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EPA Inspection Elements Applicable to Both Contact-Handled 

and Remote-Handled Transuranic Wastes 

This annotated outline presents the elements1

 for baseline inspections and Tier 1 (T1) evaluations 

for both contact-handled (CH) and remote-handled (RH) transuranic (TRU) wastes intended for 

disposal at the Waste Isolation Pilot Plant (WIPP). The elements common and unique to CH and 

RH TRU wastes are specified. The intended audience for this outline is the Department of 

Energy (DOE) Carlsbad Field Office (CBFO) and waste characterization personnel at TRU 

generator sites. The purpose is to delineate why EPA needs specific documents that EPA has 

consistently requested prior to and during previous inspections and T1 evaluations. The 

documents that EPA needs are those that support a waste characterization program’s 

demonstration of compliance with the requirements of 40 CFR 194.8 and 194.24. EPA expects to 

receive most of these documents with CBFO’s initial request for approval. EPA inspection 

personnel use this information to prepare for inspections and evaluations, i.e., to prepare 

checklists for assessing technical adequacy, identify inconsistencies or gaps in the available 

information, and formulate questions. The information extracted from these documents and from 

discussions with waste characterization personnel, in conjunction with other objective evidence 

collected during the inspection/evaluation, forms the basis for EPA’s approval decision. By 

providing this information in a complete and timely manner, DOE can receive approvals more 

quickly. 

The items identified in this outline represent the typical activities, procedures and processes that 

EPA evaluates during the course of a baseline inspection or T1 evaluation. However, this list is 

not comprehensive, nor does it necessarily represent all of the items that EPA will evaluate 

during a given inspection or T1 evaluation. As EPA inspection personnel proceed, additional 

documents and/or information may be necessary, as warranted by the specifics of the waste 

category, waste stream(s) or processes under evaluation. 

EPA verifies compliance with the upper tier requirements in 40 CFR 194.8 and 194.24. EPA 

does not directly evaluate TRU sites’ compliance with the DOE’s key documents, including the 

TRU Waste Acceptance Criteria (WAC) for CH, the Waste Characterization Program 

Implementation Plan (WCPIP) for RH, and other documents cited in the Compliance 

Recertification Application as evidence of a system of waste characterization controls. EPA uses 

these documents as evidence of DOE’s commitment to a system of controls and, in fact, during 

the course of evaluation of waste characterization activities, EPA may identify additional 

elements that require evaluation. For example, during the TI evaluation of an RH waste stream 

from the Idaho National Laboratory-Central Characterization Project (INL-CCP) in early 2010, 

information presented during the evaluation prompted EPA to schedule a site visit to Argonne 

National Laboratory (ANL) to observe sample collection and radiochemical analysis. EPA had 

not evaluated these aspects previously. 

This document covers the four key waste characterization elements that EPA evaluates for 

technical adequacy during a baseline inspection or T1 evaluation: 

 1

 Much of the information cited here was discussed during the April 2009 face-to-face 

meeting between EPA and CBFO staff at CBFO Headquarters in Carlsbad. 
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• Acceptable Knowledge (AK) for CH and RH 

• Non Destructive Examination (NDE), consisting of Real-Time Radiography (RTR), and 

Visual Examination (VE), typically for CH and RH 

• Non Destructive Assay (NDA), typically for CH 

• Radiological Characterization (RC) for RH 

EPA also verifies two other elements, the data tracking system (Waste Data System, formerly 

known as WWIS) and container management for CH and RH, but these are not included in this 

document. EPA does review implementing procedures for these activities on an as-needed basis 

and EPA has conducted announced and unannounced continued compliance inspections at 

specific TRU sites (CBFO, Los Alamos National Laboratory, INL, Oak Ridge National 

Laboratory) to evaluate these aspects. 

