[Federal Register Volume 69, Number 215 (Monday, November 8, 2004)]
[Rules and Regulations]
[Pages 64661-64664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24821]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[R05-OAR-2004-IN-0004; FRL-7820-4]


Approval and Promulgation of Implementation Plans; Indiana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The EPA is approving revisions to volatile organic compound 
(VOC) requirements for Eli Lilly and Company (Eli Lilly) for a facility 
which it owns and operates in Marion County, Indiana. On February 11, 
2004, the Indiana Department of Environmental Management (IDEM) 
submitted a Commissioner's Order requesting the revision as an 
amendment to the Indiana State Implementation Plan (SIP). The February 
11, 2004 submission supplements a December 19, 2001 submission.
    Eli Lilly owns and operates a synthesized pharmaceutical 
manufacturing facility in Marion County. This SIP revision covers new 
and existing sources in Eli Lilly's Building 110 pilot plant. Eli Lilly 
is seeking an exemption from 326 Indiana Administrative Code (IAC) 8-5-
3, control requirements for synthesized pharmaceutical manufacturing, 
under the site-specific reasonably available control technology (RACT) 
rule, 326 IAC 8-1-5. Eli Lilly is seeking this exemption for reactors, 
filters, centrifuges, and vacuum dryers at Building 110. Other Building 
110 sources, such as air dryers, in-process tanks, and storage tanks, 
comply with 326 IAC 8-5-3. The total VOC annual emissions from Building 
110 are limited to less than 10 tons per year (TPY).

DATES: This rule is effective on January 7, 2005, unless the EPA 
receives relevant adverse written comments by December 8, 2004. If 
adverse comment is received, the EPA will publish a timely withdrawal 
of the rule in the Federal Register and inform the public that the rule 
will not take effect.

ADDRESSES: Submit comments, identified by Docket ID No. R05-OAR-2004-
IN-0004 by one of the following methods: Federal eRulemaking Portal: 
http://www.regulations.gov. Follow the on-line instructions for 
submitting comments.
    E-mail: [email protected].
    Fax: (312) 886-5824.
    Mail: You may send written comments to: J. Elmer Bortzer, Chief, 
Air Programs Branch, (AR-18J), Environmental Protection Agency, 77 West 
Jackson Boulevard, Chicago, Illinois 60604.
    Hand delivery: Deliver your comments to: J. Elmer Bortzer, Chief, 
Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 
Region 5, 77 West Jackson Boulevard, 18th floor, Chicago, Illinois 
60604.
    Such deliveries are only accepted during the Regional Office's 
normal hours of operation. The Regional Office's 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. R05-AR-2004-N-
0004. EPA's policy is that all comments received will be included in 
the public docket without change, 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 regulations.gov, or 
e-mail. The Federal 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 
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, 
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 the related proposed rule which is 
published in the Proposed Rules section of this Federal Register.
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket. 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. Publicly available docket materials are available either 
electronically in EDOCKET or in hard copy at Environmental Protection

[[Page 64662]]

Agency, Region 5, Air and Radiation Division, 77 West Jackson 
Boulevard, Chicago, Illinois 60604. (We recommend that you telephone 
Matt Rau, Environmental Engineer, at (312) 886-6524 before visiting the 
Region 5 office.) This Facility is open from 8:30 a.m. to 4:30 p.m., 
Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Matt Rau, Environmental Engineer, 
Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. 
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, 
Chicago, Illinois 60604, Telephone: (312) 886-6524, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,'' 
``us,'' or ``our'' are used we mean the EPA.

Table of Contents

I. General Information
II. What Is EPA approving?
III. What are the changes from the current rule?
IV. What is the EPA's analysis of the supporting materials?
V. What are the environmental effects of these actions?
VI. What rulemaking actions is the EPA taking?
VII. Statutory and Executive Order Reviews.

