Flucarbazone-sodium; Pesticide Tolerance, 76927-76932 [E6-21843]

Download as PDF Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations (1) You commenced its construction after December 24, 2002; and (2) The construction is of a completely new automobile and lightduty truck assembly plant, automobile and light-duty truck paint shop, automobile and light-duty truck topcoat operation, other motor vehicle assembly plant, other motor vehicle paint shop, or other motor vehicle topcoat operation where previously no automobile and light-duty truck assembly plant, automobile and light-duty truck assembly paint shop, or automobile and light-duty truck assembly topcoat operation had existed; and (i) No other motor vehicle assembly plant, other motor vehicle paint shop, or other motor vehicle topcoat operation had existed previously; or (ii) No previously existing other motor vehicle assembly plant, other motor vehicle paint shop, or other motor vehicle topcoat operation is subject to this subpart; or (iii) If the facility was previously not a major source for HAP, no previously existing other motor vehicle assembly plant, other motor vehicle paint shop, or other motor vehicle topcoat operation is made part of the affected source under this subpart. * * * * * 5. Section 63.3110 is amended by revising paragraph (b) to read as follows: I § 63.3110 submit? What notifications must I jlentini on PROD1PC65 with RULES * 17:32 Dec 21, 2006 Jkt 211001 § 63.3176 subpart? What definitions apply to this * * * * * Automobile and light-duty truck assembly plant means a facility which assembles automobiles or light-duty trucks, including coating facilities and processes. * * * * * Other motor vehicle means a selfpropelled vehicle designed for transporting persons or property on a street or highway that has a gross vehicle weight rating over 8,500 pounds. You may choose to make the coating of other motor vehicles subject to this subpart pursuant to § 63.3082(c). Other motor vehicle assembly plant means a facility which assembles other motor vehicles, including coating facilities and processes. * * * * * Subpart MMMM—[Amended] * * * * (b) You must submit the Initial Notification required by § 63.9(b) for a new or reconstructed affected source no later than 120 days after initial startup or 120 days after June 25, 2004, whichever is later. For an existing affected source, you must submit the Initial Notification no later than 1 year after April 26, 2004. Existing sources that have previously submitted notifications of applicability of this rule pursuant to § 112(j) of the CAA are not required to submit an Initial Notification under § 63.9(b) except to identify and describe all additions to the affected source made pursuant to § 63.3082(c). If you elect to include the surface coating of new other motor vehicle bodies, body parts for new other motor vehicles, parts for new other motor vehicles, or aftermarket repair or replacement parts for other motor vehicles in your affected source pursuant to § 63.3082(c) and your affected source has an initial startup before February 20, 2007, then you must submit an Initial Notification of this election no later than 120 days after VerDate Aug<31>2005 initial startup or February 20, 2007, whichever is later. * * * * * I 6. Section 63.3176 is amended by: I a. Removing the definition of ‘‘Automobile and/or light-duty truck assembly plant’’. I b. Adding in alphabetical order definitions for ‘‘Automobile and lightduty truck assembly plant,’’ ‘‘Other motor vehicle,’’ and ‘‘Other motor vehicle assembly plant’’ to read as follows: 7. Section 63.3881 is amended by revising the last sentence of paragraph (d) to read as follows: I § 63.3881 Am I subject to this subpart? * * * * * (d) * * * Surface coating operations on metal parts or products (e.g., parts for motorcycles or lawnmowers) not intended for use in automobiles, lightduty trucks, or other motor vehicles as defined in § 63.3176 cannot be made part of your affected source under subpart IIII of this part. * * * * * Subpart PPPP—[Amended] 8. Section 63.4481 is amended by revising the last sentence of paragraph (d) to read as follows: I § 63.4481 Am I subject to this subpart? * * * * * (d) * * * Surface coating operations on plastic parts or products (e.g., parts for motorcycles or lawnmowers) not intended for use in automobiles, lightduty trucks, or other motor vehicles as defined in § 63.3176 cannot be made PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 76927 part of your affected source under subpart IIII of this part. * * * * * [FR Doc. E6–21975 Filed 12–21–06; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–0935; FRL–8105–6] Flucarbazone–sodium; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes a tolerance for combined residues of flucarbazone-sodium, 4,5-dihydro-3methoxy-4-methyl-5-oxo-N[[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, sodium salt and its N-desmethyl metabolite in or on wheat, forage at 0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone–sodium and its metabolites converted to 2(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep at 1.5 ppm. Arysta LifeScience North America Corporation, 15401 Weston Parkway, Suite 150, Cary, NC 27513 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 December 22, 2006. Objections and requests for hearings must be received on or before February 20, 2007, 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–2006–0935. All documents in the docket are listed in the index for the docket. 