Form OP-UA34 (TCEQ-10291) "Pharmaceutical Manufacturing Facility Attributes" - Texas

What Is Form OP-UA34 (TCEQ-10291)?

This is a legal form that was released by the Texas Commission on Environmental Quality - a government authority operating within Texas. As of today, no separate filing guidelines for the form are provided by the issuing department.

Form Details:

  • Released on November 1, 2020;
  • The latest edition provided by the Texas Commission on Environmental Quality;
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Texas Commission on Environmental Quality
Form OP-UA34 - Instructions
Pharmaceutical Manufacturing Facility Attributes
General:
This form is used to provide a description and data pertaining to all pharmaceutical manufacturing facilities with
potentially applicable requirements associated with a particular regulated entity number and application. Each table
number, along with the possibility of a corresponding letter (i.e., Table 1a, Table 1b), corresponds to a certain state or
federal rule. If the rule on the table is not potentially applicable to a pharmaceutical manufacturing facility, then it should
be left blank and need not be submitted with the application. If the codes entered by the applicant show negative
applicability to the rule or sections of that rule represented on the table, then the applicant does not have to complete the
remainder of the table(s) that correspond to the rule. Further instruction as to which questions should be answered and
which questions should not be answered are located in the “Specific” section of the instruction text. The following is
included in this form.
Table 1a
-
1d:
Title 30 Texas Administrative Code Chapter 115 (30 TAC Chapter 115), Subchapter F,
Division 2: Pharmaceutical Manufacturing Facilities
The Texas Commission on Environmental Quality (TCEQ) regulated entity number (RNXXXXXXX) and the application
area name (from Form OP-1) must appear in the header of each page for purpose of identification for the initial submittal.
The date of the initial form submittal must also be included and should be consistent throughout the application
(MM/DD/YYYY). Leave the permit number blank for the initial form submittal. If this form is included as part of the
permit revision process, enter the permit number assigned by the TCEQ, the area name (from Form OP-1), the date of the
revision submittal, and the regulated entity number.
Unit attribute questions that do not require a response from all applicants are preceded by qualification criteria in the
instructions. If the unit does not meet the qualification criteria, a response to the question is not required. Anytime a
response is not required based on the qualification criteria, leave the space on the form blank.
Notwithstanding any qualification criteria in the form instructions or information provided in other TCEQ
guidance, the applicant may leave an attribute question blank (or indicate “N/A” for “Not Applicable”) if the
attribute is not needed for the applicable requirement determinations of a regulation for a unit.
In some situations, the applicant has the option of selecting alternate requirements, limitations, and/or practices for a unit.
Note that these alternate requirements, limitations, and/or practices must have the required approval from the TCEQ
Executive Director and/or the U.S. Environmental Protection Agency (EPA) Administrator before the federal operating
permit application is submitted.
The Texas Commission on Environmental Quality (TCEQ) requires that a Core Data Form be submitted on all incoming
registrations unless all of the following are met: the Regulated Entity and Customer Reference Numbers have been issued
by the TCEQ and no core data information has changed. The Central Registry, a common record area of the TCEQ,
maintains information about TCEQ customers and regulated activities, such as company names, addresses, and telephone
numbers. This information is commonly referred to as “core data.” The Central Registry provides the regulated
community with a central access point within the agency to check core data and make changes when necessary. When
core data about a facility is moved to the Central Registry, two new identification numbers are assigned: the Customer
Reference (CN) number and the Regulated Entity (RN) number. The Core Data Form is required if facility records are not
yet part of the Central Registry or if core data for a facility has changed. If this is the initial registration, permit, or license
for a facility site, then the Core Data Form must be completed and submitted with application or registration forms. If
amending, modifying, or otherwise updating an existing record for a facility site, the Core Data Form is not required,
unless any core data information has changed. To review additional information regarding the Central Registry, go to the
TCEQ website at www.tceq.texas.gov/permitting/central_registry/index.html.
