### ILLINOIS POLLUTION CONTROL BOARD January 31, 2008 IN THE MATTER OF: ) ) 

### ABBOTT LABORATORIES' PROPOSED ) SITE SPECIFIC AMENDMENT TO ) APPLICABILITY SECTION OF ORGANIC ) MATERIAL EMISSION STANDARDS AND ) LIMITATIONS FOR THE CHICAGO AREA; ) SUBPARTT: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b» R08-8 (Rulemaking

- Air) IEPAATTACHMENT NO. 

# 5 ReCEIVED

CLERK'S OFFICE



## JAN 

# 3 1

# 2008 ;;:)STATE OF'LUNQ'S



### . Ollutl(In 

## Contro'Board

NOTICE OF HEARING DATE, TIME, PLACE: FRIDAY, MARCH 7, 2008, 1:00 p.m. Village Hall, Village ofLibertyville 118 W. Cook Street-SecondFloor Libertyville, I11inois

PURPOSE OF HEARING: ATTENDING BOARD MEMBER: HEARING OFFICER: Merit and economic Nicholas J. Melas Kathleen M. Crowley



### HEARING OFFICER ORDER Procedural History On September4,2007, Abbott Laboratories (Abbott) filed a proposal for site-specific rulemaking pursuant to Section 28 ofEnvironmental Protection Act (Act) (415 ILCS 5/28 (2006», to allow it "additional operational flexibility" with regard to emissions from certain tunnel dryers and fluid bed dryers at its pharmaceutical manufacturing facility (the Facility) located in Libertyville Township, Lake County. Abbott's operations are subject to 35 Ill. Adm. Code, Subpart T - Pharmaceutical Manufacturing (Subpart T). As currently written, Subpart T in Section 218.480(b) contains certain exemptions that are only applicable to Abbott's air suspension coater/dryer, fluid bed In**eomplial1~e** with the Americans With Disabilities Act and otherapplicable federal and State laws. the hearings will be accessible to individuals with disabilities_ Persons requiring auxiliary aids should conlact John T. Therriault. Assistant Clerk ofthe Board. 100 West Randolph Streel. Suite 11-500. Chieagll. Illinois 6060I, at telephone number (312) l1l4-3620. or 'l'DD number0 12) 814-6032. at least live days before the pUI1icuInr hearing.

### 2 dryers, tunnel dryers, and Accelacotas located at the Facility. Abbott is proposing to amend these site-specific exemptions by "capping" and loweringthe 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. Abbott believes 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 efficient fluid bed dryers. In an October4, 2007 order, the Board accepted theproposal for hearing. The Board also authorized publication ofthe proposal (without comment on the proposal's merits) in the l11inois Register as required by the Illinois Administrative Procedure Act (IAPA), 5 ILCS 100 et seq. (2006). The proposed rules were published at 31 Ill. Reg. 14581 (October 26,2007). No public comments orrequests for hearing were received during the IAPA first-notice public comment period, which ended December 10, 2007. On October 18, 2007, as required underSection 27(b)(1) ofthe Act, 415 ILCS 5/27(b)(1)(2006), the Boardrequested thatthe DepartmentofCommerce and Economic Opportunity (DCEO) conduct a studyofthe economic impactoftheproposedrules. DCEO has not responded to that request, and has not submitted a study. ByletterofOctober 19,2007, the Joint Committee on Administrative Rules (JCAR) requested the Board to make an analysis ofthe economic andbudgetaryeffects oftheproposed rule under Section 5-40(c) ofthe IAPA (5 ILCS 100/5-40(c)(2006». The Boardmust submitthe analysis along with its submission ofthe rule for lCAR's second-notice review underthe IAPA. Hearing and PrefilingDeadlines As noted above, the hearing inthis rulemaking 

## will be held in Libertyville on March 7, 2008, beginning at 1:00p.m. Both the technicaljustification andeconomic impactoftherules will be addressed atthis hearing, as the Boardpresentlydoes not intend to schedule anotherhearing. See Section 27 (b)ofthe Act, 415ILCS 5/27(b) (2006) and Section 102.414 ofthe Board's procedural rules, 35 Ill. Adm. Code 102.414. As proponent, Abbott 

## will first present testimony and exhibits in support ofits proposal; and answerquestions posed by the Illinois Environmental Protection Agency (IEPA) and any otherhearing participants. Then, the IEPA, followed by any otherhearingparticipants, may presenttestimony and exhibits concerning the proposed rule. All participants are requested to address economic and budgetary effects issues, to provide the Board with a record on which to address lCAR's concerns. Abbott, the tEPA, and any otherpersons who wish to testify at the hearing must prefile theirtestimony and anyrelated exhibits with the Boardno laterthan February 22, 2008. See 35 Ill. Adm. Code 102.424. The "mailbox rule" (35 Ill. Adm. Code 101.300(b)(2» does not apply

### 3



### to this filing-therefore, the Clerk ofthe Board must receive the prefiled testimonyby February 22,2008. In the interests ofhearing efficiency, participants are requested, but are not required. to advise one anotherin advance ofhearing ofquestions they may wish to ask based onthe prefiled testimony. Timelyprefiled testimony will be entered into the record as ifread. Those who prefile must be prepared to provide oral summaries oftheirprefiled testimony at hearing. Others who do not prefile maytestify only as timepermits. All persons who testify will beswom and subject to questioning. Abbott's proposal and various otherfilings in this rulemaking maybe obtained on the Board's Web Site through the Clerk's Office On-Line (COOL) at www.ipcb.statc.il.us. Please note thatprefiledtestimony maybe filed through COOL. Any questions about electronic filing through COOL shouldbe directed to the Clerk's Office at (312) 814-3629. Prefiled testimony filed with the Board must also be served on those persons onthe Service List. Before filing with the Clerk, please check with Don Brown at (312) 814-3461 or hrownd(ii!ipcb.state.il.us orthe hearing officerto ensure that you have the most recent version of the Service List. At the close ofhearing, the hearing officerwill set a date bywhich the record will close and all public comments mustbe submitted. See 35 Ill. Adm. Code 102.108. As the Board is aware that Abbottwould appreciate Board decision-making as soon as possible, the posthearing commentperiodwill notbe lengthy unless unanticipated circumstances dictate otherwise. IT IS SO ORDERED.

# ~P1.~ Kathleen M. Crowley Hearing Officer, Illinois Pollution Control Board 100WestRandolph Street, Suite 11-500 Chicago, Illinois 60601 (312) 814-6929 crowlek@ipcb.state.il.us

### JEPAATTACHMENT NO. 

### Electronic Filing· Received, Clerk"s Office, February 22, 2008

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: ) 

### ) ABBOTI LABORATORIES' PROPOSED ) SITE-SPECIFIC AMENDMENT TO ) APPLICABILITY SECTION OF ORGANIC ) MATERIALEMISSION STANDARDS AND ) LIMITATIONS FORTHE CHICAGO AREA;) SUBPARTT: PHARMACEUTICAL ) MANUFACTURING

## (35 ILL. ADM. CODE ) 218.480(b» ) R08-8 (Rulemaking -Air)



### NOTICE OFFILING TO: Mr. 

## John Therriault AssistantClerkofthe Board Illinois Pollution Control Board 100West Randolph Street Suite 11-500 Chicago, Illinois 60601 

### (VIA ELECTRONIC MAIL) Kathleen

## M. Crowley Hearing Officer Illinois Pollution Control Board 100 West Randolph Street Suite 11-500 Chicago, Illinois 60601 

### (VIAU.S. MAIL) (PERSONS ON ATTACHED SERVICE LIST) PLEASETAKE NOTICE that 

### I havetoday filed with the Office ofthe Clerkof the Illinois Pollution Control Board

### ENTRY OF APPEARANCE OFLAUREN C. 

### LURKINS, PREFILED TESTIMONY OF DIANE BENO IN SUPPORT OF PROPOSED SITE-SPECIFIC AMENDMENT, and

### PREFILED TESTIMONY OF ROBERT C. WELLS IN SUPPORT OF PROPOSED SITE-SPECIFIC AMENDMENT, copies ofwhich are herewith served upon you. Respectfully submitted, By: /s/ Katherine 

## D. Hodge Katherine

### D. Hodge Dated: February 22, 2008 Katherine D. Hodge Lauren C. Lurkins HODGE DWYERZEMAN 3150 Roland Avenue PostOffice Box 5776 Springfield, Illinois 62705-5776 (217) 523·4900

### Electronic Filing • Received, Clerk"s Office, February 22, 2008



## CERTIFICATEOF SERVICE I, Katherine D. Hodge, theundersigned, hereby certifY that Ihave servedthe ENTRY OFAPPEARANCE OF LAUREN C. LURKINS, PREFILED TESTIMONY OF DIANE BENO IN SUPPORT OF PROPOSED SITE-SPECIFIC AMENDMENT, and PREFILED TESTIMONY OF ROBERT C. WELLS IN SUPPORT OFPROPOSED SITE-SPECIFIC AMENDMENTupon: 

## Mr. John Therriault AssistantClerkofthe Board Illinois Pollution Control Board 100 WestRandolph Street Suite 11-500 Chicago, ILlinois 60601 viaelectronic mail onFebruary 22,2008; andupon: Kathleen M. 

### Crowley Hearing Officer Illinois Pollution Control Board James R. 

### Thompson Center 100 WestRandolph Street, Suite 11-500 Chicago, I1linois 60601 Charles E. Matoesian, Esq. 

### Assistant Counsel DivisionofLegal Counsel Illinois Environmental ProtectionAgency 1021 North Grand Avenue East PostOfficeBox 19276 Springfield, Illinois 62794-9276 Matthew J. 

## Dunn, Chief Environmental BureauNorth Office ofthe Attorney General 69 

### WestWashington Street, Suite 1800 

### Chicago, Illinois 60602

OfficeofLegal Services Illinois DepartmentofNaturalResources One Natural Resources Way Springfield, Illinois 62702-1271

by depositing said documentin the United States Mail, postage prepaid, in Springfield, Illinois onFebruary 22,2008. 

## lsIKatherine D. Hodge Katherine D. Hodge ABOT:003/FilingsINOF. PreFiledTestimony

### Electronic Filing· Received, Clerk"s Office, February 22, 2008



## BEFORETHE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTEROF: ) ) 

## ABBOTT LABORATORIES' PROPOSED ) SITE-SPECIFIC Alv.ffiNDMENT TO ) APPLICABILITY SECTIONOF ORGANIC ) MATERIALEMISSION STANDARDS AND) 

## LIMITA nONS FORTHE CHICAGO 

## AREA;) SUBPARTT: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b» ) R08-8 (Rulemaking -Air)

ENTRY OF APPEARANCE OFLAUREN C. LURKINS 

## NOWCOMES Lamen C. Lurkins. ofthelaw finn HODGE DWYERZEMAN, and hereby enters her appearanceinthis matteron behalfofAbbottLaboratories. Respectfully submitted,**By::~~l{LU---.!~~~** 

## Lauren C. Lurkins Dated: February 22. 2008 Lauren C. Lurkins HODGEDWYERZEMAN 3150 RolandAvenue PostOffice Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003/FiIIEOA

- LCL

### Electronic Filing· Received, Clerk's Office, February 22, 2008



## BEFORETHE ILLINOIS POLLUTION CONTROLBOARD INTHE MATIEROF: ) ) 

## ABBOTTLABORATORIES' PROPOSED ) SITE-SPECIFIC AMENDMENTTO ) APPLICABILITY SECTION OF ORGANIC ) MATERIAL EMISSION STANDARDS AND) LIMITATIONS FORTHE CHICAGO AREA;) SUBPARTT: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b» ) R08-8 (Rulemaking-Air)



### PRE-FILED TESTIMONY OFDIANE BENO, IN SUPPORT OF PROPOSED SITE-SPECIFIC AMENDMENT 

## NOW COMES ABBOTTLABORATORIES, by

## andthroughits attorneys, HODGE DWYERZEMAN, andpursuantto 35 Ill. Admin. Code § 

## 102.424 andthe Hearing OfficerOrder. datedJanuary 31, 2008, submits the following Pre-Filed Testimony ofDiane BenD forpresentationatthe March 7, 2008 hearing scheduledinthe above-referenced matter: TESTIMONY OFDIANE BENO 

## Myname is Diane Beno. Iamtheplantmanagerofthe portionofthe Abbott Laboratories facility internallyknown as Building AP16. 

