Fluopicolide; Pesticide Tolerance, 14443-14447 [E7-5628]

Download as PDF Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Rules and Regulations 14443 Appendix Q to Subpart G of Part 82— Unacceptable Substitutes Listed in the March 28, 2007 Final Rule, Effective May 29, 2007. FOAM BLOWING UNACCEPTABLE SUBSTITUTES End use Substitute Decision —Rigid polyurethane commercial refrigeration ............... —Rigid polyurethane sandwich panels. HCFC–22; HCFC–142b as substitutes for HCFC– 141b. Unacceptable 1 .................. Alternatives exist with lower or zero-ODP. HCFC–22; HCFC–142b as substitutes for CFCs. Unacceptable 2 .................. Alternatives exist with lower or zero-ODP. —Rigid polyurethane slabstock and other foams. —Rigid polyurethane and polyisocyanurate laminated boardstock. —Rigid polyurethane appliance. —Rigid polyurethane spray and commercial refrigeration, and sandwich panels. —Rigid polyurethane slabstock and other foams. —Polystyrene extruded insulation boardstock and billet. —Phenolic insulation board and bunstock. —Flexible polyurethane. —Polystyrene extruded sheet. Further information 1 For existing users of HCFC–22 and HCFC–142b as of November 4, 2005 other than in marine applications, the unacceptability determination is effective on March 1, 2008; for existing users of HCFC–22 and HCFC–142b as of November 4, 2005 in marine applications, including marine flotation foam, the unacceptability determination is effective on September 1, 2009. For an existing user of HCFC–22 or HCFC–142b that currently operates in only one facility that it does not own, and is scheduled to transition to a non-ODS, flammable alternative to coincide with a move to a new facility and installation of new process equipment that cannot be completed by March 1, 2008, the unacceptability determination is effective January 1, 2010. 2 For existing users of HCFC–22 and HCFC–142b in polystyrene extruded insulation boardstock and billet and the other foam end uses, as of November 4, 2005, the unacceptability determination is effective on January 1, 2010. Unit I.C. of the SUPPLEMENTARY 3. In Appendix K to Subpart G, the second table (Foam Blowing— Acceptable Substitutes) is removed. I INFORMATION). BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–481; FRL–8120–1] Fluopicolide; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. pwalker on PROD1PC71 with RULES AGENCY: SUMMARY: This regulation establishes tolerances for residues of fluopicolide in or on imported grape at 2.0 parts per million (ppm), and grape, raisin at 6.0 ppm with no U.S. registration. Bayer CropScience AG requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The tolerance petition and data was transferred to Valent U.S.A. Corporation on January 9, 2006. DATES: This regulation is effective March 28, 2007. Objections and requests for hearings must be received on or before May 29, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also VerDate Aug<31>2005 16:03 Mar 27, 2007 Jkt 211001 A. Does This Action Apply to Me? EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2006–0481. 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 https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805. ADDRESSES: [FR Doc. E7–5491 Filed 3–27–07; 8:45 am] FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6129; e-mail address: janet.whitehurst@epa.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00051 Fmt 4700 I. General Information Sfmt 4700 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 code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather 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 E:\FR\FM\28MRR1.SGM 28MRR1 14444 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Rules and Regulations the person listed under FOR FURTHER INFORMATION CONTACT. pwalker on PROD1PC71 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 https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://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 https:// 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–2006–0481 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 May 29, 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– 2006–0481, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, VerDate Aug<31>2005 16:03 Mar 27, 2007 Jkt 211001 excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 3055805. II. Petition for Tolerance In the Federal Register of January 24, 2007 (72 FR 3132) (FRL–8110–9), 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 5E6903) by Valent U.S.A. Corporation, Walnut Creek, CA 94596-8025. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the fungicide fluopicolide, 2,6-dichloroN-[[3-chloro-5-(trifluoromethyl)-2pyridinyl]methyl] benzamide, in or on imported grape, juice, and grape, wine at 2.0 ppm and the processed commodity grape, raisin at 9.0 ppm. That notice referenced a summary of the petition prepared by Valent U.S.A. Corporation, the registrant, which is available to the public in the docket, https://www.regulations.gov. Comments were received on the notice of filing. EPA’s response to these comments are discussed in Unit IV.C. 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 https:// www.epa.gov/fedrgstr/EPA-PEST/1997/ November/Day-26/p30948.htm. PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 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 residues of fluopicolide in or on grape at 2.0 ppm and grape, raisin at 6.0 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 fluopicolide as well as the no-observedadverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov. The referenced document is available in docket ID EPA–HQ–OPP–2006–0481. 