Zeta-cypermethrin; Pesticide Tolerance, 1517-1525 [E7-25392]

Download as PDF Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations adopted EDSTAC’s recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA has authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/ or testing protocols being considered under the Agency’s EDSP have been developed, PHMB may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. B. Analytical Method(s) An analytical method for food is not needed. Food contact sanitizers are typically regulated by state health departments to ensure that the food industry is using these products in compliance with regulations in 40 CFR 180.940. The end use solution that is applied to the food contact surface is analyzed not food items that may come into contact with the treated surface. An analytical method is available to analyze the use dilution that is applied to food contact surfaces. The solution can be analyzed by use of the spectrophotometric method. C. Existing Tolerances There is no existing tolerance or exemption from tolerance for PHMB. pwalker on PROD1PC71 with NOTICES D. International Tolerances No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been established for any food uses at this time. VIII. 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 final rule has been exempted from review under Executive Order 12866, 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) or Executive Order 13045, entitled Protection of Children from VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 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 6, 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). IX. 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 1517 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 18, 2007. Betty Shackleford, Acting Director, Antimicrobials Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.1280 is added to subpart D to read as follows: I § 180.1280 Poly(hexamethylenebiguanide) hydrochloride (PHMB) exemption from the requirement of a tolerance. Poly(hexamethylenebiguanide) hydrochloride (PHMB)(CAS Reg. No. 32289–58–0) is exempt from the requirement of a tolerance for residues of the antimicrobial in or on all food commodities when the residues are the result of the lawful application of a food contact surface sanitizer containing PHMB at 550 parts per million (ppm). [FR Doc. E8–189 Filed 1–8–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0300; FRL–8346–3] Zeta-cypermethrin; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for combined residues of zeta-cypermethrin and its inactive Risomers in or on Citrus (dried pulp, fruit and oil); oilseed commodities (seeds of borage, castor oil plant, Chinese tallow tree, crambe, cuphea, echium, euphorbia, evening primrose, flax, gold of pleasure, hare’s-ear mustard, jojoba, E:\FR\FM\09JAR1.SGM 09JAR1 pwalker on PROD1PC71 with NOTICES 1518 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations lesquerella, lunaria, meadowfoam, milkweed, mustard, niger seed, oil radish, poppy, rose hip, sesame, Stokes aster, sweet rocket, tallowwood, tea oil plant, and vernonia); oilseed, refined oils (refined oils of castor oil plant, Chinese tallowtree, euphorbia, evening primrose, jojoba, niger seed, rose hip, stokes aster, tallowwood, tea oil plant and vernonia); okra; rice, wild; and safflower, seed. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also deletes time-limited flax seed tolerances which are made redundant and unnecessary by establishment of the permanent tolerance on flax seed. DATES: This regulation is effective January 9, 2008. Objections and requests for hearings must be received on or before March 10, 2008, 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–2007–0300. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in 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: Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 (703) 305-5218; e-mail address: stanton.susan@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 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 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 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 EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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–2007–0300 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 as required by 40 CFR part 178 on or before March 10, 2008. 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 this copy, identified by docket ID number EPA– HQ–OPP–2007–0300, 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’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. Petition for Tolerance In the Federal Register of June 27, 2007 (72 FR 35237-35242) (FRL–8133– 4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 6E7132 and PP 6E7133) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540-6635. The petitions requested that 40 CFR 180.418 be amended by establishing tolerances for combined residues of the insecticide zetacypermethrin, S-cyano(3phenoxyphenyl) methyl (±)-cis-trans 3(2,2-dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate and its inactive R-isomers, in or on the following food commodities: PP 6E7132 - Rice, wild, grain at 1.50 parts per million (ppm); okra at 0.20 ppm; E:\FR\FM\09JAR1.SGM 09JAR1 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations pwalker on PROD1PC71 with NOTICES safflower, seed at 0.20 ppm; and PP 6E7133 - Fruit, citrus, group 10 at 0.25 ppm; citrus, dried, pulp at 0.50 ppm; and citrus, oil at 0.90 ppm. That notice referenced a summary of the petition prepared by FMC Corporation, the registrant, which is available to the public in the docket, http:// www.regulations.gov. There were no comments received in response to the notice of filing. In the Federal Register of October 24, 2007 (72 FR 60369-60371) (FRL–8150– 8), 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 7E7255) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540-6635. The petition requested that 40 CFR 180.418 be amended by establishing tolerances for combined residues of the insecticide zeta-cypermethrin, S-cyano(3phenoxyphenyl) methyl (±)-cis-trans 3(2,2-dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate and its inactive R-isomers, at 0.2 ppm in or on the following commodities: borage, seed; castor oil plant, seed; Chinese tallowtree, seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose, seed; flax, seed; gold of pleasure, seed; hare’s ear mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed; poppy, seed; rose hip, seed; sesame, seed; Stokes aster, seed; sweet rocket, seed; tallowwood, seed; tea oil plant, seed; and vernonia, seed. That notice referenced a summary of the petition prepared by FMC Corporation, the registrant, which is available to the public in the docket, http:// www.regulations.gov. Comments were received from a private citizen on the notice of filing. EPA’s response to these comments is discussed in Unit IV.C. below. Based upon review of the data supporting the petition, EPA has revised the tolerance levels for citrus commodities and determined that a separate tolerance is needed for refined oils derived from several of the proposed oilseed crops. The reason for these changes is explained in Unit V. 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 VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 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....’’ These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 the petitioned-for tolerance for combined residues of zetacypermethrin and its inactive R-isomers on Borage, seed at 0.2 ppm; Castor oil plant, refined oil at 0.4 ppm; Castor oil plant, seed at 0.2 ppm; Chinese tallowtree, refined oil at 0.4 ppm; Chinese tallowtree, seed at 0.2 ppm; Citrus, dried pulp at 1.8 ppm; Citrus, oil at 4.0 ppm; Crambe, seed at 0.2 ppm; Cuphea, seed at 0.2 ppm; Echium, seed at 0.2 ppm; Euphorbia, refined oil at 0.4 ppm; Euphorbia, seed at 0.2 ppm; Evening primrose, refined oil at 0.4 ppm; Evening primrose, seed at 0.2 ppm; Flax, seed at 0.2 ppm; Fruit, citrus, group 10 at 0.35 ppm; Gold of pleasure, seed at 0.2 ppm; Hare’s-ear mustard, seed at 0.2 ppm; Jojoba, refined oil at 0.4 ppm; Jojoba, seed at 0.2 ppm; Lesquerella, seed at 0.2 ppm; Lunaria, seed at 0.2 pm; Meadowfoam, seed at 0.2 ppm; Milkweed, seed at 0.2 ppm; Mustard, seed at 0.2 ppm; Niger seed, refined oil at 0.4 ppm; Niger seed, seed at 0.2 ppm; Oil radish, seed at 0.2 ppm; Okra at 0.2 ppm; Poppy, seed at 0.2 ppm; Rice, wild, grain at 1.5 ppm; Rose hip, refined oil at 0.4 ppm; Rose hip, seed at 0.2 ppm; Safflower, seed at 0.2 ppm; Sesame, seed at 0.2 ppm; Stokes aster, refined oil at 0.4 ppm; Stokes aster, seed at 0.2 ppm; Sweet rocket, seed at 0.2 ppm; Tallowwood, refined oil at 0.4 ppm; Tallowwood, seed at 0.2 ppm; Tea oil plant, refined oil at 0.4 ppm; Tea oil plant, seed at 0.2 ppm; Vernonia, refined oil at 0.4 ppm; and Vernonia, seed at 0.2 ppm. EPA’s assessment of exposures and risks PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 1519 associated with establishing the tolerance follows. Zeta-cypermethrin is an enriched version of the synthetic pyrethroid insecticide cypermethrin. Cypermethrin [(±) a-cyano-(3-phenoxyphenyl)methyl (±)-cis, trans-3-(2,2-dichloroethenyl)-2,2dimethylcyclopropanecarboxylate] is a racemic mixture of eight isomers (each with percentages of 11-14%). Zetacypermethrin consists primarily of the four isomers with the ‘‘S’’ configuration at the cyano-bearing carbon. While cypermethrin and zeta-cypermethrin are separate active ingredients, each registered in separate end-use products, they are considered together in this risk assessment due to the close similarity of their uses, toxicity, and chemical characteristics. 