Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Zeta-cypermethrin,

[Federal Register: December 29, 2006 (Volume 71, Number 250)]

[Rules and Regulations]

[Page 78374-78382]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr29de06-11]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0769; FRL-8093-6]

Zeta-Cypermethrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for residues of the insecticide zeta-cypermethrin, in or on almond, hulls; animal feed, nongrass, group 18, forage; animal feed, nongrass, group 18, hay; berry, group 13; cilantro, leaves; food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments; fruit, pome, group 11; fruit, stone, group 12; grape; grass, forage, group 17; grass, hay, group 17; nut, tree, group 14; peanut; rapeseed; sunflower; sunflower, refined oil; turnip, greens; vegetable, cucurbit, group 9; and vegetable, root and tuber, group 1, except sugar beet. FMC Corporation and Interregional Research Project Number 4 (IR-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 December 29, 2006. Objections and requests for hearings must be received on or before February 27, 2007, 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-2006-0769. 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 Room S-4400, One Potomac Yard (South Building), 2777 South Crystal Drive, Arlington, VA 22202-3553. 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: Linda DeLuise, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone number: (703) 305-5428; e-mail address: deluise.linda@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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 andfarmers, dairy cattle farmers, livestock farmers.

      Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; 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.

   2. 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

      [[Page 78375]]

      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 .

   3. 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-2006-0769 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 February 27, 2007.

      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-2006-0769, 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 Avenue, NW., Washington, DC 20460-0001.

      Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Room S-4400, One Potomac Yard (South Building), 2777 South Crystal Drive, Arlington, VA 22202-3553. 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.

2. Background and Statutory Findings

   In the Federal Register of November 8, 2000 (65 FR 67003) (FRL- 6750-2); August 2, 2002 (67 FR 50430) (FRL-7185-9); July 16, 2003 (68 FR 42030) (FRL-7314-7); March 16, 2005 (70 FR 12874) (FRL-7705-2); May 10, 2006 (71 FR 27243) (FRL-8067-8); and August 25, 2006 (71 FR 50414) (FRL-8088-9), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 1F3994; PP 2F6444; PP 3E6677; PP 3F6577; PP 4F6893; and PP 5F6896) by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103-7597 and Interregional Research Project Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. These petitions requested that 40 CFR 180.418 be amended by establishing a tolerance for residues of the insecticide zeta-cypermethrin, (S)- cyano(3-phenoxyphenyl)methyl ()-cis-trans-3-(2,2- dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate), in or on barley, grain at 0.5 parts per million (ppm) (5F6896); barley, hay at 2 ppm (5F6896); barley, straw at 4 ppm (5F6896); berries group at 0.5 ppm (5F6896); canola, meal at 0.05 ppm (5F6896); canola, oil at 0.6 ppm (5F6896); canola, seed at 0.05 ppm (5F6896); cilantro at 10 ppm (3E6677); cucurbit vegetables at 0.1 ppm (2F6444); food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments at 0.05 ppm (4F6893); fruit, pome, group 11 at 0.6 ppm (3F6577); fruit, stone, group 12 at 0.9 ppm (3F6577); grapes at 1 ppm (5F6896); grass, forage at 7 ppm (5F6896); grass, hay at 22 ppm (5F6896); grass, straw at 8 ppm (5F6896); grass, screenings at 12 ppm (5F6896); juice, grape at 0.05 ppm (5F6896); nongrass animal feed, forage at 10 ppm (5F6896); nongrass animal feed, hay at 33 ppm (5F6896); peanuts at 0.05 ppm (2F6444); raisins at 0.2 ppm (5F6896); root and tuber vegetables, roots at 0.1 ppm (2F6444); sunflower at 0.2 ppm (1F3994); sunflower oil at 0.2 ppm (1F3994); tree nut group, nutmeat at 0.05 ppm (5F6896); tree nut group, hulls at 3 ppm (5F6896); and turnip greens at 14 ppm (3E6677). These notices included a summary of the petition prepared by FMC Corporation, the registrant, and IR-4. There were no comments received in response to these notices of filing.

