Sethoxydim; Pesticide Tolerances, 39256-39261 [E8-15519]

Download as PDF 39256 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations 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 this final rule in the Federal Register. This final rule 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: June 24, 2008. Debra Edwards, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Commodity Potato, flakes .................. Small fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 1307F .............................. Strawberry ...................... Vegetable, cucurbit, group 9 ........................ Vegetable, fruiting, group 8 .................................. Vegetable, leafy, except Brassica, group 4 ........ Vegetable, tuberous and corm, subgroup 1C 2. Section 180.641 is added to read as follows: § 180.641 Spirotetramat; tolerances for residues. (a) General. (1) Tolerances are established for residues of the insecticide spirotetramat (cis-3-(2,5dimethlyphenyl)-8-methoxy-2-oxo-1azaspiro [4.5] dec-3-en-4-yl-ethyl carbonate) and its metabolites BYI 08330-enol (cis-3-(2,5-dimethylphenyl)4-hydroxy-8-methoxy-1-azaspiro 4.5 dec-3-en-2-one), BYI 08330-ketohydroxy (cis-3-(2,5-dimethylphenyl)-3-hydroxy8-methoxy-1-azaspiro 4.5 decane-2,4dione), BYI08330-enol-Glc (cis-3-(2,5dimethylphenyl)-8-methoxy-2-oxo-1azaspiro 4.5 dec-3-en-4-yl beta-Dglucopyranoside), and BYI 08330-monohydroxy (cis-3-(2,5-dimethylphenyl)-4hydroxy-8-methoxy-1-azaspiro 4.5 decan-2-one), calculated as spirotetramat equivalents, in or on the following raw agricultural commodities: dwashington3 on PRODPC61 with RULES Commodity Parts per million 15:16 Jul 08, 2008 0.60 Commodity Parts per million Cattle, fat ........................ Cattle, meat .................... Cattle, meat byproducts Goat, fat .......................... Goat, meat ...................... Goat, meat byproducts ... Horse, fat ........................ Horse, meat .................... Horse, meat byproducts Milk ................................. Sheep, fat ....................... Sheep, meat ................... Sheep, meat byproducts 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.02 0.01 0.02 0.02 0.02 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Resereved] (d) Indirect or inadvertant residues. [Reserved] [FR Doc. E8–15521 Filed 7–8–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 9.0 [EPA–HQ–OPP–2007–0893; FRL–8370–9] 2.5 Almond, hulls .................. Brassica, head and stem, subgroup 5A ................ Brassica, leafy, subgroup 5B ................................ Citrus, oil ......................... Fruit, citrus, group 10 ..... Fruit, pome, group 11 ..... Fruit, stone, group 12 ..... Grape, raisin ................... Hop, dried cones ............ Nut, tree, group 14 ......... Onion, bulb, subgroup 3A-07 ........................... VerDate Aug<31>2005 9.0 (2) Tolerances are also established for the combined residues of spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy2-oxo-1-azaspiro [4.5] dec-3-en-4-ylethyl carbonate) and its metabolite BYI 08330-enol (cis-3-(2,5-dimethylphenyl)4-hydroxy-8-methoxy-1-azaspiro 4.5 dec-3-en-2-one), calculated as spirotetramat equivalents, in or on the following commodities: Authority: 21 U.S.C. 321(q), 346a and 371. I Project Number 4 (IR-4) requested these tolerances under the Federal Food, 1.6 Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 9, 2008. Objections and requests for 1.3 hearings must be received on or before 0.40 September 8, 2008, and must be filed in accordance with the instructions 0.30 provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY 2.5 INFORMATION). Parts per million Sethoxydim; Pesticide Tolerances Environmental Protection 8.0 Agency (EPA). 6.0 ACTION: Final rule. 0.60 AGENCY: 0.70 4.5 3.0 10.0 0.25 SUMMARY: This regulation establishes tolerances for combined residues of sethoxydim and its metabolites containing the 2-cyclohexen-1-one moiety, in or on various oilseed 0.3 commodities. Interregional Research Jkt 214001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–0893. To access the electronic docket, go to https:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–5218; e-mail address: stanton.susan@epa.gov. ADDRESSES: 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. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). E:\FR\FM\09JYR1.SGM 09JYR1 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at https://www.gpoaccess.gov/ ecfr. dwashington3 on PRODPC61 with RULES C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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–2007–0893 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before September 8, 2008. 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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– VerDate Aug<31>2005 15:16 Jul 08, 2008 Jkt 214001 HQ–OPP–2007–0893, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Petition for Tolerance In the Federal Register of September 28, 2007 (72 FR 55204) (FRL–8147–1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E7232) by Interregional Research Project Number 4 (IR–4), 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.412 be amended by establishing tolerances for combined residues of the herbicide sethoxydim, 2-[1-(ethoxyimino)butyl]-5[2-(ethylthio)propyl]-3-hydroxy-2cyclohexen-1-one, and its metabolites containing the 2-cyclohexen-1-one moiety (calculated as the herbicide), in or on cuphea, seed at 35.0 parts per million (ppm); echium, seed at 35.0 ppm; gold of pleasure, seed at 35.0 ppm; gold of pleasure, meal at 40.0 ppm; hare’s ear mustard, seed at 35.0 ppm; lesquerella, seed at 35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; sweet rocket, seed at 35.0 ppm; crambe, seed at 35.0 ppm; and crambe, meal at 40.0 ppm. That notice referenced a summary of the petition prepared by BASF, the registrant, on behalf of IR–4, which is available to the public in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 39257 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for