Mandipropamid; Pesticide Tolerance, 2812-2816 [E8-677]

Download as PDF 2812 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations Commodity Parts per million * * * * * Berry, low growing subgroups 13–07G ............................................................................................................................... Bushberry subgroup 13–07B ............................................................................................................................................... Caneberry subgroup 13–07A .............................................................................................................................................. * * * * * Onion, bulb, subgroup 3–07A .............................................................................................................................................. Onion, green, subgroup 3–07B ........................................................................................................................................... * * * * * * * * * * [FR Doc. E8–683 Filed 1–15–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2007–0461; FRL–8346–6] Mandipropamid; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a tolerance for residues of mandipropamid, 4-chloro-N-[2-[3methoxy-4-(2propynyloxy)phenyl]ethyl]-alpha-(2propynyloxy)-benzeneacetamide in or on Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; okra; vegetable, leafy except brassica, group 4; vegetable, tuberous and corm, subgroup 1C; grape; grape, raisin; onion, dry bulb; onion, green; and potato, wet peel. Syngenta Crop Protection Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective January 16, 2008. Objections and requests for hearings must be received on or before March 17, 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–2007–0461. 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 ebenthall on PRODPC61 with RULES SUMMARY: VerDate Aug<31>2005 15:01 Jan 15, 2008 Jkt 214001 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: Rose Mary Kearns, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305-5611; e-mail address: kearns.rosemary@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. PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 0.60 1.6 1.6 0.02 4.5 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–2007–0461 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 March 17, 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 E:\FR\FM\16JAR1.SGM 16JAR1 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations 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–2007–0461, 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. ebenthall on PRODPC61 with RULES ADDRESSES. II. Petition for Tolerance In the Federal Register of July 25, 2007 (72 FR 40877) (FRL–8137–1) and October 31, 2007 (72 FR 61637) (FRL 8154-8) EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP7F7184 and 6F7057) by Syngenta Crop Protection Inc., P.O. Box 18300, Greensboro, NC 27419. The petition (6F7057) requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide mandipropamid, 4-chloroN-[2-[3-methoxy-4-(2propynyloxy)phenyl]ethyl]-alpha-(2propynyloxy)-benzeneacetamide, in or on Brassica, head and stem, Subgroup 5A at 3 parts per million (ppm); Brassica, leafy greens, subgroup 5B at 30 ppm; vegetable, cucurbit, group 9 at .3 ppm; vegetable, fruiting, group 8 at 1 ppm; vegetable, leafy except Brassica, group 4 at 20 ppm; vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; grape at 2 ppm; grape, raisin at 4 ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 ppm; and tomato paste at 1.3 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, which is available to the public in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA’s response to these comments is discussed in Unit IV.B.. Based upon review of the data supporting the petition, EPA has recommended the inclusion of okra in Crop Group 8 (Vegetable, Fruiting). VerDate Aug<31>2005 15:01 Jan 15, 2008 Jkt 214001 However, a separate tolerance for okra must be listed in the 40 CFR 180.637, until the new crop group regulation is published. A tolerance for tomato paste was requested. However, the maximum expected residue in tomato paste and puree resulting from the proposed use will be covered by the recommended tolerance for vegetable, fruiting, crop group 8. A separate tolerance is being established for potato, wet peel, even though it was not requested. The maximum expected residue in potato, wet peel resulting from the proposed use is 0.03 ppm which was calculated by multiplying the HAFT of <0.01 ppm by the observed concentration factor of >3x. Potatoes have a separate tolerance under the vegetable, tuberous and corm subgroup 1C. 