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1Nuclear Law Committee, May 2017

May 2017Vol. 9, No. 2

Nuclear LawCommittee Newsletter

Continued on page 3.

NRC READINESS STRATEGY FOR NON-LWR LICENSING REVIEWSMaxine Segarnick

The U.S. Nuclear Regulatory Commission’s (NRC) licensing regulations are based on the design and operation of light water reactors (LWRs). In order for the United States to join other nations in the modern era of advanced reactor technology, particularly in emerging non-LWR technology, it is important for the NRC to adjust its regulatory framework to consider non-LWRs. As non-LRWs (including small modular reactors (SMRs) that use non-LWR technology) face unique technical challenges, the NRC is engaging with stakeholders and potential applicants as it analyzes the associated regulatory gaps with licensing such reactors. A continued effort to streamline the licensing process for these reactors is important, as non-LRWs have safety and efficiency advantages over the existing fleet of large LWRs. This article describes the NRC’s readiness strategy for conducting licensing reviews for non-LWR designs, as set forth in recent NRC publications, and also provides a case study on emergency planning requirements to illustrate potential regulatory improvements for non-LWR licensing.

Background

Despite having reviewed various conceptual non-LWR designs at different levels of detail, the NRC has never granted a construction or operating license for a non-LWR. While other nations

continue to develop non-LRW technologies, (e.g., China’s 210 megawatt electrical (MWe) high-temperature gas-cooled reactor (HTGR)), the NRC has minimal experience with licensing non-LRWs. Three U.S. non-LRWs were licensed by the Atomic Energy Commission prior to establishment of the NRC in 1975, with the last one having closed in 1989 (Fort St. Vrain, an HTGR).

The closest the NRC came to licensing a non-LWR was the Clinch River Breeder Reactor Plant, a liquid sodium-cooled fast-breeder demonstration reactor. In 1975, the NRC docketed the construction permit application for this non-LWR; but, by 1983, the applicant cancelled the project due to the congressional decision to deny additional project funding. The NRC has also conducted pre-application reviews of non-LWR designs, including, for example, the 1994 pre-application safety evaluation report for the Power Reactor Innovative Small Module (PRISM) liquid metal-cooled reactor.

Through these experiences, the NRC staff has performed pre-application design reviews and safety and environmental reviews, issued a safety evaluation report, and held public hearings. However, without the opportunity to complete the review process, the NRC staff did not gain significant non-LWR licensing review experience. It is this lack of institutional knowledge of non-

2 Nuclear Law Committee, May 2017

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Nuclear Law Committee NewsletterVol. 9, No. 2, May 2017Aaron Flyer, Editor

In this issue:

NRC Readiness Strategy for Non-LWR Licensing Reviews Maxine Segarnick...................................1

Beyond Nuclear v. U.S. Department of Energy: District Court Allows DOE Shipment of Liquid-Form Highly Enriched Uranium from Chalk River to Savannah River Aaron Flyer ..............................................6

The NRC Regulates Historic Radium ContaminationOlivia Mikula and Alana Wase .............8

Update: EPA Finalizes Protective Action Guide ManualN. Lindsay Simmons ..............................10


Continued from page 1.

LWR licensing, coupled with a regulatory system built around LWR technology, which sets the stage for the NRC’s current licensing readiness strategy.

January 2017: The NRC Vision and Strategy Report

On January 3, 2017, the NRC published its report, “Vision and Strategy for Safely Achieving Effective and Efficient Non-Light Water Reactor Mission Readiness” (Agency-wide Documents Access and Management System (ADAMS) accession no. ML16139A812). The report’s purpose is to “assure NRC readiness to efficiently and effectively conduct its mission” to regulate non-LWRs. In this context, “readiness” means “the elements needed to conduct the NRC’s regulatory operations to support its mission are in place and optimized.”

