BEFORE THE ILLINOIS
POLLUTION CONTROL BOARD
O F:
ABBOTT LABORATORIES'
PROPOSED
-SPECIFIC AMENDMEN
PLICABILITY
SECTION OF ORGANIC
TERIAL EMISSION
STANDARDS AND )
LIMITATIONS FOR THE CHICAGO AREA; )
SUBPART T:
218.480(b))
Kathleen
M. Crowley
Hearing
Officer
Illinois Pollution Control Board
100 West Randolph Street
NOTICE OF FILING
TO: Mr. John Therriault
Assistant Clerk of the Board
ois Pollution Control Board
100
West
Randolph Street
-500
g o, Illinois 60601
ELECTRONIC MAIL)
e 11-500
R08-8
(Rulemaking - Air)
Illinois
60601
(VIA U.S. MAIL)
ACHED SERVICE L
ICE that
linois Pollution Control Board MOTION
is herewith served upon you.
Respectfully submitted,
By:
Dated: April 7, 2008
ine D. Hodge
Lauren C. Lurkins
HODGE DWYER 2E
3150 Roland Avenue
Post Office Box 5776
62705-5776
THIS TILING SUBMITTED ON RECYCLED PAPER
Electronic Filing - Received, Clerk's Office, April 7, 2008
CERTIFIC OF SERVICE
I, Katherine
D. Hodge, the undersigned, hereby certify
that I have served
MOTION TO CORRECT TRANSCRIPT
upon:
Assistant
Clerk of the Board
Illinois Pollution Control Board
100 West Randolph Street
Suite
I1-500
ago, Illinois 60601
via electronic mail on April 7, 2005; and upon:
Kathleen M. Crowley
Matthew J. Dunn, Chief
Hearing Officer
Environmental
Bureau North
ois Pollution Control Board
Office of the Attorney
General
'hompson Center
69 West Washington Street, Suite 1800
100 West Randolph Street, Suite 11-500
Chicago, Illinois
60602
Chicago, Illinois 60601
ion Agency
ue East
Post Office Box 19276
62794-9276
Resources
linois 62702-1271
ument in the United States Mail, postage pre
on April 7, 2008.
/s/ Katherine D.
A BOT:003/FilingsiNOF & COS, Mtn to Correct Transc
Electronic Filing - Received, Clerk's Office, April 7, 2008
BEFORE THE ILLINOIS POLLU'.
OF:
BOTT LABORATORIES' PROPOSED
SITE-SPECIFIC AMEND
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
aking -Air)
MOTION TO CORRECT
ES AB
RAN SCRIPT
OTT LABORATORIES, by and through its attorneys,
HODGE DWYER ZEMAN, and pursuant to 35 Ill. Admin. Code
ยง
1
3
3
Pollution Control Board ("Board") order the correction
his matter held on March 7, 2008. as .follows:
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11
ION CONTROL BOARD
01..604, requests that
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
Change
"apply" to "applies"
Change "effected" to "affected"
Change "Program" to "Programs"
Change
"EIP's" to "ElPs"
Change "EPA-452/R-01-001" to "EPA-452/R_01-001"
Change "Granulation Process Fluid Bed Drawi
"Granulation Process - Fluid Bed Drying"
Change "air" to "bed"
rt "and" after "months"
Change "results" to "result"
Change`
Change "effected" to "affected"
Change "One be
to
"One would be to"
Electronic Filing - Received, Clerk's Office, April 7, 2008
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Change "insure" to "ensure"
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Change "record keeping"
to "recordkeeping"
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Change "Exhibit 8" to "Exhibit
6"
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Change "rule making" to "rulemaking"
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Change "rule making" to "rulemaking"
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Change "over"
to "after"
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Change "tunnel dryer three"
to "tunnel dryer four"
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Insert "of' after "some"
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Change "tectmology.
Meaning" to "tect-mology, meaning
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Change "batch, and then"
to "batch. And then"
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Change "ethanol, use not" to "ethanol use, not"
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Delete the
comma after
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Delete the comma
after
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Change "that is ," to
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Change "PSR" to "PSD"
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Change "80.186" to "80186"
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Change the period to a question mark
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Change "28.480(b)" to "218.480(b)"
WHEREFORE, for
ons set forth above,
0
hearing transcript as set
forth above.
Respectfully
submitted,
DRIES,
By: /s/ Katherine D. Hoc
One of its Attorneys
Dated: April 7, 2008
erine D. Hodge
Lauren C. Lurkins
HODGE
DWYER ZEMAN
3150 Roland Avenue
Post Office Box 5776
I
217)
523-4900
s 62705-5776
ABOT:003/Filings/Motion to Correct Transcript
Electronic Filing - Received, Clerk's Office, April 7, 2008
1
1
BEFORE THE ILLINOIS POLLUTION CONTROL BOARD
2
3 IN THE MATTER OF:
)
4
)
5 ABBOTT LABORATORIES'
)
6 PROPOSED SITE-SPECIFIC
)
7 AMENDMENT TO APPLICABILITY
)
8 SECTION OF ORGANIC MATERIAL ) NO. R08-8
9 EMISSION STANDARDS AND
) (Rulemaking-Air)
10 LIMITATIONS FOR THE CHICAGO )
11 AREA; SUBPART T:PHARMACEUTICAL )
12 MANUFACTURING (35 ILL.ADM.CODE )
13 218.480(b)
)
14
15
16
REPORT OF PROCEEDINGS had before the
17 ILLINOIS POLLUTION CONTROL BOARD held on March 8,
18 2008, at 1:00 o'clock p.m. at the Libertyville
19 Village Hall, 118 Cook Road, Libertyville, Illinois.
20
21
22
23
24
2
1 A P P E A R A N C E S:
2
MEMBERS PRESENT:
3
4 ANAD RAO, CHAIRMAN
THOMAS E. JOHNSON, MEMBER
5 NICHOLAS J. MELAS, MEMBER
6
7 CHARLES MATOESIAN
8 Illinois Environmental Protection Agency
9
HODGE DWYER ZEMAN
10 BY: MS. KATHERINE D. HODGE
3150 Roland Avenue
11 Post Office Box 5776
Springfield, Illinois 62705-5776
12 (217) 523-4900
13
On behalf of Abbott Laboratories;
14
15
16
17
18
19
20
21
22
23
24
3
1
MS. CROWLEY: Good afternoon. This is
2
a hearing being conducted by the Illinois
3
Pollution Control Board in a matter of
4
our docket number R08-8 Abbott Laboratories
5
proposed site specific amendment to
6
applicability section of organic material
7
emission standards and limitations for the
8
Chicago, Subpart-T, Pharmaceutical
9
manufacturing at 35 Illinois Administrative
10
Code 218.408(b).