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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of mandipropamid on Brassica, head and stem, subgroup 5A at 3 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; vegetable, cucurbit, group 9 at 0.6 ppm; vegetable, fruiting, group 8 at 1 ppm; okra at 1.0 ppm; vegetable, leafy except Brassica, group 4 at 20 ppm; vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; grape at 1.4 ppm; grape, raisin at PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 2813 3 ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 ppm; and okra at 1 ppm and potato, wet peel at 0.03 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 mandipropamid as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found in the docket established by this action, which is described under ADDRESSES, and is identified as ‘‘Mandipropamid: Human Health Risk Assessment for Proposed Uses’’ 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 E:\FR\FM\16JAR1.SGM 16JAR1 2814 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations 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/pesticides/factsheets/ riskassess.htm. A summary of the toxicological endpoints for mandipropamid used for human risk assessment is shown in Table 1 of this unit. TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR MANDIPROPAMID FOR USE IN DIETARY HUMAN RISK ASSESSMENT Exposure/Scenario Point of Departure Uncertainty/FQPA Safety Factors RfD, PAD, Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary (General Population, including Infants and Children) N/A N/A N/A No appropriate endpoint was identified. Acute Dietary(Females years of age) N/A N/A N/A No appropriate endpoint was identified. NOAEL = 5 mg/kg/ day UFA = 10X ............. UFH = 10X FQPA SF = 1X Chronic RfD = 0.05 mg/kg/day cPAD = 0.05 mg/ kg/day Chronic toxicity – dogs LOAEL = 40 mg/kg/day, based on evidence of liver toxicity (increased incidence and severity of microscopic pigment in the liver and increased alkaline phosphatase activity in both sexes as well as increased alanine aminotransferase activity in males). 13-49 Chronic Dietary (All Populations) Cancer ‘‘Not Likely to be Carcinogenic to Humans.’’ No treatment-related tumors observed in carcinogenicity studies in rats and mice. A cancer risk assessment is not needed. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (c = chronic). RfD = reference dose. N/A = not applicable. ebenthall on PRODPC61 with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mandipropamid, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from mandipropamid 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 mandipropamid; 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, or 1998; CSFII. As to residue levels in food, EPA relied upon tolerance level residues and percent crop treated (PCT) information for all commodities A unrefined chronic exposure assessment that assumes 100% crop treated was conducted for the proposed Section 3 uses of mandipropamid. The DEEM analysis incorporates estimates of drinking water concentrations from the Environmental VerDate Aug<31>2005 15:01 Jan 15, 2008 Jkt 214001 Fate and Effects Division directly into the analysis. The chronic dietary exposure analysis for mandipropamid results in dietary risk estimates for food and water that are below the Agency’s level of concern for chronic dietary exposure. iii. Cancer. There were no treatmentrelated tumors observed in carcinogenicity studies in rats and mice. Mandipropamid is classified as not likely to be a human carcinogen. Therefore, a cancer dietary exposure assessment was not performed. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for mandipropamid 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 mandipropamid. 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 First Index Reservoir Screening Tool (FIRST), and Screening Concentration in Ground Water (SCI- PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 GROW) models, the estimated environmental concentrations (EECs) of mandipropamid for acute exposures are estimated to be 25.2 parts per billion (ppb) for surface water and 0.05 ppb for ground water. The EECs for the aquatic degradates SYN500003 and SYN504851 are estimated to be 2.32 and 8.99 ppb for surface water and 0.6 and 1.7 ppb for ground water. The combined level of mandipropamid and the degradates in surface water is 36.5 ppb. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the acute water concentration of value 36.5 ppb was used to conservatively 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). Mandipropamid 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 E:\FR\FM\16JAR1.SGM 16JAR1 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations ebenthall on PRODPC61 with RULES 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 mandipropamid and any other substances and mandipropamid 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 mandipropamid 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 evidence (quantitative or qualitative) of increased susceptibility and no residual uncertainties with regard to prenatal toxicity following in utero exposure to rats or rabbits (developmental studies) and pre and/or post-natal exposures to rats (reproduction study). 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 toxicological database for mandipropamid is complete. ii. The toxicity data showed no increase in qualitative or quantitative VerDate Aug<31>2005 15:01 Jan 15, 2008 Jkt 214001 susceptibility in fetuses and pups with in utero and post-natal exposure. iii. The toxicity data indicates that there are no neurotoxic effects. iv. The dietary food exposure assessment is based on tolerance-level residues and assumes 100% crop treated for all commodities, which results in very high-end estimates of dietary exposure. v. The dietary drinking water assessment is based on values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. vi. No residential uses are proposed at this time. 