Famoxadone; Pesticide Tolerance, 28877-28881 [E7-9823]

Download as PDF Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations (b) Section 18 emergency exemptions. [Reserved] * * * * * [FR Doc. E7–9813 Filed 5–22–07; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–3194; e-mail address: brothers.shaja@epa.gov. 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 II. Petition for Tolerance In the Federal Register of May 10, 2006 (71 FR 27247) (FRL–8067–5) and November 22, 2006 (71 FR 67572) (FRL– 8101–9), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 5E7001 (grape and hop), and PP 6E7099 (caneberry) by the IR–4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions requested that 40 CFR 180.587 [EPA–HQ–OPP–2006–0332; FRL–8128–6] I. General Information Famoxadone; Pesticide Tolerance A. Does this Action Apply to Me? Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of famoxadone in or on grape, hop, and caneberry, Subgroup 13A. Interregional Research Project (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 23, 2007. Objections and requests for hearings must be received on or before July 23, 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– OPP–2006–0332. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket cprice-sewell on PROD1PC71 with RULES ADDRESSES: VerDate Aug<31>2005 15:35 May 22, 2007 Jkt 211001 e–CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2006–0332 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 23, 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–2006–0332, 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. SUPPLEMENTARY INFORMATION: AGENCY: 28877 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. PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\FR\FM\23MYR1.SGM 23MYR1 28878 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations cprice-sewell on PROD1PC71 with RULES be amended by establishing tolerances for residues of the fungicide famoxadone, 3-anilino-5-methyl-5-(4phenoxyphenyl)-1,3-oxazolidine-2,4dione, in or on grape (east of the rocky mountains) at 2.5 parts per million (ppm); hop, dried cone at 60 ppm; and caneberry at 11 ppm. These notices referenced a summary of the petitions prepared by Dupont, the registrant, which is available to the public in the docket, http://www.regulations.gov. A comment was received from a private citizen on the notice of filing for famoxadone on caneberry. EPA’s response to comment is discussed in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of the FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996. Consistent with 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 tolerances for residues of famoxadone grape (regional registration) at 2.5 ppm; hop, dried cone at 80 ppm; and caneberry subgroup 13A at 10 ppm on EPA’s assessment of exposures and risks associated with establishing the tolerances follow. 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 VerDate Aug<31>2005 15:35 May 22, 2007 Jkt 211001 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 famoxadone as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register at http:// www.epa.gov/EPA–PEST/2003/July/ Day–02/p16736.htm. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/ safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non–threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http:// www.epa.gov/fedrgstr/EPA–PEST/1997/ November/Day–26/p30948.htm. A summary of the toxicological endpoints for famoxadone can be found at www.regulations.gov in the Human Health Risk Assessment for PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 Famoxadone to Support Tolerances for Residues in/on Grapes, Hops, and Caneberry, Crop Subgroup 13A, pages 10–11 in Docket ID EPA–HQ–OPP– 2006–0332. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to famoxadone, EPA considered exposure under the petitioned-for tolerances as well as all existing famoxadone tolerances in (40 CFR 180.587). EPA assessed dietary exposures from famoxadone 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 famoxadone. Therefore, a quantitative acute dietary exposure assessment was not performed. 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 used Dietary Exposure Evaluation Model (DEEMTM) default processing factors and anticipated residues (ARs) calculated from field trial data including the highest average field trial (HAFT) level for hop and caneberry, and existing ARs for grape commodities. Exposure estimates were further refined with percent crop treated (PCT) data for several registered commodities. iii. Cancer. EPA has classified famoxadone as a ‘‘not likely’’ human carcinogen. Therefore, a cancer dietary exposure analysis was not performed. iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data CallIns as are required by section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance. E:\FR\FM\23MYR1.SGM 23MYR1 cprice-sewell on PROD1PC71 with RULES Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: a. The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; b. The exposure estimate does not underestimate exposure for any significant subpopulation group; and c. Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Tomato at 10%; Cucumber, Pepper, Potato, Pumpkin at 5%; Squash and Watermelon at 1%EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases <1% is used as the average and <2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent 6 years. The Agency believes that the three conditions listed have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA’s computer-based model for evaluating the exposure of VerDate Aug<31>2005 15:35 May 22, 2007 Jkt 211001 significant subpopulations including several regional groups. Use of this consumption information in EPA’s risk assessment process ensures that EPA’s exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which famoxadone may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for famoxadone 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 famoxadone. 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. The assessment was based on the registered potato use (highest application rate, 0.1875 lbs ai/acre, with 6 applications at 5 day intervals). The Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/ EXAMS) Model was used to estimate surface water concentrations, and Screening Concentrations in Groundwater (SCI-GROW) Model was used to estimate ground water concentrations. The model values generally represent upper-bound estimates of the concentrations that might be found in surface water and ground water resulting from the use of famoxadone. Based on the PRZM/EXAMS and SCIGROW models, the estimated environmental concentrations (EECs) of famoxadone for chronic exposures are estimated to be 0.47 ppb for surface water and 0.23 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 0.47 ppb was used to access the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 28879 indoor pest control, termiticides, and flea and tick control on pets). Famoxadone 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 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 famoxadone and any other substances and famoxadone 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 famoxadone has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at http:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (‘‘10X’’) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. There is no quantitative or qualitative evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure in developmental studies. There is no quantitative or qualitative evidence of increased susceptibility of rat offspring in the multi-generation reproduction study. E:\FR\FM\23MYR1.SGM 23MYR1 28880 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations cprice-sewell on PROD1PC71 with RULES 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for famoxadone is complete. ii. There is no indication that famoxadone is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity. iii. There is no evidence that famoxadone results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2–generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. Although the food exposure assessment was slightly refined, it is based in reliable data and will not underestimate the exposure and risk. Conservative ground water and surface water modeling estimates were used. These assessments will not underestimate the exposure and risks posed by famoxadone. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption and drinking water. There was no acute dietary endpoint selected. Therefore, famoxdane is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to famoxadone from food and water will utilize 65% of the cPAD for children 1-2 years old, the subpopulation group with the greatest exposure. There are no residential uses for famoxadone that result in chronic residential exposure to famoxadone. 3. Short and intermediate-term risks. Short and Intermediate-term aggregate exposures takes into account residential VerDate Aug<31>2005 15:35 May 22, 2007 Jkt 211001 exposure plus chronic exposure to food and water (considered to be a background exposure level). Famoxadone is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency’s level of concern. 4. Aggregate cancer risk for U.S. population. EPA has classified famoxadone as a ‘‘not likely’’ human carcinogen. Therefore, famoxdane is not expected to pose a cancer risk. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to famoxadone residues. IV. Other Considerations A. Analytical Enforcement Methodology An analytical method AMR 3705–95; gas chromatography with nitrogen/ phosphorus detector (GC/NPD) for plants was developed for data gathering and enforcement purposes to quantitate famoxadone. The method has undergone a successful independent laboratory validation (ILV) and Agency petition method validation (PMV). Therefore, adequate enforcement methodology is available to enforce this tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; e-mail address: residuemethods@epa.gov. B. International Residue Limits There are no established CODEX maximum residue limits (MRLs) for famoxadone. C. Response to Comments One comment was received by a private citizen. The commenter argued that cancer rates in the United States are too high and no new pesticides should be approved until the causes of the increased cancers are found. Additionally, the commenter urged that EPA should test famoxdane in combination with the thousands of other chemicals to which humans are exposed. Famoxdane has been examined in the required carcinogenicity studies and EPA concluded that it is not likely to be carcinogenic to humans. This was discussed in a prior rulemaking published in the Federal Register at http://www.epa.gov/EPA-PEST/2003/ July/Day-02/p16736.htm. EPA does not PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 require the testing of pesticides in combination with other chemicals but does consider available data bearing on whether a pesticide shares a common toxicity with other substances that could result in cumulative effects. For specific information regarding EPA’s approach to the use of common mechanism of toxicity to evaluate the cumulative effects of chemicals, please refer to EPA’s website at http:// www.epa.gov/pesticides/cumulative to see policy statements. V. Conclusion The proposed tolerance for hop, dried cone was requested at 60 ppm. The residue data from the hop field trials indicate that residues of famoxadone ranged from 14.70 ppm to 46.85 ppm in/ on dried hops harvested 7-8 days after the last of six applications at a total rate of ~1.50 lb ai/A. The submitted data are adequate pending label revision to reflect the parameters of field trial data. The Agency recommends the following label revisions: apply a maximum single foliar application rate of 0.25 lb ai/A, with a 6-8 day RTI, a maximum seasonal rate of ~1.50 lb ai/A, and a 7–day PHI. Statistical analysis of the data show that a tolerance level of 80 ppm will be appropriate for hops. The proposed tolerance for caneberry, subgroup 13-A was requested at 11 ppm. The results from these trials show that famoxadone residues ranged from 0.40 ppm to 6.7 ppm on/in treated caneberry when the test substance was applied at the proposed seasonal application rate of 1.125 lb ai/A using a 0–day PHI. Caneberry were stored frozen for a maximum of 181 days at –21°9C. Submitted storage stability studies indicate that famoxadone residues are stable on caneberry for up to 216 days. A residue decline study was not conducted by the applicant. Statistical analysis of the data show that a tolerance level of 10 ppm will be appropriate for caneberry, subgroup 13A. Therefore, the tolerances are established for residues of famoxadone, 3-anilino-5-methyl-5-(4phenoxyphenyl)-1,3-oxazolidine-2,4dione), in or on grape (regional registration) at 2.5 ppm; hop, dried cone at 80 ppm; and caneberry, Subgroup 13A at 10 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive E:\FR\FM\23MYR1.SGM 23MYR1 cprice-sewell on PROD1PC71 with RULES Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 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) (Pub. L. 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 VerDate Aug<31>2005 15:35 May 22, 2007 Jkt 211001 (NTTAA), Pub. L. 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. 28881 fungicide famoxadone, 3-anilino-5methyl-5-(4-phenoxyphenyl)-1,3oxazolidine-2,4-dione) in or on the raw agricultural commodities: Commodity Parts per million Grape .............................. * * * * 2.5 * [FR Doc. E7–9823 Filed 5–22–07; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–0586; FRL–8126–6] Propanil, Phenmedipham, Triallate, and MCPA; Tolerance Actions Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: EPA is revoking certain tolerances for the herbicides propanil, triallate, and MCPA. EPA is modifying certain tolerances for the herbicides propanil, phenmedipham, triallate, and MCPA. In addition, EPA is establishing I Therefore, 40 CFR chapter I is tolerances for the herbicides propanil, amended as follows: phenmedipham, triallate, and MCPA. The regulatory actions in this document PART 180—AMENDED are part of the Agency’s reregistration program under the Federal Food, Drug, I 1. The authority citation for part 180 and Cosmetic Act (FFDCA) section continues to read as follows: 408(q), as amended by the Food Quality Authority: 21 U.S.C. 321(q), 346a and 371. Protection Act (FQPA) of 1996. I 2. Section 180.587 is amended by DATES: This regulation is effective May revising the section heading; by 23, 2007. Objections and requests for alphabetically adding caneberry, hearings must be received on or before Subgroup 13A and hop, dried cone to July 23, 2007, and must be filed in the table in paragraph (a) and removing accordance with the instructions grape from the table in paragraph (a); provided in 40 CFR part 178 (see also and adding text to paragraph (c) to read Unit I.C. of the SUPPLEMENTARY as follows: INFORMATION). ADDRESSES: EPA has established a § 180.587 Famoxadone; tolerance for docket for this action under docket residues. identification (ID) number EPA–HQ– (a) * * * OPP–2006–0586. To access the electronic docket, go to http:// Commodity Parts per million www.regulations.gov, select ‘‘Advanced Caneberry, Subgroup Search,’’ then ‘‘Docket Search.’’ Insert 13A .............................. 10 the docket ID number where indicated * * * * * and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov Hop, dried cone .............. 80 web site to view the docket index or * * * * * access available documents. All documents in the docket are listed in 1There are no U.S. registrations as of May the docket index available in 15,2003. regulations.gov. Although listed in the index, some information is not publicly * * * * * available, e.g., Confidential Business (c) Tolerances with a regional registrations. Tolerances with a regional Information (CBI) or other information whose disclosure is restricted by statute. registration as defined in Sec. 180.1(n) Certain other material, such as are established for the residues of the Dated: May 15, 2007. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 E:\FR\FM\23MYR1.SGM 23MYR1

