ML25205A063
| ML25205A063 | |
| Person / Time | |
|---|---|
| Site: | Vogtle |
| Issue date: | 08/07/2025 |
| From: | Markley M NRC/NRR/DORL/LPL2-1 |
| To: | Coleman J Southern Nuclear Operating Co |
| References | |
| EPID L-2025-LLL-0010 | |
| Download: ML25205A063 (1) | |
Text
August 7, 2025 Jamie M. Coleman Regulatory Affairs Director Southern Nuclear Operating Company, Inc.
3535 Colonnade Parkway, Bin N-274-EC Birmingham, AL 35243
SUBJECT:
VOGTLE ELECTRIC GENERATING PLANT, UNITS 3 AND 4 -
AUTHORIZATION FOR USE OF HONEYWELL MURUROA V4F1 AND MTH2 ATMOSPHERE SUPPLYING AIR SUITS (EPID L-2025-LLL-0010)
Dear Ms. Coleman:
By letter dated June 27, 2025, as supplemented by letter dated July 16, 2025 (Agencywide Documents Access and Management System (ADAMS) Accession Nos. ML25178C655 and ML25197A596, respectively), pursuant to Title 10 of the Code of Federal Regulations (10 CFR)
Part 20, Standards for Protection Against Radiation, Subpart H, Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas, Section 20.1703, Use of individual respiratory protection equipment, paragraph (b), Southern Nuclear Operating Company (SNC, the licensee) requested U.S. Nuclear Regulatory Commission (NRC) authorization for use of respiratory protection equipment that has not been tested or certified by the National Institute for Occupational Safety and Health (NIOSH), for Vogtle Electric Generating Plant (VEGP), Units 3 and 4. This request includes Mururoa single-use, supplied air-suits (Models V4F1 and MTH2) manufactured by Honeywell Safety Products, Inc. In addition, pursuant to 10 CFR 20.1705, Application for use of higher assigned protection factors, SNC requested authorization to use an assigned protection factor (APF) of 5000 for the Mururoa V4F1 and MTH2 suits, which exceed the APFs specified in Subpart O, Appendix A, Assigned Protection Factors for Respirators, to 10 CFR Part 20.
SNC proposes to use Mururoa V4F1 and MTH2 supplied air suits without the standby rescue persons described by 10 CFR 20.1703(f), based on the safety features for the individual to quickly open the suit and extricate himself or herself in order to breathe outside air in case of a failure of the air supply. Upon NRC approval, these suits will be included as an option in the respiratory protection program for VEGP, Units 3 and 4.
The NRC staff has reviewed the application and concludes, as set forth in the enclosed safety evaluation, that the licensee has adequately addressed the regulatory requirements set forth in 10 CFR 20.1703(b) and 20.1705. Therefore, the NRC staff authorizes the use of the Mururoa V4F1 and MTH2 suits with an APF of 5,000 at the licensees facilities, as described in the application.
If you have any questions, please contact Ed Miller at 301-415-2481 or via email at Ed.Miller@nrc.gov.
Sincerely, Michael Markley, Chief Plant Licensing Branch II-1 Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket Nos.52-025 & 50-026
Enclosure:
Safety Evaluation cc: Listserv MICHAEL MARKLEY Digitally signed by MICHAEL MARKLEY Date: 2025.08.07 11:35:49 -04'00'
Enclosure SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION RELATED TO THE REQUEST FOR USE OF HONEYWELL MURUROA V4F1 AND MTH2 ATMOSPHERE SUPPLYING AIR SUITS WITH AN ASSIGNED PROTECTION FACTOR OF 5000 SOUTHERN NUCLEAR OPERATING COMPANY VOGTLE ELECTRIC GENERATING PLANT, UNITS 3 AND 4 DOCKET NOS.52-025 AND 52-026
1.0 PROPOSED CHANGE
By letter dated June 27, 2025, as supplemented by letter dated July 16, 2025 (Agencywide Documents Access and Management System (ADAMS) Accession Nos. ML25178C655 and ML25197A596), pursuant to Title 10 of the Code of Federal Regulations (10 CFR) Part 20, Standards for Protection Against Radiation, Subpart H, Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas, Section 20.1703, Use of individual respiratory protection equipment, paragraph (b), Southern Nuclear Operating Company (SNC, the licensee) requested U.S Nuclear Regulatory Commission (NRC) approval for authorized use of respiratory protection equipment that has not been tested or certified by the National Institute for Occupational Safety and Health (NIOSH), for Vogtle Electric Generating Plant (VEGP), Units 3 and 4. This request includes two Mururoa single-use, supplied air-suits (Models V4F1 and MTH2) manufactured by Honeywell Safety Products, Inc. In addition, pursuant to 10 CFR 20.1705, Application for use of higher assigned protection factors, SNC requested authorization to use an assigned protection factor (APF) of 5000 for the Mururoa V4F1 and MTH2 suits, which exceeds the APFs specified in Subpart O, Appendix A, Assigned Protection Factors for Respirators to 10 CFR Part 20.
