Rules and Regulations. Final rule

6,485 words·~29 min read·/register/2006/06/27/06-5713

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Oxytetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application

(NADA)filed by Pfizer, Inc. The supplemental NADA revises labeling of oxytetracycline soluble powder with the current genus for the causative bacteria for American foul brood of honeybees. DATES: This rule is effective June 27, 2006. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: *joan.gotthardt@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, filed a supplement to NADA 8-622 that provides for use of TERRAMYCIN-343 (oxytetracycline HCl) Soluble Powder for treatment of various bacterial diseases of livestock. The supplemental NADA revises labeling with the current genus for the causative bacteria for American foul brood of honeybees. The supplemental NADA is approved as of May 9, 2006, and the regulations in 21 CFR 520.1660d are amended to reflect the approval. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. FDA has determined under § 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. § 520.1660d [Amended] 2. In paragraph (d)(2)(ii) of § 520.1660d, remove “ *Bacillus* ” and add in its place “ *Paenibacillus* ”. Dated: June 7, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6-10053 Filed 6-26-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF LABOR Mine Safety and Health Administration 30 CFR Part 57 RIN 1219-AB29 Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION: Final rule; corrections. SUMMARY: This document contains corrections to the final rule addressing “Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners,” and published in the **Federal Register** on Thursday, May 18, 2006 (71 FR 28924). DATES: The corrections to the preamble are effective June 27, 2006. The correction to § 57.5060(d) is effective August 16, 2006. FOR FURTHER INFORMATION CONTACT: Patricia W. Silvey, Acting Director, Office of Standards, Regulations, and Variances, MSHA, 1100 Wilson Blvd., Room 2350, Arlington, Virginia 22209-3939; 202-693-9440 (telephone); or 202-693-9441 (facsimile). This document is available on the Internet at *http://www.msha.gov/REGSINFO.HTM* . SUPPLEMENTARY INFORMATION: As published, the preamble and rule text contain errors which may be misleading and need to be corrected. Accordingly, the preamble is corrected as follows: 1. On page 28926, in the second column, in the third full paragraph, at the end of the paragraph, insert “(70 FR 55019).” 2. On page 28926, in the third column, at the end of the third line, insert “(71 FR 4331).” 3. On page 28928, in the first column, in the second paragraph, eighth line from the bottom, change “regulation” to “standard.” 4. On page 28929, in Table IV-3, under the column entitled, “Description,” in the fourth paragraph, in the last line, change “PM10” to “PM <sup>10</sup> .” 5. On page 28971, in the first column, first full paragraph, in the last line, delete the word “approach,” and replace it with the word “be.” 6. On page 29007, in the second column, in the reference for “Gavett,” in the last line, change “0124(l-3)” to “0124(1-3).” 7. On page 29007, in the third column, in the tenth line from the bottom, change “12(l-2)” to “12(1-2).” 8. On page 29008, in the first column, in the eighth line from the bottom, change “B6C3Fl” to “B6C3F1.” In addition, the rule text is corrected as follows: § 57.5060 [Corrected] 1. On page 29012, in the first column, under § 57.5060 paragraph (d), fourth line, delete the “s” from the word “exposures” so that the sentence now reads, “The mine operator must install, use, and maintain feasible engineering and administrative controls to reduce a miner's exposure to or below the applicable DPM PEL established in this section.” Dated: June 21, 2006. Patricia W. Silvey, Acting Director, Office of Standards, Regulations and Variances. [FR Doc. E6-10084 Filed 6-26-06; 8:45 am] BILLING CODE 4510-43-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD09-06-063] RIN 1625-AA00 Safety Zone; City Fireworks Celebration, Syracuse, NY AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone encompassing the navigable waters of the Syracuse Inner Harbor on the southern end of Onondaga Lake during the City Fireworks Celebration on June 30, 2006. This safety zone is necessary to ensure the safety of spectators and vessels from the hazards associated with fireworks displays. This safety zone is intended to restrict vessel traffic from a portion of Onondaga Lake, Syracuse, New York. DATES: This rule will be effective from 9:30 p.m. (local) until 10 p.m. (local) on June 30, 2006. ADDRESSES: Documents indicated in this preamble as being available in the docket, are part of docket [CGD09-06-063] and are available for inspection or copying at: U.S. Coast Guard Sector Buffalo, 1 Fuhrmann Blvd., Buffalo, New York 14203, between 8 a.m. and 4 p.m., Monday through Friday, except federal holidays. FOR FURTHER INFORMATION CONTACT: LT Tracy Wirth, U.S. Coast Guard Sector Buffalo, at

