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. SecondNotice. R08-8 (Rulemaking

- Air)

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

On September4,2007, Abbott Laboratories (Abbott) filed aproposal for site-specific rulemaking pursuantto 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. AtAbbott's request, on October4,2008, the Board ordered immediate publication ofthe rules for first notice underthe Illinois Administrative Procedure Act (APA), 5 ILCS 10011-1 

### etseq (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 Boardheld 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 outthe proposal's background, summarize the proposal, and discuss the evidence presented andpublic 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 subjectto 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 ofexempted emissions from the dryers based on the actual combined emissions from the dryers. Abbott believes that, ifadopted, the proposed amendment would reduce the overall allowable emissions from these units while increasing Abbott's operational flexibility, by allowing itto 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 shownby 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 ventedto airpollution control equipment do not exceed the following levels:
1) Forthe 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, forFef 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 inthis 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 eachAccelacota: 6,803 kg/year (7.5 tons/year).

PROCEDURAL HISTORY

As previously stated, Abbott filed this proposal on September4, 2007. As well as the text ofthe proposed amendment to 35 Ill. Adm. Code 218,480(b), Abbott's original filing included a StatementofReasons (S.R.) and three exhibits (Exh.): an Aerial Photograph of Abbott Park and Vicinity, Libertyville Township, Illinois (Exh. 1), a document entitled ImprovingAir 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 atthe Abbott ParkFacility." (Exh. 3). The proposal was accompanied by motions to waive the 200-signature requirement, and a request for expedited decision.3

On October4, 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 ofOctober 18, 2008, the Boardrequested the Director ofthe Department ofCommerce and Economic Opportunity (DCEO) to request an economic impact study concerning this rulemaking as requiredby Section 27 (b) ofthe Act. 415 ILCS 5/27(b) (2006). To date, DCEO has notresponded to the request.

The proposal was published at 31 Ill. Reg.1458l (Oct. 26,2007). JCAR filed its technical comment onthe first notice on October 18, 2007, and its Request for Economic and Budgetary Effects on October22,2008.

Pursuantto a January 31, 2008 hearing officer order setting a March 7,2008 hearing date, and asking questions to be addressed athearing, Abbottpre-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 bettertake into account data on its historical YOM emissions. The March 4, 2008 hearing officer order granted the motionto modify, but reserved ruling on a motion to revise Exhibit 3, the table ofhistorical YOM emissions to be presented at hearing. The order additionally specified questions the Boardrequested the participants to address at hearing.

The Boardheld 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 proposedrule (including the absence ofany DCEO study). 1 The sole participants were counsel for, and employees of, Abbott and IEPA; no members ofthe public attended the hearing.

Abbottpresented the testimony oftwo witnesses in support ofits proposal: Diane Beno, the plantmanager at the Facility's Building AP16, and Robert C. Wells Air Manager for Environmental Supportin 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 ofhistorical YOM emissions (Exh. 3). Three additional exhibits were entered: a chartentitled "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 ofhearing, Abbott and the IEPA advised thatUSEPA had requested Abbott to provide IEPA with additional data. The hearing officer accordingly setMay 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 Boardreceived 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 correctthe transcript, which is granted. Citations to the transcript (Tr.) in this opinion are to the transcript as corrected consistentwith the motion granted today.4

Abbottproposed a source-specific cap on emissions ofvolatile 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 peryear ofVOM emissions.

The Illinois EPA has determined that the proposal will not adversely affectthe air quality in Illinois. The Illinois EPA further consulted the United States Environmental Protection Agency ("USEPA") and concludedthat the proposal is consistentwiththe guidelines ofUSEPA's Economic Incentive Program. Accordingly, afterreviewing 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 atthe Facility, Abbottproduces intermediate and final pharmaceutical product formulation using batchproduction processes. Active and inactive ingredients are combined with a liquid in aprocess called "massing to form uniform granules. Wet granules are dried intunnel dryers or fluid bed dryers and then further processed into tablets

or capsules. Beno at 2. The massing fluid, which is typically eitherwater or ethanol, is evaporated from the solid material inthe drying step. Id. Ifan organic solvent is volatilized from the dryer, itis emitted to the ambient air as YOM. The quantity ofVOM emissions varies for differentproducts, and is calculated from the quantity ofVOM added to the mixture and loss factors defined for the dryers and specified in the CleanAir Act PermitProgram (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 canbe used in combination or interchangeably. In the use oftunnel dryers, materials to be dried are spread ontrays andplaced 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 thatblows
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. Abbotthas increased its use offluid bed dryers for recently developedproducts because they are more efficient and produce

amore uniformproductthan the tunnel dryers. Abbottanticipates 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 at4. The scale ofa given batchplays an importantrole in determining which ofthe dryers willbe most efficient. Also, giventhe amount ofcleaning (up to three days) requiredbetweenbatches ofdifferent products, Abbottprefers to continue running batches ofthe

same product consecutively inthe process train to minimize this cleaning and lostproduction 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 at4. To ensure compliance with each dryers' limit, for aparticularbatch, Abbott may needto utilize a dryer with low YOM emissions during the last 12 months instead ofusing the most efficientdryer from aproduction scale viewpoint. This

can result in inefficientuse ofa large-scale process train to dry a small batch ofproductto maintain the equipment-specific YOM limits. Beno at4-5.

Total annual emissions from a dryerresult from the quantity oforganic solvent removed from the differentproducts processed in a dryer over arolling 12-monthperiod. The assignment ofa "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, butresults inno environmental benefit, because the actual emissions will be the same as ifthe campaign would have used the original equipment. !d.

Abbott's Emissions
SubpartT requires YOM controls for tunnel dryers and fluid bed dryers ifthe actual emissions exceed 7.5 tons peryer (tpy) for a tunnel dryer of5 tpy for a fluid bed dryer. Tr. at 25. Ifuncontrolled, the four tunnel dryers andthree fluid bed dryers involved here have a potential to emit45 tpy. The seven dryers' actual emissions vary; inrecent 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 peryear ofoperation. Tr. at25-26.

