Fed. Reg. Rules and Regulations — Final rule

BILLING CODE 6560-50-M ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0121; FRL-7713-1] Pythium Oligandrum DV 74; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of *Pythium oligandrum* DV 74 on food crops. Biopreparaty Co. Ltd. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance.

This regulation eliminates the need to establish a maximum permissible level for residues of *Pythium oligandrum* DV 74. DATES: This regulation is effective May 16, 2007. Objections and requests for hearings must be received on or before July 16, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2005-EPA-0121. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* ,or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg., 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Tessa Milofsky, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-0455; e-mail address: *milofsky.tessa@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 code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions. 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* . 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-EPA-0121 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 July 16, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2005-EPA-0121, by one of the following methods. • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of May 25, 2005 (70 FR 30105) (FRL-7713-1). EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 4F6877) by Biopreparaty, Co. Ltd. Tylisovska I, Prague 6, Czech Republic. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement * Pythium oligandrum * DV 74. This notice included a summary of the petition prepared by the petitioner Biopreparaty Co. Ltd. One comment was received from a private citizen opposing the “production or selling” of *Pythium oligandrum* DV 74. The commentor further stated that it was their wish that no exemptions be issued and that no tolerances should be approved. The Agency understands the commentor's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, under the existing legal framework provided by section 408 of the FFDCA EPA is required to establish pesticide tolerances or exemptions where persons seeking such exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The commentor has not provided the Agency with a specific rationale or additional information pertaining to the legal standards in FFDCA section 408 for opposing the establishment of a tolerance exemption for *Pythium oligandrum* DV 74. In the absence of any additional information of a factual nature, the Agency can not effectively respond to the commentor's disagreement with the Agency's decision. Another comment was received that supported the registration. The commentator stated that “ *Pythium oligandrum* appears to be an unusually effective (in its rapidity of action) and exceptionally safe (in terms of mammalian toxicity) crop protection product.” Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require 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. . . . ” Additionally, section 408(b)(2)(D) of the FFDCA requires that 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.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information 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. A. Acute Oral Toxicity and Pathogenicity (Master Record Identification numbers 464107-02 and 464109-03; Data Request 152-30; OPPTS Harmonize Guideline. 885.3050) A guideline acute oral toxicity study was carried out in 2001 using mice. Ten mice (five males, five females) were given a total dose of 5,000 milligrams/kilogram (mg/kg) *Pythium oligandrum* DV 74 and no adverse effects were seen in the mice which were observed for 14 days after dosing. The test substance was rated *Toxicity Category IV* . B. Acute Dermal Toxicity (Master Record Identification numbers 464109-04, 464107-02; OPPTS Harmonize Guideline 870.1200) A guideline acute dermal toxicity study was conducted using rats. The dermal LD 50 for males, females, and combined was greater than 5,000 mg/kg body wt. *Pythium oligandrum* DV 74 test substance was rated *Toxicity Category IV* . C. Acute Inhalation Toxicity (Master Record Identification number 464109-05; OPPTS Harmonize Guideline 870.1300) In a four-hour acute inhalation toxicity study using rats, a limit dose (5 mg/L) of *Pythium oligandrum* DV 74 produced no mortality nor adverse effects, and no gross abnormalities were seen at necropsy 14 days later. Although the MMD was 7.45 and µm, approximately 68% of the particles were ≤3.75 µm. The acute inhalation LC 50 for males, females, and combined was >5 mg/L for a 4 hour exposure. The test substance is *Toxicity Category IV* . D. Acute Pulmonary Toxicity/Pathogenicity-Waiver Granted (Master Record Identification number 464109-10; OPPTS Harmonize Guideline 885.3150) In a four-hour acute inhalation toxicity study using rats, a limit dose (5 mg/L) of *Pythium oligandrum* DV 74 produced no mortality or adverse effects, and no gross abnormalities were seen at necropsy 14 days later. Although the MMD was 7.45 µm, approximately 68% of the particles were ≤3.75 µm. The acute inhalation LC 50 for males, females, and combined was >5 mg/L for a 4 hour exposure. The test substance is classified as *Toxicity Category IV* . Infectivity testing was waived for this study based on the results of the growth temperature study which showed no growth on plant-based growth media at or above 37° C, and no growth at any temperature on animal tissue-based growth media. E. Acute Injection Tocity/Pathogenicity (Master Record Identification numbers 465823-01, 467542-01,464109-10, and 469901-01; OPPTS Harmonize Guideline 885.3200) An acute injection toxicity/pathogenicity study was conducted using rats. Storage, stability data showed that after Batch No. 150405 was stored for approximately 9 months, of 1.3x10 6 oospores/g active ingredient 80.5% were viable after 120 hours incubation, giving 1.1x10 6 cfu/g - however, this study lists Batch No. 150405 as containing 10 7 granules/g, so viability would then be only 11%. Based on the data submitted, *Pythium oligandrum* DV 74 does not appear toxic nor pathogenic to rats when dosed at 2.9x10 4 oospores/animal - although no attempts to isolate viable organisms prior to testing, or from test animals after inoculation, were made. Therefore, infectivity cannot be assessed in the study, initially rated not toxic nor pathogenic. In addition, there were discrepancies with characterization of the test substance. However, infectivity testing was waived for this study, based on the results of the growth temperature study which showed no growth on plant-based growth media at or above 37° C, and no growth at any temperature on animal tissue-based growth media. F. Primary Dermal Irritation (Master Record Identification numbers 464605-02 and 464107-02; OPPTS Harmonize Guideline 870.2500) An acute dermal irritation study was conducted using rabbits. Very slight erythema was noted on the skin of three rabbits one hour after patch removal, with clearance on two rabbits by 24 hours and on one rabbit by 48 hours. The primary irritation index was 0.3. Technical DV 74 was essentially nonirritating; the test substance was rated *Toxicity Category IV* . G. Acute Eye Irritation (Master Record Identification number 464109-06;OPPTS Harmonize Guideline 870.2400) An acute eye irritation study was conducted using rabbits. No corneal opacity nor iritis was observed during the study. Positive conjunctival irritation (score 2) was noted on 2 rabbits 1 hour after *Pythium oligandrum* DV 74 instillation with resolution by 48 hours. The maximum average score was 6.7 at 24 hours after test material instillation. The test substance is *Toxicity Category III* . H. Skin sensitization-Waiver Granted (Master Record Identification number 464109-10; OPPTS Harmonize Guideline 870.2600) A guideline acute dermal toxicity study was conducted using rats. The dermal LD 50 for males, females, and combined was greater than 5,000 mg/kg body wt. *Pythium oligandrum* DV 74 and rated *Toxicity Category IV* . An acute dermal irritation study was conducted using rabbits. Very slight erythema was noted on 3/3 rabbits one hour after patch removal, with clearance on two rabbits by 24 hours and on one rabbit by 48 hours. The primary irritation index was 0.3. Technical DV 74 was essentially nonirritating and rated *Toxicity Caterogy IV* . In addition, *Pythium oligandrum* occurs naturally in a variety of soil types over a wide range of environmental conditions. Although application of *Pythium oligandrum* DV 74 to seeds, foliage, or soil will likely temporarily increase its concentration in the environment, the population is expected to subside to normal levels, because the organism does not thrive in the absence of sufficient nutrients. A search of the public literature found no reports of *Pythium oligandrum* having adverse effects in humans or other mammals. The only known biological effects of *Pythium oligandrum* are parasitic effects on fungal species and stimulation of resistance to parasitic infection in plants. Neither the mechanism of the mycoparasitic action nor the stimulation of plant resistance is associated with adverse effects in mammals. *Pythium oligandrum* DV 74 is the active ingredient in various over-the-counter products sold in Europe, including a mouthwash, a bath additive and a skin cream. These products have been on the market in parts of the EU since 1999 with no reported adverse effects. The lack of any reported sensitization effects from repeated dermal exposure to the consumer products suggests that *Pythium oligandrum* is not a dermal sensitizer. To reduce exposure to this active ingredient from its pesticide use, the agricultural use label requires that applicators and handlers wear a long-sleeved shirt and long pants, waterproof gloves, and shoes plus socks. I. Pathogenicity and Infectivity (Master Record Identification numbers 469901-01 and 02) *Pythium oligandrum* DV 74 is primarily a fungal hyperparasite that exhibits limited growth on plant-based media and no growth on animal tissue-based media. In addition, its growth tapers off as temperature approaches normal human body temperature of 37° C and there is no growth at or above this temperature. Therefore, infectivity testing is not possible. This information supports waivers for infectivity testing in the acute oral, acute dermal, acute inhalation, and injection exposure studies. J. Subchronic, Chronic Toxicity and Oncogenicity Based on the data generated in accordance with Tier I data requirements (40 CFR 158.740(c)), Tier II tests (Guidelines 152B-40 through 152B-49), which include acute oral, acute inhalation, subchronic oral, acute intraperitoneal/intracerebral, primary dermal, primary eye, immune response, teratogenicity, virulence enhancement, and mammalian mutagenicity were not required. Tier III tests (Guidelines 152-50 through 53), which include chronic testing, oncogenicity testing, mutagenicity, and teratogenicity were also not required. K. Effects on the Endocrine System EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.” *Pythium oligandrum* is not a known endocrine disruptor nor is it related to any class of known endocrine disruptors. Consequently, endocrine-related concerns did not adversely impact the Agency's safety finding for *Pythium oligandrum* . IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure Due to the proposed use of *Pythium oligandrum* on food crops, fungal residues may be present on agricultural commodities. However, negligible to no risk is expected for the general population, including infants and children, because *Pythium oligandrum* demonstrated no pathogenicity nor acute oral toxicity at the maximum doses tested. 1. *Food* . Due to the proposed use of *Pythium oligandrum* on food crops, fungal residues may be present on agricultural commodities. However, negligible to no risk is expected for the general population, including infants and children, because *Pythium oligandrum* demonstrated no pathogenicity or oral toxicity at the maximum doses tested. 