## EXHIBIT LIST R08-8 JEPA ATTACHMENT NO.

# J.E. RECEIVED 

# ,/\ L CLERK'S OFFICE

, ': I',
. 

## MAR 282008 STATE OF ILLINOIS Abbott Laboratories' Proposed Site-Specific Amendment to Applicability**SectiorPQlI'eY~wntrol** 

### Board Material Emission Standards and Limitations for the Chicago Area: Subpart T: Phannaceutical Manufacturing (35 Ill. Adm. Code 218.480lb» Exhibits submitted at hearing March 7,2008 Exhibit 1 Exhibit 2

Exhibit 3
Exhibit 4
Exhibit 5

Exhibit 6 Aerial Photograph ofAbbott Park and Vicinity (single page) Improving Air Quality with Economic Incentive Programs, Doc. No.EPA452/R01-00l, United States Environmental Protection Agency, Office ofAir and Radiation, Office ofAir QualityPlanning and Standards (January 2001) Revised Exhibit 3 (2/29/08) "Historical YOM Air Emissions from Tunnel Dryers and Fluid Bed Dryers at the Abbott Park Facility" (single page) Chart, "Granulation Process-Fluid Bed Drying" and "Granulation ProcessTunnel Drying" (single page) Pre-filed testimony ofRobert C. Wells, Air Manager for Environmental Support, Abbott Laboratories Environmental Health and Safety Department (as filed with the Board February 22,2008) March 4, 2008 Hearing Officer Order in R08-8 containing "Questions on Proposal and Pre-filed Testimony"

# o 

# o A660IT PROPERJY**flOUNDA~** flUID flED**D~RS** 

## * TUNNEL DRYERS**lU_t~~~~:::~~,:,!?amu., .~_ao.,.,aOO7** 

EXHlfllT I AERIAL PHOTOGRAPH Of Afl60IT PARK AND VICINIIY L1flERTYVILLE TOWN5HIP. ILLlNOl5**Ar~R.O)(JMATI:** 5CALr:' I' _1000'_0" 300 100 500 1000 2000 2000Electronic Filing, Received, Clerk"s Office, September 4, 2007 

### * * * * * R200S OOS 

### * * * * *

United States Environmental Protection Agency Office of Air and Radiation 

# R08-b'0 

# .• 3'- 7

# -oct EPA-452/R-01-001 

### T;./"". January 2001 

# 3EPA 

# Improving Air Quality with Economic Incentive Programs

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

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

## * * * * * R2008 008 

## * * * * *

EPi\-452nR-01-001



# IMPROVING AIR QUALITY WITH ECONOMIC INCENTIVE PROGRAMS

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

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

U.S. ENVIRONMENTAL PROTECTION AGENCY Office ofi\ir 

### and Radiation Office ofi\ir 

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

## * * * * * R2008 008 

## * * * * *

This page intentionally leftblank.Electronic Filing, Received, Clerk"s Office, September 4, 2007 

## * * * * * R2008 008 

## * * * * *

TABLE OF CONTENTS Selecting and Approving EIPs 1.0 General 3 1.1 What does this Federal EIP guidance cover? 3 1.2 Who should follow this guidance? 5 1.3 Why should I develop an EIP? 5 1.4 What are the goals ofthis guidance? 8 1.5 How does this guidance affect the EPA's 1994 EIP rule? 8 1.6 How does this guidance apply to existing EIPs? 9 1.7 Whatprograms are not coveredby this guidance? 9 1.8 What is the general process for getting my EIP approved? 11 1.9 What does the EPA mean when it says this is guidance? 12 2.0 DefiIring an EIP
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 2.1 What is an EIP? 15 2.2 Whatpollutants are covered? 16 2.3 What sources may I include inmy EIP? 16 2.4 What are the objectives ofEIPs? 16 3.0 Selecting YourEIP Type 17 3.1 How do I selectthe type ofEIP that will workbest for me? 17 3.2 Whom should I involve in selecting and developing my EIP? 28 3.3 How do I apply this guidance to a particulartype ofEIP? 29 Elements ofAll EIPs 4.0 Fundamental Principles ofAll EIPs 33 4.1 How mustmy EIP meetthe integrity principle? 34 4.2 How mustmy EIP meetthe equityprinciple? 45 4.3 How must my EIP meetthe environmental benefitprinciple? 49 5.0 Common Elements ofAll EIPS 53 5.1 Whatprovisions do I need to incorporate my EIP into my SIP? 53 5.2 How do I quantify the results ofmy EIP? 59 5.3 What features must I include in my EIP to measure and trackresults? 66 6.0 Elements ofAll Trading EIPs 73 6.1 What enforcement elements must 

### all trading EIPs contain? 73 6.2 Whatprovisions do I need in my trading EIP to address specific pollutant effects? 76 6.3 Whatprovisions do I need in my trading EIP to ensure it does not interfere

1Electronic Filing, Received, Clerk"s Office, September 4, 2007 

## * * * * * R2008 008 

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

### 77 6.4 Whatprovisions do I need in my trading EIP to 

### address uncertainty? 79 6.5 What otherprovisions do I need in my trading EIP? 81 6.6 Are "emissionreductions" the same as "emissionreduction credits (ERCs)?" 87 7.0 Elements ofSpecific Trading EIPs 89 7.1 How do I selectthe appropriate trading EIP? 89 7.2 What otherprovisions do I need for my emission averaging EIP ? 91 7.3 What additional provisions do I need for my source-specific emission cap EIP? 94 7.4 What additional provisions do I need for my multi-source emission cap-and-trade EIP? 98 7.5 What additional provisions do I need for my open-market trading EIP? 105 8.0 Elements ofFinancial Mechanism EIPs 113 8.1 Whatprovisions must all 

### financial mechanism EIPs contain? 113 9.0 Elements ofClean Air

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

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

### "voluntary measures" progrcrrns different from EIPs? 131 Other Requirements for EIPs 

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

### demonstrate my EIP is complete? 135 11.3 Whatmust I submitfor approval if

### my trading progrcrrn involves more than 

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

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

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

### ittake to 

### getmy EIP submittal approvedby the EPA? 138 11.6 What final actions can the EPA take on my EIP SIP submittal? 138 11.7 What does itmean if

### the EPA does not :fully approve my EIP? 139 11.8 Whathappens if! implementmy EIP before the EPA approves it? 140 12.0 Running YourApproved EIP 141 12.1 What are my responsibilities forrunning my EIP once it is approved? 141 12.2 HowmustIenforcemyEIP? 141

nElectronic Filing, Received, Clerk's Office, September 4, 2007 

## * * * * * R2008 008 

## * * * * *

12.3 How must I evaluate my EIP? 142 12.4 How must I reconcile any problems? 142 12.5 How must I update inventories? 143 

### Other Important Information You Need to Know 13.0 Additional Guidance That Applies to EIPs 147 13.1 What additional guidance must I use for specific EIPs? 147 14.0 Mobile Source Guidance You May Use Instead ofThis Guidance 149 14.1 What guidance may I use instead ofthe EIP guidance? 149 15.0 Special Terms You Need to Know 153 15.1 Glossary 153 15.2 List ofacronyms 166 16.0 Appendices 171 16.1 Special Provisions for Areas Needing and Lacking Attainment 171 16.2 VOC EIPs involving hazardous airpollutants (HAPs) 175 16.3 Emission quantificationprotocols for OMT EIPs 188 16.4 Guidance on Voluntaty Emission Reduction Programs 199 16.5 Ensuring Adequate Public Participation 225 16.6 FLM Notification Requirements 229 16.7 Area-wide RACT provisions 231 16.8 Provisions for sources with Title V permits 232 16.9 Provisions for ozone inter-precursortrading 235 16.10 Provisions to ensure consistency with transportation conformity 238 16.11 Provisions for localized increases ofcriteriapollutant andprecursor emissions 240 16.12 Provisions for inter-credittrading 242 16.13 Provisions for EIPs that include RACT sources 243 16.14 Provisions for new source review and trading 246 16.15 Provisions for banking emission reductions 249 16.16 Provisions for geographic trading acrossjurisdictional boundaries 256 16.17 Safeguards for EIPs that allow the use ofold emissions reductions 258 16.18 Provisions for opt-in sources 260



### iiiElectronic Filing, Received, Clerk's Office, September 4, 2007 

## * * * * * R2008 008 

## * * * * *

List ofTables 

### Table 1.1: EPA Regional AirDivisionDirectors 7 Table 3.1: Characteristics ofEIPs 18 Table 3.2: Which Sections ofthis Guidance ShouldI Read? 30 Table 4.1 (a): Programmatic Integrity Elements 37 Table 4.1(b): Programmatic Integrity Element ofSmplus for Trading EIPs 38 Table 4.1(c): Programmatic Integrity Element ofSmplus for OtherEIPs 38 Table 4.2(a): Source-Specific Integrity Elements 40 Table 4.2(b): Comparison ofSource-Specific Integrity Elements for Trading EIPs 42 Table 4.2(c): Comparison ofSource Specific Integrity Elements for OtherEIPs 44 Table4.3(a):General Equity Principle for Trading EIPs 47 Table 4.3(b): General Equity Principle for OtherEIPs 47 Table4.4(a): Environmental Justice Elementfor Trading EIPs 49 Table 4.4(b): Environmental Justice Elementfor OtherEIPs 49 Table 4.5(a): Environmental BenefitPrinciple for Trading EIPs 51 Table 4.5(b): Environmental BenefitPrinciple for OtherEIPs 51 Table 7.1: Characteristics ofTrading EIPs 90 Table 10.1: Examples ofPublic Infonnation EIPs 130 Table 16.11: SignificantAnnual 

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

IV

## ~08--g> 

# tr 3**3-7~D** 

# 9'**I~**

Electronic filing. Received, Clerk·s Office, February 29, 2008**Revh~edExhibit** 3 (2129108) Historical YOM Air Emissions from Tunnel Dryers and Fluid Bed Dryers at the Abbott Park Facility- (tons peryear) C

Tunnel Tunnel Tunnel Year Drver 1 Dryer2 Drver3 1998 2.65 2.19 2.59 1999 4.52 5.58 5.31 2000 3.79 4.01 3.15 2001 0.70 1.60 1.70 2002 1.80 1.80 1.80 2003 2.40 2.10 2.20 2004 3.40 1.70 1.50 2005 2.10 1.50 1.20 2006 1.00 1.11 0.91 2007 1.71 0.69 1.03 Averaae of Years 1999 &2000 (baseline) 90 Percent of Baseline Notes to Exhibit 3 Tunnel Drver4

3.27 5.16 3.30 1.30 1.20 1.20 0.60 0.00 0.00 0.00 Fluid Bed Drver1

1.34 2.35 3.16 1.70 0.90 1.00 0.00 0.10 0.66 0.41 Fluid Bed Drver2

1.12 2.15 3.16 1.60 0.90 1.00 0.00 0.10 0.66 0.41 Fluid Bed Drver3

b b 0.17 1.70 3.10 2.90 3.90 3.00 2.97 3.19 Total Tunnel Dryer emissions 10.7 20.6 14.2 5.3 6.6 7.9 7.2 4.8 3.0 3.4 Total Fluid Bed

