82 FR 52669 - Benzovindiflupyr; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 218 (November 14, 2017)
Federal Register Volume 82, Issue 218 (November 14, 2017)
| Page Range | 52669-52674 | |
| FR Document | 2017-24109 |
[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)] [Rules and Regulations] [Pages 52669-52674] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24109] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0448; FRL-9967-33] Benzovindiflupyr; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of benzovindiflupyr in or on the bulb onion subgroup 3-07A, the green onion subgroup 3-07B, and increases an existing tolerance on sugarcane. Interregional Research Project Number 4 (IR-4) and Syngenta Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 14, 2017. Objections and requests for hearings must be received on or before January 16, 2018, 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-2016-0448, 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: Michael Goodis, 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 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 [[Page 52670]] proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP- 2016-0448 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 January 16, 2018. 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-2016-0448, 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 18, 2016 (81 FR 71668) (FRL- 9952-19), 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 6E8483) by IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201-W, Princeton, NJ 08540. The petition requested that 40 CFR 180.686 be amended by establishing tolerances for residues of the fungicide benzovindiflupyr (N-[9-(dichloromethylene)- 1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1- methyl-1H-pyrazole-4-carboxamide) in or on onion, bulb, subgroup 3-07A at 0.02 parts per million (ppm), and onion, green, subgroup 3-07B at 0.4 ppm. In the Federal Register of July 26, 2017 (82 FR 34664) (FRL-9963- 50), 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 6F8499) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested to establish a tolerance in 40 CFR part 180 for residues of the fungicide benzovindiflupyr in or on Sugarcane, cane, at 0.3 ppm. The documents referenced summaries of the petitions prepared by Syngenta Crop Protection, LLC, the registrant, which are available in the dockets EPA-HQ-OPP-2016-0448 and EPA-HQ-OPP-2016-0752 at http://www.regulations.gov. There were no comments received in response to either 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 benzovindiflupyr including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with benzovindiflupyr 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 rat is the most sensitive species tested, and the target organs of benzovindiflupyr are the liver, thyroid, and kidneys. Hepatotoxicity was manifested as changes in liver weights, liver hypertrophy, and decreased triglycerides. The kidney effects were tubular cell pigment deposits, changes in the tubular basophilia, and increased urea. Enlargement and focal c-cell hyperplasia of the thyroid were observed. An increased incidence of cell hypertrophy in the pituitary pars distalis was noted in the F1 generation males and females in the 2- generation reproductive toxicity rat study. Mouse studies revealed distended large intestines, soft feces and hyperplasia of the colon and caecum. Indications of general malaise including decreased body weight and food consumption, decreased activity, decreased grip strength, piloerection, decreased response to stimulus, hunched posture, gait changes and/or ataxia were reported in the rat and mouse studies. In several studies, females tended to be more sensitive than males and effects were generally seen at lower doses with gavage dosing than with dietary dosing. There are no concerns for developmental or reproductive toxicity following benzovindiflupyr exposure. Decreased fetal weight and ossification in the rat developmental toxicity studies occurred at maternally toxic doses. There were no maternal or fetal adverse effects in the rabbit developmental study. In rat reproduction studies, offspring effects (decreased body weight, liver and pituitary effects) occurred at doses higher than those causing parental effects; thus, there was no quantitative increase in sensitivity in rat pups. There were no single-dose developmental effects identified in the developmental toxicity studies in rats or rabbits. Although decreases in growing follicle counts were noted in the 2-generation reproduction toxicity study, this effect did not result in reduced fertility in the rat. Furthermore, the antral follicle counts at a later stage in development were not decreased, so the decreased growing follicle count effect is not considered adverse. No evidence of specific neurotoxicity was observed in the acute oral (gavage) and sub-chronic oral (dietary) neurotoxicity (ACN and SCN) studies in rats, conducted on the benzovindiflupyr technical product. Although [[Page 52671]] benzovindiflupyr caused decreased activity and decreased grip strength in the neurotoxicity studies, there was no supportive neuro- histopathology in any study to indicate a specific neurotoxic effect. The mouse immunotoxicity study was negative by the T-cell Dependent Antigen Response (TDAR) assay in the mouse. No systemic effects were noted at the limit dose of 1,000 milligrams/kilogram/day (mg/kg/day) in the 28-day dermal rat