Dimethenamid; Pesticide Tolerance, 73626-73631 [E7-25090]

Download as PDF 73626 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations This correction is effective December 28, 2007. DATES: Ms. Lula Melton, Air Quality Assessment Division (C304–02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541– 2910; fax number: (919) 541–4511; email address melton.lula@epa.gov. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background The EPA issued a final rule on August 27, 2007 (72 FR 48938) that allows source owners or operators, in the event of a force majeure, to petition the Administrator for an extension of the deadline(s) by which they are required to conduct a performance test required by the Consolidated Federal Air Rule. A ‘‘force majeure’’ is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents the owner or operator from complying with the regulatory requirement to conduct performance tests within the specified timeframe, despite the affected facility’s best efforts to fulfill the obligation. Examples of such events are acts of nature, acts of war or terrorism, or equipment failure or safety hazard beyond the control of the affected facility. pwalker on PROD1PC71 with RULES II. Summary of Amendment The EPA promulgated revisions to the General Provisions for Consolidated Federal Air Rule on August 27, 2007. Afterwards, we realized that we inadvertently stated that we were revising paragraph (c) introductory text when we actually added introductory text to paragraph (c). The purpose of this action is to correct this error. III. Statutory and Executive Order Reviews Under Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a ‘‘significant regulatory action’’ and is, therefore, not subject to review by the Office of Management and Budget (OMB). This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). The technical correction does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Because EPA has made a ‘‘good cause’’ finding that this action is not subject to notice and comment requirements under the APA or any other statute, it is not subject to the regulatory flexibility provisions of the VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA)(Pub. L. 104–4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of the UMRA. The correction does not have a substantial direct effect on the States, or on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of Government, as specified in Executive Order 13132, Federalism (64 FR 43255, August 10, 1999). Today’s action also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13175, Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000). The technical correction also is not subject to Executive Order 13045, Protection of Children from Environmental Health and Safety Risks (62 FR 19885, April 23, 1997) because this action is not economically significant. The correction is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because this action is not a significant regulatory action under Executive Order 12866. The correction does not involve changes to the technical standards related to test methods or monitoring requirements; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply. The correction also does not involve special consideration of environmental justice-related issues as required by Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the U.S. The EPA will submit a report containing this final action and other required information to the U.S. Senate, the U.S. House of Representatives, and PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 the Comptroller General of the U.S. prior to publication of today’s action in the Federal Register. Today’s action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). The final rule will be effective December 28, 2007. List of Subjects in 40 CFR Part 65 Air pollution control, Environmental protection, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: December 20, 2007. Robert J. Meyers, Principal Deputy Assistant Administrator, Office of Air and Radiation. For the reasons stated in the preamble, title 40, chapter I, part 65 of the Code of Federal Regulations is amended as follows: I PART 65—[AMENDED] 1. The authority citation for part 65 continues to read as follows: I Authority: 42 U.S.C. 7401 et seq. Subpart A—[Amended] 2. In § 65.157, introductory text for paragraph (c) is added following the paragraph (c) heading to read as follows: I § 65.157 Performance test and flare compliance determination requirements. * * * * * (c) * * * Except as specified in paragraphs (c)(1)(viii), (c)(1)(ix), (c)(1)(x), and (c)(1)(xi) of this section, unless a waiver of performance testing or flare compliance determination is obtained under this section or the conditions of another subpart of this part, the owner or operator shall perform such tests specified in the following: * * * * * [FR Doc. E7–25293 Filed 12–27–07; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0116; FRL–8342–7] Dimethenamid; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for residues of dimethenamid in or on hop, dried cones; pumpkin, radish (roots and tops); rutabaga (roots and tops); turnip greens; turnip (roots and tops); and winter squash. The E:\FR\FM\28DER1.SGM 28DER1 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations Interregional Research Project No. 4 (IR4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also modifies 40 CFR 180.464, section (b) by deleting the existing time-limited tolerance for winter squash as a permanent tolerance is being established by this action. 