Carfentrazone-ethyl; Pesticide Tolerance, 9217-9222 [E8-3111]

Download as PDF Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations 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). 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). IX. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to List of Subjects in 40 CFR Part 180 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0193; FRL–8349–4] Carfentrazone-ethyl; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. sroberts on PROD1PC70 with RULES AGENCY: SUMMARY: This regulation establishes a tolerance for residues of carfentrazoneethyl, (ethyl-alpha-2-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzene propanoate) and the metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzenepropanoic acid) in or on barley, bran at 0.80 ppm; barley, flour at 0.80 ppm; grain, aspirated grain fractions at 1.8 ppm; grain, cereal, group 15 (except rice grain and sorghum grain) at 0.10 ppm; grain, cereal, stover at 0.80 ppm; grain, cereal, straw at 3.0 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; hog, meat byproducts at 0.10 ppm; millet, flour at 0.80 ppm; oat, flour at 0.80 ppm; poultry, meat byproducts at 0.10 ppm; rice, grain at 1.3 ppm; rice, Jkt 214001 Authority: 21 U.S.C. 321(q), 346a and 371. 2. In section 180.910 the table is amended by adding alphabetically the following inert ingredients to read as follows: I § 180.910 Inert ingredients used preharvest and post-harvest; exemptions from the requirement of a tolerance. * * * * * Therefore, 40 CFR chapter I is amended as follows: I Limits BILLING CODE 6560–50–S 15:54 Feb 19, 2008 1. The authority citation for part 180 continues to read as follows: I Dated: February 6, 2008. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. * * * d-Alpha tocopherol (CAS Reg. No. 9–02–9 ........................... d-Alpha tocopheryl acetate (CAS Reg. No. 58–95–7) ........... dl-Alpha tocopherol (CAS Reg. No.10191–41–0) ................... dl-Alpha tocopheryl acetate (CAS Reg. No. 7695–91–2) ....... * * * Vitamin E (CAS Reg. No. 1406–18–4) ................................... * * * VerDate Aug<31>2005 PART 180—[AMENDED] Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Inert ingredients [FR Doc. E8–3127 Filed 2–19–08; 8:45 am] 9217 * Uses * Frm 00047 * * * * * Safener Safener Safener Safener * * None Safener * * hulls at 3.5 ppm; rye, bran at 0.80 ppm; rye, flour at 0.80 ppm; sorghum, grain at 0.25 ppm; soybean, seed at 0.10 ppm; sugarcane at 0.15 ppm; wheat, bran at 0.80 ppm; wheat, flour at 0.80 ppm; wheat, germ at 0.80 ppm; wheat, middlings at 0.80 ppm; and wheat, shorts at 0.80 ppm. FMC Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 20, 2008. Objections and requests for hearings must be received on or before April 21, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–0193. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. PO 00000 * None None None None Fmt 4700 Sfmt 4700 Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–6224; e-mail address: miller.joanne@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, E:\FR\FM\20FER1.SGM 20FER1 9218 Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 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 to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. sroberts on PROD1PC70 with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2007–0193 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before April 21, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not VerDate Aug<31>2005 15:54 Feb 19, 2008 Jkt 214001 contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– HQ–OPP–2007–0193 by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Petition for Tolerance In the Federal Register of June 27, 2007 (72 FR 35240) (FRL–8133–4), 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 6F7145) by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103. The petition requested that 40 CFR 180.515 be amended by establishing a tolerance for residues of the herbicide carfentrazoneethyl, (ethyl-alpha-2-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzene propanoate) and the metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzenepropanoic acid) in or on barley, bran at 0.80 ppm; barley, flour at 0.80 ppm; grain, aspirated grain fractions at 1.8 ppm; grain, cereal, group 15 (except rice grain and sorghum grain) at 0.10 ppm; grain, cereal, stover at 0.80 ppm; grain, cereal, straw at 3.0 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; hog, meat byproducts at 0.10 ppm; millet, flour at 0.80 ppm; oat, flour at 0.80 ppm; poultry, meat byproducts at 0.10 ppm; rice, grain at 1.3 ppm; rice, hulls at 3.5 ppm; rye, bran at 0.80 ppm; rye, flour at 0.80 ppm; sorghum, grain at 0.25 ppm; soybean, seed at 0.10 ppm; sugarcane at 0.15 ppm; wheat, bran at 0.80 ppm; wheat, flour at 0.80 ppm; wheat, germ at 0.80 ppm; wheat, PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 middlings at 0.80 ppm; and wheat, shorts at 0.80 ppm. There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996. Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for carfentrzone-ethyl. EPA’s assessment of exposures and risks associated with establishing the petitioned-for tolerances follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Carfentrazoneethyl has low acute oral, dermal, and inhalation toxicity (Toxicity Category 34). It is non-irritating to skin and minimally irritating to eyes. It is not a skin sensitizer. The subchronic toxicity studies in rats, mice, and dogs demonstrated that the primary effects of carfentrazone-ethyl were on hermatology parameters (decreased mean corpuscular hemoglobin: MCH, E:\FR\FM\20FER1.SGM 20FER1 Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations sroberts on PROD1PC70 with RULES mean corpuscular volume: MCV), urinary porphyrin excretion (increased), liver weights (increased), and histopathology. The chronic toxicity studies in rats and dogs demonstrated increased urinary porphyrin and microscopic examination showed hepatoxicity in rats and mice. Fluorescence microscopy on liver sections also revealed red fluorescent granules consistent with porphryin deposits in rats and mice. In carcinogenicity studies in mice and rats, there was no indication of increased incidence of neoplasms and spontaneous tumor formation at the doses tested. The results of the 2– generation reproduction and developmental toxicity studies indicated that carfentrazone-ethyl is not a developmental or reproductive toxicant. The acute and subchronic neurotoxicity studies showed that carfentrazone-ethyl is not neurotoxic. The mutagenic test battery demonstrated that carfentrazone-ethyl is not mutagenic. Specific information on the studies received and the nature of the adverse effects caused by carfentrazone-ethyl as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of August 9, 2000 (65 FR 48621–48623) (FRL–6597– 7). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/ safety factors (UFs) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of VerDate Aug<31>2005 15:54 Feb 19, 2008 Jkt 214001 exposure (MOE) called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/fedrgstr/EPA-PEST/1997/ November/Day-26/p30948.htm. A summary of the toxicological endpoints for carfentrazone-ethyl used for human risk assessment can be found at http://www.regulations.gov in the document titled ‘‘Human Heath Risk Assessment’’ at page 9 in docket ID number EPA–HQ–OPP–2007–0193. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to carfentrazone-ethyl, EPA considered exposure under the petitioned-for tolerances as well as all existing carfentrazone-ethyl tolerances in (40 CFR 180.515). EPA assessed dietary exposures from carfentrazoneethyl in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1–day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994–1996 and 1998 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. iii. Cancer. Carfentrazone-ethyl is classified as ‘‘not likely’’ a human carcinogen and therefore an exposure assessment for assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residues or PCT information in the dietary assessment for carfentrazone-ethyl. The acute and PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 9219 dietary exposure analyses were based on tolerance level residues and 100 PCT assumptions. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for carfentrazone-ethyl in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of carfentrazone-ethyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/ oppefed1/models/water/index.htm. Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCIGROW) models, the estimated environmental concentrations (EECs) of carfentrazone-ethyl for acute exposures are estimated to be 34.3 parts per billion (ppb) for surface water and 13.4 ppb for ground water. The EECs for chronic exposures are estimated to be 19.0 ppb for surface water and 13.4 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 34.3 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 19.0 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Carfentrazone-ethyl is currently registered for the following residential non-dietary sites: Ornamental lawns and turf (application by commercial operators only). Residential exposure is also anticipated from aquatic applications of carfentrazone-ethyl. The risk assessment was conducted using the following residential exposure assumptions: Exposures to toddlers in the residential lawn setting would be higher than that encountered by toddlers in an institutional setting, such as in schools and parks. It was anticipated that herbicide application to homeowner lawns is a seasonal event, thus, only short-term post-application residential exposures were conducted. A swimmer exposure assessment was conducted based on the aquatic E:\FR\FM\20FER1.SGM 20FER1 9220 Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations sroberts on PROD1PC70 with RULES application. The swimmer assessment estimates exposures from oral (ingestion) and inhalation routes. 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 carfentrazone-ethyl and any other substances and carfentrazone-ethyl 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 carfentrazone-ethyl 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 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 (‘‘10X’’) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. There was no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to carfentrazone-ethyl. There is no uncertainty for prenatal and/or postnatal toxicity. 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That VerDate Aug<31>2005 15:54 Feb 19, 2008 Jkt 214001 decision is based on the following findings: i. The toxicity database for carfentrazone-ethyl is complete. ii. There is no indication that carfentrazone-ethyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that carfentrazone-ethyl results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2–generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. Conservative ground and surface water modeling estimates were used. Similarly conservative Residential Standard Operating Procedures were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by carfentrazone-ethyl. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to carfentrazone-ethyl will occupy 1% of the aPAD for the population group (children 1-2 years old) receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to carfentrazone-ethyl from food and water will utilize 89% of the cPAD for the population group (children 1-2 years old) receiving the greatest exposure. Based on the use pattern, chronic residential exposure to residues of carfentrazone-ethyl is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 exposure to food and water (considered to be a background exposure level). Carfentrazone-ethyl is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for carfentrazone-ethyl. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of: General U.S. population = 54,000; infants < 1 year old = 30,000; children 1-2 years old = 18,000; children 3-5 years old = 23,000; children 6-12 years old = 37,000; youth 13-19 years old = 60,000; adults 20-49 yeas old = 69,000; adults >50 years old = 73,000; and females 13-49 years old = 71,000. None of these MOEs show risks of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Residential exposure is not expected to occur over the intermediate-term. Therefore, the aggregate risk is the sum of the risk from food and water. 5. Aggregate cancer risk for U.S. population. Carfentrazone-ethyl is not expected to pose a cancer risk for humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to carfentrazone-ethyl residues. IV. Other Considerations A. Analytical Enforcement Methodology There is a practical method for detecting and measuring levels of carfentrazone-ethyl and its metabolites in or on food with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances. The analytical method involves separate analyses for parent and its metabolite. The parent is analyzed by gas chromatography (GC)/ electron capture detection (ECD). The metabolite is derivatized with boron trifluoride and acetic anhydride for analysis by GC/mass spectrometry detection (MSD) using selective ion monitoring. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone E:\FR\FM\20FER1.SGM 20FER1 Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations number: (410) 305–2905; e-mail address: residuemethods@epa.gov. B. International Residue Limits No Codex maximum residue limits (MRLs) have been established for residues of carfentrazone-ethyl on any crops at this time. sroberts on PROD1PC70 with RULES V. Conclusion Therfore the tolerance is established for residues of carfentrazone-ethyl, (ethyl-alpha-2-dichloro-5-[4(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzene propanoate) and the metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4fluorobenzenepropanoic acid) in or on barley, bran at 0.80 ppm; barley, flour at 0.80 ppm; grain, aspirated grain fractions at 1.8 ppm; grain, cereal, group 15 (except rice grain and sorghum grain) at 0.10 ppm; grain, cereal, stover at 0.80 ppm; grain, cereal, straw at 3.0 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; hog, meat byproducts at 0.10 ppm; millet, flour at 0.80 ppm; oat, flour at 0.80 ppm; poultry, meat byproducts at 0.10 ppm; rice, grain at 1.3 ppm; rice, hulls at 3.5 ppm; rye, bran at 0.80 ppm; rye, flour at 0.80 ppm; sorghum, grain at 0.25 ppm; soybean, seed at 0.10 ppm; sugarcane at 0.15 ppm; wheat, bran at 0.80 ppm; wheat, flour at 0.80 ppm; wheat, germ at 0.80 ppm; wheat, middlings at 0.80 ppm; and wheat, shorts at 0.80 ppm. VI. 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, 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) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to VerDate Aug<31>2005 15:54 Feb 19, 2008 Jkt 214001 Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 9221 List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 6, 2008. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.515 is amending the table in paragraph (a) as follows: a. By placing the entry ‘‘Sorghum, forage’’ before the entry ‘‘Sorghum, sweet.’’ b. By revising the entries for ‘‘Soybean, seed’’ and ‘‘Sugarcane’’, and c. By alphabetically adding the other commodities to read as follows: I § 180.515 Carfentrazone-ethyl; tolerances for residues. (a) * * * Commodity * * Parts per million * * * Barley, bran .................... Barley, flour .................... * * * * * Grain, aspirated grain fractions ....................... * * * * * Grain, cereal, group 15 (except rice grain and sorghum grain) ............ Grain, cereal, stover ....... Grain, cereal, straw ........ * * * 0.80 0.80 1.8 0.10 0.80 3.0 * * Hog, fat ........................... Hog, meat ....................... Hog, meat byproducts .... * * * * Millet, flour ...................... * * * * * Oat, flour ......................... * * * * * Poultry, meat byproducts * * * * * Rice, grain ...................... Rice, hulls ....................... * * * Rye, bran ........................ Rye, flour ........................ E:\FR\FM\20FER1.SGM 20FER1 0.10 0.10 ppm 0.10 * 0.80 0.80 0.10 1.3 3.5 * * 0.80 0.80 9222 Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations 40 CFR Part 180 whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Erik Kraft, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–9358; e-mail address: kraft.erik @epa.gov. SUPPLEMENTARY INFORMATION: [EPA–HQ–OPP–2007–0030; FRL–8349–7] I. General Information Mesotrione; Pesticide Tolerance A. Does this Action Apply to Me? Environmental Protection Agency (EPA). ACTION: Final rule. You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 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 to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. Commodity * * Parts per million * * Sorghum, grain ............... * * * * * Soybean, seed ................ * * * * * Sugarcane ...................... * * * * * Wheat, Wheat, Wheat, Wheat, Wheat, * * 0.25 0.10 0.15 bran .................... flour .................... germ ................... middlings ............ shorts ................. * * * 0.80 0.80 0.80 0.80 0.80 * [FR Doc. E8–3111 Filed 2–19–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY sroberts on PROD1PC70 with RULES AGENCY: SUMMARY: This regulation establishes tolerances for residues of mesotrione in or on asparagus, grass grown for seed, oats, okra, rhubarb, grain sorghum, sweet sorghum, and sugarcane. Syngenta Crop Protection requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 20, 2008. Objections and requests for hearings must be received on or before April 21, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–0030. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information VerDate Aug<31>2005 15:54 Feb 19, 2008 Jkt 214001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2007–0030 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before April 21, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– HQ–OPP–2007–0030, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. E:\FR\FM\20FER1.SGM 20FER1

