Rules and Regulations. Final rule; technical amendment

Agency: Environmental Protection Agency (EPA)
Action: Final rule; technical amendment
Citation: FR Doc. 07-3638 · EPA-HQ-OPP-2006-0913; FRL-8134-3 · 40 CFR 174

Summary

EPA issued a direct final rule in the Federal Register of April 25, 2007 (72 FR 20431), concerning plant-incorporated protectant tolerance exemptions. On May 9, 2007 EPA issued a final rule revising the tolerance exemption for Bacillus thuringeniensis Vip3Aa19 in cotton. This technical amendment is being issued to clarify the status and the wording of the tolerance exemption for Bacillus thuringeniensis Vip3Aa19 in cotton.

Dates

This final rule is effective July 25, 2007.

Supplementary Information

I. General Information A. Does this Action Apply to Me? The Agency included in the final rule a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under the FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using 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 . II. What Does this Correction Do? In a direct final rule published on April 25, 2007, (72 FR 20431)(FRL-7742-2) EPA took action to move existing active and inert ingredient plant-incorporated protectant tolerance exemptions from 40 CFR part 180, Tolerances and Exemptions from Tolerances for Pesticide Chemicals in Food to 40 CFR part 174, Procedures and Requirements for Plant-Incorporated Protectants , subpart W. EPA also made some conforming changes to the text of the individual exemptions that were transferred from part 180 so that they would be consistent with part 174, as well as some minor technical corrections to the wording of certain individual exemptions. Since this action was issued as a direct final rule the changes had a delayed effective date and did not become effective until July 24, 2007. Included in the redesignation and revision of part 174, subpart W was §174.452 which was redesignated as §174.501. In the May 9, 2007 issue of the Federal Register (72 FR 26300), EPA issued a final rule which extended the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a plant-incorporated protectant (PIP) by revising §174.452. The extension of the temporary exemptions was requested in a petition submitted by Syngenta Seeds, Inc. to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The May 9, 2007 final rule eliminated the need to establish a maximum permissible level for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a PIP on cotton. The temporary tolerance exemption expires on May 1, 2008. Section 174.452 as printed in the May 9, 2007 issued of the Federal Register codified the current and correct version of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a PIP on cotton in §174.452. The May 9, 2007 version of §174.452 became effective on May 9, 2007. However, §174.452 was redesignated as §174.501 in the April 25, 2007 issue of the Federal Register . The redesignation and revision becomes effective no earlier than July 24, 2007, if no adverse comment is received. Once the direct final rule becomes effective the revision of §174.452 as published in the May 9, 2007 issue of the Federal Register will be wiped out because §174.452 will no longer exist. With this technical amendment EPA is revising §174.501 to read the same as §174.452 which, as was stated above, will be eliminated once the direct final rule becomes effective. III. Why is this Correction Issued as a Final Rule? Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical correction final without prior proposal and opportunity for comment, because the original issuance of the revised §174.452 was properly executed and the impact of the delayed effective date for the April 25, 2007 final rule removing the content of that section was inadvertent. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B). IV. Do Any of the Statutory and Executive Order Reviews Apply to this Action? No. This final rule does not impose any new requirements. It only implements a technical correction to the Code of Federal Regulations (CFR). As such, this action does not require review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not impose any enforceable duty, contain any unfunded mandate, or impose any significant or unique impact on small governments as described in the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require prior consultation with State, local, and tribal government officials as specified by Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993) and Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19,1998), or special consideration of environmental justice related issues under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). 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 since this action is not subject to notice-and-comment requirements under the Administrative Procedure Act (APA) or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ). EPA's compliance with these statutes and Executive Orders for the May 9, 2007 final rule, which established an extension of the temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Vip3Aa19 protein in cotton when applied or used as a plant-incorporated protectant (PIP), is discussed in the preamble for the final rule (72 FR 26300). V. 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 174 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 17, 2007. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, 40 CFR part 174 is amended as follows: PART 174—[AMENDED] 1. The authority citation for part 174 continues to read as follows: Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371. 2. Section 174.501 is revised to read as follows: §174.501 Bacillus thuringiensis Vip3Aa19 protein in cotton; temporary exemption from the requirement of a tolerance. Residues of Bacillus thuringiensis Vip3Aa19 protein in cotton are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant (PIP) in the food and feed commodities of cotton; vegetative-insecticidal protein in cotton seed, cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin byproducts. This temporary exemption from the requirement of tolerance will permit the use of the food commodities in this section when treated in accordance with the provisions of the experimental use permit (EUP) 67979-EUP-7, which is being issued in accordance with the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the requirement of a tolerance expires and is revoked May 1, 2008. However,if the EUP is revoked, or if any experience with or scientific data on this pesticide indicate that the temporary tolerance exemption is not safe, this temporary exemption from the requirement of a tolerance may be revoked at any time. [FR Doc. E7-14373 Filed 7-24-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0446; FRL-8136-7] Diflubenzuron; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time-limited tolerance for diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline in or on lemon. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on lemon. This regulation establishes a maximum permissible level for combined residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline, in this food commodity. The tolerance expires and is revoked on December 31, 2010. DATES: This regulation is effective July 25, 2007. Objections and requests for hearings must be received on or before September 24, 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-2007-0446. 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 Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are 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: Libby Pemberton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9364; e-mail address: pemberton.libby@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. 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-2007-0446 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 September 24, 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-2007-0446, 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 EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for of the insecticide, diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline, in or on lemon at 0.8 parts per million (ppm). This tolerance expires and is revoked on December 31, 2010. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations (CFR). Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. 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. . . ” Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166. EPA is also revising the tolerance expression in § 180.377(b) to be consistent with the preferable wording as expressed in § 180.377(a)(2). III. Emergency Exemption for Diflubenzuron on Lemon and FFDCA Tolerances In the fall of 2005 and spring of 2006, active infestations of Diaprepes root weevil were detected including one lemon orchard (28 acres) in commercial sites in Long Beach, Newport Beach, Carlsbad, Encintas, and La Jolla, California. The California Department of Food and Agriculture (CDFA) has quarantined these sites and has already initiated eradication treatments using products that impact various life stages of this insect. The emergency use of diflubenzuron is needed to treat the egg stage of the weevil when they are detected in lemon. The overall program involves treatment for larval and adult stages as well. EPA has authorized under FIFRA section 18 the use of diflubenzuron on lemon for control of Diaprepes root weevil in California. After having reviewed the submission, EPA concurs that emergency conditions exist for this State. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of diflubenzuron in or on lemon. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance expires and is revoked on December 31, 2007, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on lemon after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether diflubenzuron meets EPA's registration requirements for use on lemon or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of diflubenzuron by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than California to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for diflubenzuron, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . IV. Aggregate Risk Assessment and Determination of Safety 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 . 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 diflubenzuron and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for combined residues of diflubenzuron in or on lemon at 0.8 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows. A. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm . A summary of the toxicological endpoints for diflubenzuron used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 19, 2002 (67 FR 59006) (FRL-7200-4). B. Exposure Assessment 1. Dietary exposure from food and feed uses . Tolerances for residues of diflubenzuron are established under 40 CFR 180.377. Tolerances listed in 40 CFR 180.377(a)(1) are expressed in terms of diflubenzuron per se . Under this section, tolerances of 0.05-6.0 ppm are established for residues in/on eggs; milk; fat and meat of cattle, goat, hog, horse, poultry, and sheep; poultry meat byproducts; cottonseed; mushroom; grapefruit, orange (sweet); tangerine; soybean hulls; and globe artichoke. Tolerances listed in 40 CFR 180.377(a)(2) are expressed in terms of the combined residues of diflubenzuron and its metabolites 4-chlorophenylurea (CPU) and 4-chloroaniline (PCA). Under this section, tolerances of 0.02-55.0 pm are established for residues in/on rice grain and straw; barley grain, straw, and hay; oat, forage, grain, hay, and straw; wheat forage, grain, hay, and straw; grain aspirated fractions; brassica, leafy greens, subgroup 5B; grass, forage, fodder, and hay, group 17; tree nuts (group 14); peanut, peanut hay and refined oil; pistachios; fruit, stone (group 12) except cherry; meat byproducts of cattle, goat, hog, horse, and sheep; pear; pepper; pummelo; turnip greens; and almond hulls. Time-limited tolerances listed in 40 CFR 180.377(b) are expressed in terms of the combined residues of diflubenzuron and its metabolites CPU and PCA, expressed as the parent diflubenzuron, in connection with use of the pesticide under Section 18 Emergency Exemptions granted by EPA. Risk assessments were conducted by EPA to assess dietary exposures from diflubenzuron in food as follows: i. Acute exposure . Acute dietary 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. The diflubenzuron toxicology studies indicated no possibility of such an effect for either the general U.S. population (including infants and children) or the females 13-50 years old population subgroup for diflubenzuron; therefore, an acute dietary exposure analysis was not performed. ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM-FCID TM ) analysis evaluated the individual food consumption as reported by respondents in the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A chronic dietary-exposure assessment was conducted using the established/recommended tolerances for all food commodities, 100% CT information for all proposed and existing uses, and DEEM( TM ) Version 7.81 default processing factors for some processed commodities. iii. Cancer . The Agency has classified diflubenzuron as “Group E,” evidence of non-carcinogenicity for humans, based on lack of evidence of carcinogenicity in rats and mice. There are also two metabolites of diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study. Therefore, EPA classified PCA as a “Group B2” probable human carcinogen. The Agency determined for those commodities that contained PCA and CPU, the Q1* of PCA should be used to calculate the cancer risk from the sum of these two metabolites. Based on the submitted metabolism studies, there are two possible sources for dietary exposure to PCA and CPU: Residues in mushrooms and residues in milk and liver. Because human exposure to PCA and CPU will not be affected by the proposed new uses, and EPA has previously concluded that exposure to these compounds is safe, therefore, the cancer dietary risk from PCA and CPU will not be addressed in this document. For a detailed discussion on the exposure and risks to PCA and CPU, please refer to the September, 2002 Federal Register document titled Diflubenzuron; Pesticide Tolerances (September 19, 2002, FR 67 59006); http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm . 2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to assess dietary exposure to diflubenzuron in drinking water based on measured drinking water concentrations. 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 diflubenzuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppfed1/models/water/index.htm . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentrations in Ground Water (SCI-GROW) models, the estimated environmental concentrations (EECs) of diflubenzuron and the major degradate CPU for chronic exposures are estimated to be 2.76 parts per billion (ppb) for surface water and 0.208 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM , Version 2.03). For chronic dietary risk assessment, the annual average concentration of 2.76 ppb was used to represent the drinking water contribution to chronic dietary exposure for diflubenzuron. 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). Although there are no registered homeowner uses, there are registered uses for professional applications to outdoor residential and recreational areas to control mosquitoes, moths, and other insects. In addition, certain residential use sites will be treated in association with this emergency exemption for the control of the Diaprepes root weevil. However, EPA considers the potential for post-application residential exposure to be low. Further, diflubenzuron has a low dermal absorption rate (0.5%) and will be only applied to the tree canopy. 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 diflubenzuron and any other substances and diflubenzuron 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 diflubenzuron 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 OPP 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/ . C. 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 database 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 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 . Based on the developmental and reproductive toxicity studies, there is no indication of increased susceptibility of rats or rabbits to in utero or postnatal exposure. 3. Conclusion . There is a complete toxicity database for diflubenzuron and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the additional FQPA 10X safety factor to protect infants and children was not needed. This decision was based on the following: i. There is a complete toxicity database for diflubenzuron; ii. There is no indication of increased susceptibility of rats or rabbits to in utero or postnatal exposure; iii. A developmental neurotoxicity study (DNT) with diflubenzuron is not required; iv. Food and drinking water exposure assessments will not underestimate the potential exposure for infants and children; and v. The potential for post-application residential exposures are expected to be limited. Due to the low dermal absorption rate (0.5%) of diflubenzuron, and since it is only applied to the tree canopy to control gypsy moths and mosquitoes, minimal bystander contact is expected. D. Aggregate Risks and Determination of Safety 1. Acute risk . Because there were no toxic effects attributable to a single dose of diflubenzuron, it is not expected to pose an acute risk. 2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to diflubenzuron from food will utilize 12% of the cPAD for the U.S. population, 12% of the cPAD for all infants less than 1 year old and 38% of the cPAD for children 1-2 years old. There are no residential uses for diflubenzuron that result in chronic residential exposure to diflubenzuron. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). The aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 5. Aggregate cancer risk for U.S. population . Based on the available evidence, which included adequate carcinogenicity studies in rats and mice, and battery of negative mutagenicity studies, diflubenzuron has been classified as “Group E,” evidence of non-carcinogenicity for humans, by the Agency. As noted in Unit III.C.1.iii. of this document, the Agency has concluded that human exposure to PCA and CPU (metabolites of diflubenzuron) will not be affected by the proposed new uses. EPA has previously found aggregate exposure to these compounds to be safe. (September 19, 2002, 67 FR 59006); http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm . 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, and to infants and children from aggregate exposure to diflubenzuron residues. V. Other Considerations A. Analytical Enforcement Methodology There are adequate enforcement methods, published in the Pesticide Analytical Manual (PAM, Vol. II), for determining diflubenzuron residues of concern. In addition, a new analytical methodology for plant commodities was successfully validated by an independent laboratory as well as by Agency chemists at the Analytical Chemistry Branch (ACB)/Biological and Economics Analysis Division (BEAD) in conjunction with an approved rice petition (PP 8F4925). The new methods were forwarded to the Food and Drug Administration (FDA) for publication in PAM Vol. II as Roman Numeral Methods. These methods can separately determine residues of diflubenzuron by gas chromatography/electron-capture detection (GC/ECD), CPU by GC/ECD, and PCA by GC/mass spectrometry (MS). B. International Residue Limits The Codex Alimentarius has established maximum residue limits (MRL), expressed in terms of diflubenzuron per se , for many commodities including: Apple (5 ppm), citrus fruits (0.5 ppm), edible offal (mammalian) (0.1 ppm), eggs (0.05 ppm), meat (from mammals other than marine mammals) (0.1 ppm), milks (0.02 ppm), mushrooms (0.3 ppm), pear (5 ppm), pome fruits (5 ppm), poultry meat (0.05 ppm), rice (0.01 ppm), and rice straw and fodder (dry) (0.7 ppm). As the U.S. residue definition includes CPU and PCA, compatibility is not possible with the proposed tolerance. VI. Conclusion Therefore, the tolerance is established for of the insecticide diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6- difluorobenzamide and its metabolites 4-chlorophenylurea and 4-chloroaniline in or on lemon at 0.8 ppm. VII. 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). VIII. 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: July 6, 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 180.377, paragraph (b) is amended by: i. Revising the introductory text and ii. Alphabetically adding the commodity “Lemon” to the table to read as follows: §180.377 Diflubenzuron; tolerances for residues. (b) Section 18 emergency exemptions . Time-limited tolerances are established for of the insecticide diflubenzuron, (N-[[(4-chlorophenyl)amino]carbonyl]-2,6- difluorobenzamide and its metabolites 4-chlorophenylurea and 4-chloroaniline, in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. The tolerances are specified in the following table, and will expire and are revoked on the dates specified. Commodity Parts per million Expiration/revocation date * * * * * Lemon 0.8 12/31/2010 * * * * * [FR Doc. E7-14161 Filed 7-24-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0076; FRL-8137-7] Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for combined residues or residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) in or on fish; fish, shellfish, mollusc; and fish, shellfish, crustacean. Dow AgroSciences LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 25, 2007. Objections and requests for hearings must be received on or before September 24, 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-2006-0076. 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: 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-2006-0076 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 September 24, 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-2006-0076, by one of the following methods: • Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments. • Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805. II. Petition for Tolerance In the Federal Register of April 14, 2006 (72 FR Page 19507) (FRL-8063-4), 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 petition (PP 5F7012) by Dow AgroSciences LLC, Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.605 be amended by establishing an exemption from tolerance for residues of the herbicide penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide, in or on fish and shellfish resulting from its use as an aquatic herbicide. That notice referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available to the public in the docket, http://www.regulations.gov . Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV. below. The Registrant modified their submission and requested tolerances be established. The reason for these changes is explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996. Consistent with section 408(b)(2)(D), of the FFDCA 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 residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) on fish, shellfish, mollusc; fish; and shellfish, crustacean at 0.02, 0.01, and 0.01 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of September 24, 2004 (EPA-HQ-OPP-2004-0286), (FRL-7678-6). 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) used for human risk assessment can be found at www.regulations.gov in document “Penoxsulam. Human Health Risk Assessment for Proposed Uses on Fish and Shellfish. PC Code: 119031, Petition No: 5F7012, DP Num: 325461.” at page 42 in Docket ID EPA-HQ-OPP-2006-0076. C. Exposure Assessment 1. Dietary exposure from food and feed uses . In evaluating dietary exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide, EPA considered exposure under the petitioned-for tolerances as well as all existing penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) tolerances in (40 CFR 180.605). EPA assessed dietary exposures from penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide; 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 . Penoxsulam was classified as “Suggestive Evidence of Carcinogenic Potential.” There is some cancer concern, but the data are judged not sufficient for a stronger conclusion or a quantitative cancer risk assessment (see Unit III.E.5). iv. Anticipated residue and percent crop treated (PCT) information . EPA assumed tolerance level residues and 100% of the crop is treated. 2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide). 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 FQPA Index Reservoir Screening Tool and Screening Concentrations in Groundwater models, the estimated environmental concentrations (EECs) of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) for acute exposures are estimated to be 150 parts per billion (ppb) for surface water and 150 ppb for ground water. The EECs for chronic exposures are estimated to be 150 ppb for surface water and 150 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 150 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 150 ppb was used to access the contribution to drinking water. 3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) is currently registered for the following residential non-dietary sites: Turf/lawn. EPA assessed residential exposure using the following assumptions: • 1,000 ft 2 per day by low pressure hand wand or back pack sprayer for spot treatment of lawns • 0.5 acres per day by push-type granular spreader for broadcast treatment of lawns • 0.06 lb active ingredient (ai) per acre for broadcast treatment • 0.0014 to 0.0016 lbs per 1,000 ft 2 for spot treatment 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) and any other substances and penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) 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 penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) 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 . Based on the results of the submitted toxicology studies, EPA concluded that no FQPA safety factor is needed (i.e. 1X) since there are no residual uncertainties for prenatal and/or postnatal toxicity. 3. Conclusion . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. There was no toxicologically significant evidence observed of neurotoxicity in either the acute or chronic neurotoxicity study. ii. No definitive quantitative or qualitative susceptibility was observed in either of the developmental rat or rabbit studies. iii. Significant dose-related effects in the 2-generation reproduction study were limited to the delay in preputial separation. No other endpoints of reproductive toxicity or offspring growth and survival were affected by treatment. iv. The chronic dietary food exposure assessment utilizes proposed tolerance level residues and 100% crop treated for all commodities. By using these conservative assessments, actual and chronic exposures/risks will not be underestimated. v. The dietary drinking water assessment (Tier 1 estimates) utilizes values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. 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 . There were no treatment-related effects observed in any of the available toxicity studies on penoxsulam that could be considered to have resulted from a single dose of penoxsulam. Therefore no acute exposure is expected. 2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) for the most highly exposed population subgroup from food and water, which utilizes 7% of the cPAD is all infants (<1 year old). 