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Federal Register
/ Vol. 72, No. 4 / Monday, January 8, 2007 / Rules and Regulations
Issued in College Park, Georgia, onDecember 14, 2006.
Kathy Kutch,
Manager, System Support Group, EasternService Center.
[FR Doc. 06
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DEPARTMENT OF HEALTH ANDHUMAN SERVICESFood and Drug Administration21 CFR Part 558New Animal Drugs For Use in AnimalFeeds; Monensin
AGENCY
:
Food and Drug Administration, HHS.
ACTION
:
Final rule.
SUMMARY
:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the concentration of monensin in Type C medicated feeds used for improved feed efficiency, and for the prevention and control of coccidiosis in cattle fed in confinement for slaughter.
DATES
:
This rule is effective January 8, 2007.
FOR FURTHER INFORMATION CONTACT
:
Eric S. Dubbin, Center for VeterinaryMedicine (HFV
–
126), Food and DrugAdministration, 7500 Standish Pl.,Rockville, MD 20855, 301
–
827
–
SUPPLEMENTARY INFORMATION
:
ElancoAnimal Health, A Division of Eli Lilly& Co., Lilly Corporate Center,Indianapolis, IN 46285, filed asupplement to NADA 95
–
735 thatprovides for use of RUMENSIN 80(monensin) Type A medicated articles.The supplement revises theconcentration of monensin in Type Cmedicated feeds used for improved feedefficiency, and for the prevention andcontrol of coccidiosis in cattle fed inconfinement for slaughter. Thesupplemental NADA is approved as of December 1, 2006, and the regulationsin 21 CFR 558.355 are amended toreflect the approval. The basis of approval is discussed in the freedom of information summary.In accordance with the freedom of information provisions of 21 CFR part20 and 21 CFR 514.11(e)(2)(ii), asummary of safety and effectivenessdata and information submitted tosupport approval of this applicationmay be seen in the Division of DocketsManagement (HFA
–
305), Food and DrugAdministration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852, between 9a.m. and 4 p.m., Monday throughFriday.FDA has carefully considered thepotential environmental impact of thisaction and has concluded that the actionwill not have a significant impact on thehuman environment and that anenvironmental impact statement is notrequired. FDA
’
s finding of no significantimpact and the evidence supporting thatfinding, contained in an environmentalassessment, may be seen in the Divisionof Dockets Management (address above) between 9 a.m. and 4 p.m., Mondaythrough Friday.This rule does not meet the definitionof
‘‘
rule
’’
in 5 U.S.C. 804(3)(A) becauseit is a rule of
‘‘
particular applicability.
’’
Therefore, it is not subject to thecongressional review requirements in 5U.S.C. 801
–
808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
■
Therefore, under the Federal Food,Drug, and Cosmetic Act and underauthority delegated to the Commissionerof Food and Drugs and redelegated tothe Center for Veterinary Medicine, 21CFR part 558 is amended as follows:
PART 558
—
NEW ANIMAL DRUGS FORUSE IN ANIMAL FEEDS
■
1. The authority citation for 21 CFRpart 558 continues to read as follows:
Authority:
21 U.S.C. 360b, 371.
■
2. Section 558.355 is amended asfollows:a. Revise paragraph (d)(2); b. Revise the introductory text of paragraphs (f)(3)(i) and (f)(3)(vii);c. Revise paragraph (f)(3)(vii)(
b
);d. Amend paragraph (f)(3)(i)(
b
)(
1
) byrevising the second sentence and addinga new third sentence.The revisions read as follows:
§
558.355 Monensin.
* * * * *(d) * * *(2) Type C cattle feeds containing 40grams or less monensin per ton shall bear an expiration date of 30 days afterits date of manufacture.(f) * **(3) * * *(i) [
Amount per ton
]. Monensin, 5 to40 grams.(
b
) ***(
1
)
Limitations
. * * * Feedcontinuously in complete feed at a rateof 50 to 480 milligrams of monensin perhead per day. No additionalimprovement in feed efficiency has beenshown from feeding monensin at levelsgreater than 30 grams per ton (360milligrams per head per day). * * ** * * * *(vii)
Amount per ton
. Monensin, 10 to40 grams.* * * * *(
b
)
Limitations
. For cattle fed inconfinement for slaughter, feed at a rateof 0.14 to 0.42 milligram per pound of body weight per day, depending uponthe severity of challenge, up tomaximum of 480 milligrams per headper day.* * * * *
Dated: December 19, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E7
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ENVIRONMENTAL PROTECTIONAGENCY40 CFR Part 52
[EPA
–
R03
–
OAR
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2006
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0648; FRL
–
8266
–
1]
Approval and Promulgation of AirQuality Implementation Plans; Virginia;Identification of the Northern VirginiaPM2.5 Nonattainment Area
AGENCY
:
Environmental Protection Agency (EPA).