I. General Information

A. How Can I Get Copies of This Document and Other Related Information?

    1. The Regional Office has established an electronic public 
rulemaking file available for inspection on EDOCKET and a hard copy 
file which is available for inspection at the Regional Office. EPA has 
established an official public rulemaking file for this action under 
Docket ID No. R05-AR-2004-IN-0004. The official public file consists of 
the documents specifically referenced in this action, any public 
comments received, and other information related to this action. 
Although a part of the official docket, the public rulemaking file does 
not include Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. The official 
public rulemaking file is the collection of materials that is available 
for public viewing at the Air Programs Branch, Air and Radiation 
Division, EPA Region 5, 77 West Jackson Boulevard, Chicago, Illinois 
60604. EPA requests that if at all possible, you contact the person 
listed in the FOR FURTHER INFORMATION CONTACT section to schedule your 
inspection. The Regional Office's official hours of business are Monday 
through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays.
    2. Electronic Access. You may access this Federal Register document 
electronically through the regulations.gov Web site located at http://www.regulations.gov where you can find, review, and submit comments on 
Federal rules that have been published in the Federal Register, the 
Government's legal newspaper, and are open for comment.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing at the EPA Regional Office, 
as EPA receives them and without change, unless the comment contains 
copyrighted material, CBI, or other information whose disclosure is 
restricted by statute. When EPA identifies a comment containing 
copyrighted material, EPA will provide a reference to that material in 
the version of the comment that is placed in the official public 
rulemaking file. The entire printed comment, including the copyrighted 
material, will be available at the Regional Office for public 
inspection.

B. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate rulemaking identification number by including the text 
``Public comment on proposed rulemaking Region 5 Air Docket ``R05-OAR-
2004-IN-0004'' in the subject line on the first page of your comment. 
Please ensure that your comments are submitted within the specified 
comment period. Comments received after the close of the comment period 
will be marked ``late.'' EPA is not required to consider these late 
comments.
    For detailed instructions on submitting public comments and on what 
to consider as you prepare your comments see the ADDRESSES section and 
the section I General Information of the SUPPLEMENTARY INFORMATION 
section of the related proposed rule which is published in the Proposed 
Rules section of this Federal Register.

II. What Is EPA Approving?

    EPA is approving revisions to VOC control requirements for the Eli 
Lilly pharmaceutical manufacturing facility in Marion County, Indiana. 
Indiana submitted Commissioner's Order 2003-02 on February 11, 
2004, requesting revisions as an amendment to its SIP. The February 11, 
2004 submission supplements a December 19, 2001 submission.
    Indiana is seeking an exemption from 326 IAC 8-5-3 for reactors, 
centrifuges, filters, and vacuum dryers in Building 110, the pilot 
plant for Eli Lilly. This exemption can be granted under 326 IAC 8-1-5, 
which allows site-specific RACT plans as an alternative to 326 IAC 
Article 8 requirements. Other Building 110 sources such as the air 
dryers and the storage tanks comply with 326 IAC 8-5-3.
    Indiana has determined that using primary reactor condensers 
operating at -10[deg] Celsius on the reactors is RACT. Indiana has also 
determined that no emissions controls are feasible for the vacuum 
dryers. Eli Lilly must enclose all Building 110 centrifuges and filters 
having an exposed solvent surface. The RACT control level is the 
condensers set at -10[deg]C, which meets the required control level for 
most VOCs that Eli Lilly will be using. However, some VOCs may be used 
for which 326 IAC 8-5-3 requires a lower temperature on the condensers. 
The temperature requirement is based on the vapor pressure of the 
solvent. Eli Lilly will operate its primary reactor condensers at a 
steady temperature, -10[deg]C, instead of adjusting for the vapor 
pressure of the VOC being used because of the frequent solvent changes. 
Eli Lilly is required to certify that the condensers were operating at 
all required times.
    Even with these relaxations from 326 IAC 8-5-3, the total VOC 
emissions from this facility will remain low because VOC emissions for 
Building 110 are limited to less than 10 tons per 12 consecutive months 
period rolled on a monthly basis. IDEM determines the Building 110 
emissions using the detailed batch records kept by Eli Lilly. The 
records consist of the amount of each solvent contained in each input, 
product, and waste stream for each batch operation including: New 
solvent added, solvent generated during the process reactions, solvent 
added from another batch, waste solvent generated, solvent sent to the 
sewer, solvent consumed during process reactions, solvent drummed for 
later use, and solvent collected and emitted during product drying. Eli 
Lilly measures the new and recovered solvent used, the solvent in the 
liquid waste, and the material collected from the condenser during 
drying. The amount of each solvent that is generated or consumed by the 
chemical reactions is calculated using information found in process 
notebooks that are available for inspection. The air emissions are 
obtained by a material balance

[[Page 64663]]

calculation by subtracting the measured waste solvent and dryer 
collected product and the calculated solvent consumed from the measured 
solvent added and the calculated solvent generated. Eli Lilly tallies 
the VOC emission amounts for all batches to determine the monthly VOC 
emissions from Building 110.