   The proposed tolerances were later amended as follows: almond, hulls at 6 ppm (5F6896); animal feed, nongrass, group 18, forage at 8 ppm (5F6896); animal feed, nongrass, group 18, hay at 40 ppm (5F6896); berry, group 13 at 0.8 ppm (5F6896); cilantro, leaves at 10 ppm (3E6677); food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments at 0.05 ppm (4F6893); fruit, pome, group 11 at 2 ppm (3F6577); fruit, stone, group 12 at 1 ppm (3F6577); grape at 2 ppm (5F6896); grass, forage, group 17 at 10 ppm (5F6896); grass, hay, group 17 at 35 ppm (5F6896); nut, tree, group 14 at 0.05 ppm (5F6896); peanut at 0.05 ppm (2F6444); rapeseed at 0.2 ppm (5F6896); sunflower at 0.2 ppm (1F3994); sunflower, refined oil at 0.5 ppm (1F3994); turnip, greens at 14 ppm (3E6677); vegetable, cucurbit, group 9 at 0.2 ppm (2F6444); and vegetable, root and tuber, group 1, except sugar beet at 0.1 ppm (2F6444).

   For various reasons, EPA has decided not to establish several of the proposed tolerances. The proposed tolerances for canola meal, canola oil, grape juice and raisins oil are not being established because grape and canola processing studies indicate that residues in these processed commodities do not concentrate above the tolerance level in raw commodity. The proposed tolerances in barley grain, hay and straw are not being established because there was an inadequate number of residue field trials submitted in support of these tolerances. The proposed tolerances for grass screenings and grass straw are not being established because these commodities are not significant livestock feed items.

   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

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   http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

3. 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 residues of zeta-cypermethrin, in or on almond, hulls at 6 ppm; animal feed, nongrass, group 18, forage at 8 ppm; animal feed, nongrass, group 18, hay at 40 ppm; berry, group 13 at 0.8 ppm; cilantro, leaves at 10 ppm; food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments at 0.05 ppm; fruit, pome, group 11 at 2 ppm; fruit, stone, group 12 at 1 ppm; grape at 2 ppm; grass, forage, group 17 at 10 ppm; grass, hay, group 17 at 35 ppm; nut, tree, group 14 at 0.05 ppm; peanut at 0.05 ppm; rapeseed at 0.2 ppm; sunflower at 0.2 ppm; sunflower, refined oil at 0.5 ppm; turnip, greens at 14 ppm; vegetable, cucurbit, group 9 at 0.2 ppm; and vegetable, root and tuber, group 1, except sugar beet at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

   1. 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. The toxicology database for zeta-cypermethrin/cypermethrin is complete, and there are no data gaps. The specific quality is relatively high and the toxicity profile of zeta-cypermethrin can be characterized for all effects, including potential developmental, reproductive, neurotoxic, carcinogenic and mutagenic effects.

      More detailed information on the studies received and the nature of the toxic effects caused by zeta-cypermethrin 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 in the document entitled, zeta-cypermethrin: Revised Human Health Risk Assessment for Proposed Uses on Numerous Raw Agricultural Commodities. Petitions: 3F6577, 3E6677, 2F6444, 4F6893 and 5F6896 for the Establishment of Tolerances on Various Raw Agricultural, Processed Commodities and Food Items in Food Handling Establishments. PC Code: 109702, D334263. Regulatory Action: Section 3. Risk Assessment Type: Zeta-Cypermethrin/Cypermethrin Aggregate,'' dated November 29, 2006, by going to http://www.regulations.gov, and searching for docket ID number

      EPA-HQ-OPP-2006-0769. Locate and click on the hyperlink for EPA document ID number EPA-HQ-OPP-2006-0769-0031. Double-click on the document to view the referenced information on pages 16-20.

   2. 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 and 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 zeta-cypermethrin used for human risk assessment is shown below in Table 1 of this unit:

      Table 1.--Summary of Toxicological Dose and Endpoints for Use in Human Risk Assessment

      FQPA SF and Level of Exposure/Scenario

      Dose Used in Risk

      Concern for Risk Study and Toxicological Assessment, UF*

      Assessment

      Effects

      Acute Dietary (U.S. general

      NOAEL = 10 mg/kg/day FQPA SF = 1x

      Acute neurotoxicity population including infants and UF = 100x.............. aPAD = acute RfD / FQPA study - rat (zeta- children)

      Acute RfD = 0.1 mg/kg/ SF = 0.1 mg/kg/day. cypermethrin); day.

