Fluthiacet-methyl; Pesticide Tolerance, 77620-77625 [E6-22126]

Download as PDF 77620 Federal Register / Vol. 71, No. 248 / Wednesday, December 27, 2006 / Rules and Regulations implications.’’ This direct final rule does not have tribal implications, as specified in Executive Order 13175. Today’s direct final rule will affect only those refiners, importers or blenders of gasoline that choose to produce or import RFG for sale in the East St. Louis ozone nonattainment area, and gasoline distributors and retail stations in those areas. Thus, Executive Order 13175 does not apply to this rule. G. Executive Order 13045: Protection of Children From Environmental Health & Safety Risks Executive Order 13045, entitled Protection of Children from Environmental Health and Safety Risks, (62 FR 19885, April 23, 1997) applies to any rule that: (1) As determined to be ‘‘economically significant’’ as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5–501 of the Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045 because it is not economically significant. rwilkins on PROD1PC63 with RULES H. Executive Order 13211: Actions That Significantly Affect Energy Supply 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)] because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer Advancement Act Section 12(d) of Public Law 104–113, the National Technology Transfer and Advancement Act of 1995 (NTTAA), directs us to use voluntary consensus standards in our regulatory activities unless it would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) developed or adopted by voluntary consensus standards bodies. The VerDate Aug<31>2005 17:07 Dec 26, 2006 Jkt 211001 NTTAA directs us to provide Congress, through OMB, explanations when we decide not to use available and applicable voluntary consensus standards. This direct final rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards. J. Statutory Authority The Statutory authority for the action finalized today is granted to EPA by sections 211(c) and (k) and 301 of the Clean Air Act, as amended; 42 U.S.C. 7545(c) and (k) and 7601. K. 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 the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). This rule will be effective May 1, 2007. List of Subjects in 40 CFR Part 80 Environmental protection, Air pollution control, Fuel additives, Gasoline, Motor vehicle pollution. Dated: December 20, 2006. Stephen L. Johnson, Administrator. I 40 CFR part 80 is amended as follows: PART 80—[AMENDED] 1. The authority citation for part 80 continues to read as follows: I Authority: 42 U.S.C. 7414, 7545, 7542, and 7601(a). 2. Section 80.70 is amended by adding paragraph (k)(2) to read as follows: I § 80.70 Covered areas. * * * * * (k) * * * (2) The Illinois portion of the St. Louis, MO–IL 8-hour ozone nonattainment area is a covered area beginning June 1, 2007. The prohibitions of section 211(k)(5) of the Clean Air Act apply to all persons other than retailers and wholesale purchaserconsumers in the Illinois portion of the PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 St. Louis, MO–IL 8-hour ozone nonattainment area beginning May 1, 2007. The prohibitions of section 211(k)(5) of the Clean Air Act apply to retailers and wholesale purchaserconsumers in the Illinois portion of the St. Louis, MO–IL 8-hour ozone nonattainment area beginning June 1, 2007. * * * * * [FR Doc. E6–22162 Filed 12–26–06; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–0788; FRL–8108–8] Fluthiacet-methyl; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes a tolerance for combined residues of fluthiacet-methyl in or on cotton, gin byproducts and cotton, undelinted seed. K-I Chemical U.S.A. Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective December 27, 2006. Objections and requests for hearings must be received on or before February 26, 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–2006–0788. 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 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. E:\FR\FM\27DER1.SGM 27DER1 Federal Register / Vol. 71, No. 248 / Wednesday, December 27, 2006 / Rules and Regulations 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: • 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. rwilkins on PROD1PC63 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 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http:// www.gpoaccess.gov/ecfr. VerDate Aug<31>2005 17:07 Dec 26, 2006 Jkt 211001 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–2006–0788 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 26, 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–2006–0788, by one of the following methods: • Federal e Rule making 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 September 20, 2006 (71 FR 54987) (FRL–8094–7), 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 7F4821) by K-I Chemical U.S.A. Inc., 11 Martine Avenue, Suite 970, White Plains, NY 10606. The petition requested that 40 CFR 180.551 be amended by PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 77621 establishing a tolerance for combined residues of the herbicide, fluthiacetmethyl, acetic acid, [[2-chloro-4-fluoro5-[(tetrahydro-3-oxo-1H,3H[1,3,4]thiadiazolo[3,4-a]pyridazin-1ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4a]pyridazin-1ylidene)amino]phenyl]thio]-, in or on the food/feed commodities: Cotton, gin byproducts at 0.20 part per million (ppm) and cotton, undelinted seed at 0.020 ppm. That notice included a summary of the petition prepared by KI Chemical U.S.A. Inc., 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. 