EPA DOCKET No. A-98-49, II-A4-62



### 40 CFR 194.8 GUIDANCE DOCUMENT

U.S. Environmental Protection Agency Office of Radiation and Indoor Air Center of Federal Regulations 1200 Pennsylvania Avenue, NW Washington, DC 20460

April 2006Disclaimer

This document is intended solely as a guide providi ng suggestions and acceptable ways of implementing the Environmental Protection Agency’s (EPA) inspection and approval process established at 40 CFR 194.8. The document is not b inding and EPA officials may decide to follow the guidance, or act at variance with the gu idance, based on an analysis of specific circumstances. The EPA reserves the right to updat e this document as needed to reflect changes that may be necessary as the Agency verifies regula tory compliance of transuranic waste sites with the WIPP Certification Decision ( Federal Register , Vol. 63, No. 95, May 18, 1998, pp. 27354, 27405).i 

### TABLE OF CONTENTS

Section Page

1.0 Introduction...................................

................................................... ................................... 1 1.1 Regulatory Background ..........................

................................................... ............. 1 1.2 Implementation of Revised Section 194.8(b) .....

................................................... . 2

2.0 Pre-Inspection Activities......................

................................................... ............................ 5 2.1 Documents and Records Required for Baseline Ins pections .................................. 6

3.0 Performance of Site Inspection.................

................................................... ..................... 11

4.0 Preparation of Draft and Final Inspection Repor ts by EPA and the Public Participation Process..............................

................................................... ........................ 13 4.1 Tiering of Waste Characterization Components... ................................................ 14 4.2 Seeking Public Comment on Proposed Approval Dec ision ................................. 23

5.0 Post-Decision Program and Status Tracking ......

................................................... ........... 25 5.1 Tracking of Tiering Changes by EPA.............

................................................... ... 25 5.2 Tiering Changes Initiated by EPA ...............

................................................... ...... 26

6.0 EPA Evaluation of Tier 1 and Tier 2 Submissions from DOE......................................... 2 8 6.1 Tier 1 Changes .................................

................................................... .................. 28 6.2 Tier 2 Changes .................................

................................................... .................. 31 6.3 Waste Characterization Program Changes Not Requ iring Notice and Approval ...........................................

................................................... ................. 33 6.4 Specificity of EPA Approvals...................

................................................... ......... 33

7.0 Other ..........................................

................................................... .................................... 34

8.0 Summary........................................

................................................... ................................ 35

9.0 References.....................................

................................................... ................................. 36

10.0 Acronyms and Initializations/Abbreviations ....

................................................... ............. 37ii 

### LIST OF FIGURES

Figure 1. Summary of Baseline Compliance Decision Process............................................ ..........4 Figure 2. Site Baseline Process — Pre-Inspection A ctivities.......................................... .............10 Figure 3. Site Baseline Inspection Process and Com pliance Decision................................... ......24 Figure 4. Tier 1 Evaluation .......................

................................................... .................................30 Figure 5. Tier 2 Evaluation .......................

................................................... .................................32



### LIST OF TABLES

Table 1. Potential T1 and T2 Elements by Technical Area .............................................. ........... 151

1.0 INTRODUCTION

This document provides guidance on the process that the U.S. Environmental Protection Agency (EPA) uses to conduct waste characterization (WC) p rogram inspections at the U.S. Department of Energy’s (DOE) transuranic (TRU) waste sites to establish baseline approval for the disposal of TRU waste at the Waste Isolation Pilot Plant (WI PP). EPA believes that this guidance will assist the Carlsbad Field Office (CBFO) and TRU was te generator sites in preparing for EPA inspections and approvals. In October 2004, EPA pr omulgated changes to EPA’s site inspection and approval process at 40 CFR 194.8 (see 69 FR 425 71). These changes require EPA to conduct baseline inspections at all EPA-approved TR U waste generator sites (e.g., Hanford Site, Idaho National Laboratory) and new sites (e.g., Oak Ridge National Laboratory).

EPA intends to use the process discussed in this gu idance to develop a baseline approval regarding the acceptability of WC programs and proc esses implemented at TRU waste generator sites when characterizing TRU wastes prior to their disposal at WIPP. This document discusses EPA’s requirements and expectations concerning CBFO and waste generator sites’ activities to support EPA inspections which are conducted to veri fy TRU sites’ compliance with the WIPP Compliance Criteria.

1.1 Regulatory Background

Section 194.24 requires that all waste characterist ics, such as solubility, ability to generate gas, formation of radionuclide-bearing colloids, sheer s trength and compactability, are identified and assessed for their impact on the performance of the WIPP repository. Additionally, the impacts on WIPP performance of waste components, such as me tals, cellulosics, chelating agents, water and other liquids, and curie activity of each radio nuclide are also assessed. Methods used to quantify the limits on waste components must be des cribed. EPA is authorized to use inspections, audits, and record reviews to verify c ompliance with §194.24 requirements described above.

On May 18, 1998, EPA issued a decision certifying t hat the WIPP complies with EPA’s radiological waste disposal regulations. As part o f this decision, EPA determined that DOE was in compliance with the requirements of §194.24, and that one waste generator site, Los Alamos National Laboratory (LANL), was approved to dispose of debris waste at WIPP. Condition 3 of EPA’s WIPP Certification Decision (63 FR 27405) spe cified that no shipments of waste from any generator site (except for one stream from LANL ) could be made to the WIPP until EPA approved the processes to be used for characterizin g the waste streams. As part of its compliance decision, EPA added a new section to 40 CFR Part 194 to describe the waste shipment approval process (§194.8, “Approval Proces s for Waste Shipment from Waste Generator Sites for Disposal at the WIPP”). Sectio n 194.8(a) and §194.8(b) address quality assurance (QA) programs and WC programs at TRU wast e generator sites, respectively.

On July 16, 2004, EPA amended §194.8(b) (69 FR 4257 1, “40 CFR Part 194 Criteria for the Certification and Re-Certification of the Waste Iso lation Pilot Plant’s Compliance with the Disposal Regulations: Alternative Provisions”). T he impetus for these changes was the result of EPA’s waste characterization experience for the pas t five years where EPA had to publish a2

Federal Register (FR) notice. That is, any time ap proved waste generator sites were to add new equipment or request approval of a new waste stream . Secondly, public involvement in EPA’s decision-making was limited. For example, the orig inal site approval process sought public comment on DOE’s upper tier documents implemented b y a site being inspected but not on the WC program approval decision. Consistent with 69 F R 42571, this revision maintains or improves EPA’s oversight at WIPP to ensure safe dis posal of waste. The purpose of this guidance is to describe how the revised §194.8(b) i s to be implemented.

