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53440 Federal Register / Vol. 72, No.

181 / Wednesday, September 19, 2007 / Rules and Regulations

follows: Artichoke, globe from 0.05 ppm the requirements of the Regulatory Dated: September 7, 2007.
to 0.1 ppm; asparagus from 0.1 ppm to Flexibility Act (RFA) (5 U.S.C. 601 et Lois Rossi,
0.15 ppm; brassica head and stem, seq.) do not apply. Director, Registration Division, Office of
subgroup 5-A from 0.05 ppm to 0.1 This final rule directly regulates Pesticide Programs.
ppm; and grape from 0.05 ppm to 0.1 growers, food processors, food handlers, ■Therefore, 40 CFR chapter I is
ppm. and food retailers, not States or tribes, amended as follows:
The tolerances for artichoke, globe;
nor does this action alter the
brassica head and stem, subgroup 5-A; PART 180—[AMENDED]
relationships or distribution of power
and grape were determined based on the
and responsibilities established by ■ 1. The authority citation for part 180
sum of the method Limits of
Quantitation (LOQ) for parent Congress in the preemption provisions continues to read as follows:
pendimethalin (0.05 ppm) and its of section 408(n)(4) of FFDCA. As such,
Authority: 21 U.S.C. 321(q), 346a and 371.
regulated metabolite (0.05 ppm), since the Agency has determined that this
action will not have a substantial direct ■ 2. Section 180.361 is amended by
no detectable residues were found in the alphabetically adding the following
submitted residue field trials. effect on States or tribal governments,
on the relationship between the national commodities to the table in paragraph
The tolerance for asparagus was (a) to read as follows:
determined using the Agency’s government and the States or tribal
Tolerance Spreadsheet in accordance governments, or on the distribution of 180.361 Pendimethalin; tolerances for
with the Agency’s Guidance for Setting power and responsibilities among the residues.
Pesticide Tolerances Based on Field various levels of government or between (a) * * *
Trial Data. the Federal Government and Indian
Therefore, tolerances are established tribes. Thus, the Agency has determined Parts per
Commodity
for combined residues of that Executive Order 13132, entitled million
pendimethalin, N-(1-ethylpropyl)-3,4- Federalism (64 FR 43255, August 10,
dimethyl-2,6-dinitrobenzenamine, and 1999) and Executive Order 13175, * * * * *
its metabolite, 4-[(1-ethylpropyl)amino]- entitled Consultation and Coordination Artichoke, globe ........................ 0.1
Asparagus ................................. 0.15
2-methyl-3,5-dinitrobenzyl alcohol, in with Indian Tribal Governments (65 FR * * * * *
or on artichoke, globe at 0.1 ppm; 67249, November 6, 2000) do not apply Brassica head and stem, sub-
asparagus at 0.15 ppm; brassica head to this rule. In addition, This rule does group 5-A .............................. 0.1
and stem, subgroup 5-A at 0.1 ppm; and not impose any enforceable duty or * * * * *
grape at 0.1 ppm. contain any unfunded mandate as Grape ........................................ 0.1
described under Title II of the Unfunded * * * * *
VI. Statutory and Executive Order
Reviews Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4). [FR Doc. E7–18259 Filed 9–18–07; 8:45 am]
This final rule establishes a tolerance BILLING CODE 6560–50–S
under section 408(d) of FFDCA in This action does not involve any
response to a petition submitted to the technical standards that would require
Agency. The Office of Management and Agency consideration of voluntary ENVIRONMENTAL PROTECTION
Budget (OMB) has exempted these types consensus standards pursuant to section AGENCY
of actions from review under Executive 12(d) of the National Technology
Order 12866, entitled Regulatory Transfer and Advancement Act of 1995 40 CFR Part 180
Planning and Review (58 FR 51735, (NTTAA), Public Law 104–113, section
[EPA–HQ–OPP–2007–0539; FRL–8147–3]
October 4, 1993). Because this rule has 12(d) (15 U.S.C. 272 note).
been exempted from review under VII. Congressional Review Act Trifloxystrobin; Pesticide Tolerance
Executive Order 12866, this rule is not
subject to Executive Order 13211, The Congressional Review Act, 5 AGENCY: Environmental Protection
Actions Concerning Regulations That Agency (EPA).
U.S.C. 801 et seq., generally provides
Significantly Affect Energy Supply, that before a rule may take effect, the ACTION: Final rule.
Distribution, or Use (66 FR 28355, May agency promulgating the rule must SUMMARY: This regulation establishes a
22, 2001) or Executive Order 13045, submit a rule report to each House of tolerance for combined residues of
entitled Protection of Children from the Congress and to the Comptroller Trifloxystrobin and the acid metabolite
Environmental Health Risks and Safety General of the United States. EPA will CGA–321113 in or on grass, forage and
Risks (62 FR 19885, April 23, 1997). submit a report containing this rule and grass, hay. Bayer CropScience requested
This final rule does not contain any other required information to the U.S. this tolerance under the Federal Food,
information collections subject to OMB Senate, the U.S. House of Drug, and Cosmetic Act (FFDCA).
approval under the Paperwork Representatives, and the Comptroller
Reduction Act (PRA), 44 U.S.C. 3501 et DATES: This regulation is effective
General of the United States prior to
seq., nor does it require any special September 19, 2007. Objections and
publication of this final rule in the
considerations under Executive Order requests for hearings must be received
Federal Register. This final rule is not
12898, entitled Federal Actions to on or before November 19, 2007, and
a ‘‘major rule’’ as defined by 5 U.S.C.
Address Environmental Justice in must be filed in accordance with the
804(2).
Minority Populations and Low-Income instructions provided in 40 CFR part
Populations (59 FR 7629, February 16, 178 (see also Unit I.C. of the
List of Subjects in 40 CFR Part 180
1994). SUPPLEMENTARY INFORMATION).
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Since tolerances and exemptions that Environmental protection, ADDRESSES: EPA has established a
are established on the basis of a petition Administrative practice and procedure, docket for this action under docket
under section 408(d) of FFDCA, such as Agricultural commodities, Pesticides identification (ID) number EPA–HQ–
the tolerance in this final rule, do not and pests, Reporting and recordkeeping OPP–2007–0539. To access the
require the issuance of a proposed rule, requirements. electronic docket, go to http://

