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ILLINOIS POLLUTION CONTROL BOARD

March 4, 2008

RECEIVED

CLERK'S OFFICE

MAR - 4 2008

STATE OF ILLINOIS

Pollution Control Board

IN THE MATTER OF:

ABBOTT LABORATORIES' PROPOSED

SITE SPECIFIC AMENDMENT TO

APPLICABILITY SECTION OF ORGANIC

MATERIAL EMISSION STANDARDS AND

LIMITATIONS FOR THE CHICAGO AREA;

SUBPART T: PHARMACEUTICAL

MANUFACTURING (35 ILL. ADM. CODE

218.480(b))

R08-8

(Rulemaking - Air)

HEARING OFFICER ORDER

On September 4, 2007, Abbott Laboratories (Abbott) filed a proposal for site-specific

rulemaking pursuant to Section 28 of Environmental Protection Act (Act) (415 ILCS 5/28

(2006)), to allow it "additional operational flexibility" with regard to emissions from certain

tunnel dryers and fluid bed dryers at its pharmaceutical manufacturing facility (the Facility)

located in Libertyville Township, Lake County.

As explained in the January 31, 2008 hearing officer order, the hearing in this rulemaking

will be held in Libertyville on March 7, 2008, beginning at 1:00 p.m. Both the technical

justification and economic impact of the rules will be addressed at this hearing, as the Board

presently does not intend to schedule another hearing.

See

Section 27 (b) of the Act, 415 ILCS

5/27(b) (2006) and Section 102.414 of the Board's procedural rules, 35 III. Adm. Code 102.414.

On February 22, 2008, consistent with the hearing officer order, Abbott prefiled testimony

of Diane Beno and Robert C. Wells. The Illinois Environmental Protection Agency (Agency)

has not prefiled any testimony. No other testimony has been prefiled.

In the interest of facilitating the hearing process, the Board has reduced to writing

questions it would like the participants to address at hearing, and is making them available to

participants in advance of hearing. These questions appear on pages 2-5 of this order. While

some questions are addressed to particular witnesses, any participant is free to address any of the

questions.

The hearing officer has today telephoned counsel for Abbott and the Agency to advise

them of issuance of this order. The Board's Clerk's Office is placing this order on the Board's

website today, and is advising counsel who have filed appearances of its availability. This order

will also be served on all parties on the notice list for this proceeding.

Questions on Proposal

Pre-filed Testimony

Statement of Reasons

1. On page 3, the Statement of Reasons (SOR) states that the current VOM requirements at

Section 218.480(b) are based on the provisions of Section 215.480(b), which was adopted

by the Board on April 7, 1988 in Docket R86-10. Further, the SOR states that during

the rulemaking in R86-10 both the petitioner and IEPA "provided technical

documentation and testimony to the effect that certain emission sources, including tunnel

dryers and fluid bed dryers, would be economically infeasible to control at the levels

required for certain other emission sources at the facility."

Please comment on whether the information/testimony presented in the R86-

10 rulemaking regarding economic feasibility of controlling emissions from

Abbott's tunnel dryers and fluid bed dryers is still valid.

Has there been in any development in emissions control technology since the

adoption of the original rules that addresses the economic concerns associated

with control of emissions from the affected dryers?

2. On page 6, the SOR notes that the average actual emissions from the fluid bed dryers and

tunnel dryers for 1999 and 2000 were used to determine the proposed combined emission

limit of 20.7 tons per year. (This was revised to 20.6 tons per year in Abbott's February

29, 2008 motion to amend.) According to Exhibit 3, total emissions from years 1999 and

2000 represent the highest actual emissions. Starting from 2001 and until 2007, the total

actual emissions from the affected dryers are approximately half the total emissions in

1999 and 2000. Further, the VOM emissions data show a declining trend.

Please explain the reasons for the significantly lower actual emissions from

the dryers since year 2000.

The amended Exhibit 3 indicates that tunnel dryer #4 has zero VOM

emissions since 2005. Please explain whether Abbott has stopped operating

dryer #4.

Prefiled Testimony – Diane Beno

On page 2, you state that the organic solvent currently used for massing fluid in AP-16 is

ethanol. Please comment on whether Abbott has used organic solvents other than ethanol

in the manufacture of pharmaceuticals in the past. If so, please provide names of other

solvents used for massing fluid.

Please explain the basis for choosing the type of solvent used for massing fluid, i.e.

whether the solvent type is mainly dependent on the product being manufactured or the

type of solvent is also dependent on the type of dryer being used in the process.

3. On page 3, you state that Abbott has increased the use of fluid dryers for recently

developed products, and anticipates increased use of water for the massing fluid.

Please comment on whether Abbott anticipates increased use of water in product

lines using both tunnel dryers and fluid bed dryers.

Is the anticipated increase in use of water for massing fluid intended to reduce

VOM emissions? If so, have you made any estimates of the amount of VOM

reductions that may result from increased use of water?

