Chlormequat Chloride; Pesticide Tolerances, 17925-17930 [2018-08695]

Download as PDF Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations June 4, 2010, but no later than August 7, 2013, as such incinerator units are defined in § 60.2875 of 40 CFR part 60. The plan applies only to units not exempt under the conditions of § 60.2555 of that part. § 62.8632 Effective date. The federally enforceable effective date of the amended section 111(d)/129 plan for commercial and industrial solid waste incineration units is May 25, 2018. [FR Doc. 2018–08621 Filed 4–24–18; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2016–0661; FRL–9974–42] Chlormequat Chloride; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of chlormequat chloride in or on multiple commodities which are identified and discussed later in this document. Taminco US LLC, a subsidiary of Eastman Chemical Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective April 25, 2018. Objections and requests for hearings must be received on or before June 25, 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–2016–0661, is available at https://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 https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 (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 https://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–2016–0661 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 June 25, 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 17925 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– 2016–0661, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of February 7, 2017 (82 FR 9555) (FRL–9956–86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8495) by Taminco US LLC, a subsidiary of Eastman Chemical Company, Two Windsor Plaza, Suite 400, 7540 Windsor Dr., Allentown, PA 18195. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the plant regulator chlormequat chloride in or on barley grain at 3 parts per million (ppm); bovine, sheep, goat-fat at 0.06 ppm; bovine, sheep, goat-kidney at 0.5 ppm; bovine, sheep, goat-liver at 0.15 ppm; bovine, sheep, goat-muscle at 0.2 ppm; cattle-milk at 0.5 ppm; eggs at 0.1 ppm; oat grain at 15 ppm; poultryfat at 0.03 ppm; poultry-liver at 0.1 ppm; poultry-muscle at 0.04 ppm; swine-fat at 0.02 ppm; swine-kidney at 0.5 ppm; swine-liver at 0.15 ppm; swine-muscle at 0.2 ppm; and wheat grain at 4 ppm. That document referenced a summary of the petition prepared by Taminco US LLC, the registrant, which is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing. EPA’s response to these comments is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has modified the levels at which some of the tolerances are being established as well as the commodities for which tolerances are being established. The reasons for E:\FR\FM\25APR1.SGM 25APR1 17926 Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations these changes are explained in Unit IV.D. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for chlormequat chloride including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with chlormequat chloride follows. sradovich on DSK3GMQ082PROD with RULES 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. Decreases in body weight and signs of neurotoxicity (e.g. ataxia, salivation, decreased body temperature) were VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 consistently observed in the available oral repeat dosing studies in rats, mice, and dogs. Dogs appear to be the most sensitive species with clinical signs of toxicity (salivation, vomiting, and diarrhea) at 10 mg/kg/day in the chronic dog study. Decreased body weights and/ or decreased food consumption were the only effects observed in the 90-day dietary rat study (190 mg/kg/day), and in the chronic toxicity and carcinogenicity studies in rats (125 mg/ kg/day) and mice (363 mg/kg/day). The prenatal developmental rat study (gavage), however, produced clinical signs such as salivation and chromorhinorrhea, as well as decreased food consumption at 90 mg/kg/day. One or more of these clinical signs were observed in the dams typically within one hour after the single oral dose on gestational day six (GD6). In the prenatal developmental toxicity study in rabbits, there were no adverse effects noted up to the highest dose tested (12 mg/kg/day). In the rat two-generation reproduction study, reproductive and offspring effects occurred at doses higher than those causing parental toxicity. There was no quantitative or qualitative susceptibility observed in the offspring compared to the adult animals in the rat and rabbit developmental studies and the rat twogeneration reproduction study. No systemic toxicity was observed in the 21-day dermal study in rabbits when tested up to the limit dose. Dermal irritation and histopathological lesions of the treated skin (acanthosis, subacute inflammation and edema) was observed at 345 mg/kg/day in female rabbits only. No immunotoxicity study was available; however, no evidence of immunotoxicity was observed in the chlormequat chloride database. Carcinogenicity studies in mice and rats did not demonstrate potential signs of carcinogenicity and chlormequat chloride was non-mutagenic in four genotoxicity studies. Therefore, chlormequat chloride is classified as ‘‘Not Likely to be a Carcinogen to Human’’ based on the lack of evidence of carcinogenicity. Specific information on the studies received and the nature of the adverse PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 effects caused by chlormequat chloride as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document titled ‘‘Chlormequat Chloride. Human-Health Risk Assessment to Support Establishment of a Tolerance Without U.S. Registration on Wheat, Barley, and Oats’’ on pages 20–22 in docket ID number EPA–HQ–OPP–2016– 0661. 