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facility or a major modification to an existing DOE nuclear facility must prepare a preliminary documented safety analysis. A preliminary documented safety analysis can ensure that substantial costs and time are not wasted in constructing a nuclear facility that will not be acceptable to DOE. If a contractor is required to prepare a preliminary documented safety analysis, the contractor must obtain DOE approval of the preliminary documented safety analysis prior to procuring materials or components or beginning construction. DOE, however, may authorize the contractor to perform limited procurement and construction activities without approval of a preliminary documented safety analysis if DOE determines that the activities are not detrimental to public health and safety and are in the best interests of DOE. DOE Order 420.1, Facility Safety, sets forth acceptable nuclear safety design criteria for use in preparing a preliminary documented safety analysis. As a general matter, DOE does not expect preliminary documented safety analyses to be needed for activities that do not involve significant construction such as environmental restoration activities, decontamination and decommissioning activities, specific nuclear explosive operations, or transition surveillance and maintenance activities.

ics. For example, DOE Order 420.1 provides DOE's expectations with respect to fire protection and criticality safety.

3. Safety structures, systems, and compo nents require formal definition of minimum acceptable performance in the documented safety analysis. This is accomplished by first defining a safety function, then describing the structure, systems, and components placing functional requirements on those portions of the structures, systems, and com: ponents required for the safety function, and identifying performance criteria that will ensure functional requirements are met. Technical safety requirements are developed to ensure the operability of the safety struc tures, systems, and components and define actions to be taken if a safety structure, sys: tem, or component is not operable.

4. Technical safety requirements establish limits, controls, and related actions nec essary for the safe operation of a nuclear fa: cility. The exact form and contents of tech: nical safety requirements will depend on the circumstances of a particular nuclear facil ity as defined in the documented safety anal ysis for the nuclear facility. As appropriate technical safety requirements may have sec tions on (1) safety limits, (2) operating lim its, (3) surveillance requirements, (4) admin istrative controls, (5) use and application and (6) design features. It may also have a appendix on the bases for the limits and re quirements. DOE Guide 423.X, Implementa tion Guide for Use in Developing Technica Safety Requirements (TSRs) provides a com plete description of what technical safety re quirements should contain and how they should be developed and maintained.

5. DOE will examine and approve the tech nical safety requirements as part of pre paring the safety evaluation report and re viewing updates to the safety basis. As with all hazard controls, technical safety require ments must be kept current and refled changes in the facility, the work and th hazards as they are analyzed in the docu. mented safety analysis. In addition, DOE ex pects a contractor to maintain technica safety requirements, and other hazard con trols as appropriate, as controlled document with an authorized users list.

6. Table 4 sets forth DOE's expectation concerning acceptable technical safety re quirements.

This

G. HAZARD CONTROLS 1. Hazard controls are measures to eliminate, limit, or mitigate hazards to workers, the public, or the environment. They include (1) physical, design, structural, and engineering features; (2) safety structures, systems, and components; (3) safety management programs; (4) technical safety requirements; and (5) other controls necessary to provide adequate protection from hazards.

2. The types and specific characteristics of the safety management programs necessary for a DOE nuclear facility will be dependent on the complexity and hazards associated with the nuclear facility and the work being performed. In most cases, however, a contractor should consider safety management programs covering topics such as quality assurance, procedures, maintenance, personnel training, conduct of operations, criticality safety, emergency preparedness, fire protection, waste management, and radiation protection. In general, DOE Orders set forth DOE's expectations concerning specific top

TABLE 4

As atropriate for a particular DOE nuclear backty, the section of the technical safety

requirements on

Will provide information on

(1) Satety limits

12 Operating limits

Limiting control settings

umiting conditions for operations

The limits on process variables associated with those safety class physical bar

riers, generally passive, that are necessary for the intended facility function and that are required to guard against the uncontrolled release of radioactive materials. The safety limit section describes, as precisely as possible, the parameters being limited, states the limit in measurable units (pressure, temperature, flow, etc.), and indicates the applicability of the limit. The safety limit section also describes the actions to be taken in the event that the safety limit is exceeded. These actions should first place the facility in the safe, stable condition attainable, including total shutdown (except where such action might reduce the margin of safety) or should verify that the facility already is safe and stable and will remain so. The technical safety requirement should state that the contractor must obtain DOE authorization to restart the nuclear facility following a violation of a safety limit. The safety limit section also establishes the steps and time lim

its to correct the out-of-specification condition. Those limits which are required to ensure the safe operation of a nuclear facility.

