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Showing 1–21 of 21 regulations
Worker Safety and Health Program
10 CFR Part 851 establishes mandatory worker safety and health program requirements for contractors at Department of Energy sites. The rule requires safe and healthful workplaces, procedures for investigating violations, and appropriate remedies. It excludes work regulated by OSHA, naval nuclear propulsion operations, radiological hazards covered by other CFR parts, and transportation to/from DOE sites.
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.
Notices, Instructions and Reports to Workers: Inspection and Investigations
10 CFR Part 19 establishes requirements for NRC licensees and regulated entities to provide notices, instructions, and reports to workers in nuclear-licensed activities. It defines worker rights and responsibilities during NRC inspections and investigations, including rules for compelled interviews under subpoena, and applies to all persons involved in NRC-licensed nuclear material, production/utilization facilities, and spent fuel storage installations.
Human Space Flight Requirements
14 CFR Part 460 establishes crew qualification and training requirements for human spaceflight operations under FAA licensing and permitting. Crew members must complete training on their assigned roles in nominal and emergency conditions, demonstrate ability to withstand space flight stresses, and maintain current medical certificates. Pilots and remote operators must hold FAA pilot certificates with instrument ratings and receive vehicle-specific training through simulation, comparable aircraft, flight testing, or equivalent methods approved by the FAA. Operators must maintain training records, document lessons learned, and ensure recurrent training schedules keep all crew qualifications current before launch and reentry.
Care and Use of Animals in the Conduct of NASA Activities
NASA regulation 14 CFR Part 1232 establishes policies for the care and use of vertebrate animals in NASA activities, including those conducted at NASA facilities, spacecraft, and through contracts with external entities. The regulation requires compliance with the Animal Welfare Act of 1966 and implements minimum standards of care and treatment for animals used in NASA research, testing, teaching, and hardware development.
Security Programs; Arrest Authority and Use of Force by NASA Security Force Personnel
This regulation establishes guidelines for NASA and NASA contractor security force personnel authorized to exercise arrest authority and use physical force, including deadly force. Personnel must complete accredited training and receive written certification before exercising arrest authority on NASA facilities. The regulation defines conditions for warrantless arrests, protocols for announcing authority, searching arrestees, and transferring custody to appropriate law enforcement, with restrictions on the use of non-deadly physical force limited to what is reasonable and necessary.
Nondiscrimination on Basis of Disability
14 CFR Part 1251 implements Section 504 of the Rehabilitation Act of 1973 to eliminate discrimination based on disability in programs receiving Federal financial assistance from NASA. The regulation defines disability broadly and establishes requirements for recipients to provide auxiliary aids and services, ensure accessibility per ADA Standards, and avoid discrimination in employment and program participation.
Standards of Conduct
14 CFR Part 1207 establishes standards of conduct for NASA employees, requiring compliance with executive branch-wide ethical conduct standards. It prohibits employees from participating in matters where they have a financial interest that could directly affect that interest, and establishes procedures for requesting and granting waivers of this prohibition through designated NASA officials based on employee position and location.
To Research, Evaluate, Assess, and Treat (TREAT) Astronauts
This regulation establishes a NASA program to provide medical monitoring, diagnosis, and treatment for former U.S. Government astronauts and payload specialists for conditions potentially associated with spaceflight. Eligible individuals receive covered medical care at no cost to them, with NASA serving as secondary payer. Care is limited to spaceflight-associated conditions and may be provided locally if travel to NASA Johnson Space Center is inadvisable.
Protection of Human Subjects
21 CFR Part 50 establishes requirements for the protection of human subjects in clinical investigations regulated by the FDA. It applies to investigations involving drugs, biological products, medical devices, food additives, dietary supplements, and related products submitted for FDA approval. The regulation defines the scope of coverage, applicable regulatory sections, and key definitions for research and marketing permit applications across multiple FDA-regulated product categories.
Epidemiology and Other Health Studies Financial Assistance Program
DOE regulation establishing grant and cooperative agreement procedures for epidemiological and health studies research, education, and communication activities. Covers health effects from DOE operations and energy production, including studies of worker and community health near DOE facilities, toxic substance exposure (including beryllium), and biomarker use for exposure recognition.
