BEFORE THE ILLINOIS
POLLUTION CONTROL BOARD
IN THE TTER
OF:
ABBOTT LABORATORIES' PROPOSED )
SITE-SPECIFIC AMENDMENT TO
)
APPLICABILITY
SECTION OF ORGANIC )
MATERIAL EMISSION STANDARDS
AND )
LIMITATIONS
FOR THE CHICAGO AREA; )
T: PHARMACEUTICAL
)
MANUFACTURING (35 ILL. ADM.
CODE )
218.480(b))
)
NOT
TO: Mr. John Therriault
Assistant Clerk of the Board
Illinois Pollution
Control Board
100 West Randolph Street
11-500
OF
R 08-8
(Rulema
ING
Kathleen M.
Crowley,
Esq.
r
Illinois Pollution Control Board
100 West Randolph
Street
Suite 11-500
go, Illinois 60601
D SERVICE LIST)
AIL)
TICE that I have today filed with the Office of the
Clerk of
oard ABBOTT LABORATORIES' POST-
Respectfully submitted,
By: /s/ Katherine D. Hoda
Dated: May 1, 2008
Katherine D. Hodge
Lauren
C.
Lurkins
HODGE DWYER ZEMAN
3150 Roland Avenue
ox 5776
1linois 62705-5776
THIS FILING SUBMITTED
4N
RECYCLED PAPER
Electronic Filing - Received, Clerk's Office, May 1, 2008
* * * * * PC 2 * * * * *
CERTIFICATE OF SERVICE
I, Kather
e undersigned, hereby
certify that I have served
ABBOTT LABORATORIES' POST-HEARING
COMMENTS upon:
herriault
Assistant
Clerk of the Board
Illinois Pollution Control Board
100 West Randolph Street
Suite 11-500
Chicago, Illinois 60601
electronic mai on May l, 2008; and upon:
Kathleen M. Crowley, Esq.
Hearing Officer
Illinois Pollution Control Board
100
West
Randolph
Street
60601
D ivision of Legal Counsel
Illinois
, Illinois 62794-9276
Matthew
J.
Dunn,
Esq.
Chief
Environmen
Office of the Attorney General
69 West Washington
Street, Suite 1800
Chicago, Illinois 60602
Office
of Legal
Services
nois Department of Natural
Resources
One Natural Resources Way
is 62702-1271
by depositing said document in the United States Mail, postage prepaid, i
Illinois
on
May l, 2008.
A BOT:003/Filings(NOF & COS, Post-Hearing Comments
Electronic Filing - Received, Clerk's Office, May 1, 2008
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BEFORE THE ILLINOIS
POLLUTION CONTROL BOARD
IN THE
MATTER OF:
ABBOTT LABORATORIES'
PROPOSED )
R08-8
SITE-SPECIFIC AMENDMENT TO
) (Rulemaking
-Air)
LITY
SECTION OF ORGANIC
SIO
IONS FOR THE CHICAGO AREA;
SUBPART T: PHARMACEUTICAL
)
MANUFACTURING
(35 ILL. ADM. CODE )
218.480(b))
)
ABBOTT LABORATORIES' POST-HEARING
COMMENTS
NOW COMES ABBOTT LABORA ORIES
ugh its
attorneys, HODGE
DWYER ZEMAN, and hereby provides the Illinois Pollu
Board ("Boar
h the following post-hearing comments.
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
8 of the Illinois Environmental Protection Act ("
and 28), 35 Ill. Admin. Code § 102.2 10 and 35 111. Admin.
Code § 102.202
with regard to emissions froth c
) to allow it
aceutical manufacturing facility located
in
Libertyville
Township, Lake County, Illinois ("Facility"). As part of its initial filing, Abbott also
submitted motions requesting the Board to waive the requirement
for
200
signatures on
oposal and to expedite consideration of its request by, among other things, ordering
ion of the rules for first notice under the Illinois
Administrative
0/1-1).
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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 Require
t o Submit 200 S
e s. In the same Opinion and
Order, the Board denied Abbott's
Motion for Expedited
Review, but authorized first-notice publication without corn
on the merits of the proposal.
On February 22, 2008, Abbott
submitted the Prefiled Testimony of Diane Bern in
Support of Propos
Wells
pecific Amendment and the Prefiled Testimony
of
Robert
C.
sed
Site-Specific Amendment. On February 29, 2008, Abbott
filed
its Motion to File Revised Exhibit 3 and Minor Revision to Proposed Subsection
218.480(b)(4),
ich. Abbott sought to make the following changes to Exhibit
3 1 that
proposal: 1) correct a typographical error for the 1999 total,
of the baseline,
at 2 decimal places; 3) add a line for 90%
corrected value of 20.6 tons per year; 4) add Note c to identify
significant figures; and 5) update the reference in.
correct condition in
the renewed Clean Air Act Permit Program ("CAAPP") Permit, issued on September 2
2007. Abbott also sought to file a minor revision to its proposed ame
218.480(b) to reflect the change made to the 90% baseline calculations, as follows:
n
o
ne additional clarification may
be needed for the revised Exhibit 3. Specifically, upon
compilation
of the emission
calculation data requested
by USEPA and
Illinois
EPA after the hearing in this
matter, it was noted. that one small run with VC)M emissions was conducted in fluid bed dryer # 3 in July of
1999. This run resulted in 0.0326 tons (65 pounds) of VCJ.M emissions. These
emissions were not included
ibit 3 due to the rounding of values in the original Exhibit. The additional 65 pounds of
emissions do not change the indicated total 1999 emissions, the 2-year emission total,
or
proposed
.
e the seven dryers (90 percent of baseline), which are each stated to the nearest 0.1 ton per
ised Exhibit 3.
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s subsection 218.480(b)(4) shall not exceed
4S318,6
kg/year 2-077
20.6 tons/year). r BOARD NOTE: tunnel dryers are
otherwise referred to as warm air drvers , and
A hearing was held in Libertyville on March 7, 2008
("Hea
with
representatives
of both the Illinois Environmental Protection Agency ("Illinois EPA")
and Abbott in attendance.
ROPOSAL
As explained more fully in Abbott's proposal and at the Hearing, Abbott produces
ical products at the Facility, and these
operations are subject to 35
de Subpart T - Pharmaceutical Manufacturing ("Subpart T"). As currently
Subpart T contains certain exemptions that are only
Abbott's air suspens
ction 218.
Accelacotas located at the Fac
he
overal.
dryer, fluid bed dryers, tunnel dryers and
Abbott is proposing to amend these site-specific
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
sions. If adopted, the proposed amendment would reduce the overall
allowable emissions from these
gard to these units.
III. DISCUSSION
while increasing
response to questions of the Board. Abbott
ott's operational flexibility
3
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plant manager at Abbott's Building AP 16; and Robert C. Wells, Air Manager for
resented one
witness: Yoginder Mahajan, an Engineer with the Air Quality
mental Support in Abbott's
Global
Environmental
Health & Safety Department.
Illinois EPA Bureau of Air.
Facility, Abbott produces intermediate
and final
A.
rocess and Affected Emission U
In Bui
pharmaceutical product formulations. Pre-Filed Testimony
of Diane Beno ("Reno") at 1.
bott manufactures its
roduct
roducts using batch production processes. Beno at 2. In batch
of the processing equipment in a process
manufactures
one product at a time. Beno at 2. In a typical process, the active and
inactive
mbined with a liquid in a process called "massing." Beno at 2.
ifonn
yers 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
fitted to the ambient air as volatile organic material ("VOM")
or volatile
organic compounds. Beno at 2. The quantity of VOM emissions will vary for different
products,
and
is
calculated from the quantity of VOM 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 of tunnel dryers, materials
to be
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dried are spread
on trays and placed in a warming c
warm air over and under the trays. Beno at 3.
or "tunnel" that circulates
A fluid bed dryer is a large
vertical cylindrical shaped vessel with a diffuser
that
blows
warm air up from the bottom of the vessel. Beno at 3. The
wet intermediate
granules are loaded into the dryer and flow upward, suspended
in the warm air stream.
Beno at 3. Abbott has increased its use of fluid 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 of water for the massing fluid
in future products. Beno at 3. Abbott expects that this preferential
use of fluid bed
dryers
oat3.
Batches of specific products are typically manufactured u
rocess train to manufacture certain products from
cause the technologies are
changeable. Beno at 3. Individual dryers of the same type can typically be used
geably in
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 determining
which
of the dryers
will be
most
efficient.
Beno at 4. Additio
d between batches
different products, resulting in up to three days of lost production
o
ne
or
more
4 .
egy to continue running batches of the same
product consecutively in the process train to minimize this cleaning time. Beno
at 4.
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e
VOM limit on each individual dryer.
Beno at 4. To ensure compliance
with
2-month total VOM 1
18.480(b) effectively
defines a 12-month total
mit on each dryer, for a particular
batch, Abbott may be
d to utilize a dryer
with
low
VOM emissions during the last 12 months
using the dryer that is the
most efficient from a production-scale standpoint.
Beno at 4.
Additionally, the dryer selected for a given campaign
als
factors, such as scale a
and other factors. Beno
at
4-5.
Therefore, the standards, as currently defined,
can
result
butt to dry a small
batch of product
rocess train to maintain our equipment-specific
VOM limits. Beno at 5.
Total annual emissions from a dryer result from the quantity of organic
solvent
removed from the different products processed in
a dryer over a rolling 12-month period.
The assignment of a campaign of a pa
effic
g factor that can force a particular production
campaign
ds on dryer availability
ilability, that
. Beno at 5. The VOM emission threshold
with VOM emissions to be scheduled
using equipment that has low enough recent
o avoid exceed
or most efficient equipme
er threshold, but that may not otherwise be the op
e campaign. Beno at
5.
This
scheduling shift increases
the operational cost, but results in n
will be the same as if the campaign would have used the op
environmental benefit, because the actual emissions
e current
ad of
oats.
lity remains competitive with its national and
global competitors, Abbott must continually seek ways
of
roduct to one or more dryers
ns more efficient. Beno
at 5.
The
scheduling inefficiency created by Subpart
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ntifled as one area where improvements in efficiencv could be made and
is the
basis for the proposed amendment. Beno at
5.
The
most efficient method to manufacture Abbott's
would be to use the dryer that is
best suited to the
ntly lowering the total allowed VOM emissions from all
the
schedule
and scale, regardless of the amount of VOM that has been emitted from that
dryer in the past 12 months. Beno at 6. Provided that the combined
VOM emissions
from all
of the dryers are less than the combined amount allowed under Section
218.480(b), this method of operation would not require an increase in allowable VO
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 signi
Applicable I2e uirements and Actual Emissio
annual emissions exceed 7.5 tons per year ("ton/yr") for a tun
n/yr for a
. 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. Becau
type of equipment,
oducts in Building AP 16
nts of the produc
ciated
with
VOM
control for this
ctical to add control. Tr. at 25. Thus, the limits app
before control is required effectiv
r 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 of the overall operation with Illinois EPA and
USEPA. Tr. at 27.
Illinois E
d USEPA identified
an alternative that was preferable to them called a
Source
Specific
Emissions
Cap ("SSEC") Economic Incentive Program ("EIP"), as
identified in the USEPA Office of Air and Radiation's EIP guidance
document entitled
Improving
efined as the highest two-year period in the
anuary 2001). Tr. at 27. The SSEC would allow Abbott to combine its future
emission
ers and establish a limit below the historical actual emissions, rather
trol. Tr, at
27.
Under
such an approach, the historical
emissions would be based on a concept called
"base
r 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
2000. Tr. at 28. That amount was then reduced by
cent to ensure environmental benefit and
resulted in
an emission limit of 20.6
h Economic Incentive Programs, Doc. No. EPA-452/R01-001
dryers. Tr. at 28. This emissions limit would be less than half of the
45 ton/yr effective
to the seven dryers
taken together. Tr. at 28.
ificantly lower allowable limit is acceptable to Abbott's anticipated business and
s. Tr. at 28.
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In going
forward with the SSEC EIP approach, Abbott considered its
conformance with the three general principles of an EIP: 1) integrity; 2)
equity; and 3)
at 28-29. Abbott is
confident that its proposal satisfies all of
the general EIP principles. Tr. at 29-30.
D.
Questions
of the Board
Addressed at Hearintj
No members of the public attended the Hearing. Tr. at 4. At the Hearing, the
g Officer asked Abbott to address the questions of the Board
that were included in
8.
the following testimony was provided by Abbott for the Board's cons
hose questions,
ation.
The Board's Statement of Reasons Question I (a) referred
to whether the
information presented in the R86-10 rulema
egarding economic feasibility of
controlling emissions from Abbott's tunnel dryers and fluid bed
response, Mr. Wells stated th
s. Tr. at 31. As part of the rulema
analyzed the cost of control using a methodology developed by
valid. In
ocess, Abbott
Abbott found that the cost of control continued to be significantly
e BACT analysis,
ed Reasonably Available Control Technology. Tr. at 32. Essentially,
the economics have not changed since the R86-10 rulemaking. Tr. at 32.
I (b) asked whether there has been any
ons control technology since the adoption of the original rules. In
Mr. Wells stated that there have been no fundamental change
Electronic Filing - Received, Clerk's Office, May 1, 2008
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Tr. at 32. Therefore,
Abbott consi
actors and patient
demand. Tr. at 32-33. Different products emit
considered at the time of the original rulemaking. Tr.
at 32.
Statement
of
Reasons
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
facturing business
activity
iable year after
year. Tr.
at 32. The types of products Abbott produces in a given year
can vary based on
a number of mark
different levels
of
control technologies
that were
nix is a primary factor regarding
the variability of
Abbott's emissions. Tr. at 33. Additionally, new products that have
been introduced to
lity typically
have used water-based solvents, and there is no VOM produced
when water is used as a massing fluid. Tr. at 33. Abbott also
does not expect emissions
Statement of Reasons Question 2(b) asked whether Abbott has stopped
opera
2005. Tr.
at 35. However, it
should
fully validated, maintained and av
eds demand. Tr. at 35.
moray Question
I 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 AB 16 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,
t. Tr. at 3
stated that tunnel dryer #4 has not
been
in
use since
10
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* * * * * PC 2 * * * * *
Abbott has converted to all beverage
grade ethanol w
the denaturant. Tr. at 38.
Beno Prefiled Testimony
Quest
choosi
does not contain
asked for explanation of the basis for
the type of solvent used as massing fluid by Abbott. In response,
Ms. Beno
stated that the choice of massing 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
o do with the choice of solvent. Tr. at 38-39.
Water or ethanol can be used in
Beno Prefiled Testimony Question 3(a) asked for comment on
w
dryers.
ates increased use of water in product lines using
both tunnel dryers and fluid bed
Ms. Beno state
of
water in new
products.
to be an increased use
Tr.
at 39.
However, it is not practical
to change the ethanol-
based processes to water-based processes because of
Food and Drug
fluid as it develops new products, with a preference to use water. Tr. at 39.
Beno Pref led Testimony Question 3(b) asked whether the anticipated increase in
use of water
for massing fluid is intended to reduce
VOM
emissions. In response, Ms.
voidance is one of several factors considered by Abbott
ng from increased use of water for the massing fluid. Tr. at 39-40.
nefits include increased raw material costs, reduced worker exposure to organic
ty due to reduction of flammable solvents.
Tr. at 40.
I1
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Beno Prefiled Testimony
Question 3(c: ked why Abbott
considers water-based
e." In response, Ms. Beno
stated that water-based products
are
preferable for a number of reasons.
Tr. at 40. They are preferable because
they do not
contribute
to VQM emissions, reduced raw material
costs, reduced worker exposure,
and
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
my
due to their operation. Tr. at 40. In a fluid
bed dryer, individual
are airborne in the warm air
stream and the air moves freely on all
surfaces of the granule
drying process
and
higher
qua]
rying process. Tr. at 40. This results in a much more
even
-product because of the evenness
of the drying. Tr.
at 41. Tunnel dryers, on the other
aterial 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.
dryer is similar
to that found in baking: some parts of the product
are
more
done that other parts. Tr. at 41. Whereas in the fluid bed drying
technology, more
of the product or granules are
exposed to the warm air across the entire surface, making
for
a much more uniform drying process.'`
Beno Prefled 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
concentrate
on purchasi
12
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* * * * * PC 2 * * * * *
g 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
on-scale standpoint." In response, Ms. Beno pointed
out that one example of the
inefficiencies
created by the current rule is that the most
appropriately size
scale
merit may not be chosen. Tr, at 41.. In the event that the small-
eess train would be approaching its lim
ott may be forced to use the large-
scale process
to process smaller batches than would
normally
be processed in that
process train. Tr. at 42. In such a situation, the full capacity of the equipment would not
be ut
Beno Prefiled Testimony Question 5(
Tr. at 42.
ions, that are considered i
use for a
other than a dryer's
Beno stated that technology
is
conside
As noted above, a product can be
produced either by a tunnel dryer or a
flui
er, 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 ma
cleaning. Tr. at
43.
ante
or
Wells Prefiled Testimony
Questions
1 asked
about
whether the
definition
of
1 actual emissions" used in Mr. Wells' prefiled testimony is based on USEPA's
ay
Question 2(a) asked why the baseline
was
not
calculated based on the average emissions of the past two years. Wells Prefiled
13
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* * * * * PC 2 * * * * *
Testimony Question 2(b) asked why emissions
from 1999 and 2000 were considered
esentative.
change in
the
e to these questions, Mr. Wells stated that
there has been a
ilosophy on the conceptual level in USEPA's
application of historical
of "historical actual emissions" that appears
in
2001 guidelines
developed by USEPA is the same as the concept
Sign
nett
he Prevention of
cant Deterioration ("PSD")
or non-attainment New Source Review ("NSR")
previously used and was in place at that
time. Tr. at 44-45. That
definition of "historical actual emissions"
referred to the two years
ly
or another two-year period, if it could be determined more
representative.
y, there were a number
of
problems
with
determining whether a particular period
was representative, so USEPA changed the
ition
of actual emissions in 2002. Tr. at 45. At th,)
i
1 111
called "baseline actual emissions" for the PSD and NSR
any 24-month period
am t
ed the use of
i
a ssures that a facility can look back far
enough to
find
a representative business cycle so
ate
periods when normal fluctuation of business would result in relatively
higher emissions. Tr. at 45. Illinois EPA and USEPA recorn.mended this new
o 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
VOM
emissions from 1999
and 2000 are at least twice as much as the
ons from the next five years, Abbott chose 1999 and 2000 as representative
u
have to use
the same drying system or massing fluid, it would want to be able to fulfill
14
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* * * * * PC 2 * * * * *
the demand. Tr. at 47. Additionally, Abbott reduced the historical baseline
from 1999
and 2000 by ten percent. Tr. at 47. Overall, if Abbott ran all its dryers at capacity, it
would produce 45 tonlyr, and the proposed regulatory relief would 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 VOM limits apply to dryers located at the Abbott
Laboratories,
Building AP I
oposed
amendments to Section 218.480(b)(4) refer
tunnel
dryers. In response,
Wells
stated that Abbott's concern with the s
2 18.480(b
p roblem if t
Section 218
218.480(b) still applies to the
Facility. Tr. at 50. It is possible
ed dryer in another building for a totally
unrelated manufacturing process, and thus, pr
ion of the equipment was that
now covers the entire
Facility. Tr. at 50. Abbott would not have a
ecification were not made on the SSEO. Tr. at 50. With
regard to
erstandin
. Tr. at 50-51.
ott 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.
the following testimony
to address the questions of the
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 1(a) asked whether the US EPA
e should first adopt some type of
discretionary EIP policy
before considering
a request such as the one Abbott has made. In response,
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* * * * * PC 2 * * * * *
Mahajan
of
Illinois
EPA's Air Quality Planning Section of the Bureau
of Air state
EPA does not in
t
Steve Rosenthal of USEPA
and was told that state adoption of an EIP
ended, but not required. Tr. at 49.
. Tr. at 49.
adopt such a policy,
but
ssue on
USEPA EIP Guidance Questions 2 asked
whether
Illinois
EPA believes that the
proposed rule and its supporting
documentation satisfies EIP principles. In response, Mr.
Illinois EPA discussed the issue with USEPA and con
amendment is consistent with the EIP guidelines.
Tr. at 49.
idance
Question 3(a) asked whether the SSEC elements are those
described under Section 4.1 (b) of the gu
. Tr.
at 49.
ned VOM
Bern that t
e 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
and it was confirmed that the proposed combined VOM limit was consistent
EIP gu
Finally,
. Tr. at 49.
indicated its
support
for the rulemaking.
Tr, at 54.
page 38. In response,
Mr.
tion
ring,
counsel
for Abbott
addressed
the issues
regarding economic and
budgetary effects raised by the Board in the January 31, 20108 Hearing Officer Order.
T he proposed rule will, if adopted by the Board, apply only to specs
16
ahajan also noted
that Illinois
on units
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within Abbott's facility. The proposed rule will allow for increased operational
flexib at Abbott's facility, which, i
result in more efficient and cost-
effective production of pharmaceutical products. Moreover, the proposal will not impose
any new requirements upon
here will be no budgetary effect. In light of
eeific nature of the proceeding, and the information set forth in
oral 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 of the
economic and budgetary effects of Abbott's
posal. Tr. at 9-10.
IV.
ADDITIONAL INFORMATION PROVIDED TO TH
g, counsel for
requested that Abbott submit to USEPA supporting emissions calculations
for
years,
1999 and 2000. Tr. at 52. Since that time, Abbott has provided the
requested in
both Illinois
EPA and
USEPA.
V. SITE-SPECIFIC
AMEN ENT TO SECTION 218.480f-b)IS_PRO
The testimony at the
Hearing demonstrated that Abbott has worked closely with
Illinois EPA and USEPA over the course of the
last several years, and Illinois
stated that it supports the
rulemaking. Tr. at 54. The amendment groups the VC7
has
the dryers for the purpose of meeting
the emission requirements for the
Subpart
T and allows Abbott greater flexibility in
its
acturing process.
by 24.3 tonlyr, the total amoun
ted by the affected dryers pursuant to the Subpart T
'
Abbott provided annual summaries
of the 1999 and. 2000 dryer VOM emissions in an April 23, 2008 e-
mail to Mr. Matoesian and Mr. Mahajan of Illinois EPA and
Mr. R.osenthal of USEPA. And, in discussions
with counsel for
Illinois EPA, Abbott has confirmed that there is no requirement
(for SIP submi
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 util
e most
efficient process unit for each batch process, irrespective of recent past usage of specific
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)
of this Section,
the air suspension
coater/dryer, fluid bed. dryers, tunnel dryers, and Aecelacotas
located in Libertyville Township, Lake County, Illinois shall be
exempt from the rules of
this
Subpart,
except for Sections 218.483
through 218.485, if emissions of VOM not vented to air pollution
control equipment do not exceed the following levels:
ion coater/dryer: 2,268 kg/year (2.5
2)
tons/year)
tons/year);
3)
Except as set
forth in
Subsection
218.4ý0(b)(4ýbelow, far
each
tunnel dryer: 6,803 kg/year (7.5 tons/year),
set
forth in
Subsection
218.480(b)(4) below, for
and
ection 218.480(b)(4) shall not
.6 tons/year)
BOARD NOTE:
ers are otherwise
referred to as warm air dry],
-45) For each Accelacota: 6,803
kg/year (7.5 tons/year).
VII. CONCLUSION
ed upon all the evidence
that has been presented to the Illino
Pollution Control Board, the requirements of Sections 27 and
28
of
the Act (415 ILLS
5/27 and 28), 35 Ill. Admin. Code
§
1022 10
and 35
02(b) have
this proceeding. ABBOTT LABORATORIES,
therefore, respectfull
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requests that the Illinois Pollution Control Board adopt the proposed amendments to 35
Ill. Admin. Code § 218.480(b).
ABBO'T'T 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 of its Attorneys
Dated: May 1, 2008
e D. Hodge
Lauren C. Lurkins
ODGE DWYER ZEMAN
3150
Roland Avenue
Post Office Box 5776
Springfield, Illinois 62705-5776
(217) 523-4900
s /F'ost-
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