Electronic Filing, R'eceived,. Clerk"s.Office, September 4, 200lePA ATTACHMENT NO. I * * * * * R2008 008 * * * * * -

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

IN THE MATTER OF:

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-__

(Rulemaking - Air)

NOTICE OF FILING

TO: Mr. John T. Therriault

Assistant Clerk ofthe Board

Illinois Pollution Control Board

100 West Randolph Street

Suite 11-500

Chicago, Illinois 60601

(VIA ELECTRONIC MAIL)

(SEE PERSONS ON ATTACHED SERVICE LIST)

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

the Illinois Pollution Control Board an ENTRY OF APPEARANCE OF KATHERINE

D. HODGE; ENTRY OF APPEARANCE OF GALE W. NEWTON; MOTION TO

WAIVE REQUIREMENT TO SUBMIT 200 SIGNATURES; MOTION FOR

EXPEDITED REVIEW; ABBOTT LABORATORIES' PROPOSAL OF

AMENDMENTS; and STATEMENT OF REASONS, copies ofwhich are herewith

served upon you.

Respectfully submitted,

ABBOTT LABORATORIES,

Dated: September 4, 2007 By: lsi Katherine D. Hodge

One ofIts Attorneys

Katherine D. Hodge

Gale W. Newton

HODGE DWYER ZEMAN

3150 Roland Avenue

Post Office Box 5776

Springfield, Illinois 62705-5776

(217) 523-4900

ABOT:003/Fil/NOF - site-specific rulemaking 218.480

TillS FILING SUBMITTED ON RECYCLED PAPER
•.,••~"~._,.~ •. , ,. !,! ,'''''' """" (/~ ,;, lIectronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

CERTIFICATE OF SERVICE

I, Katherine D. Hodge, the undersigned, certify that I have served the attached ENTRY

OF APPEARANCE OF KATHERINE D. HODGE; ENTRY OF APPEARANCE OF GALE W.

NEWTON; MOTION TO WAIVE REQUIREMENT TO SUBMIT 200 SIGNATURES;

MOTION FOR EXPEDITED REVIEW; ABBOTT LABORATORIES' PROPOSAL OF

AMENDMENTS; and STATEMENT OF REASONS upon:

Mr. John T. Therriault

Assistant Clerk ofthe Board

Illinois Pollution Control Board

100 West Randolph Street

Suite 11-500

Chicago, Illinois 60601

via electronic mail on September 4,2007; and upon:

Division ofLegal Counsel

Illinois Environmental Protection Agency

1021 North Grand Avenue East

Post Office Box 19276

Springfield, Illinois 62794-9276

Office ofLegal Services

Illinois Department ofNatural Resources

One Natural Resources Way

Springfield, Illinois 62702

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

on September 4,2007.

lsI Katherine D. Hodge

Katherine D. Hodge

ABOT:003/FiIlCOS - Part 218
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

IN THE MATTER OF: )

)

PROPOSED SITE-SPECIFIC )

AMENDMENT TO APPLICABILITY )

SECTION OF ORGANIC )

MATERIAL EMISSION STANDARDS )

AND LIMITATIONS FOR THE )

CHICAGO AREA; SUBPARTT: )

PHARMACEUTICAL )

MANUFACTURING )

(35 ILL. ADM. CODE 218.480(b)) )

R08-

(Rulemaking - Air)

ENTRY OF APPEARANCE OF KATHERINE D. HODGE

NOW COMES Katherine D. Hodge, ofthe law firm HODGE DWYER ZEMAN,

and hereby enters her appearance in this matter on behalf ofAbbott Laboratories.

Respectfully submitted,

By: /s/ Katherine D. Hodge

Katherine D. Hodge

Dated: September 4, 2007

Katherine D. Hodge

HODGE DWYER ZEMAN

3150 Roland Avenue

Post Office Box 5776

Springfield, Illinois 62705-5776

(217) 523-4900

ABOT:003/FiI/EOA - KDH 218
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

IN THE MATTER OF: )

)

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-

(Rulemaking - Air)

ENTRY OF APPEARANCE OF GALE W. NEWTON

NOW COMES Gale W. Newton, ofthe law firm HODGE DWYER ZEMAN, and

hereby enters his appearance in this matter on behalf ofAbbott Laboratories.

Respectfully submitted,

By: /s/ Gale W. Newton

Gale W. Newton

Dated: September 4, 2007

Gale W. Newton

HODGE DWYER ZEMAN

3150 Roland Avenue

Post Office Box 5776

Springfield, Illinois 62705-5776

(217) 523-4900

ABOT:003/Fil/EOA - GWN 218
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

IN THE MATTER OF: )

)

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-

(Rulemaking - Air)

MOTION TO WAIVE REQUIREMENT TO SUBMIT 200 SIGNATURES

NOW COMES ABBOTT LABORATORIES ("Abbott"), by and through its

attorneys, HODGE DWYER ZEMAN and requests the Illinois Pollution Control Board

("Board") to waive the requirement, under 35 Ill. Admin. Code § 102.202(g), to submit

200 signatures with its Proposed Amendments to 35 Ill. Admin. Code Part 218 ("Part

218") stating as follows:

1. Abbott owns a pharmaceutical manufacturing facility in Libertyville

Township, Lake County, Illinois for which it seeks site-specific amendments to

regulations involving the applicability of an exemption for certain dryers.

2. The Board has waived signature requirements for site-specific rulemaking

petitions in the past, including recently In the matter ofPetition ofCentral Illinois Light

Company for a Site Specific Air Rule 35 III Adm Code 214141, R02-21; In the Matter of

Petition ofthe City ofEffingham, Blue Beacon International Inc. and Truckomat

Corporation for a Site Specific Water Pollution Regulation: 35 Ill. Admin. Code 304.105,

R03-11; and In The Matter of: Proposed Site Specific Regulation Applicable to Ameren

Energy generating Company, Elgin, Illinois Amending 35 IL. Adm. Code 901, R04-11.
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

3. Abbott is a publicly held company that employs thousands ofpeople

nationwide and that manufactures pharmaceuticals that are used by millions of customers

in the State ofIllinois and worldwide. Granting this motion is in the public interest of ,

those customers and others served by Abbott.

WHEREFORE, ABBOTT LABORATORIES, through its attorneys, respectfully

requests the Illinois Pollution Control Board to waive the requirement to submit 200

signatures in support ofits Proposed Amendments to 35 Ill. Admin. Code Part 218.

Respectfully submitted,

ABBOTT LABORATORIES,

By: /s/ Katherine D. Hodge

One ofits Attorneys

Dated: September 4, 2007

Katherine D. Hodge

Gale W. Newton

HODGE DWYER ZEMAN

3150 Roland Avenue

Post Office Box 5776

Springfield, Illinois 62705-5776

(217) 523-4900

ABOT:003/Fil/Motion to Waive Signatures

2
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

IN THE MATIER OF: )

)

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-

(Rulemaking - Air)

MOTION FOR EXPEDITED REVIEW

NOW COMES ABBOTT LABORATORIES ("Abbott"), by and through its

attorneys, HODGE DWYER ZEMAN, and hereby requests the Illinois Pollution Control

Board ("Board") to expedite review ofAbbott's Proposal ofAmendments to 35 Ill.

Admin. Code Part 218.480(b). In support ofthis Motion, Abbott states as follows:

1. As set forth in the Proposal ofAmendments to 35 Ill. Admin. Code Part

218.480(b) ("Part 218.480(b)"), Abbott seeks to amend Part 218.480(b). Simultaneously

with this Motion, Abbott is filing a StatementofReasons that describes the purpose and

effect that the proposed changes will have on the administration ofPart 218.480(b)

requirements.

2. Part 218.480(b), contains the site-specific applicability requirements for

certain regulations regarding organic material emission standards and limitations for

pharmaceutical manufacturing at Abbott's Libertyville Township, Lake County, Illinois

facility.
Electronic Filing, Received,Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

3. The rule, as it stands, requires Abbott to utilize its equipment and

resources in a manner that is inefficient for the production of certain ofits pharmaceutical

products.

4. Continued operation in the inefficient manner described above causes

material prejudice to Abbott.

5. The proposed amendments are primarily intended to increase efficiency

for Abbott's use of certain fluidized bed and tunnel dryers while providing for lower

allowable emissions from these dryers as a group.

6. The Illinois Environmental Protection Agency has been contacted and has

no disagreement with the proposed amendments.

7. The proposed rulemaking may be sent to first notice without a decision

being reached on the merits ofthe proposal by the Board. See, for example: In The

Matter Of: Revisions to Water Quality Standards for Total Dissolved Solids in the Lower

Des Plaines River ExxonMobil Oil Corporation 2006 Ill. ENV LEXIS 167 (Ill. ENV

2006); In The Matter Of: Proposed Site Specific Regulation Applicable to Ameren

Energy Generating Company, Elgin 2003 Ill. ENV LEXIS 667 (Ill. ENV 2003); and In

The Matter Of: Petition OfW.R. Grace & Company.,. Connecticut, and the Illinois EPA

For Site-Specific Air Regulation, 1997 Ill. ENV LEXIS 717 (Ill. ENV 1997).

8. Therefore, Abbott requests that the Board proceed to First Notice under

the Illinois Administrative Procedure Act, 5 ILCS 100/1-1, etseq., without reaching a

decision on the merits, by accepting the regulatory language proposed by Abbott in this

rulemaking proposal only for purposes ofFirst Notice.

2
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

9. Abbott also requests that the requisite hearing be scheduled as soon as

possible in accordance with Section 28(a) ofthe Illinois Environmental Protection Act,

415 ILCS 5/28(a).

10. Abbott believes that the information necessary for the Board to proceed to

First Notice in this rulemaking and schedule a public hearing is contained in the

Statement ofReasons. Ifmore information is needed, Abbott will cooperate fully to

expeditiously provide the same to the Board and its hearing officer.

11. As required by 35 Ill. Admin. Code § 101.512, this Motion is

accompanied by an affirmation attesting that the facts cited herein are true.

WHEREFORE, for the above and foregoing reasons, ABBOTT

LABORATORIES hereby respectfully requests the Illinois Pollution Control Board to

expedite review in this matter.

Respectfully submitted,

ABBOTT LABORATORIES

By: lsI Katherine D. Hodge

One ofIts Attorneys

Date: September 4, 2007

Katherine D. Hodge

Gale W. Newton

HODGE DWYER ZEMAN

3150 Roland Avenue

Post Office Box 5776

Springfield, Illinois 62705-5776

(217) 523-4900

3
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

AFFIDAVIT

STATE OF ILLINOIS

COUNTYOF~

)

) SS.

)

Diane Beno, being first dilly sworn on oath, affirms that, based upon appropriate

inquiry, the facts set forth in the Motion for Expedited Review above are true and correct.

Diane Beno, AP16 Plant Manager

Abbott Laboratories

100 Abbott Park Road

Abbott Park, Illinois

847/937-1321

Subscribed and sworn to before me

this?day Of~1l6t, 2007.
R08-

(Rulemaking - Air)

Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

IN THE MATTER OF: )

)

PROPOSED SITE-SPECIFIC )

AMENDMENT TO APPLICABILITY )

SECTION OF ORGANIC )

MATERIAL EMISSION STANDARDS )

AND LIMITATIONS FOR THE )

CHICAGO AREA; SUBPARTT: )

PHARMACEUTICAL )

MANUFACTURING )

(35 ILL. ADM. CODE 218.480(b)) )

ABBOTT LABORATORIES' PROPOSAL OF AMENDMENTS

ABBOTT LABORATORIES ("Abbott"), by and through its attorneys, HODGE

DWYER ZEMAN, pursuant to 35 Ill. Admin. Code § 102.202, moves the Illinois

Pollution Control Board to accept for hearing Abbott's proposal for amendment of 35 Ill.

