Regulatory analysis | 10 CFR Part 35 | Docket NRC-2025-1237
Less Prescription, More Responsibility
The NRC’s proposed medical licensing reform, the American Society of Radiologic Technologists’ response, and where radiation safety accountability lands if the rule proceeds.
- Comments closed Sept 10, 2026
- 16 major provisions
- Final rule deadline Nov 23, 2026
- Kelly Emrick, DHSc, PhD, MBA, BSRT(ARRT)R
The bottom line
ASRT does not oppose the NRC’s deregulatory rule. It accepts burden reduction in principle and draws three lines: keep authorized user status tied to physicians, keep a documented safety check before diagnostic I-131 is administered, and preserve ALARA inside Part 35.
Behind all three sits one warning. When federal rules become less prescriptive, responsibility for safety moves quietly toward institutions and the technologists who administer the dose.
16
major provisions in the proposed Part 35 rule
$39.1M
projected net savings, 2027 to 2031, undiscounted
20M+
U.S. patients a year undergo procedures using byproduct material
35 of 45
comment days overlapped with the separate ALARA rule’s window
155,000+
technologists and therapists represented by ASRT
74 days
from comment close to the executive order’s final rule deadline
Where responsibility lands
Six safeguards that the federal rule prescribes today, and where each one would sit under the proposals. Nothing is abolished outright. Each check moves to a layer that varies more from one site to the next.
Federal rule
Uniform, reviewed by the NRC or an Agreement State before use
State law
Varies by jurisdiction
Physician definition
Eligibility turns on each state’s prescribing categories
Institution policy
Documented locally, checked at inspection
Diagnostic AU approval
Internal sign-off replaces a license amendment
Fixed training hours
Residency completion plus attestation
Recentness of training
Continuing education records kept on site
ALARA optimization *
Voluntary unless written into local policy
Point of care
The technologist administering the dose
Diagnostic I-131 written directive
The pre-administration check becomes local practice
* ALARA would be removed by the separate companion rule, “Reforming and Modernizing the NRC’s Radiation Protection Framework” (91 FR 43456), not by the Part 35 rule itself. Placement of each safeguard is the author’s reading of the proposed text.
Three rules, overlapping clocks
ASRT’s process objection is visible on the calendar. The Part 35 rule opened while the ALARA rule was still taking comments, and the two windows ran side by side for five weeks.
1
Keep AUs physicians
Recognize a foreign medical degree equivalent to an MD or DO plus a state medical license, rather than any individual with prescribing authority.
2
Keep an I-131 check
Retain the written directive, or at minimum a documented verification of patient, drug, activity, and route before administration.
3
Protect ALARA in Part 35
Move the ALARA definition into the medical use rule so it survives removal from Part 20.
What the NRC proposed
“Reducing Barriers to Medical Use Licensing” (91 FR 47042, July 27, 2026) responds to Executive Order 14300, which directed a wholesale revision of NRC regulations. The NRC describes it as a deregulatory action that would reduce prescriptive requirements, codify mature emerging technologies, and ease training and experience burdens. Filter the sixteen major provisions below.
Showing 16 of 16 provisions
1
Broaden the definition of “physician”
Removes the MD or DO requirement. Any individual licensed by a state or territory to prescribe drugs in the practice of medicine could qualify, so foreign-trained physicians with other degree titles can become AUs.
2
Replace the seven-year recentness rule
A performance-based continuing education requirement replaces the rule that training must be recent at the time of application, with records kept by the licensee. Generator elution work experience is removed.
3
Approve diagnostic AUs internally
No license amendment would be needed to add an AU for uptake, dilution, excretion, imaging, or localization studies. The licensee verifies and documents qualifications; regulators review at inspection.
4
Residency pathway without fixed hours
Physicians completing a clinical radiation specialty residency would qualify through the residency plus a preceptor or program director attestation. Board and alternate hour-based pathways remain.
5
Route-based therapy categories
Experience categories become “oral” and “parenteral” administration of any radioactive drug requiring a written directive, replacing dose-specific I-131 case counts so future radiopharmaceuticals fit.
6
Consolidate board certification rules
Specialty board approval moves to a new section, named accrediting bodies are removed from residency requirements, and supervised work experience may occur at any licensed facility under an AU.
7
Codify mature emerging technologies
Modern gamma stereotactic radiosurgery units, ophthalmic beta sources, generators, and microsources such as Y-90 microspheres move out of case-by-case licensing into standing rules, including a new Subpart I.
8
Clear rules for Rb-82 generators
Defines breakthrough, allows calibration flexibility for automated infusion systems, and codifies enforcement guidance that has provided interim relief since 2013.
9
Drop the written directive for diagnostic I-131
Diagnostic sodium iodide I-131 above 30 microcuries is the only diagnostic use that requires a written directive today. The NRC would move it to the diagnostic subpart, citing unit-dose capsules and more than 50 years of experience.