TCEQ - 10291 (v16, Revised 11/20) OP-UA34
This form is for use by sources subject to air quality permit
requirements and may be revised periodically. (Title V Release 09/20)
Page 1 of 6
Texas Commission on Environmental Quality
Form OP-UA34 - Instructions
Pharmaceutical Manufacturing Facility Attributes
General:
This form is used to provide a description and data pertaining to all pharmaceutical manufacturing facilities with
potentially applicable requirements associated with a particular regulated entity number and application. Each table
number, along with the possibility of a corresponding letter (i.e., Table 1a, Table 1b), corresponds to a certain state or
federal rule. If the rule on the table is not potentially applicable to a pharmaceutical manufacturing facility, then it should
be left blank and need not be submitted with the application. If the codes entered by the applicant show negative
applicability to the rule or sections of that rule represented on the table, then the applicant does not have to complete the
remainder of the table(s) that correspond to the rule. Further instruction as to which questions should be answered and
which questions should not be answered are located in the “Specific” section of the instruction text. The following is
included in this form.
Table 1a
-
1d:
Title 30 Texas Administrative Code Chapter 115 (30 TAC Chapter 115), Subchapter F,
Division 2: Pharmaceutical Manufacturing Facilities
The Texas Commission on Environmental Quality (TCEQ) regulated entity number (RNXXXXXXX) and the application
area name (from Form OP-1) must appear in the header of each page for purpose of identification for the initial submittal.
The date of the initial form submittal must also be included and should be consistent throughout the application
(MM/DD/YYYY). Leave the permit number blank for the initial form submittal. If this form is included as part of the
permit revision process, enter the permit number assigned by the TCEQ, the area name (from Form OP-1), the date of the
revision submittal, and the regulated entity number.
Unit attribute questions that do not require a response from all applicants are preceded by qualification criteria in the
instructions. If the unit does not meet the qualification criteria, a response to the question is not required. Anytime a
response is not required based on the qualification criteria, leave the space on the form blank.
Notwithstanding any qualification criteria in the form instructions or information provided in other TCEQ
guidance, the applicant may leave an attribute question blank (or indicate “N/A” for “Not Applicable”) if the
attribute is not needed for the applicable requirement determinations of a regulation for a unit.
In some situations, the applicant has the option of selecting alternate requirements, limitations, and/or practices for a unit.
Note that these alternate requirements, limitations, and/or practices must have the required approval from the TCEQ
Executive Director and/or the U.S. Environmental Protection Agency (EPA) Administrator before the federal operating
permit application is submitted.
The Texas Commission on Environmental Quality (TCEQ) requires that a Core Data Form be submitted on all incoming
registrations unless all of the following are met: the Regulated Entity and Customer Reference Numbers have been issued
by the TCEQ and no core data information has changed. The Central Registry, a common record area of the TCEQ,
maintains information about TCEQ customers and regulated activities, such as company names, addresses, and telephone
numbers. This information is commonly referred to as “core data.” The Central Registry provides the regulated
community with a central access point within the agency to check core data and make changes when necessary. When
core data about a facility is moved to the Central Registry, two new identification numbers are assigned: the Customer
Reference (CN) number and the Regulated Entity (RN) number. The Core Data Form is required if facility records are not
yet part of the Central Registry or if core data for a facility has changed. If this is the initial registration, permit, or license
for a facility site, then the Core Data Form must be completed and submitted with application or registration forms. If
amending, modifying, or otherwise updating an existing record for a facility site, the Core Data Form is not required,
unless any core data information has changed. To review additional information regarding the Central Registry, go to the
TCEQ website at www.tceq.texas.gov/permitting/central_registry/index.html.
TCEQ - 10291 (v16, Revised 11/20) OP-UA34
This form is for use by sources subject to air quality permit
requirements and may be revised periodically. (Title V Release 09/20)
Page 1 of 6
OP-UA34 Instructions
Specific:
Table
1a:
Title 30 Texas Administrative Code Chapter 115 (30 TAC Chapter 115), Subchapter F,
Division 2: Pharmaceutical Manufacturing Facilities
Complete Tables 1a - 1d only for synthesized pharmaceutical manufacturing facilities located in Brazoria, Chambers,
Collin, Dallas, Denton, Ellis, El Paso, Fort Bend, Galveston, Gregg, Hardin, Harris, Jefferson, Johnson, Kaufman,
Liberty, Montgomery, Nueces, Orange, Parker, Rockwall, Tarrant, Waller, or Victoria County.