1.2 Implementation of Revised Section 194.8(b)

Under the revised requirements of 40 CFR 194.8(b), EPA will conduct a baseline site inspection at each waste generator site. If, based on the ins pection and documentation provided by the TRU waste sites, EPA determines that the site WC progra ms and processes meet the requirements of 40 CFR 194.8(b), EPA will announce its intent to ap prove the site’s WC program (the Baseline Compliance Decision) in the Federal Register and so licit comments for a period of at least 45 days. The FR notice will describe EPA’s propose d approvals and the requirements for reporting any future changes to the approved baseli ne programs.

The basic steps in issuing a Baseline Compliance De cision are summarized below:

(1) DOE sends a letter to EPA indicating:

- The site is prepared to ship waste to the WIPP.

- Program plans and other WC documentation available for inspection.

(2) EPA may request additional documentation prior to a n inspection to prepare checklists to assess the site’s compliance with the EPA requireme nts that are incorporated in DOE’s WIPP Waste Acceptance Criteria (WAC).

(3) EPA conducts a baseline compliance inspection at th e site: - EPA determines the scope of the inspection based on the site’s readiness as presented in a letter from DOE.

- EPA conducts the inspection to:

• Verify the adequacy of WC program plans and technic al procedures; and

• Validate that plans and procedures are effectively implemented and that WC technical processes are adequately documented.

- EPA witnesses a demonstration by the site of releva nt WC processes, including the following:

• Verification that each site performing characteriza tion of TRU waste can quantify the amount of each waste component emplaced at WIPP, an d the total is within the limits set in §194.24(c).

• Collection and use of acceptable knowledge (AK).3

• Use of destructive and nondestructive techniques fo r identifying and measuring waste components.

• Validation, control, and transmittal of WC data to the WIPP Waste Information System (WWIS) database.

(4) If, based on the inspection, EPA concludes that the site has not adequately demonstrated regulatory compliance, EPA will provide a letter to DOE describing all deficiencies, and place a copy of the report in the public docket.

(5) EPA may require additional documentation and conduc t additional inspections to ensure that the identified deficiencies are corrected.

(6) If EPA determines that the site meets the requireme nts of §194.8(b), the Agency will issue an FR notice describing EPA’s inspection and proposed approval, opening a public comment period on the proposed approval and the baseline in spection report. The proposed Baseline Compliance Decision will identify any limitations o n approved waste streams or WC processes. In addition, the notice will specify ho w future changes to the approved WC processes will be reported to EPA (see Section 4.1 for details).

(7) EPA’s inspection report will be available from the EPA docket and from the EPA website.

(8) After reviewing and responding to public comments o n the proposed approval and a draft inspection report, the final EPA baseline approval will be transmitted to DOE via letter. A copy of EPA’s approval and the final inspection rep ort will be placed in the EPA docket and available from the website.

These steps are illustrated in Figure 1, Summary of Baseline Compliance Decision Process

.4Figure 1. Summary of Baseline Compliance DecisionProcessDOE provides notification letter anddocumentation of site readinessEPA requests additional documentationEPA conducts site Baseline Compliance Inspection* (*see last paragraph under Section 2.0)EPA rejects DOE request for site approvalEPA sends noticeto Public DocketDOE provides additionaldocumentationEPA conducts additional siteinspection(s)EPA announces proposed Baseline Compliance Decisionin FR. EPA identifies through tier designations how future changesin waste characterization processes are to be implemented. EPA sends draft reports and tier designations to Public Docket.EPA solicits public comments and amends compliancedecision as appropriateEPA sends notice of Compliance Decision to DOE(available from EPA Docket and website)EPA may requestadditional information5

2.0 PRE-INSPECTION ACTIVITIES

This section describes those activities that are ex pected to precede the baseline compliance inspection at a TRU waste site (i.e., those events and activities occurring prior to the inspection specified in §194.8(b)(2)(ii)). The process is tri ggered per §194.8(b)(2)(i), which states the following:

DOE will notify EPA by letter that a transuranic wa ste site is prepared to ship waste to the WIPP and has established adequate wast e characterization processes and programs. DOE will also provide the relevant w aste characterization program plans and documentation. EPA may request a dditional information from DOE.

As described above, the Site/CBFO is required to no tify EPA in writing when a site is prepared for an EPA baseline inspection. Identification of any limitations on the scope of the site inspection are helpful for EPA in planning for the baseline inspection. For example, a site may not be prepared to deal with remediation-derived so ils that would be generated in the future, but would be prepared to characterize debris or solid w aste currently in storage. Accordingly, the letter notification would specify any such limitati ons to the scope, as well as limitations relative to the characterization technique to be assessed. For example, some small-quantity sites may choose not to perform radiography, instead choosing to perform 100% visual examination (VE). The site letter would specify this limitation and i dentify any site-specific nondestructive assay (NDA) or nondestructive examination (NDE) instrumen tation planned for use with these wastes. Further, the letter must be specific about whether waste to be inspected includes both retrievablystored and newly-generated waste within the Summary Category Groups (SCGs). For purposes of clarification, the term retrievably-stored wastes refers to those wastes that were generated by and stored at a TRU site prior to the site having i n place an EPA-approved QA program. When the stored wastes are retrieved for characterizatio n prior to disposal at WIPP, the characterization must occur under an EPA approved program, irrespect ive of the time frame under which the wastes were generated. Following EPA approval of a site’s QA program, any waste generated and characterized for disposal at WIPP under the EP A approved program is considered a newlygenerated waste.

After receipt of the DOE readiness letter, EPA and CBFO/Site will establish a mutuallyagreeable date for the inspection. EPA finds it pa rticularly useful to examine as much relevant information as possible prior to site inspections i n order to ensure that the inspection focuses on hands-on activities that cannot be performed apart from the site inspection, such as instrumentation demonstrations. EPA believes that the most efficient way to acquire relevant information on the WC program and its documentation is for CBFO/Site to provide a complete listing of all relevant plans, procedures and other documentation concurrently with the readiness letter. EPA will then indicate which documents fro m the list are required for the baseline compliance inspection.