study. The Agency classified benzovindiflupyr as showing ``Suggestive Evidence of Carcinogenic Potential'' based on the presence of granular cell tumors of the brain in male rats only at the highest dose tested. The Agency concluded that a non-genotoxic mode of action for thyroid tumors observed in male rats has been established as a result of upregulation of uridine diphosphate glucuronyltransferase (UDPGT), increased clearance of T3 and T4 hormones, and increased TSH levels, resulting in increased thyroid cell proliferation, which progress to form thyroid tumors. There was no evidence of carcinogenicity in female rats or in male or female mice. In addition, there is no concern for mutagenicity. The Agency has determined that using a non-linear approach (i.e., RfD; reference dose) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to benzovindiflupyr. Specific information on the studies received and the nature of the adverse effects caused by benzovindiflupyr as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Benzovindiflupyr. Human Health Risk Assessment for the Proposed Use on Onion, Bulb Subgroup 3- 07A; Onion, Green, Subgroup 3-07B; and Sugarcane'' on pages 32-38 in docket ID number EPA-HQ-OPP-2016-0448. 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 no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for benzovindiflupyr used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of October 2, 2015 (80 FR 59627) (FRL-9933-03). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to benzovindiflupyr, EPA considered exposure under the petitioned-for tolerances as well as all existing benzovindiflupyr tolerances in 40 CFR 180.686. EPA assessed dietary exposures from benzovindiflupyr in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for benzovindiflupyr. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and tolerance-level residues. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach adequately accounts for all chronic toxicity, including carcinogenicity, that could result from exposure to benzovindiflupyr; therefore, a separate dietary cancer risk assessment was not performed. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for benzovindiflupyr. Tolerance-level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening- level water exposure models in the dietary exposure analysis and risk assessment for benzovindiflupyr in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of benzovindiflupyr. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the Surface Water Concentration Calculator (SWCC) model and the Pesticide Root Zone Model Ground Water (PRZM-GW) model, the estimated drinking water concentrations (EDWCs) of benzovindiflupyr for acute exposures are estimated to be 8.41 parts per billion (ppb) for surface water and 0.14 ppb for ground water and for chronic exposures are estimated to be 5.41 ppb for surface water and 0.14 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 8.41 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 5.41 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). Benzovindiflupyr is currently registered for the following uses that could result in residential exposures: Turf and ornamentals. EPA assessed residential exposure using the following assumptions: For handlers, exposure is expected as a result of application to turf and ornamentals. Post-application exposure is also expected as a result of being in an environment that has been previously treated with benzovindiflupyr. Both handler and [[Page 52672]] post-application exposure is short-term in duration; there are no intermediate- or long term-exposures expected from the residential uses of benzovindiflupyr. Only residential handler inhalation and post- application incidental oral exposure scenarios have been quantitatively assessed since no dermal hazard was identified. Residential handler short-term inhalation MOEs are well above the LOC of 100 for all scenarios assessed and are not of concern (inhalation MOEs are >=180,000). Residential post-application (incidental oral) MOEs for children ranged from 8,000 to 3,600,000 on the day of application, using default input values, and are not of concern (LOC = 100). The residential scenarios used for the benzovindiflupyr aggregate assessments were as follows: Adults: Inhalation exposures from treating ornamentals with a manually pressurized handwand or backpack sprayer; Children 1 to <2 years old: Post-application hand-to-mouth exposures from treated turf. These scenarios resulted in the highest residential exposures and are considered protective of other exposure scenarios. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 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 benzovindiflupyr to share a common mechanism of toxicity with any other substances, and benzovindiflupyr does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that benzovindiflupyr 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides. 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 FQPA Safety Factor (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. There was no evidence of quantitative or qualitative susceptibility in fetuses or offspring in the rat and rabbit developmental studies or in the 2-generation rat reproduction study. Benzovindiflupyr produced effects in rat fetuses (i.e., decreased fetal weight and ossification) in developmental toxicity studies at maternally toxic doses. In the rabbit developmental study, there were no adverse effects in either the does or the fetuses at the highest dose tested. In reproduction studies, offspring effects occurred at doses higher than the doses causing parental effects; thus, there was no quantitative increase in sensitivity in rat pups. The LOAELs and NOAELs for the rat developmental and rat reproduction studies were clearly defined. 