2010-27636. Approval and Promulgation of Air Quality Implementation Plans; Illinois; Volatile Organic Compound Site-Specific State Implementation Plan for Abbott Laboratories

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is approving into the Illinois State Implementation Plan (SIP) amendments to Illinois' manufacturing rules. On July 17, 2009, the Illinois Environmental Protection Agency (Illinois EPA) submitted amendments to its pharmaceutical manufacturing rules for approval into its SIP. These amendments consist of a site-specific rulemaking for certain of Abbott Laboratories' (Abbott) tunnel dryers and fluid bed dryers. This site-specific rule revision is approvable because it lowers the allowable emissions from these dryers and it is consistent with the Clean Air Act (CAA) and EPA regulations. EPA proposed these rules for approval on July 14, 2010, and received no comments.

DATES:

This final rule is effective on December 3, 2010.

ADDRESSES:

EPA has established a docket for this action under Docket ID Nos. EPA-R05-OAR-2009-0665. 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., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. We recommend that you telephone Steven Rosenthal, Environmental Engineer, at [phone] before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT:

Steven Rosenthal, Environmental Engineer, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, [phone].

SUPPLEMENTARY INFORMATION:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

I. What public comments were received on the proposed approval and what is EPA's response?

II. What action is EPA taking today and what is the purpose of this action?

III. Statutory and Executive Order Reviews.

I. What public comments were received on the proposed approval and what is EPA's response?

EPA's July 14, 2010, proposed action at 75 FR 40760 provided a 30-day public comment period. We did not receive any comments on the proposed action.

II. What action is EPA taking today and what is the purpose of this action?

EPA is approving revisions to Illinois' pharmaceutical manufacturing rule for three of Abbott's fluid bed dryers and four of its tunnel dryers. Specifically, EPA is approving amendments to 35 Ill. Adm. Code 218.480 adopted August 21, 2008, and effective August 26, 2008. Each of the three fluid bed dryers previously had a five tons volatile organic compound (VOC) per year applicability cutoff and each of the four tunnel dryers had a 7.5 tons VOC per year applicability cutoff. This rule revision replaces these individual cutoffs with an overall combined cutoff for all seven dryers of 20.6 tons VOC per year.

In EPA's July 14, 2010, proposal (75 FR 40760), we present a detailed legal and technical analysis of the State's submission. The reader is referred to that notice for additional background on the submission and the bases for EPA's approval.

III. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 CAA. 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 Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 3, 2011. 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: October 1, 2010.

Susan Hedman,

Regional Administrator, Region 5.

40 CFR part 52 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 O—Illinois

2. Section 52.720 is amended by adding paragraph (c)(186), to read as follows:

§ 52.720

Identification of plan.

* * * * *

(c) * * *

(186) On July 17, 2009, Illinois submitted amendments to its pharmaceutical manufacturing rules for approval into its state implementation plan. These amendments consist of a site-specific rulemaking for certain of Abbott Laboratories' (Abbott) tunnel dryers and fluid bed dryers.

(i) Incorporation by reference.

(A) Illinois Administrative Code, Title 35: Environmental Protection, Subtitle B: Air Pollution, Chapter I: Pollution Control Board, Subchapter c: Emission Standards and Limitations for Stationary Sources, Part 218: Organic Material Emission Standards and Limitations for the Chicago Area, Subpart T: Pharmaceutical Manufacturing, Section: 218.480 Applicability, effective August 26, 2008.

(ii) Additional material.

(A) Letter from Laurel L. Kroack, Illinois Environmental Protection Agency, to Cheryl Newton, EPA, dated May 12, 2010, with attachments, that establishes how compliance with Abbott's 20.6 tons VOC per year limit is determined as well as Abbott's recordkeeping requirements.