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Emamectin Benzoate; Pesticide 112) 18504 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations § 218.32 Objection time periods. Friday, excluding legal holidays. The hearing requests are provided in 40 CFR (a) Time to file an objection. Written telephone number for the Public 178.25(b). objections, including any attachments, Reading Room is (202) 566–1744, and In addition to filing an objection or must be filed with the reviewing officer the telephone number for the OPP hearing request with the Hearing Clerk within 30 days following the Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please publication date of the legal notice of the visitor instructions and additional submit a copy of the filing (excluding the EA or final EIS in the newspaper of information about the docket available any Confidential Business Information record or the publication date of the at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. notice in the Federal Register when the FOR FURTHER INFORMATION CONTACT: Information not marked confidential Chief is the responsible official (see Andrew Ertman, Registration Division pursuant to 40 CFR part 2 may be § 218.6(c)). It is the responsibility of (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior objectors to ensure that their objection Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your is received in a timely manner. Pennsylvania Ave. NW., Washington, objection or hearing request, identified (b) Time for responding to an DC 20460–0001; telephone number: by docket ID number EPA–HQ–OPP– objection. The reviewing officer must (703) 308–9367; email address: 2011–0665, by one of the following issue a written response to the [email protected]. methods: • Federal eRulemaking Portal: http:// objector(s) concerning their objection(s) SUPPLEMENTARY INFORMATION: within 30 days following the end of the www.regulations.gov. Follow the online objection filing period. I. General Information instructions for submitting comments. Do not submit electronically any Dated: March 20, 2013. A. Does this action apply to me? information you consider to be Harris D. Sherman, You may be potentially affected by Confidential Business Information (CBI) Under Secretary, Natural Resources and this action if you are an agricultural or other information whose disclosure is Environment (NRE). producer, food manufacturer, or restricted by statute. • [FR Doc. 2013–06857 Filed 3–26–13; 8:45 am] pesticide manufacturer. The following Mail: OPP Docket, Environmental BILLING CODE 3410–11–P list of North American Industrial Protection Agency Docket Center (EPA/ Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. not intended to be exhaustive, but rather • ENVIRONMENTAL PROTECTION provides a guide to help readers Hand Delivery: To make special AGENCY determine whether this document arrangements for hand delivery or applies to them. Potentially affected delivery of boxed information, please 40 CFR Part 180 entities may include: follow the instructions at http:// • Crop production (NAICS code 111). www.epa.gov/dockets/contacts.htm. [EPA–HQ–OPP–2011–0665; FRL–9381–4] • Animal production (NAICS code Additional instructions on commenting or visiting the docket, along with more Emamectin Benzoate; Pesticide 112). • information about dockets generally, is Tolerance Food manufacturing (NAICS code 311). available at http://www.epa.gov/ AGENCY: Environmental Protection • Pesticide manufacturing (NAICS dockets. Agency (EPA). code 32532). II. Summary of Petitioned-For ACTION: Final rule. B. How can I get electronic access to Tolerance other related information? SUMMARY: This regulation establishes a In the Federal Register of September tolerance for residues of emamectin You may access a frequently updated 7, 2011 (76 FR 55329) (FRL–8886–7), benzoate in or on the cucurbit vegetable electronic version of EPA’s tolerance EPA issued a document pursuant to crop group 9. Interregional Research regulations at 40 CFR part 180 through FFDCA section 408(d)(3), 21 U.S.C. Project Number 4 (IR–4) requested this the Government Printing Office’s e-CFR 346a(d)(3), announcing the filing of a tolerance under the Federal Food, Drug, site at http://www.ecfr.gov/cgi-bin/text- pesticide petition (PP 1E7904) by IR–4, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 500 College Rd. East, Suite 201 W, 40tab_02.tpl. Princeton, NJ 08540. The petition DATES: This regulation is effective requested that 40 CFR 180.505 be March 27, 2013. Objections and requests C. How can I file an objection or hearing amended by establishing tolerances for for hearings must be received on or request? residues of the insecticide emamectin before May 28, 2013, and must be filed Under FFDCA section 408(g), 21 benzoate, 4′-epimethylamino-4′- in accordance with the instructions U.S.C. 346a, any person may file an deoxyavermectin B1 benzoate (a provided in 40 CFR part 178 (see also objection to any aspect of