tolerances for combined residues of sethoxydim and its metabolites containing the 2-cyclohexen-1-one moiety on crambe, meal at 40.0 ppm; crambe, seed at 35.0 ppm; cuphea, seed at 35.0 ppm; echium, seed at 35.0 ppm; gold of pleasure, meal at 40.0 ppm; gold of pleasure, seed at 35.0 ppm; hare’s ear mustard, seed at 35.0 ppm; lesquerella, seed at 35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; and sweet rocket, seed at 35.0 ppm. EPA’s assessment of exposures and risks associated with establishing these tolerances 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 acute toxicity data indicate that sethoxydim is minimally toxic via oral, dermal and inhalation routes of exposure. It is neither irritating to the eye nor the skin. With repeated dosing, the primary target organ for this chemical is the liver. In the chronic toxicity study in dogs, there were significantly increased absolute and E:\FR\FM\09JYR1.SGM 09JYR1 39258 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations dwashington3 on PRODPC61 with RULES relative liver weights accompanied by supportive clinical chemistry and histopathology. Dose-related clinical chemistry abnormalities were observed in both sexes and included increased alkaline phosphatase and aspartate aminotransferase (ALT) and decreased albumin and cholesterol synthesis. Dose-related histopathologic lesions were found in the liver, spleen and bone marrow. A mild hepatocellular cytoplasmic alteration was found in males at all doses and in females at the mid and high doses. Adverse liver effects were also observed via the oral route in mice and via the inhalation route in rats. There was no evidence of carcinogenicity in studies in rats and mice and no evidence of mutagencity, immunotoxicity or endocrine disruption in the toxicity database for sethoxydim. In the prenatal developmental studies in rats and rabbits and reproductive toxicity study in rats, the primary effects noted in the young were fetal skeletal variations and decreases in body weight. Although effects suggestive of neurotoxicity were noted in adult and young rats in the developmental and/or reproductive toxicity studies, EPA has concluded that sethoxydim is not a neurotoxic chemical. The weight of evidence EPA considered in making this determination is discussed in more detail in Unit III.D.3.ii. Specific information on the studies received and the nature of the toxic effects caused by sethoxydim as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found in the final rule published in the Federal Register of September 29, 2003 (68 FR 55858) (FRL–7238–6)(https://www.epa.gov/EPAPEST/2003/September/Day–29/ p24562.htm). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for VerDate Aug<31>2005 15:16 Jul 08, 2008 Jkt 214001 acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). 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 greater than that 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 https://www.epa.gov/ pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for sethoxydim used for human risk assessment can be found at https://www.regulations.gov in the document Sethoxydim: Amended human health risk assessment to support uses on the Rapeseed Crop Subgroup 20A at page 10 in docket ID number EPA–HQ–OPP–2007–0893. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sethoxydim, EPA considered exposure under the petitioned-for tolerances as well as all existing sethoxydim tolerances in 40 CFR 180.412. EPA assessed dietary exposures from sethoxydim 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. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that 100 percent of all crops with existing or pending tolerances are treated with sethoxydim and contain tolerance-level residues. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 from the USDA 1994–1996 and 1998 CSFII. As to residue levels in food, EPA assumed that 100 percent of all crops with existing or pending tolerances are treated with sethoxydim and contain tolerance-level residues. iii. Cancer. Based on the results of carcinogenicity studies in rats and mice, EPA classified sethoxydim as ‘‘not likely to be carcinogenic to humans’’; therefore, an exposure assessment for evaluating cancer risk is not needed for this chemical. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for sethoxydim. Tolerance level residues and 100 PCT 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 sethoxydim in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of sethoxydim. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/oppefed1/models/ water/index.htm. Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCIGROW) models, the estimated drinking water concentrations (EDWCs) of sethoxydim for acute exposures are estimated to be 130 parts per billion (ppb) for surface water and 1.5 ppb for ground water; and for chronic exposures for non-cancer assessments are estimated to be 16 ppb for surface water and 1.5 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 130 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 16 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Sethoxydim is currently registered for the following uses that could result in residential exposures: Ornamentals and flowering plants, recreational areas, and buildings/structures (outdoor). EPA assessed residential handler and E:\FR\FM\09JYR1.SGM 09JYR1 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations dwashington3 on PRODPC61 with RULES postapplication exposures using the following assumptions: Homeowners who apply sethoxydim to ornamental gardens and turf may be exposed for short-term durations via the dermal and inhalation routes. Dermal endpoints of concern were not identified for sethoxydim; therefore, dermal exposure and risk assessments are not appropriate. Short-term inhalation exposure was assessed for residential handlers who mix, load and apply liquid sethoxydim products using low-pressure hand wands, backpack sprayers and garden hose-end sprayers. Sethoxydim can be used in areas, such as home lawns, that may be frequented by adults and children. There is potential for dermal exposure of adults and children as well as incidental oral exposure of children following application of sethoxydim to such areas. Post-application inhalation exposure of adults and children is expected to be negligible. Since there are no dermal endpoints of concern for sethoxydim, only post-application incidental oral exposure of children was assessed. EPA assessed incidental oral exposure of toddlers from hand-tomouth, object-to-mouth and incidental soil ingestion activities using Standard Operating Procedures for Residential Exposure Assessments. 