401 KAR 61:150. Existing synthesized pharmaceutical product manufacturing operations

Link to law: http://www.lrc.ky.gov/kar/401/061/150.htm
Published: 2015

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      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

      STATUTORY AUTHORITY:

KRS 224.10-100

      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 existing 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 61:001.

      (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. 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

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 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.

      1. Negative

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)

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 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.

 

      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 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

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 as 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 sensing device located in the exit gas stream;

      (3) For

incinerators, temperature sensing 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. (7 Ky.R. 381; Am. 555; eff. 2-4-81; Am. 18 Ky.R. 2678; 3379; eff.

6-24-92; eff. 8-9-2007.)