## The operations containedin Building AP16 produce intermediateand final pharmaceuticalproductformulations, including liquids, tablets and capsulespackagedinbottles andblisterformats. The generalprocess flow involves: receipt ofrawmaterials; weighing ofingredients; massing andgranulationofingredients; compressing granulatedproduct into tablets; coating tablets orparticles; printing symbols onto tablets; andpackaging finished products for distribution.

### Electronic Filing. Received, Clerk's Office, February 22, 2008

Overthe course ofayear, we produce many differentproducts inBuilding AP16. For example, we produce pharmaceuticals that treat diseases in the field ofneuroscience such as epilepsy and bipolardisorder, we make antiviral products for the treatmentof AIDS, we manufacture antibiotics to fight infection, we packageproducts that help patients achieve healthy cholesterol levels, and products that improvethe lives ofpeople with rheumatoid arthritis, psoriasis and Crolm's disease. We manufacture ourproducts using batchproductionprocesses. In batch production, all ofthe processing equipment in a process train, including the dryers, manufactures one productat atime. Each batch is completedbefore the manufacture of the nextbatchbegins. In atypical process, the active and inactive ingredients are combined with a liquidin aprocess called '"massing!' This massing process forms uniform granules. The wetgranules are dried in tUlUlel dryers or fluid bed dryers and then furtherprocessed into tablets orcapsules. The massing fluid, which is typically either water or ethanol, is evaporated from the solidmaterial in the drying step. Ifan organic solventis volatilized from the dryer, it is emitted to the ambient air as volatile organic material ('"VOM") or volatile organic compounds C"VOCs"). The quantity ofYOM emissions

## will vary for differentproducts, and is calculated from the quantity ofVOM added to the mixture and loss factors defined for thedryers and specified in the CleanAirActPermitting Program ("CAAPP") Permit for the facility. It is also importantto note thatthe organic solvent currently used in granulation and dried from the granulated mixtures atBuilding AP16 is ethanol. Ethanol is a YOM, butis notconsidered a hazardous airpollutant ("HAP"). The proposed sitespecific amendmentwill have no effectonHAP emissions. 

## 2

### Electronic Filing. Received, Clerk's Office, February 22, 2008

Abbott's proposed**site~specific** 

### amendmentfor Building AP16 covers fourtunnel dryers andthree fluid bed dryers. One additional fluid bed dryer. located in Building AP16, is used exclusively for research and developmentoperations and is notinvolved 

### in the normal operating processes in Building AP16. Therefore, ourproposed amendment does notinclude that dryer. The tunnel dryers and fluid bed dryers operate on differentprinciples. Inthe use oftunnel dryers, materials to be dried are spread on trays and placed in a wanning chamberor "tunnel" thatcirculates warm air over andunderthe trays. A fluid bed dryeris a large vertical cylindrical shapedvessel with a diffuserthat blows warm airup from the bottom ofthe vessel. The wet intermediate granules are loadedinto the dryer and flow upward, suspended inthe warm air stream. Abbotthas increasedits use offluid bed dryers forrecently developed products because they are

more efficientand produce a more uniformproduct than the tunnel dryers. Abbott anticipates increased use ofwater for themassing fluid in future products. Abbott expects thatthis preferentialuse offluid bed dryers andwater-basedproducts 

## will continue. That is, many newproducts are expectedto use fluid bed dryers and waterbasedformulations. while olderproducts will continue to be manufacturedusing tunnel dryers. Batches ofspecific products are typically manufacturedusing eitherone ormore tunnel dryers. orone ormore fluid bed dryers. but notboth, because the technologies are not interchangeable. Individual dryers ofthe same type cantypically be used in combination or interchangeably in many cases, but specific dryers are preferable for



### 3

### Electronic Filing. Received, Clerk's Office, February 22, 2008

combiningwith otherequipmentin aprocess trainto manufacture certainproducts from

an operational efficiency standpoint. Abbott manufactures its products using batchprocesses whereby each manufacturing process train and its associated equipment (including the dryers) produces

one product at a time in fixed batch sizes. Processtrains are designed to accommodate batches ofdifferent scales, with some for large batches and others for small batches. Therefore, the scale ofa givenbatchplays an importantrole in detennining whichofthe dryers will he mostefficient. Additionally, in accordance with United States Foodand Drug Administration ("US FDA") currentGood Manufacturing Practice ("cGMP") guidelines, extensive equipmentcleaning is requiredbetween batches ofdifferent products, resulting inup to three days oflostproductiontime. Therefore, Abbottuses a campaign strategy to continue running batches ofthe same product consecutively in the process train to minimize this cleaningtime. As currently written, Section218.480(b) effectively defines a 12·monthtotal YOM limiton each individual dryer. This can limitAbbott's ability to schedulethe campaigns ofcertainproducts to maximize the efficiency oftheprocesses. In other words. to ensure compliance with the currentrunning 12-monthtotal YOM limiton each dryer, for aparticularbatch, Abbottmay be required to utilize a dryer with lowYOM emissions during the last 12 months instead ofusing the dryerthat is the mostefficient from aproduction-scale standpoint. Such selection ofdryers, based only on the amount ofVOM thathas been emittedfrom an individual dryer during the preceding 12months. is an inefficient approachto scheduling the use ofAbbott's equipmentand resources. Additionally, the dryer selectedfor a given campaign also depends on dryer availability 4

### Electronic Filing • Received, Clerk's Office, February 22, 2008



### andotherfactors. Forexample, onedryermay be 

### temporarily outofuseto allowfor cleaning orfor unscheduledmaintenancerequirements. Therefore. the standards, as currentlydefined, canresultinwastedresources byrequiring Abbottto dry asmall batch ofproductin ourlarge-scaleprocess train to maintain ourequipment-specific YOM limits. Total alUmal emissions from a dryerresultfrom the quantity oforganic solvent removed from the differentproducts processedin adryer overarolling 12-monthperiod. The material is processed in anumberofindividual campaigns for particularproducts, each consisting ofmultiple individual batches. The assignmentofacampaign ofa particularproductto one ormore dryers involves anumberofoperating factors, suchas scale andequipment availability. thatcontributeto the efficiency ofmanufacturing. The YOM emissionthreshold effectively acts as an overriding factorthatcan force a particularproduction campaignwith YOM emissions to be scheduledusing equipment thathas low enoughrecent emissions to avoid exceeding a dryerthreshold, butthatmay nototherwisebethe optimal ormostefficientequipment forthe campaign. This scheduling shift increases the operational cost, butresults inno environmental benefit, becausethe actual emissions willbethe same as ifthe campaignwouldhave usedthe optimal equipment. Inorderto ensureAbbott's Lake Countymanufacturing facilities remain competitive with ournational andglobal competitors, Abbottmustcontinually seekways ofmaking ourmanufacturing operations more efficient. The scheduling inefficiency createdby SubpartT was identified as one area where improvements in efficiency could be made and is the basis fortheproposedamendment. This seems particularly 5

### Electronic Filing· Received, Clerk"s Office, February 22, 2008 

### appropriate, as the business costcreatedbythis inefficiency results in no enviromnental benefit.Themostefficientmethodto manufacture Abbott's products inBuildingAP16 wouldbe to use the dryerthatis bestsuitedto the requirements oftheproduction schedule and scale, regardless ofthe amountofVOM thathas beenemittedfrom that dryerinthe past 12 months. Providedthatthe combined YOM emissions fromall ofthe dryers are less 

## thanthe combinedamount allowedunder Section218.480(b), this method ofoperationwould notrequire an 

### increase in allowable YOM emissions from the 

## Facility. Infact, theproposedamendmentwould provide Abbott improvedproduction flexibility to utilizethe mostefficientdryers for 

## a givenproduct, while significantly lowering the total allowed YOM emissions from all the dryers combined. Thankyou. I'll be happy to answerany questions.



# * ole ole 

### Abbottreserves the rightto 

### supplementormodify this pre-filedtestimony. Respectfully submitted, ABBOTT LABORATORIES, By:/s/Katherine 

## D. Hodae Oneofits Attorneys Dated: February22, 2008 Katherine

## D. Hodge Lauren C. 

### Lurkins 

## HODGE DWYERZEMAN 3150 Roland Avenue PostOfficeBox 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003/FilingsIBeno PrefiledTesLimony

- Final Draft 

### 6

### Electronic Filing· Received, Clerk"s Office, February 22, 2008

BEFORETHE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: ) ) 

### ABBOTT LABORATORIES' PROPOSED ) SITE-SPECIFIC AMENDMENT TO ) APPLICABILITY SECTION OF ORGANIC ) 

### MATERIALEMISSION STANDARDS AND) LIMITA

## nONS FORTHE CHICAGO AREA;) SUBPARTT: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b» ) R08-8 (Rulemaking -Air)



## PRE-FILED TESTIMONY OF ROBERT C. WELLS, IN SUPPORT OF PROPOSED SITE-SPECIFIC AMENDMENT NOW COMES ABBOTT LABORATORIES, by and through its attorneys, HODGE DWYERZEMAN, andpursuantto 35 Ill. Admin. Code 

## § 102.424 and the Hearing OfficerOrder, datedJanuary 31,2008, submits the following Pre-Filed Testimony ofRobert C. Wells for presentation at the March 7, 2008 hearing scheduled in the above-referenced matter: 

## TESTIMONY OFROBERT C. WELLS My name is Robert C. Wells. I am employedby AbbottLaboratories as Air Manager for Environmental Supportin Abbott's Global Environmental Health and Safety Department. I provide assistance to Abbottfacilities such as Building AP16 withregard to environmental compliance and managing environmental performance at our facilities undervarious airregulations. Ihave twenty-nine years ofexperiencein airquality managementand the analysis ofairemissions, emission control and ambient airquality. Ihold a BachelorofScience degree inEngineering from Cornell University. My testimony today concerns technical aspects ofAbbott's proposal for asitespecific amendmentto Illinois air regulations at 35 Ill. Admin. Code Part218.480(b), in

### Electronic Filing • Received, Clerk's Office, February 22, 2008

SubpartT ofPart 218. Abbott's proposed site-specific amendment concerns provisions impacting the four (4) tunnel dryers (also referred to as warm airdryers) andthree (3) fluid bed dryers located in Building AP16 atthe Abbott Parkfacility. The dryers are usedto dry mixtures ofactive pharmaceutical ingredients ("APls"), excipientingredients, and massing fluid afterthey have beenprocessedto produce a solid material withan appropriate granule size. The granulatedmixture is then used to manufacture dosage form products (i.e., tablets, capsules, and granules). The tunnel dryers and fluid bed dryers are currently subjectto airregulations for Volatile Organic Material ("VOM") emissions under 35 Ill. Admin. Code Part218, SubpartT. Underthis standard, an individual dryeris required to control YOM emissions ifits annual emissions exceed7.5 tons peryear (ton/yr) for a tunnel dryer or5 ton/yrfor a fluid bed dryer. Emissions from anyone dryer vary from yearto year. Historically, emissions from each dryerhave been significantly belowthe level that would triggerthe requirement for add·on control. Emissions from individual dryers have beenheld below these limits inpartbyplanning productionto distribute VOM.emitting production among the different equipment. Because ofthe variability, and because ofthe significantcost to install and operate controls for a dryerthatwould notbejustified, these control thresholds effectively act as the upperlimitfor annual YOM emissions from an individual dryer. At this time, production scheduling canbe forced to assign one ormoredryers to

aproduction campaign based onthe dryers' recentpastYOM emissions, assigning one or

more dryers thathave low enough recentemissions to avoid exceeding a dryerthreshold, 

### 2

### Electronic Filing. Received, Clerk"s Office, February 22, 2008

butthatmay not otherwise be the optimal or mostefficient equipment forthe campaign. This scheduling shift increases the operational cost, butresults in no environmental benefit, because the actual emissions will be the same as ifthe campaign wouldhave used the optimal equipment. This scheduling inefficiency was identified as one area where improvements in efficiency couldbe made, while notincreasing the environmental impact ofAbbott's operations. Two environmental management approaches were identified and considered 

