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UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 June 17, 1991 Information Notice No. 91-39: COMPLIANCE WITH 10 CFR PART 21, "REPORTING OF DEFECTS AND NONCOMPLIANCE" Addressees: All Nuclear Regulatory Commission (NRC) material licensees. Purpose: The purpose of this notice is to remind licensees of the requirements contained in 10 CFR Part 21, "Reporting of Defects and Noncompliance" (Attachment 1). It is expected that licensees will review this information, distribute this notice to responsible staff, and consider actions, if appropriate, to ensure compliance with applicable requirements. However, this notice does not in itself establish any new requirements. Description of Circumstances: Past inspections at materials licensees indicate that many licensees are not complying with all the requirements of Part 21 and are unclear about the applicability of Part 21 to their licensed programs. In one case, a company supplying teletherapy units discovered a failure in a timer which could have resulted in a substantial safety hazard. Although the failure was evaluated and the timer was determined to require replacement, an evaluation to determine if a substantial safety hazard could exist was not performed. As a result, a responsible officer or director in the licensee's organization was not informed that the timer contained what NRC later determined to be a defect, and NRC was not notified of the defect, as required by 10 CFR 21.21(b). A contributing factor in this case was the failure to establish appropriate procedures to evaluate whether a deviation could represent a substantial safety hazard, as required by 10 CFR 21.21(a). In another case a radiographic equipment manufacturer reviewed circumstances surrounding separation of a source assembly from the drive cable. Although the licensee took actions to recall the defective source, it failed to report the defect to NRC and had not developed procedures for evaluating manufacturing defects, to determine applicability to Part 21 reporting. Discussion: Part 21 was issued in June 1977, and applies to all licensees and certain unlicensed vendors. The requirements in Part 21 are to ensure that equipment deficiencies or failures that could create a substantial safety hazard involving NRC-regulated activities are reported to NRC. Prompt licensee reporting of 9106110125 . IN 91-39 June 17, 1991 Page 2 of 3 defects will enable NRC to determine if a defect is generic in nature, so that appropriate measures can be taken to ensure protection of the public health and safety. The requirements are based on Section 206 of the Energy Reorganization Act, which states, in part, "Any individual director or responsible officer of a firm constructing, owning, operating, or supplying the components of any facility or activity which is licensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended, or pursuant to this Act, who obtains information reasonably indicating that such facility or activity or basic components supplied to such facility or activity (1) Fails to comply..., or (2) Contains a defect which could create a substantial safety hazard, ... shall immediately notify the Commission of such failure to comply, or of such defect...." The principal requirements of Part 21 include the following: (1) Licensees must post required documents related to Part 21 in a conspicuous location. These include a copy of the regulation, Section 206 of the Energy Reorganization Act of 1974, and any procedures developed pursuant to Part 21. [10 CFR 21.6(a) and (b)] (2) Licensees must develop procedures for identifying and evaluating deviations, or informing affected customers, so that the customer can evaluate the deviation; and must also develop procedures for reporting defects to a director or responsible officer. [10 CFR 21.21(a)] (3) Licensees must report defects to NRC, within certain time frames. [10 CFR 21.21(b)] (4) Procurement documents issued by the licensee for basic components must state that Part 21 applies to the procurement. [10 CFR 21.31] NRC staff recognizes that these requirements are very broad and require considerable licensee judgment to implement. As a minimum, licensees should determine which aspects of their licensed activity could result in a substantial safety hazard from a defect in a basic component. Attachment 2 provides guidelines for determining what constitutes a substantial safety hazard. NUREG-0302, Revision 1, published in October 1977, provides responses to questions on Part 21 raised in public regional meetings and contains several examples that will provide additional guidance on what constitutes a substantial safety hazard. Copies of NUREG-0302 may be purchased from the National Technical Information Service, Springfield, VA 22161. Furthermore, licensees are required to have procedures that implement the requirements to report defects. Procedures should assign responsibilities to the appropriate individuals, to identify and report deviations to responsible company officers. The responsibilities of company officers should be described; that is, to evaluate and report deviations to purchasers, and to inform NRC of defects within the required time frames. Licensees should evaluate their own programs and develop procedures appropriate for their activities. Attachment 3 provides a sample procedure for identifying and reporting defects, under Part 21. . IN 91-39 June 17, 1991 Page 3 of 3 Manufacturers or suppliers who provide licensees with basic components that contain, or are used with, radioactive material, would normally need more extensive procedures to ensure proper identification and reporting of defects than customers who do not supply components to others. These procedures should contain, as a minimum, the following: 1. Directions to acquire information sufficient to describe the deviation. 2. Directions to analyze the effect of the deviation, in a basic component, if used by a licensee. 3. Directions to reach a conclusion, based on the analysis as to whether the deviation could create a substantial safety hazard. Licensees are subject to inspection for compliance with Part 21, as well as other applicable NRC requirements, and may be subject to enforcement action for noncompliance. This information notice does not require any written response. If you have any questions about this matter, please contact the technical contact listed below or the appropriate NRC regional office. Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety Technical Contact: Cheryl A. Trottier, NMSS 301-492-3422 Attachments: 1. 10 CFR Part 21 2. Guidelines for Determining Whether a Substantial Safety Hazard Exists 3. Sample Procedure for Identifying and Reporting Defects Under 10 CFR Part 21 4. List of Recently Issued NMSS Information Notices 5. List of Recently Issued NRC Information Notices . Attachment 2 IN 91-39 June 17, 1991 Page 1 of 1 GUIDELINES FOR DETERMINING WHETHER A SUBSTANTIAL SAFETY HAZARD EXISTS 1. A substantial safety hazard means the loss of a safety function to the extent that there is a major reduction in the degree of protection provided to ensure public health and safety. Note that the term "public health and safety" includes both members of the public and licensee workers/employees. 2. From a radiological perspective, a substantial safety hazard exists if there is a potential for moderate exposure to, or release of, licensed material. a. Guidelines for determining moderate exposure: o Greater than 25 rem (whole body or its equivalent to other body parts) to occupationally exposed workers in a period of a year or less. o Exposure of 0.5 rem (whole body or its equivalent to other body parts) to an individual in an unrestricted area in a period of a year or less. b. Guideline for determining potential for release of licensed material: o Release of materials in amounts reportable under the provisions of 10 CFR 20.403(b)(2). For additional discussion, see NUREG-0302, Revision 1 (page 21.3(k)-1), which may be purchased from the National Technical Information Service, Springfield, VA 22161. . Attachment 3 IN 91-39 June 17, 1991 Page 1 of 1 SAMPLE PROCEDURE FOR IDENTIFYING AND REPORTING DEFECTS UNDER 10 CFR PART 21 Employees shall: 1. Identify deviations in a basic component (insert appropriate part or component nomenclature). 2. Promptly report the deviations to the responsible company officer or director (insert appropriate position). Company official (insert appropriate position) shall: 1. Cause deviation to be evaluated or reported to purchaser. 2. If determined to be a defect, promptly (within two days of receipt of information) inform the Nuclear Regulatory Commission (NRC). - By telephone, facsimile, or in writing to the Director, Office of Nuclear Material Safety and Safeguards, USNRC, Washington, DC 20555, or to the Regional Administrator. 3. If initial notification was by telephone or facsimile, a written report must be sent to NRC within 5 days of receipt of the information. Submit three copies. - Identify the basic component with the defect or activity that failed to comply. - Include the nature of the defect or failure and the safety hazard created or that could be created by the defect or failure. - Identify the date the information was obtained and the name of the individual informing NRC. - List all locations where the basic component may be in use. - Describe corrective actions taken or being taken. - Advice related to the defect that has been, or will be given to customers. .
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