Dryer EmiSSions 2.5 4.5 6.5 5.0 4.9 4.9 3.9 3.2 4.3 4.0 Total Dryer VOM Emissions

13.2 25.1 20.7 ·10.3

11.5 12.8 11.1 8.0 7.3 7.5 22.9 20.6

a emissions ofYOM were calculated based on records ofproduction batche$. corresponding YOM contentofVIe batch, and specified loss factors forthe respective equipment, as detailed in CMPP Permit section 7.1.12(e). b Fluid Bed Dryer3 was not operating prior to 2000. c Some datawere included in calculations to more precision t1lan 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.Fluid Bed Dryer Bowl Dry Product Fluid Bed

Dryer

Wet Product Fluid Bed Dryer Bowl Air Exhaust -_ ••••**,~~** . •wm._w•••

__ •••**~.www** •••••••.. _._••

_ .••.•.**-:~i:-~I.** 

### Granulation Process - Fluid Bed**D~**

# ~~**~ep**

# ~~

• Air Inlet



## [- ·**,_~~.__m** 

## '._
.. 

# ..1

Granulation Process'" Tunnel Drying 

# I

Dry Product Air Exhaust Air Inlet
Wet Product

Masser

Tray Rack Tunnel Dryer

### Electrb'riic;,' 

### Filing' .,;,**Received,~ Clei'k~'** **'O,ffice~** 

### February 22j 200'8


### .a2FORB THE,ILLfllfOIS POLLUTION

### CONraOL

### BOARD**.~.** - 

### INTHE 

### MATTEROF: ) '- )



### ,**A.BaOTr.-LABQRATqRIJ~s·~p.Ro;eOSED** 

### ). SITE-SPECIFIC AMENDMENT TO ) 

### AP:?LICABl;J;.,IT¥·SEGTION,OF

### O.aOANIC: ) MATERIALEMISSION STANDARDS AND) LIMITATIONS 

### :POR CHICAGO .A.REA;) SUBPARTT: PHARMACEUTICAL ) MANUFACTURlNG (3S 

### ILL. ApM. CODE ) 2l8.480(b» ) R08,;,8 

### (Rulemaking -Air) 

# 'fRD3-g .'**~,.5** 

# 3-07-t?? !(;u-<-'

- .. PRE-FILED TESTIMONY OF ROBERT C. WELLS, IN SUPPORTOF 

### PROPOSED SJTE..SPECIFIC AMENDMENT
. 

### NOW COMES,ABBOTTLABORATORIES, 

### by and through its attorneys,**~ODGE** 

### D.WYERZEMAN, andpursuantto· 35 Ill. Admin. Code 

### § lO2.424 

### and-the Hearing Officer Order, dated

### January 31, 2008, 

### submits the following Pre-Filed Testimony ofRobert C. Wells for presentation at the March 7, 2008 hearing scheduledin the 

### above-referenced matter: TESTIMONY OFROBERT C. WELLS 

### My Dame 

### is**Rob~rt** 

### C. Wells. I am employedby Abbott Laboratories as 

### Air Managerfor Environmental Supportin Abbott's Global Envirorunental Health 

### and Safety Department. 

### ,I pro'videassistance to 

### Abbottfacilities such as Building 

### AP16 withregard to environmental compliance 

### and managing environmental performance at ourfacilities under various air

### regulations. Ihave twenty-nine years ofexperiencein air quality 

### managementand the 

### analysis ofairemissions, emission control 

### and ambient airquaIity. I hold aBachelorofSciencedegree 

### in Engineering

### from Cornell 

### University. My testimony today**conc~ns** 

### technical aspects of

### Abbott's proposal'fara sitespeCific amendment'to Illinois air regulations at 

### 35 Ill. Admin. Code**P~rt** 

### 218.480(b), in

### SubpartT of-Part 21.8, Abbottts 

### proposed site-"specific

### amendment'concerns provisions impacting the four(4) tunnel dryers (also referred to as warm air

### dryers)
..andthree (3) fluid bed dryex:s located'in BuildingAP16 atthe Abbott Parkfacility" The'dryers are 

### usedto dry. 

### mixtures ofacti:ve 

### pharmaceutical ingredients**eAPls~');** 

### exoipient

### ingredientst 

### and massing fluid afterthey have beenprocessedto 

### 'produce asolid material withim appropriate granule size. The granulatedmixtureis then

### usedto manufacture dosage 

### fomi products (i.e.; tablets,**cap~es,** 

### and granules). The 

### tunnel dryers 

### andfluid beddryers are

### currently subjectto air

### reguIatiC;lns for Volatile Organic Material ("VOM") emissions 

### under 35 Ill. Admin. CodePart218,

, Subpart T. Under this'standard, anindividual dryer

### is required to control VOM

. . 

### emissions iHts annualemissions exceed 7.s 

### tons peryear (tonlyr) 

### for a·tunnel dryer or 5 . ton/yrfora fluidbed dryer,· Emissions from anyone dryervary from yearto year, Historically, emissions from eachdryerhave been significantly below the level that

### would triggerthe requirement. for

### add·on 

### control. Emissions from individual dryers have**b~en** 

### held below these limits·in part 

### byplanning 

### productionto distribute YOM.em.ittingproduction among the differentequipment.. 

### Because Qfthe v8l'iability; and 

### because ofthe significant costto 

### install and operate**con~ols** 

### for 

### adryer.that

### wouldnotbe

### justified, these 

### control thresholds effectively act as the upperlimit for annual YOM 

### emissions from an· individual 

### dryer. At this 

### time, 

### production scheduling can beforced to 

### assign 

### one ormore dryers 

### to
aproduction campaign based onthe dryers' recentpastYOM emissions, assigning one or
more dryers thathave low

### enough recent emissions to avoidexceeding a dryerthreshold, 

### 2

### butthatmaynototherwise 

### bethe optimalormost.efficient equipinentforthe 

### campaign. This scheduling shift 

### increases the operational cost, butresults 

### in·no environmental. benefit, because 

### the.actual emissions WIll bethe same as ifthe campaign wouldhave used the 

### optimal equipment; This scheduling 

### inefficiency was 

### identified as 

### onearea whereimprovements in efficie4lcy could be made, while not

### mcreasingthe enviroi1mental impact ofAbbott's operations. Two environmental managementapproaches wereidentified and considered in orderto.alleviate the inefficiency ofthe·SubpartTopetating constraints. One alternative 

### wouldbe to increasethe thresholdthatwould triggerthe emission control requirementfor
one ormoreindiviclual dryers. Suchanincreasewould 

### bejustified if

### the cost·ofcontrol is greaterthan whatis considered economi<::ally achievable forReasonably Available Control Technology ("RACT"), which was thejustificationfor establishing·the original thresholdsin SubpartT. Apreliminaryreview

# o.femission controlcosts indicated that RAeT 

### controls would not bejustified 

### even atemissionthresholds significantly higher than:the current limits specified in Subpart T. 

### Asecond alternative would'be totreatthe
. currentcontrol threshold as a combinedthreshold·equal to

### the sum. 

# .ofthe individual unit thresholds for the· seven manufacturing dryers. This apprpach would remove a . manufacturing· constraint withoutincreasingthe**all~wable** 

### VOM emissions fromthe facility.The above alternatives werefirst 

### evaluatedinternally within Abbott. Under the fIrst**approac~** 

### while Abbottbelieves thatit would,bejustifiable to increasethe emission

. thresholdforone ormore dryers, itwould also actto increase

### .the facility's 

### allowable

emissions. which is not

### necessary to solve problems ofmanUfacturing 

### effioiency. The 3 

### )

## )

)**Ele'ctrohic~Fmng** 

### • 

### ReceivedrClerk!-s :Officej**F~br-i.iary** 

### '22,. 200.8



### . . second

### approach,'to r&odefinethe'emissipn threshold,as acombinedthresho14.for all dryers, would remedy manufacturing inefficiencies without-**inc~easing** 

### overall aUQwable VOM·emissions. Both 

### of these 

### approaches were discussed withthe·Illinois Environmental Protection Agency**('~IIlinois** 

### EPA''). AHhat**time~** 

### lllinois BPAindicated

### tha,t

### botI, Illinois EPApolicy and United'States EnvirtifuneJital. Protection-Agency{"USEPN') regulations 

### and,guidelines would 

### need 

### to;be considered

### in order

### for'the agency40 

### support
a site.specific·amendmentto 

### 35m. Admin.**~ode** 

### Part,218.· Subsequentdiscussions among Illinois EP USEPA, 

### andAbbott's 

### representatives identifiedan existing USEPA

### programthatwould 

### providesin)ilar operational benefits as 

### the combinedthreshold.approach 

### discussed above. USEPA's Economic lncentive 

### Programs ("EIPs") are 

### describedin

### -USEPA's. document, 

### Imp"oving Air Quality With Economic lricentive.t}irograms,**BPA~4521R·Ol·OOl,** 

### January 2001, whichwas 

### provided as 

### Exhibit.2 to the Statement

### ofReasons.forthe proposed 

### site-
. speCific amendment Among other**programs~** 

### this guidance 

### includes provisions 

### for; a Source-Specific Emission Cap (4'SSEC") as 

### an altemativeregulatory approach for emission 

### limits that

### can·regulate emissions 

### with greaterflexibility and efikiency 

### than conventional approaches. 

### DiSCuSsions with 

### nlinois
..EPA andUSEPA indicated that 

### a SSEC could 

### allow

. individual.emission limits to be combinedinto anaggregate**cap:for~the** 

### tunnel dryers and fluid bed**dryers~ pr~vided**  that

### the SSEC is setto a·lev.el which 

### is less thmi the

### upits combinedhistorical actual emissions, ratherthan**equ~l** 

### to currentcombined 

### allowable emissions. Both 

### Illinois EPA and USEPAindicatedthat 

### a: 

### SSEC EIP would be 

### an 4 . ,Electronic Filing - Received, Clerk"s Office, February 22, 2008 

### acceptablemethod to 

### address the 

### applicabilityprovisions ofSection218.480(b) with 

### respectto 

### AbbQtt's tunnel 

### dryerS and fluidized 

### bed dryers. Underthe current 

### regulatorystandard, the 

### combined allowable 

### emissionthreshold for

### Abbott's dryers

### is 4S ton/yr ofVOM emissions. This is based on 

### the sum ofthe allowable emissions for fOUf

### tU1U1el dryers at

### 7.5 tonlyr 

### each and three fluidbeddryers at 5,0 tonlyr each. 

### A SSEC withinthe

### EIPs would typically 

### require allowable emissions to be 

### reduced below abaseline 

### level"definedby 

### the historical actual emissions for

### the"units. UnderUSEPA guidelines,**hist~rical** 

### actual emissions are defined as the 

### highest actual 

### emissions from any 2-year

### periodwithin the last 10 years of

### operation. In 

### addition, 

### the EIP requires ademonstration ofenvironmental 

### benefit which canbe achieved by 

### setting
an emission limit 1{j 

### percent below the baseline 

### emissions. Such aprogram would be
more constraining than either

### ofthe two 

### altematives proposed by 

### Abbott. 

### However, while eitherofAbbott's 

### original alternatives 

### would likely be approvable, it

### was recognizedthat 

### it would bemore administratively efficientto 

### work within 

### the."EIPs framework 

### ifitwere otherwise acceptable to 

### achieve Abbotfs 

### goals. Abbott

### reviewed its historical actual 

### emissions to 

### determine 

### if

### a SSEC would be appropriate. Actual 

### emissions"from the 

### sevendryers are 

### shown in 

### Exhibit3 ofthe 

### StatementofReasons 

### for this site-specific 

### amendment. In 

### accordance withUSEPA 

### guidance, the baseline emissions for BuildingAP16 

### were calculated to 

### be 22.9 tonlyr based 

### on the historical actual emissions from 

### the highest 2-yearperiod ofthepast 10 years. Thus, in orderto demonstrate environmental benefitas described in 

### the E1P

" " 