Admin. Code Part 218, Subpart T, Section 218.480(b). This regulatory proposal

includes: 1) the Proposed Amendments; 2) the Statement ofReasons; 3) Appearances for

the attorneys representing Abbott; 4) a Motion to Waive Requirement to Submit 200

Signatures; and, 5) a Motion for Expedited Review.

Respectfully submitted,

ABBOTT LABORATORIES,

Dated: September 4, 2007

Katherine D. Hodge

Gale W. Newton

HODGE DWYER ZEMAN

3150 Roland Avenue

Post Office Box 5776

Springfield, Illinois 62705-5776

(217) 523-4900

ABOT:003/Fil/Proposal ofAmendment - 218 v2

By: /s/ Katherine D. Hodge

One ofIts Attorneys
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

PROPOSED AMENDMENTS

TITLE 35: ENVIRONMENTAL PROTECTION

SUBTITLE B: AIR POLLUTION

CHAPTER I: POLLUTION CONTROL BOARD

SUBCHAPTER c: EMISSIONS STANDARDS AND

LIMITATIONS FOR STATIONARY SOURCES

PART 218

ORGANIC MATERIAL EMISSION STANDARDS AND

LIMITATIONS FOR THE CmCAGO AREA

SUBPART T: PHARMACEUTICAL MANUFACTURING

Section 218.480 Applicability

a) The rules ofthis Subpart, except for Sections 218.483 through 218.485 of

this Part, apply to all emission units ofVOM, including but not limited to

reactors, distillation units, dryers, storage tanks for VOL, equipment for

the transfer ofVOL, filters, crystallizers, washers, laboratory hoods,

pharmaceutical coating operations, mixing operations and centrifuges used

in manufacturing, including packaging, ofpharmaceuticals, and emitting

more than 6.8 kg/day (15Ibs/day) and more than 2,268 kg/year (2.5

tons/year) ofVOM. Ifsuch an emission unit emits less than 2,268 kg/year

(2.5 tons/year) ofVOM, the requirements ofthis Subpart still apply to the

emission unit ifVOM emissions from the emission unit exceed 45.4

kg/day (100 lbs/day).

b) Notwithstanding subsection (a) ofthis Section, the air suspension

coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located in

Libertyville Township, Lake County, Illinois shall be exempt from the

rules ofthis Subpart, except for Sections 218.483 through 218.485, if

emissions ofYOM not vented to air pollution control equipment do not

exceed the following levels:

1) For the air suspension coater/dryer: 2,268 kg/year (2.5 tons/year);

2) Except as set forth in Subsection 218.480(b)(4) below, for W:w-each

fluid bed dryer: 4,535 kg/year (5.0 tons/year);

3) Except as set forth in Subsection 218.480(b)(4) below. IorF-ef each

tunnel dryer: 6,803 kg/year (7.5 tons/year); fffiEl

4) For fluid bed dryers #1, #2 and #3 and f()r tunnel dryers #1, #2, #3

. and #4. the combined total annual emissions from the dryers listed
Electronic Filing, Received,Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

in this Subsection 218.480(b)(4) shall not exceed: 18,779 kg/year

(20.7 tons/year) [NOI'E: tu.nnel dryers are otherwise refcncd to as

warm air dryers]: and

4~) For each Accelacota: 6,803 kg/year (7.5 tons/year).

c) Sections 218.483 through 218.485 ofthis Part apply to a source having

one or more emission units that:

1) Are used to manufacture pharmaceuticals, and

2) Emit more than 6.8 kg/day (15Ibs/day) ofVOM and more than

2,268 kg/year (2.5 tons/year) ofVOM, or, ifless than 2,268

kg/year (2.5 tons/year), these Sections still apply if emissions from

one or more sources exceed 45.4 kg/day (100 lbs/day).

d) No owner or operator shall violate any condition in a permit when the

condition results in exclusion of an emission unit from this Subpart.

e) Any pharmaceutical manufacturing source that becomes subject to the

provisions ofthis Subpart at any time shall remain subject to the

provisions ofthis Subpart at all times.

f) Emissions subject to this Subpart shall be controlled at all times consistent

with the requirements set forth in this Subpart.

g) Any control device required pursuant to this Subpart shall be operated at

all times when the source it is controlling is operated.

h) Determinations of daily and annual emissions for purposes ofthis Section

shall be made using both data on the hourly emission rate (or the

emissions per unit ofthroughput) and appropriate daily and annual data

from records of emission unit operation (or material throughput or

material consumption data). In the absence ofrepresentative test data

pursuant to Section 218.487 ofthis Part for the hourly emission rate (or

the emissions per unit ofthroughput) such items shall be calculated using

engineering calculations, including the methods described in Appendix B

of "Control ofVolatile Organic Emissions from Manufacturing of

Synthesized Pharmaceutical Products" (EPA-450/2-78-029), incorporated

by reference in Section 218.112 ofthis Part. (This subsection shall not

affect the Agency's or the USEPA's authority to require emission tests to

be performed pursuant to Section 218.487 ofthis Part.)

i) Equipment and operations emitting YOM at a source subject to subsection

(a) or (c) ofthis Section and used to produce pharmaceutical products or a

pharmaceutical-like product such as a hormone, enzyme, or antibiotic,
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

shall be deemed to be engaged in the manufacture ofpharmaceuticals for

the purposes ofthis Subpart.

(Source: Amended at Ill. Reg. -'effective..-pi\""ifaa:)r"9~,-il~9~9Zl~~. .J)
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD

IN THE MATTER OF: )

)

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-

(Rulemaking - Air)

STATEMENT OF REASONS

Abbott Laboratories, an Illinois corporation, ("Abbott") hereby submits this

Statement ofReasons to the Illinois Pollution Control Board ("Board") pursuant to

Sections 27 and 28 ofthe Illinois Environmental Protection Act ("Act") (415 ILCS 5/27

and 28),35 Ill. Admin. Code § 102.210 and 35 Ill. Admin. Code § 102.202(b), in support

ofthe attached proposed site-specific amendment to 35 Ill. Admin. Code § 218.480.

Abbott owns a pharmaceutical manufacturing facility located in Libertyville

Township, Lake County, Illinois ("the Facility"). Abbott produces numerous

pharmaceutical products at the Facility, and these operations are subject to 35 Ill. Admin.

Code, Subpart T - Pharmaceutical Manufacturing ("Subpart T"). As currently written,

Subpart T, Section 218.480(b) ("Section 218.480(b)") contains certain exemptions that

are only applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel

dryers, and Accelacotas located at the Facility. Abbott is proposing to amend these sitespecific exemptions by lowering the overall emissions allowable under the exemptions

from its tunnel dryers numbered #1, #2, #3 and #4, and fluid bed dryers numbered #1, #2

and #3, and calculating the amount of exempted emissions from the dryers listed above
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

based on the actual combined emissions from the dryers. If adopted, the proposed

amendment would reduce the overall allowable emissions from these units while

increasing Abbott's operational flexibility with regard to these units.

I. SITE DESCRIPTION AND AREA AFFECTED

Abbott is located at 100 Abbott Park Road in unincorporated Lake County.

Abbott is a worldwide health care corporation with its headquarters located at this site.

Abbott conducts manufacturing and packaging ofsolid dosage form pharmaceuticals

(tablets, capsules, and granules) and liquid dosage form pharmaceuticals, preparation and

filling ofbulk solutions for diagnostic kit reagents, final packaging and distribution of

diagnostic kits, and research and development activities from bench-scale through small

pilot plant processes. Abbott also operates manufacturing support services that include

boilers, chillers, emergency generators, and other support services.

The units affected by the proposed amendment are located near the center of

Abbott's 567-acre facility. See aerial photograph attached as Exhibit 1. The site includes

developed parcels with numerous buildings that house the on-site activities, plus

contiguous parcels of agricultural and vacant land. The area surrounding the site includes

a mixture ofresidential, commercial, and industrial land use.

II. STATEMENT OF FACTS AND PURPOSE AND EFFECT OF PROPOSAL

A. Facts

1. Process

The operations associated with this proposed amendment, contained in Building

AP16, produce intermediate and final pharmaceutical product formulations, including

2
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

products utilized in the anti-infective, cardiovascular, vitamin and mineral supplement,

epileptic, arthritic, allergic, and human immunodeficiency areas. The general process

flow involves: receipt ofraw materials; weighing ofingredients; granulation of

ingredients; compressing granulated product into tablets; coating tablets or particles;

printing symbols onto finished products; and packaging finished products for distribution.

The process includes drying certain products in tunnel dryers or fluid bed dryers.

2. Hazardous Air Pollutants

The processes associated with this proposed amendment do not involve the

emissions of any Hazardous Air Pollutants.

3. Original Section 218.480(b) Rulemaking

The economic infeasibility ofinstalling controls on the tunnel dryers and/or the

fluid bed dryers was discussed during the original rulemaking regarding Section

218.480(b). Section 218.480(b) was promulgated after, and is essentially identical to, 35

Ill. Admin. Code § 215.480(b) ("Section 215.480(b)"). During the rulemaking process

that resulted in the promulgation of Section 215.480(b), both Abbott and the Illinois

Environmental Protection Agency (the "Illinois EPA") 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. See Amendments to 35 Ill. Adm. Code 211

& 215 Organic Material Emission Standards and Limitations for Synthesized

Pharmaceutical Manufacturing Plants, IPCB, R86-10. Therefore, the exemption

promulgated in Section 215.480(b), and carried into Section 218.480(b), was included in

3
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

the regulations. As currently written, the tunnel dryers and fluid bed dryers are exempt

from the other requirements ofSubpart T (except for Sections 218.483 through 218.485

of Subpart T, which cover material storage and transfer, in-process tanks, and leaks,

respectively) so long as the emissions ofVOM not vented to air" pollution control

equipment do not exceed 4,535 kg per year (5.0 tons per year) for each fluid bed dryer

and 6,803 kg per year (7.5 tons per year) for each tunnel dryer.

The Facility currently operates four tunnel dryers and four fluid bed dryers 1. The

dryers are designated as tunnel dryers2 numbered #1, #2, #3 and #4 and fluid bed dryers

numbered #1, #2, #3 and #4. One ofthe fluid bed dryers, designated in the Facility's

CAAPP permit as fluid bed dryer #4, is used in research and development operations and

is not involved in the manufacturing processes. The proposed amendment would not

affect this dryer and the discussion offluid bed dryers in this Statement ofReasons does

not include fluid bed dryer #4 unless a specific reference is made to that dryer. The

CAAPP permit names and emission unit designations for the seven affected dryers are

presented in Table 1.

TABLEt

Seven Affected Dryers as Described in CAAPP Permit

CAAPP Permit Dryer Name CAAPP Permit Dryer Emission Unit

Number

Warm Air Dryer 1 D-0964

Warm Air Dryer 2 D-0965

Warm Air Dryer 3 D-0966

Warm Air Dryer 4 D-0967

1 In 1988, during the initial rulemaking, Abbott operated eight tunnel dryers and two fluid bed dryers.

2 The rule and the CAAPP permit use different nomenclature for the tunnel dryers. In the current version

ofthe rule and the proposed version ofthe rule, the term "Tunnel Dryers" is used. In the CAAPP permit,

the same dryers are referred to as "Warm Air Dryers."

