83 FR 5312 - Fomesafen; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 26 (February 7, 2018)
Federal Register Volume 83, Issue 26 (February 7, 2018)
| Page Range | 5312-5317 | |
| FR Document | 2018-02344 |
[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)] [Rules and Regulations] [Pages 5312-5317] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02344] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0629; FRL-9972-66] Fomesafen; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of fomesafen in or on the tuberous and corm vegetable subgroup 1C, the legume vegetable group 6, and the low growing berry subgroup 13-07G (except cranberry). Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 7, 2018. Objections and requests for hearings must be received on or before April 9, 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-2015-0629, 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-2015-0629 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 April 9, 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 [[Page 5313]] notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0629, 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 October 21, 2015 (80 FR 63731) (FRL- 9935-29), 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 5E8395) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR 180.433 be amended by establishing tolerances for residues of fomesafen, 5-[2-cloro-4-(trifluoromethyl)phenoxy]-N- (methylsulfonyl)-2-nitrobenzamide in or on the following raw agricultural commodities: Vegetable, tuberous and corm, subgroup 1C at 0.025 parts per million (ppm); berry, low growing subgroup 13-07G except cranberry at 0.02 ppm; and vegetable, legume group 6 at 0.05 ppm. The petition also requested to amend 40 CFR 180.433 by removing the existing tolerances on the raw agricultural commodities bean, dry at 0.05 ppm; bean, snap, succulent at 0.05 ppm; bean Lima, succulent at 0.05 ppm; pea, succulent at 0.025 ppm; potato at 0.025 ppm; soybean at 0.05 ppm; and soybean, vegetable succulent at 0.05 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, 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. 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 fomesafen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fomesafen follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The primary target organs of fomesafen are the liver and hematological system. Generally, hyalinization of hepatocytes provided the most sensitive toxicological endpoint (intermediate, and long term) in mammals. In the subchronic and chronic toxicity studies in rats and mice, food consumption, food efficiency, body weight, body weight gain, and histopathological changes in the liver were parameters that were most often affected. In addition, dogs, rats, and mice also showed hematological changes (e.g., decreased erythrocyte count, hemoglobin, or hematocrit). No progression of hematological effects was observed beyond 90 days. Neurotoxicity (decreased motor activity) was observed at doses above those causing liver toxicity or impacting hematological parameters. Post-implantation loss was noted in the developmental study, but no quantitative or qualitative evidence of increased susceptibility was seen following in utero exposure to rats or rabbits in developmental studies or in the reproduction study. As the etiology of the post-implantation loss is unknown, it is considered to be both a maternal and fetal endpoint. Fomesafen can result in suppression of anti-SRBC IgM response; however, this immunotoxic potential was noted only at high doses. Carcinogenicity was not observed in the rat chronic toxicity/ carcinogenicity study. Liver tumors were produced in the mouse carcinogenicity study; however, the Agency determined that fomesafen should be classified as ``Not Likely to be Carcinogenic to Humans.'' This decision was based on the weight-of-evidence which supports activation of peroxisome proliferator-activated receptor alpha (PPAR[alpha]) as the mode of action for fomesafen-induced hepatocarcinogenesis in mice. Fomesafen was not considered to be mutagenic. Specific information on the studies received and the nature of the adverse effects caused by fomesafen 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 ``Fomesafen: Draft Human Health Risk Assessment for Registration Review and for the Section 3 Registration Action on Tuberous and Corm Vegetables (Crop Group 1C), Legume Vegetable (Crop Group 6) and Low Growing Berry (Except Cranberry) (Crop Group 13-07G)'' on pages 36-45 in docket ID number EPA-HQ-OPP-2015-0629. 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 [[Page 5314]] 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 fomesafen used for human risk assessment is shown in the Table of this unit. Table--Summary of Toxicological Doses and Endpoints for Fomesafen 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 (Females 13-49 No toxic effects of fomesafen attributable to a single dose and specific to years of age). females of ages 13-49 were found in the database. ---------------------------------------------------------------------------------------------------------------- Acute dietary (General population NOAEL = 100 mg/kg/ Acute RfD = 1 mg/kg/ Acute neurotoxicity test in rats. including infants and children). day. day. LOAEL = 250 mg/kg/day based on UFA = 10x........... aPAD = 1 mg/kg/day. decreased motor activity UFH = 10x........... (horizontal and vertical activity FQPA SF = 1x........ and time in central quadrant) in males. ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL = 1 mg/kg/day. Chronic RfD = 0.01 Subchronic toxicity in the dog. UFA = 10x........... mg/kg/day. LOAEL = 25 mg/kg/day based on UFH = 10x........... cPAD = 0.01 mg/kg/ hematology (decreased hemoglobin FQPA SF = 1x........ day.. and hematocrit concentrations and erythrocyte count and increased platelet count and prothrombin time). ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Classification: The Agency has classified Fomesafen as ``Not Likely to be Carcinogenic to Humans'' ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect- level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fomesafen, EPA considered exposure under the petitioned-for tolerances as well as all existing fomesafen tolerances in 40 CFR 180.433. EPA assessed dietary exposures from fomesafen 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 fomesafen. In estimating acute dietary exposure, EPA used 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA'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 2003-2008 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 fomesafen 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 PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for fomesafen. 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 fomesafen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fomesafen. 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 Pesticide in Water Calculator (PWC) model (Version 1.52) the estimated drinking water concentrations (EDWCs) of fomesafen for acute exposures are estimated to be 168 parts per billion (ppb) and for chronic exposures are estimated to be 125 ppb. These modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. 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). Fomesafen 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 [[Page 5315]] substances that have a common mechanism of toxicity.'' EPA has not found fomesafen to share a common mechanism of toxicity with any other substances, and fomesafen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fomesafen 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 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 is no evidence of increased susceptibility of rat fetuses to in utero exposure to fomesafen. Post-implantation loss was observed in the rat developmental toxicity study. However, as the etiology of the effect is unknown, it is considered to be a part of both a maternal and fetal effect. The 2- generation reproduction study in rats did not show evidence of increased susceptibility to fomesafen. Although the developmental toxicity study in rabbits was classified as unacceptable due to mortality from bacterial infections, there was adequate information to show that there was no evidence of increased susceptibility of rabbit fetuses due to the treatment with fomesafen. 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 toxicology database for fomesafen is complete and sufficient for assessing potential susceptibility to infants and children. Although the developmental toxicity study in rabbits was classified unacceptable due to mortality from bacterial infections, there was no evidence of increased susceptibility of rabbit fetuses due to the treatment with fomesafen. Therefore, the lack of an acceptable developmental toxicity study in non-rodents is not considered a data gap. ii. There is no need for a developmental neurotoxicity study or a need to retain the FQPA SF to account for the lack of such study. Decreased motor activity (horizontal and vertical activity and time in central quadrant) was observed in male rats in the acute neurotoxicity screening battery. In the subchronic neurotoxicity test, neither general systemic toxicity nor neurotoxicity was observed at the highest dose tested. All points of departure used in the risk assessment are protective of potential neurotoxicity. iii. There is no evidence that fomesafen results in increased susceptibility in in utero rats in the prenatal developmental studies or in young rats in the 2-generation reproduction study. Although the developmental toxicity study in rabbits was classified as unacceptable due to mortality from bacterial infections, there was adequate information to show that there was no evidence of increased susceptibility of rabbit fetuses due to the treatment with fomesafen. 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 fomesafen in drinking water. These assessments will not underestimate the exposure and risks posed by fomesafen. 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 fomesafen will occupy 2.9% of the aPAD for all infants less than 1- years 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 fomesafen from food and water will utilize 70% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. There are no residential uses for fomesafen. 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). Both short- and intermediate-term adverse effects were identified; however, fomesafen 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 either short- or intermediate-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 fomesafen. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fomesafen 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 fomesafen residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate residue analytical methods are available for the purpose of fomesafen tolerance enforcement for plant commodities. A high performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS) method (GRM045.01A) has [[Page 5316]] previously been submitted as an enforcement method. The method uses extraction procedures similar to previous methods, SPE cleanup procedures, and the final determination step by LC/MS/MS for analysis of fomesafen residues. The validated limit of quantitation (LOQ) of the method is 0.02 ppm. 