ILLINOIS POLLUTION CONTROL BOARD
April
7,
1988
IN THE
MATTER
OF:
AMENDMENTS T0
35
ILL.
ADM.
CODE
)
R86—10
211
& 215 ORGANIC MATERIAL EMISSION
STANDARDS AND LIMITATIONS FOR
SYNTHESIZED PHARMACEUTICAL
MANUFACTURING PLANTS.
ADOPTED RULE.
FINAL ORDER.
OPINION AND ORDER OF THE BOARD
(by J.D.
Durnelle):
This matter comes before
the Board upon
a February
26,
1986,
proposal
for the adoption of amendments
to 35
Ill.
Adm.
Code 211
and 215 filed
by the Illinois Environmental Protection Agency
(Agency).
The proposal was accepted
and authorized
for hearing
by Order
of February 26, 1986.
On April
23,
1987,
the Agency
submitted an amended proposal.
Hearing was held on June
9,
1967,
in Waukegari.
The Agency filed
a second amended proposal on July
27,
1987,
and
a third amended proposal on August
24,
1987.
The
second hearing was held on August
25,
1987
in Chicago.
On
September
21, 1987,
the Agency filed
the
fourth amended proposal,
which was presented at
the third
hearing, held September
22,
1987.
On October
28,
1987,
the Agency filed
the fifth amended
proposal, which was presented
at
the fourth hearing
held October
30, 1987.
On August
6,
1987,
the Board
adopted
an Order sending
the
Agency1s second amended proposal
to first notice publication
in
the Illinois Register.
As
a result of impending deadlines
imposed by the Clean Air Act (42 U.S.C.
7401), the Board
took
no
position on
the merits of
the Agency proposal
at that time, but
rather directed
the proposal
to first notice publication
in an
attempt
to expedite the process of promulgating
final
regulations
and
to comply with
the federal deadlines.
First notice was
published
at
11
Ill.
Reg.
14592
(Part
211)
and 14617
(Part
215)
on September
4,
1987.
On September 24,
1987,
the Secretary of
State’s Administrative Code Division filed comments on the
proposal.
Those changes have been adopted
at Second Notice.
Other comments have been
filed
by the Agency,
Abbott Laboratories
(Abbott),
the North
Shore Sanitary District (~SSD), and the
United States Environmental Protection Agency
(USEPA).
1
The Board notes that USEPA’s comments were filed
on December
14,
1987,
after
the scheduled comment period had expired.
The
comments were admitted
into
the record pursuant
to Hearing
(continued)
88—117
—2—
On November
13,
1987,
the Department of
Energy and Natural
Resources
(DENR)
filed
a negative declaration
stating its
determination that the preparation of
a
formal economic impact
study
is not necessary
in this proceeding.
The negative
declaration was based
on DENR’s
finding that “the cost of making
a formal
study is economically unreasonable
in relation
to the
value of
the study to the Board
in determining
the adverse
economic
impact of the regulation.”
Also filed on November
13,
1987 was notification of the concurrence of the Economic and
Technical Advisory Committee
(ETAC)
in DENR’s negative
declaration.
On February
4,
1988
the Board adopted
a Second Notice Order
sending
the proposed amendments
to the Joint Committee for
Administrative
Rules
(JCAR)
for review.
JCAR’s second notice
period began on February 16,
1988 and ended April
1,
1988.
On
February
29,
1988
the Board recei~ci a cequest
from JCAR to waive
the forty—five
(45) day limitation because JOAR was unable
to
schedule
a meeting
in March.
JCAR requested
that the Board waive
the second notice review period until JCAR’s April
12,
1988
meeting.
By letter
to JCA~dated
March
4,
1988
the Board
respectfully declined
to waive
the second notice review deadline
of April
1,
1988.
The Board
stated that the Attorney General’s
Office, which
is representing the interests of the
State of
Illinois
in the State
of WiSConsin
v.
Lee
M.
Thomas,
Administrator,
United States Environmental Protection Agency
(Civil No.
87—C—0395,
United States District Court
for the
Eastern District
of Wisconsin),
had strongly advised
the
Board
to
enact and adopt
this
rule as soon as possible.
The Board
noted
that
a consent decree
is
in the process
of being negotiated
and
entered
and that any deviation
from the dates
set forth therein
could
be taken
as evidence of bad faith on the part of Illinois
by Wisconsin.
Therefore,
the Board
today adopts
these rules without JCAR
having taken formal action during its second notice review
period.
The Board properly takes this action pursuant
to Section
5.01
of the Administrative Procedure Act
(APA).
Also consistent
with Section
5.01
of
the APA,
the Board today incorporates the
agreements made during the second notice period
in response
to
suggestions of
the JCAR staff.
The Board notes that these
changes
are non—substantive clarifications only.
These second
notice changes are addressed below.
Backg round
The overriding
basis of
the Agency’s proposal
is to correct
deficiencies
in the Illinois State Implementation Plan
(SIP)
Officer
Order
granting
the Agency’s Motion for Leave
to File
Instanter also filed December
14,
1987.
88—i
IS
—3—
which have been
identified
by
the United States Environmental
Protection Agency
(USEPA).
Section
172 of
the Clean
Air Act
requires the state
to impose the use
of reasonably available
control
technology
(RACT)
on existing sources
in non—attainment
areas.
On Nay 19,
1978,
USEPA gave notice that the
SIP must
include,
at least
for major
urban areas, enforceable regulations
reflecting
the
application
of
PACT
to
those
stationary
sources
for
which
JSEPA
has
published
control
techniques
guidelines
(CTGs)
since 1978.
In December,
1978,
a CTG was published
entitled “Control of Volatile Organic Emissions
from Manufacture
of Synthesized Pharmaceutical Products.”
On April
3,
1980,
the Agency proposed
in R80—5 regulations
for
the
control
of
volatile
organic
materials
from
the
manufacture of synthesized pharmaceuticals,
together with other
regulations generally known
as the PACT
II
categories.
On
December
30,
1982,
the Board adopted
the proposed rules, but
without provisions
for
the control
of emissions from
the
manufacture of synthetic pharmaceuticals.
On July 11,
1985,
USEPA proposed,
in part,
to disapprove
Illinois’
Part
D
stationary source control strategy for failure
to meet
the RACT
II control
requirements, stating
its belief that
Illinois:
“failed
to
adequately
justify
exempting
this
source
category
from
the
requirement
of
PACT.
Further,
the
State’s
failure
to
adopt
regulations
covering
the
synthetic
pharmaceutical
manufacturing
industry,
leaves
these
sources
totally
unregulated.
USEPA
believes
that
cost
can
be
considered
in
determining
whether
or
not
a
regulation
should
be
adopted.
The
State
must,
however,
better
support
its
decision
not
to
adopt
these
regulations
due
to
the
unreasonably
high
costs.
For
example,
Illinois
could
compare
the
control
costs
for
this
industry
in
other
States
to
costs
for
this
industry
in
Illinois.
USEPA’s
analyses
indicate
that
PACT
exists
for
the
synthetic
pharmaceutical
manufacturing
industry.”
(50
Fed.
Reg.
28224—
28226,
July
11,
1985)
To
remedy
the
deficiencies
noted
in USEPA’s proposed
disapproval,
the Agency filed
its proposal,
initiating
this
proceeding,
on February 26,
1986.
the Board notes that this
rulemaking proceeding has been highly contested since the outset,
due
in part
to
the fact
that the proposed rules apply to only one
business entity
——
Abbott Laboratories.2
Abbott has opposed
the
Agency’s proposal throughout,
and has submitted
a proposal of its
own,
which
is
addressed
below.
As
a
result,
gathering
88—119
—4—
information sufficient
to enable
the Board
to make
a reasoned
decision consistent
with USEPA’s proposed disapproval
has proven
a difficull task.
However, after
four hearings and five
amendments refining the proposal
to
the complexities
of Abbott’s
operations, the Board believes that there
is sufficient evidence
to support
the Agency’s position that
its most recent proposal
constitutes PACT for Abbott.
As previously stated,
the Board ordered
the Agency’s second
amended proposal
to
first notice.
The
final version of the
Agency’s proposal
is comprised
of the fifth amended
proposal with
minor amendments suggested by the Agency
in
its final comments of
December
7,
1987.
The Board notes that this final proposal could
be sent to second first notice
for publication.
However,
the
Board does not believe
that the
public
interest
would
be
best
served
in this manner.
First,
the first notice published
in
August,
1987, gave ample notice of
the proposal
of
regulations
for pharmaceutical manufacturers.
The subsequent Agency
proposals constituted mere refinements
to
the proposal
so as to
better conform
to Abbott’s actual operations.
Second,
as will be
discussed
below, Abbott
is the only source affected by the
proposed
rules, and
it has actively participated
throughout
the
proceeding.
Thus, Abbott has had actual notice of each change in
the proposal.
Applicability
At hearing,
the Agency presented data
that i9cluded the list
of pharmaceutical manufacturers
(Ex.
10, Table
3)
that would
be
potentially affected by the Agency’s proposal.
Proposed Section
215.480 would
render the regulations applicable
to sources
emitting more
than 6.8 kilograms per day (kg/day)
(15 lbs/day)
of
volatile organic material and more than 2268 kg/year
(2.5
tons/year),
or,
if less than 2.5 tons/year,
to any single source
exceeding 45.4 kg/day
(100 lbs/day).
Applying the
15 lbs/day,
2
Abbott’s
manufacturing
operations
include
two
plants
located
approximately
five
miles
apart
in
Lake
County,
Illinois.
The
North
Chicago
facility
is
a
large
complex
devoted
to
fermentation
facilities,
synthetic
pharmaceutical
production,
laboratory
and
pilot
plant
research
and
development,
and
administrative
offices.
The
Abbott
Park
facility,
located
in
an
unincorporated
area of Lake County,
houses administrative offices,
laboratory
research and development,
diagnostic kit assembly and
pharmaceutical
product
preparation
from
bulk
products
~anufactured
at
North
Chicago
or
elsewhere.
Citations
to
the
record
in
this
action
are
made
as
follows:
1)
references
to the Board hearing transcripts are
to
“R.
________“;
2)
references
to
exhibits received by the Board
are
to Ex.
________“;
3)
references
to public comments are
to
“P.C.
88—120
—5—
2.5 ton/year standard
to
the list
of manufacturers potentially
affected, the Agency concluded
that only Abbott’s facilities
would
be affected by the proposed
rule
(R.
86).
Although the
fifth amended proposal amends
the applicability criteria
in
certain respects,
the Agency has not indicated that other
facilities are thereby brought within the purview of the
regulation.
The Board believes that
the regulations remain
applicable only
to Abbott.
Fifth Amended Proposal
From
the outset,
the Agency and Abbott have held and
expressed
widely divergent estimates of
not only the actual,
installed
costs
of
control
equipment
but
also,
and
more
fundamentally,
the
maximum
reasonable
cost
per
ton
of
volatile
organic
material
controlled.
The
CTG
notes
the
complexities
associated
with
the
regulation
of
pharmaceutical
manufacture:
“Each
plant
is
unique,
differing
from
other
plants
in
size,
types
of
products
manufactured,
amounts
and
types
of
VOC
used,
and
air
pollution
control
problems
encountered.
The
dissimilarities
make
it
impossible
to
define
typical
emission
levels
or
emission
factors
for
an
average
plant.
This
in
turn
prevents
identifying
in
this
document
which
sources
definitely
need
to
be
controlled
and
how
much
overall
emission
reduction can
be effected.”
(Ex.
6,
p.
2—2).
Furthermore,
“Because
the
amount
and
type
of
emissions
vary
widely
from
plant
to
plant,
each
control
application
will
be
unique.
Therefore,
in
some
situations
control
system
construction
materials,
operating
conditions,
installation
expenses,
etc.
will
be
different
form
those
assumed
in
calculating
costs
for
this
chapter.
In
instances
where
regulatory
decisions
hinge
on
the
cost
of
control,
it
would
be
proper
to
consider
additional
information
that
may
more
accurately
reflect
control
costs
for
the
plant
in
question.”
(Ex.
6,
p.
5—1).
The Agency secured the assistance of
Mr.
Thomas Ponder4
lfl
the
development
of
the
proposed
regulations.
Mr.
Ponder
prepared
a
report
(Ex.
24)
that
was
aimed
at
determining PACT
for the
88—12 1
—6—
Abbott facilities and testified
(Ex.
23)
that of the over
100
sources of volatile organic material
(VON)
emissions
at Abbott’s
facilities, only 12 sources
(two
in
the fermentation
facility at
North Chicago and
ten at the packaging facility at Abbott Park)
were cost—effective
to control.
His report evaluated
incinerators
(both thermal
and catalytic), condensation,
refrigerated condensors,
scrubbers and carbon absorbers and
concluded
that
the
12
sources,
emitting
either
acetone
or
ethanol, would have
the most cost—effective controls
if they
employed
scrubbers.
The
control
cost
of
other
sources
in
Abbott’s
facilities
(Buildings
200
and 800) which emitted
less than
2.5 T/yr were
also evaluated
in the PEI
report.
However, Mr.
Ponder
recommended that such sources were infeasible
to control since
the cost effectiveness exceeds $5,000 per ton of
VOt’l
controlled.
This approach
is consistent with the control
technique
guideline
(CTG)
document
(Ex.
6) which states that the
“decision
to
require
control
of
specific
exhaust
streams
will
be
determined
based
on
local
air
quality,
the mass
emission
rate
of
volatile
organics,
and
the
cost
to
the
operator
to control
the streams.”
The
CTG
does
state
that
cost—effectiveness
was
not
measured
for
this
industry
because
annual
emissions
cannot
be
estimated
in
a
manner “consistent with the costing techniques.”
This
is due
to
the
large
variations
in
emissions
from
pharmaceutical
manufacturing
plants.
At the September
22,
1987 hearing, Abbott presented
testimony that the cost—effectiveness of control was much greater
than
$5,000
per
ton
of
VOM
controlled.
Abbott
hired
ETA,
Inc.
(ETA)
to
evaluate
the
implications
of
the
Agency’s
proposed
regulations.
The ETA report
(Ex.
39)
lists
the total
annual
emissions from Abbott’s two plants at 131.4 T/yr with only 71.02
T/yr
being
affected
by
the
proposed
rule.
This
report
identified
19 sources,
7 more than the PET report.
This comparison,
presented
in
Table
2.3,
Ex.
39,
shows that different emissions
were
used
for
the
individual
sources.
A
more
significant
difference
between
the
reports
is
that
the
ETA
report
only
evaluated
carbon
adsorption
and
incineration
for
all
sources
at
Abbott
Park.
For
the
emissions
at
the
North
Chicago
Plant,
incinerators
and
refrigerated
condensors
were considered,
except
for one source
(PC 815)
for
which
a
scrubber
was
evaluated.
The
4
Mr.
Ponder,
employed
by USEPA as
a consultant,
is Vice
President
and Western Regional Manager
of PEI Associates,
Inc.
(PEI).
He
is
a
certified
cost
engineer
and
has
experience
in
volatile organic material control
and cost effectiveness.
88—122
—7—
PEI report rules
out incineration, carbon adsorption, and
refrigerated condensors as being
too expensive compared
to
scrubbers and identified packed bed scrubbers as the control
method
to be used at Abbott’s
facilities.
Abbott has said
that
scrubbers cannot be used
at Abbott Park because process water
is
not readily available and because of limitations of
the municipal
wastewater
•treatment system
(R.
547—548; 454—455;
486—489).
The
ETA report presented the cost—effectiveness
for control
of the 19
sources,
identified
by
them,
which
ranges
from
$3,723/ton
(for
a
scrubber on the
PC 815 source)
to $37,177/ton
(for
a refrigerated
condensor
on
the
PC
802
source).
The
rest
of
the
sources,
except
the two
tray dryers,
are fitted with
incinerators.
The discrepancies in
the
two reports are
(1)
generally
higher emissions
from the sources as given
to
PEI by Abbott than
the emissions
used
by Abbott
(i.e.,
ETA),
(2)
use of different
types of controls and failure of ETA
to evaluate scrubbers,
and
(3)
failure of PEI
to take
into account
the correct costs of
water
and wastewater
treatment.
The emissions discrepancy was explained
at
the September
22,
1987
hearing
(R.
582—608).
PEI was given the 1986 production
forecast while ETA was provided
the 1987 production
forecast.
Because of
the wide variations
in VOM emissions
from day
to day,
cost—effectiveness numbers
can change dramatically.
Abbott has
not provided
the Board with the necessary historical data or
the
range
of
emissions
that
might
be
expected.
Abbott
has
not
provided
cost
data
on
installation
of
scrubbers,
which
makes
it
very
difficult
to
compare
with
the
costs
of
control
submitted
by
PEI.
Abbott
has
summarily
ruled
out
scrubbers
except
for
one
source
(PC
815).
Mr.
Robertson,
of
Abbott
Laboratories,
provided
operating
and
maintenance
unit
costs
at
Abbott
(R.
488—489)
from
which
the
water
and
wastewater
treatment
costs
are
given
below:
Cost
for
Cost
For
Item
North
Chicago
Abbott
Park
Lake
Water
$0.142/l000
gal
City
Water
$1.00
/1000
gal
$1.05/bOO
gal
Well
Water
$0.40/bOO
gal
Wastewater
Treatment
a)
Abbott
plant
1.
Flow
$0.30/bOO
gal
2.
SOD
$0.35O/lb
88—123
—8—
b) Gurnee
POTW
1.
Flow
$0.30/bOO
gal
2.
BOD
$O.3l/
lb
3.
TSS
$O.28/
lb
c)
Clavey Road POTW
1.
Flow
$0.30/bOO
gal
2.
BOD
$0.3l/
lb
3.
TSS
$0.29/
lb
Based
on interviews on August
26, 1987
and October
12, 1987
conducted
by Mr.
Ponder,
of PEI,
with Ms. Penny Bouchard,
of the
North Shore Sanitary District
(NSSD),
Mr.
Ponder stated that
the
wastewater treatment rates
are $0.34 per thousand gallons of
flow;
$0.34/lb of SOD; and $0.31/lb of suspended
solids, which
would
be
applicable
to
Abbott
discharged
wastewater
released
to
either
the
Gurnee
or Waukegan plants which are closest
to Abbott
Laboratories
(see
Attachment
3,
Ex.
59).
At
the
final
hearing
on
October
30,
1987,
Mr.
Ponder
used
the
new
emissions
data
that
Abbott provided during
the September
22,
1987
hearing
and
the
NSSD wastewater
treatment costs
to come
up with up—dated costs of
control
at Abbott’s facilities
(Ex.
59).
The testimony of Mr.
Ponder addressed
the cost of acquiring
well water
where city
water
is not available.
The recalculated
cost estimates
for
emission control
on 13
sources at the two Abbott facilities
is
found
in Exhibit 59, Attachment
I,
Table
1.
The change
in the number
of sources
to be controlled
is the
result of the latest
(1987 projection)
emissions estimates
provided by Abbott and the estimates of water
and wastewater
treatment costs.
The control method with the lowest cost per
ton
of VOM controlled
is also shown on
the
table
in the above
referenced Exhibit
59.
Using
a criterion
of $5,000 per ton,
the
only sources
Mr.
Ponder
recommended
for control
at Abbott’s
facilities
which
are
cost—effective
(C.E.)
are:
a)
one
(1)
source,
PC
842
at
N.
Chicago
—
C.E.
$2,060/ton
with
incinerator
b)
two
(2)
tray driers
at
N.
Chicago
—
Unit C.E.
$2,226/ton
with wet scrubber
c)
eight
(8)
tunnel driers at Abbott Park
—
C.E.
$4,450
with wet scrubber
d)
two
(2) accelacotas at Abbott Park
—
C.E.
$4,250/ton
with
wet
scrubber.
With regard
to
the water
supply inadequacy problems cited
by
Abbott,
Mr. Ponder states
in
Ex.
59 the following:
88—124
—9—
“Information
supplied
by
Abbott
indicates
that
current
water
supply
from
the
Niagara
formation
(sic)
is
inadequate,
and
there
is
currently
not
enough
city
water
to
supply
these
scrubbers
to
control
the
tunnel
driers
and accelacotas
at
Abbott
Park.
However
the
Well
Company
report
clearly
states
that
we
could
get
more
water
by
digging
a
deeper
well.
We
evaluated
the cost
of
that well
and
believe
we
could
supply
wa~er
for
the
scrubbers at
90 cents per gallon
based
on new
wells going
over
1,000
feet
deep.
New water
supplies,
therefore,
are
not
a
problem
at
Abbott.”
Abbott believes that PET’s estimated well
cost of $130,000,
resulting
in $0.90 per 1000 gallons
is unrealistically low and
attempts
to establish
in Fig.
2.2,
P.C.
3 that
the well cost
is
$2.38/bOO
gallons.
The Board
believes that Abbott’s calculation
of this
figure
is erroneous since
it divides
the
total annual
cost of
four operating wells by the volume of water
(in 1000
gallons)
derived
from
only
one
well.
Penny
Bouchard,
NSSD,
submitted
comments regarding
the
actual costs of discharging
to NSSD’s plants
(P.C.
5).
Ms.
Bouchard
states that various ordinances of the NSSD require
that
total costs
are related
to
the specific
user
and must
include
(1)
Permit fees,
(2) Monitoring Costs,
(3) User Charge fees and
(4)
Capital costs.
PEI’s estimate only included
the User Charge
fees,
and even this
figure may have been underestimated,
according
to Ms. Bouchard, since billing
is based
on the COD:BOD
ratio
of
the
wastewater.
Abbott’s
wastewater
has
typically
had
a
high
COD:BOD
ratio
and
has
been
charged
more
that
$0.34/lb
SOD,
the
number
that
is
used
by
PEI
in
its
calculations.
This
information
regarding
the
considerable
costs
of
wastewater
discharges
from
an
industrial
source,
such as Abbott,
to
NSSD
plants
was
also
transmitted
to
J.E.
Spessard,
PET,
Inc.
who
in
a
November
20,
1987
memorandum,
a
copy
of
which
was
sent
to
Mr.
Ponder,
stated
the following:
“I
have
recalculated
emission
control
costs
for Abbott’s
two Accelacotas
and
eight
tunnel
driers
•...
Revised
annual
control
costs are
$40,750
for the Accelacotas
($6,400 per
ton of
VOC
controlled)
and
$27,250
for
the
tunnel
driers
($7,600
per
ton
ton
of
VOC
controlled)
.“
The Board
believes that
Mr. Ponder meant “90 cents
per 1000
gallons.”
88—125
—10—
Spessard’s memorandum was attached
to
a cover letter
from
Mr.
Ponder,
PEI,
to the Agency which states that
the cost
of
controlling the emissions
of VOM from the Accelacotas
and
the
tunnel driers would exceed $5,000/ton.
(Attachment
4,
P.C.
4).
Based
on this new information, the Agency submitted comments on
December
7, 1987
(P.C.
4)
which request
the Board
to amend the
Agency’s
fifth amended proposal which would require Abbott to
control
a total
of only three
(3)
sources, namely,
PC 842 and two
tray driers,
located
at the North Chicago plant.
The Board
accepts
the
Agency’s
amendments:
the Second Notice Order
includes the suggested
revisions.
Final Agency Proposal
As the final version of the proposed regulations control
only the three above—named
sources,
this Opinion
will
focus
its
evaluation of costs on only those
three sources.
The costs of
controlling these three sources will be evaluated by comparing
the cost
of control
as estimated
by PEI
for the Agency and
ETA
for Abbott.
The comparison
is
illustrated by the following
table:
VOM
(T/yr)
Cost
($)
Total
Calculated
Source
Emitted
Controlled
Capital
Annual
per
ton
by
Coimients
PC
842
2.09#
1.88
10,800*
3,864
2,060
PET
Incinerator
2.O9#
1.88
51,300*
15,871
8,442
ETA
Incinerator
Tray
Driers:
No.
1
3.38
3.04
7,000
6,903
2,297
PET
Scrubber
No.
2
3.38
3.04
7,000
6,903
2,297
PET
Scrubber
Nos.l&2 7.76
6.08
7,000
12,010
1,975
PET
One
scrubber
for both
driers
No.
1
3.38
3.04
25,600
12,143
3,992
ETA
Scrubber
No.
2
3.38
3.04
25,600
12,143
3,992
ETA
Scrubber
4Emissions
are
less
than
2.5 T/yr, but exceed 100 lb/day
*Costs are based on a flow rate of 700 acfm
PC 842
For reactor PC
842,
Mr.
Ponder recommended and
the Agency
proposed control using
a small
incinerator.
PEI estimated
an
88—126
—11-
installed capital cost of
$10,800.
Abbott estimated an installed
capital cost of $51,300.
The Agency contends
that ETA’s
estimated costs
for the incinerator
to
control emissions
from
PC
842 are
“outdated
and do not reflect
true market conditions.
“ETA’s estimates are based
on
ten—year old costs data for
large,
custom—designed
incinerators.
“Presently, many companies offer
smaller, factory—assembled
incinerators
at much bower prices.”
(P.C.
4).
The Agency bases its statement on
a review of ETA’s
cost estimating methodology for thermal
incineration by Spessard
of
PET (Attachment
2,
P.C.
4), which gives convincing
arguments
for accepting PET’s cost estimates as being more realistic based
on equipment
and availability.
ETA also presented
some vendor
quotes,
the lowest incinerator being $19,000
for
a flow of 100
acfm (received by the Board November
13, 1987).
Mr.
Ponder,
PET,
stated
in testimony that “We
had different vendor quotes than
they
ETA
have.
I
am
not sure exactly
why...
They didn’t use
the same vendors.”
(R.
902).
PHI also submitted
a revised
vendor survey (received by
the Board November
30,
1987).
In
PHI’s survey, vendors were asked
for the cost of an
incinerator
at
a
flow rate of 300
cfm.
The lowest cost was from
the National
Incinerator Company for $5,000.
Based
on
all
the information provided,
the Board
finds that
the costs
of installation used by ETA appear
rather high.
However,
the unit cost
of the incinerator
used
by PEI might be
low since
they extrapolated
from costs obtained
for
a 300 acfm
incinerator
to one operating
at
a 700 acfm flow rate.
Because
packaged, skid—mounted incineration units are available,
the
actual costs are unlikely to be
as high as projected by ETA.
The
cost per
ton
is also
a function of the actual amounts of VOM
controlled.
Since
these emissions are small
and only one
incinerator
is involved,
the Board
finds
that
the cost predicted
to be
incurred by Abbott
in installing
an
incinerator
to control
PC
842 will not be unreasonably high.
Tray Driers
Mr.
Ponder also
recommended control by wet scrubber on two
tray driers at the North
Chicago facility.
The Agency states
that although Mr. Ponder
believes that one scrubber
could
serve
both
tray driers
(at a cost of
$1,975 per
ton),
he evaluated
the
installation costs
of separate scrubbers
for
the two driers
(P.C.
4,
p.
6).
The total capital cost of
a
scrubber
for each tray
drier
is $7,000,
which results
in
a cost
of $2,297, per
ton of
VOM controlled, well
under $3,000 per
ton
(P.C.
4,
p.
6).
Abbott,
however, estimated
that
the total capital
cost of
a
scrubber
for each tray drier
is $25,600, which translates
into
a
cost of $3,992 per ton of VON controlled.
Based on
the
information
in the record,
the Board believes that Abbott’s
estimates are high
for
the fairly small
scrubber required.
The
Board believes that emissions
from the tray driers can be
controlled
at
a cost
of less than $3,000 per
ton which, without
88—12 7
—12—
implying
that $3,000
is necessarily the cut—off
for
PACT,
the
Board believes
is reasonable.
Abbott estimated
the total VOM emissions from
its
pharmaceutical operations,
in
the absence of control,
at
4,627.3
T/yr and claimed
that
it is controlling 97.2
with existing
controls
(Ex.
52).
These existing controls
at Abbott’s plants
are process—related or required because
of Occupational Safety
and Health Administration regulations
(R.
685).
Abbott
is able
to achieve
a higher
level of control because
it uses cooler
(Lake
Michigan)
condenser water which results
in lower
VON emissions.
The Board notes
that
the Agency’s final proposal adopted at
Second Notice
is
still based on the CTG for this category with
some modifications that take
into account Abbott’s operation.
Thus
the rule
as
adopted is expected
to result
in less than
8
T/yr of
VON
reductions.
However,
this reduction
is
in addition
to the 97.2
(i.e.
4497.7 T/yr) VOM reduction already achieved
with existing
(CTG recommended)
controls.
Thus all
of Abbott’s
controllable sources
are brought
under
this proposed
rule
for
controlling synthesized pharmaceutical manufacturing
plant VON
emissions.
This fulfills the state’s requirement,
under Section
172
of the Clean Air
Act,
to adopt enforceable PACT regulations.
Abbott
Laboratories
Proposal
At hearing
on October
30,
1987,
Abbott submitted
an
alternative
proposal
for
the pharmaceutical
industry.
Abbott
states that its proposal
“embodies Abbott’s existing level
of
control
and
would
require
certain
controls
on
CTG
and
nori—CTG
sources
based
on
a
cost
effectiveness
of
$3,000 per ton.”
Abbott
believes that its proposal
is approvable because
it
is “based on
a reasonable cost effectiveness value.”
The Agency objects to Abbott’s proposal.
The Agency
believes that Sections 215.480, 215.481,
215.482, and 215.486
contain emission level cut-offs that are not justifiable as RACT
and,
therefore, not approvable by USEPA.
Further, the Agency
states that
in Section 215.480 and 215.486
of Abbott’s proposal
laboratory
hoods
have
been
deleted
as
a
source
category,
and
in
Section
215.481
centrifuges
have
been
totally
exempted
by
exclusion.
The Agency’s position on such emissions
is
that,
“Although
no
lab
hoods
or
centrifuges
at
Abbott’s
facilities presently meet
the
2.5
ton
per
year
threshold,
the
Agency
believes
these
sources would
become
cost effective
to
control
should
emissions
increase
beyond
2.5
tpy
(R.
pp.
207—208).
Lab
hoods
and
centrifuges
are
thus best treated
as the Agency
is treating all
other
sources:
by
designating
an
exemption
emission
level
beyond
which
the
source becomes
cost
effective
to
control.”
(P.C.
4,
p.
8).
88—128
—13—
The Agency also objects to Section 215.487
of Abbott’s
proposal,
which
would
allow Abbott the option of using
the
calculation procedures of
the CTG as
a substitute
for being
required
to conduct
a stack
test pursuant
to 40 CFR
60, Appendix
A,
Methods
25,
25A or
253.
The Agency states:
in
regulating
this
category
of
emission
sources
the
Agency
will
not
likely
routinely
request
stack
tests
to
determine
compliance,
however,
if
changed
circumstances
or
new,
future information
indicate
a need
to test
for
compliance,
the Agency
reserves
the
right
to
request
a
test
from
the methods listed.
Some
compliance
questions
cannot
be
satisfied
simply
and
exclusively
on
the
basis
of
calculations.”
(P.C.
4, pp.
8—9).
In response
to
a request by the
Agency,
USEPA conducted
a
review of Abbott’s proposal and submitted
its comments to the
Board
on December
14,
1987.
USEPA’s overall position on Abbott’s
proposal
is that “if formally submitted
to USEPA,
it would
be
proposed
for disapproval
in
the Federal Register”
(P.C.
7,
p.
3).
On
the
stack
test requirement of Section 215.487, USEPA
states:
The
Section
is
not
approvable
because
it
precludes
the
State
of
Illinois’
ability
to
require
a
stack
test.
This
capability
is
necessary
because
it
may
not
always
be
possible
to
accurately
calculate
a
source’s
emission
rate.
Stack
test
results
must
clearly
supercede
(sic)
the
results
obtained
by calculations which
are not based
upon USEPA
approved
stack
test
methods.”
(P.C.
7,
p.
3).
In response
to Abbott’s proposed Section 215.480,
USEPA
states that averaging emissions from batch operations
over the
duration
of
the
batch
operation
could
present
a
serious
rule
enforceability
problem.
“For
existing
source,
averaging
any volatile
organic
compound
(VOC)
emissions
over
a
period
in
excess
of
24
hours
can
only
be
done
in
accordance
with
the
January
20,
1984,
memorandum
from
John
O’Connor,
former
Acting
Director of the Office of Air Quality Planning
and
Standards,
and
only
as
source
specific
State
Implementation
Plan
(SIP)
revisions.
This memorandum, entitled “Averaging Times
for
Compliance
with
VOC
Emission
Limits
—
SIP
Revision
Policy,”
prohibits
greater
than
24—
hour
averaging
(which could
occur
from
a batch
88—129
—14—
operation)
by VOC sources
in
the Chicago
area
because
of
its
lack
of
an
approved
ozone
SIP.”
(P.C.
7,
p.
1).
USEPA stated,
in addition,
that an adequate basis
for deleting
laboratory
hoods
from the list of applicable sources had not been
established.
USEPA also commented
on Abbott’s proposed exemption
bevels.
USEPA
stated
that
the
exemptions
levels,
“which
are
substantially in excess of
Abbott’s emission levels,
are not
approvable.”
(P.C.
7,
p.
2).
USEPA’s
guidance
for
synthesized
pharmaceutical
plants specifies
applicability
criteria
of
15
lb/day
for
all
sources
of
VOC.
The
Only
area
in
which
Abbott
has
demonstrated
that
its
synthesized
pharmaceutical operations differ
from those
in
the
Control
Technique
Guideline
(CTG)
is
in
its
use
of
Lake
Michigan
water.
However,
Illinois’
proposal
takes
into
consideration
this
additional
cooling
(which
results
in
reduced
emissions)
by
adding
an
annual
exemption level.
This
annual
exemption level
has
the
effect
of
eliminating
sources
which
can
on
occasion
exceed
15
bbs/day,
from
the
specified
control
requirements.”
(P.C.
7,
p.
2).
Finally,
USEPA
noted
that
Abbott’s
proposal
included
a
number of exemption levels which are higher
than current
emissions.
L1SEPA stated:
“tihese
exemption levels are apparently based
upon
the
highest
emission
levels
which
can
occur
before
the
dollars
per
ton
of
control
go
below
$3,000/ton
(according
to
Abbott).
Abbott
considers
$3,000/ton
as
the
highest
cost—effectiveness
value
which
is
consistent
with
PACT
...
There
is
no
basis
for
Abbott’s
use
of
$3,000/ton
as
a
yardstick
for
establishing
PACT.”
(P.C.
7,
p.
2).
On
January
8,
1988,
Abbott
filed
its
Response
to
USEPA
Comments
with
a
Motion
for Leave
to File Instanter, which was
granted
by
Hearing
Officer
Order
on
January
18,
1988.
Abbott
devoted several pages
of comment
to “the manner
in which USEPA
has
elected
to
participate
in
this
proceeding”
and
tendered
responses
to
USEPA’s
comments.
The Board
is not persuaded
by
this
Response
that
the record contains information
and evidence
sufficient
to
overcome
the indication, by USEPA itself,
that
the
88—130
—15-
proposal
of Abbott
is not approvable.
The Board’s charge
is
to
promulgate regulations
imposing RACT on sources
in non—attainment
areas.
The Board
is persuaded that
the Agency’s proposal
satisfies
that charge,
and the Board believes that the Agency’s
version
is approvabbe by USEPA.
Therefore,
the Board declines
to
implement the language proposed
by Abbott.
Section 215.102 Measurement of Vapor Pressures
The Agency proposed
to amend Section 215.102, Testing
Methods,
to add a subsection on
the measurement of vapor
pressures.
The Agency proposed
similar language
in R86—37,
a
proceeding
devoted
to
the
definition
of
Volatile
Organic
Material.
However,
in R86—37, which was adopted
for final notice
on December
22,
1987,
and published at
12
Ill
Reg.
815, January
8,
1988,
the Board adopted certain amendments
to
the Agency’s
proposed language.
First,
for
a single component,
the vapor
pressure
is to be determined
by ASTM (American Society of Testing
and
Materials)
Method D—2879—83,
or may be obtained
from
a
published source, such as the sources listed
in Section
2l5.b02(b)(l).
The revision was necessitated
in R86—37 by JCAR
(Joint
Committee on Administrative Rules)
comment
that,
in
its
view,
the language as
proposed by the Agency constituted an
improper
series
of
incorporations
by
reference.
Specifically,
JCAR believed that the textbooks listed were
improper
sources
for
incorporation
into
the
Administrative
Code,
as
the
Administrative
Procedures Act makes no provision
for
the incorporation of
textbooks.
As
a
result, the language was revised
to avoid
the
characterization of the textbooks as
incorporations by
reference.
The Board
notes
that
the language proposed
in R86—37
has
been
finalized.
Thus, much of the language proposed
at first
notice
in
this proceeding
is no longer
necessary:
it has already
been adopted.
However,
the Board
has made certain changes
to Section
215.102(b) (2), regarding determination of the vapor pressure
of
a
mixture.
At the final
hearing, Dr. Harish Rao, of the Board’s
Scientific
and Technical Staff,
noted that there was concern
expressed during
the course of the hearings that the Agency’s
proposed language was not clear.
Dr. Rao offered alternate
language,
aimed
at clarifying
the Agency’s intent, and requested
comment
from the participants.
Both
the Agency
(P.C.
1)
and
Abbott
(P.C.
2)
agreed that
Dr. Rao’s language
is an acceptable
substitute
for
the Agency’s language and
intent.
However, Abbott
objected
to
the application of Section 215.l02(b)(2), stating:
“the
true
vapor
pressure
of
a mixture
is equal
to
the
sum
of
the
actual
vapor
pressures
of
each
component of
the mixture
(whether or not
the
mixture
is
a
VON
as
defined
by
regulation)
weighted
by
its
mole
fraction
in
the
mixture...
any
other
method
of
calculation
88—131
—16—
which
does
not
take
into
account
every
component,
will
not
yield
the
correct
vapor
pressure of
a mixture.”
(P.C.
2, pp.
1—2).
Abbott also criticizes
the Agency’s proposed method as being
“inconsistent
with
the
methodologies
embodied
in
the
CTG
for
other
PACT
categories
upon
which
the
Board
has
based
its
other
corresponding
PACT
regulations.”
To
alleviate
the
concerns
expressed
public
comment,
the
Board
has
added
language
to
permit
the determination of the actual vapor pressure of
a mixture
pursuant
to ASTM Method D—2879—83,
since
the Agency’s proposed
language
may
not
yield
the
correct
vapor
pressure
of
the
mixture.
However
the
Board
assumes
that
the
Agency’s
proposed
measurement procedure will provide
a more conservative approach
to
the control
of VOM emissions
from pharmaceutical plant
operations.
Because
the Agency’s proposed language states that
the vapor pressure of
a mixture “may be
taken as either”
rather
than “is either”
in Section 215.102(b) (2),
the Board has opted
to
retain the Agency’s proposed method
to provide
an
alternative
to
the ASTM method.
Finally, the Board notes that
the language “organic material
or volatile organic material”
has been changed
to “volatile
organic
liquid”
and that “not”
has been deleted
in Section
2b5..b02(b)(2)(A).
Also,
in the Second Notice Order,
the Board
states that
in 215.102(b) (2),
language was added clarifying
the
sections applicability only to Subpart
T.
That statement was
incorrect.
No
language was added
to the text of
Section
2l5.l02(b)(2)(A)
limiting its applicability to Subpart
T.
Nor
is
that subsection intended
to be so limited.
Definition
of VON
In the first notice proposal, amendment was proposed
to the
definition of volatile organic material
(VOM).
As has been
previously noted, R86—37 was
a proceeding devoted entirely to
the
definition
of
VON.
The Agency has indicated
in other rulemaking
proceedings (i.e.,
R86—40)
that
it included
the proposed
amendment
to VON
in proceedings
other than R86—37 simply
to put
the regulated community on notice that the definition was
in the
process of change.
As
R86—37 has been adopted and
is
in effect,
the Board deems
it appropriate
to remove
the definition of VON
from further consideration
in this proceeding.
Compliance Date
In its final comments,
the Agency suggested amendment
to the
proposal
to provide
a compliance date of April
1,
1989.
The
Agency noted
that:
the
adoption
of
the
Agency
Proposal
would
require
Abbott
to
install
a
small
incinerator
88—13 2
—17-
and
two
wet
scrubbers
at
its
North
Chicago
Plant.
Mr.
Ponder and Dr.
Reed,
both of
whom
have
extensive
experience
in
VON
control
methods,
have
concluded
that
a
period
of one
year
from
the
effective
date
of
the proposed
rube
constitutes
an
ample
time
period
for
compliance
in
this case.
(P.C.
4,
p.
3).
Further,
the Agency stated that “USEPA’s interpretation of the
Clean Air Act and regulations
thereunder
do not mandate
a
December
31,
1987 compliance date.
To support this position,
the
Agency points to
a number
of
indications, including
(1) Proposed
JSEPA
Approval
of Kansas Ozone SIP,
(52 FR 36963—36967), which
includes compliance dates beyond December
31,
1987,
(2) Summary
of EPA’s Proposed Ozone
and Carbon Monoxide Attainment Policy
dated November
10,
1987,
which defines
“near
term attainment”
of
the ozone
standard as being
three
to five years
from the date of
SIP approval,
and
(3) SIP:
Approval
of Post—1987 Ozone
and
Carbon Monoxide Plan Revisions
for Areas Not Attaining
the NAAQS,
(52 FR 45044—45121), which states that the meaning
of
“near
term”
is within three
years and,
for
some areas,
five years
of EPA’s
approval
of the Area’s post—1987 plan revision.
(P.C.
4, pp.
3—
4).
Abbott does not disagree with
the concept of proposing
a
compliance date after
December
31,
1987.
However, Abbott
objected
to
the criteria used
to arrive at
the April
1,
1989
compliance date,
and proposed a December
31,
1989 as being
preferable “due
to
the uncertainties inherent in the permit
process.”
(P.C.
8,
p.
6).
Abbott’s objection
to the April
1,
1989 compliance date stems
from the Agency’s conclusion
that
“a
period of one year
from the effective date of this proposed rule
constitutes an ample time period
for compliance
in this case”
(See
P.C.
8,
p.
4).
Abbott notes that
the Agency’s conclusion
is
based on
statements by Mr. Ponder
of PET and Dr. Reed
of the
Agency.
Abbott argues that Mr.
Ponder
is:
“not qualified
to render
an opinion concerning
the length of
time
required by
TEPA
to permit
any
particular
source
or
item
of
control
equipment.
The
permit
process
cannot
be
conducted entirely concurrent with the design,
procurement,
construction
and
installation
of
new control equipment.
The permit issues must
be substantially resolved before Abbott or any
other
source
could
reasonably
be
expected
to
purchase
the
required
equipment
or
begin
construction and installation.
Even
the
final
design
of
the
equipment could
be
affected by
potential
permit
conditions,
of
which
Abbott
would
need
to be certain
before
the equipment
could
be
selected
and
purchased.
IEPA
often
88—133
—18—
requests
additional
information
during
the
permit
application
review
period,
and
it
is
often
necessary
to
waive
the
permit
decision
deadline
to
allow
LEPA
to complete
its review
process,
determine
the
particular
permit
conditions
and
issue
the
final permit.”
(P.C.
8,.. p.
5).
Abbott also argues that “the record does not show that Dr.
Reed has extensive experience
in VON control methods:
His
conclusion
that
Abbott
could
come
into
compliance
with the proposed regulation
in one
year
is
speculative
and
is
supported
only
by
telephone
calls
to
two
vendors.
Abbott
did
not
testify
that
it
would
purchase
any
required
control
equipment
from
these
vendors.
Abbott does not know
if the control
equipment manufactured
by these two vendors
is
suitable,
either
in
performance
or
materials
of
construction,
for
the
intended
applications.”
(P.C.
8,
p.
5).
The
Board,
perhaps
better
than
anyone,
realizes
the
injustice that would result from
a December
31,
1987 deadline
imposed
in this rube,
as that date has already passed.
The Board
notes
that
it has considered
this
issue
in other
PACT
proceedings.
However,
information justifying
a date later than
December 31,
1987
had not been submitted
into the records of
those proceedings,
and the Board
had been bound by the evidence
in the record.
Here,
the Board
is pursuaded
that the record
justifies
a date later
than December
31,
1987.
The only issue
remaining
is which date
to impose.
The Board
is not persuaded
by
Abbott’s evaluations of the credentials of
Mr. Ponder and Dr.
Reed.
Thus, the Board
is not persuaded that Abbott’s criticisms
of the April
1,
1989 deadline
are based on solid foundation.
Rather, the Board agrees that
a time period
of approximately one
year
from the date of adoption of the rules
will provide Abbott
ample time
in which
to comply with the regulations.
Therefore,
the Agency’s suggested compliance date of April
1,
1989
is
accepted and incorporated at Second Notice.
Incorporation by Reference
Certain materials have been incorporated by reference
into
Section
215.105, Incorporations by Reference.
First,
proposed
Section 215.487 states that certain
test procedures are
to be
consistent
with USEPA document EPA—450/2—78—04l.
The Board notes
that because
this material constitutes
a
standard
or guideline of
an agency of the United States,
the material must be
incorporated
pursuant
to Section 6.02(b)
of the Administrative Procedure Act,
which requires prior approval by JCAR.
The Board applied
for
and
88—134
—19—
on
December
21,
1987
received written
approval by JCAR to
incorporate the material by reference.
Second, ASTM
D
1946—67 and
ASTF1
D 2382—76
American
Society
for Testing
and Materials
test methods have been added
to the
list
of incorporations by reference.
In R86—39,
Synthetic
Organic Chemical
and Polymer
Manufacturing,
and R86—40,
Air
Oxidation Processes
in the Synthetic Organic Chemical
Manufacturing
Industry, the Board adopted regulations which
utilize
these
two ASTM procedures.
During
the second notice
phase of those
two rulemakings,
JCAR objected
to the inclusion of
the two ASTM references
in Section 215.105 because, according
to
JCAR,
a
section may not be proposed
for amendment at Second
Notice that was not proposed for amendment at first
notice.
There, Section
215.105 had
not been proposed
for amendment at
first notice.
However, because Section 215.105 had been proposed
for amendment
in this proceeding,
JCAR suggested
that
the
Board
incorporate
the ASTM methods
in this proceeding.
The Board
agreed and hereby complies with JCAR’s suggestion.
ASTM D 1946—
67 and ASTM D 2382—76 have been
added
at Second Notice.
Second Notice Revisions
As noted above,
the Board has incorporated certain non—
substantive revisions
to the
text of the proposed rules
for
purposes of clarification only.
Pursuant
to questions and
suggestions of the JCAR staff during Second Notice review,
the
Board agreed
to incorporate
these
revisions into
the final
text.
The changes
are as
follows:
Section 215.481:
“control”
was changed
to “equip.”
Section
215.483(b):
“unless
a more effective control system
is
used”
has been replaced with “unless
a control system that allows
less VON
to be emitted
is used.”
Section 215.485:
the second sentence has been rewritten
to
become:
“The repair shall
be completed
as soon as
practicable
but no later than
15 days after
the leak is
found.
If
the
leaking component cannot be repaired until
the process unit is
shut down,
the leaking component must then be repaired before
the
unit
is restarted.”
Section 215.487:
“to the Agency” was added
after “demonstrate
compliance.”
Section 215.489:
“(effective date of rule)”
has been
replaced
with “April
15,
1988.”
88—13 5
—20—
ORDER
The
Clerk of
the Pollution Control Board
is directed
to
submit the following adopted
rube
to the Secretary of
State
for
Final
Notice:
TITLE
35:
ENVIRONMENTAL PROTECTION
SUBTITLE
B:
AIR POLLUTION
CHAPTER
I:
POLLUTION CONTROL BOARD
SUBCHAPTER
C:
EMISSION STANDARDS AND LIMITATIONS
FOR STATIONARY SOURCES
PART
211
DEFINITIONS AND GENERAL PROVISIONS
SUBPART A:
GENERAL PROVISIONS
Section
211.101
Incorporations by Reference
211.102
Abbreviations and Units
SUBPART B:
DEFINITIONS
Section
211.121
Other Definitions
211.122
Definitions
Appendix A
Rule into Section Table
Appendix B
Section
into Rube Table
AUTHORITY:
Implementing Sections
9 and
10 and authorized
by
Section
27 of the Environmental Protection Act
(Ill.
Rev.
Stat.
1985,
ch.
1111/2, pars.
1009,
1010 and 1027).
SOURCE:
Adopted
as Chapter
2:
Air Pollution,
Rule 201:
Definitions,
R7l—23,
4 PCB
191,
filed
and effective April
14,
1972; amended
in R74—2 and R75—5,
32 PCB 295, at
3
Ill.
Reg.
5,
p.
777, effective February
3,
1979;
amended
in R78—3
and
4,
35
PCB 75 and 243,
at
3
Ill.
Peg.
30,
p.
124, effective July
28,
1979;
amended
in P80—5,
at
7
Ill.
Peg.
1244,
effective January
21,
1983;
codified
at
7
Ill.
Peg.
13590;
amended
in P82—b
(Docket
A)
at
10
Ill.
Reg.
12624, effective July
7,
1986;
amended
in R85—
21(A)
at
11
Ill.
Peg.
11747, effective June
29,
1987;
amended
in
P86—34 at
lb
Ill.
Peg.
12267,
effective July
10,
1987;
amended
in
P86—39 at
11
Ill.
Peg.
20804, effective December
14,
1987;
amended
in R82—l4 and R86—37
at
12
111.
Peg.
787,
effective
December
24,
1987;
amended
in P86—10 at 12
Ill.
Peg.
___
effective
_______________________
88—136
-21—
SUBPART A:
GENERAL PROVISIONS
Section
211.122
Definitions
“In—Process Tank”:
A container
used for mixing,
blending, heating,
reacting, holding, crystallizing,
evaporating,
or cleaning operations
in
the manufacture
of pharmaceuticals.
“Pharmaceutical”:
Any compound
or mixture,
other
than
food,
used
in
the
prevention,
diagnosis,
alleviation,
treatment
or cure of disease
in man and
animal.
“Production Equipment Exhaust System”:
A system
for
collecting
and directing
into
the atmosphere emissions
of volatile organic material
from reactors,
centrifuges
and other process emission sources.
“Reactor”:
A vat,
vessel
or other device
in which
chemical
reactions
take place.
“Surface Condenser”:
A device which
removes
a substance
from
a
gas
stream
by
reducing
the
temperature
of
the
stream, without direct contact between
the coolant and
the stream.
(Source:
Amended
at
Ill.
Peg.
effective
________________
TITLE
35:
ENVIRONMENTAL PROTECTION
SUBTITLE B:
AIR POLLUTION
CHAPTER
I:
POLLUTION CONTROL BOARD
SUBCHAPTER
C:
EMISSIONS STANDARDS AND LIMITATIONS FOR
STATIONARY SOURCES
PART 215
ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS
SUBPART A:
GENERAL PROVISIONS
Section
215. 100
Introduction
215.101
Clean—up and Disposal Operations
215.102
Testing
Methods
215.103
Abbreviations
and
Conversion
Factors
215.104
Definitions
215.105
Incorporations by Reference
215.106
Afterburners
215.107
Determination of Applicability
SUBPART
B:
ORGANIC
EMISSIONS FROM STORAGE
AND LOADING OPERATIONS
88—137
—22—
Storage Containers
Loading
Operations
Petroleum Liquid
Storage Tanks
External Floating Roofs
Compliance Dates
and Geographical
Areas
Compliance
Plan
SUBPART
C:
ORGANIC EMISSIONS FROM
MISCELLANEOUS EQUIPMENT
Separ ation
Oper at ions
Pumps and Compressors
Vapor Bbowdown
215.144
Safety Relief Valves
SUBPART E:
SOLVENT CLEANING
Section
215.202
215.204
215.205
215. 206
215. 207
215.208
215.209
215. 210
215. 211
215.212
215. 213
Section
215.240
215.245
215.241
215.249
Section
215.121
215.122
215.
123
215.124
215.125
215.126
Section
215.141
215.142
215. 143
Section
215. 181
215. 182
215. 183
215. 184
215.185
Solvent Cleaning
in General
Cold Cleaning
Open
Top
Vapor
Degreasing
Conveyorized Degreasing
Compliance Plan
SUBPART F:
COATING OPERATIONS
Compliance
Schedules
Emission Limitations
for Manufacturing Plants
Alternative Emission Limitations
Exemptions
from Emission Limitations
Compliance by Aggregation of Emission Sources
Testing Methods
for Solvent Content
Exemption from General Rule on Use of Organic
Material
Alternative Compliance Schedule
Compliance Dates
and Geographical Areas
Compliance Plan
Special
Requirements for Compliance Plan
SUBPART
H:
SPECIAL LIMITATIONS FOR SOURCES
IN MAJOR URBANIZED AREAS WHICH ARE
NONATTAINtIENT FOR OZONE
Applicability
Fbexographic
and Rotogravure Printing
External Floating Roofs
Compliance Dates
88—138
—23—
SUBPART
K:
USE
OF ORGANIC MATERIAL
Section
215. 301
215.302
215.303
215.304
215.305
Use of Organic
Material
Alternative Standard
Fuel Combustion Emission Sources
Operations with Compliance Program
Viscose Exemption
(Repealed)
SUBPART
N:
VEGETABLE OIL PROCESSING
Section
215.340
215.342
215.344
215.345
215.346
215.347
Section
215.401
215.402
215.403
Section
215.404
215.405
215.406
215.407
215.408
Hexane Extraction Soybean Crushing
Hexane Extraction
Corn Oil Processing
Recordkeeping
for Vegetable Oil Processes
Compbiance Determination
Compliance Dates and Geographical
Areas
Compliance
Plan
SUBPART
P:
PRINTING AND PUBLISHING
Flexographic
and Rotogravure Printing
Exemptions
Applicability of Subpart
K
Testing
and Monitoring
Compliance
Dates
and
Geographical
Areas
Alternative Compliance Plan
Compliance Plan
Heatset Web Offset Lithographic Printing
Applicability
General Requirements
Inspection Program Plan for Leaks
Inspection
Program
for
Leaks
Repairing
Leaks
Pecordkeeping
for
Leaks
Reporting
for Leaks
Alternative Program
for Leaks
Compliance Dates
Compliance Plan
General Requirements
Inspection Program Plan
for Leaks
Inspection Program
for Leaks
Repairing
Leaks
SUBPART
Q:
LEAKS FROM SYNTHETIC ORGANIC CHEMICAL AND
POLYMER ~4ANUFACTURING EQUIPMENT
Section
215.420
215.421
215.422
215.423
215.424
215.425
215.426
215.427
215.428
215.429
215.430
215.431
215.432
215.433
88—139
—24—
SUBPART
R:
PETROLEUM
REFINING
AND
RELATED
INDUSTRIES;
ASPHALT
MATERIALS
Petroleum Refinery Waste Gas Disposal
Vacuum Producing Systems
Wastewater
(Oil/Water) Separator
Process Unit Turnarounds
Leaks General Requirements
Monitoring Program Plan for Leaks
Monitoring Program
for Leaks
Recordkeeping
for Leaks
Reporting
for Leaks
Alternative Program for Leaks
Sealing Device Requirements
Compliance
Schedule
for
Leaks
Compliance
Dates
and
Geographical
Areas
SUBPART
S:
RUBBER AND MISCELLANEOUS
PLASTIC PRODUCTS
Manufacture of Pneumatic Rubber
Tires
Green Tire Spraying Operations
Alternative Emission Reduction Systems
Testing
and Monitoring
Compliance Dates and Geographical Areas
Compliance Plan
SUBPART
T:
PHARMACEUTICAL MANUFACTURING
Section
215.480
215.481
215.482
215.483
215.484
215.485
215.486
215. 487
215.488
215.489
Applicability of Subpart
T
Control
of Reactors,
Distillation Units, Crystallizers,
Centrifuges and Vacuum Dryers
Control
of Air Dryers, Production Equipment Exhaust
Systems and Filters
Material Storage
and Transfer
Tn—Process
Tanks
Leaks
Other Emission Sources
Testing
Monitors for Air Pollution Control Equipment
Compliance
SUBPART
U:
COKE MANUFACTURING AND
Recordkeeping
for Leaks
Report
for Leaks
Alternative Program
for Leaks
Open—Ended Valves
Compliance Plan
215.434
215.435
215.436
215.437
215.438
Section
215.441
215.442
215.443
215.444
215.445
215.446
215.447
215.448
215.449
215. 450
215. 451
215.452
215.453
Section
215.461
215.462
215.463
215.464
215.465
215.466
88—140
—25—
BY-PRODUCT RECOVERY
Section
215. 500
215. 510
215. 512
215. 513
215. 514
215.515
215.516
215.517
Exception
Coke By—Product Recovery Plants
Coke By—Product Recovery Plant Leaks
Inspection
Program
Pecordkeeping Requirements
Reporting Requirements
Compliance Dates
Compliance Plan
SUBPART
V:
AIR OXIDATION PROCESSES
Applicability
Definitions
Emission Limitations for Air Oxidation Processes
Testing
and Monitoring
Compliance Date
SUBPART W:
AGRICULTURE
Section
215.541
Pesticide Exception
SUBPART
X:
CONSTRUCTION
Architectural Coatings
Paving Operations
Cutback Asphalt
Bulk Gasoline Plants
Bulk Gasoline Terminals
Gasoline Dispensing Facilities
Gasoline Delivery Vessels
Section
215.601
215.602
215.603
215.604
215.605
215.606
215.607
215.608
Perchboroethylene Dry Cleaners
Exemptions
Testing
and Monitoring
Compliance Dates
and Geographical
Areas
Compliance Plan
Exception
to Compliance Plan
Standards
for Petroleum Solvent Dry Cleaners
Operating Practices for Petroleum Solvent Dry Cleaners
Section
215.520
215. 521
215.525
215.526
215.527
Section
215.561
215.562
215.563
Section
215. 581
215.582
215.583
215.584
SUBPART
Y:
GASOLINE DISTRIBUTION
SUBPART
Z:
DRY CLEANERS
88—141
—26—
215.609
Program
for Inspection and Repair
of Leaks
215.610
Testing and Monitoring
215.611
Exemption for Petroleum Solvent Dry Cleaners
215.612
Compliance Dates
and Geographical
Areas
215.613
Compliance
Plan
SUBPART BB:
POLYSTYRENE PLANTS
Section
215.875
Applicability of Subpart BB
215.877
Emissions Limitation
at Polystyrene Plants
215.879
Compliance Date
215.881
Compliance
Plan
215.883
Special Requirements
for Compliance Plan
215.886
Testing
and Monitoring
Appendix A
Rule into Section Table
Appendix
B
Section
into Rule Table
Appendix
C
Past Compliance
Dates
Appendix
D
List of Chemicals Defining Synthetic Organic
Chemical and Polymer Manufacturing
Appendix
E
Reference Methods
and Procedures
Appendix
F
Coefficients
for the Total Resource Effectiveness
Index
(TRE)
Equation
AUTHORITY:
Implementing Section
10 and authorized
by Section 27
of the Environmental Protection Act (Ill.
Rev.
Stat.
1985,
ch.
1111/2 pars.
1010
and 1027).
SOURCE:
Adopted
as Chapter
2:
Air Pollution,
Rube
205:
Organic
Material Emission Standards
and Limitations, P71—23,
4 PCB 191,
filed
and effective April
14,
1972;
amended
in P77—3,
33 PCB
357,
at
3
Ill.
Peg.
18,
p.
41, effective May
3,
1979; amended in P78—3
and P78—4,
35 PCB 75, at
3
Ill.
Peg.
30,
p.
124, effective July
28, 1979;
amended
in P80—S
at
7
Ill.
Peg.
1244, effective January
21,
1983;
codified at
7
Ill.
Peg.
13601;
Notice of Corrections at
7
Ill.
Peg.
14575; amended
in P82—14 at
8 Ill.
Reg.
13254,
effective July 12,
1984;
amended
in P83—36
at
9
Ill.
Peg.
9114,
effective May
30,
1985; amended
in R82—b4 at
9
Ill.
Peg.
13960,
effective August
28,
1985; amended
in P85—28
at
lb Ill.
Peg.
3127,
effective
February
3,
1987;
amended
in P82—14 at lb
Ill.
Peg.
7296, effective
April
3,
1987;
amended
in
P85—21(A)
at
lb
Ill.
Peg.
11770, effective June
29,
1987;
recodified
in P86—39 at
11
Ill.
Peg.
13541;
amended
in P82—14 and P86—12 at
11
Ill.
Peg.
16706, effective September
30,
1987;
amended
in P85—21(B)
at
11
Ill.
Reg.
19117, effective November
9,
1987;
amended
in P86—36,
P86—39,
P86—40
at 11
Ill.
Peg.
20829, effective December
14,
1987;
amended
in P82—14 and P86—37
at
12.
Ill.
Peg.
815,
effective December
24,
1987; amended
in P86—10
at
12
Ill.
Peg.
_______,
effective
______________________
88-142
—27—
SUBPART A:
GENERAL PROVISIONS
Section 215.102
Testing Methods
a)
The
total organic material concentrations
in
an effluent
stream shall
be measured by
a flame
ionization detector,
or by other methods approved
by the Illinois Environ-
mental
Protection Agency (Agency)
,
according
to the
provisions of
35 Ill.
Adm.
Code 201.
b)
Measurement of Vapor
Pressures
1)
For
a single—component,
the actual vapor pressure
shall be determined by ASTM (American Society of
Testing and Materials) Method D—2879—83
(Approved
1983),
incorporated by reference
in Section
215.105,
or the vapor pressure may be obtained
from
a published
source such as:
Boublik,
T.,
V.
Fried
and
E.
Hala,
“The Vapor Pressure of Pure
Substances,”
Elsevier Scientific Publishing
Co.,
New York
(1973), Perry’s Chemical Engineer’s
Handbook,
McGraw—Hill Book Company
(1984),
CRC
Handbook of Chemistry and Physics, Chemical Rubber
Publishing Company
(1986—87),
Lange’s Handbook of
Chemistry,
John
A.
Dean, editor, McGraw—Hill Book
Company
(1985).
2)
For a mixture, the actual vapor pressure shall
be
determined
by ASTM (American Society of Testing
and
Materials)
Method D—~~92879—83(Approved 1983),
incorporated by reference
in Section 215.105, or
the vapor pressure may be taken as either:
A)
If the vapor pressure of the e~n~ie
~e~ai
e~volatile organic
m
ef~e~liquid
is no~
specified
in
the applicable rule,
the lesser
of
the
sum
of
the
actual
vapor
pressure
of
each component or each volatile organic
material
component,
as determined
in
accordance with 215.102(b) (1), weighted by its
mole
fraction;
or
B)
If the vapor pressure of the organic material
or
volatile
organic
material
is
specified
in
the applicable
rule,
the sum of
the
actual
vapor pressure of each such component as
determined
in accordance with 2l5.102(b)(1)
weighted by its mole
fraction.
Section 215.105
Incorporations by Reference
The following materials
are incorporated by reference:
88—143
—28—
a)
American Society
for Testing
and Materials,
1916 Race
Street,
Philadelphia,
PA 19103:
1)
ASTM
D 1644—59 Method
A
2)
ASTM
D 1475—60
3)
ASTM D 2369—73
4)
ASTM
D 2879—83
(Approved 1983)
5)
ASTM D 323—82
(Approved
1982)
6)
ASTM
D
86—82
(Approved 1982)
7)
ASTM
E 260—73
(Approved 1973),
E 168—67
(Reapproved
1977),
E 169—63
(Reapproved 1981),
E
20
(Approved 1985)
8)
ASTM D 97—66
9)
ASTM
D 1946—67
10) ASTM
D 2382—76
b)
Federal Standard l4la,
Method 4082.1
c)
National Fire Codes, National Fire Prevention
Association,
Battery March Park, Quincy, Massachusetts
02269
(1979)
d)
United States Environmental Protection Agency,
Washington,
D.C., EPA—450/2—77—026,
Appendix A.
e)
United States Environmental Protection Agency,
Washington,
D.C.,
EPA—450/2—78—05l Appendix A and
Appendix
B (December
1978).
f)
Standard Industrial Classification Manual,
published by
Executive Office of
the President, Office of Management
and Budget,
Washington,
D.C.,
1972
~j
40 CFR 60, Appendix
A,
1986
h)
United States Environmental Protection Agency, Washington
D.C.,
EPA—450/2—78—04l.
(Board Note:
The incorporations by reference listed above
contain
no later amendments or editions.)
(Source:
Amended at
___
Ill.
Reg.
________
88—144
—29—
effective
_________________
SUBPART
T:
PHARMACEUTICAL
MANUFACTURING
Section
215.480
Applicability
of
Subpart
T
a)
The rules of
this Subpart, except
for Sections 215.483
through 215.485, apply
to all emission sources of
volatile organic material,
including but not limited
to
reactors, distillation
units,
dryers,
storage tanks
for
volatile organic liquids, equipment
for
the transfer
of
volatile organic liquids,
filters, crystallizers,
washers,
laboratory hoods,
coating oDerations,mixing
operations and centrifuges
used
in manufacturing,
including packaging,
of pharmaceuticals,
and emitting
more than
6.8 kg/day
(15
lbs/day)
of volatile organic
material
and more
than 2268 kg/year
(2.5 tons/year)
of
volatile organic material, or,
if less than 2.5
tons/year,
these
sections still
apply if emissions from
any single source exceed 45.4 kg/day
(100
lbs/day).
b)
The following
emissions shall
be excluded
from
a
determination of what constitutes more than
2268 kg/year
(2.5 tons/year)
of VON for the purposes of
subsection
(a)
above:
not more than 4535 ky/year
(5.0
tons/year)
of volatile organic material from each fluid
bed drier
or each tunnel drier, and not more than 6803 kg/year
(7.5 ton/year)
of VON from each Accelacota.
This
subsection
shall apply only to fluid
bed driers, tunnel
driers and Accelacotas located
in
Libertyville Township,
Lake County,
Illinois, and only when such emissions are
not vented
to
air pollution control equipment.
c)
Sections 215.483 through
215.485 apply to
a plant having
one or more emission sources
that:
1)
are used
to manufacture pharmaceuticals;
and
2)
emit more than 6.8 kg/day
(15
lbs/day)
of volatile
organic material
and more than 2268 kg/year
(2.5
tons/year)
of volatile organic material, or,
if
less than 2.5 tons/year,
these sections still apply
if emissions
from one or more sources exceed 45.4
kg/day (100
lbs/day).
d)
No person shall violate any condition
in
a permit when
the condition results
in exclusion of an emission source
from this Part 215,
Subpart
T.
(Source:
Added
at
Ill.
Peg.
________,
effective
88—145
—30—
Section 215.481
Control
of Reactors, Distillation Units,
Crystallizers, Centrifuges and Vacuum Dryers
a)
The owner
or operator
shall equip all reactors,
distillation units, crystallizers, centrifuges and
va~cuumdryers that are used
to manufacture pharmaceu-
ticals with surface condensers operated such that the
condenser outlet gas temperature does not exceed:
1)
248.2
K
(—13
F) when condensing volatile organic
material
of vapor pressure greater
than 40.0 kPa
(5.8 psi)
at 294.3
K
(70 F);
or
2)
258.2
K
(5
F)
when condensing volatile organic
material
of vapor pressure greater
than 20.0 kPa
(2.9 psi)
at 294.3
K
(70 F);
or
3)
273.2
K
(32
F)
when condensing
volatile
organic
material
of vapor pressure greater
than 10.0 kPa
(1.5 psi)
at 294.3
K
(70 F);
or
4)
283.2
K
(50
F) when condensing volatile organic
material
of vapor pressure greater
than 7.0 kPa
(1.0 psi)
at 294.3
K
(70 F);
or
5)
298.2
K
(77
F)
when condensing volatile organic
material
of vapor pressure greater
than 3.45 kPa
(0.5 psi)
at 294.3
K
(70 F).
b)
The owner
or operator shall
enclose all centrifuges used
to manufacture pharmaceuticals and
that have
an exposed
volatile organic liquid surface, where
the volatile
organic material
in the volatile organic liquid has a
vapor pressure of
3.45 kPa (0.5 psi)
or more
at 294.3
K
(70 F).
c)
The owner
or operator shall enclose
all centrifuges used
to manufacture pharmaceuticals
and that have an exposed
volatile organic
liquid surface, where the volatile
organic material
in the volatile organic liquid has a
vapor pressure of
3.45 kPa
(0.5 psi)
or more at 924.3
K
(70 F).
(Source:
Added
at
Ill. Peg.
________,
effective
__________
Section
215.482
Control
of Air Dryers,
Production Equipment
Exhaust Systems and
Filters
a)
The owner
or operator of an
air dryer
or production
equipment
exhaust
system used
to manufacture pharma-
ceuticals
shall control
the emissions of volatile
88—146
organic
material
from
such
emission
sources
by
air
pollution control
eauipment
which reduces by
90 percent
or more
the volatile organic material
that would other-
wise
be emitted
into
the atmosphere.
b)
The owner
or operator shall
enclose
all rotary vacuum
filters
and other
filters used
to manufacture pharma-
ceuticals and
that have
an exposed volatile organic
liquid
surface, where the volatile organic material
in
the volatile organic liquid has
a vapor pressure of 3.45
kPa
(0.5 psi)
or more
at
294.3
K
(70 F).
(Source:
Amended at
Ill.
Peg.
,
effective
______________
Section 215.483
Material Storage
and Transfer
The owner
or operator of
a pharmaceutical manufacturing plant
shall:
a)
Provide
a vapor balance
system or equivalent control
system that
is at
least
90.0 percent effective
in
reducing volatile organic material emissions from truck
or
railcar deliveries
to stora~etanks with capacities
equal
to
or greater
than 7.57m3
(2,000 gallons)
that
store volatile organic liquids
with vapor pressures
greater
than 28.0 kPa
(4.1
psi)
at 294.3
K
(70 F); and
b)
Install pressure/vacuum conservation vents set at
0.2
kPa
(0.03 psi)
on all storage
tanks
that store volatile
organic liquids with vapor pressures greater
than
10 kPa
(1.5 psi)
at 294.3
K
(70 F),unless a control system that
allows less VON
to be emitted
is
used.
(Source:
Added
at
Ill.
Reg.
effective
______________
Section 215.484
In—Process Tanks
The owner
or operator shall
install covers on all in—process
tanks used
to manufacture pharmaceuticals
and containing
a
volatile organic liquid
at any time.
These covers must remain
closed, except when production, sampling, maintenance,
or
inspection procedures require operator access.
(Source:
Added
at
Ill.
Peg.
________,
effective
______________
Section
215.485
Leaks
The owner
or operator
of
a pharmaceutical manufacturing plant
shall
repair any component
from which
a beak
of volatile organic
88—14 7
—32—
liquid
can be observed.
The
repair
shall
be completed
as soon
as
practicable but
no later
than
15 days after
the leak
is
found.
If the leaking component cannot be repaired until
the process
unit
is shut down,
the leaking component must then be repaired
before the unit
is restarted.
(Source:
Added
at
Ill.
Peg.
,
effective
______________
Section
215.486
Other Emission Sources
The owner or operator of
a washer, laboratory hood,
capsule
coating
operation, mixing operation,
or
any other process
emission source not subject
to Section 215.481 through 215.485
of
this Subpart, and used
to manufacture pharmaceuticals
shall
control
the emissions
of volatile organic material
from such
emission sources by:
a)
Air pollution control equipment which reduces by 81
percent
or more
the volatile organic material
that would
otherwise
be emitted
to
the atmosphere, or
b)
A surface condenser which captures all the volatile
organic material which would otherwise be emitted
to
the
atmosphere
and
which
meets
the requirements of Section
215.481(a)
of this Subpart.
(Source:
Added
at
Ill.
Reg.
,
effective
_______________
Section
215.487
Testing
a)
The owner or operator
of any volatile organic material
emission source subject
to this Subpart shall, at his
own expense, demonstrate compliance
to
the Agency by
methods or procedures listed
in Section 215.487(c).
b)
All
tests pursuant
to Section 215.487(a)
shall
be
performed
in conformance with the procedures
set forth
in
35
Ill. Adm.
Code
283.
c)
Test procedures
to determine
operation
and maintenance
compliance with
this Subpart
shall
be consistent with
EPA—450/2—78—04l,
incorporated
by reference
in Section
215.105.
Procedures
for testing
air pollution control
equipment
to determine compliance with this Subpart
shall
use Part
230,
Appendix A Method
25
(40 CFR
60,
Appendix A Method 25).
(Source:
Added
at
Ill.
Peg.
________,
effective
______________
88—148
—33—
Section 215.488
Monitors
for Air Pollution Control
Equipment
a)
At
a
minimum,
continuous
monitors
for
the
following
parameters
shall
be
installed
on
air
pollution
control
equipment subject
to this Subpart:
1)
Destruction device combustion temperature
2)
Temperature
rise
across
a
catalytic
afterburner
bed
3)
Breakthrough of volatile organic material on
a
carbon adsorption
unit.
b)
Each monitor
shall
be equipped with
a recording device.
c)
Each monitor
shall
be calibrated quarterly.
d)
Each monitor
shall operate
at all
times while
the
associated
control
equipment
is operating.
(Source:
Added
at
Ill. Peg.
effective
______________
Section 215.489
Compliance Schedule
a)
The owner
or operator of an
emission source subject
to
this Subpart,
the construction or modification of which
has commenced prior
to April
15,
1988 must complete on—
site construction
or installation
of the emission
contro1~or process equipment,
or both,
so as to operate
in compliance with this Subpart by April
1,
1989.
b)
The owner
and operator of any emission source subject
to
this Subpart, the construction
or modification of which
has not commenced prior
to April
15,
1988,
shall
construct such source
so that it will operate
in
compliance with this Subpart.
(Source:
Added
at
Ill.
Peg.
________,
effective
_____________
IT
IS SO ORDERED
I,
Dorothy M.
Gunn,
Clerk of the Illinois Pollution Control
Board, hereby certify that the abov~Opinion
and Order was
adopted
on the
7~
day of ________________________,
1987,
by a
vote of
7—c
.
Dorothy M.
cXinn,
Clerk
Illinois Pollution Control
Board
88—149