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 sethoxydim to share a common mechanism of toxicity with any other substances, and sethoxydim does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sethoxydim does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// 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 VerDate Aug<31>2005 15:16 Jul 08, 2008 Jkt 214001 prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for sethoxydim includes rat and rabbit developmental toxicity studies and a 2–generation reproduction toxicity study in rats. There was no evidence of increased quantitative or qualitative susceptibility of in utero rabbit fetuses following exposure to sethoxydim in the rabbit developmental study; however, evidence of increased susceptibility was noted in the rat developmental and reproduction toxicity studies as described below: There was some evidence of qualitative susceptibility in the rat developmental study with the occurrence of more severe effects in the fetuses (delayed ossification and tail abnormalities) than in the maternal animals (transient clinical signs including: Irregular gait and decreased activity) at the same dose. The degree of concern for increased susceptibility in this study is low and there are no residual uncertainties for the following reasons: The effects in the pups were of low incidence and only observed at a high dose that is considered to be close to a limit dose. In addition, these effects were seen in the presence of clear maternal toxicity and clear NOAELs and LOAELs were established for both maternal and developmental toxicities. In the 2–generation reproduction study in rats, pups showed decreases in body weight (11 to 13%) during lactation at the high dose. At the same dose, adult female animals exhibited body weight losses (8 to 10%) that are considered too small to qualify as an adverse effect. The determination that body weight effects occurred in pups at a dose that did not result in maternal toxicity is technically an indication of quantitative susceptibility. However, the degree of concern for the body weight changes in pups is low, since the weight changes are considered minimal and the differences observed in body weight losses between the adult and young animals are marginal. Characterization of the body weight changes as an adverse effect in the pups is considered conservative (protective). PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 39259 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for sethoxydim is complete. ii. Sethoxydim is not considered to be a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Clinical signs suggestive of neurotoxicity (including irregular gait, decreased activity, excessive salivation, and anogenital staining) were observed in adult rats in the developmental toxicity study. Because the clinical signs occurred shortly after dosing, only occurred at very high treatment doses (over one half the limit dose) and were transitory, it is unlikely that the signs observed are the result of a primary systemic effect on the nervous system but, rather, are reflective of the general toxicity at a high dose. An increased incidence of fetal skeletal variations due to delayed ossification was seen in young rats in the developmental and reproductive toxicity studies. In the rat prenatal study, tail abnormalities (filamentous tail or lack of a tail) were noted. These abnormalities were observed at a very low incidence and at high treatment doses. In the 2–generation reproduction study in rats, a tail anomaly (short, thread-like tail, no anal opening, hindlimbs curved toward central midline) was found in one pup in the F2b generation (1/344 total pups; in 1/ 4 litters). Tail abnormalities are sometimes thought to relate to central nervous system (CNS) malformations; however, in this case, these tail abnormalities are not likely to be the result of a primary neural tube effect. In the rat prenatal study, there is no description of any effect on neural tubederived structures. No other effects suggestive of neurotoxicity were seen in toxicology studies conducted with sethoxydim. Furthermore, cyclohexones, the class of compounds that includes sethoxydim, are not known to cause neurotoxicity or developmental malformations of the nervous system. Based on the weight of the evidence, EPA concluded that sethoxydim is not neurotoxic. iii. There is no evidence that sethoxydim results in increased susceptibility in in utero rabbits in the prenatal developmental study. Although there is qualitative evidence of increased susceptibility in the prenatal developmental study in rats and equivocal evidence of quantitative susceptibility in the 2–generation E:\FR\FM\09JYR1.SGM 09JYR1 39260 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations dwashington3 on PRODPC61 with RULES reproduction study in rats, the degree of concern is low, and the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of sethoxydim. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed assuming 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to sethoxydim in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by sethoxydim. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to sethoxydim will occupy 17% of the aPAD for children, 1 to 2 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to sethoxydim from food and water will utilize 94% of the cPAD for children, 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of sethoxydim is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus VerDate Aug<31>2005 15:16 Jul 08, 2008 Jkt 214001 chronic exposure to food and water (considered to be a background exposure level). Sethoxydim 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 sethoxydim, except residential inhalation exposures. It is not appropriate to aggregate dietary (i.e., oral) exposures and inhalation exposures because the toxic effects identified for the oral and inhalation exposure pathways differ. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures aggregated result in an aggregate MOE of 1,300 for children 1 to 2 years old (toddlers). The aggregate MOE for children includes food, drinking water and postapplication incidental oral exposures from entering turf areas previously treated with sethoxydim. Adult residential handler MOEs, based on inhalation exposure of adults who mix, load and apply liquid sethoxydim products using low-pressure hand wands, backpack sprayers or garden hose-end sprayers, range from 1.4 x 106 to 1.6 x 106, with hose-end sprayers resulting in the lowest MOE. As noted in the previous paragraph, it is not appropriate to aggregate chronic exposure from food and water with inhalation exposures. Post-application inhalation exposure of adults and children is expected to be negligible. 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). Sethoxydim is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to sethoxydim through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk. 5. Aggregate cancer risk for U.S. population. EPA has classified sethoxydim into the category ‘‘Not Likely to be Carcinogenic to Humans.’’ Sethoxydim is not expected to pose a cancer risk. 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 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 from aggregate exposure to sethoxydim residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography with flame photometric detection in the sulfur mode; BASF Wyandotte Corporation’s Method No. 30; 3/15/82; MRID 44864501; Method I, Pesticide Analytical Methods Vol. II) is available to enforce these oilseed tolerances. B. International Residue Limits There are no CODEX, Canadian or Mexican maximum residue limits (MRLs) established on the commodities associated with this petition. V. Conclusion Therefore, tolerances are established for combined residues of sethoxydim, 2[1-(ethoxyimino)butyl]-5-[2(ethylthio)propyl]-3-hydroxy-2cyclohexen-1-one, and its metabolites containing the 2-cyclohexen-1-one moiety, in or on crambe, meal at 40.0 ppm; crambe, seed at 35.0 ppm; cuphea, seed at 35.0 ppm; echium, seed at 35.0 ppm; gold of pleasure, meal at 40.0 ppm; gold of pleasure, seed at 35.0 ppm; hare’s ear mustard, seed at 35.0 ppm; lesquerella, seed at 35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; and sweet rocket, seed at 35.0 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA 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, 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 E:\FR\FM\09JYR1.SGM 09JYR1 Federal Register / Vol. 73, No. 132 / Wednesday, July 9, 2008 / Rules and Regulations 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this 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) (Public Law 104–4). 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), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). dwashington3 on PRODPC61 with RULES VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). VerDate Aug<31>2005 15:16 Jul 08, 2008 Jkt 214001 39261 List of Subjects in 40 CFR Part 180 * Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. [FR Doc. E8–15519 Filed 7–8–08; 8:45 am] * * * * BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY Dated: June 30, 2008. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. 40 CFR Part 180 [EPA–HQ–OPP–2007–0096; FRL–8372–6] I Therefore, 40 CFR chapter I is amended as follows: Gamma-cyhalothrin; Pesticide Tolerances PART 180—[AMENDED] AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. 1. The authority citation for part 180 continues to read as follows: I SUMMARY: This regulation establishes tolerances for residues of GammaI 2. Section 180.412 is amended by cyhalothrin in or on all food alphabetically adding the following commodities (other than those already commodities to the table in paragraph covered by a higher tolerance as a result (a) to read as follows: of use on growing crops) in foodhandling establishments where food § 180.412 Sethoxydim; tolerances for products are held, processed or residues. prepared, pistachio and okra. Pytech (a) * * * Chemicals GmbH and Interregional Research Project No. 4 (IR-4) requested Commodity Parts per million this tolerance under the Federal Food, * * * * * Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July Crambe, meal ................. 40.0 9, 2008. Objections and requests for Crambe, seed ................. 35.0 hearings must be received on or before * * * * * September 8, 2008, and must be filed in Cuphea, seed ................. 35.0 accordance with the instructions * * * * * provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY Echium, seed .................. 35.0 INFORMATION). Authority: 21 U.S.C. 321(q), 346a and 371. * * * * * Gold of pleasure, meal ... Gold of pleasure, seed ... * * * * 40.0 35.0 * Hare’s ear mustard, seed * * * * 35.0 * Lesquerella, seed ........... * * * * 35.0 * * 35.0 35.0 * Milkweed, seed ............... Mustard, seed ................. * * * * 35.0 35.0 * Oil radish, seed .............. * * * * 35.0 * Poppy, seed .................... * * * * 35.0 * Sesame, seed ................. * * * * 35.0 * Sweet rocket, seed ......... * * * * 35.0 * Lunaria, seed .................. Meadowfoam, seed ........ * * * PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–0096. To access the electronic docket, go to https:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), ADDRESSES: E:\FR\FM\09JYR1.SGM 09JYR1