The operating limits section may include subsections on limiting control settings

and limiting conditions for operation. The settings on safety systems that control process variables to prevent exceeding

a safety limit. The limited control settings section normally contains the settings for automatic alarms and for the automatic or nonautomatic initiation of protective actions related to those variables associated with the function of safety class structures, systems, or components if the safety analysis shows that they are relied upon to mitigate or prevent an accident. The limited control settings section also identifies the protective actions to be taken at the specific settings chosen in order to correct a situation automatically or manually such that the related safety limit is not exceeded. Protective actions may include maintaining the variables within the requirements and repairing the automatic device promptly or shutting

down the affected part of the process and, it required, the entire facility. The limits that represent the lowest functional capability or performance level of

safety structures, systems, and components required to perform an activity sately. The limiting conditions for operation section describes, as precisely as possible, the lowest functional capability or performance level of equipment required for continued safe operation of the facility. The limiting conditions for operation section also states the action to be taken to address a condition not meeting the limiting conditions for operation section. Normally this simply provides for the adverse condition being corrected in a certain time frame and for further action if

this is impossible. Requirements relating to test, calibration, or inspection to assure that the nec

essary operability and quality of safety structures, systems, and components is maintained; that facility operation is within safety limits; and that limiting control settings and limiting conditions for operation are met. If a required surveillance is not successfully completed, the contractor is expected to assume the systems or components involved are inoperable and take the actions defined by the technical safety requirement until the systems or components can be shown to be operable. If, however, a required surveillance is not performed within its required frequency, the contractor is allowed to perform the surveillance within 24 hours

or the original frequency, whichever is smaller, and confirm operability. Organization and management, procedures, recordkeeping, assessment, and re

porting necessary to ensure safe operation of a facility consistent with the technical safety requirement. In general, the administrative controls section addresses (1) the requirements associated with administrative controls, (including those for reporting violations of the technical safety requirement); (2) the staffing requirements for facility positions important to safe conduct of the facility; and (3) the commitments to the safety management programs identified in the documented safety analysis as necessary components of the safety basis for the fa

cility. The basic instructions for applying the safety restrictions contained in a technical

satety requirement. The use and application section includes definitions of terms,

operating modes, logical connectors, completion times, and frequency notations. Design features of the facility that, if altered or modified, would have a significant

effect on sale operation. The reasons for the safety limits, operating limits, and associated surveillance re

quirements in the technical safety requirements. The statements for each limit or requirement shows how the numeric value, the condition, or the surveillance fulfills the purpose derived from the safety documentation. The primary purpose for describing the basis of each limit or requirement is to ensure that any future changes to the limit or requirement is done with full knowledge of the original intent or purpose of the limit or requirement.

Surveillance requirements

Administrative controls

Use and application provisions

Design features

Bases appendix

835.4 Radiological units.

Subpart B-Management and

Administrative Requirements 835.101 Radiation protection programs. 835.102 Internal audits. 835.103 Education, training and skills. 835.104 Written procedures. Subpart C-Standards for Internal and

External Exposure 835.201 (Reserved] 835.202 Occupational dose limits for general

employees. 835.203 Combining internal and external

dose equivalents. 835.204 Planned special exposures. 835.205 Determination of compliance for

non-uniform exposure of the skin. 835.206 Limits for the embryo/fetus. 835.207 Occupational dose limits for minors. 835.208 Limits for members of the public en

tering a controlled area. 835.209 Concentrations of radioactive mate

rial in air.

H. UNREVIEWED SAFETY QUESTIONS 1. The USQ process is an important tool to evaluate whether changes affect the safety basis. A contractor must use the USQ process to ensure that the safety basis for a DOE nuclear facility is not undermined by changes in the facility, the work performed, the associated hazards, or other factors that support the adequacy of the safety basis.

2. The USQ process permits a contractor to make physical and procedural changes to a nuclear facility and to conduct tests and experiments without prior approval, provided these changes do not cause a USQ. The USQ process provides a contractor with the flexibility needed to conduct day-to-day operations by requiring only those changes and tests with a potential to impact the safety basis (and therefore the safety of the nuclear facility) be approved by DOE. This allows DOE to focus its review on those changes significant to safety. The USQ process helps keep the safety basis current by ensuring appropriate review of and response to situations that might adversely affect the safety basis.

