ML23241B018
| ML23241B018 | |
| Person / Time | |
|---|---|
| Site: | Palo Verde  |
| Issue date: | 09/13/2023 |
| From: | Siva Lingam Plant Licensing Branch IV |
| To: | Heflin A Arizona Public Service Co |
| Lingam S, 301-415-1564 | |
| References | |
| EPID L-2023-LLL-0009 | |
| Download: ML23241B018 (12) | |
Text
September 13, 2023 Mr. Adam C. Heflin Executive Vice President/
Chief Nuclear Officer Mail Station 7605 Arizona Public Service Company P.O. Box 52034 Phoenix, AZ 85072-2034
SUBJECT:
PALO VERDE NUCLEAR GENERATING STATION, UNITS 1, 2, AND 3 - USE OF HONEYWELL MURUROA V4F1 AND MTH2 SUPPLIED AIR SUITS WITHIN RESPIRATORY PROTECTION PROGRAM (EPID L-2023-LLL-0009)
Dear Mr. Heflin:
By letter dated April 12, 2023, 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), Arizona Public Service Company (APS, 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 Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Palo Verde). This request includes two MURUROA single-use, supplied air-suits (Models V4F1 and MTH2). In addition, pursuant to 10 CFR 20.1705, Application for use of higher assigned protection factors, APS requested an assigned protection factor (APF) of 5,000 for the MURUROA V4F1 and MTH2 suits, which exceed the APFs specified in Appendix A, Assigned Protection Factors for Respirators to 10 CFR Part 20.
APS 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 to quickly open the suit in order to breathe outside air in the event that a loss of supplied air occurs. Upon NRC approval, these suits will be included as an option in the Palo Verde respiratory protection program.
Enclosed is the NRC staffs safety evaluation that authorizes APS to use the Honeywell Mururoa MTH2 and V4F1 supplied air suits, with an APF of 5,000, as described in the application.
If you have any questions, please contact me at (301) 415-1564 or via email at Siva.Lingam@nrc.gov.
Sincerely,
/RA by Dennis J. Galvin for/
Siva P. Lingam, Project Manager Plant Licensing Branch IV Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket Nos. STN 50-528, STN 50-529, and STN 50-530
Enclosure:
Safety Evaluation cc: Listserv
Enclosure SAFETY EVALUATION BY THE OFFICE OF NUCLEAR REACTOR REGULATION RELATED TO THE REQUEST FOR USE OF HONEYWELL PROTECTION MURUROA V4F1 AND MTH2 SUPPLIED AIR SUITS WITH AN ASSIGNED PROTECTION FACTOR OF 5000 ARIZONA PUBLIC SERVICE COMPANY, ET AL.
PALO VERDE NUCLEAR GENERATING STATION, UNITS 1, 2, AND 3 DOCKET NOS. STN 50-528, STN 50-529, AND STN 50-530
1.0 PROPOSED CHANGE
By letter dated April 12, 2023 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML23102A329), 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), Arizona Public Service Company (APS) 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 Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Palo Verde). This request includes two MURUROA single-use, supplied air-suits (Models V4F1 and MTH2). In addition, pursuant to 10 CFR 20.1705, Application for use of higher assigned protection factors, APS requested an assigned protection factor (APF) of 5,000 for the MURUROA V4F1 and MTH2 suits, which exceeds the APFs specified in Appendix A, Assigned Protection Factors for Respirators to 10 CFR Part 20.
APS 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 to quickly open the suit in order to breathe outside air in the event that a loss of supplied air occurs. 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 Palo Verde respiratory protection program.
2.0 REGULATORY EVALUATION
This section summarizes the requirements and guidance used by the NRC staff to determine the adequacy of the licensees authorization request and to provide a basis for the NRC staffs approval. 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) and NUREG/CR-0041, Revision 1, Manual of Respiratory Protection Against Airborne Radioactive Material (ML010310331).
2.1 Requirements The following regulations apply to the NRC staffs evaluation of this 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 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., 10 CFR 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, and DTE Electric Company (DTE) dated July 29, 2015 (ML062230266 and ML15155A506, 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 subsequently acquired by Honeywell Safety Products, Inc. As stated in the NRC staffs 2015 SE, 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 this SE, 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.
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 listed in section 2.1 of this SE were met, as clarified by the guidance in section 2.2 of this SE. Based on 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, and July 29, 2015, during its evaluation.
In section 3.1 of the licensees authorization request, the licensee explained why NIOSH-certified equipment does not meet its needs, per RG 8.15, section 4.2. In summary, the equipment provides advantages in the quality of respiratory protection, protection from radioactive contamination and heat stress prevention over NIOSH-approved equipment. The NRC staff continues to find that the design and safety features of supplied air suits provide advantages over NIOSH-approved respiratory protection equipment, as described in the NRC staffs approval letter to Entergy dated August 14, 2006, as the approval was for the same supplied air suit, the MURUROA V4F1, and the MURUROA MTH2 is essentially identical with the same safety and design features, except it is made from different material, as discussed in Section 3.1.1 of the NRC staffs 2015 SE.
