5704 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations

Parts per DATES: This regulation is effective Industrial Classification System Commodity million February 2, 2011. Objections and (NAICS) codes have been provided to requests for hearings must be received assist you and others in determining ***** on or before April 4, 2011, and must be whether this action might apply to Fruit, citrus, group 10 ...... 0 .03 filed in accordance with the instructions certain entities. If you have any questions regarding the applicability of ***** provided in 40 CFR part 178 (see also Grape ...... 0 .01 Unit I.C. of the SUPPLEMENTARY this action to a particular entity, consult INFORMATION). the person listed under FOR FURTHER INFORMATION CONTACT. ***** ADDRESSES: EPA has established a 1 Potato ...... 1.0 docket for this action under docket B. How can I get electronic access to Potato, chips1 ...... 2.0 Potato, granules/flakes1 ...... 4 .0 identification (ID) number EPA–HQ– other related information? OPP–2008–0125. All documents in the You may access a frequently updated ***** docket are listed in the docket index electronic version of EPA’s tolerance available at http://www.regulations.gov. 1 No U.S. registrations. regulations at 40 CFR part 180 through Although listed in the index, some the Government Printing Office’s e-CFR * * * * * information is not publicly available, site at http://www.gpoaccess.gov/ecfr. (c) Tolerances with regional e.g., Confidential Business Information registrations. Tolerances with regional (CBI) or other information whose C. How can I file an objection or hearing registrations are established for residues disclosure is restricted by statute. request? of the herbicide fluazifop-P-butyl, Certain other material, such as Under FFDCA section 408(g), 21 including its metabolites and copyrighted material, is not placed on U.S.C. 346a, any person may file an degradates, in or on the following the Internet and will be publicly objection to any aspect of this regulation commodities in the table. Compliance available only in hard copy form. and may also request a hearing on those with the tolerance levels specified in the Publicly available docket materials are objections. You must file your objection table below is to be determined by available in the electronic docket at or request a hearing on this regulation measuring only the sum of fluazifop-P- http://www.regulations.gov, or, if only in accordance with the instructions butyl, butyl(R)-2-[4-[[5- available in hard copy, at the OPP provided in 40 CFR part 178. To ensure (trifluoromethyl)-2- Regulatory Public Docket in Rm. S– proper receipt by EPA, you must pyridinyl]oxy]phenoxy]propanoate, and 4400, One Potomac Yard (South Bldg.), identify docket ID number EPA–HQ– the free and conjugated forms of the 2777 S. Crystal Dr., Arlington, VA. The OPP–2008–0125 in the subject line on resolved isomer of fluazifop, (R)-2-[4- Docket Facility is open from 8:30 a.m. the first page of your submission. All [[5-(trifluoromethyl)-2- to 4 p.m., Monday through Friday, objections and requests for a hearing pyridinyl]oxy]phenoxy]propanoic acid, excluding legal holidays. The Docket must be in writing, and must be calculated as the stoichiometric Facility telephone number is (703) 305– received by the Hearing Clerk on or equivalent of fluazifop, in or on the 5805. before April 4, 2011. Addresses for mail commodity. FOR FURTHER INFORMATION CONTACT: and hand delivery of objections and * * * * * Laura Nollen, Registration Division hearing requests are provided in 40 CFR [FR Doc. 2011–1779 Filed 2–1–11; 8:45 am] (7505P), Office of Pesticide Programs, 178.25(b). BILLING CODE 6560–50–P Environmental Protection Agency, 1200 In addition to filing an objection or Pennsylvania Ave., NW., Washington, hearing request with the Hearing Clerk DC 20460–0001; telephone number: as described in 40 CFR part 178, please ENVIRONMENTAL PROTECTION (703) 305–7390; e-mail address: submit a copy of the filing that does not AGENCY [email protected]. contain any CBI for inclusion in the public docket. Information not marked SUPPLEMENTARY INFORMATION: 40 CFR Part 180 confidential pursuant to 40 CFR part 2 [EPA–HQ–OPP–2008–0125; FRL–8860–1] I. General Information may be disclosed publicly by EPA without prior notice. Submit a copy of A. Does this action apply to me? Sulfentrazone; Pesticide Tolerances your non-CBI objection or hearing You may be potentially affected by request, identified by docket ID number AGENCY: Environmental Protection this action if you are an agricultural EPA–HQ–OPP–2008–0125, by one of Agency (EPA). producer, food manufacturer, or the following methods: ACTION: Final rule. pesticide manufacturer. Potentially • Federal eRulemaking Portal: http:// affected entities may include, but are www.regulations.gov. Follow the on-line SUMMARY: This regulation establishes not limited to those engaged in the instructions for submitting comments. tolerances for residues of sulfentrazone following activities: • Mail: Office of Pesticide Programs in or on multiple commodities. • Crop production (NAICS code 111). (OPP) Regulatory Public Docket (7502P), Additionally, this regulation deletes • Animal production (NAICS code Environmental Protection Agency, 1200 existing tolerances on commodities 112). Pennsylvania Ave., NW., Washington, superseded by the establishment of crop • Food manufacturing (NAICS code DC 20460–0001. subgroups. This regulation also deletes 311). • Delivery: OPP Regulatory Public a time-limited tolerance on bean, • Pesticide manufacturing (NAICS Docket (7502P), Environmental succulent seed without pod (lima bean code 32532). Protection Agency, Rm. S–4400, One and cowpea), as the tolerance expired This listing is not intended to be Potomac Yard (South Bldg.), 2777 S. on December 31, 2007. Interregional exhaustive, but rather to provide a guide Crystal Dr., Arlington, VA. Deliveries Research Project Number 4 (IR–4) for readers regarding entities likely to be are only accepted during the Docket requested these tolerances under the affected by this action. Other types of Facility’s normal hours of operation Federal Food, Drug, and Cosmetic Act entities not listed in this unit could also (8:30 a.m. to 4 p.m., Monday through (FFDCA). be affected. The North American Friday, excluding legal holidays).

