Pinoxaden; Pesticide Tolerance, 43313-43322 [05-14896]

Download as PDF Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations Inert ingredients Limits Lignosulfonic acid, ammonium salt (CAS Reg. No. 8061–53– 8). Lignosulfonic acid, ammonium sodium salt (CAS Reg. No. 166798–73–8). Lignosulfonic acid, calcium magnesium salt (CAS Reg. No. 55598–86–2). Lignosulfonic acid, calcium salt (CAS Reg. No. 8061–52–7) .. Lignosulfonic acid, calcium sodium salt (CAS Reg. No. 37325–33–0). Lignosulfonic acid, ethoxylated, sodium salt (CAS Reg. No. 68611–14–3). Lignosulfonic acid, magnesium salt (CAS Reg. No. 8061–54– 9). Lignosulfonic acid, potassium salt (CAS Reg. No. 37314–65– 1). Lignosulfonic acid, sodium salt (CAS Reg. No. 8061–51–6) ... Lignosulfonic acid, sodium salt, oxidized (CAS Reg. No. 68855–41–4). Lignosulfonic acid, sodium salt, polymer with formaldehyde and phenol (CAS Reg. No. 37207–89–9). Lignosulfonic acid, sodium salt, sulfomethylated (CAS Reg. No. 68512–34–5). Lignosulfonic acid, zinc salt (CAS Reg. No. 57866–49–6) ...... * * Sulfite liquors and cooking liquors, spent, oxidized (CAS Reg. No. 68514–09–0). * * * * * * * [FR Doc. 05–14887 Filed 7–26–05; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP–2005–0184; FRL–7725–5] Pinoxaden; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes a tolerance for combined residues of pinoxaden in or on barley and wheat. Syngenta Crop Protection, Inc., requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective July 27, 2005. Objections and requests for hearings must be received on or before September 26, 2005. ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under docket identification (ID) number OPP–2005– 0184. All documents in the docket are listed in the EDOCKET index at http:/ /www.epa.gov/edocket/. Although listed in the index, some information is not VerDate jul<14>2003 18:34 Jul 26, 2005 Jkt 205001 43313 Uses ....................... Do. ....................... Do. ....................... Do. ....................... ....................... Do. Do. ....................... Do. ....................... Do. ....................... Do. ....................... ....................... Do. Do. ....................... Do. ....................... Do. ....................... * * ....................... Do. * * * Surfactant, related adjuvants of surfactants * * * * * publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–5697; e-mail address: tompkins.jim@epa.gov. SUPPLEMENTARY INFORMATION: • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides 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. I. General Information B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using EDOCKET (http://www.epa.gov/edocket/), you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http:// 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: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\FR\FM\27JYR1.SGM 27JYR1 43314 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines athttp://www.epa.gpo/ opptsfrs/home/guidelin.htm/. II. Background and Statutory Findings In the Federal Register of November 19, 2004 (69 FR 67731) (FRL–7686–5), 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 4F6817) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419–8300. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for combined residues of the herbicide pinoxaden, 8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate, in or on wheat, grain at 0.70 parts per million (ppm), wheat, forage at 3.0 ppm, wheat, hay at 1.75 ppm, wheat, straw at 1.5 ppm, barley, grain at 0.70 ppm, barley, hay at 1.25 ppm, and barley, straw at 0.60 ppm. That notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing. Based on the Agency’s review the tolerances for pinoxaden are being revised to reflect the CAS chemical name. Additionally, the Agency’s review of the residue chemistry data indicated that the tolerance levels needed to be raised as follows: Wheat, forage to 3.5 ppm; wheat, grain to 1.3 ppm; wheat, hay to 2.0 ppm; barley, grain to 0.9 ppm; barley, hay to 1.5 ppm; and barley, straw to 1.0 ppm. Finally, EPA concluded that tolerances were needed on barley, bran; cattle, fat; cattle, meat; cattle, meat byproducts; egg; milk; poultry, fat; poultry, meat; poultry, meat byproducts; and wheat, bran. The registrant did not propose tolerances for meat, milk, poultry, and egg (MMPE) commodities since feeding studies resulted in residues less than limit of quantitation (LOQ). However, the Agency determined that tolerances are needed on MMPE since the feeding studies were not conducted at ≥ 10X and the livestock metabolism studies indicated that residues are concentrated in some livestock tissues (liver and kidney). The tolerances for pinoxaden will be as follows: 1. The combined residues of the herbicide pinoxaden (8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-diethyl-4-methylphenyl)-tetrahydro-pyrazolo[1,2d][1,4,5]oxadiazepine-7,9-dione (M2), and free and conjugated forms of 8-(2,6diethyl-4-hydroxymethyl-phenyl)tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-7,9-dione (M4), and 4(7,9-dioxo-hexahydro-pyrazolo[1,2-d] [1,4,5]oxadiazepin-8-yl)-3,5-diethylbenzoic acid (M6), calculated as pinoxaden in/on barley, bran at 1.6 ppm; barley, grain at 0.9 ppm; barley, hay at 1.5 ppm; barley, straw at 1.0 ppm; egg at 0.06 ppm; poultry, fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat byproducts at 0.06 ppm; wheat, bran at 3.0 ppm; wheat, forage at 3.5 ppm; wheat, grain at 1.3 ppm; wheat, hay at 2.0 ppm; and wheat, straw at 1.5 ppm. 2. The combined residues of pinoxaden,(8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-diethyl-4-methylphenyl)-tetrahydro-pyrazolo[1,2d][1,4,5]oxadiazepine-7,9-dione (M2), and free and conjugated forms of 8-(2,6diethyl-4-hydroxymethyl-phenyl)tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-7,9-dione (M4), calculated as pinoxaden, in/on cattle, fat at 0.04 ppm; cattle, meat at 0.04 ppm; cattle, meat byproducts at 0.04 ppm; and milk at 0.02 ppm. 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....’’ EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26,1997) (FRL–5754– 7). III. Aggregate Risk Assessment and Determination of Safety Consistent with 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, consistent with section 408(b)(2) of FFDCA. EPA’s assessment of exposures and risks associated with establishing the tolerance 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 nature of the toxic effects caused by pinoxaden are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies reviewed. TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. 870.3100 VerDate jul<14>2003 Study Type Results 90–Day oral toxicity—rat-gavage NOAEL = 300/100 Male/Female (M/F) milligrams/kilogram/day (mg/kg/day) LOAEL = 300 mg/kg/day based on increased water consumption and urinary volume in females. A LOAEL was not observed in males 18:34 Jul 26, 2005 Jkt 205001 PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 E:\FR\FM\27JYR1.SGM 27JYR1 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations 43315 TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued Guideline No. Study Type Results 870.3100 90–Day oral toxicity—rat-diet NOAEL = 466/537 (M/F) mg/kg/day LOAEL = 900/965 (M/F) mg/kg/day based on decreased body weight and body weight gain and increased incidence of renal lesions in both sexes; decreased food consumption and increased water consumption in males; and increased urine volume in females 870.3100 13-Week oral toxicity—mice-gavage NOAEL = 700 mg/kg/day LOAEL = 1,000 mg/kg/day based on increased incidence of piloerection and decreased body weight gain in both sexes, and increased incidence of renal tubular basophilia in males 870.3100 90–Day oral toxicity—mice-diet NOAEL = 365 mg/kg/day in males. NOAEL not observed in females. LOAEL = 708.2/165.9 (M/F) mg/kg/day based on decreased body weight and body weight gain in females, and decreased food efficiency in males 870.3150 90–Day oral rodents NOAEL = 100 mg/kg/day LOAEL = 250 mg/kg/day based on clinical signs of toxicity fluid feces, (vomit, pale and thin appearance, decreased activity, dehydration, cold to touch, and regurgitation in both sexes, and mucus in feces in the males) and decreased body weights, body weight gains, and food consumption in both sexes 870.3200 28–Day dermal toxicity 870.3700 Prenatal developmental icity—rabbit 870.3700 Prenatal developmental—rat Maternal: NOAEL = 30 mg/kg/day LOAEL = 300 mg/kg/day based on decreased body weight gains and food consumption Developmental: NOAEL = 30 mg/kg/day LOAEL = 300 mg/kg/day based on delays in skeletal ossification in the skull and hind digits 870.3800 Reproduction and fertility effects Parental: NOAEL = 250 mg/kg/day LOAEL = 500 mg/kg/day based on increased water consumption, renal tubular atrophy, and chronic nephropathy in both sexes, and increased incidence of renal pelvic dilatation in the males Reproductive: NOAEL = 500 mg/kg/day LOAEL = was not observed Offspring: NOAEL = 250 mg/kg/day LOAEL = 500 mg/kg/day based on decreased body weights and body weight gains in the F1 pups, and decreased body weights in the F2 males 870.4100 Chronic toxicity—dogs NOAEL = 125 mg/kg/day LOAEL = was not observed 870.4200 Carcinogenicity—mice-diet NOAEL = 216.5/181.2 (M/F) mg/kg/day LOAEL = was not observed 870.4200 Carcinogenicity—mice-gavage Study could not be interpreted due to gavage errors and lung involvement. 