Athearing, 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 overtime. Tr. at 35. The only organic solventAbbotthas used during the last 10 years is ethanol. Since 2002, Abbotthas been using beverage grade ethanol (which does not contain methanol as the denaturant.) While itis impractical to change ethanol-basedprocesses to waterbasedprocesses because ofUnited States Food and Drug Administration (FDA) concerns, Abbott does expectto see an increased use ofwater innew products. Tr. at 40. While fluid bed dryers are, by their mode ofoperation, more efficientthan tunnel dryers, Abbott does not expect to be able to phase outtunnel dryers entirely, as switching the technologies canhave an impact
on the drug product so as to raise FDA concerns.

USEPA Economic Incentive Program

As a result ofdiscussions between Abbott, IEPA, and USEPA, a compliance alternative

was developed called a Source Specific Emissions Cap (SSEC) underUSEPA'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 Abbottto combine its future emissions limits for all 7 dryers, and establish a limitbelow the historical actual emissions, ratherthan the previously allowable emissions oremissions allowable without control. Tr. at27.6

Based on the highesttwo-year emission period (1999-2000) during the preceding tenyearperiod, Abbott calculatedbaseline emissions of22.9 tpl. Reducing thatby tenpercentto guarantee a net environmental benefit, the new emission limt wouldbe 20.6 tpy for the seven dryers. This is less than halfthe current45 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 couldproperly considerAbbott's request
even though the state has not formally adopted anEIP policy, and has no currentplans to do so. Tr. at 49. He also confirmed thatIEPA and USEPA considerAbbott'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 limitwas consistent with EIP guidelines. Tr. at 49-54.

Economic and Budgetary Information

Athearing, Abbottwas reminded that lCAR hadrequested 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 inmore efficient and cost effective production ofpharmaceutical products. Moreover, the proposal will not impose any new requirements onAbbott orthe 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 Abbottby allowing it to use its businessjudgment in determining the most efficientuse ofits process equipment. At the same time, adoption ofthe alternative compliance method suggested will result innet 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 ofSection 27(b) ofthe Act. 415 ILCS 5/27(b) (2006).

ORDER

The Board directs the Clerkto submitthe 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 ofemissions calculations was recommended by IEPA andUSEPA. Tr. at 44-46Section 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 ConversionFactors Applicability Definitions TestMethods 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 PetroleumLiquid 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 ReliefValves

SUBPART E: SOLVENT CLEANING218.181 218.182 218.183 218.184 218.185 218.186

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

SolventCleaning in General Cold Cleaning Open Top Vapor Degreasing Conveyorized Degreasing Compliance Schedule (Repealed) TestMethods

SUBPART F: COATING OPERATIONS

Emission Limitations Daily-Weighted Average Limitations Solids Basis Calculation Alternative Emission Limitations Exemptions from Emission Limitations Exemption from General Rule onUse ofOrganic Material Compliance Schedule Recordkeeping and Reporting Cross-Line Averaging to Establish Compliance for Coating Lines Recordkeeping and Reporting for Cross-Line Averaging Participating Coating Lines Changing Compliance Methods Wood Furniture Coating Averaging Approach Wood Furniture Coating Add-On Control Use Wood Furniture Coating Work Practice Standards

SUBPART G: USE OF ORGANIC MATERIAL

Use ofOrganic Material Alternative Standard Fuel Combustion EmissionUnits 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 HeatsetWeb OffsetLithographic Printing Priorto March 15, 1996 Emission Limitations and Control Requirements for Lithographic Printing Lines On and AfterMarch 15, 1996 Compliance Schedule for Lithographic Printing On and AfterMarch 15, 1996 Testing for Lithographic Printing On and AfterMarch 15, 1996 Monitoring Requirements for Lithographic Printing Recordkeeping and Reporting for Lithographic PrintingSection 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: RUBBERAND 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 MANUFACTURING10

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 EquipmentExhaust Systems and Filters Material Storage and Transfer In-Process Tanks Leaks Other EmissionUnits 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 CutbackAsphalt

SUBPART Y: GASOLINE DISTRIBUTION Section 218.581 218.582 218.583 218.584 218.585 BulkGasoline Plants Bulk Gasoline Terminals Gasoline Dispensing Operations

- Storage TankFilling Operations Gasoline Delivery Vessels Gasoline Volatility Standards218.586

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

- MotorVehic1e 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 SolventDry Cleaners Operating Practices for Petroleum SolventDry Cleaners Program for Inspection and Repair ofLeaks Testing and Monitoring Applicability for Petroleum SolventDry 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 orVessels 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 ExemptEmission Units Recordkeeping and Reporting for SubjectEmission Units

SUBPART DD: AEROSOL CAN FILLINGSection 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 ExemptEmission Units Recordkeeping and Reporting for SubjectEmission 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 ofSubpartBB (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 PROCESSES218.920 218.923 218.926 218.927 218.928 218.929

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 orPerformance 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: OTHEREMISSION UNITS
Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing

SUBPARTUU: RECORDKEEPING AND REPORTING
ExemptEmission Units SubjectEmission 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 PolymerManufacturing 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 ContentLimitations for SubpartF, Section14

218.212 Cross-Line Averaging

AUTHORITY: Implementing Section 10 and authorizedby Sections 27, 28, 28.5 ofthe Environmental Protection Act [415 ILCS 5/10 and 28.5].

