82 FR 56739 - Nitrapyrin; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 229 (November 30, 2017)
Federal Register Volume 82, Issue 229 (November 30, 2017)
| Page Range | 56739-56744 | |
| FR Document | 2017-25829 |
[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)] [Rules and Regulations] [Pages 56739-56744] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25829] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0295; FRL-9967-73] Nitrapyrin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of nitrapyrin in or on almond hulls and the tree nut group 14-12. Dow AgroSciences requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 30, 2017. Objections and requests for hearings must be received on or before January 29, 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-2016-0295, 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: [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-2016-0295 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 29, 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-2016-0295, 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/ [[Page 56740]] 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 July 20, 2016 (81 FR 47150) (FRL-9948- 45), 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 6F8470) by Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR 180.350 be amended by establishing tolerances for residues of the herbicide, nitrapyrin [2- chloro-6-(trichloromethyl) pyridine] and its metabolite, 6- chloropicolinic acid (6-CPA), in or on nut, tree group 14-12 at 0.02 parts per million (ppm) and almond, hulls at 0.07 ppm. That document referenced a summary of the petition prepared by Dow AgroSciences, 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 modified the level at which the tolerance is being established for almond hulls. The reason for this change is explained in Unit IV.C. 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 nitrapyrin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with nitrapyrin 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 liver is the major target organ of nitrapyrin in both subchronic and chronic studies via the oral route; no toxicity was seen in the subchronic dermal study. Effects in the oral studies were generally consistent among the species tested (rat, mouse, rabbit, and dog), progressed with time, and typically included increased liver weights, enlarged livers, and/or hepatocellular hypertrophy. Only increased liver weights in the absence of other toxic effects in the liver were noted in the rabbit; however, by study design no other liver parameters were measured. Although some of the observed liver effects (i.e., increased liver weights and hypertrophy) suggest an adaptive response, pronounced decreases in body weight were evident in mice at higher doses and clear signs of hepatotoxicity (i.e., marked changes in clinical chemistry, indicative of liver toxicity and histopathology, leading to malignant tumor formation in mice) are seen only after prolonged exposure. In the chronic dog study, liver toxicity was indicated by marked changes in clinical chemistry parameters (alkaline phosphatase and cholesterol), increased liver weight, and hypertrophy. In rats, increased liver weights were also associated with clinical chemistry changes and histopathology (vacuolation consistent with fatty changes). By contrast to the other species, liver toxicity in mice progressed from liver weight alterations (associated with histopathological findings of hypertrophy, mitotic figures and necrosis) to significantly increased liver adenomas and non- significantly increased liver carcinomas at >=250 mg/kg/day. Kidney effects (increased kidney weights accompanied by intratubular mineralization and multifocal necrosis of the intratubular epithelium) were observed in male rats only, in both the two generation reproduction study and the chronic toxicity study. These kidney effects are indicative of [alpha]-2u-globulin accumulation with eventual progression to renal tumors. This finding of [alpha]-2u-globulin was confirmed by immunoperoxidase stain in the rat chronic study. The response, which only occurs in male rats, is not relevant to humans. Nitrapyrin did not show qualitative or quantitative susceptibility in the rabbit or rat developmental studies. In the developmental toxicity in the rabbit, an increased incidence of crooked hyoid bones was seen at the highest dose tested (HDT). This effect is considered to be treatment-related but not adverse because it does not affect the health of the animal. In the rat developmental study, delayed ossification and decreased fetal body weight occurred at the same dose as maternal toxicity (reduced body weight/weight gain and reduced food consumption) and are not considered more severe than the maternal effects. Toxic effects in the two generation reproduction study occurred at the same dose in both parental animals and the offspring and included increased liver weights (parental M and F; both generations), enlarged livers in F2 pups (M and F), and hepatic vacuolation consistent with fatty changes in parental and offspring animals (both sexes and both generations). In the acute neurotoxicity study, following a single oral dose of 400 mg/kg nitrapyrin, male and female rats showed slight tremors; females also showed gait incoordination, palpebral closure, and perineal fecal staining accompanied by decreased total motor activity ([ap]40% M & F) and an effect on distribution of motor activity (i.e., characterized as a more rapid decline activity than control in both sexes) on Day 1 only. In the subchronic neurotoxicity study, increased landing foot splay in males and females, and increased motor activity in females (equivocal in males) were observed at the same Lowest Observed Adverse Effect Level (LOAEL) (120 mg/kg/day) as systemic effects (increased liver weights, pale livers and increased