ILLINOIS POLLUTION CONTROL BOARD

April 7, 2005

 

WALLACE PHARMACEUTICALS

(n/k/a MEDPOINTE

PHARMACEUTICALS),

 

Petitioner,

 

v.

 

ILLINOIS ENVIRONMENTAL

PROTECTION AGENCY,

 

Respondent.

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PCB 02-207

(Variance - Air)

 

SUPPLEMENTAL OPINION AND ORDER OF THE BOARD (by J.P. Novak):

 

The Board today terminates, at the parties’ request, a September 19, 2002 variance from

the volatile organic material (VOM) emission control requirements of 35 Ill. Adm. Code

215.482(a). The variance was granted subject to conditions, and is not by its terms due to expire

until December 31, 2006. Wallace Pharmaceuticals v. IEPA, PCB 02-207 (Sept. 19, 2002).

 

On March 10, 2005, the Illinois Environmental Protection Agency (Agency) and

petitioner, Wallace Pharmaceuticals, now known as MedPointe Pharmaceuticals, and

(MedPointe), filed a “joint motion to withdraw variance” (Motion). The parties report that the

variance is no longer necessary, and that MedPointe wishes relief from the conditions contained

in the variance.

 

THE VARIANCE

 

The following summary of MedPointe’s process is drawn from the Board’s opinion and

order granting the variance. MedPointe manufactures pharmaceutical tablets at its facility in

Decatur, Macon County. During Wallace’s production process, several of the tablet products use

a wet granulation process. Two forms of wetting agents are used, water and the VOM at issue

here: denatured ethanol. When ethanol is used as the wetting agent, it is evaporated during the

drying cycle, resulting in VOM emissions from the dryers. MedPointe used five dryers in this

process. In its May 2002 petition, MedPointe stated that it planned to increase production in

October 2002, which would make its five dryers newly-subject to increased VOM control

requirements. Wallace, PCB 02-207, slip op. at 1-2.

 

MedPointe’s VOM emissions would be regulated under 35 Ill. Adm. Code 215.482(a) if

MedPointe’s drying process exceeds the applicable thresholds of Section 215.480(a). Section

215.480(a) regulates VOM emission sources at pharmaceutical manufacturing plants whose

emissions exceed 15 lbs./day and 2.5 tons/year or whose emissions are less than 2.5 tons per year

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(tpy) but more than 100 lbs. per day. 35 Ill. Adm. Code 215.480(a). Section 215.482(a) requires

at least 90% reduction in VOM emissions from each unit. 35 Ill. Adm. Code 215.482(a).

 

MedPointe expected the accelerated production and increased demand from three new

product lines beginning in October 2002 to cause the facility to exceed the thresholds of Section

215.480(a) and become subject to the Section 215.482(a) control requirements. MedPointe

requested the variance to allow it sufficient time to evaluate and implement potential options for

controlling VOM emissions from its dryers. During the variance period, MedPointe proposed to

comply with suggested alternate VOM emission limits of 5 tpy of VOM per dryer, or up to a

total of 25 tpy. Wallace, PCB 02-207, slip op. at 2-3.

 

The Agency recommended granting the variance. Environmental impact was not

expected to be substantial in an area where there had been no exceedences of the ozone standard

for the previous three reporting years. Without relief, the Agency argued, MedPointe would be

forced to shut down its production and lay off employees. Wallace, PCB 02-207, slip op. at 3, 6.

 

The Board found that denial of variance would impose an arbitrary or unreasonable

hardship. Under all of these circumstances, the Board concluded that MedPointe

 

has demonstrated that denial of variance would impose an economic hardship.

Even with increased production, [MedPointe’s] VOM emissions will have

additional controls, and its addition to the VOM emissions in the area will be

minimal. Wallace, PCB 02-207, slip op. at 6.

 

The variance, granted through December 31, 2006, imposed several conditions. The

variance limited emissions from each of the five dryers to 5.0 tons per year of VOM emissions,

and additional daily limits were imposed on two of the dryers. Other conditions required that

various research, testing, and evaluation for control technology be accomplished by various

times certain, that regular progress reports be filed. Wallace, PCB 02-207, slip op. at 7-8.

 

THE JOINT MOTION

 

In their March 10, 2005 joint motion, the parties report 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 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

35 Ill. Adm. Code 215.480(a) for the duration of the variance . . . . Motion at 3-4.

 

The parties suggest that the variance order does not provide clear guidance under the current

situation, where MedPointe’s reported plantwide annual emissions for 2002 (6.87 tpy) and 2003

(1.2 tpy) are well below the 12.5 tpy (2.5 tpy x 5 dryers) applicability threshold in 35 Ill. Adm.

Code 480(a). To eliminate any question as to whether MedPointe must continue to submit

progress reports, the parties suggest “the variance should simply be withdrawn.” The parties

believe that variance withdrawal “would have no impact on Macon County’s attainment status,

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and if anything, will benefit the environment by eliminating the previously allowed increase in

daily and annual VOM emissions from the facility.” Motion at 4.

 

BOARD ANALYSIS AND CONCLUSION

TO TERMINATE MEDPOINTE’S ADJUSTED STANDARD

 

 

The Board appreciates the parties’ difficulty in determining the precise nature of

Medpointe’s obligations under the variance, given this unanticipated situation. Production of the

products giving rise to the need for the variance has all but ceased, according to the parties,

rather than increasing steadily as anticipated in 2002.

 

After careful consideration, the Board finds that termination of the variance is the

appropriate action, as MedPointe can no longer justify the need for the variance. As the parties

have suggested no other more appropriate date, the Board terminates MedPointe’s variance as of

the date of this opinion and order. For any enforcement purposes, then, MedPointe’s variance

from 35 Ill. Adm. Code Section 218.482(a) was effective from September 19, 2002 through

April 7, 2005.

 

 

This supplemental opinion constitutes the Board’s supplemental findings of fact and

conclusions of law.

 

ORDER

 

 

At the parties’ request, effective April 7, 2005, the Board terminates the September 19,

2002 variance granted in this docket from 35 Ill. Adm. Code Section 218.482(a) for five dryers

at the Wallace Pharmaceuticals (n/k/a MedPointe Pharmaceuticals) facility in Decatur, Macon

County.

 

IT IS SO ORDERED.

Section 41(a) of the Environmental Protection Act provides that final Board orders may

be appealed directly to the Illinois Appellate Court within 35 days after the Board serves the

order. 415 ILCS 5/41(a) (2002);

see also

35 Ill. Adm. Code 101.300(d)(2), 101.906, 102.706.

Illinois Supreme Court Rule 335 establishes filing requirements that apply when the Illinois

Appellate Court, by statute, directly reviews administrative orders. 172 Ill. 2d R. 335. The

Board’s procedural rules provide that motions for the Board to reconsider or modify its final

orders may be filed with the Board within 35 days after the order is received. 35 Ill. Adm. Code

101.520;

see also

35 Ill. Adm. Code 101.902, 102.700, 102.702.

 

 

I, Dorothy M. Gunn, Clerk of the Illinois Pollution Control Board, hereby certify that the

above supplemental opinion and order was adopted on the day of April 7, 2005, by a vote of 4-0.

 

Dorothy M. Gunn, Clerk

Illinois Pollution Control Board