Proposed Rules. Notification to the Secretary of Agriculture

Agency: Environmental Protection Agency (EPA)
Action: Notification to the Secretary of Agriculture
Citation: FR Doc. 06-5227 · RIN 2070-AD29 · EPA-HQ-OPP-2004-0404; FRL-8071-5 · 40 CFR 155

Summary

This document notifies the public that the Administrator of EPA has forwarded to the Secretary of Agriculture a draft final rule as required by section 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). As described in the Agency's semi-annual Regulatory Agenda, the draft final rule will establish procedures to implement section 3(g) of FIFRA which provides for periodic review of pesticide registrations. The goal of these regulations, which are required by FIFRA section 3(g), is to review a pesticide's registration every 15 years. The regulations will address the following procedural aspects of the program: establishing pesticide cases for registration review; establishing schedules; assembling information to be considered during the review; deciding on the scope and depth of the review; calling in data under FIFRA section 3(c)(2)(B) that are needed to conduct the review; reviewing data and conducting risk assessments or benefit analyses, as needed; deciding whether a pesticide continues to meet the standard of registration in FIFRA; and public participation in the registration review process. If a pesticide does not meet the FIFRA standard, and cancellation is determined to be needed, the Agency will follow cancellation procedures in section 6 of FIFRA. This program will begin after the completion of tolerance reassessment in 2006 and before the completion of reregistration in 2008. Each pesticide will be reviewed every 15 years to assure that the it continues to meet the FIFRA standard for registration, including compliance with any new legislation, regulations or science policy.

Dates

This regulation is effective June 14, 2006. Objections and requests for hearings must be received on or before August 14, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0303. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805. FOR FURTHER INFORMATION CONTACT: Anne Ball, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204607-0001; telephone number: (703) 308-8717; e-mail address:ball.anne@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 . To access the OPPTS Harmonized Guidelines referenced in this document, go to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0303 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 August 14, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2005-0303, by one of the following methods. • Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments. • * Mail* : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • * Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305-5805. II. Background and Statutory Findings In the Federal Register of January 18, 2006 (71 FR 2932-2933) (FRL-7755-9), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 5G6983) by Montana Microbial Products, 510 East Kent Avenue, Missoula MT 59801. The petition requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Bacillus mycoides isolate J. This notice included a summary of the petition prepared by the petitioner Montana Microbial Products. One comment was received in response to the notice of filing. The commenter objected to an exemption from the requirement of a tolerance. This commenter apparently misunderstood the nature of the product which does not contain a gene-altered substance. EPA concludes that Bacillus mycoides isolate J is ubiquitous in nature and for purposes of this temporary tolerance exemption, EPA has determined that it will be safe when used in agriculture. Section 408(c)(2)(a)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. An Acute Pulmonary Toxicity/Pathogenicity study (OPPTS 885.3150) in rats which were dosed intratracheally with Bacillus mycoides isolate J at 1.1 x 10 8 cfu/animal, was reviewed and found to be supplemental because a clear pattern of clearance from all organs was not demonstrated during the study's 35-day length. The test substance, however, did show a pattern of clearance in some organs. Differential heat treatment of tissue samples had suggested that most of the recovered organisms were spores. No treated animals died nor were there signs in the animals of toxicity or pathogenicity. Given the ubiquitous nature of this spore forming bacterium which is found on plants, in soil, water, air and decomposing plant tissue, along with the lack of mortality of the test animals and the absence of overt signs of toxicity or pathogenicity in the animals during the course of this pulmonary study, issuance of the Experimental Use Permit (EUP) can be justified provided there are instructions for appropriate respiratory protection for the applicators specified on the product label. The Agency has granted the requests for waivers for the studies Primary Eye Irritation ( OPPTS 870.2400) and Primary Dermal Irritation (OPPTS 870.2500). The registrant had provided the following rationales for the requests with which the EPA agrees: 1. The inert ingredient in the Bacillus mycoides isolate J end product is on the EPA inert list 4A as safe for food use. The combination of Bacillus mycoides isolate J spores with this inert would not be expected to exacerbate primary ocular and dermal irritation or infection. 2. Personnel who worked with Bacillus mycoides isolate J for 2 to 7 years showed no eye or dermal exposure effects. 3. Eye or dermal exposure to Bacillus mycoides isolate J will be limited by supervision and protective equipment. If eye or dermal exposure did, however, occur, the spores will rinse out of the eye with water or wash off the skin with soap and water because spores are hydrophilic. 4. Bacillus mycoides isolate J is not recorded as a human pathogen. Due to the ubiquitous presence of Bacillus mycoides isolate J in agricultural soils, there has been long term human exposure to Bacillus mycoides isolate J in crops and to residual Bacillus mycoides isolate J cells or spores in food crops. No toxicity or pathogenicity of Bacillus mycoides isolate J in humans had been reported in numerous searched citations. In connection with the requirement for reporting Hypersensitivity Incidents (OPPTS 885.3400), the Registrant has notified the Agency that no recorded or reported adverse hypersensitivity reaction to Bacillus mycoides isolate J has occurred during the period of 2 years in which the substance has been handled in a laboratory setting. As stated above, a pattern of complete clearance from all organs had not been demonstrated for the acute pulmonary toxicity/pathogenicity study (OPPTS 885.3150).The requests for waivers on the following studies are contingent on demonstrating a pattern of clearance of the test organism in the acute pulmonary toxicity/pathogenicity study, and thus the requests for waivers were not granted. • Acute Oral Toxicity/Pathogenicity (OPPTS 885.3050) • Acute Dermal Toxicity/Pathogenicity (OPPTS 885.3100) • Acute Injection Toxicity/Pathogenicity (OPPTS 885.3200) • Immune Response (OPPTS 885.3550) However, as previously stated in this document, the test substance for the acute pulmonary toxicity/pathogenicity did show a pattern of clearance in some organs. There was no mortality of the test animals, nor were there signs in the animals of toxicity or pathogenicity caused by this ubiquitous spore-forming bacterium. The issuance of the Experimental Use Permit (EUP) can be justified provided there are instructions for appropriate respiratory protection for the applicators specified on the product label. The basis for this conclusion rests not only on the ubiquitous nature of Bacillus mycoides isolate J, the absence of mortality, and of overt adverse reactions in the test animals, but also on the absence of reported or cited incidents of pathogenicity or toxicity in the course of an extensive literature search. Therefore, issuance of the Experimental Use Permit (EUP) can be justified without the requirement for studies based on OPPTS 885.3050, 885.3100, 885.3200 and 885.3550, provided there are instructions for appropriate respiratory protection for the applicators specified on the product label. IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure The proposed EUP is not expected to result in increased dietary exposures of Bacillus mycoides isolate J to the general population. The quantity of Bacillus mycoides isolate J applied to the beet foliage, 7.5 x 10 11 spores/acre per application, is small compared to the natural background levels of Bacillus mycoides isolate J in agricultural soils which is reported to typically occur at about 10 5 spores per gram. Also, the titer of Bacillus mycoides isolate J applied to the foliage declines from 10 6 spores/cm 2 to between 100 and 1,000 spores/cm 2 over a 2-week period. Because the ordinary consumer encounters only the sugar produced from sugar beets, (in which the bacterium is not present), an increased dietary exposure is not foreseen. There is, in addition, minimal to negligible risk that surface water and, thus, drinking water exposure would occur with the proposed EUP testing. The proposed test sites are at least one-half mile from the nearest surface water. When spray drift or accidental application of Bacillus mycoides isolate J over surface water did occur, the concentration of Bacillus mycoides isolate J spores in the water had been found to be very low. For example an acre dose of Bacillus mycoides isolate J, 7.5 x 10 11 spores to 100 square meters of surface water 1 meter deep, would result in a concentration of 750 spores per cc of water as noted in the EPA ecological risk assessment for Bacillus mycoides isolate J which is based on data submitted by the Montana Microbial Products. B. Other Non-Occupational Exposure EPA concludes that dermal or inhalation exposure to the general population as a result of this EUP is not likely to occur, based on information submitted in pesticide tolerance petition 5G6983 indicating that the relevant EUP agricultural sites, which are located in the Red River Valley of North Dakota and Minnesota and in eastern Montana, and which will not exceed 956 acres, are not accessible to individuals other than those conducting this EUP program. V. Cumulative Effects Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common method of toxicity. Because there is no indication of mammalian toxicity or pathogenicity resulting from Bacillus mycoides isolate J, we conclude that there are no cumulative effects for this bacterium. VI. Determination of Safety for U.S Population, Infants and Children 1. U. S. population . The Agency has determined that there is reasonable certainty that no harm will result to the U. S. population from exposure to residues of Bacillus mycoides isolate J in connection with the testing for the proposed EUP program. This determination includes all anticipated dietary exposures and other non-occupational exposures for which there is reliable information. Oral ingestion of the organism is unlikely because consumers will purchase only the sugar produced from the sugar beets. This product is not anticipated to contain any spores or cells derived from the treatment of the foliage of the sugar beets. Data submitted in a pulmonary toxicity/pathogenicity study revealed no signs of overt toxicity or pathogenicity in the test animals. The results of an extensive literature search, which included numerous citations of the test organism, yielded no reports of its pathogenicity for mammals. There will be no access to persons other than participants in the program to the test sites for the EUP. The participants in the EUP program are required to wear appropriate respiratory protection. 