### in orderto alleviate the inefficiency ofthe SubpartT operating constraints. One alternative wouldbe to increase the thresholdthat would triggerthe emission control requirementfor

one or more individual dryers. Suchan increasewould bejustified ifthe costofcontrol is greater than what is considered economically achievable for Reasonably Available Control Technology ("RACY'), which was thejustificationforestablishing the original thresholds in SubpartT. Apreliminaryreview ofemission control costs indicatedthat RACT controls would notbejustifiedeven at emissionthresholds significantly higher than the current limits specified in SubpartT. A second alternative would be to treatthe currentcontrol threshold as a combined threshold equal to the sum ofthe individual unit thresholds for the seven manufacturing dryers. This approach would remove a manufacturing constraint without increasing the allowable YOM emissions fromthe facility.The above alternatives were first evaluatedinternally within Abbott. Under the first approach, while Abbottbelieves that 

### it would bejustifiableto increase the emission threshold for one ormore dryers, itwould also actto increase the facility's allowable emissions, which is not necessaryto solve problems ofmanufacturing efficiency. The 

## 3

### Electronic Filing. Received, Clerk"s Office, February 22, 2008

second approach, to re-definethe emissionthreshold as a combinedthreshold for all dryers, wouldremedy manufacturing inefficiencies without increasing overall allowable 

## YOM emissions. Both ofthese approaches were discussed

### with the Illinois Environmental Protection Agency ("Illinois EPA"). At thattime, Illinois EPA indicatedthat both Illinois EPA policy and United States Environmental ProtectionAgency C"USEPA") regulations and guidelines would need to be considered in order for the agencyto support

a site-specific amendmentto 35 Ill. Admin. Code Part 218. Subsequentdiscussions among Illinois EPA, USEPA, and Abbott's representatives identified an existing USEPA programthat wouldprovide similar operational benefits as the combinedthreshold approach discussed above. USEPA's Economic Incentive Programs ("EIPs") are described inUSEPA's document, Improving Air Qualify With Economic Incentive Programs, EPA-452/R-OI-00l, January 2001, whichwas provided as Exhibit 2 to the StatementofReasons for the proposed sitespecific amendment. Among otherprograms, this guidance includes provisions for a Source-Specific Emission Cap ("SSEC") as an altemativeregulatory approach for emission limits that can regulate emissions with greaterflexibility and efficiency than conventional approaches. Discussions with Illinois EPA and USEPA indicated that a SSEC couldallow individual emissionlimits to be combinedinto anaggregate cap for the tunnel dryers and fluid bed dryers, providedthatthe SSEC is setto a level which is less than the units' combinedhistorical actual emissions, ratherthan equal to currentcombined allowable emissions. Both Illinois EPA and USEPA indicatedthat a SSEC ElP would be an 

## 4

### Electronic Filing • Received, Clerk's Office, February 22, 2008

acceptable methodto address the applicabilityprovisions ofSection 218.480(b) with respectto Abbott's tunnel dryers and fluidized bed dryers. Underthe currentregulatory standard, the combined allowable emissionthreshold for Abbott's dryers is 45 ton/yr ofVOM emissions. This is based on the sum ofthe allowable emissions for fourtunnel dryers at7.5 tonlyreach and three fluid beddryers at 5.0 ton/yreach. A SSEC withinthe EIPs would typically require allowable emissions to be reduced below abaseline level defined by the historical actual emissions for the units. UnderUSEPA guidelines, historical actual emissions are defined as the highest actual emissions from any 2-yearperiod within the last 10 years ofoperation. In addition, the EIP requires a demonstration ofenvironmentalbenefit, which canbe achieved by setting

an emission limit 10 percentbelow the baseline emissions. Such a program would 

### be

more constraining than eitherofthe two alternatives proposed by Abbott. However, while eitherofAbbott's original alternatives would likely be approvable, itwas recognized that itwould be more administratively efficientto work within the EIPs framework ifitwere otherwise acceptable to achieve Abbott's goals. Abbottreviewed its historical actual emissions to determine ifa SSEC would 

### be appropriate. Actual emissions from the sevendryers are shownin Exhibit3 ofthe StatementofReasons for this site-specific amendment. In accordance withUSEPA guidance, the baseline emissions for BuildingAP16 were calculated to be 22.9 ton/yr based on thehistorical actual emissions from the highest 2-yearperiod ofthe past 10 years. Thus, in orderto demonstrate environmental benefitas described in the ElP guidance, the total allowable combined emissions from the seven dryers underthe

5

### Electronic Filing • Received, Clerk's Office, February 22, 2008 

## proposed SSEC would need to be setat alevel 10percentlowerthan the calculated baselineemissions, or20.6tonlyrofVOM. In comparisonwith this prospectivelimit, the currentcombined allowableYOM emissionrate, basedonthe individualthresholds for eachofthe sevendryers, is45 tonlyr. Although Abbottcould operate atthis emission level ifneeded foroperations, its historical actual emissions have consistentlybeenlowerthanthe currentcombined allowable emissions forthe sevendryers. Thus, thecurrentallowable combinedemission rateis higherthanwhatAbbottis proposingunderthe amended**site~specific** 

## standard. Abbottconsiders theflexibility to shiftproductionamong the dryers to be moreimportant thanthe ability to operate withcurrentmaximum overall emissions. Therefore, the principalrequirementfor a SSECundertheEIP, acombined allowable emission threshold lowerthanhistorical actualemissions, wouldbean acceptable alternative to Abbott.In orderto ensure thatthe proposed site-specific amendmentto 35 Ill. Admin. Code §218,480(b) is consistentwith USEPA guidance regarding EIPs, and torealizethe administrativebenefitofaprogramthatis acceptable to 

## all prospectiveparties, the program must satisfythree fundamental principles of USEPA's EIPprogram: integrity, equityand environmental benefit. These are definedand discussedinUSEPA's 

## ImprovingAirQualitywith EconomicIncentive Program. See Exhibit2, Statementof Reasons. Consistencywith eachofthese threeprinciples is discussed separatelybelow. Theprinciple ofintegrityconsists offourelements: emissions must be 

## surplus, quantifiable. enforceable, andpermanent. Notethatthese terms have specificmeanings, and aredifferentfor a SSEC thanforotherprograms addressedbythepolicy. 

# I4.. at 35. 6

### Electronic Filing· Received, Clerk"s Office, February 22, 2008

• Emissions are surplus because the baseline for the prospective SSEC for the seven dryers is based onthe historical actual emissions forthese units, andbecause the program will reduce emissions belowthis baseline.

• Emissions are quantifiable becausethe calculation ofbothbaseline emissions and future emissions underthe SSEC is based on a mass balance for a solvent evaporationprocess with YOM among the materials used. A mass-balance calculation is consideredto be a very reliable methodology for quantifying YOM emissions on a 12-month average basis. The methodology for quantifying emissions from the dryers is alreadywell documented in the facility's CAAPP Pennit.

• Emissions are enforceable because the program is to be incorporated into 35 Ill. Admin. Code Part 218, approved byUSEPA as partofIllinois' State Implementation Plan for ozone attainment, and incorporatedinto the facility's CAAPP Permitas an applicable requirement. Enforcement will be based onthe sameprogramthatis now in place in the CAAPPPermit, where emissions are tracked by mass-balance emission calculations based onproductionrecords.

• Emissions are permanentbecause the site-specific amendmentto 35 Ill. Admin. Code Part218 will memorialize the conditions. The principle ofequity is evaluatedto ensure thatthe EIPs programdoes not result in "an uneven distribution ofemissions or ... effects," 

## I4.. at46. This programis not ofconcern for equity issues forthree reasons.

• This program focuses exclusively on YOM emissions from one particular facility. Therefore, there is no concern for impacts in one areathatmust bebalancedequitably withreductions in anotherarea. In addition, the EIP will result in loweremissions than the historic actual emissions forthe units inthe sole area ofimpact. Therefore, there will be no areaof increased environmental impactthat mustbe balanced against anoverall impactreduction. 

### In concWTence, USEPA guidance indicates that equity issues are typically notofconcern for a single-site SSEC program. Id. at 50.

• Emissions ofYOM have environmental effects on aregional scalerather than a localizedimpact. Also, the overall impact ofthe program

## will be positive because both allowable and historical actual emissions 

## will be reduced. The principle ofenvironmentalbenefitis satisfied by the intentionforthe programto reduce emissions 10percentbelowhistorical actual levels. While other 

## 7

### Electronic Filing • Received, Clerk"s Office, February 22, 2008



## demonstrations ofbenefits may be appropriate, the 10percentemissionreductioncriteria is clearly definedby USEPA as appropriatefordemonstration ofenvironmentalbenefit. Id. at 51. Illinois EPA and USEPAboth agreedthatAbbott's proposal metthe criteriafor

a 

## SSEC 

## EIP. In swnmary, the proposed site"specific amendment

## willresult in significant environmentalbenefits. Maximum future 

## allowable emissions of20.6tonlyrfromthe

sevendryers will be 10percentbelowthehistorical 

## actualemissions determinedby USEPA criteria(22.9 ton/yr). Future actual combinedemissions from the sevendryers 

## will bewell below whatis currently allowedfor the units (45 ton/yr). Atthe sametime, theproposed site-specific amendmentwill provideincreased operationalefficiency and flexibilitythatwillbevaluableto Abbottin addressing our national and global competitors. As importantly to the overall result, Abbott's increased flexibility canbe achieved withoutrelaxingthe stringency ofthe currentemission control thresholds. Iwould liketo thankthe Board for itstime and attention inconsideringour proposal and my testimony. Iwouldalso like to thankthe Illinois EPA forworking 

## with Abbottto identify apractical site-specific amendmentfor greaterregulatory efficiency. I wouldbe happyto answer any questions.



# *

8 

# *

### Electronic Filing· Received, Clerk's Office, February 22, 2008



## Abbottreserves therightto supplementormodifythis pre-filedtestimony. Respectfully submitted, ABBOTTLABORATORIES,

By:/s/KatherineD. Hodge Oneofits Attorneys Dated: February22, 2008 Katherine D. Hodge Lauren C. Lurkins 

## HODGE DWYERZEMAN 3150 Roland Avenue PostOfficeBox 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003/FilingsfWells Prefiled Testimony

- Final Draft



### 9**R08~8** 

## (Rulemaking

- Air) IEPAATTACHMENTNO.

# L Electronic filing· Received, Clerk's Office, February 29, 2008



## BEFORETHE ILLINOIS POLLUTION CONTROL BOARD 

## INTHEMATTER OF: ) ) 

## ABBOTTLABORATORIES' PROPOSED ) SITE-SPECIFIC AMENDMENTTO ) APPLICABILITY SECTION OFORGANIC ) MATERIALEMISSION STANDARDS AND ) LIMITATIONS FORTHE CHICAGO AREA; ) SUBPARTT: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b» ) NOTICE OF FILING TO: Mr. JohnTherriault KathleenM. Crowley Assistant Clerkofthe Board Hearing Officer Illinois PollutionControl Board Illinois PollutionControl Board 100WestRandolph Street 100WestRandolph Street Suite 11-500 Suite 11-500 Chicago, TIlinois 60601 Chicago, Illinois 60601 (VIAELECTRONIC MAIL) (VIAU.S. MAIL) (PERSONS ONATTACHED SERVICELIST) PLEASE TAKENOTICEthatIhavetoday filed withthe Office ofthe Clerkof the Illinois PollutionControlBoardABBOTT LADORATORIES' MOTIONTO FILEREVISED EXmBIT3 AND MINORREVISION TO PROPOSED SUBSECTION218.480(b)(4), acopyofwhichis herewith served uponyou. Respectfully submitted, By: lsi KatherineD. Hodge KatherineD. Hodge Dated: February 29, 2008 Katherine D. Hodge Lauren C. Lurkins 

## HODGEDWYERZEMAN 3150 RolandAvenue PostOffice Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900

THIS FILING SUBMITTED ON RECYCLED PAPER

### Electronic filing • Received, Clerk's Office, February 29, 2008



### CERTIFICATEOF SERVICE I, Katherine D. Hodge, the undersigned, hereby certify that I have served 

### ABBOTT LABORATORIES' MOTIONTO FILE REVISED EXHIBIT 3AND 

### MINORREVISION TO PROPOSED SUBSECTION 218.480(b)(4) upon: Mr. John Therriault Assistant Clerk ofthe Board Illinois Pollution Control Board 100 West Randolph Street Suite 11-500 Chicago. Illinois 60601 via electronic mail on February 29, 2008; and upon: Kathleen M. Crowley Hearing Officer Illinois Pollution Control Board James R. Thompson Center 100 WestRandolph Street, Suite 11-500 Chicago, Illinois 60601 Charles E. Matoesian. Esq. Assistant Counsel Division ofLegal Counsel Illinois Environmental Protection Agency 1021 North Grand Avenue East Post Office Box 19276 Springfield, Illinois 62794-9276 Matthew

### J. Dunn, Chief Environmental BureauNorth Office ofthe Attorney General 69 West Washington Street, Suite 1800 Chicago, Illinois 60602

Office ofLegal Services Illinois DepartmentofNatural Resources One Natural Resources Way Springfield, Illinois 62702-1271

by depositing said documentin the United States Mail, postage prepaid, in Springfield, Illinois on February 29,2008. 

