Update on the Nuclear Regulatory Commission's Energy Policy Act: From the States' Viewpoint
Editor's note: Our thanks to Martha Dibblee, State of Oregon, for this personal account of her experiences as a Nuclear Regulatory Commission (NRC) "employee" chosen to represent the Conference of Radiation Control Program Directors (CRCPD) on the NRC's Energy Policy Task Force.
Being the first state employee to also be an NRC employee, I truly was an enigma, at least for NRC management.
Within a week after I arrived in Rockville, Maryland (having moved from Portland, Oregon), I received a "contractor badge" and became an "ordinary NRC staff person." I had a cubicle, an e-mail address, a telephone, a computer, and a chair. The cubicle was small, but I soon learned that it actually was bigger than some. There was room for two chairs. Being from Oregon and commuting there every three to four weeks, the NRC work schedule policy made my life very tolerable. The NRC, rated among the federal government as the number 3 "best place to work," offers a variety of flexible work schedules. I worked 9-to-6 but also became one of the regulars on the "night crew."
The Energy Policy Act of 2005 (the EPAct) gave NRC authority to regulate naturally-occurring and accelerator-produced radioactive material. The EPAct limited the scope of the rulemaking and included timelines. The EPAct language in Section 651 limited NRC’s authority to "accelerator-produced materials produced for medical, academic, or industrial use" and "discrete sources" of radium-226. We refer to these new materials as 11e.(3) and 11e.(4) materials.
The EPAct required the NRC to "cooperate with states" in writing regulations to support the statutory language in the act. To comply with the requirements of the EPAct, the Office of Nuclear Material Safety and Safeguards/Division of Industrial and Medical Nuclear Safety (NMSS/IMNS, which has responsibility for drafting rules for the NRC) formed a "task force" composed of state members, including persons who would work alongside the NRC employees.
The NMSS/IMNS sent out a solicitation of interest for a state person to join IMNS staff and participate in the rulemaking required by the EPAct. No state person accepted this solicitation; as a retiree (1998) from Oregon’s Radiation Protection Services (former manager of materials), I was asked to do this and accepted the challenge. In addition to my in-house position, Lee Cox of North Carolina committed continual and significant time and effort--knowledge and skills-–to support the rulemaking process, participating in four of the major work groups involved in the NRC’s efforts to implement the EPAct (not all work groups were involved in the rulemaking; the EPAct required more than rulemaking).
The Atomic Energy Act of 1954 grandfathers all legislation pertaining to the domestic use of byproduct material in the U.S. Although individual states have, over the years, regulated "all radioactive material" according to individual statutes, the federal regulation of radioactive material was limited to "byproduct material."
The Atomic Energy Act (AEA) of 1954 gave the federal government authority to regulate certain radioactive materials known as "byproduct materials." This grew out of the legacy of nuclear fission reactors, activation products, fallout, and the nuclear fuel manufacturing process (the fuel cycle). Any other radioactive material, which at the time was constrained primarily in research environments, was not included in the definition of "byproduct material."
The AEA was amended several times as the nuclear industry matured and as states began regulating radioactive material. The NRC website gives an overview of timelines and history of the various federal energy acts. Some of these acts amended the definition of "byproduct material" in the AEA. The latest revision of the AEA, the Energy Policy Act of 2005, amends the AEA to include certain (emphasis added) accelerator-produced radionuclides, radium-226, and any other naturally-occurring radioactive material that would have the same or greater risk as radium-226. Until now, byproduct material was known as "11e.(1)" or "11e.(2)" byproduct material; byproduct material now includes, in addition to 11e.(1) and (2), 11e.(3) material (certain accelerator-produced radionuclides and radium-226) and 11e.(4) material (naturally-occurring radioactive material that would have the same or greater risk as radium-226). It is the rulemaking for the latter two, 11e.(3) and 11e.(4) material, that the Energy Policy Task Force oversaw.
The NRC, unlike states, staffs its sections with persons who are experts in a particular discipline. This process, although appearing to be prodigal, provides the commission with the best possible outcomes, whether the discipline is health physics, statistics, writing, licensing, rulemaking, inspection, design, evaluation, risk assessment-–whatever discipline might be required. Having a ready inventory of experts provided the immediate resources required when the EPAct stipulated timelines.
The IMNS management selects a task or work group leader, depending on knowledge and skills in the target project. In the case of the EPAct rulemaking, the goal was to draft rules that implemented the statutory language in the EPAct. There were three rulemaking work groups in all. The first work group, the Technical Basis Work Group, functioned until the basis information was acceptable to the NRC lawyers. This work group included a number of states plus about a dozen NMSS staff in a variety of disciplines, from a number of sections. Eventually this work group morphed into the Rulemaking Work Group with added and subtracted staff. Again, there was significant state representation. State participants will attest that discussions often became heated, albeit over the phone lines for 2-3 hours at a time. Clearly this wasn’t the best process--I, being physically with NRC staff, served as the "watchdog"--but still NRC learned the basics from states, especially about management of accelerator-produced nuclides.
