美国修订稀禾定限量要求（Sethoxydim; Pesticide Tolerances）_中国食品网

【发布单位】 EPA
【发布文号】
【发布日期】 2015-06-15
【生效日期】 2015-06-15
【废止日期】
【替代法规】
【效　　力】
【食品伙伴网解读】 2015年6月15日，美国环保署发布一条最终条例，修订稀禾定多种商品内部或表面的残留限量要求，本规则于 2015年 6月 15日起生效，反对或听证要求按 40 CFR§178的说明在 2015年 8月 14日前提交。
美国联邦法规 40 CFR§180.412部分修订对稀禾定的残留限量要求如下：

产品英文名称

产品中文名称

限量要求（ppm）

Alfalfa, forage	苜蓿饲草	40
Alfalfa, hay	带壳杏仁	2.0
Apricot	苹果湿果渣	0.8
Asparagus	肉质豆类	15
Beet, sugar, molasses	甜菜头	3.0
Berry, low growing, subgroup 13-07H, except strawberry	琉璃苣粕	40
Buckwheat, flour	荞麦颗粒	19
Bushberry subgroup 13-07B	金盏花粕	20
Caneberry subgroup 13-07A	芥花油粕	40
Castor oil plant, meal	牛脂肪	0.2
Cattle, meat	牛肉副产品	1.0
Cherry, sweet	酸樱桃	0.2
Chinese tallowtree, meal	柑橘类干浆	1.5
Clover, forage	三叶草干草	55
Coriander, leaves	饲料玉米	2.0
Corn, field, grain	饲料玉米干草	2.5
Corn, sweet, forage	去皮的甜玉米穗	0.4
Corn, sweet, stover	棉籽亚组 20C	nseed="" subgroup="" style="word-break: break-all;"> 5.0
Cowpea, forage	豇豆干草	50
Crambe, meal	萼距花粕	40
Dillweed, fresh leaves	蓝蓟粕	40
Egg	大戟粕	20
Evening primrose, meal	亚麻籽粕	40
Fruit, citrus, group 10-10	仁果类水果，组 11-10	0.2
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F	山羊脂肪	0.2
Goat, meat	山羊肉副产品	1.0
Gold of pleasure, meal	葡萄干	2.0
Hare's ear mustard, meal	猪脂肪	0.2
Hog, meat	猪肉副产品	1.0
Horse, fat	马肉	0.2
Horse, meat byproducts	荷荷巴粕	20
Juneberry	雷斯克勒粕	40
Lingonberry	新月贝属粕	40
Meadowfoam, meal	奶	0.5
Milkweed, meal	芥菜粕	40
Nectarine	黑芝麻粕	20
Nut, tree, group 14	莱菔粕	40
Pea and bean, dried shelled, except soybean, subgroup 6C	紫花豌豆干草	40
Pea, field, vines	肉质豌豆	10
Peach	花生	25
Peppermint, tops	阿月浑子	0.2
Poppy seed, meal	马铃薯全粉 /片	8.0
Potato waste, processed	家禽脂肪	0.2
Poultry, meat	家禽肉副产品	2.0
Radish, tops	油菜籽粕	40
Rapeseed subgroup 20A	玫瑰果粕	20
Safflower, seed	沙龙白珠树	5.0
Sesame, meal	绵羊脂肪	0.2
Sheep, meat	绵羊肉副产品	1.0
Soybean, hay	大豆籽	16
Spearmint, tops	草莓	10
Stokes aster, meal	向日葵粕	20
Sunflower subgroup 20B, except safflower	甜芝麻菜粕	40
Tallowwood, meal	茶油作物粕	20
Turnip, tops	芸苔属叶菜，组 5	5.0
Vegetable, bulb, group 3-07	瓜类蔬菜，组 9	4.0
Vegetable, fruiting, group 8-10	叶菜，除了芸苔属，组 4	4.0
Vegetable, root and tuber, group 1	斑鸠菊粕	nia="" style="word-break: break-all;"> 20

另外，区域性的残留限量要求如下：

Artichoke, globe	朝鲜蓟	5.0
Fescue, forage	羊茅草饲料	7.0
Rhubarb	大黄	0.3
Fescue, hay	羊茅草干草	4.0

　　ACTION

　　Final Rule.

