Rules and Regulations. Final rule

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BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0105; FRL-8340-6] Acetamiprid; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of acetamiprid in or on almond, hulls; fruit, stone, group 12, except plum, prune; nut, tree, group 14; pea and bean, succulent shelled, subgroup 6B; pistachio; plum, prune, dried; plum, prune, fresh; vegetable, cucurbit, group 9; and vegetable, legume, edible podded, subgroup 6A.

Nippon Soda Co., Ltd. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 28, 2007. Objections and requests for hearings must be received on or before January 28, 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-2007-0105. 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: Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-5218; e-mail address: *stanton.susan@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-2007-0105 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 January 28, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0105, 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 September 15, 2004 (69 FR 55625) (FRL-7674-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F6833) by Nippon Soda Co., Ltd., c/o Nisso America Inc., 220 East 42nd Street, Suite 3002, New York, NY, 10017. The petition requested that 40 CFR 180.578 be amended by establishing tolerances for residues of the insecticide acetamiprid, N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine, in or on the cucurbit crop group at 0.5 parts per million (ppm); the stone fruit crop group, except plum, prune, fresh and dried at 1.2 ppm; plum, prune, fresh and dried at 0.3 ppm; the tree nut crop group, except almond hulls at 0.1 ppm; and almond hulls at 5.0 ppm. That notice included a summary of the petition prepared by Nippon Soda Co., Ltd., the registrant, which is available to the public in the docket ID Number EPA-HQ-OPP-2004-0223, *http://www.regulations.gov* . Comments were received on the notice of filing from a private citizen. EPA's response to these comments is discussed in Unit IV.C below. In the **Federal Register** of September 22, 2006 (71 FR 55468) (FRL-8091-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7051) by Nippon Soda Co., Ltd., c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY, 10006. The petition requested that 40 CFR 180.578 be amended by establishing tolerances for residues of the insecticide acetamiprid, N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine, in or on bulb vegetables crop group 3 at 3 ppm; edible podded legume vegetables, crop subgroup 6a at 0.5 ppm; succulent shelled pea and beans, crop subgroup 6b, at 0.5 ppm; and berries, crop group 13 at 1 ppm. The notice also announced the filing of amended pesticide petition 4F6833, requesting a tolerance for residues of acetamiprid in or on pistachio at 0.1 ppm in addition to the tolerances described in the preceding paragraph. That notice referenced a summary of the petition prepared by Nippon Soda Co., Ltd., the registrant, which is available to the public in the docket ID Number EPA-HQ-OPP-2006-0733, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. EPA is deferring to a later date the decision regarding the proposed tolerances for residues of acetamiprid on bulb vegetables crop group 3 and berry crop group 13. Based upon review of the data supporting the petitions, EPA has modified the tolerance levels and/or commodity terms for several of the other proposed tolerances. The reasons for these changes are explained in Unit V. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” These provisions were added to FFDCA by the Food Quality Protection Act

(FQPA)of 1996. Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of acetamiprid on Almond, hulls at 5.0 ppm; Fruit, stone, group 12, except plum, prune at 1.20 ppm; Nut, tree, group 14 at 0.10 ppm; Pea and bean, succulent shelled, subgroup 6B at 0.40 ppm; Pistachio at 0.10 ppm; Plum, prune, dried at 0.40 ppm; Plum, prune, fresh at 0.20 ppm; Vegetable, cucurbit, group 9 at 0.50 ppm; and Vegetable, legume, edible podded, subgroup 6A at 0.60 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 acetamiprid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* in the document *Acetamiprid: Human Health Risk Assessment for Proposed Food Uses on Stone Fruits, Cucurbit Vegetables, Tree Nuts, Berries, Strawberries, Bulb Vegetables, Legumes (Peas and Beans) and for Residential/Commercial Insecticide/Termiticide Uses* . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as document ID number EPA-HQ-OPP-2007-0105-0003 in that docket. The toxicity database for acetamiprid is complete. The acute toxicity data indicate that acetamiprid is moderately toxic via the oral route and is minimally toxic via the dermal and inhalation routes. Acetamiprid is not an eye or skin irritant, and it is not a dermal sensitizer. Based on subchronic, chronic, developmental and reproductive studies in rats, rabbits, and dogs, acetamiprid does not appear to have specific target organ toxicity. Generalized nonspecific toxicity was observed as decreases in body weight, body weight gain, food consumption and food efficiency when determined. Generalized effects were also observed in the liver in the form of hepatocellular hypertrophy in both mice and rats and hepatocellular vacuolation in the rat. The hepatocellular hypertrophy in mice is considered to be adaptive; it is likely that the vacuolization in rats is more related to liver activity in response to the presence of the chemical rather than frank toxicity. Neurotoxicity was observed in the form of decreased locomotor activity in the acute neurotoxicity study in rats and as decreased auditory startle response in the developmental neurotoxicity study in rats. Developmental studies showed no evidence of either quantitative or qualitative susceptibility of the rat or rabbit fetuses from *in utero* exposure. However, both the developmental neurotoxicity

