Issue Date: 09/11/08 1 78010 

 NRC INSPECTION MANUAL HLWRS 

INSPECTION PROCEDURE 78010 

10 CFR PART 21 PROGRAM 

PROGRAM APPLICABILITY: 2300 

78010-01 INSPECTION OBJECTIVE 

To verify that the U.S. Department of Energy, as an applicant for, or holder of, a 

construction authorization or license to receive and possess source, special nuclear, or 

byproduct material under Title 10 of the Code of Federal Regulations (10 CFR) Part 63, 

“Disposal of High-level Radioactive Wastes in a Geologic Repository at Yucca 

Mountain, Nevada,” and suppliers of basic components for Part 63 facilities and 

activities (hereafter referred to collectively as “entity”) have established a program and 

procedures to effectively implement 10 CFR Part 21, “Reporting of Defects and 

Noncompliance,” requirements for reporting defects and failures to comply associated 

with substantial safety hazards (SSHs). 

78010-02 INSPECTION REQUIREMENTS 

02.01 Verify that the entity has implemented the requirements of 10 CFR 21.21(a) for 

evaluating deviations and failures to comply. 

02.02 Verify that the entity has implemented the requirements of 10 CFR 21.21(b) for 

notifying purchasers or affected licensees of deviations and failures to comply. 

02.03 Verify that the entity has implemented the requirements of 10 CFR 21.21(d) 

for notifying the U.S. Nuclear Regulatory Commission (NRC) of identified defects or 

failures to comply associated with SSHs. 

02.04 Verify that the entity has implemented the requirements of 10 CFR 21.31 

regarding specifying the applicability of Part 21 in procurement documents for basic 

components. 

02.05 Verify that the entity has implemented the requirements of 10 CFR 21.51 

regarding maintenance of records. 

02.06 Verify that the entity has implemented the posting requirements of 10 CFR 21.6. 

78010-03 INSPECTION GUIDANCE 

03.01 Verify controls are in place for the evaluation of deviations and failures to comply 
Issue Date: 09/11/08 2 78010 

as required in 10 CFR 21.21(a) by performing the following: 

a. Verify that the entity has adopted procedures to evaluate deviations and failures 

to comply that provide for the following: 

 1. Measures to evaluate a deviation or failure to comply as soon as 

practicable, and in all cases within 60 days of discovery, in order to 

identify a reportable defect or failure to comply that could create an SSH if 

it were to remain uncorrected. 

 2. If the evaluation cannot be completed within 60 days from discovery, 

measures to ensure that an interim report is submitted to the Commission 

within 60 days of discovery. The interim report should describe the 

deviation or failure to comply being evaluated and should state when the 

evaluation will be completed. 

 3. A director or responsible officer is informed of a defect or failure to comply 

associated with an SSH as soon as practicable, and in all cases, within 5 

working days after completion of the evaluation. 

 b. Verify that the quality assurance processes to control nonconformances and 

corrective actions provide a direct connection to the Part 21 program and 

procedures. 

 c. Select a sample of evaluated deviations that did not result in the identification of 

a defect or failure to comply and verify that: 

 1. The item was identified for evaluation consistent with established 

procedures. 

 2. The information and data used in the evaluation is clearly documented 

and complete. 

 3. The finding of the evaluation that an SSH does not exist is a logical 

conclusion of the evaluation. 

03.02 Verify that an entity supplying basic components has implemented the 

requirements of 10 CFR 21.21(b) for notifying purchasers or affected licensees of 

deviations and failures to comply if the entity determines it does not have the capability 

to perform the 10 CFR 21.21(a)(1) evaluation. Verify that measures are in place by 

performing the following: 

 a. Verify the entity has established directions to inform all affected (or potentially 

affected) licensees or purchasers within 5 days. 

 b. Select a sample of identified deviations and failures to comply for which the 

entity was not capable of performing a 10 CFR 21.21(a)(1) evaluation and verify 

that: 
Issue Date: 09/11/08 3 78010 

 1. The item was identified for evaluation consistent with established 

procedures. 

 2. The entity identified and informed all affected (or potentially affected) 

purchasers or licensees within 5 days from the determination. 