11
The Board opened this docket
12
October 4th to consider Abbott's proposal for
13
site specific rulemaking. In addition to
14
myself, present from the Board today are
15
seated to my immediate right, Board member
16
Nicholas J. Melas, who is the lead Board
17
member for this rulemaking. Seated to my
18
immediate left is Anad Rao, an environmental
19
engineer on the board's technical staff, and
20
seated to Mr. Rae's left is Board member
21
Thomas E. Johnson.
22
Board member Andrea Moore asked me
23
to remind you that she is abstaining from any
24
participation in the hearing or decision
4
1
making in this rulemaking as she owns a small
2
amount of stock in Abbott and also has close
3
family members who are employed by Abbott.
4
Would you like to make any remarks at this
5
point, Mr. Melas?
6
MEMBER MELAS: Nothing else but to
7
welcome you all here. It will be a pleasure
8
listening to the answers to the pre-filed
9
questions.
10
MS. CROWLEY: Today we're holding the
11
first and only hearing currently scheduled in
12
this rule making. I see that there are no
13
members of the public present so I will cut
14
short the introductory remarks that we
15
usually make a little bit.
16
The proceeding is governed by the
17
Board's procedural rules. All information
18
that is relevant and not repetitious is
19
admitted into the record. The Board makes
20
its rulings on the basis of its sworn and
21
transcribed records. So the hearing officer
22
will be asked to swear in the witnesses. I
23
also want to remind you that any questions
24
that may be posed today by any member of the
5
1
Board or staff are intended solely to develop
2
a complete and clear record for the Board and
3
are not intended to reflect any prejudgment
4
of the proposal.
5
The hearing today will consider
6
both the technical justification of the
7
proposal, as well as any economic impact of
8
the proposed rules as required by Section
9
27-B of the Environmental Protection Act. On
10
October 18, 2007 the Board requested The
11
Department of Commerce and Economic
12
Opportunity to conduct an economic impact
13
study. That department has not responded to
14
this request or pre-filed a study within the
15
45-day period the Act provides, so the Board
16
will be basing its decision on the economic
17
information that is provided today and in any
18
post-hearing comments. The Board has
19
received pre-filed testimony in this
20
proceeding only from the two witnesses from
21
Abbott. We also have some pre-filed
22
questions that were developed by the Board
23
and given to the parties on March 4, 2008.
24
So we will begin, I think, by asking the
6
1
attorneys to introduce themselves and then we
2
will turn the proceedings over to Ms. Hodge
3
for Abbott.
4
MS. HODGE: Thank you very much. Good
5
afternoon, everyone. Thank you for allowing
6
us to come here today to present support for
7
our proposal. My name is Katherine Hodge,
8
H-O-D-G-E, and I'm with the Hodge Dwyer
9
Zeeman here today representing Abbott
10
Laboratories.
11
MR. MATOESIAN: Good afternoon. I'm
12
Charlie Matoesian. I'm with the Illinois
13
Environmental Protection agency. I'm hearing
14
appearing for the agency, although we are not
15
part of the filing per se.
16
MS. HODGE: Also present with me today
17
on behalf of Abbott Labs is Mr. Steve
18
Ziesmann, right here. He is the senior
19
counsel for legal and regulatory compliance
20
for Abbott. Diane Beno, to my immediate
21
left. She is the manager of Abbott's
22
operations in building AB16, some of which
23
are the topic for this proceeding. Mr. Bob
24
Wells to her left, and Bob is the air manager
7
1
for environmental support in Abbott's global
2
environmental health and safety department
3
and then Mr. Keith Marhafka, and he is the
4
environmental health and safety manager for
5
building AB16.
6
MS. CROWLEY: I'm sorry, I didn't
7
catch the first and last names, if we could
8
say them again.
9
MS. HODGE: Steven Ziesmann,
10
Z-I-E-S-M-A-N-N. Diane Beno. Robert Wells.
11
You have that, and Mr. Keith Marhafka, M-A-R-
12
H-A-F-K-A.
13
MS. CROWLEY: Thank you.
14
MS. HODGE: And I have just a short
15
opening statement to make, and then we'll
16
move on to our two witnesses for today.
17
Abbott owns a pharmaceutical
18
manufacturing building located at 100 Abbott
19
Park Road in Unincorporated Lake County in
20
Libertyville Township, Illinois. Abbott
21
produces a number of pharmaceutical products
22
at this facility. And these operations are
23
subject to 35 Illinois Administrative Code,
24
Subpart-T, Pharmaceutical Manufacturing. As
8
1
it is currently written, Subpart-T, and in
2
particular section 218.480(b) contains
3
certain exemptions that are applicable to
4
Abbott's air suspension of coater dryers,
5
fluid bed dryers, tunnel dryers, and
6
accelacotas, a-c-c-e-l-a-c-o-t-a-s, located
7
in building AB16 of the facility.
8
Today through our testimony and in
9
response to questions, we intend to
10
demonstrate that Abbott's proposal to amend
11
these site specific exceptions will, one,
12
allow Abbott to use the combined actual
13
emissions from its effective tunnel bed
14
dryers and fluid bed dryers to determine the
15
applicability of Subpart-T to these units;
16
and, two, decrease the overall VOM emissions
17
that would be allowed below the level of
18
historical actual emissions from the tunnel
19
dryers and fluid bed dryers as a group
20
relating to the 35 Illinois Administrative
21
Code, Section 218.480(b), the VOM exemption,
22
while at the same time increasing operational
23
flexibility by allowing preferential use of
24
the more efficient dryer or dryers for a
9
1
particular manufacturing campaign.
2
The proposed amendment also will
3
not impose any new control requirements on
4
any other source other than Abbott's
5
facility. The proposed amendment will not
6
result in any increase in emissions. First
7
before offering testimony in support of our
8
proposal, I would like to address a matter
9
raised in the hearing officer order dated
10
January 31, 2008. As you know, Ms. Crowley
11
requested Abbott to address economic and
12
budgetary effects, issues associated with our
13
proposal. In that regard, the proposed rule
14
if adopted by the Board apply only to
15
specific emission units within Abbott's
16
facility, and again the proposed rule will
17
allow for increased operational flexibility
18
at Abbott's facility which in turn will
19
result in more efficient and cost effective
20
production of pharmaceutical products.
21
Moreover the proposal will not impose any new
22
requirements upon the Illinois EPA, so there
23
will be no budgetary effect. In light of the
24
limited and site specific nature of the
10
1
proceeding and the information set forth in
2
Abbott's proposal and the testimony to be
3
presented today in answers to questions,
4
Abbott believes there's sufficient
5
information in this record for the Board to
6
make an analysis of the economic and
7
budgetary effects of the proposal. However,
8
Abbott would be happy to answer any questions
9
the Board may have on this topic.
10
Abbott will present two witnesses
11
today, and first Ms. Diane Beno. She is the
12
plant manager of the portion of the Abbott
13
facility internally known as Building AB16.
14
Ms. Beno will provide information about the
15
processes carried out in Building AB16 and
16
the products manufactured at that location.