SOURCE: Adopted atR91-7 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 August24, 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 October25, 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 inR06-21 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 butnot 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 exemptfrom the rules ofthis Subpart, except for Sections 218.483 through 218.485, ifemissions ofVOM notvented to air pollution control equipment do not exceed the following levels:
1) Forthe 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, forFef 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 ifemissions 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 ofan emission unit from this Subpart.
e) Any pharmaceutical manufacturing source thatbecomes subjectto the provisions ofthis Subpart at any time shall remain subjectto the provisions ofthis Subpart at all times.
f) Emissions subjectto 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 ofdaily and annual emissions for purposes ofthis Section shall be made using both data on the hourly emission rate (orthe emissions perunit of throughput) and appropriate daily and annual data from records ofemission unit operation (ormaterial throughput ormaterial consumption data). In the absence ofrepresentative test data pursuantto Section 218.487 ofthis Part for the hourly emissionrate (orthe emissions perunit 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), incorporatedby reference in Section 218.112 ofthis Part. (This subsection shall not affect the Agency's orthe USEPA's authority to require emission tests to be performed pursuantto Section 218.487 ofthis Part.)16

i) Equipment and operations emitting YOM at a source subjectto subsection (a) or (c) ofthis Section and used to produce pharmaceutical products or a pharmaceutical-like product such as ahormone, enzyme, or antibiotic, shallbe deemed to be engaged inthe 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 adoptedthe above opinion and order on June 19, 2008, by a vote of3-0 with Member Moore abstaining.

John T. Therriault, Assistant Clerk Illinois Pollution Control BoardIEPA ATTACHMENT NO.

# Jk..

JOINTCOMMITTEE ON ADMINISTRATIVERULES 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 1 42008

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 ofthe 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 extendedpursuant 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. Staffwill 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 ifyou have any questions regarding the 

### lCAR review procedure.

VT:DC:rm
cc: John Therriault Nancy Miller Adm. Code Div.

# r**I~** IEPA ATTACHMENT NO.

- 

### JOINTCOMMITTEE ON ADMINISTRATIVERULES 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

TannerGirard, Chainnan Pollution Control Board James R. 

### Thompson Center 100 W. Randolph, Suite 11-500 Chicago, lllinois 60601

DearChainnan 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 ofthese rulemakings, JCAR has detennined that No Objection will be issued. Enclosed you will findfonnal certificationofthis action.

Theserulemakings maynowbe adopted upon filing with the Office ofthe SecretaryofState.

Please note that the fact that the Committee 

### has not objected to these rulemakings does not necessarily constitute approval, expressed orimplied, ofthe substance ofthe rulemakings.

Thankyou for the cooperation your agencyhas shown during ourreview ofthese issues.
Sincerely,

# ~%~ SenatorMaggie Crotty Co-Chainnan

SMC:RBH:DC:rm

cc: John Therriault NancyMiller Marie Tipsord Enc. 

### lepresentativeBrentHassert Co-ChainnanCO-CHAIR: SEN. MAGGIE CROTTY
CQ-CHAIR: REP. BRENT HASSERT
EXECUTIVE DIRECTOR: VICKI THOMAS 

### JOINTCOMMITTEE ON ADMINISTRATIVERULES ILLINOIS GENERALASSEMBLY

700 STRATTON BUILDING SPRINGFIELD, ILLINOIS 62706 217nB5-2254


### JOINT COMMITTEE ONADMINISTRATIVE 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 bythe Pollution Control Board andpublished 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 Objectionwill be issued to the above-mentionedrulemaking.

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)".

7/15/08IEPA ATTACHMENT NO. 

# I

# B

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 (byN.J. Melas):

On September4, 2007, Abbott Laboratories (Abbott) filed aproposal for site-specific rulemaking pursuantto 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 October4,2008, the Board ordered immediate publication ofthe rules for first notice under the Illinois Administrative Procedure Act (APA), 5 ILCS 10011-1 etseq (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 Boardheld 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 apost-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 athearing. 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 ofState. This opinion will set outthe proposal's background, summarize the proposal, and discuss the evidence presented andpublic 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 volatile2

organic materials (VOM) at 35 Ill. Adm. Code, SubpartT - Pharmaceutical Manufacturing (SubpartT 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.

Abbottproposed to amend these site-specific exemptions by "capping" and lowering the overall emissions allowable underthe exemptions from its tunnel dryers numbered #1, #2, #3 and #4, and fluid bed dryers numbered #1, #2 and #3, and calculating the amount ofexempted emissions from the dryers based on the actual combined emissions from the dryers. Abbottbelieves that, ifadopted, the proposed amendment would reduce the overall allowable emissions from these units while increasing Abbott's operational flexibility, by allowing itto make preferential use ofthe more efficient fluid bed dryers.

Abbott's proposal to amend 35 Ill. Adm. Code 218.480(b), as modifiedby Abbott's February 29, 2008 filing, is as follows (proposed amendments are shownby 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, ifemissions ofVOM not vented to airpollution control equipment do not exceed the following levels:
1) Forthe 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 Fefeach 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 Fefeach 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 September4,2007. 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.) andthree exhibits (Exh.): an Aerial Photograph ofAbbott Park and Vicinity, Libertyville Township, Illinois (Exh. 1), a document entitledImprovingAir Quality with Economic Incentive Programs [EIP], Doc. No.EPA-452/R01-00l, United States Environmental Protection Agency (USEPA), Office ofAir and3

Radiation, Office ofAir Quality Planning and Standards (Jan. 2001) (Exh. 2), and a table entitled "Historical YOM AirEmissions from Tunnel Dryers and Fluid Bed Dryers at the Abbott ParkFacility." (Exh.3). The proposal was accompanied by motions to waive the 200-signature requirement, and a request for expedited decision.

On October4, 2008, the Board waived the 200 signatures, accepted the proposal for hearing, and orderedpublication ofthe rules for first notice without comment on the merits. However, the Board denied Abbott's motion for expedited decision, citing resource andtime constraints. By letter of October 18,2008, the Boardrequested the Director ofthe Department ofCommerce and Economic Opportunity (DCEO) to request an economic impact study concerning this rulemaking as requiredby Section 27 (b) ofthe Act. 415 ILCS 5/27(b) (2006). To date, DCEO has notresponded to the request.