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 https:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A summary of the toxicological endpoints for chlormequat chloride used for human risk assessment is shown in Table 1 of this unit. E:\FR\FM\25APR1.SGM 25APR1 Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations 17927 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CHLORMEQUAT CHLORIDE FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/scenario Acute dietary (all populations) .. Chronic dietary (All populations) Cancer (Oral, dermal, inhalation). Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects NOAEL = 100 mg/ kg/day UFA = 10x. UFH = 10x FQPA SF = 1x NOAEL= 5 mg/kg/ day UFA = 10x. UFH = 10x FQPA SF = 1x Acute RfD = 1 mg/ kg/day. aPAD = 1 mg/kg/day Prenatal Developmental-Rat and acute neurotoxicity-rat. 1-Day oral LOAEL 180 mg/kg/day, based on overt toxicity signs (tremors, ataxia) within an hour after a single oral dose in dams (GD 6). Chronic Toxicity—Dog. LOAEL (mg/kg/day): 10 mg/kg/day, based on salivation (1week post-dosing, both sexes), vomiting (females), diarrhea (males), and decreased body weight gain (males). Chronic RfD = 0.05 mg/kg/day. cPAD = 0.05 mg/kg/ day Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ based on the lack of carcinogenic potential in the available studies. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. NOAEL = no-observed-adverse-effectlevel. 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). sradovich on DSK3GMQ082PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to chlormequat chloride, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from chlormequat chloride 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 chlormequat chloride. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture’s 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’s 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 chlormequat chloride does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for chlormequat chloride. Tolerancelevel residues and 100 PCT were assumed for all food commodities. VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for chlormequat chloride in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of chlormequat chloride. A total toxic residue approach that assumes all uncharacterized extractable residues are of equal toxicity to chlormequat chloride was used to estimate exposure. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www2.epa.gov/ pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI– GROW) models, the estimated drinking water concentrations (EDWCs) of chlormequat chloride for acute exposures are estimated to be 2574 parts per billion (ppb) for surface water and 24 ppb for ground water and for chronic exposures are estimated to be 91 ppb for surface water and 24 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 2574 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 91 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, PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 indoor pest control, termiticides, and flea and tick control on pets). Chlormequat chloride 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 chlormequat chloride to share a common mechanism of toxicity with any other substances, and chlormequat chloride does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that chlormequat chloride 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 https:// 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 E:\FR\FM\25APR1.SGM 25APR1 17928 Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There was no quantitative or qualitative susceptibility observed in the offspring compared to the adult animals in the rat and rabbit developmental studies and the rat two-generation reproduction study. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings: i. The toxicity database for chlormequat chloride is complete. ii. Although a subchronic neurotoxicity study is not available, evidence of neurotoxicity was observed in the acute neurotoxicity, developmental rat, two-generation reproduction and chronic dog studies. However, there is a low degree of concern for the potential neurotoxic effects of chlormequat chloride because clear no observed adverse effect levels (NOAELs) were identified for the neurotoxic effects, and the endpoints chosen for risk assessment are protective of any potential neurotoxicity. iii. There is no evidence that chlormequat chloride results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to chlormequat chloride in drinking water. These assessments will not underestimate the exposure and risks posed by chlormequat chloride. 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-, VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to chlormequat chloride will occupy 49% of the aPAD for all infants less than 1year-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 chlormequat chloride from food and water will utilize 86% of the cPAD for children 1– 2 years old, the population group receiving the greatest exposure. There are no residential uses for chlormequat chloride. 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). Short- and intermediate-term adverse effects were identified; however, chlormequat chloride is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- 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 intermediateterm risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for chlormequat chloride. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, chlormequat chloride is not expected to pose a cancer risk to humans. 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 chlormequat chloride residues. PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 IV. Other Considerations A. Analytical Enforcement Methodology Plant: An adequate high performance liquid chromatography method with tandem mass spectrometry detection (HPLC/MS/MS), BASF Method No. 530/0, is available for the determination of residues of chlormequat chloride in/ on plant commodities. The HPLC/MS/ MS method determines residues as the chlormequat cation. The limit of quantitation (LOQ) is 0.05 ppm for plant commodities other than straw and 0.1 ppm for straw. Animal: An adequate LC/MS/MS method, BASF Method No. 397/0 is available for the determination of residues of chlormequat chloride in livestock commodities for enforcement purposes. The LOQ is 0.01 ppm for meat, kidney, fat, milk, and egg, and 0.05 ppm for liver. A method description, method validation data, and an independent laboratory validation have been submitted to support the proposed enforcement method. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has established MRLs for chlormequat chloride in or on the commodities referenced in this document at the same levels as the tolerances established for chlormequat chloride in this rule. E:\FR\FM\25APR1.SGM 25APR1 Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations C. Response to Comments Two comments were received in response to the notice of filing. One noted that ‘‘these are of a highly technical nature and should be written in a format that the layperson can understand.’’ The other comment stated that ‘‘there should not be ANY residue of chlormequat chloride on ANY commodity, ever.’’ The first comment does not materially impact this establishment of these tolerances. Concerning the second comment, although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that these chlormequat chloride tolerances are safe. The commenter has provided no information supporting a contrary conclusion. D. Revisions to Petitioned-For Tolerances The petitioner requested tolerances for several animal commodities in addition to the barley, oat, and wheat grain tolerances. The Agency has determined that tolerances are only needed on meat and meat byproducts to cover the liver and kidney tissues. In addition, based on residue data and using the Organisation for Economic Cooperation and Development calculator, the Agency is establishing tolerances for the barley, oat, and wheat grain commodities at levels that harmonize with Codex MRLs. In addition, EPA is revising the commodity terminology used by the petitioner to be consistent with the commodity vocabulary EPA uses for establishing tolerances. sradovich on DSK3GMQ082PROD with RULES V. Conclusion Therefore, tolerances are established for residues of chlormequat chloride, in or on barley, grain at 2.0 ppm; cattle, meat byproduct at 0.50 ppm; cattle, meat at 0.20 ppm; egg at 0.10 ppm; goat, meat byproduct at 0.50 ppm; goat, meat at 0.20 ppm; hog, meat byproduct at 0.50 ppm; hog, meat at 0.20 ppm; milk at 0.50 ppm; oat, grain at 10 ppm; poultry, meat byproduct at 0.10 ppm; poultry, meat at 0.04 ppm; sheep, meat byproduct at 0.50 ppm; sheep, meat at 0.20 ppm; and wheat, grain at 3.0 ppm. VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 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), 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 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 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 17929 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 6, 2018, Michael L. Goodis, 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. Add § 180.698 to subpart C to read as follows: ■ § 180.698 Chlormequat chloride; tolerances for residues. (a) General. Tolerances are established for the residues of the plant regulator chlormequat chloride, including its metabolites and degradates in or on food commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only chlormequat chloride [(2-chloroethyl) trimethylammonium chloride in or on the following commodities: Commodity Barley, grain 1 ............................... Cattle, meat byproduct 1 ............... Cattle, meat 1 ................................ Egg 1 ............................................. E:\FR\FM\25APR1.SGM 25APR1 Parts per million 2.0 0.50 0.20 0.10 17930 Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations Parts per million Commodity Goat, meat byproduct 1 ................. Goat, meat 1 .................................. Hog, meat byproduct 1 .................. Hog, meat 1 ................................... Milk 1 ............................................. Oat, grain 1 .................................... Poultry, meat byproduct 1 ............. Poultry, meat 1 .............................. Sheep, meat byproduct 1 .............. Sheep, meat 1 ............................... Wheat, grain 1 ............................... 0.50 0.20 0.50 0.20 0.50 10 0.10 0.04 0.50 0.20 3.0 1 There are no U.S. registrations for this commodity as of April 25, 2018. (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 2018–08695 Filed 4–24–18; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 67 [Docket ID FEMA–2018–0002] Final Flood Elevation Determinations Federal Emergency Management Agency, DHS. ACTION: Final rule. AGENCY: Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 The date of issuance of the Flood Insurance Rate Map (FIRM) showing BFEs and modified BFEs for each community. This date may be obtained by contacting the office where the maps are available for inspection as indicated in the table below. ADDRESSES: The final BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below. FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646–7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Map Information eXchange (FMIX) online at https:// www.floodmaps.fema.gov/fhm/fmx_ main.html. SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification. This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60. Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown. DATES: PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601–612, a regulatory flexibility analysis is not required. Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132. Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR Part 67 Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements. Dated: April 3, 2018. Roy E. Wright, Deputy Associate Administrator for Insurance and Mitigation, Department of Homeland Security, Federal Emergency Management Agency. Accordingly, 44 CFR part 67 is amended as follows: PART 67—[AMENDED] 1. The authority citation for part 67 continues to read as follows: ■ Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. § 67.11 [Amended] 2. The tables published under the authority of § 67.11 are amended as follows: ■ E:\FR\FM\25APR1.SGM 25APR1

