Pyraflufen-Ethyl; Extension of Time-Limited Pesticide Tolerances, 75859-75862 [2012-31067]

Download as PDF tkelley on DSK3SPTVN1PROD with Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it 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). Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in this final rule, do 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. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). 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 of 1995 (NTTAA) (15 U.S.C. 272 note). VerDate Mar<15>2010 04:58 Dec 22, 2012 Jkt 229001 VIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 12, 2012. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.641, add alphabetically the following new entry to the table in paragraph (b). ■ § 180.641 Spirotetramat; tolerances for residues. * * * (b) * * * * Commodity Parts per million * * Watercress .... * 1.5 * * * * * Expiration date * * 12/31/15 * [FR Doc. 2012–30854 Filed 12–21–12; 4:15 pm] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2012–0750; FRL–9373–5] Pyraflufen-Ethyl; Extension of TimeLimited Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation extends already established time-limited tolerances for residues of pyraflufenethyl in or on cattle, meat byproducts; goat, meat byproducts; horse, meat SUMMARY: PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 75859 byproducts; sheep, meat byproducts; and milk. Nichino America, Inc. requested the tolerance extensions under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 26, 2012. Objections and requests for hearings must be received on or before February 25, 2013, 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: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2012–0750, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. 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) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Kathryn Montague, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–1243; email address: montague.kathryn@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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 E:\FR\FM\26DER1.SGM 26DER1 75860 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations through the Government Printing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/ textidx?&c=ecfr&tpl=/ecfrbrowse/ Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https://www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ tkelley on DSK3SPTVN1PROD with C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2012–0750 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 25, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2012–0750, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets. VerDate Mar<15>2010 04:58 Dec 22, 2012 Jkt 229001 II. Summary of Petitioned-For Tolerance Extension In the Federal Register of September 28, 2012 (77 FR 59576) (FRL–9363–8), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8075 by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be amended by extending the expiration date for temporary tolerances for residues of the herbicide, pyraflufenethyl, pyraflufen-ethyl, ethyl 2-chloro-5(4-chloro-5-difluoromethoxy-1-methyl1H-pyrazol-3-yl)-4fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(4-chloro-5difluoromethoxy-1-methyl-1H-pyrazol3-yl)-4-fluorophenoxyacetic acid, in or on: Cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts; sheep, meat byproducts; and milk until December 31, 2016. That document referenced a summary of the petition prepared by Nichino America, Inc., the registrant, which is available to the public in the docket, https:// www.regulations.gov. Comments were received on the notice of filing. EPA’s response to those comments is discussed in Unit IV.C. These tolerances expire on December 31, 2016. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ 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.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.* * *’’ Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pyraflufen-ethyl including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with pyraflufen-ethyl follows. In 2008, the EPA assessed the use of pyraflufen-ethyl on pasture and rangeland grasses. The existing cattle feeding study conducted at the 5X dose was sufficient to establish tolerances for cattle, goat, horse, and sheep meat byproducts and milk; however, since the OPPTS 860.1480 guidelines require that the cattle feeding study be conducted at a 10X dose, the Agency set time-limited tolerances (Federal Register of September 5, 2008 (73 FR 51739) until a new feeding study at the 10X dose could be submitted for permanent tolerances to be established. In the most