The proposal was published at 31 Ill. Reg.l4581 (Oct. 26,2007). JCAR filed its technical comment onthe first notice on October 18, 2007, and its Request for Economic and Budgetary Effects

on October 22, 2008.

Pursuantto a January 31, 2008 hearing officer order setting a March 7, 2008 hearing date, and asking questions to be addressed athearing, Abbottpre-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 bettertake into account data on its historical YOM emissions. The March 4, 2008 hearing officer order granted the motion to modify, butreservedruling on a motion to revise Exhibit 3, the table of historical YOM emissions to be presented at hearing. The order additionally specified questions the Boardrequested the participants to address at hearing.

The Boardheld 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 ofany DCEO study). 1 The sole participants were counsel for, and employees of, Abbott and IEPA; no members ofthe public attended the hearing.

Abbottpresented the testimony oftwo witnesses in support ofits proposal: Diane Beno, the plantmanager at the Facility's Building AP16, and Robert C. Wells Air Manager for Environmental Supportin 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 aerialphotograph ofthe AbbottFacility (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 ofhearing, 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 correctthe 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 setMay 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 Boardreceived timely posthearing comments from Abbott (PC 1) and IEPA (PC 2). In its comment, IEPA stated that

Abbottproposed a source-specific cap on emissions ofvolatile 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 areduction of24.5 tons peryear 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 thatthe proposal is consistent with the guidelines of USEPA's Economic Incentive Program. Accordingly, afterreviewing 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 JCARunderthe APA. The proposal incorporated changes requestedby Abbott and discussed athearing. JCARvoted 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, Abbottproduces intermediate and final pharmaceutical product formulation using batchproductionprocesses. Active and inactive ingredients are combined with a liquid in aprocess 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 at2. The massing fluid, which is typically eitherwater or ethanol, is evaporated from the solid material in the drying step. Id. If

an organic solventis volatilized from the dryer, it is emitted to the ambient air as YOM. The quantity of YOM emissions varies for differentproducts, and is calculated from the quantity ofVOM added to the mixture and loss factors defined for the dryers and specified in the Clean AirAct PermitProgram (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 canbe used in combination orinterchangeably. In the use oftunnel dryers, materials to be dried are spread on trays and placed in a warming chamber or "tunnel" that circulates warm airover and under the trays. Id.

A fluid bed dryer is a large vertical cylindrical shaped vessel with a diffuser thatblows 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. Abbotthas increased its use offluid bed dryers for recently developedproducts because they are more efficient andproduce a more uniformproductthan 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 ofa givenbatchplays an importantrole in determining which ofthe dryers will be most efficient. Also, given the amountofcleaning (up to three days) required betweenbatches ofdifferentproducts, Abbottprefers to continue running batches ofthe same product consecutively in the process train to minimize this cleaning and lostproduction time. Id.

Abbott explains that, for practical purposes, Section 218.480(b) defines a 12-monthtotal YOM limit on each individual dryer. Beno at 4. To ensure compliance with each dryer's limit, for a particularbatchAbbottmay need to utilize a dryer with low YOM emissions during the last 12 months, instead ofusing the most efficient dryer from a production scale viewpoint. This can result in inefficient

use ofa large-scale process train to dry a small batch ofproductto maintainthe equipment-specific YOM limits. Beno at4-5.

Total annual emissions from a dryerresult from the quantity oforganic solventremoved from the differentproducts processed in a dryer over arolling 12-monthperiod. The assignment ofa "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, butresults in no environmental benefit, because the actual emissions will be the same as ifthe campaign would have usedthe original equipment. Id.

Abbott's Emissions
SubpartT requires YOM controls for tunnel dryers and fluid bed dryers ifthe actual emissions exceed 7.5 tons peryear (tpy) for a tunnel dryer of5 tpy for a fluid bed dryer. Tr. at25. Ifuncontrolled, the four tunnel dryers and three fluid bed dryers involved here have apotential to emit45 tpy. The
seven dryers' actual emissions vary; in recentyears, 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 peryear ofoperation. 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 inthe pharmaceutical industry, as well as Abbott's use ofwater-based solvents where available. Tr. at 33. Abbott does not expect emissions to increase overtime. Tr. at 35. The only organic solvent Abbotthas used during the last 10 years is ethanol. Since 2002, Abbott has been using beverage grade ethanol (which does notcontainmethanol as the denaturant.) While itis impractical to change ethanol-basedprocesses to water-based processes because ofUnited States Food and Drug Administration (FDA) concerns, Abbott does expectto see an increased use ofwaterin new products. Tr. at40. While fluid bed dryers are, by their mode ofoperation, more efficientthan tunnel dryers, Abbott does not expectto be able to phase outtunnel 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 aresult ofdiscussions between Abbott, IEPA, andUSEPA, a compliance alternative was developed called a Source Specific Emissions Cap (SSEC) underUSEPA'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 limitbelow the historical actual emissions, ratherthan 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 calculatedbaseline emissions of22.9 tpy2. Reducing thatby 10% to guarantee anet environmental benefit, the new emission limt wouldbe 20.6 tpy for the seven dryers. This is less than halfthe current45 tpy effective limit for the dryers. Tr. at 27-28.

Athearing, the Agency answered questions from the Board concerning USEPA's EIP. The Agency's Mr. Mahajan clarified that the Board couldproperly considerAbbott's request even though the state has not formally adopted an EIP policy, and has no currentplans to do so. Tr. at 49. He also confirmed that IEPA andUSEPA considerAbbott's proposal as satisfying EIP principles. Mr. Mahajan confirmed thatthe SSEC elements are those described in the USEPS guidance, andthat the proposed combined YOM limit was consistent with EIP guidelines. Tr. at49-54.

