The 2026 NRC Rulemaking Wave: What Medical-Use Licensees Need to Know

Between April 9 and July 27, 2026, the NRC issued five proposed rules that together would rewrite the framework every medical-use licensee operates under — and two of them amend 10 CFR Part 35 at the same time, with comment deadlines ten days apart. ^{1, 2, 3, 4, 12}

If you read only the Part 35 rule, you will miss the fact that your patient-release procedure is being rewritten somewhere else. If you read only the Part 20 rule, you will miss that your authorized-user training pathways are being rebuilt. This article maps all five, separates what each one actually changes, and flags where the published commentary circulating among RSOs is right, and where it blends rules together.

Everything below describes proposed rules. Nothing here is in force. The operative documents are the Federal Register notices cited in the references; where this article summarizes, the citation points to the section you should read before acting.

Introduction

On May 23, 2025, Executive Order 14300, "Ordering the Reform of the Nuclear Regulatory Commission," was signed and later published at 90 FR 22587. Section 5, "Reforming and Modernizing the NRC's Regulations," requires the NRC to undertake a review and wholesale revision of its regulations and guidance documents. ^{1, 2, 5}

Section 5(b) is the provision that matters most to health physics. The Part 20 proposed rule quotes it directly: the NRC is to "reconsider reliance on the linear no-threshold (LNT) model for radiation exposure and the 'as low as reasonably achievable' standard, which is predicated on LNT," and "[i]n reconsidering those limits, the NRC shall specifically consider adopting determinate radiation limits." ¹

What came back is not a single rule. It is a coordinated set, each on its own docket, its own comment clock, and its own set of CFR parts. Five of them reach a medical-use licensee.

The four rulemakings at a glance

The two bolded Part 35 rules are the ones a medical-use licensee must read together, and the Part 37 rule is the one most likely to be missed entirely by a program that has Category 1 or 2 sources but does not think of itself as a "security" licensee. The Radiation Protection Framework rule runs 49 Federal Register pages; Reducing Barriers to Medical Use Licensing runs 59. Three new draft regulatory guides were issued with the Part 20 rule. ^{1, 2}

Two further proposed rules are in flight that touch medical licensees more indirectly and are not analyzed in depth here: Modernizing Package Certification Requirements (91 FR 46869, July 27, 2026, Docket NRC-2025-1667, 10 CFR Part 71, comments close August 26, 2026), which matters to anyone shipping or receiving radiopharmaceutical packages, and Integrated Low-Level Radioactive Waste Disposal (91 FR 40290, July 1, 2026, 10 CFR Parts 20, 61, 73, 150, comments close August 17, 2026). ^{13, 14}

The single most important structural fact: 10 CFR Part 35 is being amended by two separate proposed rules simultaneously. The Part 20 rule touches § 35.2, § 35.75, and § 35.2075. The Part 35 rule carries roughly eighty amendatory instructions but does not amend § 35.75 itself — though it does add a new § 35.76 governing patients who cannot be released under it. Neither notice reconciles the other's Part 35 changes into a single consolidated text. ^{1, 2}

Rule 3: the Radiation Protection Framework (Part 20 + patient release)

ALARA is proposed for removal as a regulatory term

The NRC states its conclusion plainly: "the appropriate approach would be to replace the ALARA principle with a requirement for a graded approach to dose management," and proposes "to remove all instances of the term ALARA from its regulations." ¹

This is not a proposal to stop reducing dose. The stated rationale is to return to the original intent of ALARA and to align with the ICRP concept of optimization. The mechanism, however, changes materially: "graded approach to dose management" becomes a defined term in § 20.1003, and § 20.1101(b) is amended to require it in place of ALARA. ¹

The commentary circulating among RSOs describing this as "ALARA 2.0, now with built-in cost-benefit analysis" is a fair characterization of what the notice proposes.

The cost-benefit test and its trigger levels

The graded approach is anchored to an explicit monetary value — but read carefully where that value lives. The notice describes guidance the NRC is developing and would issue after this rulemaking; the dollar figure is not in the codified rule text. That forthcoming guidance would point to NUREG-1530, Revision 1, "Reassessment of NRC's Dollar Per Person-Rem Conversion Factor Policy," under which "[t]he nominal cost of an averted person-rem under this standard is $5,200 (in 2014 dollars)." The notice then states that if a radiation protection measure "were more costly than that, the licensee would have an acceptable cost-justified basis" for not implementing it. ¹

The trigger levels below are likewise described in the notice as guidance the NRC would issue, not as codified regulatory thresholds. They key off existing regulatory values:

• 100 mrem/yr (1 mSv/yr) expected dose — triggers worker instruction under 10 CFR 19.12.
• 500 mrem/yr (5 mSv/yr) — 10 percent of the occupational limit; triggers individual monitoring under § 20.1502.
• 5 rem/yr (50 mSv/yr) — the occupational limit itself; the point at which the new § 20.1205 extension or the existing § 20.1206 planned special exposure would come into play.
• 25 mrem/yr (0.25 mSv/yr) for the public — 25 percent of the public limit; the notice describes "performing a cost-benefit analysis for projected public doses greater than or equal to 25 mrem/year." ¹