III. What Are the Changes From the Current Rule?

    Indiana requested VOC rule revisions for sources in Eli Lilly's 
Building 110. Eli Lilly is also now allowed to add equipment to and 
move equipment around Building 110 without the need for approval of a 
new SIP revision. Previously, Eli Lilly had listed its equipment and 
the module where it was being used. Equipment changes required a permit 
and a SIP revision. The new process simplifies the addition of new 
equipment within certain parameters, while establishing a strict 
building-wide VOC limit. Other changes include allowing the condensers 
on the reactors to maintain a steady temperature. This is a change from 
the requirements of 326 IAC 8-5-3 (b)(1)(A), which varies the condenser 
temperature based on the solvent vapor pressure.

IV. What Is the EPA's Analysis of the Supporting Materials?

    Indiana has submitted Technical Support Documents in support of the 
requested SIP revision. It has also provided a listing of the solvents 
used in the reactors. The two technically feasible control techniques 
for Eli Lilly to meet the 326 IAC 8-5-3 requirements are absorption and 
condensation. Indiana found these to be economically infeasible for 
both absorption and for condensation at -25[deg]C, a level that ensures 
compliance with 326 IAC 8-5-3 (b)(1)(A). Indiana determined that RACT 
for Eli Lilly's pilot plant is operating condensers at -10[deg]C on the 
reactors, enclosing all centrifuges and filters, and no controls on 
vacuum dryers. Air dryers, storage tanks, and in-process tanks in 
Building 110 comply with 326 IAC 8-5-3.
    Indiana also replaced an equipment list for each module in the 
pilot plant as contained in a 1994 construction permit (CP 097-3341), 
with the requirement that Eli Lilly can add sources without a SIP 
revision if:
     They are part of Eli Lilly's research and development 
(R&D) process;
     They comply with the RACT plan provided in Commissioner's 
Order 2003-02, Appendix A; and,
     The total Building 110 VOC emissions remain limited to 
less than 10 TPY.
    This gives Eli Lilly more flexibility with its R&D equipment and 
eliminates the need for both Indiana and EPA to review numerous SIP 
revisions for sources with low emissions levels.
    EPA finds that these revisions can be approved. Building 110 
sources are used for R&D activities. The pharmaceutical products made 
there are used to test more efficient production processes and to 
develop new pharmaceutical products. This means there are frequent 
changes in the equipment and solvents used in production. EPA believes 
that the requested revisions are appropriate considering the operations 
occurring in Building 110 and the annual building-wide VOC limit of 
less than 10 TPY.

V. What Are the Environmental Effects of These Actions?

    Reactions involving VOCs and nitrogen oxides in warm air form 
tropospheric (ground level) ozone. The highest concentrations of ozone 
occur in the warm months of the year. Ozone decreases lung function 
causing chest pain and coughing. It can aggravate asthma and other 
respiratory diseases. Children playing outside and healthy adults who 
work or exercise outside also may be harmed by elevated ozone levels. 
Ozone also reduces vegetation growth and reproduction including 
economically important agricultural crops.
    Eli Lilly's Building 110 VOC emissions are limited to less than 10 
tons per 12 consecutive months period rolled on a monthly basis. Eli 
Lilly must keep its VOC emissions below 10 TPY, even if it adds more 
R&D equipment to Building 110. This should continue to protect the air 
quality of Marion County, Indiana. In addition, Eli Lilly remains 
subject to all applicable New Source Review requirements.

VI. What Rulemaking Actions Is the EPA Taking?

    The EPA is approving, through direct final rulemaking, revisions to 
VOC emissions regulations for the Eli Lilly pharmaceutical 
manufacturing facility in Marion County, Indiana. The revisions include 
an exemption from the control requirements of 326 IAC 8-5-3 for 
reactors, centrifuges, filters, and vacuum dryers in Building 110, the 
pilot plant. This exemption can be approved under Indiana's site-
specific RACT rule, 326 IAC 8-1-5. Eli Lilly is also authorized to add 
R&D equipment to Building 110 without additional rulemaking. Eli Lilly 
will follow the appropriate RACT plan for the new equipment and keep 
the total annual VOC limit for Building 110 to less than 10 TPY.
    We are publishing this action without a prior proposal because we 
view these as noncontroversial revisions and anticipate no adverse 
comments. However, in the ``Proposed Rules'' section of today's Federal 
Register, we are publishing a separate document that will serve as the 
proposal to approve the SIP revision if written adverse comments are 
filed. This rule will be effective on January 7, 2005 without further 
notice unless we receive relevant adverse written comment by December 
8, 2004. If the EPA receives adverse written comment, we will publish a 
final rule informing the public that this rule will not take effect. We 
will address all public comments in a subsequent final rule based on 
the proposed rule. The EPA does not intend to institute a second 
comment period on this action. Any parties interested in commenting on 
these actions must do so at this time.