Economic and Budgetary Information

Athearing, Abbott was reminded thatJCAR had requested anEconomic and Budgetary Effects analysis be submittedto it with any second notice rule. Abbottpresented testimony that the proposed rule applies only to its units. The proposedrule will allow for increased operational flexibility at Abbott's facility, which, in tum will result inmore efficient and cost effective production of pharmaceutical products. Moreover, the proposal will not impose any new requirements on Abbott orthe 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 Abbottby allowing itto use its businessjudgmentin determining the most efficientuse ofits process equipment. At the same time, adoption ofthe alternative compliance method suggested will result in netreductions ofVOM emissions from Abbott's facility. The Board accordingly finds thatthe adoptedrule is economically reasonable, technically feasible, and will not impose anegative economic impact on the State ofIllinois within the meaning ofSection 27(b) ofthe Act. 415 ILCS 5/27(b) (2006).

ORDER

The Board directs the Clerkto file the following adopted rules with the Secretary ofState, to become effective upon filing (amendments adopted in this rulemaking continue to be indicated in the order, butwill notbe so indicated in final filed rule text):

TITLE 35: ENVIRONMENTAL PROTECTION SUBTITLE B: AIR POLLUTION CHAPTERI: POLLUTION CONTROL BOARD

2Use ofthis method ofemissions calculations was recommendedby 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

SUBCHAPTERc: 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 ConversionFactors Applicability Definitions TestMethods 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 PetroleumLiquid 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 ReliefValvesSection 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

SolventCleaning in General Cold Cleaning Open Top Vapor Degreasing Conveyorized Degreasing Compliance Schedule (Repealed) TestMethods

SUBPART F: COATING OPERATIONS

Emission Limitations Daily-Weighted Average Limitations Solids Basis Calculation Alternative Emission Limitations Exemptions from Emission Limitations Exemption from General Rule onUse ofOrganic Material Compliance Schedule Recordkeeping and Reporting Cross-Line Averaging to Establish Compliance for Coating Lines Recordkeeping and Reporting for Cross-Line Averaging Participating Coating Lines Changing Compliance Methods Wood Furniture Coating Averaging Approach Wood Furniture Coating Add-On Control Use Wood Furniture Coating Work Practice Standards

SUBPART G: USE OF ORGANIC MATERIAL

Use ofOrganic Material Alternative Standard Fuel Combustion Emission Units Operations with Compliance Program

SUBPART H: PRINTING AND PUBLISHING
Flexographic and Rotogravure Printing Applicability Compliance Schedule Recordkeeping and Reporting Lithographic Printing: Applicability Provisions Applying to HeatsetWeb OffsetLithographic Printing Priorto March 15, 1996 Emission Limitations and Control Requirements for Lithographic Printing Lines On and AfterMarch 15, 1996 Compliance Schedule for Lithographic Printing On and After March 15, 1996218.409 218.410 218.411 9

Testing for Lithographic Printing On and AfterMarch 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

PetroleumRefinery 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: RUBBERAND MISCELLANEOUS PLASTIC PRODUCTS

Manufacture ofPneumatic Rubber Tires Green Tire Spraying Operations Alternative Emission Reduction Systems218.464 218.465 218.466

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, DistillationUnits, Crystallizers, Centrifuges and Vacuum Dryers Control ofAir Dryers, Production EquipmentExhaust 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 CutbackAsphaltSection 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 TankFilling Operations Gasoline Delivery Vessels Gasoline Volatility Standards Gasoline Dispensing Operations

- MotorVehicle 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 SolventDry Cleaners Operating Practices for Petroleum Solvent Dry Cleaners Program for Inspection and Repair ofLeaks Testing and Monitoring Applicability for Petroleum SolventDry 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 orVessels Grinding Mills Storage Tanks Leaks CleanUp Compliance Schedule Recordkeeping and Reporting

SUBPART BB: POLYSTYRENE PLANTS
Applicability Emissions Limitation at Polystyrene Plants Emissions Testing

SUBPART CC: POLYESTER RESIN PRODUCT MANUFACTURING PROCESS218.660 218.666 218.667 218.668 218.670 218.672

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 ExemptEmission Units Recordkeeping and Reporting for SubjectEmission Units

SUBPART DD: AEROSOL CAN FILLING
Applicability Control Requirements Testing Recordkeeping and Reporting for ExemptEmission 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 Registration218.875 218.877 218.879 218.881 218.883 218.886

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 ofSubpartBB (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 orPerformance 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: OTHEREMISSION UNITS
Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing

SUBPART UU: RECORDKEEPING AND REPORTING
ExemptEmissionUnits SubjectEmission Units218.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 MeasurementTechniques 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 DistillationUnits Baseline YOM ContentLimitations for SubpartF, Section 218.212 CrossLine Averaging

AUTHORITY: Implementing Section 10 and authorizedby Sections 27,28,28.5 ofthe Environmental Protection Act [415 ILCS 5/10 and 28.5].