liver size) in rats. However, there was no evidence of gross pathology or neuropathology in these studies or in any other study throughout the database. [[Page 56741]] There is also no evidence of immunotoxicity or mutagenicity. The available data on carcinogenicity of nitrapyrin includes reports of multiple tumor types that were reported (renal tumors in male rats, stomach, epididymis, or Harderian gland neoplasms in either male or female mice). Following five peer review meetings to evaluate the carcinogenic potential of nitrapyrin as a nitrification inhibitor, EPA concluded that the reported tumors were either not treatment- related or not relevant for the human risk assessment, with the exception of the mouse liver tumors. At that time, the Agency classified nitrapyrin as ``suggestive evidence of carcinogenic potential''. Following this classification, mode of action (MOA) studies were submitted that suggest that nitrapyrin is a mitogen that induces the male mouse liver tumors through activation of the constitutive androstane receptor (CAR), a nuclear receptor. Since the MOA data were not considered complete (no MOA data on female mice), a final decision on the MOA has not been made. The weight of evidence remains as suggestive of carcinogenicity for the following reasons: 1. Liver tumors were not seen in the 2-year carcinogenicity study in rats. 2. The response is driven by benign adenomas. 3. Mutagenicity was ruled out as a MOA. 4. There are adequate data supporting the MOA of mitogenesis through activation CAR nuclear receptors in male mice. Based on the available information and the fact that the chronic reference dose (0.03 mg/kg/day) is approximately 4000X lower than the dose at which tumors are seen in the female mouse, the Agency concludes that quantification of cancer risk using a non-linear Reference Dose (RfD) approach will be protective of all chronic toxicity. Specific information on the studies received and the nature of the adverse effects caused by nitrapyrin 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 ``Nitrapyrin. Human Health Risk Assessment for Registration Review and New Use on Tree Nuts (Crop Group 14-12)'' in docket ID number EPA-HQ-OPP-2016-0295. 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 nitrapyrin used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Nitrapyrin for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (General population NOAEL = 16 mg/kg/day Acute RfD = 0.16 mg/ Acute neurotoxicity rat study. including infants and children). UFA = 10x........... kg/day. LOAEL = 80 mg/kg, based on UFH = 10x........... aPAD = 0.16 mg/kg/ decreased total motor activity on FQPA SF = 1x........ day. Day 1 in females. ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL = 3 mg/kg/day. Chronic RfD = 0.03 1-year chronic dog study. UFA = 10x........... mg/kg/day. LOAEL = 15 mg/kg/day, based on UFH = 10x........... cPAD = 0.03 mg/kg/ increased absolute and relative FQPA SF = 1x........ day. liver weights, increased clinical chemistry (alkaline phosphatase & cholesterol) and liver hypertrophy in both sexes. ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Nitrapyrin is classified as ``suggestive evidence of carcinogenic potential''. EPA has determined that using the chronic RfD to assess carcinogenic potential will be protective of any potential cancer risk. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect- level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to nitrapyrin, EPA considered exposure under the petitioned- for tolerances as well as all existing nitrapyrin tolerances in 40 CFR 180.350. EPA assessed dietary exposures from nitrapyrin 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 nitrapyrin. In estimating acute dietary [[Page 56742]] exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT). ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues and 100 PCT. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that quantification of cancer risk using a non-linear Reference Dose (RfD) approach adequately accounts for all chronic toxicity, including carcinogenicity that could result from exposure to nitrapyrin. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for nitrapyrin. Tolerance-level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used water exposure models in the dietary exposure analysis and risk assessment for nitrapyrin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of nitrapyrin. 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 Tier II pesticide water calculator (PWC), the estimated drinking water concentrations (EDWCs) of nitrapyrin residues of concern for acute exposures are estimated to be 51 parts per billion (ppb) for surface water and 76 ppb for ground water, and for chronic exposures are estimated to be 15 ppb for surface water and 67 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 76 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 67 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). Nitrapyrin is not registered for any specific use patterns that would result in residential exposure. 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 nitrapyrin to share a common mechanism of toxicity with any other substances, and nitrapyrin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that nitrapyrin 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. Neither quantitative nor qualitative susceptibility was seen in either the rabbit or rat developmental studies or in the two generation reproduction study. In the developmental toxicity in the rabbit, an increased incidence of crooked hyoid bones was seen at the highest dose tested (HDT). This effect is considered to be treatment-related but not adverse. In the rat developmental study, delayed ossification and decreased fetal body weight occurred at the same dose as maternal toxicity. Toxic effects in the two generation reproduction study also occurred at the same dose in both parental animals and the offspring and included increased liver weights (parental M and F; both generations), enlarged livers in F2 pups (M and F), and hepatic vacuolation consistent with fatty changes in parental and offspring animals (both sexes and both generations). Similarly, gross pathological or neuropathological findings in the neurotoxicity studies were negative. 