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. That decision is based on the following findings: i. The toxicity database for benzovindiflupyr is complete. ii. There is no indication that benzovindiflupyr is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that benzovindiflupyr results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to benzovindiflupyr in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by benzovindiflupyr. 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 benzovindiflupyr will occupy 43% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to benzovindiflupyr from food and water will utilize 19% of the cPAD for children 1-2 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 benzovindiflupyr 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). Benzovindiflupyr 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 benzovindiflupyr. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 2100 for adults and 510 for children. Because EPA's level of concern for benzovindiflupyr is a MOE [[Page 52673]] of 100 or below, these MOEs are 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, benzovindiflupyr 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 benzovindiflupyr. 5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A., EPA considers the chronic aggregate risk assessment to be protective of any aggregate cancer risk. As there is no chronic risk of concern, EPA does not expect any cancer risk to the U.S. population from aggregate exposure to benzovindiflupyr. 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 benzovindiflupyr residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate analytical method is available to enforce the proposed tolerances for benzovindiflupyr in plant and livestock commodities. A Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) multi- residue method (EN15662:2009) was developed for the determination of residues of benzovindiflupyr via liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). 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 any MRLs for benzovindiflupyr. V. Conclusion Therefore, tolerances are established for residues of benzovindiflupyr, including its metabolites and degradates, in or on onion, bulb, subgroup 3-07A at 0.02 ppm; onion, green, subgroup 3-07B at 0.40 ppm; and the existing ``sugarcane, cane'' tolerance is increased from 0.04 ppm to 0.30 ppm. 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 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: October 12, 2017. Michael L. Goodis, Director Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: [[Page 52674]] 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. 180.686, amend the table in paragraph (a) by: 0 i. Adding alphabetically the commodities ``Onion, bulb, subgroup 3- 07A'', ``Onion, green, subgroup 3-07B'', and 0 ii. Revising the commodity ``Sugarcane, cane''. The additions and revisions read as follows: Sec. 180.686 Benzovindiflupyr; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Onion, bulb, subgroup 3-07A.................................. 0.02 Onion, green, subgroup 3-07B................................. 0.40 * * * * * Sugarcane, cane.............................................. 0.30 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2017-24109 Filed 11-13-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52669
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NESHAP. As noted throughout this Authority: This action is issued under the number: (703) 305–7090; email address:
document, the requirement to notify the authority of section 112 of the Clean Air Act, RDFRNotices@epa.gov.
EPA does not apply to sources that have as amended, 42 U.S.C. 7412. SUPPLEMENTARY INFORMATION:
obtained a title V operating permit
Dated: October 25, 2017.
under CT DEEP’s title V operating I. General Information
permit program, already, or that obtain Deborah A. Szaro,
a title V operating permit in the future. Acting Regional Administrator, EPA-New A. Does this action apply to me?
Any source that has received a title V England. You may be potentially affected by
operating permit from CT DEEP will [FR Doc. 2017–24638 Filed 11–13–17; 8:45 am] this action if you are an agricultural
continue to submit demo/reno BILLING CODE 6560–50–P producer, food manufacturer, or
notifications to the State of Connecticut. pesticide manufacturer. The following
list of North American Industrial
III. Do I still need to comply with the ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is
State of Connecticut regulations? AGENCY not intended to be exhaustive, but rather
Nothing in this notification or CT provides a guide to help readers
DEEP’s voluntary, partial withdrawal 40 CFR Part 180
determine whether this document
changes any source’s obligation to [EPA–HQ–OPP–2016–0448; FRL–9967–33] applies to them. Potentially affected
comply with state or local laws. All entities may include:
sources subject to such laws must still Benzovindiflupyr; Pesticide Tolerances • Crop production (NAICS code 111).
comply with the state and local
AGENCY: Environmental Protection • Animal production (NAICS code
regulations. The Connecticut 112).