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Special arrangements should be made determines that the tolerance is ‘‘safe.’’ reduced/delayed skeletal ossifications for deliveries of boxed information. The Section 408(b)(2)(A)(ii) of FFDCA were noted at doses that were not Docket Facility telephone number is defines ‘‘safe’’ to mean that ‘‘there is a maternally toxic. In rabbits, (703) 305–5805. reasonable certainty that no harm will developmental effects such as decreased result from aggregate exposure to the pup viability were observed at a II. Summary of Petitioned-For pesticide chemical residue, including maternally toxic dose (clinical signs, Tolerances all anticipated dietary exposures and all abortions and decreased body weight In the Federal Register of March 12, other exposures for which there is gains). In the 2-generation reproduction 2008 (73 FR 13225) (FRL–3854–6), EPA reliable information.’’ This includes study in rats, offspring effects such as issued a notice pursuant to section exposure through drinking water and in decreased body weights and decreased 408(d)(3) of FFDCA, 21 U.S.C. residential settings, but does not include litter survival were observed at a 346a(d)(3), announcing the filing of a occupational exposure. Section maternally toxic dose (slightly pesticide petition (PP 7E7308) by IR–4, 408(b)(2)(C) of FFDCA requires EPA to decreased body weight gain). 500 College Road East, Suite 201 W., give special consideration to exposure In the acute neurotoxicity study, an Princeton, NJ 08540. The petition of infants and children to the pesticide increased incidence of clinical signs requested that 40 CFR 180.498 be chemical residue in establishing a (staggered gait, splayed hind limbs, and amended by establishing tolerances for tolerance and to ‘‘ensure that there is a abdominal gripping), changes in residues of the combined free and reasonable certainty that no harm will functional observation battery (FOB) conjugated residues of the herbicide result to infants and children from parameters, and decreased motor sulfentrazone, [N-[2,4-dichloro-5-[4- aggregate exposure to the pesticide activity were observed; however, (difluoromethyl)-4,5-dihydro-3-methyl- chemical residue. * * *’’ complete recovery was observed within 5-oxo-1H-1,2,4-triazol-1- Consistent with section 408(b)(2)(D) 14 days and there was no evidence of yl]phenyl]methanesulfonamide] and its of FFDCA, and the factors specified in neuropathology. In the subchronic metabolites HMS [N-(2,4-dichloro-5-(4- section 408(b)(2)(D) of FFDCA, EPA has neurotoxicity study, clinical signs of (difluoromethyl)-4,5-dihydro-3- reviewed the available scientific data toxicity, increased motor activity, and/ hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- and other relevant information in or decreased body weights, body weight yl)phenyl)methanesulfonamide] and support of this action. EPA has gain, and food consumption were DMS [(N-2,4-dichloro-5-[4- sufficient data to assess the hazards of observed. There was no evidence of (difluoromethyl)-4,5-dihydro-5-oxo-1H- and to make a determination on neuropathology in either study. In a 1,2,4-triazol-1- aggregate exposure for sulfentrazone published, non-guideline yl)phenyl)methanesulfonamide] in or on including exposure resulting from the developmental toxicity study in the rat food commodities Brassica, head and tolerances established by this action. (de Castro, et al., 2007), several dose- stem, subgroup 5A at 0.20 parts per EPA’s assessment of exposures and risks dependent effects (delayed ear opening, million (ppm); Brassica, leafy greens, associated with sulfentrazone follows. decreased grip response and rearing subgroup 5B at 0.35 ppm; melon, frequency, and increased surface A. Toxicological Profile subgroup 9A at 0.10 ppm; vegetable, righting reflex reaction time) were fruiting, group 8 at 0.05 ppm; okra at EPA has evaluated the available reported in pups whose mothers were 0.05 ppm; pea, succulent at 0.05 ppm; toxicity data and considered its validity, treated with sulfentrazone. However, flax at 0.05 ppm; strawberry at 0.05 completeness, and reliability as well as this study had several shortcomings that ppm; and vegetable, tuberous and corn, the relationship of the results of the limit its use for regulatory purposes. subgroup 1C at 0.15 ppm. That notice studies to human risk. EPA has also Carcinogenicity studies in rats and referenced a summary of the petition considered available information mice showed no evidence of increased prepared on behalf of IR–4 by FMC concerning the variability of the incidence of tumor formation due to Corporation, the registrant, which is sensitivities of major identifiable treatment with sulfentrazone. Therefore, available in the docket, http:// subgroups of consumers, including the EPA classified sulfentrazone as ‘‘not www.regulations.gov. Comments were infants and children. likely to be carcinogenic to humans.’’ received on the notice of filing. EPA’s Sulfentrazone has low acute toxicity The available mutagenicity studies response to these comments is via the oral, dermal, and inhalation indicate that sulfentrazone is weakly discussed in Unit IV.C. routes of exposure. It is a mild eye clastogenic in the in vitro mouse Based upon review of the data irritant, but not a dermal irritant or lymphoma assay in the absence of S9 supporting the petition, EPA has revised sensitizer. Subchronic and chronic activation; however, the response was the proposed tolerance levels for several toxicity studies in rats, mice and dogs not evident in the presence of S9 commodities. Additionally, the EPA has identified the hematopoietic system as activation. Sulfentrazone is neither assessed several additional fruiting the target of sulfentrazone. mutagenic in bacterial cells, nor vegetable commodities in order to Protoporphyrinogen oxidase inhibition clastogenic in male or female mice in establish the revised and expanded in the mammalian species may result in vivo. fruiting vegetable group 8–10. EPA has disruption of heme synthesis. In these Specific information on the studies also revised the tolerance expression for studies, disruption of heme synthesis received and the nature of the adverse all established commodities to be was observed at about the same dose effects caused by sulfentrazone as well consistent with current Agency policy. levels across species except in the case as the no-observed-adverse-effect-level The reasons for these changes are of mice, where the effects were seen at (NOAEL) and the lowest-observed- explained in Unit IV.D. a slightly higher dose. The adverse-effect-level (LOAEL) from the hematotoxicity occurred around the toxicity studies can be found at http:// III. Aggregate Risk Assessment and same dose level for short- through long- www.regulations.gov in document: Determination of Safety term exposure without increasing in ‘‘Sulfentrazone; REVISED Section 3 Section 408(b)(2)(A)(i) of FFDCA severity. Registration Request to Add New Uses allows EPA to establish a tolerance (the In the oral and dermal rat on: Brassica, Head and Stem, Subgroup legal limit for a pesticide chemical developmental toxicity studies, 5A; Brassica, Leafy Greens, Subgroup residue in or on a food) only if EPA decreased fetal body weights and 5B; Melon, Subgroup 9A; Fruiting

