IEPA ATTACHMENT NO. IS

ILLINOIS POLLUTION CONTROL BOARD

June 19,2008

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 )

218.480(b» )

Proposed Rule. Second 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 ofthe 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 ofthe rules for first notice under the Illinois Administrative

Procedure Act (APA), 5 ILCS 10011-1 et seq (2006). See, 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 posthearing comment in support ofthe 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 ofthe rule.

BACKGROUND

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.
2

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.

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:

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) ofthis Section, forFef

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

11 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

4.2.) 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 ofthe proposed amendment to 35 Ill. Adm. Code 218,480(b), Abbott's original filing

included a Statement ofReasons (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 [ElP], Doc. No.EPA-452/ROl-00l,

United States Environmental Protection Agency (USEPA), Office ofAir and

Radiation, Office ofAir 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.
3

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

hearing, and ordered publication ofthe 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 ofthe Department

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

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

To date, DCEO has not responded to the request.

The proposal was published at 31 Ill. Reg.1458l (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 oftwo ofits

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 YOM 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 YOM 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 ofthe

proposed rule (including the absence of any DCEO study). 1 The sole participants were counsel

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

Abbott presented the testimony oftwo witnesses in support ofits 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 i.e., the aerial photograph ofthe Abbott Facility (Exh. 1),

USEPA EIP document (Exh. 2), and a revised table of historical YOM 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 ofthe 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 ofUSEPS 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:

1 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.
4

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

("VOM") from its combined fluid bed dryers and tunnel dyers in lieu ofratebased limits provided in Section 2l8.480(b). The net effect ofthe proposal will

result in a reduction of24.5 tons per year ofVOM 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 ofUSEPA'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

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. Id. If an organic solvent is volatilized

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

for different products, and is calculated from the quantity ofVOM 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. Id. '

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 ofthe

same type can be used in combination or interchangeably. In the use oftunnel 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. Id.

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

warm air up from the bottom ofthe 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

offluid 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 ofwater for the

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

dryers and water-based products will continue. Id.

"Process trains" are designed to accommodate the manufacture ofbatches in large or

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

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

required between batches ofdifferent products, Abbott prefers to continue running batches ofthe

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

time. Id.
5

Abbott explains that, for practical purposes, Section 2l8.480(b) defines a l2-month total

YOM 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 YOM 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 ofproduct to

maintain the equipment-specific YOM 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" ofproducts to dryers involves operating factors. But, the YOM

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 ifthe

campaign would have used the original equipment. !d.

Abbott's Emissions

Subpart T requires YOM controls for tunnel dryers and fluid bed dryers ifthe actual

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

25. Ifuncontrolled, 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 offluid 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 ofvariations in demand in the pharmaceutical industry, as well as Abbott's

use ofwater-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 waterbased processes because ofUnited States Food and Drug Administration (FDA) concerns,

Abbott does expect to see an increased use ofwater 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. See

USEPA EIP document (Exh. 2). The general principles ofthe 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.
6

Based on the highest two-year emission period (1999-2000) during the preceding tenyear period, Abbott calculated baseline emissions of 22.9 tpl. 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 halfthe 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 YOM limit was consistent with EIP guidelines. Tr. at

49-54.

Economic and Budgetary Information

At hearing, Abbott was reminded that lCAR 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 tum will result in more efficient and cost

effective production ofpharmaceutical 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 ofAbbott's

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

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

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

reductions ofVOM 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 ofIllinois within the meaning of Section 27(b) ofthe Act. 415

ILCS 5/27(b) (2006).