# lsi Katherine D. Hodge Katherine D. Hodge ABOT:003/FilingsINOF. ExhibitJ

### Electronic filing· Received, Clerk's Office, February 29, 2008

BEFORE THEILLINOIS POLLUTION CONTROL BOARD

IN THEMATTER OF ) ) ABBOIT LABORATORIES' PROPOSED ) SITE-SPECIFIC AMENDMENT TO ) APPLICABILITY SECTION OF ORGANIC ) MATERIALEMISSION STANDARDS AND ) LIMITAnONS FORTHE CHICAGO AREA; ) SUBPARTT: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b» ) R08-8 (Rulemaking

- Air)



### ABBOTTLADORATORIES' MOTIONTO FILEREVISED EXHIBIT 3 AND MINORREVISION TO PROPOSED SUBSECTION 

## 218.480Cb)(4) NOW COMES ABBOTT LABORATORIES ("Abbott''), by andthrough its attorneys, HODGE DWYERZEMAN, andhereby requests the Illinois Pollution Control Board ("Board") to accept for filing Abbott's RevisedExhibit 3 and Minor Revisionto proposed 35 Ill. Admin. Code Subsection 218.480(b)(4). In supportofthis Motion, Abbott states as follows: 

### 1. Abbottfiled its original Proposal ofAmendments to 35 

## Ill. Admin. Code Part218.480(b) ("Original Proposal ofAmendments") with the Boardon September4, 

## 2007. 2. Abbott's Original Proposal ofAmendments included: 1) the Proposed Amendments; 2) the StatementofReasons; 3) Appearances for the attorneys representing Abbott; 4) aMotion to Waive Requirementto Submit200 Signatures; 5) aMotion for ExpeditedReview; 6) Exhibit 1, Aerial Photograph ofAbbottParkand Vicinity, LibertyvilleTownship, Illinois; 7) Exhibit2, ImprovingAir Quality withEconomic Incentive**Programs~** 

### United States Environmental ProtectionAgency, January 2001; and

### Electronic filing. Received, Clerk"s Office, February 29, 2008



## 8) Exhibit3, atableentitled "HistoricalYOMAirEmissions from Tunnel Dryers and FluidBedDryers atthe AbbottParkFacility." 3. Since filing its OriginalProposal ofAmendments, Abbotthas discovered that severalrevisions and clarifications werenecessaryto Exhibit 3, thetableentitled "Historical YOM Air Emissions from Tunnel Dryers andFluid BedDryers attheAbbott ParkFacility." 4. Therefore, Abbottseeks to file RevisedExhibit3 withtheBoardthat includes the following changes: 1) correctatypographical errorforthe 1999 total, changing 26.1 to 25.1; 2) show single-unitdataat2 decimalplaces; 3) add aline for 90% ofthe baseline, withthe correctedvalue 0[20.6 tons peryear; 4) addNote cto identify the round-offissue andspecify thattotals are correctbased oncalculations withmore significantfigures; and 5) updatethe referenceinNote ato reflectthe correctconditionin the renewed CAAPP Permit, issued on September26, 2007. 5. Inaddition, Abbott also seeks to file aminorrevisionto Proposed Section 218,480(b)(4) toreflectthechange madeto the 90% baseline calculation, as follows: 

# 11 Forfluidbed dryers #1. #2. and#3 andfortunnel duers #1. #2. #3 and#4. the combinedtotal annual emissions from the dryers listed inthis subsection218.480(b)(4) shall notexceed 18,779 18,688 kg/year (;;Q.,.7

## 20.6 tons/year). [BOARD NOTE: tunnel dr.yers are otherwisereferredto as warmairdryers]; and



# ... ... *

2

### Electronic filing • Received, Clerk"s Office, February 29, 2008



## WHEREFORE, forthe above andforegoing reasons, ABBOTT LABORATORIES hereby respectfully requests theIllinois Pollution Control Boardto acceptfor filing ABBOTTLABORATORIES' RevisedExhibit 3 and MinorRevisionto Proposed Subsection218.480(b)(4). Respectfully submitted, ABBOTTLABORATORlliS By: Is/Katherine 

## D. Hodge One ofIts Attorneys Date: February29, 2008 Katherine 

## D. Hodge LaurenC. 

## Lurkins HODGEDWYERZEMAN 3150RolandAvenue PostOfficeBox 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003/FilingsINOFMotion to file Revised Exhibit3 lIIId Amended Proposal



### 3

### Electronic filing • Received, Clerk"s Office, February 29, 2008

Revised Exhibit 3 (2/29/08) Historical YOM Air Emissions from Tunnel Dryers and Fluid Bed Dryers at the Abbott Park Facility a 

### (tons peryear) C

Total Total Total Fluid Fluid Fluid Tunnel Fluid Bed Dryer Tunnel Tunnel Tunnel Tunnel Bed Bed Bed Dryer Dryer VOM Year Dryer 1 Dryer2 Dryer3 Dryer4 Dryer 1 Dryer 2 Dryer 3 Emissions Emissions Emissions 1998 2.65 2.19 2.59 3.27 1.34 1.12 b 10.7 2.5 13.2 1999 4.52 5.58 5.31 5.16 2.35 2.15 b 20.6 4.5 25.1 2000 3.79 4.01 3.15 3.30 3.16 3.16 0.17 14.2 6.5 20.7 2001 0.70 1.60 1.70 1.30 1.70 1.60 1.70 

### 5.3 5.0 10.3 2002 1.80 1.80 1.80 1.20 0.90 0.90 3.10 6.6 4.9 11.5 2003 2.40 2.10 2.20 1.20 1.00 1.00 2.90 7.9 4.9 12.8 2004 

### 3.40 1.70 1.50 0.60 0.00 0.00 3.90 7.2 

### 3.9 11.1 2005 2.10 1.50 1.20 0.00 0.10 0.10 3.00 4.8 3.2 8.0 2006 1.00 1.11 0.91 0.00 0.66 0.66 2.97 3.0 4.3 7.3 2007 1.71 0.69 1.03 0.00 0.41 0.41 3.19 3.4 4.0 7.5 Average of Years 1999 

### &2000 (baseline) 22.9 90 Percent of Baseline 20.6 

### Notes to Exhibit 3

a Emissions ofVOM were calculated based on records of production batches, corresponding VOM content ofthe batch, and specified loss factors forthe respective equipment, as detailed in 

### CAAPP Permit Section 7.1.12(e). b Fluid Bed Dryer 3 was not operating priorto 2000. c Some data were included in calculations to more precision than one decimal place. which can result in apparent discrepancies for total emissions. Total emissions are calculated with available precision and rounded to one decimal place.

### ILLINOIS POLLUTION CONTROL BOARD March 4, 2008 tEPAATTACHMENT NO.-1i

## RECEIVED

CLERK'S OFFICE



# MAR - 2008 STATE OF ILUNOIS 

## Pollution Control 

## Board IN THE MATTER OF: ) ) 

### ABBOTT LABORATORIES' 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» R08-8 (Rulemaking

- Air)



### HEARING OFFICERORDER On September4, 2007, Abbott Laboratories (Abbott) filed a proposal for site-specific rulemaking pursuant to Section 28 ofEnvironmental Protection Act (Act) (415 ILCS 5/28 (2006», to allow it "additional operational flexibility" with regard to emissions from certain tunnel dryers and fluid bed dryers at its pharmaceutical manufacturing facility (the Facility) located in Libertyville Township, Lake County. As explainedintheJanuary 31, 2008 hearing officerorder, the hearing in this rulemaking will beheld in Libertyville onMarch7, 2008, beginning at 1:00p.m. Both the technical justification and economic impact ofthe rules will be addressed atthis hearing; as the Board presently does notintendto schedule anotherhearing. 

### See Section 27 (b) ofthe Act, 415 ILCS 5/27(b) (2006) and Section 102.414 ofthe Board's procedural rules, 35 Ill. Adm. Code 102.414. On 

### February 22, 2008, consistentwith the hearing officerorder, Abbottprefiled testimony ofDiane Beno and Robert C. Wells. The Illinois Environmental Protection Agency (Agency) has notprefiled any testimony. No other testimony has been prefiled. In the interest offacilitating the hearing process, the Boardhas reduced to writing questions it would like the participants to address athearing, and is making them available to participants in advance ofhearing. These questions appear on pages 2-5 ofthis order. While some questions are addressed to particularwitnesses, any participant is free to address any ofthe questions. The hearing officerhas today telephoned counsel for Abbott and the Agency to advise them ofissuance ofthis order. The Board's Clerk's Office is placing this order on the Board's website today, and is advising counsel who have filed appearances ofits availability. This order will also be served on all parties on the notice list for this proceeding.

### 2 

### Questions on Proposal & 

### Pre-filed Testimony Statement ofReasons 1. Onpage 3, the Statement ofReasons (SOR) states thatthe current YOM requirements at Section 218.480(b) are based onthe provisions ofSection 215.480(b), which was adopted by the Board on April 7, 1988 in DocketR86-1 

### O. Further, the SOR states that during the rulemaking in R86-1 0 both the petitioner and IEPA "providedtechnical documentation and testimonyto the effectthat certain emission sources, includingtunnel dryers and fluid bed dryers, wouldbe economically infeasible to control at the levels required for certain otheremission sources at the facility." a) Please comment onwhetherthe information/testimonypresented in the R86- 10rulemaking regarding economic feasibility ofcontrolling emissions from Abbott's tunnel dryers and fluid bed dryers is still valid. b) Has there beenin any development in emissions control technology since the adoption ofthe original rules that addresses the economic concerns associated with control ofemissions from the affected dryers? 2. Onpage 6, the SOR notes thatthe average actual emissions from the fluid bed dryers and tunnel dryers for 1999 and 2000 were used to determine the proposed combined emission limit of20.7 tons peryear. (This was revised to 20.6 tons peryearin Abbott's February 29,2008 motion to amend.) According to Exhibit 3, total emissions from years 1999 and 2000 representthe highest actual emissions. Starting from 2001 and until 2007, the total actual emissions from the affected dryers are approximatelyhalfthe total emissions in 1999 and 2000. Further, the YOM emissions data show a declining trend. a) Please explainthe reasons for the significantly lower actual emissions from the dryers since year 2000. b) The amended Exhibit 3 indicates that tunnel dryer#4 has zero YOM emissions since 2005. Please explain whetherAbbotthas stopped operating dryer#4. 

### PrefiledTestimony

- Diane Beno I. Onpage 2, you state that the organic solvent currentlyused for massing fluid in AP-16 is ethanol. Please comment on whetherAbbotthas used organic solvents other than ethanol in the manufacture ofpharmaceuticals in the past. Ifso, pleaseprovide names ofother solvents used for massing fluid. 2. Please explainthe basis for choosing the type ofsolventused for massing fluid, i.e. whetherthe solvent type is mainlydependent on the productbeingmanufactured orthe type ofsolvent is also dependent on the type ofdryerbeing used in the process.