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Vegetable, Group 8 and Okra; Pea, including the acute dietary endpoints unlikely due to a single dose event and Succulent; Flax; Strawberry; and for females 13–49 years old, the chronic are more appropriate for a repeated- Tuberous and Corm Vegetable, dietary endpoint, and the short- and exposure scenario. Furthermore, EPA Subgroup 1C. Human-Health Risk intermediate-term inhalation endpoint has not traditionally considered delays Assessment.’’ pp. 51–56 in docket ID have been revised since the last risk in ossification (and related fetal body number EPA–HQ–OPP–2008–0125. assessment based on a re-evaluation of weight deficits) to be single dose effects. B. Toxicological Points of Departure/ the toxicology database. The updated The chronic dietary endpoint is based Levels of Concern endpoints are protective of on developmental toxicity (decreased sulfentrazone’s developmental toxicity, fetal weights and delay in skeletal Once a pesticide’s toxicological which was the critical effect in the ossification) that was observed in the profile is determined, EPA identifies database and observed via both the oral oral developmental toxicity study in the toxicological points of departure (POD) and dermal routes of exposure. rat. This study provides the lowest and levels of concern (LOC) to use in The acute dietary endpoint is based NOAEL in the database, and the effects evaluating the risk posed by human are similar to those observed in exposure to the pesticide. For hazards on increased gestation duration, reduced prenatal viability (fetal and offspring (decreased body weight) at a that have a threshold below which there slightly higher dose in the 2-generation is no appreciable risk, the toxicological litter), reduced litter size, increased number of stillborn pups, reduced reproduction study in rats. In addition, POD is used as the basis for derivation choice of the developmental toxicity of reference values for risk assessment. postnatal survival (pups and litter), and study in the rat protects against PODs are developed based on a careful pup body weight deficits throughout exposure of women throughout their analysis of the doses in each lactation in both generations of offspring entire lifespan, which includes their toxicological study to determine the observed in a 2-generation reproductive childbearing years. dose at the NOAEL and the lowest dose toxicity study in rats. The at which adverse effects of concern are developmental effects were reported in The short- and intermediate-term identified (the LOAEL). Uncertainty/ the presence of mild maternal toxicity inhalation endpoints are based on safety factors are used in conjunction (slightly decreased body-weight gain, developmental toxicity (decreased fetal with the POD to calculate a safe particularly in F1 females). It has been weights, delay in skeletal ossification) exposure level—generally referred to as EPA’s practice to consider various forms that was observed in the oral a population-adjusted dose (PAD) (a = of developmental toxicity such as developmental toxicity study in the rat. acute, c = chronic) or a reference dose reduced prenatal viability, reduced litter An oral study was chosen for this (RfD)—and a safe margin of exposure size, and increased number of stillborn exposure scenario in the absence of an (MOE). For non-threshold risks, the pups as single-dose effects and, inhalation toxicity study. Assuming Agency assumes that any amount of therefore, relevant for the acute dietary 100% absorption via the inhalation exposure will lead to some degree of (females aged 13–49) exposure scenario, route, the oral developmental toxicity risk. Thus, the Agency estimates risk in in order to protect against potential study protects pregnant women who terms of the probability of an occurrence exposure of pregnant females. It should might be exposed via inhalation against of the adverse effect expected in a be noted that the fetal body weight the critical effect observed in the lifetime. For more information on the deficits and retardation in skeletal sulfentrazone database, developmental general principles EPA uses in risk development (including decreased toxicity. characterization and a complete numbers of caudal vertebral and The endpoints for the other exposure description of the risk assessment metacarpal ossification sites) reported in scenarios remain the same. A summary process, see http://www.epa.gov/ the oral rat prenatal developmental of the toxicological endpoints for pesticides/factsheets/riskassess.htm. toxicity study were also evaluated for sulfentrazone used for human risk The doses and toxicological endpoints this acute dietary endpoint. However, it assessment is shown in Table 1 of this selected for several exposure scenarios was concluded that such effects are unit.

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE 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 ...... NOAEL = 14 milli- Acute RfD = 0.14 2-Generation Reproductive Toxicity Study—Rat, Offspring Toxicity LOAEL= (Females 13–49 grams/kilogram/ mg/kg/day. 33 (M) and 40 (F) mg/kg/day based on reduced prenatal viability (fetal & lit- years of age). day (mg/kg/day). aPAD = 0.14 mg/ ter), reduced litter size, increased number of stillborn pups, reduced pup UFA = 10x ...... kg/day. and litter postnatal survival and decreased pup body weights throughout UFH = 10x ...... lactation. FQPA SF = 1x ...... Acute dietary ...... NOAEL = 250 mg/ Acute RfD = 2.5 Acute-Neurotoxicity Study—Rat, LOAEL = 750 mg/kg/day based on increased (General population kg/day. mg/kg/day. incidence of clinical signs and FOB parameters and decreased motor activ- including infants UFA = 10x ...... aPAD = 2.5 mg/kg/ ity. and children). UFH = 10x ...... day. FQPA SF = 1x ...... Chronic dietary (All NOAEL= 10 mg/kg/ Chronic RfD = 0.1 Prenatal Developmental Toxicity—Rat, Developmental LOAEL = 25 mg/kg/ populations). day. mg/kg/day. day, based upon decreased mean fetal weights, and retardation in skeletal UFA = 10x ...... cPAD = 0.1 mg/kg/ development evidenced by an increased number of litters with any variation UFH = 10x ...... day. and by decreased number of caudal vertebral and metacarpal ossification FQPA SF = 1x ...... sites.