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 E:\FR\FM\22DER1.SGM 22DER1 76928 Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations 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 Building), 2777 S. Crystal Drive, Arlington, VA. The 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 (7505P), 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 jlentini on PROD1PC65 with RULES 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? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access VerDate Aug<31>2005 17:32 Dec 21, 2006 Jkt 211001 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 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 the FFDCA, as amended by the 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. 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–2006–0935. 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 February 20, 2007. 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 your copies, identified by docket ID number EPA–HQ–OPP–2006–0935, 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 Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305– 5805. II. Background and Statutory Findings In the Federal Register of October 20, 2006 (70 FR 61969) (FRL–8099–1), EPA PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 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 6F7112) by Arysta LifeScience North America Corporation, 15401 Weston Parkway, Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.562 be amended by establishing a tolerance for combined residues of flucarbazone-sodium, 4,5dihydro-3-methoxy-4-methyl-5-oxo-N[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, sodium salt and its N-desmethyl metabolite in or on wheat, forage at 0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its metabolites converted to 2(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep at 1.5 ppm. That notice included a summary of the petition prepared by Arysta LifeScience North America Corporation, the registrant. There were no comments received in response to the notice of filing. 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 the FFDCA and a complete description of the risk assessment process, see http:// www.epa.gov/fedrgstr/EPA-PEST/1997/ November/Day-26/p30948.htm. E:\FR\FM\22DER1.SGM 22DER1 Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations 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, for a tolerance for combined residues of flucarbazone-sodium, 4,5dihydro-3-methoxy-4-methyl-5-oxo-N[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, sodium salt and its N-desmethyl metabolite in or on wheat, forage at 0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its metabolites converted to 2(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep at 1.5 ppm. 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. Specific information on the studies received and the nature of the toxic effects caused by flucarbazone-sodium as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found at http://docket.epa.gov/ edkpub/index.jsp. jlentini on PROD1PC65 with RULES B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, 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 VerDate Aug<31>2005 17:32 Dec 21, 2006 Jkt 211001 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. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify nonthreshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http:// docket.epa.govedkpub/index.jsp. A summary of the toxicological endpoints for flucarbazone-sodium used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364) (FRL–6745–9). C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.562) for the combined residues of flucarbazonesodium, 4,5-dihydro-3-methoxy-4methyl-5-oxo-N[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, sodium salt and its N-desmethyl metabolite in or on wheat, forage at 0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its metabolites converted to 2(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep at 1.5 ppm. Risk assessments were conducted by EPA to assess dietary exposures from flucarbazone-sodium 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. The Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989–1992 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: A summary of the acute dietary exposure PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 76929 assessment is discussed in Unit III.C of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). ii. Chronic exposure. In conducting this chronic dietary risk assessment the (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989–1992 Nationwide (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A summary of the chronic dietary exposure assessment is discussed in Unit III.C. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). iii. Cancer. A summary of the dietary exposure assessment is discussed in Unit III.C. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data CallIns for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for flucarbazone-sodium 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 physical characteristics of flucarabazone-sodium. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://docket.epa.gov/edkpub/index.jsp. Based on the Generic Expected Environmental Concentration (GENEEC) E:\FR\FM\22DER1.SGM 22DER1 76930 Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations jlentini on PROD1PC65 with RULES and Screening Concentrations in Groundwater (SCI-GROW) models, the estimated environmental concentrations (EECs) of flucarbazone-sodium for acute exposures are estimated to be 1.42 parts per billion (ppb) for surface water and 0.2 ppb for ground water. The EECs for chronic exposures are estimated to be 1.25 ppb for surface water and 0.2 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). Flucarbazone-sodium 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 flucarbazone-sodium and any other substances and flucarbazone-sodium 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 flucarbazone-sodium 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 Office of Pesticide Programs 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 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 data base on toxicity and exposure unless EPA determines based on reliable data that a VerDate Aug<31>2005 17:32 Dec 21, 2006 Jkt 211001 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 Margin of exposure 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. A summary of the prenatal and postnatal sensitivity assessment is discussed in the Federal Register of September 29, 2000 (65 FR 58364). 3. Conclusion. There is a complete toxicity data base for flucarbazonesodium and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. A summary of the safety factor is discussed in Unit III.D. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). E. Aggregate Risks and Determination of Safety 1. Acute risk. A summary of the acute risk assessment is discussed in Unit III.E. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). 2. Chronic risk. A summary of the chronic risk assessment is discussed in Unit III.E. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). 3. Short-term risk. A summary of the short-term risk assessment is discussed in Unit III.E. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). 4. Intermediate-term risk. A summary of the intermediate-term risk assessment is discussed in Unit III.E. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). 5. Aggregate cancer risk for U.S. population. A summary of the aggregate cancer risk for U.S. population assessment is discussed in Unit III.E. of the final rule published in the Federal Register of September 29, 2000 (65 FR 58364). 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, and to infants and children from aggregate exposure to flucarbazone-sodium residues. PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 IV. Other Considerations A. Analytical Enforcement Methodology The petitioner has proposed residue analytical methods for tolerance enforcement in wheat and livestock commodities. The analytical enforcement method for wheat employs accelerated solvent extraction, clean-up using solid phase extraction columns followed by detection and quantitation by liquid chromatography/tandem mass spectroscopy (LC/MS/MS). The analytical method for livestock commodities is a common moiety method which measures residues of flucarbazone-sodium (MKH 6562) in animal tissues and milk by extracting and hydrolyzing MKH 6562 and MKH 6562-related residues to MKH 6562 sulfonamide. Detection is achieved using negative ion electrospray mass spectrometry using deuterated MKH 6562 sulfonamide as an internal standard. Both methods have undergone successful validations by independent laboratories and have been accepted by the Agency. The analytical standards for these methods are available from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@epa.gov. B. International Residue Limits A default Maximum Residue Limit (MRL) of 0.01 ppm has been established in Canada for residues of flucarbazonesodium and its N-desmethyl metabolite