Agencies

[Federal Register Volume 73, Number 132 (Wednesday, July 9, 2008)]
[Rules and Regulations]
[Pages 39256-39261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15519]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0893; FRL-8370-9]


Sethoxydim; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of sethoxydim and its metabolites containing the 2-cyclohexen-1-one 
moiety, in or on various oilseed commodities. Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 9, 2008. Objections and 
requests for hearings must be received on or before September 8, 2008, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0893. To access the 
electronic docket, go to https://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at https://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).

[[Page 39257]]

     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at https://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0893 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before September 8, 2008.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0893, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of September 28, 2007 (72 FR 55204) (FRL-
8147-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E7232) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 
40 CFR 180.412 be amended by establishing tolerances for combined 
residues of the herbicide sethoxydim, 2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites 
containing the 2-cyclohexen-1-one moiety (calculated as the herbicide), 
in or on cuphea, seed at 35.0 parts per million (ppm); echium, seed at 
35.0 ppm; gold of pleasure, seed at 35.0 ppm; gold of pleasure, meal at 
40.0 ppm; hare's ear mustard, seed at 35.0 ppm; lesquerella, seed at 
35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; 
milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed 
at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; sweet 
rocket, seed at 35.0 ppm; crambe, seed at 35.0 ppm; and crambe, meal at 
40.0 ppm. That notice referenced a summary of the petition prepared by 
BASF, the registrant, on behalf of IR-4, which is available to the 
public in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 
tolerances for combined residues of sethoxydim and its metabolites 
containing the 2-cyclohexen-1-one moiety on crambe, meal at 40.0 ppm; 
crambe, seed at 35.0 ppm; cuphea, seed at 35.0 ppm; echium, seed at 
35.0 ppm; gold of pleasure, meal at 40.0 ppm; gold of pleasure, seed at 
35.0 ppm; hare's ear mustard, seed at 35.0 ppm; lesquerella, seed at 
35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; 
milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed 
at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; and 
sweet rocket, seed at 35.0 ppm. EPA's assessment of exposures and risks 
associated with establishing these tolerances 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 acute toxicity data indicate that sethoxydim is minimally toxic 
via oral, dermal and inhalation routes of exposure. It is neither 
irritating to the eye nor the skin. With repeated dosing, the primary 
target organ for this chemical is the liver. In the chronic toxicity 
study in dogs, there were significantly increased absolute and

[[Page 39258]]

relative liver weights accompanied by supportive clinical chemistry and 
histopathology. Dose-related clinical chemistry abnormalities were 
observed in both sexes and included increased alkaline phosphatase and 
aspartate aminotransferase (ALT) and decreased albumin and cholesterol 
synthesis. Dose-related histopathologic lesions were found in the 
liver, spleen and bone marrow. A mild hepatocellular cytoplasmic 
alteration was found in males at all doses and in females at the mid 
and high doses. Adverse liver effects were also observed via the oral 
route in mice and via the inhalation route in rats. There was no 
evidence of carcinogenicity in studies in rats and mice and no evidence 
of mutagencity, immunotoxicity or endocrine disruption in the toxicity 
database for sethoxydim. In the prenatal developmental studies in rats 
and rabbits and reproductive toxicity study in rats, the primary 
effects noted in the young were fetal skeletal variations and decreases 
in body weight. Although effects suggestive of neurotoxicity were noted 
in adult and young rats in the developmental and/or reproductive 
toxicity studies, EPA has concluded that sethoxydim is not a neurotoxic 
chemical. The weight of evidence EPA considered in making this 
determination is discussed in more detail in Unit III.D.3.ii.
    Specific information on the studies received and the nature of the 
toxic effects caused by sethoxydim as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found in the final rule 
published in the Federal Register of September 29, 2003 (68 FR 55858) 
(FRL-7238-6)(https://www.epa.gov/EPA-PEST/2003/September/Day-29/
p24562.htm).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the NOAEL in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD) 
approach is sometimes used for risk assessment. Uncertainty/safety 
factors (UFs) are used in conjunction with the POD to take into account 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. Safety is assessed for 
acute and chronic dietary risks by comparing aggregate food and water 
exposure to the pesticide to the acute population adjusted dose (aPAD) 
and chronic population adjusted dose (cPAD). The aPAD and cPAD are 
calculated by dividing the POD by all applicable UFs. Aggregate short-
term, intermediate-term, and chronic-term risks are evaluated by 
comparing food, water, and residential exposure to the POD to ensure 
that the margin of exposure (MOE) called for by the product of all 
applicable UFs is not exceeded. This latter value is referred to as the 
Level of Concern (LOC).
    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 
greater than that 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 https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sethoxydim used for 
human risk assessment can be found at https://www.regulations.gov in the 
document Sethoxydim: Amended human health risk assessment to support 
uses on the Rapeseed Crop Subgroup 20A at page 10 in docket ID number 
EPA-HQ-OPP-2007-0893.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sethoxydim, EPA considered exposure under the petitioned-
for tolerances as well as all existing sethoxydim tolerances in 40 CFR 
180.412. EPA assessed dietary exposures from sethoxydim 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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA assumed that 100 
percent of all crops with existing or pending tolerances are treated 
with sethoxydim and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed that 100 
percent of all crops with existing or pending tolerances are treated 
with sethoxydim and contain tolerance-level residues.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA classified sethoxydim as ``not likely to be 
carcinogenic to humans''; therefore, an exposure assessment for 
evaluating cancer risk is not needed for this chemical.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for sethoxydim. Tolerance level residues and 100 PCT 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 sethoxydim in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of sethoxydim. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of sethoxydim for acute 
exposures are estimated to be 130 parts per billion (ppb) for surface 
water and 1.5 ppb for ground water; and for chronic exposures for non-
cancer assessments are estimated to be 16 ppb for surface water and 1.5 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 130 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 16 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Sethoxydim is currently registered for the following uses that 
could result in residential exposures: Ornamentals and flowering 
plants, recreational areas, and buildings/structures (outdoor). EPA 
assessed residential handler and

