ILLINOIS POLLUTION COi~TROLBOARD

August

6,

1987

IN THE MATTER OF:

AMENDMENTS TO

 35 ILL.

 ADM. CODE

)

 R86-lO

211

 & 215 ORGANIC MATERIAL EMISSION

STANDARDS AND LIMITATIONS FOR

)

SYNTHESIZED PHARMACEUTICAL

MANUFACTURING PLANTS.

PROPOSED RULE.

 FIRST NOTICE.

ORDER OF THE BOARD

 (by J.D.

 Dumelle):

Tnis matter comes

 before the Board

 upon

 a February

26,

 1966,

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,

 1987,

in Waukegan.

 The Agency filed

 a second amended proposal

 on July

27,

 1987.

 A second hearing

 is scheduled

 for August

25,

 1987,

ano

additional hearings may

 be necessary.

However, certain deadlines imposed

 by the Clean Air Act

require

 that the Board quickly teach

 a final disposition

 of this

matter.

 The Board,

 accordingly,

 takes

 its action today

 to allow

that

 the activities associated with first notice may proceed

concurrently with

 the final submissions of

 information and

comments which

 the interested entities are expected

 to make

 over

the next several weeks.

 In taking this action, the Board

believes

 tnat whatever

 the outcome,

 final disposition of

 tr1is

matter will proceed

 in as timely

 a fashion

 as possible,

 to the

benefit

 of all concerned.

 The Board cautions that this action

in

no way constitutes

 a determination

 by the Board

 on the ultimate

merits

 of the proposed amendments.

The overriding

 basis

 of the Agency’s proposal

 is to correct

deficiencies

 in the Illinois State Implementation Plan

 (SIP)

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 May 19,

 1978,

 USEPA gave notice that the SIP must

include,

 at least

 for major urban areas, enforceable regulations

reflecting

 the application

 of RACT

 to those stationary sources

for which USEPA has published control techniques guidelines

(CTGs) since

 1978.

 In December,

 1978,

 a CTG was published

80—211

entitled “Control of volatile Organic Emissions from Manufacture

of Synthesized Pharmaceutical Products.”

On April

3,

 1960,

 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 RACT 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

 to disapprove Illinois’ Part D stationary source

control strategy

for

 failure

 to meet the RACT

 II control

requirements, noting that the synthetic pharmaceutical sources

were left unregulated.

To remedy

 the deficiencies noted

 in USEPA’s proposed

disapproval,

 the Agency filed

 its proposal

 of February

26,

1986.

 The proposal was amended on April

23,

 1987,

 to remove the

distinction between

 “synthesized’1 pharmaceuticals and non-

synthesized pharmaceuticals.

 Although emission sources used in

manufacturing synthesized pharmaceuticals were described in the

CTG and those used in non—synthesized pharmaceuticals were not,

the Agency

 found this distinction unimportant from

 a regulatory

standpoint because both

 kinds of sources produce emissions that

are reasonably controlled by

 similar equipment.

The Agency’s second proposed amendment,

 filed July 27,

 1987,

responded to concerns addressed at the June

9,

 1987,

 hearing.

This proposal incorporates the results of

 a study undertaken by

Mr.

 Thomas

C.

 Ponder, Jr.,

 of PEI Associates.

Mr.

 Ponder

determined that

 some sources emit more than 15 lbs/day when

in

operation,

 but only operate

a

 few days each year.

 Believing

 that

it would

not

 be cost-effective to require such sources

 to add

controls, Mr.

 Ponder concluded that an annualization of

 the 15

lbs/day limit was necessary

 arid appropriate.

 Based

 on Mr.

Ponder’s conclusions,

 the Agency amended the applicability of the

proposed

 rules

 to sources emitting volatile organic material

in

amounts exceeding 2.5 tons/year

 (i.e.,

 the annual total

of

a

15

lbs/day limit).

Thus,

 without rendering any opinion as

 to the merits

of

proposed amendments,

 the Board proposes for First Notice the

language contained

 in the Agency’s second amended proposal.

ORDER

The Board hereby proposes the following amendments for first

notice publication.

 The Clerk

 shall cause

 first notice

publication

 of these proposed amendments

 in the Illinois

Register.

80—212

—3—

TITLE

35:

 ENVIRONMENTAL PROTECTION

SUBTITLE B:

 AIR POLLUTION

CHAPTbR

I:

 POLLUTION CONTROL BOARD

SUBCHAPTER

 EMISSION STANDARDS AND LIMITATIONS

FOR STATIONARY SOURCES

PART 211

DEFINITIONS AND GENERAL PROVISIONS

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.