2. *Drinking water exposure* . *Pythium oligandrum* does not thrive in aquatic environments and there are no aquatic use sites for the pesticide. Accordingly, application of this pesticide to approved use sites is not expected to increase drinking water exposure to *Pythium oligandrum* . Furthermore, any *Pythium oligandrum* that might be consumed through drinking water would pose negligible to the general population, including infants and children, due to the pesticide's low toxicity classification. B. Other Non-Occupational Exposure *Pythium oligandrum* will be applied to agricultural fields, turf and professional landscapes, and in home gardens. Although some applications may be made near residential areas, no harm would be expected to result from exposure to *Pythium oligandrum* due to its low toxicity classification. 1. *Dermal exposure* . Dermal exposure is limited by use of the required PPE and REI in occupational settings, and residential users are advised to avoid skin contact and to wash any exposed skin or clothing. 2. *Inhalation exposure* . The greatest likelihood of inhalation exposure would occur in an occupational setting, among mixers/loaders and applicators. However, as demonstrated in the acute pulmonary toxicity/pathogenicity test, *Pythium oligandrum* is not infective, pathogenic, or toxic to mammals. Despite the benign nature of the active ingredient, the agency requires that all workers exposed to microbial pesticides must wear a dust/mist filtering respirator. As such, the risks anticipated for inhalation exposure are minimal. V. Cumulative Effects Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to consider the cumulative effect of exposure to *Pythium oligandrum* and to other substances that have a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. As demonstrated in Unit III.A., *Pythium oligandrum* is not toxic or pathogenic to mammals, and only minimally irritating to eyes. Consequently, no cumulative effects from the residues of this product with other related microbial pesticides are anticipated. VI. Determination of Safety for U.S. Population, Infants and Children There is a reasonable certainty that no harm to the U.S. population, including infants and children, will result from aggregate exposure to residues of *Pythium oligandrum* due to its use as a microbial pest control agent. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed in Unit III.A., *Pythium oligandrum* is not toxic or pathogenic to mammals, and only minimally irritating in an eye exposure study. Accordingly, exempting *Pythium oligandrum* from the requirement of a tolerance is considered safe and poses no significant risks. FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of exposure (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 that a different margin of exposure (safety) will be safe for infants and children. Margins of exposure (safety), which often are referred to as uncertainty factors, are incorporated into EPA risk assessment either directly or through the use of a margin of exposure analysis or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk. Actual exposures to adults and children through diet are expected to be several orders of magnitude less than the doses used in the toxicity and pathogenicity tests referenced in Unit III. Thus, the Agency has determined that an additional margin of safety for infants and children is unnecessary. VII. Other Considerations A. Endocrine Disruptors EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.” *Pythium oligandrum* is not a known endocrine disruptor nor is it related to any class of known endocrine disruptors. Consequently, endocrine-related concerns did not adversely impact the Agency's safety finding for *Pythium oligandrum* . B. Analytical Method(s) The acute oral toxicity and pathogenicity findings discussed in Unit III demonstrate that the active ingredient does not pose a dietary risk. Nevertheless, the Agency has concluded that for the analysis of the pesticide itself, microbiological and biochemical methods exist and are acceptable for the enforcement purposes for product identity of *Pythium oligandrum* DV 74. Other appropriate methods are required for quality control to assure that product characterization, the control of human pathogens, and other unintentional metabolites or ingredients are within regulatory limits, and to ascertain storage stability and viability of the pesticidal active ingredient. C. Codex Maximum Residue Level There is no established Codex maximum residue level for residues of *Pythium oligandrum* DV 74. VIII. Conclusions The results of the studies discussed are sufficient to comply with the requirements of FQPA. They support an exemption from the requirement of tolerance for residues of *Pythium oligandrum* DV 74, on treated food of food commodities. In addition, the Agency is of the opinion that, if the microbial active ingredient is used as allowed, aggregate and cumulative exposures are not likely to pose any undue hazard to the U.S. population of adult, children, and infant humans. Therefore, an exemption from the requirement of tolerance is granted in response to pesticide petition 4F6877. IX. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled * Consultation and Coordination with Indian Tribal Governments * (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). X. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 4, 2007. Debra Edwards, Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 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 180.1275 is added to subpart D to read as follows: § 180.1275 Pythium; Exception from the requirement of a tolerance. An exemption from the requirement of tolerance is established on all food/feed commodities, for residues of *pythium oligandrum* DV 74 when the pesticide is used on food crops. [FR Doc. E7-9298 Filed 5-15-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0800; FRL-8128-2] Chlorantraniliprole; Time-Limited Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes time-limited tolerances for residues of chlorantraniliprole in or on apple and apple, wet pomace, celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon commodities. DuPont Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The tolerances will expire on May 1, 2010. DATES: This regulation is effective May 16, 2007. Objections and requests for hearings must be received on or before July 16, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0800. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Public Docket, in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703 306-0415; e-mail address: *kable.davis@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 code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions discussed above. 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* . 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-2006-0800 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 July 16, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0800, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of October 13, 2006 (71 FR 198) (FRL-8096-2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6G7089) by E I. DuPont de Nemours and Company, DuPont Crop Protection, 1090 Elkton Road, Newark, Delaware 19711. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide chlorantraniliprole, 3-bromo- *N* -[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on apple at 0.3 parts per million (ppm), apple, celery at 7.0 ppm, cucumber at 0.09 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 7.5 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.25 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. This notice referenced a summary of the petition prepared by E.I. DuPont de Nemours and Company, DuPont Crop Protection, the registrant, which has been included in the public docket. Several comments were received from a private citizen on objecting to pesticide body load, IR-4 profiteering, animal testing, and other related matters. The Agency has received these same comments from this commenter on numerous previous occasions. Refer to the **Federal Register** of June 30, 2005 (70 FR 37686) (FRL-7718-3), January 7, 2005 (70 FR 1354) (FRL-7691-4), and October 29, 2004 69 FR 63096 for the Agency's response to these objections. These temporary tolerances will permit the marketing of the above raw agricultural commodities when treated in accordance with the provisions of the experimental use permits 352-EUP-170, and 353-EUP-171, which are being issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). The scientific data reported and other relevant material were evaluated, and it was determined that establishment of these temporary tolerances will protect the public health. Therefore, these temporary tolerances have been established on the condition that the pesticide be used in accordance with the experimental use permits. The tolerances will expire on May 1, 2010. Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” 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 the 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 the FFDCA , for tolerances for residues of chlorantraniliprole on apple at 0.25 ppm, apple, wet pomace at 0.60 ppm, celery at 7.0 ppm, cucumber at 0.10 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 8.0 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.40 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by chlorantraniliprole 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 in Docket ID EPA-HQ-OPP-2006-0800. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which 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 of concern are 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 chlorantraniliprole used for human risk assessment can be found at www.regulations.gov in Docket ID EPA-HQ-OPP-2006-0800. C. Exposure Assessment 1. *Dietary exposure from food and feed uses.* Chlorantraniliprole is a new active ingredient and tolerances have not been established. A risk assessment was conducted by EPA to assess dietary exposures from chlorantraniliprole in food (from crops treated under the experimental permits) 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 one day or single exposure. Acute dietary (food and drinking water) exposure assessments were conducted for chlorantraniliprole using the Dietary Exposure Evaluation Model (DEEM-FCID), and reflect the proposed uses on apple, celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon crops. The modeled exposure estimates are based on tolerance level residues (calculated using the maximum residue level calculator) assuming 100% of crops are treated and surface water estimated drinking water concentrations (EDWCs) (because surface water EDWCs were higher than ground water EDWCs). ii. *Chronic exposure* . Chronic dietary (food and drinking water) exposure assessments were conducted for chlorantraniliprole using the DEEM-FCID), and reflect the proposed uses on apple, celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon crops. The modeled exposure estimates are based on tolerance level residues (calculated using the maximum residue level calculator) assuming 100% of crops are treated and surface water estimated drinking water concentrations (EDWCs) (because surface water EDWCs were higher than ground water EDWCs). iii. *Cancer* . Long-term exposure is not expected to result from use under these Experimental Use Permits (EUPs). The submitted subchronic studies in mice, dog and rats, and the in vivo and in vitro genotoxicity studies, identified no tumors or preneoplastic foci, nor did they identify mutagenic concern. Therefore, the expected short/intermediate-term exposure resulting from the EUPs does not indicate a concern for carcinogenicity. 2. *Dietary exposure from drinking water* . Clorantraniliprole is an unregistered chemical, thus, the Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for chlorantraniliprole 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 chlorantraniliprole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the EPA's pesticide root zone model/exposure analysis modeling system (PRZM/EXAMS) and screening concentration in groundwater (SCI-GROW) models, the estimated environmental concentrations

