Electronic Filing, R'eceived,. Clerk"s.Office, September 4, 200lePAATTACHMENTNO. 

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BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: 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)). ) ) ) ) ) ) ) ) ) ) ) R08-

__ (Rulemaking

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NOTICE OF FILING TO: Mr. John T. Therriault Assistant Clerk ofthe Board Illinois Pollution Control Board 100 WestRandolph Street Suite 11-500 Chicago, Illinois 60601 (VIA ELECTRONIC MAIL) (SEE PERSONS ONATTACHED SERVICE LIST) PLEASE TAKE NOTICE that I have today filed with the Office ofthe Clerk of the Illinois Pollution Control Board an ENTRY OF APPEARANCE OF KATHERINE D. HODGE; ENTRY OF APPEARANCE OF GALE W. NEWTON; MOTION TO WAIVE REQUIREMENT TO SUBMIT 200 SIGNATURES; MOTION FOR EXPEDITED REVIEW; ABBOTT LABORATORIES' PROPOSAL OF AMENDMENTS; and STATEMENT OF REASONS, copies ofwhich are herewith served upon you. Respectfully submitted, ABBOTT LABORATORIES, Dated: September4, 2007 By: 

### lsi Katherine D. Hodge One ofIts Attorneys Katherine D. Hodge Gale W. Newton HODGE DWYERZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003/Fil/NOF

- site-specific rulemaking 218.480 TillS FILING SUBMITTED ON RECYCLED PAPER•. ,••**~"~._,.~** •. , ,. !,! ,'''''' """"**(/~** ,;, lIectronic Filing, Received, Clerk"s Office, September 4, 2007 

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CERTIFICATE OF SERVICE I, Katherine D. Hodge, the undersigned, certify that I have served the attached ENTRY OF APPEARANCE OF KATHERINE D. HODGE; ENTRY OF APPEARANCE OF GALE W. NEWTON; MOTION TO WAIVE REQUIREMENT TO SUBMIT 200 SIGNATURES; MOTION FOREXPEDITED REVIEW; ABBOTT LABORATORIES' PROPOSAL OF AMENDMENTS; and STATEMENT OF REASONS upon: Mr. John T. Therriault Assistant Clerk ofthe Board Illinois Pollution Control Board 100 West Randolph Street Suite 11-500 Chicago, Illinois 60601 via electronic mail on September4,2007; and upon: Division ofLegal Counsel Illinois Environmental Protection Agency 1021 North Grand Avenue East Post Office Box 19276 Springfield, Illinois 62794-9276 Office ofLegal Services Illinois Department ofNatural Resources One Natural Resources Way Springfield, Illinois 62702 by depositing said documents in the United States Mail in Springfield, Illinois, postage prepaid,

on September4,2007.



### lsI Katherine D. Hodge Katherine D. Hodge

ABOT:003/FiIlCOS

- Part218Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: ) ) PROPOSED SITE-SPECIFIC ) AMENDMENT TO APPLICABILITY ) SECTION OF ORGANIC ) MATERIAL EMISSION STANDARDS ) AND LIMITATIONS FOR THE ) CHICAGO AREA; SUBPARTT: ) PHARMACEUTICAL ) MANUFACTURING ) (35 ILL. ADM. CODE 218.480(b)) ) R08- (Rulemaking

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ENTRY OF APPEARANCE OF KATHERINE D. HODGE NOW COMES Katherine D. Hodge, ofthe law firm HODGE DWYERZEMAN, and hereby enters her appearance in this matter onbehalfofAbbottLaboratories. Respectfully submitted, By: /s/ Katherine D. Hodge Katherine D. Hodge Dated: September4, 2007 Katherine D. Hodge HODGE DWYERZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900

ABOT:003/FiI/EOA

- KDH 218Electronic Filing, Received, Clerk's Office, September 4, 2007 

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BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: ) ) 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)) ) R08- (Rulemaking

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ENTRY OF APPEARANCE OF GALE W. NEWTON NOW COMES Gale W. Newton, ofthe law firm HODGE DWYERZEMAN, and hereby enters his appearance in this matter onbehalfofAbbott Laboratories. Respectfully submitted,

By: /s/ Gale W. Newton Gale W. Newton Dated: September4, 2007 Gale W. Newton HODGE DWYERZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003/Fil/EOA

- GWN 218Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: ) ) 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)) ) R08- (Rulemaking

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### MOTION TO WAIVE REQUIREMENT TO SUBMIT 200 SIGNATURES NOW COMES ABBOTT LABORATORIES ("Abbott"), by and through its attorneys, HODGE DWYERZEMAN andrequests the Illinois Pollution Control Board ("Board") to waive the requirement, under 35 Ill. Admin. Code § 102.202(g), to submit 200 signatures with its Proposed Amendments to 35 Ill. Admin. Code Part 218 ("Part 218") stating as follows: 1. Abbott owns a pharmaceutical manufacturing facility inLibertyville Township, Lake County, Illinois for which it seeks site-specific amendments to regulations involving the applicability ofan exemptionfor certain dryers. 2. The Boardhas waived signature requirements for site-specific rulemaking petitions in the past, including recently In the matterofPetition ofCentral Illinois Light Company for a Site Specific Air Rule 35 III Adm Code 214141, R02-21; In the Matter of Petition ofthe City ofEffingham, Blue Beacon International Inc. and Truckomat Corporation for a Site Specific Water Pollution Regulation: 35 Ill. Admin. Code 304.105, R03-11; and In The Matter of: Proposed Site Specific Regulation Applicable to Ameren Energy generating Company, Elgin, Illinois Amending 35 IL. Adm. Code 901, R04-11.Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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3. Abbott is apublicly held company that employs thousands ofpeople nationwide and thatmanufactures pharmaceuticals that are usedby millions ofcustomers in the State ofIllinois and worldwide. Granting this motion is in the public interest of , those customers and others servedby Abbott. WHEREFORE, ABBOTT LABORATORIES, through its attorneys, respectfully requests the Illinois Pollution Control Boardto waive the requirementto submit200 signatures in support ofits Proposed Amendments to 35 Ill. Admin. Code Part 218. Respectfully submitted, ABBOTT LABORATORIES, By: /s/ Katherine D. Hodge One ofits Attorneys Dated: September4, 2007 Katherine D. Hodge Gale W. Newton HODGE DWYERZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900

ABOT:003/Fil/Motion to Waive Signatures

2Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATIER OF: ) ) PROPOSED SITE-SPECIFIC ) AMENDMENT TO APPLICABILITY ) SECTION OF ORGANIC ) MATERIAL EMISSION STANDARDS ) AND LIMITATIONS FORTHE ) CHICAGO AREA; SUBPART T: ) PHARMACEUTICAL ) MANUFACTURING ) (35 ILL. ADM. CODE 218.480(b)) ) R08- (Rulemaking

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MOTION FOREXPEDITED REVIEW NOW COMES ABBOTT LABORATORIES ("Abbott"), by and through its attorneys, HODGE DWYERZEMAN, and hereby requests the Illinois Pollution Control Board ("Board") to expedite review ofAbbott's Proposal ofAmendments to 35 Ill. Admin. Code Part 218.480(b). In support ofthis Motion, Abbott states as follows: 1. As set forth in the Proposal ofAmendments to 35 Ill. Admin. Code Part 218.480(b) ("Part 218.480(b)"), Abbott seeks to amend Part 218.480(b). Simultaneously with this Motion, Abbott is filing a StatementofReasons that describes the purpose and effectthatthe proposed changes will have on the administration ofPart218.480(b) requirements. 2. Part218.480(b), contains the site-specific applicability requirements for certain regulations regarding organic material emission standards and limitations for pharmaceutical manufacturing atAbbott's Libertyville Township, Lake County, Illinois facility.Electronic Filing, Received,Clerk"s Office, September 4, 2007 

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3. The rule, as it stands, requires Abbottto utilizeits equipment and

resources in a mannerthat is inefficientfor the production ofcertain ofits pharmaceutical products. 4. Continued operation in the inefficientmanner described above causes material prejudice to Abbott. 5. The proposed amendments are primarily intended to increase efficiency for Abbott's use ofcertain fluidizedbed andtunnel dryers while providing for lower allowable emissions from these dryers as a group. 6. The Illinois Environmental ProtectionAgency has been contacted andhas

no disagreementwith the proposed amendments. 7. The proposed rulemaking may be sentto first notice without a decision being reached onthe merits ofthe proposal by the Board. See, for example: In The Matter Of: Revisions to Water Quality Standards for Total Dissolved Solids inthe Lower Des Plaines River ExxonMobil Oil Corporation 2006 Ill. ENV LEXIS 167 (Ill. ENV 2006); In The Matter Of: Proposed Site Specific Regulation Applicable to Ameren Energy Generating Company, Elgin 2003 Ill. ENV LEXIS 667 (Ill. ENV 2003); and In The Matter Of: Petition OfW.R. Grace & Company.,. Connecticut, andthe Illinois EPA For Site-Specific Air Regulation, 1997 Ill. ENV LEXIS 717 (Ill. ENV 1997). 8. Therefore, Abbottrequests thatthe Boardproceed to FirstNotice under the Illinois Administrative Procedure Act, 5 ILCS 100/1-1, 

### etseq., withoutreaching a decision onthe merits, by accepting the regulatory language proposedby Abbottin this rulemaking proposal only forpurposes ofFirstNotice.

2Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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9. Abbott also requests thatthe requisite hearing be scheduled as soon as possible in accordance with Section 28(a) ofthe Illinois Environmental Protection Act, 415 ILCS 5/28(a). 10. Abbottbelieves thatthe informationnecessary for the Boardto proceed to FirstNotice inthis rulemaking and schedule apublic hearing is contained inthe Statement ofReasons. Ifmore information is needed, Abbottwill cooperate fully to expeditiously provide the same to the Board and its hearing officer. 11. As required by 35 Ill. Admin. Code 

### § 101.512, this Motion is accompanied by an affirmation attesting that the facts citedherein are true. WHEREFORE, for the above and foregoing reasons, ABBOTT LABORATORIES hereby respectfully requests the Illinois Pollution Control Boardto expedite review in this matter. Respectfully submitted, ABBOTT LABORATORIES By: 

### lsIKatherine D. Hodge One ofIts Attorneys Date: September4, 2007 Katherine D. Hodge Gale W. Newton HODGE DWYERZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900



### 3Electronic Filing, Received, Clerk's Office, September 4, 2007 

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AFFIDAVIT

STATE OF ILLINOIS

### COUNTYOF~ ) ) SS. 

### ) Diane Beno, being first dilly sworn on oath, affirms that, based upon appropriate inquiry, the facts setforth in the Motion forExpedited Review above are true and correct.

Diane Beno, AP

### 16 PlantManager Abbott Laboratories 100 Abbott ParkRoad AbbottPark, Illinois 847/937-1321 Subscribed and swornto before me this?day

### Of~1l6t, 2007.R08- (Rulemaking

- Air) Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: ) ) PROPOSED SITE-SPECIFIC ) AMENDMENT TO APPLICABILITY ) SECTION OF ORGANIC ) MATERIAL EMISSION STANDARDS ) AND LIMITATIONS FOR THE ) CHICAGO AREA; SUBPARTT: ) PHARMACEUTICAL ) MANUFACTURING ) (35 ILL. ADM. CODE 218.480(b)) ) ABBOTT LABORATORIES' PROPOSAL OF AMENDMENTS ABBOTT LABORATORIES ("Abbott"), by and through its attorneys, HODGE DWYER ZEMAN, pursuantto 35 Ill. Admin. Code § 102.202, moves the Illinois Pollution Control Board to accept for hearing Abbott's proposal for amendment of35 Ill. Admin. Code Part 218, Subpart T, Section 218.480(b). This regulatory proposal includes: 1) the Proposed Amendments; 2) the Statement ofReasons; 3) Appearances for the attorneys representing Abbott; 4) a Motion to Waive Requirementto Submit 200 Signatures; and, 5) a Motion for Expedited Review. Respectfully submitted, ABBOTT LABORATORIES, Dated: September4, 2007

Katherine D. Hodge Gale W. Newton HODGE DWYERZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003/Fil/Proposal ofAmendment

- 218 v2 By: /s/ Katherine D. Hodge One ofIts AttorneysElectronic Filing, Received, Clerk"s Office, September 4, 2007 

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PROPOSED AMENDMENTS 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 FOR THE CmCAGO AREA



### SUBPART T: PHARMACEUTICAL MANUFACTURING Section 

### 218.480 Applicability a) The rules ofthis Subpart, except for Sections 218.483 through 218.485 of this Part, apply to all emission units ofVOM, including butnot 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 (15Ibs/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 emissionunitifVOM emissions from the emission unit exceed 45.4 kg/day (100 lbs/day). b) Notwithstanding subsection (a) ofthis Section, the air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located in Libertyville Township, Lake County, Illinois shall be exempt from the rules ofthis Subpart, except for Sections 218.483 through 218.485, if emissions ofYOM 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) below, for W:w-each fluid bed dryer: 4,535 kg/year (5.0 tons/year); 3) Except as set forth in Subsection 218.480(b)(4) below. IorF-efeach tunnel dryer: 6,803 kg/year (7.5 tons/year); 

### fffiEl 4) For fluid bed dryers #1, #2 and #3 and f()r tunnel dryers #1, #2, #3

. and #4. the combined total annual emissions from the dryers listedElectronic Filing, Received,Clerk"s Office, September 4, 2007 

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in this Subsection 218.480(b)(4) shall not exceed: 18,779 kg/year (20.7 tons/year) [NOI'E: tu.nnel dryers are otherwise refcncd to as warm air dryers]: and**4~)** 

### For eachAccelacota: 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) Emit more than 6.8 kg/day (15Ibs/day) ofVOM andmore 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 lbs/day). d) No owner or operator shall violate any condition in apermit whenthe condition results in exclusion ofan emissionunit 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 shallbe controlled at all times consistent with the requirements set forth in this Subpart. g) Any control device required pursuantto this Subpart shall be operated at all times whenthe source itis controlling is operated. h) Determinations ofdaily and annual emissions for purposes ofthis Section shall be made using both data onthe hourly emission rate (orthe emissions perunit ofthroughput) and appropriate daily and annual data from records ofemission unit operation (ormaterial throughput or material consumption data). In the absence ofrepresentative test data pursuantto Section 218.487 ofthis Part for the hourly emissionrate (or the 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), incorporated by 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 performedpursuantto Section218.487 ofthis Part.) i) Equipment and operations emitting YOM at a source subject to subsection (a) or (c) ofthis Section andused to produce pharmaceutical products or a pharmaceutical-like product such as ahormone, enzyme, or antibiotic,Electronic Filing, Received, Clerk's Office, September 4, 2007 

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shallbe deemed to be engaged inthe manufacture ofpharmaceuticals for the purposes ofthis Subpart. (Source: Amended at Ill. Reg. -' effective..-pi\""ifaa:)r"**9~,-il~9~9Zl~~.** .J)Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: ) ) 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». ) R08- (Rulemaking

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### STATEMENT OF 

### REASONS Abbott Laboratories, an Illinois corporation, ("Abbott") hereby submits this Statement ofReasons to the Illinois Pollution Control Board ("Board") pursuantto Sections 27 and 28 ofthe Illinois Environmental Protection Act ("Act") (415 ILCS 5/27 and 28),35 Ill. Admin. Code § 102.210 and 35 Ill. Admin. Code § 102.202(b), in support ofthe attached proposed site-specific amendmentto 35 Ill. Admin. Code 

### § 218.480. Abbott owns apharmaceutical manufacturing facility located in Libertyville Township, Lake County, Illinois ("the Facility"). Abbottproduces numerous pharmaceutical products atthe Facility, and these operations are subjectto 35 Ill. Admin. Code, SubpartT - Pharmaceutical Manufacturing ("Subpart T"). As currently written, SubpartT, Section 218.480(b) ("Section 218.480(b)") contains certain exemptions that

are only applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located at the Facility. Abbott is proposing to amend these sitespecific exemptions by 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 listed aboveElectronic Filing, Received, Clerk"s Office, September 4, 2007 

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based onthe actual combined emissions from the dryers. Ifadopted, the proposed amendment wouldreduce the overall allowable emissions from these units while increasing Abbott's operational flexibility withregard to these units. I. SITE DESCRIPTION AND AREA AFFECTED Abbott is located at 100 AbbottPark Road inunincorporated Lake County. Abbott is a worldwide health care corporation with its headquarters located atthis site. Abbott conducts manufacturing andpackaging ofsolid dosage form pharmaceuticals (tablets, capsules, and granules) and liquid dosage form pharmaceuticals, preparation and filling ofbulk solutions for diagnostic kitreagents, final packaging and distribution of diagnostic kits, and research and development activities from bench-scale through small pilotplantprocesses. Abbott also operates manufacturing support services that include boilers, chillers, emergency generators, and other support services. The units affectedby the proposed amendment are locatednearthe center of Abbott's 567-acre facility. See aerial photograph attached as Exhibit 1. The site includes developedparcels with numerous buildings thathouse the on-site activities, plus contiguous parcels ofagricultural and vacant land. The area surrounding the site includes

a mixture ofresidential, commercial, and industrial land use. II. STATEMENT OF FACTS AND PURPOSE AND EFFECT OF PROPOSAL A. Facts 

### 1. Process The operations associated with this proposed amendment, contained in Building AP16, produce intermediate and final pharmaceuticalproduct formulations, including

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products utilized in the anti-infective, cardiovascular, vitamin and mineral supplement, epileptic, arthritic, allergic, andhuman immunodeficiency areas. The general process flow involves: receipt ofraw materials; weighing ofingredients; granulation of ingredients; compressing granulatedproductinto tablets; coating tablets orparticles; printing symbols onto finished products; and packaging finished products for distribution. The process includes drying certain products in tunnel dryers or fluid bed dryers. 

### 2. Hazardous Air Pollutants The processes associated with this proposed amendment do not involve the emissions ofany Hazardous AirPollutants. 

