82 FR 27149 - Isofetamid; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 113 (June 14, 2017)
Federal Register Volume 82, Issue 113 (June 14, 2017)
| Page Range | 27149-27154 | |
| FR Document | 2017-12346 |
[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)] [Rules and Regulations] [Pages 27149-27154] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12346] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0263; FRL-9961-80] Isofetamid; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of isofetamid in or on multiple commodities which are identified and discussed later in this document. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). The regulation also removes the existing time-limited tolerances for residues on ``bushberry subgroup 13-07B'' and ``caneberry subgroup 13-07A'' because they are no longer needed as a result of this action. DATES: This regulation is effective June 14, 2017. Objections and requests for hearings must be received on or before August 14, 2017, 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-2016-0263, 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 L. 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: [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 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-2016-0263 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 August 14, 2017. 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-2016-0263, 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 [[Page 27150]] dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956- 86), 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 6F8457) by ISK Biosciences Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077. The petition requested that 40 CFR 180.681 be amended by establishing tolerances for residues of the fungicide isofetamid, N-[1,1-dimethyl-2-[2-methyl-4-(1-methylethoxy)phenyl]-2- oxoethyl]-3-methyl-2-thiophenecarboxamide, in or on caneberry subgroup 13-07A at 3.0 parts per million (ppm); apple, wet pomace, at 2.0 ppm; bushberry, subgroup 13-07B at 6.0 ppm; cattle, fat at 0.01 ppm; cattle, meat byproducts at 0.01 ppm; cherry subgroup 12-12A at 5.0 ppm; fruit, pome, group 11-10 at 0.6 ppm; fruit, small vine climbing, except grape, subgroup 13-7E at 9.0 ppm; goat, fat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; horse, fat at 0.01 ppm; horse, meat byproducts at 0.01 ppm; pea and bean, dried shelled, except soybean, subgroup 6C, except cowpea and field pea at 0.05 ppm; pea and bean, succulent shelled, subgroup 6B, except cowpea at 0.04 ppm; peach subgroup 12-12B at 3.0 ppm; plum, prune, dried at 3.5 ppm; plum subgroup 12-12C at 0.8 ppm; sheep, fat at 0.01 ppm; sheep, meat byproducts at 0.01 ppm; and vegetable, legume, edible podded, subgroup 6A at 1.5 ppm. That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has revised some of the proposed tolerances; determined that tolerances for residues in livestock commodities are not required; and corrected some of the commodity definitions. The reason for these changes are explained in Unit IV.D. 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 isofetamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with isofetamid 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 toxicology database is complete for isofetamid. In repeated dose studies, the liver was the primary target organ in the rat, mouse, and dog, as indicated by increased liver weights, changes in the clinical chemistry values, and liver hypertrophy. A second target organ was the thyroid in the rat and dog, as indicated by changes in thyroid weights and histopathology. Adrenal weight changes were observed in the subchronic rat and dog studies. In the rat and dog, the dose levels where toxicity was observed were similar or higher in the chronic studies compared with the respective subchronic studies, showing an absence of progression of liver toxicity with time. There was no evidence of carcinogenicity in the rat or mouse cancer studies; the mutagenicity battery was negative. There are no genotoxicity, neurotoxicity, or immunotoxicity concerns observed in the available toxicity studies. Developmental toxicity was not observed in the rat or rabbit, and offspring effects such as decreased body weight were seen only in the presence of parental toxicity in the multi-generation rat study. Isofetamid is classified as ``Not Likely to be Carcinogenic to Humans'' based on the absence of increased tumor incidence in acceptable/guideline carcinogenicity studies in rats and mice. Isofetamid is not acutely toxic; it is classified as Toxicity Category III for acute oral and dermal exposure, and Toxicity Category IV for inhalation exposure. Furthermore, it is not irritating to the eye or skin, and it is not a dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by isofetamid as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies are can be found at http://www.regulations.gov in document Isofetamid. Aggregate Human Health Risk Assessment for the Proposed New Agricultural Uses on Bushberry, Subgroup 13-07B; Caneberry, Subgroup 13-07A; Cherry, Subgroup 12-12A; Dried Shelled Pea and Bean, Except Soybean, Subgroup 6C; Edible-Podded Legume Vegetables, Subgroup 6A; Peach, Subgroup 12-12B; Plum, Subgroup 12-12C; Pome Fruit, Group 11-10; Small Vine Climbing Fruit, Except Grape, Subgroup 13-07E; Succulent Shelled Pea and Bean, Subgroup 6B; as well as Livestock Commodities; in Addition to Uses on Ornamental Plants (including Residential Use Sites). pages 12-18 in docket ID number EPA- HQ-OPP-2016-0263. 