Prallethrin; Pesticide Tolerances, 64322-64330 [2014-25732]

Download as PDF 64322 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations rmajette on DSK2TPTVN1PROD with RULES 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). 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) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action 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, VerDate Sep<11>2014 13:58 Oct 28, 2014 Jkt 235001 Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: October 16, 2014. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.205: a. In the table for paragraph (a), remove the entries for ‘‘Ginger’’ and ‘‘Potato’’ and add alphabetically the entry ‘‘Vegetable, tuberous and corm, subgroup 1C’’; ■ b. In the table for paragraph (c), remove the entries for and ‘‘Cassava,’’ ‘‘Tanier,’’ and ‘‘Yam, true, tuber’’. The addition reads as follows: ■ ■ § 180.205 Paraquat; tolerances for residues. (a) * * * Parts per million Commodity * * * Vegetable, tuberous and corn, subgroup 1C ............ * * * * * * * * * 0.50 * * * [FR Doc. 2014–25592 Filed 10–28–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0659; FRL–9917–30] Prallethrin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of the insecticide prallethrin, including its metabolites and degradates, in or on all food commodities from use of prallethrin in food handling establishments where food and food products are held, processed, prepared and/or served, or as a wide-area mosquito adulticide at 1.0 part per million (ppm). McLaughlin Gormley King Company requested these tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA). SUMMARY: PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 This regulation is effective October 29, 2014. Objections and requests for hearings must be received on or before December 29, 2014, 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: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2013–0659, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Daniel J. Rosenblatt, Registration Division (RD) (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: DATES: 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. E:\FR\FM\29OCR1.SGM 29OCR1 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations C. How can I file an objection or hearing request? Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2013–0659 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 29, 2014. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2013–0659, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/ dockets. CFR 180.545 be amended by establishing a tolerance of 1.0 ppm for residues of the insecticide prallethrin, including its metabolites and degradates, in or on all raw agricultural commodities and processed food, and food products in food handling establishments where food and food products are held, processed, prepared and/or served, or as a wide-area mosquito adulticide. That document referenced a summary of the petition prepared by McLaughlin Gormley King Company, the registrant, which is available in the docket, http:// www.regulations.gov. There were no comments received in response to the notice of filing. rmajette on DSK2TPTVN1PROD with RULES II. Summary of Petitioned-For Tolerance III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for prallethrin including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with prallethrin follows. In the Federal Register of October 25, 2013 (78 FR 63938) (FRL–9901–96), EPA issued a document pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8090) by McLaughlin Gormley King Company, 8810 Tenth Avenue, Minneapolis, MN 55427. The petition requested that 40 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 VerDate Sep<11>2014 13:58 Oct 28, 2014 Jkt 235001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 64323 subgroups of consumers, including infants and children. Prallethrin is a member of the pyrethroid class of insecticides. Pyrethroids have historically been classified into two groups, Type I and Type II, based upon chemical structure and neurotoxicological effect. Type I pyrethroids lack an alpha-cyano moiety and induce a syndrome consisting of aggressive sparring, altered sensitivity to external stimuli, and fine tremor progressing to whole-body tremor and prostration in rats. These Type I pyrethroid-specific behaviors are collectively described as the Tsyndrome. Type II pyrethroids contain an alpha-cyano moiety and produce a syndrome that includes pawing, burrowing, salivation, and coarse tremors leading to choreoathetosis in rats. These Type II pyrethroid-specific behaviors are collectively described as the CS-syndrome (Verschoyle and Aldridge 1980; Lawrence and Casida 1982). Prallethrin is structurally similar to Type I pyrethroids. The adverse outcome pathway (AOP) shared by pyrethroids involves the ability to interact with voltage-gated sodium channels (VGSCs) in the central and peripheral nervous system, leading to changes in neuron firing, and ultimately neurotoxicity. Prallethrin has been evaluated for a variety of toxic effects in experimental toxicity studies. Neurotoxicity was observed throughout the database and is the most sensitive endpoint. Effects were seen across species, sexes, and routes of administration. In the acute rat neurotoxicity study, decreased exploratory behavior was seen at the time of peak effect. Reduced motor activity and transient tremors were also observed in the study. In the subchronic rat neurotoxicity study, a higher arousal rate was observed in animals at the highest dose tested. Clinical signs of neurotoxicity were also observed in other toxicity studies (subchronic and chronic oral studies in dogs, developmental toxicity studies in the rat and rabbit, 21-day dermal and 28-day inhalation studies in rats). No neurotoxic effects were observed in rats in the chronic toxicity study. Effects were also observed in the liver (rats, mice, and dogs), heart (dogs), and thyroid gland (rats). Some effects were also seen in the kidney (mice and rats). However, neurotoxicity was the most sensitive endpoint in the toxicology database, and other effects were generally seen in the presence of neurotoxicity and/or at higher doses. Liver effects observed included increased weight, elevated serum cholesterol and alkaline phosphatase E:\FR\FM\29OCR1.SGM 29OCR1 rmajette on DSK2TPTVN1PROD with RULES 64324 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations activity, centrilobular hepatocyte vacuolation, histiocytic infiltration, enlarged liver, and perilobular hepatocellular hypertrophy. In dogs, myocardial fiber degeneration was seen in females in the subchronic study at the highest dose tested. Heart effects were also seen in one mid-dose female in the chronic study (hemorrhage and red discoloration). However, there was no dose response for the observed heart lesions in the study. Thyroid effects were observed in rats and consisted of increases in the number of small follicles and follicular cell hypertrophy and hyperplasia. The thyroid effects were seen in short-term studies in the presence of liver effects. Kidney effects observed were increased weights and histopathology. Developmental and reproduction studies are available for prallethrin. There was no evidence of increased quantitative or qualitative susceptibility in any of the studies. In the developmental studies, no toxic effects were noted in fetuses up to the highest doses tested. Maternal effects in the studies included tremors, salivation, exaggerated reflexes, and chromorhinorrhea. In the reproduction study, decreased pup body weights were seen during the lactation period. Effects seen in parental animals were decreased body weights and body weight gains, increased liver weights and microscopic findings in the liver, kidney, thyroid, and pituitary. Prallethrin is classified as ‘‘Not Likely to be Carcinogenic to Humans.’’ No tumors were observed in rat and mouse carcinogenicity studies up to the highest doses tested. In both the rat and mouse studies, the animals could have tolerated higher dose levels; however, EPA determined that dose levels were adequate to assess potential carcinogenicity. Prallethrin tested negative in the majority of the genotoxicity studies. It also tested negative in an in vitro chromosomal aberration study in Chinese Hamster Ovary (CHO K1) cells without metabolic activation, but tested positive at all doses with metabolic activation. However, clastogenicity was not clearly dose-related, was seen at nontoxic and slightly toxic doses, and was not expressed in in vivo studies and structure-activity comparisons with the other pyrethroids revealed no correlations with clastogenicity. Other gene mutation, chromosomal aberration, and unscheduled DNA synthesis (UDS) VerDate Sep<11>2014 13:58 Oct 28, 2014 Jkt 235001 studies were negative; therefore, there is no concern for genotoxicity. Acute lethality studies conducted with prallethrin indicate moderate acute toxicity via the oral and inhalation routes of administration (Category II) and low acute toxicity via the dermal route (Categories IV). It is not irritating to the skin (Category IV) but is minimally irritating to the eye (Category IV). It is not a dermal sensitizer. The weight of evidence from the available guideline, non-guideline, mechanism of action, and pharmacokinetics studies supports characterizing the toxicological profile of pyrethroids, including prallethrin, as being rapid in onset and associated with acute, peak exposures. Also, there is no apparent increase in hazard from repeated/chronic exposures to prallethrin. Specific information on the studies received and the nature of the adverse effects caused by prallethrin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect level (LOAEL) from the toxicity studies can be found in the document titled ‘‘Prallethrin: Human Health Risk Assessment for the Tolerance Petition to Amend the Section 3 Mosquito Adulticide Registration to Include Use of the Insecticide Over All Crops,’’ dated September 15, 2014, by going to http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES. Locate and click on the hyperlink for docket ID number EPA–HQ–OPP– 2013–0659. Double-click on the document to view the referenced information. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for prallethrin used for human risk assessment are shown in Tables 1 and 2 of this unit. Based on the proposed use patterns for prallethrin, endpoints and points of departure were selected for dietary (acute only), dermal, inhalation, and incidental oral exposures. For oral exposures (acute dietary and incidental oral), the endpoint and POD were selected from a chronic dog study in which neurotoxicity was observed within 4 weeks of dosing and was considered to have potentially resulted from a single dose, based on a weightof-the-evidence. For dermal assessment, the endpoint was selected from the route-specific 21-day dermal study in the rat, in which clinical signs were observed within 1 to 3 days of dosing. The endpoints being used to assess oral and dermal exposures are the same (neurotoxicity); therefore, risks from those routes of exposure were combined. Although the LOAEL for inhalation is also based on neurotoxicity, derivation of the human equivalent concentrations (HECs) used for inhalation risk assessment shows that assessing inhalation exposure based on the portal-of-entry effects is protective of the systemic endpoints, including neurotoxicity. As a result, inhalation exposure was not combined with either the dermal or the oral routes of exposure. A chronic dietary risk assessment was not conducted for prallethrin. Given what is known about pyrethroid toxicokinetics/dynamics, in general, and as there is no apparent increase in hazard from repeated/chronic exposures to prallethrin, the acute dietary exposure assessment is protective of chronic dietary exposures. Based on the toxicity profile, intermediate- or longterm exposure assessments were not conducted for adults or children. E:\FR\FM\29OCR1.SGM 29OCR1 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations 64325 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PRALLETHRIN FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS Exposure/scenario Acute Dietary (Children ≥6 years old and Adults). Acute Dietary (Children <6 years old). Incidental Oral Short-Term (1 to 30 days). Dermal Short-term (1 to 30 days) (Children <6 years old). Dermal Short-term (1 to 30 days) (Children ≥6 years old and Adults). Inhalation Short-term (1 to 30 days) (Children <6 years old). Inhalation Short-term (1 to 30 days) (Children ≥6 years old and Adults). Point of departure and uncertainty/ FQPA safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects NOAEL = 2.5 mg/kg/ day. UFA = 10× UFH = 10× FQPA SF = 1× NOAEL = 2.5 mg/kg/ day. UFA = 10× UFH = 10× FQPA SF = 3× NOAEL = 2.5 mg/kg/ day. UFA = 10× UFH = 10× FQPA SF = 3× Dermal NOAEL = 30 mg/kg/day. UFA = 10× UFH = 10× FQPA SF = 3× Dermal NOAEL = 30 mg/kg/day. UFA = 10× UFH = 10× FQPA SF = 1× Inhalation NOAEL = 0.001 mg/L. UFA = 3× UFH = 10× FQPA SF = 3× HEC/HED calculations used for risk assessment (see below) Inhalation NOAEL = 0.001 mg/L. UFA = 3× UFH = 10× FQPA SF = 1× HEC/HED calculations used for risk assessment Acute RfD = 0.025 mg/kg/day. aPAD= 0.025 mg/kg/ day. Chronic dog study (capsule). LOAEL = 5 mg/kg/day based on clinical signs of neurotoxicity. Acute RfD = 0.025 mg/kg/day. aPAD= 0.008 mg/kg/ day Residential LOC for MOE = 300. Residential LOC for MOE = 300. 21-day Dermal Rat. LOAEL = 150 mg/kg/day based on observed clinical signs of toxicity (fixation, abnormal gait, tremors, sensitivity to external stimuli, vocalization, twitching and writhing spasms), all beginning between days 1 and 3 of a 21-day dermal study in rats. Residential LOC for MOE = 100. Residential LOC for MOE = 100. 28-Day Inhalation Rat. LOAEL = 0.0044 mg/L based on irregular respiration, decreased spontaneous activity, salivation, incontinence, and nasal discharge. Residential LOC for MOE = 30. aPAD = acute population adjusted dose. FQPA SF = FQPA Safety Factor. HEC = human equivalent concentration. HED = human equivalent dose. LOAEL = lowest observed adverse effect level. LOC = level of concern. MOE = margin of exposure. NOAEL = no observed adverse effect level. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PRALLETHRIN FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS Residential Residential HECs and HEDs .... rmajette on DSK2TPTVN1PROD with RULES Residential LOC for MOE = 100 (Children <6 years old). Residential LOC for MOE = 30 (Children ≥6 years old and Adults). VerDate Sep<11>2014 13:58 Oct 28, 2014 HECs Handler/Outdoor Post-application. Indoor Post-application without air ventilation. Indoor Post-application with air ventilation. Bystander ................ 0.00020 mg/L .......... 0.006 mg/kg/day. 0.00014 mg/L .......... N/A. Adults: 0.00004 mg/L Children: 0.00003 mg/L. 0.00002 mg/L .......... N/A. Jkt 235001 PO 00000 Frm 00029 Fmt 4700 HEDs N/A. Sfmt 4700 E:\FR\FM\29OCR1.SGM 29OCR1 64326 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations TABLE 2—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PRALLETHRIN FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS—Continued Residential Cancer (Oral, dermal, inhalation). HECs HEDs Classification: ‘‘Not Likely to be Carcinogenic to Humans.’’ HEC = human equivalent concentration. HED = human equivalent dose. Kg = kilogram. LOC = level of concern. L = Liter. Mg = milligram. MOE = margin of exposure. N/A = Not applicable. rmajette on DSK2TPTVN1PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prallethrin, EPA considered exposure under the petitioned-for tolerances as well as all existing prallethrin tolerances in 40 CFR 180.545. Acute and chronic aggregate dietary (food and drinking water) exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM– FCID) Version 3.16. This software uses 2003–2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). i. Acute exposure. The acute dietary risk assessment is partially refined, and is based on the assumption that as a result of potential use in food handling establishments (FHEs), most commodities will have residues at onehalf the limit of quantification (LOQ) of the analytical method used in the FHE residue trials (0.05 ppm). It was also based on the assumptions that all flour food forms will contain residues at the highest level found in the FHE residue trials on flour, and that tree nuts and peanuts will contain residues at the highest level found in the FHE residue trials on peanuts. Based on residue data, the highest residue value (0.0045 ppm) was used for all crops as a result of treatment from the mosquito adulticide use. The percent FHE value of 4.65% was applied to the FHE residue values, and the adulticide residues were incorporated at a level of 100% (i.e., all foods could potentially have residues resulting from the mosquito adulticide use). Residues from food handling (modified by the % FHE estimate) and mosquito adulticide treatments were combined. ii. Chronic exposure. A chronic dietary risk assessment was not conducted. However, a chronic exposure assessment was conducted to determine background levels of dietary exposure for estimating aggregate risk. The exposure estimates are based on the highest residue value from the FHE VerDate Sep<11>2014 13:58 Oct 28, 2014 Jkt 235001 residue trials for tree nuts, peanuts, and all flour food forms; and on the LOQ of the method used in the FHE trials (0.10 ppm). The data were treated in the same manner as the data in the acute dietary risk assessment, with the exception that the average residue value from the adulticide trials (0.0007 ppm) was used instead of the highest residue value (0.0045 ppm). For the chronic exposure assessment, EPA applied a percent FHE value of 4.65% to the FHE residue values and assumed 100 percent crop treated (PCT) for the proposed mosquito adulticide use, just as we have done for the acute exposure assessment. This value is considered to be an overestimate of the potential for the mosquito adulticide to drift onto growing crops. Residues from the FHE and adulticide uses were then combined. Processing factors were not used because the assumption was made that foods in an FHE could be treated after processing. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that prallethrin does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(F) of FFDCA states that EPA to 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 the 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 section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6–7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%. The Agency estimates a maximum 4.65% probability that a food a person consumes contains residues as a result of treatment in an FHE at some point with any pesticide (i.e., it is not specific to prallethrin). This value was derived by taking into account the daily probability of treatment and the percent of expenditures resulting in potential residues in restaurants, commercial kitchens, food warehouses, and food processors. For both the acute and chronic assessments, this value was used for the FHE component of the residue for all commodities with the exception of drinking water. The Agency believes that the three conditions discussed in Unit III.C.1.iv. 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 E:\FR\FM\29OCR1.SGM 29OCR1 rmajette on DSK2TPTVN1PROD with RULES Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations 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 reliable information on the regional consumption of food to which prallethrin may be applied in a particular area. Specific information on the methodology to estimate PCT can be found in the document entitled ‘‘Prallethrin: Upper Bound Estimate of the Likelihood of Insecticide Residues on Food Resulting from Treatment in Food Handling Establishments,’’ dated September 7, 2014, by going to http:// www.regulations.gov. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prallethrin. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prallethrin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/ water/index.htm. Based on the First Index Reservoir Screening Tool (FIRST), Tier II Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), and the Pesticide Flooded Application Model (PFAM), the surface water estimated drinking water concentration (EDWC) value of 0.591 parts per billion (ppb) was used in the acute assessment and that the annual average surface water EDWC value of 0.0375 ppb was used in the chronic assessment. 