ACTION
:
Direct final rule.
SUMMARY
:
EPA is taking direct finalaction to approve revisions to theVirginia State Implementation Plan(SIP). The revision consists of theaddition of counties in NorthernVirginia which were designated asnonattainment for the fine particulate(PM2.5) national ambient air qualitystandard (NAAQS). EPA is approvingthis revision in accordance with therequirements of the Clean Air Act.
DATES
:
This rule is effective on March 9,2007 without further notice, unless EPAreceives adverse written comment byFebruary 7, 2007. If EPA receives suchcomments, it will publish a timelywithdrawal of the direct final rule in the
Federal Register
and inform the publicthat the rule will not take effect.
ADDRESSES
:
Submit your comments,identified by Docket ID Number EPA-R03-OAR
–
2006
–
0648 by one of thefollowing methods:A.
C. Mail: EPA
–
R03
–
OAR
–
2006
–
0648,Linda Miller, Acting Chief, Air QualityPlanning and Analysis Branch,
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/ Vol. 72, No. 4 / Monday, January 8, 2007 / Rules and Regulations
Mailcode 3AP21, U.S. EnvironmentalProtection Agency, Region III, 1650Arch Street, Philadelphia, Pennsylvania19103.D. Hand Delivery: At the previously-listed EPA Region III address. Suchdeliveries are only accepted during theDocket
’
s normal hours of operation, andspecial arrangements should be madefor deliveries of boxed information.
Instructions:
Direct your comments toDocket ID No EPA
–
R03
–
OAR
–
2006
–
0648. EPA
’
s policy is that all commentsreceived will be included in the publicdocket without change, and may bemade available online at
including anypersonal information provided, unlessthe comment includes informationclaimed to be Confidential BusinessInformation (CBI) or other informationwhose disclosure is restricted by statute.Do not submit information that youconsider to be CBI or otherwiseprotected through
or e-mail. The
‘‘
anonymous access
’’
system,which means EPA will not know youridentity or contact information unlessyou provide it in the body of yourcomment. If you send an e-mailcomment directly to EPA without goingthrough
your e-mail address will be automaticallycaptured and included as part of thecomment that is placed in the publicdocket and made available on theInternet. If you submit an electroniccomment, EPA recommends that youinclude your name and other contactinformation in the body of yourcomment and with any disk or CD
–
ROMyou submit. If EPA cannot read yourcomment due to technical difficultiesand cannot contact you for clarification,EPA may not be able to consider yourcomment. Electronic files should avoidthe use of special characters, any formof encryption, and be free of any defectsor viruses.
Docket:
All documents in theelectronic docket are listed in the
i.e.
, CBI or otherinformation whose disclosure isrestricted by statute. Certain othermaterial, such as copyrighted material,is not placed on the Internet and will bepublicly available only in hard copyform. Publicly available docketmaterials are available eitherelectronically in
or in hard copy during normal businesshours at the Air Protection Division,U.S. Environmental Protection Agency,Region III, 1650 Arch Street,Philadelphia, Pennsylvania 19103.Copies of the State submittal areavailable at the Virginia Department of Environmental Quality, 629 East MainStreet, Richmond, Virginia, 23219.
FOR FURTHER INFORMATION CONTACT
:
Linda Miller, (215) 814
–
SUPPLEMENTARY INFORMATION
:
I. Background
On May 8, 2006, the Commonwealthof Virginia submitted a formal revisionto its State Implementation Plan (SIP).The SIP revision consists of the additionof counties in the Northern VirginiaPM2.5 nonattainment area to the airquality regulations in the Virginia Code(9 VAC 5
–
20
–
204). This section of theVirginia regulations identifies areasincluded in nonattainment areas for theNational Ambient Air Quality Standards(NAAQS).On July 18, 1997, EPA revised theNAAQS for particulate matter to add anew standard for fine particulates(PM
2.5
), airborne particles with anominal aerodynamic diameter of 2.5micrometers or less. The health-basedstandards for air quality are the PM
2.5
annual NAAQS, 15 micrograms percubic meter, based on a 3-year averageof annual mean PM
2.5
concentrations;and the 24-hour NAAQS. 65 microgramsper cubic meter based on a 3-yearaverage of the 98th percentile of 24-hourconcentrations. Nonattainment areas forthe fine particle standard (PM
2.5
) werepromulgated by EPA on January 5, 2005as required by section 197(d) of theClean Air Act (CAA). Additionalinformation on the designation processand requirements for nonattainmentareas is found in the
Federal Register
document for the designations (70 FR944 and 71 FR 19844). The designationof these counties and local jurisdictionsin a PM
2.5
nonattainment area is not thesubject of this rulemaking.