I. Acceptable Knowledge 

A. Waste Characterization Element Description 

As part of the inspection, EPA typically examines the following items noting that some 

documents are always applicable to each waste stream or Summary Category Group: 

• Waste stream identification and the definition, including radiological and physical 

content of the waste, and waste generating processes 

• Identification of HLW, TRU vs. LLW, SNF and defense status 

• Role of AK in the Characterization Methodology (e.g., NDA memorandum) 

• Compiling AK documentation and assembly of required information 

• Adequacy of the procedures used to implement the AK process (e.g., CCP-TP-005 and 

related attachments) 

• AK data traceability 

• AK source document sufficiency 

• AK verification or qualification pathway if AK is used to quantify parameters (RH only) 

• Certification Plan Preparation and adequacy (RH only) 

• Confirmatory Test Plan preparation and adequacy (RH only) 

• Characterization Reconciliation Report preparation and adequacy (RH only) 

• Correlation and Surrogate Summary Form and CH-RH correlation (RH only) 

• Waste Stream Profile Form preparation and contents, including applicable elements of 

the Characterization Information Summary and Summation of Aspects 

• Personnel Training 
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• NCRs and AK Discrepancy Resolution 

• AK Accuracy 

• Load Management 

• Identification of DQO determination method including those to be qualified by AK (RH 

only) 

• DQOs attained through AK Qualification (RH only) 

• NDA-AK communication (typically CH only, per the NDA memorandum) 

B. Documents and Other Information Reviewed

When a request for approval is made, EPA asks for numerous technical documents pertinent to 

the inspection, which EPA must have at least one-month before the inspection. EPA, however, 

recognizes that some may be only available at the beginning of the inspection. This information 

includes, but is not limited to: 

• AK Summary Report (AKSR), including the 500 and 501 documents for RH 

• Relevant procedures (e.g., CCP-TP-005) 

• Certification Plan (including those for RH waste as defined in the WCPIP, e.g., 502 series 

documents) 

• Source documents (as referenced in the AKSR) 

• All CCP-TP-005 attachments (excluding Attachment 5) including the AK-NDA 

memorandum for CH 

• All WCPIP-specified information including, but not limited to, the Correlation and 

Surrogate Summary Form (CSSF), Characterization Reconciliation Reports (CRR) 

(typically part of the WSPF), Certification Plan, all Sampling/Analysis Plans, Test Plans, 

etc. 

• Waste Stream Profile Forms (WSPF) and all attachments including the Characterization 

Information Summary and Summation of Aspects 

• Listing of all available/fully characterized drums and respective batch data reports 

(BDRs) typically available in the CRR, CIS, 

• BDRs (summary results only for radiological and VE/RTR) 

• AK Accuracy Reports 

• Training Records for AK Experts (AKE) and site project managers (SPM) 

• Traceability information, noting that some may not be in source documents 

• Discrepancy Resolution/NCRs (examples, noting that these are also source documents 

and may be contained in BDRs) 

• QA Equivalency Document (RH) 
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C. Technical Evaluation

The following AK technical elements are examined by EPA during a typical baseline inspection 

or T1 evaluation.2

 Each EPA inspection report typically discusses EPA’s evaluation of the 

elements listed below; elements are evaluated for technical adequacy and EPA’s report cites 

objective evidence examined including source documents, inspection interview results, and other 

information. This listing is a starting point, and items are typically added or removed as a result 

of the pre-inspection review process or during the inspection. For example, addition of 

containers to an approved waste stream may require less analysis than evaluation of a full CH 

Summary Category Group (SCG) or a baseline request. The elements below are not listed by 

priority but are included to indicate how EPA inspectors proceed with an AK evaluation. For this 

examination, EPA relies on the AK AKSR3

 and expects it to contain detailed narration and 

sufficient references to demonstrate that the waste is WIPP-eligible, including adequate waste 

stream determinations, sufficient discussion of physical/radiological characteristics, and 

complete analysis of the presence of SNF, HLW, and waste defense status. 

1. Waste Stream identification and justification (RH and CH): Depending on the waste type 

(RH or CH), EPA determines whether the waste category and waste streams have been 

appropriately defined. This examination includes a review of processes, which resulted in the 

generation of waste and how the waste is managed (segregated versus non-segregated). The 

review also includes physical form analysis and detailed radiological information. The waste 

stream definitions for RH and CH waste are presented in the WCPIP, WAC, and WAC. 

