### 76947 Federal Register / Vol. 73, No. 244 / Thursday, December 18, 2008 / Rules and Regulations

**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS** 

■ 3. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

■ 4. In § 558.625, revise paragraphs (a), (f)(1)(vi)( c)( 1 ), (f)(1)(vi)( c)( 2), and (f)(1)(vi)( e)( 1 ) to read as follows:

**§ 558.625 Tylosin.**

(a) Specifications . Type A medicated articles containing tylosin phosphate.
* * * * *

(f) * * * (1) * * * (vi) * * * ( c) * * * ( 1 ) Indications for use . For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis

.

( 2) Limitations . Administer as tylosin phosphate in feed for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water as in § 520.2640(d)(3) of this chapter.
* * * * *

( e) * * * ( 1 ) Indications for use . For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis

. * * * * * Dated: December 10, 2008. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E8–29861 Filed 12–17–08; 8:45 am]

**BILLING CODE 4160–01–S**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Part 52**

**[EPA–R09–OAR–2008–0537; FRL–8731–3]**

**Revisions to the California State Implementation Plan, South Coast Air**  **Quality Management District**

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule.

**SUMMARY :**  EPA is finalizing approval of revisions to the South Coast Air Quality Management District portion of the California State Implementation Plan (SIP). These revisions were proposed in the Federal Register on July 24, 2008 and concern the District’s analysis of whether its rules met reasonably available control technology (RACT) under the 8-hour ozone National Ambient Air Quality Standards (NAAQS). We are approving the analysis under the Clean Air Act as amended in 1990 (CAA or the Act). **DATES :**  Effective Date: This rule is effective on January 20, 2009.

**ADDRESSES :**  EPA has established docket number EPA–R09–OAR–2008–0537 for this action. The index to the docket is available electronically at http:// www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location ( e.g., copyrighted material), and some may not be publicly available in either location ( e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the **FOR**
**FURTHER INFORMATION CONTACT** section.

**FOR FURTHER INFORMATION CONTACT :**  Stanley Tong, EPA Region IX, (415) 947–4122, tong.stanley@epa.gov.

**SUPPLEMENTARY INFORMATION :**  Throughout this document, ‘‘we,’’ ‘‘us’’ and ‘‘our’’ refer to EPA.

Table of Contents
I. Proposed Action II. Public Comments and EPA Responses III. EPA Action IV. Statutory and Executive Order Reviews I. Proposed Action

On July 24, 2007 (73 FR 43186), EPA proposed to approve the following document into the California SIP.

Local agency Document Adopted Submitted

SCAQMD .......................... Reasonably Available Control Technology Analysis ............................................... 07/14/06 01/31/07

We proposed to approve these rules because we determined that they complied with the relevant CAA requirements. Our proposed action contains more information on the submitted RACT analysis and our evaluation.

II. Public Comments and EPA Responses

EPA’s proposed action provided a 30- day public comment period. During this period, no comments were received.

III. EPA Action

No comments were submitted that change our assessment that the submitted RACT analysis complies with the relevant CAA requirements under the 8-hour ozone NAAQS. Therefore, as authorized in section 110(k)(3) of the Act, EPA is fully approving this document into the California SIP. IV. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA’s role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a ‘‘significant regulatory action’’ subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• 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);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement


### 76948 Federal Register / Vol. 73, No. 244 / Thursday, December 18, 2008 / Rules and Regulations

Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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 action 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 the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register

. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 17, 2009. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)). List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: September 24, 2008. Wayne Nastri, Regional Administrator, Region IX.

■ Part 52, 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 F—California**

■ 2. Section 52.220 is amended by adding paragraph (c)(358) to read as follows:

**§ 52.220 Identification of plan.**
* * * * *

(c) * * * (358) The 8–Hour Ozone Reasonable Available Control Technology State Implementation Plans (RACT)(SIP) for the following Air Quality Management Districts (AQMDs)/Air Pollution Control Districts (APCDs) were submitted on January 31, 2007, by the Governor’s designee.

(i) Incorporation by reference. (A) South Coast Air Quality Management District.

( 1 ) Resolution 06–24 (A Resolution of the South Coast Air Quality Management District (SCAQMD) Board certifying that the SCAQMD’s current air pollution rules and regulations fulfill the 8-hour Reasonably Available Control Technology (RACT) requirements, and adopting the RACT SIP revision, dated July 14, 2006.

( 2) South Coast Air Quality Management District (SCAQMD) Staff Report, SCAQMD 8–Hour Ozone Reasonably Available Control Technology (RACT) State Implementation Plan (SIP) Demonstration, including appendices, dated June 2006.

( 3) Notice of Exemption from the California Environmental Quality Act, SCAQMD 8–Hour Ozone Reasonably Available Control Technology (RACT) State Implementation Plan (SIP), dated June 2, 2006.

( 4 ) EPA comment letter to South Coast Air Quality Management District dated June 28, 2006, on 8-hour Ozone Reasonably Available Control Technology—State Implementation Plan (RACT SIP) Analysis, draft staff report dated May 2006, from Andrew Steckel, Chief, Rulemaking Office, U.S. EPA to Mr. Joe Cassmassi, Planning and Rules Manager, South Coast Air Quality Management District.
* * * * *
[FR Doc. E8–29641 Filed 12–17–08; 8:45 am]

**BILLING CODE 6560–50–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Parts 302 and 355**

**[EPA–HQ–SFUND–2007–0469; FRL–8753–9]**

**RIN 2050–AG37**

**CERCLA/EPCRA Administrative Reporting Exemption for Air Releases**  **of Hazardous Substances From Animal Waste at Farms** 

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule.

**SUMMARY :**  This final rule provides an administrative reporting exemption from particular notification requirements under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended. In addition, this final rule provides a limited administrative reporting exemption in certain cases from requirements under the EmergencyPlanning and Community Right-toKnow Act, also known as Title III of the Superfund Amendments and Reauthorization Act. Specifically, the administrative reporting exemption applies to releases of hazardous substances to the air that meet or exceed their reportable quantity where the source of those hazardous substances is animal waste at farms.

Nothing in this final rule changes the notification requirements if hazardous substances are released to the air from any source other than animal waste at farms ( e.g. , ammonia tanks), or if any hazardous substances from animal waste are released to any other environmental media, ( e.g. , soil, ground water, or surface water) when the release of those hazardous substances is at or above its reportable quantity. Also, the administrative reporting exemption under section 103 of the Comprehensive Environmental Response, Compensation, and Liability Act, does not limit any of the Agency’s other authorities under the Comprehensive Environmental Response, Compensation, and Liability Act sections 104 (response authorities), 106 (abatement actions), 107 (liability), or any other provisions of the Comprehensive Emergency Response, Compensation, and Liability Act or the