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 fluthiacet-methyl in or on cotton, gin byproducts at 0.20 ppm and cotton, undelinted seed at 0.020 ppm. EPA’s assessment of exposures and risks E:\FR\FM\27DER1.SGM 27DER1 77622 Federal Register / Vol. 71, No. 248 / Wednesday, December 27, 2006 / Rules and Regulations C. Exposure Assessment 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 fluthiacet-methyl as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies are discussed in the Federal Register of December 21, 2001 (66 FR 65839) (FRL– 6806–7). rwilkins on PROD1PC63 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 in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF or 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. 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://www.epa.gov/ fedrgstr/EPA-PEST/1997/November/ Day-26/p30948.htm. A summary of the toxicological endpoints for fluthiacet-methyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of December 21, 2001 (66 FR 65839) (FRL–6806–7). VerDate Aug<31>2005 17:07 Dec 26, 2006 Jkt 211001 1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.551) for the residues of fluthiacet-methyl, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from fluthiacet-methyl 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. No such effects were identified in the toxicological studies for fluthiacetmethyl; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM), which incorporates food consumption data as reported by respondents in the USDA 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues were assumed and refined with average values of current and projected percent crop treated (PCT) estimates. Refined current PCT estimates for field corn, sweet corn and soybeans were determined to be on average <1% and at a maximum 1%; and projected PCT estimates for cotton were determined to be on average 30% and at a maximum 34%. iii. Cancer. The Hazard Identification Assessment Review Committee classified fluthiacet-methyl as likely to be a human carcinogen. Chronic and cancer exposure assessement. Chronic and cancer exposures were determined to be dietary from residues in raw agricultural commodities derived from the use of fluthiacet-methyl for defoliating cotton and from water. HED determined that dietary exposure to residues of fluthiacet-methyl and it acid metabolite (CGA-300402) in or on cotton gin byproducts at 0.20 ppm and in or on cotton undelinted seed at 0.020 were anticipated from the proposed usepattern. These tolerance level exposures were used in the risk assessment. In addition, Estimated Drinking Water Concentrations (EDWCs) were determined by modeling (PRZM/ EXAMS, Tier II) for California, the PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 highest found level of potential residues for chronic (0.19 µg/L) and for cancer (0.14 µg) 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. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: The assumptions of the dietary exposure analysis were tolerance level residues, modified by default processing factors and percent crop treated (PCT) data. The resulting chronic and cancer dietary assessments were classified as Tier 2 assessments and are considered to be partially refined. PCT information came from EPA’s refined usage analysis. Refined current PCT estimates for field corn, sweet corn and soybeans were determined to be on average <1%, and at a maximum 1%. Projected PCT estimates for cotton were E:\FR\FM\27DER1.SGM 27DER1 rwilkins on PROD1PC63 with RULES Federal Register / Vol. 71, No. 248 / Wednesday, December 27, 2006 / Rules and Regulations determined to be on average, 30%, and at a maximum 34%. Because the estimated average PCTs for field corn, sweet corn and soybeans were less than 1%, they were rounded up to 1% for use in the chronic and cancer dietary assessments. The estimated average PCT for cotton was used for both the chronic and cancer assessment. There were no data on pop corn; therefore, 100% crop treated defaults were used. Default DEEM 7.81 processing factors were applied to corn, field, syrup and corn, field, syrup-babyfood. EPA concluded that residues of fluthiacet-methyl and its acid metabolite CGA-300403, were not expected to accumulate in livestock tissues; therefore, livestock commodities were not factored into the dietary risk assessment. The Agency believes that the three conditions listed in Unit IV.C.1. have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations are taken into account through EPA’s computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA’s risk assessment process ensures that EPA’s exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which fluthiacet-methyl may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fluthiacet-methyl 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 fluthiacetmethyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed/ models/water/index.htm. VerDate Aug<31>2005 17:07 Dec 26, 2006 Jkt 211001 Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System and Sreening Concentrations in Groundwater models, the estimated environmental concentrations (EECs) of fluthiacet-methyl for acute exposures are estimated to be between 0.23 and 1.0 parts per billion (ppb) for surface water and 0.08 ppb for ground water. The EECs for chronic and cancer exposures are estimated to be 0.19 and 0.l4, respectively. 