2026 Regulatory Policy Analysis
NRC Medical-Use Reform:What Changes for Patient Safety?
ASRT recommendations, proposed NRC changes and the implications for medical imaging and radiation safety.
ASRT × NRC • Interactive policy brief
Less burden.
Reliable safeguards.
ASRT supports regulatory modernization. Its central request: preserve clear qualifications, documented verification and dose optimization as federal requirements change.
What is actually changing?
Compare the three issues raised in ASRT’s letter. Proposed changes must be distinguished from requirements already in force.
Who may qualify as a physician?
Modernize degree recognition without leaving physician-level qualifications unclear.
Degree + license
The definition combines an MD or DO degree with licensure to prescribe drugs in the practice of medicine. Authorized-user qualifications are additional requirements.
Source S4Remove the degree label
Remove “MD or DO” from the definition. The stated aim is to accommodate equivalently qualified, foreign-trained physicians whose degrees use other names.
Source S2Name the equivalent standard
Explicitly recognize equivalent foreign medical degrees and require medical licensure, so the definition preserves clear physician-level credentials.
Source S1Broader recognition could improve access. Clear equivalence criteria would help licensing teams apply the same standard across facilities.
Does this automatically authorize nurse practitioners or physician assistants?
Why would hospitals carry more responsibility?
The broader medical-use proposal would allow licensees to approve certain diagnostic authorized users internally without first obtaining a license amendment. That makes documented credential review and radiation safety officer verification especially important. This is a separate operational change, not a consequence of deleting degree names alone. S2
What happens before diagnostic I-131?
The change concerns diagnostic sodium iodide I-131 and its written-directive pathway.
Written directive above 30 μCi
For sodium iodide I-131 above 1.11 MBq (30 μCi), an authorized user must sign and date a written directive before administration, including diagnostic use. Linked procedures require identity and directive checks.
Source S4Use the diagnostic pathway
Move diagnostic sodium iodide I-131 to the non-written-directive diagnostic framework. This removes its written directive and the associated §35.41 verification procedures. Therapy directives remain.
Source S2Keep a documented check
Retain the written directive or an equivalent documented process that verifies the patient, radiopharmaceutical, activity and route before administration.
Source S1The practical decision is whether the removed federal workflow is replaced by an equally reliable local verification step.
What would remain, and what would change?
Other applicable dosage controls, recordkeeping and medical-event reporting would remain. Diagnostic I-131 would also follow a different diagnostic authorized-user pathway. The proposal does not eliminate every radiation-safety requirement or remove therapeutic written directives. S2
How strong is the NRC’s supporting evidence?
The proposal cites unit-dose practices and only one reported medical event in the previous decade involving doses that required a directive; the correct dosage was administered, but the directive was missing. That count has no procedure denominator or controlled comparison. It does not establish that removing the requirement is harmless, or that removal would cause harm. S2
What could an equivalent local safeguard include?
A durable record of patient identity, order and indication, drug, activity and route; an identified verifier; and a clear process for resolving discrepancies before administration. These are suggested local safeguards, not newly enacted NRC requirements. Professional practice guidance provides additional support for verification. S6
What replaces ALARA?
ALARA means “as low as reasonably achievable.” This issue comes from a separate radiation-protection proposal.
Optimization alongside limits
Part 20 requires radiation protection programs and, to the extent practical, procedures and controls that keep occupational and public doses ALARA.
Source S5Graded dose management
Replace ALARA terminology with a threshold-based, graded framework. The proposal retains dose controls and the linear dose-response model; it does not declare low-dose radiation risk-free.
Source S3Preserve ALARA in medical use
Move the ALARA definition into Part 35 to retain the principle for medical applications. The letter seeks continuing emphasis on dose optimization.
Source S1A definition alone may not create an enforceable duty. Effective preservation would identify responsible parties, covered exposures, required actions and documentation.
What is the potential organizational consequence?
Can Agreement States simply keep the existing ALARA requirement?
Do not assume so. The companion proposal assigns the revised §20.1101(b) a compatibility category that calls for essentially identical state provisions. State implementation must be evaluated against the final compatibility decisions. S3
Does this establish limits for patient imaging doses?
The opportunity
Less administrative delay, more flexible recognition of qualified physicians and streamlined diagnostic licensing.
The implementation risk
More responsibility may move to the licensee. Local controls and competency decisions could become less consistent without explicit standards.
The assessments above are reasoned implications, not measured outcomes. Neither ASRT’s letter nor the proposal establishes a numerical change in patient risk.