### 3. Original Section 218.480(b) Rulemaking The economic infeasibility ofinstalling controls onthe tunnel dryers and/or the fluid bed dryers was discussed during the original rulemaking regarding Section 218.480(b). Section 218.480(b) was promulgated after, and is essentially identical to, 35 Ill. Admin. Code § 215.480(b) ("Section 215.480(b)"). During the rulemaking process thatresulted in the promulgation ofSection 215.480(b), bothAbbott and the Illinois Environmental Protection Agency (the "Illinois EPA") provided technical documentation and testimony to the effect that certain emission sources, including tunnel dryers and fluid bed dryers, wouldbe economically infeasible to control at the levels required for certain other emission sources at the Facility. See Amendments to 35 Ill. Adm. Code 211 & 215 Organic Material Emission Standards and Limitations for Synthesized Pharmaceutical Manufacturing Plants, IPCB, R86-10. Therefore, the exemption promulgated in Section 215.480(b), and carried into Section 218.480(b), was included in

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the regulations. As currently written, the tunnel dryers and fluid bed dryers are exempt from the otherrequirements ofSubpartT (except for Sections 218.483 through 218.485 ofSubpartT, which covermaterial storage andtransfer, in-process tanks, and leaks, respectively) so long as the emissions ofVOM notvented to air"pollution control equipment do not exceed4,535 kg peryear (5.0 tons peryear) for each fluid bed dryer and 6,803 kg peryear (7.5 tons peryear) for each tunnel dryer. The Facility currently operates four tunnel dryers and four fluid bed dryers 1. The dryers are designated as tunnel dryers2 numbered #1, #2, #3 and#4 and fluid bed dryers numbered #1, #2, #3 and #4. One ofthe fluid bed dryers, designatedin the Facility's CAAPP permit as fluid bed dryer#4, is used inresearch and development operations and is not involved in the manufacturing processes. The proposed amendmentwould not affect this dryer and the discussion offluid bed dryers in this Statement ofReasons does
not include fluidbed dryer#4 unless a specific reference is made to that dryer. The CAAPP permitnames and emission unit designations for the seven affected dryers are presented in Table 1. TABLEt Seven Affected Dryers as Described in CAAPP Permit CAAPP Permit Dryer Name CAAPP Permit Dryer Emission Unit Number Warm Air Dryer 1 D-0964 WarmAirDryer2 D-0965 WarmAirDryer 3 D-0966 Warm AirDryer4 D-0967

1 In 1988, during the initial rulemaking, Abbott operated eighttunnel dryers andtwo fluidbed dryers. 2 The rule andthe CAAPP permituse differentnomenclature for the tunnel dryers. In the current version oftherule andthe proposed version ofthe rule, the term "Tunnel Dryers" is used. In the CAAPPpermit, the same dryers are referred to as "WarmAir Dryers." 4Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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CAAPP Permit DryerName CAAPP PermitDryer Emission Unit Number G-0917 Aeromatic Model No. T-8 2400 Fluid Bed Dryer (FBD #1) Aeromatic Model No. T-8 2400 Fluid Bed G-0955 Dryer (FBD #2) Aeromatic Model No. MP-8 Fluid Bed LC933770 Dryer (FBD #3)

With respectto the seven affected dryers, the total YOM emissions currently allowedunder the SubpartT exemption are 30 tons peryear from the tunnel dryers and 15 tons peryear from the fluid bed dryers, or a combined total of45 tons ofVOM emissions peryear from all seven dryers. 

### 4. Proposal Abbottproposes a source-specific cap for the fluid bed dryers and tunnel dryers under the United States Environmental Protection Agency's ("USEPA") Economic Incentive Program ("ElP"). Pursuantto the EIP guidance, a source-specific emission cap EIP substitutes a mass-based emissions cap for arate-based limit. See Improving Air Quality with Economic Incentive Programs, USEPA, January 2001, Pg. 97. Attached as Exhibit 2. Source-specific emission cap EIPs are intended to limit total emissions while providing compliance flexibility. Id. at 96. Per discussions with the Illinois EPA and USEPA, in a source-specific emission cap EIP, a source may establish abaseline based

on the average actual emissions over any two consecutive years during the pastten year period. The baseline mustthen be reducedby 10percentto demonstrate environmental benefit.

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The proposed amendmentwould combine the emissions from the fluid bed dryers and tunnel dryers. The average actual emissions from the fluid bed dryers and tunnel dryers for 1999 and 2000 were 22.9 tons peryearofVOM. See Exhibit 3. As discussed above, the allowable YOM emissions under the SubpartT exemption from the fluid bed dryers and tunnel dryers for 1999 and 2000 were (andremains) 45 tons peryear ofVOM. Therefore, the actual average emissions of22.9 tons peryear ofVOM for 1999 and 2000

are the lower ofthe actual or allowable emissions as requiredby the EIP guidance. The proposed amendmentwould set the emissions cap for the combined emissions from the fluid bed dryers and tunnel dryers at 10 percent less than the actual average emissions, i.e., 20.7 tons peryear, in order for such dryers to remain underthe exemption. Thus, the proposed amendmentwouldreduce the total allowable emissions from the two categories ofdryers by 24.3 tons peryear, as compared with the emissions allowed currently under the exemption. 

### B. Reasons for Proposed amendment 1. Technology Shift First, Abbott operates both tunnel dryers and fluid bed dryers during its manufacturing processes. In earlieryears, Abbott utilized tunnel dryers for most ofits processes. Tunnel dryers are an effective means ofdrying certainproducts, however, Abbotthas increased its use offluid bed dryers in recentyears because they are more efficientthan the tunnel dryers. In orderto manufacture its products in the most efficient

manner, Abbott expects thatthe preferential use offluid bed dryers will continue.

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2. General Flexibility Second, Abbottmanufactures its products using batchprocesses whereby the equipment (including the dryers) produces one product at a time in fixed batch sizes. Extensive equipment cleaning is requiredbetweenbatches ofdifferentproducts resulting in up to three days oflostproduction time; therefore, Abbottuses a campaign strategy to continue running batches ofthe same product consecutivelyto minimize cleaning time. As couldbe expected, the manufacturing processes involved in the production of differentproducts emit differing amounts ofVOM. As currently written, Section 218.480(b) can limit Abbott's ability to schedule the campaigns ofcertainproducts to maximize the efficiency ofthe processes. In otherwords, to ensure compliance with the
currentrunning 12-month total YOM limit on each dryer for a particularbatch, Abbott may be required to utilize the dryer with the least amount ofVOM emissions during the last 12 months, instead ofusing the dryer which is the most efficient from aproduction standpoint. Such selection ofdryers, based merely on the amount ofVOM that has been emitted from an individual dryer during the preceding 12 months, is an arbitrary and inefficient approach to scheduling the use ofAbbott's equipment and resources. Additionally, a campaign canutilize any ofthe fluid bed dryers; the dryer selected for a given campaign will depend on dryer availability and other factors. For example, Abbott's equipmentmust undergo stringent cleaning and preventative maintenance activities in accordance withUnited States Food and Drug Administration ("US FDA")

current GoodManufacturing Practice ("cGMP") guidelines. One fluid bed dryermay be temporarily out ofuse to allow for these activities or for unscheduled maintenance



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requirements. The most efficientmethod ofmanufacturing Abbott's products wouldbe
to use the dryer that is best suited to the requirements ofthe manufacturing schedule irrespective ofthe amount ofVOM thathas been emitted from that dryerin the past 12 months. So long as the combined YOM emissions from all ofthe dryers ofthattype are less than the amount allowed under Section 218.480(b), this method ofoperation would
notresult in any increased YOM emissions at the Facility. In fact, the proposed amendmentwouldprovide Abbott improvedproduction flexibility while lowering the total allowed Volatile Organic Material emissions from all the dryers combined. 

### E. Purpose and Effect The amendment groups the YOM emissions from the dryers for the purpose of meeting the emission requirements for the exemption from portions ofSubpartT and allows Abbott greater flexibility in its manufacturing processes. The proposed amendment would lower, by 24.3 tons peryear, the total amount ofVOM that is allowed
to be emittedby the affected dryers pursuantto the. SubpartT exemption. Further, the proposed amendmentwould allow Abbottto utilize the most efficientprocess unit for eachbatchprocess, irrespective ofrecentpast usage ofspecific equipment. 

### III. GEOGRAPIDC REGIONS AND SOURCES AFFECTED Since the proposed amendmentwould actually reduce the amount ofVOM emissions thatthe Facility is allowedto release and still be allowed to claim the Section 218.480(b) exemption, the geographic area and source affectedby this proposal is the Facility located in Libertyville Township, Lake County, Illinois and its surroundings.

8Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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### * * * * *

IV. TECHNICAL FEASIBILITYAND ECONOMIC REASONABLENESSIIMPACT AND AVAILABLE TREATMENT OR CONTROL OPTIONS The proposed amendment to 35 Ill. Admin. Code 

### § 218.480 will not impose any

new requirements on any affected source other than Abbott. 

### V. ENVIRONMENTAL IMPACT OF PROPOSED AMENDMENT As discussed herein, the proposed amendmentwould reduce the amount ofVOM emissions that the Facility is allowed to emitunder the Section 218.480(b) exemption to

an amount which is not only below the current allowable emissions, but also below historic actual emissions. Therefore, it is reasonable to assume that any environmental impact associated with the proposed amendment wouldbe a positive environmental impact. 

### VI. COMMUNICATION WITH INTERESTED PARTIES Abbott has had several discussions with the Illinois EPA and USEPA regarding the need for the proposed amendment. The USEPA suggested that a source-specific emission cap EIP may be an appropriate mechanism to accomplish Abbott's goal as described herein. The Illinois EPA has agreed that the proposed amendment is appropriate and that the amendment would notresult in an increase in allowable emissions. 