Agencies

[Federal Register Volume 73, Number 34 (Wednesday, February 20, 2008)]
[Rules and Regulations]
[Pages 9217-9222]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3111]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0193; FRL-8349-4]


Carfentrazone-ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
carfentrazone-ethyl, (ethyl-alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzene 
propanoate) and the metabolite carfentrazone-chloropropionic acid 
(alpha, 2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid) in or on barley, 
bran at 0.80 ppm; barley, flour at 0.80 ppm; grain, aspirated grain 
fractions at 1.8 ppm; grain, cereal, group 15 (except rice grain and 
sorghum grain) at 0.10 ppm; grain, cereal, stover at 0.80 ppm; grain, 
cereal, straw at 3.0 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; 
hog, meat byproducts at 0.10 ppm; millet, flour at 0.80 ppm; oat, flour 
at 0.80 ppm; poultry, meat byproducts at 0.10 ppm; rice, grain at 1.3 
ppm; rice, hulls at 3.5 ppm; rye, bran at 0.80 ppm; rye, flour at 0.80 
ppm; sorghum, grain at 0.25 ppm; soybean, seed at 0.10 ppm; sugarcane 
at 0.15 ppm; wheat, bran at 0.80 ppm; wheat, flour at 0.80 ppm; wheat, 
germ at 0.80 ppm; wheat, middlings at 0.80 ppm; and wheat, shorts at 
0.80 ppm. FMC Corporation requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 20, 2008. Objections and 
requests for hearings must be received on or before April 21, 2008, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0193. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

[[Page 9218]]

nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0193 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before April 21, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0193 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35240) (FRL-8133-
4), 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 
6F7145) by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103. 
The petition requested that 40 CFR 180.515 be amended by establishing a 
tolerance for residues of the herbicide carfentrazone-ethyl, (ethyl-
alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]-4-fluorobenzene propanoate) and the metabolite 
carfentrazone-chloropropionic acid (alpha, 2-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoic acid) in or on barley, bran at 0.80 ppm; barley, 
flour at 0.80 ppm; grain, aspirated grain fractions at 1.8 ppm; grain, 
cereal, group 15 (except rice grain and sorghum grain) at 0.10 ppm; 
grain, cereal, stover at 0.80 ppm; grain, cereal, straw at 3.0 ppm; 
hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; hog, meat byproducts at 
0.10 ppm; millet, flour at 0.80 ppm; oat, flour at 0.80 ppm; poultry, 
meat byproducts at 0.10 ppm; rice, grain at 1.3 ppm; rice, hulls at 3.5 
ppm; rye, bran at 0.80 ppm; rye, flour at 0.80 ppm; sorghum, grain at 
0.25 ppm; soybean, seed at 0.10 ppm; sugarcane at 0.15 ppm; wheat, bran 
at 0.80 ppm; wheat, flour at 0.80 ppm; wheat, germ at 0.80 ppm; wheat, 
middlings at 0.80 ppm; and wheat, shorts at 0.80 ppm. There were no 
comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerance for carfentrzone-ethyl. EPA's assessment of exposures and 
risks associated with establishing the petitioned-for tolerances 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Carfentrazone-ethyl has low acute oral, dermal, and 
inhalation toxicity (Toxicity Category 3-4). It is non-irritating to 
skin and minimally irritating to eyes. It is not a skin sensitizer. The 
subchronic toxicity studies in rats, mice, and dogs demonstrated that 
the primary effects of carfentrazone-ethyl were on hermatology 
parameters (decreased mean corpuscular hemoglobin: MCH,

[[Page 9219]]

