1 EPA Inspection Elements Applicab le to Both Contact-Handled

and Remote-Handled Transuranic Wastes

This annotated outline presents the elements 1 for baseline inspections a nd 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 (W IPP). The elements common and unique to CH and RH TRU wastes are specified. The intended audi ence for this outline is the Department of Energy (DOE) Carlsbad Field Office (CBFO) and waste char acterization 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 inspec tions and T1 evaluations. The

documents that EPA needs are those that support a waste charac terization program’s demonstration of compliance with the requi rements 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, identi fy inconsistencies or gaps in the available information, and formulate questions. The informa tion extracted from these documents and from

discussions with waste characte rization 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 ti mely 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 eval uation. However, this list is not comprehensive, nor does it necessarily repres ent 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 ti er requirements in 40 CFR 194.8 and 194.24. EPA does not directly evaluate TRU sites’ complia nce with the DOE’s key documents, including the TRU Waste Acceptance Criteri a (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 characteriza tion 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 characteri zation activities, EPA may identify additional elements that require evaluation. For example, dur ing the TI evaluation of an RH waste stream from the Idaho National Laboratory-Central Ch aracterization Project (INL-CCP) in early 2010, information presented during the evaluation prom pted EPA to schedule a site visit to Argonne National Laboratory (ANL) to observe sample co llection and radiochemi cal analysis. EPA had not evaluated these aspects previously.

This document covers the four key waste characterization elem ents that EPA evaluates for technical adequacy during a baseline inspection or T1 evaluation:

1 Much of the information cited here was discussed during the Ap ril 2009 face-to-face meeting between EPA and CBFO staff at CBFO Headquarters in Carlsbad.2 • Acceptable Knowledge (AK) for CH and RH

• Non Destructive Examination (NDE), consis ting of Real-Time Ra diography (RTR), and Visual Examination (VE), t ypically for CH and RH

• Non Destructive Assay (NDA), typically for CH

• Radiological Characteriz ation (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 procedur es 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 Nati onal Laboratory, INL, Oak Ridge National Laboratory) to evaluate these aspects.

I. Acceptable Knowledge

A. Waste Characterization Element Description

As part of the inspection, EP A typically examines the following items noting that some documents are always applicab le to each waste stream or Summary Category Group:

• Waste stream identification and the defi nition, 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 Characteriza tion 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 Prepara tion and adequacy (RH only)

• Confirmatory Test Plan prepar ation and adequacy (RH only)

• Characterization Reconcilia tion Report preparation and adequacy (RH only)

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

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

the Characterization Information Su mmary and Summation of Aspects

• Personnel Training3 • 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 Qu alification (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 wa ste 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 includi ng, but not limited to, the Correlation and Surrogate Summary Form (CSSF), Character ization Reconcilia tion Reports (CRR) (typically part of the WSPF), Ce rtification 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 characterize d drums and respective batch data reports (BDRs) typically availa ble 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 so me may not be in source documents

• Discrepancy Resolution/NCRs (examples, notin g that these are also source documents and may be contained in BDRs)

• QA Equivalency Document (RH)4 

## C. Technical Evaluation

The following AK technical elements are examin ed 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 docume nts, inspection interview results, and other information. This listing is a star ting point, and items are typically added or removed as a result of the pre-inspection review process or during the inspecti on. For example, addition of containers to an approved waste stream may re quire 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 i ndicate how EPA inspectors proceed with an AK evaluation. For this examination, EPA relies on the AK AKSR 3 and expects it to contai n detailed narration and

sufficient references to demonstrate that the wa ste is WIPP-eligible, including adequate waste stream determinations, sufficient discussion of physical/radiologica l characteristics, and complete analysis of the presence of SNF, HLW, and wast e defense status.

1. Waste Stream identification and justificati on (RH and CH): Dependi ng on the waste type (RH or CH), EPA determines whether the wa ste 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 mana ged (segregated versus non-segregated). The review also includes physical form analysis a nd 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, Sp ent Nuclear Fuel, and the waste’s defense determination (RH and CH): A TRU generator site must succi nctly describe in AKSR why the given waste is not HLW, SNL, and has a defense pedigree. The DOE is fully responsible for making this determinatio n 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 prev iously-issued site-specific insp ection 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 wa ste characterization pers onnel; 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 rele vant details in appendices and appropriately identified in the AKSR sections.5 4. Implementation of the associated AK Procedur e (RH and CH), typically CCP-TP-005: EPA examines the overall AK data acquisition, asse mbly, 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 Docu ments including data limitati ons and exclusions (RH and CH) by taking a sample of supporting documen ts 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 informati on provided and technical adequacy of the

documents.

• A description of how the tested subpopulation will be represen tative 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 Tr ansuranic Waste Acceptable Knowledge Characterization Reconciliation Report, specifies contents of the CRR. The CRR Report is typically evaluated to determine the comp leteness and adequacy of its contents.

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

are evaluated for content and relevance to the waste stream.

11. Review of personnel training r ecords (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 Radiologica l 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 radiol ogical composition of the wa ste stream, including overall radionuclide composition (mass and activity), as we ll as the general isotopic distribution of

the 10 EPA WIPP-tracked radionuclides a nd other radionuclides, as applicable. AK radiological data are also pres ented in the RH Radiological Ch aracterization Report, which is examined to ensure consistency with the AKS R and the inclusion of necessary radionuclide

information.6 13. Site-specific waste evaluation or characterization methods, su ch as Confirmatory Testing Plans, Sampling Plans, or Sampling Reports/m emorandum (RH and CH): Confirmatory Test Plans or Sampling and Analysis plans or othe r documents are sometimes prepared to support the waste stream characterization processes. “Fast Scan” (both RTR and VE) may also be evaluated, depending upon s ite-specific conditions. The sampling and analysis plans are examined separately for completeness and technical adequacy.

