Pendimethalin; Pesticide Tolerance, 27456-27460 [E7-9428]

Download as PDF 27456 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations [(methylamino)carbonyl]phenyl]-1-(3chloro-2-pyridinyl)-1H-pyrazole-5- carboxamide) in or on the following raw agricultural commodities: Commodity Expiration/revocation date Parts per million Apple 0.25 05/01/2010 Apple, wet pomace 0.60 05/01/2010 7.0 05/01/2010 0.10 05/01/2010 Lettuce, head 4.0 05/01/2010 Lettuce, leaf 8.0 05/01/2010 Pear 0.30 05/01/2010 Pepper 0.50 05/01/2010 Spinach 13.0 05/01/2010 Squash 0.40 05/01/2010 Tomato 0.30 05/01/2010 Watermelon 0.20 05/01/2010 Celery Cucumber (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. E7–9206 Filed 5–15–07; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–0995; FRL–8120–2] Pendimethalin; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. jlentini on PROD1PC65 with RULES AGENCY: SUMMARY: This regulation establishes a tolerance for combined residues of pendimethalin and its metabolite, 4-[(1ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol in or on beans; beans, forage; beans, hay; and peas (except field peas) to replace the current tolerances for bean, lima, seed; bean, lima, succulent; bean, forage; bean, hay; and pea, succulent. BASF Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 16, 2007. Objections and requests for hearings must be received on or before July 16, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also VerDate Aug<31>2005 18:04 May 15, 2007 Jkt 211001 Unit I.C. of the SUPPLEMENTARY INFORMATION). EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2006–0995. To access the electronic docket, go to https:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at https://www.regulations.gov,or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Philip V. Errico, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 ADDRESSES: PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305–6663; e-mail address: errico.philip@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining E:\FR\FM\16MYR1.SGM 16MYR1 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 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. jlentini on PROD1PC65 with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site athttps://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2006–0995 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 July 16, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– HQ–OPP–2006–0995, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s VerDate Aug<31>2005 18:04 May 15, 2007 Jkt 211001 normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305– 5805. II. Petition for Tolerance In the Federal Register of January 24, 2007 (72 FR 3130) (FRL–8109–7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7149) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709–3528. The petition requested that 40 CFR 180.361 be amended by establishing a tolerance for combined residues of the herbicide, pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol, in or on beans; beans, forage; beans, hay; and peas (except field peas) each at 0.1 parts per million (ppm). That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing. These proposed tolerances seek to correct an inadvertent error made by EPA in 2001 when EPA amended the pendimethalin beans and peas tolerances following completion of the pendimethalin reregistration eligibility determination under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq., and FFDCA tolerance reassessment. (66 FR 63192, December 5, 2001). In an attempt to clarify the coverage of the then existing beans and peas tolerances, EPA mistakenly narrowed the scope of the existing tolerances. This action reestablishes the beans and peas tolerances with the same coverage that pre-dated the 2001 amendments and using the terms originally recommended by the tolerance reassessment decision. Specifically, the proposed amendments to the pendimethalin tolerance would replace the current tolerances for bean, lima, seed; bean, lima, succulent; bean, forage; bean, hay; with tolerances for beans; beans, forage; beans, hay and the current tolerance for pea, succulent with a tolerance for peas (except field peas). The terms beans and peas are defined under 40 CFR 180.1(g) to encompass bean and pea commodities not covered by the current tolerances. PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 27457 III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of the FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for combined residues of pendimethalin and its metabolite on beans; beans, forage; beans, hay; and peas (except field peas) each at 0.1 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 pendimethalin as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov. The referenced document is available in the docket established by this action, which is E:\FR\FM\16MYR1.SGM 16MYR1 27458 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations described under ADDRESSES, and is identified as EPA–HQ–OPP–2006–0995 in that docket. jlentini on PROD1PC65 with RULES B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/ safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www.epa.gov/fedrgstr/EPA-PEST/1997/ November/Day-26/p30948.htm. A summary of the toxicological endpoints for pendimethalin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 12, 2006 (71 FR 18628) (FRL–7770–4). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pendimethalin, EPA considered exposure under the petition for tolerances as well as all existing pendimethalin tolerances in (40 CFR 180.361). EPA assessed dietary exposures from pendimethalin in food as follows: VerDate Aug<31>2005 18:04 May 15, 2007 Jkt 211001 i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1–day or single exposure. No such effects were identified in the toxicological studies for pendimethalin; 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, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. iii. Cancer. Pendimethalin is classified ‘‘Group C’’, possible human carcinogen, chemical based on a statistically significant increased trend and pair-wise comparison between the high dose group and controls for thyroid follicular cell adenomas in male and female rats. The Agency used a nonquantitative approach (i.e., non-linear, RfD approach) since mode of action studies are available that demonstrate that the thyroid tumors are due to a thyroid-pituitary imbalance, and also since pendimethalin was shown to be non-mutagenic in mammalian somatic cells and germ. The chronic risk assessment is considered to be protective of any cancer effects; therefore, a separate quantitative cancer aggregate risk assessment is not required. iv. Anticipated residue and percent crop treated (PCT) information. Tolerance level residues were assumed for all food commodities with current and proposed pendimethalin tolerances, and it was assumed that all of the crops included in the analysis were treated (i.e. 100% crop treated). 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for pendimethalin 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 pendimethalin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttps://www.epa.gov/ oppefed1/models/water/index.htm. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCIGROW) models, the estimated environmental concentrations (EECs) of pendimethalin for peak exposures are estimated to be 39 parts per billion (ppb) for surface water and 0.024 ppb for ground water. The EECs for chronic exposures are estimated to be 4.8 ppb for surface water and 0.024 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 of value 39 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). Pendimethalin is currently registered for the following residential non-dietary sites: Landscape, grounds plantings, ornamental crops, turf grass, and lawns. EPA assessed residential exposure using the following assumptions: Exposures are short-term in duration, and consist of dermal (for adults and children), and oral (hand-to-mouth, object-to-mouth, and soil ingestion, for children only). The Agency combines risk values resulting from separate exposure scenarios when it is likely they can occur simultaneously, based on the usepattern and the behavior associated with the exposed population. The LOC for oral, dermal and inhalation exposure is an MOE of less than 300. The residential exposure estimate for adults, consisting of dermal exposure only, results in a total MOE of 740, and is therefore not of concern. The residential exposure for children results in a total MOE (dermal + oral) of 410 at an application rate of 2 lb ai/acre, and an MOE of 400 for an application rate of 3 lb ai/acre. Residential aggregate exposure is not of concern. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to E:\FR\FM\16MYR1.SGM 16MYR1 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations pendimethalin and any other substances and pendimethalin 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 pendimethalin 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 https:// www.epa.gov/pesticides/cumulative. jlentini on PROD1PC65 with RULES D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (10X) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. The database for pendimethalin does not indicate a potential for increased toxicological sensitivity from either prenatal or postnatal exposures. 3. Conclusion. In September 2006 we said the following: There was no evidence of qualitative or quantitative susceptibility in the submitted data. Additionally, exposure estimates are based on very conservative data and assumptions that will overstate exposure to pendimethalin. There is, however, a concern that perturbation of thyroid homeostasis may lead to hypothyroidism, and possibly result in adverse effects on the developing nervous system. Since thyroid toxicity parameters were not measured in the developmental toxicity studies, the Agency has requested a developmental thyroid assay be conducted to evaluate the impact of pendimethalin on thyroid hormones, structure, and/or thyroid hormone homeostasis during development. The Agency has retained the additional 10X FQPA safety factor in the form of a database uncertainty factor (UF[DB]) for the lack of the study, to be VerDate Aug<31>2005 18:04 May 15, 2007 Jkt 211001 applied in determining pendimethalin risks. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. 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 margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. Acute risk. No toxic effects attributable to a single dose were identified for pendimethalin. Therefore, an acute risk assessment is not warranted for this chemical. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pendimethalin from food and water will utilize 26% of the cPAD for the population group children 1-2. Based the use pattern, chronic residential exposure to residues of pendimethalin is not expected. 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). Pendimethalin is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for pendimethalin. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of 580 for adult males, 520 for adult females, 310 for children for an application rate of 2 lbs ai/acre to residential turf, and 300 for children for an application rate of 3 lbs ai/acre to residential turf. 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). Based on currently requested uses, there are no scenarios that are likely to result in intermediateterm exposure (30 to 180 days, continuous. Therefore, an intermediate- PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 27459 term risk assessment was not conducted. 5. Aggregate cancer risk for U.S. population. The Agency classifies pendimethalin as a ‘‘Group C’’ (possible human) cancinogen based on thyroid follicular cell adenomas in rats. A nonquantitative approach, non-linear RfD approach is used to assess the cancer risk using a chronic assessment, which is considerated protective of any cancer effects: Because exposure to pendimethalin does not exceed the chronic RfD, pendimethalin is not expected to pose a cancer risk. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pendimethalin residues. IV. Other Considerations A. Analytical Enforcement Methodology Enforcement analytical methods using gas chromatography and an electron capture detector are available in the Pesticide Analytical Manual, Volume II. B. International Residue Limits There are no established or proposed Codex Maximum Residue Levles (MRLs) for pendimethalin residues. Therefore, there are no questions of compatibility with respect to Codex MRLs and U.S. tolerances. C. Response to Comments There were no responses to the Notice of Filing for the requested tolerance in beans and peas. V. Conclusion Therefore, the tolerance is established for combined residues of pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl alcohol, in or on beans; beans, forage; beans, hay; and peas (except field peas) all at 0.1 ppm each. 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, E:\FR\FM\16MYR1.SGM 16MYR1 27460 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations jlentini on PROD1PC65 with RULES 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 VerDate Aug<31>2005 18:04 May 15, 2007 Jkt 211001 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: May 8, 2007. Donald R. Stubbs, Acting 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 180.361 is amended by revising the tolerances for ‘‘Bean, lima, seed’’; ‘‘Bean, lima, succulent’’; ‘‘Bean, forage’’; ‘‘Bean, hay’’; and ‘‘Pea, succulent‘‘, which will be revoked due to an administrative error, with the entries to the table in paragraph (a) to read as follows: I § 180.361 Pendimethalin; tolerances for residues. ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0160; FRL–8130–6] Aspergillus flavus NRRL 21882 on Corn; Temporary Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the Aspergillus flavus NRRL 21882 on corn when applied aerially once per season at the first sign of corn tasseling to reduce aflatoxin-producing Aspergillus flavus. Acta Group, 1203 Nineteenth St., NW., Suite 300, Washington, DC 20036–2401 on behalf of Circle One Global, Inc. One Arthur St. P.O. Box 28, Shellman, GA 39886–0028 submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of Aspergillus flavus NRRL 21882. The temporary tolerance exemption expires on May 2, 2009. DATES: This regulation is effective May 16, 2007. Objections and requests for hearings must be received on or before June 15, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). EPA has established a docket for this action under docket identification (ID) number EPA–HQ– Commodity Parts per million OPP–2007–0160. To access the electronic docket, go to https:// * * * * * Beans .............................. 0.10 www.regulations.gov, select ‘‘Advanced Beans, forage ................. 0.10 Search,’’ then ‘‘Docket Search.’’ Insert Beans, hay ...................... 0.10 the docket ID number where indicated and select the ‘‘Submit’’ button. Follow * * * * * Peas (except field peas) 0.10 the instructions on the regulations.gov web site to view the docket index or * * * * * access available documents. All documents in the docket are listed in * * * * * the docket index available in [FR Doc. E7–9428 Filed 5–15–07; 8:45 am] regulations.gov. Although listed in the BILLING CODE 6560–50–S 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. ADDRESSES: (a) * * * PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 E:\FR\FM\16MYR1.SGM 16MYR1

