Proposed Rules. Final rule

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BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0327; FRL-8090-1] Bifenazate; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of bifenazate in or on pea, garden; pea, edible podded; vegetable, tuberous and corm, subgroup 1C; fruit, stone, group 12, except plum; plum; cattle fat; goat fat; hog fat; horse fat; and sheep fat. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 30, 2006. Objections and requests for hearings must be received on or before October 30, 2006, 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-2006-0327. All documents in the docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: 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: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 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 provides 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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2006-0327 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 on or before October 30, 2006. 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 your copies, identified by docket ID number EPA-HQ-OPP-2006-0327, 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 Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of May 3, 2006 (71 FR 26087) (FRL-8058-6), 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 petitions (PP 3E6762 and 5E6992) by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902. The petition requested that 40 CFR 180.572 be amended by establishing tolerances for combined residues of the insecticide, bifenazate, (1 methylethyl 2-(4-methoxy[1,1′-biphenyl]-3-yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy- [1,1′-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate), in or on fruit, stone, group 12 at 2.0 parts per million (ppm); pea, garden at 0.2 ppm; pea, edible podded at 4.0 ppm; and vegetable, tuberous and corm at 0.01 ppm. PP 3E6762 proposed to amend 40 CFR 180.572 by deleting existing peach and nectarine tolerances, and establish a tolerance for fruit, stone (Group 12) at 2.0 ppm. Following review of the residue chemistry data, EPA determined that the commodity terms and tolerances levels should be revised to the following: Pea, garden, succulent at 0.20 ppm; vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; and fruit, stone, group 12, except plum at 2.5 ppm. Additionally, EPA determined subsequent revisions for existing tolerances for plum at 0.20 ppm, and fat of cattle, goat, hog, horse, and sheep at 0.10 ppm (previously established at 0.3 ppm

(plum)and 0.1 ppm (animal fat commodities). EPA is also deleting established tolerances in §180.572(a) for peach and nectarine since they will be replaced by the establishment of the tolerance for residues of bifenazate on fruit, stone, group 12, except plum. Additionally, EPA is deleting the time-limited tolerance for tomato under §180.572(b) since that tolerance has expired. The notices referenced above included a summary of the petitions prepared by Crompton Uniroyal Chemical, the registrant. There were no comments received in response to the notice of filing. 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. . . .” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined of bifenazate on pea, garden, succulent at 0.20 ppm; pea, edible podded, succulent at 4.0 ppm; vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; fruit, stone, group 12, except plum at 2.5 ppm; plum at 0.20 ppm; and fat of cattle, goat, hog, horse, and sheep at 0.10 ppm. 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 toxic effects caused by bifenazate 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 www.regulations.gov (Docket ID EPA-HQ-OPP-2006-0327-0002, pages 10-12). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which the LOAEL of concern is identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect 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. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for bifenazate used for human risk assessment can be found at www.regulations.gov (Docket ID EPA-HQ-OPP-2006-0327-0002, page 15). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.572) for the combined residues of bifenazate, in or on a variety of raw agricultural and livestock commodities. A tolerance is also established for milk. Risk assessments were conducted by EPA to assess dietary exposures from bifenazate 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 bifenazate, therefore a quantitative acute dietary exposure assessment is not performed. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The chronic analyses incorporated tolerance-level residues for all commodities excluding squash, peach, tomato, and soybean (anticipated residues based on average field-trial residues were assumed) and milk (anticipated residue was assumed). The chronic analyses incorporated average percent crop treated

(PCT)information. DEEM (ver. 7.81) default processing factors were assumed for all commodities excluding apple juice, grape juice, wine/sherry, tomato paste, and tomato puree. The processing factors for these commodities were reduced to 0.23, 0.17, 0.17, 5.0, and 5.0, respectively, based on data from processing studies. iii. *Cancer* . Bifenazate has been classified as “not likely” to be a human carcinogen. Therefore, a cancer dietary exposure assessment was not performed. iv. *Anticipated residue and PCT information* . Section 408(b)(2)(E) of the 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 chemicals 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. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins 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 the Agency can make the following findings: Condition 1, that 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; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if 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: 1% for almonds, apples, apricots, cucumbers, pecans, peppers, walnuts, and watermelons; 5% for grapes, nectarines, prunes, plums, and tomatoes; 10% for peaches and pears, and 25% for strawberries. 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 bifenazate may be applied in a particular area. 2. *Dietary exposure from drinking water.* The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for bifenazate 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 physical characteristics of bifenazate. 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* . Parent bifenazate degrades rapidly in aerobic soil conditions with a half-life of approximately 30 minutes. The first degradate formed (D3598; half-life of 7 hours) was reported in a concentration of 95% of the applied radioactivity. D3598 degrades to D1989 (reported at a maximum of 26% of the applied radioactivity), which is moderately persistent with an EFED-calculated half-life of approximately 96 days. Photodegradation and other routes of dissipation of parent bifenazate do not appear to be significant. EPA concluded that the residue of concern in drinking water is D1989. Parent and D3598 were not included as a residue of concern in drinking water due to the short half-lives of these compounds and the lack of an acute dietary endpoint (toxicity of D3598 is assumed to be equivalent to bifenazate). Since ground water or surface water monitoring data are not available, a Tier I screening concentration in ground water (SCI-GROW) and surface water first index sceening tool reservoir (FIRST) were provided for the EECs of D1989. Both models were conducted using the strawberry application scenario (2 x 0.50 lbs ai/acre; 21-day RTI; highest registered/proposed application rate). Based on the SCI-GROW and FIRST models, the estimated environmental concentrations

(EECs)of bifenazate are estimated to be 6.38 parts per billion

(ppb)for chronic surface water and < 0.001 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM ). For chronic dietary risk assessment, the annual average concentration of 6.38 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). Bifenazate is currently registered for use on the following residential non-dietary site: Ornamentals. The risk assessment was conducted using the following residential exposure assumptions: EPA anticipated only short-term dermal and inhalation exposure for residential handlers. The proposed formulation was appropriate for application via pump up sprayers, garden hose-end sprayers, or similar “homeowner” pesticide devices. A larger area per day may be treated with a hose-end sprayer than with a “pump-up” compressed-air sprayer, which in turn results in possibly greater contact with the active ingredient per day. Therefore, exposure from a hose-end sprayer was assessed rather than that of a compressed-air sprayer. With respect to post-application residential exposures, no significant post-application exposure is anticipated from landscape ornamentals, either by residents or professional applicators; therefore, no residential post-application assessment was conducted. 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 bifenazate and any other substances and bifenazate 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 bifenazate 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on 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 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The developmental studies in rats and rabbits did not demonstrate any qualitative or quantitative *in utero* extra sensitivity of fetuses to bifenazate. Similarly, increased qualitative or quantitativesusceptibility to offspring was not observed from bifenazate during prenatal or postnatal development in the reproduction study. 3. *Conclusion* . The Agency evaluated the bifenazate toxicological database in reference to the potential for enhanced sensitivity to infants and children. Acceptable developmental toxicity studies in the rat and rabbit are available, as is an acceptable 2-generation reproduction study in the rat. EPA concluded that a bifenazate developmental neurotoxicity study is not required. EPA also concluded the 10X FQPA safety factor could be reduced to 1X for bifenazate for the following reasons: i. There is no indication of quantitative or qualitative increased susceptibility of rats and rabbits to *in utero* or postnatal exposure. ii. A bifenazate developmental neurotoxicity study is not required. iii. The toxicological database, the residue chemistry database and the environmental fate database, are complete for FQPA assessment. iv. The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded. v. The residential handler assessment is based upon the residential standard operating procedures (SOPs). The residential SOPs are based upon reasonable worst-case assumptions and are not expected to underestimate risk. These assessments of exposure are not likely to underestimate the resulting estimates of risk from exposure to bifenazate. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . No acute risk is expected from exposure to bifenazate since no acute endpoints were identified for the general U.S. population (including infants and children) or the females 13-50 years old population subgroup. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to bifenazate from food and water will utilize 38% of the chronic population adjusted dose

(cPAD)for the U.S. population, 79% of the cPAD for all infants ( < 1 year old), and 94% of the cPAD for children 1-2 years old. There are no residential uses for bifenazate that result in chronic residential exposure to bifenazate. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 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). Bifenazate 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 bifenazate. 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 margin of exposures

(MOEs)of 1,600 for the U.S. population, 1,900 for females 13-49 years old, and 2,000 for adults 50 years and older. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food, water, and residential uses. Therefore, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern. 4. *Aggregate cancer risk for U.S. population* . Bifenazate has been classified as “not likely” to be a human carcinogen by any relevant route of exposure. Therefore, bifenazate is expected to pose at most a negligible 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, and to infants and children from aggregate exposure to bifenazate residues. IV. Other Considerations A. Analytical Enforcement Methodology A method (UCC-D2341) is available for enforcement of the currently established plant tolerances. The methods used in the field trial and processing studies were similar to the current enforcement method. Since the procedures are similar and adequate method validation and concurrent recoveries were attained in the field trial and processing studies, EPA concludes that the current enforcement method is appropriate for enforcement of the tolerances associated with this petition. Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits Canada, Codex, and Mexico do not have maximum residue limits

