Fluroxypyr; Pesticide Tolerance, 73631-73635 [E7-25092]

Download as PDF Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations Parts per million Commodity Rutabaga, roots ........................ Rutabaga, tops ......................... * * * * Turnip, greens .......................... Turnip, roots ............................. Turnip, tops ............................... * * * * 0.01 0.1 * 0.1 0.01 0.1 * (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. Tolerances with regional registration are established for residues of dimethenamid, 1 (R,S)-2-chloro-N-[(1methyl-2-methoxy) ethyl]-N-(2,4dimethylthien-3-yl)-acetamide) in or on the following raw agricultural commodities: Parts per million Commodity Pumpkin .................................... Squash, winter .......................... * * * * 0.01 0.01 * [FR Doc. E7–25090 Filed 12–27–07; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0114; FRL–8343–2] I. General Information Fluroxypyr; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. pwalker on PROD1PC71 with RULES AGENCY: SUMMARY: This regulation establishes tolerances for combined residues of fluroxypyr and its metabolite in or on pome fruit, group 11; millet (grain, forage, hay and proso millet straw). Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective December 28, 2007. Objections and requests for hearings must be received on or before February 26, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2007–0114. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–6463; e-mail address: madden.barbara@epa.gov. SUPPLEMENTARY 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 PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 73631 Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2007–0114 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 February 26, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– HQ–OPP–2007–0114, 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 E:\FR\FM\28DER1.SGM 28DER1 73632 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations 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. pwalker on PROD1PC71 with RULES II. Petition for Tolerance In the Federal Register of April 4, 2007 (72 FR 16352) (FRL–8119–2), 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 6E7168) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.535 be amended by establishing tolerances for combined residues of the herbicide fluroxypyr, 1-methylheptyl ester [1methylheptyl ((4-amino-3,5-dichloro-6fluoro-2-pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid], in or on pome, fruit, group 11 at 0.02 parts per million (ppm); millet, grain at 0.5 ppm; millet, forage at 12.0 ppm; millet, hay at 20.0 ppm; millet, proso, grain at 0.5 ppm; millet, proso, straw at 12.0 ppm; millet, proso, forage at 12.0 ppm; millet, proso, hay at 20.0 ppm; millet, pearl, grain at 0.5 ppm; millet, pearl, forage at 12.0 ppm; and millet, pearl, hay at 20.0 ppm. That notice referenced a summary of the petition prepared by Dow AgroSciences, the registrant, which is available to the public in the docket, http:// www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has determined that separate tolerances for proso and pearl millet grain, forage, and hay are not needed since these commodities are covered by the tolerances being established for millet grain, millet forage and millet hay. EPA is also deleting all the tolerances in § 180.535(b) for field and sweet corn, onion, and sorghum commodities that are no longer needed since they have expired. The deletions under § 180.535(b) are time-limited tolerances that were established under section 18 emergency exemptions that have since expired and have been superceded by the establishment of general tolerances for the same commodities under § 180.535(a). VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996. Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for combined residues of fluroxypyr, 1-methylheptyl ester [1methylheptyl ((4-amino-3,5-dichloro-6fluoro-2-pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] on fruit, pome, group 11 at 0.02 ppm; millet, grain at 0.5 ppm; millet, forage at 12.0 ppm; millet, hay at 20.0 ppm and millet, proso, straw at 12.0 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 adverse effects caused by fluroxypyr as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 level (LOAEL) from the toxicity studiescan be found at http:// www.regulations.gov in document Fluroxypyr: Human Health Risk Assessment to Support Proposed New Uses on Pome Fruits and Millet at Attachment #2 page 27 - 30 in docket ID number EPA–HQ–OPP–2007–0114. Fluroxypyr has low acute toxicity by the oral and dermal routes and moderate acute toxicity by the inhalation route. The kidney is the target organ for fluroxypyr following oral exposure to rats, mice, and dogs. In the rat, increased kidney weight and death were observed in both sexes in the 90–day feeding study, increased kidney weight and chronic progressive glomerulonephropathy were observed in both sexes in the chronic study. Increased kidney weight was observed in the maternal rat in the developmental toxicity study, and kidney effects (deaths due to renal failure; increased kidney weight, and microscopic kidney lesions) were observed in both sexes in the 2–generation reproduction study. Although kidney toxicity (early signs of acute tubular nephrosis) was observed in dogs in the 28–day feeding study, no kidney effects or other treatment related toxicity was seen in the chronic feeding study in dogs. Increased kidney lesions (increased incidences of renal papillary necrosis and regenerative nephrosis in females) were observed in mice following long-term exposure. Treatment related deaths were noted in maternal rats (600 milligrams/ kilograms/day (mg/kg/day)) and rabbits (400 mg/kg/day). Endpoints for risk assessment were based on kidney effects seen in the database. There was no evidence of increased susceptibility (quantitative/qualitative) following in utero exposure to the acid and the ester in rats and rabbits, or following prenatal and/or postnatal exposure in rats. There are no neurotoxicity concerns from the acute and subchronic neurotoxicity studies, and the weight of the evidence indicates a lack of concern for developmental neurotoxicity. Therefore, a developmental neurotoxicity study (DNT) is not required. Fluroxypyr is classified as ‘‘not likely’’ as a human carcinogen and there was no concern for its mutagenicity potential. 