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 Environmental Protection Agency 40 CFR Part 180
[EPA-HQ-OPP-2008-0732; FRL-8854-6]
 AGENCY: Environmental Protection Agency (EPA).
 ACTION: Final rule.
 SUMMARY: This regulation establishes tolerances for residues of metrafenone (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl)methanone in or on grapes. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
 DATES: This regulation is effective December 3, 2010. Objections and requests for hearings must be received on or before February 1, 2011, 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-2008-0732. All documents in the docket are listed in the docket index available at 
                        *http://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 
                        *http://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: Tawanda Maignan, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 
                        *telephone number:*
                         (703) 308-8050; 
                        *e-mail address*: 
                        *maignan.tawanda@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 
                    *http://www.gpoaccess.gov/​ecfr.*
                     To access the harmonized test guidelines referenced in this document electronically, please go 
                    *http://www.epa.gov/​ocspp*
                     and select “Test Methods and Guidelines.” 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 identify docket ID number EPA-HQ-OPP-2008-0732 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 1, 2011. 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-2008-0732, by one of the following methods: *Federal eRulemaking Portal:**http://www.regulations.gov.*
                     Follow the on-line 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 October 7, 2009 (74 FR 51599) (FRL-8792-7), 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 8F7371) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.624 be amended by establishing tolerances for residues of the fungicide metrafenone, (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl) methanone, in or on table and wine grapes at 4.5 parts per million (ppm), juice grapes at 0.45 ppm, and raisin grapes at 17 ppm. That notice 
                    ( print page 75390)
                    referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, 
                    *http://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 determined that the proposed tolerances for wine and juice grapes are not needed. The reason for this change is 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 metrafenone including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with metrafenone 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. Metrafenone has low acute toxicity via oral, inhalation and dermal routes. It is not a dermal sensitizer, or a skin or eye irritant. Subchronic and chronic studies showed that the liver was the primary organ affected in toxicity studies with mice, rats and rabbits, along with impacts on body weights and body weight gains. After chronic durations, the liver and body weight effects were accompanied by kidney effects. In the subchronic and chronic toxicity studies in dogs, no effects were seen at any dose, up to 500 milligrams/kilogram/day (mg/kg/day). In developmental toxicity studies in rats and rabbits, there were no effects observed in fetuses at any dose level up to 700 mg/kg/day in rabbits and 1,000 mg/kg/day in rats. The maternal effects in the rabbit developmental study consisted of liver effects as well as decreased body weight gains and food consumption. In the rat developmental toxicity study, no effects were observed in the maternal animals. In the 2-generation reproduction study, there was no evidence of reproductive effects or any impacts on the endocrine system. Effects in parental animals and offspring consisted of decreased body weights and body weight gains, and these were observed at similar doses. In addition, in the parental animals liver effects and decreased thymus weights were observed at the same high doses that resulted in decreased body weight gains. Based on a battery of mutagenicity studies, metrafenone is not considered to be genotoxic. In accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March, 2005), metrafenone is classified as “Suggestive Evidence of Carcinogenicity,” and concluded that human risk to liver tumorgenesis would not be expected at exposure levels that do not cause tumors in mice. The no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) selected for the chronic reference dose (cRfD) are based on hepatotoxicity and nephrotoxicity observed at doses lower than the liver tumor response dose. Thus, the cRfD is protective of the cancer effects. The weight of evidence considerations can be found in the 
                    **Federal Register**
                     of September 20, 2006 (71 FR 54915) (FRL-8093-7). Specific information on the studies received and the nature of the adverse effects caused by metrafenone as well as the NOAEL and the LOAEL from the toxicity studies can be found at 
                    *http://www.regulations.gov*
                     in document 
                    *Metrafenone: Human Health Risk Assessment for Foliar Use on Grapes*
                     in docket ID number EPA-HQ-OPP-2008-0732. 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 the NOAEL and the LOAEL. Uncertainty/safety factors (U/SF) are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) (a = acute c = chronic) 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.* A summary of the toxicological endpoints for Metrafenone used for human risk assessment is shown in Table 1 of this unit. Table 1—Summary of Toxicological Doses and Endpoints for Metrafenone for Use in Human Health Risk Assessment
Exposure/scenario
Point of departure and 
                             uncertainty/safety factors
RfD, PAD, LOC for risk 
                             assessment
Study and toxicological effectsAcute dietary (All populations, including infants and children)
No appropriate endpoint attributable to a single dose identified.( print page 75391)Chronic dietary (All populations,
NOAEL = 24.9 mg/kg/day
Chronic RfD = 0.249 mg/kg/day
Combined Chronic/Carcinogenicity−Ratincluding infants and children).
UFA
                             = 10x
cPAD = 0.249 mg/kg/day
LOAEL = 260 mg/kg/day based onUFH
                             = 10x