(EECs)of chlorantraniliprole for acute exposures are estimated to be 14 ppb for surface water and 0.38 ppb for ground water. The EECs for chronic exposures are estimated to be 2.3 ppb for surface water and 0.38 for ground 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). Chlorantraniliprole is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and“ other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to chlorantraniliprole and any other substances and chlorantraniliprole 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 chlorantraniliprole 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 the 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 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 margin of exposure

(MOE)analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. *Prenatal and postnatal sensitivity* . There were no effects on fetal growth or development up to the limit dose of 1,000 milligrams killogram day (mg/kg/day) in rats or rabbits. There were no treatment related effects on the numbers of litters, fetuses (live or dead), resorptions, sex ratio, or post-implantation loss. There were no effects on fetal body weights, skeletal ossification, and external, visceral, or skeletal malformations or variations. 3. *Conclusion* . Due to the following, the FQPA Safety Factor does not need to be retained at this time: The toxicology database is complete for the characterization of potential prenatal and postnatal risks to infants and children. No susceptibility was identified in the toxicological data base, and there are no residual uncertainties re: prenatal and/or postnatal exposure (i.e., the developmental and reproduction studies report no adverse effects related to treatment ≥ 1,000 mg/kg/day limit dose). Therefore, a degree of concern analysis for prenatal and/or postnatal susceptibility is not necessary. Highly conservative dietary (food and water) exposure estimates are at least 60,000 times lower than the highest dose tested in the mammalian toxicity studies (at which no adverse observed effects were seen). E. Aggregate Risks and Determination of Safety 1. *Acute/chronic risk* . Aggregating routes and/or pathways of exposure is not relevant, since no hazard was identified via any route of exposure in the EUP toxicology data base. 2. *Short/Intermediate-term risk* . Chlorantraniliprole is not registered for use on any sites that would result in short and intermediate residential exposure and therefore no risk assessment was conducted for this scenario. 3. *Aggregate cancer risk for U.S. population* . Long-term exposure is not expected to result from use under these EUPs. The submitted subchronic studies in mice, dog and rats, and the *in vivo* and *in vitro* genotoxicity studies, identified no tumors or preneoplastic foci, nor did they identify mutagenic concern. 4. *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 chlorantraniliprole residues. IV. Other Considerations A. Analytical Enforcement Methodology LC/MS/MS methods are available for measuring chlorantraniliprole in plants and livestock. The registrant submitted an LC/MS/MS method for the determination of chlorantraniliprole in plants, and an LC/MS/MS method for the determination of chlorantraniliprole and its metabolites in livestock. Adequate method and concurrent recovery data were provided for the plant LC/MS/MS method, and the fortification levels used in the method and concurrent validation are adequate to bracket the residue levels determined in the proposed crops. An analytical method for enforcing tolerances in livestock commodities is not germane to this EUP as tolerances in meat, milk, poultry and eggs are not required. B. International Residue Limits There are currently no established Codex, Canadian, or Mexican MRLs for chlorantraniliprole. C. Conditions None. V. Conclusion Therefore, time-limited tolerances are established for residues of chlorantraniliprole, 3-bromo- *N* -[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on apple at 0.25 ppm, apple, wet pomace at 0.60 ppm, celery at 7.0 ppm, cucumber at 0.10 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 8.0 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.40 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. These tolerances will expire on May 1, 2010. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 2, 2007. Debra Edwards, Director, 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 180.628 is added to read as follows: §180.628 Chlorantraniliprole; tolerances for residues.

(a)Tolerances are established for residues of the pesticide chlorantraniliprole (3-bromo- *N* -[4-chloro-2-methyl-6- [(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide) in or on the following raw agricultural commodities: Commodity Parts per million Expiration/revocation date Apple 0.25 05/01/2010 Apple, wet pomace 0.60 05/01/2010 Celery 7.0 05/01/2010 Cucumber 0.10 05/01/2010 Lettuce, head 4.0 05/01/2010 Lettuce, leaf 8.0 05/01/2010 Pear 0.30 05/01/2010 Pepper 0.50 05/01/2010 Spinach 13.0 05/01/2010 Squash 0.40 05/01/2010 Tomato 0.30 05/01/2010 Watermelon 0.20 05/01/2010

(b)*Section 18 emergency exemptions.* [Reserved]

(c)*Tolerances with regional registrations.* [Reserved]

(d)*Indirect or inadvertent residues* . [Reserved] [FR Doc. E7-9206 Filed 5-15-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0995; FRL-8120-2] Pendimethalin; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for combined residues of pendimethalin and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol in or on beans; beans, forage; beans, hay; and peas (except field peas) to replace the current tolerances for bean, lima, seed; bean, lima, succulent; bean, forage; bean, hay; and pea, succulent. BASF Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 16, 2007. Objections and requests for hearings must be received on or before July 16, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0995. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* ,or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

