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 Quality Planning 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"
oo

A660IT PROPERJY flOUNDA~

flUID flED D~RS *TUNNEL DRYERS

lU_t~~~~:::~~,:,!?amu., .~_ao.,.,aOO7

EXHlfllTI

AERIAL PHOTOGRAPH Of Afl60IT PARK AND VICINIIY L1flERTYVILLE TOWN5HIP. ILLlNOl5

Ar~R.O)(JMATI: 5CALr:' I' _1000'_0"

300

100 500 1000 2000 2000
Electronic Filing, Received, Clerk"s Office, September 4, 2007

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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

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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 2001
Electronic Filing, Received, Clerk"s Office, September 4, 2007

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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 What programs are not covered by 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 What pollutants are covered? 16

2.3 What sources may I include in my EIP? 16

2.4 What are the objectives ofEIPs? 16

3.0 Selecting Your EIP Type 17

3.1 How do I select the type ofEIP that will work best 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 particular type ofEIP? 29

Elements ofAll EIPs

4.0 Fundamental Principles ofAll EIPs 33

4.1 How must my EIP meet the integrity principle? 34

4.2 How must my EIP meet the equity principle? 45

4.3 How must my EIP meet the environmental benefit principle? 49

5.0 Common Elements ofAll EIPS 53

5.1 What provisions 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 track results? 66

6.0 Elements ofAll Trading EIPs 73

6.1 What enforcement elements must all trading EIPs contain? 73

6.2 What provisions do I need in my trading EIP to address specific pollutant

effects? 76

6.3 What provisions do I need in my trading EIP to ensure it does not interfere

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~thotherprogrcrrns? 77

6.4 What provisions do I need in my trading EIP to address uncertainty? 79

6.5 What other provisions do I need in my trading EIP? 81

6.6 Are "emission reductions" the same as "emission reduction credits (ERCs)?" 87

7.0 Elements ofSpecific Trading EIPs 89

7.1 How do I select the appropriate trading EIP? 89

7.2 What other provisions 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 What provisions must all financial mechanism EIPs contain? 113

9.0 Elements ofClean Air Investment Funds 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 other EIPs? 121

9.4 Can I use a CAlF to address environmental justice concerns? 123

9.5 How do I establish and implement a CAlF? 123

9.6 What provisions must all CAlFs contain? 124

10.0 Elements ofPublic Information EIPs ...........•.............................. 129

10.1 What provisions must all public information progrcrrns 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 What must I submit to demonstrate my EIP is complete? 135

11.3 What must I submit for approval ifmy trading progrcrrn involves more

than my State? 137

11.4 What must I submit for approval to show my EIP is consistent ~th other

applicable laws? 137

11.5 How long ~l it take to get my EIP submittal approved by the EPA? 138

11.6 What final actions can the EPA take on my EIP SIP submittal? 138

11.7 What does it mean ifthe EPA does not :fully approve my EIP? 139

11.8 What happens if! implement my EIP before the EPA approves it? 140

12.0 Running Your Approved EIP 141

12.1 What are my responsibilities for running my EIP once it is approved? 141

12.2 HowmustIenforcemyEIP? 141

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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 of acronyms 166

16.0 Appendices 171

16.1 Special Provisions for Areas Needing and Lacking Attainment 171

16.2 VOC EIPs involving hazardous air pollutants (HAPs) 175

16.3 Emission quantification protocols 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-precursor trading 235

16.10 Provisions to ensure consistency with transportation conformity 238

16.11 Provisions for localized increases of criteria pollutant and precursor

emissions 240

16.12 Provisions for inter-credit trading 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 across jurisdictional boundaries 256

16.17 Safeguards for EIPs that allow the use of old emissions reductions 258

16.18 Provisions for opt-in sources 260

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

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List of Tables

Table 1.1: EPA Regional Air Division Directors 7

Table 3.1: Characteristics ofEIPs 18

Table 3.2: Which Sections ofthis Guidance Should I 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 Other EIPs 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 Other EIPs 44

