FIRST DRAFT 9/27/07 (NJM/kmc)

BACKGROUND
PROCEDURAL HISTORY
Abbott’s Emissions
BOARD CONCLUSION
1. Section 218.480 Applicability

ILLINOIS POLLUTION CONTROL BOARD

IN THE MATTER OF:

ABBOTT LABORATORIES’ PROPOSED

SITE SPECIFIC AMENDMENT TO

APPLICABILITY SECTION OF ORGANIC

MATERIAL EMISSION STANDARDS AND

LIMITATIONS FOR THE CHICAGO AREA;

SUBPART T: PHARMACEUTICAL

MANUFACTURING (35 ILL. ADM. CODE

(Rulemaking - Air)

Proposed Rule. Second 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 the Environmental Protection Act (Act), [add sp]415 ILCS

5/28 (2006), to allow it “additional operational flexibility” with regard to emissions from certain

tunnel dryers and fluid bed dryers at its pharmaceutical manufacturing facility located in

Libertyville Township, Lake County. At Abbott’s request, on October 4, 2008, the Board

ordered immediate publication of the rules for first notice under the Illinois Administrative

Procedure Act (APA), 5 ILCS 100/1-1

, respectively, 35 Ill. Adm. Code

Sections 102.202(g) and 101.512.

The proposal was published at 31 Ill. Reg. 14581 (Oct. 26, 2007). The Board held a

hearing on the proposal in Libertyville, Lake County on March 7, 2008. The sole participants

were Abbott and the Illinois Environmental Protection Agency (IEPA); IEPA filed a post-

hearing comment in support of the requested relief.

By today’s action, the Board adopts this second-notice order, and directs that the

proposed rule be submitted to the Joint Committee on Administrative Rules (JCAR) for its

review under the APA. This opinion will set out the proposal’s background, summarize the

proposal, and discuss the evidence presented and public comments made concerning the

economic reasonableness and technical feasibility of the rule.

Abbott owns a pharmaceutical manufacturing facility located in Libertyville Township,

Lake County, Illinois (the Facility). Abbott’s operations are subject to the emissions standards

for volatile organic materials (VOM) at 35 Ill. Adm. Code, Subpart T – Pharmaceutical

Manufacturing (Subpart T rules). As currently written, 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’s proposal to amend 35 Ill. Adm. Code 218.480(b), as modifed by Abbott’s

February 29, 2008 filing, is as follows (proposed amendments are shown by underlining new

language and striking through deleted language:

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 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 18,688 kg/year (20.6 tons/year).

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

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

PROCEDURAL HISTORY

As previously stated, Abbott filed this proposal on September 4, 2007. As well as the

text of the proposed amendment to 35 Ill. Adm. Code 218.480(b), Abbott's original filing

included a Statement of Reasons (S.R.) and three exhibits (Exh.): an Aerial Photograph of

Abbott Park and Vicinity, Libertyville Township, Illinois (Exh. 1), a document entitled

Improving Air Quality with Economic Incentive Programs

[EIP], Doc. No.EPA-452/R01-001,

United States Environmental Protection Agency (USEPA), Office of Air and

Radiation, Office of Air Quality Planning and Standards (January 2001) (Exh. 2) and a table

entitled "Historical VOM Air Emissions from Tunnel Dryers and Fluid Bed Dryers at the Abbott

Park Facility." (Exh. 3). The proposal was accompanied by motions to waive the 200-signature

requirement, and a request for expedited decision.

On October 4, 2008, the Board waived the 200 signatures, accepted the proposal for

hearing, and ordered publication of the rules for first notice without comment on the merits.

However, the Board denied Abbott’s motion for expedited decision, citing resource and time

constraints. By letter of October 18, 2008, the Board requested the Director of the Department

of Commerce and Economic Opportunity (DCEO) to request an economic impact study

concerning this rulemaking as required by Section 27 (b) of the Act. 415 ILCS 5/27(b) (2006).

To date, DCEO has not responded to the request.

The proposal was published at 31 Ill. Reg.14581 (Oct. 26, 2007). JCAR filed its

technical comment on the first notice on October 18, 2007, and its Request for Economic and

Budgetary Effects on October 22, 2008.

Pursuant to a January 31, 2008 hearing officer order setting a March 7, 2008 hearing

date, and asking questions to be addressed at hearing, Abbott pre-filed testimony of two of its

employees: Diane Beno and Robert C. Wells. On February 29, 2008, Abbott filed a motion to

modify its original proposal to better take into account data on its historical VOM emissions.

The March 4, 2008 hearing officer order granted the motion to modify, but reserved ruling on a

motion to revise Exhibit 3, the table of historical VOM emissions to be presented at hearing.

The order additionally specified questions the Board requested the participants to address at

The Board held a hearing on the proposal in Libertyville, Lake County on March 7, 2008

to receive testimony and comment concerning the merits and the economic impact of the

proposed rule (including the absence of any DCEO study).

The sole participants were counsel

for, and employees of, Abbott and IEPA; no members of the public attended the hearing.