on wheat grain. This value is consistent with the tolerance being established in the United States on wheat grain. There are no Codex MRLs for this compound on wheat. Therefore, no compatibility issues exist with Codex in regard to the U.S. tolerances discussed in this review. V. Conclusion Therefore, the tolerance is established for combined residues of flucarbazonesodium, 4,5-dihydro-3-methoxy-4methyl-5-oxo-N[2(trifluoromethoxy)phenyl] sulfonyl1H-1,2,4-triazole 1-carboxamide, sodium salt and its N-desmethyl metabolite in or on wheat, forage at 0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its metabolites converted to 2(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep at 1.5 ppm. E:\FR\FM\22DER1.SGM 22DER1 jlentini on PROD1PC65 with RULES Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations 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 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. The Agency hereby certifies that this rule will not have significant negative economic impact on a substantial number of small entities. 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 VerDate Aug<31>2005 17:32 Dec 21, 2006 Jkt 211001 EPA to develop an accountable process to ensure ‘‘meaningful and timely input by State and local officials in the development of regulatory policies that 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. VII. 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 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 76931 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: December 14, 2006. 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 180.562, paragraph (a) is revised to read as follows: I §180.562 Flucarbazone-sodium; tolerances for residues. (a) General. Tolerances are established for combined residues of the herbicide flucarbazone-sodium, 4,5dihydro-3-methoxy-4-methyl-5-oxo-N[[2(trifluoromethoxy)phenyl] sulfonyl]1H-1,2,4-triazole 1-carboxamide, sodium salt) and its N-desmethyl metabolite; and its metabolites converted to 2(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-sodium in or on the following food commodities: Commodity Cattle, liver ................................ Cattle, meat .............................. Cattle, meat byproducts except liver ........................................ Goat, liver ................................. Goat, meat ................................ Goat, meat byproducts except liver ........................................ Hog, liver .................................. Hog, meat ................................. Hog, meat byproducts except liver ........................................ Horse, liver ............................... Horse, meat .............................. Horse, meat by-products except liver ................................ Milk ........................................... Sheep, liver ............................... Sheep, meat ............................. Sheep, meat byproducts except liver ........................................ Wheat, forage ........................... Wheat, grain ............................. Wheat, hay ............................... Wheat, straw ............................. E:\FR\FM\22DER1.SGM 22DER1 Parts per million 1.50 0.01 0.01 1.50 0.01 0.01 1.50 0.01 0.01 1.50 0.01 0.01 0.005 1.50 0.01 0.01 0.30 0.01 0.10 0.05 76932 * * Federal Register / Vol. 71, No. 246 / Friday, December 22, 2006 / Rules and Regulations * * * [FR Doc. E6–21843 Filed 12–21–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 372 [TRI–2005–0073; FRL–8260–4] RIN 2025–AA14 Toxics Release Inventory Burden Reduction Final Rule Environmental Protection Agency (EPA). ACTION: Final rule. jlentini on PROD1PC65 with RULES AGENCY: SUMMARY: EPA is revising the Toxics Release Inventory (TRI) reporting requirements to reduce burden while continuing to provide valuable information to the public, and promote recycling and treatment as alternatives to disposal and other releases. TRI reporting is required by section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and section 6607 of the Pollution Prevention Act (PPA). This rule expands non-Persistent Bioaccumulative and Toxic (non-PBT) chemical eligibility for Form A by raising the eligibility threshold to 5,000 pounds of total annual waste management (i.e., releases, recycling, energy recovery, and treatment for destruction) provided total annual releases of the non-PBT chemical comprise no more than 2,000 pounds of the 5,000-pound total waste management limit. This rule also allows, for the first time, limited use of Form A for PBT chemicals when total annual releases of a PBT chemical are zero and the total annual amount of the PBT chemical recycled, combusted for energy, and treated for destruction does not exceed 500 pounds. This rule, however, retains the current exclusion of dioxin and dioxin-like compounds from Form A eligibility. By structuring Form