2. Infants and children . FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall apply an additional tenfold margin of safety, also referred to as margins of exposure (MOEs), for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different MOE will be safe for infants and children. In this instance, based on all available information, the Agency concludes that there is a finding of no toxicity for Bacillus mycoides isolate J. Thus there are no threshhold effects of concern to infants and children when the microbial is used as a fungicide. Accordingly, the Agency concludes that the additional MOE is not necessary to protect infants and children, and that not adding any additional MOE will be safe for infants and children. VII. Other Considerations A. Endocrine Disruptors The pesticidal active ingredient, Bacillus mycoides isolate J is not known to exert an influence on the endocrine system. B. Analytical Method(s) Analytic methods for Bacillus mycoides isolate J that are sufficient to justify the issuance of an Experimental Use Permit (EUP) have been submitted to the Agency. C. Codex Maximum Residue Level No codex maximum residue levels exist for the microbial Bacillus mycoides isolate J. VIII. Statutory and Executive Order Reviews This final rule establishes a temporary exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. IX. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 * et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 6, 2006. James Jones, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART180—[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 180.1269 is added to subpart D to read as follows: § 180.1269 Bacillus mycoides Isolate J on sugar beets: exemption from the requirement of a tolerance. Bacillus mycoides isolate J is temporarily exempt from the requirement of a tolerance when used as a fungicide for control of Cercospora Leaf Spot ( Cercospora beticola ) on sugar beets. This temporary exemption from the requirement of a tolerance expires and is revoked on December 31, 2007. [FR Doc. E6-9282 Filed 6-13-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0299; FRL-8069-6] Potassium Silicate; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of potassium silicate in or on all food commodities when applied/used as a fungicide, insecticide or miticide so long as the potassium silicate is not applied at rates exceeding 1% by weight in aqueous solution and when used in accordance with good agricultural practices. PQ Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of potassium silicate. DATES: This regulation is effective June 14, 2006. Objections and requests for hearings must be received on or before August 14, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION. ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0299. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Docket is (703) 305-5805. FOR FURTHER INFORMATION CONTACT: Carol E. Frazer, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8810; e-mail address: frazer.carol@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 FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0299 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 August 14, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0299, by one of the following methods: • Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line instructions for submitting comments. • Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The telephone number for the Docket is (703) 305-5805. II. Background and Statutory Findings In the Federal Register of July 27, 2005 (70 FR 43417) (FRL-7719-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 5F6905) by PQ Corporation, P.O. Box 840 Valley Forge, PA 19482-0840. The petition requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of potassium silicate. This notice included a summary of the petition prepared by the petitioner PQ Corporation. There were no comments received in response to the notice of filing. Section 408(c)(2)(A)(I) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Potassium silicate is a synthetic compound that is chemically the potassium salt of silicic acid. It is produced by combining pure silica sand (SiO ² ) and potash (K ² CO ³ or NaCO ³ ). Silicic acid salts (i.e., silicates) are the most common form of silicon. For the purposes of this tolerance exemption, the Agency has relied on the extensive body of knowledge, data and/or information from the public literature as submitted by PQ Corporation and as researched by the Agency which document the similarity of silica (also known as silicon dioxide) and potassium silicate and support the conclusion that there is reasonable certainty of no harm that will result from the use of potassium silicate as an agricultural pesticide. Silicon dioxide (silica) has been assessed for its pesticidal uses by the Agency and it was determined that the toxicity of this compound is moderate to low and therefore, the human health risk is low and not unreasonable. Further, silicon dioxide is recognized by the Food and Drug Administration (FDA) to be a Generally-Recognized As Safe (GRAS) substance, as a food additive (21 CFR 182.90 and 182.1711). Comprehensive reviews and risk assessments have been conducted on silicon dioxide (silica) and its related soluble silicates with regard to its toxicity to human health and have concluded that silica and its soluble silicates (potassium silicate) are low in toxicity and the primary hazard of concern is the corrosive nature of the compound. The corrosive nature of potassium silicate is not of a concern when used as a very dilute solution (less than or equal to 1%). The soluble silicates include: potassium silicate, sodium silicate and sodium metasilicate, the latter of which the Agency has exempted in diluted form from the requirement of a tolerance for use on all food commodities. Additionally, the FDA has determined that sodium silicate and potassium silicate can be used interchangeably which substantiates information in the public literature that the compounds are very similar. The data submitted and reviewed on the end use pesticide product containing 29.1% w/w potassium silicate caused moderate to low dermal irritation and is classified as an eye irritant due to the high pH of the product. When used as a pesticide (fungicide, insecticide and miticide) the active ingredient is effective at very low concentrations (less than or equal to 1%) and thus the dilution of the active ingredient would reduce the risks to pesticide users. Labeling of such products with the appropriate protective clothing, gloves and eyewear would mitigate the risk of exposure to potassium silicate on pesticide applicators. Potassium silicate residues which may result from its use as an agricultural pesticide would be reduced by washing or processing treated commodities before their consumption; this point is supported by the water solubility of potassium silicate and the possibility of it being washed off treated surfaces by rainfall in the field. Further, potassium silicate is neutralized by stomach acid and primarily excreted in the urine. The components of potassium silicate are potassium and silicon. Potassium is found in the environment and is an essential element in human and plant nutrition. It is found in many fruits and vegetables consumed by humans. A common soil plant nutrient and fertilizer (as K ² O), potassium comprises approximately 2.59% of the Earth's crust by weight. The primary source of naturally-occurring soluble potassium is from the weathering of potassium containing minerals. Silicon is ubiquitous in the environment, the second most abundant element in the lithosphere after oxygen. A nutritional element, silica is required for proper and strong growth of mammalian bones. Silica is present naturally in all plant stems and is present in larger amounts in crops such as rice and sugar cane. It comprises approximately 31% of the Earth's crust by weight and is present as dissolved silica, amorphous silica in the solid phase (for example, silica and silica gel (FDA GRAS chemicals), and silica bound to organic matter. In the normal range of soil pH, silicic acid is the major silicate in soil water. In natural waters most dissolved silica results from weathering of silicate minerals. Research demonstrates that commercial soluble silicates rapidly degrade to molecular forms that are indistinguishable from natural dissolved silica (IUCLID, 1995). Beach sand, for example is comprised of nearly 100% silica (Crop Protection handbook, 2003). Additionally, silica is approved by the FDA for use as an anti-caking agent in food. Potassium silicate immediately breaks down in the presence of water to the potassium and silicate ions which are indistinguishable from natural components. As stated above, potassium silicate is produced by direct fusion of precisely measured portions of pure silica sand (SiO ² ) and potash (K ² CO ³ ) in a fired furnace at temperatures above 1000°C. Solutions of potassium silicate are produced by dissolving alkali silica lumps in water at elevated temperatures. Potassium silicate is classified as GRAS by FDA (21 CFR 182.90 and 21 CFR 182.1711) for limited use in canned potable water as a corrosion inhibiting agent and the EPA has exempted potassium silicate from the requirement of a tolerance when used as an inert ingredient, a surfactant, emulsifier, wetting agent, stabilizer, or inhibitor (40 CFR 180.910). Data and/or information from the public literature demonstrates a long history of safe use of fertilizers containing potassium and silica. (HERA 2005, NOSB/TAP, 2003 and the Silicon Dioxide and Silica Gel RED EPA, 1991, Kant, T., et al , 2003, Savant N.K., et al ., 1999). Fertilizers used in the agricultural industry contain plant nutrients and micronutrients such as potassium and silicon. Potassium silicate is approved by the USDA as a fertilizer for conventional agriculture and is used on a variety of crops including rice, wheat, barley, sugar cane, melons, grapes and cucurbits (USDA/ERS, 2002, NOSB/TAP, 2003). As mentioned above, silicon dioxide and its soluble silicates which include potassium silicate have been fully characterized and assessed by the Agency and other notable resources and it has been concluded that silicon dioxide and its related soluble silicates exhibit moderate to low toxicity, the Agency has therefore concluded there is a reasonable certainty of no harm resulting from the use of potassium silicate as an agricultural pesticide. This determination is