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). Fluthiacet-methyl 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 the 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 fluthiacet-methyl and any other substances and fluthiacet-methyl 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 fluthiacet-methyl 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 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 77623 toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. There is no quantitative or qualitative evidence or increased susceptibility of rat and rabbit fetuses to in utero exposure to fluthiacet-methyl in developmental toxicity studies. There is no quantitative or qualitative evidence of increased susceptibility to fluthiacetmethyl following prenatal/postnatal exposure to a 2–generation reproduction study. 3. Conclusion. EPA concluded based on reliable data that it would be safe to remove the additional 10X safety factor for the protection of infants and children. This conclusion was based on the following findings: i. There is no quantitative or qualitative evidence of increased susceptibility to fluthiacet-methyl following prenatal/postnatal exposure; ii. There is no concern for developmental neurotoxicity resulting from exposure to fluthiacet-methyl. A developmental neurotoxicity study is not required; iii. The toxicological data base is complete for FQPA assessment; iv. The chronic dietary food exposure assessment utilizes tolerance level residues and 34% of cotton and 1% corn and soybean crop treated information for all commodities. By using these screening-level residue values and conservative percent crop treated assessment, actual exposures/ risks will not be underestimated; and v. The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters that are designed to provide conservative, health protective, high-end estimates of water concentrations that will not likely be exceeded. E. Aggregate Risks and Determination of Safety 1. Acute risk. An effect of concern attributable to a single exposure (dose) E:\FR\FM\27DER1.SGM 27DER1 77624 Federal Register / Vol. 71, No. 248 / Wednesday, December 27, 2006 / Rules and Regulations was not identified from the oral toxicity studies including the developmental toxicity studies in rat and rabbits. No acute risk is expected from exposure to fluthiacet-methyl. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fluthiacet-methyl from food will utilize <1% of the cPAD for the U.S. population, 1.4% of the cPAD for all infant <1 year old. There are no residential uses for fluthiacet-methyl that results in chronic residential exposure to fluthiacet-methyl. 3. Short-term risk. Fluthiacet-methyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency’s level of concern. 4. Aggregate cancer risk for U.S. population. The overall cancer dietary risk for the U.S. population is 7.51 x 10-7, based on dietary (food and drinking water exposures). 5. 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 fluthiacetmethyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography/mass spectrometry method which uses negative ion chemical ionization (GC/NCI-MS) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; e-mail address: residuemethods@epa.gov. B. International Residue Limits There are no Codex, Canadian or Mexican maximum residue limits established for fluthiacet-methyl on corn, cotton and soybean commodities or on meat and milk commodities. rwilkins on PROD1PC63 with RULES V. Conclusion Therefore, the tolerance is established for combined residues of Fluthiacetmethyl, acetic acid, [[2-chloro-4-fluoro5-[(tetrahydro-3-oxo-1H,3H[1,3,4]thiadiazolo[3,4-a]pyridazin-1ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4a]pyridazin-1- VerDate Aug<31>2005 17:07 Dec 26, 2006 Jkt 211001 ylidene)amino]phenyl]thio]-, in or on cotton, gin byproducts at 0.20 ppm and cotton, undelinted seed at 0.020 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 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 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 E:\FR\FM\27DER1.SGM 27DER1 Federal Register / Vol. 71, No. 248 / Wednesday, December 27, 2006 / Rules and Regulations 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 19, 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. Final rule, announcement of effective date. ACTION: SUMMARY: The Federal Communications Commission (FCC) received Office of Management and Budget (OMB) approval on December 12, 2006 for new public information collection requirements contained in the FCC’s Communications Assistance for Law Enforcement Act and Broadband Access and Services, Second Report and Order and Memorandum Opinion and Order (CALEA Second Report and Order) in 71 FR 38091, July 5, 2006, OMB Control Number 3060–0809, pursuant to the requirements of the Paperwork Reduction Act of 1995, Public Law 104– 13. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid control number. I 2. Section 180.551 is amended by redesignating existing paragraph (a) as (a)(1), and adding paragraph (a)(2) to read as follows. DATES: § 180.551 Fluthiacet-methyl; tolerances for residues. FOR FURTHER INFORMATION CONTACT: rwilkins on PROD1PC63 with RULES (a) General. (1) * * * (2) A tolerance is established for the combined residues of the herbicide fluthiacet-methyland its acid metabolite: acetic acid, [[2-chloro-4-fluoro-5[tetrahydro-3-oxo-1H,3H[1,3,4]thiadiazolo[3,4-a]pyridazin-1ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4a]pyridazin-1ylidene)amino]phenyl]thio]- , in or on the following food commodities: The rules for §§ 1.20004 and 1.20005 published at 71 FR 38091, July 5, 2006, are effective December 12, 2006. Thomas J. Beers, Public Safety and Homeland Security Bureau, Policy Division, 445 12th Street, SW., Washington, DC 20554, at (202) 418– 0952. For additional information concerning the Paperwork Reduction Act information collection requirements, contact Judith B. Herman at (202) 418– 0124, or via the Internet at JudithB.Herman@fcc.gov. The CALEA Second Report and Order noted that the effective date for the new CALEA information collection Parts per requirements was subject to Office of Commodity million Management and Budget (OMB) approval. OMB granted its approval on Cotton, gin byproducts ............. 0.20 December 12, 2006. Accordingly, (1) an Cotton undelinted seed ............ 0.020 attesting letter for pending CALEA section 107(c)(1) petitions currently on * * * * * file with the FCC must be filed by [FR Doc. E6–22126 Filed 12–26–06; 8:45 am] February 12, 2007; (2) compliance BILLING CODE 6560–50–S monitoring reports (FCC Form 445) must be filed by February 12, 2007; (3) system security and integrity (SSI) plans for providers of facilities-based FEDERAL COMMUNICATIONS broadband internet access and COMMISSION interconnected Voice over Internet Protocol (VoIP) services must be filed by 47 CFR Part 1 March 12, 2007.1 [ET Docket No. 04–295; FCC 06–56] Compliance with new CALEA section 107(c) and 109(b) petition filing Communications Assistance for Law Enforcement Act and Broadband 1 Communications Assistance for Law Access and Services Enforcement Act and Broadband Access and Federal Communications Commission. AGENCY: VerDate Aug<31>2005 17:07 Dec 26, 2006 Jkt 211001 SUPPLEMENTARY INFORMATION: Services, ET Docket No. 04–295, Public Notice DA O6–2511, Public Notice DA 06–2512, and Public Notice DA 06–2513. PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 77625 requirements 2 became effective upon OMB authorization, i.e., December 12, 2006. CALEA requires the FCC to create rules that regulate the conduct and recordkeeping of lawful electronic surveillance. On May 12, 2006, the FCC released its CALEA Second Report and Order which became effective August 4, 2006, except for certain information collections which required OMB approval under the Paperwork Reduction Act before the FCC could enforce them. Now that OMB approval has been granted: (a) Each provider that has a CALEA section 107(c)(1) extension petition currently on file must submit to the FCC an attesting letter documenting that the provider’s equipment, facility or service continues to qualify for compliance extension relief, given that CALEA section 107(c)(1) applies only to equipment, facilities, or services installed or deployed prior to October 25, 1998. (b) Facilities-based broadband Internet access and interconnected VoIP service providers must file system security and integrity (SSI) plans under the Commission’s rules. SSI plans are currently approved under the existing OMB 3060–0809 information collection.3 (c) All providers of facilities-based broadband Internet access or interconnected VoIP services must file monitoring reports on FCC Form 445, ‘‘CALEA Monitoring Report for Broadband and VoIP Services,’’ with the FCC to ensure timely CALEA compliance. (d) There are new requirements governing petitions filed under section 107(c)(1), which request additional time to comply with CALEA; these provisions apply to all providers subject to CALEA and are voluntary filings. (e) There are modified requirements governing petitions filed under section 109(b) request for reimbursement of CALEA; these provisions apply to all providers subject to CALEA and are voluntary filings. Federal Communications Commission. William F. Caton, Deputy Secretary. [FR Doc. E6–22155 Filed 12–26–06; 8:45 am] BILLING CODE 6712–01–P 2 See Communications Assistance for Law Enforcement Act and Broadband Access and Services, ET Docket No. 04–295, Second Report and Order and Memorandum Opinion and Order, 21 FCC Rcd 5360 (2006), Appendices E and F. 3 See 65 FR 8666 (2000). E:\FR\FM\27DER1.SGM 27DER1