870.4300 Chronic toxicity/Carcinogenicity—rats-gavage NOAEL = 100 mg/kg/day LOAEL = 250 mg/kg/day based on mortality, clinical signs, and increased serum urea and creatinine in males, and decreased body weights and body weight gains, increased water consumption and incidence of urinalysis findings, kidney surface granulation, and microscopic renal lesions in both sexes 870.5100 In vitro bacterial gene mutation S. typhimurium/E. coli No marked increases in the number of revertants were observed at any concentration in any strain in either trial. [negative] VerDate jul<14>2003 18:34 Jul 26, 2005 toxicity—non- Jkt 205001 NOAEL = 1,000 mg/kg/day (limit dose) LOAEL = was not observed tox- PO 00000 Maternal: NOAEL = 30 mg/kg/day LOAEL = 100 mg/kg/day based on increased mortality, abortion, clinical signs of toxicity, and decreased body weights, body weight gains and food consumption Developmental: NOAEL = 30 mg/kg/day LOAEL = 100 mg/kg/day based on increased incidence of complete early litter resorption Frm 00057 Fmt 4700 Sfmt 4700 E:\FR\FM\27JYR1.SGM 27JYR1 43316 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued Guideline No. Study Type Results 870.5300 In vitro mammalian gene mutation (L5178YTK+/-) No reproducible substantial (≥ 2x solvent controls) and/or concentration-dependent increases in mutant colonies per 106 cells were observed at any dose level in the presence or absence of S9. [negative] 870.5375 In vitro mammalian cytogenetics in V79 Chinese Hamster lung fibroblasts (2001) Although there was not a clear dose-response and several of the increases in percent aberrant cells were within the historical control range (0.0–4.0%), there was sufficient reproducible evidence of a positive mutagenic effect in the presence and absence of S9. [positive] 870.5375 In vitro mammalian cytogenetics in V79 Chinese Hamster lung fibroblasts (2002) There was an increase in the percent aberrant cells that exceeded the historical control range with/without S9 metabolic activation. [positive] 870.5395 In vivo mammalian cytogenetics micronucleus—mice There were no marked increases observed in mean net nuclear grains (NNG) or percent cells in repair (NNG≥ 5) at 2 or 16 hours post-dosing compared to controls. [negative] 870.5550 Unscheduled DNA synthesis (UDS) in mammalian cells (2001) There were no marked increases observed in the mean grains per nucleus or mean NNG in either trial. Negative for increased UDS up to limit dose. [negative] 870.5550 UDS in mammalian cells (2002) There were no marked Increases observed in mean NNG or percent cells in repair (NNG≥5) at 2 or 16 hours post-dosing compared to controls. [negative] 870.6200 Acute neurotoxicity screening battery in rats-gavage NOAEL = 2,000 mg/kg/day LOAEL = was not determined 870.6200 Subchronic neurotoxicity screening battery in rats-gavage NOAEL = 500 mg/kg/day LOAEL = was not determined 870.7485 Metabolism—rat Approximately 90% of the orally gavaged dose was absorbed from the gastrointestinal tract. Approximately, 90% of the absorbed dose was excreted in the urine and feces in 72 hours and excretion was nearly complete in 7 days. Excretion in the urine ranged from 59–78% and in feces 20–25%. Tissue distribution data indicated no significant accumulation in the body. Billiary excretion study did not indicate enterohepatic circulation. No parent compound was detected in the urine, feces or bile. Major metabolite in the urine and feces was the hydrolysis product M2. Major metabolites in the urine were M2 (65%–85%) and M4 (5–13%) and in the feces 50%–70%) and M4 (25%–35%) depending up on the dose. There were no sex related differences in the absorption, distribution, excretion or qualitative profile of the metabolites. 870.7600 In vivo dermal penetration—rat Low dose = 4%, 14%, 18% at 4, 10, 24 hours Mid dose = 1%, 2%, 4% at 4, 10, 24 hours High dose = 17%, 30%, 36% at 4, 10, 24 hours B. Toxicological Endpoints The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. Three other types of safety or UFs may be used: ‘‘Traditional uncertainty VerDate jul<14>2003 18:34 Jul 26, 2005 Jkt 205001 factors;’’ the ‘‘special FQPA safety factor;’’ and the ‘‘default FQPA safety factor.’’ By the term ‘‘traditional uncertainty factor,’’ EPA is referring to those additional UFs used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term ‘‘special FQPA safety factor’’ refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The ‘‘default FQPA safety factor’’ is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor). PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor. For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the E:\FR\FM\27JYR1.SGM 27JYR1 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10-5), one in a million (1 X 10-6), or one in ten million (1 X 10-7). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ‘‘point of departure’’ is identified below which carcinogenic effects are not expected. 43317 The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for pinoxaden used for human risk assessment is shown in Table 2 of this unit: TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PINOXADEN FOR USE IN HUMAN RISK ASSESSMENT Dose used in risk assessment, interspecies and intraspecies and any Traditional UF Special FQPA SF and level of concern for risk assessment Study and toxicological effects Acute dietary (Females 13–49 years of age) NOAEL = 30 mg/kg/day UF = 100 Acute RfD = 0.30 mg/kg/day Special FQPA SF = 1X aPAD = acute RfD/ Special FQPA SF = 0.30 mg/kg/ day Developmental toxicity—rabbit LOAEL = 100 mg/kg/day based on increased incidence of complete early litter resorption. Acute dietary (General population including infants and children) N/A N/A An endpoint of concern attributable to a singledose effect was not identified in the database. Chronic dietary (All populations) NOAEL= 30 mg/kg/day UF = 100 Chronic RfD = 0.30 mg/kg/ day Special FQPA SF = 1X cPAD = chronic RfD/Special FQPA SF = 0.30 mg/ kg/day Developmental toxicity—rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Incidental Oral Short-term (1–30 days) NOAEL = 30 mg/kg/day LOC for MOE = 100 (Residential includes FQPA SF) Developmental toxicity—rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Incidental Oral Intermediate-term (1–6 months) NOAEL = 30 mg/kg/day LOC for MOE = 100 (Residential includes FQPA SF) Developmental toxicity—rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Dermal Short-term (1–30 days) NOAEL = 30 mg/kg/day (Dermal absorption rate = 40%) LOC for MOE = 100 (Residential includes FQPA SF) LOC for MOE (occupational) = 100 Developmental toxicity—rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Dermal Intermediate-term (1– months) NOAEL = 30 mg/kg/day (Dermal absorption rate = 40%) LOC for MOE = 100 (Residential includes FQPA SF) LOC for MOE (occupational) = 100 Developmental toxicity—rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Dermal Long-term (> 6 months) NOAEL = 30 mg/kg/day (Dermal absorption rate = 40%) LOC for MOE = 100 (Residential includes FQPA SF) LOC for MOE (occupational) = 100 Developmental toxicity—rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Exposure scenario VerDate jul<14>2003 18:34 Jul 26, 2005 Jkt 205001 PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 E:\FR\FM\27JYR1.SGM 27JYR1 43318 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PINOXADEN FOR USE IN HUMAN RISK ASSESSMENT—Continued Dose used in risk assessment, interspecies and intraspecies and any Traditional UF Special FQPA SF and level of concern for risk assessment Study and toxicological effects Short-term inhalation (1 to 30 days) NOAEL = 30 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 100 (Residential includes FQPA SF) LOC for MOE (occupational) = 100 Developmental toxicity-rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Intermediate-term inhalation (1–6 months) NOAEL = 30 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 100 (Residential includes FQPA SF) LOC for MOE (occupational)= 100 Developmental toxicity-rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Long-term inhalation (> 6 months) NOAEL = 30 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 100 (Residential includes FQPA SF) LOC for MOE (occupational) = 100 Developmental toxicity—rabbit LOAEL = 100 mg/kg/day based on morbid condition in one rabbit (mortality), clinical signs of toxicity in a morbid rabbit, abortion, decreased body weights, body weight gains, and food consumption. Exposure scenario Cancer (Oral, dermal, inhalation) Not likely to pose a cancer risk. Although an acceptable cancer study in rats was submitted, the dietary cancer study in the mouse was found to be unacceptable due to the failure to test at high enough doses. Nonetheless, based on the following weight-of-evidence, a repeat carcinogenicity study in mice is not required at this time: • No evidence of carcinogenicity was observed in an acceptable/guideline carcinogenicity study in rats. • The gavage carcinogenicity study in mice was conducted at doses as high as 750 mg/kg/day. No tumors were observed in other organs except adenomas/carcinomas in the lungs. However, the interpretation of the adenomas/carcinomas in the lungs was confounded by the gavage errors that may have introduced the dosing solution in to the trachea and lungs, and perhaps leading to lung tumors and excessive mortality. • No tumors were seen in the mouse dietary carcinogenicity study, however, the dosing was considered to be inadequate due to the lack of significant systemic toxicity at doses up to 181.2 mg/kg/day (the study, performed under the Organization for Economic Cooperation and Development (OECD) and EPA guidelines, was terminated early for humanitarian reasons due to excessive decreases in body weight gain in the high-dose animals). • In the 90–day feeding study in mice, pinoxaden was tested up to 7,000 ppm (1,311 mg/kg/day; limit dose), and VerDate jul<14>2003 18:34 Jul 26, 2005 Jkt 205001 did not produce any tumors or severe toxicity. • Pinoxaden was considered to be non-mutagenic. This evidence convinces EPA that repeating the dietary mouse cancer study is unlikely to provide additional useful information for the risk assessment, and that pinoxaden is not likely to pose a cancer risk. C. Exposure Assessment 1. Dietary exposure from food and feed uses. No Tolerances have been established (40 CFR part 180) previously for the combined residues of pinoxaden on any commodities. Risk assessments were conducted by EPA to assess dietary exposures from pinoxaden in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse 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 conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM), which incorporates food consumption data as reported by respondents in the U.S. Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 commodity. The following assumptions were made for the acute exposure assessments: For the acute analyses, tolerance-level residues were assumed for all food commodities with recommended pinoxaden tolerances, and it was assumed that all of the crops included in the analysis were treated. Percent crop treated (PCT) and anticipated residues were not used in the acute risk assessment. ii. Chronic exposure. In conducting the chronic dietary risk assessment EPA used the DEEM-FCIDTM, which incorporates food consumption data as reported by respondents in the USDA 1994 –1996 and 1998 CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: For the chronic analyses, tolerance-level residues were assumed for all food commodities with recommended pinoxaden tolerances, and it was assumed that all of the crops included in the analysis were treated. The PCT and the anticipated residues were not used in the chronic risk assessment. iii. Cancer. Because EPA concluded that pinoxaden is not likely to pose a cancer risk, a cancer exposure assessment was not conducted. 2. Dietary exposure from drinking water. Pinoxaden has never been registered in the United States so drinking water concentration estimates are made by reliance on simulation or E:\FR\FM\27JYR1.SGM 27JYR1 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations modeling taking into account data on the physical characteristics of pinoxaden. The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentration in Ground Water (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/ EXAMS incorporate an index reservoir environment, and both models include a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs), which are the model estimates of a pesticide’s concentration in water. EECs derived from these models are used to quantify drinking water exposure and risk as a %RfD or %PAD. To better evaluate aggregate risk associated with exposure through food and drinking water, OPP is no longer comparing EECs generated by water quality models with Drinking Water Levels of Comparison (DWLOC). Instead, OPP is now directly incorporating the actual water quality model output concentrations into the risk assessment. This method of incorporating water concentrations into our aggregate assessments relies on actual CSFII-reported drinking water consumptions and more appropriately reflects the full distribution of drinking water concentrations. This is further discussed in the aggregate risk section in Unit III.E. Based on the PRZM/EXAMS and SCIGROW models, the EECs of pinoxaden for acute exposures are estimated to be VerDate jul<14>2003 18:34 Jul 26, 2005 Jkt 205001 0.76 parts per billion (ppb) for surface water (90th percentile annual daily maximum) and 0.13 ppb for ground water. The EECs for chronic exposures are estimated to be 0.47 ppb for surface water (90th percentile annual mean) and 0.13 ppb for ground 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). Pinoxaden is not registered for use on any sites that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and‘‘other substances that have a common mechanism of toxicity.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to pinoxaden and any other substances and pinoxaden does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that pinoxaden has 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 the policy statements released by EPA’s OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/pesticides/ cumulative/. D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional ten-fold 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 43319 level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. There are no concerns and no residual uncertainties with regard to pre- and/or postnatal toxicity based on the following reasons: • There is no evidence of qualitative and/or quantitative evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure to pinoxaden. • There is no evidence of increased qualitative and/or quantitative evidence of increased susceptibility to pinoxaden following prenatal exposure in a 2generation reproduction study in rats. • There is no evidence of increased susceptibility to pinoxaden following prenatal exposure in a 2-generation reproduction study in rats. 3. Conclusion. There is a complete toxicity database for pinoxaden and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Additionally, the data show no concerns for pre- or postnatal sensitivity. Accordingly, EPA concludes that it is safe for infants and children to remove the additional 10X FQPA safety factor. E. Aggregate Risks and Determination of Safety For pinoxaden, no residential uses are proposed. Therefore, aggregate risk will consist of exposure from food and drinking water sources. Acute and chronic aggregate risks were calculated. To better evaluate aggregate risk associated with exposure through food and drinking water, OPP is no longer comparing EECs generated by water quality models with DWLOC. Instead, OPP is now directly incorporating the actual water quality model output concentrations into the risk assessment. This method of incorporating water concentrations into our aggregate assessments relies on actual CSFIIreported drinking water consumptions and more appropriately reflects the full distribution of drinking water concentrations. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to pinoxaden will occupy 1.5 % of the aPAD for females 13–49 years old. Drinking water was incorporated directly into the dietary E:\FR\FM\27JYR1.SGM 27JYR1 43320 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations assessment using the annual peak concentration for surface water generated by the PRZM-EXAMS model as a high-end estimate (0.76 ppb; 90th percentile annual daily maximum), and therefore the aggregate exposure for food and water for females 13–49 is 1.5% of the aPAD. An endpoint of concern attributable to a single-dose effect was not identified in the database for the general population, therefore, the only acute risk that pinoxaden poses is as a result of prenatal exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pinoxaden from food will utilize 0.9 % of the cPAD for the U.S. general population, and 2.1 % of the cPAD for children 1–2 years old, the highest exposed population subgroup. Drinking water was incorporated directly into the dietary assessment using the annual mean concentration for surface water generated by the PRZMEXAMS model as a high-end estimate (0.47 ppb; 90th percentile annual mean), and therefore the aggregate exposure for food and water is 0.9% of the cPAD for the general population, and 2.1% of the cPAD for children 1–2 years old. There are no residential uses for pinoxaden that result in chronic residential exposure to pinoxaden. 3. Aggregate cancer risk for U.S. population. As explained in Unit III.B., EPA has concluded that exposure to pinoxaden is not likely to pose a cancer risk. Therefore, an aggregate cancer risk assessment was not conducted. 4. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to residues of pinoxaden and its metabolites. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (117–01) high performance liquid chromatography-mass spectrometry (HPLC-MS/MS) is available to enforce the tolerance expression for the combined residues of pinoxaden and M2 (as M2), and residues of M4 and M6 for plants. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; e-mail address: residuemethods@epa.gov. The proposed enforcement methodology (T001530–03) for livestock is adequate for the determination of two major pinoxaden metabolites, M4 and VerDate jul<14>2003 18:34 Jul 26, 2005 Jkt 205001 M6. Based on its similarities to the plant enforcement method, the Agency expects that the proposed livestock method will be adequate for quantification of pinoxaden and M2. B. International Residue Limits U.S. tolerances for pinoxaden have been harmonized with Canada on the following commodities: Barley, bran at 1.6 ppm; barley, grain at 0.9 ppm; cattle, fat at 0.04 ppm; cattle, meat at 0.04 ppm; cattle, meat byproduct at 0.04 ppm; egg at 0.06 ppm; milk at 0.02 ppm; poultry, fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat byproduct at 0.06 ppm; wheat, bran at 3.0 ppm; and wheat, grain at 1.3 ppm. In addition to the harmonized tolerances, the United States has established tolerances on the following commodities: Barley, hay at 1.5 ppm; barley, straw at 1.0 ppm; wheat, forage at 3.5 ppm; wheat, hay at 2.0 ppm; and wheat, straw at 1.5 ppm. C. Conditions The following are confirmatory data required as conditions of registration: 1. Additional storage stability data for wheat and barley processed fractions. 