Requirements for Expanded Definition of Byproduct Material

NUCLEAR REGULATORY COMMISSION

10 CFR Parts 20, 30, 31, 32, 33, 35, 50, 61, 62, 72, 110, 150, 170, and 171

RIN 3150-AH84

Requirements for Expanded Definition of Byproduct Material

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Final rule.

SUMMARY:

The Nuclear Regulatory Commission (NRC) is amending its regulations to include jurisdiction over discrete sources of radium-226, accelerator-produced radioactive materials, and discrete sources of naturally occurring radioactive material, as required by the Energy Policy Act of 2005 (EPAct), which was signed into law on August 8, 2005. The EPAct expanded the Atomic Energy Act of 1954 definition of

Byproduct material

to include any discrete source of radium-226, any material made radioactive by use of a particle accelerator, and any discrete source of naturally occurring radioactive material, other than source material, that the Commission, in consultation with other Federal officials named in the EPAct, determines would pose a similar threat to the public health and safety or the common defense and security as a discrete source of radium-226, that are extracted or converted after extraction for use for a commercial, medical, or research activity. In so doing, these materials were placed under the NRC's regulatory authority. The EPAct also mandated that the Commission, after consultation with the States and other stakeholders, issue final regulations establishing requirements that the Commission determines necessary under the EPAct. This rulemaking effort has been undertaken in response to that mandate and includes significant contributions from many States that have regulated the naturally occurring and accelerator-produced radioactive material, the Organization of Agreement States, Inc., the Conference of Radiation Control Program Directors, Inc. (CRCPD), and other stakeholders. In addition, this final rule was informed and guided by the CRCPD's applicable Suggested State Regulations for the Control of Radiation. Licensees, individuals, and other entities who are engaged in activities involving the newly defined byproduct material in both Agreement States and non-Agreement States and United States Territories will be affected by this rulemaking.

DATES:

Effective Date:

This final rule is effective on November 30, 2007.

FOR FURTHER INFORMATION CONTACT:

Lydia Chang, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6319, e-mail

lwc1@nrc.gov

; or Catherine R. Mattsen, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6264, e-mail

crm@nrc.gov

.

SUPPLEMENTARY INFORMATION:

I. Background

II. Discussion

A. The New, Expanded Definition of Byproduct Material

B. The NRC's Regulatory Approach

C. Changes to Existing NRC Regulations to Accommodate the New Byproduct Material

D. License Application and Annual Fees

E. Implementation Strategy

III. Summary and Analysis of Public Comments on the Proposed Rule

IV. Section-by-Section Analysis of Final Revisions

V. Criminal Penalties

VI. Agreement State Compatibility

VII. Voluntary Consensus Standards

VIII. Environmental Assessment and Finding of No Significant Environmental Impact: Availability

IX. Paperwork Reduction Act Statement

X. Regulatory Analysis

XI. Regulatory Flexibility Certification

XII. Backfit Analysis

XIII. Congressional Review Act

I. Background

The Energy Policy Act of 2005

On August 8, 2005, the President signed into law the EPAct. Among other provisions, Section 651(e) of the EPAct expanded the definition of Byproduct material as defined in Section 11e. of the Atomic Energy Act of 1954 (AEA), placing additional byproduct material under the NRC's jurisdiction, and required the Commission to provide a regulatory framework for licensing and regulating this additional byproduct material.

Specifically, Section 651(e) of the EPAct expanded the definition of Byproduct material by: (1) Adding any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after the date of enactment of the EPAct for use for a commercial, medical, or research activity; or any material that has been made radioactive by use of a particle accelerator and is produced, extracted, or converted after extraction, before, on, or after the date of enactment of the EPAct for use for a commercial, medical, or research activity (Section 11e.(3) of the AEA); and (2) adding any discrete source of naturally occurring radioactive material, other than source material, that the Commission, in consultation with the Administrator of the Environmental Protection Agency (EPA), the Secretary of the Department of Energy (DOE), the Secretary of the Department of Homeland Security (DHS), and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and is extracted or converted after extraction before, on, or after the date of enactment of the EPAct for use in a commercial, medical, or research activity (Section 11e.(4) of the AEA).

Although Section 651(e) of the EPAct became effective on August 8, 2005, the NRC did not have regulations in place that would specifically apply to this newly covered byproduct material (hereafter referred to as NARM). The EPAct also allowed the NRC to issue waivers to States and other entities while developing final regulations for NARM. A waiver was issued on August 31, 2005 (70 FR 51581).

Previous Regulatory Structures for NARM

The AEA authorizes the States to assume regulatory control of certain radioactive materials provided the State has an adequate program to protect the public health and safety and is compatible with the NRC's program for regulation of these materials and enters into an agreement with the NRC. As authorized by Section 274b of the AEA, 34 States have assumed responsibility for regulating certain activities related to radioactive material by entering into agreements with the NRC. The activities regulated by these “Agreement States” include the use of byproduct material, source material, and special nuclear material. Each Agreement State issues licenses to persons who use these materials in that State except for DOE, other Government agencies, and Federally recognized Indian Tribes. The NRC issues licenses to persons using these materials in non-Agreement States.

Before enactment of the EPAct, the NRC did not have authority over NARM or regulations for this type of material. Although the NRC has not regulated NARM in the past, all 34 Agreement States and certain non-Agreement States have regulatory programs for NARM. The NRC's regulations did require licensees to account for dose contributed from NARM, as well as dose

contributed from other byproduct, source, or special nuclear material, because the definition of Occupational dose encompasses both licensed material and nonlicensed material such as NARM sources at a licensed facility. In addition, the NRC requires in its radiological criteria for license termination that licensees consider other nondiscrete sources, including radium, during decommissioning activities at sites contaminated with source material, such as rare-earth processing facilities.

Currently, there are 16 non-Agreement States plus United States (U.S.) Territories. Although most non-Agreement States and U.S. Territories have some type of programs for NARM, the regulatory structures vary greatly. Certain non-Agreement States have established a licensing structure for regulating their NARM users. As such, the regulatory structure could parallel the NRC regulations issued in Title 10 of the Code of Federal Regulations (10 CFR) applicable to the current materials program, or it could parallel the Suggested State Regulations for the Control of Radiation (SSRs) developed by the CRCPD. Other non-Agreement States or U.S. Territories have elected to use registration as their regulatory structure for managing the NARM users. Some States register facilities; others register both facilities and devices. Some States use registration information to conduct inspections; others use registration to identify facility locations for security purposes. In general, there is limited regulatory oversight where registration is used in non-Agreement States. It was, in part, due to this lack of national consistency, that the EPAct placed these materials under the NRC's jurisdiction.

Agreement States have regulated NARM use for many decades in a fairly uniform and consistent manner. The Agreement States have accomplished this by using the same standards to regulate NARM as those used to regulate other byproduct, source, and special nuclear material under the NRC's authority. In many respects, regulations applicable to NARM adopted by the Agreement States are compatible with the NRC's regulations for the current materials program, or parallel the CRCPD's SSRs.

Although Agreement States do have some provisions specifically for NARM, in general, the regulatory structure used by Agreement States does not distinguish between NARM and other radioactive material. NARM users in the Agreement States are expected to implement all aspects of standards for their radiation protection programs with respect to NARM, including those aspects relating to receipt, possession, use, storage, transfer, transportation, and disposal of NARM. This regulatory structure also subjects NARM users in the Agreement States to the same licensing, inspection, and enforcement policies as those using other byproduct, source, or special nuclear materials. In addition, this regulatory structure allows for both specific and general licensing of various NARM products, the distribution of certain NARM items to persons exempt from regulation and, in most cases, includes provisions to review and approve proposals for sealed sources and devices containing NARM.

The Agreement States have regulated a vast array of NARM produced for medical, industrial, research and development, commercial, and consumer purposes. In many Agreement States, this regulatory structure also captures some types of nondiscrete sources found in the oil and gas industry or mining industry; moreover, it captures inadvertently produced activation products from the use of proton beams for medical radiation therapy. However, the regulation of these nondiscrete sources and activation products varies from Agreement State to Agreement State.

Other Federal Agencies' Regulatory Authority Over NARM

Although the States had the primary responsibility for regulating the use of NARM before the passage of the EPAct, certain Federal regulations continue to apply under some circumstances, such as environmental protection, workplace safety, drug safety, transportation, and disposal. With the passage of the EPAct, the NRC will have primary responsibility for radiation safety and in regulating the use of these materials in cooperation with the States, with the exception of those activities that are self-regulated by the DOE.

Other Federal agencies have regulations or have established programs for self-regulating certain activities involving NARM. The Department of Transportation (DOT) regulates interstate transport of NARM. In cooperation with DOT, the NRC approves Type B packages through regulations in 10 CFR Part 71. The EPA has established controls for certain NARM through several authorities, including the Clean Air Act, the Safe Drinking Water Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and the Comprehensive Environmental Response, Compensation, and Liability Act. The Occupational Safety and Health Administration (OSHA) of the Department of Labor has the oversight for occupational health and safety for radiation protection. It has regulations governing radiation protection in the workplace, including provisions addressing the exposure of minors to radioactive material in the workplace, but defers to the NRC on AEA materials. The Department of Commerce (DOC) has controlled the export of radioactive material. Before the enactment of the EPAct, the DOC regulated the export of all radium-226. With the enactment of the EPAct, the NRC will regulate the export of discrete sources of radium-226; DOC retains jurisdiction to regulate the export of nondiscrete sources of radium-226. The Consumer Product Safety Commission regulations have addressed hazardous substances other than byproduct, source, and special nuclear materials currently regulated by the NRC. The Food and Drug Administration (FDA) regulates all drugs (including drugs containing radioactive materials) by requiring good manufacturing practices to assure the purity, potency, and consistency of finished drugs with their labeling in establishing the safety and effectiveness of these drugs.

Section 651(e)(3) of the EPAct provides that byproduct material, as defined by Section 11e.(3) or 11e.(4) of the AEA, may only be transferred to and disposed of in a disposal facility that is adequate to protect public health and safety, and is licensed by either the NRC or a State that has entered into an agreement with the Commission under Section 274b of the AEA or at a disposal facility in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, also known as the Resource Conservation and Recovery Act (RCRA).

Development of the Suggested State Regulations (SSRs)

Since enactment of the AEA in 1954, scientists continue to develop new technologies in producing radionuclides, such as the use of particle accelerators. At the beginning of the 20th century, naturally occurring radioactive material, including radium-226, was routinely used in consumer products and in cancer treatment. Because there was no Federal mandate to regulate these materials, most States have since established regulatory structures for both accelerator-produced radioactive material and naturally occurring radioactive material, including radium-226.

In 1968, CRCPD was chartered as a nonprofit organization to provide a forum for enhancing communication among States and Federal agencies

regarding radiation regulations and to promote a uniform radiation protection environment for all radioactive material. Throughout the years, CRCPD developed policies and guidance for its member States. In addition, CRCPD is responsible for the development of model regulations, known as the SSRs. Under the SSRs' regulatory framework, NARM has been a regulated radioactive material comparable to byproduct material. Nearly all of the Agreement States have based their regulations on this model for NARM.

For NARM regulation only, CRCPD also established “Licensing States” similar to the Agreement State Program under Section 274 of the AEA. Licensing States recognized by CRCPD under criteria found in Publication 94-8, “CRCPD Recognition of Licensing States for the Regulation and Control of NARM,” are those States that have demonstrated an adequate and consistent regulatory control program for NARM. Licensing State designation assures comparable regulatory structures with respect to NARM, and other States may grant reciprocal recognition of their licenses or acceptance of their licensees' manufactured products.

Issuance of Waiver on August 31, 2005

Section 651(e) of the EPAct became effective immediately upon signature by the President on August 8, 2005. Before enactment of the EPAct, the NRC did not have authority over NARM or regulations in place that would specifically apply to this material. Nonetheless, persons engaged in activities involving NARM could be, and States seeking to continue regulation of NARM would be, in technical violation of the AEA.

Section 651(e)(5) of the EPAct authorized the Commission to issue a waiver of the requirements of Section 651(e) to any entity with respect to NARM for specified periods of time if the Commission determined that the waiver was in accordance with the protection of the public health and safety and the promotion of the common defense and security. The Commission determined that there was no basis to conclude that these materials would not continue to be used in a manner that is protective of public health and safety while the waiver is in effect. The Commission also determined that it would be in the best interest of the public to allow continued use of NARM, especially for medical purposes, and to allow the States to continue to regulate NARM until the Commission could codify new regulations for these materials.

The Commission believed that granting the waiver would allow the States to continue with their regulatory programs, allow persons engaged in activities involving NARM to continue their operations in a safe manner, and allow continued access to medical radiopharmaceuticals. In addition, it would enable the Commission to work with the States in developing appropriate regulations for NARM and in formulating a sound Transition Plan for implementation of these regulations. It would also provide an opportunity for non-Agreement States that currently do not have Agreement State regulatory programs under Section 274b. of the AEA to consider entering into an agreement with the NRC. The Commission determined that issuance of the waiver would be in accordance with the protection of public health and safety and the promotion of the common defense and security.

The Commission granted a waiver (70 FR 51581; August 31, 2005) from the requirements of Section 651(e) of the EPAct to: (1) All persons engaged in export from or import into the U.S. of byproduct material through August 7, 2006, unless terminated sooner if the Commission determined that an earlier termination was warranted; and except with regard to the requirements of the DOC relating to export of byproduct material; (2) all persons acquiring, delivering, receiving, possessing, owning, using, or transferring byproduct material through August 7, 2009, unless terminated sooner if the Commission determined that an earlier termination was warranted; and (3) all States that had entered into an agreement with the Commission under Section 274b. of the AEA, and States that had not entered into such an Agreement, through August 7, 2009, unless terminated sooner if the Commission determined an earlier termination was warranted, or for an Agreement State if the Commission made certain determinations required by Section 651(e)(5)(B)(ii) of the EPAct.

Stakeholder Involvement in the Rulemaking Process

The NRC took several initiatives in an effort to enhance stakeholder involvement and to improve efficiency during the rulemaking process. With assistance from the Organization of Agreement States (OAS) and CRCPD, the NRC was able to obtain participation of several State representatives in various working groups in the development of the proposed rule. Principals from OAS and CRCPD, representing interests for both Agreement States and non-Agreement States, also participated in the steering committee forming a partnership with the NRC in making rulemaking decisions. In an effort to keep stakeholders informed, the NRC held a public roundtable meeting in early November. In addition, the NRC has met with other Federal agencies to ensure coordination regarding this rulemaking.

The NRC held a public meeting on November 9, 2005, to discuss rulemaking activities to incorporate NARM into its regulatory framework. The public meeting was in a “roundtable” format to allow stakeholders an opportunity to discuss concerns and to enhance interaction among all interested parties on the subject of the NRC regulating NARM. Representatives from other Federal agencies, States, and a broad spectrum of interest groups were invited to participate in the “roundtable” discussion. A transcript of this meeting is available via the NRC's and other related documents are available from (see

FOR FURTHER INFORMATION CONTACT

section of this document.)

