Regulatory Text: 
Chapter 115.  Control of Air Pollution from Volatile Organic Compounds.

SUBCHAPTER F : MISCELLANEOUS INDUSTRIAL SOURCES

5F2 DIVISION 2: PHARMACEUTICAL MANUFACTURING FACILITIES
As approved by EPA February 27, 2008 (73 FR 10383) effective March 28, 2008 (TXd89)

Outline:
§115.531.  Emission Specifications. 5-41, TXc88C last
§115.532.  Control Requirements. 5-71, TXd89
§115.533.  Alternate Control Requirements. 5-71, TXd89
§115.534.  Inspection Requirements. 5-41, TXc88C last
§115.535.  Testing Requirements. 5-71, TXd89
§115.536.  Monitoring and Recordkeeping Requirements. 5-56, TXc105P last
§115.537.  Exemptions. 5-56, TXc105P last
§115.539.  Counties and Compliance Schedules. 5-71, TXd89


§115.531.  Emission Specifications. 5-41, TXc88C last
As adopted by TACB May 8, 1992 effective August 1, 1992, 1997 (5-41).
As approved by EPA March 7, 1995 (60 FR 12438) effective May 8, 1995 at 40 CFR 52.2270/52.2299(c)(88).  See the “Chapter 115 SIP Map” document above for the meaning of the left-justified codes before each paragraph.

88C   (a)  For the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston Areas as defined in §115.010 of this title (relating to Definitions), the owner or operator of a synthesized pharmaceutical manufacturing facility shall satisfy the following emission specifications:

77A        (1)  Reactors, Distillation Units, Crystallizers, Centrifuges, and Vacuum Dryers.  The emission of volatile organic compounds (VOC) from these sources shall be controlled by means of surface condensers from which the condenser outlet gas temperature must not exceed the following:

 

88C        (2)  Air Dryers and Exhaust Systems.  VOC emissions from all air dryers and production equipment exhaust systems shall be reduced to not more than 33 lb/day (15 kg/day) or controlled in accordance with §115.532(a)(4) of this title (relating to Control Requirements).

88C        (3)  Loading Facilities.  VOC emissions from truck or railcar deliveries to storage tanks at loading facilities shall be controlled in accordance with §115.532(a)(4) of this title (relating to Control Requirements).


88C   (b)  For Gregg, Nueces, and Victoria Counties, the owner or operator of a synthesized pharmaceutical manufacturing facility shall satisfy the following emission specifications:

88C        (1)  Reactors, Distillation Units, Crystallizers, Centrifuges, and Vacuum Dryers.  The emission of VOC from these sources shall be controlled by means of surface condensers from which the condenser outlet gas temperature must not exceed the following:

 

88C        (2)  Air Dryers and Exhaust Systems.  VOC emissions from all air dryers and production equipment exhaust systems shall be reduced to not more than 33 lb/day (15 kg/day) or controlled in accordance with §115.532(b)(4) of this title (relating to Control Requirements).

88C        (3)  Loading Facilities.  VOC emissions from truck or railcar deliveries to storage tanks at loading facilities shall be controlled in accordance with §115.532(b)(4) of this title (relating to Control Requirements).

********************* end 115.531 **********************


§115.532.  Control Requirements.
5-71:  As adopted by TNRCC April 26, 2002 effective May 16, 2002 (5-71).
Approved by EPA February 27, 2008 (73 FR 10383) effective March 28, 2008 (TXd89).

     (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.

Adopted April 26, 2002, Effective May 16, 2002 (5-71).
***end tx 115.532***5-71***EPA-R06-OAR-2005-TX-0015***TX021***TXd89***k36***


§115.533.  Alternate Control Requirements.
5-71:  As adopted by TNRCC April 26, 2002 effective May 16, 2002 (5-71).
Approved by EPA February 27, 2008 (73 FR 10383) effective March 28, 2008 (TXd89).

     Alternate methods of demonstrating and documenting continuous compliance with the applicable control requirements or exemption criteria in this division (relating to Pharmaceutical Manufacturing Facilities) may be approved by the executive director in accordance with §115.910 of this title (relating to Availability of Alternate Means of Control) if emission reductions are demonstrated to be substantially equivalent.

Adopted April 26, 2002, Effective May 16, 2002 (5-71).
***end tx 115.533***5-71***EPA-R06-OAR-2005-TX-0015***TX021***TXd89***k36***


§115.534.  Inspection Requirements. 5-41, TXc88C last
As adopted by TACB May 8, 1992 effective August 1, 1992, 1997 (5-41).
As approved by EPA March 7, 1995 (60 FR 12438) effective May 8, 1995 at 40 CFR 52.2270/52.2299(c)(88).  See the “Chapter 115 SIP Map” document above for the meaning of the left-justified codes before each paragraph.

88C   (a)  For all affected persons in Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston Areas, the following inspection requirements shall apply.

77A        (1)  Inspection for visible liquid leaks, visible fumes, or significant odors resulting from the transfer of volatile organic compounds (VOC) from trucks or railcars to storage tanks at loading facilities shall be conducted by the owner or operator of any pharmaceutical manufacturing facility.