The report states that the NRC is “fully capable” of reviewing a non-LWR design for licensing if an applicant were to submit a design today. However, the report also acknowledges the potential inefficiencies if a non-LWR application were submitted under the existing regulatory framework. This existing framework, codified in 10 Code of Federal Regulations (C.F.R.) parts 50 and 52, reviews applications against criteria established for licensing LWRs (see, e.g., appendix A to part 50). These LWR-based criteria would require the NRC to license a non-LWR application through regulatory exemptions and design-specific reviews.

The report describes two phases to achieve its goals. Phase 1 includes the development of non-LWR strategic goals, objectives, and strategies, which are organized into near-term (0 to 5 years), mid-term (5 to 10 years), and long-term (more than 10 years) time frames. Phase 2 implements the vision and strategy through “implementation action plans,” as well as through budgeting activities and task execution. Both phases involve opportunities for public feedback.

The NRC plans to achieve its readiness goal by 2025, in order to align its activities with the Department of Energy’s (DOE) goal of having the NRC review at least two non-LWRs to prepare for construction in the early 2030s. Given the variety of non-LWR technology under development, the NRC will prioritize which technologies are likely to be ready soonest for regulatory review. To make this determination, the NRC will collaborate with industry stakeholders, as well as DOE and international organizations undertaking non-LWR activities.

February and March 2017: Draft Guidance for Non-LWRs

On February 2, 2017, the NRC issued a notice and request for public comment in the Federal Register on a draft regulatory guide, “Guidance for Developing Principle Design Criteria for Non-Light Water Reactors” (82 Fed. Reg. 9246). The purpose of the document is to provide guidance for non-LWR designers, applicants, and licensees on how the general design criteria (GDC) in appendix A of title 10 C.F.R. part 50 apply to non-LWR designs in general, as well as to two specific non-LWR design concepts (sodium-cooled fast reactors and modular high temperature gas-cooled reactors). Because the current GDC are based on LWR technology, non-LWR designers can use this guidance, when finalized, to develop the principal design criteria for their proposed facilities as required in a license application under part 50 or part 52. The comment period closes April 3, 2017, and the NRC plans to issue the final regulatory guide at the end of 2017.

Additionally, on March 13, 2017, the NRC issued a notice and request for public comment in the Federal Register on a preliminary draft guidance document on non-LWR reactor security design considerations (82 Fed. Reg. 12,511). The guidance will provide security design considerations for a designer to consider when developing a non-LWR facility design. The comment period closes on April 27, 2017.


Recent Legislative Action Concerning NRC Readiness

In 2012, the NRC provided Congress with a report on how the NRC will prepare to review anticipated commercial advanced reactors licensing applications. See “Report to Congress: Advanced Reactor Licensing” (ADAMS no. ML12153A014). Since that time, Congress has actively focused on stimulating advanced reactor readiness, without making changes to the NRC’s statutory authority. For example, from 2015 through 2016, the 114th Congress considered several iterations of a bill encouraging development of advanced nuclear technology (see, e.g., H.R. 4048 (Nov. 19, 2015); S. 2461 (Jan 21, 2016); S. 2795 (Apr. 13, 2016); H.R. 4979 (Apr. 18, 2016); H.R. 5879 (July 4, 2016)).

Members of Congress continue to drive NRC action in advanced reactor licensing. For example, in January 2017, Representative Robert E. Latta (R-OH) introduced H.R. 590, which would serve to promote advanced reactor licensing by requiring certain NRC actions (see also S. 97 (Jan 11, 2017); H.R. 431 (Jan. 11, 2017)). The bill would require the NRC to transmit to Congress a plan for developing “an efficient, risk-informed, technology-neutral framework for advanced reactor licensing.” This NRC plan would have to evaluate options for licensing advanced reactors under existing NRC regulations. And, more generally, the NRC would have to evaluate the legal, regulatory, and policy issues involved in developing a framework for advanced reactor licensing.