Process ID No.:
Enter the identification number (ID No.) for the pharmaceutical manufacturing process (facility) (maximum 10 characters)
as listed on Form OP-SUM (Individual Unit Summary).
SOP Index No.:
Site operating permit (SOP) applicants should indicate the SOP index number for the process (maximum 15 characters
consisting of numeric, alphanumeric characters, and/or dashes prefixed by a code for the applicable regulation
[i.e., 60KB-XXXX]). For additional information relating to SOP index numbers, please go to the TCEQ website at
www.tceq.texas.gov/assets/public/permitting/air/Guidance/Title_V/additional_fop_guidance.pdf.
Alternate Control Requirement (ACR):
Enter “YES” if using an alternate method for demonstrating and documenting continuous compliance with applicable
control requirements or exemption criteria and demonstrating substantially equivalent reduction efficiencies, which have
been approved by the TCEQ Executive Director. Otherwise, enter “NO.”
ACR ID No.:
If an alternate control requirement (ACR) has been approved, enter the corresponding ACR unique identifier for each unit.
If the unique identifier is unavailable, then enter the date of the ACR approval letter in the table column. The unique
identifier and/or the date of the approval letter are contained in the Compliance File under the appropriate account
number. Otherwise, leave this column blank.
Continue only if “Alternate Control Requirement” is “NO.”
Complete “Unit Uncontrolled VOC Emissions” only if the pharmaceutical manufacturing facility is located
in Gregg, Nueces, or Victoria County.
Uncontrolled VOC Emissions:
Enter “YES” if the facility emits an uncontrolled combined weight of volatile organic compound (VOC) less than
550 pounds (249.5 kilograms) in any continuous 24-hour period. Otherwise, enter “NO.” (If not claiming exemption
30 TAC § 115.137(b)(5), enter “NO” or leave this column blank.)
Do not continue if “Uncontrolled VOC Emissions” is “YES.”
Complete “Combined Weight of Uncontrolled VOC Emissions” only if the pharmaceutical manufacturing
facility is located in Brazoria, Chambers, Collin, Dallas, Denton, Ellis, El Paso, Fort Bend, Galveston,
Hardin, Harris, Jefferson, Johnson, Kaufman, Liberty, Montgomery, Orange, Parker, Rockwall, Tarrant, or
.
Waller County
Combined Weight of Uncontrolled VOC Emissions:
Enter “YES” if any unit emits an uncontrolled combined weight of VOC less than 15 pounds (6.8 kilograms) in any
continuous 24-hour period. Otherwise, enter “NO.” (If not claiming exemption 30 TAC § 115.137(a)(5), enter “NO” or
leave this column blank.)
Reactors:
Enter “YES” if the process includes reactors, distillation units, crystallizers, centrifuges or vacuum dryers. Otherwise,
enter “NO.”
TCEQ - 10291 (v16, Revised 11/20) OP-UA34
This form is for use by sources subject to air quality permit
requirements and may be revised periodically. (Title V Release 09/20)
Page 2 of 6
OP-UA34 Instructions
Complete “Centrifuge VOC Vapor Pressure Exemption” and “Other Centrifuges” only if “Reactors” is
“YES.”
Centrifuge VOC Vapor Pressure Exemption:
Enter “YES” if the process contains centrifuges which process liquids containing VOC with vapor pressure less than
0.5 psia (3.4 kilopascals) at 68°F (20°C). Otherwise, enter “NO.” (If not claiming exemption 30 TAC § 115.137(a)(4) or
30 TAC § 115.137(b)(4), enter “NO” or leave this column blank.)
Other Centrifuges:
Enter “YES” if the process contains centrifuges which process liquids containing VOC with vapor pressure greater than or
equal to 0.5 psia (3.4 kilopascals) at 68°F (20°C). Otherwise, enter “NO.”
Vapor Recovery System:
Select one of the following options if the reactors, distillation units, crystallizers, centrifuges or vacuum dryers utilize a
vapor recovery system to comply with an emission specification in 30 TAC § 115.531 or a control requirement in 30 TAC
§ 115.532. If a vapor recovery system is not utilized, enter “NONE.”