[[Page 39259]]

postapplication exposures using the following assumptions:
    Homeowners who apply sethoxydim to ornamental gardens and turf may 
be exposed for short-term durations via the dermal and inhalation 
routes. Dermal endpoints of concern were not identified for sethoxydim; 
therefore, dermal exposure and risk assessments are not appropriate. 
Short-term inhalation exposure was assessed for residential handlers 
who mix, load and apply liquid sethoxydim products using low-pressure 
hand wands, backpack sprayers and garden hose-end sprayers.
    Sethoxydim can be used in areas, such as home lawns, that may be 
frequented by adults and children. There is potential for dermal 
exposure of adults and children as well as incidental oral exposure of 
children following application of sethoxydim to such areas. Post-
application inhalation exposure of adults and children is expected to 
be negligible. Since there are no dermal endpoints of concern for 
sethoxydim, only post-application incidental oral exposure of children 
was assessed. EPA assessed incidental oral exposure of toddlers from 
hand-to-mouth, object-to-mouth and incidental soil ingestion activities 
using Standard Operating Procedures for Residential Exposure 
Assessments.
    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 sethoxydim to share a common mechanism of 
toxicity with any other substances, and sethoxydim does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
sethoxydim does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://
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 FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicity database for sethoxydim includes rat and rabbit developmental 
toxicity studies and a 2-generation reproduction toxicity study in 
rats. There was no evidence of increased quantitative or qualitative 
susceptibility of in utero rabbit fetuses following exposure to 
sethoxydim in the rabbit developmental study; however, evidence of 
increased susceptibility was noted in the rat developmental and 
reproduction toxicity studies as described below:
    There was some evidence of qualitative susceptibility in the rat 
developmental study with the occurrence of more severe effects in the 
fetuses (delayed ossification and tail abnormalities) than in the 
maternal animals (transient clinical signs including: Irregular gait 
and decreased activity) at the same dose. The degree of concern for 
increased susceptibility in this study is low and there are no residual 
uncertainties for the following reasons: The effects in the pups were 
of low incidence and only observed at a high dose that is considered to 
be close to a limit dose. In addition, these effects were seen in the 
presence of clear maternal toxicity and clear NOAELs and LOAELs were 
established for both maternal and developmental toxicities.
    In the 2-generation reproduction study in rats, pups showed 
decreases in body weight (11 to 13%) during lactation at the high dose. 
At the same dose, adult female animals exhibited body weight losses (8 
to 10%) that are considered too small to qualify as an adverse effect. 
The determination that body weight effects occurred in pups at a dose 
that did not result in maternal toxicity is technically an indication 
of quantitative susceptibility. However, the degree of concern for the 
body weight changes in pups is low, since the weight changes are 
considered minimal and the differences observed in body weight losses 
between the adult and young animals are marginal. Characterization of 
the body weight changes as an adverse effect in the pups is considered 
conservative (protective).
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for sethoxydim is complete.
    ii. Sethoxydim is not considered to be a neurotoxic chemical and 
there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity. Clinical signs suggestive of 
neurotoxicity (including irregular gait, decreased activity, excessive 
salivation, and anogenital staining) were observed in adult rats in the 
developmental toxicity study. Because the clinical signs occurred 
shortly after dosing, only occurred at very high treatment doses (over 
one half the limit dose) and were transitory, it is unlikely that the 
signs observed are the result of a primary systemic effect on the 
nervous system but, rather, are reflective of the general toxicity at a 
high dose. An increased incidence of fetal skeletal variations due to 
delayed ossification was seen in young rats in the developmental and 
reproductive toxicity studies. In the rat prenatal study, tail 
abnormalities (filamentous tail or lack of a tail) were noted. These 
abnormalities were observed at a very low incidence and at high 
treatment doses. In the 2-generation reproduction study in rats, a tail 
anomaly (short, thread-like tail, no anal opening, hindlimbs curved 
toward central midline) was found in one pup in the F2b generation (1/
344 total pups; in 1/4 litters). Tail abnormalities are sometimes 
thought to relate to central nervous system (CNS) malformations; 
however, in this case, these tail abnormalities are not likely to be 
the result of a primary neural tube effect. In the rat prenatal study, 
there is no description of any effect on neural tube-derived 
structures. No other effects suggestive of neurotoxicity were seen in 
toxicology studies conducted with sethoxydim. Furthermore, 
cyclohexones, the class of compounds that includes sethoxydim, are not 
known to cause neurotoxicity or developmental malformations of the 
nervous system. Based on the weight of the evidence, EPA concluded that 
sethoxydim is not neurotoxic.
    iii. There is no evidence that sethoxydim results in increased 
susceptibility in in utero rabbits in the prenatal developmental study. 
Although there is qualitative evidence of increased susceptibility in 
the prenatal developmental study in rats and equivocal evidence of 
quantitative susceptibility in the 2-generation