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Federal Register / Vol. 72, No. 181 / Wednesday, September 19, 2007 / Rules and Regulations 53441

www.regulations.gov, select ‘‘Advanced affected by this action. Other types of • Delivery: OPP Regulatory Public
Search,’’ then ‘‘Docket Search.’’ Insert entities not listed in this unit could also Docket (7502P), Environmental
the docket ID number where indicated be affected. The North American Protection Agency, Rm. S–4400, One
and select the ‘‘Submit’’ button. Follow Industrial Classification System Potomac Yard (South Bldg.), 2777 S.
the instructions on the regulations.gov (NAICS) codes have been provided to Crystal Dr., Arlington, VA. Deliveries
website to view the docket index or assist you and others in determining are only accepted during the Docket’s
access available documents. All whether this action might apply to normal hours of operation (8:30 a.m. to
documents in the docket are listed in certain entities. If you have any 4 p.m., Monday through Friday,
the docket index available in questions regarding the applicability of excluding legal holidays). Special
regulations.gov. Although listed in the this action to a particular entity, consult arrangements should be made for
index, some information is not publicly the person listed under FOR FURTHER deliveries of boxed information. The
available, e.g., Confidential Business INFORMATION CONTACT. Docket Facility telephone number is
Information (CBI) or other information (703) 305–5805.
B. How Can I Access Electronic Copies
whose disclosure is restricted by statute.
of this Document? II. Petition for Tolerance
Certain other material, such as
copyrighted material, is not placed on In addition to accessing an electronic In the Federal Register of August 1,
the Internet and will be publicly copy of this Federal Register document 2007 (72 FR 42072) (FRL–8138–1), EPA
available only in hard copy form. through the electronic docket at http:// issued a notice pursuant to section
Publicly available docket materials are www.regulations.gov, you may access 408(d)(3) of the FFDCA, 21 U.S.C.
available in the electronic docket at this Federal Register document 346a(d)(3), announcing the filing of a
http://www.regulations.gov, or, if only electronically through the EPA Internet pesticide petition (PP 6F7024) by Bayer
available in hard copy, at the OPP under the ‘‘Federal Register’’ listings at CropScience, P.O. Box 12014, 2 T.W.
Regulatory Public Docket in Rm. S– http://www.epa.gov/fedrgstr. You may Alexander Dr., Research Triangle Park,
4400, One Potomac Yard (South Bldg.), also access a frequently updated NC 27709. The petition requested that
2777 S. Crystal Dr., Arlington, VA. The electronic version of EPA’s tolerance 40 CFR 180.555 be amended by
Docket Facility is open from 8:30 a.m. regulations at 40 CFR part 180 through establishing a tolerance for combined
to 4 p.m., Monday through Friday, the Government Printing Office’s pilot residues of the fungicide
excluding legal holidays. The Docket e-CFR site at http://www.gpoaccess.gov/ Trifloxystrobin, (benzeneacetic acid,
Facility telephone number is (703) 305– ecfr. (E,E)-a-(methoxyimino)-2-[[[[1-[3-
5805. (trifluoromethyl)
C. Can I File an Objection or Hearing phenyl]ethylidene]amino]oxy] methyl]-
FOR FURTHER INFORMATION CONTACT: Request? methyl ester) and the free form of its
Janet Whitehurst, Registration Division Under section 408(g) of the FFDCA, acid metabolite CGA–321113 (E,E)-
(7505P), Office of Pesticide Programs, any person may file an objection to any methoxyimino-[2-[1-(3-
Environmental Protection Agency, 1200 aspect of this regulation and may also trifluoromethylphenyl)-
Pennsylvania Ave., NW., Washington, request a hearing on those objections. ethylideneaminooxymethyl]-phenyl]
DC 20460–0001; telephone number: You must file your objection or request acetic acid, in or on grass, forage at 10
(703) 305–6129; e-mail address: a hearing on this regulation in parts per million (ppm) and grass, hay
whitehurst.janet@epa.gov. accordance with the instructions at 14 ppm. That notice referenced a
SUPPLEMENTARY INFORMATION: provided in 40 CFR part 178. To ensure summary of the petition prepared by
I. General Information proper receipt by EPA, you must Bayer CropScience, the registrant,
identify docket ID number EPA–HQ– which is available to the public in the
A. Does this Action Apply to Me? OPP–2007–0539 in the subject line on docket, http://www.regulations.gov.
You may be potentially affected by the first page of your submission. All Comments were received on the notice
this action if you are an agricultural requests must be in writing, and must be of filing. EPA’s response to these
producer, food manufacturer, or mailed or delivered to the Hearing Clerk comments is discussed in Unit IV.C.
pesticide manufacturer. Potentially as required by 40 CFR part 178 on or below.
affected entities may include, but are before November 19, 2007. Based upon review of the data
not limited to those engaged in the In addition to filing an objection or supporting the petition, EPA has
following activities: hearing request with the Hearing Clerk modified the tolerances proposed for
• Crop production (NAICS code 111), as described in 40 CFR part 178, please grass, forage and grass, hay. The
e.g., agricultural workers; greenhouse, submit a copy of the filing that does not appropriate tolerances for grass forage
nursery, and floriculture workers; contain any CBI for inclusion in the and hay were calculated to be 12 and 17
farmers. public docket that is described in ppm, respectively. Although residue
• Animal production (NAICS code ADDRESSES. Information not marked data were also provided for grass straw
112), e.g., cattle ranchers and farmers, confidential pursuant to 40 CFR part 2 and seed screenings, tolerances are not
dairy cattle farmers, livestock farmers. may be disclosed publicly by EPA required on these commodities as the
• Food manufacturing (NAICS code without prior notice. Submit this copy, Agency no longer considers them to be
311), e.g., agricultural workers; farmers; identified by docket ID number EPA– significant livestock feedstuffs. The
greenhouse, nursery, and floriculture HQ–OPP–2007–0539, by one of the recommended tolerance levels for grass
workers; ranchers; pesticide applicators. following methods: forage and hay were determined
• Pesticide manufacturing (NAICS • Federal eRulemaking Portal: http:// considering recent Agency Guidance
code 32532), e.g., agricultural workers; www.regulations.gov. Follow the on-line (Guidance for Setting Pesticide
commercial applicators; farmers; instructions for submitting comments. Tolerances Based on Field Trial Data).
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greenhouse, nursery, and floriculture • Mail: Office of Pesticide Programs