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). Prallethrin is currently registered for the following uses that could result in residential exposures: A variety of residential pet, indoor and outdoor uses for pests found on turf, and in homes and commercial settings, including food handling establishments. However, for purposes of this assessment, only registered residential products and use sites with the highest application rates or percent active ingredient (a.i.) were assessed because they are representative VerDate Sep<11>2014 13:58 Oct 28, 2014 Jkt 235001 of the worst case exposure scenarios for the exposed populations. EPA assessed potential residential handler exposure scenarios resulting from mixing/loading/applying sprays to lawns using hose-end and backpack sprayers because exposure from treating lawns were higher than from other application methods and sites. A quantitative assessment was not required for handling of total release fogger products since the labels state that the room/house must be vacated immediately by the user once initiated. EPA assessed post-application dermal exposure for adults and children as well as incidental oral (i.e., hand-to-mouth) exposure for children resulting from contact with residues deposited on turf and indoor surfaces following application with aerial and truckmounted fogger mosquito vector control applications, hand-held spray applications on turf and lawn, and indoor aerosol foggers, respectively. Adult and child post-application inhalation exposure resulting from both aerial and truck-mounted mosquito vector control applications were also assessed. A quantitative postapplication inhalation exposure assessment was not performed for turf or indoor aerosol foggers because inhalation exposure from these application methods is anticipated to be negligible. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http:// www.epa.gov/pesticides/trac/science/ trac6a05.pdf. 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.’’ The Agency has determined that the pyrethroids and pyrethrins share a common mechanism of toxicity (go to http://www.regulations.gov and search under document ID number EPA–HQ– OPP–2008–0489–0006). The members of this group share the ability to interact with voltage-gated sodium channels ultimately leading to neurotoxicity. The cumulative risk assessment for the pyrethroids/pyrethrins was published on November 9, 2011, and is available at http://www.regulations.gov under EPA–HQ–OPP–2011–0746. No cumulative risks of concern were identified, allowing the Agency to consider new uses for pyrethroids. For PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 64327 information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity, and to evaluate the cumulative effects of this class of chemicals, see EPA’s Web site at http://www.epa.gov/oppsrrd1/ reevaluation/pyrethroidspyrethrins.html. Prallethrin is included in the pyrethroids/pyrethrins cumulative risk assessment. No dietary, residential or aggregate risk estimates of concern have been identified in the single chemical assessment. In the cumulative assessment, residential exposure was the greatest contributor to the total exposure. An existing residential turf use for prallethrin was evaluated to determine the potential contribution it would have on the cumulative risk assessment. Although the turf use was considered the main contributor for residential exposure, the turf assessment indicated that exposure from turf would not impact the residential component of the cumulative risk estimates for the pyrethroids. Therefore, since the proposed mosquito adulticide contributes far less exposure than the registered turf uses, there will be no impact on the residential component of the cumulative risk estimates. Dietary exposures make a minor contribution to the total pyrethroid exposure. The dietary exposure assessment performed in support of the pyrethroid cumulative was much more highly refined than that performed for prallethrin. In addition, for the prallethrin risk assessment, the most sensitive apical endpoint in the prallethrin database was selected to derive the POD. Further, the POD selected for prallethrin is specific to prallethrin, whereas the POD selected for the cumulative assessment was based on common mechanism of action data that are appropriate for all 20 pyrethroids included in the cumulative assessment. Dietary exposure to prallethrin residues resulting from the proposed mosquito adulticide use over all crops will contribute very little to the dietary exposure to prallethrin alone; therefore, the proposed use will make an insignificant contribution to dietary risk to the pyrethroids as a whole. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10x) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines, E:\FR\FM\29OCR1.SGM 29OCR1 rmajette on DSK2TPTVN1PROD with RULES 64328 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations 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 Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10x, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The prallethrin toxicity database includes developmental toxicity studies in the rat and rabbit, and a reproduction study in the rat. No evidence of increased qualitative or quantitative susceptibility was noted in any of these studies. This lack of susceptibility is consistent with the results of guideline developmental and reproduction studies with other pyrethroid pesticides. High-dose studies assessing what dose results in lethality to 50% of the tested population (LD50) in the scientific literature indicate that pyrethroid exposure can result in increased quantitative sensitivity in the young, specifically in the form of neurotoxicity. Examination of pharmacokinetic and pharmacodynamic data indicates that the sensitivity observed at high doses is related to pyrethroid age-dependent pharmacokinetics, which is the activity of enzymes associated with the metabolism of pyrethroids. With otherwise equivalent administered doses for adults and juveniles, predictive pharmacokinetic models indicate that the differential adultjuvenile pharmacokinetics will result in a 3x greater dose at the target organ in juveniles compared to adults. No evidence of increased quantitative or qualitative susceptibility was seen in the pyrethroid scientific literature related to pharmacodynamics (the effect of pyrethroids at the target tissue) both with regard to interspecies differences between rats and humans and to differences between juveniles and adults. Specifically, there are in vitro pharmacodynamic data and in vivo data indicating similar responses between adult and juvenile rats at low doses and data indicating that the rat is a conservative model compared to the human based on species-specific pharmacodynamics of homologous sodium channel isoforms in rats and humans. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 3x for infants and children less than 6 years of age. For the general population, including children greater than 6 years of age, EPA is VerDate Sep<11>2014 13:58 Oct 28, 2014 Jkt 235001 reducing the FQPA SF to 1x. These decisions are based on the following findings: i. The toxicology database for prallethrin is considered complete with respect to guideline toxicity studies for prallethrin; however, the Agency lacks additional information to fully characterize the potential for juvenile sensitivity to the neurotoxic effects of pyrethroids. In light of the literature studies indicating a possibility of increased sensitivity in juvenile rats at high doses, EPA identified a need, and requested proposals for, additional nonguideline studies to evaluate the potential for sensitivity in juvenile rats. A group of pyrethroid registrants is currently conducting those studies. Pending the results of those studies, however, the available toxicity studies for prallethrin can be used to characterize toxic effects including potential developmental and reproductive toxicity, as well as neurotoxicity. Acceptable developmental toxicity studies in rats and rabbits, reproduction studies in rats, neurotoxicity studies (acute, subchronic, and developmental) in rats are available. In addition, route-specific dermal and inhalation toxicity studies are available. The Immunotoxicity study has been waived. As discussed in Unit IV.D.2., EPA concludes that the 3x FQPA SF will be adequate for protecting infants and children less than 6 years old. ii. After reviewing the extensive body of data and peer-reviewed literature on pyrethroids, the Agency has reached a number of conclusions regarding fetal and juvenile sensitivity for pyrethroids, including the following: • Based on an evaluation of over 70 guideline toxicity studies for 24 pyrethroids submitted to the Agency, including prenatal developmental toxicity studies in rats and rabbits, and pre- and postnatal multi-generation reproduction toxicity studies and DNTs in rats in support of pyrethroid registrations, there is no evidence that pyrethroids directly impact developing fetuses. None of the studies show any indications of fetal toxicity at doses that do not cause maternal toxicity. • Increased susceptibility was seen in offspring animals in the DNT study with the pyrethroid zeta-cypermethrin (decreased pup body weights) and DNT and reproduction studies with another pyrethroid beta-cyfluthrin (decreased body weights and tremors). However, the reductions in body weight and the other non-specific effects occur at higher doses than neurotoxicity, the effect of concern for pyrethroids. The available developmental and PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 reproduction guideline studies in rats with zeta-cypermethrin did not show increased sensitivity in the young to neurotoxic effects. Overall, findings of increased sensitivity in juvenile animals in pyrethroid studies are rare. Therefore, the residual concern for the postnatal effects is reduced. • High-dose LD50 studies (studies assessing what dose results in lethality to 50% of the tested population) in the scientific literature indicate that pyrethroids can result in increased quantitative sensitivity to juvenile animals. Examination of pharmacokinetic and pharmacodynamic data indicates that the sensitivity observed at high doses is