### VII. SYNOPSIS OF TESTIMONY Abbottplans to present testimony from Ms. Diane Beno, AP16 Plant Manager, as well as from Mr. Robert Wells, Manager, Air, Global Environmental Health & Safety.

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### * * * * *

This testimony will focus onthe need for the proposed amendmentbased onthe process changes and need for flexibility as described above. VIII. MATERIALS INCORPORATED The proposed amendment does not incorporate anymaterials by reference. IX. CERTIFICATION OF MOST RECENT REGULATION The provision thatis proposed for amendment is 35 Ill. Admin. Code § 218.480. Abbott certifies, by its counsel's signatures below, that the portion of35 Ill. Admin. Code § 218.480 cited in this proposal is the mostrecent version of35 Ill. Admin. Code § 218.480, as published onthe Board's web-site. http://www.ipcb.state.il.us/documents/dsweb/Get/Document-11929/ 

# x. CONSISTENCYWITH FEDERAL LAW The proposed amendmentis not inconsistentwiththe federal Clean AirAct or other federal air regulations. In fact, the proposed amendment is based directly on the USEPA ElP guidance. See Exhibit 2. The proposed regulatory revision will affect Illinois' State Implementation Program ("SIP"). Therefore, ifthe proposedregulatory amendment is approved, Illinois EPA will submit a SIP revision to the USEPA. XI. CONCLUSION Abbotthas discussed the proposed amendment with Illinois EPA. The proposed amendmentwould: (1) allow Abbottto use the combined actual emissions from its affected tunnel dryers and fluid bed dryers to determine the applicability ofSubpart T to these units; and, (2) decrease the overall YOM emissions thatwouldbe allowed from its tunnel dryers and fluid bed dryers as a group relating to the 35 Ill. Admin. Code Section

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### * * * * *

218.480(b) exemption, while increasing operational flexibility. The proposed amendmentwould not impose any new control requirements on any source other than Abbott orresultin any increase in emissions. WHEREFORE, for the reasons stated above, ABBOTT LABORATORIES hereby submits this regulatory proposal and requests the lllinois Pollution Control Board adopt these proposed amendments to 35 Ill. Admin. Code § 218.480. Respectfully submitted,

ABBOTT LABORATORIES,

Dated: September4, 2007

Katherine D. Hodge Gale W. Newton HODGE DWYER ZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, lllinois 62705-5776 (217) 523-4900 By: /s/ Katherine D. Hodge One ofits Attorneys

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### * * * * *

AFFIDAVIT

STATE OF ILLINOIS COUNTY OF

# h.Q.

# Ke- ) ) SS. ) Diane Beno, being first duly sworn on oath, affirms that, based upon appropriate inquiry, the facts setforth inthe Statement ofReasons above are true and correct.

# ~~ Diane Beno, AP16 PlantManager Abbott Laboratories 100 Abbott ParkRoad Abbott Park, Dlinois ZIP 847/937-1321 Subscribed and swornto before me

### thi~day 

## OrC\lljt1'6+' 2007.**EI.ctronl~ ~I~~**  =::"00'\**~':~** .Dfftc

.. S

..phl

....r4,2007

LEGEND: 

# o ABBOTT FROFERlY BOUNDARY FLUID BED DRYERS 

## *

TUNNEL DRYERS EXHIBIT I

AERIAL FHOTOGRAFH OF ABBOTT FARK AND VICINllY L1BERlYVILLE TOWNSHIF, ILLINOIS APPR.OXJMATE SCALE: I" -I QO(J.(J"

100 500 1000 2000 3000 

# @)Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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### * * * * *

United States Environmental Protection Agency Office of Air and Radiation EPA-452/R-01-001 January 2001 

# &EPA 

# Improving Air Quality with Economic Incentive Programs

# This document is not included herein. Given the volume of this document, EPA is opting not to make an electronic copy available in the docket. We have included an electronic copy of the document cover and the Table of Contents for information purposes. Readers interested in examining this document should contact: Steven Rosenthal (312) 886-6052 rosenthal.steven@epa.govElectronic Filing, Received, Clerk"s Office, September 4, 2007 

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### * * * * *

EPi\-452nR-01-001



# IMPROVING AIR QUALITY WITH ECONOMIC INCENTIVE PROGRAMS

Preparedbythe Innovative Strategies and Economics Group (MD-15) Air Quality Strategies and Standards Division Office ofi\ir 

### QualityPlanning and Standards U.S. Environmental Protection Agency Research Triangle Park, North Carolina 27711

U.S. ENVIRONMENTAL PROTECTION AGENCY Office ofi\ir 

### and Radiation Office ofi\ir 

### QualityPlanning and Standards January 2001Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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### * * * * *

Thispage intentionallyleftblank.Electronic Filing, Received, Clerk"s Office, September 4, 2007 

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TABLE OF CONTENTS Selecting andApproving EIPs 1.0 General 3 1.1 What does this Federal EIP guidance cover? 3 1.2 Who should follow this guidance? 5 1.3 Why should I develop an EIP? 5 1.4 What are the goals ofthis guidance? 8 1.5 How does this guidance affect the EPA's 1994 EIP rule? 8 1.6 How does this guidance apply to existingEIPs? 9 1.7 Whatprograms are not coveredby this guidance? 9 1.8 Whatis the general process for getting my EIP approved? 11 1.9 What does the EPAmean when it says this is guidance? 12 2.0 DefiIring anEIP

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 2.1 Whatis an EIP? 15 2.2 Whatpollutants are covered? 16 2.3 What sources may I include inmy EIP? 16 2.4 What are the objectives ofEIPs? 16 3.0 Selecting YourEIP Type 17 3.1 How do I selectthe type ofEIP that will workbestfor me? 17 3.2 Whom shouldI involve in selecting and developing myEIP? 28 3.3 How do I apply this guidance to a particulartype ofEIP? 29 Elements ofAll EIPs 4.0 Fundamental Principles ofAll EIPs 33 4.1 How mustmy EIP meetthe integrityprinciple? 34 4.2 How mustmy EIP meetthe equityprinciple? 45 4.3 How mustmy EIP meetthe environmental benefitprinciple? 49 5.0 CommonElements ofAll EIPS 53 5.1 Whatprovisions do I need to incorporate my EIP into my SIP? 53 5.2 How do I quantify the results ofmy EIP? 59 5.3 Whatfeatures mustI include inmy EIP to measure andtrackresults? 66 6.0 Elements ofAll Trading EIPs 73 6.1 What enforcementelements must 

### all trading EIPs contain? 73 6.2 Whatprovisions do I need inmy trading EIP to address specific pollutant effects? 76 6.3 Whatprovisions do I needinmy trading EIP to ensure it does notinterfere

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### * * * * ***~thotherprogrcrrns?** 

### 77 6.4 Whatprovisions do I needinmy trading EIP to 

### address uncertainty? 79 6.5 What otherprovisions do Ineedinmy trading EIP? 81 6.6 Are "emissionreductions" the same as "emissionreduction credits (ERCs)?" 87 7.0 Elements ofSpecific Trading EIPs 89 7.1 How do I selectthe appropriate trading EIP? 89 7.2 What otherprovisions do I need for my emission averaging EIP ? 91 7.3 Whatadditional provisions do I need formy source-specific emissioncap EIP? 94 7.4 Whatadditionalprovisions do I need formymulti-source emissioncap-and-trade EIP? 98 7.5 Whatadditional provisions do I need formy open-market trading EIP? 105 8.0 Elements ofFinancialMechanismEIPs 113 8.1 Whatprovisions mustall 

### financial mechanismEIPs contain? 113 9.0 Elements ofCleanAir

### InvestmentFunds 117 9.1 Why shouldI establish aCAlF? 118 9.2 How does a CAlF work? 118 9.3 How do CAlFs compare to 

### otherEIPs? 121 9.4 CanI use a CAlF to address environmentaljustice concerns? 123 9.5 How do I establish and implementa CAlF? 123 9.6 Whatprovisions must all CAlFs contain? 124 10.0 Elements ofPublic InformationEIPs ...........•.............................. 129 10.1 Whatprovisions mustall public informationprogrcrrns contain? 130 10.2 Are 

### "voluntarymeasures" progrcrrns different from EIPs? 131 Other Requirements for EIPs 

### 11.0 Getting Your EIP Approved 135 11.2 WhatmustI submitto 

### demonstratemy EIP is complete? 135 11.3 WhatmustI submitfor approval if

### mytradingprogrcrrninvolves more than 

### my State? 137 11.4 WhatmustI submitfor approval to 

### show my EIP is consistent**~th** 

### other applicable laws? 137 11.5 How long**~l** 

### ittake to 

### getmy EIP submittal approvedby the EPA? 138 11.6 Whatfinal actions canthe EPAtake onmy EIP SIP submittal? 138 11.7 What does itmean if

### the EPA does not :fully approve myEIP? 139 11.8 Whathappens if! implementmy EIP beforethe EPA approves it? 140 12.0 Running YourApprovedEIP 141 12.1 Whatare my responsibilities forrunning my EIP once itis approved? 141 12.2 HowmustIenforcemyEIP? 141

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12.3 How mustI evaluatemy EIP? 142 12.4 How mustI reconcile any problems? 142 12.5 How mustI update inventories? 143 