workers; residential users. (OPP) Regulatory Public Docket (7502P), III. Aggregate Risk Assessment and
This listing is not intended to be Environmental Protection Agency, 1200 Determination of Safety
exhaustive, but rather to provide a guide Pennsylvania Ave., NW., Washington, Section 408(b)(2)(A)(i) of the FFDCA
for readers regarding entities likely to be DC 20460–0001. allows EPA to establish a tolerance (the

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53442 Federal Register / Vol. 72, No. 181 / Wednesday, September 19, 2007 / Rules and Regulations

legal limit for a pesticide chemical can be found in the Trifloxystrobin: in docket ID number EPA–HQ–OPP–
residue in or on a food) only if EPA Human Health Risk Assessment for 2007–0539.
determines that the tolerance is ‘‘safe.’’ Section 3 Registration for the Proposed
C. Exposure Assessment
Section 408(b)(2)(A)(ii) of FFDCA Uses on Grasses Grown for Seed. at
defines ‘‘safe’’ to mean that ‘‘there is a http://www.regulations.gov. The 1. Dietary exposure from food and
reasonable certainty that no harm will referenced document is available in the feed uses. In evaluating dietary
result from aggregate exposure to the docket established by this action, which exposure to Trifloxystrobin, EPA
pesticide chemical residue, including is described under ADDRESSES, and is considered exposure under the
all anticipated dietary exposures and all identified as EPA–HQ–OPP–2007–0539 petitioned-for tolerances as well as all
other exposures for which there is in that docket. existing Trifloxystrobin tolerances in
reliable information.’’ This includes (40 CFR 180.555). EPA assessed dietary
B. Toxicological Endpoints exposures from Trifloxystrobin in food
exposure through drinking water and in
residential settings, but does not include For hazards that have a threshold as follows:
occupational exposure. Section below which there is no appreciable i. Acute exposure. Quantitative acute
408(b)(2)(C) of the FFDCA requires EPA risk, the toxicological level of concern dietary exposure and risk assessments
to give special consideration to (LOC) is derived from the highest dose are performed for a food-use pesticide,
exposure of infants and children to the at which no adverse effects are observed if a toxicological study has indicated the
pesticide chemical residue in (the NOAEL) in the toxicology study possibility of an effect of concern
establishing a tolerance and to ‘‘ensure identified as appropriate for use in risk occurring as a result of a 1–day or single
that there is a reasonable certainty that assessment. However, if a NOAEL exposure.
no harm will result to infants and cannot be determined, the lowest dose In estimating acute dietary exposure,
children from aggregate exposure to the at which adverse effects of concern are EPA used food consumption
pesticide chemical residue....’’ These identified (the LOAEL) is sometimes information from the U.S. Department of
provisions were added to the FFDCA by used for risk assessment. Uncertainty/ Agriculture (USDA) 1994–1996 and
the Food Quality Protection Act (FQPA) safety factors (UFs) are used in 1998 Nationwide Continuing Surveys of
of 1996. conjunction with the LOC to take into Food Intake by Individuals (CSFII). As
Consistent with FFDCA section account uncertainties inherent in the to residue levels in food, EPA assumed
408(b)(2)(D), and the factors specified in extrapolation from laboratory animal 100% crop treated (CT) and tolerance
FFDCA section 408(b)(2)(D), EPA has data to humans and in the variations in level residues for each commodity.
reviewed the available scientific data sensitivity among members of the ii. Chronic exposure. In conducting
