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ticc7I.s~
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October 26, 2004
CLERK’S
~
OCT 29
2004
Charles E. Matoesian
STATE
OF
ILL~4O~S
DolIuttOfl
Control
Boar
Division ofLegal Counsel
Illinois Environmental Protection Agency
1021
North Grand Avenue East
P0 Box 19276
Spnngfield, Illinois 62794
Re:
Wallace v. IEPA, PCB
02-207 (Air Variance)
Dear Mr. Matoesian,
As per condition 3.h. of the Order granting a variance in the above
referenced matter, MedPointe Healthcare, Inc.
is submitting this letter as a
progress report for the period from April
1, 2004 through September 30,
2004.
As noted previously, the Wallace Pharmaceuticals’ name has been
changed to MedPointe Pharmaceuticals.
According to the Order, MedPointe is required to report on the progress of
the development of a suitable alternative to the usage ofethanol in the
affected processes.
We are pleased to report that research and development
ofdirect-compression manufacturing processes has been successful, and do
not involve the use ofethanol.
These research efforts should satisf~’
conditions 3.a., 3.b., and 3.c. ofthe Order, in that the bench-top, pilot, and
commercial scale processes were successful for these products, and do not
utilize VOM solvents.
We continue our research efforts with emphasis being placed on non-VOM
products and processes for our future product development.
All new
pro(:Lucts introduced, or in development, since the effective date ofthe
variance, have involved the use ofdirect compression or other non-VOM
processes.
At this writing, we do not expect that add-on control technology
will be necessary to achieve compliance with our pre-variance limits of 12.5
tons per year.
At this writing, we expect our VOM emissions to be well below both the
allowable variance limit of 25 tons per year, and our pre-variance limit of
434
North
Morgan
Street, Decatur, IL 62523-1125
217-424-8400
www.medpointepharma.com
tons per year.
Our VOM emissions for 2003
were indeed well below
that level.
As a result ofour successful process developments, combined with our
current product portfolio which is primarily manufactured with non-VOM
processes, we will be
scheduling a meeting in the near future with you to
discuss the process ofwithdrawing this variance.
I trust this brief letter report satisfies the Order requirement for a progress
report. If any additional information is required please advise.
Sincerely,
William J. Taraszewski, Ph.D.
Director, Pharmaceutical Production
cc:
Dorothy
Gunn,
Clerk
Illinois
Pollution
Control
Board
State
of
Illinois
Center
IOU
West
Randolph
St..,
Suite
11-500
Chicago,
IL
60601
bc:.
Mr.
Paul Edick
Mr.
Will Robinson
Ms.
Beth
Hecht
Ms.
LaDonna
Drive
Mr.
Rick Majos