83 FR 17925 - Chlormequat Chloride; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 80 (April 25, 2018)
Federal Register Volume 83, Issue 80 (April 25, 2018)
| Page Range | 17925-17930 | |
| FR Document | 2018-08695 |
[Federal Register Volume 83, Number 80 (Wednesday, April 25, 2018)] [Rules and Regulations] [Pages 17925-17930] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08695] ----------------------------------------------------------------------- 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 http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0661 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: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956- 86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 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, http://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 http://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 http://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 http://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 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 [[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
![Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations 17925
June 4, 2010, but no later than August (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
7, 2013, as such incinerator units are Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
defined in § 60.2875 of 40 CFR part 60. Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified
The plan applies only to units not 20460–0001; main telephone number: by docket ID number EPA–HQ–OPP–
exempt under the conditions of (703) 305–7090; email address: 2016–0661, by one of the following
§ 60.2555 of that part. RDFRNotices@epa.gov. methods:
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
§ 62.8632 Effective date. www.regulations.gov. Follow the online
The federally enforceable effective I. General Information instructions for submitting comments.
date of the amended section 111(d)/129 Do not submit electronically any
A. Does this action apply to me?
plan for commercial and industrial solid information you consider to be CBI or
waste incineration units is May 25, You may be potentially affected by other information whose disclosure is
2018. this action if you are an agricultural restricted by statute.
[FR Doc. 2018–08621 Filed 4–24–18; 8:45 am] producer, food manufacturer, or • Mail: OPP Docket, Environmental
BILLING CODE 6560–50–P
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
Classification System (NAICS) codes is NW, Washington, DC 20460–0001.
ENVIRONMENTAL PROTECTION not intended to be exhaustive, but rather • Hand Delivery: To make special
AGENCY provides a guide to help readers arrangements for hand delivery or
determine whether this document delivery of boxed information, please
40 CFR Part 180 applies to them. Potentially affected follow the instructions at http://
[EPA–HQ–OPP–2016–0661; FRL–9974–42] entities may include: www.epa.gov/dockets/contacts.html.
• Crop production (NAICS code 111). Additional instructions on
Chlormequat Chloride; Pesticide • Animal production (NAICS code commenting or visiting the docket,
Tolerances 112). along with more information about
• Food manufacturing (NAICS code dockets generally, is available at http://
AGENCY: Environmental Protection 311). www.epa.gov/dockets.
Agency (EPA). • Pesticide manufacturing (NAICS
ACTION: Final rule. II. Summary of Petitioned-For
code 32532).
Tolerance
SUMMARY: This regulation establishes B. How can I get electronic access to In the Federal Register of February 7,
tolerances for residues of chlormequat other related information? 2017 (82 FR 9555) (FRL–9956–86), EPA
chloride in or on multiple commodities You may access a frequently updated issued a document pursuant to FFDCA
which are identified and discussed later electronic version of EPA’s tolerance section 408(d)(3), 21 U.S.C. 346a(d)(3),
in this document. Taminco US LLC, a regulations at 40 CFR part 180 through announcing the filing of a pesticide
subsidiary of Eastman Chemical the Government Printing Office’s e-CFR petition (PP 6E8495) by Taminco US
Company requested these tolerances LLC, a subsidiary of Eastman Chemical
site at http://www.ecfr.gov/cgi-bin/text-
under the Federal Food, Drug, and Company, Two Windsor Plaza, Suite
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Cosmetic Act (FFDCA). 400, 7540 Windsor Dr., Allentown, PA
40tab_02.tpl.
