Nitrapyrin; Pesticide Tolerances, 56739-56744 [2017-25829]

Download as PDF Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations 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 SUMMARY: 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 5, 2017. Daniel Kenny, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.589, revise the entry for ‘‘Vegetable, legume, edible podded subgroup 6A’’ in the table in paragraph (a)(1) to read as follows: ■ § 180.589 Boscalid; tolerances for residues. (a) * * * (1) * * * Parts per million sradovich on DSK3GMQ082PROD with RULES Commodity * * * * * Vegetable, legume, edible podded subgroup 6A .................... * * VerDate Sep<11>2014 * * 17:33 Nov 29, 2017 Jkt 244001 * * * BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2016–0295; FRL–9967–73] Nitrapyrin; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: 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: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information 5.0 * * [FR Doc. 2017–25832 Filed 11–29–17; 8:45 am] 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 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 56739 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, 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/ E:\FR\FM\30NOR1.SGM 30NOR1 56740 Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations 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. sradovich on DSK3GMQ082PROD with RULES 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 [2chloro-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 VerDate Sep<11>2014 17:33 Nov 29, 2017 Jkt 244001 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 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 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 a-2u-globulin accumulation with eventual progression to renal tumors. This finding of a-2uglobulin 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 (≈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. E:\FR\FM\30NOR1.SGM 30NOR1 Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations 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-observedadverse-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 56741 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-andassessing-pesticide-risks/assessinghuman-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 and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (General population including infants and children). NOAEL = 16 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Acute RfD = 0.16 mg/kg/day. aPAD = 0.16 mg/kg/ day Acute neurotoxicity rat study. LOAEL = 80 mg/kg, based on decreased total motor activity on Day 1 in females. Chronic dietary (All populations) NOAEL = 3 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.03 mg/kg/day. cPAD = 0.03 mg/kg/ day 1-year chronic dog study. LOAEL = 15 mg/kg/day, based on increased absolute and relative liver weights, increased clinical chemistry (alkaline phosphatase & cholesterol) and liver hypertrophy in both sexes. Exposure/scenario 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. sradovich on DSK3GMQ082PROD with RULES 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 VerDate Sep<11>2014 17:33 Nov 29, 2017 Jkt 244001 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, PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 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 E:\FR\FM\30NOR1.SGM 30NOR1 sradovich on DSK3GMQ082PROD with RULES 56742 Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations 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-scienceand-assessing-pesticide-risks/aboutwater-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 nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, VerDate Sep<11>2014 17:33 Nov 29, 2017 Jkt 244001 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-andassessing-pesticide-risks/cumulativeassessment-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. PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 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. E:\FR\FM\30NOR1.SGM 30NOR1 Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES E. Aggregate Risks and Determination of Safety IV. Other Considerations 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. 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. VerDate Sep<11>2014 17:33 Nov 29, 2017 Jkt 244001 A. Analytical Enforcement Methodology 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. PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 56743 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 E:\FR\FM\30NOR1.SGM 30NOR1 56744 Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Rules and Regulations 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] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.350, paragraph (a): a. Revise the introductory text. ■ b. Add alphabetically entries to the table for ‘‘Almond, hulls’’; and ‘‘Nut, tree, group 14–12’’. The revision and additions read as follows: ■ ■ sradovich on DSK3GMQ082PROD with RULES § 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: VerDate Sep<11>2014 17:33 Nov 29, 2017 Jkt 244001 • Hand Delivery: Docket Management Facility, Room W12–140 on the ground level of the West Building, U.S. Almond, hulls .............................. 0.06 Department of Transportation, 1200 New Jersey Avenue SE., Washington, * * * * * DC, between 9 a.m. and 5 p.m., Monday Nut, tree, group 14–12 ............... 0.02 through Friday, except Federal holidays. Instructions: All submissions must * * * * * include the agency name and docket number or Regulatory Identification * * * * * Number (RIN) for this rulemaking [FR Doc. 2017–25829 Filed 11–29–17; 8:45 am] (2130–AC71). Note that all petitions and BILLING CODE 6560–50–P comments received will be posted without change to http:// www.regulations.gov, including any DEPARTMENT OF TRANSPORTATION personal information provided. Please see the Privacy Act heading in the Federal Railroad Administration SUPPLEMENTARY INFORMATION section of this document for Privacy Act 49 CFR Part 270 information related to any submitted [Docket No. FRA–2011–0060, Notice No. 7] petitions, comments or materials. Docket: For access to the docket to RIN 2130–AC71 read background documents, petitions for reconsideration, or comments System Safety Program received, go to http:// AGENCY: Federal Railroad www.regulations.gov at any time or visit Administration (FRA), Department of the Docket Management Facility, U.S. Transportation. Department of Transportation, 1200 New Jersey Avenue SE., Room W12–140 ACTION: Final rule; stay of regulations. on the Ground level of the West SUMMARY: On August 12, 2016, FRA Building, between 9 a.m. and 5 p.m., published a final rule requiring Monday through Friday, except Federal commuter and intercity passenger holidays. railroads to develop and implement a FOR FURTHER INFORMATION CONTACT: system safety program (SSP) to improve Elizabeth A. Gross, Trial Attorney, U.S. the safety of their operations. On Department of Transportation, Federal February 10, 2017, FRA stayed the SSP Railroad Administration, Office of Chief final rule’s requirements until March 21, Counsel; telephone: 202–493–1342; 2017, and extended the stay until May email: Elizabeth.Gross@dot.gov. 22, 2017, June 5, 2017, and then SUPPLEMENTARY INFORMATION: On August December 4, 2017. FRA is issuing this 12, 2016, FRA published a final rule final rule to extend that stay until requiring commuter and intercity December 4, 2018. passenger railroads to develop and DATES: Effective November 29, 2017, the implement an SSP to improve the safety 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 reconsideration must be received on or final rule’s requirements until March 21, before January 19, 2018. Comments in 2017, consistent with the new response to petitions for reconsideration Administration’s guidance issued must be received on or before March 5, January 20, 2017, intended to provide 2018. the Administration an adequate ADDRESSES: Petitions for reconsideration opportunity to review new and pending and comments on petitions for regulations. See 82 FR 10443 (Feb. 13, reconsideration: Any petitions for 2017). To provide additional time for reconsideration or comments on that review, FRA extended the stay until petitions for reconsideration related to May 22, 2017, June 5, 2017, and then this Docket No. FRA–2011–0060, Notice December 4, 2017. See 82 FR 14476 No. 7, may be submitted by any of the (Mar. 21, 2017), 82 FR 23150 (May 22, following methods: 2017), and 82 FR 26359 (June 7, 2017). • Web site: The Federal eRulemaking These stays of the rule’s requirements Portal, www.regulations.gov. Follow the did not affect the SSP final rule’s Web site’s online instructions for information protection provisions in 49 submitting comments. CFR 270.105, which took effect for • Fax: 202–493–2251. information a railroad compiles or • Mail: Docket Management Facility, collects solely for SSP purposes on U.S. Department of Transportation, 1200 August 14, 2017. New Jersey Avenue SE., Room W12– FRA’s review included petitions for 140, Washington, DC 20590. reconsideration of the SSP final rule PO 00000 Parts per million Commodity Frm 00042 Fmt 4700 Sfmt 4700 E:\FR\FM\30NOR1.SGM 30NOR1

Agencies

[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Rules and Regulations]
[Pages 56739-56744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25829]


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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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure 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