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 adverse effects caused by cypermethrin/zeta-cypermethrin as well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in the document Zeta-cypermethrin: Human Health Risk Assessment for Section 3 Use of Zetacypermethrin on Citrus (Crop Group 10), Oilseeds (proposed Crop Group 20, except cottonseed), Safflower, Wild Rice and Okra. The referenced document is available in the docket established by this action, which is described under ADDRESSES and is identified as document ID number EPA–HQ–OPP– 2007–0300-0006 in that docket. The toxicity data for zetacypermethrin indicate one major target for this chemical: the neuromuscular system. There may be some liver effects as well; however, these may be an adaptive response. The neuromuscular effects (tremors, gait abnormalities, and decreases in motor activity) occur mainly in oral studies in the dog and the rat. Similar effects were observed in a rat inhalation study conducted with cypermethrin. As with other pyrethroids, the neuromuscular effects appear to be transient acute effects and do not appear to increase in severity with increasing duration of exposure. Studies on zeta-cypermethrin, in addition to those on cypermethrin, E:\FR\FM\09JAR1.SGM 09JAR1 1520 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations pwalker on PROD1PC71 with NOTICES show that it is not a developmental or reproductive toxicant. In the prenatal developmental toxicity studies in rats and rabbits, there was no evidence of developmental toxicity up to the highest dose tested. Maternal toxicity was observed in these studies in the form of decreased body weight gain and food consumption and/or clinical signs of neurotoxicity such as gait abnormalities. In the multi-generation reproduction studies in rats, offspring toxicity was observed at the same treatment level that resulted in parental systemic toxicity. There did not appear to be any increases in severity of toxicity for the pups in these studies. In the developmental neurotoxicity (DNT) study, there was limited evidence of increased susceptibility of the offspring. No toxicity was observed in the maternal animals at the highest dose tested, while decreased body weight, decreased subsession motor activity, and changes in brain morphometry were seen in the offspring at this same dose. With the available toxicity database at this time, there is no evidence of endocrine disruption. EPA has classified cypermethrin/zetacypermethrin as a possible human carcinogen, based on an increased incidence of lung adenomas and combined adenomas plus carcinomas in female mice. The presence of common benign tumors (lung adenomas) in one species (mice) and one sex (female), with no increase in the proportion of malignant tumors or decrease in the time-to-tumor occurrence, together with the lack of mutagenic activity, was not considered strong enough evidence to warrant a quantitative estimation of human cancer risk. The point-ofdeparture selected for deriving the chronic reference dose will account for all chronic effects as well as potential cancer effects. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/ safety factors (UFs) are used in conjunction with the LOC to take into account 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 VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty factors (UFs) is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. 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 zeta-cypermethrin/ cypermethrin used for human risk assessment can be found at http:// www.regulations.gov at pages 25-26 in the document Zeta-cypermethrin: Human Health Risk Assessment for Section 3 Use of Zeta-cypermethrin on Citrus (Crop Group 10), Oilseeds (proposed Crop Group 20, except cottonseed), Safflower, Wild Rice and Okra in docket ID number EPA–HQ– OPP–2007–0300. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cypermethrin/zetacypermethrin, EPA considered exposure under the petitioned-for tolerances as well as all existing cypermethrin/zetacypermethrin tolerances in 40 CFR 180.418. Cypermethrin and zetacypermethrin are registered for use on some of the same commodities; however, when both are applied to the same crop in the same year, the maximum seasonal rate may not exceed the maximum seasonal rate for cypermethrin when used alone. Therefore, EPA has not assumed that residues of both cypermethrin and zetacypermethrin would appear on the same crop. EPA assessed dietary exposures from cypermethrin/zeta-cypermethrin 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 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 occurring as a result of a 1–day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. For crops with both cypermethrin and zeta-cypermethrin tolerances, the higher of the two tolerances was assumed. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994–1996 and 1998 CSFII. As to residue levels in food, EPA calculated anticipated residues for most commodities. Anticipated residues were based on USDA Pesticide Data Program (PDP) monitoring data or crop field trial data and in many cases were further adjusted to reflect actual percent crop treated (PCT) estimates. For crops with both cypermethrin and zetacypermethrin registrations, the higher of the two PCT estimates was assumed. EPA assumed 100 PCT for all of the new uses. Anticipated residues were calculated for livestock commodities using the residue data from livestock feeding studies in conjunction with anticipated dietary burdens from consumption of cypermethrin/zetacypermethrin treated feed items. Projected PCT (PPCT) estimates were used in these calculations for certain recently registered feed items (alfalfa hay, other hay and pasture/rangeland grasses), since reliable PCT estimates based on historical usage are not yet available. iii. Cancer. As discussed above in Unit III.A., EPA has classified cypermethrin/zeta-cypermethrin as a possible human carcinogen (Group C), based on an increased incidence of lung adenomas and combined adenomas plus carcinomas in female mice. EPA determined that the Chronic Reference Dose (cRfD) would be protective of any cancer risk posed by zeta-cypermethrin because the cRfD of 0.06 milligrams/ kilogram/day (mg/kg/day) (based on a NOAEL of 6 mg/kg/day) used for risk assessment is significantly lower than the dose of 1,600 ppm (approximately 229 mg/kg/day) at which tumors were observed; the NOAEL for tumor induction is 400 ppm (approximately 57 mg/kg/day). EPA also took into account that the benign tumors (lung adenomas) were observed in one species (mice) and one sex (female), with no increase in the proportion of malignant tumors or decrease in the time-to-tumor E:\FR\FM\09JAR1.SGM 09JAR1 pwalker on PROD1PC71 with NOTICES Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations occurrence. Together with the lack of mutagenic activity, there was not strong enough evidence to warrant a quantitative estimation of human cancer risk. Therefore, the cRfD is considered protective of both non-cancer and cancer effects and a separate cancer exposure assessment was not conducted. iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of 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 residues that have been measured in food. If EPA relies on such information, EPA must pursuant to FFDCA 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. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data 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: • Condition a. 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 b. The exposure estimate does not underestimate exposure for any significant subpopulation group. • Condition c. 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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The Agency used PCT information in the chronic dietary exposure assessment as follows: PCT estimates for existing uses: broccoli 6%, cabbage 3%, carrots 1%, cauliflower 13%, collards 9%, celery 1%, corn (field and sweet) <1%, cotton 5%, garlic 13%, kale 13%, lettuce (head and leaf) 26%, mustard greens 8%, onions 15%, peanuts <1%, pecans 9%, sorghum <1%, soybeans <1%, spinach 2%, tomato 1%, turnip greens 4% and wheat <1%. EPA uses an average PCT for chronic dietary risk analysis. The average PCT VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 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 5% except for those situations in which the average PCT is less than one. In those cases <1% is used as the average. In most cases, EPA uses available data from U. S. 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. EPA used Projected PCT (PPCT) estimates for animal feed items: alfalfa hay 3%, other hay 1% and pasture/ rangeland <1%. EPA estimates PPCT for a new pesticide use by assuming that the PCT during the pesticide’s initial 5 years of use on a specific use site will not exceed the average PCT of the market leader (i.e., the one with the greatest PCT) on that site over the three most recent surveys. Comparisons are only made among pesticides of the same pesticide types (i.e., the dominant insecticide on the use site is selected for comparison with the new insecticide). The PCTs included in the average may be each for the same pesticide or for different pesticides since the same or different pesticides may dominate for each year selected. Typically, EPA uses USDA/ NASS as the source for the PCT data because they are publicly available. When a specific use site is not surveyed by USDA/NASS, EPA uses proprietary data and calculates the estimated PCT. This estimated PPCT, based on the average PCT of the market leader, is appropriate for use in the chronic dietary risk assessment. This method of estimating a PPCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial 5 years of actual use. Predominant factors that bear on whether the estimated PPCT for these three crops could be exceeded include pest resistance concerns, relative efficacies, pest prevalence and other factors. All such relevant information that is currently available to EPA has been considered for zeta-cypermethrin on alfalfa hay, other hay and pasture/ rangeland. It is unlikely that the actual PCT for zeta-cypermethrin will exceed the estimated PPCT for this chemical on each of these three sites during the next 5 years. The Agency believes that the three conditions listed in this Unit have been met. With respect to Condition a, PCT estimates are derived from Federal and PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 1521 private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA’s computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA’s risk assessment process ensures that EPA’s exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which cypermethrin/zeta-cypermethrin may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for cypermethrin/zeta-cypermethrin 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 environmental fate characteristics of cypermethrin/zeta-cypermethrin. Further information regarding EPA’s 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 (SCIGROW) models, the estimated environmental concentrations (EECs) of cypermethrin/zeta-cypermethrin for acute exposures are estimated to be 1.04 parts per billion (ppb) for surface water and 0.0036 ppb for ground water. The EECs for chronic exposures are estimated to be 0.013 ppb for surface water and 0.0036 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 1.04 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of E:\FR\FM\09JAR1.SGM 09JAR1 pwalker on PROD1PC71 with NOTICES 1522 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations value 0.013 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 nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Cypermethrin/zeta-cypermethrin is currently registered for the following residential non-dietary sites: as an indoor surface or spot/crack and crevice treatment; and as a granular broadcast or spot application for lawns. EPA assessed residential exposure using the following assumptions: There is a potential for short- and intermediate-term dermal and inhalation exposure of homeowners applying products containing cypermethrin/zeta-cypermethrin in indoor (surface or crack and crevice treatments) and outdoor (lawn treatment) settings. The outdoor use on lawns, considered the worst case residential handler exposure scenario, was used to assess residential handler exposure and risk. A dermal endpoint of concern for adults was not identified in the toxicology database for cypermethrin/zeta-cypermethrin; therefore, only the inhalation route of exposure was assessed for residential applicators. There is also a potential for short- and intermediate-term dermal and inhalation post-application exposure of adults and short- and intermediate-term dermal, inhalation and incidental oral post-application exposure of children from entering areas treated with cypermethrin/zeta-cypermethrin. As noted above, a dermal endpoint of concern for adults was not identified in the toxicology database for cypermethrin/zeta-cypermethrin. In addition, EPA has determined in previous residential assessments that indoor and outdoor inhalation exposures are negligible, due in part to the low vapor pressure of cypermethrin/ zeta-cypermethrin; therefore, EPA only assessed post-application dermal and incidental oral exposure of children to cypermethrin/zeta-cypermethrin in indoor and outdoor settings. 