Agencies

[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Rules and Regulations]
[Pages 28877-28881]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9823]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0332; FRL-8128-6]


Famoxadone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
famoxadone in or on grape, hop, and caneberry, Subgroup 13A. 
Interregional Research Project (IR-4) requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 23, 2007. Objections and 
requests for hearings must be received on or before July 23, 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-2006-0332. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2006-0332 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 23, 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-2006-0332, 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 May 10, 2006 (71 FR 27247) (FRL-8067-5) 
and November 22, 2006 (71 FR 67572) (FRL-8101-9), EPA issued notices 
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions PP 5E7001 (grape and hop), 
and PP 6E7099 (caneberry) by the IR-4, 500 College Road East, Suite 201 
W, Princeton, NJ 08540. The petitions requested that 40 CFR 180.587

[[Page 28878]]

be amended by establishing tolerances for residues of the fungicide 
famoxadone, 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-
dione, in or on grape (east of the rocky mountains) at 2.5 parts per 
million (ppm); hop, dried cone at 60 ppm; and caneberry at 11 ppm. 
These notices referenced a summary of the petitions prepared by Dupont, 
the registrant, which is available to the public in the docket, http://
www.regulations.gov. A comment was received from a private citizen on 
the notice of filing for famoxadone on caneberry. EPA's response to 
comment is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to the FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with 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 tolerances 
for residues of famoxadone grape (regional registration) at 2.5 ppm; 
hop, dried cone at 80 ppm; and caneberry subgroup 13A at 10 ppm on 
EPA's assessment of exposures and risks associated with establishing 
the tolerances follow.

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 famoxadone as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register at http://www.epa.gov/EPA-PEST/2003/
July/Day-02/p16736.htm.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) are 
used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable uncertainty/safety factors. Short-, intermediate, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the margin of exposure (MOE) called for by the product of 
all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for famoxadone can be 
found at www.regulations.gov in the Human Health Risk Assessment for 
Famoxadone to Support Tolerances for Residues in/on Grapes, Hops, and 
Caneberry, Crop Subgroup 13A, pages 10-11 in Docket ID EPA-HQ-OPP-2006-
0332.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to famoxadone, EPA considered exposure under the petitioned-
for tolerances as well as all existing famoxadone tolerances in (40 CFR 
180.587). EPA assessed dietary exposures from famoxadone 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 famoxadone. Therefore, a 
quantitative acute dietary exposure assessment was not performed.
    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 used Dietary Exposure 
Evaluation Model (DEEM\TM\) default processing factors and anticipated 
residues (ARs) calculated from field trial data including the highest 
average field trial (HAFT) level for hop and caneberry, and existing 
ARs for grape commodities. Exposure estimates were further refined with 
percent crop treated (PCT) data for several registered commodities.
    iii. Cancer. EPA has classified famoxadone as a ``not likely'' 
human carcinogen. Therefore, a cancer dietary exposure analysis was not 
performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must pursuant to section 408(f)(1) 
require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such Data Call-Ins as are required by section 
408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. 
Data will be required to be submitted no later than 5 years from the 
date of issuance of this tolerance.

