iv. Denial of objection. EPA concludes
that it was reasonable to use the
Gledhill study despite that fact that it
only examined adult males given that
the animal toxicology data on DDVPs
cholinesterase effects consistently
showed no differences between males
and females and adults and the young.
Multiple studies involving adult
animals yielded consistent
cholinesterase inhibition results in
males and females. (Ref. 3 at 124-126).
Similarly, Benchmark Dose Method
analysis of the developmental
neurotoxicity data did not demonstrate
any substantial numerical differences in
[Benchmark Dose Method Level] values
for either RBC or brain cholinesterase
between young and adult animals. (72
FR at 68694).
d. Plasmai. Objection/hearing
request. NRDC objects that the Gledhill
study is unreliable because it measured
only RBC cholinesterase inhibition and
not plasma cholinesterase inhibition.
NRDC claims that measuring plasma
cholinesterase might have reduced the
variability measured in RBC
cholinesterase.
ii. Background. In its petition, NRDC
argued that plasma cholinesterase
should have been measured because it
might be a more sensitive indicator of
DDVPs cholinesterase effects. EPA
responded to the petition by noting that
RBC cholinesterase is the Agencys
preferred cholinesterase inhibition
endpoint as compared to plasma
cholinesterase. (72 FR at 68676). EPA
explained that [s]ince the red blood
cell contains only acetylcholinesterase,
the potential for exerting effects on
neural or neuroeffector
acetylcholinesterase may be better
reflected by changes in red blood cell
acetylcholinesterase than by changes in
plasma cholinesterases which contain
both butyrylcholinesterase and
acetylcholinesterase in varying ratios
depending upon the species. (Id.). EPA
concluded that information on a less
preferred endpoint adds little
meaningful information. (Id.).
iii. Denial of hearing. NRDC proffers
no evidence in support of its allegation
that collection of plasma cholinesterase
inhibition data would be useful in
limiting the variability seen in the RBC
cholinesterase inhibition data. Hearings
will not be granted on mere allegations.
(40 CFR 178.32(b)(2)). Further, given
EPAs conclusion that the variability in
RBC cholinesterase inhibition in the test
subjects was accounted for by pre- and
post-treatment measurement, this issue
is not material to resolution of NRDCs
claim. Finally, to the extent NRDC is
advocating reliance on plasma
cholinesterase inhibition data over RBC
cholinesterase inhibition data that is a
policy issue and hearings will not be
held as to policy issues. (40 CFR
178.32(b)(1)).
iv. Denial of objection. EPAs well-
established policy when evaluating
blood cholinesterase inhibition is to use
RBC cholinesterase data in preference to
plasma cholinesterase. (Ref. 10 at 32).
EPAs reasoning here is straightforward.
Blood cholinesterase data is used as an
indicator of possible effects on
acetylcholinesterase in the peripheral
nervous system. RBC cholinesterase is
composed entirely of
acetylcholinesterase, whereas plasma
cholinesterase is a mixture of
acetylcholinesterase and
butyrylcholinesterase, a compound
somewhat similar to
acetylcholinesterase in structure that
nonetheless is different in important
ways which often result in it having
binding affinities to anticholinesterase
agents as well as other characteristics
that are quite different from those of
acetylcholinesterase. (Id. at 32). The
ratio of acetylcholinesterase to
butyrylcholinesterase in plasma differs
by species; in humans, plasma is
overwhelmingly butyrylcholinesterase
with a ratio of butyrylcholinesterase to
acetyl cholinesterase of 1,000:1. (Id.)
It is preferable to have both RBC and
plasma cholinesterase data from a study
because effects in the RBC may be non-
existent, equivocal, or fail to establish a
clear-dose response pattern. In those
circumstances, plasma cholinesterase
inhibition data may serve as a Point of
Departure or may aid in the
interpretation of the RBC data,
particularly when extrapolating animal
data to humans. In the Gledhill study,
however, the robust RBC cholinesterase
sampling approach in humans (multiple
pre- and post-dosing samples and
sampling after repeat dosing) as well as
the clear pattern on RBC cholinesterase
inhibition means the absence of plasma
cholinesterase inhibition data is of little
to no consequence.
In its objections NRDC claims that
plasma cholinesterase inhibition data
might have reduced somewhat the
variability in the RBC cholinesterase
data. EPA disagrees both because
plasma cholinesterase in humans is
overwhelmingly composed of
butyrylcholinesterase not
acetylcholinesterase, and because the
robust sampling plan in the Gledhill
study well-characterized the RBC
cholinesterase variability. For all of
these reasons, NRDCs objection on this
issue are denied.
e. Controls over environmenti.
Objection/hearing request sub-issue.
NRDC argues that because there were
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not controls over the Gledhill test
subjects exposure to environmental
factors which might affect
cholinesterase inhibition (e.g., ingestion
of pharmaceuticals), the results of
Gledhill study might be caused
environmental factors and are thus
invalid.
ii. Background. This claim is
contained in NRDCs petition and was
not specifically addressed by EPA in the
petition denial order other than through
its acceptance of the HSRBs analysis.
iii. Denial of hearing request. The
control measures used in the Gledhill
study are set forth in the study report
and are not in dispute. The only
question is whether these control
measures make the Gledhill study
scientifically invalid and thus not in
compliance with EPA regulations. Legal
questions such as this are not
appropriate for a hearing. (40 CFR
178.32(b)(1); see, e.g., 68 FR 46403,
46406 n.18, 46408, 46409 (August 5,
2003) (whether facts in the record show
there is a reasonable certainty of no
harm is a question of law and thus is not
a hearing issue; whether a particular
effect is a harm is a question of law
not of fact and a hearing will not be held
on issues of law)). Additionally, NRDC
proffers no evidence regarding the effect
of the studys control measures other
than speculation about how
environmental factors might have
affected the study. A hearing will not be
granted on the basis of mere allegations
or speculation. (40 CFR 178.32(b)(2); (57
FR 6667, 6671 (February 27, 1992)).
Finally, NRDCs argument here is
immaterial to its claim. As EPA explains
below in denying this objection, the lack
of control measures would only be an
issue if NRDC is arguing that EPA has
wrongfully concluded that the Gledhill
study has not shown a measurable effect
in the treated subjects.
iv. Denial of objection. NRDCs
objection here might warrant some
consideration if the study results had
shown no pattern and EPA had
concluded that the study established a
NOAEL for DDVP. In those
circumstances, it could be argued that
any effects from DDVP exposure may
have been masked by other factors.
However, the study results here showed
a clear and consistent pattern of
marginal effects on RBC cholinesterase
inhibition in connection with DDVP
dosing. Given these results and the fact
that the test subjects were pre-screened
for environmental factors that might
affect study results (e.g., regular use of
pharmaceuticals; excessive alcohol
consumption; exposure to
organophosphurus compounds),
NRDCs speculation that environmental
factors might have affected the study
results is without merit.
f. Consenti. Objection/hearing
request sub-issue. NRDC asserts that
informed consent was not obtained from
the Gledhill test subjects because the
consent form for the experiment
identified DDVP as a drug. (Ref. 1 at
14). NRDC claims that EPA has ignored
this issue. NRDC cites an EPA
memorandum dated March 16, 2006,
examining the ethics of the Gledhill
study and asserts that it fails to
mention [the informed consent] issue
when it concludes that the study was
not fundamentally unethical. (Id. at
15). NRDC argues that describing DDVP
as a drug constitute[s] fundamentally
unethical actions by any reasonable
understanding of that term. (Id.).
ii. Background. This objection comes
verbatim from NRDCs comments on the
DDVP IRED. EPA responded to this
issue in its denial of NRDCs petition by
adopting the HSRBs conclusion that
informed consent was obtained. EPA
explained that [t]he HSRB reasoned
that references to DDVP as a drug did
not vitiate informed consent because
the consent materials clearly advised
subjects that this was a study involving
consuming an insecticide. (72 FR at
68675).
iii. Denial of hearing. It is not clear
from NRDCs objections whether NRDC
is challenging EPAs conclusion on the
ethics of consent issue based on (1) an
alleged failure of EPA to address this
question; or (2) the legal proposition
that identification of a pesticide as a
drug constitute[s] fundamentally
unethical actions by any reasonable
understanding of that term. In either
case, a hearing is not appropriate on
NRDCs objection.
First, NRDCs allegation that EPA did
not address the consent issue does not
present a genuinely-disputed issue of
fact. It is plain on the face of EPAs
petition denial order, that EPA adopted
the reasoning of the HSRB on why
references on the consent form to DDVP
as a drug do not constitute clear and
convincing evidence that the Gledhill
study is fundamentally unethical. (72
FR at 68675). After summarizing the
decision of the HSRB on the consent
issue (see quoted language in Unit
VIII.E.3.f.ii. above), EPA stated: EPA
adopts the HSRBs reasoning and finds
it persuasive in rejecting NRDCs
arguments concerning why the Gledhill
study should not be relied upon. (Id.).
NRDCs argument that EPA offered no
explanation is based on a memorandum
that predates and is superseded by
EPAs denial of NRDCs petition. The
March 16, 2006 memorandum was
finalized more than 20 months before
issuance of the DDVP petition denial
order and the order contains EPAs
rationale on the consent issue. As noted
earlier in Unit VIII.D.3.c., when an
objector to a section 408(d)(4)(iii) order
challenges an EPA conclusion that has
been superseded by the section
408(d)(4)(iii) order, the objector has not
raised a live controversy as to a material
issue. (See 53 FR 53176, 53191
(December 30, 1988) (where FDA
responds to a comment in the final rule,
repetition of the comment in objections
does not present a live controversy
unless the objector proffers some
evidence calling FDAs conclusion into
question)). Moreover, objections, and
hearing requests on objections, may
only be filed as to a section 408(d)(4)(iii)
order or other statutorily-specified
action. (21 U.S.C. 346a(g)(2)(A)).
Second, the informed consent
question as to the Gledhill study is a
legal/policy issue not a factual one.
There are no disputed facts regarding
the consent form. The consent form
used in the Gledhill study is set forth in
the study report and NRDC has not
proffered any other evidence bearing on
consent. Accordingly, the only question
is the legal/policy one of whether use of
the Gledhill study consent form is
clear and convincing evidence that
the Gledhill study was fundamentally
unethical and thus not in compliance
with EPA regulations. (40 CFR 26.1704).
In fact, NRDC has framed the consent
issue as a legal question, arguing that
the undisputed reference to DDVP as a
drug in the consent form for the Gledhill
study constitute[s] [a] fundamentally
unethical action[] by any reasonable
understanding of that [regulatory]
term. (Ref. 1 at 15). Further, to support
this legal argument, NRDC turns to other
legal authorities arguing that [t]he
requirement for obtaining informed
consent is at the core of the [40 CFR]
Part 26 regulations and FIFRA section
12(a)(2)(P), and [v]iolation of these
regulations, laws and international
standards in the design and conduct of
human studies is fundamentally
unethical. (Id.). Hearings are not
appropriate on questions of law or
policy. (40 CFR 178.32(b)(1)).
Finally, a hearing is not appropriate
on this sub-issue because NRDCs
objection does not respond to EPAs
conclusion, based on the HSRBs
reasoning, as to why there was not a
problem with consent in the Gledhill
study. As such, NRDCs objection on
this point is nothing more than a general
denial of EPAs conclusion and a
hearing cannot be justified on this basis.
(40 CFR 178.32(b)(2)).
iv. Denial of objection. NRDC has
offered no response to EPAs petition
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denial order which incorporated the
HSRBs reasoning as to why the
references to DDVP as a drug did not
constitute clear and convincing
evidence that the Gledhill study was
fundamentally unethical. Specifically,
NRDC does not address the HSRBs
conclusion, adopted by EPA, that the
test subjects consent was informed
because the consent materials clearly
advised subjects that this was a study
involving consuming an insecticide.
(Ref. 21 at 46). Thus, EPA denies the
objection.
g. Protection of health of the test
subjectsi. Objection/hearing request
sub-issue. NRDC differs with EPAs
conclusion that there was not clear and
convincing evidence that the Gledhill
study was rendered fundamentally
unethical by the failure of the test
conductors to retest the subjects until
their cholinesterase inhibition levels
returned to baseline levels. (Ref. 1 at 14-
15). According to NRDC, EPA
acknowledged, in a March 16, 2006,
memorandum, that the failure to retest
was inconsistent with the standards in
the Declaration of Helskinki by showing
a lack of concern for the safety of the
test subjects. (Id.). NRDC claims that
EPA has offered no explanation for why
it concluded that the Gledhill study was
not fundamentally unethical despite
this inconsistency with the Declaration
of Helsinki. (Id. at 15).
ii. Background. This objection is
adopted verbatim from the comments
that NRDC filed on the IRED. (Ref. 23 at
16-17). In responding to this claim, EPA
adopted the reasoning of the HSRB that
[d]eficiencies in monitoring of subjects
were found not to provide clear and
convincing evidence that the study was
ethically deficient by subjecting the test
subjects to the threat of serious harm
because prior studies by this researcher
involving higher doses had only
invoked minimal responses. (72 FR at
68675).
iii. Denial of hearing. As with the
consent issue, it is not clear from
NRDCs objections whether NRDC is
challenging EPAs conclusion on the
ethics of not retesting based on (1) an
alleged failure of EPA to offer an
explanation for its conclusion; or (2) the
legal proposition that a study that is
inconsistent with the Declaration of
Helsinki is necessarily fundamentally
unethical under the Human Research
rule. In either case, a hearing is not
appropriate on NRDCs objections.
If NRDC is challenging EPAs alleged
lack of an explanation, then NRDC has
failed to identify a genuinely-disputed
issue of fact. As with the consent issue,
EPA, in its petition denial order,
summarized and then adopted the
reasoning of the HSRB on why the
failure to retest does not constitute clear
and convincing evidence that the
Gledhill study is fundamentally
unethical. (72 FR at 68675) (see quoted
language in Unit VIII.E.3.g.ii. above).
NRDCs argument that EPA offered no
explanation is based on a memorandum
that predates and is superseded by
EPAs denial of NRDCs petition. For the
reasons set forth in Unit VIII.D.3.c and
Unit VIII.E.3.f.iii., an objection and
hearing request as to a section
408(d)(4)(iii) order based on a
memorandum superseded by the section
408(d)(4)(iii) order does not constitute a
live controversy on an issue material to
the section 408(d)(4)(iii) order and,
arguably, not even a valid objection
under section 408(g)(2)(A). (21 U.S.C.
346a(g)(2)(A); see 53 FR 53176, 53191
(December 30, 1988) (where FDA
responds to a comment in the final rule,
repetition of the comment in objections
does not present a live controversy
unless the objector proffers some
evidence calling FDAs conclusion into
question)).
If NRDC is challenging the substance
of EPAs conclusion on the ethics of the
Gledhill study, this objection also does
not warrant a hearing because NRDC is
making no more than a legal or policy
argument. There is no dispute with
regard to what post-testing was
performed as to the Gledhill subjects.
NRDC admits as much. (Ref. 1 at 15
(There is nothing in the [EPA] memo
that suggests that there is any
uncertainty or controversy about what
the various study documents said or
what was done in the study in relation
to this ethical inconsistency with the
Helsinki Declaration. . . .
Notwithstanding the clear facts of the
case [regarding retesting] . . . .). The
only question is whether the failure to
test subjects until cholinesterase
inhibition levels returned to baseline is
clear and convincing evidence that
the Gledhill study was fundamentally
unethical. (40 CFR 26.1704). Like the
consent issue, NRDC, itself, has framed
the issue as involving a legal question
as to which there is only one answer.
According to NRDC, these failings [as
to retesting subjects and consent] both
constitute fundamentally unethical
actions by any reasonable
understanding of that term. (Ref. 1 at
15). Further, NRDC argues categorically
that [v]iolation of . . . international
standards in the design and conduct of
human studies is fundamentally
unethical. (Id.). This is a legal/policy
determination regarding application of
an EPA regulatory standard and the
standards of the Declaration of Helsinki
to undisputed facts. Certainly, NRDC
has proffered no genuine factual issue to
be resolved at a hearing. Hearings are
not appropriate on questions of law or
policy. (40 CFR 178.32(b)(1)).
Finally, a hearing is not appropriate
on this sub-issue because NRDCs
objection does not respond to EPAs
conclusion, based on the HSRBs
reasoning, as to why the failures in
monitoring of subjects following the
conclusion of dosing did not amount to
clear and convincing evidence that the
study was fundamentally unethical. As
such, NRDCs objection on this point is
nothing more than a general denial of
EPAs conclusion and a hearing cannot
be justified on this basis. (40 CFR
178.32(b)(2)).
iv. Denial of objection. NRDC has
offered no response to EPAs petition
denial order which incorporated the
HSRBs reasoning as to why the failure
to retest subjects did not constitute clear
and convincing evidence that the
Gledhill study was fundamentally
unethical. Specifically, NRDC does not
address the HSRBs conclusion, adopted
by EPA, that the lack of retesting was
not fundamentally unethical because
prior studies by this researcher
involving higher doses had only
invoked minimal responses. (72 FR at
68675). Thus, NRDCs objection on this
point is denied.
F. Summary of Reasons for Denial of
NRDCs Hearing Requests
EPA denies NRDCs request for a
hearing on whether reliable data
support EPAs reduction of the
childrens safety factor and on whether
EPA properly relied on the Gledhill
human study. EPAs close examination
of each of the 19 sub-issues involved in
these two hearing requests demonstrates
that none of the issues satisfies the
standard for granting a hearing in 40
CFR 178.32. Most fail for multiple
reasons.
Several sub-issues do not present an
issue of genuinely-disputed fact.
Instead, NRDC raises issues presenting
purely legal or policy questions or
questions involving the application of
legal standards to undisputed facts. For
example, with regard to its childrens
safety factor objection, NRDC makes the
legal argument that failure to complete
the mandatory endocrine screening
program compels EPA to retain the
childrens safety factor for DDVP and all
other pesticides. (See Unit VIII.D.2.a.).
In other cases, NRDCs description of a
factual dispute is clearly contradicted
by the record. An example here is
NRDCs assertion that EPA failed to
consider acute residential exposure
even though EPA, in response to
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NRDCs petition, amended its risk
assessment to include examination of
exposure for 1day and 14day periods.
(See Unit VIII.D.4.c.)
Many of NRDCs sub-issues lack
materiality. In some instances that is
due to NRDCs misunderstanding of a
scientific concept - as when NRDC
raises questions about the statistical
power of the Gledhill study or seeks to
invalidate the Gledhill study based on a
alleged inadequacy to control for
environmental factors. Both of these
concepts have little relevance given the
positive results found in that study. (See
Units VIII.E.3.a. and VIII.E.3.e.). In other
instances, the sub-issues presented by
NRDC lack materiality either because (1)
NRDC objects to aspects of EPAs risk
assessments that were changed in
response to the petition; (2) NRDC fails
to address the reasons given by EPA for
denying NRDCs petition; or (3) NRDC
objects to prior conclusions of EPA that
were superseded by the petition denial
order. (See Units VIII.D.3., VIII.E.3.b.,
and VIII.E.3.g.)
Most importantly, as to all of the sub-
issues, NRDC fails to identify and
proffer evidence which, if established,
would resolve one or more questions in
NRDCs favor. As EPAs analysis shows,
NRDC essentially proffered no evidence
in support of its hearing requests and
objections and instead relies upon legal
and policy arguments and unsupported
or speculative factual assertions.
NRDCs attempted evidentiary proffers
are either: (1) so broad as to be
meaningless (e.g., the complete EPA
docket for DDVP); (2) too general to
define a factual issue as to DDVP (e.g.,
newspaper and law review articles); (3)
supportive of scientifically irrelevant
claims (e.g., Sass and Lockwood
articles); or (4) mere allegations or
general denials (e.g., NRDCs claim that
dietary risk assessment poses a serious
risk of understating risks posed by
DDVP; NRDCs speculation about how
many DDVP pest strips a homeowner
may use). (See Units VIII.C., VIII.D.3.,
and VIII.D.4.e.).
NRDCs failure to offer evidence in
support of its contentions is a consistent
pattern in this proceeding. NRDC
offered no greater support for its
arguments in its petition, in its
comments on the IRED, or, for that
matter, in its written or oral comments
to the HSRB. In these circumstances,
EPA questions whether granting a
hearing would have been appropriate
even if NRDC had, at this last stage of
the administrative process, suddenly
produced factual evidence in support of
its claims. Presumably, Congress created
a multi-stage administrative process for
resolution of tolerance petitions to give
EPA the opportunity in the first stage of
the proceeding to resolve factual issues,
where possible, through a notice-and-
comment process, prior to requiring
EPA to hold a full evidentiary hearing
- which can involve a substantial
investment of resources by all parties
taking part. While EPA has not held any
pesticide tolerance hearings under the
FFDCA, its experience with pesticide
hearings under FIFRA in the 1970s
indicates the process can be quite
lengthy. (See were e.g., Environmental
Defense Fund v. EPA, 548 F.2d 998,
1002 (D.C. Cir. 1976) (4 months were
needed for testimony in an expedited
FIFRA suspension proceeding);
Environmental Defense Fund, Inc. v.
EPA, 510 F.2d 1292, 1297 (D.C. Cir.
1975) (13 months of testimony in a
FIFRA cancellation proceeding);
Environmental Defense Fund v.
Ruckelshaus, 489 F.2d 1247, 1251 n. 24
(D.C. Cir. 1973) (During seven months
of hearings [in the DDT cancellation
proceeding], 125 witnesses appeared to
testify and 365 exhibits were placed in
evidence. The transcript of the hearings
was over 9,000 pages long.); Ref. 44 at
246 (referring to FIFRA cancellation
proceedings in the 1970s as the 100
years pesticide wars). Given that in
the ensuing 30 years the pesticide risk
assessment process has become
exponentially more complex, FFDCA
pesticide hearings have the potential for
being even more resource intensive.
Accordingly, if a party were to withhold
evidence from the first stage of a
tolerance petition proceeding and only
produce it as part of a request for a
hearing on an objection, EPA might very
likely determine that such an untimely
submission of supporting evidence
constituted an amendment to the
Original petition requiring a return to
the first stage of the administrative
process (if, consideration of information
that was previously available is
appropriate at all).
Finally, EPA notes that it is denying
NRDCs hearing requests under 40 CFR
178.32 and does not here rely on the
even broader discretionary authority to
deny hearing requests in FFDCA section
408(g)(2)(B). As recounted previously,
40 CFR 178.32 predates the explicit
addition to the statute by the FQPA of
the grant of authority to EPA to deny
hearings. That language provides that
EPA shall hold a public evidentiary
hearing if and to the extent the
Administrator determines that such a
public hearing is necessary to receive
factual evidence relevant to material
issues of fact raised by the objections.
(21 U.S.C. 346a(g)(2)(B)). EPA does not
interpret this language as requiring it to
hold a hearing in any instance where
factual evidence relevant to a material
issue of fact is proffered (essentially the
standard set forth in 40 CFR 178.32);
rather, EPA construes the statutory
language as requiring it to hold a
hearing only where it determines a
hearing is necessary to receive such
proffered evidence. In other words, a
party wishing to obtain a hearing must
not only satisfy the requirements of 40
CFR 178.32, it must also show that an
evidentiary hearing is necessary to
presentation of proffered evidence to the
Agency. Because, however, NRDC has
not satisfied the standard set forth in 40
CFR 178.32, EPA does not need to
address whether a hearing is necessary
to receive NRDCs evidentiary proffer.
G. Summary of Reasons for Denial of
NRDCs Objections
EPA denies NRDCs objections to
EPAs petition denial that EPA lacked
sufficient data to reduce the childrens
safety factor for DDVP, and EPA
unlawfully relied on the Gledhill
intentional human dosing study in
assessing the risk of DDVP exposure.
1. Childrens safety factor objection.
In support of its childrens safety factor
objection, NRDC claims that EPA has
inadequate data on endocrine effects,
dietary exposure to DDVP residues in
food, and exposure from residential pest
strips. On endocrine effects, NRDC
argues that EPA lacks adequate data, as
a legal matter, because it has not
completed the section 408(p) endocrine
screening program, and, as a factual
matter, because DDVP has not been
tested under the most recent two-
generation rat reproduction study. EPA
has previously rejected NRDCs legal
argument as not consistent with the
statutory language, structure, or history,
and NRDC has offered no arguments as
to why EPAs previous conclusion was
incorrect. On the factual question of
whether EPA has adequate endocrine
data on DDVP, EPA concluded in the
petition denial that, given the existing
data bearing on DDVPs potential to
cause endocrine effects and large
difference in sensitivity between
DDVPs cholinesterase inhibition effects
and potential endocrine effects, EPA
had sufficient reliable data on DDVPs
potential endocrine effects to vary from
the default childrens safety factor. In its
objections, NRDC offers nothing other
than speculation about what another
two-generation rat reproduction study
might show. NRDCs speculation does
not convince EPA that its analysis was
incorrect.
As to dietary exposure to DDVP
residues in food, NRDC argues that
EPAs dietary exposure assessment has
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many shortcomings that may lead to
underestimation of dietary exposure to
DDVP. In support of this claim, NRDC
relies on statements EPA made in 2000
in a preliminary risk assessment of
DDVP. NRDC places particular
emphasis on its claim that EPAs
database on food consumption by
infants is inadequate. These allegations
by NRDC lack merit because NRDC has
ignored the many revisions to the DDVP
risk assessment since the 2000
preliminary risk assessment. First, EPA
completely revised the dietary exposure
and risk assessment in response to
NRDCs petition. One of the specific
reasons for revising the risk assessment
was so that EPAs latest information on
infant food consumption could be
incorporated. Second, also in response
to NRDCs petition, EPA
comprehensively analyzed its dietary
exposure assessment to evaluate
whether that assessment potentially
underestimated dietary exposure to
DDVP. EPA concluded that its
assessment of exposure to DDVP from
food will not under-estimate but rather
over-estimate, and in all likelihood
substantially over-estimate, DDVP
exposure. (72 FR at 68686). NRDC
neither acknowledges nor challenges the
revised dietary exposure assessment or
EPAs detailed analysis of whether that
assessment under- or over-estimates
DDVP exposure. Finally, EPA questions
the materiality of NRDCs argument
with regard to DDVP exposure from
food given that DDVP exposure from
this source is trivial compared with
other sources. For all of these reasons,
EPA rejects NRDCs arguments on the
alleged inadequacy of EPAs assessment
of human dietary exposure to DDVP in
food.
With regard to DDVP exposure from
residential pest strips, NRDC claims that
the data relied upon by EPA (the Collins
and DeVries study) was inadequate and
EPAs risk assessment based on that
study was based on inadequately-
supported assumptions. These
arguments, however, are without merit
because not only does NRDC offer
nothing other than general,
undocumented contentions in support
but once again NRDC has ignored clear
evidence and analysis in the record that
contradict its allegations. First, NRDC
ignores the other DDVP pest strip
exposure studies relied upon by EPA to
support the findings in the Collins and
DeVries study. EPA concluded that
these studies confirmed that the
findings in Collins and DeVries were
representative of DDVP concentration
levels from pest strips that could be
expected in houses in other locations.
Second, NRDC ignores EPAs complete
revision to the DDVP residential
exposure assessment that was
conducted in response to its petition.
That revision modified numerous
assumptions in the assessment to ensure
that the data from the Collins and
DeVries study were analyzed in a
conservative fashion. NRDC does not
acknowledge the new assessment much
less offer a rebuttal to EPAs revised
analysis. Most surprisingly, NRDC
repeats challenges to several
assumptions (only examining DDVP
exposure as averaged over a 120day
period; considering 16 hours per day a
maximum exposure in a home) that
were explicitly modified (adding
consideration of 1day and 14day
exposure periods; assuming 24 hours
exposure per day) in the revised risk
assessment in response to NRDCs
petition. Accordingly, EPA disagrees
with NRDCs allegations concerning the
inadequacy of the data and assumptions
underlying its residential pest strip risk
assessment.
2. Human study objection. NRDC
challenged EPAs reliance on the
Gledhill human study arguing that
EPAs Human Research rule is unlawful
and the study was both scientifically
flawed and unethically conducted.
NRDC relies on its legal briefs filed in
a separate challenge to the Human
Research rule and its comments on that
rule in support of its legal attack on the
rule. Similarly, to the extent NRDC has
standing to challenge a rule whose
primary concern is the [p]rotection
of the health and safety of human test
subjects, (Ref. 1 at 15), EPA relies on
its legal brief in the 2nd Circuit
proceeding and the administrative
record for the rule, in denying NRDCs
challenge to Human Research Rule.
As to the Gledhill study, itself, NRDC
makes various claims regarding its
scientific validity and ethicality. NRDC
has previously presented these claims in
writing and orally to EPAs HSRB. The
HSRB is an independent scientific
panel, consisting of experts in bioethics,
biostatistics, human health risk
assessment, and human toxicology,
created specifically for the purpose of
advising EPA on whether human
studies have scientific value and
conform to ethical standards. Although
NRDCs concerns as to the Gledhill
study were presented to the HSRB, the
HSRB concluded that the Gledhill study
complied with the Human Research rule
and could be considered by EPA in
assessing the risk of DDVP. EPA relied
heavily on the advice by the HSRB in
denying NRDCs petition. Remarkably,
NRDC, in its objections, proceeds as if
the HSRB review never occurred. NRDC
neither acknowledges the existence of
the HSRB report nor attempts to refute
its reasoning. In Unit VIII.E. above, EPA
repeats the findings of the HSRB and
EPAs reasons for accepting the HSRBs
conclusions with regard to the specific
contentions of NRDC. Based on both the
findings of the HSRB and EPA in its
petition denial, as described above, as
well as NRDCs failure to meaningfully
dispute those findings, EPA rejects
NRDCs challenge to EPAs reliance on
the Gledhill study.
H. Conclusion
For all of the reasons set forth above,
EPA denies NRDCs objections and its
requests for a hearing on those
objections.
IX. References
1. Natural Resources Defense Council,
Objection to the Order Denying
NRDCs Petition to Revoke All
Tolerances for Dichlorvos (DDVP), and
Request for Public Evidentiary Hearing
(February 1, 2008).
2. Natural Resources Defense Council,
Petition of Natural Resources Defense
Council To Conclude Special Review,
Reregistration and Tolerance
Reassessment Processes and To Revoke
All Tolerances and Cancel All
Registrations for the Pesticide DDVP
(June 2, 2006).
3. Office of Prevention, Pesticides and
Toxic Substances, EPA, Interim
Reregistration Eligibility Decision for
Dichlorvos (DDVP) (June 2006).
4. U.S. EPA, A Users Guide to
Available EPA Information on Assessing
Exposure to Pesticides in Food (June
21, 2000).
5. Office of Pesticide Programs, US
EPA, Office of Pesticide Programs
Policy on the Determination of the
Appropriate FQPA Safety Factor(s) For
Use in the Tolerance Setting Process
(February 28, 2002).
6. U.S. EPA, Residue Chemistry Test
Guidelines: OPPTS 860.1500 Crop Field
Trials (August 1996).
7. Office of Pesticide Programs, U.S.
EPA and Pest Regulatory Management
Agency, Health Canada, NAFTA
Guidance Document for Guidance for
Setting Pesticide Tolerances Based on
Field Trial Data (September 28, 2005).
8. Office of Pesticide Programs, U.S.
EPA, Choosing a Percentile of Acute
Dietary Exposure as a Threshold of
Regulatory Concern March 16, 2000).
9. Office of Pesticide Programs, U.S.
EPA,Standard Operating Procedures
(SOPs) for Residential Exposure
Assessments (Draft December 19,
1997).
10. Office of Pesticide Programs, U.S.
EPA, The Use of Data on
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Cholinesterase Inhibition for Risk
Assessments of Organophosphorous and
Carbamate Pesticides (August 18,
2000).
11. U.S. EPA, Endocrine Disruptor
Screening and Testing Advisory
Committee Final Report (August 1998).
12. U.S. EPA, U.S. EPA Charter:
Human Studies Review Board (2008)
(available at http://www.epa.gov/osa/
hsrb/files/dated-hsrb-renewal-charter-
effect-030408.pdf).
13. Office of Pesticide Programs, U.S.
EPA, Organophosphorus Cumulative
Risk Assessment 2006 Update
(August 2006).
14. Office of Prevention, Pesticides
and Toxic Substances, EPA,
Memorandum from Debra Edwards to
Jim Jones, Finalization of Interim
Reregistration Eligibility Decisions
(IREDs) and Interim Tolerance
Reassessment and Risk Management
Decisions (TREDs) for the
Organophosphate Pesticides, and
Completion of the Tolerance
Reassessment and Reregistration
Eligibility Process for the
Organophosphate Pesticides (July 31,
2006).
15. Office of Pesticide Programs, U.S.
EPA, Data Evaluation Report:
Dichlorvos: A Single Blind, Placebo
Controlled, Randomized Study to
Investigate the Effects of Multiple Oral
Dosing on Erythrocyte Cholinesterase
Inhibition in Healthy Male Volunteers
(March 24, 1998).
16. Office of Prevention, Pesticides
and Toxic Substances, EPA,
Memorandum from Ray Kent/William
Dykstra to Tina Levine, Human Studies
Review Board: Final Weight of Evidence
Comparison of Human and Animal
Toxicology Studies and Endpoints for
DDVP Human Health Risk Assessment
and Discussion of Interspecies
Extrapolation in the Organophosphate
Cumulative Risk Assessment (March
20, 2006).
17. Sass, J., Natural Resources Defense
Council, NRDC comments for the
HSRB meeting April 4-6, 2006
(undated).
18. EPA Human Studies Review
Board, Minutes of the United States
Environmental Protection Agency (EPA)
Human Studies Review Board (HSRB)
April 4-6, 2006 Public Meeting Docket
Number: EPAHQORD20060187
(May 15, 2006).
19. EPA Human Studies Review
Board, Letter from Celia Fisher to
George Gray, April 4-6, 2006 Meeting
EPA Human Studies Review Board
Report Proposed Final Draft V. 1
(May 16, 2006).
20. EPA Human Studies Review
Board, Minutes of the United States
Environmental Protection Agency (EPA)
Human Studies Review Board (HSRB)
June 8, 2006 Public Teleconference
Docket Number: EPAHQORD2006
0187 (June 19, 2006).
21. EPA Human Studies Review
Board, Letter from Celia Fisher to
George Gray, April 4-6, 2006 Meeting
EPA Human Studies Review Board
Report (June 26, 2006).
