Issue Date: 12/22/08 1 84850 

NRC INSPECTION MANUAL FSME/DWMEP 

INSPECTION PROCEDURE 84850

RADIOACTIVE WASTE MANAGEMENT - INSPECTION OF WASTE 

GENERATOR REQUIREMENTS OF 10 CFR PART 20 AND 10 CFR PART 61 

PROGRAM APPLICABILITY: 2561, 2600 and 2800 

84850-01 INSPECTION OBJECTIVE 

To determine whether the licensee as a waste generator, in accordance with 10 CFR 

Part 20, Appendix G, has established and is maintaining adequate managementcontrolled procedures and quality assurance that reasonably ensure compliance with 

the requirements of 10 CFR Part 20 and 10 CFR Part 61 applicable to low-level 

radioactive waste form, classification, characterization, stabilization, and shipment 

manifests/tracking. 

84850-02 INSPECTION REQUIREMENTS 

02.01 Management Controls. Review the licensee's written procedures and 

documents for radioactive waste processing and disposal, specifically identifying the 

primary documentation thereof. Verify that the following aspects are adequately 

addressed: 

a. That the individual(s) and organizational entities that have been assigned the 

responsibility for radioactive waste processing for eventual land disposal per 10 

CFR Part 61 have been clearly designated in writing; 

b. That there has been a clear delineation of the authorities and responsibilities of 

those individuals and organizational entities; 

c. That written management-approved instructions have been established to carry 

out the various radioactive waste processing, disposal, and packaging activities, 

including authorized changes thereto, and the promulgation/distribution of such 

instructions to the appropriate line/staff organization. 

d. That there is an unambiguous procedure or process by which the licensee as a 

licensed processor or user of radioactive material becomes a “waste generator” 

in accordance with Appendix G of 10 CFR Part 20. 

02.02 Quality Assurance (QA). Verify that the licensee has established and maintains 

an adequate QA program to ensure compliance with the waste classification and 

characterization requirements of 10 CFR 61.55 and 61.56. Verify whether the QA 

program includes the required audits and management evaluation of such audits. 

Review the results of the most recent audit and corrective actions [Subsection III.A.3 of 

Appendix G to 10 CFR Part 20]. 

For nuclear power plant licensees, QA activities related to implementation of 10 CFR 

Part 61, 10 CFR 20.2006, and Appendix G to 10 CFR Part 20 are not required to be 
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included under the licensee's corporate level QA program for "Nuclear Safety Related" 

items. 

02.03 Waste Manifests. Review the licensee's procedures and records to verify that 

each shipment of radioactive waste, intended for eventual land disposal per 10 CFR 

Part 61, to a broker or a licensed land disposal facility is accompanied by a shipment 

manifest that includes all the required information [10 CFR 20.2006(b) and (c)]. 

02.04 Waste Classification. Review the licensee's documentation and records of 

activities that have been established and are being maintained, to ensure that all lowlevel radioactive wastes are properly classified according to 10 CFR 61.55. Verify 

whether such efforts reasonably assure that a realistic representation has been 

accomplished [Subsection III.A.1 of Appendix G to 10 CFR Part 20]. 

02.05 Waste Form and Characterization. Review the licensee's documentation and 

records of activities, which have been established and are being maintained, to ensure 

that all low-level radioactive waste meets the waste characteristics of 10 CFR 61.56. 

Verify whether the methods and determinations of the licensee provide reasonable

assurance that the waste form requirements are met [Subsection III.A.1 of Appendix G 

to 10 CFR Part 20]. 

02.06 Waste Shipment Labeling. Review the licensee's procedures and records to 

verify that each package of radioactive waste intended for shipment to a licensed land 

disposal facility is labeled, as appropriate, to identify it as Class A, B, or C waste in 

accordance with the classification criteria of 10 CFR 61.55 [10 CFR 61.57 and 

Subsection III.A.2 of Appendix G to 

10 CFR Part 20]. 

02.07 Tracking of Waste Shipments. Review the licensee's procedures and records, 

to verify that a system has been established to forward to recipients or deliver to waste 

collectors, at the time of shipment, a copy of the waste manifest. Verify that 

acknowledgment of receipt of the manifest is obtained. Verify that the licensee has a 

procedure in place to effect an investigation in any instances wherein acknowledgment 

of receipt of shipment has not been received within the specified period. Verify that 

procedures are in place to report such investigations to the appropriate U.S. Nuclear 

Regulatory Commission (NRC) Regional Office and file the required written report. 