“~roduction 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.

Volatile Organic Liquid”:

 Any liquid which contains

volatile organic material.

“Volatile Organic Material”:

 any orgar~4en~ater~a3~

 wh4eh

has

 a vapor

 presatire of ~

 kPa ~

 ps~a)~

greater

at 294~3—K~O-F+-

 For purposes of

5 ~

 Adn~?ode

~57442

 through ~S74447

 vo3~at~eergan~ei~eterta~

 means

any

organ~e n’teterta~ wh~eh has

vapor

pressure

~9~4

~Pe -~3~5ps~e~at 2.947~-K~

 For purposes of

5

 fl~ Adm~?ede ~

 through

 .?~?4y 2~5-445through

~-4S~

 2~5~O4through

 5~~9-,

~5~4G

through

5~345.~

5-48~ through

2~5~4O4~

~i5~46i

through

~d5-~464

and

5~6O~

through

2~~6Oa7vo~at~e orgen~e

~~teter~e~

~eens

any

ergan~e ~tater~a~

wh4eh

has

vapor

pressure

greater

than

kPe

~83~

ps~a~at

~94-~—K

~0~F~

80— 213

—4—

a)

 any organic material which participates

in

atmospheric photochemical reactions

or

is

measured

 by the applicable reference methods

specified

 under

 Part

 230, Appendix

A,

 unless

specifically exempted from this definition.

b)

 For purposes of

 this definition,

 the following

are not volatile organic materials:

Methane

Ethane

1,1,1, Trichioroethane

Methylene chloride

Trichlorofluoromethane

Dichlorodit luoromethane

Chiorodifluoromethane

 fiuoromethane

Trichlorotr ifluoroethane

Dichlorotetrafluoroethane

Chloropentafluoroethane

(Source:

 Amended

at

 Ill.

 Reg.

________,

 effective

___________

PART 215

ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS

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 obtained from Boublik,

T.,

V.

 Fried,

and

E.

 Hala,

 the Vapor Pressure of Pure Substances,

Elsevier Scientific Publishing Company,

 New York

(1973),

 Perry’s Chemical Engineer’s Handbook,

McGraw-Hill Book Company

 (1984), CRC Handbook of

Chemistry and Physics, Chemical Rubber

 Publishing

Company (l9~6-87),Lange’s Handbook

 of Chemistry,

John A.

 Dean, editor, McGraw-Hill Book Company

(1985),

or

 as determined by ASTM (American Society

of Testing and Materials

)

 Method D—2879-83.

2)

For

 a mixture, the actual

 vapor

 pressure shall

be

taken as either:

80—2 14

—5—

i)

 The lesser

of

 the sum of

 the actual vapor

pressure of each component

 or each volatile

organic material component,

 as determined

above, weighted

by

 its mole

 fraction,

or

ii)

If

 the vapor pressure of the volatile organic

material

 is specified,

 the sum of the actual

vapor pressure

 of each volatile organic

material component as determined above

weighted

 by its mole fraction.

(Source:

 Amended

at

 Ill. Reg.

_________,

 effective

_______________

Section 215.104

 Definitions

~Vo~at~ie Organ~eMater4e3~ P~nyorgan4e n’tater~a~wh4eh

has

 a vapor pressure of ~~24

 hPa .~-5ps~a~or greater

at 294~—Kf79~F~ For purposes of this defin~t~ien7the

fe~ew4n~are net vo~et~eorgen~emater~a~ts~

Methane

Ethene

~7~7~—trteh~ereethene

Methy~eneeh~er-ide

0hierod~fiaeremethane

~r~f~ueremethane

Tr4eh~eretr~fluereethene

?h~erepente~iuereethane

Fer purposes e~the foHewing Seet4ons7 ve3eti~e organie

~ateria~s

 are any erganie mater4a~shaving the

corresponding vapor pressures at 294~-K~

Seetions

 Vapor Pressure

—

2~.5~84

 0-9i~kPa

 ~ ~0019 psia~

~5~04

—

 2~S~99

 0~0~3

kPa

 ~00~9 peia~

~5~340

—

0-9~3

kPa

 ~ ~00i9 psia~

~5~40~

—

 2~~40B

 0~0~3kPa

 ~ ~99~9 psia~

~4~29

—

 ~5~-428

 070~3kPa

 ~ ~90~9 ps4e~

2~5-44i

—

 ~5-444

 ~0~4

kPa

 (.i-5

—

 2~5-45~

 9~0~kPa

 ~ ~00~9 ps4e+

~5746~

—

 ~5~464

 0~0i hPa

‘~

 ~0O~9 psia~

2~5~~0

—

 070i3 kPa

 ~00~9 psie~

~5~60i

—

 0~9~3hPa

 ~ ~00~9 psia~

(Source:

 Amended at

___

 Ill.