77A        (2)  VOC loading or unloading through the affected transfer lines shall be discontinued immediately when a leak is observed and shall not be resumed until the observed leak is repaired.

88C   (b)  For all affected persons in Gregg, Nueces, and Victoria Counties, the following inspection requirements shall apply.

88C        (1)  Inspection for visible liquid leaks, visible fumes, or significant odors resulting from the transfer of volatile organic compounds (VOC) from trucks or railcars to storage tanks at loading facilities shall be conducted by the owner or operator of any pharmaceutical manufacturing facility.

88C        (2)  VOC loading or unloading through the affected transfer lines shall be discontinued immediately when a leak is observed and shall not be resumed until the observed leak is repaired.

*********************** end 115.534 **********************


§115.535.  Testing Requirements.
5-71:  As adopted by TNRCC April 26, 2002 effective May 16, 2002 (5-71).
Approved by EPA February 27, 2008 (73 FR 10383) effective March 28, 2008 (TXd89).

     (a)  For the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston areas, compliance with this division (relating to Pharmaceutical Manufacturing Facilities) shall be determined by applying the following test methods, as appropriate:

          (1)  Test Methods 1-4 (40 Code of Federal Regulations (CFR) 60, Appendix A) for determining flow rate, as necessary;

          (2)  Test Method 18 (40 CFR 60, Appendix A) for determining gaseous organic compound emissions by gas chromatography;

          (3)  Test Method 25 (40 CFR 60, Appendix A) for determining total gaseous nonmethane organic emissions as carbon;

          (4)  Test Methods 25A or 25B (40 CFR 60, Appendix A) for determining total gaseous organic concentrations using flame ionization or nondispersive infrared analysis;

          (5)  determination of true vapor pressure using American Society of Testing and Materials (ASTM) Test Method D323-82 for the measurement of Reid vapor pressure, adjusted for actual storage temperature in accordance with API Publication 2517, Third Edition, 1989; or

          (6)  minor modifications to these test methods approved by the executive director.

     (b)  For Gregg, Nueces, and Victoria Counties, compliance with this division shall be determined by applying the following test methods, as appropriate:

          (1)  Test Methods 1-4 (40 CFR 60, Appendix A) for determining flow rate, as necessary;

          (2)  Test Method 18 (40 CFR 60, Appendix A) for determining gaseous organic compound emissions by gas chromatography;

          (3)  Test Method 25 (40 CFR 60, Appendix A) for determining total gaseous nonmethane organic emissions as carbon;

          (4)  Test Methods 25A or 25B (40 CFR 60, Appendix A) for determining total gaseous organic concentrations using flame ionization or nondispersive infrared analysis;

          (5)  determination of true vapor pressure using ASTM Test Method D323-82 for the measurement of Reid vapor pressure, adjusted for actual storage temperature in accordance with API Publication 2517, Third Edition, 1989; or

          (6)  minor modifications to these test methods approved by the executive director.

Adopted April 26, 2002, Effective May 16, 2002 (5-71).
***end tx 115.535***5-71***EPA-R06-OAR-2005-TX-0015***TX021***TXd89***k36***


§115.536.  Monitoring and Recordkeeping Requirements. 5-56, TXc105P last
As adopted by TNRCC April 30, 1997 effective May 22, 1997 (5-56).
As approved by EPA January 26, 1999 (64 FR 03841) effective March 29, 1999 at 40 CFR 52.2270/52.2299(c)(105).  See the “Chapter 115 SIP Map” document above for the meaning of the left-justified codes before each paragraph.

88C   (a)  For the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston Areas, the following recordkeeping requirements shall apply.

88F        (1)  The owner or operator of any pharmaceutical manufacturing facility which utilizes a surface condenser to control emissions of volatile organic compounds (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.

88F        (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 or §115.532(a) of this title (relating to Control Requirements) shall:

88F             (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:

77A                  (i)  the exhaust gas temperature of direct-flame incinerators and/or the gas temperature immediately upstream and downstream of any catalyst bed,

88F                  (ii)  the exhaust gas VOC concentration of any carbon adsorption system to determine if breakthrough has occurred,

77C                  (iii)  the total amount of VOC recovered by carbon adsorption or other solvent recovery systems during a calendar month, or

77C                  (iv)  the daily emission rate of VOC from the control device;

77A             (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.

88C        (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:

77A             (A)  the vapor pressure of materials transferred at loading facilities, stored in tanks, or processed in centrifuges and filters; and

77A             (B)  the daily emissions rate of VOC.

88C        (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), and

105P       (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.

88C   (b)  For Gregg, Nueces, and Victoria Counties, the following recordkeeping requirements shall apply.

88F        (1)  The owner or operator of any pharmaceutical manufacturing facility which utilizes a surface condenser to control emissions of volatile organic compounds (VOC) from process units affected by §115.531(b)(1) of this title shall install and maintain monitors to continuously measure and record the outlet gas temperature to ensure proper functioning in accordance with design specifications.