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 [[Page 27151]] 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 isofetamid used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 30, 2015 (80 FR 45440) (FRL- 9923-86). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isofetamid, EPA considered exposure under the petitioned- for tolerances as well as all existing isofetamid tolerances in 40 CFR 180.681. EPA assessed dietary exposures from isofetamid 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. No such effects were identified in the toxicological studies for isofetamid; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. An unrefined chronic (food and drinking water) dietary assessment was conducted for all registered and proposed food uses of isofetamid using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The chronic dietary (food and drinking water) exposure assessment for isofetamid incorporated existing tolerance-level residues, Agency-recommended tolerance-level residues for proposed tolerances, DEEM default processing factors, and 100 PCT (percent crop treated). Some tolerance levels were adjusted to include residues of the metabolite, GPTC (a residue of concern for risk assessment). DEEM default processing factors were used for dried apples, apple juice, dried pear, cherry juice, dried apricot, dried peach, plum, prune juice, cranberry juice, and grape juice. The EDWC of 110 microgram/Liter ([micro]g/L) was incorporated directly into the dietary assessment. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that isofetamid 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. EPA did not use anticipated residue and/or PCT information in the dietary assessment for isofetamid. Tolerance level residues and/or 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 isofetamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of isofetamid. 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 Pesticide Flooded Application Model and the Pesticide Root Zone Model Ground Water (PRZM GW) the estimated drinking water concentrations (EDWCs) of isofetamid for chronic exposures for non- cancer assessments are estimated to be 110 parts per billion (ppb) for surface water and 43 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 110 ppb was used to assess the contribution from 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). Isofetamid is currently registered for the following uses that could result in residential exposures: Turfgrass including golf courses, residential lawns, and recreational turfgrass. It is currently under review for registering use on ornamental plants. The proposed ornamental use is not intended for homeowner use and therefore a quantitative residential handler assessment was not conducted. Additionally, post-application exposures for adults and children are expected to be negligible. However, the existing turf use may result in short- and intermediate-term exposures. Residential exposure may occur by the dermal and incidental oral routes of exposures following the application of isofetamid on residential turf. However, since dermal hazard has not been identified for isofetamid, the only exposure scenario quantitatively assessed is for post-application incidental oral (for children 1 to <2 years old). These exposures have been assessed with current policies, which include the Agency's 2012 Residential Standard Operating Procedures (http://www.epa.gov/pesticides/science/residential-exposure-sop.html) along with policy changes for body weight assumptions. Even though a previous risk assessment identified residential handler risk estimates for use in aggregate assessment, based on current policy and that isofetamid products are intended for sale/use to/by professional applicators, residential handler exposure assessments for turf are no longer applicable to the isofetamid aggregate risk assessment. Therefore, the aggregate assessment for this action only includes a risk contribution from residential post- application incidental oral exposure for children 1 to <2 years old. There is the potential for post-application exposure for individuals as a result of being in an environment that has been previously treated with isofetamid such as residential ornamental lawns. Since dermal hazard has not been identified for isofetamid, a quantitative assessment for dermal exposure is not necessary and the only exposure scenarios quantitatively assessed are for children 1 to <2 years old who may experience short-term incidental oral exposure to isofetamid from treated turf. Intermediate-term incidental oral post- application exposures are possible (i.e., from soil ingestion due to the persistence of isofetamid); however, the short-term incidental oral exposures are protective of the possible intermediate-term incidental oral exposures because the POD for both durations is the same. Post- application inhalation exposure is expected to be negligible for the