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Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8- dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide; Pesticide Tolerance
[Federal Register: July 25, 2007 (Volume 72, Number 142)] [Rules and Regulations] [Page 40759-40763] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25jy07-11] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0076; FRL-8137-7] Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8- dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a tolerance for combined residues or residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4] triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) in or on fish; fish, shellfish, mollusc; and fish, shellfish, crustacean. Dow AgroSciences LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 25, 2007. Objections and requests for hearings must be received on or before September 24, 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-2006-0076. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket Search.'' Insert the docket ID number where indicated and select the ``Submit'' button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805. FOR FURTHER INFORMATION CONTACT: Philip V. Errico, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 305-6663; e-mail address: errico.philip@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0076 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before September 24, 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 this copy, identified by docket ID number EPA-HQ-OPP-2006-0076, by one of the following methods: • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805. II. Petition for Tolerance In the Federal Register of April 14, 2006 (72 FR Page 19507) (FRL- 8063-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F7012) by Dow AgroSciences LLC, Dow AgroSciences [[Page 40760]] LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.605 be amended by establishing an exemption from tolerance for residues of the herbicide penoxsulam (2-(2,2- difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)- 6-(trifluoromethyl)benzenesulfonamide, in or on fish and shellfish resulting from its use as an aquatic herbicide. That notice referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available to the public in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV. below. The Registrant modified their submission and requested tolerances be established. The reason for these changes is explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of the 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 the 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 the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996. Consistent with section 408(b)(2)(D), of the FFDCA and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8- dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide) on fish, shellfish, mollusc; fish; and shellfish, crustacean at 0.02, 0.01, and 0.01 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 adverse effects caused by penoxsulam (2-(2,2-difluoroethoxy)-N- (5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide) as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of September 24, 2004 (EPA-HQ-OPP- 2004-0286), (FRL-7678-6). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long- term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm. A summary of the toxicological endpoints for penoxsulam (2-(2,2- difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)- 6-(trifluoromethyl)benzenesulfonamide) used for human risk assessment can be found at http://www.regulations.gov in document ``Penoxsulam. Human Health Risk Assessment for Proposed Uses on Fish and Shellfish. PC Code: 119031, Petition No: 5F7012, DP Num: 325461.'' at page 42 in Docket ID EPA-HQ-OPP-2006-0076. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8- dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide, EPA considered exposure under the petitioned-for tolerances as well as all existing penoxsulam (2-(2,2- difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)- 6-(trifluoromethyl)benzenesulfonamide) tolerances in (40 CFR 180.605). EPA assessed dietary exposures from penoxsulam (2-(2,2-difluoroethoxy)- N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide) 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5- c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998; Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to [[Page 40761]] residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. iii. Cancer. Penoxsulam was classified as ``Suggestive Evidence of Carcinogenic Potential.'' There is some cancer concern, but the data are judged not sufficient for a stronger conclusion or a quantitative cancer risk assessment (see Unit III.E.5). iv. Anticipated residue and percent crop treated (PCT) information. EPA assumed tolerance level residues and 100% of the crop is treated. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for penoxsulam (2-(2,2-difluoroethoxy)-N- (5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide) in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5- c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide). Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm. Based on the FQPA Index Reservoir Screening Tool and Screening Concentrations in Groundwater models, the estimated environmental concentrations (EECs) of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8- dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide) for acute exposures are estimated to be 150 parts per billion (ppb) for surface water and 150 ppb for ground water. The EECs for chronic exposures are estimated to be 150 ppb for surface water and 150 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 150 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 150 ppb was used to access the contribution to drinking water. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8- dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide) is currently registered for the following residential non-dietary sites: Turf/lawn. EPA assessed residential exposure using the following assumptions: • 1,000 ft2 per day by low pressure hand wand or back pack sprayer for spot treatment of lawns • 0.5 acres per day by push-type granular spreader for broadcast treatment of lawns • 0.06 lb active ingredient (ai) per acre for broadcast treatment • 0.0014 to 0.0016 lbs per 1,000 ft2 for spot treatment 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 penoxsulam (2-(2,2- difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)- 6-(trifluoromethyl)benzenesulfonamide) and any other substances and penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5- c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8- dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide) has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (``10X'') tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the 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. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. Based on the results of the submitted toxicology studies, EPA concluded that no FQPA safety factor is needed (i.e. 1X) since there are no residual uncertainties for prenatal and/or postnatal toxicity. 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. There was no toxicologically significant evidence observed of neurotoxicity in either the acute or chronic neurotoxicity study. ii. No definitive quantitative or qualitative susceptibility was observed in either of the developmental rat or rabbit studies. iii. Significant dose-related effects in the 2-generation reproduction study were limited to the delay in preputial separation. No other endpoints of reproductive toxicity or offspring growth and survival were affected by treatment. iv. The chronic dietary food exposure assessment utilizes proposed tolerance level residues and 100% crop treated for all commodities. By using these conservative assessments, actual and chronic exposures/ risks will not be underestimated. v. The dietary drinking water assessment (Tier 1 estimates) utilizes values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/ safety factors. [[Page 40762]] For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate, and long- term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. Acute risk. There were no treatment-related effects observed in any of the available toxicity studies on penoxsulam that could be considered to have resulted from a single dose of penoxsulam. Therefore no acute exposure is expected. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5- c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) for the most highly exposed population subgroup from food and water, which utilizes 7% of the cPAD is all infants (< 1 year old). 3. Short-term risk and intermediate term risk. For this aquatic use pattern, short- and intermediate-term aggregate exposure takes into account residential exposure, exposure while swimming, plus chronic exposure to food and water (considered being a background exposure level). There is a potential for post application exposure from oral and dermal routes of exposure while swimming in aquatic sites and/or from turf (lawns, golf courses, sports fields, and sod farms) sites treated with penoxsulam. EPA used the SWIMODEL from the Residential Standard Operating Procedures (SOPs) to assess dermal and oral exposure to recreational swimmers. Parameters used in calculating exposure and risk are based on information for competitive swimmers both adult and children (6 years old) in swimming pools which includes an exposure duration of 5 hours. It is anticipated that recreational swimmers in weed infested areas would be less likely to swim with their heads immersed than recreational swimmers in weed-free swimming pools. Since there were no short-term dermal, systemic, neuro or developmental toxicity concerns, the short-term post application assessment addresses only the oral exposure, which results in the same estimated dose for intermediate- term exposure. Thus a short-term aggregate exposure was not required, and the intermediate-term post application exposure assessment combined both oral and dermal exposures, and is also protective for short-term exposure. Short- and intermediate-term postapplication exposures resulted in MOEs> 100 and are therefore not a concern to the Agency. The Agency considers the swimmer dermal and oral MOEs to be over estimates of the actual risk, and therefore swimming exposure assessment was not used in assessing the short- and intermediate-term aggregate risk, and only the exposure resulting from the turf use was assessed. The short-term aggregate risk assessment estimates include both oral and inhalation exposures appropriate to the population of concern. Short-term dermal exposure was not aggregated because no toxicological endpoint was selected. For adults, short-term exposure to penoxsulam can occur as a result of the residential use on turf. Because oral exposure from the residential use as a handler is not expected in adults and no short-term dermal endpoint was selected, only the short- term residential exposure by inhalation is expected in adults. The worst-case MOE residential exposure estimate was aggregated with the chronic dietary (food + water) to provide a worst-case estimate of short-term aggregate risk for U.S. population. As the aggregate MOE is greater than 100, the short-term aggregate risk to adults does exceed EPA's level of concern. For children/toddlers, short-term exposure to penoxsulam can occur as a result of the residential use on turf. Because post-application inhalation exposure is negligible and no short-term dermal endpoint was selected, only short-term residential exposure from oral exposure was included with food and drinking water in the short-term aggregate risk assessment for children/toddlers. The worst-case MOE residential exposure estimate for children was aggregated with the chronic dietary (food + water) to provide a worst-case estimate of short-term aggregate risk for all infants (< 1 year old), the child population subgroup with the highest estimated chronic dietary food exposure. As the aggregate MOE is greater than 100, the short-term aggregate risks to children do not exceed EPA's level of concern. Because the amount of residues on turf after 30 days will be negligible, both inhalation and dermal exposure is negligible, and therefore no intermediate-term aggregate exposure assessment from this turf use is required. 4. Aggregate cancer risk for U.S. population. The cancer potential for penoxsulam is classified as ``Suggestive Evidence of Carcinogenic Potential.'' The classification is based on an increase in large granular lymphocyte leukemia (also called mononuclear cell leukemia (MNCL)) in male Fischer 344 rats. There were increased tumors at all dose levels which exceeded the laboratory historical control data. There is considerable controversy as to the significance and relevance of the tumors for humans, but they cannot be discounted in the overall weight of the evidence. While there is some cancer concern, the data are judged not sufficient for a stronger conclusion or a quantitative cancer risk assessment. 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, or to infants and children from aggregate exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8- dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6- (trifluoromethyl)benzenesulfonamide) residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, using high performance liquid chromatograph with tandem mass spectroscopy-mass spectroscopy detector (LC/MS/MS), and 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 maximum residue limits (MRLs) for fish; fish, shellfish, mollusc; and fish, shellfish, crustacean. C. Response to Comments Comments were received from a private citizen objecting to this product being used in the world, and that the product is too dangerous to be allowed use. A print-out of what appears to be EPA's summary of the toxicological effects and tolerances for rice were included. No other information was provided. EPA has found that there is a reasonable certainty of no harm to humans after considering all pertinent toxicology studies and the exposure levels of humans to penoxsulam. V. Conclusion Therefore, the tolerance is established for residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5- c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide, [[Page 40763]] in or on fish, shellfish, mollusc; fish; and shellfish, crustacean at 0.02, 0.01, and 0.01 ppm. The registrant initially requested exemptions from tolerances for fish and shellfish. Based upon review of the data supporting the petition by EPA and subsequent to completion of this risk assessment, the registrant revised their submission and requested tolerances for finfish at 0.01 ppm; shellfish, crustacean at 0.01 ppm; and shellfish, mollusc at 0.02 ppm. For consistency the commodity terms are revised to fish at 0.01 ppm; fish, shellfish, crustacean at 0.01 ppm; and fish, shellfish, mollusc at 0.02 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (59 FR 22951, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 13, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. • Therefore, 40 CFR chapter I is amended as follows: PART 180--AMENDED • 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. • 2. Section 180.605 is amended by alphabetically adding the following commodities to the table in paragraph (a) to read as follows: Sec. 180.605 Penoxsulam; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Fish....................................................... 0.01 Fish, shellfish, crustacean................................ 0.01 Fish, shellfish, mollusc................................... 0.02 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. E7-14335 Filed 7-24-07; 8:45 am] BILLING CODE 6560-50-S