ORDER

The Board directs the Clerk to submit the following rules to lCAR 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

PART 218

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

44-46
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

218.126

218.127

218.128

218.129

Section

218.141

218.142

218.143

218.144

Section

7

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

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
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

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

8

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 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 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
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

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

9

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

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
10

218.480

218.481

218.482

218.483

218.484

218.485

218.486

218.487

218.488

218.489

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

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

Bulk Gasoline Plants

Bulk Gasoline Terminals

Gasoline Dispensing Operations - Storage Tank Filling Operations

Gasoline Delivery Vessels

Gasoline Volatility Standards
218.586

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

218.666

218.667

218.668

218.670

218.672

11

Gasoline Dispensing Operations - Motor Vehic1e 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 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
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

218.788

218.789

218.790

218.791

218.792

218.875

218.877

218.879

218.881

218.883

218.886

Section

12

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

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
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

Section

218.980

218.983

218.986

218.987

218.988

Section

218.990

218.991

13

Applicability

Permit Conditions (Repealed)

Control Requrrements

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

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

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
14

218.212 Cross-Line Averaging

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

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 April8, 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 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 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 Ibs/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);
15

3) Except as set forth in subsection 218.480(b)C4) ofthis Section, for I<ef

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

11 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 218.480Cb)C4) shall not exceed 18,688 kg/year C20.6 tons/year).

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

dryers]; and

42.) 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.)
16

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 32-1- Ill. Reg. , effective )

IT IS SO ORDERED.

I, John T. Therriault, Assistant Clerk ofthe 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
IEPA ATTACHMENT NO.Jk..

JOINT COMMITTEE ONADMINISTRATIVE RULES

ILLINOIS GENERAL ASSEMBLY

CO-CHAIR:

SEN. MAGGIE CROnY

CO-CHAIR:

REP. BRENT HASSERT

EXECUTIVE DIRECTOR:

VICKI THOMAS

700 STRAITON BUILDING

SPRINGFIELD. ILLINOIS 62706

2171785-2254

SEN.J. BRADLEY 8URZYNSKI

SEN. JAMES CLAY80RNE, JR.

SEN. RANDALL HULTGREN

SEN. DAN RUTHERFORD

SEN. IRA SILVERSTEIN

REP. JOHN FRITCHEY

REP. LOU LANG

REP. DAVID R. LEITCH

REP. DAVID MILLER

REP. ROSEMARY MULLIGAN

TO: Tanner Girard, Chairman

Pollution Control

EIVED

'S OFFICE'

JUt 142008

1;;)STATE OF ILLINOIS • olIuturm Control Board

FROM:

DATE:

RE:

Vicki Thomas

Executive Director

7/10/08

Organic Material Emission Standards and Limitations for the Chicago Area (35

Ill. Adm. Code 218)

31 Ill. Reg. 14581 - 10/26/07

The Office of the Joint Committee on Administrative Rules has accepted the Second Notice for

the above-referenced rulemaking. The Second Notice period began on 7/10/08 and ends no later

than 8/23/08, unless extended pursuant to Section 5-40 ofthe lAPA.

This rulemaking is s.chedu1ed to be considered by JCAR at its 8/19/08 meeting, currently

scheduled for 10:30 a.m., Room 16-503, James R. Thompson Center, Chicago, lL. Staff will be

contacting you if they have questions concerning this rulemaking and will advise you of any

change in time or location ofthe Committee meeting.

Please contact us if you have any questions regarding the lCAR review procedure.

VT:DC:rm

cc: John Therriault

Nancy Miller

Adm. Code Div.

r

IEPA ATTACHMENT NO. -

I~

JOINT COMMITTEE ONADMINISTRATIVE RULES

ILLINOIS GENERAL ASSEMBLY

CO-CHAIR:

SEN. MAGGIE CROTTY

CO-CHAIR:

REP. BRENT HASSERT

EXECUTIVE DIRECTOR:

VICKI THOMAS

700 STRATTON BUILDING

SPRINGFIELD, ILLINOIS 62706

217/785-2254

August 19,2008

Tanner Girard, Chainnan

Pollution Control Board

James R. Thompson Center

100 W. Randolph, Suite 11-500

Chicago, lllinois 60601

Dear Chainnan Girard:

SEN. J. BRADLEY BURZYNSKI

SEN. JAMES CLAYBORNE, JR.