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 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 E:\FR\FM\28MRR1.SGM 28MRR1 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Rules and Regulations pwalker on PROD1PC71 with RULES principles EPA uses in risk characterization at https://www.epa.gov/ pesticides/factsheets/riskassess.htm and https://www.epa.gov/oppfead1/trac/ science. A summary of the toxicological endpoints for fluopicolide used for human risk assessment can be found at https://www.regulations.gov. The referenced document is available in docket ID EPA–HQ–OPP–2006–0481. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have not been established (40 CFR 180.627) for the residues of fluopicolide, in or imported grapes. There are no registrations for use of fluopicolide in the United States. There are no major livestock feed items associated with the use on imported grapes. Therefore, residues in livestock commodities are not relevant to the establishment of import tolerances for grapes. Risk assessments were conducted by EPA to assess dietary exposures from fluopicolide 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 one-day or single exposure. No acute reference dose was established nor was a dietary endpoint identified in either the general population or for females aged 13-49 years. There were no appropriate studies that demonstrated evidence of toxicity attributable to a single dose of fluopicolide for these populations. As a result, 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 dietary assessment included grape commodities, as the only source of residues for fluopicolide. It was assumed that 100% of all grape commodities contained tolerance level residues. iii. Cancer. Fluopicolide is not likely to be carcinogenic to humans; therefore, a cancer exposure assessment was not conducted. iv. Anticipated residue and percent crop treated (PCT) information. VerDate Aug<31>2005 16:03 Mar 27, 2007 Jkt 211001 Anticipated residues/PCT data were not needed to refine the risk assessment so they were not used. 2. Dietary exposure from drinking water. Since there are no existing U.S. registrations for fluopicolide, no residues from fluopicolide are expected to occur in drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). No occupational exporue to fluopicolide is expected to occur in the U.S. as a result of fluopicolide on imported grapes. 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 fluopicolide and any other substances and fluopicolide 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 fluopicolide 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 https:// 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 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 14445 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. Acceptable/guideline studies for developmental toxicity in rats and rabbits as well as a 2-generation reproduction study in rats were available for consideration during endpoint selection. There is no evidence of susceptibility following in utero and/ or postnatal exposure in the rabbit developmental toxicity study or in the 2-generation rat reproduction study. Although qualitative susceptibility was observed in the rat developmental toxicity study, there is low concern for these effects because the offspring effects (reduced growth and skeletal defects) are well characterized and accompanied by maternal toxicity. There are no residual uncertainties concerning pre- and post-natal toxicity. 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: There is a complete toxicity database for fluopicolide. There are no residual uncertainties concerning preand post-natal toxicity and no neurotoxicity concerns. The dietary food exposure assessment utilizes tolerance level residues and 100% CT. There is no potential for drinking water exposure. There is no potential for residential exposure. E. Aggregate Risks and Determination of Safety In accordance with the FQPA, EPA must consider and aggregate pesticide exposures and risks from three major sources: Food, drinking water, and residential exposures. In an aggregate assessment, exposures from relevant sources are added together and compared to quantitative estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated. When aggregating exposures and risks from various sources, EPA considers both the route and duration of exposure.The registrant is seeking import tolerances on grapes and its processed commodities and the risk assessment includes only dietary E:\FR\FM\28MRR1.SGM 28MRR1 14446 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Rules and Regulations pwalker on PROD1PC71 with RULES exposure to fluopicolide. There is no expectation that exposure to fluopicolide would occur via water consumption or residential use. Therefore, an aggregate exposure risk assessment is equivalent to the dietary risk assessment. 1. Acute risk. Because there was no evidence of toxicity for fluopicolide attributable to a single dose, fluopicolide is not expected to pose an acute risk. 2. Chronic risk. As there are no U.S. registrations or proposed registrations, the chronic aggregate risk is equivalent to the chronic dietary risk for fluopicolide residues in food. The chronic dietary exposure estimates are <1% cPAD for the general U.S. population and 3% cPAD for children 12 years old, the most highly exposed subgroup. The dietary risk estimates are all below EPA’s level of concern. 