Cyprodinil; Pesticide Tolerances, 47304-47309 [2016-17268]

Download as PDF Lhorne on DSK30JT082PROD with RULES 47304 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations in the Unfunded Mandates Reform Act of 1995 (Public Law 104–4); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 19, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time VerDate Sep<11>2014 14:56 Jul 20, 2016 Jkt 238001 within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today’s Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: June 24, 2016. Alexis Strauss, Acting Regional Administrator, Region IX. Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows: PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. Subpart F—California 2. Section 52.220 is amended by adding paragraphs (c)(39)(ii)(J) and (c)(39)(iv)(J) to read as follows: ■ § 52.220 Identification of plan—in part. * * * * * (c) * * * (39) * * * (ii) * * * (J) Previously approved on November 9, 1978 in paragraph (c)(39)(ii)(B) of this section and now deleted without replacement: Rules 213, 213.1, and 213.2. * * * * * (iv) * * * (J) Previously approved on November 9, 1978 in paragraph (c)(39)(iv)(B) of this section and now deleted without replacement: Rules 213, 213.1, and 213.2. * * * * * [FR Doc. 2016–17171 Filed 7–20–16; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0646; FRL–9948–28] Cyprodinil; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of cyprodinil in or on vegetable, tuberous and corm, subgroup 1C and potato, wet peel. Syngenta Crop Protection, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective July 21, 2016. Objections and requests for hearings must be received on or before September 19, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2015–0646, 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: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: 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 E:\FR\FM\21JYR1.SGM 21JYR1 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations 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. Lhorne on DSK30JT082PROD with RULES C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2015–0646 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 September 19, 2016. 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– 2015–0646, 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. VerDate Sep<11>2014 14:56 Jul 20, 2016 Jkt 238001 • 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.html. 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 21, 2015 (80 FR 63731) (FRL–9935–29), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F8358) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419– 8300. The petition requested that 40 CFR 180.532 be amended by establishing tolerances for residues of the fungicide cyprodinil, 4-cyclopropyl6-methyl-N-phenyl-2-pyrimidinamine, in or on vegetable, tuberous and corm, subgroup 1C at 0.01 parts per million (ppm) and potato, wet peel at 0.03 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http:// www.regulations.gov. No comments were 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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 47305 support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for cyprodinil including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with cyprodinil 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. The major target organs of cyprodinil are the liver and the kidney. Liver effects were consistent among male and female rats and mice in both subchronic and chronic studies and typically included increased liver weights along with increases in serum clinical chemistry parameters associated with adverse effects on liver function (i.e., increased cholesterol and phospholipid levels). Microscopic lesions in rats and mice included hepatocyte hypertrophy and hepatocellular necrosis. In the kidneys, adverse effects were seen as chronic tubular lesions and chronic kidney inflammation following sub-chronic exposure of male rats. Chronically, cyprodinil caused increased kidney weights and progressive nephropathy in male rats. Chronic effects in dogs were limited to decreased body-weight gain, decreased food consumption and decreased food efficiency; liver toxicity was not seen in the dog. Although increases in thyroid weight and/or hypertrophy of thyroid follicular cells were observed at higher doses in the rat 28-day oral-toxicity studies and in the 90-day oral-toxicity study in rats, treatment related changes in thyroid weights or gross/microscopic observations were not observed in the chronic rat study or in other studies. A 28-day dietary immunotoxicity study in mice resulted in no apparent suppression of the humoral component of the immune system. The only effect attributed to cyprodinil treatment was higher mean absolute, relative (to body weight), and adjusted liver weights for the 5,000 ppm group. There were no treatment-related effects on absolute, adjusted, or relative spleen or thymus weights; no effects on specific activity or total activity of splenic Immunoglobulin M antibody-forming cells to the T cell-dependent red blood cell antigens. No dermal or systemic E:\FR\FM\21JYR1.SGM 21JYR1 Lhorne on DSK30JT082PROD with RULES 47306 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations toxicity was seen following repeated dermal application at the highest dose in a 21-day dermal toxicity study in rabbits. An acute neurotoxicity study indicated systemic toxicity with signs of induced hunched posture, piloerection, and reduced responsiveness to sensory stimuli and reduced motor activity. Females were slightly more affected than males per daily clinical observations, which disappeared by day 3 to 4. A dose-related reduction in body temperature was seen in all treated animals, thus hypothermia is considered a compound-related effect in the highest dose tested and was found to be statistically significant, whereas the lower dosed animals was not or only marginally significant and was fully reversible in all groups. Clinical signs, hypothermia, and changes in motor activity were found to all be reversible by day 8. There were no histopathological findings to support evidence of damage to the central nervous system, eyes, optic nerves, or skeletal muscles. A sub-chronic neurotoxicity study showed no treatment related effects on mortality, clinical signs, or gross or histological neuropathology. Functional observational battery and motor activity testing revealed no treatment related effects up to the highest dose tested. There was no evidence of increased susceptibility in the developmental rat or rabbit study following in utero exposure or in the two-generation reproduction study following pre- and post-natal exposure. Fetal toxicity, manifested as significantly lower fetal weights and an increased incidence of delayed ossification in the rat and a slight increase in litters showing extra ribs (13th) in the rabbit, was reported in developmental toxicity studies. In a rat two-generation reproduction study, significantly lower pup weights for F 1 and F 2 offspring were observed. However, each of these fetal/neonatal effects occurred at the same dose levels at which maternal toxicity (decreased body weight gain) was observed and were considered to be secondary to maternal toxicity. Based on the lack of evidence of carcinogenicity in mice and rats at doses that were judged to be adequate to the carcinogenic potential, cyprodinil was classified as ‘‘not likely to be carcinogenic to humans.’’ Specific information on the studies received and the nature of the adverse effects caused by cyprodinil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// VerDate Sep<11>2014 14:56 Jul 20, 2016 Jkt 238001 www.regulations.gov in document, ‘‘Human Health Risk Assessment for Registration Review and New Use Risk Assessment to Support the Registration of Proposed Use on Crop Subgroup 1C’’ in docket ID number EPA–HQ–OPP– 2015–0646. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. 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 cyprodinil used for human risk assessment is discussed in Unit III.B of the final rule published in the Federal Register of August 17, 2012 (77 FR 49732) (FRL–9359–7). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cyprodinil, EPA considered exposure under the petitioned-for tolerances as well as all existing cyprodinil tolerances in 40 CFR 180.532. i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for cyprodinil. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA utilized the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM–FCID, Version 3.16 default processing factors and tolerance-level residues and 100 percent crop treated (PCT) for all commodities. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA dietary survey conducted from 2003 to 2008. As to residue levels in food, EPA tolerance-level residues were used for most commodities, and average field trial residues were used for pome fruit, head lettuce, leaf lettuce, spinach, tomato, and grapes. 100 PCT assumptions were used for all commodities. DEEM default and empirical processing factors were used to modify the tolerance values. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that cyprodinil 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)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. 2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for cyprodinil and CGA 249287 in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyprodinil and CGA 249287. 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. E:\FR\FM\21JYR1.SGM 21JYR1 Lhorne on DSK30JT082PROD with RULES Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), Screening Concentration in Ground Water (SCI– GROW) models and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of cyprodinil and CGA 249287 for acute exposures are estimated to be 34.8 parts per billion (ppb) for surface water and 2.05 ppb for ground water. EDWCs for chronic exposures for noncancer assessments are estimated to be 24.7 ppb for surface water and 1.80 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 34.8 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 24.7 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Cyprodinil is currently registered for the following uses that could result in residential exposures: Ornamental plants. EPA assessed residential exposure using the following assumptions: Only short-term inhalation exposures to adult residential handlers from application to ornamental plants. Though there may be short-term dermal exposures to handlers, this was not assessed since no dermal endpoint was identified. Post-application exposures to adults and children are not expected. Intermediate or chronic exposures are not expected. 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.’’ EPA has not found cyprodinil to share a common mechanism of toxicity with any other substances, and cyprodinil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this VerDate Sep<11>2014 14:56 Jul 20, 2016 Jkt 238001 tolerance action, therefore, EPA has assumed that cyprodinil does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the 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. In a rat developmental toxicity study, there were significantly lower mean fetal weights in the high-dose group compared to controls as well as a significant increase in skeletal anomalies in the high-dose group due to abnormal ossification. The skeletal anomalies/variations were considered to be a transient developmental delay that occurs secondary to the maternal toxicity noted in the high-dose group. In the rabbit study, the only treatment related developmental effect was indication of an increased incidence of a 13th rib at maternally toxic doses. Signs of fetal effects in the twogeneration reproductive toxicity study included significantly lower F1 and F2 pup weights in the high-dose group during lactation, which continued to be lower than controls post-weaning and after the pre-mating period in the F1 generation only. Reproductive effects were seen only at doses that also caused parental toxicity. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for non-inhalation routes of exposure and retained at 10X for inhalation exposure scenarios for all population groups. That decision is based on the following findings: i. The toxicity database for cyprodinil is complete, except for a 90-day PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 47307 inhalation toxicity study required to reduce uncertainty associated with the use of an oral POD for assessing risk via the inhalation route. In the absence of a route-specific inhalation study, a 10x FQPA SF factor for residential scenarios will be retained for risk assessments involving inhalation exposure. ii. As indicated by an acute neurotoxicity study in mice, clinical signs, hypothermia, and changes in motor activity were all found to be reversible and no longer seen at day 8. There were no treatment related effects on mortality, gross or histological neuropathology. Reduced motor activity, induced hunched posture, piloerection and reduced responsiveness to sensory stimuli were observed and disappeared in all animals by day 3 to 4. In a sub-chronic neurotoxicity study in rats, there were no treatment related effects on mortality, clinical signs, or