Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
224.20-100,
224.20-110,
224.20-120,
42 U.S.C.
7401 et seq., 7407, 7408, 7410
NECESSITY, FUNCTION, 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 new synthesized pharmaceutical product manufacturing
operations.
Section 1. Definitions. As
used in this administrative regulation, all terms not defined in this section
shall have the meaning given to them in
401 KAR
59:001.
(1) "Affected
facility" means operations involved in the manufacture of pharmaceutical
products by chemical synthesis, but does not include fermentation, extraction,
or formulation and packaging.
(2)
"Extraction" means the manufacture of botanical and biological products by the
extraction of organic chemicals from vegetative materials or animal
tissues.
(3) "Fermentation" means
the production and separation of medicinal chemicals such as antibiotics and
vitamins from microorganisms.
(4)
"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 accurate
amount.
(5) "Classification date"
means February 4, 1981.
(6) "kPa"
means kilopascals.
(7) "psi" means
pounds per square inch.
Section
2. Applicability.
(1) This
administrative regulation shall apply to:
(a)
Each affected facility commenced on or after the classification date defined in
Section 1 of this administrative regulation and located in a county or portion
of a county designated as nonattainment for ozone in
401 KAR
51:010, for any classification except marginal;
and
(b) Each affected facility
commenced on or after June 24, 1992 which is part of a major source located in
a county or portion of a county designated attainment or marginal nonattainment
for ozone in
401 KAR
51:010.
(2) Each affected facility commenced on or
after the classification date defined in Section 1 of this administrative
regulation but prior to June 24, 1992 which is part of a major source located
in a county or portion of a county designated attainment or marginally
nonattainment for ozone in
401 KAR
51:010 shall be exempt from this administrative
regulation except that control devices and procedures required at the time it
commenced shall continue to be operated and maintained.
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 requirements:
(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 temperatures 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.
1. Negative
twenty-five (-25) °C; forty (40) kPa (five and eighteenths (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)
lbs/day).
(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 (20)
°C.
(5) All in-process tanks
containing VOCs 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 is 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 while 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.
Section 4.
Compliance Timetable.
(1) Affected facilities
which were subject to this administrative regulation as in effect on February
4, 1981, shall have achieved final compliance upon start-up.
(2) The owner or operator of an affected
facility that, on or after June 24, 1992, becomes subject to this
administrative regulation for a reason other than construction, modification,
or reconstruction 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 emissions control equipment no later than seven (7) months
after the date the affected facility becomes subject to this administrative
regulation.
(d) On-site
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.
Section 5. 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 specified by the cabinet
shall be conducted to determine the efficiency of the control device.
Section 6. 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 control device:
(1) For carbon adsorbers, a monitoring device
connected to an alarm device, which indicates carbon bed
breakthrough;
(2) For condensers, a
temperature securing device located in the exit gas stream;
(3) For incinerators, temperature securing
devices located in the combustion chamber for thermal incinerators and in the
catalyst preheat chamber for catalytic incinerators; and
(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.
STATUTORY AUTHORITY:
KRS
224.10-100