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.’’ VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 Cypermethrin/zeta-cypermethrin is a member of the pyrethroid class of pesticides. Although all pyrethroids alter nerve function by modifying the normal biochemistry and physiology of nerve membrane sodium channels, EPA is not currently following a cumulative risk approach based on a common mechanism of toxicity for the pyrethroids. Although all pyrethroids interact with sodium channels, there are multiple types of sodium channels and it is currently unknown whether the pyrethroids have similar effects on all channels. Nor do we have a clear understanding of effects on key downstream neuronal function e.g., nerve excitability, nor do we understand how these key events interact to produce their compound-specific patterns of neurotoxicity. There is ongoing research by the EPA’s Office of Research and Development and pyrethroid registrants to evaluate the differential biochemical and physiological actions of pyrethroids in mammals. When available, the Agency will consider this research and make a determination of common mechanism as a basis for assessing cumulative risk. Information regarding EPA’s procedures for cumulating effects from substances found to have a common mechanism can be found on EPA’s website at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (‘‘10X’’) 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 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. 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 FQPA safety factor value based on the use of traditional uncertainty factors (UFs) and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. The pre- and postnatal toxicology database for cypermethrin/zetacypermethrin includes rat and rabbit developmental toxicity studies, a twogeneration reproduction toxicity study in rats and a developmental neurotoxicity (DNT) study in rats. There was no evidence of increased PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 quantitative or qualitative susceptibility of in utero rats or rabbits or offspring following exposure to cypermethrin/ zeta-cypermethrin in the developmental toxicity and reproduction studies. In the DNT study, there was limited evidence of increased susceptibility of the offspring. No toxicity was observed in the maternal animals at the highest dose tested, while decreased body weight, decreased subsession motor activity, and changes in brain morphometry were seen in the offspring at this same dose. An in-depth analysis of the effects seen in the pups revealed that these effects were of low concern because: i. Body weight decreases were seen only during late lactation (postnatal days 13 to 21) when the pups are potentially exposed to higher levels of the chemical via both milk and feed. ii. The decreases in motor activity were not considered biologically significant because they were seen only in the subsession data (not in total or ambulatory counts), only in one sex (females), only on postnatal day 21 (not in measurements taken at three other time periods), and the differences did not reach statistical significance. iii. The sole brain morphometric change (increased mean vertical thickness of the cortex ) was determined to occur in isolation, only in female pups on day 21, and was not considered biologically significant because when the values of individual treated animals were compared with individual control animals, the incidence and magnitude of the change suggested a low concern.No statistically or biologically significant changes were seen in any other brain areas in male or female pups at any time period. Based on these factors, the limited susceptibility seen in the DNT was determined to be of low concern, and there are no residual uncertainties for pre- and/or postnatal neurotoxicity. 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for cypermethrin/zeta-cypermethrin is complete. ii. There is no evidence that cypermethrin/zeta-cypermethrin results in increased qualitative or quantitative susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2–generation reproduction study. iii. Although there is limited evidence of increased susceptibility of the offspring in the DNT study, the degree E:\FR\FM\09JAR1.SGM 09JAR1 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations of concern for pre- and/or postnatal toxicity is low and the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment. iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessment utilizes tolerance level residues and 100 PCT. The chronic dietary food exposure assessment utilizes anticipated residues that are based on reliable field trial or PDP monitoring data. The chronic assessment also utilizes PCT data for many registered commodities that have been verified by the Agency, as well as high-end PPCT estimates for animal feed items that are unlikely to be exceeded during the next 5 years. Conservative ground and surface water modeling estimates were used. Similarly, conservative residential SOPs were used to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cypermethrin/zetacypermethrin. pwalker on PROD1PC71 with NOTICES E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cypermethrin/zeta-cypermethrin will occupy 53% of the aPAD for children, 1 to 2 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to cypermethrin/zetacypermethrin from food and water will utilize 3.0% of the cPAD for children, 1 to 2 years old, the population group with the greatest estimated exposure. Based on the use pattern, chronic residential exposure to residues of cypermethrin/zeta-cypermethrin is not expected. VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 3. Short- and intermediate-term risk. Short-term and intermediate-term aggregate exposure take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Cypermethrin/zeta-cypermethrin is currently registered for uses that could result in short- and intermediate-term residential exposures and the Agency has determined that it is appropriate to aggregate chronic food and water and short- or intermediate-term exposures for cypermethrin/zeta-cypermethrin. Since the cypermethrin/zetacypermethrin endpoints and points of departure (NOAELs) are identical for short- and intermediate-term exposures, in this case the aggregate MOEs for short- and intermediate-term exposure are the same. Using the exposure assumptions described in this unit for short-term and intermediate-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of 7,500 for the overall U.S. population and 8,600 for females 13 to 49 years old, using handler exposure estimates based on indoor surface uses of cypermethrin/ zeta-cypermethrin. Aggregate MOEs for infants and children are estimated to be 220 and 160, respectively, based on post-application exposures following indoor surface treatments with cypermethrin/zeta-cypermethrin. The indoor surface treatment scenario was used in the aggregate assessment, since this scenario resulted in the highest estimated exposures and is, therefore, protective of all post-application exposures. These aggregate MOEs do not exceed the Agency’s level of concern for aggregate exposure to food, water and residential uses. 5. Aggregate cancer risk for U.S. population. Cypermethrin/zetacypermethrin has been classified as a ‘‘Group C’’ (possible human) carcinogen, based on an increased incidence of lung adenomas and combined adenomas plus carcinomas in female mice. As explained above, risk assessments based on the endpoint selected for the chronic population adjusted dose (cPAD) are considered to be protective of any potential carcinogenic risk from exposure to cypermethrin/zeta-cypermethrin. Based on the results of the chronic risk assessment discussed above in Unit III.E.2., EPA concludes that cypermethrin/zeta-cypermethrin is not expected to pose a cancer risk. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 1523 population, or to infants and children from aggregate exposure to cypermethrin/zeta-cypermethrin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement analytical methodology for cypermethrin and zetacypermethrin residues is available in PAM Volume II. PAM Volume II lists Methods I and II for the determination of residues of cypermethrin per se in or on plant and livestock commodities, respectively. Both are gas chromatography (GC) methods with electron capture detection and have undergone successful Agency method tryout. Method I has a detection limit of 0.01 ppm and Method II has detection limits of 0.005 ppm for milk and 0.01 ppm for livestock tissues. These methods are not stereo-specific; thus, no distinction is made between residues of cypermethrin (all eight stereoisomers) and zeta-cypermethrin (an enriched isomer form of cypermethrin). B. International Residue Limits There are no specific Codex maximum residue limits (MRLs) for zeta-cypermethrin, but there are Codex MRLs for cypermethrin. Codex has an MRL of 2.0 ppm for cypermethrin on citrus, an MRL of 0.2 ppm on oilseeds and an MRL of 0.5 ppm on edible vegetable oils. The 0.2 ppm U.S. tolerances on safflower and other oilseeds are harmonized numerically with the current Codex MRL of 0.2 mg/ kg on oilseeds, although the latter is based on cypermethrin instead of zetacypermethrin. EPA is not recommending an increase in the U.S. citrus tolerance of 0.35 ppm or the tolerance on refined oils of 0.4 ppm to harmonize numerically with the Codex MRLs on citrus and edible vegetable oils, because the latter are expressed in terms of cypermethrin, which requires higher application rates and residues than zeta-cypermethrin to be