gross or histological neuropathology. No clinical signs suggestive of neurobehavioral alterations or evidence of neuropathological effects were observed in the available oral-toxicity studies. Based on this evidence, there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity. iii. In the prenatal developmental rat and rabbit studies and in the twogeneration reproduction rat study, toxicity to the fetuses/offspring, when observed, occurred at the same doses at which effects were observed in maternal/parental animals. All of these fetal effects were considered to be secondary to maternal toxicity. There is no evidence that cyprodinil results in increased susceptibility in utero rats or rabbits in the prenatal developmental studies or in young rats in the twogeneration reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The acute dietary assessment was conservative and based on 100 PCT and tolerance level residues as well as DEEM default and empirical processing factors. The chronic dietary assessment was partially refined with average field trial residues for some commodities and tolerance-level residues for the remaining commodities. DEEM default and empirical processing factors were also incorporated into the chronic dietary assessment. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyprodinil in drinking water. Based on the discussion in Unit III.C.3, postapplication exposure of children as well as incidental oral exposure of toddlers is not expected. These assessments will not E:\FR\FM\21JYR1.SGM 21JYR1 47308 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations Lhorne on DSK30JT082PROD with RULES underestimate the exposure and risks posed by cyprodinil. 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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cyprodinil will occupy 8.6% of the aPAD for children one to two years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyprodinil from food and water will utilize 86% of the cPAD for children one to two years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of cyprodinil is not expected. 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). Cyprodinil is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to cyprodinil. Using the exposure assumptions described in this unit for short-term exposures, EPA has estimated the short-term food, water, and residential exposures. For adults, oral dietary and inhalation estimates were combined using the total aggregate risk index (ARI) methodology since the levels of concern (LOC) for oral and dietary exposure (LOC = 100) and inhalation (LOC 1,000) are different. The short-term ARI for adults is 70 which is greater than 1 and is therefore, not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic VerDate Sep<11>2014 14:56 Jul 20, 2016 Jkt 238001 exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, cyprodinil is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediateterm residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for cyprodinil. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, chemical name 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 cyprodinil residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (AG–631 and AG–631B) are available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; 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 FFDCA section 408(b)(4). The Codex Alimentarius is a joint 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 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for cyprodinil in/on potato, wet peel and vegetable, tuberous and corm, subgroup 1C. V. Conclusion Therefore, tolerances are established for residues of cyprodinil, 4cyclopropyl-6-methyl-N-phenyl-2pyrimidinamin, in or on potato, wet peel at 0.03 and vegetable, tuberous and corm, subgroup 1C at 0.01ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) 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 action has been exempted from review under Executive Order 12866, this action 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 action 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 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 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 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 E:\FR\FM\21JYR1.SGM 21JYR1 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (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 (NTTAA) (15 U.S.C. 272 note). 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: July 11, 2016. Daniel Kenny, 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 § 180.532, add alphabetically the commodities ‘‘Potato, wet peel’’ and ‘‘Vegetable, tuberous and corm, subgroup 1C’’ to the table in paragraph (a) to read as follows: Lhorne on DSK30JT082PROD with RULES § 180.532 Cyprodinil; tolerances for residues. (a) General. (1) * * * VerDate Sep<11>2014 14:56 Jul 20, 2016 Jkt 238001 * * * * Vegetable, tuberous and corm, subgroup 1C ........................... * * * * * * * [FR Doc. 2016–17268 Filed 7–20–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2014–0329; FRL–9945–41] Isaria fumosorosea Strain FE 9901; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: VII. Congressional Review Act ■ * * * * Potato, wet peel .......................... * 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 0.03 information about the docket available at http://www.epa.gov/dockets. * FOR FURTHER INFORMATION CONTACT: 0.01 Robert McNally, Biopesticides and Pollution Prevention Division (7511P), * Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: BPPDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: Parts per million Commodity * This regulation establishes an exemption from the requirement of a tolerance for residues of Isaria fumosorosea strain FE 9901 in or on all food commodities when used in accordance with label directions and good agricultural practices. Novozymes BioAg, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Isaria fumosorosea strain FE 9901 under FFDCA. SUMMARY: This regulation is effective July 21, 2016. Objections and requests for hearings must be received on or before September 19, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0329, 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 ADDRESSES: PO 00000 Frm 00025 Fmt 4700 47309 Sfmt 4700 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 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. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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–2014–0329 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 September 19, 2016. Addresses for mail and hand delivery of objections E:\FR\FM\21JYR1.SGM 21JYR1