### guidance, 

### the total allowable combined emissions from the 

### seven dryers underthe

. 5

## ')

)

J 

### proposedSSECwouldneed to 

### be setat a:

### level 10percentlowerthan the calculated 

### baseline emissionS, 

### or20.6 ton/yr

### ofVOM. 

## Iil

j

## ~ciQlp'ari~on**~ith** this

## pr()~pecti;\re limit, the-c:\itTerit

### eoinbWed allowable YOM

### emis$ion,ritt~,**b~ed** on., 

### the

### ~ndiViduai**thr~h()lds** fo.r

### ~ch ofthe

# sevendryers, is 45 

### ton/Yr.'**AlthQ~~** 

### Abbott

## eqUid operate 

### atthis einissioillevel

## ifneeded for operations, its 

### historical acttial 

### emissions have consistgritiybeeillower

## than

# rue cU:i.tent

### combined allowable etmssions:forthe'seven dryers. Thus; the'currenra11owable combined emission 

### tate is higher

### than what.A.bbottis proposing under

### the amehded 

### site-specific standard.

, Abbottconsiders,-the'flexibility

### to shiftproduction among the
. .dryets to 

### be more

### important thanthe ability

### fO operate with currentmaximum ov:era11 

### emissions. Therefore, the

" principalrequirement for a SSEC under'the EIP, 

## acomhined 

### allowable emission

threshold lowerthanhistorical actual emissions, wouldbe an acceptable alternative to Abbott In 

### orderto 

### ensure that the 

### proposed site-specific amendmentto 35 Ill. Admin. 

### Code §218,480(h) is 

### co:gsistent**wit~,** 

### USEPA 

### guidfllice 

### regardip,g EIPs, and 

### to realize the 

### adininistrative be:pefit

# ora:programthat

### is,acc:epta1?le 

### to all prospectiveparties, the

.,: 

### progx:ammust'

## satisfY three fundamental 

### principles of 

### USEPA;s 

## EiP program: integrity, 

### equityand environmental 

### benefit. 'These are defined, E;m.d discussed:,i,n USEPA's ImprovingAir Qualitywith EconomicIncentive Program. See Exhibit 2, Statement of

, 

## . , Reasons
..-Consistency with eachofthese'three

### principles is discussed 

### separately below. Theprinciple ofintegrityconsists offourelements: emissions must be 

### surplus, 

### quantifiable, enforceable, andpermanent. Notethatthese terms have sp¢cific meanings, and are**differe~t** 

### for a SSEC thanfor otherprograms addressed'bythe

### policy. 

## id. at35. 6< , 

### , Electronic 

### Filing, wi 

### Received;**Clei'k~s** 

### Officej 

### Fti!br.uiiry,.22, 200'S



# • 

# •



# '.

.-

' 

### Emissions are ,surplusbecausethe baseline for the p:r;ospective'SSEqfor the seven dryers is based on thehistorical actual emissions forthese units, andbecause theprogram will reduce emissions belowthis baseline;,**Ewi$s~ons ar~** **qp.aI).ti,fi@Je'bp,ca'Q~e<th~ ~~lculati9.n**  

### ofbo.th,baseline emissions and

### fufui.-e eiriissions

## undertHeSSEc i$

## based'

# onamass balance fqr a**S9}.Y~~t evapQ~~ion**  

### p,rQCess with VOM among the materials 

### used. A**mass~Da1aD.ce** 

### calcUlation

### 'is

## "consideredto be 

### a

## veryreliable**me~odoJQgy** fQI:**ffil!m~fyip.g** 

### YOM**emi~sions** 

### on a,12-month average 

### basis. 

## The

## ii1etiibdofogyfor 

## quantifying emissions

# Iro-mflit' dryers is 

### alrea4Xwell 

### documented

## i9:**t~e** 

### facilitts CAAPP Pennit .- " 

### Emissions are 

### enforceable because the program is to be incorporated into 35'm. 

### Adnlin.Code Part 218, 

### approved by

### USEPA-as,partofillinois' State Implementation Plan for ozone attainment, and incorporated into the facility?'S DAAPP Permit as'an applicablerequirement. EnforCementwill 

### be based onthe same programthat is now in place inthe CAAPP Permit,**whereeniis~ions,** 

### aretracked by,mass-balance emission calculationsbased on productionrecords.

### Eniissi~~s are'permanentbecauSe the 

### site-specific amendmentto 35 TIL Admin. Code. J;>art

### ZI8 

### will**memoria1iz~** 

### the**cond~tions** 

### .

•••11 

### The principleofequityis evaluatedto ensurethattheEIPs program

## does not result in 

### "an uneven distribution ofemissions or'
... effects." Id. at46. This programis

, not ofconcernfor equity issues forthree reasons.

• This 

### program focuses**excJ~ively** 

### on YOM emissi<)Dsfrom oneparticular 

### facility. therefore, 

## there is no 

### concern for 

### impacts in 

### one area

## thatmust ' Qe**~al~~e~** 

### equitably withreductions**i~** 

### another area. 1n 

### a.dditiOIl; the EIP


## ,wilt**r~sUIt** 

### i'n loweremissions than'thehistoriC 

## actdal'emissions forthe UI1.its 

### inthe solearea ofimpact. Therefore, there will beno areaof increased environmental impactthat

### mustbe''balanced 

### against

# anoverall impactreduction. 

## In**concunence~** 

### USEPA guidance indicates that equity 

### isSUes aretypica11y'ncitofconcern

### for 

### it single-site 

## SSEC program. rd. at SQ. '



### • Emissions ofVOM

### have envil:onmental effects on aregional scalerather than alocalizedimpact. AISOt' 

### the**ove~ impa~t**  

### ofthe progt:am will be ' positive because both allowable and historical actual emissions will be 

### reduced. Theprinciple ofenvironmental benefitis 

### satisfied by the intention for the**prog~** 

### to reduce emissions 10percentbelowhistorical actual levels. While other 

### 7**de~onstrations** 

### ofbenefits may be appropriate.the lQ percentemissionreduction criteria is clearly defmed byUSEP 

### A as appropriate for demonstration ofenvironm.ental benefit 

### Id. at 

### 51. Illinois EPA 

### andUSEPA both agreed that Abbott's proposal metthe criteriafor 

## aSSECEIP. In 

### sturtInaiy,**th~** 

### prcposed sitewspecific amendmentwillresult in significant
. environmentalbenefits. 

### Maximum future 

### allowable emissions of20.6 tonlyr

### from the

. . 

### . seven dryers will be 10percentbelow the historical 

### actualemissions determined. by 

### USEPA criteria(22.9 tonlyr). 

### Future actual combinedemissions from 

### the sevendryers 

### will be well below whatis currently allowedfor theunits (45 tonlyr). Atthe same time, the proposed**site~specific** 

### amendment

### will provide increased

. . . . 

### operational efficiency and flexibility that

### will be valuable to 

### Abbott in addressing our· national and global competitors. As·importantly to the overall result, Abbotfs increased

. 

## . flexibility can be achieved withoutrelaxingthe stringency ofthe currentemission control thresholds. I would like to thankthe Board for itstime and attentionin considering our. proposal andmy testimony. I would 

### also like 

### to thank

### the Illinois EPA for working 

### with
. Abbottto identifY apractical site-specific amendmentfor**great~r** 

### regulatory efficiency. I wouldbe 

### happy to 

### answer 

### any questions.

) 

# '" *

8 

# *-or 

### Abbottreserves,the righHosupplement!ormodifythis 

### pre... iiredtestimony. 

### Respectfullysubmitted, , ABBOTTLABORATORIES,
By:/sf

### KatherineD; :Hodge, One ofits 

### Attorneys 

### Dated: February22, 2008 Katherine 1).: Hqdge 

### Lauten'C.J.Ji;'Urtifis HODGE DWYERZEMAN 3150 Roland

## Avenue Post OfficeBox 5776 Spfin'gf'ield, TIlinois**'62705~S776** 

### (217) 523-4900 ABOT:Ol>3IFilings/Wells Prefiled Testimony

- Final Draft



### 9 

# \

. \

f

, 

### ,

## ,... ILLINOIS POLLUTION CONTROL BOARD March 4, 2008 

## p-,.O!-E**~f.** 

### ..

# 'tff:~,~~~6 MAR - 42008 STATE 

### OF ILLINOIS 

### Pollution Control Board IN THE MATTER OF: ) ) ABBOTT LABORATORIES' PROPOSED ) SITE SPECIFIC AMENDMENT TO ) APPLICABILITY SECTION OF ORGANIC )
. MATERIAL EMISSION STANDARDS AND ) LIMITATIONS FOR THE CHICAGO AREA; ) SUBPART T: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b)) R08-8 (Rulemaking

- Air)



### HEARING OFFICER ORDER On September4, 2007, Abbott Laboratories (Abpott) filed a proposal for site-specific rulemaking pursuantto Section 28 ofEnvironniental ProtectionAct (Act) (415 ILCS 5/28 (2006)), to allow it "additional operational flexibility" withregard to emissions from certain tunnel dryers and fluid bed dryers atjts pharmaceutical manufacturing facility (the facility) located in Libertyville Township, Lake County. 

## ( "-... As explained in the January 31, 2008 hearing officer order, the·hearing in this rulemaking will be held in Libertyville onMarch 7, 2008, b.eginning 

### at 1:00p.m. Boththe technical justification and economic impact oftherules 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 February22, 2008, consistentwiththe hearing officer order, Abbottprefiled testimony ofDiane Beno and Robert C. Wells
.. The Illinois Environmental Protection Agency (Agency) has not prefiled any testimony. No other testimonyhas beenprefiled. In the. interest offacilitating the hearing process, the Board has reduced to writing questions it would like the participants to address athearing, and is making them**availabl~** to partidpants in advance ofhearing. These questions appear onpages 2-5 ofthis order. While some questions are addressed to partiCUlar witnesses, 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 onthe notice list for this proceeding.