10
Narrow medical event reporting
Excludes events caused by emergent patient conditions or real-time clinical decisions, while keeping reporting for equipment defects and unintended harm.
11
Refine embryo and fetus dose reporting
Excludes cases where pregnancy could not reasonably be determined before administration.
12
Expand decay-in-storage
Raises the eligible half-life from 120 to 275 days so longer-lived isotopes such as Lu-177m and Co-57 can decay on site before disposal.
13
Fewer amendments for research
No license amendment for human subject research already approved by an Institutional Review Board and covered by existing medical use authorizations.
14
Simplify mobile medical services
Removes duplicative requirements for mobile services and aligns them with general radiation safety regulations.
15
Temporary RSO and committee changes
Extends how long a temporary Radiation Safety Officer may serve and focuses Radiation Safety Committee oversight on higher-risk therapeutic uses.
16
Remove outdated provisions
Strips obsolete survey requirements, waiver clauses, and recordkeeping items across Part 35, and makes minor editorial corrections.
Who the savings reach
The NRC’s regulatory analysis, five-year totals, undiscounted.
The companion rules
Part 35 is one of several Executive Order 14300 rulemakings that touch medical use.
- Modernizing NRC Regulations for Byproduct Material Use
- Published May 18, 2026. Creates optional standard general licenses for certain low-risk diagnostic uses; therapy requiring a written directive stays on the specific license track.
- Reforming and Modernizing the NRC’s Radiation Protection Framework
- Published July 15, 2026. Would retire ALARA in favor of a “graded approach to dose management” tied to dose thresholds, keep existing dose limits, and add a planned extension mechanism for exceeding an annual occupational limit within multi-year limits.
- Reducing Barriers to Medical Use Licensing
- Published July 27, 2026. The Part 35 rule on this page, and the subject of ASRT’s letter.
The letter
On September 10, 2026, the closing day of the comment period, the American Society of Radiologic Technologists filed comments on Docket NRC-2025-1237, addressed to NRC Chairman Ho Nieh. ASRT represents more than 155,000 medical imaging technologists and radiation therapists.
The letter accepts the NRC’s goal of reducing unnecessary burden and improving patient access. It then targets two provisions directly, the physician definition and the diagnostic I-131 written directive, restates a recommendation made on the separate ALARA rule, and raises two process concerns.
ASRT’s central warning
“When federal requirements become less prescriptive, responsibility migrates toward institutional policies and the professionals implementing them, reinforcing inconsistent safety protocols across the country.”
ASRT comment letter, September 10, 2026
Four recommendations, one at a time
Each card sets the NRC’s proposal against ASRT’s ask and traces what follows either way. The likelihood rating is the author’s assessment, not ASRT’s or the NRC’s.
§35.2, definition of “physician”
NRC proposes
Replace “a medical doctor or doctor of osteopathy” with “an individual” licensed to prescribe drugs in the practice of medicine, so foreign-trained physicians without an MD or DO can become AU-eligible if they meet training and experience criteria.
ASRT asks
Do not remove physician-level qualification. Recognize a foreign medical degree equivalent to an MD or DO, combined with state licensure to practice medicine, consistent with how HHS programs and the VA distinguish physicians from other practitioners.
If the NRC agrees
The NRC’s goal is met with almost no cost. The definition stays anchored to a medical degree, and eligibility reads the same in every state.
If the NRC declines
Eligibility turns on state prescribing categories, which differ. Because diagnostic AUs would be approved internally, a loose reading would be caught at inspection, after someone is already supervising.
Compare the wording
Current §35.2“Physician means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.”
Proposed §35.2“Physician means an individual licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.”
Illustrative wording based on ASRT’s recommendation“Physician means a medical doctor, a doctor of osteopathy, or the holder of a foreign medical degree equivalent to either, licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice medicine.”ASRT did not propose regulatory text. This sentence illustrates its recommendation.
Likelihood: highASRT’s fix achieves exactly what the NRC says it wants, so it is the recommendation most likely to be adopted.
§35.40, written directive for diagnostic sodium iodide I-131
NRC proposes
Remove the written directive for diagnostic I-131 above 30 microcuries and move it to the diagnostic subpart. The NRC cites unit-dose capsules, more than 50 years of operating experience, and PET having shifted where diagnostic risk sits.
ASRT asks
Keep the written directive. If the NRC proceeds anyway, require documented verification of the patient, radiopharmaceutical, prescribed activity, and route of administration before the dose is given.
If the NRC agrees
The technologist keeps a signed or documented order to check against, and the check reads the same everywhere. Burden falls only slightly compared with today.