SOURCE: Adopted atR91-7 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 September27, 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 at22 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) andmore than 2,268 kg/year (2.5 tons/year) ofVOM. Ifsuch an emissionunit 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 shallbe exempt from the rules ofthis Subpart, except for Sections 218.48315

through 218.485, ifemissions ofVOM notvented to airpollution control equipment do not exceed the following levels:
1) Forthe 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, forFef-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, forFei: eachtunnel 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 airdryers]; and**4~** ForeachAcce1acota: 6,803 kg/year (7.5 tons/year).
c) Sections 218.483 through 218.485 ofthis Part apply to a source having one ormore emission units that:
1) Are used to manufacture pharmaceuticals, and
2) Emitmore 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 ifemissions from one ormore sources exceed 45.4 kg/day (100 Ibs/day).
d) No owner or operator shall violate any condition in apermit when the conditionresults in exclusion ofan emission unit from this Subpart.
e) Any pharmaceutical manufacturing source thatbecomes subjectto the provisions ofthis Subpart at any time shall remain subjectto the provisions ofthis Subpart at all times.
f) Emissions subjectto this Subpart shall be controlled at all times consistentwith the requirements set forth inthis Subpart.
g) Any control device requiredpursuantto this Subpart shall be operated at all times when the source it is controlling is operated.
h) Determinations ofdaily and annual emissions for purposes ofthis Section shall be made using both data on the hourly emissionrate (orthe emissions perunit ofthroughput) and appropriate daily and annual data from records ofemission unit operation (ormaterial throughput ormaterial consumption data). In the absence ofrepresentative test data pursuantto Section 218.487 ofthis Part for the hourly emission rate (orthe emissions per unit ofthroughput) such items shall be calculatedusing engineering calculations,16

including the methods described inAppendix B of"Control ofVolatile Organic Emissions from Manufacturing ofSynthesized Pharmaceutical Products" (EPA-450/2-78- 029), incorporatedbyreference in Section 218.112 ofthis Part. (This subsection shall not affect the Agency's orthe USEPA's authority to require emission tests to be performed pursuantto Section 218.487 ofthis Part.)
i) Equipment and operations emitting VOM at a source subjectto subsection (a) or (c) ofthis Section and used to produce pharmaceutical products or a pharmaceutical-like product such as ahormone, enzyme, or antibiotic, shall be deemedto be engaged in the manufacture ofpharmaceuticals for the purposes of this Subpart.
(Source: Amended at 32 Ill. Reg. , effective )

IT IS SO ORDERED.

Board MemberAndrea S. Moore abstained.

Section41(a) ofthe Environmental Protection Actprovides 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 CourtRule 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 thatmotions for the Boardto reconsider ormodify 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 Clerkofthe 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 BoardIEPA ATTACHMENT NO. 

# IOJ

ReCEIVED

CLERK'S OFFICr:'



## Sf? 0$200" l)tl? STATE OF

### fLLfNo;

.... Pollution Control**eo~ro** 

# OFFICE OF THE SECRETARY OF STATE
JESSEWHITE. Secretary ofState

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 THERRIAULTASSISTANT CLERK Your rules Listed below met our codification standards and have been published in Volume 32, Issue 37 ofthe Illinois Register, dated 9/12/2008.

ADOPTED RULES Organic Material Emission Standards and Limitations forthe 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) SectionNumbers: 218.480 Adopted Action: Amend
4) StatutoryAuthority: Implementing Section 10 and authorized by Sections 27 and 28 of the Environmental ProtectionAct [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 containincorporations byreference? No
8) The adopted amendments, on file in the Board's Chicago office at the James R. Thompson Center, 100W. Randolph, Suite 11-500 and are available for public inspection.
9) Notice ofProposal Publishedinlllinois Register:

October 26,2007; 31 Ill. Reg. 14581
10) Has JCAR issued a Statement ofObjections to these amendments? No
11) Differences betweenproposal and final version: The Boardmade changes to the text as itwas publishedin the Illinois Register

### onlyto reflect the text that the Board filed with the Secretary ofState's Index department for first notice.
12) Have all the changes agreed upon bythe agency and JCARbeen made as indicatedinthe agreements letterissuedbyJCAR? Yes
13) Will these amendments replace emergency amendments currentlyin 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

Fora more detailed discussion ofthese amendments, see the Board's August 21, 2008 opinion and orderin docket R08-8: AbbottLaboratories' Proposed Site Specific Amendmentto Applicability Section ofOrganic Material Emission Standards and Limitations for the Chicago Area; SubpartT: 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, andAcce1acotas. The adopted amendment allows Abbott to "cap" and lowerthe 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 ofexempted 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 supportedtherule. The Board found that theproposed amendmentwill reduce the overall allowable emissions from these units while increasing Abbott's operational flexibility, by allowing Abbott to makepreferential use ofthe more efficient fluidbed dryers.
16) Information and questions regarding these adopted amendments shallbe directed to:

Kathleen Crowley Illinois PollutionControl Board 100 W. Randolph 11-500 Chicago,IL 60601 312-814-6929
Copies ofthe Board's opinions and orders maybe requested from the Clerkofthe Board at the address listed in#8 above orby calling 312/814-3620. Please referto the Docket numberR08-08 inyourrequest. The Board orderis also available from the Board's Web site (www.ipcb.state.il.us)

The full text ofthe Adopted Amendmentbegins on the nextpage: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: AIRPOLLUTION CHAPTERI: POLLUTION CONTROL BOARD SUBCHAPTER c: EMISSIONS STANDARDS AND LIMITATIONS FOR STATIONARY SOURCES

PART 218 ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS FORTHE CHICAGO AREA

SUBPART A: GENERALPROVISIONS

Introduction Savings Clause Abbreviations and Conversion Factors Applicability Definitions TestMethods andProcedures Compliance Dates Operation ofAfterburners Exemptions, Variations, and Alternative Means ofControl or Compliance Determinations VaporPressure ofVolatile Organic Liquids VaporPressure ofOrganic Material or Solvent VaporPressure ofVolatile Organic Material Incorporations byReference Monitoring for Negligibly-Reactive Compounds Compliancewith PermitConditions

SUBPART B: ORGANIC EMISSIONS FROM STORAGEAND LOADING OPERATIONS
Applicability for VOL Control Requirements for Storage Containers ofVOL Storage Containers ofVPL Loading Operations Petroleum Liquid Storage Tanks External Floating Roofs Compliance Dates218.126 218.127 218.128 218.129

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 andReporting for VOL Operations