3. Short-term risk and intermediate term risk . For this aquatic use pattern, short- and intermediate-term aggregate exposure takes into account residential exposure, exposure while swimming, plus chronic exposure to food and water (considered being a background exposure level). There is a potential for post application exposure from oral and dermal routes of exposure while swimming in aquatic sites and/or from turf (lawns, golf courses, sports fields, and sod farms) sites treated with penoxsulam. EPA used the SWIMODEL from the Residential Standard Operating Procedures (SOPs) to assess dermal and oral exposure to recreational swimmers. Parameters used in calculating exposure and risk are based on information for competitive swimmers both adult and children (6 years old) in swimming pools which includes an exposure duration of 5 hours. It is anticipated that recreational swimmers in weed infested areas would be less likely to swim with their heads immersed than recreational swimmers in weed-free swimming pools. Since there were no short-term dermal, systemic, neuro or developmental toxicity concerns, the short-term post application assessment addresses only the oral exposure, which results in the same estimated dose for intermediate-term exposure. Thus a short-term aggregate exposure was not required, and the intermediate-term post application exposure assessment combined both oral and dermal exposures, and is also protective for short-term exposure. Short- and intermediate-term postapplication exposures resulted in MOEs> 100 and are therefore not a concern to the Agency. The Agency considers the swimmer dermal and oral MOEs to be over estimates of the actual risk, and therefore swimming exposure assessment was not used in assessing the short- and intermediate-term aggregate risk, and only the exposure resulting from the turf use was assessed. The short-term aggregate risk assessment estimates include both oral and inhalation exposures appropriate to the population of concern. Short-term dermal exposure was not aggregated because no toxicological endpoint was selected. For adults, short-term exposure to penoxsulam can occur as a result of the residential use on turf. Because oral exposure from the residential use as a handler is not expected in adults and no short-term dermal endpoint was selected, only the short-term residential exposure by inhalation is expected in adults. The worst-case MOE residential exposure estimate was aggregated with the chronic dietary (food + water) to provide a worst-case estimate of short-term aggregate risk for U.S. population. As the aggregate MOE is greater than 100, the short-term aggregate risk to adults does exceed EPA's level of concern. For children/toddlers, short-term exposure to penoxsulam can occur as a result of the residential use on turf. Because post-application inhalation exposure is negligible and no short-term dermal endpoint was selected, only short-term residential exposure from oral exposure was included with food and drinking water in the short-term aggregate risk assessment for children/toddlers. The worst-case MOE residential exposure estimate for children was aggregated with the chronic dietary (food + water) to provide a worst-case estimate of short-term aggregate risk for all infants (<1 year old), the child population subgroup with the highest estimated chronic dietary food exposure. As the aggregate MOE is greater than 100, the short-term aggregate risks to children do not exceed EPA's level of concern. Because the amount of residues on turf after 30 days will be negligible, both inhalation and dermal exposure is negligible, and therefore no intermediate-term aggregate exposure assessment from this turf use is required. 4. Aggregate cancer risk for U.S. population . The cancer potential for penoxsulam is classified as “Suggestive Evidence of Carcinogenic Potential.” The classification is based on an increase in large granular lymphocyte leukemia (also called mononuclear cell leukemia (MNCL)) in male Fischer 344 rats. There were increased tumors at all dose levels which exceeded the laboratory historical control data. There is considerable controversy as to the significance and relevance of the tumors for humans, but they cannot be discounted in the overall weight of the evidence. While there is some cancer concern, the data are judged not sufficient for a stronger conclusion or a quantitative cancer risk assessment. 5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, using high performance liquid chromatograph with tandem mass spectroscopy-mass spectroscopy detector (LC/MS/MS), and is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov . B. International Residue Limits There are no CODEX maximum residue limits (MRLs) for fish; fish, shellfish, mollusc; and fish, shellfish, crustacean. C. Response to Comments Comments were received from a private citizen objecting to this product being used in the world, and that the product is too dangerous to be allowed use. A print-out of what appears to be EPA's summary of the toxicological effects and tolerances for rice were included. No other information was provided. EPA has found that there is a reasonable certainty of no harm to humans after considering all pertinent toxicology studies and the exposure levels of humans to penoxsulam. V. Conclusion Therefore, the tolerance is established for residues of penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide, in or on fish, shellfish, mollusc; fish; and shellfish, crustacean at 0.02, 0.01, and 0.01 ppm. The registrant initially requested exemptions from tolerances for fish and shellfish. Based upon review of the data supporting the petition by EPA and subsequent to completion of this risk assessment, the registrant revised their submission and requested tolerances for finfish at 0.01 ppm; shellfish, crustacean at 0.01 ppm; and shellfish, mollusc at 0.02 ppm. For consistency the commodity terms are revised to fish at 0.01 ppm; fish, shellfish, crustacean at 0.01 ppm; and fish, shellfish, mollusc at 0.02 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq. , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 13, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.605 is amended by alphabetically adding the following commodities to the table in paragraph (a) to read as follows: § 180.605 Penoxsulam; tolerances for residues. (a) * * * Commodity Parts per million Fish 0.01 Fish, shellfish, crustacean 0.01 Fish, shellfish, mollusc 0.02 * * * * * [FR Doc. E7-14335 Filed 7-24-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0313; FRL-8137-4] Glufosinate-ammonium; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for combined residues of Glufosinate-ammonium in or on pistachio. Interregional Research Project No. 4 requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 25, 2007. Objections and requests for hearings must be received on or before September 24, 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-2007-0313. 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: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6463; e-mail address: madden.barbara@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-2007-0313 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 September 24, 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-2007-0313, 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 Facility Docket telephone number is (703) 305-5805. II. Petition for Tolerance In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8128-1), 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 7E7196) by Interregional Research Project No. 4, 500 College Road East, Suite 201W, Princeton, NJ 08540-6635. The petition requested that 40 CFR 180.473 be amended by establishing a tolerance for combined residues of the herbicide glufosinate-ammonium and its metabolites expressed as butanoic acid, 2-amino-4-(hydroxymethyl phosphinyl)-, monoammonium salt, 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as glufosinate free acid equivalents, in or on pistachio at 0.1 parts per million (ppm). That notice referenced a summary of the petition prepared by Bayer CropScience LP, 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. 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” an 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 glufosinate-ammonium and its metabolites on pistachio at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. On May 3, 2006 the Agency published a final rule (71 FR 25942, FRL-8060-3) establishing tolerances for combined residues of glufosinate ammonium, butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt, and its metabolite, 3-methylphosphinicopropionic acid in or on barley hay, barley straw, buckwheat fodder, buckwheat forage, oat forage, oat hay, oat straw, rye forage, rye straw, teosinte, triticale, wheat forage, wheat hay and wheat straw at 0.40 ppm. On September 29, 2003, the Agency published a final rule (68 FR 55833, FRL-7327-9) establishing tolerances for combined residues of glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-,monoammonium salt) and its metabolites, 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents, in or on bushberry subgroup, lingonberry, juneberry and salal at 0.15 ppm, cattle, fat at 0.40 ppm, cattle, meat at 0.15 ppm, cattle, meat byproducts at 6.0 ppm, cotton, gin byproducts at 15 ppm, cotton, undelinted seed at 4.0 ppm, egg at 0.15 ppm, goat, fat at 0.40 ppm, goat, meat at 0.15 ppm, goat, meat byproducts at 6.0 ppm, hog, fat at 0.40 ppm, hog, meat at 0.15 ppm, hog, meat byproducts at 6.0 ppm, horse, fat at 0.40 ppm, horse, meat at 0.15 ppm, horse, meat byproducts at 6.0 ppm, milk at 0.15 ppm, poultry, fat at 0.15 ppm, poultry, meat at 0.15 ppm, poultry, meat byproducts at 0.60 ppm, sheep, fat at 0.40 ppm, sheep, meat at 0.15 ppm, and sheep, meat byproducts at 6.0 ppm, rice, grain at 1.0 ppm, rice, straw at 2.0 ppm, and rice, hull at 2.0 ppm. When the Agency conducted the risk assessments in support of the 2003 and 2006 tolerance actions, it assumed that glufosinate-ammonium residues would be present on pistachio at 0.10 ppm, equivalent to the previously established tolerance for the tree nut crop group. Under current regulations, pistachio is not included in the tree nut crop group; however, the residue field trial data required to establish a tolerance on the tree nut crop group may be relied upon to establish a tolerance at the same level on pistachio. Since EPA assumed glufosinate-ammonium residues would be present on pistachio at 0.10 ppm in its most recent risk assessments, establishing the pistachio tolerance will not change the estimated aggregate risks resulting from use of glufosinate ammonium, as discussed in the May 3, 2006 (71 FR 25942, FRL-8060-3) and September 