and other relevant information in human population as well as other the chronic dietary exposure assessment
support of this action. EPA has unknowns. Safety is assessed for acute EPA used the food consumption data
sufficient data to assess the hazards of and chronic risks by comparing from the USDA 1994–1996 and 1998
and to make a determination on aggregate exposure to the pesticide to CSFII. As to residue levels in food, EPA
aggregate exposure for the petitioned-for the acute population adjusted dose assumed 100% CT and tolerance level
tolerance for combined residues of (aPAD) and chronic population adjusted residues for each commodity.
Trifloxystrobin, (benzeneacetic acid, dose (cPAD). The aPAD and cPAD are iii. Cancer. The Agency classified
(E,E)-a-(methoxyimino)-2-[[[[1-[3- calculated by dividing the LOC by all trifloxystrobin as a ‘‘not likely
(trifluoromethyl) applicable UFs. Short-term, carcinogen;’’ therefore, quantification of
phenyl]ethylidene]amino]oxy] methyl]- intermediate-term, and long-term risks human cancer risk is not required and
methyl ester) and the free form of its are evaluated by comparing aggregate a cancer dietary assessment was not
acid metabolite CGA–321113 (E,E)- exposure to the LOC to ensure that the performed.
methoxyimino-[2-[1-(3- margin of exposure (MOE) called for by iv. Anticipated residue and percent
trifluoromethylphenyl)- the product of all applicable UFs is not crop treated (PCT) information. The
ethylideneaminooxymethyl]-phenyl] exceeded. Agency did not use anticipated residue
acetic acid (hereinafter referrred to as For non-threshold risks, the Agency estimates or PCT information in the
Trifloxsytrobin) on grass, forage at 12 assumes that any amount of exposure trifloxystrobin dietary exposure
ppm and grass, hay at 17 ppm. EPA’s will lead to some degree of risk and assessment.
assessment of exposures and risks estimates risk in terms of the probability 2. Dietary exposure from drinking
associated with establishing the of occurrence of additional adverse water. The Agency lacks sufficient
tolerance follows. cases. Generally, cancer risks are monitoring data to complete a
considered non-threshold. For more comprehensive dietary exposure
A. Toxicological Profile information on the general principles analysis and risk assessment for
EPA has evaluated the available EPA uses in risk characterization and a Trifloxystrobin in drinking water.
toxicity data and considered its validity, complete description of the risk Because the Agency does not have
completeness, and reliability as well as assessment process, see http:// comprehensive monitoring data,
the relationship of the results of the www.epa.gov/oppfead1/trac/science; drinking water concentration estimates
studies to human risk. EPA has also http://www.epa.gov/pesticides/ are made by reliance on simulation or
considered available information factsheets/riskassess.htm; http:// modeling taking into account data on
concerning the variability of the www.epa.gov/pesticides/trac/science/ the environmental fate characteristics of
sensitivities of major identifiable aggregate.pdf Trifloxystrobin. Further information
subgroups of consumers, including A summary of the toxicological regarding EPA drinking water models
infants and children. Specific endpoints for Trifloxystrobin used for used in pesticide exposure assessment
information on the studies received and human risk assessment can be found at can be found at http://www.epa.gov/
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the nature of the adverse effects caused http://www.regulations.gov in document oppefed1/models/water/index.htm.