Separately, the air-emissions constraint in § 20.1101(d) would rise from 10 mrem/yr to 25 mrem (0.25 mSv) per year. ¹

Alternative dosimetry without case-by-case approval

Current Part 20 is built on the ICRP Publication 26 and 30 dosimetric system. The proposed rule adds a new § 20.1010 and a new Appendix H giving licensees "the option to voluntarily use specific, alternative, dosimetry methods, without requiring a separate, case-by-case NRC review and approval." ¹

One precision point worth holding onto, because it is easy to garble: the preapproved list in Appendix H is not "ICRP 60" or "ICRP 103" as such. Those publications are cited as the underlying scientific basis. What is actually listed for incorporation by reference are the derivative dose-coefficient documents — ANSI/ANS-6.1.1-2020 and ICRP Publications 56, 67, 68, 69, 71, 72, 116, 130, 134, 137, 141, 144, and 151. Any method not on that list "would still require case-by-case review and approval." ¹

New § 20.1004(e)(1) and (e)(2) make values determined by different dosimetry methods additive. Paragraph (e)(3) is the exception, not the permission: where a licensee uses weighting factors that differ from ICRP's for a given method, "the resulting quantities are not additive to values that are determined using International Commission on Radiological Protection methods," and additivity is then governed by the conditions in the corresponding NRC approval. ¹

Public dose: the limit stays, the hourly cap goes

The annual public dose limit in § 20.1301(a)(1) is unchanged at 0.1 rem (1 mSv) in a year. ¹

What changes is the rate limit. The NRC proposes "to delete Sec. 20.1301(a)(2) and the provision in Sec. 20.1302(b)(2)(ii) that references 2 mrem in an hour." The stated reasoning is that the annual limit is sufficient for public health and safety, and that licensees may voluntarily keep short-term dose-rate limits in their own radiation protection programs for dose management or investigation purposes. ¹

For diagnostic and nuclear medicine facilities, this is the single change most likely to alter a shielding design report. The 2 mrem-in-any-one-hour criterion is embedded in a great deal of existing barrier-design practice. Whether and how to change design practice if this becomes final is a professional judgment for the designer of record, not a regulatory default — the proposal removes a floor, it does not tell you what to design to.

Two further § 20.1301 changes: paragraph (b) adds a path to request a higher public dose limit within a controlled area, and the 500-mrem ceiling on case-by-case authorizations under paragraph (d) would be removed. ¹

Occupational limits hold, but a new extension appears

The numeric occupational limits are unchanged: 5 rem (0.05 Sv) TEDE, 50 rem (0.5 Sv) to an organ or tissue, 15 rem (0.15 Sv) lens of the eye, 50 rem (0.5 Sv) skin and extremity. ¹

The new mechanism is § 20.1205, a planned occupational dose limit extension. It allows an individual to exceed the annual limit against a budget of dose not used in prior years: "the dose allowed for a planned occupational dose limit extension as the occupational exposure that was unused by the individual over the most recent 5-year period." The worked example in the notice is 5 years at 5 rem TEDE, totaling 25 rem, minus actual TEDE received in the current and preceding four years. ¹

Three caps bound it, as codified in § 20.1205(d): "(1) Five times the numerical limits ... over the current year and the preceding four years; (2) Twice the numerical limits ... in any one year; and (3) A lens dose equivalent of 15 rem (0.15 Sv) in any one year." The lens limit is retained inside the extension rather than extended by it. Declared pregnant women and minors are excluded from the extension outright. ¹

Recordkeeping gets a small but practical change too. Amended § 20.2106(a)(7) would provide that where monitoring was required under § 20.1502 but the dose did not exceed 10 percent of the applicable monitoring criteria, the licensee "may, instead of recording the numerical value of the dose received, annotate that an occupational dose was received but did not exceed the criteria for recording." ¹

Section 20.2203 gains a matching five-year cumulative screen on two specific triggers: reporting of unplanned exceedances of the § 20.1201(a)(1)(i) TEDE limit is required "only if the total effective dose equivalent for the current year and the preceding four years exceeds 25 rem," and the public-limit trigger uses a five-year total "exceeds 500 mrem." The remaining § 20.2203 triggers are unchanged. ¹

Limits for the embryo/fetus (§ 20.1208) and for minors (§ 20.1207) are not amended by this rule.

Patient release is rewritten — in the Part 20 rule, not the Part 35 rule

This is the change most likely to be missed, because it lives in a rule whose title says "Radiation Protection Framework."

