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Lecture 5
Intro to regulation of RAM
| Question | Answer |
|---|---|
| Radiation protection is managed through what 3 entities? | Established regulatory bodies Scientific advisory bodies Users of the technology |
| Scientific Advisory Bodies | -Cannot issue or enforce regulation -Can make recommendations that often serve as the basis for radiation protection regulations |
| ICRP | International Commission on Radiological Protection Scientific Advisory Body |
| NCRP | National Council on Radiation Protection and Measurements Scientific Advisory Body |
| Regulatory Bodies | Have the authority to issue and enforce rules and regulations |
| NRC | Nuclear Regulatory Commission Regulatory body Protects public health and safety Protects environment from effects of radiation from nuclear reactors, materials, and facilities Promotes common defense and security |
| DOT | Department of Transportation Regulatory body |
| EPA | Environmental Protection Agency Regulatory body |
| FDA | Federal Drug Administration Regulatory bodies |
| TJC | The Joint Commission Additional Agency |
| USP | United States Pharmacopeia Additional agency |
| Additional Agency | Provide standards but do not enforce rules of regulations |
| AEC | Atomic Energy Commission Encouraged the use of nuclear power Responsibility of nuclear regulation |
| NRC Regulatory Process | Rulemaking, Guidance development, Licensing, Inspection, Investigation, Enforcement |
| Rulemaking | Developing and amending regulations that licensees must meet to obtain or retain license to use nuclear materials or operate a nuclear facility. |
| Guidance Development | Developing and revising guidance documents, like regulatory guides, standard review plans, and NRC inspection Manuals, to aid licensees in meeting safety requirements |
| Licensing | Authorizing an application to use or transport nuclear materials to operate a nuclear facility |
| Inspection | Verifying that a licensee's activity are properly conducted to ensure safe operations in accordance with NRC's regulations |
| Enforcement | Issuing sanctions to licensees who violate NRC regulations |
| CFR | The Code of Federal Regulations The governing legislation set forth by the NRC |
| 10 CFR 20 | Establishes standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the NRC Controls the receipt, possession, use, transfer, and disposal of licensed materials |
| 10 CFR 35 | Contains requirements and provisions for the medical use of byproduct material Provide the radiation safety of workers, general public, patients, human research subjects |
| 10 CFR 19 | Establish requirements for notices, instructions, reports by licensees and regulated entities Establish rights and responsibilities of Commission and indiduals during interviews via subpoena |
| Workers Rights | May have individuals represent them during inspection May consult privately with workers allowing worker to notify inspector of issues May request regulating bodies to perform inspection on facility |
| 10 CFR 71 | Establishes requirements for packaging, preparation for shipment, and transportation of licensed material |
| NUREG-1556 | Series of publications providing consolidated guidance about material licenses |
| Agreement state | The NRC may relinquish portions of its regulatory authority to license and regulate byproduct materials to the Stated |
| State Agencies | The regulations in agreement states must be at least as atrict as those of the NRC |
| Licensee | A company, organization, institution, or other entity which the NRC or Agreement state has granted a license Licensees who possess or use radioactive materials are required to obtain a Specific Radioactive Material License |
| Limited Scope License | Issued for radioactive material use in Academic & research & development Requires license amendments w regulatory agencies to change limitations (Radionuclides, Chemical & physical forms, Possession limits, Proposed uses, RSO, Auth users, locations) |
| Broad Scope Specific Licenses | Authorize possession and use or radioactive materials Significant decision-making authority Changes to radiation safety program approved by RSO |
| Broad Scope License Type A (Requirements) | Establishment of RSC Qualified RSO Establishment of administrative controls |
| Broad Scope License Type B (Requirements) | RSO Criteria developed by licensee and approved by the NRC or agreement state RSO reviews and approves all uses and users under license Changes to type, form and quantity of radioactive materials approved by regulatory agency |
| Broad Scope License Type C (Requirements) | Licensee must establish administrative controls and provisions related to procurement of byproduct material Changes to type, form, quantity of radioactive materials approved by regulatory agency |
| General License | NRC/Agreement State provides license for use of byproduct material (radioactive material contained within shielded source) Device handled with no radiation safety |
| General License Devices (GLD) | Gas Chromatograph Unit Fixed Gauging device Static Eliminators Luminous Exit signs Calibration or Reference Standards Ice Detection Devices In Vitro Lab Kits |
| Licensing Process - New License | Submit application Demonstrate use of materials meet safety requirements as established in NRC |
| Licensing Process - Amendment | Amendments may include changed in users, material use, transfer of license Must be submitted by RSO |
| Licensing Process - Ren |
Created by:
thandiwew