(716)843-9573. SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking

(NPRM)for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the **Federal Register** . Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event, and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event. Background and Purpose Temporary safety zones are necessary to ensure the safety of vessels and spectators from the hazards associated with fireworks displays. Based on recent accidents that have occurred in other Captain of the Port zones, and the explosive hazard of fireworks, the Captain of the Port Buffalo has determined fireworks launches in close proximity to watercraft pose significant risks to public safety and property. The likely combination of large numbers of recreational vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the locations of the launch platforms will help ensure the safety of persons and property at these events and help minimize the associated risk. The safety zone consists of all navigable waters of Onondaga Lake within a 300 foot radius of the fireworks launch site in approximate position 43°03′37″ N, 076°09′59″ W. All Geographic coordinates are North American Datum of 1983 (NAD 83). The size of this zone was determined using the National Fire Prevention Association guidelines and local knowledge concerning wind, waves, and currents. All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene representative. The Captain of the Port of Buffalo, or his designated on-scene representative, has the authority to terminate the event. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). This determination is based on the minimal time that vessels will be restricted from the zone and the zone is an area where the Coast Guard expects insignificant adverse impact to mariners from the zones' activation. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners or operators of commercial vessels intending to transit a portion of the Onondaga Lake during the activated safety zone. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone is only in effect for a very limited duration from 9:30 p.m. (local) until 10 p.m. (local) on the day of the event. Vessel traffic can safely pass outside the safety zone during the event. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding this rule so that they can better evaluate its effects and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact U.S. Coast Guard Sector Buffalo (see ADDRESSES ). Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). Collection of Information This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( *e.g.* , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969

(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This event establishes a safety zone therefore paragraph (34)(g) of the Instruction applies. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. A new temporary § 165.T09-063 is added to read as follows: § 165.T09-063 Safety Zone; City Fireworks Celebration, Syracuse, NY.

(a)*Location.* The following area is a temporary safety zone: All navigable waters of the Syracuse Inner Harbor on Onondaga Lake within a 300-foot radius of the fireworks launch site in approximate position 43°03′37″ N, 076°09′59″ W. All geographic coordinates are North American Datum of 1983 (NAD 83).

(b)*Effective time and date.* This section is effective from 9:30 p.m. (local) until 10 p.m. (local) on June 30, 2006.

(c)*Regulations.*

(1)In accordance with the general regulations in section 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Buffalo, or his designated on-scene representative.

(2)This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Buffalo or his designated on-scene representative.

(3)The “on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port to act on his behalf. The on-scene representative of the Captain of the Port will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

(4)Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port Buffalo or his on-scene representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone shall comply with all directions given to them by the Captain of the Port Buffalo or his on-scene representative. Dated: June 16, 2006. S.J. Ferguson, Captain, U.S. Coast Guard, Captain of the Port Buffalo, Sector Buffalo. [FR Doc. E6-10062 Filed 6-26-06; 8:45 am] BILLING CODE 4910-15-P LIBRARY OF CONGRESS Copyright Office 37 CFR Part 201 [Docket No. 2006-3] Notice of Termination AGENCY: Copyright Office, Library of Congress. ACTION: Final rule: technical amendment. SUMMARY: The Copyright Office is making a technical amendment in the regulation regarding notices of termination of transfers and licenses to clarify determination of the date on which notice was served. In instances where first class mail is used, the date on which notice of termination is served is the day on which the notice was mailed. DATES: *Effective Date:* June 27, 2006. FOR FURTHER INFORMATION CONTACT: Kent Dunlap, Principal Legal Advisor for the General Counsel, Telephone:

(202)707-8380. Telefax:

(202)707-8366. SUPPLEMENTARY INFORMATION: Section 201.10 of the Copyright Office's regulations establishes procedures governing the form, content, and manner of service of notices of termination of transfers and licenses under sections 203 and 304 of the copyright law, 17 U.S.C. 203, 304. Regarding service of a notice of termination, § 201.10(d)(1) of the regulations provides that service on each grantee shall be made “by personal service, or by first-class mail sent to an address which, after a reasonable investigation, is found to be the last known address of the grantee or successor in title.” In order to record a notice of termination, § 201.10(f)(ii) requires “[t]he copy submitted for recordation shall be accompanied by a statement setting forth the date on which the notice was served and the manner of service, unless such information is contained in the notice.” With respect to notices served by mail, date of service as referred to in § 201.10(f)(ii) means the day on which the notice of termination is mailed. The Documents Section of the Copyright Office has noted that a number of filings of notices of termination do not specify a single day date, but qualify the statement by saying “on or about,” or some other similar qualifier. It is our understanding that the reason some applicants avoid designating a single day date is the belief that the date of service is intended to mean the date on which the grantee receives the notice. In order to clarify this matter, we are adding a sentence at the end of § 201.10(f)(1)(ii) providing: “[i]n instances where service is made by first-class mail, the date of service shall be the day the notice of termination was deposited with the United States Postal Service.” Because this amendment is declarative of the Office's existing policy and practices and is being issued simply for purposes of clarification, the Office finds that there is good cause to make it effective immediately. List of Subjects in 37 CFR Part 201 Copyright. Technical Amendment In consideration of the foregoing, the Copyright Office is amending part 201 of 37 CFR, chapter II in the manner set forth below. PART 201—GENERAL PROVISIONS 1. The authority citation for part 201 continues to read as follows: Authority: 17 U.S.C. 702. 2. Amend § 201.10 (f)(1)(ii) by adding a sentence to the end of the paragraph to read as follows: § 201.10 Notices of termination of transfers and licenses.

(f)* * *

(1)* * *

(ii)* * * In instances where service is made by first-class mail, the date of service shall be the day the notice of termination was deposited with the United States Postal Service. Dated: June 20, 2006. Marybeth Peters, Register of Copyright. Approved by: James H. Billington, Librarian of Congress. [FR Doc. E6-10091 Filed 6-26-06; 8:45 am] BILLING CODE 1410-30-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2006-0287; FRL-8189-2] Approval and Promulgation of Implementation Plans; State of Missouri AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is approving a State Implementation Plan

(SIP)submission by the State of Missouri which revises the Construction Permits Required rule and takes no action on the revisions made to the Emissions Banking and Trading rule. A proposal was published on April 14, 2006, in the **Federal Register** , and no comments were received. As proposed, we are approving most of the revisions to the Construction Permits Required rule because the revisions incorporate, by reference, the Federal New Source Review reforms, published in the **Federal Register** on December 31, 2002. As requested by Missouri, EPA is not acting on portions of the state rule relating to Clean Unit Exemptions, Pollution Control Projects, and a portion of the record keeping provisions for the actual-to-projected-actual emissions projections test. DATES: *Effective Date:* July 27, 2006. ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-R07-OAR-2006-0287. All documents in the docket are listed on the *http://www.regulations.gov* Web site. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through *http://www.regulations.gov* or in hard copy at the Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, KS. The Regional Office's official hours of business are Monday through Friday, 8 to 4:30 excluding Federal holidays. The interested persons wanting to examine these documents should make an appointment with the office at least 24 hours in advance. FOR FURTHER INFORMATION CONTACT: Amy Algoe-Eakin at

(913)551-7942, or by e-mail at *algoe-eakin.amy@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This section provides additional information by addressing the following questions: What Is the Federal Approval Process for a SIP? What Is the Background of This Action? What Is EPA's Final Action on Missouri's Rule to Incorporate NSR Reform? What Is EPA's Final Action on Missouri's Definition of “Baseline Area”? Have the Requirements for Approval of a SIP Revision Been Met? What Action Is EPA Taking? What Is the Federal Approval Process for a SIP? In order for state regulations to be incorporated into the Federally-enforceable SIP, states must formally adopt the regulations and control strategies consistent with state and Federal requirements. This process generally includes a public notice, public hearing, public comment period, and a formal adoption by a state-authorized rulemaking body. Once a state rule, regulation, or control strategy is adopted, the state submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the final Federal action on the state submission. If adverse comments are received, they must be addressed prior to any final Federal action by us. All state regulations and supporting information approved by EPA under section 110 of the Clean Air Act (CAA or Act) are incorporated into the Federally-approved SIP. Records of such SIP actions are maintained in the Code of Federal Regulations

(CFR)at title 40, part 52, entitled “Approval and Promulgation of Implementation Plans.” The actual state regulations which are approved are not reproduced in their entirety in the CFR outright but are “incorporated by reference,” which means that we have approved a given state regulation with a specific effective date. What Is the Background of This Action? The 2002 NSR Reform rules made changes to five areas of the NSR programs. In summary, the 2002 rules:

(1)Provide a new method for determining baseline actual emissions;

(2)adopt an actual-to-projected-actual methodology for determining whether a major modification has occurred;

(3)allow major stationary sources to comply with plantwide applicability limits

(PALs)to avoid having a significant emission increase that triggers the requirements of the major NSR program;

(4)provide a new applicability provision for emissions units that are designated clean units; and