      LOAEL = 50 mg/kg/day based on clinical signs of neurotoxicity and changes in the FOB.

      Chronic Dietary (All populations) NOAEL = 6 mg/kg/day FQPA SF = 1x

      Chronic feeding study - UF = 100x.............. cPAD = chronic RfD / dog; Chronic RfD = 0.06 mg/ FQPA SF = 0.06 mg/kg/ LOAEL = 20.4/18.1 mg/kg/ kg/day.

      day.

      day based on clinical signs of neurotoxicity and mortality in males, and decreased body weight and body weight gain in females.

      Short- and Intermediate-Term

      NOAEL = 7.4 mg/kg/day Residential LOC for MOE Developmental Incidental Oral (1 day to 6 months)

      = 100

      neurotoxicity study - Occupational LOC for rat (zeta- MOE = N/A.

      cypermethrin); LOAEL = 17 mg/kg/day based on decreased body weight in the offspring.

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      Short- and Intermediate-Term Dermal NOAEL = 7.4 mg/kg/day Residential LOC for MOE Developmental (Infants and Children Only; 1 day to (dermal absorption = 100

      neurotoxicity study - 6 months)

      rate = 2.5%)

      rat (zeta- cypermethrin); LOAEL = 17 mg/kg/day based on decreased body weight in the offspring.

      Short- and Intermediate-Term Dermal None.

      Occupational LOC for No systemic effects (Adults, Workers; 1 day to 6 months)

      MOE = N/A

      were observed in a 21- day dermal study (zeta- cypermethrin) up to 1,000 mg/kg/day and there is no developmental concern. No hazard identified to support quantification of risk.

      Long-Term Dermal (>6 months)

      NOAEL = 6 mg/kg/day Residential LOC for MOE Chronic feeding study - (dermal absorption = 100

      dog; rate = 2.5%)

      Occupational LOC for LOAEL = 20.4/18.1 mg/kg/ MOE = 100.

      day based on clinical signs of neurotoxicity and mortality in males, and decreased body weight and body weight gain in females.

      Short- and Intermediate-Term

      NOAEL = 2.7 mg/kg/day Residential LOC for MOE 21-day inhalation study Inhalation (1 to 6 months)

      (inhalation absorption = 100

      - rat; rate = 100% oral

      Occupational LOC for LOAEL = 0.05 mg/kg/day equivalent)

      MOE = 100.

      based on decreases in body weight and salivation.

      Long-Term Inhalation (>6 months) NOAEL = 2.7 mg/kg/day Residential LOC for MOE 21-day inhalation study (inhalation absorption = 300

      - rat; rate = 100% oral

      Occupational LOC for LOAEL = 0.05 mg/kg/day equivalent)

      MOE = 300 (For the based on decreases in lack of an alternative body weight and study. Route-to-route salivation. estimation would result in a less protective endpoint.).

      Cancer (oral, dermal, inhalation)

      Zeta-Cypermethrin has been classified as a Category C (possible human carcinogen); therefore, no quantification is required. The chronic RfD/ PAD will adequately account for all chronic toxicity effects, including carcinogenicity, likely to result from exposure to this pesticide.

      \*\UF = uncertainty factor; FQPA SF = any additional safety factor retained to account for data deficiencies or residual concerns unique to the FQPA; NOAEL = no observed adverse effect level; LOAEL = lowest observed adverse effect level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference dose; MOE = margin of exposure; LOC = level of concern; and N/A = not applicable.

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.418) for the residues of zeta-cypermethrin, (S)-cyano(3-phenoxyphenyl)methyl ()-cis-trans-3-(2,2- dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate), in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from zeta-cypermethrin in food. Modeled drinking water estimates were included in both the acute and chronic dietary exposure analyses 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.