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–2007–0116. 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: Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–7610; e-mail address: jackson.sidney@epa.gov. SUPPLEMENTARY INFORMATION: pwalker on PROD1PC71 with RULES 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 VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 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–2007–0116 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 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 73627 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–2007–0116, 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 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 6E7152) by IR-4. The petition requested that 40 CFR 180.464 be amended by establishing a tolerance for residues of the herbicide dimethenamid, 1 (R,S)-2-chloro-N-[(1methyl-2-methoxy) ethyl]-N-(2,4dimethylthien-3-yl)-acetamide) in or on hop, dried cones at 0.05 parts per million (ppm); pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.1 ppm; and winter squash at 0.01 ppm. That notice referenced a summary of the petition prepared by BASF Corporation, 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 approved regionally restricted tolerances for pumpkin and winter E:\FR\FM\28DER1.SGM 28DER1 73628 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations squash for States of Oregon and Washington only, in that supporting data are limited to EPA growing Region 12. The reason for these changes is further explained in the supporting document for this action, entitled, ‘‘Dimethenamid-P. Petition for Registration for Uses Turnips and Hops. Summary of Analytical Chemistry and Residue Data. Petition 6E7152,’’ in docket ID number EPA–HQ–OPP–2007– 0116. pwalker on PROD1PC71 with RULES 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 residues of dimethenamid on hop, dried cones at 0.05 ppm; pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.1 ppm; and winter squash at 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 the validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 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 dimethenamid as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as EPA–HQ–OPP–2007–0116 in that docket. 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 (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 dimethenamid used for human risk assessment can be found at PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 http://www.regulations.gov in document, ‘‘Dimethenamid-P. Amended Human Health Risk Assessment for a Proposal for the Establishment of Tolerances for Dimethenamid-P Use on Winter Squash, Pumpkin, Radish (Roots and Tops), Rutabaga (Roots and Tops), Turnip (Roots, Tops and Greens) and on Hops, Dried Cones,’’ at docket ID number EPA–HQ–OPP–2007–0116. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to dimethenamid, EPA considered exposure under the petitioned-for tolerances as well as all existing dimethenamid tolerances in (40 CFR 180.464). EPA assessed dietary exposures from dimethenamid 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. In estimating acute dietary exposure, EPA used Dietary Exposure Evaluation Model/Food Consumption Intake Database (DEEM/FCID) Version 2.03 which incorporates food consumption information from the U.S. Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). An appropriate acute endpoint attributable to a single dose was selected for the population subgroup females 13-49. The acute dietary analysis was conducted for dimethenamid assuming tolerance level residues, default processing factors, and 100% crop treated (CT) information. ii. Chronic exposure. In conducting the chronic dietary exposure (food and drinking water assessment), EPA used consumption data from the USDA 1994– 1996 and 1998 Nationwide CSFII. The chronic dietary exposure assessment was conducted for dimethenamid assuming tolerance level residues, default processing factors, and 100%CT information. iii. Cancer. Dimethenamid is a category ‘‘C’’ possible human carcinogen. The chronic reference dose (cRfD) of 0.05 milligram/kilogram/day (mg/kg/day) used for risk assessment is based on non-cancer precursor effects in the liver; therefore, the cRfD is considered protective of both cancer and non-cancer effects. A separate cancer exposure assessment was not performed. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure E:\FR\FM\28DER1.SGM 28DER1 pwalker on PROD1PC71 with RULES Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations analysis and risk assessment for dimethenamid 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 dimethenamid. 