SNC proposes to use Mururoa V4F1 and MTH2 supplied air suits without the standby rescue persons described by 10 CFR 20.1703(f), based on the safety features for the individual to quickly open the suit and extricate himself or herself in order to breathe outside air in case of a failure of the air supply. The licensee has also noted that these Mururoa suits have been identified as having benefits from contamination control, heat stress reduction, and respiratory protection viewpoints. Upon NRC staff approval, these suits will be included as an option in the respiratory protection program for VEGP, Units 3 and 4.
2.0 REGULATORY EVALUATION
This section summarizes the requirements and guidance used by the NRC staff to determine the sufficiency of the licensees authorization request and to provide a basis for the NRC staffs evaluation. In general, the NRC staffs acceptance uses the applicable 10 CFR Part 20 requirements as clarified by guidance in Regulatory Guide (RG) 8.15, Revision 1, Acceptable Programs for Respiratory Protection (ML003739528) October 1999 and NUREG/CR-0041, Revision 1, Manual of Respiratory Protection Against Airborne Radioactive Material (ML010310331) January 2001.
2.1 Requirements The NRC considered the following requirements in evaluating the licensees authorization request.
Section 1703(b) of 10 CFR Part 20 states:
If the licensee wishes to use equipment that has not been tested or certified by NIOSH, or for which there is no schedule for testing or certification, the licensee shall submit an application to the NRC for authorized use of this equipment except as provided in this part. The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use.
This must be demonstrated either by licensee testing or on the basis of reliable test information.
Section 1703(f) of 10 CFR Part 20 states:
Standby rescue persons are required whenever one-piece atmosphere-supplying suits, or any combination of supplied air respiratory protection device and personnel protective equipment are used from which an unaided individual would have difficulty extricating himself or herself. The standby persons must be equipped with respiratory protection devices or other apparatus appropriate for the potential hazards. The standby rescue persons shall observe or otherwise maintain continuous communication with the workers (visual, voice, signal line, telephone, radio, or other suitable means), and be immediately available to assist them in case of a failure of the air supply or for any other reason that requires relief from distress. A sufficient number of standby rescue persons must be immediately available to assist all users of this type of equipment and to provide effective emergency rescue if needed.
Section 1705 of 10 CFR Part 20 states:
The licensee shall obtain authorization from the Commission before using assigned protection factors in excess of those specified in Appendix A to part 20.
The Commission may authorize a licensee to use higher assigned protection factors on receipt of an application that (a) Describes the situation for which a need exists for higher protection factors; and
(b) Demonstrates that the respiratory protection equipment provides these higher protection factors under the proposed conditions of use.
Section 1003 of 10 CFR Part 20 defines APF as: the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF. The APFs for respirators are specified in Subpart O, Appendix A to 10 CFR Part 20 but this Appendix does not provide an APF for atmosphere supplying continuous flow suits. Additionally, Footnote (g) of 10 CFR Part 20, Appendix A states: No NIOSH approval schedule is currently available for atmosphere supplying suits. This equipment may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met (i.e., § 20.1703).
