(SEE PERSONS ON ATTACHED LIST)
CERTIFICATE OF SERVICE

EECEIVED

LEAK S OFFICE

BEFORE THE ILLiNOIS POLLUTION CONTROL BOARD

MAR

(12005

WALLACE PHARMACEUTICALS,

)

P~t~

f~d

Petitioner,

)

PCB 02-207

)

(Air—Variance)

ILLINOIS ENVIRONMENTAL

)

PROTECTION AGENCY,

)

Respondent.

)

NOTICE OF

FILING

TO:

Ms. Dorothy M. Gunn

Clerk ofthe Board

Illinois Pollution Control Board

100 West Randolph Street

Suite 11-500

Chicago, Illinois

60601

(VIA FIRST CLASS

MAIL)

(SEE PERSONS ON ATTACHED LIST)

PLEASE TAKE NOTICE that I have today filed with the Office of the Illinois

Pollution Control Board an original and nine copies ofa JOINT

MOTION TO

WITHDRAW VARIANCE, copies ofwhich are herewith served upon you.

Respectfully submitted,

WALLACE PHARMACEUTICALS,

Petitioner,

By~Z~f1~2f1

__‘/~/

N. LaD onna~

Driver

Dated:

March

8, 2005

N. LaDonna Driver.

HODGE DWYER ZEMAN

3150

Roland

Avenue

Post Office Box

5776

Springfield, Illinois

62705-5776

(217) 523-4900

THIS

FILING SUBMITTED ON RECYCLED PAPER

CERTIFICATE OF SERVICE

I, N. LaDonna Driver, the undersigned, hereby certify that I have served the

attached JOINT MOTION TO WITHDRAW VARIANCE upon:

Ms. Dorothy M. Gunn

Clerk ofthe Board

Illinois Pollution Control Board

100 West Randolph Street

Suite 11-500

Chicago, Illinois

60601

Sally Carter, Esq.

Division of Legal Counsel

Illinois Environmental Protection Agency

1021

North Grand Avenue East

Post Office Box

19276

Springfield, Illinois

62794

by depositing said documents in the United States Mail, postage prepaid, in Springfield,

Illinois on March 8, 2005.

N. LaDonna Driver

MEDP:OO1/Fil/NOF-COS

—

Joint Motion to Withdraw

RECEJVED

CLERK’S OFFICE

BEFORE THE

ILLINOIS POLLUTION CONTROL BOARD

MAR

102005

WALLACE PHARMACEUTICALS,

)

STATE OF ILLINOIS

)

Pollution Control

Board

Petitioner,

)

PCB

No.

02-207

)

(Variance-Air)

ILLINOIS ENVIRONMENTAL

)

PROTECTION AGENCY,

)

Respondent.

)

JOINT MOTION TO WITHDRAW VARIANCE

The

Illinois

Environmental Protection

Agency (“Illinois EPA”) and

MedPointe

Pharmaceuticals,

formerly Wallace

Pharmaceuticals,

(“MedPointe”) hereby submit this

Joint Motion to Withdraw Variance in the above captioned matter

pursuant to 35

Ill. Adm.

Code 101.500.

The Illinois

EPA and

MedPointe respectfully request that the Board

Withdraw the Variance granted toMedPointe on September 19, 2002.. In support of this

Motion, the Illinois

EPA and

MedPointe state as follows:

MedPointe filed its Petition

for Variance (“Petition”) on or about May

17,

2002.

The Petition

requested that the Board grant MedPointe a variance for five dryers

in the pharmaceutical tablet manufacturing

process from the volatile Organic material

(VOM) emission control requirements

of 35

Ill. Adm.

Code 215.482(a).

Under the

applicable regulations,

if the drying process exceeds the applicable threshold

at 35

III.

Adm.

Code 21 5.480(a), VOM emissions are

regulated

under 215.482(a).

Section

21 5.480(a) regulates VOM emission sources

at pharmaceutical manufacturing

plants

whose,emissions exceed

lbs./day and

2.5 tons/year, or whose emissions

are less

than 2.5 tons/year but more than

100 lbs./day.

Section 215.482(a) requires

at least 90

reduction in

VOM emissions from each unit.

See,

Board Order,

September 19,

2002.

The Petition asserted that the plant sought to shut down its tablet

operation for a 10-12 week period

in the second

half of 2002 to perform

plant

improvements.

Prior to the shutdown, the plant would have

produce an additional

weeks of inventory.

In addition,

MedPointe anticipated

a production

and emission

increase

2002 due to the 2001

introduction of two new

products and

an anticipated

introduction of a third

new product.

The Petitioner alleged that these changes would..

cause VOM emissions in

excess of the thresholds in

Section 215.480(a).

or about

June 24, 2002,

the Illinois

EPA filed a response recommending that

the Board grant the

variance subject

to certain

conditions..

In the Board’s September

19, 2002,

Order (“Order”), the Board granted

MedPointe’s

Petition.

the Order, the Board allowed the variance subject

to the

following conditions:.

The petitioner must begin

preliminary research on the search for a non-

VOM solvent or process modification immediately and finish

such

research by June

1, 2003.

Petitioner must notify the Illinois

EPA of such

results.

The petitioner must begin the add-on

control technology assessment,

well as the bench-top evaluation of non-VOM solvents or process

modifications selected from preliminary research by June

2003.

Wallace must complete the assessment of suitable add-on

control

technology and the bench-top evaluation of non-VOM

solvents or process

modification by April

2004.

Petitioner must notify the

Illinois EPA of

such results.

Should the bench-top evaluations prove successful for one or more non-

VOM

solvents or process modifications,

petitioner must proceed to.pilot

scale testing

by April

2004, with

completion by February

2005.