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 EPA’s Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of dimethenamid for acute exposures are estimated to be 66.7 parts per billion (ppb) for surface water and 1.0 ppb for ground water. The EDWCs for chronic exposures are estimated to be 20.2 ppb for surface water and 1.0 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The EDWCs for use sites with the highest values were used. For acute dietary risk assessment, the water concentration value of 66.7 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 20.2 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). Dimethenamid is not registered for use on any sites that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to dimethenamid and any other substances and dimethenamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 not assumed that dimethenamid 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 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 is no concern for increased qualitative and/or quantitative susceptibility following prenatal and postnatal exposure to dimethenamid in rats and rabbits. In the developmental toxicity study in rats there was an increased incidence of postimplantation loss and minor skeletal variations. In the developmental toxicity study in rabbits, late resorptions and minor skeletal variations were observed at the highest dose tested. In the rabbit, the developmental effects occurred at the same dose as maternal toxicity; whereas in the rat, the developmental effects occurred at much higher doses than in the dams. The reproduction study showed decreases in body weight in both pups and parental animals at the same dose levels. 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 dimethenamid is complete. ii. There is no indication that dimethenamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 73629 iii. There is no evidence that dimethenamid 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%CT and tolerance-level residues which results in very high-end estimates of dietary exposure. The dietary drinking water assessment utilizes values generated by modeland associated modeling parameters which are designed to provide health protective, high-end estimates of water concentrations. These assessments will not underestimate the exposure and risks posed by dimethenamid. 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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to dimethenamid will occupy <1 % of the aPAD at the 95th percentile for females 13-49 years old, the population group of concern for acute dimethenamid exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dimethenamid from food and water will utilize 3% of the cPAD for all infants (<1 year old), the subpopulation group with greatest exposure. There are no residential uses for dimethenamid that result in chronic residential exposure to dimethenamid. 3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Dimethenamid is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency’s level of concern (LOC). A E:\FR\FM\28DER1.SGM 28DER1 73630 Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations short-term aggregate risk assessment is not required. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Dimethenamid is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency’s level of concern. An intermediate-term aggregate risk assessment is not required. 5. Aggregate cancer risk for U.S. population. The chronic reference dose (cRfD) of 0.05 mg/kg/day used for risk assessment is based on non-cancer precursor effects in the liver; therefore, the cRfD and chronic risk assessment are considered protective of both cancer and non-cancer effects. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to dimethenamid residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography with a nitrogen phosphorus detector (GC/NPD) Method AM–0884–0193–1) 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. B. International Residue Limits There are no established or proposed Codex, Canadian or Mexican maximum residue limits (MRLs) for dimethenamid on any of the crops/commodities being proposed in this petition. pwalker on PROD1PC71 with RULES V. Conclusion Therefore, tolerances are established for residues of the herbicide dimethenamid, 1 (R,S)-2-chloro-N-[(1methyl-2-methoxy) ethyl]-N-(2,4dimethylthien-3-yl)-acetamide) in or on hop, dried cones at 0.05 parts per million (ppm); pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.1 ppm; and winter squash at 0.01 ppm. The existing time-limited tolerance for winter squash VerDate Aug<31>2005 23:53 Dec 27, 2007 Jkt 214001 shall be deleted as a permanent tolerance is being established by this action. 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 (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 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. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.464 is amended by alphabetically adding the following commodities to the table in paragraph (a), removing the text in paragraph (b), and reserving it, and adding text to paragraph (c) to read as follows: I § 180.464 Dimethenamid; tolerances for residues. (a) * * * Parts per million Commodity * * * * Hop, dried cones ...................... * * * * Radish, roots ............................ Radish, tops .............................. E:\FR\FM\28DER1.SGM 28DER1 * 0.05 * 0.01 0.01 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