Table 4.3(a):General Equity Principle for Trading EIPs 47

Table 4.3(b): General Equity Principle for Other EIPs 47

Table 4.4(a): Environmental Justice Element for Trading EIPs 49

Table 4.4(b): Environmental Justice Element for Other EIPs 49

Table 4.5(a): Environmental Benefit Principle for Trading EIPs 51

Table 4.5(b): Environmental Benefit Principle for Other EIPs 51

Table 7.1: Characteristics ofTrading EIPs 90

Table 10.1: Examples ofPublic Infonnation EIPs 130

Table 16.11: Significant Annual Increases for Criteria Pollutants 240

Table 16.14: NSR Requirements 247

IV
~08--g>

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3-7~D 9'

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Electronic filing. Received, Clerk·s Office, February 29, 2008

Revh~edExhibit3 (2129108)

Historical YOM Air Emissions from Tunnel Dryers and Fluid Bed Dryers at the Abbott Park Facility-

(tons per year) C

Tunnel Tunnel Tunnel

Year Drver 1 Dryer2 Drver 3

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 of production batche$. corresponding YOM content of VIe batch, and

specified loss factors for the respective equipment, as detailed in CMPP Permit section 7.1.12(e).

b Fluid Bed Dryer 3 was not operating prior to 2000.

c Some data were 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

Dry Product Dryer Bowl

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 POLLUTIONCONraOL BOARD

IN THE MATTER OF: ) '-

)

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

SITE-SPECIFIC AMENDMENT TO )

AP:?LICABl;J;.,IT¥·SEGTION,OF O.aOANIC: )

MATERIAL EMISSION STANDARDS AND)

LIMITATIONS :POR CHICAGO .A.REA;)

SUBPART T: PHARMACEUTICAL )

MANUFACTURlNG (3S ILL. ApM. CODE )

2l8.480(b» )

R08,;,8

(Rulemaking -Air)

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3-07-t??

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PRE-FILED TESTIMONY OF ROBERT C. WELLS,

IN SUPPORT OF PROPOSED SJTE..SPECIFIC AMENDMENT .

NOW COMES, ABBOTT LABORATORIES, by and through its attorneys,

~ODGE D.WYER ZEMAN, and pursuant to· 35 Ill. Admin. Code § lO2.424 and-the

Hearing Officer Order, dated January 31, 2008, submitsthe following Pre-Filed

Testimony ofRobert C. Wells for presentation at the March 7, 2008 hearing scheduled in

the above-referenced matter:

TESTIMONY OF ROBERT C. WELLS

My Dame is Rob~rt C. Wells. I am employed by Abbott Laboratories as Air

Managerfor Environmental Support in Abbott's Global Envirorunental Health and Safety

Department. ,I pro'videassistance to Abbott facilities such as Building AP16 with regard

to environmental compliance and managing environmental performance at our facilities

under various air regulations. I have twenty-nine years of experience in air quality

management and the analysis of air emissions, emission control and ambient airquaIity.

I hold aBachelor of Science degree in Engineering from Cornell University.

My testimony today conc~ns technical aspects ofAbbott's proposal'far a sitespeCific amendment'to Illinois air regulations at 35 Ill. Admin. Code P~rt 218.480(b), in
Subpart T of-Part 21.8, Abbottts proposed site-"specific amendment'concerns provisions

impacting the four (4) tunnel dryers (also referred to as warm air dryers).. and three (3)

fluid bed dryex:s located'in Building AP16 at the Abbott Park facility" The' dryers are

used to dry. mixtures of acti:ve pharmaceutical ingredients eAPls~'); exoipient ingredientst

and massing fluid after they have been processed to 'produce a solid material with im

appropriate granule size. The granulated mixture is then used to manufacture dosage

fomi products (i.e.; tablets, cap~es, and granules).

