81 FR 47304 - Cyprodinil; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 140 (July 21, 2016)
Federal Register Volume 81, Issue 140 (July 21, 2016)
| Page Range | 47304-47309 | |
| FR Document | 2016-17268 |
[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)] [Rules and Regulations] [Pages 47304-47309] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17268] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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 F 1 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: [email protected]. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 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
![47304 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations
in the Unfunded Mandates Reform Act within which a petition for judicial ENVIRONMENTAL PROTECTION
of 1995 (Public Law 104–4); review may be filed, and shall not AGENCY
• Does not have Federalism postpone the effectiveness of such rule
implications as specified in Executive or action. Parties with objections to this 40 CFR Part 180
Order 13132 (64 FR 43255, August 10, direct final rule are encouraged to file a [EPA–HQ–OPP–2015–0646; FRL–9948–28]
1999); comment in response to the parallel
• Is not an economically significant notice of proposed rulemaking for this Cyprodinil; Pesticide Tolerances
regulatory action based on health or action published in the Proposed Rules
safety risks subject to Executive Order section of today’s Federal Register, AGENCY: Environmental Protection
13045 (62 FR 19885, April 23, 1997); rather than file an immediate petition Agency (EPA).
• Is not a significant regulatory action for judicial review of this direct final ACTION: Final rule.
subject to Executive Order 13211 (66 FR rule, so that the EPA can withdraw this
28355, May 22, 2001); direct final rule and address the SUMMARY: This regulation establishes
• Is not subject to requirements of comment in the proposed rulemaking. tolerances for residues of cyprodinil in
section 12(d) of the National This action may not be challenged later or on vegetable, tuberous and corm,
Technology Transfer and Advancement in proceedings to enforce its subgroup 1C and potato, wet peel.
Act of 1995 (15 U.S.C. 272 note) because requirements (see section 307(b)(2)). Syngenta Crop Protection, LLC
application of those requirements would requested these tolerances under the
be inconsistent with the Clean Air Act; List of Subjects in 40 CFR Part 52 Federal Food, Drug, and Cosmetic Act
and (FFDCA).
• Does not provide the EPA with the Environmental protection, Air
discretionary authority to address, as pollution control, Incorporation by DATES: This regulation is effective July
appropriate, disproportionate human reference, Intergovernmental relations, 21, 2016. Objections and requests for
health or environmental effects, using Reporting and recordkeeping hearings must be received on or before
practicable and legally permissible requirements. September 19, 2016, and must be filed
methods, under Executive Order 12898 Dated: June 24, 2016.
in accordance with the instructions
(59 FR 7629, February 16, 1994). provided in 40 CFR part 178 (see also
Alexis Strauss,
In addition, the SIP is not approved Unit I.C. of the SUPPLEMENTARY
Acting Regional Administrator, Region IX. INFORMATION).
to apply on any Indian reservation land
or in any other area where the EPA or Part 52, Chapter I, Title 40 of the Code ADDRESSES: The docket for this action,
an Indian tribe has demonstrated that a of Federal Regulations is amended as identified by docket identification (ID)
tribe has jurisdiction. In those areas of follows: number EPA–HQ–OPP–2015–0646, is
Indian country, the rule does not have available at http://www.regulations.gov
tribal implications and will not impose PART 52—APPROVAL AND or at the Office of Pesticide Programs
substantial direct costs on tribal PROMULGATION OF Regulatory Public Docket (OPP Docket)
governments or preempt tribal law as IMPLEMENTATION PLANS in the Environmental Protection Agency
specified by Executive Order 13175 (65 Docket Center (EPA/DC), West William
FR 67249, November 9, 2000). ■ 1. The authority citation for part 52 Jefferson Clinton Bldg., Rm. 3334, 1301
The Congressional Review Act, 5 continues to read as follows: Constitution Ave. NW., Washington, DC
U.S.C. 801 et seq., as added by the Small Authority: 42 U.S.C. 7401 et seq. 20460–0001. The Public Reading Room
Business Regulatory Enforcement is open from 8:30 a.m. to 4:30 p.m.,
Fairness Act of 1996, generally provides Subpart F—California Monday through Friday, excluding legal
that before a rule may take effect, the holidays. The telephone number for the
agency promulgating the rule must ■ 2. Section 52.220 is amended by Public Reading Room is (202) 566–1744,
submit a rule report, which includes a adding paragraphs (c)(39)(ii)(J) and and the telephone number for the OPP
copy of the rule, to each House of the (c)(39)(iv)(J) to read as follows: Docket is (703) 305–5805. Please review
Congress and to the Comptroller General the visitor instructions and additional
of the United States. The EPA will § 52.220 Identification of plan—in part.