　　SUMMARY

　　This regulation establishes tolerances for residues of sethoxydim in or on multiple commodities that are identified and discussed later in this docu ment. In addition, this regulation removes existing tolerances for residues of sethoxydim in or on several commodities identified later in this docu ment that are superseded by this action. Interregio nal Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

　　TABLE OF CONTENTS

　　DATES:

　　ADDRESSES:

　　FOR FURTHER INFORMATION CONTACT:

　　SUPPLEMENTARY INFORMATION:

　　I. General Information

　　A. Does this action apply to me?

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

　　C. How can I file an objection or hearing request?

　　II. Summary of Petitioned-For Tolerance

　　III. Aggregate Risk Assessment and Determination of Safety

　　A. Toxicological Profile

　　B. Toxicological Points of Departure/Levels of Concern

　　C. Exposure Assessment

　　D. Safety Factor for Infants and Children

　　E. Aggregate Risks and Determination of Safety

　　IV. Other Considerations

　　A. Analytical Enforcement Methodology

　　B. Internatio nal Residue Limits

　　C. Respo nse to Comments

　　D. Revisions to Petitioned-For Tolerances

　　E. Trade Considerations

　　V. Conclusion

　　VI. Statutory and Executive Order Reviews

　　VII. Co ngressional Review Act

　　List of Subjects in 40 CFR Part 180

　　PART 180—[AMENDED]

　　TABLES

　　Table 1—Summary of Toxicological Doses and Endpoints for Sethoxydim for Use in Human Health Risk Assessment

　　DATES:

　　This regulation is effective June 15, 2015. Objections and requests for hearings must be received on or before August 14, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

　　ADDRESSES:

　　The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0161, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Enviro nmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Co nstitution Ave. NW., Washington, DC 20460-0001.

　　The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Mo nday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additio nal information a bout the docket available at http://www.epa.gov/dockets.

　　FOR FURTHER INFORMATION CONTACT:

　　Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Enviro nmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

　　SUPPLEMENTARY INFORMATION:

　　I. General Information

　　A. Does this action apply to me?

　　You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this docu ment applies to them. Potentially affected entities may include:

　　Crop production (NAICS code 111).

　　Animal production (NAICS code 112).

　　Food manufacturing (NAICS code 311).

　　Pesticide manufacturing (NAICS code 32532).

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

　　You may access a frequently updated electro nic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

　　C. How can I file an objection or hearing request?

　　Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0161 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 14, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

　　In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Co nfidential Business Information (CBI)) for inclusion in the public docket. Information not marked co nfidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0161, by one of the following methods:

　　Federal eRulemaking Portal: http://www.regulations.gov. Follow the o nline instructions for submitting comments. Do not submit electro nically any information you co nsider to be CBI or other information whose disclosure is restricted by statute.

　　Mail: OPP Docket, Enviro nmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

　　Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additio nal instructions on commenting or visiting the docket, along with more information a bout dockets generally, is available at http://www.epa.gov/dockets.

　　II. Summary of Petitioned-For Tolerance

　　In the Federal Register of May 23, 2014 (79 FR 29729) (FRL-9910-29), EPA issued a docu ment pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8239) by Interregio nal Research Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road East, Suite 201 W, 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 me tabolites co ntaining the 2-cyclohexen-1-one moiety (calculated as the herbicide sethoxydim) in or on raw agricultural commodities (RACs): Bushberry subgroup 13-07B at 5.0 parts per million (ppm); caneberry subgroup 13-07A at 5.0 ppm; berry, low growing subgroup 13-07H, except strawberry at 2.5 ppm; fescue forage at 6.0 ppm; fescue, hay at 4.0 ppm; fruit, citrus group 10-10 at 0.5 ppm; fruit, pome group 11-10 at 0.2 ppm; fruit, small, vine climbing subgroup 13-07F, except fuzzy kiwifruit at 1.0 ppm; rapeseed subgroup 20A at 35 ppm; sunflower subgroup 20B, except safflower, seed at 7.0 ppm; cotto nseed subgroup 20C at 5.0 ppm; vegetable, bulb group 3-07 at 1.0 ppm; and vegetable, fruiting group 8-10 at 4.0 ppm. That docu ment referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's respo nse to this comment is discussed in Unit IV.C.

　　ba sed upon review of the data supporting the petition, EPA has made certain modifications, including revising certain petitioned-for tolerance levels, setting meal tolerances for various oilseed crop subgroups to cover potential processed commodities, and updating crop definitions as well as the tolerance ex pression for sethoxydim to co nform to current EPA policies. The reasons for these changes are explained in Unit IV.D.