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. No acute dietary endpoint based on effects attributable to a single dose could be identified based on the toxicology data currently available for mandipropamid. Therefore, mandipropamid is not expected to pose an acute risk. 2. Chronic risk. There are no residential uses proposed or registered for mandipropamid, and therefore aggregate risk is equal to that from consumption of food and water. Chronic aggregate risk estimates associated with exposure to mandipropamid residues in food and water do not exceed the Agency’s level of concern. For mandipropamid, the chronic dietary exposure estimate was 22% of the cPAD for the U.S. population and was 30% of the cPAD for the highest exposed population subgroup, children 1-2 years of age. 3. Short-term and intermediate-term risk. Short and intermediate-term dermal exposures and risks were not assessed for mandipropamid, since mandipropamid is not registered for use on any sites that would result in residential exposure. 4. Aggregate cancer risk for U.S. population. Aggregate cancer risk was not assessed because mandipropamid is not likely to be carcinogenic in humans. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 2815 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to mandipropamid residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology Analytical Method RAM 415/01 Residue Analytical Method for the Determination of Mandipropamid in Crop Samples. Final Determination by LC/MS/MS and the Analytical Method Development and Validation (German S19) for the determination of residues of MA Mandipropamid in or on Plant Matrices 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 specific CODEX, Canadian or Mexican maximum residue limits (MRLs) for mandipropamid. C. General Response to Comments Several comments were received from a private citizen objecting to establishment of tolerances. The agency has received similar comments from this commenter on numerous previous occasions. Refer to Federal Register 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), 69 FR 63096-63098 (October 29, 2004) for the Agency’s response to these objections. In addition, the commenter noted several adverse effects seen in animal toxicology studies with mandipropamid and claims because of these effects no tolerance should be approved. EPA has found, however, that there is reasonable certainty of no harm to humans after considering these toxicological studies and the exposure levels of humans to mandipropamid. V. Conclusion Therefore, the tolerances are established for residues of mandipropamid, 4-chloro-N-[2-[3methoxy-4-(2propynyloxy)phenyl]ethyl]-alpha-(2propynyloxy)-benzeneacetamide, in or on Brassica, head and stem, subgroup 5A at 3 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; vegetable, cucurbit, group 9 at 0.6 ppm; vegetable, fruiting, group 8 at 1.0 ppm; okra at 1.0 ppm; vegetable, leafy, except Brassica, group 4 at 20 ppm; vegetable, tuberous E:\FR\FM\16JAR1.SGM 16JAR1 2816 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Rules and Regulations ebenthall on PRODPC61 with RULES and corm, subgroup 1C at 0.01 ppm; grape at 1.4 ppm; grape, raisin at 3.0 ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 ppm; and potato, wet peel at 0.03 ppm. A tolerance for tomato paste is not being established because residue expected will be covered by the vegetable, fruiting crop group 8. 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, VerDate Aug<31>2005 15:01 Jan 15, 2008 Jkt 214001 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). Commodity Parts per million Brassica, head and stem, subgroup 5A ................ Brassica, leafy greens, subgroup 5B ................ Vegetable, cucurbit, group 9 ........................ Vegetable, fruiting, group 8 .................................. Vegetable, leafy except Brassica, group 4 ........ Vegetable, tuberous and corm, subgroup 1C ..... Grape .............................. Grape, raisin ................... Okra ................................ Onion, dry bulb ............... Onion, green ................... Potato, wet peel .............. 3 25 0.6 1.0 20 0.01 1.4 3.0 1.0 0.05 4 0.03 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent tolerances. [Reserved] [FR Doc. E8–677 Filed 1–15–08; 8:45 am] BILLING CODE 6560–50–S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 List of Subjects in 40 CFR Part 180 [Docket No. FEMA–8007] Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Suspension of Community Eligibility Dated: January 8, 2008. Debra Edwards, Director, Office of Pesticide Programs. SUMMARY: This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. DATES: Effective Dates: The effective date of each community’s scheduled suspension is the third date (‘‘Susp.’’) listed in the third column of the following tables. 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 180.637 is added to read as follows: I § 180.637 Mandipropamid; tolerances for residues. (a) General. Tolerances are established for residues of the fungicide mandipropamid, 4-chloro-N-[2-(3methoxy-4-(2-propynyloxy)phenyl] ethyl]-alpha-(2-propynyloxy)benzeneacetamide in or on the following commodities. PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 Federal Emergency Management Agency, DHS. ACTION: Final rule. AGENCY: E:\FR\FM\16JAR1.SGM 16JAR1