17
Mr. Robert Wells is the air manager for
18
environmental support in Abbott's Global and
19
Environmental Health and Safety Department,
20
and he will testify as to the technical
21
description of the process and dryers at
22
issue in this rulemaking. He will also
23
discuss the current rule and explain how it
24
causes inefficiencies in the operations, and
11
1
then he will discuss the methods Abbott has
2
utilized in an attempt to alleviate those
3
inefficiencies. Finally, Mr. Wells will
4
discuss the emissions from the effected
5
dryers from both a historical and prospective
6
perspective. The testimony of these two
7
witnesses also will demonstrate that Abbott
8
has worked closely with the Illinois EPA and
9
the US EPA on this issue over the course of
10
several years. We thank both the Illinois
11
EPA and the US EPA for working with us in
12
trying to resolve this issue and we
13
appreciate Illinois EPA's participation here
14
today.
15
As set forth in Abbott's proposal
16
that was filed with the Board on September 4,
17
2007, Abbott's testimony today will focus on
18
the concept called the "Source Specific
19
Emissions Cap EIP." Abbott included a full
20
copy of the US EPA guidance document entitled
21
"Improving Air Quality With Economic
22
Incentives Program," and that was included as
23
Exhibit 2 to our initial proposal. The EIP
24
guidance provides direction on a number of
12
1
types of EIPs, including the source specific
2
emission caps. The EIP guidance provides
3
that there are fundamental principles that
4
must be included in every EIP; number one,
5
integrity; number two, equity; and three,
6
environmental benefit. All EIP's must
7
contain four elements that compose the
8
integrity principle: Surplus, quantifiable,
9
enforceable and permanent. Second, with
10
regard to the equity principle, all EIP's
11
must contain an element of general equity.
12
Finally as noted, all EIP's must demonstrate
13
environmental benefit.
14
A source specific emissions cap
15
EIP allows a specified stationary source or a
16
limited group of sources that are subject to
17
a rate based emission limit to meet that
18
requirement by accepting a mass based
19
emission limit or cap rather than complying
20
directly with the rate based limit. The US
21
EPA's stated goal for this type of EIP is
22
compliance flexibility. Abbott in
23
consultation with both the Illinois EPA and
24
the US EPA relied upon and followed this
13
1
federal guidance in formulating its proposal.
2
Mr. Wells will provide additional detail in
3
how Abbott's proposal is consistent with the
4
Federal guidance for source specific
5
emissions cap EIP's.
6
With that, if there are no
7
questions, I would like to move ahead with
8
the testimony of Ms. Diane Beno and Mr. Bob
9
Wells. And Ms. Beno is going to, her
10
testimony is short and she would like to go
11
ahead and read that into the record. Bob's
12
testimony, we're happy to enter into the
13
record as if read, but he would like to offer
14
a summary, and we'll be happy to move to
15
Board questions or, you know, to agency
16
questions as appropriate.
17
MS. CROWLEY: Can we go off the record
18
for a one moment.
19
(Discussion off the record, after
20
which the following proceedings
21
were had:)
22
MS. CROWLEY: Go back on the record.
23
We discussed briefly entering some of the
24
exhibits to the original proposal as hearing
14
1
exhibits just to keep the record tidy. So
2
the first Exhibit will be Exhibit 1, which is
3
an aerial photograph of Abbott Park and
4
vicinity in Libertyville Township and is so
5
labeled. The second will be the US EPA
6
document that is entitled "Improving Air
7
Quality With Economic Incentive Programs"
8
prepared by the United States Environmental
9
Protection Agency, dated January 2001, and
10
that is EPA document number EPA-452/R-01-001.
11
And then finally, the third exhibit is
12
Exhibit 3 entitled "Revised Exhibit 3," dated
13
2-29-08 entitled "Historical VOM Air
14
Emissions From Tunnel Dryers And Fluid Bed
15
Dryers At The Abbott Park Facility." For the
16
record this is slightly revised from the copy
17
that was attached as Exhibit 3 to Abbott's
18
original September 4th proposal. So those
19
are marked and entered into the record as
20
exhibits.
21
Now you may proceed.
22
MS. HODGE: Thank you. I do have
23
extra copies of this pre-filed testimony here
24
today, but I'm assuming everyone has a copy.
15
1
With that, I think we're ready to move ahead
2
with Ms. Beno. And I'm not sure how you want
3
to handle the --
4
MS. CROWLEY: I'm sorry, I didn't
5
quite hear that.
6
MS. HODGE: I think we're ready to
7
move forward.
8
MS. CROWLEY: Yes, go ahead.
9
(WITNESSES SWORN.)
10
DIANE BENO
11 Having been first duly sworn, was examined and
12 testified as follows:
13 BY MS. BENO:
14
Thank you for the opportunity to
15 speak here today. My name is Diane Beno. I am the
16 plant manager of the portion of the Abbott
17 Laboratories facility internally known as AB16. The
18 operations contained in AB16 produce intermediate
19 and final product formulations including liquids,
20 tablets, capsules packaged in bottles and blister
21 formats. The general process flow includes receipt
22 of raw materials, weighing of ingredients, massing
23 and granulation of ingredients, coating tablets or
24 particles, printing symbols onto tablets and
16
1 packaging finished products for distribution.
2
Over the course of a year we
3 produce many different products in building AB16.
4 For example, we produce products that treat diseases
5 in the field of neuroscience such as epilepsy and
6 bipolar disorder. We make anti-viral products for
7 the treatment of AIDS. We manufacture products to
8 fight infection. We package products that help
9 patients achieve healthy cholesterol levels and
10 products that improve the lives of people with
11 rheumatory arthritis, psoriasis and Crohn's disease.
12 We manufacture our products using batch production
13 processes. In batch production all of the
14 processing equipment in a process train, including
15 the dryers, manufactures one product at a time.
16 Each batch is completed before the manufacture of
17 the next batch begins. In a typical process, the
18 active and inactive ingredients are combined with
19 the liquid in a process called massing. The massing
20 process forms uniform granules. The wet granules
21 are dried in tunnel dryers or in fluid bed dryers
22 and then further processed into tablets or capsules.
23 The massing fluid which is typically either water or
24 ethanol is evaporated from the solid material in the
17
1 drying step. If an organic solvent is volatilized
2 from the dryer, it is emitted to the ambient air as
3 VOM or VOC. The quantity of VOM emissions will vary
4 for different products and is calculated from the
5 quantity of VOM added to the mixture and loss
6 factors defined for the dryers and specified in the
7 Clean Air Act Permitting Program permit for the
8 facility. It's also important to note that the
9 organic solvent currently used in granulation and
10 dried from the granulated mixtures in building AB16
11 is ethanol. Ethanol is a VOM, but it's not
12 considered a Hazardous Air Pollutant or HAP. The
13 proposed site specific amendment will have no impact
14 on HAP emissions.
15
Abbott's proposed site specific
16 amendment for building AB16 covers four tunnel
17 dryers and three fluid bed dryers. One additional
18 fluid bed dryer located in building AB16 is used
19 exclusively for research and development and is not
20 involved in the normal operating processes in
21 building AB16; therefore our proposed amendment does
22 not include that dryer. The tunnel dryers and fluid
23 bed dryers operate on different principles. We have
24 some diagrams here to help explain this point, so
18
1 I'll go ahead and pass these out. I think this will
2 help us make a point. I think this will be helpful
3 as we get into the pre-filed questions later on. So
4 as I stated --
5
MS. CROWLEY: Just one moment. I'd
6
like to mark this as Exhibit 4, if you have
7
no objection, and it's a single-page document
8
with a heading "Granulation Process Fluid Bed
9
Drawing." Thank you. Go ahead.
10
MS. BENO: The tunnel dryers and fluid
11
bed dryers operator on different principles.
12
In the use of tunnel dryers depicted on the
13
lower half of the exhibit, materials are
14
spread on trays and placed in a warming
15
chamber or tunnel that circulates warm air
16
over and under the trays. As shown in the
17
upper portion of the diagram, a fluid bed
18
dryer is a large vertical cylindrical shaped
19
vessel with a diffuser that blows warm air up
20
from the bottom of the vessel. The wet
21
intermediate granules are loaded into the
22
dryer, and flow upward suspended in a warm
23
air stream.
24
Abbott has increased its use of
19
1
fluid air dryers for recently developed
2
products because they are more efficient and
3
produce a more uniform product than the
4
tunnel dryers. Abbott anticipates increased
5
use of water for massing fluid in future
6
products, and Abbott expects that this
7
preferential use of fluid bed dryers and
8
water based products will continue. That is,
9
many new products are expected to use fluid
10
bed dryers and water based formulations,
11
while older products continue to be
12
manufactured using tunnel dryers.
13
Batches of specific products are
14
typically manufactured using either one or
15
more tunnel dryers or one or more fluid bed
16
dryers, but not both because the technologies
17
are not interchangeable. Individual dryers
18
of the same type can typically be used in
19
combination or interchangeably in many cases,
20
but specific dryers are preferable for
21
combining with other equipment in a process
22
train to manufacture certain products from an
23
operational efficiency standpoint.
24
Abbott manufactures its batch
20
1
processes whereby each manufacturing process
2
train and its associated equipment, including
3
the dryers, produces one product at a time in
4
fixed batch sizes. Process trains are
5
designed to accommodate batches of different
6
scales with some for large batches and some
7
for small batches. Therefore, the scale of a
8
given batch plays an important role in
9
determining which of the dryers will be most
10
efficient. Additionally, in accordance with
11
the U.S. Food and Drug Administration current
12
good manufacturing processes, extensive
13
equipment cleaning is required between
14
batches of different products, resulting in
15
up to three days of lost production time.
16
Therefore Abbott uses a campaign strategy to
17
continue running batches of the same product
18
consecutively in the process train to
19
minimize this cleaning time.
20
As currently written 218.480(b)
21
effectively defines a 12 month total VOM
22
limit on each individual dryer. This can
23
limit Abbott's ability to schedule the
24
campaigns of certain products to maximize the
21
1
efficiency of the processes. In other words,
2
to insure compliance with the current 12
3
month VOM limit on each dryer for a
4
particular batch, Abbott may be required to
5
utilize a dryer with a low VOM emissions
6
during the last 12 months, instead of using
7
the dryer that is most efficient from a
8
production scale standpoint. Such selection
9
of dryers is based only on the amount of VOM
10
that has been emitted from an individual
11
dryer during the preceding 12 months is an
12
inefficient approach to the scheduling of
13
Abbott's equipment and resources.
14
Additionally, the dryer selected for a given
15
campaign also depends on dryer availability
16
and other factors. For example, one dryer
17
may be temporarily out of use to allow for
18
cleaning or for unscheduled maintenance
19
requirements; therefore the standards as
20
currently defined can result in wasted
21
resources by requiring Abbott to dry a small
22
batch of our product in our large scale
23
process train to maintain our equipment
24
specific VOM limits. Total annual emissions
22
1
from a dryer result in a quantity of organic
2
solvent removed from the different products
3
processed in a dryer over a 12-month rolling
4
period. The material is processed in a
5
number of individual campaigns for particular
6
products each consisting of multiple
7
individual batches. The assignment of a
8
campaign of a particular product to one or
9
more dryers involves a number of operating
10
factors, such as the scale and equipment
11
availability that contribute to the
12
efficiency of manufacturing. The VOM
13
emission threshold effectively acts as an
14
overriding factor that can force a particular
15
production campaign with VOM emissions to be
16
scheduled using equipment that has low enough
17
recent emissions to avoid exceeding a dryer's
18
threshold, but that may not otherwise be the
19
optimal or most efficient equipment for the
20
campaign. This scheduling shift increases
21
the operational cost, but results in no
22
environmental benefit because the actual
23
emissions will be the same as if the campaign
24
would have used the optimal equipment.
23
1
In order to assure Abbott's Lake
2
County manufacturing facilities remain
3
competitive with our national and global
4
competitors Abbott must continually seek ways
5
of making our manufacturing operations more
6
efficient. The scheduling inefficiency
7
created by Subpart-T was identified as one
8
area where improvements in efficiency could
9
be made and is the basis for the proposed
10
amendment. This seems particularly
11
appropriate as the business costs created by
12
this efficiency results in no environmental
13
benefit. The most efficient method to
14
manufacture Abbott's products in AB16 would
15
be to use the dryer that is best suited to
16
the requirements of the production schedule
17
and scale, regardless of the amount of VOM
18
that has been emitted from that dryer in the
19
past 12 months. Provided that the combined
20
VOM emissions from all of the dryers are less
21
than the combined amount allowed under
22
section 218.480(b), this method of operation
23
would not require an increase in allowable
24
VOM emissions from the facility. In fact,
24
1
the proposed amendment would provide Abbott
2
improved production flexibility to utilize
3
the most efficient dryers for a given product
4
while significantly lowering the total
5
allowed VOM emissions for all of the dryers
6
combined.
7
Thank you. I'll be happy to
8
answer any questions.
9
MS. HODGE: Shall we move on to Bob.
10
Why don't you go through a summary of your
11
testimony, and then we'll be happy to turn to
12
the Board's questions well.
13
MS. CROWLEY: That's certainly
14
acceptable.
15
MR. WELLS: I am going to attempt to
16
summarize my testimony in a shorter summary
17
than the actual testimony. My name is a
18
Robert Wells. I'm air manager for
19
Environmental Support in Abbott's Global EHS
20
Department. I've been assisting the EHS
21
staff with regulatory statutes with our
22
proposal, and I'm going to touch on some of
23
the technical points that relate to why we
24
proposed what we did and where we see that
25
1
we're consistent with the approaches that
2
we've proposed.