Following the public meeting, the NRC received five written comments from interested parties related to the discussion at the meeting and the rulemaking activities. These comment letters were reviewed and considered by the NRC staff in the development of the proposed rule.

In addition to the public meeting, the NRC interacted and met with FDA staff to exchange information regarding the NRC's NARM rulemaking efforts and the FDA's regulations for accelerator-produced drugs. The primary objective of the FDA's regulations is to ensure medical safety, purity, potency, and effectiveness of the drugs, and that of the NRC's regulations is to ensure radiation safety. During the meeting, areas of potential dual regulation were discussed. Because the NRC and the FDA have different missions, the associated regulations are more complementary than duplicative. FDA has published a proposed rule (70 FR 55038; September 20, 2005), “Current Good Manufacturing Practice for Positron Emission Tomography Drugs,” and expects to finalize the rule soon. The FDA's final rule will establish criteria for the production and process/quality controls for the Positron Emission Tomography (PET) drugs in PET centers registered with the FDA.

The NRC hosted a meeting of Federal agency representatives on November 22, 2005, to discuss the development of a definition of

Discrete source

to be added to the NRC's regulations. Agencies represented at this meeting were DOT, DOE, including the National Nuclear Security Administration, Department of

Defense, DOC, EPA, and the U.S. Customs and Border Protection. A draft definition was formulated. This definition formed the basis for the definition in the proposed rule, with only minor changes and text rearrangement for clarity.

The NRC published the proposed rule to establish the regulatory framework for the newly defined byproduct material on July 28, 2006 (71 FR 42952). Thirty-nine comment letters were received. The commenters included a number of States, Federal agencies, professional organizations, universities, medical communities, industries, and individuals.

II. Discussion

A. The New, Expanded Definition of Byproduct Material

Section 651(e) of the EPAct expanded the definition of Byproduct material to include: (1) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after the date of enactment of the EPAct for use for a commercial, medical, or research activity; (2) any material that has been made radioactive by use of a particle accelerator and is produced, extracted, or converted after extraction, before, on, or after the date of enactment of the EPAct for use for a commercial, medical, or research activity; and (3) any discrete source of naturally occurring radioactive material, other than source material, that the Commission, in consultation with the Administrator of the EPA, the Secretary of DOE, the Secretary of DHS, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security, and that is extracted or converted after extraction, before, on, or after the date of enactment of the EPAct for use in a commercial, medical, or research activity. The NRC is revising the definition of

Byproduct material

in 10 CFR Parts 20, 30, 50, 72, 150, 170, and 171 to be consistent with the EPAct. The same revision to the definition of

Byproduct material

was made in a separate rulemaking for 10 CFR Part 110 (April 20, 2006; 71 FR 20336). A different definition for the term

Byproduct material

is used in 10 CFR Part 40, because 10 CFR Part 40 regulations are limited to source material and the tailings or wastes associated with the extraction or concentration of source material. Therefore, 10 CFR Part 40 regulations are not impacted by the EPAct, and the definition of

Byproduct material

in that Part remains unchanged by this rule.

Since the publication of the proposed rule, and after considering the comments on the new definition of byproduct material, the Commission has taken a closer look at the scope of the Commission's jurisdiction over the newly added byproduct material. The EPAct covers discrete sources of radium-226 and accelerator-produced radioactive material that is “produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for commercial, medical, or research activity” (emphasis added). Notwithstanding that a discrete source of radium-226 may have originated from a commercial supplier, the Commission has determined that discrete sources of radium-226 still in control of the military do not constitute “commercial use” under the EPAct, and are therefore, outside the Commission's jurisdiction. Defining “commercial use” to include all material supplied to the military from a commercial supplier would result in virtually all military use of this material to be “commercial use.” This would vitiate any distinction that the EPAct intended to make for military use, as opposed to commercial use, by excluding military use from its coverage.

However, this exclusion from the coverage of the EPAct only applies to a certain type of military use, i.e., NARM used for “military operations.” The term “military operations” covers what is traditionally understood as the military's primary mission for national defense, including warfare, combat, and battlefield missions, and, of course, training for battlefield missions. NARM used, or available for use, for these purposes would be excluded from the coverage of the EPAct and from the coverage of this rule. If the material is intended for use in military operations, it is excluded from the coverage of this rule notwithstanding the fact that it was originally produced by a commercial supplier. In addition, “military operational” material includes material still under the control of the military, i.e., in storage, or material that may be subject to decontamination and disposal.

Other use of NARM by the military would be covered by this rule. Under the Commission's interpretation of the EPAct, NARM, whether discrete sources or accelerator material, that is produced, extracted, or converted for use or has been used, in medical or research activities, or in a manner similar to a commercial activity, e.g., military museums, is covered by the EPAct and this rule. Furthermore, NARM that was used for military operations but is no longer under the control of the military, has been sold, or is in the possession of private individuals, is also within the coverage of this rule.

The NRC intends to interact with the Department of Defense to obtain a common understanding of the uses of radium-226 and accelerator-produced radioactive material by the military to resolve any potential issues regarding the application of the Commission's interpretation of the EPAct in regard to any specific case of military use.

Radium-226

Radium is a chemically reactive, silvery white, radioactive, metallic element with an atomic number of 88 and symbol of Ra. Radium-226, the most abundant and most stable isotope of radium, is formed by the radioactive disintegration of thorium-230 in the decay series starting with uranium-238. Radium-226 can be found in all uranium ores. The half-life of radium-226 is 1599 years. Radium-226 emits alpha particles and gamma radiation and decays to radon gas.

Although radium was discovered in the ore pitchblende by the chemists Marie and Pierre Curie in 1898, no one understood the dangers of radium until later in the twentieth century. Based on radium's properties, especially its ability to stimulate luminescence, industries started manufacturing hundreds of consumer products containing radium. Radium was added to products such as hair tonic, toothpaste, ointments, and elixirs. Radium paint was used in the mid-1900s to paint the hands and numbers of some clocks, watches, doorknobs, and other objects to make them glow in the dark. Glow-in-the-dark watch and clock faces were particularly popular. Most of these uses were eventually discontinued for health and safety reasons, but its wide use in luminescent paints continued through World War II because radium's luminescent glow made aircraft and vehicle dials, gauges, and other instruments visible at night. Many of these early products still remain in the possession of museums and individual collectors. Large inventories of radium-226 luminescent military and aircraft devices remain and periodically turn up in repair shops, and have resulted in contamination incidents.

In more recent times, radium sources were used in industrial radiography and industrial smoke detectors. Currently, radium sources are still being used in some industrial products, such as industrial gauges, that measure certain

physical properties such as moisture and density.

Accelerator-Produced Radioactive Material

Particle Accelerators

A particle accelerator is a device that imparts kinetic energy to subatomic particles by increasing their speed through electromagnetic interactions. Particle accelerators are used to produce radioactive material by directing a beam of high speed particles at a target composed of a specifically selected element, which is usually not radioactive. Nuclei in the target are struck by the high speed particles and undergo a nuclear transformation. A nuclide that is struck is transformed into a different nuclide. By careful selection of the target element, the particles accelerated, and the operating parameters of the accelerator (e.g., beam energy), a resultant proton-heavy nuclide can be produced. Usually the nuclide produced is radioactive and is created for the use of its radiological properties. The process of transforming nuclei from a stable element into a radionuclide is called activation. In some cases, the target is selected so that the accelerator produces a neutron beam that is, in turn, used to activate nuclides that are then used for their radioactive properties. Some particle accelerators are not used to produce radioactive material, but instead the high energy beam produced by the particle accelerator is used directly, for example, to treat cancer patients.

The two basic designs of particle accelerators are linear and circular, also known as cyclotron. In either case, charged particles are injected into the accelerator to form a beam. The beam is accelerated and focused onto the target. In the circular designs, the beam must be directed to travel in a circular shaped path. For all accelerators, the process of accelerating, focusing, and directing the beam is accomplished by a combination of electrically charged structures and magnetic fields in the accelerator. During operation, these internal structures will be struck by particles from the beam and activated incidentally.

Particle accelerators are often classified by the maximum energy of the accelerated particles, expressed in megaelectron-volts (MeV). An electron-volt is the amount of energy imparted to an electron by an accelerating potential of one volt. The small cyclotrons that produce radionuclides used in PET nuclear medicine usually operate at energies of up to about 30 MeV. By comparison, the accelerators used in basic physics research facilities reach energies in excess of 1000 MeV.

For the purposes of this rulemaking, the NRC divided particle accelerators into three groupings: (1) Those that are always operated to intentionally produce radioactive materials in quantities useful for their radioactive properties for a commercial, medical, or research activity; (2) those that are operated to produce only particle beams and not radioactive materials; and (3) accelerators that are used to produce both radioactive materials and particle beams for other uses. Examples of accelerators that are operated to produce only particle beams and not radioactive materials include linear accelerators used for medical treatment of cancer and other health-related conditions. Other examples include the experimental particle physics research colliders used to probe the fundamental properties of nature (as long as that is their only use) and electron microscopes, i.e., particle accelerators that probe the structure of materials at a very small dimension (high magnification). Ion implanters are particle accelerators used to modify the electrical properties of materials in semiconductor fabrication. In these activities, no radioactive material is intentionally created; all activation is incidental to the intended use of the accelerator.

The NRC will regulate the radioactive material both intentionally and incidentally produced by all accelerators that are intentionally operated to produce a radioactive material for its radioactive properties. The NRC will not regulate the incidental radioactive material produced by accelerators that are operated to produce only particle beams and not radioactive materials for use for a commercial, medical, or research activity. For those accelerators that are used to produce both radioactive material and particle beams, the NRC will regulate the intentionally produced radioactive material and all of the incidentally produced radioactive material, including incidental radioactive material produced when the accelerator is operated to produce radioactive material, as well as incidental radioactive material produced when it is operated to produce only a particle beam. The incidental radioactive materials produced in these accelerators are indistinguishable, so both will be considered byproduct material. The NRC believes very few, if any, accelerators are operated in this way.

The EPAct does not give the NRC authority to regulate the possession or use of particle accelerators. The NRC has not adopted any rule regarding the operation of a particle accelerator or the qualification of any person maintaining or operating a particle accelerator. However, nothing in the EPAct directs the NRC to change the policy that radiation safety standards must consider unregulated as well as regulated sources of radiation. The NRC will continue to require any person subject to the dose limits in 10 CFR Part 20 to continue to include the radiation dose from the operation of a particle accelerator in meeting the dose limitations. The NRC is aware that the operation of a particle accelerator may activate materials in the structure of the building and facilities housing the accelerator. The NRC intends to assure the safe decommissioning of particle accelerator buildings and facilities, including the removal and disposal of activated building materials, to assure that the dose limits to members of the public are not exceeded. The decommissioning of these facilities will be required to meet the radiation dose limits in 10 CFR Part 20 Subpart E—Radiological Criteria for License Termination.

The majority of accelerator-produced radioactive material is now created for use in medicine. The NRC is aware of only two operations in the U.S. and a few importers, mostly from Europe and Canada, that are commercial producers of accelerator-produced radioactive material for use in industrial activities. The regulatory approach for manufacturing accelerator-produced radioactive material for industrial purposes is similar to the regulatory approach for manufacturing accelerator-produced radioactive material for medical purposes.

Accelerator-Produced Radioactive Material Used in Medical Activities

Medical use of radioactive material began over 50 years ago. The medical use of sealed and unsealed radioactive materials continues to be an important component of medical specialties for both diagnosis and therapy purposes. The use of small quantities of unsealed radioactive materials (radiopharmaceuticals) in nuclear medicine is an integral part of patient care and is extremely valuable in the early diagnosis and treatment of medical conditions. Radiation oncology uses larger amounts of radioactivity in sealed sources to deliver therapeutic or palliative radiation doses.

Almost all reactor-produced byproduct radionuclides for radioactive drugs are imported into the U.S., as well as most reactor-produced radionuclides used in sealed sources, although some used in radioactive drugs and sealed

sources are also produced in an NRC-regulated nonpower reactor. Commercial manufacturers primarily use the imported radionuclides to produce specific sealed sources, radioactive drugs, and biologics. Commercial nuclear pharmacies may use radiochemicals to prepare radioactive drugs, as well as commercially produced radioactive drugs and drug sources, such as molybdenum-99/technetium-99m generators, to prepare unit dosages of other radioactive drugs.

The U.S. has a limited number of commercial radionuclide production facilities that use accelerators to produce radionuclides, such as thallium-201, iodine-123, indium-111, and gallium-67 used in radioactive drugs. A larger number of radionuclide production facilities (often referred to as PET centers) use cyclotrons to produce the PET radionuclides fluorine-18, carbon-11, nitrogen-13, and oxygen-15 for use in PET radioactive drugs. PET radionuclides decay by positron emission and, because of their relatively short half-life (minutes to hours), are produced at locations in close proximity to the patients (e.g., in hospitals or academic institutions) or at nearby locations.

Palladium-103, the most common accelerator-produced medical use radionuclide contained in a sealed source, was originally produced at reactor facilities. Other radionuclides used in medical radiation therapy can also be produced with either reactors or accelerators. With the new definition of

Byproduct material

, sealed sources that can be produced from either pathway will be uniformly regulated. At this time, there are no teletherapy or remote afterloader or gamma stereotactic radiosurgery units with accelerator-produced sources.

Because production accelerators for medical radionuclides (e.g., PET production facilities) and industrial radionuclides are used to intentionally produce radioactive material for use of its radioactive properties for a commercial, medical, or research activity, the NRC will regulate both the radionuclides produced in these accelerators as well as the incidentally activated radioactive material.

Other Naturally Occurring Radioactive Material With Similar Risk as Radium-226

The EPAct amended the definition of

Byproduct material

to include any discrete source of naturally occurring radioactive material, other than source material, that the Commission, in consultation with the Administrator of the EPA, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security, and is extracted or converted after extraction, before, on, or after the date of enactment of the EPAct for use in a commercial, medical, or research activity.