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 E:\FR\FM\28DER1.SGM 28DER1 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/ safety factors (UFs) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/fedrgstr/EPA-PEST/1997/ November/Day-26/p30948.htm. A summary of the toxicological endpoints for fluroxypyr used for human risk assessment can be found at http://www.regulations.gov in document Fluroxypyr: Human Health Risk Assessment to Support Proposed New Uses on Pome Fruits and Millet at page 11 in docket ID number EPA–HQ–OPP– 2007–0114. pwalker on PROD1PC71 with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluroxypyr, EPA considered exposure from the petitioned-for tolerances as well as all existing fluroxypyr tolerances in (40 CFR 180.535). EPA assessed dietary exposures from fluroxypyr 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 single exposure. No such effects were identified in the toxicological studies for fluroxypyr; therefore, a quantitative acute dietary exposure assessment is unnecessary. VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 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 residue levels in food, assumed all foods for which there are tolerances were treated and contain tolerance-level residues. iii. Cancer. Based on the results of carcinogenicity studies in rats and mice, EPA has concluded that fluroxypyr is ‘‘not likely to be carcinogenic to humans.’’ Consequently, a quantitative cancer exposure and risk assessment is not appropriate for fluroxypyr. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for fluroxypyr 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 fluroxypyr. 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 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCIGROW) models, the estimated environmental concentrations (EECs) of fluroxypyr for chronic exposures are estimated to be 3.28 ppb for surface water and 0.04 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 3.28 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fluroxypyr is currently registered for the following residential non-dietary sites: Application to residential turf grass and recreational sites such as golf courses, parks, and sports fields. EPA assessed residential exposure using the following assumptions: Residential handlers may receive short-term dermal and inhalation exposure to fluroxypyr when mixing, loading and applying the formulations. However, toxicity by the dermal route of PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 73633 exposure is not expected; therefore only inhalation daily doses for residential handlers were calculated. Adults and children may be exposed to fluroxypyr residues from dermal contact with turf during post-application activities. Toddlers may receive short- and intermediate-term oral exposure from incidental ingestion during postapplication activities. A dermal risk assessment for post-application exposures was not conducted because a dermal endpoint was not selected. Therefore, only the following postapplication exposure scenarios resulting from lawn treatment were assessed: i. Toddlers’ incidental ingestion of pesticide residues on lawns from handto-mouth transfer, ii. Object-to-mouth transfer from mouthing of pesticide-treated turfgrass, and iii. Incidental ingestion of soil from pesticide-treated residential areas. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fluroxypyr and any other substances and fluroxypyr 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 fluroxypyr has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (‘‘10X’’) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the E:\FR\FM\28DER1.SGM 28DER1 73634 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. There was no evidence of increased susceptibility (quantitative/qualitative) following in utero exposure to the fluroxypyr in rats and rabbits, or following prenatal and/or postnatal exposure in rats. There are no neurotoxicity concerns from the acute and subchronic neurotoxicity studies, and the weight of the evidence indicates a lack of concern for developmental neurotoxicity. 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for fluroxypyr is complete. ii. There is no indication that fluroxypyr is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that fluroxypyr results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2–generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% crop treated and tolerance-level residues. Conservative ground and surface water modeling estimates were used. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluroxypyr. pwalker on PROD1PC71 with RULES E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 by the product of all applicable UFs is not exceeded. 1. Acute risk. None of the toxicology studies available for fluroxypyr indicated the possibility of an effect of concern occurring as a result of a single exposure; therefore, fluroxypyr is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fluroxypyr from food and water will utilize 1.4% of the cPAD for children 1-2 years old, the subpopulation group with greatest exposure. Based on the use patterns, chronic residential exposure to residues of fluroxypyr is not expected. 