2. Additional validation data for pinoxaden and M2 residues in livestock commodities (ruminant and poultry). V. Conclusion Therefore, tolerances are established for: 1. The combined residues of pinoxaden (8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-diethyl-4-methylphenyl)-tetrahydro-pyrazolo[1,2d][1,4,5]oxadiazepine-7,9-dione (M2), and free and conjugated forms of 8-(2,6diethyl-4-hydroxymethyl-phenyl)tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-7,9-dione (M4), and 4(7,9-dioxo-hexahydro-pyrazolo[1,2-d] [1,4,5]oxadiazepin-8-yl)-3,5-diethylbenzoic acid (M6), calculated as pinoxaden in/on barley, bran at 1.6 ppm; barley, grain at 0.9 ppm; barley, hay at 1.5 ppm; barley, straw at 1.0 ppm; egg at 0.06 ppm; poultry, fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat byproducts at 0.06 ppm; wheat, bran at 3.0 ppm; wheat, forage at 3.5 ppm; wheat, grain at 1.3 ppm; wheat, hay at 2.0 ppm; and wheat, straw at 1.5 ppm. 2. The combined residues of pinoxaden,(8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-diethyl-4-methyl- PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 phenyl)-tetrahydro-pyrazolo[1,2d][1,4,5]oxadiazepine-7,9-dione (M2), and free and conjugated forms of 8-(2,6diethyl-4-hydroxymethyl-phenyl)tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-7,9-dione (M4), calculated as pinoxaden, in/on cattle, fat at 0.04 ppm; cattle, meat at 0.04 ppm; cattle, meat byproducts at 0.04 ppm; and milk at 0.02 ppm. VI. Objections and Hearing Requests Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of FFDCA provides essentially the same process for persons to‘‘object’’ to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP–2005–0184 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 on or before September 26, 2005. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor’s contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the E:\FR\FM\27JYR1.SGM 27JYR1 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564–6255. 2. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP–2005–0184, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via email to:opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). VerDate jul<14>2003 18:34 Jul 26, 2005 Jkt 205001 VII. Statutory and Executive Order Reviews This final rule establishes a tolerance 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this 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). 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., or 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). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure‘‘meaningful and timely input by State and local officials in the development of regulatory policies that PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 43321 have federalism implications.’’ ‘‘Policies that have federalism implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.’’ This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any ‘‘tribal implications’’ as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.’’ This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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). E:\FR\FM\27JYR1.SGM 27JYR1 43322 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Rules and Regulations oxadiazepine-7,9-dione, calculated as pinoxaden, in/on the following commodities: Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY– Environmental protection, A257, Washington, DC 20554. The Administrative practice and procedure, complete text of this decision may also Agricultural commodities, Pesticides Parts per be purchased from the Commission’s Commodity and pests, Reporting and recordkeeping million duplicating contractor, Best Copy and requirements. Printing, Inc., 445 12th Street, SW., Cattle, fat .................................. 0.04 Dated: July 18, 2005. Cattle, meat .............................. 0.04 Room CY–B402, Washington, DC 20054, James Jones, Cattle, meat byproducts ........... 0.04 telephone 1–800–378–3160 or http:// Milk ........................................... 0.02 www.BCPIWEB.com. The Declaratory Director, Office of Pesticide Programs. Ruling is also available on the FCC’s I Therefore, 40 CFR chapter I is (b) Section 18 emergency exemptions. Web site at http://hraunfoss.fcc.gov/ amended as follows: edocs_public/attachmatch/FCC–05– [Reserved] 123A1.doc or http://hraunfoss.fcc.gov/ (c) Tolerances with regional PART 180—[AMENDED] edocs_public/attachmatch/FCC–05– registrations. [Reserved] 123A1.pdf. The Commission will send a I 1. The authority citation for part 180 (d) Indirect or inadvertent residues. copy of this Declaratory Ruling in a continues to read as follows: [Reserved] report to be sent to Congress and the Authority: 21 U.S.C. 321(q), 346a and 371. [FR Doc. 05–14896 Filed 7–26–05; 8:45 am] Government Accountability Office I 2. Section 180.611 is added to read as BILLING CODE 6560–50–S pursuant to the Congressional Review follows: Act, see 5 U.S.C. 801(a)(1)(A). 1. CSEA establishes a mechanism to § 180.611 Pinoxaden; tolerances for FEDERAL COMMUNICATIONS use spectrum auction proceeds to residues. COMMISSION reimburse Federal agencies operating on (a) General. (1) Tolerances are ‘‘eligible frequencies’’ (the 216–220 established for the combined residues of 47 CFR Part 1 MHz, 1432–1435 MHz, 1710–1755 MHz, pinoxaden (8-(2,6-diethyl-4and 2385–2390 MHz bands, and certain methylphenyl)-1,2,4,5-tetrahydro-7-oxo- [WT Docket No. 05–211; FCC 05–123] other frequency bands) that may be 7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9Implementation of the Commercial reallocated from Federal to non-Federal yl 2,2-dimethylpropanoate), and its Spectrum Enhancement Act use, for the cost of relocating operations. metabolites 8-(2,6-diethyl-4-methylCSEA requires that the ‘‘total cash phenyl)-tetrahydro-pyrazolo[1,2AGENCY: Federal Communications proceeds’’ from any auction of eligible d][1,4,5]oxadiazepine-7,9-dione (M2), Commission. frequencies equal at least 110 percent of and free and conjugated forms of 8-(2,6- ACTION: Declaratory ruling. estimated relocation costs of eligible diethyl-4-hydroxymethyl-phenyl)Federal entities. CSEA prohibits the tetrahydro-pyrazolo[1,2-d][1,4,5] SUMMARY: In order to implement the Commission from concluding any oxadiazepine-7,9-dione (M4), and 4auction revenue requirement in auction of eligible frequencies that falls (7,9-dioxo-hexahydro-pyrazolo[1,2-d] Commercial Spectrum Enhancement short of this revenue requirement. CSEA [1,4,5]oxadiazepin-8-yl)-3,5-diethylAct (CSEA) for any auction of requires the Commission, if it is unable benzoic acid (M6), calculated as frequencies subject to CSEA, the to conclude an auction for this reason, pinoxaden, in/on the following Commission interprets the meaning of to cancel the auction, return any commodities: the term ‘‘total cash proceeds’’ as used deposits from participating bidders held in CSEA to mean winning bids net of in escrow, and absolve such bidders Parts per any applicable bidding credit discounts. from any obligation to bid in any Commodity million subsequent reauction of the spectrum. DATES: Effective August 26, 2005. 2. In order to implement CSEA’s Barley, bran .............................. 1.6 ADDRESSES: Federal Communications Barley, grain ............................. 0.9 revenue requirement, the Commission Commission, 445 Twelfth Street, SW., Barley, hay ................................ 1.5 must determine the meaning of the term Barley, straw ............................. 1.0 Washington, DC 20554. People with ‘‘total cash proceeds’’ as used in the Egg ........................................... 0.06 Disabilities: Contact the FCC to request statute. For the following reasons, the materials in accessible formats (Braille, Poultry, fat ................................ 0.06 Commission interprets ‘‘total cash Poultry, meat ............................ 0.06 large print, electronics files, audio proceeds’’ for purposes of CSEA to Poultry, meat byproducts .......... 0.06 format, etc.) by e-mail at mean winning bids net of any Wheat, bran .............................. 3.0 FCC504@fcc.gov or call the Consumer & applicable bidding credit discounts. Wheat, forage ........................... 3.5 Governmental Affairs Bureau at 202– Under the Commission’s competitive Wheat, grain ............................. 1.3 418–0531 (voice), 202–418–7365 (TTY). bidding rules, winning bids in an Wheat, hay ............................... 2.0 Wheat, straw ............................. 1.5 FOR FURTHER INFORMATION CONTACT: auction do not necessarily translate into Audrey Bashkin or Gary Michaels, amounts actually owed by bidders. The Auctions and Spectrum Access (2) For the combined residues of discrepancy between gross and net Division, Wireless Telecommunications winning bid amounts arises from the pinoxaden, 8-(2,6-diethyl-4methylphenyl)-1,2,4,5-tetrahydro-7-oxo- Bureau, (202) 418–0660. award of bidding credits—i.e., discounts 7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9- SUPPLEMENTARY INFORMATION: This is a on gross winning bids—to eligible yl 2,2-dimethylpropanoate), and its synopsis of the Commission’s designated entities, new entrants into metabolites M2, 8-(2,6-diethyl-4-methyl- Declaratory Ruling in WT Docket No. the broadcast marketplace, and winning phenyl)-tetrahydro-pyrazolo[1,205–211 adopted June 9, 2005, and bidders that undertake to serve d][1,4,5]oxadiazepine-7,9-dione, and released June 14, 2005. The full text of previously underserved tribal lands. In free and conjugated forms of M4, 8-(2,6- this Commission decision is available this context, the plain language of the diethyl-4-hydroxymethyl-phenyl)for inspection and copying during statute appears to refer to an auction’s tetrahydro-pyrazolo[1,2-d][1,4,5] regular business hours at the FCC’s net winning bids rather than gross List of Subjects in 40 CFR Part 180 VerDate jul<14>2003 18:34 Jul 26, 2005 Jkt 205001 PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 E:\FR\FM\27JYR1.SGM 27JYR1