29, 2003 (68 FR 55833, FRL-7327-9) Federal Registers . Refer to these Federal Register documents, available at http://www.regulations.gov , for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the Federal Register documents in support of this action. Based on the risk assessments discussed in the final rules published in the Federal Registers of May 3, 2006 (71 FR 25942, FRL-8060-3) and September 29, 2003, (68 FR 55833, FRL-7327-9), 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 glufosinate-ammonium residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov . B. International Residue Limits There is an established CODEX maximum residue limit (MRL) of 0.1 ppm for residues of glufosinate-ammonium on tree nuts, including pistachios, which is consistent with the U.S. tolerance being established for pistachio. There are no Canadian or Mexican MRLs established for tree nuts or pistachio. V. Conclusion Therefore, the tolerance is established for combined residues of glufosinate-ammonium, (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolites, 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents, in or on pistachio at 0.10 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, 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: July 13, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.473 is amended by alphabetically adding “pistachio” to the table in paragraph (a)(1) to read as follows: § 180.473 Glufosinate-ammonium; tolerances for residues. (a)(1) * * * Commodity Parts per million * * * * * Pistachio 0.10 * * * * * [FR Doc. E7-14170 Filed 7-24-07 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket No. FEMA-7983] Suspension of Community Eligibility AGENCY: Federal Emergency Management Agency, DHS. ACTION: Final rule. SUMMARY: This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. DATES: Effective Dates: The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables. ADDRESSES: If you want to determine whether a particular community was suspended on the suspension date, contact the appropriate FEMA Regional Office. FOR FURTHER INFORMATION CONTACT: David Stearrett, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2953. SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 et seq. ; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register . In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified. Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days. National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared. Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place. Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132. Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988. Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. List of Subjects in 44 CFR Part 64 Flood insurance, Floodplains. Accordingly, 44 CFR part 64 is amended as follows: PART 64—[AMENDED] 1. The authority citation for part 64 continues to read as follows: Authority: 42 U.S.C. 4001 et seq. ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376. § 64.6 [Amended] 2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain Federal assistance no longer available in SFHAs Region IV: Kentucky: Carroll County, Unincorporated Areas 210045 March 26, 1997, Emerg, September 1, 1998, Reg, July 17, 2007, Susp 07/17/2007 07/17/2007. Prestonville, City of, Carroll County 210047 August 2, 1976, Emerg, September 18, 1986, Reg, July 17, 2007, Susp *Do Do. Do = Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension. Dated: July 13, 2007. David I. Maurstad, Assistant Administrator, Mitigation, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E7-14344 Filed 7-24-07; 8:45 am] BILLING CODE 9110-12-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-2747; MB Docket No. 04-427; RM-11127; RM-11239] Radio Broadcasting Services; Ammon and Dubois, ID AGENCY: Federal Communications Commission. ACTION: Final rule; dismissal of petition for reconsideration. SUMMARY: At the parties' request, this document dismisses the petition for reconsideration of the Report and Order in this proceeding. The withdrawal of the petition for reconsideration was filed jointly by Millcreek Broadcasting, LLC, licensee of Stations KNJQ(FM), Manti, Utah, KUUU(FM), South Jordan, Utah, and KUDD(FM), Roy, Utah; Simmons SLC-LS, LLC, licensee of Stations KDWY(FM), Diamondville, Wyoming, KAOX(FM), Kemmerer, Wyoming, and KRAR(FM), Brigham City, Utah; Rocky Mountain Radio Network, Inc., licensee of Station KRMF(FM), Evanston, Wyoming; 3 Point Media—Coalville, LLC, licensee of Station KCUA(FM), Naples, Utah, and College Creek Broadcasting, LLC successful bidder and applicant for four vacant auction allotments. ADDRESSES: Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Victoria M. McCauley, Media Bureau, (202) 418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's Memorandum Opinion and Order, MB Docket No. 04-427 adopted June 20, 2007, and released June 22, 2007. The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC's Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com. The Commission will not send a copy of this Memorandum Opinion and Order in a report to be sent to Congress and the General Accounting Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the petition for reconsideration was dismissed. List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-14368 Filed 7-24-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 90 [ET Docket No. 04-151, WT Docket No. 05-96 and ET Docket No. 02-380; FCC 07-99] Wireless Operations in the 3650-3700 MHz Band AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: This document addresses petitions for reconsideration filed in response to the Commission's Report and Order relating to the 3650-3700 MHz band (3650 MHz band) proceeding. The Commission affirms its previous decisions to create a spectrum environment that will encourage multiple entrants and stimulate the expansion of broadband service to rural and under served areas. To facilitate rapid deployment in the band, the Commissions maintain the previously adopted, non-exclusive licensing scheme. The clarification and modification will facilitate operation of the widest variety of broadband technologies with minimal risk of interference in both the near and long terms. They should further reduce the potential for co-channel interference, provide additional protections to the multiple users in the band under the current licensing regime, and create incentives for the rapid development of broadly compatible contention technologies. DATES: Effective August 24, 2007. FOR FURTHER INFORMATION CONTACT: Jeffrey Dygert, Policy and Rules Division, Office of Engineering and Technology, (202) 418-7300, e-mail: Jeffrey.Dygert@fcc.gov. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Memorandum Opinion and Order , ET Docket No. 04-151, FCC 07-99, adopted May 22, 2007 and released June 17, 2007. The full text of this document is available on the Commission's Internet site at http://www.fcc.gov. It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Best Copy and Printing Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone (202) 488-5300; fax (202) 488-5563; e-mail FCC@BCPIWEB.COM. Summary of the Memorandum Opinion and Order 1. The Memorandum Opinion and Order (MO&O) addresses petitions for reconsideration filed in response to the Commission's Report and Order , 70 FR 24712, May 11, 2005, in prior proceedings relating to the 3650-3700 MHz band (3650 MHz band). The parties petitioning for reconsideration were: BRN Phoenix (BRN); the Enterprise Wireless Alliance (EWA); Intel Corporation, Redline Communications and Alvarion (jointly); Motorola; Redline Communications; the Satellite Industry Association (SIA); the Wireless Communications Association (WCA); and the Wi-Max Forum. 2. The MO&O affirms the Commission's previous decisions to create a spectrum environment that will encourage multiple entrants and stimulate the expansion of broadband service to rural and under served areas. To facilitate rapid deployment in the band, the Commission maintains the previously adopted, non-exclusive licensing scheme. Additionally, the Commission declines to reconsider the requirement that equipment operating in the 3650 MHz band incorporate a contention-based protocol, a technology that permits multiple licensees to share spectrum by ensuring that all licensees receive reasonable opportunities to operate in the band. The Commission clarifies the meaning of contention-based protocol and modifies the rules to limit the operation of equipment using “restricted” contention-based protocols (those that are not capable of avoiding co-frequency interference with all other types of contention-based protocols) to the lower 25 megahertz portion of the 3650 MHz band. The Commission's actions should facilitate operation of the widest variety of broadband technologies with minimal risk of interference in both the near and long terms. The order should further reduce the potential for co-channel interference, provide additional protections to the multiple users in the band under the current licensing regime, and create incentives for the rapid development of broadly compatible contention technologies. 