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TITLE 30ENVIRONMENTAL QUALITY
PART 1TEXAS COMMISSION ON ENVIRONMENTAL QUALITY
CHAPTER 115CONTROL OF AIR POLLUTION FROM VOLATILE ORGANIC COMPOUNDS
SUBCHAPTER FMISCELLANEOUS INDUSTRIAL SOURCES
DIVISION 2PHARMACEUTICAL MANUFACTURING FACILITIES
RULE §115.532Control Requirements

(a) For the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston areas, the owner or operator of a synthesized pharmaceutical manufacturing facility shall provide the following specified controls.

  (1) Tanks.

    (A) All in-process tanks that contain volatile organic compounds (VOC) at any time shall be kept covered, except when production, sampling, maintenance, or inspection procedures require operator access.

    (B) All storage tanks that store VOC shall have pressure vacuum conservation vents installed which are set at plus or minus 0.8 inches of water (plus or minus 0.2 kPa), unless a more effective control system is used.

  (2) Centrifuges and filters. Centrifuges, rotary vacuum filters, and other filters having an exposed liquid surface which process liquids containing VOC shall be enclosed.

  (3) Leaks.

    (A) All liquid leaks containing VOC from a process unit or storage tank shall be repaired the first time the equipment is off-line long enough to complete the repair.

    (B) All liquid or gaseous leaks of VOC observed during loading operations shall be repaired immediately. Loading operations shall be discontinued until the leak is repaired.

  (4) Air dryers, production equipment exhaust systems, and loading facilities. Sources affected by §115.531(a) of this title (relating to Emission Specifications) shall be controlled by a system with a reduction efficiency of at least 90% of the uncontrolled emissions.

  (5) Pharmaceutical manufacturing facility. Any pharmaceutical manufacturing facility that becomes subject to the provisions of paragraphs (1) - (4) of this subsection by exceeding provisions of §115.537(a) of this title (relating to Exemptions) will remain subject to the provisions of this subsection, even if throughput or emissions later fall below exemption limits, unless and until emissions are reduced to no more than the controlled emissions level existing before implementation of the project by which throughput or emission rate was reduced to less than the applicable exemption limits in §115.537(a) of this title; and:

    (A) the project by which throughput or emission rate was reduced is authorized by any permit or permit amendment or standard permit or permit by rule required by Chapter 116 or Chapter 106 of this title (relating to Control of Air Pollution by Permit for New Construction or Modification; and Permits by Rule). If a permit by rule is available for the project, compliance with this subsection must be maintained for 30 days after the filing of documentation of compliance with that permit by rule; or

    (B) if authorization by permit, permit amendment, standard permit, or permit by rule is not required for the project, the owner/operator has given the executive director 30 days' notice of the project in writing.

(b) For Gregg, Nueces, and Victoria Counties, the owner or operator of a synthesized pharmaceutical manufacturing facility shall provide the following specified controls.

  (1) Tanks.

    (A) All in-process tanks that contain VOC at any time shall be kept covered, except when production, sampling, maintenance, or inspection procedures require operator access.

    (B) All storage tanks that store VOC shall have pressure vacuum conservation vents installed which are set at plus or minus 0.8 inches of water (plus or minus 0.2 kPa), unless a more effective control system is used.

  (2) Centrifuges and filters. Centrifuges, rotary vacuum filters, and other filters having an exposed liquid surface which process liquids containing VOC shall be enclosed.

  (3) Leaks.

    (A) All liquid leaks containing VOC from a process unit or storage tank shall be repaired the first time the equipment is off-line long enough to complete the repair.

    (B) All liquid or gaseous leaks of VOC observed during loading operations shall be repaired immediately. Loading operations shall be discontinued until the leak is repaired.

  (4) Air dryers, production equipment exhaust systems, and loading facilities. Sources affected by §115.531(b) of this title shall be controlled by a system with a reduction efficiency of at least 90% of the uncontrolled emissions.


Source Note: The provisions of this §115.532 adopted to be effective February 19, 1990, 15 TexReg 549; amended to be effective July 17, 1991, 16 TexReg 3729; amended to be effective August 1, 1992, 17 TexReg 4683; amended to be effective May 27, 1994, 19 TexReg 3703; amended to be effective May 22, 1997, 22 TexReg 4213; amended to be effective May 16, 2002, 27 TexReg 4113

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