based on information from the literature which as stated above document the similarity of silica (also known as silicon dioxide) and potassium silicate. This information combined with the fact that the components of potassium silicate (potassium and silica) are already naturally present in the stems of all plants (silica) and naturally in foods supports the Agency's conclusion that there is a reasonable certainty of no harm resulting from the use of potassium silicate as an agricultural pesticide and exposure from the use of potassium silicate as a pesticide will not add to the exposure already present from its natural occurrence, its presence in foods, in the human diet and in the environment. A. Acute Toxicity The registrant did not submit any toxicity data testing the technical grade of the active ingredient. Data waivers were requested by the registrant and granted by the Agency based on the body of extensive knowledge from the public literature and as researched by the Agency. The toxicity of the soluble silicates via oral toxicity, teratogenicity and genotoxicity were tested on the Technical Grade of the Active Ingredient (TGAI) and reported and the Agency has relied upon this information to support its decision to grant the waiver requests for these studies. Acute toxicity data were submitted using the end-use product as the test material which is approximately a ⅓ dilution of the technical grade of the active ingredient. Requests for data waivers were granted for additional toxicity studies described below. These data waiver requests were granted based on the findings from comprehensive reviews and risk assessments conducted on silicon dioxide (silica) and its related soluble silicates (potassium silicate) with regard to its toxicity to human health and the conclusion that silicon dioxide and its related soluble silicates have moderate to low toxicity, and therefore, the Agency concludes that there is a reasonable certainty of no harm resulting from the use of potassium silicate. The data submitted and waivers that were granted are as follows: Acute oral rat OPPTS Harmonized Guideline 870.1100; Master Record Identification (MRID) Number 46434903). LD ⁵⁰ = 5,000 milligrams/kilogram (mg/kg) (29.1% potassium silicate aqueous solution). The test material is classified as a Toxicity Category IV for acute oral toxicity and demonstrates that a dilution of the active ingredient to a level that is comparable to the concentration of potassium silicate in the proposed end-use product eliminates the potential of the active ingredient to cause acute toxic effects. There were no adverse effects reported at 5,000 mg/kg. Technical grade of the active ingredient . A request to waive this data requirement was submitted by the registrant. The Agency has granted this data waiver based on: (1) Data from the public literature which shows soluble silicates have a moderate to low acute toxicity by the oral route (HERA 2005), (2) potassium silicate, a soluble silicate that is both chemically and toxicologically similar to silicon dioxide (silica) which has been fully characterized, assessed, and therefore determined by the Agency that silicon dioxide and its related soluble silicates pose no unreasonable adverse effects to human health when used as an agricultural pesticide and (3) potassium and silica are already present in the human diet as they are contained naturally in various crops. Acute dermal rat OPPTS 870.1200; (MRID 4643902). LD ⁵⁰ = 5,000 mg/kg (29.1% potassium silicate aqueous solution). The test material is classified as a Toxicity Category IV for acute dermal toxicity and demonstrates that a dilution of the active ingredient to a level that is comparable to the concentration of potassium silicate in the proposed end use product will be moderately irritating to the skin. Technical grade of the active ingredient. Section 158.690(c)(2)(I) states this test is not required if the test material is corrosive to skin. Therefore, this test was not required. However, this active ingredient is classified Toxicity Category I on the basis of potential dermal irritation effects. Acute inhalation rat OPPTS 870.1300; (MRID 46434906). LC ⁵⁰ > 2.06 milligrams per liter (mg/L) (29.1% potassium silicate aqueous solution). The test material is classified as a Toxicity Category IV for acute inhalation toxicity and demonstrates that a dilution of the active ingredient to a level that is comparable to the concentration of potassium silicate in the proposed end use product will not cause acute inhalation effects at greater than 2.06 mg/L. Technical grade of the active ingredient . This test is only required if the product consists of a respirable material. Since potassium silicate does not consist of a respirable material under normal conditions of use, this test is not required. B. Genotoxicity, Immune Response, Mutagenicity, Developmental, Oncogenicity, Subchronic and Chronic Toxicity The applicant requested to waive the data requirements below and submitted a summary of public literature to satisfy the data requirements for 90-day oral toxicity (OPPTS 870.3100), genotoxicity (OPPTS 870.5100; 870.5300; 870.5375), teratogenicity (OPPTS 870.3700) and immunotoxicity (OPPTS 880.3550) for the active ingredient. Potassium silicate waiver requests were submitted (MRID 46434701). As mentioned above, the Agency has determined that the data requirements were met by the submission of public literature. The public literature demonstrates that potassium silicate has low toxicity by the oral route when tested as the TGAI because potassium silicate is neutralized by stomach acid and primarily excreted in the urine. The high pH of the pesticide product may cause eye and skin irritation to humans. However, risks to humans will be reduced by dilution of the pesticide product and further mitigated by the use of protective personal equipment. IV. Aggregate Exposures In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure 1. Food . Potassium is found in the environment and is present in the cells of humans and plants and is therefore an essential element in human and plant nutrition. It is found in many fruits and vegetables consumed by humans. Humans require an adequate supply of potassium from consumption of foods for healthy growth and development. Humans consume daily many sources of potassium, including a variety of fruits, vegetables and beverages such as barley, bananas, plums, apricots, strawberries, oranges, apples, grapes, spinach, potatoes, carrots, celery, tomatoes, lettuce, cucumbers, milk, fruit juices, coffee, white wine and light beers, etc. The average potassium content of the above fruits and vegetables ranges from 2.4 K/kg (tomato) - 3.7 K/kg (banana). As mentioned above, potassium is a common soil plant nutrient and fertilizer (as K ² O), and comprises approximately 2.59% of the Earth's crust by weight. Silicon is a ubiquitous mineral nutrient in the environment (soil, water) and the second most abundant element in the lithosphere after oxygen. A nutritional trace element, silicon is required for proper and strong growth and development of mammalian bones. In plants, silicic acid (Si(OH) ⁴ ) is rapidly absorbed. Once absorbed, silicic acid is readily circulated throughout the plant and deposited as silicon dioxide. Consequently exposure to soluble silica occurs on a daily basis and is a property of all plant products in the human diet. The concentration of silicon in vegetable plants varies greatly with cereals and grasses containing the highest concentrations (0.2-2.0%). Good agricultural practice when using potassium silicate means it will most likely be used in aqueous solutions because application of pure potassium silicate to crops is likely to be corrosive to crops since the active ingredient is a known corrosive. When applied to food crops at concentrations not to exceed 1% by weight of potassium silicate in aqueous solution, it is highly unlikely there will be any residues of significance in or on food. Further dilution by tank mixing with water of a pesticide product containing the active ingredient at 29% w/w of potassium silicate before application of the pesticide reduces the amount of active ingredient (to concentrations not to exceed 1% active ingredient) that will be on the crop. Furthermore, potassium silicate breaks down in the presence of water to potassium and silicate ions, both of which occur naturally in animals and plants. Concentrations of potassium silicate as a pesticide in foliar sprays and nutrient solutions are dominated by silicic acid, which as mentioned above, is readily absorbed by plants. Therefore, given the use dilution of the pesticide product and other good agricultural practices as required on product labels, the likely dietary exposures to potassium silicate from the pesticidal uses are not expected to add significantly to those levels of potassium silicate already found in foods, beverages, and in drinking water as a result of conventional agriculture and its natural occurrence in the environment. 2. Drinking water exposure . Because potassium silicate breaks down into potassium and silicate ions in the presence of water, there will be no residues of potassium silicate in drinking water from its use as a pesticide. The Agency does not expect the resulting potassium and silicate ions resulting from this breakdown process will add significantly to the level of potassium and silica presently in the water. Potassium and silicon dioxide are ubiquitous in the environment, and the uses of soluble silicates are widespread in dishwashing soaps, other soaps, and detergents. Potassium silicate is classified by the FDA as a GRAS substance (21 CFR 182.90 and 21 CFR 182.1711) for limited use in canned potable water as a corrosion inhibiting agent. Moreover, both potassium and silicon are already present in natural waters. The potassium (natural) content of drinking water varies greatly depending on its source and may be larger in mineral and spa waters than ordinary tap water. On average, the daily water consumption by adults supplies less than 0.1% of their potassium intake (European Fertilizer Manufacturers Association, 1997). In natural waters most dissolved silica results from weathering of silicate minerals and it has been demonstrated that commercial soluble silicates rapidly degrade to molecular forms that are indistinguishable from natural dissolved silica. Therefore, because of the levels at which potassium and silica (silicon dioxide) are already present in the water supply, the Agency does not expect that the use of potassium silicate as a pesticide will result in detectable exposures aside from what is currently in the environment. B. Other Non-Occupational Exposure 1. Dermal exposure . Non-occupational dermal exposures to potassium silicate when used as a pesticide are expected to be negligible because it is limited to agricultural use. 2. Inhalation exposure . Non-occupational inhalation exposures to potassium silicate when used as a pesticide are expected to be negligible because it is limited to agricultural use and will be used as a spray. V. Cumulative Effects Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency considers available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity. The information available at this time indicates that potassium silicate when applied to food crops at a rate less than or equal to 1% of potassium silicate by weight in aqueous solution does not have a toxic effect. Therefore, cumulative effects from the residues of this product are not anticipated. VI. Determination of Safety for U.S. Population, Infants and Children 1. U.S. population . The Agency has determined that there is reasonable certainty that no harm will result to the U.S. population from aggregated exposure to residues of potassium silicate when used in an aqueous solution in which the potassium silicate does not exceed 29.1% by weight. This includes all anticipated dietary exposures and other exposures for which there is reliable information. The Agency arrived at this conclusion based on the anticipated low acute exposure estimates from its pesticidal use, the low mammalian toxicity in its diluted form, the widespread exposure to potassium and silica, from foods in the human diet, and the similarity both chemically and toxicologically to silicon dioxide which has already been fully characterized and assessed, and found that there is reasonable certainty of no harm that will result from the use of silicon dioxide and its related soluble silicates (potassium silicate) as an agricultural pesticide. 