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

(703)305-6663; e-mail address: *errico.philip@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0995 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before July 16, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0995, by one of the following methods: • *Federal eRulemaking Portal:* *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Petition for Tolerance In the **Federal Register** of January 24, 2007 (72 FR 3130) (FRL-8109-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7149) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.361 be amended by establishing a tolerance for combined residues of the herbicide, pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on beans; beans, forage; beans, hay; and peas (except field peas) each at 0.1 parts per million (ppm). That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. These proposed tolerances seek to correct an inadvertent error made by EPA in 2001 when EPA amended the pendimethalin beans and peas tolerances following completion of the pendimethalin reregistration eligibility determination under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 *et seq* ., and FFDCA tolerance reassessment. (66 FR 63192, December 5, 2001). In an attempt to clarify the coverage of the then existing beans and peas tolerances, EPA mistakenly narrowed the scope of the existing tolerances. This action re-establishes the beans and peas tolerances with the same coverage that pre-dated the 2001 amendments and using the terms originally recommended by the tolerance reassessment decision. Specifically, the proposed amendments to the pendimethalin tolerance would replace the current tolerances for bean, lima, seed; bean, lima, succulent; bean, forage; bean, hay; with tolerances for beans; beans, forage; beans, hay and the current tolerance for pea, succulent with a tolerance for peas (except field peas). The terms beans and peas are defined under 40 CFR 180.1(g) to encompass bean and pea commodities not covered by the current tolerances. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act

(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for combined residues of pendimethalin and its metabolite on beans; beans, forage; beans, hay; and peas (except field peas) each at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by pendimethalin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2006-0995 in that docket. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern

(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors

(UF)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose

(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure

(MOE)called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for pendimethalin used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of April 12, 2006 (71 FR 18628) (FRL-7770-4). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to pendimethalin, EPA considered exposure under the petition for tolerances as well as all existing pendimethalin tolerances in (40 CFR 180.361). EPA assessed dietary exposures from pendimethalin in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for pendimethalin; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. iii. *Cancer* . Pendimethalin is classified “Group C”, possible human carcinogen, chemical based on a statistically significant increased trend and pair-wise comparison between the high dose group and controls for thyroid follicular cell adenomas in male and female rats. The Agency used a non-quantitative approach (i.e., non-linear, RfD approach) since mode of action studies are available that demonstrate that the thyroid tumors are due to a thyroid-pituitary imbalance, and also since pendimethalin was shown to be non-mutagenic in mammalian somatic cells and germ. The chronic risk assessment is considered to be protective of any cancer effects; therefore, a separate quantitative cancer aggregate risk assessment is not required. iv. *Anticipated residue and percent crop treated

(PCT)information* . Tolerance level residues were assumed for all food commodities with current and proposed pendimethalin tolerances, and it was assumed that all of the crops included in the analysis were treated (i.e. 100% crop treated). 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for pendimethalin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of pendimethalin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-GROW) models, the estimated environmental concentrations

(EECs)of pendimethalin for peak exposures are estimated to be 39 parts per billion

(ppb)for surface water and 0.024 ppb for ground water. The EECs for chronic exposures are estimated to be 4.8 ppb for surface water and 0.024 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 39 ppb was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Pendimethalin is currently registered for the following residential non-dietary sites: Landscape, grounds plantings, ornamental crops, turf grass, and lawns. EPA assessed residential exposure using the following assumptions: Exposures are short-term in duration, and consist of dermal (for adults and children), and oral (hand-to-mouth, object-to-mouth, and soil ingestion, for children only). The Agency combines risk values resulting from separate exposure scenarios when it is likely they can occur simultaneously, based on the use-pattern and the behavior associated with the exposed population. The LOC for oral, dermal and inhalation exposure is an MOE of less than 300. The residential exposure estimate for adults, consisting of dermal exposure only, results in a total MOE of 740, and is therefore not of concern. The residential exposure for children results in a total MOE (dermal + oral) of 410 at an application rate of 2 lb ai/acre, and an MOE of 400 for an application rate of 3 lb ai/acre. Residential aggregate exposure is not of concern. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to pendimethalin and any other substances and pendimethalin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that pendimethalin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional

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

(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure

(MOE)called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. *Acute risk* . No toxic effects attributable to a single dose were identified for pendimethalin. Therefore, an acute risk assessment is not warranted for this chemical. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pendimethalin from food and water will utilize 26% of the cPAD for the population group children 1-2. Based the use pattern, chronic residential exposure to residues of pendimethalin is not expected. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pendimethalin is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for pendimethalin. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of 580 for adult males, 520 for adult females, 310 for children for an application rate of 2 lbs ai/acre to residential turf, and 300 for children for an application rate of 3 lbs ai/acre to residential turf. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Based on currently requested uses, there are no scenarios that are likely to result in intermediate-term exposure (30 to 180 days, continuous. Therefore, an intermediate-term risk assessment was not conducted. 5. *Aggregate cancer risk for U.S. population* . The Agency classifies pendimethalin as a “Group C” (possible human) cancinogen based on thyroid follicular cell adenomas in rats. A non-quantitative approach, non-linear RfD approach is used to assess the cancer risk using a chronic assessment, which is considerated protective of any cancer effects: Because exposure to pendimethalin does not exceed the chronic RfD, pendimethalin is not expected to pose a cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pendimethalin residues. IV. Other Considerations A. Analytical Enforcement Methodology Enforcement analytical methods using gas chromatography and an electron capture detector are available in the Pesticide Analytical Manual, Volume II. B. International Residue Limits There are no established or proposed Codex Maximum Residue Levles

(MRLs)for pendimethalin residues. Therefore, there are no questions of compatibility with respect to Codex MRLs and U.S. tolerances. C. Response to Comments There were no responses to the Notice of Filing for the requested tolerance in beans and peas. V. Conclusion Therefore, the tolerance is established for combined residues of pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on beans; beans, forage; beans, hay; and peas (except field peas) all at 0.1 ppm each. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, * Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use * (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 8, 2007. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. 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 180.361 is amended by revising the tolerances for “Bean, lima, seed”; “Bean, lima, succulent”; “Bean, forage”; “Bean, hay”; and “Pea, succulent“, which will be revoked due to an administrative error, with the entries to the table in paragraph

(a)to read as follows: § 180.361 Pendimethalin; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Beans 0.10 Beans, forage 0.10 Beans, hay 0.10 * * * * * Peas (except field peas) 0.10 * * * * * [FR Doc. E7-9428 Filed 5-15-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0160; FRL-8130-6] Aspergillus flavus NRRL 21882 on Corn; Temporary Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the *Aspergillus flavus* NRRL 21882 on corn when applied aerially once per season at the first sign of corn tasseling to reduce aflatoxin-producing *Aspergillus flavus* . Acta Group, 1203 Nineteenth St., NW., Suite 300, Washington, DC 20036-2401 on behalf of Circle One Global, Inc. One Arthur St. P.O. Box 28, Shellman, GA 39886-0028 submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of *Aspergillus flavus* NRRL 21882. The temporary tolerance exemption expires on May 2, 2009. DATES: This regulation is effective May 16, 2007. Objections and requests for hearings must be received on or before June 15, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2007-0160. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-8097; e-mail address: *bacchus.shanaz@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 code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Section 5 of FIFRA and the regulations promulgated to carry out that provision of FIFRA (40 CFR part 172). 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* . 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-2007-0160 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 July 16, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0160, by one of the following methods. • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of March 21, 2007 (72 FR 13277-13279) (FRL-8117-4), 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 tolerance petition (PP 6F7121) by Acta Group, 1203 Nineteenth St., NW., Suite 300, Washington, DC 20036-2401 on behalf of Circle One Global, Inc. P.O. Box 28, Shellman, GA 39886-0028. The petition requested that 40 CFR part 180 be amended to include a temporary exemption from the requirement of a tolerance for residues of *Aspergillus flavus* NRRL 21882 on corn. This notice included a summary of the petition prepared by the petitioner Acta Group, on behalf of Circle One Global, Inc. No comments were received in response to the **Federal Register** Notice. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(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. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require 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. . . .” Additionally, section 408(b)(2)(D) of FFDCA requires that 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.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile 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 and considered its validity, completeness and reliability and the relationship of this information 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. *Aspergillus flavus* NRRL 21882 is a non-aflatoxin-producing fungal active ingredient that will be used to displace the ubiquitous *Aspergillus flavus* group of microbes, many of which can produce aflatoxin, a potent carcinogen. The toxicological profile of this conditionally registered active ingredient has been previously described in the final rule of the **Federal Register** of June 30, 2004, (69 FR 39341) (FRL-7364-2). On the basis of those studies, the exemption from tolerance of *Aspergillus flavus* NRRL 21882, a non-aflatoxin-producing strain of *Aspergillus flavus* , on peanuts was established in 40 CFR 180.1254. The acute toxicology oral studies placed *Aspergillus flavus* NRRL 21882 in Toxicity Category IV. This active ingredient was not toxic, infective or pathogenic to mammals on the basis of acute oral, pulmonary and intraperitoneal studies. That database supporting the exemption from tolerance on peanut also supports the proposed temporary exemption of this active ingredient on corn. For a summary of the studies and discussions of dietary and non-dietary, non-occupational dermal and inhalation exposures, as well as aggregate and cumulative, exposures, and potential endocrine effects refer to the aforesaid June 30, 2004 final rule. All studies met the safety standards of the Food Quality Protection Act of 1996. This pesticide has been used for more than a decade in experimental laboratory and field trials without any reports of adverse dermal irritation or hypersensitivity effects. The petitioner is now requesting that those studies be also used as the basis to amend the tolerance exemption to include a temporary exemption from tolerance for *Aspergillus flavus* NRRL 21882 on corn during the Experimental Use Permit with EPA Registration Number (EPA Reg. No.) 75624-EUP-2. The proposed two-year, non-crop destruct Experimental Use Permit is for treatment of approximately 6,000 acres of corn grown for grain in Texas at ten or 20 pounds of the End-use Product