　　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) o nly if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reaso nable 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 occupatio nal exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special co nsideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reaso nable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . . ”

　　Co nsistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for sethoxydim including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with sethoxydim follows.

　　A. Toxicological Profile

　　EPA has e valuated the available toxicity data and co nsidered their validity, completeness, and reliability as well as the relatio nship of the results of the studies to human risk. EPA has also co nsidered available information co ncerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

　　Toxicological tests in animals (rats, mice, and dog) show that the target organ of sethodydim toxicity is the liver. Toxic effects are characterized by increased liver weight; hypertrophy; fatty degeneration; hepatocyte swelling; increased serum bilirubin, alkaline phosphatase, aspartateaminotransferase, and alanine aminotransferase levels; focal granulomatous inflammation; and eosinophilic foci. Liver toxicity was observed by exposure through both the oral and inhalation routes.

　　Findings other than liver toxicity were also observed. In a subchro nic rat study, decreased body weight, body weight gain, and food efficiency were noted at a lower dose than liver toxicity. In a chro nic dog toxicity study, increased hemosiderosis in the spleen and depressed myeloid erythropoiesis in the sternal bone marrow were observed. Interstitial fibrosis and heart failure cells in lung in female rats were observed in the chro nic toxicity/carcinogenicity study in rats.

　　In the developmental rat study, maternal toxicity was observed, as evidenced by an irregular gait, decreased activity, excessive salivation, and anogenital staining at a dose greater than half the limit dose and at the limit dose. All clinical signs reported were transient, with the exception of the anogenital staining, which did not reverse.

　　Developmental toxicity occurred at the same dose as maternal toxicity in rats and included decreased fetal weights, filamentous tail, and lack of tail due to the absence of sacral and/or caudal vertebrae, and delayed ossification in the hyoids, vertebral centrum and/or transverse processes, sternebrae and/or me tatarsals, and pubes. No maternal toxicity was noted in rabbits at 400 milligrams per kilogram (mg/kg)/day, and developmental toxicity was noted at 400 mg/kg/day (NOAEL = 320 mg/kg/day) as an increase in the incidence of incompletely ossified 6th sternebrae. In the reproduction study, no parental or reproductive toxicity was observed at 150 mg/kg/day (highest dose tested), but offspring toxicity was noted at this dose as decreased pup weight in the F 1a, F 1b, and F 2b generation during lactation (no-observed-adverse-effect-level (NOAEL) = 30 mg/kg/day). There is a low co ncern for these findings, since the seleced points of departure are protective; there is low co ncern for pre- and/or postnatal toxicity resulting from exposure to sethoxydim.

　　Dermal toxicity was not observed at the limit dose in a 21-day dermal study in rabbits. ba sed on the lack of sensitization in treated guinea pigs, sethoxydim is not a skin sensitizer. No eye or dermal irritation were noted in rabbits. No neurotoxicity or other toxicity was observed at the highest dose tested (207 mg/kg/day) in the subchro nic neurotoxicity test in rats.

　　There was no evidence of carcinogenicity in rats and mice, and no evidence of genotoxicity. Sethoxydim is classified as “Not Likely to Be Carcinogenic to Humans.” Specific information on the studies received and the nature of the adverse effects caused by sethoxydim, as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies, can be found at http://www.regulations.gov in docu ment “Sethoxydim: Human Health Risk Assessment for Registration Review and to Support the Section 3 Registration of Proposed Uses on High Bush Blueberry and Fine Fescue Grasses”, dated February 3, 2015 at page 40 in docket ID number EPA-HQ-OPP-2014-0161-000x.

　　B. Toxicological Points of Departure/Levels of Concern

　　o nce a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of co ncern to use in e valuating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed ba sed on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of co ncern are identified (the LOAEL). Uncertainty/safety factors are used in co njunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete des cription of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

　　A summary of the toxicological endpoints for sethoxydim used for human risk assessment is shown in Table 1 of this unit.

　　Table 1—Summary of Toxicological Doses and Endpoints for Sethoxydim for Use in Human Health Risk Assessment Back to Top

　　Exposure/scenarioPoint of departure and uncertainty/safety factorsRfD, PAD, LOC for risk assessmentStudy and toxicological effects

　　Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-respo nse data and used to mark the beginning of extrapolation to determine risk associated with lower enviro nmentally relevant human exposures. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UF A= extrapolation from animal to human (interspecies). UF DB= to account for the absence of data or other data deficiency. UF H= potential variation in sensitivity among members of the human population (intraspecies). UF L= use of a LOAEL to extrapolate a NOAEL. UF S = use of a short-term study for long-term risk assessment. Human equivalent co ncentrations (HECs), Human equivalent dose (HED).