EPA baseline and follow-up inspections might not oc cur at the same time that CBFO is conducting its QA audits at DOE sites. In such cas es, CBFO observers may be present during EPA inspections. The presence of CBFO observers ca n facilitate conveying of information to6

CBFO regarding issues raised by EPA during an inspe ction, whether the site was able to identify acceptable solution(s) to resolve EPA findings and concerns that require a response, as well as commitments the site has made in addressing EPA iss ues. EPA expects a site’s final responses to its issues on or before the date agreed upon by the site and EPA. CBFO will continue to inform EPA of its schedule of QA audits of TRU site s and EPA may opt to be present at these audits as observers or perform concurrent inspectio ns.

2.1 Documents and Records Required for Baseline Inspect ions

EPA expects documentation requested by the Agency b e made available to the EPA inspection team no less than 2 weeks prior to the agreed-upon inspection date. The documentation is to be reflective of the types of waste streams to be incl uded in the baseline inspection (e.g., S5000 retrievably-stored debris—direct loaded, uncompacte d; S5000 newly-generated debris— compacted; S3000 retrievably-stored solids—direct l oaded, uncompacted), and the specific instruments and/or measurement systems the site pro poses to use for WC.

Examples of documentation that might be required fo r review prior to the baseline inspection are listed below by technical areas relevant to WC. Th is list is not comprehensive but indicates the types of documents EPA may need in preparing checkl ists to evaluate processes, procedures, and equipment during the inspection. Other documentati on of more general interest that may be requested is also listed.

Acceptable Knowledge (AK)

• AK-related procedures or plans

• Container management and WWIS-related procedures an d plans

• Solid sampling procedures or plans, if this include s radiological sample collection and destructive assay in lieu of or to support NDA

• Waste stream profile generation and review-related procedures or plans

• AK summaries for a waste stream from each SCG manag ed at the facility that will be included in an inspection

• Container list showing containers in each example w aste stream available for EPA inspectors to select drums for traceability analysi s, and characterization status of these containers (i.e., showing containers completely thr ough the characterization process, partially through, etc.)

• Documentation supporting the absence of radiologica l data in the AK summary

• AK road map (reference list) for each example waste stream7

• Completed example Waste Stream Profile Form (WSPF) and Characterization Information Summary (CIS) for each example waste st ream

• Other supporting AK documents, as applicable

Nondestructive Assay (NDA )

• Current revisions of the procedure(s) that address instrument setup/calibration, determination of correction factors, and operation for each instrument within the inspection’s scope

• Reports or other documents that record the results of instrument calibration, calibration confirmation, determination of correction factors ( as applicable), determination of total measurement uncertainty (TMU), and lower limit of d etection (LLD) for each instrument within the inspection’s scope

• Documentation of an instrument’s performance histor y for specified time periods

• List of currently-qualified expert analysts (EA) or expert reviewers (ER)

• Anticipated status of each instrument at time of (o r directly prior to) inspections (i.e., in service or out of service)

• List of at least 20 containers per waste stream per analytical equipment, organized by matrix, date of assay, and radionuclide content for replicate analysis

Radiography

• Procedure(s) that are used for radiography operatio n and data recording

• Procedure(s) used for training and qualification of radiography operators and subject matter experts (SMEs), however named, including a l ist of training container requirements

• List of currently-qualified radiography operators a nd SMEs

• Procedure(s) used for radiography data review and v alidation (data generation and project level)

• List of completed batch data reports (BDRs) for the preceding 6 months

• Procedure(s) that addresses records retention for r adiography8

Visual Examination as a QC Check/Visual Examination Technique (VE/VET)

• Procedure(s) used for execution of VE as a quality control (QC) check of radiography and data recording

• Procedure(s) used for executing VET and data record ing for newly-generated waste

• Procedure(s) used for training and qualification of visual examination experts (VEEs) and SMEs (VE/VET)

• List of currently-qualified VEEs and SMEs

• Procedure(s) used for VE/VET data review and valida tion (data generation and project level)

• List of completed BDRs for the preceding 6 months

• Procedure(s) that address records retention for VE/ VET

• Procedure(s) used for the determination of miscerti fication rates

WIPP Waste Information System (WWIS)

• Procedure(s) that address data entry, review, corre ction, and transmittal of data to the WIPP via the WWIS

• Procedure(s) that address records retention for the WWIS process

• Procedure(s) used for training and qualification of data entry personnel and waste certification officials (WCOs)

• List of currently-qualified data entry personnel an d WCOs

Other Documentation

• TRU Waste Quality Assurance Project Plan (QAPjP)

• TRU Waste Certification Plans

• Training and Qualification Plan

• Project-level data validation and verification proc edures or plans

• QA procedures or plans related to software9

• Program-level review, validating, and reporting rel ated procedures or plans

• Data Quality Objectives (DQO) reconciliation-relate d procedures or plans

• Nonconformance Reports (NCR) or other means used by a site to record and track technical issues through completion

The listings above may vary depending upon site-spe cific details, e.g., specific instruments or measurement systems the sites plan to use or wastes the sites plan to characterize. EPA prefers that all documents be provided by the two-week dead line in electronic format, when available. If revisions are made to other procedures or docume nts after the two-week deadline, EPA will accept and review these at their discretion.

EPA will review the documents and data provided and may request additional information based upon this review. Any additional information reque sted should be provided to EPA within a week after receipt of the request. For example, re view of an NDA procedure may show that a document not provided previously includes valuable information pertinent to the NDA system. In this case, EPA may request this document prior t o the site inspection. If EPA is not provided with the requested documentation during the time sp ecified in the EPA request, the Agency may need to delay its inspection to ensure that the nec essary material is provided and reviewed prior to the site inspection.