related to pyrethroid age-dependent pharmacokinetics—the activity of enzymes associated with the metabolism of pyrethroids. Furthermore, a rat physiologically-based pharmacokinetic (PBPK) model predicts a 3-fold increase of pyrethroid concentration in juvenile brain compared to adults at high doses. • In vitro pharmacodynamic data and in vivo data indicate that adult and juvenile rats have similar responses to pyrethroids at low doses and therefore juvenile sensitivity is not expected at relevant environmental exposures. Further, data also show that the rat is a conservative model compared to the human based on species-specific pharmacodynamics of homologous sodium channel isoforms. iii. There are no residual uncertainties with regard to dietary exposure. The dietary exposure assessments are based on highly conservative residue levels for the mosquito adulticide use and for the FHE uses. Furthermore, conservative, upper-bound assumptions were used to determine exposure through drinking water and residential sources, such that these exposures have not been underestimated. Taking all of this information into account, EPA has reduced the FQPA SF for women of child-bearing age because there is no evidence in the over 70 guideline toxicity studies submitted to the Agency that pyrethroids directly impact developing fetuses. In addition, none of the studies show any indications of fetal toxicity at doses that do not cause maternal toxicity. Because there remains some uncertainty as to juvenile sensitivity due to the findings in the high-dose LD50 studies, EPA is retaining a 3x FQPA SF for infants and children less than 6 years of age. By age 6, the metabolic system is expected to be at or near adult levels thus reducing concerns for potential age-dependent sensitivity related to pharmacokinetics; therefore for children over 6, a 1x factor E:\FR\FM\29OCR1.SGM 29OCR1 rmajette on DSK2TPTVN1PROD with RULES Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations is appropriate. Although EPA is seeking additional data to further characterize the potential neurotoxicity for pyrethroids, EPA has reliable data that show that reducing the FQPA SF to 3x will protect the safety of infants and children less than 6 years old. These data include: a. Data from developmental and reproductive toxicity guideline studies with prallethrin that show no sensitivity. b. Data showing that the potential sensitivity at high doses is likely due to pharmacokinetics. c. A rat PBPK model predicting a 3fold increase of pyrethroid concentration in the juvenile brain compared to adults at high doses due to age-dependent pharmacokinetics. d. Data indicating that the rat is a conservative model compared to the human based on species-specific pharmacodynamics of homologous sodium channel isoforms. iv. Although EPA has required additional data on transferable residues from treated turf for prallethrin, EPA is confident that it has not underestimated turf exposure due to the conservativeness of the default turf transfer value and conservative assumptions in the short-term turf assessment procedures (e.g., assuming residues do not degrade over the thirty day assessment period and assuming high-end activities on turf for every day of the assessment period). The additional data on turf transferable residues have been required in case requirement of exposure assessments is needed on the future, and to further EPA’s general understanding of the availability of pesticide residues on turf. For several reasons, EPA has determined that reliable data show that a 3x factor is protective of the safety of infants and children less than 6 years of age. First, it is likely that the extensive guideline studies with pyrethroids, which indicate that increased sensitivity in juvenile animals in pyrethroid studies is rare, better characterize the potential sensitivity of juvenile animals than the LD50 studies. The high doses that produced juvenile sensitivity in the literature studies are well above normal dietary or residential exposure levels of pyrethroids to juveniles and lower levels of exposure anticipated from dietary and residential uses are not expected to overwhelm the juvenile’s ability to metabolize pyrethroids, as occurred with the high doses used in the literature studies. The fact that a greater sensitivity to the neurotoxicity of pyrethroids is not found in guideline studies following in utero exposures (based on more than 70 studies for 24 VerDate Sep<11>2014 13:58 Oct 28, 2014 Jkt 235001 pyrethroids) supports this conclusion, despite the relatively high doses used in the studies. Second, in vitro data indicate similar pharmacodynamic response to pyrethroids between juvenile and adult rats. Finally, as indicated, pharmacokinetic modeling only predicts a 3x difference between juveniles and adults. Therefore, the FQPA SF of 3x is protective of potential juvenile sensitivity. Specific information about the reevaluation of the FQPA SF for pyrethroids may be found in document ID number EPA–HQ–OPP–2011–0746– 0011. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Acute aggregate risk from exposure to prallethrin results from exposure to residues in food and drinking water alone. The acute dietary exposure analysis included both food and drinking water; therefore, acute aggregate risk estimates are equivalent to the acute dietary risk estimates. The acute risk estimate for the general U.S. population is 10% of the aPAD. The population subgroup with the highest acute dietary risk estimate is children 1– 2, which uses 76% of the aPAD. Acute aggregate risk is not of concern for the general U.S. population or any other population subgroup. 2. Chronic risk. Using the exposure assumptions described in this unit, there is no increase in hazard with increasing dose duration; therefore, the acute aggregate assessment is protective of potential chronic aggregate exposures. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The short-term aggregate risk assessments resulted in MOEs of 620 for children, and 1,600 for adult females and the general U.S. PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 64329 population. The adult and children’s MOEs are greater than their respective LOCs of 100 and 300. As a result, the short-term aggregate risk estimates are not of concern for the general U.S. population or any population subgroup. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, prallethrin is not expected to pose an intermediate-term risk. 5. Aggregate cancer risk for U.S. population. Based on the data summarized in Units III.A. and III.C.1.iii., EPA has concluded that prallethrin is not expected to pose a cancer risk to humans. 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 prallethrin residues. IV. Other Considerations A. Analytical Enforcement Methodology A method based on gas chromatography with electron capture detection (GC/ECD), ID #262, is adequate for the enforcement of tolerances for residues of prallethrin in or on crop commodities. The reported limits of quantitation (LOQs) are 0.01 to 0.10 ppm, depending on the commodity. The limits of detection (LODs) were reported to be 0.004 to 0.06 ppm, depending on the commodity. Multiresidue methods testing for prallethrin have not been conducted, and is not required, based on previous Agency discussions with the petitioner on November 3, 2010. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by section 408(b)(4) of FFDCA. The Codex Alimentarius is a joint E:\FR\FM\29OCR1.SGM 29OCR1 64330 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, section 408(b)(4) of FFDCA requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for prallethrin. rmajette on DSK2TPTVN1PROD with RULES V. Conclusion Therefore, tolerances are established for residues of the insecticide prallethrin, including its metabolites and degradates, in or on all raw agricultural commodities and processed food from use of prallethrin in food handling establishments where food and food products are held, processed, prepared and/or served, or as a widearea mosquito adulticide at 1.0 part per million (ppm). Compliance with the tolerance level specified is to be determined by measuring only prallethrin, 2-methyl-4-oxo-3-(2-propyn1-yl)-2-cyclopenten-1-yl-2,2-dimethyl-3(2-methyl-1-propen-1yl)cyclopropanecarboxylate. EPA is revising 40 CFR 180.545 to clarify the tolerance. EPA is merging paragraphs (a)(1) and (2) together into a new paragraph (a). EPA is removing paragraphs (a)(3) and (4) as they contain language that is more appropriately regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as use directions on the label. VI. Statutory and Executive Order Reviews This action establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under VerDate Sep<11>2014 13:58 Oct 28, 2014 Jkt 235001 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 action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). 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) (15 U.S.C. 272 note). and pests, Reporting and recordkeeping requirements. Dated: October 17, 2014. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. ■ 2. Revise § 180.545 to read as follows: § 180.545 Prallethrin; tolerances for residues. (a) General. Tolerances are established for residues of the insecticide prallethrin, including its metabolites and degradates, in or on all raw agricultural commodities and processed food from use of prallethrin in food handling establishments where food and food products are held, processed, prepared and/or served, or as a wide-area mosquito adulticide at 1.0 part per million (ppm). Compliance with the tolerance level specified is to be determined by measuring only prallethrin, 2-methyl-4-oxo-3-(2-propyn1-yl)-2-cyclopenten-1-yl-2,2-dimethyl-3(2-methyl-1-propen-1yl)cyclopropanecarboxylate. (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 2014–25732 Filed 10–28–14; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 VII. Congressional Review Act [Docket No. 140822715–4882–02] Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). RIN 0648–BE37 List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Tilefish Fishery; 2015–2017 Specifications National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. AGENCY: NMFS issues final specifications for the commercial SUMMARY: E:\FR\FM\29OCR1.SGM 29OCR1

