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I. Overall Requirements
Criterion 1—Quality standards and records. Structures, systems, and components important to safety shall be designed, fabricated, erected, and tested to quality standards commensurate with the importance of the safety functions to be performed. Where generally recognized codes and standards are used, they shall be identified and evaluated to determine their applicability, adequacy, and sufficiency and shall be supplemented or modified as necessary to assure a quality product in keeping with the required safety function. A quality assurance program shall be established and implemented in order to provide adequate assurance that these structures, systems, and components will satisfactorily perform their safety functions. Appropriate records of the design, fabrication, erection, and testing of structures, systems, and components important to safety shall be maintained by or under the control of the nuclear power unit licensee throughout the life of the unit.
Criterion 2—Design bases for protection against natural phenomena. Structures, systems, and components important to safety shall be designed to withstand the effects of natural phenomena such as earthquakes, tornadoes, hurricanes, floods, tsunami, and seiches without loss of capability to perform their safety functions. The design bases for these structures, systems, and components shall reflect: (1) Appropriate consideration of the most severe of the natural phenomena that have been historically reported for the site and surrounding area, with sufficient margin for the limited accuracy, quantity, and period of time in which the historical data have been accumulated, (2) appropriate combinations of the effects of normal and accident conditions with the effects of the natural phenomena and (3) the importance of the safety functions to be performed.
Criterion 3—Fire protection. Structures, systems, and components important to safety shall be designed and located to minimize, consistent with other safety requirements, the probability and effect of fires and explosions. Noncombustible and heat resistant materials shall be used wherever practical throughout the unit, particularly in locations such as the containment and control room. Fire detection and fighting systems of appropriate capacity and capability shall be provided and designed to minimize the adverse effects of fires on structures, systems, and components important to safety. Firefighting systems shall be designed to assure that their rupture or inadvertent operation does not significantly impair the safety capability of these structures, systems, and components.
Criterion 4—Environmental and dynamic effects design bases. Structures, systems, and components important to safety shall be designed to accommodate the effects of and to be compatible with the environmental conditions associated with normal operation, maintenance, testing, and postulated accidents, including loss-of-coolant accidents. These structures, systems, and components shall be appropriately protected against dynamic effects, including the effects of missiles, pipe whipping, and discharging fluids, that may result from equipment failures and from events and conditions outside the nuclear power unit. However, dynamic effects associated with postulated pipe ruptures in nuclear power units may be excluded from the design basis when analyses reviewed and approved by the Commission demonstrate that the probability of fluid system piping rupture is extremely low under conditions consistent with the design basis for the piping.
Criterion 5—Sharing of structures, systems, and components. Structures, systems, and components important to safety shall not be shared among nuclear power units unless it can be shown that such sharing will not significantly impair their ability to perform their safety functions, including, in the event of an accident in one unit, an orderly shutdown and cooldown of the remaining units.
II. Protection by Multiple Fission Product Barriers
Criterion 10—Reactor design. The reactor core and associated coolant, control, and protection systems shall be designed with appropriate margin to assure that specified acceptable fuel design limits are not exceeded during any condition of normal operation, including the effects of anticipated operational occurrences.
Criterion 11—Reactor inherent protection. The reactor core and associated coolant systems shall be designed so that in the power operating range the net effect of the prompt inherent nuclear feedback characteristics tends to compensate for a rapid increase in reactivity.
Criterion 12—Suppression of reactor power oscillations. The reactor core and associated coolant, control, and protection systems shall be designed to assure that power oscillations which can result in conditions exceeding specified acceptable fuel design limits are not possible or can be reliably and readily detected and suppressed.
Criterion 13—Instrumentation and control. Instrumentation shall be provided to monitor variables and systems over their anticipated ranges for normal operation, for anticipated operational occurrences, and for accident conditions as appropriate to assure adequate safety, including those variables and systems that can affect the fission process, the integrity of the reactor core, the reactor coolant pressure boundary, and the containment and its associated systems. Appropriate controls shall be provided to maintain these variables and systems within prescribed operating ranges.
Criterion 14—Reactor coolant pressure boundary. The reactor coolant pressure boundary shall be designed, fabricated, erected, and tested so as to have an extremely low probability of abnormal leakage, of rapidly propagating failure, and of gross rupture.
Criterion 15—Reactor coolant system design. The reactor coolant system and associated auxiliary, control, and protection systems shall be designed with sufficient margin to assure that the design conditions of the reactor coolant pressure boundary are not exceeded during any condition of normal operation, including anticipated operational occurrences.