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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFENTRAZONE FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued

Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment

Incidental oral short- NOAEL= 14 mg/kg/ LOC for MOE = 2-Generation Reproduction Study—Rat, LOAEL = 33 mg/kg/day based on de- term (1 to 30 day. 100. creased pup body weights during lactation and reduced postnatal survival days) and inter- UFA = 10x ...... in both generations. mediate-term (1 to UFH = 10x ...... 6 months). FQPA SF = 1x ...... Dermal short-term (1 Dermal (or oral) LOC for MOE = Dermal Developmental Study—Rat, LOAEL = 250 mg/kg/day based on de- to 30 days) and study NOAEL = 100. creased fetal body weight; increased incidences of fetal variations: hypo- intermediate-term. 100 mg/kg/day. plastic or wavy ribs, incompletely ossified lumbar vertebral arches, and in- (1 to 6 months) ...... UFA = 10x ...... completely ossified ischia or pubes; and reduced number of thoracic UFH = 10x ...... vertebral and rib ossification sites. FQPA SF = 1x ...... Inhalation short-term Inhalation (or oral) LOC for MOE = Prenatal Developmental Toxicity—Rat, Developmental LOAEL = 25 mg/kg/ (1 to 30 days). study NOAEL= 100. day, based upon decreased mean fetal weights, and retardation in skeletal 10 mg/kg/day development evidenced by an increased number of litters with any variation (inhalation ab- and by decreased number of caudal vertebral and metacarpal ossification sorption rate = sites. 100%). UFA = 10x ...... UFH = 10x ...... FQPA SF = 1x ......

Cancer (Oral, der- Sulfentrazone is classified as ‘‘not likely to be carcinogenic to humans.’’ mal, inhalation).

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor.

C. Exposure Assessment ii. Chronic exposure. In conducting Sulfentrazone and 3-carboxylic acid the chronic dietary exposure assessment sulfentrazone are the residues of 1. Dietary exposure from food and EPA used the food consumption data concern in drinking water. Therefore, feed uses. In evaluating dietary from the USDA 1994–1996 and 1998 the First Index Reservoir Screening Tool exposure to sulfentrazone, EPA CSFII. As to residue levels in food, EPA (FIRST) model was used to estimate considered exposure under the used tolerance-level residues, DEEMTM concentrations of sulfentrazone and 3- petitioned-for tolerances as well as all (ver. 7.81) default processing factors, carboxylic acid sulfentrazone in surface existing sulfentrazone tolerances in 40 and assumed 100 PCT for all water, and the Screening Concentration CFR 180.498. EPA assessed dietary commodities. in Ground Water (SCI–GROW) model exposures from sulfentrazone in food as iii. Cancer. Based on the data was utilized to estimate concentrations follows: summarized in Unit III.A., EPA has in ground water. The estimated drinking i. Acute exposure. Quantitative acute concluded that sulfentrazone does not water concentrations (EDWCs) of dietary exposure and risk assessments pose a cancer risk to humans. Therefore, sulfentrazone and 3-carbyoxylic acid are performed for a food-use pesticide, a dietary exposure assessment for the sulfentrazone for acute exposures are if a toxicological study has indicated the purpose of assessing cancer risk is estimated to be 35.8 parts per billion possibility of an effect of concern unnecessary. (ppb) for surface water and 26.0 ppb for occurring as a result of a 1-day or single iv. Anticipated residue and PCT ground water. For chronic exposures for exposure. Such effects were identified information. EPA did not use non-cancer assessments, EDWCs are for sulfentrazone. EPA performed anticipated residue and/or PCT estimated to be 7.8 ppb for surface water separate acute risk assessments for information in the dietary assessment and 26.0 ppb for ground water. females 13–49 years old and for the for sulfentrazone. Tolerance level Modeled estimates of drinking water general population, including infants residues and/or 100 PCT were assumed concentrations were directly entered and children, based on different for all food commodities. into the dietary exposure model. For endpoints and aPADs. In estimating 2. Dietary exposure from drinking acute dietary risk assessment, the water acute dietary exposure, EPA used food water. The Agency used screening level concentration value of 35.8 ppb was consumption information from the water exposure models in the dietary used to assess the contribution to United States Department of Agriculture exposure analysis and risk assessment drinking water. For chronic dietary risk (USDA) 1994–1996 and 1998 for sulfentrazone in drinking water. assessment, the water concentration of Nationwide Continuing Surveys of Food These simulation models take into value 26.0 ppb was used to assess the Intake by Individuals (CSFII). As to account data on the physical, chemical, contribution to drinking water. residue levels in food, EPA used and fate/transport characteristics of 3. From non-dietary exposure. The tolerance-level residues, Dietary sulfentrazone. Further information term ‘‘residential exposure’’ is used in Exposure Evaluation Model (DEEM)TM regarding EPA drinking water models this document to refer to non- (ver. 7.81) default processing factors, used in pesticide exposure assessment occupational, non-dietary exposure and assumed 100 percent crop treated can be found at http://www.epa.gov/ (e.g., for lawn and garden pest control, (PCT) for all commodities. oppefed1/models/water/index.htm. indoor pest control, termiticides, and

