[Intl_DxMedPhys] NRC rule changes

[troyxzhou at icloud.com]

Thank you, Adam, and all who commented.

PHAROS, the AI compliance agent, and I took the liberty of summarizing the most important changes relevant to RSOs and medical physicists in the table below. The intent was to provide a concise side-by-side view of the current framework, the proposed changes, and the practical implications for RSO and medical physics review.

The main takeaway is that several of the proposals appear to reduce prescriptive licensing and documentation steps, but they also shift more responsibility to the licensee for internal controls, technical justification, and audit-ready recordkeeping. Please feel free to use this as a discussion aid for internal review or for drafting comments.

Troy Zhou, PhD, DABR, DABSNM
Managing Partner
Diagnostic Radiation Physics Services
(650) 683-0918
troy.zhou at diagnosticradphys.com

NRC Proposed Regulatory Changes — Practice Impact Crosswalk
Five NRC proposed rules issued April–July 2026 under Executive Order 14300. Comment deadlines: Part 37 security closed May 11, 2026; Byproduct Material Use closed July 2, 2026; Materials Licensing August 10, 2026; Radiation Protection Framework August 31, 2026; Reducing Barriers to Medical Use Licensing September 10, 2026. Note that the Radiation Protection Framework rule and the Medical Use rule both amend 10 CFR Part 35, on separate dockets.

Topic	Relevant 10 CFR sections	Current practice	Proposed change	Action needed
Radiation protection basis	§§20.1003 and 20.1101(b)–(d)	Radiation protection programs are structured around explicit ALARA language as a core management principle for exposures below regulatory limits.	Remove the ALARA definition and regulatory references. Revised §20.1101(b) would require procedures, engineering controls, and a graded approach to dose management based on sound radiation-protection principles.	Review the radiation safety manual, ALARA policy, committee charter language, and investigation triggers; draft replacement terminology and threshold-based decision criteria for future use.
Occupational dose management	§20.1201; proposed §20.1205; §§20.1206, 20.2104 and 20.2105	Worker-dose control relies on annual occupational limits and the existing planned special exposure framework under §20.1206.	Proposed §20.1205 would create a planned occupational dose-limit extension using available dose from the current and preceding four years, subject to annual and five-year constraints.	Determine whether dosimetry databases and approval forms could support five-year dose histories, written preauthorization, worker notification, cumulative calculations, and extension records.
Worker monitoring thresholds	§§20.1502 and 20.2106(a)(7)	Individuals meeting the criteria in §20.1502 must be monitored, with numerical results maintained under §20.2106.	Proposed §20.2106(a)(7) would allow an annotation instead of a numerical value when monitoring was required but the dose did not exceed 10% of the applicable monitoring criterion — 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.”	Review badge-assignment criteria, internal investigation levels, dose-record forms, and dosimetry-system interfaces.
Public dose control	§§20.1301 and 20.1302	Public-dose compliance is demonstrated through surveys, shielding assumptions, occupancy factors, area monitoring, and adjacent-area assessments. Current §20.1301 includes annual and short-term public-dose criteria.	Revise §20.1301 to remove the 2-mrem-in-one-hour criterion, establish caregiver provisions, and allow case-specific variances from certain public-dose or accessible-dose-rate limits with adequate controls. The annual public limit itself remains 0.1 rem (1 mSv) per year.	Review shielding evaluations, area-monitor placement, occupancy assumptions, public-dose worksheets, and procedures for evaluating unusual short-duration exposures.
Caregiver and patient-release framework	§20.1301(c); §20.2107(c)–(d); §§35.2, 35.75 and 35.2075	Under §35.75, a patient may be released when the dose to another individual is unlikely to exceed 0.5 rem from the release. Caregivers of patients who cannot be released may require an exemption to exceed the ordinary public-dose limit.	Proposed §35.75 would allow an informed and consenting caregiver to receive up to 5 rem following release per administration regimen. Other members of the public would remain limited to 0.5 rem per regimen. Proposed §20.1301(c) would separately allow up to 2 rem to a caregiver while caring for a patient who cannot be released, with a 0.5-rem limit for a non-caregiver visitor. The 5-rem and 2-rem figures apply to different situations — do not merge them.	Update patient-release calculations, caregiver designation and consent, written instructions, occupancy assumptions, cumulative regimen calculations, and pre-release caregiver-dose justification records.
Documentation and recordkeeping	Part 20, Subpart L, §§20.2101–20.2110; §§35.2059, 35.2060, 35.2075, 35.2080 and 35.2093	Records are maintained under existing Part 20 and Part 35 requirements and applicable license conditions.	The proposals would add or revise records for continuing education, planned dose extensions, patient release, caregiver exposure, Rb-82 systems, mobile services, and other performance-based determinations.	Review forms, logs, credentialing packages, dose-assessment memoranda, release records, and audit trails to ensure that each regulatory decision has a documented technical basis.
Authorized User additions	§§35.13(b), 35.24(g)(5), 35.100, 35.190, 35.200 and 35.290	Adding an Authorized User generally requires the licensing actions specified by §35.13.	Revised §35.13(b) would remove the amendment requirement for AUs limited to non-written-directive diagnostic uses under §§35.100 and 35.200. Qualification requirements under §§35.190 and 35.290 would remain. New §35.24(g)(5) would require the licensee to give the RSO authority to verify that those requirements are met before authorizing use.	Establish an internal AU approval process containing qualification verification, training records, preceptor attestations, RSO approval signatures, authorized-use scope, and inspection-ready documentation.
Training and experience pathways	§§35.50, 35.51, 35.55, 35.57–35.59, 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.490, 35.590, 35.690 and proposed 35.790	Part 35 contains prescriptive training, experience, recentness, board-certification, work-experience, and preceptor-attestation pathways for RSOs, AMPs, ANPs, and AUs.	Revise selected residency pathways, training hours, cases, board-recognition provisions, and generator experience. Section 35.59 would be retitled “Continuing education.” The seven-year window is not removed — it survives in §35.59(a)(1), (b)(1), and (c) (the last covering RSOs, ARSOs, AMPs, and ANPs). What is removed is the requirement to demonstrate it at the time of application; the obligation becomes continuous and per-use, with records under proposed §35.2059.	Crosswalk existing physician, AMP, ANP, and RSO files against the proposed pathways. Identify where competency, equivalency, continuing-education, or device-specific training documentation would be required. Do not retire seven-year tracking — re-scope it from an application gate to a continuing per-use check.
Emerging medical technologies	Y-90/microsources: §§35.40, 35.41 and proposed §§35.700, 35.710, 35.790 and 35.2710.