Agencies

[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Rules and Regulations]
[Pages 64322-64330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25732]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0659; FRL-9917-30]


Prallethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide prallethrin, including its metabolites and degradates, in 
or on all food commodities from use of prallethrin in food handling 
establishments where food and food products are held, processed, 
prepared and/or served, or as a wide-area mosquito adulticide at 1.0 
part per million (ppm). McLaughlin Gormley King Company requested these 
tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 29, 2014. Objections and 
requests for hearings must be received on or before December 29, 2014, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0659, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel J. Rosenblatt, Registration 
Division (RD) (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-7090; email address: 
RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

[[Page 64323]]

C. How can I file an objection or hearing request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0659 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 29, 2014. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0659, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 25, 2013 (78 FR 63938) (FRL-
9901-96), EPA issued a document pursuant to section 408(d)(3) of FFDCA, 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F8090) by McLaughlin Gormley King Company, 8810 Tenth Avenue, 
Minneapolis, MN 55427. The petition requested that 40 CFR 180.545 be 
amended by establishing a tolerance of 1.0 ppm for residues of the 
insecticide prallethrin, including its metabolites and degradates, in 
or on all raw agricultural commodities and processed food, and food 
products in food handling establishments where food and food products 
are held, processed, prepared and/or served, or as a wide-area mosquito 
adulticide. That document referenced a summary of the petition prepared 
by McLaughlin Gormley King Company, the registrant, which is available 
in the docket, http://www.regulations.gov. There were no comments 
received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for prallethrin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with prallethrin 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Prallethrin is a member of the pyrethroid class of insecticides. 
Pyrethroids have historically been classified into two groups, Type I 
and Type II, based upon chemical structure and neurotoxicological 
effect. Type I pyrethroids lack an alpha-cyano moiety and induce a 
syndrome consisting of aggressive sparring, altered sensitivity to 
external stimuli, and fine tremor progressing to whole-body tremor and 
prostration in rats. These Type I pyrethroid-specific behaviors are 
collectively described as the T-syndrome. Type II pyrethroids contain 
an alpha-cyano moiety and produce a syndrome that includes pawing, 
burrowing, salivation, and coarse tremors leading to choreoathetosis in 
rats. These Type II pyrethroid-specific behaviors are collectively 
described as the CS-syndrome (Verschoyle and Aldridge 1980; Lawrence 
and Casida 1982). Prallethrin is structurally similar to Type I 
pyrethroids. The adverse outcome pathway (AOP) shared by pyrethroids 
involves the ability to interact with voltage-gated sodium channels 
(VGSCs) in the central and peripheral nervous system, leading to 
changes in neuron firing, and ultimately neurotoxicity.
    Prallethrin has been evaluated for a variety of toxic effects in 
experimental toxicity studies. Neurotoxicity was observed throughout 
the database and is the most sensitive endpoint. Effects were seen 
across species, sexes, and routes of administration. In the acute rat 
neurotoxicity study, decreased exploratory behavior was seen at the 
time of peak effect. Reduced motor activity and transient tremors were 
also observed in the study. In the subchronic rat neurotoxicity study, 
a higher arousal rate was observed in animals at the highest dose 
tested. Clinical signs of neurotoxicity were also observed in other 
toxicity studies (subchronic and chronic oral studies in dogs, 
developmental toxicity studies in the rat and rabbit, 21-day dermal and 
28-day inhalation studies in rats). No neurotoxic effects were observed 
in rats in the chronic toxicity study.
    Effects were also observed in the liver (rats, mice, and dogs), 
heart (dogs), and thyroid gland (rats). Some effects were also seen in 
the kidney (mice and rats). However, neurotoxicity was the most 
sensitive endpoint in the toxicology database, and other effects were 
generally seen in the presence of neurotoxicity and/or at higher doses. 
Liver effects observed included increased weight, elevated serum 
cholesterol and alkaline phosphatase

[[Page 64324]]

activity, centrilobular hepatocyte vacuolation, histiocytic 
infiltration, enlarged liver, and perilobular hepatocellular 
hypertrophy. In dogs, myocardial fiber degeneration was seen in females 
in the subchronic study at the highest dose tested. Heart effects were 
also seen in one mid-dose female in the chronic study (hemorrhage and 
red discoloration). However, there was no dose response for the 
observed heart lesions in the study. Thyroid effects were observed in 
rats and consisted of increases in the number of small follicles and 
follicular cell hypertrophy and hyperplasia. The thyroid effects were 
seen in short-term studies in the presence of liver effects. Kidney 
effects observed were increased weights and histopathology.
    Developmental and reproduction studies are available for 
prallethrin. There was no evidence of increased quantitative or 
qualitative susceptibility in any of the studies. In the developmental 
studies, no toxic effects were noted in fetuses up to the highest doses 
tested. Maternal effects in the studies included tremors, salivation, 
exaggerated reflexes, and chromorhinorrhea. In the reproduction study, 
decreased pup body weights were seen during the lactation period. 
Effects seen in parental animals were decreased body weights and body 
weight gains, increased liver weights and microscopic findings in the 
liver, kidney, thyroid, and pituitary.
    Prallethrin is classified as ``Not Likely to be Carcinogenic to 
Humans.'' No tumors were observed in rat and mouse carcinogenicity 
studies up to the highest doses tested. In both the rat and mouse 
studies, the animals could have tolerated higher dose levels; however, 
EPA determined that dose levels were adequate to assess potential 
carcinogenicity.
    Prallethrin tested negative in the majority of the genotoxicity 
studies. It also tested negative in an in vitro chromosomal aberration 
study in Chinese Hamster Ovary (CHO K1) cells without metabolic 
activation, but tested positive at all doses with metabolic activation. 
However, clastogenicity was not clearly dose-related, was seen at 
nontoxic and slightly toxic doses, and was not expressed in in vivo 
studies and structure-activity comparisons with the other pyrethroids 
revealed no correlations with clastogenicity. Other gene mutation, 
chromosomal aberration, and unscheduled DNA synthesis (UDS) studies 
were negative; therefore, there is no concern for genotoxicity.
    Acute lethality studies conducted with prallethrin indicate 
moderate acute toxicity via the oral and inhalation routes of 
administration (Category II) and low acute toxicity via the dermal 
route (Categories IV). It is not irritating to the skin (Category IV) 
but is minimally irritating to the eye (Category IV). It is not a 
dermal sensitizer. The weight of evidence from the available guideline, 
non-guideline, mechanism of action, and pharmacokinetics studies 
supports characterizing the toxicological profile of pyrethroids, 
including prallethrin, as being rapid in onset and associated with 
acute, peak exposures. Also, there is no apparent increase in hazard 
from repeated/chronic exposures to prallethrin.
    Specific information on the studies received and the nature of the 
adverse effects caused by prallethrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect 
level (LOAEL) from the toxicity studies can be found in the document 
titled ``Prallethrin: Human Health Risk Assessment for the Tolerance 
Petition to Amend the Section 3 Mosquito Adulticide Registration to 
Include Use of the Insecticide Over All Crops,'' dated September 15, 
2014, by going to http://www.regulations.gov. The referenced document 
is available in the docket established by this action, which is 
described under ADDRESSES. Locate and click on the hyperlink for docket 
ID number EPA-HQ-OPP- 2013-0659. Double-click on the document to view 
the referenced information.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects are identified (the 
LOAEL). Uncertainty/safety factors are used in conjunction with the POD 
to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for prallethrin used for 
human risk assessment are shown in Tables 1 and 2 of this unit. Based 
on the proposed use patterns for prallethrin, endpoints and points of 
departure were selected for dietary (acute only), dermal, inhalation, 
and incidental oral exposures.
    For oral exposures (acute dietary and incidental oral), the 
endpoint and POD were selected from a chronic dog study in which 
neurotoxicity was observed within 4 weeks of dosing and was considered 
to have potentially resulted from a single dose, based on a weight-of-
the-evidence. For dermal assessment, the endpoint was selected from the 
route-specific 21-day dermal study in the rat, in which clinical signs 
were observed within 1 to 3 days of dosing. The endpoints being used to 
assess oral and dermal exposures are the same (neurotoxicity); 
therefore, risks from those routes of exposure were combined. Although 
the LOAEL for inhalation is also based on neurotoxicity, derivation of 
the human equivalent concentrations (HECs) used for inhalation risk 
assessment shows that assessing inhalation exposure based on the 
portal-of-entry effects is protective of the systemic endpoints, 
including neurotoxicity. As a result, inhalation exposure was not 
combined with either the dermal or the oral routes of exposure.
    A chronic dietary risk assessment was not conducted for 
prallethrin. Given what is known about pyrethroid toxicokinetics/
dynamics, in general, and as there is no apparent increase in hazard 
from repeated/chronic exposures to prallethrin, the acute dietary 
exposure assessment is protective of chronic dietary exposures. Based 
on the toxicity profile, intermediate- or long-term exposure 
assessments were not conducted for adults or children.