Interestingly, as it relates to non-LWRs, the NRC’s 2017 strategy report already lays out a plan for addressing many of the topics raised in H.R. 590. If the bill, which passed the House in January and on February 10 was referred to the Senate Committee on Environment and Public Works, becomes law, the agency’s existing plans may serve to address the legislation.

Case Study: Off-site Emergency Preparedness and Non-LWRs

A brief look at the off-site emergency preparedness (EP) regulations illustrates the impracticality of licensing non-LWR technology under existing licensing regulations. Understanding these challenges is crucial to identifying the appropriate regulatory response.

First, some history: starting in 1958, the NRC’s predecessor agency, the Atomic Energy Commission (AEC), required nuclear power plant licensees to address EP when siting a plant (10 C.F.R. 100). Specifically, the AEC required a licensee to establish various distances from a nuclear power plant for evacuation in the case of certain accidents (Id.). In 1978, the NRC and U.S. Environmental Protection Agency established a joint task force to develop specific EP requirements (see SECY-11-0152). The task force report considered various potential accidents for large LWRs, and recommended a 10-mile emergency planning zone (EPZ) for the plume pathway from an accident, and a 50-mile EPZ for ingestion exposure (Id.). These EPZs were health-based precautionary measures in the unlikely event of a severe nuclear reactor accident. In 1980, two years after the NRC and EPA report, the NRC codified the 10-mile and 50-mile EPZ (10 C.F.R. 50.47(c)(2)). For context, the Three Mile Island accident of 1979 served to stimulate the formation of the EP requirements.

Since 2010, the NRC recognized that EP is a key policy issue for SMR designers, particularly because SMRs, by design, have comparatively lower risk of off-site release from reactor accidents (SECY-10-0034). The regulatory incongruity ultimately restricts SMR licensing because the codified standard may be overly restrictive for this new technology. So, instead of the prescriptive 10-mile and 50-mile standards, the NRC is considering scalable alternatives based on risk analyses, cost-effectiveness, and technology limitations (see SECY-11-0152).


Instead of utilizing the case-by-case exemption provided for in the statute, the NRC staff recommended a revision to the EP requirements and guidance documents for SMRs through a rulemaking (Id.). The staff made this regulatory recommendation in May 2015 to the NRC commissioners via a policy issue notice from the executive director of operations (SECY-15-0077). The notice sought the commission’s approval of the staff’s recommendations to initiate a rulemaking to revise EP standards for both SMRs and non-LWRs, to allow for a scalable EPZ distance commensurate with the proposed reactor’s power level. This option would eliminate the potential for inefficient use of agency resources through repetitive exemption requests. On June 22, 2016, the commission approved the staff’s rulemaking plan (SRM-SECY-16-0069). In the interim, the commission directed the staff to continue to utilize exemptions until the rulemaking is complete. On April 13, 2017, the NRC publicly noticed its draft regulatory basis to support this rulemaking, and is requesting comments by June 27, 2017 (82 Fed. Reg. 17,768).

Conclusion

According to NRC Commissioner Stephen Burns, the future of non-LWR licensing is difficult to predict, but will likely require some form of

regulatory change to reflect consensus on the appropriate technical acceptance criteria for these designs. In his view, movement in this area also depends, in part, on whether and when these technologies gain traction, as well as on social acceptance of the regulatory changes that make licensing non-LWRs more economically attractive. For example, the scope of EP requirements may be less expansive for non-LWRs, and rulemaking would pressure-test public concern.

The NRC’s readiness strategy for licensing non-LWRs includes the publication of a strategy report, regulatory guide, and rulemaking efforts. As envisioned in the agency’s strategy report, the NRC plans to develop a dynamic regulatory framework for licensing non-LWRs. This framework will make it easier for the agency to review non-LWR designs, and is enhanced by documents such as regulatory guidance specific to non-LWR technology. Although there is a great deal of work ahead, these actions help move the NRC toward readiness, by helping to optimize the agency’s regulatory operations in the area of non-LWR licensing.

