FIRST DRAFT 9/27/07 (KMC/njm)

THE PROPOSAL
MOTIONS
DISCUSSION
1. Lastly, the Board denies the motion for expedited consideration. Requests for expedited review are governed by Section 101.512 of the Board's rules, and must contain, inter alia, a complete statement of the 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 a minimum, 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).
  1. Section 218.480 Applicability

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;

SUBPART T: PHARMACEUTICAL

MANUFACTURING (35 ILL. ADM. CODE

(Rulemaking -Air)

Proposed Rule. First Notice.

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 of Environmental 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 of its request by,

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

Administrative Procedure Act (APA) (5 ILCS 100/1-1)(2006).

, 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 of the 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

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

make preferential use of the more efficient fluid bed dryers.

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

petition, as required by 35 Ill. Adm. Code Section 102.202(g). In support of this 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 of first notice. Abbott also

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

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

In support of this 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 if more information is needed that

it will expeditiously provide it.

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 of the proposal

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

the “published study or report” requirement of Section 102.210(c). 35 Ill. Adm. Code

35 Ill. Adm. Code 102.210(g). The Board requests that Abbott address

Section 102.210(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

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

review are governed by Section 101.512 of the Board's rules, and must contain,

complete statement of the facts and reasons for the request.

35 Ill. Adm. Code 101.512. In

acting on a motion for expedited review, the Board considers, at a minimum, 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.

35 Ill. Adm. Code 101.512(c).

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

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

Abbott’s assertions that actual emissions would be lowered if it 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 if the Board

were to accept that Abbott’s claims amount to “material prejudice”, the Board’s limited

resources in light of its 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 of this proposal without

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

text of the proposed 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

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

ORGANIC MATERIAL EMISSION STANDARDS AND

LIMITATIONS FOR THE CHICAGO AREA

SUBPART A: GENERAL PROVISIONS

Abbreviations and Conversion Factors

Test Methods and Procedures

Compliance Dates

Operation of Afterburners

Exemptions, Variations, and Alternative Means of Control or Compliance

Vapor Pressure of Volatile Organic Liquids

Vapor Pressure of Organic Material or Solvent

Vapor Pressure of Volatile Organic Material

Incorporations by Reference

Monitoring for Negligibly-Reactive Compounds

Compliance with Permit Conditions

SUBPART B: ORGANIC EMISSIONS FROM STORAGE AND LOADING

Applicability for VOL

Control Requirements for Storage Containers of VOL

Storage Containers of VPL

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

Separation Operations

Pumps and Compressors

Safety Relief Valves

SUBPART E: SOLVENT CLEANING

Solvent Cleaning in General

Open Top Vapor Degreasing

Conveyorized Degreasing

Compliance Schedule (Repealed)

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 of Organic Material

Compliance Schedule

Recordkeeping and Reporting

Cross-Line Averaging to Establish Compliance for Coating Lines

Recordkeeping and Reporting for Cross-Line Averaging Participating Coating

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 of Organic Material

Alternative Standard

Fuel Combustion Emission Units

Operations with Compliance Program

SUBPART H: PRINTING AND PUBLISHING

Flexographic and Rotogravure Printing

Compliance Schedule

Recordkeeping and Reporting

Lithographic Printing: Applicability

Provisions Applying to Heatset Web Offset Lithographic Printing Prior to March

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)

Control Requirements

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

Control of Reactors, Distillation Units, Crystallizers, Centrifuges and Vacuum

Control of Air Dryers, Production Equipment Exhaust Systems and Filters

Material Storage and Transfer

In-Process Tanks

Other Emission Units

Monitoring for Air Pollution Control Equipment

Recordkeeping for Air Pollution Control Equipment

SUBPART V: BATCH OPERATIONS AND AIR OXIDATION PROCESSES

Applicability for Batch Operations

Control Requirements for Batch Operations

Determination of Uncontrolled 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)

Determination of Applicability

Emission Limitations for Air Oxidation Processes

Testing and Monitoring

Compliance Date (Repealed)

