Text

Comment (194) of Marcus Nichol on Behalf of Nuclear Energy Institute on PR- 50, 52- Emergency Preparedness for Small Modular Reactors and Other New Technologies
	ML20267A326
Person / Time
Site:	Nuclear Energy Institute
Issue date:	09/22/2020
From:	Nichol M; Nuclear Energy Institute
To:	;
	SECY/RAS
References
	85FR28436, NRC-2015-0225, PR-50, PR-52, RIN 3150-AJ68
	Download: ML20267A326 (23)
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PUBLIC SUBMISSION As of: 9/23/20 11:19 AM Received: September 22, 2020 Status: Pending_Post Tracking No. kfe-2rlj-c5ff Comments Due: September 25, 2020 Submission Type: Web Docket: NRC-2015-0225 Emergency Preparedness Requirements for Small Modular Reactors and Other New Technologies Comment On: NRC-2015-0225-0171 Emergency Preparedness for Small Modular Reactors and Other New Technologies; Extension of Comment Period Document: NRC-2015-0225-DRAFT-0290 Comment on FR Doc # 2020-15731 Submitter Information Email: atb@nei.org Organization: Nuclear Energy Institute General Comment See attached file(s)

Attachments 09-22-20_NRC_Industry Comments on EP for SMRs and ONT Proposed Rule and DG-1350 Page 1 of 1 09/23/2020 https://www.fdms.gov/fdms/getcontent?objectId=090000648486f83b&format=xml&showorig=false PR-50, 52 85 FR 28436 194

MARCUS R. NICHOL Senior Director, New Reactors 1201 F Street, NW, Suite 1100 Washington, DC 20004 P: 202.739.8131 mrn@nei.org nei.org September 22, 2020 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTN: Rulemakings and Adjudications Staff

Subject:

NEI Comments on Proposed Rule, Emergency Preparedness for Small Modular Reactors and Other New Technologies, and Draft Regulatory Guide (DG), DG-1350, Performance-Based Emergency Preparedness for Small Modular Reactors, Non-Light-Water Reactors, and Non-power Production or Utilization Facilities [Docket ID NRC-2015-0225]

Project Number: 689

Dear Rulemaking and Adjudications Staff:

The Nuclear Energy Institute (NEI)1 and its members appreciate the opportunity to provide comments on the subject Proposed Rule and Draft Regulatory Guide. We continue to strongly support the efforts by the U.S. Nuclear Regulatory Commission (NRC) to create an alternative emergency preparedness framework for Small Modular Reactors (SMRs) and other new technologies (ONTs). Such a framework is necessary to recognize the technological advancements that are inherent in SMRs and ONTs.

Our detailed comments, which are included in the attachments to this letter, provide the industrys responses to NRCs questions in the proposed rule as well as recommendations to provide greater regulatory clarity. In addition to the attached comments, below we briefly discuss the NRC authority to undertake this rulemaking, and offer NEIs views on the suggestion made in comments submitted by the Federal Emergency Management Agency (FEMA) that additional congressional action may be necessary in order for the NRC to complete this rulemaking. As explained below, neither the since-expired 1980 legislation cited in FEMAs comment letter (or any subsequent legislation, for that matter), nor the controlling decisions of the U.S. Courts of Appeals addressing radiological emergency preparedness, support the proposition that further congressional action is necessary to finalize this rulemaking.

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.

Rulemaking and Adjudications Staff September 22, 2020 Page 2 NRC Authority to Undertake this Rulemaking The Atomic Energy Act (AEA) and Energy Reorganization Act of 1974 grant the NRC broad authority to regulate the use of radioactive materials. Although the NRC must comply with the Administrative Procedure Act and other relevant requirements in carrying out its mission, it is well established that the AEA's regulatory scheme is virtually unique in the degree to which broad responsibility is reposed in the [NRC],

free of close prescription in its charter as to how it shall proceed in achieving the statutory objective.2 Central to the agencys statutory mandate is the Commissions authority to specifically authorize and promulgate regulations necessary to protect health and to minimize danger to life or property.3 This proposed rulemaking fits squarely within the NRCs authority to promulgate requirements governing the licensing of commercial power reactors and other facilities via notice and comment rulemaking.

Under this broad statutory authority, the Commission is responsible for making final licensing and regulatory decisions regarding whether an applicant or licensee has provided reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. FEMA plays an important, consultative role in NRCs licensing and ongoing regulatory oversight of offsite radiological emergency planning. For example, FEMA findings regarding the adequacy of state and local plans establish a rebuttable presumption in NRC licensing proceedings.4 The proposed rulemaking does not suggest altering this consultative relationship in situations where specific, radiological offsite emergency preparedness planning is necessary - i.e., in situations where the plume exposure pathway Emergency Planning Zone (EPZ) extends beyond the site boundary.5 While we recognize the importance of the NRC-FEMA consultative relationship, Congress and the U.S. Courts of Appeals have long recognized that the NRC has the final word regarding whether a licensee or applicant has provided reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency. For example, Section 109 of the NRC Authorization Act for Fiscal Year 19806 - the legislation cited in FEMAs comments - authorizes funds appropriated for fiscal year 1980 to be used to issue operating licenses for utilization facilities only if: (1) the Commission, in consultation with FEMA, determines that an adequate state or local emergency plan exists, or (2) in the absence of such a plan, there exists a State, local, or utility plan which the Commission determines provides reasonable assurance that public health and safety is not endangered by operation of the facility concerned.7 Subsequently, the NRC Authorization Acts for fiscal years 1982-1983, and 1984-1985 reinforced that the NRC is ultimately responsible for making reasonable assurance findings, explicitly stating that the NRC may issue operating licenses in the absence of a State or local emergency preparedness plan which has been approved by [FEMA] if the NRC determines that there exists a State, local, or utility plan which provides reasonable assurance that public health and safety is not endangered by operation of the facility concerned.8 The U.S. Courts of Appeals have agreed that offsite radiological emergency planning falls 2 Siegel v. AEC, 400 F.2d 778, 783 (D.C. Cir. 1968).