SUBPART C: ORGANIC EMISSIONS FROM MISCELLANEOUS EQUIPMENT
Separation Operations Pumps and Compressors VaporBlowdown SafetyReliefValves

SUBPARTE:**SOLVENTCLE~G** Solvent Cleaning in General Cold Cleaning Open Top VaporDegreasing Conveyorized Degreasing Compliance Schedule (Repealed) TestMethods

SUBPART F: COATING OPERATIONS

Emission Limitations Daily-Weighted Average Limitations Solids Basis Calculation Alternative Emission Limitations Exemptions from Emission Limitations Exemption from General Rule onUse 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 StandardsSection 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 CONTROLBOARD

NOTICE OF ADOPTED AMENDMENT

SUBPART G: USE OF ORGANIC MATERIAL

Use ofOrganic Material Alternative Standard Fuel Combustion Emission Units Operations with Compliance Program

SUBPART H: PRINTING AND PUBLISHING
Flexographic andRotogravure Printing Applicability Compliance Schedule Recordkeeping and Reporting Lithographic Printing: Applicability Provisions Applying to Heatset Web Offset Lithographic Printing Priorto March 15, 1996 Emission Limitations and Control Requirements for Lithographic Printing Lines On and AfterMarch 15, 1996 Compliance Schedule for Lithographic Printing On and AfterMarch 15, 1996 Testing for Lithographic Printing On and

### MterMarch 15, 1996 MonitoringRequirements for Lithographic Printing Recordkeeping and Reporting for Lithographic Printing

SUBPART 

### Q: SYNTHETIC ORGANIC CHEMICAL AND POLYMER MANUFACTURING PLANT

General Requirements Inspection ProgramPlan for Leaks InspectionProgram for Leaks Repairing Leaks Recordkeeping for Leaks Report for Leaks AlternativeProgram for Leaks Open-Ended Valves Standards for Control Devices Compliance Date (Repealed) Applicability Control Requirements Performance and Testing Requirements Monitoring Requirements218.435 218.436

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

PetroleumRefinery Waste Gas Disposal Vacuum Producing Systems Wastewater (Oil/Water) Separator Process Unit Turnarounds Leaks: General Requirements Monitoring ProgramPlan for Leaks Monitoring Program for Leaks Recordkeeping for Leaks Reporting for Leaks Alternative Program for Leaks SealingDevice Requirements Compliance Schedule for Leaks Compliance Dates (Repealed)

SUBPART S: RUBBER AND MISCELLANEOUS PLASTIC PRODUCTS

Manufacture ofPneumatic RubberTires Green Tire Spraying Operations Alternative Emission Reduction Systems Emission Testing Compliance Dates (Repealed) Compliance Plan (Repealed)

SUBPART T: PHARMACEUTICAL MANUFACTURING
Applicability Control ofReactors, DistillationUnits, Crystallizers, Centrifuges andVacuum Dryers Control ofAirDryers, Production Equipment Exhaust Systems andFilters Material Storage and Transfer In-Process Tanks Leaks OtherEmission Units218.487 218.488 218.489

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 forAir Pollution Control Equipment Recordkeeping for AirPollution Control Equipment

SUBPART V: BATCH OPERATIONS AND AIR OXIDATION PROCESSES
Applicability for Batch Operations Control Requirements for Batch Operations DeterminationofUncontrolled Total AnnualMass Emissions andAverage Flow Rate Values for Batch Operations Performance and Testing Requirements for Batch Operations Monitoring Requirements forBatch Operations Reporting andRecordkeeping for Batch Operations Compliance Date Emission Limitations forAir OxidationProcesses Definitions (Repealed) Savings Clause Compliance DeterminationofApplicability Emission Limitations for Air Oxidation Processes Testing andMonitoring Compliance Date (Repealed)

SUBPARTW: AGRICULTURE

Pesticide Exception

SUBPART X: CONSTRUCTION

Architectural Coatings Paving Operations CutbackAsphalt

SUBPART Y: GASOLINE DISTRIBUTION

Bulk Gasoline Plants Bulk Gasoline Terminals Gasoline Dispensing Operations

- Storage Tank Filling Operations Gasoline DeliveryVessels218.585 218.586

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

- MotorVehicle 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 SolventDry Cleaners Operating Practices forPetroleum Solvent Dry Cleaners Program for Inspection and Repair ofLeaks Testing and Monitoring ApplicabilityforPetroleum SolventDry Cleaners Compliance Dates (Repealed) CompliancePlan (Repealed)

SUBPART AA: PAINT AND INKMANUFACTURING
Applicability Exemption forWaterbase Material and Heatset Offset

### Ink Permit Conditions (Repealed) Open Top Mills, Tanks, Vats orVessels Grinding Mills Storage Tanks Leaks Clean Up Compliance Schedule Recordkeeping andReporting

SUBPARTBB: POLYSTYRENE PLANTS
Applicability Emissions Limitation at Polystyrene Plants Emissions Testing

SUBPART CC: POLYESTERRESIN PRODUCT MANUFACTURING PROCESSSection 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 andReporting for Exempt Emission Units Recordkeeping andReporting for Subject Emission Units

SUBPART DD: AEROSOL CAN FILLING
Applicability Control Requirements Testing Recordkeeping and Reporting for ExemptEmissionUnits Recordkeeping andReporting for SubjectEmission Units

SUBPARTFF: BAKERY OVENS (REPEALED)
Applicability (Repealed) Control Requirements (Repealed) Testing (Repealed) Monitoring (Repealed) Recordkeeping andReporting (Repealed) ComplianceDate (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 Specifications218.786 218.787 218.788 218.789 218.790 218.791 218.792 218.875 218.877 218.879 218.881 218.883 218.886

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 PreparationMaterials Work Practices Testing Monitoring and Recordkeeping for Control Devices General Recordkeeping andReporting (Repealed) Compliance Date Registration Applicability ofSubpartBB (Renumbered) Emissions Limitation at Polystyrene Plants (Renumbered) Compliance Date (Repealed)