DATES: This regulation is effective April 18195. The petition requested that 40
25, 2018. Objections and requests for C. How can I file an objection or hearing CFR part 180 be amended by
hearings must be received on or before request? establishing tolerances for residues of
June 25, 2018, and must be filed in Under FFDCA section 408(g), 21 the plant regulator chlormequat chloride
accordance with the instructions U.S.C. 346a, any person may file an in or on barley grain at 3 parts per
provided in 40 CFR part 178 (see also objection to any aspect of this regulation million (ppm); bovine, sheep, goat-fat at
Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those 0.06 ppm; bovine, sheep, goat-kidney at
INFORMATION). objections. You must file your objection 0.5 ppm; bovine, sheep, goat-liver at
ADDRESSES: The docket for this action, or request a hearing on this regulation 0.15 ppm; bovine, sheep, goat-muscle at
identified by docket identification (ID) in accordance with the instructions 0.2 ppm; cattle-milk at 0.5 ppm; eggs at
number EPA–HQ–OPP–2016–0661, is provided in 40 CFR part 178. To ensure 0.1 ppm; oat grain at 15 ppm; poultry-
available at http://www.regulations.gov proper receipt by EPA, you must fat at 0.03 ppm; poultry-liver at 0.1
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– ppm; poultry-muscle at 0.04 ppm;
Regulatory Public Docket (OPP Docket) OPP–2016–0661 in the subject line on swine-fat at 0.02 ppm; swine-kidney at
in the Environmental Protection Agency the first page of your submission. All 0.5 ppm; swine-liver at 0.15 ppm;
Docket Center (EPA/DC), West William objections and requests for a hearing swine-muscle at 0.2 ppm; and wheat
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be grain at 4 ppm. That document
Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or referenced a summary of the petition
20460–0001. The Public Reading Room before June 25, 2018. Addresses for mail prepared by Taminco US LLC, the
is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and registrant, which is available in the
Monday through Friday, excluding legal hearing requests are provided in 40 CFR docket, http://www.regulations.gov.
holidays. The telephone number for the 178.25(b). Comments were received on the notice
Public Reading Room is (202) 566–1744, In addition to filing an objection or of filing. EPA’s response to these
sradovich on DSK3GMQ082PROD with RULES
and the telephone number for the OPP hearing request with the Hearing Clerk comments is discussed in Unit IV.C.
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please Based upon review of the data
the visitor instructions and additional submit a copy of the filing (excluding supporting the petition, EPA has
information about the docket available any Confidential Business Information modified the levels at which some of the
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. tolerances are being established as well
FOR FURTHER INFORMATION CONTACT: Information not marked confidential as the commodities for which tolerances
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be are being established. The reasons for
VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\25APR1.SGM 25APR1](https://thefederalregister.org/doc/83_FR_18005/page/1.svg)
![Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations 17929
C. Response to Comments VI. Statutory and Executive Order 67249, November 9, 2000) do not apply
Two comments were received in Reviews to this action. In addition, this action
response to the notice of filing. One This action establishes tolerances does not impose any enforceable duty or
noted that ‘‘these are of a highly under FFDCA section 408(d) in contain any unfunded mandate as
technical nature and should be written response to a petition submitted to the described under Title II of the Unfunded
in a format that the layperson can Agency. The Office of Management and Mandates Reform Act (UMRA) (2 U.S.C.
understand.’’ The other comment stated Budget (OMB) has exempted these types 1501 et seq.).
of actions from review under Executive This action does not involve any
that ‘‘there should not be ANY residue
Order 12866, entitled ‘‘Regulatory technical standards that would require
of chlormequat chloride on ANY
Planning and Review’’ (58 FR 51735, Agency consideration of voluntary
commodity, ever.’’
October 4, 1993). Because this action consensus standards pursuant to section
The first comment does not materially
has been exempted from review under 12(d) of the National Technology
impact this establishment of these
Executive Order 12866, this action is Transfer and Advancement Act
tolerances. Concerning the second
not subject to Executive Order 13211, (NTTAA) (15 U.S.C. 272 note).
comment, although the Agency
recognizes that some individuals believe entitled ‘‘Actions Concerning VII. Congressional Review Act
that pesticides should be banned on Regulations That Significantly Affect Pursuant to the Congressional Review
agricultural crops, the existing legal Energy Supply, Distribution, or Use’’ (66 Act (5 U.S.C. 801 et seq.), EPA will
framework provided by section 408 of FR 28355, May 22, 2001) or Executive submit a report containing this rule and
the Federal Food, Drug and Cosmetic Order 13045, entitled ‘‘Protection of other required information to the U.S.
Act (FFDCA) authorizes EPA to Children from Environmental Health Senate, the U.S. House of
establish tolerances when it determines Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller
that the tolerance is safe. Upon April 23, 1997), nor is it considered a General of the United States prior to
consideration of the validity, regulatory action under Executive Order publication of the rule in the Federal
completeness, and reliability of the 13771, entitled ‘‘Reducing Regulations Register. This action is not a ‘‘major
available data as well as other factors and Controlling Regulatory Costs’’ (82 rule’’ as defined by 5 U.S.C. 804(2).
the FFDCA requires EPA to consider, FR 9339, February 3, 2017). This action
EPA has determined that these does not contain any information List of Subjects in 40 CFR Part 180
chlormequat chloride tolerances are collections subject to OMB approval Environmental protection,
safe. The commenter has provided no under the Paperwork Reduction Act Administrative practice and procedure,
information supporting a contrary (PRA) (44 U.S.C. 3501 et seq.), nor does Agricultural commodities, Pesticides
conclusion. it require any special considerations and pests, Reporting and recordkeeping
under Executive Order 12898, entitled requirements.