proposed residential uses. The post-application incidental oral MOE values were calculated based on the scenario of liquid application of isofetamid to turf. Post-application risk estimates for all incidental oral scenarios are not of concern (MOEs range from 5,900 to 4,000,000). The incidental oral scenarios (i.e., hand-to-mouth and object-to-mouth) should be considered inter-related and it is likely that they occur interspersed amongst [[Page 27152]] each other across time. However, combining these scenarios would be overly-conservative because of the conservative nature of each individual assessment. Incidental oral risk estimates are highly conservative because the short- and intermediate-term incidental oral POD is based on a 90-day exposure duration which represents daily exposure for 90 days. 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 isofetamid to share a common mechanism of toxicity with any other substances, and isofetamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isofetamid 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 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. There is no evidence of developmental toxicity or reproductive susceptibility, and there are no residual uncertainties concerning pre- or post-natal toxicity or exposure. 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 isofetamid is complete. ii. There is no indication that isofetamid 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 isofetamid 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 isofetamid 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 isofetamid. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, isofetamid is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isofetamid from food and water will utilize 4.0% 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 isofetamid 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). Isofetamid 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 isofetamid. 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 an aggregate MOE of 1,600 for children (1-2 years old). Because EPA's level of concern for isofetamid is a MOE of 100 or below, this MOE is 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, isofetamid 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 isofetamid. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, isofetamid 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 isofetamid residues. [[Page 27153]] IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology liquid chromatography with tandem mass spectrometry (LC-MS/MS) method is available to enforce the tolerance expression. Multiresidue methods testing data have been submitted for isofetamid and GPTC. The data indicate that multiresidue methods are not suitable for analysis of isofetamid and GPTC, so the multiresidue methods cannot serve as enforcement methods. The multiresidue data have been forwarded to the Food and Drug Administration (FDA). 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 MRLs for isofetamid. There are no Canadian, Codex, or Mexican maximum residue limits (MRLs) for isofetamid in/on the commodities included in this petition. C. Revisions to Petitioned-For Tolerances All tolerance levels are based upon the Organization for Economic Co-operation and Development's (OECD) tolerance calculation procedures. Thus, the tolerance levels established in this notice for isofetamid in/on bushberry, subgroup 13-07B; cherry, subgroup 12-12A; plum, prune, dried; dried shelled pea and bean, except soybean, subgroup 6C; and succulent shelled pea and bean, subgroup 6B are lower than those requested by the petitioner. The tolerance levels established in this notice for caneberry, subgroup 13-07A and fruit, small vine climbing, except grape, subgroup 13-07E are higher than those requested by the petitioner based on the OECD calculation procedures. Additionally, the Agency has determined that tolerances requested for residues in livestock commodities are not required. These tolerances fall under 40 CFR 180.6(a)(3) regarding secondary residues in livestock commodities, i.e., it is not possible to establish with certainty whether finite residues will be incurred, but there is no reasonable expectation of finite residues. The following commodity definitions have been corrected: Bushberry subgroup 13-07B; fruit, small vine climbing, except grape, subgroup 13- 07E; pea and bean, dried shelled, except soybean, subgroup 6C; and pea and bean, succulent shelled, subgroup 6B. V. Conclusion Therefore, tolerances are established for residues of isofetamid, in or on apple, wet pomace, at 2.0 parts per million (ppm); bushberry subgroup 13-07B at 5.0 ppm; caneberry subgroup 13-07A at 4.0 ppm; cherry subgroup 12-12A at 4.0 ppm; fruit, pome, group 11-10 at 0.60 ppm; fruit, small vine climbing, except grape, subgroup 13-07E at 10.0 ppm; pea and bean, dried shelled, except soybean, subgroup 6C, at 0.040 ppm; pea and bean, succulent shelled, subgroup 6B, at 0.030 ppm; peach subgroup 12-12B at 3.0 ppm; plum, prune, dried at 1.50 ppm; plum subgroup 12-12C at 0.80 ppm; and vegetable, legume, edible podded, subgroup 6A at 1.50 ppm. Additionally, the existing time-limited tolerances are being removed for both Caneberry subgroup 13-07A