Criterion 16—Containment design. Reactor containment and associated systems shall be provided to establish an essentially leak-tight barrier against the uncontrolled release of radioactivity to the environment and to assure that the containment design conditions important to safety are not exceeded for as long as postulated accident conditions require.
Criterion 17—Electric power systems. An onsite electric power system and an offsite electric power system shall be provided to permit functioning of structures, systems, and components important to safety. The safety function for each system (assuming the other system is not functioning) shall be to provide sufficient capacity and capability to assure that (1) specified acceptable fuel design limits and design conditions of the reactor coolant pressure boundary are not exceeded as a result of anticipated operational occurrences and (2) the core is cooled and containment integrity and other vital functions are maintained in the event of postulated accidents.
The onsite electric power supplies, including the batteries, and the onsite electric distribution system, shall have sufficient independence, redundancy, and testability to perform their safety functions assuming a single failure.
Electric power from the transmission network to the onsite electric distribution system shall be supplied by two physically independent circuits (not necessarily on separate rights of way) designed and located so as to minimize to the extent practical the likelihood of their simultaneous failure under operating and postulated accident and environmental conditions. A switchyard common to both circuits is acceptable. Each of these circuits shall be designed to be available in sufficient time following a loss of all onsite alternating current power supplies and the other offsite electric power circuit, to assure that specified acceptable fuel design limits and design conditions of the reactor coolant pressure boundary are not exceeded. One of these circuits shall be designed to be available within a few seconds following a loss-of-coolant accident to assure that core cooling, containment integrity, and other vital safety functions are maintained.
Provisions shall be included to minimize the probability of losing electric power from any of the remaining supplies as a result of, or coincident with, the loss of power generated by the nuclear power unit, the loss of power from the transmission network, or the loss of power from the onsite electric power supplies.
Criterion 18—Inspection and testing of electric power systems. Electric power systems important to safety shall be designed to permit appropriate periodic inspection and testing of important areas and features, such as wiring, insulation, connections, and switchboards, to assess the continuity of the systems and the condition of their components. The systems shall be designed with a capability to test periodically (1) the operability and functional performance of the components of the systems, such as onsite power sources, relays, switches, and buses, and (2) the operability of the systems as a whole and, under conditions as close to design as practical, the full operation sequence that brings the systems into operation, including operation of applicable portions of the protection system, and the transfer of power among the nuclear power unit, the offsite power system, and the onsite power system.
Criterion 19—Control room. A control room shall be provided from which actions can be taken to operate the nuclear power unit safely under normal conditions and to maintain it in a safe condition under accident conditions, including loss-of-coolant accidents. Adequate radiation protection shall be provided to permit access and occupancy of the control room under accident conditions without personnel receiving radiation exposures in excess of 5 rem whole body, or its equivalent to any part of the body, for the duration of the accident. Equipment at appropriate locations outside the control room shall be provided (1) with a design capability for prompt hot shutdown of the reactor, including necessary instrumentation and controls to maintain the unit in a safe condition during hot shutdown, and (2) with a potential capability for subsequent cold shutdown of the reactor through the use of suitable procedures.
Applicants for and holders of construction permits and operating licenses under this part who apply on or after January 10, 1997, applicants for design approvals or certifications under part 52 of this chapter who apply on or after January 10, 1997, applicants for and holders of combined licenses or manufacturing licenses under part 52 of this chapter who do not reference a standard design approval or certification, or holders of operating licenses using an alternative source term under § 50.67, shall meet the requirements of this criterion, except that with regard to control room access and occupancy, adequate radiation protection shall be provided to ensure that radiation exposures shall not exceed 0.05 Sv (5 rem) total effective dose equivalent (TEDE) as defined in § 50.2 for the duration of the accident.
III. Protection and Reactivity Control Systems
Criterion 20—Protection system functions. The protection system shall be designed (1) to initiate automatically the operation of appropriate systems including the reactivity control systems, to assure that specified acceptable fuel design limits are not exceeded as a result of anticipated operational occurrences and (2) to sense accident conditions and to initiate the operation of systems and components important to safety.
Criterion 21—Protection system reliability and testability. The protection system shall be designed for high functional reliability and inservice testability commensurate with the safety functions to be performed. Redundancy and independence designed into the protection system shall be sufficient to assure that (1) no single failure results in loss of the protection function and (2) removal from service of any component or channel does not result in loss of the required minimum redundancy unless the acceptable reliability of operation of the protection system can be otherwise demonstrated. The protection system shall be designed to permit periodic testing of its functioning when the reactor is in operation, including a capability to test channels independently to determine failures and losses of redundancy that may have occurred.