. CompliancePlan (Repealed) Special Requirements for Compliance Plan (Repealed) Emissions Testing (Renumbered)

SUBPART PP: MISCELLANEOUS FABRICATED PRODUCT MANUFACTURINGPROCESSES
Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing Cementable and Dress orPerformance 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 ScheduleILLINOIS 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: OTHEREMISSION UNITS
Applicability Pennit Conditions (Repealed) Control Requirements Compliance Schedule Testing

SUBPARTUU: RECORDKEEPING AND REPORTING
ExemptEmission Units SubjectEmissionUnits

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 PolymerManufacturing YOM Measurement Techniques for Capture Efficiency (Repealed) Reference Methods and Procedures Coefficients forthe Total Resource Effectiveness Index (TRE) Equation List ofAffected Marine Tenninals TRE IndexMeasurements for SOCMI Reactors andDistillation Units BaselineYOM Content Limitations for SubpartF, Section 218.212 Cross-Line Averaging

AUTHORITY: Implementing Section 10 and authorized by Sections 27,28,28.5 ofthe Environmental ProtectionAct [415 ILCS 5/10 and 28.5].

SOURCE: Adopted at R91-7 at 15 Ill. Reg. 12231, effective August 16, 1991; amended inR91- 24 at 16 Ill. Reg. 13564, effective August24, 1992; amended in R91-28 and R91-30 at 16 Ill. Reg. 13864, effective August 24, 1992; amended inR93-9 at 17 Ill. Reg. 16636, effective September27, 1993; amended in R93-14 at 18 

### TIL Reg. at 1945, effective January 24, 1994; amended inR94-12 at 18 Ill. Reg. 14973, effective September21, 1994; amended inR94-15 at 18 Ill. Reg. 16392, effective October25, 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 inR94-33 at 19 Ill. Reg. 7359, effective May 22, 1995; amended in R96-13 at20 Ill. Reg. 14428, effective October 17, 1996; amended inR97-24 at21 Ill. Reg. 7708, effective June 9, 1997; amended in R97-31 at 22 

### TIL Reg. 3556, effective

### ILLINOIS REGISTER

POLLUTION CONTROLBOARD

NOTICE OF ADOPTED AMENDMENT
February 2, 1998; amended inR98-16 at 22 Ill. Reg. 14282, effective July 16, 1998; amended in R02-20 at 27 Ill. Reg. 7283, effectiveApril 8, 2003; amended in R04-12/20 at 30 Ill. Reg. 9684, effective May 15,2006; amended inR06-21 at 31 Ill. Reg. 7086, effective April 30, 2007; amended inR08-8 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, applyto all emission units ofVOM, includingbutnot limited to reactors, distillationunits, dryers, storage tanks for VOL, equipment for the transfer of VOL, filters, crystallizers, washers, laboratoryhoods, pharmaceutical coating operations, mixing operations and centrifuges used inmanufacturing, including packaging, ofpharmaceuticals, and emitting more than 6.8 kg/day (15 lbslday) andmore 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 applyto the emission unitifVOM emissions from the emission unit exceed45.4 kg/day (l00 lbslday).
b) Notwithstanding subsection (a) ofthis Section, the air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located inLibertyville Township, Lake County, Illinois shall be exempt from therules ofthis Subpart, exceptfor Sections 218.483 through 218.485, ifemissions ofVOM not vented to air pollutioncontrol equipmentdo not exceed the following levels:
1) Forthe 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 

### eachtunnel 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 dryers

### 1; andILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT**4~)** ForeachAccelacota: 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) Emitmore 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 ifemissions from one ormore
sources exceed45.4 kg/day (100 lbs/day).
d) No owner or operator shall violate any condition in a permitwhen the condition results in exclusionofan emission unit from this Subpart.
e) Anypharmaceuticalmanufacturing source thatbecomes subjectto theprovisions ofthis Subpart at anytime shall remain subjectto theprovisions ofthis Subpart at all times.
f) Emissions subjectto this Subpart shall be controlled at all times consistentwith the requirements setforth inthis Subpart.
g) Any control device requiredpursuant to this Subpart shallbe operated at all times whenthe source itis controlling is operated.
h) Determinations ofdaily and annual emissions for purposes ofthis Section shallbe made using both data onthe hourly emissionrate (orthe emissions perunitof throughput) and appropriate daily and annual data from records ofemission unit operation (ormaterial throughputormaterial consumption data). In the absence ofrepresentative test datapursuantto Section 218.487 ofthis Partfor the hourly emissionrate (orthe emissions perunit ofthroughput) such items shall be calculatedusing engineering calculations, including the methods described in Appendix B of"Control ofVolatile Organic Emissions from Manufacturing of SynthesizedPharmaceutical Products" (EPA-450/2-78-029), incorporatedby reference in Section 218.112 ofthis Part. (This subsection shall not affect the Agency's orthe USEPA's authority to require emissiontests to beperformed pursuantto Section 218.487 ofthis Part.)
i) Equipment and operations emitting YOM at a source subjectto subsection (a) or (c) ofthis Section and used to producepharmaceuticalproducts or aILLINOIS REGISTER

POLLUTION CONTROL BOARD

NOTICE OF ADOPTED AMENDMENT
pharmaceutical-likeproduct 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

ThePollution Control Boardcertifies thatthe attached hereto is atrue and correct copy of:
Heading ofPart: Organic Material Emission Standards and Limitations forthe Chicago Area

Code Citation: 35 

## m. Adm. Code 218

Sections Involved: 218.480
StatutoryAuthority: 415 ILCS 5/28.6415 ILCS 5/13.6

whichwas duly adopted bythis Agency on the 21st day ofAugust, 2008.

G. Tanner Girard Acting Chairman