Agencies

[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Rules and Regulations]
[Pages 47304-47309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17268]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0646; FRL-9948-28]


Cyprodinil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyprodinil in or on vegetable, tuberous and corm, subgroup 1C and 
potato, wet peel. Syngenta Crop Protection, LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 21, 2016. Objections and 
requests for hearings must be received on or before September 19, 2016, 
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-2015-0646, 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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

[[Page 47305]]

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.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0646 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 
September 19, 2016. 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-2015-0646, 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.html.
    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 21, 2015 (80 FR 63731) (FRL-
9935-29), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5F8358) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR 180.532 be amended by 
establishing tolerances for residues of the fungicide cyprodinil, 4-
cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on vegetable, 
tuberous and corm, subgroup 1C at 0.01 parts per million (ppm) and 
potato, wet peel at 0.03 ppm. That document referenced a summary of the 
petition prepared by Syngenta Crop Protection, LLC, the registrant, 
which is available in the docket, http://www.regulations.gov. No 
comments were 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for cyprodinil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with cyprodinil 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.
    The major target organs of cyprodinil are the liver and the kidney. 
Liver effects were consistent among male and female rats and mice in 
both sub-chronic and chronic studies and typically included increased 
liver weights along with increases in serum clinical chemistry 
parameters associated with adverse effects on liver function (i.e., 
increased cholesterol and phospholipid levels). Microscopic lesions in 
rats and mice included hepatocyte hypertrophy and hepatocellular 
necrosis. In the kidneys, adverse effects were seen as chronic tubular 
lesions and chronic kidney inflammation following sub-chronic exposure 
of male rats. Chronically, cyprodinil caused increased kidney weights 
and progressive nephropathy in male rats. Chronic effects in dogs were 
limited to decreased body-weight gain, decreased food consumption and 
decreased food efficiency; liver toxicity was not seen in the dog. 
Although increases in thyroid weight and/or hypertrophy of thyroid 
follicular cells were observed at higher doses in the rat 28-day oral-
toxicity studies and in the 90-day oral-toxicity study in rats, 
treatment related changes in thyroid weights or gross/microscopic 
observations were not observed in the chronic rat study or in other 
studies.
    A 28-day dietary immunotoxicity study in mice resulted in no 
apparent suppression of the humoral component of the immune system. The 
only effect attributed to cyprodinil treatment was higher mean 
absolute, relative (to body weight), and adjusted liver weights for the 
5,000 ppm group. There were no treatment-related effects on absolute, 
adjusted, or relative spleen or thymus weights; no effects on specific 
activity or total activity of splenic Immunoglobulin M antibody-forming 
cells to the T cell-dependent red blood cell antigens. No dermal or 
systemic

