Accelerator-Produced and NARM Byproduct Material

The Energy Policy Act of 2005 and the NRC's 2007 expanded-definition rule folded accelerator-produced radioactive material and certain naturally occurring material—together, NARM—into the Atomic Energy Act's definition of byproduct material, so the F-18, Ga-68, and other cyclotron-made isotopes a PET program depends on are now federal byproduct material. That single change determined who licenses the material, which radiation-protection rules apply, and what a medical facility's radiation safety program must document. ^{1, 2, 3}

For most of the nuclear era, "byproduct material" meant material made radioactive in a reactor. The short-lived positron emitters that power modern PET—and the radium and other naturally occurring sources scattered through older healthcare facilities—sat outside that federal definition and were regulated unevenly, state by state. A facility could hold an NRC or Agreement State license for reactor-produced isotopes while its cyclotron-made F-18 answered to an entirely different authority. The 2007 rule closed that gap. ^{3, 5}

This guide explains what accelerator-produced and NARM material are, the physics of how these isotopes are made and why their short half-lives do not exempt them, the statutory and regulatory change that brought them under federal jurisdiction, and the practical licensing and radiation-safety consequences for medical facilities. DRPS supports facilities with radioactive material license support and radiation safety officer consulting across Florida, Maryland, Virginia, Washington DC, California, Nevada, Pennsylvania, New York, New Jersey, and Delaware.

Introduction

The Atomic Energy Act (AEA) sorts regulated radioactive material into categories: source material (uranium and thorium), special nuclear material (enriched uranium and plutonium), and byproduct material. For decades, byproduct material meant, in essence, material made radioactive incident to producing or using special nuclear material—reactor-produced radionuclides such as Mo-99/Tc-99m, I-131, and Lu-177. ⁴

Material that was radioactive but did not fit those categories—radium-226 in legacy sources, and radionuclides produced in accelerators—was lumped together informally as NARM: naturally occurring and accelerator-produced radioactive material. NARM was not federal byproduct material, so the NRC had no jurisdiction over it, and the states regulated it under their own rules with varying rigor. ⁵ That meant a PET isotope like F-18 could be regulated very differently depending on the state. The Energy Policy Act of 2005 set out to fix the inconsistency. ^{1, 3}

Topic Explanation

The AEA categories and where NARM sat

Before 2005, the AEA's byproduct-material definition did not reach accelerator-produced radionuclides or discrete radium sources. A facility's reactor-produced isotopes were federal byproduct material (NRC or Agreement State jurisdiction), while its cyclotron-produced isotopes were NARM (state jurisdiction only). Two regulatory systems, one radiopharmacy. ⁵

What the expanded definition added

Section 651(e) of the Energy Policy Act of 2005—titled "Treatment of Accelerator-Produced and Other Radioactive Material as Byproduct Material"—amended the AEA's Section 11e definition of byproduct material to add: ^{1, 3}

• any discrete source of radium-226 produced, extracted, or converted after extraction for a commercial, medical, or research activity;
• any material made radioactive by use of a particle accelerator and produced, extracted, or converted after extraction for such an activity; and
• any discrete source of naturally occurring radioactive material, other than source material, that the NRC determines would pose a threat similar to a discrete radium-226 source.

The NRC codified these in the regulatory definitions (for example, 10 CFR 30.4) and added a definition of "discrete source." ^{2, 3} A discrete source is a radionuclide that has been processed so that its concentration or form makes it usable for a commercial, medical, or research activity—as opposed to diffuse NARM in the ground or environment. ²

Why PET programs care

Accelerator-produced isotopes are the backbone of PET and several SPECT studies. The medical examples the NRC itself cited include F-18 for PET, Co-57 for flood sources, and Ga-67, In-111, I-123, and Tl-201 for imaging. ⁵ After the expanded definition, all of these are byproduct material and must be on a facility's radioactive material license. The physics of how they are made—covered next—explains both why they were historically "different" and why their short half-lives do not exempt them. For the broader jurisdictional map, see NRC, Agreement States, and FDA jurisdiction.