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. This decision is based on the following findings: i. The toxicity database for nitrapyrin is complete. ii. In an acute neurotoxicity study, nitrapyrin induced tremors and other functional observation battery effects, (i.e., slight gait incoordination, palpebral closure and perineal fecal staining) at the high dose (400 mg/kg) only. Decreased motor activity was seen in both sexes at 400 mg/kg and in females at 80 mg/kg. In contrast, increased motor activity was observed in the subchronic neurotoxicity study in female rats but only at high doses (>=500 mg/kg/day). Because (1) there are clear NOAELs/LOAELs in the available studies for these effects and the selected endpoints are protective of the observed effects; (2) there is no corroborating gross pathological or neuropathological findings; and (3) there was no evidence of neurotoxicity in other studies in the database, the Agency's concern for potential neurotoxicity is low. Accordingly, and due to the lack of concerns for increased susceptibility in infants and children, there is no need to require a developmental neurotoxicity to further assess the potential for neurotoxicity in infants and children. iii. There is no evidence that nitrapyrin 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. Effects on the offspring were not adverse or occurred only at the same parental dose. 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 to assess exposure to nitrapyrin in drinking water. The EPA believes that these assessments will not underestimate the exposure and risks posed by nitrapyrin. [[Page 56743]] 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, drinking 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 nitrapyrin will utilize 8.5% of the aPAD for all infants less than 1-year-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 nitrapyrin from food and drinking water will utilize 15% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for nitrapyrin. 3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). However, nitrapyrin is not registered for, or proposed for, any residential uses. Therefore, because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD, no further assessment of short-or intermediate-term risk is necessary for nitrapyrin. 4. 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 nitrapyrin. 5. 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 nitrapyrin residues. IV. Other Considerations A. Analytical Enforcement Methodology Seven analytical methods are available in Volume II of the Pesticide Analytical Manual (PAM II--Pesticide Reg. Sec. 180.350) for tolerance enforcement for nitrapyrin and/or for metabolite 6-CPA. 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 nitrapyrin. C. Revisions to Petitioned-For Tolerances The tolerance being established for almond hulls is different than that proposed by the registrant. This difference is due to EPA using the Organization for Economic Cooperation and Development (OECD) Maximum Residue Limits (MRL) calculation procedures to determine appropriate tolerance levels. The results from the spreadsheet calculator supports a tolerance of 0.06 ppm for almond hulls, rather than 0.07 ppm as proposed. Also, EPA has revised the tolerance expression to clarify (1) that as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of nitrapyrin not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression. V. Conclusion Therefore, tolerances are established for residues of nitrapyrin, including its metabolites and degradates, in or on almond, hulls at 0.06 ppm and the nut, tree, group 14-12 at 0.02 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 [[Page 56744]] 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 27, 2017. Daniel Kenny, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. In Sec. 180.350, paragraph (a): 0 a. Revise the introductory text. 0 b. Add alphabetically entries to the table for ``Almond, hulls''; and ``Nut, tree, group 14-12''. The revision and additions read as follows: Sec. 180.350 Nitrapyrin; tolerances for residues. (a) General. Tolerances are established for residues of the insecticide nitrapyrin, including its metabolites and degradates, in or on the commodities below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of nitrapyrin (2-chloro-6-(trichloromethyl) pyridine) and its 6-CPA (6- chloropicolinic acid) metabolite, calculated as the stoichiometric equivalent of nitrapyrin, in or on the commodity: ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Almond, hulls............................................... 0.06 * * * * * Nut, tree, group 14-12...................................... 0.02 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2017-25829 Filed 11-29-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations 56739
entitled ‘‘Consultation and Coordination * * * * * list of North American Industrial
with Indian Tribal Governments’’ (65 FR [FR Doc. 2017–25832 Filed 11–29–17; 8:45 am] Classification System (NAICS) codes is
67249, November 9, 2000) do not apply BILLING CODE 6560–50–P not intended to be exhaustive, but rather
to this action. In addition, this action provides a guide to help readers
does not impose any enforceable duty or determine whether this document
contain any unfunded mandate as ENVIRONMENTAL PROTECTION applies to them. Potentially affected
described under Title II of the Unfunded AGENCY entities may include:
Mandates Reform Act (UMRA) (2 U.S.C. • Crop production (NAICS code 111).