(MRLs)for residues of bifenazate in/on tuberous and corm vegetables or succulent pea; therefore, harmonization is not an issue for these crops. However, Codex MRLs are established in/on peach, nectarines, plum, and prunes (no Canadian or Mexican stone fruit MRLs) at 2.0 ppm. The Codex MRL residue definition is for bifenazate per se. The U.S. and Codex tolerances/MRLs are not compatible with regard to tolerance expression and therefore, the levels can not be harmonized. V. Conclusion Therefore, the tolerance is established for combined residues of bifenazate, (1-methylethyl 2-(4-methoxy[1,1′-biphenyl]-3-yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl]-3-yl), 1-methylethyl ester, in or on pea, garden, succulent at 0.20 ppm; pea, edible podded, succulent at 4.0 ppm; vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; fruit, stone, group 12, except plum at 2.5 ppm; plum at 0.20 ppm; and fat of cattle, goat, hog, horse, and sheep at 0.10 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 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 due to its lack of significance, 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). 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.* , or 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-). 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); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the 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: August 23, 2006. Lois Rossi, 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 180.572 is amended by: i. In paragraph (a)(1), in the table, by removing the commodities “peach” and “nectarine”; revising the tolerance levels for the commodities “cattle, fat”; “goat, fat”; “hog, fat”; “horse, fat”; and “sheep, fat” and by alphabetically adding commodities “fruit, stone, group 12, except 12”; “pea, garden, succulent”; “pea, edible podded, succulent”; and “vegetable, tuberous and corm”; and ii. In paragraph (b), in the table, by removing the commodity tomato. The amendments read as follows. § 180.572 Bifenazate; tolerances for residues. (a)(1) * * * Commodity Parts per million * * * * * Cattle, fat 0.10 * * * * * Fruit, stone, group 12, except plum 2.5 Goat, fat 0.10 * * * * * Hog, fat 0.10 * * * * * Horse, fat 0.10 * * * * * Pea, garden, succulent 0.20 Pea, edible podded, succulent 4.0 * * * * * Plum 0.20 Sheep, fat 0.10 * * * * * Vegetable, tuberous and corm, subgroup 1C 0.10 FR Doc. E6-14427 Filed 8-29-06; 8:45 am BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0292; FRL-8090-2] S-metolachlor; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of S-metolachlor in or on pumpkin, and squash, winter. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective August 30, 2006. Objections and requests for hearings must be received on or before October 30, 2006, 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-2006-0292. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(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: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 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 provides 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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2006-0292 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 on or before October 30, 2006. 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 your copies, identified by docket ID number EPA-HQ-OPP-2006-0292, 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

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of April 21, 2006 71 FR 20663 FRL-8064-6, 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 5E7015) by IR-4, 681 Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.368(a)(3) be amended by establishing tolerances for combined residues of the herbicide S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], its R-enantiomer, and its metabolites, determined as the derivatives, 2-[2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, in or on pumpkin and squash, winter at 1.0 part per million (ppm), respectively. The tolerances were subsequently amended to 0.1 ppm for raw agricultural commodities previously mentioned. This notice included a summary of the petition prepared by Syngenta, the registrant. There were no comments received in response to the notice of filing. 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....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with 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, consistent with section 408(b)(2) of FFDCA, for tolerances for combined residues of S-metolachlor on pumpkin at 0.1 ppm, and squash, winter at 0.1 ppm. EPA's assessment of exposure and risk associated with establishing the tolerances 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 toxic effects caused by metolachlor and S-metolachlor 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 www.regulations.gov (Docket No. EPA-HQ-OPP- 2006-0292-0003; pages 53-64). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect 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. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for metolachlor and S-metolachlor used for human risk assessment is discussed at www.regulations.gov (Docket No. EPA-HQ-OPP-2006-0292; pages 20-21). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.368) for the combined residues of S-metolachlor, in or on a variety of raw agricultural commodities. Meat, milk, poultry and egg tolerances have also been established. Risk assessments were conducted by EPA to assess dietary exposures from S-metolachlor in food as follows: Both the acute and chronic analyses assume tolerance-level residues on all crops with established, pending, or proposed tolerances for metolachlor and/or S-metolachlor. In cases where separate tolerance listings occur for both metolachlor and S-metolachlor on the same commodity, the higher value of the two is used in the analyses. 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 one-day or single exposure. In conducting the acute dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An acute dietary analysis for S-metolachlor was conducted using tolerance level residues and 100 % crop treated

(CT)for all existing and proposed uses. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A chronic dietary analysis for S-metolachlor was conducted using tolerance level residues and 100 %CT data for all existing and proposed uses. iii. *Cancer* . Metolachlor has been classified as a Group C, possible human carcinogen based on liver tumors in rats at the highest dose tested (HDT). The chronic NOAEL of 15 mg/kg/day that was established based on tumors in the rat (seen at the HDT of 150 mg/kg/day) is comparable to the NOAEL of 9.7 mg/kg/day selected for establishing the chronic reference dose for metolachlor. EPA has concluded that the chronic dietary PAD is protective for cancer dietary risk. Therefore, a separate cancer aggregate risk assessment was not conducted. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for s-metolachlor 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 physical characteristics of s-metolachor. 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* . A drinking water assessment was conducted based on monitoring data from several sources, as well as on Tier 1 FIRST and SCI-GROW modeling results. This assessment is a worst-case scenario and demonstrates high end numbers. The analytical methods used to obtain the monitoring data are not able to distinguish between metolachlor and S-metolachlor; therefore, the estimated environmental concentrations

(EECs)presented in this risk assessment are representative of both racemic metolachlor and S-metolachlor. EECs for metolachlor and S-metolachlor were calculated for both the parent compound and the ethanesulfonic acid

(ESA)and oxanilic acid

(OA)degradates. Although it was determined by the EPA that the ESA and OA metabolites appear to be less toxic than parent metolachlor, they are included in the risk assessment since they were found in greater abundance than the parent in water monitoring studies. The crops with the highest maximum seasonal application rates are turf (S-metolachlor only) and corn (racemic metolachlor and S-metolachlor) with a maximum seasonal application rate of 4.0 lbs ai/A. Based on PRZM/EXAMS modeling the maximum peak and annual average concentrations of metolachlor/ S-metolachlor in surface water were 199 ug/l and 9.2 ug/l, respectively. Based on FIRST modeling results, the estimate of the drinking water concentration from surface water sources of metolachlor ESA, a major degradate of metolachlor, is not likely to exceed 31.9 ug/L for the annual peak concentration and 22.8 ug/L for the annual average exposure for use on turf/corn at a maximum annual application rate of 4.0 lbs ai/A. Based on FIRST modeling results, the estimate of the drinking water concentration from surface water sources of metolachlor OA, another major degradate of metolachlor, is not likely to exceed 91.4 ug/L for the annual peak concentration and 65.1 ug/L for the annual average exposure for use on turf/corn at a maximum annual application rate of 4.0 lbs ai/A (ground application with no spray drift). The SCI-GROW screening model was used to estimate groundwater concentrations. The estimated concentration of metolachlor/ S-metolachlor in drinking water from shallow groundwater sources is 5.5 ug/l for application on corn at a seasonal maximum rate of 4.0 lbs ai/A. This concentration is appropriate for both the peak and annual average exposures. The EEC for metolachlor degradate ESA based on metolachlor use on turf/corn is not expected to exceed 65.8 ug/l for peak and annual average exposures. The EEC for metolachlor OA from metolachlor use on turf/corn is not expected to exceed 31.7 ug/l for peak and annual average exposures. Table 1: Metolachlor EEC's Surface Water

(peak)Surface Water (average) Ground Water Parent 199 9.2 5.5 metolachlor ESA 31.9 22.8 65.8 metolachlor OA 91.4 65.1 31.7 Total EECs