(EP)aflaguard R per acre. The Agency has determined that the studies do support the proposed exemption from tolerance of *Aspergillus flavus* NRRL 21882 on corn. Summaries of the rationales for this determination may be found in the aforesaid **Federal Register** Final Rule of June 30, 2004. No further toxicological data are required for this temporary exemption from the requirement of a tolerance for *Aspergillus flavus* NRRL 21882 on corn. The applicant must, however, report any incidents of hypersensitivity, or any other adverse effects to comply with the requirements of Section 6(a)(2). Efficacy data to demonstrate that the pesticide does reduce aflatoxin-producing *Aspergillus flavus* colonies and, concomitantly, aflatoxin in corn, are required as part of the Experimental Use Permit. IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure 1. *Food* . The aforesaid final rule for the exemption from tolerance for residues of *Aspergillus flavus* NRRL 21882 on peanut considered all studies submitted by the applicant and found them to be acceptable. 2. *Drinking water exposure* . Those data are also acceptable to demonstrate that the proposed use of *Aspergillus flavus* NRRL 21882 on corn will not harm the U.S. adult, infant and children population from dietary exposure, including food, and drinking water. Percolation through the soil and municipal treatment of drinking water are expected to preclude exposure of the US population, infants and children to residues of the pesticide. B. Other Non-Occupational Exposure 1. *Dermal exposure* . Dermal non-occupational exposure is expected to be minimal to non-existent for the proposed use of *Aspergillus flavus* NRRL 21882 on corn. The pesticide is to be applied to agricultural sites not in the proximity of residential areas, schools, nursing homes or daycares. 2. *Inhalation exposure* . For the same reasons non-occupational inhalation exposure to *Aspergillus flavus* NRRL 21882 is expected to be minimal to non-existent. V. Cumulative Effects Another non-aflatoxin-producing strain of *Aspergillus flavus* , AF36, is registered, but not for use on corn. Cumulative effects of these strains are not expected to exceed the risk cup for the registered *Aspergillus flavus* strains, AF36 and NRRL 21882. VI. Determination of Safety for U.S. Population, Infants and Children Based on the previously evaluated data, it is not necessary to use a safety factor to determine safety to children June 30, 2004, (69 FR 39341). VII. Other Considerations A. Endocrine Disruptors See **Federal Register** , June 30, 2004, (69 FR 39341). B. Analytical Method See **Federal Register** , June 30, 2004, (69 FR 39341). C. Codex Maximum Residue Level There is no Codex Maximum Residue Level

(MRL)for residues of *Aspergillus flavus* NRRL 21882 on corn. VIII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). IX. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 4, 2007. Janet L. Andersen, Director, Biopesticides and Pollution Prevention 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 180.1254 is amended by designating the existing text as paragraph

(a)and by adding paragraph

(b)to read as follows: § 180.1254 Aspergillus flavus NRRL 21882; exemption from requirement of a tolerance.

(a)* * *

(b)*Aspergillus flavus* NRRL 21882 is temporarily exempt from the requirement of a tolerance on corn when used in accordance with the Experimental Use Permit 75624-EUP-2. This temporary exemption from tolerance will expire on May 2, 2009. [FR Doc. E7-9427 Filed 5-15-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0203; FRL-8126-2] Acetochlor; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation revises and separates the tolerances for acetochlor in 180.470 into paragraphs

(a)through

(d)and reassigns many of the current entries from paragraph

(a)to paragraph (d), which applies to tolerances for indirect and inadvertent residues. This regulation also establishes several new tolerances and amends several existing tolerances under paragraph (a). It further establishes several new tolerances under paragraph (d); and amends and revises two tolerances moved to that paragraph. Details of these changes are outlined in Unit II. of this document. The Acetochlor Registration Partnership

(ARP)and Monsanto Company requested these changes as submitted by petitions to EPA pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA). DATES: This regulation is effective May 16, 2007. Objections and requests for hearings must be received on or before July 16, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0203. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* ,or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

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

(703)305-5704; e-mail address: *walters.vickie@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0203 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before July 16, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0203, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Petition for Tolerance In the **Federal Register** of February 7, 2007 (72 FR 5706) (FRL-8111-8, 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 1F6263, 4F4505, 6F4791) by the Acetochlor Registration Partnership

(ARP)and Monsanto Company, 1300 “I” St., NW., Washington, DC 20005, and PP 5F6918 by Monsanto Company, 1300 “I” St., NW., Suite 450 East, Washington, DC 20005. The petitions requested that 40 CFR 180.470(a) be amended by establishing tolerances for residues of the herbicide, acetochlor [2-chloro-2-methyl-6-ethyl- *N* -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline

(EMA)moiety and the hydroxyethyl methyl-aniline

(HEMA)moiety, and expressed as acetochlor equivalents in or on the food commodities corn, field, forage at 3.0 ppm (5F4505) corn, pop, grain at 0.05 part per million (ppm); corn, pop, stover at 1.5 ppm (PP 1F6263); corn, sweet, fodder and forage at 1.5 ppm; and corn, sweet, kernels plus cob with husks removed at 0.05 ppm (6F4791); sorghum, forage at 1.0 ppm; sorghum, grain at 0.05 ppm; and sorghum, grain, stover at 1.5 ppm (5F6918). These petitions also requested that 40 CFR 180.470(d) be amended by establishing tolerances for residues of the herbicide, acetochlor (2-chloro-2-methyl-6-ethyl- *N* -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline

(EMA)moiety and the hydroxyethyl methyl-aniline

(HEMA)moiety, and expressed as acetochlor equivalents in or on the food commodities beet, sugar, root and tops/ pea and bean (except soybean) dried and shelled (subgroup 6C)/potato/ and grain, cereal (except rice) (group 15),at 0.05 ppm; grain, grain, cereal (except rice), forage/fodder/straw (group 16) forage at 0.5 ppm; grain, cereal (except rice) forage/fodder/straw (group 16) hay at 2.0 ppm; grain, cereal (except rice) forage/fodder/straw (group 16) stover at 0.1 ppm; grain, cereal (except rice) forage/fodder/straw (group 16), straw at 0.3 ppm (1F6263); non-grass animal feeds (group 18) forage at 1.3 ppm; and non-grass animal feeds (group 18) hay at 3.5ppm (6F4791). That notice referenced a summary of the petitions prepared by Acetochlor Registration Partnership and Monsanto Company, the registrants, which have been placed in the public docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. Based upon review of the data supporting the petitions EPA is reassigning the entries for soybean, forage at 0.7 ppm; soybean, grain at 0.1 ppm; soybean, hay at1.0 ppm; wheat, forage at 0.5 ppm; wheat, grain at 0.02 ppm; and wheat, straw at 0.1 ppm; from 180.470(a) to 180.470(d) and establishing a tolerance for wheat, hay at 2.0 ppm under 40.CFR 180.470(d). The terminology for soybean, grain is being updated to read soybean, seed to conform to Agency procedures. Additionally, EPA is increasing the tolerance for corn, field, forage to 3.0 from 1.0 ppm. This tolerance will be listed in 180.470(a). Based upon review of the data submitted and Agency procedures concerning commodity names, the Agency is correcting the terminology for pending crops under 40 CFR 180.470(a) as follows: corn, field, forage at 3.0 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.05 ppm; corn, sweet, forage at 1.5 ppm; and sorghum, grain, grain at 0.05 ppm. The Agency is also correcting the tolerance levels and terminology for pending crops under 40 CFR 180.470(a) as follows: corn, sweet, stover at 1.0 ppm; sorghum, grain, forage at 1.6 ppm; sorghum, grain, grain at 0.05 ppm; and sorghum, grain, stover at 1.7 ppm. The above listings for corn, field, forage; sorghum, grain, forage; sorghum, grain, grain; and sorghum, grain, stover; replace the current listings for corn, field forage; sorghum, forage; sorghum, grain; and sorghum, grain, stover. The Agency also determined that the tolerance expression and correct terminology for the pending crops under 40 CFR 180.470(d) should be written as follows: Tolerances are also established for indirect or inadvertent residues of acetochlor (2-chloro-2'-methyl-6-ethyl- *N* -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline

(EMA)moiety and the hydroxyethyl methyl aniline

(HEMA)moiety, to be analyzed as acetochlor and expressed as acetochlor equivalents, in or on the following raw agricultural commodities when present therein as a result of application of acetochlor to growing crops listed in paragraph

(a)of this section: Animal feed, nongrass, group 18, forage at 1.3 ppm; animal feed, nongrass, group 18, hay at 3.5 ppm; beet, sugar, root at 0.05 ppm; beet, sugar, tops at 0.05 ppm; grain, cereal, group 15 except for corn, grain sorghum, rice and wheat, grain at 0.05 ppm; grain, cereal, forage, fodder and straw, group 16 except for corn, grain sorghum, rice and wheat, forage at 0.5 ppm; grain, cereal, forage, fodder and straw, group 16,except corn, grain sorghum, rice and wheat, hay at 2.0 ppm; grain, cereal, forage, fodder and straw, Group 16, except corn, grain sorghum, rice and wheat, stover at 0.1 ppm; grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, straw at 0.3 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.05 ppm; potato at 0.05; sunflower, seed at 0.05 ppm and wheat, hay at 2.0 ppm. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to FFDCA by the Food Quality Protection Act

(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances and amendments for tolerances for residues of acetochlor (2-chloro-2'-methyl-6-ethyl- *N* -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline

(EMA)moiety and the hydroxyethyl methyl aniline

(HEMA)moiety, to be analyzed as acetochlor and expressed as acetochlor equivalents. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by acetochlor as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* . The referenced document is entitled “Acetochlor-RED Phase 2 Revised HED Chapter of the TRED” and is available in the docket (EPA-HQ-OPP-2005-0227 identified as document 0004. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern

(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors

(UF)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose

(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure

(MOE)called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for acetochlor used for human risk assessment can be found at *www.regulations.gov* in document Acetochlor: Human Health Risk Assessment to Support the Proposed Uses on Sorghum and Sweet Corn and Rotational Crops of Nongrass Animal Feeds (Group 18), Sugar Beets, Dried Shelled Beans and Peas (Subgroup 6C), Sunflowers, Potatoes Cereal Grains (Group 15), and Forage, Fodder and Straw of Cereal Grains (Group 16) on page 11 in Docket ID EPA-HQ-OPP-2006-0203. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to acetochlor, EPA considered exposure under the petitioned-for tolerances as well as all existing acetochlor tolerances in (40 CFR 180.470). EPA assessed dietary exposures from acetochlor in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances or for which tolerances are proposed, were treated and contain tolerance-level residues. Experimentally derived processing factors were used for cereal grain commodities. Default values were used for all other processed commodities. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998; Nationwide CSFII. As to residue levels in food, EPA chronic dietary analysis included anticipated residues from field trial data and assumed that all crop were treated. Experimentally derived processing factors were used for cereal grain commodities. Default values were used for all other processed commodities. iii. *Cancer* . Previously, EPA has treated acetochlor as a non-threshold carcinogen and conducted a linear low-dose quantitative cancer risk assessment in evaluating its safety. The determination that a quantitative linear low-dose cancer assessment was appropriate was based on findings that acetochlor caused mouse lung tumors and histiocytic sarcomas in female mice. The Agency has reexamined the data and concluded they do not support use of a quantitative linear low-dose cancer assessment. The Agency determined that the relationship of the mouse lung tumors to treatment was equivocal, due to some inconsistencies in dose-response between the two available mouse studies, the relatively frequent occurrence of the tumor in older mice and the lack of evidence of direct genotoxicity of acetochlor. Further the Agency found that the increase in the histiocytic sarcomas in female mice in one study was also equivocal. EPA concludes that this equivocal evidence of cancer shows no greater than a negligible risk of cancer. Nonetheless, acetochlor has been associated with nasal tumors in the rats and these tumors remain as a tumor of concern for human exposure to acetochlor. Because, however, the nasal tumors have been found to be a threshold effect, EPA has not used quantitative linear low-dose cancer assessment in assessing this cancer risk. Rather, EPA has relied on the chronic risk assessment because the chronic Reference Dose (cRfD), which is based on a NOAEL of 2 milligrams/kilograms/day (mg/kg/day), is considered to be protective of nasal tumors for which a point of departure of 10 mg/kg/day was identified. EPA has used the same exposure assumptions in assessing cancer risk as in assessing other chronic risks. iv. *Anticipated residue and percent crop treated

(PCT)information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) of FFDCA require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance. 2. *Dietary exposure from drinking water* . The drinking water values used in the dietary risk assessments were based on information provided by the Acetochlor Registration Partner ship water monitoring program to support the current use on field corn. The Agency has determined that the new uses of acetochlor are not likely to result in concentrations exceeding those seen in the field corn monitoring data; therefore this data can be used to estimate drinking water concentrations resulting from the new uses on sweet corn and sorghum. In the monitoring data, exposure to acetochlor parent was significantly higher in the surface water monitoring sites than the ground water monitoring sites; therefore, the concentration used in the acute dietary assessment was from a surface water monitoring site that produced the highest concentration of 0.01821 ppm. The drinking water value used in the chronic dietary risk assessment was from a surface water monitoring site that produced the highest time-weighted annualized mean

(TWAM)concentration for a single year of 0.00143 ppm. 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). Acetochlor is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a 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.” Acetochlor is a member of the chloroacetanilide cumulative assessment group