2. The identification of High-Level Waste, Spent Nuclear Fuel, and the waste’s defense 

determination (RH and CH): A TRU generator site must succinctly describe in AKSR why 

the given waste is not HLW, SNL, and has a defense pedigree. The DOE is fully 

responsible for making this determination with a site-specific well documented 

supporting rationale.

3. Sufficiency of the AKSR (RH and CH): The AKSR has a specified content in CCP-TP-005, 

and EPA evaluates whether the AKSR follows that outline. Additionally, both RH and CH 

AKSRs are examined to determine whether the arguments therein are complete and 

technically adequate, and to ensure that sample source documents cited support the AKSR.

 2

 When preparing for EPA inspections, it is recommended that CBFO/CCP/TRU 

generator sites refer to the previously-issued site-specific inspection reports for the types of 

documents EPA typically requires for evaluation, recognizing that site-specific documents, such 

as Sampling Reports, are also required. 

3

 EPA considers the AKSR to be a key summary document describing the waste. EPA 

recognizes that the AKSR is used by site waste characterization personnel; however, that does 

not justify a lack of details or insufficient referencing in the AKSR. To address EPA’s concern 

about the lack of details, a TRU generator site could include relevant details in appendices and 

appropriately identified in the AKSR sections. 
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4. Implementation of the associated AK Procedure (RH and CH), typically CCP-TP-005: EPA 

examines the overall AK data acquisition, assembly, review, and re-evaluation processes, 

including preparation of NCRs and DRs (see No. 14 below). 

5. Data traceability including data management (RH and CH): Drum traceability from original 

generator paperwork through BDR development and drum tracking in the IDC and WDS is 

examined, and may include CCP-specific data management tools. 

6. Sufficiency of AK Support Documents including data limitations and exclusions (RH and 

CH) by taking a sample of supporting documents for relevancy to the AKSR and to 

determine whether all of the necessary AK support documents have been assembled. 

7. Document Tracking (RH and CH): The AK Record, as presented in the waste stream-specific 

and overall AK reference list, is examined for completeness. 

8. The Certification Plan and Confirmatory Test Plan are evaluated for technical content (RH 

only). 

• The Certification Plan and CTP are evaluated to determine whether the required contents 

are included, the clarity of the information provided and technical adequacy of the 

documents. 

• A description of how the tested subpopulation will be representative of the waste stream 

or waste stream lot. 

 

9. Content and technical adequacy of the CRR (RH only): CCP-TP-506, Rev. 1, CCP 

Preparation of the Remote-Handled Transuranic Waste Acceptable Knowledge 

Characterization Reconciliation Report, specifies contents of the CRR. The CRR Report is 

typically evaluated to determine the completeness and adequacy of its contents. 

10. Use of a Correlation and Surrogate Summary Form (CSSF) (RH only): Contents of the CSSF 

are evaluated for content and relevance to the waste stream. 

11. Review of personnel training records (RH and CH) of AKEs and SPM to determine whether 

the training covers EPA requirements and is up to date and addresses the subject 

streams/topical matter. 

12. Sufficiency and completeness of the Radiological Characterization portion of the AKSR (RH 

and CH): EPA examines the AKSR to confirm that the radiological information presented 

ensures that the data support the waste stream designation and provides a reasonable 

representation of the radiological composition of the waste stream, including overall 

radionuclide composition (mass and activity), as well as the general isotopic distribution of 

the 10 EPA WIPP-tracked radionuclides and other radionuclides, as applicable. AK 

radiological data are also presented in the RH Radiological Characterization Report, which is 

examined to ensure consistency with the AKSR and the inclusion of necessary radionuclide 

information. 
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13. Site-specific waste evaluation or characterization methods, such as Confirmatory Testing 

Plans, Sampling Plans, or Sampling Reports/memorandum (RH and CH): Confirmatory Test 

Plans or Sampling and Analysis plans or other documents are sometimes prepared to support 

the waste stream characterization processes. “Fast Scan” (both RTR and VE) may also be 

evaluated, depending upon site-specific conditions. The sampling and analysis plans are 

examined separately for completeness and technical adequacy. 