### 3 

### 3. On page 3, you state that Abbotthas increased the use offluid dryers for recently developedproducts, and anticipates increaseduse ofwater for the massing fluid.

a. Please comment on whetherAbbott anticipates increased use ofwaterin product lines usingbothtunnel dryers and fluid bed dryers. b. Is the anticipated increase in use ofwater for massing fluid intended to reduce YOM emissions? Ifso, have you made any estimates ofthe amount ofVOM reductions thatmayresult from increased use ofwater?

c. Please elaborate onwhy Abbot considers water-based products as a "preferential use", d. Please explain whatrole, ifany, pollutionprevention (PP) plays in increasing the use ofwater for massing fluid in future products. Does Abbotthave some type of an in-house PP incentive programto reduce YOM emissions? Please elaborate on Abbott's PP activities as theymay relate to the affected dryers. 4. Also on page 3, you note that increaseduse offluid dryers is mainly becausethey are more efficient andproduce amore unifotn1 product than tunnel dryers.

a. Please explain how the fluid bed dryers are more efficientthan the tunnel dryers. b. Does Abbott have any plans to replace the tunnel dryers with fluid dryers? 5. On page 4, you statethat underthe currentrules, Abbottmayberequired to utilize a dryerwith low YOM emissions during the last 12 months instead ofusing the dryerthat is most efficient from aproduction-scale standpoint to ensure compliance with the current running 12-monthtotal YOM limit on each dryer.

a. Please clarify what you meanby "usingthe dryerthatis most efficient from a production-scale standpoint." b. Otherthan a dryer's previous 12-month YOM emissions, what factors are considered in deciding the type ofdryer used for aparticularcampaign? Prefiled Testimony

- RobertWells 1. On 

### page 5, you state that underUSEPA guidelines, "historical actual emissions" are defined as the highest actual emissions from any 2-yearperiodwithin the last 10 years of operation. Please clarify :whetherthe definition of"historical actual emissions" used in yourtestimony is based onthe USEPA's Economic Incentive Program (EIP) guidelines. lfnot, pleaseprovide acomplete citation to the appropriateUSEPApublication, which defines what constitutes historical actual emissions.

### 4 

### 2. The USEPA's ElP guidelines atpage 166 defines "historical actual emissions" as "actual emissions associated with a source in atime period priorto the source's participation in EIP, usuallyrepresenting the average emissions ofthe past two years or some othermore representative period."

a. Please explain whythe baseline was not calculated on the basis ofaverage emissions ofthe past two years (2006 & 

### 2007). b. Ifthe basis forusing the average emissions from 1999 and 2000 is becausethat period is more representative, please explain whythat timeperiod is considered representative. Particularly, since the emissions dataindicate significantly lower emission during 2001 to 2005. 

### USEPA's Economic Incentive Program Guidance 1. Atpage 3, the EIP guidance states thatthe guidance applies ifa state ortribe wants to establish a discretionary EIP for attaining ormaintainingthe national ambient airquality standards (NAAQS) for criteriapollutants. Further, the guidance notes that any government agency with the authorityto administer a SIP orTIP may adopt a discretionary EIP.

a. Does the above statementimply thatthe state should first adopt some type ofa discretionary EIP policybefore considering arequest such as the one made by Abbott? b. If

### so, has the Agency adopted an EIPpolicy for Illinois? Ifnot, shouldthis rulemakingbe considered as the State's adoption ofthe EIP policy?

c. Please commentonwhether Abbott's proposal is the first requestmade underthe USEPA's EIP in Illinois. 2. Atpage 6, Mr. Wells states that in orderto ensure thatthe proposed site-specific amendment is consistent with USEPA EIP guidance, and to realize the administrative benefitofaprogram, the program must satisfythree fundamental principles ofUSEPA's EIPprogram: integrity, equity and environmental benefit. Does the Agencybelievethat the proposed rule along with the supporting documentation satisfies the EIP principles? 3. Atpage 6 ofMr. Wells' testimony, Mr. Wells states that the principle ofintegrity consists offour elements: emissions mustbe surplus. quantifiable, enforceable, and pennanent. Furtherhe notes thatthese tenns have specific meanings, and are different for a source specific emissions cap (SSEC) than for otherprograms addressedby the policy.

a. Please clarify whetherthe SSEC elements are those described under Section 4.1 (b) ofthe guidance at page 38.

### 5 b. Regarding emissions being surplus, is there any concern that the proposed combined YOM limit may not be consistent with the EIP guidance since the baseline is calculated on thebasis ofhighest actual emissions? 

### Proposed Amendments 1. Abbott's proposal amends the existingrules at 

### 35 Ill. Adm. Code 218.480(b), which sets forth that the YOM limits apply to air suspension dryers, fluid bed dryers, tunnel dryers, and Accelacotas located in Libertyville Township, Lake County, Illinois. Please comment on whetherthe rules should specifically state thatthe YOM limits apply to dryers located at the Abbott Laboratories, Building API6, especially since the proposed amendments at Section 218.480(b)(4) refer specificallyto certain numbered fluid bed dryers, and tunnel dryers. 

### Abbot's February 29, 2008 Motion to Amend This orderdoes not address Abbott's February 29,2008 motion to amend Exhibit 

### 3 as well as the text ofits proposal. This motion 

### is better addressed at hearing. Again, atthe close ofhearing, the hearing officerwill set a date bywhich the record will close and all public comments mustbe submitted. See 

### 35 Ill. Adm. Code 102.108. As the Board is aware that Abbottwould appreciateBoard decision making as soon as possible, the posthearing comment period will notbe lengthy unless unanticipated circumstances dictate otherwise. IT IS SO ORDERED.

Hearing Officer, Illinois Pollution Control Boar 100WestRandolph Street, Suite 11-500 Chicago, Illinois 60601 (312) 814-6929 crowlek@ipcb.state.il.us

### BEFORE THE ILLINOIS POLLUTION CONTROL BOARD 1 2 

### 3 IN THE MATTER OF: 4 5 

### ABBOTT LABORATORIES' 6 PROPOSED SITE-SPECIFIC 7 AMENDMENT TO APPLICABILITY 

### IEPAATTACHMENT

# No.l

1

8 9 

### SECTION OF ORGANIC MATERIAL EMISSION STANDARDS AND NO. R08-8 (Rulemaking-Air) 10 LIMITATIONS FOR THE CHICAGO 11 AREA; SUBPART T:PHARMACEUTICAL 12 MANUFACTURING (35 

### ILL.ADM.CODE 13 

### 218.480(b) 14 15 

### 16 REPORT OF PROCEEDINGS had before the 17 ILLINOIS POLLUTION CONTROL BOARD held on March 8, 18 2008, at 1:00 o'clock p.m. at the Libertyville 19 Village Hall, 118 Cook Road, Libertyville, Illinois. 20 21 22 23 

### 24

### 1 A P PEA RAN C E S: 2 

### MEMBERS PRESENT: 3 

### 4 ANAD RAO, CHAIRMAN THOMAS E. JOHNSON, MEMBER 5 NICHOLAS J. MELAS, MEMBER 6 

### 7 CHARLES MATOESIAN 8 Illinois Environmental Protection Agency 9 

### HODGE DWYER ZEMAN 10 BY: MS. KATHERINE D. HODGE 3150 Roland Avenue 

### 11 Post Office Box 

### 5776 Springfield, Illinois 

### 62705-5776 12 (217) 523-4900 13 On behalf of Abbott Laboratories; 

### 14 15 16 17 18 

### 19 20 21 22 

### 23 24 21 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MS. CROWLEY: Good afternoon. This is

a hearing being conducted by the Illinois Pollution Control Board in a matter of

our docket number R08-8 Abbott Laboratories proposed site specific amendment to applicability section of organic material emission standards and limitations for the Chicago, Subpart-T, Pharmaceutical manufacturing at 35 Illinois Administrative Code 218.408(b). The Board opened this docket October 4th to consider Abbott's proposal for site specific rulemaking. In addition to myself, present from the Board today are seated to my immediate right, Board member Nicholas J. Melas, who is the lead Board member for this rulemaking. Seated to my immediate left is Anad Rao, an environmental engineer on the board's technical staff, and seated to Mr. Rae's left is Board member Thomas E. Johnson. Board member Andrea Moore asked me to remind you that she is abstaining from any participation in the hearing or decision 31 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 making in this rulemaking as she owns a small amount of stock in Abbott and also has close family members who are employed by Abbott. Would you like to make any remarks at this point, Mr. Melas? MEMBER MELAS: Nothing else but to welcome you all here. It will be a pleasure listening to the answers to the pre-filed questions. MS. CROWLEY: Today we're holding the first and only hearing currently scheduled in this rule making. I see that there are no members of the public present so I will cut short the introductory remarks that we usually make a little bit. The proceeding is governed by the Board's procedural rules. All information that is relevant and not repetitious is admitted into the record. The Board makes its rulings on the basis of its sworn and transcribed records. So the hearing officer will be asked to swear in the witnesses. I also want to remind you that any questions that may be posed today by any member of the 41 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Board or staff are intended solely to develop

a complete and clear record for the Board and

are not intended to reflect any prejudgment of the proposal. The hearing today will consider both the technical justification of the proposal, as well as any economic impact of the proposed rules as required by Section 27-B of the Environmental Protection Act. On October 18, 2007 the Board requested The Department of Commerce and Economic Opportunity to conduct an economic impact study. That department has not responded to this request or pre-filed a study within the 45-day period the Act provides, so the Board will be basing its decision on the economic information that is provided today and in any post-hearing comments. The Board has received pre-filed testimony in this proceeding only from the two witnesses from Abbott. We also have some pre-filed questions that were developed by the Board and given to the parties on March 4, 2008. So we will begin, I think, by asking the 51 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 attorneys to introduce themselves and then we will turn the proceedings over to Ms. Hodge for Abbott. MS. HODGE: Thank you very much. Good afternoon, everyone. Thank you for allowing

us to come here today to present support for

our proposal. My name is Katherine Hodge, H-O-D-G-E, and I'm with the Hodge Dwyer Zeeman here today representing Abbott Laboratories. MR. MATOESIAN: Good afternoon. I'm Charlie Matoesian. I'm with the Illinois Environmental Protection agency. I'm hearing appearing for the agency, although we are not part of the filing per se. MS. HODGE: Also present with me today

on behalf of Abbott Labs is Mr. Steve Ziesmann, right here. He is the senior counsel for legal and regulatory compliance for Abbott. Diane Beno, to my immediate left. She is the manager of Abbott's operations in building AB16, some of which

are the topic for this proceeding. Mr. Bob Wells to her left, and Bob is the air manager 61 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 for environmental support in Abbott's global environmental health and safety department and then Mr. Keith Marhafka, and he is the environmental health and safety manager for building AB16. MS. CROWLEY: I'm sorry, I didn't catch the first and last names, if we could say them again. MS. HODGE: Steven Ziesmann, Z-I-E-S-M-A-N-N. Diane Beno. Robert Wells. You have that, and Mr. Keith Marhafka, M-A-RH-A-F-K-A. MS. CROWLEY: Thank you. MS. HODGE: And I have just a short opening statement to make, and then we'll