Agencies

[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Rules and Regulations]
[Pages 43313-43322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14896]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0184; FRL-7725-5]


Pinoxaden; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for combined residues 
of pinoxaden in or on barley and wheat. Syngenta Crop Protection, Inc., 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective July 27, 2005. Objections and 
requests for hearings must be received on or before September 26, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0184. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket/. 
Although listed in the index, some information is not publicly 
available, i.e., 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 either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5697; e-mail address: tompkins.jim@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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
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 and Other 
Related Information?

     In addition to using EDOCKET (http://www.epa.gov/edocket/), you 
may access this Federal Register document electronically through the 
EPA Internet under the ``Federal Register'' listings at http://
www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two at http://

[[Page 43314]]

www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines athttp://
www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of November 19, 2004 (69 FR 67731) (FRL-
7686-5), 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 
4F6817) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR part 180 be amended 
by establishing a tolerance for combined residues of the herbicide 
pinoxaden, 8-(2,6-diethyl-4-methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-
pyrazolo[1,2-d][1,4,5] oxadiazepin-9-yl 2,2-dimethylpropanoate, in or 
on wheat, grain at 0.70 parts per million (ppm), wheat, forage at 3.0 
ppm, wheat, hay at 1.75 ppm, wheat, straw at 1.5 ppm, barley, grain at 
0.70 ppm, barley, hay at 1.25 ppm, and barley, straw at 0.60 ppm. That 
notice included a summary of the petition prepared by Syngenta Crop 
Protection, Inc., the registrant. There were no comments received in 
response to the notice of filing.
    Based on the Agency's review the tolerances for pinoxaden are being 
revised to reflect the CAS chemical name. Additionally, the Agency's 
review of the residue chemistry data indicated that the tolerance 
levels needed to be raised as follows: Wheat, forage to 3.5 ppm; wheat, 
grain to 1.3 ppm; wheat, hay to 2.0 ppm; barley, grain to 0.9 ppm; 
barley, hay to 1.5 ppm; and barley, straw to 1.0 ppm. Finally, EPA 
concluded that tolerances were needed on barley, bran; cattle, fat; 
cattle, meat; cattle, meat byproducts; egg; milk; poultry, fat; 
poultry, meat; poultry, meat byproducts; and wheat, bran. The 
registrant did not propose tolerances for meat, milk, poultry, and egg 
(MMPE) commodities since feeding studies resulted in residues less than 
limit of quantitation (LOQ). However, the Agency determined that 
tolerances are needed on MMPE since the feeding studies were not 
conducted at >= 10X and the livestock metabolism studies indicated that 
residues are concentrated in some livestock tissues (liver and kidney). 
The tolerances for pinoxaden will be as follows:
    1. The combined residues of the herbicide pinoxaden (8-(2,6-
diethyl-4-methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-
d][1,4,5] oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites 
8-(2,6-diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-
d][1,4,5]oxadiazepine-7,9-dione (M2), and free and conjugated forms of 
8-(2,6-diethyl-4-hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-
d][1,4,5] oxadiazepine-7,9-dione (M4), and 4-(7,9-dioxo-hexahydro-
pyrazolo[1,2-d] [1,4,5]oxadiazepin-8-yl)-3,5-diethyl-benzoic acid (M6), 
calculated as pinoxaden in/on barley, bran at 1.6 ppm; barley, grain at 
0.9 ppm; barley, hay at 1.5 ppm; barley, straw at 1.0 ppm; egg at 0.06 
ppm; poultry, fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat 
byproducts at 0.06 ppm; wheat, bran at 3.0 ppm; wheat, forage at 3.5 
ppm; wheat, grain at 1.3 ppm; wheat, hay at 2.0 ppm; and wheat, straw 
at 1.5 ppm.
    2. The combined residues of pinoxaden,(8-(2,6-diethyl-4-
methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5] 
oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-
diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5]oxadiazepine-
7,9-dione (M2), and free and conjugated forms of 8-(2,6-diethyl-4-
hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-
7,9-dione (M4), calculated as pinoxaden, in/on cattle, fat at 0.04 ppm; 
cattle, meat at 0.04 ppm; cattle, meat byproducts at 0.04 ppm; and milk 
at 0.02 ppm.
    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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26,1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA.
    EPA's assessment of exposures and risks associated with 
establishing the tolerance 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 nature of the toxic effects caused by pinoxaden are 
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity--rat- NOAEL = 300/100 Male/Female (M/F) milligrams/
                                          gavage                     kilogram/day (mg/kg/day)
                                                                    LOAEL = 300 mg/kg/day based on increased
                                                                     water consumption and urinary volume in
                                                                     females. A LOAEL was not observed in males
----------------------------------------

[[Page 43315]]