recent pyraflufen-ethyl tolerance rulemaking, 76 FR 31479 (June 1, 2011) EPA assessed risk of aggregate exposure to pyraflufen-ethyl assuming that exposure occurred in animal meat byproducts and milk at the levels of the established time-limited tolerances. In that action, EPA determined that aggregate risk from exposure was safe. The dietary exposure estimates assumed 100 percent crop treated, so EPA is confident that aggregate dietary exposure is not underestimated and concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children, from aggregate exposure to pyraflufen-ethyl residues. This action to extend time-limited tolerances for animal meat byproducts and milk relies on the assessments supporting the June 1, 2011 rulemaking. These assessments are posted to docket ID, EPA–HQ–OPP– 2010–0426 at https:// www.regulations.gov. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Gas Chromatography with Mass Spectrometry (GC/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever E:\FR\FM\26DER1.SGM 26DER1 75861 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for pyraflufen-ethyl. tkelley on DSK3SPTVN1PROD with C. Response to Comments EPA received one comment to the Notice of Filing that made a general objection to establishing and/or extending tolerances for pesticides. The Agency recognizes that some individuals believe that certain pesticide chemicals should not be permitted in our food. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. When new or amended tolerances are requested for residues of a pesticide in food or feed, the Agency, as is required by section 408 of the FFDCA, estimates the risk of the potential exposure to these residues. The Agency has concluded after this assessment, that there is a reasonable certainty that no harm will result from aggregate human exposure to pyraflufen-ethyl and that, accordingly, the pyraflufen-ethyl temporary tolerances for cattle, goat, horse and sheep meat byproducts, and milk are ‘‘safe’’ and can be extended. V. Conclusion Therefore, time-limited tolerances are extended to December 31, 2016 for residues of pyraflufen-ethyl, pyraflufenethyl, ethyl 2-chloro-5-(4-chloro-5difluoromethoxy-1-methyl-1H-pyrazol3-yl)-4-fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(4chloro-5-difluoromethoxy-1-methyl-1Hpyrazol-3-yl)-4-fluorophenoxyacetic acid, in or on: Cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts; sheep, meat byproducts; and milk. A time limitation has been imposed until a cattle feeding study at VerDate Mar<15>2010 04:58 Dec 22, 2012 Jkt 229001 the 10X dose is found acceptable to support permanent tolerances. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it 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). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do 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. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). 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 final rule. In addition, this final rule does not impose any enforceable PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). 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 of 1995 (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 17, 2012. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.585, revise the following entries in the table in paragraph (a) to read as follows: ■ § 180.585 Pyraflufen-ethyl; tolerances for residues. (a) * * * Commodity * * Cattle, meat byproducts ......... * * * Goat, meat byproducts ......... * * * Horse, meat byproducts ......... Milk .................... * E:\FR\FM\26DER1.SGM 26DER1 Expiration/ Revocation date Parts per million * 0.02 12/31/16 * 0.02 * 12/31/16 * 0.02 0.02 * * 12/31/16 12/31/16 75862 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations * * Sheep, meat byproducts ......... * * * * * 0.02 * * Expiration/ Revocation date Parts per million Commodity * * * 12/31/16 * * * [FR Doc. 2012–31067 Filed 12–21–12; 4:15 pm] Effective Date: This rule will be effective on December 26, 2012. DATES: BILLING CODE 6560–50–P 40 CFR Parts 52 and 81 [EPA–R04–OAR–2012–0327; FRL–9763–8] Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; South Carolina; Redesignation of the CharlotteGastonia-Rock Hill, North CarolinaSouth Carolina 1997 8-Hour Ozone Moderate Nonattainment Area to Attainment Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: EPA is taking final action to approve a request submitted on June 1, 2011, from the State of South Carolina, through the South Carolina Department of Health and Environmental Control (SC DHEC), to redesignate the portion of York County, South Carolina that is within the bi-state Charlotte-GastoniaRock Hill, North Carolina-South Carolina ozone