Texas Administrative Code › Title 30 - ENVIRONMENTAL QUALITY › Part 1 - TEXAS COMMISSION ON ENVIRONMENTAL QUALITY › Chapter 115 - CONTROL OF AIR POLLUTION FROM VOLATILE ORGANIC › Subchapter F - MISCELLANEOUS INDUSTRIAL SOURCES › Division 2 - PHARMACEUTICAL MANUFACTURING FACILITIES › Section 115.536 - Monitoring and Recordkeeping Requirements

Current through Reg. 49, No. 28; July 12, 2024
(a) For the Beaumont/Port Arthur, Dallas/Fort
					 Worth, El Paso, and Houston/Galveston areas, the following recordkeeping
					 requirements shall apply.
(1) The owner or
					 operator of any pharmaceutical manufacturing facility which utilizes a surface
					 condenser to control emissions of volatile organic compound (VOC) from process
					 units affected by §
												115.531(a)(1)
					 of this title (relating to Emission Specifications) shall install and maintain
					 monitors to continuously measure and record the outlet gas temperature to
					 ensure proper functioning in accordance with design specifications.
(2) The owner or operator of any
					 pharmaceutical manufacturing facility which utilizes a vapor recovery system to
					 satisfy the requirements of §
												115.531(a)
					 of this title (relating to Emission Specifications) or §
												115.532(a)
					 of this title (relating to Control Requirements) shall:
(A) install and maintain monitors to
					 continuously measure and record operational parameters of all required control
					 devices as necessary to ensure the proper functioning of those devices in
					 accordance with design specifications, including:
(i) the exhaust gas temperature of
					 direct-flame incinerators and/or the gas temperature immediately upstream and
					 downstream of any catalyst bed;
(ii) the exhaust gas VOC concentration of any
					 carbon adsorption system, as defined in §
														115.10 of
					 this title (relating to Definitions), to determine if breakthrough has
					 occurred;
(iii) the total amount of
					 VOC recovered by carbon adsorption or other solvent recovery systems during a
					 calendar month; or
(iv) the daily
					 emission rate of VOC from the control device;
(B) maintain a record of the dates and
					 reasons for any maintenance and repair of the required control devices and the
					 estimated quantity and duration of VOC emissions during such
					 activities.
(3) The
					 owner or operator of any pharmaceutical manufacturing facility which is
					 exempted from the requirements in accordance with the provisions of §
												115.537(a)
					 of this title (relating to Exemptions) shall maintain a record of the following
					 information, as appropriate:
(A) the vapor
					 pressure of materials transferred at loading facilities, stored in tanks, or
					 processed in centrifuges and filters; and
(B) the daily emissions rate of
					 VOC.
(4) The owner or
					 operator of any affected pharmaceutical manufacturing facility shall maintain
					 records of any testing conducted at an affected facility in accordance with the
					 provisions specified in §
												115.535(a)
					 of this title (relating to Testing Requirements).
(5) The owner or operator of any affected
					 pharmaceutical manufacturing facility shall maintain all records at the
					 affected facility for at least two years and make such records available upon
					 request to representatives of the executive director, United States
					 Environmental Protection Agency (EPA), or local air pollution control
					 agency.