Agencies

[Federal Register Volume 83, Number 80 (Wednesday, April 25, 2018)]
[Rules and Regulations]
[Pages 17925-17930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08695]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0661; FRL-9974-42]


Chlormequat Chloride; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
chlormequat chloride in or on multiple commodities which are identified 
and discussed later in this document. Taminco US LLC, a subsidiary of 
Eastman Chemical Company requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 25, 2018. Objections and 
requests for hearings must be received on or before June 25, 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-2016-0661, is available at https://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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://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-2016-0661 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 
June 25, 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-2016-0661, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-
86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6E8495) by Taminco US LLC, a subsidiary of Eastman Chemical Company, 
Two Windsor Plaza, Suite 400, 7540 Windsor Dr., Allentown, PA 18195. 
The petition requested that 40 CFR part 180 be amended by establishing 
tolerances for residues of the plant regulator chlormequat chloride in 
or on barley grain at 3 parts per million (ppm); bovine, sheep, goat-
fat at 0.06 ppm; bovine, sheep, goat-kidney at 0.5 ppm; bovine, sheep, 
goat-liver at 0.15 ppm; bovine, sheep, goat-muscle at 0.2 ppm; cattle-
milk at 0.5 ppm; eggs at 0.1 ppm; oat grain at 15 ppm; poultry-fat at 
0.03 ppm; poultry-liver at 0.1 ppm; poultry-muscle at 0.04 ppm; swine-
fat at 0.02 ppm; swine-kidney at 0.5 ppm; swine-liver at 0.15 ppm; 
swine-muscle at 0.2 ppm; and wheat grain at 4 ppm. That document 
referenced a summary of the petition prepared by Taminco US LLC, the 
registrant, which is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which some of the tolerances are being 
established as well as the commodities for which tolerances are being 
established. The reasons for

[[Page 17926]]

these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for chlormequat chloride including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with chlormequat 
chloride 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.
    Decreases in body weight and signs of neurotoxicity (e.g. ataxia, 
salivation, decreased body temperature) were consistently observed in 
the available oral repeat dosing studies in rats, mice, and dogs. Dogs 
appear to be the most sensitive species with clinical signs of toxicity 
(salivation, vomiting, and diarrhea) at 10 mg/kg/day in the chronic dog 
study. Decreased body weights and/or decreased food consumption were 
the only effects observed in the 90-day dietary rat study (190 mg/kg/
day), and in the chronic toxicity and carcinogenicity studies in rats 
(125 mg/kg/day) and mice (363 mg/kg/day). The prenatal developmental 
rat study (gavage), however, produced clinical signs such as salivation 
and chromorhinorrhea, as well as decreased food consumption at 90 mg/
kg/day. One or more of these clinical signs were observed in the dams 
typically within one hour after the single oral dose on gestational day 
six (GD6). In the prenatal developmental toxicity study in rabbits, 
there were no adverse effects noted up to the highest dose tested (12 
mg/kg/day). In the rat two-generation reproduction study, reproductive 
and offspring effects occurred at doses higher than those causing 
parental toxicity.
    There was no quantitative or qualitative susceptibility observed in 
the offspring compared to the adult animals in the rat and rabbit 
developmental studies and the rat two-generation reproduction study.
    No systemic toxicity was observed in the 21-day dermal study in 
rabbits when tested up to the limit dose. Dermal irritation and 
histopathological lesions of the treated skin (acanthosis, subacute 
inflammation and edema) was observed at 345 mg/kg/day in female rabbits 
only. No immunotoxicity study was available; however, no evidence of 
immunotoxicity was observed in the chlormequat chloride database.
    Carcinogenicity studies in mice and rats did not demonstrate 
potential signs of carcinogenicity and chlormequat chloride was non-
mutagenic in four genotoxicity studies. Therefore, chlormequat chloride 
is classified as ``Not Likely to be a Carcinogen to Human'' based on 
the lack of evidence of carcinogenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by chlormequat chloride 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 https://www.regulations.gov in the document titled ``Chlormequat Chloride. 
Human-Health Risk Assessment to Support Establishment of a Tolerance 
Without U.S. Registration on Wheat, Barley, and Oats'' on pages 20-22 
in docket ID number EPA-HQ-OPP-2016-0661.