(ppb)322.3 97.1 103.0 Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM ). For acute dietary risk, since the surface water EDWCs are higher than the groundwater EDWC, the peak concentration of 322.3 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, since the ground water EDWCs are higher than the surface water EDWC the ground water concentration of 103.0 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). The formulated S-metolachlor end-use product is labeled under the trade name Pennant MAGNUM TM (EPA Reg. No. 100-950) to distinguish the new product from the original metolachlor formulation named Pennant TM (EPA Reg. No. 100-691). Pennant MAGNUM TM (7.62 lbs. active ingredient per gallon) is labeled for use on commercial (sod farm) and residential warm-season turfgrasses and other noncrop land including golf courses, sports fields, and ornamental gardens. Although not labeled as a restricted-use pesticide, Pennant MAGNUM TM , as currently marketed, is not intended for homeowner purchase or use (intended for use by professionals). On this basis, with regard to the requirements of FQPA, metolachlor and S-metolachlor are assessed only for post application exposure and risk. Pennant MAGNUM TM and Pennant TM are both emulsifiable concentrates (EC). For this risk assessment, small children are the population group of concern. Although the type of site that S-metolachlor may be used on varies from golf courses to ornamental gardens, the scenario chosen for risk assessment (residential turf use) represents what the Agency considers the likely upper-end of possible exposure. Post application exposures from various activities following lawn treatment are considered to be the most common and significant in residential settings. Since toxicity was not observed in a dermal toxicity study, up to a dose level of 1,000 mg/kg/day, the only parameter of risk addressed in this assessment is the possible oral exposure of small children from treated turf, or soil. The estimate for hand-to-mouth exposure on the day of treatment is 0.037 mg/kg/day (MOE = 1,400) for S-metolachlor and 0.06 mg/kg/day (MOE = 840) for metolachlor. (MOE estimates are based on the short-term NOAEL of 50 mg/kg/day). The estimate for object-to-mouth exposure on the day of treatment is 0.0092 mg/kg/day (MOE = 5,400) for S-metolachlor and 0.015 mg/kg/day (MOE = 3,300) for metolachlor. (MOE estimates are based on the short-term NOAEL of 50 mg/kg/day). The estimate for soil ingestion exposure on the day of treatment is 0.00012 mg/kg/day (MOE = 400,000) for S-metolachlor and 0.0002 mg/kg/day (MOE = 250,000) for metolachlor. (MOE estimates are based on the short-term NOAEL of 50 mg/kg/day). The estimate for hand-to-mouth, object-to-mouth, and soil ingestion combined (on the day of treatment) is 0.046 mg/kg/day (MOE = 1,100) for S-metolachlor and 0.075 mg/kg/day (MOE = 670) for metolachlor. (MOE estimates are based on the short-term NOAEL of 50 mg/kg/day). The MOE estimates are greater than 100 and indicate that the potential metolachlor/S-metolachlor exposure (to children) associated with residential use is not of concern. Although considered an upper-bound, the exposure estimate for the three scenarios, combined, is recommended for aggregate (residential, food, and drinking water) risk estimates. 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 S-metolachlor and any other substances and S-metolachlor 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 S-metolachlor 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on 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 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* —i. *Metolachlor* . The prenatal developmental studies in the rat and rabbit revealed no evidence of a qualitative or quantitative susceptibility in fetal animals. In the rabbit prenatal developmental toxicity study, at 360 mg/kg/day, maternal animals had persistent anorexia and decreased body weight gain; the NOAEL was 120 mg/kg/day. In the rat prenatal developmental toxicity study, frank toxicity [death, clinical signs (clonic and/or tonic convulsions, excessive salivation, urine-stained abdominal fur and/or excessive salivation) and decreased body weight gain] was observed at the limit dose of 1,000 mg/kg/day in maternal animals; the NOAEL was 300 mg/kg/day. The developmental effects at 1,000 mg/kg/day included slightly decreased number of implantations per dam, decreased number of live fetuses/dam, increased number of resorptions/dam and significant decrease in mean fetal body weight. In the two-generation reproduction study in rats, there was no evidence of parental or reproductive toxicity at approximately 80 mg/kg/day, the HDT. At this dose, there was a minor decrease in fetal body weight beginning at lactation day 4; the NOAEL was approximately 25 mg/kg/day. Since a similar body weight decrease was not seen on lactation day zero, the cause of the effect on later lactation days is most likely due to exposure of the pups to metolachlor in the diet and/or milk and therefore is not evidence of an increased quantitative susceptibility in post-natal animals. ii. *S-metolachlor* . There was no evidence of increased quantitative or qualitative fetal susceptibility in the prenatal developmental studies in rats and rabbits. In the rat, maternal toxicity [increased clinical signs of toxicity (pushing head through bedding) and decreased body weights/body weight gains, food consumption and food efficiency was observed at 500 mg/kg/day; the NOAEL was 50 mg/kg/day. There were no developmental effects at 1,000 mg/kg/day, the HDT. In the rabbit, clinical signs of toxicity (little/none/soft stool) were observed at 100 mg/kg/day; the NOAEL was 20 mg/kg/day. No developmental effects were observed at 500 mg/kg/day, the HDT. 3. *Conclusion* . There is a complete toxicity data base for S-metolachlor and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be reduced to 1X for the following reasons: i. The toxicology database is complete for the FQPA assessment. ii. There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to *in utero* and/or postnatal exposure to metolachlor or S-metolachlor in the available toxicity data. iii. A developmental neurotoxicity study is not required for metolachlor or S-metolachlor. iv. The dietary (food and drinking water) and non-dietary exposure (residential) assessments will not underestimate the potential exposures for infants and children from the use of metolachlor or S-metolachlor. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to S-metolachlor will occupy <1% of the aPAD for the US population and other population subgroups, and 2% of the aPAD for all infants <1 year old. EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to S-metolachlor from food and water will utilize 4% of the cPAD for the U.S. population, 10% of the cPAD for all infants < 1 year old, and 8% of the cPAD for children 1-2 years old. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 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). A short-term aggregate risk assessment considers potential exposure from food, drinking water, and short-term, non-occupational (residential) pathways of exposure for a duration of 1 to 30 days. Potential short-term, non-occupational risk scenarios for S-metolachlor consist of oral exposure of children to treated lawns only. In this aggregate short-term risk assessment, exposure from food, drinking water, and residential lawns has been considered. The exposure to food and water has already been considered in the chronic dietary risk assessment. Since only children have the potential for non-occupational, short-term risk, they are the only population subgroup for which an aggregate short-term risk assessment was conducted. Toddlers' S-metolachlor incidental oral exposure is assumed to include hand-to-mouth exposure, object-to-mouth exposure and exposure through incidental ingestion of soil. Table 2.—Aggregate Risk Assessment for Short-Term Exposure to S-metolachlor Population Short-Term Scenario NOAEL mg/kg/day LOC 1 Average Food and Water Exposure mg/kg/day Residential Exposure mg/kg/day 2 Aggregate MOE (food, water and residential) 3 All infants <1 yr old 50 100 0.010003 0.046 890 1 The level of concern

(LOC)MOE is 100, based on inter- and intra-species safety factors totaling 100. 2 Residential Exposure = [Incidental Oral exposure from all possible sources-combined hand-to-mouth, object-to-mouth, and soil ingestion oral exposure]. No residential oral exposure is expected for adults 3 Aggregate MOE = [NOAEL ÷ (Avg Food and Water Exposure + Residential Exposure)] 4. *Aggregate cancer risk for U.S. population* . S-metolachlor is classified as classified as a Group C, possible human carcinogen. EPA has concluded that the chronic dietary PAD is protective for cancer dietary risk and, as noted above, chronic exposure is below the chronic dietary PAD. 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, and to infants and children from aggregate exposure to S-metolachlor residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate methodology is available for enforcing the current and proposed tolerances. The Pesticide Analytical Manual (PAM, Vol. II) lists a GC/NPD method (Methods I) for determining residues in/on plants and a GC/MSD method (Method II) for determining residues in livestock commodities. These methods determine residues of S-metolachlor and its metabolites as either CGA-37913 or CGA-49751 following acid hydrolysis. A modified version of this method (Syngenta Method No. 1848-01) which uses liquid chromotography/mass spectrometry/mass spectrometry (LC/MS/MS) has also been used. Adequate data are available on the recovery of metolachlor through Multi-residue Method Testing Protocols. The FDA PESTDATA database indicates that S-metolachlor is completely recovered through Method 302, PAM Vol. I. B. International Residue Limits There are currently no Codex, Canadian or Mexican MRLs for S-metolachlor; therefore there are no international harmonization issues for these actions. V. Conclusion Therefore, the tolerances are established for combined residues of S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], its R-enantiomer, and its metabolites, determined as the derivatives, 2-[2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, in or on pumpkin and squash, winter at 0.1 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

(UMRA)(Public Law 104-4). 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); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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). 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

(3)* * * Commodity Parts per million * * * * * Pumpkin 0.1 * * * * * Squash, winter 0.1 * * * * * [FR Doc. E6-14443 Filed 8-29-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0537; FRL-8086-2] Ethofumesate; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of the herbicide, ethofumesate in or on carrot, roots (with regional restrictions for use in the States of Washington and Oregon), beet, garden, tops and beet, garden, roots; onion, bulb; garlic, bulb; shallot, bulb; and shallot, fresh leaves. The Interregional Research Project #4 (IR-4), 681 Highway 1 South, North Brunswick, NJ 08902-3390 requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective August 30, 2006. Objections and requests for hearings must be received on or before October 30, 2006, 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-2005-0537. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-7610; e-mail address: *jackson.sidney@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 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 provides 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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2005-0537 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 on or before October 30, 2006. 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 your copies, identified by docket ID number EPA-HQ-OPP-2005-0537, 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

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of March 22, 2006 (71 FR 14522) (FRL-7767-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of (pesticide petitions