### OtherImportantInformationYou Need to Know 13.0 Additional Guidance ThatApplies to EIPs 147 13.1 What additional guidance must I use for specific EIPs? 147 14.0 Mobile Source Guidance You May Use Instead ofThis Guidance 149 14.1 What guidancemay I use instead ofthe EIP guidance? 149 15.0 Special Terms You Need to Know 153 15.1 Glossary 153 15.2 List ofacronyms 166 16.0 Appendices 171 16.1 Special Provisions for Areas Needing and Lacking Attainment 171 16.2 VOC EIPs involving hazardous airpollutants (HAPs) 175 16.3 Emission quantificationprotocols for OMTEIPs 188 16.4 Guidance onVoluntaty Emission Reduction Programs 199 16.5 Ensuring Adequate Public Participation 225 16.6 FLM NotificationRequirements 229 16.7 Area-wide RACTprovisions 231 16.8 Provisions for sources with Title V permits 232 16.9 Provisions for ozone inter-precursortrading 235 16.10 Provisions to ensure consistency withtransportation conformity 238 16.11 Provisions for localized increases ofcriteriapollutant andprecursor emissions 240 16.12 Provisions for inter-credittrading 242 16.13 Provisions for EIPs thatinclude RACT sources 243 16.14 Provisions fornew sourcereview andtrading 246 16.15 Provisions forbanking emissionreductions 249 16.16 Provisions for geographic trading acrossjurisdictionalboundaries 256 16.17 Safeguards for EIPs that allow the use ofold emissions reductions 258 16.18 Provisions for opt-in sources 260

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List ofTables 

### Table 1.1: EPARegionalAirDivisionDirectors 7 Table 3.1: Characteristics ofEIPs 18 Table 3.2: Which Sections ofthis Guidance ShouldIRead? 30 Table4.1(a): Programmatic IntegrityElements 37 Table 4.1(b): Programmatic IntegrityElementofSmplus for Trading EIPs 38 Table4.1(c): Programmatic IntegrityElementofSmplus for OtherEIPs 38 Table4.2(a): Source-Specific IntegrityElements 40 Table4.2(b): ComparisonofSource-Specific IntegrityElements forTrading EIPs 42 Table 4.2(c): Comparison ofSource Specific IntegrityElements for OtherEIPs 44 Table4.3(a):General Equity Principle forTrading EIPs 47 Table4.3(b): General EquityPrinciple for OtherEIPs 47 Table4.4(a): Environmental JusticeElementforTrading EIPs 49 Table4.4(b): EnvironmentalJusticeElementfor OtherEIPs 49 Table4.5(a): EnvironmentalBenefitPrinciple forTrading EIPs 51 Table4.5(b): EnvironmentalBenefitPrinciple for OtherEIPs 51 Table 7.1: Characteristics ofTrading EIPs 90 Table 10.1: Examples ofPublic InfonnationEIPs 130 Table 16.11: SignificantAnnual 

### Increases for CriteriaPollutants 240 Table 16.14: NSRRequirements 247

IV

# r' ZIEPAATTACHMENT**NO~_**

ILLINOIS POLLUTION CONTROL BOARD October4, 2007 IN THE MATTER OF: ) ) ABBOTT LABORATORIES' PROPOSED ) SITE SPECIFIC AMENDMENT TO ) APPLICABILITY SECTION OF ORGANIC ) MATERIAL EMISSION STANDARDS AND ) LIMITATIONS FOR THE CHICAGO AREA;) SUBPARTT: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b)) ) Proposed Rule. FirstNotice. 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 ofEnvironmental Protection Act (Act) (415 ILCS 28 (2006)), to allow it "additional operational flexibility" withregard to emissions from certain tunnel dryers and fluid bed dryers at its pharmaceutical manufacturing facility located in Libertyville Township, Lake County. Abbott also filed motions requesting the Board to waive the requirement for 200 signatures on its petition and to expedite consideration ofits requestby, among otherthings, ordering immediate publication ofthe rules for first notice under the Illinois Administrative Procedure Act (APA) (5 ILCS 100/1-1)(2006). 

### See, respectively, 35 Ill. Adm. Code Sections 102.202(g) and 101.512. To date, the Board has received no response to either motion from the Illinois Environmental Protection Agency (Agency) or any otherperson. In this order, the Board accepts the proposal for hearing, granting the motion to waive signature requirement. The Board denies the motion for expedited consideration, but authorizes first-notice publication ofthe proposal without comment on the proposal's merits. THE PROPOSAL Abbott owns apharmaceutical manufacturing facility located inLibertyville Township, Lake County, Illinois ("the Facility"). Abbott's operations are subjectto 35 Ill. Adm. Code, Subpart T - Pharmaceutical Manufacturing ("Subpart T"). As currently written, Subpart T, Section 218.480(b) ("Section 218.480(b)") contains certain exemptions that are only applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located at the Facility. Abbott is proposing to amend these site-specific exemptions by "capping" and lowering the overall emissions allowable under the exemptions from its tunnel dryers numbered #1, #2, #3 and #4, and fluid bed dryers numbered #1, #2 and #3, and calculating the amount of exempted emissions from the dryers based onthe actual combined emissions from the dryers. Abbottbelieves that, ifadopted, the proposed amendmentwould reduce the overall allowable2

emissions from these units while increasing Abbott's operational flexibility, by allowing it to make preferential use ofthe more efficient fluid bed dryers. MOTIONS Abbott first requests thatthe Board waive the requirement for 200 signatures on the petition, as required by 35 111. Adm. Code Section 102.202(g). 

### In support ofthis motion, Abbott cites various pastproceedings in which the Board has granted similarrequests. 

### In its motion to expedite (Mot. Exp.),Abbott also requests that the Boardproceed to APA first notice withoutreaching a decision on the merits, by accepting the regulatory language proposedby Abbott in this rulemaking proposal only for purposes offirst notice. Abbott also requests that the requisite hearing be scheduled as soon as possible in accordance with Section 28(a) ofthe Act. Mot. Exp. at 2-3. 

### In support ofthis request, Abbott asserts thatthe proposal is intended to increase efficiency in its use ofcertain fluidized bed and tunnel dryers while providing for lower allowable emissions from these dryers as a group. Abbot contends thatthe currentrule "requires Abbott to utilize its equipment and resources in a mannerthat is inefficient

... [causing] material prejudice to Abbott." Mot. Exp. at 2. Abbott states that the Agency has been contacted and has no disagreement with the proposed amendments. Abbott also cites to otherproceedings in which the Boardhas granted similarrequests. Abbott also states that ifmore information is needed that it will expeditiously provide it. 

### Id. at 3. DISCUSSION First, the Board finds that the petition meets the contentrequirements of35 Ill. Adm. Code 102.208 and 102.210 and is accepted for hearing. However, a review ofthe proposal reveals thatAbbott did not address the applicability of, orprovide the information requested in, the "published study or report" requirement ofSection 102.210(c). 35 Ill. Adm. Code 102.210(c); see also 35 Ill. Adm. Code 102.210(g). The Boardrequests thatAbbott address Section 102.21O(c), or its inapplicability, in writing, prior to any hearing scheduled in this proceeding or at such other time as directedby the hearing officer. Next, the Board grants the motion to waive the signature requirement ofSection 102.202(g). Lastly, the Board denies the motion for expedited consideration. Requests for expedited review are governedby Section 101.512 ofthe Board's rules, and must contain, interalia, a complete statement ofthe facts and reasons for the request. See 35 Ill. Adm. Code 101.512. 

### In acting on a motion for expeditedreview, the Board considers, at aminimum, all statutory requirements and whether ornot material prejudice will result from the motion being granted or denied. 35 Ill. Adm. Code 101.512(b). 

### In addition, the Board will only grant a motion for expedited review consistentwith available resources. See 35 Ill. Adm. Code 101.512(c).

# r

3

The Board does not discount Abbott's assertions that continued operations using less efficient drying processes is not optimal, and for the purposes ofthis motion accepts as true Abbott's assertions that actual emissions wouldbe lowered ifit operates under an amended rule as proposed. However, this does not give rise to "material prejudice" sufficient to allow the Board to grantAbbott's request as made. As noted, expeditedreview is granted consistent with decision deadlines and available resources. The Board currently has numerous open rulemaking dockets that demand immediate attention, as well as pressing cases that will keep the Board busy for several months. Due to attrition, Board staffing is atits lowest levels in some years. Even ifthe Board were to accept thatAbbott's claims amount to "material prejudice", the Board's limited resources in light ofits current and future decision deadlines render the granting ofa motion for expedited review unlikely in all but the most dire circumstances. However, the Board can authorize the first-notice publication ofthis proposal without comment on its merits. The Board notes that it has made minor, non-substantive changes to the text ofthe propoqed rule. The Board directs its hearing officer to expeditiously schedule hearing consistent with the Board's decision calendar and operational needs. The Board directs the Clerkto cause first-notice publication in the Illinois Registerofthe following proposed rule: TITLE 35: ENVIRONMENTAL PROTECTION SUBTITLE B: AIR POLLUTION CHAPTER I: POLLUTION CONTROL BOARD SUBCHAPTER c: EMISSIONS STANDARDS AND

LIMITATIONS FOR STATIONARY SOURCES PART 218 ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS FOR THE CHICAGO AREA

SUBPART A: GENERAL PROVISIONS Section 218.100 218.101 218.102 218.103 218.104 218.105 218.106 218.107 218.108 Introduction Savings Clause Abbreviations and Conversion Factors Applicability Definitions.","