A eligibility for both PBT chemicals and non-PBT chemicals in a way that favors recycling and treatment over disposal and other releases, today’s rule encourages facilities to reduce their releases and ensures that valuable information will continue to be provided to the public pursuant to the purposes of section 313 of EPCRA and section 6607 of PPA. Further, to guard against situations where large nonproduction related amounts are not reported on Form R and to provide greater consistency between PBT chemical and non-PBT chemical Form A eligibility, this rule redefines the non- VerDate Aug<31>2005 17:32 Dec 21, 2006 Jkt 211001 PBT Form A eligibility threshold to include non-production related amounts reported in Section 8.8 of Form R. DATES: This rule is effective on January 22, 2007. The first reports with the revised reporting requirements will be due on or before July 1, 2007, for reporting year (i.e., calendar year) 2006. ADDRESSES: EPA has established a docket for this action under Docket ID No. TRI–2005–0073. All documents in the docket are listed in the docket index at http://www.regulations.gov. Although listed in the index, some information is not publicly available, i.e., confidential business information (CBI) or other information, the disclosure of which 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 at www.regulations.gov or in hard copy at the OEI Docket, EPA/ DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OEI Docket is (202) 566–1752. Note: The EPA Docket Center suffered damage due to flooding during the last week of June 2006. The Docket Center is continuing to operate. However, during the cleanup, there will be temporary changes to Docket Center telephone numbers, addresses, and hours of operation for people who wish to visit the Public Reading Room to view documents. Consult EPA’s Federal Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at http:// www.epa.gov/epahome/dockets.htm for current information on docket status, locations and telephone numbers. FOR FURTHER INFORMATION CONTACT: For more specific information or technical questions relating to this rule, contact Marc Edmonds, Toxics Release Inventory Program Division, Office of Information Analysis and Access (2844T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202–566–0758; fax number: 202–566–0741; e-mail: edmonds.marc@epa.gov; or Larry Reisman, Toxics Release Inventory Program Division, Office of Information Analysis and Access (2844T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202–566– 0751; fax number: 202–566–0741; e- PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 mail: reisman.larry@epa.gov. The press point of contact for this rule is Suzanne Ackerman, Office of Public Affairs, 202– 564–7819. For general inquiries relating to the Toxics Release Inventory or more information on EPCRA section 313, contact the TRI Information Center; toll free: 1–800–424–9346, in Virginia and Alaska: 703–412–9810, toll free TDD: 1– 800–553–7672, or TDD DC area local: 703–412–3323. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? This action applies to facilities that submit annual reports under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and section 6607 of the Pollution Prevention Act (PPA). It specifically applies to those that submit the TRI Form R or Form A Certification Statement. (See http://www.epa.gov/tri/ report/index.htm#forms for detailed information about EPA’s TRI reporting forms.) To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in part 372, subpart B, of Title 40 of the Code of Federal Regulations. If you have questions regarding the applicability of this action to a particular entity, consult the individuals listed in the preceding FOR FURTHER INFORMATION CONTACT section. This action is also relevant to those who utilize EPA’s TRI information, including State agencies, local governments, communities, environmental groups and other nongovernmental organizations, as well as members of the general public. II. What is EPA’s Statutory Authority for Taking This Action? This rule is being issued under sections 313(f)(2) and 328 of EPCRA, 42 U.S.C. 11023(f)(2) and 11048. In general, section 313 of EPCRA and section 6607 of the PPA require owners and operators of facilities in specified Standard Industrial Classification (SIC) codes that manufacture, process, or otherwise use a listed toxic chemical in amounts above specified threshold levels to report certain facility-specific information about such chemicals, including the annual releases and other waste management quantities. This information is submitted on EPA Form 9350–1 (Form R) or EPA Form 9350–2 (Form A) and compiled in an annual Toxics Release Inventory (TRI). Each covered facility must file a separate Form R for each listed chemical manufactured, processed, or otherwise used in excess of applicable reporting E:\FR\FM\22DER1.SGM 22DER1