The third rulemaking work group was formed to provide guidance if states needed to make changes to their statutes and regulations. Changes will depend on commission decisions; at this time they are not final. The EPAct language stated that an agreement state’s agreement would be "considered to be amended to include 11e.(3) and 11e.(4) byproduct material" if the governor of the state "certified to the commission on the date of publication of the transition plan" that the state had a "program that was adequate to protect public health and safety with respect to these materials" (i.e., 11e.(3) and 11e.(4) byproduct material). This part of the EPAct is known as the "Transition Plan" for the rulemaking.
A second part of the Transition Plan provides guidance for states that might become agreement states. Some states had "mature" regulatory programs for naturally-occurring and accelerator-produced radioactive materials (NARM); when the rulemaking becomes final, those nonagreement states--those states without a formal agreement to regulate byproduct material--no longer would be able to regulate 11e.(3) and 11e.(4) byproduct material.
Most work gets organized and assigned in work groups. Work groups are made up of nonmanagement staff overseen by a manager (usually a section leader). Work group procedures are spelled out in NRC Management Directive 5.3 (an approved procedure). The team leader, who may be the project manager, manages the meetings, prepares the agenda, takes notes (or asks someone to help), and generally oversees the scope and progress of the task at hand. That person may be called upon to provide progress reports to management.
Work groups may have several functions within a given project including research, writing, and implementation. When one part is finished, the work group either is disbanded or it morphs into another functionality, which also may include a change of personnel. I was part of Lydia Chang's Rulemaking Work Group, and I also was a member of the work group that promulgated regulations for sections 652 and 656 of the EPAct (security requirements during transportation for import-exports, which is exclusive federal jurisdiction). Although I was not a member of the Security of Materials and Increased Controls (IC) Work Group, I attended those meetings periodically as a member of the task force which had responsibility for its oversight.
During the research phase of the Rulemaking Work Group, Lee Cox (Organization of Agreement States/North Carolina [OAS/NC]) and I conducted the state surveys that establish the technical basis for the rule. (Lee Cox also was heavily involved with the ICs during this period; orders were sent to licensees to implement the requirements of the increased controls for quantities of concern.) NRC research staff compiled the exempt quantity tables deferring to the suggested state regulations (SSRs); I worked in the radium focus group, which provided insight into how states regulated radium. We attempted to estimate a nation-wide radium inventory. And although Office of Management and Budget (OMB) clearances allowed work group members to ask specific questions about radium, few states knew their exact inventory.
Also during the research phase, the work group toured the National Institutes of Health (NIH) positron emission tomography (PET) facility to learn how they did business. The NIH has three accelerators--two are research devices and one functions conceptually as an "accelerator-in-a-box." Work group members queried the very knowledgeable research physicists about safety, contamination, decommissioning, and isotope production, notwithstanding that this facility, under exclusive federal jurisdiction, was not regulated. In addition, state experts provided model PET licenses to the work group so NRC could see how the states wrote licenses for PET facilities, both stand-alone nuclide production (as a pharmacy) and routine use (unit doses from a pharmacy).
The exempt quantity table, Schedule B of Title 10 of the Code of Federal Regulations (CFR), Part 30.71, was updated mostly verbatim from the 1991 SSRs after verifying the pedigree of the 1991 SSRs (the EPact required the NRC to "use model state regulations" as a model for the rulemaking). The verification process is done at the federal level--and indeed it had been done before, when those tables were issued in the SSRs in 1991--so states don't have to go through this step. Showing a pedigree to the National Commission on Radiation Protection's (NCRP's) Report 2 or other relevant documents provided a consistent and accurate risk model for these numbers.
During the writing phase, information gathered from the research phase was incorporated into the draft Federal Register notice. Most everyone on the work group had a writing assignment. The team leader (Lydia) had the responsibility to compile all comments from the various authors into a coherent document by a preset deadline. If the deadline was tight, the work group leader or principals might spend up to 16 hours a day writing.
Everything that's written--prior to anything being published in the Federal Register notice and the public website--is scrutinized (reviewed in detail) by Office of General Counsel (OGC) staff. Whether adding a single nuclide to a table, a Federal Register notice, an SECY (a commission paper that provides the descriptor or introduction to a technical document or rulemaking that the commissioners must act upon), or a complete rulemaking such as this was, there must be a pedigree--a basis--on which lawyers rely for the legal strength of the document or rule. For a rulemaking, the bottom line legally is that everything must be rooted in Constitutional law and Federal legislation and code. Providing the lawyers with the complete picture from start to finish--the basis documents from concept to rule draft--also means that states can use these rule texts without further legal test once they've been through the federal system.