The rule adds two definitions to § 35.2. "Administration regimen" is "the course of administrations of a given radiopharmaceutical or brachytherapy source as intended by the authorized user." "Caregiver" is an adult providing support or comfort for non-commercial gain following administration. ¹

Section 35.75 is then revised and republished:

• Basis changes from per-release to per-administration-regimen. The notice states "the rule would be revised to specify that this limit is per administration regimen instead of per release." ¹
• The general-public limit is retained at 0.5 rem. "The dose limit to the general public would remain at 0.5 rem" — 5 mSv per administration regimen. ¹
• A new caregiver category is created at 5 rem. The rule would "allow a consenting caregiver, who has been educated on the risks of radiation exposure, to receive up to 5 rem (i.e., the occupation[al] dose limit of 10 CFR 20.1201) per patient administration regimen" — 50 mSv. ¹
• Written consent becomes a release condition. Proposed § 35.75(b)(1) conditions release on the licensee having "written consent from the released individual or, as necessary, the released individual's parent or guardian, and, if applicable, the released individual's caregiver." As drafted, that consent clause is not itself gated by a dose threshold; the caregiver-instruction clause beside it is. Read the codified paragraph yourself before designing a consent workflow — the scope of the consent requirement is exactly the kind of drafting detail worth a comment.
• Instructions under § 35.75(c) remain triggered where TEDE to another individual is likely to exceed 1 mSv, with breastfeeding-interruption guidance retained.
• Recordkeeping moves from per-release to program-level. Section 35.2075 would replace individual dose-evaluation records with a requirement to retain the written release procedure. ¹

In-patient visitors and caregivers get codified limits

Proposed § 20.1301(c) would let a licensee permit visitors to a patient who cannot be released to exceed the 0.1 rem public limit, provided the dose is not likely to exceed:

• 0.5 rem (5 mSv) for a member of the public who is not a caregiver, per administration regimen; or
• 2 rem (20 mSv) for a caregiver, per administration regimen,

and the authorized user "has determined before the visit that it is appropriate." ¹

The NRC frames this as removing the need "to apply for an exemption" — the historical route was a case-by-case exemption under the approach described in RIS 2006-18. Commentary describing the old route as a "license amendment" is close but not the term the NRC uses. A three-year retention requirement for caregiver-dose justification records is added. ¹

Draft guidance issued with this rule

The two rules take different guidance approaches. The Part 35 rule does not update NUREG-1556, Volume 9 concurrently — "the updates will be made in a future revision of the guidance." Instead it issues interim frequently-asked-questions guidance (ADAMS ML26167A223) that is in the docket and open for comment by the same methods as the rule, plus seven new NRC Form 313A variants (RSO, ANP, AMP, AUT, AUS, AUD, AUM). If you want to influence how the training changes are implemented, the FAQ document is the thing to comment on. ²

The Part 20 rule published three draft regulatory guides for comment: ¹

DG-8063 is the medical-institution guide among the three issued concurrently. Anyone redoing release calculations should also find DG-8061 (proposed RG 8.39, Revision 2), which the notice references for the release-dose assumptions: an occupancy factor of 0.25 at 1 meter for a general member of the public and 1 at 1 meter for a caregiver, with patient-specific calculations available for added flexibility. ¹ Note that the notice describes a two-phase approach: these three issue now, and further guidance — including the cost-benefit implementation guidance — follows after the rulemaking on a separate timeline. That means the rule's central new test would arrive before its guidance does.

Rule 4: Reducing Barriers to Medical Use Licensing (Part 35)

This rule carries roughly eighty amendatory instructions across Part 35. The highlights that change program operations:

Training and experience

• The definition of "physician" in § 35.2 would drop the specific MD/DO requirement, to admit foreign-trained physicians fully licensed to practice medicine in the United States. ²
• Named accrediting bodies are removed from §§ 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, and 35.690, in favor of required topic coverage. ²
• A residency-based pathway is added for §§ 35.190, 35.290, 35.390, 35.392, 35.394, and 35.396, removing prescriptive classroom/laboratory/work-experience hour counts for physicians completing residencies where radiation safety is integrated. The board-certification pathway and the alternate hours pathway are both retained. ²
• Fixed case counts become "sufficient experience in casework" in §§ 35.300, 35.392, 35.394, 35.396, and 35.491, evaluated and documented by the supervising authorized user. (The notice lists § 35.300 here, but states elsewhere that § 35.300 "would not be revised as part of this proposed rulemaking" and issues no amendatory instruction for it — a discrepancy worth a comment.) Experience shifts from "administering dosages" toward "preparing written directives and observing or performing the administration of dosages." ²
• § 35.59 would be retitled "Continuing education" — but seven years does not disappear. This is the item most often garbled. What the NRC removes is the requirement to demonstrate recent training and experience at the time of license application. The rewritten section keeps a seven-year window in § 35.59(a)(1) (uses requiring a written directive) and § 35.59(b)(1) (uses not requiring one), and § 35.59(c) retains the current seven-year test for RSOs, Associate RSOs, authorized medical physicists, and authorized nuclear pharmacists. The obligation becomes continuous and per-use rather than a one-time application showing, documented under new § 35.2059. ²
• New § 35.58 consolidates specialty-board approval currently scattered across eleven sections. ²
• Adding authorized users for § 35.100 and § 35.200 uses would no longer require a license amendment — diagnostic, non-written-directive uses could be approved internally, subject to inspection of the documentation. The pathway comes with a named owner: new § 35.24(g)(5) would require licensees to give the RSO authority to "Verify the training and experience of an individual meets Sec. 35.190 prior to authorizing use under Sec. 35.100 and 35.290 prior to authorizing use under Sec. 35.200." The RSO, not a license reviewer, becomes the gatekeeper. ²
• The low-dose/high-dose split for oral sodium iodide I-131 case experience (three cases each side of 1.22 GBq / 33 mCi) would be consolidated into a single category — for physicians seeking full § 35.390 authorization only. The limited-scope §§ 35.392 and 35.394 pathways, and their 1.22 GBq split, would remain available unchanged. ²
• § 35.50(c)(3) — redesignated § 35.50(b)(3) in the proposed text — would extend the simultaneous RSO/AU approval pathway to existing licenses and permits, not just new ones. Look up the redesignated number: in the proposed rule, § 35.50(c) is the specialty-board paragraph. ²

