
[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Proposed Rules]               
[Page 40760-40762]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy10-16]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2009-0665; FRL-9175-3]

 
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: Proposed rule.

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[[Page 40761]]

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.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2009-0665, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for 
submitting comments.
    2. E-mail: bortzer.jay@epa.gov.
    3. Fax: (312) 692-2054.
    4. Mail: Jay Bortzer, Chief, Air Programs Branch (AR-18J), U.S. 
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, 
Illinois 60604.
    5. Hand Delivery: Jay Bortzer, Chief, Air Programs Branch (AR-18J), 
U.S. Environmental Protection Agency, 77 West Jackson Boulevard, 
Chicago, Illinois 60604. Such deliveries are only accepted during the 
regional office normal hours of operation, and special arrangements 
should be made for deliveries of boxed information. The Regional Office 
official hours of business are Monday through Friday, 8:30 a.m. to 4:30 
p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2009-0665. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through http://www.regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters and any form of encryption, and be free 
of any defects or viruses. For additional instructions on submitting 
comments, go to Section I of the SUPPLEMENTARY INFORMATION section of 
this document.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in 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 at (312) 
886-6052 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, (312) 886-6052.

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

[[Page 40762]]

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]
BILLING CODE 6560-50-P