The inclusion of discrete sources of naturally occurring radioactive material into the definition of

Byproduct material

is contingent on the Commission's determination, in consultation with other Federal agencies, that these discrete sources would pose a threat similar to the threat posed by a discrete source of radium-226. The NRC has not currently identified any discrete sources of naturally occurring radioactive material under this provision, and the rule does not contain criteria for making such a determination. For comparison, the International Atomic Energy Agency (IAEA) has identified a list of sources that are considered to pose a high risk to human health and safety if not managed safely and securely. The IAEA Code of Conduct on the Safety and Security of Radioactive Sources (Code of Conduct) identified certain quantities of 26 radionuclides that pose a significant risk to individuals, society, and the environment. The activity of these radionuclides at the IAEA Code of Conduct Category 1 or 2 level could be fatal or cause permanent injury to a person who handled them or was otherwise in contact with them for a short time, if not safely managed or securely protected. Of these 26 sources, only two naturally occurring radionuclides are listed: Radium-226 and polonium-210. Because this rule addresses discrete sources of radium-226, the only other naturally occurring radioactive material similar in hazard to radium-226 when using the IAEA criteria is polonium-210. However, naturally occurring polonium is scarce. One ton of uranium ore contains only about 100 micrograms (0.0001 grams) of polonium. Due to its scarcity in nature, polonium-210 used for commercial purposes is usually produced by bombarding bismuth-209 with neutrons in a nuclear reactor and had been regulated by the NRC before the EPAct. Additionally, polonium-210 is unlikely to be commercially used in individual radioactive sources with activity levels that would place them within the IAEA Code of Conduct Category 1 or 2. Hence, the NRC has determined that no other discrete sources of naturally occurring radioactive material pose a threat similar to the radium-226-level or IAEA Code of Conduct Category 1 or 2 sources.

Through interaction with other Federal agencies and States during development of the rule, the NRC concluded that, at this time, only polonium-210 has the potential to pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security. The NRC had already been regulating the use and possession of polonium-210 because it is produced in nuclear reactors and is rarely extracted as naturally occurring radioactive material. Therefore, although this rule adds this category of byproduct material to the definitions in the regulations, at this time, the NRC's regulations will not apply to any discrete sources of naturally occurring radioactive material, other than radium-226. The EPAct has provided a mechanism for the Commission to include additional discrete sources of naturally occurring radioactive material in the future following consultation with other Federal agencies, if the need arises to consider other naturally occurring radioactive material as byproduct material. No further revision to the regulations will be necessary to begin regulating a material identified through this mechanism. However, the NRC will provide an opportunity for public input before applying its regulations to other naturally occurring radionuclides that the NRC determines in consultation with other federal agencies, pose a threat similar to the threat posed by discrete source of radium-226.

B. The NRC's Regulatory Approach

Consideration of Suggested State Regulations for the Control of Radiation (SSRs)

All 34 Agreement States have regulations for NARM. Twelve non-Agreement States and certain U.S. Territories have some type of regulatory structure for NARM, while four non-Agreement States have no program for regulating NARM. The EPAct mandated that the NRC use model State standards to the maximum extent practicable in issuing regulations for the expanded definition of

Byproduct materia

l. The NRC considered the SSRs published by CRCPD (

http://www.crcpd.org/free_docs.asp

) as the model State standard in developing this rule. Most Agreement States have regulated discrete sources of radium and accelerator-produced radioactive

material in a manner similar to and under the same requirements as reactor-produced radioactive material. Few provisions in the SSRs exist solely to address these materials. Where specific provisions do exist in the SSRs for these materials, they have been evaluated for possible inclusion in the NRC's regulations.

For radionuclide-specific values listed in 10 CFR part 20, Appendices B and C, the NRC found that there are no other radionuclides identified in the SSRs that are not already included in 10 CFR part 20. As discussed further in this document under Section C., “Changes to Existing NRC Regulations to Accommodate the New Byproduct Material,” most of the specific provisions related to NARM radionuclides in the SSRs have been adopted in this rule. These include exempt quantities in 10 CFR 30.18 and 10 CFR 30.71, an exemption for timepieces in 10 CFR 30.15, a general license for calibration and reference sources in 10 CFR 31.8, a general license for use of radioactive material for certain in vitro clinical or laboratory testing in 10 CFR 31.11, contamination limits for strontium-82/rubidium-82 generators, and requirements to measure the contamination limits in 10 CFR 35.204 with corresponding recordkeeping requirements in 10 CFR 35.2204.

While SSRs do exist that address other types of naturally occurring radioactive material that are not covered by the EPAct or these new regulations, discrete sources of radium and accelerator-produced radioactive material are covered under the same provisions of the SSRs that apply to reactor-produced radioactive material. There is general agreement among the States, reflected in the SSRs, that the new categories of byproduct material should be regulated under the same requirements as reactor-produced radioactive material. This rule takes the same regulatory approach. Most of the requirements that will apply to users of the newly regulated material are preexisting NRC requirements.

Other Related Rulemakings

The NRC amended its regulations in 10 CFR Part 110 revising the definition of

Byproduct material

to include discrete sources of radium-226, accelerator-produced radioactive material, and discrete sources of naturally occurring radioactive material (71 FR 20336; April 20, 2006). In addition, an earlier amendment (70 FR 37985; July 1, 2005) added discrete sources of radium to 10 CFR Part 110, Appendix P. Together, the two amendments satisfy the requirements of Section 651(d) of the EPAct pertaining to the export or import of Category 1 or Category 2 radiation sources as defined by the IAEA Code of Conduct. By this final rule, the NRC is again amending is regulations in 10 CFR Part 110 to include a definition of

Discrete source

.

Section 651(d) of the EPAct also requires the NRC to issue regulations establishing a mandatory tracking system for radiation sources, including radium-226, in the U.S. The NRC issued a final rule for national source tracking of sealed sources (71 FR 65686; November 8, 2006) that included radium-226 sources.

Definition of Discrete Source

The EPAct extended the definition of

Byproduct material

in the AEA to include any discrete source of radium-226 and certain other naturally occurring radioactive material that is produced, extracted, or converted after extraction, before, on, or after the date of the enactment of the EPAct, for use for a commercial, medical, or research activity. The term

Discrete source

is not defined in the EPAct, and the EPAct specifically mandates that the final regulations, in establishing requirements necessary to carry out the amendment, shall include a definition of the term

Discrete source

. The definition of

Discrete source

is used for purposes of the new definition of

Byproduct material

in the case of radium-226 and other naturally occurring radioactive material other than source material. The term

Discrete source

is not used in conjunction with accelerator-produced radioactive material in the EPAct language.

Thus, the EPAct gave the NRC authority over discrete sources of radium-226 but not over diffuse sources of radium-226. The EPAct did not extend the NRC's authority over radium-226 as it occurs in nature, or over other processes where radium-226 may be unintentionally concentrated. The focus was on those materials that presented a threat to public health and safety or to the common defense and security similar to the threat posed by discrete radium-226 sources. Scale from pipes used in the fossil fuel industry, fly ash from coal powerplants, phosphate fertilizers, or residuals from treatment of water to meet drinking water standards are not considered discrete sources. However, uranium and thorium within these materials may become licensable source material depending upon their concentration.

The definition of

Discrete source

in the proposed rule was “a radioactive source with physical boundaries, which is separate and distinct from the radioactivity present in nature, and in which the radionuclide concentration has been increased by human processes with the intent that the concentrated radioactive material will be used for its radiological properties.” As a result of public comments on the proposed rule, the NRC changed the wording of the definition of

Discrete source

from that in the proposed rule.

Discrete source

is defined in this final rule 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.” The changes are for clarification purposes only and do not change the original intent of the proposed definition of

Discrete source

or the scope of the NRC's regulation of radium-226 or other naturally occurring radioactive materials identified in the future. The intent of the revised definition continues to be consistent with the proposed rule in that the NRC's authority is not intended to extend to all naturally occurring radioactive material, specifically not to naturally occurring radioactive material that is found in nature in its original form and location, or that which is moved or concentrated inadvertently by some man-made process. A discrete source will have the same radiological characteristics (e.g., type of radiation, half-life) as the radionuclide found in nature but will have been purposefully concentrated for use for its specific properties after it has been removed from its original location in nature. This definition excludes the NRC's jurisdiction over inadvertent movement or concentration of naturally occurring radioactive material such as scale from pipes used in the fossil fuel industry, fly ash from coal power plants, or phosphate fertilizers. It also excludes NRC jurisdiction over residuals from treatment of water. While radium, in particular, may be intentionally concentrated in this case, it is not for the purpose of using the radium, but to improve water quality. Only if, and when, this radium were further processed for use would it be considered a discrete source, and thus byproduct material. Neither the changes to the AEA as a result of the EPAct, nor anything in this rulemaking changes the NRC's authority, in any manner, over source material.

The words “a radionuclide that has been processed so that its concentration within a material has been purposely increased” are intended to further clarify that the extraction or processing relates to the intent to use the radionuclide itself, and not a material

that happens to contain the radionuclide, such as fertilizer. The addition of the phrase “for use for commercial, medical, or research activities” repeats a constraint that also appears in the definition of

Byproduct material

. The NRC has repeated this constraint in order to ensure that when the term “discrete source” is used separately from the term “byproduct material,” it will not be interpreted more broadly, but it will be clear that only material which is intended for use for commercial, medical, or research activities is being referenced.

It should also be noted that in accordance with this definition of

Discrete source

, once a discrete source meets the definition of

Byproduct material

, any contamination resulting from the use of such discrete sources of this byproduct material will also be considered byproduct material. This issue is discussed further in this document under “Summary and Analysis of Public Comments on the Proposed Rule.”

C. Changes to Existing NRC Regulations To Accommodate the New Byproduct Material

The Commission has authority to issue both general and specific licenses for the use of byproduct material and to exempt byproduct material from regulatory control under Section 81 of the AEA. A general license, as provided by regulation, grants authority to a person for certain activities involving byproduct material and is effective without the filing of an application with the Commission or the issuance of a licensing document to a particular person. Requirements for general licensees appear in the regulations and are designed to be commensurate with the specific circumstances covered by each general license.

In considering the expansion of the definition of

Byproduct material

to include discrete sources of radium-226 and accelerator-produced radioactive material, the NRC has evaluated products and materials previously approved by the States for use under an exemption from licensing and under a general license. Generally, the NRC's intent in this rule is to accommodate existing products and materials that were previously regulated by the States under similar provisions, if the potential doses are similar to those expected from other currently regulated products and materials. Many of these products have not been made for some time, so some of the provisions in this rule are limited to items manufactured in the past, which may still be in use or in storage.

The bases of these exemptions and general licenses are primarily the SSRs and also information in NRC's sealed source and device (SS&D) registry. The SS&D registry is the NRC's national database of technical information on sealed sources and devices. Manufacturers or distributors may submit a request to the NRC for an evaluation of a product's radiation safety information and for registration of the product. After satisfactory completion of the evaluation, the NRC issues a certificate of registration to the person making the request, and this certificate is added to the SS&D registry. Many Agreement States have similar registration procedures, and registration certificates for the sources and devices they review are added to the national SS&D registry. The NRC also has included SS&D certificates for NARM, which have been issued by the States. While this is not a complete database with respect to NARM, it includes detailed information about many products containing NARM previously evaluated by the States. In addition to SSRs and the information in the SS&D registry, the specific provisions of the various States also were considered in developing this rule.

Regulating Items Containing Radium-226

Currently, items or products containing radium-226 are unique in that there are no new items in consumer commerce using radium-226 byproduct material. Although 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. Beginning in the early 1900s, radium-226 was used to make self-luminescent paint and incorporated in watch and clock dials and hands and later used to illuminate airplane instrumentation dials and gauges as well as markers and signs. Beginning in the 1950s, other radionuclides began to replace radium-226 as a self-luminescent material due to the recognition of the radiological hazard associated with radium-226. Currently, the radionuclides of choice for self-luminescent applications are promethium-147 and tritium due to the much reduced radiological hazard vis-a-vis radium-226.

Based on the National Council on Radiation Protection and Measurements in Report 95, “Radiation Exposure of the U.S. Population from Consumer Products and Miscellaneous Sources,” radium-226 has not been used in radioluminescent watches since 1968 and clocks since 1978. In fact, radium-226 timepieces are currently kept largely as collectors' items and only infrequently used by consumers as timepieces. When originally manufactured, the quantity of radium-226 employed in watch and clock dials and hands varied by timepiece size, manufacturer, model, and from item to item. While the quantity of radium-226 varied in the timepieces, there is a general agreement for typical average and upper bound quantities. Based upon the spectrum of timepiece sizes, wristwatches have the smallest quantity, with pocket watches and clocks having quantities several times higher than wristwatches. The radioactivity associated with wristwatches is generally on the order of several kilobecquerel (kBq) (tenths of a microcurie (μCi)) with an average of 5.6 kBq (0.15 (μCi)). Pocket watches may have radioactivity of about 13 kBq (0.35 μCi), and clocks are typically 18 kBq (0.5 μCi). However, collections of pocket watches and clocks are rare when compared to wristwatches.

Before the discontinuation of the manufacturing of timepieces containing radium-226 in the 1970s, radium-226-illuminated timepieces were widely distributed throughout the country as a common consumer product. To date, a large number of radium-226 timepieces are still owned by individuals as valued heirlooms or collectors' items or are on display in museums. Because museums and collectors normally collect a wide range of timepieces, a portion of their collection may contain radium-226 timepieces. Some businesses and a few collectors are also engaged in repairing and refurbishing timepieces either as a hobby or professionally, and these activities may occasionally involve timepieces containing radium-226. Because these timepieces were manufactured before the NRC assumed regulatory authority over radium-226, and because these timepieces are already in public possession, the NRC intends to minimize regulatory impact to individuals, museums, or other entities in possession of these timepieces. In finalizing the rule, the NRC made its determination based on no significant risk to public health and safety and the environment.

In the proposed rule, the NRC proposed to exempt intact timepieces containing no more than 37 kBq (1 μCi) of radium-226 per timepiece and repair of no more than 10 timepieces in any one year. In addition, the NRC proposed to generally license no more than 50 timepiece hands and dials used or stored at the same location at any one time. Due to lack of sufficient health and safety information to make a final regulatory decision, the NRC conducted

a scoping study for estimating potential radiological doses to individuals associated with use, storage, and repair of radium-226 timepieces. The scoping approach taken by the NRC used widely accepted methods and employed conservative assumptions for various scenarios involving use, storage, and repair of radium-226 timepieces. Because the scoping study was designed to be conservative and meaningful and yet easy to perform, it is to be expected that the actual doses would be significantly lower than those predicted by the scoping study.

To evaluate the potential doses associated with the proposed exemption of radium-226 timepieces, 37 kBq (1 μCi) of radium-226 per timepiece was used in the scoping study instead of the typical average activities for timepieces, which provided for additional conservatism. Radon-222 is a decay product in the radium-226 decay series and may be emitted from the timepiece into the surrounding atmosphere and thus result in exposure to an individual in proximity to the timepiece. It is believed that the radon-222 emanating from the paint is almost totally trapped within the watch. Because of the age of radium-226 timepieces, and because there is no established method for quantifying the trapping behavior, the scoping study conducted by the NRC assumed that the entire inventory of decay products instantly escaped and became uniformly distributed into the surrounding building volume. This assumption is obviously very conservative. As a result, the estimated inhalation doses associated with radon-222 are extremely conservative. The scoping study found that the estimated doses to a collector for repair, storage, and use of a radium-226 timepiece range from a fraction of 0.01 millisievert/yr (mSv/yr) [1 millirem/yr (mrem/yr)] to a few mSv/yr (mrem/yr) to over 1 mSv/yr (100 mrem/yr).