(DNT)study and the multi-generation reproduction studies showed an increase in qualitative susceptibility of pups. Effects in pups in the reproduction study included delays in preputial separation, vaginal opening and pinna unfolding as well as reduced litter size, decreased early pup viability and weaning indices; offspring effects observed in the DNT study included decreased body weight and body weight gains, decreased early pup viability and decreased maximum auditory startle response in males. These effects were seen in the presence of less severe effects (decreased body weight and body weight gain) in the maternal animals. Based on acceptable carcinogenicity studies in rats and mice, EPA has determined that acetamiprid is not likely to be carcinogenic to humans. This determination is based on the absence of a dose-response or statistical significance for the increased incidence in mammary adenocarcinomas observed in the rat carcinogenicity study, as well as the lack of evidence of carcinogenic effects in the mouse cancer study. 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 the NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, 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-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure

(MOE)called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/pesticides/factsheets/riskassess.htm* . A summary of the toxicological endpoints for acetamiprid used for human risk assessment can be found at *http://www.regulations.gov* at pages 21-22 in the document *Acetamiprid: Human Health Risk Assessment for Proposed Food Uses on Stone Fruits, Cucurbit Vegetables, Tree Nuts, Berries, Strawberries, Bulb Vegetables, Legumes (Peas and Beans) and for Residential/Commercial Insecticide/Termiticide Uses* in docket ID number EPA-HQ-OPP-2007-0105. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to acetamiprid, EPA considered exposure under the petitioned-for tolerances as well as all existing acetamiprid tolerances in (40 CFR 180.578). EPA assessed dietary exposures from acetamiprid in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. In estimating acute dietary exposure to acetamiprid, EPA used food consumption information from the U.S. Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA relied upon anticipated residues derived from field trial data for certain commodities (apples; broccoli; cabbage, celery; grapefruit; grapes; lettuce; oranges; pears; peppers; spinach; tomatoes; stone fruits; and cucurbits) and assumed residues were present at tolerance levels in all other commodities. EPA also relied on percent crop treated

(PCT)information for some of the currently registered commodities (apples, broccoli , celery, lettuce, pears, grapefruit, grapes, oranges, peppers, spinach and tomatoes) but assumed 100 PCT for all of the new commodities. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances or for which tolerances are being established contain tolerance-level residues. EPA relied on PCT information for two currently registered crops (apples and oranges) but assumed 100 PCT for all other commodities. iii. *Cancer* . As noted above, EPA has determined that acetamiprid is not likely to be carcinogenic to humans. Therefore, an exposure assessment for use in a quantitative cancer risk assessment is unnecessary. 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) of FFDCA 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. 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. 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: For the acute assessment, maximum PCT estimates were used for the following commodities: Apples (15%), broccoli (5%), celery (15%), lettuce (10%), pears (25%), and grapefruit, grapes, oranges, peppers, spinach and tomatoes, each at 2.5%. For the chronic assessment, average PCT estimates were used for the following commodities: Apples (10%) and oranges (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 5% 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 5%. In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent six years. The Agency believes that the three conditions listed in this unit have been met. With respect to Condition A, 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 B and C, 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 acetamiprid 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 acetamiprid 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 acetamiprid. 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 acetamiprid for acute exposures are estimated to be 20.1 parts per billion

(ppb)for surface water and 1.6 ppb for ground water. The EECs for chronic exposures are estimated to be 4.9 ppb for surface water and 1.6 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 20.1 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 4.9 ppb was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Acetamiprid is currently registered for the following residential non-dietary sites: As a pre- and post-construction termiticide/insecticide for use in subterranean or hard-to-reach structure components and building perimeters; and as a crack, crevice or spot application using gel bait formulations for control of ants and cockroaches in residential settings. EPA assessed residential exposure using the following assumptions: The pre- and post-construction termiticide/insecticide uses of acetamiprid are limited to licensed Pest Control Operators (PCOs); therefore, homeowner handler exposures are not expected to occur. Nor are post-application exposures of adults or children expected as a result of these uses, since applications are limited to subterranean or hard-to-reach structure components and building perimeters. EPA has determined that short-term and intermediate-term dermal exposure of residential handlers may occur from use of the gel bait formulations in residential settings; however, due to the low vapor pressure of acetamiprid and its formulation as a gel, inhalation exposure of handlers is not expected. Post-application exposures of adults and children from this use are expected to be negligible for the following reasons:

(i)Homeowners are unlikely to revisit the crack, crevice or spot where the gel bait has been applied, thereby minimizing potential exposure;

(ii)inhalation exposure is expected to be minimal due to acetamiprid's low vapor pressure and its formulation as a gel; and

(iii)the gel bait products contain a bittering agent which is used to prevent ingestion by children and animals, thereby further reducing potential for incidental oral exposures of children. For these reasons, EPA assessed only residential handler dermal exposures from the gel bait uses of acetamiprid. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Acetamiprid is a member of the neonicotinoid class of pesticides which also includes thiamethoxam, clothianidin, imidacloprid and several other active ingredients. Structural similarities or common effects do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events. Although the neonicotinoids bind selectively to insect nicotinic acetylcholine receptors (nAChR), the specific binding site(s)/receptor(s) are unknown at this time. Additionally, the commonality of the binding activity itself is uncertain, as preliminary evidence suggests that clothianidin operates by direct competitive inhibition, while thiamethoxam is a non-competitive inhibitor. Furthermore, even if future research shows that neonicotinoids share a common binding activity to a specific site on insect nicotinic acetylcholine receptors, there is not necessarily a relationship between this pesticidal action and a mechanism of toxicity in mammals. Structural variations between the insect and mammalian nAChRs produce quantitative differences in the binding affinity of the neonicotinoids towards these receptors, which, in turn, confers the notably greater selective toxicity of this class towards insects, including aphids and leafhoppers, compared to mammals. Additionally, the most sensitive toxicological effect in mammals differs across the neonicotinoids (e.g., testicular tubular atrophy with thiamethoxam; mineralized particles in thyroid colloid with imidaclopid). Thus, there is currently no evidence to indicate that neonicotinoids share common mechanisms of toxicity, and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the neonicotinoids. In addition, acetamiprid does not appear to produce a toxic metabolite produced by other substances. Therefore, for the purposes of this tolerance action, EPA has not assumed that acetamiprid has a common mechanism of toxicity with other substances. For more 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* . The pre- and postnatal toxicology database for acetamiprid includes rat and rabbit developmental toxicity studies, a 2-generation reproduction toxicity study in rats and a DNT study in rats. There was no evidence of quantitative or qualitative susceptibility of rat or rabbit fetuses following *in utero* exposure to acetamiprid in the developmental toxicity studies. However, both the DNT and multi-generation reproduction studies showed an increase in qualitative susceptibility of pups. Effects in pups in the reproduction study included delays in preputial separation, vaginal opening and pinna unfolding, as well as reduced litter size, decreased early pup viability and weaning indices; offspring effects observed in the DNT study included decreased body weight and body weight gains, decreased early pup viability and decreased maximum auditory startle response in males. These effects were seen in the presence of decreased body weight and body weight gain in the maternal animals, indicating increased qualitative susceptibility of fetuses and offspring to acetamiprid. Quantitative evidence of increased susceptibility was not observed in any study. In considering the overall toxicity profile and the endpoints and doses selected for the acetamiprid risk assessment, EPA characterized the degree of concern for the effects observed in the acetamiprid DNT and the 2-generation reproduction study as low, noting that there is a clear NOAEL for the offspring effects in both studies, the toxicology database is complete, and regulatory doses were selected to be protective of potential offspring effects in both the DNT and the 2-generation study. No other residual uncertainties were identified. Based on the available data, EPA determined that changes in motor activity, auditory startle reflex, learning and memory assessments, and even changes in the brain morphometrics can occur as the result of a single exposure at a critical junction during pregnancy or from multiple exposures throughout pregnancy and lactation. Therefore, the NOAEL for offspring effects observed in the DNT was selected as the dose for acute dietary exposures (co-critical with the acute neurotoxicity study), as well as short-term and intermediate-term non-dietary risk assessment. Use of the DNT NOAEL is protective of effects seen in the 2-generation study (the NOAEL from the DNT is 10.0 mg/kg/day and the NOAEL from the 2-generation study is 17.9 mg/kg/day). The chronic dietary study in rats yielded a lower long-term NOAEL (7.1 mg/kg/day) and was, therefore, used for assessing chronic dietary risk. EPA believes that the endpoints and doses selected for acetamiprid are protective of adverse effects in both offspring and adults. 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 acetamiprid is complete. ii. There is no evidence that acetamiprid results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies. Although there is qualitative evidence of increased susceptibility in the multi-generation reproduction study and in the DNT study, the risk assessment team did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of acetamiprid. The degree of concern for pre- and/or postnatal toxicity is low. iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on tolerance-level residues or anticipated residues derived from reliable field trial data. The PCT estimates used in the dietary assessment were derived from valid, reliable Federal and private market survey data and are unlikely to be exceeded. Conservative ground and surface water modeling estimates were used to assess exposures to acetamiprid from drinking water; and residential, non-dietary exposure of infants and children to acetamiprid is not expected to occur. EPA believes these assessments will not underestimate the exposure and risks posed by acetamiprid. 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-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to acetamiprid will occupy 35% of the aPAD for children 1 to 2 years old, the population group receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to acetamiprid from food and water will utilize 35% of the cPAD for children 1 to 2 years old, the population group with greatest exposure. Based on the use pattern, chronic residential exposure to residues of acetamiprid is not expected. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acetamiprid is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for acetamiprid. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of 900 for adults 20 to 49 years old and 930 for adults 50 years and older who apply gel bait acetamiprid products for ant and cockroach control. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acetamiprid is currently registered for use that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for acetamiprid. Since the short-term and intermediate-term dermal exposures and endpoints for acetamiprid are the same, intermediate-term aggregate MOEs for adult residential handlers are the same as the short-term aggregate MOEs reported above (900 to 930). 5. *Aggregate cancer risk for U.S. population* . EPA has classified acetamiprid as “Not likely to be carcinogenic to humans. Acetamiprid is not expected to pose a cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to acetamiprid residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate residue analytical methods are available for the enforcement of established and new tolerances for plant commodities (gas chromotography /electron capture detector and high performance liquid chromotography/ultra violet detection (GC/ECD and HPLC/UV) and animal commodities (HPLC/UV)). These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no Codex, Canadian or Mexican maximum residue levels