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 not established any MRLs for fomesafen. C. Response to Comments Two comments were received in response to the notice of filing. The first was related to a different chemical, azoxystrobin, and is therefore not relevant to this action. The second was from the Center for Biological Diversity and centered primarily around impacts on endangered and threatened species. This comment is not relevant to the Agency's evaluation of safety of the fomesafen tolerances under section 408 of the FFDCA, which requires the Agency to evaluate the potential harms to human health, not effects on the environment. V. Conclusion Therefore, tolerances are established for residues of fomesafen, including its metabolites and degradates, in or on the following commodities: Berry, low growing, subgroup 13-07G, except cranberry at 0.02 ppm; vegetable, legume, group 6 at 0.05 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.025 ppm. In addition, the following existing tolerances are removed as unnecessary since they are superseded by the newly established tolerances: Bean, dry at 0.05 ppm; bean, lima, succulent at 0.05 ppm; bean, snap, succulent at 0.05 ppm; pea, succulent at 0.025 ppm; potato at 0.025 ppm; soybean at 0.05 ppm; and soybean, vegetable, succulent at 0.05 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); 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: January 25, 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. In Sec. 180.433, amend the table in paragraph (a) by: 0 i. Removing the commodities ``Bean, dry''; ``Bean, lima, succulent''; and ``Bean, snap, succulent''; 0 ii. Adding alphabetically the commodity ``Berry, low growing, subgroup 13-07G, except cranberry''; 0 iii. Removing the commodities ``Pea, succulent''; ``Potato''; ``Soybean''; and ``Soybean, vegetable, succulent''; and [[Page 5317]] 0 iv. Adding alphabetically the commodities ``Vegetable, legume, group 6'' and ``Vegetable, tuberous and corm, subgroup 1C''. The additions read as follows: Sec. 180.433 Fomesafen; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Berry, low growing, subgroup 13-07G, except cranberry...... 0.02 * * * * * Vegetable, legume, group 6................................. 0.05 Vegetable, tuberous and corm, subgroup 1C.................. 0.025 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2018-02344 Filed 2-6-18; 8:45 am] BILLING CODE 6560-50-P
![5312 Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Rules and Regulations
have a substantial direct effect on States Parts per Environmental Protection Agency, 1200
Commodity
or tribal governments, on the million Pennsylvania Ave. NW, Washington, DC
relationship between the national 20460–0001; main telephone number:
government and the States or tribal Almond, hulls ........................ 0.40 (703) 305–7090; email address:
governments, or on the distribution of Apple ..................................... 0.01 RDFRNotices@epa.gov.
Bushberry subgroup 13–07B 0.01
power and responsibilities among the Fruit, small, vine climbing, SUPPLEMENTARY INFORMATION:
various levels of government or between except fuzzy kiwifruit, sub-
the Federal Government and Indian I. General Information
group 13–07F .................... 0.01
tribes. Thus, the Agency has determined Nut, tree, group 14–12 ......... 0.02 A. Does this action apply to me?
that Executive Order 13132, entitled
You may be potentially affected by
‘‘Federalism’’ (64 FR 43255, August 10, * * * * *
this action if you are an agricultural
1999) and Executive Order 13175, [FR Doc. 2018–02346 Filed 2–6–18; 8:45 am]
producer, food manufacturer, or
entitled ‘‘Consultation and Coordination BILLING CODE 6560–50–P
pesticide manufacturer. The following
with Indian Tribal Governments’’ (65 FR
list of North American Industrial
67249, November 9, 2000) do not apply
ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is
to this action. In addition, this action
AGENCY not intended to be exhaustive, but rather
does not impose any enforceable duty or
provides a guide to help readers
contain any unfunded mandate as
40 CFR Part 180 determine whether this document
described under Title II of the Unfunded
applies to them. Potentially affected
Mandates Reform Act (UMRA) (2 U.S.C. [EPA–HQ–OPP–2015–0629; FRL–9972–66] entities may include:
1501 et seq.).
Fomesafen; Pesticide Tolerances • Crop production (NAICS code 111).
This action does not involve any • Animal production (NAICS code
technical standards that would require AGENCY: Environmental Protection 112).
Agency consideration of voluntary Agency (EPA). • Food manufacturing (NAICS code
consensus standards pursuant to section ACTION: Final rule. 311).
12(d) of the National Technology • Pesticide manufacturing (NAICS
Transfer and Advancement Act SUMMARY: This regulation establishes code 32532).
(NTTAA) (15 U.S.C. 272 note). tolerances for residues of fomesafen in
B. How can I get electronic access to
or on the tuberous and corm vegetable
VII. Congressional Review Act other related information?
subgroup 1C, the legume vegetable
Pursuant to the Congressional Review group 6, and the low growing berry You may access a frequently updated
Act (5 U.S.C. 801 et seq.), EPA will subgroup 13–07G (except cranberry). electronic version of EPA’s tolerance
submit a report containing this rule and Interregional Research Project Number 4 regulations at 40 CFR part 180 through
other required information to the U.S. (IR–4) requested these tolerances under the Government Printing Office’s e-CFR
Senate, the U.S. House of the Federal Food, Drug, and Cosmetic site at http://www.ecfr.gov/cgi-bin/text-
Representatives, and the Comptroller Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
General of the United States prior to DATES: This regulation is effective 40tab_02.tpl.
publication of the rule in the Federal February 7, 2018. Objections and C. How can I file an objection or hearing
Register. This action is not a ‘‘major requests for hearings must be received request?
rule’’ as defined by 5 U.S.C. 804(2). on or before April 9, 2018, and must be
filed in accordance with the instructions Under FFDCA section 408(g), 21
List of Subjects in 40 CFR Part 180 provided in 40 CFR part 178 (see also U.S.C. 346a, any person may file an
Unit I.C. of the SUPPLEMENTARY objection to any aspect of this regulation
Environmental protection, and may also request a hearing on those
Administrative practice and procedure, INFORMATION).
objections. You must file your objection
Agricultural commodities, Pesticides ADDRESSES: The docket for this action, or request a hearing on this regulation
and pests, Reporting and recordkeeping identified by docket identification (ID) in accordance with the instructions
requirements. number EPA–HQ–OPP–2015–0629, is provided in 40 CFR part 178. To ensure
Dated: January 19, 2018. available at http://www.regulations.gov proper receipt by EPA, you must
Donna S. Davis,
or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
Regulatory Public Docket (OPP Docket) OPP–2015–0629 in the subject line on
Acting Director, Registration Division, Office
in the Environmental Protection Agency the first page of your submission. All
of Pesticide Programs.
Docket Center (EPA/DC), West William objections and requests for a hearing
Therefore, 40 CFR chapter I is Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
amended as follows: Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or
20460–0001. The Public Reading Room before April 9, 2018. Addresses for mail
PART 180—[AMENDED] is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and
Monday through Friday, excluding legal hearing requests are provided in 40 CFR
■ 1. The authority citation for part 180 holidays. The telephone number for the 178.25(b).
continues to read as follows: Public Reading Room is (202) 566–1744, In addition to filing an objection or
Authority: 21 U.S.C. 321(q), 346a and 371.
and the telephone number for the OPP hearing request with the Hearing Clerk
sradovich on DSK3GMQ082PROD with RULES
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
■ 2. In § 180.650, revise the table in the visitor instructions and additional submit a copy of the filing (excluding
paragraph (a) to read as follows: information about the docket available any Confidential Business Information
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
§ 180.650 Isoxaben; tolerances for FOR FURTHER INFORMATION CONTACT: Information not marked confidential
residues.
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be
(a) * * * (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
VerDate Sep<11>2014 17:31 Feb 06, 2018 Jkt 244001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\07FER1.SGM 07FER1](https://thefederalregister.org/doc/83_FR_5338/page/1.svg)
![Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Rules and Regulations 5313
notice. Submit the non-CBI copy of your III. Aggregate Risk Assessment and hematocrit). No progression of
objection or hearing request, identified Determination of Safety hematological effects was observed
by docket ID number EPA–HQ–OPP– Section 408(b)(2)(A)(i) of FFDCA beyond 90 days. Neurotoxicity
2015–0629, by one of the following allows EPA to establish a tolerance (the (decreased motor activity) was observed
methods: legal limit for a pesticide chemical at doses above those causing liver
toxicity or impacting hematological
• Federal eRulemaking Portal: http:// residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’ parameters. Post-implantation loss was
www.regulations.gov. Follow the online
Section 408(b)(2)(A)(ii) of FFDCA noted in the developmental study, but
instructions for submitting comments.
no quantitative or qualitative evidence
Do not submit electronically any defines ‘‘safe’’ to mean that ‘‘there is a
of increased susceptibility was seen
information you consider to be CBI or reasonable certainty that no harm will
following in utero exposure to rats or
other information whose disclosure is result from aggregate exposure to the
rabbits in developmental studies or in
restricted by statute. pesticide chemical residue, including
the reproduction study. As the etiology
• Mail: OPP Docket, Environmental all anticipated dietary exposures and all
of the post-implantation loss is
Protection Agency Docket Center (EPA/ other exposures for which there is
unknown, it is considered to be both a
DC), (28221T), 1200 Pennsylvania Ave. reliable information.’’ This includes
maternal and fetal endpoint. Fomesafen
exposure through drinking water and in
NW, Washington, DC 20460–0001. can result in suppression of anti-SRBC
residential settings, but does not include
• Hand Delivery: To make special IgM response; however, this
occupational exposure. Section immunotoxic potential was noted only
arrangements for hand delivery or 408(b)(2)(C) of FFDCA requires EPA to
delivery of boxed information, please at high doses.