Additionally, table 1 of this SE, which is designated as table 1, List of Regulatory Commitments in the licensees authorization request, identifies actions the licensee intends to take to incorporate the Honeywell Mururoa MTH2 and V4F1 supplied air suits within its existing respiratory protection program after the NRC staff approval is granted. These actions are captured as commitments in the licensees authorization request. These 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 staff considers these commitments to be part of the conditions of use, as described below. The NRC staff has determined that the commitments in table 1 do not warrant the creation of regulatory requirements, which would require prior NRC approval of changes that are introduced after the authorization to use the equipment is issued, which is consistent with section 3.5 of the NRC staff approval letter to Entergy dated August 14, 2006. Instead, the commitments identified in table 1 should be controlled in accordance with industry guidance or comparable criteria employed by APS. 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), provide guidance for the control of regulatory commitments made by licensees. The NRC staff may verify the implementation and maintenance of commitments during oversight activities (e.g., inspections).
Table 1 - Actions committed to by APS in order to use the Honeywell Mururoa V4F1 and MTH2 air-supplied suit at Palo Verde REGULATORY COMMITMENT DUE DATE APS 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.
APS 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 This section provides the NRC staffs evaluation of the evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use.
In section 3.2 of the licensees authorization request, the licensee provides information regarding material performance and physical characteristics, and indicates consistency with prior authorization requests approved by the NRC. Specifically, the licensees authorization request included the following information:
- 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 information above provides 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. These results, as provided by the licensee, meet the certification criteria of European Standard EN 1073-1 and ensure that the Honeywell Mururoa MTH2 and V4F1 supplied air suits are certified for protection against radioactive contamination when used as specified by the manufacturer, in particular, with regard to air flow requirements as committed to in table 1. 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, APS 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, which is consistent with the guidance provided in RG 8.15, section 4.12.2.
In section 3.2.2 of the licensees authorization request, the licensee stated that the Honeywell Mururoa MTH2 and V4F1 supplied air suits are not anticipated for use in IDLH environments. As stated in table 1 of this safety evaluation, the licensee committed that the Honeywell Mururoa MTH2 and V4F1 supplied air suits will not be used in an IDLH environment.
Regarding the requirement for standby rescue persons provided in 10 CFR 20.1703(f), the licensee proposes to use the Honeywell Mururoa MTH2 and V4F1 supplied air suits without standby rescue persons because an unaided individual would not have difficulty extricating themselves from the suit, if necessary. Section 3.2.2 of the licensees authorization request 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 based on these safety features, the suit design provides for easy and effective self-rescue, thus, avoiding asphyxiation if the air supply is interrupted or lost, which is also, for example, 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, the NRC staff has reasonable assurance that standby rescue persons, as described in 10 CFR 20.1703(f), are not required when using Honeywell Mururoa MTH2 and V4F1 supplied air suits.
Based on the above, the NRC staff determined that, in accordance with 10 CFR 20.1703(b), the material and performance characteristics of the Honeywell Mururoa MTH2 and V4F1 supplied air suits are capable of providing the proposed degree of protection under anticipated conditions of use, which includes being used within the manufactures specifications.
3.2 Evaluation of the Need for Higher APFs and Demonstration of Ability to Provide a Higher APF In this section the NRC staff verified that the application describes the situation for which a need exists for higher APFs and demonstrates that the respiratory protection equipment provides these higher APFs under the proposed conditions of use, in accordance with the requirements in 10 CFR 20.1705.
In sections 3.2.2, 3.3. and 3.4 of the licensees authorization request, the licensee provides information regarding the need for and ability to provide a higher APF, consistent with prior authorization requests approved by the NRC staff. Specifically, the conditions for use of the equipment include potentially high contamination and/or high airborne radioactivity, such as 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, APS would have to estimate doses to individuals based on the ambient concentration of airborne radioactive materials in the air, obviating the benefits of using this equipment. 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 for use at other NRC licensed facilities with an APF of 5,000 (e.g., Entergy and DTE); and APSs proposal is consistent with the prior NRC staff approvals.
As a demonstration that the suits can provide the proposed APF of 5,000, 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.
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 5,000 provides a conservative safety factor for estimating the actual protection provided to the user by the suits in the actual working environment. Therefore, use of an APF of 5,000 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 provides, 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 authorization request, the licensee states that APS implements respiratory protection programs in compliance with 10 CFR 20.1703. The NRC staff notes that Palo Verde is 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 Radioactivey Control and Mitigation, effective date January 1, 2020 (ML19253D103).
As described in section 3.6 of the licensees authorization request, 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. APS respiratory protection program will be revised to provide written instructions for respiratory problem identification and communication, as provided in table 1.
Based on its review of the authorization request, as discussed in this section, the NRC staff has 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 and DTE requests; the conditions of use as provided in the licensees application including the applicable manufacturers instructions and the licensees commitments, 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 meets the requirements of 10 CFR 20.1703(b) and 20.1705 for use. The NRC staff finds that the Honeywell Mururoa MTH2 and V4F1 supplied air suits will provide the wearer with an adequate level of protection while
working in high and potentially high airborne radioactivity areas. Therefore, the NRC staff authorizes APS to use the Honeywell Mururoa MTH2 and V4F1 supplied air suits at Palo Verde, with an APF of 5,000, as described in the application.
Principal Contributor: D. Garmon-Candelaria, NRR Date: September 13, 2023
- by email **SE memorandum by email OFFICE NRR/DORL/LPL4/PM*
NRR/DORL/LPL4/LA*
NRR/DRA/ARCB/BC**
NAME SLingam PBlechman KHsueh DATE 8/29/2023 8/30/2023 8/24/2023 OFFICE OGC - NLO NRR/DORL/LPL4/BC*
NRR/DORL/LPL4/PM*
NAME MWoods JDixon-Herrity SLingam (DGalvin for)
DATE 9/11/2023 9/12/2023 9/13/2023