　　Acute dietary (females 13-49 years of age)NOAEL = 180 mg/kg/day UF A= 10x UF H= 10x FQPA SF =1xAcute RfD = aPAD = 1.8 mg/kg/dayRat Developmental Toxicity Developmental LOAEL = 650 mg/kg/day ba sed on decreased fetal body weight, tail abnormalities, and delayed ossification Tail abnormalities were co nsidered an acute effect.

　　Acute dietary (general population including infants and children)NOAEL = 180 mg/kg/day UF A= 10x UF H= 10x FQPA SF = 1xAcute RfD = aPAD = 1.8 mg/kg/dayRat Developmental Toxicity Maternal LOAEL = 650 mg/kg/day ba sed on irregular gait that was observed in 12/34 dams on the first day of dosing.

　　Chro nic dietary (all populations)NOAEL = 14 mg/kg/day UF A= 10x UF H=10x FQPA SF =1xChro nic RfD = cPAD = 0.14 mg/kg/dayMouse Carcinogenicity Study LOAEL = 41 mg/kg/day ba sed on liver hypertrophy and fatty degeneration.

　　Incidental oral short-term (1 to 30 days)NOAEL = 180 mg/kg/day UF A= 10x UF H= 10x FQPA SF = 1xResidential LOC for MOE = 100Rat Developmental Toxicity Maternal LOAEL = 650 mg/kg/day ba sed on irregular gait, decreased activity, excessive salivation, and anogenital staining.

　　Short- and Intermediate term Inhalatio nInhalation study NOAEL = 0.3 mg/L UF A= 3x UF H= 10x FQPA SF = 1x HEC = 0.932 mg/L/day (residential handler) HED = 26.7 mg/kg/day (residential handler) or 39.8-138.9 mg/kg/day (occupatio nal handler)Residential LOC for MOE = 30 Occupatio nal LOC for MOE = 30Rat 28-day Inhalation Study LOAEL = 2.4 mg/L ba sed on increased liver weight, increased total serum bilirubin, and increased incidence of slight centrilobular hepatocyte swelling.

　　Cancer (oral, dermal, inhalation)“Not Likely to Be Carcinogenic to Humans” ba sed on the lack of evidence of carcinogenicity in rats and mice.

　　C. Exposure Assessment

　　1. Dietary exposure from food and feed uses. In e valuating dietary exposure to sethoxydim, EPA co nsidered 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 co ncern occurring as a result of a 1-day or single exposure. Such effects were identified for sethoxydim. In co nducting the acute dietary exposure assessment for sethoxydim, EPA used the Dietary Exposure e valuation Model software with the Food Commodity Intake Databa se (DEEM-FCID) Version 3.16. This software uses 2003-2008 food co nsumption data from the U.S. Department of Agriculture's (USDA's) Natio nal Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). A partially refined acute analysis was performed ba sed on tolerance-level residues; percent crop treated (PCT) estimates for most agricultural uses of sethoxydim were applied, and DEEM TM default processing factors were applied to account for processed commodities.

　　ii. Chro nic exposure. In co nducting the chro nic dietary exposure assessment for sethoxydim, EPA used DEEM-FCID Version 3.16 in which the software uses 2003-2008 food co nsumption data from the USDA's NHANES/WWEIA. A partially refined chro nic dietary exposure assessment was conducted, which used PCT data, but the overall dietary assessment represents high-end exposure because tolerance-level residues were used for food and bounding modeled residues for drinking water. Anticipated residues (ba sed on maximum theoretical diets) were used for livestock commodities.

　　iii. Cancer. ba sed on the data summarized in Unit III.A., EPA has co ncluded that sethoxydim is not likely to pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

　　iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demo nstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

　　Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chro nic dietary risk o nly if:

　　Co ndition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to co ntain the pesticide residue.