3. Short-term risk. Short–term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). As there are no U.S. registrations or proposed registrations for fluopicolide, there will be no exposures from residential uses or residues in drinking water. Therefore, the aggregate risk is the risk from food (grape commodities) only. The dietary risk estimates are all below EPA’s level of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). As there are no U.S. registrations or proposed registrations for fluopicolide, there will be no exposures from residential uses or residues in drinking water. Therefore, the aggregate risk is the risk from food (grape commodities) only. The dietary risk estimates are all below EPA’s level of concern. 5. Aggregate cancer risk for U.S. population. Fluopicolide is not likely to be carcinogenic to humans; therefore, fluopicolide is not expected to pose a cancer risk. 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 fluopicolide residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology liquid chromatography/mass spectrometry/mass spectrometry (LC/ VerDate Aug<31>2005 16:03 Mar 27, 2007 Jkt 211001 MS/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 No Codex, Canadian, or Mexican maximum residue limits (MRLs) or tolerances have been established for fluopicolide. C. Response to Coments One comment dated June 14, 2006, was received from B. Sachau. Ms. Sachau’s comments regarding general exposure to pesticides contained no scientific data or evidence to rebut the Agency’s conclusion that there is a reasonable certainty that no harm will result from aggregate exposure to fluopicolide, including all anticipated dietary exposures and other exposures for which there is reliable information. This comment as well as her comments regarding animal testing have been responded to by the Agency on several occasions. For examples, see the Federal Register issues of January 7, 2005 (70 FR 1349) (FRL–7691–4) and October 29, 2004 (69 FR 63083) (FRL– 7681–9). V. Conclusion Therefore, the tolerance is established for residues of fluopicolide, 2,6dichloro-N-[[3-chloro-5(trifluoromethyl)-2pyridinyl]methyl]benzamide, in or on grape at a tolerance level of 2.0 parts per million (ppm), and grape, raisin at a tolerance level of 6.0 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 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 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 E:\FR\FM\28MRR1.SGM 28MRR1 Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Rules and Regulations 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. § 180.627 residues. VII. Congressional Review Act Federal Emergency Management Agency 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: March 21, 2007. Steven Bradbury, Acting Director, Office of Pesticides Program. Therefore, 40 CFR chapter I is amended as follows: I pwalker on PROD1PC71 with RULES 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 180.627 is added to subpart C to read as follows: VerDate Aug<31>2005 16:03 Mar 27, 2007 Jkt 211001 (a) General. Tolerances are established for residues of fluopicolide, 2,6-dichloro-N-[[3-chloro-5(trifluoromethyl)-2-pyridinyl]methyl] benzamide, in or on the following commodities. Commodity Parts per million Grape ................................ Grape, raisin ..................... 2.0 6.0 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. E7–5628 Filed 3–27–07; 8:45 am] BILLING CODE 6560–50–S DEPARTMENT OF HOMELAND SECURITY 44 CFR Part 65 Changes in Flood Elevation Determinations Federal Emergency Management Agency, DHS. ACTION: Final rule. AGENCY: SUMMARY: Modified Base (1% annualchance) Flood Elevations (BFEs) are finalized for the communities listed below. These modified BFEs will be used to calculate flood insurance premium rates for new buildings and their contents. DATES: The effective dates for these modified BFEs are indicated on the following table and revise the Flood Insurance Rate Maps (FIRMs) in effect for the listed communities prior to this date. ADDRESSES: The modified BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below. FOR FURTHER INFORMATION CONTACT: PART 180—[AMENDED] I Fluopicolide; tolerances for William R. Blanton, Jr., Engineering Management Section, Mitigation Division, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3151. SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency (FEMA) makes the final determinations listed below of the modified BFEs for PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 14447 each community listed. These modified BFEs have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA resolved any appeals resulting from this notification. The modified BFEs are not listed for each community in this notice. However, this final rule includes the address of the Chief Executive Officer of the community where the modified BFEs determinations are available for inspection. The modified BFEs are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65. For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals. The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP). These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities. These modified BFEs are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings. The changes in BFEs are in accordance with 44 CFR 65.4. National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601–612, a regulatory flexibility analysis is not required. Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, E:\FR\FM\28MRR1.SGM 28MRR1