(MRLs)established on the commodities associated with these petitions. C. Response to Comments Comments were received from a private citizen objecting to establishing these tolerances or any exemptions for acetamiprid or approval of its sale. The commenter objected to acetamiprid residues in food as well as EPA's reliance on animal testing on the basis that animal tests are inhumane and not relevant to human toxicity. The Agency has received these same or 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), and 69 FR 63096 (October 29, 2004) for the Agency's response to these objections. V. Conclusion Based upon review of the data supporting the petitions, EPA has modified the proposed tolerances as follows:

(1)PP 4F6833: Modified the commodity terms for stone fruit, tree nuts and cucurbit vegetables to agree with recommended commodity terms in the Office of Pesticide Program's Food and Feed Commodity Vocabulary (Fruit, stone, group 12, except plum, prune; Nut, tree, group 14; and Vegetable, cucurbit, group 9); and modified the commodity terms and established separate tolerances for Plum, prune, dried at 0.40 ppm and Plum, prune, fresh at 0.20 ppm (fresh) based on the field trial results showing different residues in the dried and fresh forms.

(2)PP 6F7051: Revised the commodity terms and tolerance levels for edible podded legumes and succulent shelled peas and beans to read “Vegetable, legume, edible podded, subgroup 6A” at 0.60 ppm and “Pea and bean, succulent shelled, subgroup 6B” at 0.40 ppm. EPA revised these tolerance levels based on analyses of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data Standard Operating Procedure (SOP). EPA is deferring to a later date the decision regarding the proposed tolerances for residues of acetamiprid on bulb vegetables crop group 3 and berry crop group 13. Therefore, tolerances are established for residues of acetamiprid, N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine, in or on Almond, hulls at 5.0 ppm; Fruit, stone, group 12, except plum, prune at 1.20 ppm; Nut, tree, group 14 at 0.10 ppm; Pea and bean, succulent shelled, subgroup 6B at 0.40 ppm; Pistachio at 0.10 ppm; Plum, prune, dried at 0.40 ppm; Plum, prune, fresh at 0.20 ppm; Vegetable, cucurbit, group 9 at 0.50 ppm; and Vegetable, legume, edible podded, subgroup 6A at 0.60 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 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: November 14, 2007. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.578 is amended by alphabetically adding the following commodities to the table in paragraph (a)(1) to read as follows: § 180.578 Acetamiprid; tolerances for residues.