(PP)3E6564, 3E6565 and 5E6914) by IR-4, 681 Highway 1 South, North Brunswick, NJ 08902-3390 on behalf of the registrant, Bayer CropScience. The petition requested that 40 CFR 180.345 be amended by establishing tolerances for combined residues of the herbicide ethofumesate (2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5-benzofuranyl methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (both calculated as the parent compound) in or on the raw agricultural commodities: Carrots (with regional restrictions for use in the States of Washington and Oregon) at 10 parts per million

(ppm)(PP 3E6565), garden beets tops at 4 ppm, garden beet roots at 0.5 ppm (PP 3E6564), onion, dry bulb at 0.30 ppm (PP 5E6914), garlic, bulb at 0.30 ppm (PP 5E6914), and shallot at 0.30 ppm (PP 5E6914). That notice included a summary of the petitions prepared by Bayer CropScience, P. O. Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709, the registrant. There were no comments received in response to the notice of filing. Supporting documents including the Reregistration Eligibility Decision

(RED)for Ethofumesate, EPA 738-R-05-010, Sept. 2005, can be viewed on-line along with the Agency's Human Health Risk Assessment of ethofumesate and other supporting documents at *www.regulations.gov* under the index of the docket for this action, Docket ID number: EPA-HQ-OPP-2005-0537. The Agency's reregistration and tolerance reassessment of ethofumesate are completed. Due to its uses, risks, and other factors, ethofumesate was reviewed/reassessed through the modified 4-Phase process as outlined in the **Federal Register** on May 14, 2004 (69 FR 26819)(FRL-7357-9). Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for ethofumesate. 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....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with 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, consistent with section 408(b)(2) of FFDCA, for tolerances for combined residues of ethofumesate on: Carrot (with regional restrictions for use in Washington and Oregon) at 7.0 ppm, beet, garden, tops at 4.0 ppm, beet, garden, roots at 0.5 ppm, onion, dry bulb at 0.25 ppm, garlic, bulb at 0.25 ppm, and shallot at 0.25 ppm. It can be noted that the tolerance level for certain commodities was revised, based on current data evaluations and differ from the proposed level presented in the Notice of Filing on March 22, 2006 or as recommended in the RED for ethofumesate. These revisions include: Carrot tolerance at 7.0 ppm, reduced from 10.0 ppm; and garlic, bulb; onion, dry bulb and shallot tolerances set at 0.25 ppm, reduced from 0.30 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 their 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 toxic effects caused by ethofumesate 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 *www.regulations.gov* . B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect 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. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm.* A summary of the toxicological endpoints for ethofumesate used for human risk assessment can be found in the index of this document, Docket ID number EPA-HQ-OPP-2005-0537, entitled, “Human Health Risk Assessment for Proposed Uses on Onion, Bulb”, (Table 3.4.15) (dated April 24, 2006). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.345 for the combined residues of ethofumesate, in or on a variety of raw agricultural commodities; plant commodities range from 0.1 ppm in/on sugar beet roots to 1.0 ppm in/on sugar beet tops and grass straw. Tolerances on animal commodities including fat, meat and meat byproducts are set at 0.05 ppm. A process feeds tolerance in sugar beet molasses is set at 0.5 ppm. Risk assessments were conducted by EPA to assess dietary exposures from ethofumesate 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 appropriate endpoint was identified for the general population and infants since no such effects were identified in the toxicological studies for ethofumesate; therefore, a quantitative acute dietary exposure assessment was not conducted for these populations. For females, 13 plus years of age, in conducting the acute dietary (food + water) exposure assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID( TM ) Version 2.03), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: A conservative acute dietary assessment was performed using tolerance level residues and 100 % crop treated

(PCT)in the assessment. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID TM . The following assumptions were made for the chronic exposure assessments: A conservative chronic dietary (food + water) assessment was performed using tolerance level residues and 100 PCT. iii. *Cancer* . Ethofumesate is classified as “not likely to be a human carcinogen,” based on bioassays in the rat and the mouse. An exposure assessment for the purpose of assessing cancer risk is not needed. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for ethofumesate 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 physical characteristics of ethofumesate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found *http://www.epa.gov/oppefed1/models/water/index* . Typically EPA evaluates the potential for human exposure to pesticides in drinking water through an assessment of available surface water and ground water monitoring data and modeling. For ethofumesate, no monitoring data were available for use in this drinking water assessment. Therefore, potential human exposures to ethofumesate were evaluated through modeling. Estimated exposure concentrations

(EECs)in surface water were calculated using Pesticide Root Zone Model/Exposure Analyses Modeling System (PRZM/EXAMS). Ground water concentrations were modeled using screening concentration in ground water (SCI-GROW) (version 2.3). Drinking water residues were then incorporated into the DEEM-FCID( TM ) into the food categories “water, direct, all sources” and “water, indirect, all sources.” The Agency concluded that degradates of ethofumesate are of toxicological equivalence to the parent. Because these degradates were detected in environmental fate studies in relatively low amounts (10%), only the parent needs to be assessed for drinking water. Based on the PRZM/EXAMS - Index Reservoir and SCI-GROW models, the estimated environmental concentrations

(EECs)of ethofumesate for acute exposures are estimated to be 154 parts per billion

(ppb)for surface water and 8.4 ppb for ground water. The EECs for chronic exposures are estimated to be 45.5 ppb for for surface water and 8.4 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM ). For the acute assessment, the peak concentration of 154 ppb was used to access the contribution to drinking water; for the chronic assessment, the annual mean value of 45.5 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). Ethofumesate is currently registered for use on the following residential non-dietary sites: Turf grasses/lawns. The risk assessment was conducted using the following residential exposure assumptions: All ethofumesate products are intended for either agricultural use or require professional application for ornamental turf. For potential ethofumesate residential post-application exposure, the Agency conducted screening level calculations on the scenarios most likely to result in highest possible exposure to this herbicide. The other aspects of the turf exposure scenario involve calculating dose from non-dietary ingestion that arises from the hand-to-mouth, object-to-mouth and soil ingestion pathways. These processes are: For toddlers: Incidental ingestion (hand-to-mouth); Incidental ingestion (turf-to-mouth); Incidental ingestion (soil-to-mouth); Incidental dermal; For adults: Jazzercise (on treated turf). EPA believes that this screening level assessment will be protective of other possible residential exposures to ethofumesate such as golfing, and mowing the lawn. Exposures were calculated by considering the potential sources of exposure then calculating dermal exposure, and risks. The Agency calculated Margin of Exposure (MOE)s for each exposure pathway and for all pathway combinations. 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 ethofumesate and any other substances and ethofumesate 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 ethofumesate 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on 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 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The Agency determined based on the weight-of-the-evidence considerations that there are no concerns or uncertainties for prenatal and/or postnatal toxicity resulting from exposure to ethofumesate. There is evidence for increased quantitative susceptibility following *in utero* exposure to rabbits. At 300 milligrams/kilograms/day (mg/kg/day), no maternal toxicity was reported but developmental toxicity was observed as increased resorptions, post-implantation loss and skeletal abnormalities (incomplete ossification of vertebral arches). No evidence of increased susceptibility was observed in the rat in either the developmental or reproductive toxicity study. In the rat developmental toxicity study, no developmental effects were reported at the highest dose tested (limit dose of 1,000 mg/kg/day). In the 3-generation rat reproductive toxicity study, maternal, reproductive and offspring toxicity were not observed at any dose tested up to 5,000 ppm (396.8 and 462.5 mg/kg/day, males and females, respectively). The Agency concluded that although increased prenatal quantitative susceptibility was observed in the rabbit developmental toxicity study, there is no concern that the risk assessment will not adequately safeguard against potential prenatal and postnatal toxicity because the developmental toxicity NOAELs/LOAELs are well characterized and are used as endpoints for risk assessment for the appropriate population subgroups. 3. *Conclusion* . The toxicity database for ethofumesate is adequate in terms of endpoint studies and dose response information to characterize any potential prenatal or postnatal risk for infants and children. However, a 28-day inhalation toxicity study has been required to assess inhalation exposure, due to the potential for inhalation exposure during application. In the absence of this study, the inhalation exposure used a 100% default assumption. Additionally, a dermal absorption (or penetration) study to determine the dermal absorption potential has been required since data on dermal penetration of ethofumesate are unavailable at this time. A default assumption of 100% dermal absorption was selected due to the unavailability of comparative oral and dermal toxicity data with a common endpoint in the same species. There are several uncertainties present in this risk assessment: i. While ethofumesate toxicological databases are substantially complete, confidence in several areas of the risk assessment would improve with more data. In addition to the requirement for the 28-day inhalation study, data are needed for residue chemistry (i.e, a new cattle feeding study and recovery data for metabolites) as well as for metabolism (i.e. extensive field rotational crop studies). ii. The extrapolation from oral studies for both the dermal and inhalation portions of the risk assessment in conjunction with a dose spacing concern for the developmental study used to develop residential or occupational assessments for women 13+ years render a highly conservative analysis. iii. There are uncertainties associated with the drinking water assessment but the limitations related to modeling drinking water exposure did not contribute to an overall concern because the highest aggregate food and water values did not exceed Agency's LOC. Based on the available data, EPA is confident that the values used in this risk assessment are protective. No increase in susceptibility of rats was seen in developmental studies or in a rat 3-generation reproductive study. Although increased prenatal quantitative sensitivity was observed in the rabbit developmental toxicity study, the developmental toxicity NOAELs and LOAELs are well characterized and are used as endpoints for risk assessment for the appropriate population subgroups. The Agency evaluated the potential for increased susceptibility of infants and children from exposure to ethofumesate as required by the FQPA of 1996. All doses for risk assessment purposes were assessed using UFs of 10X for interspecies extrapolation and 10X for intraspecies variability. Acceptable developmental and reproduction studies have been submitted and reviewed. The Agency evaluated the quality of the exposure data to determine if the the special FQPA