Agencies

[Federal Register Volume 72, Number 59 (Wednesday, March 28, 2007)]
[Rules and Regulations]
[Pages 14443-14447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5628]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-481; FRL-8120-1]


Fluopicolide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluopicolide in or on imported grape at 2.0 parts per million (ppm), 
and grape, raisin at 6.0 ppm with no U.S. registration. Bayer 
CropScience AG requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of 1996 (FQPA). The tolerance petition and data was transferred to 
Valent U.S.A. Corporation on January 9, 2006.

DATES: This regulation is effective March 28, 2007. Objections and 
requests for hearings must be received on or before May 29, 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-2006-0481. 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 https://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6129; e-mail address: 
janet.whitehurst@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 code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather 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

[[Page 14444]]

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 https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://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 https://
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-2006-0481 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 May 29, 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-2006-0481, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of January 24, 2007 (72 FR 3132) (FRL-8110-
9), 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 
5E6903) by Valent U.S.A. Corporation, Walnut Creek, CA 94596-8025. The 
petition requested that 40 CFR part 180 be amended by establishing a 
tolerance for residues of the fungicide fluopicolide, 2,6-dichloro-N-
[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl] benzamide, in or on 
imported grape, juice, and grape, wine at 2.0 ppm and the processed 
commodity grape, raisin at 9.0 ppm. That notice referenced a summary of 
the petition prepared by Valent U.S.A. Corporation, the registrant, 
which is available to the public in the docket, https://
www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments are discussed in Unit IV.C.
    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 https://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 residues of fluopicolide in or 
on grape at 2.0 ppm and grape, raisin at 6.0 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 fluopicolide 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 https://
www.regulations.gov. The referenced document is available in docket ID 
EPA-HQ-OPP-2006-0481.

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

[[Page 14445]]

principles EPA uses in risk characterization at https://www.epa.gov/
pesticides/factsheets/riskassess.htm and https://www.epa.gov/oppfead1/
trac/science.
    A summary of the toxicological endpoints for fluopicolide used for 
human risk assessment can be found at https://www.regulations.gov. The 
referenced document is available in docket ID EPA-HQ-OPP-2006-0481.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have not 
been established (40 CFR 180.627) for the residues of fluopicolide, in 
or imported grapes. There are no registrations for use of fluopicolide 
in the United States. There are no major livestock feed items 
associated with the use on imported grapes. Therefore, residues in 
livestock commodities are not relevant to the establishment of import 
tolerances for grapes. Risk assessments were conducted by EPA to assess 
dietary exposures from fluopicolide 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 one-day or single exposure.
    No acute reference dose was established nor was a dietary endpoint 
identified in either the general population or for females aged 13-49 
years. There were no appropriate studies that demonstrated evidence of 
toxicity attributable to a single dose of fluopicolide for these 
populations. As a result, 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 dietary assessment included grape commodities, as the only source 
of residues for fluopicolide. It was assumed that 100% of all grape 
commodities contained tolerance level residues.
    iii. Cancer. Fluopicolide is not likely to be carcinogenic to 
humans; therefore, a cancer exposure assessment was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Anticipated residues/PCT data were not needed to refine the risk 
assessment so they were not used.
    2. Dietary exposure from drinking water. Since there are no 
existing U.S. registrations for fluopicolide, no residues from 
fluopicolide are expected to occur in drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). No occupational 
exporue to fluopicolide is expected to occur in the U.S. as a result of 
fluopicolide on imported grapes.
    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 fluopicolide and any other 
substances and fluopicolide 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 fluopicolide 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 https://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. Acceptable/guideline studies 
for developmental toxicity in rats and rabbits as well as a 2-
generation reproduction study in rats were available for consideration 
during endpoint selection. There is no evidence of susceptibility 
following in utero and/or postnatal exposure in the rabbit 
developmental toxicity study or in the 2-generation rat reproduction 
study. Although qualitative susceptibility was observed in the rat 
developmental toxicity study, there is low concern for these effects 
because the offspring effects (reduced growth and skeletal defects) are 
well characterized and accompanied by maternal toxicity. There are no 
residual uncertainties concerning pre- and post-natal toxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings: There is a 
complete toxicity database for fluopicolide. There are no residual 
uncertainties concerning pre- and post-natal toxicity and no 
neurotoxicity concerns. The dietary food exposure assessment utilizes 
tolerance level residues and 100% CT. There is no potential for 
drinking water exposure. There is no potential for residential 
exposure.