give special consideration to exposure Carcinogenicity was not observed in
follow the instructions at http:// of infants and children to the pesticide the rat chronic toxicity/carcinogenicity
www.epa.gov/dockets/contacts.html. chemical residue in establishing a study. Liver tumors were produced in
Additional instructions on tolerance and to ‘‘ensure that there is a the mouse carcinogenicity study;
commenting or visiting the docket, reasonable certainty that no harm will however, the Agency determined that
along with more information about result to infants and children from fomesafen should be classified as ‘‘Not
dockets generally, is available at http:// aggregate exposure to the pesticide Likely to be Carcinogenic to Humans.’’
www.epa.gov/dockets. chemical residue. . . .’’ This decision was based on the weight-
Consistent with FFDCA section of-evidence which supports activation
II. Summary of Petitioned-For 408(b)(2)(D), and the factors specified in of peroxisome proliferator-activated
Tolerance FFDCA section 408(b)(2)(D), EPA has receptor alpha (PPARa) as the mode of
reviewed the available scientific data action for fomesafen-induced
In the Federal Register of October 21,
and other relevant information in hepatocarcinogenesis in mice.
2015 (80 FR 63731) (FRL–9935–29),
support of this action. EPA has Fomesafen was not considered to be
EPA issued a document pursuant to
sufficient data to assess the hazards of mutagenic.
FFDCA section 408(d)(3), 21 U.S.C.
and to make a determination on Specific information on the studies
346a(d)(3), announcing the filing of a aggregate exposure for fomesafen
pesticide petition (PP 5E8395) by received and the nature of the adverse
including exposure resulting from the effects caused by fomesafen as well as
Interregional Research Project Number 4 tolerances established by this action.
(IR–4), 500 College Road East, Suite 201 the no-observed-adverse-effect-level
EPA’s assessment of exposures and risks (NOAEL) and the lowest-observed-
W., Princeton, NJ 08540. The petition associated with fomesafen follows. adverse-effect-level (LOAEL) from the
requested that 40 CFR 180.433 be
A. Toxicological Profile toxicity studies can be found at http://
amended by establishing tolerances for
www.regulations.gov in the document
residues of fomesafen, 5-[2-cloro-4- EPA has evaluated the available titled ‘‘Fomesafen: Draft Human Health
(trifluoromethyl)phenoxy]-N- toxicity data and considered its validity, Risk Assessment for Registration Review
(methylsulfonyl)-2-nitrobenzamide in or completeness, and reliability as well as and for the Section 3 Registration
on the following raw agricultural the relationship of the results of the Action on Tuberous and Corm
commodities: Vegetable, tuberous and studies to human risk. EPA has also Vegetables (Crop Group 1C), Legume
corm, subgroup 1C at 0.025 parts per considered available information Vegetable (Crop Group 6) and Low
million (ppm); berry, low growing concerning the variability of the Growing Berry (Except Cranberry) (Crop
subgroup 13–07G except cranberry at sensitivities of major identifiable Group 13–07G)’’ on pages 36–45 in
0.02 ppm; and vegetable, legume group subgroups of consumers, including docket ID number EPA–HQ–OPP–2015–
6 at 0.05 ppm. The petition also infants and children. 0629.
requested to amend 40 CFR 180.433 by The primary target organs of
removing the existing tolerances on the fomesafen are the liver and B. Toxicological Points of Departure/
raw agricultural commodities bean, dry hematological system. Generally, Levels of Concern
at 0.05 ppm; bean, snap, succulent at hyalinization of hepatocytes provided Once a pesticide’s toxicological
0.05 ppm; bean Lima, succulent at 0.05 the most sensitive toxicological profile is determined, EPA identifies
ppm; pea, succulent at 0.025 ppm; endpoint (intermediate, and long term) toxicological points of departure (POD)
potato at 0.025 ppm; soybean at 0.05 in mammals. In the subchronic and and levels of concern to use in
ppm; and soybean, vegetable succulent chronic toxicity studies in rats and evaluating the risk posed by human
at 0.05 ppm. That document referenced mice, food consumption, food exposure to the pesticide. For hazards
sradovich on DSK3GMQ082PROD with RULES
a summary of the petition prepared by efficiency, body weight, body weight that have a threshold below which there
Syngenta Crop Protection, LLC, the gain, and histopathological changes in is no appreciable risk, the toxicological
registrant, which is available in the the liver were parameters that were POD is used as the basis for derivation
docket, http://www.regulations.gov. most often affected. In addition, dogs, of reference values for risk assessment.