SEN. RANDALL HULTGREN

SEN. DAN RlJTHERFORD

SEN. IRA SILVERSTEIN

REP. JOHN FRITCHEY

REP. LOU LANG

REP. DAVID R. LEITCH

REP. DAVID MILLER

REP. ROSEMARY MULLIGAN

This is to notify you that JCAR considered the following proposed rulemakings at its 8/19/08

meeting:

Organic Material Emission Standards and Limitations for the Chicago Area (35 Ill. Adm.

Code 218) R.. i>% t

31 lll. Reg. 14581 - 10/26/07

Water Quality Standards (35 lll. Adm. Code 302)

31 Ill. Reg. 13624 - 10/5/07 ~~ 1 - <7

Pennits (35 lll. Adm. Code 309) /) )_ c

31 lll. Reg. 13642 -10/5/07 P' b I

State and NPDES Pennits (35 Ill. Adm. Code 405)

31 Ill. Reg. 13653 - 10/5/07 'K 7 - Co,

Mine Waste Effluent and Water Quality Standards (35 Ill. Reg. 406) ~f)':;-'e.,

31 Ill. Reg. 13660 - 10/5/07

Compliance and Effective Dates (Repealer) (35 lll. Adm. Code 407) f 0 I 9

31 lll. Reg. 13668 - 1015107

If your agency has agreed to any substantive modifications during its discussions with JCAR,

the~~e described in the "Agreements" attached to the certification. Based on these agreements,

as ~l as the other responses you have provided the Committee during the review of these

rulemakings, JCAR has detennined that No Objection will be issued. Enclosed you will find
fonnal certification ofthis action.

These rulemakings may now be adopted upon filing with the Office ofthe Secretary ofState.

Please note that the fact that the Committee has not objected to these rulemakings does not

necessarily constitute approval, expressed or implied, ofthe substance ofthe rulemakings.

Thank you for the cooperation your agency has shown during our review ofthese issues.

Sincerely,

Senator

~%~ Maggie Crotty

Co-Chainnan

SMC:RBH:DC:rm

cc: John Therriault

Nancy Miller

Marie Tipsord

Enc.

lepresentative Brent Hassert

Co-Chainnan
CO-CHAIR:

SEN. MAGGIE CROTTY

CQ-CHAIR:

REP. BRENT HASSERT

EXECUTIVE DIRECTOR:

VICKI THOMAS

JOINT COMMITTEE ONADMINISTRATIVERULES

ILLINOIS GENERAL ASSEMBLY

700 STRATTON BUILDING

SPRINGFIELD, ILLINOIS 62706

217nB5-2254

JOINT COMMITTEE ON ADMINISTRATIVE RULES

CERTIFICATION OF NO OBJECTION

TO PROPOSED RULEMAKING

SEN. J. BRADLEY BURZYNSKI

SEN. JAMES CLAYBORNE, JR.

SEN. RANDALL HULTGREN

SEN. DAN RUTHERFORD

SEN. IRA SILVERSTEIN

REP. JOHN FRITCHEY

REP. LOU LANG

REP. DAVID R. LEITCH

REP. DAVID MILLER

REP. ROSEMARY MULLIGAN

This is to certify that the Joint Committee on Administrative Rules, at its 8/19/08 meeting,

considered Organic Material Emission Standards and Limitations for the Chicago Area (35 Ill.

Adm. Code 218), proposed by the Pollution Control Board and published in the 10/26/07 issue of

the Illinois Register. After consideration, and based upon the agreements, if any, for

modification of the rulemaking made by the agency and attached to this document, the

Committee determined that no Objection will be issued to the above-mentioned rulemaking.

August 19,2008

Vicki Thomas

Executive Director

Attachments: Agreements
Agency:

Rulemaking:

Changes:

SECOND NOTICE CHANGES

Pollution Control Board

Organic Material Emission Standards and Limitations for the Chicago

Area (35 Ill. Adm. Code 218; 31 Ill. Reg. 14581)

1. In line 418, change "(20.6) tons/year" to "(20.6 tons/year)".

7/15/08
IEPA ATTACHMENT NO. IB

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 )

2l8.480(b)) )

Adopted Rule. Final Order.