The tunnel dryers and fluid bed dryers are currently subject to air reguIatiC;lns for

Volatile Organic Material ("VOM") emissions under 35 Ill. Admin. Code Part 218,

, Subpart T. Under this'standard, an individual dryer is required to control VOM

. .

emissions iHts annual emissions exceed 7.s tons per year (tonlyr) for a·tunnel dryer or 5 .

ton/yrfor a fluid bed dryer,·

Emissions from anyone dryer vary from year to year, Historically, emissions

from each dryer have been significantly below the level that would trigger the

requirement.for add·on control. Emissions from individual dryers have b~en held below

these limits·in part by planning production to distribute YOM.em.itting production among

the different equipment.. Because Qfthe v8l'iability; and because ofthe significant cost to

install and operate con~ols for a dryer.that would not be justified, these control

thresholds effectively act as the upper limit for annual YOM emissions from an·

individual dryer.

At this time, production scheduling can be forced to assign one or more dryers to

a production campaign based on the dryers' recent past YOM emissions, assigning one or

more dryers that have low enough recent emissions to avoid exceeding a dryerthreshold,

2
but that may not otherwise be the optimal or most.efficient equipinentfor the campaign.

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; This scheduling inefficiency was identified as one area

where improvements in efficie4lcy could be made, while not mcreasing the enviroi1mental

impact ofAbbott's operations.

Two environmental management approaches were identified and considered in

order to. alleviate the inefficiency ofthe·Subpart Topetating constraints. One alternative

would be to increase the threshold that would trigger the emission control requirement for

one or moreindiviclual dryers. Such an increase would be justified ifthe cost·of control

is greater than what is considered economi<::ally achievable for Reasonably Available

Control Technology ("RACT"), which was the justification for establishing·the original

thresholdsin Subpart T. A preliminary review o.femission control costs indicated that

RAeT controls would not be justified even at emission thresholds significantly higher

than:the current limits specified in Subpart T. A second alternative would' be to treat the .

current control threshold as a combined threshold ·equal to the sum..ofthe individual unit

thresholds for the·seven manufacturing dryers. This apprpach would remove a .

manufacturing· constraint without increasing the all~wable VOM emissions from the

facility.

The above alternatives were first evaluated internally within Abbott. Under the

fIrst approac~ while Abbott believes that it would, be justifiable to increase the emission

. threshold for one ormore dryers, it would also act to increase.the facility's allowable

emissions. which is not necessary to solve problems ofmanUfacturing effioiency. The

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Ele'ctrohic~Fmng • ReceivedrClerk!-s :Officej F~br-i.iary'22,. 200.8

. . second approach,' to r&odefine the'emissipn threshold, as a combined thresho14.for all

dryers, would remedy manufacturing inefficiencies without- inc~easing overall aUQwable

VOM·emissions.

Both ofthese approaches were discussed withthe·Illinois Environmental

Protection Agency ('~IIlinois EPA''). AHhat time~ lllinois BPA indicated tha,t botI,

Illinois EPA policy and United'States EnvirtifuneJital. Protection-Agency{"USEPN')

regulations and ,guidelines would need to; be considered in orderfor' the agency40 support

a site.specific·amendment to 35m. Admin. ~ode Part,218.·

Subsequent discussions among Illinois EP USEPA, and Abbott's

representatives identified an existing USEPA program that would providesin)ilar

operational benefits as the combined threshold.approach discussed above. USEPA's

Economic lncentive Programs ("EIPs") are described in-USEPA's. document, Imp"oving

Air Quality With Economic lricentive.t}irograms, BPA~4521R·Ol·OOl, January 2001,

which was provided as Exhibit.2 to the Statement ofReasons.for the proposed site- .

speCific amendment Among other programs~ this guidance includes provisionsfor; a

Source-Specific Emission Cap (4'SSEC") as an altemativeregulatory approach for

emission limits that can·regulate emissions with greater flexibility and efikiency than

conventional approaches.

DiSCuSsions with nlinois..EPA andUSEPA indicated that a SSEC could allow

. individual.emission limitsto be combined into an aggregate cap:for~the tunnel dryers and

fluid bed dryers~ pr~vided that the SSEC is set to a·lev.el which is less thmi the upits

combined historical actual emissions, rather than equ~l to current combined allowable

emissions. Both Illinois EPA and USEPA indicatedthat a: SSEC EIP would be an

4

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Electronic Filing - Received, Clerk"s Office, February 22, 2008

acceptable method to address the applicability provisions ofSection218.480(b) with

respect to AbbQtt's tunnel dryerS and fluidized bed dryers.