[Subsection III of Appendix G to 10 CFR Part 20]. 

02.08 Disposal Site License Conditions. Review the licensee's procedures and 

records to verify that the applicable disposal site license conditions are being met. 

Verify that the licensee has on file current versions of applicable disposal site licenses. 

84850-03 INSPECTION GUIDANCE 

Guidance for inspectors as well as licensees has been provided by Low Level Waste 

Management Branch/Nuclear Material Safeguard and (NMSS) in the form of branch 

technical positions (BTPs) on "Waste Classification," dated May 1983 (see Federal 

Register, Vol. 48, No. 110, June 7, 1983), and "Waste Form," dated January 1991 (see 

Federal Register, Vol. 56, No. 18, January 28, 1991). In addition to the BTPs, NMSS 
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(antecedent of FSME) has stated publicly (48 FR 40512, Vol. 48, No. 175, September 8, 

1983) that "topical reports" of licensees that have been reviewed by NMSS may be 

useful in demonstrating compliance with the requirements. Inspectors should be aware 

of and may accept results referenced in such topical reports as demonstration of 

compliance in specific inspection cases. 

03.01 Specific Guidance

a. Inspection Requirement 02.01, Management Controls. Inspection effort should 

be directed at verifying that written procedures have been established in a 

manner approved by management. The procedures should be readily available 

to any persons having responsibility for low-level waste classification and 

preparation for transfer of such wastes to land disposal facilities or waste 

processors. The inspector should confirm that the written procedures include 

provisions for all of the applicable activities pertaining to Section 84850-02 

requirements. 

b. Inspection Requirement 02.02, Quality Assurance (QA). The written operating 

procedures and QA procedures of the licensee collectively are intended to 

accomplish compliance with the 10 CFR Part 20 and 10 CFR Part 61 regulatory 

requirements. The nature and scope of the licensee's QA program will vary 

depending on the nature and complexity of the specific waste stream. 

Inspectors should observe whether the program and procedures are effective in 

causing the licensee to perform the required waste form classification and 

characterizations when changes to the waste stream occur. Inspectors should 

also observe the records to verify they are legible, accurate, and complete 

throughout the specified retention period. 

c. Inspection Requirement 02.03, Waste Manifests. Inspectors should be aware 

that it is permissible for the licensee to use the same shipping paper documents 

that are required to meet U.S. Department of Transportation shipping paper and 

U.S. Environmental Protection Agency hazardous waste requirements, as the 

waste-manifest, provided that the combined documentation contains all of the 

information required by Appendix G to 10 CFR Part 20. Inspectors should 

ascertain that licensee is aware that additional waste manifest information may 

also be required by the operator of the land disposal facility. 

d. Inspection Requirement 02.04, Waste Classification. The inspector should 

review whether the method used by the licensee is adequate to determine 

radionuclide concentrations, in order to classify the waste. The BTP on waste 

classification describes four acceptable methods for classifying wastes. The 

inspector should use this BTP as the basic guidance in implementing this 

inspection requirement. 

1. For those licensees who use correlation factors for classifying wastes, 

correlation factors should be based on actual waste stream analysis. 

2. Generic pressurized water reactor, boiling-water reactor or facility scaling 

factors are acceptable if actual sample analysis data correlate with the 

generic data base. 
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3. If generic scaling factors are not appropriate for an individual waste 

stream, scaling factors should be based on the specific waste stream 

data. 

4. It is acceptable to base correlation factors on a single set of analyses, 

repeated annually. 