[[Page 39260]]

reproduction study in rats, the degree of concern is low, and the 
Agency did not identify any residual uncertainties after establishing 
toxicity endpoints and traditional UFs to be used in the risk 
assessment of sethoxydim.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed 
assuming 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to sethoxydim in drinking water. EPA used similarly 
conservative assumptions to assess postapplication exposure of children 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by sethoxydim.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
sethoxydim will occupy 17% of the aPAD for children, 1 to 2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
sethoxydim from food and water will utilize 94% of the cPAD for 
children, 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
sethoxydim is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Sethoxydim 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 sethoxydim, except residential 
inhalation exposures. It is not appropriate to aggregate dietary (i.e., 
oral) exposures and inhalation exposures because the toxic effects 
identified for the oral and inhalation exposure pathways differ.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in an aggregate MOE of 
1,300 for children 1 to 2 years old (toddlers). The aggregate MOE for 
children includes food, drinking water and post-application incidental 
oral exposures from entering turf areas previously treated with 
sethoxydim. Adult residential handler MOEs, based on inhalation 
exposure of adults who mix, load and apply liquid sethoxydim products 
using low-pressure hand wands, backpack sprayers or garden hose-end 
sprayers, range from 1.4 x 10\6\ to 1.6 x 10\6\, with hose-end sprayers 
resulting in the lowest MOE. As noted in the previous paragraph, it is 
not appropriate to aggregate chronic exposure from food and water with 
inhalation exposures. Post-application inhalation exposure of adults 
and children is expected to be negligible.
    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). Sethoxydim is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to sethoxydim through food and water, which has already been addressed, 
and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. EPA has classified 
sethoxydim into the category ``Not Likely to be Carcinogenic to 
Humans.'' Sethoxydim is not expected to pose a cancer risk.
    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 sethoxydim residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with flame 
photometric detection in the sulfur mode; BASF Wyandotte Corporation's 
Method No. 30; 3/15/82; MRID 44864501; Method I, Pesticide Analytical 
Methods Vol. II) is available to enforce these oilseed tolerances.

B. International Residue Limits

    There are no CODEX, Canadian or Mexican maximum residue limits 
(MRLs) established on the commodities associated with this petition.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
sethoxydim, 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-
2-cyclohexen-1-one, and its metabolites containing the 2-cyclohexen-1-
one moiety, in or on crambe, meal at 40.0 ppm; crambe, seed at 35.0 
ppm; cuphea, seed at 35.0 ppm; echium, seed at 35.0 ppm; gold of 
pleasure, meal at 40.0 ppm; gold of pleasure, seed at 35.0 ppm; hare's 
ear mustard, seed at 35.0 ppm; lesquerella, seed at 35.0 ppm; lunaria, 
seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; milkweed, seed at 35.0 
ppm; mustard, seed at 35.0 ppm; oil radish, seed at 35.0 ppm; poppy, 
seed at 35.0 ppm; sesame, seed at 35.0 ppm; and sweet rocket, seed at 
35.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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, 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

[[Page 39261]]

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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: June 30, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.412 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.412  Sethoxydim; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Crambe, meal.........................................               40.0
Crambe, seed.........................................               35.0
                                * * * * *
Cuphea, seed.........................................               35.0
                                * * * * *
Echium, seed.........................................               35.0
                                * * * * *
Gold of pleasure, meal...............................               40.0
Gold of pleasure, seed...............................               35.0
                                * * * * *
Hare's ear mustard, seed.............................               35.0
                                * * * * *
Lesquerella, seed....................................               35.0
                                * * * * *
Lunaria, seed........................................               35.0
Meadowfoam, seed.....................................               35.0
                                * * * * *
Milkweed, seed.......................................               35.0
Mustard, seed........................................               35.0
                                * * * * *
Oil radish, seed.....................................               35.0
                                * * * * *
Poppy, seed..........................................               35.0
                                * * * * *
Sesame, seed.........................................               35.0
                                * * * * *
Sweet rocket, seed...................................               35.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-15519 Filed 7-8-08; 8:45 am]
BILLING CODE 6560-50-S