 
870.3100                                 90-Day oral toxicity--rat- NOAEL = 466/537 (M/F) mg/kg/day
                                          diet                      LOAEL = 900/965 (M/F) mg/kg/day based on
                                                                     decreased body weight and body weight gain
                                                                     and increased incidence of renal lesions in
                                                                     both sexes; decreased food consumption and
                                                                     increased water consumption in males; and
                                                                     increased urine volume in females
----------------------------------------
870.3100                                 13-Week oral toxicity--    NOAEL = 700 mg/kg/day
                                          mice-gavage                LOAEL = 1,000 mg/kg/day based on increased
                                                                     incidence of piloerection and decreased
                                                                     body weight gain in both sexes, and
                                                                     increased incidence of renal tubular
                                                                     basophilia in males
----------------------------------------
870.3100                                 90-Day oral toxicity--     NOAEL = 365 mg/kg/day in males. NOAEL not
                                          mice-diet                  observed in females.
                                                                    LOAEL = 708.2/165.9 (M/F) mg/kg/day based on
                                                                     decreased body weight and body weight gain
                                                                     in females, and decreased food efficiency
                                                                     in males
----------------------------------------
870.3150                                 90-Day oral toxicity--     NOAEL = 100 mg/kg/day
                                          nonrodents                 LOAEL = 250 mg/kg/day based on clinical
                                                                     signs of toxicity fluid feces, (vomit, pale
                                                                     and thin appearance, decreased activity,
                                                                     dehydration, cold to touch, and
                                                                     regurgitation in both sexes, and mucus in
                                                                     feces in the males) and decreased body
                                                                     weights, body weight gains, and food
                                                                     consumption in both sexes
----------------------------------------
870.3200                                 28-Day dermal toxicity     NOAEL = 1,000 mg/kg/day (limit dose)
                                                                     LOAEL = was not observed
----------------------------------------
870.3700                                 Prenatal developmental     Maternal:
                                          toxicity--rabbit          NOAEL = 30 mg/kg/day
                                                                    LOAEL = 100 mg/kg/day based on increased
                                                                     mortality, abortion, clinical signs of
                                                                     toxicity, and decreased body weights, body
                                                                     weight gains and food consumption
                                                                    Developmental:
                                                                    NOAEL = 30 mg/kg/day
                                                                    LOAEL = 100 mg/kg/day based on increased
                                                                     incidence of complete early litter
                                                                     resorption
----------------------------------------
870.3700                                 Prenatal developmental--   Maternal:
                                          rat                        NOAEL = 30 mg/kg/day
                                                                    LOAEL = 300 mg/kg/day based on decreased
                                                                     body weight gains and food consumption
                                                                     Developmental:
                                                                    NOAEL = 30 mg/kg/day
                                                                    LOAEL = 300 mg/kg/day based on delays in
                                                                     skeletal ossification in the skull and hind
                                                                     digits
----------------------------------------
870.3800                                 Reproduction and           Parental:
                                          fertility effects         NOAEL = 250 mg/kg/day
                                                                    LOAEL = 500 mg/kg/day based on increased
                                                                     water consumption, renal tubular atrophy,
                                                                     and chronic nephropathy in both sexes, and
                                                                     increased incidence of renal pelvic
                                                                     dilatation in the males
                                                                    Reproductive:
                                                                     NOAEL = 500 mg/kg/day
                                                                    LOAEL = was not observed
                                                                    Offspring:
                                                                     NOAEL = 250 mg/kg/day
                                                                    LOAEL = 500 mg/kg/day based on decreased
                                                                     body weights and body weight gains in the
                                                                     F1 pups, and decreased body weights in the
                                                                     F2 males
----------------------------------------
870.4100                                 Chronic toxicity--dogs     NOAEL = 125 mg/kg/day
                                                                     LOAEL = was not observed
----------------------------------------
870.4200                                 Carcinogenicity--mice-     NOAEL = 216.5/181.2 (M/F) mg/kg/day
                                          diet                       LOAEL = was not observed
----------------------------------------
870.4200                                 Carcinogenicity--mice-     Study could not be interpreted due to gavage
                                          gavage                     errors and lung involvement.
----------------------------------------
870.4300                                 Chronic toxicity/          NOAEL = 100 mg/kg/day
                                          Carcinogenicity--rats-    LOAEL = 250 mg/kg/day based on mortality,
                                          gavage                     clinical signs, and increased serum urea
                                                                     and creatinine in males, and decreased body
                                                                     weights and body weight gains, increased
                                                                     water consumption and incidence of
                                                                     urinalysis findings, kidney surface
                                                                     granulation, and microscopic renal lesions
                                                                     in both sexes
----------------------------------------
870.5100                                 In vitro bacterial gene    No marked increases in the number of
                                          mutation S. typhimurium/   revertants were observed at any
                                          E. coli                    concentration in any strain in either
                                                                     trial. [negative]
----------------------------------------

[[Page 43316]]

 
870.5300                                 In vitro mammalian gene    No reproducible substantial (>= 2x solvent
                                          mutation (L5178YTK\+\/-)   controls) and/or concentration-dependent
                                                                     increases in mutant colonies per 10\6\
                                                                     cells were observed at any dose level in
                                                                     the presence or absence of S9. [negative]
----------------------------------------
870.5375                                 In vitro mammalian         Although there was not a clear dose-response
                                          cytogenetics in V79        and several of the increases in percent
                                          Chinese Hamster lung       aberrant cells were within the historical
                                          fibroblasts (2001)         control range (0.0-4.0%), there was
                                                                     sufficient reproducible evidence of a
                                                                     positive mutagenic effect in the presence
                                                                     and absence of S9. [positive]
----------------------------------------
870.5375                                 In vitro mammalian         There was an increase in the percent
                                          cytogenetics in V79        aberrant cells that exceeded the historical
                                          Chinese Hamster lung       control range with/without S9 metabolic
                                          fibroblasts (2002)         activation. [positive]
----------------------------------------
870.5395                                 In vivo mammalian          There were no marked increases observed in
                                          cytogenetics               mean net nuclear grains (NNG) or percent
                                          micronucleus--mice         cells in repair (NNG>= 5) at 2 or 16 hours
                                                                     post-dosing compared to controls.
                                                                     [negative]
----------------------------------------
870.5550                                 Unscheduled DNA synthesis  There were no marked increases observed in
                                          (UDS) in mammalian cells   the mean grains per nucleus or mean NNG in
                                          (2001)                     either trial. Negative for increased UDS up
                                                                     to limit dose. [negative]
----------------------------------------
870.5550                                 UDS in mammalian cells     There were no marked Increases observed in
                                          (2002)                     mean NNG or percent cells in repair
                                                                     (NNG>=5) at 2 or 16 hours post-dosing
                                                                     compared to controls. [negative]
----------------------------------------
870.6200                                 Acute neurotoxicity        NOAEL = 2,000 mg/kg/day
                                          screening battery in      LOAEL = was not determined
                                          rats-gavage
----------------------------------------
870.6200                                 Subchronic neurotoxicity   NOAEL = 500 mg/kg/day
                                          screening battery in       LOAEL = was not determined
                                          rats-gavage
----------------------------------------
870.7485                                 Metabolism--rat            Approximately 90% of the orally gavaged dose
                                                                     was absorbed from the gastrointestinal
                                                                     tract. Approximately, 90% of the absorbed
                                                                     dose was excreted in the urine and feces in
                                                                     72 hours and excretion was nearly complete
                                                                     in 7 days. Excretion in the urine ranged
                                                                     from 59-78% and in feces 20-25%. Tissue
                                                                     distribution data indicated no significant
                                                                     accumulation in the body. Billiary
                                                                     excretion study did not indicate
                                                                     enterohepatic circulation. No parent
                                                                     compound was detected in the urine, feces
                                                                     or bile. Major metabolite in the urine and
                                                                     feces was the hydrolysis product M2. Major
                                                                     metabolites in the urine were M2 (65%-85%)
                                                                     and M4 (5-13%) and in the feces 50%-70%)
                                                                     and M4 (25%-35%) depending up on the dose.
                                                                     There were no sex related differences in
                                                                     the absorption, distribution, excretion or
                                                                     qualitative profile of the metabolites.
----------------------------------------
870.7600                                 In vivo dermal             Low dose = 4%, 14%, 18% at 4, 10, 24 hours
                                          penetration--rat           Mid dose = 1%, 2%, 4% at 4, 10, 24 hours
                                                                     High dose = 17%, 30%, 36% at 4, 10, 24
                                                                     hours
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or UFs may be used: ``Traditional 
uncertainty factors;'' the ``special FQPA safety factor;'' and the 
``default FQPA safety factor.'' By the term ``traditional uncertainty 
factor,'' EPA is referring to those additional UFs used prior to FQPA 
passage to account for database deficiencies. These traditional 
uncertainty factors have been incorporated by the FQPA into the 
additional safety factor for the protection of infants and children. 
The term ``special FQPA safety factor'' refers to those safety factors 
that are deemed necessary for the protection of infants and children 
primarily as a result of the FQPA. The ``default FQPA safety factor'' 
is the additional 10X safety factor that is mandated by the statute 
unless it is decided that there are reliable data to choose a different 
additional factor (potentially a traditional uncertainty factor or a 
special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the