Maxine Segarnick is an attorney in the Office of the General Counsel at the U.S. Nuclear Regulatory Commission. The views expressed in this article are solely those of the author and do not represent the views of the U.S. Nuclear Regulatory Commission.

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BEYOND NUCLEAR V. U.S. DEPARTMENT OF ENERGY: DISTRICT COURT ALLOWS DOE SHIPMENT OF LIQUID-FORM HIGHLY ENRICHED URANIUM FROM CHALK RIVER TO SAVANNAH RIVERAaron Flyer

The Department of Energy (DOE) is now cleared to ship over 6000 gallons of highly enriched uranyl nitrite liquid (HEUL or “target residue material”) from Chalk River, Ontario, Canada to DOE’s Savannah River site in South Carolina (SRS). In a February 2, 2017, order, the U.S. District Court for the District of Columbia denied a request to enjoin DOE from making the shipment. See Beyond Nuclear v. U.S. Department of Energy, No. 1:16-cv-04641-TSC (D.D.C. Feb. 2, 2017) (“Memorandum Opinion”). The plaintiffs, led by environmental advocacy group Beyond Nuclear, alleged that DOE’s decision to ship the waste in liquid form violated the agency’s obligations under the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. § 4321 et seq. Prior to the court’s February 2017 order, DOE had voluntarily postponed the shipments to allow the court to review the merits through expedited motions for summary judgment. See Joint Motion for Scheduling Order, Beyond Nuclear v. U.S. Department of Energy, No. 1:16-cv-04641-TSC (D.D.C. Sept. 20, 2016), ECF No. 9.

Background

The Chalk River HEUL material in dispute stems from the legacy Atoms for Peace Program, where the United States provided highly enriched uranium (HEU) for use, in part, as target material to be irradiated for the production of medical isotopes in foreign research reactors. Irradiating this target material, and extracting the medical isotopes, including molybdenum-99 as in the case of the Chalk River reactor, left a residual solution containing significant quantities of HEU. Due to proliferation concerns, the United States wants the HEU returned for safeguarding and disposal. See generally, Defendants’ Motion for Summary Judgment at 8–10, Beyond Nuclear v. U.S.

Department of Energy, (D.D.C. Nov. 4, 2016) (No. 1:16-cv-04641-TSC), ECF No. 15.

In 2008, the Canadian agency overseeing Chalk River informed DOE that they could no longer convert the liquid target residue material to solid form before shipment, as originally intended. See id. at 18–19. DOE agreed to accept the waste in liquid form and, after performing two Supplemental Analyses, determined that a supplement to the initial 1996 Environmental Impact Statement (EIS) was not required. See DOE, DOE/EIS-0218-SA-07, SUPPLEMENTAL ANALYSIS FOR THE FOREIGN RESEARCH REACTOR SPENT NUCLEAR FUEL ACCEPTANCE PROGRAM—HIGHLY ENRICHED URANIUM TARGET RESIDUE MATERIAL TRANSPORTATION at 20 (2015) (liquid shipment “would represent neither substantial changes to the action evaluated in previous NEPA analysis . . . nor represent significant new circumstances or information relevant to environmental concerns.”).

NEPA Complaint

Beyond Nuclear claimed that DOE’s decision to accept the target residue material in liquid form constituted a major federal action requiring a new or supplemental EIS, and DOE’s use of Supplemental Analyses bypassed the opportunity for public comment as required by NEPA. See Amended Complaint ¶ 66, Beyond Nuclear v. U.S. Department of Energy (D.D.C. Aug. 17, 2016) (No. 1:16-cv-04641-TSC), ECF No. 4. Beyond Nuclear argued that the target residue material was essentially liquid high-level radioactive waste and maintained that a full EIS was required because, in part, the federal government had previously concluded that shipment of such waste in liquid form was undesirable. See Plaintiffs’ Cross Motion for Summary Judgment at 12, Beyond Nuclear v. U.S. Department of Energy (D.D.C. Nov. 19, 2016) (No. 1:16-cv-04641-TSC), ECF No. 19. Because of the high risk associated with shipping target residue material in liquid form, Beyond Nuclear desires the waste to be solidified or down-blended at Chalk River before shipment. See id. at 37–38. In response, DOE pointed to its