Agency (EPA).
Department of Public Health • Food manufacturing (NAICS code
implements an asbestos program under ACTION: Final rule.
311).
the Regulations of Connecticut State SUMMARY: This regulation establishes • Pesticide manufacturing (NAICS
Agencies. Sources that are subject to the tolerances for residues of code 32532).
Asbestos NESHAP must also comply benzovindiflupyr in or on the bulb
with the Connecticut Department of B. How can I get electronic access to
onion subgroup 3–07A, the green onion other related information?
Public Health’s asbestos program subgroup 3–07B, and increases an
regulations. This includes potentially existing tolerance on sugarcane. You may access a frequently updated
duplicative notification requirements Interregional Research Project Number 4 electronic version of EPA’s tolerance
for owners or operators of demo/reno (IR–4) and Syngenta Crop Protection regulations at 40 CFR part 180 through
activity subject to the Asbestos requested these tolerances under the the Government Printing Office’s e-CFR
NESHAP, as well as the Connecticut Federal Food, Drug, and Cosmetic Act site at http://www.ecfr.gov/cgi-bin/text-
Department of Public Health’s asbestos (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
program. Owners or operators of 40tab_02.tpl.
affected sources should continue to DATES: This regulation is effective
November 14, 2017. Objections and C. How can I file an objection or hearing
work with their state or local agencies request?
to ensure any applicable requirements requests for hearings must be received
are being met. More information on the on or before January 16, 2018, and must Under FFDCA section 408(g), 21
jstallworth on DSKBBY8HB2PROD with RULES
Connecticut Department of Public Heath be filed in accordance with the U.S.C. 346a, any person may file an
asbestos program can be accessed online instructions provided in 40 CFR part objection to any aspect of this regulation
at www.ct.gov/dph/asbestos. 178 (see also Unit I.C. of the and may also request a hearing on those
SUPPLEMENTARY INFORMATION). objections. You must file your objection
IV. EPA Action ADDRESSES: The docket for this action, or request a hearing on this regulation
Based on CT DEEP’s voluntary and identified by docket identification (ID) in accordance with the instructions
partial withdrawal relating to number EPA–HQ–OPP–2016–0448, is provided in 40 CFR part 178. To ensure
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![52670 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations
proper receipt by EPA, you must In the Federal Register of July 26, the relationship of the results of the
identify docket ID number EPA–HQ– 2017 (82 FR 34664) (FRL–9963–50), studies to human risk. EPA has also
OPP–2016–0448 in the subject line on EPA issued a document pursuant to considered available information
the first page of your submission. All FFDCA section 408(d)(3), 21 U.S.C. concerning the variability of the
objections and requests for a hearing 346a(d)(3), announcing the filing of a sensitivities of major identifiable
must be in writing, and must be pesticide petition (PP 6F8499) by subgroups of consumers, including
received by the Hearing Clerk on or Syngenta Crop Protection, LLC, P.O. infants and children.