Criterion 22—Protection system independence. The protection system shall be designed to assure that the effects of natural phenomena, and of normal operating, maintenance, testing, and postulated accident conditions on redundant channels do not result in loss of the protection function, or shall be demonstrated to be acceptable on some other defined basis. Design techniques, such as functional diversity or diversity in component design and principles of operation, shall be used to the extent practical to prevent loss of the protection function.
Criterion 23—Protection system failure modes. The protection system shall be designed to fail into a safe state or into a state demonstrated to be acceptable on some other defined basis if conditions such as disconnection of the system, loss of energy (e.g., electric power, instrument air), or postulated adverse environments (e.g., extreme heat or cold, fire, pressure, steam, water, and radiation) are experienced.
Criterion 24—Separation of protection and control systems. The protection system shall be separated from control systems to the extent that failure of any single control system component or channel, or failure or removal from service of any single protection system component or channel which is common to the control and protection systems leaves intact a system satisfying all reliability, redundancy, and independence requirements of the protection system. Interconnection of the protection and control systems shall be limited so as to assure that safety is not significantly impaired.
Criterion 25—Protection system requirements for reactivity control malfunctions. The protection system shall be designed to assure that specified acceptable fuel design limits are not exceeded for any single malfunction of the reactivity control systems, such as accidental withdrawal (not ejection or dropout) of control rods.
Criterion 26—Reactivity control system redundancy and capability. Two independent reactivity control systems of different design principles shall be provided. One of the systems shall use control rods, preferably including a positive means for inserting the rods, and shall be capable of reliably controlling reactivity changes to assure that under conditions of normal operation, including anticipated operational occurrences, and with appropriate margin for malfunctions such as stuck rods, specified acceptable fuel design limits are not exceeded. The second reactivity control system shall be capable of reliably controlling the rate of reactivity changes resulting from planned, normal power changes (including xenon burnout) to assure acceptable fuel design limits are not exceeded. One of the systems shall be capable of holding the reactor core subcritical under cold conditions.
Criterion 27—Combined reactivity control systems capability. The reactivity control systems shall be designed to have a combined capability, in conjunction with poison addition by the emergency core cooling system, of reliably controlling reactivity changes to assure that under postulated accident conditions and with appropriate margin for stuck rods the capability to cool the core is maintained.
Criterion 28—Reactivity limits. The reactivity control systems shall be designed with appropriate limits on the potential amount and rate of reactivity increase to assure that the effects of postulated reactivity accidents can neither (1) result in damage to the reactor coolant pressure boundary greater than limited local yielding nor (2) sufficiently disturb the core, its support structures or other reactor pressure vessel internals to impair significantly the capability to cool the core. These postulated reactivity accidents shall include consideration of rod ejection (unless prevented by positive means), rod dropout, steam line rupture, changes in reactor coolant temperature and pressure, and cold water addition.
Criterion 29—Protection against anticipated operational occurrences. The protection and reactivity control systems shall be designed to assure an extremely high probability of accomplishing their safety functions in the event of anticipated operational occurrences.
IV. Fluid Systems
Criterion 30—Quality of reactor coolant pressure boundary. Components which are part of the reactor coolant pressure boundary shall be designed, fabricated, erected, and tested to the highest quality standards practical. Means shall be provided for detecting and, to the extent practical, identifying the location of the source of reactor coolant leakage.
Criterion 31—Fracture prevention of reactor coolant pressure boundary. The reactor coolant pressure boundary shall be designed with sufficient margin to assure that when stressed under operating, maintenance, testing, and postulated accident conditions (1) the boundary behaves in a nonbrittle manner and (2) the probability of rapidly propagating fracture is minimized. The design shall reflect consideration of service temperatures and other conditions of the boundary material under operating, maintenance, testing, and postulated accident conditions and the uncertainties in determining (1) material properties, (2) the effects of irradiation on material properties, (3) residual, steady state and transient stresses, and (4) size of flaws.
Criterion 32—Inspection of reactor coolant pressure boundary. Components which are part of the reactor coolant pressure boundary shall be designed to permit (1) periodic inspection and testing of important areas and features to assess their structural and leaktight integrity, and (2) an appropriate material surveillance program for the reactor pressure vessel.