22. Amvac Chemical Corporation,
Comments of Amvac Chemical
Corporation in Reponse to EPAs Notice
of a Petition to Revoke Tolerances
Established for Dichlorvos (November
13, 2006).
23. Natural Resources Defense
Council, Letter submitting comments
Re: Dichlorvos Interim Reregistration
Eligibility Decision, 71 FR 37568 (June
30, 2006) (August 28, 2006).
24. Reference Dose/Reference
Concentration (RfD/RfC) Technical
Panel, Risk Assessment Forum, U.S.
EPA, A Review of the Reference Dose
and Reference Concentration Processes
(December 2002).
25. USDA, Food and Nutrient
Intakes by Children 1994-96, 1998,
Table Set 17 (December 1999).
26. USDA, Documentation:
Supplemental Childrens Survey (CSFII
1998) to the 1994-96 Continuing Survey
of Food Intakes by Individuals (2000).
27. Office of Prevention, Pesticides
and Toxic Substances, EPA,
Memorandum from Susan V. Hummel
to Kimberly Lowe/Robert McNally,
Revised Preliminary HED Risk
Assessment for Dichlorvos (August 9,
2000).
28. U.S. EPA, Letter from George T.
LaRocca, Product Manager (13),
Insecticide Branch, Registration
Division, to Jon C. Wood, Amvac
Chemical Corp., Dichlorvos (DDVP)
Label Amendments (October 11, 2006).
29. Petitioners Brief, NRDC v. EPA,
(2nd Cir. 06-0820-ag) (October 4, 2006).
30. Natural Resources Defense
Council, Protections for Subjects in
Human Research; Proposed Rule, 70 FR
53838 (Sept. 12, 2005) (December 12,
2005).
31. Respondents Brief, NRDC v. EPA,
(2nd Cir. 06-0820-ag) (November 16,
2006).
32. Federal Judicial Center,
Reference Manual on Scientific
Evidence (2d ed. 2000).
33. Sass, J.B., Needleman, H.L.,
Industry Testing of Toxic Pesticides on
Human Subjects Concluded No Effect,
Despite the Evidence, Environmental
Health Perspectives. 2004 Mar; 112(3)
A150-151.
34. Sass, J.B., Needleman, H.L.,
Human Testing: Sass and Needleman
Respond to Industry, Environmental
Health Perspectives. 2004 Ma; 112(6)
A340-341.
35. Lockwood, A.H., Human Testing
of Pesticides: Ethical and Scientific
Considerations, American Journal of
Public Health 2004 Nov; 94(11) 1908-
1916.
36. Lockwood, A.H., The Ethical Bar
Drops to Unacceptable, Environmental
Forum. 2005 Nov/Dec; 48.
37. U.S. EPA, Tolerance Reassessment
(March 6, 2008) (published at http://
www.epa.gov/pesticides/tolerance/
reassessment.htm).
38. Baetcke, K.P., Phang, W., and
Dellarco, V., Health Effects Division,
Office of Pesticide Programs, U.S. EPA,
A Comparison of the Results of Studies
on Pesticides from 12- or 24-Month Dog
Studies with Dog Studies of Shorter
Duration (April 7, 2005).
39. U.S. Food and Drug
Administration, Toxicological
Principles for the Safety Assessment of
Food Ingredients: Redbook 2000, secs.
IV.C.4b and IV.C.5. (November 2003).
40. OECD, OECD Guideline For The
Testing Of Chemicals: Repeated Dose
90day Oral Toxicity Study in Non-
Rodents 409 (September 1998).
41. OECD, OECD Guideline For The
Testing Of Chemicals: Chronic Toxicity
Studies 452 (May 1981).
42. OECD Test Guideline No. 452,
Chronic Toxicity Studies dated May
12, 1981; (CPR 52(a)(iii), 52(b)(ii),
52(c)(ii), 59(a)(iii), 59(b)(ii), 59(c)(ii) and
63) (Can).
43. Council Directive No. 2001/59/EC,
O.J. L 225 (2001) (Annex V of Dir 67/
548/EEC on the Classification,
Packaging and Labeling of Dangerous
Substances (http://ecb.jrc.it/testing-
methods/annex5)).
44. William Rodgers, Environmental
Law: Pesticides and Toxic Substances
(1988).
X. Regulatory Assessment
Requirements
As indicated previously, this action
announces the Agencys final order
regarding objections filed under section
408 of FFDCA. As such, this action is an
adjudication and not a rule. The
regulatory assessment requirements
imposed on rulemaking do not,
therefore, apply to this action.
XI. Submission to Congress and the
Comptroller General
The Congressional Review Act, (5
U.S.C. 801 et seq.), as added by the
Small Business Regulatory Enforcement
Fairness Act of 1996, does not apply
because this action is not a rule for
purposes of 5 U.S.C. 804(3).
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Appendix 1United States
Environmental Protection Agency
Human Studies Review Board
Chair
Celia B. Fisher, Ph.D. Marie Ward Doty
Professor of Psychology, Director, Center
for Ethics Education, Fordham University,
Department of Psychology, Bronx, NY
Vice Chair
William S. Brimijoin, Ph.D., Chair and
Professor, Molecular Pharmacology and
Experimental Therapeutics, Mayo
Foundation, Rochester, MN
Members
David C. Bellinger, Ph.D., Professor of
Neurology, Harvard Medical School
Professor in the Department of
Environmental Health, Harvard School of
Public Health Childrens Hospital, Boston,
MA
Alicia Carriquiry, Ph.D., Professor,
Department of Statistics, Iowa State
University Snedecor Hall, Ames, IA
Gary L. Chadwick, PharmD, MPH, CIP,
Associate Provost, Director, Office for
Human Subjects Protection, University of
Rochester, Rochester, NY
Janice Chambers, Ph.D., D.A.B.T., William L.
Giles Distinguished Professor, Director,
Center for Environmental Health Sciences,
College of Veterinary Medicine,
Mississippi State University, Wise Center,
Mississippi State, MS
Richard Fenske, Ph.D., MPH, Professor,
Department of Environmental and
Occupational Health Sciences, University
of Washington, Seattle, WA
Susan S. Fish, PharmD, MPH, Professor,
Biostatistics and Epidemiology, Boston
University School of Public Health, Co-
Director, MA in Clinical Investigation
Boston University School of Medicine,
Boston, MA
Suzanne C. Fitzpatrick, Ph.D., DABT, Senior
Science Policy Analyst, Office of the
Commissioner, Office of Science and
Health Coordination, U.S. Food and Drug
Administration, Rockville, MD
Kannan Krishnan, Ph.D., Professor,
Departement de sante environnementale et
sante au travail, Faculte de medicine,
Universite de Montreal, Montreal, Canada
KyungMann Kim, Ph.D., CCRP, Professor and
Associate Chair, Department of
Biostatistics and Medical Informatics,
School of Medicine and Public Health,
University of Wisconsin-Madison,
Madison, WI
Michael D. Lebowitz, Ph.D., FCCP, Professor
of Public Health and Medicine. University
of Arizona, Tucson, AZ
Lois D. Lehman-Mckeeman, Ph.D.,
Distinguished Research Fellow, Discovery
Toxicology, Bristol-Myers Squibb
Company, Princeton, NJ
Jerry A. Menikoff, M.D., Associate Professor
of Law, Ethics and Medicine, Director of
the Institute for Bioethics, Law and Public
Policy, University of Kansas Medical
Center, Kansas City, KS
Robert Nelson, M.D., Ph.D., Associate
Professor of Anesthesiology and Critical
Care, Department of Anesthesiology and
Critical Care, University of Pennsylvania
School of Medicine, The Childrens
Hospital of Philadelphia, Philadelphia, PA
Sean M. Philpott, Ph.D., Research Scientist,
David Axelrod Institute, Wadsworth Center
for Laboratories and Research, New York
State Department of Health, Albany, NY
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 11, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E816617 Filed 72208; 8:45 am]
BILLING CODE 656050S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPAHQOPP20080302; FRL83695]
Fludioxonil; Pesticide Tolerance for
Emergency Exemption
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a
time-limited tolerance for residues of
fludioxonil in or on carambola
(starfruit). This action is in response to
EPAs granting of an emergency
exemption under section 18 of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing
use of the pesticide on carambola. This
regulation establishes a maximum
permissible level for residues of
fludioxonil in starfruit. The time-limited
tolerance expires and is revoked on
December 31, 2010.
DATES: This regulation is effective July
23, 2008. Objections and requests for
hearings must be received on or before
September 22, 2008, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPAHQ
OPP20080302. To access the
electronic docket, go to http://
www.regulations.gov, select Advanced
Search, then Docket Search. Insert
the docket ID number where indicated
and select the Submit button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either in the electronic docket
at http://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 3055805.
FOR FURTHER INFORMATION CONTACT:
Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 204600001; telephone number:
(703) 3089356; e-mail address:
conrath.andrea@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code
112).
Food manufacturing (NAICS code
311).
Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
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UnILed SLuLes Code AnnoLuLed
TILIe ;. AgrIcuILure
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SubchuLer . EnvIronmenLuI PesLIcIde ConLroI (ReIs & Annos)
; U.S.C.A. 16
16. DeIInILIons
EIIecLIve: AugusL , 1qq6
CurrenLness
For purposes of this subchapter--
(a) Active ingredient
The term active ingredient means--
(1) in the case of a pesticide other than a plant regulator, defoliant, desiccant, or nitrogen stabilizer, an ingredient which will
prevent, destroy, repel, or mitigate any pest;
(2) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of
growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof;
(3) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant;
(4) in the case of a desiccant, an ingredient which will artificially accelerate the drying of plant tissue; and
(5) in the case of a nitrogen stabilizer, an ingredient which will prevent or hinder the process of nitrification, denitrification,
ammonia volatilization, or urease production through action affecting soil bacteria.
(b) Administrator
The term Administrator means the Administrator of the Environmental Protection Agency.
(c) Adulterated
The term adulterated applies to any pesticide if--
(1) its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold;
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(2) any substance has been substituted wholly or in part for the pesticide; or
(3) any valuable constituent of the pesticide has been wholly or in part abstracted.
(d) Animal
The term animal means all vertebrate and invertebrate species, including but not limited to man and other mammals, birds,
fish, and shellfish.
(e) Certified applicator, etc.
(1) Certified applicator
The term certified applicator means any individual who is certified under section 136i of this title as authorized to use
or supervise the use of any pesticide which is classified for restricted use. Any applicator who holds or applies registered
pesticides, or uses dilutions of registered pesticides consistent with subsection (ee) of this section, only to provide a service of
controlling pests without delivering any unapplied pesticide to any person so served is not deemed to be a seller or distributor
of pesticides under this subchapter.
(2) Private applicator
The term private applicator means a certified applicator who uses or supervises the use of any pesticide which is classified
for restricted use for purposes of producing any agricultural commodity on property owned or rented by the applicator or
the applicator's employer or (if applied without compensation other than trading of personal services between producers of
agricultural commodities) on the property of another person.
(3) Commercial applicator
The term commercial applicator means an applicator (whether or not the applicator is a private applicator with respect to
some uses) who uses or supervises the use of any pesticide which is classified for restricted use for any purpose or on any
property other than as provided by paragraph (2).
(4) Under the direct supervision of a certified applicator
Unless otherwise prescribed by its labeling, a pesticide shall be considered to be applied under the direct supervision of a
certified applicator if it is applied by a competent person acting under the instructions and control of a certified applicator
who is available if and when needed, even though such certified applicator is not physically present at the time and place
the pesticide is applied.
(f) Defoliant
The term defoliant means any substance or mixture of substances intended for causing the leaves or foliage to drop from a
plant, with or without causing abscission.
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(g) Desiccant
The term desiccant means any substance or mixture of substances intended for artificially accelerating the drying of plant
tissue.
(h) Device
The term device means any instrument or contrivance (other than a firearm) which is intended for trapping, destroying,
repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other
microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides
when sold separately therefrom.
(i) District court
The term district court means a United States district court, the District Court of Guam, the District Court of the Virgin
Islands, and the highest court of American Samoa.
(j) Environment
The term environment includes water, air, land, and all plants and man and other animals living therein, and the
interrelationships which exist among these.
(k) Fungus
The term fungus means any non-chlorophyll-bearing thallophyte (that is, any non-chlorophyll-bearing plant of a lower order
than mosses and liverworts), as for example, rust, smut, mildew, mold, yeast, and bacteria, except those on or in living man or
other animals and those on or in processed food, beverages, or pharmaceuticals.
(l) Imminent hazard
The term imminent hazard means a situation which exists when the continued use of a pesticide during the time required
for cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve
unreasonable hazard to the survival of a species declared endangered or threatened by the Secretary pursuant to the Endangered
Species Act of 1973 [16 U.S.C.A. 1531 et seq.].
(m) Inert ingredient
The term inert ingredient means an ingredient which is not active.
(n) Ingredient statement
The term ingredient statement means a statement which contains--
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(1) the name and percentage of each active ingredient, and the total percentage of all inert ingredients, in the pesticide; and
(2) if the pesticide contains arsenic in any form, a statement of the percentages of total and water soluble arsenic, calculated
as elementary arsenic.
(o) Insect
The term insect means any of the numerous small invertebrate animals generally having the body more or less obviously
segmented, for the most part belonging to the class insecta, comprising six-legged, usually winged forms, as for example,
beetles, bugs, bees, flies, and to other allied classes of arthropods whose members are wingless and usually have more than six
legs, as for example, spiders, mites, ticks, centipedes, and wood lice.
(p) Label and labeling
(1) Label
The term label means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers
or wrappers.
(2) Labeling
The term labeling means all labels and all other written, printed, or graphic matter--
(A) accompanying the pesticide or device at any time; or
(B) to which reference is made on the label or in literature accompanying the pesticide or device, except to current official
publications of the Environmental Protection Agency, the United States Departments of Agriculture and Interior, the
Department of Health and Human Services, State experiment stations, State agricultural colleges, and other similar Federal
or State institutions or agencies authorized by law to conduct research in the field of pesticides.
(q) Misbranded
(1) A pesticide is misbranded if--
(A) its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false
or misleading in any particular;
(B) it is contained in a package or other container or wrapping which does not conform to the standards established by the
Administrator pursuant to section 136w(c)(3) of this title;
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(C) it is an imitation of, or is offered for sale under the name of, another pesticide;
(D) its label does not bear the registration number assigned under section 136e of this title to each establishment in which
it was produced;
(E) any word, statement, or other information required by or under authority of this subchapter to appear on the label or
labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs,
or graphic matter in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
(F) the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for
which the product is intended and if complied with, together with any requirements imposed under section 136a(d) of this
title, are adequate to protect health and the environment;
(G) the label does not contain a warning or caution statement which may be necessary and if complied with, together with
any requirements imposed under section 136a(d) of this title, is adequate to protect health and the environment; or
(H) in the case of a pesticide not registered in accordance with section 136a of this title and intended for export, the
label does not contain, in words prominently placed thereon with such conspicuousness (as compared with other words,
statements, designs, or graphic matter in the labeling) as to render it likely to be noted by the ordinary individual under
customary conditions of purchase and use, the following: Not Registered for Use in the United States of America.
(2) A pesticide is misbranded if--
(A) the label does not bear an ingredient statement on that part of the immediate container (and on the outside container or
wrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannot
be clearly read) which is presented or displayed under customary conditions of purchase, except that a pesticide is not
misbranded under this subparagraph if--
(i) the size or form of the immediate container, or the outside container or wrapper of the retail package, makes it
impracticable to place the ingredient statement on the part which is presented or displayed under customary conditions
of purchase; and
(ii) the ingredient statement appears prominently on another part of the immediate container, or outside container or
wrapper, permitted by the Administrator;
(B) the labeling does not contain a statement of the use classification under which the product is registered;
(C) there is not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, through
which the required information on the immediate container cannot be clearly read, a label bearing--
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(i) the name and address of the producer, registrant, or person for whom produced;
(ii) the name, brand, or trademark under which the pesticide is sold;
(iii) the net weight or measure of the content, except that the Administrator may permit reasonable variations; and
(iv) when required by regulation of the Administrator to effectuate the purposes of this subchapter, the registration
number assigned to the pesticide under this subchapter, and the use classification; and
(D) the pesticide contains any substance or substances in quantities highly toxic to man, unless the label shall bear, in
addition to any other matter required by this subchapter--
(i) the skull and crossbones;
(ii) the word poison prominently in red on a background of distinctly contrasting color; and
(iii) a statement of a practical treatment (first aid or otherwise) in case of poisoning by the pesticide.
(r) Nematode
The term nematode means invertebrate animals of the phylum nemathelminthes and class nematoda, that is, unsegmented
round worms with elongated, fusiform, or saclike bodies covered with cuticle, and inhabiting soil, water, plants, or plant parts;
may also be called nemas or eelworms.
(s) Person
The term person means any individual, partnership, association, corporation, or any organized group of persons whether
incorporated or not.
(t) Pest
The term pest means (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or
animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man
or other living animals) which the Administrator declares to be a pest under section 136w(c)(1) of this title.
(u) Pesticide
The term pesticide means (1) any substance or mixture of substances intended for preventing, destroying, repelling, or
mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant,
and (3) any nitrogen stabilizer, except that the term pesticide shall not include any article that is a new animal drug within
the meaning of section 321(w) of Title 21, that has been determined by the Secretary of Health and Human Services not to be
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a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaning
of section 321(x) of Title 21 bearing or containing a new animal drug. The term pesticide does not include liquid chemical
sterilant products (including any sterilant or subordinate disinfectant claims on such products) for use on a critical or semi-
critical device, as defined in section 321 of Title 21. For purposes of the preceding sentence, the term critical device includes
any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile
areas of the body and the term semi-critical device includes any device which contacts intact mucous membranes but which
does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.
(v) Plant regulator
The term plant regulator means any substance or mixture of substances intended, through physiological action, for accelerating
or retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of plants or the produce thereof, but
shall not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plant
inoculants, and soil amendments. Also, the term plant regulator shall not be required to include any of such of those nutrient
mixtures or soil amendments as are commonly known as vitamin-hormone horticultural products, intended for improvement,
maintenance, survival, health, and propagation of plants, and as are not for pest destruction and are nontoxic, nonpoisonous
in the undiluted packaged concentration.
(w) Producer and produce
The term producer means the person who manufactures, prepares, compounds, propagates, or processes any pesticide or
device or active ingredient used in producing a pesticide. The term produce means to manufacture, prepare, compound,
propagate, or process any pesticide or device or active ingredient used in producing a pesticide. The dilution by individuals
of formulated pesticides for their own use and according to the directions on registered labels shall not of itself result in such
individuals being included in the definition of producer for the purposes of this subchapter.
(x) Protect health and the environment
The terms protect health and the environment and protection of health and the environment mean protection against any
unreasonable adverse effects on the environment.
(y) Registrant
The term registrant means a person who has registered any pesticide pursuant to the provisions of this subchapter.
(z) Registration
The term registration includes reregistration.
(aa) State
The term State means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the
Trust Territory of the Pacific Islands, and American Samoa.
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(bb) Unreasonable adverse effects on the environment
The term unreasonable adverse effects on the environment means (1) any unreasonable risk to man or the environment, taking
into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk
from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of Title
21. The Administrator shall consider the risks and benefits of public health pesticides separate from the risks and benefits of
other pesticides. In weighing any regulatory action concerning a public health pesticide under this subchapter, the Administrator
shall weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlled
by the pesticide.
(cc) Weed
The term weed means any plant which grows where not wanted.
(dd) Establishment
The term establishment means any place where a pesticide or device or active ingredient used in producing a pesticide is
produced, or held, for distribution or sale.
(ee) To use any registered pesticide in a manner inconsistent with its labeling
The term to use any registered pesticide in a manner inconsistent with its labeling means to use any registered pesticide in a
manner not permitted by the labeling, except that the term shall not include (1) applying a pesticide at any dosage, concentration,
or frequency less than that specified on the labeling unless the labeling specifically prohibits deviation from the specified dosage,
concentration, or frequency, (2) applying a pesticide against any target pest not specified on the labeling if the application is
to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state
that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use
of the pesticide against other pests would cause an unreasonable adverse effect on the environment, (3) employing any method
of application not prohibited by the labeling unless the labeling specifically states that the product may be applied only by the
methods specified on the labeling, (4) mixing a pesticide or pesticides with a fertilizer when such mixture is not prohibited
by the labeling, (5) any use of a pesticide in conformance with section 136c, 136p, or 136v of this title, or (6) any use of a
pesticide in a manner that the Administrator determines to be consistent with the purposes of this subchapter. After March 31,
1979, the term shall not include the use of a pesticide for agricultural or forestry purposes at a dilution less than label dosage
unless before or after that date the Administrator issues a regulation or advisory opinion consistent with the study provided
for in section 27(b) of the Federal Pesticide Act of 1978, which regulation or advisory opinion specifically requires the use
of definite amounts of dilution.
(ff) Outstanding data requirement
(1) In general
The term outstanding data requirement means a requirement for any study, information, or data that is necessary to make
a determination under section 136a(c)(5) of this title and which study, information, or data--
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(A) has not been submitted to the Administrator; or
(B) if submitted to the Administrator, the Administrator has determined must be resubmitted because it is not valid,
complete, or adequate to make a determination under section 136a(c)(5) of this title and the regulations and guidelines
issued under such section.
(2) Factors
In making a determination under paragraph (1)(B) respecting a study, the Administrator shall examine, at a minimum, relevant
protocols, documentation of the conduct and analysis of the study, and the results of the study to determine whether the study
and the results of the study fulfill the data requirement for which the study was submitted to the Administrator.
(gg) To distribute or sell
The term to distribute or sell means to distribute, sell, offer for sale, hold for distribution, hold for sale, hold for shipment,
ship, deliver for shipment, release for shipment, or receive and (having so received) deliver or offer to deliver. The term does
not include the holding or application of registered pesticides or use dilutions thereof by any applicator who provides a service
of controlling pests without delivering any unapplied pesticide to any person so served.
(hh) Nitrogen stabilizer
The term nitrogen stabilizer means any substance or mixture of substances intended for preventing or hindering the process
of nitrification, denitrification, ammonia volatilization, or urease production through action upon soil bacteria. Such term shall
not include--
(1) dicyandiamide;
(2) ammonium thiosulfate; or
(3) any substance or mixture of substances.
1
--
(A) that was not registered pursuant to section 136a of this title prior to January 1, 1992; and
(B) that was in commercial agronomic use prior to January 1, 1992, with respect to which after January 1, 1992, the
distributor or seller of the substance or mixture has made no specific claim of prevention or hindering of the process of
nitrification, denitrification, ammonia volatilization
2
urease production regardless of the actual use or purpose for, or
future use or purpose for, the substance or mixture.
Statements made in materials required to be submitted to any State legislative or regulatory authority, or required by such
authority to be included in the labeling or other literature accompanying any such substance or mixture shall not be deemed a
specific claim within the meaning of this subsection.
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(jj)
3
Maintenance applicator
The term maintenance applicator means any individual who, in the principal course of such individual's employment, uses, or
supervises the use of, a pesticide not classified for restricted use (other than a ready to use consumer products pesticide); for the
purpose of providing structural pest control or lawn pest control including janitors, general maintenance personnel, sanitation
personnel, and grounds maintenance personnel. The term maintenance applicator does not include private applicators as
defined in subsection (e)(2) of this section; individuals who use antimicrobial pesticides, sanitizers or disinfectants; individuals
employed by Federal, State, and local governments or any political subdivisions thereof, or individuals who use pesticides not
classified for restricted use in or around their homes, boats, sod farms, nurseries, greenhouses, or other noncommercial property.
(kk) Service technician
The term service technician means any individual who uses or supervises the use of pesticides (other than a ready to use
consumer products pesticide) for the purpose of providing structural pest control or lawn pest control on the property of another
for a fee. The term service technician does not include individuals who use antimicrobial pesticides, sanitizers or disinfectants;
or who otherwise apply ready to use consumer products pesticides.
(ll) Minor use
The term minor use means the use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection
of public health where--
(1) the total United States acreage for the crop is less than 300,000 acres, as determined by the Secretary of Agriculture; or
(2) the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided by
an applicant for registration or a registrant, the use does not provide sufficient economic incentive to support the initial
registration or continuing registration of a pesticide for such use and--
(A) there are insufficient efficacious alternative registered pesticides available for the use;
(B) the alternatives to the pesticide use pose greater risks to the environment or human health;
(C) the minor use pesticide plays or will play a significant part in managing pest resistance; or
(D) the minor use pesticide plays or will play a significant part in an integrated pest management program.
The status as a minor use under this subsection shall continue as long as the Administrator has not determined that, based on
existing data, such use may cause an unreasonable adverse effect on the environment and the use otherwise qualifies for such
status.
(mm) Antimicrobial pesticide
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(1) In general
The term antimicrobial pesticide means a pesticide that--
(A) is intended to--
(i) disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and
(B) in the intended use is exempt from, or otherwise not subject to, a tolerance under section 346a of Title 21 or a food
additive regulation under section 348 of Title 21.
(2) Excluded products
The term antimicrobial pesticide does not include--
(A) a wood preservative or antifouling paint product for which a claim of pesticidal activity other than or in addition to
an activity described in paragraph (1) is made;
(B) an agricultural fungicide product; or
(C) an aquatic herbicide product.
(3) Included products
The term antimicrobial pesticide does include any other chemical sterilant product (other than liquid chemical sterilant
products exempt under subsection (u) of this section), any other disinfectant product, any other industrial microbiocide
product, and any other preservative product that is not excluded by paragraph (2).
(nn) Public health pesticide
The term public health pesticide means any minor use pesticide product registered for use and used predominantly in public
health programs for vector control or for other recognized health protection uses, including the prevention or mitigation of
viruses, bacteria, or other microorganisms (other than viruses, bacteria, or other microorganisms on or in living man or other
living animal) that pose a threat to public health.
(oo) Vector
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The term vector means any organism capable of transmitting the causative agent of human disease or capable of producing
human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or other insects and ticks, mites, or rats.
Credits
(June 25, 1947, c. 125, 2, as added Oct. 21, 1972, Pub.L. 92-516, 2, 86 Stat. 975; amended Dec. 28, 1973, Pub.L. 93-205,
13(f), 87 Stat. 903; Nov. 28, 1975, Pub.L. 94-140, 9, 89 Stat. 754; Sept. 30, 1978, Pub.L. 95-396, 1, 92 Stat. 819; Oct. 25,
1988, Pub.L. 100-532, Title I, 101, Title VI, 601(a), Title VIII, 801(a), 102 Stat. 2655, 2677, 2679; Dec. 13, 1991, Pub.L.
102-237, Title X, 1006(a)(1), (2), (b)(3)(A), (B), 105 Stat. 1894, 1895; Aug. 3, 1996, Pub.L. 104-170, Title I, 105(a), 120,
Title II, 210(a), 221, 230, Title III, 304, 110 Stat. 1490, 1492, 1493, 1502, 1508, 1512.)
Notes of Decisions (9)
Footnotes
1 So in original. Probably should not have a period.
2 So in original. Probably should be followed by , or.
3 So in original. No subsec. (ii) has been enacted.
7 U.S.C.A. 136, 7 USCA 136
Current through P.L. 112-197 approved 11-27-12
End of Document 2012 Thomson Reuters. No claim to original U.S. Government Works.
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; U.S.C.A. 16u
16u. RegIsLruLIon oI esLIcIdes
CurrenLness
(a) Requirement of registration
Except as provided by this subchapter, no person in any State may distribute or sell to any person any pesticide that is not
registered under this subchapter. To the extent necessary to prevent unreasonable adverse effects on the environment, the
Administrator may by regulation limit the distribution, sale, or use in any State of any pesticide that is not registered under this
subchapter and that is not the subject of an experimental use permit under section 136c of this title or an emergency exemption
under section 136p of this title.
(b) Exemptions
A pesticide which is not registered with the Administrator may be transferred if--
(1) the transfer is from one registered establishment to another registered establishment operated by the same producer
solely for packaging at the second establishment or for use as a constituent part of another pesticide produced at the second
establishment; or
(2) the transfer is pursuant to and in accordance with the requirements of an experimental use permit.
(c) Procedure for registration
(1) Statement required
Each applicant for registration of a pesticide shall file with the Administrator a statement which includes--
(A) the name and address of the applicant and of any other person whose name will appear on the labeling;
(B) the name of the pesticide;
(C) a complete copy of the labeling of the pesticide, a statement of all claims to be made for it, and any directions for its use;
(D) the complete formula of the pesticide;
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(E) a request that the pesticide be classified for general use or for restricted use, or for both; and
(F) except as otherwise provided in paragraph (2)(D), if requested by the Administrator, a full description of the tests made
and the results thereof upon which the claims are based, or alternatively a citation to data that appear in the public literature
or that previously had been submitted to the Administrator and that the Administrator may consider in accordance with
the following provisions:
(i) With respect to pesticides containing active ingredients that are initially registered under this subchapter after
September 30, 1978, data submitted to support the application for the original registration of the pesticide, or an
application for an amendment adding any new use to the registration and that pertains solely to such new use, shall
not, without the written permission of the original data submitter, be considered by the Administrator to support an
application by another person during a period of ten years following the date the Administrator first registers the
pesticide, except that such permission shall not be required in the case of defensive data.
(ii) The period of exclusive data use provided under clause (i) shall be extended 1 additional year for each 3 minor uses
registered after August 3, 1996, and within 7 years of the commencement of the exclusive use period, up to a total of 3
additional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretary
of Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that--
(I) there are insufficient efficacious alternative registered pesticides available for the use;
(II) the alternatives to the minor use pesticide pose greater risks to the environment or human health;
(III) the minor use pesticide plays or will play a significant part in managing pest resistance; or
(IV) the minor use pesticide plays or will play a significant part in an integrated pest management program.
The registration of a pesticide for a minor use on a crop grouping established by the Administrator shall be
considered for purposes of this clause 1 minor use for each representative crop for which data are provided in
the crop grouping. Any additional exclusive use period under this clause shall be modified as appropriate or
terminated if the registrant voluntarily cancels the product or deletes from the registration the minor uses which
formed the basis for the extension of the additional exclusive use period or if the Administrator determines that
the registrant is not actually marketing the product for such minor uses.
(iii) Except as otherwise provided in clause (i), with respect to data submitted after December 31, 1969, by an applicant
or registrant to support an application for registration, experimental use permit, or amendment adding a new use to an
existing registration, to support or maintain in effect an existing registration, or for reregistration, the Administrator may,
without the permission of the original data submitter, consider any such item of data in support of an application by any
other person (hereinafter in this subparagraph referred to as the applicant) within the fifteen-year period following the
date the data were originally submitted only if the applicant has made an offer to compensate the original data submitter
and submitted such offer to the Administrator accompanied by evidence of delivery to the original data submitter of
the offer. The terms and amount of compensation may be fixed by agreement between the original data submitter and
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the applicant, or, failing such agreement, binding arbitration under this subparagraph. If, at the end of ninety days
after the date of delivery to the original data submitter of the offer to compensate, the original data submitter and the
applicant have neither agreed on the amount and terms of compensation nor on a procedure for reaching an agreement
on the amount and terms of compensation, either person may initiate binding arbitration proceedings by requesting
the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by
such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such
arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official
or court of the United States shall have power or jurisdiction to review any such findings and determination, except for
fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a
verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other
misconduct. The parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator.
If the Administrator determines that an original data submitter has failed to participate in a procedure for reaching an
agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an
agreement or arbitration decision concerning compensation under this subparagraph, the original data submitter shall
forfeit the right to compensation for the use of the data in support of the application. Notwithstanding any other provision
of this subchapter, if the Administrator determines that an applicant has failed to participate in a procedure for reaching
an agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an
agreement or arbitration decision concerning compensation under this subparagraph, the Administrator shall deny the
application or cancel the registration of the pesticide in support of which the data were used without further hearing.
Before the Administrator takes action under either of the preceding two sentences, the Administrator shall furnish to
the affected person, by certified mail, notice of intent to take action and allow fifteen days from the date of delivery
of the notice for the affected person to respond. If a registration is denied or canceled under this subparagraph, the
Administrator may make such order as the Administrator deems appropriate concerning the continued sale and use of
existing stocks of such pesticide. Registration action by the Administrator shall not be delayed pending the fixing of
compensation.
(iv) After expiration of any period of exclusive use and any period for which compensation is required for the use of an
item of data under clauses (i), (ii), and (iii), the Administrator may consider such item of data in support of an application
by any other applicant without the permission of the original data submitter and without an offer having been received
to compensate the original data submitter for the use of such item of data.
(v) The period of exclusive use provided under clause (ii) shall not take effect until 1 year after August 3, 1996,
except where an applicant or registrant is applying for the registration of a pesticide containing an active ingredient
not previously registered.
(vi) With respect to data submitted after August 3, 1996, by an applicant or registrant to support an amendment adding a
new use to an existing registration that does not retain any period of exclusive use, if such data relates solely to a minor
use of a pesticide, such data shall not, without the written permission of the original data submitter, be considered by
the Administrator to support an application for a minor use by another person during the period of 10 years following
the date of submission of such data. The applicant or registrant at the time the new minor use is requested shall notify
the Administrator that to the best of their knowledge the exclusive use period for the pesticide has expired and that the
data pertaining solely to the minor use of a pesticide is eligible for the provisions of this paragraph. If the minor use
registration which is supported by data submitted pursuant to this subsection is voluntarily canceled or if such data are
subsequently used to support a nonminor use, the data shall no longer be subject to the exclusive use provisions of this
clause but shall instead be considered by the Administrator in accordance with the provisions of clause (i), as appropriate.
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(G) If the applicant is requesting that the registration or amendment to the registration of a pesticide be expedited, an
explanation of the basis for the request must be submitted, in accordance with paragraph (10) of this subsection.
(2) Data in support of registration
(A) In general
The Administrator shall publish guidelines specifying the kinds of information which will be required to support the
registration of a pesticide and shall revise such guidelines from time to time. If thereafter the Administrator requires any
additional kind of information under subparagraph (B) of this paragraph, the Administrator shall permit sufficient time for
applicants to obtain such additional information. The Administrator, in establishing standards for data requirements for the
registration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extent
of use, pattern of use, the public health and agricultural need for such minor use, and the level and degree of potential
beneficial or adverse effects on man and the environment. The Administrator shall not require a person to submit, in relation
to a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue data
from a geographic area where the pesticide will not be registered for such use. In the development of these standards, the
Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact
of the cost of meeting the requirements on the incentives for any potential registrant to undertake the development of the
required data. Except as provided by section 136h of this title, within 30 days after the Administrator registers a pesticide
under this subchapter the Administrator shall make available to the public the data called for in the registration statement
together with such other scientific information as the Administrator deems relevant to the Administrator's decision.