at 4.0 ppm, and for Bushberry subgroup 13-07B at 5.0 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 [[Page 27154]] and pests, Reporting and recordkeeping requirements. Dated: May 4, 2017. Michael Goodis, 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. Section 180.681 is amended as follows: 0 a. In the table in paragraph (a) alphabetically add the following commodities: ``Apple, wet pomace''; ``Bushberry subgroup 13-07B''; ``Caneberry subgroup 13-07A''; ``Cherry subgroup 12-12A''; ``Fruit, pome, group 11-10''; ``Fruit, small vine climbing, except grape, subgroup 13-07E''; ``Pea and bean, dried shelled, except soybean, subgroup 6C''; ``Pea and bean, succulent shelled, subgroup 6B''; ``Peach subgroup 12-12B''; ``Plum, Prune, Dried''; ``Plum subgroup 12- 12C''; ``Vegetable, legume, edible podded, subgroup 6A''. 0 b. Paragraph (b) is revised. The additions and revision read as follows: Sec. 180.681 Isofetamid; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Apple, wet pomace.......................................... 2.0 Bushberry subgroup 13-07B.................................. 5.0 Caneberry subgroup 13-07A.................................. 4.0 * * * * * Cherry subgroup 12-12A..................................... 4.0 * * * * * Fruit, pome, group 11-10................................... 0.60 * * * * * Fruit, small vine climbing, except grape, subgroup 13-07E.. 10.0 * * * * * Pea and bean, dried shelled, except soybean, subgroup 6C... 0.040 Pea and bean, succulent shelled, subgroup 6B............... 0.030 Peach subgroup 12-12B...................................... 3.0 Plum, Prune, Dried......................................... 1.50 Plum subgroup 12-12C....................................... 0.80 * * * * * Vegetable, legume, edible podded, subgroup 6A.............. 1.50 ------------------------------------------------------------------------ (b) Section 18 emergency exemptions. [Reserved] * * * * * [FR Doc. 2017-12346 Filed 6-13-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations 27149
List of Subjects in 40 CFR Part 180 SUMMARY: This regulation establishes • Food manufacturing (NAICS code
Environmental protection, tolerances for residues of isofetamid in 311).
Administrative practice and procedure, or on multiple commodities which are • Pesticide manufacturing (NAICS
Agricultural commodities, Pesticides identified and discussed later in this code 32532).
and pests, Reporting and recordkeeping document. ISK Biosciences Corporation B. How can I get electronic access to
requirements. requested these tolerances under the other related information?
Federal Food, Drug, and Cosmetic Act
Dated: May 8, 2017. (FFDCA). The regulation also removes You may access a frequently updated
Michael Goodis, the existing time-limited tolerances for electronic version of EPA’s tolerance
Director, Registration Division, Office of residues on ‘‘bushberry subgroup 13– regulations at 40 CFR part 180 through
Pesticide Programs. 07B’’ and ‘‘caneberry subgroup 13–07A’’ the Government Printing Office’s e-CFR
Therefore, 40 CFR chapter I is because they are no longer needed as a site at http://www.ecfr.gov/cgi-bin/text-
amended as follows: result of this action. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
DATES: This regulation is effective June
40tab_02.tpl.
PART 180—[AMENDED] 14, 2017. Objections and requests for C. How can I file an objection or hearing
■ 1. The authority citation for part 180 hearings must be received on or before request?
continues to read as follows: August 14, 2017, and must be filed in Under FFDCA section 408(g), 21
accordance with the instructions U.S.C. 346a, any person may file an
Authority: 21 U.S.C. 321(q), 346a and 371. provided in 40 CFR part 178 (see also objection to any aspect of this regulation
■ 2. In § 180.641, in the table in Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those
paragraph (a)(1): INFORMATION).
objections. You must file your objection
■ i. Add alphabetically the entries: The docket for this action,
ADDRESSES: or request a hearing on this regulation
‘‘Beet, sugar, molasses’’; ‘‘Beet, sugar, identified by docket identification (ID) in accordance with the instructions
roots’’; ‘‘Carrot, roots’’; ‘‘Fruit, stone, number EPA–HQ–OPP–2016–0263, is provided in 40 CFR part 178. To ensure
group 12–12’’; and ‘‘Nut, tree, group 14– available at http://www.regulations.gov proper receipt by EPA, you must
12’’; and or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
■ ii. Remove entries for ‘‘Fruit, stone,
Regulatory Public Docket (OPP Docket) OPP–2016–0263 in the subject line on
group 12’’ and ‘‘Nut, tree, group 14’’. in the Environmental Protection Agency the first page of your submission. All
The additions read as follows: Docket Center (EPA/DC), West William objections and requests for a hearing
§ 180.641 Spirotetramat; tolerances for Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
residues. Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
(a) * * * 20460–0001. The Public Reading Room before August 14, 2017. Addresses for
(1) * * * is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
Monday through Friday, excluding legal and hearing requests are provided in 40
Parts per holidays. The telephone number for the CFR 178.25(b).