Criterion 33—Reactor coolant makeup. A system to supply reactor coolant makeup for protection against small breaks in the reactor coolant pressure boundary shall be provided. The system safety function shall be to assure that specified acceptable fuel design limits are not exceeded as a result of reactor coolant loss due to leakage from the reactor coolant pressure boundary and rupture of small piping or other small components which are part of the boundary. The system shall be designed to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished using the piping, pumps, and valves used to maintain coolant inventory during normal reactor operation.
Criterion 34—Residual heat removal. A system to remove residual heat shall be provided. The system safety function shall be to transfer fission product decay heat and other residual heat from the reactor core at a rate such that specified acceptable fuel design limits and the design conditions of the reactor coolant pressure boundary are not exceeded.
Suitable redundancy in components and features, and suitable interconnections, leak detection, and isolation capabilities shall be provided to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished, assuming a single failure.
Criterion 35—Emergency core cooling. A system to provide abundant emergency core cooling shall be provided. The system safety function shall be to transfer heat from the reactor core following any loss of reactor coolant at a rate such that (1) fuel and clad damage that could interfere with continued effective core cooling is prevented and (2) clad metal-water reaction is limited to negligible amounts.
Suitable redundancy in components and features, and suitable interconnections, leak detection, isolation, and containment capabilities shall be provided to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished, assuming a single failure.
Criterion 36—Inspection of emergency core cooling system. The emergency core cooling system shall be designed to permit appropriate periodic inspection of important components, such as spray rings in the reactor pressure vessel, water injection nozzles, and piping, to assure the integrity and capability of the system.
Criterion 37—Testing of emergency core cooling system. The emergency core cooling system shall be designed to permit appropriate periodic pressure and functional testing to assure (1) the structural and leaktight integrity of its components, (2) the operability and performance of the active components of the system, and (3) the operability of the system as a whole and, under conditions as close to design as practical, the performance of the full operational sequence that brings the system into operation, including operation of applicable portions of the protection system, the transfer between normal and emergency power sources, and the operation of the associated cooling water system.
Criterion 38—Containment heat removal. A system to remove heat from the reactor containment shall be provided. The system safety function shall be to reduce rapidly, consistent with the functioning of other associated systems, the containment pressure and temperature following any loss-of-coolant accident and maintain them at acceptably low levels.
Suitable redundancy in components and features, and suitable interconnections, leak detection, isolation, and containment capabilities shall be provided to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished, assuming a single failure.
Criterion 39—Inspection of containment heat removal system. The containment heat removal system shall be designed to permit appropriate periodic inspection of important components, such as the torus, sumps, spray nozzles, and piping to assure the integrity and capability of the system.
Criterion 40—Testing of containment heat removal system. The containment heat removal system shall be designed to permit appropriate periodic pressure and functional testing to assure (1) the structural and leaktight integrity of its components, (2) the operability and performance of the active components of the system, and (3) the operability of the system as a whole, and under conditions as close to the design as practical the performance of the full operational sequence that brings the system into operation, including operation of applicable portions of the protection system, the transfer between normal and emergency power sources, and the operation of the associated cooling water system.
Criterion 41—Containment atmosphere cleanup. Systems to control fission products, hydrogen, oxygen, and other substances which may be released into the reactor containment shall be provided as necessary to reduce, consistent with the functioning of other associated systems, the concentration and quality of fission products released to the environment following postulated accidents, and to control the concentration of hydrogen or oxygen and other substances in the containment atmosphere following postulated accidents to assure that containment integrity is maintained.
Each system shall have suitable redundancy in components and features, and suitable interconnections, leak detection, isolation, and containment capabilities to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) its safety function can be accomplished, assuming a single failure.
Criterion 42—Inspection of containment atmosphere cleanup systems. The containment atmosphere cleanup systems shall be designed to permit appropriate periodic inspection of important components, such as filter frames, ducts, and piping to assure the integrity and capability of the systems.
Criterion 43—Testing of containment atmosphere cleanup systems. The containment atmosphere cleanup systems shall be designed to permit appropriate periodic pressure and functional testing to assure (1) the structural and leaktight integrity of its components, (2) the operability and performance of the active components of the systems such as fans, filters, dampers, pumps, and valves and (3) the operability of the systems as a whole and, under conditions as close to design as practical, the performance of the full operational sequence that brings the systems into operation, including operation of applicable portions of the protection system, the transfer between normal and emergency power sources, and the operation of associated systems.