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flea and tick control on pets). regarding EPA’s efforts to determine the immune system; the overall weight Sulfentrazone is currently registered for which chemicals have a common of evidence is consistent with this the following use that could result in mechanism of toxicity and to evaluate chemical being a PPO inhibitor resulting residential exposures: residential home the cumulative effects of such in disruption of heme biosynthesis and lawns/turf and recreational turf, such as chemicals, see EPA’s Web site at subsequent effects on red blood cell golf courses (application by professional http://www.epa.gov/pesticides/ dysfunction (e.g., anemia). Unlike white applicators only). EPA assessed cumulative. blood cells (leukocytes) which are cells residential exposure using the following D. Safety Factor for Infants and of the immune system, red blood cells assumptions: Adults were assessed for Children function to deliver oxygen to body potential short-term dermal and tissues and are not involved in eliciting inhalation handler exposure from 1. In general. Section 408(b)(2)(C) of an immune response. Furthermore, applying sulfentrazone to residential FFDCA provides that EPA shall apply there is no indication in the × turf/home lawns and for short-term an additional tenfold (10 ) margin of sulfentrazone database of any effect on postapplication dermal exposure from safety for infants and children in the leukocyte counts (an indicator of contact with treated residential and case of threshold effects to account for immune function). Thus, the overall recreational turf (home lawns and golf prenatal and postnatal toxicity and the weight of evidence indicates that this courses). Youths, ages 10–12 years old, completeness of the database on toxicity chemical does not directly target the were selected as a representative and exposure unless EPA determines immune system. Sulfentrazone also population to assess postapplication based on reliable data that a different does not belong to a class of chemicals dermal exposure from contact with margin of safety will be safe for infants (e.g., the organotins, heavy metals, or treated residential and recreational turf and children. This additional margin of halogenated aromatic hydrocarbons) (home lawns and golf courses). safety is commonly referred to as the that would be expected to be Children, ages 3–6 years old, were FQPA Safety Factor (SF). In applying immunotoxic. Based on the above selected as a representative population this provision, EPA either retains the × considerations, EPA does not believe to assess for postapplication dermal and default value of 10 , or uses a different that conducting a functional incidental oral (hand-to-mouth, object- additional safety factor when reliable immunotoxicity study will result in a to-mouth, soil ingestion and episodic data available to EPA support the choice lower point of departure than that ingestion of granules) exposure to of a different factor. currently used for overall risk 2. Prenatal and postnatal sensitivity. residential turf/home lawns. As short- assessment. Therefore, an additional There is evidence of increased and intermediate-term points of database UF to account for potential quantitative susceptibility following in departure are the same, the short-term immunotoxicity does not need to be utero exposure in the oral and dermal assessment is considered protective of applied. intermediate-term exposures. For rat developmental toxicity studies. ii. The toxicity database for children, however, while all three Developmental effects, including sulfentrazone does not trigger the need incidental oral exposures were decreased fetal body weights and for a developmental neurotoxicity aggregated for short-term exposures, the reduced/delayed skeletal ossifications intermediate-term postapplication were observed at doses that were not (DNT) study. There are no indications in exposure scenario included only the soil maternally toxic. In the 2-generation any of the studies available that the ingestion incidental oral pathway, as reproduction study in rats, offspring nervous system is a target for this is the only pathway assumed to effects such as decreased body weights sulfentrazone. The FOB findings were potentially result in intermediate-term and decreased litter survival were very non-specific signs of toxicity exposures. Chronic exposures are not observed at a slightly maternally toxic (perianal staining, colored tears) and expected and were not assessed. dose (slightly decreased body weight motor activity changes only occurred at Further information regarding EPA gain), indicating possible slightly higher doses following acute exposure standard assumptions and generic increased qualitative susceptibility. with rapid reversibility, also indicating inputs for residential exposures may be Additionally, several dose-dependent general toxicity rather than specific found at http://www.epa.gov/pesticides/ effects were observed in rat pups whose neurotoxicity. The lack of trac/science/trac6a05.pdf. mothers were treated with sulfentrazone neuropathological findings further 4. Cumulative effects from substances in a published non-guideline rat supports the non-specific nature of the with a common mechanism of toxicity. developmental toxicity study. signs observed. In addition, there is a Section 408(b)(2)(D)(v) of FFDCA 3. Conclusion. EPA has determined literature DNT study available for requires that, when considering whether that reliable data show the safety of sulfentrazone. The only reliable effects to establish, modify, or revoke a infants and children would be seen in this study involved effects on tolerance, the Agency consider adequately protected if the FQPA SF physical and reflex development, which ‘‘available information’’ concerning the were reduced to 1X. That decision is are known to be affected by body cumulative effects of a particular based on the following findings: weight. Therefore, these effects are pesticide’s residues and ‘‘other i. The toxicity database for likely secondary to the effects substances that have a common sulfentrazone is complete except for (including body weight deficits) mechanism of toxicity.’’ immunotoxicity testing. Recent changes reported in the 2-generation EPA has not found sulfentrazone to to 40 CFR part 158 require reproductive toxicity study. EPA share a common mechanism of toxicity immunotoxicity testing (OPPTS Test employed an independent statistical with any other substances, and Guideline 870.7800) for pesticide method to evaluate the literature DNT in sulfentrazone does not appear to registration. However, the existing data an effort to determine if these effects produce a toxic metabolite produced by are sufficient for endpoint selection for were consistent with effects observed in other substances. For the purposes of exposure/risk assessment scenarios, and other guideline studies at these same this tolerance action, therefore, EPA has for evaluation of the requirements under dose levels. The results of that analysis assumed that sulfentrazone does not the FQPA. The toxicology database for indicate that the results of the literature have a common mechanism of toxicity sulfentrazone does not show any DNT study are consistent with what was with other substances. For information evidence of treatment-related effects on observed in the rat 2-generation

