Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of nitrapyrin in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project No. 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective August 27, 2019. Objections and requests for hearings must be received on or before October 28, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2018–0095, is available at
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:
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).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing Office's e-CFR site at
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–2018–0095 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 October 28, 2019. 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–2018–0095, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from what the petitioner requested, as authorized under FFDCA section 408(d)(4)(A)(i). EPA's explanation for those variations is contained in Unit IV.D.
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
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.
EPA has evaluated the available toxicity data and considered their 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.
In oral studies, the liver is the target organ for nitrapyrin, and liver effects are evident in all species tested. Clear signs of hepatotoxicity (
Nitrapyrin is not mutagenic or immunotoxic, and no effects were observed in the subchronic dermal toxicity study in rabbits up to the limit dose. Nitrapyrin is classified as having “suggestive” evidence of carcinogenicity, based on liver adenomas and carcinomas in mice. This classification is supported by the following factors: (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 mode of action; and (4) There are adequate data supporting the MOA of mitogenesis through activation CAR nuclear receptors in male mice but not in female mice. In addition, 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. Therefore, 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.
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 are discussed in the final rule published in the
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
A summary of the toxicological endpoints for nitrapyrin used for human risk assessment is discussed in Unit III.B of the final rule published in the
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Such effects were identified for nitrapyrin. In estimating acute dietary 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).
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Based on the Tier II pesticide water calculator (PWC), which incorporates the Pesticide Root Zone Model Ground Water (PRZM GW), 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 for non-cancer assessments 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.
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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 website at
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i. The toxicity database for nitrapyrin is complete.
ii. An acceptable acute neurotoxicity study and an acceptable subchronic neurotoxicity study are available for nitrapyrin. Acutely, nitrapyrin induced tremors and other functional observation battery effects (
iii. There is no evidence that nitrapyrin results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to nitrapyrin in drinking water. These assessments will not underestimate the exposure and risks posed by nitrapyrin.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
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However, nitrapyrin is not registered for, or proposed for, any residential uses. Therefore, because there is no short-term or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for nitrapyrin.
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Adequate enforcement methodology (gas chromatograph/electron capture detector) is available to enforce the tolerance expression. 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.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for nitrapyrin.
EPA is establishing tolerances for residues of nitrapyrin at different levels than requested in the petition for most commodities. For fruit, citrus, group 10–10, dried pulp and fruit, citrus, group 10–10, oil, EPA established the tolerances based on the processing study and highest average field trial residue for the raw agricultural commodity lemon. This leads to higher tolerances (0.5 ppm for fruit, citrus, group 10–10, dried pulp and 2 ppm for fruit, citrus, group 10–10, oil) than those proposed by petitioner (0.094 ppm and 0.37 ppm, respectively). EPA also corrected the commodity names for these commodities.
Based on the residue chemistry data and the Organization for Economic Co-Operation and Development (OECD) tolerance-calculation procedure, EPA is establishing different tolerances for fruit, citrus, group 10–10; leaf petiole vegetable subgroup 22B; vegetable,
In addition, EPA is revising the tolerance expression in § 180.350(a) to correctly identify nitrapyrin as a nitrification inhibitor rather than the current identification as an insecticide. The rest of the tolerance expression remains the same. The revised tolerance expression is:
(a)
Therefore, tolerances are established for residues of nitrapyrin, 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 fruit, citrus, group 10–10 at 0.06 ppm; fruit, citrus, group 10–10, dried pulp at 0.5 ppm; fruit, citrus, group 10–10, oil at 2 ppm; leaf petiole vegetable subgroup 22B at 0.5 ppm; vegetable,
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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances 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
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
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).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The revision and additions read as follows:
(a)