Agencies

[Federal Register Volume 71, Number 246 (Friday, December 22, 2006)]
[Rules and Regulations]
[Pages 76927-76932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21843]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0935; FRL-8105-6]


Flucarbazone-sodium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for combined residues 
of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-carboxamide, 
sodium salt and its N-desmethyl metabolite in or on wheat, forage at 
0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 
0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of 
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding 
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver 
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. Arysta 
LifeScience North America Corporation, 15401 Weston Parkway, Suite 150, 
Cary, NC 27513 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 December 22, 2006. Objections and 
requests for hearings must be received on or before February 20, 2007, 
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-2006-0935. All documents in the 
docket are listed in the index for the docket. 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

[[Page 76928]]

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 Building), 2777 S. Crystal 
Drive, Arlington, VA. The 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 
(7505P), 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?

    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 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 the FFDCA, as amended by the 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. 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-2006-0935. 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 February 20, 2007.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0935, 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 
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of October 20, 2006 (70 FR 61969) (FRL-
8099-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6F7112) by Arysta LifeScience North America Corporation, 15401 Weston 
Parkway, Suite 150, Cary, NC 27513. The petition requested that 40 CFR 
180.562 be amended by establishing a tolerance for combined residues of 
flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-carboxamide, 
sodium salt and its N-desmethyl metabolite in or on wheat, forage at 
0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 
0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of 
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding 
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver 
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. That notice 
included a summary of the petition prepared by Arysta LifeScience North 
America Corporation, the registrant. There were no comments received in 
response to the notice of filing.
    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 the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

[[Page 76929]]

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, for a tolerance for combined residues of 
flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-carboxamide, 
sodium salt and its N-desmethyl metabolite in or on wheat, forage at 
0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 
0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of 
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding 
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver 
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. 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. Specific information on the studies received and the nature 
of the toxic effects caused by flucarbazone-sodium as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://
docket.epa.gov/edkpub/index.jsp.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://docket.epa.govedkpub/index.jsp.
    A summary of the toxicological endpoints for flucarbazone-sodium 
used for human risk assessment is discussed in Unit III.B. of the final 
rule published in the Federal Register of September 29, 2000 (65 FR 
58364) (FRL-6745-9).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.562) for the combined residues of flucarbazone-
sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-carboxamide, 
sodium salt and its N-desmethyl metabolite in or on wheat, forage at 
0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 
0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of 
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding 
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver 
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. Risk assessments 
were conducted by EPA to assess dietary exposures from flucarbazone-
sodium 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.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated 
the individual food consumption as reported by respondents in the USDA 
1989-1992 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: 
A summary of the acute dietary exposure assessment is discussed in Unit 
III.C of the final rule published in the Federal Register of September 
29, 2000 (65 FR 58364).
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the (DEEM\TM\) analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 Nationwide 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: A summary of the chronic dietary exposure assessment is 
discussed in Unit III.C. of the final rule published in the Federal 
Register of September 29, 2000 (65 FR 58364).
    iii. Cancer. A summary of the dietary exposure assessment is 
discussed in Unit III.C. of the final rule published in the Federal 
Register of September 29, 2000 (65 FR 58364).
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to section 408(f)(1) require that data be provided 5 years after the 
tolerance is established, modified, or left in effect, demonstrating 
that the levels in food are not above the levels anticipated. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. For the present action, EPA will 
issue such Data Call-Ins for information relating to anticipated 
residues as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such Data Call-Ins will be required to 
be submitted no later than 5 years from the date of issuance of this 
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for flucarbazone-sodium 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 
physical characteristics of flucarabazone-sodium. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://docket.epa.gov/edkpub/index.jsp.
    Based on the Generic Expected Environmental Concentration (GENEEC)

[[Page 76930]]

and Screening Concentrations in Groundwater (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of flucarbazone-sodium 
for acute exposures are estimated to be 1.42 parts per billion (ppb) 
for surface water and 0.2 ppb for ground water. The EECs for chronic 
exposures are estimated to be 1.25 ppb for surface water and 0.2 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).
    Flucarbazone-sodium 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 flucarbazone-sodium and 
any other substances and flucarbazone-sodium 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 
flucarbazone-sodium 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 Office of Pesticide Programs 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 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 data base 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 
Margin of exposure 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. A summary of the prenatal 
and postnatal sensitivity assessment is discussed in the Federal 
Register of September 29, 2000 (65 FR 58364).
    3. Conclusion. There is a complete toxicity data base for 
flucarbazone-sodium and exposure data are complete or are estimated 
based on data that reasonably accounts for potential exposures. A 
summary of the safety factor is discussed in Unit III.D. of the final 
rule published in the Federal Register of September 29, 2000 (65 FR 
58364).