4
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

CAAPP Permit Dryer Name CAAPP Permit Dryer Emission Unit

Number

G-0917

Aeromatic Model No. T-8 2400 Fluid Bed

Dryer (FBD #1)

Aeromatic Model No. T-8 2400 Fluid Bed G-0955

Dryer (FBD #2)

Aeromatic Model No. MP-8 Fluid Bed LC933770

Dryer (FBD #3)

With respect to the seven affected dryers, the total YOM emissions currently

allowed under the Subpart T exemption are 30 tons per year from the tunnel dryers and

15 tons per year from the fluid bed dryers, or a combined total of 45 tons ofVOM

emissions per year from all seven dryers.

4. Proposal

Abbott proposes a source-specific cap for the fluid bed dryers and tunnel dryers

under the United States Environmental Protection Agency's ("USEPA") Economic

Incentive Program ("ElP"). Pursuant to the EIP guidance, a source-specific emission cap

EIP substitutes a mass-based emissions cap for a rate-based limit. See Improving Air

Quality with Economic Incentive Programs, USEPA, January 2001, Pg. 97. Attached as

Exhibit 2. Source-specific emission cap EIPs are intended to limit total emissions while

providing compliance flexibility. Id. at 96. Per discussions with the Illinois EPA and

USEPA, in a source-specific emission cap EIP, a source may establish a baseline based

on the average actual emissions over any two consecutive years during the past ten year

period. The baseline must then be reduced by 10 percent to demonstrate environmental

benefit.

5
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

The proposed amendment would combine the emissions from the fluid bed dryers

and tunnel dryers. The average actual emissions from the fluid bed dryers and tunnel

dryers for 1999 and 2000 were 22.9 tons per year ofVOM. See Exhibit 3. As discussed

above, the allowable YOM emissions under the Subpart T exemption from the fluid bed

dryers and tunnel dryers for 1999 and 2000 were (and remains) 45 tons per year ofVOM.

Therefore, the actual average emissions of22.9 tons per year ofVOM for 1999 and 2000

are the lower ofthe actual or allowable emissions as required by the EIP guidance. The

proposed amendment would set the emissions cap for the combined emissions from the

fluid bed dryers and tunnel dryers at 10 percent less than the actual average emissions,

i.e., 20.7 tons per year, in order for such dryers to remain under the exemption. Thus, the

proposed amendment would reduce the total allowable emissions from the two categories

of dryers by 24.3 tons per year, as compared with the emissions allowed currently under

the exemption.

B. Reasons for Proposed amendment

1. Technology Shift

First, Abbott operates both tunnel dryers and fluid bed dryers during its

manufacturing processes. In earlier years, Abbott utilized tunnel dryers for most ofits

processes. Tunnel dryers are an effective means of drying certain products, however,

Abbott has increased its use offluid bed dryers in recent years because they are more

efficient than the tunnel dryers. In order to manufacture its products in the most efficient

manner, Abbott expects that the preferential use offluid bed dryers will continue.

6
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

2. General Flexibility

Second, Abbott manufactures its products using batch processes whereby the

equipment (including the dryers) produces one product at a time in fixed batch sizes.

Extensive equipment cleaning is required between batches ofdifferent products resulting

in up to three days oflost production time; therefore, Abbott uses a campaign strategy to

continue running batches ofthe same product consecutively to minimize cleaning time.

As could be expected, the manufacturing processes involved in the production of

different products emit differing amounts ofVOM. As currently written, Section

218.480(b) can limit Abbott's ability to schedule the campaigns of certain products to

maximize the efficiency ofthe processes. In other words, to ensure compliance with the

current running 12-month total YOM limit on each dryer for a particular batch, Abbott

may be required to utilize the dryer with the least amount ofVOM emissions during the

last 12 months, instead of using the dryer which is the most efficient from a production

standpoint. Such selection of dryers, based merely on the amount ofVOM that has been

emitted from an individual dryer during the preceding 12 months, is an arbitrary and

inefficient approach to scheduling the use ofAbbott's equipment and resources.

Additionally, a campaign can utilize any ofthe fluid bed dryers; the dryer selected for a

given campaign will depend on dryer availability and other factors. For example,

Abbott's equipment must undergo stringent cleaning and preventative maintenance

activities in accordance with United States Food and Drug Administration ("US FDA")

current Good Manufacturing Practice ("cGMP") guidelines. One fluid bed dryer may be

temporarily out of use to allow for these activities or for unscheduled maintenance

7
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

requirements. The most efficient method ofmanufacturing Abbott's products would be

to use the dryer that is best suited to the requirements ofthe manufacturing schedule

irrespective ofthe amount ofVOM that has been emitted from that dryer in the past 12

months. So long as the combined YOM emissions from all ofthe dryers ofthat type are

less than the amount allowed under Section 218.480(b), this method ofoperation would

not result in any increased YOM emissions at the Facility. In fact, the proposed

amendment would provide Abbott improved production flexibility while lowering the

total allowed Volatile Organic Material emissions from all the dryers combined.

E. Purpose and Effect

The amendment groups the YOM emissions from the dryers for the purpose of

meeting the emission requirements for the exemption from portions of Subpart T and

allows Abbott greater flexibility in its manufacturing processes. The proposed

amendment would lower, by 24.3 tons per year, the total amount ofVOM that is allowed

to be emitted by the affected dryers pursuant to the. Subpart T exemption. Further, the

proposed amendment would allow Abbott to utilize the most efficient process unit for

each batch process, irrespective ofrecent past usage ofspecific equipment.

III. GEOGRAPIDC REGIONS AND SOURCES AFFECTED

Since the proposed amendment would actually reduce the amount ofVOM

emissions that the Facility is allowed to release and still be allowed to claim the Section

218.480(b) exemption, the geographic area and source affected by this proposal is the

Facility located in Libertyville Township, Lake County, Illinois and its surroundings.

8
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

IV. TECHNICAL FEASIBILITY AND ECONOMIC

REASONABLENESSIIMPACT AND AVAILABLE TREATMENT OR

CONTROL OPTIONS

The proposed amendment to 35 Ill. Admin. Code § 218.480 will not impose any

new requirements on any affected source other than Abbott.

V. ENVIRONMENTAL IMPACT OF PROPOSED AMENDMENT

As discussed herein, the proposed amendment would reduce the amount ofVOM

emissions that the Facility is allowed to emit under the Section 218.480(b) exemption to

an amount which is not only below the current allowable emissions, but also below

historic actual emissions. Therefore, it is reasonable to assume that any environmental

impact associated with the proposed amendment would be a positive environmental

impact.

VI. COMMUNICATION WITH INTERESTED PARTIES

Abbott has had several discussions with the Illinois EPA and USEPA regarding

the need for the proposed amendment. The USEPA suggested that a source-specific

emission cap EIP may be an appropriate mechanism to accomplish Abbott's goal as

described herein. The Illinois EPA has agreed that the proposed amendment is

appropriate and that the amendment would not result in an increase in allowable

emissions.

VII. SYNOPSIS OF TESTIMONY

Abbott plans to present testimony from Ms. Diane Beno, AP16 Plant Manager, as

well as from Mr. Robert Wells, Manager, Air, Global Environmental Health & Safety.

9
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

This testimony will focus on the need for the proposed amendment based on the process

changes and need for flexibility as described above.

VIII. MATERIALS INCORPORATED

The proposed amendment does not incorporate any materials by reference.

IX. CERTIFICATION OF MOST RECENT REGULATION

The provision that is proposed for amendment is 35 Ill. Admin. Code § 218.480.

Abbott certifies, by its counsel's signatures below, that the portion of 35 Ill. Admin. Code

§ 218.480 cited in this proposal is the most recent version of 35 Ill. Admin. Code

§ 218.480, as published on the Board's web-site.

http://www.ipcb.state.il.us/documents/dsweb/Get/Document-11929/

x. CONSISTENCY WITH FEDERAL LAW

The proposed amendment is not inconsistent with the federal Clean Air Act or

other federal air regulations. In fact, the proposed amendment is based directly on the

USEPA ElP guidance. See Exhibit 2. The proposed regulatory revision will affect

Illinois' State Implementation Program ("SIP"). Therefore, ifthe proposed regulatory

amendment is approved, Illinois EPA will submit a SIP revision to the USEPA.

XI. CONCLUSION

Abbott has discussed the proposed amendment with Illinois EPA. The proposed

amendment would: (1) allow Abbott to use the combined actual emissions from its

affected tunnel dryers and fluid bed dryers to determine the applicability of Subpart T to

these units; and, (2) decrease the overall YOM emissions that would be allowed from its

tunnel dryers and fluid bed dryers as a group relating to the 35 Ill. Admin. Code Section

10
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

218.480(b) exemption, while increasing operational flexibility. The proposed

amendment would not impose any new control requirements on any source other than

Abbott or result in any increase in emissions.

WHEREFORE, for the reasons stated above, ABBOTT LABORATORIES

hereby submits this regulatory proposal and requests the lllinois Pollution Control Board

adopt these proposed amendments to 35 Ill. Admin. Code § 218.480.

Respectfully submitted,

ABBOTT LABORATORIES,

Dated: September 4, 2007

Katherine D. Hodge

Gale W. Newton

HODGE DWYER ZEMAN

3150 Roland Avenue

Post Office Box 5776

Springfield, lllinois 62705-5776

(217) 523-4900

By: /s/ Katherine D. Hodge

One ofits Attorneys

11
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

AFFIDAVIT

STATE OF ILLINOIS

COUNTY OF h.Q.Ke-

)

) SS.

)

Diane Beno, being first duly sworn on oath, affirms that, based upon appropriate

inquiry, the facts set forth in the Statement ofReasons above are true and correct.

Diane Beno,

~~AP16 Plant Manager

Abbott Laboratories

100 Abbott Park Road

Abbott Park, Dlinois ZIP

847/937-1321

Subscribed and sworn to before me

thi~day OrC\lljt1'6+' 2007.
EI.ctronl~ ~I~~ =::"00'\ ~':~ .Dfftc.. S..phl....r4, 2007

LEGEND:

o ABBOTT FROFERlY

BOUNDARY

FLUID BED DRYERS *TUNNEL DRYERS

EXHIBIT I

AERIAL FHOTOGRAFH OF ABBOTT FARK AND VICINllY

L1BERlYVILLE TOWNSHIF, ILLINOIS

APPR.OXJMATE SCALE: I" -I QO(J.(J"

100 500 1000 2000 3000 @)
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

United States

Environmental Protection

Agency

Office of Air and Radiation EPA-452/R-01-001

January 2001

&EPA Improving Air Quality with

Economic Incentive Programs
This document is not included herein. 

Given the volume of this document, EPA 

is opting not to make an electronic copy 

available in the docket. We have 

included an electronic copy of the 

document cover and the Table of 

Contents for information purposes. 