3. Short-term risk and intermediateterm. Short-term and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluroxypyr is currently registered for uses that could result in short-term and intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for fluroxypyr. Using the exposure assumptions described in this unit for short-term and intermediate-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of 4,400 to 53,000. The MOE for the U.S. population is 8,200. The most highly exposed subgroup was Children, 1-2 years old, with an MOE of 4,400. 4. Aggregate cancer risk for U.S. population. There was no evidence of carcinogenicity in two carcinogenicity studies in rats and mice with fluroxypyr. Therefore, fluroxypyr is considered ‘‘Not likely to be carcinogenic to humans.’’ Fluroxypyr is not expected to pose a cancer risk. 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 fluroxypyr residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography/mass-selective detector (GC/MSD)) 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; email address: residuemethods@epa.gov. PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 B. International Residue Limits There are no Codex, Canadian or Mexican MRLs for fluroxypyr for pome fruits or millet. V. Conclusion Therefore, tolerances are established for combined residues of fluroxypyr, 1methylheptyl ester [1-methylheptyl ((4amino-3,5-dichloro-6-fluoro-2pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6fluoro-2-pyridinyl)oxy)acetic acid] in or on fruit, pome, group 11 at 0.02 ppm; millet, grain at 0.5 ppm; millet, forage at 12.0 ppm; millet, hay at 20.0 ppm and millet, proso, straw at 12.0 ppm. Time-limited tolerances were established in 40 CFR 180.535(b) for residues of fluroxypyr on field and sweet corn, onion, and sorghum commodities in connection with FIFRA section 18 emergency exemptions granted by the EPA. All of these timelimited tolerances have expired and are no longer in force. Permanent tolerances have been established on these commodities in § 180.535(a). Because expired, time-limited tolerances for residues of fluroxypyr are without effect, this final rule removes them from EPA’s regulations. EPA finds there is good cause to make this latter change without prior notice and comment because it eliminates obsolete portions of the regulation. EPA concludes notice and comment are unnecessary on such changes. 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 E:\FR\FM\28DER1.SGM 28DER1 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). pwalker on PROD1PC71 with RULES VII. Congressional Review Act 23:53 Dec 27, 2007 Jkt 214001 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 14, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.535 is amended by alphabetically adding the following commodities to the table in paragraph (a), removing the expired time-limited tolerances in paragraph (b), and reserving it to read as follows: I § 180.535 Fluroxypyr 1-methylheptyl ester; tolerances for residues. (a) * * * * * Parts per million * Fruit, pome, group 11 ............... * * * * Millet, Millet, Millet, Millet, * forage ............................. grain ............................... hay ................................. proso, straw ................... * * * * 0.02 * 12.0 0.5 20.0 12.0 * (b) Section 18 emergency exemptions. [Reserved] * * * * * BILLING CODE 6560–50–S PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 42 CFR Parts 431, 433, and 440 Medicaid Program; Elimination of Reimbursement Under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School Therefore, 40 CFR chapter I is amended as follows: * Centers for Medicare & Medicaid Services RIN 0938–AP13 I Commodity DEPARTMENT OF HEALTH AND HUMAN SERVICES [CMS–2287–F] [FR Doc. E7–25092 Filed 12–27–07; 8:45 am] 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). VerDate Aug<31>2005 List of Subjects in 40 CFR Part 180 73635 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. AGENCY: SUMMARY: Under the Medicaid program, Federal payment is available for the costs of administrative activities ‘‘as found necessary by the Secretary for the proper and efficient administration of the State plan.’’ This final rule eliminates Federal Medicaid payment for the costs of certain school-based administrative and transportation activities because the Secretary has found that these activities are not necessary for the proper and efficient administration of the Medicaid State plan and are not within the definition of the optional transportation benefit. Based on these determinations, under this final rule, Federal Medicaid payments will no longer be available for administrative activities performed by school employees or contractors, or anyone under the control of a public or private educational institution, and for transportation from home to school. In addition, this final rule responds to public comments received on the September 7, 2007 proposed rule. EFFECTIVE DATE: These regulations are effective on February 26, 2008. FOR FURTHER INFORMATION CONTACT: Sharon J. Brown, (410) 786–0673, Judi Wallace, (410) 786–3197. SUPPLEMENTARY INFORMATION: We published a proposed rule in the Federal Register on September 7, 2007, at 72 FR 51397 that would eliminate Federal Medicaid payment for schoolbased administrative activities, based on a Secretarial finding that such activities are not necessary for the proper and efficient administration of the Medicaid State plan. Moreover, the proposed rule would also eliminate Federal Medicaid payment based on a finding that transportation from home to school and back for school-age children is neither necessary for the proper and efficient administration of the Medicaid State E:\FR\FM\28DER1.SGM 28DER1