# (

( 2 Questions on Proposal & 

### Pre-med Testimony Statement ofReasons 1. Onpage 3, the Statement ofReasons (SOR) states that the current YOM requirements at Section 218.480(b) arebased onthe provisions ofSection 215.480(b), which was adopted by the Board on April 7, 1988 in Docket R86-1 

### O. Further, the SOR states that during the rulemaking in R86-1 0 both the petitioner and IEPA "provided technical documentation and testimony to the effectthat certain emission sources, including tunnel dryers and fluid bed dryers, wouldbe economically infeasible to control at the levels required for certain other emission sources at the facility."

. a) Please comment onwhetherthe infonnation/testimonypresented inthe R86- 10 rulemaking regarding economic feasibility ofcontrolling emissions from Abbott's tunnel dryers and fluid bed dryers is still valid. b) Has there been in any development in emissions control technology sincethe adoption ofthe original rules that addresses the economic concerns associated with control ofemissions from the affected dryers? 2. On page 6, the SOR notes that the average actual emissions from the fluid bed'dryers and tunnel dryers for 1999 and 2000 were used to detennine the proposed combined emission limit of20.7 tons per year. (This was revised to 20.6 tons peryear in Abbott's February 29,2008 motion to amend.) According to Exhibit 3, total emissions from years 1999 and 2000 represent the highest actual emissions. Starting from 2001 and until 2007, the total actual emissions from the affected dryers are approximately halfthe total emissions in 1999 and 2000. Further, the YOM emissions data show a decliningtrend. a) Please explain the 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. Premed Testimony

- Diane Beno 1. Onpage 2, you state thatthe organic solvent currently used for massing fluid in AP-16 is ethanol. Please comment on whether Abbotthas used organic solvents other 

### than ethanol in the manufacture ofpharmaceuticals in the past. Ifso, please provide names ofother solvents used for massing fluid. 2. Please explain the basis for choosing the type ofsolventused for massing fluid, i.e. whether the'solvent type is mainly dependent on the productbeing manufactured orthe type ofsolvent is also dependent onthe type ofdryer being used in the process.

### 3 3. On page 

### 3, you state that Abbott has increased the use offluid dryers for recently developed products, and anticipates increased use of water for the massing fluid.

a. Please comment on whether Abbott anticipates increased use ofwater inproduct lines using both tunnel 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 that may result from increased use ofwater?

c. Please elaborate onwhy Abbot considers water-based products as a "preferential use". d. Please explainwhat role, ifany, pollutionprevention (PP) plays in increasjng the use ofwater for massing fluid in future products. Does Abbott have some-type of an in-house PP incentive program to reduce YOM emissions? Please elaborate on Abbott's PP activities as they may relate to the affected dryers. 4. Also on page 3, you note that increased use offluid dryers is mairily because they are more efficient and produce a more uniform productthan tunnel dryers.

a. Please explain how the fluid bed dryers are more efficientthan the tunnel dryers. b. Does Abbott have anyplans to 

### replace the tunnel dryers with fluid dryers? 5. Qnpage 4, you state that under the currentrules, Abbott maybe required to utilize a dryer with low YOM emissions during the last 12 months instead ofusing the dryerthat is most efficient from a production-scale standpointto ensure compliance with the current running i2-month total YOM limit on each dryer.

a. Please clarify what you meanby "using the dryer that is most efficient from a production-scale standpoint." b. Other than a dryer's previous 12-month YOM emissions, what factors are considered in deciding the type ofdryer used for a particular campaign? 

### PreiIled Testimony - Robert Wells 1. On 

### page 5, you state that under USEPA guidelines, ''historical actual emissions" are defined as the highest actual emissions from any 2-yearperiodwithin the last 10 years of operation. Please clarify whether the definition of"historical actual emissions" used in your testimony is based on the USEPA's Economic Incentive Program (EIP) guidelines. Ifnot, pleaseprovide a complete citation to the appropriate USEPA publication, which defines what constitutes historical actual emissions.\.... 4 2. The USEPA's ElP guidelines at pa,ge 166 defines**''historic~** actual emissions" as "actual emissions associated with a source in a time periodprior to the source's participation in ElP, usually representing the average emissions ofthe past tWo years or some othermore representative period:'



# .. a. Please explain why the baseline was not calculated on the basis ofaverage emissions ofthe past two years (2006 & 2007). b. lithe basis for using the average emissions from 1999 and 2000 is because that period is more representative, please explain whythat time period is considered representative. Particularly, since the emissions data indicate significantly lower emission during 2001 to 2005. USEP

### A's EconomicIncentive Program Guidance 1. Atpage 3, the EIP guidance states thatthe guidance applies ifa state or tribe wants to establish a discretionary EIP for attaining ormaintainingthe national ambient airquality s.tandards (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 statementimplythat the state should first adopt some type ofa discretionary ElP policybefore considering a request such as the one made by Abbott? b. Ifso, has the Agency adopted an Ell? policy for Illinois? !fnot, should this rulemaking be considered as the State's adoption ofthe EIP policy?

c. Please comment on whether Abbott's proposal is the first requestmade under the USEPA's EIP in lllinois. 2. At page 6, Mr. Wells states that in order to ensure that theproposed site-specific amendment is consistent withUSEPA ElP guidance, and to realize the administrative benefit ofa program, the program must satisfythree fundamental principles ofUSEPA's EIP program: integrity, equity and environmental benefit. Does the Agency believe that the proposed rule along with the supporting documentation satisfies the EIP principles?
. 3. At page 6 ofMr. Wells' testimony, 

### Mr. Wells states that the principle ofintegrity consists offour elements: emissions must be surplus, quantifiable, enforc.eable, and permanel1t. Furtherhe notes that these terms have specific meanings, and are different for a source specific emissions cap (SSEC) than for otherprograms addres.sed by the policy.

a. Please 

### clarify whether the 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 limitmay notbe consistent with the EIP guidance since the baseline is calculated on the basis ofhighest a,ctual emissions? Proposed Amendments 1. Abbott's proposal amends the existingrules at 35 Ill. Adm. Code 21S.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 whether the rules should specifically state that the YOM limits apply to dryers located at the Abbott Laboratories, Building AP16, especially since the proposed amendments at Section 218.4S0(b)(4) refer specifically to certain numbered fluid bed dryers, and tunnel dryers. Abbot's February 29, 2008 Motion to Amend This order does 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, at the close ofhearing, the hearing officer will set a date by which the record will close and all public comments mustbe submitted. See35 Ill. Adm. Code 102.1

## os. As the Board is awarethat Abbott would appreciate Board decisionmaking as soon as possible, the posthearing comment period will notbe lengthyunless lmanticipated circumstances dictate otherwise. IT IS SO ORDERED.

### 2

# ~h~~ Kathleen M. Crowley Hearing Officer, lllinois Pollution Control Board 100 WestRandolph Street, Suite 11-500 Chicago, lllinois 60601 (312) 814-6929 crowlek@ipcb.state.i1.ns3 

### EXHIBIT LIST 

## R08-8 Abbott Laboratories' Proposed Site-Specific Amendment to Applicability Section ofOrganic Material Emission Standards and Limitations for the Chicago Area: Subpart T: Pharmaceutical Manufacturing (35 Ill. Adm. Code 218.480(b))

Exhibits submitted at hearing March 7,2008 Exhibit 1 Exhibit 2

Exhibit 3
Exhibit 4
Exhibit 5

Exhibit 6 Aerial Photograph ofAbbottPark and Vicinity (single page) Improving Air Quality with Economic mcentive Programs, Doc. No.EPA452/ROI-00I, United States Environmental Protection Agency, Office ofAir and Radiation, Office ofAir Quality Planning and Standards (January 200I) Revised Exhibit 3 (2/29/08) "Historical VOM Air Emissions from Tunnel Dryers and Fluid Bed Dryers at the Abbott ParkFacility" (single page) Chart, "Granulation Process-Fluid Bed Drying" and "Granulation ProcessTunnel Drying" (single page) Pre-filed testimony ofRobert C. Wells, AirManager for Environmental Support, Abbott Laboratories Environmental Health and Safety Department (as filed with the Board February 22,2008) March 4, 2008 Hearing Officer Order in R08-8 containing "Questions onProposal and Pre-filed Testimony"4 CERTIFICATE OF SERVICE It is hereby certified that true copies ofthe foregoing orderwere mailed, first class, on March 28, 2008, to each ofthe persons on the attached service list. It is hereby certified that a true copy ofthe foregoing orderwas hand delivered to the following on March 28 2008: John T. Therriault Illinois Pollution Control Board James R. Thompson Center 100 W. Randolph St., Ste. 11-500 Chicago, Illinois 60601

# +<~ '»--,

# -~ :r6thleen M. Crowley Hearing Officer Illinois Pollution Control Board 1021 North Grand Avenue East P.O. Box 19274 Springfield, Illinois 62794-9274 312/814-6929 crowlek@ipcb.state.il.usR2008-008 Charles E. Matoesian IEPA 1021 North Grand Avenue East P.O. Box 19276 Springfield, IL 62794-9276

R2008-008 Katherine D. Hodge Hodge Dwyer Zeman 3150 Roland Avenue Post Office Box 5776 Springfield, IL 62705-5776

R2008-008 Matthew J. Dunn Office ofthe Attorney General Environmental Bureau North 69 West Washington Street, Suite 1800 Chicago, IL 60602

R2008-008 Kathleen M. Crowley Illinois Pollution Control Board 100 W. Randolph St. Suite 11-500 Chicago, IL 60601 

### 5

R2008-008 IEPA 1021 North Grand Avenue East P.O. Box 19276 Springfield, IL 62794-9276

R2008-008 Lauren C. Lurkins Hodge Dwyer Zeman 3150 Roland Avenue Post Office Box 5776 Springfield,'IL 62705-5776

R2008-008 Office ofLegal Services Illinois Department ofNatural Resources One Natural Resources Way Springfield, IL 62702-1271IEPA ATTACHMENT NO. 

# 11- Electronic Filing· Received, Clerk's Office, April 7, 2008 BEFORE THE ILLINOIS POLLUTION CONTROL BOARD 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)



### NOTICE OF FILING TO: Mr. John Therriault Kathleen M. Crowley Assistant Clerk ofthe Board Hearing Officer Illinois Pollution Control Board Illinois Pollution Control Board 100 West Randolph Street 100 West Randolph Street Suite 11-500 Suite 11-500 Chicago, Illinois 60601 Chicago, Illinois 60601 

### (VIA ELECTRONIC MAIL) (VIA U.S. MAIL) (PERSONS ON ATTACHED SERVICE LIST) PLEASE TAKE NOTICE that I have today filed with the Office ofthe Clerk of the Illinois Pollution Control Board 

### MOTION TO CORRECT TRANSCRIPT, a copy ofwhich is herewith served upon you. Respectfully submitted, By: 

### lsi Katherine D. Hodge Katherine D. Hodge Dated: April 7, 2008 Katherine D. Hodge Lauren C. Lurkins HODGE DWYER ZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900

THIS FILING SUBMITTED ON RECYCLED PAPER

### Electronic Filing - Received, Clerk's Office, April 7, 2008 CERTIFICATE OF SERVICE I, Katherine D. Hodge, the undersigned, hereby certify that I have served MOTION TO CORRECT TRANSCRIPT upon: Mr. Jolm Therriault Assistant Clerk ofthe Board Illinois Pollution Control Board 100 West Randolph Street Suite 11-500 Chicago, Illinois 6060I via electronic mail on April 7,2008; and upon: Kathleen M. Crowley Hearing Officer Illinois Pollution Control Board James R. Thompson Center 100 West Randolph 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 Bureau North Office ofthe Attorney General 69 West Washington Street, Suite 1800 Chicago, Illinois 60602
Office ofLegal Services Illinois Department ofNatural Resources One Natural Resources Way Springfield, Illinois 62702-1271

by depositing said document in the United States Mail, postage prepaid, in Springfield, Illinois on April 7, 2008.