(10X)Safety Factor can be reduced based on the following considerations: Dietary food exposure assessment utilizes proposed tolerance level or higher residues and 100 PCT information for all commodities. By using these screening-level assessments, chronic exposures/risks will not be underestimated. Dietary drinking water assessment (Tier 1 estimates) utilizes values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. Residential exposure assessment utilizes: Activity specific transfer coefficients and chemical-specific turf transferable residue

(TTR)studies for the post-application scenario. The refined residential assessment is based on reliable data and is unlikely to underestimate exposure/risk. The Agency concluded that there is no concern for prenatal and/or postnatal toxicity resulting from exposure to ethofumesate. Therefore, no special FQPA Safety Factor (i.e. 10X) is needed since there are no residual uncertainties for prenatal and/or postnatal toxicity. Hence, a Safety Factor

(1X)was applied. E. Aggregate Risks and Determination of Safety In examining aggregate risk, the Agency takes into account all available reliable information concerning exposures from pesticide residues in food and other exposures including drinking water and potential residential exposure to pesticides from such uses as lawn care applications (turf), golf course and others. Aggregate risk assessment considerations must also include potential exposures from oral, dermal and inhalation routes. 1. *Acute risk* . For the acute aggregate risk scenario, food and drinking water exposures were taken into account in the dietary exposure assessment. The estimated dietary exposures (food and water) for females 13-49 years, the only population subgroup of toxicological concern identified at this time, at 4% of the acute Population Adjusted Dose (aPAD). The contribution of food and food forms to this estimate, at the 95th percentile, is 2.1%. A risk estimate that is less than 100% of the aPAD, the dose at which an individual could be exposed on any given day with no adverse health effects, does not exceed the Agency's LOC. 2. *Chronic risk* . For the chronic aggregate risk scenario, food, drinking water, and residential exposures were taken into account. Chronic exposure in residential settings is not expected and the aggregate chronic assessment included food and drinking water only. Since the dietary exposure assessment already includes the highest chronic exposure from the drinking water modeling data, i.e., an estimated maximum 1 in 10 year average concentration of 45.5 ppb no further calculations are necessary. The dietary exposure estimate for all population subgroups was <1% of the chronic Population Adjusted Dose

(cPAD)with the most highly exposed subgroup being all infants <1 yrs old. Risk estimates for all population subgroups are below the Agency's LOC (100% of the cPAD). 3. *Short- and intermediate-term aggregate risk* . Short- and Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Ethofumesate 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 ethofumesate. For short- and intermediate-term assessments, the oral, dermal and inhalation pathways can be combined due to the common toxicity endpoint via the oral, dermal (oral equivalent) and inhalation (oral equivalent) routes for the appropriate population of concern. For the short-and intermediate-term aggregate risk scenarios, food, drinking water and residential exposures are taken into account. The aggregate short- and intermediate-term MOEs, combining food, drinking water and residential exposures ranged from 160 for all infants <1 yrs old to 270 for the U.S. population. With the exception of women of child-bearing years, residential post-application MOEs for toddlers and adults to ethofumesate on treated turf, regardless of the pathway of exposure, do not exceed the EPA's LOC. In the case of women of child-bearing years, MOEs are 73 for 1.5 pounds active ingedient/Acre (lb ai/A) application rate for turf and 27 for the 3.0 lb ai/A application rate for turf. The rate of 1.5 lb ai/A covers the majority of uses; however, the label does permit a 3.0 lb ai/A rate specifically for suppression of Bermuda grass in St Augustine grass turf. While the residential postapplication scenarios for females resulted in apparent risks of concern, the Agency believes that these scenarios are very conservative and unlikely to occur. The developmental endpoint used to estimate risk for females was based on a study with a NOAEL (30 mg/kg/day) that is 10X lower than the LOAEL (300 mg/kg/day); therefore the NOAEL may be an artifact of dose selection. Additionally, for the residential exposures, the endpoint is oral while the assessed exposures are dermal and conservative standard operating procedure (SOP)-based default assumptions such as 100% dermal absorption, default turf transferable residue dissipation assumptions, contact with turf immediately post-treatment and maximum application rates were used in this assessment. Further, it should be noted that estimated exposures are extremely conservative due not only to assumption of 100% dermal absorption but also because they assume exposure at levels immediately after application, maximal levels of dermal exposure activity, maximum dermal contact, and maximum dermal surface contact areas. Additionally, ethofumesate has minimal lawncare and commercial turf uses, which is the scenario where high dermal exposure activities would occur. The predominant use is on golf courses and sod farms. High exposure activities would likely not occur on a golf course. Ethofumesate residues resulting from sod farm application would likely dissipate significantly before sod was transplanted to residential or commercial turf. However, to address this concern, the Agency is requiring a dermal absorption study to permit more realistic estimation of dermal absorption. Nonetheless, Agency scientist's consider this a highly conservative estimate of post-application risk for the population females 13-49 years of age exposed to ethofumesate on turf and based on the available data, the EPA is confident that the values used in this risk assessment are protective. 4. *Aggregate cancer risk for U.S. population* . Ethofumesate is classified as “not likely to be a carcinogen to humans” based on the lack of carcinogenicity in the mouse carcinogenicity study and lack of convincing evidence for carcinogenicity in the rat chronic toxicity/carcinogenicity study. In addition, no evidence of genotoxicity of ethofumesate was observed in available genotoxicity studies. Therefore, ethofumesate is not expected to pose a cancer risk and a cancer aggregate risk assessment was not performed. 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, and to infants and children from aggregate exposure to ethofumesate residues. IV. Other Considerations A. Analytical Enforcement Methodology A tolerance enforcement method is listed as Method I in PAM Vol. II (Section 108.345) for determining the currently regulated residues in plants, which include ethofumesate and its metabolites (free and conjugated). Residues are determined using gas chromatography with flame ionization detector (GC/FID) in the sulfur mode with an internal standard. The reported limit of quantification(LOQ) for each analyte is 0.02 ppm. Aequate enforcement methodology (gas chromatography with flame ionization detector (GC/FID)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

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

(MRLs)established for ethofumesate, therefore there are no international harmonization issues for this action. V. Conclusion Therefore, the tolerance is established for combined residues of ethofumesate, (2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5-benzofuranyl methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (both calculated as the parent compound) in or on the raw agricultural commodities: Carrot, roots (with regional restrictions for us in the States of Washington and Oregon) at 7.0 ppm; beet, garden, tops at 4 ppm; beet, garden, roots at 0.5 ppm; onion, bulb at 0.25 ppm; garlic, bulb at 0.25 ppm; shallot, bulb and shallot, fresh leaves at 0.25 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

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. The Agency hereby certifies that this rule will not have significant negative economic impact on a substantial number of small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the 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: August 23, 2006. Lois Rossi, 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 180.345 is amended as follows: i. In paragraph

(a)by designating the introductory text and table as paragraph (a)(1) and by alphabetically adding commodities to the table; and ii. Paragraph

(c)is amended by adding text and a table. The amendments read as follows: § 180.345 Ethofumesate; tolerances for residues.

(a)*General* .

(1)* * * Commodity Parts per million Beet, garden, roots 0.5 Beet, garden, tops 4.0 * * * * * Garlic, bulb 0.25 * * * * * Onion, bulb 0.25 Shallot, bulb 0.25 Shallot, fresh leaves 0.25 * * * * *

(c)*Tolerances with regional registration.* Tolerances with regional registration as defined in 40 CFR 180.1(m) are established for the combined residues of ethofumesate,(2-ethoxy -2, 3-dihydro-3, 3-dimethyl-5-benzofuranyl methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (both calculated as the parent compound) in or on the raw agricultural commodities: Commodity Parts per million Carrot, roots 7.0 [FR Doc. E6-14431 Filed 8-29-06; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 06-1585; MB Docket No. 05-32; RM-10988] Radio Broadcasting Services; Homerville, GA and Jacksonville, FL AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: At the request of Association for the Studies of American Heritage Corporation, the Audio Division allots Channel 246A at Homerville, Georgia, as that community's second local aural transmission service. To accommodate the Homerville allotment, Station WKQL(FM), Jacksonville, Florida, Channel 245C, is reclassified to specify operation on Channel 245C0. Channel 246A is allotted at Homerville with a site restriction of 11.1 kilometers (6.9 miles) northwest of the community at coordinates 31-07-16 NL and 82-48-51 WL. Station WKQL(FM) is reclassified to specify operation on Channel 245C0 rather than Channel 245C, at Jacksonville, Florida at its license coordinates 30-16-34 NL and 81-33-53 WL. 11.7 kilometers. A filing window period for Channel 246A at Homerville will not be opened at this time. Instead, the issue of opening this allotment for auction will be addressed by the Commission in a subsequent Order. DATES: Effective September 25, 2006. ADDRESSES: Secretary, Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Victoria M. McCauley, Media Bureau,

(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Report and Order* , MB Docket No. 05-32, adopted August 9, 2006, and released August 11, 2006. At the request of Association for the Studies of American Heritage Corporation, the Audio Division allots Channel 246A at Homerville, Georgia, as that community's first local aural transmission service. 70 FR 8333 (February 18, 2005). The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC's Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *www.BCPIWEB.com* . The Commission will send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Florida is amended by removing Channel 245C at Jacksonville and adding Channel 245C0 at Jacksonville. 3. Section 73.202(b), the Table of FM Allotments under Georgia is amended by adding Channel 246A at Homerville. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division Media Bureau. [FR Doc. E6-14156 Filed 8-29-06; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF TRANSPORTATION Federal Railroad Administration 49 CFR Part 211 [Docket No. FRA-2006-24838] RIN 2130-AB79 Establishment of Emergency Relief Dockets and Procedures for Handling Petitions for Emergency Waiver of Safety Regulations AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Interim final rule; request for comments. SUMMARY: FRA is issuing procedures governing the creation of Emergency Relief Dockets

(ERD)as well as procedures for obtaining waivers from a safety rule, regulation, or standard during an emergency situation or event. FRA's purpose for establishing the ERD and emergency waiver procedures is to provide an expedited process for FRA to address the needs of the public and the railroad industry during emergency situations or events. DATES: This interim final rule is effective August 30, 2006; written comments must be received on or before October 30, 2006. Comments received after that date will be considered to the extent possible without incurring additional expense or delay. ADDRESSES: *Comments:* Any comments related to Docket No. FRA-2006-24838, may be submitted by any of the following methods: • Web Site: *http://dms.dot.gov.* Follow the instructions for submitting comments on the DOT electronic docket site. • Fax: 1-202-493-2251. • Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590-001. • Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC between 9 a.m. and 5 p.m. Monday through Friday, except Federal Holidays. • Federal eRulemaking Portal: Go to *http://www.regulations.gov* . Follow the online instructions for submitting comments. *Instructions:* All submissions must include the agency name and docket number or Regulatory Identification Number

(RIN)for this rulemaking. Note that all comments received will be posted without change to *http://dms.dot.gov* including any personal information. Please see the General Information heading in the SUPPLEMENTARY INFORMATION section of this document for Privacy Act information related to any submitted comments or materials. *Public Hearing:* Due to the limited scope of this interim final rule, FRA is not scheduling a public hearing at this time. However, FRA will consider any request for an opportunity to make an oral presentation that is filed as noted above by the deadline for written comments. *Docket:* For access to the docket to read background documents or comments received, go to *http://dms.dot.gov* at any time or to PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC between 9 a.m. and 5 p.m. Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Grady C. Cothen, Jr., Deputy Associate Administrator for Safety Standards and Program Development, FRA, 1120 Vermont Avenue, NW., RRS-2, Mail Stop 25, Washington, DC 20590 (Telephone 202-493-6302), or Michael Masci, Trial Attorney, Office of Chief Counsel, FRA, 1120 Vermont Avenue, NW., Mail Stop 10, Washington, DC 20590 (Telephone 202-493-6037). SUPPLEMENTARY INFORMATION: Background FRA is establishing emergency waiver procedures so that the agency can quickly address waiver requests in emergency situations while continuing to provide an opportunity for public input in the process. Based on lessons learned from last year's Hurricane Katrina, FRA is establishing procedures that allow the agency to expeditiously handle waiver requests that are directly related to an emergency situation or event. This will permit FRA to provide railroads necessary operational relief in a more timely manner during emergencies while at the same time maintaining public safety. Due to the catastrophic and devastating damage inflicted on the southern portion of the United States in the aftermath of Hurricane Katrina, FRA published a notice in the **Federal Register** establishing a temporary means for handling petitions for waiver from the Federal rail safety regulations that were directly related to the effects of the hurricane or were necessary to effectively address the relief efforts being undertaken in the area. *See* 70 FR 53413 (September 8, 2005). FRA recognized that these types of petitions had to be afforded special consideration and had to be handled expeditiously in order to ensure that the emergency operational needs of the railroads were addressed while at the same time ensuring the safety of the public, including railroad employees. Such emergency waivers would help ensure that routine safety regulations would not stand in the way of railroad efforts to cope with the emergency and to provide timely relief and recovery efforts. FRA's existing procedures related to the handling of petitions for waiver from the Federal rail safety regulations contained in 49 CFR part 211, do not lend themselves to quick and immediate decisions by the agency, nor were they intended to. The existing procedures establish a process whereby FRA publishes a notice of any petition for waiver in the **Federal Register** . This notice then allows interested parties a period of time in which to comment on any such petition, generally thirty

(30)days, and provides for a public hearing should one be requested. This process generally takes several months to accomplish. Accordingly, FRA instituted a temporary set of expedited procedures for handling petitions for waivers that were directly related to the effects and aftermath of Hurricane Katrina. To prepare for future emergencies, FRA is issuing procedures for handling petitions for waivers in emergency situations. These procedures are based on the temporary procedures that were instituted in response to Hurricane Katrina. FRA believes that the emergency procedures contained in this interim final rule provide the agency with the ability to promptly and effectively address waiver requests directly related to an emergency while ensuring that the public and all interested parties are afforded proper notice of any such request, and are provided a sufficient opportunity to comment on any such request. When faced with a sudden emergency event or situation the Administrator may activate the emergency waiver procedures contained in this interim final rule. FRA will consider local, state and Federal declarations of emergency when determining whether circumstances qualify as an emergency event. To declare that the emergency waiver procedures are in effect, the Administrator will issue a statement in the Document Management System