before January 16, 2018. Addresses for Box 18300, Greensboro, NC 27419. The The rat is the most sensitive species
mail and hand delivery of objections petition requested to establish a tested, and the target organs of
and hearing requests are provided in 40 tolerance in 40 CFR part 180 for benzovindiflupyr are the liver, thyroid,
CFR 178.25(b). residues of the fungicide and kidneys. Hepatotoxicity was
In addition to filing an objection or benzovindiflupyr in or on Sugarcane, manifested as changes in liver weights,
hearing request with the Hearing Clerk cane, at 0.3 ppm. liver hypertrophy, and decreased
as described in 40 CFR part 178, please The documents referenced summaries triglycerides. The kidney effects were
submit a copy of the filing (excluding of the petitions prepared by Syngenta tubular cell pigment deposits, changes
any Confidential Business Information Crop Protection, LLC, the registrant, in the tubular basophilia, and increased
(CBI)) for inclusion in the public docket. which are available in the dockets EPA– urea. Enlargement and focal c-cell
Information not marked confidential HQ–OPP–2016–0448 and EPA–HQ– hyperplasia of the thyroid were
pursuant to 40 CFR part 2 may be OPP–2016–0752 at http:// observed. An increased incidence of cell
disclosed publicly by EPA without prior www.regulations.gov. There were no hypertrophy in the pituitary pars
notice. Submit the non-CBI copy of your comments received in response to either distalis was noted in the F1 generation
objection or hearing request, identified notice of filing. males and females in the 2-generation
by docket ID number EPA–HQ–OPP– reproductive toxicity rat study. Mouse
III. Aggregate Risk Assessment and
2016–0448, by one of the following studies revealed distended large
Determination of Safety
methods: intestines, soft feces and hyperplasia of
• Federal eRulemaking Portal: http:// Section 408(b)(2)(A)(i) of FFDCA the colon and caecum. Indications of
www.regulations.gov. Follow the online allows EPA to establish a tolerance (the general malaise including decreased
instructions for submitting comments. legal limit for a pesticide chemical body weight and food consumption,
Do not submit electronically any residue in or on a food) only if EPA decreased activity, decreased grip
information you consider to be CBI or determines that the tolerance is ‘‘safe.’’ strength, piloerection, decreased
other information whose disclosure is Section 408(b)(2)(A)(ii) of FFDCA response to stimulus, hunched posture,
restricted by statute. defines ‘‘safe’’ to mean that ‘‘there is a gait changes and/or ataxia were reported
• Mail: OPP Docket, Environmental reasonable certainty that no harm will in the rat and mouse studies. In several
Protection Agency Docket Center (EPA/ result from aggregate exposure to the studies, females tended to be more
DC), (28221T), 1200 Pennsylvania Ave. pesticide chemical residue, including sensitive than males and effects were
NW., Washington, DC 20460–0001. all anticipated dietary exposures and all generally seen at lower doses with
• Hand Delivery: To make special other exposures for which there is gavage dosing than with dietary dosing.
arrangements for hand delivery or reliable information.’’ This includes There are no concerns for
delivery of boxed information, please exposure through drinking water and in developmental or reproductive toxicity
follow the instructions at http:// residential settings, but does not include following benzovindiflupyr exposure.
www.epa.gov/dockets/contacts.html. occupational exposure. Section Decreased fetal weight and ossification
Additional instructions on 408(b)(2)(C) of FFDCA requires EPA to in the rat developmental toxicity studies
commenting or visiting the docket, give special consideration to exposure occurred at maternally toxic doses.
