ML25269A159

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Additional Context and Justification to Support the Removal of 10 CFR 70.64, Requirements for New Facilities or New Processes at Existing Facilities
ML25269A159
Person / Time
Site: Nuclear Energy Institute
Issue date: 09/23/2025
From: Core G
Nuclear Energy Institute
To: Andrea Kock
Office of Nuclear Material Safety and Safeguards
References
Download: ML25269A159 (1)


Text

Greg Core Director, Fuel Cycle Facilities and Transportation Phone: 202.407.2074 Email: gmc@nei.org September 23, 2025 Ms. Andrea Kock Acting Director, Office of the Nuclear Materials Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

Additional Context and Justification to Support the Removal of 10 CFR 70.64, Requirements for New Facilities or New Processes at Existing Facilities Project Number: 689

Dear Ms. Kock:

The Nuclear Energy Institute (NEI)1, on behalf of its members, appreciates the opportunity to provide additional context on a recommendation originally submitted to the Nuclear Regulatory Commission (NRC) in a July 31, 2025, report, Accelerating NRC Reform2. Specifically, this letter elaborates on the recommendation to remove 10 CFR 70.64, "Requirements for New Facilities or New Processes at Existing Facilities," from the NRCs regulations.

NEI recognizes and supports the NRCs mission to ensure safety and security in the civilian use of radioactive materials. However, we respectfully submit that § 70.64 is not necessary to accomplish these objectives and, in its current form, may contribute to regulatory inefficiency. This regulation imposes generic design requirements on fuel cycle facilities, despite the reality that such facilities differ significantly in baseline design, operational purpose, and risk profile.

Further, many of the elements required under § 70.64 are either redundant with existing NRC regulations or already addressed by widely accepted codes and standards, such as those issued by the American Nuclear Society or the International Code Council. This redundancy adds regulatory burden without a corresponding safety benefit.

1 The Nuclear Energy Institute (NEI) is responsible for establishing unified policy on behalf of its members relating to matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect and engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations involved in the nuclear energy industry.

2 https://www.nrc.gov/docs/ML2521/ML25213A112.pdf

Ms. Andrea Kock September 23, 2025 Page 2 Nuclear Energy Institute Removing § 70.64 would enhance regulatory clarity, reduce duplication, and allow the NRC and licensees to better allocate resources toward risk-informed oversight and compliance activities. This proposal aligns with the principles of regulatory efficiency and effectiveness that the Commission has consistently endorsed.

Attached to this letter is an addendum providing additional detail and rationale supporting this recommendation. We encourage the NRC staff to consider this input as part of broader efforts to modernize its regulatory framework.

Please do not hesitate to contact me at gmc@nei.org or (202) 407-2074 should you require further information or wish to discuss this matter in greater detail. NEI remains committed to working with the Commission to ensure a safe, efficient, and predictable regulatory environment.

Thank you for your consideration.

Sincerely, Greg Core Director, Fuel Cycle Facilities and Transportation

Attachment:

Increasing Regulatory Efficiency through the Removal of 10 CFR 70.64 Cc:

Shana Helton - Director, Division of Fuel Management Samantha Lav - Chief, Fuel Facility Licensing Branch James Downs - Sr. Project Manager, Fuel Facilities Licensing Branch

Ms. Andrea Kock September 23, 2025 Page 3 Nuclear Energy Institute Increasing Regulatory Efficiency through the Removal of 10 CFR 70.64 Introduction As originally promulgated in September 20003, the baseline design criteria contained within 10 CFR 70.64 represent good engineering practice(s), and require applicants to include those provisions in new facilities or processes. These provisions may or may not have any nexus with licensed material. The NRC also stated in 2000 that these requirements do not provide relief from compliance with the performance requirements of § 70.61 and therefore an applicant must still prove that the facility adequately prevents or mitigates high or intermediate consequence events and nuclear criticality accidents using Items Relied on for Safety (IROFS). Given the above characteristics of the requirements in § 70.64, they are usually satisfied through meeting other regulatory requirements from the NRC or other authorities having jurisdiction. As such, their inclusion as separate requirements creates regulatory redundancies.