Criterion 44—Cooling water. A system to transfer heat from structures, systems, and components important to safety, to an ultimate heat sink shall be provided. The system safety function shall be to transfer the combined heat load of these structures, systems, and components under normal operating and accident conditions.
Suitable redundancy in components and features, and suitable interconnections, leak detection, and isolation capabilities shall be provided to assure that for onsite electric power system operation (assuming offsite power is not available) and for offsite electric power system operation (assuming onsite power is not available) the system safety function can be accomplished, assuming a single failure.
Criterion 45—Inspection of cooling water system. The cooling water system shall be designed to permit appropriate periodic inspection of important components, such as heat exchangers and piping, to assure the integrity and capability of the system.
Criterion 46—Testing of cooling water system. The cooling water system shall be designed to permit appropriate periodic pressure and functional testing to assure (1) the structural and leaktight integrity of its components, (2) the operability and the performance of the active components of the system, and (3) the operability of the system as a whole and, under conditions as close to design as practical, the performance of the full operational sequence that brings the system into operation for reactor shutdown and for loss-of-coolant accidents, including operation of applicable portions of the protection system and the transfer between normal and emergency power sources.
V. Reactor Containment
Criterion 50—Containment design basis. The reactor containment structure, including access openings, penetrations, and the containment heat removal system shall be designed so that the containment structure and its internal compartments can accommodate, without exceeding the design leakage rate and with sufficient margin, the calculated pressure and temperature conditions resulting from any loss-of-coolant accident. This margin shall reflect consideration of (1) the effects of potential energy sources which have not been included in the determination of the peak conditions, such as energy in steam generators and as required by § 50.44 energy from metal-water and other chemical reactions that may result from degradation but not total failure of emergency core cooling functioning, (2) the limited experience and experimental data available for defining accident phenomena and containment responses, and (3) the conservatism of the calculational model and input parameters.
Criterion 51—Fracture prevention of containment pressure boundary. The reactor containment boundary shall be designed with sufficient margin to assure that under operating, maintenance, testing, and postulated accident conditions (1) its ferritic materials behave in a nonbrittle manner and (2) the probability of rapidly propagating fracture is minimized. The design shall reflect consideration of service temperatures and other conditions of the containment boundary material during operation, maintenance, testing, and postulated accident conditions, and the uncertainties in determining (1) material properties, (2) residual, steady state, and transient stresses, and (3) size of flaws.
Criterion 52—Capability for containment leakage rate testing. The reactor containment and other equipment which may be subjected to containment test conditions shall be designed so that periodic integrated leakage rate testing can be conducted at containment design pressure.
Criterion 53—Provisions for containment testing and inspection. The reactor containment shall be designed to permit (1) appropriate periodic inspection of all important areas, such as penetrations, (2) an appropriate surveillance program, and (3) periodic testing at containment design pressure of the leaktightness of penetrations which have resilient seals and expansion bellows.
Criterion 54—Piping systems penetrating containment. Piping systems penetrating primary reactor containment shall be provided with leak detection, isolation, and containment capabilities having redundancy, reliability, and performance capabilities which reflect the importance to safety of isolating these piping systems. Such piping systems shall be designed with a capability to test periodically the operability of the isolation valves and associated apparatus and to determine if valve leakage is within acceptable limits.
Criterion 55—Reactor coolant pressure boundary penetrating containment. Each line that is part of the reactor coolant pressure boundary and that penetrates primary reactor containment shall be provided with containment isolation valves as follows, unless it can be demonstrated that the containment isolation provisions for a specific class of lines, such as instrument lines, are acceptable on some other defined basis:
(1) One locked closed isolation valve inside and one locked closed isolation valve outside containment; or
(2) One automatic isolation valve inside and one locked closed isolation valve outside containment; or
(3) One locked closed isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment; or
(4) One automatic isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment.
Isolation valves outside containment shall be located as close to containment as practical and upon loss of actuating power, automatic isolation valves shall be designed to take the position that provides greater safety.
Other appropriate requirements to minimize the probability or consequences of an accidental rupture of these lines or of lines connected to them shall be provided as necessary to assure adequate safety. Determination of the appropriateness of these requirements, such as higher quality in design, fabrication, and testing, additional provisions for inservice inspection, protection against more severe natural phenomena, and additional isolation valves and containment, shall include consideration of the population density, use characteristics, and physical characteristics of the site environs.
