401 KAR 61:150.
Existing synthesized pharmaceutical product manufacturing operations.
RELATES TO: KRS
224.20-100, 224.20-110, 224.20-120, 42 U.S.C. 7401 et seq., 7407, 7408, 7410
AND CONFORMITY: KRS 224.10-100 requires the Environmental and Public Protection
Cabinet to prescribe administrative regulations for the prevention, abatement,
and control of air pollution. 42 USC 7410 likewise requires the state to
implement standards for national primary and secondary ambient air quality.
This administrative regulation provides for the control of volatile organic
compound emissions from existing synthesized pharmaceutical product manufacturing
Definitions. As used in this administrative regulation, all terms not defined
in this section shall have the meaning given to them in 401 KAR 61:001.
facility" means operations involved in the manufacture of pharmaceutical
products by chemical synthesis, but does not include fermentation, extraction,
or formulation and packaging.
"Extraction" means the manufacture of botanical and biological
products by the extraction of organic chemicals from vegetative materials or
"Fermentation" means the production and separation of medicinal
chemicals such as antibiotics and vitamins from microorganisms.
"Formulation and packaging" means the formulation of bulk
pharmaceuticals into various dosage forms such as tablets, capsules, injectable
solutions, ointments, etc., that can be taken by the patient immediately and in
"Classification date" means February 4, 1981.
means pounds per square inch.
Applicability. This administrative regulation shall apply to each affected
facility commenced before the classification date defined in Section 1 of this
administrative regulation which is located in a county or portion of a county
which is designated ozone nonattainment, for any nonattainment classification
except marginal, under 401 KAR 51:010.
Section 3. Standard
for VOCs. The owner or operator of an affected facility to which this
administrative regulation applies shall install, maintain and operate the
control equipment and observe at all times the following operating
(1)(a) Each vent
from reactors, distillation operations, crystallizers, centrifuges, and vacuum
dryers that emit six and eight-tenths (6.8) kg/day (fifteen (15) lb/day) or
more of VOCs shall be equipped with surface condensers or other methods of
control which provide emission reductions equivalent to the use of surface
condensers which meet the requirements in paragraph (b) of this subsection.
(b) If surface
condensers are used, the condenser outlet gas temperature shall not exceed the
following temperatures (degrees Celsius) if condensing VOCs with the respective
minimum vapor pressures (kilopascals). All vapor pressures are measured to
twenty (20) degrees Celsius.
twenty-five (-25) °C; forty (40) kPa (five and eight-tenths (5.8) psi);
2. Negative fifteen
(-15) °C; twenty (20) kPa (two and nine-tenths (2.9) psi);
3. Zero °C; ten (10)
kPa (one and five-tenths (1.5) psi);
4. Ten (10) °C;
seven (7) kPa (one (1.0) psi); and
5. Twenty-five (25)
°C; three and five tenths (3.5) kPa (five-tenths (0.5) psi).
(2)(a) For air
dryers and production equipment exhaust systems that emit 150 kg/day (330
lbs/day) or more of VOCs, emissions shall be reduced ninety (90) percent.
(b) For air dryers
and production equipment exhaust systems that emit less than 150 kg/day (330
lbs/day), emissions shall be reduced to fifteen (15) kg/day (thirty-three (33)
(3)(a) For storage
tanks storing VOCs with a vapor pressure greater than twenty-eight (28) kPa
(four and one-tenth (4.1) psi) at twenty (20) °C, one (1) liter of displaced
vapor shall be allowed to be released to the atmosphere for every ten (10)
liters transferred (i.e., a ninety (90) percent effective vapor balance or
equivalent) on truck or rail car delivery to all tanks greater than 7,500
liters (2,000 gal) capacity unless the tanks are equipped with floating roofs,
vapor recovery systems, or their equivalent. This requirement does not apply to
transfer of VOCs from one (1) in-plant location to another.
(b) For tanks
storing VOCs with a vapor pressure greater than ten (10) kPa (one and
five-tenths (1.5) psi) at twenty (20) °C, the pressure or vacuum conservation
vents shall be set at plus or minus two-tenths (0.2) kPa, unless more effective
air pollution control is used.
