September 14, 2000

Michael Trutna

Information Transfer and Program Integration Division (MD-12)

United States Environmental Protection Agency

Research Triangle Park, North Carolina 27711

RE:	Comments of Eli Lilly and Company on Draft Guidance on Design of
Flexible Air Permits (White Paper 3)	

Dear Mr. Trutna:

Eli Lilly and Company (Lilly) is a research-based pharmaceutical
manufacturing company that discovers, develops, and produces human and
animal health medicines.  The company is based in Indianapolis, Indiana,
and has 7 research and manufacturing sites affected by the Title V
operating permit program.

As the draft of White Paper 3 correctly notes, a pharmaceutical research
or manufacturing facility needs flexibility because it utilizes
multi-purpose equipment designed to accommodate many different products.
 A typical pharmaceutical manufacturing facility will produce a number
of different products in the same equipment, or different configurations
of existing equipment – a concept called “campaigning”.  In
addition, a facility may add new equipment such as process tanks and
centrifuges, which are components of a process line.  These additions
occur in order improve process efficiency or increase production.  All
of these changes take place in an extremely competitive business where
the ability to make changes quickly is essential.

In the United States, these changes must take place against the backdrop
of numerous environmental regulations that require local, state, or
federal agencies to approve some of the changes before the company can
proceed.  Within the context of the Clean Air Act, a pharmaceutical
facility may have to address minor New Source Review (NSR), major NSR,
Title V permit revisions, and MACT general provisions’ pre-approval
processes.  All of these programs are complex and inter-related, and
each presents the potential to delay implementation of a change at a
pharmaceutical facility.

Consequently, Lilly strongly supports the concepts and suggestions set
forth in White Paper 3.  Operating permits should incorporate applicable
requirements to retain the built-in flexibility of the original
requirements.  Advance approvals will provide pharmaceutical companies
with substantially more flexibility than current rules provide –
without any negative impacts on air quality.  Lilly also agrees that
flexible permits can provide significant environmental benefits and
improve the quality of public awareness of the activities at a permitted
source.

Lilly urges EPA to finalize White Paper 3 and to provide as much support
as possible to state and local agencies that wish to develop flexible
permits for sources in their jurisdictions.  In addition to our general
support for White Paper 3, we support the more detailed comments offered
by the Pharmaceutical Research and Manufacturers Association (PhRMA).

Sincerely,

Bernie Paul

Environmental Affairs Division

Mr. Michael Trutna

September 14, 2000

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