Study guide
Federal Guidance Documents: NRC Regulatory Guides, NUREGs, EPA & FDA Guidance
ABMP Medical Health Physics Exam
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1 Radiation Detection Instrumentation
Ionization Chambers & Geiger-Mueller Counters Scintillation Detectors, Photomultipliers & Gamma Spectroscopy Liquid Scintillation & Gamma Counting Systems: Well Counters & Thyroid Probes Personnel Dosimeters & Electronic Radiation Monitors Neutron Detection & Emergency Field Instrumentation
2 Laboratory Design & Contamination Control
Radiopharmaceutical Laboratory Design & USP <825> Standards Ventilation Systems, Fume Hoods & Contamination Engineering
3 Radiation Protection Standards & Dose Limits
Federal Regulatory Framework & Advisory Authorities Federal Guidance Documents: NRC Regulatory Guides, NUREGs, EPA & FDA Guidance Occupational & Public Dose Limits and ALARA Principles Radiobiological Basis of Limits & Risk Communication
4 Medical Licensing, Written Directives & Security
NRC Form 313 Authorizations, RSO Responsibilities & Written Directives Medical Event Reporting & 10 CFR 37 Category 1/2 Source Security
5 Diagnostic Radiology Structural Shielding
Diagnostic Shielding Methodology: NCRP Report 147 Modality Shielding: Radiography, Fluoroscopy & CT Facilities
6 Megavoltage Therapy Vault & Facility Shielding
Megavoltage Vault Primary & Secondary Barriers: NCRP Report 151 Therapy Maze Design, Photoneutrons & Shielded Doors PET/CT & Nuclear Medicine Facility Shielding (AAPM TG-108)
7 Radiation Oncology Quality Management & Safety
External Beam QA & Dosimetry Calibration Protocols Brachytherapy Safety, Inventory Control & Leak Testing
8 Radiation Oncology Emergency Procedures & TPS QA
Treatment Planning System (TPS) QA & Patient Verification Radiation Oncology Emergency Procedures: HDR Stuck Sources & Linac Failures Medical Events, Incident Investigation & Joint Commission Requirements in Radiation Oncology
9 Diagnostic Imaging Safety & Fluoroscopy Management
Diagnostic X-ray & Fluoroscopy Safety Interventional Fluoroscopy Dose Management & NCRP Report 168
10 CT Optimization, MQSA & Diagnostic Accreditation
Computed Tomography Dosimetry & Protocol Optimization Mammography Quality Standards Act (MQSA) & Mammography Physics Diagnostic Imaging Quality Management, Accreditation & Regulatory Oversight
11 Nuclear Medicine Radiopharmacy & Unsealed Therapy
Radiopharmaceutical QC & Radionuclide Calibrators Unsealed Source Therapy: I-131 Protocols & Patient Release Criteria
12 Targeted Radionuclide Therapy, Decontamination & RAM Transport
Targeted Radionuclide Therapies: Lu-177, Ra-223, Y-90 & Radioimmunotherapy Contamination Surveys, Spill Response & Personnel Decontamination Radioactive Waste Disposal & US DOT Transport Regulations
13 Radiobiology & Radiation Risk Assessment
Cellular Radiobiology, DNA Damage & Dose-Response Models Prenatal Radiation Risks & Population Exposures
14 Non-Ionizing Radiation Safety: Lasers & MRI
Healthcare Laser Safety: ANSI Z136.1 & Z136.3 MRI Safety, Facility Design & Bioeffects
Federal Guidance Documents: NRC Regulatory Guides, NUREGs, EPA & FDA Guidance
Key Takeaways Explain This Topic AI
Regulations (10 CFR, 21 CFR, 29 CFR, 49 CFR) are binding; NRC regulatory guides and NUREGs describe methods the staff finds acceptable, and licensees may use other methods if they show a basis for compliance.
Key NRC medical guidance includes NUREG-1556 Vol. 9 (medical licenses), RG 8.39 (patient release), RG 8.20 (radioiodine bioassay), RG 8.13 (prenatal exposure instruction), and RG 8.40 (effective dose equivalent from external exposure).
EPA Federal Guidance Report 11 supplies the dose coefficients behind 10 CFR 20 Appendix B ALIs and DACs, FGR 13 gives cancer risk coefficients, and FGR 14 (2014) gives radiation protection guidance for diagnostic and interventional x-ray procedures.
The EPA Protective Action Guides recommend evacuation or sheltering at projected doses of 1–5 rem over 4 days and relocation at 2 rem in the first year; FDA potassium iodide thresholds range from 5 cGy projected thyroid dose for children to 500 cGy for adults over 40.
OSHA's 29 CFR 1910.1096 covers ionizing radiation sources not regulated by the NRC, with a basic whole-body limit of 1.25 rem per calendar quarter.
