Clomazone; Pesticide Tolerances, 78913-78917 [2016-27201]

Download as PDF Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0712; FRL–9953–88] Clomazone; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: 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: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: asabaliauskas on DSK3SPTVN1PROD with RULES 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 VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–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 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 78913 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]-4,4dimethyl-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. . . .’’ E:\FR\FM\10NOR1.SGM 10NOR1 78914 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations 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 2generation 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-adverseeffect-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 asabaliauskas on DSK3SPTVN1PROD with RULES Exposure/scenario Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (General population including infants and children). An endpoint was not selected for the general population because no adverse 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 years of age). NOAEL = 100 mg/ kg/day. UFA = 10x ................ UFH = 10x ................ FQPA SF = 1x ......... VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 PO 00000 Acute RfD = 1.0 mg/ kg/day. aPAD = 1.0 mg/kg/ day. Frm 00016 Fmt 4700 Developmental Toxicity Study—Rats (MRID 00150291). LOAEL = 300 mg/kg/day based on indications of delayed ossification in the form of either partial ossification or the absence of the manubrium, sternebrae 3–4, xiphoid, caudal vertebrae, and meta-carpals. Sfmt 4700 E:\FR\FM\10NOR1.SGM 10NOR1 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 and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Chronic dietary (All populations) NOAEL= 84.4 mg/ kg/day. UFA = 10x ................ UFH = 10x ................ FQPA SF = 1x ......... Chronic RfD = 0.84 mg/kg/day. cPAD = 0.84 mg/kg/ day. Two Year Chronic Toxicity Study—Rats (MRID 00132586). NOAEL = 84.4/112.9 mg/kg/day, males/females (highest dose 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 premating, 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. Exposure/scenario asabaliauskas on DSK3SPTVN1PROD with RULES 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 VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 NHANES/WWEIA. As to residue levels in food, EPA incorporated tolerancelevel 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-[(2chlorophenyl)methyl]-3-hydroxy-2,2dimenthylpropanamide). 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-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 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 nonoccupational, 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 E:\FR\FM\10NOR1.SGM 10NOR1 78916 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES 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-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different 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: VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 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 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 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 shortor 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 shortand 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: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that E:\FR\FM\10NOR1.SGM 10NOR1 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Rules and Regulations EPA explain the reasons for departing from the Codex level. The Codex has not established any MRLs for clomazone. asabaliauskas on DSK3SPTVN1PROD with RULES V. Conclusion Therefore, tolerances are established for residues of clomazone, 2-[(2chlorophenyl)methyl]-4,4-dimethyl-3isoxazolidinone, 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 VerDate Sep<11>2014 16:33 Nov 09, 2016 Jkt 241001 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). Parts per million Commodity * * * * * * * 78917 * * * [FR Doc. 2016–27201 Filed 11–9–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0722; FRL–9953–71] Prothioconazole; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of prothioconazole in or on cotton gin byproducts and the cottonseed subgroup 20C. Bayer CropScience 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 List of Subjects in 40 CFR Part 180 be filed in accordance with the instructions provided in 40 CFR part Environmental protection, 178 (see also Unit I.C. of the Administrative practice and procedure, SUPPLEMENTARY INFORMATION). Agricultural commodities, Pesticides and pests, Reporting and recordkeeping ADDRESSES: The docket for this action, requirements. identified by docket identification (ID) number EPA–HQ–OPP–2015–0722, is Dated: October 21, 2016. available at http://www.regulations.gov Michael Goodis, or at the Office of Pesticide Programs Acting Director, Registration Division, Office Regulatory Public Docket (OPP Docket) of Pesticide Programs. in the Environmental Protection Agency Therefore, 40 CFR chapter I is Docket Center (EPA/DC), West William amended as follows: Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC PART 180—[AMENDED] 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., ■ 1. The authority citation for part 180 Monday through Friday, excluding legal continues to read as follows: holidays. The telephone number for the Authority: 21 U.S.C. 321(q), 346a and 371. Public Reading Room is (202) 566–1744, ■ 2. In § 180.425, add alphabetically the and the telephone number for the OPP commodities ‘‘Asparagus’’ and Docket is (703) 305–5805. Please review ‘‘Soybean, vegetable, succulent’’ to the the visitor instructions and additional table in paragraph (a) to read as follows: information about the docket available at http://www.epa.gov/dockets. § 180.425 Clomazone; tolerances for FOR FURTHER INFORMATION CONTACT: residues. Michael Goodis, Registration Division (a) * * * (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Parts per Commodity million Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone Asparagus ................................... 0.05 number: (703) 305–7090; email address: RDFRNotices@epa.gov. * * * * * Soybean, vegetable, succulent .. 0.05 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 SUMMARY: E:\FR\FM\10NOR1.SGM 10NOR1

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[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Rules and Regulations]
[Pages 78913-78917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27201]



[[Page 78913]]

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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.

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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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at 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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that

[[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