by Trifloxystrobin as well as the no- Trifloxystrobin: Human Health Risk Based on the First Index Reservoir
observed-adverse-effect-level (NOAEL) Assessment for Section 3 Registration Screening Tool (FIRST), Screening
and the lowest-observed-adverse-effect- for the Proposed Uses on Grasses Grown Concentration in Ground Water (SCI-
level (LOAEL) from the toxicity studies for Seed. Petition No: 6F7024 at page 16 GROW) models, and rice paddies

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method the estimated environmental D. Safety Factor for Infants and ii. There is no residual concern for
concentrations (EECs) of Trifloxystrobin Children pre- or post-natal toxicity or increased
and the metabolite CGA–321113 for 1. In general. Section 408 of the sensitivity in infants and children. In
acute exposures are estimated to be 92 FFDCA provides that EPA shall apply both the rat developmental study and
parts per billion (ppb) for surface water an additional (‘‘10X’’) tenfold margin of the 2–generation reproduction study
and 3.4 ppb for ground water. The EECs safety for infants and children in the there were no effects in fetal animals or
for chronic exposures are estimated to case of threshold effects to account for offspring at the highest dose tested.
be 140 ppb for surface water and 3.4 prenatal and postnatal toxicity and the Although developmental effects were
ppb for ground water. completeness of the database on toxicity seen in the rabbit developmental study,
Modeled estimates of drinking water and exposure unless EPA determines there was a clear NOAEL identified for
concentrations were directly entered these effects and that NOAEL was used
based on reliable data that a different
into the dietary exposure model. For in setting the aPAD. Moreover, adverse
margin of safety will be safe for infants
acute dietary risk assessment, the water effects were seen in the adult animals in
and children. This additional margin of
concentration value of 92 ppb was used this study at a lower level.
safety is commonly referred to as the iii. There are no residual uncertainties
to access the contribution to drinking FQPA safety factor. In applying this identified in the exposure databases.
water. For chronic dietary risk provision, EPA either retains the default The dietary food exposure assessments
assessment, the water concentration of value of 10X when reliable data do not were performed based on 100% CT and
value 140 ppb was used to access the support the choice of a different factor, tolerance-level residues Conservative
contribution to drinking water. or, if reliable data are available, EPA ground water and surface water
3. From non-dietary exposure. The uses a different additional FQPA safety modeling estimates were used. Similarly
term ‘‘residential exposure’’ is used in factor value based on the use of conservative Residential SOPs were
this document to refer to non- traditional UFs and/or special FQPA used to assess post-application exposure
occupational, non-dietary exposure safety factors, as appropriate. to children as well as incidental oral
(e.g., for lawn and garden pest control, 2. Prenatal and postnatal sensitivity. exposure of toddlers. These assessments
indoor pest control, termiticides, and In the prenatal developmental study in will not underestimate the exposure and
flea and tick control on pets). rats there was no developmental toxicity risks posed by Trifloxystrobin].
Trifloxystrobin is currently registered at the Limit Dose. In the prenatal
developmental study in rabbits, E. Aggregate Risks and Determination of
for the following residential non-dietary
developmental toxicity was seen at a Safety
sites: Turfgrass and ornamentals. EPA
assessed residential exposure using the dose that was higher than the dose that Safety is assessed for acute and
following assumption: Non- caused maternal toxicity. In the 2– chronic risks by comparing aggregate