Agencies

[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Rules and Regulations]
[Pages 27456-27460]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9428]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0995; FRL-8120-2]


Pendimethalin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of pendimethalin and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-
3,5-dinitrobenzyl alcohol in or on beans; beans, forage; beans, hay; 
and peas (except field peas) to replace the current tolerances for 
bean, lima, seed; bean, lima, succulent; bean, forage; bean, hay; and 
pea, succulent. BASF Corporation requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 16, 2007. Objections and 
requests for hearings must be received on or before July 16, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0995. To access the 
electronic docket, go to https://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at https://www.regulations.gov,or, if 
only available in hard copy, at the OPP Regulatory Public Docket in Rm. 
S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket telephone number 
is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Philip V. Errico, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6663; e-mail address: 
errico.philip@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining

[[Page 27457]]

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 https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site athttps://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2006-0995 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 July 16, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2006-0995, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of January 24, 2007 (72 FR 3130) (FRL-8109-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6F7149) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR 
180.361 be amended by establishing a tolerance for combined residues of 
the herbicide, pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol, in or on beans; beans, forage; beans, 
hay; and peas (except field peas) each at 0.1 parts per million (ppm). 
That notice referenced a summary of the petition prepared by BASF 
Corporation, the registrant, which is available to the public in the 
docket, https://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    These proposed tolerances seek to correct an inadvertent error made 
by EPA in 2001 when EPA amended the pendimethalin beans and peas 
tolerances following completion of the pendimethalin reregistration 
eligibility determination under the Federal Insecticide, Fungicide, and 
Rodenticide Act, 7 U.S.C. 136 et seq., and FFDCA tolerance 
reassessment. (66 FR 63192, December 5, 2001). In an attempt to clarify 
the coverage of the then existing beans and peas tolerances, EPA 
mistakenly narrowed the scope of the existing tolerances. This action 
re-establishes the beans and peas tolerances with the same coverage 
that pre-dated the 2001 amendments and using the terms originally 
recommended by the tolerance reassessment decision. Specifically, the 
proposed amendments to the pendimethalin tolerance would replace the 
current tolerances for bean, lima, seed; bean, lima, succulent; bean, 
forage; bean, hay; with tolerances for beans; beans, forage; beans, hay 
and the current tolerance for pea, succulent with a tolerance for peas 
(except field peas). The terms beans and peas are defined under 40 CFR 
180.1(g) to encompass bean and pea commodities not covered by the 
current tolerances.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to the FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerance 
for combined residues of pendimethalin and its metabolite on beans; 
beans, forage; beans, hay; and peas (except field peas) each at 0.1 
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 pendimethalin as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://
www.regulations.gov. The referenced document is available in the docket 
established by this action, which is

[[Page 27458]]

described under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0995 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 (UF) are 
used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable uncertainty/safety factors. Short-, intermediate, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the margin of exposure (MOE) called for by the product of 
all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for pendimethalin used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 12, 2006 (71 FR 18628) (FRL-
7770-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pendimethalin, EPA considered exposure under the petition 
for tolerances as well as all existing pendimethalin tolerances in (40 
CFR 180.361). EPA assessed dietary exposures from pendimethalin in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
pendimethalin; 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, EPA assumed all foods for which 
there are tolerances were treated and contain tolerance-level residues.
    iii. Cancer. Pendimethalin is classified ``Group C'', possible 
human carcinogen, chemical based on a statistically significant 
increased trend and pair-wise comparison between the high dose group 
and controls for thyroid follicular cell adenomas in male and female 
rats. The Agency used a non-quantitative approach (i.e., non-linear, 
RfD approach) since mode of action studies are available that 
demonstrate that the thyroid tumors are due to a thyroid-pituitary 
imbalance, and also since pendimethalin was shown to be non-mutagenic 
in mammalian somatic cells and germ. The chronic risk assessment is 
considered to be protective of any cancer effects; therefore, a 
separate quantitative cancer aggregate risk assessment is not required.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Tolerance level residues were assumed for all food commodities with 
current and proposed pendimethalin tolerances, and it was assumed that 
all of the crops included in the analysis were treated (i.e. 100% crop 
treated).
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for pendimethalin 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 pendimethalin. Further information regarding 
EPA drinking water models used in pesticide exposure assessment can be 
found athttps://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
pendimethalin for peak exposures are estimated to be 39 parts per 
billion (ppb) for surface water and 0.024 ppb for ground water. The 
EECs for chronic exposures are estimated to be 4.8 ppb for surface 
water and 0.024 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 of value 39 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).
    Pendimethalin is currently registered for the following residential 
non-dietary sites: Landscape, grounds plantings, ornamental crops, turf 
grass, and lawns. EPA assessed residential exposure using the following 
assumptions: Exposures are short-term in duration, and consist of 
dermal (for adults and children), and oral (hand-to-mouth, object-to-
mouth, and soil ingestion, for children only). The Agency combines risk 
values resulting from separate exposure scenarios when it is likely 
they can occur simultaneously, based on the use-pattern and the 
behavior associated with the exposed population. The LOC for oral, 
dermal and inhalation exposure is an MOE of less than 300. The 
residential exposure estimate for adults, consisting of dermal exposure 
only, results in a total MOE of 740, and is therefore not of concern. 
The residential exposure for children results in a total MOE (dermal + 
oral) of 410 at an application rate of 2 lb ai/acre, and an MOE of 400 
for an application rate of 3 lb ai/acre. Residential aggregate exposure 
is not of concern.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to