Agencies

[Federal Register Volume 72, Number 248 (Friday, December 28, 2007)]
[Rules and Regulations]
[Pages 73626-73631]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25090]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0116; FRL-8342-7]


Dimethenamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
dimethenamid in or on hop, dried cones; pumpkin, radish (roots and 
tops); rutabaga (roots and tops); turnip greens; turnip (roots and 
tops); and winter squash. The

[[Page 73627]]

Interregional Research Project No. 4 (IR-4) requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation 
also modifies 40 CFR 180.464, section (b) by deleting the existing 
time-limited tolerance for winter squash as a permanent tolerance is 
being established by this action.

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-2007-0116. 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@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-2007-0116 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-2007-0116, 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 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 
6E7152) by IR-4. The petition requested that 40 CFR 180.464 be amended 
by establishing a tolerance for residues of the herbicide dimethenamid, 
1 (R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-
yl)-acetamide) in or on hop, dried cones at 0.05 parts per million 
(ppm); pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 
0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; 
turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 
0.1 ppm; and winter squash at 0.01 ppm. That notice referenced a 
summary of the petition prepared by BASF Corporation, 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 
approved regionally restricted tolerances for pumpkin and winter

[[Page 73628]]

squash for States of Oregon and Washington only, in that supporting 
data are limited to EPA growing Region 12. The reason for these changes 
is further explained in the supporting document for this action, 
entitled, ``Dimethenamid-P. Petition for Registration for Uses Turnips 
and Hops. Summary of Analytical Chemistry and Residue Data. Petition 
6E7152,'' in docket ID number EPA-HQ-OPP-2007-0116.

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 residues of dimethenamid on hop, dried cones at 0.05 ppm; 
pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; radish, tops at 0.01 
ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops at 0.1 ppm; turnip, 
greens at 0.1 ppm; turnip, roots at 0.01 ppm; turnip, tops at 0.1 ppm; 
and winter squash at 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 the 
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 dimethenamid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2007-0116 in that docket.

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 (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 dimethenamid used for 
human risk assessment can be found at http://www.regulations.gov in 
document, ``Dimethenamid-P. Amended Human Health Risk Assessment for a 
Proposal for the Establishment of Tolerances for Dimethenamid-P Use on 
Winter Squash, Pumpkin, Radish (Roots and Tops), Rutabaga (Roots and 
Tops), Turnip (Roots, Tops and Greens) and on Hops, Dried Cones,'' at 
docket ID number EPA-HQ-OPP-2007-0116.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to dimethenamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing dimethenamid tolerances in (40 
CFR 180.464). EPA assessed dietary exposures from dimethenamid 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.
    In estimating acute dietary exposure, EPA used Dietary Exposure 
Evaluation Model/Food Consumption Intake Database (DEEM/FCID) Version 
2.03 which incorporates food consumption information from the U.S. 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). An 
appropriate acute endpoint attributable to a single dose was selected 
for the population subgroup females 13-49. The acute dietary analysis 
was conducted for dimethenamid assuming tolerance level residues, 
default processing factors, and 100% crop treated (CT) information.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
(food and drinking water assessment), EPA used consumption data from 
the USDA 1994-1996 and 1998 Nationwide CSFII. The chronic dietary 
exposure assessment was conducted for dimethenamid assuming tolerance 
level residues, default processing factors, and 100%CT information.
    iii. Cancer. Dimethenamid is a category ``C'' possible human 
carcinogen. The chronic reference dose (cRfD) of 0.05 milligram/
kilogram/day (mg/kg/day) used for risk assessment is based on non-
cancer precursor effects in the liver; therefore, the cRfD is 
considered protective of both cancer and non-cancer effects. A separate 
cancer exposure assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure

[[Page 73629]]