VII. Statutory and Executive Order Reviews

Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and therefore is not 
subject to review by the Office of Management and Budget.

Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    For this reason, this action is also not subject to Executive Order 
13211, ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001).

Regulatory Flexibility Act

    This action merely approves State law as meeting Federal 
requirements and imposes no additional requirements beyond those 
imposed by State law. Accordingly, the Administrator certifies that 
this rule will not have a significant economic impact on a substantial 
number of small entities under the Regulatory Flexibility Act (5 U.S.C. 
601 et seq.).

Unfunded Mandates Reform Act

    Because this rule approves pre-existing requirements under state 
law and does not impose any additional enforceable duty beyond that 
required by State law, it 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).

[[Page 64664]]

Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    This rule also does not have tribal implications because it will 
not have a substantial direct effect on one or more Indian tribes, on 
the relationship between the Federal Government and Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified by Executive Order 13175 (65 
FR 67249, November 9, 2000).

Executive Order 13132: Federalism

    This action also does not have federalism implications because it 
does not have substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132 (64 FR 43255, August 
10, 1999). This action merely approves a State rule implementing a 
Federal standard, and does not alter the relationship or the 
distribution of power and responsibilities established in the Clean Air 
Act.

Executive Order 13045: Protection of Children From Environmental Health 
and Safety Risks

    This rule also is not subject to Executive Order 13045 ``Protection 
of Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997), because it is not economically significant.

National Technology Transfer Advancement Act

    In reviewing SIP submissions, EPA's role is to approve State 
choices, provided that they meet the criteria of the Clean Air Act. In 
this context, in the absence of a prior existing requirement for the 
State to use voluntary consensus standards (VCS), EPA has no authority 
to disapprove a SIP submission for failure to use VCS. It would thus be 
inconsistent with applicable law for EPA, when it reviews a SIP 
submission, to use VCS in place of a SIP submission that otherwise 
satisfies the provisions of the Clean Air Act. Thus, the requirements 
of section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (15 U.S.C. 272 note) do not apply.

Paperwork Reduction Act

    This rule does not impose an information collection burden under 
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

Congressional Review Act

    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. Section 804, however, exempts from section 801 the 
following types of rules: Rules of particular applicability; rules 
relating to agency management or personnel; and rules of agency 
organization, procedure, or practice that do not substantially affect 
the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA 
is not required to submit a rule report regarding today's action under 
section 801 because this is a rule of particular applicability.
    Under section 307(b)(1) of the Clean Air Act, petitions for 
judicial review of this action must be filed in the United StatesCourt 
of Appeals for the appropriate circuit by January 7, 2005. Filing a 
petition for reconsideration by the Administrator of this final rule 
does not affect the finality of this rule 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, Ozone, Volatile organic 
compounds.

    Dated: September 16, 2004 .
Norman Niedergang,
Acting Regional Administrator, Region 5.

0
For the reasons stated in the preamble, part 52, chapter I, title 40 of 
the Code of Federal Regulations is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart P--Indiana

0
2. Section 52.770 is amended by adding paragraph (c)(157) to read as 
follows:


Sec.  52.770  Identification of plan.

* * * * *
    (c) * * *
    (157) On December 19, 2001, and February 11, 2004, Indiana 
submitted revised volatile organic compound (VOC) emissions regulations 
for Eli Lilly and Company in Marion County. The submission provides 
alternate VOC control requirements for reactors, vacuum dryers, 
centrifuges, and filters in the pilot plant. The alternate control 
requirements are being approved under site-specific Reasonably 
Available Control Technology standards.
    (i) Incorporation by reference.
    (A) Commissioner's Order 2003-02 as issued by the Indiana 
Department of Environmental Management on February 11, 2004.
[FR Doc. 04-24821 Filed 11-5-04; 8:45 am]
BILLING CODE 6560-50-P