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reproduction study and that the studies applicable aPAD chosen for that Meade, MD 20755–5350; telephone used for risk assessment (NOAEL of 10 population subgroup. number: (410) 305–2905; e-mail mg/kg/day from the developmental 2. Chronic risk. Using the exposure address: [email protected]. assumptions described in this unit for toxicity study in rat and the NOAEL of B. International Residue Limits 14 mg/kg/day from the 2–generation chronic exposure, EPA has concluded reproduction study), are protective of that chronic exposure to sulfentrazone In making its tolerance decisions, EPA the observations made at ≥25 mg/kg/day from food and water will utilize 3.6% of seeks to harmonize U.S. tolerances with in the literature study for which a the cPAD for children 1–2 years old, the international standards whenever NOAEL was not attained. Based on the population group receiving the greatest possible, consistent with U.S. food weight of evidence, there is no exposure. Based on the explanation in safety standards and agricultural uncertainty related to developmental Unit III.C.3., regarding residential use practices. EPA considers the neurotoxicity. patterns, chronic residential exposure to international maximum residue limits iii. There is evidence of increased residues of sulfentrazone is not (MRLs) established by the Codex quantitative susceptibility following in expected. Alimentarius Commission (Codex), as utero exposure in the oral and dermal 3. Short- and intermediate-term risk. required by FFDCA section 408(b)(4). developmental toxicity studies in rats Short- and intermediate-term aggregate The Codex Alimentarius is a joint U.N. and possible evidence of slightly exposure takes into account short- and Food and Agriculture Organization/ increased qualitative susceptibility of intermediate-term residential exposure World Health Organization food offspring in the 2-generation rat plus chronic exposure to food and water standards program, and it is recognized reproduction study. However, concern (considered to be a background as an international food safety is low because clear NOAELs have been exposure level). Sulfentrazone is standards-setting organization in trade identified for the effects noted in these currently registered for uses that could agreements to which the United States studies and both of the developmental result in short- and intermediate-term is a party. EPA may establish a tolerance toxicity studies have been chosen for residential exposure, and the Agency that is different from a Codex MRL; endpoint selection, thereby protecting has determined that it is appropriate to however, FFDCA section 408(b)(4) the relevant human subpopulations aggregate chronic exposure through food requires that EPA explain the reasons from the noted effects. and water with short- and intermediate- for departing from the Codex level. There are no Codex, Canadian, or iv. There are no residual uncertainties term residential exposures to Mexican MRLs established for residues identified in the exposure databases. sulfentrazone. of sulfentrazone in or on the subject The dietary food exposure assessments Using the exposure assumptions commodities. were performed based on 100 PCT and described in this unit for short- and tolerance-level residues. EPA made intermediate-term exposures, EPA has C. Response to Comments concluded the combined short- and conservative (protective) assumptions in EPA received one comment to the the ground and surface water modeling intermediate-term food, water, and residential exposures result in aggregate Notice of Filing that had an objection to used to assess exposure to sulfentrazone ‘‘the manufacture or sale’’ of in drinking water. EPA used similarly MOEs of 310 for the general U.S. population; 450 for children 1–2 years sulfentrazone, citing the cruelty of conservative assumptions to assess animal testing as the main source of postapplication exposure of children as old for short-term exposures; and 590 for children 1–2 years old for opposition. The Agency has received well as incidental oral exposure of these same or similar comments from toddlers. These assessments will not intermediate-term exposures. Because EPA’s level of concern for sulfentrazone this commenter on numerous previous underestimate the exposure and risks occasions. Please refer to the Federal posed by sulfentrazone. is a MOE of 100 or below, these MOEs are not of concern. Register of 70 FR 1349 (January 7, 2005) E. Aggregate Risks and Determination of 4. Aggregate cancer risk for U.S. and 70 FR 37683 (June 30, 2005) for the Safety population. Based on the lack of Agency’s previous responses to these and other similar comments. EPA determines whether acute and evidence of carcinogenicity in two chronic dietary pesticide exposures are adequate rodent carcinogenicity studies, D. Revisions to Petitioned-For safe by comparing aggregate exposure sulfentrazone is not expected to pose a Tolerances estimates to the aPAD and cPAD. For cancer risk to humans. Based upon review of the data linear cancer risks, EPA calculates the 5. Determination of safety. Based on supporting the petition, EPA revised the lifetime probability of acquiring cancer these risk assessments, EPA concludes proposed tolerances for the following given the estimated aggregate exposure. that there is a reasonable certainty that commodities: Brassica, leafy greens, Short-, intermediate-, and chronic-term no harm will result to the general subgroup 5B from 0.35 ppm to 0.40 risks are evaluated by comparing the population, or to infants and children ppm; melon, subgroup 9A from 0.10 estimated aggregate food, water, and from aggregate exposure to ppm to 0.15 ppm; vegetable, fruiting, residential exposure to the appropriate sulfentrazone residues. group 8 from 0.05 ppm to 0.15 ppm; PODs to ensure that an adequate MOE IV. Other Considerations okra from 0.05 ppm to 0.15 ppm; pea, exists. succulent from 0.05 ppm to 0.15 ppm; 1. Acute risk. Using the exposure A. Analytical Enforcement Methodology flax from 0.05 ppm to 0.15 ppm; and assumptions discussed in this unit for Adequate enforcement methodology strawberry from 0.05 ppm to 0.15 ppm. acute exposure, the acute dietary (gas chromatography (GC)) is available EPA revised the tolerance levels based exposure from food and water to to enforce the tolerance expression. The on analysis of the residue field trial data sulfentrazone will occupy <1% of the method has been forwarded for using the Agency’s Tolerance aPAD for the general population, inclusion in the Pesticides Analytical Spreadsheet in accordance with the including infants and children. For Manual, Volume II. The method may be Agency’s Guidance for Setting Pesticide females 13–49 years old, the acute requested from: Chief, Analytical Tolerances Based on Field Trial Data. dietary exposure to sulfentrazone from Chemistry Branch, Environmental Additionally, EPA was petitioned for food and water will occupy 2.3% of the Science Center, 701 Mapes Rd., Ft. tolerances on fruiting vegetable group 8