2.2 Guidance The following guidance documents were used during the NRC staffs evaluation:
Section 4.2, Non-NIOSH-Certified Equipment, of RG 8.15 states that an application to use a noncertified device should:
Explain why no existing NIOSH-certified device meets the licensee's need, Present evidence that the material quality and performance characteristics of the proposed device are capable of providing adequate respiratory protection to the wearer under the proposed conditions of use, and Show that using the device as proposed will not subject the wearer to undue physical or psychological stress or undue hazard.
Additionally, RG 8.15, section 4.2 states that When the NRC has granted authorization to use such a device to one licensee, subsequent applications by additional licensees may make use of test information in the original submittal.
Section 4.12.2, Supplied Air Suits Used With an APF, of RG 8.15 states, in part, that Conditions of use to be described in the application would include the anticipated length of air supply hose (minimum and maximum) and breathing air supply pressure (minimum and maximum).
Section 4.10.1, Exemptions for Non-NIOSH-Certified Devices, of NUREG/CR-0041 states, in part, that Where an exemption for use of such a device has already been granted to a licensee by the Commission, subsequent applications by additional licensees may make use of test information previously submitted. As described in the approval letters to Entergy Operations, Inc. (Entergy) dated August 14, 2006, DTE Electric Company (DTE) dated July 29, 2015, and Arizona Public Service Company (APS) dated September 13, 2023 (ML062230266, ML15155A506, and ML23241B018, respectively), the NRC has previously granted an authorization to use the Mururoa MTH2 and V4F1 supplied air suits when they were manufactured by Delta Protection, France. In the letter dated July 29, 2015, per SE Section 1.0, the Mururoa suit systems were developed and manufactured by Delta Protection, which was owned by Bacou-Dalloz (a French protective equipment company). In 2007 Bacou-Dalloz changed its name to Sperian Protection. Sperian Protection was acquired
subsequently by Honeywell Safety Products, Inc. As stated in the NRC staffs safety evaluation dated July 29, 2015, Honeywell Safety Products, Inc. has confirmed that the change in ownership of Delta Protection does not impact the manufacture, form, fit, or function of the Mururoa MTH2, V4F1 or BLU suits, nor the third-party certification testing referenced [in prior NRC approvals of this equipment].
For the safety evaluation dated July 29, 2015, the NRC staff referenced European Standard EN 1073-1: 1998, Protective Clothing Against Radioactive Contamination, as referenced in the licensees authorization request. The NRC staff has previously found that this standard is consistent with testing criteria used to authorize the use of air-supplied suits at Department of Energy facilities. The NRC staff has used the results of this testing program to inform approvals of equipment not certified by NIOSH, as noted in the NRC staffs approval letter to Entergy dated August 14, 2006, and APS by letter dated September 13, 2023.
3.0 TECHNICAL EVALUATION
The NRC staff evaluated the licensees authorization request to use the Honeywell Mururoa MTH2 and V4F1 supplied air suits to confirm that the requirements in Section 2.1 of this SE were met, as clarified by the guidance in Section 2.2 of this SE. The NRC also considered guidance in NUREG/CR-0041, Section 4.10.1. The NRC staff also considered relevant information from precedents in the approval letters dated August 14, 2006, July 29, 2015, and September 13, 2023.
In Section 3.1 of the SNCs authorization request, the licensee explained why NIOSH-certified equipment does not meet its needs, per RG 8.15, Section 4.2. In summary, the proposed V4F1 and MTH2 equipment provides advantages in the quality of respiratory protection, reduced risk of radioactive cross-contamination, heat stress prevention over NIOSH-approved equipment, and improved self-extrication without the need for standby rescue personnel. Consistent with its prior SEs for Entergy, DTE, and APS, the NRC staff finds that the design and safety features of the proposed V4F1 and MTH2 supplied air suits provide advantages over NIOSH-approved respiratory protection equipment.