Under the current regulatory standard, the combined allowable emission threshold

for Abbott's dryersis 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 fluid bed dryers at

5,0 tonlyr each. A SSEC within the EIPs would typically require allowable emissionsto

be reduced below a baseline level "defined by the historical actual emissions for the" units.

Under USEPA guidelines, hist~rical actual emissions are defined as the highest actual

emissions from any 2-year period within the last 10 years ofoperation. In addition, the

EIP requires a demonstration ofenvironmental benefit which can be achieved by setting

an emission limit 1{j percent below the baseline emissions. Such a program would be

more constraining than either ofthe two altematives proposed by Abbott. However,

while either ofAbbott's original alternatives would likely be approvable, it was

recognized that it would be more administratively efficient to 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 seven dryers are shown in Exhibit 3 ofthe

Statement ofReasons for this site-specific amendment. In accordance with USEPA

guidance, the baseline emissions for Building AP16 were calculated to be 22.9 tonlyr

based on the historical actual emissions from the highest 2-year period ofthe past 10

years. Thus, in orderto demonstrate environmental benefit as described in the E1P " "

guidance, the total allowable combined emissions from the seven dryers under the

. 5
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proposed SSEC would need to be set at a: level 10 percent lower than the calculated

baseline emissionS, or 20.6 ton/yr ofVOM.

Iilj~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 seven dryers, is 45

ton/Yr.' AlthQ~~ Abbott eqUid operate at this einissioillevel ifneeded for operations, its

historical acttial emissions have consistgritiy beeillowerthan rue cU:i.tent combined

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

tate is higher than what.A.bbott is proposing under the amehded site-specific standard.

, Abbott considers,-the'flexibilityto shift production among the..dryetsto be more important

than the ability fO operate with current maximum ov:era11 emissions. Therefore, the

" principal requirement for a SSEC under'the EIP, acomhined allowable emission

threshold lower than historical actual emissions, would be an acceptable alternative to

Abbott

In order to 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:pefitora: program that is, acc:epta1?le to all prospective parties, the

.,:

progx:am must'satisfY three fundamental principles of USEPA;s EiP program: integrity,

equity and environmental benefit. 'These are defined, E;m.d discussed:,i,n USEPA's

Improving Air Quality with Economic Incentive Program. See Exhibit 2, Statement of

, . , Reasons..-Consistency with each ofthese'three principles is discussed separately below.

The principle ofintegrity consists offour elements: emissions must be surplus,

quantifiable, enforceable, andpermanent. Note that these terms have sp¢cific meanings,

and are differe~t for a SSEC than for other programs addressed' by the policy. id. at 35.

6
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, , Electronic Filing, wi Received; Clei'k~s Officej Fti!br.uiiry,.22, 200'S

•

•

'.

.- ' Emissions are ,surplus because the baseline for the p:r;ospective'SSEq for

the seven dryers is based on the historical actual emissions for these units,

and because the program will reduce emissions below this 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 under tHe SSEc i$ based'on amass

balance fqr a S9}.Y~~t evapQ~~ion p,rQCess with VOM among the materials

used. A mass~Da1aD.ce calcUlation 'is"considered to be a very reliable

me~odoJQgy fQI: ffil!m~fyip.g YOM emi~sions on a,12-month average

basis. The ii1etiibdofogy for quantifying emissions Iro-m flit' dryers is

alrea4X well 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,part ofillinois'

State Implementation Plan for ozone attainment, and incorporated into the

facility?'S DAAPP Permit as' an applicable requirement. EnforCement will

be based on the same program that is now in place in the CAAPP Permit,

whereeniis~ions, are tracked by,mass-balance emission calculations based

on production records.

Eniissi~~s are'permanent becauSe the site-specific amendment to 35 TIL

Admin. Code. J;>art ZI8 will memoria1iz~ the cond~tions . •••11

The principle ofequity is evaluated to ensure thatthe EIPs program does not

result in "an uneven distribution ofemissions or '... effects." Id. at 46. This program is

, not ofconcern for equity issues for three reasons.

