تصفح 18,548 لائحة من 36 جهة تنظيمية

Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations

Conventional Health and Safety

Radiation Protection, Version 1.1

Licence Application Guide: Nuclear Substances and Radiation Devices, Version 2.1

Personnel Certification: Radiation Safety Officers

Dosimetry, Volume I: Ascertaining Occupational Dose

Radiation Protection Guidelines for the Safe Handling of Decedents

Reporting Requirements for Waste Nuclear Substance Licensees, Class II Nuclear Facilities and Users of Prescribed Equipment, Nuclear Substances and Radiation Devices

Licenses and Radiation Safety Requirements for Well Logging

Licenses and Radiation Safety Requirements for Irradiators

Occupational Radiation Protection

10 CFR Part 835 establishes occupational radiation protection standards and limits for DOE activities to protect workers from ionizing radiation. The regulation defines scope, exclusions (NRC-licensed activities, naval reactors, medical uses, foreign territory operations), and requires compliance with occupational dose limits. Key concepts include accountable sealed sources, airborne radioactivity, and ALARA principles for minimizing radiation exposure.

Radiation Protection Programs for Nuclear Substances and Radiation Devices Licences

Standards for Protection Against Radiation

Application Guide: Certification of Radiation Devices or Class II Prescribed Equipment, Version 1.1

WA3 6GR, Sellafield Limited environmental permit variation advertisement – EPR/KP3690SX/V015

View the application submitted by Sellafield Limited for Sellafield Site, Cumbria.

Irradiation in the Production, Processing and Handling of Food

21 CFR Part 179 establishes safety standards for using ionizing radiation sources in food production, processing, and inspection. Approved sources include X-ray tubes (≤500 kVp), sealed isotope units (americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, strontium-90), californium-252 for moisture measurement, and machine sources up to 10 MeV. Facilities must comply with current good manufacturing practices, apply minimum effective doses not exceeding specified limits (10 grays for standard sources, 2 milligrays for californium-252), use scheduled processes, and ensure packaging compliance.

New Drugs

21 CFR Part 310 establishes regulatory definitions and interpretations for new drugs under the Federal Food, Drug, and Cosmetic Act. It defines key terms including new drug substances, sponsors, related drugs, special packaging requirements, and radioactive drugs. Newness may arise from new substances, new combinations, new proportions, new uses, or new dosages/administration methods.

Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research

Part 361 establishes conditions under which radioactive drugs are considered safe and effective for basic research use in human subjects. Research must be approved by a Radioactive Drug Research Committee and meet strict limits on pharmacological dose, radiation dose, and cumulative exposure. Studies must demonstrate qualified investigators, proper licensure, informed consent, institutional review, and adverse event reporting.

Diagnostic Radiopharmaceuticals

This regulation establishes FDA standards for diagnostic radiopharmaceuticals used in vivo for diagnostic and monitoring purposes. It defines diagnostic radiopharmaceuticals, outlines safety and effectiveness evaluation criteria including pharmacological/toxicological activity and absorbed radiation dose, categorizes proposed indications (structure delineation, functional assessment, disease detection, patient management), and specifies methods for demonstrating effectiveness through clinical evaluation against reliable diagnostic standards.

Radioactive substances regulation (RSR): objective and principles

UK guidance document outlining the fundamental objective of radioactive substances regulation and the 10 regulatory principles applied by the regulator in managing radioactive materials and associated activities.

Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under Section 274

This regulation defines exemptions and regulatory authority under Section 274 of the Atomic Energy Act for Agreement States and offshore waters. It establishes the scope of NRC oversight for byproduct material, source material, and special nuclear material in quantities insufficient to form critical mass, and clarifies that Agreement States have limited authority while the NRC retains jurisdiction over specified activities.

Performance Standards for Electronic Products: General

Performance standards for electronic products under 21 CFR Part 1010 establish certification and labeling requirements to control electronic product radiation. Manufacturers must certify conformance to applicable standards via permanently affixed labels or tags, with certification based on individual product testing or qualified manufacturing programs. The regulation covers general provisions for radiation control and includes specific provisions for laser products incorporating certified laser systems.

Performance Standards for Light-Emitting Products

FDA performance standards for laser products manufactured after August 1, 1976, establishing safety classifications (Class I, IIa, II, etc.) and accessible emission limits to protect human exposure to laser radiation. Manufacturers must register products, provide warning labels and safe installation instructions, and maintain distribution records.

Performance Standards for Microwave and Radio Frequency Emitting Products

This regulation establishes performance standards for microwave ovens manufactured after October 6, 1971, setting limits on microwave radiation emission and requiring safety interlocks. Microwave ovens must not exceed 1 milliwatt per square centimeter power density at 5+ centimeters from the external surface before purchase, and 5 milliwatts per square centimeter thereafter. Devices must have at least two operative safety interlocks designed to prevent microwave generation when cavity access is possible, with at least one interlock resistant to human body contact and magnetic manipulation.

Performance Standards for Ionizing Radiation Emitting Products

21 CFR Part 1020 establishes performance standards for ionizing radiation emitted by television receivers with cathode ray tubes manufactured after January 15, 1970. The regulation limits radiation exposure rates to 0.5 milliroentgens per hour at 5 centimeters from the external surface, with measurement requirements and testing conditions specified for user controls, service controls, and component failure scenarios. Manufacturers must affix warning labels on receivers exceeding exposure limits.

Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food

21 CFR Part 579 establishes safety standards for using ionizing radiation in animal feed and pet food production. Facilities may use gamma rays (cobalt-60, cesium-137) or electrons (up to 10 MeV) to treat complete animal diets and ingredients. For poultry feed, additional X-ray sources are permitted. Minimum effective dose for salmonella control is 2.0 kGy; maximum is 25 kGy. Facilities must comply with Part 507 and incorporate applicable Part 179 food irradiation regulations.

General

21 CFR Part 1000 establishes general provisions and definitions for the regulation of electronic products that emit radiation under the Federal Food, Drug, and Cosmetic Act. Key terms include electronic product radiation (ionizing or nonionizing electromagnetic or particulate radiation, or sonic/ultrasonic waves), electronic products (manufactured items containing electronic circuits that emit such radiation), and related industry roles such as manufacturers, distributors, and dealers. The regulation provides foundational definitions for chassis families, component classifications, and model designations used in subsequent radiation safety standards.

Notification of Defects or Failure to Comply

21 CFR Part 1003 establishes notification requirements for manufacturers of electronic products regarding defects or non-compliance with Federal standards, particularly those involving unintended or excessive electronic product radiation emissions that pose injury risk. Manufacturers must immediately notify the Secretary and relevant dealers, distributors, and purchasers upon discovery of defects or compliance failures in products manufactured after October 1968.

Records and Reports

21 CFR Part 1002 establishes record-keeping and reporting requirements for manufacturers, dealers, and distributors of electronic products, particularly radiation-emitting devices. Manufacturers must submit performance data, technical safety information, and test data to the FDA's Center for Devices and Radiological Health. Exemptions apply to products solely for export, components sold to other manufacturers, U.S. Government products with national security restrictions, and certain diagnostic x-ray equipment assemblers. Trade secret information is kept confidential.

Environmental permitting: waste, installations and radioactive substances activity notices of applications made

UK Environment Agency notices listing environmental permitting applications submitted for waste management, industrial installations, and radioactive substances activities.