[[Page 43317]]

LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin 
of exposure (MOE) = NOAEL/exposure) is calculated and compared to the 
LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-\5\), one in a million (1 X 10-\6\), or one in 
ten million (1 X 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.
    A summary of the toxicological endpoints for pinoxaden used for 
human risk assessment is shown in Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Pinoxaden for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose used in risk
                                             assessment,          Special FQPA SF and
          Exposure scenario                interspecies and       level of concern for   Study and toxicological
                                         intraspecies and any       risk assessment              effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 30 mg/kg/day     Special FQPA SF = 1X     Developmental toxicity--
(Females 13-49 years of age).........  UF = 100...............  aPAD = acute RfD/         rabbit
                                       Acute RfD = 0.30 mg/kg/   Special FQPA SF = 0.30  LOAEL = 100 mg/kg/day
                                        day.                     mg/kg/day.               based on increased
                                                                                          incidence of complete
                                                                                          early litter
                                                                                          resorption.
--------------------------------------
Acute dietary                          N/A                      N/A                      An endpoint of concern
(General population including infants                                                     attributable to a
 and children).                                                                           single-dose effect was
                                                                                          not identified in the
                                                                                          database.
--------------------------------------
Chronic dietary                        NOAEL= 30 mg/kg/day      Special FQPA SF = 1X     Developmental toxicity--
(All populations)....................  UF = 100...............  cPAD = chronic RfD/       rabbit
                                       Chronic RfD = 0.30 mg/    Special FQPA SF = 0.30  LOAEL = 100 mg/kg/day
                                        kg/day.                  mg/kg/day.               based on morbid
                                                                                          condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------
Incidental Oral                        NOAEL = 30 mg/kg/day     LOC for MOE = 100        Developmental toxicity--
Short-term (1-30 days)...............                            (Residential includes    rabbit
                                                                 FQPA SF)                LOAEL = 100 mg/kg/day
                                                                                          based on morbid
                                                                                          condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------
Incidental Oral                        NOAEL = 30 mg/kg/day     LOC for MOE = 100        Developmental toxicity--
 Intermediate-term (1-6 months)......                            (Residential includes    rabbit
                                                                 FQPA SF)                LOAEL = 100 mg/kg/day
                                                                                          based on morbid
                                                                                          condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------
Dermal                                 NOAEL = 30 mg/kg/day     LOC for MOE = 100        Developmental toxicity--
Short-term (1-30 days)...............  (Dermal absorption rate   (Residential includes    rabbit
                                        = 40%).                  FQPA SF)                LOAEL = 100 mg/kg/day
                                                                LOC for MOE               based on morbid
                                                                 (occupational) = 100.    condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------
Dermal                                 NOAEL = 30 mg/kg/day     LOC for MOE = 100        Developmental toxicity--
Intermediate-term (1- months)........  (Dermal absorption rate   (Residential includes    rabbit
                                        = 40%).                  FQPA SF)                LOAEL = 100 mg/kg/day
                                                                LOC for MOE               based on morbid
                                                                 (occupational) = 100.    condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------
Dermal                                  NOAEL = 30 mg/kg/day    LOC for MOE = 100        Developmental toxicity--
Long-term (> 6 months)...............  (Dermal absorption rate   (Residential includes    rabbit
                                        = 40%).                  FQPA SF)                LOAEL = 100 mg/kg/day
                                                                LOC for MOE               based on morbid
                                                                 (occupational) = 100.    condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------

[[Page 43318]]

 
Short-term inhalation                  NOAEL = 30 mg/kg/day     LOC for MOE = 100        Developmental toxicity-
(1 to 30 days).......................  (inhalation absorption    (Residential includes    rabbit
                                        rate = 100%).            FQPA SF)                LOAEL = 100 mg/kg/day
                                                                LOC for MOE               based on morbid
                                                                 (occupational) = 100.    condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------
Intermediate-term inhalation           NOAEL = 30 mg/kg/day     LOC for MOE = 100        Developmental toxicity-
(1-6 months).........................  (inhalation absorption    (Residential includes    rabbit
                                        rate = 100%).            FQPA SF)                LOAEL = 100 mg/kg/day
                                                                LOC for MOE               based on morbid
                                                                 (occupational)= 100.     condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------
Long-term inhalation                   NOAEL = 30 mg/kg/day      LOC for MOE = 100       Developmental toxicity--
(> 6 months).........................  (inhalation absorption    (Residential includes    rabbit
                                        rate = 100%).            FQPA SF)                LOAEL = 100 mg/kg/day
                                                                LOC for MOE               based on morbid
                                                                 (occupational) = 100.    condition in one
                                                                                          rabbit (mortality),
                                                                                          clinical signs of
                                                                                          toxicity in a morbid
                                                                                          rabbit, abortion,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains, and food
                                                                                          consumption.
--------------------------------------
Cancer                                                     Not likely to pose a cancer risk.
(Oral, dermal, inhalation)...........
----------------------------------------------------------------------------------------------------------------

    Although an acceptable cancer study in rats was submitted, the 
dietary cancer study in the mouse was found to be unacceptable due to 
the failure to test at high enough doses. Nonetheless, based on the 
following weight-of-evidence, a repeat carcinogenicity study in mice is 
not required at this time:
     No evidence of carcinogenicity was observed in an 
acceptable/guideline carcinogenicity study in rats.
     The gavage carcinogenicity study in mice was conducted at 
doses as high as 750 mg/kg/day. No tumors were observed in other organs 
except adenomas/carcinomas in the lungs. However, the interpretation of 
the adenomas/carcinomas in the lungs was confounded by the gavage 
errors that may have introduced the dosing solution in to the trachea 
and lungs, and perhaps leading to lung tumors and excessive mortality.
     No tumors were seen in the mouse dietary carcinogenicity 
study, however, the dosing was considered to be inadequate due to the 
lack of significant systemic toxicity at doses up to 181.2 mg/kg/day 
(the study, performed under the Organization for Economic Cooperation 
and Development (OECD) and EPA guidelines, was terminated early for 
humanitarian reasons due to excessive decreases in body weight gain in 
the high-dose animals).
     In the 90-day feeding study in mice, pinoxaden was tested 
up to 7,000 ppm (1,311 mg/kg/day; limit dose), and did not produce any 
tumors or severe toxicity.
     Pinoxaden was considered to be non-mutagenic.
    This evidence convinces EPA that repeating the dietary mouse cancer 
study is unlikely to provide additional useful information for the risk 
assessment, and that pinoxaden is not likely to pose a cancer risk.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No Tolerances have 
been established (40 CFR part 180) previously for the combined residues 
of pinoxaden on any commodities. Risk assessments were conducted by EPA 
to assess dietary exposures from pinoxaden in food as follows:
    i. Acute exposure. Acute dietary 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 conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\TM\), which incorporates food consumption 
data as reported by respondents in the U.S. Department of Agriculture 
(USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake 
by Individuals (CSFII), and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the acute 
exposure assessments: For the acute analyses, tolerance-level residues 
were assumed for all food commodities with recommended pinoxaden 
tolerances, and it was assumed that all of the crops included in the 
analysis were treated. Percent crop treated (PCT) and anticipated 
residues were not used in the acute risk assessment.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994 -1996 and 
1998 CSFII, and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: For the chronic analyses, tolerance-level residues were 
assumed for all food commodities with recommended pinoxaden tolerances, 
and it was assumed that all of the crops included in the analysis were 
treated. The PCT and the anticipated residues were not used in the 
chronic risk assessment.
    iii. Cancer. Because EPA concluded that pinoxaden is not likely to 
pose a cancer risk, a cancer exposure assessment was not conducted.
    2. Dietary exposure from drinking water. Pinoxaden has never been 
registered in the United States so drinking water concentration 
estimates are made by reliance on simulation or