information about the docket available
submit a report containing this action * * * * * at http://www.epa.gov/dockets.
and other required information to the (c) * * * FOR FURTHER INFORMATION CONTACT:
U.S. Senate, the U.S. House of (39) * * * Susan Lewis, Registration Division
Representatives, and the Comptroller (7505P), Office of Pesticide Programs,
General of the United States prior to (ii) * * *
Environmental Protection Agency, 1200
publication of the rule in the Federal (J) Previously approved on November Pennsylvania Ave. NW., Washington,
Register. A major rule cannot take effect 9, 1978 in paragraph (c)(39)(ii)(B) of this DC 20460–0001; main telephone
until 60 days after it is published in the section and now deleted without number: (703) 305–7090; email address:
Federal Register. This action is not a replacement: Rules 213, 213.1, and RDFRNotices@epa.gov.
‘‘major rule’’ as defined by 5 U.S.C. 213.2.
SUPPLEMENTARY INFORMATION:
804(2). * * * * *
Under section 307(b)(1) of the Clean I. General Information
(iv) * * *
Air Act, petitions for judicial review of
this action must be filed in the United (J) Previously approved on November A. Does this action apply to me?
States Court of Appeals for the 9, 1978 in paragraph (c)(39)(iv)(B) of You may be potentially affected by
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appropriate circuit by September 19, this section and now deleted without this action if you are an agricultural
2016. Filing a petition for replacement: Rules 213, 213.1, and producer, food manufacturer, or
reconsideration by the Administrator of 213.2. pesticide manufacturer. The following
this final rule does not affect the finality * * * * * list of North American Industrial
of this action for the purposes of judicial [FR Doc. 2016–17171 Filed 7–20–16; 8:45 am] Classification System (NAICS) codes is
review nor does it extend the time BILLING CODE 6560–50–P not intended to be exhaustive, but rather
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![Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations 47309
relationship between the national Parts per holidays. The telephone number for the
Commodity
government and the States or tribal million Public Reading Room is (202) 566–1744,
governments, or on the distribution of and the telephone number for the OPP
power and responsibilities among the Docket is (703) 305–5805. Please review
various levels of government or between * * * * * the visitor instructions and additional
Potato, wet peel .......................... 0.03
the Federal Government and Indian information about the docket available
tribes. Thus, the Agency has determined * * * * * at http://www.epa.gov/dockets.
that Executive Order 13132, entitled Vegetable, tuberous and corm, FOR FURTHER INFORMATION CONTACT:
‘‘Federalism’’ (64 FR 43255, August 10, subgroup 1C ........................... 0.01 Robert McNally, Biopesticides and
1999) and Executive Order 13175, Pollution Prevention Division (7511P),
entitled ‘‘Consultation and Coordination * * * * * Office of Pesticide Programs,
with Indian Tribal Governments’’ (65 FR Environmental Protection Agency, 1200
67249, November 9, 2000) do not apply * * * * * Pennsylvania Ave. NW., Washington,
to this action. In addition, this action [FR Doc. 2016–17268 Filed 7–20–16; 8:45 am]
DC 20460–0001; main telephone
does not impose any enforceable duty or BILLING CODE 6560–50–P number: (703) 305–7090; email address:
contain any unfunded mandate as BPPDFRNotices@epa.gov.
described under Title II of the Unfunded SUPPLEMENTARY INFORMATION:
Mandates Reform Act (UMRA) (2 U.S.C. ENVIRONMENTAL PROTECTION
1501 et seq.). AGENCY I. General Information
This action does not involve any 40 CFR Part 180 A. Does this action apply to me?