### lsi Katherine D. Hodge Katherine D. Hodge
ABOT:003/FilingsINOF & COS, Mtn to Correct Transcript

### Electronic Filing· Received, Clerk's Office, April 7, 2008 BEFORE THE ILLINOIS POLLUTION CONTROL BOARD IN THE MATTER OF: ) ) ABBOTT LABORATORIES' PROPOSED ) SITE-SPECIFIC AMENDMENT TO ) APPLICABILITY SECTION OF ORGANIC ) MATERIAL EMISSION STANDARDS AND) LIMITATIONS FOR THE CHICAGO AREA; ) SUBPART T: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b» ) R08-8 (Rulemaking -Air)

MOTION TO CORRECT TRANSCRIPT NOW COMES ABBOTT LABORATORIES, by and through its attorneys, HODGE DWYER ZEMAN, and pursuant to 35 Ill. Admin. Code 

### § 101.604, requests that the Illinois Pollution Control Board ("Board") order the correction ofthe transcript ofthe hearing in this matter held on March 7, 2008, as follows: Page Line 1 17 3 4 3 8 3 10 4 12 6 9 6 13 9 14 11 4 11 22 13 5 14 10 18 9 19 1 21 II 23 12 25 5 26 2 26 9 26 11 27 11 Correction Change "8" to "1" Change "Abbott Laboratories" to "Abbott Laboratories'" Insert "Area" after "Chicago" Change "218.408(b)" to "218.480(b)" Change "rule making" to "rulemaking" Change "Zeeman" to "Zeman" Change "hearing" to "hear" Change "apply" to "applies" Change "effected" to "affected" Change "Program" to "Programs" Change "EIP's" to "EIPs" Change "EPA-452/R-0 1-00 1" to "EPA-452/RO 1-00 1" Change "Granulation Process Fluid Bed Drawing" to "Granulation Process

- Fluid Bed Drying" Change "air" to "bed" Insert "and" after "months" Change "results" to "result" Change "parking" to "Park" Change "where" to "year" Change "effected" to "affected" Change "One be would be to" to "One would be to" Change "Zeeman" to "Zeman"

### Electronic Filing - Received, Clerkls Office, April 7, 2008
28 29 31 31 32 32 35 36 43 43 43 44 45 45 46 46 46 50 50 15 14

8 20 10 22 15 15 9 13 23 23

2 4 20 21 22

9 16 Change "insure" to "ensure" Change "record keeping" to "recordkeeping" Change "Exhibit 8" to "Exhibit 6" Change "rule making" to "rulemaking" Change "rule making" to "rulemaking" Change "over" to "after" Change "tunnel dryer three" to "tunnel dryer four" Insert "of' after "some" Change "technology. Meaning" to "technology, meaning" Change "batch, and then" to "batch. And then" Change "ethanol, use not" to "ethanol use, not" Delete the comma after "guidelines" Delete the comma after "review" Change "that is ," to "that is," Change "PSR" to "PSD" Change "80.186" to "80186" Change "We" to "Well" Change the period to a question mark Change "28.480(b)" to "218.480(b)" WHEREFORE, for the reasons set forth above, ABBOTT LABORATORIES respectfully requests that the Board order the correction ofthe hearing transcript as set forth above. Respectfully submitted, ABBOTT LABORATORIES, By: 

### lsi Katherine D. Hodge One ofits Attorneys Dated: April 7, 2008 Katherine D. Hodge Lauren C. Lurkins HODGE DWYER ZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003fFilings/Motion to Correct Transcript

2rEPA ATIACHMENT NO 

## I

# 3 Electronic filing. Received, Clerk"s Office, May 1, 2008 '- 

### * * * <j 

### * PC #1 

### * * * * *
BEFORE THE ILLINOIS POLLUTION CONTROL BOARD
IN THE MATTER OF: ABBOTT LABORATORIES' PROPOSED SITE-SPECIFIC AMENDMENT TO APPLICABILITY SECTION OF ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS FOR THE CmCAGO AREA; SUBPART T: PHARMACEUTICAL MANUFACTURING (35 ILL. ADM. CODE 218.480(b»


### NOTICE TO: John Therriault, Assistant Clerk Illinois Pollution Control Board State ofIllinois Center 100 West Randolph, Suite 11-500 Chicago, Illinois 60601 SEE ATTACHED SERVICE LIST ) ) ) ) ) ) ) ) ) ) R08-8 

### (Rulemaking

- Air)

PLEASE TAKE NOTICE that I have today filed with the Office ofthe Pollution Control Board the attached POST-HEARING COMMENTS ofthe Illinois Environmental Protection Agency a copy ofwhich is herewith served upon you. ILLINOIS ENVIRONMENTAL PROTECTION AGENCY By:

_ Charles E. Matoesian Assistant Counsel Division ofLegal Counsel DATED: May 1,2008 1021 North Grand Ave. East P.O. Box 19276 Springfield, Illinois 62794-9276 (217) 782-5544Electronic filing· Received, Clerk's Office, 

### May 1, 2008 

## * * * * * PC #1 

## * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD
IN THE MATTER OF: ABBOTT LABORATORIES' PROPOSED SITE-SPECIFIC AMENDMENT TO APPLICABILITY SECTION OF ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS FOR THE CHICAGO AREA; SUBPART T: PHARMACEUTICAL MANUFACTURING (35 ILL. ADM. CODE 218.480(b» ) ) ) ) ) ) ) ) ) ) R08-8 

### (Rulemaking

- Air)

POST-HEARING COMMENTS OF THE ILLINOIS ENVIRONMENTAL PROTECTION AGENCY NOW COMES the ILLINOIS ENVIRONMENTAL PROTECTION AGENCY ("Illinois EPA"), by one ofits attorneys, and hereby submits its post-hearing comments in the above rulemaking proceeding. The Illinois EPA reviewed Abbott Laboratories' ("Abbott") petition filed with the Illinois Pollution Control Board ("Board") to amend Subpart T: Pharmaceutical Manufacturing (35 Ill. Adm. Code 218.480(b». Abbott proposed a source-specific cap on emissions ofvolatile organic material ("VOM") from its combined fluid bed dryers and tunnel dyers 

### in lieu ofrate-based limits provided in Section 218.480(b). The net effect ofthe proposal will result in a reduction of24.5 tons per year ofVOM emissions. The Illinois EPA has determined that the proposal will not adversely affect the air quality in Illinois. The Illinois EPA further consulted the United States Environmental Protection Agency ("USEPA") and concluded that the proposal is consistent with the guidelines of USEPA's Economic Incentive Program. Accordingly, after reviewing Abbott's petition, the Illinois EPA supports the requested site-specific relief.Electronic filing· Received, Clerk"s Office, May 1, 2008 

### * * * * * PC #1 

### * * * * *

Respectfully submitted, ILLINOIS ENVIRONMENTAL PROTECTION AGENCY By: Charles E. Matoesian Assistant Counsel Division ofLegal Counsel

DATED: 1021 North Grand Avenue, East P.O. Box 19276 Springfield, Illinois 62794-9276 217.782.5544 217.782.9807 (Fax)

2Electronic filing - Received, Clerk"s Office, May 1, 2008 

## * * * * * PC #1 

## * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD
STATE OF ILLINOIS COUNTY OF SANGAMON ) ) ) ) 

### SS

CERTIFICATE OF SERVICE I, the undersigned, an attorney, state that I have served electronically the attached POST-HEARING COMMENTS ofthe Illinois Environmental Protection Agency upon the following person: John Therriault, Acting Clerk Illinois Pollution Control Board State ofIllinois Center 100 West Randolph, Suite 11-500 Chicago, Illinois 60601 and mailing it by first class mail from Springfield, Illinois, with sufficient postage affixed to the following persons: SEE ATTACHED SERVICE LIST ILLINOIS ENVIRONMENTAL PROTECTION AGENCY

Charles E. Matoesian Assistant Counsel Division ofLegal Counsel
Dated: May 1, 2008 1021 North Grand Ave. East P.O. Box 19276 Springfield, Illinois 62794-9276 (217) 782-5544Electronic filing· Received, Clerk"s Office, May 1, 2008 

## * * * * * PC #1 

### * * * * *

BEFORE THE ILLINOIS POLLUTION CONTROL BOARD
IN THE MATTER OF: ABBOTT LABORATORIES' PROPOSED SITE-SPECIFIC AMENDMENT TO APPLICABILITY SECTION OF ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS FOR THE CHICAGO AREA; SUBPART T: PHARMACEUTICAL MANUFACTURING (35 ILL. ADM. CODE 218.480(b»
SERVICE LIST ) ) ) ) ) ) ) ) ) ) R08-8 (Rulemaking - Air)

Kathleen M. Crowley, Hearing Officer Illinois Pollution Control Board State ofIllinois Center 100 West Randolph, Suite 11-500 Chicago, Illinois 60601
Matthew J. Dunn, Chief Office ofAttorney General Environmental Bureau 69 W. Washington St., Suite 1800 Chicago, 

### IL 60602 Virginia I. Yang Illinois Department ofNatural Resources Office ofLegal Counsel One Natural Resources Way Springfield, 

### IL 62702-1271
Katherine D. Hodge Lauren C. Lurkins Hodge Dwyer & Zeman 215 E. Adams St. Springfield, 

### IL 62701Electronic Filing • Received, Clerk"s Office, May 1, 200IR:PA ATTACHMENT NO. 

# /4

* * * * * PC 2 

## * * * * * - BEFORE THE ILLINOIS POLLUTION CONTROL BOARD 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)

NOTICE OF FILING TO: Mr. Jolm Therriault Kathleen M. Crowley, Esq. Assistant Clerk ofthe Board Hearing Officer Illinois Pollution Control Board Illinois Pollution Control Board 100 West Randolph Street 100 West Randolph Street Suite 11-500 Suite 11-500 Chicago, Illinois 60601 Chicago, Illinois 60601 (VIA ELECTRONIC MAIL) (VIA U.S. MAIL) (PERSONS ON ATTACHED SERVICE LIST) PLEASE TAKE NOTICE that I have today filed with the Office ofthe Clerk of the Illinois Pollution Control Board ABBOTT LABORATORIES' POST-HEARING COMMENTS, a copy ofwhich is herewith served upon you. Respectfully submitted, By: /s/ Katherine D. Hodge Katherine D. Hodge Dated: May 1, 2008 Katherine D. Hodge Lauren C. Lurkins HODGE DWYERZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900

