Source: https://www.federalregister.gov/articles/2012/12/26/2012-31067/pyraflufen-ethyl-extension-of-time-limited-pesticide-tolerances
Timestamp: 2016-05-06 07:25:12
Document Index: 193058933

Matched Legal Cases: ['art 178', 'art 180', 'art 178', 'art 178', 'art 2', '§ 180', '§ 180']

Federal Register | Pyraflufen-Ethyl; Extension of Time-Limited Pesticide Tolerances
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).
-75862 (4 pages)
FRL-9373-5
Shorter URL: https://federalregister.gov/a/2012-31067 Related Topics
Pyraflufen-ethyl Request for Time Extension for Cattle, meat byproducts; Goat, meat byproducts; Horse, meat byproducts; Milk; and Sheep, meat byproduct
II. Summary of Petitioned-For Tolerance Extension
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0750, is available at http://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 http://www.epa.gov/dockets.
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&amp;c=ecfr&amp;tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”
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:
II. Summary of Petitioned-For Tolerance Extension Back to Top
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, http://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.
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 http://www.regulations.gov.
Adequate enforcement methodology (Gas Chromatography with Mass Spectrometry (GC/MS)) is available to enforce the tolerance expression.
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.
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.
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.
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.
[FR Doc. 2012-31067 Filed 12-21-12; 4:15 pm]