Key Technical Principles

How accelerators make these isotopes

A medical cyclotron accelerates charged particles—typically protons—to several MeV and drives them into a target. The induced nuclear reaction creates a proton-rich radionuclide that usually decays by positron emission or electron capture. The canonical PET example is:

a proton in, a neutron out, converting oxygen-18 in enriched water to fluorine-18. Gallium-68, by contrast, is eluted from a Ge-68/Ga-68 generator, but the parent Ge-68 is itself accelerator-produced—so generator-based Ga-68 is just as much accelerator-derived byproduct material as directly cyclotron-made F-18. This is why the regulatory reach extends past the isotopes made on-site to the accelerator-made parents behind the generators.

Short half-life, same jurisdiction

Accelerator-produced PET isotopes are short-lived. Their decay follows the standard law:

With F-18's half-life of about 110 minutes, a 370 MBq dose calibrated at injection falls, after two half-lives (about 220 minutes), to:

Gallium-68's half-life is even shorter, about 68 minutes. These short half-lives shape handling, waste, and dose-rate management—decay-in-storage is often trivial—but they have no bearing on the legal classification. The material is byproduct material from the moment it exists, and a facility must be licensed to possess and use it regardless of how fast it decays. A short half-life is a radiation-safety convenience, not a licensing exemption.

Clinical Impact

For a medical facility, the expanded definition changed the answer to three operational questions: who issues our license, which rules govern the material, and what must our radiation safety program cover. The material itself did not become more hazardous overnight; the regulatory framework became uniform.

• Licensing scope. A facility's radioactive material license must now authorize every accelerator-produced isotope it receives or produces, not just its reactor-produced inventory. A cyclotron or PET pharmacy operating under a patchwork of state NARM rules had to transition to byproduct-material licensing. ^{3, 6}
• Uniform radiation-protection rules. Accelerator-produced material is now subject to the byproduct-material framework—occupational and public dose limits, posting, surveys, and recordkeeping equivalent to 10 CFR Part 20, and the medical-use requirements equivalent to 10 CFR Part 35 (authorized users, written directives, and the like). ³
• Legacy sources. Older healthcare and academic facilities sometimes hold legacy radium-226 sources. These discrete sources became byproduct material and must be identified, secured, and dispositioned under the correct authority rather than left in a forgotten drawer. ^{1, 3}

For facilities building or amending a program around these isotopes, the licensing path connects to broader guidance in our NRC radioactive material license guide and, for larger programs, the NRC broad-scope medical license (Part 33).

Practical Optimization Tips

1. Confirm license coverage isotope by isotope

Pull the radioactive material license and verify that every accelerator-produced isotope in the workflow—F-18, Ga-68 and its Ge-68 generator, and any Ga-67/In-111/I-123/Tl-201/Co-57—is explicitly authorized at the needed possession limits. Gaps are a common amendment trigger.

2. Know your regulator

Determine whether the facility sits in an Agreement State or under direct NRC jurisdiction, because that dictates where the license lives, who inspects, and where reports go. Of the states DRPS serves, most are Agreement States; a few jurisdictions are regulated directly by the NRC.

3. Inventory legacy and NARM sources

Search for legacy radium-226 and other discrete NARM sources—old brachytherapy sources, check sources, historical devices. Document them and plan disposition under byproduct-material rules rather than assuming they are "grandfathered" out of regulation. See sealed source and device registration.

4. Align the radiation safety program

Ensure surveys, dose monitoring, waste (including decay-in-storage of short-lived PET isotopes), written directives, and recordkeeping meet the byproduct-material requirements for the accelerator-produced inventory, not just the reactor-produced side.

5. Build change into license management

New PET agents and new accelerator-made isotopes appear regularly. Treat license amendments as a routine, planned process so that adopting a new tracer does not outpace the authorization to possess it.

Common pitfalls

• Assuming a short half-life means no license is needed. It never did.
• Overlooking the Ge-68 parent behind a Ga-68 generator. Generator-based Ga-68 is accelerator-derived byproduct material.
• Leaving legacy radium sources undocumented. They are now byproduct material with security and disposition obligations.
• Confusing state NARM-era rules with current byproduct-material rules. The authority and the rule set changed in 2007.
• Adopting a new PET tracer before amending the license to authorize its isotope.