. Test Methods and Procedures Compliance Dates Operation ofAfterburners Exemptions, Variations, and Alternative Means ofControl or Compliance Determinations218.109 218.110 218.111 218.112 218.113 218.114

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 218.181 218.182 218.183 218.184 218.185 218.186

Section 218.204 218.205 218.206 218.207 218.208 4 Vapor Pressure ofVolatile Organic Liquids Vapor Pressure ofOrganic Material or Solvent VaporPressure ofVolatile Organic Material Incorporations by Reference Monitoring for Negligibly-Reactive Compounds Compliance with Permit Conditions SUBPART B: ORGANIC EMISSIONS FROM STORAGE AND LOADING OPERATIONS Applicability for VOL Control Requirements for Storage Containers ofVOL Storage Containers ofVPL Loading Operations Petroleum Liquid Storage Tanks External Floating Roofs Compliance Dates Compliance Plan (Repealed) Testing VOL Operations Monitoring VOL Operations Recordkeeping and Reporting for VOL Operations SUBPART C: ORGANIC EMISSIONS FROM MISCELLANEOUS EQUIPMENT Separation Operations Pumps and Compressors Vapor Blowdown Safety ReliefValves SUBPARTE: SOLVENT CLEANING Solvent Cleaning in General Cold Cleaning Open Top Vapor Degreasing Conveyorized Degreasing Compliance Schedule (Repealed) Test Methods SUBPART F: COATING OPERATIONS Emission Limitations Daily-Weighted Average Limitations Solids Basis Calculation Alternative Emission Limitations Exemptions from Emission Limitations218.209 218.210 218.211 218.212 218.213 218.214 218.215 218.216 218.217

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

Section 218.421 218.422 218.423 218.424 218.425 218.426 218.427 218.428 218.429 5 Exemption from General Rule on Use ofOrganic Material Compliance Schedule Recordkeeping and Reporting Cross-Line Averaging to Establish Compliance for Coating Lines Recordkeeping and Reporting for Cross-Line Averaging Participating Coating Lines Changing Compliance Methods Wood Furniture Coating Averaging Approach Wood Furniture Coating Add-On Control Use Wood Furniture Coating Work Practice Standards 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 Prior to March 15, 1996 Emission Limitations and Control Requirements for Lithographic Printing Lines On and After March 15, 1996 Compliance Schedule for Lithographic Printing On and After March 15, 1996 Testing for Lithographic Printing On and After March 15, 1996 Monitoring Requirements for Lithographic Printing Recordkeeping and Reporting for Lithographic Printing 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 Devices218.430 218.431 218.432 218.433 218.434 218.435 218.436

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 218.480 218.481 218.482 218.483 218.484 218.485 218.486 218.487 218.488 6 Compliance Date (Repealed) Applicability Control Requrrements Performance and Testing Requirements Monitoring Requirements Recordkeeping and Reporting Requirements Compliance Date SUBPART R: PETROLEUM REFINING AND RELATED INDUSTRIES; ASPHALT MATERIALS Petroleum Refinery Waste Gas Disposal Vacuum Producing Systems Wastewater (Oil/Water) Separator Process Unit Turnarounds Leaks: General Requirements Monitoring Program Plan for Leaks Monitoring Program for Leaks Recordkeeping for Leaks Reporting for Leaks Alternative Program for Leaks Sealing Device Requirements Compliance Schedule for Leaks Compliance Dates (Repealed) SUBPART S: RUBBER AND MISCELLANEOUS PLASTIC PRODUCTS Manufacture ofPneumatic Rubber Tires Green Tire Spraying Operations Alternative Emission Reduction Systems Emission Testing Compliance Dates (Repealed) Compliance Plan (Repealed) SUBPART T: PHARMACEUTICAL MANUFACTURING Applicability Control ofReactors, Distillation Units, Crystallizers, Centrifuges and Vacuum Dryers Control ofAir Dryers, Production Equipment Exhaust Systems and Filters Material Storage and Transfer In-Process Tanks Leaks Other Emission Units Testing Monitoring for Air Pollution Control Equipment

# r

7

218.489 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 218.581 218.582 218.583 218.584 218.585 218.586 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 Section 218.601 218.602 218.603 218.604 Perchloroethy1ene Dry Cleaners (Repealed) Applicability (Repealed) Leaks (Repealed) Compliance Dates (Repealed)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

Section 218.680 218.686 218.688 218.690 218.692 8 Compliance Plan (Repealed) Exception to Compliance Plan (Repealed) Standards for Petroleum Solvent Dry Cleaners Operating Practices for Petroleum Solvent Dry Cleaners Program for Inspection and Repair ofLeaks Testing and Monitoring Applicability for Petroleum Solvent Dry Cleaners Compliance Dates (Repealed) Compliance Plan (Repealed) SUBPART AA: PAINT AND INK MANUFACTURING Applicability Exemption for Waterbase Material and Heatset Offset Ink Permit Conditions (Repealed) Open Top Mills, Tanks, Vats or Vessels Grinding Mills Storage Tanks Leaks Clean Up Compliance Schedule Recordkeeping and Reporting SUBPART BB: POLYSTYRENE PLANTS Applicability Emissions Limitation at Polystyrene Plants Emissions Testing SUBPART CC: POLYESTER RESIN PRODUCT MANUFACTURING PROCESS Applicability Control Requirements Compliance Schedule Testing Recordkeeping and Reporting for Exempt Emission Units Recordkeeping and Reporting for SubjectEmission Units SUBPART DD: AEROSOL CAN FILLING Applicability Control Requirements Testing Recordkeeping and Reporting for Exempt Emission Units Recordkeeping and Reporting for SubjectEmission UnitsSection 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 218.920 218.923 218.926 218.927 9

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 ofSubpart BB (Renumbered) Emissions Limitation at Polystyrene Plants (Renumbered) Compliance Date (Repealed) Compliance Plan (Repealed) Special Requirements for Compliance Plan (Repealed) Emissions Testing (Renumbered) SUBPART PP: MISCELLANEOUS FABRICATED PRODUCT MANUFACTURING PROCESSES Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule218.928 218.929

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 10 Testing Cementable and Dress or Performance Shoe Leather SUBPART QQ: MISCELLANEOUS FORMULATION MANUFACTURING PROCESSES Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing

SUBPART RR: MISCELLANEOUS ORGANIC CHEMICAL MANUFACTURING PROCESSES Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing SUBPART TT: OTHER EMISSION UNITS Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing SUBPART UU: RECORDKEEPING AND REPORTING Exempt Emission Units SubjectEmission Units 2l8.APPENDIX A: 2l8.APPENDIX B: 2l8.APPENDIX C: 2l8.APPENDIX D: 2l8.APPENDIX E: 2l8.APPENDIX G: 2l8.APPENDIX H: List ofChemicals Defining Synthetic Organic Chemical and Polymer Manufacturing YOM Measurement Techniques for Capture Efficiency (Repealed) Reference Methods and Procedures Coefficients for the Total Resource Effectiveness Index (TRE) Equation List ofAffected Marine Terminals TRE Index Measurements for SOCMI Reactors and Distillation Units Baseline YOM Content Limitations for SubpartF, Section 218.212 Cross-Line Averaging11

AUTHORITY: Implementing Section 10 and authorizedby Sections 27,28,28.5 ofthe Environmental Protection Act [415 ILCS 5110 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 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 April 8, 2003; amended in R04-12/20 at 30 Ill. Reg. 9684, effective May 15,2006; amended in R06-21 at 31 Ill. Reg. 7086, effective April 30, 2007; amended in R08-8 at 31 Ill. Reg. , effective

_ SUBPART T: PHARMACEUTICAL MANUFACTURING

Section 218.480 Applicability a) The rules ofthis Subpart, except for Sections 218.483 through 218.485 ofthis Part, apply to all emission units ofVOM, including but not limited to reactors, distillation units, dryers, storage tanks for VOL, equipment for the transfer of VOL, filters, crystallizers, washers, laboratory hoods, pharmaceutical coating operations, mixing operations and centrifuges used in manufacturing, including packaging, ofpharmaceuticals, and emitting more than 6.8 kg/day (15 lbs/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 ifYOM emissions from the emission unit exceed 45.4 kg/day (100 lbs/day). b) Notwithstanding subsection (a) ofthis Section, the air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located in Libertyville Township, Lake County, Illinois shall be exempt from the rules ofthis Subpart, except for Sections 218.483 through 218.485, ifemissions ofVOM not vented 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, forffi each fluid bed dryer: 4,535 kg/year (5.0 tons/year);12 3) Except as set forth in subsection 218.480(b)(4) ofthis Section, for Fef each tunnel dryer: 6,803 kg/year (7.5 tons/year); and 1} For fluid bed dryers #1, #2, and #3 and for tunnel dryers #1, #2, #3, and #4, the combined total annual emissions from the dryers listed in this subsection 218.480(b)(4) shall not exceed 18,779 kg/year (20.7 tons/year). [BOARD NOTE: tunnel dryers are otherwise referred to as warm air dryers]; and**4~)** For eachAccelacota: 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 ormore sources exceed 45.4 kg/day (100 Ibs/day). d) No owner or operator shall violate any condition in apermit 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 shallremain subject to the provisions ofthis Subpart at all times. f) Emissions subjectto this Subpart shall be controlled at all times consistentwith the requirements set forth in this Subpart. g) Any control device required pursuantto this Subpart shall be operated at all times when the source it is controlling is operated. h) Determinations ofdaily and annual emissions forpurposes ofthis Section shallbe made using both data on the hourly emission rate (or the emissions per unit of throughput) and appropriate daily and annual data from records ofemission unit operation (ormaterial throughput ormaterial consumption data). In the absence ofrepresentative test datapursuantto Section 218.487 ofthis Part for the hourly emission rate (or the 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), incorporated by reference in Section 218.112 ofthis Part. (This subsection shall not affect the Agency's orthe USEPA's authority to require emissiontests to be performed pursuantto Section 218.487 ofthis Part.)13

i) Equipment and operations emitting YOM at a source subject to subsection (a) or (c) ofthis Section and used to produce pharmaceutical products or a pharmaceutical-like product such as ahormone, enzyme, or antibiotic, shall be deemed to be engaged in the manufacture ofpharmaceuticals for the purposes of this Subpart. (Source: Amended at 31 Ill. Reg. , effective --') IT IS SO ORDERED. MemberA. S. Moore abstained. I, John T. Therriault, Assistant Clerk ofthe Illinois Pollution Control Board, certify that the Board adopted the above order on October 4,2007, by a vote of3-0.