along with more information about of infants and children to the pesticide There were no maternal or fetal adverse
dockets generally, is available at http:// chemical residue in establishing a effects in the rabbit developmental
www.epa.gov/dockets. tolerance and to ‘‘ensure that there is a study. In rat reproduction studies,
reasonable certainty that no harm will offspring effects (decreased body
II. Summary of Petitioned-For
result to infants and children from weight, liver and pituitary effects)
Tolerance
aggregate exposure to the pesticide occurred at doses higher than those
In the Federal Register of October 18, chemical residue. . . .’’ causing parental effects; thus, there was
2016 (81 FR 71668) (FRL–9952–19), Consistent with FFDCA section no quantitative increase in sensitivity in
EPA issued a document pursuant to 408(b)(2)(D), and the factors specified in rat pups. There were no single-dose
FFDCA section 408(d)(3), 21 U.S.C. FFDCA section 408(b)(2)(D), EPA has developmental effects identified in the
346a(d)(3), announcing the filing of a reviewed the available scientific data developmental toxicity studies in rats or
pesticide petition (PP 6E8483) by IR–4, and other relevant information in rabbits. Although decreases in growing
Rutgers, The State University of New support of this action. EPA has follicle counts were noted in the 2-
Jersey, 500 College Road East, Suite sufficient data to assess the hazards of generation reproduction toxicity study,
201–W, Princeton, NJ 08540. The and to make a determination on this effect did not result in reduced
petition requested that 40 CFR 180.686 aggregate exposure for benzovindiflupyr fertility in the rat. Furthermore, the
be amended by establishing tolerances including exposure resulting from the antral follicle counts at a later stage in
for residues of the fungicide tolerances established by this action. development were not decreased, so the
benzovindiflupyr (N-[9- EPA’s assessment of exposures and risks decreased growing follicle count effect
jstallworth on DSKBBY8HB2PROD with RULES
(dichloromethylene)-1,2,3,4-tetrahydro- associated with benzovindiflupyr is not considered adverse.
1,4-methanonaphthalen-5-yl]-3- follows. No evidence of specific neurotoxicity
(difluoromethyl)-1-methyl-1H-pyrazole- was observed in the acute oral (gavage)
4-carboxamide) in or on onion, bulb, A. Toxicological Profile and sub-chronic oral (dietary)
subgroup 3–07A at 0.02 parts per EPA has evaluated the available neurotoxicity (ACN and SCN) studies in
million (ppm), and onion, green, toxicity data and considered its validity, rats, conducted on the benzovindiflupyr
subgroup 3–07B at 0.4 ppm. completeness, and reliability as well as technical product. Although
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![52674 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations
PART 180—[AMENDED] did receive a relevant adverse comment III. How do I access the docket?
on the proposed update, and is therefore To access the docket, please go to
■ 1. The authority citation for part 180 withdrawing the direct final rule and http://www.regulations.gov and follow
continues to read as follows: will instead proceed with a final rule the online instructions using the docket
Authority: 21 U.S.C. 321(q), 346a and 371. based on the proposed rule after identification (ID) number EPA–HQ–
■ 2. In § 180.686, amend the table in
considering all public comments. OPPT–2017–0197. Additional
paragraph (a) by: DATES: Effective November 14, 2017 the information about the Docket Facility is
■ i. Adding alphabetically the direct final rule published in the also provided under ADDRESSES in the
commodities ‘‘Onion, bulb, subgroup 3– Federal Register of August 17, 2017 (82 August 17, 2017 Federal Register
07A’’, ‘‘Onion, green, subgroup 3–07B’’, FR 39038) (FRL–9964–77) is withdrawn. document. If you have questions,
and FOR FURTHER INFORMATION CONTACT: For
consult the technical person listed
■ ii. Revising the commodity technical information contact: under FOR FURTHER INFORMATION
‘‘Sugarcane, cane’’. CONTACT.
Stephanie Griffin, Toxics Release
The additions and revisions read as Inventory Program Division (7410M), IV. Good Cause Finding
follows: Office of Pollution Prevention and EPA finds that there is ‘‘good cause’’
§ 180.686 Benzovindiflupyr; tolerances for Toxics, Environmental Protection under the Administrative Procedure Act
residues. Agency, 1200 Pennsylvania Ave. NW., (APA) (5 U.S.C. 553(b)(3)(B)) to
(a) * * * Washington, DC 20460–0001; telephone withdraw the direct final rule discussed
number: (202) 564–1463; email address: in this document without prior notice
Parts griffin.stephanie@epa.gov. and comment. Alongside the direct final
Commodity per For general information contact: The rule, EPA published an identical
million Emergency Planning and Community proposed rule and gave notice in the
Right-to-Know Information Center; Federal Register that the direct final
* * * * * telephone number: (800) 424–9346, TDD rule would be withdrawn if the Agency
Onion, bulb, subgroup 3–07A ...... 0.02 (800) 553–7672; Web site: https:// received adverse comment.