At one time, there were repair facilities refurbishing radium timepieces on a regular basis by replacing radium-226 paint with tritium paint. Scraping off the radium-226 paint may have resulted in significant contamination. The NRC is not aware of any current operations in which individuals are still routinely handling radium watches in such a way as to create a contamination problem. Based upon the estimated doses for repairs, the NRC believes that a specific limit on the annual number of repairs is not necessary. As long as these repairs are taking place under a general license, actions could always be taken if the Commission receives information that suggests that the public health and safety are not being adequately protected.

The NRC's intent is to minimize regulatory impact on those private collectors and museums as much as possible, and to be as consistent as possible with the regulatory approach taken by the Agreement States, many of whom have been regulating radium-226 for several decades. Accordingly, in light of the public comments received, the Agreement States' rulemaking involvement and the results of the scoping study in finalizing the rule, the NRC revised the proposed revisions related to radium-226 timepieces. Primarily, the change made in this final rule is to broaden the general license provision for the radium-226 timepieces. Specifically, the NRC has concluded that a finite number of annual repairs as well as a limitation on the number of nonintact timepieces and timepiece hands and dials is unnecessary and not warranted based upon the NRC's understanding of radium-226 timepieces either in collections or in use. As a result of the scoping study and in response to public comments, the NRC has concluded that it is appropriate to recategorize the repair of timepieces from an activity allowed under an exemption from licensing to one covered by a general license. This categorization is also more consistent with the Agreement States' existing exemption provision.

Although not mandated by regulations, the NRC advises that individual collectors or persons engaged in repair of these devices should use good practices such as wearing gloves when handling radium-226 timepieces, hands, and dials, and washing hands to minimize potential exposure to the radioactive material. In addition, individual collectors should ensure that storage areas are well ventilated to minimize potential exposure due to accumulation of radon-222 gas and should avoid unnecessary exposure to these types of timepieces.

Exemptions From Licensing

In 10 CFR Part 30, a number of exemptions from licensing requirements are included. These exemptions allow for certain products and materials containing byproduct material to be used without any regulatory requirements imposed on the user. The two exemptions in 10 CFR 30.19, Self-luminous products containing tritium, krypton-85, or promethium-147, and 10 CFR 30.20, Gas and aerosol detectors containing byproduct material, are class exemptions which cover a broad class of products. Under these provisions, new products can be approved for use through the licensing process if the applicant demonstrates that the specific product is within the class and meets certain radiation dose criteria. This contrasts with other exemptions for which the level of safety is controlled through such limits as specification of radionuclides and quantities. Section 30.14, Exempt concentrations, and Section 30.18, Exempt quantities, of NRC's regulations, are broad materials exemptions, which allow the use of a large number of radionuclides. The specific radionuclide limits on these concentrations and quantities are contained in tables in 10 CFR 30.70 and 10 CFR 30.71, respectively. The remaining exemptions from licensing are product specific, for which many assumptions can be and have been made concerning how the product is distributed, used, and disposed of. This final rule adds some products and materials containing NARM to some of the previously existing exemptions. The table of exempt concentrations in 10 CFR 30.70 already included all of the radionuclides and associated limits contained in the equivalent section of the SSRs. Thus, the NRC is not revising the exempt concentration table in this final rule.

Exempt Quantities

Part C of the SSRs includes a list of exempt quantities which are identical to those in 10 CFR 30.71 but includes an additional 13 radionuclides, which are accelerator produced. This final rule adds these 13 radionuclides and their respective quantities, as already included in the SSRs, to the list of exempt quantities in 10 CFR 30.71. The technical bases of these values are similar to those used for the existing values in 10 CFR 30.71.

The NRC considered whether there were additional radionuclides in use under comparable State exemptions that should be accommodated under 10 CFR 30.71. It was noted that a few of the States' regulations for exempt quantities include additional radionuclide-specific values, each appearing in only one or two States' regulations. These radionuclides are specifically exempted in only one or two States; thus, they do not represent nationally recognized exemptions. It was also not clear as to what approach was used to calculate their exemption values. Therefore, the NRC is adding only the 13 radionuclides and values from the SSRs for which there are adequate technical bases, and no further additions to 10 CFR 30.71 are included in this final rule. It is noted, however, that for other byproduct material, excluding alpha emitters, which is the last item on the list in 10

CFR 30.71, Schedule B allows for 3.7 kBq (0.1 μCi) to be used as an exempt quantity. This will apply to accelerator-produced radionuclides as well. Minor changes are also being made to 10 CFR 30.18 to accommodate any materials that may have been received before September 25, 1971, under a general license of a State similar to that then provided in 10 CFR 31.4.

Timepieces Containing Radium-226

The exemption in 10 CFR 30.15(a)(1) is being revised to include intact timepieces that were manufactured before the effective date of this final rule and containing no more than 37 kBq (1 μCi) of radium-226. This provision is consistent with the SSRs, except that the rule is limited to “intact” timepieces. In the final rule, the repair of timepieces was moved from the exemption to the general license to be more consistent with the SSRs and to broaden the general license provision. As discussed earlier, the possession of nonintact timepieces, hands, and dials, and the repair of timepieces would be covered by a new general license. This general license provision should cover most current practices involving radium-226 and minimize impacts upon individual collectors and small businesses. A general license is automatically granted by NRC regulations to any person meeting the general license criteria. No action is required from these persons to obtain a general license, and no license or annual fees are applicable to persons operating under this general license.

Self-Luminous Products

Although the SSR section similar to 10 CFR 30.19 includes an exemption for previously acquired self-luminous articles containing less than 3.7 kBq (0.1 μCi) of radium-226, 10 CFR 30.19 is not being amended to include this exemption. The basis for not including this exemption is that, as currently written, 10 CFR 30.19 only applies to products manufactured and distributed under a specific license issued under 10 CFR 32.22. The SSR exemption does not require that these products be previously manufactured and distributed under a specific license, nor do the SSRs provide for such a license with regard to radium-226. Instead, the possession, use, and transfer of these items will be subject to the general license for certain items and self-luminous products containing radium-226 established in 10 CFR Part 31.

Smoke Detectors

Smoke detectors are included in the class exemption in 10 CFR 30.20 for gas and aerosol detectors. This exemption is being revised to include previously manufactured detectors containing radium-226. The provision for smoke detectors is different from the SSRs in that the SSRs contain a specific limit of 3.7 kBq (0.1 μCi) for radium-226 that manufacturers may incorporate into the currently manufactured detectors. However, the SS&D registry includes certificates for smoke detectors categorized as exempt containing up to 74 kBq (2 μCi) of radium-226. While some of these certificates are categorized as “Active,” meaning that continued distribution is permitted, a survey of the States with these certificates confirmed that the distribution of radium-226 in smoke detectors was, in fact, a past practice. The provision added to 10 CFR 30.20 for detectors containing radium-226 is limited to detectors previously manufactured and distributed under a specific license issued by a State under comparable provisions to 10 CFR 32.26. Thus, similar standards were used in approving distribution of these detectors for use under an exemption from licensing. This exemption does not cover smoke detectors manufactured earlier with larger quantities of radium-226 and authorized for use under a general or specific license, or smoke detectors that may not have been distributed under a specific license.

Distribution to Exempt Persons

The NRC retains the authority for authorizing distribution of products and materials where the end user is exempt from licensing and regulatory requirements by regulation in 10 CFR 150.15(a)(6), which states, in part, that persons in Agreement States are not exempt from the Commission's licensing and regulatory requirements with respect to the transfer of possession or control of any equipment, device, commodity, or other products containing byproduct material to persons who are exempt from licensing and regulatory requirements of the Commission. The NRC does not transfer this authority when a State enters into an Agreement with the NRC. Therefore, persons who initially transfer products containing byproduct material to persons who are exempt from licensing must have a license from the NRC authorizing these activities. These distributors also need a specific license from either an Agreement State or from the NRC authorizing the possession and use of the byproduct material. As a result of the expansion of the definition of

Byproduct material

, the distribution of NARM to exempt persons, including distribution by licensees in Agreement States, will also be authorized only by the NRC. Currently, the States have only a few licensees authorized to distribute to persons exempt from licensing requirements. These are for exempt quantities of accelerator-produced radioactive material. In finalizing this rule, the NRC has determined that most, if not all, of these distribution licensees already have an NRC license under 10 CFR 32.18 authorizing the distribution of exempt quantities of pre-EPAct byproduct material. For these distribution licensees, only a simple amendment of those NRC licenses will be required as a result of this aspect of this final rule.

Existing General Licenses

General License for Devices in 10 CFR 31.5

Section 31.5 is the primary general license provision in 10 CFR Part 31. It covers a broad range of devices “designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.” These devices must be distributed under specific licenses issued under 10 CFR 32.51 or equivalent regulations of an Agreement State. There are numerous SS&D certificates for devices containing NARM that have been approved by the States for use under a general license. These are almost all for devices containing cobalt-57, sodium-22, or radium-226. In many cases, models have been approved which are authorized to contain one of these radionuclides or one or more other radionuclides that were byproduct material before the EPAct. They have been evaluated under equivalent, in most cases, or at least comparable, standards by the States. The rule will accommodate generally licensed devices meeting the restrictions of the general license that were previously approved by the States under comparable provisions to 10 CFR 32.51. Active certificates would stand with amendments, if needed, being made to the distributors' licenses to cover the new categories of byproduct material. Any new certificates would be issued by the NRC or the Agreement States under the AEA encompassing the new definition of

Byproduct material

.

The criteria for registration of generally licensed devices under 10 CFR 31.5(c)(13)(i) are revised to include a criterion for registration by general licensees of devices containing 3.7 megabecquerels (MBq) (0.1 millicurie (mCi)) or more of radium-226. This

registration process is separate and quite different from the SS&D registry. It requires physical inventories and certification of device information by general licensees, allows the NRC and Agreement States with equivalent regulations to more fully track generally licensed devices meeting these criteria, and serves to remind general licensees of their responsibilities under the general license. SS&D certificates for generally licensed devices that will now come under 10 CFR 31.5 include devices with more than 3.7 MBq (0.1 mCi) of radium-226. These devices will be subject to the registration requirement in 10 CFR 31.5(c)(13). Other certificates, which include devices with radium-226, allow only much smaller quantities. These devices will not be required to be registered. This criterion for registration of radium-226 was chosen because of the low concentration levels which typically are required for decontamination and decommissioning involving radium-226, as well as the relative dispersibility of radium-226. A principal purpose of the registration process concerns reducing losses of devices that could significantly contaminate a smelter, if inadvertently melted. The NRC does not believe there are accelerator-produced materials used in significant quantities in these types of generally licensed devices to warrant registration.

Distributors of NARM have typically also been distributors of pre-EPAct byproduct material. Many of them have not excluded information about transfers of devices containing NARM from reports of transfers made to the NRC on generally licensed devices transferred into the NRC jurisdiction. Therefore, the NRC already has information on some of these devices in its general license tracking system. The NRC will work with the States to examine methods to include State information. It is expected that the registration process will identify additional devices containing registrable quantities of radium-226, as users in many cases will already be registering other devices with the NRC containing other radionuclides and will need to add devices containing radium-226 during the registration process. The requirements in 10 CFR 32.51, 32.51a, and 32.32 applicable to the manufacture or initial transfer of these devices did not need revision to accommodate NARM.

Calibration and Reference Sources in 10 CFR 31.8

Section 31.8 provides a general license for the use of up to 185 kBq (5 μCi) of americium-241 in calibration and reference sources. This final rule adds radium-226 to 10 CFR 31.8, consistent with the SSRs. This general license is only applicable to specific licensees that have calibration and reference sources as defined in 10 CFR 31.8, and simply eliminates certain administrative requirements to address these sources under the specific license. The sources are covered by requirements applicable under the specific license, as well as additional requirements in 10 CFR 31.8. The requirements in 10 CFR 32.57, 32.58, 32.59, and 32.102 applicable to licenses to manufacture or initially transfer these sources are also amended to include radium-226.

General License for In Vitro Test Kits in 10 CFR 31.11

In keeping with the equivalent section of the SSRs, cobalt-57, in units not exceeding 370 kBq (10 μCi) each, is added to the general license in 10 CFR 31.11 for use in certain in vitro clinical or laboratory testing. Also, the requirements in 10 CFR 32.71, which provide the licensing criteria for the manufacturer and distributor of the products used under this general license, are revised to apply to the cobalt-57 products included in the general license.

New General License for Certain Items and Self-Luminous Products Containing Radium-226

The Commission specifically requested information on the types and quantities of products containing radium-226 and any information that could assist the NRC in more fully evaluating the potential impact to public health and safety and the environment due to activities involving radium-226 sources. As discussed earlier, the general license provisions for radium-226 timepieces were changed to remove, from the proposed rule, a limitation on the number of timepieces that could be possessed. In response to public comment, the general license provision within this section for luminous gauges and other luminous products containing radium-226 was also changed with respect to the categories of products covered and the numbers of products allowed to be kept at any one location. This is discussed in this document under the section, “Summary and Analysis of Public Comments on the Proposed Rule.” Because 10 CFR 31.2 delineates the applicability of specific provisions in 10 CFR part 30 to the general licenses of 10 CFR part 31, an exemption from the reporting and recordkeeping requirements of 10 CFR 30.50 and 30.51 is added to further reduce the regulatory burden on stakeholders. Furthermore, because many of the circumstances that would require reporting under 10 CFR 30.50 are unlikely to occur, the NRC believes that it is unnecessary to apply these requirements to this general license and that the reporting requirements in 10 CFR 31.12 are adequate.

The new section added to 10 CFR part 31 provides a general license to any person for other products and discrete sources containing radium-226 that are not exempted, and are apparently in the public domain, but were not otherwise covered under a license and are not specifically addressed in the SSRs. The general license includes: (1) Antiquities originally intended for use by the general public and distributed in the late 19th and early 20th centuries, such as radium emanator jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads; (2) Nonintact luminous timepieces and timepiece hands and dials not contained in timepieces; (3) Luminous gauges and other items containing radium-226 installed in air, marine, or land vehicles (These include airplanes, helicopters, jeeps, trucks, tanks, ships, landing vessels, artillery pieces, and any other former military use vehicle no longer in control of the military.); (4) All other luminous products, provided that no more than 100 are used or stored at the same location at any one time; and (5) Small radium sources containing no more than 37 kBq (1 μCi) of radium-226 as discrete survey instrument calibration sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers, and spinthariscopes), electron tubes, lightning rods, ionization sources, and static eliminators. As discussed earlier, this general license allows any person to acquire, receive, possess, use, or transfer radium-226 contained in the previously mentioned products. Persons who receive, possess, use, or transfer the radium-226 items under the general license are exempt from the provisions of 10 CFR parts 19, 20, 21, and 10 CFR 30.50 and 30.51 to the extent that the receipt, possession, use, or transfer is within the terms of the general license.

