美国修订四聚乙醛（Metaldehyde）在蔬菜、谷物中的残留限量要汁�/h1>

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2016-10-28 03:58:02 来源９�a href="https://www.federalregister.gov/documents/2016/10/18/2016-25166/metaldehyde-pesticide-tolerances" target="_blank" rel="nofollow">美国联邦公报浏览次数９�span id="hits">10906

核心提示�?016�?0�?8日，美国环境保护署发布条例，修订四聚乙醛（Metaldehyde）在蔬菜和谷物中的残留限量要求、�/div>

发布单位	美国环境保护� 美国环境保护罱�/div>	发布文号	81 FR 71633
发布日期	2016-10-18	生效日期	2016-10-18
有效性状�?/th>		废止日期	暂无
属�?/th>	法规	专业属�?/th>	限量相关
备注	2016�?0�?8日，美国环境保护署发布条例，修订四聚乙醛（Metaldehyde）在蔬菜和谷物中的残留限量要求，具体限量要求为：菜用甜菜叶中残留限量�?..08ppm，菜用甜菜根中残留限量为0.05ppm，干燥啤酒花中残留限量为0.10ppm，大头菜根残留限量为0.05ppm，萝卜叶中残留限量为0.08ppm，萝卜根中残留限量为0.05ppm，饲用小麦、小麦粒、小麦干草和麦秸中残留限量均�?.05ppm。本条例自发布之日起生效，如有反对意见或请求听证，须按照40 CFR part 178中相关规定，�?016�?2�?9日之前提出、�/td>

ACTION:

SUMMARY:

This regulation is effective October 18, 2016. Objections and requests for hearings must be received on or before December 19, 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-2015-0558 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 19, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25 http://www.regulations.gov Mail: Hand Delivery: http://www.epa.gov/dockets/contacts.html II. Summary of Petitioned-For Tolerance

  of Wednesday, September 9, 2015 ( 80 FR 54257 ) (FRL-9933-26), 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 5E8377) by Interregional Research Project Number 4 (IR-4), IR-4 Headquarters, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR 180.523 be amended by establishing tolerances for residues of the molluscicide metaldehyde, 2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on beet, garden, roots at 0.05 parts per million (ppm); beet, garden, tops at 0.08 ppm; hop, dried cones at 0.05 ppm; rutabaga, roots at 0.05 ppm; turnip, greens (tops) at 0.08 ppm; turnip, roots at 0.05 ppm; wheat, forage at 0.05 ppm; wheat, grain at 0.05 ppm; wheat, hay at 0.05 ppm and wheat, straw at 0.05 ppm. That document referenced a summary of the petition prepared by Lonza, Inc., the registrant, which is available in the docket, http://www.regulations.gov Based upon review of the data supporting the petition, EPA has made certain modifications to the petitioned-for crop tolerances. The reason for these changes are explained in Unit IV.C.

  The toxicity profile of metaldehyde shows that the principal toxic effects are clinical signs of neurotoxicity. The dog is the most sensitive species for the neurotoxic effects. The nervous system effects observed in subchronic and chronic oral toxicity studies include: (1) Neurotoxic signs, i.e., The liver is a target organ following subchronic and chronic oral exposure to metaldehyde as evidenced by increased liver weight, increased incidence of liver lesions, i.e., Developmental toxicity was not observed in the rat or rabbit developmental toxicity studies. Maternal toxicity was not observed in the rabbit, although maternal toxicity was observed in the rat, as evidenced by clinical signs including ataxia, tremors, and twitching at the highest dose tested (HDT). In the rat reproductive toxicity study, mortality and clinical signs, i.e., Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological 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 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 PAD or a 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides A summary of the toxicological endpoints for metaldehyde used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of November 27, 2013 ( 78 FR 70864 C. Exposure Assessment

  i. Acute exposure. iii. Cancer. 3. From non-dietary exposure. For children, the highest estimated metaldehyde exposure resulted from post-application incidental oral exposures of short-term duration from hand-to-mouth and object-to-mouth contact with treated turf, and short- and intermediate-term exposures from treated soil. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ��available information�� concerning the cumulative effects of a particular pesticide's residues and ��other substances that have a common mechanism of toxicity.��

  http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides D. Safety Factor for Infants and Children

  Developmental toxicity was not observed in the rat or rabbit developmental toxicity studies and no maternal toxicity observed in the rabbit. Maternal toxicity was observed in the rat, as evidenced by clinical signs, i.e., ataxia, tremors, and twitching, however these effects were observed only at the highest dose tested. In the rat reproductive toxicity study, mortality and clinical signs, i.e., 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings:

  3. Short-term risk: A. Analytical Enforcement Methodology

  TM residuemethods@epa.gov B. International Residue Limits

  C. Revisions to Petitioned-for Tolerances

  V. Conclusion