Agencies

[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Rules and Regulations]
[Pages 2812-2816]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-677]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0461; FRL-8346-6]


Mandipropamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
alpha-(2-propynyloxy)-benzeneacetamide in or on Brassica, head and 
stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable, 
cucurbit, group 9; vegetable, fruiting, group 8; okra; vegetable, leafy 
except brassica, group 4; vegetable, tuberous and corm, subgroup 1C; 
grape; grape, raisin; onion, dry bulb; onion, green; and potato, wet 
peel. Syngenta Crop Protection Inc. requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 16, 2008. Objections and 
requests for hearings must be received on or before March 17, 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-2007-0461. 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: Rose Mary Kearns, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5611; e-mail address: 
kearns.rosemary@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-2007-0461 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 March 17, 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

[[Page 2813]]

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-2007-0461, 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 July 25, 2007 (72 FR 40877) (FRL-8137-1) 
and October 31, 2007 (72 FR 61637) (FRL 8154-8) EPA issued notices 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP7F7184 and 6F7057) by 
Syngenta Crop Protection Inc., P.O. Box 18300, Greensboro, NC 27419. 
The petition (6F7057) requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide mandipropamid, 4-
chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-
propynyloxy)-benzeneacetamide, in or on Brassica, head and stem, 
Subgroup 5A at 3 parts per million (ppm); Brassica, leafy greens, 
subgroup 5B at 30 ppm; vegetable, cucurbit, group 9 at .3 ppm; 
vegetable, fruiting, group 8 at 1 ppm; vegetable, leafy except 
Brassica, group 4 at 20 ppm; vegetable, tuberous and corm, subgroup 1C 
at 0.01 ppm; grape at 2 ppm; grape, raisin at 4 ppm; onion, dry bulb at 
0.05 ppm; onion, green at 4 ppm; and tomato paste at 1.3 ppm. That 
notice referenced a summary of the petition prepared by Syngenta Crop 
Protection, Inc., the registrant, which is available to the public in 
the docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.B..
    Based upon review of the data supporting the petition, EPA has 
recommended the inclusion of okra in Crop Group 8 (Vegetable, 
Fruiting). However, a separate tolerance for okra must be listed in the 
40 CFR 180.637, until the new crop group regulation is published. A 
tolerance for tomato paste was requested. However, the maximum expected 
residue in tomato paste and puree resulting from the proposed use will 
be covered by the recommended tolerance for vegetable, fruiting, crop 
group 8. A separate tolerance is being established for potato, wet 
peel, even though it was not requested. The maximum expected residue in 
potato, wet peel resulting from the proposed use is 0.03 ppm which was 
calculated by multiplying the HAFT of <0.01 ppm by the observed 
concentration factor of >3x. Potatoes have a separate tolerance under 
the vegetable, tuberous and corm subgroup 1C.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerance 
for residues of mandipropamid on Brassica, head and stem, subgroup 5A 
at 3 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; vegetable, 
cucurbit, group 9 at 0.6 ppm; vegetable, fruiting, group 8 at 1 ppm; 
okra at 1.0 ppm; vegetable, leafy except Brassica, group 4 at 20 ppm; 
vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; grape at 1.4 
ppm; grape, raisin at 3 ppm; onion, dry bulb at 0.05 ppm; onion, green 
at 4 ppm; and okra at 1 ppm and potato, wet peel at 0.03 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 mandipropamid 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 in the 
docket established by this action, which is described under ADDRESSES, 
and is identified as ``Mandipropamid: Human Health Risk Assessment for 
Proposed Uses'' 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

[[Page 2814]]

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/pesticides/
factsheets/riskassess.htm.
    A summary of the toxicological endpoints for mandipropamid used for 
human risk assessment is shown in Table 1 of this unit.