2. Infants and children . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure (MOE) for infants and children in the case of threshold effects. Margins of exposure are often referred to as uncertainty or safety factors, and are used to account for potential prenatal and postnatal toxicity and any lack of completeness of the data base. Based on available data and other information, EPA may determine that a different MOE will define a level of concern for infants and children or that a MOE approach is not appropriate. Based on all the available information the Agency reviewed on potassium silicate, including a lack of threshold effects, the Agency concluded that potassium silicate, in its diluted form, is practically non-toxic to mammals, including infants and children. Since there are no effects of concern, the provision requiring an additional margin of safety does not apply. VII. Other Considerations A. Endocrine Disruptors Based on available data, no endocrine system-related effects have been identified with consumption of potassium silicate. In addition, there is no evidence to suggest that potassium silicate functions in a manner similar to any known hormone. B. Analytical Method(s) The Agency proposes to establish an amendment to the exemption from the requirement of a tolerance without any numerical limitation for residues since it has determined that residues resulting from the pesticidal uses of potassium silicate would be so low as to be indistinguishable from the naturally occurring silicates that are ubiquitous in the environment. C. Codex Maximum Residue Level There are no Codex Maximum Residue Levels for this chemical. VIII. Conclusions Based on the toxicology data submitted, there is reasonable certainty no harm will result to the U.S. population including infants and children from aggregate exposure of residues of potassium silicate when the product is used in accordance with good agricultural practices. This includes all anticipated dietary exposures and all other exposures about which there is reliable information. As a result, EPA establishes an exemption from tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of potassium silicate in or on all food commodities so long as the potassium silicate is not applied to food crops at rates that exceed 1% potassium silicate by weight in an aqueous solution. IX. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the exemption 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. The Agency hereby certifies that this rule will not have significant negative economic impact on a substantial number of small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. X. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 31, 2006. James Jones, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.1268 is added to subpart D to read as follows: § 180.1268 Potassium silicate; exemption from the requirement of a tolerance. Potassium silicate is exempt from the requirement of a tolerance in or on all food commodities so long as the potassium silicate is not applied at rates exceeding 1% by weight in aqueous solution and when used in accordance with good agricultural practices. [FR Doc. E6-8939 Filed 6-13-06; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [WT Docket No. 05-211; FCC 06-78] Commercial Spectrum Enhancement Act and Modernization of the Commission's Competitive Bidding Rules and Procedures AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Federal Communications Commission, on its own motion, clarifies certain aspects of the Implementation of the Commercial Spectrum Enhancement Act and Modernization of the Commission's Competitive Bidding Rules and Procedures. Among other things, the Commission clarifies that the expansion of the unjust enrichment payment schedule to ten years applies only to licenses granted on or after April 25, 2006. This ensures that retroactive penalties are not imposed on pre-existing designated entities. DATES: Effective June 14, 2006. FOR FURTHER INFORMATION CONTACT: Brian Carter at (202) 418-0660. SUPPLEMENTARY INFORMATION: This is a summary of the Order on Reconsideration of the Second Report and Order ( Order on Reconsideration ) released on June 2, 2006. The complete text of the Order on Reconsideration including attachments and related Commission documents is available for public inspection and copying from 8 a.m. to 4:30 p.m. Monday through Thursday or from 8 a.m. to 11:30 a.m. on Friday at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The Order on Reconsideration and related Commission documents may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc. (BCPI), Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 202-488-5300, facsimile 202-488-5563, or you may contact BCPI at its Web site: http://www.BCPIWEB.com . When ordering documents from BCPI please provide the appropriate FCC document number, for example, FCC 06-78. The Order on Reconsideration and related documents are also available on the Internet at the Commission's Web site: http://wireless.fcc.gov/auctions. I. Introduction 1. The Commission, on its own motion, released an Order on Reconsideration which clarifies certain aspects of the Implementation of the Commercial Spectrum Enhancement Act and Modernization of the Commission's Competitive Bidding Rules and Procedures, Second Report and Order ( Designated Entity Second Report and Order ), 71 FR 26245, (May 4, 2006). The Commission also addresses certain procedural issues raised in filings submitted in response to the Designated Entity Second Report and Order. II. Background 2. In the Further Notice of Proposed Rule Making in this proceeding ( FNPRM ), 71 FR 6992 (February 10, 2006), the Commission sought comment on a proposal by a commenter that the Commission restrict the award of designated entity benefits to designated entities that have material relationships with large in-region incumbent wireless service providers. The Commission asked for comment on each of the elements of this proposal, including what types of material relationships should trigger a restriction on the availability of designated entity benefits and what types of entities other than large in-region incumbent wireless service providers should be covered. 3. In the Designated Entity Second Report and Order , the Commission revised its Part 1 rules to include certain material relationships as factors in determining designated entity eligibility. Specifically, the Commission adopted rules to limit the award of designated entity benefits to any applicant or licensee that has impermissible material relationships or an attributable material relationship created by certain agreements with one or more other entities for the lease or resale (including under a wholesale arrangement) of its spectrum capacity. The Commission found that these additional eligibility restrictions were necessary to meet its statutory obligations and to ensure that, in accordance with the intent of Congress, every recipient of the Commission's designated entity benefits is an entity that uses its licenses to directly provide facilities-based telecommunications services for the benefit of the public. In particular, the Commission determined that the relationships underpinning such leasing and resale agreements underscored the need for stricter regulatory parameters to ensure that benefits were reserved to provide opportunities for designated entities to become robust independent facilities-based service providers with the ability to provide new and innovative services to the public, and to prevent the unjust enrichment of unintended beneficiaries. 4. In the FNPRM , the Commission also sought comment on whether, if it adopted a new restriction on the award of bidding credits to designated entities, the Commission should adopt revisions to its unjust enrichment rules. The Commission asked over what portion of the license term the unjust enrichment provisions should apply if it decided to require reimbursement by licensees that, either through a change of material relationships or assignment or transfer of control of the license, lose their eligibility for a bidding credit pursuant to any eligibility restriction that it might adopt. In the Designated Entity Second Report and Order , the Commission adopted rule modifications to strengthen its unjust enrichment rules in order to better deter entities from attempting to circumvent its designated entity eligibility requirements and to recapture designated entity benefits when ineligible entities control designated entity licenses or exert impermissible influence over a designated entity. Specifically, the Commission adopted a ten-year unjust enrichment schedule for licenses acquired with bidding credits. 5. Finally, in the Designated Entity Second Report and Order , in order to ensure its continued ability to safeguard the award of designated entity benefits, the Commission explained how it will implement its rules concerning audits, particularly with respect to designated entities that win licenses in the upcoming AWS auction, and refined its rules with respect to the reporting obligations of designated entities. In the Order on Reconsideration , the Commission provides guidance on these implementation rules as well as on the substantive rules mentioned above. 6. Several parties have submitted filings in this docket addressing various aspects of the Designated Entity Second Report and Order . Among the filing are a petition for expedited reconsideration and two supplements. III. Discussion A. Section 309(j)(3)(E)(ii) 7. Certain parties assert that the Commission's application of the new designated entity rules to the licenses offered in Auction No. 66 violates section 309(j)(3)(E)(ii) of the Communications Act, a directive that the Commission ensure that, after it issues bidding rules, interested parties have sufficient time to develop business plans, assess market conditions, and evaluate the availability of equipment for the relevant services. The Commission disagrees. 