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 ofthe 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 ofthe rules for first

notice under the Illinois Administrative Procedure Act (APA), 5 ILCS 10011-1 et seq (2006). See,

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 ofthe

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 ofno 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 ofthe rule.

BACKGROUND

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
2

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 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 ofthe 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:

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) ofthis Section, for Fef each tunnel

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

.1l 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

4~ 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 ofthe

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 ofAbbott Park and Vicinity,

Libertyville Township, Illinois (Exh. 1), a document entitled Improving Air Quality with Economic

Incentive Programs [EIP], Doc. No.EPA-452/R01-00l, United States Environmental Protection Agency

(USEPA), Office ofAir and
3

Radiation, Office ofAir Quality Planning and Standards (Jan. 2001) (Exh. 2), and a table entitled

"Historical YOM 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 ofthe 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 ofthe Department ofCommerce and Economic

Opportunity (DCEO) to request an economic impact study concerning this rulemaking as required by

Section 27 (b) ofthe Act. 415 ILCS 5/27(b) (2006). To date, DCEO has not responded to the request.

The proposal was published at 31 Ill. Reg.l4581 (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 oftwo ofits 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 YOM 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 YOM 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 ofthe proposed rule

(including the absence of any DCEO study). 1 The sole participants were counsel for, and employees of,

Abbott and IEPA; no members ofthe public attended the hearing.

Abbott presented the testimony oftwo witnesses in support ofits 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 i.e., the aerial photograph ofthe Abbott Facility (Exh. 1), USEPA ElP document (Exh. 2), and a

revised table ofhistorical YOM 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 ofthe IEPA Bureau ofAir. During the

course of hearing, Abbott and the IEPA advised that USEPA had requested Abbott to provide IEPA with

1 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.
4

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 ofUSEPS 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 ofrate-based limits provided

in Section 218,480(b). The net effect ofthe proposal will result in a reduction of24.5

tons per year ofVOM 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 ofno 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. Id. If

an organic solvent is volatilized from the dryer, it is emitted to the ambient air as YOM. The quantity of

YOM emissions varies for different products, and is calculated from the quantity ofVOM 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. Id.

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 ofthe same type can be

used in combination or interchangeably. In the use oftunnel 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. Id.

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

up from the bottom ofthe 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 offluid 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 ofwater for the massing fluid in future products.

Abbott expects that this preferential use offluid bed dryers and water-based products will continue. Id.
5

"Process trains" are designed to accommodate the manufacture ofbatches in large or small

scales. Beno at 4. The scale of a given batch plays an important role in determining which ofthe 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 ofthe same product consecutively in

the process train to minimize this cleaning and lost production time. Id.

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

YOM 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 YOM 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 ofproduct to maintain the equipment-specific

YOM 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 YOM 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 ifthe campaign would have used the original equipment. Id.

Abbott's Emissions

Subpart T requires YOM controls for tunnel dryers and fluid bed dryers ifthe 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 offluid 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 ofwater-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 ofUnited States Food

and Drug Administration (FDA) concerns, Abbott does expect to see an increased use ofwater 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. See USEPA EIP

document (Exh. 2). The general principles ofthe EIP are integrity, equity, and environmental benefit.
6

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 tpy2. 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

halfthe 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 YOM 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 tum 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 ofAbbott'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 ofits process equipment. At the same time,

adoption ofthe alternative compliance method suggested will result in net reductions ofVOM 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 ofIllinois within the

meaning of Section 27(b) ofthe Act. 415 ILCS 5/27(b) (2006).