However, being thorough takes time. Moving through the layers of lawyers and management concurrence takes time. Corrections and revisions take time. Concurrence happens at the end, before a document goes to the commission.
Allegations or findings of fatal flaws--something critical that's been omitted or an incorrect or inaccurate statement--require more research and lawyer time and effort, which was why the research phase needed to be complete before the rule draft was started. New information that affected completeness needed to be researched and concurred--days or weeks of work--in an already-tight timetable.
The Agreement State Program was established by Congress in 1959 and the first agreement state was Kentucky in 1962. Over the next 40 years, 34 states have become agreement states; one state (Idaho) rescinded its agreement. Agreement states have signed a formal document with the NRC–-signed by the governor of the state and the chairman of the commission--to take over the regulation of byproduct material, excluding only special nuclear material in critical quantities and distribution of exempt quantities of byproduct material. Until now, this included only 11e.(1) and/or 11e.(2) byproduct material. If the governor certifies adequacy for 11e.(3) and 11e.(4) byproduct material, the state’s agreement is automatically considered to include all byproduct material – including the newly-added 11e.(3) and 11e.(4) byproduct material. Since not all byproduct material was regulated by NRC, some states wrote exempt distribution licenses for NARM; those licensees will transition to the NRC because NRC retains authority for exempt distribution licenses.
NRC rulemakings are the responsibility of NMSS. The Energy Policy Task Force was created after the EPAct mandated cooperation with states. NRC normally does not use the task force model, but in this case, which presented multiple oversight tasks, it was the best choice (personal communication with Joe DeCicco, March 31, 2006). In keeping with the mandate to cooperate with states, NRC selected two state representatives (a number of other state representatives were members of the Rulemaking Work Group and other EPAct-related activities such as the ICs) for the task force in addition to representatives from NMSS/IMNS, Nuclear Security and Incident Response (NSIR), and the Office of State and Tribal Programs (STP). The task force's steering committee was formed in January in accordance with NRC Management Directive and Handbook 5.3, NRC and Agreement State Working Groups. The steering committee comprised managers from STP, OGC, NMSS/IMNS, NSIR, OAS, CRCPD, and the Health Physics Society (HPS).
The task force charge and charter included responsibility for International Atomic Energy Agency (IAEA) sources of concern (ICs), as well as the rulemakings for the expanded definition of byproduct material and security of transportation for export-imports. The task force was led by Doug Broaddus, NMSS/IMNS staff member. Doug's broad base of experience in various areas (the Sealed Source and Device Section, Sealed-Source Tracking Project, Commissioner Technical Assistant) as well as his attention to detail played a large part in his success as leader of this rather formidable project.
The timeline mandated by Congress in the EPAct played a large role in events during the past nine months. After the EPAct was signed on 8 August 2005, NRC prepared the Federal Register notice that announced the waiver of requirements of the EPAct for four years. The authority for a waiver of requirements was part of the EPAct. This blanket waiver gave NRC time to do the rulemakings and implement the increased controls for both NRC and state licensees. The waiver dated 31 August 2005 was retroactive to the date of enactment of the EPAct (8 August 2005) to prevent regulatory gaps.
Starting in January 2006, along with the task force leader Doug Broaddus, a half dozen NRC staffers, and two state representatives, I was the lead for the Transition Plan brainstorming sessions. These brainstorming sessions resulted in notes, edited in detail by OGC, that became the basis of the written Transition Plan (a subsection of the rulemaking section of the EPAct). It was during these sessions that our lawyer patiently explained what OGC believed Congress intended in this section.
The Transition Plan laid out the procedure for both agreement and nonagreement states to regulate NARM. Included in the Transition Plan was a communication plan. The communication plan is an internal (i.e., NRC-only) document that NRC staff will use during the implementation phase of the rule. It included a timeline and relevant frequently asked questions (FAQs) that will assist staff during this time. Another NRC staff person and I wrote the draft communication plan.
As I described above, the technical basis-I from establishing the criteria for the rule--was the first order of business. The state survey (agreement states were surveyed by task force member Lee Cox of North Carolina; nonagreement states and territories were surveyed by me) provided the very important basis--the knowledge base--on which NRC would draft the rule. The mandate by the EPAct to use "model state regulations" meant that the CRCPD SSRs would be used as the model. The EPAct also stipulated that the version of model state regulations to be used would be those in effect on the date of enactment. The 1991 version of the SSRs was the last complete version of the SSRs; therefore those were used.
To augment the state survey, work group members gathered relevant information about NARM sealed source and device registrations issued by states, about accelerator-produced materials, and about radium. Staff crafted a definition of "discrete source" because the EPAct required NRC to define this term. The EPAct rulemaking included only those sources of radium that met the definition of a discrete source.