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

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

ILLINOIS POLLUTION CONTROL BOARD

August 21, 2008

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)

Adopted Rule. Final Order.

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) (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

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.

On June 19, 2008, the Board adopted a second-notice proposal for submission to the Joint

Committee on Administrative Rules (JCAR) under the APA. The proposal incorporated changes

requested by Abbott and discussed at hearing. JCAR voted a certificate of no objection at its August 19,

2008 meeting. As JCAR suggested no changes, the final rule the Board adopts is identical to the rule as

proposed at second notice.

By today’s action, the Board adopts a final rule, to become effective upon its filing by the Clerk

with the Secretary of State. 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

Abbott proposed 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 modified 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 dryers]; and

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 (Jan. 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 hearing.

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

., 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),

Ms. 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

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.

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:

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.

On June 19, 2008, the Board adopted a second-notice proposal for submission to JCAR under the

APA. The proposal incorporated changes requested by Abbott and discussed at hearing. JCAR voted a

certificate of no objection at its August 19, 2008 meeting.

UNCONTESTED EVIDENCE CONCERNING ABBOTT’S PROCESS AND EMISSIONS

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.

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 time.

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 dryer’s 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 year (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

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.

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 seven 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 10% 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 49-54.

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 adopted 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 file the following adopted rules with the Secretary of State, to

become effective upon filing (amendments adopted in this rulemaking continue to be indicated in the

order, but will not be so indicated in final filed rule text):

TITLE 35: ENVIRONMENTAL PROTECTION

SUBTITLE B: AIR POLLUTION

CHAPTER I: POLLUTION CONTROL BOARD

Use of this method of emissions calculations was recommended by IEPA and USEPA. Tr. at 44-46.

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 Determinations

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 OPERATIONS

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 EQUIPMENT

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 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 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 15,

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

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

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 Dryers

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 PROCESS

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

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

Cementable and Dress or Performance Shoe Leather

SUBPART QQ: MISCELLANEOUS FORMULATION MANUFACTURING PROCESSES

Permit Conditions (Repealed)

Control Requirements

Compliance Schedule

SUBPART RR: MISCELLANEOUS ORGANIC CHEMICAL MANUFACTURING

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

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) Equation

218.APPENDIX E:

List of Affected Marine Terminals

218.APPENDIX G:

TRE Index Measurements for SOCMI Reactors and Distillation Units

218.APPENDIX H:

Baseline VOM Content Limitations for Subpart F, Section 218.212 Cross-

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 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 dryers]; and

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

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 all times.

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 32 Ill. Reg. __________, effective ___________)

IT IS SO ORDERED.

Board Member Andrea S. Moore abstained.

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

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

order. 415 ILCS 5/41(a) (2006);

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

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

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

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

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

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

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

the Board adopted the above opinion and order on August 21, 2008, by a vote of. 3-0.

___________________________________

John T. Therriault, Assistant Clerk

Illinois Pollution Control Board