(B) Additional data
(i) If the Administrator determines that additional data are required to maintain in effect an existing registration of a
pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and
provide a list of such registrants to any interested person.
(ii) Each registrant of such pesticide shall provide evidence within ninety days after receipt of notification that it is taking
appropriate steps to secure the additional data that are required. Two or more registrants may agree to develop jointly,
or to share in the cost of developing, such data if they agree and advise the Administrator of their intent within ninety
days after notification. Any registrant who agrees to share in the cost of producing the data shall be entitled to examine
and rely upon such data in support of maintenance of such registration. The Administrator shall issue a notice of intent
to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails
to comply with this clause.
(iii) If, at the end of sixty days after advising the Administrator of their agreement to develop jointly, or share in the cost
of developing, data, the registrants have not further agreed on the terms of the data development arrangement or on a
procedure for reaching such agreement, any of such registrants may initiate binding arbitration proceedings by requesting
the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such
Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration
proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court
of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud,
misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified
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complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct.
All parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. The Administrator
shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by
clause (iv) if a registrant fails to comply with this clause.
(iv) Notwithstanding any other provision of this subchapter, if the Administrator determines that a registrant, within
the time required by the Administrator, has failed to take appropriate steps to secure the data required under this
subparagraph, to participate in a procedure for reaching agreement concerning a joint data development arrangement
under this subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the terms
of an agreement or arbitration decision concerning a joint data development arrangement under this subparagraph, the
Administrator may issue a notice of intent to suspend such registrant's registration of the pesticide for which additional
data is required. The Administrator may include in the notice of intent to suspend such provisions as the Administrator
deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Any suspension proposed
under this subparagraph shall become final and effective at the end of thirty days from receipt by the registrant of the
notice of intent to suspend, unless during that time a request for hearing is made by a person adversely affected by the
notice or the registrant has satisfied the Administrator that the registrant has complied fully with the requirements that
served as a basis for the notice of intent to suspend. If a hearing is requested, a hearing shall be conducted under section
136d(d) of this title. The only matters for resolution at that hearing shall be whether the registrant has failed to take the
action that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional data
is required, and whether the Administrator's determination with respect to the disposition of existing stocks is consistent
with this subchapter. If a hearing is held, a decision after completion of such hearing shall be final. Notwithstanding any
other provision of this subchapter, a hearing shall be held and a determination made within seventy-five days after receipt
of a request for such hearing. Any registration suspended under this subparagraph shall be reinstated by the Administrator
if the Administrator determines that the registrant has complied fully with the requirements that served as a basis for the
suspension of the registration.
(v) Any data submitted under this subparagraph shall be subject to the provisions of paragraph (1)(D). Whenever such data
are submitted jointly by two or more registrants, an agent shall be agreed on at the time of the joint submission to handle
any subsequent data compensation matters for the joint submitters of such data.
(vi) Upon the request of a registrant the Administrator shall, in the case of a minor use, extend the deadline for the
production of residue chemistry data under this subparagraph for data required solely to support that minor use until the
final deadline for submission of data under section 136a-1 of this title for the other uses of the pesticide established as
of August 3, 1996, if--
(I) the data to support other uses of the pesticide on a food are being provided;
(II) the registrant, in submitting a request for such an extension, provides a schedule, including interim dates to measure
progress, to assure that the data production will be completed before the expiration of the extension period;
(III) the Administrator has determined that such extension will not significantly delay the Administrator's schedule for
issuing a reregistration eligibility determination required under section 136a-1 of this title; and
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(IV) the Administrator has determined that based on existing data, such extension would not significantly increase the
risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this clause, the
Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for
the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule
for the production of such data, the Administrator may proceed in accordance with clause (iv) regarding the continued
registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding
the provisions of this clause, the Administrator may take action to modify or revoke the extension under this clause
if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the
environment. In such circumstance, the Administrator shall provide, in writing to the registrant, a notice revoking the
extension of time for submission of data. Such data shall instead be due in accordance with the date established by the
Administrator for the submission of the data.
(vii) If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data
in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses
and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data
in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request
of the registrant, shall not take any action pursuant to this clause in regard to such unsupported minor use until the final
deadline established as of August 3, 1996, for the submission of data under section 136a-1 of this title for the supported
uses identified pursuant to this clause unless the Administrator determines that the absence of the data is significant enough
to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the
request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in
the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported
will be voluntarily deleted from the registration pursuant to section 136d(f)(1) of this title. If the Administrator grants an
extension under this clause, the Administrator shall monitor the development of the data for the uses being supported and
shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that
the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed
in accordance with clause (iv) of this subparagraph regarding the continued registration of the affected products with
the minor and other uses and shall inform the public of such action in accordance with section 136d(f)(2) of this title.
Notwithstanding the provisions of this clause, the Administrator may deny, modify, or revoke the temporary extension
under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable
adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing,
to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall
be deleted from the registration.
(viii)(I) If data required to support registration of a pesticide under subparagraph (A) is requested by a Federal or
State regulatory authority, the Administrator shall, to the extent practicable, coordinate data requirements, test protocols,
timetables, and standards of review and reduce burdens and redundancy caused to the registrant by multiple requirements
on the registrant.
(II) The Administrator may enter into a cooperative agreement with a State to carry out subclause (I).
(III) Not later than 1 year after August 3, 1996, the Administrator shall develop a process to identify and assist in alleviating
future disparities between Federal and State data requirements.
(C) Simplified procedures
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Within nine months after September 30, 1978, the Administrator shall, by regulation, prescribe simplified procedures for
the registration of pesticides, which shall include the provisions of subparagraph (D) of this paragraph.
(D) Exemption
No applicant for registration of a pesticide who proposes to purchase a registered pesticide from another producer in order
to formulate such purchased pesticide into the pesticide that is the subject of the application shall be required to--
(i) submit or cite data pertaining to such purchased product; or
(ii) offer to pay reasonable compensation otherwise required by paragraph (1)(D) of this subsection for the use of any
such data.
(E) Minor use waiver
In handling the registration of a pesticide for a minor use, the Administrator may waive otherwise applicable data
requirements if the Administrator determines that the absence of such data will not prevent the Administrator from
determining--
(i) the incremental risk presented by the minor use of the pesticide; and
(ii) that such risk, if any, would not be an unreasonable adverse effect on the environment.
(3) Application
(A) In general
The Administrator shall review the data after receipt of the application and shall, as expeditiously as possible, either register
the pesticide in accordance with paragraph (5), or notify the applicant of the Administrator's determination that it does not
comply with the provisions of the subchapter in accordance with paragraph (6).
(B) Identical or substantially similar
(i) The Administrator shall, as expeditiously as possible, review and act on any application received by the Administrator
that--
(I) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical
or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or
that would differ in composition and labeling from such currently-registered pesticide only in ways that would not
significantly increase the risk of unreasonable adverse effects on the environment; or
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(II) proposes an amendment to the registration of a registered pesticide that does not require scientific review of data.
(ii) In expediting the review of an application for an action described in clause (i), the Administrator shall--
(I) review the application in accordance with section 136w-8(f)(4)(B) of this title and, if the application is found to be
incomplete, reject the application;
(II) not later than the applicable decision review time established pursuant to section 136w-8(f)(4)(B) of this title, or,
if no review time is established, not later than 90 days after receiving a complete application, notify the registrant if the
application has been granted or denied; and
(III) if the application is denied, notify the registrant in writing of the specific reasons for the denial of the application.
(C) Minor use registration
(i) The Administrator shall, as expeditiously as possible, review and act on any complete application--
(I) that proposes the initial registration of a new pesticide active ingredient if the active ingredient is proposed to be
registered solely for minor uses, or proposes a registration amendment solely for minor uses to an existing registration; or
(II) for a registration or a registration amendment that proposes significant minor uses.
(ii) For the purposes of clause (i)--
(I) the term as expeditiously as possible means that the Administrator shall, to the greatest extent practicable, complete
a review and evaluation of all data, submitted with a complete application, within 12 months after the submission of
the complete application, and the failure of the Administrator to complete such a review and evaluation under clause
(i) shall not be subject to judicial review; and
(II) the term significant minor uses means 3 or more minor uses proposed for every nonminor use, a minor use that
would, in the judgment of the Administrator, serve as a replacement for any use which has been canceled in the 5
years preceding the receipt of the application, or a minor use that in the opinion of the Administrator would avoid the
reissuance of an emergency exemption under section 136p of this title for that minor use.
(D) Adequate time for submission of minor use data
If a registrant makes a request for a minor use waiver, regarding data required by the Administrator, pursuant to paragraph
(2)(E), and if the Administrator denies in whole or in part such data waiver request, the registrant shall have a full-time
period for providing such data. For purposes of this subparagraph, the term full-time period means the time period
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originally established by the Administrator for submission of such data, beginning with the date of receipt by the registrant
of the Administrator's notice of denial.
(4) Notice of application
The Administrator shall publish in the Federal Register, promptly after receipt of the statement and other data required
pursuant to paragraphs (1) and (2), a notice of each application for registration of any pesticide if it contains any new active
ingredient or if it would entail a changed use pattern. The notice shall provide for a period of 30 days in which any Federal
agency or any other interested person may comment.
(5) Approval of registration
The Administrator shall register a pesticide if the Administrator determines that, when considered with any restrictions
imposed under subsection (d) of this section--
(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to be submitted comply with the requirements of this subchapter;
(C) it will perform its intended function without unreasonable adverse effects on the environment; and
(D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable
adverse effects on the environment.
The Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide. Where two
pesticides meet the requirements of this paragraph, one should not be registered in preference to the other. In considering
an application for the registration of a pesticide, the Administrator may waive data requirements pertaining to efficacy,
in which event the Administrator may register the pesticide without determining that the pesticide's composition is such
as to warrant proposed claims of efficacy. If a pesticide is found to be efficacious by any State under section 136v(c) of
this title, a presumption is established that the Administrator shall waive data requirements pertaining to efficacy for use
of the pesticide in such State.
(6) Denial of registration
If the Administrator determines that the requirements of paragraph (5) for registration are not satisfied, the Administrator
shall notify the applicant for registration of the Administrator's determination and of the Administrator's reasons (including
the factual basis) therefor, and that, unless the applicant corrects the conditions and notifies the Administrator thereof during
the 30-day period beginning with the day after the date on which the applicant receives the notice, the Administrator may
refuse to register the pesticide. Whenever the Administrator refuses to register a pesticide, the Administrator shall notify
the applicant of the Administrator's decision and of the Administrator's reasons (including the factual basis) therefor. The
Administrator shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor.
Upon such notification, the applicant for registration or other interested person with the concurrence of the applicant shall
have the same remedies as provided for in section 136d of this title.
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(7) Registration under special circumstances
Notwithstanding the provisions of paragraph (5)--
(A) The Administrator may conditionally register or amend the registration of a pesticide if the Administrator determines
that (i) the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and
use thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on
the environment, and (ii) approving the registration or amendment in the manner proposed by the applicant would not
significantly increase the risk of any unreasonable adverse effect on the environment. An applicant seeking conditional
registration or amended registration under this subparagraph shall submit such data as would be required to obtain
registration of a similar pesticide under paragraph (5). If the applicant is unable to submit an item of data because it has
not yet been generated, the Administrator may register or amend the registration of the pesticide under such conditions
as will require the submission of such data not later than the time such data are required to be submitted with respect to
similar pesticides already registered under this subchapter.
(B) The Administrator may conditionally amend the registration of a pesticide to permit additional uses of such pesticide
notwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment, if the
Administrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use,
and (ii) amending the registration in the manner proposed by the applicant would not significantly increase the risk of
any unreasonable adverse effect on the environment. Notwithstanding the foregoing provisions of this subparagraph, no
registration of a pesticide may be amended to permit an additional use of such pesticide if the Administrator has issued
a notice stating that such pesticide, or any ingredient thereof, meets or exceeds risk criteria associated in whole or in part
with human dietary exposure enumerated in regulations issued under this subchapter, and during the pendency of any risk-
benefit evaluation initiated by such notice, if (I) the additional use of such pesticide involves a major food or feed crop,
or (II) the additional use of such pesticide involves a minor food or feed crop and the Administrator determines, with the
concurrence of the Secretary of Agriculture, there is available an effective alternative pesticide that does not meet or exceed
such risk criteria. An applicant seeking amended registration under this subparagraph shall submit such data as would be
required to obtain registration of a similar pesticide under paragraph (5). If the applicant is unable to submit an item of
data (other than data pertaining to the proposed additional use) because it has not yet been generated, the Administrator
may amend the registration under such conditions as will require the submission of such data not later than the time such
data are required to be submitted with respect to similar pesticides already registered under this subchapter.
(C) The Administrator may conditionally register a pesticide containing an active ingredient not contained in any currently
registered pesticide for a period reasonably sufficient for the generation and submission of required data (which are lacking
because a period reasonably sufficient for generation of the data has not elapsed since the Administrator first imposed the
data requirement) on the condition that by the end of such period the Administrator receives such data and the data do not
meet or exceed risk criteria enumerated in regulations issued under this subchapter, and on such other conditions as the
Administrator may prescribe. A conditional registration under this subparagraph shall be granted only if the Administrator
determines that use of the pesticide during such period will not cause any unreasonable adverse effect on the environment,
and that use of the pesticide is in the public interest.
(8) Interim administrative review
Notwithstanding any other provision of this subchapter, the Administrator may not initiate a public interim administrative
review process to develop a risk-benefit evaluation of the ingredients of a pesticide or any of its uses prior to initiating a
formal action to cancel, suspend, or deny registration of such pesticide, required under this subchapter, unless such interim
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administrative process is based on a validated test or other significant evidence raising prudent concerns of unreasonable
adverse risk to man or to the environment. Notice of the definition of the terms validated test and other significant
evidence as used herein shall be published by the Administrator in the Federal Register.
(9) Labeling
(A) Additional statements
Subject to subparagraphs (B) and (C), it shall not be a violation of this subchapter for a registrant to modify the labeling
of an antimicrobial pesticide product to include relevant information on product efficacy, product composition, container
composition or design, or other characteristics that do not relate to any pesticidal claim or pesticidal activity.
(B) Requirements
Proposed labeling information under subparagraph (A) shall not be false or misleading, shall not conflict with or detract
from any statement required by law or the Administrator as a condition of registration, and shall be substantiated on the
request of the Administrator.
(C) Notification and disapproval
(i) Notification
A registration may be modified under subparagraph (A) if--
(I) the registrant notifies the Administrator in writing not later than 60 days prior to distribution or sale of a product
bearing the modified labeling; and
(II) the Administrator does not disapprove of the modification under clause (ii).
(ii) Disapproval
Not later than 30 days after receipt of a notification under clause (i), the Administrator may disapprove the modification
by sending the registrant notification in writing stating that the proposed language is not acceptable and stating the
reasons why the Administrator finds the proposed modification unacceptable.
(iii) Restriction on sale
A registrant may not sell or distribute a product bearing a disapproved modification.
(iv) Objection
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A registrant may file an objection in writing to a disapproval under clause (ii) not later than 30 days after receipt of
notification of the disapproval.
(v) Final action
A decision by the Administrator following receipt and consideration of an objection filed under clause (iv) shall be
considered a final agency action.
(D) Use dilution
The label or labeling required under this subchapter for an antimicrobial pesticide that is or may be diluted for use may
have a different statement of caution or protective measures for use of the recommended diluted solution of the pesticide
than for use of a concentrate of the pesticide if the Administrator determines that--
(i) adequate data have been submitted to support the statement proposed for the diluted solution uses; and
(ii) the label or labeling provides adequate protection for exposure to the diluted solution of the pesticide.
(10) Expedited registration of pesticides
(A) Not later than 1 year after August 3, 1996, the Administrator shall, utilizing public comment, develop procedures and
guidelines, and expedite the review of an application for registration of a pesticide or an amendment to a registration that
satisfies such guidelines.
(B) Any application for registration or an amendment, including biological and conventional pesticides, will be considered
for expedited review under this paragraph. An application for registration or an amendment shall qualify for expedited review
if use of the pesticide proposed by the application may reasonably be expected to accomplish 1 or more of the following:
(i) Reduce the risks of pesticides to human health.
(ii) Reduce the risks of pesticides to nontarget organisms.
(iii) Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources.
(iv) Broaden the adoption of integrated pest management strategies, or make such strategies more available or more
effective.
(C) The Administrator, not later than 30 days after receipt of an application for expedited review, shall notify the applicant
whether the application is complete. If it is found to be incomplete, the Administrator may either reject the request for
expedited review or ask the applicant for additional information to satisfy the guidelines developed under subparagraph (A).
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(d) Classification of pesticides
(1) Classification for general use, restricted use, or both
(A) As a part of the registration of a pesticide the Administrator shall classify it as being for general use or for restricted
use. If the Administrator determines that some of the uses for which the pesticide is registered should be for general use
and that other uses for which it is registered should be for restricted use, the Administrator shall classify it for both general
use and restricted use. Pesticide uses may be classified by regulation on the initial classification, and registered pesticides
may be classified prior to reregistration. If some of the uses of the pesticide are classified for general use, and other uses
are classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished from
those directions relating to its restricted uses. The Administrator may require that its packaging and labeling for restricted
uses shall be clearly distinguishable from its packaging and labeling for general uses.
(B) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and
cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and
commonly recognized practice, will not generally cause unreasonable adverse effects on the environment, the Administrator
will classify the pesticide, or the particular use or uses of the pesticide to which the determination applies, for general use.
(C) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and
cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and
commonly recognized practice, may generally cause, without additional regulatory restrictions, unreasonable adverse effects
on the environment, including injury to the applicator, the Administrator shall classify the pesticide, or the particular use or
uses to which the determination applies, for restricted use:
(i) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a
determination that the acute dermal or inhalation toxicity of the pesticide presents a hazard to the applicator or other
persons, the pesticide shall be applied for any use to which the restricted classification applies only by or under the direct
supervision of a certified applicator.
(ii) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of
a determination that its use without additional regulatory restriction may cause unreasonable adverse effects on the
environment, the pesticide shall be applied for any use to which the determination applies only by or under the direct
supervision of a certified applicator, or subject to such other restrictions as the Administrator may provide by regulation.
Any such regulation shall be reviewable in the appropriate court of appeals upon petition of a person adversely affected
filed within 60 days of the publication of the regulation in final form.
(2) Change in classification
If the Administrator determines that a change in the classification of any use of a pesticide from general use to restricted use
is necessary to prevent unreasonable adverse effects on the environment, the Administrator shall notify the registrant of such
pesticide of such determination at least forty-five days before making the change and shall publish the proposed change in
the Federal Register. The registrant, or other interested person with the concurrence of the registrant, may seek relief from
such determination under section 136d(b) of this title.
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(3) Change in classification from restricted use to general use
The registrant of any pesticide with one or more uses classified for restricted use may petition the Administrator to change any
such classification from restricted to general use. Such petition shall set out the basis for the registrant's position that restricted
use classification is unnecessary because classification of the pesticide for general use would not cause unreasonable adverse
effects on the environment. The Administrator, within sixty days after receiving such petition, shall notify the registrant
whether the petition has been granted or denied. Any denial shall contain an explanation therefor and any such denial shall
be subject to judicial review under section 136n of this title.
(e) Products with same formulation and claims
Products which have the same formulation, are manufactured by the same person, the labeling of which contains the same
claims, and the labels of which bear a designation identifying the product as the same pesticide may be registered as a single
pesticide; and additional names and labels shall be added to the registration by supplemental statements.
(f) Miscellaneous
(1) Effect of change of labeling or formulation
If the labeling or formulation for a pesticide is changed, the registration shall be amended to reflect such change if the
Administrator determines that the change will not violate any provision of this subchapter.
(2) Registration not a defense
In no event shall registration of an article be construed as a defense for the commission of any offense under this subchapter.
As long as no cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence that the pesticide,
its labeling and packaging comply with the registration provisions of the subchapter.
(3) Authority to consult other Federal agencies
In connection with consideration of any registration or application for registration under this section, the Administrator may
consult with any other Federal agency.
(4) Mixtures of nitrogen stabilizers and fertilizer products
Any mixture or other combination of--
(A) 1 or more nitrogen stabilizers registered under this subchapter; and
(B) 1 or more fertilizer products,
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shall not be subject to the provisions of this section or sections 136a-1, 136c, 136e, 136m, and 136o(a)(2) of this title if
the mixture or other combination is accompanied by the labeling required under this subchapter for the nitrogen stabilizer
contained in the mixture or other combination, the mixture or combination is mixed or combined in accordance with such
labeling, and the mixture or combination does not contain any active ingredient other than the nitrogen stabilizer.
(g) Registration review
(1) General rule
(A) Periodic review
(i) In general
The registrations of pesticides are to be periodically reviewed.
(ii) Regulations
In accordance with this subparagraph, the Administrator shall by regulation establish a procedure for accomplishing
the periodic review of registrations.
(iii) Initial registration review
The Administrator shall complete the registration review of each pesticide or pesticide case, which may be composed
of 1 or more active ingredients and the products associated with the active ingredients, not later than the later of--
(I) October 1, 2022; or
(II) the date that is 15 years after the date on which the first pesticide containing a new active ingredient is registered.
(iv) Subsequent registration review
Not later than 15 years after the date on which the initial registration review is completed under clause (iii) and each 15
years thereafter, the Administrator shall complete a subsequent registration review for each pesticide or pesticide case.
(v) Cancellation
No registration shall be canceled as a result of the registration review process unless the Administrator follows the
procedures and substantive requirements of section 136d of this title.
(B) Docketing
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(i) In general
Subject to clause (ii), after meeting with 1 or more individuals that are not government employees to discuss matters
relating to a registration review, the Administrator shall place in the docket minutes of the meeting, a list of attendees,
and any documents exchanged at the meeting, not later than the earlier of--
(I) the date that is 45 days after the meeting; or
(II) the date of issuance of the registration review decision.
(ii) Protected information
The Administrator shall identify, but not include in the docket, any confidential business information the disclosure of
which is prohibited by section 136h of this title.
(C) Limitation
Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant to
this subchapter.
(2) Data
(A) Submission required
The Administrator shall use the authority in subsection (c)(2)(B) of this section to require the submission of data when
such data are necessary for a registration review.
(B) Data submission, compensation, and exemption
For purposes of this subsection, the provisions of subsections (c)(1), (c)(2)(B), and (c)(2)(D) of this section shall be utilized
for and be applicable to any data required for registration review.
(h) Registration requirements for antimicrobial pesticides
(1) Evaluation of process
To the maximum extent practicable consistent with the degrees of risk presented by an antimicrobial pesticide and the type of
review appropriate to evaluate the risks, the Administrator shall identify and evaluate reforms to the antimicrobial registration
process that would reduce review periods existing as of August 3, 1996, for antimicrobial pesticide product registration
applications and applications for amended registration of antimicrobial pesticide products, including--
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(A) new antimicrobial active ingredients;
(B) new antimicrobial end-use products;
(C) substantially similar or identical antimicrobial pesticides; and
(D) amendments to antimicrobial pesticide registrations.
(2) Review time period reduction goal
Each reform identified under paragraph (1) shall be designed to achieve the goal of reducing the review period following
submission of a complete application, consistent with the degree of risk, to a period of not more than--
(A) 540 days for a new antimicrobial active ingredient pesticide registration;
(B) 270 days for a new antimicrobial use of a registered active ingredient;
(C) 120 days for any other new antimicrobial product;
(D) 90 days for a substantially similar or identical antimicrobial product;
(E) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and
(F) 120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not
otherwise described in this paragraph.
(3) Implementation
(A) Proposed rulemaking
(i) Issuance
Not later than 270 days after August 3, 1996, the Administrator shall publish in the Federal Register proposed regulations
to accelerate and improve the review of antimicrobial pesticide products designed to implement, to the extent practicable,
the goals set forth in paragraph (2).
(ii) Requirements
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Proposed regulations issued under clause (i) shall--
(I) define the various classes of antimicrobial use patterns, including household, industrial, and institutional
disinfectants and sanitizing pesticides, preservatives, water treatment, and pulp and paper mill additives, and other
such products intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms,
or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances from
contamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime;
(II) differentiate the types of review undertaken for antimicrobial pesticides;
(III) conform the degree and type of review to the risks and benefits presented by antimicrobial pesticides and the
function of review under this subchapter, considering the use patterns of the product, toxicity, expected exposure,
and product type;
(IV) ensure that the registration process is sufficient to maintain antimicrobial pesticide efficacy and that antimicrobial
pesticide products continue to meet product performance standards and effectiveness levels for each type of label
claim made; and
(V) implement effective and reliable deadlines for process management.
(iii) Comments
In developing the proposed regulations, the Administrator shall solicit the views from registrants and other affected
parties to maximize the effectiveness of the rule development process.
(B) Final regulations
(i) Issuance
The Administrator shall issue final regulations not later than 240 days after the close of the comment period for the
proposed regulations.
(ii) Failure to meet goal
If a goal described in paragraph (2) is not met by the final regulations, the Administrator shall identify the goal, explain
why the goal was not attained, describe the element of the regulations included instead, and identify future steps to
attain the goal.
(iii) Requirements
In issuing final regulations, the Administrator shall--
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(I) consider the establishment of a certification process for regulatory actions involving risks that can be responsibly
managed, consistent with the degree of risk, in the most cost-efficient manner;
(II) consider the establishment of a certification process by approved laboratories as an adjunct to the review process;
(III) use all appropriate and cost-effective review mechanisms, including--
(aa) expanded use of notification and non-notification procedures;
(bb) revised procedures for application review; and
(cc) allocation of appropriate resources to ensure streamlined management of antimicrobial pesticide registrations;
and
(IV) clarify criteria for determination of the completeness of an application.
(C) Expedited review
This subsection does not affect the requirements or extend the deadlines or review periods contained in subsection (c)
(3) of this section.
(D) Alternative review periods
If the final regulations to carry out this paragraph are not effective 630 days after August 3, 1996, until the final regulations
become effective, the review period, beginning on the date of receipt by the Agency of a complete application, shall be--
(i) 2 years for a new antimicrobial active ingredient pesticide registration;
(ii) 1 year for a new antimicrobial use of a registered active ingredient;
(iii) 180 days for any other new antimicrobial product;
(iv) 90 days for a substantially similar or identical antimicrobial product;
(v) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and
(vi) 120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is not
otherwise described in this subparagraph.
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(E) Wood preservatives
An application for the registration, or for an amendment to the registration, of a wood preservative product for which a
claim of pesticidal activity listed in section 136(mm) of this title is made (regardless of any other pesticidal claim that is
made with respect to the product) shall be reviewed by the Administrator within the same period as that established under
this paragraph for an antimicrobial pesticide product application, consistent with the degree of risk posed by the use of the
wood preservative product, if the application requires the applicant to satisfy the same data requirements as are required
to support an application for a wood preservative product that is an antimicrobial pesticide.
(F) Notification
(i) In general
Subject to clause (iii), the Administrator shall notify an applicant whether an application has been granted or denied not
later than the final day of the appropriate review period under this paragraph, unless the applicant and the Administrator
agree to a later date.
(ii) Final decision
If the Administrator fails to notify an applicant within the period of time required under clause (i), the failure shall be
considered an agency action unlawfully withheld or unreasonably delayed for purposes of judicial review under chapter
7 of Title 5.
(iii) Exemption
This subparagraph does not apply to an application for an antimicrobial pesticide that is filed under subsection (c)(3)
(B) of this section prior to 90 days after August 3, 1996.
(iv) Limitation
Notwithstanding clause (ii), the failure of the Administrator to notify an applicant for an amendment to a registration
for an antimicrobial pesticide shall not be judicially reviewable in a Federal or State court if the amendment requires
scientific review of data within--
(I) the time period specified in subparagraph (D)(vi), in the absence of a final regulation under subparagraph (B); or
(II) the time period specified in paragraph (2)(F), if adopted in a final regulation under subparagraph (B).
(4) Annual report
(A) Submission
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Beginning on August 3, 1996, and ending on the date that the goals under paragraph (2) are achieved, the Administrator
shall, not later than March 1 of each year, prepare and submit an annual report to the Committee on Agriculture of the
House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate.
(B) Requirements
A report submitted under subparagraph (A) shall include a description of--
(i) measures taken to reduce the backlog of pending registration applications;
(ii) progress toward achieving reforms under this subsection; and
(iii) recommendations to improve the activities of the Agency pertaining to antimicrobial registrations.
Credits
(June 25, 1947, c. 125, 3, as added Oct. 21, 1972, Pub.L. 92-516, 2, 86 Stat. 979; amended Nov. 28, 1975, Pub.L. 94-140,
12, 89 Stat. 755; Sept. 30, 1978, Pub.L. 95-396, 2(a), 3-8, 92 Stat. 820, 824-827; Oct. 25, 1988, Pub.L. 100-532, Title I,
102(b), 103, Title VI, 601(b)(1), Title VIII, 801(b), 102 Stat. 2667, 2677, 2680; Nov. 28, 1990, Pub.L. 101-624, Title
XIV, 1492, 104 Stat. 3628; Dec. 13, 1991, Pub.L. 102-237, Title X, 1006(a)(3), (b)(1), (2), (c), 105 Stat. 1894 to 1896;
Aug. 3, 1996, Pub.L. 104-170, Title I, 105(b), 106(b), Title II, 210(b), (c)(1), (d), (e), (f)(2), 222 to 224, 231, 250, 110
Stat. 1491, 1494 to 1497, 1499, 1503, 1504, 1508, 1510; Jan. 23, 2004, Pub.L. 108-199, Div. G, Title V, 501(b), 118 Stat.
419; Oct. 9, 2007, Pub.L. 110-94, 2, 3, 121 Stat. 1000.)
Notes of Decisions (90)
7 U.S.C.A. 136a, 7 USCA 136a
Current through P.L. 112-197 approved 11-27-12
End of Document 2012 Thomson Reuters. No claim to original U.S. Government Works.
SPA-084
342. Adulterated food, 21 USCA 342
2012 Thomson Reuters. No claim to original U.S. Government Works. 1
UnILed SLuLes Code AnnoLuLed
TILIe z1. ood und Drugs (ReIs & Annos)
ChuLer q. ederuI ood, Drug, und CosmeLIc AcL (ReIs & Annos)
SubchuLer V. ood
z1 U.S.C.A. qz
qz. AduILeruLed Iood
EIIecLIve: OcLober 1, zoo
CurrenLness
A food shall be deemed to be adulterated--
(a) Poisonous, insanitary, etc., ingredients
(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it injurious to health.
1
(2)(A) if it bears or contains any added poisonous or
added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity
or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346
of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a)
of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 of
this title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of this
title; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;
or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased
animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of
any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally
subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant
to section 348 of this title.
(b) Absence, substitution, or addition of constituents
(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance
has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength,
or make it appear better or of greater value than it is.
(c) Color additives
If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.
(d) Confectionery containing alcohol or nonnutritive substance
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If it is confectionery, and--
(1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply
in the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is of
practical functional value to the confectionery product and would not render the product injurious or hazardous to health;
(2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely
from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or delivered
for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted
under the laws of the State in which such confectionery is intended to be offered for sale; or
(3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive
substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture,
packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or
otherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the Secretary may,
for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph, issue regulations allowing
or prohibiting the use of particular nonnutritive substances.
(e) Oleomargarine containing filthy, putrid, etc., matter
If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any
filthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for food.
(f) Dietary supplement or ingredient: safety
(1) If it is a dietary supplement or contains a dietary ingredient that--
(A) presents a significant or unreasonable risk of illness or injury under--
(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;
(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such
ingredient does not present a significant or unreasonable risk of illness or injury;
(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make
such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in
accordance with sections 554 and 556 of Title 5 to affirm or withdraw the declaration; or
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(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use
recommended or suggested in the labeling of such dietary supplement.
In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that
a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.
(2) Before the Secretary may report to a United States attorney a violation of paragraph
2
(1)(A) for a civil proceeding, the
person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present
views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.
(g) Dietary supplement: manufacturing practices
(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good
manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the
Secretary under subparagraph (2).
(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall
be modeled after current good manufacturing practice regulations for food and may not impose standards for which there
is no current and generally available analytical methodology. No standard of current good manufacturing practice may be
imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance
with chapter 5 of Title 5.
(h) If it is an article of food imported or offered for import into the United States and the article of food has previously been
refused admission under section 381(a) of this title, unless the person reoffering the article affirmatively establishes, at the
expense of the owner or consignee of the article, that the article complies with the applicable requirements of this chapter, as
determined by the Secretary.
(i) If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person
engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section
350e of this title.
Credits
(June 25, 1938, c. 675, 402, 52 Stat. 1046; 1940 Reorg. Plan No. IV, 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; Mar.
16, 1950, c. 61, 3(d), 64 Stat. 21; 1953 Reorg. Plan No. 1, 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; July 22, 1954, c.
559, 2, 68 Stat. 511; July 9, 1956, c. 530, 70 Stat. 512; Sept. 6, 1958, Pub.L. 85-929, 3(a), (b), 72 Stat. 1784; Mar. 17, 1959,
Pub.L. 86-2, 73 Stat. 3; July 12, 1960, Pub.L. 86-618, Title I, 102(a)(1), (2), 105(c), 74 Stat. 397, 398, 404; June 29, 1966,
Pub.L. 89-477, 80 Stat. 231; July 13, 1968, Pub.L. 90-399, 104, 82 Stat. 352; Feb. 27, 1986, Pub.L. 99-252, 10, 100 Stat.
35; Oct. 29, 1992, Pub.L. 102-571, Title I, 107(4), 106 Stat. 4499; Aug. 13, 1993, Pub.L. 103-80, 3(i), 107 Stat. 776; Oct.
25, 1994, Pub.L. 103-417, 4, 9, 108 Stat. 4328, 4332; Aug. 3, 1996, Pub.L. 104-170, Title IV, 404, 110 Stat. 1514; June
12, 2002, Pub.L. 107-188, Title III, 309, 116 Stat. 673; Aug. 10, 2005, Pub.L. 109-59, Title VII, 7202(a), 119 Stat. 1911.)
Notes of Decisions (291)
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Footnotes
1 So in original. Probably should be ; or.
2 So in original. Probably should be subparagraph.
21 U.S.C.A. 342, 21 USCA 342
Current through P.L. 112-197 approved 11-27-12
End of Document 2012 Thomson Reuters. No claim to original U.S. Government Works.