(CAG)which includes alachlor and butachlor. The Agency previously conducted a cumulative risk assessment for the CAG based on a common mode of action for the production of tumors of the nasal olfactory epithelium in rats. Butachlor was determined to be part of the CAG, however, there are currently no U.S. registrations for the chemical; therefore, it was excluded from the cumulative risk assessment. This risk assessment is fully discussed in the document: *Cumulative Risks from Chloroacetanilide Pesticides* dated March 6, 2006 identified as document EPA-HQ-OPP-2005-0050-0061 which is available on the internet at *http://www.regulaions.gov* in docket number EPA-HQ-OPP-2005-0050. Based on that cumulative risk assessment (CRA), the Agency concluded that the cumulative risks from alachlor and acetochlor did not exceed the Agency's level of concern since cumulative MOEs were above 13,000 for all populations compared to a cumulative level of concern of 100. For this risk assessment the Agency believes that the cumulative risk from these new uses in addition to the current existing uses of acetochlor and alachlor will not exceed The Agency's level of concern. Individual risk assessments were conducted based on a point of departure of 10 mg/kg/day for nasal tumors. Anticipated residues based on field trial data and 100% crop treated was assumed for all existing and new uses for acetochlor. The individual acetochlor assessment from food resulted in MOEs raging from 49,000 for children 1-2 years old and children 3-5 years old to 179,000 for adults 50+. The addition of water to the assessment using surrogate data from the corn monitoring studies, resulted in MOEs ranging from 40,000 for children 1-2 years old to 116,000 for adults 50+. The MOEs for the General U.S. population were 111,000 from food and 83,000 from both food and water. As noted in the March, 2006 cumulative risk assessment for the chloroacetanilide chemicals, alachlor is the index chemical and acetochlor is included in the assessment with a relative potency of 1/20th of alachlor. Further, as noted in the cumulative risk assessment, acetochlor commodities were not considered to be risk drivers in the chloroacetanilide CRA; therefore given the individual MOEs for acetochlor, it is unlikely that the addition of the new uses for acetochlor will cause an unacceptable cumulative risk when considered with the existing alachlor and acetochlor uses. D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . Concern for prenatal and postnatal susceptibility is low for acetochlor since toxicity to offspring was observed only at maternal toxic doses in developmental toxicity studies in the rat and rabbit and in three multi-generation reproductive toxicity studies in the rat. In addition, clear NOAELS were established in all of these three studies. 3. *Conclusion* . A 10X FQPA safety factor was applied to the acute dietary risk in the form of a database uncertainty factor to account for the lack of a developmental neurotoxicity study. The following findings support this determination. i. The toxicity database for acetochlor is not complete at this time. A developmental neurotoxicity study is required based on neurological observations, primarily in the dog or an alternative test which addresses the sensitivity of the dog to neurological effects. In addition, submission of positive control studies for validation of the laboratory methodology used in the acute and subchronic rat oral neurotoxicity screening studies is required as confirmatory data and to upgrade those studies to acceptable. ii. Evidence of neurotoxicity from exposure to acetochlor was observed in several studies. Salvation and other clinical signs (anogential staining, diarrhea) were reported in some studies in both the rat (two developmental studies) and the dog (subchronic and chronic oral). The dog appears to be more sensitive than the rat or mouse to effects on the nervous system, in that salivation occurred at lower dose levels and frank neuropathology of the brain was observed in one study. In the 1-year oral toxicity study in the dog pronounced neurological signs (ataxia, abnormal head movements, tremor, depressed righting, hoping and flexor reflexes, exaggerated tonic neck reflex and stiffness and rigidity of the hindlimbs) were observed at the high dose and were associated with degenerative lesions of the cerebellum. Other evidence of neurotoxicity is discussed on page 46 of the document entitled “Acetochlor-RED Phase 2 Revised HED Chapter of the TRED” which is available on the internet at *http://www.regulaions.gov* in the docket identified as EPA-HQ-OPP-2005-0227 document 0004. iii. The acute dietary endpoint of concern for the general population including females 13-49 years of age, was derived from an acute oral neurotoxicity screening study in rats (NOAEL of 150 mg/kg/day based on decreased motor activity in females. Given the likely dosing in the developmental neurotoxicity study, it is possible that this study could lower the acute RfD by a factor of 10. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X for the chronic dietary risk. That decision is based on the following findings. • The toxicity database for acetochlor is complete other than the lack of a developmental neurotoxicity study. • Given likely dosing in the developmental neurotoxicity study, it is unlikely that this study would lower the cRFD. The chronic dietary endpoint of concern for all populations was derived from the chronic oral toxicity study in dogs with a NOAEL of 2 mg/kg/day based on the increased salivation and histopathology in testes, kidney and liver at 10 mg/kg/day. The cRFD of 2.0 mg/kg/day is less than the NOAELs in the reproductive study of 21 mg/kg/day. A developmental neurotoxicity study will likely be conducted at dose levels similar to those of the 2-generation rat reproduction study. No evidence of neuropathology or overt neurobehavioral effects were observed in the 2-generation reproductive study with rats. • There is no evidence that acetochlor results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. The FQPA safety factor was reduces to 1X. • There are no residual uncertainties identified in the chronic exposure database. The chronic dietary food exposure assessment was based on the assumption of all crops treated and anticipated residues from acceptable field trial data for all commodities. For chronic dietary food exposure assessments, experimentally derived processing factors were used for cereal grain commodities and default processing factors were used for all other processed commodities. The drinking water values used in the dietary risk assessments were based on information provided by the Acetochlor Registration Partnership water monitoring program to support the current use on field corn. These assessments will not underestimate the exposure and risks posed by acetochlor. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to acetochlor will occupy <1% of the aPAD at the 95th percentile for the U.S. population and 2.6% of the aPAD at the 95th percentile for all infants, the population subgroup receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to acetochlor from food and water will utilize <1% of the cPAD for the U.S. population and 1.2 % of the cPAD for children 1-2 years old, the population subgroup receiving the greatest exposure. There are no residential uses for acetochlor that result in chronic residential exposure to acetochlor. 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). Acetochlor is not registered for use on any sites that would result in residential exposure. Therefore, an aggregate risk assessment for this duration is not appropriate. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acetochlor is not registered for use on any sites that would result in residential exposure. Therefore, an aggregate risk assessment for this duration is not appropriate. 5. *Aggregate cancer risk for U.S. population* . As explained above, in Unit III.C.iii., the cRfD is considered to be protective of any cancer risk posed by acetochlor and as discussed in Unit E2, EPA has found that chronic acetochlor exposure does not exceed the cRfD; therefore, aggregate cancer risks are not of concern. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to acetochlor residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate high performance liquid chromatography with oxidative coulometric electrochemical detector (HPLC/OCED) method is available for enforcing new tolerances for acetochlor and its metabolites in sweet corn, sorghum, and rotational crops. This method is listed as Method I for plants in PAM Vol. II. B. International Residue Limits There are no Codex Maximum Residue Levels established for acetochlor on agricultural commodities. V. Conclusion Therefore, tolerances are established for residues of acetochlor (2-chloro-2'-methyl-6-ethyl- *N* -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline

(EMA)moiety and the hydroxyethyl methyl aniline

(HEMA)moiety to be analyzed as acetochlor, and expressed as acetochlor equivalents as discussed in Unit II. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 8, 2007. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.470 is revised to read as follows: § 180.470 Acetochlor; tolerances for residues.

(a)*General* . Tolerances are established for residues of acetochlor; 2-chloro-2'-methyl-6-ethyl- *N* -ethoxymethylacetanilide, and its metabolites containing the ethyl methyl aniline

(EMA)moiety and the hydroxyethyl methyl aniline

(HEMA)moiety, to be analyzed as acetochlor and expressed as acetochlor equivalents, in or on the following raw agricultural commodities. Commodity Parts per million Corn, field, forage 3.0 Corn, field, grain 0.05 Corn, field, stover 1.5 Corn, pop, grain 0.05 Corn, pop, stover 1.5 Corn, sweet, forage 1.5 Corn, sweet, kernels plus cob with husks removed 0.05 Corn, sweet, stover 1.0 Sorghum, grain, forage 1.6 Sorghum, grain, grain 0.05 Sorghum, grain, stover 1.7

(b)*Section 18 emergency exemptions* . [Reserved].

(c)*Tolerances with regional registrations* . [Reserved].