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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for chlormequat chloride 
used for human risk assessment is shown in Table 1 of this unit.

[[Page 17927]]



   Table 1--Summary of Toxicological Doses and Endpoints for Chlormequat Chloride 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 (all populations)..  NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Prenatal Developmental-Rat and
                                    day UFA = 10x.        day.                 acute neurotoxicity-rat.
                                   UFH = 10x...........  aPAD = 1 mg/kg/day.  1-Day oral LOAEL 180 mg/kg/day,
                                   FQPA SF = 1x........                        based on overt toxicity signs
                                                                               (tremors, ataxia) within an hour
                                                                               after a single oral dose in dams
                                                                               (GD 6).
Chronic dietary (All populations)  NOAEL= 5 mg/kg/day    Chronic RfD = 0.05   Chronic Toxicity--Dog.
                                    UFA = 10x.            mg/kg/day.          LOAEL (mg/kg/day): 10 mg/kg/day,
                                   UFH = 10x...........  cPAD = 0.05 mg/kg/    based on salivation (1-week post-
                                   FQPA SF = 1x........   day.                 dosing, both sexes), vomiting
                                                                               (females), diarrhea (males), and
                                                                               decreased body weight gain
                                                                               (males).
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not Likely to be Carcinogenic to Humans'' based on the lack
                                    of carcinogenic potential in the available studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. 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 chlormequat chloride, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
chlormequat chloride 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 chlormequat chloride. In 
estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture's 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's 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 chlormequat chloride does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for chlormequat chloride. Tolerance-level residues and 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for chlormequat chloride in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of chlormequat chloride. A total toxic 
residue approach that assumes all uncharacterized extractable residues 
are of equal toxicity to chlormequat chloride was used to estimate 
exposure. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of chlormequat chloride 
for acute exposures are estimated to be 2574 parts per billion (ppb) 
for surface water and 24 ppb for ground water and for chronic exposures 
are estimated to be 91 ppb for surface water and 24 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 2574 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 91 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).
    Chlormequat chloride 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 chlormequat chloride to share a common mechanism 
of toxicity with any other substances, and chlormequat chloride does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that chlormequat chloride 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 
https://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

[[Page 17928]]

margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the Food Quality Protection 
Act Safety Factor (FQPA SF). In applying this provision, EPA either 
retains the default value of 10X, or uses a different additional safety 
factor when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. There was no quantitative or 
qualitative susceptibility observed in the offspring compared to the 
adult animals in the rat and rabbit developmental studies and the rat 
two-generation reproduction study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for chlormequat chloride is complete.
    ii. Although a subchronic neurotoxicity study is not available, 
evidence of neurotoxicity was observed in the acute neurotoxicity, 
developmental rat, two-generation reproduction and chronic dog studies. 
However, there is a low degree of concern for the potential neurotoxic 
effects of chlormequat chloride because clear no observed adverse 
effect levels (NOAELs) were identified for the neurotoxic effects, and 
the endpoints chosen for risk assessment are protective of any 
potential neurotoxicity.
    iii. There is no evidence that chlormequat chloride results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to chlormequat chloride in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
chlormequat chloride.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to chlormequat chloride will occupy 49% 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 
chlormequat chloride from food and water will utilize 86% of the cPAD 
for children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for chlormequat chloride.
    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).
    Short- and intermediate-term adverse effects were identified; 
however, chlormequat chloride is not registered for any use patterns 
that would result in either short- or intermediate-term residential 
exposure. Short- and intermediate-term risk is assessed based on short- 
and intermediate-term residential exposure plus chronic dietary 
exposure. Because there is no short- 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 chlormequat chloride.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, chlormequat chloride is not expected to pose a cancer risk to 
humans.
    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 chlormequat chloride residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Plant: An adequate high performance liquid chromatography method 
with tandem mass spectrometry detection (HPLC/MS/MS), BASF Method No. 
530/0, is available for the determination of residues of chlormequat 
chloride in/on plant commodities. The HPLC/MS/MS method determines 
residues as the chlormequat cation. The limit of quantitation (LOQ) is 
0.05 ppm for plant commodities other than straw and 0.1 ppm for straw.
    Animal: An adequate LC/MS/MS method, BASF Method No. 397/0 is 
available for the determination of residues of chlormequat chloride in 
livestock commodities for enforcement purposes. The LOQ is 0.01 ppm for 
meat, kidney, fat, milk, and egg, and 0.05 ppm for liver. A method 
description, method validation data, and an independent laboratory 
validation have been submitted to support the proposed enforcement 
method.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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 established MRLs for chlormequat chloride in or on 
the commodities referenced in this document at the same levels as the 
tolerances established for chlormequat chloride in this rule.