• This program focuses excJ~ively on YOM emissi<)Dsfrom one particular

facility. therefore, there is no concern for impacts in one area that must '

Qe ~al~~e~ equitably with reductions i~ another area. 1n a.dditiOIl; the EIP

,wilt r~sUIt i'n lower emissions than' the historiC actdal'emissions for the

UI1.its in the sole area ofimpact. Therefore, there will be no area of

increased environmental impact that must be''balanced against an overall

impact reduction. In concunence~ USEPA guidance indicates that equity

isSUes aretypica11y'ncit ofconcern for itsingle-site SSEC program. rd. at

SQ. '

• Emissions ofVOM have envil:onmental effects on a regional scale rather

than a localized impact. AISOt' the ove~ impa~t ofthe progt:am will be '

positive because both allowable and historical actual emissions will be

reduced.

The principle of environmental benefit is satisfied by the intention for the

prog~ to reduce emissions 10 percent below historical actual levels. While other

7
de~onstrations ofbenefits may be appropriate.the lQ percent emission reduction criteria

is clearly defmed byUSEPA as appropriate for demonstration ofenvironm.ental benefit

Id. at 51. Illinois EPA and USEPA both agreed that Abbott's proposal met the criteria for

aSSECEIP.

In sturtInaiy, th~ prcposed sitewspecific amendment will result in significant .

environmental benefits. Maximum future allowable emissions of20.6 tonlyr from the

. . .

seven dryers will be 10 percent below the historical actual emissions determined. by

USEPA criteria (22.9 tonlyr). Future actual combined emissions from the seven dryers

will be well below what is currently allowed for the units (45 tonlyr).

At the 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 without relaxing the stringency ofthe current emission control

thresholds.

I would like to thank the Board for itstime and attention in considering our.

proposal and my testimony. I would also like to thank the Illinois EPA for working with .

Abbott to identifY a practical site-specific amendment for great~r regulatory efficiency. I

would be happy to answer any questions.

)

'" *

8

*
-or

Abbott reserves,the righHosupplement!or modify this pre...iired testimony.

Respectfullysubmitted, ,

ABBOTT LABORATORIES,

By:/sf Katherine D; :Hodge,

One ofits Attorneys

Dated: February 22, 2008

Katherine 1).: Hqdge

Lauten'C.J.Ji;'Urtifis

HODGE DWYER ZEMAN

3150 Roland Avenue

Post Office Box 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 September 4, 2007, Abbott Laboratories (Abpott) filed a proposal for site-specific

rulemaking pursuant to Section 28 ofEnvironniental 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 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 on March 7, 2008, b.eginning at 1:00 p.m. Both the technical

justification and economic impact ofthe rules will be addressed at this hearing; as the Board

presently does not intend to schedule another hearing. 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, consistent with the hearing officer order, Abbott prefiled testimony

ofDiane Beno and Robert C. Wells.. The Illinois Environmental Protection Agency (Agency)

has not prefiled any testimony. No other testimony has been prefiled.

In the. interest offacilitating the hearing process, the Board has reduced to writing

questions it would like the participants to address at hearing, and is making them availabl~ to

partidpants in advance ofhearing. These questions appear on pages 2-5 ofthis order. While

some questions are addressed to partiCUlar witnesses, any participant is free to address any ofthe

questions.

The hearing officer has 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. On page 3, the Statement ofReasons (SOR) states that the current YOM requirements at

Section 218.480(b) are based on the provisions ofSection 215.480(b), which was adopted

by the Board on April 7, 1988 in Docket R86-1O. Further, the SOR states that during

the rulemaking in R86-10 both the petitioner and IEPA "provided technical

documentation and testimony to the effect that certain emission sources, including tunnel

dryers and fluid bed dryers, would be economically infeasible to control at the levels

required for certain other emission sources at the facility."

. a) Please comment on whether the infonnation/testimony presented in the 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 since the

adoption ofthe original rules that addresses the economic concerns associated

with control of emissions 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 per year 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 whether Abbott has stopped operating

dryer #4.