technical standards that would require You may be potentially affected by
Agency consideration of voluntary [EPA–HQ–OPP–2014–0329; FRL–9945–41]
this action if you are an agricultural
consensus standards pursuant to section producer, food manufacturer, or
12(d) of the National Technology Isaria fumosorosea Strain FE 9901;
Exemption From the Requirement of a pesticide manufacturer. The following
Transfer and Advancement Act list of North American Industrial
(NTTAA) (15 U.S.C. 272 note). Tolerance
Classification System (NAICS) codes is
VII. Congressional Review Act AGENCY: Environmental Protection not intended to be exhaustive, but rather
Agency (EPA). provides a guide to help readers
Pursuant to the Congressional Review ACTION: Final rule. determine whether this document
Act (5 U.S.C. 801 et seq.), EPA will applies to them. Potentially affected
submit a report containing this rule and SUMMARY: This regulation establishes an entities may include:
other required information to the U.S. exemption from the requirement of a • Crop production (NAICS code 111).
Senate, the U.S. House of tolerance for residues of Isaria • Animal production (NAICS code
Representatives, and the Comptroller fumosorosea strain FE 9901 in or on all 112).
General of the United States prior to food commodities when used in • Food manufacturing (NAICS code
publication of the rule in the Federal accordance with label directions and 311).
Register. This action is not a ‘‘major good agricultural practices. Novozymes • Pesticide manufacturing (NAICS
rule’’ as defined by 5 U.S.C. 804(2). BioAg, Inc. submitted a petition to EPA code 32532).
under the Federal Food, Drug, and
List of Subjects in 40 CFR Part 180 B. How can I get electronic access to
Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a other related information?
Environmental protection,
Administrative practice and procedure, tolerance. This regulation eliminates the You may access a frequently updated
Agricultural commodities, Pesticides need to establish a maximum electronic version of 40 CFR part 180
and pests, Reporting and recordkeeping permissible level for residues of Isaria through the Government Printing
requirements. fumosorosea strain FE 9901 under Office’s e-CFR site at http://
Dated: July 11, 2016.
FFDCA. www.ecfr.gov/cgi-bin/text-
DATES: This regulation is effective July idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Daniel Kenny,
21, 2016. Objections and requests for 40tab_02.tpl.
Acting Director, Registration Division, Office
of Pesticide Programs. hearings must be received on or before C. How can I file an objection or hearing
September 19, 2016, and must be filed request?
Therefore, 40 CFR chapter I is in accordance with the instructions
amended as follows: Under FFDCA section 408(g), 21
provided in 40 CFR part 178 (see also U.S.C. 346a(g), any person may file an
Unit I.C. of the SUPPLEMENTARY objection to any aspect of this regulation
PART 180—[AMENDED] INFORMATION).
and may also request a hearing on those
■ 1. The authority citation for part 180 ADDRESSES: The docket for this action, objections. You must file your objection
continues to read as follows: identified by docket identification (ID) or request a hearing on this regulation
number EPA–HQ–OPP–2014–0329, is in accordance with the instructions
Authority: 21 U.S.C. 321(q), 346a and 371.
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure
■ 2. In § 180.532, add alphabetically the or at the Office of Pesticide Programs proper receipt by EPA, you must
commodities ‘‘Potato, wet peel’’ and Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ–
‘‘Vegetable, tuberous and corm, in the Environmental Protection Agency OPP–2014–0329 in the subject line on
Lhorne on DSK30JT082PROD with RULES
subgroup 1C’’ to the table in paragraph Docket Center (EPA/DC), West William the first page of your submission. All
(a) to read as follows: Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
Constitution Ave. NW., Washington, DC must be in writing, and must be
§ 180.532 Cyprodinil; tolerances for 20460–0001. The Public Reading Room received by the Hearing Clerk on or
residues. is open from 8:30 a.m. to 4:30 p.m., before September 19, 2016. Addresses
(a) General. (1) * * * Monday through Friday, excluding legal for mail and hand delivery of objections
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Document Created: 2018-02-08 07:59:03
Document Modified: 2018-02-08 07:59:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| 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). | |
| Contact | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 81 FR 47304 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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