Criterion 56—Primary containment isolation. Each line that connects directly to the containment atmosphere and penetrates primary reactor containment shall be provided with containment isolation valves as follows, unless it can be demonstrated that the containment isolation provisions for a specific class of lines, such as instrument lines, are acceptable on some other defined basis:
(1) One locked closed isolation valve inside and one locked closed isolation valve outside containment; or
(2) One automatic isolation valve inside and one locked closed isolation valve outside containment; or
(3) One locked closed isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment; or
(4) One automatic isolation valve inside and one automatic isolation valve outside containment. A simple check valve may not be used as the automatic isolation valve outside containment.
Isolation valves outside containment shall be located as close to the containment as practical and upon loss of actuating power, automatic isolation valves shall be designed to take the position that provides greater safety.
Criterion 57—Closed system isolation valves. Each line that penetrates primary reactor containment and is neither part of the reactor coolant pressure boundary nor connected directly to the containment atmosphere shall have at least one containment isolation valve which shall be either automatic, or locked closed, or capable of remote manual operation. This valve shall be outside containment and located as close to the containment as practical. A simple check valve may not be used as the automatic isolation valve.
VI. Fuel and Radioactivity Control
Criterion 60—Control of releases of radioactive materials to the environment. The nuclear power unit design shall include means to control suitably the release of radioactive materials in gaseous and liquid effluents and to handle radioactive solid wastes produced during normal reactor operation, including anticipated operational occurrences. Sufficient holdup capacity shall be provided for retention of gaseous and liquid effluents containing radioactive materials, particularly where unfavorable site environmental conditions can be expected to impose unusual operational limitations upon the release of such effluents to the environment.
Criterion 61—Fuel storage and handling and radioactivity control. The fuel storage and handling, radioactive waste, and other systems which may contain radioactivity shall be designed to assure adequate safety under normal and postulated accident conditions. These systems shall be designed (1) with a capability to permit appropriate periodic inspection and testing of components important to safety, (2) with suitable shielding for radiation protection, (3) with appropriate containment, confinement, and filtering systems, (4) with a residual heat removal capability having reliability and testability that reflects the importance to safety of decay heat and other residual heat removal, and (5) to prevent significant reduction in fuel storage coolant inventory under accident conditions.
Criterion 62—Prevention of criticality in fuel storage and handling. Criticality in the fuel storage and handling system shall be prevented by physical systems or processes, preferably by use of geometrically safe configurations.
Criterion 63—Monitoring fuel and waste storage. Appropriate systems shall be provided in fuel storage and radioactive waste systems and associated handling areas (1) to detect conditions that may result in loss of residual heat removal capability and excessive radiation levels and (2) to initiate appropriate safety actions.
Criterion 64—Monitoring radioactivity releases. Means shall be provided for monitoring the reactor containment atmosphere, spaces containing components for recirculation of loss-of-coolant accident fluids, effluent discharge paths, and the plant environs for radioactivity that may be released from normal operations, including anticipated operational occurrences, and from postulated accidents.

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Appendix B to Part 50—Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants
Introduction. Every applicant for a construction permit is required by the provisions of § 50.34 to include in its preliminary safety analysis report a description of the quality assurance program to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility. Every applicant for an operating license is required to include, in its final safety analysis report, information pertaining to the managerial and administrative controls to be used to assure safe operation. Every applicant for a combined license under part 52 of this chapter is required by the provisions of § 52.79 of this chapter to include in its final safety analysis report a description of the quality assurance applied to the design, and to be applied to the fabrication, construction, and testing of the structures, systems, and components of the facility and to the managerial and administrative controls to be used to assure safe operation. For applications submitted after September 27, 2007, every applicant for an early site permit under part 52 of this chapter is required by the provisions of § 52.17 of this chapter to include in its site safety analysis report a description of the quality assurance program applied to site activities related to the design, fabrication, construction, and testing of the structures, systems, and components of a facility or facilities that may be constructed on the site. Every applicant for a design approval or design certification under part 52 of this chapter is required by the provisions of 10 CFR 52.137 and 52.47, respectively, to include in its final safety analysis report a description of the quality assurance program applied to the design of the structures, systems, and components of the facility. Every applicant for a manufacturing license under part 52 of this chapter is required by the provisions of 10 CFR 52.157 to include in its final safety analysis report a description of the quality assurance program applied to the design, and to be applied to the manufacture of, the structures, systems, and components of the reactor. Nuclear power plants and fuel reprocessing plants include structures, systems, and components that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. This appendix establishes quality assurance requirements for the design, manufacture, construction, and operation of those structures, systems, and components. The pertinent requirements of this appendix apply to all activities affecting the safety-related functions of those structures, systems, and components; these activities include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying.