14. NCRs and Discrepancy Resolution Forms (RH and CH): These elements may be evaluated as 

part of other characterization review activities (e.g., RTR, VE, and NDA). 

15. The Waste Stream Profile Form (RH and CH): WSPFs are examined for completeness and to 

be sure they agree with AK information; forms are also examined to be sure they include 

required attachments (e.g., CRR and CIS). 

16. AK Accuracy (RH and CH): The content of the AK accuracy report is assessed in three 

areas: reassignment of the waste to a different SCG, reassignment of the waste to a 

different waste stream, and waste stream-specific assessment of radiological parameter 

accuracy. 

17. Physical characteristics of the waste including the presence of liquids/prohibited items (RH 

and CH): Physical characteristics of the waste stream are evaluated with the SCG, but the 

composition of the waste stream with respect to individual components and general 

percentages (mass or volume) is also important to the waste stream designation. Data 

presented in the AKSR (including tables and supporting Attachments/memoranda) are 

evaluated. 

18. Load Management (RH and CH). 

19. NDA-AK communication (CH only, although the 501 series documents are an 

important demonstration of this element in the RH program) through examination of 

the AK-NDA memorandum. This communication is key to the AK and NDA personnel 

having similar understanding (full disclosure) of the waste. 

20. AK Qualification Method identification for each DQO (RH only): The Certification 

Plan presents this information. 

21. Attainment of DQOs: EPA assesses how each DQO is addressed including the correct 

identification of waste streams. The following DQOs are presented in the WCPIP: 

• Defense, HLW, and SNF determination 

• TRU waste determination 

• RH waste determination 

• Activity determination (total and activity per canister, including quantification and 

identification of the 10 EPA WIPP-tracked radionuclides) 
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• Liquids

• Physical Form, including metals and CPR 

II. Non Destructive Examination – Real-Time Radiography and Visual Examination 

The following elements are evaluated during each inspection or T1 evaluation for both CH and 

RH wastes. Some sites require site-specific inspection elements, but these are documented in the 

individual inspection reports.4 Each EPA inspection report discusses EPA’s evaluation of the 

elements listed below; elements evaluated for technical adequacy and EPA’s report cite objective 

evidence examined including source documents, inspection interview results, and other 

information. This listing is a starting point, and items are typically added or removed as a result 

of the pre-inspection review process or during the inspection. 

Real Time Radiography (RTR) 

A. Waste Characterization Element Description 

This section lists the reason each technical area is inspected. 

B. Documents and Other Information Reviewed

A list of documents, written BDRs, audio/visual recordings, and records reviewed during the 

inspection is provided. 

C. Technical Evaluation

1. Overall procedural adequacy and implementation: The Standard Operating Procedures 

(SOPs) used to perform RTR are reviewed to ensure they are complete and adequate. 

Implementation of each SOP is verified by review of records, and BDRs are reviewed in 

conjunction with other pertinent documents such as work instructions and Non Conformance 

Reports (NCRs). 

2. Characterization of WMPs and prohibited items: All types of records are reviewed and, 

whenever possible, an RTR event is observed. A description of the RTR process is provided 

in this section. Whenever possible, a demonstration is observed to verify set up of equipment, 

identification of WMPs and assignment of WMP weights. Operators are interviewed as 

necessary. 

3. Documentation of radiography activities: Comparison of written and audio/visual records 

reviewed to ensure consistency. 

 4

 When preparing for EPA inspections/T1 evaluations, it is recommended that 

CBFO/CCP/TRU generator sites refer to the site-specific inspection reports for the types of 

documents EPA typically requires for evaluation, recognizing that site-specific documents may 

be required. 
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4. Adequate documentation of procedures and processes: BDRs are examined to ensure 

complete records and NCRs are reviewed; consistent review of RTR data is determined. 

