NRC Broad Scope Licenses: Types A, B, and C

A broad scope license, issued under 10 CFR Part 33, lets an institution add radionuclides, uses, and authorized users through its own Radiation Safety Committee instead of filing a separate NRC amendment for every change — but the authority is graded into Types A, B, and C that differ in quantity limits, committee requirements, and the depth of program required. The trade is straightforward in principle: the NRC delegates day-to-day licensing decisions to the institution, and in return the institution must run a mature, documented radiation-safety program capable of making those decisions safely.¹²

For an academic medical center, a large hospital system, or a research institution, understanding where a program sits — or should sit — on the limited-specific-to-broad-scope spectrum is a strategic decision with real operational and compliance consequences. This guide explains what Part 33 authorizes, how the three types differ, the pivotal role of the Radiation Safety Committee, a worked possession-limit example, and how to earn and keep broad scope authority. DRPS supports this work through radioactive material license support and radiation safety officer services.

Introduction

Every use of byproduct material in medicine or research happens under a license. The most common arrangement is a limited specific license: the license names each radionuclide, each authorized use, and each authorized user, and the licensee must apply to the NRC or its Agreement State to amend the license before adding any of them.³ For a small imaging center or a single-service nuclear medicine department, that model is entirely workable — changes are infrequent, and the amendment turnaround is tolerable.

For a large institution, the limited-specific model becomes a bottleneck. An academic medical center may bring on new authorized users, adopt new radiopharmaceuticals, and launch research protocols continuously; waiting for a license amendment before each one is slow and administratively heavy.² The broad scope license under 10 CFR Part 33 exists precisely to relieve that bottleneck by moving much of the decision-making inside the institution, to a Radiation Safety Committee and Radiation Safety Officer who review and approve changes within the boundaries the license sets.¹²

That relief is not free. Broad scope authority is granted only to licensees that demonstrate the experience, staffing, and program maturity to exercise it safely, and it raises the bar for the internal radiation-safety program. This article is written for the RSOs, administrators, and physicists who have to decide whether broad scope is right for their institution and how to run it well. DRPS supports these programs across Florida, Maryland, Virginia, Washington DC, California, Nevada, Pennsylvania, New York, New Jersey, and Delaware.

Topic Explanation

What Part 33 authorizes

10 CFR Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material," establishes three categories of broad scope license — Type A, Type B, and Type C — each authorizing multiple radionuclides and uses without the item-by-item specificity of a limited license.¹ The defining feature is delegated authority: within the scope the license grants, the licensee's own internal governance (chiefly the Radiation Safety Committee and RSO) approves new uses and users, rather than the regulator doing so through amendments.¹²

The three types form a hierarchy of authority and quantity:

• Type A (10 CFR 33.13) authorizes the broadest program and the largest quantities — those listed in Column I of Schedule A (10 CFR 33.100). A Type A license requires both a Radiation Safety Committee and a Radiation Safety Officer.¹
• Type B (10 CFR 33.14) is limited to the smaller per-radionuclide quantities in Column II of Schedule A. Its authorized scope is tied to the knowledge and experience of the RSO, and it does not require a formal committee.¹
• Type C (10 CFR 33.15) is limited to the still-smaller Column III quantities and is restricted to research and development. It is the entry-level broad scope authority and, like Type B, does not require a committee.¹

The general requirements common to all three — the application, recordkeeping, and license conditions — appear in 10 CFR 33.11, 33.12, and 33.17, and the quantity tables that define the three tiers are in Schedule A at 10 CFR 33.100.¹ Program-specific NRC guidance for preparing a broad scope application is consolidated in NUREG-1556, Volume 11.²

Why the Radiation Safety Committee is central

Under a broad scope license, the Radiation Safety Committee is the body to which the NRC effectively delegates licensing judgment. For a Type A license, the committee must review and approve — before use — proposed authorized users, proposed uses of byproduct material, and the associated radiation-safety procedures.¹² It is, in a real sense, the institution's internal licensing authority operating within the boundaries the NRC set.