As used in this appendix, "quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to the physical characteristics of a material, structure, component, or system which provide a means to control the quality of the material, structure, component, or system to predetermined requirements.
I. Organization
The applicant 1 shall be responsible for the establishment and execution of the quality assurance program. The applicant may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part thereof, but shall retain responsibility for the quality assurance program. The authority and duties of persons and organizations performing activities affecting the safety-related functions of structures, systems, and components shall be clearly established and delineated in writing. These activities include both the performing functions of attaining quality objectives and the quality assurance functions. The quality assurance functions are those of (1) assuring that an appropriate quality assurance program is established and effectively executed; and (2) verifying, such as by checking, auditing, and inspecting, that activities affecting the safety-related functions have been correctly performed. The persons and organizations performing quality assurance functions shall have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions. The persons and organizations performing quality assurance functions shall report to a management level so that the required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations, are provided. Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the quality assurance program may take various forms, provided that the persons and organizations assigned the quality assurance functions have the required authority and organizational freedom. Irrespective of the organizational structure, the individual(s) assigned the responsibility for assuring effective execution of any portion of the quality assurance program at any location where activities subject to this appendix are being performed, shall have direct access to the levels of management necessary to perform this function.
II. Quality Assurance Program
The applicant shall establish at the earliest practicable time, consistent with the schedule for accomplishing the activities, a quality assurance program which complies with the requirements of this appendix. This program shall be documented by written policies, procedures, or instructions and shall be carried out throughout plant life in accordance with those policies, procedures, or instructions. The applicant shall identify the structures, systems, and components to be covered by the quality assurance program and the major organizations participating in the program, together with the designated functions of these organizations. The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety. Activities affecting quality shall be accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the activity, such as adequate cleanness; and assurance that all prerequisites for the given activity have been satisfied. The program shall take into account the need for special controls, processes, test equipment, tools, and skills to attain the required quality, and the need for verification of quality by inspection and test. The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained. The applicant shall regularly review the status and adequacy of the quality assurance program. Management of other organizations participating in the quality assurance program shall regularly review the status and adequacy of that part of the quality assurance program which they are executing.
III. Design Control
Measures shall be established to assure that applicable regulatory requirements and the design basis, as defined in § 50.2 and as specified in the license application, for those structures, systems, and components to which this appendix applies are correctly translated into specifications, drawings, procedures, and instructions. These measures shall include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled. Measures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components.
Measures shall be established for the identification and control of design interfaces and for coordination among participating design organizations. These measures shall include the establishment of procedures among participating design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces.
The design control measures shall provide for verifying or checking the adequacy of design, such as by the performance of design reviews, by the use of alternate or simplified calculational methods, or by the performance of a suitable testing program. The verifying or checking process shall be performed by individuals or groups other than those who performed the original design, but who may be from the same organization. Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying or checking processes, it shall include suitable qualifications testing of a prototype unit under the most adverse design conditions. Design control measures shall be applied to items such as the following: reactor physics, stress, thermal, hydraulic, and accident analyses; compatibility of materials; accessibility for inservice inspection, maintenance, and repair; and delineation of acceptance criteria for inspections and tests.
Design changes, including field changes, shall be subject to design control measures commensurate with those applied to the original design and be approved by the organization that performed the original design unless the applicant designates another responsible organization.
IV. Procurement Document Control
Measures shall be established to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the applicant or by its contractors or subcontractors. To the extent necessary, procurement documents shall require contractors or subcontractors to provide a quality assurance program consistent with the pertinent provisions of this appendix.
V. Instructions, Procedures, and Drawings
Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings. Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
VI. Document Control
Measures shall be established to control the issuance of documents, such as instructions, procedures, and drawings, including changes thereto, which prescribe all activities affecting quality. These measures shall assure that documents, including changes, are reviewed for adequacy and approved for release by authorized personnel and are distributed to and used at the location where the prescribed activity is performed. Changes to documents shall be reviewed and approved by the same organizations that performed the original review and approval unless the applicant designates another responsible organization.