Readers interested in examining this 

document should contact: 

Steven Rosenthal 

(312) 886-6052 

rosenthal.steven@epa.gov
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

EPi\-452nR-01-001

IMPROVING AIR QUALITY WITH

ECONOMIC INCENTIVE PROGRAMS

Prepared by the

Innovative Strategies and Economics Group (MD-15)

Air Quality Strategies and Standards Division

Office ofi\ir Quality Planning and Standards

U.S. Environmental Protection Agency

Research Triangle Park, North Carolina 27711

U.S. ENVIRONMENTAL PROTECTION AGENCY

Office ofi\ir and Radiation

Office ofi\ir Quality Planning and Standards

January 2001
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

This page intentionally left blank.
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

TABLE OF CONTENTS

Selecting and Approving EIPs

1.0 General 3

1.1 What does this Federal EIP guidance cover? 3

1.2 Who should follow this guidance? 5

1.3 Why should I develop an EIP? 5

1.4 What are the goals ofthis guidance? 8

1.5 How does this guidance affect the EPA's 1994 EIP rule? 8

1.6 How does this guidance apply to existing EIPs? 9

1.7 What programs are not covered by this guidance? 9

1.8 What is the general process for getting my EIP approved? 11

1.9 What does the EPA mean when it says this is guidance? 12

2.0 DefiIring an EIP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.1 What is an EIP? 15

2.2 What pollutants are covered? 16

2.3 What sources may I include in my EIP? 16

2.4 What are the objectives ofEIPs? 16

3.0 Selecting Your EIP Type 17

3.1 How do I select the type ofEIP that will work best for me? 17

3.2 Whom should I involve in selecting and developing my EIP? 28

3.3 How do I apply this guidance to a particular type ofEIP? 29

Elements ofAll EIPs

4.0 Fundamental Principles ofAll EIPs 33

4.1 How must my EIP meet the integrity principle? 34

4.2 How must my EIP meet the equity principle? 45

4.3 How must my EIP meet the environmental benefit principle? 49

5.0 Common Elements ofAll EIPS 53

5.1 What provisions do I need to incorporate my EIP into my SIP? 53

5.2 How do I quantify the results ofmy EIP? 59

5.3 What features must I include in my EIP to measure and track results? 66

6.0 Elements ofAll Trading EIPs 73

6.1 What enforcement elements must all trading EIPs contain? 73

6.2 What provisions do I need in my trading EIP to address specific pollutant

effects? 76

6.3 What provisions do I need in my trading EIP to ensure it does not interfere

1
Electronic Filing, Received, Clerk"s Office, September 4, 2007

* * * * * R2008 008 * * * * *

~thotherprogrcrrns? 77

6.4 What provisions do I need in my trading EIP to address uncertainty? 79

6.5 What other provisions do I need in my trading EIP? 81

6.6 Are "emission reductions" the same as "emission reduction credits (ERCs)?" 87

7.0 Elements ofSpecific Trading EIPs 89

7.1 How do I select the appropriate trading EIP? 89

7.2 What other provisions do I need for my emission averaging EIP ? 91

7.3 What additional provisions do I need for my source-specific emission cap EIP? 94

7.4 What additional provisions do I need for my multi-source emission cap-and-trade EIP? 98

7.5 What additional provisions do I need for my open-market trading EIP? 105

8.0 Elements ofFinancial Mechanism EIPs 113

8.1 What provisions must all financial mechanism EIPs contain? 113

9.0 Elements ofClean Air Investment Funds 117

9.1 Why should I establish a CAlF? 118

9.2 How does a CAlF work? 118

9.3 How do CAlFs compare to other EIPs? 121

9.4 Can I use a CAlF to address environmental justice concerns? 123

9.5 How do I establish and implement a CAlF? 123

9.6 What provisions must all CAlFs contain? 124

10.0 Elements ofPublic Information EIPs ...........•.............................. 129

10.1 What provisions must all public information progrcrrns contain? 130

10.2 Are "voluntary measures" progrcrrns different from EIPs? 131

Other Requirements for EIPs

11.0 Getting Your EIP Approved 135

11.2 What must I submit to demonstrate my EIP is complete? 135

11.3 What must I submit for approval ifmy trading progrcrrn involves more

than my State? 137

11.4 What must I submit for approval to show my EIP is consistent ~th other

applicable laws? 137

11.5 How long ~l it take to get my EIP submittal approved by the EPA? 138

11.6 What final actions can the EPA take on my EIP SIP submittal? 138

11.7 What does it mean ifthe EPA does not :fully approve my EIP? 139

11.8 What happens if! implement my EIP before the EPA approves it? 140

12.0 Running Your Approved EIP 141

12.1 What are my responsibilities for running my EIP once it is approved? 141

12.2 HowmustIenforcemyEIP? 141

n
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

12.3 How must I evaluate my EIP? 142

12.4 How must I reconcile any problems? 142

12.5 How must I update inventories? 143

Other Important Information You Need to Know

13.0 Additional Guidance That Applies to EIPs 147

13.1 What additional guidance must I use for specific EIPs? 147

14.0 Mobile Source Guidance You May Use Instead ofThis Guidance 149

14.1 What guidance may I use instead ofthe EIP guidance? 149

15.0 Special Terms You Need to Know 153

15.1 Glossary 153

15.2 List of acronyms 166

16.0 Appendices 171

16.1 Special Provisions for Areas Needing and Lacking Attainment 171

16.2 VOC EIPs involving hazardous air pollutants (HAPs) 175

16.3 Emission quantification protocols for OMT EIPs 188

16.4 Guidance on Voluntaty Emission Reduction Programs 199

16.5 Ensuring Adequate Public Participation 225

16.6 FLM Notification Requirements 229

16.7 Area-wide RACT provisions 231

16.8 Provisions for sources with Title V permits 232

16.9 Provisions for ozone inter-precursor trading 235

16.10 Provisions to ensure consistency with transportation conformity 238

16.11 Provisions for localized increases of criteria pollutant and precursor

emissions 240

16.12 Provisions for inter-credit trading 242

16.13 Provisions for EIPs that include RACT sources 243

16.14 Provisions for new source review and trading 246

16.15 Provisions for banking emission reductions 249

16.16 Provisions for geographic trading across jurisdictional boundaries 256

16.17 Safeguards for EIPs that allow the use of old emissions reductions 258

16.18 Provisions for opt-in sources 260

iii
Electronic Filing, Received, Clerk's Office, September 4, 2007

* * * * * R2008 008 * * * * *

List of Tables

Table 1.1: EPA Regional Air Division Directors 7

Table 3.1: Characteristics ofEIPs 18

Table 3.2: Which Sections ofthis Guidance Should I Read? 30

Table 4.1(a): Programmatic Integrity Elements 37

Table 4.1(b): Programmatic Integrity Element ofSmplus for Trading EIPs 38

Table 4.1(c): Programmatic Integrity Element ofSmplus for Other EIPs 38

Table 4.2(a): Source-Specific Integrity Elements 40

Table 4.2(b): Comparison ofSource-Specific Integrity Elements for Trading EIPs 42

Table 4.2(c): Comparison ofSource Specific Integrity Elements for Other EIPs 44

Table 4.3(a):General Equity Principle for Trading EIPs 47

Table 4.3(b): General Equity Principle for Other EIPs 47

Table 4.4(a): Environmental Justice Element for Trading EIPs 49

Table 4.4(b): Environmental Justice Element for Other EIPs 49

Table 4.5(a): Environmental Benefit Principle for Trading EIPs 51

Table 4.5(b): Environmental Benefit Principle for Other EIPs 51

Table 7.1: Characteristics ofTrading EIPs 90

Table 10.1: Examples ofPublic Infonnation EIPs 130

Table 16.11: Significant Annual Increases for Criteria Pollutants 240

Table 16.14: NSR Requirements 247

IV
r' ZIEPA ATTACHMENT NO~_

ILLINOIS POLLUTION CONTROL BOARD

October 4, 2007

IN THE MATTER OF: )

)

ABBOTT LABORATORIES' PROPOSED )

SITE SPECIFIC AMENDMENT TO )

APPLICABILITY SECTION OF ORGANIC )

MATERIAL EMISSION STANDARDS AND )

LIMITATIONS FOR THE CHICAGO AREA;)

SUBPARTT: PHARMACEUTICAL )

MANUFACTURING (35 ILL. ADM. CODE )

218.480(b)) )

Proposed Rule. First Notice.

R08-8

(Rulemaking -Air)

OPINION AND ORDER OF THE BOARD (by N. J. Melas):

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

rulemaking pursuant to Section 28 ofEnvironmental Protection Act (Act) (415 ILCS 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 located in Libertyville

Township, Lake County. Abbott also filed motions requesting the Board to waive the

requirement for 200 signatures on its petition and to expedite consideration ofits request by,

among other things, ordering immediate publication ofthe rules for first notice under the Illinois

Administrative Procedure Act (APA) (5 ILCS 100/1-1)(2006). See, respectively, 35 Ill. Adm.

Code Sections 102.202(g) and 101.512. To date, the Board has received no response to either

motion from the Illinois Environmental Protection Agency (Agency) or any other person.

In this order, the Board accepts the proposal for hearing, granting the motion to waive

signature requirement. The Board denies the motion for expedited consideration, but authorizes

first-notice publication ofthe proposal without comment on the proposal's merits.

THE PROPOSAL

Abbott owns a pharmaceutical manufacturing facility located in Libertyville Township,

Lake County, Illinois ("the Facility"). Abbott's operations are subject to 35 Ill. Adm. Code,

Subpart T - Pharmaceutical Manufacturing ("Subpart T"). As currently written, Subpart T,

Section 218.480(b) ("Section 218.480(b)") contains certain exemptions that are only applicable

to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located

at the Facility. Abbott is proposing to amend these site-specific exemptions by "capping" and

lowering the overall emissions allowable under the exemptions from its tunnel dryers numbered

#1, #2, #3 and #4, and fluid bed dryers numbered #1, #2 and #3, and calculating the amount of

exempted emissions from the dryers based on the actual combined emissions from the dryers.

Abbott believes that, if adopted, the proposed amendment would reduce the overall allowable
2

emissions from these units while increasing Abbott's operational flexibility, by allowing it to

make preferential use ofthe more efficient fluid bed dryers.

MOTIONS

Abbott first requests that the Board waive the requirement for 200 signatures on the

petition, as required by 35 111. Adm. Code Section 102.202(g). In support ofthis motion, Abbott

cites various past proceedings in which the Board has granted similar requests.

In its motion to expedite (Mot. Exp.),Abbott also requests that the Board proceed to APA

first notice without reaching a decision on the merits, by accepting the regulatory language

proposed by Abbott in this rulemaking proposal only for purposes offirst notice. Abbott also

requests that the requisite hearing be scheduled as soon as possible in accordance with Section

28(a) ofthe Act. Mot. Exp. at 2-3.

In support ofthis request, Abbott asserts that the proposal is intended to increase

efficiency in its use of certain fluidized bed and tunnel dryers while providing for lower

allowable emissions from these dryers as a group. Abbot contends that the current rule "requires

Abbott to utilize its equipment and resources in a manner that is inefficient ... [causing] material

prejudice to Abbott." Mot. Exp. at 2. Abbott states that the Agency has been contacted and has

no disagreement with the proposed amendments. Abbott also cites to other proceedings in which

the Board has granted similar requests. Abbott also states that ifmore information is needed that

it will expeditiously provide it. Id. at 3.

DISCUSSION

First, the Board finds that the petition meets the content requirements of 35 Ill. Adm.

Code 102.208 and 102.210 and is accepted for hearing. However, a review ofthe proposal

reveals that Abbott did not address the applicability of, or provide the information requested in,

the "published study or report" requirement ofSection 102.210(c). 35 Ill. Adm. Code

102.210(c); see also 35 Ill. Adm. Code 102.210(g). The Board requests that Abbott address

Section 102.21O(c), or its inapplicability, in writing, prior to any hearing scheduled in this

proceeding or at such other time as directed by the hearing officer.

Next, the Board grants the motion to waive the signature requirement of Section

102.202(g).