Each component of § 70.64 is provided below with the industrys recommendation and corresponding basis.

§ 70.64 Requirements for new facilities or new processes at existing facilities.

(a) Baseline design criteria. Each prospective applicant or licensee shall address the following baseline design criteria in the design of new facilities. Each existing licensee shall address the following baseline design criteria in the design of new processes at existing facilities that require a license amendment under

§ 70.72. The baseline design criteria must be applied to the design of new facilities and new processes, but do not require retrofits to existing facilities or existing processes (e.g., those housing or adjacent to the new process); however, all facilities and processes must comply with the performance requirements in § 70.61. Licensees shall maintain the application of these criteria unless the analysis performed pursuant to

§ 70.62(c) demonstrates that a given item is not relied on for safety or does not require adherence to the specified criteria.

Recommendation: Remove.

Justification: The recommendations provided below to either remove or relocate items currently required under § 70.64 will nullify this paragraph and therefore it should be removed.

(1) Quality standards and records. The design must be developed and implemented in accordance with management measures, to provide adequate assurance that items relied on for safety will be available and reliable to perform their function when needed. Appropriate records of these items must be maintained by or under the control of the licensee throughout the life of the facility.

3 https://www.federalregister.gov/documents/2000/09/18/00-23354/domestic-licensing-of-special-nuclear-material-possession-of-a-critical-mass-of-special-nuclear

Ms. Andrea Kock September 23, 2025 Page 4 Nuclear Energy Institute Recommendation: Remove Justification: This requirement is redundant to 70.62(d) where proper control of design, procurement, implementation, and maintenance are required for IROFS. NUREG-1520 provides further guidance related to 70.62(d).

(2) Natural phenomena hazards. The design must provide for adequate protection against natural phenomena with consideration of the most severe documented historical events for the site.

Recommendation: Remove Justification: This requirement is redundant to § 70.62(c)(1)(iv) which requires proper assessment of natural phenomena hazards when considering accident sequences in the Integrated Safety Analysis (ISA). Furthermore, local building authorities impose requirements to follow national and international building codes such as the International Building Code (IBC). In general, these codes provide minimum requirements to ensure that structures are designed and built to protect public health, safety, and the general welfare of occupants, including during natural phenomena events.

Adherence to these codes duplicates this requirement, further justifying its removal.

(3) Fire protection. The design must provide for adequate protection against fires and explosions.

Recommendation: Remove Justification: This requirement is redundant to § 70.62(c)(1)(iv) as an applicant must also assess fires when considering accident sequences in the ISA. Chapter 7 of NUREG-1520 provides guidance for the review and acceptance of this key area. Furthermore, local building authorities impose requirements to follow national and international building codes such as the International Building Code (IBC). In general, these codes provide minimum requirements to ensure that structures are designed and built to protect public health, safety, and the general welfare of occupants, including during fires. Therefore, the requirement is redundant and should be removed.

(4) Environmental and dynamic effects. The design must provide for adequate protection from environmental conditions and dynamic effects associated with normal operations, maintenance, testing, and postulated accidents that could lead to loss of safety functions.

Recommendation: Remove

Ms. Andrea Kock September 23, 2025 Page 5 Nuclear Energy Institute Justification: This requirement is redundant to § 70.62(c)(1)(iii) and (iv) which require proper assessment of internal, external, and facility hazards when considering accident sequences in the Integrated Safety Analysis (ISA).

(5) Chemical protection. The design must provide for adequate protection against chemical risks produced from licensed material, facility conditions which affect the safety of licensed material, and hazardous chemicals produced from licensed material.