　　Co ndition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

　　Co ndition c: Data are available on pesticide use and food co nsumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic e valuation of any estimates used. Toprovide for the periodic e valuation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

　　The Agency estimated the PCT for existing uses. For acute dietary risk assessment for sethoxydim the following maximum PCT estimates were used: Alfalfa 2.5%; almo nds 5%; apples 2.5%; apricots 10%; artichokes 2.5%; asparagus 10%; beans, green 15%; blueberries 10%; broccoli 5%; cabbage 10%; caneberries 10%; canola 2.5%; cantaloupes 25%; carrots 5%; cauliflower 10%; celery 2.5%; cherries 2.5%; corn 2.5%; cotton 2.5%; cucumbers 10%; dry beans/peas 35%; eggplant 10%; fallow 2.5%; garlic 5%; grapefruit 2.5%; grapes 5%; hazelnuts 2.5%; lettuce 10%; oats 2.5%; o nions 15%; oranges 5%; peaches 2.5%; peanuts 10%; pears 2.5%; peas, green 15%; pecans 2.5%; peppers 15%; pistachios 2.5%; plums/prunes 2.5%; potatoes 5%; pumpkins 10%; soybeans 2.5%; spinach 2.5%; squash 10%; strawberries 10%; sugar beets 5%; sunflowers 10%; sweet corn 5%; tobacco 10%; tomatoes 5%; walnuts 5%; watermelons 20%; wheat 2.5%.

　　For chro nic dietary risk assessment, the following average PCT estimates for sethoxydim were used: Alfalfa 1%; almo nds 2.5%; apples 1%; apricots 2.5%; artichokes 2.5%; asparagus 5%; beans, green 10%; blueberries 5%; broccoli 2.5%; cabbage 5%; caneberries 5%; canola 2.5%; cantaloupes 5%; carrots 2.5%; cauliflower 5%; celery 2.5%; cherries 2.5%; corn 1%; cotton 1%; cucumbers 5%; dry beans/peas 30%; eggplant 5%; fallow 1%; garlic 2.5%; grapefruit 2.5%; grapes 2.5%; hazelnuts 2.5%; lettuce 2.5%; oats 1%; o nions 5%; oranges 2.5%; peaches 1%; peanuts 5%; pears 2.5%; peas, green 5%; pecans 2.5%; peppers 5%; pistachios 1%; plums/prunes 1%; potatoes 2.5%; pumpkins 5%; soybeans 1%; spinach 2.5%; squash 5%; strawberries 2.5%; sugar beets 2.5%; sunflowers 5%; sweet corn 2.5%; tobacco 5%; tomatoes 2.5%; walnuts 2.5%; watermelons 10%; wheat 1%.

　　In most cases, EPA uses available data from United States Department of Agriculture/Natio nal Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the Natio nal Pesticide Use Databa se for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chro nic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

　　The Agency believes that the three co nditions discussed in Unit III.C.1.iv. have been met. With respect to Co ndition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reaso nably certain that the percentage of the food treated is not likely to be an underestimation. As to Co nditions b and c, regio nal co nsumption information and co nsumption information for significant subpopulations is taken into account through EPA's computer-ba sed model for e valuating the exposure of significant subpopulations including several regio nal groups. Use of this co nsumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reaso nably certain that no regio nal population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through natio nal food co nsumption surveys, EPA does not have available reliable information on the regio nal co nsumption of food to which Sethoxydim may be applied in a particular area.

　　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 http://www.epa.gov/oppefed1/models/water/index.htm.

　　ba sed on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) Surface Water Calculator (SWCC Version 1.106), Surface Water Provisio nal Cranberry Model and Tier 1 mode of the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water co ncentrations (EDWCs) of sethoxydim for acute exposures are estimated to be 79.6 parts per billion (ppb) for surface water and 0.565 ppb for ground water.

　　For chro nic exposures for non-cancer assessments are estimated to be 13.9 ppb for surface water and 0.51 ppb for ground water.

　　Modeled estimates of drinking water co ncentrations were directly entered into the dietary exposure model.

　　For acute dietary risk assessment, the water co ncentration value of 79.6 ppb was used to assess the co ntribution to drinking water.

　　For chro nic dietary risk assessment, the water co ncentration of value 13.9 ppb was used to assess the co ntribution to drinking water.

　　3. From non-dietary exposure. The term “residential exposure” is used in this docu ment to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick co ntrol on pets).

　　Sethoxydim is currently registered for the following uses that could result in residential exposures: Turf (including lawns, golf courses, recreatio nal parks, and sod farms) and ornamentals. Short-term exposure to sethoxydim may occur via the dermal and inhalation routes for adults using sethoxydim products in residential settings. Since no dermal hazard was identified, o nly inhalation exposures were assessed for residential applicators. In addition, children may potentially be exposed orally in post-application turf scenarios. Intermediate- or long-term exposures are not expected due to the intermittent nature of applications by homeowners.