[[Page 17929]]

C. Response to Comments

    Two comments were received in response to the notice of filing. One 
noted that ``these are of a highly technical nature and should be 
written in a format that the layperson can understand.'' The other 
comment stated that ``there should not be ANY residue of chlormequat 
chloride on ANY commodity, ever.''
    The first comment does not materially impact this establishment of 
these tolerances. Concerning the second comment, although the Agency 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops, the existing legal framework provided by 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) 
authorizes EPA to establish tolerances when it determines that the 
tolerance is safe. Upon consideration of the validity, completeness, 
and reliability of the available data as well as other factors the 
FFDCA requires EPA to consider, EPA has determined that these 
chlormequat chloride tolerances are safe. The commenter has provided no 
information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerances

    The petitioner requested tolerances for several animal commodities 
in addition to the barley, oat, and wheat grain tolerances. The Agency 
has determined that tolerances are only needed on meat and meat 
byproducts to cover the liver and kidney tissues. In addition, based on 
residue data and using the Organisation for Economic Cooperation and 
Development calculator, the Agency is establishing tolerances for the 
barley, oat, and wheat grain commodities at levels that harmonize with 
Codex MRLs. In addition, EPA is revising the commodity terminology used 
by the petitioner to be consistent with the commodity vocabulary EPA 
uses for establishing tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of chlormequat 
chloride, in or on barley, grain at 2.0 ppm; cattle, meat byproduct at 
0.50 ppm; cattle, meat at 0.20 ppm; egg at 0.10 ppm; goat, meat 
byproduct at 0.50 ppm; goat, meat at 0.20 ppm; hog, meat byproduct at 
0.50 ppm; hog, meat at 0.20 ppm; milk at 0.50 ppm; oat, grain at 10 
ppm; poultry, meat byproduct at 0.10 ppm; poultry, meat at 0.04 ppm; 
sheep, meat byproduct at 0.50 ppm; sheep, meat at 0.20 ppm; and wheat, 
grain at 3.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), 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 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 6, 2018,
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Add Sec.  180.698 to subpart C to read as follows:


Sec.  [emsp14]180.698   Chlormequat chloride; tolerances for residues.

    (a) General. Tolerances are established for the residues of the 
plant regulator chlormequat chloride, including its metabolites and 
degradates in or on food commodities in the table below. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only chlormequat chloride [(2-chloroethyl) trimethylammonium 
chloride in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain \1\............................................        2.0
Cattle, meat byproduct \1\...................................       0.50
Cattle, meat \1\.............................................       0.20
Egg \1\......................................................       0.10

[[Page 17930]]

 
Goat, meat byproduct \1\.....................................       0.50
Goat, meat \1\...............................................       0.20
Hog, meat byproduct \1\......................................       0.50
Hog, meat \1\................................................       0.20
Milk \1\.....................................................       0.50
Oat, grain \1\...............................................         10
Poultry, meat byproduct \1\..................................       0.10
Poultry, meat \1\............................................       0.04
Sheep, meat byproduct \1\....................................       0.50
Sheep, meat \1\..............................................       0.20
Wheat, grain \1\.............................................        3.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of April 25,
  2018.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2018-08695 Filed 4-24-18; 8:45 am]
 BILLING CODE 6560-50-P
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