Code
Description
INC
Vapor recovery system with a direct-flame incinerator
SOLV
Vapor recovery system with a solvent recovery system other than a carbon adsorption system
CADS
Vapor recovery system with a carbon adsorption system
OTHER
Other control device
NONE
A vapor recovery system is not utilized to comply with an emission specification or control
requirement
Control Device ID No.:
If applicable, enter the identification number (ID No.) for the control device to which emissions are routed. This number
should be consistent with the control device identification number (maximum 10 characters) as listed on Form OP-SUM
(Individual Unit Summary).
Table
1b:
Title 30 Texas Administrative Code Chapter 115 (30 TAC Chapter 115), Subchapter F,
Division 2: Pharmaceutical Manufacturing Facilities
Process ID No.:
Enter the identification number (ID No.) for the pharmaceutical manufacturing process (maximum 10 characters) as listed
on Form OP-SUM (Individual Unit Summary).
SOP Index No.:
Site operating permit (SOP) applicants should indicate the SOP index number for the process (maximum 15 characters
consisting of numeric, alphanumeric characters, and/or dashes prefixed by a code for the applicable regulation
[i.e., 60KB-XXXX]). For additional information relating to SOP index numbers, please go to the TCEQ website at
www.tceq.texas.gov/assets/public/permitting/air/Guidance/Title_V/additional_fop_guidance.pdf.
Air Dryers:
Enter “YES” if the process includes air dryers or production equipment exhaust systems. Otherwise, enter “NO.”
Emissions ≤ 33 Lbs/Day:
Enter “YES” if VOC emissions from all air dryers and production equipment exhaust systems are reduced to less than or
equal to 33 pounds per day (15 kilograms per day). Otherwise, enter “NO.”
TCEQ - 10291 (v16, Revised 11/20) OP-UA34
This form is for use by sources subject to air quality permit
requirements and may be revised periodically. (Title V Release 09/20)
Page 3 of 6
OP-UA34 Instructions
Vapor Recovery System:
Select one of the following options if the air dryers utilize a vapor recovery system to comply with an emission
specification in 30 TAC § 115.531 or a control requirement in 30 TAC § 115.532. If a vapor recovery system is not
utilized, enter “NONE.”
Code
Description
INC
Vapor recovery system with a direct-flame incinerator
SOLV
Vapor recovery system with a solvent recovery system other than a carbon adsorption system
CADS
Vapor recovery system with a carbon adsorption system
OTHER
Other control device
NONE
A vapor recovery system is not utilized to comply with an emission specification or control
requirement
Control Device ID No.:
If applicable, enter the identification number (ID No.) for the control device to which emissions are routed. This number
should be consistent with the control device identification number (maximum 10 characters) as listed on Form OP-SUM
(Individual Unit Summary).
Storage Tanks at Loading Facility:
Enter “YES” if the process produces VOC emissions from truck or railcar deliveries to storage tanks at loading facilities.
Otherwise, enter “NO.”
Vapor Recovery System:
Select one of the following options if the storage tanks at a loading facility utilize a vapor recovery system to comply with
an emission specification in 30 TAC § 115.531 or a control requirement in 30 TAC § 115.532. If a vapor recovery system
is not utilized, enter “NONE.”
Code
Description
INC
Vapor recovery system with a direct-flame incinerator
SOLV
Vapor recovery system with a solvent recovery system other than a carbon adsorption system
CADS
Vapor recovery system with a carbon adsorption system
OTHER
Other control device
NONE
A vapor recovery system is not utilized to comply with an emission specification or control
requirement
Control Device ID No.:
If applicable, enter the identification number (ID No.) for the control device to which emissions are routed. This number
should be consistent with the control device identification number (maximum 10 characters) as listed on Form OP-SUM
(Individual Unit Summary).
Table
1c:
Title 30 Texas Administrative Code Chapter 115 (30 TAC Chapter 115), Subchapter F,
Division 2: Pharmaceutical Manufacturing Facilities
Process ID No.:
Enter the identification number (ID No.) for the pharmaceutical manufacturing process (maximum 10 characters) as listed
on Form OP-SUM (Individual Unit Summary).
SOP Index No.:
Site operating permit (SOP) applicants should indicate the SOP index number for the process (maximum 15 characters
consisting of numeric, alphanumeric characters, and/or dashes prefixed by a code for the applicable regulation
[i.e., 60KB-XXXX]). For additional information relating to SOP index numbers, please go to the TCEQ website at
www.tceq.texas.gov/assets/public/permitting/air/Guidance/Title_V/additional_fop_guidance.pdf.
Complete “Loading Facility Storage Tank Capacity Exemption” and “Loading Facility Storage Tank VOC
TCEQ - 10291 (v16, Revised 11/20) OP-UA34
This form is for use by sources subject to air quality permit
requirements and may be revised periodically. (Title V Release 09/20)
Page 4 of 6
OP-UA34 Instructions
Vapor Pressure Exemption” only if “Storage Tank at Loading Facility” is “YES.”
Loading Facility Storage Tank Capacity Exemption:
Enter “YES” if the process contains storage tanks at loading facilities with capacities less than or equal to 2,000 gallons
(7,571 liters). Otherwise, enter “NO.” (If not claiming exemption 30 TAC § 115.137(a)(1) or 30 TAC § 115.137(b)(1),
enter “NO” or leave this column blank.)
Loading Facility Storage Tank VOC Vapor Pressure Exemption:
Enter “YES” if the process contains storage tanks at loading facilities that store VOC with vapor pressure less than or
equal to 4.1 psia (28 kilopascals) at 68̊ F (20̊ C ). Otherwise, enter “NO.” (If not claiming exemption 30 TAC
§ 115.137(a)(2) or 30 TAC § 115.137(b)(2), enter “NO” or leave this column blank.)
In-Process Tanks:
Enter “YES” if the process includes in-process tanks that contain VOC. Otherwise, enter “NO.”
Vapor Recovery System:
Select one of the following options if the in-process tanks utilize a vapor recovery system to comply with an emission
specification in 30 TAC § 115.531 or a control requirement in 30 TAC § 115.532. If a vapor recovery system is not
utilized, enter “NONE.”
Code
Description
INC
Vapor recovery system with a direct-flame incinerator
SOLV
Vapor recovery system with a solvent recovery system other than a carbon adsorption system
CADS
Vapor recovery system with a carbon adsorption system
OTHER
Other control device
NONE
A vapor recovery system is not utilized to comply with an emission specification or control
requirement
Control Device ID No.:
If applicable, enter the identification number (ID No.) for the control device to which emissions are routed. This number
should be consistent with the control device identification number (maximum 10 characters) as listed on Form OP-SUM
(Individual Unit Summary).
Storage Tank VOC Vapor Pressure Exemption:
Enter “YES” if the process contains storage tanks containing VOC with a vapor pressure less than or equal to 1.5 psia
(10.3 kilopascals) at 68°F (20°C). Otherwise, enter “NO.” (If not claiming exemption 30 TAC § 115.137(a)(3) or30 TAC
§ 115.137(b)(3), enter “NO” or leave this column blank.)
Other Storage Tanks:
Enter “YES” if the process contains other storage tanks containing VOC with a vapor pressure greater than 1.5 psia
(10.3 kilopascals) at 68°F (20°C). Otherwise, enter “NO.”
Complete “Vapor Recovery System” only if “Other Storage Tanks” is “YES.”
Vapor Recovery System:
Select one of the following options if the process contains other storage tanks containing VOC with a vapor pressure
greater than 1.5 psia (10.3 kilopascals) at 68°F (20°C) that utilize a vapor recovery system to comply with an emission
specification in 30 TAC § 115.531 or a control requirement in 30 TAC § 115.532. If a vapor recovery system is not
utilized, enter “NONE.”
Code
Description
INC
Vapor recovery system with a direct-flame incinerator
SOLV
Vapor recovery system with a solvent recovery system other than a carbon adsorption system
CADS
Vapor recovery system with a carbon adsorption system
OTHER
Other control device
TCEQ - 10291 (v16, Revised 11/20) OP-UA34
This form is for use by sources subject to air quality permit
requirements and may be revised periodically. (Title V Release 09/20)
Page 5 of 6