The general license prohibits the manufacture, assembly, disassembly, repair, or import of products containing radium-226 except for the repair of timepieces; prohibits export under the general license; and requires that the product only be disposed of by transfer to a specific licensee authorized to receive it or to a disposal facility

authorized to dispose of the material in accordance with any Federal or State solid or hazardous waste law. The general license also prohibits abandonment of the product. The general license requires notifying the NRC if there is any indication of a possible failure of, or damage to, the product that could result in a loss of the byproduct material and requires persons possessing these devices under the general license to respond to written requests for information from the NRC.

It should be noted that 10 CFR 31.2 delineates the terms and conditions of 10 CFR part 30 which apply to general licensees. These provisions generally will not require general licensees to initiate any actions.

It is the NRC's intent, through the general license provision, that the Agreement States, to a large extent, will be able to maintain the existing “status quo” in regulating these categories of discrete sources of radium-226. The Agreement States may continue with their programs, including requiring a specific Agreement State license or decommissioning plan when larger numbers of products may be involved or significant contamination of property has resulted.

Specifically Licensed Sealed Sources and Devices

Registration of Safety Information and Licensing of Sealed Sources and Devices

The NRC is revising 10 CFR 30.32(g) to allow for the specific licensing of sealed sources and devices containing NARM that were previously regulated by the States. Sources and devices registered by the States may be licensed under 10 CFR 30.32(g)(1), and the user is only required to provide the manufacturer and model number as registered in the SS&D registry.

A new paragraph (3) is also being added to 10 CFR 30.32(g) to allow for the licensing of sealed sources and devices containing NARM for which all of the information otherwise required is not available. This second provision has been added in this final rule as a result of public comment. Previously, if a source or device were not registered in the SS&D registry, the applicant who wanted to use the source or device would be required to submit all of the safety information identified in 10 CFR 32.210(c), because this information had not been submitted previously by the manufacturer or distributor as part of registering the source or device. For older “legacy” devices for which the manufacturer is no longer in existence, it may be impossible to provide all of the categories of information identified in 10 CFR 32.210, as required by 10 CFR 30.32(g)(2). The provision being added as 10 CFR 30.32(g)(3) delineates additional information that will be required to license a source or device for which all of the information previously required is not available. The information must include a description of the source or device, a description of radiation safety features, intended use and associated operating experience, and results of a recent leak test. The NRC licensing staff will review the submitted information to make a licensing decision regarding possession and use of the source and device. This new provision is only applicable to sources and devices containing NARM manufactured before the effective date of this final rule.

The information to be provided must demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. The amount of detail needed to make this finding will depend on such things as the nature of the source or device and the amount of information identified in 10 CFR 32.210(c) that is available. However, generally, the source or device description might include the radionuclide(s), source activity, chemical and physical form, manufacturer's name, distributor's name, model number, construction details such as source or device dimensions, source encapsulation, any labeling, and a radiation profile. A description of device radiation safety features might include shielding, on-off mechanisms or indicators, methods for locking beam shutters, any safety warning labels, type of installation including method of attachment to its mounting if installed in a fixed location and means of relocation if portable, and any automatic safety features. The description of the intended use of the source or device could include how the source or device is used, the types of users, the locations of use, the occasions when persons will be near the device and the frequency of these occasions, and the likely environments to which the source or device will be subjected during normal use and likely accident conditions. A description of associated operating experience using the source or device should describe how the device has been used, particularly if the device will be used in this manner in the future, should include routine maintenance procedures and how frequently performed, should note any operating problems and their resolution, and should identify any parts that were repaired or replaced. A description of a recent leak test should identify when the swipe was taken and evaluated and describe how the leak test swipe was taken, the results, and who conducted the evaluation.

Applicants are not authorized to remove sources from a device to obtain source details, unless qualified and specifically authorized to perform these activities under a license. For “uncontained” sources, applicants will need to use caution and minimize exposure time when attempting to gather details or information directly from the source.

Regulating the Accelerator-Produced Radioactive Material Used in Medical Activities

When reviewing the public comments, it was clear that the discussion in the proposed rule of the NRC's existing regulatory framework for medical products, the distinction between radionuclide production licensing and radioactive drug production licensing, and the commercial and noncommercial distribution provisions, as well as the introduction of the term “consortium,” were confusing to commenters. In addition to responding to individual comments on these subjects in the “Summary and Analysis of Public Comments on the Proposed Rule” section of this document, the following discussion is provided to give a clearer overview of the NRC's regulatory framework than was provided in the proposed rule discussion, particularly with respect to the delineation between production of radionuclides and radioactive drugs.

Section 651(e) of the EPAct requires the NRC to consider the impact of its regulations on the availability of radioactive drugs to physicians and patients. After consideration, the NRC concluded that its well established regulatory framework for the production, distribution, and use of in vitro test kits, radioactive drugs (which include biologics), and SS&Ds for medical use activities involving byproduct material is also appropriate in large part to similar products containing accelerator-produced radioactive materials. Using the existing regulations could, with minor changes, minimize the impact on the availability of radioactive drugs containing accelerator-produced radionuclides. Therefore, this regulatory framework is applied to the producers, distributors, and medical users of in vitro test kits, radionuclides, radioactive drugs, and SS&Ds containing NARM that are

included in the EPAct's expanded definition of Byproduct material.

Radionuclide Production

The preexisting regulatory framework is directly applicable to the commercial production and distribution of NARM radionuclides. Longer-lived accelerator-produced radionuclides used in medicine may include: thallium-201, cobalt-57, and palladium-103. The shorter half-life PET radionuclides may include: fluorine-18, oxygen-15, and carbon-11. The production of radionuclides by accelerators (including PET radionuclides from cyclotrons), as well as the subsequent possession and use of these radionuclides, will be licensed under existing requirements in 10 CFR part 30. The producer of the accelerator-produced radionuclides (including PET radionuclides) can transfer these radionuclides to manufacturers and other specific licensees under the provisions of 10 CFR 30.41. This includes both commercial and noncommercial distribution of accelerator-produced radionuclides (including PET radionuclides) to specifically licensed universities and research laboratories for basic research but not for use on human beings, which is specifically excluded in the definition of Research and development in 10 CFR 30.4.

These radionuclide production facilities include commercial nuclear pharmacies with PET centers,

i.e.

, facilities with cyclotrons used to produce PET radionuclides. The NRC will review applications and the associated radiation safety programs of these radionuclide production facilities in accordance with the criteria in 10 CFR 30.33 and other existing requirements such as 10 CFR parts 19 and 20. In meeting the general training and experience requirement in 10 CFR 30.33(a)(3), these applicants will need to have individuals with training and experience in the production of PET radionuclides, i.e., the processes from insertion of targets in the accelerator or cyclotron to radiochemical isolation, purification, and testing. Individuals, such as radiochemists, physicists, engineers, and others identified by the applicant with appropriate training and experience, will be recognized as authorized users (AUs) under the manufacturer's, producer's, or pharmacy's 10 CFR part 30 license for the production of accelerator-produced radionuclides (including PET radionuclides) using cyclotrons or other types of accelerators. To ensure the continued availability of accelerator-produced radionuclides used to manufacture or prepare radioactive drugs, it is expected that individuals, who can demonstrate that they performed the radionuclide production activities using an accelerator at a radionuclide production facility under the NRC's waiver (70 FR 51581; August 31, 2005), will be recognized as AUs as long as their duties and responsibilities do not significantly change. The applicant will be required to document that these individuals were responsible for the production of radionuclides using a cyclotron or accelerator when the waiver was in effect.

The NRC is distinguishing between the “production of radionuclides” and “preparation of radioactive drugs.” Production of radionuclides, which would include production of PET radionuclides using a cyclotron (or other accelerator), is regulated under 10 CFR part 30. Preparation of radioactive drugs for medical use from radionuclides, including PET radionuclides, is regulated under 10 CFR 32.72 and 10 CFR part 35. Preparation of radioactive drugs for medical use may occur at locations other than the production facility. In the proposed rule, 10 CFR 32.72 included a provision to authorize commercial nuclear pharmacies that were not registered with FDA or registered with a State as a PET drug production facility to produce PET radionuclides if their radiation safety programs meet the criteria in 10 CFR 30.33. However, the purpose of 10 CFR 32.72 is to address the criteria and requirements for the production and commercial distribution of radioactive drugs for medical use, and not the production of radionuclides. Therefore, the final rule does not include this provision. Based on a review of the requirements in 10 CFR part 30, no revisions to the regulations are needed to license PET radionuclide production under 10 CFR part 30.

10 CFR Part 32 Specific Production and Distribution Requirements.

Byproduct material may be transferred under 10 CFR 30.41 from one specific licensee to another person authorized to receive the material. However, not all transfers can be made under this provision, and certain transfers (or distributions) require that the manufacturer, preparer, or distributor meet specific provisions of 10 CFR part 32. Specifically, a commercial radioactive drug manufacturer or a commercial nuclear pharmacy must obtain a distribution license issued under 10 CFR 32.71 to distribute certain in vitro test kits to generally licensed medical and veterinary clinical laboratories, and a medical distribution (MD) license issued under 10 CFR 32.72 to commercially distribute radioactive drugs to 10 CFR part 35 (and equivalent Agreement State) medical use licensees. The proposed rule included revisions to the qualifications for a licensee to obtain a 10 CFR 32.72 MD license to more accurately describe the FDA registration criteria and to include licensees registered with a State as a PET drug production facility. These provisions are unchanged in the final rule. No changes are necessary for MD licenses issued to medical SS&D manufacturers under 10 CFR 32.74. The MD licenses issued under 10 CFR 32.72 and 10 CFR 32.74 authorize distribution for medical use (10 CFR part 35 and equivalent State) licensees. Under the NRC's licensing practice, most of the 10 CFR part 32 distribution licenses do not authorize the possession and use of byproduct material; rather, separate 10 CFR part 30 licenses are issued for this purpose.

PET radioactive drugs are made with radionuclides that are usually very short lived. In addition to the commercial drug manufacturers and commercial nuclear pharmacies, individual hospitals, educational institutions, and Federal facilities may have cyclotrons used to produce PET radionuclides and may also prepare PET drugs from these PET radionuclides. Although most PET radionuclides are very short lived, certain PET radionuclides with longer half-lives may be transported from the production facility to the user's site. The longer-lived PET radionuclides may also be combined with nonradioactive chemicals and biologics to produce new PET radioactive drugs. Hence, there are production and commercial distributions of some PET radioactive drugs (e.g., fluorine-18 deoxyglucose) to medical users (10 CFR part 35 licensees).

Consortiums and Noncommercial Distribution

The extremely short-lived radionuclides used for medical use have to be made into drugs and administered immediately after production, essentially necessitating that the cyclotron be located in the medical facility or in very close proximity. Some educational institutions, medical use facilities, or Federal facilities may form “consortiums” with adjacent or nearby hospitals to jointly own or share in the operation and maintenance costs of the PET radionuclide production facility. “Consortium” in this context means an association of medical use licensees, and a PET radionuclide production facility, in the same geographical area, that jointly own or share in the operation and maintenance cost of the

PET radionuclide production facility that produces PET radionuclides, for use in producing radioactive drugs within the consortium, for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a Federal facility or a medical facility. These facilities may produce PET radionuclides and radioactive drugs for members of their consortium and make these PET radionuclides and drugs available to these associated facilities through noncommercial distributions. Before this rulemaking, the NRC's regulations did not allow for the noncommercial distribution of radioactive drugs to medical use licensees. The NRC's regulations in 10 CFR 32.72 for the manufacture, preparation, or transfer of radioactive drugs cover only commercial distribution. Medical uses of drugs under 10 CFR 35.100, 35.200, and 35.300 were previously limited to drugs obtained from a 10 CFR 32.72 licensee, or Agreement State equivalent, or prepared by the medical use licensee under specific provisions in 10 CFR part 35. Because the NRC did not allow noncommercial distribution of radioactive drugs, failure to address noncommercial distribution of PET radioactive drugs in the this final rule would impact the availability of these drugs to physicians and patients.

Therefore, the NRC developed a new regulatory process based upon existing practices to minimize impact on the noncommercial distribution of PET radioactive drugs to medical use licensees within such a consortium. In accordance with this process, a part 35 medical use facility that uses its own cyclotron to produce PET radionuclides for use under its own medical use license, would not need to be licensed for medical distribution under 10 CFR 32.72, but it would have to be specifically authorized under 10 CFR part 30 for the production of PET radionuclides.

The definition of

Consortium

incorporates the unique features associated with the noncommercial distribution of PET radioactive drugs. For example, the consortium members must be in the same geographical area because of the short half-lives of PET radionuclides, e.g., 1.8 hours for fluorine-18, 20 minutes for carbon-11, and 2 minutes for oxygen-15. The location of the PET radionuclide production facility is limited to an educational institution or a Federal facility or a medical facility because these are the noncommercial facilities that would have cyclotrons that could produce PET radionuclides.

The NRC will review PET radionuclide production applications and their radiation safety programs in accordance with the criteria in 10 CFR 30.32 and 30.33 and other applicable requirements. In the proposed rule, only the noncommercial transfer of PET radioactive drugs between 10 CFR part 35 medical use licensees was considered. However, the NRC recognized that the entity within the consortium with the PET production operation may not be a medical licensee, but a university or Federal facility. In addition, the radionuclide production facility requires a specific license under 10 CFR part 30. For this reason, the labeling provisions in 10 CFR 35.69, which would only have applied to medical licensees, were relocated from 10 CFR part 35 to 10 CFR part 30.

The new definition of

Consortium

and the provisions for noncommercial distribution are added to 10 CFR 30.4, 30.32, and 30.34 to allow for authorization of the production of PET radioactive drugs for noncommercial transfer to medical use licensees within a consortium. Thus, under these new provisions, a medical use facility, educational institution, or Federal facility with a licensed PET radionuclide production facility within its consortium does not need a medical distribution license under 10 CFR 32.72 if it intends to transfer PET radioactive drugs to members of its consortium. If it intends to commercially distribute PET radioactive drugs or distribute to medical licensees outside of its consortium, then a medical distribution license under 10 CFR 32.72 would be required. In any event, a specific authorization would be required to produce the PET drugs for noncommercial transfer to medical use licensees within its consortium. The requirements for authorization to produce PET drugs for noncommercial transfer to consortium members and the definition of Consortium are being added to 10 CFR 30.4. Specific requirements applicable to this licensed activity are added to 10 CFR 30.34(j). These requirements parallel the requirements for the commercial distribution of PET radioactive drugs, e.g., the licensee is qualified to produce radioactive drugs, the labeling contains consistent information, transport containers are adequately shielded, and radioactivity is accurately determined. Noncommercial distribution of PET radioactive drugs within a consortium may occur among members that are located in the same geographical area even if in different jurisdictions (e.g., Federal facility or other NRC licensees and Agreement State licensees). Thus, these new provisions are being assigned a Compatibility Category B.