8. The Commission rejects the basic assumption that the new designated entity rules implicate section 309(j)(3)(E)(ii) at all and concludes that while that provision instructs the Commission to promote the objective of ensuring that interested parties after the issuance of bidding rules have a sufficient time to develop business plans, assess market conditions, and evaluate the availability of equipment for the relevant services, the new designated entity rules do not constitute bidding rules for purposes of section 309(j)(3)(E)(ii). The Commission has explained that this provision does not require the Commission to postpone an auction until every external factor that might influence a bidder's business plan is resolved with absolute certainty. Rather, the provision applies to auction-specific information and specific mechanisms relating to day-to-day auction conduct. The new designated entity rules included neither auction-specific information nor specific mechanisms relating to day-to-day auction conduct. Therefore, the Commission concluded that it does not believe that they fall under the rubric of section 309(j)(3)(E)(ii). 9. The Commission also notes that parties were on notice for many months of the Commission's intent to apply the changes to the designated entity rules adopted in the proceeding to licenses issued in Auction No. 66. The Commission finds that parties had ample warning that a change in the designated entity rules was coming and should have been prepared to react as soon as the new rules were announced. The Commission concludes that while parties complain that the then-existing short-form filing deadline for Auction No. 66 was two weeks after the release of the new designated entity rules, auction applicants are permitted, even after the short-form filing deadline, to take a variety of steps to develop business plans, assess market conditions, and evaluate the availability of equipment for the relevant services, including adding non-controlling investors at any time before or during the auction. 10. The Commission notes that it has rescheduled the deadline for filing short-form applications to participate in Auction No. 66, and interested parties have until June 19, 2006, or 54 days after the release of the Designated Entity Second Report and Order to file their applications. The auction itself is scheduled to take place on August 9, 2006. The Commission also notes that even assuming that section 309(j)(3)(E)(ii) applies to these rules, this new schedule provides applicants with more than sufficient time to adjust business plans and reevaluate market conditions in light of the new designated entity rules. 11. The Commission asserts that section 309(j)(3) requires the Commission to balance several statutory objectives and that the Commission promote several other objectives in exercising its competitive bidding authority, including the rapid deployment of new technologies and services to the public, promotion of economic opportunity and competition, recovery for the public of a portion of the value of the spectrum and avoidance of unjust enrichment, and efficient and intensive use of the spectrum. The Commission emphasizes that two of these other statutory objectives are of particular importance here: (1) Promoting the development and rapid deployment of new technologies, products, and services for the benefit of the public; and (2) avoiding unjust enrichment. The Commission believes that these objectives impose on it an obligation to avoid unnecessary or unreasonable delays of Auction No. 66. The Commission has evidence that potential bidders have an immediate need for the licenses that will be offered in Auction No. 66 and that delaying the auction would impair the rapid deployment of affordable wireless service to the public. Indeed, there is evidence in the record that suggests that delaying the auction further will impede the ability of smaller entities to successfully obtain licenses in Auction No. 66, even though parties claim that the Commission's new rules will deter small businesses from participating in the auction. The alternative proposed by the various parties of holding Auction No. 66 as currently scheduled but setting aside the Commission's new designated entity rules with respect to the licenses offered in that auction, would put the Commission in the position of neglecting its statutory duty to avoid unjust enrichment by assuring that designated entity benefits go to those entities that use their licenses to provide facilities-based services for the benefit of the public. The additional alternative proposed by parties of delaying the auction to allow further comment on the rules adopted in the Designated Entity Second Report and Order would constitute unreasonable delay in light of its statutory obligation to promote the development and rapid deployment of services for the benefit of the public. For all of these reasons, the Commission continues to believe that it has reasonably balanced the objectives set forth in section 309(j)(3) and that proceeding with the auction as scheduled would best serve the public interest. B. Material Relationships 12. Notice. Certain parties argue that the Commission violated the Administrative Procedure Act by adopting the new material relationship rules. They contend, first, that the Commission failed to give sufficiently specific notice, and thus sufficient opportunity for comment, on the new restrictions on leasing and resale arrangements. Second, they argue that the Commission made certain aspects of the rules immediately effective without the requisite statutory notice. The Commission finds both claims unconvincing. 13. An agency is not required to adopt a final rule that is identical to the proposed rule. In fact agencies are encouraged to modify proposed rules as a result of the comments they received. As long as parties could have anticipated that the rules ultimately adopted was possible, it is considered a logical outgrowth of the original proposal, and there is no violation of the APA's notice requirements. 14. Applying these standards, it is clear that there was ample notice of the new material relationship rules in this case. The FNPRM emphasized the Commission's ongoing commitment to prevent companies from circumventing the objectives of the designated entity eligibility rules and to ensuring that its small business provisions are available only to bona fide small businesses. The Commission noted the concern raised in the record that those rules did not adequately prevent large corporations from structuring relationships in a manner that allows them to gain access to benefits reserved for small businesses. While the Commission tentatively proposed adoption of the parties rule, the Commission sought comment on whether other material relationships should trigger a restriction on the award of designated entity benefits. In the FNPRM , the Commission asked among other things whether limiting the prohibited material relationships to large incumbent wireless service providers or entities with significant interests in communications services would be sufficient to address any concerns that its designated entity program may be subject to potential abuse from larger corporate entities. 15. The FNPRM made clear that the Commission was considering several approaches to defining a material relationship and broadly sought comment on the specific nature of the relationship that should trigger such a restriction. 16. While parties claim that they had no notice that an arrangement such as lease or resale could constitute a material relationship, the FNPRM specifically contemplated it. The Commission noted that in its Secondary Markets proceeding, it had concluded that certain spectrum manager leases between a designated entity licensee and a non-designated entity lessee would cause the spectrum lessee to become an attributable affiliate of the licensee, thus rendering the licensee ineligible for designated entity benefits and making such a spectrum lease impermissible. The Commission then sought comment on whether it should follow a similar approach. Commenting parties clearly understood that the Commission was contemplating rule changes that would extend beyond material relationships with incumbent wireless carriers. 17. After reviewing the record, the Commission concluded that certain agreements between designated entities and others are generally inconsistent with Congress's legislative intent. Specifically, the Commission explained that where an agreement concerns the actual use of the designated entity's spectrum capacity, it is the agreement, as opposed to the party with whom it is entered into, that causes the relationship to be ripe for abuse and creates the potential for the relationship to impede a designated entity's ability to become a facilities-based provider, as intended by Congress. Accordingly, the Commission adopted rules in the Designated Entity Second Report and Order to limit the award of designated entity benefits to any applicant or licensee that has impermissible material relationships or an attributable material relationship created by agreements with one or more other entities for the lease or resale (including under a wholesale arrangement) of its spectrum capacity. 18. These rules were a logical outgrowth of the questions the Commission asked in the FNPRM and are well within the scope of the inquiry initiated there. The fact that the Commission elected to adopt a definition of material relationship that differed from that specifically proposed by one of the parties does not mean that the Commission failed to provide notice of the rule modifications it ultimately adopted. 19. The Commission disagrees with the contention by various parties that it made certain aspects of the rules immediately effective and finds that such an argument is based on a gross misreading of the rule. The reference to the date of the release in the new rule did not impose any consequences on parties immediately following the date of release. Rather, once the rules became effective—30 days after Federal Register publication—actions taken following the release might affect a party's status, but only if not undone in the period before the rule became effective. Thus, parties had the requisite period of notice to adjust in response to the new rule. 20. Requests for General Clarification. After releasing the Designated Entity Second Report and Order, Commission staff received a number of questions seeking general advice regarding how the Commission intended to implement its rule modifications. The Commission therefore clarifies how it will consider: (1) The meaning of spectrum capacity in the context of material relationships, (2) grandfathering, and (3) applicability of the rules to particular services. 