[[Page 64325]]



  Table 1--Summary of Toxicological Doses and Endpoints for Prallethrin for Use in Dietary and Non-Occupational
                                          Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario          and uncertainty/FQPA   RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Children >=6 years  NOAEL = 2.5 mg/kg/    Acute RfD = 0.025    Chronic dog study (capsule). LOAEL
 old and Adults).                   day.                  mg/kg/day.           = 5 mg/kg/day based on clinical
                                   UFA = 10x...........  aPAD= 0.025 mg/kg/    signs of neurotoxicity.
                                   UFH = 10x...........   day..
                                   FQPA SF = 1x........
Acute Dietary (Children <6 years   NOAEL = 2.5 mg/kg/    Acute RfD = 0.025
 old).                              day.                  mg/kg/day.
                                   UFA = 10x...........  aPAD= 0.008 mg/kg/
                                   UFH = 10x...........   day.
                                   FQPA SF = 3x........
Incidental Oral Short-Term (1 to   NOAEL = 2.5 mg/kg/    Residential LOC for
 30 days).                          day.                  MOE = 300.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 3x........
Dermal Short-term (1 to 30 days)   Dermal NOAEL = 30 mg/ Residential LOC for  21-day Dermal Rat. LOAEL = 150 mg/
 (Children <6 years old).           kg/day.               MOE = 300.           kg/day based on observed clinical
                                   UFA = 10x...........                        signs of toxicity (fixation,
                                   UFH = 10x...........                        abnormal gait, tremors,
                                   FQPA SF = 3x........                        sensitivity to external stimuli,
                                                                               vocalization, twitching and
                                                                               writhing spasms), all beginning
                                                                               between days 1 and 3 of a 21-day
                                                                               dermal study in rats.
Dermal Short-term (1 to 30 days)   Dermal NOAEL = 30 mg/ Residential LOC for
 (Children >=6 years old and        kg/day.               MOE = 100.
 Adults).                          UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
Inhalation Short-term (1 to 30     Inhalation NOAEL =    Residential LOC for  28-Day Inhalation Rat. LOAEL =
 days) (Children <6 years old).     0.001 mg/L.           MOE = 100.           0.0044 mg/L based on irregular
                                   UFA = 3x............                        respiration, decreased
                                   UFH = 10x...........                        spontaneous activity, salivation,
                                   FQPA SF = 3x........                        incontinence, and nasal
                                   HEC/HED calculations                        discharge.
                                    used for risk
                                    assessment (see
                                    below).
Inhalation Short-term (1 to 30     Inhalation NOAEL =    Residential LOC for
 days) (Children >=6 years old      0.001 mg/L.           MOE = 30.
 and Adults).                      UFA = 3x............
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                   HEC/HED calculations
                                    used for risk
                                    assessment.
----------------------------------------------------------------------------------------------------------------
aPAD = acute population adjusted dose. FQPA SF = FQPA Safety Factor. HEC = human equivalent concentration. HED =
  human equivalent dose. LOAEL = lowest observed adverse effect level. LOC = level of concern. MOE = margin of
  exposure. NOAEL = no observed adverse effect level. Point of Departure (POD) = A data point or an estimated
  point that is derived from observed dose-response data and used to mark the beginning of extrapolation to
  determine risk associated with lower environmentally relevant human exposures. RfD = reference dose. UF =
  uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
  sensitivity among members of the human population (intraspecies).


  Table 2--Summary of Toxicological Doses and Endpoints for Prallethrin for Use in Dietary and Non-Occupational
                                          Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                        Residential              HECs                        HEDs
----------------------------------------------------------------------------------------------------------------
Residential HECs and HEDs........  Handler/Outdoor Post- 0.00020 mg/L.......  0.006 mg/kg/day.
                                    application.
Residential LOC for MOE = 100      Indoor Post-          0.00014 mg/L.......  N/A.
 (Children <6 years old).           application without
                                    air ventilation.
Residential LOC for MOE = 30       Indoor Post-          Adults: 0.00004 mg/  N/A.
 (Children >=6 years old and        application with      L.
 Adults).                           air ventilation.     Children: 0.00003
                                                          mg/L..
                                   Bystander...........  0.00002 mg/L.......  N/A.
                                  ------------------------------------------------------------------------------

[[Page 64326]]

 
Cancer (Oral, dermal, inhalation)           Classification: ``Not Likely to be Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
HEC = human equivalent concentration. HED = human equivalent dose. Kg = kilogram. LOC = level of concern. L =
  Liter. Mg = milligram. MOE = margin of exposure. N/A = Not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to prallethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing prallethrin tolerances in 40 CFR 
180.545. Acute and chronic aggregate dietary (food and drinking water) 
exposure assessments were conducted using the Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption 
data from the U.S. Department of Agriculture's (USDA's) National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA).
    i. Acute exposure. The acute dietary risk assessment is partially 
refined, and is based on the assumption that as a result of potential 
use in food handling establishments (FHEs), most commodities will have 
residues at one-half the limit of quantification (LOQ) of the 
analytical method used in the FHE residue trials (0.05 ppm). It was 
also based on the assumptions that all flour food forms will contain 
residues at the highest level found in the FHE residue trials on flour, 
and that tree nuts and peanuts will contain residues at the highest 
level found in the FHE residue trials on peanuts. Based on residue 
data, the highest residue value (0.0045 ppm) was used for all crops as 
a result of treatment from the mosquito adulticide use.
    The percent FHE value of 4.65% was applied to the FHE residue 
values, and the adulticide residues were incorporated at a level of 
100% (i.e., all foods could potentially have residues resulting from 
the mosquito adulticide use). Residues from food handling (modified by 
the % FHE estimate) and mosquito adulticide treatments were combined.
    ii. Chronic exposure. A chronic dietary risk assessment was not 
conducted. However, a chronic exposure assessment was conducted to 
determine background levels of dietary exposure for estimating 
aggregate risk. The exposure estimates are based on the highest residue 
value from the FHE residue trials for tree nuts, peanuts, and all flour 
food forms; and on the LOQ of the method used in the FHE trials (0.10 
ppm). The data were treated in the same manner as the data in the acute 
dietary risk assessment, with the exception that the average residue 
value from the adulticide trials (0.0007 ppm) was used instead of the 
highest residue value (0.0045 ppm).
    For the chronic exposure assessment, EPA applied a percent FHE 
value of 4.65% to the FHE residue values and assumed 100 percent crop 
treated (PCT) for the proposed mosquito adulticide use, just as we have 
done for the acute exposure assessment. This value is considered to be 
an overestimate of the potential for the mosquito adulticide to drift 
onto growing crops. Residues from the FHE and adulticide uses were then 
combined. Processing factors were not used because the assumption was 
made that foods in an FHE could be treated after processing.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that prallethrin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(F) of FFDCA states that EPA to 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 the 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 section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency estimates a maximum 4.65% probability that a food a 
person consumes contains residues as a result of treatment in an FHE at 
some point with any pesticide (i.e., it is not specific to 
prallethrin). This value was derived by taking into account the daily 
probability of treatment and the percent of expenditures resulting in 
potential residues in restaurants, commercial kitchens, food 
warehouses, and food processors. For both the acute and chronic 
assessments, this value was used for the FHE component of the residue 
for all commodities with the exception of drinking water.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. 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

[[Page 64327]]