SUBPART W: AGRICULTURE

Pesticide Exception

SUBPART X: CONSTRUCTION

Architectural Coatings

Paving Operations

Cutback Asphalt

SUBPART Y: GASOLINE DISTRIBUTION

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

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

Exemption for Waterbase Material and Heatset Offset Ink

Permit Conditions (Repealed)

Open Top Mills, Tanks, Vats or Vessels

Compliance Schedule

Recordkeeping and Reporting

SUBPART BB: POLYSTYRENE PLANTS

Emissions Limitation at Polystyrene Plants

Emissions Testing

SUBPART CC: POLYESTER RESIN PRODUCT MANUFACTURING

Control Requirements

Compliance Schedule

Recordkeeping and Reporting for Exempt Emission Units

Recordkeeping and Reporting for Subject Emission Units

SUBPART DD: AEROSOL CAN FILLING

Control Requirements

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

Control Requirements

Compliance Certification

Testing and Monitoring

Recordkeeping and Reporting

SUBPART HH: MOTOR VEHICLE REFINISHING

Emission Limitations

Alternative Control Requirements

Equipment Specifications

Surface Preparation Materials

Monitoring and Recordkeeping for Control Devices

General Recordkeeping and Reporting (Repealed)

Compliance Date

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

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Cementable and Dress or Performance Shoe Leather

SUBPART QQ: MISCELLANEOUS FORMULATION MANUFACTURING

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

SUBPART RR: MISCELLANEOUS ORGANIC CHEMICAL

MANUFACTURING PROCESSES

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

SUBPART TT: OTHER EMISSION UNITS

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

SUBPART UU: RECORDKEEPING AND REPORTING

Exempt Emission Units

Subject Emission Units

218.APPENDIX A:

List of Chemicals Defining Synthetic Organic Chemical and

Polymer Manufacturing

218.APPENDIX B:

VOM Measurement Techniques for Capture Efficiency (Repealed)

218.APPENDIX C:

Reference Methods and Procedures

218.APPENDIX D:

Coefficients for the Total Resource Effectiveness Index (TRE)

218.APPENDIX E:

List of Affected Marine Terminals

218.APPENDIX G:

TRE Index Measurements for SOCMI Reactors and Distillation

218.APPENDIX H:

Baseline VOM Content Limitations for Subpart F, Section 218.212

Cross-Line Averaging

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

Environmental Protection Act [415 ILCS 5/10 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

The rules of this Subpart, except for Sections 218.483 through 218.485 of this

Part, apply to all emission units of VOM, 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 lbs/day)

and more than 2,268 kg/year (2.5 tons/year) of VOM. If such an emission unit

emits less than 2,268 kg/year (2.5 tons/year) of VOM, the requirements of this

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

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

Notwithstanding subsection (a) of this 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 of this Subpart, except for

Sections 218.483 through 218.485, if emissions of VOM not vented to air

pollution control equipment do not exceed the following levels:

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

Except as set forth in subsection 218.480(b)(4) of this Section, for

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

Except as set forth in subsection 218.480(b)(4) of this Section, for For

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

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

Sections 218.483 through 218.485 of this Part apply to a source having one or

more emission units that:

Are used to manufacture pharmaceuticals, and

Emit more than 6.8 kg/day (15 lbs/day) of VOM and more than 2,268

kg/year (2.5 tons/year) of VOM, or, if less 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).

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

results in exclusion of an emission unit from this Subpart.

Any pharmaceutical manufacturing source that becomes subject to the provisions

of this Subpart at any time shall remain subject to the provisions of this Subpart at

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

the requirements set forth in this Subpart.

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

when the source it is controlling is operated.

Determinations of daily and annual emissions for purposes of this 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

of representative test data pursuant to Section 218.487 of this Part for the hourly

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

calculated using engineering calculations, including the methods described in

Appendix B of "Control of Volatile Organic Emissions from Manufacturing of

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

reference in Section 218.112 of this 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 of this Part.)

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

(c) of this 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 of pharmaceuticals for the purposes of

(Source: Amended at 31 Ill. Reg. __________, effective ___________)

IT IS SO ORDERED.

Member A. S. Moore abstained.

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

the Board adopted the above order on October 4, 2007, by a vote of 3-0.

___________________________________

John T. Therriault, Assistant Clerk

Illinois Pollution Control Board