regulations requiring preparation of a supplemental analysis “[w]hen it is unclear whether or not an EIS supplement is required.” See Defendants’ Motion for Summary Judgment at 6 (citing 10 C.F.R. § 1021.314(c)). DOE argued that the need for a supplemental EIS is based on the significance of the environmental effects of the change, not by the fact that the proposal is being modified. See id. at 31. Because the potential environmental impacts of accepting target residue material in liquid form would not significantly differ from the thoroughly documented impacts of accepting the material in solid powder form, a supplemental EIS is not required. Id. at 40.

Beyond Nuclear argued that DOE’s prior EIS did not fully evaluate the dangers associated with shipping the target residue material in liquid form. But the court refused to second-guess DOE’s determination that a supplemental EIS was not required. The court stated that whether shipment of the material in liquid form creates risks significantly different from those already evaluated is a factual question for DOE to address, which the court may only overturn if the record reveals a clear error of judgment. See Memorandum Opinion at 12–13.

Although Beyond Nuclear used a number of different terms for target residue material to stress the heightened risks associated with its shipment, the court clarified that such terms are “meaningless in a technical sense.” Id. at 3. Specifically, Beyond Nuclear’s use of terms such as “‘nuclear waste,’ ‘toxic liquid stew,’ ‘highly-

radioactive liquid waste,’ or ‘a form of spent fuel’” contravened the precise definition of spent nuclear fuel in 42 U.S.C. § 10101, which does not include target material. Memorandum Opinion at 3 n.1. The court then evaluated the administrative record and found, contrary to Beyond Nuclear’s assertion, that there is no well-established and long-standing environmental policy stating that it is too dangerous to ship HEU in liquid form. Id. at 15. Instead, the court viewed Beyond Nuclear’s complaint as a factual dispute over DOE’s conclusions—conclusions implicating substantial expertise and are thus left to the informed discretion of the agency. Id. at 16.

Conclusion

The district court’s decision reinforces the procedural nature of NEPA. Courts will not question highly complex and technical conclusions drawn from agency decision making but will instead focus on the process used to get there. DOE relied on its own NEPA implementing regulations and existing policy decisions evaluating the risks of shipping HEU target residue material. As DOE set forth these regulations and policy decisions through formal notice and comment, DOE left the court little room to entertain Beyond Nuclear’s technical conclusion that shipment of liquid waste is far more dangerous than shipment in solid form.

Aaron Flyer is an associate at Morgan, Lewis & Bockius LLP. Aaron represents nuclear industry clients, including electric utilities, reactor vendors, other nuclear suppliers, and government entities on regulatory, commercial, and litigation matters.

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THE NRC REGULATES HISTORIC RADIUM CONTAMINATIONOlivia Mikula and Alana Wase

In 1898 radium was discovered by Pierre and Marie Curie. By the early 20th century, the popularity of the luminescent, highly radioactive element, naturally produced in the decay of uranium, was at its peak. Initially used in hospitals as a treatment for cancer, its success in part led to its widespread promotion. For curative properties, it was added to tooth paste, hair creams, and even some food. On other products, like watches and night-lights, it was applied to make items glow. U.S. Nuclear Reg. Comm’n (NRC), Radium (Feb. 10, 2017), https://www.nrc.gov/materials/radium.html.

It wasn’t until women who worked in a factory in Orange, New Jersey, painting watch dials with radium, fell ill that the element’s hazards became publicly known. The women had been instructed to lick the paintbrush, ingesting radium, to more finely apply it. Five women brought a lawsuit that languished at first, but then garnered strong media coverage and was settled. Tragically over the course of the suit, the “radium girls” fell so ill they were unable to attend their full hearing. Each one passed away during or after the suit. Mark Neuzil & William Kovarik, Mass Media & Environmental Conflict (1996), http://www.rst2.edu/ties/radon/ramfordu/pdffiles/The%20Radium%20Girls.pdf. Not shockingly, the commercial use of radium decreased significantly afterward; however, it stopped completely only 20 years ago.