D. Revisions to Petitioned-For ‘‘Federal Actions to Address
Tolerances Environmental Justice in Minority Dated: April 6, 2018,
The petitioner requested tolerances Populations and Low-Income Michael L. Goodis,
for several animal commodities in Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
addition to the barley, oat, and wheat 1994). Pesticide Programs.
grain tolerances. The Agency has Since tolerances and exemptions that Therefore, 40 CFR chapter I is
determined that tolerances are only are established on the basis of a petition amended as follows:
needed on meat and meat byproducts to under FFDCA section 408(d), such as
cover the liver and kidney tissues. In the tolerance in this final rule, do not PART 180—[AMENDED]
addition, based on residue data and require the issuance of a proposed rule,
■ 1. The authority citation for part 180
using the Organisation for Economic the requirements of the Regulatory
continues to read as follows:
Cooperation and Development Flexibility Act (RFA) (5 U.S.C. 601 et
calculator, the Agency is establishing seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
tolerances for the barley, oat, and wheat This action directly regulates growers, ■ 2. Add § 180.698 to subpart C to read
grain commodities at levels that food processors, food handlers, and food as follows:
harmonize with Codex MRLs. In retailers, not States or tribes, nor does
addition, EPA is revising the commodity this action alter the relationships or § 180.698 Chlormequat chloride;
terminology used by the petitioner to be distribution of power and tolerances for residues.
consistent with the commodity responsibilities established by Congress (a) General. Tolerances are
vocabulary EPA uses for establishing in the preemption provisions of FFDCA established for the residues of the plant
tolerances. section 408(n)(4). As such, the Agency regulator chlormequat chloride,
has determined that this action will not including its metabolites and degradates
V. Conclusion have a substantial direct effect on States in or on food commodities in the table
Therefore, tolerances are established or tribal governments, on the below. Compliance with the tolerance
for residues of chlormequat chloride, in relationship between the national levels specified below is to be
or on barley, grain at 2.0 ppm; cattle, government and the States or tribal determined by measuring only
meat byproduct at 0.50 ppm; cattle, governments, or on the distribution of chlormequat chloride [(2-chloroethyl)
meat at 0.20 ppm; egg at 0.10 ppm; goat, power and responsibilities among the trimethylammonium chloride in or on
meat byproduct at 0.50 ppm; goat, meat various levels of government or between the following commodities:
sradovich on DSK3GMQ082PROD with RULES
at 0.20 ppm; hog, meat byproduct at the Federal Government and Indian
0.50 ppm; hog, meat at 0.20 ppm; milk tribes. Thus, the Agency has determined Parts per
Commodity million
at 0.50 ppm; oat, grain at 10 ppm; that Executive Order 13132, entitled
poultry, meat byproduct at 0.10 ppm; ‘‘Federalism’’ (64 FR 43255, August 10, Barley, grain 1 ............................... 2.0
poultry, meat at 0.04 ppm; sheep, meat 1999) and Executive Order 13175, Cattle, meat byproduct 1 ............... 0.50
byproduct at 0.50 ppm; sheep, meat at entitled ‘‘Consultation and Coordination Cattle, meat 1 ................................ 0.20
0.20 ppm; and wheat, grain at 3.0 ppm. with Indian Tribal Governments’’ (65 FR Egg 1 ............................................. 0.10
VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\25APR1.SGM 25APR1](https://thefederalregister.org/doc/83_FR_18005/page/5.svg)
![17930 Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Rules and Regulations
Parts per DATES: The date of issuance of the Flood National Environmental Policy Act.
Commodity million Insurance Rate Map (FIRM) showing This final rule is categorically excluded
BFEs and modified BFEs for each from the requirements of 44 CFR part
Goat, meat byproduct 1 ................. 0.50 community. This date may be obtained 10, Environmental Consideration. An
Goat, meat 1 .................................. 0.20 by contacting the office where the maps environmental impact assessment has
Hog, meat byproduct 1 .................. 0.50
Hog, meat 1 ................................... 0.20
are available for inspection as indicated not been prepared.