Agencies

[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Rules and Regulations]
[Pages 73631-73635]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25092]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0114; FRL-8343-2]


Fluroxypyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of fluroxypyr and its metabolite in or on pome fruit, group 11; millet 
(grain, forage, hay and proso millet straw). Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 28, 2007. Objections and 
requests for hearings must be received on or before February 26, 2008, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0114. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@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 FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0114 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 February 26, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0114, 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

[[Page 73632]]

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 4, 2007 (72 FR 16352) (FRL-8119-
2), 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 
6E7168) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested 
that 40 CFR 180.535 be amended by establishing tolerances for combined 
residues of the herbicide fluroxypyr, 1-methylheptyl ester [1-
methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] 
and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy)acetic acid], in or on pome, fruit, group 11 at 0.02 
parts per million (ppm); millet, grain at 0.5 ppm; millet, forage at 
12.0 ppm; millet, hay at 20.0 ppm; millet, proso, grain at 0.5 ppm; 
millet, proso, straw at 12.0 ppm; millet, proso, forage at 12.0 ppm; 
millet, proso, hay at 20.0 ppm; millet, pearl, grain at 0.5 ppm; 
millet, pearl, forage at 12.0 ppm; and millet, pearl, hay at 20.0 ppm. 
That notice referenced a summary of the petition prepared by Dow 
AgroSciences, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that separate tolerances for proso and pearl millet grain, 
forage, and hay are not needed since these commodities are covered by 
the tolerances being established for millet grain, millet forage and 
millet hay.
    EPA is also deleting all the tolerances in Sec.  180.535(b) for 
field and sweet corn, onion, and sorghum commodities that are no longer 
needed since they have expired. The deletions under Sec.  180.535(b) 
are time-limited tolerances that were established under section 18 
emergency exemptions that have since expired and have been superceded 
by the establishment of general tolerances for the same commodities 
under Sec.  180.535(a).