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and a separate tolerance on okra. In the VI. Statutory and Executive Order Unfunded Mandates Reform Act of 1995 Federal Register of December 8, 2010 Reviews (UMRA) (Public Law 104–4). (75 FR 76284) (FRL–8853–8), EPA This final rule establishes tolerances This action does not involve any issued a final rule that revised the crop under section 408(d) of FFDCA in technical standards that would require grouping regulations. As part of this response to a petition submitted to the Agency consideration of voluntary action, EPA expanded and revised the Agency. The Office of Management and consensus standards pursuant to section existing fruiting vegetable crop group 8. Budget (OMB) has exempted these types 12(d) of the National Technology Changes to crop group 8 included of actions from review under Executive Transfer and Advancement Act of 1995 adding okra, cocona, African eggplant, Order 12866, entitled Regulatory (NTTAA), Public Law 104–113, section pea eggplant, scarlet eggplant, goji berry, Planning and Review (58 FR 51735, 12(d) (15 U.S.C. 272 note). garden huckleberry, martynia, October 4, 1993). Because this final rule VII. Congressional Review Act naranjilla, roselle, sunberry, bush has been exempted from review under The Congressional Review Act, 5 tomato, currant tomato, and tree tomato; Executive Order 12866, this final rule is creating subgroups; revising the U.S.C. 801 et seq., generally provides not subject to Executive Order 13211, representative commodities; and that before a rule may take effect, the entitled Actions Concerning Regulations naming the new crop group fruiting agency promulgating the rule must That Significantly Affect Energy Supply, vegetable group 8–10. EPA indicated in submit a rule report to each House of Distribution, or Use (66 FR 28355, May the December 8, 2010 final rule as well the Congress and to the Comptroller 22, 2001) or Executive Order 13045, as the earlier January 6, 2010 proposed General of the United States. EPA will entitled Protection of Children from rule (75 FR 807) (FRL–8801–2) that, for submit a report containing this rule and Environmental Health Risks and Safety existing petitions for which a Notice of other required information to the U.S. Risks (62 FR 19885, April 23, 1997). Filing had been published, the Agency Senate, the U.S. House of This final rule does not contain any would attempt to conform these Representatives, and the Comptroller information collections subject to OMB petitions to the rule. Therefore, General of the United States prior to approval under the Paperwork consistent with this rule, EPA has publication of this final rule in the Reduction Act (PRA), 44 U.S.C. 3501 et assessed and is establishing a tolerance Federal Register. This final rule is not seq., nor does it require any special on fruiting vegetable group 8–10. a ‘‘major rule’’ as defined by 5 U.S.C. considerations under Executive Order Finally, the EPA has revised the 804(2). tolerance expression to clarify (1) that, 12898, entitled Federal Actions to as provided in FFDCA section 408(a)(3), Address Environmental Justice in List of Subjects in 40 CFR Part 180 the tolerance covers metabolites and Minority Populations and Low-Income Environmental protection, degradates of sulfentrazone not Populations (59 FR 7629, February 16, Administrative practice and procedure, specifically mentioned; and (2) that 1994). Agricultural commodities, Pesticides compliance with the specified tolerance Since tolerances and exemptions that and pests, Reporting and recordkeeping levels is to be determined by measuring are established on the basis of a petition requirements. under section 408(d) of FFDCA, such as only the specific compounds mentioned Dated: January 14, 2011. in the tolerance expression. the tolerance in this final rule, do not require the issuance of a proposed rule, Daniel J. Rosenblatt, V. Conclusion the requirements of the Regulatory Acting Director, Registration Division, Office Therefore, tolerances are established Flexibility Act (RFA) (5 U.S.C. 601 et of Pesticide Programs. for residues of the combined residues of seq.) do not apply. Therefore, 40 CFR chapter I is free and conjugated forms of This final rule directly regulates amended as follows: sulfentrazone (N-[2,4-dichloro-5-[4- growers, food processors, food handlers, (difluoromethyl)-4,5-dihydro-3-methyl- and food retailers, not States or tribes, PART 180—[AMENDED] 5-oxo-1H-1,2,4-triazol-1- nor does this action alter the ■ 1. The authority citation for part 180 yl]phenyl]methanesulfonamide) and its relationships or distribution of power metabolites HMS (N-(2,4-dichloro-5-(4- and responsibilities established by continues to read as follows: (difluoromethyl)-4,5-dihydro-3- Congress in the preemption provisions Authority: 21 U.S.C. 321(q), 346a and 371. of section 408(n)(4) of FFDCA. As such, hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- ■ 2. Section 180.498 is amended as the Agency has determined that this yl)phenyl)methanesulfonamide) and follows: action will not have a substantial direct DMS (N-(2,4-dichloro-5-(4- ■ i. Revise the introductory text of effect on States or tribal governments, (difluoromethyl)-4,5-dihydro-5-oxo-1H- paragraph (a)(1); 1,2,4-triazol-1- on the relationship between the national ■ ii. Revise the introductory text of yl)phenyl)methanesulfonamide, in or on government and the States or tribal paragraph (a)(2), remove the entries for Brassica, head and stem, subgroup 5A at governments, or on the distribution of ‘‘Cabbage’’ and ‘‘Potato’’ and add 0.20 ppm; Brassica, leafy greens, power and responsibilities among the commodities to the table; subgroup 5B at 0.40 ppm; melon, various levels of government or between ■ iii. Revise paragraph (b); and subgroup 9A at 0.15 ppm; vegetable, the Federal Government and Indian ■ iv. Revise the introductory text of fruiting, group 8–10 at 0.15 ppm; pea, tribes. Thus, the Agency has determined paragraph (d), to read as follows: succulent at 0.15 ppm; flax at 0.15 ppm; that Executive Order 13132, entitled strawberry at 0.15 ppm; and vegetable, Federalism (64 FR 43255, August 10, § 180.498 Sulfentrazone; tolerances for tuberous and corm, subgroup 1C at 0.15 1999) and Executive Order 13175, residues. ppm. Additionally, this regulation entitled Consultation and Coordination (a)(1) General. Tolerances are deletes existing individual tolerances in with Indian Tribal Governments (65 FR established for the combined residues of or on cabbage at 0.20 ppm and potato 67249, November 9, 2000) do not apply the free and conjugated forms of at 0.15 ppm, and further deletes the to this final rule. In addition, this final sulfentrazone, including its metabolites time-limited tolerance for bean, rule does not impose any enforceable and degradates, in or on the succulent seed without pod (lima bean duty or contain any unfunded mandate commodities in the table below. and cowpea) at 0.1 ppm. as described under Title II of the Compliance with the tolerance levels