Premed Testimony - Diane Beno

1. On page 2, you state that the organic solvent currently used for massing fluid in AP-16 is

ethanol. Please comment on whether Abbott has 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 ofsolvent used for massing fluid, i.e.

whether the 'solvent type is mainly dependent on the product being manufactured or the

type ofsolvent is also dependent on the 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 ofwater for the massing fluid.

a. Please comment on whether Abbott anticipates increased use ofwater in product

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 explain what role, if any, pollution prevention (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 product than tunnel dryers.

a. Please explain how the fluid bed dryers are more efficient than the tunnel dryers.

b. Does Abbott have any plans to replace the tunnel dryers with fluid dryers?

5. Qn page 4, you state that under the current rules, Abbott may be required to utilize a

dryer with low YOM emissions during the last 12 months instead ofusing the dryer that

is most efficient from a production-scale standpoint to ensure compliance with the current

running i2-month total YOM limit on each dryer.

a. Please clarify what you mean by "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-year period within 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, please provide 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 period prior to the source's participation in

ElP, usually representing the average emissions ofthe past tWo years or some other more

representative period:'

.. a. Please explain why the baseline was not calculated on the basis of average

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.

USEPA's Economic Incentive Program Guidance

1. At page 3, the EIP guidance states that the guidance applies if a state or tribe wants to

establish a discretionary EIP for attaining or maintaining the national ambient air quality

s.tandards (NAAQS) for criteria pollutants. Further, the guidance notes that any

government agency with the authority to administer a SIP or TIP may adopt a

discretionary EIP.

a. Does the above statement imply that the state should first adopt some type of a

discretionary ElP policy before 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 request made under the

USEPA's EIP in lllinois.

2. At page 6, Mr. Wells states that in order to ensure that the proposed site-specific

amendment is consistent with USEPA ElP guidance, and to realize the administrative

benefit of a program, the program must satisfy three 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.

Further he notes that these terms have specific meanings, and are different for a source

specific emissions cap (SSEC) than for other programs 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 limit may not be 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 existing rules 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 must be submitted. See 35 Ill. Adm. Code 102.1os. As the Board

is aware that Abbott would appreciate Board decisionmaking as soon as possible, the

posthearing comment period will not be lengthy unless lmanticipated circumstances dictate

otherwise.

IT IS SO ORDERED.

2

Kathleen

~h~~ M. Crowley

Hearing Officer, lllinois Pollution Control Board

100 West Randolph Street, Suite 11-500

Chicago, lllinois 60601

(312) 814-6929 crowlek@ipcb.state.i1.ns
3

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 ofAbbott Park 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 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"
4

CERTIFICATE OF SERVICE

It is hereby certified that true copies ofthe foregoing order were 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 order was 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.us
R2008-008

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 62702-1271
IEPA 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

of which 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 6060 I

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 of Legal 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 of Legal 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 of the

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-01-001" to "EPA-452/RO1-001"

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 of its 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

2
rEPA ATIACHMENT NO I3

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) 782-5544
Electronic 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 of volatile organic material ("VOM") from its combined fluid bed dryers and tunnel

dyers in lieu ofrate-based limits provided in Section 218.480(b). The net effect ofthe proposal

will result in a reduction of24.5 tons per year ofVOM emissions.

The Illinois EPA has determined that the proposal will not adversely affect the air quality

in Illinois. The Illinois EPA further consulted the United States Environmental Protection

Agency ("USEPA") and concluded that the proposal is consistent with the guidelines of

USEPA's Economic Incentive Program. Accordingly, after reviewing Abbott's petition, the

Illinois EPA supports the requested site-specific relief.
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)

2
Electronic 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) 782-5544
Electronic 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 62701
Electronic 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 of which 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 DWYER ZEMAN

3150 Roland Avenue

Post Office Box 5776

Springfield, Illinois 62705-5776

(217) 523-4900

THIS FILING SUBMITTED ON RECYCLED PAPER
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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 of Legal 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 Comments
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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).
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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 of Diane Beno in

Support ofProposed Site-Specific Amendment and the Prefiled Testimony ofRobert C.

Wells in Support of Proposed 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 31 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 of 20.6 tons per year; 4) add Note c to identify

the round-off issue 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 sought to 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 of values 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 nearest 0.1 ton per

year in revised Exhibit 3.