efficacious. C. Response to Comments Comments were received from a private citizen objecting to the sale of zeta-cypermethrin anywhere in this country on the basis that it is a ‘‘possible human carcinogen’’. EPA considered the carcinogenic potential of zeta-cypermethrin in its risk assessment and determined that it did not pose a cancer risk. Comments received contained no scientific data or other substantive evidence to rebut this conclusion or the Agency’s finding that there is a reasonable certainty that no E:\FR\FM\09JAR1.SGM 09JAR1 1524 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations pwalker on PROD1PC71 with NOTICES harm will result from aggregate exposure to cypermethrin/zetacypermethrin from the establishment of these tolerances. The Agency has received these same or similar comments from this commenter on numerous previous occasions. Refer to 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), and 69 FR 6309663098 (October 29, 2004) for the Agency’s previous responses to these objections. V. Conclusion Based upon review of the data supporting the petitions, EPA has modified the proposed tolerances as follows: (1) Increased the tolerance level for Fruit, citrus, group 10 from 0.25 ppm to 0.35 ppm; for Citrus, dried pulp from 0.5 ppm to 1.8 ppm; and for Citrus, oil from 0.9 ppm to 4.0 ppm; and (2) Determined that a separate, higher tolerance of 0.4 ppm should be established for specific refined oils. EPA revised these tolerance levels based on analyses of the residue field trial data using the Agency’s Tolerance Spreadsheet in accordance with the Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data and the results of citrus and oilseed processing studies. EPA also revised the commodity term for Safflower to read ‘‘Safflower, seed’’ to agree with the recommended commodity term in the Office of Pesticide Program’s Food and Feed Commodity Vocabulary. Therefore, tolerances are established for combined residues of zetacypermethrin, S-cyano(3phenoxyphenyl)methyl(±)(cis-trans 3(2,2-dichloroethenyl)-2,2dimethylcyclopropanecarboxylate and its inactive R-isomers, in or on Borage, seed at 0.2 ppm; Castor oil plant, refined oil at 0.4 ppm; Castor oil plant, seed at 0.2 ppm; Chinese tallowtree, refined oil at 0.4 ppm; Chinese tallowtree, seed at 0.2 ppm; Citrus, dried pulp at 1.8 ppm; Citrus, oil at 4.0 ppm; Crambe, seed at 0.2 ppm; Cuphea, seed at 0.2 ppm; Echium, seed at 0.2 ppm; Euphorbia, refined oil at 0.4 ppm; Euphorbia, seed at 0.2 ppm; Evening primrose, refined oil at 0.4 ppm; Evening primrose, seed at 0.2 ppm; Flax, seed at 0.2 ppm; Fruit, citrus, group 10 at 0.35 ppm; Gold of pleasure, seed at 0.2 ppm; Hare’s-ear mustard, seed at 0.2 ppm; Jojoba, refined oil at 0.4 ppm; Jojoba, seed at 0.2 ppm; Lesquerella, seed at 0.2 ppm; Lunaria, seed at 0.2 pm; Meadowfoam, seed at 0.2 ppm; Milkweed, seed at 0.2 ppm; Mustard, seed at 0.2 ppm; Niger seed, refined oil at 0.4 ppm; Niger seed, seed at 0.2 ppm; Oil radish, seed at 0.2 ppm; Okra at 0.2 ppm; Poppy, seed at 0.2 ppm; Rice, wild, grain at 1.5 ppm; VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 Rose hip, refined oil at 0.4 ppm; Rose hip, seed at 0.2 ppm; Safflower, seed at 0.2 ppm; Sesame, seed at 0.2 ppm; Stokes aster, refined oil at 0.4 ppm; Stokes aster, seed at 0.2 ppm; Sweet rocket, seed at 0.2 ppm; Tallowwood, refined oil at 0.4 ppm; Tallowwood, seed at 0.2 ppm; Tea oil plant, refined oil at 0.4 ppm; Tea oil plant, seed at 0.2 ppm; Vernonia, refined oil at 0.4 ppm; and Vernonia, seed at 0.2 ppm. Time-limited tolerances were established at 40 CFR 180.418(b) for residues of zeta-cypermethrin in or on flax, meal and seed in connection with FIFRA section 18 emergency exemptions granted by EPA. These timelimited tolerances are no longer necessary, because a permanent tolerance is being established for flax at the same level. Therefore, these timelimited tolerances for residues of zetacypermethrin are revoked. 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, 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) 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 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 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 6, 2000) do not apply to this rule. In addition, This 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 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 20, 2007. Lois Rossi Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I E:\FR\FM\09JAR1.SGM 09JAR1 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations PART 180—[AMENDED] Parts per million Commodity 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.418 is amended by alphabetically adding the following commodities to the table in paragraph (a)(2) and removing the text from paragraph (b) and reserving the paragraph designation and heading to read as follows: I § 180.418 Cypermethrin and an isomer zeta-cypermethrin; tolerances for residues. (a) * * * (2) * * * pwalker on PROD1PC71 with NOTICES Commodity * * * Borage, seed ........................ * * * Castor oil plant, refined oil ... Castor oil plant, seed ........... * * * Chinese tallowtree, refined oil ....................................... Chinese tallowtree, seed ...... * * * Citrus, dried pulp .................. Citrus, oil ............................... * * * Crambe, seed ....................... Cuphea, seed ....................... Echium, seed ........................ * * * Euphorbia, refined oil ........... Euphorbia, seed ................... Evening primrose, refined oil Evening primrose, seed ........ Flax, seed ............................. * * * Fruit, citrus, group 10 ........... * * * Gold of pleasure, seed ......... * * * Hare’s-ear mustard, seed ..... * * * Jojoba, refined oil ................. Jojoba, seed ......................... Lesquerella, seed ................. Lunaria, seed ........................ Meadowfoam, seed .............. * * * Milkweed, seed ..................... Mustard, seed ....................... Niger seed, refined oil .......... Niger seed, seed .................. * * * Oil radish, seed .................... Okra ...................................... * * * Poppy, seed .......................... * * * Rice, wild, grain .................... Rose hip, refined oil ............. Rose hip, seed ..................... Safflower, seed ..................... Sesame, seed ....................... * * * Stokes aster, refined oil ........ Stokes aster, seed ................ VerDate Aug<31>2005 15:44 Jan 08, 2008 * * * Sweet rocket, seed ............... Tallowwood, refined oil ......... Tallowwood, seed ................. Tea oil plant, refined oil ........ Tea oil plant, seed ................ * * * Vernonia, refined oil ............. Vernonia, seed ..................... * * * * * 0.2 0.4 0.2 0.4 0.2 * * 0.4 0.2 * * (b) Section 18 emergency exemptions. [Reserved] * * * * * [FR Doc. E7–25392 Filed 1–8–08; 8:45 am] Parts per million * DEPARTMENT OF THE INTERIOR * 0.2 * * 0.4 0.2 * * 0.4 0.2 * BILLING CODE 6560–50–S * Fish and Wildlife Service 50 CFR Part 17 [FWS–R8–ES–2007–0026; 92210–1117– 0000; ABC Code: B4] RIN 1018–AU83 1.8 4.0 * Endangered and Threatened Wildlife and Plants; Designation of Critical * Habitat for the Monterey Spineflower 0.2 (Chorizanthe pungens var. pungens) 0.2 * * 0.2 0.4 0.2 0.2 * * * * * * * * * Jkt 214001 AGENCY: SUMMARY: We, the U.S. Fish and Wildlife Service (Service), are designating revised critical habitat for the threatened Monterey spineflower (Chorizanthe pungens var. pungens) under the Endangered Species Act of 1973, as amended (Act). In total, approximately 11,055 acres (ac) (4,475 hectares (ha)) fall within the boundaries of this revised critical habitat designation. The revised critical habitat is located in Santa Cruz and Monterey counties, California. DATES: This rule becomes effective on February 8, 2008. ADDRESSES: Comments and materials we received, as well as supporting documentation we used in the preparation of this final rule, are available for public inspection, by appointment, during normal business hours at the Ventura Fish and Wildlife Office, 2493 Portola Road, Suite B, Ventura, CA 93003 (telephone 805–644– 1766). The final rule, economic analysis, and more detailed maps are also available on the Internet at http:// www.fws.gov/ventura. FOR FURTHER INFORMATION CONTACT: Connie Rutherford, Listing and Fish and Wildlife Service, Interior. 0.4 0.2 ACTION: Final rule. * 0.35 * 0.2 * 0.2 * 0.4 0.2 0.2 0.2 0.2 * 0.2 0.2 0.4 0.2 * 0.2 0.2 * 0.2 * 1.5 0.4 0.2 0.2 0.2 * 0.4 0.2 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 1525 Recovery Coordinator for Plants, Ventura Fish and Wildlife Office (see ADDRESSES), (telephone 805–644–1766, ext. 306; facsimile 805–644–3958). If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800–877–8339. SUPPLEMENTARY INFORMATION: Background It is our intent to discuss only those topics directly relevant to the designation of revised critical habitat in this rule. For more detailed background information on the appearance, seed ecology, habitat requirements, and the historical and current distribution of Chorizanthe pungens var. pungens, refer to the proposed revised critical habitat designation published in the Federal Register on December 14, 2006 (71 FR 75189), and the previous final designation of critical habitat for C. p. var. pungens published in the Federal Register on May 29, 2002 (67 FR 37498). Additional information on C. p. var. pungens is also available in the final listing rule published in the Federal Register on February 4, 1994 (59 FR 5499). Chorizanthe pungens var. pungens is an annual species in the buckwheat family (Polygonaceae). It is a lowgrowing herb that is soft-hairy and grayish or reddish in color, with whiteto rose-colored flowers. It produces one seed per flower, and depending on the vigor of an individual plant, dozens to over one hundred seeds can be produced (Abrams 1944, F35–1; Fox et al. 2006, pp. 162–163). Seed dispersal in C. p. var. pungens is likely facilitated by hooked spines on the structure surrounding the seed. In the Chorizanthe genus, these are believed to attach to passing animals and disperse seed between plant colonies and populations (Reveal 2001, unpaginated). Wind also disperses seed within colonies and populations. Previous Federal Actions On May 29, 2002, we designated critical habitat for Chorizanthe pungens var. pungens on approximately 18,829 acres (ac) (7,620 hectares (ha)) of land in Santa Cruz and Monterey counties, California (67 FR 37498). In March 2005, the Homebuilders Association of Northern California, et al., filed suit against the Service (CV–013630LKK– JFM) challenging final critical habitat rules for several species, including Chorizanthe pungens var. pungens. In March 2006, a settlement was reached that requires the Service to re-evaluate five final critical habitat designations, including critical habitat designated for E:\FR\FM\09JAR1.SGM 09JAR1