Where does your facility fit?
Select a service and regulatory setting for a tailored reading of the proposal. This guide identifies relevance, not legal eligibility.
Mixed nuclear medicine and therapy
The broadest exposure to the proposal: credentialing, diagnostic workflows and radiation protection all warrant review. Preserve the distinction between diagnostic I-131 and therapeutic administrations.
The transition is a sequence, not a switch
Final rule
Check the adopted text and what changed after comments.
Jurisdiction
Check effective dates, state adoption and compatibility.
Local controls
Update license-specific policies, privileges and training.
Verification
Monitor implementation and correct emerging gaps.
An MRI-only service does not use ionizing radiation. CT and X-ray devices are generally regulated through machine-radiation frameworks; they do not become Part 35 activities simply because they involve radiation. Hybrid PET/CT includes a radioactive-material component. Sources S2 S4 S9.
Turn the analysis into preparation
Use this checklist for internal review while proposals move through the regulatory process. These are recommended preparation steps, not new legal requirements.
Selections can be saved in this browser. Do not enter patient or confidential information.
Evidence you can inspect
Regulatory text establishes the proposal. ASRT’s letter states its position. Research and guidance inform the analysis, with limits made explicit.
9 sources
ASRT comment letter
September 10, 2026 • NRC-2025-1237
Supplied letter. Recommends clearer physician credentials, continued diagnostic I-131 verification, and preservation of ALARA in medical use.
Primary stakeholder recommendation; the letter is not an NRC rule.NRC: Reducing Barriers to Medical Use Licensing ↗
Proposed rule • July 27, 2026 • 91 FR 47042–47100
Medical-use proposal covering physician definitions, diagnostic sodium iodide I-131, authorized users, training, licensing and waste provisions.
Use the final adopted text and effective date before changing a licensed program.NRC: Reforming and Modernizing the Radiation Protection Framework ↗
Proposed rule • July 15, 2026 • 91 FR 43456–43504
Separate proposal replacing ALARA terminology with graded dose management, while retaining dose controls and the linear dose-response model.
Distinct docket: NRC-2025-1140. Related to, but not part of, the medical-use proposal.10 CFR Part 35: Medical Use of Byproduct Material ↗
Existing regulatory framework
See physician definition (§35.2), written directives (§35.40), administration procedures (§35.41), and diagnostic authorized-user provisions.
This link opens a live regulation page; the infographic itself is a September 26, 2026 snapshot.10 CFR Part 20: Standards for Protection Against Radiation ↗
Existing regulatory framework
Radiation protection programs and ALARA; occupational and public exposure controls. Patient medical exposure is not subject to these occupational/public dose limits.
Do not apply occupational or public dose limits as diagnostic patient dose limits.SNMMI/ACNM practice guideline: Use of Radiopharmaceuticals 5.0 ↗
Weatherman et al. • 2025 • Journal of Nuclear Medicine Technology 53(2), 130–134
Professional guidance supports radiopharmaceutical preparation and verification practices, including activity and route.
Practice guidance, not an experiment measuring the effect of removing a federal written directive.INWORKS: Ionising radiation and solid cancer mortality ↗
Richardson et al. • 2023 • BMJ 382, e074520
Observational occupational cohort informs discussion of cumulative low-dose exposure and protection.
Does not quantify the patient risk of this NRC proposal or test removal of an I-131 directive.Human error: Models and management ↗
Reason • 2000 • BMJ 320, 768–770
Systems-safety framework helps explain why independent checks and documented handoffs can matter.
Conceptual safety analysis; not direct evidence of the proposed rule’s outcomes.NRC jurisdiction: Kansas ↗
Agreement State context
Kansas regulates covered radioactive-material uses through its Agreement State program. State implementation and compatibility requirements matter.
A federal proposal is not itself permission to change a Kansas license condition or procedure.What else is in the medical-use proposal?
The proposal also addresses training pathways for certain residency-trained specialists, continuing education, recognition of emerging uses, selected reporting requirements and decay-in-storage. The proposed physical half-life ceiling for decay-in-storage would rise from 120 to 275 days; this would not make waste automatically releasable.
The NRC models $39.1 million in undiscounted national savings for 2027–2031 across the full medical-use rule, including $30.5 million for licensees. These are forecasts, not measured savings or a budget estimate for an individual hospital. S2
Radiation-protection proposal
Medical-use proposal
ASRT letter; medical-use comments close
This analysis reviewed