(4) All centrifuges
containing VOCs, rotary vacuum filters processing liquid containing VOCs and
other filters having an exposed liquid surface if the liquid contains VOCs
shall be enclosed. This applies to liquids exerting a total VOCs vapor pressure
of three and five-tenths (3.5) kPa (five-tenths (0.5) psi) or more at twenty
(5) All in-process
tanks containing VOC at any time shall have covers which shall be closed except
for short periods when production, sampling, maintenance, or inspection
procedures require operator access.
(6) For liquids
containing VOCs, all leaks in which liquid can be observed to be running or
dripping from vessels and equipment (for example, pumps, valves, flanges) shall
be repaired within fifteen (15) days. A visual recheck shall be made after
repair. If the leak is still present or a new leak is created by the repair,
further maintenance shall be performed until the VOC emission drops below the
screening value (observed to be running or dripping). Leaks that cannot be
repaired within fifteen (15) days shall be repaired during the next scheduled
turnaround. If the cabinet requests it, the owner or operator shall demonstrate
to the cabinet's satisfaction why the repairs could not be completed within the
initial fifteen (15) day period. If the leak is unable to be brought into
compliance, a variance shall be requested and obtained on an individual basis.
Case-by-case alternatives approved by the cabinet, but not previously authorized
by the U.S. EPA, shall be submitted to the U.S. EPA as a SIP revision. Leak
detection or maintenance and repair procedures shall include maintaining a
survey log identifying when the leak occurred and reporting every ninety (90)
days those leaks not repaired after fifteen (15) days. The operator shall
retain the survey log for two (2) years after the inspection is completed.
Compliance Timetable. (1) Affected facilities which were subject to this
administrative regulation as in effect on February 4, 1981, shall have achieved
final compliance by December 31, 1982.
(2) The owner or
operator of an affected facility that becomes subject to this administrative
regulation on or after the effective date of this administrative regulation
shall be required to complete the following:
(a) Submit a final
control plan for achieving compliance with this administrative regulation no
later than three (3) months after the date the affected facility becomes
subject to this administrative regulation.
(b) Award the
control system contract no later than five (5) months after the date the
affected facility becomes subject to this administrative regulation.
(c) Initiate on-site
construction or installation of emission control equipment no later than seven
(7) months after the date the affected facility becomes subject to this
construction or installation of emission control equipment shall be completed
no later than eleven (11) months after the date the affected facility becomes
subject to this administrative regulation.
(e) Final compliance
shall be achieved no later than twelve (12) months after the date the affected
facility becomes subject to this administrative regulation.
(f) If an affected
facility becomes subject to this administrative regulation because it is
located in a county previously designated nonurban nonattainment or
redesignated in 401 KAR 51:010 after November 15, 1990, final compliance may be
extended to May 31, 1995, and the schedule in paragraphs (a) through (d) of
this subsection adjusted by the cabinet.
Compliance Procedures. Compliance shall be determined based upon an engineering
analysis by the cabinet of the control system design, control device
efficiency, control system capture efficiency, and other factors that could
influence the performance of the system. If requested by the cabinet,
performance tests as specified by the cabinet shall be conducted to determine
the efficiency of the control device.
Monitoring Requirements. If adsorbers, condensers, incinerators or scrubbers
are used to achieve compliance with Section 3 of this administrative
regulation, the following monitoring devices shall be an integral part of the
(1) For carbon
adsorbers, a monitoring device connected to an alarm device, which indicates
carbon bed breakthrough;
(2) For condensers,
a temperature sensing device located in the exit gas stream;
incinerators, temperature sensing devices located in the combustion chamber for
thermal incinerators and in the catalyst preheat chamber for catalytic
(4) For scrubbers,
flow meters for measuring flow rate of scrubbing medium or pressure drop
measuring devices indicating back pressure and pressure drop across the
scrubber. (7 Ky.R. 381; Am. 555; eff. 2-4-81; Am. 18 Ky.R. 2678; 3379; eff.
6-24-92; eff. 8-9-2007.)