[[Page 28879]]

    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    a. The data used are reliable and provide a valid basis to show 
what percentage of the food derived from such crop is likely to contain 
such pesticide residue;
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group; and
    c. Data are available on pesticide use and food consumption in a 
particular area, the exposure estimate does not understate exposure for 
the population in such area. In addition, the Agency must provide for 
periodic evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by section 408(b)(2)(F) 
of FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Tomato at 10%; Cucumber, Pepper, Potato, Pumpkin at 5%; Squash and 
Watermelon at 1%EPA uses an average PCT for chronic dietary risk 
analysis. The average PCT figure for each existing use is derived by 
combining available federal, state, and private market survey data for 
that use, averaging by year, averaging across all years, and rounding 
up to the nearest multiple of five percent except for those situations 
in which the average PCT is less than one. In those cases <1% is used 
as the average and <2.5% is used as the maximum. EPA uses a maximum PCT 
for acute dietary risk analysis. The maximum PCT figure is the single 
maximum value reported overall from available federal, state, and 
private market survey data on the existing use, across all years, and 
rounded up to the nearest multiple of five percent. In most cases, EPA 
uses available data from United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary 
Market Surveys, and the National Center for Food and Agriculture Policy 
(NCFAP) for the most recent 6 years.
    The Agency believes that the three conditions listed have been met. 
With respect to Condition 1, PCT estimates are derived from Federal and 
private market survey data, which are reliable and have a valid basis. 
The Agency is reasonably certain that the percentage of the food 
treated is not likely to be an underestimation. As to Conditions 2 and 
3, regional consumption information and consumption information for 
significant subpopulations is taken into account through EPA's 
computer-based model for evaluating the exposure of significant 
subpopulations including several regional groups. Use of this 
consumption information in EPA's risk assessment process ensures that 
EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which famoxadone may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for famoxadone 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 
famoxadone. 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.
    The assessment was based on the registered potato use (highest 
application rate, 0.1875 lbs ai/acre, with 6 applications at 5 day 
intervals). The Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) Model was used to estimate surface water 
concentrations, and Screening Concentrations in Groundwater (SCI-GROW) 
Model was used to estimate ground water concentrations. The model 
values generally represent upper-bound estimates of the concentrations 
that might be found in surface water and ground water resulting from 
the use of famoxadone.
    Based on the PRZM/EXAMS and SCI-GROW models, the estimated 
environmental concentrations (EECs) of famoxadone for chronic exposures 
are estimated to be 0.47 ppb for surface water and 0.23 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 0.47 ppb was used to 
access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Famoxadone 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 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 famoxadone and any other 
substances and famoxadone 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 famoxadone has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the data base on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional FQPA safety factor value based on the use of 
traditional uncertainty/safety factors and/or special FQPA safety 
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no quantitative or 
qualitative evidence of increased susceptibility of rat and rabbit 
fetuses to in utero exposure in developmental studies. There is no 
quantitative or qualitative evidence of increased susceptibility of rat 
offspring in the multi-generation reproduction study.

[[Page 28880]]

    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for famoxadone is complete.
    ii. There is no indication that famoxadone is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional uncertainty factors to account for neurotoxicity.
    iii. There is no evidence that famoxadone results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. Although the food exposure assessment was slightly refined, 
it is based in reliable data and will not underestimate the exposure 
and risk. Conservative ground water and surface water modeling 
estimates were used. These assessments will not underestimate the 
exposure and risks posed by famoxadone.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability 
of additional cancer cases given aggregate exposure. Short-, 
intermediate, and long-term risks are evaluated by comparing aggregate 
exposure to the LOC to ensure that the MOE called for by the product of 
all applicable uncertainty/safety factors is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption and drinking 
water. There was no acute dietary endpoint selected. Therefore, 
famoxdane is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
famoxadone from food and water will utilize 65% of the cPAD for 
children 1-2 years old, the subpopulation group with the greatest 
exposure. There are no residential uses for famoxadone that result in 
chronic residential exposure to famoxadone.
    3. Short and intermediate-term risks. Short and Intermediate-term 
aggregate exposures takes into account residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level).
    Famoxadone is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    4. Aggregate cancer risk for U.S. population. EPA has classified 
famoxadone as a ``not likely'' human carcinogen. Therefore, famoxdane 
is not expected to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to famoxadone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method AMR 3705-95; gas chromatography with nitrogen/
phosphorus detector (GC/NPD) for plants was developed for data 
gathering and enforcement purposes to quantitate famoxadone. The method 
has undergone a successful independent laboratory validation (ILV) and 
Agency petition method validation (PMV). Therefore, adequate 
enforcement methodology is available to enforce this tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no established CODEX maximum residue limits (MRLs) for 
famoxadone.