Agencies

[Federal Register Volume 73, Number 6 (Wednesday, January 9, 2008)]
[Rules and Regulations]
[Pages 1517-1525]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25392]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0300; FRL-8346-3]


Zeta-cypermethrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of zeta-cypermethrin and its inactive R-isomers in or on Citrus (dried 
pulp, fruit and oil); oilseed commodities (seeds of borage, castor oil 
plant, Chinese tallow tree, crambe, cuphea, echium, euphorbia, evening 
primrose, flax, gold of pleasure, hare's-ear mustard, jojoba,

[[Page 1518]]

lesquerella, lunaria, meadowfoam, milkweed, mustard, niger seed, oil 
radish, poppy, rose hip, sesame, Stokes aster, sweet rocket, 
tallowwood, tea oil plant, and vernonia); oilseed, refined oils 
(refined oils of castor oil plant, Chinese tallowtree, euphorbia, 
evening primrose, jojoba, niger seed, rose hip, stokes aster, 
tallowwood, tea oil plant and vernonia); okra; rice, wild; and 
safflower, seed. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA). This regulation also deletes time-limited flax seed 
tolerances which are made redundant and unnecessary by establishment of 
the permanent tolerance on flax seed.

DATES: This regulation is effective January 9, 2008. Objections and 
requests for hearings must be received on or before March 10, 2008, 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-2007-0300. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 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 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 EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0300 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 as required by 40 CFR part 178 on or 
before March 10, 2008.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0300, 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'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. Petition for Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35237-35242) (FRL-
8133-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
6E7132 and PP 6E7133) by Interregional Research Project Number 4 (IR-
4), 500 College Road East, Suite 201 W, Princeton, NJ 08540-6635. The 
petitions requested that 40 CFR 180.418 be amended by establishing 
tolerances for combined residues of the insecticide zeta-cypermethrin, 
S-cyano(3-phenoxyphenyl) methyl ()-cis-trans 3-(2,2-
dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate and its inactive 
R-isomers, in or on the following food commodities: PP 6E7132 - Rice, 
wild, grain at 1.50 parts per million (ppm); okra at 0.20 ppm;

[[Page 1519]]

safflower, seed at 0.20 ppm; and PP 6E7133 - Fruit, citrus, group 10 at 
0.25 ppm; citrus, dried, pulp at 0.50 ppm; and citrus, oil at 0.90 ppm. 
That notice referenced a summary of the petition prepared by FMC 
Corporation, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    In the Federal Register of October 24, 2007 (72 FR 60369-60371) 
(FRL-8150-8), 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 7E7255) by Interregional Research Project Number 4 (IR-4), 
500 College Road East, Suite 201 W, Princeton, NJ 08540-6635. The 
petition requested that 40 CFR 180.418 be amended by establishing 
tolerances for combined residues of the insecticide zeta-cypermethrin, 
S-cyano(3-phenoxyphenyl) methyl ()-cis-trans 3-(2,2-
dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate and its inactive 
R-isomers, at 0.2 ppm in or on the following commodities: borage, seed; 
castor oil plant, seed; Chinese tallowtree, seed; crambe, seed; cuphea, 
seed; echium, seed; euphorbia, seed; evening primrose, seed; flax, 
seed; gold of pleasure, seed; hare's ear mustard, seed; jojoba, seed; 
lesquerella, seed; lunaria, seed; meadowfoam, seed; milkweed, seed; 
mustard, seed; niger seed, seed; oil radish, seed; poppy, seed; rose 
hip, seed; sesame, seed; Stokes aster, seed; sweet rocket, seed; 
tallowwood, seed; tea oil plant, seed; and vernonia, seed. That notice 
referenced a summary of the petition prepared by FMC Corporation, the 
registrant, which is available to the public in the docket, http://
www.regulations.gov. Comments were received from a private citizen on 
the notice of filing. EPA's response to these comments is discussed in 
Unit IV.C. below.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance levels for citrus commodities and determined that 
a separate tolerance is needed for refined oils derived from several of 
the proposed oilseed crops. The reason for these changes is explained 
in Unit V.

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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 the petitioned-for tolerance 
for combined residues of zeta-cypermethrin and its inactive R-isomers 
on Borage, seed at 0.2 ppm; Castor oil plant, refined oil at 0.4 ppm; 
Castor oil plant, seed at 0.2 ppm; Chinese tallowtree, refined oil at 
0.4 ppm; Chinese tallowtree, seed at 0.2 ppm; Citrus, dried pulp at 1.8 
ppm; Citrus, oil at 4.0 ppm; Crambe, seed at 0.2 ppm; Cuphea, seed at 
0.2 ppm; Echium, seed at 0.2 ppm; Euphorbia, refined oil at 0.4 ppm; 
Euphorbia, seed at 0.2 ppm; Evening primrose, refined oil at 0.4 ppm; 
Evening primrose, seed at 0.2 ppm; Flax, seed at 0.2 ppm; Fruit, 
citrus, group 10 at 0.35 ppm; Gold of pleasure, seed at 0.2 ppm; 
Hare's-ear mustard, seed at 0.2 ppm; Jojoba, refined oil at 0.4 ppm; 
Jojoba, seed at 0.2 ppm; Lesquerella, seed at 0.2 ppm; Lunaria, seed at 
0.2 pm; Meadowfoam, seed at 0.2 ppm; Milkweed, seed at 0.2 ppm; 
Mustard, seed at 0.2 ppm; Niger seed, refined oil at 0.4 ppm; Niger 
seed, seed at 0.2 ppm; Oil radish, seed at 0.2 ppm; Okra at 0.2 ppm; 
Poppy, seed at 0.2 ppm; Rice, wild, grain at 1.5 ppm; Rose hip, refined 
oil at 0.4 ppm; Rose hip, seed at 0.2 ppm; Safflower, seed at 0.2 ppm; 
Sesame, seed at 0.2 ppm; Stokes aster, refined oil at 0.4 ppm; Stokes 
aster, seed at 0.2 ppm; Sweet rocket, seed at 0.2 ppm; Tallowwood, 
refined oil at 0.4 ppm; Tallowwood, seed at 0.2 ppm; Tea oil plant, 
refined oil at 0.4 ppm; Tea oil plant, seed at 0.2 ppm; Vernonia, 
refined oil at 0.4 ppm; and Vernonia, seed at 0.2 ppm. EPA's assessment 
of exposures and risks associated with establishing the tolerance 
follows.
    Zeta-cypermethrin is an enriched version of the synthetic 
pyrethroid insecticide cypermethrin. Cypermethrin [() 
[alpha]-cyano-(3-phenoxyphenyl)methyl ()-cis, trans-3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate] is a racemic 
mixture of eight isomers (each with percentages of 11-14%). Zeta-
cypermethrin consists primarily of the four isomers with the ``S'' 
configuration at the cyano-bearing carbon. While cypermethrin and zeta-
cypermethrin are separate active ingredients, each registered in 
separate end-use products, they are considered together in this risk 
assessment due to the close similarity of their uses, toxicity, and 
chemical characteristics.