3 42 U.S.C. 2201(i).

4 10 CFR § 50.47(a)(2); See also, 10 CFR § 50.54(s)(2)(ii), (3).

5 See, Emergency Preparedness for Small Modular Reactors and Other New Technologies: Proposed rule and guidance request for comment, 85 Fed. Reg. 28,436, 28,452, 28,460 (May 12, 2020)(Proposed Rule).

6 Authorization of Appropriations for Fiscal Year 1980, Pub. L. No 96-295 (1980 Authorization Act).

7 1980 Authorization Act, at section 109(a)(2).

8 Authorization of Appropriations, Pub. L. No.97-415, at section 5, Authority to Issue Licenses in Absence of Emergency Preparedness Plans (Jan. 4, 1983) (authorizing NRC appropriations for fiscal years 1982 and 1983); See also, Authorization of Appropriations for Fiscal Years 1984 and 1985, Pub. L. No.98-553, at section 108.

Rulemaking and Adjudications Staff September 22, 2020 Page 3 within the NRCs area of expertise, and that the NRC has the final word on the adequacy of a licensees radiological emergency preparedness efforts.9 The designation of the NRC as the agency with ultimate responsibility for establishing the radiological emergency preparedness requirements applicable to licensees and applicants - including the necessity for, and size of any required EPZ - is both appropriate and essential because it avoids unnecessary and inefficient dual regulation by multiple Federal agencies.

No Need for Congressional Action for NRC to Finalize this Rulemaking Given the discussion above, we respectfully disagree with FEMAs suggestion in its comments on the proposed rule that congressional action may be necessary for the NRC to finalize this rulemaking. Specifically, under the heading Initial Premises and Assumptions, FEMA states:

FEMA acknowledges NRC decisions on obtaining and maintaining operating licenses are based, in part, on a composite review of offsite emergency capabilities and those provided by the licensee within the plant. The NRC has the authority, utilizing FEMAs input, to determine the relative importance of offsite emergency preparedness in the licensing decision. Thus, we assume that adequate offsite emergency planning and preparedness are still considered essential to obtaining and maintaining an operating license. Also, FEMA believes community preparedness is a shared responsibility and a critical component of preparedness is the local communitys participation in identifying risk and building the appropriate capabilities to mitigate against the identified risk.

To the extent that the proposed rule alters these premises regarding the consultative relationship between the NRC and FEMA and the relative importance of offsite emergency planning and preparedness, FEMA believes any change in consultation requirements would involve a matter of significant public policy which may ultimately have to be resolved by Congress as was done in the passage of the NRC Authorization Act of 1980, Public Law 96-295.10 First, in our view, this proposed rulemaking does not seek to alter the premises regarding the consultative relationship between the NRC and FEMA. Rather, consistent with NRCs broad statutory authority, the proposed rule recognizes that the current emergency preparedness requirements and guidance were developed with a focus on large, light-water reactors and seeks to provide a framework for small modular reactors (SMR) and other nuclear technologies (ONT) that considers the advances in designs and safety research. The proposed rule puts forward a performance-based approach to emergency preparedness for SMRs and ONT, which includes the possibility that an SMR or ONTs plume exposure EPZ may not extend beyond the site boundary. Offsite emergency planning for such facilities would not be required by the NRC.11 9 See, e.g., Mass v. US NRC, 856 F.2d 378, 383 (1st Cir. 1988) (finding that offsite emergency planning falls within the NRCs area of expertise and that NRC is specifically authorized and directed to determine whether emergency plans adequately protect the public.); Mass v. US NRC, 878 F.2d 1516, 1524 (1st Cir. 1989)(upheld NRCs decision to allow restart of the Pilgrim nuclear power plant, despite a FEMA finding that the licensees emergency preparedness plans were inadequate and concluding that although the NRC must base its ultimate finding on a review of FEMAs findings and determinations, it need not give those findings conclusive weight.; State of Ohio ex rel. Celebrezze v. US NRC, 868 F.2d 810, 813 (6th Cir.1989)(The responsibility for evaluating and approving the plans is shared between [FEMA] and the NRC... but final decision-making authority on a plans adequacy rests with the NRC.).

10 FEMA Comments: Nuclear Regulatory Commission 10 CFR Parts 50 and 52, [NRC-2015-0225] RIN 3150-AJ68 Emergency Preparedness for Small Modular Reactors and Other New Technologies, Federal Register Notice, dated 12 May 2020, July 20, 2020 (FEMA Comments), at pg. 2.

