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Kresoxim-methyl; Pesticide Tolerance
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[Federal Register: August 25, 2006 (Volume 71, Number 165)] [Rules and Regulations] [Page 50354-50359] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25au06-14] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0333; FRL-8088-1] Kresoxim-methyl; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a tolerance for combined residues of kresoxim-methyl in or on vegetable, cucurbit, group 9. Interregional Research Project No. 4 requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective August 25, 2006. Objections and requests for hearings must be received on or before October 24, 2006, 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-2006-0333. All documents in the docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805. FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6463; e-mail address: madden.barbara@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: ? Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. ? Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. ? Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; [[Page 50355]] greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. ? Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides 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 Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2006-0333 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 24, 2006. 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 that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0333, 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 Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket'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 telephone number is (703) 305-5805. II. Background and Statutory Findings In the Federal Register of June 7, 2006 (71 FR 32950) (FRL-8068-1), 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 3E6594) by Interregional Research Project No. 4, Rutgers, the State University of New Jersey, 681 U.S. Highway No. 1, South Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.554 be amended by establishing a tolerance for combined residues of the fungicide kresoxim-methyl (methyl (E)-2-[2-(2-methylphenoxy)-methyl]phenyl-2- (methoxyimido)acetate) and its metabolites as follows: (E)-2-[2-(2- methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid; (E)-2-[2-(2- hydroxymethylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated); and (E)-2-[2-(4-hydroxy-2-methylphenoxy)- methyl]phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated), in or on vegetable, cucurbit, group 9 at 0.5 parts per million (ppm). That notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing. Petition (PP 3E6594) was subsequently amended to lower the residue level for vegetable, cucurbit, group 9 to 0.40 ppm. 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....'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm. III. Aggregate Risk Assessment and Determination of Safety Consistent with 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of kresoxim- methyl on vegetable, cucurbit, group 9 at 0.40 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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. Specific information on the studies received and the nature of the toxic effects caused by kresoxim-methyl 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 http://www.epa.gov/EPA-PEST/1999/June/Day-10/p14761.htm. [[Page 50356]] B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm. A summary of the toxicological endpoints for kresoxim-methyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of June 10, 1999 (64 FR 31129) (FRL- 6085-4) http://www.epa.gov/EPA-PEST/1999/June/Day-10/p14761.htm. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.554) for the combined residues of kresoxim- methyl, in or on a variety of raw agricultural commodities. In addition, tolerances have been established for the residues of the kresoxim-methyl metabolite (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2- (methoxyimido)acetic acid in meat byproducts of cattle, goat, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from kresoxim-methyl 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 one-day or single exposure. No such effects were identified in the toxicological studies for kresoxim-methyl; 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\TM\), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A partially-refined, Tier 3 chronic dietary risk assessment incorporated average field-trial residues for all food commodities, available processing data for grapes, apples, and screening-level percent crop treated (PCT) data for most of the registered commodities. iii. Cancer. In conducting the cancer dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the cancer exposure assessment: A partially-refined, Tier 3 cancer dietary risk assessment incorporated average field-trial residues for all food commodities, available processing data for grapes, apples, and screening-level percent crop treated (PCT) data for most of the registered commodities. iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such data call-ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such data call-ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Apple, 10%; grape, 5%; pear, 5%; and pecan, 1%. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available Federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases < 1% is used as the average and < 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available Federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from United States Department of Agriculture/ National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent 6 years. This method of projecting PCT for a new pesticide, with or without regard to specific pest(s), produces an upper-end projection that is unlikely, in most cases, to be exceeded in actuality in the next 5 years because one or more of the following conditions will likely apply: the dominant pesticide is better established and accepted by farmers than the new pesticide, the dominant pesticide is more efficacious than the new pesticide, the dominant pesticide controls a broader spectrum and/or [[Page 50357]] more important pests than the new pesticide, the dominant pesticide is more cost-effective than the new pesticide, and other conditions. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for kresoxim-methyl in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of kresoxim-methyl. 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. Estimated drinking water concentrations (EDWCs) were calculated for both kresoxim-methyl and (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2- (methoxyimido)acetic acid. Based on the PRZM/EXAMS and SCI-GROW models, the estimated environmental concentrations (EECs) of kresoxim-methyl for chronic exposures are estimated to be 14.91 parts per billion (ppb) for surface water and 6.27 ppb for ground water. The EECs for cancer chronic exposures are estimated to be 7.88 ppb for surface water and 6.27 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID\TM\). Since the surface water EDWCs are higher than the ground water EDWC, the Agency selected these values for use in the dietary assessment. The 1-in-10 year mean of 14.91 ppb was used for the chronic (non-cancer) analysis, and the 30-year mean of 7.88 ppb was used for the cancer analysis. 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). Kresoxim-methyl is not registered for use on any sites that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the 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.'' Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to kresoxim-methyl and any other substances and kresoxim-methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that kresoxim-methyl has 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/ cumulative. Section 408(b)(2)(D)(v) of the 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.'' D. Safety Factor for Infants and Children 1.In general. Section 408 of FFDCA provides that EPA shall apply an additional tenfold 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 data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. In the prenatal developmental toxicity studies in rat and rabbit fetuses, no evidence of developmental toxicity in fetuses was seen at the limit dose. In the 2-generation reproduction study in rats, offspring effects occurred only at parentally toxic dose levels. 3. Conclusion. There is a complete toxicity data base for kresoxim- methyl and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Taking into account the lack of any special pre- or post-natal susceptibility and the completeness of the toxicity and exposure data base, EPA determined that the 10X SF to protect infants and children should be reduced to 1X. E. Aggregate Risks and Determination of Safety 1. Acute risk.An acute risk assessment was not performed. No toxicological endpoint attributable to a single (acute) dietary exposure was identified. Therefore, acute risk from exposure to kresoxim-methyl is not expected. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to kresoxim- methyl from food and water will utilize < 1 % of the cPAD for the U.S. population and all subpopulations including all infants < 1 year old, the subpopulation at greatest exposure. There are no residential uses for kresoxim-methyl. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. Short-and intermediate term risk. Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Kresoxim-methyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 4. Aggregate cancer risk for U.S. population. Using the exposure assumptions described in this unit for cancer exposure, EPA has concluded that the estimated exposure of the general U.S. population to kresoxim-methyl is 0.000234 mg/kg/day. Applying the Q1* of 0.0029 (mg/ kg/day)-1 to the exposure value results in a lifetime cancer risk estimate of 6.80 x 10-7. The EPA considers cancer risk estimates between 1 x 10-6 and 3 x 10-6 to fall within the acceptable range of cancer risk (i.e., less than the range of 10-6); therefore, the cancer risk estimate for kresoxim- methyl is below the Agency's level of concern. 5. 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, and to infants and children [[Page 50358]] from aggregate exposure to kresoxim-methyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (BASF Methods 350/3-US and D9611A are high-performance liquid chromatography (HPLC)/column-switching methods with ultraviolet (UV) detection (270 nm)) are 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; e-mail address: residuemethods@epa.gov. B. International Residue Limits Codex has established maximum residue limits (MRLs) for kresoxim- methyl on various crop commodities. The Codex residue definitions for kresoxim-methyl in plant commodities are in terms of the parent only, and a Codex MRL is established for cucumber at 0.05 ppm. The U.S. and Codex tolerances/MRLs are not compatible with regard to tolerance expression and therefore, the levels can not be harmonized as the recommended tolerance (0.40 ppm) is significantly higher than the Codex MRL (0.05 ppm). V. Conclusion Therefore, the tolerance is established for combined residues of kresoxim-methyl (methyl (E)-2-[2-(2-methylphenoxy)-methyl]phenyl-2- (methoxyimido)acetate) and its metabolites as follows: (E)-2-[2-(2- methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid; (E)-2-[2-(2- hydroxymethylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated); and (E)-2-[2-(4-hydroxy-2-methylphenoxy)- methyl]phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated), in or on vegetable, cucurbit, group 9 at 0.40 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (59 FR 22951, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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: August 16, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. ? Therefore, 40 CFR chapter I is amended as follows: [[Page 50359]] 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 180.554 is amended by alphabetically adding a commodity to the table in paragraph (a)(1) to read as follows: Sec. 180.554 Kresoxim-methyl; tolerances for residues. (a) General. (1) * * * ------------------------------------------------------------------------ Commodity Parts per million ------------------------------------------------------------------------ * * * * * Vegetable, cucurbit, group 9 0.40 ------------------------------------------------------------------------ * * * * * [FR Doc. E6-14165 Filed 8-24-06; 8:45 am] BILLING CODE 6560-50-S