(DMS)at *http://dms.dot.gov* . The DMS will automatically notify parties that have signed up for the Emergency Waiver Listserv. (Instructions on how to sign up for automatic notification of additions to a docket are found at *http://dms.dot.gov* .) In addition, FRA will make every effort to post the statement on its Web site *http://www.fra.dot.gov/.* FRA will also publish a notice in the **Federal Register** alerting interested parties that the emergency waiver procedures will be utilized. FRA anticipates that the circumstances that constitute the occurrence of, or imminent threat of an emergency event will occur infrequently. The types of emergency events intended to be covered by this interim final rule could be local, regional, national or international in scope and could include natural and manmade disasters, such as hurricanes, floods, earthquakes, mudslides, forest fires, snowstorms, terrorist acts, increased threat levels, chemical or biological attacks, pandemic outbreaks, releases of dangerous radiological, chemical, or biological material, or war-related activities. Not only will our Nation's railroads be directly affected by many emergency events, they will also play a key role in the aftermath of those events, by providing necessary supplies and by moving displaced families and relief personnel to and from an affected area. Although the type of relief that might be granted under these provisions would vary greatly based on the type of emergency event involved, it is expected that the relief would generally involve such things as: Temporary postponement of required maintenance, repair, or inspection related to railroad equipment, track, and signals; temporary relief from certain record keeping or reporting requirements; or short-term relief from various operational requirements. Relief granted will not extend for more than nine months. For matters that may significantly impact the missions of the Department of Homeland Security (DHS), FRA will consult and coordinate with DHS as soon as practicable. FRA will establish a new ERD each calendar year. FRA will publish a notice in the **Federal Register** identifying the new docket number by January 31st of each year. When the Administrator determines the occurrence of, or imminent threat of, an emergency event, FRA will accept emergency waiver petitions for review. If FRA determines that a petition is directly related to an emergency situation, the petition will be placed in the ERD for that year. FRA will receive comments on a petition for 72 hours from the time the petition is posted on the ERD. During that time, FRA will arrange a telephone conference for any party that requests a public hearing. If, after the telephone conference, a public hearing is still desired, then FRA will arrange for such a hearing pursuant to 49 CFR part 211 as soon as practicable. These procedures are intended to balance the need for expedited waiver procedures during an emergency event to ensure public safety, and the need for adequate time to allow full public participation. The ERD and emergency waiver procedures contained in this interim final rule do not waive any regulatory requirements. They only reduce the length of the notice and comment period to permit FRA to act on the request as quickly as possible. Section-by-Section Analysis Processing of Emergency Waivers § 211.45 *§ 211.45(a).* This paragraph makes clear that the emergency waiver procedures are intended to go into effect when there is an occurrence of, or imminent threat of, an emergency event and public safety would benefit from providing the railroad industry with operational relief. The types of emergency events intended to be covered by this interim final rule could be local, regional, national or international in scope and could include natural and manmade disasters, such as hurricanes, floods, earthquakes, mudslides, forest fires, snowstorms, terrorist acts, increased threat levels, chemical or biological attacks, pandemic releases of dangerous radiological, chemical, or biological material, or war-related activities. *§ 211.45(b).* This paragraph contains information regarding FRA's creation of ERDs. Establishing a new ERD each year allows FRA to receive petitions for emergency waivers as soon as the occurrence of, or imminent threat of an emergency event is determined to have occurred. A yearly ERD is also a convenient way to organize the emergency waiver petitions and related documents. For reference purposes any petition can be located by the year in which the emergency event or situation occurred. The docket system will also provide notice to interested parties. The DMS internet site that is identified in this interim final rule allows any interested party to subscribe, without fee, to its list serve application which will automatically notify the party via e-mail when documents are added to the designated ERD. This paragraph also makes clear that FRA will publish by January 31st of each year, a **Federal Register** notice identifying the ERD for that year. This will inform interested parties where to find petitions for emergency waiver during an emergency and will allow such parties to subscribe to the DMS list serve application. Publishing a notice in the previous year's ERD will allow the parties interested in the prior year to automatically receive the new docket number. *§ 211.45(c).* This paragraph identifies the Administrator as the individual responsible for determining when the emergency waiver procedures will be utilized. The Administrator is the appropriate person to determine whether a situation or set of circumstances constitutes an emergency for purposes of FRA's use of the emergency waiver procedures. The Administrator has a unique familiarity with the rail-industry through oversight of the following: Managing comprehensive safety programs and regulatory initiatives; enforcement of FRA safety regulations; development and implementation of national freight and passenger rail policy; and oversight of diverse research and development activities in support of improved railroad safety. During significant emergencies the Administrator has extensive interaction with the Department of Homeland Security, Director of National Intelligence, the Federal Bureau of Investigation, the Surface Transportation Board and other Federal agencies responsible for addressing public safety, health, security and welfare. In addition, the Administrator maintains contemporaneous communication with relevant rail transportation entities, including passenger and freight railroads. This experience and interaction provides a basis from which the Administrator can assess whether a situation or set of circumstances rises to the level of an emergency event that would necessitate activation of the emergency waiver procedures. FRA's statement declaring that emergency procedures are in effect will be issued in the appropriate ERD. The DMS internet site that is identified in the rule text allows any interested party to subscribe, without fee, to its list serve application which automatically notifies the party via e-mail when documents are added to the appropriate ERD. The Administrator's determination that emergency waiver procedures are in effect, would be one of those documents automatically transmitted to interested parties via e-mail. In determining whether an emergency exists the Administrator may consider states of emergency issued by a local, state, or Federal official, and determinations by the Federal government that a credible threat of a terrorist attack exists. A determination made by one of these officials that a state of emergency exists, indicates that special attention is needed to address the situation, and railroad operations may be implicated. The Administrator will consider whether such emergencies significantly affect railroad operations, and whether it would be beneficial to activate the emergency waiver procedures. *§ 211.45(d).* This paragraph identifies other methods by which interested parties may be notified of FRA's determination to utilize the emergency waiver procedures. If conditions permit, FRA will issue the Administrator's determination on FRA's Web site to quickly notify the public. FRA will also publish a notice in the **Federal Register** as soon as possible after the Administrator's determination to ensure full notification to all interested parties. *§ 211.45(e).* This paragraph identifies the required content of a petition for emergency waiver. To be considered under the emergency waiver procedures, FRA must first determine that the petition is directly related to the occurrence of, or imminent threat of an emergency event. FRA will base its determination on the information provided in the petition. Thus, the petition should contain information that sufficiently demonstrates the relationship between the emergency event and the waiver relief being sought. *§ 211.45(f).* This paragraph instructs the public how to submit a petition under the emergency waiver procedures. FRA is permitting submission by e-mail, fax, or mail. Permitting a variety of methods for submitting petitions for emergency waiver is intended to enhance the convenience and effectiveness of the process during the occurrence of, or imminent threat of an emergency event. *§ 211.45(g)* . This paragraph contains information regarding FRA's handling of waiver petitions under the emergency waiver procedures. After the FRA declares that the emergency procedures are in effect, it will accept petitions for emergency waivers. Petitions that are determined to be directly related to an emergency will be placed in the ERD for that year. The DMS numbers each document that is added to a docket. Thus, each petition submitted to the ERD will have a unique document number. For reference purposes, this document number should be identified on all communications related to that particular waiver petition. *§ 211.45(h)* . This paragraph explains the comment process. FRA believes that 72 hours is a reasonable length of time to consider comments in an emergency situation. During hurricane Katrina, public safety was well served by FRA's expedited emergency waiver procedures. Similarly, during future emergency situations the public interest will require an expedited review process to ensure public safety. FRA believes that the emergency waiver procedures and the need to quickly address these types of waiver petitions fall within the good cause exemption under section 553 of the Administrative Procedure Act relating to providing prior notice and comment. Nonetheless, FRA is providing notice to interested parties and is permitting a short comment period prior to taking any agency action. Moreover, FRA is providing an opportunity for a public hearing as soon as practicable after initial consideration of an emergency waiver petition. *§ 211.45(i).* This paragraph describes how FRA will handle requests for hearing. FRA believes that a telephone conference will provide interested parties with an opportunity to present evidence regarding a particular petition to a neutral decision maker. If a party requests a public hearing after the telephone conference, FRA will provide one as soon as practicable. During an emergency the public interest requires that an expedited waiver process be utilized. *§ 211.45(j)* . This paragraph identifies the process by which FRA will make decisions on emergency waivers including: FRA's consideration of the petition; notification to the public of FRA's decision; and the limits of any relief granted under the procedures. The ability to grant or deny a petition without delay is essential to ensuring public safety during an emergency. The opportunity to reconsider a petition after the initial decision is made will ensure a robust deliberation. Under circumstances where reconsideration is appropriate, FRA will utilize additional time to consider the parties' input. FRA's understanding of an emergency may change as the emergency event develops. Accordingly, the public will benefit from FRA's ability to reconsider decisions, and make appropriate adjustments based on further information. This will also ensure that FRA has the opportunity to address all relevant arguments made by interested parties anytime after its initial consideration of a petition. During an emergency it is a priority to address petitions for emergency waiver and make a decision without delay. Relevant comments may be submitted after the 72-hour comment period, and the public will benefit from ensuring that FRA has the opportunity to address those comments as soon as practicable. Posting the decision letters in the appropriate ERD will provide notice to interested parties. The DMS internet site that is identified in the rule text allows any interested party to subscribe, without fee, to its list serve application which will automatically notify the party via e-mail when documents are added, including the Administrator's determination that emergency waiver procedures are in effect, to the designated ERD. This paragraph also makes clear that any relief granted under these procedures will be limited to no more than nine months. If relief is needed for a period of time beyond nine months, a petition can be submitted through the traditional waiver process. Where issues of safety and security overlap, it may be necessary for FRA to coordinate with DHS. General Information Considering that the ERD and procedures for emergency waiver petitions are procedural modifications that will not change any regulatory requirements, together with the need to issue these procedural changes as soon as possible since we have entered the official hurricane season, FRA is issuing this document as an interim final rule with a request for comments. Congress authored a good cause exemption to the informal rulemaking procedures to address emergencies (such as a response to a natural disaster) that might arise justifying issuance of a rule without prior public participation. As hurricane season begins again, unfortunately, another emergency event could occur immediately. The public would benefit from having the emergency waiver procedures in place before the emergency exists. Delay in the adoption of these procedures for expediting waivers could cause serious harm to the public and the rail industry. In contrast to the potential harm that could be caused by delay, the impact of the procedural modifications on the public will be minimal. This rule merely expedites the already-existing waiver process during an emergency. Consequently, pursuant to 5 U.S.C. 553(b)(3)(B), FRA believes that good cause exists for finding that prior public notice of this action is both impracticable and unnecessary. However, FRA is requesting written comments on the content of this interim final rule and, if any are received, FRA will address them when issuing the final rule. Immediate action is necessary to avoid disruption to the rail industry during a future emergency. Delaying the effective date of this rule during hurricane season would be impracticable, unnecessary, and contrary to the public interest. The rule establishes procedures that will benefit the rail industry and general public during an emergency. Having expedited emergency waiver procedures available during a future emergency will allow FRA to make timely decisions and provide relief from safety regulations. Privacy All potential commenters should be aware that anyone is able to search the electronic form of all comments received into any agency docket by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* Regulatory Impact Executive Order 12866 and DOT Regulatory Policies and Procedures This interim final rule has been evaluated in accordance with Executive Order 12866 and DOT policies and procedures. The modifications contained in this interim final rule are not considered significant because they are intended to merely institute an emergency relief docket, and establish internal FRA procedures for handling waivers directly related to an emergency. This interim final rule will not change any regulatory requirements. The economic impact of the procedures and establishment of the docket contained in this interim final rule will not affect the cost of compliance with the existing regulations. Regulatory Flexibility Act The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 *et seq.* ) requires a review of rules to assess their impact on small entities. FRA certifies that this interim final rule does not have a significant impact on a substantial number of small entities. Because the procedures and the establishment of an emergency docket contained in this rule does not change regulatory requirements, FRA has concluded that there are no substantial economic impacts on small units of government, businesses, or other organizations. Paperwork Reduction Act This interim final rule does not change any of the information collection requirements. Environmental Impact FRA has evaluated this interim final rule in accordance with its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28545, May 26, 1999) as required by the National Environmental Policy Act (42 U.S.C. 4321 *et seq.* ), other environmental statutes, Executive Orders, and related regulatory requirements. FRA has determined that this document is not a major FRA action (requiring the preparation of an environmental impact statement or environmental assessment) because it is categorically excluded from detailed environmental review pursuant to section 4(c) of FRA's Procedures. Federalism Implications FRA believes it is in compliance with Executive Order 13132. Because the emergency docket and procedures for emergency waiver petitions will not change any regulatory requirements, this document will not have a substantial 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. This interim final rule will not have federalism implications that impose any direct compliance costs on State and local governments. Unfunded Mandates Reform Act of 1995 Pursuant to section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Section 202 of the Act (2 U.S.C. 1532) further requires that “before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $128,100,000 or more in any 1 year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement” detailing the effect on State, local, and tribal governments and the private sector. Because the ERD and procedures for emergency waiver petitions will not change any regulatory requirements, this document will not result in the expenditure, in the aggregate, of $128,100,000 or more in any one year, and thus preparation of such a statement is not required. Energy Impact Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” 66 FR 28355 ( May 22, 2001). Under the Executive Order, a “significant energy action” is defined as any action by an agency (normally published in the **Federal Register** ) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking: (1)(i) That is a significant regulatory action under Executive Order 12866 or any successor order, and