11 See Proposed Rule, at pgs. 28,448, 28,452.

Rulemaking and Adjudications Staff September 22, 2020 Page 4 But for facilities where the plume exposure EPZ extends beyond the site boundary - i.e., SMR and ONT facilities requiring specific, offsite radiological emergency preparedness planning - the current NRC/FEMA consultation process would remain unchanged. The proposed rule also makes clear that [t]he NRCs proposal not to require offsite planning activities for facilities with plume exposure pathway EPZs at the site boundary does not affect FEMAs responsibility for overall emergency management and providing assistance to State and local response organizations.12 Nor does it affect the responsibility of State and local governments to establish and maintain comprehensive emergency management plans.13 Further, neither the early NRC authorization legislation discussed above, nor the decisions of the U.S. Courts of Appeals in this area, support the notion that this rulemaking involve[s] a matter of significant public policy which may ultimately have to be resolved by Congress.14 Although FEMA seems to rely upon the 1980 Authorization Act to support this proposition, that narrowly-tailored legislation does not - 40 years later - constrain the NRCs ability to engage in this rulemaking using its current appropriated funds. In fact, on its face, the 1980 Authorization Act authorizes funds to be appropriated for the fiscal year 1980.15 This specific authorization further conditions the use of any fiscal-year-1980 funds authorized to be appropriated on the Commission making certain findings regarding State, local, or utility emergency preparedness plans -

either in consultation with FEMA or on its own.16 Fiscal Year 1980 funds were appropriated to the NRC both before and after enactment of the 1980 Authorization Act.17 There is no indication in the 1980 Authorization Act itself, or either of the relevant Appropriations Acts, that the restrictions provided in the 1980 Authorization Act were intended to survive the NRCs use of funds appropriated for the 1980 fiscal year.18 Indeed, as noted below, at least one federal court has described the 1980 Authorization Act as expired. And absent explicit language to the contrary, there is a strong presumption against construing substantive provisos or general provisions in annual appropriations as permanent legislation.19 Contrary to the suggestion in the FEMA comments, the early NRC Authorization Acts provide insight into Congress intent when it authorized the funds to create the current emergency preparedness regulatory framework. In our view, that intent was clear: Congress directed that NRC consult with FEMA on the adequacy of offsite emergency preparedness in the licensing and regulation of utilization facilities in situations where offsite emergency planning was necessary. However, Congress left the ultimate 12 Proposed Rule, at pg. 28,449.

13 Id.

14 FEMA Comments, at pg. 2.

15 1980 Authorization Act, at Sec.101(a).

16 Id.

17 See Energy and Water Development Appropriation Act, 1980, Pub. L. 96-69, Title IV - Independent Agencies (Sept. 25, 1979) (1980 Appropriations Act); Supplemental Appropriations and Rescission Act, 1980, Pub. L.96-304, Title I -

Independent Agencies (July 8, 1980) (1980 Supplemental Appropriations Act).

18 Both the 1980 Appropriations Act and the 1980 Supplemental Appropriations Act appropriate funds to the NRC for the Fiscal Year 1980 to remain available until expended. The 1980 Authorization Act conditions use of funds authorized to be appropriated for Fiscal Year 1980. While the no year approach to funding means that all of the funds appropriated for Fiscal Year 1980 were not required to be utilized in that fiscal year, there is no indication that the restrictions in the 1980 Authorization Act were intended to survive exhaustion of those funds.

19 See, e.g., Principles of Federal Appropriations Law: Chapter 2 The Legal Framework, United States General Accountability Office (Fourth Ed., 2016 Revision) (Since an appropriation act is made for a particular fiscal year, the starting presumption is that everything contained in the act is effective only for the fiscal year covered. Thus, the rule is: A provision contained in an annual appropriation act is not to be construed to be permanent legislation unless the language used therein or the nature of the provision makes it clear that Congress intended it to be permanent.). Id. at pg. 2-86.

Rulemaking and Adjudications Staff September 22, 2020 Page 5 responsibility for making decisions regarding the adequacy of both on-site and offsite radiological emergency planning squarely with the Commission. In fact, the D.C. Circuit specifically held in 1991 that the 1980 Authorization Act, an expired fiscal appropriations law,... did not limit the licensing discretion otherwise conferred on the Commission by Congress.20 The court further concluded that Congress left to the NRC's discretion the specific requirements of emergency planning, including the authority to develop generic standards that would reasonably assure the public safety without having to examine the specific safety consequences of each emergency plan for each plant.21 Finally, this proposed rulemaking is consistent with the Congressional expectations embodied in the Nuclear Energy Innovation and Modernization Act (NEIMA), as enacted on January 14, 2019. Specifically, in NEIMA, Congress directed the NRC to establish a risk-informed, technology-inclusive framework to license and oversee advanced nuclear technologies. In doing so, it specifically identified emergency preparedness as an area to be addressed by the NRC.22 Thus, if any congressional direction were required for the NRC to pursue this issue (and it is not), it seems that Congress provided that direction in Section 103 of the NEIMA.

If you have questions concerning our comments, please contact me or David Young (202-739-8127 or dly@nei.org).

Sincerely, Marcus Nichol Attachments c:

Ms. Kathryn Brock, NSIR/DPR, NRC Mr. Mohamed K. Shams, NRR/DANU, NRC 20 Massachusetts v. NRC, 924 F.2d 311, 324 (D.C. Cir. 1991) (emphasis added).

21 Id. at 326.

22 Nuclear Energy Innovation and Modernization Act, Pub. L. 115-439, at Sec. 103 Advanced Nuclear Reactor Program (Jan. 14, 2019).

Response to Questions in Section IV, Specific Requests for Comments Page 1 The NRC is seeking public comment on this proposed rule. The NRC staff is particularly interested in comments and supporting rationale from the public on the following:

1. Terminology used to describe the requirements: This proposed rule continues the practice from SECY-11-0152, Development of an Emergency Planning and Preparedness Framework for Small Modular Reactors, of describing the alternative framework for EP as technology-neutral, dose-based, and consequence-oriented. The NRC recognizes, however, that the overarching term risk-informed as defined by the Commission in STAFF REQUIREMENTS -

SECY-98-144 - White Paper on Risk-Informed and Performance-Based Regulation (ADAMS Accession No. ML003753601), includes consideration of both the likelihood of a spectrum of events and their consequences. In the context of EP, the consequences of concern would be dose. The NRC is therefore considering aligning the discussion of the EP framework in this rule with its other risk-informed, performance-based regulations and considering eliminating the use of the descriptors dose-based and consequence-oriented, but intends no change to the meaning of the proposed regulations. Would such a change impact the clarity and predictability of the regulations?