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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, Abbott produces

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) of Subpart 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 of exempted emissions from these dryers based on their actual

combined emissions. If adopted, 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 direct testimony and in

response to questions ofthe Board. Abbott presented two witnesses: Diane Beno, the

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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 of Air.

A. Facility Process and Affected Emission Units

In Building AP16 at the Facility, Abbott produces intermediate and final

pharmaceutical product fonuulations. Pre-Filed Testimony of Diane 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. If an 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

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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 diffuser that

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 of different scales, with some

for large batches and others for small batches. Beno at 4. Therefore, the scale of a 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.

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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 of product 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 different products processed in a dryer over a rolling 12-month period.

Beno at 5. The assignment of a campaign of a particular product to one or more dryers

involves a number of operating factors, such as scale and equipment availability, that

contribute to the efficiency of manufacturing. Beno at 5. The YOM emission threshold

effectively acts as an overriding factor that can force a particular production 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 Facility remains competitive with its national and

global competitors, Abbott must continually seek ways of making its manufacturing

operations more efficient. Beno at 5. The scheduling inefficiency created by Subpart T

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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 of YOM 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 of operation would not require an increase in allowable YOM

emissions from the Facility. Beno at 6. In fact, 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 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 of 45 ton/yr. Tr. at 25. Because ofthe cost associated with YOM control for this

type of equipment, 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 of production 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

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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 of Air 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-year period. 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 half ofthe

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.

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In going forward with the SSEC EIP approach, Abbott considered its

confonnance with the three general principles of an 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 of the 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 of March 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 the Best

Available Control Technology ("BACT") analysis. Tr. at 32. Using the BACT analysis,

Abbott found that the cost of control 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.

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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 Abbott produces in a given year can vary based 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 of Reasons 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

should production needs demand. Tr. at 35.

Beno Prefiled Testimony Question 1 asked whether Abbott has used organic

solvents other than ethanol in the manufacture of pharmaceuticals in the past. In

response, Ms. Beno stated that ethanol has been the only organic massing fluid used by

Abbott in Building AB16 during the ten-year period under review for the proposal. Tr. at

37. In late 2002, however, the type of ethanol used was denatured ethanol, which

contains a small percentage ofmethanol as the denaturant. Tr. at 38. Since late 2002,

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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 of a

product, not whether or not water is an option. Tr. at 38. The type of dryer 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

of water 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 of massing

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 considered by Abbott

as the benefits resulting from increased use ofwater for the massing fluid. Tr. at 39-40.

Other benefits include increased raw material costs, reduced worker exposure to organic

materials in the work place, and improved safety due to reduction offlammable solvents.

Tr. at 40.

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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 a number 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 of the granule in the drying process. Tr. at 40. This results in a much more 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 other parts. 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 a much more uniform drying process.2

Beno Prefiled Testimony Question 4(b) asked whether Abbott has any plans to

replace the tunnel dryers with fluid bed dryers. In response, Ms. Beno stated that Abbott

does not expect to phase out tunnel drying equipment or concentrate on purchasing new

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

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fluid drying equipment because switching technologies can have an impact on the safety

and efficacy of a 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 current rule 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 of dryer 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 either by 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 if one 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

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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 of historical

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 particular period was representative, so USEPA changed the

definition of actual 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 ifit 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

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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 that by more

than half. Tr. at 47-48.

Proposed Amendment Question 1 asked whether the rules at Section 218.480(b)

should state that the 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 of Section 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 whether the USEPA

guidance implies that a state should first adopt some type of discretionary EIP policy

before considering a request such as the one Abbott has made. In response, Mr. Yoginder

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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 of an 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 of highest 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, if adopted by the Board, apply only to specific emission units

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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 of pharmaceutical 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, Abbott believes

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 ofSubpart T 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 emitted by the 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.

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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, if emissions ofVOM not vented to air pollution

control equipment do not exceed the following levels:

1) For the air suspension coater/dryer: 2,268 kg/year (2.5

tons/year);

2) Except as set forth in Subsection 218.480Cb)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 of Sections 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

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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

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