(a)*General* . * * *

(1)* * * Commodity Parts per million Almond, hulls 5.0 * * * * * Fruit, stone, group 12, except plum, prune 1.20 * * * * * Nut, tree, group 14 0.10 Pea and bean, succulent shelled, subgroup 6B 0.40 Pistachio 0.10 Plum, prune, dried 0.40 Plum, prune, fresh 0.20 * * * * * Vegetable, cucurbit, group 9 0.50 * * * * * Vegetable, legume, edible podded, subgroup 6A 0.60 * * * * * [FR Doc. E7-23055 Filed 11-27-07; 8:45 am] BILLING CODE 6560-50-S 72 228 Wednesday, November 28, 2007 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-0254; Directorate Identifier 2007-NM-209-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 777 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive

(AD)for certain Boeing Model 777 airplanes. This proposed AD would require installing software upgrades to the airplane information management system

(AIMS)located in the flight compartment. This proposed AD results from an investigation that revealed that detrimental effects could occur on certain AIMS software during flight. We are proposing this AD to prevent an unannunciated loss of cabin pressure. If an undetected loss of pressure event were to cause an unsafe pressure in the cabin, the flight crew could become incapacitated. DATES: We must receive comments on this proposed AD by January 14, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Fax:* 202-493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Jay Yi, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone

(425)917-6494; fax

(425)917-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-0254; Directorate Identifier 2007-NM-209-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion An investigation of a service problem revealed that detrimental effects could occur during flight on certain Boeing Model 777 airplanes with certain airplane information management system

(AIMS)software. The following airplane effects could potentially occur: A false measure of cabin pressure by the left air supply and cabin pressure controller (ASCPC) could result in an unannunciated loss of cabin pressure. If an undetected loss of pressure event were to cause an unsafe pressure in the cabin, the flightcrew could become incapacitated. Relevant Service Information We have reviewed Boeing Alert Service Bulletin 777-31A0119, Revision 1, dated March 27, 2007; and Boeing Alert Service Bulletin 777-31A0120, Revision 1, dated March 23, 2007. Service Bulletin 777-31A0119 describes procedures for installing the AIMS-1 Blockpoint 2006

(BP06)operational software in the AIMS-1 hardware. Service Bulletin 777-31A0120 describes procedures for installing the AIMS-2 BP06 operational software in the AIMS-2 hardware. Concurrent Service Bulletins Boeing Alert Service Bulletin 777-31A0119 recommends prior or concurrent accomplishment of Boeing Special Attention Service Bulletin 777-31-0098, Revision 1, dated May 3, 2007. That service bulletin describes procedures for installing the AIMS-1 Blockpoint 2005A (BP05A) operational software. Boeing Alert Service Bulletin 777-31A0120 recommends prior or concurrent accomplishment of Boeing Special Attention Service Bulletin 777-31-0097, Revision 3, dated February 22, 2007. That service bulletin describes procedures for installing the AIMS-2 BP05A operational software. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other airplanes of this same type design. For this reason, we are proposing this AD, which would require accomplishing the actions specified in the service information described previously. Costs of Compliance There are about 142 airplanes of the affected design in the worldwide fleet. This proposed AD would affect about 2 airplanes of U.S. registry. The proposed actions would take between 1 and 4 work hours per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the proposed AD for U.S. operators is between $160 and $640, or between $80 and $320 per airplane. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **Boeing:** Docket No. FAA-2007-0254; Directorate Identifier 2007-NM-209-AD. Comments Due Date

(a)The FAA must receive comments on this AD action by January 14, 2008. Affected ADs

(b)None. Applicability

(c)This AD applies to Boeing Model 777-200, -200LR, -300, -300ER series airplanes, certificated in any category; as identified in Boeing Alert Service Bulletin 777-31A0119, Revision 1, dated March 27, 2007; and Boeing Alert Service Bulletin 777-31A0120, Revision 1, dated March 23, 2007. Unsafe Condition

(d)This AD results from an investigation that revealed that detrimental effects could occur on certain airplane information management system

(AIMS)software during flight. We are issuing this AD to prevent an unannunciated loss of cabin pressure. If an undetected loss of pressure event were to cause an unsafe pressure in the cabin, the flight crew could become incapacitated. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Software Installation

(f)Within 15 months after the effective date of this AD, do the actions specified in paragraphs (f)(1) and (f)(2) of this AD, as applicable.