Response: We believe this change would be beneficial as it would promote consistency in the understanding and implementation of NRC regulations. The clarity and predictability of the proposed EP regulations would not be impacted provided the final rule acknowledges this alignment within the discussion of the EP framework, and that previously used terms such as dose-based and consequence-oriented are subsumed within new terminology or concept descriptions.

2. Scope of this proposed rule: This proposed rule would allow SMRs and ONTs to establish an alternative performance-based, consequence-oriented approach to EP. The NRC received a comment on its draft regulatory basis in 2017 that recommended that the NRC expand the scope of this proposed rule to include large LWRs. Large LWRs were not included by the NRC in the scope of this proposed rule because an EP licensing framework already exists for those reactors, and licensees for those plants have not presented a clear interest in changing that framework. Nonetheless, in light of the public comment on the draft regulatory basis, and although this proposed rule is written for SMRs and ONTs, the NRC is open to considering a performance-based, consequence-oriented approach to EP for large LWRs, fuel cycle facilities, and currently operating NPUFs.

a. Are the proposed non-light-water reactor, non-power production or utilization facility, and small modular reactor definitions in § 50.2 sufficient to address EP for existing and anticipated technologies? Are there any unintended consequences of including each of these classes of facilities within the scope of this proposed rule? Please provide the basis for your response.

Response to Questions in Section IV, Specific Requests for Comments Page 2 Response: The final rule should clearly state that a small modular reactor may have a licensed thermal power up to 1,000 MWt, and that the limit applies to each module in a facility and not to the total thermal power of all modules in a facility. For example, on page 83, the proposed definition of Small Modular Reactor in 10 CFR 50.2 should be clarified to read, Small modular reactor means a power reactor, licensed under § 50.21 or § 50.22 to produce heat energy up to 1,000 megawatts-thermal per module, which may be of modular design as defined in § 52.1 of this chapter. [Emphasis added to identify proposed change.] We have not identified any unintended consequences of including each of these classes of facilities within the scope of this proposed rule.

b. Should the NRC consider a performance-based, consequence-oriented approach to EP for entities besides SMRs and ONTs (e.g., large LWRs, fuel cycle facilities, and currently operating NPUFs) in a future rulemaking? Please provide a basis for your response.

Response: NEI appreciates the NRC staff exploring opportunities to apply a performance-based, consequence-oriented approach to EP for entities besides SMRs and ONTs. More broadly, we support the application of performance-based, consequence-oriented approaches to regulatory oversight of nuclear technologies. NEI has no objection to the NRC considering this approach for large LWRs; however, if pursued, it should be a low priority rulemaking. The benefit from this approach would be mostly limited to new facilities in green field locations (i.e., not collocated with an existing operating reactor).

Given current interest in building these types of facilities, there is no pressing need for a performance-based, consequence-oriented approach to EP for large LWRs.

c. If the NRC considers a performance-based, consequence-oriented approach to EP for entities other than SMRs and ONTs, what criteria should such entities be required to meet to use a performance-based, consequence-oriented approach to EP in a future rulemaking? Please provide a basis for your response.

Response: Without foreclosing on the possibility of making comments during a future rulemaking, the criteria proposed in DG-1350 seems appropriate for other entities seeking to use a performance-based, consequence-oriented approach to EP.

d. If the NRC does not consider a performance-based, consequence-oriented approach to EP for entities other than SMRs and ONTs, should the NRC offer mechanisms (other than the existing exemption process) that would allow other entities to request NRC approval to use the EP framework proposed in this rulemaking? If so, what mechanisms? Please provide a basis for your response.

Response: NRC regulations could be changed to allow applicants the flexibility to choose the existing deterministic EP framework or the proposed performance-based, Response to Questions in Section IV, Specific Requests for Comments Page 3 consequence-oriented framework, AND, under either framework, the option to determine an appropriate, site-specific EPZ size through an analysis.

3. Performance-based requirements: Under this proposed rule, applicants and licensees choosing to comply with the performance-based approach would need to demonstrate emergency response functions required under § 50.160(b)(1)(iii) through the use of drills or exercises and performance objectives. Are there additional emergency response functions that the NRC should consider for incorporation in this proposed rulemaking? Please provide the basis for your answer.

Response: There are no additional emergency response functions that warrant NRC consideration for incorporation in the proposed rulemaking.

With respect to the staffs evaluation of an applicants proposal for meeting the performance-based requirements, we noted this paragraph in DG-1350:

The NRC will review each application to determine that the applicant describes how the performance-based framework in 10 CFR 50.160 will be met. The staff will evaluate applications using a graded approach based on site-specific consequence analyses. Program elements that may be implemented and evaluated according to a graded approach include periodicity between inspections, drills, exercises, number of performance objectives, and staffing.

We believe this is an extremely important description of how the NRC staff will approach their reviews of applications. For this reason, we recommend that this paragraph, or essentially the same content, be included in the final rule (i.e., as statements of consideration).

The proposed rule currently focuses on drills as the primary method to demonstrate maintenance of effective response capabilities. As the most common means of demonstrating response capabilities, drills should certainly be one means of achieving compliance with the rules performance-based requirements. However, as new technologies are developed and mature, the NRCs performance-based EP framework should be able to accommodate other methods for demonstrating response capabilities. For example, some advanced reactor designs may not rely on human action to perform one or more emergency plan functions. Further, a design could have a safety and accident profile that obviates the need for certain emergency response capabilities identified in DG-1350.