      The Agency conducted an unrefined acute dietary exposure assessment using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\TM\, Version 2.03). This analysis evaluated the individual food consumption 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 acute analysis is based on Tier 1 assumptions of tolerance-level residues for existing uses and Agency-recommended tolerance levels for the numerous proposed new uses and 100% crop treated (CT) for all commodities.

      ii. Chronic exposure. In conducting the chronic dietary exposure assessment, the DEEM-FCID\TM\ analysis evaluated the individual food consumption data as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity.Anticipated residues (averages for crop field trials) were calculated for the numerous proposed new uses from field trial data. 100% CT was assumed for all proposed new uses except for non-grass animal feed; and grass fodder, forage and hay. For existing uses, anticipated residues are based on USDA PDP monitoring data, crop field trial data and empirical processing factors and may be considered refined.

      iii. Cancer. Zeta-cypermethrin was classified as a group ``C'' (possible human carcinogen), based on an increased incidence of lung adenonas and adenomas plus carcinomas combined in female mice. The evidence was not considered strong enough to warrant a quantitative estimation of human cancer risk. Risk assessments based on endpoint selected for the chronic population adjusted dose (cPAD) will be protective of any potential carcinogenic risk from exposure to zeta- cypermethrin for the U.S. general population and all population subgroups, including infants and children. Additionally, EPA relied

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      on the chronic exposure assessment in assessing cancer risk.

      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 the 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 the FFDCA, EPA may require registrants to submit data on PCT.

      The Agency used PCT information as follows:

      For cypermethrin: broccoli, 6%; bulb crops, 16%; cabbage, 3%; cauliflower, 13%; celery, 1%; cole crops, 3%; collards, 9%; cotton, 5%; garlic, 13%; greens, mustard, 8%; greens, turnips, 4%; kale, 13%; lettuce, 26%; onions, 15%; pecans, 5%; and spinach, 2%.

      For zeta-cypermethrin: bulb crops, 4%; cabbage, 1%; carrots, 1%; cole crops, 1%; corn, field, )-cis- trans-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate), in or on almond, hulls at 6 ppm; animal feed, nongrass, group 18, forage at 8 ppm; animal feed, nongrass, group 18, hay at 40 ppm; berry, group 13 at 0.8 ppm; cilantro, leaves at 10 ppm; food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments at 0.05 ppm; fruit, pome, group 11 at 2 ppm; fruit, stone, group 12 at 1 ppm; grape at 2 ppm; grass, forage, group 17 at 10 ppm; grass, hay, group 17 at 35 ppm; nut, tree, group 14 at 0.05 ppm; peanut at 0.05 ppm; rapeseed at 0.2 ppm; sunflower at 0.2 ppm; sunflower, refined oil at 0.5 ppm; turnip, greens at 14 ppm; vegetable, cucurbit, group 9 at 0.2 ppm; and vegetable, root and tuber, group 1, except sugar beet at 0.1 ppm.

6. 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 (65 FR 67249, 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

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   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.

7. 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: December 21, 2006. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs.

   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 180.418 is amended by alphabetically adding commodities to the table in paragraph (a)(2) to read as follows:

   Sec. 180.418 Cypermethrin and an isomer zeta-cypermethrin; tolerances for residues.

   (a)* * *

   (2) * * *

   Parts Commodity

   per million

   * * * * * Almond, hulls..................................................

   6 Animal feed, nongrass, group 18, forage........................

   8 Animal feed, nongrass, group 18, hay........................... 40 * * * * * Berry, group 13................................................ 0.8 * * * * * Cilantro, leaves............................................... 10 * * * * * Food/feed items (other than those covered by a higher tolerance 0.05 as a result of use on growing crops) in food/feed handling establishments................................................ Fruit, pome, group 11..........................................

   2 Fruit, stone, group 12.........................................

   1 * * * * * Grape..........................................................

   2 Grass, forage, group 17........................................ 10 Grass, hay, group 17........................................... 35 * * * * * Nut, tree, group 14............................................ 0.05 * * * * * Peanut......................................................... 0.05 * * * * * Rapeseed....................................................... 0.2 * * * * * Sunflower...................................................... 0.2 Sunflower, refined oil......................................... 0.5 * * * * * Turnip, greens................................................. 14 * * * * * Vegetable, cucurbit, group 9................................... 0.2 * * * * * Vegetable, root and tuber, group 1, except sugar beet.......... 0.1 * * * * *

   * * * * *

   [FR Doc. E6-22288 Filed 12-28-06; 8:45 am]

   BILLING CODE 6560-50-S