5. Training of personnel: Both written and audio/visual training records are reviewed to ensure 

that they are current and only qualified operators perform the examinations. Packaging 

records for the training drums are evaluated against the items identified by the operators. 

Visual Examination and (VE)

A. Waste Characterization Element Description

This section lists the reason each technical area is inspected. 

B. Documents and Other Information Reviewed

 

A list of documents, BDRs, and records reviewed during the inspection is provided. 

C. Technical Evaluation

1. Overall procedural adequacy and implementation: The SOP(s) used to perform VE are 

reviewed to ensure they are complete and adequate. Implementation of the SOP(s) is verified 

by review of records. BDRs are reviewed in conjunction with other pertinent documents such 

as work instructions and NCR forms. 

2. Characterization of WMPs and prohibited items: All types of records are reviewed and, 

whenever possible, a VE event is observed. A description of the VE process is provided in 

this section. During the demonstration, EPA verifies the correct assignment of WMPs and 

their estimated or actual weights. Operators are interviewed as necessary. 

3. Documentation of VE activities: Comparison of written and/or audio/visual records reviewed 

if such recordings are available. Written records are reviewed if the VE event was performed 

by 2 operators. 

4. Adequate documentation of procedures and processes: BDRs are examined to ensure 

complete records and NCRs are reviewed. Consistent review of VE data is determined 

5. Training of personnel: Training records are reviewed to ensure that only qualified individuals 

generate and review VE data. Training material is occasionally reviewed to verify content. 

Appointment records for VEEs are reviewed to ensure only qualified personnel are 

designated to fulfill this function. 

III. Non Destructive Assay – CH TRU Wastes 

A. Waste Characterization Element Description
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As part of the inspection, EPA typically examines the following items: 

• System design and history 

• Reports that document the system’s calibration, calibration verification and calibration 

confirmation, as appropriate 

• Applicability of the system’s calibrated/operational range for typical wastes, i.e., with 

respect to matrix, radionuclide content (type and concentration), and the ability of system 

to provide activity and uncertainty values for the 10 WIPP-tracked radionuclides 

• Ability of system to meet measurement DQOs for Lower Limit of Detection (LLD), and 

discrimination of TRU versus Non-TRU materials 

• Technical basis and documentation of the system’s Total Measurement Uncertainty 

(TMU) 

• Training of NDA operational and data reduction personnel 

• Documentation of performance testing in NDA Batch Data Reports (BDRs), equipment 

log books or other formats, as appropriate 

This section lists the reason each technical area is inspected. 

B. Documents and Other Information Reviewed

A list of documents and records reviewed during the inspection is provided. 

C. Technical Evaluation

The following aspects of each NDA system within the scope of an inspection or T1 evaluation 

are assessed—two separate but related aspects, namely, the technical merits of the activities that 

support the radionuclide values produced by each system, and the ability of the available records 

to document these operations. 

1. The design and operational range of each NDA system within the scope: For multi-modal 

systems this must be assessed for each operational mode, e.g., integrated gamma-neutron 

systems and passive active neutron systems. This includes the system’s ability to identify and 

quantify the 10 WIPP-tracked radionuclides, provide unbiased values for other radionuclides 

important to waste isolation and the suitability of the system for range of matrices, nuclear 

material types and content. 

2. Each system’s calibration, calibration confirmation and calibration verification, as 

appropriate: This varies, depending on the system’s approval history with EPA and 

operating history, and includes an evaluation of the radionuclide and matrix standards used 

for all calibration-related activities. 
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3. Each system’s performance indicators, e.g., radionuclide performance checks, background 

determinations and weekly interfering matrix checks; ability of each NDA system to attain 

the appropriate data quality objectives. 

4. Training for all NDA personnel (including data reduction and validation) and the adequacy 

of written procedures to technically support NDA data. 

5. Batch data reports (BDRs) that document the results of the NDA systems, including evidence 

of all system performance and background checks. 