Commodity million Public Reading Room is (202) 566–1744, In addition to filing an objection or
and the telephone number for the OPP hearing request with the Hearing Clerk
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
* * * * *
the visitor instructions and additional submit a copy of the filing (excluding
Beet, sugar, molasses ................ 0.30
Beet, sugar, roots ....................... 0.15 information about the docket available any Confidential Business Information
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
* * * * * FOR FURTHER INFORMATION CONTACT: Information not marked confidential
Carrot, roots ................................ 0.15 Michael L. Goodis, Registration Division pursuant to 40 CFR part 2 may be
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
* * * * * Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
Fruit, stone, group 12–12 ........... 4.5 objection or hearing request, identified
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
* * * * *
number: (703) 305–7090; email address: 2016–0263, by one of the following
Nut, tree, group 14–12 ............... 0.25
RDFRNotices@epa.gov. methods:
* * * * * • Federal eRulemaking Portal: http://
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online
* * * * * I. General Information instructions for submitting comments.
Do not submit electronically any
[FR Doc. 2017–12348 Filed 6–13–17; 8:45 am] A. Does this action apply to me?
information you consider to be CBI or
BILLING CODE 6560–50–P You may be potentially affected by other information whose disclosure is
this action if you are an agricultural restricted by statute.
producer, food manufacturer, or • Mail: OPP Docket, Environmental
ENVIRONMENTAL PROTECTION pesticide manufacturer. The following Protection Agency Docket Center (EPA/
AGENCY list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
40 CFR Part 180 Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
not intended to be exhaustive, but rather • Hand Delivery: To make special
mstockstill on DSK30JT082PROD with RULES
[EPA–HQ–OPP–2016–0263; FRL–9961–80] provides a guide to help readers arrangements for hand delivery or
determine whether this document delivery of boxed information, please
Isofetamid; Pesticide Tolerances applies to them. Potentially affected follow the instructions at http://
AGENCY: Environmental Protection entities may include: www.epa.gov/dockets/contacts.html.
Agency (EPA). • Crop production (NAICS code 111). Additional instructions on
ACTION: Final rule.
• Animal production (NAICS code commenting or visiting the docket,
112). along with more information about
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![27150 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations
dockets generally, is available at http:// result from aggregate exposure to the weight were seen only in the presence
www.epa.gov/dockets. pesticide chemical residue, including of parental toxicity in the multi-
all anticipated dietary exposures and all generation rat study. Isofetamid is
II. Summary of Petitioned-For
other exposures for which there is classified as ‘‘Not Likely to be
Tolerance
reliable information.’’ This includes Carcinogenic to Humans’’ based on the
In the Federal Register of February 7, exposure through drinking water and in absence of increased tumor incidence in
2017 (82 FR 9555) (FRL–9956–86), EPA residential settings, but does not include acceptable/guideline carcinogenicity
issued a document pursuant to FFDCA occupational exposure. Section studies in rats and mice. Isofetamid is
section 408(d)(3), 21 U.S.C. 346a(d)(3), 408(b)(2)(C) of FFDCA requires EPA to not acutely toxic; it is classified as
announcing the filing of a pesticide give special consideration to exposure Toxicity Category III for acute oral and
petition (PP 6F8457) by ISK Biosciences of infants and children to the pesticide dermal exposure, and Toxicity Category
Corporation, 7470 Auburn Rd., Suite A, chemical residue in establishing a IV for inhalation exposure. Furthermore,
Concord, OH 44077. The petition tolerance and to ‘‘ensure that there is a it is not irritating to the eye or skin, and
requested that 40 CFR 180.681 be reasonable certainty that no harm will it is not a dermal sensitizer.