Despite this long history of use and known dangers, it wasn’t until 2005 that discrete sources of radium became federally regulated. Section 651(e) of the Energy Policy Act of 2005 (EPAct) expanded the NRC’s jurisdiction over radioactive material. The definition of by-product material in the Atomic Energy Act of 1954, as amended (AEA), was changed to include discrete sources of radium-226 “produced, extracted, or converted after extraction . . . for use for a commercial, medical, or research activity.” See

EPAct, Pub. L. No. 109-58, § 651(e), 119 Stat. 594, 806–07 (2005); see also Atomic Energy Act of 1954, as amended, 42 U.S.C. § 2014 (2016).

In 2007, the NRC issued final regulations, addressing its jurisdiction over the newly covered radioactive material. See Requirements for Expanded Definition of Byproduct Material, 72 Fed. Reg. 55,864 (Oct. 1, 2007). The preamble in the Federal Register notice (FRN) notes that part of the impetus for the EPAct’s jurisdictional change was to ensure a more consistent, nationwide approach to regulation of these materials. See id. at 55,864, 55,865. Before this, discrete sources of radium-226 were regulated by the states, many of which had their own regulatory programs in place. See id. Some federal agencies had regulations to address these materials in circumstances like environmental protection, workplace safety, drug safety, transportation, and disposal, and a few still retain this limited jurisdiction. See id. at 55,865 (e.g., the Department of Transportation retains authority over interstate transport of materials).

The NRC’s regulations define a discrete source as “a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.” See id. at 55,888. This definition excludes naturally occurring radioactive material and sources of radium that are inadvertently concentrated. See id. at 55,870 (e.g., radioactive material inadvertently concentrated during water treatment plan processes). Notably, the NRC’s jurisdiction over by-product material does include contamination caused by past use of discrete sources of radium-226. See id. at 55,871. Due to the past use of radium and the lengthy half-life of the material (1600 years), NRC regulations focus on regulating historical and intact items containing radium-226. See id. (noting that “[a]lthough certain industrial devices such as moisture density gauges containing radium-226 are still in use, most radium-226 articles have not been produced for at least 20 years”). However, the regulations do not explicitly discuss contamination from past use. See id. at 55,871, 55,880.


Instead, the preamble to the FRN states that where contamination is found on an unlicensed site, “the NRC will address these situations on a case-by-case basis.” See id. at 55,880 (concluding that “[a]t this time, there is not enough known about the breadth or depth of these potential radium-226 contamination situations to determine if any additional requirements may be needed to address them”). It further explains that the NRC does not intend to pursue licensing where contamination is found on an unlicensed person’s property, but licensing may be pursued where “the site presents a significant threat to the public health and safety.” See id. at 55,902. Site owners are responsible for producing the funding for remediation of radium-contaminated sites. With regard to contaminated sites that are abandoned or unable to fund proper remediation, the NRC cannot use appropriated funds for this purpose. See id. at 55,903.

With this direction, the NRC pursued its jurisdiction over radium-226 at military sites undergoing cleanup efforts. After focusing on military sites contaminated with radium-226, the NRC became aware of non-military sites undergoing cleanup by other federal agencies. This prompted current efforts to identify, describe, and prioritize sites with the potential for radium contamination from historic commercial use. See Oak Ridge National Laboratory, Historical Non-Military Radium Sites Research Effort (2015), https://www.nrc.gov/docs/ML1629/ML16291A485.pdf. In general, the businesses that used radium, predominantly in the first half of the 20th century, are no longer in operation; properties have been sold and have undergone redevelopment. Current owners and occupants may be unaware of the site’s history.

