[Federal Register Volume 75, Number 169 (Wednesday, September 1, 2010)] [Rules and Regulations] [Pages 53581-53586] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2010-21686] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2009-0682; FRL-8841-9] Spiromesifen; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of spiromesifen in or on leaf petioles subgroup 4B, dry pea seed, spearmint tops, and peppermint tops. The Interregional Research Project Number 4 (IR-4) and Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 1, 2010. Objections and requests for hearings must be received on or before November 1, 2010, 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-2009-0682. 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: Andrew Ertman, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9367; e-mail address: [email protected]. 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. 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 53582]] identify docket ID number EPA-HQ-OPP-2009-0682 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 November 1, 2010. 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-2009-0682, 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 March 24, 2010 (75 FR 14156) (FRL-8815- 6), 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) 0E7684 by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540 and PP 9F7602 by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petitions requested that 40 CFR 180.607 be amended by establishing tolerances for residues of the insecticide spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1- oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate, and its enol metabolite, 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3- en-2-one, calculated as parent compound equivalents, in or on pea, dry, seed at 0.15 parts per million (ppm); spearmint, tops at 25 ppm; and peppermint, tops at 25 ppm (PP 0E7684) and vegetable, leafy petiole, crop subgroup 4B at 6.0 ppm (PP 9F7602). The notice referenced summaries of the petitions prepared by Bayer CropScience, 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 recommended for tolerances levels different from those proposed in the petitions for dry pea seed, spearmint tops, and peppermint tops. 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 spiromesifen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with spiromesifen 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. Spiromesifen shows low acute toxicity via the oral, dermal and inhalation routes of exposure. It was neither an eye nor dermal irritant, but showed moderate potential as a contact sensitizer. In short- and long-term animal toxicity tests, the critical effects observed were loss of body weight, adrenal effects (discoloration, decrease in fine vesiculation, and the presence of cytoplasmic eosinophilia in zona fasciculata cells), thyroid effects (increased thyroid stimulating hormone, increased thyroxine binding capacity, decreased T3 and T4 levels, colloidal alteration and thyroid follicular cell hypertrophy), liver effects (increased alkaline phosphatase, ALT and decreased cholesterol, triglycerides), and spleen effects (atrophy, decreased spleen cell count, and increased macrophages). Spiromesifen shows no significant developmental or reproductive effects, is not likely to be carcinogenic based on bioassays in rats and mice, and lacks in vivo and in vitro mutagenic effects. Spiromesifen is not considered a neurotoxic chemical based on the chemical's mode of action and the available data from multiple studies, including acute and subchronic neurotoxicity studies. Specific information on the studies received and the nature of the adverse effects caused by spiromesifen 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.regulations.gov in the document titled ``Spiromesifen: Human-Health Risk Assessment for Proposed Section 3 Uses on Leaf Petioles Subgroup 4B; Pea, Dry, Seed; Spearmint, Tops; and Peppermint, Tops'' on pages 22 to 26 in docket ID number EPA-HQ-OPP-2009-0682. 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 [[Page 53583]] are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level - generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD) - and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for spiromesifen used for human risk assessment is shown in the Table of this unit. Table --Summary of Toxicological Doses and Endpoints for Spiromesifen for Use in Human Health Risk Assessment -------------------------------------------------------------------------------------------------------------------------------------------------------- Point of Departure and Uncertainty/ Exposure/Scenario Safety Factors RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects -------------------------------------------------------------------------------------------------------------------------------------------------------- Acute dietary An endpoint of concern (general population and all population attributable to a single dose was subgroups.................................. not identified. An aRfD was not established. -------------------------------------------------------------------------------------------------------------------------------------------------------- Chronic dietary NOAEL= 2.2 mg/kg/day UFA = 10x Chronic RfD = 0.022 mg/kg/day 2-generation reproduction study in (All populations)........................... UFH = 10x cPAD = 0.022 mg/kg/day rats. FQPA SF = 1x The parental systemic LOAEL: 13.2 mg/kgbw/day based on significantly decreased spleen weight (absolute and relative in parental females and F1 males) and significantly decreased growing ovarian follicles in females. -------------------------------------------------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation).................. Spiromesifen has been classified as ``not likely to be carcinogenic to humans.'' -------------------------------------------------------------------------------------------------------------------------------------------------------- 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. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to spiromesifen, EPA considered exposure under the petitioned- for tolerances as well as all existing spiromesifen tolerances in 40 CFR 180.607. EPA assessed dietary exposures from spiromesifen 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 spiromesifen; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Cummulative Survey of Food Intake by Individuals. As to residue levels in food, EPA assumed tolerance-level residues for all commodities except for the leafy-greens and leafy Brassica greens subgroups (4A and 5B). The tolerance values for leafy vegetables and spearmint and peppermint tops and oil were adjusted upward to account for the metabolite BSN 2060-4-hydroxymethyl (free and conjugated), which is a residue of concern in leafy vegetables for risk assessment purposes only. EPA used data from the lettuce metabolism studies to create a tolerance-equivalent value for the parent spiromesifen and the BSN 2060-4-hydroxymethyl metabolite to estimate residues in leafy crops. Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors and 100 percent crop treated were assumed for all commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that spiromesifen does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for spiromesifen. As discussed above, for the leafy- greens and leafy Brassica greens subgroups (4A and 5B) and spearmint and peppermint tops and oil, the residue values were adjusted upward to account for the metabolite BSN 2060-4-hydroxymethyl (free and conjugated). 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for spiromesifen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of spiromesifen. 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 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 spiromesifen for chronic exposures for non-cancer assessments are estimated to [[Page 53584]] be 188 ppb for surface water and 86 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 188 ppb was used to assess the contribution to drinking water. 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). Spiromesifen 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 spiromesifen to share a common mechanism of toxicity with any other substances, and spiromesifen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that spiromesifen 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 website 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 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. There is no evidence of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to spiromesifen. In the prenatal developmental toxicity studies in rats and rabbits and in the 2-generation reproduction study in rats, developmental toxicity to the offspring occurred at equivalent or higher doses than parental toxicity. 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 spiromesifen is complete and no additional immunotoxicity or neurotoxicty testing is required. The rationale is described below: a. Because spleen effects were seen in several toxicity studies, the registrant pursued specialized immunotoxicity studies in rats and mice that were both negative. These studies satisfy the revised 40 CFR part 158 requirement for immunotoxicity testing. In addition, the endpoints selected for the risk assessment are considered protective of any possible immunotoxic effects. b. There is no concern for neurotoxicity resulting from exposure to spiromesifen. Neurotoxic effects such as reduced motility, spastic gait, increased reactivity, tremors, clonic-tonic convulsions, reduced activity, labored breathing, vocalization, avoidance reaction, piloerection, limp, cyanosis, squatted posture, and salivation were observed in two studies (5-day inhalation and subchronic oral rat) at high doses (134 and 536 milligrams/kilogram/day (mg/kg/day), respectively). These effects were neither reflected in neurohistopathology nor in other studies. Because these effects were not observed in the acute and subchronic neurotoxicity studies, they were not considered reproducible. Thus, based on the chemical's mode of action and the available data from multiple studies, the chemical is not considered neurotoxic. ii. There is no evidence that spiromesifen 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. A developmental neurotoxicity study is not required. iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to spiromesifen in drinking water. These assessments will not underestimate the exposure and risks posed by spiromesifen. 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 acute PAD (aPAD) and chronic PAD (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, spiromesifen 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 spiromesifen from food and water will utilize 78% of the cPAD for all infants <1 year old, the population group receiving the greatest exposure. There are no residential uses for spiromesifen. 