(ii)is likely to have a significant adverse effect on the supply, distribution, or use of energy; or

(2)that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. FRA has evaluated interim final rule in accordance with Executive Order 13211. Because the emergency docket and procedures for emergency waiver petitions will not change any regulatory requirements, FRA has determined that this document will not have a significant adverse effect on the supply, distribution, or use of energy. Consequently, FRA has determined that this regulatory action is not a “significant energy action” within the meaning of Executive Order 13211. List of Subjects in 49 CFR Part 211 Administrative practice and procedure, Railroad safety. Adoption of the Amendment In consideration of the foregoing, part 211 of Chapter II of Title 49 of the Code of Federal Regulations is amended to read as follows: PART 211—RULES OF PRACTICE 1. The authority citation for part 211 continues to read as follows: Authority: 49 U.S.C. 20103, 20107, 20114, 20306, 20502-20504, and 49 CFR 1.49. 2. Section 211.45 is added to subpart C to read as follows: § 211.45 Petitions for emergency waiver of safety rules.

(a)*General* . This section applies only to petitions for waiver of a safety rule, regulation, or standard that FRA determines are directly related to the occurrence of, or imminent threat of, an emergency event. For purposes of this section an emergency event could be local, regional, or national in scope and includes a natural or manmade disaster, such as a hurricane, flood, earthquake, mudslide, forest fire, significant snowstorm, terrorist act, biological outbreak, release of a dangerous radiological, chemical, or biological material, war-related activity, or other similar event.

(b)*Emergency Relief Docket* . Each calendar year FRA creates an Emergency Relief Docket

(ERD)in the publicly accessible DOT Document Management System (DMS). The DMS can be accessed 24 hours a day, seven days a week, via the Internet at the docket facility's Web site at *http://dms.dot.gov* . All documents in the DMS are available for inspection and copying on the Web site or are available for examination at the DOT Docket Management Facility, Room PL-401 (Plaza Level), 400 7th Street, SW., Washington, DC 20590 during regular business hours (9 a.m.-5 p.m.). By January 31st of each year, FRA publishes a notice in the **Federal Register** identifying by docket number the ERD for that year. A notice will also be published in the previous year's ERD identifying the new docket number.

(c)*Determining the existence of an emergency event* . If the Administrator determines that an emergency event identified in paragraph

(a)of this section has occurred, or that an imminent threat of it occurring exists, and determines that public safety or recovery efforts require that the provisions of this section be implemented, the Administrator will activate the Emergency Relief Docket identified in paragraph

(d)of this section. In determining whether an emergency exists, the Administrator may consider declarations of emergency made by local, state, or Federal officials, and determinations by Federal government that a credible threat of a terrorist attack exists.

(d)*Additional notification* . When possible, FRA will post the FRA Administrator's determination described in paragraph (b)(1) of this section on its Web site at *http://www.fra.dot.gov* . FRA will also publish a notice in the **Federal Register** alerting interested parties of the FRA Administrator's determination as soon as practicable.

(e)*Content of petitions for emergency waivers* . Petitions submitted to FRA pursuant to this section should specifically address how the petition is related to the emergency, and to the extent practicable, contain the information required under § 211.9(a) and (b). The petition should at a minimum describe the following: How the petitioner or public is affected by the emergency (including the impact on railroad operations); what FRA regulations are implicated by the emergency (e.g. movement of defective equipment); how waiver of the implicated regulations would benefit petitioner during the emergency; and how long the petitioner expects to be affected by the emergency.

(f)*Filing requirements* . Petitions filed under this section, shall be submitted using any of the following methods:

(1)Direct e-mail to FRA at: *RRS.Correspondence@fra.dot.gov;*

(2)Direct fax to FRA at: 202-493-6309; or

(3)To FRA Docket Clerk, Office of Chief Counsel, RCC-10, Mail Stop 10, 1120 Vermont Avenue, NW., Washington, DC 20590, fax no.

(202)493-6068.

(g)*FRA Handling and Initial Review* . Upon receipt and initial review of a petition for waiver, to verify that it meets the criteria for use of these emergency procedures, FRA will add the petition to the ERD. The DMS numbers each document that is added to a docket. (For example, the first document submitted to the docket in 2006 will be identified as FRA-2006-XXX-1.) Thus, each petition submitted to the ERD will have a unique document number which should be identified on all communications related to petitions contained in this docket. If FRA determines that the petition does not meet the criteria for use of these emergency procedures, FRA will notify the petitioner and will process the petition under normal waiver procedures of this subpart.

(h)*Comments.* Comments should be submitted within 72-hours from the time the petition is entered into and available on the DMS. Any comment received after that period will be considered to the extent practicable. All comments should identify the appropriate ERD and should identify the specific document number of the petition designated by the DMS in the ERD. Interested parties commenting on a petition under this section should also include in their comments to the ERD telephone numbers at which their representatives may be reached. Interested parties may submit their comments using any of the following methods:

(1)Direct e-mail to FRA at: *RRS.Correspondence@fra.dot.gov.*

(2)Direct fax to FRA at: 202-493-6309.

(3)Submission of comments to the Docket Clerk, DOT Docket Management Facility, Room PL-401 (Plaza Level), 400 7th Street, SW., Washington, DC 20590 or electronically via the Internet at *http://dms.dot.gov* . Any comments or information sent directly to FRA will be immediately provided to the DOT DMS for inclusion in the ERD.

(i)*Request for hearing* . Parties desiring a public hearing on any petition being processed under this section must notify FRA through the comment process identified in paragraph

(h)of this section within 72-hours from the time the petition is entered into and available on the DMS. In response to a request for a public hearing, FRA will arrange a telephone conference between all interested parties to provide an opportunity for oral comment. The conference will be arranged as soon as practicable. After such conference, if a party stills desires a public hearing on the petition, then a public hearing will be arranged as soon as practicable pursuant to the provisions contained in 49 CFR part 211.

(j)*Decisions* . FRA may grant a petition for waiver prior to conducting a public hearing if such action is in the public interest and consistent with safety or in situations where a hearing request is received subsequent to the 72-hour comment period. In such an instance, FRA will notify the party requesting the public hearing of its decision and will arrange to conduct such hearing as soon as practicable.

(1)FRA reserves the right to reopen any docket and reconsider any decision made pursuant to these emergency procedures based upon its own initiative or based upon information or comments received subsequent to the 72-hour comment period or at a later scheduled public hearing.

(2)FRA decision letters, either granting or denying a petition, will be posted in the appropriate ERD and will reference the document number of the petition to which it relates.

(3)Relief granted shall not extend for more than nine months.

(4)For matters that may significantly impact the missions of the Department of Homeland Security, FRA consults with the Department of Homeland Security as soon as practicable. Issued in Washington, DC on August 28, 2006. Joseph H. Boardman, Federal Railroad Administrator. [FR Doc. 06-7292 Filed 8-28-06; 1:22 pm]

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