1501 et seq.). 40 CFR Part 180 • Animal production (NAICS code
This action does not involve any [EPA–HQ–OPP–2016–0295; FRL–9967–73] 112).
technical standards that would require • Food manufacturing (NAICS code
Agency consideration of voluntary Nitrapyrin; Pesticide Tolerances 311).
consensus standards pursuant to section • Pesticide manufacturing (NAICS
AGENCY: Environmental Protection code 32532).
12(d) of the National Technology Agency (EPA).
Transfer and Advancement Act B. How can I get electronic access to
ACTION: Final rule.
(NTTAA) (15 U.S.C. 272 note). other related information?
VII. Congressional Review Act SUMMARY: This regulation establishes You may access a frequently updated
tolerances for residues of nitrapyrin in electronic version of EPA’s tolerance
Pursuant to the Congressional Review or on almond hulls and the tree nut
Act (5 U.S.C. 801 et seq.), EPA will regulations at 40 CFR part 180 through
group 14–12. Dow AgroSciences the Government Printing Office’s e-CFR
submit a report containing this rule and requested these tolerances under the
other required information to the U.S. site at http://www.ecfr.gov/cgi-bin/text-
Federal Food, Drug, and Cosmetic Act idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Senate, the U.S. House of (FFDCA).
Representatives, and the Comptroller 40tab_02.tpl.
DATES: This regulation is effective
General of the United States prior to C. How can I file an objection or hearing
November 30, 2017. Objections and
publication of the rule in the Federal request?
requests for hearings must be received
Register. This action is not a ‘‘major Under FFDCA section 408(g), 21
on or before January 29, 2018, and must
rule’’ as defined by 5 U.S.C. 804(2). U.S.C. 346a, any person may file an
be filed in accordance with the
List of Subjects in 40 CFR Part 180 instructions provided in 40 CFR part objection to any aspect of this regulation
178 (see also Unit I.C. of the and may also request a hearing on those
Environmental protection,
SUPPLEMENTARY INFORMATION). objections. You must file your objection
Administrative practice and procedure,
ADDRESSES: The docket for this action, or request a hearing on this regulation
Agricultural commodities, Pesticides
identified by docket identification (ID) in accordance with the instructions
and pests, Reporting and recordkeeping
number EPA–HQ–OPP–2016–0295, is provided in 40 CFR part 178. To ensure
requirements.
available at http://www.regulations.gov proper receipt by EPA, you must
Dated: October 5, 2017. or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
Daniel Kenny, Regulatory Public Docket (OPP Docket) OPP–2016–0295 in the subject line on
Acting Director, Registration Division, Office in the Environmental Protection Agency the first page of your submission. All
of Pesticide Programs. Docket Center (EPA/DC), West William objections and requests for a hearing
Therefore, 40 CFR chapter I is Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
amended as follows: Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
20460–0001. The Public Reading Room before January 29, 2018. Addresses for
PART 180—[AMENDED] 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
■ 1. The authority citation for part 180 holidays. The telephone number for the CFR 178.25(b).
continues to read as follows: Public Reading Room is (202) 566–1744, In addition to filing an objection or
Authority: 21 U.S.C. 321(q), 346a and 371. 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
■ 2. In § 180.589, revise the entry for submit a copy of the filing (excluding
the visitor instructions and additional
‘‘Vegetable, legume, edible podded any Confidential Business Information
information about the docket available
subgroup 6A’’ in the table in paragraph (CBI)) for inclusion in the public docket.
at http://www.epa.gov/dockets.
(a)(1) to read as follows: Information not marked confidential
FOR FURTHER INFORMATION CONTACT:
§ 180.589 Boscalid; tolerances for Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be
residues. (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
(a) * * *
Pennsylvania Ave. NW., Washington, objection or hearing request, identified
(1) * * * by docket ID number EPA–HQ–OPP–
DC 20460–0001; main telephone
Parts per number: (703) 305–7090; email address: 2016–0295, by one of the following
Commodity methods:
million RDFRNotices@epa.gov.