Comments were received on the notice rats, and mice also showed PODs are developed based on a careful
of filing. EPA’s response to these hematological changes (e.g., decreased analysis of the doses in each
comments is discussed in Unit IV.C. erythrocyte count, hemoglobin, or toxicological study to determine the
VerDate Sep<11>2014 17:31 Feb 06, 2018 Jkt 244001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\07FER1.SGM 07FER1](https://thefederalregister.org/doc/83_FR_5338/page/2.svg)
![5316 Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Rules and Regulations
previously been submitted as an vegetable, tuberous and corm, subgroup government and the States or tribal
enforcement method. The method uses 1C at 0.025 ppm. In addition, the governments, or on the distribution of
extraction procedures similar to following existing tolerances are power and responsibilities among the
previous methods, SPE cleanup removed as unnecessary since they are various levels of government or between
procedures, and the final determination superseded by the newly established the Federal Government and Indian
step by LC/MS/MS for analysis of tolerances: Bean, dry at 0.05 ppm; bean, tribes. Thus, the Agency has determined
fomesafen residues. The validated limit lima, succulent at 0.05 ppm; bean, snap, that Executive Order 13132, entitled
of quantitation (LOQ) of the method is succulent at 0.05 ppm; pea, succulent at ‘‘Federalism’’ (64 FR 43255, August 10,
0.02 ppm. 0.025 ppm; potato at 0.025 ppm; 1999) and Executive Order 13175,
The method may be requested from: soybean at 0.05 ppm; and soybean, entitled ‘‘Consultation and Coordination
Chief, Analytical Chemistry Branch, vegetable, succulent at 0.05 ppm. with Indian Tribal Governments’’ (65 FR
Environmental Science Center, 701 67249, November 9, 2000) do not apply
VI. Statutory and Executive Order
Mapes Rd., Ft. Meade, MD 20755–5350; to this action. In addition, this action
Reviews
telephone number: (410) 305–2905; does not impose any enforceable duty or
email address: residuemethods@ This action establishes tolerances contain any unfunded mandate as
epa.gov. under FFDCA section 408(d) in described under Title II of the Unfunded
response to a petition submitted to the Mandates Reform Act (UMRA) (2 U.S.C.
B. International Residue Limits Agency. The Office of Management and 1501 et seq.).
In making its tolerance decisions, EPA Budget (OMB) has exempted these types This action does not involve any
seeks to harmonize U.S. tolerances with of actions from review under Executive technical standards that would require
international standards whenever Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary
possible, consistent with U.S. food Planning and Review’’ (58 FR 51735, consensus standards pursuant to section
safety standards and agricultural October 4, 1993). Because this action 12(d) of the National Technology
practices. EPA considers the has been exempted from review under Transfer and Advancement Act
international maximum residue limits Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note).
(MRLs) established by the Codex not subject to Executive Order 13211,
Alimentarius Commission (Codex), as entitled ‘‘Actions Concerning VII. Congressional Review Act
required by FFDCA section 408(b)(4). Regulations That Significantly Affect Pursuant to the Congressional Review
The Codex Alimentarius is a joint Energy Supply, Distribution, or Use’’ (66 Act (5 U.S.C. 801 et seq.), EPA will
United Nations Food and Agriculture FR 28355, May 22, 2001); Executive submit a report containing this rule and
Organization/World Health Order 13045, entitled ‘‘Protection of other required information to the U.S.
Organization food standards program, Children from Environmental Health
Senate, the U.S. House of
and it is recognized as an international Risks and Safety Risks’’ (62 FR 19885,
Representatives, and the Comptroller
food safety standards-setting April 23, 1997); nor is it considered a
General of the United States prior to
organization in trade agreements to regulatory action under Executive Order
publication of the rule in the Federal
which the United States is a party. EPA 13771, entitled ‘‘Reducing Regulations
Register. This action is not a ‘‘major
may establish a tolerance that is and Controlling Regulatory Costs’’ (82
rule’’ as defined by 5 U.S.C. 804(2).
different from a Codex MRL; however, FR 9339, February 3, 2017). This action
FFDCA section 408(b)(4) requires that does not contain any information List of Subjects in 40 CFR Part 180
EPA explain the reasons for departing collections subject to OMB approval
Environmental protection,
from the Codex level. under the Paperwork Reduction Act
Administrative practice and procedure,
The Codex has not established any (PRA) (44 U.S.C. 3501 et seq.), nor does
Agricultural commodities, Pesticides
MRLs for fomesafen. it require any special considerations
and pests, Reporting and recordkeeping
under Executive Order 12898, entitled
C. Response to Comments requirements.
‘‘Federal Actions to Address
Two comments were received in Environmental Justice in Minority Dated: January 25, 2018.
