If your practice touches nuclear medicine or radiopharmaceutical therapy, there is a person on your licence called the authorized user. They are the reason your licence exists. Everything downstream — who may hold the vial, who signs the written directive, what your R S O actually supervises — hangs off how somebody becomes one.
On July 27 the Nuclear Regulatory Commission proposed to change that. The rule is called Reducing Barriers to Medical Use Licensing, it rewrites 10 CFR Part 35, and it runs from page 47042 to page 47100 of the Federal Register. Comments close September 10.
The change itself is defensible and serious people will defend it. What I cannot get past is the paper trail the N R C printed in its own background section.
From 2015 to 2016, both the NRC staff and the Advisory Committee on the Medical Uses of Isotopes (ACMUI) independently reviewed the training and experience requirements for medical uses authorized under Sec. 35.300... In its March 2016 report, the ACMUI concluded that no changes to the 700-hour requirement were warranted at that time as they found no evidence that the requirement adversely affected patient access.
That is the agency’s medical advisory committee, reviewing the hours question on purpose, and finding nothing. Not “we lacked data.” No evidence of harm to access — which is the argument the hours rule has always had to answer.
The committee then did the responsible thing and set up a standing subcommittee to keep looking. It kept looking for six years. In 2020 the staff sent the Commission a rulemaking plan. And in January 2022 the Commission answered.
Reviewed and left alone. Formally maintained. Removed.
The middle step is the one to hold on to: on January 27, 2022 the Commission issued SRM-SECY-20-0005, “maintaining the existing training and experience requirements” and directing staff to keep gathering input on emerging technologies. That is a decision, taken on a full record, four years after the review that found nothing wrong.
So what arrived between January 2022 and July 2026 to overturn a decision the Commission had just made on the merits?
The rule says. It is not a study, a registry, an access analysis or an adverse-event trend. It is an executive order.
At the time E.O. 14300 was issued on May 23, 2025, the NRC staff was actively evaluating training and experience requirements for Rb-82 generators and EMTs. The E.O. directed the NRC to undertake a comprehensive review and modernization of its regulations, including those governing the medical use of byproduct material. The proposed changes to training and experience in this rulemaking are in response to the E.O.
In response to the E.O. The agency is being straightforward, and I want to credit that rather than pretend I caught it hiding. Executive orders direct agencies; agencies comply; this is how the system is built to work. E.O. 14300 is titled “Ordering the Reform of the Nuclear Regulatory Commission” and it told the N R C to conduct a wholesale revision of its regulations.
But notice the shape of it. The question was studied for ten years by the people who understand it best and the answer kept coming back the same. The answer changed. The evidence did not. That is a thing worth being able to say out loud in a comment letter, and September 10 is when saying it stops counting.
Now the substance, because the substance is not a caricature and you should not post one.
Comments close September 10, 2026 on Docket NRC-2025-1237, and the N R C has put its draft implementing guidance out with the rule — which matters, because the guidance is where “sufficient experience in casework” either acquires a meaning or does not. If you supervise authorized users, the useful comment is not for or against. It is: what will a preceptor attestation say in practice, who bears the consequence when it turns out to have been generous, and what does a supervising A U need in the guidance to be able to refuse to sign one? An agency that has removed a number is unusually receptive, in the comment window, to being told what should replace it.
Kept honest. This is a proposed rule and nothing in it is in effect. It may be finalised changed, or not at all. The 700-hour requirement is not deleted from the regulations. It stops applying to physicians who completed a qualifying residency; the specialty-board and alternate pathways keep their specified hours for everyone else, and the N R C says residency-pathway physicians must still receive training and experience in all the required topic areas. Anyone posting “the N R C scrapped the 700 hours” will be wrong. The case-count change is broader than the hours change and I have stated them separately for that reason. “The evidence did not move” is my characterisation, and its basis is the rule’s own background section — which cites the 2016 ACMUI finding, the 2022 Commission decision and the E.O., and cites no new access study or safety analysis. I did not read every page of a fifty-nine-page rule or its draft guidance; if a new analysis is in there, I did not find it, and a commenter who has it should say so. I did not read the 2016 ACMUI report or SRM-SECY-20-0005 directly — both are quoted here as the N R C describes them in this rule, which is primary but one remove from the underlying documents. E.O. 14300 I have from this rule’s description of it, including its title and May 23, 2025 date; I did not fetch the order itself. And the argument in favour is real: I have given it its own paragraph above rather than burying it here, because a reader who only sees my objection is not being told the truth about this document.
Source, primary and fetched today, August 3, 2026. U.S. Nuclear Regulatory Commission, Reducing Barriers to Medical Use Licensing, proposed rule, 10 CFR Part 35, Docket No. NRC-2025-1237, RIN listed on the document, 91 FR 47042–47100, FR Doc. 2026-15080, published July 27, 2026 — full text (437,283 characters) read today via the Federal Register plain-text service, 2026-15080.txt, with document metadata from the Federal Register JSON API per house rules for WAF-blocked origins. Source of every quotation and every fact above, specifically: the abstract’s statement that the rule “responds to Executive Order 14300, ‘Ordering the Reform of the Nuclear Regulatory Commission,’ which requires the NRC to conduct a review and wholesale revision of its regulations” and would “reduce unnecessary burden in training and experience requirements for medical authorized users”; the comment close date of September 10, 2026; the 2015–2016 review passage and the March 2016 ACMUI conclusion, quoted in full above; the January 13, 2020 submission of SECY-20-0005 and the Commission’s January 27, 2022 SRM-SECY-20-0005 “maintaining the existing training and experience requirements”; the E.O. 14300 passage quoted in full above, including its May 23, 2025 issue date and the sentence “The proposed changes to training and experience in this rulemaking are in response to the E.O.”; the residency-pathway proposal to “remove the prescriptive requirements in Sec. Sec. 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, and 35.690 for specific numbers of classroom, laboratory, and work experience hours for physicians who have completed residency training in specialties where radiation safety and the clinical use of byproduct material are inherently integrated into the curriculum”, together with the “written attestation from a preceptor or residency program director” mechanism and the statement that the N R C “would retain the NRC-approved specialty board pathway and alternate pathway with specified hours for individuals who have not completed residency training in specialties identified in regulations”; the case-count provision that “Currently, Sec. Sec. 35.300, 35.392, 35.394, 35.396, and 35.491 require physicians to complete a prescribed number of cases to qualify as an AU” and that the rule “would replace the specified number of cases to qualify as an AU in the NRC’s regulations with a requirement that the physician receive sufficient experience in casework” documented by the supervising A U; the § 35.59 recentness-of-training changes, the seven-year threshold, the new § 35.2059 recordkeeping section and the statement that licensees “would no longer be required to submit documentation of recent training and experience with a license application”; and the provision permitting licensees to approve authorized users for certain non-therapeutic uses “without prior NRC review and approval.” The 2016 ACMUI report, SRM-SECY-20-0005 and E.O. 14300 are quoted as this rule describes them; I did not fetch those three documents separately. No trade press supplied any fact in this edition; I found no coverage of this rule.
The NRC spent ten years asking whether the 700-hour training rule for authorized users should change. In March 2016 its own medical advisory committee reviewed it and reported, in the agency's words, "no changes to the 700-hour requirement were warranted at that time as they found no evidence that the requirement adversely affected patient access." In January 2022 the Commission formally maintained the requirements. On July 27, 2026, the NRC proposed removing them. What changed in between is in the rule's own background section. It isn't a study. "At the time E.O. 14300 was issued on May 23, 2025, the NRC staff was actively evaluating training and experience requirements for Rb-82 generators and EMTs. The E.O. directed the NRC to undertake a comprehensive review and modernization of its regulations, including those governing the medical use of byproduct material. The proposed changes to training and experience in this rulemaking are in response to the E.O." In response to the E.O. The agency is being straightforward about it, and I'd rather credit that than pretend I caught it hiding something. Executive orders direct agencies. Agencies comply. That's the system working as designed. But look at the shape. The question was studied for a decade by the people who understand it best, and the answer kept coming back the same. Then the answer changed and the evidence didn't. What the rule actually does — and please don't post the caricature, you'll get corrected: The 700 hours are NOT deleted. A new residency-based pathway is added. A physician who completed a residency in a specialty where radiation safety and the clinical use of byproduct material are "inherently integrated into the curriculum" would no longer need the specified classroom, laboratory and work-experience hours across §§35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490 and 35.690. Instead: the residency, plus a written attestation from a preceptor or programme director. The specialty-board pathway and the alternate pathway keep their specified hours for everyone who didn't do such a residency. The case counts are different — that change applies to everyone. Today §§35.300, 35.392, 35.394, 35.396 and 35.491 require a prescribed number of cases. The proposal replaces the number with "sufficient experience in casework," evaluated and documented by the supervising authorized user. A count becomes a judgement. Whose judgement is the entire question. Two quieter changes in the same document: §35.59 — which today requires showing continuing education if your training was more than seven years ago — loses the prescriptive requirement in favour of a new internal recordkeeping section, and licensees "would no longer be required to submit documentation of recent training and experience with a license application." And for certain non-therapeutic uses, licensees could approve their own authorized users without prior NRC review, subject to inspection afterwards. Here's the fair case for it, because there is one. Radiopharmaceutical therapy is expanding faster than the framework built for it. Hour counts are a poor proxy for competence. A rule that keeps a qualified physician out of a community hospital has a patient cost too — just an invisible one. Performance-based regulation isn't a euphemism. The honest objection isn't "this is reckless." It's that the agency reached a conclusion its own record doesn't support, on a schedule it didn't choose. Comments close September 10 on Docket NRC-2025-1237, and the draft implementing guidance is out with the rule — which matters, because the guidance is where "sufficient experience in casework" either acquires a meaning or doesn't. If you supervise AUs, the comment worth writing isn't for or against. It's: what does a preceptor attestation have to say, who carries the consequence when one turns out to have been generous, and what does a supervising AU need in the guidance to be able to refuse to sign? An agency that has just removed a number is unusually receptive, during the comment window, to being told what should replace it. Kept honest: this is a proposal, nothing is in effect, and "the evidence didn't move" is my characterisation — its basis is that the rule's background section cites the 2016 finding, the 2022 decision and the executive order, and cites no new access or safety analysis. I didn't read all 59 pages or the draft guidance. If a new analysis is in there, I didn't find it, and whoever has it should say so in the docket.
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FIRST SOURCE · one verified original-source finding, composed for one reader · this edition: radiology and imaging — written for the people who have to decide what they are willing to put their name to