Last updated: October 2026
Federal Guidance Documents: NRC Regulatory Guides, NUREGs, EPA & FDA Guidance
A medical health physicist works from two kinds of federal documents. Regulations in the Code of Federal Regulations are binding law. Guidance explains how an agency interprets its regulations, offers acceptable methods, and records technical bases. Examinations often ask which document a requirement or value comes from, and practice depends on knowing when guidance can be replaced by another approach.
Regulation versus Guidance
Type Examples Legal Status
Regulations 10 CFR 19, 20, 35, 37, 71; 21 CFR 900 and 1020; 29 CFR 1910.1096; 49 CFR 171–178 Binding; violations can bring enforcement
- NRC Regulatory Guides (RGs) RG 8.13, 8.20, 8.39, 8.40 Methods the NRC staff finds acceptable; not required
- NUREG reports NUREG-1556 Vol. 9 (medical use licenses) Licensing guidance and model procedures
- License conditions Commitments in an approved application Binding on that licensee once incorporated
EPA Federal Guidance Federal Guidance Reports, presidential guidance, PAG Manual Guidance to federal agencies; technical basis for rules
Regulatory Guide 8.20 states the principle directly: regulatory guides are not substitutes for regulations and compliance with them is not required, and methods that differ from them will be accepted if they provide a basis for the findings the NRC must make. A key subtlety is that a model procedure from a guide becomes binding when the licensee commits to it in its license application.
NRC Guidance for Medical Licensees
NUREG-1556, Volume 9, Revision 3 (2019) , Program-Specific Guidance About Medical Use Licenses : the licensing roadmap for 10 CFR 35, with model procedures for area surveys, spills (including Table N-1 major-spill amounts), leak tests, and training.
RG 8.39, Revision 1 : release of patients administered radioactive material, with default release tables, dose equations, and breast-feeding guidance.
RG 8.20, Revision 2 : applications of bioassay for radioiodine, with handling thresholds and action levels of 1 µCi and 5 µCi in the thyroid.
RG 8.13 : instruction concerning prenatal radiation exposure, describing the declared pregnant worker provisions of 10 CFR 20.1208.
RG 8.40 : methods for estimating effective dose equivalent from external exposure, including the two-dosimeter formulas used for workers wearing lead aprons.
RG 8.29 (risks from occupational radiation exposure) and RG 8.7 (recording and reporting occupational dose) support worker instruction and records.
EPA Federal Guidance
The EPA issues guidance to federal agencies on radiation protection:
Presidential guidance on occupational exposure (1987) set the federal framework, including the 50 mSv (5 rem) annual effective dose limit adopted in 10 CFR 20.
Federal Guidance Report No. 11 (1988) provides inhalation and ingestion dose coefficients that underlie the ALIs and DACs in 10 CFR 20 Appendix B.
FGR 12 gives external dose coefficients for radionuclides in air, water, and soil; FGR 13 gives cancer risk coefficients per unit intake or exposure.
FGR 14 (2014) , Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures , gives recommendations to federal facilities on justification, optimization, diagnostic reference levels, and qualified personnel, and is widely used as a model elsewhere.
Protective Action Guides (PAG) Manual (2017) : in the early phase of a radiological incident, evacuation or sheltering is recommended at projected doses of 1 to 5 rem (10–50 mSv) over 4 days , and relocation at 2 rem (20 mSv) projected in the first year , with a goal of 0.5 rem per year in later years.
FDA, OSHA, and Other Federal Guidance
FDA potassium iodide guidance (2001) : KI is recommended at projected thyroid doses of 5 cGy or more for children, adolescents, and pregnant or breast-feeding women , 10 cGy or more for adults 18–40 , and 500 cGy or more for adults over 40 .
FDA public health advisory (1994) on avoiding serious x-ray-induced skin injuries during fluoroscopically guided procedures, an early milestone that preceded the 2006 FDA requirement for air kerma displays on new fluoroscopes.
OSHA, 29 CFR 1910.1096 : applies to ionizing radiation sources not regulated by the NRC or an Agreement State in workplaces under OSHA jurisdiction. Its basic limits are per calendar quarter: 1.25 rem whole body , 18.75 rem to the hands and forearms or feet and ankles, and 7.5 rem to the skin of the whole body, with an allowance of 3 rem per quarter if lifetime dose stays within 5(N − 18) rem.
Using Guidance in Practice
When an inspector, accreditation surveyor, or examination question cites a value, the physicist should ask: Is it a regulatory limit, a license commitment, or a guidance value? For example, 5 mSv to the embryo/fetus is a regulation (10 CFR 20.1208), 0.5 mSv per month is an NCRP recommendation, the 33 mCi I-131 release table value is RG 8.39 guidance, and a facility's wipe-test action level is a license commitment or internal policy.