move on to our two witnesses for today. Abbott owns a pharmaceutical manufacturing building located at 100 Abbott Park Road in Unincorporated Lake County in Libertyville Township, Illinois. Abbott produces a number of pharmaceutical products at this facility. And these operations are subject to 35 Illinois Administrative Code, Subpart-T, Pharmaceutical Manufacturing. As 71 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 it is currently written, Subpart-T, and in particular section 218.480(b) contains certain exemptions that are applicable to Abbott's air suspension of coater dryers, fluid bed dryers, tunnel dryers, and accelacotas, a-c-c-e-l-a-c-o-t-a-s, located in building AB16 of the facility. Today through our testimony and in response to questions, we intend to demonstrate that Abbott's proposal to amend these site specific exceptions will, one, allow Abbott to use the combined actual emissions from its effective tunnel bed dryers and fluid bed dryers to determine the applicability of Subpart-T to these units; and, two, decrease the overall VOM emissions that would be allowed below the level of historical actual emissions from the tunnel dryers and fluid bed dryers as a group relating to the 35 Illinois Administrative Code, Section 218.480(b), the VOM exemption, while at the same time increasing operational flexibility by allowing preferential use of the more efficient dryer or dryers for a 81 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 particular manufacturing campaign. The proposed amendment also will not impose any new control requirements on any other source other than Abbott's facility. The proposed amendment will not result in any increase in emissions. First before offering testimony in support of our proposal, I would like to address a matter raised in the hearing officer order dated January 31, 2008. As you know, Ms. Crowley requested Abbott to address economic and budgetary effects, issues associated with our proposal. In that regard, the proposed rule if adopted by the Board apply only to specific emission units within Abbott's facility, and again the proposed rule will allow for increased operational flexibility at Abbott's facility which in turn will result in more efficient and cost effective production of pharmaceutical products. Moreover the proposal will not impose any new requirements upon the Illinois EPA, so there will be no budgetary effect. In light of the limited and site specific nature of the 91 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 proceeding and the information set forth in Abbott's proposal and the testimony to be presented today in answers to questions, Abbott believes there's sufficient information in this record for the Board to make an analysis of the economic and budgetary effects of the proposal. However, Abbott would be happy to answer any questions the Board may have on this topic. Abbott will present two witnesses today, and first Ms. Diane Beno. She is the plant manager of the portion of the Abbott facility internally known as Building AB16. Ms. Beno will provide information about the processes carried out in Building AB16 and the products manufactured at that location. Mr. Robert Wells is the air manager for environmental support in Abbott's Global and Environmental Health and Safety Department, and he will testify as to the technical description of the process and dryers at issue in this rulemaking. He will also discuss the current rule and explain how it

causes inefficiencies in the operations, and 101 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 then he will discuss the methods Abbott has utilized in an attempt to alleviate those inefficiencies. Finally, Mr. Wells will discuss the emissions from the effected dryers from both a historical and prospective perspective. The testimony of these two witnesses also will demonstrate that Abbott has worked closely with the Illinois EPA and the US EPA on this issue over the course of several years. We thank both the Illinois EPA and the US EPA for working with us in trying to resolve this issue and we appreciate Illinois EPA's participation here today. As set forth in Abbott's proposal that was filed with the Board on September 4, 2007, Abbott's testimony today will focus on the concept called the "Source Specific Emissions Cap EIP." Abbott included a full copy of the US EPA guidance document entitled "Improving Air Quality With Economic Incentives Program," and that was included as Exhibit 2 to our initial proposal. The EIP guidance provides direction on a number of 111 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 types of EIPs, including the source specific emission caps. The EIP guidance provides that there are fundamental principles that must be included in every EIPi number one, integritYi number two, equitYi and three, environmental benefit. All EIP's must contain four elements that compose the integrity principle: Surplus, quantifiable, enforceable and permanent. Second, with regard to the equity principle, all EIP's must contain an element of general equity. Finally as noted, all EIP's must demonstrate environmental benefit. A source specific emissions cap EIP allows a specified stationary source or a limited group of sources that are subject to

a rate based emission limit to meet that requirement by accepting a mass based emission limit or cap rather than complying directly with the rate based limit. The US EPA's stated goal for this type of EIP is compliance flexibility. Abbott in consultation with both the Illinois EPA and the US EPA relied upon and followed this 121 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 federal guidance in formulating its proposal. Mr. Wells will provide additional detail in how Abbott's proposal is consistent with the Federal guidance for source specific emissions cap EIP's. With that, if there are no questions, I would like to move ahead with the testimony of Ms. Diane Beno and Mr. Bob Wells. And Ms. Beno is going to, her testimony is short and she would like to go ahead and read that into the record. Bob's testimony, we're happy to enter into the record as if read, but he would like to offer

a summary, and we'll be happy to move to Board questions or, you know, to agency questions as appropriate. MS. CROWLEY: Can we go off the record for a one moment. (Discussion off the record, after which the following proceedings

were had:) MS. CROWLEY: Go back on the record. We discussed briefly entering some of the exhibits to the original proposal as hearing 131 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 exhibits just to keep the record tidy. So the first Exhibit will be Exhibit 1, which is

an aerial photograph of Abbott Park and vicinity in Libertyville Township and is so labeled. The second will be the US EPA document that is entitled "Improving Air Quality With Economic Incentive Programs" prepared by the United States Environmental Protection Agency, dated January 2001, and that is EPA document number EPA-452/R-OI-00l. And then finally, the third exhibit is Exhibit 3 entitled "Revised Exhibit 3," dated 2-29-08 entitled "Historical VOM Air Emissions From Tunnel Dryers And Fluid Bed Dryers At The Abbott Park Facility." For the record this is slightly revised from the copy that was attached as Exhibit 3 to Abbott's original September 4th proposal. So those

are marked and entered into the record as exhibits. Now you may proceed. MS. HODGE: Thank you. I do have extra copies of this pre-filed testimony here today, but I'm assuming everyone has a copy. 141 

### 2 3 4 5 6 

### With that, I think we're ready to move ahead with Ms. Beno. And I'm not sure how you want to handle the

-- MS. CROWLEY: I'm sorry, I didn't quite hear that. MS. HODGE: I think we're ready to 15

7 move forward. 8 MS. CROWLEY: Yes, go ahead. 9 (WITNESSES SWORN.) 10 DIANE BENO 11 Having been first duly sworn, was examined and 12 testified as follows: 13 BY MS. BENO: 14 Thank you for the opportunity to 15 speak here today. My name is Diane Beno. I am the 16 plant manager of the portion of the Abbott 17 Laboratories facility internally known as AB16. The 18 operations contained in AB16 produce intermediate 19 and final product formulations including liquids, 20 tablets, capsules packaged in bottles and blister 21 formats. The general process flow includes receipt 22 of raw materials, weighing of ingredients, massing 23 and granulation of ingredients, coating tablets or 24 particles, printing sYmbols onto tablets and

### 1 packaging finished products for distribution. 2 Over the course of a year we 3 produce many different products in building AB16. 4 For example, we produce products that treat diseases 5 in the field of neuroscience such as epilepsy and 6 bipolar disorder. We make anti-viral products for 7 the treatment of AIDS. We manufacture products to 8 fight infection. We package products that help 9 patients achieve healthy cholesterol levels and 10 products that improve the lives of people with 11 rheumatory arthritis, psoriasis and Crohn's disease. 12 We manufacture our products using batch production 13 processes. In batch production all of the 14 processing equipment in a process train, including 15 the dryers, manufactures one product at a time. 16 Each batch is completed before the manufacture of 17 the next batch begins. In a typical process, the 18 active and inactive ingredients are combined with 19 the liquid in a process called massing. The massing 20 process forms uniform granules. The wet granules 21 are dried in tunnel dryers or in fluid bed dryers 22 and then further processed into tablets or capsules. 23 The massing fluid which is typically either water or 24 ethanol is evaporated from the solid material in the 16

### 1 drying step. If an organic solvent is volatilized 2 from the dryer, it is emitted to the ambient air as 3 VOM or VOC. The quantity of VOM emissions will vary 4 for different products and is calculated from the 5 quantity of VOM added to the mixture and loss 6 factors defined for the dryers and specified in the 7 Clean Air Act permitting Program permit for the 8 facility. It's also important to note that the , 9 organic solvent currently used in granulation and 10 dried from the granulated mixtures in building AB16 11 is ethanol. Ethanol is a VOM, but it's not 12 considered a Hazardous Air Pollutant or HAP. The 13 proposed site specific amendment will have no impact 14 on HAP emissions. 15 Abbott's proposed site specific 16 amendment for building AB16 covers four tunnel 17 dryers and three fluid bed dryers. One additional 18 fluid bed dryer located in building AB16 is used 19 exclusively for research and development and is not 20 involved in the normal operating processes in 21 building AB16; therefore our proposed amendment does 22 not include that dryer. The tunnel dryers and fluid 23 bed dryers operate on different principles. We have 24 some diagrams here to help explain this point, so 171 I'll go ahead and pass these out. I think this will 2 help us make a point. I think this will be helpful 3 as we get into the pre-filed questions later on. So 4 as I stated 18

5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MS. CROWLEY: Just one moment. I'd like to mark this as Exhibit 4, if you have

no objection, and it's a single-page document with a heading "Granulation Process Fluid Bed Drawing. " Thank you. Go ahead. MS. BENO: The tunnel dryers and fluid bed dryers operator on different principles. In the use of tunnel dryers depicted on the lower half of the exhibit, materials are spread on trays and placed in a warming chamber or tunnel that circulates warm air

over and under the trays. As shown in the upper portion of the diagram, a fluid bed dryer is a large vertical cylindrical shaped vessel with a diffuser that blows warm air up from the bottom of the vessel. The wet intermediate granules are loaded into the dryer, and flow upward suspended in a warm air stream. Abbott has increased its use of1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 fluid air dryers for recently developed products because they are more efficient and produce a more uniform product than the tunnel dryers. Abbott anticipates increased

use of water for massing fluid in future products, and Abbott expects that this preferential use of fluid bed dryers and water based products will continue. That is, many new products are expected to use fluid bed dryers and water based formulations, while older products continue to be manufactured using tunnel dryers. Batches of specific products are typically manufactured using either one or

more tunnel dryers or one or more fluid bed dryers, but not both because the technologies

are not interchangeable. Individual dryers of the same type can typically be used in combination or interchangeably in many cases, but specific dryers are preferable for combining with other equipment in a process train to manufacture certain products from an operational efficiency standpoint. Abbott manufactures its batch 191 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 processes whereby each manufacturing process train and its associated equipment, including the dryers, produces one product at a time in fixed batch sizes. Process trains are designed to accommodate batches of different scales with some for large batches and some for small batches. Therefore, the scale of a given batch plays an important role in determining which of the dryers will be most efficient. Additionally, in accordance with the 

### u.s. Food and Drug Administration current good manufacturing processes, extensive equipment cleaning is required between batches of different products, resulting in up to three days of lost production time. Therefore Abbott uses a campaign strategy to continue running batches of the same product consecutively in the process train to minimize this cleaning time. As currently written 218.480(b) effectively defines a 12 month total VOM limit on each individual dryer. This can limit Abbott's ability to schedule the campaigns of certain products to maximize the 201 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 efficiency of the processes. In other words, to insure compliance with the current 12 month VOM limit on each dryer for a particular batch, Abbott may be required to utilize a dryer with a low VOM emissions during the last 12 months, instead of using the dryer that is most efficient from a production scale standpoint. Such selection of dryers is based only on the amount of VOM that has been emitted from an individual dryer during the preceding 12 months is an inefficient approach to the scheduling of Abbott's equipment and resources. Additionally, the dryer selected for a given campaign also depends on dryer availability and other factors. For example, 