Abbott presented the testimony of two witnesses in support of its proposal: Diane Beno,

the plant manager at the Facility’s Building AP16, and Robert C. Wells Air Manager for

Environmental Support in Abbott's Global Environmental Health & Safety Department. The

three previously identified exhibits were entered at hearing, and the hearing officer granted the

requested leave to file a revised exhibit

., the aerial photograph of the Abbott Facility (Exh. 1),

USEPA EIP document (Exh. 2), and a revised table of historical VOM emissions (Exh. 3).

Three additional exhibits were entered: a chart entitled "Granulation Process—Fluid Bed

Drying" and "Granulation Process—Tunnel Drying" (Exh. 4), Mr. Well’s pre-filed testimony

(Exh. 5) and the questions contained in the March 4, 2008 hearing officer order (Exh. 6).

The IEPA presented one witness, solely to answer questions posed by the Board:

Yoginder Mahajan, an Engineer with the Air Quality Planning Section of the IEPA Bureau of

Air. During the course of hearing, Abbott and the IEPA advised that USEPA had requested

Abbott to provide IEPA with additional data. The hearing officer accordingly set May 1, 2008

as the filing date for the participants’ closing comments to the Board, to facilitate preparation

and consideration of USEPS data requests. On May 1, 2008, the Board received timely post

hearing comments from Abbott (PC 1) and IEPA (PC 2). In its comment, IEPA stated that:

On April 7, 2008, Abbott filed an unopposed motion to correct the transcript, which is granted.

Citations to the transcript (Tr.) in this opinion are to the transcript as corrected consistent with

the motion granted today.

Abbott proposed a source-specific cap on emissions of volatile organic material

(“VOM”) from its combined fluid bed dryers and tunnel dyers in lieu of rate-

based limits provided in Section 218.480(b). The net effect of the proposal will

result in a reduction of 24.5 tons per year of VOM emissions.

The Illinois EPA has determined that the proposal will not adversely affect the air

quality in Illinois. The Illinois EPA further consulted the United States

Environmental Protection Agency (“USEPA”) and concluded that the proposal is

consistent with the guidelines of USEPA’s Economic Incentive Program.

Accordingly, after reviewing Abbott’s petition, the Illinois EPA supports the

requested site-specific relief. PC 2 at 1.

UNCONTESTED EVIDENCE CONCERNING ABBOTT’S PROCESS AND

Abbotts’ Process

In Building AP16 at the Facility, Abbott produces intermediate and final

pharmaceutical product formulation using batch production processes. Active and inactive

ingredients are combined with a liquid in a process called “massing to form uniform granules.

Wet granules are dried in tunnel dryers or fluid bed dryers and then further processed into tablets

or capsules. Beno at 2. The massing fluid, which is typically either water or ethanol, is

evaporated from the solid material in the drying step.

If an organic solvent is volatilized

from the dryer, it is emitted to the ambient air as VOM. The quantity of VOM emissions varies

for different products, and is calculated from the quantity of VOM added to the mixture and loss

factors defined for the dryers and specified in the Clean Air Act Permit Program (CAAPP)

Permit for the Facility.

Abbott's proposed site-specific amendment covers four tunnel dryers and three fluid bed

dryers. Beno at 3. The technologies are not interchangeable, although individual dryers of the

same type can be used in combination or interchangeably. In the use of tunnel dryers, materials

to be dried are spread on trays and placed in a warming chamber or "tunnel" that circulates warm

air over and under the trays.

A fluid bed dryer is a large vertical cylindrical shaped vessel with a diffuser that blows

warm air up from the bottom of the vessel. Beno at 3. The wet intermediate granules are loaded

into the dryer and flow upward, suspended in the warm air stream. Abbott has increased its use

of fluid bed dryers for recently developed products because they are more efficient and produce

a more uniform product than the tunnel dryers. Abbott anticipates increased use of water for the

massing fluid in future products. Abbott expects that this preferential use of fluid bed

dryers and water-based products will continue.

“Process trains” are designed to accommodate the manufacture of batches in large or

small scales. Beno at 4. The scale of a given batch plays an important role in determining

which of the dryers will be most efficient. Also, given the amount of cleaning (up to three days)

required between batches of different products, Abbott prefers to continue running batches of the

same product consecutively in the process train to minimize this cleaning and lost production

Abbott explains that, for practical purposes, Section 218.480(b) defines a 12-month total

VOM limit on each individual dryer. Beno at 4. To ensure compliance with each dryers’ limit,

for a particular batch, Abbott may need to utilize a dryer with low VOM emissions during the

last 12 months instead of using the most efficient dryer from a production scale viewpoint. This

can result in inefficient use of a large-scale process train to dry a small batch of product to

maintain the equipment-specific VOM limits. Beno at 4-5.

Total annual emissions from a dryer result from the quantity of organic solvent

removed from the different products processed in a dryer over a rolling 12-month period.

The assignment of a “campaign” of products to dryers involves operating factors. But, the VOM

emission threshold acts as an overriding factor. Beno at 5. This increases the operational cost,

but results in no environmental benefit, because the actual emissions will be the same as if the

campaign would have used the original equipment.