14. NCRs and Discrepancy Resoluti on Forms (RH and CH): These el ements 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 th e AK accuracy report is assessed in three areas: reassignment of the waste to a diffe rent SCG, reassignment of the waste to a different waste stream, and waste stream-spe cific 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 wast e stream are evaluated with the SCG, but the composition of the waste stream with resp ect to individual co mponents and general percentages (mass or volume) is also impor tant 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, althou gh 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 fo llowing 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)7 • Liquids

• Physical Form, including metals and CPR

II. Non Destructive Examination – Real-T ime 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 insp ection elements, but these are documented in the individual inspection reports. 4 Each EPA inspection report disc usses EPA’s evaluation of the elements listed below; elements evaluated for t echnical adequacy and EPA’s report cite objective evidence examined including source documents , inspection interview results, and other information. This listing is a star ting point, and items are typically added or removed as a result of the pre-inspection review pro cess or during th e 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 record s reviewed during the inspection is provided.

C. Technical Evaluation

1. Overall procedural adequacy and implementa tion: 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 revi ew of records, and BDRs are reviewed in conjunction with other pertinent documents such as work inst ructions and Non Conformance Reports (NCRs).

2. Characterization of WMPs and prohibited items : All types of record s are reviewed and, whenever possible, an RTR event is observed. A description of the RTR process is provided in this section. Whenever possible, a demonstrat ion is observed to verify set up of equipment,

identification of WMPs and a ssignment of WMP weights. Operators are interviewed as

necessary.

3. Documentation of radiography activities: Compar ison of written and audio/visual records reviewed to ensure consistency.

4 When preparing for EPA inspections/T 1 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 evaluatio n, recognizing that site-s pecific documents may be required.8 4. Adequate documentation of procedures and processes: BDRs are examined to ensure complete records and NCRs are reviewed; cons istent review of RTR data is determined.

5. Training of personnel: Both writ ten and audio/visual training records are reviewed to ensure that they are current and onl y 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 revi ewed during the insp ection is provided.

C. Technical Evaluation

1. Overall procedural adequacy and implementa tion: The SOP(s) used to perform VE are reviewed to ensure they are complete and adeq uate. Implementation of the SOP(s) is verified by review of records. BDRs are reviewed in conjunction with other pe rtinent documents such

as work instructions and NCR forms.

2. Characterization of WMPs and prohibited items : All types of record s 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 ve rifies the correct assignment of WMPs and their estimated or actual weights. Op erators are interviewed as necessary.

3. Documentation of VE activities: Comparison of written and/or audio/visual records reviewed if such recordings are available. Written reco rds 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. Cons istent review of VE data is determined

5. Training of personnel: Training reco rds are reviewed to ensure th at 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 qua lified personnel are designated to fulfill this function.

III. Non Destructive Assay – CH TRU Wastes

A. Waste Characterization Element Description9 As part of the inspection, EPA typically examines the following items:

• System design and history

• Reports that document the system’s calibra tion, calibration verifica tion and calibration confirmation, as appropriate

• Applicability of the system’s calibrated/opera tional 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 a nd 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 review ed 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 rela ted aspects, namely, the technical merits of the activities that support the radionuclide values produced by each sy stem, 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 opera tional 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, prov ide 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 c onfirmation and calibration verification, as appropriate: This varies, depending on the system’s appr oval history with EPA and operating history, and includes an evaluation of the radionuclid e and matrix standards used

for all calibration-related activities.10 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 concentrati ons of TRU radionuclides at 100 nCi/g.

8. The status of each system with respect to pa rticipation 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 asse ss the system’s precision.

IV. Radiological Characteri zation – RH TRU Wastes

A. Waste Characterization Element Description

The technical adequacy of the radiological charac terization processes that EPA observed initially depended largely on the development and applic ation 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 nondestru ctive testing at DOE laboratories at INL and ANL, or ancillary measur ement 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 AGHC F 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 Char acterization Project Remote -Handled Radiological Characterization Technical Report For Remo te-Handled Transuranic Waste From the Specific Site; current revision11 • CCP-AK-XXXX-5X0, Central Characterizat ion Project Acceptable Knowledge Summary Report For Specifi c Site; current revision

• CCP-AK-XXXX-5X2, Central Char acterization Project RH TRU Waste Certification Plan for 40 CFR Part 194 Compliance and Conf irmation Test Plan for Specific; current

revision

• CCP-TP-504, CCP Dose-To-Curie Survey Proc edure 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 as pects of radiological char acterization, e.g. laboratory qualifications, procedures, reports, data packag es, 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 in spection. These elements are not listed by priority.

1. The technical adequacy and documentation of radi onuclide inventory or ot her historical data to support radiological characterization.

2. Data obtained from the application of a meas urement technique that supports radiological characterization (radiochemical, NDA, mass sp ectrometry, ICPMS, ISOCS) are evaluated, including an evaluation of the technique’s technical basi s and regulatory status, including ancillary documents.

3. Data obtained from the application of other techniques that support radiological characterization (length or mass determinati on) are evaluated, incl uding the technique’s technical basis and regulatory st atus and ancillary documents.

4. The development of radionuclide scaling factors is evaluated, includi ng the application of modeling (ORIGEN, MCNP, Micros hield®) or other techniques.

5. Training for all radiological characterization personnel (i ncluding data reduction and validation) and the adequacy of written proce dures 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.12 7. Other technical aspects and doc umentation of the radiological characterization process are evaluated, including attainme nt of appropriate DQOs.

8. The technical basis, derivation and do cumentation 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.