occupational postapplication contact generation reproduction study, there exposure to the pesticide to the aPAD
with trifloxystrobin following was no offspring toxicity at the highest and cPAD. The aPAD and cPAD are
Compass use on turfgrass is the most dose tested. calculated by dividing the LOC by all
3. Conclusion. EPA has determined applicable UFs. For linear cancer risks,
common and worst case contributor to
that reliable data show that it would be EPA calculates the probability of
such exposures.
safe for infants and children to reduce additional cancer cases given aggregate
4. Cumulative effects from substances the FQPA safety factor to 1X. That
with a common mechanism of toxicity. exposure. Short-term, intermediate-
decision is based on the following term, and long-term risks are evaluated
Section 408(b)(2)(D)(v) of the FFDCA findings:
requires that, when considering whether by comparing aggregate exposure to the
i. The toxicity database for LOC to ensure that the MOE called for
to establish, modify, or revoke a Trifloxystrobin is complete except for
tolerance, the Agency consider by the product of all applicable UFs is
an acute neurotoxicity study which is not exceeded.
‘‘available information’’ concerning the classified as unacceptable. The toxicity 1. Acute risk. Using the exposure
cumulative effects of a particular database contains developmental assumptions discussed in this unit for
pesticide’s residues and ‘‘other toxicity studies in two species (rats and acute exposure, the acute dietary
substances that have a common rabbits) and a 2–generation exposure from food and water to
mechanism of toxicity.’’ reproduction study in rats which are Trifloxystrobin will occupy <1% of the
Unlike other pesticides for which EPA adequate to assess pre and/or post natal aPAD for the population group (females
has followed a cumulative risk approach susceptibility to infants and children. 13–49 years old) receiving the greatest
based on a common mechanism of Although the available, submitted acute exposure.
toxicity, EPA has not made a common neurotoxicity study was found to be 2. Chronic risk. Using the exposure
mechanism of toxicity finding as to unacceptable, based on a weight-of-the assumptions described in this unit for
Trifloxystrobin and any other evidence review of the available data, chronic exposure, EPA has concluded
substances and Trifloxystrobin does not the lack of this study does not impact that exposure to Trifloxystrobin from
appear to produce a toxic metabolite the Agency’s ability to make an FQPA food and water will utilize 81% of the
produced by other substances. For the safety factor decision. Given that there cPAD for the population group (children
purposes of this tolerance action, was no evidence of neurotoxicity in this 1–2 years old, the most highly exposed
therefore, EPA has not assumed that study at the Limit Dose nor in the other subgroup). Based on the use pattern,
Trifloxystrobin has a common subchronic and chronic studies in the chronic residential exposure to residues
mechanism of toxicity with other database there is not an uncertainty of Trifloxystrobin is not expected.
substances. For information regarding concerning neurotoxic effects and EPA 3. Short-term risk. Short-term
EPA’s efforts to determine which has reliable data to show that removal aggregate exposure takes into account
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chemicals have a common mechanism of the FQPA safety factor is safe for residential exposure plus chronic
of toxicity and to evaluate the children. Additionally, these data exposure to food and water (considered
cumulative effects of such chemicals, demonstrate that a developmental to be a background exposure level).
see EPA’s website at http:// neurotoxicity study is not required for Trifloxystrobin is currently registered
www.epa.gov/pesticides/cumulative. this pesticide. for uses that could result in short-term