Security Policies and Practices Relating to Labor-Management Relations
This DOE regulation establishes security policies and practices governing labor-management relations at Department of Energy installations. It sets forth procedures for National Labor Relations Board proceedings at DOE facilities, emphasizing balance between security requirements and traditional labor rights. Key provisions include encouragement of consent elections, maintenance of cleared administrative law judges, counsel clearance procedures, and DOE oversight of contested proceedings to protect classified information while ensuring material evidence is included in unclassified records.
Workplace Substance Abuse Programs at DOE Sites
10 CFR Part 707 establishes workplace substance abuse testing programs for DOE contractors and subcontractors at sites operated under the Atomic Energy Act. The rule requires drug testing for employees in designated positions with access to classified information, special nuclear materials, or hazardous materials, or those working in high-risk environments. Testing procedures include pre-employment screening, random testing, reasonable suspicion testing, and post-incident testing, with confirmed positive results determined by gas chromatography/mass spectrometry.
Human Cells, Tissues, and Cellular and Tissue-Based Products
21 CFR Part 1271 establishes FDA requirements for establishments manufacturing human cells, tissues, and cellular and tissue-based products (HCT/Ps). The regulation creates an electronic registration and listing system and mandates compliance with donor-eligibility procedures, current good tissue practice standards, and communicable disease prevention measures. It applies to HCT/P manufacturers regulated under the Public Health Service Act, whether or not products enter interstate commerce, and requires adherence to manufacturing and quality standards.
Additional Standards for Human Blood and Blood Products
21 CFR Part 640 establishes manufacturing and quality standards for human whole blood and blood products intended for transfusion. Requirements cover donor examination, blood collection using sterile pyrogen-free containers with approved anticoagulants, storage at 1–6 °C, labeling, tamper-proof sealing, and aseptic processing to prevent contamination. Licensed establishments must supervise all manufacturing steps including donor identification, laboratory testing, and reissue conditions.
Extralabel Drug Use in Animals
21 CFR Part 530 establishes conditions for extralabel use of FDA-approved drugs in animals by licensed veterinarians. Extralabel use—employing approved drugs in species, indications, dosages, or routes not on the label—is permitted only when animal health is threatened and within a valid veterinary-client-patient relationship. The rule prohibits advertising extralabel uses and requires veterinary records for FDA oversight and public health protection.
Current Good Manufacturing Practice for Blood and Blood Components
21 CFR Part 606 establishes current good manufacturing practice (cGMP) standards for blood and blood components collection, processing, compatibility testing, storage and distribution. The regulation defines key terms including blood, blood components, plasmapheresis, plateletpheresis, and leukapheresis procedures. It requires facilities and personnel to maintain adequate safety, purity, potency and effectiveness, with personnel having appropriate education, training and experience. Facilities must be clean, orderly, suitably constructed and properly maintained to ensure compliance with cGMP requirements.
Control of Communicable Diseases
21 CFR Part 1240 establishes FDA regulations for controlling communicable diseases through sanitation and quarantine measures. The regulation defines key terms including communicable diseases, contamination, conveyances, garbage, incubation periods, and milk/milk products. It specifies requirements for interstate traffic involving conveyances and persons, and sets minimum heat treatment standards (boiling for 30+ minutes) for garbage in food-handling establishments including houses, restaurants, hotels, and kitchens.
Additional Standards for Miscellaneous Products
21 CFR Part 680 establishes standards for allergenic products used in diagnosis, prevention, or treatment of allergies. Requirements cover source material purity (max 1% foreign material), mold culture processing with approved standard operating procedures, and animal sourcing with veterinary oversight. Manufacturers must document mold identity, processing steps, contamination limits, and report specified animal diseases to the Center for Biologics Evaluation and Research.
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.
Process Safety Management of Highly Hazardous Chemicals
Process safety management requirements for facilities handling highly hazardous chemicals above threshold quantities, including PHA, MOC, and mechanical integrity.