Emerging technologies brought into the standard subparts

• A new Subpart I for microsource brachytherapy (§§ 35.700, 35.710, 35.790) would move Y-90 microspheres out of § 35.1000 licensing. Note that § 35.790 explicitly retains "a minimum of three microsource cases" — the case count survives here even as it is removed elsewhere. New § 35.710(d) adds safety instructions for personnel caring for patients not releasable under § 35.75. ²
• Subpart F would change "strontium-90 sources" to "beta-emitting sources" throughout, covering devices such as the Sr-90 ophthalmic system and Y-90 disc products currently licensed under § 35.1000. Section 35.491 is retitled for "superficial ophthalmic use of beta-emitting sources." ²
• Gamma stereotactic radiosurgery and HDR requirements move from prescriptive to performance-based. Helmet-factor references come out of § 35.635; the prescriptive spot-check lists in § 35.645 and § 35.643(d)(1)–(8) are replaced by reliance on nationally recognized standards or NRC-accepted manufacturer instructions. Section 35.615 would remove the physical-door requirement while retaining the electronic interlock, and § 35.615's presence requirement is restructured for GSR units only so the AU may leave after treatment initiation, remaining immediately available, while the AMP remains physically present. Proposed § 35.615(e)(2) would require an AU and an AMP physically present at the initiation of all HDR treatments, and an AMP plus either an AU or a supervised trained physician present during continuation. The notice does not discuss this paragraph, so compare it against your current § 35.615(f)(2) before assuming HDR is unchanged. ²
• § 35.41(b)(4) would be broadened so the requirement to verify computer-generated dose calculations transfer correctly to the console applies to any modality, not only §§ 35.600 and 35.1000. This is the "computer-based treatment planning" item in circulating commentary. A separate new § 35.41(b)(6) would require written-directive procedures to address determining, within 60 calendar days of a permanent manual brachytherapy administration, the total source strength deposited outside the treatment site — unless patient unavailability is documented. ²
• Existing § 35.1000 authorized users would be grandfathered. New § 35.57(b)(4) provides that a physician authorized for a § 35.1000 use as of the effective date "need not comply with the training requirements for which the physician was authorized" under §§ 35.491, 35.690, or 35.790 — except the device- or microsource-specific training in each section's paragraph (c) for equipment they were not previously authorized to use. If your ophthalmic, GSR, or Y-90 microsphere AUs are wondering whether they re-qualify when their technology migrates into a standard subpart, this is the provision to read. ²

The generator breakthrough regime is rebuilt

This is the change most likely to reach a working hot lab, and it is easy to miss because it is spread across six amendatory instructions.

Section 35.204 — the fixed molybdenum-99, strontium-82, and strontium-85 breakthrough limits — would be removed, and replaced by a new § 35.93 relocated into Subpart C so it reaches therapeutic generators too. Under § 35.93 each licensee would write its own breakthrough limits and testing frequency, train every individual who elutes a generator before first use of a new or upgraded unit, and stop administering eluate exceeding its own established limits. Records move to new § 35.2093 (§ 35.2204 removed).

Reporting changes shape entirely. New § 35.3093 (replacing § 35.3204) would require telephone notification to the NRC Operations Center and the generator distributor within 7 calendar days of discovering an eluate over the permissible concentration, followed by a written report to the NRC Regional Office within 30 calendar days including the action taken, the patient dose assessment and its methodology, and the probable cause. ²

Relatedly, the § 35.290 work-experience list for diagnostic authorized users would drop generator elution, eluate purity testing, and reagent-kit processing — the NRC's position being that § 35.93 puts model-specific training on the people who actually elute rather than on every physician seeking § 35.200 authorization. ²

Written directives, mobile service, and research

• § 35.40 would be rewritten. An authorized user could revise the written directive during administration for brachytherapy other than HDR remote afterloading, provided the post-administration portion is signed and dated within 24 hours where the treatment site, total source strength, dose, or activity changed. The GSR written directive would newly specify dose per fraction and number of fractions — fractionated GSR is explicitly contemplated — and the permanent-brachytherapy paragraph extends to microsource brachytherapy. ²
• Mobile medical service requirements would be stripped to one obligation. Proposed § 35.80 would retain only the signed client-management letter. Deleted as duplicative of Part 20 and § 35.60: the pre-use instrument check at each client address, the survey-instrument check-source requirement, the survey of all areas of use before leaving the client's address, and the bar on delivering byproduct material to an unlicensed client. Associated survey records in § 35.2080(b) go with them. ²
• Human-subject research would no longer need a license amendment. Section 35.6 would be revised to drop the amendment requirement where the licensee is already authorized for the medical use, has IRB approval, and has obtained informed consent. ²
• Survey instrument calibration becomes energy-based. Section 35.61(a)(1) would require calibration "for the radiation type and energy range measured" rather than all scales up to 10 mSv (1000 mrem) per hour, and the two-readings-per-scale requirement would be removed. The conspicuous date-of-calibration notation survives, redesignated (a)(2). ²

