(a) Activities that are regulated through a license by the Nuclear Regulatory Commission (NRC) or a State under an Agreement with the NRC, including activities certified by the NRC under section 1701 of the Atomic Energy Act;

(b) Activities conducted under the authority of the Director, Naval Nuclear Propulsion Program, as described in Public Law 98-525; or

(c) Activities conducted under the Nuclear Explosives and Weapons Safety Program relating to the prevention of accidental or unauthorized nuclear detonations.

Administrative Controls mean provisions relating to organization and management, procedures, record keeping, assessment, and reporting necessary to ensure safe operation of a facility.

Contractor means any person under contract with the Department of Energy with responsibility to perform activities in connection with a nuclear facility.

Department or DOE means the Department of Energy.

Document means recorded information that describes, specifies, reports, certifies, requires, or provides data or results. A document is not considered a record until it meets the definition of record.

Fissionable materials means a nuclide capable of sustaining a neutron-induced fission chain reaction (e.g., uranium-233, uranium-235, plutonium-238, plutonium-239, plutonium-241, neptunium- 237, americium-241, and curium-244).

Graded Approach means a process by which the level of analysis, documentation, and actions necessary to comply with a requirement in this part are commensurate with:

1. The relative importance to safety, safeguards, and security;

2. The magnitude of any hazard involved;

3. The life cycle stage of a facility;

4. The programmatic mission of a facility;

5. The particular characteristics of a facility; and

6. Any other relevant factor.

Implementation Plan means a document prepared by a contractor that sets forth:

1. When and how the actions appropriate to comply with the requirements of a section of this part, including the requirements of a plan or program required by the section, shall be taken, and

2. What relief will be sought if a contractor cannot attain full compliance with a requirement in a reasonable manner.

Nonreactor nuclear facility means those activities or operations that involve radioactive and/or fissionable materials in such form and quantity that a nuclear hazard potentially exists to the employees or the general public. Incidental use and generating of radioactive materials in a facility operation (e.g., check and calibration sources, use of radioactive sources in research and experimental and analytical laboratory activities, electron microscopes, and X-ray machines) would not ordinarily require the facility to be included in this definition. Transportation of radioactive materials, accelerators and reactors and their operations are not included. The application of any rule to a nonreactor nuclear facility shall be applied using a graded approach. Included are activities or operations that:

1. Produce, process, or store radioactive liquid or solid waste, fissionable materials, or tritium;

2. Conduct separations operations;

3. Conduct irradiated materials inspection, fuel fabrication, decontamination, or recovery operations;

4. Conduct fuel enrichment operations;

5. Perform environmental remediation or waste management activities involving radioactive materials; or

6. Design, manufacture, or assemble items for use with radioactive materials and/or fissionable materials in such form or quantity that a nuclear hazard potentially exists.

Person means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency, any State or political subdivision of, or any political entity within a State, any foreign government or nation or other entity and any legal successor, representative, agent or agency of the foregoing; provided that person does not include the Department or the United States NRC.

Process means a series of actions that achieves an end or result.

Quality means the condition achieved when an item, service, or process meets or exceeds the user's requirements and expectations.

Quality Assurance means all those actions that provide confidence that quality is achieved.

Quality Assurance Program or QAP means the overall program established to assign responsibilities and authorities, define policies and requirements, and provide for the performance and assessment of work.

Reactor means, unless it is modified by words such as containment, vessel, or core, the entire nuclear reactor facility, including the housing, equipment, and associated areas devoted to the operation and maintenance of one or more reactor cores. Any apparatus that is designed or used to sustain nuclear chain reactions in a controlled manner, including critical and pulsed assemblies and research, test, and power reactors, is defined as a reactor. All assemblies designed to perform subcritical experiments that could potentially reach criticality are also to be considered reactors. Critical assemblies are special nuclear devices designed and used to sustain nuclear reactions. Critical assemblies may be subject to frequent core and lattice configuration change and may be used frequently as mockups of reactor configurations.

Record means a completed document or other media that provides objective evidence of an item, service, or process.

Service means the performance of work, such as design, construction, fabrication, inspection, nondestructive examination/testing, environmental qualification, equipment qualification, repair, installation, or the like.

(2) Within 180 days after May 5, 1994, a contractor shall submit to DOE for approval a current QAP and an implementation plan.

(3) A contractor may, at any time, make changes to an approved QAP. Changes made over the previous year shall be submitted annually to DOE for review. A submittal shall identify the changes, the pages affected, the reason for the changes, and the basis for concluding that the revised QAP continues to satisfy the requirements of this section. Changes made to correct spelling, punctuation, or other editorial items do not require explanation.

(4) Implementation plans and QAPs shall be regarded as approved by DOE 90 days after submittal, unless approved or rejected by DOE at an earlier date, and shall include any modification made or directed by DOE.