Ametoctradin; Pesticide Tolerances, 27130-27134 [2012-10950]

Download as PDF 27130 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations Inert ingredients * * Limits * 3. Section 180.930 is amended by revising the following entries in the * * * * § 180.930 Inert ingredients applied to animas; exemptions from the requirement of a tolerance. table of inert ingredients to read as follows: ■ Uses * * * * * Inert ingredients Limits * * * * a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, potassium, sodium, and zinc salts of the phosphate esters; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4– 14 or 30 moles (CAS Reg. Nos. 51811–79–1, 59139–23–0, 67922–57–0, 68412– 53–3, 68553–97–9, 68954–84–7, 99821–14–4, 152143–22–1, 51609–41–7, 37340–60–6, 106151–63–7, 68584–47–4, 52503–15–8, 68458–49–1). a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts the nonyl group is propylene trimer isomer and the poly(oxyethylene) content averages 4 moles (CAS Reg. Nos. 9014– 90–8, 9051–57–4, 9081–17–8, 68649–55–8, 68891–33–8. * * Not to exceed 7% of pesticide formulation. * Surfactants, related adjuvants of surfactants. Not to exceed 7% of pesticide formulation. Surfactants, related adjuvants of surfactants. * * * [FR Doc. 2012–10933 Filed 5–8–12; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2010–0261; FRL–9339–6] Ametoctradin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of ametoctradin in or on multiple commodities which are identified and discussed later in this document. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 9, 2012. Objections and requests for hearings must be received on or before July 9, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2010–0261. All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose sroberts on DSK5SPTVN1PROD with RULES ADDRESSES: VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 * * 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 in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Shaunta Hill, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 347–8961; email address: hill.shaunta@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. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). PO 00000 Frm 00018 Fmt 4700 Uses Sfmt 4700 * * • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. 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 https://ecfr.gpoaccess.gov/cgi/t/ text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ Title40/40tab_02.tpl. 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 E:\FR\FM\09MYR1.SGM 09MYR1 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations sroberts on DSK5SPTVN1PROD with RULES identify docket ID number EPA–HQ– OPP–2010–0261 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 July 9, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2010–0261, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Summary of Petitioned-for Tolerance In the Federal Register of May 19, 2010 (75 FR 28009) (FRL–8823–2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7695) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide ametoctradin, including its metabolites and degradates, in or on brassica, head and stem, subgroup 5A at 12 parts per million (ppm); brassica, leafy greens, subgroup 5B at 50 ppm; grape at 5.0 ppm; grape, raisin at 8 ppm; hop, dried cones at 9 ppm; onion, bulb, subgroup 3–07A at 1.2 ppm; onion, green, subgroup 3–07B at 16 ppm; vegetable, cucurbit, group 9 at 4.5 ppm; vegetable, fruiting, group 8–10 at 2 ppm; vegetable, leafy, except brassica, group 4, at 70 VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 ppm, and vegetable, tuberous and corm, subgroup 1C at 0.05 ppm. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has proposed different tolerance levels under a cooperative global review process. The reason for these changes are explained in Unit IV.D. 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 ametoctradin including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with ametoctradin follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In toxicity testing with ametoctradin, no single dose or repeated dose study PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 27131 performed by any route of exposure produced a significant toxic effect up to or within 75–80% of the limit dose (1000 mg/kg/day). This includes the studies performed with the ametoctradin metabolites. There was also no evidence of carcinogenicity or mutagenicity and therefore ametoctradin is considered ‘‘Not Likely to Be Carcinogenic to Humans’’. Specific information on the studies received and the nature of the adverse effects caused by ametoctradin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document ‘‘BAS 650 F (Ametoctradin): Human Health Risk Assessment for the Proposed New Fungicide Active Ingredient,’’ at p. 10 in docket ID number EPA–HQ–OPP–2010– 0261. B. Toxicological Points of Departure/ Levels of Concern 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 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 https://www.epa. gov/pesticides/factsheets/ riskassess.htm. Based on the available data, there were no adverse acute or chronic effects identified as to any population groups (including infants and children). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary E:\FR\FM\09MYR1.SGM 09MYR1 sroberts on DSK5SPTVN1PROD with RULES 27132 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations exposure to ametoctradin, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from ametoctradin in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for ametoctradin; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. No chronic dietary exposure assessment was conducted because no chronic effect of concern was identified in the available data. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that ametoctradin does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. 2. Dietary exposure from drinking water. Exposure to ametoctradin via drinking water from the proposed uses is expected to be minimal based on its short half life in soil. Ametoctradin degradates (F01, F02, F03, F04) are likely to contribute much greater drinking water exposure because they are more persistent and more mobile than the parent. However, no adverse effects were observed in the submitted toxicological studies for ametoctradin regardless of the route of exposure. Thus, no drinking water exposure assessments are needed. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Ametoctradin is not registered for homeowner uses; however, some of the proposed uses could be used by commercial applicators in areas that residential postapplication exposure could occur (i.e., ornamentals on golf courses or in residential landscapes). No adverse effects were observed in the submitted toxicological studies for ametoctradin regardless of the route of exposure. Thus, no residential handler or postapplication exposure assessments are needed. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found ametoctradin to share a common mechanism of toxicity with any other substances, and ametoctradin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ametoctradin does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at https://www.epa.gov/pesticides/ cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Based on the complete database, there were no adverse effects noted in the developmental toxicity or reproductive toxicity studies. 3. Conclusion. Based on review of the available ametoctradin toxicological studies, no toxicological points of departure where selected for ametoctradin and thus, an additional safety factor to protect children is not needed. That decision is based on the following findings: i. The toxicity database for ametoctradin is complete. ii. There is no indication that ametoctradin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that ametoctradin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 in young rats in the 2-generation reproduction study. iv. There are no concerns identified with regard to exposure to ametoctradin and thus there are no uncertainties identified in the exposure databases. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, ametoctradin is not expected to pose an acute risk. 2. Chronic risk. No adverse effect resulting from a chronic exposure was identified and no chronic endpoint was selected. Therefore, ametoctradin is not expected to pose a chronic risk. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no short-term adverse effect was identified, ametoctradin is not expected to pose a short-term risk. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, ametoctradin is not expected to pose a intermediateterm risk. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, ametoctradin is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to ametoctradin residues. E:\FR\FM\09MYR1.SGM 09MYR1 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology using liquid chromatography tandem mass spectrometry (LC/MS/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. sroberts on DSK5SPTVN1PROD with RULES B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever 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 U.N. 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 ametoctradin. C. Revisions to Petitioned-for Tolerances Ametoctradin is a candidate for global registration in the USA, Australia, and Canada and import tolerance establishment in the European Union (EU) for varying uses. Under a cooperative joint review process, harmonized MRLs were proposed by the Agency, the Pesticide Management Regulatory Agency of Canada (PMRA), and the EU. Although much effort was made to harmonize with the EU proposed import-MRLs, there remained a few crops (celery, broccoli, cucumber and hops) where the proposed global registration recommended MRLs differed. This is primarily because EU’s practice for setting MRLs is to lower the MRL as much as possible hence they try to assign MRLs to selected individual crops within a crop group as opposed to assigning a crop group MRL which is normally higher than all the estimated MRLs for individual crops. This approach is impractical for North American Free Trade Agreement (NAFTA) regions as there are other VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 crops within a crop group petitioned for registration. The Organization for Economic Cooperation and Development’s (OECD) MRL calculation procedures used to estimate the proposed MRLs. The MRLs were derived using the average of individual residue data points from each field trial conducted at maximum applications rates and the lowest PHI, and assuming the presence of adjuvants (as indicated on the proposed labels). In estimating MRLs for crop groups, the highest estimated MRL for individual representative crops were selected. For some crops, field trials were conducted at concentrated and diluted solutions. In these cases, MRLs were chosen using only the residue data for applications with concentrated solution if the concentrated solution residue data showed significant differences from the whole residue dataset (concentrated and diluted solution applications). V. Conclusion Therefore, tolerances are established for residues of ametoctradin, including its metabolites and degradates, in or on brassica, head and stem, subgroup 5A at 9.0 ppm; brassica, leafy greens, subgroup 5B at 50 ppm; grape at 4.0 ppm; grape, raisin at 8.0 ppm; hop, dried cones at 10 ppm; onion, bulb, subgroup 3–07A at 1.5 ppm; onion, green, subgroup 3–07B at 20 ppm; spinach at 50 ppm; vegetable, cucurbit, group 9 at 3.0 ppm; vegetable, fruiting, group 8–10 at 1.5 ppm; vegetable, leafy, except brassica, group 4, except spinach at 40 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.05 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA 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 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 27133 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4). 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), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register. This final rule is not E:\FR\FM\09MYR1.SGM 09MYR1 27134 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations § 180.663 Ametoctradin; tolerances for residues. 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: April 27, 2012. Steven Bradbury, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: (a) General. Tolerances are established for residues of the fungicide ametoctradin, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only ametoctradin (5-ethyl-6octyl[1,2,4]triazolo[1,5-a]pyrimidin-7amine). Parts per million Commodity 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. sroberts on DSK5SPTVN1PROD with RULES ■ 2. Add § 180.663 to read as follows: VerDate Mar<15>2010 15:36 May 08, 2012 Jkt 226001 Commodity Brassica, head and stem, subgroup 5A ................................. Brassica, leafy greens, subgroup 5B ............................................ Grape .......................................... Grape, raisin ............................... PO 00000 Frm 00022 Fmt 4700 Sfmt 9990 9.0 50 4.0 8.0 Parts per million Hop, dried cones ........................ Onion, bulb, subgroup 3–07A .... Onion, green, subgroup 3–07B .. Spinach ....................................... Vegetable, cucurbit, group 9 ...... Vegetable, fruiting, group 8–10 .. Vegetable, leafy, except Brassica, group 4, except spinach Vegetable, tuberous and corm, subgroup 1C ........................... 10.0 1.5 20.0 50.0 3.0 1.5 40.0 0.05 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 2012–10950 Filed 5–8–12; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\09MYR1.SGM 09MYR1