SPA-088
346a. Tolerances and exemptions for pesticide chemical residues, 21 USCA 346a
2012 Thomson Reuters. No claim to original U.S. Government Works. 1
UnILed SLuLes Code AnnoLuLed
TILIe z1. ood und Drugs (ReIs & Annos)
ChuLer q. ederuI ood, Drug, und CosmeLIc AcL (ReIs & Annos)
SubchuLer V. ood
z1 U.S.C.A. q6u
q6u. ToIerunces und exemLIons Ior esLIcIde chemIcuI resIdues
EIIecLIve: OcLober 1, zo1z
CurrenLness
(a) Requirement for tolerance or exemption
(1) General rule
Except as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed unsafe for the
purpose of section 342(a)(2)(B) of this title unless--
(A) a tolerance for such pesticide chemical residue in or on such food is in effect under this section and the quantity of
the residue is within the limits of the tolerance; or
(B) an exemption from the requirement of a tolerance is in effect under this section for the pesticide chemical residue.
For the purposes of this section, the term food, when used as a noun without modification, shall mean a raw agricultural
commodity or processed food.
(2) Processed food
Notwithstanding paragraph (1)--
(A) if a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a
pesticide chemical residue that is present in or on a processed food because the food is made from that raw agricultural
commodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title despite the lack of a
tolerance for the pesticide chemical residue in or on the processed food if the pesticide chemical has been used in or on the
raw agricultural commodity in conformity with a tolerance under this section, such residue in or on the raw agricultural
commodity has been removed to the extent possible in good manufacturing practice, and the concentration of the pesticide
chemical residue in the processed food is not greater than the tolerance prescribed for the pesticide chemical residue in
the raw agricultural commodity; or
(B) if an exemption for the requirement for a tolerance is in effect under this section for a pesticide chemical residue in
or on a raw agricultural commodity, a pesticide chemical residue that is present in or on a processed food because the
food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of section 342(a)
(2)(B) of this title.
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(3) Residues of degradation products
If a pesticide chemical residue is present in or on a food because it is a metabolite or other degradation product of a precursor
substance that itself is a pesticide chemical or pesticide chemical residue, such a residue shall not be considered to be unsafe
within the meaning of section 342(a)(2)(B) of this title despite the lack of a tolerance or exemption from the need for a
tolerance for such residue in or on such food if--
(A) the Administrator has not determined that the degradation product is likely to pose any potential health risk from
dietary exposure that is of a different type than, or of a greater significance than, any risk posed by dietary exposure to
the precursor substance;
(B) either--
(i) a tolerance is in effect under this section for residues of the precursor substance in or on the food, and the
combined level of residues of the degradation product and the precursor substance in or on the food is at or below the
stoichiometrically equivalent level that would be permitted by the tolerance if the residue consisted only of the precursor
substance rather than the degradation product; or
(ii) an exemption from the need for a tolerance is in effect under this section for residues of the precursor substance
in or on the food; and
(C) the tolerance or exemption for residues of the precursor substance does not state that it applies only to particular named
substances and does not state that it does not apply to residues of the degradation product.
(4) Effect of tolerance or exemption
While a tolerance or exemption from the requirement for a tolerance is in effect under this section for a pesticide chemical
residue with respect to any food, the food shall not by reason of bearing or containing any amount of such a residue be
considered to be adulterated within the meaning of section 342(a)(1) of this title.
(b) Authority and standard for tolerance
(1) Authority
The Administrator may issue regulations establishing, modifying, or revoking a tolerance for a pesticide chemical residue
in or on a food--
(A) in response to a petition filed under subsection (d) of this section; or
(B) on the Administrator's own initiative under subsection (e) of this section.
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As used in this section, the term modify shall not mean expanding the tolerance to cover additional foods.
(2) Standard
(A) General rule
(i) Standard
The Administrator may establish or leave in effect a tolerance for a pesticide chemical residue in or on a food only
if the Administrator determines that the tolerance is safe. The Administrator shall modify or revoke a tolerance if the
Administrator determines it is not safe.
(ii) Determination of safety
As used in this section, the term safe, with respect to a tolerance for a pesticide chemical residue, means that the
Administrator has determined that there is a reasonable certainty that no harm will result from aggregate exposure to
the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is
reliable information.
(iii) Rule of construction
With respect to a tolerance, a pesticide chemical residue meeting the standard under clause (i) is not an eligible pesticide
chemical residue for purposes of subparagraph (B).
(B) Tolerances for eligible pesticide chemical residues
(i) Definition
As used in this subparagraph, the term eligible pesticide chemical residue means a pesticide chemical residue as to
which--
(I) the Administrator is not able to identify a level of exposure to the residue at which the residue will not cause or
contribute to a known or anticipated harm to human health (referred to in this section as a nonthreshold effect);
(II) the lifetime risk of experiencing the nonthreshold effect is appropriately assessed by quantitative risk assessment;
and
(III) with regard to any known or anticipated harm to human health for which the Administrator is able to identify
a level at which the residue will not cause such harm (referred to in this section as a threshold effect), the
Administrator determines that the level of aggregate exposure is safe.
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(ii) Determination of tolerance
Notwithstanding subparagraph (A)(i), a tolerance for an eligible pesticide chemical residue may be left in effect or
modified under this subparagraph if--
(I) at least one of the conditions described in clause (iii) is met; and
(II) both of the conditions described in clause (iv) are met.
(iii) Conditions regarding use
For purposes of clause (ii), the conditions described in this clause with respect to a tolerance for an eligible pesticide
chemical residue are the following:
(I) Use of the pesticide chemical that produces the residue protects consumers from adverse effects on health that
would pose a greater risk than the dietary risk from the residue.
(II) Use of the pesticide chemical that produces the residue is necessary to avoid a significant disruption in domestic
production of an adequate, wholesome, and economical food supply.
(iv) Conditions regarding risk
For purposes of clause (ii), the conditions described in this clause with respect to a tolerance for an eligible pesticide
chemical residue are the following:
(I) The yearly risk associated with the nonthreshold effect from aggregate exposure to the residue does not exceed
10 times the yearly risk that would be allowed under subparagraph (A) for such effect.
(II) The tolerance is limited so as to ensure that the risk over a lifetime associated with the nonthreshold effect from
aggregate exposure to the residue is not greater than twice the lifetime risk that would be allowed under subparagraph
(A) for such effect.
(v) Review
Five years after the date on which the Administrator makes a determination to leave in effect or modify a tolerance
under this subparagraph, and thereafter as the Administrator deems appropriate, the Administrator shall determine, after
notice and opportunity for comment, whether it has been demonstrated to the Administrator that a condition described
in clause (iii)(I) or clause (iii)(II) continues to exist with respect to the tolerance and that the yearly and lifetime risks
from aggregate exposure to such residue continue to comply with the limits specified in clause (iv). If the Administrator
determines by such date that such demonstration has not been made, the Administrator shall, not later than 180 days
after the date of such determination, issue a regulation under subsection (e)(1) of this section to modify or revoke the
tolerance.
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(vi) Infants and children
Any tolerance under this subparagraph shall meet the requirements of subparagraph (C).
(C) Exposure of infants and children
In establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, the
Administrator--
(i) shall assess the risk of the pesticide chemical residue based on--
(I) available information about consumption patterns among infants and children that are likely to result in
disproportionately high consumption of foods containing or bearing such residue among infants and children in
comparison to the general population;
(II) available information concerning the special susceptibility of infants and children to the pesticide chemical
residues, including neurological differences between infants and children and adults, and effects of in utero exposure
to pesticide chemicals; and
(III) available information concerning the cumulative effects on infants and children of such residues and other
substances that have a common mechanism of toxicity; and
(ii) shall--
(I) ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure
to the pesticide chemical residue; and
(II) publish a specific determination regarding the safety of the pesticide chemical residue for infants and children.
The Secretary of Health and Human Services and the Secretary of Agriculture, in consultation with the Administrator,
shall conduct surveys to document dietary exposure to pesticides among infants and children. In the case of threshold
effects, for purposes of clause (ii)(I) an additional tenfold margin of safety for the pesticide chemical residue and
other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal
toxicity and completeness of the data with respect to exposure and toxicity to infants and children. Notwithstanding
such requirement for an additional margin of safety, the Administrator may use a different margin of safety for the
pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.
(D) Factors
In establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, the
Administrator shall consider, among other relevant factors--
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(i) the validity, completeness, and reliability of the available data from studies of the pesticide chemical and pesticide
chemical residue;
(ii) the nature of any toxic effect shown to be caused by the pesticide chemical or pesticide chemical residue in such
studies;
(iii) available information concerning the relationship of the results of such studies to human risk;
(iv) available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups
of consumers);
(v) available information concerning the cumulative effects of such residues and other substances that have a common
mechanism of toxicity;
(vi) available information concerning the aggregate exposure levels of consumers (and major identifiable subgroups
of consumers) to the pesticide chemical residue and to other related substances, including dietary exposure under the
tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupational
sources;
(vii) available information concerning the variability of the sensitivities of major identifiable subgroups of consumers;
(viii) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects; and
(ix) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety
of food additives are generally recognized as appropriate for the use of animal experimentation data.
(E) Data and information regarding anticipated and actual residue levels
(i) Authority
In establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide chemical residue, the Administrator
may consider available data and information on the anticipated residue levels of the pesticide chemical in or on food
and the actual residue levels of the pesticide chemical that have been measured in food, including residue data collected
by the Food and Drug Administration.
(ii) Requirement
If the Administrator relies on anticipated or actual residue levels in establishing, modifying, or leaving in effect a
tolerance, the Administrator shall pursuant to subsection (f)(1) of this section require that data be provided five years
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after the date on which the tolerance is established, modified, or left in effect, and thereafter as the Administrator deems
appropriate, demonstrating that such residue levels are not above the levels so relied on. If such data are not so provided,
or if the data do not demonstrate that the residue levels are not above the levels so relied on, the Administrator shall, not
later than 180 days after the date on which the data were required to be provided, issue a regulation under subsection (e)
(1) of this section, or an order under subsection (f)(2) of this section, as appropriate, to modify or revoke the tolerance.
(F) Percent of food actually treated
In establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide chemical residue, the Administrator
may, when assessing chronic dietary risk, consider available data and information on the percent of food actually treated
with the pesticide chemical (including aggregate pesticide use data collected by the Department of Agriculture) only if
the Administrator--
(i) finds that the data are reliable and provide a valid basis to show what percentage of the food derived from such crop
is likely to contain such pesticide chemical residue;
(ii) finds that the exposure estimate does not understate exposure for any significant subpopulation group;
(iii) finds that, if data are available on pesticide use and consumption of food in a particular area, the population in such
area is not dietarily exposed to residues above those estimated by the Administrator; and
(iv) provides for the periodic reevaluation of the estimate of anticipated dietary exposure.
(3) Detection methods
(A) General rule
A tolerance for a pesticide chemical residue in or on a food shall not be established or modified by the Administrator
unless the Administrator determines, after consultation with the Secretary, that there is a practical method for detecting
and measuring the levels of the pesticide chemical residue in or on the food.
(B) Detection limit
A tolerance for a pesticide chemical residue in or on a food shall not be established at or modified to a level lower than the
limit of detection of the method for detecting and measuring the pesticide chemical residue specified by the Administrator
under subparagraph (A).
(4) International standards
In establishing a tolerance for a pesticide chemical residue in or on a food, the Administrator shall determine whether a
maximum residue level for the pesticide chemical has been established by the Codex Alimentarius Commission. If a Codex
maximum residue level has been established for the pesticide chemical and the Administrator does not propose to adopt
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the Codex level, the Administrator shall publish for public comment a notice explaining the reasons for departing from the
Codex level.
(c) Authority and standard for exemptions
(1) Authority
The Administrator may issue a regulation establishing, modifying, or revoking an exemption from the requirement for a
tolerance for a pesticide chemical residue in or on food--
(A) in response to a petition filed under subsection (d) of this section; or
(B) on the Administrator's initiative under subsection (e) of this section.
(2) Standard
(A) General rule
(i) Standard
The Administrator may establish or leave in effect an exemption from the requirement for a tolerance for a pesticide
chemical residue in or on food only if the Administrator determines that the exemption is safe. The Administrator shall
modify or revoke an exemption if the Administrator determines it is not safe.
(ii) Determination of safety
The term safe, with respect to an exemption for a pesticide chemical residue, means that the Administrator has
determined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.
(B) Factors
In making a determination under this paragraph, the Administrator shall take into account, among other relevant
considerations, the considerations set forth in subparagraphs (C) and (D) of subsection (b)(2) of this section.
(3) Limitation
An exemption from the requirement for a tolerance for a pesticide chemical residue in or on food shall not be established or
modified by the Administrator unless the Administrator determines, after consultation with the Secretary--
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(A) that there is a practical method for detecting and measuring the levels of such pesticide chemical residue in or on
food; or
(B) that there is no need for such a method, and states the reasons for such determination in issuing the regulation
establishing or modifying the exemption.
(d) Petition for tolerance or exemption
(1) Petitions and petitioners
Any person may file with the Administrator a petition proposing the issuance of a regulation--
(A) establishing, modifying, or revoking a tolerance for a pesticide chemical residue in or on a food; or
(B) establishing, modifying, or revoking an exemption from the requirement of a tolerance for such a residue.
(2) Petition contents
(A) Establishment
A petition under paragraph (1) to establish a tolerance or exemption for a pesticide chemical residue shall be supported by
such data and information as are specified in regulations issued by the Administrator, including--
(i)(I) an informative summary of the petition and of the data, information, and arguments submitted or cited in support
of the petition; and
(II) a statement that the petitioner agrees that such summary or any information it contains may be published as a part
of the notice of filing of the petition to be published under this subsection and as part of a proposed or final regulation
issued under this section;
(ii) the name, chemical identity, and composition of the pesticide chemical residue and of the pesticide chemical that
produces the residue;
(iii) data showing the recommended amount, frequency, method, and time of application of that pesticide chemical;
(iv) full reports of tests and investigations made with respect to the safety of the pesticide chemical, including full
information as to the methods and controls used in conducting those tests and investigations;
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(v) full reports of tests and investigations made with respect to the nature and amount of the pesticide chemical residue
that is likely to remain in or on the food, including a description of the analytical methods used;
(vi) a practical method for detecting and measuring the levels of the pesticide chemical residue in or on the food, or for
exemptions, a statement why such a method is not needed;
(vii) a proposed tolerance for the pesticide chemical residue, if a tolerance is proposed;
(viii) if the petition relates to a tolerance for a processed food, reports of investigations conducted using the processing
method(s) used to produce that food;
(ix) such information as the Administrator may require to make the determination under subsection (b)(2)(C) of this
section;
(x) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects;
(xi) information regarding exposure to the pesticide chemical residue due to any tolerance or exemption already granted
for such residue;
(xii) practical methods for removing any amount of the residue that would exceed any proposed tolerance; and
(xiii) such other data and information as the Administrator requires by regulation to support the petition.
If information or data required by this subparagraph is available to the Administrator, the person submitting the
petition may cite the availability of the information or data in lieu of submitting it. The Administrator may require a
petition to be accompanied by samples of the pesticide chemical with respect to which the petition is filed.
(B) Modification or revocation
The Administrator may by regulation establish the requirements for information and data to support a petition to modify
or revoke a tolerance or to modify or revoke an exemption from the requirement for a tolerance.
(3) Notice
A notice of the filing of a petition that the Administrator determines has met the requirements of paragraph (2) shall be
published by the Administrator within 30 days after such determination. The notice shall announce the availability of a
description of the analytical methods available to the Administrator for the detection and measurement of the pesticide
chemical residue with respect to which the petition is filed or shall set forth the petitioner's statement of why such a method
is not needed. The notice shall include the summary required by paragraph (2)(A)(i)(I).
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(4) Actions by the Administrator
(A) In general
The Administrator shall, after giving due consideration to a petition filed under paragraph (1) and any other information
available to the Administrator--
(i) issue a final regulation (which may vary from that sought by the petition) establishing, modifying, or revoking a
tolerance for the pesticide chemical residue or an exemption of the pesticide chemical residue from the requirement of a
tolerance (which final regulation shall be issued without further notice and without further period for public comment);
(ii) issue a proposed regulation under subsection (e) of this section, and thereafter issue a final regulation under such
subsection; or
(iii) issue an order denying the petition.
(B) Priorities
The Administrator shall give priority to petitions for the establishment or modification of a tolerance or exemption for
a pesticide chemical residue that appears to pose a significantly lower risk to human health from dietary exposure than
pesticide chemical residues that have tolerances in effect for the same or similar uses.
(C) Expedited review of certain petitions
(i) Date certain for review
If a person files a complete petition with the Administrator proposing the issuance of a regulation establishing a tolerance
or exemption for a pesticide chemical residue that presents a lower risk to human health than a pesticide chemical residue
for which a tolerance has been left in effect or modified under subsection (b)(2)(B) of this section, the Administrator
shall complete action on such petition under this paragraph within 1 year.
(ii) Required determinations
If the Administrator issues a final regulation establishing a tolerance or exemption for a safer pesticide chemical residue
under clause (i), the Administrator shall, not later than 180 days after the date on which the regulation is issued, determine
whether a condition described in subclause (I) or (II) of subsection (b)(2)(B)(iii) of this section continues to exist with
respect to a tolerance that has been left in effect or modified under subsection (b)(2)(B) of this section. If such condition
does not continue to exist, the Administrator shall, not later than 180 days after the date on which the determination
under the preceding sentence is made, issue a regulation under subsection (e)(1) of this section to modify or revoke
the tolerance.
(e) Action on Administrator's own initiative
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(1) General rule
The Administrator may issue a regulation--
(A) establishing, modifying, suspending under subsection (l)(3) of this section, or revoking a tolerance for a pesticide
chemical or a pesticide chemical residue;
(B) establishing, modifying, suspending under subsection (l)(3) of this section, or revoking an exemption of a pesticide
chemical residue from the requirement of a tolerance; or
(C) establishing general procedures and requirements to implement this section.
(2) Notice
Before issuing a final regulation under paragraph (1), the Administrator shall issue a notice of proposed rulemaking and
provide a period of not less than 60 days for public comment on the proposed regulation, except that a shorter period for
comment may be provided if the Administrator for good cause finds that it would be in the public interest to do so and states
the reasons for the finding in the notice of proposed rulemaking.
(f) Special data requirements
(1) Requiring submission of additional data
If the Administrator determines that additional data or information are reasonably required to support the continuation of a
tolerance or exemption that is in effect under this section for a pesticide chemical residue on a food, the Administrator shall--
(A) issue a notice requiring the person holding the pesticide registrations associated with such tolerance or exemption
to submit the data or information under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act [7
U.S.C.A. 136a(c)(2)(B)];
(B) issue a rule requiring that testing be conducted on a substance or mixture under section 4 of the Toxic Substances
Control Act [15 U.S.C.A. 2603]; or
(C) publish in the Federal Register, after first providing notice and an opportunity for comment of not less than 60 days'
duration, an order--
(i) requiring the submission to the Administrator by one or more interested persons of a notice identifying the person
or persons who will submit the required data and information;
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(ii) describing the type of data and information required to be submitted to the Administrator and stating why the data
and information could not be obtained under the authority of section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C.A. 136a(c)(2)(B)] or section 4 of the Toxic Substances Control Act [15 U.S.C.A. 2603];
(iii) describing the reports of the Administrator required to be prepared during and after the collection of the data and
information;
(iv) requiring the submission to the Administrator of the data, information, and reports referred to in clauses (ii) and
(iii); and
(v) establishing dates by which the submissions described in clauses (i) and (iv) must be made.
The Administrator may under subparagraph (C) revise any such order to correct an error. The Administrator may
under this paragraph require data or information pertaining to whether the pesticide chemical may have an effect in
humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.
(2) Noncompliance
If a submission required by a notice issued in accordance with paragraph (1)(A), a rule issued under paragraph (1)(B), or
an order issued under paragraph (1)(C) is not made by the time specified in such notice, rule, or order, the Administrator
may by order published in the Federal Register modify or revoke the tolerance or exemption in question. In any review of
such an order under subsection (g)(2) of this section, the only material issue shall be whether a submission required under
paragraph (1) was not made by the time specified.
(g) Effective date, objections, hearings, and administrative review
(1) Effective date
A regulation or order issued under subsection (d)(4), (e)(1), or (f)(2) of this section shall take effect upon publication unless
the regulation or order specifies otherwise. The Administrator may stay the effectiveness of the regulation or order if, after
issuance of such regulation or order, objections are filed with respect to such regulation or order pursuant to paragraph (2).
(2) Further proceedings
(A) Objections
Within 60 days after a regulation or order is issued under subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C)
of this section, any person may file objections thereto with the Administrator, specifying with particularity the provisions
of the regulation or order deemed objectionable and stating reasonable grounds therefor. If the regulation or order was
issued in response to a petition under subsection (d)(1) of this section, a copy of each objection filed by a person other
than the petitioner shall be served by the Administrator on the petitioner.
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(B) Hearing
An objection may include a request for a public evidentiary hearing upon the objection. The Administrator shall, upon the
initiative of the Administrator or upon the request of an interested person and after due notice, hold a public evidentiary
hearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence
relevant to material issues of fact raised by the objections. The presiding officer in such a hearing may authorize a party to
obtain discovery from other persons and may upon a showing of good cause made by a party issue a subpoena to compel
testimony or production of documents from any person. The presiding officer shall be governed by the Federal Rules of
Civil Procedure in making any order for the protection of the witness or the content of documents produced and shall
order the payment of reasonable fees and expenses as a condition to requiring testimony of the witness. On contest, such
a subpoena may be enforced by a Federal district court.
(C) Final decision
As soon as practicable after receiving the arguments of the parties, the Administrator shall issue an order stating the action
taken upon each such objection and setting forth any revision to the regulation or prior order that the Administrator has
found to be warranted. If a hearing was held under subparagraph (B), such order and any revision to the regulation or prior
order shall, with respect to questions of fact at issue in the hearing, be based only on substantial evidence of record at
such hearing, and shall set forth in detail the findings of facts and the conclusions of law or policy upon which the order
or regulation is based.
(h) Judicial review
(1) Petition
In a case of actual controversy as to the validity of any regulation issued under subsection (e)(1)(C) of this section, or any
order issued under subsection (f)(1)(C) or (g)(2)(C) of this section, or any regulation that is the subject of such an order, any
person who will be adversely affected by such order or regulation may obtain judicial review by filing in the United States
Court of Appeals for the circuit wherein that person resides or has its principal place of business, or in the United States
Court of Appeals for the District of Columbia Circuit, within 60 days after publication of such order or regulation, a petition
praying that the order or regulation be set aside in whole or in part.
(2) Record and jurisdiction
A copy of the petition under paragraph (1) shall be forthwith transmitted by the clerk of the court to the Administrator, or any
officer designated by the Administrator for that purpose, and thereupon the Administrator shall file in the court the record of
the proceedings on which the Administrator based the order or regulation, as provided in section 2112 of Title 28. Upon the
filing of such a petition, the court shall have exclusive jurisdiction to affirm or set aside the order or regulation complained of
in whole or in part. As to orders issued following a public evidentiary hearing, the findings of the Administrator with respect
to questions of fact shall be sustained only if supported by substantial evidence when considered on the record as a whole.
(3) Additional evidence
If a party applies to the court for leave to adduce additional evidence and shows to the satisfaction of the court that the
additional evidence is material and that there were reasonable grounds for the failure to adduce the evidence in the proceeding
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before the Administrator, the court may order that the additional evidence (and evidence in rebuttal thereof) shall be taken
before the Administrator in the manner and upon the terms and conditions the court deems proper. The Administrator may
modify prior findings as to the facts by reason of the additional evidence so taken and may modify the order or regulation
accordingly. The Administrator shall file with the court any such modified finding, order, or regulation.
(4) Final judgment; Supreme Court review
The judgment of the court affirming or setting aside, in whole or in part, any regulation or any order and any regulation
which is the subject of such an order shall be final, subject to review by the Supreme Court of the United States as provided
in section 1254 of Title 28. The commencement of proceedings under this subsection shall not, unless specifically ordered
by the court to the contrary, operate as a stay of a regulation or order.
(5) Application
Any issue as to which review is or was obtainable under this subsection shall not be the subject of judicial review under
any other provision of law.
(i) Confidentiality and use of data
(1) General rule
Data and information that are or have been submitted to the Administrator under this section or section 348 of this title in
support of a tolerance or an exemption from a tolerance shall be entitled to confidential treatment for reasons of business
confidentiality and to exclusive use and data compensation to the same extent provided by sections 3 and 10 of the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. 136a and 136h].
(2) Exceptions
(A) In general
Data and information that are entitled to confidential treatment under paragraph (1) may be disclosed, under such security
requirements as the Administrator may provide by regulation, to--
(i) employees of the United States authorized by the Administrator to examine such data and information in the carrying
out of their official duties under this chapter or other Federal statutes intended to protect the public health; or
(ii) contractors with the United States authorized by the Administrator to examine such data and information in the
carrying out of contracts under this chapter or such statutes.
(B) Congress
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This subsection does not authorize the withholding of data or information from either House of Congress or from, to
the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of
Congress or any subcommittee of such joint committee.
(3) Summaries
Notwithstanding any provision of this subsection or other law, the Administrator may publish the informative summary
required by subsection (d)(2)(A)(i) of this section and may, in issuing a proposed or final regulation or order under this
section, publish an informative summary of the data relating to the regulation or order.
(j) Status of previously issued regulations
(1) Regulations under section 346
Regulations affecting pesticide chemical residues in or on raw agricultural commodities promulgated, in accordance with
section 371(e) of this title, under the authority of section 346(a) of this title upon the basis of public hearings instituted before
January 1, 1953, shall be deemed to be regulations issued under this section and shall be subject to modification or revocation
under subsections (d) and (e) of this section, and shall be subject to review under subsection (q) of this section.
(2) Regulations under section 348
Regulations that established tolerances for substances that are pesticide chemical residues in or on processed food, or that
otherwise stated the conditions under which such pesticide chemicals could be safely used, and that were issued under section
348 of this title on or before August 3, 1996, shall be deemed to be regulations issued under this section and shall be subject
to modification or revocation under subsection (d) or (e) of this section, and shall be subject to review under subsection (q)
of this section.
(3) Regulations under section 346a
Regulations that established tolerances or exemptions under this section that were issued on or before August 3, 1996, shall
remain in effect unless modified or revoked under subsection (d) or (e) of this section, and shall be subject to review under
subsection (q) of this section.
(4) Certain substances
With respect to a substance that is not included in the definition of the term pesticide chemical under section 321(q)(1) of
this title but was so included on the day before October 30, 1998, the following applies as of October 30, 1998:
(A) Notwithstanding paragraph (2), any regulation applying to the use of the substance that was in effect on the day
before October 30, 1998, and was on such day deemed in such paragraph to have been issued under this section, shall be
considered to have been issued under section 348 of this title.
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(B) Notwithstanding paragraph (3), any regulation applying to the use of the substance that was in effect on such day and
was issued under this section (including any such regulation issued before August 3, 1996) is deemed to have been issued
under section 348 of this title.
(k) Transitional provision
If, on the day before August 3, 1996, a substance that is a pesticide chemical was, with respect to a particular pesticidal use of
the substance and any resulting pesticide chemical residue in or on a particular food--
(1) regarded by the Administrator or the Secretary as generally recognized as safe for use within the meaning of the provisions
of subsection (a) of this section or section 321(s) of this title as then in effect; or
(2) regarded by the Secretary as a substance described by section 321(s)(4) of this title;
such a pesticide chemical residue shall be regarded as exempt from the requirement for a tolerance, as of August 3, 1996.
The Administrator shall by regulation indicate which substances are described by this subsection. Any exemption under this
subsection may be modified or revoked as if it had been issued under subsection (c) of this section.
(l) Harmonization with action under other laws
(1) Coordination with FIFRA
To the extent practicable and consistent with the review deadlines in subsection (q) of this section, in issuing a final rule
under this subsection that suspends or revokes a tolerance or exemption for a pesticide chemical residue in or on food, the
Administrator shall coordinate such action with any related necessary action under the Federal Insecticide, Fungicide, and
Rodenticide Act.
(2) Revocation of tolerance or exemption following cancellation of associated registrations
If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. 136 et seq.], cancels
the registration of each pesticide that contains a particular pesticide chemical and that is labeled for use on a particular food, or
requires that the registration of each such pesticide be modified to prohibit its use in connection with the production, storage,
or transportation of such food, due in whole or in part to dietary risks to humans posed by residues of that pesticide chemical
on that food, the Administrator shall revoke any tolerance or exemption that allows the presence of the pesticide chemical, or
any pesticide chemical residue that results from its use, in or on that food. Subsection (e) of this section shall apply to actions
taken under this paragraph. A revocation under this paragraph shall become effective not later than 180 days after--
(A) the date by which each such cancellation of a registration has become effective; or
(B) the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever
is later.
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(3) Suspension of tolerance or exemption following suspension of associated registrations
(A) Suspension
If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide Act, suspends the use of each
registered pesticide that contains a particular pesticide chemical and that is labeled for use on a particular food, due in
whole or in part to dietary risks to humans posed by residues of that pesticide chemical on that food, the Administrator
shall suspend any tolerance or exemption that allows the presence of the pesticide chemical, or any pesticide chemical
residue that results from its use, in or on that food. Subsection (e) of this section shall apply to actions taken under this
paragraph. A suspension under this paragraph shall become effective not later than 60 days after the date by which each
such suspension of use has become effective.
(B) Effect of suspension
The suspension of a tolerance or exemption under subparagraph (A) shall be effective as long as the use of each associated
registration of a pesticide is suspended under the Federal Insecticide, Fungicide, and Rodenticide Act. While a suspension
of a tolerance or exemption is effective the tolerance or exemption shall not be considered to be in effect. If the suspension
of use of the pesticide under that Act is terminated, leaving the registration of the pesticide for such use in effect under
that Act, the Administrator shall rescind any associated suspension of tolerance or exemption.
(4) Tolerances for unavoidable residues
In connection with action taken under paragraph (2) or (3), or with respect to pesticides whose registrations were suspended
or canceled prior to August 3, 1996, under the Federal Insecticide, Fungicide, and Rodenticide Act, if the Administrator
determines that a residue of the canceled or suspended pesticide chemical will unavoidably persist in the environment
and thereby be present in or on a food, the Administrator may establish a tolerance for the pesticide chemical residue. In
establishing such a tolerance, the Administrator shall take into account both the factors set forth in subsection (b)(2) of this
section and the unavoidability of the residue. Subsection (e) of this section shall apply to the establishment of such tolerance.
The Administrator shall review any such tolerance periodically and modify it as necessary so that it allows no greater level
of the pesticide chemical residue than is unavoidable.
(5) Pesticide residues resulting from lawful application of pesticide
Notwithstanding any other provision of this chapter, if a tolerance or exemption for a pesticide chemical residue in or on a food
has been revoked, suspended, or modified under this section, an article of that food shall not be deemed unsafe solely because
of the presence of such pesticide chemical residue in or on such food if it is shown to the satisfaction of the Secretary that--
(A) the residue is present as the result of an application or use of a pesticide at a time and in a manner that was lawful
under the Federal Insecticide, Fungicide, and Rodenticide Act; and
(B) the residue does not exceed a level that was authorized at the time of that application or use to be present on the food
under a tolerance, exemption, food additive regulation, or other sanction then in effect under this chapter;
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unless, in the case of any tolerance or exemption revoked, suspended, or modified under this subsection or subsection (d)
or (e) of this section, the Administrator has issued a determination that consumption of the legally treated food during the
period of its likely availability in commerce will pose an unreasonable dietary risk.
(6) Tolerance for use of pesticides under an emergency exemption
If the Administrator grants an exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136p) for a pesticide chemical, the Administrator shall establish a tolerance or exemption from the requirement for
a tolerance for the pesticide chemical residue. Such a tolerance or exemption from a tolerance shall have an expiration date.
The Administrator may establish such a tolerance or exemption without providing notice or a period for comment on the
tolerance or exemption. The Administrator shall promulgate regulations within 365 days after August 3, 1996, governing
the establishment of tolerances and exemptions under this paragraph. Such regulations shall be consistent with the safety
standard under subsections (b)(2) and (c)(2) of this section and with section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act.
(m) Fees
(1) Amount
The Administrator shall by regulation require the payment of such fees as will in the aggregate, in the judgment of the
Administrator, be sufficient over a reasonable term to provide, equip, and maintain an adequate service for the performance
of the Administrator's functions under this section. Under the regulations, the performance of the Administrator's services
or other functions under this section, including--
(A) the acceptance for filing of a petition submitted under subsection (d) of this section;
(B) establishing, modifying, leaving in effect, or revoking a tolerance or establishing, modifying, leaving in effect, or
revoking an exemption from the requirement for a tolerance under this section;
(C) the acceptance for filing of objections under subsection (g) of this section; or
(D) the certification and filing in court of a transcript of the proceedings and the record under subsection (h) of this section;
may be conditioned upon the payment of such fees. The regulations may further provide for waiver or refund of fees in
whole or in part when in the judgment of the Administrator such a waiver or refund is equitable and not contrary to the
purposes of this subsection.
(2) Deposit
All fees collected under paragraph (1) shall be deposited in the Reregistration and Expedited Processing Fund created by
section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. 136a-1(k)]. Such fees shall be available
to the Administrator, without fiscal year limitation, for the performance of the Administrator's services or functions as
specified in paragraph (1).
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(3) Prohibition
During the period beginning on the effective date of the Pesticide Registration Improvement Renewal Act and ending on
September 30, 2017, the Administrator shall not collect any tolerance fees under paragraph (1).
(n) National uniformity of tolerances
(1) Qualifying pesticide chemical residue defined
For purposes of this subsection, the term qualifying pesticide chemical residue means a pesticide chemical residue resulting
from the use, in production, processing, or storage of a food, of a pesticide chemical that is an active ingredient and that--
(A) was first approved for such use in a registration of a pesticide issued under section 3(c)(5) of the Federal Insecticide,
Fungicide, and Rodenticide Act [7 U.S.C.A. 1365(c)(5)] on or after April 25, 1985, on the basis of data determined by the
Administrator to meet all applicable requirements for data prescribed by regulations in effect under that Act [7 U.S.C.A.