response to the notice of filing. The first Populations and Low-Income Michael L. Goodis,
was related to a different chemical, Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
azoxystrobin, and is therefore not 1994). Pesticide Programs.
relevant to this action. The second was Since tolerances and exemptions that
Therefore, 40 CFR chapter I is
from the Center for Biological Diversity are established on the basis of a petition
amended as follows:
and centered primarily around impacts under FFDCA section 408(d), such as
on endangered and threatened species. the tolerance in this final rule, do not PART 180—[AMENDED]
This comment is not relevant to the require the issuance of a proposed rule,
Agency’s evaluation of safety of the the requirements of the Regulatory ■ 1. The authority citation for part 180
fomesafen tolerances under section 408 Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
of the FFDCA, which requires the seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
Agency to evaluate the potential harms This action directly regulates growers,
to human health, not effects on the food processors, food handlers, and food ■ 2. In § 180.433, amend the table in
environment. retailers, not States or tribes, nor does paragraph (a) by:
this action alter the relationships or ■ i. Removing the commodities ‘‘Bean,
V. Conclusion distribution of power and dry’’; ‘‘Bean, lima, succulent’’; and
sradovich on DSK3GMQ082PROD with RULES
Therefore, tolerances are established responsibilities established by Congress ‘‘Bean, snap, succulent’’;
for residues of fomesafen, including its in the preemption provisions of FFDCA ■ ii. Adding alphabetically the
metabolites and degradates, in or on the section 408(n)(4). As such, the Agency commodity ‘‘Berry, low growing,
following commodities: Berry, low has determined that this action will not subgroup 13–07G, except cranberry’’;
growing, subgroup 13–07G, except have a substantial direct effect on States ■ iii. Removing the commodities ‘‘Pea,
cranberry at 0.02 ppm; vegetable, or tribal governments, on the succulent’’; ‘‘Potato’’; ‘‘Soybean’’; and
legume, group 6 at 0.05 ppm; and relationship between the national ‘‘Soybean, vegetable, succulent’’; and
VerDate Sep<11>2014 17:31 Feb 06, 2018 Jkt 244001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\07FER1.SGM 07FER1](https://thefederalregister.org/doc/83_FR_5338/page/5.svg)
![Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Rules and Regulations 5317
■ iv. Adding alphabetically the ADDRESSES: The EPA has established a Order 13563: Improving Regulation and
commodities ‘‘Vegetable, legume, group docket for this action under Docket ID Regulatory Review
6’’ and ‘‘Vegetable, tuberous and corm, No. EPA–HQ–OLEM–2016–0248. All B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
subgroup 1C’’. documents in the docket are listed on
Costs
The additions read as follows: the https://www.regulations.gov C. Paperwork Reduction Act (PRA)
website. Although listed in the index, D. Regulatory Flexibility Act (RFA)
§ 180.433 Fomesafen; tolerances for some information is not publicly
residues. E. Unfunded Mandates Reform Act
available, e.g., Confidential Business (UMRA)
(a) * * * Information (CBI) or other information F. Executive Order 13132: Federalism
whose disclosure is restricted by statute. G. Executive Order 13175: Consultation
Certain other material, such as and Coordination With Indian Tribal
Governments
copyrighted material, is not placed on
Parts per H. Executive Order 13045: Protection of
Commodity million the internet and will be publicly Children From Environmental Health
available only in hard copy form. Risks and Safety Risks
Publicly available docket materials are I. Executive Order 13211: Actions
* * * * * available either electronically at https:// Concerning Regulations That
Berry, low growing, subgroup www.regulations.gov or in hard copy at Significantly Affect Energy Supply,
13–07G, except cranberry .... 0.02 the RCRA Docket, EPA/DC, EPA West, Distribution, or Use
Room 3334, 1301 Constitution Ave. NW, J. National Technology Transfer and
* * * * * Advancement Act (NTTAA)
Washington, DC. The Public Reading
Vegetable, legume, group 6 ..... 0.05 K. Executive Order 12898: Federal Actions
Vegetable, tuberous and corm,
Room is open from 8:30 a.m. to 4:30 To Address Environmental Justice in
subgroup 1C ......................... 0.025 p.m. Monday through Friday, excluding Minority Populations and Low-Income
legal holidays. The telephone number Populations
