83 FR 6975 - Pendimethalin; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 33 (February 16, 2018)
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 6975-6981 | |
| FR Document | 2018-03277 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Rules and Regulations] [Pages 6975-6981] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03277] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0247; FRL-9973-03] Pendimethalin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation amends the tolerances for residues of pendimethalin in or on alfalfa, forage and alfalfa, hay. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 16, 2018. Objections and requests for hearings must be received on or before April 17, 2018, and must be filed in accordance with the instructions provided in 40 CFR part [[Page 6976]] 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-2014-0247, 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 L. Goodis, Director, 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-2014-0247 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 17, 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-2014-0247, 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 August 1, 2014 (79 FR 44729) (FRL-9911- 67), 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 4F8245) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.361 be amended by increasing the tolerances for residues of the herbicide pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on alfalfa, forage to 80 parts per million (ppm) and alfalfa, hay to 150 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket EPA-HQ-OPP-2014-0397 at http://www.regulations.gov. There were no comments received in response to the notice of filing. 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 pendimethalin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pendimethalin 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 target organ for pendimethalin is the thyroid. Thyroid toxicity in chronic and subchronic rat and mouse studies was manifested as alterations in thyroid hormones (decreased total T4 and T3, [[Page 6977]] increased percent of free T4 and T3), increased thyroid weight, and microscopic thyroid lesions (including increased thyroid follicular cell height, follicular cell hyperplasia, as well as follicular cell adenomas). Due to these effects, the Agency required that a developmental thyroid assay be conducted to evaluate the impact of pendimethalin on thyroid hormones, structure, and/or thyroid hormone homeostasis during development. A developmental thyroid study was submitted and demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin. There is no evidence that pendimethalin is a developmental, reproductive, neurotoxic, or immunotoxic chemical. There is no evidence of increased qualitative or quantitative susceptibility in the young. EPA classified pendimethalin as a ``Group C'', possible human carcinogen based on a statistically significant increased trend and pair-wise comparison between the high-dose group and controls for thyroid follicular cell adenomas in male and female rats. A non- quantitative approach (i.e., non-linear, reference dose (RfD) approach) was used to assess cancer risk since mode-of-action studies are available to demonstrate that the thyroid tumors are due to a thyroid- pituitary imbalance, and also since pendimethalin was shown to be non- mutagenic in mammalian somatic cells and germ cells. Specific information on the studies received and the nature of the adverse effects caused by pendimethalin as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of December 21, 2015 (80 FR 79267) (FRL-9937-18). 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 pendimethalin used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Pendimethalin for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (General population NOAEL = 100 mg/kg/ Acute RfD = 1 mg/kg/ Acute neurotoxicity study. including infants and children). day. day. LOAEL = 300 mg/kg/day based on UFA = 10x........... aPAD = 1 mg/kg/day. reduced motor activity for males UFH = 10x........... and females on Day 0. FQPA SF = 1x........ Chronic dietary (All populations) NOAEL= 10 mg/kg/day. Chronic RfD = 0.3 92-Day thyroid function study in UFA = 3x............ mg/kg/day. rats; 56-day thyroid study in UFH = 10x........... cPAD = 0.3 mg/kg/ rats; 14-day intra thyroid FQPA SF = 1x........ day. metabolism study in rats. LOAEL = 31 mg/kg/day based on hormonal and histopathological changes in the thyroid. Incidental oral short-term (1 to NOAEL= 10 mg/kg/day. LOC for MOE = 30... 92-Day thyroid function study in 30 days). UFA = 3x............ rats; 56-day thyroid study in UFH = 10x........... rats; 14-day intra thyroid FQPA SF = 1x........ metabolism study in rats. LOAEL = 31 mg/kg/day based on hormonal and histopathological changes in the thyroid. Dermal short-term (1 to 30 days). Dermal (or oral) LOC for MOE = 30... 92-Day thyroid function study in study NOAEL = 10 mg/ rats; 56-day thyroid study in kg/day (dermal rats; 14-day intra thyroid absorption rate = metabolism study in rats. 3%. LOAEL = 31 mg/kg/day based on UFA = 3x............ hormonal and histopathological UFH = 10x........... changes in the thyroid. FQPA SF = 1x........ Dermal intermediate-term (1 to 6 Dermal (or oral) LOC for MOE = 30... 92-Day thyroid function study in months). study NOAEL = 10 mg/ rats; 56-day thyroid study in kg/day (dermal rats; 14-day intra thyroid absorption rate = metabolism study in rats. 3%. LOAEL = 31 mg/kg/day based on UFA = 3x............ hormonal and histopathological UFH = 10x........... changes in the thyroid. FQPA SF = 1x........ [[Page 6978]] Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 30... 92-Day thyroid function study in days). study NOAEL= 10 mg/ rats; 56-day thyroid study in kg/day (inhalation rats; 14-day intra thyroid absorption rate = metabolism study in rats. 100%). LOAEL = 31 mg/kg/day based on UFA = 3x............ hormonal and histopathological UFH = 10x........... changes in the thyroid. FQPA SF = 1x........ Inhalation (1 to 6 months)....... Inhalation (or oral) LOC for MOE = 30... 