Petitioner must notify the Illinois EPA of such results.

If the pilot scale

technology proves successful, petitioner must proceed to full scale

manufacturing evaluation and stability testing which will

be completed by

December

2005.

Petitioner must notify the Agency of such

results.

this phase of process development is successful, full implementation of

the chosen

option must be completed

by December

1, 2006.

At three points throughout the testing

process Wallace must evaluate the

success of its attempts

find a non-VOM solvent or process

modification.

These three points must be at the conclusion of bench-top

testing,

pilot testing and

manufacturing

and stability testing.

At each

point,

if the tests have been

unsuccessful, Wallace must proceed with

either the search for suitable add-on control technology,

file a petition for

a site-specific rulemaking

or choose to

operate below the Subpart T VOM

emission threshold.

If add-on

control technology is to

be installed, the necessary structural

engineering evaluations for add-on

control technology,

and the design of

the control systems

be completed within 4 months from the date that the

Petitioner determines that

add-on control technology will be

utilized.

application for a construction permit must be submitted to the Illinois

EPA

within

a month.

Control equipment shall then be ordered one month after

issuance of the construction permit and

must be delivered and

installed

within

additional four months.

The control system

must be started up,

go through shake down, and

be operating satisfactorily

no longer than

two months from this point.

Final

compliance must be reported to the

Agency no

later than

December 31, 2006.

If the control technology assessment

reveals that there is no reasonably

available control technology for the VOM emissions from the dryers, the

petitioner must report this in the next scheduled report, as listed

below.

Petitioner must then confer the

Illinois

EPA about whether they will seek a

site-specific rule to increase Subpart T control thresholds for the Decatur

facility.

In the alternative,

the petitioner may choose to operate below the

Subpart T control threshold.

Petitioner must provide semi-annual reports

indicating progress

made

towards the development of a suitable alternative

to usage of ethanol in

their process, and the development of a suitable add-on control

technology device to achieve

compliance with 35

III. Adm.

Code 215,

Subpart T, acbording to the compliance plan contained

herein.

Petitioner’s progress reports must be filed as follows:

4/30/03

for the period

9/1/02

3/31/03

10/30/03

for the period

4/1/03

9/30/03

4/30/04

for the period

10/1/03

3/31/04

10/30/04

for the period

4/1/04

9/30/04

4/30/05

for the period

10/1/04

3/31/05

10/30/05

for the period

4/1/05

9/30/05

4/30/06

for the period

9/1/05

3/31/06

10/30/06

for the period

4/1/06

9/30/06

unless compliance is achieved prior to the reports date.

Each of the five dryers at the Wallace facility

is to

be limited to 5.0

tons/year of VOM emissions.

The Ross dryers is limited to VOM

emissions of 100 lbs./day while the Lydon dryer

is limited to

280 lbs/day.

Deôember 14, 2004, MedPointe

representatives met with

Illinois

EPA

representatives

to discuss

its statusunder Section 215.480(a) and the September

19,

2002, variance.

the meeting,

Med Pointe indicated that the products that involved

the

use

of VOM, that were the subject of the variance, have

all but ceased production.

Production at the facility has

instead shifted

to different

products using processes that do

not involve VOM.

Based

on this shift

in its operations, MedPointe represented that

it has

been emitting VOM far below the thresholds in

III. Adm.

Code

215.480(a),

for the

duration of the variance to date.

its annual

emission report for 2002,

Med Pointe

reported plant-wide VOM emissions of 6.87 ton/year.

its 2003 annual emission

report,

MedPointe

reported plant-wide VOM

emissions of 1.22

ton/year.

This is well below

Subpart T’s VOM

emission threshold

of 12.5 ton/year (2.5 ton/year x 5 dryers).

MedPointe

expects this situation to

continue for the foreseeable future.

The Order does not provide clear guidance on the current factual

scenario,.where Med Pointe

represents that the production

at issue

in the variance has

virtually ceased.

Paragraph

3(h) of the Board’s Order provides that progress reports

must

be filed

by certain identified

dates unless compliance is achieved

prior to the

report due date.

While MedPointe has been filing semi-annual

reports under the

schedule

in the Board’s Order, Med Pointe’s reported emissions have

been

below the

VOM emission threshold of 12.5 ton/year;

thus, progress

reports are arguably not

required by the Board’ s Order.

However,

due to the requirements of

paragraphs 3(a)

through 3(f) of the Board’s Order concerning the continuing evaluation and testing of

add-on

control technology and the evaluation and testing

of the use of non-VOM

solvents, the parties consulted on the best course of action.

After consultation between

the Illinois

EPA and MedPointe, the parties believe

that the variance should simply be

withdrawn.

Due to

the petitioner’s reported emission

below the VOM emission

threshold

of 12.5 tons/year, the withdrawal of the variance will have

no impact on Macon

County’s attainment status and,

if anything, will benefit the environment by eliminating

the previously allowed increase in daily and annual VOM emissions from the facility.

WHEREFORE, the Illinois

EPA and

MedPointe jointly request that the Board

withdraw MedPointe’s Variance.

Respectfully submitted,

MEDPOINTE

PHARMACEUTICALS,

LaDonna Driver

Attorney

MedPointe

Pharmaceuticals

Hodge Dwyer Zeman

3150 Roland Avenue

Post

Office Box 5776

Springfield,

IL 62705-5776

217/523-4900

ILLINOIS

ENVIRONMENTAL

PROTECTION AGENCY,

Sally Ca~r

Assistant Counsel

Special Assistant Attorney General

Division of Legal

Counsel

Illinois Environmental Protection Agency

1021

North Grand Avenue East

P.O.

Box 19276

Springfield,

62794-9276

217/782-5544