If the NRC declines
The last independent check becomes whatever local policy says. Large systems will likely keep a directive-style order; smaller sites may not. I-131 is the same isotope used in therapy, so a capsule mix-up falls on the thyroid.
ASRT’s counterargument
“The limited number of reported events may also reflect the effectiveness of existing safeguards rather than demonstrate that those safeguards are unnecessary.” Reporting data alone cannot settle this either way. It is a fair caution, not proof.
Likelihood: moderateKeeping the full directive is unlikely. The verification fallback is a reasonable middle ground and could appear in the final rule or in guidance.
Move the ALARA definition into Part 35
NRC proposes
In the companion radiation protection rule, retire ALARA, which the NRC frames as resting on the linear no-threshold model, and replace it with a graded approach to dose management tied to dose thresholds.
ASRT asks
Reiterating its comment on that rule, move the ALARA definition into 10 CFR 35 to protect it for medical imaging and radiation therapy.
If the NRC agrees
Medicine keeps a federal optimization principle. In medicine, patient dose has no regulatory limit, so optimization is the principle that actually does the work.
If the NRC declines
ALARA survives in professional education and accreditation but loses regulatory force, weakening the tool radiation safety officers use to justify shielding, investigation levels, and monitoring budgets.
Likelihood: lowA medical carve-out would sit in tension with the NRC’s scientific rationale for retiring the term.
A transparent channel after the final rule
The concern
Overlapping comment periods for several NRC reforms limited stakeholders’ ability to evaluate the cumulative impact and spot unintended consequences.
ASRT asks
Establish a transparent mechanism for ongoing feedback on implementation problems, and be ready to issue guidance, clarifications, or correction notices.
If the NRC agrees
Implementation errors get a defined route to correction rather than surfacing one inspection at a time.
If the NRC declines
Problems still reach the agency through inspections, event reports, and advisory committee meetings, but slowly and unevenly.
Likelihood: moderateThe executive order sets a November 23, 2026 deadline for final rules, 74 days after this docket closed. That leaves little time to reconcile comments, which makes correction notices realistic.
The diagnostic I-131 safety chain
Six steps between the order and a completed diagnostic I-131 study. Choose a scenario to see which steps federal rules still require and where the check falls to local policy.
1
federal checks before administration
The technologist verifies against the order under local policy. No federal pre-administration check specific to I-131 remains.
1
Authorized user orders the study
The AU directs the diagnostic administration.
CurrentFederal requirement
NRC proposalFederal requirement
ASRT fallbackFederal requirement
2
Signed, dated written directive
Required today for diagnostic I-131 above 30 microcuries, the only diagnostic use with this rule.
CurrentFederal requirement
NRC proposalRemoved
ASRT fallbackRemoved, replaced by step 3
3
Verification before administration
Confirming the right patient, drug, activity, and route against the AU’s intent.
CurrentFederal requirement, via written directive procedures
NRC proposalLocal policy
ASRT fallbackFederal requirement, documented four-point check
4
Dosage determined before use
Activity of each dosage measured or decay-corrected and recorded.
CurrentFederal requirement
NRC proposalFederal requirement
ASRT fallbackFederal requirement
5
Pregnancy and breastfeeding screening
Standard practice before any iodine administration, but not a Part 35 pre-administration rule.
CurrentLocal policy
NRC proposalLocal policy
ASRT fallbackLocal policy
6
Medical event reporting
Wrong patient, drug, or route, or a dose outside set thresholds, must be reported.
CurrentFederal, measured against the written directive
NRC proposalFederal, measured against the AU’s directions
ASRT fallbackFederal, measured against the AU’s directions
- Federal requirement
- Local policy decides
- Removed
Step statuses are the author’s reading of current 10 CFR 35.40, 35.41, 35.63, and 35.3045 and the proposed rule text. Under the proposal, diagnostic I-131 would follow the same rules as other diagnostic radiopharmaceuticals, where the prescribed dosage is set by the AU’s directions rather than a written directive.
Why the directive has caught errors
A 2007 Minnesota Department of Health notice cited eleven I-131 administrations made without a required written directive, which it tied to staff not recognizing when one was needed. The directive was the mechanism that exposed those verification failures.
The NRC’s side, fairly stated
Prepackaged unit-dose capsules genuinely reduce handling and compounding errors, and diagnostic PET agents carry comparable risk without any written directive. The disagreement is about where the last check belongs, not whether I-131 is safe.
Who would meet the physician definition?