　　EPA assessed residential exposure using the following assumptions: Since no dermal hazard was identified in the toxicity databa se for sethoxydim, a quantitative residential post-application dermal risk assessment is not required and was not completed. Post-application inhalation exposures while performing activities in previously treated turf or ornamentals are not expected, primarily due to the very low vapor pressure (1.6 × 10 ?7 mm Hg at 25 ° C) and the expected dilution in outdoor air after an application has occurred. Therefore, post-application inhalation exposures were not assessed. The residential post-application assessment co nsiders non-dietary incidental oral exposures only. Residential post-application exposures are generally co nsidered to be intermittent and short-term in duration.

　　For the residential turf use scenario, post-application incidental oral exposure is assessed for children (1 to < 2 years old as the sentinel population). The turf use site assessed was residential lawn turf as exposures from that use are expected to be higher than any potential exposures from otherturf uses (i.e., recreatio nal parks, golf courses, or treated sod). The assessment was co nducted assuming the maximum application rate (0.47 lbs ai/acre) and used unit exposure values and estimates for area treated or amount handled.

　　Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.

　　4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when co nsidering whether to establish, modify, or revoke a tolerance, the Agency co nsider “available information” co ncerning 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 me tabolite 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 e valuate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

　　D. Safety Factor for Infants and Children

　　1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additio nal 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 databa se on toxicity and exposure unless EPA determines ba sed on reliable data that a different margin of safety will be safe for infants and children. This additio nal margin of safety is commo nly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additio nal safety factor when reliable data available to EPA support the choice of a different factor.

　　2. Prenatal and postnatal sensitivity. There is evidence of increased susceptibility of the young following exposure to sethoxydim in the rat and/or rabbit developmental and reproduction studies. To further assess these effects, the EPA performed a Degree of Co ncern Analysis in which sethoxydim was e valuated for potential developmental effects in the rat and rabbit. Maternal toxicity included transient clinical signs (irregular gait, decreased activity, excessive salivation, and anogenital staining) in rats at 650 mg/kg/day and at the limit dose. Decreased fetal body weight, delayed ossification, and malformations (filamentous tail; lack of tail) were observed in the rat at 650 mg/kg/day and at the limit dose. Maternal toxicity was not observed in rabbits, wheras an increased incidence of incompletely ossified 6th sternebrae was noted in fetuses at the high dose (400 mg/kg/day). Decreased body weight was observed in F 1a, F 1b, and F 2b pups during lactation in the 2-generation reproduction study at 150 mg/kg/day (highest dose tested), while parental toxicity was not observed. The Agency co ncluded from the Degree of Co ncern Analysis that there was low co ncern for pre- and/or post-natal toxicity resulting from exposure to sethoxydim, because the chosen points of departure for risk assessment for each exposure scenario are protective for these effects.

　　3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is ba sed on the following findings:

　　i. The toxicity databa se for sethoxydim is complete.

　　ii. There was no clear evidence of neurotoxicity or neuropathology in the available studies, which include a subchro nic neurotoxicity study. The acute neurotoxicity study and developmental neurotoxicity study requirements have been waived.

　　iii. There is evidence that sethoxydim results in increased susceptibility in in utero exposure to sethoxydim in the rabbit developmental toxicity study and following in utero and/or pre-/post-natal exposure in the 2-generation reproduction study in rats. However, there is low co ncern because the chosen points of departure for risk assessment for each exposure scenario are protective for these effects.

　　iv. There are no residual uncertainties identified in the exposure databa ses. The dietary exposure estimates were partially refined by incorporation of percent of crop treated assumptions; however, tolerance-level residue in food and upper-bound drinking water estimates ba sed on modeling were used which are co nservative assumptions. EPA used similarly co nservative assumptions to assess post-application 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 chro nic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chro nic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are e valuated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

　　1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary co nsumption of food and drinking water. Using the exposure assumptions described in this unit for acute exposure, acute dietary risk estimates for the registered and proposed uses of sethoxydim will occupy 5.4% of the aPAD for the general U.S. population. The risk estimate for the most highly exposed subgroup, children 1-2 year old, was 8.6% of the aPAD.

　　2. Chro nic risk. Using the exposure assumptions described in this unit for chro nic exposure, EPA has co ncluded that chro nic exposure to sethoxydim from food and water will utilize 27% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. ba sed on the explanation in Unit III.C.3., regarding residential use patterns, chro nic 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 chro nic exposure to food and water (co nsidered 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 chro nic exposure through food and water with short-term residential exposures to sethoxydim. The short-term aggregate assessment for children 1-2 years old, the most exposed subpopulation group, includes post-application oral residential exposures from treated turf and chro nic dietary exposure.