Recommendation: Remove Justification: This requirement is redundant to § 70.61(b)(4), § 70.61(c)(4), and § 70.62(c)(ii) which require assessing chemical risks related to licensed material and ensuring those risks meet performance criteria. Chapter 6 of NUREG-1520 provides guidance for the review and acceptance of this key area.

(6) Emergency capability. The design must provide for emergency capability to maintain control of:

(i) Licensed material and hazardous chemicals produced from licensed material; (ii) Evacuation of on-site personnel; and (iii) Onsite emergency facilities and services that facilitate the use of available offsite services.

Recommendation: Remove Justification: This requirement is redundant to § 70.22(i)(1)(ii) and § 70.22(i)(3), which require applications to include emergency plans and specifications for those emergency plans, respectively.

(7) Utility services. The design must provide for continued operation of essential utility services.

Recommendation: Remove Justification: While not wholly redundant, continued operation of essential utility services such as electrical power to meet the performance criteria described in § 70.61 would be defined as an IROFS and thus maintained as such under § 70.62. § 70.62(c)(1)(iii) and (iv) requires proper assessment of internal, external, and facility hazards when considering accident sequences in the Integrated Safety Analysis (ISA).

Ms. Andrea Kock September 23, 2025 Page 6 Nuclear Energy Institute (8) Inspection, testing, and maintenance. The design of items relied on for safety must provide for adequate inspection, testing, and maintenance, to ensure their availability and reliability to perform their function when needed.

Recommendation: Remove Justification: This requirement is redundant to § 70.62(d) which requires IROFS be designed, implemented, and maintained to ensure they are available and reliable to perform their function when needed Chapter 11 of NUREG-1520 provides guidance for the review and acceptance of this key area.

(9) Criticality control. The design must provide for criticality control including adherence to the double contingency principle.

Recommendation: Modify existing § 70.61(d) to read: including the use of an approved margin of subcriticality for safety and adherence to the double contingency principle. (italics added to new wording)

Justification: This requirement is generally covered by § 70.22(a)(8) and § 70.61(d) which require all nuclear processes to remain subcritical in normal and credible abnormal conditions. Also, Chapter 5 of NUREG-1520 acknowledges the multiple overlapping criticality control requirements in the regulation and describes acceptable methods for meeting the criticality control requirements listed above, including the use of the double contingency principle. However, the term double contingency principle is only contained in § 70.64. The above modification streamlines the regulations.

(10) Instrumentation and controls. The design must provide for inclusion of instrumentation and control systems to monitor and control the behavior of items relied on for safety.

Recommendation: Modify existing § 70.61(e) to read: The safety program, established and maintained pursuant to § 70.62 of this subpart, shall ensure that each item relied on for safety will be available and reliable to perform its intended function when needed and in the context of the performance requirements of this section. For variables and physical systems pertaining to items relied on for safety, instrumentation shall be provided to monitor them over their anticipated ranges.

Appropriate controls shall be provided to maintain these variables and physical systems within prescribed operating ranges. (italics added to new wording)

Justification: While the clarification in § 70.61(e) may not be required, the above serves as a method of reducing redundancy and allows the existing § 70.64 to be removed completely.

Ms. Andrea Kock September 23, 2025 Page 7 Nuclear Energy Institute (b) Facility and system design and facility layout must be based on defense-in-depth practices. The design must incorporate, to the extent practicable:

(1) Preference for the selection of engineered controls over administrative controls to increase overall system reliability; and (2) Features that enhance safety by reducing challenges to items relied on for safety.

Recommendation: Relocate this element to a new element in § 70.62(a), Safety program, and define Defense-in-depth in § 70.4 using existing wording in the footnote of § 70.62(b): A design philosophy, applied from the outset and through completion of the design, that is based on providing successive levels of protection such that health and safety will not be wholly dependent upon any single element of the design, construction, maintenance, or operation of the facility.

Justification: While defense-in-depth practices are a nuclear industry standard and elements are specified throughout NRCs regulations and policies, this requirement is not redundant and could therefore be included in the list of requirements for a facilitys safety program.