21. Material Relationships. The Commission noted that a number of questions have been raised regarding how the Commission will evaluate impermissible and attributable material relationships for the purposes of determining eligibility for both designated entity benefits and the imposition of unjust enrichment. In the Designated Entity Second Report and Order , the Commission concluded that an applicant or licensee has impermissible material relationships when it has agreements with one or more other entities for the lease (under either spectrum manager or de facto transfer leasing arrangements) or resale (including under a wholesale arrangement) of, on a cumulative basis, more than 50 percent of the spectrum capacity of any individual license. The Commission decided that such impermissible material relationships would render the applicant or licensee (i) ineligible for the award of future designated entity benefits, and (ii) subject to unjust enrichment on a license-by-license basis. The Commission further concluded that an applicant or licensee has an attributable material relationship when it has one or more agreements with any individual entity, including entities and individuals attributable to that entity, for the lease (under either spectrum manager or de facto transfer leasing arrangements) or resale (including under a wholesale arrangement) of, on a cumulative basis, more than 25 percent of the spectrum capacity of any individual license that is held by the applicant or licensee. The Commission decided that such an attributable material relationship would be attributed to the applicant or licensee for the purposes of determining the applicant's or licensee's (i) eligibility for future designated entity benefits, and (ii) liability for unjust enrichment on a license-by-license basis. As stated in the Designated Entity Second Report and Order , the Commission's policy is to assure that a designated entity preserves at least half of the spectrum capacity of each license for which the designated entity has been awarded and retained designated entity benefits in exchange for the provision of service as a facilities-based provider for the benefit of the public. 22. Meaning of Spectrum Capacity. In the Order on Reconsideration, the Commission also clarifies how it will measure compliance with the thresholds it adopted in its definitions of material relationships. The restrictions it adopted regarding impermissible and attributable material relationships require a designated entity to assess the percentage of its spectrum capacity that will be leased (under either spectrum manager or de facto transfer leasing arrangements) or subject to resale (including under a wholesale arrangement). In response to request for clarification, the Commission provides additional guidance on determining the percentage of a designated entity's spectrum capacity involved in lease or resale agreements. 23. The Commission observes, as an initial matter, that there are a number of ways spectrum capacity could be defined. It would be difficult for the Commission to enumerate every possible means by which a licensee could lease or make its spectrum capacity available to another party to resell. By adopting spectrum capacity as a measurement, the Commission sought to provide licensees with some flexibility to tailor their agreements to their business needs. The Commission is reluctant to employ only a single measure of spectrum capacity. Nevertheless, to assist designated entities as they evaluate secondary market transactions, the Commission clarifies that if they meet the spectrum capacity thresholds on an MHz* pops basis, the Commission will find them in compliance. The MHz* pops basis is consistent with the Commission's current method of apportioning unjust enrichment when licenses are partitioned and/or disaggregated and provides a meaningful measure here. However, while meeting the spectrum capacity thresholds on an MHz * pops basis is sufficient to comply with the Commission's rules, it is not the only means of compliance. In other words, any entity meeting the thresholds on an MHz* pops basis will be found in compliance, but entities not meeting the thresholds on an MHz* pops basis may also be found in compliance based on other factors. The MHz* pops measure is intended as a safe harbor; it is not meant to limit complying with the rules in other ways that the Commission cannot fully anticipate at this time. The Commission recognizes that its decision not to enumerate all other means of compliance necessarily leaves some uncertainty, but thinks that the MHz* pops safe harbor provides sufficient certainty while allowing licensees and the Commission flexibility to conduct a more contextual analysis. 24. Grandfathering. In the Designated Entity Second Report and Order, the Commission explained that it would not employ its new restrictions to reconsider the eligibility for any designated entity benefits that had been awarded to licensees prior to the April 25, 2006, release date of the decision or to determine eligibility for designated entity benefits in an application for a license, an authorization, or an assignment or transfer of control, or a spectrum lease that had been filed with the Commission before, and was still pending approval on, that date. 25. The Commission received a number of inquiries regarding how the Commission will consider future agreements that were agreed upon prior to the release date of its decision. The Commission therefore offers the following explanation: Agreements entered into by a designated entity—and, to the extent required, approved by or pending approval by the Commission—no later than April 24, 2006 that concern the lease or resale by the designated entity of its spectrum after the release date of the Designated Entity Second Report and Order are grandfathered for the purposes of existing eligibility benefits and the imposition of unjust enrichment to the extent that the designated entity has no discretion as to the future lease or resale. The applicability of grandfathering to the future lease or resale of spectrum in a pre-existing agreement depends on whether or not the provision was a “done deal” such that, prior to April 25, 2006, the decision to lease or to allow the resale of spectrum was no longer within the discretion of the designated entity. 26. Applicability of Material Relationships Rules to Certain Services. The Commission notes that there has also been some question about the applicability of the new material relationship rules with regard to agreements to lease spectrum in the 700 MHz Guard Band Manager Service and those other services not covered by the Commission's secondary market leasing policies. Consequently, the Commission clarifies that the new material relationship rules will apply only to those services in which leasing are permitted under the Commission's secondary markets rules. C. Unjust Enrichment 27. Notice. Various parties argue that the Commission violated the Administrative Procedure Act by giving inadequate notice and opportunity for comment prior to adopting new unjust enrichment provisions. The Commission concludes that this claim is refuted by the plain language of the FMPRM and by the parties' own filings in response to it. 28. In the FMPRM , the Commission observed that the existing rules require the payment of unjust enrichment when an entity that acquires its license with small business benefits loses its eligibility for such benefits or transfers a license to another entity that is not eligible for the same level of benefits. The Commission also noted that a commenter had proposed extending this reimbursement obligation to any licensee that acquires a license with the help of a bidding credit but then makes a change in its material relationships or seeks to assign or transfer control of the license to an entity that would result in its loss of eligibility for the bidding credit pursuant to any eligibility restriction that the Commission adopt. According to the commenter strengthening the unjust enrichment rules was necessary to fulfill the Commission's statutory obligation to prevent unjust enrichment. The FMPRM sought comment both on the commenter's specific proposal and on whether the Commission should seek to strengthen the unjust enrichment rules in some other manner. The Commission also asked a series of questions about the scope of the reimbursement obligation, seeking comment on whether it should be triggered only where the licensee takes on new investment or also when it enters into any new material financial relationship or material operational relationship that would have rendered the licensee ineligible for a bidding credit. Finally, while the Commission noted the commenter's proposal for a five-year reimbursement obligation, the Commission did not tentatively propose adopting it. Instead, it asked over what portion of the license term should the unjust enrichment provisions apply. 29. Notwithstanding the broad scope of the questions asked by the FMPRM , the commenter claims that parties had no notice that the Commission was contemplating any changes to its unjust enrichment rules. The FMPRM makes clear the Commission did not put itself in such a straitjacket, and it would have been unreasonable for any party to believe that the Commission had done so. Nowhere did the Commission say it would consider only a five-year reimbursement obligation or that it would artificially limit the rule changes only to relationships with particular entities. Indeed, the comments filed in response to the FMPRM demonstrate that parties did in fact understand the scope of the contemplated changes to the unjust enrichment rules. 30. The changes the Commission ultimately adopted to its unjust enrichment rules were clearly within the scope of the revisions contemplated by the FMPRM or, at a minimum, a logical outgrowth of them. Indeed, had the Commission only revised the five-year unjust enrichment schedule for certain types of transactions but not for others, the Commission would have risked creating an illogical scheme that would have created an incentive for designated entities to prioritize certain types of transactions over others. For all of these reasons, the Commission rejects the parties' APA notice claim. 31. Impact of New Rules. In the Designated Entity Second Report and Order, the Commission adopted changes to its unjust enrichment rules to ensure that designated entity benefits go to their only intended beneficiaries. The Commission agreed with commenters that the adoption of stricter unjust enrichment rules would increase the probability that the designated entity would develop into a competitive facilities-based service provider and deter speculation by those who do not intend to offer service to the public, or who intend to use bidding credits to obtain a license at a discount and later to sell it at the full market price for a windfall profit. 