　　Using the exposure assumptions described in this unit for short-term exposures, EPA has co ncluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 4,000 that are below the EPA's level of co ncern for sethoxydim.

　　4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chro nic exposure to food and water (co nsidered to be a background exposure level).

　　Because there is no intermediate-term exposure, sethoxydim is not expected to pose an intermediate-term risk.

　　5. Aggregate cancer risk for U.S. population. ba sed on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, sethoxydim is not expected to pose a cancer risk to humans.

　　6. Determination of safety. ba sed on these risk assessments, EPA co ncludes that there is a reaso nable 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

　　An adequate gas chromatography/flame photometric detection GC/FPD method is available (Method I in PAM Vol. II) for determining the combined residues of sethoxydim and its me tabolites co ntaining the 3-alkyl substituted pentanedioic acid moiety in plant and livestock commodities which provides a 0.05 ppm limit of quantitation (LOQ).

　　The method may be requested from: Chief, Analytical Chemistry Branch, Enviro nmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

　　B. Internatio nal Residue Limits

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

　　There are no Codex MRLs established for the residues of sethoxydim in/on raw agricultural or processed commodities.

　　C. Respo nse to Comments

　　One comment was received from a private citizen objecting to establishment of petitioned-for tolerances for residues of sethoxydim and a number of other pesticides on food items as these are “dangerous chemicals” and children are disproportio nately exposed to health risks from their use. In addition, the commenter expressed co ncern a bout the potential for increased cancer rates in children due to pesticide exposures. The Agency understands the commenters' co ncerns regarding chemicals and their potential effects on humans. Pursuant to its authority under the FFDCA, and as discussed further in this preamble, EPA co nducted a comprehensive assessment of sethoxydim, which included an assessment on the carcinogenic potential of sethoxydim. ba sed on its assessment of the available data, EPA has found that there is a reaso nable certainty of no harm to humans, with special emphases on infants and children sensitivity, from aggregate exposure to sethoxydim ba sed on a complete toxicological databa se and the potential exposure levels.

　　D. Revisions to Petitioned-For Tolerances

　　The tolerance for the bushberry subgroup 13-07B is ba sed on the residue data on blueberry, the representative crop at 4.0 ppm and not the previously established tolerances for juneberry, lingonberry, and salal at 5.0 ppm. The juneberry, lingonberry, and salal tolerances were ba sed on the translation of caneberry data, which are no lo nger relevant to these crops following updated crop grouping realignment. Moreover, EPA has determined that available data support a reduction in sethoxydim residue tolerance level for these crops from 5.0 ppm to 4.0 ppm.

　　ba sed on available data and the application of the OECD calculation procedures, EPA is establishing a tolerance of 7.0 ppm for fescue, forage, rather than 6.0 ppm as requested by the petitioner. This difference stems from the co nclusion that o nly 4 independent grass trials were co nducted instead of 5 (as assumed by IR-4).

　　In addition, for the requested rapeseed subgroup 20A and sunflower subgroup 20B crop group conversions, each RAC could potentially be processed into meal. Therefore, following the established meal tolerance of the representative crop, canola meal at 40 ppm for subgroup 20A and sunflower meal at 20 ppm for subgroup 20B, tolerances for the residues of sethoxydim are also required for translation to the following commodities: Calendula, meal at 20 ppm; castor oil plant, meal at 20 ppm; Chinese tallowtree, meal at 20 ppm; cuphea, meal at 40 ppm; echium, meal 40 ppm; euphoriba, meal at 20 ppm; evening primrose, meal at 20 ppm; flax seed, meal at 40 ppm; hare's ear mustard, meal at 40 ppm; jojoba, meal at 20 ppm; lesquerella, meal at 40 ppm; lunaria, meal at 40 ppm; meadowfoam, meal at 40 ppm; milkweed, meal at 40 ppm; mustard, meal at 40 ppm; niger seed, meal at 20 ppm; oil radish, meal at 40 ppm; poppy seed, meal at 40 ppm; rose hip, meal at 20 ppm; sesame, meal at 40 ppm; stokes aster, meal at 20 ppm; sweet rocket, meal at 40 ppm; tallowwood, meal at 20 ppm; tea oil plant, meal at 20 ppm; and vernonia, meal at 20 ppm. Additionally, an existing borage, meal tolerance at 10 ppm is being raised to 40 ppm.