Agencies

[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Rules and Regulations]
[Pages 27130-27134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10950]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0261; FRL-9339-6]


Ametoctradin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
ametoctradin in or on multiple commodities which are identified and 
discussed later in this document. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 9, 2012. Objections and 
requests for hearings must be received on or before July 9, 2012, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0261. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
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 in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Shaunta Hill, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8961; email address: hill.shaunta@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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 https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

[[Page 27131]]

identify docket ID number EPA-HQ-OPP-2010-0261 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 July 9, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0261, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 0F7695) 
by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC. The 
petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the fungicide ametoctradin, including its 
metabolites and degradates, in or on brassica, head and stem, subgroup 
5A at 12 parts per million (ppm); brassica, leafy greens, subgroup 5B 
at 50 ppm; grape at 5.0 ppm; grape, raisin at 8 ppm; hop, dried cones 
at 9 ppm; onion, bulb, subgroup 3-07A at 1.2 ppm; onion, green, 
subgroup 3-07B at 16 ppm; vegetable, cucurbit, group 9 at 4.5 ppm; 
vegetable, fruiting, group 8-10 at 2 ppm; vegetable, leafy, except 
brassica, group 4, at 70 ppm, and vegetable, tuberous and corm, 
subgroup 1C at 0.05 ppm. That notice referenced a summary of the 
petition prepared by BASF Corporation, the registrant, which is 
available in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
proposed different tolerance levels under a cooperative global review 
process. The reason for these changes are explained in Unit IV.D.

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 ametoctradin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with ametoctradin 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    In toxicity testing with ametoctradin, no single dose or repeated 
dose study performed by any route of exposure produced a significant 
toxic effect up to or within 75-80% of the limit dose (1000 mg/kg/day). 
This includes the studies performed with the ametoctradin metabolites. 
There was also no evidence of carcinogenicity or mutagenicity and 
therefore ametoctradin is considered ``Not Likely to Be Carcinogenic to 
Humans''.
    Specific information on the studies received and the nature of the 
adverse effects caused by ametoctradin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``BAS 650 F (Ametoctradin): Human 
Health Risk Assessment for the Proposed New Fungicide Active 
Ingredient,'' at p. 10 in docket ID number EPA-HQ-OPP-2010-0261.

 B. Toxicological Points of Departure/Levels of Concern

    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 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm. Based on the available data, 
there were no adverse acute or chronic effects identified as to any 
population groups (including infants and children).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary

[[Page 27132]]

exposure to ametoctradin, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from ametoctradin in 
food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for ametoctradin; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. No chronic dietary exposure assessment was 
conducted because no chronic effect of concern was identified in the 
available data.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that ametoctradin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. Exposure to ametoctradin 
via drinking water from the proposed uses is expected to be minimal 
based on its short half life in soil. Ametoctradin degradates (F01, 
F02, F03, F04) are likely to contribute much greater drinking water 
exposure because they are more persistent and more mobile than the 
parent. However, no adverse effects were observed in the submitted 
toxicological studies for ametoctradin regardless of the route of 
exposure. Thus, no drinking water exposure assessments are needed.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Ametoctradin is not 
registered for homeowner uses; however, some of the proposed uses could 
be used by commercial applicators in areas that residential 
postapplication exposure could occur (i.e., ornamentals on golf courses 
or in residential landscapes). No adverse effects were observed in the 
submitted toxicological studies for ametoctradin regardless of the 
route of exposure. Thus, no residential handler or postapplication 
exposure assessments are needed.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. 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.''
    EPA has not found ametoctradin to share a common mechanism of 
toxicity with any other substances, and ametoctradin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
ametoctradin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. Based on the complete 
database, there were no adverse effects noted in the developmental 
toxicity or reproductive toxicity studies.
    3. Conclusion. Based on review of the available ametoctradin 
toxicological studies, no toxicological points of departure where 
selected for ametoctradin and thus, an additional safety factor to 
protect children is not needed. That decision is based on the following 
findings:
    i. The toxicity database for ametoctradin is complete.
    ii. There is no indication that ametoctradin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that ametoctradin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no concerns identified with regard to exposure to 
ametoctradin and thus there are no uncertainties identified in the 
exposure databases.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
ametoctradin is not expected to pose an acute risk.
    2. Chronic risk. No adverse effect resulting from a chronic 
exposure was identified and no chronic endpoint was selected. 
Therefore, ametoctradin is not expected to pose a chronic risk.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Because no 
short-term adverse effect was identified, ametoctradin is not expected 
to pose a short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term adverse effect was identified, 
ametoctradin is not expected to pose a intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, ametoctradin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to ametoctradin residues.