VII. Control of Purchased Material, Equipment, and Services
Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. Documentary evidence that material and equipment conform to the procurement requirements shall be available at the nuclear powerplant or fuel reprocessing plant site prior to installation or use of such material and equipment. This documentary evidence shall be retained at the nuclear powerplant or fuel reprocessing plant site and shall be sufficient to identify the specific requirements, such as codes, standards, or specifications, met by the purchased material and equipment. The effectiveness of the control of quality by contractors and subcontractors shall be assessed by the applicant or designee at intervals consistent with the importance, complexity, and quantity of the product or services.
VIII. Identification and Control of Materials, Parts, and Components
Measures shall be established for the identification and control of materials, parts, and components, including partially fabricated assemblies. These measures shall assure that identification of the item is maintained by heat number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, erection, installation, and use of the item. These identification and control measures shall be designed to prevent the use of incorrect or defective material, parts, and components.
IX. Control of Special Processes
Measures shall be established to assure that special processes, including welding, heat treating, and nondestructive testing, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.
X. Inspection
A program for inspection of activities affecting quality shall be established and executed by or for the organization performing the activity to verify conformance with the documented instructions, procedures, and drawings for accomplishing the activity. Such inspection shall be performed by individuals other than those who performed the activity being inspected. Examinations, measurements, or tests of material or products processed shall be performed for each work operation where necessary to assure quality. If inspection of processed material or products is impossible or disadvantageous, indirect control by monitoring processing methods, equipment, and personnel shall be provided. Both inspection and process monitoring shall be provided when control is inadequate without both. If mandatory inspection hold points, which require witnessing or inspecting by the applicant's designated representative and beyond which work shall not proceed without the consent of its designated representative are required, the specific hold points shall be indicated in appropriate documents.
XI. Test Control
A test program shall be established to assure that all testing required to demonstrate that structures, systems, and components will perform satisfactorily in service is identified and performed in accordance with written test procedures which incorporate the requirements and acceptance limits contained in applicable design documents. The test program shall include, as appropriate, proof tests prior to installation, preoperational tests, and operational tests during nuclear power plant or fuel reprocessing plant operation, of structures, systems, and components. Test procedures shall include provisions for assuring that all prerequisites for the given test have been met, that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions. Test results shall be documented and evaluated to assure that test requirements have been satisfied.
XII. Control of Measuring and Test Equipment
Measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.
XIII. Handling, Storage and Shipping
Measures shall be established to control the handling, storage, shipping, cleaning and preservation of material and equipment in accordance with work and inspection instructions to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, specific moisture content levels, and temperature levels, shall be specified and provided.
XIV. Inspection, Test, and Operating Status
Measures shall be established to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the nuclear power plant or fuel reprocessing plant. These measures shall provide for the identification of items which have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent bypassing of such inspections and tests. Measures shall also be established for indicating the operating status of structures, systems, and components of the nuclear power plant or fuel reprocessing plant, such as by tagging valves and switches, to prevent inadvertent operation.
XV. Nonconforming Materials, Parts, or Components
Measures shall be established to control materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation. These measures shall include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures.
XVI. Corrective Action
Measures shall be established to assure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected. In the case of significant conditions adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.
XVII. Quality Assurance Records
Sufficient records shall be maintained to furnish evidence of activities affecting quality. The records shall include at least the following: Operating logs and the results of reviews, inspections, tests, audits, monitoring of work performance, and materials analyses. The records shall also include closely-related data such as qualifications of personnel, procedures, and equipment. Inspection and test records shall, as a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. Records shall be identifiable and retrievable. Consistent with applicable regulatory requirements, the applicant shall establish requirements concerning record retention, such as duration, location, and assigned responsibility.
XVIII. Audits
A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with the written procedures or check lists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audit results shall be documented and reviewed by management having responsibility in the area audited. Followup action, including reaudit of deficient areas, shall be taken where indicated.
1 While the term "applicant" is used in these criteria, the requirements are, of course, applicable after such a person has received a license to construct and operate a nuclear power plant or a fuel reprocessing plant or has received an early site permit, design approval, design certification, or manufacturing license, as applicable. These criteria will also be used for guidance in evaluating the adequacy of quality assurance programs in use by holders of construction permits, operating licenses, early site permits, design approvals, combined licenses, and manufacturing licenses.
[35 FR 10499, June 27, 1970, as amended at 36 FR 18301, Sept. 11, 1971; 40 FR 3210D, Jan. 20, 1975; 72 FR 49505, Aug. 28, 2007; 84 FR 63568, Nov. 18, 2019]
Page Last Reviewed/Updated Monday, June 14, 2021