THIS FILING SUBMITTED ON RECYCLED PAPERElectronic Filing • Received, Clerk's Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * CERTIFICATE OF SERVICE I, Katherine D. Hodge, the undersigned, hereby certify that I have served ABBOTT LABORATORIES' POST-HEARING COMMENTS 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 May 1,2008; and upon: Kathleen M. Crowley, Esq. Hearing Officer Illinois Pollution Control Board 100 West Randolph 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, Esq. Chief Environmental Bureau North Office ofthe Attorney General 69 West Washington Street, Suite 1800 Chicago, Illinois 60602 Office ofLegal Services Illinois Department ofNatural Resources One Natural Resources Way Springfield, Illinois 62702-1271

by depositing said document in the United States Mail, postage prepaid, in Springfield, Illinois on May 1,2008.
/s/ Katherine D. Hodge Katherine D. Hodge
ABOT:003/FilingsINOF & cos, Post-Hearing CommentsElectronic Filing - Received, Clerk"s Office, May 1, 2008 

## * * * * * PC 2 

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

### ) ABBOTT LABORATORIES' PROPOSED ) SITE-SPECIFIC AMENDMENT TO ) APPLICABILITY SECTION OF ORGANIC ) MATERIAL EMISSION STANDARDS AND ) LIMITATIONS FOR THE CHICAGO AREA; ) SUBPART T: PHARMACEUTICAL ) MANUFACTURING (35 ILL. ADM. CODE ) 218.480(b» ) R08-8 (Rulemaking -Air)

ABBOTT LABORATORIES' POST-HEARING COMMENTS NOW COMES ABBOTT LABORATORIES ("Abbott"), by and through its attorneys, HODGE DWYER ZEMAN, and hereby provides the Illinois Pollution Control Board ("Board") with the following post-hearing comments. I. BACKGROUND On September 4, 2007, Abbott submitted to the Board a proposed site-specific amendment to 35 Ill. Admin. Code 

### § 218.480(b) ("Section 218.480(b)") pursuant to Sections 27 and 28 ofthe Illinois Environmental Protection Act ("Act") (415 ILCS 27 and 28),35 Ill. Admin. Code 

### § 102.210 and 35 Ill. Admin. Code 

### § 102.202(b) to allow it "additional operational flexibility" with regard to emissions from certain tunnel dyers and fluid bed dyers at its pharmaceutical manufacturing facility located in Libertyville Township, Lake County, Illinois ("Facility"). As part ofits initial filing, Abbott also submitted motions requesting the Board to waive the requirement for 200 signatures on its proposal and to expedite consideration ofits request by, among other things, ordering immediate publication ofthe rules for first notice under the Illinois Administrative Procedure Act ("APA") (5 ILCS 100/1-1).Electronic Filing· Received, Clerk"s Office, May 1, 2008 

## * * * * * PC 2 

## * * * * * On October 4,2007, the Board issued its First Notice Opinion and Order accepting the proposal for hearing and granting Abbott's Motion to Waive Requirement to Submit 200 Signatures. 

### In the same Opinion and Order, the Board denied Abbott's Motion for Expedited Review, but authorized first-notice publication without comment
on the merits ofthe proposal. On February 22, 2008, Abbott submitted the Prefiled Testimony ofDiane Beno in Support ofProposed Site-Specific Amendment and the Prefiled Testimony ofRobert C. Wells in Support ofProposed Site-Specific Amendment. On Februl;lry 29,2008, Abbott filed its Motion to File Revised Exhibit 3 and Minor Revision to Proposed Subsection 218.480(b)(4), in which Abbott sought to make the following changes to Exhibit 3 1 that

was submitted with the proposal: 1) correct a typographical error for the 1999 total, changing 26.1 to 25.1; 2) show single-unit data at 2 decimal places; 3) add a line for 90% ofthe baseline, with the corrected value of20.6 tons per year; 4) add Note c to identify the round-offissue and specify that totals are correct based on calculations with more significant figures; and 5) update the reference in Note a to reflect the correct condition in the renewed Clean Air Act Permit Program ("CAAPP") Permit, issued on September 26, 2007. Abbott also soughtto file a minor revision to its proposed amendment Section 218.480(b) to reflect the change made to the 90% baseline calculations, as follows:

I Please note that one additional clarification may be needed for the revised Exhibit 3. Specifically, upon compilation ofthe emission calculation data requested by USEPA and Illinois EPA after the hearing in this matter, it was noted that one small run with YOM emissions was conducted in fluid bed dryer# 3 in July of 1999. This run resulted in 0.0326 tons (65 pounds) ofVOM emissions. These emissions were not included in the revised Exhibit 3 due to the rounding ofvalues in the original Exhibit. The additional 65 pounds of emissions do not change the indicated tota11999 emissions, the 2-year emission total, or proposed combined limit for the seven dryers (90 percent ofbaseline), which are each stated to the nearest0.1 ton per year in revised Exhibit 3. 2Electronic Filing· Received, Clerk's Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * 

## 11 For fluid bed dryers #1, #2, and #3 and for tunnel dryers #1, #2, #3 and 

### #4, the combined total annual emissions from the dryers listed in this subsection 218.480(b)(4) shall not exceed 18 779 18,688 kg/year**(~** 20.6 tons/year). [BOARD NOTE: tunnel dryers are otherwise referred to as wann air dryers]; and



## * ** A hearing was held in Libertyville on March 7, 2008 ("Hearing"), with representatives ofboth the illinois Environmental Protection Agency ("Illinois EPA") and Abbott in attendance. II. THE PROPOSAL As explained more fully in Abbott's proposal and at the Hearing, Abbottproduces

numerous pharmaceutical products at the Facility, and these operations are subject to 35 Ill. Admin. Code Subpart T

- Pharmaceutical Manufacturing ("Subpart T"). As currently written, Section 218.480(b) ofSubpart T contains certain exemptions that are only applicable to Abbott's air suspension coater/dryer, fluid bed dryers, tunnel dryers and Accelacotas located at the Facility. Abbott is proposing to amend these site-specific exemptions by lowering the overall emissions allowable under the exemptions from its tunnel dryers numbered #1, #2, #3 and #4, and fluid bed dryers numbered #1, #2 and #3, and calculating the amount ofexempted emissions from these dryers based on their actual combined emissions. Ifadopted, the proposed amendment would reduce the overall allowable emissions from these units while increasing Abbott's operational flexibility with regard to these units. III. DISCUSSION The following information was presented at Hearing in directtestimony and in response to questions ofthe Board. Abbott presented two witnesses: Diane Beno, the 3Electronic Filing· Received, Clerk"s Office, May 1, 2008 

## * * * * * PC 2 

## * * * * * plant manager at Abbott's Building AP16; and Robert C. Wells, Air Manager for Environmental Support in Abbott's Global Environmental Health & Safety Department. Illinois EPA presented one witness: Yoginder Mahajan, an Engineer with the Air Quality Planning Section ofthe Illinois EPA Bureau ofAir. 

### A. Facility Process and Affected Emission Units In Building AP16 at the Facility, Abbott produces intermediate and final pharmaceutical product fonuulations. Pre-Filed Testimony ofDiane Beno ("Beno") at 1. Abbott manufactures its products using batch production processes. Beno at 

### 2. 

### In batch production, all ofthe processing equipment in a process train, including the dryers, manufactures one product at a time. Beno at 

### 2. In a typical process, the active and inactive ingredients are combined with a liquid in a process called "massing." Beno at 2. This massing process fonus uniform granules. Beno at 2. The wet granules are dried in tunnel dryers or fluid bed dryers and then further processed into tablets or capsules. Beno at 2. The massing fluid, which is typically either water or ethanol, is evaporated from the solid material in the drying step. Beno at 

### 2. Ifan organic solvent is volatilized from the dryer, it is emitted to the ambient air as volatile organic material ("VOM") or volatile organic compounds. Beno at 2. The quantity ofVOM emissions will vary for different products, and is calculated from the quantity ofVOM added to the mixture and loss factors defined for the dryers and specified in the CAAPP Permit for the Facility. Beno at 2. As stated above, Abbott's proposed site-specific amendment covers four tunnel dryers and three fluid bed dryers. Beno at 3. In the use oftunnel dryers, materials to be 

### 4Electronic Filing· Received, Clerk"s Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * dried are spread on trays and placed in a wanning chamber or "tunnel" that circulates

wann air over and under the trays. Beno at 3. A fluid bed dryer is a large vertical cylindrical shaped vessel with a diffuserthat blows warm air up from the bottom ofthe vessel. Beno at 3. The wet intennediate granules are loaded into the dryer and flow upward, suspended in the wann air stream. Beno at 3. Abbott has increased its use offluid bed dryers for recently developed products because they are more efficient and produce a more uniform product than the tunnel dryers. Beno at 3. Abbott anticipates increased use ofwater for the massing fluid in future products. Beno at 3. Abbott expects that this preferential use offluid bed dryers and water-based products will continue. Beno at 3. Batches ofspecific 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. Beno at 3. Individual dryers ofthe 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. Beno at 3-4. Process trains are designed to accommodate batches ofdifferent scales, with some for large batches and others for small batches. Beno at 4. Therefore, the scale ofa given batch plays an important role in detennining which ofthe dryers will be most efficient. Beno at 4. Additionally, extensive equipment cleaning is required between batches of different products, resulting in up to three days oflost production time. Beno at 4. Therefore, Abbott uses a campaign strategy to continue running batches ofthe same product consecutively in the process train to minimize this cleaning time. Beno at 4. 5Electronic Filing • Received, Clerk"s Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * As currently written, Section 218.480(b) effectively defines a 12-month total YOM limit on each individual dryer. Beno at 4. To ensure compliance with the current running 12-month total YOM limit on each dryer, for a particular batch, Abbott may be required to utilize a dryer with low YOM emissions during the last 12 months instead of using the dryer that is the most efficient from a production-scale standpoint. Beno at 4. Additionally, the dryer selected for a given campaign also depends on dryer availability and other factors. Beno at 4-5. Therefore, the standards, as currently defined, can result in wasted resources by requiring Abbott to dry a small batch ofproduct in our large-scale process train to maintain our equipment-specific YOM limits. Beno at 5. Total annual emissions from a dryer result from the quantity oforganic solvent removed from the differentproducts processed in a dryer over a rolling 12-month period. Beno at 5. The assignment ofa campaign ofa particularproduct to one or more dryers involves a number ofoperating factors, such as scale and equipment availability, that contribute to the efficiency ofmanufacturing. Beno at 5. The YOM emission threshold effectively acts as an overriding factor that can force a particularproduction campaign with YOM emissions to be scheduled using equipment that has low enough recent emissions to avoid exceeding a dryer threshold, but that may not otherwise be the optimal

or most efficient equipment for the campaign. Beno at 5. This scheduling shift increases the operational cost, but results in no environmental benefit, because the actual emissions will be the same as ifthe campaign would have used the optimal equipment. Beno at 5. In order to ensure Abbott's Facilityremains competitive with its national and global competitors, Abbott must continually seek ways ofmaking its manufacturing operations more efficient. Beno at 5. The scheduling inefficiency created by SubpartT 

### 6Electronic Filing· Received, Clerk"s Office, May 1, 2008 

### * * * * * PC 2 

### * * * * *

was identifi.ed as one area where improvements in efficiency could be made and is the basis for the proposed amendment. Beno at 5. The most efficient method to manufacture Abbott's products in Building AP16 would be to use the dryer that is best suited to the requirements ofthe production schedule and scale, regardless ofthe amount ofYOM that has been emitted from that dryer in the past 12 months. Beno at 6. Provided that the combined YOM emissions from all ofthe dryers are less than the combined amount allowed under Section 218.480(b), this method ofoperation would not require an increase in allowable YOM emissions from the Facility. Beno at 6. 