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53444 Federal Register / Vol. 72, No. 181 / Wednesday, September 19, 2007 / Rules and Regulations

residential exposure and the Agency has and the acid metabolite, CGA321113. Risks (62 FR 19885, April 23, 1997).
determined that it is appropriate to Therefore, harmonization in plant This final rule does not contain any
aggregate chronic food and water and commodities is not possible at this time information collections subject to OMB
short-term exposures for as the current U.S. tolerance definition approval under the Paperwork
Trifloxystrobin. includes the combined residues of Reduction Act (PRA), 44 U.S.C. 3501 et
Using the exposure assumptions trifloxystrobin and its free acid seq., nor does it require any special
described in this unit for short-term metabolite. Harmonization of the considerations under Executive Order
exposures, EPA has concluded that tolerance level in meat by-products of 12898, entitled Federal Actions to
food, water, and residential exposures cattle, goats, and sheep is not possible Address Environmental Justice in
aggregated result in aggregate MOEs at this time as the U.S. tolerance in meat Minority Populations and Low-Income
greater than 100 for adults and children by-products reflects higher potential Populations (59 FR 7629, February 16,
1–2 years. Therefore, the Agency does exposures to various feedstuffs. 1994).
not consider short term aggregate risk to Since tolerances and exemptions that
C. Response to Comments are established on the basis of a petition
be of concern.
4. Intermediate-term risk. One comment was received from B. under section 408(d) of the FFDCA,
Intermediate-term aggregate exposure Sachau. Ms. Sachau’s comments such as the tolerance in this final rule,
takes into account residential exposure regarding general exposure to pesticides do not require the issuance of a
plus chronic exposure to food and water contained no scientific data or evidence proposed rule, the requirements of the
(considered to be a background to rebut the Agency’s conclusion that Regulatory Flexibility Act (RFA) (5
exposure level). there is a reasonable certainty that no U.S.C. 601 et seq.) do not apply.
Though residential exposure could harm will result from aggregate This final rule directly regulates
occur intermediate-term aggregate risk is exposure to trilfoxystrobin, including all growers, food processors, food handlers,
not expected based on the short soil anticipated dietary exposures and other and food retailers, not States or tribes,
half-life (about 2 days). Therefore, an exposures for which there is reliable nor does this action alter the
intermediate-term aggregate risk information. This comment as well as relationships or distribution of power
assessment was not performed. her comments regarding animal testing and responsibilities established by
5. Aggregate cancer risk for U.S. have been responded to by the Agency Congress in the preemption provisions
population. The Agency classified on several occasions. For examples, see of section 408(n)(4) of the FFDCA. As
trifloxystrobin as a ‘‘not likely’’ human the Federal Register issues of January 7, such, the Agency has determined that
carcinogen. Therefore, trifloxystrobin is 2005 (70 FR 1349) (FRL–7691–4) and this action will not have a substantial
not expected to pose a cancer risk. October 29, 2004 (69 FR 63083) (FRL– direct effect on States or tribal
6. Determination of safety. Based on 7681–9). governments, on the relationship
these risk assessments, EPA concludes between the national government and
V. Conclusion the States or tribal governments, or on
that there is a reasonable certainty that
Therefore, the tolerance is established the distribution of power and
no harm will result to the general
for combined residues of responsibilities among the various
population or to infants and children
Trifloxystrobin, (benzeneacetic acid, levels of government or between the
from aggregate exposure to
(E,E)-a-(methoxyimino)-2-[[[[1-[3- Federal Government and Indian tribes.
trifloxystrobin residues.
(trifluoromethyl) Thus, the Agency has determined that
IV. Other Considerations phenyl]ethylidene]amino]oxy] methyl]- Executive Order 13132, entitled
methyl ester) and the free form of its Federalism (64 FR 43255, August 10,
A. Analytical Enforcement Methodology
acid metabolite CGA–321113 (E,E)- 1999) and Executive Order 13175,
Adequate enforcement methodology methoxyimino-[2-[1-(3- entitled Consultation and Coordination
(Gas Chromatography with a nitrogen trifluoromethylphenyl)- with Indian Tribal Governments (65 FR
phosphorus detector (GC/NPD method ethylideneaminooxymethyl]-phenyl] 67249, November 6, 2000) do not apply
(Method AG–659A)) is available to acetic acid in or on grass, forage at to this rule. In addition, This rule does
enforce the tolerance expression. The tolerance level 12 ppm and grass, hay at not impose any enforceable duty or
method may be requested from: Chief, tolerance level 17 ppm. contain any unfunded mandate as
Analytical Chemistry Branch, described under Title II of the Unfunded
Environmental Science Center, 701 VI. Statutory and Executive Order
Reviews Mandates Reform Act of 1995 (UMRA)
Mapes Rd., Ft. Meade, MD 20755–5350; (Public Law 104–4).
telephone number: (410) 305–2905; e- This final rule establishes a tolerance This action does not involve any
mail address: residuemethods@epa.gov. under section 408(d) of the FFDCA in technical standards that would require
response to a petition submitted to the Agency consideration of voluntary
B. International Residue Limits Agency. The Office of Management and consensus standards pursuant to section
There are currently no Canadian Budget (OMB) has exempted these types 12(d) of the National Technology
Maximum Residue Levels (MRLs) for of actions from review under Executive Transfer and Advancement Act of 1995
trifloxystrobin. Codex and Mexican Order 12866, entitled Regulatory (NTTAA), Public Law 104–113, section
MRLs have been established for Planning and Review (58 FR 51735, 12(d) (15 U.S.C. 272 note).
trifloxystrobin in/on various October 4, 1993). Because this rule has
commodities; however, there are no been exempted from review under VII. Congressional Review Act
MRLs for the commodities associated Executive Order 12866, this rule is not The Congressional Review Act, 5
with the proposed use of trifloxystrobin subject to Executive Order 13211, U.S.C. 801 et seq., generally provides
in/on grasses grown for seed. Also, the Actions Concerning Regulations That that before a rule may take effect, the
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residue definition for both Codex and Significantly Affect Energy Supply, agency promulgating the rule must
Mexican MRLs includes only parent Distribution, or Use (66 FR 28355, May submit a rule report to each House of
compound in plant commodities, but 22, 2001) or Executive Order 13045, the Congress and to the Comptroller
the definition for Codex MRLs in entitled Protection of Children from General of the United States. EPA will
livestock commodities includes parent Environmental Health Risks and Safety submit a report containing this rule and

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Federal Register / Vol. 72, No. 181 / Wednesday, September 19, 2007 / Rules and Regulations 53445

