State of California
AIR RESOURCES BOARD
State Building
Auditorium
107 South Broadway
Los Angeles, CA
August 28, 1980
10:00 a.m.
AGENDA
Page
80-16-1 Cogeneration Technology and Resource Recovery 001
Status Report.
80-16-2 Public Meeting to Consider Suggested Control 092
Measure for the Control of Organic Emissions
from Pharmaceutical and Cosmetics Manufacturing
Operations.
80-16-3 Other Business
a. Executive Session
Personnel
Litigation
b. Research Proposals
c. Delegations to Executive Officer
ITEM NO.: 80-16-2
Suggested Control Measure for the Control of Organic Emissions
from Pharmaceutical and Cosmetics Manufacturing Operations.
SUMMARY AND STATEMENT OF REASONS FOR SUGGESTED CONTROL MEASURE
The California Air Resources Board is considering approval of a
suggested control measure for the control of volatile organic
compound (VOC) emissions from pharmaceutical and cosmetics
manufacturing operations. If approved by the Board, the proposal
will be forwarded to appropriate Air Pollution Control Districts
(APCDs) for consideration and adoption into regulatory form to
the extent necessary to provide for attainment and maintenance of
state and national ambient air quality standards for
photochemical oxidant. Until formally adopted into the rules and
regulations of a district, the suggested measure is not an
enforceable regulation, no compliance from affected industries is
required.
The manufacture of pharmaceuticals and cosmetics is composed of
individual operations which include chemical reactions, product
separation, purification and drying. Many of these steps require
the use of VOCs as raw materials or solvents and, are sources of
VOC emissions to the atmosphere.
The resulting VOC emissions are involved in complex reactions in
the atmosphere which result in the formation of photochemcial
oxidants, including ozone. Pursuant to Clean air Act
requirements for attainment and maintenance of the ozone ambient
air quality standard, the staff of the South Coast Air Quality
Management District (SCAQMD), with the cooperation of the other
APCDs, ARB and EPA, has developed a suggested control measure for
the control of VOC emissions from pharmaceutical and cosmetics
manufacturing. Sources of background information used to develop
the proposed control measure and this staff report include:
information from the SCAQMD, including its staff report;
information from the EPA, including its Control Techniques
Guideline (CTG); and information from the Federal Register as
noted herein; information including emission data, from the
affected APCDs; information obtained from plant visits by the ARB
staff; and other reports cited in the aforementioned sources or
in this report. The staff report and these referenced documents
are available for public inspection at or may be obtained from
the Air Resources Board Public Information Office, 1102 Q Street,
Sacramento, 95814 on or after July 9, 1980.
Applicable emission control technology for the pharmaceutical and
cosmetics manufacture industry include but is not limited to
condensers, scrubbers, carbon adsorbers, and incinerators, and
for emissions resulting from storage and transfer of raw
materials vapor return lines, vent condensers, and pressure
tanks. These controls have been found by EPA, the ARB, the
SCAQMD, and many other air pollution control districts to be
reasonably available for this category of emission sources.
The approximate range of cost-effectiveness for control of this
source is estimated by the ARB staff to be $0.06-0.51 per pound
(based on a sample plant survey). Most of the sources in this
category are in the South Coast and the Bay Area Air Quality
Management Districts. It is estimated that emission reductions
up to 90 percent can be achieved through the implementation of
this measure.
The proposed measure would require the use of surface condensers
or equivalent controls for each vent from a reactor, distillation
operation, crystallizer, centrifuge, or vacuum dryer that emits
15 lb/day or more of VOC.
If surface condensers are used, the condenser outlet gas
temperatures must not exceed the following:
(I) -25øC when condensing VOC of vapor pressure greater
than 5.8 psi,
(ii) -15øC when condensing VOC of vapor pressure greater
than 2.9 psi,*
(iii) 0øC when condensing VOC of vapor pressure greater than
1.5 psi,*
(iv) 10øC when condensing VOC of vapor pressure greater than
1.0 psi,* and
(v) 25øC when condensing VOC of vapor pressure greater than
0.5 psi.*
The measure also would require a 90 percent emission reduction
for air dryers and production equipment exhaust systems that emit
330 lbs/day or more of VOC, or an emission reduction to 33
lbs/day for air dryers and production equipment exhaust systems
that emit less than 330 lbs/day.
The measure would also allow one liter of displaced vapor to be
released to the atmosphere for every ten liters transferred, or a
90 percent effective vapor balance system or equivalent on
truck/rail car delivery to all tanks greater than 2000 gallons
capacity which store VOC with a vapor pressure greater than 4.1
psi at 20øC. Where tanks are equipped with floating roofs, vapor
recovery, or equivalent systems this provision is not required.
Pressure/vacuum conservation vents set at + .03 psi for tanks
storing VOC would be required if the vapor pressure of the
organic solvent is greater than 1.5 psi at 20øC, unless a more
effective air pollution control device is used.
The measure also would require enclosure of centrifuges
containing VOC, rotary vacuum filters processing liquid
containing VOC, and any other filters having an exposed liquid
surface where the liquid contains VOC. This provision would
apply to liquid exerting a total VOC vapor pressure of 0.5 psi or
more at 20øC.
Covers would be required on all in-process tanks which should be
closed when possible.
Lastly, the measure would require repair of all leaks in which
liquid containing VOC could be observed.