Lastly, the Board denies the motion for expedited consideration. Requests for expedited

review are governed by Section 101.512 ofthe Board's rules, and must contain, inter alia, a

complete statement ofthe facts and reasons for the request. See 35 Ill. Adm. Code 101.512. In

acting on a motion for expedited review, the Board considers, at aminimum, all statutory

requirements and whether or not material prejudice will result from the motion being granted or

denied. 35 Ill. Adm. Code 101.512(b). In addition, the Board will only grant a motion for

expedited review consistent with available resources. See 35 Ill. Adm. Code 101.512(c).
r

3

The Board does not discount Abbott's assertions that continued operations using less

efficient drying processes is not optimal, and for the purposes ofthis motion accepts as true

Abbott's assertions that actual emissions would be lowered ifit operates under an amended rule

as proposed. However, this does not give rise to "material prejudice" sufficient to allow the

Board to grant Abbott's request as made.

As noted, expedited review is granted consistent with decision deadlines and available

resources. The Board currently has numerous open rulemaking dockets that demand immediate

attention, as well as pressing cases that will keep the Board busy for several months.

Due to attrition, Board staffing is at its lowest levels in some years. Even ifthe Board

were to accept that Abbott's claims amount to "material prejudice", the Board's limited

resources in light ofits current and future decision deadlines render the granting of a motion for

expedited review unlikely in all but the most dire circumstances.

However, the Board can authorize the first-notice publication ofthis proposal without

comment on its merits. The Board notes that it has made minor, non-substantive changes to the

text ofthe propoqed rule. The Board directs its hearing officer to expeditiously schedule hearing

consistent with the Board's decision calendar and operational needs.

The Board directs the Clerk to cause first-notice publication in the Illinois Register ofthe

following proposed rule:

TITLE 35: ENVIRONMENTAL PROTECTION

SUBTITLE B: AIR POLLUTION

CHAPTER I: POLLUTION CONTROL BOARD

SUBCHAPTER c: EMISSIONS STANDARDS AND

LIMITATIONS FOR STATIONARY SOURCES

PART 218

ORGANIC MATERIAL EMISSION STANDARDS AND

LIMITATIONS FOR THE CHICAGO AREA

SUBPART A: GENERAL PROVISIONS

Section

218.100

218.101

218.102

218.103

218.104

218.105

218.106

218.107

218.108

Introduction

Savings Clause

Abbreviations and Conversion Factors

Applicability

Definitions."," .

Test Methods and Procedures

Compliance Dates

Operation ofAfterburners

Exemptions, Variations, and Alternative Means ofControl or Compliance

Determinations
218.109

218.110

218.111

218.112

218.113

218.114

Section

218.119

218.120

218.121

218.122

218.123

218.124

218.125

218.126

218.127

218.128

218.129

Section

218.141

218.142

218.143

218.144

Section

218.181

218.182

218.183

218.184

218.185

218.186

Section

218.204

218.205

218.206

218.207

218.208

4

Vapor Pressure ofVolatile Organic Liquids

Vapor Pressure of Organic Material or Solvent

Vapor Pressure ofVolatile Organic Material

Incorporations by Reference

Monitoring for Negligibly-Reactive Compounds

Compliance with Permit Conditions

SUBPART B: ORGANIC EMISSIONS FROM STORAGE AND LOADING

OPERATIONS

Applicability for VOL

Control Requirements for Storage Containers ofVOL

Storage Containers ofVPL

Loading Operations

Petroleum Liquid Storage Tanks

External Floating Roofs

Compliance Dates

Compliance Plan (Repealed)

Testing VOL Operations

Monitoring VOL Operations

Recordkeeping and Reporting for VOL Operations

SUBPART C: ORGANIC EMISSIONS FROM MISCELLANEOUS

EQUIPMENT

Separation Operations

Pumps and Compressors

Vapor Blowdown

Safety Relief Valves

SUBPARTE: SOLVENT CLEANING

Solvent Cleaning in General

Cold Cleaning

Open Top Vapor Degreasing

Conveyorized Degreasing

Compliance Schedule (Repealed)

Test Methods

SUBPART F: COATING OPERATIONS

Emission Limitations

Daily-Weighted Average Limitations

Solids Basis Calculation

Alternative Emission Limitations

Exemptions from Emission Limitations
218.209

218.210

218.211

218.212

218.213

218.214

218.215

218.216

218.217

Section

218.301

218.302

218.303

218.304

Section

218.401

218.402

218.403

218.404

218.405

218.406

218.407

218.408

218.409

218.410

218.411

Section

218.421

218.422

218.423

218.424

218.425

218.426

218.427

218.428

218.429

5

Exemption from General Rule on Use ofOrganic Material

Compliance Schedule

Recordkeeping and Reporting

Cross-Line Averaging to Establish Compliance for Coating Lines

Recordkeeping and Reporting for Cross-Line Averaging Participating Coating

Lines

Changing Compliance Methods

Wood Furniture Coating Averaging Approach

Wood Furniture Coating Add-On Control Use

Wood Furniture Coating Work Practice Standards

SUBPART G: USE OF ORGANIC MATERIAL

Use ofOrganic Material

Alternative Standard

Fuel Combustion Emission Units

Operations with Compliance Program

SUBPART H: PRINTING AND PUBLISHING

Flexographic and Rotogravure Printing

Applicability

Compliance Schedule

Recordkeeping and Reporting

Lithographic Printing: Applicability

Provisions Applying to Heatset Web Offset Lithographic Printing Prior to March

15, 1996

Emission Limitations and Control Requirements for Lithographic Printing Lines

On and After March 15, 1996

Compliance Schedule for Lithographic Printing On and After March 15, 1996

Testing for Lithographic Printing On and After March 15, 1996

Monitoring Requirements for Lithographic Printing

Recordkeeping and Reporting for Lithographic Printing

SUBPART Q: SYNTHETIC ORGANIC CHEMICAL AND POLYMER

MANUFACTURING PLANT

General Requirements

Inspection Program Plan for Leaks

Inspection Program for Leaks

Repairing Leaks

Recordkeeping for Leaks

Report for Leaks

Alternative Program for Leaks

Open-Ended Valves

Standards for Control Devices
218.430

218.431

218.432

218.433

218.434

218.435

218.436

Section

218.441

218.442

218.443

218.444

218.445

218.446

218.447

218.448

218.449

218.450

218.451

218.452

218.453

Section

218.461

218.462

218.463

218.464

218.465

218.466

Section

218.480

218.481

218.482

218.483

218.484

218.485

218.486

218.487

218.488

6

Compliance Date (Repealed)

Applicability

Control Requrrements

Performance and Testing Requirements

Monitoring Requirements

Recordkeeping and Reporting Requirements

Compliance Date

SUBPART R: PETROLEUM REFINING AND RELATED INDUSTRIES;

ASPHALT MATERIALS

Petroleum Refinery Waste Gas Disposal

Vacuum Producing Systems

Wastewater (Oil/Water) Separator

Process Unit Turnarounds

Leaks: General Requirements

Monitoring Program Plan for Leaks

Monitoring Program for Leaks

Recordkeeping for Leaks

Reporting for Leaks

Alternative Program for Leaks

Sealing Device Requirements

Compliance Schedule for Leaks

Compliance Dates (Repealed)

SUBPART S: RUBBER AND MISCELLANEOUS PLASTIC PRODUCTS

Manufacture of Pneumatic Rubber Tires

Green Tire Spraying Operations

Alternative Emission Reduction Systems

Emission Testing

Compliance Dates (Repealed)

Compliance Plan (Repealed)

SUBPART T: PHARMACEUTICAL MANUFACTURING

Applicability

Control ofReactors, Distillation Units, Crystallizers, Centrifuges and Vacuum

Dryers

Control ofAir Dryers, Production Equipment Exhaust Systems and Filters

Material Storage and Transfer

In-Process Tanks

Leaks

Other Emission Units

Testing

Monitoring for Air Pollution Control Equipment
r

7

218.489 Recordkeeping for Air Pollution Control Equipment

Applicability for Batch Operations

Control Requirements for Batch Operations

Determination ofUncontrolled Total Annual Mass Emissions and Average Flow

Rate Values for Batch Operations

Performance and Testing Requirements for Batch Operations

Monitoring Requirements for Batch Operations

Reporting and Recordkeeping for Batch Operations

Compliance Date

Emission Limitations for Air Oxidation Processes

Definitions (Repealed)

Savings Clause

Compliance

Determination ofApplicability

Emission Limitations for Air Oxidation Processes

Testing and Monitoring

Compliance Date (Repealed)

218.503

218.504

218.505

218.506

218.520

218.521

218.522

218.523

218.524

218.525

218.526

218.527

SUBPART V: BATCH OPERATIONS AND AIR OXIDATION PROCESSES

Section

218.500

218.501

218.502

SUBPART W: AGRICULTURE

Section

218.541 Pesticide Exception

SUBPART X: CONSTRUCTION

Section

218.561

218.562

218.563

Architectural Coatings

Paving Operations

Cutback Asphalt

SUBPART Y: GASOLINE DISTRIBUTION

Section

218.581

218.582

218.583

218.584

218.585

218.586

Bulk Gasoline Plants

Bulk Gasoline Terminals

Gasoline Dispensing Operations - Storage Tank Filling Operations

Gasoline Delivery Vessels

Gasoline Volatility Standards

Gasoline Dispensing Operations - Motor Vehicle Fueling Operations

SUBPART Z: DRY CLEANERS

Section

218.601

218.602

218.603

218.604

Perchloroethy1ene Dry Cleaners (Repealed)

Applicability (Repealed)

Leaks (Repealed)

Compliance Dates (Repealed)
218.605

218.606

218.607

218.608

218.609

218.610

218.611

218.612

218.613

Section

218.620

218.621

218.623

218.624

218.625

218.626

218.628

218.630

218.636

218.637

Section

218.640

218.642

218.644

Section

218.660

218.666

218.667

218.668

218.670

218.672

Section

218.680

218.686

218.688

218.690

218.692

8

Compliance Plan (Repealed)

Exception to Compliance Plan (Repealed)

Standards for Petroleum Solvent Dry Cleaners

Operating Practices for Petroleum Solvent Dry Cleaners

Program for Inspection and Repair ofLeaks

Testing and Monitoring

Applicability for Petroleum Solvent Dry Cleaners

Compliance Dates (Repealed)

Compliance Plan (Repealed)

SUBPART AA: PAINT AND INK MANUFACTURING

Applicability

Exemption for Waterbase Material and Heatset Offset Ink

Permit Conditions (Repealed)

Open Top Mills, Tanks, Vats or Vessels

Grinding Mills

Storage Tanks

Leaks

Clean Up

Compliance Schedule

Recordkeeping and Reporting

SUBPART BB: POLYSTYRENE PLANTS

Applicability

Emissions Limitation at Polystyrene Plants

Emissions Testing

SUBPART CC: POLYESTER RESIN PRODUCT MANUFACTURING

PROCESS

Applicability

Control Requirements

Compliance Schedule

Testing

Recordkeeping and Reporting for Exempt Emission Units

Recordkeeping and Reporting for Subject Emission Units

SUBPART DD: AEROSOL CAN FILLING

Applicability

Control Requirements

Testing

Recordkeeping and Reporting for Exempt Emission Units

Recordkeeping and Reporting for Subject Emission Units
Section

218.720

218.722

218.726

218.727

218.728

218.729

218.730

Section

218.760

218.762

218.764

218.766

218.768

218.770

Section

218.780

218.782

218.784

218.786

218.787

218.788

218.789

218.790

218.791

218.792

218.875

218.877

218.879

218.881

218.883

218.886

Section

218.920

218.923

218.926

218.927

9

SUBPART FF: BAKERY OVENS (REPEALED)

Applicability (Repealed)

Control Requirements (Repealed)

Testing (Repealed)

Monitoring (Repealed)

Recordkeeping and Reporting (Repealed)