136 et seq.] on April 25, 1985; or
(B) was approved for such use in a reregistration eligibility determination issued under section 4(g) of that Act [7 U.S.C.A.
136a-1(g)] on or after August 3, 1996.
(2) Qualifying Federal determination
For purposes of this subsection, the term qualifying Federal determination means a tolerance or exemption from the
requirement for a tolerance for a qualifying pesticide chemical residue that--
(A) is issued under this section after August 3, 1996, and determined by the Administrator to meet the standard under
subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an exemption) of this section; or
(B)(i) pursuant to subsection (j) of this section is remaining in effect or is deemed to have been issued under this section,
or is regarded under subsection (k) of this section as exempt from the requirement for a tolerance; and
(ii) is determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance) or (c)
(2) (in the case of an exemption) of this section.
(3) Limitation
The Administrator may make the determination described in paragraph (2)(B)(ii) only by issuing a rule in accordance with
the procedure set forth in subsection (d) or (e) of this section and only if the Administrator issues a proposed rule and allows
a period of not less than 30 days for comment on the proposed rule. Any such rule shall be reviewable in accordance with
subsections (g) and (h) of this section.
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(4) State authority
Except as provided in paragraphs (5), (6), and (8) no State or political subdivision may establish or enforce any regulatory
limit on a qualifying pesticide chemical residue in or on any food if a qualifying Federal determination applies to the presence
of such pesticide chemical residue in or on such food, unless such State regulatory limit is identical to such qualifying
Federal determination. A State or political subdivision shall be deemed to establish or enforce a regulatory limit on a pesticide
chemical residue in or on a food if it purports to prohibit or penalize the production, processing, shipping, or other handling
of a food because it contains a pesticide residue (in excess of a prescribed limit).
(5) Petition procedure
(A) In general
Any State may petition the Administrator for authorization to establish in such State a regulatory limit on a qualifying
pesticide chemical residue in or on any food that is not identical to the qualifying Federal determination applicable to such
qualifying pesticide chemical residue.
(B) Petition requirements
Any petition under subparagraph (A) shall--
(i) satisfy any requirements prescribed, by rule, by the Administrator; and
(ii) be supported by scientific data about the pesticide chemical residue that is the subject of the petition or about
chemically related pesticide chemical residues, data on the consumption within such State of food bearing the pesticide
chemical residue, and data on exposure of humans within such State to the pesticide chemical residue.
(C) Authorization
The Administrator may, by order, grant the authorization described in subparagraph (A) if the Administrator determines
that the proposed State regulatory limit--
(i) is justified by compelling local conditions; and
(ii) would not cause any food to be a violation of Federal law.
(D) Treatment
In lieu of any action authorized under subparagraph (C), the Administrator may treat a petition under this paragraph as
a petition under subsection (d) of this section to modify or revoke a tolerance or an exemption. If the Administrator
determines to treat a petition under this paragraph as a petition under subsection (d) of this section, the Administrator shall
thereafter act on the petition pursuant to subsection (d) of this section.
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(E) Review
Any order of the Administrator granting or denying the authorization described in subparagraph (A) shall be subject to
review in the manner described in subsections (g) and (h) of this section.
(6) Urgent petition procedure
Any State petition to the Administrator pursuant to paragraph (5) that demonstrates that consumption of a food containing
such pesticide residue level during the period of the food's likely availability in the State will pose a significant public health
threat from acute exposure shall be considered an urgent petition. If an order by the Administrator to grant or deny the
requested authorization in an urgent petition is not made within 30 days of receipt of the petition, the petitioning State may
establish and enforce a temporary regulatory limit on a qualifying pesticide chemical residue in or on the food. The temporary
regulatory limit shall be validated or terminated by the Administrator's final order on the petition.
(7) Residues from lawful application
No State or political subdivision may enforce any regulatory limit on the level of a pesticide chemical residue that may appear
in or on any food if, at the time of the application of the pesticide that resulted in such residue, the sale of such food with such
residue level was lawful under this section and under the law of such State, unless the State demonstrates that consumption
of the food containing such pesticide residue level during the period of the food's likely availability in the State will pose an
unreasonable dietary risk to the health of persons within such State.
(8) Savings
Nothing in this chapter preempts the authority of any State or political subdivision to require that a food containing a pesticide
chemical residue bear or be the subject of a warning or other statement relating to the presence of the pesticide chemical
residue in or on such food.
(o) Consumer right to know
Not later than 2 years after August 3, 1996, and annually thereafter, the Administrator shall, in consultation with the Secretary of
Agriculture and the Secretary of Health and Human Services, publish in a format understandable to a lay person, and distribute
to large retail grocers for public display (in a manner determined by the grocer), the following information, at a minimum:
(1) A discussion of the risks and benefits of pesticide chemical residues in or on food purchased by consumers.
(2) A listing of actions taken under subparagraph (B) of subsection (b)(2) of this section that may result in pesticide chemical
residues in or on food that present a yearly or lifetime risk above the risk allowed under subparagraph (A) of such subsection,
and the food on which the pesticide chemicals producing the residues are used.
(3) Recommendations to consumers for reducing dietary exposure to pesticide chemical residues in a manner consistent with
maintaining a healthy diet, including a list of food that may reasonably substitute for food listed under paragraph (2).
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Nothing in this subsection shall prevent retail grocers from providing additional information.
(p) Estrogenic substances screening program
(1) Development
Not later than 2 years after August 3, 1996, the Administrator shall in consultation with the Secretary of Health and Human
Services develop a screening program, using appropriate validated test systems and other scientifically relevant information,
to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect as the Administrator may designate.
(2) Implementation
Not later than 3 years after August 3, 1996, after obtaining public comment and review of the screening program described
in paragraph (1) by the scientific advisory panel established under section 25(d) of the Federal Insecticide, Fungicide,
and Rodenticide Act [7 U.S.C.A. 136w(d)] or the science advisory board established by section 4365 of Title 42, the
Administrator shall implement the program.
(3) Substances
In carrying out the screening program described in paragraph (1), the Administrator--
(A) shall provide for the testing of all pesticide chemicals; and
(B) may provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide
chemical if the Administrator determines that a substantial population may be exposed to such substance.
(4) Exemption
Notwithstanding paragraph (3), the Administrator may, by order, exempt from the requirements of this section a biologic
substance or other substance if the Administrator determines that the substance is anticipated not to produce any effect in
humans similar to an effect produced by a naturally occurring estrogen.
(5) Collection of information
(A) In general
The Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, or
to a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testing
in accordance with the screening program described in paragraph (1), and submit information obtained from the testing
to the Administrator, within a reasonable time period that the Administrator determines is sufficient for the generation
of the information.
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(B) Procedures
To the extent practicable the Administrator shall minimize duplicative testing of the same substance for the same endocrine
effect, develop, as appropriate, procedures for fair and equitable sharing of test costs, and develop, as necessary, procedures
for handling of confidential business information.
(C) Failure of registrants to submit information
(i) Suspension
If a registrant of a substance referred to in paragraph (3)(A) fails to comply with an order under subparagraph (A) of
this paragraph, the Administrator shall issue a notice of intent to suspend the sale or distribution of the substance by the
registrant. Any suspension proposed under this paragraph shall become final at the end of the 30-day period beginning
on the date that the registrant receives the notice of intent to suspend, unless during that period a person adversely
affected by the notice requests a hearing or the Administrator determines that the registrant has complied fully with
this paragraph.
(ii) Hearing
If a person requests a hearing under clause (i), the hearing shall be conducted in accordance with section 554 of Title
5. The only matter for resolution at the hearing shall be whether the registrant has failed to comply with an order under
subparagraph (A) of this paragraph. A decision by the Administrator after completion of a hearing shall be considered
to be a final agency action.
(iii) Termination of suspensions
The Administrator shall terminate a suspension under this subparagraph issued with respect to a registrant if the
Administrator determines that the registrant has complied fully with this paragraph.
(D) Noncompliance by other persons
Any person (other than a registrant) who fails to comply with an order under subparagraph (A) shall be liable for the same
penalties and sanctions as are provided under section 16 of the Toxic Substances Control Act [15 U.S.C.A. 2615] in
the case of a violation referred to in that section. Such penalties and sanctions shall be assessed and imposed in the same
manner as provided in such section 16.
(6) Agency action
In the case of any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on
humans, the Administrator shall, as appropriate, take action under such statutory authority as is available to the Administrator,
including consideration under other sections of this chapter, as is necessary to ensure the protection of public health.
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(7) Report to Congress
Not later than 4 years after August 3, 1996, the Administrator shall prepare and submit to Congress a report containing--
(A) the findings of the Administrator resulting from the screening program described in paragraph (1);
(B) recommendations for further testing needed to evaluate the impact on human health of the substances tested under
the screening program; and
(C) recommendations for any further actions (including any action described in paragraph (6)) that the Administrator
determines are appropriate based on the findings.
(q) Schedule for review
(1) In general
The Administrator shall review tolerances and exemptions for pesticide chemical residues in effect on the day before August
3, 1996, as expeditiously as practicable, assuring that--
(A) 33 percent of such tolerances and exemptions are reviewed within 3 years of August 3, 1996;
(B) 66 percent of such tolerances and exemptions are reviewed within 6 years of August 3, 1996; and
(C) 100 percent of such tolerances and exemptions are reviewed within 10 years of August 3, 1996.
In conducting a review of a tolerance or exemption, the Administrator shall determine whether the tolerance or exemption
meets the requirements of subsections
1
(b)(2) or (c)(2) of this section and shall, by the deadline for the review of the
tolerance or exemption, issue a regulation under subsection (d)(4) or (e)(1) of this section to modify or revoke the tolerance
or exemption if the tolerance or exemption does not meet such requirements.
(2) Priorities
In determining priorities for reviewing tolerances and exemptions under paragraph (1), the Administrator shall give priority
to the review of the tolerances or exemptions that appear to pose the greatest risk to public health.
(3) Publication of schedule
Not later than 12 months after August 3, 1996, the Administrator shall publish a schedule for review of tolerances and
exemptions established prior to August 3, 1996. The determination of priorities for the review of tolerances and exemptions
pursuant to this subsection is not a rulemaking and shall not be subject to judicial review, except that failure to take final
action pursuant to the schedule established by this paragraph shall be subject to judicial review.
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(r) Temporary tolerance or exemption
The Administrator may, upon the request of any person who has obtained an experimental permit for a pesticide chemical under
the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. 136 et seq.] or upon the Administrator's own initiative,
establish a temporary tolerance or exemption for the pesticide chemical residue for the uses covered by the permit. Subsections
(b)(2), (c)(2), (d), and (e) of this section shall apply to actions taken under this subsection.
(s) Savings clause
Nothing in this section shall be construed to amend or modify the provisions of the Toxic Substances Control Act [15 U.S.C.A.
2601 et seq.] or the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. 136 et seq.].
Credits
(June 25, 1938, c. 675, 408, as added July 22, 1954, c. 559, 3, 68 Stat. 511; amended Aug. 28, 1958, Pub.L. 85-791, 20, 72
Stat. 947; Oct. 30, 1970, Pub.L. 91-515, Title VI, 601(d)(1), 84 Stat. 1311; 1970 Reorg. Plan No. 3, 2(a)(4), (8)(ii), eff. Dec.
2, 1970, 35 F.R. 15623, 84 Stat. 2086; Nov. 18, 1971, Pub.L. 92-157, Title III, 303(a), 85 Stat. 464; Oct. 21, 1972, Pub.L.
92-516, 3(3), 86 Stat. 998; Nov. 8, 1984, Pub.L. 98-620, Title IV, 402(25)(A), 98 Stat. 3359; June 16, 1992, Pub.L. 102-300,
6(b)(1), 106 Stat. 240; Oct. 29, 1992, Pub.L. 102-571, Title I, 107(7), 106 Stat. 4499; Aug. 13, 1993, Pub.L. 103-80, 3(k),
107 Stat. 776; Aug. 3, 1996, Pub.L. 104-170, Title IV, 405, 110 Stat. 1514; Oct. 30, 1998, Pub.L. 105-324, 2(b), 112 Stat.
3036; Oct. 9, 2007, Pub.L. 110-94, 4(d)(2), 121 Stat. 1002; Pub.L. 112-177, 2(a)(3), Sept. 28, 2012, 126 Stat. 1329.)
Notes of Decisions (30)
Footnotes
1 So in original. Probably should be subsection.
21 U.S.C.A. 346a, 21 USCA 346a
Current through P.L. 112-197 approved 11-27-12
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P 1oq-q, AugusL z, zoo, 11q SLuL qqq
UNITED STATES PUBLIC LAWS
109th Congress - First Session
Convening January 7, 2005
Additions and Deletions are not identified in this database.
Vetoed provisions within tabular material are not displayed
PL 10954 (HR 2361)
August 2, 2005
DEPARTMENT OF THE INTERIOR, ENVIRONMENT, AND RELATED AGENCIES APPROPRIATIONS ACT, 2006
An Act Making appropriations for the Department of the Interior, environment, and related agencies for the fiscal year ending
September 30,2006, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That the
following sums are appropriated, out of any money in the Treasury not otherwise appropriated, for the Department of the
Interior, environment, and related agencies for the fiscal year ending September 30, 2006, and for other purposes, namely:
TITLE IDEPARTMENT OF THE INTERIOR
Bureau of Land Management
MANAGEMENT OF LANDS AND RESOURCES
For necessary expenses for protection, use, improvement, development, disposal, cadastral surveying, classification,
acquisition of easements and other interests in lands, and performance of other functions, including maintenance of facilities,
as authorized by law, in the management of lands and their resources under the jurisdiction of the Bureau of Land Management,
including the general administration of the Bureau, and assessment of mineral potential of public lands pursuant to Public
Law 96487 (16 U.S.C. 3150(a)), $860,791,000, to remain available until expended, of which $1,250,000 is for high priority
projects, to be carried out by the Youth Conservation Corps; and of which $3,000,000 shall be available in fiscal year 2006
subject to a match by at least an equal amount by the National Fish and Wildlife Foundation for cost-shared projects supporting
conservation of Bureau lands; and such funds shall be advanced to the Foundation as a lump sum grant without regard to when
expenses are incurred.
In addition, $32,696,000 is for Mining Law Administration program operations, including the cost of administering the mining
claim fee program; to remain available until expended, to be reduced by amounts collected by the Bureau and credited to this
appropriation from annual mining claim fees so as to result in a final appropriation estimated at not more than $860,791,000,
and $2,000,000, to remain available until expended, from communication site rental fees established by the Bureau for the cost
of administering communication site activities.
WILDLAND FIRE MANAGEMENT
(INCLUDING TRANSFER OF FUNDS)
For necessary expenses for fire preparedness, suppression operations, fire science and research, emergency rehabilitation,
hazardous fuels reduction, and rural fire assistance by the Department of the Interior, $766,564,000, to remain available until
expended, of which not to exceed $7,849,000 shall be for the renovation or construction of fire facilities: Provided, That such
funds are also available for repayment of advances to other appropriation accounts from which funds were previously transferred
for such purposes: Provided further, That persons hired pursuant to 43 U.S.C. 1469 may be furnished subsistence and lodging
without cost from funds available from this appropriation: Provided further, That notwithstanding 42 U.S.C. 1856d, sums
received by a bureau or office of the Department of the Interior for fire protection rendered pursuant to 42 U.S.C. 1856 et
seq., protection of United States property, may be credited to the appropriation from which funds were expended to provide
that protection, and are available without fiscal year limitation: Provided further, That using the amounts designated under
this title of this Act, the Secretary of the Interior may enter into procurement contracts, grants, or cooperative agreements,
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Beginning in fiscal year 2006 and thereafter, and notwithstanding section 306 of the Toxic Substances Control Act, the Federal
share of the cost of radon program activities implemented with Federal assistance under section 306 shall not exceed 60 percent
in the third and subsequent grant years.
General Provisions, Environmental Protection Agency
SEC. 201. None of the funds made available by this Act may be used by the Administrator of the Environmental Protection
Agency to accept, consider or rely on third-party intentional dosing human toxicity studies for pesticides, or to conduct
intentional dosing human toxicity studies for pesticides until the Administrator issues a final rulemaking on this subject. The
Administrator shall allow for a period of not less than 90 days for public comment on the Agency's proposed rule before issuing
a final rule. Such rule shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with the
principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles
of the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects Review
Board. The final rule shall be issued no later than 180days after enactment of this Act.
SEC. 202. None of the funds made available by this Act may be used in contravention of, or to delay the implementation
of, Executive Order No. 12898 of February 11, 1994 (59 Fed. Reg. 7629; relating to Federal actions to address environmental
justice in minority populations and low-income populations).
SEC. 203. None of the funds made available in this Act may be used to finalize, issue, implement, or enforce the proposed
policy of the Environmental Protection Agency entitled National Pollutant Discharge Elimination System (NPDES) Permit
Requirements for Municipal Wastewater Treatment During Wet Weather Conditions, dated November 3, 2003 (68 Fed. Reg.
63042).
SEC. 204. None of the funds made available in this Act may be used in contravention of 15 U.S.C. 2682(c)(3) or to delay
the implementation of that section.
SEC. 205. None of the funds provided in this Act or any other Act may be used by the Environmental Protection Agency
(EPA) to publish proposed or final regulations pursuant to the requirements of section 428(b) of division G of Public Law 108
199 until the Administrator of the Environmental Protection Agency, in coordination with other appropriate Federal agencies,
has completed and published a technical study to look at safety issues, including the risk of fire and burn to consumers in
use, associated with compliance with the regulations. Not later than 6 months after the date of enactment of this Act, the
Administrator shall complete and publish the technical study.
TITLE IIIRELATED AGENCIES
DEPARTMENT OF AGRICULTURE
Forest Service
FOREST AND RANGELAND RESEARCH
For necessary expenses of forest and rangeland research as authorized by law, $283,094,000, to remain available until
expended: Provided, That of the funds provided, $60,267,000 is for the forest inventory and analysis program.
STATE AND PRIVATE FORESTRY
For necessary expenses of cooperating with and providing technical and financial assistance to States, territories, possessions,
and others, and for forest health management, including treatments of pests, pathogens, and invasive or noxious plants
and for restoring and rehabilitating forests damaged by pests or invasive plants, cooperative forestry, and education and
land conservation activities and conducting an international program as authorized, $283,577,000, to remain available until
expended, as authorized by law of which $57,380,000 is to be derived from the Land and Water Conservation Fund: Provided,
That none of the funds provided under this heading for the acquisition of lands or interests in lands shall be available until
the Forest Service notifies the House Committee on Appropriations and the Senate Committee on Appropriations, in writing,
of specific contractual and grant details including the non-Federal cost share: Provided further, That of the funds provided
herein, $1,000,000 shall be provided to Custer County, Idaho, for economic development in accordance with the Central
Idaho Economic Development and Recreation Act, subject to authorization: Provided further, That notwithstanding any other
provision of law, of the funds provided under this heading, an advance lump sum payment of $1,000,000 shall be made available
to Madison County, North Carolina, for a forest recreation center, and a similar $500,000 payment shall be made available to
Folkmoot USA in Haywood County, North Carolina, for Appalachian folk programs including forest crafts.
NATIONAL FOREST SYSTEM
(INCLUDING TRANSFERS OF FUNDS)
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Code oI ederuI ReguIuLIons
TILIe qo. ProLecLIon oI EnvIronmenL
ChuLer . EnvIronmenLuI ProLecLIon Agency (ReIs & Annos)
SubchuLer A. GeneruI
PurL z6. ProLecLIon oI Humun SubjecLs (ReIs & Annos)
SuburL Q. ELhIcuI SLundurds Ior AssessIng WheLher Lo ReIy on Lhe ResuILs oI Humun Reseurch In
EPA AcLIons (ReIs & Annos)
qo C..R. z6.1;oq
z6.1;oq ProhIbILIon oI reIIunce on uneLhIcuI humun reseurch wILh
non-regnunL, non-nursIng uduILs conducLed beIore ArII ;, zoo6.
EIIecLIve: JuIy zq, zoo6
CurrenLness
Except as provided in 26.1706, in actions within the scope of 26.1701, EPA shall not rely on data from any research initiated
before April 7, 2006, if there is clear and convincing evidence that the conduct of the research was fundamentally unethical
(e.g., the research was intended to seriously harm participants or failed to obtain informed consent), or was significantly
deficient relative to the ethical standards prevailing at the time the research was conducted. This prohibition is in addition to
the prohibition in 26.1703.
Credits
[71 FR 36175, June 23, 2006]
SOURCE: 56 FR 28012, 28022, June 18, 1991; 71 FR 6168, 6176, Feb. 6, 2006; 71 FR 6168, Feb. 6, 2006, unless otherwise
noted.
AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 10954; and 42
U.S.C. 300v1(b).
Current through December 6, 2012; 77 FR 72762
End of Document 2012 Thomson Reuters. No claim to original U.S. Government Works.
SPA-117
178.32 Rulings on requests for hearing., 40 C.F.R. 178.32
2012 Thomson Reuters. No claim to original U.S. Government Works. 1
Code oI ederuI ReguIuLIons
TILIe qo. ProLecLIon oI EnvIronmenL
ChuLer . EnvIronmenLuI ProLecLIon Agency (ReIs & Annos)
SubchuLer E. PesLIcIde Progrums
PurL 1;8. ObjecLIons und RequesLs Ior HeurIngs (ReIs & Annos)
SuburL B. Procedures Ior IIIng ObjecLIons und RequesLs Ior HeurIng
qo C..R. 1;8.z
1;8.z RuIIngs on requesLs Ior heurIng.
CurrenLness
(a) In the case of each request for an evidentiary hearing that was not denied under 178.30(a) or (b), the Administrator will
determine whether such a hearing on one or more of the objections is justified, and will publish in the Federal Register the
determination in an order issued under 178.37 or a Notice of Hearing issued under 179.20 of this chapter. If some requests
for a hearing are denied and others pertaining to the same order or regulation are granted, the denial order and the hearing
notice may be combined into a single document and shall be issued at the same time unless the Administrator for good cause
determines otherwise.
(b) A request for an evidentiary hearing will be granted if the Administrator determines that the material submitted shows the
following:
(1) There is a genuine and substantial issue of fact for resolution at a hearing. An evidentiary hearing will not be granted
on issues of policy or law.
(2) There is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or
more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary. An evidentiary
hearing will not be granted on the basis of mere allegations, denials, or general descriptions of positions and contentions,
nor if the Administrator concludes that the data and information submitted, even if accurate, would be insufficient to justify
the factual determination urged.
(3) Resolution of the factual issue(s) in the manner sought by the person requesting the hearing would be adequate to
justify the action requested. An evidentiary hearing will not be granted on factual issues that are not determinative with
respect to the action requested. For example, a hearing will not be granted if the Administrator concludes that the action
would be the same even if the factual issue were resolved in the manner sought.
(c) Where appropriate, the Administrator will make rulings on any issues raised by an objection which are necessary for
resolution prior to determining whether a request for an evidentiary hearing should be granted.
SOURCE: 55 FR 50291, Dec. 5, 1990; 70 FR 33359, June 8, 2005, unless otherwise noted.
AUTHORITY: 21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.
SPA-118
178.32 Rulings on requests for hearing., 40 C.F.R. 178.32
2012 Thomson Reuters. No claim to original U.S. Government Works. 2
Current through December 6, 2012; 77 FR 72762
End of Document 2012 Thomson Reuters. No claim to original U.S. Government Works.
SPA-119
CONGRESSIONAL RECORDHOUSE H3670 May 19, 2005
small quantities of custom glass and
ceramic ware for special occasions.
Some of Nancys work can even be
found in the House gift shop and some
is sold in the EPAs gift shop. When
they print mugs or glasses for cus-
tomers, they sometimes use lead-bear-
ing colors on the outside surface. These
colors are expensive, so they use a min-
imum amount of paint, just that which
is needed to color the surfaces and they
try to reduce waste. And the finishing
process ensures that none of the lead
leaches out. So their products are safe
for anyone who uses them.
But because of the EPAs Toxics Re-
lease Inventory lead rule, Nancys busi-
ness is forced to compile daily records
on how much color is used for the mugs
because the color contains a very small
amount of lead. Each year her small
business has to report to the EPA how
much lead has been used. It costs her
about $7,000 annually and across the
Nation about $70 million every year.
And what do the Americans get for the
millions that are spent? Cleaner air?
No. Less lead being used? No. Less ex-
posure to lead by children? No. The an-
swer is none of these. But all the Amer-
ican people get from these thousands of
reports are estimates on how much
lead is being consumed, but our air is
not any cleaner.
Mr. Chairman, with the hopes of
working during the conference com-
mittee report, I intend to withdraw
this amendment because I know it is
subject to a point of order. I hope that
we can work together with the gen-
tleman from North Carolina (Chairman
Taylor) in the conference report to try
to remove some of these unnecessary
regulations.
So, in conclusion, we must not move
forward with our government to imple-
ment regulatory burdens like this on
the American public because it drives
jobs overseas, it increases the trade
deficit, it reduces the Federal revenue,
and it moves us toward a third-rate
economy.
Mr. Chairman, I ask unanimous con-
sent to withdraw the amendment.
The Acting CHAIRMAN. Is there ob-
jection to the request of the gentleman
from Kansas?
There was no objection.
AMENDMENT NO. 9 OFFERED BY MR. POMBO
Mr. POMBO. Mr. Chairman, I offer an
amendment.
The Acting CHAIRMAN. The Clerk
will designate the amendment.
The text of the amendment is as fol-
lows:
Amendment No. 9 offered by Mr. POMBO:
At the end of the bill (before the short
title) add the following new section:
SEC. ll. The funds appropriated in this
Act under the following headings are avail-
able only to the extent provided for in au-
thorizing legislation enacted before the date
of the enactment of this Act or on or after
such date:
(1) Bureau of Land ManagementRange
Improvements.
(2) United States Fish and Wildlife Serv-
iceResource Management.
(3) United States Fish and Wildlife Serv-
iceCooperative Endangered Species Con-
servation Fund.
(4) United States Fish and Wildlife Serv-
iceNeotropical Migratory Bird Conserva-
tion.
(5) United States Fish and Wildlife Serv-
iceMultinational Species Conservation
Fund.
(6) National Park ServiceHistoric Pres-
ervation Fund.
(7) United States Geological SurveySur-
veys, Investigations, and Research.
(8) Bureau of Indian AffairsIndian Land
and Water Claim Settlements and Miscella-
neous Payments to Indians.
(9) Indian Health ServiceIndian Health
Services.
(10) Indian Health ServiceIndian Health
Facilities.
(11) Executive Office of the President
Council on Environmental Quality and Office
of Environmental Quality.
Mr. DICKS. Mr. Chairman, I reserve a
point of order against the amendment.
The Acting CHAIRMAN. Pursuant to
the order of the House of today, the
gentleman from California (Mr. POMBO)
and a Member opposed each will con-
trol 5 minutes.
The Chair recognizes the gentleman
from California (Mr. POMBO).
Mr. POMBO. Mr. Chairman, I yield
myself such time as I may consume.
Appropriations without authoriza-
tions or that exceed authorized levels
violate House rule XXI, clause 2. This
amendment enforces this rule by not
allowing moneys to be spent for 10
specified programs within the Com-
mittee on Resources sole jurisdiction
which are not authorized to be funded
in fiscal year 2006 until the Committee
on Resources authorizes them. The
money remains in the bill but cannot
be obligated by the agencies until the
authorizing committee authorizes
them to do so.
Because the Interior appropriations
bill often combines both authorized
and unauthorized programs in a single
number, such as funding for survey ac-
tivities of the U.S. Geological Survey,
the amendment assures that these pro-
grams which are authorized by fiscal
year 2006, their funding cannot con-
tinue.
For those programs which are au-
thorized but the amount appropriated
exceeds the authorized level, such as in
the case for the Council on Environ-
mental Quality, then the amendment
restricts the funding to the authorized
level.
The purpose of this amendment is to
give us the ability to go back and au-
thorize a number of these programs
that have not been authorized for years
and in some cases in excess of a dozen
years. One of the major problems that
we have is the Committee on Appro-
priations gets in the position of having
to continue to appropriate money on
these unauthorized programs because
they are important programs. But in
this case what we are talking about is
$5.3 billion that is being appropriated.
So this is a fiscal issue.
I believe that the taxpayer demands
that we do our job in authorizing these
programs and make sure that the pub-
lic is getting their moneys worth out
of these different programs. Currently,
I do not believe that is the case. And it
gives us the ability to go back and au-
thorize those programs.
I believe this is something that is ex-
tremely important. The gentleman
from North Carolina (Mr. TAYLOR) and
the gentleman from Washington (Mr.
DICKS) have worked with us on a num-
ber of different things that are in this
bill over the past year. But when it
comes to some of these major programs
that we have not been able to get an
authorization on, I believe the time is
now for us to move forward and begin
to fence off those moneys until we can
get an authorization done.
Mr. Chairman, I reserve the balance
of my time.
POINT OF ORDER
Mr. DICKS. Mr. Chairman, I raise a
point of order against the amendment.
I do it with great respect for the chair-
man, but I just worry about what the
consequences of his amendment would
be to this bill.
Therefore, Mr. Chairman, I raise a
point of order against the amendment
because it proposes to change existing
law and constitutes legislation in an
appropriation bill and therefore vio-
lates clause 2 of rule XXI.
The rule states in pertinent part:
An amendment to a general appro-
priation bill shall not be in order if
changing existing law.
The Acting CHAIRMAN (Mr.
HASTINGS of Washington). Does any
Member wish to be heard on the point
of order?
Mr. POMBO. Mr. Chairman, I realize
that the gentleman is correct when he
talks about authorizing an appropria-
tions bill and the effect that my
amendment would have. But I would
urge the Chair to rule the amendment
in order because what I am trying to do
is strip out and put fencing around ap-
propriations for unauthorized pro-
grams. It seems kind of ironic that my
amendment that goes after unauthor-
ized programs would be ruled out of
order for the very reason that I have
been going after those programs.
I urge the chairman to rule the
amendment in order.
The Acting CHAIRMAN. If no other
Member wishes to be heard, the Chair
is prepared to rule.
The Chair finds that this amendment
requires new duties. The amendment
therefore constitutes legislation in vio-
lation of clause 2 of rule XXI.
The point of order is sustained, and
the amendment is not in order.
b 1900
AMENDMENT OFFERED BY MS. SOLIS
Ms. SOLIS. Mr. Chairman, I offer an
amendment.
The Acting CHAIRMAN (Mr.
HASTINGS of Washington). The Clerk
will designate the amendment.
The text of the amendment is as fol-
lows:
Amendment offered by Ms. SOLIS:
Add at the end of the bill (preceding the
short title) the following:
SEC. 4ll. None of the funds made avail-
able in this Act may be used by the Adminis-
trator of the Environmental Protection
Agency
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SPA-120
CONGRESSIONAL RECORDHOUSE H3671 May 19, 2005
(1) to accept, consider, or rely on third-
party intentional dosing human studies for
pesticides; or
(2) to conduct intentional dosing human
studies for pesticides.
The Acting CHAIRMAN. Pursuant to
the order of the House today, the gen-
tlewoman from California (Ms. SOLIS)
and a Member opposed each will con-
trol 5 minutes.
The Chair recognizes the gentle-
woman from California (Ms. SOLIS).
Ms. SOLIS. Mr. Chairman, I yield
myself such time as I may consume.
This amendment would ensure that
the Environmental Protection Agency
could not use funds in this legislation
to accept, consider, or rely on studies
from outside parties that intentionally
expose human beings to pesticides. It
would also ensure that the EPA could
not spend any funds conducting its own
studies which intentionally expose hu-
mans to pesticides.
According to EPA Administrator
Stephen Johnson back in 2001, EPA
believes that we have a more than
sufficient database, through use of ani-
mal studies, to make licensing deci-
sions that meet the standard, to pro-
tect the health of the public, without
using human studies.
Mr. TAYLOR of North Carolina. Mr.
Chairman, will the gentlewoman yield?
Ms. SOLIS. I yield to the gentleman
from North Carolina.
Mr. TAYLOR of North Carolina. Mr.
Chairman, if we withdraw any objec-
tion to this amendment, is the gentle-
woman envisioning a rollcall vote or
just a simple voice vote?
Ms. SOLIS. Mr. Chairman, no rollcall
vote.
Mr. TAYLOR of North Carolina. Mr.
Chairman, I withdraw any objection to
this amendment.
Ms. SOLIS. Mr. Chairman, I yield
myself such time as I may consume,
and I thank the gentleman from North
Carolina.
Mr. Chairman, I will submit the re-
mainder of my statement for the
RECORD, and I would ask that Members
of the House approve this amendment.
It is long overdue. I am very grateful
to accept support from the other side
of the aisle.
Despite this statement, the EPA can
devise and conduct studies where hu-
manschildren and adultsare ex-
posed to pesticides.
Current practices also allow the EPA
to accept studies from the pesticide in-
dustry and other outside sources so
these studies can be used to help de-
velop regulations or approve pesticides.
Right now, the United States Envi-
ronmental Protection Agencythe
agency in charge of protecting public
health from environmental toxinsis
encouraging industry to use human
beings as guinea pigs.
What may be the greatest offense
yet, is that the EPA is conducting and
engaging in these studies with no bind-
ing safeguards to make sure these tests
protect public health.
The EPA has chosen to go against
the recommendation of the National
Academy of Sciences and against the
wishes of its own Science Advisory
Board and Science Advisory panel.
Not only are there no binding safe-
guards for EPA conducted studies, but
many of the outside studies which the
EPA accepts fail to meet minimum
international standards established in
the Nuremberg Code and in the Hel-
sinki Declaration of the World Medical
Association.
This behavior is deplorable, uneth-
ical, and wrong.
Our amendment is critical because,
in the absence of binding standards at
EPA, the pesticides industry has in-
creased its use of human testing stud-
ies and putting more humans at risk
for what are frequently statistically in-
valid studies.
The trend of using humansboth
children and adultsas guinea pigs is a
trend that needs to stop.
The EPA needs to have binding safe-
guards in place, and we need to have
information about how a better under-
standing of how dangerous and toxic
these pesticides are for our children.
Without these safeguards the EPA
should not be conducting tests which
dangerously expose humans to pes-
ticides nor should it be developing pol-
icy based on third party studies which
fail to meet even basic internationally
accepted standards.
My colleagues, the Solis-Bishop
amendment is supported by environ-
mental and diverse religious organiza-
tions and among more than 80,000 oth-
ers who have written to me saying they
oppose the CHEERS study and support
a moratorium on this type of testing.