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 adverse effects caused by cypermethrin/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 at http://www.regulations.gov in the document Zeta-cypermethrin: 
Human Health Risk Assessment for Section 3 Use of Zeta-cypermethrin on 
Citrus (Crop Group 10), Oilseeds (proposed Crop Group 20, except 
cottonseed), Safflower, Wild Rice and Okra. The referenced document is 
available in the docket established by this action, which is described 
under ADDRESSES and is identified as document ID number EPA-HQ-OPP-
2007-0300-0006 in that docket.
    The toxicity data for zeta-cypermethrin indicate one major target 
for this chemical: the neuromuscular system. There may be some liver 
effects as well; however, these may be an adaptive response. The 
neuromuscular effects (tremors, gait abnormalities, and decreases in 
motor activity) occur mainly in oral studies in the dog and the rat. 
Similar effects were observed in a rat inhalation study conducted with 
cypermethrin. As with other pyrethroids, the neuromuscular effects 
appear to be transient acute effects and do not appear to increase in 
severity with increasing duration of exposure.
    Studies on zeta-cypermethrin, in addition to those on cypermethrin,

[[Page 1520]]

show that it is not a developmental or reproductive toxicant. In the 
prenatal developmental toxicity studies in rats and rabbits, there was 
no evidence of developmental toxicity up to the highest dose tested. 
Maternal toxicity was observed in these studies in the form of 
decreased body weight gain and food consumption and/or clinical signs 
of neurotoxicity such as gait abnormalities. In the multi-generation 
reproduction studies in rats, offspring toxicity was observed at the 
same treatment level that resulted in parental systemic toxicity. There 
did not appear to be any increases in severity of toxicity for the pups 
in these studies. In the developmental neurotoxicity (DNT) study, there 
was limited evidence of increased susceptibility of the offspring. No 
toxicity was observed in the maternal animals at the highest dose 
tested, while decreased body weight, decreased subsession motor 
activity, and changes in brain morphometry were seen in the offspring 
at this same dose. With the available toxicity database at this time, 
there is no evidence of endocrine disruption.
    EPA has classified cypermethrin/zeta-cypermethrin as a possible 
human carcinogen, based on an increased incidence of lung adenomas and 
combined adenomas plus carcinomas in female mice. The presence of 
common benign tumors (lung adenomas) in one species (mice) and one sex 
(female), with no increase in the proportion of malignant tumors or 
decrease in the time-to-tumor occurrence, together with the lack of 
mutagenic activity, was not considered strong enough evidence to 
warrant a quantitative estimation of human cancer risk. The point-of-
departure selected for deriving the chronic reference dose will account 
for all chronic effects as well as potential cancer effects.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
uncertainty factors (UFs) is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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 zeta-cypermethrin/
cypermethrin used for human risk assessment can be found at http://
www.regulations.gov at pages 25-26 in the document Zeta-cypermethrin: 
Human Health Risk Assessment for Section 3 Use of Zeta-cypermethrin on 
Citrus (Crop Group 10), Oilseeds (proposed Crop Group 20, except 
cottonseed), Safflower, Wild Rice and Okra in docket ID number EPA-HQ-
OPP-2007-0300.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cypermethrin/zeta-cypermethrin, EPA considered exposure 
under the petitioned-for tolerances as well as all existing 
cypermethrin/zeta-cypermethrin tolerances in 40 CFR 180.418. 
Cypermethrin and zeta-cypermethrin are registered for use on some of 
the same commodities; however, when both are applied to the same crop 
in the same year, the maximum seasonal rate may not exceed the maximum 
seasonal rate for cypermethrin when used alone. Therefore, EPA has not 
assumed that residues of both cypermethrin and zeta-cypermethrin would 
appear on the same crop. EPA assessed dietary exposures from 
cypermethrin/zeta-cypermethrin 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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed all foods for which 
there are tolerances were treated and contain tolerance-level residues. 
For crops with both cypermethrin and zeta-cypermethrin tolerances, the 
higher of the two tolerances was assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA calculated 
anticipated residues for most commodities. Anticipated residues were 
based on USDA Pesticide Data Program (PDP) monitoring data or crop 
field trial data and in many cases were further adjusted to reflect 
actual percent crop treated (PCT) estimates. For crops with both 
cypermethrin and zeta-cypermethrin registrations, the higher of the two 
PCT estimates was assumed. EPA assumed 100 PCT for all of the new uses. 
Anticipated residues were calculated for livestock commodities using 
the residue data from livestock feeding studies in conjunction with 
anticipated dietary burdens from consumption of cypermethrin/zeta-
cypermethrin treated feed items. Projected PCT (PPCT) estimates were 
used in these calculations for certain recently registered feed items 
(alfalfa hay, other hay and pasture/rangeland grasses), since reliable 
PCT estimates based on historical usage are not yet available.
    iii. Cancer. As discussed above in Unit III.A., EPA has classified 
cypermethrin/zeta-cypermethrin as a possible human carcinogen (Group 
C), based on an increased incidence of lung adenomas and combined 
adenomas plus carcinomas in female mice. EPA determined that the 
Chronic Reference Dose (cRfD) would be protective of any cancer risk 
posed by zeta-cypermethrin because the cRfD of 0.06 milligrams/
kilogram/day (mg/kg/day) (based on a NOAEL of 6 mg/kg/day) used for 
risk assessment is significantly lower than the dose of 1,600 ppm 
(approximately 229 mg/kg/day) at which tumors were observed; the NOAEL 
for tumor induction is 400 ppm (approximately 57 mg/kg/day). EPA also 
took into account that the benign tumors (lung adenomas) were observed 
in one species (mice) and one sex (female), with no increase in the 
proportion of malignant tumors or decrease in the time-to-tumor

[[Page 1521]]

occurrence. Together with the lack of mutagenic activity, there was not 
strong enough evidence to warrant a quantitative estimation of human 
cancer risk. Therefore, the cRfD is considered protective of both non-
cancer and cancer effects and a separate cancer exposure assessment was 
not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of 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 residues that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to FFDCA 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. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data 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:
     Condition a. 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 b. The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c. 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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information in the chronic dietary exposure 
assessment as follows:
    PCT estimates for existing uses: broccoli 6%, cabbage 3%, carrots 
1%, cauliflower 13%, collards 9%, celery 1%, corn (field and sweet) 
<1%, cotton 5%, garlic 13%, kale 13%, lettuce (head and leaf) 26%, 
mustard greens 8%, onions 15%, peanuts <1%, pecans 9%, sorghum <1%, 
soybeans <1%, spinach 2%, tomato 1%, turnip greens 4% and wheat <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 5% except for those situations in which the average 
PCT is less than one. In those cases <1% is used as the average. In 
most cases, EPA uses available data from U. S. 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.
    EPA used Projected PCT (PPCT) estimates for animal feed items: 
alfalfa hay 3%, other hay 1% and pasture/rangeland <1%.
    EPA estimates PPCT for a new pesticide use by assuming that the PCT 
during the pesticide's initial 5 years of use on a specific use site 
will not exceed the average PCT of the market leader (i.e., the one 
with the greatest PCT) on that site over the three most recent surveys. 
Comparisons are only made among pesticides of the same pesticide types 
(i.e., the dominant insecticide on the use site is selected for 
comparison with the new insecticide). The PCTs included in the average 
may be each for the same pesticide or for different pesticides since 
the same or different pesticides may dominate for each year selected. 
Typically, EPA uses USDA/NASS as the source for the PCT data because 
they are publicly available. When a specific use site is not surveyed 
by USDA/NASS, EPA uses proprietary data and calculates the estimated 
PCT.
    This estimated PPCT, based on the average PCT of the market leader, 
is appropriate for use in the chronic dietary risk assessment. This 
method of estimating a PPCT for a new use of a registered pesticide or 
a new pesticide produces a high-end estimate that is unlikely, in most 
cases, to be exceeded during the initial 5 years of actual use. 
Predominant factors that bear on whether the estimated PPCT for these 
three crops could be exceeded include pest resistance concerns, 
relative efficacies, pest prevalence and other factors. All such 
relevant information that is currently available to EPA has been 
considered for zeta-cypermethrin on alfalfa hay, other hay and pasture/
rangeland. It is unlikely that the actual PCT for zeta-cypermethrin 
will exceed the estimated PPCT for this chemical on each of these three 
sites during the next 5 years.
    The Agency believes that the three conditions listed in this Unit 
have been met. With respect to Condition a, PCT estimates are derived 
from Federal and private market survey data, which are reliable and 
have a valid basis. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation. 
As to Conditions b and c, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which cypermethrin/
zeta-cypermethrin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for cypermethrin/zeta-cypermethrin 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 
environmental fate characteristics of cypermethrin/zeta-cypermethrin. 
Further information regarding EPA's 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 environmental concentrations (EECs) of 
cypermethrin/zeta-cypermethrin for acute exposures are estimated to be 
1.04 parts per billion (ppb) for surface water and 0.0036 ppb for 
ground water. The EECs for chronic exposures are estimated to be 0.013 
ppb for surface water and 0.0036 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 1.04 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of