　　Lastly, the Agency is updating the tolerance ex pressions for sethoxydim as follows to reflect current EPA policies: Tolerances are established for the herbicide sethoxydim, including its me tabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring o nly the sum of the herbicide 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-2) and its me tabolites co ntaining the 2-cyclohexen-1-one moiety, calculated as the stoichiometric equivalent of sethoxydim, in or on the commodities listed in the subsections.

　　E. Trade Considerations

　　Establishing a tolerance at 4.0 ppm for the expanded crop subgroup 13-07B results in reductions of the existing sethoxydim tolerance level for juneberry, lingonberry, and salal, which are each set individually at 5.0 ppm. In order to allow a reaso nable interval for producers in the exporting member countries of the World Trade Organization's Sanitary and Phytosanitary Measures Agreement to adapt to the requirements of these modified tolerances, EPA is establishing an expiration date for those higher individual tolerances (for juneberry, lingonberry, and salal) of December 15, 2015. Those tolerances will remain in place for six mo nths after the publication of this rule—and residues of sethoxydim may be present on juneberry, lingonberry, and salal at levels up to 5.0 ppm until theirexpiration date—in order to allow a reaso nable interval for producers in exporting member countries to adapt to the reduced tolerances. After that 6-mo nth period, those individual tolerances will expire, and residues of sethoxydim on juneberry, lingonberry, and salal will need to comply with the bushberry subgroup 13-07B tolerance, which includes those commodities and limits residues to 4.0 ppm.

　　V. Conclusion

　　Tolerances are established for the herbicide sethoxydim, including its me tabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring o nly the sum of the herbicide 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-2) and its me tabolites co ntaining the 2-cyclohexen-1-one moiety, calculated as the stoichiometric equivalent of sethoxydim, in or on commodities: Berry, low growing, subgroup 13-07H, except strawberry at 2.5 ppm; borage, meal at 40 ppm; bushberry, subgroup 13-07B at 4.0 ppm; calendula, meal at 20 ppm; caneberry, subgroup 13-07A at 5.0 ppm; castor oil plant, meal at 20 ppm; Chinese tallowtree, meal at 20 ppm; cottonseed, subgroup 20C at 5.0 ppm; cuphea, meal at 40 ppm; echium, meal 40 ppm; euphorbia, meal at 20 ppm; evening primrose, meal at 20 ppm; fescue, forage at 7.0 ppm; fescue, hay at 4.0 ppm; flax seed, meal at 40 ppm; fruit, citrus, group 10-10 at 0.5 ppm; fruit, pome, group 11-10 at 0.2 ppm; fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit at 1.0 ppm; hare's ear mustard, meal at 40 ppm; jojoba, meal at 20 ppm; lesquerella, meal at 40 ppm; lunaria, meal at 40 ppm; meadowfoam, meal at 40 ppm; milkweed, meal at 40 ppm; mustard, meal at 40 ppm; niger seed, meal at 20 ppm; oil radish, meal at 40 ppm; poppy seed, meal at 40 ppm; rapeseed, subgroup 20A at 35 ppm; rose hip, meal at 20 ppm; sesame, meal at 40 ppm; stokes aster, meal at 20 ppm; sunflower subgroup 20B, except safflower at 7.0 ppm; sweet rocket, meal at 40 ppm; tallowwood, meal at 20 ppm; tea oil plant, meal at 20 ppm; vegetable, bulb, group 3-07 at 1.0 ppm; vegetable, fruiting, group 8-10 to 4.0 ppm; and vernonia, meal at 20 ppm. In addition, upon establishment of the above tolerances, remove the following entries that are superseded by this action including: Blueberry; borage, seed; caneberry subgroup 13A; canola, seed; cotton, undelinted seed; crambe, seed; cranberry; cuphea, seed; echium, seed; flax, seed; fruit, citrus group 10; fruit, pome, group 11; gold of pleasure, seed; grape; hare's ear mustard, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed; milkweed, seed; mustard, seed; oil radish, seed; okra; poppy, seed; rapeseed, seed; sesame, seed; sunflower, seed; sweet rocket, seed; vegetable, bulb group 3; and vegetable, fruiting group 8.

　　Finally, the individual tolerances for juneberry, lingonberry, and salal at 5.0 ppm will expire 6 mo nths from the date of publication of this final rule in the Federal Register.