The major steps in the pre-inspection process are s ummarized in Figure 2, Site Baseline Process — Pre-Inspection Activities

.10Figure 2. Site Baseline Process — Pre-Inspection ActivitiesDOE Notifies EPA of Site ReadinessDOE Provides List of Plans and DocumentationDOE and EPAEstablish Inspection DateEPA Drafts Letter for Inspection and IdentifiesInformation Needs and Requests InformationEPA RequestsInformationNoYesNoNoYes1Inspection based on procedurerevisions provided two weeks beforeinspection. EPA discretion used ifchanges made less than 2 weeks priorto Inspection date.2Appropriate means the documents areconsistent with EPA’s request and areadequate to support the preparation ofinspection checklists.YesEstablish NewInspection DateEPA Proceeds with Site InspectionDocuments1ReceivedTwo WeeksPrior? (Y/N)DOE ProvidesAdditionalInformation?(Y/N)DocumentsComplete andAppropriate2?(Y/N)11

3.0 PERFORMANCE OF SITE INSPECTION

• Specifics of how the inspection will be performed a nd examples of notification protocols:

− EPA receives site inspection notification letter

− Agreement between EPA inspection scope and the Site /CBFO expectations via a conference call between all interested parties upon receipt of the inspection notification letter

− EPA issues the inspection scope letter discussing:

• Logistics, i.e., inspection dates and times, propos ed entrance and exit meetings

• Listing of inspection personnel

• EPA team space and electronic requirements

• Anticipated EPA briefing times for site management

• Documents needed by EPA team members prior to inspe ction

• Requests for other items, if appropriate

• Logistics for replicate testing

• Specifics of how EPA will identify issue(s) of nonc ompliance and resolution pathway (i.e., how issues identified during the inspection will be tracked and resolved):

− Issue identified by the EPA inspector during the in spection

− Discussion among EPA inspection team, and initiatio n of an EPA Inspection Issue Tracking Form

− If necessary, perform further investigation to clea rly define the extent of the noncompliance identified

− Collect objective evidence of noncompliance

− Discuss contents of the EPA Inspection Issue Tracki ng Form with relevant onsite personnel

− Identify EPA regulatory requirement not met

− If issue is assessed to be insignificant, inform th e site personnel that a finding/concern form will not be issued

− Provide an explanation of why the issue was assesse d as being insignificant to site personnel12

− The EPA inspection team determines whether issue is a finding or a concern. 1 A finding always requires a response. A concern may or may not require a response.

− EPA inspection team specifies a date by which EPA e xpects site’s response to a finding or concern

− EPA inspector completes an EPA Inspection Issue Tra cking Form for each finding and/or concern

− Issue presented to cognizant CBFO QA representative (if present) and Site Program Manager (SPM) at the next morning briefing

− SPM may discuss response (corrective action plan) t o address EPA issue and resolution deadline before the EPA closeout meeting

− If the site provides objective evidence of correcti ve action during the onsite inspection, the EPA inspector will evaluate the sit e’s response to determine if the finding/concern was adequately addressed and docume nted

− If the determination is that the finding/concern wa s successfully resolved, the inspector collects and inventories the objective ev idence for inclusion in the inspection report

− EPA informs the site that the finding/concern was s uccessfully resolved

− If the inspector’s determination is that either the corrective action implemented or the objective evidence presented by the site is insuffi cient or inadequate to resolve the finding/concern, the inspector informs the site and provides an explanation for this determination

− Objective evidence of corrective action for finding /concerns received after the conclusion of the inspection will be assessed by EP A to determine if the site successfully resolved the issue

− The site is informed of the determination made, and if the finding/concern was successfully resolved

− If not successfully resolved, the site is provided the new due date for resolution of the finding/concern in writing

1 A finding is defined as a determination that a spec ific item or activity does not conform to 40 CFR 194.24(c)(4). A finding requires a response from CBFO. A concern is defined as a judgment tha t a specific item or activity may or may not have a negative eff ect on compliance and, depending on the magnitude o f the issue, may or may not require a response.13

4.0 PREPARATION OF DRAFT AND FINAL INSPECTION REPORTS B Y EPA AND THE PUBLIC PARTICIPATION PROCESS

This section describes the process that EPA will us e to arrive at a Baseline Compliance Decision and announce its decision in draft and final baseli ne site inspection reports, including public participation in the compliance decision. Section 194.8(b)(2)(iii) states the following:

The agency will announce in the Federal Register a proposed Baseline Compliance Decision to accept the site’s compliance with §194.24(c)(4). We will place the inspection report(s) and any supporting d ocumentation in the public docket described in §194.67. The site inspection r eport supporting the proposal will describe any limitations on approved waste str eams or waste characterization processes. It will also identify (through tier designations in accordance with paragraph (b)(4) of this section) w hat changes to the approved waste characterization processes must be reported t o and approved by EPA before they can be implemented. In the notice, we will solicit public comment (for a minimum of 45 days) on the proposed Baseline Comp liance Decision, including any limitations and the tier designations for futur e changes or expansions to the site’s waste characterization program

. As described in §194.8(b)(2)(iii) above, EPA will p repare a draft site inspection report(s) supporting its proposed Baseline Compliance Decisio n. The inspection report includes all findings and concerns identified during the inspect ion and the resolution, if applicable. If the site failed to respond by the due date specified on the EPA Inspection Issue Tracking Form, dialogue with the Site/CBFO will be initiated or continued i n order to establish a plan to address outstanding issues from the inspection. EPA would not finalize a report until all findings or concerns have been resolved. EPA will finalize the draft site inspection report and prepare a FR notice summarizing the inspection scope and conclus ions and request public comment. The draft site inspection report and any supporting documenta tion will be placed in the public docket and be available from the EPA website.

Each baseline inspection report shall provide, at a minimum, the following information, as applicable:

• Identification of inspection and scope

• Identification and description of WC elements

• Documents reviewed, i.e., site procedures and repor ts

• Site personnel interviewed, with the affiliation an d pertinent technical area of expertise

• Waste container and batch data reports (BDRs) revie wed for each technical area

• Technical evaluation

• Completed inspection checklists for each technical area

• Replicate test results and analysis

• Determination of the technical adequacy for each te chnical area14

• Inspection issues, i.e., findings and concerns, including site response(s)

• Proposed baseline approval for each technical area assessed

• Description of how changes to the proposed WC progr am will be reported to EPA after the EPA approval

• Proposed tiers listed by each technical area assess ed, i.e., Tier 1 (T1) and Tier 2 (T2) changes

• Comprehensive listing of all site approvals by tech nical area presented in tabular form

4.1 Tiering of Waste Characterization Components

A key element of the Baseline Compliance Decision i s the tier designation process, which indicates how DOE will inform EPA of changes to WC processes, procedures or equipment. It provides a path for making changes/additions to the approved WC process(es) following EPA’s final approval as documented in the Baseline Inspec tion Report.

EPA’s proposed Baseline Compliance Decision will de signate potential changes/additions to approved WC program elements as T1 or T2. Changes that are likely to have direct and significant effect on WC data quality are designate d as T1 changes. Changes made to improve WC processes and do not alter implementation of app roved WC components are viewed as T2 changes. Other site-specific conditions could dict ate a tiering designation that differs from the above criteria. T1 changes require CBFO/Site to ob tain written EPA approval of the change/addition prior to implementation of the chan ge. T2 changes require CBFO/Site to notify EPA in writing of the change according to the sched ule established in the report, i.e., quarterly, but EPA approval is not required prior to the imple mentation of T2 changes. EPA suggests that a summary of T2 changes be submitted on a quarterly basis or on another schedule established in the inspection report. Changes to WC procedures no t specified as T1 or T2 in the Baseline Compliance Decision do not require notice to EPA. Table 1 presents a list of items that have the potential to be designated as T1 and T2 for each of several technical areas. The elements listed under each of the technical areas are based on EPA’ s inspection experience. The list is by no means comprehensive and EPA may add additional elem ents as we conduct more baseline inspections.

EPA considers site-specific upper tier documents su ch as the TRU Waste Certification Plan and Quality Assurance Project Plan (QAPjP) to be critic al to the characterization of TRU wastes. Accordingly, EPA requires notification regarding al l changes to these documents with the potential to impact TRU WC activities within EPA’s purview.

Proposed changes to WC processes, procedures, or eq uipment will be assigned T1 or T2 status depending on the type of waste(s) evaluated, limita tions of assay or measurement equipment, and adequacy of procedure(s). EPA will make tiering a ssignments for each proposed change to a WC process, procedure or system (equipment) at its discretion, consistent with the information in this document and the requirements of 40 CFR 194.8( b). The site inspection report may also specify the contents of any future T1 and T2 change notifications. EPA shall describe all T1 and15

T2 reporting requirements unique to each site in th e site inspection report supporting the Baseline Compliance Decision (§194.8(b)(2)(iii)).

During the baseline inspection process, each site p rovides a list of TRU WC personnel from which EPA selects a few individuals to be interview ed. The EPA inspectors review the qualifications and training records of these indivi duals to assess their WC capabilities. Based on this evaluation EPA makes a determination regarding the training of WC personnel responsible for characterizing TRU waste and certifying it as T RU waste to ensure that they are well qualified and have received adequate training to pe rform their assigned function. EPA may review the training and qualifications of the key W C personnel at any time. EPA may conduct periodic records reviews and interviews of WC perso nnel to ensure the quality of this aspect of the waste characterization process.

Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Docume ntation Required
Acceptable Knowledge (AK) AK-1 Change in requirements for

AKE (Acceptable Knowledge Expert) AKE training requirements - Training records - Training documents - New training standards
AK-2 Change in AK procedure Change in AK-related requirements - AK procedures - Quality Assurance Project Plan (QAPjP) - Upper tier Waste Analysis Plan/Waste Acceptance Criteria (WAP/WAC)

AK-3 Addition of waste stream

within approved grouping New retrievably-stored debris stream that was not examined during baseline inspection, but is within an approved procedure - WSPF

- CIS - Site-specific attachments or other information

AK-4 Addition of waste

stream/group outside of approved grouping Newly-generated soil at Idaho National Laboratory (INL) - AK summary

- WFPG

- CIS - Select mandatory/supplemental information, site-specific attachments, or other information
AK-5 (related to AK-2) Change in mandatory

site/waste stream data collection requirements 10 nuclides, Cellulosics, plastics and rubber (CPR)
Ferrous/nonferrous metals - AK summary - Mandatory data - Any AK-related attachments
- Other

AK-6 Addition of load

management Addition of load management to AK - AK summary - Supplemental documents16 Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Docume ntation Required

summary AK-7 Addition of previously

identified ineligible waste Tank waste, high-level
waste - AK summary - All supporting documentation pertinent to re-designation
AK-8 Change in §194.22 historic

AK verification process Peer review replaces sampling/analysis confirmation of historic AK data - AK summary - Peer review report - QA equivalency checklist - Relevant supplemental data
AK-9 Identification of major

changes to AK summary, including changes as a result of AK measurement comparison Volume, new nuclides, changes to AK-identified isotopic distributions as a result of measurement - Revised WSPF - Revised AK summary
- Other

AK-10 Changes in use of AK by

NDA outside of approved or evaluated process Use of unsubstantiated AK by NDA - AK summary - Example of data
- Other
AK-11 Changes in AK-QA

performance, quality assurance objectives (QAOs) and performance tracking Dramatic increase in AK inaccuracy/ information inconsistencies - AK summary - AK accuracy report (or similar document) - Supporting documents
AK-12 Minor change in AK

procedure that was approved by CBFO post-inspection Addition of new checklist or attachment to an AK procedure - AK procedure

AK-13 Changes in load

management status of approved waste streams Determination based on analysis that load management is required for a waste stream within an approved SCG for which load management was already approved - AK summary - Notification to EPA as per Contact-Handled Waste Acceptance Criteria (CH WAC) Rev. 3 Appendix E requirements

AK-14 Inclusion of waste

containers in a waste stream from an approved SCG that were formerly considered high-level waste (HLW) or low-level waste (LLW) Reclassification of containers for inclusion in a waste stream from an approved SCG - AK summary
- Revised WSPF - CIS (if radiological data included) - Select mandatory/supplemental information addressing HLW determination change
AK-15 Acceptance of new waste

from an offsite generator Remediation waste generated from offsite generator, sent to site for characterization - AK summary for stream - WSPF (draft if sufficient) including CIS

AK-16 Significant decrease in AK

accuracy Waste Matrix Code (WMC) or radiological - AK summary for suspect stream(s)17 Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Docume ntation Required analysis data causes AK accuracy to fall below a specified value (e.g., 50%) - AK accuracy documentation

AK-17 Discrepancy resolution

actions that change AKidentified SCG FastScan identification of different SCGs - AK summary - Discrepancy resolution documentation