6. The total measurement uncertainty (TMU) of each NDA system within the activity’s scope. 

7. The system’s lower limit of detection (LLD), including each system’s ability to make 

TRU/Non TRU distinctions at concentrations of TRU radionuclides at 100 nCi/g. 

8. The status of each system with respect to participation in the CBFO-sponsored Performance 

Demonstration Program (PDP).

9. EPA replicate testing with respect to the EPA Replicate Testing Protocol, as deemed 

appropriate by EPA to assess the system’s precision.

IV. Radiological Characterization – RH TRU Wastes 

A. Waste Characterization Element Description

The technical adequacy of the radiological characterization processes that EPA observed initially 

depended largely on the development and application of radionuclide scaling factors that 

correlate a waste container’s external exposure (dose) rate with isotopic distributions for specific 

TRU radionuclides, Dose-to-Curie or DTC. In some cases, the scaling factors were developed or 

supported by the use of radiometric data from destructive or nondestructive testing at DOE 

laboratories at INL and ANL, or ancillary measurement techniques such as the OSPREY or the 

In Situ Object Counting System (ISOCS). More recent RH waste streams have used other 

techniques such as weight and length measurements, coupled with the application of the wastespecific radionuclide information (ANL AGHCF or K-Wing FEW). The specific manner in 

which these correlations are developed varies, and it is instructive to outline the characterization 

process, as shown below. 

B. Documents and Other Information Reviewed

The list provided below includes the general types of documents that EPA evaluates for RH TRU 

wastes. 

• CCP-AK-XXXX-5X1, Central Characterization Project Remote-Handled Radiological 

Characterization Technical Report For Remote-Handled Transuranic Waste From the 

Specific Site; current revision 
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• CCP-AK-XXXX-5X0, Central Characterization Project Acceptable Knowledge 

Summary Report For Specific Site; current revision 

• CCP-AK-XXXX-5X2, Central Characterization Project RH TRU Waste Certification 

Plan for 40 CFR Part 194 Compliance and Confirmation Test Plan for Specific; current 

revision 

• CCP-TP-504, CCP Dose-To-Curie Survey Procedure for Remote-Handled Transuranic 

Waste; current revision 

• DTC BDRs, or equivalent documentation 

• Calculation packages, as applicable, typically numbered XXXX-RH-01 through XXXRH-XX 

• Documents that support other aspects of radiological characterization, e.g. laboratory 

qualifications, procedures, reports, data packages, instrument calibrations or performance 

testing) 

C. Technical Evaluation

The following technical elements are examined by EPA during a typical baseline inspection or 

T1 evaluation. This listing is a starting point, and bullets or items are typically added or removed 

as a result of the pre-inspection review process or during the inspection. These elements are not 

listed by priority.

1. The technical adequacy and documentation of radionuclide inventory or other historical data 

to support radiological characterization.

2. Data obtained from the application of a measurement technique that supports radiological 

characterization (radiochemical, NDA, mass spectrometry, ICPMS, ISOCS) are evaluated, 

including an evaluation of the technique’s technical basis and regulatory status, including 

ancillary documents. 

3. Data obtained from the application of other techniques that support radiological 

characterization (length or mass determination) are evaluated, including the technique’s 

technical basis and regulatory status and ancillary documents. 

4. The development of radionuclide scaling factors is evaluated, including the application of 

modeling (ORIGEN, MCNP, Microshield®) or other techniques. 

5. Training for all radiological characterization personnel (including data reduction and 

validation) and the adequacy of written procedures to technically support radionuclide data 

are evaluated. 

6. The technical basis of the Dose-to-Curie (DTC) correlation is evaluated, if applicable, or the 

applicable alternate technique. 
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7. Other technical aspects and documentation of the radiological characterization process are 

evaluated, including attainment of appropriate DQOs. 

8. The technical basis, derivation and documentation of TMU are evaluated. 

9. Documentation for WIPP-tracked radionuclides in DTC BRDs (or equivalent documentation) 

is assessed. 

10. RH and TRU determinations are evaluated.