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerance for combined residues of fluroxypyr, 1-methylheptyl ester [1-
methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate] 
and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy)acetic acid] on fruit, pome, group 11 at 0.02 ppm; 
millet, grain at 0.5 ppm; millet, forage at 12.0 ppm; millet, hay at 
20.0 ppm and millet, proso, straw at 12.0 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 adverse effects caused by fluroxypyr as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studiescan be found at http://
www.regulations.gov in document Fluroxypyr: Human Health Risk 
Assessment to Support Proposed New Uses on Pome Fruits and Millet at 
Attachment 2 page 27 - 30 in docket ID number EPA-HQ-OPP-2007-
0114.
    Fluroxypyr has low acute toxicity by the oral and dermal routes and 
moderate acute toxicity by the inhalation route. The kidney is the 
target organ for fluroxypyr following oral exposure to rats, mice, and 
dogs. In the rat, increased kidney weight and death were observed in 
both sexes in the 90-day feeding study, increased kidney weight and 
chronic progressive glomerulonephropathy were observed in both sexes in 
the chronic study. Increased kidney weight was observed in the maternal 
rat in the developmental toxicity study, and kidney effects (deaths due 
to renal failure; increased kidney weight, and microscopic kidney 
lesions) were observed in both sexes in the 2-generation reproduction 
study. Although kidney toxicity (early signs of acute tubular 
nephrosis) was observed in dogs in the 28-day feeding study, no kidney 
effects or other treatment related toxicity was seen in the chronic 
feeding study in dogs. Increased kidney lesions (increased incidences 
of renal papillary necrosis and regenerative nephrosis in females) were 
observed in mice following long-term exposure. Treatment related deaths 
were noted in maternal rats (600 milligrams/kilograms/day (mg/kg/day)) 
and rabbits (400 mg/kg/day). Endpoints for risk assessment were based 
on kidney effects seen in the database. There was no evidence of 
increased susceptibility (quantitative/qualitative) following in utero 
exposure to the acid and the ester in rats and rabbits, or following 
prenatal and/or postnatal exposure in rats. There are no neurotoxicity 
concerns from the acute and subchronic neurotoxicity studies, and the 
weight of the evidence indicates a lack of concern for developmental 
neurotoxicity. Therefore, a developmental neurotoxicity study (DNT) is 
not required. Fluroxypyr is classified as ``not likely'' as a human 
carcinogen and there was no concern for its mutagenicity potential.

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

[[Page 73633]]

at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for fluroxypyr used for 
human risk assessment can be found at http://www.regulations.gov in 
document Fluroxypyr: Human Health Risk Assessment to Support Proposed 
New Uses on Pome Fruits and Millet at page 11 in docket ID number EPA-
HQ-OPP-2007-0114.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluroxypyr, EPA considered exposure from the petitioned-for 
tolerances as well as all existing fluroxypyr tolerances in (40 CFR 
180.535). EPA assessed dietary exposures from fluroxypyr 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 single exposure.
    No such effects were identified in the toxicological studies for 
fluroxypyr; 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 residue levels in food, assumed all foods for which 
there are tolerances were treated and contain tolerance-level residues.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA has concluded that fluroxypyr is ``not likely to be 
carcinogenic to humans.'' Consequently, a quantitative cancer exposure 
and risk assessment is not appropriate for fluroxypyr.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for fluroxypyr 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 
fluroxypyr. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
fluroxypyr for chronic exposures are estimated to be 3.28 ppb for 
surface water and 0.04 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration value of 3.28 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fluroxypyr is currently registered for the following residential 
non-dietary sites: Application to residential turf grass and 
recreational sites such as golf courses, parks, and sports fields. EPA 
assessed residential exposure using the following assumptions:
    Residential handlers may receive short-term dermal and inhalation 
exposure to fluroxypyr when mixing, loading and applying the 
formulations. However, toxicity by the dermal route of exposure is not 
expected; therefore only inhalation daily doses for residential 
handlers were calculated. Adults and children may be exposed to 
fluroxypyr residues from dermal contact with turf during post-
application activities. Toddlers may receive short- and intermediate-
term oral exposure from incidental ingestion during post-application 
activities. A dermal risk assessment for post-application exposures was 
not conducted because a dermal endpoint was not selected. Therefore, 
only the following post-application exposure scenarios resulting from 
lawn treatment were assessed:
    i. Toddlers' incidental ingestion of pesticide residues on lawns 
from hand-to-mouth transfer,
    ii. Object-to-mouth transfer from mouthing of pesticide-treated 
turfgrass, and
    iii. Incidental ingestion of soil from pesticide-treated 
residential areas.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to fluroxypyr and any other 
substances and fluroxypyr 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 fluroxypyr has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the

