Proposed Rules. Proposed rule

Agency: Environmental Protection Agency (EPA)
Action: Proposed rule
Citation: FR Doc. 2010-17139 · EPA-R05-OAR-2009-0665; FRL-9175-3 · 40 CFR 52

Summary

EPA is proposing to approve Illinois' amendments to its manufacturing rules into the Illinois State Implementation Plan (SIP). 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.

Dates

Comments must be received on or before August 13, 2010.

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 should I consider as I prepare my comments for EPA? II. What action is EPA proposing to take? III. What is the background for this action? IV. What is EPA's analysis of Illinois' revised pharmaceutical manufacturing rule? V. Statutory and Executive Order Reviews I. What should I consider as I prepare my comments for EPA? When submitting comments, remember to: 1. Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date, and page number). 2. Follow directions—EPA may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. 3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. 4. Describe any assumptions and provide any technical information and/or data that you used. 5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. 6. Provide specific examples to illustrate your concerns, and suggest alternatives. 7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. 8. Make sure to submit your comments by the comment period deadline identified. II. What action is EPA proposing to take? EPA is proposing to approve revisions to Illinois' pharmaceutical manufacturing rule for three of Abbott's fluid bed dryers and four of its tunnel dryers. 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. III. What is the background for this action? This rule revision was requested by Abbott to provide it with more manufacturing flexibility. Abbott owns a pharmaceutical manufacturing facility located in Lake County, Illinois. Abbott's operations are subject to the emission standards for VOCs at 35 Ill. Adm. Code, Subpart T—Pharmaceutical Manufacturing (Subpart T rules). Section 218.480(b) contains certain exemptions that are only applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas. This rule revision amends these site-specific exemptions by capping and lowering the overall emissions allowable under the exemptions from its tunnel dryers numbered #1, #2, #3, and #4, and fluid bed dryers numbered #1, #2, and #3. This amendment reduces combined cutoffs for these seven dryers while increasing Abbott's operational flexibility, by allowing it to make preferential use of the more efficient fluid bed dryers. IV. What is EPA's analysis of Illinois' revised pharmaceutical manufacturing rule? The revisions to Illinois' pharmaceutical manufacturing rule are approvable because it lowers the total allowable emissions from seven dryers and is consistent with the CAA, EPA regulations, and relevant policy. More specifically, the individual applicability cutoffs for the seven affected dryers results in a combined allowable emission total of 45 tons of VOC per year. The 45 tons VOC per year is based on a 5 tons VOC cutoff (in prior subsection 218.480(b)(2)) for each of the three fluid bed dryers and a 7.5 tons VOC per year cutoff (in prior subsection 218.480 (b)(3) for each of the four tunnel dryers. This compares with a 20.6 tons VOC per year total in new subsection 218.480(b)(4) for tunnel dryers numbered #1, #2, #3, and #4, and fluid bed dryers numbered #1, #2, and #3. Subsection 218.480(b)(4) replaces subsections 218.480(b)(2) and 218.480(b)(3) for these seven dryers. The main basis for evaluating this proposal is EPA's January 2001 policy on Economic Incentive Programs (EIP), which is EPA's applicable policy for evaluating emission averaging plans, also referred to as “bubbles.” Under the EIP policy, a combined emission limit is based on the lower of actual or allowable emissions. Actual emissions are based on the highest consecutive two-year period during the preceding ten-year period, which in this case is 1999-2000. The average annual actual emissions for the seven dryers during this two-year period was calculated to be 22.9 tons VOC per year. The EIP policy also requires reducing this annual emission average by ten percent to establish an environmental benefit. This results in a combined emission limit of 20.6 tons VOC per year, which is the value in the new subsection 218.480(b)(4). Illinois amended its July 17, 2009, SIP submittal in a May 12, 2010, letter and attachments from Laurel L. Kroack, Chief, Bureau of Air, Illinois Environmental Protection Agency, to EPA. This letter establishes how compliance with Abbott's 20.6 tons VOC per year limit is determined as well as Abbott's recordkeeping requirements. Specifically, this letter states: It is the Illinois EPA's interpretation that compliance with Abbott's 20.6 tons VOC per year limit shall be determined on a monthly basis from the sum of the data for the current month plus the preceding 11 months (running 12 month total) consistent with Condition 7.1.6(i) of Abbott's current Title V permit #96010010, issued on September 26, 2007. Compliance will be demonstrated according to the compliance calculation methodology and corresponding recordkeeping procedures in Katherine Hodge's April 23, 2008 email to EPA, including both the body of the email and its attachments, as well as the compliance procedures in Condition 7.1.12(e) of Abbott's current Title V permit. Also, Abbott's recordkeeping requirements should also be consistent with the recordkeeping requirements reflected in Katherine Hodge's April 23, 2008 email, including both the body of the e-mail and its attachments. These records would need to be maintained for five years. V. 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. List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: June 30, 2010. Walter W. Kovalick Jr., Acting Regional Administrator, Region 5. [FR Doc. 2010-17139 Filed 7-13-10; 8:45 am]