 Reg.

________,

 effective

_______________

80—215

—6—

Section 215.l~5

 incorporations

 by Reference

The following materials are incorporated

 by reference:

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

 97—66

 Federal Standard l4la, Method 4082.1

 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—051 Appendix A and

Appendix B

 (December 1978).

f)

 United States Environmental Protection Agency,

Washington,

 D.C.,

 EPA—450/2—78—04l, Chapter

7

 (1978).

~jj

 Boublik, T.,

 Fried,

 V., and Hala,

E.,

 The Vapor Pressure

of Pure Substances,

 Elsevier Scientific Publishing

Company, New york

 (1973).

h)

 Perry’s Chemical Engineer’s Handbook, McGraw—Hill Book

Company

 (1984).

1)

 CRC Handbook of Chemistry and Physics, Chemical Rubber

publishing Company

 (1986—87).

80—216

—7—

jj_

 Lange’s Handbook

 of Chemistry,

 John

A.

 Dean,

 editor,

McGraw-Hill Book Company

 (1985).

(Board Note:

 The incorporations by reference listed above

contain

 no later amendments

 or editions.)

(Source:

 Amended

at

 Ill. Reg.

 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

rea.ctors, distillation

 units,

dryers, storage

 tanks

for

volatile organic

 liquids, equipment for

 the transfer

of

volatile organic liquids,

 filters, crystallizers,

washers, laboratory hoods,

 coating operations,

 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

one

or

 more sources exceed 45.4 kg/day

 (100 lbs/day).

b)

 Sections 215.483 through 215.465

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).

c)

 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. Reg.

________,

 effective

___________

)

Section 215.481

 Control of Reactors, Distillation Units,

Crystallizers, Centrifuges and Vacuum Dryers

a)

 The owner

 on operator shall control all reactors,

distillation units,

 crystallizers, centrifuges and

80—217

—6—

vacuum dryers 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 (-l3~F) when condensing volatile organic

material

 of vapor pressure greater than 40.0 kPa

(5.8 psi)

 at 294.3

K

 (70CF);

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

 (70Z)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

);

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

 (70F).

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).

(Source:

 Added

at

 Ill.

 Reg.

_________,

 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

organic material from such emission sources by air

pollution control equipment 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

 (700F).

80—218

—9—

(Source:

 Amended

at

 Ill. Reg.

 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 storase tanks with capacities

equal

 to or greater than 7.57m

 (2,000 gallons)

 that

store volatile organic liquids with vapor pressures

greater than

 28.0 kPa

 (4.1 psi)

 at 294.3

K

 (700F);

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 (700F),unless

 a more effective

control system

is

 used.

(Source:

 Added

at

 Ill. Reg.

________,

 effective

_______________

Section 215.464

 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. Reg.

 effective

_______________

Section 215.485

 Leaks

The owner

 or operator

of

 a pharmaceutical manufacturing plant

shall repair

 any component from which

 a leak of volatile organic

liquid

can

 be observed.

 The repair

 shall

 be completed

 as soon as

practicable

 but no later

 than 15 days after

 the leak

 is found

unless

 the leaking component cannot

 be repaired until

 the process

unit is shut down, and the leaking component must then

be

repaired before

 the unit

 is restarted.

(Source:

 Added

at

 Ill.

 Reg.

_________,

 effective

_______________

Section 215.486

 Other Emission Sources

80—219

—10—

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 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.

 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.

 Reg.

________,

 effective

___________

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

80—220

—11—

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.

Each

monitor

shall

operate

all

times

while

the

associated control equipment

 is operating.

(Source:

 Added

at

 Ill.

 Reg.

________,

 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

 (effective date

 of rule) 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 December

31,

1987.

b)

 The owner

 and operator

 of any emission source subject to

this Subpart,

 the construction or modification of which

has not commenced prior

to

 (effective date of rule),

shall construct such source so that it will operate

in

compliance with this Subpart.

(Source:

 Added

at

 Ill.

 Reg.

 effective

____________

ORDERED

I,

 Dorothy

 M. Gum,

 Clerk of the Illinois Pollution Control

Board, hereby certify that the above Proposed Rule,

 First Notice

Order

was

adopted

the

day

1987,

vote

~‘°

Dorothy

 M. Gdnn,

 Clerk

Illinois Pollution Control Board

80—221