C. Response to Comments

    One comment was received by a private citizen. The commenter argued 
that cancer rates in the United States are too high and no new 
pesticides should be approved until the causes of the increased cancers 
are found. Additionally, the commenter urged that EPA should test 
famoxdane in combination with the thousands of other chemicals to which 
humans are exposed. Famoxdane has been examined in the required 
carcinogenicity studies and EPA concluded that it is not likely to be 
carcinogenic to humans. This was discussed in a prior rulemaking 
published in the Federal Register at http://www.epa.gov/EPA-PEST/2003/
July/Day-02/p16736.htm. EPA does not require the testing of pesticides 
in combination with other chemicals but does consider available data 
bearing on whether a pesticide shares a common toxicity with other 
substances that could result in cumulative effects. For specific 
information regarding EPA's approach to the use of common mechanism of 
toxicity to evaluate the cumulative effects of chemicals, please refer 
to EPA's website at http://www.epa.gov/pesticides/cumulative to see 
policy statements.

V. Conclusion

    The proposed tolerance for hop, dried cone was requested at 60 ppm. 
The residue data from the hop field trials indicate that residues of 
famoxadone ranged from 14.70 ppm to 46.85 ppm in/on dried hops 
harvested 7-8 days after the last of six applications at a total rate 
of ~1.50 lb ai/A. The submitted data are adequate pending label 
revision to reflect the parameters of field trial data. The Agency 
recommends the following label revisions: apply a maximum single foliar 
application rate of 0.25 lb ai/A, with a 6-8 day RTI, a maximum 
seasonal rate of ~1.50 lb ai/A, and a 7-day PHI. Statistical analysis 
of the data show that a tolerance level of 80 ppm will be appropriate 
for hops.
    The proposed tolerance for caneberry, subgroup 13-A was requested 
at 11 ppm. The results from these trials show that famoxadone residues 
ranged from 0.40 ppm to 6.7 ppm on/in treated caneberry when the test 
substance was applied at the proposed seasonal application rate of 
1.125 lb ai/A using a 0-day PHI. Caneberry were stored frozen for a 
maximum of 181 days at -21[deg]9C. Submitted storage stability studies 
indicate that famoxadone residues are stable on caneberry for up to 216 
days. A residue decline study was not conducted by the applicant. 
Statistical analysis of the data show that a tolerance level of 10 ppm 
will be appropriate for caneberry, subgroup 13-A.
    Therefore, the tolerances are established for residues of 
famoxadone, 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-
dione), in or on grape (regional registration) at 2.5 ppm; hop, dried 
cone at 80 ppm; and caneberry, Subgroup 13A at 10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive

[[Page 28881]]

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) (Pub. L. 
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), Pub. L. 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 15, 2007.
Daniel J. Rosenblatt,
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 180.587 is amended by revising the section heading; by 
alphabetically adding caneberry, Subgroup 13A and hop, dried cone to 
the table in paragraph (a) and removing grape from the table in 
paragraph (a); and adding text to paragraph (c) to read as follows:


Sec.  180.587  Famoxadone; tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Caneberry, Subgroup 13A..............................                 10
                                * * * * *
Hop, dried cone......................................                 80
                               * * * * *
------------------------------------------------------------------------
1There are no U.S. registrations as of May 15,2003.

* * * * *
    (c) Tolerances with a regional registrations. Tolerances with a 
regional registration as defined in Sec. 180.1(n) are established for 
the residues of the fungicide famoxadone, 3-anilino-5-methyl-5-(4-
phenoxyphenyl)-1,3-oxazolidine-2,4-dione) in or on the raw agricultural 
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Grape................................................                2.5
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-9823 Filed 5-22-07; 8:45 am]
BILLING CODE 6560-50-S