92-Day thyroid function study in study NOAEL= 10 mg/ rats; 56-day thyroid study in kg/day (inhalation rats; 14-day intra thyroid absorption rate = metabolism study in rats. 100%). LOAEL = 31 mg/kg/day based on UFA = 3x............ hormonal and histopathological UFH = 10x........... changes in the thyroid. FQPA SF = 1x........ Cancer (Oral, dermal, inhalation) Group C, possible human carcinogen based on a statistically significant increased trend and pair-wise comparison between the high dose group and controls for thyroid follicular cell adenomas in male and female rats. The chronic RfD will be protective of cancer effects. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. LOAEL = lowest 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). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pendimethalin, EPA considered exposure under the petitioned-for tolerances as well as all existing pendimethalin tolerances in 40 CFR 180.361. EPA assessed dietary exposures from pendimethalin 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 pendimethalin. In estimating acute dietary exposure, EPA Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 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 used tolerance-level residues, and 100 percent crop treated (PCT) for all commodities. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level residues, and 100 PCT for all commodities. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to pendimethalin. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for pendimethalin. Tolerance-level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. In drinking water, the residue of concern is pendimethalin, parent only. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for pendimethalin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pendimethalin. 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 Root Zone Model Ground Water (PRZM GW) and [[Page 6979]] Surface Water Concentration Calculator (SWCC) models, the estimated drinking water concentrations (EDWCs) of pendimethalin for acute exposures are estimated to be 96.4 parts per billion (ppb) for surface water and 4.38 x 10\-9\ ppb for ground water. For chronic exposures for non-cancer assessments, they are estimated to be 9.73 ppb for surface water. For acute dietary risk assessment, the water concentration value of 96.4 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 9.73 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). Pendimethalin is currently registered for the following uses that could result in residential exposures: Turf, home gardens, and ornamentals. EPA assessed residential exposure using the following assumptions: For handlers, it is assumed that residential use will result in short-term (1 to 30 days) duration dermal and inhalation exposures. Residential post-application exposure is also assumed to be short-term (1-30 days) in duration, resulting from the following exposure scenarios: Gardening: Adults (dermal) and children 6 < 11 years old (dermal); Physical activities on turf: Adults (dermal) and children 1-2 years old (dermal and incidental oral); Mowing turf: Adults (dermal) and children 11 < 16 years old (dermal); and Exposure to golf courses during golfing: Adults (dermal), children 11 < 16 years old (dermal), and children 6 < 11 years old (dermal). EPA did not combine exposure resulting from adult handler and post- application exposure resulting from treated gardens, lawns, and/or golfing because the conservative assumptions and inputs within each estimated exposure scenario would result in an overestimate of adult exposure. EPA selected the most conservative adult residential scenario (adult dermal post-application exposure from gardening) as the contributing source of residential exposure to be combined with the dietary exposure for the aggregate assessment. The children's oral exposure is based on post-application hand-to-mouth exposures. To include exposure from object-to-mouth and soil ingestion in addition to hand-to-mouth would overestimate the potential for oral exposure. However, there is the potential for co-occurrence of dermal and oral exposure, since the toxicological effects from the dermal and oral routes of exposure are the same. As a result, the children's aggregate assessment combines post-application dermal and oral exposure along with dietary exposure from food and water. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 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 pendimethalin to share a common mechanism of toxicity with any other substances, and pendimethalin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pendimethalin 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 FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There was no indication of pre- and/or post-natal qualitative or quantitative increased susceptibility in the developmental studies in rats and rabbits or the 2-generation reproduction studies in rats. A developmental thyroid toxicity study demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin. 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 pendimethalin is complete. Although a subchronic inhalation study was not available in the database, EPA determined that one is not needed at this time based on a weight-of- evidence analysis, considering the following: (1) All relevant hazard and exposure information, which indicates its low acute inhalation toxicity; (2) its physical/chemical properties, which indicate its low volatility; and (3) the use of an oral POD that results in a residential inhalation margin of exposure (MOE) more than 10X the level of concern (in the case of pendimethalin MOE = 30 based on thyroid POD). ii. There is no indication that pendimethalin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that pendimethalin 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. In addition, a developmental thyroid toxicity study demonstrated that there is no potential thyroid toxicity following pre- and/or post- natal exposure to pendimethalin. 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 pendimethalin in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pendimethalin. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are [[Page 6980]] 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 pendimethalin will occupy 2% 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 pendimethalin from food and water will utilize 2.4% of the cPAD for children one to two years old the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pendimethalin is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pendimethalin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pendimethalin. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 130 for adults and 92 for children 1-2 years old, the two population subgroups receiving the greatest combined dietary and non-dietary exposure. Because EPA's level of concern for pendimethalin is a MOE of 30 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, pendimethalin is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no 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 intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for pendimethalin. 5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has determined that an RfD approach based on the chronic point of departure is appropriate for evaluating cancer risk. As there are not chronic aggregate risks of concern, there are no cancer aggregate risk concerns. 6. 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 pendimethalin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, gas chromatography with electron capture detection (GC/ECD), is available to enforce the tolerance expression. 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. There are currently no established Codex MRLs for the residues of pendimethalin on alfalfa hay, although Codex has established an MRL for residues of pendimethalin in alfalfa fodder (which is equivalent to the US commodity of alfalfa forage) at 4 ppm. Harmonization is not possible because use of the Codex MRL would result in residues of pendimethalin exceeding tolerances in the U.S. as a result of use in accordance with the approved label. V. Conclusion Therefore, tolerances are established for plant residues by measuring only the sum of pendimethalin, [N-(1-ethylpropyl)-3,4- dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(1- ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol calculated as the stoichiometric equivalent of pendimethalin, in or on alfalfa, forage at 80 ppm and alfalfa, hay at 150 ppm. In addition, the Agency is revising the tolerance expression for paragraph (a)(1) to clarify that the residues of the parent compound are to be summed with the residues of the metabolite in order to determine compliance with the tolerance. This revision does not substantively change the existing language; the current language already requires measurement of both residues. The insertion of the words ``the sum'' just provides a small clarification for measuring residues to determine compliance with the tolerance. 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); or 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 [[Page 6981]] 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 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 30, 2018. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. In Sec. 180.361: 0 a. Revise the introductory text of paragraph (a)(1). 0 b. Revise the entries for ``Alfalfa, forage''; and ``Alfalfa, hay'' in the table in paragraph (a)(1). The revisions read as follows: Sec. 180.361 Pendimethalin; tolerances for residues. (a)(1) General. Tolerances are established for residues of the herbicide pendimethalin, including its metabolites and degradates, in or on the commodities. Compliance with the tolerance levels specified in the following table below is to be determined by measuring only the sum of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6- dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2- methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric equivalent of pendimethalin, in or on the commodity. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Alfalfa, forage............................................ 80 Alfalfa, hay............................................... 150 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2018-03277 Filed 2-15-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Rules and Regulations 6975
rule may take effect, the agency purposes of judicial review nor does it PART 52—APPROVAL AND
promulgating the rule must submit a extend the time within which a petition PROMULGATION OF
rule report, which includes a copy of for judicial review may be filed, and IMPLEMENTATION PLANS
the rule, to each House of the Congress shall not postpone the effectiveness of
and to the Comptroller General of the such rule or action. This action may not ■ 1. The authority citation for part 52
United States. Section 804, however, be challenged later in proceedings to continues to read as follows:
exempts from section 801 the following enforce its requirements. (See section Authority: 42 U.S.C. 7401 et seq.
types of rules: Rules of particular 307(b)(2)).
applicability; rules relating to agency Subpart EE—New Hampshire
List of Subjects in 40 CFR Part 52
management or personnel; and rules of
agency organization, procedure, or Environmental protection, Air ■ 2. In § 52.1520 paragraph (c), amend
practice that do not substantially affect pollution control, Carbon monoxide, the table by:
the rights or obligations of nonagency Incorporation by reference, ■ a. Adding four entries for‘‘Env-A 100’’
parties. 5 U.S.C. 804(3). Because this is Intergovernmental relations, Lead, after the entry ‘‘Env-A 100;
a rule of particular applicability, EPA is Nitrogen dioxide, Ozone, Particulate Organizational Rules: Definitions’’;
not required to submit a rule report matter, Reporting and recordkeeping ■ b. Revising the entry ‘‘Env-A 1000’’;
regarding this action under section 801. requirements, Sulfur oxides, Volatile and
Under section 307(b)(1) of the Clean Air organic compounds. ■ c. Adding in numerical order an entry
Act, petitions for judicial review of this Dated: February 6, 2018. ‘‘Env-A 1900’’.
action must be filed in the United States Alexandra Dapolito Dunn, The revision and additions read as
Court of Appeals for the appropriate follows:
Regional Administrator, EPA New England.
circuit by November 20, 2017. Filing a
petition for reconsideration by the For the reasons set forth in the § 52.1520 Identification of plan.
Administrator of this final rule does not preamble, 40 CFR part 52 is amended as * * * * *
affect the finality of this action for the follows: (c) * * *
EPA-APPROVED NEW HAMPSHIRE REGULATIONS
State effective
State citation Title/subject EPA approval date 1 Explanations
date
* * * * * * *
Env-A 100 ........................ Definition of ‘‘Incinerator’’ 04/29/2003 02/16/2018, [Insert Fed- Remove Part Env–A 101.59, definition of
eral Register citation]. ‘‘Incinerator’’ and replace with ‘‘[re-
served].’’
Env-A 100 ........................ Definition of ‘‘Wood 04/29/2003 02/16/2018, [Insert Fed- Remove Part Env–A 101.95, definition of
Waste Burner’’. eral Register citation]. ‘‘Wood Waste Burner’’ and replace with
‘‘[reserved].’’
Env-A 100 ........................ Definition of ‘‘Incinerator’’ 04/23/2013 02/16/2018, [Insert Fed- Approve Part Env–A 101.104, definition
eral Register citation]. of ‘‘Incinerator.’’
Env-A 100 ........................ Definition of ‘‘Wood 01/14/2005 02/16/2018, [Insert Fed- Approve Part Env–A 101.219, definition
Waste Burner’’. eral Register citation]. of ‘‘Wood Waste Burner.’’
* * * * * * *
Env-A 1000 ...................... Control of Open Burning 05/01/2011 02/16/2018, [Insert Fed- Approve Part Env–A 1000 ‘‘Prevention,
eral Register citation]. Abatement and Control of Open
Source Air Pollution.’’
* * * * * * *
Env-A 1900 ...................... Emission Standards and 04/23/2013 02/16/2018, [Insert Fed- Approve Part Env–A 1900 ‘‘Incinerators
Operating Practices for eral Register citation]. and Wood Waste Burners.’’
Incinerators.
* * * * * * *
1 In
order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this col-
umn for the particular provision.
* * * * * ENVIRONMENTAL PROTECTION SUMMARY: This regulation amends the
[FR Doc. 2018–03251 Filed 2–15–18; 8:45 am] AGENCY tolerances for residues of pendimethalin
BILLING CODE 6560–50–P in or on alfalfa, forage and alfalfa, hay.
40 CFR Part 180 BASF Corporation requested these
tolerances under the Federal Food,
[EPA–HQ–OPP–2014–0247; FRL–9973–03] Drug, and Cosmetic Act (FFDCA).
daltland on DSKBBV9HB2PROD with RULES
DATES: This regulation is effective
Pendimethalin; Pesticide Tolerances February 16, 2018. Objections and
AGENCY: Environmental Protection requests for hearings must be received
Agency (EPA). on or before April 17, 2018, and must
be filed in accordance with the
ACTION: Final rule.
instructions provided in 40 CFR part
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![6976 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Rules and Regulations
178 (see also Unit I.C. of the objection to any aspect of this regulation 2-methyl-3,5-dinitrobenzyl alcohol, in
SUPPLEMENTARY INFORMATION). and may also request a hearing on those or on alfalfa, forage to 80 parts per
ADDRESSES: The docket for this action, objections. You must file your objection million (ppm) and alfalfa, hay to 150
identified by docket identification (ID) or request a hearing on this regulation ppm. That document referenced a
number EPA–HQ–OPP–2014–0247, is in accordance with the instructions summary of the petition prepared by
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure BASF Corporation, the registrant, which
or at the Office of Pesticide Programs proper receipt by EPA, you must is available in the docket EPA–HQ–
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– OPP–2014–0397 at http://
in the Environmental Protection Agency OPP–2014–0247 in the subject line on www.regulations.gov. There were no
Docket Center (EPA/DC), West William the first page of your submission. All comments received in response to the
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing notice of filing.
Constitution Ave. NW, Washington, DC must be in writing, and must be
III. Aggregate Risk Assessment and
20460–0001. The Public Reading Room received by the Hearing Clerk on or
Determination of Safety
is open from 8:30 a.m. to 4:30 p.m., before April 17, 2018. Addresses for
Monday through Friday, excluding legal mail and hand delivery of objections Section 408(b)(2)(A)(i) of FFDCA
holidays. The telephone number for the and hearing requests are provided in 40 allows EPA to establish a tolerance (the
CFR 178.25(b). legal limit for a pesticide chemical
Public Reading Room is (202) 566–1744,
In addition to filing an objection or residue in or on a food) only if EPA
and the telephone number for the OPP
hearing request with the Hearing Clerk determines that the tolerance is ‘‘safe.’’
Docket is (703) 305–5805. Please review
as described in 40 CFR part 178, please Section 408(b)(2)(A)(ii) of FFDCA
the visitor instructions and additional
submit a copy of the filing (excluding defines ‘‘safe’’ to mean that ‘‘there is a
information about the docket available
any Confidential Business Information reasonable certainty that no harm will
at http://www.epa.gov/dockets.
(CBI)) for inclusion in the public docket. result from aggregate exposure to the
FOR FURTHER INFORMATION CONTACT: pesticide chemical residue, including
Information not marked confidential
Michael L. Goodis, Director, all anticipated dietary exposures and all
pursuant to 40 CFR part 2 may be
Registration Division (7505P), Office of other exposures for which there is
disclosed publicly by EPA without prior
Pesticide Programs, Environmental reliable information.’’ This includes
notice. Submit the non-CBI copy of your
Protection Agency, 1200 Pennsylvania exposure through drinking water and in
objection or hearing request, identified
Ave. NW, Washington, DC 20460–0001; residential settings, but does not include
by docket ID number EPA–HQ–OPP–
main telephone number: (703) 305– occupational exposure. Section
2014–0247, by one of the following
7090; email address: RDFRNotices@ 408(b)(2)(C) of FFDCA requires EPA to
methods:
epa.gov. • Federal eRulemaking Portal: http:// give special consideration to exposure
SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online of infants and children to the pesticide
instructions for submitting comments. chemical residue in establishing a
I. General Information
Do not submit electronically any tolerance and to ‘‘ensure that there is a
A. Does this action apply to me? information you consider to be CBI or reasonable certainty that no harm will
You may be potentially affected by other information whose disclosure is result to infants and children from
this action if you are an agricultural restricted by statute. aggregate exposure to the pesticide
producer, food manufacturer, or • Mail: OPP Docket, Environmental chemical residue. . . .’’
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ Consistent with FFDCA section
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. 408(b)(2)(D), and the factors specified in
Classification System (NAICS) codes is NW, Washington, DC 20460–0001. FFDCA section 408(b)(2)(D), EPA has
not intended to be exhaustive, but rather • Hand Delivery: To make special reviewed the available scientific data
provides a guide to help readers arrangements for hand delivery or and other relevant information in
determine whether this document delivery of boxed information, please support of this action. EPA has
applies to them. Potentially affected follow the instructions at http:// sufficient data to assess the hazards of
entities may include: www.epa.gov/dockets/contacts.html. and to make a determination on
• Crop production (NAICS code 111). Additional instructions on aggregate exposure for pendimethalin
• Animal production (NAICS code commenting or visiting the docket, including exposure resulting from the
112). along with more information about tolerances established by this action.
• Food manufacturing (NAICS code dockets generally, is available at http:// EPA’s assessment of exposures and risks
311). www.epa.gov/dockets. associated with pendimethalin follows.
• Pesticide manufacturing (NAICS II. Summary of Petitioned-For A. Toxicological Profile
code 32532). Tolerance EPA has evaluated the available
B. How can I get electronic access to In the Federal Register of August 1, toxicity data and considered its validity,
other related information? 2014 (79 FR 44729) (FRL–9911–67), completeness, and reliability as well as
You may access a frequently updated EPA issued a document pursuant to the relationship of the results of the
electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C. studies to human risk. EPA has also
regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a considered available information
the Government Printing Office’s e-CFR pesticide petition (PP 4F8245) by BASF concerning the variability of the
site at http://www.ecfr.gov/cgi-bin/text- Corporation, 26 Davis Drive, Research sensitivities of major identifiable
Triangle Park, NC 27709. The petition
daltland on DSKBBV9HB2PROD with RULES
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ subgroups of consumers, including
40tab_02.tpl. requested that 40 CFR 180.361 be infants and children.
amended by increasing the tolerances The target organ for pendimethalin is
C. How can I file an objection or hearing for residues of the herbicide the thyroid. Thyroid toxicity in chronic
request? pendimethalin, [N-(1-ethylpropyl)-3,4- and subchronic rat and mouse studies
Under FFDCA section 408(g), 21 dimethyl-2,6-dinitrobenzenamine], and was manifested as alterations in thyroid
U.S.C. 346a, any person may file an its metabolite, 4-[(1-ethylpropyl)amino]- hormones (decreased total T4 and T3,
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![6980 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Rules and Regulations
safe by comparing aggregate exposure risk is assessed based on intermediate- There are currently no established
estimates to the acute PAD (aPAD) and term residential exposure plus chronic Codex MRLs for the residues of
chronic PAD (cPAD). For linear cancer dietary exposure. Because there is no pendimethalin on alfalfa hay, although
risks, EPA calculates the lifetime intermediate-term residential exposure Codex has established an MRL for
probability of acquiring cancer given the and chronic dietary exposure has residues of pendimethalin in alfalfa
estimated aggregate exposure. Short-, already been assessed under the fodder (which is equivalent to the US
intermediate-, and chronic-term risks appropriately protective cPAD (which is commodity of alfalfa forage) at 4 ppm.
are evaluated by comparing the at least as protective as the POD used to Harmonization is not possible because
estimated aggregate food, water, and assess intermediate-term risk), no use of the Codex MRL would result in
residential exposure to the appropriate further assessment of intermediate-term residues of pendimethalin exceeding
PODs to ensure that an adequate MOE risk is necessary, and EPA relies on the tolerances in the U.S. as a result of use
exists. chronic dietary risk assessment for in accordance with the approved label.
1. Acute risk. Using the exposure evaluating intermediate-term risk for
assumptions discussed in this unit for V. Conclusion
pendimethalin.
acute exposure, the acute dietary 5. Aggregate cancer risk for U.S. Therefore, tolerances are established
exposure from food and water to population. As discussed in Unit III.A., for plant residues by measuring only the
pendimethalin will occupy 2% of the EPA has determined that an RfD sum of pendimethalin, [N-(1-
aPAD for all infants less than 1 year old, approach based on the chronic point of ethylpropyl)-3,4-dimethyl-2,6-
the population group receiving the departure is appropriate for evaluating dinitrobenzenamine], and its metabolite,
greatest exposure. cancer risk. As there are not chronic 4-[(1-ethylpropyl)amino]-2-methyl-3,5-
2. Chronic risk. Using the exposure aggregate risks of concern, there are no dinitrobenzyl alcohol calculated as the
assumptions described in this unit for cancer aggregate risk concerns. stoichiometric equivalent of
chronic exposure, EPA has concluded 6. Determination of safety. Based on pendimethalin, in or on alfalfa, forage at
that chronic exposure to pendimethalin these risk assessments, EPA concludes 80 ppm and alfalfa, hay at 150 ppm. In
from food and water will utilize 2.4% of that there is a reasonable certainty that addition, the Agency is revising the
the cPAD for children one to two years no harm will result to the general tolerance expression for paragraph (a)(1)
old the population group receiving the population, or to infants and children to clarify that the residues of the parent
greatest exposure. Based on the from aggregate exposure to compound are to be summed with the
explanation in Unit III.C.3., regarding pendimethalin residues. residues of the metabolite in order to
residential use patterns, chronic determine compliance with the
residential exposure to residues of IV. Other Considerations tolerance. This revision does not
pendimethalin is not expected. A. Analytical Enforcement Methodology substantively change the existing
3. Short-term risk. Short-term language; the current language already
aggregate exposure takes into account Adequate enforcement methodology, requires measurement of both residues.
short-term residential exposure plus gas chromatography with electron The insertion of the words ‘‘the sum’’
chronic exposure to food and water capture detection (GC/ECD), is available just provides a small clarification for
(considered to be a background to enforce the tolerance expression. measuring residues to determine
exposure level). The method may be requested from: compliance with the tolerance.
Pendimethalin is currently registered Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 VI. Statutory and Executive Order
for uses that could result in short-term
Mapes Rd., Ft. Meade, MD 20755–5350; Reviews
residential exposure, and the Agency
has determined that it is appropriate to telephone number: (410) 305–2905; This action establishes tolerances
aggregate chronic exposure through food email address: residuemethods@ under FFDCA section 408(d) in
and water with short-term residential epa.gov. response to a petition submitted to the
exposures to pendimethalin. Agency. The Office of Management and
B. International Residue Limits Budget (OMB) has exempted these types
Using the exposure assumptions
described in this unit for short-term In making its tolerance decisions, EPA of actions from review under Executive
exposures, EPA has concluded the seeks to harmonize U.S. tolerances with Order 12866, entitled ‘‘Regulatory
combined short-term food, water, and international standards whenever Planning and Review’’ (58 FR 51735,
residential exposures result in aggregate possible, consistent with U.S. food October 4, 1993). Because this action
MOEs of 130 for adults and 92 for safety standards and agricultural has been exempted from review under
children 1–2 years old, the two practices. EPA considers the Executive Order 12866, this action is
population subgroups receiving the international maximum residue limits not subject to Executive Order 13211,
greatest combined dietary and non- (MRLs) established by the Codex entitled ‘‘Actions Concerning
dietary exposure. Because EPA’s level of Alimentarius Commission (Codex), as Regulations That Significantly Affect
concern for pendimethalin is a MOE of required by FFDCA section 408(b)(4). Energy Supply, Distribution, or Use’’ (66
30 or below, these MOEs are not of The Codex Alimentarius is a joint FR 28355, May 22, 2001); Executive
concern. United Nations Food and Agriculture Order 13045, entitled ‘‘Protection of
4. Intermediate-term risk. Organization/World Health Children from Environmental Health
Intermediate-term aggregate exposure Organization food standards program, Risks and Safety Risks’’ (62 FR 19885,
takes into account intermediate-term and it is recognized as an international April 23, 1997); or Executive Order
residential exposure plus chronic food safety standards-setting 13771, entitled ‘‘Reducing Regulations
organization in trade agreements to and Controlling Regulatory Costs’’ (82
daltland on DSKBBV9HB2PROD with RULES
exposure to food and water (considered
to be a background exposure level). which the United States is a party. EPA FR 9339, February 3, 2017). This action
An intermediate-term adverse effect may establish a tolerance that is does not contain any information
was identified; however, pendimethalin different from a Codex MRL; however, collections subject to OMB approval
is not registered for any use patterns FFDCA section 408(b)(4) requires that under the Paperwork Reduction Act
that would result in intermediate-term EPA explain the reasons for departing (PRA) (44 U.S.C. 3501 et seq.), nor does
residential exposure. Intermediate-term from the Codex level. it require any special considerations
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![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Rules and Regulations 6981
under Executive Order 12898, entitled and pests, Reporting and recordkeeping ACTION: Final rule.
‘‘Federal Actions to Address requirements.
Environmental Justice in Minority SUMMARY: The Environmental Protection
Dated: January 30, 2018. Agency (EPA) Region 1 announces the
Populations and Low-Income Daniel J. Rosenblatt,
Populations’’ (59 FR 7629, February 16, deletion of the Hatheway & Patterson
Acting Director, Registration Division, Office Superfund Site (Site) located in
1994). of Pesticide Programs.
Since tolerances and exemptions that Mansfield and Foxborough,
are established on the basis of a petition Therefore, 40 CFR chapter I is Massachusetts, from the National
under FFDCA section 408(d), such as amended as follows: Priorities List (NPL). The NPL,
the tolerances in this final rule, do not promulgated pursuant to section 105 of
PART 180—[AMENDED] the Comprehensive Environmental
require the issuance of a proposed rule,
the requirements of the Regulatory Response, Compensation, and Liability
■ 1. The authority citation for part 180 Act (CERCLA) of 1980, as amended, is
Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
seq.), do not apply. an appendix of the National Oil and
Authority: 21 U.S.C. 321(q), 346a and 371. Hazardous Substances Pollution
This action directly regulates growers,
■ 2. In § 180.361:
Contingency Plan (NCP). The EPA and
food processors, food handlers, and food
■ a. Revise the introductory text of
the Commonwealth of Massachusetts,
retailers, not States or tribes, nor does
paragraph (a)(1). through the Massachusetts Department
this action alter the relationships or
■ b. Revise the entries for ‘‘Alfalfa,
of Environmental Protection (MassDEP),
distribution of power and
forage’’; and ‘‘Alfalfa, hay’’ in the table have determined that all appropriate
responsibilities established by Congress
in paragraph (a)(1). response actions under CERCLA, other
in the preemption provisions of FFDCA
The revisions read as follows: than operation and maintenance,
section 408(n)(4). As such, the Agency
monitoring, and five-year reviews, have
has determined that this action will not
§ 180.361 Pendimethalin; tolerances for been completed. However, this deletion
have a substantial direct effect on States residues. does not preclude future actions under
or tribal governments, on the
(a)(1) General. Tolerances are Superfund.
relationship between the national
government and the States or tribal established for residues of the herbicide DATES: This action is effective February
governments, or on the distribution of pendimethalin, including its 16, 2018.
power and responsibilities among the metabolites and degradates, in or on the ADDRESSES: Docket: EPA has established
various levels of government or between commodities. Compliance with the a docket for this action under Docket
the Federal Government and Indian tolerance levels specified in the Identification No. EPA–HQ–SFUND–
tribes. Thus, the Agency has determined following table below is to be 2002–0001. All documents in the docket
that Executive Order 13132, entitled determined by measuring only the sum are listed on the http://
‘‘Federalism’’ (64 FR 43255, August 10, of pendimethalin, [N-(1-ethylpropyl)- www.regulations.gov website. Although
1999) and Executive Order 13175, 3,4-dimethyl-2,6-dinitrobenzenamine] listed in the index, some information is
entitled ‘‘Consultation and Coordination and its metabolite, 4-[(1- not publicly available, i.e., Confidential
with Indian Tribal Governments’’ (65 FR ethylpropyl)amino]-2-methyl-3,5- Business Information or other
67249, November 9, 2000) do not apply dinitrobenzyl alcohol, calculated as the information whose disclosure is
to this action. In addition, this action stoichiometric equivalent of restricted by statute. Certain other
does not impose any enforceable duty or pendimethalin, in or on the commodity. material, such as copyrighted material,
contain any unfunded mandate as is not placed on the internet and will be
Parts publicly available only in hard copy
described under Title II of the Unfunded Commodity per
Mandates Reform Act (UMRA) (2 U.S.C. million form. Publicly available docket
1501 et seq.). materials are available either
This action does not involve any Alfalfa, forage ........................... 80 electronically through http://
technical standards that would require Alfalfa, hay ................................ 150 www.regulations.gov or in hard copy at
Agency consideration of voluntary the site information repositories.
* * * * * Locations, contacts, phone numbers and
consensus standards pursuant to section
12(d) of the National Technology viewing hours are:
* * * * * U.S. EPA Region 1, Superfund
Transfer and Advancement Act [FR Doc. 2018–03277 Filed 2–15–18; 8:45 am]
(NTTAA) (15 U.S.C. 272 note). Records Center, 5 Post Office Square,
BILLING CODE 6560–50–P Suite 100, Boston, MA 02109, Phone:
VII. Congressional Review Act 617–918–1440, Monday–Friday: 9:00
Pursuant to the Congressional Review a.m.–5:00 p.m., Saturday and Sunday—
ENVIRONMENTAL PROTECTION Closed.
Act (5 U.S.C. 801 et seq.), EPA will AGENCY
submit a report containing this rule and FOR FURTHER INFORMATION CONTACT:
other required information to the U.S. 40 CFR Part 300 Kimberly White, Remedial Project
Senate, the U.S. House of Manager, U.S. Environmental Protection
Representatives, and the Comptroller [EPA–HQ–SFUND–2002–0001; FRL–9974– Agency, Region 1, OSRR07–1, Boston,
43—Region 1] MA 02109–3912, (617) 918–1752, email:
General of the United States prior to
publication of the rule in the Federal white.kimberly@epa.gov.
National Oil and Hazardous
Register. This action is not a ‘‘major INFORMATION: The site to
daltland on DSKBBV9HB2PROD with RULES
Substances Pollution Contingency SUPPLEMENTARY
rule’’ as defined by 5 U.S.C. 804(2). Plan; National Priorities List: Deletion be deleted from the NPL is: Hatheway
of the Hatheway & Patterson & Patterson Superfund Site, Mansfield
List of Subjects in 40 CFR Part 180
Superfund Site and Foxborough, Massachusetts. A
Environmental protection, notification of deletion for this Site was
Administrative practice and procedure, AGENCY: Environmental Protection published in the Federal Register (82
Agricultural commodities, Pesticides Agency. FR 56939) on December 1, 2017.
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Document Created: 2018-02-16 00:55:25
Document Modified: 2018-02-16 00:55:25
| 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 16, 2018. Objections and requests for hearings must be received on or before April 17, 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 L. Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, | |
| FR Citation | 83 FR 6975 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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