• Federal eRulemaking Portal: http://
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online
sradovich on DSK3GMQ082PROD with RULES
* * * * * I. General Information instructions for submitting comments.
Do not submit electronically any
Vegetable, legume, edible pod- A. Does this action apply to me? information you consider to be CBI or
ded subgroup 6A .................... 5.0 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
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
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![56740 Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations
DC), (28221T), 1200 Pennsylvania Ave. aggregate exposure to the pesticide increased liver carcinomas at ≥250 mg/
NW., Washington, DC 20460–0001. chemical residue. . . .’’ kg/day.
• Hand Delivery: To make special Consistent with FFDCA section Kidney effects (increased kidney
arrangements for hand delivery or 408(b)(2)(D), and the factors specified in weights accompanied by intratubular
delivery of boxed information, please FFDCA section 408(b)(2)(D), EPA has mineralization and multifocal necrosis
follow the instructions at http:// reviewed the available scientific data of the intratubular epithelium) were
www.epa.gov/dockets/contacts.html. and other relevant information in observed in male rats only, in both the
Additional instructions on support of this action. EPA has two generation reproduction study and
commenting or visiting the docket, sufficient data to assess the hazards of the chronic toxicity study. These kidney
along with more information about and to make a determination on effects are indicative of a-2u-globulin
dockets generally, is available at http:// aggregate exposure for nitrapyrin accumulation with eventual progression
www.epa.gov/dockets. including exposure resulting from the to renal tumors. This finding of a-2u-
II. Summary of Petitioned-For tolerances established by this action. globulin was confirmed by
Tolerance EPA’s assessment of exposures and risks immunoperoxidase stain in the rat
associated with nitrapyrin follows. chronic study. The response, which
In the Federal Register of July 20, only occurs in male rats, is not relevant
2016 (81 FR 47150) (FRL–9948–45), A. Toxicological Profile
to humans.
EPA issued a document pursuant to EPA has evaluated the available Nitrapyrin did not show qualitative or
FFDCA section 408(d)(3), 21 U.S.C. toxicity data and considered its validity, quantitative susceptibility in the rabbit
346a(d)(3), announcing the filing of a completeness, and reliability as well as or rat developmental studies. In the
pesticide petition (PP 6F8470) by Dow the relationship of the results of the developmental toxicity in the rabbit, an
AgroSciences, 9330 Zionsville Road, studies to human risk. EPA has also increased incidence of crooked hyoid
Indianapolis, IN 46268. The petition considered available information bones was seen at the highest dose
requested that 40 CFR 180.350 be concerning the variability of the tested (HDT). This effect is considered
amended by establishing tolerances for sensitivities of major identifiable to be treatment-related but not adverse
residues of the herbicide, nitrapyrin [2- subgroups of consumers, including because it does not affect the health of
chloro-6-(trichloromethyl) pyridine] and infants and children. the animal. In the rat developmental
its metabolite, 6-chloropicolinic acid (6– The liver is the major target organ of study, delayed ossification and
CPA), in or on nut, tree group 14–12 at nitrapyrin in both subchronic and decreased fetal body weight occurred at
0.02 parts per million (ppm) and chronic studies via the oral route; no the same dose as maternal toxicity
almond, hulls at 0.07 ppm. That toxicity was seen in the subchronic (reduced body weight/weight gain and
document referenced a summary of the dermal study. Effects in the oral studies reduced food consumption) and are not
petition prepared by Dow AgroSciences, were generally consistent among the considered more severe than the
the registrant, which is available in the species tested (rat, mouse, rabbit, and maternal effects. Toxic effects in the two
docket, http://www.regulations.gov. dog), progressed with time, and generation reproduction study occurred
There were no comments received in typically included increased liver at the same dose in both parental
response to the notice of filing. weights, enlarged livers, and/or animals and the offspring and included
Based upon review of the data hepatocellular hypertrophy. Only increased liver weights (parental M and
supporting the petition, EPA has increased liver weights in the absence of F; both generations), enlarged livers in
modified the level at which the other toxic effects in the liver were F2 pups (M and F), and hepatic
tolerance is being established for noted in the rabbit; however, by study vacuolation consistent with fatty
almond hulls. The reason for this design no other liver parameters were changes in parental and offspring
change is explained in Unit IV.C. measured. Although some of the animals (both sexes and both
observed liver effects (i.e., increased generations).