AK-18 Addition or modification of

waste profiles as provided in transuranic waste baseline inventory report (TWBIR) Identification of new waste streams within approvedSCG, but not previouslyidentified or included in TWBIR - AK summary
- WSPF for stream

AK-19 Changes in how NDA uses

AK data (e.g., changes to AK-NDA memo) Confidence in AK increases/decreases changing how AK used - AK summary for stream(s) in question - AK-NDA memo or equivalent documentation
AK-20 Combination of unique

waste streams, as identified during EPA’s inspection, into larger or other waste streams, post-EPA inspection Merging of several Rocky Flats Environmental Technology Site (RFETS) small (single/few containers) waste streams into pre-existing waste
streams - Revised WSPF - Revised AK summary for stream - Mandatory/supplemental data, as necessary to justify combination

Radiography
Radiography-1 Change in operator/SME

qualification requirements Change in training requirement - Training records, training documentation, exam, formal training plan, required reading, memo of qualification(s)

- New proposed training qualification standard operating procedures (SOPs) - Previous training qualification SOP changes - Updated training records for all SMEs/operators - Justification for change
Radiography-2 Operator qualification

rescinded Operator fails biannual test and requires retraining - Test container results
- Date of failed container test - Training plan for recertification
- Date of recertification
Radiography-3 Addition of similar unit to

existing (approved) system Radiography unit (same manufacturer and model as unit(s) inspected during the baseline assessment) - Technical specifications - Operating energy range
- Test containers
- Date unit first used for18 Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Docume ntation Required
characterization of waste
Radiography-4 New unit Radiography unit not previously approved by EPA - Technical specifications - Operating energy range
- Test containers

- BDRs
Radiography-5 Change or modification of

procedure Change in data reporting form Description matches waste stream ID, Waste Material Parameters (WMPs), WMP weights, prohibited items - Previous procedures - New procedure - Justification for change

Radiography-6 New procedure New instrument - Proce dure - Superceded procedure (if applicable) - Justification for new procedure
Radiography-7 Change in radiography

frequency (90 containers evaluated by radiography) or change in miscertification calculations Reduce percentage of radiography and miscertification requirements from that specified in baseline - Justification for change in frequency

Radiography-8 Change in project-level

verification/validation process or procedure Modify validation checklist - New procedure - Previous procedure - Justification for change
Radiography-9 Changes to radiography

records Change in audio/video media documentation (cease), change in record retention - Description of audio/video system modification

Radiography-10 Addition of new waste

stream Operator training updates and training container
contents - Qualification docs - Test container tapes/documents

Radiography-11 VE/RTR comparison are no

longer made available to radiography operators VE results are not assessed and given to radiography operators - Procedure
- Justification

Radiography-12 Addition of a new operator

and/or SME New operator qualified New SME appointed - Training records and documentation - Memo of appointment

- Resume19 Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Docume ntation Required Radiography-13 Change or modification to

radiography procedure(s), used at the time of the baseline inspection, that requires CBFO approval Change in data reporting form Change in standardized tables for WMPs - Copy of revised procedure(s), including data sheets
- Evidence that RTR operators/SMEs are trained in the modified procedure - Anticipated affect on RTR data quality, including QAOs - Justification for change
Radiography-14 Addition of new waste

stream Operator training is modified to address new
waste stream Required contents of training container are changed - Evidence of operator/SME training on the WMPs and typical packaging configuration expected to be found in new
waste stream - Changes made to training container contents, if applicable
Visual Examination as a QC Check and Visual Examina tion Technique (VE/VET)

VE/VET-1 Change in VET

operator/SME training and/or qualification requirements VET operator/ SME training/qualifications requirements are revised Operator/SME requalification period is extended Training on the WMPs and typical packaging configurations expected to be found in each waste stream no longer required New waste stream specific training is added - New training/qualification procedure(s), plans, or materials, as applicable - Updated training/qualification records for all operators/SMEs, including formal and on-the-job training - Training information for new waste stream, if applicable - Justification for change(s)

VE/VET-2 Revision to existing

procedures or generation of new procedure(s) used to perform VET examinations (includes data sheets used to document VET data and QC requirements) New or revised procedures/requirements for identification, verification and/or documentation of WMPs, WMP weights, prohibited items (including free liquids), whether waste matches waste-stream description, and WMC Calibration of scale, used to weigh WMPs, revised or deleted Change in requirement for two operators required to perform VET
Standardized charts or - Copy of new or revised procedure - Copy of new or revised data sheets - Copy of BDRs for data generated using the new or revised procedure(s) - Anticipated effect on VET data quality, including QAOs - Justification for change(s)20 Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Docume ntation Required
tables used to aid in the consistent estimation/ assignment of weights, WMPs, and WMCs are changed
VE/VET-3 Data review, validation, and

verification requirements changed from those in place at the time of the baseline inspection Revision or deletion of data review, validation, and verification requirements
Revision or deletion of review checklist items Change in information included in each BDR - Copies of new data review checklists (data generation level and project level) - Copy of BDRs for data processed under these changes - Justification for change(s)

VE/VET-4 Change in records retention

requirements Specific records, retained at the time of the baseline inspection, are no longer to be retained Record retention periods are shortened - Justification for change - New data retention requirements - Copy of revised procedure(s) addressing the change(s)

VE/VET-5 Change or modification to

VE or VET procedure(s) used at the time of the baseline inspection that requires CBFO approval Change in data reporting form Change in standardized tables for WMPs - Copy of revised procedure(s) - Copy of revised data sheets - Copy of BDRs for data generated using the revised procedure(s) - Anticipated affect on VE data quality, including QAOs - Justification for change
WIPP Waste Information System (WWIS)
WWIS-1 Changes made to WWIS

procedure(s)/ algorithms that require CBFO approval TRU concentration is not calculated as a mean of the containers in the payload Change in data review requirements Implementation of or changes to load management - Copy of the new algorithm

- Copy of new payload plans, procedures and documents

- Justification for change

WWIS-2 Change to payload

requirements that were in place at the time of the baseline inspection Change in requirements contained in Appendix E of the CH WAC Change in site requirements for payload management, not contained in the CH WAC - Copy of new payload plans, procedures, and documents
- Justification and basis for change21 Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Docume ntation Required