(d)*Indirect or inadvertent residues* . Tolerances are established for indirect or inadvertent residues of acetochlor; 2-chloro-2'-methyl-6-ethyl- *N* -ethoxymethylacetanilide, and its metabolites containing the ethyl methyl aniline

(EMA)moiety and the hydroxyethyl methyl aniline

(HEMA)moiety, to be analyzed as acetochlor and expressed as acetochlor equivalents, in or on the following raw agricultural commodities when present therein as a result of application of acetochlor to the growing crops in paragraph

(a)of this section: Commodity Parts per million Animal feed, nongrass, group 18, forage 1.3 Animal feed, nongrass, group 18, hay 3.5 Beet, sugar, root 0.05 Beet, sugar, tops 0.05 Grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, forage 0.5 Grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, hay 2.0 Grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, stover 0.1 Grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, straw 0.3 Grain, cereal, group 15, except corn, grain sorghum, rice, and wheat, grain 0.05 Pea and bean, dried shelled, except soybean, subgroup 6C 0.05 Potato 0.05 Soybean, forage 0.7 Soybean, hay 1.0 Soybean, seed 0.1 Sunflower, seed 0.05 Wheat, forage 0.5 Wheat, grain 0.02 Wheat, hay 2.0 Wheat, straw 0.1 [FR Doc. E7-9430 Filed 5-15-07; 8:45 am] BILLING CODE 6560-50-S 72 94 Wednesday, May 16, 2007 Proposed Rules DEPARTMENT OF AGRICULTURE Rural Housing Service Rural Business-Cooperative Service Rural Utilities Service Farm Service Agency 7 CFR Part 1924 RIN 0575-AC65 Thermal Standards AGENCY: Rural Housing Service, Rural Business-Cooperative Service, Rural Utilities Service, Farm Service Agency, USDA. ACTION: Proposed rule. SUMMARY: The Rural Housing Service (Agency) is proposing to amend its regulations to be consistent with other federal agencies. The current thermal standards for existing single family housing can impose an unnecessary financial burden on the borrower. Removing the thermal standards for existing single family housing will provide consistency with HUD existing single family housing thermal standards. This change will not affect the thermal standards for new construction; such requirements are generally prescribed by adopted building and model energy codes. Construction materials and building techniques have improved tremendously during the last thirty years, creating many alternatives to achieve thermally efficient homes. Removing the Agency's imposed thermal standards for existing single family housing will give a borrower the opportunity to allocate money towards other improvements which may result in higher cost savings. The rule will not result in any increase in costs or prices to consumers; non-profit organizations; businesses; Federal, State, or local government agencies; or geographic regions. DATES: Written or e-mail comments must be received on or before July 16, 2007. ADDRESSES: You may submit comments on this rule by any of the following methods: • *Federal eRulemaking Portal:* *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Mail:* Submit written comments via the U.S. Postal Service to the Branch Chief, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, STOP 0742, 1400 Independence Avenue, SW., Washington, DC 20250-0742. • *Hand Delivery/Courier:* Submit written comments via Federal Express Mail or another mail courier service requiring a street address to the Branch Chief, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, 300 7th Street, SW., 7th Floor, Suite 701, Washington, DC 20024. All written comments will be available for public inspection during regular work hours at the 300 7th Street, SW., address listed above. FOR FURTHER INFORMATION CONTACT: Michel Mitias, Technical Support Branch, Program Support Staff, Rural Housing Service, U.S. Department of Agriculture, STOP 0761, 1400 Independence Avenue SW., Washington, DC 20250-0761; Telephone: 202-720-9653; FAX: 202-690-4335; E-mail: *michel.mitias@wdc.usda.gov.* SUPPLEMENTARY INFORMATION: Classification This rule has been determined to be not significant for purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB). Civil Justice Reform In accordance with this rule:

(1)All State and local laws and regulations that are in conflict with this rule will be preempted,

(2)no retroactive effect will be given to this rule, and

(3)administrative proceedings in accordance with 7 CFR part 11 must be exhausted before bringing suit in court challenging action taken under this rule, unless those regulations specifically allow bringing suit at an earlier time. Regulatory Flexibility Act The Administrator of the Agency has determined that this rule will not have a significant economic impact on a substantial number of small entities as defined in the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). New provisions included in this rule will not impact a substantial number of small entities to a greater extent than large entities. Therefore, a regulatory flexibility analysis was not performed. Unfunded Mandates Reform Act This rule contains no Federal mandates (under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995) for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act of 1995. Environmental Impact Statement This document has been reviewed in accordance with 7 CFR part 1940, subpart G, “Environmental Program.” The Agency has determined that this action does not constitute a major Federal action significantly affecting the quality of the human environment, and, in accordance with the National Environmental Policy Act of 1969, Pub. L. 91-190, an Environmental Impact Statement is not required. Programs Affected The programs affected are listed in the Catalog of Federal Domestic Assistance under Number 10.410, Very Low to Moderate Income Housing Loans (Direct and Guaranteed/Insured). Federalism The policies contained in this rule do not have any 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. Nor does this rule impose substantial direct compliance costs on State and local governments. Therefore, consultation with the States is not required. Intergovernmental Review The Agency conducts intergovernmental consultation in the manner delineated in RD Instruction 1940-J, “Intergovernmental Review of Rural Development Programs and Activities,” and in 7 CFR part 3015, subpart V. The Very Low to Moderate Income Housing Loans Program, Number 10.410, is not subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials. An intergovernmental review for this revision is not required or applicable. Paperwork Reduction Act There are no new reporting and recordkeeping requirements associated with this rule. E-Government Act Compliance The Agency is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. (If appropriate—For information pertinent to E-GOV compliance related to this proposed rule, please contact Michel Mitias, 202-720-9653. Background The quality of construction, age, and condition of an existing dwelling financed through the Agency's single family housing programs may have a significant impact on the unit's thermal efficiency. The Agency should consider the thermal performance of a home as part of its overall condition, rather than a separate factor. Newer residences, or older residences currently in average or good condition, generally can be accepted as being representative of their community, and are likely to have average thermal efficiency for the market in which they are located. These homes represent a typical residence in terms of overall design, construction, and appeal in the marketplace, and can be presumed to have reasonable, overall thermal performance. Aging residences, particularly those with significant deficiencies, or those designated as being in only fair condition or less, could represent a higher risk to the borrower and the Agency. Homes with older effective ages or in fair condition may be financed in some circumstances with certain upgrades, but should be thoroughly and carefully inspected to insure the overall soundness of the collateral, including thermal components. These homes may require thermal and insulation upgrades in order to ensure reasonable (average) heating and cooling costs for borrowers. The Agency's existing thermal standards, or similar standard, may serve as a guide for an energy efficient home, however we recognize that incremental improvements to existing homes to reach this standard may not always be cost effective. The Agency should look at homes to be financed based on their overall condition. When a home needs improvement in order to be acceptable for our financing, the focus should be on reducing the effective age by improving the existing overall condition as well as increasing energy efficiency. A combination of Uniform Residential Appraisal Report

(URAR)designations for “quality of construction” and “condition”, as well as “age” and “effective age” may be used to judge the overall condition of a home, and whether additional analysis needs to be undertaken to ensure the dwelling will be reasonably thermally efficient for the market in which it is located. In addition, an on-site inspection by an Agency representative or designee may provide further information on the thermal performance of a home. Hence, the Agency has determined that it is no longer necessary to impose thermal standards for existing single family housing. This change will not be subject to Section 509(a) of the Housing Act of 1949 because it pertains only to existing single family housing. All new single family housing construction must comply with the Minimum Property Standards

(MPS)adopted by the Department of Housing and Urban Development (HUD), as well as national model codes adopted by the applicable jurisdiction, locality, or state. List of Subjects in 7 CFR Part 1924 Agriculture, Construction management, Construction and repair, Energy conservation, Housing, Loan programs—Agriculture, Low and moderate income housing. For the reasons set forth in the preamble, Chapter XVIII, Title 7, of the Code of Federal Regulations is amended as follows: PART 1924—CONSTRUCTION AND REPAIR 1. The authority citation for part 1924 continues to read as follows: Authority: 5 U.S.C. 301; 7 U.S.C. 1989; 42 U.S.C. 1480. Subpart A—Planning and Performing Construction and Other Development 2. Exhibit D of subpart A is amended by: A. Removing the last sentence in paragraph II; B. Removing and reserving paragraph IV B; C. Revising the words “paragraphs IV A and IV B” in paragraph IV C 1 to read “paragraph IV A”; D. Revising the words “paragraphs IV A and B” in paragraph IV C 2 to read “paragraph IV A”; E. Revising the words “paragraphs IV A or IV B” in the first and last sentences of paragraph IV C 2b, and in paragraphs IV C 3 introductory text, IV C 3a and IV C 3b to read “paragraph IV A”; and F. Removing the words “or B” in paragraphs IV C introductory text and IV C 3c. Dated: April 6, 2007. Russell T. Davis, Administrator, Rural Housing Service. [FR Doc. 07-2366 Filed 5-15-07; 8:45 am]

Rules and Regulations. Final rule