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 reliable information on the 
regional consumption of food to which prallethrin may be applied in a 
particular area.
    Specific information on the methodology to estimate PCT can be 
found in the document entitled ``Prallethrin: Upper Bound Estimate of 
the Likelihood of Insecticide Residues on Food Resulting from Treatment 
in Food Handling Establishments,'' dated September 7, 2014, by going to 
http://www.regulations.gov.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for prallethrin. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
prallethrin. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), Tier II 
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), and the Pesticide Flooded Application Model (PFAM), the surface 
water estimated drinking water concentration (EDWC) value of 0.591 
parts per billion (ppb) was used in the acute assessment and that the 
annual average surface water EDWC value of 0.0375 ppb was used in the 
chronic assessment.
    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).
    Prallethrin is currently registered for the following uses that 
could result in residential exposures: A variety of residential pet, 
indoor and outdoor uses for pests found on turf, and in homes and 
commercial settings, including food handling establishments. However, 
for purposes of this assessment, only registered residential products 
and use sites with the highest application rates or percent active 
ingredient (a.i.) were assessed because they are representative of the 
worst case exposure scenarios for the exposed populations.
    EPA assessed potential residential handler exposure scenarios 
resulting from mixing/loading/applying sprays to lawns using hose-end 
and backpack sprayers because exposure from treating lawns were higher 
than from other application methods and sites. A quantitative 
assessment was not required for handling of total release fogger 
products since the labels state that the room/house must be vacated 
immediately by the user once initiated.
    EPA assessed post-application dermal exposure for adults and 
children as well as incidental oral (i.e., hand-to-mouth) exposure for 
children resulting from contact with residues deposited on turf and 
indoor surfaces following application with aerial and truck-mounted 
fogger mosquito vector control applications, hand-held spray 
applications on turf and lawn, and indoor aerosol foggers, 
respectively. Adult and child post-application inhalation exposure 
resulting from both aerial and truck-mounted mosquito vector control 
applications were also assessed. A quantitative post-application 
inhalation exposure assessment was not performed for turf or indoor 
aerosol foggers because inhalation exposure from these application 
methods is anticipated to be negligible. Further information regarding 
EPA standard assumptions and generic inputs for residential exposures 
may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.''
    The Agency has determined that the pyrethroids and pyrethrins share 
a common mechanism of toxicity (go to http://www.regulations.gov and 
search under document ID number EPA-HQ-OPP-2008-0489-0006). The members 
of this group share the ability to interact with voltage-gated sodium 
channels ultimately leading to neurotoxicity. The cumulative risk 
assessment for the pyrethroids/pyrethrins was published on November 9, 
2011, and is available at http://www.regulations.gov under EPA-HQ-OPP-
2011-0746. No cumulative risks of concern were identified, allowing the 
Agency to consider new uses for pyrethroids. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity, and to evaluate the cumulative effects of this class of 
chemicals, see EPA's Web site at http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.
    Prallethrin is included in the pyrethroids/pyrethrins cumulative 
risk assessment. No dietary, residential or aggregate risk estimates of 
concern have been identified in the single chemical assessment. In the 
cumulative assessment, residential exposure was the greatest 
contributor to the total exposure. An existing residential turf use for 
prallethrin was evaluated to determine the potential contribution it 
would have on the cumulative risk assessment. Although the turf use was 
considered the main contributor for residential exposure, the turf 
assessment indicated that exposure from turf would not impact the 
residential component of the cumulative risk estimates for the 
pyrethroids.
    Therefore, since the proposed mosquito adulticide contributes far 
less exposure than the registered turf uses, there will be no impact on 
the residential component of the cumulative risk estimates.
    Dietary exposures make a minor contribution to the total pyrethroid 
exposure. The dietary exposure assessment performed in support of the 
pyrethroid cumulative was much more highly refined than that performed 
for prallethrin. In addition, for the prallethrin risk assessment, the 
most sensitive apical endpoint in the prallethrin database was selected 
to derive the POD. Further, the POD selected for prallethrin is 
specific to prallethrin, whereas the POD selected for the cumulative 
assessment was based on common mechanism of action data that are 
appropriate for all 20 pyrethroids included in the cumulative 
assessment. Dietary exposure to prallethrin residues resulting from the 
proposed mosquito adulticide use over all crops will contribute very 
little to the dietary exposure to prallethrin alone; therefore, the 
proposed use will make an insignificant contribution to dietary risk to 
the pyrethroids as a whole.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines,

[[Page 64328]]

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 Food Quality Protection Act Safety Factor (FQPA SF). 
In applying this provision, EPA either retains the default value of 
10x, or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prallethrin toxicity 
database includes developmental toxicity studies in the rat and rabbit, 
and a reproduction study in the rat. No evidence of increased 
qualitative or quantitative susceptibility was noted in any of these 
studies. This lack of susceptibility is consistent with the results of 
guideline developmental and reproduction studies with other pyrethroid 
pesticides.
    High-dose studies assessing what dose results in lethality to 50% 
of the tested population (LD50) in the scientific literature 
indicate that pyrethroid exposure can result in increased quantitative 
sensitivity in the young, specifically in the form of neurotoxicity. 
Examination of pharmacokinetic and pharmacodynamic data indicates that 
the sensitivity observed at high doses is related to pyrethroid age-
dependent pharmacokinetics, which is the activity of enzymes associated 
with the metabolism of pyrethroids. With otherwise equivalent 
administered doses for adults and juveniles, predictive pharmacokinetic 
models indicate that the differential adult-juvenile pharmacokinetics 
will result in a 3x greater dose at the target organ in juveniles 
compared to adults. No evidence of increased quantitative or 
qualitative susceptibility was seen in the pyrethroid scientific 
literature related to pharmacodynamics (the effect of pyrethroids at 
the target tissue) both with regard to interspecies differences between 
rats and humans and to differences between juveniles and adults. 
Specifically, there are in vitro pharmacodynamic data and in vivo data 
indicating similar responses between adult and juvenile rats at low 
doses and data indicating that the rat is a conservative model compared 
to the human based on species-specific pharmacodynamics of homologous 
sodium channel isoforms in rats and humans.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 3x for infants and children less than 6 years 
of age. For the general population, including children greater than 6 
years of age, EPA is reducing the FQPA SF to 1x. These decisions are 
based on the following findings:
    i. The toxicology database for prallethrin is considered complete 
with respect to guideline toxicity studies for prallethrin; however, 
the Agency lacks additional information to fully characterize the 
potential for juvenile sensitivity to the neurotoxic effects of 
pyrethroids. In light of the literature studies indicating a 
possibility of increased sensitivity in juvenile rats at high doses, 
EPA identified a need, and requested proposals for, additional non-
guideline studies to evaluate the potential for sensitivity in juvenile 
rats. A group of pyrethroid registrants is currently conducting those 
studies. Pending the results of those studies, however, the available 
toxicity studies for prallethrin can be used to characterize toxic 
effects including potential developmental and reproductive toxicity, as 
well as neurotoxicity. Acceptable developmental toxicity studies in 
rats and rabbits, reproduction studies in rats, neurotoxicity studies 
(acute, subchronic, and developmental) in rats are available. In 
addition, route-specific dermal and inhalation toxicity studies are 
available. The Immunotoxicity study has been waived. As discussed in 
Unit IV.D.2., EPA concludes that the 3x FQPA SF will be adequate for 
protecting infants and children less than 6 years old.
    ii. After reviewing the extensive body of data and peer-reviewed 
literature on pyrethroids, the Agency has reached a number of 
conclusions regarding fetal and juvenile sensitivity for pyrethroids, 
including the following:
     Based on an evaluation of over 70 guideline toxicity 
studies for 24 pyrethroids submitted to the Agency, including prenatal 
developmental toxicity studies in rats and rabbits, and pre- and 
postnatal multi-generation reproduction toxicity studies and DNTs in 
rats in support of pyrethroid registrations, there is no evidence that 
pyrethroids directly impact developing fetuses. None of the studies 
show any indications of fetal toxicity at doses that do not cause 
maternal toxicity.
     Increased susceptibility was seen in offspring animals in 
the DNT study with the pyrethroid zeta-cypermethrin (decreased pup body 
weights) and DNT and reproduction studies with another pyrethroid beta-
cyfluthrin (decreased body weights and tremors). However, the 
reductions in body weight and the other non-specific effects occur at 
higher doses than neurotoxicity, the effect of concern for pyrethroids. 
The available developmental and reproduction guideline studies in rats 
with zeta-cypermethrin did not show increased sensitivity in the young 
to neurotoxic effects. Overall, findings of increased sensitivity in 
juvenile animals in pyrethroid studies are rare. Therefore, the 
residual concern for the postnatal effects is reduced.
     High-dose LD50 studies (studies assessing what 
dose results in lethality to 50% of the tested population) in the 
scientific literature indicate that pyrethroids can result in increased 
quantitative sensitivity to juvenile animals. Examination of 
pharmacokinetic and pharmacodynamic data indicates that the sensitivity 
observed at high doses is related to pyrethroid age-dependent 
pharmacokinetics--the activity of enzymes associated with the 
metabolism of pyrethroids. Furthermore, a rat physiologically-based 
pharmacokinetic (PBPK) model predicts a 3-fold increase of pyrethroid 
concentration in juvenile brain compared to adults at high doses.
     In vitro pharmacodynamic data and in vivo data indicate 
that adult and juvenile rats have similar responses to pyrethroids at 
low doses and therefore juvenile sensitivity is not expected at 
relevant environmental exposures. Further, data also show that the rat 
is a conservative model compared to the human based on species-specific 
pharmacodynamics of homologous sodium channel isoforms.
    iii. There are no residual uncertainties with regard to dietary 
exposure. The dietary exposure assessments are based on highly 
conservative residue levels for the mosquito adulticide use and for the 
FHE uses. Furthermore, conservative, upper-bound assumptions were used 
to determine exposure through drinking water and residential sources, 
such that these exposures have not been underestimated.
    Taking all of this information into account, EPA has reduced the 
FQPA SF for women of child-bearing age because there is no evidence in 
the over 70 guideline toxicity studies submitted to the Agency that 
pyrethroids directly impact developing fetuses. In addition, none of 
the studies show any indications of fetal toxicity at doses that do not 
cause maternal toxicity. Because there remains some uncertainty as to 
juvenile sensitivity due to the findings in the high-dose 
LD50 studies, EPA is retaining a 3x FQPA SF for infants and 
children less than 6 years of age. By age 6, the metabolic system is 
expected to be at or near adult levels thus reducing concerns for 
potential age-dependent sensitivity related to pharmacokinetics; 
therefore for children over 6, a 1x factor