(5)exclude pollution control projects (PCPs). After the 2002 NSR Reform rules were finalized and effective, various petitioners challenged numerous aspects of the 2002 NSR Reform rules, along with portions of EPA's 1980 NSR rules (45 FR 5276, August 7, 1980). On June 24, 2005, the District of Columbia Court of Appeals issued a decision on the challenges to the 2002 NSR Reform Rules. *New York* v. *United States,* 413 F.3d (DC Cir. 2005). In summary, the Court of Appeals for the District of Columbia vacated portions of the rules pertaining to clean units and pollution control projects, remanded a portion of the rules regarding exemption from record keeping, *e.g.* , 40 CFR 52.21(r)(6) and 40 CFR 51.166(r)(6), and let stand the other provisions included as part of the 2002 NSR Reform rules. EPA has not yet responded to the Court's remand regarding record keeping provisions. In the summer of 2004, Missouri revised Missouri rule 10 CSR 10-6.060, Construction Permits Required, and Missouri rule 10 CSR 10-6.410, Emissions Banking and Trading, to incorporate the changes to the Federal NSR program. These rule revisions were adopted by the Missouri Air Conservation Commission on August 26, 2004, and became effective under state law on December 30, 2004. The rules were submitted to EPA on February 25, 2005, and the submission included comments on the rules made during the state's adoption process, the state's response to comments and other information necessary to meet EPA's completeness criteria. Because Missouri's rule revisions occurred prior to the District of Columbia Court of Appeals decision, Missouri requested in a February 28, 2006, letter that EPA not act on the PCP, Clean Unit Exemption provisions, and the reasonable possibility provision in the recordkeeping provisions for the actual-to-projected-actual emissions projections applicability test. What Is EPA's Final Action on Missouri's Rule to Incorporate NSR Reform? The final action described in this section is identical to the action we proposed in the April 14, 2006, notice of proposed rulemaking (71 FR 19467). We received no comments on any aspect of the proposal, and we are taking final action based on the rationale in the proposal and in this final rule. With the exception of the revisions affected by the Court decision, we are approving revisions to Missouri rule, 10 CSR 10-6.060, Construction Permits Required, into the SIP. This rule incorporates by reference the Federal Prevention of Significant Deterioration

(PSD)program in 40 CFR 52.21, including the 2002 NSR Reform rules described above. In relevant parts, the Missouri rule excludes the public participation requirements in § 52.21(q), in favor of the Missouri public participation process, previously approved in the SIP, in 10 CSR 10-6.060 section (12)(B). The Missouri rule retains a number of tables and appendices, which apply to the state's minor NSR program as well as the PSD program. These include provisions on innovative control technologies (Appendix E), exclusion from increment consumption (Appendix G), and air quality models (Appendix F). As we explained in the proposed rulemaking, to the extent that these provisions or similar provisions are addressed by § 52.21, the provisions of § 52.21 supersede the state provisions for purposes of the PSD program. Other provisions, such as the permit fee provisions in Appendix

(A)of 10 CSR 10-6.060, which are not addressed by § 52.21, remain in effect. Missouri's rule was adopted prior to the *New York* decision described above so it included the vacated and remanded provisions of EPA's rule. However, as mentioned previously, Missouri requested in a February 28, 2006, letter that EPA not act on the PCP and Clean Unit Exemption provisions incorporated into the state rule, and the reasonable possibility provision in the record keeping provisions for the actual-to-projected-actual emissions projections applicability test. In that letter, Missouri explained that it intended to remove the Clean Unit and PCP provisions from its rule, and that it would not apply the remanded portion of the Federal rule until EPA responds to the remand and takes final action on this portion of the Missouri rule. In the interim, all sources which use the actual-to-projected-actual applicability test authorized in the Federal rule would be required to maintain the records identified in 40 CFR 52.21(r)(6). Missouri has also clarified that the state commits to following EPA's definition of “replacement unit” and will follow EPA's clarification of how baseline emissions for PALs will be calculated (these clarifications to the EPA's rules were promulgated after the incorporation by reference date in the Missouri rule). When Missouri updates the Construction Permits Required rule, 10 CSR 10-6.060, Missouri commits to incorporating EPA's definition of “replacement unit” by reference and will include EPA's clarification of how baseline emissions for PALs are to be calculated. We are taking no action on the revision to rule 10 CSR 10-6.410, Emissions Banking and Trading, because the sole revision to this rule was a change to prevent sources from generating Early Reduction Credits