Onion, green, subgroup 3–07B .... 0.40 www.epa.gov/home/epa-hotlines. For this document, notice and
SUPPLEMENTARY INFORMATION: comment is impracticable and
* * * * * unnecessary because EPA is under a
Sugarcane, cane .......................... 0.30 I. Does this action apply to me? time limit to publish this withdrawal
A list of potentially affected entities is before the direct final rule is to take
* * * * * effect to limit confusion among Federal
provided in the Federal Register of
August 17, 2017. If you have questions agencies and the regulated community.
* * * * * As such, EPA has determined that this
[FR Doc. 2017–24109 Filed 11–13–17; 8:45 am] regarding the applicability of this action
to a particular entity, consult the document is not subject to the 30-day
BILLING CODE 6560–50–P
technical person listed under FOR delay of effective date generally
FURTHER INFORMATION CONTACT. required by 5 U.S.C. 553(d). This
withdrawal must become effective prior
ENVIRONMENTAL PROTECTION II. What rule is being withdrawn? to the effective date of the direct final
AGENCY
In the August 17, 2017 Federal rule being withdrawn.
40 CFR Part 372 Register, EPA published both a direct V. Statutory and Executive Order
[EPA–HQ–OPPT–2017–0197; FRL–9968–26] final rule (see 82 FR 39038) and a Reviews
proposed rule (see 82 FR 39101) This document withdraws regulatory
RIN 2070–AK32 pursuant to sections 313(g)(1) and 328 requirements that have not gone into
of the Emergency Planning and effect. As such, the Agency has
Community Right-to-Know; Adopting Community Right-to-Know Act (EPCRA)
2017 North American Industry determined that this withdrawal will
for the purpose of updating the list of not have any adverse impacts, economic
Classification System (NAICS) Codes NAICS codes subject to TRI reporting
for Toxics Release Inventory (TRI) or otherwise. The statutory and
under EPCRA section 313 to include Executive Order review requirements
Reporting; Withdrawal OMB’s revised 2017 NAICS codes. The applicable to the direct final rule being
AGENCY: Environmental Protection action would have also modified the list withdrawn were discussed in the
Agency (EPA). of relevant exceptions and limitations to August 17, 2017 Federal Register
ACTION: Direct final rule; withdrawal. the covered NAICS codes included in document. Those review requirements
the CFR for TRI reporting purposes. do not apply to this action because it is
SUMMARY: In the Federal Register of Since the direct final rule and a withdrawal and does not contain any
August 17, 2017, EPA published both a proposed rule’s publication, EPA new or amended requirements.
direct final rule and a proposed rule to received a public comment supporting
update the list of NAICS codes subject the overall update, but noting that the VI. Congressional Review Act (CRA)
to reporting under the TRI to reflect the direct final rule inadvertently omitted Pursuant to the CRA (5 U.S.C. 801 et
Office of Management and Budget one of the covered NAICS codes seq.), EPA will submit a report
(OMB) 2017 NAICS code revision. As updated by OMB. As a result of this containing this rule and other required
jstallworth on DSKBBY8HB2PROD with RULES
noted in the direct final rule, if EPA omission, EPA is withdrawing the direct information to the U.S. Senate, the U.S.
received relevant adverse comment on final rule published in the Federal House of Representatives, and the
the proposed update, the Agency would Register on August 17, 2017, and will Comptroller General of the United
publish a timely withdrawal of the instead proceed with a final rule based States prior to publication of the rule in
direct final rule in the Federal Register on the proposed rule after considering the Federal Register. This action is not
informing the public that the direct final (and responding to) all public comments a ‘‘major rule’’ as defined by 5 U.S.C.
action will not take effect. The Agency received. 804(2). Section 808 of the CRA allows
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Document Created: 2018-10-25 10:33:25
Document Modified: 2018-10-25 10:33:25
| 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 November 14, 2017. Objections and requests for hearings must be received on or before January 16, 2018, 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 | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 82 FR 52669 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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