4. Drills or exercises: Under proposed § 50.160(b)(1), applicants and licensees would need to develop a drill and exercise program to demonstrate compliance with performance-based requirements. Would an 8-year exercise cycle (as is currently required for large LWRs) be Response to Questions in Section IV, Specific Requests for Comments Page 4 appropriate for SMRs or ONTs choosing to comply with the performance-based approach? If not, would an alternative cycle length be appropriate? Please provide the basis for your answer.

Response: An 8-year exercise cycle would be appropriate for SMRs or ONTs, and aligned with the cycle length applicable to large LWRs.

5. Planning activities: The NRC is proposing four planning activities under § 50.160(b)(1)(iv)(A) that all applicants and licensees choosing the performance-based approach to EP would need to comply with and 11 offsite planning activities under § 50.160(b)(1)(iv)(B) that are designed for applicants and licensees with an EPZ that extends beyond the site boundary.

These planning activities identify certain EP-related activities that are not readily observable and cannot be effectively measured through drills and exercises. Are there any planning activities that should be added to or removed from the NRCs proposed list? Please provide the basis for your answer.

Response: NEI has no recommended changes to the NRCs proposed list of planning activities. With respect to an emergency facility required by proposed

§ 50.160(b)(1)(iv)(A)(4), the guidance in the final regulatory guide should clarify that the facility may be collocated with a facility serving another purpose (i.e., it need not be a dedicated facility). This comment also applies to the offsite facility and any backup facilities required by § 50.160(b)(1)(iv)(B)(6).

6. Hazard analysis for contiguous or nearby facilities: The NRC is proposing to require applicants and licensees choosing a performance-based approach to EP to submit a hazard analysis under § 50.160(b)(2).

a. To what extent should this analysis be harmonized with or rely upon the analysis conducted under 10 CFR 100.20, Factors to be considered when evaluating sites, for man-related hazards?

Response: There are two relevant analysis requirements found in 10 CFR 100, Reactor Site Criteria.

1) 10 CFR 100.20, Factors to be considered when evaluating sites, which states that The Commission will take the following factors into consideration in determining the acceptability of a site for a stationary power reactor:... The nature and proximity of manrelated hazards (e.g., airports, dams, transportation routes, military and chemical facilities) must be evaluated to establish site characteristics for use in determining whether a plant design can accommodate commonly occurring hazards, and whether the risk of other hazards is very low.

Response to Questions in Section IV, Specific Requests for Comments Page 5

2) 10 CFR 100.21, Non-seismic siting criteria, which states that the Applications for site approval for commercial power reactors shall demonstrate that the proposed site meets the following criteria:... Potential hazards associated with nearby transportation routes, industrial and military facilities must be evaluated and site characteristics established such that potential hazards from such routes and facilities will pose no undue risk to the type of facility proposed to be located at the site.

An applicant should be able to rely upon (reference) applicable portions of a Part 100 hazard analysis to support an analysis required by § 50.160(b)(2). In addition, the NRC staff should be aware that the draft guidance under development for the in-progress rulemaking for Alternative Physical Security Requirements for Advanced Reactors will likely include a hazard analysis focused on assessing impacts to security-related design features.

b. What kinds of facilities might be located contiguous or nearby to SMRs or ONTs?

Response: Refer to International Atomic Energy Agency (IAEA) webpage, Non-electric applications, and World Nuclear Organization webpage, Nuclear Process Heat for Industry. These webpages contain information and links to other sources describing applications that could involve a contiguous or nearby facility.

c. Should the NRC change the scope of the hazard analysis? If so, how should the scope of the hazard analysis change? Please provide the basis for your answer.

Response: The new framework should give an applicant flexibility when determining which hazards will be assessed as part of the licensing process and which may be assessed later. This comment refers specifically to hazards that will not be present until sometime after initial licensing is completed. For example, a power reactor facility ultimately able to accommodate six modules may be initially licensed with two modules in operation. In this case, the applicants initial hazard analysis may assess the hazard from the second module (i.e., a contiguous facility) or any number of modules up to six.

If the hazards analysis did not initially address all six modules, then analysis updates could be performed and submitted (e.g., through a license amendment request or other licensing action) as other modules were added. Similarly, if a dual-purpose facility were constructed to generate both electricity and process heat, and the process heat taker facility (i.e., a nearby facility) will be added sometime after the nuclear facility begins generating electricity, then the applicants initial hazard analysis may or may not include the process heat taker facility. If not, the licensee would later need to perform and submit an updated hazard analysis reflecting the process heat taker facility.

Response to Questions in Section IV, Specific Requests for Comments Page 6

7. Emergency planning zones: The NRC is proposing to require applicants and licensees choosing to comply with proposed § 50.160 to submit the analysis used to establish a site-specific plume exposure pathway EPZ size. The analysis for the proposed EPZ size would be reviewed on a case-specific basis by the NRC to ensure that design-and site-specific accident scenarios are appropriately incorporated and that reasonable assurance is maintained with the proposed EPZ size. Applicants and licensees would need to establish their plume exposure pathway EPZ as the area within which public dose is projected to exceed 10 mSv (1 rem) TEDE over 96 hours0.00111 days 0.0267 hours 1.587302e-4 weeks 3.6528e-5 months from the release of radioactive materials resulting from a spectrum of credible accidents for the facility.

a. Is the proposed 10 mSv (1 rem) criterion appropriate?