amended by establishing tolerances for result to infants and children from Specific information on the studies
residues of the fungicide isofetamid, N- aggregate exposure to the pesticide received and the nature of the adverse
[1,1-dimethyl-2-[2-methyl-4-(1- chemical residue . . . .’’ effects caused by isofetamid as well as
methylethoxy)phenyl]-2-oxoethyl]-3- Consistent with FFDCA section the no-observed-adverse-effect-level
methyl-2-thiophenecarboxamide, in or 408(b)(2)(D), and the factors specified in (NOAEL) and the lowest-observed-
on caneberry subgroup 13–07A at 3.0 FFDCA section 408(b)(2)(D), EPA has adverse-effect-level (LOAEL) from the
parts per million (ppm); apple, wet reviewed the available scientific data toxicity studies are can be found at
pomace, at 2.0 ppm; bushberry, and other relevant information in http://www.regulations.gov in document
subgroup 13–07B at 6.0 ppm; cattle, fat support of this action. EPA has Isofetamid. Aggregate Human Health
at 0.01 ppm; cattle, meat byproducts at sufficient data to assess the hazards of Risk Assessment for the Proposed New
0.01 ppm; cherry subgroup 12–12A at and to make a determination on Agricultural Uses on Bushberry,
5.0 ppm; fruit, pome, group 11–10 at 0.6 aggregate exposure for isofetamid Subgroup 13–07B; Caneberry, Subgroup
ppm; fruit, small vine climbing, except including exposure resulting from the 13–07A; Cherry, Subgroup 12–12A;
grape, subgroup 13–7E at 9.0 ppm; goat, tolerances established by this action. Dried Shelled Pea and Bean, Except
fat at 0.01 ppm; goat, meat byproducts EPA’s assessment of exposures and risks Soybean, Subgroup 6C; Edible-Podded
at 0.01 ppm; horse, fat at 0.01 ppm; associated with isofetamid follows. Legume Vegetables, Subgroup 6A;
horse, meat byproducts at 0.01 ppm; pea Peach, Subgroup 12–12B; Plum,
and bean, dried shelled, except soybean, A. Toxicological Profile
Subgroup 12–12C; Pome Fruit, Group
subgroup 6C, except cowpea and field EPA has evaluated the available 11–10; Small Vine Climbing Fruit,
pea at 0.05 ppm; pea and bean, toxicity data and considered its validity, Except Grape, Subgroup 13–07E;
succulent shelled, subgroup 6B, except completeness, and reliability as well as Succulent Shelled Pea and Bean,
cowpea at 0.04 ppm; peach subgroup the relationship of the results of the Subgroup 6B; as well as Livestock
12–12B at 3.0 ppm; plum, prune, dried studies to human risk. EPA has also Commodities; in Addition to Uses on
at 3.5 ppm; plum subgroup 12–12C at considered available information Ornamental Plants (including
0.8 ppm; sheep, fat at 0.01 ppm; sheep, concerning the variability of the Residential Use Sites). pages 12–18 in
meat byproducts at 0.01 ppm; and sensitivities of major identifiable docket ID number EPA–HQ–OPP–2016–
vegetable, legume, edible podded, subgroups of consumers, including 0263.
subgroup 6A at 1.5 ppm. That document infants and children. The toxicology
database is complete for isofetamid. In B. Toxicological Points of Departure/
referenced a summary of the petition
repeated dose studies, the liver was the Levels of Concern
prepared by ISK Biosciences
Corporation, the registrant, which is primary target organ in the rat, mouse, Once a pesticide’s toxicological
available in the docket, http:// and dog, as indicated by increased liver profile is determined, EPA identifies
www.regulations.gov. There were no weights, changes in the clinical toxicological points of departure (POD)
comments received in response to the chemistry values, and liver and levels of concern to use in
notice of filing. hypertrophy. A second target organ was evaluating the risk posed by human
Based upon review of the data the thyroid in the rat and dog, as exposure to the pesticide. For hazards
supporting the petition, EPA has revised indicated by changes in thyroid weights that have a threshold below which there
some of the proposed tolerances; and histopathology. Adrenal weight is no appreciable risk, the toxicological
determined that tolerances for residues changes were observed in the POD is used as the basis for derivation
in livestock commodities are not subchronic rat and dog studies. In the of reference values for risk assessment.