Rubidium-82 and other operational changes

• EGM 13-003 would be codified. New § 35.63(d) and (e) would permit determining and recording each incremental dosage from a direct infusion system, for administrations meeting four criteria — including that the administered radioisotope "has a half-life of less than three minutes," no written directive required, direct administration from the generator without additional preparation, and adherence to manufacturer guidelines. New § 35.60(d) would require written procedures for testing infusion pump flow rate and radiation detectors; new § 35.60(e) sets the frequency at least every 12 months and following any repair that affects the calibration. ²
• Decay-in-storage would extend from 120 days to 275 days physical half-life in § 35.92, enabling DIS for Lu-177m and retention of Co-57 flood sources. ²
• The written directive for diagnostic sodium iodide I-131 above 1.11 MBq (30 µCi) would be eliminated and the use reclassified from Subpart E to Subpart D. ²
• Medical event reporting narrows. Events resulting from patient intervention or from a newly defined "emergent patient condition" that prevents completion of administration as planned would be excluded from § 35.3045(a), and reportable under § 35.3045(b) only where they result in unintended permanent functional damage to an organ or physiological system, as determined by a physician. A new § 35.3045(a)(3) adds reporting where a leak or defect in an administration device or supplies both delivers or results in a dose exceeding 0.5 Sv (50 rem) to an organ or tissue and differs from the written directive by 20 percent — both conditions, not either one. The NRC estimates the emergent-condition exclusion alone would reduce reporting "by approximately nine events per year"; that figure is not a net estimate across both changes. Section 35.3045(a)(2) would also extend the permanent-brachytherapy medical-event criteria to microsource brachytherapy while excluding microsources administered at the correct site but shunted elsewhere, where shunting was evaluated per the manufacturer's instructions beforehand ("shunting" becomes a defined term in § 35.2). Separately, new § 35.3047(a)(2) would exclude reporting an embryo/fetus dose above 50 mSv (5 rem) where "the licensee made a reasonable effort to determine pregnancy status but pregnancy could not be reasonably excluded prior to the administration." ²
• A new § 35.76 would consolidate the safety precautions for patients who cannot be released under § 35.75 out of the individual modality subparts into one section in Subpart C. It would let a licensee room such patients together "regardless of whether they received the same type of administration" — a Subpart E radiopharmaceutical patient with a Subpart I microsource patient, for example — and would replace the private-sanitary-facility requirement with shared access limited to similarly-administered patients within the controlled area. ²
• The Radiation Safety Committee requirement would narrow. Section 35.24(f) would be revised so an RSC "is only required if a licensee is authorized for two or more different types of uses or units that require written directives," clarifying that diagnostic uses do not trigger it. The mandatory nursing-service representative would also be removed. For a diagnostic-only or single-therapy licensee, this is the larger change of the two. ²
• Temporary RSO duration would extend from 60 to 120 days per calendar year. ²

The Part 37 security rule: the one most likely to be missed

If your program holds Category 1 or Category 2 quantities — a blood irradiator, a Co-60 teletherapy or gamma stereotactic unit, an HDR remote afterloader — this rule is about you, and its comment period has already closed. ¹²

Modernizing Requirements Relating to Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material (91 FR 17893, April 9, 2026, Docket NRC-2025-1238, RIN 3150-AL51) amends 10 CFR Part 37 only. Its summary places it in the same initiative as the others: the NRC "is conducting a review and wholesale revision of its regulations." Comments closed May 11, 2026. ¹²

The proposed reductions are specific:

• The 10-year reinvestigation would be removed. Section 37.25(c) currently requires reinvestigating every individual with unescorted access every 10 years. The NRC proposes removing it, stating the process "has not produced information leading to a licensee making a trustworthiness and reliability determination to revoke unescorted access." ¹²
• Refresher security training drops from annual to every three years. Section 37.43(c)(3) would go "from not to exceed 12 months to at least every 3 years, and when significant changes are made to the security program." ¹²
• Law-enforcement coordination drops from annual to every three years. Section 37.45(d) would change "from at least every 12 months to at least every 3 years, or when changes are made to the facility design or operation that adversely affect the potential vulnerability" of the material. ¹²
• Weekly verification of Category 2 material would be removed, along with the security communications capability requirement — § 37.49(a)(3)(ii) and (c). ¹²
• Section 37.51 would be removed and reserved, eliminating the maintenance and testing program, with a conforming removal of the associated training requirement in § 37.43(c)(3)(iv). ¹²
• Mobile devices: key removal becomes acceptable. Section 37.53(b) would be revised "to reflect advancements in vehicle ignition and disabling technologies by removing the prohibition on a licensee relying on key removal." ¹²

The operational caution here runs opposite to the rest of this package. These are reductions in security obligations, and a licensee that relaxes controls before a final rule takes effect — and, in an Agreement State, before the state adopts a compatible requirement — is out of compliance with the rules actually in force. The prudent read is to map the existing security plan against each affected section now, and change nothing until the final rule and the applicable state regulation are effective.