Minor revisions were proposed to 10 CFR part 35 to permit medical use facilities to receive PET radioactive drugs by noncommercial transfer and to permit the medical use licensee to use activity values or activity concentration values for these PET radioactive drugs based on the measurements made by a PET radioactive drug producer within its consortium. The final rule also includes these provisions (in 10 CFR 35.65(b)(2) and (c)(3), 35.100(a), 35.200(a), and 35.300(a)), but the provisions are revised to clarify that the PET radioactive drugs have been produced by, and the measurements made by, the licensee authorized under 10 CFR 30.32(j) to produce PET radioactive drugs for noncommercial transfer to members of its consortium.

Authorized Nuclear Pharmacists (ANPs) and Authorized Users (AUs).

No regulatory changes were needed for ANPs to use all byproduct material (i.e., reactor-produced radionuclides, PET radionuclides, and other accelerator-produced radionuclides) to prepare PET radioactive drugs and other radioactive drugs under the practice of pharmacy. Medical use licensees that receive PET radionuclides that are added to “cold kits” may continue to prepare them under the same authorization in 10 CFR 35.100(b), 35.200(b), and 35.300(b) as other unsealed byproduct materials for medical use. However, a minor revision was made to each of these sections to clarify that the ANP and the qualified AU were not authorized under these sections to produce radionuclides.

Further, to ensure the availability of radioactive drugs made from accelerator-produced radionuclides, nuclear pharmacists responsible for the preparation of only PET or other NARM radioactive drugs under the NRC's waiver (70 FR 51581; August 31, 2005) will be “grandfathered” and will not be required to meet the new training and experience requirements as long as their duties and responsibilities under the new license do not significantly change. The “grandfathering” provisions are included in the revised provisions of 10 CFR 35.57 and 10 CFR 32.72(b)(4). The licensee is required by 10 CFR 32.72(b)(5) or 10 CFR 35.14(a) to document that these individuals were responsible for the preparation of only PET or other NARM radioactive drugs when the waiver was in effect.

To ensure a smooth transition and availability of radioactive drugs and sealed sources made from accelerator-produced radionuclides for medical use, those individuals, i.e., physicians, podiatrists, dentists, and radiation safety officers (RSOs), who used only NARM byproduct materials for medical uses under the NRC's waiver (70 FR 51581; August 31, 2005) will also be “grandfathered” in 10 CFR 35.57 as long as their duties and responsibilities do not change significantly. These new grandfathering provisions are limited to those who used only NARM during the waiver, because any prior use of “old” byproduct material would have been subject to the existing requirements for being an AU or ANP or RSO.

These grandfathering provisions were in the proposed rule. However, the final rule does not include revisions to the definition of an

Authorized user

or

Authorized nuclear pharmacist

in 10 CFR 35.2. The NRC concluded that the definitions did not need to be revised because the grandfathering provisions for the RSOs, medical physicists, nuclear pharmacists, physicians, dentists, and podiatrists, who used only accelerator-produced radioactive material, were included in 10 CFR 35.57. Language has been added to 10 CFR 35.57 to clarify that these individuals qualify as AUs and ANPs for purposes of the regulations in part 35. In addition, these individuals could continue to work as AUs, Authorized medical physicists (AMPs), or ANPs under the notification provisions of 10 CFR 35.13 and 10 CFR 35.14.

The radiation safety knowledge needed to safely use NARM for medical uses or for use in the practice of pharmacy is similar to that for other byproduct material. Therefore, individuals who only used NARM radioactive drugs or sealed sources in the practice of medicine or pharmacy will be authorized for use of all similar byproduct material for the same uses. The reverse is also true that individuals already authorized to use byproduct material in 10 CFR part 35 for medical use or for use in the practice of pharmacy are authorized to use NARM. Further, no changes were made to the training and experience criteria in 10 CFR part 35 for any authorized individual.

Actions Taken To Ensure Availability of Accelerator-Produced Radioactive Drugs

In summary, to minimize the regulatory impact on the availability of accelerator-produced radioactive drugs, the NRC is taking the following actions: (1) Applying its established regulatory framework to the commercial distribution of these drugs; (2) expanding the regulations to permit production of PET drugs by medical use licensees, educational institution licensees, and Federal licensees for noncommercial distribution to members of their consortium; (3) permitting medical use licensees to use activity or activity concentration values measured by the PET radioactive drug producer in their consortium when determining dosages; (4) “grandfathering” current medical and pharmacy users of accelerator-produced radioactive drugs; and (5) retaining the existing training and experience criteria in 10 CFR part 35 for authorized individuals.

In addition, as discussed under “Implementation Strategy” in this document, the NRC is revising Parts 30, 32, and 35 to authorize persons that used accelerator-produced radioactive material under the NRC's waiver (70 FR 51581; August 31, 2005) to continue to use these materials after the waiver is terminated, provided that these persons apply for a license or request for a license amendment within the allotted time frames. This regulatory provision allows all persons, including those who manufacture, produce, transfer, receive, acquire, own, possess, or use these materials, to continue with their activities including medical activities until the NRC makes its final licensing decision. This provision also ensures the availability of accelerator-produced radionuclides, radioactive drugs, and sealed sources and devices used for medical uses.

Amendments and Notifications for PET Radionuclide Production and Delivery Lines

The NRC reviewed its regulations in 10 CFR Part 35 to determine if there were radiation safety provisions in its existing regulations that needed revision to incorporate unique radiation safety issues associated with the use of accelerator-produced radionuclides for medical use. The medical use of extremely short-lived radionuclides, e.g., oxygen-15, requires that a PET radioactive drug containing this radionuclide be administered in the imaging and localization medical use area (10 CFR 35.200) immediately after the radionuclide is produced by the cyclotron and processed as a radioactive drug. This necessitates that the medical use area be co-located with the cyclotron or have a PET radioactive drug delivery line from the PET radionuclide production/PET radioactive drug processing area. This introduces the potential for a high radiation area in a medical use area that would otherwise be a low radiation area. This is a unique situation and was not envisioned when the NRC developed the requirements that permitted licensees to make changes in the areas where byproduct material is used only in accordance with 10 CFR 35.100 or 10 CFR 35.200 without submitting a license amendment. As a result, changes have been made to the requirements in revised 10 CFR 35.13, “License amendments,” 10 CFR 35.14, “Notifications,” and 10 CFR 35.15, “Exemptions regarding Type A specific licenses of broad scope.” The final rule provides that an amendment is required for a limited specific medical use licensee in the unique situation described previously if the changes involved movement of the cyclotron or a PET radioactive drug delivery line from the PET radionuclide production/PET radioactive drug processing area. Changes to the typical 10 CFR 35.100 and 10 CFR 35.200 medical use areas are not affected. Section 35.15 is revised to clarify that a licensee possessing a Type A specific license of broad scope would not need to meet the notification requirements in 10 CFR 35.14(b)(5) for any changes to the area of use identified in its application where byproduct material is used in accordance with 10 CFR 35.100 or 10 CFR 35.200. This provision was revised from the proposed rule.

Strontium/Rubidium Generators

Contamination limits for strontium-82/rubidium-82 generators and related requirements consistent with similar provisions of the SSRs are added to 10 CFR part 35. The contamination limits are no more than 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection (0.02 μCi of strontium-82 per mCi of rubidium-82 chloride), or no more than 0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.2 μCi of strontium-85 per mCi of rubidium-82). These limits and requirements to measure the contamination for compliance with these limits are added to 10 CFR 35.204, with corresponding recordkeeping requirements added to 10 CFR 35.2204. A corresponding provision for these tests and associated recordkeeping is also added to 10 CFR 30.34 for nonmedical use licensees, such as commercial nuclear pharmacies, using these generators.

Appendix B to Part 20—Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage

The comparable provisions in Part D of the SSRs do not include any new accelerator-produced radionuclides other than the ones already in 10 CFR part 20, Appendix B. The NRC considered whether some other radionuclide-specific values should be added to 10 CFR part 20, Appendix B. Because nitrogen-13 and oxygen-15 are two of the accelerator-produced radionuclides that are produced for medical uses, the NRC performed a preliminary calculation of values based on dose factors published in National Council on Radiation Protection and Measurements (NCRP) Report No. 123 on Screening Models for Releases of Radionuclides to Atmosphere, Surface Water, and Ground. Certain dose conversion factors were not readily available. Results from these preliminary calculations yielded a derived air concentration (DAC) based on the submersion scenario for both nitrogen-13 and oxygen-15 of about 1.48 × 10

−2

becquerels per milliliter (Bq/ml) (4 × 10

−6

μCi/ml) for occupational exposure and a corresponding effluent concentration of 7.4 × 10

−4

Bq/ml (2 × 10

−8

μCi/ml) for exposure of members of the public. These calculated values are larger than the default values for DAC and effluent concentration by a factor of 40 and 20, respectively, in 10 CFR part 20, Appendix B. Because the approach used in calculating values for nitrogen-13 and oxygen-15 is different from that used for other radionuclides included in 10 CFR part 20, Appendix B, the NRC did not include adding specific values for these radionuclides in the proposed rule. Because certain medical communities had expressed the desire of having specific DACs for these two radionuclides, the Commission specifically requested public comment on the default values, and whether it should include larger specific values for oxygen-15 and nitrogen-13 in the final rule. As a result of comments, these values have been added to 10 CFR part 20, Appendix B, in the final rule. This is discussed further in this document under “Summary and Analysis of Public Comments on the Proposed Rule.”

Emergency Planning

The regulations in 10 CFR 30.32(i)(1) require applications for specific licenses for byproduct material in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in 10 CFR 30.72, “Schedule C—Quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release,” to contain either an evaluation showing that the maximum dose to a person offsite, due to a release of radioactive materials, would not exceed 0.01 sievert (Sv) (1 rem) effective dose equivalent or 0.05 Sv (5 rems) to the thyroid, or an emergency plan for responding to a release of radioactive material. Schedule C also contains a release fraction for each radionuclide against which aspects of the evaluation submitted in place of an emergency plan must be compared in accordance with 10 CFR 30.32(i)(2).

Although Part P, “Contingency Planning for Response to Radioactive Material Emergencies,” of the SSRs addresses an emergency plan, a value for radium-226 is not specifically listed. The NRC staff therefore considered NUREG-1140, “A Regulatory Analysis on Emergency Preparedness for Fuel Cycle and Other Radioactive Material Licensees,” dated August 1991. NUREG-1140 was used as the technical basis in a past rulemaking effort related to quantities of radioactive materials requiring an emergency plan. NUREG-1140 provided the basis for 10 CFR 30.72 Schedule C values. Schedule C also contains a default value for alpha emitters of 74 gigabecquerels (GBq) (2 curies (Ci)) (with release fraction 0.001), which would apply to discrete sources of radium-226 absent a specific value being added to the table. However, the quantity value for radium-226 in NUREG-1140 is 3.7 terabecquerels (TBq) (100 Ci) along with a release fraction value of 0.001. This final rule adds radium-226 with the quantity 3.7 TBq (100 Ci) and release value 0.001 to 10 CFR 30.72 Schedule C, which is consistent with the technical basis for the original emergency planning requirements. It is expected that few, if any, licensees, or applicants for a license, would have 3.7 TBq (100 Ci) of discrete sources of radium-226. Because the “rule of ratios” applies (See Footnote 1 to 10 CFR 30.72), licenses authorizing other byproduct material, in quantities approaching values that would require emergency planning, which are being amended to add significant quantities of discrete sources of radium-226, could potentially result in authorizing total quantities of byproduct material that would meet the criteria for emergency plan requirements. It is not expected that accelerator-produced radioactive materials are used in significant enough quantities to affect the applicability of emergency plan requirements.

Low-Level Radioactive Waste and Decommissioning

Low-Level Radioactive Waste

Section 651(e)(3) of the EPAct mandates that the newly added byproduct material is not considered to be low-level radioactive waste for the purposes of the Low-Level Radioactive Waste Policy Amendments Act (42 U.S.C. 2021b) (LLRWPAA). The intent of this provision is that the newly added byproduct material is not to be impacted by the compact process of the LLRWPAA. This provision does not have an impact on the NRC's policy and requires only a minor change to the regulations to ensure that the term “low-level radioactive waste,” when used in the NRC's requirements, does not include the newly added byproduct material.

Although the newly added byproduct material is not considered low-level radioactive waste, it does pose a similar hazard, and it does need to be disposed of appropriately. Section 651(e)(3) of the EPAct requires that the newly added byproduct material must be disposed of in a facility that: (1) Is adequate to protect public health and safety; and (2) is licensed by the Commission or by an Agreement State. Even though it is not low-level radioactive waste, this provision clarifies that the newly added byproduct material is to be disposed of in a facility licensed by the NRC under 10 CFR part 61 or the Agreement State requirements, which are compatible to 10 CFR part 61. This provision also allows for the disposal of the newly added byproduct material in a facility licensed by the NRC under other parts of the NRC's regulations, such as facilities licensed under 10 CFR part 40, Appendix A.

To ensure that disposal facilities licensed under 10 CFR part 61 continue to be adequate to protect public health and safety, the NRC must consider the specific health and safety issues associated with disposal of discrete sources of radium. Rather than making any changes to 10 CFR part 61 at this time, the NRC will evaluate any specific disposals of discrete sources of radium at an NRC-licensed disposal facility under 10 CFR 61.58, “Alternative requirements for waste classification and characteristics.” The NRC has not identified any other radionuclides being added to the definition of Byproduct material that require any specific evaluations to ensure the proper disposal of waste in accordance with 10 CFR part 61.

Notwithstanding the previously mentioned provisions for the NRC or Agreement State licensing of the disposal facility for the newly added byproduct material, Section 651(e)(3) of the EPAct does not affect the authority of any entity to dispose of the newly added byproduct material at a disposal facility in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act. This means that Federal and State solid or hazardous waste laws can continue to be used as an authority to permit disposal of this newly added byproduct material. Disposal solutions already in place to allow disposal of the newly added byproduct material are unaffected by the EPAct. To implement this provision of the EPAct, the NRC is changing its regulations in 10 CFR Part 20 to redefine Waste to allow disposal of the newly added byproduct material in the NRC-regulated disposal facilities or in a disposal facility permitted under Federal or State solid or hazardous waste laws.