Abbott’s Emissions

Subpart T requires VOM controls for tunnel dryers and fluid bed dryers if the actual

emissions exceed 7.5 tons per yer (tpy) for a tunnel dryer of 5 tpy for a fluid bed dryer. Tr. at

25. If uncontrolled, the four tunnel dryers and three fluid bed dryers involved here have a

potential to emit 45 tpy. The seven dryers’ actual emissions vary; in recent years, tunnel dryer

emissions have varied from 0.6 tpy to 5.6 tpy, while those of fluid bed dryers have ranged from

0.1 tpy to 3.9 tpy per year of operation. Tr. at 25-26.

At hearing, in response to a Board queries, Abbott verified that the economics presented

in the R96-10 rulemaking had not changed. Tr. at 31-32. Similarly, since then there have been

no fundamental changes in emission control technology. Abbott’s lower emissions since 2000

have been the result of variations in demand in the pharmaceutical industry, as well as Abbott’s

use of water-based solvents where available. Tr. at 33. Abbott does not expect emissions to

increase over time. Tr. at 35. The only organic solvent Abbott has used during the last 10 years

is ethanol. Since 2002, Abbott has been using beverage grade ethanol (which does not contain

methanol as the denaturant.) While it is impractical to change ethanol-based processes to water-

based processes because of United States Food and Drug Administration (FDA) concerns,

Abbott does expect to see an increased use of water in new products. Tr. at 40. While fluid bed

dryers are, by their mode of operation, more efficient than tunnel dryers, Abbott does not expect

to be able to phase out tunnel dryers entirely, as switching the technologies can have an impact

on the drug product so as to raise FDA concerns.

USEPA Economic Incentive Program

As a result of discussions between Abbott, IEPA, and USEPA, a compliance alternative

was developed called a Source Specific Emissions Cap (SSEC) under USEPA’s EIP.

USEPA EIP document (Exh. 2). The general principles of the EIP are integrity, equity, and

environmental benefit. Tr. at 28-30. The SSEC would allow Abbott to combine its future

emissions limits for all 7 dryers, and establish a limit below the historical actual emissions,

rather than the previously allowable emissions or emissions allowable without control. Tr. at 27.

Based on the highest two-year emission period (1999-2000) during the preceding ten-

year period, Abbott calculated baseline emissions of 22.9 tpy

. Reducing that by ten percent to

guarantee a net environmental benefit, the new emission limt would be 20.6 tpy for the seven

dryers. This is less than half the current 45 tpy effective limit for the dryers. Tr. at 27-28.

At hearing, the Agency answered questions from the Board concerning USEPA’s EIP.

The Agency’s Mr. Mahajan clarified that the Board could properly consider Abbott’s request

even though the state has not formally adopted an EIP policy, and has no current plans to do so.

Tr. at 49. He also confirmed that IEPA and USEPA consider Abbott’s proposal as satisfying EIP

principles. Mr. Mahajan confirmed that the SSEC elements are those described in the USEPS

guidance, and that the proposed combined VOM limit was consistent with EIP guidelines. Tr. at

Economic and Budgetary Information

At hearing, Abbott was reminded that JCAR had requested an Economic and Budgetary

Effects analysis be submitted to it with any second notice rule. Abbott presented testimony that

the proposed rule applies only to its units. The proposed rule will allow for increased

operational flexibility at Abbott's facility, which, in turn will result in more efficient and cost

effective production of pharmaceutical products. Moreover, the proposal will not impose

any new requirements on Abbott or the Agency. Tr. at 9-10.

BOARD CONCLUSION

Based on the undisputed facts in this record, the Board finds that adoption of Abbott’s

proposed rule will result in definite, if unquantifiable, economic savings to Abbott by allowing it

to use its business judgment in determining the most efficient use of its process equipment. At

the same time, adoption of the alternative compliance method suggested will result in net

reductions of VOM emissions from Abbott’s facility. The Board accordingly finds that the

proposed rule is economically reasonable, technically feasible, and will not impose a negative

economic impact on the State of Illinois within the meaning of Section 27(b) of the Act. 415

ILCS 5/27(b) (2006).

The Board directs the Clerk to submit the following rules to JCAR for second-notice

review under the APA:

TITLE 35: ENVIRONMENTAL PROTECTION

SUBTITLE B: AIR POLLUTION

CHAPTER I: POLLUTION CONTROL BOARD

SUBCHAPTER c: EMISSIONS STANDARDS AND

LIMITATIONS FOR STATIONARY SOURCES

Use of this method of emissions calculations was recommended by IEPA and USEPA. Tr. at

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 32 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 18,688 kg/year (20.6 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 321 Ill. Reg. __________, effective ___________)

IT IS SO ORDERED.

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

the Board adopted the above opinion and order on June 19, 2008, by a vote of 3-0 with Member

Moore abstaining.

___________________________________

John T. Therriault, Assistant Clerk

Illinois Pollution Control Board