nonattainment area (hereafter referred to as the ‘‘bi-state Charlotte Area,’’ or ‘‘Area’’) to attainment for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS). The bi-state Charlotte Area consists of Cabarrus, Gaston, Lincoln, Mecklenburg, Rowan, Union and a portion of Iredell County (Davidson and Coddle Creek Townships) in North Carolina; and a portion of York County in South Carolina, including the Catawba Indian Nation reservation lands (hereafter referred to as ‘‘the York County Area’’). EPA’s approval of the redesignation request is based on the determination that South Carolina has met the criteria for redesignation to attainment set forth in the Clean Air Act (CAA or Act). Additionally, EPA is approving a revision to the South Carolina State Implementation Plan (SIP) to include the 1997 8-hour ozone maintenance plan for the York County Area that contains the new 2013 and 2022 motor vehicle emission budgets tkelley on DSK3SPTVN1PROD with VerDate Mar<15>2010 04:58 Dec 22, 2012 Jkt 229001 EPA has established a docket for this action under Docket Identification No. EPA–R04–OAR– 2012–0327. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information 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 electronically through www.regulations.gov or in hard copy at the Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303–8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office’s official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal holidays. ADDRESSES: ENVIRONMENTAL PROTECTION AGENCY SUMMARY: (MVEBs) for nitrogen oxides (NOx) and volatile organic compounds (VOC) for the years 2013 and 2022. EPA will take action on the North Carolina submission for the 1997 8-hour ozone redesignation request and maintenance plan for its portion of the bi-state Charlotte Area in a separate action. EPA did not receive comments on the November 15, 2012, proposed rulemaking. FOR FURTHER INFORMATION CONTACT: Jane Spann or Sara Waterson of the Regulatory Development Section, in the Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303–8960. Ms. Spann may be reached by phone at (404) 562–9029, or via electronic mail at spann.jane@epa.gov. Ms. Waterson may be reached by phone at (404) 562–9061, or via electronic mail at waterson.sara@epa.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. What is the background for the actions? II. What are the actions EPA is taking? III. Why is EPA taking these actions? IV. What are the effects of these actions? V. Final Action VI. Statutory and Executive Order Reviews PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 I. What is the background for the actions? On June 1, 2011, South Carolina made a submission to EPA requesting redesignation of the York County Area to attainment for the 1997 8-hour ozone NAAQS and approval of the South Carolina SIP revision containing a maintenance plan for the York County Area. In an action published on November 15, 2012 (77 FR 68087), EPA proposed approval of South Carolina’s plan for maintaining the 1997 8-hour ozone NAAQS and the NOx and VOC MVEBs for the York County Area as contained in the maintenance plan. At that time, EPA also proposed to approve the redesignation of the York County Area to attainment.1 Additional background for today’s action is set forth in EPA’s November 15, 2012, proposal. The MVEBs, specified in kilograms per day (kg/day), included in the maintenance plan are as follows: TABLE 1—YORK COUNTY PORTION OF THE BI-STATE CHARLOTTE AREA NOX AND VOC MVEB [kg/day] 2013 NOX Emissions: Base Emissions ........ Safety Margin Allocated to MVEB ...... NOX Conformity MVEB ................. VOC Emissions: Base Emissions ........ Safety Margin Allocated to MVEB ...... VOC Conformity MVEB ................. 2022 7,924 4,011 3,348 7,357 11,272 11,368 2,846 1,939 853 1,297 3,699 3,236 In its November 15, 2012, proposed action, EPA noted that the adequacy public comment period on these MVEBs (as contained in South Carolina’s submittal) began on October 28, 2011, and closed on November 28, 2011. No comments were received during the public comment period. As stated in the November 15, 2012, proposal, this redesignation addresses the York County Area’s status solely with respect to the 1997 8-hour ozone NAAQS, for which designations were finalized on April 30, 2004. See 69 FR 23857. Effective July 20, 2012, EPA designated a portion of York County 1 On March 7, 2012, at 77 FR 13493, EPA determined that the bi-state Charlotte Area attained the 1997 8-hour ozone NAAQS by its applicable attainment date of June 15, 2011, and that the Area was continuing to attain the ozone standard with monitoring data that was currently available. E:\FR\FM\26DER1.SGM 26DER1