Select a profile to see how each version of §35.2 treats it. Meeting the definition is only the first gate: every AU still needs Part 35 training and experience plus board certification or a preceptor attestation.
| Profile | Current rule | NRC proposal | ASRT approach |
|---|---|---|---|
| U.S.-trained MD or DO with a state medical license | Meets | Meets | Meets |
| Foreign-trained physician (for example, MBBS) with a full U.S. state medical license | Does not meet | Meets | Meets |
| Nurse practitioner with independent prescribing authority | Does not meet | Unclear | Does not meet |
| Physician assistant with delegated prescribing authority | Does not meet | Unclear | Does not meet |
| Dentist or podiatrist | Separate pathway | Separate pathway | Separate pathway |
U.S.-trained MD or DO. No change under any version. These physicians meet the definition today and would continue to.
Foreign-trained physician. This is the group the NRC set out to include, and the one change all parties support. ASRT’s approach reaches the same physicians by recognizing an MD or DO equivalent degree.
Nurse practitioner. The proposed text requires a license to prescribe “in the practice of medicine.” Most states authorize nurse practitioner prescribing under nursing law, so many would read this as excluded, but the text does not settle it. That ambiguity is ASRT’s core objection.
Physician assistant. Prescribing authority is usually delegated or collaborative and defined differently by each state. Whether that counts as a license to prescribe in the practice of medicine is left to interpretation under the proposal.
Dentist or podiatrist. Part 35 already names dentists and podiatrists alongside physicians in the definition of authorized user. The physician definition change does not affect them.
Is your department ready if the rule proceeds?
Nine questions for imaging and nuclear medicine leaders. Each one keeps a safeguard in local policy that the federal rule may stop requiring. Answer honestly; your answers stay in this browser tab and are not saved or sent anywhere.
HighDiagnostic I-131 orders carry a written directive or an equivalent signed order, regardless of the final federal rule.
HighTechnologists document a four-point check of patient, radiopharmaceutical, activity, and route before every I-131 administration.
HighPregnancy and breastfeeding status is screened and documented before every radioiodine administration.
HighA written procedure governs internal approval of diagnostic AUs, and each approval file is ready for an inspector.
HighALARA, investigation levels, and dose reviews are written into the radiation safety committee charter, not only into federal rules.
MediumPolicy defines “physician” for AU eligibility as an MD, DO, or foreign equivalent with a state medical license.
MediumContinuing education records exist for every AU, specific to the uses each one supervises.
MediumSomeone owns tracking whether your regulator is the NRC or an Agreement State, and when the changes take effect for you.
MediumTechnologists can pause or escalate an administration they question, without penalty.
Know your regulator
Timing depends on who licenses you. In an Agreement State, the state radiation control program adopts NRC changes on its own schedule and may keep stricter rules where compatibility allows. Where the NRC regulates directly, the final rule applies on its effective date.
For the Kansas City market, the two sides of State Line Road differ: Kansas is an Agreement State, while Missouri facilities are licensed by the NRC.
What technologists should watch
- Whether the final rule keeps any pre-administration verification for diagnostic I-131.
- How your department words the physician definition in AU policy.
- Whether ALARA remains in your radiation safety program after the companion rule.
- Any NRC guidance, FAQs, or correction notices issued after publication.
Sources and method
Facts, figures, and quotations come from the primary documents below. Likelihood ratings, the placement of safeguards in the responsibility diagram, the eligibility readings, and the readiness questions are the author’s analysis.
- American Society of Radiologic Technologists. Comment letter on Docket ID NRC-2025-1237, “Reducing Barriers to Medical Use Licensing.” September 10, 2026. regulations.gov docket
- U.S. Nuclear Regulatory Commission. “Reducing Barriers to Medical Use Licensing.” Proposed rule, 91 FR 47042, July 27, 2026. Federal Register
- U.S. Nuclear Regulatory Commission. “Reforming and Modernizing the NRC’s Radiation Protection Framework.” Proposed rule, 91 FR 43456, July 15, 2026. Federal Register
- U.S. Nuclear Regulatory Commission. “Modernizing NRC Regulations for Byproduct Material Use.” Proposed rule, May 18, 2026. Federal Register
- Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission.” May 23, 2025. govinfo.gov
- 10 CFR Part 35, “Medical Use of Byproduct Material.” eCFR
- Minnesota Department of Health, Radioactive Materials Unit. Information Notice 2007-08, “Violations of written directives for use of I-131.” August 14, 2007. health.mn.gov
- American College of Radiology. “NRC Proposes Major Changes to Medical Use Regulations.” July 23, 2026. acr.org
- McGuireWoods. “NRC Proposed Rule Eases Regulatory Burden on Radiopharmaceutical Licensees.” May 2026. mcguirewoods.com
- Holland & Knight. “NRC Proposes Overhaul of Radiation Protection Framework.” July 2026. hklaw.com
- ASNT Materials Evaluation. “NRC Moves to Replace ALARA in Radiation Protection Overhaul.” August 2026. asnt.org
This page describes a proposed rule. The final rule may differ, and Agreement States adopt changes on their own schedules. Nothing here is legal advice. Content current as of September 26, 2026.