III. Aggregate Risk Assessment and liver weights and hypertrophy) suggest In the acute neurotoxicity study,
Determination of Safety an adaptive response, pronounced following a single oral dose of 400 mg/
Section 408(b)(2)(A)(i) of FFDCA decreases in body weight were evident kg nitrapyrin, male and female rats
allows EPA to establish a tolerance (the in mice at higher doses and clear signs showed slight tremors; females also
legal limit for a pesticide chemical of hepatotoxicity (i.e., marked changes showed gait incoordination, palpebral
residue in or on a food) only if EPA in clinical chemistry, indicative of liver closure, and perineal fecal staining
determines that the tolerance is ‘‘safe.’’ toxicity and histopathology, leading to accompanied by decreased total motor
Section 408(b)(2)(A)(ii) of FFDCA malignant tumor formation in mice) are activity (≈40% M & F) and an effect on
defines ‘‘safe’’ to mean that ‘‘there is a seen only after prolonged exposure. In distribution of motor activity (i.e.,
reasonable certainty that no harm will the chronic dog study, liver toxicity was characterized as a more rapid decline
result from aggregate exposure to the indicated by marked changes in clinical activity than control in both sexes) on
pesticide chemical residue, including chemistry parameters (alkaline Day 1 only. In the subchronic
all anticipated dietary exposures and all phosphatase and cholesterol), increased neurotoxicity study, increased landing
other exposures for which there is liver weight, and hypertrophy. In rats, foot splay in males and females, and
reliable information.’’ This includes increased liver weights were also increased motor activity in females
exposure through drinking water and in associated with clinical chemistry (equivocal in males) were observed at
residential settings, but does not include changes and histopathology the same Lowest Observed Adverse
occupational exposure. Section (vacuolation consistent with fatty Effect Level (LOAEL) (120 mg/kg/day)
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408(b)(2)(C) of FFDCA requires EPA to changes). By contrast to the other as systemic effects (increased liver
give special consideration to exposure species, liver toxicity in mice weights, pale livers and increased liver
of infants and children to the pesticide progressed from liver weight alterations size) in rats. However, there was no
chemical residue in establishing a (associated with histopathological evidence of gross pathology or
tolerance and to ‘‘ensure that there is a findings of hypertrophy, mitotic figures neuropathology in these studies or in
reasonable certainty that no harm will and necrosis) to significantly increased any other study throughout the
result to infants and children from liver adenomas and non-significantly database.
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![56744 Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations
described under Title II of the Unfunded Parts per • Hand Delivery: Docket Management
Commodity
Mandates Reform Act (UMRA) (2 U.S.C. millionFacility, Room W12–140 on the ground
1501 et seq.). level of the West Building, U.S.
Almond, hulls .............................. 0.06 Department of Transportation, 1200
This action does not involve any
technical standards that would require New Jersey Avenue SE., Washington,
* * * * *
Agency consideration of voluntary Nut, tree, group 14–12 ............... 0.02
DC, between 9 a.m. and 5 p.m., Monday
consensus standards pursuant to section through Friday, except Federal holidays.
12(d) of the National Technology * * * * * Instructions: All submissions must
Transfer and Advancement Act include the agency name and docket
(NTTAA) (15 U.S.C. 272 note). * * * * * number or Regulatory Identification
[FR Doc. 2017–25829 Filed 11–29–17; 8:45 am] Number (RIN) for this rulemaking
VII. Congressional Review Act BILLING CODE 6560–50–P (2130–AC71). Note that all petitions and
comments received will be posted
Pursuant to the Congressional Review without change to http://
Act (5 U.S.C. 801 et seq.), EPA will www.regulations.gov, including any
submit a report containing this rule and DEPARTMENT OF TRANSPORTATION
personal information provided. Please
other required information to the U.S. see the Privacy Act heading in the
Senate, the U.S. House of Federal Railroad Administration
SUPPLEMENTARY INFORMATION section of
Representatives, and the Comptroller this document for Privacy Act
General of the United States prior to 49 CFR Part 270
information related to any submitted
publication of the rule in the Federal [Docket No. FRA–2011–0060, Notice No. 7] petitions, comments or materials.
Register. This action is not a ‘‘major Docket: For access to the docket to
rule’’ as defined by 5 U.S.C. 804(2). RIN 2130–AC71
read background documents, petitions
List of Subjects in 40 CFR Part 180 System Safety Program for reconsideration, or comments
received, go to http://
Environmental protection, AGENCY: Federal Railroad www.regulations.gov at any time or visit
Administrative practice and procedure, Administration (FRA), Department of the Docket Management Facility, U.S.