Response: Yes. The proposed 10 mSv criterion is aligned with the criterion applicable to emergency planning assessments for large LWRs. The staff should also consider a criterion that accounts for a substantial reduction in early severe health effects. For example, the EPZ sizing methodology described in the NRC-approved Early Site Permit (ESP) for the Clinch River site contains a criterion that the conditional probability of acute dose exceeding a 200 rem whole body dose at distances outside of the plume exposure pathway EPZ from more severe accident scenarios is less than 1 x 10-3 per reactor-year. The NRC found this criterion acceptable because it is similar to the criterion used to evaluate consequences of very severe accidents (e.g., less probable core damage accidents that release very large quantities of radioactive material to the atmosphere) in NUREG-0396, and based upon the same reasoning that was used as the technical basis for the plume exposure pathway EPZ distance, as codified in NRC regulations.

b. Are there particular factors and technical considerations that need to be included in an EPZ size analysis?

Response: Yes. Accident scenario frequency/probability should be considered and appropriate cutoff criteria identified to remove extremely rare events and sequences from the sizing analysis. In addition, the timing of a radiological release and exceedance of 10 mSv (1 rem) TEDE over 96 hours0.00111 days 0.0267 hours 1.587302e-4 weeks 3.6528e-5 months should also be considered. For example, it may be possible to screen out releases occurring late in an accident sequence because Offsite Response Organizations (OROs) would already have taken actions under comprehensive (all hazards) emergency management plans to protect the health and safety of the public. Such actions could be initiated based on licensee communication of slowly degrading plant and radiological conditions. We note that the points of this comment are partially addressed in certain paragraphs contained in DG-1350 (e.g., A-1.b on page A-1 and B-3 on page B-1) but, given the importance of the topic, we encourage the staff to include a full discussion in the final rule (i.e., as statements of consideration).

Response to Questions in Section IV, Specific Requests for Comments Page 7 The final rule guidance should also address offsite EP program considerations when a facility is sited within a large land area owned by a Federal or State-level entity and subject to access controls. For example, consider a facility with a 1-mile radius owner-controlled area (i.e., licensee-controlled land) and an EPZ size determined to be a 2-mile radius. If this facility is located on a military base or national laboratory reservation, and the public does not have unrestricted access to areas within the 2-mile radius, then the facility should be able to adjust (scale) offsite EP requirements based on direction from the military or national laboratory. This direction could be documented in a Memorandum of Understanding between the licensee and the Federal or State entity.

c. If the analysis demonstrates that the EPZ is within the facilitys site boundary, would the need for a dedicated, Federal-mandated offsite radiological emergency preparedness program exist?

Response: No; in this case, there would be no technical basis for requiring an offsite radiological emergency preparedness program. The EPZ sizing requirements described in the proposed rule reflect the NRCs Principles of Good Regulation in that they are based on the best available knowledge from research and operational experience. NEI believes that absent a regulatory requirement, offsite planning will be accomplished on a cooperative basis between State and local agencies and the facility owner. This is the same approach used for other industrial facilities and would involve use of the extensive planning, preparedness and response guidance developed by the U.S. Department of Homeland Security and its agencies. Under this paradigm, agreements related to offsite planning and associated funding would likely be struck during facility siting discussions with State and local officials (similar to talks involving impact fees, taxes, local resource usage, etc.).

d. If the applicant or licensee provides an adequate description of the existing Federal, Tribal, State, and local Federal capabilities to interdict contaminated food and water, would the need for an IPZ exist? Please provide the basis for your answer.

Response: No. As discussed in the proposed rule, there are many Federal, Regional and State resources (e.g., agencies, laboratories, agreements and guidance, public notification methods, etc.) available to monitor food and water sources, and implement interdiction actions as needed. These resources are more numerous and have greater capabilities than existed in 1980, when the current IPZ requirement was implemented, and provide a reasonable basis for the approach described in the proposed rule. Also, with respect to classes of licensees outside of power reactors, we note that the NRC does not require an IPZ for facilities that do not have an offsite plume exposure pathway EPZ. Therefore, consideration should be given to removing the IPZ capability description Response to Questions in Section IV, Specific Requests for Comments Page 8 requirement for power reactor facilities that have justified an EPZ limited to onsite areas (i.e., the EPZ does not encompass offsite areas).

8. Costs: The NRC recognizes that all power reactor applicants will develop a PRA to meet existing requirements and support development of their application. The NRC would allow applicants the option to further the use of PRA to support a risk-informed approach for the development of source terms. The NRC is seeking information on the incremental cost estimates for any additional PRA modeling necessary to generate the credible accident sequences and the development of the source terms used in determining a site-specific EPZ size.

Response: An EPZ sizing analysis would be based on credible accident sequences greater than some cutoff criteria (per the response to question 7.b above) and leading to the largest offsite consequences (i.e., large accident source terms with a release to the environment).

These sequences will be a subset of all credible accident sequences identified and analyzed in accordance with other NRC requirements. For this response, we assume that the applicant possesses an acceptable level 1 PRA model, and the severe accident (e.g., MELCOR or MAAP) and consequence (e.g., MACCS) models necessary to support their application. In this case, the incremental cost would be to identify credible accident sequences for the EPZ sizing analysis and then calculate the source terms and offsite doses. The final cost would be primarily dependent on the number of sequences determined to be credible and potentially bounding for an EPZ analysis. Assuming there are four such candidate sequences, we estimate the total cost to be $100,000. The incremental cost could also vary based on the complexity of the design, with the cost for simpler designs being less. The additional cost for NRC review of a sizing analysis was not captured as the staff can provide a reasonable estimate.

Response to Questions in Section IX, Cumulative Effects of Regulation Page 1 In addition to the questions on the implementation of this proposed rule presented in the Specific Requests for Comments section of this document, the NRC is requesting CER feedback on the following questions:

1. In light of any current or projected CER challenges, does this proposed rule's effective date provide sufficient time to implement the new alternative proposed requirements, including changes to programs, procedures, and facilities?