### one dryer may be temporarily out of use to allow for cleaning or for unscheduled maintenance requirements; therefore the standards as currently defined can result in wasted

resources by requiring Abbott to dry a small batch of our product in our large scale process train to maintain our equipment specific VOM limits. Total annual emissions 211 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 from a dryer result in a quantity of organic solvent removed from the different products processed in a dryer over a 12-month rolling period. The material is processed in a number of individual campaigns for particular products each consisting of multiple individual batches. The assignment of a campaign of a particular product to one or

more dryers involves a number of operating factors, such as the scale and equipment availability that contribute to the efficiency of manufacturing. The VOM emission threshold effectively acts as an overriding factor that can force a particular production campaign with VOM emissions to be scheduled using equipment that has low enough recent emissions to avoid exceeding a dryer's threshold, but that may not otherwise be the optimal or most efficient equipment for the campaign. This scheduling shift increases the operational cost, but results in no environmental benefit because the actual emissions will be the same as if the campaign would have used the optimal equipment. 221 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 In order to assure Abbott's Lake County manufacturing facilities remain competitive with our national and global competitors Abbott must continually seek ways of making our manufacturing operations more efficient. The scheduling inefficiency created by Subpart-T was identified as one

area where improvements in efficiency could be made and is the basis for the proposed amendment. This seems particularly appropriate as the business costs created by this efficiency results in no environmental benefit. The most efficient method to manufacture Abbott's products in AB16 would be to use the dryer that is best suited to the requirements of the production schedule and scale, regardless of the amount of VOM that has been emitted from that dryer in the past 12 months. Provided that the combined VOM emissions from all of the dryers are less than the combined amount allowed under section 218.480(bl, this method of operation would not require an increase in allowable VOM emissions from the facility. In fact, 231 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 the proposed amendment would provide Abbott improved production flexibility to utilize the most efficient dryers for a given product while significantly lowering the total allowed VOM emissions for all of the dryers combined. Thank you. I'll be happy to

answer any questions. MS. HODGE: Shall we move on to Bob. Why don't you go through a summary of your testimony, and then we'll be happy to turn to the Board's questions well. MS. CROWLEY: That's certainly acceptable. MR. WELLS: I am going to attempt to summarize my testimony in a shorter summary than the actual testimony. My name is a Robert Wells. I'm air manager for Environmental Support in Abbott's Global EHS Department. I've been assisting the EHS staff with regulatory statutes with our proposal, and I'm going to touch on some of the technical points that relate to why we proposed what we did and where we see that 241 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 we're consistent with the approaches that we've proposed. The concern today is for provisions applicable to seven of the Abbott parking units, four tunnel dryers and three fluid bed dryers. Subpart-T requires VOM controls for tunnel dryers and fluid bed dryers if their annual emissions exceed seven-and-a-half tons per year for an individual tunnel dryer and five tons per year for individual fluid bed dryers. The

seven units therefore have a total potential emissions without control of 45 tons per year. Because of the cost associated with VOM control for this type of equipment, it is impractical to add control. So effectively the limits before control is required act as upper limits on the air emissions from the

seven units. The actual emissions from these units vary year to year based on the quantity of production and based on the different materials produced. In recent years the tunnel dryer emissions have varied from six-tenths of a ton to 5.6 per year, each 251 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 year. Fluid bed dryer emissions have varied from .1 tons to 3.9 tons per year each where the units have been operating. And you can

see from Exhibit 3 that's where those numbers

came from, although they were not in my pre-filed testimony. Abbott sought solutions to eliminate manufacturing constraints that effected the efficiency of the overall operation, and two options were initially considered. One be would be to request an increase in the threshold that would have to be exceeded before control were required, and the second would be to refine Subpart-T so that the individual unit control would be applied as a group to the combined emissions of the combined allowed emissions of the

seven dryers. We evaluated the alternatives, and we did some analysis that demonstrated to

us that it would be justifiable to increase the limit for each dryer, that the cost of control was such that at the levels that the threshold of requiring control and at higher levels, that the cost would be beyond 261 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 reasonably available control technology or RACT. Considering the combined emission controlled threshold, we determined that the flexibility that we were looking for would fit well within that so that there was -- we could go forward with that program without increasing the allowable emissions from the units. We discussed these alternatives with Illinois EPA and later with both IEPA and US EPA through our attorneys Hodge Dwyer Zeeman. And IEPA and US EPA identified a third alternative that was preferable to them and that was a source specific emission cap, SSEC, under US EPA's economic incentive program or EIP. The source specific emission cap would allow us to combine our future emission limits for all the dryers but set to

a limit below the historical actual emissions rather than the previously allowable emissions or emissions allowable without control. The historical emissions could be based on a concept called baseline actual emissions defined as the highest two year 271 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 period in the last ten years. I know there

was some confusion about that following my filing of the pre-filed testimony and we're prepared to answer that question in detail when we go through the prepared questions. This is a change from the original definition of historical actual emissions that the US EPA included in their 2001 guidance. Abbott reviewed the actual emissions that we've had from the dryers in the most recent ten years, and we identified the maximum two-year period with emissions of 22.9 tons per year in 1999 and 2000. As I'll discuss later, a reduction of ten percent of that level is applied to insure environmental benefit and that results in an emission limit for the seven units of 20.6 tons per year. This restriction would be less than half of the 45 ton per year effective limit that now applies to the seven units taken together. This significantly lower allowable limit though is acceptable to Abbott's anticipated business and meets our needs for flexibility. Abbott considered the requirements 281 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 of the EIP program in going forward with this in order to define our conformance with the three general principles for an EIP, integrity, equity and environmental benefit. Integrity, the integrity principle focuses on the emission reductions themselves and requires them to be surplus, bonafiable, enforceable and permanent. This proposal satisfies those conditions. The emissions

are surplus because our future allowable emissions will be below past baseline emissions for the dryers. Our emissions are quantifiable because the VOM emissions can be readily calculated from process record keeping as established in the facility's title five permit. The limits are enforceable because they will be included in Illinois's state implementation plan and also in our Title V permit for Abbott Park and they are permanent for the same reason. They will be established as continuing limits on

our operations. The proposed program satisfies the equity principle because it involves only 291 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 emissions at one facility. There is no instance of relative increases and decreases that must be balanced against one another. The program satisfies the environmental benefit principle because future emissions will be reduced by ten percent below our baseline actual emissions. So in summary, the proposal limits

our maximum future allowable emissions to a level below what we historically had really in the course of the variations in our manufacturing, but it will give us the flexibility to operate more efficiently. Thank you. I'll be happy to

answer any further questions. MS. HODGE: Thank you very much. We're ready to move on to the Board's questions unless counsel for Illinois EPA has anything now? MS. CROWLEY: If we could first mark

as Exhibit No.5, the pre-filed testimony submitted by Mr. Wells on February 22nd, as I'm sure he would like the complete testimony included in this record. 301 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MS. HODGE: Yes, he would. MS. CROWLEY: We will do that. MS. HODGE: Now, we'll turn to the questions of the Board that were included in the hearing officer order dated March 4, 2008. MS. CROWLEY: And let's mark that as Exhibit 8. MS. HODGE: And we're not going to read the questions. We'll just go straight to the answers, if that's acceptable. MS. CROWLEY: Unless you are more comfortable having us read the questions, we

can dispense with that. MS. HODGE: Okay. Then we'll probably

answer the questions certainly in order. And No.1, we'll start with

-- MR. WELLS: Question 1-A refers to whether the economic feasability for the original rule making still applies? The

answer to that is yes. As a part of this process we analyzed the cost of control using

a methodology developed by the United States EPA for what's referred to as BACT analysis, 311 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Best Available Controlled Technology, and using this analysis we found that the cost of control was continued to be significantly in

excess of what's normally considered reasonably available control technology. So essentially the economics have not changed. And as to question 1-B, there have been no fundamental changes in emission control technology that would be applicable to the facility since that original rule making. So what we were looking at were the same control technologies that were considered at that time. MEMBER RAO: We're fine with that. MS. HODGE: Thank you. And let's move

on to the Board's question No.2 dealing with emission trends. MS. BENO: Okay. 2-A is in regard to the lower actual emissions since 2000. That's due to many factors. For example, pharmaceutical manufacturing business activity is highly variable year over year. The types of products that we produce in a given year can vary based on a number of 321 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 market factors and patient demand. So therefore, as I stated in the testimony, different products emit different levels of VOM. So product mix is a primary factor in regard to the variability of our emissions. MEMBER RAO: Has there been any change in terms of production itself because when we look at this, we see some variation but there is also a significant, you know, reduction in VOM emissions since 2000? MS. BENO: As stated in the testimony many new products where possible utilize water based massing fluid, and so we make an attempt using water instead of ethanol or other VOM. So therefore the new products that have been introduced to the facility typically have used water based solvents. MEMBER JOHNSON: And there's no VOM produced when you use water as a fluid? MS. BENO: No, no. MEMBER RAO: Do you anticipate VOM emissions to increase over time? MS. BENO: We don't anticipate them to increase over time. 331 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MEMBER MELAS: I have a question. You stated earlier that the fluid bed drying is a

more efficient way of doing it. Do you contemplate over the course of time now that you will be phasing out the tunnel drying equipment and concentrate on buying or purchasing new fluid drying equipment? MS. BENO: No, that's not currently the plan. In fact, the products that we manufacture in the tunnel dryers, we will continue to manufacture those in the tunnel dryers. To switch between the technologies

can have an impact on the safety or efficacy of the drug product. So it would require a lengthy amount of process development and studies potentially, even clinical trials, so that is the lengthy FDA process I referred to. MEMBER MELAS: You say there is a

one-on-one relationship to the type of product to the type of dryer? MS. BENO: Yes, absolutely. MEMBER JOHNSON: Let me ask then. There is then in your mind a potential any 341 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 way that your company will begin some time in the future to manufacture products that either can't use the water as a massing fluid and have to use ethanol; there is a potential that you'll get back up to VOM rates comparable to what they were in '99 and 2000? MS. BENO: I wouldn't rule it out. It certainly wouldn't be our intent, but I wouldn't rule out the possibility. I'll move on to B? MS. HODGE: Yes. MS. BENO: B is in regard to tunnel dryer number four specifically, and in Exhibit 3 it was noted that there was no VOM from tunnel dryer three since 2005, and based

on Abbott's production needs, tunnel dryer No.4 has not been in use since 2005. However, it remains fully validated and maintained and available for use should production needs demand. So it serves us as

a back up in the event that one of the other tunnel dryers would become unavailable for

use. MEMBER RAO: Since the emissions for 351 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 all these dryers that you have listed in revised Exhibit 3 are significantly lower than the applicable limits, does Abbott have enough flexibility under the current rule itself or do you need to have the combined limit to provide you that flexibility? MS. BENO: We believe we need the combined limit to provide flexibility. MEMBER RAO: Can you explain a little

more why, if you don't have enough flexibility under the current rule? MS. BENO: It's based on the highly variable nature of the product mix in the facility. So in the event we were to run

more or some the products that have an ethanol based mass in fluid, it would prevent

us from using the most effective and efficient equipment. MEMBER RAO: Have you had that kind of situation in the past? MS. BENO: What specific situation? MEMBER RAO: Where you were not able to use whatever dryer you wanted to under the current rules. 361 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MS. BENO: It's become very close. MEMBER RAO: Looking at this data that you have provided, fluid bed dryer 3 obviously could be the one which is kind of closer to its limit? MS. BENO: Right. MEMBER RAO: Is that a situation where you see and you'd need to use another dryer similar to that again? MS. BENO: Yes, absolutely. Fluid bed dryer 3 in Exhibit 3, as you noted, has reached 3.9 in recent years which approaches

our current limit. MEMBER RAO: Thank you. MS. HODGE: Let's move on to the questions in the Board's order relating to the pre-filed testimony of Ms. Beno, and question No.1. MS. BENO: This is in regard to the type of organic massing fluid that we currently use, and ethanol has been the only organic massing fluid that we've used in building AB16 during the ten-year period under review for this proposal. I do want to 371 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 note that prior to late 2002 the type of ethanol used was denatured ethanol which contains a small percentage of methanol as the denaturant, but since late 2002 we've converted to all beverage grade ethanol which does not contain methanol as the denaturant. MS. HODGE: Question number two? MS. BENO: Again, number two is in regards for the basis for choosing the massing fluid, and the choice of massing fluid is dependent on the particular properties of a product. For example, the relative solubility of the product in either water or ethanol plays a key role in determining which solvent will be required for the massing fluid. So it's really related to the various properties of the product we're intending to manufacture whether or not water is an option for us or not. MEMBER RAO: So it's got nothing to do with the type of dryer you are using; it's all the product you are manufacturing? MS. BENO: No, either can be used in 381 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 either dryer. Water or ethanol can be used in either drying technology. MS. HODGE: Question number three? MS. BENO: No.3, this is in regard to increased use of fluid bed dryers and water for massing fluid. Abbott does in fact expect there will be an increased mass for water in new products as I indicated. It's not practical to change the ethanol based processes to a water based process because of the FDA considerations that I indicated before had the opportunity to influence the safety and efficacy of the product. But we do consider the type of massing fluid as we developed new products with a preference to using water. So accordingly we expect there will be an increased use of water for the massing fluid for new products. Questions there? B, this is in regard to the use of water to avoid VOM emissions. And in fact VOM emission avoidance is one of several factors that we consider as one of the benefits resulting from increased use of 391 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 water for the massing fluid. Other benefits include increased raw material costs, reduced worker exposure to organic materials in the work place and improved safety due to reduction of flammable solvents. In regard to C, water based products are preferable for a number of