### In fact, the proposed amendment wouldprovide Abbott improved production flexibility to utilize the most efficient dryers for a given product, while significantly lowering the total allowed YOM emissions from all the dryers combined. Beno at 6. 

### B. Applicable Requirements and Actual Emissions Subpart T requires YOM controls for tunnel dryers and fluid bed dryers ifthe annual emissions exceed 7.5 tons per year ("ton/yr") for a tunnel dryer or 5 ton/yr for a fluid bed dryer. Hearing Transcript ("Tr.") at 25. The four tunnel dryers and three fluid bed dryers at issue in this proceeding, therefore, have total potential emissions without control of45 ton/yr. Tr. at 25. Because ofthe cost associated with YOM control for this type ofequipment, it is impractical to add control. Tr. at 25. Thus, the limits applicable before control is required effectively act as upper limits on the air emissions from the

seven dryers. Tr. at 25. The actual emissions from the seven dryers vary year to year based on the quantity ofproduction and the different materials produced. Tr. at 25. 

### In recent years, Abbott's tunnel dryer emissions have varied from 0.6 ton/yr to 5.6 ton/yr 

### 7Electronic Filing· Received, Clerk's Office, May 1, 2008 

## * * * * * PC 2 

## * * * * * each year. Tr. at 25-26. Fluid bed dryer emissions have varied from 0.1 ton/yr to 3.9 ton/yr each year the dryers have been operating. Tr. at 26. 

### C. Economic Incentive Program Abbott discussed alternative solutions to eliminate manufacturing constraints that affected the efficiency ofthe overall operation with Illinois EPA and USEPA. Tr. at 27. Illinois EPA and USEPA identified an alternative that was preferable to them called a Source Specific Emissions Cap ("SSEC") Economic Incentive Program ("ErP"), as identified in the USEPA Office ofAir and Radiation's EIP guidance document entitled Improving Air Quality with Economic Incentive Programs, Doc. No. EPA-452/ROI-001 (January 2001). Tr. at 27. The SSEC would allow Abbott to combine its future emission limits for all the dryers and establish a limit below the historical actual emissions, rather than the previously allowable emissions or emissions allowable without control. Tr. at 27. Under such an approach, the historical emissions would be based on a concept called "baseline actual emissions," which is defined as the highest two-year period in the preceding ten-yearperiod. Tr. at 27-28. Abbott reviewed the actual emissions from the dryers in the most recent ten years and identified the maximum two-year period with emissions of22.9 ton/yr in 1999 and 2000. Tr. at 28. That amount was then reduced by ten percent to ensure environmental benefit and resulted in an emission limit of20.6 ton/yr for the seven dryers. Tr. at 28. This emissions limit would be less than halfofthe 45 ton/yr effective limit that now applies to the seven dryers taken together. Tr. at 28. The significantly lower allowable limit is acceptable to Abbott's anticipated business and meets its flexibility needs. Tr. at 28.



### 8Electronic Filing· Received, Clerk"s Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * In going forward with the SSEC EIP approach, Abbott considered its confonnance with the three general principles ofan EIP: 1) integrity; 2) equity; and 3) environmental benefit. Tr. at 28-29. Abbott is confident that its proposal satisfies all of the general ElP principles. Tr. at 29-30. 

### D. Questions ofthe Board Addressed at Hearing No members ofthe public attended the Hearing. Tr. at 4. At the Hearing, the Hearing Officer asked Abbott to address the questions ofthe Board that were included in the Hearing Officer Order ofMarch 4, 2008. Tr. at 31. In response to those questions, the following testimony was provided by Abbott for the Board's consideration. The Board's Statement ofReasons Question 1(a) referred to whether the infomlation presented in the R86-1 0 rulemaking regarding economic feasibility of controlling emissions from Abbott's tunnel dryers and fluid bed dryers is still valid. In response, Mr. Wells stated that it is. Tr. at 31. As part ofthe rulemaking process, Abbott analyzed the cost ofcontrol using a methodology developed by USEPA for theBest Available Control Technology ("BACT") analysis. Tr. at 32. Using the BACT analysis, Abbott found that the cost ofcontrol continued to be significantly in excess ofwhat is nonnally considered Reasonably Available Control Technology. Tr. at 32. Essentially, the economics have not changed since the R86-10 rulemaking. Tr. at 32. Statement ofReasons Question l(b) asked whether there has been any development in emissions control technology since the adoption ofthe original rules. 

### In response, Mr. Wells stated that there have been no fundamental changes in emission control technology that would be applicable to the Facility since the original rulemaking.

9Electronic Filing· Received, Clerk's Office, May 1, 2008 

## * * * * * PC 2 

## * * * * * Tr. at 32. Therefore, Abbott considered the same control technologies that were considered at the time ofthe original rulemaking. Tr. at 32. Statement ofReasons Question 2(a) asked about the reasons for the significantly lower actual emissions from Abbott's dryers since year 2000. 

### In response, Ms. Beno stated that pharmaceutical manufacturing business activity is highly variable year after year. Tr. at 32. The types ofproducts Abbottproduces in a given year can varybased on
a number ofmarket factors and patient demand. Tr. at 32-33. Different products emit different levels ofVOM, and product mix is a primary factor regarding the variability of Abbott's emissions. Tr. at 33. Additionally, new products that have been introduced to the Facility typically have used water-based solvents, and there is no YOM produced when water is used as a massing fluid. Tr. at 33. Abbott also does not expect emissions to increase over time. Tr. at 33. Statement ofReasons Question 2(b) asked whether Abbott has stopped operating dryer #4. In response, Ms. Beno stated that tunnel dryer #4 has not been in use since 2005. Tr. at 35. However, it remains fully validated, maintained and available for use shouldproduction needs demand. Tr. at 35. Beno Prefiled Testimony Question 1 asked whether Abbott has used organic solvents other than ethanol in the manufacture ofpharmaceuticals in the past. 

### In response, Ms. Beno stated that ethanol has been the only organic massing fluid used by Abbott in Building AB 16 during the ten-year period under review for the proposal. Tr. at 37. In late 2002, however, the type ofethanol used was denatured ethanol, which contains a small percentage ofmethanol as the denaturant. Tr. at 38. Since late 2002,

10Electronic Filing· Received, Clerk"s Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * Abbott has converted to all beverage grade ethanol which does not contain methanol as the denaturant. Tr. at 38. Beno Prefiled Testimony Question 2 asked for explanation ofthe basis for choosing the type ofsolvent used as massing fluid by Abbott. 

### In response, Ms. Beno stated that the choice ofmassing fluid is dependent on the particular properties ofa product, not whether or not water is an option. Tr. at 38. The type ofdryer used also has nothing to do with the choice ofsolvent. Tr. at 38-39. Water or ethanol can be used in either drying technology. Tr. at 39. Beno Prefiled Testimony Question 3(a) asked for comment on whether Abbott anticipates increased use ofwater in product lines using both tunnel dryers and fluid bed dryers. In response, Ms. Beno stated that Abbott does expect there to be an increased use ofwater in new products. Tr. at 39. However, it is not practical to change the ethanolbased processes to water-based processes because ofUnited States Food and Drug Administration ("FDA") considerations. Tr. at 39. Abbott considers the type ofmassing fluid as it develops new products, with a preference to use water. Tr. at 39. Beno Prefiled Testimony Question 3(b) asked whether the anticipated increase in

use ofwater for massing fluid is intended to reduce YOM emissions. 

### In response, Ms. Beno stated that YOM emission avoidance is one ofseveral factors consideredby Abbott

as the benefits resulting from increased use ofwater for the massing fluid. Tr. at 39-40. Otherbenefits include increased raw material costs, reduced worker exposure to organic materials in the workplace, and improved safety due to reduction offlammable solvents. Tr. at 40.

11Electronic Filing· Received, Clerk"s Office, May 1, 2008 

## * * * * * PC 2 

### * * * * * Beno Prefiled Testimony Question 3(c) asked why Abbott considers water-based products a "preferential use." In response, Ms. Beno stated that water-based products are preferable for anumber ofreasons. Tr. at 40. They are preferable because they do not contribute to YOM emissions, reduced raw material costs, reduced worker exposure, and improved overall safety to the facility. Tr. at 40. Beno Prefiled Testimony Question 4(a) asked how the fluid bed dryers are more efficient than the tunnel dryers. In response, Ms. Beno stated that fluid bed dryers are
more efficient mainly due to their operation. Tr. at 40. In a fluid bed dryer, individual granules ofproduct are airborne in the warm air stream and the air moves freely on all surfaces ofthe granule in the drying process. Tr. at 40. This results in amuchmore even drying process and higher quality end-product because ofthe evenness ofthe drying. Tr. at 41. Tunnel dryers, on the other hand, are similar to cookie sheets in an oven. Tr. at 41. Material is hand-loaded onto the sheet and onto a large rack. Tr. at 41. The rack is then pushed into the tunnel dryer and is exposed to air movement in the tunnel. Tr. at 41. The result in a tunnel dryer is similar to that found in baking: some parts ofthe product are
more done that otherparts. Tr. at 41. Whereas in the fluid bed drying technology, more ofthe product or granules are exposed to the warm air across the entire surface, making for amuch more uniform drying process. 2 

### Beno Prefiled Testimony Question 4(b) asked whether Abbotthas anyplans to replace the tunnel dryers with fluid bed dryers. In 

### response, Ms. Beno stated that Abbott does not expect to phase outtunnel drying equipment or concentrate on purchasing new

2This is a correction from the Hearing Transcript at 41. 