this regulation mixture of a minimum of 90% 4′-epi- Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those methylamino-4′-deoxyavermectin B1a INFORMATION). objections. You must file your objection and a maximum of 10% 4′-epi- ADDRESSES: The docket for this action, or request a hearing on this regulation methlyamino-4′deoxyavermectin B1b identified by docket identification (ID) in accordance with the instructions benzoate), and its metabolites 8,9 isomer number EPA–HQ–OPP–2011–0665, is provided in 40 CFR part 178. To ensure of the B1a and B1b component of the available at http://www.regulations.gov proper receipt by EPA, you must parent insecticide, in or on vegetable, or at the Office of Pesticide Programs identify docket ID number EPA–HQ– cucurbit, group 9 at 0.03 parts per Regulatory Public Docket (OPP Docket) OPP–2011–0665 in the subject line on million (ppm). That document in the Environmental Protection Agency the first page of your submission. All referenced a summary of the petition Docket Center (EPA/DC), EPA West objections and requests for a hearing prepared by Syngenta, the registrant, Bldg., Rm. 3334, 1301 Constitution Ave. must be in writing, and must be which is available in the docket, http:// NW., Washington, DC 20460–0001. The received by the Hearing Clerk on or www.regulations.gov. There were no Public Reading Room is open from 8:30 before May 28, 2013. Addresses for mail comments received in response to the a.m. to 4:30 p.m., Monday through and hand delivery of objections and notice of filing. VerDate Mar<15>2010 15:14 Mar 26, 2013 Jkt 229001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\FR\FM\27MRR1.SGM 27MRR1 erowe on DSK2VPTVN1PROD with RULES Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations 18505 Based upon review of the data potential to influence GABA-mediated degeneration in the brain and in supporting the petition, EPA has events important to brain development. peripheral nerves, muscle fiber modified the level at which the Within the mammalian brain, a member degeneration) were found in most of the tolerance is being established. The of this class of compound (abamectin) emamectin studies in rats, dogs and reason for this change is explained in has been shown to have widespread mice. The dose/response curve was very Unit IV.C. binding but particularly abundant in the steep in several studies (most notably cerebellum. Through action on the with CF-1 mice and dogs), with severe III. Aggregate Risk Assessment and enteric nervous system and induction of effects (morbid sacrifice and Determination of Safety longitudinal rhythmic contractions in neuropathology) sometimes seen at the Section 408(b)(2)(A)(i) of FFDCA the isolated ileum, emamectin like LOAELs (0.1 milligram/kilogram/day allows EPA to establish a tolerance (the abamectin may therefore influence (mg/kg/day) with NOAEL of 0.075 mg/ legal limit for a pesticide chemical GABA-mediated regulation of kg/day). Although no increased residue in or on a food) only if EPA metabolism, food intake and body sensitivity was seen in developmental determines that the tolerance is ‘‘safe.’’ weight at multiple sites. Although toxicity studies in rats and rabbits, Section 408(b)(2)(A)(ii) of FFDCA GABA receptor mediated neurotoxicity increased qualitative and/or quantitative defines ‘‘safe’’ to mean that ‘‘there is a is a solid hypothesis, data in sensitivity of rat pups was seen in the reasonable certainty that no harm will mammalian preparations linking reproductive toxicity and in the result from aggregate exposure to the alterations in GABA receptor function to developmental neurotoxicity studies. pesticide chemical residue, including disruptions in neuronal excitability in The carcinogenicity and mutagenicity all anticipated dietary exposures and all vitro and in vivo, and ultimately adverse studies provide no indication that other exposures for which there is outcome are currently lacking. emamectin is carcinogenic or reliable information.’’ This includes Integral to its mechanism of action in mutagenic. Emamectin is classified as exposure through drinking water and in mammals, this class of compounds is ‘‘not likely to be carcinogenic to residential settings, but does not include also a substrate for (i.e., binds to) P- humans.’’ occupational exposure. Section glycoprotein. P-glycoprotein (P-gp) is a The available emamectin data show 408(b)(2)(C) of FFDCA requires EPA to member of the adenosine triphosphate that there is a difference in species give special consideration to exposure (ATP) binding cassette transporter sensitivity, and the data suggest the of infants and children to the pesticide proteins, which reside in the plasma following order: Rat NOAELs/LOAELs chemical residue in establishing a membrane and function as a greater than dog NOAELs/LOAELs tolerance and to ‘‘ensure that there is a transmembrane efflux pump, moving greater than mouse NOAELs/LOAELs.
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