I urge you to support our amendment
and prevent the unregulated and un-
ethical testing of pesticides on hu-
mans.
Mr. Chairman, I yield 2 minutes to
the gentleman from New York (Mr.
BISHOP), the cosponsor of this amend-
ment.
Mr. BISHOP of New York. Mr. Chair-
man, I want to thank the gentlewoman
from California for her leadership on
this issue and for yielding me this
time, and I want to thank the chair-
man for accepting our amendment.
I have a statement that I will submit
for the RECORD.
Mr. Chairman, I thank the gentle-
woman from California (Ms. SOLIS), for
yielding and introducing this amend-
ment, which Im proud to cosponsor.
Mr. Chairman, how do you make a
bad idea worse? If youre EPA, offer
families $970 to videotape their chil-
dren reacting to bug sprays, carpet
cleaners, and other household pes-
ticides.
Then, invite the American Chemistry
Council as a partner in this study,
knowing that in exchange for $2 mil-
lion paid toward the study, it wants
looser regulations for the pesticide in-
dustry, which in turn wants to use hu-
mans instead of animals so it can jus-
tify relaxed exposure limits.
EPAs study is as poorly conceived as
its acronym: CHEERSwhich stands
for the Childrens Health Environ-
mental Exposure Research Study. Its a
trifecta of unethical, immoral, and un-
scientific research.
It violates the post World War II
Nuremburg Code, which outlawed
medical testing, including pesticide
testing on people.
It advances private rather than med-
ical interests, putting industry ahead
of public health.
And despite EPAs own Science Advi-
sory Board and Scientific Advisory
Panels recommendening strict safe-
guards for human testing, EPA failed
to adopt them.
Mr. Chairman, we all want to under-
stand how common chemicals like
those found under the kitchen sink can
hurt children, the elderly and the most
vulnerable to poisoning. But the way
to collect that information should not
involve hurting the very people we
want to protect.
The government should not be asking
families to turn their babies into lab
rats. We should be protecting children,
not exposing them to pesticides.
Although we passed this amendment
by unanimous consent two years ago,
EPA resurrected the study when the
fiscal year expired in October.
We need to pass the Solis-Bishop
amendment to ensure EPAs research
is based on sound science with the
highest ethical standards.
Our amendment is supported by a
broad coalition of environmental advo-
cates, including the Alliance for
Human Research Protection in my
home state of New York.
I strongly encourage my colleagues
to support this amendment, again
thank the gentlewoman from Cali-
fornia for her excellent work.
Ms. SOLIS. Mr. Chairman, I yield
back the balance of my time.
The Acting CHAIRMAN. The ques-
tion is on the amendment offered by
the gentlewoman from California (Ms.
SOLIS).
The amendment was agreed to.
AMENDMENT NO. 3 OFFERED BY MR. GARRETT OF
NEW JERSEY
Mr. GARRETT of New Jersey. Mr.
Chairman, I offer an amendment.
The Acting CHAIRMAN. The Clerk
will designate the amendment.
The text of the amendment is as fol-
lows:
Amendment No. 3 offered by Mr. GARRETT
of New Jersey:
At the end of the bill (before the short
title), insert the following:
SEC. ll. None of the funds made available
in this Act may be used to send or otherwise
pay for the attendance of more than 50 Fed-
eral employees at any single conference oc-
curring outside the United States.
The Acting CHAIRMAN. Pursuant to
the order of the House today, the gen-
tleman from New Jersey (Mr. GARRETT)
and a Member opposed each will con-
trol 5 minutes.
The CHAIR recognizes the gentleman
from New Jersey (Mr. GARRETT).
Mr. GARRETT of New Jersey. Mr.
Chairman, I yield myself such time as
I may consume.
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SPA-121
CONGRESSIONAL RECORDHOUSE H6941 July 28, 2005
RECOGNIZING STEVE SAULS
(Ms. ROS-LEHTINEN asked and was
given permission to address the House
for 1 minute and to revise and extend
her remarks.)
Ms. ROS-LEHTINEN. Mr. Speaker, I
rise today to recognize Steve Sauls, an
extraordinary advocate for the stu-
dents and the school of Florida Inter-
national University in my hometown of
Miami.
As an experienced member of the ad-
ministration and leadership at the uni-
versity, Steve has worked incredibly
hard to promote the needs and the in-
terests necessary to make FIU the fine
institution that it is today.
Steve is retiring from his current po-
sition as vice president of government
affairs for the university after 14 won-
derful and productive years and has ac-
cepted a job as vice president of cor-
porate relations in a private sector
firm. I know that Steve will be im-
mensely missed at the university, my
alma mater, and will leave a void that
will be difficult to fill. I have no doubt
that Steve will continue to lead and
excel in his new position, and I wish
him all the best and FIU all the best in
the years to come.
f
b 1015
SOCIAL SECURITY CELEBRATES
ITS 70TH ANNIVERSARY
(Mr. PALLONE asked and was given
permission to address the House for 1
minute.)
Mr. PALLONE. Mr. Speaker, on Au-
gust 14, we will be celebrating the 70th
anniversary of Social Security, and
that is 70 years of a guaranteed, prom-
ised benefit to all Americans of a cer-
tain age.
I have to say, I was interested to note
that I looked on the Social Security
Administration Web site, and I did not
see any mention of the 70th anniver-
sary. I think the reason is clear. This
President, who basically is trying to
dismantle Social Security, does not
want the Social Security Administra-
tion to celebrate this landmark
achievement.
Now, the President and House Repub-
licans want Americans to forget how
important Social Security has been for
seniors and for the disabled for the last
70 years. It is a guaranteed benefit the
Republicans want to turn into a risky
privatization plan.
I know that the President continues
to be on the road pushing his risky pri-
vatization plan. Most recently he was
there with his mom, Mrs. Bush. And we
are hearing that when we come back
after the August break, we are going to
see the Republican leadership in the
House once again move forward with
their privatization plan that is going
to only aggravate Social Securitys in-
solvency.
Remember: 70 years of a guaranteed
benefit.
WAIVING POINTS OF ORDER
AGAINST CONFERENCE REPORT
ON H.R. 2361, DEPARTMENT OF
THE INTERIOR, ENVIRONMENT,
AND RELATED AGENCIES APPRO-
PRIATIONS ACT, 2006
Mr. BISHOP of Utah. Mr. Speaker, by
direction of the Committee on Rules, I
call up House Resolution 392 and ask
for its immediate consideration.
The Clerk read the resolution, as fol-
lows:
H. RES. 392
Resolved, That upon adoption of this reso-
lution it shall be in order to consider the
conference report to accompany the bill
(H.R. 2361) making appropriations for the De-
partment of the Interior, environment, and
related agencies for the fiscal year ending
September 30, 2006, and for other purposes.
All points of order against the conference re-
port and against its consideration are
waived. The conference report shall be con-
sidered as read.
The SPEAKER pro tempore (Mr.
SIMPSON). The gentleman from Utah
(Mr. BISHOP) is recognized for 1 hour.
Mr. BISHOP of Utah. Mr. Speaker,
for the purpose of debate only, I yield
the customary 30 minutes to the gen-
tleman from Florida (Mr. HASTINGS),
pending which I yield myself such time
as I may consume. During consider-
ation of this resolution, all time yield-
ed is for the purpose of debate only.
This resolution waives all points of
order against the conference report and
against its consideration.
Mr. Speaker, we now have before us
the first appropriations conference re-
port. The gentleman from North Caro-
lina (Chairman TAYLOR) and those who
have been working with him on the
House side, as well as on the Senate
side, should be applauded for taking
this appropriation process and concept
of prioritization and presenting the
product that we have before us. The In-
terior conferees have produced a con-
ference report which is fiscally respon-
sible and does live within strict budget
discipline. It recommends for the fiscal
year 2006 budget $26.2 billion, which is
actually below last years enacted level
of $27 billion.
Even though the total number is
lower, it still takes into account sig-
nificant and important and high-pri-
ority items, such as wildland fire-
fighting, $2.7 billion; a $61 million in-
crease for our National Parks; a $31
million increase in our National Forest
System; and $106 million increase for
the Indian Health Service. Indian pro-
grams have been represented at a
record $5.6 billion, which means the
funding will provide for schools and
hospitals, construction, education,
human service needs, as well as law en-
forcement there.
With those increases there, it has to
be significant, and there have to be off-
setting balances somewhere else, and
that is where the process of
prioritization takes place. Once again,
whether you like the total and the way
it has been done, at least this com-
mittee has indeed done that process of
prioritization.
I commend the Subcommittee chair-
man (Mr. TAYLOR); the chairman of the
full Committee on Appropriations, the
gentleman from California (Mr. LEWIS);
the ranking members who were in-
volved in this, as well as all the con-
ferees, for shepherding this measure,
this funding measure through the con-
ference process in a timely and orderly
fashion in the midst of a very lean
budget climate.
Mr. Speaker, the conference report is
obviously not perfect; none of these
ever are. We are not totally happy with
all of the aspects of it. I, for example,
still have a concern over our process
that we are doing with Payment in
Lieu of Taxes, or the PILT program.
This House was wise enough to fund
that program at $242 million; the con-
ference funds it at $6 million less, at
$236 million. That still is $30 million
above what the Senate tried to accom-
plish. This program, for example, is the
basic funding for rural communities; it
is rent that is due on the land that is
government owned. If the Federal Gov-
ernment is going to own the land, they
need to be able to fully support that.
Hope springs eternal, and we in the
West will continue to work on this pro-
gram in the future with the gentleman
from North Carolina (Chairman TAY-
LOR), the gentleman from California
(Chairman LEWIS), and others to make
sure that these programs are ade-
quately addressed in the future as well.
In closing, and notwithstanding these
concerns, Mr. Speaker, the overall con-
ference agreement is a good, bipartisan
product. It has been done in a timely
manner. It is the first one before us. It
deserves our support.
Mr. Speaker, I reserve the balance of
my time.
Mr. HASTINGS of Florida. Mr.
Speaker, I thank the gentleman from
Utah (Mr. BISHOP) for yielding me this
time, and I yield myself such time as I
may consume.
As my colleague from the majority
mentioned, the rule is typical to that
for all conference reports, and I will
not oppose it.
Mr. Speaker, I rise today not in oppo-
sition to the Interior and Environ-
mental Appropriations conference re-
port, but, rather, in disappointment
that we have not done enough. Indeed,
we live in trying times with enormous
fiscal constraints, many of which we
have brought upon ourselves. As the
chairman and ranking Democrat of the
Subcommittee on Interior, Environ-
ment, and Related Agencies will prob-
ably note today, they did the best that
they could with what they were given.
Indeed, they did, Mr. Speaker.
I commend the gentleman from
North Carolina (Chairman TAYLOR) and
the gentleman from Washington (Mr.
DICKS) for their hard and, perhaps most
important, their bipartisan work on
this legislation. I do believe that they
did the best with what the majority
gave them.
The Interior conference report in-
cludes $84 million for Everglades res-
toration in my district and throughout
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CONGRESSIONAL RECORDHOUSE H6942 July 28, 2005
south Florida. It increases funding for
the National Endowment of the Arts
and Humanities, as well as operations
at our national parks and Indian
health care.
The underlying report also includes a
provision that I offered during floor
consideration prohibiting funds in the
bill from being used to work in con-
travention of a 1994 executive order re-
quiring that Federal agencies take the
necessary steps to achieve health and
environmental equity across all com-
munity lines.
The inclusion of this provision in the
conference report sends a clear mes-
sage to the Environmental Protection
Agency that it must change the way it
goes about doing business. On behalf of
every community in the country which
will benefit from this provision, I
thank the gentleman from North Caro-
lina (Chairman TAYLOR) and the gen-
tleman from Washington (Mr. DICKS)
for their commitment to working with
me on this issue of critical importance.
The conference report also includes a
provision championed by my good
friend, the gentlewoman from Cali-
fornia (Ms. SOLIS), that stops EPA from
intentionally exposing pregnant
women and children to pesticides and
requires the agency to establish stand-
ards which will come down on the side
of public health.
While I am pleased that the afore-
mentioned is included in the con-
ference report, I am greatly concerned
about the reports major cuts in clean
drinking water and conservation pro-
grams. These programs are essential to
protecting our environment and the
health of our citizens. It is offensive
that this Congress has found the money
for tax cuts for the best-off of us in our
society, but not enough for these crit-
ical programs.
Finally, this legislation includes $1.5
billion in emergency funding for vet-
erans health care. Frankly, this money
should have been appropriated before
the July 4 recess. Instead, the majority
played politics with the Senate, and
our veterans were told no.
More than 1 year ago, Democrats
came to this floor with the former Re-
publican chairman of the Committee
on Veterans Affairs, the gentleman
from New Jersey (Mr. SMITH), arguing
that the majority was shortchanging
veterans health care by more than $1
billion. What did the majority do about
our concerns? Absolutely nothing.
Democrats got stonewalled, the gen-
tleman from New Jersey (Mr. SMITH)
lost his job, and Americas veterans got
shafted.
This spring, Mr. Speaker, our Demo-
cratic prophesy came true. The Bush
administration finally admitted that it
had pushed a budget which short-
changed veterans health care by some
$1 billion. Democrats countered that $1
billion still was not enough, and the
administration waffled. Eventually and
embarrassingly, the Bush administra-
tion finally admitted that the actual
shortfall was closer to $1.5 billion, the
amount appropriated in this conference
report.
How is it that this body can willingly
authorize sending our troops into
harms way, yet refuse to provide them
with the health care benefits they were
promised? I am pleased that the other
body has the backbone to fix what is
wrong, but I am not pleased by the ef-
forts of the administration and House
Republicans to cover up these short-
falls. Shame on all of us for letting this
happen.
Mr. Speaker, individuals on their
own are not going to conduct major en-
vironmental restoration, force power
companies to reduce toxic emissions
from their smokestacks, or clean up
our Nations drinking water. But col-
lectively, collectively, we can all make
this happen.
Enforcement is not free, and neither
is environmental restoration. Is there
anybody in this body who is unwilling
to pay just a little more to ensure that
every American has clean air to breath
and safe drinking water? If given the
chance, who would not be willing to
pool his or her resources with others in
their neighborhood to collectively en-
sure that everyone has safe drinking
water, or that no child would be forced
to grow up playing in backyards pol-
luted by dangerous levels of mercury
and other toxins?
I will most likely support the under-
lying conference report, but I say to
my colleagues, we had an opportunity
to do more in this conference report.
Our willingness to do so, however, was
the missing ingredient.
Mr. Speaker, I reserve the balance of
my time.
Mr. BISHOP. Mr. Speaker, I yield 2
minutes to the gentleman from Arkan-
sas (Mr. BOOZMAN).
Mr. BOOZMAN. Mr. Speaker, I thank
the gentleman for yielding me this
time, and I appreciate all of the hard
work in crafting the Interior bill, the
conference report; and I very much
support it.
I really rise today, though, to talk
about something a little bit different.
Mr. Speaker, in a few hours, U.S. Army
Sergeant Arthur Raymond McGill will
be laid to rest. A third district native,
Sergeant McGill gave his life serving
his country in Iraq when his convoy
detonated an improvised device. I rise
today to mourn this tragic loss and
honor his courageous life.
Sergeant McGill grew up in the
northwest Arkansas communities of
Gentry, Decatur, and Gravette. At the
age of 17, he joined the National Guard
and later enlisted in the Army. He was
on his second tour of duty in Iraq when
he was killed.
Sergeant McGill valued family more
than anything else and wanted to set a
positive example for his daughter,
Kaylee, who his aunt said was the love
of his life. Though his life was cut
short, Sergeant McGill did set a won-
derful example for Kaylee and us all
through his selfless and noble service
to his country.
Mr. Speaker, at the age of 26, Ser-
geant Arthur Raymond McGill made
the ultimate sacrifice for his country.
He is a true American hero, and I cer-
tainly ask my colleagues to remember
his family, remember his friends in
their thoughts and prayers during
these very difficult times.
Mr. HASTINGS of Florida. Mr.
Speaker, I am very pleased to yield 3
minutes to the distinguished gen-
tleman from Massachusetts (Mr.
MCGOVERN), my good friend that I
serve with on the Committee on Rules.
Mr. MCGOVERN. Mr. Speaker, I
thank my colleague, the gentleman
from Florida, for yielding me this
time.
Mr. Speaker, when this House first
considered the Department of Interior
appropriations bill, I came to the floor
to express my deep outrage that this
legislation nearly eliminated funding
for the Land and Water Conservation
Fund.
I join with my colleagues, the gen-
tleman from New York (Mr. KING) and
the gentleman from New Jersey (Mr.
HOLT), in urging that the House and
the Senate conferees restore some level
of funding for this vital program. I am
pleased that 119 Members shared our
concerns about this funding cut and
signed on to our bipartisan letter. Mr.
Speaker, I will insert the letter for the
RECORD at the conclusion of my re-
marks.
The Land and Water Conservation
Fund has been an enormous help to our
local communities and the families
who live in them. The Stateside grant
program has helped to preserve open
space, slow urban sprawl, and give our
children safe places to play.
b 1030
It is a true partnership with Federal
grants requiring a full match from
States and local communities. In all,
the stateside program has helped com-
munities by funding 40,000 projects na-
tionally. Success stories can be found
in every State and in 98 percent of U.S.
counties.
The Land and Water Conservation
Fund is especially near and dear to my
heart, having led the fight on the floor
of the House back in 1999 to restore $30
million for the stateside grant program
in the fiscal year 2000 Interior appro-
priations bill after it had been zeroed
out in 1995.
In my district, the Land and Water
Conservation Fund State assistance
grants have provided much-needed
funds to restore the historic Worcester
Common in Worcester, Massachusetts,
and renovate the Briggs Pool in Attle-
boro, Massachusetts. We have literally
preserved dozens of acres of open space
that otherwise would have been sold off
for development that would not have
been conducive to these communities.
It has also helped to complete con-
struction this coming fall with the
Princeton playing fields in Princeton,
Massachusetts.
The Land and Water Conservation
Fund is based upon a simple concept. It
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SPA-123
CONGRESSIONAL RECORDHOUSE H6943 July 28, 2005
takes revenues from offshore oil and
gas drilling and invests them in our
Nations public land, letting States
take the lead. For 40 years this pro-
gram has a proven track record and
benefited from strong bipartisan sup-
port.
It was the same bipartisan support
that proved successful here today.
Clearly the level of funding provided in
this bill is far from what is required. In
fact, the level of funding is at the same
level it was when we resuscitated the
program back in 1999. So I am dis-
appointed with that. However, any
amount appropriated to this program,
no matter how small or large, serves a
valuable purpose.
I commend my colleagues for their
hard work. I thank those who helped
reinsert funding for the Land and
Water Conservation Fund back into
this bill. I hope that we can come to
some sort of consensus that next year
we will restore funding to a level that
is adequate, and to a level that we all
promised our constituents.
Mr. Speaker, I will insert for the
RECORD the letter I referred to earlier.
CONGRESS OF THE UNITED STATES,
Washington, DC, July 22, 2005.
DEAR CONFEREE: We are writing to request
that, as you move toward conference with
the Senate on the FY 2006 Interior Appro-
priations Bill, you support the funding levels
that were included for the Land and Water
Conservation Fund (LWCF) in the Senate
passed version of the bill.
Since its creation in 1964, the Land and
Water Conservation Fund (LWCF) has been a
critical source of funding for the National
Park Service, Fish and Wildlife Service, Bu-
reau of Land Management, and Forest Serv-
ice. This funding is used to support the ac-
quisition and maintenance of our national
wildlife refuges, parks, forests, and public
domain lands.
In addition, the LWCF also funds a match-
ing grant program to assist states and local-
ities in acquiring recreational lands and de-
veloping facilities. An integral part of the
LWCF, the state-side matching grant pro-
gram has provided state and local parks and
recreation directors with the desperately
needed funding to help preserve open space
and develop recreational facilities. Over the
years, these matching grants have been used
successfully to fund more than 37,000 state
and local park and recreation projects, ena-
bling millions of Americans to hike through
magnificent scenery and view historic sites,
bike along seaside and river trails, and pic-
nic and play ball at local parks.
The Senate-passed FY 2006 Interior Appro-
priations Bill provides $192 million for
LWCF, which includes $30 million for the
state-side grant program and $162 million for
the federal program. This funding is abso-
lutely essential for the proper stewardship of
our nations magnificent natural heritage,
and therefore, we strongly urge you to main-
tain the funding levels for LWCF state-side
and federal grant programs provided for in
the Senate bill. Thank you for your consider-
ation of this request.
Sincerely,
Jim McGovern, Rush Holt, Peter T. King,
Jim Marshall, Robert E. Andrews, Mi-
chael H. Michaud, Michael M. Honda,
Howard L. Berman, Rahm Emanuel,
Barbara Lee, Donald M. Payne, Dennis
J. Kucinich, Joseph Crowley, Richard
E. Neal, Henry Cuellar, Rob Simmons,
Rosa L. DeLauro, Shelley Berkley,
Allyson Y. Schwartz, Melvin L. Watt,
John Spratt, Jim Oberstar, John
Lewis, Nick Rahall, Scott Garrett, Dan
Lipinski, Mike Doyle, Betty McCollum,
Harold Ford, John T. Salazar, Jim
Langevin, Leonard L. Boswell, Elijah
E. Cummings, Lloyd Doggett, Gene
Green, Nancy L. Johnson, John
Shimkus, Jo Bonner, Spencer Bachus,
Mike McIntyre, Julia Carson, Vito
Fossella, Adam Smith, Doris O. Mat-
sui, Solomon P. Ortiz, Brian Higgins,
Silvestre Reyes, Tammy Baldwin, Mike
Thompson, Charles F. Bass, Tim
Holden, Jay Inslee, Frank Pallone, Jr.,
Martin Meehan, Juanita Millender-
McDonald Ike Skelton, Grace F.
Napolitano, Sander Levin, Jerrold Nad-
ler, Bernard Sanders, Chris Van Hollen,
John B. Larson, George Miller, Tom
Lantos, Gary L. Ackerman, Jim
Matheson, Sherwood Boehlert, Ed Case,
Rau l M. Grijalva, Dale E. Kildee, Jim
McDermott, Earl Blumenauer, Jim
Saxton, Dennis Cardoza, Carolyn
McCarthy, Michael R. McNulty, Ellen
O. Tauscher, Timothy H. Bishop,
Edolphus Towns, Peter DeFazio, An-
thony D. Weiner, John D. Dingell,
Sherrod Brown, Wm. Lacy Clay, Wil-
liam Delahunt, Louise Slaughter, Bar-
ney Frank, Robert Menendez, Eliot L.
Engel, Bobby Scott, Ben Cardin, Tom
Udall, Janice Schakowsky, Bart Gor-
don, Lynn Woolsey, Stephen F. Lynch,
Donna M. Christensen, Thomas Allen,
Thaddeus G. McCotter, Lois Capps,
Emanuel Cleaver, Mike Ferguson, Bart
Stupak, David Price, Lane Evans,
Carolyn B. Maloney, Jeb Bradley,
Steve Israel, Pete Stark, Bob
Etheridge, Mark Udall, Sue W. Kelly,
Jerry F. Costello, Luis V. Gutierrez,
Christopher Shays, Mike Ross, Charles
A. Gonzalez, Neil Abercrombie, Anna
Eshoo.
Mr. HASTINGS of Florida. Mr.
Speaker, I yield back the balance of
my time.
Mr. BISHOP of Utah. Mr. Speaker, I
yield myself such time as I may con-
sume.
Mr. Speaker, I appreciate all of the
discussion that has gone through on
this particular bill. We have had it on
several different occasions. There are a
lot of good things that are in this par-
ticular bill.
The gentleman from Florida (Mr.
HASTINGS) has mentioned the one por-
tion of the $1.5 billion to solve the hole
in the veterans funding area, that once
the issue was validated could have been
an easy chance for people to grand-
stand. But I am very proud of this en-
tire Congress in a bipartisan way, who
gave instructions in a bipartisanship
way, which came as close to a unani-
mous vote as I have seen here on the
floor.
Mr. Speaker, it is an appropriate step
to do, to now take this and then review
the process so that we can continue to
go on. We have much to do in this par-
ticular area, but in each year that I
have been here in this Congress, I have
been very proud that we have tried to
move forward in different areas and
make progress to fully fund and fully
maintain our commitments.
The same thing has gone on with all
of the other programs in this par-
ticular budget and this particular con-
ference report. This committee has
once again done a great job in trying to
come up with the principle that all ap-
propriators ought to be doing a
prioritizing program. They have
prioritized the programs. Mr. Speaker,
overall, we can be very positive of that.
Mr. DICKS. Mr. Speaker, I rise in support of
this rule to allow for the consideration of the
conference report on the fiscal year 06 Interior
and Environment Appropriations bill. And I in-
tend to intend to vote for the conference bill.
Although I am critical of several aspects of
this billincluding the low overall spending
levelwithout a doubt this process has been
fair and open. Because of the low allocation,
there are some problem areas.
But the overall conference report is well
worth supporting. With the addition of $1.5 bil-
lion in spending for Veterans health care at-
tached to this bill, I believe that this con-
ference report will get widespread support in
both the House and the Senate.
The conference agreement contains another
year of healthy increases in National Park
Service operations funding. I do wish that the
Clean Water Act State Revolving Fund was
higher. I also wish that the Conference Report
had retained the extra $10 million in NEA
funding that the full House approved in a floor
amendment last May. It is important to point
out that this agreement contains successful
compromises on the issue of pesticide testing
on humans and on federal funding for the
Martin Luther King, Jr. Memorial to be built on
the National Mall.
Again I want to reiterate my strong support
for this rule and the conference report on the
fiscal year 06 Interior and Environment Appro-
priations bill. And I want to thank Chairman
TAYLOR and his staff for including the minority
throughout this process.
Mr. BISHOP of Utah. Mr. Speaker, I
yield back the balance of my time, and
I urge the Members to support the rule
that provides for consideration of this
conference report to the accompanying
H.R. 2361, and I move the previous
question on the conference report.
The previous question was ordered.
The SPEAKER pro tempore (Mr.
SIMPSON). The question is on the con-
ference report.
The question was taken; and the
Speaker pro tempore announced that
the ayes appeared to have it.
Mr. HENSARLING. Mr. Speaker, on
that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursu-
ant to clause 8 of rule XX further pro-
ceedings on this question will be post-
poned.
f
WAIVING POINTS OF ORDER
AGAINST CONFERENCE REPORT
ON H.R. 6, ENERGY POLICY ACT
OF 2005
Mr. HASTINGS of Washington. Mr.
Speaker, by direction of the Com-
mittee on Rules, I call up House Reso-
lution 394 and ask for its immediate
consideration.
The Clerk read the resolution, as fol-
lows:
H. RES. 394
Resolved, That upon adoption of this reso-
lution it shall be in order to consider the
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CONGRESSIONAL RECORDHOUSE H7013 July 28, 2005
Kucinich
Langevin
Lantos
Larsen (WA)
Larson (CT)
Lee
Levin
Lewis (GA)
Lipinski
Lofgren, Zoe
Lowey
Lynch
Maloney
Markey
Marshall
Matsui
McCarthy
McCollum (MN)
McDermott
McGovern
McIntyre
McKinney
McNulty
Meehan
Meek (FL)
Meeks (NY)
Melancon
Menendez
Michaud
Millender-
McDonald
Miller (NC)
Miller, George
Mollohan
Moore (KS)
Moore (WI)
Moran (VA)
Nadler
Napolitano
Neal (MA)
Oberstar
Obey
Olver
Ortiz
Owens
Pallone
Pascrell
Pastor
Payne
Pelosi
Price (NC)
Rahall
Rangel
Reyes
Ross
Rothman
Roybal-Allard
Ruppersberger
Rush
Ryan (OH)
Sabo
Salazar
Sa nchez, Linda
T.
Sanchez, Loretta
Sanders
Schiff
Schwartz (PA)
Scott (VA)
Serrano
Sherman
Skelton
Slaughter
Smith (WA)
Snyder
Solis
Spratt
Stark
Strickland
Stupak
Tanner
Tauscher
Terry
Thompson (CA)
Thompson (MS)
Tierney
Towns
Udall (CO)
Udall (NM)
Van Hollen
Vela zquez
Visclosky
Wasserman
Schultz
Waters
Watson
Watt
Waxman
Weiner
Wexler
Woolsey
Wynn
ANSWERED PRESENT2
Burton (IN) Sensenbrenner
NOT VOTING7
Andrews
Burgess
Carson
Johnson, Sam
Paul
Schakowsky
Wu
ANNOUNCEMENT BY THE SPEAKER PRO TEMPORE
The SPEAKER pro tempore (during
the vote). Members are advised there
are 2 minutes remaining in this vote.
b 1640
So the bill was passed.
The result of the vote was announced
as above recorded.
A motion to reconsider was laid on
the table.
f
FURTHER MESSAGE FROM THE
SENATE
A further message from the Senate
by Ms. Curtis, one of its clerks, an-
nounced that the Senate has passed
without amendment a bill of the House
of the following title:
H.R. 3423. An act to amend the Federal
Food, Drug, and Cosmetic Act with respect
to medical device user fees.
f
GENERAL LEAVE
Mr. TAYLOR of North Carolina. Mr.
Speaker, I ask unanimous consent that
all Members may have 5 legislative
days within which to revise and extend
their remarks and that I may include
tabular and extraneous material on the
conference report to accompany H.R.
2361.
The SPEAKER pro tempore. Is there
objection to the request of the gen-
tleman from North Carolina?
There was no objection.
f
CONFERENCE REPORT ON H.R. 2361,
DEPARTMENT OF THE INTERIOR,
ENVIRONMENT, AND RELATED
AGENCIES APPROPRIATIONS
ACT, 2006
Mr. TAYLOR of North Carolina. Mr.
Speaker, pursuant to House Resolution
392, I call up the conference report on
the bill (H.R. 2361) making appropria-
tions for the Department of the Inte-
rior, environment, and related agencies
for the fiscal year ending September 30,
2006, and for other purposes.
The Clerk read the title of the bill.
The SPEAKER pro tempore. Pursu-
ant to House Resolution 392, the con-
ference report is considered as having
been read.
(For conference report and state-
ment, see proceedings of the House of
July 26, 2005 at page H6562.)
The SPEAKER pro tempore. The gen-
tleman from North Carolina (Mr. TAY-
LOR) and the gentleman from Wash-
ington (Mr. DICKS) each will control 30
minutes.
The Chair recognizes the gentleman
from North Carolina (Mr. TAYLOR).
b 1645
Mr. TAYLOR of North Carolina. Mr.
Speaker, I yield myself such time as I
may consume.
Mr. Speaker, today we bring before
the House the conference agreement on
H.R. 2361, the Interior, Environment,
and Related Agencies Appropriations
Act for fiscal year 2006. I would like to
thank all of the members of the Sub-
committee for their support and guid-
ance this year. I want to extend special
thanks to the subcommittee vice chair-
man, the gentleman from Idaho (Mr.
SIMPSON), and the gentleman from
Washington (Mr. DICKS), the ranking
member and my good friend, for their
assistance in shaping the bill. We are
under last year, and we are under the
allocation.
The conference report balances many
competitive and diverse needs. It pro-
vides funding for programs in the De-
partment of the Interior, the Environ-
mental Protection Agency, the Forest
Service, the Indian Health Agency, the
Smithsonian Institution, and several
other environmental and cultural agen-
cies and commissions.
With the ongoing war on terrorism
and a sizable Federal debt, the Amer-
ican taxpayer demands fiscal prudence,
yet entrusts us to continue the con-
servation and care of our Nations nat-
ural resources, the protection of the
environment, and critical programs for
native Americans and other programs.
The needs far outweigh the funds avail-
able, but I believe this bill addresses
the most critical needs.
The conference report is the product
of a balanced, bipartisan, bicameral ef-
fort that resolves over 2,000 differences
between the House and the Senate
bills. Moreover, it addresses many of
the key issues raised on the House
floor in May and stays true to the fun-
damental issues that helped the bill
pass overwhelmingly in the House.
Here are a few of the highlights:
Payments in Lieu of Taxes are $9
million over the enacted level. The arts
and humanities are $5 million each
over the enacted level. Funding for op-
erations of the national parks has in-
creased by $61 million. Restrictions re-
main in the bill for pesticide testing on
human subjects. Funding for the Clean
Water State Revolving Act is $900 mil-
lion, which is $50 million above the
House level and $170 million above the
budget request.
The Forest Health Program, which is
critical to reducing this Nations risk
of catastrophic wildfires, is restored to
the enacted level.
Finally, I am proud to say that this
conference agreement contains $1.5 bil-
lion in critically needed funds for vet-
erans medical care.
Mr. Speaker, I believe the priorities
of the American people are reflected in
the conference agreement, and I urge
all of my colleagues to support it.
I would like to thank staff on both
sides of the aisle because, without their
hard work, we would not be able to
bring this bill forward at this time.
At this time, I will include a table
detailing the various accounts in the
bill for insertion in the RECORD.
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SPA-130
CONGRESSIONAL RECORDHOUSE H7019 July 28, 2005
Mr. Speaker, I reserve the balance of
my time.
Mr. DICKS. Mr. Speaker, I yield my-
self such time as I may consume.
I support this conference report on
the fiscal year 2006 Interior and Envi-
ronment Appropriations bill, and I will
vote for it, in just a few minutes, I
hope. With the addition of $1.5 billion
in spending for veterans health care at-
tached to this bill, I believe that this
conference report will get widespread
support in both the House and the Sen-
ate.
After we made a decision to add this
$1.5 billion, I contacted back in the
State of Washington the veterans hos-
pital in Seattle and the one at Amer-
ican Lake to find out what the backlog
was, and I was shocked to find out that
there is a backlog of some 2,000 vet-
erans who are waiting to get an initial
appointment at those hospitals. So this
money clearly is needed, and I am
pleased that the other body selected
the Interior appropriations to add this
$1.5 billion to and that we were able to
present it here today to the House.
There are several areas of this bill
that I believe are underfunded; how-
ever, I believe these funding decisions
were the result of an inadequate alloca-
tion. Although the majority cannot es-
cape responsibility for this allocation,
I believe that we here in the minority
have been treated fairly during the
process of developing the 2006 Interior
appropriations.
First of all, I want to thank the
chairman, the gentleman from North
Carolina (Mr. TAYLOR), for the decision
to provide the Park Service operating
budget another year of healthy in-
creases. Over the last 2 years, we have
provided more than $100 million in in-
creases for the parks operating budget,
and I am very proud of that accom-
plishment. We really were seeing a de-
cline in some of the parks because they
were not able to cover their fixed costs
on an annual basis and had to lay off
people and were unable to provide the
American people with the services that
they needed.