The NRC is visiting these sites to identify whether there is any residual radium contamination that poses an immediate risk to public health and safety. In states in which the NRC regulates radium, 29 historic sites have been identified. In the 38 states in which the NRC has discontinued its regulatory authority (“agreement states” with NRC equivalent

regulations), the NRC has notified these agreement states of sites where contamination may exist.

In states where the NRC continues to have regulatory authority, letters have been sent to the site owners and the NRC is performing initial site visits and scoping surveys where necessary. In so doing, the agency determines whether contamination exists and its extent. Based on the results of the surveys, remediation may be necessary.

Because the owners of these sites were not previously licensed, and may not have been aware of the site history, many novel legal and policy issues are at the helm of the agency’s radiation efforts.

Olivia Mikula and Alana Wase are attorneys in the Office of General Counsel at the U.S. Nuclear Regulatory Commission. The views expressed in this article are the sole views of the authors and do not reflect the views of the U.S. Nuclear Regulatory Commission.

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UPDATE: EPA FINALIZES PROTECTIVE ACTION GUIDE MANUALN. Lindsay Simmons

The Environmental Protection Agency’s (EPA) PAG Manual: Protective Action Guides and Planning Guidance for Radiological Incidents (PAG Manual) is a document intended to provide federal, state, local, and tribal emergency management officials with guidance in order to make radiation protection decisions when responding to radiological emergencies. EPA, PAG MANUAL: PROTECTIVE ACTION GUIDES FOR PLANNING FOR RADIOLOGICAL INCIDENTS 1 (2017) [hereinafter 2017 PAG Manual]. The manual provides a series of protective action guides (PAG), which are “the projected dose to an individual from a release of radioactive material at which a specific protective action to reduce or avoid the dose is recommended.” Notice of Availability: Draft Protective Guide (PAG) for Drinking Water After a Radiological Incident, 81 Fed. Reg. 37,589, 37,590 (June 10, 2016). The recommended PAGs are divided into three phases, which correspond to different periods of time following a radiological emergency and which dictate the applicability of the PAGs. 2017 PAG Manual at 5. These phases are comprised of (1) the early phase, which lasts from several hours to days; (2) the intermediate phase, which lasts from several weeks to months; and (3) the late phase, which lasts for the duration of the cleanup. Id.

The original PAG Manual, published in 1992, did not include a drinking water PAG, but noted that “[p]rotective action recommendations for drinking water are under development by the EPA.” EPA, MANUAL OF PROTECTIVE ACTION GUIDES AND PROTECTIVE ACTIONS FOR NUCLEAR INCIDENTS (1992) [hereinafter 1992 PAG Manual]. When the EPA revised the 1992 PAG Manual in 2013, the update did not include a drinking water PAG. See EPA, PROTECTIVE ACTION GUIDES AND PLANNING GUIDANCE FOR RADIOLOGICAL EMERGENCIES: VERSION FOR INTERIM USE AND PUBLIC COMMENT 9 (2013). However, in the wake of the Fukushima accident, where Japanese drinking water supplies were

impacted, the agency recognized that a drinking water PAG may be appropriate and requested public comment on the subject. Id.; Updates to Protective Action Guides Manual: Protective Action Guides (PAGs) and Planning Guidance for Radiological Incidents, 72 Fed. Reg. 22,257, 22,259 (Apr. 15, 2013).

Thus, on June 10, 2016, EPA published its proposed drinking water PAG, and, on January 19, 2017, it announced the finalized addition of the PAG. Notice of Availability: Draft Protective Guide (PAG) for Drinking Water After a Radiological Incident, 81 Fed. Reg. 37,589, 37,590 (June 10, 2016); Revision to the PAG Manual: Protective Action Guide (PAG) for Drinking Water After a Radiological Incident, 82 Fed. Reg. 6498 (Jan. 19, 2017). This article summarizes (1) the original June 10, 2016, proposed changes to add the drinking water PAG to the manual; and (2) the comments received by EPA and its responses to those comments, including any revisions it made to the PAG Manual as a result.