other required information to the U.S. requests for hearings must be received • Food manufacturing (NAICS code
Senate, the U.S. House of on or before November 19, 2007, and 311), e.g., agricultural workers; farmers;
Representatives, and the Comptroller must be filed in accordance with the greenhouse, nursery, and floriculture
General of the United States prior to instructions provided in 40 CFR part workers; ranchers; pesticide applicators.
publication of this final rule in the 178 (see also Unit I.C. of the • Pesticide manufacturing (NAICS
Federal Register. This final rule is not SUPPLEMENTARY INFORMATION). code 32532), e.g., agricultural workers;
a ‘‘major rule’’ as defined by 5 U.S.C. ADDRESSES: EPA has established a commercial applicators; farmers;
804(2). docket for this action under docket greenhouse, nursery, and floriculture
identification (ID) number EPA–HQ– workers; residential users.
List of Subjects in 40 CFR Part 180 This listing is not intended to be
OPP–2006–0297. To access the
Environmental protection, electronic docket, go to http:// exhaustive, but rather to provide a guide
Administrative practice and procedure, www.regulations.gov, select ‘‘Advanced for readers regarding entities likely to be
Agricultural commodities, Pesticides affected by this action. Other types of
Search,’’ then ‘‘Docket Search.’’ Insert
and pests, Reporting and recordkeeping the docket ID number where indicated entities not listed in this unit could also
requirements. be affected. The North American
and select the ‘‘Submit’’ button. Follow
Industrial Classification System
Dated: September 10, 2007. the instructions on the regulations.gov
(NAICS) codes have been provided to
Daniel J. Rosenblatt, website to view the docket index or
assist you and others in determining
Acting Director, Registration Division, Office access available documents. All
whether this action might apply to
of Pesticide Programs. documents in the docket are listed in
certain entities. If you have any
■ Therefore, 40 CFR chapter I is
the docket index available in
questions regarding the applicability of
amended as follows: regulations.gov. Although listed in the
this action to a particular entity, consult
index, some information is not publicly
the person listed under FOR FURTHER
PART 180—[AMENDED] available, e.g., Confidential Business
INFORMATION CONTACT.
Information (CBI) or other information
■ 1. The authority citation for part 180 whose disclosure is restricted by statute. B. How Can I Access Electronic Copies
continues to read as follows: Certain other material, such as of this Document?
Authority: 21 U.S.C. 321(q), 346a and 371. copyrighted material, is not placed on In addition to accessing an electronic
■ 2. Section 180.555 is amended by the Internet and will be publicly copy of this Federal Register document
alphabetically adding the following available only in hard copy form. through the electronic docket at http://
commodities in the table in paragraph Publicly available docket materials are www.regulations.gov, you may access
(a): available in the electronic docket at this Federal Register document
http://www.regulations.gov, or, if only electronically through the EPA Internet
§ 180.555 Trifloxystrobin; tolerances for available in hard copy, at the OPP under the ‘‘Federal Register’’ listings at
residues. Regulatory Public Docket in Rm. S– http://www.epa.gov/fedrgstr. You may
(a) * * * 4400, One Potomac Yard (South Bldg.), also access a frequently updated
2777 S. Crystal Dr., Arlington, VA. The electronic version of EPA’s tolerance
Commodity Parts per million Docket Facility is open from 8:30 a.m. regulations at 40 CFR part 180 through
to 4 p.m., Monday through Friday, the Government Printing Office’s pilot
* * * * *
Grass, forage .................. 12
excluding legal holidays. The Docket e-CFR site at http://www.gpoaccess.gov/
Grass, hay ...................... 17 Facility telephone number is (703) 305– ecfr.
* * * * * 5805.
FOR FURTHER INFORMATION CONTACT:
C. Can I File an Objection or Hearing
* * * * * Sidney Jackson, Registration Division Request?
[FR Doc. E7–18371 Filed 9–18–07; 8:45 am] (7505P), Office of Pesticide Programs, Under section 408(g) of the FFDCA,
BILLING CODE 6560–50–S Environmental Protection Agency, 1200 any person may file an objection to any
Pennsylvania Ave., NW., Washington, aspect of this regulation and may also
DC 20460–0001; telephone number: request a hearing on those objections.
ENVIRONMENTAL PROTECTION (703) 305–7610; e-mail address: You must file your objection or request
AGENCY jackson.sidney@epa.gov. a hearing on this regulation in
accordance with the instructions
SUPPLEMENTARY INFORMATION:
40 CFR Part 180 provided in 40 CFR part 178. To ensure
EPA–HQ–OPP–2006–0297; FRL–8146–8] I. General Information proper receipt by EPA, you must
identify docket ID number EPA–HQ–
A. Does this Action Apply to Me?
Desmedipham; Pesticide Tolerance OPP–2006–0297 in the subject line on
You may be potentially affected by the first page of your submission. All
AGENCY: Environmental Protection this action if you are an agricultural requests must be in writing, and must be
Agency (EPA). producer, food manufacturer, or mailed or delivered to the Hearing Clerk
ACTION: Final rule. pesticide manufacturer. Potentially as required by 40 CFR part 178 on or
affected entities may include, but are before November 19, 2007.
SUMMARY: This regulation establishes a not limited to those engaged in the In addition to filing an objection or
tolerance for residues of desmedipham following activities: hearing request with the Hearing Clerk
in or on beet, garden, roots; beet, garden, • Crop production (NAICS code 111), as described in 40 CFR part 178, please
tops and spinach. The Interregional e.g., agricultural workers; greenhouse, submit a copy of the filing that does not
yshivers on PROD1PC66 with RULES

Research Project No. 4 (IR-4) requested nursery, and floriculture workers; contain any CBI for inclusion in the
this tolerance under the Federal Food, farmers. public docket that is described in
Drug, and Cosmetic Act (FFDCA). • Animal production (NAICS code ADDRESSES. Information not marked
DATES: This regulation is effective 112), e.g., cattle ranchers and farmers, confidential pursuant to 40 CFR part 2
September 19, 2007. Objections and dairy cattle farmers, livestock farmers. may be disclosed publicly by EPA

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