In Enclosure 2 to its submittal dated June 27, 2025, the licensee provided a List of Regulatory Commitments. These commitments are described below as Table 1 of this SE. The licensees commitments cover key areas such as training; instructions for storage, repair, selection, inspection, and use of the equipment; exclusion on use in environments that are considered immediately dangerous to life and health (IDLH); and breathing air specifications. The NRC does not approve licensee commitments in its authorization of the licensees request to use V4F1 and MTH2 supplied air suits but does acknowledge the self-imposed conforming changes in its implementation of this authorization. The commitments identified in Enclosure 2 of the licensees submittal and Table 1 of this SE are intended to follow industry guidance in Nuclear Energy Institute (NEI) 99-04, Revision 0, Guidelines for Managing NRC Commitment Changes, dated July 1999 (ML003680088) and NRC Regulatory Issue Summary 2000-17, Managing Regulatory Commitments Made by Power reactor Licensees to the NRC Staff, dated September 21, 2000 (ML003741774). The NRC maintains the Reactor Oversight Program which verifies ongoing implementation of programs such as this one.
Table 1 - Enclosure 2 to NL-25-0234, List of Regulatory Commitments REGULATORY COMMITMENT DUE DATE SNC will modify the respiratory protection program to provide training and additional written instructions, as follows:
- 1) Training
- a. Revise or develop written lesson plans and train workers in:
- i. The features of this equipment, ii. How to don, use and doff this equipment; and iii. Using the built-in escape strips for routine and emergency egress conditions. The training will include appropriate hands-on and classroom instruction and will include actions to be taken by the user in the event of equipment malfunction.
- b. Additional training to personnel responsible for implementation of the respiratory protection program to assist in selection, issuance, set-up and operation of this equipment.
- 2) Instructions for storage, repair, selection, inspection and use of this equipment:
- a. Discard this equipment after a single use,
- b. Do not use in an environment immediately dangerous to life and
- health,
- c. Prohibit contact with open flames or grinding/welding sparks,
- d. Use with an assigned protection factor of 5,000,
- e. Comply with manufacturers recommendations for shelf-life and storage conditions for this equipment,
- f.
Perform no maintenance or repair,
- g. Inspect this equipment at or near time of issue for tears, defects in material, presence of required zippers and integrity of seams and air distribution and exhaust systems, and
- h. Wearer to perform an operational check after donning and before exposure to airborne contaminants.
Prior to first use of this equipment.
SNC will revise its respiratory protection program to:
- 1) Include this equipment,
- 2) Establish pressure ranges for various hose lengths that will ensure appropriate air flow is provided to the user,
- 3) Incorporate specific instructions into the respiratory protection program to ensure that the air is supplied to the suit inlet consistent with the conditions for which this equipment was certified,
- 4) Include aspects of the training program outlined above, and
- 5) Provide written instructions for respiratory problem identification and communication.
Prior to first use of this equipment.
3.1 Evaluation of Material and Performance Characteristics In Section 3.2 of SNCs request dated June 27, 2025, the licensee provides information regarding material performance and physical characteristics, discusses certain attachments to
meet regulatory requirements and guidance, testing results and conditions of proposed use, and applicability of precedent NRC licensing approvals.. Attachments included:
- 2) European Standard EN 1073-1:1998 for Ventilated Protective Clothing
- 3) Certificate No. 0073/197/162/01/96/0001 for Mururoa MTH2 Supplied Air Suit
- 4) Mururoa MTH2 Supplemental Test Results
- 5) Certificate No. 0073/197/162/12/97/0028 for the Mururoa V4F1 Supplied Air Suit
- 6) Mururoa V4F1 Supplemental Test Results
- 7) Mururoa MTH2 and V4F1 Instructions for Use The licensee provided specific results for tests of abrasion, puncture and tear resistance, flammability, fit factor, seam resistance, vision distortion, suit pressure, carbon dioxide content in inhalation air, and noise level. The licensee stated that the air suits meet the certification criteria of European Standard EN 1073-1 and that the Honeywell Mururoa MTH2 and V4F1 supplied air suits are certified for protection against radioactive contamination when used as specified by the manufacturer and in accordance with air flow requirements in Table 1 of this SE. As described in section 3.4 of the licensees authorization request, to establish conditions at the air distribution manifold that are necessary to ensure that the air supplied to the suit inlet is consistent with certification requirements, SNC proposes to establish a range of pressures for various lengths of hoses that will ensure the wearer receives the specified air flow rates. These manifold pressure ranges will be controlled as provided in table 1 of this SE, which is consistent with the guidance provided in RG 8.15, section 4.12.2.