Milk 1 ............................................. 0.50 in the table below. Regulatory Flexibility Act. As flood
Oat, grain 1 .................................... 10 ADDRESSES: The final BFEs for each elevation determinations are not within
Poultry, meat byproduct 1 ............. 0.10 community are available for inspection the scope of the Regulatory Flexibility
Poultry, meat 1 .............................. 0.04 at the office of the Chief Executive Act, 5 U.S.C. 601–612, a regulatory
Sheep, meat byproduct 1 .............. 0.50 Officer of each community. The flexibility analysis is not required.
Sheep, meat 1 ............................... 0.20 respective addresses are listed in the Regulatory Classification. This final
Wheat, grain 1 ............................... 3.0 table below. rule is not a significant regulatory action
1 There are no U.S. registrations for this FOR FURTHER INFORMATION CONTACT: Rick under the criteria of section 3(f) of
commodity as of April 25, 2018. Sacbibit, Chief, Engineering Services Executive Order 12866 of September 30,
(b) Section 18 emergency exemptions. Branch, Federal Insurance and 1993, Regulatory Planning and Review,
[Reserved] Mitigation Administration, FEMA, 400 58 FR 51735.
(c) Tolerances with regional C Street SW, Washington, DC 20472, Executive Order 13132, Federalism.
registrations. [Reserved] (202) 646–7659, or (email) This final rule involves no policies that
(d) Indirect or inadvertent residues. patrick.sacbibit@fema.dhs.gov; or visit have federalism implications under
[Reserved] the FEMA Map Information eXchange Executive Order 13132.
[FR Doc. 2018–08695 Filed 4–24–18; 8:45 am]
(FMIX) online at https:// Executive Order 12988, Civil Justice
www.floodmaps.fema.gov/fhm/fmx_ Reform. This final rule meets the
BILLING CODE 6560–50–P
main.html. applicable standards of Executive Order
SUPPLEMENTARY INFORMATION: The
12988.
DEPARTMENT OF HOMELAND Federal Emergency Management Agency List of Subjects in 44 CFR Part 67
SECURITY (FEMA) makes the final determinations
Administrative practice and
listed below for the modified BFEs for
procedure, Flood insurance, Reporting
Federal Emergency Management each community listed. These modified
and recordkeeping requirements.
Agency elevations have been published in
newspapers of local circulation and Dated: April 3, 2018.
44 CFR Part 67 ninety (90) days have elapsed since that Roy E. Wright,
publication. The Deputy Associate Deputy Associate Administrator for Insurance
[Docket ID FEMA–2018–0002]
Administrator for Mitigation has and Mitigation, Department of Homeland
resolved any appeals resulting from this Security, Federal Emergency Management
Final Flood Elevation Determinations
notification. Agency.
AGENCY: Federal Emergency This final rule is issued in accordance Accordingly, 44 CFR part 67 is
Management Agency, DHS. with section 110 of the Flood Disaster amended as follows:
ACTION: Final rule. Protection Act of 1973, 42 U.S.C. 4104,
and 44 CFR part 67. FEMA has PART 67—[AMENDED]
SUMMARY: Base (1% annual-chance) developed criteria for floodplain
Flood Elevations (BFEs) and modified management in floodprone areas in ■ 1. The authority citation for part 67
BFEs are made final for the accordance with 44 CFR part 60. continues to read as follows:
communities listed below. The BFEs Interested lessees and owners of real Authority: 42 U.S.C. 4001 et seq.;
and modified BFEs are the basis for the property are encouraged to review the Reorganization Plan No. 3 of 1978, 3 CFR,
floodplain management measures that proof Flood Insurance Study and FIRM 1978 Comp., p. 329; E.O. 12127, 44 FR 19367,
each community is required either to available at the address cited below for 3 CFR, 1979 Comp., p. 376.
adopt or to show evidence of being each community. The BFEs and
already in effect in order to qualify or § 67.11 [Amended]
modified BFEs are made final in the
remain qualified for participation in the communities listed below. Elevations at ■ 2. The tables published under the
National Flood Insurance Program selected locations in each community authority of § 67.11 are amended as
(NFIP). are shown. follows:
sradovich on DSK3GMQ082PROD with RULES
VerDate Sep<11>2014 16:26 Apr 24, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\25APR1.SGM 25APR1](https://thefederalregister.org/doc/83_FR_18005/page/6.svg)
Document Created: 2018-11-02 08:17:23
Document Modified: 2018-11-02 08:17:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective 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). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone | |
| FR Citation | 83 FR 17925 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR