81 FR 78913 - Clomazone; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 218 (November 10, 2016)
Federal Register Volume 81, Issue 218 (November 10, 2016)
| Page Range | 78913-78917 | |
| FR Document | 2016-27201 |
[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)] [Rules and Regulations] [Pages 78913-78917] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27201] [[Page 78913]] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0712; FRL-9953-88] Clomazone; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of clomazone in or on asparagus and soybean, vegetable, succulent. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 10, 2016. Objections and requests for hearings must be received on or before January 9, 2017, 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-2015-0712, 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-2015-0712 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 January 9, 2017. 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-2015-0712, 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 November 25, 2015 (80 FR 73695) (FRL- 9937-14), 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# 5E8402) by Interregional Research No. 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201-W, Princeton, NJ 08540. The petition requested that 40 CFR 180.425 be amended by establishing tolerances for residues of the herbicide clomazone, 2-[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, in or on asparagus at 0.05 parts per million (ppm) and vegetable soybean (edamame) at 0.05 ppm. That document referenced a summary of the petition prepared by FMC Corporation, the registrant, which is available in the docket EPA-HQ-OPP-2015-0712 at http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has revised the terminology to correct the commodity definition from vegetable soybean (edamame) to soybean, vegetable, succulent. 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. . . .'' [[Page 78914]] 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 clomazone including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with clomazone 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 of clomazone is the liver, with hepatocellular cytomegaly and increased liver weight noted in the subchronic rat study. No neurotoxicity studies with clomazone are available; however, based on a weight of the evidence approach, EPA has concluded that a neurotoxicity battery is not required for clomazone. This approach considered all of the available hazard and exposure information including: (1) There is no evidence of clinical signs of neurotoxicity or neuropathology in adult animals in subchronic and chronic studies; (2) the liver is the target organ for clomazone, not the neurological system; (3) clomazone is absorbed and rapidly excreted in rats with 97% of the radioactivity excreted within 168 hours; and (4) the point of departure (POD) and endpoint for chronic dietary risk assessment is based on liver effects in rats which appear to be the most sensitive endpoint. There is no quantitative or qualitative evidence of susceptibility in the developmental toxicity study in rabbits or in the 2-generation reproduction toxicity study in rats. In the developmental toxicity study in rats, delayed ossification occurred at doses that produced maternal effects (chromorhinorrhea and abdominogenital staining). Although qualitative susceptibility was observed in the developmental toxicity study in rats, the concern is low since there are clear no-observed-adverse-effect-levels (NOAELs) and lowest- observed-adverse-effect-levels (LOAELs) in the study and this study was used for risk assessment, and therefore, is protective of the developmental effects. In the rat and mouse carcinogenicity studies, there was no evidence of carcinogenicity. Although the mouse carcinogenicity study was classified as unacceptable/guideline since no systemic toxicity was observed at the highest dose tested, the study was considered adequate to assess the carcinogenicity in mice. EPA has determined that an additional mouse carcinogenicity study is not needed. This finding is based upon the following conclusions: (1) The rat is more sensitive than the mouse for the chronic assessment; (2) the consistent effect in rats (decreased body weight and increased liver weight) has been used as the point of departure for the chronic assessment; (3) a new mouse study would only use doses well above the current POD for the chronic assessment; and (4) even if a new mouse study identified positive carcinogenicity effects, that finding would not result in the adoption of a quantitative linear assessment of cancer risk due to the negative carcinogenicity finding in the rat study and the lack of a positive finding for genotoxicity. Clomazone is classified as ``Not Likely to be Carcinogenic to Humans.'' Quantification of cancer risk is not required. Specific information on the studies received and the nature of the adverse effects caused by clomazone as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document ``Clomazone: Human Health Risk Assessment for the Use of Clomazone on Asparagus and Edamame (Vegetable Soybean)'' on pages 11-15 in docket ID number EPA-HQ-OPP-2015-0712. 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://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for clomazone used for human risk assessment used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Clomazone 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 An endpoint was not selected for the general population because no adverse including infants and children). effect in adult animals was identified that resulted from a single exposure. A risk assessment is not required for this population subgroup. ------------------------------------------------------------------------------ Acute dietary (Females 13 to 49 NOAEL = 100 mg/kg/ Acute RfD = 1.0 mg/ Developmental Toxicity Study--Rats years of age). day. kg/day. (MRID 00150291). UFA = 10x........... aPAD = 1.0 mg/kg/ LOAEL = 300 mg/kg/day based on UFH = 10x........... day. indications of delayed FQPA SF = 1x........ ossification in the form of either partial ossification or the absence of the manubrium, sternebrae 3-4, xiphoid, caudal vertebrae, and meta-carpals. [[Page 78915]] Chronic dietary (All populations) NOAEL= 84.4 mg/kg/ Chronic RfD = 0.84 Two Year Chronic Toxicity Study-- day. mg/kg/day. Rats (MRID 00132586). UFA = 10x........... cPAD = 0.84 mg/kg/ NOAEL = 84.4/112.9 mg/kg/day, UFH = 10x........... day. males/females (highest dose FQPA SF = 1x........ tested). LOAEL was not attained Co-critical 90-day Oral Rat Study (MRID 00132586). NOAEL = 135.2/160.9 mg/kg/day, males/females. LOAEL = 273/319.3 mg/kg/day, males/ females, based on decreased body weight, body weight gains, food consumption and increased absolute and relative liver weights in females and increased absolute liver weights in males. Co-critical 2-Generation Reproduction Toxicity Study (MRID 00151108). Parental LOAEL = 100 mg/kg/day based on statistically significantly decreased body weight & body weight gain during pre-mating, and decreased body weight during gestation & lactation M & F. In addition, decreased food consumption in females and hydronephritic kidneys in males. ------------------------------------------------------------------------------ Cancer (Oral, dermal, inhalation) ``Not Likely to be Carcinogenic to Humans.'' Quantitative assessment of cancer risk is not required. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. 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 clomazone, EPA considered exposure under the petitioned-for tolerances as well as all existing clomazone tolerances in 40 CFR 180.425. EPA assessed dietary exposures from clomazone 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 clomazone. In estimating acute dietary exposure, EPA used the 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 incorporated tolerance-level residues, 100 percent crop treated (PCT) for all commodities, and DEEM 7.81 default processing factors as appropriate. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used DEEM-FCID Version 3.16. This software uses 2003- 2008 food consumption data from USDA's NHANES/WWEIA. As to residue levels in food, EPA incorporated tolerance-level residues, 100 PCT for all commodities, and DEEM 7.81 default processing factors as appropriate. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that clomazone 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 clomazone. Tolerance level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. In drinking water, the residues of concern include clomazone parent and its degradate FMC65317 (N-[(2-chlorophenyl)methyl]-3-hydroxy-2,2-dimenthylpropanamide). The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for clomazone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of clomazone. 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 Tier 1 Rice Model and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of clomazone for acute exposures are estimated to be 550 parts per billion (ppb) for surface water and 85.7 ppb for ground water. The EDWCs of clomazone for chronic exposures for non-cancer assessments are estimated to be 550 ppb for surface water and 77.4 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both acute and chronic dietary risk assessment, the water concentration value of 550 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). Clomazone 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 78916]] substances that have a common mechanism of toxicity.'' EPA has not found clomazone to share a common mechanism of toxicity with any other substances, and clomazone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that clomazone 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 Web site 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 evidence of increased quantitative or qualitative susceptibility in the prenatal developmental toxicity study in rabbits or in the reproductive toxicity study in rats with clomazone. In the developmental toxicity study in rats, effects in the fetuses (delayed ossification) occurred at doses that produced maternal effects (chromorhinorrhea and abdominogenital staining) but were qualitatively more severe. Although qualitative susceptibility was observed in the developmental toxicity study in rats, the concern is low since there are clear NOAELs and LOAELs in this study and the NOAEL in the study was used as the POD for assessment of acute risk. EPA's assessment of acute risk is therefore protective of any developmental effects. 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 clomazone is complete. ii. There is no indication that clomazone is a neurotoxic chemical and there is no need for additional UFs to account for neurotoxicity. iii. For the reasons described above in Unit III.D.2., there is low concern regarding increased susceptibility in the young from exposure to clomazone. 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 clomazone in drinking water. There are no existing or pending residential uses. Therefore, these assessments will not underestimate the exposure and risks posed by clomazone. 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). 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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected for the general population including infants and children. Therefore, clomazone is not expected to pose an acute risk to these groups. However, an acute endpoint was identified for females 13 to 49 years old due to effects observed in fetuses. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to clomazone will occupy 3.0% of the aPAD for females 13 to 49 years old. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to clomazone from food and water will utilize 3.6% of the cPAD for all infants <1 year old, the population group receiving the greatest exposure. There are no residential uses for clomazone. 3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposures take into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Clomazone is not registered for any use patterns that would result in short- or intermediate-term residential exposure. Because there are no short- or intermediate-term residential exposures and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- and intermediate-term risks), no further assessment of short- and intermediate-term risks are necessary. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in rodent carcinogenicity studies, along with the data summarized in Unit III.A., clomazone 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 clomazone residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography (GC) using a nitrogen phosphorus detector (NPD) or mass spectrometer (MS)) 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 [[Page 78917]] EPA explain the reasons for departing from the Codex level. The Codex has not established any MRLs for clomazone. V. Conclusion Therefore, tolerances are established for residues of clomazone, 2- [(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, in or on asparagus 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) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). 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: October 21, 2016. Michael Goodis, 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. 180.425, add alphabetically the commodities ``Asparagus'' and ``Soybean, vegetable, succulent'' to the table in paragraph (a) to read as follows: Sec. 180.425 Clomazone; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Asparagus................................................... 0.05 * * * * * Soybean, vegetable, succulent............................... 0.05 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2016-27201 Filed 11-9-16; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations 78913
ENVIRONMENTAL PROTECTION applies to them. Potentially affected follow the instructions at http://
AGENCY entities may include: www.epa.gov/dockets/contacts.html.
• Crop production (NAICS code 111). Additional instructions on
40 CFR Part 180 • Animal production (NAICS code commenting or visiting the docket,
112). along with more information about
[EPA–HQ–OPP–2015–0712; FRL–9953–88]
• Food manufacturing (NAICS code dockets generally, is available at http://
Clomazone; Pesticide Tolerances 311). www.epa.gov/dockets.
• Pesticide manufacturing (NAICS
AGENCY: Environmental Protection code 32532). II. Summary of Petitioned-For
Agency (EPA). Tolerance
B. How can I get electronic access to In the Federal Register of November
ACTION: Final rule.
other related information? 25, 2015 (80 FR 73695) (FRL–9937–14),
SUMMARY: This regulation establishes You may access a frequently updated EPA issued a document pursuant to
tolerances for residues of clomazone in electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
or on asparagus and soybean, vegetable, regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
succulent. The Interregional Research the Government Printing Office’s e-CFR pesticide petition (PP# 5E8402) by
Project Number 4 (IR–4) requested these site at http://www.ecfr.gov/cgi-bin/text- Interregional Research No. 4 (IR–4),
tolerances under the Federal Food, idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Rutgers, The State University of New
Drug, and Cosmetic Act (FFDCA). 40tab_02.tpl. Jersey, 500 College Road East, Suite
DATES: This regulation is effective 201–W, Princeton, NJ 08540. The
November 10, 2016. Objections and C. How can I file an objection or hearing
petition requested that 40 CFR 180.425
requests for hearings must be received request? be amended by establishing tolerances
on or before January 9, 2017, and must Under FFDCA section 408(g), 21 for residues of the herbicide clomazone,
be filed in accordance with the U.S.C. 346a, any person may file an 2-[(2-chlorophenyl)methyl]-4,4-
instructions provided in 40 CFR part objection to any aspect of this regulation dimethyl-3-isoxazolidinone, in or on
178 (see also Unit I.C. of the and may also request a hearing on those asparagus at 0.05 parts per million
SUPPLEMENTARY INFORMATION). objections. You must file your objection (ppm) and vegetable soybean (edamame)
ADDRESSES: The docket for this action, or request a hearing on this regulation at 0.05 ppm. That document referenced
identified by docket identification (ID) in accordance with the instructions a summary of the petition prepared by
number EPA–HQ–OPP–2015–0712, is provided in 40 CFR part 178. To ensure FMC Corporation, the registrant, which
available at http://www.regulations.gov proper receipt by EPA, you must is available in the docket EPA–HQ–
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– OPP–2015–0712 at http://
Regulatory Public Docket (OPP Docket) OPP–2015–0712 in the subject line on www.regulations.gov. There were no
in the Environmental Protection Agency the first page of your submission. All comments received in response to the
Docket Center (EPA/DC), West William objections and requests for a hearing notice of filing.
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be Based upon review of the data
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or supporting the petition, EPA has revised
20460–0001. The Public Reading Room before January 9, 2017. Addresses for the terminology to correct the
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections commodity definition from vegetable
Monday through Friday, excluding legal and hearing requests are provided in 40 soybean (edamame) to soybean,
holidays. The telephone number for the CFR 178.25(b). vegetable, succulent.
Public Reading Room is (202) 566–1744, In addition to filing an objection or
III. Aggregate Risk Assessment and
and the telephone number for the OPP hearing request with the Hearing Clerk
Determination of Safety
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
the visitor instructions and additional submit a copy of the filing (excluding Section 408(b)(2)(A)(i) of FFDCA
information about the docket available any Confidential Business Information allows EPA to establish a tolerance (the
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. legal limit for a pesticide chemical
Information not marked confidential residue in or on a food) only if EPA
FOR FURTHER INFORMATION CONTACT:
pursuant to 40 CFR part 2 may be determines that the tolerance is ‘‘safe.’’
Michael Goodis, Registration Division Section 408(b)(2)(A)(ii) of FFDCA
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your defines ‘‘safe’’ to mean that ‘‘there is a
Environmental Protection Agency, 1200 reasonable certainty that no harm will
Pennsylvania Ave. NW., Washington, objection or hearing request, identified
by docket ID number EPA–HQ–OPP– result from aggregate exposure to the
DC 20460–0001; main telephone pesticide chemical residue, including
number: (703) 305–7090; email address: 2015–0712, by one of the following
methods: all anticipated dietary exposures and all
RDFRNotices@epa.gov.
• Federal eRulemaking Portal: http:// other exposures for which there is
SUPPLEMENTARY INFORMATION: reliable information.’’ This includes
www.regulations.gov. Follow the online
I. General Information instructions for submitting comments. exposure through drinking water and in
Do not submit electronically any residential settings, but does not include
A. Does this action apply to me? information you consider to be CBI or occupational exposure. Section
You may be potentially affected by other information whose disclosure is 408(b)(2)(C) of FFDCA requires EPA to
asabaliauskas on DSK3SPTVN1PROD with RULES
this action if you are an agricultural restricted by statute. give special consideration to exposure
producer, food manufacturer, or • Mail: OPP Docket, Environmental of infants and children to the pesticide
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ chemical residue in establishing a
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. tolerance and to ‘‘ensure that there is a
Classification System (NAICS) codes is NW., Washington, DC 20460–0001. reasonable certainty that no harm will
not intended to be exhaustive, but rather • Hand Delivery: To make special result to infants and children from
provides a guide to help readers arrangements for hand delivery or aggregate exposure to the pesticide
determine whether this document delivery of boxed information, please chemical residue. . . .’’
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![Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations 78915
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CLOMAZONE FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Point of departure RfD, PAD, LOC for
Exposure/scenario and uncertainty/ Study and toxicological effects
risk assessment
safety factors
Chronic dietary (All populations) NOAEL= 84.4 mg/ Chronic RfD = 0.84 Two Year Chronic Toxicity Study—Rats (MRID 00132586).
kg/day. mg/kg/day. NOAEL = 84.4/112.9 mg/kg/day, males/females (highest dose
UFA = 10x ................ cPAD = 0.84 mg/kg/ tested).
UFH = 10x ................ day. LOAEL was not attained Co-critical 90-day Oral Rat Study
FQPA SF = 1x ......... (MRID 00132586).
NOAEL = 135.2/160.9 mg/kg/day, males/females.
LOAEL = 273/319.3 mg/kg/day, males/females, based on de-
creased body weight, body weight gains, food consumption
and increased absolute and relative liver weights in females
and increased absolute liver weights in males.
Co-critical 2-Generation Reproduction Toxicity Study (MRID
00151108).
Parental LOAEL = 100 mg/kg/day based on statistically signifi-
cantly decreased body weight & body weight gain during pre-
mating, and decreased body weight during gestation & lacta-
tion M & F. In addition, decreased food consumption in fe-
males and hydronephritic kidneys in males.
Cancer (Oral, dermal, inhala- ‘‘Not Likely to be Carcinogenic to Humans.’’ Quantitative assessment of cancer risk is not required.
tion).
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. 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 NHANES/WWEIA. As to residue levels Based on the Tier 1 Rice Model and
1. Dietary exposure from food and in food, EPA incorporated tolerance- Pesticide Root Zone Model Ground
feed uses. In evaluating dietary level residues, 100 PCT for all Water (PRZM GW), the estimated
exposure to clomazone, EPA considered commodities, and DEEM 7.81 default drinking water concentrations (EDWCs)
exposure under the petitioned-for processing factors as appropriate. of clomazone for acute exposures are
tolerances as well as all existing iii. Cancer. Based on the data estimated to be 550 parts per billion
clomazone tolerances in 40 CFR summarized in Unit III.A., EPA has (ppb) for surface water and 85.7 ppb for
180.425. EPA assessed dietary concluded that clomazone does not pose ground water. The EDWCs of clomazone
exposures from clomazone in food as a cancer risk to humans. Therefore, a for chronic exposures for non-cancer
follows: dietary exposure assessment for the assessments are estimated to be 550 ppb
i. Acute exposure. Quantitative acute purpose of assessing cancer risk is for surface water and 77.4 ppb for
dietary exposure and risk assessments unnecessary. ground water.
are performed for a food-use pesticide, Modeled estimates of drinking water
iv. Anticipated residue and PCT concentrations were directly entered
if a toxicological study has indicated the
information. EPA did not use into the dietary exposure model. For
possibility of an effect of concern
occurring as a result of a 1-day or single anticipated residue or PCT information both acute and chronic dietary risk
exposure. Such effects were identified in the dietary assessment for clomazone. assessment, the water concentration
for clomazone. In estimating acute Tolerance level residues and 100 PCT value of 550 ppb was used to assess the
dietary exposure, EPA used the Dietary were assumed for all food commodities. contribution to drinking water.
Exposure Evaluation Model software 2. Dietary exposure from drinking 3. From non-dietary exposure. The
with the Food Commodity Intake water. In drinking water, the residues of term ‘‘residential exposure’’ is used in
Database (DEEM–FCID) Version 3.16. concern include clomazone parent and this document to refer to non-
This software uses 2003–2008 food its degradate FMC65317 (N-[(2- occupational, non-dietary exposure
consumption data from the U.S. chlorophenyl)methyl]-3-hydroxy-2,2- (e.g., for lawn and garden pest control,
Department of Agriculture’s (USDA’s) dimenthylpropanamide). The Agency indoor pest control, termiticides, and
National Health and Nutrition used screening level water exposure flea and tick control on pets).
Examination Survey, What We Eat in models in the dietary exposure analysis Clomazone is not registered for any
America, (NHANES/WWEIA). As to and risk assessment for clomazone in specific use patterns that would result
residue levels in food, EPA incorporated drinking water. These simulation in residential exposure.
tolerance-level residues, 100 percent models take into account data on the 4. Cumulative effects from substances
asabaliauskas on DSK3SPTVN1PROD with RULES
crop treated (PCT) for all commodities, physical, chemical, and fate/transport with a common mechanism of toxicity.
and DEEM 7.81 default processing characteristics of clomazone. Further Section 408(b)(2)(D)(v) of FFDCA
factors as appropriate. information regarding EPA drinking requires that, when considering whether
ii. Chronic exposure. In conducting water models used in pesticide to establish, modify, or revoke a
the chronic dietary exposure assessment exposure assessment can be found at tolerance, the Agency consider
EPA used DEEM–FCID Version 3.16. http://www2.epa.gov/pesticide-science- ‘‘available information’’ concerning the
This software uses 2003–2008 food and-assessing-pesticide-risks/about- cumulative effects of a particular
consumption data from USDA’s water-exposure-models-used-pesticide. pesticide’s residues and ‘‘other
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![Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations 78917
EPA explain the reasons for departing various levels of government or between Parts per
Commodity
from the Codex level. the Federal Government and Indian million
The Codex has not established any tribes. Thus, the Agency has determined
MRLs for clomazone. that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10, * * * * *
V. Conclusion
1999) and Executive Order 13175,
Therefore, tolerances are established entitled ‘‘Consultation and Coordination * * * * *
for residues of clomazone, 2-[(2- [FR Doc. 2016–27201 Filed 11–9–16; 8:45 am]
with Indian Tribal Governments’’ (65 FR
chlorophenyl)methyl]-4,4-dimethyl-3- 67249, November 9, 2000) do not apply BILLING CODE 6560–50–P
isoxazolidinone, in or on asparagus at to this action. In addition, this action
0.05 ppm and soybean, vegetable, does not impose any enforceable duty or
succulent at 0.05 ppm. ENVIRONMENTAL PROTECTION
contain any unfunded mandate as
AGENCY
VI. Statutory and Executive Order described under Title II of the Unfunded
Reviews Mandates Reform Act (UMRA) (2 U.S.C. 40 CFR Part 180
1501 et seq.).
This action establishes tolerances This action does not involve any
under FFDCA section 408(d) in technical standards that would require [EPA–HQ–OPP–2015–0722; FRL–9953–71]
response to a petition submitted to the
Agency consideration of voluntary Prothioconazole; Pesticide Tolerances
Agency. The Office of Management and
consensus standards pursuant to section
Budget (OMB) has exempted these types
12(d) of the National Technology AGENCY: Environmental Protection
of actions from review under Executive
Transfer and Advancement Act Agency (EPA).
Order 12866, entitled ‘‘Regulatory
(NTTAA) (15 U.S.C. 272 note). ACTION: Final rule.
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action VII. Congressional Review Act
has been exempted from review under SUMMARY: This regulation establishes
Pursuant to the Congressional Review tolerances for residues of
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, prothioconazole in or on cotton gin
submit a report containing this rule and byproducts and the cottonseed subgroup
entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect 20C. Bayer CropScience requested these
Senate, the U.S. House of tolerances under the Federal Food,
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
FR 28355, May 22, 2001) or Executive Drug, and Cosmetic Act (FFDCA).
General of the United States prior to
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal DATES: This regulation is effective
Children from Environmental Health Register. This action is not a ‘‘major November 10, 2016. Objections and
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). requests for hearings must be received
April 23, 1997). This action does not on or before January 9, 2017, and must
contain any information collections List of Subjects in 40 CFR Part 180 be filed in accordance with the
subject to OMB approval under the Environmental protection, instructions provided in 40 CFR part
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, 178 (see also Unit I.C. of the
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides SUPPLEMENTARY INFORMATION).
any special considerations under and pests, Reporting and recordkeeping ADDRESSES: The docket for this action,
Executive Order 12898, entitled requirements. identified by docket identification (ID)
‘‘Federal Actions to Address Dated: October 21, 2016. number EPA–HQ–OPP–2015–0722, is
Environmental Justice in Minority available at http://www.regulations.gov
Michael Goodis,
Populations and Low-Income or at the Office of Pesticide Programs
Acting Director, Registration Division, Office
Populations’’ (59 FR 7629, February 16, Regulatory Public Docket (OPP Docket)
of Pesticide Programs.
1994). in the Environmental Protection Agency
Since tolerances and exemptions that Therefore, 40 CFR chapter I is Docket Center (EPA/DC), West William
are established on the basis of a petition amended as follows: Jefferson Clinton Bldg., Rm. 3334, 1301
under FFDCA section 408(d), such as Constitution Ave. NW., Washington, DC
the tolerance in this final rule, do not PART 180—[AMENDED]
20460–0001. The Public Reading Room
require the issuance of a proposed rule, is open from 8:30 a.m. to 4:30 p.m.,
■ 1. The authority citation for part 180
the requirements of the Regulatory Monday through Friday, excluding legal
continues to read as follows:
Flexibility Act (RFA) (5 U.S.C. 601 et holidays. The telephone number for the
seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
Public Reading Room is (202) 566–1744,
This action directly regulates growers, ■ 2. In § 180.425, add alphabetically the and the telephone number for the OPP
food processors, food handlers, and food commodities ‘‘Asparagus’’ and Docket is (703) 305–5805. Please review
retailers, not States or tribes, nor does ‘‘Soybean, vegetable, succulent’’ to the the visitor instructions and additional
this action alter the relationships or table in paragraph (a) to read as follows: information about the docket available
distribution of power and at http://www.epa.gov/dockets.
responsibilities established by Congress § 180.425 Clomazone; tolerances for
in the preemption provisions of FFDCA residues. FOR FURTHER INFORMATION CONTACT:
asabaliauskas on DSK3SPTVN1PROD with RULES
section 408(n)(4). As such, the Agency (a) * * * Michael Goodis, Registration Division
has determined that this action will not (7505P), Office of Pesticide Programs,
have a substantial direct effect on States Parts per Environmental Protection Agency, 1200
Commodity
or tribal governments, on the million Pennsylvania Ave. NW., Washington,
relationship between the national DC 20460–0001; main telephone
Asparagus ................................... 0.05 number: (703) 305–7090; email address:
government and the States or tribal
governments, or on the distribution of * * * * *
RDFRNotices@epa.gov.
power and responsibilities among the Soybean, vegetable, succulent .. 0.05 SUPPLEMENTARY INFORMATION:
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Document Created: 2016-11-10 01:43:35
Document Modified: 2016-11-10 01:43:35
| 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 November 10, 2016. Objections and requests for hearings must be received on or before January 9, 2017, 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 | 81 FR 78913 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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