In Section 3.2.2 of the submittal dated June 27, 2025, the licensee stated that the Honeywell Mururoa MTH2 and V4F1 supplied air suits are: (1) for single-use only, (2) are to protect against airborne radioactivity and contamination, but are not intended for environments immediately dangerous to life and health (IDLH)
The licensee requests a departure from the requirement for standby rescue persons in accordance with 10 CFR 20.1703(f) on the basis that the Honeywell Mururoa MTH2 and V4F1 supplied-air suits offer quick self-extrication without the need for additional personnel. In its letter dated July 16, 2025, the licensee lists the following safety features which obviate the need for a standby rescue person and demonstrate that the device as proposed will not subject the wearer to undue physical or psychological stress or undue hazard:
An egress strip stretching from left arm, over the head, to right arm that is normally used for undressing and can be used for self-rescue during an emergency, such as loss of supplied air; A removable strip covering an opening near the mouth that could be used for emergency breathing in case of loss of supplied air; Two exhaust valves that provide ventilation, and protect from overpressure; and Air intake located at the waist with a built-in control valve that can adjust, but not block, air flow.
The NRC staff finds that the suit design provides for sufficient and effective self-extracation and rescue, thereby, avoiding asphyxiation if the air supply is interrupted or lost. This is consistent with Section 3.4 of the NRC staff approval letter to Entergy dated August 14, 2006. Due to these design features of the suits, coupled with required training of all suit users on escape methods, and limiting the use of the suits to non-IDLH atmospheres, as described in Table 1 of this SE, the NRC staff has reasonable assurance that standby rescue persons, as described in 10 CFR 20.1703(f), need not be required when using Honeywell Mururoa MTH2 and V4F1 supplied air suits.
Based on the above, the NRC staff determined that the material and performance characteristics of the Honeywell Mururoa MTH2 and V4F1 supplied air suits are sufficient for providing the proposed degree of protection under anticipated conditions of use when used within the manufactures specifications and is therefore, acceptable.
3.2 Evaluation of the Need for Higher APFs and Demonstration of Ability to Provide a Higher APF In Sections 3.2.2, 3.3, and 3.4 of its submittal dated June 27, 2025, the licensee provides information supporting its need for and ability to provide a higher APF, consistent with prior authorization requests approved by the NRC staff. Typically, the conditions for use of the equipment include potentially high contamination and/or high airborne radioactivity, such as open steam generator manways and steam generator platform work, reactor cavity decontamination, control rod drive exchange, and equipment decontamination. The higher APF enables the licensee to take credit for the protection capability to which the suits are certified.
Without approval of a higher APF, SNC would have to estimate doses to individuals based on the ambient concentration of airborne radioactive materials in the air, thereby overestimating worker exposures and limiting stay times. Therefore, the NRC staff finds that the application describes a situation for which a need exists for higher APFs. Additionally, the NRC staff notes that this equipment has been approved and used at other NRC licensed facilities with an APF of 5000 (e.g., Entergy, DTE, and APS). The SNCs proposal is consistent with the prior NRC staff approvals.
As a demonstration that the suits can provide the proposed APF of 5000, in the certificates included with the authorization request, Certificate No. 0073/197/162/01/96/0001 for Mururoa MTH2 Supplied Air Suit and Certificate No. 0073/197/162/12/97/0028 for the Mururoa V4F1 Supplied Air Suit, state that the suits were tested in accordance with European Standard EN 1073-1, passed in all categories tested, and provided a protection factor greater than 50,000.
Based on the above, SNC states that an APF of 5000 is more conservative.