### 12Electronic Filing· Received, Clerk"s Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * fluid drying equipment because switching technologies can have an impact on the safety and efficacy ofa drug product and involve the FDA. Tr. at 34. Beno Prefiled Testimony Question 5(a) asked what was meant by "using the dryer that is most efficient from a production-scale standpoint." ill response, Ms. Beno pointed out that one example ofthe inefficiencies created by the currentrule is that the most appropriately sized equipment may not be chosen. Tr. at 41. ill the event that the smallscale process train would be approaching its limit, Abbott may be forced to use the largescale process train to process smaller batches than would normally be processed in that process train. Tr. at 42. In such a situation, the full capacity ofthe equipment would not be utilized. Tr. at 42. Beno Prefiled Testimony Question 5(b) asked for factors, other than a dryer's previous 12-month YOM emissions, that are considered in deciding the type ofdryer to
use for a particular campaign. In response, Ms. Beno stated that technology is considered first when making such a selection. Tr. at 43. As noted above, a product can be produced eitherby a tunnel dryer or a fluid bed dryer, not a combination. Tr. at 43. The second consideration is scale, meaning whether it is a small-scale batch or a large-scale batch. Tr. at 43. The third consideration is general availability, meaning whether Abbott has more products running in a certain scale or ifone is down for maintenance or cleaning. Tr. at 43. Wells Prefiled Testimony Questions 1 asked about whether the definition of "historical actual emissions" used in Mr. Wells' prefiled testimony is based on USEPA's EIP guidelines. Wells Prefiled Testimony Question 2(a) asked why the baseline was not calculated based on the average emissions ofthe past two years. Wells Prefiled 

### 13Electronic Filing. Received, Clerk"s Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * Testimony Question 2(b) asked why emissions from 1999 and 2000 were considered representative. 

### In response to these questions, Mr. Wells stated that there has been a change in the philosophy on the conceptual level in USEPA's application ofhistorical emissions. Tr. at 44. The definition of"historical actual emissions" that appears in the 2001 guidelines developed by USEPA is the same as the concept in the Prevention of Significant Deterioration ("PSD") or non-attainment New Source Review ("NSR") netting that USEPA has previously used and was in place at that time. Tr. at 44-45. That definition of"historical actual emissions" referred to the two years immediately preceding the action or another two-year period, ifit could be determined more representative. Tr. at 45. Historically, there were a number ofproblems with determining whether a particularperiod was representative, so USEPA changed the definition ofactual emissions in 2002. Tr. at 45. At that time, USEPA defined a term called "baseline actual emissions" for the PSD and NSR program that allowed the use of any 24-month period during the preceding 10 years. Tr. at 45. The new definition

assures that a facility can look back far enough to find a representative business cycle so that it can locate periods when normal fluctuation ofbusiness would result in relatively higher emissions. Tr. at 45. Illinois EPA and USEPA recommended this new interpretation to Abbott. Tr. at 45-46. The baseline actual emissions were established in

a Federal Register notice amending the PSD rules at 67 Fed. Reg. 80,186. Tr. at 46. Even though the YOM emissions from 1999 and 2000 are at least twice as much as the emissions from the next five years, Abbott chose 1999 and 2000 as representative because if

### it were to experience the same demand it did during those years and ifit would have to use the same drying system or massing fluid, it would want to be able to fulfill 14Electronic Filing - Received, Clerk's Office, May 1, 2008 

## * * * * * PC 2 

## * * * * *
the demand. Tr. at 47. Additionally, Abbott reduced the historical baseline from 1999 and 2000 by ten percent. Tr. at 47. Overall, ifAbbott ran all its dryers at capacity, it would produce 45 ton/yr, and the proposed regulatory reliefwould reduce thatby more than half. Tr. at 47-48. Proposed Amendment Question 1 asked whether the rules at Section 218.480(b) should state thatthe YOM limits apply to dryers located at the Abbott Laboratories, Building API6, since the proposed amendments to Section 218.480(b)(4) refer specifically to certain numbered fluid bed dryers and tunnel dryers. In response, Mr. Wells stated that Abbott's concern with the specification ofthe equipment was that Section 218.480(b) now covers the entire Facility. Tr. at 50. Abbott would not have a problem ifthe specification were not made on the SSEC. Tr. at 50. With regard to Section 218.480(b)(4) specifically, 

### it is Abbott's understanding that the general applicability ofSection 218.480(b) still applies to the Facility. Tr. at 50. It is possible that Abbott might find the need to install a fluid bed dryer in another building for a totally unrelated manufacturing process, and thus, prefers this flexibility. Tr. at 50-51. Therefore, Abbott is comfortable with the way the rule is currently proposed. Tr. at 51. Abbott also has no objection to identifying the company in the rule. Tr. at 51. Illinois EPA provided the following testimony to address the questions ofthe Board regarding USEPA's EIP guidance that were included in the Hearing Officer Order dated March 4, 2008. The Board's USEPA EIP Guidance Question l(a) asked whetherthe USEPA guidance implies that a state should first adopt some type ofdiscretionary EIP policy before considering a request such as the one Abbotthas made. 

### In response, Mr. Yoginder 15Electronic Filing· Received, Clerk"s Office, May 1, 2008 

## * * * * * PC 2 

## * * * * * Mahajan ofIllinois EPA's Air Quality Planning Section ofthe Bureau ofAir stated that he spoke with Mr. Steve Rosenthal ofUSEPA and was told that state adoption ofan EIP policy is recommended, but not required. Tr. at 49. Mr. Mahajan also noted that Illinois EPA does not intend to adopt such a policy, but instead, prefers to deal with the issue on
a case-by-case basis. Tr. at 49. USEPA EIP Guidance Question 2 asked whether Illinois EPA believes that the proposed rule and its supporting documentation satisfies EIP principles. 

### In response, Mr. Mahajan stated that Illinois EPA discussed the issue with USEPA and confirmed that this amendment is consistent with the EIP guidelines. Tr. at 49. USEPA EIP Guidance Question 3(a) asked whether the SSEC elements are those described under Section 4.I(b) ofthe guidance on page 38. In response, Mr. Mahajan confirmed they are. Tr. at 49. USEPA EIP Guidance Question 3(b) asked whether there is any concern that the proposed combined YOM limit may not be consistent with the EIP guidelines since the baseline is calculated on the basis ofhighest actual emissions. In response, Mr. Mahajan stated that Illinois EPA had no concern. Tr. at 49. Illinois EPA discussed the issue with USEPA, and it was confirmed that the proposed combined YOM limit was consistent with the ErP guidelines. Tr. at 49. Finally, Illinois EPA indicated its support for the rulemaking. Tr. at 54. E. Economic and Budgetary Information At the Hearing, counsel for Abbott addressed the issues regarding economic and budgetary effects raised by the Board in the January 31, 2008 Hearing Officer Order. The proposed rule will, ifadopted by the Board, apply only to specific emission units 

### 16Electronic Filing· Received, Clerk's Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * 

### within Abbott's facility. The proposed rule will allow for increased operational flexibility at Abbott's facility, which, in tum, will result in more efficient and costeffective production ofpharmaceutical products. Moreover, the proposal will not impose any new requirements upon Illinois EPA, so there will be no budgetary effect. In light of the limited and site-specific nature ofthe proceeding, and the information set forth in Abbott's proposal and in Abbott's testimony presented at the Hearing, Abbottbelieves there is sufficient information in this record for the Board to make an analysis ofthe economic and budgetary effects ofAbbott's proposal. Tr. at 9-10. IV. ADDITIONAL INFORMATION PROVIDED TO THE BOARD 

### At the Hearing, counsel for Abbott noted that USEPA, through Illinois EPA, had requested that Abbott submit to USEPA supporting emissions calculations for the baseline years, 1999 and 2000. Tr. at 52. Since that time, Abbott has provided the requested information to both Illinois EPA and USEPA. 3 

### V. SITE-SPECIFIC AMENDMENT TO SECTION 218.480(b) IS PROPER 

### The testimony at the Hearing demonstrated that Abbott has worked closely with Illinois EPA and USEPA over the course ofthe last several years, and Illinois EPA has stated that it supports the rulemaking. Tr. at 54. The amendment groups the YOM emissions from the dryers for the purpose ofmeeting the emission requirements for the exemption from portions ofSubpartT and allows Abbott greater flexibility in its manufacturing process. The proposal would lower, by 24.3 ton/yr, the total amount of YOM that is allowed to be emittedbythe affected dryers pursuant to the Subpart T

3 Abbott provided annual summaries ofthe 1999 and 2000 dryer YOM emissions in an April 23, 2008 email to Mr. Matoesian and Mr. Mahajan ofIllinois EPA and Mr. Rosenthal ofUSEPA. And, in discussions with counsel for Illinois EPA, Abbott has confirmed that there is no requirement (for SIP submittal purposes) to include this additional information in the Board record in this matter. 

### 17Electronic Filing • Received, Clerk"s Office, May 1, 2008 

## * * * * * PC 2 

## * * * * * exemption. Further, the proposed amendment would allow Abbott to utilize the most efficient process unit for each batch process, irrespective ofrecent past usage ofspecific equipment. Finally, Illinois EPA supports this rulemaking. Tr. at 54. 

### VI. PROPOSED LANGUAGE Abbott proposes that Section 218.480(b) be amended as follows: b) Notwithstanding subsection (a) ofthis Section, the air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located in Libertyville Township, Lake County, Illinois shall be exempt from the rules ofthis Subpart, except for Sections 218.483 through 218.485, ifemissions ofVOM not vented to air pollution control equipment do not exceed the following levels: 1) For the air suspension coater/dryer: 2,268 kg/year (2.5 tons/year); 2) Except as set forth in Subsection 218.480Cb)C4) below, for ¥ef each fluid bed dryer: 4,535 kg/year (5.0 tons/year); 3) Except as set forth in Subsection 218.480(b)C4) below, for ¥ef each tunnel dryer: 6,803 kg/year (7.5 tons/year); aatl For fluid bed dryers #1, #2 and #3 and for tunnel dryers #1, #2, #3 and #4, the combined total annual emissions from the dryers listed in this Subsection 218.480(b)C4) shall not exceed: 18,688 kg/year (20.6 tons/year) [BOARD NOTE: tunnel dryers are otherwise referred to as warm air dryers]; and**-4~)** For each Accelacota: 6,803 kg/year (7.5 tons/year). 

### VII. CONCLUSION WHEREFORE, based upon all the evidence that has been presented to the Illinois Pollution Control Board, the requirements ofSections 27 and 28 ofthe Act (415 ILCS 5/27 and 28),35 Ill. Admin. Code 

### § 102.210 and 35 Ill. Admin. Code 

### § 102.202(b) have been satisfied in this proceeding. ABBOTT LABORATORIES, therefore, respectfully
18Electronic Filing - Received, Clerk"s Office, May 1, 2008 

### * * * * * PC 2 

### * * * * * requests that the Illinois Pollution Control Board adopt the proposed amendments to 35 Ill. Admin. Code 

### § 218.480(b). ABBOTT LABORATORIES also respectfully asks the Board to expeditiously proceed to APA second notice in this matter. Respectfully submitted, ABBOTT LABORATORIES, By: /s/ Katherine 

### D. Hodge One ofits Attorneys Dated: May 1, 2008 Katherine D. Hodge Lauren C. Lurkins HODGE DWYER ZEMAN 3150 Roland Avenue Post Office Box 5776 Springfield, Illinois 62705-5776 (217) 523-4900 ABOT:003/FilingsfPost-Hearing Comments

19