Regulatory Considerations

The expanded definition is federal law implemented through NRC regulation and administered by the NRC or Agreement States. The governing framework:

• Energy Policy Act of 2005, Section 651(e) — amended the AEA's Section 11e definition of byproduct material to add accelerator-produced material and certain discrete NARM sources. ^{1, 4}
• NRC final rule, 72 FR 55864 (published October 1, 2007; effective November 30, 2007) — implemented the statutory change across the regulations, revised the definition of byproduct material, and added "discrete source." ³
• 10 CFR 30.4 — the regulatory definition of byproduct material (and discrete source) as expanded. ²
• 10 CFR Part 20 and 10 CFR Part 35 — the radiation-protection and medical-use requirements that now apply to the newly defined material. ^{7, 8}
• NRC NUREG-1556, Volume 9 — program-specific guidance for medical-use licenses, including the isotopes authorized and the radiation safety program expected. ⁶

Jurisdiction splits by state: the 34 Agreement States maintained authority over the newly defined material under their agreements with the NRC, while the NRC assumed direct authority in the non-Agreement States, the District of Columbia, at federal facilities, and on recognized tribal lands. ³ Of the states DRPS serves, Florida, Maryland, Virginia, California, Nevada, Pennsylvania, New York, and New Jersey are NRC Agreement States that license and inspect the medical use of this material under their own radiation-control rules, while Washington, DC and Delaware are regulated directly by the NRC. A facility must confirm which authority issues its license before relying on any procedural assumption. DRPS supports this through radioactive material license support and PET/CT and nuclear medicine physics.

Frequently Asked Questions (FAQs)

What is accelerator-produced radioactive material?

Accelerator-produced radioactive material is any radioactive material created by a particle accelerator, such as a medical cyclotron. In nuclear medicine, common examples include fluorine-18 for PET, and gallium-67, indium-111, iodine-123, thallium-201, and cobalt-57, plus the accelerator-made parent isotopes used in some generators. Since the NRC's 2007 expanded-definition rule, this material is federal byproduct material under the Atomic Energy Act.

What does NARM stand for?

NARM stands for naturally occurring and accelerator-produced radioactive material. It historically described radioactive material that fell outside the Atomic Energy Act's definition of byproduct, source, or special nuclear material, and so was regulated by the states rather than the NRC. The Energy Policy Act of 2005 brought a defined subset of NARM—accelerator-produced material and certain discrete sources—under federal jurisdiction.

When did accelerator-produced material become NRC byproduct material?

The Energy Policy Act of 2005 amended the Atomic Energy Act's definition of byproduct material, and the NRC implemented the change through a final rule published on October 1, 2007 (72 FR 55864) that took effect on November 30, 2007. From that point, accelerator-produced radioactive material and certain discrete sources of radium-226 and other naturally occurring material became federal byproduct material.

Who regulates F-18 and other PET isotopes now?

In the 34 Agreement States, the state radiation-control program licenses and inspects medical use of these isotopes under agreements with the NRC. In the non-Agreement States, the District of Columbia, federal facilities, and on recognized tribal lands, the NRC regulates them directly. In every case the material is now treated as byproduct material under rules equivalent to 10 CFR Parts 20 and 35.

Does the short half-life of PET isotopes exempt them from licensing?

No. A short half-life changes the handling, decay-in-storage, and dose-rate picture, but it does not remove the material from the byproduct-material definition. A facility must still be licensed for the isotopes it receives or produces, follow medical-use and radiation-protection rules, and maintain the required radiation safety program, regardless of how quickly the activity decays.

What is a discrete source under the expanded definition?

A discrete source is a radionuclide that has been processed so that its concentration or physical form makes it usable for a commercial, medical, or research activity, as opposed to diffuse naturally occurring material in the environment. The expanded definition specifically brought discrete sources of radium-226 and certain other naturally occurring material under federal byproduct-material jurisdiction.

How should a medical facility respond to these rules?

A facility should confirm that its radioactive material license covers every accelerator-produced isotope it uses or produces, verify whether its state is an Agreement State or NRC-regulated, and ensure its radiation safety program, written directives, surveys, and waste handling meet the applicable byproduct-material requirements. Legacy radium or other NARM sources should be identified and dispositioned under the correct authority.