reasons. As described previously, they are preferable because they don't contribute to VOM emissions, reduced raw material costs, reduced worker exposure and improve overall safety to the facility. Those were similar questions. In regard to the fluid bed dryers being more efficient, it's mainly related to the way they operate. If you refer to the diagram, you can see in a fluid bed dryer, individual granules, very small pieces of the product are airborne in the warm air stream and the air moves around freely on all surfaces of the particle or granule drying the drying process. This results in a much

more even drying process and higher quality end product because of the evenness of the 401 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 drying. Tunnel dryers on the other hand are like cookie sheets in an oven. You hand-load the material onto the cookie sheet, onto the big rack, push the rack into the tunnel dryer and it's exposed to air movement in the tunnel. What can happen in a tunnel dryer similar to in baking, you could have parts of the cookie that are more done than other parts of the cookie. Whereas in the fluid bed drying technology, a smaller portion of the product is exposed to the warm air across the entire surface. So it makes for a much

more uniform drying process which makes the downstream processing much easier. MEMBER RAO: I think you answered 4B already. MS. BENO: Yes, yes. Thank you. MS. HODGE: Number five? MS. BENO: Selection of the dryers. One example of the inefficiencies created by the current rule is that the most appropriately sized equipment may not be chosen. As I mentioned in the testimony, we have small scale process trains and large 411 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 scale process trains. Now, in the event that the small scale process train would be approaching its limit, we may be forced to

use the large scale process train to process smaller batches than would normally be processed in that particular process train. So that is the main consideration in regards to inefficiency of the scheduling that could be influenced by the current rule. It's much like flying a plane half full or running a dishwasher half full, you are not utilizing the full capacity of the equipment in that particular area. MR. RAO: In this regard, I didn't see any information about the drying capacity of these dryers. Are they all about the same or each dryer is different. MS. BENO: It has to do with the processing suits that they are in. We have

one dryer in one processing suit, and we have two dryers in another processing suit. That's our large scale processing train

versus our small scale processing train. As I mentioned, you can only run one product in 421 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 a process train at any given time. MEMBER RAO: Thank you. MS. BENO: So there was one final question regarding how we select which dryer to use for a given campaign. And the selection of dryers is mainly based on the technology first. As I mentioned there is a

one to one relationship of which product goes in which type of technology. Meaning a tunnel dryer or a fluid bed dryer. The second consideration would be the scale, whether it's a large scale batch or a small scale batch, and then the third consideration is general availability; do we have more products running in one size suit than the other or is one of the suits down for maintenance or cleaning. So those are the critical factors that we consider when scheduling the production in the dryers. MEMBER RAO: Thank you. MEMBER JOHNSON: The amount of VOM produced is dependent upon the amount of ethanol, use not on your choice of which drying

-- 431 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MS. BENO: Absolutely because we're going to be drying to the specification of the product so we'll always be drying off the

same amount of VOM for a given product for a given batch. MS. HODGE: Thank you. Anything else? MS. CROWLEY: Mr. Matoesian, have you had any questions? MR. MATOESIAN: No, not so far. MS. CROWLEY: I've been keeping an eye

on you, but I just wanted to state it for the record. MS. HODGE: Let's move on to the questions of the pre-filed testimony of Mr. Wells. MR. WELLS: I talked briefly earlier about the two-year period. What has happened is that there has been a change in philosophy

on the conceptual level in US EPA's application of historical emissions. The definition of historical actual emissions that appears in the 2001 guidelines, the US EPA developed is the same

as the concept in prevention of significant 441 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 deterioration, PSD, or non-attainment new

source review, netting that US EPA has previously used and what was in place at the time; that is , the two years immediately preceding the action or another two year period, if it's determined to be more representative. There's been a lot of problems historically in the determination of whether a particular period is representative, and the US EPA in 2002 changed the definition of actual emissions. They defined a term "baseline actual emissions" for the PSD and the non-attainment

new source review program. And what they said was that you can use any 24-month period in the preceding ten years. That assures that you can look back far enough to see a representative business cycle so that you can

see the periods when your normal fluctuation of business would result in relatively higher emissions. But at the same time it gives a simple concrete basis to make that decision. That was originally suggested to us in the conversations that our attorneys had with 451 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 IEPA and with US EPA. That was the recommended interpretation at the time, and

as we understand it, US EPA guidance is now, their guideline on the EIP process, which is not a regulation. It is guidance, is being interpreted differently to allow the use of that two-year period as far back as ten years. I'll also point you to the revised Exhibit 3. If you notice, 1999 and 2000 were the highest years. 1998 was actually lower than the emissions in either 1999 or 2000. So it is in fact a peak that we are talking about rather than just a continuing decline. MEMBER RAO: And, Mr. Wells, do you have any specific US EPA publication or memorandum that talks about this change in their policy? MR. WELLS: Well, the baseline actual emissions were established in a federal register notice amending the PSR rules at 67 Federal Register 80.186. MEMBER JOHNSON: We, as good corporate citizens, it's to your benefit to keep your VOM emissions as low as possible, but what 461 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 you want to be able to do, at least I take it is, that the demand for whatever product you

are producing in 1999 and 2000 were to return and you had to use the same drying system or

use the ethanol rather than water on that to develop that or make that particular product, you want to be covered so that you can do that and fulfill the demand. And that's why

even though these VOM emissions are at least twice as much as the next five years, that's why you want to have that set as your baseline? MR. WELLS: Exactly. MS. HODGE: And, again, just to note for the record, that historical baseline is being reduced by ten percent, you know, in the limit that we're requesting. MEMBER JOHNSON: And in fact, the reduction from what it is now is significantly more than that. If you ran all of your dryers at capacity, you would produce 45 tons, and this site specific rule as proposed reduces that by over 30 tons, right? MEMBER RAO: Half. 471 2 3 4 5 6 7 8 9 10 11 

### 12 13 14 15 16 17 18 19 20 

### MR. WELLS: Over half, a little over half. MEMBER RAO: Thank you. MR. WELLS: Question two, I think it kind of follows question one. MS. HODGE: We're good there. Shall

we move on the economic incentive program guidance? Question No.1. And this is something that we thought might be more properly addressed to the Illinois EPA. MR. MATOESIAN: That's fine. Charles Matoesian speaking. With me today I have Mr. Yoginder Mohajan (Phonetic), who is an engineer with the Illinois Environmental Protection Agency, he is here to answer some questions from the board. He is currently in the air quality planning section of the Bureau of Air and has prepared some answers for these questions. MS. CROWLEY: Would you swear him in? 48



### 21 YOGINDER MAHAJAN 22 having been first duly sworn, was examined and 23 testified as follows: 24 Question No. 1 on page three, the1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 guidance states that the guidance applies if state applies

-- MS. CROWLEY: Off the record. (Discussion off the record.) MS. CROWLEY: Go back on the record. MR. MAHAJAN: The answer to the question, I spoke with the US EPA, Mr. Steve Rosenthal. He told me that the option of the EIP is not required. It is recommended. It is nice if you have it adopted, but it's not required and the agency's intention is not to adopt it. It will deal with it on a case by

case basis. Question No.2, yes, the agency has discussed this with the US EPA and confirmed that this amendment is consistent with the EIP guidelines. No.3, yes. And question No. 3B is also no. Regarding emissions being surplus is there any concern? No we don't have any concern. It's discussed with the US EPA, and they said that it is consistent with the EIP guidelines. MEMBER RAO: Thank you. 491 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 MS. HODGE: Do you have any other questions? MEMBER RAO: There was one question about the proposed amendment. MS. HODGE: We're ready to move to that. MEMBER RAO: No follow-ups. MS. CROWLEY: Do you have any follow-ups for this. MS. HODGE: No. So we'll move on to the question on the proposed amendments, question No.1. MR. WELLS: Yes. The only concern that we had with the specification of the equipment was that we not specify that

-- 28.480(b) now covers the entire facility,

more than just building AB16. We would not have a problem if the specification were made

on the SSEC that we've been discussing today. As far as specifically 218.480(b) (4), as far

as the general applicability of 218.480(b), it's our understanding that still applies to the facility, and it is possible that we might find the need to install a fluid bed 501 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 dryer in another building for a totally unrelated manufacturing process. MEMBER RAO: You are comfortable with the way the rule is proposed now? MR. WELLS: That's correct. MEMBER RAO: I think that question was triggered because the way 218.480(b) is now currently written, Abbott's name is not mentioned in that section at all. And I know it's highly unlikely that somebody else would set up shop with four dryers and give them

names and take advantage of this rule, but in most of our site specific rules we have the

name of the company involved in it. So I just wanted to know what your thoughts were

on it. MR. WELLS: In terms of identifying the company, I don't think we have any objection to it. The drafting of the original rule was before my time. I'm not

sure where the language came from, but that wouldn't be a problem. Again, the only thing

we wanted to be sure was that it wasn't defined specifically to cover building AB16, 511 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 just to allow us the same flexibility in the future. MEMBER RAO: Okay. MEMBER JOHNSON: The road is named after you so -- MEMBER RAO: Thank you very much. MS. HODGE: Thank you. We have one more issue that we'd like to address, and this deals with a request that has been made by US EPA through the Illinois EPA, and they had asked if we could submit to them some of the supporting emission calculations for the baseline years, 1999 and 2000. We've talked with IEPA about how the emissions are calculated and US EPA wants a little bit more information. We are currently preparing that, and we will submit additional information in response to that request subject to CBI, confidential business information requirements on that. So that will be forthcoming, and I understand from talking with counsel for IEPA, that you would like to have some of that in this board's record, that IEPA would like to have some of 521 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 that in the Board's record. MS. CROWLEY: I understand that. Please if any of it is confidential business information or trade secrets, that when it is submitted that it is properly submitted with

a redacted copy, as well as the copy that you would like to have protected so that there isn't any problem with that. MS. HODGE: We can do that, and we will work with IEPA and Mr. Steve Rosenthal at US EPA to make sure that everyone is comfortable with what we submit. With that, I don't have anything else. MR. MATOESIAN: We have nothing. MS. CROWLEY: One little left over bit

was the motion to file the amendment, Exhibit 3, and the motion to amend the proposal specifically as it regards proposed 218.480(b) (4) to reflect the change to the 90 percent baseline calculations. Do you have any objection to that? MR. MATOESIAN: No. MS. CROWLEY: Thank you. That motion 531 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 then is granted. Let's go off the record for

a moment. (Discussion off the record.) MS. CROWLEY: Back on the record. We have had a brief discussion about what would be a reasonable post-hearing comment period. We have chosen May 1st as the close comment period date subject to an extension if necessary to allow completion of data gathering for US EPA or if any other person needs additional time. We specifically do request that the agency file, even if short,

some comment on this record indicating their view of whether this rule should or should not be granted. If there is nothing else

-- MR. MATOESIAN: We can say, the Agency

can state that it supports the petition. MS. CROWLEY: Okay, fine. If there's nothing else then, I thank you all for your participation. The Board again thanks Abbott for its patience in bearing with our scheduling problems. We will try to render a decision in an expedited fashion once the record is closed. Again, thank you all very 54

### 1 much. 2 STATE OF ILLINOIS SS. 3 COUNTY OF COOK 4 

### 5 I, DENISE ANDRAS, being a Certified 6 Shorthand Reporter doing business in the City of Des 7 Plaines, Illinois, County of Cook, certify that I 8 reported in shorthand the proceedings had at the 9 foregoing hearing of the above-entitled cause. And 10 I certify that the foregoing is a true and correct 11 transcript of all my shorthand notes so taken as 12 aforesaid and contains all the proceedings had at 13 the said meeting of the above-entitled cause. 14 15 16 

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### DENISE Andras, CSR CSR NO. 084-003437