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

Universal Citation: 30 TX Admin Code § 115.536

Current through Reg. 50, No. 13; March 28, 2025

(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.

(b) For Gregg, Nueces, and Victoria Counties, 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 VOC from process units affected by § 115.531(b)(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(b) of this title (relating to Emission Specifications) or § 115.532(b) 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) in Victoria County, 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(b) 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(b) 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, EPA, or local air pollution control agency.

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