[[Page 43319]]

modeling taking into account data on the physical characteristics of 
pinoxaden.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The Screening Concentration in Ground Water (SCI-GROW) model 
is used to predict pesticide concentrations in shallow ground water. 
For a screening-level assessment for surface water EPA will use FIRST 
(a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST 
model is a subset of the PRZM/EXAMS model that uses a specific high-end 
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate 
an index reservoir environment, and both models include a percent crop 
area factor as an adjustment to account for the maximum percent crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD.
    To better evaluate aggregate risk associated with exposure through 
food and drinking water, OPP is no longer comparing EECs generated by 
water quality models with Drinking Water Levels of Comparison (DWLOC). 
Instead, OPP is now directly incorporating the actual water quality 
model output concentrations into the risk assessment. This method of 
incorporating water concentrations into our aggregate assessments 
relies on actual CSFII-reported drinking water consumptions and more 
appropriately reflects the full distribution of drinking water 
concentrations. This is further discussed in the aggregate risk section 
in Unit III.E.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of pinoxaden 
for acute exposures are estimated to be 0.76 parts per billion (ppb) 
for surface water (90\th\ percentile annual daily maximum) and 0.13 ppb 
for ground water. The EECs for chronic exposures are estimated to be 
0.47 ppb for surface water (90th percentile annual mean) and 0.13 ppb 
for ground 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). Pinoxaden is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and`` other substances 
that have a common mechanism of toxicity.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to pinoxaden and any other substances and pinoxaden does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has not assumed 
that pinoxaden has 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 the policy statements 
released by EPA's OPP concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/
cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional ten-fold 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. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There are no concerns and no 
residual uncertainties with regard to pre- and/or postnatal toxicity 
based on the following reasons:
     There is no evidence of qualitative and/or quantitative 
evidence of increased susceptibility of rat and rabbit fetuses to in 
utero exposure to pinoxaden.
     There is no evidence of increased qualitative and/or 
quantitative evidence of increased susceptibility to pinoxaden 
following prenatal exposure in a 2-generation reproduction study in 
rats.
     There is no evidence of increased susceptibility to 
pinoxaden following prenatal exposure in a 2-generation reproduction 
study in rats.
    3. Conclusion. There is a complete toxicity database for pinoxaden 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. Additionally, the data 
show no concerns for pre- or postnatal sensitivity. Accordingly, EPA 
concludes that it is safe for infants and children to remove the 
additional 10X FQPA safety factor.

E. Aggregate Risks and Determination of Safety

    For pinoxaden, no residential uses are proposed. Therefore, 
aggregate risk will consist of exposure from food and drinking water 
sources. Acute and chronic aggregate risks were calculated.
    To better evaluate aggregate risk associated with exposure through 
food and drinking water, OPP is no longer comparing EECs generated by 
water quality models with DWLOC. Instead, OPP is now directly 
incorporating the actual water quality model output concentrations into 
the risk assessment. This method of incorporating water concentrations 
into our aggregate assessments relies on actual CSFII-reported drinking 
water consumptions and more appropriately reflects the full 
distribution of drinking water concentrations.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
pinoxaden will occupy 1.5 % of the aPAD for females 13-49 years old. 
Drinking water was incorporated directly into the dietary

[[Page 43320]]

assessment using the annual peak concentration for surface water 
generated by the PRZM-EXAMS model as a high-end estimate (0.76 ppb; 
90\th\ percentile annual daily maximum), and therefore the aggregate 
exposure for food and water for females 13-49 is 1.5% of the aPAD.
    An endpoint of concern attributable to a single-dose effect was not 
identified in the database for the general population, therefore, the 
only acute risk that pinoxaden poses is as a result of prenatal 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to pinoxaden 
from food will utilize 0.9 % of the cPAD for the U.S. general 
population, and 2.1 % of the cPAD for children 1-2 years old, the 
highest exposed population subgroup. Drinking water was incorporated 
directly into the dietary assessment using the annual mean 
concentration for surface water generated by the PRZM-EXAMS model as a 
high-end estimate (0.47 ppb; 90\th\ percentile annual mean), and 
therefore the aggregate exposure for food and water is 0.9% of the cPAD 
for the general population, and 2.1% of the cPAD for children 1-2 years 
old. There are no residential uses for pinoxaden that result in chronic 
residential exposure to pinoxaden.
    3. Aggregate cancer risk for U.S. population. As explained in Unit 
III.B., EPA has concluded that exposure to pinoxaden is not likely to 
pose a cancer risk. Therefore, an aggregate cancer risk assessment was 
not conducted.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to residues of pinoxaden and its metabolites.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (117-01) high performance liquid 
chromatography-mass spectrometry (HPLC-MS/MS) is available to enforce 
the tolerance expression for the combined residues of pinoxaden and M2 
(as M2), and residues of M4 and M6 for plants. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
    The proposed enforcement methodology (T001530-03) for livestock is 
adequate for the determination of two major pinoxaden metabolites, M4 
and M6. Based on its similarities to the plant enforcement method, the 
Agency expects that the proposed livestock method will be adequate for 
quantification of pinoxaden and M2.

B. International Residue Limits

    U.S. tolerances for pinoxaden have been harmonized with Canada on 
the following commodities: Barley, bran at 1.6 ppm; barley, grain at 
0.9 ppm; cattle, fat at 0.04 ppm; cattle, meat at 0.04 ppm; cattle, 
meat byproduct at 0.04 ppm; egg at 0.06 ppm; milk at 0.02 ppm; poultry, 
fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat byproduct at 
0.06 ppm; wheat, bran at 3.0 ppm; and wheat, grain at 1.3 ppm.
    In addition to the harmonized tolerances, the United States has 
established tolerances on the following commodities: Barley, hay at 1.5 
ppm; barley, straw at 1.0 ppm; wheat, forage at 3.5 ppm; wheat, hay at 
2.0 ppm; and wheat, straw at 1.5 ppm.

C. Conditions

    The following are confirmatory data required as conditions of 
registration:
    1. Additional storage stability data for wheat and barley processed 
fractions.
    2. Additional validation data for pinoxaden and M2 residues in 
livestock commodities (ruminant and poultry).

V. Conclusion

    Therefore, tolerances are established for:
    1. The combined residues of pinoxaden (8-(2,6-diethyl-4-
methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5] 
oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-
diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5]oxadiazepine-
7,9-dione (M2), and free and conjugated forms of 8-(2,6-diethyl-4-
hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-
7,9-dione (M4), and 4-(7,9-dioxo-hexahydro-pyrazolo[1,2-d] 
[1,4,5]oxadiazepin-8-yl)-3,5-diethyl-benzoic acid (M6), calculated as 
pinoxaden in/on barley, bran at 1.6 ppm; barley, grain at 0.9 ppm; 
barley, hay at 1.5 ppm; barley, straw at 1.0 ppm; egg at 0.06 ppm; 
poultry, fat at 0.06 ppm; poultry, meat at 0.06 ppm; poultry, meat 
byproducts at 0.06 ppm; wheat, bran at 3.0 ppm; wheat, forage at 3.5 
ppm; wheat, grain at 1.3 ppm; wheat, hay at 2.0 ppm; and wheat, straw 
at 1.5 ppm.
    2. The combined residues of pinoxaden,(8-(2,6-diethyl-4-
methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5] 
oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites 8-(2,6-
diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5]oxadiazepine-
7,9-dione (M2), and free and conjugated forms of 8-(2,6-diethyl-4-
hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-
7,9-dione (M4), calculated as pinoxaden, in/on cattle, fat at 0.04 ppm; 
cattle, meat at 0.04 ppm; cattle, meat byproducts at 0.04 ppm; and milk 
at 0.02 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to``object'' 
to a regulation for an exemption from the requirement of a tolerance 
issued by EPA under new section 408(d) of FFDCA, as was provided in the 
old sections 408 and 409 of FFDCA. However, the period for filing 
objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0184 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 on or before September 
26, 2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information