3. Short- and intermediate-term risk. Short-term and intermediate- term aggregate exposure takes into account short-term and intermediate- term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term and intermediate-term adverse effect was identified; however, spiromesifen is not registered for any use patterns that would result in short-term or intermediate-term residential exposure. Short- term and intermediate-term risk is assessed based on short-term and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short-term or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term and intermediate-term risk), no further assessment of short-term or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term and intermediate-term risk for spiromesifen. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two [[Page 53585]] adequate rodent carcinogenicity studies, spiromesifen is not expected to pose a cancer risk to humans. 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, or to infants and children from aggregate exposure to spiromesifen residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (high-performance liquid chromatography/mass spectroscopy (HPLC/MS/MS)/Method 00631/M001 and Method 110333) 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; e-mail address: [email protected]. 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. No Codex or Canadian MRLs have been established for spiromesifen in/on leaf petioles subgroup 4B; pea, dry, seed; spearmint, tops; and peppermint, tops. C. Revisions to Petitioned-For Tolerances Pea, dry, seed: The Agency is modifying the tolerance from the proposed level of 0.15 to 0.20. The adjusted field trial data for dry peas were evaluated using the Agency's maximum-likelihood estimation (MLE) spreadsheet and then the Agency's maximum-residue limit (MRL) tolerance spreadsheet as described in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine the appropriate tolerance level. The tolerance spreadsheet recommended a tolerance of 0.20 ppm for total residues of spiromesifen in/on dry peas. Spearmint, tops and peppermint, tops: The Agency is modifying the tolerances from the proposed level of 25 ppm to 45 ppm. The adjusted field trial data for mint were evaluated using the Agency's MRL tolerance spreadsheet as described in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine the appropriate tolerance level. The tolerance spreadsheet recommended a tolerance of 45 ppm for total residues of spiromesifen for both spearmint and peppermint tops. Finally, EPA has revised the tolerance expression to clarify: 1. That, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of spiromesifen not specifically mentioned; and 2. That compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression. V. Conclusion Therefore, tolerances are established for residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, determined by measuring only the sum of spiromesifen [2- oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3- dimethylbutanoate], its enol metabolite (4-hydroxy-3-(2,4,6- trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), calculated as the stoichiometric equivalent of spiromesifen, in or on pea, dry, seed at 0.20 ppm; spearmint, tops at 45 ppm; peppermint, tops at 45 ppm; and leaf petiole subgroup 4B at 6.0 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) (Public Law 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 [[Page 53586]] 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 20, 2010. Lois Rossi, Director, Registration Division, Office of Pesticide Program. 0 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. Section 180.607 is amended by alphabetically adding the following commodities to the table in paragraph (a)(1) and revising paragraphs (a)(1) introductory text, (a)(2) introductory text, (b) introductory text, and (d) introductory text to read as follows: Sec. 180.607 Spiromesifen; tolerances for residues. (a) General. (1) Tolerances are established for residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1- oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3- (2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as the stoichiometric equivalent of spiromesifen, in or on the following primary crop commodities: ------------------------------------------------------------------------ Commodity Parts per million ------------------------------------------------------------------------ * * * * * Leaf petiole subgroup 4B....................... 6.0 * * * * * Pea, dry, seed................................. 0.20 Peppermint, tops............................... 45 Spearmint, tops................................ 45 * * * * * ------------------------------------------------------------------------ (2) Tolerances are established for residues of the insecticide/ miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en- 4-yl 3,3-dimethylbutanoate] and its metabolites containing the 4- hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one and 4- hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3- en-2-one moieties, calculated as the stoichiometric equivalent of spiromesifen, in the following livestock commodities: * * * * * (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1- oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3- (2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as the stoichiometric equivalent of spiromesifen, in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the table. * * * * * (d) Indirect or inadvertent residues. Tolerances are established for the inadvertent or indirect residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en- 4-yl 3,3-dimethylbutanoate], 4-hydroxy-3-(2,4,6-trimethylphenyl)-1- oxaspiro[4.4]non-3-en-2-one, and its metabolites containing the 4- hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3- en-2-one moiety, calculated as the stoichiometric equivalent of spiromesifen, in the following rotational crop commodities: * * * * * [FR Doc. 2010-21686 Filed 8-31-10; 8:45 am] BILLING CODE 6560-50-S