Rules 1 and 2: the licensing-side changes

Modernizing NRC Regulations for Byproduct Material Use (91 FR 28916) is the source of the general-license change that has drawn attention. It proposes a new class of general licenses called standard general licenses (SGLs) in a new 10 CFR Part 31, Subpart C, with technology-specific sections: § 31.14 certain fixed gauging, § 31.15 portable gauging, § 31.16 certain medical uses, § 31.17 certain analytical equipment, and § 31.18 certain in vitro testing. ³

Section 31.16 is the "general license for simple diagnostic nuclear medicine" referenced in circulating commentary. The SGL would be an alternative to a specific license, not a replacement — the notice states the specific-license pathway "would be preserved so as to not limit flexibility." Section 31.13 imposes registration (NRC Form 1003, filed at least 30 days in advance), a five-location cap, and inventory limits preventing aggregation into Part 37 quantities. Section 31.16(a)(2) carries an exhaustive radionuclide list and is proposed as Compatibility Category C, meaning Agreement States could authorize additional radionuclides. ³

Modernizing Materials Licensing (91 FR 38124, Docket NRC-2025-1370) is primarily a licensing-process and storage rule across Parts 30, 37, 40, 51, 70, 72, and 140, and is the least medical-specific of the four. ⁴

Where the circulating commentary is right, and where it blends rules

Much of what is being passed around RSO mailing lists is accurate. Three corrections are worth making before you repeat any of it:

The last row is the practical point. The two Part 35-amending rules are on different dockets with different deadlines. A comment on training filed to Docket NRC-2025-1140 is filed in the wrong place.

Practice impact crosswalk

The table below maps each topic to the sections involved, what changes, and what a licensee would actually have to look at. Every row describes a proposal; nothing here is in force.

Practical steps for licensees

1. Read both Part 35-amending rules together. Build a single working copy of Part 35 that overlays 91 FR 43456 (§§ 35.2, 35.75, 35.2075) onto 91 FR 47042 (everything else). Neither notice does this for you.
2. Calendar the live deadline. Comments on the Radiation Protection Framework rule close August 31, 2026; on Reducing Barriers to Medical Use Licensing, September 10, 2026. Confirm both on regulations.gov before relying on them — comment periods are extended more often than they are shortened.
3. Inventory what your current program hard-codes. Search your radiation protection program, shielding reports, release procedures, and training files for "ALARA," "2 mrem in any one hour," "per release," and "recentness of training." Those are the phrases most likely to require revision.
4. Map your patient-release workflow to "administration regimen." For any multi-fraction or multi-cycle therapy, determine now how many administrations constitute one regimen in your practice, and whether your current per-release calculation would change.
5. Decide whether you would use the optional provisions. The § 20.1205 dose-limit extension, the § 20.1010 alternative dosimetry option, the § 31.16 standard general license, and the internal AU approval for §§ 35.100/35.200 are all opt-in. None requires action if you do not want it.
6. Comment on what affects you. Both notices carry specific requests for comment. The Part 20 rule asks six numbered questions. Question 4 is the one aimed squarely at medical use: the advantages and disadvantages of a per-regimen basis for patient release, whether it would create barriers to treatment access, and whether the NRC should instead keep a per-administration basis for members of the public while applying a per-regimen basis for caregivers. Question 6 asks whether the public dose limit itself should be raised and on what basis. The Part 35 rule asks eight. For a multi-state practice the most consequential is Question 2, on whether § 35.11(b)'s compatibility category should move from C to B — Category C currently lets an Agreement State require an authorized user to be physically present during medical use, which the NRC says "raises transboundary concerns as medical networks have grown and many cross state lines." The others include whether the three-minute half-life threshold in § 35.63 is right, whether the decay-in-storage limit should exceed 275 days, whether the physician definition should add "fully licensed to practice medicine independently," and whether fellowship training should also qualify for removal of prescriptive hours.
7. Weigh the timing of any procedure revision. These are proposals; final rules commonly differ from proposals, and Agreement State adoption adds further delay. Any revision made now is anticipatory, and whether that is worth doing is a program-management call for each licensee.

Common pitfalls to avoid

• Assuming one rule covers Part 35. Two do, on separate dockets.
• Treating a proposed rule as effective. Nothing here is in force; both medical-relevant notices propose an effective date 30 days after publication of a final rule, and both ask commenters whether that is enough time to implement.
• Assuming the federal date is your date if you are in an Agreement State. Neither notice states a numeric adoption deadline for Agreement States.
• Treating the 2 mrem/hr criterion as already gone. It is proposed for deletion, not deleted, and the proposal supplies no replacement criterion.
• Repeating the "ICRP 60/103 is now preapproved" shorthand. The Appendix H list is specific, and non-listed methods still need approval.
• Filing a comment on the wrong docket. NRC-2025-1140 and NRC-2025-1237 are not interchangeable.
• Missing the Part 37 rule because you do not think of yourself as a security licensee. A single blood irradiator or a Co-60 unit can put a program in Category 1 or 2.
• Relaxing a security control early. The Part 37 reductions are proposals; the current requirements remain enforceable until a final rule is effective and, in an Agreement State, adopted.

Regulatory Considerations

All four notices assign Agreement State compatibility categories section by section. In the Part 20 rule, several new § 20.1003 definitions — including "graded approach to dose management" and "planned occupational dose limit extension" — plus § 20.1101(b), § 20.1101(d), and the new § 20.1205 are proposed as Category A. The new Part 35 "caregiver" and "administration regimen" definitions and revised § 35.75(b), along with § 20.1010 and Appendix H, are proposed as Category B. ¹

In the Part 35 rule, the NRC states it "is not proposing any changes to the current compatibility designations" for amended and redesignated requirements, with one exception: § 35.300 would revert from Category B to its original Category H&S designation from the 2002 rule (67 FR 20250). ²

Neither notice states a numeric Agreement State adoption deadline. For the states DRPS serves, Florida, Maryland, Virginia, California, Nevada, Pennsylvania, New York, and New Jersey are Agreement States administering compatible programs, while Washington, DC and Delaware are regulated directly by the NRC. Licensees should confirm timing with the authority that issued their license rather than assuming the federal schedule applies. For background on how reciprocity works across those boundaries, see our guide to NRC and Agreement State reciprocity.

The NRC projects cost savings of approximately $9.53 million per year to industry at a 7 percent discount rate from the Part 20 rule, and net savings of $39.1 million undiscounted over five years (2027–2031) from the Part 35 rule. Both figures are the NRC's own estimates as presented in the notices. ^{1, 2}

Frequently Asked Questions (FAQs)

What is Executive Order 14300 and why is the NRC issuing so many rules at once?

Executive Order 14300, "Ordering the Reform of the Nuclear Regulatory Commission," was signed May 23, 2025 and published at 90 FR 22587. Section 5 directs the NRC to undertake a review and wholesale revision of its regulations and guidance. Section 5(b) specifically directs the agency to reconsider reliance on the linear no-threshold model and the ALARA standard. The four proposed rules issued between May and July 2026 are the NRC's response.

Is ALARA being eliminated?

In the proposed Part 20 rule, yes — as a regulatory term. The NRC proposes to remove every instance of ALARA from its regulations and replace it with a defined "graded approach to dose management." The stated intent is to return to the original intent of ALARA and align with the ICRP concept of optimization, not to abandon dose reduction. This is a proposal, not a final rule.

What is the dollar-per-person-rem figure in the new graded approach?

The notice describes guidance the NRC is developing and would issue after this rulemaking — the figure is not in the codified rule text. That guidance would point to NUREG-1530, Revision 1, under which the nominal cost of an averted person-rem is $5,200 in 2014 dollars, as one example of a reasonable cost basis: a measure costing more than that would give a licensee a cost-justified basis for not implementing it, provided the dose stays within the regulatory limits.

How would patient release change under the proposed rules?

The Part 20 rule would rewrite 10 CFR 35.75. The 5 mSv (0.5 rem) limit to the general public would be retained but applied per administration regimen rather than per release. A new caregiver category would allow a consenting, educated caregiver to receive up to 50 mSv (5 rem) per administration regimen. Written consent from the released individual would be required.

How much dose could a caregiver receive for a patient who cannot be released?

Proposed 10 CFR 20.1301(c) would codify 5 mSv (0.5 rem) per administration regimen for a member of the public who is not a caregiver, and 20 mSv (2 rem) per administration regimen for a caregiver, without the licensee having to request an exemption. The authorized user must determine before the visit that it is appropriate.

When do comments close on these rules?

Comments on Modernizing NRC Regulations for Byproduct Material Use closed July 2, 2026. Comments on Modernizing Materials Licensing closed August 10, 2026. Comments on the Radiation Protection Framework rule close August 31, 2026, and comments on Reducing Barriers to Medical Use Licensing close September 10, 2026. Always confirm current dates on regulations.gov before relying on them.

Do Agreement States have to adopt these changes?

Agreement State medical-use and radiation-protection requirements must be compatible with the NRC's, and each rule assigns a compatibility category section by section. Several new Part 20 definitions and the new dose-limit-extension provision are proposed as Category A. Neither proposed rule states a numeric adoption deadline, so licensees in Agreement States should not assume the federal effective date is their effective date.

Key Takeaways

• Five proposed rules, not one. Issued April–July 2026 under Executive Order 14300, on five separate dockets with five separate comment clocks. Two have already closed.
• Two of them amend 10 CFR Part 35 at once. The Part 20 rule rewrites § 35.75 patient release; the Part 35 rule rewrites training, emerging technologies, and reporting. Read them together.
• ALARA would be replaced by a "graded approach to dose management." The cost-benefit anchor — $5,200 per averted person-rem — and the stepwise triggers at 100 mrem/yr, 500 mrem/yr, and 5 rem/yr occupational and 25 mrem/yr public are described as forthcoming guidance, not codified rule text.
• Dose limits mostly hold. Occupational 5 rem TEDE and public 0.1 rem/yr are unchanged. The 2 mrem-in-any-one-hour public rate limit would be deleted, and the air-emissions constraint would rise from 10 to 25 mrem/yr.
• Patient release moves to a per-administration-regimen basis, retains 0.5 rem to the general public, adds a 5 rem consenting-caregiver category, and requires written consent.
• In-patient caregivers get a codified 2 rem per administration regimen without an exemption request.
• The seven-year recentness rule does not "go." Section 35.59 is retitled "Continuing education"; the at-application demonstration is removed, but a seven-year window survives in § 35.59(a)(1), (b)(1), and (c), now as a continuous per-use obligation recorded under § 35.2059.
• Part 37 security requirements would be cut — the 10-year reinvestigation removed, refresher training and law-enforcement coordination moved from annual to every three years, Category 2 weekly verification removed, and § 37.51 reserved. That comment period closed May 11, 2026.
• Nothing is in force. These are proposals. The live deadlines are August 10, August 31, and September 10, 2026. Relaxing a control before a final rule — and before Agreement State adoption — is non-compliance with the rule actually in force.

Conclusion

The 2026 rulemaking wave is the largest coordinated revision of the NRC's radiation protection and medical-use framework since 1991 for Part 20 and 2002 for Part 35. For a medical-use licensee, the substance falls into three buckets: a philosophical change in how dose reduction is justified, a set of concrete numeric changes to patient release and visitor dose, and a broad loosening of prescriptive training and device requirements.

The near-term work is not procedure rewriting — it is reading. Build the consolidated Part 35 text that neither notice provides, identify which of your current requirements are proposed to change, decide which optional provisions you would actually use, and comment on the ones that would affect your program while the dockets are still open. Whether any given change is good for patient safety, for your program, or for the profession is a judgment for you to make and to put on the record; the deadlines are the part that is not negotiable.

How DRPS Can Help

Diagnostic Radiation Physics Services helps medical-use licensees assess what proposed regulatory changes would mean for an existing program — reconciling the two Part 35-amending rules into a single working text, identifying which current procedures, shielding assumptions, release calculations, and training records are affected, and supporting comment preparation. This work is part of our radioactive material license support, radiation safety officer, and medical physicist consulting services.

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

Related Resources

• Authorized user and medical physicist training and experience
• Patient release after radiopharmaceutical therapy
• NRC occupational dose limits under Part 20
• Public dose limits under Part 20
• Building an ALARA program
• Medical event reporting under 10 CFR 35.3045
• NRC and Agreement State reciprocity
• The NRC medical use license guide

References

1. U.S. Nuclear Regulatory Commission. Reforming and Modernizing the NRC's Radiation Protection Framework. Proposed Rule, 91 FR 43456 (July 15, 2026); Docket ID NRC-2025-1140; RIN 3150-AL47; comments close August 31, 2026. federalregister.gov
2. U.S. Nuclear Regulatory Commission. Reducing Barriers to Medical Use Licensing. Proposed Rule, 91 FR 47042 (July 27, 2026); Docket ID NRC-2025-1237; RIN 3150-AL50; comments close September 10, 2026. federalregister.gov
3. U.S. Nuclear Regulatory Commission. Modernizing NRC Regulations for Byproduct Material Use. Proposed Rule, 91 FR 28916 (May 18, 2026); Docket ID NRC-2025-1205; RIN 3150-AL49. federalregister.gov
4. U.S. Nuclear Regulatory Commission. Modernizing Materials Licensing. Proposed Rule, 91 FR 38124 (June 24, 2026); Docket ID NRC-2025-1370; RIN 3150-AL56. federalregister.gov
5. Executive Order 14300, Ordering the Reform of the Nuclear Regulatory Commission, 90 FR 22587 (signed May 23, 2025). federalregister.gov
6. U.S. Nuclear Regulatory Commission. NUREG-1530, Revision 1: Reassessment of NRC's Dollar Per Person-Rem Conversion Factor Policy. ADAMS ML22053A025. 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
9. U.S. Nuclear Regulatory Commission. Draft Regulatory Guide DG-8063 (proposed Revision 3 of Regulatory Guide 8.18), Information Relevant to Radiation Dose Management at Medical Institutions, July 9, 2026. ADAMS ML25294A723. nrc.gov
10. U.S. Nuclear Regulatory Commission. Wholesale Revision of Regulations Under Executive Order 14300. nrc.gov
11. Regulations.gov. Docket NRC-2025-1237 — Reducing Barriers to Medical Use Licensing. regulations.gov
12. U.S. Nuclear Regulatory Commission. Modernizing Requirements Relating to Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Proposed Rule, 91 FR 17893 (April 9, 2026); Docket ID NRC-2025-1238; RIN 3150-AL51; comments closed May 11, 2026. federalregister.gov
13. U.S. Nuclear Regulatory Commission. Modernizing Package Certification Requirements. Proposed Rule, 91 FR 46869 (July 27, 2026); Docket ID NRC-2025-1667; RIN 3150-AL62; comments close August 26, 2026. federalregister.gov
14. U.S. Nuclear Regulatory Commission. Integrated Low-Level Radioactive Waste Disposal. Proposed Rule, 91 FR 40290 (July 1, 2026); RIN 3150-AI92; comments close August 17, 2026. federalregister.gov