Agricultural commodities, Pesticides Transportation. Department of Transportation, 1200
and pests, Reporting and recordkeeping ACTION: Final rule; stay of regulations. New Jersey Avenue SE., Room W12–140
requirements. on the Ground level of the West
SUMMARY: On August 12, 2016, FRA Building, between 9 a.m. and 5 p.m.,
Dated: October 27, 2017.
published a final rule requiring Monday through Friday, except Federal
Daniel Kenny,
commuter and intercity passenger holidays.
Acting Director, Registration Division, Office railroads to develop and implement a
of Pesticide Programs. FOR FURTHER INFORMATION CONTACT:
system safety program (SSP) to improve Elizabeth A. Gross, Trial Attorney, U.S.
Therefore, 40 CFR chapter I is the safety of their operations. On Department of Transportation, Federal
amended as follows: February 10, 2017, FRA stayed the SSP Railroad Administration, Office of Chief
final rule’s requirements until March 21, Counsel; telephone: 202–493–1342;
PART 180—[AMENDED] 2017, and extended the stay until May email: Elizabeth.Gross@dot.gov.
22, 2017, June 5, 2017, and then
SUPPLEMENTARY INFORMATION: On August
■ 1. The authority citation for part 180 December 4, 2017. FRA is issuing this
12, 2016, FRA published a final rule
continues to read as follows: final rule to extend that stay until
requiring commuter and intercity
December 4, 2018.
Authority: 21 U.S.C. 321(q), 346a and 371. passenger railroads to develop and
DATES: Effective November 29, 2017, the implement an SSP to improve the safety
■ 2. In § 180.350, paragraph (a): stay of 49 CFR part 270 is extended of their operations. See 81 FR 53850. On
until December 4, 2018. Petitions for February 10, 2017, FRA stayed the SSP
■ a. Revise the introductory text.
reconsideration must be received on or final rule’s requirements until March 21,
■ b. Add alphabetically entries to the before January 19, 2018. Comments in 2017, consistent with the new
table for ‘‘Almond, hulls’’; and ‘‘Nut, response to petitions for reconsideration Administration’s guidance issued
tree, group 14–12’’. must be received on or before March 5, January 20, 2017, intended to provide
The revision and additions read as 2018. the Administration an adequate
follows: ADDRESSES: Petitions for reconsideration opportunity to review new and pending
and comments on petitions for regulations. See 82 FR 10443 (Feb. 13,
§ 180.350 Nitrapyrin; tolerances for reconsideration: Any petitions for
residues.
2017). To provide additional time for
reconsideration or comments on that review, FRA extended the stay until
(a) General. Tolerances are petitions for reconsideration related to May 22, 2017, June 5, 2017, and then
established for residues of the this Docket No. FRA–2011–0060, Notice December 4, 2017. See 82 FR 14476
insecticide nitrapyrin, including its No. 7, may be submitted by any of the (Mar. 21, 2017), 82 FR 23150 (May 22,
metabolites and degradates, in or on the following methods: 2017), and 82 FR 26359 (June 7, 2017).
commodities below. Compliance with • Web site: The Federal eRulemaking These stays of the rule’s requirements
the tolerance levels specified below is to Portal, www.regulations.gov. Follow the did not affect the SSP final rule’s
sradovich on DSK3GMQ082PROD with RULES
be determined by measuring only the Web site’s online instructions for information protection provisions in 49
sum of nitrapyrin (2-chloro-6- submitting comments. CFR 270.105, which took effect for
(trichloromethyl) pyridine) and its 6– • Fax: 202–493–2251. information a railroad compiles or
CPA (6-chloropicolinic acid) metabolite, • Mail: Docket Management Facility, collects solely for SSP purposes on
calculated as the stoichiometric U.S. Department of Transportation, 1200 August 14, 2017.
equivalent of nitrapyrin, in or on the New Jersey Avenue SE., Room W12– FRA’s review included petitions for
commodity: 140, Washington, DC 20590. reconsideration of the SSP final rule
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Document Created: 2017-11-30 00:35:12
Document Modified: 2017-11-30 00:35:12
| 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 November 30, 2017. Objections and requests for hearings must be received on or before January 29, 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 56739 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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