Table 1.--Summary of Toxicological Dose and Endpoints for Mandipropamid for Use in Dietary Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                          RfD, PAD, Level of       Study and
        Exposure/Scenario         Point of Departure   Uncertainty/FQPA    Concern for Risk      Toxicological
                                                        Safety Factors        Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General            N/A                 N/A                 N/A                 No appropriate
 Population, including Infants                                                                 endpoint was
 and Children)                                                                                 identified.
----------------------------------------------------------------------------------------------------------------
Acute Dietary(Females 13-49       N/A                 N/A                 N/A                 No appropriate
 years of age)                                                                                 endpoint was
                                                                                               identified.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All              NOAEL = 5 mg/kg/    UFA = 10X.........  Chronic RfD = 0.05  Chronic toxicity -
 Populations)                      day                UFH = 10X.........   mg/kg/day           dogs
                                                      FQPA SF = 1X......  cPAD = 0.05 mg/kg/  LOAEL = 40 mg/kg/
                                                                           day.                day, based on
                                                                                               evidence of liver
                                                                                               toxicity
                                                                                               (increased
                                                                                               incidence and
                                                                                               severity of
                                                                                               microscopic
                                                                                               pigment in the
                                                                                               liver and
                                                                                               increased
                                                                                               alkaline
                                                                                               phosphatase
                                                                                               activity in both
                                                                                               sexes as well as
                                                                                               increased alanine
                                                                                               aminotransferase
                                                                                               activity in
                                                                                               males).
----------------------------------------------------------------------------------------------------------------
Cancer                                             ``Not Likely to be Carcinogenic to Humans.''
                                    No treatment-related tumors observed in carcinogenicity studies in rats and
                                                   mice. A cancer risk assessment is not needed.
----------------------------------------------------------------------------------------------------------------
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose
  (c = chronic). RfD = reference dose. N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mandipropamid, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
mandipropamid 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 
mandipropamid; 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, 
or 1998; CSFII. As to residue levels in food, EPA relied upon tolerance 
level residues and percent crop treated (PCT) information for all 
commodities A unrefined chronic exposure assessment that assumes 100% 
crop treated was conducted for the proposed Section 3 uses of 
mandipropamid. The DEEM analysis incorporates estimates of drinking 
water concentrations from the Environmental Fate and Effects Division 
directly into the analysis. The chronic dietary exposure analysis for 
mandipropamid results in dietary risk estimates for food and water that 
are below the Agency's level of concern for chronic dietary exposure.
    iii. Cancer. There were no treatment-related tumors observed in 
carcinogenicity studies in rats and mice. Mandipropamid is classified 
as not likely to be a human carcinogen. Therefore, a cancer dietary 
exposure assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for mandipropamid 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 mandipropamid. 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 First Index Reservoir Screening Tool (FIRST), and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of mandipropamid for 
acute exposures are estimated to be 25.2 parts per billion (ppb) for 
surface water and 0.05 ppb for ground water. The EECs for the aquatic 
degradates SYN500003 and SYN504851 are estimated to be 2.32 and 8.99 
ppb for surface water and 0.6 and 1.7 ppb for ground water. The 
combined level of mandipropamid and the degradates in surface water is 
36.5 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the acute water concentration of value 36.5 ppb was used to 
conservatively 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).
    Mandipropamid 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

[[Page 2815]]

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 mandipropamid and any 
other substances and mandipropamid 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 mandipropamid 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 evidence 
(quantitative or qualitative) of increased susceptibility and no 
residual uncertainties with regard to prenatal toxicity following in 
utero exposure to rats or rabbits (developmental studies) and pre and/
or post-natal exposures to rats (reproduction study).
    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 toxicological database for mandipropamid is complete.
    ii. The toxicity data showed no increase in qualitative or 
quantitative susceptibility in fetuses and pups with in utero and post-
natal exposure.
    iii. The toxicity data indicates that there are no neurotoxic 
effects.
    iv. The dietary food exposure assessment is based on tolerance-
level residues and assumes 100% crop treated for all commodities, which 
results in very high-end estimates of dietary exposure.
    v. The dietary drinking water assessment is based on values 
generated by model and associated modeling parameters which are 
designed to provide conservative, health protective, high-end estimates 
of water concentrations.
    vi. No residential uses are proposed at this time.