Appendix G of 10 CFR Part 20, the uniform manifesting requirements for low-level radioactive waste, includes numerous requirements containing the words “low-level radioactive waste” and “waste.” This is potentially confusing because the newly added byproduct material is not low-level radioactive waste in accordance with the provisions of the EPAct. However, no changes have been made to Appendix G to 10 CFR Part 20. The text changes made to the 10 CFR Part 20 regulations to clarify that the newly added byproduct materials are not “low-level radioactive waste” make it clear that the Appendix G to 10 CFR Part 20 requirements must be met if any of the newly added byproduct material waste is to be disposed of at a facility licensed under 10 CFR Part 61 or an equivalent Agreement State rule.

Decommissioning Issues

The inclusion of accelerator-produced radioactive material that is used for a commercial, medical, or research activity, in the definition of

Byproduct material

, requires the NRC to ensure that decommissioning funding is adequate at accelerator facilities to adequately decontaminate and decommission their facilities for license termination. Radioactive materials produced in accelerator facilities, that are produced, extracted or converted after extraction for use for commercial, medical, or research purposes and that are no longer residing in the accelerator, are not a concern for decommissioning. However, materials intentionally or incidentally made radioactive as a result of the production of the radioactive materials for use for commercial, medical, or research purposes must be managed safely. Any radioactive material residing in the accelerator or within the facility that houses the accelerator must be adequately considered for safe operation, and managed appropriately at the time of decommissioning of the accelerator-produced radionuclide production facility, including the accelerator, and the NRC must ensure that adequate financial assurances are put in place to address the costs of decommissioning when the radionuclide production operation ceases, and the accelerator is shutdown, and the license is terminated. As with all decontamination and decommissioning situations, short-lived radionuclides are expected to decay to safe levels before license termination. Therefore, only radionuclides with a half-life of more than 120 days, that are present in sufficient quantities specified in 10 CFR 30.35, need to be addressed for the purposes of establishing adequate financial assurances for decommissioning.

Similarly, the addition of discrete sources of radium-226 in the definition of

Byproduct material

requires the NRC to ensure that decommissioning funding is adequate for holders of specific licenses for possession of discrete sources of radium-226. Radium-226 is already included in Appendix B of 10 CFR Part 30 to determine the required level of financial assurance for holders of specific licenses in accordance with the requirements of 10 CFR 30.35. Therefore, applicants for specific licenses to possess discrete sources of radium-226 will need to assure that adequate financial assurances are provided for the types of sources and the total amount of radium-226 contained in the sources they will possess. Holders of general licenses for possession of discrete sources of radium-226 do not need financial assurance for decommissioning. However, in accordance with the approach for general and specific licensing of discrete sources of radium-226 being undertaken by the NRC in this final rule, a general licensee may become subject to specific licensing if the accumulated number of discrete sources of radium-226 exceeds the allowable quantities of a general license. If a general licensee becomes subject to specific licensing, the licensee would be required to acquire the financial assurances required under 10 CFR 30.35.

The NRC believes that the financial assurance requirements included in 10 CFR 30.35 are adequate to ensure that any person who will receive a specific license authorizing possession and use of byproduct material will be required to have adequate financial assurance in place for decommissioning the facility. Therefore, the NRC is not changing the regulations governing financial assurance for decommissioning.

The NRC is cognizant of the potential existence of facilities and sites which may be, or have the potential to become, contaminated with significant amounts of radium-226 from past practices or operations. Additionally, the potential exists for significant quantities of discrete sources of radium-226 to have been previously disposed of by both licensees and nonlicensees at their facilities. The existing requirements for licensing and decommissioning in 10 CFR Part 30 are sufficient to address these situations for any facilities that will apply for a specific license or amendment to authorize possession of discrete sources of radium-226 for their current operations. The applications to the NRC, in these cases, would include a facility-specific decommissioning plan that addresses the current contamination and any previous onsite disposals.

There are no similar assurances for any facility that is currently contaminated from discrete sources of radium-226 but is not licensed. With the inclusion of discrete sources of radium-226 in the definition of

Byproduct material

, the NRC acquires the regulatory authority to address these situations where a specific license has not been issued (or where a potential licensee cannot be identified). At 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. Therefore, the NRC will address these situations on a case-by-case basis as they are identified following the effective date of this final rule.

D. License Application and Annual Fees

The NRC is required to recover approximately 90 percent of its budget authority each year under the Omnibus Budget Reconciliation Act of 1990 (OBRA-90), as amended. Therefore, the NRC charges licensing, inspection, and annual fees to its applicants and licensees. Each type of fee includes agency and program overhead. The NRC revises these fees each year in light of its current fiscal year budget and other factors, including changes in the regulatory efforts associated with the different classes of licensees.

Persons applying for a license with the NRC, or requesting an amendment to their current licenses that may result in the addition of a new fee category, are required to pay a license application fee under 10 CFR Part 170, unless exempt under the fee exemption provisions of 10 CFR 170.11. The application fees for materials users are “flat” fees that are calculated by multiplying the average professional staff hours needed to process the application by the professional staff-hour rate in 10 CFR 170.20 ($258 in the FY 2007 final fee rule). An application fee must generally be paid for each applicable fee category.

Additionally, all persons who hold licenses issued by the NRC are subject to annual fees under 10 CFR Part 171, unless exempt under the provisions of 10 CFR 171.11. The 10 CFR Part 171 fee categories, and the associated fees for materials users, are provided in 10 CFR 171.16, and must generally be paid for each applicable fee category. A licensee may request consideration as a small entity for the annual fees which may result in a reduced fee, as described in 10 CFR 171.16.

The annual fees for the materials users fee class are calculated based on the NRC's budgeted resources allocated to regulating these types of licensees, less any receipts received from this fee class for 10 CFR Part 170 activities. The net dollar value of budgeted resources for this fee class is allocated to all materials user fee categories (subclasses) based on the average application and inspection costs associated with each category. This approach provides a proxy for allocating the generic and other regulatory resources to the diverse categories of licensees based on how much it costs the NRC to regulate each fee category. The fee calculation also considers the inspection frequency (priority based), which is indicative of the safety risk and resulting regulatory costs associated with these categories of licenses.

The license application fees schedule is in 10 CFR 170.31. The annual fees schedule is in 10 CFR 171.16. The fee amounts included in the proposed rule were based on the FY 2005 fees. The fee amounts noted in the final rule are based on the final FY 2007 fees. The final 2007 fee rule was published June 6, 2007 (72 FR 31402).

The NRC believes that the majority of the NRC's licensees affected by this final rulemaking will be using radioactive material in a manner similar to their existing authorizations, and their existing fee categories should not change as a result of this rule. However, some licensees may need to amend their licenses to add one or more new fee categories, if applicable, for new uses and radioactive material now considered byproduct material, i.e., accelerator-produced radioactive material or discrete sources of radium-226.

The NRC is establishing three new fee categories for activities that were not previously covered by its regulations. The new fee categories apply to certain items previously manufactured and self-luminous products containing radium-226 and to the production of accelerator-produced radioactive material. In determining the fees for these new categories, the NRC evaluated existing fee categories that the NRC believes require a similar level of regulatory effort as these newly regulated activities for actions such as licensing, inspection, and event response.

Most individuals and other entities collecting items containing radium-226 are expected to be eligible to be exempt from license under 10 CFR 30.15 or for a general license under the new 10 CFR 31.12, “General license for certain items and other self-luminous products containing radium-226.” Therefore, they would be subject to the requirements of 10 CFR 30.15 or 10 CFR 31.12 (e.g. proper disposal of the radioactive material). However, if a person collects more than the number of items or limits specified in these sections, that person will be required to obtain a specific license and be subject to the regulations regarding license application and annual fees. The NRC is establishing a new fee category, 3.R., with a two-tiered fee level, for those persons requiring a specific license for items containing radium-226. The distinction between the two fee levels is based on the number of items or limits specified in 10 CFR 31.12(a)(4) or (5) and the estimate of the level of regulatory effort between the two levels. Licensees who currently possess radium sources in amounts that exceed the general license provisions of 10 CFR 31.12 would be required to add the sources to their specific license. This would normally subject the licensee to the fees in this new fee category. However, if the radium-226 sources are used for operational purposes that are covered under another fee category, the licensee will not be subject to the fees in this new fee category. This exception will not apply if the radium sources are possessed for storage only.

The first new fee Category 3.R.1. is for persons possessing quantities greater than the number of items or limits in 10 CFR 31.12(a)(4) or (5), but less than or equal to 10 times these quantities. Because the estimated level of regulatory effort is comparable to the level of effort for Category 8, Civil defense, the license application and annual fees for 3.R.1. will be $590 and $2,100, respectively. The second new fee Category 3.R.2. is for persons possessing quantities greater than 10 times the number of items or limits in 10 CFR 31.12(a)(4) or (5). The license application and annual fees for this new category, 3.R.2., will be $1,400 and $2,700, respectively, comparable to the fees for Category 3.P., “All other specific byproduct material licenses, except those in Categories 4A through 9D.”

Persons who wish to disassemble, repair, or assemble products containing radium-226 will be required to obtain a specific license and will be subject to the applicable license application and annual fees. The NRC is including this use in fee Category 3.B., “Other licenses for possession and use of byproduct material issued under 10 CFR Part 30 of this chapter for processing or manufacturing of items containing byproduct material for commercial distribution.” The license application fee for this category will be $4,600, and the annual fee will be $8,400.

The NRC is adding a new fee Category 3.S. for the production of accelerator-produced radioactive materials. The NRC is adding this new fee category because these production activities need to be distinguished from those activities that only involve the use of already-prepared radionuclides. The regulatory effort for the new fee Category 3.S. is estimated to be similar to that for fee Category 3.C. The license application and annual fees for this new category will be $8,000 for the application fee and $10,900 for the annual fee. The annual fee for category 3.S. in this final rule is slightly less than that for category 3.C. because the category 3.S. fee does not include a portion of the low-level waste (LLW) surcharge, while the category 3.C. fee does. This is because the licensees in fee category 3.C. directly benefit from the NRC's LLW activities, but the licensees in fee category 3.S. do not. Fee amounts included in this final rule are different from those included in the proposed rule because they are based on the FY 2007 Fee Schedules instead of the FY 2005 Fee Schedules.

E. Implementation Strategy

Specific provisions are included in this rule, and several actions are planned in conjunction with, or following, the issuance of this final rule covering the newly added byproduct material, including:

(1) Issuance and publication of a Transition Plan for the orderly

transition of regulatory authority for the newly added byproduct material;

(2) Termination of the waiver issued by the NRC (70 FR 51581; August 31, 2005) for the States and users of the newly added byproduct material; and

(3) Inclusion of specific provisions allowing users of the newly added byproduct material to continue with their activities for a period of time while coming into compliance with the newly issued regulations.

Transition Plan

Section 651(e) of the EPAct requires the NRC, in issuing new regulations for the newly added byproduct material, to prepare and publish a Transition Plan for the orderly transition of regulatory authority over the newly added byproduct material for Agreement and non-Agreement States. The EPAct requires that the Transition Plan describe the conditions under which a State (including U.S. Territories and the District of Columbia) may exercise authority over the newly added byproduct material, and include a statement of the Commission, that any agreement between the Commission and a State under Section 274b. of the AEA, covering byproduct material, and entered into before the date of publication of the Transition Plan, be considered to include the newly added byproduct material. The statement of the Commission is subject to a certification provided by the Governor of the State to the Commission on the date of publication of the Transition Plan that: (1) the State has a program for licensing the newly covered byproduct material that is adequate to protect the public health and safety, as determined by the Commission; and (2) the State intends to continue to implement the regulatory responsibility of the State with respect to the byproduct material. The NRC also will include in the Transition Plan the process it will use to terminate the waiver issued by the NRC on August 31, 2005, and for the transition of regulatory authority following expiration or earlier termination of the waiver.

Termination of Waiver

The waiver issued by the NRC (70 FR 51581; August 31, 2005) is effective through August 7, 2009 (except terminated August 7, 2006, for the import and export of materials covered by the waiver), unless terminated earlier by the Commission. The waiver applies to Agreement and non-Agreement State regulatory programs and users of the newly added byproduct material, and allows persons owning, using, and otherwise engaging in activities involving the material to continue with their activities and the States to continue to regulate this material during the applicable waiver period. All persons in States (including U.S. Territories and the District of Columbia) that do not have an agreement with the Commission under Section 274b. of the AEA that covers the newly added byproduct material on or before August 7, 2009, will automatically be subject to the NRC regulatory authority for the material on August 8, 2009. The waiver also may be terminated earlier than August 7, 2009, if the Commission determines that an earlier termination is warranted.

For a new or existing Agreement State that intends to implement the regulatory program of the State with respect to the newly added byproduct material, Section 651(e) of the EPAct requires that the waiver be terminated for the State when the Commission determines that the State has entered into an agreement with the Commission, under Section 274b. of the AEA, that the State program covers the newly added byproduct material, and that the State program for licensing the newly added byproduct material is adequate to protect the public health and safety. The Commission determination and termination of the waiver will be noticed in the

Federal Register

(Notification of Waiver Termination). Users of the newly added byproduct material currently licensed, or registered, by an Agreement State that continues to implement its regulatory program, with respect to the newly added byproduct material, will continue to be subject to the Agreement State regulatory authority.

With regard to the States that do not have an existing agreement with the Commission under Section 274b. of the AEA (non-Agreement States), the waiver period provides additional time for those States that desire to establish such an agreement for the newly added byproduct materials to develop a program. To establish this agreement with the Commission, the Governor of the current non-Agreement State will need to request an agreement with the Commission. The process of establishing these agreements can take 3 or more years to complete. Options will be considered, on a case-by-case basis, to limit the impact of the transition of authority on affected users of the new byproduct material in the State.

Additional details on the process that the NRC will use to terminate the waiver for Agreement and non-Agreement States and users in these States will be provided in the Commission's Transition Plan, as required by Section 651(e) of the EPAct. The NRC plans to publish the Transition Plan following publication of this final rule and before the effective date of this final rule.

Notification of Waiver Termination

The Commission is terminating the waiver for Government agencies and Federally recognized Indian Tribes on the effective date of this final rule because there is currently limited regulatory oversight for the newly added byproduct material at these facilities. Waiver termination is necessary to require Government agencies and Federally recognized Indian Tribes to comply with the new requirements and for the NRC to ensure protection of public health and safety for the newly added byproduct material.

The Commission has also determined that an earlier termination is warranted and is therefore terminating the waiver for persons owning, using, and otherwise engaging in activities involving the newly added byproduct material in the following States on the effective date of this final rule: Delaware, Indiana, Wyoming, and Montana, as well as the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. The effective date of this final rule is 60 days after the date of publication in the

Federal Register

. Waiver termination is necessary to require persons owning, using, and otherwise engaging in activities involving the newly added byproduct material in these States, U.S. Territories, and the District of Columbia to comply with the new requirements and for the NRC to ensure protection of public health and safety for the newly added byproduct material.