Compliance Date (Repealed)

Certification (Repealed)

SUBPART GG: MARINE TERMINALS

Applicability

Control Requirements

Compliance Certification

Leaks

Testing and Monitoring

Recordkeeping and Reporting

SUBPART HH: MOTOR VEHICLE REFINISHING

Emission Limitations

Alternative Control Requirements

Equipment Specifications

Surface Preparation Materials

Work Practices

Testing

Monitoring and Recordkeeping for Control Devices

General Recordkeeping and Reporting (Repealed)

Compliance Date

Registration

Applicability of Subpart BB (Renumbered)

Emissions Limitation at Polystyrene Plants (Renumbered)

Compliance Date (Repealed)

Compliance Plan (Repealed)

Special Requirements for Compliance Plan (Repealed)

Emissions Testing (Renumbered)

SUBPART PP: MISCELLANEOUS FABRICATED PRODUCT

MANUFACTURING PROCESSES

Applicability

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule
218.928

218.929

Section

218.940

218.943

218.946

218.947

218.948

Section

218.960

218.963

218.966

218.967

218.968

Section

218.980

218.983

218.986

218.987

218.988

Section

218.990

218.991

10

Testing

Cementable and Dress or Performance Shoe Leather

SUBPART QQ: MISCELLANEOUS FORMULATION MANUFACTURING

PROCESSES

Applicability

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Testing

SUBPART RR: MISCELLANEOUS ORGANIC CHEMICAL

MANUFACTURING PROCESSES

Applicability

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Testing

SUBPART TT: OTHER EMISSION UNITS

Applicability

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Testing

SUBPART UU: RECORDKEEPING AND REPORTING

Exempt Emission Units

Subject Emission Units

2l8.APPENDIX A:

2l8.APPENDIX B:

2l8.APPENDIX C:

2l8.APPENDIX D:

2l8.APPENDIX E:

2l8.APPENDIX G:

2l8.APPENDIX H:

List ofChemicals Defining Synthetic Organic Chemical and

Polymer Manufacturing

YOM Measurement Techniques for Capture Efficiency (Repealed)

Reference Methods and Procedures

Coefficients for the Total Resource Effectiveness Index (TRE)

Equation

List ofAffected Marine Terminals

TRE Index Measurements for SOCMI Reactors and Distillation

Units

Baseline YOM Content Limitations for Subpart F, Section 218.212

Cross-Line Averaging
11

AUTHORITY: Implementing Section 10 and authorized by Sections 27,28,28.5 ofthe

Environmental Protection Act [415 ILCS 5110 and 28.5].

SOURCE: Adopted at R91-7 at 15 Ill. Reg. 12231, effective August 16, 1991; amended in R91-

24 at 16 Ill. Reg. 13564, effective August 24, 1992; amended in R91-28 and R91-30 at 16 Ill.

Reg. 13864, effective August 24, 1992; amended in R93-9 at 17 Ill. Reg. 16636, effective

September 27, 1993; amended in R93-14 at 18 Ill. Reg. at 1945, effective January 24, 1994;

amended in R94-12 at 18 Ill. Reg. 14973, effective September 21, 1994; amended in R94-15 at

18 Ill. Reg. 16392, effective October 25, 1994; amended in R94-16 at 18 Ill. Reg. 16950,

effective November 15, 1994; amended in R94-21 , R94-31 and R94-32 at 19 Ill. Reg. 6848,

effective May 9, 1995; amended in R94-33 at 19 Ill. Reg. 7359, effective May 22, 1995;

amended in R96-13 at 20 Ill. Reg. 14428, effective October 17, 1996; amended in R97-24 at 21

Ill. Reg. 7708, effective June 9, 1997; amended in R97-31 at 22 Ill. Reg. 3556, effective

February 2, 1998; amended in R98-16 at 22 Ill. Reg. 14282, effective July 16, 1998; amended in

R02-20 at 27 Ill. Reg. 7283, effective April 8, 2003; amended in R04-12/20 at 30 Ill. Reg. 9684,

effective May 15,2006; amended in R06-21 at 31 Ill. Reg. 7086, effective April 30, 2007;

amended in R08-8 at 31 Ill. Reg. , effective _

SUBPART T: PHARMACEUTICAL MANUFACTURING

Section 218.480 Applicability

a) The rules ofthis Subpart, except for Sections 218.483 through 218.485 ofthis

Part, apply to all emission units ofVOM, including but not limited to reactors,

distillation units, dryers, storage tanks for VOL, equipment for the transfer of

VOL, filters, crystallizers, washers, laboratory hoods, pharmaceutical coating

operations, mixing operations and centrifuges used in manufacturing, including

packaging, ofpharmaceuticals, and emitting more than 6.8 kg/day (15 lbs/day)

and more than 2,268 kg/year (2.5 tons/year) ofVOM. Ifsuch an emission unit

emits less than 2,268 kg/year (2.5 tons/year) ofVOM, the requirements ofthis

Subpart still apply to the emission unit if YOM emissions from the emission unit

exceed 45.4 kg/day (100 lbs/day).

b) Notwithstanding subsection (a) ofthis Section, the air suspension coater/dryer,

fluid bed dryers, tunnel dryers, and Accelacotas located in Libertyville Township,

Lake County, Illinois shall be exempt from the rules ofthis Subpart, except for

Sections 218.483 through 218.485, if emissions ofVOM not vented to air

pollution control equipment do not exceed the following levels:

1) For the air suspension coater/dryer: 2,268 kg/year (2.5 tons/year);

2) Except as set forth in subsection 218.480(b)(4) ofthis Section, forffi

each fluid bed dryer: 4,535 kg/year (5.0 tons/year);
12

3) Except as set forth in subsection 218.480(b)(4) ofthis Section, for Fef

each tunnel dryer: 6,803 kg/year (7.5 tons/year); and

1} For fluid bed dryers #1, #2, and #3 and for tunnel dryers #1, #2, #3, and

#4, the combined total annual emissions from the dryers listed in this

subsection 218.480(b)(4) shall not exceed 18,779 kg/year (20.7 tons/year).

[BOARD NOTE: tunnel dryers are otherwise referred to as warm air

dryers]; and

4~) For each Accelacota: 6,803 kg/year (7.5 tons/year).

c) Sections 218.483 through 218.485 ofthis Part apply to a source having one or

more emission units that:

1) Are used to manufacture pharmaceuticals, and

2) Emit more than 6.8 kg/day (151bs/day) ofVOM and more than 2,268

kg/year (2.5 tons/year) ofVOM, or, ifless than 2,268 kg/year (2.5

tons/year), these Sections still apply if emissions from one or more sources

exceed 45.4 kg/day (100 Ibs/day).

d) No owner or operator shall violate any condition in a permit when the condition

results in exclusion of an emission unit from this Subpart.

e) Any pharmaceutical manufacturing source that becomes subject to the provisions

ofthis Subpart at any time shall remain subject to the provisions ofthis Subpart at

all times.

f) Emissions subject to this Subpart shall be controlled at all times consistent with

the requirements set forth in this Subpart.

g) Any control device required pursuant to this Subpart shall be operated at all times

when the source it is controlling is operated.

h) Determinations of daily and annual emissions for purposes ofthis Section shall be

made using both data on the hourly emission rate (or the emissions per unit of

throughput) and appropriate daily and annual data from records of emission unit

operation (or material throughput or material consumption data). In the absence

ofrepresentative test data pursuant to Section 218.487 ofthis Part for the hourly

emission rate (or the emissions per unit ofthroughput) such items shall be

calculated using engineering calculations, including the methods described in

Appendix B of "Control ofVolatile Organic Emissions from Manufacturing of

Synthesized Pharmaceutical Products" (EPA-450/2-78-029), incorporated by

reference in Section 218.112 ofthis Part. (This subsection shall not affect the

Agency's or the USEPA's authority to require emission tests to be performed

pursuant to Section 218.487 ofthis Part.)
13

i) Equipment and operations emitting YOM at a source subject to subsection (a) or

(c) ofthis Section and used to produce pharmaceutical products or a

pharmaceutical-like product such as a hormone, enzyme, or antibiotic, shall be

deemed to be engaged in the manufacture ofpharmaceuticals for the purposes of

this Subpart.

(Source: Amended at 31 Ill. Reg. , effective --')

IT IS SO ORDERED.

Member A. S. Moore abstained.

I, John T. Therriault, Assistant Clerk ofthe Illinois Pollution Control Board, certify that

the Board adopted the above order on October 4,2007, by a vote of3-0.

John T. Therriault, Assistant Clerk

Illinois Pollution Control Board
Dear Director Lavin:

ILLINOIS POLLUTION CONTROL BOARD

tEPA ATTACHMENT NO.

RBcml D

OlERK'SO

OCT 182007

STATE OF ILLINOIS

Pollution Control Board

October 18,2007

Jack Lavin, Director

Department of Commerce and Economic Opportunity

620 East Adams Street, S-6

Springfield, lllinois 62704

Re: Request for Economic Impact Study for: 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)

In response to Abbott's request, the Board accepted the proposal for hearing,

and frrst notice publication, but did not comment on the merits ofthe Abbott

proposal. As Abbott would like a decision on the request as soon as possible, the

Board is in the process ofscheduling a hearing in the near future.

On October 4, 2007, the Board accepted a proposal for hearing in 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 TIL Adm. Code 218.480(b» (R08-8). I am

writing to request that your Department conduct an economic impact study

concerning this site-specific proposal. The rulemaking is based on a proposal filed

by Abbott Laboratories to amend the Board's air regulations. The Board is in the

process of scheduling hearings in this rulemaking.

Abbott Laboratories proposed these site-specific amendments for its

pharmaceutical manufacturing facility located in Libertyville Township, Lake

County. 35 lil. Adm. Code 218.480(b) contains certain exemptions that are only

applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel dryers,

and Accelacotas. Abbott is proposing to amend these site-specific exemptions by

"capping" and lowering the overall emissions allowable under the exemptions from

its tunnel dryers numbered #1, #2, #3 and #4, and fluid bed dryers numbered #1, #2

and #3, and calculating the amount of exempted emissions from the dryers based on

the actual combined emissions from the dryers. Abbott believes that, if adopted, the

proposed amendment would reduce the overall allowable emissions from these units

while increasing Abbott's operational flexibility, by allowing it to make preferential

use ofthe more efficient fluid bed dryers.

r
ILLINOIS POLLUTION CONTROL BOARD

Since 1998, Section 27 (b) of the Environmental Protection Act has required

the Board to:

1) "request that the Department of Commerce and Economic Opportunity

(fonnerly the Department of Commerce and Community Affairs) conduct a

study ofthe economic impact of the proposed rules. The Department may

within 30 to 45 days ofsuch request produce a study ofthe economic impact

of the proposed rules. At a minimum, the economic impact study shall

address a) economic, environmental, and public health benefits that may be

achieved through compliance with the proposed rules, b) the effects of the

proposed rules on employment levels, commercial productivity, the economic

growth ofsmall businesses with 100 or less employees, and the State's

overall economy, and c) the cost per unit of pollution reduced and the

variability of company revenues expected to be used to implement the

proposed rules; and

(2) conduct at least one public hearing on the economic impact of those

rules. At least 20 days before the hearing, the Board shall notify the public of

the hearing and make the economic impact study, or the Department of

Commerce and Economic Opportunity's explanation for not producing an

economic impact study, available to the public. Such public hearing may be

held simultaneously or as a part of any Board hearing considering such new

rules'" 415 ILCS 5/27(b) (2004).

IfI, or my staff, can provide you with any additional information, please let

me know.