[[Page 73634]]

FQPA safety factor. In applying this provision, EPA either retains the 
default value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional FQPA safety factor value based on the use of 
traditional UFs and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility (quantitative/qualitative) following in utero 
exposure to the fluroxypyr in rats and rabbits, or following prenatal 
and/or postnatal exposure in rats. There are no neurotoxicity concerns 
from the acute and subchronic neurotoxicity studies, and the weight of 
the evidence indicates a lack of concern for developmental 
neurotoxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for fluroxypyr is complete.
    ii. There is no indication that fluroxypyr is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluroxypyr results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated and tolerance-level residues. Conservative ground 
and surface water modeling estimates were used. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
fluroxypyr.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. None of the toxicology studies available for 
fluroxypyr indicated the possibility of an effect of concern occurring 
as a result of a single exposure; therefore, fluroxypyr is not expected 
to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fluroxypyr from food and water will utilize 1.4% of the cPAD for 
children 1-2 years old, the subpopulation group with greatest exposure. 
Based on the use patterns, chronic residential exposure to residues of 
fluroxypyr is not expected.
    3. Short-term risk and intermediate-term. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Fluroxypyr is currently registered for uses that could result in 
short-term and intermediate-term residential exposure and the Agency 
has determined that it is appropriate to aggregate chronic food and 
water and short-term exposures for fluroxypyr.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food, 
water, and residential exposures aggregated result in aggregate MOEs of 
4,400 to 53,000. The MOE for the U.S. population is 8,200. The most 
highly exposed subgroup was Children, 1-2 years old, with an MOE of 
4,400.
    4. Aggregate cancer risk for U.S. population. There was no evidence 
of carcinogenicity in two carcinogenicity studies in rats and mice with 
fluroxypyr. Therefore, fluroxypyr is considered ``Not likely to be 
carcinogenic to humans.'' Fluroxypyr is not expected to pose a cancer 
risk.
    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 fluroxypyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    There are no Codex, Canadian or Mexican MRLs for fluroxypyr for 
pome fruits or millet.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
fluroxypyr, 1-methylheptyl ester [1-methylheptyl ((4-amino-3,5-
dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite 
fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic 
acid] in or on fruit, pome, group 11 at 0.02 ppm; millet, grain at 0.5 
ppm; millet, forage at 12.0 ppm; millet, hay at 20.0 ppm and millet, 
proso, straw at 12.0 ppm.
    Time-limited tolerances were established in 40 CFR 180.535(b) for 
residues of fluroxypyr on field and sweet corn, onion, and sorghum 
commodities in connection with FIFRA section 18 emergency exemptions 
granted by the EPA. All of these time-limited tolerances have expired 
and are no longer in force. Permanent tolerances have been established 
on these commodities in Sec.  180.535(a). Because expired, time-limited 
tolerances for residues of fluroxypyr are without effect, this final 
rule removes them from EPA's regulations. EPA finds there is good cause 
to make this latter change without prior notice and comment because it 
eliminates obsolete portions of the regulation. EPA concludes notice 
and comment are unnecessary on such changes.

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

[[Page 73635]]

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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


0
2. Section 180.535 is amended by alphabetically adding the following 
commodities to the table in paragraph (a), removing the expired time-
limited tolerances in paragraph (b), and reserving it to read as 
follows:


Sec.  180.535  Fluroxypyr 1-methylheptyl ester; tolerances for 
residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Fruit, pome, group 11......................................         0.02
                                * * * * *
Millet, forage.............................................         12.0
Millet, grain..............................................          0.5
Millet, hay................................................         20.0
Millet, proso, straw.......................................         12.0
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E7-25092 Filed 12-27-07; 8:45 am]
BILLING CODE 6560-50-S