Agencies

[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Rules and Regulations]
[Pages 75859-75862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31067]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0750; FRL-9373-5]


Pyraflufen-Ethyl; Extension of Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends already established time-limited 
tolerances for residues of pyraflufen-ethyl in or on cattle, meat 
byproducts; goat, meat byproducts; horse, meat byproducts; sheep, meat 
byproducts; and milk. Nichino America, Inc. requested the tolerance 
extensions under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 26, 2012. Objections and 
requests for hearings must be received on or before February 25, 2013, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0750, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. 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) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Kathryn Montague, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; email address: 
montague.kathryn@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180

[[Page 75860]]

through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document 
electronically, please go to https://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0750 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
February 25, 2013. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0750, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance Extension

    In the Federal Register of September 28, 2012 (77 FR 59576) (FRL-
9363-8), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F8075 by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, 
Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be 
amended by extending the expiration date for temporary tolerances for 
residues of the herbicide, pyraflufen-ethyl, pyraflufen-ethyl, ethyl 2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(4-
chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetic acid, in or on: Cattle, meat byproducts; goat, meat 
byproducts; horse, meat byproducts; sheep, meat byproducts; and milk 
until December 31, 2016. That document referenced a summary of the 
petition prepared by Nichino America, Inc., the registrant, which is 
available to the public in the docket, https://www.regulations.gov. 
Comments were received on the notice of filing. EPA's response to those 
comments is discussed in Unit IV.C. These tolerances expire on December 
31, 2016.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' 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.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.* * 
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for pyraflufen-ethyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pyraflufen-
ethyl follows.
    In 2008, the EPA assessed the use of pyraflufen-ethyl on pasture 
and rangeland grasses. The existing cattle feeding study conducted at 
the 5X dose was sufficient to establish tolerances for cattle, goat, 
horse, and sheep meat byproducts and milk; however, since the OPPTS 
860.1480 guidelines require that the cattle feeding study be conducted 
at a 10X dose, the Agency set time-limited tolerances (Federal Register 
of September 5, 2008 (73 FR 51739) until a new feeding study at the 10X 
dose could be submitted for permanent tolerances to be established.
    In the most recent pyraflufen-ethyl tolerance rulemaking, 76 FR 
31479 (June 1, 2011) EPA assessed risk of aggregate exposure to 
pyraflufen-ethyl assuming that exposure occurred in animal meat 
byproducts and milk at the levels of the established time-limited 
tolerances. In that action, EPA determined that aggregate risk from 
exposure was safe. The dietary exposure estimates assumed 100 percent 
crop treated, so EPA is confident that aggregate dietary exposure is 
not underestimated and concludes that there is a reasonable certainty 
that no harm will result to the general population, and to infants and 
children, from aggregate exposure to pyraflufen-ethyl residues. This 
action to extend time-limited tolerances for animal meat byproducts and 
milk relies on the assessments supporting the June 1, 2011 rulemaking. 
These assessments are posted to docket ID, EPA-HQ-OPP-2010-0426 at 
https://www.regulations.gov.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas Chromatography with Mass 
Spectrometry (GC/MS)) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever

[[Page 75861]]

possible, consistent with U.S. food safety standards and agricultural 
practices. EPA considers the international maximum residue limits 
(MRLs) established by the Codex Alimentarius Commission (Codex), as 
required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 
United Nations Food and Agriculture Organization/World Health 
Organization food standards program, and it is recognized as an 
international food safety standards-setting organization in trade 
agreements to which the United States is a party. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain the reasons for departing from the 
Codex level. The Codex has not established a MRL for pyraflufen-ethyl.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a 
general objection to establishing and/or extending tolerances for 
pesticides. The Agency recognizes that some individuals believe that 
certain pesticide chemicals should not be permitted in our food. 
However, the existing legal framework provided by section 408 of the 
Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may 
be set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. When new or amended tolerances are requested for residues 
of a pesticide in food or feed, the Agency, as is required by section 
408 of the FFDCA, estimates the risk of the potential exposure to these 
residues. The Agency has concluded after this assessment, that there is 
a reasonable certainty that no harm will result from aggregate human 
exposure to pyraflufen-ethyl and that, accordingly, the pyraflufen-
ethyl temporary tolerances for cattle, goat, horse and sheep meat 
byproducts, and milk are ``safe'' and can be extended.

V. Conclusion

    Therefore, time-limited tolerances are extended to December 31, 
2016 for residues of pyraflufen-ethyl, pyraflufen-ethyl, ethyl 2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(4-
chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetic acid, in or on: Cattle, meat byproducts; goat, meat 
byproducts; horse, meat byproducts; sheep, meat byproducts; and milk. A 
time limitation has been imposed until a cattle feeding study at the 
10X dose is found acceptable to support permanent tolerances.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it 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). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 17, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:


    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.585, revise the following entries in the table in 
paragraph (a) to read as follows:


Sec.  180.585  Pyraflufen-ethyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        date
------------------------------------------------------------------------
 
                                * * * * *
Cattle, meat byproducts.......................         0.02     12/31/16
 
                                * * * * *
Goat, meat byproducts.........................         0.02     12/31/16
 
                                * * * * *
Horse, meat byproducts........................         0.02     12/31/16
Milk..........................................         0.02     12/31/16
 

[[Page 75862]]

 
                                * * * * *
Sheep, meat byproducts........................         0.02     12/31/16
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-31067 Filed 12-21-12; 4:15 pm]
BILLING CODE 6560-50-P
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