[[Page 47306]]

toxicity was seen following repeated dermal application at the highest 
dose in a 21-day dermal toxicity study in rabbits.
    An acute neurotoxicity study indicated systemic toxicity with signs 
of induced hunched posture, piloerection, and reduced responsiveness to 
sensory stimuli and reduced motor activity. Females were slightly more 
affected than males per daily clinical observations, which disappeared 
by day 3 to 4. A dose-related reduction in body temperature was seen in 
all treated animals, thus hypothermia is considered a compound-related 
effect in the highest dose tested and was found to be statistically 
significant, whereas the lower dosed animals was not or only marginally 
significant and was fully reversible in all groups. Clinical signs, 
hypothermia, and changes in motor activity were found to all be 
reversible by day 8. There were no histopathological findings to 
support evidence of damage to the central nervous system, eyes, optic 
nerves, or skeletal muscles. A sub-chronic neurotoxicity study showed 
no treatment related effects on mortality, clinical signs, or gross or 
histological neuropathology. Functional observational battery and motor 
activity testing revealed no treatment related effects up to the 
highest dose tested.
    There was no evidence of increased susceptibility in the 
developmental rat or rabbit study following in utero exposure or in the 
two-generation reproduction study following pre- and post-natal 
exposure. Fetal toxicity, manifested as significantly lower fetal 
weights and an increased incidence of delayed ossification in the rat 
and a slight increase in litters showing extra ribs (13th) in the 
rabbit, was reported in developmental toxicity studies. In a rat two-
generation reproduction study, significantly lower pup weights for F 1 
and F 2 offspring were observed. However, each of these fetal/neonatal 
effects occurred at the same dose levels at which maternal toxicity 
(decreased body weight gain) was observed and were considered to be 
secondary to maternal toxicity.
    Based on the lack of evidence of carcinogenicity in mice and rats 
at doses that were judged to be adequate to the carcinogenic potential, 
cyprodinil was classified as ``not likely to be carcinogenic to 
humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by cyprodinil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, ``Human Health Risk Assessment for 
Registration Review and New Use Risk Assessment to Support the 
Registration of Proposed Use on Crop Subgroup 1C'' in docket ID number 
EPA-HQ-OPP-2015-0646.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which the NOAEL and the LOAEL are identified. 
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 cyprodinil used for 
human risk assessment is discussed in Unit III.B of the final rule 
published in the Federal Register of August 17, 2012 (77 FR 49732) 
(FRL-9359-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyprodinil, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyprodinil tolerances in 40 CFR 
180.532.
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for cyprodinil. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA). This dietary survey was 
conducted from 2003 to 2008. As to residue levels in food, EPA utilized 
the Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database DEEM-FCID, Version 3.16 default processing factors and 
tolerance-level residues and 100 percent crop treated (PCT) for all 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA dietary survey conducted from 2003 to 2008. As to residue levels 
in food, EPA tolerance-level residues were used for most commodities, 
and average field trial residues were used for pome fruit, head 
lettuce, leaf lettuce, spinach, tomato, and grapes. 100 PCT assumptions 
were used for all commodities. DEEM default and empirical processing 
factors were used to modify the tolerance values.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that cyprodinil 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)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for cyprodinil and CGA 249287 in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of cyprodinil and CGA 249287. 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.

[[Page 47307]]