3. Additionally, the Commission denies requests for reconsideration of the previously adopted power limits for fixed and mobile transmissions in the band, concluding that the limits adopted serve to protect against interference both among the band's licensees and with satellite earth stations. Finally, it denies requests to modify the out-of-band emission limits in the rules and declines to revise the rules regarding coordination with satellite licensees operating in the grandfathered exclusion zones around satellite earth stations. Licensing and Use of the Band 4. The Commission adopted a nationwide non-exclusive licensing scheme for the 3650 MHz band in order to create a spectrum environment conducive to the prompt entry by multiple broadband providers in under-served markets—and at low entry costs and with minimal regulatory delay. The Commission concluded that the non-exclusive licensing model, in conjunction with operational and technical safeguards (such as the contention-based protocol and a registration requirement), would obligate licensees to cooperate to avoid harmful interference. The Commission concluded that the licensing rules it adopted would “ensure open access to this spectrum for nominal application fees and allow effective and efficient use of this spectrum in response to market forces.” This, the Commission reasoned, would encourage “rapid deployment of broadband technologies” and advance the “goal of bringing broadband services to all Americans, including consumers living in less densely populated rural and suburban areas. 5. All of the arguments for making modifications to the licensing rules rest on the assumption that non-exclusive licensing will frustrate potential users of the band and its efficient use. The Commission disagrees with these projections. While it acknowledges that the use of a non-exclusive licensing approach must be accompanied with the means to ensure that multiple users can operate successfully in the band, the Commission concludes that it adopted appropriate and practical mechanisms to ensure such an outcome. 6. The Commission declines to alter the band's cooperation requirement to approximate the rights available in an exclusive licensing model. It is not persuaded that the various steps that parties suggest in this regard would more effectively further the public interest and the Commission's goals in this proceeding than the current non-exclusive licensing scheme or that the benefits of these proposed changes overweigh the costs. For example, creating the type of first-in-time rights that parties suggest would give initial market entrants the ability to structure their operations in a manner that could impede subsequent providers' ability to offer viable services and diminish any incentive that such initial market entrants might have in negotiating interference avoidance measures to accommodate new entrants. Requiring the use of third-party frequency coordinators would also add an unnecessary extra layer of process that operators would have to satisfy before deploying their equipment and initiating service. Given the use of contention protocols in the band, the Commission declines to require a separate entity to serve as a gate-keeper for the spectrum. Similarly, performance standards and the attendant reporting obligation would duplicate the discipline that the market will already provide. If an operator is not providing adequate service, other operators will be free to deploy their facilities in the market and begin their own operations. 7. The Commission disagrees that non-exclusive licensing will make the band unusable. The licensing procedures adopted for the band provide no first-in-time right to exclude others from entering a market, as would be necessary to make squatting behavior profitable. To the contrary, the cooperation and contention-based protocol rules both require that licensees take various steps to accommodate (or at least avoid interfering with) the operations of other licensees in their area. Similarly, these requirements should eliminate licensee behavior that could overcrowd the band to the detriment of all users. They will prevent licensees from consuming the full band and crowding out the transmissions of other operators. Licensees that must coordinate their operations with other licensees and deploy equipment that avoids harmful interference will not be able to overwhelm their neighbors. 8. In contrast to an exclusive licensing model in which a licensee may exclude others from a particular license area, the non-exclusive licensing model adopted in the 3650 MHz Order requires a potential entrant to consider that the presence of other licensees will require cooperative use and may, at times, restrict the amount of spectrum and/or time that spectrum is available to any particular licensee. That trade-off, however, does not automatically render the spectrum unusable. Contention-Based Protocol 9. In the 3650 MHz Order, the Commission explained that contention-based protocols, which it required for fixed, base and mobile equipment operating in the band, would “allow multiple users to share the same spectrum by defining the events that must occur when two or more devices attempt to simultaneously access the same channel and establishing rules by which each device is provided a reasonable opportunity to operate.” The Commission's goal in adopting the contention requirement was to speed deployment in the 3650 MHz band by allowing multiple entrants to provide service. It saw the protocol as a means to “ensure efficient and cooperative shared use of the spectrum.” The Commission chose not to require a specific contention-based protocol, leaving it to industry and standards bodies to determine appropriate protocols. The Commission cautioned, though, that equipment would not be certified for use in the band if it appeared “to be designed to preclude others from using this spectrum.” The Commission stated that it would monitor use of the spectrum, and would modify the rules if there appeared to be significant problems in this regard. 10. The Commission concludes that the public interest is best served by retaining the requirement that fixed, base and mobile equipment operating in the band incorporate a contention-based protocol. Given the decision to retain non-exclusive licensing in the 3650 MHz band, the Commission continues to believe that equipment incorporating a contention-based protocol will provide a cost-effective means to enable multiple users to operate on the same frequencies in the band without interfering with one another. With contention-based protocol requirement, operators and their customers will not have to rely on frequency coordination prior to the initiation of service; this will reduce costs and delay. 11. The Commission is not persuaded that the shortcomings that petitioners ascribe to contention protocols will necessarily limit use of the band to short range applications. Competing evidence indicates that contention technology is suitable for many different applications that the 3650 MHz Order envisioned, including long range operations. Long range transmissions typically would be point-to-point using narrow beams. Point-to-point transmissions at the power limits adopted for the band will have a lower potential for interference and allow providers to use this band for backhaul operations, especially in less congested rural areas. The Commission's goal of providing for multiple entrants in the band can best be accomplished if users have the flexibility to choose the technology most appropriate to meet their needs. Accordingly, the Commission denies those petitions for reconsideration that seek elimination of the contention protocol requirement. 12. The Commission clarifies that the 3650 MHz rules provide for certification of a variety of devices that may use different types of protocols or interference avoidance mechanisms that satisfy the contention definition that applies to the 3650 MHz band. The definition of what constitutes a valid contention protocol for the 3650 MHz band is broad enough to encompass different types of contention protocols and interference avoidance mechanisms, thereby promoting innovation and product development. As stated in the 3650 MHz Order , equipment for use in the 3650 MHz band must incorporate a mechanism that allows “multiple users to share the same spectrum * * * and establish[es] rules by which each device is provided a reasonable opportunity to operate.” 13. The record reveals two broad categories of contention-based protocols, both of which appear to the requirements for operation in the 3650 MHz band. Nonetheless, they may not be compatible with each other, and the use of both types could result in co-frequency interference and thus frustrate the Commission's goal of allowing for multiple entrants in the band. Under the Commission's rules, contention-based protocols can be categorized as either “unrestricted” or “restricted.” Unrestricted protocols are broadly compatible and function to prevent interference even with other, dissimilar contention technologies on the market. A listen-before-talk technology like that in Wi-Fi devices is a prime example of an unrestricted contention-based protocol. On the other hand, restricted contention protocols can prevent interference only with other devices incorporating the same protocol. 14. Allowing the use of different protocols in the band will serve the goal of speeding deployment of service, since operators will be able to deploy many different technologies, including those already being developed for use in the 3650 MHz band world-wide. Nonetheless, the potential exists for conflict between certain types of protocols, which could result in interference and/or a denial of access to the band for certain users. To resolve this conflict, the Commission will certify equipment using a restricted contention protocol but will limit the operation of such equipment to the lower 25 megahertz of the 3650 MHz band. On the other hand, equipment using an unrestricted contention protocol will be allowed to operate throughout the 50 megahertz in the 3650 MHz band, since it will be able to detect other transmissions throughout the band and thus avoid co-frequency interference anywhere in the band. The Commission concludes that this approach will ensure efficient use of the spectrum and permit the prompt deployment in this country of equipment that is already being used in this spectrum in other countries around the globe. Permitting a number of different contention based technologies to operate in the band will also provide additional flexibility to licensees to choose the best suitable technology for the type of services they plan to provide. 