Editor's note: This article will also appear in a future issue of the Health Physics Society's newsletter, Health Physics News.
On August 8, 2005, the President signed into law the Energy Policy Act of 2005 (EPAct) on "Treatment of Accelerator Produced and Other Radioactive Material as Byproduct Material." Section 651(e) of the EPAct expanded the definition of byproduct material as defined in the Atomic Energy Act of 1954, as amended (AEA), and placed additional byproduct material under the U.S. Nuclear Regulatory Commission's (NRC’s) jurisdiction as defined in section 11e.(3) and 11e.(4) of the AEA.
On March 20, 2007, the NRC issued Regulatory Issue Summary (RIS) 2007-05 to inform recipients of the status of the NRC’s efforts to implement the requirements of Section 651(e) of the EPAct. The RIS, along with a list of "Frequently Asked Questions" is available for review on-line. You may also access the "NARM Toolbox" at the NRC’s Office of Federal and State Materials and Environmental Management Programs (FSME) website for additional information on naturally occurring and accelerator-produced radioactive material (NARM) related activities.
Section 651(e) of the EPAct requires that the commission issue final regulations establishing requirements for licensing and regulating section 11e.(3) and 11e.(4) byproduct material, while cooperating with the states and using model state standards to the maximum extent practicable. NRC has made significant progress toward completion of the final regulations, which are currently expected to be published in the spring of 2007. The final regulations will become effective 60 days after the date of publication, and will be posted to NRC’s Public Involvement Rulemaking website. Throughout the rulemaking process, the NRC has actively worked with both Agreement States and non-Agreement States, through the Organization of Agreement States and the Conference of Radiation Control Program Directors, as well as with NRC’s Advisory Committee on the Medical Uses of Isotopes, other Federal agencies, professional organizations, and the medical community.
As provided for by the EPAct, the commission issued a waiver on August 31, 2005, (70 FR 51581) to (1) allow states to continue with their regulatory programs for NARM; (2) allow persons engaged in activities involving NARM to continue with their operations in a safe manner; and (3) allow continued use of radiopharmaceuticals for medical purposes. The waiver is in effect through August 7, 2009, unless the commission terminates it earlier.
The commission plans to terminate the waiver in phases, after the final rule is issued, starting from the effective date of the rule and ending on August 7, 2009. During the initial phase of waiver terminations, which will occur in conjunction with the effective date of the final rule, the commission intends to terminate the waiver for federal government agencies, federally recognized Indian tribes, Delaware, District of Columbia, Puerto Rico, the U.S. Virgin Islands, Indiana, Wyoming, and Montana.
At this time, the timing and schedule for waiver terminations for the remainder of the non-Agreement States and U.S. territories have not been established. A notice in the Federal Register will be published approximately six months before the effective date of the waiver termination to notify users of their waiver terminations and implementation dates of the rule. NRC staff will notify impacted state regulators individually prior to the publication of the Federal Register notice. The NRC also plans to provide additional notification to known entities impacted by the initial phase of waiver terminations following publication of the final rule in the Federal Register.
Upon waiver termination, all persons that possess the new byproduct materials in these states, U.S. territories, or areas of exclusive Federal jurisdiction must be in compliance with NRC regulations, including, for example, meeting the reporting and recordkeeping requirements for the new byproduct material. Such persons will also either be required to 1) apply for license amendments for the new byproduct material within 6 months from the date the waiver is terminated, if they hold an NRC specific byproduct materials license; or 2) submit a license application for the new byproduct material within 12 months from the date the waiver is terminated.
In conjunction with the effective date of the final rule, the commission also intends to terminate the waiver for any of the 34 Agreement States that provide a certification from their governor to the commission as described in the EPAct and the commission's transition plan mandated by the EPAct (see below). Users of the new byproduct materials in Agreement States should contact their respective Agreement State regulatory agency with any questions related to plans for continuing to regulate these materials.
The EPAct requires the NRC to prepare and publish a transition plan to facilitate an orderly transition of regulatory authority with respect to the newly added byproduct material. The transition plan addresses both Agreement and non-Agreement States, and has been coordinated extensively with the states. The NRC anticipates that the final transition plan will be published in conjunction with the final regulations in the Federal Register, as required by section 651(e) of the EPAct. The RIS provides additional information including where to locate a copy of the draft transition plan as well as NRC plans for publication of the final transition plan.
The NRC staff is also working on several activities that will be needed to support NRC’s new regulatory authority. Specifically, the NRC staff is working on finalizing revisions to guidance contained in NUREG-1556, Volumes 9 and 13, and developing a new NUREG (NUREG-1556, Volume 21), which is focused on the production of radioactive material using an accelerator. The NRC staff is also planning to make minor revisions to other guidance documents and procedures to reflect the regulation of the new byproduct material.
Contacts: Andrew Mauer or Duane White, U.S. Nuclear Regulatory Commission, Office of Federal and State Materials and Environmental Management Programs, 301-415-3962 or 301-415-6272; e-mail: anm@nrc.gov or dew2@nrc.gov