32. The Commission therefore modified its unjust enrichment rules to expand the unjust enrichment payment schedule from five to ten years. Further, the Commission required that it be reimbursed for the entire bidding credit amount owed if a designated entity loses its eligibility for a bidding credit prior to the filing of the applicable construction notifications. Specifically, the Commission adopted the following ten-year unjust enrichment schedule for licenses acquired with bidding credits. For the first five years of the license term, if a designated entity loses its eligibility for a bidding credit for any reason, including but not limited to, entering into an impermissible material relationship or an attributable material relationship, seeking to assign or transfer control of a license, or entering into a de facto transfer lease with an entity that does not qualify for bidding credits, 100 percent of the bidding credit, plus interest, is owed. For years six and seven of the license term, 75 percent of the bidding credit, plus interest, is owed. For years eight and nine, 50 percent of the bidding credit, plus interest, is owed, and for year ten, 25 percent of the bidding credit, plus interest, is owed. The Commission also imposed a requirement that the Commission must be reimbursed for the entire bidding credit amount owed, plus interest, if a designated entity loses its eligibility for a bidding credit for any reason, including but not limited to, entering into an impermissible material relationship or an attributable material relationship, seeking to assign or transfer control of a license, or entering into a de facto transfer lease with an entity that is not eligible for bidding credits prior to the filing of the notification informing the Commission that the construction requirements applicable at the end of the license term have been met. 33. Various parties assert that the new provisions will eliminate designated entities' access to capital and financing. For several reasons, these claims do not justify reconsideration of the recent rule changes. The parties assert that designated entities access to capital will be eliminated by the 10-year unjust enrichment payment schedule because private equity and other investors frequently adhere to three to seven year investment horizons, with five years being an accepted average. Given the Commission's recent finding that access to Educational Broadcast Service spectrum for longer than fifteen years is essential to attract the capital needed to deploy facilities for spectrum based services, the Commission is not convinced that the appropriate investment horizon for designated entity status should be only three to seven years. Designated entity benefits are offered to ensure that small businesses have an opportunity to participate in the provision of spectrum-based services, not to ensure the short-term exit strategies of parties providing capital. The Commission strengthened its rules to ensure that those that receive such benefits were properly motivated to build out their spectrum and provide services for the benefit of the public by closing off the opportunity to sell licenses awarded with bidding credits for huge profits without ever having to provide actual facilities-based services. Predictions regarding the new rules' effect on venture capital alone are not a basis for reconsidering the rules. 34. In the Order on Reconsideration, the Commission noted that even if some sources of financing and capital would no longer be available on the same terms as before, the adoption of new rules is not arbitrary and capricious, or otherwise contrary to law. The Commission must balance the various statutory objectives of Section 309(j), and based on the record in response to the FMPRM and many years of experience, the Commission found that the new unjust enrichment rules are necessary to increase the probability that designated entities will develop into facilities-based providers of service for the benefit of the public. It is neither the Commission's statutory responsibility nor its intent merely to provide small businesses with generalized economic opportunities in connection with spectrum licenses. The Commission has not been charged with providing entities with a path to financial success, but rather with an obligation to facilitate opportunities for small businesses to provide spectrum based services to the public. Therefore, it is the Commission's responsibility to create strong incentives for designated entities to use spectrum to provide facilities-based service to the public instead of holding their licenses and selling them for profit. The Commission concluded that it believes that its new rules create appropriate incentives in this regard while still affording designated entities the opportunity to achieve financial success by providing service to the public. It is important to remember that designated entities are provided with bidding credits in order to enable them to obtain spectrum and then provide facilities-based service to the public. To the extent that they do not do so, but instead sell their licenses to others in the marketplace at market prices, the Commission believes that it is reasonable that they no longer be allowed to enjoy the benefit of obtaining spectrum at below-market prices. 35. Clarification . In the Order on Reconsideration, the Commission clarifies its statement in the Designated Entity Second Report and Order that retroactive penalties will not be imposed on pre-existing designated entities. Specifically, the Commission clarifies that the newly-adopted ten-year unjust enrichment schedule applies only to licenses that are granted after the release of the Designated Entity Second Report and Order. Likewise, the requirement that the Commission be reimbursed for the entire bidding credit amount owed if a designated entity loses its eligibility for a bidding credit prior to the filing of the notifications informing the Commission that the construction requirements applicable at the end of the license term have been met applies only to those licenses that are granted on or after the April 25, 2006 release date of the Designated Entity Second Report and Order . The Commission also makes corresponding corrections to section 1.2111 of its rules. D. Review of Agreements, Annual Reporting Requirements, and Audits 36. In the Order on Reconsideration, the Commission also clarifies and emphasizes certain aspects of section 1.2114, its newly-adopted rule relating to reportable eligibility events. As the rule expressly states, a designated entity must seek Commission approval for all reportable eligibility events. In the Designated Entity Second Report and Order, the Commission emphasizes that section 1.2114 requires prior Commission approval for a reportable eligibility event. The Commission also clarifies that a reportable eligibility event includes any event that might affect a designated entity's ongoing eligibility, under either its material relationship or controlling interest standards, and it corrects new section 1.2114(a) accordingly. Although the Commission affirms that it has delegated authority to the Wireless Telecommunications Bureau (Bureau) to implement its rule changes on reporting, the Commission anticipates that the Bureau's procedures will provide the means by which parties will apply for approval of all such arrangements. Such approval may require modifications to the terms of the parties' arrangements or unjust enrichment payments based on the impact of such arrangements on designated entity eligibility. The Commission also affirms its conclusions in the Designated Entity Second Report and Order with regard to the implementation of its regulations relating to the review of long-form applications and agreements to determine designated entity eligibility under the controlling interest standard. The Commission also affirms its event-based and annual reporting requirements as well as its commitment to audit the eligibility of every designated entity that wins a license in the AWS auction at least once during the initial term. E. Regulatory Flexibility Act 37. In the Order on Reconsideration, the Commission disagrees with the claims of the various parties that its recently adopted rules violate the Regulatory Flexibility Act (RFA). Among other things, the parties assert that the Commission failed to provide adequate notice in the Initial Regulatory Flexibility Analysis (IRFA) about the scope of the proposed rules, their application to current designated entity licensees, or the ten-year unjust enrichment schedule for licenses acquired with bidding credits. The Commission notes as an initial matter that the IRFA is not subject to judicial review. Section 611 of the RFA expressly prohibits courts from considering claims of non-compliance with the initial regulatory flexibility analysis requirement of RFA section 603. Moreover, the parties have not articulated the legal basis for their claim that a purported lack of notice constitutes an independent violation of the RFA. In any case, the Commission has demonstrated above that the FNPRM provided ample notice of the possible rules changes at issue. For the same reason, any claim about the sufficiency of the Final Regulatory Flexibility Analysis (FRFA) based on charges of inadequate notice of lack of opportunity of comment is also without merit. 38. The Commission also disagrees with the claims of the various parties that the Commission failed to describe significant alternatives to the rules it adopted in order to minimize any significant economic impact on small entities as required by the RFA. The Final Regulatory Flexibility Analysis (FRFA) in the Designated Entity Second Report and Order referred to the substantive part of the Order, which discussed in great depth the impact of the rules on small businesses, alternatives considered, and why the Commission adopted the rules at issue. Reiteration of the discussion of the impact on small businesses in the FRFA is not required by the RFA and such reiteration would have been repetitive here, as analyses of alternatives related to small businesses infuse the decision. In adopting the Commission's rule modifications to better achieve Congress's plan, the Commission fully explained that it was finding a reasonable balance between the competing goals of first, providing designated entities with reasonable flexibility in being able to obtain needed financing from investors and, second, ensuring that the rules effectively prevent entities ineligible for designated entity benefits from circumventing the intent of the rules by obtaining those benefits indirectly, through their investments in qualified businesses. Consistent with previous changes the Commission has made to its designated entity rules, the rule modifications at issue were the result of trying to maintain this balance in the face of a rapidly evolving telecommunications industry, legislative changes, judicial decisions, and the demand of the public for greater access to wireless services. Consequently, the Commission believes that its analysis fully complied with the requirements of the RFA. IV. Conclusion 39. For all of the reasons set forth in the Order on Reconsideration the Commission clarifies certain aspects of the Second Report and Order as