John T. Therriault, Assistant Clerk Illinois Pollution Control BoardDearDirectorLavin: 

# ILLINOIS POLLUTION CONTROL BOARD tEPAATTACHMENT NO.



### RBcml D

OlERK'SO



## OCT 182007 STATE OF ILLINOIS Pollution 

### Control Board October 18,2007 Jack Lavin, Director DepartmentofCommerce andEconomic Opportunity 620 East Adams Street, 

### S-6 Springfield, lllinois 62704 Re: Request for Economic Impact Study for: Abbott Laboratories' 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)

In response to Abbott's request, the Board accepted the proposal forhearing, and frrst notice publication, but did notcomment onthe merits ofthe Abbott proposal. As Abbottwould like a decision onthe request as soon as possible, the Board is in the process ofscheduling a hearing in the nearfuture. On October4, 2007, the Board accepted a proposal forhearing inAbbott Laboratories' Proposed Site Specific Amendment to Applicability Section of Organic Material Emission Standards and Limitations for the Chicago Area: Subpart T: Pharmaceutical Manufacturing (35 TIL Adm. Code 218.480(b» (R08-8). I am writing to request that yourDepartment conduct an economic impact study concerning this site-specific proposal. The rulemaking is based on a proposal filed byAbbott Laboratories to amend the Board's airregulations. The Board is inthe process ofscheduling hearings in this rulemaking. AbbottLaboratories proposedthese site-specific amendments for its pharmaceutical manufacturing facility located inLibertyvilleTownship, Lake County. 35 

### lil. Adm. Code 218.480(b) contains certain exemptions that are only applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas. Abbott is proposing 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 efficientfluid bed dryers. 

# r

# ILLINOIS POLLUTION CONTROL BOARD

Since 1998, Section 27 (b) ofthe Environmental ProtectionActhas required the Board to: 1) "requestthatthe Department ofCommerce and Economic Opportunity (fonnerlythe DepartmentofCommerce and CommunityAffairs) conduct a study ofthe economic impact ofthe proposedrules. The Departmentmay within 30 to 45 days ofsuchrequestproduce a study ofthe economic impact ofthe proposed rules. At a minimum, the economic impact study shall address a) economic, environmental, andpublichealthbenefits thatmaybe achieved through compliance with the proposedrules, b) the effects ofthe proposedrules on employmentlevels, commercial productivity, the economic growth ofsmall businesses with 100 or less employees, and the State's overall economy, and c) the costperunit ofpollutionreduced and the variability ofcompanyrevenues expectedto be usedto implementthe proposedrules; and (2) conduct at least one publichearing onthe economic impact ofthose rules. At least

### 20 days before thehearing, theBoard shall notify the public of thehearing and make the economic impact study, orthe Department of Commerce andEconomic Opportunity's explanationfor not producing an economic impact study, available to thepublic. Suchpublic hearing maybe held simultaneously or as a part ofanyBoardhearing considering such new rules'" 415 ILCS 5/27(b) (2004). 

### If

### I, ormy staff, canprovide you with any additional information, pleaselet me know. Thankyou in advance for yourpromptresponse. Sincerely, 

# ))

.**..,~fiI~** G. Tanner Girard Acting Chairman Pollution Control Board

cc: Warren Ribley, DCEO 

### John T. Therriault, AssistantClerkofthe BoardIEPAATTACHMENT NO

.

# ...:i. RECEIVED

CLERK'S OFFICE



## OCT 1. 'l

## 2007 STATE OF ILliNOIS Pollution control 

### Board 

# OFFICE OF THE SECRETARY OF STATE JESSEWHITE. Secretary ofState 10/17/2007
POLLUTION CONTROL BOARD JAMES R THOMPSON CENTER 100 W RANDOLPH ST STE 11-500 DOROTHY GUNN CHICAGO, IL 60601

Dear DOROTHY GUNN Your rules Listed below met our codification standards and have been published in Volume 31, Issue 43 of the Illinois Register, dated 10/26/2007. PROPOSED RULES Organic Material Emission Standards and Limitations forthe Chicago Area 35 III. Adm. Code 218 Point OfContact:Erin Conley Page 14581 Ifyou 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

### ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT 1) Heading ofthe Part: Organic Material Emission Standards and Limitations for the Chicago Area 2) Code Citation: 35 Ill. Adm. Code Part 218 3) 

### SectionNumbers: 218,480 Proposed Action: Amend 4) Statutory Authority: Implementing Section 10 and authorized by Sections 27 and 28 of the Environmental Protection Act [415 ILCS 5/10,27

### and 28] 5) A Complete Description ofthe Subjects and Issues Involved: For a more detailed discussion ofthese amendments, seethe Board's October 4, 2007 opinion and orderin docket R08-8: Abbott Laboratories' Proposed Site Specific Amendmentto Applicability Section ofOrganic Material Emission Standards and Limitations for the Chicago Area: Subpart T: Pharmaceutical Manufacturing <35 Ill. Adm. Code 218,480(b)) (R08-8). Abbott Laboratories proposed site-specific amendments for its pharmaceutical manufacturing facility located in Libertyville Township, Lake County. 35 Ill. Adm. Code 218,480(b) contains certain exemptions that are only applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas. Abbott is proposing 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 it to make preferential use ofthe more efficientfluid bed dryers. In response to Abbott's request, the Board accepted the proposal for hearing, and first notice publication, but does not comment on the merits ofthe Abbott proposal. 6) Published studies orreports. and sources ofunderlying data. used to compose this rulemaking: None presently identified. 7) Will this proposed rulemaking replace an emergency rule currently in effect? No 8) Does this rulemaking contain an automatic repeal date? No RECEIVED 

## OCT 152007 50S-CODE DIV.

### ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT 9) Does this proposed rulemaking contain incorporations by reference? No 10) Are there any otherproposed amendments pending onthis Part? No 11) Statement ofStatewide Policy Objectives: This proposed rule does not create or enlarge a State mandate, as defined in Section 3(b) ofthe State Mandates Act. [30 ILCS 805/3(b) (2006)] 12) Time, Place, and Manner in which interestedpersons may comment on this proposed rulemaking: The Board is in the process ofscheduling a hearing in the rulemaking. Additionally, the Board will accept written public comment on this proposal for 45 days after the date of publication in the Illinois Register. 

### Comments should reference DocketR08-8 and be addressed to: Clerk's Office Illinois Pollution Control Board 100 W. Randolph St., Suite 11-500 Chicago, IL 60601 Interested persons may request copies ofthe Board's opinion and orderby calling the Clerk's office at 312-814-3620, or may download copies from the Board's Web site at www.ipcb.state.il.us. Formore information, contacthearing officer Kathleen M. Crowley at 312/814-6929 or email atcrowlek@ipcb.state.il.us. 13) Initial Regulatory Flexibility Analysis: A) Types ofsmall businesses, small municipalities and not for profit corporations affected: This proposed rulemaking is site specific and will only impactAbbott Laboratories. B) Reporting, bookkeeping or other procedures required for compliance: This rulemaking does not impose any additional reporting orrecordkeeping requirements. C) Types ofProfessional skills necessary for compliance: No professional skills beyond those currently required by the existing state and federal airpollution control regulations applicable to affected source will be required.ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT 14) Reason this rulemaking was not included in the two mostrecentregulatory agendas: The Board did not anticipate that Abbott Laboratories would request this site-specific relief. The full text ofthe Proposed Amendmentbegins on the next page:Section 218.100 218.101 218.102 218.103 218.104 218.105 218.106 218.107 218.108 218.109 218.110 218.111 218.112 218.113 218.114

Section 218.119 218.120 218.121 218.122 218.123 218.124 218.125 ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT TITLE 35: ENVIRONMENTAL PROTECTION SUBTITLE B: AIR POLLUTION CHAPTER I: POLLUTION CONTROL BOARD SUBCHAPTER c: EMISSIONS STANDARDS AND LIMITATIONS FOR STATIONARY SOURCES PART 218 ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS FOR THE CHICAGO AREA