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. No acute dietary endpoint based on effects 
attributable to a single dose could be identified based on the 
toxicology data currently available for mandipropamid. Therefore, 
mandipropamid is not expected to pose an acute risk.
    2. Chronic risk. There are no residential uses proposed or 
registered for mandipropamid, and therefore aggregate risk is equal to 
that from consumption of food and water. Chronic aggregate risk 
estimates associated with exposure to mandipropamid residues in food 
and water do not exceed the Agency's level of concern. For 
mandipropamid, the chronic dietary exposure estimate was 22% of the 
cPAD for the U.S. population and was 30% of the cPAD for the highest 
exposed population subgroup, children 1-2 years of age.
    3. Short-term and intermediate-term risk. Short and intermediate-
term dermal exposures and risks were not assessed for mandipropamid, 
since mandipropamid is not registered for use on any sites that would 
result in residential exposure.
    4. Aggregate cancer risk for U.S. population. Aggregate cancer risk 
was not assessed because mandipropamid is not likely to be carcinogenic 
in humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to mandipropamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology Analytical Method RAM 415/01 
Residue Analytical Method for the Determination of Mandipropamid in 
Crop Samples. Final Determination by LC/MS/MS and the Analytical Method 
Development and Validation (German S-19) for the determination of 
residues of MA Mandipropamid in or on Plant Matrices 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 specific CODEX, Canadian or Mexican maximum residue 
limits (MRLs) for mandipropamid.

C. General Response to Comments

    Several comments were received from a private citizen objecting to 
establishment of tolerances. The agency has received similar comments 
from this commenter on numerous previous occasions. Refer to Federal 
Register 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), 69 
FR 63096-63098 (October 29, 2004) for the Agency's response to these 
objections. In addition, the commenter noted several adverse effects 
seen in animal toxicology studies with mandipropamid and claims because 
of these effects no tolerance should be approved. EPA has found, 
however, that there is reasonable certainty of no harm to humans after 
considering these toxicological studies and the exposure levels of 
humans to mandipropamid.

V. Conclusion

    Therefore, the tolerances are established for residues of 
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
alpha-(2-propynyloxy)-benzeneacetamide, in or on Brassica, head and 
stem, subgroup 5A at 3 ppm; Brassica, leafy greens, subgroup 5B at 25 
ppm; vegetable, cucurbit, group 9 at 0.6 ppm; vegetable, fruiting, 
group 8 at 1.0 ppm; okra at 1.0 ppm; vegetable, leafy, except Brassica, 
group 4 at 20 ppm; vegetable, tuberous

[[Page 2816]]

and corm, subgroup 1C at 0.01 ppm; grape at 1.4 ppm; grape, raisin at 
3.0 ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 ppm; and 
potato, wet peel at 0.03 ppm. A tolerance for tomato paste is not being 
established because residue expected will be covered by the vegetable, 
fruiting crop group 8.

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: January 8, 2008.
Debra Edwards,
Director, 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 180.637 is added to read as follows:


Sec.  180.637  Mandipropamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide mandipropamid, 4-chloro-N-[2-(3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide in or 
on the following commodities.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.................                  3
Brassica, leafy greens, subgroup 5B..................                 25
Vegetable, cucurbit, group 9.........................                0.6
Vegetable, fruiting, group 8.........................                1.0
Vegetable, leafy except Brassica, group 4............                 20
Vegetable, tuberous and corm, subgroup 1C............               0.01
Grape................................................                1.4
Grape, raisin........................................                3.0
Okra.................................................                1.0
Onion, dry bulb......................................               0.05
Onion, green.........................................                  4
Potato, wet peel.....................................               0.03
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent tolerances. [Reserved]
[FR Doc. E8-677 Filed 1-15-08; 8:45 am]
BILLING CODE 6560-50-S