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), Screening Concentration in Ground Water (SCI-GROW) 
models and Pesticide Root Zone Model Ground Water (PRZM GW), the 
estimated drinking water concentrations (EDWCs) of cyprodinil and CGA 
249287 for acute exposures are estimated to be 34.8 parts per billion 
(ppb) for surface water and 2.05 ppb for ground water. EDWCs for 
chronic exposures for non-cancer assessments are estimated to be 24.7 
ppb for surface water and 1.80 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 34.8 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 24.7 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Cyprodinil is 
currently registered for the following uses that could result in 
residential exposures: Ornamental plants. EPA assessed residential 
exposure using the following assumptions: Only short-term inhalation 
exposures to adult residential handlers from application to ornamental 
plants. Though there may be short-term dermal exposures to handlers, 
this was not assessed since no dermal endpoint was identified. Post-
application exposures to adults and children are not expected. 
Intermediate or chronic exposures are not expected. 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.''
    EPA has not found cyprodinil to share a common mechanism of 
toxicity with any other substances, and cyprodinil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyprodinil does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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. In a rat developmental 
toxicity study, there were significantly lower mean fetal weights in 
the high-dose group compared to controls as well as a significant 
increase in skeletal anomalies in the high-dose group due to abnormal 
ossification. The skeletal anomalies/variations were considered to be a 
transient developmental delay that occurs secondary to the maternal 
toxicity noted in the high-dose group. In the rabbit study, the only 
treatment related developmental effect was indication of an increased 
incidence of a 13th rib at maternally toxic doses. Signs of fetal 
effects in the two-generation reproductive toxicity study included 
significantly lower F1 and F2 pup weights in the 
high-dose group during lactation, which continued to be lower than 
controls post-weaning and after the pre-mating period in the 
F1 generation only. Reproductive effects were seen only at 
doses that also caused parental toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for non-inhalation routes of exposure and 
retained at 10X for inhalation exposure scenarios for all population 
groups. That decision is based on the following findings:
    i. The toxicity database for cyprodinil is complete, except for a 
90-day inhalation toxicity study required to reduce uncertainty 
associated with the use of an oral POD for assessing risk via the 
inhalation route. In the absence of a route-specific inhalation study, 
a 10x FQPA SF factor for residential scenarios will be retained for 
risk assessments involving inhalation exposure.
    ii. As indicated by an acute neurotoxicity study in mice, clinical 
signs, hypothermia, and changes in motor activity were all found to be 
reversible and no longer seen at day 8. There were no treatment related 
effects on mortality, gross or histological neuropathology. Reduced 
motor activity, induced hunched posture, piloerection and reduced 
responsiveness to sensory stimuli were observed and disappeared in all 
animals by day 3 to 4. In a sub-chronic neurotoxicity study in rats, 
there were no treatment related effects on mortality, clinical signs, 
or gross or histological neuropathology. No clinical signs suggestive 
of neurobehavioral alterations or evidence of neuropathological effects 
were observed in the available oral-toxicity studies. Based on this 
evidence, there is no need for a developmental neurotoxicity study or 
additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. In the prenatal developmental rat and rabbit studies and in 
the two-generation reproduction rat study, toxicity to the fetuses/
offspring, when observed, occurred at the same doses at which effects 
were observed in maternal/parental animals. All of these fetal effects 
were considered to be secondary to maternal toxicity. There is no 
evidence that cyprodinil results in increased susceptibility in utero 
rats or rabbits in the prenatal developmental studies or in young rats 
in the two-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary assessment was conservative and based on 
100 PCT and tolerance level residues as well as DEEM default and 
empirical processing factors. The chronic dietary assessment was 
partially refined with average field trial residues for some 
commodities and tolerance-level residues for the remaining commodities. 
DEEM default and empirical processing factors were also incorporated 
into the chronic dietary assessment. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to cyprodinil in drinking water. Based on the discussion in 
Unit III.C.3, postapplication exposure of children as well as 
incidental oral exposure of toddlers is not expected. These assessments 
will not

[[Page 47308]]

underestimate the exposure and risks posed by cyprodinil.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to cyprodinil will occupy 8.6% of the aPAD for children one to two 
years old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyprodinil from food and water will utilize 86% of the cPAD for 
children one to two years old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
cyprodinil is not expected.
    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). Cyprodinil is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to cyprodinil. Using the exposure 
assumptions described in this unit for short-term exposures, EPA has 
estimated the short-term food, water, and residential exposures. For 
adults, oral dietary and inhalation estimates were combined using the 
total aggregate risk index (ARI) methodology since the levels of 
concern (LOC) for oral and dietary exposure (LOC = 100) and inhalation 
(LOC 1,000) are different. The short-term ARI for adults is 70 which is 
greater than 1 and is therefore, not of concern.
    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). An intermediate-term adverse effect was identified; however, 
cyprodinil is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
cyprodinil.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, chemical name 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 cyprodinil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (AG-631 and AG-631B) are available 
to enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
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 FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for cyprodinil in/on potato, 
wet peel and vegetable, tuberous and corm, subgroup 1C.

V. Conclusion

    Therefore, tolerances are established for residues of cyprodinil, 
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamin, in or on potato, wet 
peel at 0.03 and vegetable, tuberous and corm, subgroup 1C at 0.01ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 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 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 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

[[Page 47309]]

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 action. In addition, this action does not impose any 
enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act (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 (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: July 11, 2016.
Daniel Kenny,
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. In Sec.  180.532, add alphabetically the commodities ``Potato, wet 
peel'' and ``Vegetable, tuberous and corm, subgroup 1C'' to the table 
in paragraph (a) to read as follows:


Sec.  180.532  Cyprodinil; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Potato, wet peel............................................        0.03
 
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C...................        0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-17268 Filed 7-20-16; 8:45 am]
 BILLING CODE 6560-50-P