[[Page 27133]]

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology using liquid chromatography tandem 
mass spectrometry (LC/MS/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 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 U.N. 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 ametoctradin.

C. Revisions to Petitioned-for Tolerances

    Ametoctradin is a candidate for global registration in the USA, 
Australia, and Canada and import tolerance establishment in the 
European Union (EU) for varying uses. Under a cooperative joint review 
process, harmonized MRLs were proposed by the Agency, the Pesticide 
Management Regulatory Agency of Canada (PMRA), and the EU.
    Although much effort was made to harmonize with the EU proposed 
import-MRLs, there remained a few crops (celery, broccoli, cucumber and 
hops) where the proposed global registration recommended MRLs differed. 
This is primarily because EU's practice for setting MRLs is to lower 
the MRL as much as possible hence they try to assign MRLs to selected 
individual crops within a crop group as opposed to assigning a crop 
group MRL which is normally higher than all the estimated MRLs for 
individual crops. This approach is impractical for North American Free 
Trade Agreement (NAFTA) regions as there are other crops within a crop 
group petitioned for registration.
    The Organization for Economic Co-operation and Development's (OECD) 
MRL calculation procedures used to estimate the proposed MRLs. The MRLs 
were derived using the average of individual residue data points from 
each field trial conducted at maximum applications rates and the lowest 
PHI, and assuming the presence of adjuvants (as indicated on the 
proposed labels). In estimating MRLs for crop groups, the highest 
estimated MRL for individual representative crops were selected.
    For some crops, field trials were conducted at concentrated and 
diluted solutions. In these cases, MRLs were chosen using only the 
residue data for applications with concentrated solution if the 
concentrated solution residue data showed significant differences from 
the whole residue dataset (concentrated and diluted solution 
applications).

 V. Conclusion

    Therefore, tolerances are established for residues of ametoctradin, 
including its metabolites and degradates, in or on brassica, head and 
stem, subgroup 5A at 9.0 ppm; brassica, leafy greens, subgroup 5B at 50 
ppm; grape at 4.0 ppm; grape, raisin at 8.0 ppm; hop, dried cones at 10 
ppm; onion, bulb, subgroup 3-07A at 1.5 ppm; onion, green, subgroup 3-
07B at 20 ppm; spinach at 50 ppm; vegetable, cucurbit, group 9 at 3.0 
ppm; vegetable, fruiting, group 8-10 at 1.5 ppm; vegetable, leafy, 
except brassica, group 4, except spinach at 40 ppm; and vegetable, 
tuberous and corm, subgroup 1C at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule is not

[[Page 27134]]

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: April 27, 2012.
Steven Bradbury,
Director, 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. Add Sec.  180.663 to read as follows:


Sec.  180.663  Ametoctradin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide ametoctradin, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only ametoctradin (5-ethyl-6-octyl[1,2,4]triazolo[1,5-
a]pyrimidin-7-amine).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................         9.0
Brassica, leafy greens, subgroup 5B.........................          50
Grape.......................................................         4.0
Grape, raisin...............................................         8.0
Hop, dried cones............................................        10.0
Onion, bulb, subgroup 3-07A.................................         1.5
Onion, green, subgroup 3-07B................................        20.0
Spinach.....................................................        50.0
Vegetable, cucurbit, group 9................................         3.0
Vegetable, fruiting, group 8-10.............................         1.5
Vegetable, leafy, except Brassica, group 4, except spinach..        40.0
Vegetable, tuberous and corm, subgroup 1C...................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-10950 Filed 5-8-12; 8:45 am]
BILLING CODE 6560-50-P
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