Please elaborate on why Abbot considers water-based products as a "preferential

use".

Please explain what role, if any, pollution prevention (PP) plays in increasing the

use of water for massing fluid in future products. Does Abbott have some type of

an in-house PP incentive program to reduce VOM emissions? Please elaborate on

Abbott's PP activities as they may relate to the affected dryers.

4. Also on page 3, you note that increased use of fluid dryers is mainly because they are

more efficient and produce a more uniform product than tunnel dryers.

Please explain how the fluid bed dryers are more efficient than the tunnel dryers.

Does Abbott have any plans to replace the tunnel dryers with fluid dryers?

5. On page 4, you state that under the current rules, Abbott may be required to utilize a

dryer with low VOM emissions during the last 12 months instead of using the dryer that

is most efficient from a production-scale standpoint to ensure compliance with the current

running 12-month total VOM limit on each dryer.

Please clarify what you mean by "using the dryer that is most efficient from a

production-scale standpoint."

Other than a dryer's previous 12-month VOM emissions, what factors are

considered in deciding the type of dryer used for a particular campaign?

Prefiled Testimony – Robert Wells

1. On page 5, you state that under USEPA guidelines, "historical actual emissions" are

defined as the highest actual emissions from any 2-year period within the last 10 years of

operation. Please clarify whether the definition of "historical actual emissions" used in

your testimony is based on the USEPA's Economic Incentive Program (EIP) guidelines.

If not, please provide a complete citation to the appropriate USEPA publication, which

defines what constitutes historical actual emissions.

2. The USEPA's EIP guidelines at page 166 defines "historical actual emissions" as "actual

emissions associated with a source in a time period prior to the source's participation in

EIP, usually representing the average emissions of the past two years or some other more

representative period."

Please explain why the baseline was not calculated on the basis of average

emissions of the past two years (2006 & 2007).

If the basis for using the average emissions from 1999 and 2000 is because that

period is more representative, please explain why that time period is considered

representative. Particularly, since the emissions data indicate significantly lower

emission during 2001 to 2005.

USEPA's Economic Incentive Program Guidance

1. At page 3, the EIP guidance states that the guidance applies if a state or tribe wants to

establish a discretionary EIP for attaining or maintaining the national ambient air quality

standards (NAAQS) for criteria pollutants. Further, the guidance notes that any

government agency with the authority to administer a SIP or TIP may adopt a

discretionary EIP.

Does the above statement imply that the state should first adopt some type of a

discretionary EIP policy before considering a request such as the one made by

Abbott?

If so, has the Agency adopted an EIP policy for Illinois? If not, should this

rulemaking be considered as the State's adoption of the EIP policy?

Please comment on whether Abbott's proposal is the first request made under the

USEPA's EIP in Illinois.

2. At page 6, Mr. Wells states that in order to ensure that the proposed site-specific

amendment is consistent with USEPA EIP guidance, and to realize the administrative

benefit of a program, the program must satisfy three fundamental principles of USEPA's

EIP program: integrity, equity and environmental benefit. Does the Agency believe that

the proposed rule along with the supporting documentation satisfies the EIP principles?

3. At page 6 of Mr. Wells' testimony, Mr. Wells states that the principle of integrity consists

of four elements: emissions must be surplus, quantifiable, enforceable, and permanent.

Further he notes that these terms have specific meanings, and are different for a source

specific emissions cap (SSEC) than for other programs addressed by the policy.

a. Please clarify whether the SSEC elements are those described under Section

4.1(b) of the guidance at page 38.

b. Regarding emissions being surplus, is there any concern that the proposed

combined VOM limit may not be consistent with the EIP guidance since the

baseline is calculated on the basis of highest actual emissions?

Proposed Amendments

1. Abbott's

proposal amends the existing rules at 35 Ill. Adm. Code 218.480(b), which

sets forth that the VOM limits apply to air suspension dryers, fluid bed dryers, tunnel

dryers, and Accelacotas located in Libertyville Township, Lake County, Illinois.

Please comment on whether the rules should specifically state that the VOM limits

apply to dryers located at the Abbott Laboratories, Building AP16, especially since

the proposed amendments at Section 218.480(b)(4) refer specifically to certain

numbered fluid bed dryers, and tunnel dryers.

Abbot's February

29, 2008

Motion to Amend

This order does not address Abbott's February 29, 2008 motion to amend Exhibit 3 as

well as the text of its proposal. This motion is better addressed at hearing.

Again, at the close of hearing, the hearing officer will set a date by which the record will

close and all public comments must be submitted. See 35 III. Adm. Code 102.108. As the Board

is aware that Abbott would appreciate Board decision making as soon as possible, the

posthearing comment period will not be lengthy unless unanticipated circumstances dictate

Hearing Officer, Illinois Pollution Control Boar

100 West Randolph Street, Suite 11-500

Chicago, Illinois 60601

(312) 814-6929 crowlek@ipcb.state.il.us