Response: It is anticipated that some applicants will be seeking exemptions from, or employing alternative methods to meet, existing NRC EP requirements. The final rule should provide clarity with regard to the processing of applications submitted before the rulemaking is complete, and address the integration of approved alternate methods and exemptions with the requirements of the final rule. The final rule should also recognize that existing applicants, entities with applications in progress prior to the final rule effective date, will adhere to their committed compliance dates established through a licensing process (e.g.,

Part 50 or Part 52) since these dates may be different from those specified in the final rule.

2. If CER challenges currently exist or are expected, what should be done to address them? For example, if more time is required for implementation of the new alternative requirements, what period of time is sufficient?

Response: See response to Question #1, above.

3. Do other (NRC or other agency) regulatory actions (e.g., orders, generic communications, license amendment requests, inspection findings of a generic nature) influence the implementation of this proposed rule's requirements?

Response: Yes; for sites that require an EPZ encompassing areas outside the Owner Controlled Area, implementation of the proposed performance-based, consequence-oriented EP framework will be influenced by the requirements and guidance established by the Federal Emergency Management Agency (FEMA). In addition, the Protective Action Guides referenced in the proposed rule are issued by the Environmental Protection Agency (EPA).

4. Are there unintended consequences? Does this proposed rule create conditions that would be contrary to this proposed rule's purpose and objectives? If so, what are the unintended consequences, and how should they be addressed?

Response: We have not identified any unintended consequences from the proposed rule.

Response to Questions in Section IX, Cumulative Effects of Regulation Page 2

5. Please comment on the NRC's cost and benefit estimates in the draft regulatory analysis that supports this proposed rule. The draft regulatory analysis is available as indicated under the Availability of Documents section of this document.

Response: The benefit estimate should recognize the avoided cost of an offsite EP program that would be required by existing regulations but not under the proposed regulations. We estimate an initial cost of $15M to establish the program and $3M per year in recurring cost to maintain it; these amounts are in 2020 dollars. Over an assumed 40-year life of a plant, this amounts to an avoided cost of approximately $135M.

Response to Questions in Section XII, Paperwork Reduction Act Page 1 The NRC is seeking public comment on the potential impact of the information collection(s) contained in this proposed rule and on the following issues:

1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?

Response: Yes; the proposed information collection is necessary and will have practical value. The NRC has the authority to set onsite and offsite emergency preparedness (EP) requirements for power reactor facilities and non-power production or utilization facilities.

The information collection described in the rule will allow the NRC to evaluate a facility applicants proposal for a risk-informed and performance-based EP program. For many applicants, this option will be an improvement over the existing deterministic EP requirements in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities.

Subsequent information collection (i.e., after a license has been issued) will enable NRC inspection of a licensees EP program elements to ensure that reasonable assurance of adequate public protection is maintained.

2. Is the estimate of the burden of the proposed information collection accurate?

Response: No response.

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

Response: No response.

4. How can the burden of the proposed information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?

Response: No opportunities for minimizing the burden of the proposed information collection were identified. The NRC provides several avenues for electronic transmission and submittal of documents, including the Electronic Information Exchange (EIE) process, which is available from the NRC's Electronic Submittals webpage; by Optical Storage Media (OSM)

(e.g. CD-ROM, DVD); by facsimile; or by email. In addition, there is an existing capability to send performance indicator data to the NRC electronically (as part of the Reactor Oversight Process). It is likely that approximately 100 percent of the potential responses will be filed electronically.

Other Comments Page 1 Cmt Affected Section Comment/Basis Recommendation

1.

FRN page 28446, Col 1, second paragraph FRN page 28447, Col 1, last paragraph DG-1350, C.5.b The proposed 50.160(b)(1)(iii) elements overlap with and may become confused with the scope of the existing EP ROP performance indicators (PIs):

Drill/Exercise performance (DEP)

Emergency Response Organization Drill Participation (ERO)

Alert and Notification System Reliability (ANS) https://

www.nrc.gov/reactors/operating/oversight.html Basis:

Page 28446, Col 1, second paragraph - The performance-based requirements in proposed 50.160(b)(1)(iii) address the most risk-significant aspects of EP (), as well as several planning activities Page 28447, Col 1, last paragraph - Under proposed 50.160(b)(1) (iii) would need to have sufficient capability to demonstrate the following emergency response functions: which include ROP elements along with communications, command & control, staffing & operations, radiological assessment, and reentry.

DG-1350, C.5.b metric development descriptions The metrics methodology of DG-1350, C.5.b closely aligns with the ROP EP PI methodology (% successful performance, averaging over 8 quarters, etc.) increasing the chance of misinterpretation that the 50.160(b)(1)(iii) performance functions are part of the ROP process. Clarify in the FRN and DG-1350 that the elements of proposed 50.160(b)(1)(iii) are not part of the ROP process, including ROP reporting, but are instead records maintained for review by NRC staff during routine inspections.

The activities listed in 50.160(b)(1)(iii) are potential drill and exercise demonstration objectives. Not all objectives are included in each drill or exercise, but are scheduled to ensure that all objectives are demonstrated over the 8-year drill and exercise cycle.

Drill and exercise reports would be available for NRC inspection and would contain which objectives were credited, the performance standards to which they were judged, and the determination of whether they were successfully demonstrated during the drill or exercise.

2.

Page 28448, Col 3, Evacuation Time Estimate An ETE study is required as part of the planning function although limited offsite evacuation may be anticipated based on design-specific offsite accident doses. Current guidance (NUREG/CR-Clarify the requirement for evacuation planning to clearly limit the scope of the ETE to the site-specific EPZ.