[[Page 64329]]

is appropriate. Although EPA is seeking additional data to further 
characterize the potential neurotoxicity for pyrethroids, EPA has 
reliable data that show that reducing the FQPA SF to 3x will protect 
the safety of infants and children less than 6 years old. These data 
include:
    a. Data from developmental and reproductive toxicity guideline 
studies with prallethrin that show no sensitivity.
    b. Data showing that the potential sensitivity at high doses is 
likely due to pharmacokinetics.
    c. A rat PBPK model predicting a 3-fold increase of pyrethroid 
concentration in the juvenile brain compared to adults at high doses 
due to age-dependent pharmacokinetics.
    d. Data indicating that the rat is a conservative model compared to 
the human based on species-specific pharmacodynamics of homologous 
sodium channel isoforms.
    iv. Although EPA has required additional data on transferable 
residues from treated turf for prallethrin, EPA is confident that it 
has not underestimated turf exposure due to the conservativeness of the 
default turf transfer value and conservative assumptions in the short-
term turf assessment procedures (e.g., assuming residues do not degrade 
over the thirty day assessment period and assuming high-end activities 
on turf for every day of the assessment period). The additional data on 
turf transferable residues have been required in case requirement of 
exposure assessments is needed on the future, and to further EPA's 
general understanding of the availability of pesticide residues on 
turf.
    For several reasons, EPA has determined that reliable data show 
that a 3x factor is protective of the safety of infants and children 
less than 6 years of age. First, it is likely that the extensive 
guideline studies with pyrethroids, which indicate that increased 
sensitivity in juvenile animals in pyrethroid studies is rare, better 
characterize the potential sensitivity of juvenile animals than the 
LD50 studies. The high doses that produced juvenile 
sensitivity in the literature studies are well above normal dietary or 
residential exposure levels of pyrethroids to juveniles and lower 
levels of exposure anticipated from dietary and residential uses are 
not expected to overwhelm the juvenile's ability to metabolize 
pyrethroids, as occurred with the high doses used in the literature 
studies. The fact that a greater sensitivity to the neurotoxicity of 
pyrethroids is not found in guideline studies following in utero 
exposures (based on more than 70 studies for 24 pyrethroids) supports 
this conclusion, despite the relatively high doses used in the studies. 
Second, in vitro data indicate similar pharmacodynamic response to 
pyrethroids between juvenile and adult rats. Finally, as indicated, 
pharmacokinetic modeling only predicts a 3x difference between 
juveniles and adults. Therefore, the FQPA SF of 3x is protective of 
potential juvenile sensitivity.
    Specific information about the reevaluation of the FQPA SF for 
pyrethroids may be found in document ID number EPA-HQ-OPP-2011-0746-
0011.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Acute aggregate risk from exposure to prallethrin 
results from exposure to residues in food and drinking water alone. The 
acute dietary exposure analysis included both food and drinking water; 
therefore, acute aggregate risk estimates are equivalent to the acute 
dietary risk estimates. The acute risk estimate for the general U.S. 
population is 10% of the aPAD. The population subgroup with the highest 
acute dietary risk estimate is children 1-2, which uses 76% of the 
aPAD. Acute aggregate risk is not of concern for the general U.S. 
population or any other population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this 
unit, there is no increase in hazard with increasing dose duration; 
therefore, the acute aggregate assessment is protective of potential 
chronic aggregate exposures.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). The short-
term aggregate risk assessments resulted in MOEs of 620 for children, 
and 1,600 for adult females and the general U.S. population. The adult 
and children's MOEs are greater than their respective LOCs of 100 and 
300. As a result, the short-term aggregate risk estimates are not of 
concern for the general U.S. population or any population subgroup.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term adverse effect was identified, 
prallethrin is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the data 
summarized in Units III.A. and III.C.1.iii., EPA has concluded that 
prallethrin is not expected to pose a cancer risk to humans.
    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 prallethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A method based on gas chromatography with electron capture 
detection (GC/ECD), ID #262, is adequate for the enforcement of 
tolerances for residues of prallethrin in or on crop commodities. The 
reported limits of quantitation (LOQs) are 0.01 to 0.10 ppm, depending 
on the commodity. The limits of detection (LODs) were reported to be 
0.004 to 0.06 ppm, depending on the commodity. Multiresidue methods 
testing for prallethrin have not been conducted, and is not required, 
based on previous Agency discussions with the petitioner on November 3, 
2010.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by section 
408(b)(4) of FFDCA. The Codex Alimentarius is a joint

[[Page 64330]]

United Nations Food and Agriculture Organization/World Health 
Organization food standards program, and it is recognized as an 
international food safety standards-setting organization in trade 
agreements to which the United States is a party. EPA may establish a 
tolerance that is different from a Codex MRL; however, section 
408(b)(4) of FFDCA requires that EPA explain the reasons for departing 
from the Codex level. The Codex has not established a MRL for 
prallethrin.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide prallethrin, including its metabolites and degradates, in 
or on all raw agricultural commodities and processed food from use of 
prallethrin in food handling establishments where food and food 
products are held, processed, prepared and/or served, or as a wide-area 
mosquito adulticide at 1.0 part per million (ppm). Compliance with the 
tolerance level specified is to be determined by measuring only 
prallethrin, 2-methyl-4-oxo-3-(2-propyn-1-yl)-2-cyclopenten-1-yl-2,2-
dimethyl-3-(2-methyl-1-propen-1-yl)cyclopropanecarboxylate.
    EPA is revising 40 CFR 180.545 to clarify the tolerance. EPA is 
merging paragraphs (a)(1) and (2) together into a new paragraph (a). 
EPA is removing paragraphs (a)(3) and (4) as they contain language that 
is more appropriately regulated under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) as use directions on the label.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under section 408(d) of FFDCA in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: October 17, 2014.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. Revise Sec.  180.545 to read as follows:


Sec.  180.545  Prallethrin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide prallethrin, including its metabolites and degradates, in 
or on all raw agricultural commodities and processed food from use of 
prallethrin in food handling establishments where food and food 
products are held, processed, prepared and/or served, or as a wide-area 
mosquito adulticide at 1.0 part per million (ppm). Compliance with the 
tolerance level specified is to be determined by measuring only 
prallethrin, 2-methyl-4-oxo-3-(2-propyn-1-yl)-2-cyclopenten-1-yl-2,2-
dimethyl-3-(2-methyl-1-propen-1-yl)cyclopropanecarboxylate.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2014-25732 Filed 10-28-14; 8:45 am]
BILLING CODE 6560-50-P