Thank you in advance for your prompt response.

Sincerely,

))...,~fiI~

G. Tanner Girard

Acting Chairman

Pollution Control Board

cc: Warren Ribley, DCEO

John T. Therriault, AssistantClerk ofthe Board
IEPA ATTACHMENT NO....:i.

RECEIVED

CLERK'S OFFICE

OCT 1. 'l 2007

STATE OF ILliNOIS

Pollution control Board

OFFICE OF THE SECRETARY OF STATE

JESSE WHITE. Secretary of State

10/17/2007

POLLUTION CONTROL BOARD

JAMES R THOMPSON CENTER 100 W RANDOLPH ST STE 11-500

DOROTHY GUNN

CHICAGO, IL 60601

Dear DOROTHY GUNN

Your rules Listed below met our codification standards and have been published in

Volume 31, Issue 43 of the Illinois Register, dated 10/26/2007.

PROPOSED RULES

Organic Material Emission Standards and Limitations for the Chicago Area

35 III. Adm. Code 218

Point Of Contact:Erin Conley

Page 14581

If you have any questions, you may contact the Administrative Code Division at

(217) 782 - 7017.

Index Department - Administrative Code Division - 111 East Monroe Springfield, IL 62756
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

1) Heading ofthe Part: Organic Material Emission Standards and Limitations for the

Chicago Area

2) Code Citation: 35 Ill. Adm. Code Part 218

3) Section Numbers:

218,480

Proposed Action:

Amend

4) Statutory Authority: Implementing Section 10 and authorized by Sections 27 and 28 of

the Environmental Protection Act [415 ILCS 5/10,27 and 28]

5) A Complete Description ofthe Subjects and Issues Involved:

For a more detailed discussion ofthese amendments, see the Board's October 4, 2007

opinion and order in docket R08-8: 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). Abbott Laboratories proposed site-specific

amendments for its pharmaceutical manufacturing facility located in Libertyville

Township, Lake County. 35 Ill. Adm. Code 218,480(b) contains certain exemptions that

are only applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel

dryers, and Accelacotas. Abbott is proposing to amend these site-specific exemptions by

"capping" and lowering the overall emissions allowable under the exemptions from its

tunnel dryers numbered #1, #2, #3 and #4, and fluid bed dryers numbered #1, #2 and #3,

and calculating the amount of exempted emissions from the dryers based on the actual

combined emissions from the dryers. Abbott believes that, if adopted, the proposed

amendment would reduce the overall allowable emissions from these units while

increasing Abbott's operational flexibility, by allowing it to make preferential use ofthe

more efficient fluid bed dryers.

In response to Abbott's request, the Board accepted the proposal for hearing, and first

notice publication, but does not comment on the merits ofthe Abbott proposal.

6) Published studies or reports. and sources of underlying data. used to compose this

rulemaking: None presently identified.

7) Will this proposed rulemaking replace an emergency rule currently in effect? No

8) Does this rulemaking contain an automatic repeal date? No

RECEIVED

OCT 152007

50S-CODE DIV.
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

9) Does this proposed rulemaking contain incorporations by reference? No

10) Are there any other proposed amendments pending on this Part? No

11) Statement of Statewide Policy Objectives: This proposed rule does not create or enlarge

a State mandate, as defined in Section 3(b) ofthe State Mandates Act. [30 ILCS 805/3(b)

(2006)]

12) Time, Place, and Manner in which interested persons may comment on this proposed

rulemaking:

The Board is in the process ofscheduling a hearing in the rulemaking. Additionally, the

Board will accept written public comment on this proposal for 45 days after the date of

publication in the Illinois Register. Comments should reference Docket R08-8 and be

addressed to:

Clerk's Office

Illinois Pollution Control Board

100 W. Randolph St., Suite 11-500

Chicago, IL 60601

Interested persons may request copies ofthe Board's opinion and order by calling the

Clerk's office at 312-814-3620, or may download copies from the Board's Web site at

www.ipcb.state.il.us.

For more information, contact hearing officer Kathleen M. Crowley at 312/814-6929 or

email atcrowlek@ipcb.state.il.us.

13) Initial Regulatory Flexibility Analysis:

A) Types ofsmall businesses, small municipalities and not for profit corporations

affected: This proposed rulemaking is site specific and will only impact Abbott

Laboratories.

B) Reporting, bookkeeping or other procedures required for compliance:

This rulemaking does not impose any additional reporting or recordkeeping

requirements.

C) Types ofProfessional skills necessary for compliance: No professional skills

beyond those currently required by the existing state and federal air pollution

control regulations applicable to affected source will be required.
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

14) Reason this rulemaking was not included in the two most recent regulatory agendas:

The Board did not anticipate that Abbott Laboratories would request this site-specific

relief.

The full text ofthe Proposed Amendment begins on the next page:
Section

218.100

218.101

218.102

218.103

218.104

218.105

218.106

218.107

218.108

218.109

218.110

218.111

218.112

218.113

218.114

Section

218.119

218.120

218.121

218.122

218.123

218.124

218.125

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

TITLE 35: ENVIRONMENTAL PROTECTION

SUBTITLE B: AIR POLLUTION

CHAPTER I: POLLUTION CONTROL BOARD

SUBCHAPTER c: EMISSIONS STANDARDS AND

LIMITATIONS FOR STATIONARY SOURCES

PART 218

ORGANIC MATERIAL EMISSION STANDARDS AND

LIMITATIONS FOR THE CHICAGO AREA

SUBPART A: GENERAL PROVISIONS

Introduction

Savings Clause

Abbreviations and Conversion Factors

Applicability

Definitions

Test Methods and Procedures

Compliance Dates

Operation ofAfterburners

Exemptions, Variations, and Alternative Means ofControl or Compliance

Determinations

Vapor Pressure ofVolatile Organic Liquids

Vapor Pressure of Organic Material or Solvent

Vapor Pressure ofVolatile Organic Material

Incorporations by Reference

Monitoring for Negligibly-Reactive Compounds

Compliance with Permit Conditions

SUBPART B: ORGANIC EMISSIONS FROM STORAGE AND LOADING

OPERATIONS

Applicability for VOL

Control Requirements for Storage Containers ofVOL

Storage Containers ofVPL

Loading Operations

Petroleum Liquid Storage Tanks

External Floating Roofs

Compliance Dates
218.126

218.127

218.128

218.129

Section

218.141

218.142

218.143

218.144

Section

218.181

218.182

218.183

218.184

218.185

218.186

Section

218.204

218.205

218.206

218.207

218.208

218.209

218.210

218.211

218.212

218.213

218.214

218.215

218.216

218.217

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

Compliance Plan (Repealed)

Testing VOL Operations

Monitoring VOL Operations

Recordkeeping and Reporting for VOL Operations

SUBPART C: ORGANIC EMISSIONS FROM MISCELLANEOUS

EQUIPMENT

Separation Operations

Pumps and Compressors

Vapor Blowdown

Safety Relief Valves

SUBPART E: SOLVENT CLEANING

Solvent Cleaning in General

Cold Cleaning

Open Top Vapor Degreasing

Conveyorized Degreasing

Compliance Schedule (Repealed)

Test Methods

SUBPART F: COATING OPERATIONS

Emission Limitations

Daily-Weighted Average Limitations

Solids Basis Calculation

Alternative Emission Limitations

Exemptions from Emission Limitations

Exemption from General Rule on Use ofOrganic Material

Compliance Schedule

Recordkeeping and Reporting

Cross-Line Averaging to Establish Compliance for Coating Lines

Recordkeeping and Reporting for Cross-Line Averaging Participating Coating

Lines

Changing Compliance Methods

Wood Furniture Coating Averaging Approach

Wood Furniture Coating Add-On Control Use

Wood Furniture Coating Work Practice Standards
Section

218.301

218.302

218.303

218.304

Section

218.401

218.402

218.403

218.404

218.405

218.406

218.407

218.408

218.409

218.410

218.411

Section

218.421

218.422

218.423

218.424

218.425

218.426

218.427

218.428

218.429

218.430

218.431

218.432

218.433

218.434

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

SUBPART G: USE OF ORGANIC MATERIAL

Use ofOrganic Material

Alternative Standard

Fuel Combustion Emission Units

Operations with Compliance Program

SUBPART H: PRINTING AND PUBLISHING

Flexographic and Rotogravure Printing

Applicability

Compliance Schedule

Recordkeeping and Reporting

Lithographic Printing: Applicability

Provisions Applying to Heatset Web Offset Lithographic Printing Prior to March

15,1996

Emission Limitations and Control Requirements for Lithographic Printing Lines

On and After March 15, 1996

Compliance Schedule for Lithographic Printing On and After March 15, 1996

Testing for Lithographic Printing On and After March 15, 1996

Monitoring Requirements for Lithographic Printing

Recordkeeping and Reporting for Lithographic Printing

SUBPART Q: SYNTHETIC ORGANIC CHEMICAL AND POLYMER

MANUFACTURING PLANT

General Requirements

Inspection Program Plan for Leaks

Inspection Program for Leaks

Repairing Leaks

Recordkeeping for Leaks

Report for Leaks

Alternative Program for Leaks

Open-Ended Valves

Standards for Control Devices

Compliance Date (Repealed)

Applicability

Control Requirements

Performance and Testing Requirements

Monitoring Requirements
218.435

218.436

Section

218.441

218.442

218.443

218.444

218.445

218.446

218.447

218.448

218.449

218.450

218.451

218.452

218.453

Section

218.461

218.462

218.463

218.464

218.465

218.466

Section

218.480

218.481

218.482

218.483

218.484

218.485

218.486

218.487

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

Recordkeeping and Reporting Requirements

Compliance Date

SUBPART R: PETROLEUM REFINING AND RELATED INDUSTRIES;

ASPHALT MATERIALS

Petroleum Refinery Waste Gas Disposal

Vacuum Producing Systems

Wastewater (Oil/Water) Separator

Process Unit Turnarounds

Leaks: General Requirements

Monitoring Program Plan for Leaks

Monitoring Program for Leaks

Recordkeeping for Leaks

Reporting for Leaks

Alternative Program for Leaks

Sealing Device Requirements

Compliance Schedule for Leaks

Compliance Dates (Repealed)

SUBPART S: RUBBER AND MISCELLANEOUS PLASTIC PRODUCTS

Manufacture ofPneumatic Rubber Tires

Green Tire Spraying Operations

Alternative Emission Reduction Systems

Emission Testing

Compliance Dates (Repealed)

Compliance Plan (Repealed)

SUBPART T: PHARMACEUTICAL MANUFACTURING

Applicability

Control ofReactors, Distillation Units, Crystallizers, Centrifuges and Vacuum

Dryers

Control ofAir Dryers, Production Equipment Exhaust Systems and Filters

Material Storage and Transfer

In-Process Tanks

Leaks

Other Emission Units

Testing
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

218.488

218.489

Monitoring for Air Pollution Control Equipment

Recordkeeping for Air Pollution Control Equipment

Applicability for Batch Operations

Control Requirements for Batch Operations

Determination ofUncontrolled Total Annual Mass Emissions and Average Flow

Rate Values for Batch Operations

Performance and Testing Requirements for Batch Operations

Monitoring Requirements for Batch Operations

Reporting and Recordkeeping for Batch Operations

Compliance Date

Emission Limitations for Air Oxidation Processes

Definitions (Repealed)

Savings Clause

Compliance

Determination ofApplicability

Emission Limitations for Air Oxidation Processes

Testing and Monitoring

Compliance Date (Repealed)