II. Summary of SIP Revision
The Commonwealth of Virginia isamending 9 VAC 5
–
20
–
204.A.3 toinclude the previously designatedcounties and local jurisdictions into theNorthern Virginia portion of theWashington, DC PM
2.5
nonattainmentarea. The counties and local areasincluded in the nonattainment area areArlington County, Fairfax County,Loudon County, Prince William,Alexandria City, Fairfax City, FallsChurch City, Manassas City, andManassas Park City. This SIP revisionapproves the addition of these countiesand local jurisdictions to the planningareas listed in the Virginia Code (9 VAC5
–
20
–
204.A.3).
III. General Information Pertaining toSIP Submittals From theCommonwealth of Virginia
In 1995, Virginia adopted legislationthat provides, subject to certainconditions, for an environmentalassessment (audit)
‘‘
privilege
’’
forvoluntary compliance evaluationsperformed by a regulated entity. Thelegislation further addresses the relative burden of proof for parties eitherasserting the privilege or seekingdisclosure of documents for which theprivilege is claimed. Virginia
’
slegislation also provides, subject tocertain conditions, for a penalty waiverfor violations of environmental lawswhen a regulated entity discovers suchviolations pursuant to a voluntarycompliance evaluation and voluntarilydiscloses such violations to theCommonwealth and takes prompt andappropriate measures to remedy theviolations. Virginia
’
s VoluntaryEnvironmental Assessment PrivilegeLaw, Va. Code Sec. 10.1
–
1198, providesa privilege that protects from disclosuredocuments and information about thecontent of those documents that are theproduct of a voluntary environmentalassessment. The Privilege Law does notextend to documents or information (1)That are generated or developed beforethe commencement of a voluntaryenvironmental assessment; (2) that areprepared independently of theassessment process; (3) that demonstratea clear, imminent and substantialdanger to the public health orenvironment; or (4) that are required bylaw.On January 12, 1998, theCommonwealth of Virginia Office of theAttorney General provided a legalopinion that states that the Privilegelaw, Va. Code Sec. 10.1
–
1198, precludesgranting a privilege to documents andinformation
‘‘
required by law,
’’
including documents and information
‘‘
required by Federal law to maintainprogram delegation, authorization orapproval,
’’
since Virginia must
‘‘
enforceFederally authorized environmentalprograms in a manner that is no lessstringent than their Federal counterparts***.
’’
The opinion concludes that
‘‘
[r]egarding
§
10.1
–
1198, therefore,documents or other information neededfor civil or criminal enforcement underone of these programs could not beprivileged because such documents andinformation are essential to pursuingenforcement in a manner required byFederal law to maintain programdelegation, authorization or approval.
’’
Virginia
’
s Immunity law, Va. CodeSec. 10.1
–
1199, provides that
‘‘
[t]o theextent consistent with requirements
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imposed by Federal law,
’’
any personmaking a voluntary disclosure of information to a state agency regardinga violation of an environmental statute,regulation, permit, or administrativeorder is granted immunity fromadministrative or civil penalty. TheAttorney General
’
s January 12, 1998opinion states that the quoted languagerenders this statute inapplicable toenforcement of any Federally authorizedprograms, since
‘‘
no immunity could beafforded from administrative, civil, orcriminal penalties because grantingsuch immunity would not be consistentwith Federal law, which is one of thecriteria for immunity.
’’
Therefore, EPA has determined thatVirginia
’
s Privilege and Immunitystatutes will not preclude theCommonwealth from enforcing itsprogram consistent with the Federalrequirements. In any event, becauseEPA has also determined that a stateaudit privilege and immunity law canaffect only state enforcement and cannothave any impact on Federalenforcement authorities, EPA may atany time invoke its authority under theClean Air Act, including, for example,sections 113, 167, 205, 211 or 213, toenforce the requirements or prohibitionsof the state plan, independently of anystate enforcement effort. In addition,citizen enforcement under section 304of the Clean Air Act is likewiseunaffected by this, or any, state auditprivilege or immunity law.