WWIS-3 Addition of a new SCG

waste to payloadmanagement Site to payload-manage new waste stream from an SCG not part of the baseline inspection - Copy of new payload plans, procedures, and documents, if applicable - Documentation for payloads demonstrating compliance with all requirements of Appendix E of the DOE/WIPP-02-3122 for the added waste stream
Nondestructive Assay (NDA)

NDA-1 Addition of new NDA

system New gamma and/or neutron assay system not previously approved by EPA Technical documentation supporting change: report of system calibration, calibration confirmation, LLD, TMU anddetection capability for 10 WIPPtracked radionuclides
NDA-2 Physical modifications to

approved equipment affecting actual radioassay results (e.g., DQOs compliance, TMU)*

* Changes to the system, such as addition of handrails, intrusion barriers or access controls, containerstaging, or other safetyrelated changes, that do not have the potential to affect radioassay results are excluded. Incorporation of a gamma detector to an approved neutron-only assay system, e.g., adding gamma option to high efficiency neutron counter (HENC) Technical documentation supporting change: report of system calibration, calibration confirmation, evaluation of the change’s effect on LLD, TMU, anddetection capability for 10 WIPPtracked radionuclides

NDA-3 Changes to approved

calibration range for approved equipment Extension of the calibration range of an approved NDA system with respect to disintegration rate and/or matrix, e.g., increasing range from upper limit of 50 g to 140 g Total Pu Technical documentation supporting change: report of system calibration, calibration confirmation, evaluation of the change’s effect on LLD, TMU, anddetection capability for 10 WIPPtracked radionuclides22 Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Docume ntation Required NDA-4 Changes to software for

approved equipment Changing a system’s operating system, e.g., first use of Canberra NDA 2000 on a previously approved system
Identification of a systematic problem with a software package and subsequent modifications to address the problem, e.g., use of an incorrect value for a radionuclide’s transition probability in Genie 2000 in use on an approved system
Introduction of a new version of an existing software package beyond what is in current use, e.g., ANTECH’s MasterScan beyond V5 1.5 that is in current use for the INL CCP Tomographic Gamma Scanner (TGS) Technical documentation supporting change equivalent to what would be required for the system’s initial approval

NDA-5 Changes to operating

range(s) upon CBFO approval Reducing a system’s operating range because of performance-related problems or equipment failures, e.g., if an approved system were to fail a NDA PDP cycle for a specific matrix or activity range and its use for those were formally restricted by the site or CBFO as a result of the failure(s). Technical and compliance related documentation used by the site to track the change, e.g., NCRs23

4.2 Seeking Public Comment on Proposed Approval Decisio n

The changes to § 194.8 modified the public participation process sig nificantly with respect to when the public may comment and the type of materia l available to the public when comment is sought. In the past, public comment was solicited prior to each §194.8 inspection, and only programmatic site documents were docketed for publi c comment. Public comments were then assessed and included in the final inspection repor t prepared by EPA. However, this process did not allow the public the opportunity to comment on EPA’s proposed decisions. Now, the public comments are sought on EPA’s proposed site approval , and the public is given the opportunity to review EPA’s draft inspection report, as well as pe rtinent material supporting this determination.

The public will be allowed at least 45 days to exam ine EPA’s proposed approvals and to submit written comments to EPA for consideration. EPA wil l include responses to comments in the final inspection report. EPA may also revise the d raft inspection report in response to issues or comments raised by the public. The final inspectio n report will be placed in the public docket. In each final report, EPA will establish the specif ic reporting requirements for information pertaining to T1 and T2 changes.

A summary of the steps involved in conducting a bas eline site inspection are illustrated in Figure 3, Site Baseline Inspection Process and Compliance Dec ision

.24 Figure 3. Site Baseline Inspection Process and Com pliance Decision Issues Resolved During Inspection? (Y/N) Site Identifies Resolution Pathway for EPA’s Consideration

Address Comments Prepare Draft Inspection Report - Define T1 and T2 Requirements No Issues Issues 1 Identified and Communicated? (Y/N)

EPA Finalizes Baseline Compliance Decision and Inspection Report Prepare Response to Comments for Inclusion in Final Inspection Report

EPA Issues Approval Letter to DOE (Places Letter and Final Inspection Report in Docket, Available from Website)

Public Comments? (Y/N) EPA Performs Inspection

No Yes

Yes

Yes

No

Site Provides Information to EPA

Issue Resolved? (Y/N) Yes No

1 Issues include both Findings and Concerns.25

5.0 POST-DECISION PROGRAM AND STATUS TRACKING

5.1 Tracking of Tiering Changes by EPA

Reporting of T1 Changes to EPA

Once the baseline is established, a T1 change reque st can be sent to EPA at any time after baseline approval. EPA approval is necessary befor e the site can implement a T1 change and begin to dispose of the waste characterized using t he proposed change. When submitting a proposed T1 change, EPA prefers that the site provi de relevant documentation supporting the proposed change in electronic format. Upon review of the initial submission, EPA may request additional information. Once all necessary informa tion has been received, EPA will make an adequacy determination and will issue a decision le tter. EPA will post any approval decisions on its website including EPA’s analysis of the T1 chan ge and information supporting the T1 change that was provided by the site.

Further, for T1 changes, EPA will amend the final r eport, either through revision of text or by including an attachment detailing the amendment, an d the revised report will be docketed. EPA will also docket and post (on the EPA website) info rmation from any §194.24(h) inspection performed.

Reporting of T2 Changes to EPA

Once a site has been approved via the baseline insp ection process, EPA expects that the site will submit quarterly (or at another schedule establishe d by EPA) tiering status reports (T2 only) in which EPA will be formally notified of T2 changes. Specifics of this process are shown below:

• The reporting cycle for T2 changes will begin three months (or at another schedule established by EPA) following the date of EPA’s bas eline approval the of site’s WC
program

• EPA encourages CBFO/Site to consult with EPA if the y are unsure about the tier level for a change that is not covered in the Baseline Co mpliance Decision

• Complete reports, including the site contact name a nd numbers, will be submitted by the Site/CBFO

• EPA encourages the Site/CBFO to develop a format fo r a T2 notification letter/form which includes, at a minimum, a description of the purpose and extent of the proposed change, supporting material, and the effective date

• Whenever possible, notification will be made to EPA and the designated EPA contractor representative via electronically. In the case of documents that are posted on the DOEs FTP site, DOE should direct EPA to the document num ber (and Revision) and the FTP site where it is available

• EPA will assign an EPA tracking number for the chan ge request26

• EPA will evaluate T2 changes when received and will issue approval and associated conditions as necessary 5.2 Tiering Changes Initiated by EPA

EPA’s baseline compliance decisions do not eliminat e the Agency’s opportunity to identify issues either within or after the tiering process d escribed in this document. The Federal Register, Volume 69, page 42577 states the following:

If, at any time, we [EPA] determine[d] that the sys tem of controls at a site is not adequate to characterize certain waste streams, EPA retains authority to direct that the site may not dispose of material from thos e waste streams or processes at the WIPP until the Agency’s findings have been adeq uately resolved.