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specified below is to be determined by DMS (N-(2,4-dichloro-5-(4- (b) Section 18 emergency exemptions. measuring only the sum of (difluoromethyl)-4,5-dihydro-5-oxo-1H- Time-limited tolerances are established sulfentrazone (N-[2,4-dichloro-5-[4- 1,2,4-triazol-1- for the combined residues of the free (difluoromethyl)-4,5-dihydro-3-methyl- yl)phenyl)methanesulfonamide, and conjugated forms of sulfentrazone, 5-oxo-1H-1,2,4-triazol-1- calculated as the stoichiometric including its metabolites and yl]phenyl]methanesulfonamide) and its equivalent of sulfentrazone in or on the degradates, in connection with use of metabolite HMS (N-(2,4-dichloro-5-(4- following commodities. the pesticide under section 18 (difluoromethyl)-4,5-dihydro-3- emergency exemptions granted by EPA. Parts per hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- Commodity Compliance with the tolerance levels yl)phenyl)methanesulfonamide, million specified below is to be determined by calculated as the stoichiometric measuring only the sum of equivalent of sulfentrazone in or on the ***** following commodities. sulfentrazone (N-[2,4-dichloro-5-[4- Brassica, head and stem, sub- (difluoromethyl)-4,5-dihydro-3-methyl- * * * * * group 5A ...... 0.20 5-oxo-1H-1,2,4-triazol-1- (2) Tolerances are established for the Brassica, leafy greens, subgroup combined residues of the free and 5B ...... 0.40 yl]phenyl]methanesulfonamide) and its conjugated forms of sulfentrazone, metabolites HMS (N-(2,4-dichloro-5-(4- including its metabolites and ***** (difluoromethyl)-4,5-dihydro-3- degradates, in or on the commodities in Flax ...... 0.15 hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- yl)phenyl)methanesulfonamide) and the table below. Compliance with the ***** tolerance levels specified below is to be Melon, subgroup 9A ...... 0.15 DMS (N-(2,4-dichloro-5-(4- determined by measuring only the sum Pea, succulent ...... 0.15 (difluoromethyl)-4,5-dihydro-5-oxo-1H- of sulfentrazone (N-[2,4-dichloro-5-[4- 1,2,4-triazol-1- (difluoromethyl)-4,5-dihydro-3-methyl- ***** yl)phenyl)methanesulfonamide, 5-oxo-1H-1,2,4-triazol-1- Strawberry ...... 0.15 calculated as the stoichiometric yl]phenyl]methanesulfonamide) and its equivalent of sulfentrazone in or on the metabolites HMS (N-(2,4-dichloro-5-(4- ***** following commodities. These (difluoromethyl)-4,5-dihydro-3- Vegetable, fruiting, group 8–10 .. 0.15 Vegetable, tuberous and corm, tolerances expire and are revoked on the hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- subgroup 1C ...... 0.15 dates specified in the following table. yl)phenyl)methanesulfonamide) and

Parts per Expiration/ Commodity million revocation date

Flax, seed ...... 0.20 12/31/13 Strawberry ...... 0.60 12/31/13

* * * * * therein as a result of the application of provided in 40 CFR part 178 (see also (d) Indirect or inadvertent residues. sulfentrazone to growing crops. Unit I.C. of the SUPPLEMENTARY Tolerances are established for * * * * * INFORMATION). inadvertent and indirect combined [FR Doc. 2011–1898 Filed 2–1–11; 8:45 am] ADDRESSES: EPA has established a residues of the free and conjugated BILLING CODE 6560–50–P docket for this action under docket forms of sulfentrazone, including its identification (ID) number EPA–HQ– metabolites and degradates, in or on the OPP–2009–0796. All documents in the ENVIRONMENTAL PROTECTION commodities in the table below. docket are listed in the docket index AGENCY Compliance with the tolerance levels available at http://www.regulations.gov. specified below is to be determined by 40 CFR Part 180 Although listed in the index, some measuring only the sum of information is not publicly available, sulfentrazone (N-[2,4-dichloro-5-[4- [EPA–HQ–OPP–2009–0796; FRL–8860–2] e.g., Confidential Business Information (difluoromethyl)-4,5-dihydro-3-methyl- (CBI) or other information whose Bispyribac-sodium; Pesticide 5-oxo-1H-1,2,4-triazol-1- disclosure is restricted by statute. Tolerances yl]phenyl]methanesulfonamide) and its Certain other material, such as metabolites HMS (N-(2,4-dichloro-5-(4- AGENCY: Environmental Protection copyrighted material, is not placed on (difluoromethyl)-4,5-dihydro-3- Agency (EPA). the Internet and will be publicly hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- ACTION: Final rule. available only in hard copy form. yl)phenyl)methanesulfonamide) and Publicly available docket materials are SUMMARY: This regulation establishes DMS (N-(2,4-dichloro-5-(4- available in the electronic docket at tolerances for residues of bispyribac- (difluoromethyl)-4,5-dihydro-5-oxo-1H- http://www.regulations.gov, or, if only sodium in or on fish, freshwater. Valent 1,2,4-triazol-1- available in hard copy, at the OPP U.S.A. Corporation requested these Regulatory Public Docket in Rm. S– yl)phenyl)methanesulfonamide, tolerances under the Federal Food, 4400, One Potomac Yard (South Bldg.), calculated as the stoichiometric Drug, and Cosmetic Act (FFDCA). 2777 S. Crystal Dr., Arlington, VA. The equivalent of sulfentrazone in or on the DATES: This regulation is effective Docket Facility is open from 8:30 a.m. following commodities when present February 2, 2011. Objections and to 4 p.m., Monday through Friday, requests for hearings must be received excluding legal holidays. The Docket on or before April 4, 2011, and must be Facility telephone number is (703) 305– filed in accordance with the instructions 5805.

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