[[Page 1522]]

value 0.013 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).
    Cypermethrin/zeta-cypermethrin is currently registered for the 
following residential non-dietary sites: as an indoor surface or spot/
crack and crevice treatment; and as a granular broadcast or spot 
application for lawns. EPA assessed residential exposure using the 
following assumptions:
    There is a potential for short- and intermediate-term dermal and 
inhalation exposure of homeowners applying products containing 
cypermethrin/zeta-cypermethrin in indoor (surface or crack and crevice 
treatments) and outdoor (lawn treatment) settings. The outdoor use on 
lawns, considered the worst case residential handler exposure scenario, 
was used to assess residential handler exposure and risk. A dermal 
endpoint of concern for adults was not identified in the toxicology 
database for cypermethrin/zeta-cypermethrin; therefore, only the 
inhalation route of exposure was assessed for residential applicators.
    There is also a potential for short- and intermediate-term dermal 
and inhalation post-application exposure of adults and short- and 
intermediate-term dermal, inhalation and incidental oral post-
application exposure of children from entering areas treated with 
cypermethrin/zeta-cypermethrin. As noted above, a dermal endpoint of 
concern for adults was not identified in the toxicology database for 
cypermethrin/zeta-cypermethrin. In addition, EPA has determined in 
previous residential assessments that indoor and outdoor inhalation 
exposures are negligible, due in part to the low vapor pressure of 
cypermethrin/zeta-cypermethrin; therefore, EPA only assessed post-
application dermal and incidental oral exposure of children to 
cypermethrin/zeta-cypermethrin in indoor and outdoor settings.
    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.''
    Cypermethrin/zeta-cypermethrin is a member of the pyrethroid class 
of pesticides. Although all pyrethroids alter nerve function by 
modifying the normal biochemistry and physiology of nerve membrane 
sodium channels, EPA is not currently following a cumulative risk 
approach based on a common mechanism of toxicity for the pyrethroids. 
Although all pyrethroids interact with sodium channels, there are 
multiple types of sodium channels and it is currently unknown whether 
the pyrethroids have similar effects on all channels. Nor do we have a 
clear understanding of effects on key downstream neuronal function 
e.g., nerve excitability, nor do we understand how these key events 
interact to produce their compound-specific patterns of neurotoxicity. 
There is ongoing research by the EPA's Office of Research and 
Development and pyrethroid registrants to evaluate the differential 
biochemical and physiological actions of pyrethroids in mammals. When 
available, the Agency will consider this research and make a 
determination of common mechanism as a basis for assessing cumulative 
risk. Information regarding EPA's procedures for cumulating effects 
from substances found to have a common mechanism can be found on EPA's 
website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') 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 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. 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 FQPA 
safety factor value based on the use of traditional uncertainty factors 
(UFs) and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The pre- and postnatal 
toxicology database for cypermethrin/zeta-cypermethrin includes rat and 
rabbit developmental toxicity studies, a two-generation reproduction 
toxicity study in rats and a developmental neurotoxicity (DNT) study in 
rats. There was no evidence of increased quantitative or qualitative 
susceptibility of in utero rats or rabbits or offspring following 
exposure to cypermethrin/zeta-cypermethrin in the developmental 
toxicity and reproduction studies.
    In the DNT study, there was limited evidence of increased 
susceptibility of the offspring. No toxicity was observed in the 
maternal animals at the highest dose tested, while decreased body 
weight, decreased subsession motor activity, and changes in brain 
morphometry were seen in the offspring at this same dose. An in-depth 
analysis of the effects seen in the pups revealed that these effects 
were of low concern because:
    i. Body weight decreases were seen only during late lactation 
(postnatal days 13 to 21) when the pups are potentially exposed to 
higher levels of the chemical via both milk and feed.
    ii. The decreases in motor activity were not considered 
biologically significant because they were seen only in the subsession 
data (not in total or ambulatory counts), only in one sex (females), 
only on postnatal day 21 (not in measurements taken at three other time 
periods), and the differences did not reach statistical significance.
    iii. The sole brain morphometric change (increased mean vertical 
thickness of the cortex ) was determined to occur in isolation, only in 
female pups on day 21, and was not considered biologically significant 
because when the values of individual treated animals were compared 
with individual control animals, the incidence and magnitude of the 
change suggested a low concern.No statistically or biologically 
significant changes were seen in any other brain areas in male or 
female pups at any time period.
    Based on these factors, the limited susceptibility seen in the DNT 
was determined to be of low concern, and there are no residual 
uncertainties for pre- and/or postnatal neurotoxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for cypermethrin/zeta-cypermethrin is 
complete.
    ii. There is no evidence that cypermethrin/zeta-cypermethrin 
results in increased qualitative or quantitative susceptibility in in 
utero rats or rabbits in the prenatal developmental studies or in young 
rats in the 2-generation reproduction study.
    iii. Although there is limited evidence of increased susceptibility 
of the offspring in the DNT study, the degree

[[Page 1523]]

of concern for pre- and/or postnatal toxicity is low and the Agency did 
not identify any residual uncertainties after establishing toxicity 
endpoints and traditional UFs to be used in the risk assessment.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessment utilizes 
tolerance level residues and 100 PCT. The chronic dietary food exposure 
assessment utilizes anticipated residues that are based on reliable 
field trial or PDP monitoring data. The chronic assessment also 
utilizes PCT data for many registered commodities that have been 
verified by the Agency, as well as high-end PPCT estimates for animal 
feed items that are unlikely to be exceeded during the next 5 years. 
Conservative ground and surface water modeling estimates were used. 
Similarly, conservative residential SOPs were used to assess post-
application exposure of children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by cypermethrin/zeta-cypermethrin.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to cypermethrin/zeta-cypermethrin will occupy 53% of the aPAD for 
children, 1 to 2 years old, the population group receiving the greatest 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
cypermethrin/zeta-cypermethrin from food and water will utilize 3.0% of 
the cPAD for children, 1 to 2 years old, the population group with the 
greatest estimated exposure. Based on the use pattern, chronic 
residential exposure to residues of cypermethrin/zeta-cypermethrin is 
not expected.
    3. Short- and intermediate-term risk. Short-term and intermediate-
term aggregate exposure take into account residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). Cypermethrin/zeta-cypermethrin is currently registered 
for uses that could result in short- and intermediate-term residential 
exposures and the Agency has determined that it is appropriate to 
aggregate chronic food and water and short- or intermediate-term 
exposures for cypermethrin/zeta-cypermethrin. Since the cypermethrin/
zeta-cypermethrin endpoints and points of departure (NOAELs) are 
identical for short- and intermediate-term exposures, in this case the 
aggregate MOEs for short- and intermediate-term exposure are the same.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food, 
water, and residential exposures aggregated result in aggregate MOEs of 
7,500 for the overall U.S. population and 8,600 for females 13 to 49 
years old, using handler exposure estimates based on indoor surface 
uses of cypermethrin/zeta-cypermethrin. Aggregate MOEs for infants and 
children are estimated to be 220 and 160, respectively, based on post-
application exposures following indoor surface treatments with 
cypermethrin/zeta-cypermethrin. The indoor surface treatment scenario 
was used in the aggregate assessment, since this scenario resulted in 
the highest estimated exposures and is, therefore, protective of all 
post-application exposures. These aggregate MOEs do not exceed the 
Agency's level of concern for aggregate exposure to food, water and 
residential uses.
    5. Aggregate cancer risk for U.S. population. Cypermethrin/zeta-
cypermethrin has been classified as a ``Group C'' (possible human) 
carcinogen, based on an increased incidence of lung adenomas and 
combined adenomas plus carcinomas in female mice. As explained above, 
risk assessments based on the endpoint selected for the chronic 
population adjusted dose (cPAD) are considered to be protective of any 
potential carcinogenic risk from exposure to cypermethrin/zeta-
cypermethrin. Based on the results of the chronic risk assessment 
discussed above in Unit III.E.2., EPA concludes that cypermethrin/zeta-
cypermethrin is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to cypermethrin/zeta-cypermethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement analytical methodology for cypermethrin and 
zeta-cypermethrin residues is available in PAM Volume II. PAM Volume II 
lists Methods I and II for the determination of residues of 
cypermethrin per se in or on plant and livestock commodities, 
respectively. Both are gas chromatography (GC) methods with electron 
capture detection and have undergone successful Agency method tryout. 
Method I has a detection limit of 0.01 ppm and Method II has detection 
limits of 0.005 ppm for milk and 0.01 ppm for livestock tissues. These 
methods are not stereo-specific; thus, no distinction is made between 
residues of cypermethrin (all eight stereoisomers) and zeta-
cypermethrin (an enriched isomer form of cypermethrin).