(1)Install the AIMS Blockpoint 2006

(BP06)operational software by doing all the actions in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 777-31A0119, Revision 1, dated March 27, 2007; or Boeing Alert Service Bulletin 777-31A0120, Revision 1, dated March 23, 2007; as applicable.

(2)Prior to or concurrently with accomplishing the software installation, install the AIMS Blockpoint 2005A (BP05A) software in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 777-31-0098, Revision 1, dated May 3, 2007; or Boeing Special Attention Service Bulletin 777-31-0097, Revision 3, dated February 22, 2007; as applicable. Credit for Actions Done Using Previous Service Information

(g)Actions accomplished before the effective date of this AD in accordance with Boeing Alert Service Bulletin 777-31A0119, or Boeing Alert Service Bulletin 777-31A0120, both dated October 16, 2006, are considered acceptable for compliance with the corresponding actions specified in this AD. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector

(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Issued in Renton, Washington, on November 20, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-23117 Filed 11-27-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 347 and 352 [Docket No. 1978N-0038] (formerly 78N-0038) RIN 0910-AF43 Sunscreen Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period. SUMMARY: The Food and Drug Administration

(FDA)is extending to December 26, 2007, the comment period for the August 27, 2007, proposed rule to amend the final monograph for over-the-counter

(OTC)sunscreen drug products (72 FR 49070). The comment period for the proposed rule was to end on November 26, 2007. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit written or electronic comments by December 26, 2007. ADDRESSES: You may submit comments, identified by Docket No. 1978N-0038 and RIN number 0910-AF43, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name, docket number and regulatory information number

(RIN)for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Request for Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Matthew R. Holman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5414, Silver Spring, MD 20993, 301-796-2090. SUPPLEMENTARY INFORMATION: I. Discussion In the **Federal Register** of May 21, 1999 (64 FR 27666), FDA published the final monograph for OTC sunscreen drug products in part 352 (21 CFR part 352) with an effective date of May 21, 2001. Issues concerning active ingredients, labeling, and test methods for products intended to provide ultraviolet A

(UVA)protection were deferred for future regulatory action because more time was required to review comments from interested parties. In the **Federal Register** of June 8, 2000 (65 FR 36319), FDA reopened the administrative record of the rulemaking for OTC sunscreen drug products to allow for specific comment on high sun protection factor

(SPF)and UVA radiation testing and labeling issues. FDA also extended the effective date for the final monograph to December 31, 2002. In the **Federal Register** of December 31, 2001 (66 FR 67485), FDA stayed the December 31, 2002, effective date of the final monograph for OTC sunscreen drug products in part 352 pending further notice from FDA in a future issue of the **Federal Register** . FDA took this action because we planned to amend part 352 to address formulation, labeling, and testing requirements for both ultraviolet B

(UVB)and UVA radiation protection. The existing stay of the effective date for part 352 remains in effect at this time. In the **Federal Register** of August 27, 2007 (72 FR 49070), FDA issued a proposed rule that would amend the final monograph for OTC sunscreen drug products to address both UVB and UVA testing and labeling requirements for sunscreen and sunscreen-skin protectant combination drug products. FDA requested comments on the proposed amendments. FDA also requested comments on issues related to OTC sunscreen drug products containing alpha hydroxy acids or titanium dioxide and zinc oxide formulated in particle sizes as small as a few nanometers. The comment period on the proposed rule was scheduled to end on November 26, 2007. II. Extension of the Comment Period The agency has received requests for an extension of the comment period for the proposed rule. Each request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. FDA has considered the requests and is extending the comment period for the proposed rule for 30 days, until December 26, 2007. The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. In response to several requests to extend the comment period, we are extending the comment period for 30 days, until December 26, 2007. III. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by us through the FDMS only. When the exact date of the transition to FDMS is known, we will publish a **Federal Register** notice announcing that date. IV. References The following references are on display in the Division of Dockets Management (see ADDRESSES ) under Docket No. 1978N-0038 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Comment No. EXT10. 2. Comment No. EXT11. 3. Comment No. EXT12. 4. Comment No. EXT13. 5. Comment No. EXT14. 6. Comment No. EXT15. 7. Comment No. EXT16. 8. Comment No. EXT17. 9. Comment No. EXT18. Dated: November 21, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. 07-5853 Filed 11-26-07; 9:25 am]

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