mean corpuscular volume: MCV), urinary porphyrin excretion (increased), 
liver weights (increased), and histopathology. The chronic toxicity 
studies in rats and dogs demonstrated increased urinary porphyrin and 
microscopic examination showed hepatoxicity in rats and mice. 
Fluorescence microscopy on liver sections also revealed red fluorescent 
granules consistent with porphryin deposits in rats and mice. In 
carcinogenicity studies in mice and rats, there was no indication of 
increased incidence of neoplasms and spontaneous tumor formation at the 
doses tested. The results of the 2-generation reproduction and 
developmental toxicity studies indicated that carfentrazone-ethyl is 
not a developmental or reproductive toxicant. The acute and subchronic 
neurotoxicity studies showed that carfentrazone-ethyl is not 
neurotoxic. The mutagenic test battery demonstrated that carfentrazone-
ethyl is not mutagenic. Specific information on the studies received 
and the nature of the adverse effects caused by carfentrazone-ethyl as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are 
discussed in the final rule published in the Federal Register of August 
9, 2000 (65 FR 48621-48623) (FRL-6597-7).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for carfentrazone-ethyl 
used for human risk assessment can be found at http://
www.regulations.gov in the document titled ``Human Heath Risk 
Assessment'' at page 9 in docket ID number EPA-HQ-OPP-2007-0193.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to carfentrazone-ethyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing carfentrazone-ethyl 
tolerances in (40 CFR 180.515). EPA assessed dietary exposures from 
carfentrazone-ethyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed all foods for which 
there are tolerances were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for 
which there are tolerances were treated and contain tolerance-level 
residues.
    iii. Cancer. Carfentrazone-ethyl is classified as ``not likely'' a 
human carcinogen and therefore an exposure assessment for assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residues or PCT information in the dietary 
assessment for carfentrazone-ethyl. The acute and dietary exposure 
analyses were based on tolerance level residues and 100 PCT 
assumptions.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for carfentrazone-ethyl in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the environmental 
fate characteristics of carfentrazone-ethyl. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/oppefed1/models/water/
index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of carfentrazone-ethyl 
for acute exposures are estimated to be 34.3 parts per billion (ppb) 
for surface water and 13.4 ppb for ground water. The EECs for chronic 
exposures are estimated to be 19.0 ppb for surface water and 13.4 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 34.3 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 19.0 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Carfentrazone-ethyl is currently registered for the following 
residential non-dietary sites: Ornamental lawns and turf (application 
by commercial operators only). Residential exposure is also anticipated 
from aquatic applications of carfentrazone-ethyl. The risk assessment 
was conducted using the following residential exposure assumptions: 
Exposures to toddlers in the residential lawn setting would be higher 
than that encountered by toddlers in an institutional setting, such as 
in schools and parks. It was anticipated that herbicide application to 
homeowner lawns is a seasonal event, thus, only short-term post-
application residential exposures were conducted. A swimmer exposure 
assessment was conducted based on the aquatic

[[Page 9220]]

application. The swimmer assessment estimates exposures from oral 
(ingestion) and inhalation routes.
    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 carfentrazone-ethyl and 
any other substances and carfentrazone-ethyl 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 
carfentrazone-ethyl 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 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 (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no indication of 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure to carfentrazone-ethyl. There is no uncertainty for 
prenatal and/or postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for carfentrazone-ethyl is complete.
    ii. There is no indication that carfentrazone-ethyl is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that carfentrazone-ethyl results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. Conservative ground and 
surface water modeling estimates were used. Similarly conservative 
Residential Standard Operating Procedures were used to assess post-
application exposure to children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by carfentrazone-ethyl.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to carfentrazone-ethyl will occupy 1% of the aPAD for the population 
group (children 1-2 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
carfentrazone-ethyl from food and water will utilize 89% of the cPAD 
for the population group (children 1-2 years old) receiving the 
greatest exposure. Based on the use pattern, chronic residential 
exposure to residues of carfentrazone-ethyl is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Carfentrazone-ethyl is currently registered for uses that could 
result in short-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and short-
term exposures for carfentrazone-ethyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs of: General U.S. 
population = 54,000; infants < 1 year old = 30,000; children 1-2 years 
old = 18,000; children 3-5 years old = 23,000; children 6-12 years old 
= 37,000; youth 13-19 years old = 60,000; adults 20-49 yeas old = 
69,000; adults >50 years old = 73,000; and females 13-49 years old = 
71,000. None of these MOEs show risks of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Residential 
exposure is not expected to occur over the intermediate-term. 
Therefore, the aggregate risk is the sum of the risk from food and 
water.
    5. Aggregate cancer risk for U.S. population. Carfentrazone-ethyl 
is not expected to pose a cancer risk for humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to carfentrazone-ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There is a practical method for detecting and measuring levels of 
carfentrazone-ethyl and its metabolites in or on food with a limit of 
detection that allows monitoring of food with residues at or above the 
levels set in these tolerances. The analytical method involves separate 
analyses for parent and its metabolite. The parent is analyzed by gas 
chromatography (GC)/electron capture detection (ECD). The metabolite is 
derivatized with boron trifluoride and acetic anhydride for analysis by 
GC/mass spectrometry detection (MSD) using selective ion monitoring. 
The method may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone

[[Page 9221]]

number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    No Codex maximum residue limits (MRLs) have been established for 
residues of carfentrazone-ethyl on any crops at this time.

V. Conclusion

    Therfore the tolerance is established for residues of 
carfentrazone-ethyl, (ethyl-alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzene 
propanoate) and the metabolite carfentrazone-chloropropionic acid 
(alpha, 2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid) in or on barley, 
bran at 0.80 ppm; barley, flour at 0.80 ppm; grain, aspirated grain 
fractions at 1.8 ppm; grain, cereal, group 15 (except rice grain and 
sorghum grain) at 0.10 ppm; grain, cereal, stover at 0.80 ppm; grain, 
cereal, straw at 3.0 ppm; hog, fat at 0.10 ppm; hog, meat at 0.10 ppm; 
hog, meat byproducts at 0.10 ppm; millet, flour at 0.80 ppm; oat, flour 
at 0.80 ppm; poultry, meat byproducts at 0.10 ppm; rice, grain at 1.3 
ppm; rice, hulls at 3.5 ppm; rye, bran at 0.80 ppm; rye, flour at 0.80 
ppm; sorghum, grain at 0.25 ppm; soybean, seed at 0.10 ppm; sugarcane 
at 0.15 ppm; wheat, bran at 0.80 ppm; wheat, flour at 0.80 ppm; wheat, 
germ at 0.80 ppm; wheat, middlings at 0.80 ppm; and wheat, shorts at 
0.80 ppm.

VI. 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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.515 is amending the table in paragraph (a) as follows:
    a. By placing the entry ``Sorghum, forage'' before the entry 
``Sorghum, sweet.''
    b. By revising the entries for ``Soybean, seed'' and ``Sugarcane'', 
and
    c. By alphabetically adding the other commodities to read as 
follows:


Sec.  180.515  Carfentrazone-ethyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Barley, bran.........................................               0.80
Barley, flour........................................               0.80
                                * * * * *
Grain, aspirated grain fractions.....................                1.8
                                * * * * *
Grain, cereal, group 15 (except rice grain and                      0.10
 sorghum grain)......................................
Grain, cereal, stover................................               0.80
Grain, cereal, straw.................................                3.0
                                * * * * *
Hog, fat.............................................               0.10
Hog, meat............................................           0.10 ppm
Hog, meat byproducts.................................               0.10
                                * * * * *
Millet, flour........................................               0.80
                                * * * * *
Oat, flour...........................................               0.80
                                * * * * *
Poultry, meat byproducts.............................               0.10
                                * * * * *
Rice, grain..........................................                1.3
Rice, hulls..........................................                3.5
                                * * * * *
Rye, bran............................................               0.80
Rye, flour...........................................               0.80

[[Page 9222]]

 
                                * * * * *
Sorghum, grain.......................................               0.25
                                * * * * *
Soybean, seed........................................               0.10
                                * * * * *
Sugarcane............................................               0.15
                                * * * * *
Wheat, bran..........................................               0.80
Wheat, flour.........................................               0.80
Wheat, germ..........................................               0.80
Wheat, middlings.....................................               0.80
Wheat, shorts........................................               0.80
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-3111 Filed 2-19-08; 8:45 am]
BILLING CODE 6560-50-S