well as its rules for determining the eligibility of applicants for size-based benefits in the context of competitive bidding. V. Procedural Matters A. Paperwork Reduction Act Analysis 40. This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198. B. Congressional Review Act 41. The Commission will include a copy of the Order on Reconsideration of the Second Report and Order in a report it will send to Congress and the Government Accountability Office pursuant to the Congressional Review Act. C. Effective Date 42. The Order on Reconsideration of the Second Report and Order and the accompanying rule changes are effective upon publication in the Federal Register . The Commission finds there is good cause under section 553(d)(3) of the Administrative Procedure Act to make the changes it implements with this Order effective upon Federal Register publication, without the usual 30-day period, because these changes (with the possible exception of those concerning the unjust enrichment rules) constitute minor points of clarification of the rules adopted in the Designated Entity Second Report and Order , which were published in the Federal Register on May 4, 2006, 71 FR 26245. As to the clarifying changes in the Commission's unjust enrichment rules, these changes, at most, serve to “grant[ ] or recognize[ ] an exemption or relieve[ ] a restriction” and would therefore fall within the exception contained in section 553(d)(1). D. Ordering Clause 43. It is ordered that pursuant to the authority granted in sections 4(i), 5(b), 5(c)(1), 303(r), and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 155(b), 155(c)(1), 303(r), and 309(j), the Order on Reconsideration of the Second Report and Order , is hereby ADOPTED and part 1, subpart Q of the Commission's rules are amended as set forth in the rule changes, effective June 14, 2006. List of Subjects in 47 CFR Part 1 Administrative practice and procedures, Auctions, Licensing, Telecommunications. Federal Communications Commission. Marlene H. Dortch, Secretary. Final Rules For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 1 as follows: PART 1—PRACTICE AND PROCEDURE For the reasons discussed in the preamble, the FCC amends part 1 of the Code of Federal Regulations to read as follows: 1. The authority citation for part 1 continues to read as follows: Authority: 15 U.S.C. 79 et seq. ; 47 U.S.C. 151, 154(i), 154(j), 155, 157, 225, 303(r), and 309. 2. Revise paragraphs (a), (b) introductory text, (d)(2)(i) introductory text, (d)(2)(ii) and by adding paragraph (d)(2)(iii) to § 1.2111 to read as follows: § 1.2111 Assignment or transfer of control: unjust enrichment. (a) Reporting requirement. An applicant seeking approval for a transfer of control or assignment (otherwise permitted under the Commission's rules) of a license within three years of receiving a new license through a competitive bidding procedure must, together with its application for transfer of control or assignment, file with the Commission a statement indicating that its license was obtained through competitive bidding. Such applicant must also file with the Commission the associated contracts for sale, option agreements, management agreements, or other documents disclosing the local consideration that the applicant would receive in return for the transfer or assignment of its license (see § 1.948). This information should include not only a monetary purchase price, but also any future, contingent, in-kind, or other consideration ( e.g. , management or consulting contracts either with or without an option to purchase; below market financing). (b) Unjust enrichment payment: set-aside. As specified in this paragraph an applicant seeking approval for a transfer of control or assignment (otherwise permitted under the Commission's rules) of, or for entry into a material relationship (see §§ 1.2110, 1.2114) (otherwise permitted under the Commission's rules) involving, a license acquired by the applicant pursuant to a set-aside for eligible designated entities under § 1.2110(c), or which proposes to take any other action relating to ownership or control that will result in loss of eligibility as a designated entity, must seek Commission approval and may be required to make an unjust enrichment payment (Payment) to the Commission by cashier's check or wire transfer before consent will be granted. The Payment will be based upon a schedule that will take account of the term of the license, any applicable construction benchmarks, and the estimated value of the set-aside benefit, which will be calculated as the difference between the amount paid by the designated entity for the license and the value of comparable non-set-aside license in the free market at the time of the auction. The Commission will establish the amount of the Payment and the burden will be on the applicants to disprove this amount. No Payment will be required if: (d) * * * (2) * * * (i) For licenses initially granted after April 25, 2006, the amount of payments made pursuant to paragraph (d)(1) of this section will be 100 percent of the value of the bidding credit prior to the filing of the notification informing the Commission that the construction requirements applicable at the end of the initial license term have been met. If the notification informing the Commission that the construction requirements applicable at the end of the initial license term have been met, the amount of the payments will be reduced over time as follows: (ii) For licenses initially granted before April 25, 2006, the amount of payments made pursuant to paragraph (d)(1) of this section will be reduced over time as follows: (A) A transfer in the first two years of the license term will result in a forfeiture of 100 percent of the value of the bidding credit (or in the case of very small businesses transferring to small businesses, 100 percent of the difference between the bidding credit received by the former and the bidding credit for which the latter is eligible); (B) A transfer in year 3 of the license term will result in a forfeiture of 75 percent of the value of the bidding credit; (C) A transfer in year 4 of the license term will result in a forfeiture of 50 percent of the value of the bidding credit; (D) A transfer in year 5 of the license term will result in a forfeiture of 25 percent of the value of the bidding credit; and (E) For a transfer in year 6 or thereafter, there will be no payment. (iii) These payments will have to be paid to the United States Treasury as a condition of approval of the assignment, transfer, ownership change, or reportable eligibility event (see § 1.2114). 3. Revise paragraph (a)(1) of § 1.2114 to read as follows: § 1.2114 Reporting of Eligibility Event. (a) * * * (1) Any spectrum lease (as defined in § 1.9003) or resale arrangement (including wholesale agreements) with one entity or on a cumulative basis that might cause a licensee to lose eligibility for installment payments, a set-aside license, or a bidding credit (or for a particular level of bidding credit) under § 1.2110 and applicable service-specific rules. [FR Doc. E6-9275 Filed 6-13-06; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 06-1073] Radio Broadcasting Services; Columbia, MO AGENCY: Federal Communications Commission. ACTION: Final rule; denial of petition for reconsideration. SUMMARY: This document denies a Petition for Reconsideration filed by The Curators of the University of Missouri directed at a staff letter action in this proceeding, which dismissed the Petition for Rulemaking requesting the reservation of vacant FM Channel 252C2 at Columbia, Missouri for noncommercial educational use. With this action, the proceeding is terminated. FOR FURTHER INFORMATION CONTACT: Rolanda F. Smith, Media Bureau (202) 418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's Memorandum Opinion and Order , adopted May 24, 2006, and released May 26, 2006. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals 2, CY-A257, 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20054, telephone 1-800-378-3160 or http://www/BCPIWEB.com . The Commission will not send a copy of this Memorandum Opinion and Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the aforementioned petition for reconsideration was denied. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. 06-5227 Filed 6-13-06; 8:45 am]

Supplementary Information

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. It simply announces the submission of a draft final rule to the United States Department of Agriculture (USDA) and does not otherwise affect any specific entities. This action may, however, be of particular interest to those persons who register pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) or who use pesticides. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the this action, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? 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 Action is EPA Taking? Section 25(a)(2) of FIFRA requires the Administrator to provide the Secretary of Agriculture with a copy of any final regulation at least 30 days before signing it for publication in the Federal Register . The draft final rule is not available to the public until after it has been signed by EPA. If the Secretary comments in writing regarding the draft final rule within 15 days after receiving it, the Administrator shall include the comments of the Secretary, if requested by the Secretary, and the Administrator's response to those comments in the final rule when published in the Federal Register . If the Secretary does not comment in writing within 15 days after receiving the draft final rule, the Administrator may sign the final rule for publication in the Federal Register anytime after the 15-day period. III. Do Any Statutory and Executive Order Reviews Apply to this Notification? No. This document is not a rule, it is merely a notification of submission to the Secretary of Agriculture. As such, none of the regulatory assessment requirements apply to this document. IV. Will this Notification be Subject to the Congressional Review Act? No. This action is not a rule for purposes of the Congressional Review Act (CRA), 5 U.S.C. 804(3), and will not be submitted to Congress and the Comptroller General. EPA will submit the final rule to Congress and the Comptroller General as required by the CRA. List of Subjects in Part 155 Environmental protection, Administrative practice and procedure, Pesticides and pests Dated: June 2, 2006. James Jones, Director, Office of Pesticide Programs. [FR Doc. E6-9077 Filed 6-13-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0303; FRL-8072-3] Bacillus mycoides isolate J; Temporary Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the microbial pesticide Bacillus mycoides isolate J on sugar beets when applied/used to control Cercospora Leaf Spot ( Cercospora beticola ) in sugar beets. Montana Microbial Products submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting the temporary exemption from tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus mycoides isolate J. The temporary tolerance exemption will expire on December 31, 2007.*