However, I am disappointed with the
overall amount for the Clean Water
Act State Revolving Fund. I had hoped
that the conference report would end
up closer to the Senate mark of $1.1
billion, rather than at $900 million,
which is only $50 million above the
House mark. Over the last 2 years, this
funding has been cut by 33 percent.
I am also disappointed that we could
not retain the full $10 million increase
for the National Endowment for the
Arts, which was approved on the House
floor in an overwhelming vote, but I
am gratified that we could agree to
some increase for both the NEA and
the NEH.
I am glad to see this conference re-
port contains increases over the House
mark for both land acquisition and the
State grant program. Although these
programs are cut from last year, I
agree with the decision to restore some
of the funding; and I am sympathetic
to the argument that, during a year
with such a low allocation, it is most
important to protect core programs
and make land acquisition a more sec-
ondary goal.
I am deeply appreciative of every-
ones efforts to resolve the issue con-
cerning the use of humans during pes-
ticide testing. I think the conference
report reflects the will of both the
House and Senate to stop such tests
until the EPA develops regulations re-
flecting the recommendation of the Na-
tional Academy of Science and follows
the Nuremburg protocols. In addition,
these regulations will prohibit such
testing on pregnant women, infants,
and children.
I also want to praise the compromise
contained in this conference report on
the Martin Luther King, Jr., memorial
to be built on the National Mall. The
conference report contains $10 million
that must be matched by private dona-
tions. This matching requirement will
spur increased private donations and
reflects the thinking of the chairman,
the gentleman from North Carolina
(Mr. TAYLOR), who felt very strongly
that we should try to raise as much
money for the memorial from the pri-
vate sector.
Again, I want to say that the chair-
man has been very fair and his staff,
led by Debbie Weatherly, has done an
outstanding job in putting together
this bill. I want to congratulate Mike
Stevens and Pete Modoff of my staff for
the exceptional work they did on this
bill. I think this is, in a very difficult
year, I think this is a bill that deserves
our support.
Mr. Speaker, I yield 5 minutes to the
distinguished gentleman from Wis-
consin (Mr. OBEY), the ranking Demo-
crat of the full Committee on Appro-
priations.
Mr. OBEY. Mr. Speaker, I thank the
gentleman for yielding me this time. I
would simply like to say that this is a
close call on this bill as far as I am
concerned; but weighing all of the con-
flicting pressures, I come down on the
side of recommending a vote for the
bill, primarily because of what it does
to finally provide sufficient funding for
veterans health care.
With respect to that item, I would
simply say to our friends on the major-
ity side of the aisle, welcome aboard.
We tried for the last year and a half to
convince this administration and to
convince the majority that the vet-
erans health accounts were under-
funded. Finally, the administration ad-
mitted that that was true; and, in fact,
the amount being added to this bill
today for veterans health care is ex-
actly the amount that we had been
asking be added to that program for
that purpose for a long period of time.
I want to make clear, the shortfall
for veterans health care is not the re-
sponsibility of the chairman of this
subcommittee. This problem is sup-
posed to be taken care of by another
subcommittee; but, in fact, after run-
ning away from the problem for
months and months, the majority
party has finally decided that they did
not want to go home in August and
have to face the folks at the Legion
hall or the VFW hall without finally
doing something to fix the problem. So
I am glad that they did.
But even though I am going to vote
for this bill because of what it does for
veterans, I think we need to under-
stand that in a number of other areas,
this bill is far from where it ought to
be if we are to meet the responsibilities
that we have to this countrys future.
Overall, funding for the EPA declines
by $291 million in this bill. The Clean
Water State Revolving Fund has now
been cut by 33 percent over 2 years.
Grants to States for conservation and
recreation are reduced by two-thirds
from fiscal year 2005. Every State suf-
fers a 66 percent cut.
In the year 2001, land acquisition
funds in this bill were $442 million.
Today, they are $124 million. That is
the lowest appropriation for this item
in the past 20 years. Construction fund-
ing for national parks and refuges and
forests has been reduced by about 10
percent from last year. The funding for
Forest Service buildings, roads, and
trails has been cut from $514 million to
$441 million, a reduction of 14 percent.
BIA school construction is funded at
a level $53 million below last year.
Health facilities construction for In-
dian health services is funded at $38
million, a reduction of $50 million. I do
not believe those numbers are numbers
that we would be proud to take home.
So we are stuck with a choice. We
can cast a protest vote against the cuts
in this bill, which many of us have al-
ready done; or we can recognize the
fact that in a time of war we have an
obligation to meet the health care
needs of those who have risked every-
thing for this country; and I think we,
in the end, have no real choice but to
come down in favor of voting for that
increased veterans funding.
But I hope that the general public
will understand that the cuts in this
bill do the Nation no favors. We are
shortchanging our countrys future. We
are not meeting our stewardship re-
sponsibilities, and we will pay a long-
term price for that, I regret to say.
Mr. Speaker, let me say one other
thing. I do want to express my appre-
ciation to the subcommittee chairman
for the fairness with which he has dealt
with this bill. I may not agree with the
priorities that the majority party
budget resolution imposed on the sub-
committee, but I do want to say that I
think the chairman has been most fair
in his dealing with the minority; and
we appreciate that.
Mr. TAYLOR of North Carolina. Mr.
Speaker, I reserve the balance of my
time.
Mr. DICKS. Mr. Speaker, I yield 5
minutes to the distinguished gen-
tleman from South Carolina (Mr.
SPRATT), who is one of the leaders in
this House on budget matters.
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SPA-131
CONGRESSIONAL RECORDHOUSE H7020 July 28, 2005
Mr. SPRATT. Mr. Speaker, I thank
the gentleman for yielding me this
time.
Mr. Speaker, I rise in full support of
the $1.5 billion in veterans health care
funding for 2005, which was added on to
this conference report. I am pleased
that my colleagues on the other side
have finally come around to our posi-
tion on veterans funding and now ac-
knowledge that their budgets have not
funded this priority accurately or ade-
quately.
This shortfall has not occurred for
lack of notice or foresight. Over warn-
ings from veterans groups and our own
strenuous objections, the budgets
passed by this House have consistently,
consistently, understated the cost of
veterans health care.
b 1700
This is the Veterans Administration
borrowing from Peter to pay Paul, de-
nying or delaying service until a sup-
plement finally comes through. And
then when the supplement comes
through, it busts the spending caps im-
posed in the budget and adds to the def-
icit.
This is no way to budget for veterans
health care, and it is no way to budget
generally. The White House just 2
weeks ago issued a midsession review
of the budget, which we received with
some skepticism. We observed that
their projections of the deficit seemed
better, partly because they omit the
full cost of various policies like vet-
erans health care, the ongoing cost of
operations in Afghanistan and Iraq,
and fixing the alternative minimum
tax, extending other tax credits.
In the short run, these omissions
make the deficit look better, sure, but
in the long run the true costs emerge,
and the actual deficits turn out to be
worse than projected.
Here, for example, is what happened
to veterans health care in the fiscal
2005 budget cycle. When we brought
forth our budget resolutions on the
Democratic side for 2005, we argued
that the discretionary spending levels
in the Republican resolution were too
tight, not realistic, and would short-
change essential priorities like vet-
erans health care.
We were not alone. The chairman of
the Veterans Affairs Committee ar-
gued that more funding for veterans
health care was badly needed, but our
concerns went unheeded. Now we have
to face the truth. The funding provided
for veterans health care in the 2005
budget was, in fact, not sufficient.
And since an accurate funding level
was not built into the budget, todays
bill will move discretionary spending
for 2005 over the allocation included in
the Republican budget. This
misestimate, like others, was left out
of the deficit projections that OMB an-
nounced just a couple of weeks ago.
For the record, let me point out that
the Democrats put forth a responsible
budget for 2005. Our budget brought us
to balance by the year 2012, yet we
funded veterans health care priorities
and other priorities adequately.
Our budget provided $1.3 billion more
for veterans health care in 2005, and
$1.5 billion more over a 5-year period of
time. Unfortunately the same story is
playing out, unfolding again in 2006.
Once again, once again, this year we
warned that the budget provided too
little for veterans health care, and
once again it was to no avail.
Our resolution provided $1.5 billion
more for veterans health care in 2006,
$16.4 billion more over 5 years, and a
budget, mind you, that balanced by
2012. Just 3 months later, 3 months
later, we are told that the VA appro-
priations bill for 2006 will have to ex-
ceed its budget allocation to accommo-
date the administrations amended re-
quest for veterans health care. And, of
course, the deficit estimates for 2006
will have to be revised upward accord-
ingly.
Mr. Speaker, I would gladly vote to
raise veterans health care to the level
it should have been to start with, but I
urge that we learn a lesson from this
experience and be forthright in the fu-
ture about the cost of veterans health
care. And in that connection, I would
note that in the outyears, 2007, 2008 and
onward, the official estimates of the
Republican budget still grossly
underfund veterans health care, they
understate the deficit, and they defi-
nitely will have to do this all over
again until the numbers are finally
done right.
Mr. DICKS. Mr. Speaker, I yield 2
minutes to the gentlewoman from Cali-
fornia (Ms. SOLIS), who has been a real
leader on the issue of dealing with pes-
ticides and their effect on humans.
(Ms. SOLIS asked and was given per-
mission to revise and extend her re-
marks.)
Ms. SOLIS. Mr. Speaker, I thank the
gentleman for yielding me time.
Mr. Speaker, I rise in support of the
Interior-Environment appropriations
bill. I want to especially thank the
gentleman from California (Mr. LEWIS),
the gentleman from Wisconsin (Mr.
OBEY), the gentleman from North Caro-
lina (Mr. TAYLOR) and the gentleman
from Washington (Mr. DICKS), the
ranking, for their work on this legisla-
tion.
I am particularly proud of the steps
that Congress has taken today to re-
quire the application of stringent eth-
ical and scientific safeguards of inten-
tional human dosing studies, and to
stop the testing of pesticides on preg-
nant women and children. And I would
like to thank all of your staff for their
leadership on this issue.
Mr. DICKS. Mr. Speaker, will the
gentlewoman yield?
Ms. SOLIS. I yield to the gentleman
from Washington.
Mr. DICKS. Mr. Speaker, I want to
congratulate the gentlewoman on her
hard work on this. I can remember
when we had the amendment on the
floor. It was adopted here in the House
unanimously. And I think your work
and the work of your colleague from
California in the other body on this
matter, where they also won a vote
there, too, was very impressive.
And, you know, this is the first year
our committee has had jurisdiction
over the Environmental Protection
Agency, so we are all learning about
these issues. I want to congratulate
you on your real leadership. And I
think what you did will be something
that will protect children and pregnant
mothers and will bring better stand-
ards at EPA on this issue. I congratu-
late you on this effort.
Ms. SOLIS. Mr. Speaker, reclaiming
my time, I would like to also submit
that our staffs have worked very hard,
and the outside organizations that
worked in tandem with us, religious or-
ganizations, the scientific, environ-
mental community, as well as activ-
ists. In fact, the United Farm Workers
also submitted a letter of support.
This should never have happened. It
should never have taken place, the
testing of pesticides on humans, and
particularly children.
So I know that I stand here before
you in the Congress to say that this is
a good moment for us in this particular
time. Thank you very much.
Mr. Speaker, as co-sponsor of this amend-
ment, I rise today to support the application of
stringent ethical and scientific safeguards to
intentional human dosing studies of toxic
chemicals and applaud the inclusion of this
language in the Interior-Appropriation bill.
This amendment forbids the EPA from con-
sidering any intentional human dosing study
unless it meets the minimum ethical and sci-
entific safeguards outlined in the February
2004 National Academy of Sciences report
and the 1947 Nuremberg Code adopted after
World War II. I am submitting copies of the
NAS report and the Nuremberg Code into the
RECORD.
In particular, this amendment prohibits inten-
tional human dosing on pregnant women, in-
fants, or children, and requires the creation of
a review board to evaluate the ethical and sci-
entific propriety of intentional human dosing
studies before they can be conducted, consid-
ered, or relied on. In 2002, the National Acad-
emy of Sciences convened a panel to exam-
ine the issue of intentionally dosing human
subjects with pesticides and other toxic sub-
stances.
The report of the NAS, published in Feb-
ruary 2004, recognized that these experiments
can be troubling and in some cases repug-
nant. For this reason, the NAS concluded
that to be ethically justified, a human pes-
ticide experiment must pass rigorous scrutiny
on both scientific and ethical grounds.
All of the studies currently pending before
EPA are scientifically and ethically suspect
and appear to fall far short of the stringent cri-
teria for EPA consideration outlined by the
NAS and the Nuremberg Code, and required
in this amendment. EPA provided Congress
with a list of all human intentional dosing tests
under consideration by the agency. An exten-
sive evaluation of these tests shows that they
are rife with ethical and scientific flaws and do
not approach the standard for acceptability.
Representative WAXMAN and Senator BOXER
evaluated the serious flaws in these studies in
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SPA-132
CONGRESSIONAL RECORDHOUSE H7021 July 28, 2005
a report released last month entitled Human
Pesticide Experiments, which I am submitting
into the RECORD.
It is also clear that EPAs draft regulation re-
garding human testing similarly fails to meet
the minimum criteria required in this amend-
ment. EPA circulated internally a draft rule
among the agencys various offices on June
20, 2005. EPAs draft rule, slated for proposal
next month, would have allowed the system-
atic testing of pesticides on humans. The draft
rule does not comply with the recommenda-
tions of the NAS and the Nuremberg Code,
and it contains multiple loopholes that invite
abuse.
The EPA draft is inconsistent with the stand-
ards we require in this amendment. EPA origi-
nally commenced its rulemaking in response
to a wave of industry pressure to permit inten-
tional dosing of human test subjects with toxic
chemicals.
The pesticide industry has mounted a cam-
paign to expand testing of pesticides on hu-
mans in order to weaken health standards.
Because of the stricter requirements imposed
by the Food Quality Protection Act of 1996,
the pesticide industry has been under growing
pressure to reduce the risks that pesticides
pose to infants and children. The industry has
adopted a strategy to evade these require-
ments by testing pesticides on a small number
of adult human subjects, and then cite these
tests to argue that the chemicals are safe.
EPAs proposed rule encourages this strat-
egy and is contrary to the recommendations of
the NAS and the ethical guidelines of the Nur-
emberg Code that we require in this amend-
ment. I am submitting for the record a June
2005 report titled Flash Report: New EPA Pro-
posal Encourages Human Pesticide Experi-
ments.
As outlined in more detail in this report,
EPAs proposed rule violates the ethical and
scientific safeguards now required by this
amendment, by failing to establish a national
review panel to prevent abusive experiments,
and by failing to provide full protections for
children and other vulnerable populations.
Furthermore, the EPA draft rule does not
clearly require that pesticide experiments com-
ply with even its sub par standards. To the
contrary, EPA proposed to accept all experi-
ments as long as they substantially comply.
This provision overtly undercuts the protec-
tions in the rule. The vague standard of sub-
stantial compliance wrongly sends the signal
that EPA will not demand strict adherence to
ethical standards in human pesticide experi-
ments.
Intentional human toxicity testing has a trou-
bling history that includes manipulation and
abuse of the most vulnerable members of so-
ciety. The amendment that I am supporting
today will ensure that EPA may not consider
or rely on any intentional human-dosing study
that does not meet the minimum ethical and
scientific criteria recommended by the NAS
and expressed in the Nuremberg Code.
Mr. TAYLOR of North Carolina. Mr.
Speaker, I would yield such time as he
may consume to the gentleman from
California (Mr. LEWIS).
Mr. LEWIS of California. Mr. Speak-
er, I will not consume very much time.
I rise to express my deep appreciation
one more time to my colleague and
friend, the gentleman from Wisconsin
(Mr. OBEY), for his cooperating with me
as we have gone through this initial
conference process, but most impor-
tantly to congratulate both my col-
league, the gentleman from Wash-
ington (Mr. DICKS), and my colleague,
the gentleman from North Carolina
(Mr. TAYLOR), for the fabulous job on
this first of a series of conference re-
ports that we expect to send to the
Presidents desk.
It is very early in the process, but
the Interior bill will be on the Presi-
dents desk, and I am very certain he
will find it to be to his liking. So con-
gratulations to each of you for your
work.
Mr. DICKS. Mr. Speaker, will the
gentleman yield?
Mr. LEWIS of California. I yield to
the gentleman from Washington.
Mr. DICKS. Mr. Speaker, I think this
is a very important moment today that
we are passing this conference report
before the August recess. And I want to
congratulate the chairman and ranking
member, who has really worked tire-
lessly to work with the chairman to
get these bills enacted.
But I think there is absolutely no ex-
cuse not to try to do this and try to
pass the rest of the bills in September
and show the American people that we
can get the job done before the start of
the fiscal year.
And I think every time we have a
new chairman, we do better in this re-
gard. The previous chairman, of course,
had to deal with other problems. But I
think the chairman has made this a big
priority. I think it is important that
we do this, and I want to congratulate
him for his leadership as the new chair-
man of the full committee.
Mr. LEWIS of California. Mr. Speak-
er, reclaiming my time, let me further
say that none of this would have been
done as effectively and with the high
quality reflected in the conference re-
port without the great help of our
staff. They have done a tremendous
job. They are breaking records here. It
is because of the cooperation of the en-
tire committee, the Members and the
staff working together.
Mr. DINGELL. Mr. Speaker, it is with deep
regret that I rise in opposition to this con-
ference report. Let me explain. Mr. Speaker,
this is a bad bill. It guts some of our most im-
portant environmental programs. It seems that
the Republican majority realized what a bad
bill it was and in order to win support for it,
they put $1.5 billion in much needed funds for
veterans healthcare.
Now, Mr. Speaker, I am a pragmatist. I real-
ize that there is no perfect bill. Sometimes we
have to settle for some good and some bad.
The bill before us, however, is a close call.
The problem is a simple one. You see, for
years my Republican colleagues have been
shortchanging our veterans. The number of
veterans treated at VA facilities increased from
2.7 million to 4.7 million from 1995 to 2004.
The Department expects to treat 5.2 million
veterans in 2006. Currently, more than 50,000
veterans are waiting in line for at least 6
months for health services from the VA. Med-
ical costs are increasing at nearly double the
rate of inflation. Yet, over five years, the Re-
publican budget for primarily veterans health
programs is funded $13.5 billion below the
amount needed to maintain services at current
levels.
I am pleased that my Republican colleagues
have finally seen the light and realized that we
cannot ask our men and women in uniform to
make the ultimate sacrifice only to come home
and have the promise of quality and timely
healthcare broken. However, I am angry as
hell that they attached this much needed fund-
ing to a particularly appalling bill.
You are probably saying, Dingell, how ap-
palling could it be when we are finally getting
this funding for our veterans?
Well, let me tell you.
EPA has estimated that there is a $388 bil-
lion shortfall between needed clean water and
drinking water investments and the current
level of spending. What do my Republican col-
leagues do to address that shortfall, Mr.
Speaker? They cut the Clean Water State Re-
volving Loan Fund by $200 million from the
FY 05 enacted level! That is a 33 percent cut
over the past two years. Moreover, the bill
cuts water and sewer construction grants by
more than 30 percenta reduction of $107
million from last year. This hardly seems like
a reasonable response.
Conservation and land acquisition got a $41
million reduction. This is 25 percent below last
years enacted level. Mr. Speaker, my col-
leagues on the other side of the aisle have the
dubious honor of providing the lowest appro-
priation for land and conservation programs in
20 years.
Funding for construction at our National
Parks, Refuges and Forests was cut by ten
percent and funding for Forest Service build-
ings, roads and trails by 14 percent. Stateside
grants for conservation and recreation got an
amazing two-thirds cut, from $90 million last
year to $30 million.
So, you see the conundrum before us.
It is with a heavy heart that I feel that I must
stand against not only a bad bill, but also
against the process. It is unconscionable that
my friends on the other side of the aisle would
link this critically important and much needed
funding for our Nations heroes to a bad bill.
Mr. ETHERIDGE. Mr. Speaker, I rise in re-
luctant support of this conference report.
I am very reluctant to support this bill be-
cause it contains provisions I strongly oppose.
Specifically, this bill contains harmful cuts to
important interior and environmental priorities.
It cuts $800 million from last years funding
level for natural resources and the Environ-
mental Protection Agency. Environmental and
management and science and technology ac-
counts are severely cut in this bill. The bill
cuts $107 million for water and sewer con-
struction STAG grants, cuts $200 million from
SRF clean water funds, and cuts $30 million
from stateside grants to states for conserva-
tion and recreation.
Mr. Speaker, this Congress has a solemn
obligation to protect our Nations water, air
and land resources for public health and safe-
ty. We must practice responsible stewardship
of our natural resources and pass on to future
generations a physical environment as bounti-
ful as the one we have enjoyed. This bill fails
this test miserably.
I will vote for this bill because it contains
desperately needed funding for veterans
health care. Specifically, the conference report
on H.R. 2631 contains $1.5 billion in veterans
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SPA-133
CONGRESSIONAL RECORDHOUSE H7022 July 28, 2005
health care funds to make up for the Adminis-
trations bogus budget proposals. Democrats
in this House have been arguing for months
that the Administration is shortchanging VA
health care, and we should restore that fund-
ing in the proper legislation under regular
order. A nation at war must take care of its
veterans, and I will vote for this bill to provide
this critical funding for veterans health care.
Mr. HOLT. Mr. Speaker, I rise to express
my disappointment with the Interior Appropria-
tions bill that we are considering today. Al-
though I will reluctantly vote for this legislation,
I am concerned with the reduction in funding
for many important domestic programs.
While I am pleased that this conference bill
does not completely eliminate the Land and
Water Conservation Fun, (LWCF), as in the
House-passed version, I am still disappointed
that this program only received $30 million,
which is one-third of what it received last year.
The Land and Water Conservation Fund
has been instrumental in assisting local and
State governments preserve vital open
spaces. This program was established in 1965
to address rapid overdevelopment by increas-
ing the number of high quality recreation areas
and facilities and by increasing the local in-
volvement in land preservation. To achieve
this goal, the fund was separated into two
components, one portion of the fund serves as
an account from which the Federal govern-
ment draws from to acquire land and the other
portion is distributed to states in a matching
grant program.
New Jersey has been active in seeking
grants from this program and has received
funds from the LWCF that were used to pre-
serve treasures such as the Pinelands Na-
tional Reserve and the Delaware National
Scenic River. In addition, LWCF has provided
more that $111 million in state and local
grants to build softball fields, rehabilitate play-
grounds and to expand state parks.
Urban and highly developed regions, such
as the region that I represent, will suffer the
most from the elimination of the LWCF state
grant program. The LWCF matching-grant pro-
gram has proven to be a successful way to
overcome the high cost of living that makes
land acquisition and renewal projects costly in
these regions. The steep reduction in funding
for this program will leave local leaders with-
out the capital necessary to enhance the qual-
ity of life in their communities.
This bill also cuts other domestic programs
that benefit all Americans and future genera-
tions. This legislation only provides $900 mil-
lion for the Clean Water State Revolving
Funda reduction of $200 million from last
year. This is vitally important to keeping drink-
ing water clean and safe by supporting waste-
water treatment, nonpoint source pollution and
watershed and estuary management. Addition-
ally, this bill cuts Federal land acquisition fund-
ing by 25 percent and reduces funding for
construction projects in our national parks, ref-
uges and forests by 10 percent.
Despite my reservations with cuts to impor-
tant Environmental Protection Agency, EPA,
and the Department of Interior, DOI, pro-
grams, I am pleased that this bill does the
right thing and finally provides the VA the
funds it needs to continue the delivery of care
to our veterans through the end of the current
fiscal year. This month, our Nation marked the
75th anniversary of the founding of the Vet-
erans Administration, the forerunner of todays
Department of Veterans Affairs. Even as we
celebrate the VAs many achievements, par-
ticularly in the field of medical research, we
should use this opportunity to ask if we, as a
country, are truly putting our money where our
mouth is regarding VA funding. Every day, VA
doctors, nurses, technicians and other staff
across our country work to try to deliver the
best possible health care to our veterans.
They face one critical and continuing obsta-
clea VA medical system that is chronically,
and needlessly, underfunded.
I hope that the Congress will learn from this
experience and pass mandatory funding legis-
lation for the VA health care system. Its long
past time for Congress to cease its band-aid
approach to funding for veterans health care,
and I urge my colleagues to honor the request
of the leaders of our Nations veterans organi-
zations to deal once and for all with this
shameful and avoidable situation.
Another positive provision in this bill is the
modest increase in funding for the National
Endowment for the Arts and the National En-
dowment for the Humanities. Although the
final funding levels fall slightly short of the
amount approved by the House in May, the
additional money will allow the NEA and NEH
to build programs that use the strength of the
arts and our Nations cultural life to enhance
communities in every State and every county
around America.
It is clear that increasing funding for the arts
and humanities are among the best invest-
ments that we as a society can make. They
help our children learn. They give the elderly
intellectual sustenance. They power economic
development in regions that are down and out.
They tie our diverse society and country to-
gether. I thank the conferees for recognizing
the importance of this investment and giving
the NEA and NEH the funds they need to ad-
vance our Nations artistic and cultural life.
Even though I strongly oppose cuts to cer-
tain programs in this appropriations bill, I will
vote in favor of this legislation. I hope in the
future we can provide sufficient funding to
these programs that enhance our commu-
nities, provide the Nation with clean water,
and protect our precious natural wonders.
Mr. GENE GREEN of Texas. Mr. Speaker,
I rise today in support of this conference re-
port to provide funding for the Department of
the Interior and the Environmental Protection
Agency for fiscal year 2006. Despite a tight al-
location, the Chairman and Ranking Member
of the Interior subcommittee performed an ad-
mirable task in providing the necessary fund-
ing for the continued management of federal
lands and the operation of our countrys envi-
ronmental programs. I was disappointed to
learn, however, that the bill does not provide
much needed funding for a project I requested
for the City of Houston and the University of
Texas, Houston to conduct a risk assessment
of air toxics in the Greater Houston area.
The Houston Chronicle recently completed a
five-part series titled In Harms Way that in-
vestigated air toxics in the fence-line com-
munities near industrial facilities in Houstons
East End. In particular, the series noted that
the Texas Commission on Environmental
Quality found that folks residing in some of
these neighborhoods experience higher levels
of potentially carcinogenic compounds than
other areas.
For many years, residents have had con-
cerns and questions about the quality of the
air in Houstons East End, the potential rela-
tionship to local industry, and the potential
health effects on their families. The City of
Houston, partnering with the University of
Texas School of Public Health, is already
working to characterize the science and weigh
the evidence on health effects. Federal fund-
ing would allow us to broaden the scope of
these efforts to ensure that we include the full
range of risk assessment activities in our effort
to improve the air in Houston.
While I remain disappointed that the Appro-
priations Committee did not include a line-item
appropriation for this project, I am pleased that
my colleague from Washington, the Interior
Subcommittee Ranking Member, recognized
the need for this air toxics assessment and
has agreed to work with me to encourage the
EPA to include this assessment as part of its
fiscal year 2006 operations.
I thank my friend, Mr. DICKS, for his willing-
ness to work with me on this effort. The folks
in these fence-line communitiesmy constitu-
entsare often the workers who produce
many of the essential energy and petro-
chemical products we all use everyday, and
they deserve accurate information about their
environment.
With that, Mr. Speaker, I encourage my col-
leagues to support this bill.
Ms. WOOLSEY. Mr. Speaker, there is an
old saying that, You can put a dress on a pig,
but its still a pig. While I am happy that the
FY06 Interior Appropriations Conference Re-
port includes $1.5 billion to make up for the
funding shortfall for the Veterans Administra-
tion, VA, it does not mask the horrible choices
that were made in the rest of this bill. Its still
a pig. This legislation includes cuts to the
Clean Water State Revolving Fund, decreases
in the number of STAG grants, and completely
eliminates many conservation grants.
Ensuring that the VA has the funding it
needs is one of my highest priorities, which is
why I am so disappointed that this money was
included in a bill that undermines our environ-
ment. It is sad that veterans have been short-
changed by President Bush who was all to
eager to send troops off to war, but failed to
account for the cost of their care after they
had dutifully served their country. The under-
estimation by the White House of $1.5 billion
for this year is only the tip of the iceberg with
the shortfall for next year already projected to
be $2.6 billion. Unfortunately, the shortsighted-
ness of the Republican majority failed to in-
clude this spending where it should be, in the
Military Quality of Life Appropriations bill.
However, Mr. Speaker, in spite of the short-
comings for the environment, I will vote for this
bill to support our troops.
Mr. SALAZAR. Mr. Speaker, I rise today to
express my strong support for the conference
report on H.R. 2361, the Interior Appropria-
tions bill. This important piece of legislation
provides $1.5 billion to remedy the shortfall in
veterans health care for this year. Earlier this
month, I stood here urging this body to step
up to the plate when it comes to veterans. Our
veterans must be our number one priority. By
passing this measure, we take the first step in
fulfilling our obligation to the men and women
who have served our country with honor and
dignity.
Passage of this bill is a necessityI will
never turn my back to our Nations veterans.
However, I do want to take this opportunity to
discuss my concerns with the larger measure
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CONGRESSIONAL RECORDHOUSE H7023 July 28, 2005
and its failure to address the land and water
conservation and management needs of our
nation. The Land and Water Conservation
Fund has been a valuable program for my dis-
trict. This has been a fund to assist commu-
nities in helping preserve open space to pro-
tect and conserve unique landscapes. The cut
in funding for the Land and Water Conserva-
tion Fund is a cut in land conservation for Col-
orado.
For those who know, the 3rd Congressional
District is comprised of rural communities con-
taining millions of acres of public lands. These
public lands are managed by the U.S. Forest
Service, Bureau of Land Management, Na-
tional Park Service, and the Fish and Wildlife
Service. These agencies and public lands pro-
vide many benefits for the local communities
in my district. I am disappointed with the de-
crease in funding to these agencies in this
years Interior Appropriations Conference Re-
port. These agencies have to maintain a dif-
ficult balance of managing our nations public
lands with budget constraints. By cutting fund-
ing to these agencies it makes it very difficult
for them to maintain their current management
practices and leaves our nations public lands
in jeopardy.
With that being said, this report does have
some positive aspects. The funding of $5.6 bil-
lion for Indian programs is beneficial for school
and hospital construction, education grants,
human services programs, and law enforce-
ment needs. These programs are essential for
the Native American reservations within my
district.
More often than not, in the West, the Fed-
eral Government is not just your neighbor, it is
the entire neighborhood. Since most of my
district cannot raise taxes, Payment in Lieu of
Funding is vital. These counties with public
lands within their boundaries need this funding
for schools, roads, and other infrastructure
needs. This program has never been fully
funded, yet my counties are dependent upon
this program. I hope to see this program fully
funded next year.
I also want to see continued funding for the
National Fire Plan and the forest health initia-
tives. These programs need to see increased
funding due to the continued drought periods
in the West and the current pine beetle epi-
demic. If the beetle infestations are not ad-
dressed, we will continue to see our forests
decimated. These insects will continue to
cause fire hazards in our nations forests if we
do not get them under control.
I urge Congress next year to fully fund
these agency budgets. This is critical to the
Western States and our existence.
Finally, Mr. Speaker, I would like to thank
Representatives OBEY and DICKS for their as-
sistance in securing $100,000 for Montroses
City Hall Renovation Project. The City Hall
building of Montrose was built in 1926 and has
been well preserved throughout the years.
However, as the City and County continues to
grow, so too must the building in order to ac-
commodate the needs of the people. Pre-
serving and expanding the City Hall building in
Montrose will allow us to keep a part of history
alive for future generations of Colorado. Mr.
Speaker once again I urge my colleagues to
vote in favor of this legislation. We need to
sure up our VA budget so we can continue to
provide critical health care services to our na-
tions veterans. In the future we need to re-
store the Land and Water Conservation fund-
ing and fully fund our agencies budgets.
Mr. TAYLOR of North Carolina. Mr.
Speaker, I have no further requests for
time, and I yield back the balance of
my time.
Mr. DICKS. Mr. Speaker, I have no
further requests for time, and I yield
back the balance of my time.
The SPEAKER pro tempore (Mr.
WALDEN of Oregon). Without objection
the previous question is ordered on the
conference report.
There was no objection.
The SPEAKER pro tempore. The
question is on the conference report.
Pursuant to clause 10 of rule XX the
yeas and nays are ordered.
Pursuant to clause 8 of rule XX fur-
ther proceedings on this question will
be postponed.
f
GENERAL LEAVE
Mr. LEWIS of California. Mr. Speak-
er, I ask unanimous consent that all
Members may have 5 legislative days
within which to revise and extend their
remarks and that I may include tab-
ular and extraneous material on the
conference report to accompany H.R.
2985.
The SPEAKER pro tempore. Is there
objection to the request of the gen-
tleman from California?
There was no objection.
f
CONFERENCE REPORT ON H.R. 2985,
LEGISLATIVE BRANCH APPRO-
PRIATIONS ACT, 2006
Mr. LEWIS of California. Mr. Speak-
er, I call up the conference report on
the bill (H.R. 2985), making appropria-
tions for the Legislative Branch for the
fiscal year ending September 30, 2006,
and for other purposes.
The Clerk read the title of the bill.
The SPEAKER pro tempore. Pursu-
ant to House Resolution 396, the con-
ference report is considered read.
(For conference report and statement
see proceedings of the House of July 26,
2005 at Page H6628.)
The SPEAKER pro tempore. The gen-
tleman from California (Mr. LEWIS) and
the gentleman from Wisconsin (Mr.
OBEY) each will control 30 minutes.
The Chair recognizes the gentleman
from California (Mr. LEWIS).
Mr. LEWIS of California. Mr. Speak-
er, I yield myself such time as I might
consume. I do not expect that we will
use very much of our time, Mr. Speak-
er.
The conference report I bring forth
today to fund the legislative branch in-
volves those activities providing some
$3 billion, 800 million, an increase of 4.5
percent over the year 2005.
Mr. Speaker, the adjustments upward
almost entirely represent increased ex-
penditures for our police services and
security around the Capitol campus,
and, beyond that, expenses that are di-
rectly related to the development of
the Congressional Visitors Center.
Otherwise the bill is absolutely flat
in terms of spending over 20052006. It
is a very, very lean bill. I urge the
Members to support the bill.