15. The Commission will implement this approach through the equipment certification process, under which it will examine for compliance with the rules all equipment proposed for use in the 3650 MHz band. It will condition the certification for equipment using a restricted protocol to limit its operation and tuning range to the bottom 25 megahertz of the band. The registration database will include the FCC identification number, reflecting the equipment certification condition restricting the licensee's operating frequency range if the licensee employs equipment using a restricted contention-based protocol. 16. The Commission recognizes that manufacturers, through software upgrades or other means may alter the emission characteristics of previously deployed devices so that they move from the restricted to the unrestricted category. To the extent that this occurs, the manufacturer will be responsible for complying with the Commission's rules regarding the need for new equipment certification before the device will be permitted to tune over the full 50 megahertz of the 3650 MHz band. Further, affected licensees must update their base and fixed station registrations to reflect this change. 17. By contrast, the Commission will not condition the certification for equipment incorporating an unrestricted contention-based protocol, thus allowing such equipment to operate throughout the full 50 MHz of the band. This should create an added incentive for industry groups and manufacturers to speed their development and deployment of such technology. In the long term, this, should improve the quality of service in the 3650 MHz band, furthering the public interest. At the same time, however, permitting restricted contention technologies to operate in the lower 25 MHz of the band will ensure that a wider range of currently available equipment may be immediately deployed in the band. 18. The Commission denies the petitions for reconsideration to the extent that they seek elimination of the requirement that equipment in the 3650 MHz band incorporate a contention-based protocol. 19. The Commission notes the request by BRN Phoenix that the Commission certify its Advanced Antenna System as the (apparently sole) contention-based protocol for use in the 3650 MHz band. The Commission expects that a variety of different contention technologies will qualify for deployment in the band. BRN, like other parties may seek certification for its Advanced Antenna System from the Laboratory Division of the Commission's Office of Engineering and Technology. Emissions Limits 20. In setting the power limits for transmissions in the 3650 MHz band, the Commission balanced numerous competing factors to “serve the public interest and foster the expeditious introduction of new terrestrial services in the 3650 MHz band.” These factors included (1) the importance of interference protection for grandfathered satellite earth stations and federal government radiolocation stations and (2) the need to ensure efficient use of the band by avoiding mutual interference among licensed operators. To this end, the Commission adopted a peak power density of 25 Watts per 25 MHz of bandwidth and no greater than 1 watt per 1 MHz of bandwidth for fixed operations and imposed a limit of 1 Watt per 25 MHz of bandwidth for mobile operations. Fixed and Mobile Power Limits 21. The Commission declines to increase the power limits for either fixed or mobile operations in the 3650 MHz band. In adopting power limits for this band, the Commission balanced the potential for inter-service and intra-service interference with the need to provide for satisfactory service by 3650 MHz devices. At the same time, the Commission was concerned that the combination of power limits and the size of the earth station exclusion zones that it adopted would adequately protect from harmful interference the grandfathered satellite operations and Federal Government radiolocation stations. 22. The Commission concludes that the 3650 MHz Order set the 3650 MHz power limits at an appropriate level. The levels adopted are adequate to support commercially viable services and will allow licensees to operate effectively in the band without unacceptably interfering with each other's operations (provided they deploy equipment incorporating an appropriate contention technology). At the same time, the power limits, combined with the size of the protection zones for grandfathered satellite earth stations, will prevent terrestrial operations in the band from interfering with in-band satellite operations. Advanced Antenna Systems 23. The Commission declines BRN's request to reconsider the limit on power output in the 3650 MHz band. In the 3650 MHz Order, the Commission balanced the public interest factors that BRN raises in its petition. Specifically, it considered the issues surrounding “deployment of advanced antenna systems, including sectorized and adaptive array systems.” It balanced the need for “flexibility for licensees to employ a wide variety of advanced antennas to meet their needs” with the goal of protecting satellite earth stations. In so doing, it concluded that, “to allow flexibility in deployment” of these systems, it would allow such antennas to operate with a slightly higher power output. BRN Phoenix identifies no deficiency in the Commission's decision that would warrant reconsideration. Accordingly, the Commission denies its petition in this regard. FSS Satellite Issues 24. The Commission took several steps to minimize the extent to which terrestrial operations in the 3650 MHz band would affect the operations of satellite operators in both the conventional C-band (3700-4200 MHz) and the extended C-band (3625-3700 MHz). First, the Commission established protection zones with a radius of 150 km around the earth stations of grandfathered Fixed Satellite Service (FSS) operators in the 3650 MHz band. The Commission ruled that licensees in the 3650 MHz band could establish Fixed Service operations within the protection zones only with the consent of the affected FSS operator. For 3650 MHz licensees, the Commission established fixed station operating power limits of 25 Watts and mobile station operating power limits of 1 Watt. Additionally, the Commission sought to avoid out-of-band interference by requiring operators to limit emissions into adjacent bands by a minimum attenuation of 43 + 10 log(P) below the transmit power. Out-of-Band Interference 25. The Satellite Industry Association (SIA) sought reconsideration of the 3650 MHz Order, arguing that the newly authorized terrestrial operations in the 3650 MHz band will create interference in the adjacent 3700-4200 band that, contrary to the public interest, could disrupt C-band satellite operations. The Commission concludes that SIA's analysis contains overly conservative assumptions about path loss attenuation, the necessary C/I protection ratio and the arrival angle of a 3650 MHz signal at a satellite earth station. Each of these assumptions contributes to the overly pessimistic picture that SIA paints in its analysis. When these assumptions are adjusted to reflect more realistic operational scenarios the attenuation requirement in the * 3650 MHz Order * adequately protects operations in adjacent bands. 26. The Commission may, however, require greater suppression of the out-of-band emissions of a 3650 MHz operator in those rare instances when a 3650 MHz transmitter falls near the main beam and in a line of sight of a satellite earth station. Power Limits and LNB Saturation 27. SIA argued that the potential exists for emissions from the 3650 MHz transmitters to saturate the low noise block converters (LNBs) on FSS earth stations operating in the adjacent C-band at 3700-4200 MHz. SIA requests that the Commission reconsider the permissible power level for fixed and base stations, at least in the upper half of the 3650 MHz band (that closest to the C-band) and set it at a level below the 25-watt figure that the prior order adopted. 28. The Commission declines to reconsider the permissible power limits in the 3650 MHz band as SIA requests. A review of the analysis that SIA provides for its argument on LNB saturation reveals that it is based on two very conservative assumptions. The predicted saturation is most pronounced when the arrival angle of the satellite antenna is 5 degrees. At greater arrival angles—as will exist for the great majority of earth stations—the interference projected by SIA's analysis is reduced. The Commission also notes that SIA has again assumed free space assumptions for its propagation analysis. Employing a path loss exponent greater than 2, as was done for the OOB emissions estimate, significantly reduces the potential interference. 