SUBPART A: GENERAL PROVISIONS Introduction Savings Clause Abbreviations and Conversion Factors Applicability Definitions Test Methods and Procedures Compliance Dates Operation ofAfterburners Exemptions, Variations, and Alternative Means ofControl or Compliance Determinations Vapor Pressure ofVolatile Organic Liquids Vapor Pressure ofOrganic Material or Solvent Vapor Pressure ofVolatile Organic Material Incorporations by Reference Monitoring forNegligibly-Reactive Compounds Compliance with Permit Conditions SUBPART B: ORGANIC EMISSIONS FROM STORAGE AND LOADING OPERATIONS Applicability for VOL Control Requirements for Storage Containers ofVOL Storage Containers ofVPL Loading Operations Petroleum Liquid Storage Tanks External Floating Roofs Compliance 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 PROPOSED AMENDMENT Compliance Plan (Repealed) Testing VOL Operations Monitoring VOL Operations Recordkeeping and Reporting for VOL Operations SUBPART C: ORGANIC EMISSIONS FROM MISCELLANEOUS EQUIPMENT Separation Operations Pumps and Compressors Vapor Blowdown Safety ReliefValves SUBPART E: SOLVENT CLEANING Solvent Cleaning in General Cold Cleaning Open Top Vapor Degreasing Conveyorized Degreasing Compliance Schedule (Repealed) Test Methods SUBPART F: COATING OPERATIONS Emission Limitations Daily-Weighted Average Limitations Solids Basis Calculation Alternative Emission Limitations Exemptions from Emission Limitations Exemption from General Rule on Use 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 WorkPractice 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 CONTROL BOARD NOTICE OF PROPOSED 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 and Rotogravure 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 After March 15, 1996 Compliance Schedule for Lithographic Printing On and After March 15, 1996 Testing for Lithographic Printing On and After March 15, 1996 Monitoring Requirements for Lithographic Printing Recordkeeping and Reporting for Lithographic Printing SUBPART Q: SYNTHETIC ORGANIC CHEMICAL AND POLYMER MANUFACTURING PLANT General Requirements Inspection Program Plan for Leaks Inspection Program for Leaks Repairing Leaks Recordkeeping for Leaks Report for Leaks Alternative Program for Leaks Open-Ended Valves Standards for Control Devices Compliance Date (Repealed) 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 218.480 218.481 218.482 218.483 218.484 218.485 218.486 218.487 ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT Recordkeeping and Reporting Requirements Compliance Date SUBPART R: PETROLEUM REFINING AND RELATED INDUSTRIES; ASPHALT MATERIALS Petroleum Refinery Waste Gas Disposal Vacuum Producing Systems Wastewater (Oil/Water) Separator Process Unit Turnarounds Leaks: General Requirements Monitoring Program Plan for Leaks Monitoring Program for Leaks Recordkeeping for Leaks Reporting for Leaks Alternative Program for Leaks Sealing Device Requirements Compliance Schedule for Leaks Compliance Dates (Repealed) SUBPART S: RUBBER AND MISCELLANEOUS PLASTIC PRODUCTS Manufacture ofPneumatic Rubber Tires Green Tire Spraying Operations Alternative EmissionReduction Systems 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 EmissionUnits TestingILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT 218.488 218.489 Monitoring for AirPollution 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: AGRICULTIJRE 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 218.581 218.582 218.583 218.584 218.585 218.586 Bulk Gasoline Plants Bulk Gasoline Terminals Gasoline Dispensing Operations

- Storage Tank Filling Operations Gasoline Delivery Vessels Gasoline Volatility Standards Gasoline Dispensing Operations

- Motor Vehicle Fueling OperationsSection 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 ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT

SUBPART Z: DRY CLEANERS Perchloroethylene Dry Cleaners (Repealed) Applicability (Repealed) Leaks (Repealed) Compliance Dates (Repealed) Compliance Plan (Repealed) Exception to Compliance Plan (Repealed) Standards for Petroleum Solvent Dry Cleaners Operating Practices for Petroleum SolventDry Cleaners Program for Inspection and Repair ofLeaks Testing and Monitoring Applicability for Petroleum Solvent Dry Cleaners Compliance Dates (Repealed) Compliance Plan (Repealed) SUBPART AA: PAINT AND INK MANUFACTURING Applicability Exemption for Waterbase Material and Heatset OffsetInk Permit Conditions (Repealed) Open Top Mills, Tanks, Vats or Vessels Grinding Mills Storage Tanks Leaks Clean Up Compliance Schedule Recordkeeping and Reporting SUBPART BB: POLYSTYRENE PLANTS Applicability Emissions Limitation atPolystyrene Plants Emissions Testing SUBPART CC: POLYESTER RESIN PRODUCT MANUFACTURING PROCESS Applicability218.666 218.667 218.668 218.670 218.672

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 ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT Control Requirements 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 SubjectEmission Units SUBPARTFF: 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: MOTORVEHICLE REFINISHING Emission Limitations Alternative Control Requirements Equipment Specifications Surface Preparation Materials Work Practices218.788 218.789 218.790 218.791 218.792 218.875 218.877 218.879 218.881 218.883 218.886

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 218.960 218.963 218.966 218.967 218.968 ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT Testing Monitoring and Recordkeeping for Control Devices General Recordkeeping and Reporting (Repealed) Compliance Date Registration Applicability ofSubpart BB (Renumbered) Emissions Limitation at Polystyrene Plants (Renumbered) Compliance Date (Repealed) Compliance Plan (Repealed) Special Requirements for Compliance Plan (Repealed) Emissions Testing (Renumbered)

SUBPART PP: MISCELLANEOUS FABRICATED PRODUCT MANUFACTURING PROCESSES Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing Cementable and Dress or Performance Shoe Leather SUBPART 

### QQ: MISCELLANEOUS FORMULATION MANUFACTURING PROCESSES Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing

SUBPART RR: MISCELLANEOUS ORGANIC CHEMICAL MANUFACTURING PROCESSES Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule TestingILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT SUBPART IT: OTHER EMISSION UNITS Section 218.980 218.983 218.986 218.987 218.988

Section 218.990 218.991 Applicability Permit Conditions (Repealed) Control Requirements Compliance Schedule Testing SUBPART UU: 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 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, Section 218.212 Cross-Line Averaging AUTHORITY: Implementing Section 10 and authorized by Sections 27, 28, and 28.5 ofthe Environmental Protection Act [415 ILCS 5110,27, 28,and 28.5]. SOURCE: Adopted at R91-7 at 15 Ill. Reg. 12231, effective August 16, 1991; amended in R91- 24 at 16 Ill. Reg. 13564, effective August 24, 1992; amended in R91-28 and R91-30 at 16 Ill. Reg. 13864, effective August 24, 1992; amended 

### in R93-9 at 17 Ill. Reg. 16636, effective September 27, 1993; amended in R93-14 at 18 Ill. Reg. at 1945, effective January 24, 1994; amended in R94-12 at 18 Ill. Reg. 14973, effective September 21, 1994; amended in R94-15 at 18 Ill. Reg. 16392, effective October 25, 1994; amended in R94-16 at 18 Ill. Reg. 16950, effective November 15, 1994; amended in R94-21, R94-31 and R94-32 at 19 Ill. Reg. 6848, effective May 9, 1995; amended in R94-33 at 19 Ill. Reg. 7359, effective May 22, 1995; amended 

### in R96-13 at 20 Ill. Reg. 14428, effective October 17, 1996; amended in R97-24 at 21 Ill. Reg. 7708, effective June 9, 1997; amended in R97-31 at 22 Ill. Reg. 3556, effective February 2, 1998; amended in R98-16 at 22 Ill. Reg. 14282, effective July 16, 1998; amended in R02-20 at 27 Ill. Reg 7283, effective April 8, 2003; amended in R04-12/20 at 30 Ill. Reg. 9684,ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT 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 butnot limitedto reactors, distillation units, dryers, storage tanks for VOL, equipmentfor 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 lbs/day). b) Notwithstanding subsection (a) ofthis Section, the air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located in Libertyville Township, Lake County, Illinois shall be exempt from the rules ofthis Subpart, exceptfor 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 setforth 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) oftrus Section. forFef eachtunnel dryer: 6,803 kg/year (7.5 tons/year); 

### and For fluid bed dryers #1, #2, and #3 and for tunnel dryers #1, #2, #3. and #4, the combined total annual emissions from the dryers listed in this subsection 218.480(b)(4) shall notexceed 18.779 kg/year (20.7 tons/year). [BOARD NOTE: tunnel dryers are otherwise referredto as warm air dryers]; andILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT**4~)** For eachAccelacota: 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 (15Ibs/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 lbs/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 that becomes 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 pursuantto 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 of throughput) and appropriate daily and annual data from records ofemission unit operation (or material throughput or material consumption data). In the absence ofrepresentative test data pursuantto Section 218.487 ofthis Part for the hourly emission rate (or the 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), incorporated by reference in Section 218.112 ofthis Part. (This subsection shall not affectthe Agency's or the USEPA's authority to require emission tests 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 producepharmaceutical products or a

### ILLINOIS REGISTER POLLUTION CONTROL BOARD NOTICE OF PROPOSED AMENDMENT pharmaceutical-likeproduct such as ahormone, enzyme, or antibiotic, shall be deemed to be engaged in the manufacture ofpharmaceuticals for the purposes of this Subpart. (Source: Amended at 32 Ill. Reg. :, effective. --')