* * * * * for the Public Reading Room is (202) L. Congressional Review Act (CRA)
566–1744, and the telephone number for
the RCRA Docket is (202) 566–0270. I. General Information
* * * * *
[FR Doc. 2018–02344 Filed 2–6–18; 8:45 am] FOR FURTHER INFORMATION CONTACT: A. List of abbreviations and acronyms used
BILLING CODE 6560–50–P George Faison, Office of Resource in this final rule
Conservation and Recovery, Materials AWPA American Wood Protection
Recovery and Waste Management Association
ENVIRONMENTAL PROTECTION Division, MC 5303P, Environmental Btu British thermal unit
AGENCY Protection Agency, 1200 Pennsylvania C&D Construction and demolition
CAA Clean Air Act
Ave. NW, Washington, DC 20460;
40 CFR Part 241 CBI Confidential business information
telephone number: (703) 305–7652; CFR Code of Federal Regulations
[EPA–HQ–OLEM–2016–0248; FRL–9969– email: faison.george@epa.gov. CISWI Commercial and Industrial Solid
80–OLEM] SUPPLEMENTARY INFORMATION: The Waste Incinerator
RIN 2050–AG83 following outline is provided to aid in CTRT Creosote-treated railroad ties
locating information in this preamble. EPA U.S. Environmental Protection Agency
FR Federal Register
Additions to List of Categorical Non- I. General Information HAP Hazardous air pollutant
Waste Fuels: Other Treated Railroad A. List of Abbreviations and Acronyms MACT Maximum achievable control
Ties Used in This Final Rule technology
B. What is the statutory authority for this MDL Method detection limit
AGENCY: Environmental Protection final rule? NAICS North American Industrial
Agency (EPA). C. Does this action apply to me?
Classification System
ACTION: Final rule. D. What is the purpose of this final rule?
ND Non-detect
E. Effective Date
NESHAP National emission standards for
SUMMARY: The Environmental Protection II. Background
hazardous air pollutants
A. History of the NHSM Rulemakings
Agency (EPA) is issuing amendments to NHSM Non-hazardous secondary material
B. Background to This Final Rule
the Non-Hazardous Secondary Materials OMB Office of Management and Budget
C. How will EPA make categorical non-
regulations, which generally established OTRT Other Treated Railroad Ties
waste determinations?
standards and procedures for PAH Polycyclic aromatic hydrocarbons
III. Comments on the Proposed Rule and
identifying whether non-hazardous ppm Parts per million
Rationale for Final Decisions
RCRA Resource Conservation and Recovery
secondary materials are solid wastes A. Detailed Description of OTRTs
Act
when used as fuels or ingredients in B. OTRTs Under Current NHSM Rules
RIN Regulatory information number
combustion units. In February 2013, the C. Scope of the Final Categorical Non-
RL Reporting Limits
EPA listed particular non-hazardous Waste Listing for OTRTs
SBA Small Business Administration
D. Rationale for Final Rule
secondary materials as ‘‘categorical non- E. Copper and Borates Literature Review
SO2 Sulfur dioxide
waste fuels’’ provided certain SVOC Semi-volatile organic compound
and Other EPA Program Summary
conditions are met. This final rule adds TCLP Toxicity characteristic leaching
F. Summary of Comments Requested
the following other treated railroad ties procedure
G. Responses to Comments
(OTRT) to the categorical non-waste fuel UPL Upper prediction limit
IV. Effect of This Final Rule on Other
U.S.C. United States Code
sradovich on DSK3GMQ082PROD with RULES
list: Processed creosote-borate, copper Programs
VOC Volatile organic compound
naphthenate and copper naphthenate- V. State Authority
borate treated railroad ties, under A. Relationship to State Programs B. What is the statutory authority for
certain conditions depending on the B. State Adoption of the Rulemaking this final rule?
VI. Costs and Benefits
chemical treatment. VII. Statutory and Executive Order Reviews The EPA is amending 40 CFR 241.4(a)
DATES: This rule is effective February 7, A. Executive Order 12866: Regulatory to list additional non-hazardous
2018. Planning and Review and Executive secondary materials (NHSMs) as
VerDate Sep<11>2014 17:31 Feb 06, 2018 Jkt 244001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\07FER1.SGM 07FER1](https://thefederalregister.org/doc/83_FR_5338/page/6.svg)
Document Created: 2018-10-26 13:55:47
Document Modified: 2018-10-26 13:55:47
| 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 February 7, 2018. Objections and requests for hearings must be received on or before April 9, 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 5312 | |
| 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