AGENCY:

ACTION:

SUMMARY:

This regulation is effective October 25, 2016. Objections and requests for hearings must be received on or before December 27, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 FOR FURTHER INFORMATION CONTACT:

RDFRNotices@epa.gov

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:

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

  You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl a, 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-2015-0679 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 December 27, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25 http://www.regulations.gov Follow the online Start Printed Page 73343 Mail: Hand Delivery: http://www.epa.gov/dockets/contacts.html II. Summary of Petitioned-for Tolerance

  of May 19, 2016 ( 81 FR 31581 ) (FRL-9946-02), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346 a(d)(3), announcing the filing of a pesticide petition (PP 5E8376) by Bayer CropScience LP, P.O. Box 12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.641 http://www.regulations.gov A comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

  In one- and two-generation rat reproductive toxicity studies, male reproductive toxicity (abnormal sperm cells and reproductive performance) similar to that reported in subchronic toxicity studies with adult rats was reported in the first generation (F 1 in the document titled �� Spirotetramat. Human Health Risk Assessment for the Petition for a Tolerance for Residues in/on Asparagus Without a U.S. Registration�� POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level��generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)��and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm

  Table 1��Summary of Toxicological Doses and Endpoints for Spirotetramat for Use in Human Health Risk Assessment

  Exposure/scenario Point of departure and uncertainty/ safety factors A = 10x UF H = 10x FQPA SF = 1xAcute RfD = 1.0 mg/kg/day aPAD = 1.0 mg/kg/day.Acute neurotoxicity (rat). LOAEL = 200 mg/kg based on clinical signs and decreased motor activity in males. A = 10x UF H = 10x FQPA SF = 1xChronic RfD = 0.05 mg/kg/day cPAD = 0.05 mg/kg/day.Chronic toxicity (dog). LOAEL = 20 mg/kg/day based on thymus involution in males. Cancer (Oral, dermal, inhalation) FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies).