80 FR 9209 - Dimethenamid; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 34 (February 20, 2015)
Federal Register Volume 80, Issue 34 (February 20, 2015)
| Page Range | 9209-9215 | |
| FR Document | 2015-03458 |
[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)] [Rules and Regulations] [Pages 9209-9215] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03458] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2013-0670; FRL-9922-08] Dimethenamid; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of dimethenamid in or on cottonseed subgroup 20C and cotton, gin byproducts. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 20, 2015. Objections and requests for hearings must be received on or before April 21, 2015, 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-2013-0670, 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: Susan Lewis, 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 Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. [[Page 9210]] 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-2013-0670 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 21, 2015. 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-2013-0670, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of October 25, 2013 (78 FR 63938) (FRL- 9901-96), 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 3F8197) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.464 be amended by establishing tolerances for residues of the herbicide dimethenamid (1(RS)-2-chloro-N-[(1-methyl-2-methoxy)ethyl]-N- (2,4-dimethylthien-3-yl)acetamide) in or on cottonseed, subgroup 20C at 0.01 parts per million (ppm); cotton, gin byproducts at 1.5 ppm; and cotton, seed, refined oil at 0.02 ppm. Compliance with the tolerance levels is to be determined by measuring only parent. Tolerances would apply to either dimethenamid-P (a 90:10 mixture of S- and R-isomers, a mixture enriched in S-isomer) or dimethenamid (a 50:50 racemic mixture of S- and R-isomers). The enforcement method is not enantiomer specific. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, 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 determined that a separate tolerance in cotton, seed, and refined oil is not needed. The reason for these changes are explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for dimethenamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with dimethenamid 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 existing toxicological database is comprised of studies conducted with both dimethenamid, which is a racemic mixture of S- and R-isomers (50:50, S:R), and dimethenamid-P, which is mixture of S- and R-isomers enriched in the S-isomer (90:10, S:R). Both sets of data for dimethenamid and dimethenamid-P show similar toxicity and together are adequate for risk assessment. Because of the similarity of the two mixtures, EPA relies on data for both to assess the hazard of each mixture. The primary target organ is the liver. The toxicity in 90-day feeding studies in rats showed decreased body weights, increased cholesterol and changes in liver weights along with histopathology showing microscopic effects (centrilobular hypertrophy, periportal eosinophilic inclusions and necrosis) in the liver. Chronic studies in the rat, mouse, and dog showed decreases in body weight and food efficiency as accompanying effects over time. At higher dose levels, liver pathology (hepatic lesions, bile duct hyperplasia, and tumors), stomach hyperplasia, and some indications of kidney effects were noted. Two 21-day dermal toxicity studies in rabbits were conducted and in one of those studies minor skin irritation was observed at all doses tested and a decrease in body weight (bw) gain was also seen at the lowest effect level. The acute neurotoxicity study resulted in effects such as partially closed eyelids, lacrimation, and slight salivation at the highest dose tested of (600 milligrams/kilograms/body weight (mg/kg/bw)). There were no treatment-related or toxicologically significant findings during the gross examination of rats or in the microscopic examination of neurological tissues. In the subchronic neurotoxicity study, there were no clinical signs seen and no adverse effects seen up to 323/390 mg/kg/ bw day. Systemic effects seen were renal pelvic dilation in males (considered incidental) and a trend of higher liver weights in females was found at the lowest dose tested and [[Page 9211]] were not considered adverse nor were they corroborated with any other guideline studies submitted. There were no liver histopathology or clinical chemistry measurements in the subchronic neurotoxicity study; however, the adversity of this finding is supported by the observation of multiple liver effects (increased cholesterol, increased total serum protein, increased liver weights, and enlarged centrilobular hepatocytes) in the 90-day rat study at doses of 98/119 (Male/Female) milligrams/kilograms/day (mg/kg/day) and above. There was no neurotoxicity observed at higher doses nor in other guideline studies. Developmental toxicity studies show increased post-implantation loss and minor skeletal variations in the rat, and late resorptions and minor skeletal variations in the rabbit at the highest dose tested (lowest observed adverse effect level: LOAEL, 425 mg/kg/day). In the rabbit, the developmental effects occurred at the same dose as maternal toxicity (LOAEL, 150 mg/kg/day), whereas in the rat, the developmental toxicity occurred at much higher doses than in the dams (LOAEL, 215 mg/ kg/day). The chosen no observed adverse effect level (NOAEL) of 75 mg/ kg/day is considered protective for effects seen in both studies. The reproduction study resulted in decreases in body weight in both pups and parental animals at the same dose levels. The only other effects noted at the LOAEL of 150 mg/kg/day were increases in liver weights in both male and female parental animals. A review of the immunotoxicity study resulted in no immunotoxicity effects at the limit dose of 1,167 milligrams/kilograms (mg/kg), although increased absolute and relative liver weights were seen at this dose level. Dimethenamid-P is classified as group ``C'' possible human carcinogen, based on weak evidence for carcinogenicity. The agency concluded that quantification of cancer risk using a non-linear approach would adequately account for all chronic toxicity (including carcinogenicity) that could result from exposure to dimethenamid based on the following weight of evidence considerations: 1. No statistically significant increase in liver tumors (only an increasing trend for liver tumors in one sex (male) and one species (rat)). 2. No evidence of carcinogenicity in male or female mice. 3. Equivocal evidence for mutagenicity. 4. The POD of 5 mg/kg/day used for human health risk assessment is 15-fold lower than the dose (75 mg/kg/day) that caused the liver tumors and thus considered protective for cancer. Specific information on the studies received and the nature of the adverse effects caused as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document titled, ``Dimethenamid/Dimethenamid-P. Human Health Risk Assessment for Proposed New Use on Cottonseed Subgroup 20C.,'' on pg. 42-48, in docket ID number EPA-HQ-OPP-2013-0670. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological POD and levels of concern (LOC) 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 the NOAEL and the LOAEL are identified. 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 Dimethenamid/Dimethenamid-P used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Dimethenamid/Dimethenamid-P for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (General population NOAEL = 200 mg/kg/ Acute RfD = 2.0 mg/ Acute Neurotoxicity. including infants and children). day kg/day. LOAEL = 600 mg/kg/day based on UFA = 10x........... aPAD = 2.0 mg/kg/ lacrimation, salivation, UFH = 10x........... day. irregular and accelerated FQPA SF = 1x........ respiration, slight tremors, reduced exploration, unsteady gait, and significantly reduced rearing. ---------------------------------------------------------------------------------------------------------------- Acute dietary (Females 13-49 NOAEL = 75 mg/kg/day Acute RfD = 0.75 mg/ Developmental Rabbit Study years of age). UFA = 10x........... kg/day. Maternal. LOAEL = 150 mg/kg/day UFH = 10x........... aPAD = 0.75 mg/kg/ based on abortions (not FQPA SF = 1x........ day. considered acute effect). Developmental; LOAEL = 150 mg/kg/ day based on post-implantation loss. ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL = 5 mg/kg/day Chronic RfD = 0.05 Chronic/Carcinogenicity Rat Study. UFA = 10x........... mg/kg/day. LOAEL = Male/Female; 36/49 mg/kg/ UFH = 10x........... cPAD = 0.05 mg/kg/ day based on decreased body FQPA SF = 1x........ day. weight and body weight gain in both sexes, increased food conversion ratios in females, and increased microscopic hepatic lesions in both sexes. ---------------------------------------------------------------------------------------------------------------- [[Page 9212]] Incidental oral short-term and NOAEL = 10 mg/kg/day LOC for MOE = 100.. Subchronic/Chronic Oral Dog intermediate-term (1 to 6 UFA = 10x........... Studies. months). UFH = 10x........... Chronic NOAEL = 10 mg/kg/day. FQPA SF = 1x........ Chronic LOAEL = 48.7 mg/kg/day. Subchronic NOAEL = 4.72 mg/kg/day. Subchronic LOAEL = 33.6 mg/kg/day based on decreased body weight in females, increased relative to body liver weight in both sexes, increased periportal cytoplasmic vacuolation in liver in both sexes, and dilation of liver sinusoids in females. ---------------------------------------------------------------------------------------------------------------- Dermal short-term (1 to 30 days) NOAEL = 300 mg/kg/ LOC for MOE = 100.. 21-Day Dermal Rabbit Study. and intermediate-term (1-6 day LOAEL = 500 mg/kg/day based on months). UFA = 10x........... decreased body weight gain only UFH = 10x........... (non-specific). FQPA SF = 1x........ ---------------------------------------------------------------------------------------------------------------- Inhalation short-term (1 to 30 NOAEL = 10 mg/kg/day LOC for MOE= 100... Subchronic/Chronic Oral Dog days). UFA = 10x........... Studies. UFH = 10x........... Chronic NOAEL = 10 mg/kg/day. FQPA SF = 1x........ Chronic LOAEL = 48.7 mg/kg/day. Subchronic NOAEL = 4.72 mg/kg/day. Subchronic LOAEL = 33.6 mg/kg/day based on decreased body weight in females, increased relative to body liver weight in both sexes, increased periportal cytoplasmic vacuolation in liver in both sexes, and dilation of liver sinusoids in females. ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) ``C'' Possible human carcinogen. The chronic RfD is considered protective of the cancer effects. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect- level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. 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 dimethenamid-P and/or dimethenamid, EPA considered exposure under the petitioned-for tolerances as well as all existing dimethenamid tolerances in 40 CFR 180.464 which are established for either of the herbicides dimethenamid-P (an enriched S-isomer with 90:10 mixture of the S- and R-isomers) or dimethenamid (a 50:50 racemic mixture of the S- and R-isomers). Therefore, EPA assessed dietary exposures from dimethenamid-P and/or dimethenamid 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 dimethenamid and dimethenamid-P. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). The acute dietary analysis was conducted for dimethenamid and/or dimethenamid-P assuming tolerance level residues, default processing factors, and 100% crop treated (CT) information. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 CSFII. The chronic dietary exposure assessment was conducted for dimethenamid and/or dimethenamid-P assuming tolerance level residues, default processing factors, and 100% CT information. iii. Cancer. As discussed in Unit III.A, EPA has concluded that cancer dietary risk concerns due to long-term consumption of dimethenamid residues are adequately addressed by the chronic dietary exposure analysis using the reference dose; therefore, a separate cancer dietary exposure analysis was not performed. iv. Anticipated residue and percent crop treated (PCT) information. Tolerance level residues and 100% CT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for dimethenamid-P and/or dimethenamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of dimethenamid-P and/or dimethenamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm. Based on the Surface Water Concentration Calculator (SWCC) and the Pesticide Root Zone Model for Ground Water (PRZM-GW), estimated drinking water concentrations (EDWCs) were calculated for the parent compound plus its ethanesulfonic acid and oxanilic acid degradates, which are residues of concern in drinking water as follows: For acute exposures, EDWCs are estimated to be 73 parts per billion (ppb) for surface water and 153 ppb for ground water; for chronic exposures, EDWCs for non-cancer assessments are estimated to be 27 ppb for surface water and 140 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. [[Page 9213]] Because there was little difference between the maximum EDWCs for acute and chronic exposures, the maximum water concentration value of 153 ppb was used to assess the contribution to drinking water for both the acute and chronic dietary risk assessments. 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). Although there are no currently registered uses of dimethenamid that could result in residential exposures, dimethenamid-P is currently registered for the following uses that could result in residential exposures: Turf grass, ornamentals, and tree plantations. Only short-term residential exposures to dimethenamid-P are expected based on the 2012 Residential Standard Operating Procedures (SOPs). Potential exposure/risk scenarios identified for residential handlers include: Mixing/loading/applying liquid formulations to lawns/turf with a hose-end and/or backpack sprayer, and a manually-pressurized hand wand. Mixing/loading/applying liquid formulations to garden/ trees with a sprinkler can and a hose-end sprayer. Mixing/loading/applying granular formulations to lawns/ turf with a push-type rotary sprayer and a belly grinder. Mixing/loading/applying granular formulations to garden/ trees with a shaker can/cup, a spoon or by hand dispersal. The scenarios, routes of exposure, and lifestages of potential post-application exposure include: Physical activities on turf: Adults (dermal) and children 1 to <2 years old (dermal and incidental oral). Mowing: Adults (dermal) and children 11 to <16 years old (dermal). Golfing: Adults (dermal), children 11 to <16 years old (dermal), and children 6 to <11 years old (dermal). Contact with Treated Gardens and Trees: Adults (dermal) and children 6 to <11 years old (dermal). The values used for aggregate assessment are based on the worst-case residential exposure estimates via the inhalation (adult male) and oral (child 1 < 2 years old) routes. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found that dimethenamid-P and dimethenamid share a common mechanism of toxicity with any other substances, or that they appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that dimethenamid-P and dimethenamid do 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://www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There is no concern for increased qualitative and/or quantitative susceptibility following in utero (rats and rabbits) and pre-and post-natal exposure (rats). The NOAEL and LOAEL values for the fetal/pup effects observed in the developmental study and effects seen in the reproduction studies occurred at the same doses or higher than those which caused maternal toxicity. The rabbit developmental study was used as an acute dietary endpoint for females 13-49 years of age. The POD selected for risk assessment are protective of effects seen in these guideline studies. Therefore, the acute and chronic dietary risk assessments are protective of potential fetal/offspring effects. 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA SF to 1X. That decision is based on the following findings: i. The toxicity database for dimethenamid and dimethenamid-P is complete. ii. There is no indication that dimethenamid or dimethenamid-P is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that dimethenamid or dimethenamid-P results in increased susceptibility in utero in rat or rabbit prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues which results in very high-end estimates of dietary exposure. The dietary drinking water assessment, which included parent plus its ethanesulfonic acid and oxanilic acid degradates, utilizes values generated by model and associated modeling parameters which are designed to provide health protective, high-end estimates of water concentrations. These assessments will not underestimate the exposure and risks posed by dimethenamid-P and/or dimethenamid residues of concern. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to dimethenamid-P and/or dimethenamid residues of concern will occupy 1.3% of the aPAD for infants <1 year of age, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to dimethenamid-P and dimethenamid residues of concern from food and water will utilize 17% of the cPAD for infants <1 year of [[Page 9214]] age, the population group receiving the greatest exposure. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Dimethenamid- P is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to dimethenamid-P. Dermal and inhalation exposures to handlers were not aggregated because the toxicity endpoints for these exposure routes are not based on common toxicity effects in/of the liver. Dermal effects (bw gain) were considered to be non-specific. EPA aggregated the worst-case residential exposure estimates via the inhalation (adult male) and oral (child 1 < 2 years old) routes. Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOEs of 2,200 for adults and 1,100 for children 1-2 years old. Because EPA's LOC for dimethenamid-P is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, dimethenamid-P is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for dimethenamid-P. 5. Aggregate cancer risk for U.S. population. As indicated in Unit III.A., EPA has concluded that the chronic RfD would be protective of any cancer effects. Based on the results of the chronic aggregate risk assessment, EPA concludes there is no risk of concern for cancer effects from exposure to dimethenamid and dimethenamid-P. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to dimethenamid and dimethenamid-P residues of concern. IV. Other Considerations A. Analytical Enforcement Methodology An adequate enforcement method is available for determining residues of dimethenamid in plant commodities. The Gas Chromatography/ Nitrogen-Phosphorus Detector (GC/NPD) method (AM-0884-0193-1) has been validated by the Agency and submitted for publication in the Food and Drug Administration (FDA) Pesticide Analytical Manual (PAM), Volume II. The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) is 0.01 ppm. This method is not enantiomer specific. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for dimethenamid or dimethenamid-P in/on members of cottonseed subgroup 20C and cotton, gin byproducts. C. Revisions to Petitioned-For Tolerances A separate tolerance in cotton, seed, refined oil is not needed since the exaggerated rate processing study demonstrates that the petitioned-for tolerance in/on cottonseed subgroup 20C (0.01 ppm) will be adequate to cover potential residues of dimethenamid in refined oil. V. Conclusion Therefore, tolerances are established for residues of the herbicide dimethenamid, 1(RS)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2, 4- dimethylthien-3-yl) acetamide, applied as either the 90:10 or 50:50 S:R isomers, in or on cottonseed subgroup 20C at 0.01 ppm and cotton, gin byproducts at 1.5 ppm. VI. Statutory and Executive Order Reviews This final rule 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 final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule 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 final rule 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 [[Page 9215]] 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (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: February 10, 2015. Susan Lewis, 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. 180.464, add alphabetically the following commodities to the table in paragraph (a) to read as follows: Sec. 180.464 Dimethenamid; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Cotton, gin byproducts.................................. 1.5 Cottonseed subgroup 20C................................. 0.01 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-03458 Filed 2-19-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 9209
Subpart AA—Missouri Charles, and St. Louis Counties along Authority: 42 U.S.C. 7401, et seq.
with the City of St. Louis. As part of the
■ 2. Section 52.1342 is amended by redesignation request, the State Subpart C—Section 107 Attainment
adding paragraph (c) to read as follows: submitted a plan for maintaining the Status Designations
§ 52.1342 Control strategy: Ozone.
1997 8-hour ozone standard through
2025 in the area as required by Section ■ 4. Section 81.326 is amended by
* * * * * 175A of the Clean Air Act. revising the entry for ‘‘St. Louis MO–IL’’
(c) On November 3, 2011 and April
in the table entitled ‘‘Missouri—1997 8-
29, 2014, Missouri submitted requests to PART 81—DESIGNATION OF AREAS
redesignate the Missouri portion of the Hour Ozone NAAQS (Primary and
FOR AIR QUALITY PLANNING Secondary)’’ to read as follows:
St. Louis MO–IL area to attainment of PURPOSES
the 1997 8-hour ozone standard. The § 81.326 Missouri.
Missouri portion of the St. Louis MO– ■ 3. The authority citation for part 81
IL area includes Jefferson, Franklin, St. continues to read as follows: * * * * *
MISSOURI—1997 8-HOUR OZONE NAAQS
[Primary and Secondary]
Designation a Category/Classification
Designated area
Date 1 Type Date 1 Type
* * * * * * *
St. Louis, MO–IL
Franklin County .......................... February 20, 2015 ...................... Attainment.
Jefferson County ........................ February 20, 2015 ...................... Attainment.
St. Charles County ..................... February 20, 2015 ...................... Attainment.
St. Louis City .............................. February 20, 2015 ...................... Attainment.
St. Louis County ......................... February 20, 2015 ...................... Attainment.
* * * * * * *
a Includes Indian Country located in each county or area, except as otherwise specified.
1 This date is June 15, 2004, unless otherwise noted.
* * * * * ADDRESSES: The docket for this action, I. General Information
[FR Doc. 2015–03287 Filed 2–19–15; 8:45 am] identified by docket identification (ID)
A. Does this action apply to me?
BILLING CODE 6560–50–P number EPA–HQ–OPP–2013–0670, is
available at http://www.regulations.gov You may be potentially affected by
or at the Office of Pesticide Programs this action if you are an agricultural
ENVIRONMENTAL PROTECTION Regulatory Public Docket (OPP Docket) producer, food manufacturer, or
AGENCY in the Environmental Protection Agency pesticide manufacturer. The following
40 CFR Part 180 Docket Center (EPA/DC), West William list of North American Industrial
Jefferson Clinton Bldg., Rm. 3334, 1301 Classification System (NAICS) codes is
Constitution Ave. NW., Washington, DC not intended to be exhaustive, but rather
[EPA–HQ–OPP–2013–0670; FRL–9922–08] provides a guide to help readers
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., determine whether this document
Dimethenamid; Pesticide Tolerances
Monday through Friday, excluding legal applies to them. Potentially affected
AGENCY: Environmental Protection holidays. The telephone number for the entities may include:
Agency (EPA). Public Reading Room is (202) 566–1744, • Crop production (NAICS code 111).
ACTION: Final rule. and the telephone number for the OPP • Animal production (NAICS code
Docket is (703) 305–5805. Please review 112).
SUMMARY: This regulation establishes the visitor instructions and additional
tolerances for residues of dimethenamid • Food manufacturing (NAICS code
information about the docket available 311).
in or on cottonseed subgroup 20C and at http://www.epa.gov/dockets.
cotton, gin byproducts. BASF • Pesticide manufacturing (NAICS
Corporation requested these tolerances FOR FURTHER INFORMATION CONTACT: code 32532).
under the Federal Food, Drug, and Susan Lewis, Registration Division
Cosmetic Act (FFDCA). (7505P), Office of Pesticide Programs, B. How can I get electronic access to
Environmental Protection Agency, 1200 other related information?
DATES: This regulation is effective
Pennsylvania Ave. NW., Washington,
Rmajette on DSK2VPTVN1PROD with RULES
February 20, 2015. Objections and You may access a frequently updated
requests for hearings must be received DC 20460–0001; main telephone electronic version of EPA’s tolerance
on or before April 21, 2015, and must number: (703) 305–7090; email address: regulations at 40 CFR part 180 through
be filed in accordance with the RDFRNotices@epa.gov. the Government Publishing Office’s e-
instructions provided in 40 CFR part SUPPLEMENTARY INFORMATION:
CFR site at http://www.ecfr.gov/cgi-bin/
178 (see also Unit I.C. of the text-idx?&c=ecfr&tpl=/ecfrbrowse/
SUPPLEMENTARY INFORMATION). Title40/40tab_02.tpl.
VerDate Sep<11>2014 21:59 Feb 19, 2015 Jkt 235001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\20FER1.SGM 20FER1](https://thefederalregister.org/doc/80_FR_9243/page/1.svg)
![9210 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations
C. How can I file an objection or hearing 27709–3528. The petition requested that tolerances established by this action.
request? 40 CFR 180.464 be amended by EPA’s assessment of exposures and risks
Under FFDCA section 408(g), 21 establishing tolerances for residues of associated with dimethenamid follows.
U.S.C. 346a, any person may file an the herbicide dimethenamid (1(RS)-2-
A. Toxicological Profile
objection to any aspect of this regulation chloro-N-[(1-methyl-2-methoxy)ethyl]-
N-(2,4-dimethylthien-3-yl)acetamide) in EPA has evaluated the available
and may also request a hearing on those toxicity data and considered its validity,
objections. You must file your objection or on cottonseed, subgroup 20C at 0.01
parts per million (ppm); cotton, gin completeness, and reliability as well as
or request a hearing on this regulation the relationship of the results of the
byproducts at 1.5 ppm; and cotton, seed,
in accordance with the instructions studies to human risk. EPA has also
refined oil at 0.02 ppm. Compliance
provided in 40 CFR part 178. To ensure considered available information
with the tolerance levels is to be
proper receipt by EPA, you must concerning the variability of the
determined by measuring only parent.
identify docket ID number EPA–HQ– sensitivities of major identifiable
Tolerances would apply to either
OPP–2013–0670 in the subject line on subgroups of consumers, including
dimethenamid-P (a 90:10 mixture of S-
the first page of your submission. All infants and children.
and R-isomers, a mixture enriched in S-
objections and requests for a hearing The existing toxicological database is
isomer) or dimethenamid (a 50:50
must be in writing, and must be comprised of studies conducted with
racemic mixture of S- and R-isomers).
received by the Hearing Clerk on or The enforcement method is not both dimethenamid, which is a racemic
before April 21, 2015. Addresses for enantiomer specific. That document mixture of S- and R-isomers (50:50, S:R),
mail and hand delivery of objections referenced a summary of the petition and dimethenamid-P, which is mixture
and hearing requests are provided in 40 prepared by BASF Corporation, the of S- and R-isomers enriched in the S-
CFR 178.25(b). registrant, which is available in the isomer (90:10, S:R). Both sets of data for
In addition to filing an objection or docket, http://www.regulations.gov. dimethenamid and dimethenamid-P
hearing request with the Hearing Clerk There were no comments received in show similar toxicity and together are
as described in 40 CFR part 178, please response to the notice of filing. adequate for risk assessment. Because of
submit a copy of the filing (excluding Based upon review of the data the similarity of the two mixtures, EPA
any Confidential Business Information supporting the petition, EPA has relies on data for both to assess the
(CBI)) for inclusion in the public docket. determined that a separate tolerance in hazard of each mixture.
Information not marked confidential cotton, seed, and refined oil is not The primary target organ is the liver.
pursuant to 40 CFR part 2 may be needed. The reason for these changes The toxicity in 90-day feeding studies in
disclosed publicly by EPA without prior are explained in Unit IV.C. rats showed decreased body weights,
notice. Submit the non-CBI copy of your increased cholesterol and changes in
objection or hearing request, identified III. Aggregate Risk Assessment and liver weights along with histopathology
by docket ID number EPA–HQ–OPP– Determination of Safety showing microscopic effects
2013–0670, by one of the following Section 408(b)(2)(A)(i) of FFDCA (centrilobular hypertrophy, periportal
methods: allows EPA to establish a tolerance (the eosinophilic inclusions and necrosis) in
• Federal eRulemaking Portal: http:// legal limit for a pesticide chemical the liver. Chronic studies in the rat,
www.regulations.gov. Follow the online residue in or on a food) only if EPA mouse, and dog showed decreases in
instructions for submitting comments. determines that the tolerance is ‘‘safe.’’ body weight and food efficiency as
Do not submit electronically any Section 408(b)(2)(A)(ii) of FFDCA accompanying effects over time. At
information you consider to be CBI or defines ‘‘safe’’ to mean that ‘‘there is a higher dose levels, liver pathology
other information whose disclosure is reasonable certainty that no harm will (hepatic lesions, bile duct hyperplasia,
restricted by statute. result from aggregate exposure to the and tumors), stomach hyperplasia, and
• Mail: OPP Docket, Environmental pesticide chemical residue, including some indications of kidney effects were
Protection Agency Docket Center (EPA/ all anticipated dietary exposures and all noted. Two 21-day dermal toxicity
DC), (28221T), 1200 Pennsylvania Ave. other exposures for which there is studies in rabbits were conducted and
NW., Washington, DC 20460–0001. reliable information.’’ This includes in one of those studies minor skin
• Hand Delivery: To make special exposure through drinking water and in irritation was observed at all doses
arrangements for hand delivery or residential settings, but does not include tested and a decrease in body weight
delivery of boxed information, please occupational exposure. Section (bw) gain was also seen at the lowest
follow the instructions at 408(b)(2)(C) of FFDCA requires EPA to effect level.
http://www.epa.gov/dockets/ give special consideration to exposure The acute neurotoxicity study
contacts.html. of infants and children to the pesticide resulted in effects such as partially
Additional instructions on chemical residue in establishing a closed eyelids, lacrimation, and slight
commenting or visiting the docket, tolerance and to ‘‘ensure that there is a salivation at the highest dose tested of
along with more information about reasonable certainty that no harm will (600 milligrams/kilograms/body weight
dockets generally, is available at http:// result to infants and children from (mg/kg/bw)). There were no treatment-
www.epa.gov/dockets. aggregate exposure to the pesticide related or toxicologically significant
chemical residue. . . .’’ findings during the gross examination of
II. Summary of Petitioned-For Consistent with FFDCA section rats or in the microscopic examination
Tolerance 408(b)(2)(D), and the factors specified in of neurological tissues. In the
In the Federal Register of October 25, FFDCA section 408(b)(2)(D), EPA has subchronic neurotoxicity study, there
Rmajette on DSK2VPTVN1PROD with RULES
2013 (78 FR 63938) (FRL–9901–96), reviewed the available scientific data were no clinical signs seen and no
EPA issued a document pursuant to and other relevant information in adverse effects seen up to 323/390 mg/
FFDCA section 408(d)(3), 21 U.S.C. support of this action. EPA has kg/bw day. Systemic effects seen were
346a(d)(3), announcing the filing of a sufficient data to assess the hazards of renal pelvic dilation in males
pesticide petition (PP 3F8197) by BASF and to make a determination on (considered incidental) and a trend of
Corporation, 26 Davis Drive, P.O. Box aggregate exposure for dimethenamid higher liver weights in females was
13528, Research Triangle Park, NC including exposure resulting from the found at the lowest dose tested and
VerDate Sep<11>2014 12:44 Feb 19, 2015 Jkt 235001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\20FER1.SGM 20FER1](https://thefederalregister.org/doc/80_FR_9243/page/2.svg)
![9214 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations
age, the population group receiving the cancer effects from exposure to V. Conclusion
greatest exposure. dimethenamid and dimethenamid-P. Therefore, tolerances are established
3. Short-term risk. Short-term 6. Determination of safety. Based on for residues of the herbicide
aggregate exposure takes into account these risk assessments, EPA concludes dimethenamid, 1(RS)-2-chloro-N-[(1-
short-term residential exposure plus that there is a reasonable certainty that methyl-2-methoxy) ethyl]-N-(2, 4-
chronic exposure to food and water no harm will result to the general dimethylthien-3-yl) acetamide, applied
(considered to be a background population, or to infants and children as either the 90:10 or 50:50 S:R isomers,
exposure level). Dimethenamid-P is from aggregate exposure to in or on cottonseed subgroup 20C at
currently registered for uses that could dimethenamid and dimethenamid-P 0.01 ppm and cotton, gin byproducts at
result in short-term residential residues of concern. 1.5 ppm.