June 10, 2016, Proposed Changes to the PAG Manual

The drinking water PAG was proposed to apply to the intermediate phase of an incident using a “two-tiered” approach, wherein two separate dose thresholds were recommended: (1) a PAG of 500 millirem (mrem) for the general population, and (2) a lower threshold of 100 mrem for pregnant women, nursing women, and children. Id. This two-tiered approach was designed to “balance the goal of keeping radiation doses as low as possible with the practical and logistical challenges of providing alternative drinking water during the response to a disaster.” Id. at 37,591. EPA also emphasized that the PAG was not intended to represent an “acceptable” routine exposure level, but to inform emergency response officials of the dose level where protective action is advised in order to avoid or reduce further dosage. Id. EPA further distinguished between the PAG for drinking water, which was intended to be used by emergency responders as a guide for immediate


protective action, and the National Primary Drinking Water Regulations’ (NPDWR) exposure criteria for radionuclides, which assumes 70 years of continued exposure. Id. Thus, EPA noted that the NPDWR, while an appropriate framework for exposure limits under normal operating conditions, may not provide useful guidelines for an emergency situation. Id.

Comments on the Proposed Drinking Water PAG

EPA received over 60,000 comments on the proposed drinking water PAG dose levels. These generally fell into one of two groups. The first group, which encompassed the majority of the commenters, primarily asserted that the proposed PAG dose levels were insufficiently stringent or questioned whether they considered all relevant factors. Some of these commenters expressed concern that the proposed guidance would weaken the regulatory requirements of the Safe Drinking Water Act or that the proposed dose levels were too high, and should instead be based on the NPDWRs for radionuclides. 82 Fed. Reg. at 6499. The same group was also concerned that the duration of the PAG could last for over a year. Id. And last, this group questioned whether EPA considered the potential for cumulative effects from drinking contaminated water. Id. The second group of commenters advocated for a higher PAG dose level, one that fell in the 2000 to 10,000 mrem range. Id.

In response to the first group of commenters, EPA amended the guidance in order to emphasize that the PAG recommendations are limited in scope to nationally significant radiological contamination incidents, such as a nuclear power plant disaster. Id.; see also EPA, 2017 PAG Manual. It further emphasized that the guidance is not intended to be used for long-term exposure, and thus the PAG Manual specifies that the duration of the PAG may last from several weeks to several months, but it may not last for longer than a year. 82 Fed. Reg. at 6499; see also EPA, 2017 PAG Manual at 53. And last, EPA explained that the PAG dose levels take

into account cumulative exposure from multiple potential sources, including plume inhalation, immersion, ground shine, and drinking water and food ingestion. 82 Fed. Reg. at 6499. However, it noted that it was impractical to compartmentalize joint protective actions, given that individual exposure and site-specific conditions will differ on a case-by-case basis. As such, the agency noted that emergency responders are better equipped to consider all relevant exposure routes when making protective action decisions. Id.

In response to the second group of commenters, EPA expressed that it would not change the 500 mrem or 100 mrem PAG dose levels because the chosen dose levels are consistent with currently available guidance for other exposure pathways during the intermediate phase; and drinking water recommendations should take into account sensitive life stages, such as children, pregnant women, and nursing women. Id. Ultimately, EPA did not make any substantive changes to the finalized drinking water PAG as a result of the comments it received. See 2017 PAG Manual at 53.

N. Lindsay Simmons is an attorney at the Atomic Safety & Licensing Board Panel at the U.S. Nuclear Regulatory Commission. The views in this paper are solely those of the author and do not represent those of the U.S. Nuclear Regulatory Commission or the Atomic Safety & Licensing Board Panel.

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12 Nuclear Law Committee, May 2017Published in Natural Resources & Environment Volume 31, Number 4, Spring 2017. © 2017 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.

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