E. Aggregate Risks and Determination of Safety

    1. Acute risk. A summary of the acute risk assessment is discussed 
in Unit III.E. of the final rule published in the Federal Register of 
September 29, 2000 (65 FR 58364).
    2. Chronic risk. A summary of the chronic risk assessment is 
discussed in Unit III.E. of the final rule published in the Federal 
Register of September 29, 2000 (65 FR 58364).
    3. Short-term risk. A summary of the short-term risk assessment is 
discussed in Unit III.E. of the final rule published in the Federal 
Register of September 29, 2000 (65 FR 58364).
    4. Intermediate-term risk. A summary of the intermediate-term risk 
assessment is discussed in Unit III.E. of the final rule published in 
the Federal Register of September 29, 2000 (65 FR 58364).
    5. Aggregate cancer risk for U.S. population. A summary of the 
aggregate cancer risk for U.S. population assessment is discussed in 
Unit III.E. of the final rule published in the Federal Register of 
September 29, 2000 (65 FR 58364).
    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, and to infants and children from aggregate 
exposure to flucarbazone-sodium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed residue analytical methods for 
tolerance enforcement in wheat and livestock commodities. The 
analytical enforcement method for wheat employs accelerated solvent 
extraction, clean-up using solid phase extraction columns followed by 
detection and quantitation by liquid chromatography/tandem mass 
spectroscopy (LC/MS/MS). The analytical method for livestock 
commodities is a common moiety method which measures residues of 
flucarbazone-sodium (MKH 6562) in animal tissues and milk by extracting 
and hydrolyzing MKH 6562 and MKH 6562-related residues to MKH 6562 
sulfonamide. Detection is achieved using negative ion electrospray mass 
spectrometry using deuterated MKH 6562 sulfonamide as an internal 
standard. Both methods have undergone successful validations by 
independent laboratories and have been accepted by the Agency. The 
analytical standards for these methods are available 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.

B. International Residue Limits

    A default Maximum Residue Limit (MRL) of 0.01 ppm has been 
established in Canada for residues of flucarbazone-sodium and its N-
desmethyl metabolite on wheat grain. This value is consistent with the 
tolerance being established in the United States on wheat grain. There 
are no Codex MRLs for this compound on wheat. Therefore, no 
compatibility issues exist with Codex in regard to the U.S. tolerances 
discussed in this review.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-carboxamide, 
sodium salt and its N-desmethyl metabolite in or on wheat, forage at 
0.30 parts per million (ppm); wheat, grain at 0.01 ppm; wheat, hay at 
0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of 
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding 
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver 
of cattle, goats, hogs, horses, and sheep at 1.5 ppm.

[[Page 76931]]

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 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. The Agency hereby certifies that this rule will not 
have significant negative economic impact on a substantial number of 
small entities. 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 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.

VII. 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).

List of Subjects in 40 CFR Part 180

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

    Dated: December 14, 2006.
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 180.562, paragraph (a) is revised to read as follows:


Sec. 180.562  Flucarbazone-sodium; tolerances for residues.

    (a) General. Tolerances are established for combined residues of 
the herbicide flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-
oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole 1-
carboxamide, sodium salt) and its N-desmethyl metabolite; and its 
metabolites converted to 2-(trifluoromethoxy)benzene sulfonamide and 
calculated as flucarbazone-sodium in or on the following food 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, liver..............................................         1.50
Cattle, meat...............................................         0.01
Cattle, meat byproducts except liver.......................         0.01
Goat, liver................................................         1.50
Goat, meat.................................................         0.01
Goat, meat byproducts except liver.........................         0.01
Hog, liver.................................................         1.50
Hog, meat..................................................         0.01
Hog, meat byproducts except liver..........................         0.01
Horse, liver...............................................         1.50
Horse, meat................................................         0.01
Horse, meat by-products except liver.......................         0.01
Milk.......................................................        0.005
Sheep, liver...............................................         1.50
Sheep, meat................................................         0.01
Sheep, meat byproducts except liver........................         0.01
Wheat, forage..............................................         0.30
Wheat, grain...............................................         0.01
Wheat, hay.................................................         0.10
Wheat, straw...............................................         0.05
------------------------------------------------------------------------


[[Page 76932]]

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[FR Doc. E6-21843 Filed 12-21-06; 8:45 am]
BILLING CODE 6560-50-S