A functioning committee typically includes the RSO, a representative of management, and authorized users spanning the institution's principal uses of byproduct material, and it meets on a defined schedule with documented minutes.² The quality of this committee is what makes broad scope authority defensible: if the committee is a rubber stamp, the delegated authority is being exercised carelessly, and that is exactly what an inspector will probe. For how the committee fits alongside the RSO and the wider program, see our guides to the Radiation Safety Committee and the Radiation Safety Officer role.

Broad scope in the medical context

For medical use specifically, Part 33 interacts with 10 CFR Part 35. A broad scope medical license lets the institution's Radiation Safety Committee authorize qualified physicians as authorized users and approve new medical uses within the license's scope, without filing a separate NRC amendment for each addition.¹³ Under a limited specific medical license, by contrast, each new authorized user or new use generally requires an amendment and the associated review time.³ That difference — internal committee approval versus external amendment — is the single most consequential practical distinction for a growing medical program.²³

Key Technical Principles

The quantity tiers and Schedule A

The three broad scope types are separated by the quantities in Schedule A (10 CFR 33.100), which lists, radionuclide by radionuclide, three columns of activity thresholds. Column I quantities (the largest) define Type A eligibility; Column II defines the Type B ceiling per radionuclide; Column III (the smallest) defines the Type C ceiling.¹ The practical effect is that Type A is chosen by institutions that need large aggregate possession across many radionuclides, while Types B and C serve narrower or smaller programs.

Because a broad scope license authorizes possession up to defined limits across a portfolio of radionuclides, the licensee must be able to demonstrate at any time that its aggregate possession stays within the authorized envelope. When several radionuclides are held simultaneously against individual limits, the standard way to express compliance is a sum-of-fractions (unity) rule.

Worked example: the sum-of-fractions possession check

Let $Q_i$ be the activity of radionuclide $i$ a licensee possesses, and $L_i$ the authorized possession limit for that radionuclide under the license. The aggregate possession is within limits when:

Consider an illustrative program holding four radionuclides against the following authorized limits (these limit values are illustrative for the arithmetic, not quoted Schedule A quantities):

Summing the fractions:

The program is within its authorized envelope, but only just — at 95% of the aggregate limit, there is little headroom to add a new high-activity service without either raising the license limits or reducing another holding. This is exactly the kind of forward-looking check a Radiation Safety Committee should run before approving a new use, and it is why programs anticipating growth often seek Type A authority with generous Column I limits rather than repeatedly bumping against a tighter ceiling.¹²

Comparison of the three broad scope types

All three still operate within the general byproduct-material framework of 10 CFR Part 30 and the radiation-protection standards of 10 CFR Part 20, and — for medical use — the requirements of 10 CFR Part 35.¹³⁴⁵

Clinical Impact

Broad scope authority changes how fast and how flexibly an institution can grow its radiation-based services. A cancer center standing up a new theranostics program, a research hospital adding investigational radiopharmaceuticals, or a health system onboarding several new nuclear medicine physicians can move at the speed of its own committee rather than the speed of an external amendment queue.²³ That agility is a genuine clinical and competitive advantage — new services reach patients sooner.

But the same delegation concentrates responsibility. Every approval the Radiation Safety Committee grants is one the NRC did not review in advance, so the institution owns the consequences if an authorization is unsupported, a training-and-experience determination is weak, or a safety procedure is inadequate.² Broad scope licensees are therefore held to a high standard at inspection: inspectors examine committee minutes, authorized-user qualifications, audit findings, and the program's self-governance to confirm the delegated authority is being exercised with rigor.² For the failure modes that most often surface, see common radiation safety violations and how to avoid them and how to prepare for an NRC inspection.