As described in section 3.1.2 of the NRC staff approval letter to DTE dated July 29, 2015, the NRC has previously accepted testing and qualification conducted under European Standard EN 1073-1: 1998 as a basis for granting authorization for use of the Honeywell Mururoa MTH2 and V4F1 supplied air suits. The NRC staff continues to hold that such testing provides adequate basis for characterizing the performance of the equipment and the proposed degree of protection under anticipated conditions of use and that allowing an APF of 5000 provides a conservative safety factor for estimating the actual protection provided to the user by the suits in the actual working environment. Therefore, the NRC concludes that use of an APF of 5000 for the Honeywell Mururoa MTH2 and V4F1 supplied air suits is acceptable.
3.3 Demonstration that Requirements of 10 CFR 20.1703, with the exception of fit testing, continue to be met As indicated in Section 2.1 of this SE, footnote (g) of 10 CFR Part 20, Appendix A tates, in part, that atmosphere supplying suits, may be used in an acceptable respiratory protection program as long as all the other minimum program requirements, with the exception of fit testing, are met (i.e., 10 CFR 20.1703). The respiratory protection requirements on the use of individual respiratory protection equipment are provided in 10 CFR 20.1703. The NRC staff reviewed the authorization request to verify that there was reasonable assurance that the Honeywell Mururoa MTH2 and V4F1 supplied air suits could be used in the licensees respiratory protection programs in accordance with the applicable requirements of 10 CFR 20.1703.
In Section 3.5 of the licensees submittal dated June 27, 2025, the licensee states that SNC implements respiratory protection programs in compliance with 10 CFR 20.1703 and that the program only permits the use of respiratory protection equipment that has been tested and certified by NIOSH, pursuant to the requirements of 10 CFR 20.1703(a). The NRC staff notes that VEGP, Units 3 and 4, are under the NRCs Reactor Oversight Process, which provides for biennial inspections of licensees use of respiratory protection to limit the intake of radioactive materials per NRC Inspection Manual, Inspection Procedure 71124, Attachment 03, In-Plant Airborne Radioactivity Control and Mitigation, effective date January 1, 2020 (ML19253D103).
As described in Section 3.6 of the licensees submittal dated June 27, 2025, the licensee will use its existing 10 CFR Part 50, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, Criterion XVI credited corrective action program to communicate identified problems with this equipment to the vendor and the rest of the nuclear industry. The SNC respiratory protection program will be revised to provide written instructions for respiratory problem identification and communication, as provided in Enclosure 2 of its submittal and Table 1 of this SE.
Based on the above, the NRC staff concludes that there is reasonable assurance that the applicable requirements of 10 CFR 20.1703 for the licensees respiratory protection program, will continue to be met if the Honeywell Mururoa MTH2 and V4F1 supplied air suits are used as described in the licensees authorization request.
4.0 CONCLUSION
As discussed above, based on the testing data previously reviewed by the NRC staff in the Entergy, DTE, and APS requests, the proposed conditions of use as provided in the licensees submittal, as supplemented, including the applicable manufacturers instructions and the licensees proposed controls in accordance with industry guidance, and requirements of 10 CFR Part 20, Subpart H, the NRC staff concludes that the licensees request to use the Honeywell Mururoa MTH2 and V4F1 supplied air suits is sufficient to meet the requirements of 10 CFR 20.1703(b) and 20.1705. The NRC staff finds that the Honeywell Mururoa MTH2 and V4F1 supplied air suits will provide the wearer with an adequate level of protection for working in high and potentially high airborne radioactivity and contamination areas and is, therefore, acceptable. The NRC staff also concludes that SNC has sufficiently justified the use with an APF of 5000. Therefore, the NRC authorizes the use of the Honeywell Mururoa MTH2 and V4F1 supplied air suits as an option in the respiratory protection program at VEGP, Units 3 and
- 4.
Principal Contributor: W. Rautzen, NRR Date: August 7, 2025
ML25205A063 OFFICE NRR/DORL/LPL2-1/PM NRR/DORL/LPL2-1/LA NRR/DRA/ARCB/BC NAME GEMiller KZeleznock (KEntz for)
KHsueh DATE 7/29/2025 7/28/2025 8/1/2025 OFFICE NRR/DORL/LPL2-1/BC NAME MMarkley DATE 8/7/2025