Implementation Period

Although Government agencies, Federally recognized Indian Tribes, and certain persons owning, using, and otherwise engaging in activities involving the newly added byproduct material in the States of Delaware, Indiana, Wyoming, and Montana, and the District of Columbia, Puerto Rico, and the U.S. Virgin Islands are already being regulated by the NRC for the AEA 11e.(1) and 11e.(2) byproduct material, the NRC is allowing a transitional period for them to submit a license amendment or a new license application for the newly added byproduct material. This final rule allows an additional 6-month period from the effective date of the final rule to apply for a license amendment; and an additional 12-month period from the effective date of the final rule to apply for a new license.

In addition, the rule contains specific provisions that gives Governmental agencies, Federally recognized Indian Tribes, and persons owning, using, and otherwise engaging in activities involving the newly added byproduct material, in the States of Delaware, Indiana, Wyoming, and Montana, and the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, the authority to continue to use the newly added byproduct material during the period following the waiver termination until the date of the NRC's final licensing determination, provided that either a license amendment or a license application is submitted within the specified time frame and while complying with all other aspects of the regulations (e.g., event reporting, personnel dosimetry) upon the effective date of this final rule.

For persons owning, using, and otherwise engaging in activities involving the newly added byproduct material, compliance with the rule will be required depending on the date of waiver termination. For certain States and persons, the NRC plans to terminate the waiver earlier than the final date of the waiver, i.e., August 7, 2009. A decision for early termination will depend on a number of factors, including the status of an Agreement State Governor's certification of adequate program for the newly added byproduct material, status of a non-Agreement State's application to become an Agreement State, and activities or areas under exclusive NRC jurisdiction. Upon waiver termination, all persons that possess the new byproduct materials must be in compliance with NRC regulations. It is noted that being in compliance with the NRC regulations includes, for example, meeting the reporting and recordkeeping requirements for the new byproduct material once the waiver is terminated. In addition, such persons will 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. It is noted that authorization statements for certain licenses are inclusive of byproduct materials and their uses so that an amendment may not be needed to specifically add NARM to the license.

During the time between the termination of the waiver and the user's application for an NRC license or license amendment, users in Government agencies, Federally recognized Indian Tribes, and non-Agreement States will be under the NRC's jurisdiction for enforcement purposes. The NRC will handle enforcement cases involving the use of the newly regulated materials on a case-by-case basis. However, should the number of cases involving these materials be larger than anticipated, the staff will prepare additional enforcement guidance to ensure consistency in handling such issues.

III. Summary and Analysis of Public Comments on the Proposed Rule

The proposed rule on Requirements for Expanded Definition of Byproduct Material was published on July 28, 2006 (71 FR 42952). The comment period ended on September 11, 2006. The NRC received 39 comment letters on the proposed rule. Comment letters were submitted from the States, other Federal agencies, professional organizations, universities, medical communities, industries, and individuals. On August 22, 2006, the NRC held a public meeting in Las Vegas, Nevada, on the proposed rule during the comment period. Copies of the public comments and the public meeting transcripts are available for review in the NRC Public Document Room, 11555 Rockville Pike, Rockville, Maryland.

In addition to requesting public comments on the proposed rule, the NRC specifically requested additional information or comments on 15 specific items outlined in Section II.G. of the proposed rule. A synopsis of the items and type of comments received are as follows:

Item 1—Technical Information to Support Exemption of Old Radium-226 Sources. One commenter provided information on potential pressure build-up within radium sources that could lead to the release of radium into the environment. Another commenter provided a reference to an FDA document. There were comments on the availability of information on radium-226 items and on exemption of antiquities. The NRC appreciates the information. A discussion of the comments on exemption of antiquities and associated response is included later in this document under “Comments Related to Radium-226.”

Item 2—Extent of Use of Accelerators. No comments were received regarding the extent of accelerators that are used to intentionally produce radioactive material and also used to generate particle beams for basic science research. One commenter indicated that the commenter's organization does not operate any particle accelerators for the purpose of producing radioactive materials and producing particle beams for other uses. Another commenter informed the NRC that it will be building a new accelerator facility where radionuclides will be produced.

Item 3—Information on Decommissioning of Accelerator Facilities. Several comments were received regarding information on decommissioning of accelerator facilities, including accelerator components and facility building materials that may become activated. A detailed discussion of the comments and response is included later in this document under “Comments on Waste and Decommissioning.”

Item 4—Inclusion of Specific ALI and DAC Values. In response to the NRC's question on whether to develop specific ALI and DAC values for oxygen-15 and nitrogen-13 for inclusion in 10 CFR Part 20, Appendix B, several commenters provided specific DAC values. A discussion of the values and the methodology used can be found later in this document under “Comments on Other General Requirements.”

Item 5—Exemption of Radium-226 Timepiece Repairs. In regard to the appropriateness of the proposed exemptions to allow repairs of 10 radium-226 timepieces per year, one commenter suggested increasing the proposed limit of 10 per year to 18. The commenter did not provide specific data concerning how active the repair of radium-226 timepieces may be or the safety significance of the proposed exemption. However, there were several comments related to radium-226 exemptions. Detailed discussion of these comments and the associated responses is included later in this document under “Comments Related to Radium-226.”

Item 6—Health and Safety Information of Radium-226 Sources. The NRC requested information on the health and safety impact from activities involving radium-226 sources, in particular, information to support a technical basis for an exemption as an alternative to the proposed general licensing approach. Several commenters indicated that they believed that an exemption would be preferable to a general license for items containing radium-226, but no specific health and safety impact information was provided. Most commenters agreed that more information about risk is needed to make a final decision. Discussion of comments associated with this issue is included later in this document under “Comments Related to Radium-226.”

Item 7—Existing and Proposed Fee Categories. The NRC requested information on whether the majority of

licensees would remain in the existing fee categories and whether new NARM licensees would fall under the current fee categories or the new proposed fee categories. No specific information on this issue was received from the commenters. However, several commenters indicated that they believed that there is no need to establish a new fee category for the production of accelerator-produced radioactive material. All of the comments related to fees are discussed later in this document under “Comments on Licensing Fees and Fee Categories”.

Item 8—Licensing Boundaries for Radium-226 Private Collectors. No information was received on whether private collectors of items or products containing radium-226 would remain within the boundaries of the proposed general license or be required to obtain a specific license and be charged with the associated licensing fees. One commenter recommended that an “exception” be extended to certain organizations. A discussion of radium-226 exemptions is included in subsection “Comments Related to Radium-226,” and a discussion of fees is included later in this document under “Comments on Licensing Fees and Fee Categories”.

Item 9—Two-Tiered Fees for Radium-226. No information was received regarding the two-tiered license fees proposed for possession of different quantities of radium-226 items. Comments received on the proposed fee categories and amounts are discussed later in this document under “Comments on Licensing Fees and Fee Categories”.

Item 10—Effective Date and Implementation Periods. Several comments were received on the proposed effective date and implementation periods of the rule. A discussion is included later in this document under “Comments on Waiver Termination and Transitioning.”

Item 11—Compatibility Category Designations. All comments related to the compatibility category designations are discussed later in this document under “Comments Related to Agreement States and Other Government Agencies”.

Item 12—Environmental Assessment. Comments received on the draft Environmental Assessment were considered in the final Environmental Assessment and Finding of No Significant Impact.

Item 13—Information Collections. No comments were received on the information collections aspects of the rule.

Item 14—Regulatory Analysis. No comments were received on the draft Regulatory Analysis.

Item 15—Impact to Small Business. No comments were received on the impacts of the rule on small businesses.

General information and editorial suggestions received on the proposed rule are appreciated but do not need to be discussed in this final rulemaking. Comments associated with nuclear reactors and the high-level waste repository are outside the scope of this rulemaking; therefore, they will not be addressed in this section. All other comments have been grouped into broad categories, and a detailed discussion of the comments and the NRC's responses are as follows:

Comments Related to Agreement States and Other Government Agencies

Agreement State Compatibility Designations

Comment:

The comments received on “compatibility” are primarily centered around one main concern: Implementation of the requirements for the Compatibility Category of Health and Safety (H&S) for several definitions. The basic concern expressed by these commenters was that the States should not be required to amend their definitions in their State statutes and regulations. In particular, some commenters were concerned about the designation of H&S for the definition of

Byproduct material.

These commenters indicated that they would support an H&S designation if the Statements of Consideration to the final rule provided that the NRC's initial determination of the adequacy of definitions would rely on a Governor's certification that the State's program was “adequate,” and that if the Governor's certification was accepted, no changes to the State's definitions would be required. As an alternative, some commenters suggested that the Statements of Consideration recognize that the States could use alternative language in their definitions including the use of the more generic term of “radioactive material,” rather than revise the definitions to conform with the new definitions. In the absence of implementing those suggestions, these commenters recommended that the Compatibility Category designation for definitions be changed from H&S to D.

These commenters generally indicated that if those suggestions could not be implemented, they would recommend that the NRC designate the definitions it was changing as Compatibility D.

NRC Response:

The NRC does not agree with the commenters' assertion that the designation for the definition of

Byproduct material

should be changed from H&S. The NRC also does not agree that the Governor's certification of the adequacy of an Agreement State's program should relate to the need for the State to revise its regulations. However, the States may continue to use the existing definition including

Radioactive material

in State statutes and regulations, although there may be limited areas where a State may need to revise its regulations to include material now under the jurisdiction of the NRC (e.g., exempt distribution for certain materials).

The NRC applied the criteria in Management Directive (MD) 5.9, “Adequacy and Compatibility of Agreement State Programs,” in evaluating the compatibility category of the definitions, and determined that a category of H&S is appropriate for the definition of

Byproduct material.

MD 5.9 provides that an H&S designation is appropriate for elements that are not required for compatibility but have been identified as having a particular health and safety role in the regulation of agreement material within the State. In accordance with this designation, the State should adopt program elements, based on those of the NRC, that embody the essential objectives of the NRC program elements because of particular health and safety considerations. A category of H&S is appropriate for the definition of

Byproduct material

because the absence of the essential objectives of the program element from an Agreement State program could create a situation that could directly result in exposure to an individual in excess of basic radiation protection standards.

MD 5.9 provides that the NRC program elements in Compatibility Category D are those that do not meet the criteria of Compatibility Categories A, B, or C, and thus, do not need to be adopted by the Agreement States for purposes of compatibility. The NRC has determined that a Compatibility D designation is not appropriate for the definition of

Byproduct material

because if the definition of

Byproduct material

or another term which encompasses all of the byproduct material regulated by the State were not somewhere within the State program (i.e., in statute or in regulations), it is possible that some byproduct material could escape regulatory oversight with a result of exposure to an individual in excess of the 10 CFR Part 20 limits. The State regulatory program must include Sections 11e.(3) and 11e.(4) byproduct

material in its regulatory program if the Agreement includes this material, thus, an H&S designation (an assessment of adequacy) is appropriate.

In implementing the Commission's policy on Agreement States, a designation of H&S for the definition of

Byproduct material

will require NRC staff to continue to assure that the essential objectives (i.e. Sections 11e.(3) and (4) byproduct materials are addressed in the regulatory program) are met. The NRC staff notes that under a designation of D, this assurance would not be obtained because program elements designated D are not a required part of an Agreement State program (they could be dropped from or not included in the Agreement State program, and the program could still be found adequate and compatible).

Comment:

With regard to the definitions in 10 CFR 35.2 of

Authorized nuclear pharmacist,

Authorized user,

and

Positron Emission Tomography (PET),

one commenter recommended that any Agreement State that has rule language essentially the same as the current CRCPD's SSRs should be considered to have compatible rules and should not have to revise those rules regardless of the level of compatibility assigned by the NRC. The commenter further recommended that the NRC might include this recognition in the Statements of Consideration.

NRC Response:

The NRC has determined that it is not necessary to change the current definitions for an

Authorized user

or

Authorized nuclear pharmacist.

This rule does not change the existing definitions or impact the existing compatibility designation for these definitions. The definition of

Positron Emission Tomography

is not in the SSRs, and it is identified in the final rule as having a designation of “H&S,” which assures that the State's regulatory programs adequately address the essential objectives of the NRC program elements when using the term

Positron Emission Tomography.

Comment:

For each of the sections with a Compatibility B Category, it is not clear that the NRC accepts the language of the States that is essentially identical to the SSRs.

NRC Response:

For the definitions and sections assigned a Compatibility B designation, the NRC cannot automatically accept the States' language; the States' regulations must be reviewed. Agreement State regulations will be reviewed according to Office of Federal and State Materials and Environmental Management Programs (FSME) Procedure 201 (SA-201) and should be submitted within 3 years of publication, in accordance with the NRC's 1997 Policy Statement on Adequacy and Compatibility of Agreement State Programs (62 FR 46517; September 3, 1997). The NRC notes that portions of the SSRs may be outdated and do not reflect recent amendments (e.g., definitions of

Authorized user

and

Authorized nuclear pharmacist

) and so cannot be used.

Comment:

Referring to 10 CFR 32.72, a commenter recommends that the NRC specifically recognize that an Agreement State will not be required to amend its comparable regulation, as long as that comparable regulation provides for the same control of the manufacture and initial distribution of radium-226 sources under a general license as was provided in the proposed regulation.

NRC Response:

The NRC does not agree with the comment. Section 32.72 in 10 CFR Part 30 authorizes specific licensees to manufacture, prepare, and distribute radioactive drugs to medical use licensees. This provision does not include generally licensed material. Further, the NRC is unaware of any radioactive drugs containing radium-226. Agreement States have 3 years to adopt regulatory requirements compatible with 10 CFR 32.72 revisions.

For a specific license to allow the manufacture or initial transfer of calibration or reference sources containing radium-226, under 10 CFR 32.57, for distribution to persons generally licensed, the NRC has included provisions in 10 CFR 31.8 to recognize specific licenses issued for these sources by a State with comparable regulations.

Comment:

A commenter stated that the NRC's deliberate use of Compatibility B and H&S categories sets the tone that its considerations are preeminent. Another commenter stated that the language of the EPAct indicates that the burden should be on the NRC to bring its regulations into conformance with the Agreement State regulations. The commenter also stated that whether or not the NRC is making an effort to obey the EPAct language to cooperate with the States or use model State standards will depend on whether the NRC accepts the Agreement States' regulations. The commenter believes that the Agreement State regulations do not need to be changed to be exactly like the NRC's.

NRC Response:

In accordance with AEA Section 274b, for an agreement between the NRC and a State, a State program must be adequate to protect public health and safety and be compatible with the NRC. The EPAct gives the NRC jurisdiction over NARM byproduct material, and does not mandate that the NRC bri

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