IV. Final Action
EPA is approving the revision (VAD05) which identifies areas designatedas part of the Northern Virginia portionof the Washington, DC PM
2.5
nonattainment area. EPA is publishingthis rule without prior proposal becausethe Agency views this as anoncontroversial amendment andanticipates no adverse comment. Thedesignation process includedopportunity for public comment. Inaddition, there were no publiccomments in the State publicparticipation process. However, in the
‘‘
Proposed Rules
’’
section of today
’
s
Federal Register
, EPA is publishing aseparate document that will serve as theproposal to approve the SIP revision if adverse comments are filed. This rulewill be effective on March 9, 2007without further notice unless EPAreceives adverse comment by February7, 2007. If EPA receives adversecomment, EPA will publish a timelywithdrawal in the
Federal Register
informing the public that the rule willnot take effect. EPA will address allpublic comments in a subsequent finalrule based on the proposed rule. EPAwill not institute a second commentperiod on this action. Any partiesinterested in commenting must do so atthis time.
V. Statutory and Executive OrderReviews
A. General Requirements
Under Executive Order 12866 (58 FR51735, October 4, 1993), this action isnot a
‘‘
significant regulatory action
’’
andtherefore is not subject to review by theOffice of Management and Budget. Forthis reason, this action is also notsubject to Executive Order 13211,
‘‘
Actions Concerning Regulations ThatSignificantly Affect Energy Supply,Distribution, or Use
’’
(66 FR 28355, May22, 2001). This action merely approvesstate law as meeting Federalrequirements and imposes no additionalrequirements beyond those imposed bystate law. Accordingly, theAdministrator certifies that this rulewill not have a significant economicimpact on a substantial number of smallentities under the Regulatory FlexibilityAct (5 U.S.C. 601
et seq.
). Because thisrule approves pre-existing requirementsunder state law and does not imposeany additional enforceable duty beyondthat required by State law, it does notcontain any unfunded mandate orsignificantly or uniquely affect smallgovernments, as described in theUnfunded Mandates Reform Act of 1995(Pub. L. 104
–
4). This rule also does nothave tribal implications because it willnot have a substantial direct effect onone or more Indian tribes, on therelationship between the FederalGovernment and Indian tribes, or on thedistribution of power andresponsibilities between the FederalGovernment and Indian tribes, asspecified by Executive Order 13175 (65FR 67249, November 9, 2000). Thisaction also does not have Federalismimplications because it does not havesubstantial direct effects on the States,on the relationship between the nationalgovernment and the States, or on thedistribution of power andresponsibilities among the variouslevels of government, as specified inExecutive Order 13132 (64 FR 43255,August 10, 1999). This action merelyapproves a state rule implementing aFederal requirement, and does not alterthe relationship or the distribution of power and responsibilities establishedin the Clean Air Act. This rule also isnot subject to Executive Order 13045
‘‘
Protection of Children fromEnvironmental Health Risks and SafetyRisks
’’
(62 FR 19885, April 23, 1997), because it is not economicallysignificant.In reviewing SIP submissions, EPA
’
srole is to approve state choices,provided that they meet the criteria of the Clean Air Act. In this context, in theabsence of a prior existing requirementfor the State to use voluntary consensusstandards (VCS), EPA has no authorityto disapprove a SIP submission forfailure to use VCS. It would thus beinconsistent with applicable law forEPA, when it reviews a SIP submission,to use VCS in place of a SIP submissionthat otherwise satisfies the provisions of the Clean Air Act. Thus, therequirements of section 12(d) of theNational Technology Transfer andAdvancement Act of 1995 (15 U.S.C.272 note) do not apply. This rule doesnot impose an information collection burden under the provisions of thePaperwork Reduction Act of 1995 (44U.S.C. 3501
et seq.
).
B. Submission to Congress and theComptroller General
The Congressional Review Act, 5U.S.C. 801
et seq.
, as added by the SmallBusiness Regulatory EnforcementFairness Act of 1996, generally providesthat before a rule may take effect, theagency promulgating the rule mustsubmit a rule report, which includes acopy of the rule, to each House of theCongress and to the Comptroller Generalof the United States. EPA will submit areport containing this rule and otherrequired information to the U.S. Senate,the U.S. House of Representatives, andthe Comptroller General of the UnitedStates prior to publication of the rule inthe
Federal Register
. This rule is not a
‘‘
major rule
’’
as defined by 5 U.S.C.804(2).
C. Petitions for Judicial Review
Under section 307(b)(1) of the CleanAir Act, petitions for judicial review of this action must be filed in the UnitedStates Court of Appeals for theappropriate circuit by March 9, 2007.Filing a petition for reconsideration by the Administrator of this final rule toupdate the Virginia regulations toinclude counties and local jurisdictionsin the Northern Virginia PM2.5nonattainment area does not affect thefinality of this rule for the purposes of judicial review nor does it extend thetime within which a petition for judicialreview may be filed, and shall notpostpone the effectiveness of such ruleor action. This action may not bechallenged later in proceedings toenforce its requirements. (See section307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Airpollution control, Particulate matter,
of 00
Environmental Protection Agency: a22552
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