Rb-82: §§35.60, 35.63, 35.93, 35.204, 35.2060, 35.2093 and 35.3093.

Other EMTs: §§35.590–35.690 and 35.1000.	Technologies not fitting established Part 35 subparts are commonly licensed under §35.1000 using technology-specific guidance and license conditions. Rb-82 generator operations currently depend partly on enforcement discretion (EGM 13-003).	Codify selected mature technologies, including microsources such as Y-90 microspheres, Rb-82 generators, certain GSR systems, ophthalmic sources, and other devices. Generator breakthrough is rebuilt: §35.204’s fixed limits removed, new §35.93 requires licensee-written limits and pre-use training, and new §35.3093 requires telephone notice to the NRC Operations Center and the distributor within 7 calendar days, plus a written report within 30 days.	Review written directives, administration procedures, device QC, Rb-82 breakthrough testing, infusion-system calibration, microsource accountability, training, surveys, and medical-event procedures. Rewrite generator breakthrough procedures — the fixed limits go away and each licensee sets its own.
Byproduct-material licensing structure	§§30.4, 30.35(g), Appendix B to Part 30, 31.13, proposed 31.16, 32.72 and 32.74; §70.25	Diagnostic, PET, generator, and radiopharmacy activities generally operate through existing specific-license and distribution pathways.	Proposed §31.16 would create a Standard General License for certain fixed-site diagnostic medical uses. Section 30.4 would broaden PET consortium eligibility; Appendix B to Part 30 financial-assurance values would be revised (conforming change at §70.25), while §30.35(g) picks up a recordkeeping cross-reference for standard general licensees; and §§32.72 and 32.74 would add microsource distribution pathways.	Determine whether each diagnostic site could qualify for the Standard General License, subject to NRC or Agreement State adoption. Review PET consortium structure, financial-assurance calculations, and microsource procurement and distribution arrangements.
Security for applicable high-activity material	91 FR 17893: §§37.23, 37.25, 37.43(c)(3), 37.45(d), 37.49, 37.51 and 37.53. 91 FR 38124 separately amends §§37.5 and 37.11. §37.55 existing, not amended.

Source rule: 91 FR 17893, Docket NRC-2025-1238 — comments closed May 11, 2026	Facilities possessing Category 1 or Category 2 quantities follow prescriptive Part 37 access-authorization, training, coordination, monitoring, maintenance, and testing requirements.	Remove the ten-year reinvestigation in §37.25(c); change security refresher training (§37.43(c)(3)) and law-enforcement coordination (§37.45(d)) from not-to-exceed 12 months to at least every 3 years; remove Category 2 weekly verification and the security communications capability requirement (§37.49(a)(3)(ii) and (c)); remove and reserve §37.51, with §37.43(c)(3)(iv) amended (the codified text retains (iv) and the compatibility table says “Amend,” contradicting the preamble); and permit reliance on vehicle key removal under §37.53(b).	Map the existing security plan against each affected section. Do not eliminate current controls unless and until the final rule and applicable Agreement State regulations become effective. The rule estimates ~960 affected licensees and names, among them, “medical facilities using stereotactic radiosurgery devices; self-shielded irradiator users (such as those operating blood irradiators); teletherapy unit operators.” Programs that do not think of themselves as security licensees are in scope.
Audit readiness	§20.1101(c); §37.55 for applicable Category 1/2 programs; applicable license conditions	Radiation-protection program reviews and internal audits commonly emphasize records, postings, surveys, training, inventory, and completion of required forms.	A more performance-based framework would place greater weight on the documented technical basis for licensee decisions. Section 20.1101(c) would continue to require periodic review of the radiation-protection program.	Expand audits to evaluate the technical basis for dose thresholds, shielding, public-dose assessments, patient release, caregiver calculations, AU credentialing, security controls, and corrective actions.
Status: These are proposed federal changes. Current regulations and license conditions remain controlling until a final rule becomes effective and, where applicable, the Agreement State adopts compatible regulations.



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