Agencies

[Federal Register Volume 71, Number 248 (Wednesday, December 27, 2006)]
[Rules and Regulations]
[Pages 77620-77625]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22126]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0788; FRL-8108-8]


Fluthiacet-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of fluthiacet-methyl in or on cotton, gin byproducts and cotton, 
undelinted seed. K-I Chemical U.S.A. Inc. requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective December 27, 2006. Objections and 
requests for hearings must be received on or before February 26, 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-2006-0788. 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 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.

[[Page 77621]]


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:
     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-2006-0788 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 26, 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-2006-0788, by one of the following methods:
     Federal e Rule making 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 September 20, 2006 (71 FR 54987) (FRL-
8094-7), 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 
7F4821) by K-I Chemical U.S.A. Inc., 11 Martine Avenue, Suite 970, 
White Plains, NY 10606. The petition requested that 40 CFR 180.551 be 
amended by establishing a tolerance for combined residues of the 
herbicide, fluthiacet-methyl, acetic acid, [[2-chloro-4-fluoro-5-
[(tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite, 
acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-, 
in or on the food/feed commodities: Cotton, gin byproducts at 0.20 part 
per million (ppm) and cotton, undelinted seed at 0.020 ppm. That notice 
included a summary of the petition prepared by K-I Chemical U.S.A. 
Inc., 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.

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 
fluthiacet-methyl in or on cotton, gin byproducts at 0.20 ppm and 
cotton, undelinted seed at 0.020 ppm. EPA's assessment of exposures and 
risks

[[Page 77622]]

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 fluthiacet-methyl 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 
Federal Register of December 21, 2001 (66 FR 65839) (FRL-6806-7).

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. An UF or 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    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://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for fluthiacet-methyl used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of December 21, 2001 (66 FR 65839) 
(FRL-6806-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.551) for the residues of fluthiacet-methyl, in 
or on a variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from fluthiacet-methyl 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.
    No such effects were identified in the toxicological studies for 
fluthiacet-methyl; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: Tolerance level residues were assumed and refined with 
average values of current and projected percent crop treated (PCT) 
estimates. Refined current PCT estimates for field corn, sweet corn and 
soybeans were determined to be on average <1% and at a maximum 1%; and 
projected PCT estimates for cotton were determined to be on average 30% 
and at a maximum 34%.
    iii. Cancer. The Hazard Identification Assessment Review Committee 
classified fluthiacet-methyl as likely to be a human carcinogen.
    Chronic and cancer exposure assessement. Chronic and cancer 
exposures were determined to be dietary from residues in raw 
agricultural commodities derived from the use of fluthiacet-methyl for 
defoliating cotton and from water. HED determined that dietary exposure 
to residues of fluthiacet-methyl and it acid metabolite (CGA-300402) in 
or on cotton gin byproducts at 0.20 ppm and in or on cotton undelinted 
seed at 0.020 were anticipated from the proposed use-pattern. These 
tolerance level exposures were used in the risk assessment. In 
addition, Estimated Drinking Water Concentrations (EDWCs) were 
determined by modeling (PRZM/EXAMS, Tier II) for California, the 
highest found level of potential residues for chronic (0.19 [mu]g/L) 
and for cancer (0.14 [mu]g)
    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.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings: Condition 1, 
that the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows: The assumptions of the 
dietary exposure analysis were tolerance level residues, modified by 
default processing factors and percent crop treated (PCT) data. The 
resulting chronic and cancer dietary assessments were classified as 
Tier 2 assessments and are considered to be partially refined.
    PCT information came from EPA's refined usage analysis. Refined 
current PCT estimates for field corn, sweet corn and soybeans were 
determined to be on average <1%, and at a maximum 1%. Projected PCT 
estimates for cotton were