218.503

218.504

218.505

218.506

218.520

218.521

218.522

218.523

218.524

218.525

218.526

218.527

SUBPART V: BATCH OPERATIONS AND AIR OXIDATION PROCESSES

Section

218.500

218.501

218.502

SUBPART W: AGRICULTIJRE

Section

218.541 Pesticide Exception

SUBPART X: CONSTRUCTION

Section

218.561

218.562

218.563

Architectural Coatings

Paving Operations

Cutback Asphalt

SUBPART Y: GASOLINE DISTRIBUTION

Section

218.581

218.582

218.583

218.584

218.585

218.586

Bulk Gasoline Plants

Bulk Gasoline Terminals

Gasoline Dispensing Operations - Storage Tank Filling Operations

Gasoline Delivery Vessels

Gasoline Volatility Standards

Gasoline Dispensing Operations - Motor Vehicle Fueling Operations
Section

218.601

218.602

218.603

218.604

218.605

218.606

218.607

218.608

218,609

218.610

218.611

218.612

218.613

Section

218.620

218.621

218.623

218.624

218.625

218.626

218.628

218.630

218.636

218.637

Section

218.640

218.642

218.644

Section

218.660

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

SUBPART Z: DRY CLEANERS

Perchloroethylene Dry Cleaners (Repealed)

Applicability (Repealed)

Leaks (Repealed)

Compliance Dates (Repealed)

Compliance Plan (Repealed)

Exception to Compliance Plan (Repealed)

Standards for Petroleum Solvent Dry Cleaners

Operating Practices for Petroleum Solvent Dry Cleaners

Program for Inspection and Repair of Leaks

Testing and Monitoring

Applicability for Petroleum Solvent Dry Cleaners

Compliance Dates (Repealed)

Compliance Plan (Repealed)

SUBPART AA: PAINT AND INK MANUFACTURING

Applicability

Exemption for Waterbase Material and Heatset Offset Ink

Permit Conditions (Repealed)

Open Top Mills, Tanks, Vats or Vessels

Grinding Mills

Storage Tanks

Leaks

Clean Up

Compliance Schedule

Recordkeeping and Reporting

SUBPART BB: POLYSTYRENE PLANTS

Applicability

Emissions Limitation at Polystyrene Plants

Emissions Testing

SUBPART CC: POLYESTER RESIN PRODUCT MANUFACTURING

PROCESS

Applicability
218.666

218.667

218.668

218.670

218.672

Section

218.680

218.686

218.688

218.690

218.692

Section

218.720

218.722

218.726

218.727

218.728

218.729

218.730

Section

218.760

218.762

218.764

218.766

218.768

218.770

Section

218.780

218.782

218.784

218.786

218.787

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

Control Requirements

Compliance Schedule

Testing

Recordkeeping and Reporting for Exempt Emission Units

Recordkeeping and Reporting for Subject Emission Units

SUBPART DD: AEROSOL CAN FILLING

Applicability

Control Requirements

Testing

Recordkeeping and Reporting for Exempt Emission Units

Recordkeeping and Reporting for Subject Emission Units

SUBPART FF: BAKERY OVENS (REPEALED)

Applicability (Repealed)

Control Requirements (Repealed)

Testing (Repealed)

Monitoring (Repealed)

Recordkeeping and Reporting (Repealed)

Compliance Date (Repealed)

Certification (Repealed)

SUBPART GG: MARINE TERMINALS

Applicability

Control Requirements

Compliance Certification

Leaks

Testing and Monitoring

Recordkeeping and Reporting

SUBPART HH: MOTOR VEHICLE REFINISHING

Emission Limitations

Alternative Control Requirements

Equipment Specifications

Surface Preparation Materials

Work Practices
218.788

218.789

218.790

218.791

218.792

218.875

218.877

218.879

218.881

218.883

218.886

Section

218.920

218.923

218.926

218.927

218.928

218.929

Section

218.940

218.943

218.946

218.947

218.948

Section

218.960

218.963

218.966

218.967

218.968

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

Testing

Monitoring and Recordkeeping for Control Devices

General Recordkeeping and Reporting (Repealed)

Compliance Date

Registration

Applicability of Subpart BB (Renumbered)

Emissions Limitation at Polystyrene Plants (Renumbered)

Compliance Date (Repealed)

Compliance Plan (Repealed)

Special Requirements for Compliance Plan (Repealed)

Emissions Testing (Renumbered)

SUBPART PP: MISCELLANEOUS FABRICATED PRODUCT

MANUFACTURING PROCESSES

Applicability

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Testing

Cementable and Dress or Performance Shoe Leather

SUBPART QQ: MISCELLANEOUS FORMULATION MANUFACTURING

PROCESSES

Applicability

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Testing

SUBPART RR: MISCELLANEOUS ORGANIC CHEMICAL

MANUFACTURING PROCESSES

Applicability

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Testing
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

SUBPART IT: OTHER EMISSION UNITS

Section

218.980

218.983

218.986

218.987

218.988

Section

218.990

218.991

Applicability

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Testing

SUBPART UU: RECORDKEEPING AND REPORTING

Exempt Emission Units

Subject Emission Units

218.APPENDIX A:

218.APPENDIX B:

218.APPENDIX C:

218.APPENDIX D:

218.APPENDIX E:

218.APPENDIX G:

218.APPENDIX H:

List ofChemicals Defining Synthetic Organic Chemical and

Polymer Manufacturing

YOM Measurement Techniques for Capture Efficiency (Repealed)

Reference Methods and Procedures

Coefficients for the Total Resource Effectiveness Index (TRE)

Equation

List ofAffected Marine Terminals

TRE Index Measurements for SOCMI Reactors and Distillation

Units

Baseline YOM Content Limitations for Subpart F, Section 218.212

Cross-Line Averaging

AUTHORITY: Implementing Section 10 and authorized by Sections 27, 28, and 28.5 ofthe

Environmental Protection Act [415 ILCS 5110,27, 28,and 28.5].

SOURCE: Adopted at R91-7 at 15 Ill. Reg. 12231, effective August 16, 1991; amended in R91-

24 at 16 Ill. Reg. 13564, effective August 24, 1992; amended in R91-28 and R91-30 at 16 Ill.

Reg. 13864, effective August 24, 1992; amended in R93-9 at 17 Ill. Reg. 16636, effective

September 27, 1993; amended in R93-14 at 18 Ill. Reg. at 1945, effective January 24, 1994;

amended in R94-12 at 18 Ill. Reg. 14973, effective September 21, 1994; amended in R94-15 at

18 Ill. Reg. 16392, effective October 25, 1994; amended in R94-16 at 18 Ill. Reg. 16950,

effective November 15, 1994; amended in R94-21, R94-31 and R94-32 at 19 Ill. Reg. 6848,

effective May 9, 1995; amended in R94-33 at 19 Ill. Reg. 7359, effective May 22, 1995;

amended in R96-13 at 20 Ill. Reg. 14428, effective October 17, 1996; amended in R97-24 at 21

Ill. Reg. 7708, effective June 9, 1997; amended in R97-31 at 22 Ill. Reg. 3556, effective

February 2, 1998; amended in R98-16 at 22 Ill. Reg. 14282, effective July 16, 1998; amended in

R02-20 at 27 Ill. Reg 7283, effective April 8, 2003; amended in R04-12/20 at 30 Ill. Reg. 9684,
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

effective May 15,2006; amended in R06-21 at 31 Ill. Reg. 7086, effective April 30, 2007;

amended in R08-8 at 32 Ill. Reg. , effective '

SUBPART T: PHARMACEUTICAL MANUFACTURING

Section 218.480 Applicability

a) The rules ofthis Subpart, except for Sections 218.483 through 218.485 ofthis

Part, apply to all emission units ofVOM, including but not limited to reactors,

distillation units, dryers, storage tanks for VOL, equipment for the transfer of

VOL, filters, crystallizers, washers, laboratory hoods, pharmaceutical coating

operations, mixing operations and centrifuges used in manufacturing, including

packaging, of pharmaceuticals, and emitting more than 6.8 kg/day (15 Ibs/day)

and more than 2,268 kg/year (2.5 tons/year) ofVOM. Ifsuch an emission unit

emits less than 2,268 kg/year (2.5 tons/year) ofVOM, the requirements ofthis

Subpart still apply to the emission unit ifVOM emissions from the emission unit

exceed 45.4 kg/day (100 lbs/day).

b) Notwithstanding subsection (a) ofthis Section, the air suspension coater/dryer,

fluid bed dryers, tunnel dryers, and Accelacotas located in Libertyville Township,

Lake County, Illinois shall be exempt from the rules ofthis Subpart, except for

Sections 218.483 through 218.485, if emissions ofVOM not vented to air

pollution control equipment do not exceed the following levels:

1) For the air suspension coater/dryer: 2,268 kg/year (2.5 tons/year);

2) Except as set forth in subsection 218.480(b)(4) ofthis Section. for Fef

each fluid bed dryer: 4,535 kg/year (5.0 tons/year);

3) Except as set forth in subsection 218.480(b)(4) oftrus Section. forFef

each tunnel dryer: 6,803 kg/year (7.5 tons/year); and

For fluid bed dryers #1, #2, and #3 and for tunnel dryers #1, #2, #3. and

#4, the combined total annual emissions from the dryers listed in this

subsection 218.480(b)(4) shall not exceed 18.779 kg/year (20.7 tons/year).

[BOARD NOTE: tunnel dryers are otherwise referred to as warm air

dryers]; and
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

4~) For each Accelacota: 6,803 kg/year (7.5 tons/year).

c) Sections 218.483 through 218.485 ofthis Part apply to a source having one or

more emission units that:

1) Are used to manufacture pharmaceuticals, and

2) Emit more than 6.8 kg/day (15Ibs/day) ofVOM and more than 2,268

kg/year (2.5 tons/year) ofVOM, or, ifless than 2,268 kg/year (2.5

tons/year), these Sections still apply if emissions from one or more sources

exceed 45.4 kg/day (100 lbs/day).

d) No owner or operator shall violate any condition in a permit when the condition

results in exclusion of an emission unit from this Subpart.

e) Any pharmaceutical manufacturing source that becomes subject to the provisions

ofthis Subpart at any time shall remain subject to the provisions ofthis Subpart at

all times.

f) Emissions subject to this Subpart shall be controlled at all times consistent with

the requirements set forth in this Subpart.

g) Any control device required pursuant to this Subpart shall be operated at all times

when the source it is controlling is operated.

h) Determinations of daily and annual emissions for purposes ofthis Section shall be

made using both data on the hourly emission rate (or the emissions per unit of

throughput) and appropriate daily and annual data from records of emission unit

operation (or material throughput or material consumption data). In the absence

ofrepresentative test data pursuant to Section 218.487 ofthis Part for the hourly

emission rate (or the emissions per unit ofthroughput) such items shall be

calculated using engineering calculations, including the methods described in

Appendix B of "Control ofVolatile Organic Emissions from Manufacturing of

Synthesized Pharmaceutical Products" (EPA-450/2-78-029), incorporated by

reference in Section 218.112 ofthis Part. (This subsection shall not affect the

Agency's or the USEPA's authority to require emission tests to be performed

pursuant to Section 218.487 ofthis Part.)

i) Equipment and operations emitting YOM at a source subject to subsection (a) or

(c) ofthis Section and used to produce pharmaceutical products or a
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF PROPOSED AMENDMENT

pharmaceutical-like product such as a hormone, enzyme, or antibiotic, shall be

deemed to be engaged in the manufacture of pharmaceuticals for the purposes of

this Subpart.

(Source: Amended at 32 Ill. Reg. :, effective. --')