exposure, and the Agency has
determined that it is appropriate to IV. Other Considerations VI. Statutory and Executive Order
aggregate chronic exposure through food A. Analytical Enforcement Methodology Reviews
and water with short-term residential This final rule establishes tolerances
exposures to dimethenamid-P. An adequate enforcement method is under FFDCA section 408(d) in
Dermal and inhalation exposures to available for determining residues of response to a petition submitted to the
handlers were not aggregated because dimethenamid in plant commodities. Agency. The Office of Management and
the toxicity endpoints for these The Gas Chromatography/Nitrogen- Budget (OMB) has exempted these types
exposure routes are not based on Phosphorus Detector (GC/NPD) method of actions from review under Executive
common toxicity effects in/of the liver. (AM–0884–0193–1) has been validated Order 12866, entitled ‘‘Regulatory
Dermal effects (bw gain) were by the Agency and submitted for Planning and Review’’ (58 FR 51735,
considered to be non-specific. EPA publication in the Food and Drug October 4, 1993). Because this final rule
aggregated the worst-case residential Administration (FDA) Pesticide has been exempted from review under
exposure estimates via the inhalation Analytical Manual (PAM), Volume II. Executive Order 12866, this final rule is
(adult male) and oral (child 1 < 2 years The limit of quantitation (LOQ; not subject to Executive Order 13211,
old) routes. determined as the lowest level of entitled ‘‘Actions Concerning
Using the exposure assumptions method validation, LLMV) is 0.01 ppm. Regulations That Significantly Affect
described in this unit for short-term This method is not enantiomer specific. Energy Supply, Distribution, or Use’’ (66
exposures, EPA has concluded the B. International Residue Limits FR 28355, May 22, 2001) or Executive
combined short-term food, water, and Order 13045, entitled ‘‘Protection of
residential exposures result in an In making its tolerance decisions, EPA Children from Environmental Health
aggregate MOEs of 2,200 for adults and seeks to harmonize U.S. tolerances with Risks and Safety Risks’’ (62 FR 19885,
1,100 for children 1–2 years old. international standards whenever April 23, 1997). This final rule does not
Because EPA’s LOC for dimethenamid- possible, consistent with U.S. food contain any information collections
P is a MOE of 100 or below, these MOEs safety standards and agricultural subject to OMB approval under the
are not of concern. practices. EPA considers the Paperwork Reduction Act (PRA) (44
4. Intermediate-term risk. international maximum residue limits U.S.C. 3501 et seq.), nor does it require
Intermediate-term aggregate exposure (MRLs) established by the Codex any special considerations under
takes into account intermediate-term Alimentarius Commission (Codex), as Executive Order 12898, entitled
residential exposure plus chronic required by FFDCA section 408(b)(4). ‘‘Federal Actions to Address
exposure to food and water (considered The Codex Alimentarius is a joint Environmental Justice in Minority
to be a background exposure level). An United Nations Food and Agriculture Populations and Low-Income
intermediate-term adverse effect was Organization/World Health Populations’’ (59 FR 7629, February 16,
identified; however, dimethenamid-P is Organization food standards program, 1994).
not registered for any use patterns that and it is recognized as an international Since tolerances and exemptions that
would result in intermediate-term food safety standards-setting are established on the basis of a petition
residential exposure. Intermediate-term organization in trade agreements to under FFDCA section 408(d), such as
risk is assessed based on intermediate- which the United States is a party. EPA the tolerance in this final rule, do not
term residential exposure plus chronic may establish a tolerance that is require the issuance of a proposed rule,
dietary exposure. Because there is no different from a Codex MRL; however, the requirements of the Regulatory
intermediate-term residential exposure FFDCA section 408(b)(4) requires that Flexibility Act (RFA) (5 U.S.C. 601 et
and chronic dietary exposure has EPA explain the reasons for departing seq.), do not apply.
already been assessed under the from the Codex level. This final rule directly regulates
appropriately protective cPAD (which is The Codex has not established a MRL growers, food processors, food handlers,
at least as protective as the POD used to for dimethenamid or dimethenamid-P and food retailers, not States or tribes,
assess intermediate-term risk), no in/on members of cottonseed subgroup nor does this action alter the
further assessment of intermediate-term 20C and cotton, gin byproducts. relationships or distribution of power
risk is necessary, and EPA relies on the C. Revisions to Petitioned-For and responsibilities established by
chronic dietary risk assessment for Tolerances Congress in the preemption provisions
evaluating intermediate-term risk for of FFDCA section 408(n)(4). As such,
dimethenamid-P. A separate tolerance in cotton, seed, the Agency has determined that this
Rmajette on DSK2VPTVN1PROD with RULES
5. Aggregate cancer risk for U.S. refined oil is not needed since the action will not have a substantial direct
population. As indicated in Unit III.A., exaggerated rate processing study effect on States or tribal governments,
EPA has concluded that the chronic RfD demonstrates that the petitioned-for on the relationship between the national
would be protective of any cancer tolerance in/on cottonseed subgroup government and the States or tribal
effects. Based on the results of the 20C (0.01 ppm) will be adequate to governments, or on the distribution of
chronic aggregate risk assessment, EPA cover potential residues of power and responsibilities among the
concludes there is no risk of concern for dimethenamid in refined oil. various levels of government or between
VerDate Sep<11>2014 12:44 Feb 19, 2015 Jkt 235001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\20FER1.SGM 20FER1](https://thefederalregister.org/doc/80_FR_9243/page/6.svg)
![Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 9215
the Federal Government and Indian * * * * * Pennsylvania Ave. NW., Washington,
tribes. Thus, the Agency has determined [FR Doc. 2015–03458 Filed 2–19–15; 8:45 am] DC 20460–0001; main telephone
that Executive Order 13132, entitled BILLING CODE 6560–50–P number: (703) 305–7090; email address:
‘‘Federalism’’ (64 FR 43255, August 10, BPPDFRNotices@epa.gov.
1999) and Executive Order 13175, SUPPLEMENTARY INFORMATION:
entitled ‘‘Consultation and Coordination ENVIRONMENTAL PROTECTION
with Indian Tribal Governments’’ (65 FR AGENCY I. General Information
67249, November 9, 2000) do not apply A. Does this action apply to me?
to this final rule. In addition, this final 40 CFR Part 180
You may be potentially affected by
rule does not impose any enforceable [EPA–HQ–OPP–2013–0574; FRL–9920–62]
this action if you are an agricultural
duty or contain any unfunded mandate
Bacillus Subtilis Strain IAB/BS03; producer, food manufacturer, or
as described under Title II of the
Exemption From the Requirement of a pesticide manufacturer. The following
Unfunded Mandates Reform Act of 1995
Tolerance list of North American Industrial
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any Classification System (NAICS) codes is
AGENCY: Environmental Protection not intended to be exhaustive, but rather
technical standards that would require Agency (EPA).
Agency consideration of voluntary provides a guide to help readers
ACTION: Final rule. determine whether this document
consensus standards pursuant to section
12(d) of the National Technology applies to them. Potentially affected
This regulation establishes an
SUMMARY:
Transfer and Advancement Act of 1995 entities may include:
exemption from the requirement of a
(NTTAA) (15 U.S.C. 272 note). • Crop production (NAICS code 111).
tolerance for residues of the fungicide
• Animal production (NAICS code
VII. Congressional Review Act Bacillus subtilis strain IAB/BS03 in or
112).
on all food commodities when used in
Pursuant to the Congressional Review accordance with label directions and • Food manufacturing (NAICS code
Act (5 U.S.C. 801 et seq.), EPA will 311).
good agricultural practices.
submit a report containing this rule and Investigaciones y Aplicaciones • Pesticide manufacturing (NAICS
other required information to the U.S. code 32532).
Biotechnologicas (IAB, S.L.) submitted a
Senate, the U.S. House of petition to EPA under the Federal Food, B. How can I get electronic access to
Representatives, and the Comptroller Drug, and Cosmetic Act (FFDCA), other related information?
General of the United States prior to requesting an exemption from the
publication of the rule in the Federal You may access a frequently updated
requirement of a tolerance. This electronic version of 40 CFR part 180
Register. This action is not a ‘‘major regulation eliminates the need to
rule’’ as defined by 5 U.S.C. 804(2). through the Government Publishing
establish a maximum permissible level
Office’s e-CFR site at http://
List of Subjects in 40 CFR Part 180 for residues of Bacillus subtilis strain
www.ecfr.gov/cgi-bin/text-
IAB/BS03.
Environmental protection, idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
DATES: This regulation is effective 40tab_02.tpl.
Administrative practice and procedure,
February 20, 2015. Objections and
Agricultural commodities, Pesticides requests for hearings must be received C. How can I file an objection or hearing
and pests, Reporting and recordkeeping on or before April 21, 2015, and must request?
requirements. be filed in accordance with the Under FFDCA section 408(g), 21
Dated: February 10, 2015. instructions provided in 40 CFR part U.S.C. 346a(g), any person may file an
Susan Lewis, 178 (see also Unit I.C. of the objection to any aspect of this regulation
Director, Registration Division, Office of SUPPLEMENTARY INFORMATION). and may also request a hearing on those
Pesticide Programs. ADDRESSES: The docket for this action, objections. You must file your objection
Therefore, 40 CFR chapter I is identified by docket identification (ID) or request a hearing on this regulation
amended as follows: number EPA–HQ–OPP–2013–0574 is in accordance with the instructions
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure
PART 180—[AMENDED] or at the Office of Pesticide Programs proper receipt by EPA, you must
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ–
■ 1. The authority citation for part 180
in the Environmental Protection Agency OPP–2013–0574 in the subject line on
continues to read as follows:
Docket Center (EPA/DC), West William the first page of your submission. All
Authority: 21 U.S.C. 321(q), 346a and 371. Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
■ 2. In § 180.464, add alphabetically the Constitution Ave. NW., Washington, DC must be in writing, and must be
following commodities to the table in 20460–0001. The Public Reading Room received by the Hearing Clerk on or
paragraph (a) to read as follows: is open from 8:30 a.m. to 4:30 p.m., before April 21, 2015. Addresses for
Monday through Friday, excluding legal mail and hand delivery of objections
§ 180.464 Dimethenamid; tolerances for holidays. The telephone number for the
residues.
and hearing requests are provided in 40
Public Reading Room is (202) 566–1744, CFR 178.25(b).
(a) * * * and the telephone number for the OPP In addition to filing an objection or
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
Parts per
Commodity million the visitor instructions and additional as described in 40 CFR part 178, please
Rmajette on DSK2VPTVN1PROD with RULES
information about the docket available submit a copy of the filing (excluding
at http://www.epa.gov/dockets. any Confidential Business Information
* * * * * FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket.
Cotton, gin byproducts ......... 1.5 Robert McNally, Biopesticides and Information not marked confidential
Cottonseed subgroup 20C ... 0.01 Pollution Prevention Division (7511P), pursuant to 40 CFR part 2 may be
* * * * * Office of Pesticide Programs, disclosed publicly by EPA without prior
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
VerDate Sep<11>2014 21:59 Feb 19, 2015 Jkt 235001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\20FER1.SGM 20FER1](https://thefederalregister.org/doc/80_FR_9243/page/7.svg)
Document Created: 2015-12-18 13:02:04
Document Modified: 2015-12-18 13:02:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective February 20, 2015. Objections and requests for hearings must be received on or before April 21, 2015, 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 | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 80 FR 9209 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR