ILLINOIS POLLUTION CONTROL BOARD
January
25,
1990
)
IN THE MATTER OF:
)
)
P88-14
AMENDMENTS TO 35
ILL. ADM.
)
(Rulemaking)
CODE 211 AND 215
(PHARMACEUTICALS)
Proposed
Rule.
First Notice.
OPINION AND ORDER OF
THE BOARD
(by J.O. Dumelle):
This matter comes before the Board upon Abbott
Laboratories’
Amended
Petition for Rulemaking and Motion for Expedited Hearing
filed
on December
4,
1989.
On December
20,
1989,
the
Board granted Abbott’s motion for expedited
proceeding
insofar
as
it
is practicable
in
light
of
the Board’s current
schedule
and workload
and directed the hearing officer
to schedule hearings.
Hearings have been scheduled for March
3 and
28,
1990.
So
as
to begin the Administrative Procedure ~ctrulemaking process, the
Board
today proposes Abbott’s amended proposal
for
first notice.
However,
the
Board takes no position on the merits
of the proposal
at this time.
The
Board’s action today
is taken to effectuate the publication
of
the proposal
in
the Illinois Register.
Finally,
the Board also decides
today that
an Economic Impact
Study
(EcIS)
need not be prepared
by the Department of Energy and Natural Resources
(DENR).
The Board makes this determination based upon comments
filed
by the
Agency and by Abbott earlier
in this proceeding.
The Agency
is
of the opinion
that,
in
light
of the fact that this
is
a site—specific proposal affecting
only one facility and that substantial
information
is already available from
the pharmaceuticals rulemaking
(R86—1O), preparation of
an EcIS ~vould
be
inappropriate.
Abbott
also believes
that an EcIS need not
be prepared, based
upon the
record developed
in R86—1O and
its projection
of
the course
of this
rulemaking.
The Board
agrees with Abbott
and the Agency on this issue.
As
an aside,
the Board
notes that
the timing
of
this EcIS decision
is
in
no way related
to
the filing
of the amended petition.
It
is only the result
of the unusual
history
of this particular proceeding
that the
EcIS decision
was not previously made.
ORDER
The Board
hereby proposes
the following amendments for first notice.
TITLE
35:
ENVIRONMENTAL PROTECTION
SUBTITLE
B:
AIR POLLUTION
CHAPTER
1:
POLLUTION CONTROL BOARD
107—259
—2—
SUBCHAPTER
C:
EMISSION STANDARDS AND LIMITATIONS FOR
STAFIONARY SOURCES
PART 211
DEFINITIONS AND GENERAL PROVISIONS
SUBPART B:
DEFINITIONS
Section
211.121
Other Definitions
211.122
Definitions
AUTHORITY:
implementing Sections 9 and 10 and authorized
by Section
27
of
the
Environmental Protection Act
(Ill.
Rev.
Stat.
1987,
ch.
111½,
pars.
1009,
1010
and
1027).
SOURCE:
Adopted
as Chapter
2:
Air Pollution,
Rule 201:
Definitions, R71-23,
4 PCB
191,
filed and effective April
14,
1972;
amended
in P74—2 and
P75—5,
32
PCB 295, at
3
111.
Reg.
5,
p.
777, effective February
3,
1979;
amended
in P78—
3 and
4,
35 PCB
75 and 243,
at
3
Ill.
Reg.
30,
p.
124, effective July 28,
1979;
amended
in P80-5,
at
7
Ill.
Reg.
1244, effective January
21,
1983;
codified at
7
Ill.
Peg.
13590;
amended
in R82-1
(Docket A)
at
10
11.
Reg.
12624, effective July
7,
1986;
amended
in P85-21(A)
at
11
Ill.
Peg. 11747,
effective June 29,
1987;
amended
in P86—34
at
11
Ill. Peg.
12267, effective
July
10,
1987;
amended
in P86-39
at
11
Ill.
Peg.
20804, effective December 14,
1987;
amended
in
R82-14 and P86-37
at
12
Ill.
Reg.
787, effective December 24,
1987;
amended
in P86—18
at
12
111.
Peg.
7284, effective April
8,
1988;
amended
in P86-10
at
12
Ill
Peg.
7621, effective April
11,
1988; amended
in R88-23
at
13
Ill.
Peg.
10862, effective June 27,
1989; amended
in P88—14
at
____
Ill.
Peg.
_________
,
effective __________________________
SUBPART B:
DEFINITIONS
Section 211.122
Definitions
Production Equipment Exhaust System:
a system fe~ee44eet4nq a~d
d4~eet4~
4ntG the at~iosphe~ee~5ss4e~s
ef veTati4e e~ie ~ate~ia4
f~G~
~eaete~see~tr4~gesa~dether ~~?ess
e~4ss4ense~eesof
fans
and fixed
or moveable ducts,
pickup points and hoodinq,
for purposes
of
industrial
hygiene
or good practice, which collect materia~sfrom
openings ann other cDerations
of reactors, centrifuges,
and other
p~pçessemission
sources,
.hich materials
are not ducted
to the
atmosphere through direct vents extending from the
interior of
the
reactor,
centrifuge,
or process emission source.
~aboratoryhoods,
roof monitors and general
building exhausts shall
not
he considered
production equipment exhaust systems.
(Source:
Amended
at
Ill.
Peg.
_______
,
effective
_______
TITLE
35:
ENVIRONMENTAL PROTECTION
SUBTITLE
B:
AIR POLLUTION
CHAPTER
I:
POLLUTION CONTROL BOARD
j
C;
7—260
—3—
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
C~ean-upand 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 T:
PHARMACEUTICAL MANUFACTURING
Section
215.480
Applicability of
Subpart T
215.481
Control
of Reactors, Distillation Units, Crystallizers,
Centrifuges and Vacuum Dryers
215.482
Control
of Air Dryers, Production Equipment Exhaust Systems and
Filters
215.483
Material Storage and Transfer
215.484
In-Process Tanks
215.485
Leaks
215.486
Other Emission Sources
215.487
Testing
215.488
Monitors for Air Pollution Control Equipment
215.489
Compliance
Schedule
AUTHORITY:
Implementing Section
10 and authorized
by Section
27
of the
Environmental Protection Act
(Ill.
Rev.
Stat.
1987,
ch.
111½ pars.
1010
and
1027).
SOURCE:
Adopted
as Chapter
2:
Air Pollution, Rule
205:
Organic Material
Emission Standarns and Limitations, R71—23,
4 PCB 191,
filed and effective
April
14.
1972; amended
in P77—3,
33 PCB
357,
at
3
11.
Peg.
18,
p.
41,
effective ~ay 3,
1979;
amended
in P78—3
and P78-4,
35 PCB 75,
at
3
111. Peg.
30,
p.
124, effective July 28,
1979; amendec
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 P82-1°at
8
Ill.
Peg.
13254,
effective July
12,
1984;
amended
in P83-36 at
9
Ill.
Peg. 9114, effective May
30,
1985;
amended
in R82-14
at 9
Ill.
Peg.
13960, effective Auguct
28,
1985;
amended
in P85-28 at
11
111.
Peg.
3127,
effective February
3,
1987;
amended
in
P82-14
at
11
Ill.
Peg.
7296,
effective April
3,
1987;
amended
in P85-21(A)
at
11
111.
Peg.
11770, effective June 29,
1987;
recodified
in P86—39
at
ii
Ill.
Req.
13541;
amended
in R82-14 and P86-12
at
11
Ill.
Peg.
16706, effective
September 30,
1987;
amended
in R85-21(B)
at
11
Ill.
Peg.
19117, effective
107—261
-4-
November 9,
1987;
amended
in P86—36,
P86-39, R86—4O
at
11
Ill.
Peg. 20829,
effective December 14,
1987;
amended
in R82-14 and R86-37
at
12
Ill.
Reg. 815,
effective December 24,
1987; amended
in R86-18 at
12
Ill.
Reg.
7311, effective
April
8,
1988;
amended
in R86-1O
at
12
Ill.
Peg.
7650, effective
April
11,
1988;
amended
in P88-23
at
13 Ill.
Reg.
10893,
effective June 27,
1989,
amended
in R88-14
at
Ill. Reg.
_____________
,
effective
___________
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 Environmental 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
0-2879-83 (Approved 1983),
incorporated
by reference
in
Section 215.105, or the vapor oressure 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 0-2879-
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 volatile organic liquid
is
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)(l), weighted
by
its mole
fraction excluding ~ater or
B)
I’
the vapor pressure of the organic material
or
volatile
organic material
is
specified
in
the apDlicable rule,
tne
sum of the actual
vapor pressure of each sucn component
as
determined
in accordance with 215.102(b)(i) weighted
by
its
mole fraction, excluding water.
(Source:
Amended
at
13
111.
Peg.
_____
,
effective
___________
)
SUBPART
I:
PHARMACEUTICAL MANUFACTURING
Section 215.480
Applicability of Subpart T
107—262
-5—
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
hoons,
coating operations,
mixing operations, and
centrifuges and air suspension coaters used
in manufacturing,
including packaging,
of pharmaceuticals,
and emitting more than 6.8
kg/day
(15 lbs/day)
of volatile organic materia~ 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) except
as
to
those
emission sources
subject
to
the exemptions contained in subsections
215.480(b)
and
(c).
b)
The following emissions
shall
be excluded from
a determination of
what constitutes more than 2268 kg/year (2.5 tons/year)
of VOM for
the purposes of subsecYon (a)
above:
not more than 4535 kg/year
(5.0 tons/year)
of
volatile organic material from each fluid
bed
drier, ~
each
tunnel
drier,
or
air suspension coaters,
and
not more
than 6803 kg/year
(7.5 ton/year)
of
VON from each Accelacota.
For
purposes
of this exclusion the
4535 kg,’year
(5.0
tons/year)
limitation on the eight
tunnel
dryers shall
be calculated
by
adding
the total
emissions from the eight dryers and dividing
by eight.