Practical Optimization Tips

Deciding whether to pursue broad scope

• Match the license to the trajectory. If the program adds users and uses only occasionally, a limited specific license may be simpler. If it is growing continuously, the amendment burden is a strong argument for broad scope.²³
• Build the track record first. Because broad scope is rarely granted to a new applicant, operate a clean limited specific program with documented audits and a good compliance history before applying.²
• Right-size the type. Not every institution needs Type A. A focused program may be well served by Type B, and a research-only operation by Type C, each with a lighter governance footprint.¹

Running a broad scope program well

• Make the Radiation Safety Committee real. Charter it, populate it across the institution's uses, meet on schedule, keep substantive minutes, and require genuine pre-use review of new users and uses.¹²
• Document training-and-experience determinations rigorously. When the committee authorizes a physician as an authorized user, the file must show the basis, because the NRC is trusting that judgment. See our guide to authorized user training and experience.
• Track aggregate possession against license limits using a sum-of-fractions check, and forecast headroom before approving high-activity additions.¹
• Audit the program annually and treat findings as the committee's business, not just the RSO's. A strong internal audit is the best preparation for an external inspection. See the annual radiation protection program audit.

Common pitfalls

• Treating broad scope as "less regulation." It is not less — it is delegated regulation, with the review burden moved inside the institution.²
• A committee that rubber-stamps. Undocumented or perfunctory approvals undermine the entire basis of the license.²
• Losing track of aggregate limits when many services draw on the same portfolio of radionuclides.¹
• Weak authorized-user files that cannot support the committee's determinations at inspection.²

Regulatory Considerations

Broad scope licensing sits within the full NRC byproduct-material framework, and in Agreement States within the compatible state framework.¹⁶ The key references are:

• 10 CFR Part 33 — the broad scope rule itself, defining Types A, B, and C, the application and program requirements, and Schedule A quantities.¹
• 10 CFR Part 30 — the general rules for domestic licensing of byproduct material that underlie all specific licenses.⁴
• 10 CFR Part 20 — Standards for Protection Against Radiation, setting the occupational and public dose limits and ALARA expectations the program must meet.⁵
• 10 CFR Part 35 — Medical Use of Byproduct Material, which governs medical authorized users, written directives, and the medical RSO, and which a broad scope medical license operates in conjunction with.³
• NUREG-1556, Volume 11 — the NRC's consolidated guidance for preparing and maintaining a broad scope license application, including the expectation of prior experience and a committee structure.² For medical-use specifics, NUREG-1556, Volume 9 provides parallel medical licensing guidance.⁷

Agreement States administer equivalent programs. Of the states DRPS serves, Florida, Maryland, Virginia, California, Nevada, Pennsylvania, New York, and New Jersey are Agreement States that license broad scope authority under their own compatible regulations, while Washington DC and Delaware are regulated directly by the NRC.⁶ A licensee must confirm which authority issues, amends, and inspects its license before relying on any specific provision, and should coordinate broad scope planning with radioactive material license support and RSO program guidance.

Frequently Asked Questions (FAQs)

What is a broad scope radioactive material license?

A broad scope license, issued under 10 CFR Part 33, authorizes a licensee to use multiple radionuclides for a range of purposes and to make many changes — adding radionuclides, uses, and authorized users within the license's scope — through its own internal Radiation Safety Committee rather than by filing a separate NRC license amendment for each change. It is designed for institutions with the experience and safety infrastructure to manage that decision-making authority responsibly.

What is the difference between Type A, Type B, and Type C broad scope licenses?

The three types differ in the quantities they authorize and the program they require. Type A (10 CFR 33.13) authorizes the largest quantities, listed in Schedule A Column I, and requires a Radiation Safety Committee and a Radiation Safety Officer. Type B (10 CFR 33.14) is limited to the smaller quantities in Schedule A Column II and its scope is tied to the knowledge and experience of the RSO. Type C (10 CFR 33.15) is limited to the still-smaller Column III quantities and to research and development, and it does not require a committee.

Does a broad scope license require a Radiation Safety Committee?

A Type A broad scope license requires an established Radiation Safety Committee to review and approve proposed uses of byproduct material, authorized users, and safety procedures. Type B and Type C licenses require a qualified Radiation Safety Officer but do not require a formal committee. Even where a committee is not mandated, a strong RSO and documented review process are expected.

Can a new licensee get a broad scope license?

It is uncommon. NRC guidance in NUREG-1556 Volume 11 explains that because a broad scope license transfers significant decision-making authority to the licensee, it is not normally issued to a new applicant. Institutions typically operate for several years under a limited specific license with a good compliance history before applying for broad scope authority.