3
The concern today is for
4
provisions applicable to seven of the Abbott
5
parking units, four tunnel dryers and three
6
fluid bed dryers. Subpart-T requires VOM
7
controls for tunnel dryers and fluid bed
8
dryers if their annual emissions exceed
9
seven-and-a-half tons per year for an
10
individual tunnel dryer and five tons per
11
year for individual fluid bed dryers. The
12
seven units therefore have a total potential
13
emissions without control of 45 tons per
14
year. Because of the cost associated with
15
VOM control for this type of equipment, it is
16
impractical to add control. So effectively
17
the limits before control is required act as
18
upper limits on the air emissions from the
19
seven units. The actual emissions from these
20
units vary year to year based on the quantity
21
of production and based on the different
22
materials produced. In recent years the
23
tunnel dryer emissions have varied from
24
six-tenths of a ton to 5.6 per year, each
26
1
year. Fluid bed dryer emissions have varied
2
from .1 tons to 3.9 tons per year each where
3
the units have been operating. And you can
4
see from Exhibit 3 that's where those numbers
5
came from, although they were not in my
6
pre-filed testimony.
7
Abbott sought solutions to
8
eliminate manufacturing constraints that
9
effected the efficiency of the overall
10
operation, and two options were initially
11
considered. One be would be to request an
12
increase in the threshold that would have to
13
be exceeded before control were required, and
14
the second would be to refine Subpart-T so
15
that the individual unit control would be
16
applied as a group to the combined emissions
17
of the combined allowed emissions of the
18
seven dryers. We evaluated the alternatives,
19
and we did some analysis that demonstrated to
20
us that it would be justifiable to increase
21
the limit for each dryer, that the cost of
22
control was such that at the levels that the
23
threshold of requiring control and at higher
24
levels, that the cost would be beyond
27
1
reasonably available control technology or
2
RACT.
3
Considering the combined emission
4
controlled threshold, we determined that the
5
flexibility that we were looking for would
6
fit well within that so that there was -- we
7
could go forward with that program without
8
increasing the allowable emissions from the
9
units. We discussed these alternatives with
10
Illinois EPA and later with both IEPA and US
11
EPA through our attorneys Hodge Dwyer Zeeman.
12
And IEPA and US EPA identified a third
13
alternative that was preferable to them and
14
that was a source specific emission cap,
15
SSEC, under US EPA's economic incentive
16
program or EIP. The source specific emission
17
cap would allow us to combine our future
18
emission limits for all the dryers but set to
19
a limit below the historical actual emissions
20
rather than the previously allowable
21
emissions or emissions allowable without
22
control. The historical emissions could be
23
based on a concept called baseline actual
24
emissions defined as the highest two year
28
1
period in the last ten years. I know there
2
was some confusion about that following my
3
filing of the pre-filed testimony and we're
4
prepared to answer that question in detail
5
when we go through the prepared questions.
6
This is a change from the original definition
7
of historical actual emissions that the US
8
EPA included in their 2001 guidance. Abbott
9
reviewed the actual emissions that we've had
10
from the dryers in the most recent ten years,
11
and we identified the maximum two-year period
12
with emissions of 22.9 tons per year in 1999
13
and 2000. As I'll discuss later, a reduction
14
of ten percent of that level is applied to
15
insure environmental benefit and that results
16
in an emission limit for the seven units of
17
20.6 tons per year. This restriction would
18
be less than half of the 45 ton per year
19
effective limit that now applies to the seven
20
units taken together. This significantly
21
lower allowable limit though is acceptable to
22
Abbott's anticipated business and meets our
23
needs for flexibility.
24
Abbott considered the requirements
29
1
of the EIP program in going forward with this
2
in order to define our conformance with the
3
three general principles for an EIP,
4
integrity, equity and environmental benefit.
5
Integrity, the integrity principle focuses on
6
the emission reductions themselves and
7
requires them to be surplus, bonafiable,
8
enforceable and permanent. This proposal
9
satisfies those conditions. The emissions
10
are surplus because our future allowable
11
emissions will be below past baseline
12
emissions for the dryers. Our emissions are
13
quantifiable because the VOM emissions can be
14
readily calculated from process record
15
keeping as established in the facility's
16
title five permit. The limits are
17
enforceable because they will be included in
18
Illinois's state implementation plan and also
19
in our Title V permit for Abbott Park and
20
they are permanent for the same reason. They
21
will be established as continuing limits on
22
our operations.
23
The proposed program satisfies the
24
equity principle because it involves only
30
1
emissions at one facility. There is no
2
instance of relative increases and decreases
3
that must be balanced against one another.
4
The program satisfies the environmental
5
benefit principle because future emissions
6
will be reduced by ten percent below our
7
baseline actual emissions.
8
So in summary, the proposal limits
9
our maximum future allowable emissions to a
10
level below what we historically had really
11
in the course of the variations in our
12
manufacturing, but it will give us the
13
flexibility to operate more efficiently.
14
Thank you. I'll be happy to
15
answer any further questions.
16
MS. HODGE: Thank you very much.
17
We're ready to move on to the Board's
18
questions unless counsel for Illinois EPA has
19
anything now?
20
MS. CROWLEY: If we could first mark
21
as Exhibit No. 5, the pre-filed testimony
22
submitted by Mr. Wells on February 22nd, as
23
I'm sure he would like the complete testimony
24
included in this record.
31
1
MS. HODGE: Yes, he would.
2
MS. CROWLEY: We will do that.
3
MS. HODGE: Now, we'll turn to the
4
questions of the Board that were included in
5
the hearing officer order dated March 4,
6
2008.
7
MS. CROWLEY: And let's mark that as
8
Exhibit 8.
9
MS. HODGE: And we're not going to
10
read the questions. We'll just go straight
11
to the answers, if that's acceptable.
12
MS. CROWLEY: Unless you are more
13
comfortable having us read the questions, we
14
can dispense with that.
15
MS. HODGE: Okay. Then we'll probably
16
answer the questions certainly in order. And
17
No. 1, we'll start with --
18
MR. WELLS: Question 1-A refers to
19
whether the economic feasability for the
20
original rule making still applies? The
21
answer to that is yes. As a part of this
22
process we analyzed the cost of control using
23
a methodology developed by the United States
24
EPA for what's referred to as BACT analysis,
32
1
Best Available Controlled Technology, and
2
using this analysis we found that the cost of
3
control was continued to be significantly in
4
excess of what's normally considered
5
reasonably available control technology. So
6
essentially the economics have not changed.
7
And as to question 1-B, there have been no
8
fundamental changes in emission control
9
technology that would be applicable to the
10
facility since that original rule making. So
11
what we were looking at were the same control
12
technologies that were considered at that
13
time.
14
MEMBER RAO: We're fine with that.
15
MS. HODGE: Thank you. And let's move
16
on to the Board's question No. 2 dealing with
17
emission trends.
18
MS. BENO: Okay. 2-A is in regard to
19
the lower actual emissions since 2000.
20
That's due to many factors. For example,
21
pharmaceutical manufacturing business
22
activity is highly variable year over year.
23
The types of products that we produce in a
24
given year can vary based on a number of
33
1
market factors and patient demand. So
2
therefore, as I stated in the testimony,
3
different products emit different levels of
4
VOM. So product mix is a primary factor in
5
regard to the variability of our emissions.
6
MEMBER RAO: Has there been any change
7
in terms of production itself because when we
8
look at this, we see some variation but there
9
is also a significant, you know, reduction in
10
VOM emissions since 2000?
11
MS. BENO: As stated in the testimony
12
many new products where possible utilize
13
water based massing fluid, and so we make an
14
attempt using water instead of ethanol or
15
other VOM. So therefore the new products
16
that have been introduced to the facility
17
typically have used water based solvents.
18
MEMBER JOHNSON: And there's no VOM
19
produced when you use water as a fluid?
20
MS. BENO: No, no.
21
MEMBER RAO: Do you anticipate VOM
22
emissions to increase over time?
23
MS. BENO: We don't anticipate them to
24
increase over time.
34
1
MEMBER MELAS: I have a question. You
2
stated earlier that the fluid bed drying is a
3
more efficient way of doing it. Do you
4
contemplate over the course of time now that
5
you will be phasing out the tunnel drying
6
equipment and concentrate on buying or
7
purchasing new fluid drying equipment?
8
MS. BENO: No, that's not currently
9
the plan. In fact, the products that we
10
manufacture in the tunnel dryers, we will
11
continue to manufacture those in the tunnel
12
dryers. To switch between the technologies
13
can have an impact on the safety or efficacy
14
of the drug product. So it would require a
15
lengthy amount of process development and
16
studies potentially, even clinical trials, so
17
that is the lengthy FDA process I referred
18
to.
19
MEMBER MELAS: You say there is a
20
one-on-one relationship to the type of
21
product to the type of dryer?
22
MS. BENO: Yes, absolutely.
23
MEMBER JOHNSON: Let me ask then.
24
There is then in your mind a potential any
35
1
way that your company will begin some time in
2
the future to manufacture products that
3
either can't use the water as a massing fluid
4
and have to use ethanol; there is a potential
5
that you'll get back up to VOM rates
6
comparable to what they were in '99 and 2000?
7
MS. BENO: I wouldn't rule it out. It
8
certainly wouldn't be our intent, but I
9
wouldn't rule out the possibility.
10
I'll move on to B?
11
MS. HODGE: Yes.
12
MS. BENO: B is in regard to tunnel
13
dryer number four specifically, and in
14
Exhibit 3 it was noted that there was no VOM
15
from tunnel dryer three since 2005, and based
16
on Abbott's production needs, tunnel dryer
17
No. 4 has not been in use since 2005.
18
However, it remains fully validated and
19
maintained and available for use should
20
production needs demand. So it serves us as
21
a back up in the event that one of the other
22
tunnel dryers would become unavailable for
23
use.
24
MEMBER RAO: Since the emissions for
36
1
all these dryers that you have listed in
2
revised Exhibit 3 are significantly lower
3
than the applicable limits, does Abbott have
4
enough flexibility under the current rule
5
itself or do you need to have the combined
6
limit to provide you that flexibility?
7
MS. BENO: We believe we need the
8
combined limit to provide flexibility.
9
MEMBER RAO: Can you explain a little
10
more why, if you don't have enough
11
flexibility under the current rule?
12
MS. BENO: It's based on the highly
13
variable nature of the product mix in the
14
facility. So in the event we were to run
15
more or some the products that have an
16
ethanol based mass in fluid, it would prevent
17
us from using the most effective and
18
efficient equipment.
19
MEMBER RAO: Have you had that kind of
20
situation in the past?
21
MS. BENO: What specific situation?
22
MEMBER RAO: Where you were not able
23
to use whatever dryer you wanted to under the
24
current rules.
37
1
MS. BENO: It's become very close.
2
MEMBER RAO: Looking at this data that
3
you have provided, fluid bed dryer 3
4
obviously could be the one which is kind of
5
closer to its limit?
6
MS. BENO: Right.
7
MEMBER RAO: Is that a situation where
8
you see and you'd need to use another dryer
9
similar to that again?
10
MS. BENO: Yes, absolutely. Fluid bed
11
dryer 3 in Exhibit 3, as you noted, has
12
reached 3.9 in recent years which approaches
13
our current limit.
14
MEMBER RAO: Thank you.
15
MS. HODGE: Let's move on to the
16
questions in the Board's order relating to
17
the pre-filed testimony of Ms. Beno, and
18
question No. 1.
19
MS. BENO: This is in regard to the
20
type of organic massing fluid that we
21
currently use, and ethanol has been the only
22
organic massing fluid that we've used in
23
building AB16 during the ten-year period
24
under review for this proposal. I do want to
38
1
note that prior to late 2002 the type of
2
ethanol used was denatured ethanol which
3
contains a small percentage of methanol as
4
the denaturant, but since late 2002 we've
5
converted to all beverage grade ethanol which
6
does not contain methanol as the denaturant.
7
MS. HODGE: Question number two?
8
MS. BENO: Again, number two is in
9
regards for the basis for choosing the
10
massing fluid, and the choice of massing
11
fluid is dependent on the particular
12
properties of a product. For example, the
13
relative solubility of the product in either
14
water or ethanol plays a key role in
15
determining which solvent will be required
16
for the massing fluid. So it's really
17
related to the various properties of the
18
product we're intending to manufacture
19
whether or not water is an option for us or
20
not.
21
MEMBER RAO: So it's got nothing to do
22
with the type of dryer you are using; it's
23
all the product you are manufacturing?
24
MS. BENO: No, either can be used in
39
1
either dryer. Water or ethanol can be used
2
in either drying technology.
3
MS. HODGE: Question number three?
4
MS. BENO: No. 3, this is in regard to
5
increased use of fluid bed dryers and water
6
for massing fluid. Abbott does in fact
7
expect there will be an increased mass for
8
water in new products as I indicated. It's
9
not practical to change the ethanol based
10
processes to a water based process because of
11
the FDA considerations that I indicated
12
before had the opportunity to influence the
13
safety and efficacy of the product. But we
14
do consider the type of massing fluid as we
15
developed new products with a preference to
16
using water. So accordingly we expect there
17
will be an increased use of water for the
18
massing fluid for new products. Questions
19
there?
20
B, this is in regard to the use of
21
water to avoid VOM emissions. And in fact
22
VOM emission avoidance is one of several
23
factors that we consider as one of the
24
benefits resulting from increased use of
40
1
water for the massing fluid. Other benefits
2
include increased raw material costs, reduced
3
worker exposure to organic materials in the
4
work place and improved safety due to
5
reduction of flammable solvents.
6
In regard to C, water based
7
products are preferable for a number of
8
reasons. As described previously, they are
9
preferable because they don't contribute to
10
VOM emissions, reduced raw material costs,
11
reduced worker exposure and improve overall
12
safety to the facility. Those were similar
13
questions.
14
In regard to the fluid bed dryers
15
being more efficient, it's mainly related to
16
the way they operate. If you refer to the
17
diagram, you can see in a fluid bed dryer,
18
individual granules, very small pieces of the
19
product are airborne in the warm air stream
20
and the air moves around freely on all
21
surfaces of the particle or granule drying
22
the drying process. This results in a much
23
more even drying process and higher quality
24
end product because of the evenness of the
41
1
drying. Tunnel dryers on the other hand are
2
like cookie sheets in an oven. You hand-load
3
the material onto the cookie sheet, onto the
4
big rack, push the rack into the tunnel dryer
5
and it's exposed to air movement in the
6
tunnel. What can happen in a tunnel dryer
7
similar to in baking, you could have parts of
8
the cookie that are more done than other
9
parts of the cookie. Whereas in the fluid
10
bed drying technology, a smaller portion of
11
the product is exposed to the warm air across
12
the entire surface. So it makes for a much
13
more uniform drying process which makes the
14
downstream processing much easier.
15
MEMBER RAO: I think you answered 4B
16
already.
17
MS. BENO: Yes, yes. Thank you.
18
MS. HODGE: Number five?
19
MS. BENO: Selection of the dryers.
20
One example of the inefficiencies created by
21
the current rule is that the most
22
appropriately sized equipment may not be
23
chosen. As I mentioned in the testimony, we
24
have small scale process trains and large
42
1
scale process trains. Now, in the event that
2
the small scale process train would be
3
approaching its limit, we may be forced to
4
use the large scale process train to process
5
smaller batches than would normally be
6
processed in that particular process train.
7
So that is the main consideration in regards
8
to inefficiency of the scheduling that could
9
be influenced by the current rule. It's much
10
like flying a plane half full or running a
11
dishwasher half full, you are not utilizing
12
the full capacity of the equipment in that
13
particular area.
14
MR. RAO: In this regard, I didn't see
15
any information about the drying capacity of
16
these dryers. Are they all about the same or
17
each dryer is different.
18
MS. BENO: It has to do with the
19
processing suits that they are in. We have
20
one dryer in one processing suit, and we have
21
two dryers in another processing suit.
22
That's our large scale processing train
23
versus our small scale processing train. As
24
I mentioned, you can only run one product in
43
1
a process train at any given time.
2
MEMBER RAO: Thank you.
3
MS. BENO: So there was one final
4
question regarding how we select which dryer
5
to use for a given campaign. And the
6
selection of dryers is mainly based on the
7
technology first. As I mentioned there is a
8
one to one relationship of which product goes
9
in which type of technology. Meaning a
10
tunnel dryer or a fluid bed dryer. The
11
second consideration would be the scale,
12
whether it's a large scale batch or a small
13
scale batch, and then the third consideration
14
is general availability; do we have more
15
products running in one size suit than the
16
other or is one of the suits down for
17
maintenance or cleaning. So those are the
18
critical factors that we consider when
19
scheduling the production in the dryers.
20
MEMBER RAO: Thank you.
21
MEMBER JOHNSON: The amount of VOM
22
produced is dependent upon the amount of
23
ethanol, use not on your choice of which
24
drying --
44
1
MS. BENO: Absolutely because we're
2
going to be drying to the specification of
3
the product so we'll always be drying off the
4
same amount of VOM for a given product for a
5
given batch.
6
MS. HODGE: Thank you. Anything else?
7
MS. CROWLEY: Mr. Matoesian, have you
8
had any questions?
9
MR. MATOESIAN: No, not so far.
10
MS. CROWLEY: I've been keeping an eye
11
on you, but I just wanted to state it for the
12
record.
13
MS. HODGE: Let's move on to the
14
questions of the pre-filed testimony of
15
Mr. Wells.
16
MR. WELLS: I talked briefly earlier
17
about the two-year period. What has happened
18
is that there has been a change in philosophy
19
on the conceptual level in US EPA's
20
application of historical emissions.
21
The definition of historical
22
actual emissions that appears in the 2001
23
guidelines, the US EPA developed is the same
24
as the concept in prevention of significant
45
1
deterioration, PSD, or non-attainment new
2
source review, netting that US EPA has
3
previously used and what was in place at the
4
time; that is , the two years immediately
5
preceding the action or another two year
6
period, if it's determined to be more
7
representative. There's been a lot of
8
problems historically in the determination of
9
whether a particular period is
10
representative, and the US EPA in 2002
11
changed the definition of actual emissions.
12
They defined a term "baseline actual
13
emissions" for the PSD and the non-attainment
14
new source review program. And what they
15
said was that you can use any 24-month period
16
in the preceding ten years. That assures
17
that you can look back far enough to see a
18
representative business cycle so that you can
19
see the periods when your normal fluctuation
20
of business would result in relatively higher
21
emissions. But at the same time it gives a
22
simple concrete basis to make that decision.
23
That was originally suggested to us in the
24
conversations that our attorneys had with
46
1
IEPA and with US EPA. That was the
2
recommended interpretation at the time, and
3
as we understand it, US EPA guidance is now,
4
their guideline on the EIP process, which is
5
not a regulation. It is guidance, is being
6
interpreted differently to allow the use of
7
that two-year period as far back as ten
8
years. I'll also point you to the revised
9
Exhibit 3. If you notice, 1999 and 2000 were
10
the highest years. 1998 was actually lower
11
than the emissions in either 1999 or 2000.
12
So it is in fact a peak that we are talking
13
about rather than just a continuing decline.
14
MEMBER RAO: And, Mr. Wells, do you
15
have any specific US EPA publication or
16
memorandum that talks about this change in
17
their policy?
18
MR. WELLS: Well, the baseline actual
19
emissions were established in a federal
20
register notice amending the PSR rules at 67
21
Federal Register 80.186.
22
MEMBER JOHNSON: We, as good corporate
23
citizens, it's to your benefit to keep your
24
VOM emissions as low as possible, but what
47
1
you want to be able to do, at least I take it
2
is, that the demand for whatever product you
3
are producing in 1999 and 2000 were to return
4
and you had to use the same drying system or
5
use the ethanol rather than water on that to
6
develop that or make that particular product,
7
you want to be covered so that you can do
8
that and fulfill the demand. And that's why
9
even though these VOM emissions are at least
10
twice as much as the next five years, that's
11
why you want to have that set as your
12
baseline?
13
MR. WELLS: Exactly.
14
MS. HODGE: And, again, just to note
15
for the record, that historical baseline is
16
being reduced by ten percent, you know, in
17
the limit that we're requesting.
18
MEMBER JOHNSON: And in fact, the
19
reduction from what it is now is
20
significantly more than that. If you ran all
21
of your dryers at capacity, you would produce
22
45 tons, and this site specific rule as
23
proposed reduces that by over 30 tons, right?
24
MEMBER RAO: Half.
48
1
MR. WELLS: Over half, a little over
2
half.
3
MEMBER RAO: Thank you.
4
MR. WELLS: Question two, I think it
5
kind of follows question one.