analysis and risk assessment for dimethenamid 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 dimethenamid. 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 EPA's Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) and Screening Concentration in Ground 
Water (SCI-GROW) models, the estimated drinking water concentrations 
(EDWCs) of dimethenamid for acute exposures are estimated to be 66.7 
parts per billion (ppb) for surface water and 1.0 ppb for ground water. 
The EDWCs for chronic exposures are estimated to be 20.2 ppb for 
surface water and 1.0 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The EDWCs for use sites with 
the highest values were used. For acute dietary risk assessment, the 
water concentration value of 66.7 ppb was used to assess the 
contribution to drinking water. For chronic dietary risk assessment, 
the water concentration of value 20.2 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).
    Dimethenamid is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to dimethenamid and any other 
substances and dimethenamid 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 dimethenamid 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 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 is no concern for 
increased qualitative and/or quantitative susceptibility following 
prenatal and postnatal exposure to dimethenamid in rats and rabbits. In 
the developmental toxicity study in rats there was an increased 
incidence of post-implantation loss and minor skeletal variations. In 
the developmental toxicity study in rabbits, late resorptions and minor 
skeletal variations were observed at the highest dose tested. In the 
rabbit, the developmental effects occurred at the same dose as maternal 
toxicity; whereas in the rat, the developmental effects occurred at 
much higher doses than in the dams. The reproduction study showed 
decreases in body weight in both pups and parental animals at the same 
dose levels.
    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 dimethenamid is complete.
    ii. There is no indication that dimethenamid 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 dimethenamid 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%CT and tolerance-level residues which results in very high-end 
estimates of dietary exposure. The dietary drinking water assessment 
utilizes values generated by modeland associated modeling parameters 
which are designed to provide health protective, high-end estimates of 
water concentrations. These assessments will not underestimate the 
exposure and risks posed by dimethenamid.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to dimethenamid will occupy <1 % of the aPAD at the 95th percentile for 
females 13-49 years old, the population group of concern for acute 
dimethenamid exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
dimethenamid from food and water will utilize 3% of the cPAD for all 
infants (<1 year old), the subpopulation group with greatest exposure. 
There are no residential uses for dimethenamid that result in chronic 
residential exposure to dimethenamid.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Dimethenamid is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern 
(LOC). A

[[Page 73630]]

short-term aggregate risk assessment is not required.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Dimethenamid is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern. An intermediate-term aggregate risk assessment is not 
required.
    5. Aggregate cancer risk for U.S. population. The chronic reference 
dose (cRfD) of 0.05 mg/kg/day used for risk assessment is based on non-
cancer precursor effects in the liver; therefore, the cRfD and chronic 
risk assessment are considered protective of both cancer and non-cancer 
effects.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to dimethenamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with a 
nitrogen phosphorus detector (GC/NPD) Method AM-0884-0193-1) 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 established or proposed Codex, Canadian or Mexican 
maximum residue limits (MRLs) for dimethenamid on any of the crops/
commodities being proposed in this petition.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
dimethenamid, 1 (R,S)-2-chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-
dimethylthien-3-yl)-acetamide) in or on hop, dried cones at 0.05 parts 
per million (ppm); pumpkin at 0.01 ppm; radish, roots at 0.01 ppm; 
radish, tops at 0.01 ppm; rutabaga, roots at 0.01 ppm; rutabaga, tops 
at 0.1 ppm; turnip, greens at 0.1 ppm; turnip, roots at 0.01 ppm; 
turnip, tops at 0.1 ppm; and winter squash at 0.01 ppm. The existing 
time-limited tolerance for winter squash shall be deleted as a 
permanent tolerance is being established by this action.

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 (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 180.464 is amended by alphabetically adding the following 
commodities to the table in paragraph (a), removing the text in 
paragraph (b), and reserving it, and adding text to paragraph (c) to 
read as follows:


Sec.  180.464  Dimethenamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Hop, dried cones...........................................         0.05
                                * * * * *
Radish, roots..............................................         0.01
Radish, tops...............................................         0.01

[[Page 73631]]

 
Rutabaga, roots............................................         0.01
Rutabaga, tops.............................................          0.1
                                * * * * *
Turnip, greens.............................................          0.1
Turnip, roots..............................................         0.01
Turnip, tops...............................................          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-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-
yl)-acetamide) in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Pumpkin....................................................         0.01
Squash, winter.............................................         0.01
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-25090 Filed 12-27-07; 8:45 am]
BILLING CODE 6560-50-S