How does a broad scope medical license change how authorized users are added?

Under a limited specific medical license, adding a new authorized user or a new medical use generally requires filing an amendment and waiting for NRC or Agreement State approval. Under a broad scope medical license, the institution's Radiation Safety Committee can authorize qualified physicians and approve new uses within the scope of the license without a prior amendment for each change, which greatly speeds up program growth while placing the review burden on the internal committee.

Who regulates a broad scope license in an Agreement State?

In an Agreement State, the state radiation-control program administers an equivalent broad scope licensing framework under its own regulations, which are compatible with the NRC rules. Of the states DRPS serves, Florida, Maryland, Virginia, California, Nevada, Pennsylvania, New York, and New Jersey are Agreement States, while Washington DC and Delaware are regulated directly by the NRC. A licensee must confirm which authority issues and inspects its license.

Key Takeaways

• Broad scope means delegated licensing. Part 33 lets an institution add radionuclides, uses, and users through its own committee instead of an NRC amendment for each change.¹²
• Three tiers, three programs. Type A (Column I, committee required) is the broadest; Type B (Column II) is RSO-scoped; Type C (Column III) is research-only.¹
• The Radiation Safety Committee is the linchpin of a Type A license and the body inspectors scrutinize most closely.¹²
• Aggregate possession must stay within limits, best tracked with a sum-of-fractions unity check before approving new high-activity services.¹
• Broad scope is earned, not defaulted. A clean limited-specific track record and good compliance history come first.²
• Agreement State or NRC — confirm the issuing authority; most DRPS-served states are Agreement States, but DC and Delaware are direct-NRC.⁶

Conclusion

A broad scope license is best understood not as looser regulation but as a transfer of licensing responsibility from the regulator to the institution. In exchange for the freedom to add radionuclides, uses, and authorized users through its own Radiation Safety Committee, a broad scope licensee accepts the obligation to run a mature, well-documented, self-governing radiation-safety program — and to prove, at every inspection, that its internal decisions are sound. For a growing academic medical center or health system, that trade is often well worth making. The institutions that thrive under broad scope authority are the ones that treat their committee, their RSO, and their documentation as the real license — because, in practice, they are.

How DRPS Can Help

Diagnostic Radiation Physics Services helps institutions evaluate, apply for, and operate under limited specific and broad scope radioactive material licenses. Our support includes radioactive material license support and application preparation, radiation safety officer services and program development, Radiation Safety Committee charters and audit support, and training program review — delivered by board-certified medical physicists across our service locations, including Florida, Maryland, Virginia, Washington DC, California, Nevada, Pennsylvania, New York, New Jersey, and Delaware.

A broad scope license is a powerful tool. We help institutions earn it, run it well, and defend it at inspection.

Related Resources

• The Radiation Safety Committee
• The Radiation Safety Officer role
• Authorized user and medical physicist training and experience
• Preparing for an NRC inspection
• The annual radiation protection program audit
• Radioactive material license support
• Radiation Safety Officer consulting

References

1. U.S. Nuclear Regulatory Commission. 10 CFR Part 33: Specific Domestic Licenses of Broad Scope for Byproduct Material. nrc.gov
2. U.S. Nuclear Regulatory Commission. NUREG-1556, Volume 11, Revision 1: Consolidated Guidance About Materials Licenses — Program-Specific Guidance About Licenses of Broad Scope. nrc.gov
3. U.S. Nuclear Regulatory Commission. 10 CFR Part 35: Medical Use of Byproduct Material. nrc.gov
4. U.S. Nuclear Regulatory Commission. 10 CFR Part 30: Rules of General Applicability to Domestic Licensing of Byproduct Material. nrc.gov
5. U.S. Nuclear Regulatory Commission. 10 CFR Part 20: Standards for Protection Against Radiation. nrc.gov
6. U.S. Nuclear Regulatory Commission. Agreement State Program. nrc.gov
7. 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
8. U.S. Nuclear Regulatory Commission. NRC Form 313: Application for Materials License. nrc.gov