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.
ç~
The following emissions
shall
be excluded from
a determination of
what constitutes more than 2268j~jy~r
(2.5 tons/year)
of VOM for
the purposes of
subsection
(a)
above:
not more than 4535 kg/year
(5.0 tons/year)
of acetylene from reactor PC842 and not more than
4535 kg/year
(5.0 tons/yearj~facetone from each
of
the following:
Spectam Centrifuge, Succinate Filter Press, Reactor-Tank
37,
Centrifuge Number
4 ann Tank 48.
This subsection
shall
apply only
to
reactor PC842,
Spectan Centrifuge, Succinate Filter Press, Reactor-
Tank 37, Centrifuge
Number
4 and Tank
48
located
in Shields Township,
Lake County,
Hilnois.
~
Sections 215.483 through
215.485 apply
to
a plant having
one or more
emission sources tnat:
1)
are used
to manufacture pharmaceuticals;
and
2)
emit more than 6.8 ~g/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 app~yif emissions from one or more sources
exceed 45.4 kg/day
(100 lbs/day).
107—263
-6—
~
No person shall
violate any condition in
a permit when the condition
results
in exclusion of
an emission source from this Part 215,
Subpart I.
(Source:
Amended at
13
Ill.
Peg.
______
,
effective
_____________)
Section 215.481
Control
of
Reactors, Distillation Units,
Crystallizers, Centrifuges
and Vacuum Dryers
a)
The owner
or operato’-
shall equip
all reactors, distillation units,
crystallizers, centrifuges
and
vacuum dryers
that are used
to
manufacture pharmaceuticals with surface condensers,
scrubbers,
incinerators
or
carbon adsorbers. o~e~ated
s~ehthat the cendensec
eut~etgas ten~erat~e
dees ne~
1)
If
a surface condenser
is used,
it
shall
be operated such that the
condenser outlet gas temperature does not
exceed:
~
248.2~K(-13F)
when condensing volatile organic material
of
vapor pressure greater than 40.0 kPa (5.8 psi)
at 294.3K
(7O~F); or
~J2~
258.2°K(5~F)when condensing volatile organic material
of
vapor
pressure greater than 20.0
kPa
(2.9 psi)
at 294.3K (70~F);or
~
273.2~’K (32’F) when condensing volatile organic material
of
vapor pressure greater than 10.0 kPa
(1.5 psi) at 294.3K
(70°F); or
~4~ 283.2°K(50F) when condensing volatile organic material
of
vapor pressure greater than 7.0 kPa (1.0 psi)
at 294.3°K (7O’F);
or
~
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
(70F).
~
If
a scrubber,
incinerator
or carbon adsorber
is used
it
shall
he
operated
in
a manner which reduces
ny
81 percent o~more the volatile
organic materials that would otnerwise he emitted
to the atmosphere.
b)
The owner
or ooerator sha~lenclose
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).
(Source:
Amended
at
13
Ill.
Peg.
_______
,
effective
_____________
)
Section 215.486
Other Emission Sources
107—2f
—7—
The owner or operator of
a washer, laboratory hood,
eapsu3e ~
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 condense~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:
Amended
at
13
Ill.
Peg.
_______
,
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)
P.11 tests pursuant
to Section 215.487(a)
shall
be performed in
conformance with
the procedures set forth
in
35
Ill.
Admn. Code 283.
c)
Test pProcedures
to determine operation and maintenance compliance
with this Subpart
sha1l
be consistent with EPA—450/2-78—04l,
incorporated
by
reference in Section 215.105,T
P~oeed~esfo~
test4ng a4F ~o~4ut4oncontro3 equ4pment to dete~4neeom~T4aneew4th
th4s ~~ia~t sha44 use Part 230, Appendix A Method
25
(40 CFR 60,
Appendix A Method 25), material balances, or Control of Volatile
Organic Emissions from Manufacture
of Synthesized Pharmaceutical
Products, Appendix
B
(EPA-450/2-78-029) herein
incorporated
by
reference.
(Source:
Amended
at
13
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
19~June
30,
1990,
must complete on-site construction or
installation of the emission control
or
process equipment,
or both,
so
as
to operate
in compliance with this Subpart
by ApF4~15.~.4~9
December 31,
1991.
b)
The owner and operator
of any emission source subject to this
Subpart,
the construction or modification of which has
not commenced
prior
to A~4T~
49~June 30,
1990,
shall
construct such source
so
that it will operate
in compliance with this Subpart.
(Source:
Amended
at
Ill.
Peg.
,
effective
_______
)
107—265
-8-
IT
IS SO ORDERED.
I, Dorothy M.
Gunn, Clerk of the Illinois Pollution Control
Board,
hereby
cer~i-~ythat the above Opinion and Order was adopted on the
~
day
of
~
,
1990 by a vote of
________________
.
.1
.
-
~
.~-.
/~i
~
.
~
~DorothyM. ~nn, C1erk
Illinois Pollution Control Board
107—266