[[Page 77623]]

determined to be on average, 30%, and at a maximum 34%. Because the 
estimated average PCTs for field corn, sweet corn and soybeans were 
less than 1%, they were rounded up to 1% for use in the chronic and 
cancer dietary assessments. The estimated average PCT for cotton was 
used for both the chronic and cancer assessment. There were no data on 
pop corn; therefore, 100% crop treated defaults were used. Default DEEM 
7.81 processing factors were applied to corn, field, syrup and corn, 
field, syrup-babyfood. EPA concluded that residues of fluthiacet-methyl 
and its acid metabolite CGA-300403, were not expected to accumulate in 
livestock tissues; therefore, livestock commodities were not factored 
into the dietary risk assessment.
    The Agency believes that the three conditions listed in Unit 
IV.C.1. have been met. With respect to Condition 1, PCT estimates are 
derived from Federal and private market survey data, which are reliable 
and have a valid basis. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation. 
As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations are taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which fluthiacet-
methyl may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fluthiacet-methyl 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 fluthiacet-methyl. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System and Sreening Concentrations in Groundwater models, the estimated 
environmental concentrations (EECs) of fluthiacet-methyl for acute 
exposures are estimated to be between 0.23 and 1.0 parts per billion 
(ppb) for surface water and 0.08 ppb for ground water. The EECs for 
chronic and cancer exposures are estimated to be 0.19 and 0.l4, 
respectively.
    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). Fluthiacet-methyl 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 the 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 fluthiacet-methyl and any 
other substances and fluthiacet-methyl 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 fluthiacet-methyl 
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 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no quantitative or 
qualitative evidence or increased susceptibility of rat and rabbit 
fetuses to in utero exposure to fluthiacet-methyl in developmental 
toxicity studies. There is no quantitative or qualitative evidence of 
increased susceptibility to fluthiacet-methyl following prenatal/
postnatal exposure to a 2-generation reproduction study.
    3. Conclusion. EPA concluded based on reliable data that it would 
be safe to remove the additional 10X safety factor for the protection 
of infants and children. This conclusion was based on the following 
findings:
    i. There is no quantitative or qualitative evidence of increased 
susceptibility to fluthiacet-methyl following prenatal/postnatal 
exposure;
    ii. There is no concern for developmental neurotoxicity resulting 
from exposure to fluthiacet-methyl. A developmental neurotoxicity study 
is not required;
    iii. The toxicological data base is complete for FQPA assessment;
    iv. The chronic dietary food exposure assessment utilizes tolerance 
level residues and 34% of cotton and 1% corn and soybean crop treated 
information for all commodities. By using these screening-level residue 
values and conservative percent crop treated assessment, actual 
exposures/risks will not be underestimated; and
    v. The dietary drinking water assessment utilizes water 
concentration values generated by model and associated modeling 
parameters that are designed to provide conservative, health 
protective, high-end estimates of water concentrations that will not 
likely be exceeded.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An effect of concern attributable to a single 
exposure (dose)

[[Page 77624]]

was not identified from the oral toxicity studies including the 
developmental toxicity studies in rat and rabbits. No acute risk is 
expected from exposure to fluthiacet-methyl.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fluthiacet-methyl from food will utilize <1% of the cPAD for the U.S. 
population, 1.4% of the cPAD for all infant <1 year old. There are no 
residential uses for fluthiacet-methyl that results in chronic 
residential exposure to fluthiacet-methyl.
    3. Short-term risk. Fluthiacet-methyl is not registered for use on 
any sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which do not 
exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. The overall cancer 
dietary risk for the U.S. population is 7.51 x 10-7, based 
on dietary (food and drinking water exposures).
    5. 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 fluthiacet-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/mass 
spectrometry method which uses negative ion chemical ionization (GC/
NCI-MS) is available to enforce the tolerance expression. The method 
may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
established for fluthiacet-methyl on corn, cotton and soybean 
commodities or on meat and milk commodities.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
Fluthiacet-methyl, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-
oxo-1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite, 
acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-, 
in or on cotton, gin byproducts at 0.20 ppm and cotton, undelinted seed 
at 0.020 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 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that 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

[[Page 77625]]

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 19, 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 180.551 is amended by redesignating existing paragraph (a) 
as (a)(1), and adding paragraph (a)(2) to read as follows.


Sec.  180.551  Fluthiacet-methyl; tolerances for residues.

    (a) General. (1) * * *
    (2) A tolerance is established for the combined residues of the 
herbicide fluthiacet-methyland its acid metabolite: acetic acid, [[2-
chloro-4-fluoro-5-[tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-
[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-methyl ester, and its 
acid metabolite, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-
1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]- , in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts.....................................         0.20
Cotton undelinted seed.....................................        0.020
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-22126 Filed 12-26-06; 8:45 am]
BILLING CODE 6560-50-S