5. If sample analyses have not been completed, calculational methods for 

scaling factors are acceptable while analyses are in progress. Samples 

should be off site for analysis to be considered in progress. After receipt 

of the sample analyses, calculational methods may continue to be used 

provided the results correlate with the actual sample analyses. 

6. NRC-approved topical reports for waste classification are acceptable for 

demonstrating compliance with 10 CFR 61.55. 

e. Inspection Requirement 02.05, Waste Form and Characterization. The 

inspector should determine the test methods and acceptability of such tests 

used by the licensee to characterize his waste stream. In cases where a "high 

integrity container" is used to stabilize the waste, the type and acceptability of 

the specific container should be verified. The inspector should use the BTP on 

waste form as the basic guidance in implementing this inspection requirement. 

In addition: 

1. Classes B and C solidified waste programs should contain test data on 

compressive strength, leaching, irradiation stability, biodegradation, and 

thermal stability. Results of tests should be consistent with the BTP on 

waste form. Test data packages that do not address all of the above 

areas may be acceptable, provided that testing is under way to complete 

the data package. A schedule for completion of the testing should be 

available for NRC inspection. Solidification media currently being used 

must be consistent with disposal site license conditions. 

2. The licensee's solidification process control program should incorporate 

the testing information from the solidification agent stability qualification. 

3. NRC-approved topical reports on high integrity containers and 

solidification agents are acceptable for demonstrating compliance with 10 

CFR 61.56(b). 

4. A Certificate of Compliance issued by an Agreement State for a high 

integrity container is acceptable for demonstrating compliance for waste 

shipped to a licensed disposal facility in that State. 

f. Inspection Requirement 02.06, Waste Shipment Labeling. Inspectors as well as 

the licensee should be aware that Classes A, B, & C wastes bear no relationship 

to Types A or B packaging for transport purposes under 49 CFR Part 173 or 10 

CFR Part 71. The labeling of waste packages pursuant to this requirement is, 

therefore, in addition to any other package markings and labels required by the 

transport regulations. 

g. Inspection Requirement 02.07, Tracking of Waste Shipments. Inspectors 

should be aware of the differences in the requirements of Appendix G to 10 CFR 
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Part 20 on waste manifest tracking for shipments by generators to waste 

collectors, as opposed to shipments directly to land disposal facilities. There are 

also some differences in the specific requirements of a waste collector who 

processes the waste before shipping it to the disposal facility, as contrasted with 

a collector who simply stores the material before transferring it to the land 

disposal facility.

84850-04 REFERENCES 

04.01 Regulations

10 CFR Part 61 

10 CFR 20.1001 - 20.2402 

10 CFR Part 20 Appendix G 

04.02 Other References

Federal Register, Vol. 48, No. 110, June 7, 1983, NRC Notice, "Low-level Waste 

Licensing Branch Technical Position Papers on Radioactive Waste Classification and 

Waste Form; Availability." 

Federal Register, Vol. 56, No. 18, January 28, 1991, NRC Notice, "Staff Technical 

Position on Radioactive Waste Form; Availability." 

"Technical Position on Radioactive Waste Classification," mailed to all NRC licensees 

on May 11, 1983, by NMSS, Low-level Waste Management Branch. 

"Waste Form Technical Position Paper, Revision 1," mailed to all NRC licensees on 

January 24, 1991, by NMSS, Low-level Waste Management Branch. 

Federal Register, Vol. 48, No. 175, Sept. 8, 1983; NRC Notice "Topical Reports in 

Support of the Implementation of Waste Classification and Waste Form Requirements." 

END 
Issue Date: 12/22/08 Att1-1 

Attachment 1 

Revision History for 84850 

Commitment Tracking Number 

Issue Date Description of Change Training 

Needed 

Training Completion Date 

ComAcce

N/A 

12/22/08 CN 08-037 

Completed 4 year historical search and found no commitments. The revision changed document ownership to FSME, added a new management control, included minor modifications to allow flexibility in meeting disposal site requirements, and added a reference to 10 CFR Part 20 Appendix G. 

none 

 N/A ML0