B. International Residue Limits

    There are no specific Codex maximum residue limits (MRLs) for zeta-
cypermethrin, but there are Codex MRLs for cypermethrin. Codex has an 
MRL of 2.0 ppm for cypermethrin on citrus, an MRL of 0.2 ppm on 
oilseeds and an MRL of 0.5 ppm on edible vegetable oils. The 0.2 ppm 
U.S. tolerances on safflower and other oilseeds are harmonized 
numerically with the current Codex MRL of 0.2 mg/kg on oilseeds, 
although the latter is based on cypermethrin instead of zeta-
cypermethrin. EPA is not recommending an increase in the U.S. citrus 
tolerance of 0.35 ppm or the tolerance on refined oils of 0.4 ppm to 
harmonize numerically with the Codex MRLs on citrus and edible 
vegetable oils, because the latter are expressed in terms of 
cypermethrin, which requires higher application rates and residues than 
zeta-cypermethrin to be efficacious.

C. Response to Comments

    Comments were received from a private citizen objecting to the sale 
of zeta-cypermethrin anywhere in this country on the basis that it is a 
``possible human carcinogen''. EPA considered the carcinogenic 
potential of zeta-cypermethrin in its risk assessment and determined 
that it did not pose a cancer risk. Comments received contained no 
scientific data or other substantive evidence to rebut this conclusion 
or the Agency's finding that there is a reasonable certainty that no

[[Page 1524]]

harm will result from aggregate exposure to cypermethrin/zeta-
cypermethrin from the establishment of these tolerances. The Agency has 
received these same or similar comments from this commenter on numerous 
previous occasions. Refer to 70 FR 37686 (June 30, 2005), 70 FR 1354 
(January 7, 2005), and 69 FR 63096-63098 (October 29, 2004) for the 
Agency's previous responses to these objections.

V. Conclusion

    Based upon review of the data supporting the petitions, EPA has 
modified the proposed tolerances as follows: (1) Increased the 
tolerance level for Fruit, citrus, group 10 from 0.25 ppm to 0.35 ppm; 
for Citrus, dried pulp from 0.5 ppm to 1.8 ppm; and for Citrus, oil 
from 0.9 ppm to 4.0 ppm; and (2) Determined that a separate, higher 
tolerance of 0.4 ppm should be established for specific refined oils. 
EPA revised these tolerance levels based on analyses of the residue 
field trial data using the Agency's Tolerance Spreadsheet in accordance 
with the Agency's Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data and the results of citrus and oilseed processing 
studies. EPA also revised the commodity term for Safflower to read 
``Safflower, seed'' to agree with the recommended commodity term in the 
Office of Pesticide Program's Food and Feed Commodity Vocabulary.
    Therefore, tolerances are established for combined residues of 
zeta-cypermethrin, S-cyano(3-phenoxyphenyl)methyl()(cis-
trans 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate and 
its inactive R-isomers, in or on Borage, seed at 0.2 ppm; Castor oil 
plant, refined oil at 0.4 ppm; Castor oil plant, seed at 0.2 ppm; 
Chinese tallowtree, refined oil at 0.4 ppm; Chinese tallowtree, seed at 
0.2 ppm; Citrus, dried pulp at 1.8 ppm; Citrus, oil at 4.0 ppm; Crambe, 
seed at 0.2 ppm; Cuphea, seed at 0.2 ppm; Echium, seed at 0.2 ppm; 
Euphorbia, refined oil at 0.4 ppm; Euphorbia, seed at 0.2 ppm; Evening 
primrose, refined oil at 0.4 ppm; Evening primrose, seed at 0.2 ppm; 
Flax, seed at 0.2 ppm; Fruit, citrus, group 10 at 0.35 ppm; Gold of 
pleasure, seed at 0.2 ppm; Hare's-ear mustard, seed at 0.2 ppm; Jojoba, 
refined oil at 0.4 ppm; Jojoba, seed at 0.2 ppm; Lesquerella, seed at 
0.2 ppm; Lunaria, seed at 0.2 pm; Meadowfoam, seed at 0.2 ppm; 
Milkweed, seed at 0.2 ppm; Mustard, seed at 0.2 ppm; Niger seed, 
refined oil at 0.4 ppm; Niger seed, seed at 0.2 ppm; Oil radish, seed 
at 0.2 ppm; Okra at 0.2 ppm; Poppy, seed at 0.2 ppm; Rice, wild, grain 
at 1.5 ppm; Rose hip, refined oil at 0.4 ppm; Rose hip, seed at 0.2 
ppm; Safflower, seed at 0.2 ppm; Sesame, seed at 0.2 ppm; Stokes aster, 
refined oil at 0.4 ppm; Stokes aster, seed at 0.2 ppm; Sweet rocket, 
seed at 0.2 ppm; Tallowwood, refined oil at 0.4 ppm; Tallowwood, seed 
at 0.2 ppm; Tea oil plant, refined oil at 0.4 ppm; Tea oil plant, seed 
at 0.2 ppm; Vernonia, refined oil at 0.4 ppm; and Vernonia, seed at 0.2 
ppm.
    Time-limited tolerances were established at 40 CFR 180.418(b) for 
residues of zeta-cypermethrin in or on flax, meal and seed in 
connection with FIFRA section 18 emergency exemptions granted by EPA. 
These time-limited tolerances are no longer necessary, because a 
permanent tolerance is being established for flax at the same level. 
Therefore, these time-limited tolerances for residues of zeta-
cypermethrin are revoked.

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, 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) 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 6, 2000) do not apply to this rule. In addition, This 
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 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 20, 2007.
Lois Rossi
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 1525]]

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 the following 
commodities to the table in paragraph (a)(2) and removing the text from 
paragraph (b) and reserving the paragraph designation and heading to 
read as follows:


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

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Borage, seed............................................             0.2
                                * * * * *
Castor oil plant, refined oil...........................             0.4
Castor oil plant, seed..................................             0.2
                                * * * * *
Chinese tallowtree, refined oil.........................             0.4
Chinese tallowtree, seed................................             0.2
                                * * * * *
Citrus, dried pulp......................................             1.8
Citrus, oil.............................................             4.0
                                * * * * *
Crambe, seed............................................             0.2
Cuphea, seed............................................             0.2
Echium, seed............................................             0.2
                                * * * * *
Euphorbia, refined oil..................................             0.4
Euphorbia, seed.........................................             0.2
Evening primrose, refined oil...........................             0.4
Evening primrose, seed..................................             0.2
Flax, seed..............................................             0.2
                                * * * * *
Fruit, citrus, group 10.................................            0.35
                                * * * * *
Gold of pleasure, seed..................................             0.2
                                * * * * *
Hare's-ear mustard, seed................................             0.2
                                * * * * *
Jojoba, refined oil.....................................             0.4
Jojoba, seed............................................             0.2
Lesquerella, seed.......................................             0.2
Lunaria, seed...........................................             0.2
Meadowfoam, seed........................................             0.2
                                * * * * *
Milkweed, seed..........................................             0.2
Mustard, seed...........................................             0.2
Niger seed, refined oil.................................             0.4
Niger seed, seed........................................             0.2
                                * * * * *
Oil radish, seed........................................             0.2
Okra....................................................             0.2
                                * * * * *
Poppy, seed.............................................             0.2
                                * * * * *
Rice, wild, grain.......................................             1.5
Rose hip, refined oil...................................             0.4
Rose hip, seed..........................................             0.2
Safflower, seed.........................................             0.2
Sesame, seed............................................             0.2
                                * * * * *
Stokes aster, refined oil...............................             0.4
Stokes aster, seed......................................             0.2
                                * * * * *
Sweet rocket, seed......................................             0.2
Tallowwood, refined oil.................................             0.4
Tallowwood, seed........................................             0.2
Tea oil plant, refined oil..............................             0.4
Tea oil plant, seed.....................................             0.2
                                * * * * *
Vernonia, refined oil...................................             0.4
Vernonia, seed..........................................             0.2
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. E7-25392 Filed 1-8-08; 8:45 am]
BILLING CODE 6560-50-S