(ERCs)from PCPs that take advantage of the PCP exclusion provisions in EPA's NSR Reform rules. Since the PCP exclusion was vacated, and we are not acting on this provision, as it relates to Missouri rule 10 CSR 10-6.060, we are not acting upon the revision to Missouri rule 10 CSR 10-6.410. We also note that Missouri clarified section (9)(C)1 of the Construction Permits Required rule. Section 9 outlines Hazardous Air Pollutant permit requirements which are exempt from hazardous air pollutant permit requirements unless they are listed on the source category list established in accordance with section 112(c) of the CAA. We are taking no action on including revisions to section 9, because section 9 addresses hazardous air pollutants under section 112 and is not presently in the SIP. What Is EPA's Final Action on Missouri's Definition of “Baseline Area”? Missouri's initial NSR reform submission, which largely incorporates 40 CFR 52.21 by reference, retained the state's own definition of “baseline area,” in 10 CSR 10-6.060(1)(A)1. Additionally, Missouri requested in the February 28, 2006, letter that we approve the Construction Permits Required rule and retain Missouri's definition of baseline area in section (1)(A)1. Missouri acknowledges that the current Construction Permits Required rule does not contain the statement, “designated as attainment or classifiable under section 107(d)(1)(D) or

(E)of the Act” consistent with the federal definition of “baseline area.” We had previously approved this definition of baseline area with the specification that Missouri redesignate the areas of significant impact as the baseline area (Final rule, 47 FR 7696, and final rule, 47 FR 26833). We are approving Missouri's Construction Permits Required rule, 10 CSR 10-6.060 because Missouri has acknowledged it must make area-specific designation requests, and EPA must approve the redesignation of the area before Missouri could establish new baseline areas under its rule. Missouri also commits to revising the “baseline area” definition to clarify it will redesignate the areas of significant impact as baseline areas according to Section 107(d)(1)(D) or

(E)of the CAA. Missouri will submit these redesignations to EPA for formal approval before the new baseline area can be used for PSD permitting purposes. While Missouri works to revise the rule, Missouri commits to implementing the baseline area definition consistent with all Federal regulations and will ensure that the air quality increment analysis for permit applications complies with all Federal and state requirements. Have the Requirements for Approval of a SIP Revision Been Met? The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained below and in more detail in the technical support document that is part of this document, EPA believes that the revisions meet the substantive SIP requirements of the CAA, including section 110 and implementing regulations. What Action Is EPA Taking? We are approving most of the revisions to Missouri rule, 10 CSR 10-6.060, Construction Permits Required. Per Missouri's request, we are not acting on:

(1)Clean Unit Exemptions,

(2)Pollution Control Projects, and

(3)the “reasonable possibility” portion of the record keeping provisions for the actual-to-projected-actual emissions projections test. We are also not acting on revisions to section

(9)for Hazardous Air Pollutants in 10 CSR 10-6.060, because section 9 addresses hazardous air pollutants under section 112 and is not presently in the SIP. We are also taking no action on revisions to Missouri rule 10 CSR 10-6.410, Emissions Banking and Trading, because the only revision made to the rule involves Pollution Control Projects. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this Final action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also 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 action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that the final approvals in this final rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). The final partial disapproval will not affect any existing state requirements applicable to small entities. Federal disapproval of the state submittal does not affect its state-enforceability. Moreover, EPA's partial disapproval of the submittal does not impose a new Federal requirement. Therefore, the Administrator certifies that this final disapproval action does not have a significant impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This final rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, 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 by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have federalism implications because it does not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This final rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This final rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Dated: June 19, 2006. William W. Rice, Acting Regional Administrator, Region 7. Chapter I, Title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for Part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart AA—Missouri 2. In § 52.1320(c) the table is amended under Chapter 6 by revising the entry for “10-6.060” to read as follows: § 52.1320 Identification of plan.

(c)* * * EPA-Approved Missouri Regulations Missouri citation Title State effective date EPA approval date Explanation Missouri Department of Natural Resources * * * * * * * Chapter 6—Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of Missouri * * * * * * * 10-6.060 Construction Permits Required 12/30/2004 6/27/2006 This revision incorporates by reference elements of EPA's NSR reform rule published December 31, 2002. Provisions of the incorporated reform rule relating to the Clean Unit Exemption, Pollution Control Projects, and exemption from record keeping provisions for certain sources using the actual-to-projected-actual emissions projections test are not SIP approved. This revision also incorporates by reference the other provisions of 40 CFR 52.21 as in effect on July 1, 2003, which supersedes any conflicting provisions in the Missouri rule. Section 9, pertaining to hazardous air pollutants, is not SIP approved. * * * * * * * [FR Doc. 06-5713 Filed 6-26-06; 8:45 am]

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