88F        (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 or §115.532(b) of this title shall:

88F             (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:

88C                  (i)  the exhaust gas temperature of direct-flame incinerators and/or the gas temperature immediately upstream and downstream of any catalyst bed,

88F                  (ii)  in Victoria County, the exhaust gas VOC concentration of any carbon adsorption system to determine if breakthrough has occurred,

88F                  (iii)  the total amount of VOC recovered by carbon adsorption or other solvent recovery systems during a calendar month, or

88F                  (iv)  the daily emission rate of VOC from the control device;

88C             (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.

88C        (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:

88C             (A)  the vapor pressure of materials transferred at loading facilities, stored in tanks, or processed in centrifuges and filters; and

88C             (B)  the daily emissions rate of VOC.

88C        (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), and

105P       (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.

********************** end 115.536 ***********************


§115.537.  Exemptions. 5-56, TXc105P last
As adopted by TNRCC April 30, 1997 effective May 22, 1997 (5-56).
As approved by EPA January 26, 1999 (64 FR 03841) effective March 29, 1999 at 40 CFR 52.2270/52.2299(c)(105).  See the “Chapter 115 SIP Map” document above for the meaning of the left-justified codes before each paragraph.

88C   (a)  For the Beaumont/Port Arthur, Dallas/Fort Worth, El Paso, and Houston/Galveston Areas, the following exemptions shall apply.

88C        (1)  Storage tanks at loading facilities with capacities less than or equal to 2,000 gallons (7,571 liters) are exempt from the requirements of §115.531(a)(3) of this title (relating to Emission Specifications).

88C        (2)  Storage tanks at loading facilities that store volatile organic compounds (VOC) with vapor pressures less than or equal to 4.1 psia (28 kPa) at 68 degrees F (20 degrees C) are exempt from the requirements of §115.531(a)(3) of this title (relating to Emission Specifications).

88C        (3)  Storage tanks containing VOC with vapor pressures less than or equal to 1.5 psia (10.3 kPa) at 68 degrees F (20 degrees C) are exempt from the requirements of §115.532(a)(1)(B) of this title (relating to Control Requirements).

88C        (4)  Centrifuges and filters which process liquids containing VOC with vapor pressures less than 0.5 psia (3.4 kPa) at 68 degrees F (20 degrees C) are exempt from the requirements of §115.532(a)(2) of this title (relating to Control Requirements).

105P        (5) Any individual unit which, when uncontrolled, will emit a combined weight of VOC less than 15 pounds (6.8 kg) in any continuous 24-hour period is exempt from the provisions of §115.531(a) and §115.532(a) of this title.

105P  (b)  For Gregg, Nueces, and Victoria counties, the following exemptions shall apply.

88C        (1)  Storage tanks at loading facilities with capacities less than or equal to 2,000 gallons (7,571 liters) are exempt from the requirements of §115.531(b)(3) of this title (relating to Emission Specifications).

88C        (2)  Storage tanks at loading facilities that store volatile organic compounds (VOC) with vapor pressures less than or equal to 4.1 psia (28 kPa) at 68 degrees F (20 degrees C) are exempt from the requirements of §115.531(b)(3) of this title (relating to Emission Specifications).

88C        (3)  Storage tanks containing VOC with vapor pressures less than or equal to 1.5 psia (10.3 kPa) at 68 degrees F (20 degrees C) are exempt from the requirements of §115.532(b)(1)(B) of this title (relating to Control Requirements).

88C        (4)  Centrifuges and filters which process liquids containing VOC with vapor pressures less than 0.5 psia (3.4 kPa) at 68 degrees F (20 degrees C) are exempt from the requirements of §115.532(b)(2) of this title (relating to Control Requirements).

88C        (5)  Any facility which, when uncontrolled, will emit a combined weight of VOC less than 550 pounds (249.5 kg) in any continuous 24-hour period is exempt from the provisions of §115.531(b) of this title (relating to Emission Specifications) and §115.532(b) of this title (relating to Control Requirements).

******************* end 115.537 ************************


§115.539.  Counties and Compliance Schedules.
5-71:  As adopted by TNRCC April 26, 2002 effective May 16, 2002 (5-71).
Approved by EPA February 27, 2008 (73 FR 10383) effective March 28, 2008 (TXd89).

     All affected persons in Brazoria, Chambers, Collin, Dallas, Denton, El Paso, Fort Bend, Galveston, Gregg, Hardin, Harris, Jefferson, Liberty, Montgomery, Nueces, Orange, Tarrant, Victoria, and Waller Counties shall continue to comply with this division (relating to Pharmaceutical Manufacturing Facilities) as required by §115.930 of this title (relating to Compliance Dates).

Adopted April 26, 2002, Effective May 16, 2002 (5-71).
***end tx 115.539***5-71***EPA-R06-OAR-2005-TX-0015***TX021***TXd89***k36***
**************end texas chapter 115 subchapter f division 2***TXd89***k36***