ORDER

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

2Use ofthis method of emissions calculations was recommended by IEPA and USEPA. Tr. at 44-46.
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

218.126

218.127

218.128

218.129

Section

218.141

218.142

218.143

218.144

7

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 ofOrganic 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
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

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

8

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 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

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
218.409

218.410

218.411

9

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

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

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

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

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
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

218.489

Section

218.500

218.501

218.502

218.503

218.504

218.505

218.506

218.520

218.521

218.522

218.523

218.524

218.525

218.526

218.527

Section

218.541

Section

218.561

218.562

218.563

10

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

Recordkeeping for Air Pollution Control Equipment

SUBPART V: BATCH OPERATIONS AND AIR OXIDATION PROCESSES

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)

SUBPART W: AGRICULTURE

Pesticide Exception

SUBPART X: CONSTRUCTION

Architectural Coatings

Paving Operations

Cutback Asphalt
Section

218.581

218.582

218.583

218.584

218.585

218.586

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

11

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 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
218.660

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

218.788

218.789

218.790

218.791

218.792

12

Applicability

Control Requrrements

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

Testing

Monitoring and Recordkeeping for Control Devices

General Recordkeeping and Reporting (Repealed)

Compliance Date

Registration
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

Section

218.980

218.983

218.986

218.987

218.988

Section

218.990

218.991

13

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 FORMULAnON 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
218.APPENDIX A:

218.APPENDIX B:

218.APPENDIX C:

218.APPENDIX D:

218.APPENDIX E:

218.APPENDIX G:

218.APPENDIX H:

14

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 CrossLine Averaging

AUTHORITY: Implementing Section 10 and authorized by Sections 27,28,28.5 ofthe 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 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 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 (151bs/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 Ibs/day).

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

dryers, tunnel dryers, and Acce1acotas located in Libertyville Township, Lake County,

Illinois shall be exempt from the rules ofthis Subpart, except for Sections 218.483
15

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) ofthis Section, for Fei: each tunnel

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

11 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

4~ For each Acce1acota: 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 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,
16

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 VOM 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 32 Ill. Reg. , effective )

IT IS SO ORDERED.

Board Member Andrea S. Moore abstained.

Section 41(a) ofthe 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); see also 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

101.520; see also 35 Ill. Adm. Code 101.902, 102.700, 102.702.

I, John T. Therriault, Assistant Clerk ofthe 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
IEPA ATTACHMENT NO. I OJ

ReCEIVED

CLERK'S OFFICr:'

Sf? 0$ 200" l)tl?

STATE OF fLLfNo; .... Pollution Control eo~ro

OFFICE OF THE SECRETARY OF STATE

JESSE WHITE. Secretary of State

9/3/2008

POLLUTION CONTROL BOARD

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

JOHN THERRIAULT ASSISTANT CLERK

CHICAGO, IL 60601

Dear JOHN THERRIAULT ASSISTANT CLERK

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

Volume 32, Issue 37 of the Illinois Register, dated 9/12/2008.

ADOPTED RULES

Organic Material Emission Standards and Limitations for the Chicago Area

3511I. Adm. Code 218

Point Of Contact:Nancy Miller

Page 14874

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
1) Heading ofthe Part:

Chicago Area

ILLINOIS REGISTER

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

3) Section Numbers:

218.480

Adopted Action:

Amend

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

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

5) Effective Date ofAmendments: AUG 262008

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

7) Do these amendments contain incorporations by reference? No

8) The adopted amendments, on file in the Board's Chicago office at the James R.

Thompson Center, 100 W. Randolph, Suite 11-500 and are available for public

inspection.

9) Notice ofProposal Published in lllinois Register:

October 26,2007; 31 Ill. Reg. 14581

10) Has JCAR issued a Statement ofObjections to these amendments? No

11) Differences between proposal and final version:

The Board made changes to the text as it was published in the Illinois Register only to

reflect the text that the Board filed with the Secretary ofState's Index department for first

notice.

