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

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 


rwilkins on PROD1PC63 with RULES
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 Emergency 

Planning 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 


rwilkins on PROD1PC63 with RULES