29. Given the smaller separation distances necessary to alleviate LNB saturation predicted by a more realistic propagation model, a modest coordination effort should allow satellite earth stations to operate effectively, despite the presence of nearby operations in the 3650 MHz band. The Commission expects 3650 MHz licensees and satellite operators to undertake such coordination where necessary. The registration requirement for fixed and base station operations in the band will facilitate this coordination. In the registration process, licensees in the 3650 MHz band will be required to provide identification and location information for their fixed and base stations, as well as the technical information necessary for interference analysis. 30. The Commission rejects the argument that the authorization of operations in the 3650 MHz band improperly places the burden of avoiding interference on incumbents. It is not Commission policy to protect incumbent licensees against all emissions from adjacent bands; this is particularly true when the emissions are a foreseeable result of prior allocation orders. Installation of appropriate filters on satellite earth stations can adequately address the LNB saturation issue that SIA now raises. Satellite Coordination Requirements 31. Petitioners urge the Commission to impose the guidelines of the Commission's part 101 rules as a framework for the coordination of 3650 MHz operations within the exclusion zones established around grandfathered FSS earth stations. They contend that this would expedite fixed station entry without creating interference risk to the grandfathered FSS earth stations. 32. The Commission declines to adopt the part 101 rules as the sole means of coordination for those 3650 MHz licensees seeking to operate fixed services within the exclusion zones that the Commission established around grandfathered FSS earth stations. The part 101 rules, inter alia, “prescribe the manner in which portions of the radio spectrum may be made available for private * * * microwave operations that require transmitting facilities on land.” In doing so, however, they set out specific coordination procedures and interference protection criteria for covered fixed microwave transmitters. Rather than impose these specific procedures and criteria, the Commission prefers to allow the parties involved to choose for themselves the rules governing their particular negotiations. Ordering Clauses 33. Pursuant to the authority contained in sections 4(i), 302, 303(e), 303(f), and 307 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(c), 303(f), and 307, this Order on Reconsideration is hereby adopted. 34. Pursuant to sections 4(i), 302, 303(e), 303(f), 303(g), 303(r), and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(e), 303(f), 303(g), and 405, that the petitions for reconsideration, filed by Motorola and Redline and seeking clarification regarding the contention-based protocol requirement are granted to the extent discussed in the Memorandum Opinion and Order. 35. Part 90 of the Commission's rules is amended as specified in rule changes, and such rule amendments shall be effective August 24, 2007. 36. Pursuant to sections 4(i), 302, 303(e), 303(f), 303(g), 303(r), and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 302, 303(e), 303(f), 303(g), and 405, that the remainder of the petitions for reconsideration filed by Motorola and Redline, as well as the reconsideration petitions of BRN Phoenix, the Enterprise Wireless Alliance, the Satellite Industry Association, the Wireless Communications Association, the Wi-Max Forum, and the joint petition of Intel, Redline and Alvarion are denied. Report to Congress 37. The Commission will send a copy of the Memorandum Opinion and Order, in a report to be sent to Congress pursuant to the Congressional Review Act. 1 In addition, the Commission will send a copy of the Memorandum Opinion and Order, to Congress and the Government Accountability Office. 1 See 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR part 90 Communications equipment, Reporting and recordkeeping requirements. Federal Communications Commission. Marlene H. Dortch, Secretary. Final Rule For reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 90 to read as follows: PART 90—PRIVATE LAND MOBILE RADIO SERVICES 1. The authority citation for part 90 continues to read as follows: Authority: Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 303(g), 303(r), 332(c)(7). 2. Section 90.7 is amended by revising the definition of “Contention-based protocol” to read as follows. § 90.7 Definitions. Contention-based protocol . A protocol that allows multiple users to share the same spectrum by defining the events that must occur when two or more transmitters attempt to simultaneously access the same channel and establishing rules by which a transmitter provides reasonable opportunities for other transmitters to operate. Such a protocol may consist of procedures for initiating new transmissions, procedures for determining the state of the channel (available or unavailable), and procedures for managing retransmissions in the event of a busy channel. Contention-based protocols shall fall into one of two categories: (1) An unrestricted contention-based protocol is one which can avoid co-frequency interference with devices using all other types of contention-based protocols. (2) A restricted contention-based protocol is one that does not qualify as unrestricted. 3. Section 90.203 is amended by revising paragraph (o) to read as follows: § 90.203 Certification required. (o) Equipment certification for transmitters in the 3650-3700 MHz band . (1) Applications for all transmitters must describe the methodology used to meet the requirement that each transmitter employ a contention based protocol and indicate whether it is capable of avoiding co-frequency interference with devices using all other types of contention-based protocols (see §§ 90.7, 90.1305 and 90.1321 of this part); (2) Applications for mobile transmitters must identify the base stations with which they are designed to communicate and describe how the requirement to positively receive and decode an enabling signal is incorporated (see § 90.1333 of this part); and (3) Applications for systems using advanced antenna technology must provide the algorithm used to reduce the equivalent isotropically radiated power (EIRP) to the maximum allowed in the event of overlapping beams (see § 90.1321 of this part). (4) Applications for fixed transmitters must include a description of the installation instructions and guidelines for RF safety exposure requirements that will be included with the transmitter. (See § 90.1335). 4. Section 90.1319 is revised to read as follows: § 90.1319 Policies governing the use of the 3650-3700 MHz band. (a) Channels in this band are available on a shared basis only and will not be assigned for the exclusive use of any licensee. (b) Any base, fixed, or mobile station operating in the band must employ a contention-based protocol. (c) Equipment incorporating an unrestricted contention-based protocol (i.e. one capable of avoiding co-frequency interference with devices using all other types of contention-based protocols) may operate throughout the 50 megahertz of this frequency band. Equipment incorporating a restricted contention-based protocol (i.e. one that does not qualify as unrestricted) may operate in, and shall only tune over, the lower 25 megahertz of this frequency band. (d) All applicants and licensees shall cooperate in the selection and use of frequencies in the 3650-3700 MHz band in order to minimize the potential for interference and make the most effective use of the authorized facilities. A database identifying the locations of registered stations will be available at http://wireless.fcc.gov/uls . Licensees should examine this database before seeking station authorization, and make every effort to ensure that their fixed and base stations operate at a location, and with technical parameters, that will minimize the potential to cause and receive interference. Licensees of stations suffering or causing harmful interference are expected to cooperate and resolve this problem by mutually satisfactory arrangements. [FR Doc. E7-14211 Filed 7-24-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 070213032-7032-01] RIN 0648-XB66 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Western Regulatory Area of the Gulf of Alaska AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; closure. SUMMARY: NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2007 total allowable catch (TAC) of Pacific ocean perch in the Western Regulatory Area of the GOA. DATES: Effective 1200 hrs, Alaska local time (A.l.t.), July 22, 2007, through 2400 hrs, A.l.t., December 31, 2007. FOR FURTHER INFORMATION CONTACT: Jennifer Hogan, 907-586-7228. SUPPLEMENTARY INFORMATION: NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. The 2007 TAC of Pacific ocean perch in the Western Regulatory Area of the GOA is 4,244 metric tons (mt) as established by the 2007 and 2008 harvest specifications for groundfish of the GOA (72 FR 9676, March 5, 2007). In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2007 TAC of Pacific ocean perch in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 4,194 mt, and is setting aside the remaining 50 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip. Classification This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific ocean perch in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 19, 2007. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment. This action is required by § 679.20 and is exempt from review under Executive Order 12866. Authority: 16 U.S.C. 1801 et seq. Dated: July 19, 2007. Emily Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 07-3638 Filed 7-20-07; 2:05 pm]