required; and corrected some of the rat and dog, the dose levels where PODs are developed based on a careful
commodity definitions. The reason for toxicity was observed were similar or analysis of the doses in each
these changes are explained in Unit higher in the chronic studies compared toxicological study to determine the
IV.D. with the respective subchronic studies, dose at which no adverse effects are
showing an absence of progression of observed (the NOAEL) and the lowest
III. Aggregate Risk Assessment and liver toxicity with time. There was no dose at which adverse effects of concern
Determination of Safety evidence of carcinogenicity in the rat or are identified (the LOAEL). Uncertainty/
Section 408(b)(2)(A)(i) of FFDCA mouse cancer studies; the mutagenicity safety factors are used in conjunction
mstockstill on DSK30JT082PROD with RULES
allows EPA to establish a tolerance (the battery was negative. There are no with the POD to calculate a safe
legal limit for a pesticide chemical genotoxicity, neurotoxicity, or exposure level—generally referred to as
residue in or on a food) only if EPA immunotoxicity concerns observed in a population-adjusted dose (PAD) or a
determines that the tolerance is ‘‘safe.’’ the available toxicity studies. reference dose (RfD)—and a safe margin
Section 408(b)(2)(A)(ii) of FFDCA Developmental toxicity was not of exposure (MOE). For non-threshold
defines ‘‘safe’’ to mean that ‘‘there is a observed in the rat or rabbit, and risks, the Agency assumes that any
reasonable certainty that no harm will offspring effects such as decreased body amount of exposure will lead to some
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![27154 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations
and pests, Reporting and recordkeeping (b) Section 18 emergency exemptions. ADDRESSES: EPA has established a
requirements. [Reserved] docket for this action under Docket ID
Dated: May 4, 2017. * * * * * No. EPA–HQ–OW–2014–0693. All
Michael Goodis, [FR Doc. 2017–12346 Filed 6–13–17; 8:45 am]
documents in the docket are listed on
the https://www.regulations.gov Web
Director, Registration Division, Office of BILLING CODE 6560–50–P
Pesticide Programs.
site. Although listed in the index, some
information is not publicly available,
Therefore, 40 CFR chapter I is e.g., CBI or other information whose
ENVIRONMENTAL PROTECTION
amended as follows: disclosure is restricted by statute.
AGENCY
Certain other material, such as
PART 180—[AMENDED] copyrighted material, is not placed on
40 CFR Part 441
the Internet and will be publicly
■ 1. The authority citation for part 180 [EPA–HQ–OW–2014–0693; FRL–9957–10–
available only in hard copy form. This
continues to read as follows: OW]
material can be viewed at the Water
Authority: 21 U.S.C. 321(q), 346a and 371. RIN 2040–AF26 Docket in the EPA Docket Center, EPA/
■ 2. Section 180.681 is amended as DC, EPA West William Jefferson Clinton
Effluent Limitations Guidelines and Bldg., Room 3334, 1301 Constitution
follows:
Standards for the Dental Category Ave. NW., Washington, DC. The Public
■ a. In the table in paragraph (a)
alphabetically add the following AGENCY: Environmental Protection Reading Room is open from 8:30 a.m. to
commodities: ‘‘Apple, wet pomace’’; Agency (EPA). 4:30 p.m., Monday through Friday,
‘‘Bushberry subgroup 13–07B’’; ACTION: Final rule.
excluding legal holidays. The telephone
‘‘Caneberry subgroup 13–07A’’; ‘‘Cherry number for the Public Reading room is
subgroup 12–12A’’; ‘‘Fruit, pome, group SUMMARY: The Environmental Protection 202–566–1744, and the telephone
11–10’’; ‘‘Fruit, small vine climbing, Agency (EPA) is promulgating number for the Water Docket is 202–
except grape, subgroup 13–07E’’; ‘‘Pea technology-based pretreatment 566–2426. Publicly available docket
and bean, dried shelled, except soybean, standards under the Clean Water Act to materials are available electronically
subgroup 6C’’; ‘‘Pea and bean, succulent reduce discharges of mercury from through http://www.regulations.gov. A
shelled, subgroup 6B’’; ‘‘Peach subgroup dental offices into municipal sewage detailed record index, organized by
12–12B’’; ‘‘Plum, Prune, Dried’’; ‘‘Plum treatment plants known as publicly subject, is available on EPA’s Web site
subgroup 12–12C’’; ‘‘Vegetable, legume, owned treatment works (POTWs). This at https://www.epa.gov/eg/dental-
edible podded, subgroup 6A’’. final rule requires dental offices to use effluent-guidelines .