Key Takeaways

• Accelerator-produced and certain NARM material are now federal byproduct material. The 2005 Energy Policy Act and NRC's 2007 rule (72 FR 55864, effective Nov 30, 2007) made the change. ^{1, 3}
• PET depends on these isotopes. F-18, Ga-68 (via accelerator-made Ge-68), Ga-67, In-111, I-123, Tl-201, and Co-57 are all byproduct material. ⁵
• Short half-life is not an exemption. Decay helps with handling and waste, not with licensing. The material must be authorized on the license.
• Jurisdiction depends on the state. Agreement States license and inspect; the NRC regulates directly in non-Agreement States, DC, federal facilities, and tribal lands. ³
• Legacy radium sources came in from the cold. Discrete radium-226 sources are now byproduct material and must be identified and dispositioned properly. ^{1, 2}

Conclusion

The expanded definition of byproduct material is one of those regulatory changes that is invisible on a good day and decisive on a bad one. It did not make F-18 or a legacy radium needle more dangerous; it made the rules governing them uniform and federal, so that a PET program no longer straddles two regulatory worlds. For a medical facility, the practical work is unglamorous but important: confirm that the license authorizes every accelerator-produced isotope in use, know whether the NRC or an Agreement State holds the pen, and make sure the radiation safety program treats cyclotron-made material with the same rigor as reactor-made material.

The RSO and medical physicist who understand where their isotopes come from—and therefore which authority and which rules apply—will keep the program defensible as new tracers and new accelerator-produced agents continue to arrive. The physics of how these isotopes are made is also the key to understanding why they are regulated the way they are.

How DRPS Can Help

Diagnostic Radiation Physics Services helps imaging and nuclear medicine facilities keep their radioactive material programs aligned with the byproduct-material framework: license scope reviews for accelerator-produced isotopes, amendment support as new PET agents are adopted, legacy and NARM source identification and disposition planning, and radiation safety program documentation. This is delivered through radioactive material license support, radiation safety officer consulting, and PET/CT and nuclear medicine physics.

DRPS supports facilities across our service locations, including Florida, Maryland, Virginia, Washington DC, California, Nevada, New York, Pennsylvania, New Jersey, and Delaware.

Knowing where your isotopes come from is the first step to knowing which rules apply to them.

Related Resources

• NRC, Agreement States, and FDA jurisdiction
• NRC radioactive material license guide
• NRC broad-scope medical license (Part 33)
• Sealed source and device registration (SSD)
• Radioactive material license support
• Radiation Safety Officer consulting
• PET/CT and nuclear medicine physics

References

1. U.S. Congress. Energy Policy Act of 2005, Public Law 109-58, Section 651(e): Treatment of Accelerator-Produced and Other Radioactive Material as Byproduct Material. 2005. govinfo.gov
2. U.S. Nuclear Regulatory Commission. 10 CFR 30.4: Definitions (byproduct material; discrete source). ecfr.gov
3. U.S. Nuclear Regulatory Commission. Requirements for Expanded Definition of Byproduct Material. Final Rule. 72 FR 55864 (October 1, 2007; effective November 30, 2007), RIN 3150-AH84. federalregister.gov
4. U.S. Congress. Atomic Energy Act of 1954, as amended, Section 11e [42 U.S.C. 2014(e)]. nrc.gov
5. Mauer A. Status and Plans for Implementation of NRC Regulatory Authority for Certain Naturally Occurring and Accelerator-Produced Radioactive Material. J Nucl Med Technol. 2007;35(2):112-113. tech.snmjournals.org
6. U.S. Nuclear Regulatory Commission. NUREG-1556, Volume 9, Revision 3: Consolidated Guidance About Materials Licenses — Program-Specific Guidance About Medical Use Licenses. nrc.gov
7. U.S. Nuclear Regulatory Commission. 10 CFR Part 20: Standards for Protection Against Radiation. ecfr.gov
8. U.S. Nuclear Regulatory Commission. 10 CFR Part 35: Medical Use of Byproduct Material. ecfr.gov