Mr. Speaker, I submit the following
for the RECORD:
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SPA-135
CONGRESSIONAL RECORDSENATE S7551 June 29, 2005
Fulton Street in Brooklyn, New York, shall
be known and designated as the Congress-
woman Shirley A. Chisholm Post Office
Building.
(b) REFERENCES.Any reference in a law,
map, regulation, document, paper, or other
record of the United States to the facility re-
ferred to in subsection (a) shall be deemed to
be a reference to the Congresswoman Shirley
A. Chisholm Post Office Building.
f
BOONE PICKENS POST OFFICE
The bill (S. 775) to designate the fa-
cility of the United States Postal Serv-
ice located at 123 W. 7th Street in
Holdenville, Oklahoma, shall be known
and designated as the Boone Pickens
Post Office was read the third time
and passed, as follows:
Be it enacted by the Senate and House of Rep-
resentatives of the United States of America in
Congress assembled,
SECTION 1. BOONE PICKENS POST OFFICE.
(a) DESIGNATION.The facility of the
United States Postal Service located at 123
W. 7th Street in Holdenville, Oklahoma,
shall be known and designated as the Boone
Pickens Post Office.
(b) REFERENCES.Any reference in a law,
map, regulation, document, paper, or other
record of the United States to the facility re-
ferred to in subsection (a) shall be deemed to
be a reference to the Boone Pickens Post
Office.
f
BRIAN P. PARRELLO POST OFFICE
BUILDING
The bill (S. 904) to designate the fa-
cility of the United States Postal Serv-
ice located at 1560 Union Valley Road
in West Milford, New Jersey, as the
Brian P. Parrello Post Office
Buildingwas read the third time and
passed, as follows:
Be it enacted by the Senate and House of Rep-
resentatives of the United States of America in
Congress assembled,
SECTION 1. BRIAN P. PARRELLO POST OFFICE
BUILDING.
(a) DESIGNATION.The facility of the
United States Postal Service located at 1560
Union Valley Road in West Milford, New Jer-
sey, shall be known and designated as the
Brian P. Parrello Post Office Building.
(b) REFERENCES.Any reference in a law,
map, regulation, document, paper, or other
record of the United States to the facility re-
ferred to in subsection (a) shall be deemed to
be a reference to the Brian P. Parrello Post
Office Building.
f
DALIP SINGH SAUND POST OFFICE
BUILDING
The bill (H.R. 120) to designate the
facility of the United States Postal
Service located at 30777 Rancho Cali-
fornia Road in Temecula, California, as
the Dalip Singh Saund Post Office
Building was read the third time and
passed.
f
SERGEANT FIRST CLASS JOHN
MARSHALL POST OFFICE BUILD-
ING
The bill (H.R. 289) to designate the
facility of the United States Postal
Service located at 8200 South Vermont
Avenue in Los Angeles, California, as
the Sergeant First Class John Mar-
shall Post Office Building was read
the third time and passed.
f
ARTHUR STACEY MASTRAPA POST
OFFICE BUILDING
The bill (H.R. 324) to designate the
facility of the United States Postal
Service located at 321 Montgomery
Road in Altamonte Springs, Florida, as
the Arthur Stacey Mastrapa Post Of-
fice Building was read the third time
and passed.
f
RAY CHARLES POST OFFICE
BUILDING
The bill (H.R. 504) to designate the
facility of the United States Postal
Service located at 4960 West Wash-
ington Boulevard in Los Angeles, Cali-
fornia, as the Ray Charles Post Office
Building was read the third time and
passed.
f
LINDA WHITE EPPS POST OFFICE
The bill (H.R. 627) to designate the
facility of the United States Postal
Service located at 40 Putnam Avenue
in Hamden, Connecticut, as the Linda
White-Epps Post Office was read the
third time and passed.
f
SERGEANT BYRON W. NORWOOD
POST OFFICE BUILDING
The bill (H.R. 1001) to designate the
facility of the United States Postal
Service located at 301 South
Heatherwilde Boulevard in
Pflugerville, Texas, as the Sergeant
Byron W. Norwood Post Office Build-
ing was read the third time and
passed.
f
JUDGE EMILIO VARGAS POST
OFFICE BUILDING
The bill (H.R. 1072) to designate the
facility of the United States Postal
Service located at 151 West End Street
in Goliad, Texas, as the Judge Emilio
Vargas Post Office Building was read
the third time and passed.
f
FRANCIS C. GOODPASTER POST
OFFICE BUILDING
The bill (H.R. 1082) to designate the
facility of the United States Postal
Service located at 120 East Illinois Av-
enue in Vinita, Oklahoma, as the
Francis C. Goodpaster Post Office
Building was read the third time and
passed.
f
MAYOR TONY ARMSTRONG
MEMORIAL POST OFFICE
The bill (H.R. 1236) to designate the
facility of the United States Postal
Service located at 750 4th Street in
Sparks, Nevada, as the Mayor Tony
Armstrong Memorial Post Office was
read the third time and passed.
f
CAPTAIN MARK STUBENHOFER
POST OFFICE BUILDING
The bill (H.R. 1460) to designate the
facility of the United States Postal
Service located at 6200 Rolling Road in
Springfield, Virginia, as the Captain
Mark Stubenhofer Post Office Build-
ing was read the third time and
passed.
f
ED EILERT POST OFFICE
BUILDING
The bill (H.R. 1524) to designate the
facility of the United States Postal
Service located at 12433 Antioch Road
in Overland Park, Kansas, as the Ed
Eilert Post Office Building was read
the third time and passed.
f
HONORABLE JUDGE GEORGE N.
LEIGHTON POST OFFICE BUILDING
The bill (H.R. 1542) to designate the
facility of the United States Postal
Service located at 695 Pleasant Street
in New Bedford, Massachusetts, as the
Honorable Judge George N. Leighton
Post Office Building was read the
third time and passed.
f
FLOYD LUPTON POST OFFICE
The bill (H.R. 2326) to designate the
facility of the United States Postal
Service located at 614 West Old County
Road in Belhaven, North Carolina, as
the Floyd Lupton Post Office was
read the third time and passed.
f
MEASURES PLACED ON CAL-
ENDARS. 590, S. 867, S. 892, S.
1206, AND S. 1207
Mr. BURNS. Mr. President, I ask
unanimous consent that the Com-
mittee on Homeland Security and Gov-
ernmental Affairs be discharged from
further consideration of S. 590, S. 867,
S. 892, S. 1206, and S. 1207 en bloc, and
these bills placed on the calendar.
The PRESIDING OFFICER. Without
objection, it is so ordered.
The PRESIDING OFFICER. The Sen-
ator from Montana is recognized.
Mr. BURNS. I ask for the regular
order.
f
CONCLUSION OF MORNING
BUSINESS
The PRESIDING OFFICER. Morning
business is closed.
f
DEPARTMENT OF INTERIOR, ENVI-
RONMENT, AND RELATED AGEN-
CIES APPROPRIATIONS ACT, 2006
The PRESIDING OFFICER. Under
the previous order, the Senate will re-
sume consideration of H.R. 2361, which
the clerk will report.
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SPA-136
CONGRESSIONAL RECORDSENATE S7552 June 29, 2005
The journal clerk read as follows:
A bill (H.R. 2361) making appropriations
for the Department of the Interior, Environ-
ment, and Related Agencies for the fiscal
year ending September 30, 2006, and for other
purposes.
Mr. BURNS. Mr. President, I ask
unanimous consent that we proceed to
the regular order.
The PRESIDING OFFICER. Without
objection, it is so ordered.
AMENDMENT NO. 1023
Under the regular order, the Boxer
amendment is now pending. The Sen-
ator from California.
Mrs. BOXER. Mr. President, what is
the order? As I understand it, Senator
BURNS will be offering an amendment,
or has an amendment, and there will be
a vote on my amendment and his side
by side. First, mine; is my under-
standing correct?
Mr. BURNS. That is correct.
Mrs. BOXER. And then his.
The PRESIDING OFFICER. The vote
will be on the Burns amendment first,
followed by the Boxer amendment.
Mrs. BOXER. The time is equally di-
vided an hour a side to debate both
amendments; is that correct?
The PRESIDING OFFICER. That is
correct.
Mrs. BOXER. Mr. President, I ask
unanimous consent that any quorum
calls when placed be divided evenly.
The PRESIDING OFFICER. Without
objection, it is so ordered. The Chair
notes that the Senator from Montana
has not yet called up his amendment.
Mrs. BOXER. I defer to him. I yield
the floor.
Mr. BURNS. Mr. President, we do not
have it yet.
The PRESIDING OFFICER. The
Chair believes that the amendment is
not at the desk yet.
Mr. BURNS. Mr. President, I assure
the Senator from California, I know we
have it somewhere, and I will find it.
Mrs. BOXER. That is reassuring.
Mr. BURNS. That is reassuring; isnt
it? Everybody gets to read itthat is
different in the Senate. We have it.
AMENDMENT NO. 1068
Mr. BURNS. Mr. President, I send an
amendment to the desk.
The PRESIDING OFFICER. The
clerk will report the amendment.
The journal clerk read as follows:
The Senator from Montana [Mr. BURNS],
for himself, Mr. CHAMBLISS, and Mr. INHOFE,
proposes an amendment numbered 1068.
Mr. BURNS. Mr. President, I ask
unanimous consent that the reading of
the amendment be dispensed with.
The PRESIDING OFFICER. Without
objection, it is so ordered.
The amendment is as follows:
(Purpose: To direct the Administrator of the
Environmental Protection Agency to con-
duct a review of all third-party intentional
human dosing studies to identify or quan-
tify toxic effects)
On page 200, after line 2, add the following:
SEC. . ( a) The Administrator of the En-
vironmental Protection Agency shall con-
duct a thorough review of all third-party in-
tentional human dosing studies to identify
or quantify toxic effects currently submitted
to the Agency under FIFRA to ensure that
they:
(1) address a clearly defined regulatory ob-
jective;
(2) address a critical regulatory endpoint
by enhancing the Agencys scientific data
bases;
(3) were designed and being conducted in a
manner that ensured the study was adequate
scientifically to answer the question and en-
sured the safety of volunteers;
(4) was designed to produce societal bene-
fits that outweigh any anticipated risks to
participants;
(5) adhered to all recognized ethical stand-
ards and procedures in place at the time the
study was conducted; and
(6) are consistent with section 12(a)(2)(P) of
the Federal Insecticide, Fungicide, and
Rodenticide Act and all other applicable
laws.
(b) The Administrator shall, within 60 days
of the enactment of this Act, report to the
House and Senate Committees on Appropria-
tions; the Senate Committee on Agriculture,
Nutrition and Forestry; and the House Com-
mittee on Agriculture on the results of the
review required under subsection (a) and any
actions taken pursuant to the review.
(c) Within 180 days of the enactment of this
Act, the Administrator shall issue a final
rule that addresses applying ethical stand-
ards to third party studies involving inten-
tional human dosing to identify or quantify
toxic effects.
The PRESIDING OFFICER. Who
yields time?
Mr. BURNS. Mr. President, I ask
unanimous consent that the amend-
ment be set aside and that the Senator
from California be recognized.
The PRESIDING OFFICER. Without
objection, it is so ordered. The Senator
from California.
AMENDMENT NO. 1023
Mrs. BOXER. Mr. President, is it nec-
essary to now call up amendment No.
1023?
The PRESIDING OFFICER. That
amendment is currently pending.
Mrs. BOXER. Mr. President, I think
we are about to have a very important
debate about a very moral subject
which deals with intentional dosing of
human beings, including children, with
dangerous pesticides. I say this is a
moral issue. As a matter of fact, I be-
lieve I can call my amendment a faith-
based amendment because every major
religious organization in this country
supports my amendment.
My amendment passed the House
without a single dissenting vote. It was
by unanimous consent. I am shocked
and stunned that we even have opposi-
tion to this very simple amendment.
The amendment that was offered by
my good friend, the Senator from Mon-
tana, in my opinion and in the opinion
of people who know about ethics and
science and pesticide testing, it is ac-
tually a very dangerous amendment. It
is offered as, I call it a CY amendment,
cover yourself amendment. You can
vote for his amendment and then
against mine. If you look at his amend-
ment, it is a step back to what is hap-
pening currently. It is a dangerous
amendment because we will push
through a new regulation that already
has been condemned by, as I say, every
major religious organization in this
country.
We will debate this for the next cou-
ple of hours, but I wanted to make a
statement in reaction to the Presi-
dents speech last night.
PRESIDENT BUSHS SPEECH
Mr. President, the President had
every opportunity last night to lay out
his plan for success in Iraq. I had given
a number of interviews where I urged
him to do that, and colleagues on both
sides urged him to do that. Instead,
what we got was a defense of the status
quo and absolutely no mention of the
need to be ready when our troops come
back, 13,000 plus, with horrific injuries,
physical and mentalan opportunity
to say our troops will have everything
they need when they come home and
every bit of equipment they need on
the field in Iraq was blown last night.
And then there was no plan of how we
are going to get out of this thing, and
a continuation of the myth that the
war in Iraq had something to do with
9/11, which it did not.
I looked back yesterday at the De-
partment of State as they looked at
where al-Qaida was on September 11.
Not one al-Qaida cell was in Iraq on
September 11. There were more al-
Qaida cells in my home State of Cali-
fornia.
I am very sorry to see we are on that
status quo and the daily news con-
tinues with the disastrous effects of a
policy that is not geared toward suc-
cess.
AMENDMENT NO. 1023
Mr. President, I am now going to
talk about my amendment. I see the
Senator from Florida is here. At an ap-
propriate moment, I will yield to him.
I want to lay out the general aspects of
my amendment.
The amendment that I offer will sim-
ply say we need to take a timeout in
terms of the environmental protections
action on accepting for review and, in
essence, condoning pesticide testing on
human beings. We need a timeout.
Christy Todd Whitman thought we
needed a moratorium. She put one in
place. Carol Browner, under President
Clinton, put a moratorium in place.
But now the moratorium has lapsed
and, shockingly, EPA is considering
and encouraging intentional dosing of
human beings with dangerous pes-
ticides. This is not rhetoric. I am going
to show the charts and show the ex-
periments.
What my friend and colleague is of-
fering is a figleaf cover amendment:
Dont vote for Boxer, it actually does
something; vote for the Burns amend-
ment whichlisten to what it does
speeds up a regulation that is already
going through EPA that is downright
dangerous and involves testing of
human beings, including newborn ba-
biesvery ill newborn babiespreg-
nant women, and fetuses. That is why
every major religious organization in
America has entered on the side of the
Boxer amendment and opposed to the
Burns amendment.
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CONGRESSIONAL RECORDSENATE S7553 June 29, 2005
I am going to show the actual lan-
guage of the Boxer amendment. It is
exactly the language of the House-
passed amendment:
None of the funds made available in this
Act may be used by the Administrator of the
Environmental Protection Agency to
(1) accept, consider, or rely on third-party
intentional dosing human studies for pes-
ticides; or
(2) to conduct intentional dosing human
studies for pesticides.
It is simply a straightforward timeout so
that we can look at the ethical, moral, and
health issues surrounding the current policy
at the EPA.
As I said, Carol Browner, a Demo-
crat, put that moratorium in place;
Christy Todd Whitman, a Republican,
put that moratorium in place. But now
it has been allowed to lapse.
I recently released a staff report with
Congressman WAXMAN that reviewed 22
of the studies that EPA is currently
looking at. I want to tell you what we
found after reviewing these studies.
We found that human testing of pes-
ticide moratorium was allowed to lapse
by the EPA; that over 20 human dosing
studies are currently being reviewed by
the EPA; and that the studiesand
this is the most important point, Mr.
Presidentthe studies routinely vio-
late ethical and scientific standards
laid out in the Nuremberg Code, the
Declaration of Helsinki, the Common
Rule, and the National Academy of
Sciences recommendations on human
testing. In other words, we have noth-
ing in place that would guide these ex-
periments.
I am going to show you one of these
experiments that is being reviewed by
the EPA. So lets go to the UC San
Diego study.
I care a lot about this because this
happened in my State.
This is a study on chloropicrin. What
is chloropicrin? It is a fumigant. It is
an active ingredient in tear gas, and it
was a chemical warfare agent in World
War I.
I told you about chloropicrin. In the
material safety data sheet which is put
out by the manufacturer, this is what
it says about chloropicrin which was
given to UC San Diego students, and I
will talk about the dose they received.
Warning statements and warning
properties, this is what it says:
Danger. May be fatal if inhaled or swal-
lowed. Severe burn follows liquid contact
with eyes or skin. May cause severe res-
piratory tract irritation. Causes eye and
skin irritation. Lachrymator
This means it is the tear gas prop-
erty
poison may cause lung damage.
Chloropicrin was categorized as a
category 1, which is the most toxic due
to acute lethality and severe irritation.
Lets look at how the students got
these doses. They were paid $15 an
hour. They were told that this was not
dangerous. They signed liability waiv-
ers. This is all unethical, and nothing
in the Burns amendment will stop any
of this and nothing in the Burns
amendment addresses these issues.
Here we can see the students receiv-
ing this dangerous fumigant through
this hose and breathing it in. This is
right from the study:
Figure 10. Showing subjects sampling from
two cones through yokes that directed flow
from the right cone into the right nostril
and from the left cone into the left nostril.
The subjects needed to decide whether they
felt the chloropicrin on the right or the left.
Do you want your daughter breathing
in this dangerous chemical at doses
that are very large, which I will ex-
plain?
This is a picture of a young woman
taking part in an experiment where the
chloropicrin dose was up to 1.2 parts
per million. I want you to remember 1.2
parts per million because this is the
point. The workplace safety standard
for chloropicrin is .1 parts per million.
This experiment dosed these kids with
12 times higher than the average level
allowed in the workplace.
Let me repeat that. This experiment
dosed these students with 12 times the
level that is considered safe. And this
is a recent experiment. It ended in De-
cember of 2004.
I am going to show you what OSHA
says you should wear when you are ex-
posed to chloropicrin at levels higher
than .1, 12 times lower than these stu-
dents were dosed with. It requires a
full-face plate respirator or powered air
purifying respirator with organic car-
tridge to protect from the chemical,
according to the manufacturer.
I have to say, what more of a moral
issue can we be facing than allowing
these students to have chloropicrin
pumped through their nostrils at a rate
12 times higher than the safety level
that OSHA, our Federal Government,
says is safe? What right do we have to
allow that to go on? Yet the Burns
amendment will allow it to go on.
The only way to stop it is with the
Boxer amendment, which is the iden-
tical amendment to the House amend-
ment where not even TOM DELAY, who
comes from the pesticide industry, reg-
istered a no vote.
How can we in the Senate, the most
deliberative body in the land, walk
away from a simple moratorium on
this kind of situation?
Let us look at the next chart. This
next chart shows the 20 studies under
review since the moratorium was al-
lowed to lapse. I could not even pro-
nounce all of these properly, but I will
give a few of them. Carbofuran,
ethephon, amitraz, methomyl, oxamyl,
malathion, and chloropicrin was the
top one.
It also shows the dates. These are all
studies similar to this one. Actually, in
one study did they not have to swallow
pesticide pills for breakfast? That is a
fact.
Because I am a member of the Envi-
ronment and Public Works Committee,
as a result of that membership we de-
manded to see all of these studies.
They were being kept from the public
and we now know these things are
going on.
In some studies subjects were
harmedfor example, experiencing
heart arrhythmias; that is, an uneven
heartbeat, a racing heart, and we now
know it was a result of that chemical
that was being used. Many of the stud-
ies had very misleading consent forms.
Some described the pesticide as a drug.
In some studies adverse outcomes were
dismissed. They said, oh, they went to
the hospital because they did not feel
good, but it had nothing to do with the
dosing of the pesticide. Hard to believe.
Most of the studies had no long-term
monitoring reviews and few were large
enough to be statistically valid. The
deficiencies are significant and wide-
spread and that is why we need this
moratorium on this timeout to allow a
set of standards to be developed that
governs the use of these studies. The
development of sound standards is crit-
ical, if the problems with human pes-
ticide testing are to be addressed.
At this point, I yield 8 minutes to the
Senator from Florida.
The PRESIDING OFFICER. The Sen-
ator from Florida.
Mr. NELSON of Florida. Mr. Presi-
dent, I am delighted to join my col-
league from California. We have fought
these battles before. We fought one of
these battles when unbelievably the
EPA wanted to conduct an experiment.
They called it a study. It was a 2-year
study they were going to perform on
infants in my State in Jacksonville,
FL. This 2-year study was going to ex-
pose those infants to pesticides. It was
going to be done with the inducement
by getting the parents of the infants to
sign a contract of which over a 2-year
period they were going to be paid $970,
were going to be given a T-shirt, were
going to be given other kinds of trin-
kets, and a certificate of appreciation
in return for children over that 2-year
period being exposed to pesticides that
were going to be placed in the home.
Oh, by the way, guess which part of
town this was going to occur in. You
guessed it. It was going to occur in the
lower income and minority sections of
Jacksonville.
Senator BOXER and I got wind of it.
Well, she got wind of it because she was
sitting on the committee having to do
with the confirmation of the head of
EPA and she announced that, in fact,
she was not going to let the EPA nomi-
nee go through. Then she came to me
and pointed out that, in fact, this was
occurring in Florida.
This was one of the brochures, if my
colleagues can believe it, that EPA was
going to send out. As a matter of fact,
they had already sent it out in Jack-
sonville. They had gotten some 30 par-
ents to already sign up for this pro-
gram. It states: Youre a parent. Learn
more about your childs potential pes-
ticide exposure. Am I eligible to par-
ticipate? Only 60 participants will be
selected. To be selected, you must be a
parent of a child less than 3 months old
or one between the ages of 9 and 12
months old.
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CONGRESSIONAL RECORDSENATE S7554 June 29, 2005
Get this, in order to be eligible, one
has to spray or have pesticides sprayed
inside their home routinely.
The ad states: Will I be compensated?
Oh, of course. You will receive up to
$970 over the 2-year period. Your family
will receive an official framed certifi-
cate of appreciation, a CHEERS bib for
your baby, a T-shirt, a calendar, and a
study newsletter. You will be allowed
to keep the video camcorder they are
going to give to you to record this
study over the 2 years. You will be al-
lowed to keep the video camcorder at
the end of the study provided you have
completed all of the study activities.
Can anyone believe this is going on
in the United States of America in the
year 2005?
Well, we put a stop to it because Sen-
ator BOXER put a hold on the nominee.
I put a hold on the nominee. I had a
conversation with the nominee and I
told the nominee I had no objection to
the nominee. As a matter of fact, I had
heard awfully good things about the
nominee. But as a Senator from Flor-
ida, I certainly was not going to let
that sort of thing go on in my State
and it should not be going on in any
State. All I wanted the nominee to do
was to cancel that study.
What they did not tell the local
Jacksonville Health Department was
that of the $9 million the study was
going to cost, $2 million of the $9 mil-
lion was being supplied by the pesticide
industry. Needless to say, the Duval
County Health Department did not like
it when they found that out.
This is the kind of stuff we have had
to go through with regard to human
testing and it just should not be. So it
is time to put it in this bill. This is un-
like pharmaceutical studies on humans
that offer the possibility that a human
subject may benefit from the experi-
ment. The human testing of pesticides
offers no therapeutic benefit, and under
this proposed rule EPA would be al-
lowed to test on humans, children,
pregnant women, newborns, and in-
fants.
This senior Senator from Florida has
had a bellyful of this kind of stuff to
come in on the citizens of the State of
Florida, and I want it stopped. Any ex-
posure of an infant child or a pregnant
woman to a toxin basically should be
prohibited, even in doses that are not
expected to do any harm.
With the experience I have had in
Jacksonville, it was simply irrespon-
sible for the EPA, whose very mission
is to protect human health and the en-
vironment, to have proposed such a
study. The last time I checked, I
thought EPA stood for Environmental
Protection Agency. Well, then it needs
to fulfill its challenge. It needs to ful-
fill the goal of its name.
The happy ending to the story in
Jacksonville was that we stopped it be-
cause the nominee for the head of the
EPA cancelled the study. Senator
BOXER and I lifted our hold and we send
our great wishes to the new adminis-
trator of the EPA for a successful ad-
ministration.
We need to help the administrator of
EPA have a successful administration
and we can do this with the Boxer-Nel-
son amendment.
I yield the floor.
Mrs. BOXER. Would the Senator
please yield back his extra time to me?
Mr. NELSON of Florida. I certainly
will.
Mrs. BOXER. I thank the Senator
from Florida. He is a protector of chil-
dren, families, and the vulnerable of
his State. His help on that CHEERS
program and getting that stopped was
an enormous contribution. Many times
we do big things around here that deal
with huge issues and we do not know
the impact of our work for a long time.
When one works for clean air, clean
water, it takes a while.
I say to my friend from Florida, this
is something he can be proud of be-
cause we together, as a team, with the
help of some of our colleagues on the
Environment and Public Works Com-
mittee, were able to use the leverage
each Senator has to force a cancella-
tion of a program that was inten-
tionally dosing little children with pes-
ticides, paying off their parents who
tended to be poor, giving the parents a
video camera, and subjecting these
children to dangerous chemicals. So I
think we have to be proud that we
saved some kids from this.
I want to say why my amendment is
so crucial and why the Burns amend-
ment is so bad if one cares about pro-
tecting children and families. The
amendment I have offered with my col-
league from Floridaand, by the way,
I ask unanimous consent that the fol-
lowing Senators be added as cosponsors
to this amendment: Senators SNOWE,
COLLINS, NELSON of Florida, CLINTON,
SCHUMER, OBAMA, JEFFORDS, KERRY,
LAUTENBERG, REID, and LEVIN.
The PRESIDING OFFICER. Without
objection, it is so ordered.
Mrs. BOXER. I think my colleagues
can see this is a bipartisan amendment.
We want to protect our children. This
has nothing to do with politics. We
want to protect our families.
Here is what is happening. The Burns
substitute, which he is going to try to
tell everyone is better than the mora-
torium, essentially encourages the
EPA to continue with their rule-
making. It says, go on, hurry, finish it
up, and it does nothing to stop any of
the testing that is going on right now.
So it is a step back. It is a dangerous
step back.
Now, why do I say that? I will tell my
colleagues about the EPA rule that is
coming at us if we do not stop this.
This is straight from the EPA. We are
fortunate enough to have this informa-
tion today.
The Agency has decided not to include any
proposed requirements relating to a Human
Studies Review Board as suggested in the
National Academy of Sciences recommenda-
tion 62.
The National Academy of Sciences
we looked for it so that we have ethical
guidelines. The EPA has rejected the
guidelines of the National Academy of
Sciences and the Burns amendment
says, oh, go right ahead, EPA, finish
your regulations, and the Burns
amendment makes no reference to the
NAS. This is more from the EPA:
The promulgation of rules prescribing such
details [establishment of the Human Studies
Review Board] would unnecessarily confine
EPAs discretion . . .
So, in other words, they are admit-
ting they are turning away the guide-
lines of the National Academy of
Sciences because they do not want to
be confined in doing what they do.
What do they want to do? When you
find that out you will be rather
shocked. Are you ready for this? I say
to my friend from Montana, if this
doesnt shake his confidence in his
amendment, nothing will. This is a
bombshell that I am about to tell you.
The EPA is considering continuing a
limited number of scientific studies in-
volving pregnant womenmeaning
they will be dosed with pesticides,
fetusesmeaning fetuses will be dosed
with pesticides, neonates of uncertain
viabilityand just for those of you who
do not know, neonates are newborn ba-
biesof uncertain viabilitymeaning
they are ill; sick babies will be in these
experiments, or nonviable neonates
meaning newborns who may not make
it. They are going to dose them as well.
If we cant take a stand to protect
the sickest of the newborn babies, then
we dont deserve to be here. If we are
going to stand with the pesticide com-
panies against ill, very ill newborn ba-
bies, what are we doing here? We dont
belong here.
Lets see what some of the religious
groups are saying. For those people
who want to have faith-based legisla-
tion, you are on the faith-based legisla-
tion when you support the Boxer-
Snowe-Nelson-Clinton-Collins, et
cetera amendment. This is the state-
ment of the Leadership of Diverse
Faith Groups on human testing. It is
signed by the National Council of
Churches and the Coalition on the En-
vironment and Jewish Life.
Our faiths teach us to protect the vulner-
able among us and to do so we need a mora-
torium on the use of human testing data in
the registration of pesticides, not another
study or report.
The Burns alternative is another
study. But worse than that, the Burns
amendment encourages and orders the
EPA to get their regulations in place,
regulations that, as I told you, allow
testing on newborn babies and fetuses
and pregnant women and desperately
ill newborns. Why are we having a de-
bate? Why arent we all supporting a
moratorium, a timeout, just as
Christie Todd Whitman did, just as
Carol Browner did? This is a bipartisan
effort.
Unfortunately, we have to choose. In-
stead of walking down this aisle to-
gether and saying we will not allow
testing on pregnant womencan you
imagine testing pesticides on des-
perately ill newborn babies and testing
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CONGRESSIONAL RECORDSENATE S7555 June 29, 2005
pesticides on fetuses? I just cant imag-
ine that that is what we are going to do
today by voting on the Burns amend-
ment and telling EPA to hurry up with
their regulations instead of taking a
timeout.
Lets look at some of the churches
that are involved in supporting the
Boxer amendment. Lets take a look at
the list of these churches and these re-
ligious organizations. I will just read
some of them: The African Methodist
Episcopal Church; the Alliance of Bap-
tists; Archdiocese of America; the Dio-
cese of the Armenian Church; Christian
Church (Disciple of Christ); the Church
of the Brethren; the Coptic Church; the
Evangelical Lutheran Church; Friends
United Meeting; Greek Orthodox Arch-
diocese of America; International
Council of Community Churches; Ko-
rean Presbyterian Church; Moravian
Church in America, Northern Province
and Southern Province; National Bap-
tist Convention of America; National
Baptist Convention, USA; Orthodox
Church in America; Polish National
Catholic Church of America; Progres-
sive National Baptist Convention; Syr-
ian Orthodox Church of Antioch;
Ukrainian Orthodox Church of the
United States of America; United
Church of Christ; The United Meth-
odist Church.
It goes on.
The reason I am reading this is this
is very unusual to see a faith-based
amendment that deals with morality,
to have so many of our religious lead-
ers supporting us and opposing the
Burns amendment. Why do we even
have a debate? Certain things are right
and certain things are wrong. Yes, it is
an issue of social justice. Who is going
to step up to the plate and offer up
their newborn baby?
Lets take a look at that again, the
statement about testing on newborns. I
think Senator DURBIN is interested in
this and said he wanted to ask a ques-
tion about it. The fact is, all of the re-
ligious organizations have stepped up
to the plate, in part, because of this.
This is EPAs own words.
EPA thinks it likely that it will continue
a limited number of scientific studies involv-
ing pregnant women, fetuses, neonates
[meaning newborns] of uncertain viability,
or non-viable neonates [in other words, des-
perately ill babies] in the future.
It is hard to imagine how anyone in
the Senate could vote for an alter-
native which encourages the EPA to
hurry up and produce their regulation,
when we can all come together as ev-
eryone did in the House of Representa-
tives and say: Time out, EPA. This is a
moral issue.
Mr. DURBIN. Will the Senator from
California yield for a question?
Mrs. BOXER. I will.
Mr. DURBIN. I direct the question
through the Chair. Those tuning in to
this debate and starting to listen may
not grasp what is at issue. The way you
described it to us yesterday in the Sen-
ate Democratic caucus luncheon was
that the Environmental Protection
Agency is testing the toxicity, or poi-
sonous nature, of pesticides on human
beings here in the United States. Since
this came to the attention of the House
of Representatives, they have said this
is wrong; we dont want to endanger
anyones life by testing them with pes-
ticides, particularly children, pregnant
women, othersfor that matter, any
person. So they decided to suspend, as
I understand it, the authority of the
EPA to go forward with this testing.
An argument is being made on the
floor today, by those opposing your
amendment, that we should go ahead
and continue the testing? Is that what
is at issue?
Mrs. BOXER. That is the essence.
You can put lipstick on it but essen-
tially the opposition is saying no to
the Boxer amendment, and lets just
tell the EPA to look at ethical guide-
lines and consider them and hurry up
and issue a regulation.
Does it make any reference to the
National Academy of Sciences, which
has very strict regulations? It doesnt
make any reference to any of the
guidelines that are internationally rec-
ognized. So, in essence, the Burns
amendment is the status quo with a
kicker that we continue these studies
and that, in essence, we say to the
EPA: Hurry up with your regulation.
Mr. DURBIN. If the Senator will fur-
ther yield for a question through the
Chair, the photograph she displayed is
the same one she brought before us
yesterday. It depicts two young people,
a man and woman, who are involved in
some testing where they are inhaling
pesticides to determine what the phys-
ical impact would be if they have a cer-
tain amount of pesticide in their sys-
tem. Are you saying the Federal Gov-
ernment is paying for this research,
and is paying these people to come for-
ward and submit to this testing?
Mrs. BOXER. This test is being paid
for by the pesticide maker, who wants
to say that they should be allowed to
use more chloropicrin in their pes-
ticide. They have paid the University
of San Diego to do this.
The EPA accepted that study. In
other words, they are saying fine, we
are going to look at the results of that
study.
It was Ronald Reagan who put a stop
to looking at the tests that came out
of World War II. Because after World
War II, we saw what was going on with
medical studies. Ronald Reagan was
the one who said we are going to stop
this. We are not going to even look at
these studies because they are im-
moral.
What we are saying today is, it is im-
moral to take a young woman like
thisand tell her, by the way, she is
not going to be harmedmake her sign
a waiver of liability so she cannot real-
ly recover if she is sick, pay her $15 an
hour because she is a student and prob-
ably needs the money desperately, and
not tell her what this other picture
shows, the man in the mask, that she is
breathing chloropicrin at a rate 12
times the rate that our Federal Gov-
ernment, our OSHA says is dangerous.
If you were to have a concentration
of this chemical 12 times less than
what these kids are getting into their
nostrils, into their lungs, you need to
wear this type of full-face plate res-
pirator or powered air purifying res-
pirator with organic cartridge to pro-
tect from the chemicals.
Mr. DURBIN. How long has this been
going on?
Mrs. BOXER. That is the interesting
question. Under Bill Clintons adminis-
tration, in the late 1990s, Carol Brown-
er, the Administrator of EPA, stopped
this kind of acceptance of these tests
by the EPA.
Christie Todd Whitman agreed with
her and stopped all of this and said
EPA is not goi