hepatotoxicity and nephrotoxicity in bothFQPA SF = 1x

sexes.Cancer (Oral, dermal, inhalation)
**Suggestive evidence of carcinogenicity**
                            . Quantification of cancer risk using a cancer potency factor is not required. The chronic reference dose is protective of potential cancer risk.UFA
                         = extrapolation from animal to human (interspecies). UFH
                         = potential variation in sensitivity among members of the human population (intraspecies). UFL
                         = use of a LOAEL to extrapolate a NOAEL. UFS
                         = use of a short-term study for long-term risk assessment. UFDB
                         = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. LOC = level of concern.
 C. Exposure Assessment 1. 
                    *Dietary exposure from food and feed uses.*
                     In evaluating dietary exposure to metrafenone, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from metrafenone 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 Metrafenone; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. 
                    *Chronic exposure.*
                     In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID, Version 2.03), which incorporates food consumption data as reported by respondents in the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). No Percent Crop Treated (PCT) information was incorporated into the dietary exposure and risk assessment; it was assumed that 100 PCT for grapes. As to residue levels, EPA assumed treated commodities would contain tolerance level residues 2X higher than the proposed tolerances to account for additional residues of potential concern with respect to toxicity which were not included in the proposed tolerance for enforcement purposes. iii. 
                    *Cancer.*
                     EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized and referenced in Unit III.A., EPA has concluded that metrafenone is classified as “Suggestive Evidence of Carcinogenicity.” Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii. 2. 
                    *Dietary exposure from drinking water.*
                     The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for metrafenone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of metrafenone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at 
                    *http://www.epa.gov/​oppefed1/​models/​water/​index.htm.* Based on the First Index Reservoir Screening Tool (FIRST), Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of metrafenone for chronic exposures for non-cancer assessments are estimated to be 22.82 parts per billion (ppb) for surface water and 0.097 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic (non-cancer) dietary risk assessment, the water concentration of value 22.82 ppb was used to assess the contribution to drinking water because the Tier II PRZM/EXAMS value was higher than the Tier I FIRST and groundwater values. 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). Metrafenone is not registered for any specific use patterns that would result in residential exposure. 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 metrafenone to share a common mechanism of toxicity with any other substances, and metrafenone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that metrafenone 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 
                    *http://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 
                    ( print page 75392)
                    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 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.*
                     There is no evidence of increased susceptibility following 
                    *in utero*
                     and/or postnatal exposure in the developmental toxicity studies in rats or rabbits, and in the 2-generation rat reproduction study. 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: i. The toxicity database for metrafenone is complete with the exception of an immunotoxicity study. In accordance with the updated 40 CFR part 158 toxicity data requirements for conventional pesticides, an immunotoxicity study is required for metrafenone. EPA has evaluated the available metrafenone toxicity data to determine whether an additional UFDB
                     is needed to account for the lack of the study. Decreased thymus weight, a potential immunotoxic effect, was observed only in adults and solely in a 2-generation reproduction study in rats. Because this effect was observed in only one species (rats) in one study, at the highest dose tested, and the NOAEL for this effect is 3X higher than the NOAEL for liver toxicity on which the cPAD is based, EPA believes the NOAEL for liver toxicity is protective of this effect, and an additional UFDB
                     is not needed to account for potential immunotoxicity. ii. There is no indication that metrafenone 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 metrafenone 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 residual uncertainties identified in the exposure databases. The dietary food exposure assessments were based on assuming 100 PCT and residues 2X higher than the proposed tolerance residue levels. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to metrafenone in drinking water. These assessments will not underestimate the exposure and risks posed by metrafenone. 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, metrafenone is not expected to pose an acute risk. 2. 
                    *Chronic risk.*
                     Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to metrafenone from food and water will utilize 1% of the cPAD for the general U.S. population and 5% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for metrafenone. 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 there is no residential exposure, metrafenone 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 there is no residential exposure, metrafenone is not expected to pose an intermediate-term risk. 5. 
                    *Aggregate cancer risk for U.S. population.*
                     Based on the data summarized and referenced in Unit III.A., EPA has concluded that the cRfD/cPAD for metrafenone is protective of the cancer effects. As noted above, the chronic exposure for the general U.S. population utilizes only 1% of the cPAD. 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 metrafenone residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate gas chromatography (GC) method with electron capture (ECD) and mass spectrometry (MS) detection, Method FAMS 105-01, is available to enforce the tolerance expression for grapes. However, EPA requires radiovalidation data for any future tolerances on other commodities. Such data were being generated at the time EPA was reviewing the grape submission. 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; 
                    *e-mail 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 metrafenone. Although there has been an agreement to harmonize the proposed grape MRL with Canada, the MRL has yet to be harmonized between member states. C. Revisions to Petitioned-for Tolerances EPA is not establishing the proposed tolerances for wine and juice grapes. Tolerances on raw agricultural commodities (such as grapes) are applicable to food processed from those commodities (such as grape juice and wine). Because the processing data indicate that residues of metrafenone do not concentrate in grape juice or wine, a tolerance on the raw agricultural commodity is all that is necessary. EPA is revising the requested tolerance expression to clarify the chemical moieties that are covered by 
                    ( print page 75393)
                    the tolerances and specify how compliance with the tolerances is to be measured. The revised tolerance expression makes clear that the tolerances cover residues of the fungicide metrafenone, including its metabolites and degradates, but that compliance with the specified tolerance levels is to be determined by measuring only metrafenone (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl)methanone in or on the commodities. V. Conclusion Therefore, tolerances are established for residues of metrafenone, (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl)methanone, in or on grape at 4.5 ppm and grape, raisin at 17 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 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: November 24, 2010. Steven Bradbury, Director, Office of Pesticide Programs.
 Therefore, 40 CFR chapter I is amended as follows: 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. 2.Section 180.624 paragraph (a) is revised to read as follows: § 180.624
  (a) 
                            *General.*
                             Tolerances are established for residues of the fungicide metrafenone, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified in the following table is to be determined by measuring only metrafenone (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl)methanone in or on the following commodities: Commodity
Parts per millionGrape
4.5Grape, raisin
17


[FR Doc. 2010-30363 Filed 12-2-10; 8:45 am] BILLING CODE 6560-50-P