3. DOE Guide 424.X, Implementation Guide for Addressing Unreviewed Safety Question (USQ) Requirements, provides DOE's expectations for a USQ process. The contractor must obtain DOE approval of its procedure used to implement the USQ process.

I. FUNCTIONS AND RESPONSIBILITIES 1. The DOE Management Official for a DOE nuclear facility (that is, the Assistant Secretary, the Assistant Administrator, or the Office Director who is primarily responsible for the management of the facility) has primary responsibility within DOE for ensuring that the safety basis for the facility is adequate and complies with the safety basis requirements of Part 830. The DOE Management Official is responsible for ensuring the timely and proper (1) review of all safety basis documents submitted to DOE and (2) preparation of a safety evaluation report concerning the safety basis for a facility.

2. DOE will maintain a public list on the internet that provides the status of the safety basis for each hazard category 1, 2, or 3 DOE nuclear facility and, to the extent practicable, provides information on how to obtain a copy of the safety basis and related documents for a facility.

Subpart D [Reserved) Subpart E-Monitoring of Individuals and

Areas 835.401 General requirements. 835.402 Individual monitoring. 835.403 Air monitoring. 835.404 [Reserved] 835.405 Receipt of packages containing ra

dioactive material.

Subpart F-Entry Control Program

835.501 Radiological areas. 835.502 High and very high radiation areas.

Subpart G-Posting and Labeling 835.601 General requirements. 835.602 Controlled areas. 835.603 Radiological areas and radioactive

material areas. 835.604 Exceptions to posting requirements. 835.605 Labeling items and containers. 835.606 Exceptions to labeling requirements.

Subpart H-Records

PART 835-OCCUPATIONAL RADIATION PROTECTION

835.701 General provisions. 835.702 Individual monitoring records. 835.703 Other monitoring records. 835.704 Administrative records.

Subpart I-Reports to Individuals

Subpart A-General Provisions

835.801 Reports to individuals.

Sec. 835.1 Scope. 835.2 Definitions. 835.3 General rule.

Subpart J—Radiation Safety Training 835.901 Radiation safety training.

1

835.902–835.903 (Reserved]

Subpart K-Design and Control 835.1001 Design and control. 835.1002 Facility design and modifications. 835.1003 Workplace controls.

Subpart 1-Radioactive Contamination

Control 835.1101 Control of material and equipment. 835.1102 Control of areas. Subpart M-Sealed Radioactive Source

Control

certified by the Nuclear Regulatory Commission under section 1701 of the Atomic Energy Act;

(2) Activities conducted under the authority of the Director, Naval Nuclear Propulsion Program, as described in Pub. L. 98-525;

(3) Activities conducted under the Nuclear Explosives and Weapons Surety Program relating to the prevention of accidental or unauthorized nuclear detonations;

(4) Radioactive material transportation as defined in this part;

(5) DOE activities conducted outside the United States on territory under the jurisdiction of a foreign government to the extent governed by occupational radiation protection requirements agreed to between the United States and the cognizant government;

835.1201 Sealed radioactive source control. 835.1202 Accountable sealed radioactive

sources.

Subpart N-Emergency Exposure Situations

or

835.1301 General provisions.
835.1302 Emergency exposure situations.
835.1303 (Reserved]
835.1304 Nuclear accident dosimetry.
APPENDIX A TO PART 835-DERIVED AIR CON-

CENTRATIONS (DAC) FOR CONTROLLING RA-
DIATION EXPOSURE TO WORKERS AT DOE

FACILITIES
APPENDIX B TO PART 835 (RESERVED)
APPENDIX C TO PART 835—DERIVED AIR CON-

CENTRATIONS (DAC) FOR WORKERS FROM
EXTERNAL EXPOSURE DURING IMMERSION

IN A CONTAMINATED ATMOSPHERIC CLOUD APPENDIX D TO PART 835_-SURFACE CONTAMI

NATION VALUES
APPENDIX E TO PART 835VALUES FOR ESTAB-

LISHING SEALED RADIOACTIVE SOURCE AC-
COUNTABILITY AND RADIOACTIVE MATERIAL

POSTING AND LABELING REQUIREMENTS
AUTHORITY: 42 U.S.C. 2201; 7191.

SOURCE: 58 FR 65485, Dec. 14, 1993, unless otherwise noted.

(6) Background radiation, radiation doses received as a patient for the purposes of medical diagnosis or therapy, or radiation doses received from participation as a subject in medical research programs.

(c) Occupational doses received as a result of excluded activities and radioactive material transportation, as listed in paragraphs (b)(1) through (b)(5) of this section, shall be considered when determining compliance with the occupational dose limits at $8 835.202 and 835.207, and with the limits for the embryo/fetus at $835.206. Occupational doses resulting from authorized emergency exposures and planned special exposures shall not be considered when determining compliance with the dose limits at $8 835.202 and 835.207. [58 FR 65485, Dec. 14, 1993, as amended at 63 FR 59679, Nov. 4, 1998]

Subpart A-General Provisions

$835.1 Scope.

(a) General. The rules in this part establish radiation protection standards, limits, and program requirements for protecting individuals from ionizing radiation resulting from the conduct of DOE activities.

(b) Exclusion. Except as discussed in paragraph (c) of this section, the requirements in this part do not apply to:

(1) Activities that are regulated through a license by the Nuclear Regulatory Commission or a State under an Agreement with the Nuclear Regulatory commission, including activities

8835.2 Definitions.

(a) As used in this part:

Accountable sealed radioactive source means a sealed radioactive source having a half-life equal to or greater than 30 days and an isotopic activity equal to or greater than the corresponding value provided in appendix E of this part.

Airborne radioactive material or airborne radioactivity means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

197-031 D-01--16

Airborne radioactivity area means any area, accessible to individuals, where:

(1) The concentration of airborne radioactivity, above natural background, exceeds or is likely to exceed the derived air concentration (DAC) values listed in appendix A or appendix C of this part; or

(2) An individual present in the area without respiratory protection could receive an intake exceeding 12 DAChours in a week.

ALARA means “As Low As is Reasonably Achievable,” which is the approach to radiation protection to manage and control exposures (both individual and collective) to the work force and to the general public to as low as is reasonable, taking into account social, technical, economic, practical, and public policy considerations. As used in this part, ALARA is not a dose limit but a process which has the objective of attaining doses as far below the applicable limits of this part as is reasonably achievable.

Annual limit on intake (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man (ICRP Publication 23) that would result in a committed effective dose equivalent of 5 rems (0.05 sievert) or a committed dose equivalent of 50 rems (0.5 sievert) to any individual organ or tissue. ALI values for intake by ingestion and inhalation of selected radionuclides are based on Table 1 of the U.S. Environmental Protection Agency's Federal Guidance Report No. 11, Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submersion, and Ingestion, published September 1988. This document is available from the National Technical Information Service, Springfield, VA.

Background means radiation from:

(i) Naturally occurring radioactive materials which have not been technologically enhanced;

(ii) Cosmic sources;

(iii) Global fallout as it exists in the environment (such as from the testing of nuclear explosive devices);

(iv) Radon and its progeny in concentrations or levels existing in buildings or the environment which have not been elevated as a result of current or prior activities; and

(v) Consumer products containing nominal amounts of radioactive material or producing nominal amounts of radiation.

Bioassay means the determination of kinds, quantities, or concentrations, and, in some cases, locations of radioactive material in the human body, whether by direct measurement or by analysis, and evaluation of radioactive materials excreted or removed from the human body.

Calibration means to adjust and/or determine either:

(i) The response or reading of an instrument relative to a standard (e.g., primary, secondary, or tertiary) or to a series of conventionally true values; or

(ii) The strength of a radiation source relative to a standard (e.g., primary, secondary, or tertiary) or conventionally true value.

Contamination area means any area, accessible to individuals, where removable surface contamination levels exceed or are likely to exceed the removable surface contamination values specified in appendix D of this part, but do not exceed 100 times those values.

Contractor means any entity under contract with the Department of Energy with the responsibility to perform activities at a DOE site or facility.

Controlled area means any area to which access is managed by or for DOE to protect individuals from exposure to radiation and/or radioactive material.

Declared pregnant worker means a woman who has voluntarily declared to her employer, in writing, her pregnancy for the purpose of being subject to the occupational dose limits to the embryo/fetus as provided at $835.206. This declaration may be revoked, in writing, at any time by the declared pregnant worker.

Derived air concentration (DAC) means, for the radionuclides listed in appendix A of this part, the airborne concentration that equals the ALI divided by the volume of air breathed by an average worker for a working year of 2000 hours (assuming a breathing

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