[[Page 27459]]

pendimethalin and any other substances and pendimethalin 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 pendimethalin 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 https://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (10X) tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA safety factor. In applying 
this provision, EPA either retains the default value of 10X when 
reliable data do not support the choice of a different factor, or, if 
reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional uncertainty/safety 
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The database for 
pendimethalin does not indicate a potential for increased toxicological 
sensitivity from either prenatal or postnatal exposures.
    3. Conclusion. In September 2006 we said the following: There was 
no evidence of qualitative or quantitative susceptibility in the 
submitted data. Additionally, exposure estimates are based on very 
conservative data and assumptions that will overstate exposure to 
pendimethalin. There is, however, a concern that perturbation of 
thyroid homeostasis may lead to hypothyroidism, and possibly result in 
adverse effects on the developing nervous system. Since thyroid 
toxicity parameters were not measured in the developmental toxicity 
studies, the Agency has requested a developmental thyroid assay be 
conducted to evaluate the impact of pendimethalin on thyroid hormones, 
structure, and/or thyroid hormone homeostasis during development. The 
Agency has retained the additional 10X FQPA safety factor in the form 
of a database uncertainty factor (UF[DB]) for the lack of the study, to 
be applied in determining pendimethalin risks.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the acute population adjusted 
dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and 
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. 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 margin of exposure (MOE) called 
for by the product of all applicable uncertainty/safety factors is not 
exceeded.
    1. Acute risk. No toxic effects attributable to a single dose were 
identified for pendimethalin. Therefore, an acute risk assessment is 
not warranted for this chemical.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pendimethalin from food and water will utilize 26% of the cPAD for the 
population group children 1-2. Based the use pattern, chronic 
residential exposure to residues of pendimethalin is not expected.
    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).
    Pendimethalin is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for pendimethalin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs of 580 for adult males, 
520 for adult females, 310 for children for an application rate of 2 
lbs ai/acre to residential turf, and 300 for children for an 
application rate of 3 lbs ai/acre to residential turf.
    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). Based on 
currently requested uses, there are no scenarios that are likely to 
result in intermediate-term exposure (30 to 180 days, continuous. 
Therefore, an intermediate-term risk assessment was not conducted.
    5. Aggregate cancer risk for U.S. population. The Agency classifies 
pendimethalin as a ``Group C'' (possible human) cancinogen based on 
thyroid follicular cell adenomas in rats. A non-quantitative approach, 
non-linear RfD approach is used to assess the cancer risk using a 
chronic assessment, which is considerated protective of any cancer 
effects: Because exposure to pendimethalin does not exceed the chronic 
RfD, pendimethalin is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Enforcement analytical methods using gas chromatography and an 
electron capture detector are available in the Pesticide Analytical 
Manual, Volume II.

B. International Residue Limits

    There are no established or proposed Codex Maximum Residue Levles 
(MRLs) for pendimethalin residues. Therefore, there are no questions of 
compatibility with respect to Codex MRLs and U.S. tolerances.

C. Response to Comments

    There were no responses to the Notice of Filing for the requested 
tolerance in beans and peas.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] 
and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl 
alcohol, in or on beans; beans, forage; beans, hay; and peas (except 
field peas) all at 0.1 ppm each.

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,

[[Page 27460]]

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: May 8, 2007.
Donald R. Stubbs,
Acting 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 180.361 is amended by revising the tolerances for ``Bean, 
lima, seed''; ``Bean, lima, succulent''; ``Bean, forage''; ``Bean, 
hay''; and ``Pea, succulent``, which will be revoked due to an 
administrative error, with the entries to the table in paragraph (a) to 
read as follows:


Sec.  180.361  Pendimethalin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Beans................................................               0.10
Beans, forage........................................               0.10
Beans, hay...........................................               0.10
                                * * * * *
Peas (except field peas).............................               0.10
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-9428 Filed 5-15-07; 8:45 am]
BILLING CODE 6560-50-S
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