12) Have all the changes agreed upon by the agency and JCAR been made as indicated in the

agreements letter issued by JCAR? Yes

13) Will these amendments replace emergency amendments currently in effect? No

14) Are there any amendments pending on this Part? No

15) Summary and Purpose ofAmendments:

RECEIVED

AU~ 262008

sos-cooe 01\1.
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT

For a more detailed discussion ofthese amendments, see the Board's August 21, 2008

opinion and order in docket R08-8: Abbott Laboratories' Proposed Site Specific

Amendment to Applicability Section ofOrganic 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 Acce1acotas. The adopted amendment allows Abbott to "cap" and lower the

overall emissions allowable from its tunnel dryers numbered #1, #2, #3 and #4, and fluid

bed dryers numbered #1, #2 and #3, and to calculate the amount of exempted emissions

from the dryers based on the actual combined emissions from the dryers. The Illinois

Environmental Protection Agency and the United States Environmental Protection

Agency supported the rule. The Board found that the proposed amendment will reduce

the overall allowable emissions from these units while increasing Abbott's operational

flexibility, by allowing Abbott to make preferential use ofthe more efficient fluid bed

dryers.

16) Information and questions regarding these adopted amendments shall be directed to:

Kathleen Crowley

Illinois Pollution Control Board

100 W. Randolph 11-500

Chicago,IL 60601

312-814-6929

Copies ofthe Board's opinions and orders may be requested from the Clerk ofthe Board

at the address listed in #8 above or by calling 312/814-3620. Please refer to the Docket

number R08-08 in your request. The Board order is also available from the Board's Web

site (www.ipcb.state.il.us)

The full text ofthe Adopted 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 ADOPTED 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 ofOrganic 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 ADOPTED 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 ReliefValves

SUBPARTE: SOLVENTCLE~G

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 ADOPTED AMENDMENT

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

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 Mter 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

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED 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
218.487

218.488

218.489

Section

218.500

218.501

218.502

218.503

218.504

218.505

218.506

218.520

218.521

218.522

218.523

218.524

218.525

218.526

218.527

Section

218.541

Section

218.561

218.562

218.563

Section

218.581

218.582

218.583

218.584

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT

Testing

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 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)

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
218.585

218.586

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

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT

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 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

SUBPARTBB: POLYSTYRENE PLANTS

Applicability

Emissions Limitation at Polystyrene Plants

Emissions Testing

SUBPART CC: POLYESTER RESIN PRODUCT MANUFACTURING

PROCESS
Section

218.660

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

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT

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

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
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

218.928

218.929

Section

218.940

218.943

218.946

218.947

218.948

Section

218.960

218.963

218.966

218.967

ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT

Surface Preparation Materials

Work Practices

Testing

Monitoring and Recordkeeping for Control Devices

General Recordkeeping and Reporting (Repealed)

Compliance Date

Registration

Applicability ofSubpart 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
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT

218.968

Section

218.980

218.983

218.986

218.987

218.988

Section

218.990

218.991

Testing

SUBPART TT: OTHER EMISSION UNITS

Applicability

Pennit 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 Tenninals

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 27,28,28.5 ofthe

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 TIL 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 TIL Reg. 3556, effective
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT

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 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 lbslday)

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 (l00 lbslday).

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) ofthis Section, for Fef

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

11 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)C4) shall not exceed 18,688 kglyear (20.6 tons/year).

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

dryers1; and
ILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED 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 (15 lbs/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 ofemission 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 ADOPTED AMENDMENT

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

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

this Subpart.

(Source: Amended at 32 Ill. Reg. :, effective -')
CERTIFICATE OF AMENDED PART

The Pollution Control Board certifies that the attached hereto is a true and correct copy of:

Heading ofPart: Organic Material Emission Standards and Limitations for the Chicago

Area

Code Citation: 35 m. Adm. Code 218

Sections Involved: 218.480

Statutory Authority: 415 ILCS 5/28.6415 ILCS 5/13.6

which was duly adopted by this Agency on the 21st day ofAugust, 2008.

G. Tanner Girard

Acting Chairman