Imposition of a requirement for an ETE study based on a 10-mile radius on reactors with significantly smaller EPZs Other Comments Page 2 Cmt Affected Section Comment/Basis Recommendation (ETE) study DG-1350, C.7(e) 7002) is based on an evacuation of a 10-mile EPZ set for large LWRs whereas the SMR/ONT EPZ may extend only marginally beyond the site boundary. For sites with an EPZ beyond the site boundary, but substantially different than 10 miles, it is unclear if the ETE requirement is limited to the actual EPZ or 10 miles.

is an excessive and unnecessary burden. DG-1350 section C.7(e) should be revised accordingly.

3.

DG-1350, C.5.c(3)

DG-1350, Table 1 DG-1350, C.5.c(3), requires the emergency classification scheme and the associated emergency action levels (EALs), as applicable for the design of the facility. Table 1 provides an example outline of potential EALs which includes elements that may not be applicable to certain reactor designs, such as a containment barrier.

The federal register acknowledges that some designs may employ a non-traditional containment approach which would conflict with the containment barrier EAL example in Table 1. Ensure that the example is viewed as just one possible scheme and that the reactor design specifics are the final determination of the actual EAL structure and content.

4.

DG-1350, C.5.c(3)

DG-1350, C.5.c(3), requires an emergency classification scheme and the associated emergency action levels (EALs) as applicable for the design of the facility but provides no endorsement or guidance on use of existing industry EAL guidance.

DG-1350 should include a statement similar to Should elements of existing NRC-endorsed EAL guidance be applicable to the SMR/ONT design, these elements may be used in the development of the site-specific EALs.

5.

DG-1350, Table 1, Sample EAL Description For the area of Abnormal Radiological Conditions, the Initiating Condition of High radiological effluents has five associated Emergency Action Levels (EALs) that are tied to types of radiation monitors. Some monitors meeting these generic descriptions would be considered in-plant monitors and not effluent monitors. For example, there are radiation monitors for in-plant areas and processes that are upstream of potential radiological release points The guidance should be clear that the radiation monitors to be included in EALs are only those associated with detecting and monitoring a radiological release (i.e., high radiological effluent) from the facility. Radiation monitors for areas and processes internal to the facility and upstream of monitored release (effluent) points need not be included unless the applicant wishes to credit them as alternative methods to detect and monitor a release in the event an effluent monitor is unavailable.

Other Comments Page 3 Cmt Affected Section Comment/Basis Recommendation (i.e., where a release becomes an effluent from the facility).

6.

DG-1350, C.5.d(1) and d(2)

These sentences appear to have redundant elements (e.g., determining protective actions). In addition, the expected scope of protective actions is unclear - onsite only or onsite and offsite.

Revise C.5.d to remove redundant content and clearly state the expected scope of the protective actions.

7.

DG-1350, C.5.h(4)

The title Releases may be misleading.

Revise the title to Releases to the Environment to clarify that a leak into containment or into another interfacing system is not in the intended scope.

8.

DG-1350, C.5.i(1)

Reentry after hostile action-based events should be primarily addressed in the security plan if no radiological conditions are present.

Consider revising item i(1) to read access to the facility after radiological emergencies including the methods Consider adding an item i(3) which reads if applicable, capability to develop and implement coordinated reentry plans after hostile action-based emergencies including The reentry would be coordinated with site security and/or offsite supporting organizations. This would be consistent with item C.6.b(7).

9.

DG-1350, C.5.g(2)(a)

Bullet number 2 (Evaluated Exercises) should be moved to a new section since exercises are not drills in the sense they are not used for training and instruction.

Delete bullet 2 and replace with new section C.5.g(3) which reads, Evaluated exercises are used to demonstrate proficiency in the major portions of the emergency plan and, as such, cannot be used for training and instruction. Participation in an evaluated exercise is not required in advance of being assigned to an emergency response role.

10.

DG-1350, C.5.g(2)(a)

The note following the bullets in C.5.g(2)(a) seems to be missing format.

Editorial suggestion: Make the note regarding free play a new section C.5.g(2)(b).

Other Comments Page 4 Cmt Affected Section Comment/Basis Recommendation

11.

Page 28453, Col 2 -bullet 3

- Emergency Planning Zones ML18114A176 The NRC has asked for comments on technical considerations applicable to the EPZ sizing analysis.

Meteorological conditions may be highly variable which in turn affects the exposure at a given location on the site boundary. Highly conservative assumptions (e.g., constant wind direction with 95th percentile worst case wind speed and stability class conditions persisting throughout the 96-hour analysis period) provide the maximum possible dose but do not provide a realistic view of the true risks to the public at the site boundary.

Background documents (See ML18114A176, Section 2.4, Meteorological Data Development) already acknowledge that the selection of meteorological data would include evaluation of variability in wind speeds, atmospheric stability, precipitation, mixing height, etc. but not directional variation.

Allowances for normal diurnal variability in the wind direction during the 96-hour analysis period should be considered to more accurately represent actual exposure risk to an individual at the site boundary over a 96-hour period. The current methods typically assume a constant wind direction for the entire duration which will over-estimate the individuals exposure and risk by continuing to accumulate dose when the wind direction changes and the individual is not down wind of the release.

If sufficient wind direction variability is supported by local meteorological data, a realistic yet moderately conservative direction distribution over the 96-hour period should be considered to develop compass point-based sector exposure estimates.

To improve regulatory consistency, the NRC should add an appendix to DG-1350 which discusses the situations in which meteorological variability affects conservatism.

12.

DG-1350, Section C Staff Regulatory

Guidance, Item C.8 The guidance here should address expectations for the identification of common cause initiating events when analyzing site-specific hazards posed by multi-reactor modules/units. This topic is briefly addressed in Appendix B (item B-2).