■ b. Paragraph (b) is revised. amalgam separators and two best FOR FURTHER INFORMATION CONTACT: For
The additions and revision read as management practices recommended by more information, see EPA’s Web site:
follows: the American Dental Association (ADA). https://www.epa.gov/eg/dental-effluent-
This final rule includes a provision to guidelines. For technical information,
§ 180.681 Isofetamid; tolerances for significantly reduce and streamline the contact Ms. Karen Milam, Engineering
residues. oversight and reporting requirements in and Analysis Division (4303T), Office of
(a) * * * EPA’s General Pretreatment Regulations Water, Environmental Protection
that would otherwise apply as a result Agency, 1200 Pennsylvania Ave. NW.,
Parts per of this rulemaking. EPA expects Washington, DC 20460–0001; telephone:
Commodity million compliance with this final rule will 202–566–1915; email: milam.karen@
annually reduce the discharge of epa.gov.
* * * * * mercury by 5.1 tons as well as 5.3 tons
SUPPLEMENTARY INFORMATION:
Apple, wet pomace ................... 2.0 of other metals found in waste dental
Bushberry subgroup 13–07B .... 5.0 amalgam to POTWs. I. Regulated Entities and Supporting
Caneberry subgroup 13–07A ... 4.0 Information
DATES: The final rule is effective on July
A. Regulated Entities
14, 2017. The compliance date, meaning B. Supporting Information
* * * * * the date that existing sources subject to
Cherry subgroup 12–12A ......... 4.0 II. Legal Authority
the rule must comply with the standards III. Executive Summary
* * * * * in this rule is July 14, 2020. After the IV. Background
Fruit, pome, group 11–10 ......... 0.60 effective date of the rule, new sources A. Legal Framework
subject to this rule must comply 1. Clean Water Act
* * * * * immediately with the standards in this 2. Effluent Limitations Guidelines and
Fruit, small vine climbing, ex- rule. In accordance with 40 CFR part 23, Standards
cept grape, subgroup 13–07E 10.0 a. Best Available Technology Economically
this regulation shall be considered Achievable (BAT)
issued for purposes of judicial review at b. Best Available Demonstrated Control
* * * * * 1 p.m. Eastern time on June 28, 2017.
Pea and bean, dried shelled, Technology (BADCT)/New Source
except soybean, subgroup
Under section 509(b)(1) of the CWA, Performance Standards (NSPS)
6C .......................................... 0.040 judicial review of this regulation can be c. Pretreatment Standards for Existing
Pea and bean, succulent had only by filing a petition for review Sources (PSES)
shelled, subgroup 6B ............ 0.030 in the U.S. Court of Appeals within 120 d. Pretreatment Standards for New Sources
(PSNS)
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Peach subgroup 12–12B .......... 3.0 days after the regulation is considered
Plum, Prune, Dried ................... 1.50 issued for purposes of judicial review. e. Best Management Practices (BMPs)
Plum subgroup 12–12C ............ 0.80 B. Dental Sector Rulemaking History and
Under section 509(b)(2), the Summary of Public Comments
requirements in this regulation may not C. Existing State and Local Program
* * * * * be challenged later in civil or criminal
Vegetable, legume, edible pod- Requirements
ded, subgroup 6A ................. 1.50
proceedings brought by EPA to enforce D. Roles and Responsibilities Under the
these requirements. National Pretreatment Program
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Document Created: 2017-06-14 01:24:12
Document Modified: 2017-06-14 01:24:12
| 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 June 14, 2017. Objections and requests for hearings must be received on or before August 14, 2017, 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 L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- | |
| FR Citation | 82 FR 27149 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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