E. Aggregate Risks and Determination of Safety

    In accordance with the FQPA, EPA must consider and aggregate 
pesticide exposures and risks from three major sources: Food, drinking 
water, and residential exposures. In an aggregate assessment, exposures 
from relevant sources are added together and compared to quantitative 
estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can 
be aggregated. When aggregating exposures and risks from various 
sources, EPA considers both the route and duration of exposure.The 
registrant is seeking import tolerances on grapes and its processed 
commodities and the risk assessment includes only dietary

[[Page 14446]]

exposure to fluopicolide. There is no expectation that exposure to 
fluopicolide would occur via water consumption or residential use. 
Therefore, an aggregate exposure risk assessment is equivalent to the 
dietary risk assessment.
    1. Acute risk. Because there was no evidence of toxicity for 
fluopicolide attributable to a single dose, fluopicolide is not 
expected to pose an acute risk.
    2. Chronic risk. As there are no U.S. registrations or proposed 
registrations, the chronic aggregate risk is equivalent to the chronic 
dietary risk for fluopicolide residues in food. The chronic dietary 
exposure estimates are <1% cPAD for the general U.S. population and 3% 
cPAD for children 1-2 years old, the most highly exposed subgroup. The 
dietary risk estimates are all below EPA's level of concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). As there are no U.S. 
registrations or proposed registrations for fluopicolide, there will be 
no exposures from residential uses or residues in drinking water. 
Therefore, the aggregate risk is the risk from food (grape commodities) 
only. The dietary risk estimates are all below EPA's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). As there are 
no U.S. registrations or proposed registrations for fluopicolide, there 
will be no exposures from residential uses or residues in drinking 
water. Therefore, the aggregate risk is the risk from food (grape 
commodities) only. The dietary risk estimates are all below EPA's level 
of concern.
    5. Aggregate cancer risk for U.S. population. Fluopicolide is not 
likely to be carcinogenic to humans; therefore, fluopicolide is not 
expected to pose a cancer risk.
    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 fluopicolide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography/mass 
spectrometry/mass spectrometry (LC/MS/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

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) or 
tolerances have been established for fluopicolide.

C. Response to Coments

    One comment dated June 14, 2006, was received from B. Sachau. Ms. 
Sachau's comments regarding general exposure to pesticides contained no 
scientific data or evidence to rebut the Agency's conclusion that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to fluopicolide, including all anticipated dietary exposures 
and other exposures for which there is reliable information. This 
comment as well as her comments regarding animal testing have been 
responded to by the Agency on several occasions. For examples, see the 
Federal Register issues of January 7, 2005 (70 FR 1349) (FRL-7691-4) 
and October 29, 2004 (69 FR 63083) (FRL-7681-9).

V. Conclusion

    Therefore, the tolerance is established for residues of 
fluopicolide, 2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide, in or on grape at a tolerance level of 2.0 
parts per million (ppm), and grape, raisin at a tolerance level of 6.0 
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

[[Page 14447]]

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: March 21, 2007.
Steven Bradbury,
Acting Director, Office of Pesticides Program.

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 180.627 is added to subpart C to read as follows:


Sec.  180.627  Fluopicolide; tolerances for residues.

    (a) General. Tolerances are established for residues of 
fluopicolide, 2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl] benzamide, in or on the following commodities.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Grape.....................................  2.0
Grape, raisin.............................  6.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. E7-5628 Filed 3-27-07; 8:45 am]
BILLING CODE 6560-50-S
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