03.03 Verify that the entity has implemented the requirements of 10 CFR 21.21(d) for 

notifying NRC of identified defects or failures to comply associated with SSHs by 

performing the following: 

 a. Verify that the entity’s program and procedures provide that a director or 

responsible officer or designee will notify the Commission when he or she 

obtains information reasonably indicating a defect or failure to comply. 

 b. Verify that the entity’s program and procedures reflect the processes and time 

frames for reporting identified defects or failures to comply as follows: 

 1. An initial notification is prepared and submitted by facsimile or by 

telephone to the Commission within 2 days of the receipt of information by 

the director or responsible officer of the identification of a defect or failure 

to comply. 

 2. A written notification is prepared and submitted to the Commission within 

30 days of the receipt of information by the director or responsible officer 

of the identification of a defect or failure to comply. 

 c. Verify that the entity’s program and procedures provide that the written 

notification of a defect or failure to comply includes the following information: 

 1. Name and address of individual informing the Commission. 

 2. Identification of basic component which contains the defect or fails to 

comply. 

 3. Identification of the entity supplying the basic component. 

 4. Nature of the defect or failure to comply and the SSH that could be or was 

created by the defect or failure to comply. 

 5. The date on which the information of the defect or failure to comply was 

obtained. 

 6. The number and location of all such basic components in use at the 

facilities subject to this regulation. 

 7. The corrective action taken. 
Issue Date: 09/11/08 4 78010 

 8. Name of individual responsible for the action. 

 9. Length of time to complete the action. 

 d. Select a sample of records in which the director or responsible officer notified 

the Commission of a defect or failure to comply and verify the timeliness and 

completeness of such notification consistent with the guidance in subsections 

03.03(b) and 03.03(c), respectively, of this inspection procedure. 

03.04 Verify the implementation of procurement document controls as required in 

10 CFR 21.31 by selecting a sample of procurement documents for basic components 

and verifying that each procurement document specifies the applicability of Part 21. 

03.05 Verify the implementation of records control as required in 10 CFR 21.51 by 

verifying that the entity has procedures and controls in place that provide for the 

following: 

 a. Evaluations of all deviations and failures to comply are retained for a minimum 

of 5 years after the date of the evaluation. 

 b. Entities supplying basic components retain any notifications sent to purchasers 

and affected licensees for a minimum of 5 years after the date of the notification. 

 c. Entities supplying basic components retain a record of the purchasers of basic 

components for 10 years after delivery of the basic component or service 

associated with a basic component. 

03.06 Verify compliance with the posting requirements of 10 CFR 21.6 by selecting at 

least one posting location for inspection and verifying the following: 

 a. The following information as required in 10 CFR 21.6(a) is posted in a 

conspicuous location where activities subject to Part 21 are conducted: 

 1. Section 206 of the Energy Reorganization Act of 1974, 

 2. The current version of Part 21, and 

 3. The entity’s procedures that implement the regulations in Part 21. 

 b. If posting in accordance with 10 CFR 21.6(a) is not practicable, the following 

information as required in 10 CFR 21.6(b) is posted: 

 1. Section 206 of the Energy Reorganization Act of 1974, 

 2. A notice containing the following: 

 (a) A description of Part 21 and the procedures that implement the 

regulation, 
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 (b) The name of the individual to whom Part 21 reports may be made, 

and 

 (c) The location where the Part 21 regulations and implementing 

procedures may be examined. 

78010-04 RESOURCE ESTIMATE 

Inspection resources necessary to complete this inspection procedure are estimated to 

be 40 hours of direct inspection effort. 

78010-05 REFERENCES 

U.S. Code of Federal Regulations. 10 CFR Part 21, “Reporting of Defects and 

Noncompliance.” 

U.S. Code of Federal Regulations. 10 CFR Part 63, “Disposal of High-level Radioactive 

Wastes in a Geologic Repository at Yucca Mountain, Nevada” 

END
Issue Date: 09/11/08 Att1-1 

Attachment 1 – Revision History for IP 78010 

Commitment 

Tracking 

Number 

Issue Date Description of Change Training 

Required 

Training 

Completion 

Date 

Co

Ac

N/A 09/11/08 

CN 08-026 

Initial issuance of IP 78010. Issued to support inspections described in IMC 2300, “Yucca Mountain Inspection Program: License Application Review Period.” Researched commitments for 4 years and found none 

N/A N/A ML0