6
MS. HODGE: We're good there. Shall
7
we move on the economic incentive program
8
guidance? Question No. 1. And this is
9
something that we thought might be more
10
properly addressed to the Illinois EPA.
11
MR. MATOESIAN: That's fine. Charles
12
Matoesian speaking. With me today I have
13
Mr. Yoginder Mohajan (Phonetic), who is an
14
engineer with the Illinois Environmental
15
Protection Agency, he is here to answer some
16
questions from the board. He is currently in
17
the air quality planning section of the
18
Bureau of Air and has prepared some answers
19
for these questions.
20
MS. CROWLEY: Would you swear him in?
21
YOGINDER MAHAJAN
22 having been first duly sworn, was examined and
23 testified as follows:
24
Question No. 1 on page three, the
49
1
guidance states that the guidance applies if
2
state applies --
3
MS. CROWLEY: Off the record.
4
(Discussion off the record.)
5
MS. CROWLEY: Go back on the record.
6
MR. MAHAJAN: The answer to the
7
question, I spoke with the US EPA, Mr. Steve
8
Rosenthal. He told me that the option of the
9
EIP is not required. It is recommended. It
10
is nice if you have it adopted, but it's not
11
required and the agency's intention is not to
12
adopt it. It will deal with it on a case by
13
case basis.
14
Question No. 2, yes, the agency
15
has discussed this with the US EPA and
16
confirmed that this amendment is consistent
17
with the EIP guidelines.
18
No. 3, yes. And question No. 3B
19
is also no. Regarding emissions being
20
surplus is there any concern? No we don't
21
have any concern. It's discussed with the US
22
EPA, and they said that it is consistent with
23
the EIP guidelines.
24
MEMBER RAO: Thank you.
50
1
MS. HODGE: Do you have any other
2
questions?
3
MEMBER RAO: There was one question
4
about the proposed amendment.
5
MS. HODGE: We're ready to move to
6
that.
7
MEMBER RAO: No follow-ups.
8
MS. CROWLEY: Do you have any
9
follow-ups for this.
10
MS. HODGE: No. So we'll move on to
11
the question on the proposed amendments,
12
question No. 1.
13
MR. WELLS: Yes. The only concern
14
that we had with the specification of the
15
equipment was that we not specify that --
16
28.480(b) now covers the entire facility,
17
more than just building AB16. We would not
18
have a problem if the specification were made
19
on the SSEC that we've been discussing today.
20
As far as specifically 218.480(b)(4), as far
21
as the general applicability of 218.480(b),
22
it's our understanding that still applies to
23
the facility, and it is possible that we
24
might find the need to install a fluid bed
51
1
dryer in another building for a totally
2
unrelated manufacturing process.
3
MEMBER RAO: You are comfortable with
4
the way the rule is proposed now?
5
MR. WELLS: That's correct.
6
MEMBER RAO: I think that question was
7
triggered because the way 218.480(b) is now
8
currently written, Abbott's name is not
9
mentioned in that section at all. And I know
10
it's highly unlikely that somebody else would
11
set up shop with four dryers and give them
12
names and take advantage of this rule, but in
13
most of our site specific rules we have the
14
name of the company involved in it. So I
15
just wanted to know what your thoughts were
16
on it.
17
MR. WELLS: In terms of identifying
18
the company, I don't think we have any
19
objection to it. The drafting of the
20
original rule was before my time. I'm not
21
sure where the language came from, but that
22
wouldn't be a problem. Again, the only thing
23
we wanted to be sure was that it wasn't
24
defined specifically to cover building AB16,
52
1
just to allow us the same flexibility in the
2
future.
3
MEMBER RAO: Okay.
4
MEMBER JOHNSON: The road is named
5
after you so --
6
MEMBER RAO: Thank you very much.
7
MS. HODGE: Thank you.
8
We have one more issue that we'd
9
like to address, and this deals with a
10
request that has been made by US EPA through
11
the Illinois EPA, and they had asked if we
12
could submit to them some of the supporting
13
emission calculations for the baseline years,
14
1999 and 2000. We've talked with IEPA about
15
how the emissions are calculated and US EPA
16
wants a little bit more information. We are
17
currently preparing that, and we will submit
18
additional information in response to that
19
request subject to CBI, confidential business
20
information requirements on that. So that
21
will be forthcoming, and I understand from
22
talking with counsel for IEPA, that you would
23
like to have some of that in this board's
24
record, that IEPA would like to have some of
53
1
that in the Board's record.
2
MS. CROWLEY: I understand that.
3
Please if any of it is confidential business
4
information or trade secrets, that when it is
5
submitted that it is properly submitted with
6
a redacted copy, as well as the copy that you
7
would like to have protected so that there
8
isn't any problem with that.
9
MS. HODGE: We can do that, and we
10
will work with IEPA and Mr. Steve Rosenthal
11
at US EPA to make sure that everyone is
12
comfortable with what we submit.
13
With that, I don't have anything
14
else.
15
MR. MATOESIAN: We have nothing.
16
MS. CROWLEY: One little left over bit
17
was the motion to file the amendment, Exhibit
18
3, and the motion to amend the proposal
19
specifically as it regards proposed
20
218.480(b)(4) to reflect the change to the 90
21
percent baseline calculations. Do you have
22
any objection to that?
23
MR. MATOESIAN: No.
24
MS. CROWLEY: Thank you. That motion
54
1
then is granted. Let's go off the record for
2
a moment.
3
(Discussion off the record.)
4
MS. CROWLEY: Back on the record. We
5
have had a brief discussion about what would
6
be a reasonable post-hearing comment period.
7
We have chosen May 1st as the close comment
8
period date subject to an extension if
9
necessary to allow completion of data
10
gathering for US EPA or if any other person
11
needs additional time. We specifically do
12
request that the agency file, even if short,
13
some comment on this record indicating their
14
view of whether this rule should or should
15
not be granted. If there is nothing else --
16
MR. MATOESIAN: We can say, the Agency
17
can state that it supports the petition.
18
MS. CROWLEY: Okay, fine. If there's
19
nothing else then, I thank you all for your
20
participation. The Board again thanks Abbott
21
for its patience in bearing with our
22
scheduling problems. We will try to render a
23
decision in an expedited fashion once the
24
record is closed. Again, thank you all very
55
1
much.
2 STATE OF ILLINOIS )
) SS.
3 COUNTY OF COOK )
4
5
I, DENISE ANDRAS, being a Certified
6 Shorthand Reporter doing business in the City of Des
7 Plaines, Illinois, County of Cook, certify that I
8 reported in shorthand the proceedings had at the
9 foregoing hearing of the above-entitled cause. And
10 I certify that the foregoing is a true and correct
11 transcript of all my shorthand notes so taken as
12 aforesaid and contains all the proceedings had at
13 the said meeting of the above-entitled cause.
14
15
16
___________________________
17
DENISE Andras, CSR
CSR NO. 084-003437
18
19
20
21
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