This authority is delineated in §194.8(b)(5), which states the following:

Subsequent to any positive determination of complia nce as described in paragraph (b)(2)(iii) of this section, EPA may revi se the tier designations for approving changes or expansions to the waste charac terization program at a site using the following process:

(i) The Agency shall announce the proposed tier changes in a letter to the Department. The letter will describe the Agency’s reasons for the proposed change in tier designation(s). The letter and any supporting inspection report(s) or other documentation will be placed in the dockets described in §194.67. (ii) If the revised designation entails for stringent no tification and approval requirements (e.g., from Tier 2 to Tier 1, or from undesignated to Tier 2), the change shall become effective immediately a nd the site shall operate under the more stringent requirements witho ut delay. (iii) If the revised designation entails less stringent n otification and approval requirements (e.g., from a Tier 1 to Tier 2, or fro m Tier 2 to undesignated), EPA will solicit comments from the p ublic for a minimum of 30 days. The site will continue to operate unde r the more stringent approval requirements until the public comment peri od is closed and EPA notifies DOE in writing of the Agency’s final d ecision.

As described above, EPA will notify DOE (under §194 .8(b)(5)) if any tiering designation requires change.

DOE will be notified by EPA, in writing, of any cha nges to the T1 and T2 reporting requirements. EPA will notify the public of T1 and T2 evaluation results by posting these results (including letter notifications) on the EPA website ( http://www.epa.gov/radiation/wipp/index.html ). EPA will post approval letters and baseline inspection reports on the EPA website. EPA will al so provide electronic updates to the WIPPNEWS e-mail service, which sends e-mail notificatio ns regarding EPA and the WIPP to subscribers (see the previous Web address for subsc ription link). Hard copies of information27

examined by EPA, as well as the letter notification and other related approval documents, will also be included on the EPA docket.28

6.0 EPA EVALUATION OF TIER 1 AND TIER 2 SUBMISSIONS FRO M DOE

Section 194.8(b)(4) describes how DOE can make chan ges to the WC program at a site after EPA has made a baseline compliance determination. The following is stated in §194.8(b)(4):

Subsequent to any positive determination of complia nce as described in paragraph (b)(2)(iv) of this section, the Departmen t must report changes or expansions to the approved waste characterization p rogram at a site in accordance with the tier designations established i n the Baseline Compliance Decision.

(i) For changes or expansions to the waste characteriza tion program designated as “Tier 1,” the Department shall provid e written notification to the Agency. The Department shall n ot ship for disposal at WIPP any waste that has been characterized using th e new or revised processes, equipment or waste streams until EPA has provided written approval of such new or revised systems. (ii) For changes or expansions to the waste characteriza tion program designated as “Tier 2,” the Department shall provid e written notification to the Agency. Waste characterized us ing the new or revised processes, equipment, or waste streams may be disposed at WIPP without written EPA approval. (iii) EPA may conduct inspections in accordance with §194 .24(h) to evaluate the implementation of Tier 1 and Tier 2 changes or expansions to the waste characterization program at a site. (iv) Waste characterization program changes or expansion s that are not identified as either ”Tier 1” or “Tier 2” will not require written notification by the Department to the Agency before implementation or before shipping waste for disposal at WIPP.

6.1 Tier 1 Changes

Section 194.8(b)(4)(i) states that T1 change notifi cations require EPA approval prior to implementation. The rule requires that DOE notify EPA, in writing, of any T1 changes requested by a site with a baseline approval, and e ither provide information specified in the Baseline Compliance Decision or include all informa tion it believes to be relevant to the T1 approval with this request. For example, if a site is seeking approval of an NDA system outside of the scope of the current approval, the Site/CBFO provides all procedures, example BDRs, and a listing of waste containers (from which EPA may s elect candidates for replicate measurements). EPA will assess the information pro vided for completeness, and will determine whether additional information is needed or an EPA site visit is required, as specified in §194.8(b)(4)(iii).

In another example, if a site seeks to dispose of w aste from a SCG, outside of that previously approved by EPA in its Baseline Compliance Decision , it is likely that EPA will request29

additional information, and will perform an onsite inspection under §194.8(b)(4)(iii) and in accordance with §194.24(h). EPA shall notify CBFO/ Site, in writing, if additional information is required (including dates by which the information is to be sent to EPA and the format in which EPA requires the information). If an inspection is necessary, EPA shall contact the Site/CBFO in writing to establish the date for this inspectio n and to work out logistical or other details. Once EPA has acquired the necessary information to make its T1 determination, EPA will notify DOE, in writing, of the completeness determination and shall proceed with the technical evaluation. EPA expects to complete a draft T1 tec hnical evaluation within three weeks of determining that all information required to perfor m the technical analysis has been provided.

EPA, at its discretion, may choose to conduct inspe ctions to evaluate T1 changes or expansions to the WC program at a site, as provided in §194.8( b)(4)(iii). EPA’s evaluation of proposed T1 changes may take the form of an onsite inspection c omparable to the initial baseline inspection, but with a scope limited to the technical aspects p ertinent to the specific T1 change proposed. Alternately, EPA may choose to evaluate the propose d T1 change by performing a desk-top review. This typically consists of DOE supplying d ocuments identified by EPA that are pertinent to the proposed T1 change, but the review of the documents would not occur at the TRU generator site. The desk-top review option may involve additional discussions with DOE and/or site WC personnel, as well as requests for a dditional information, and EPA expects that DOE will provide all needed materials and facilitat e all required communication. EPA shall determine and apply the appropriate mechanism for e valuating a proposed T1 change at its discretion. A summary of the procedure for evaluat ing a T1 process proposed by DOE is illustrated in Figure 4, Tier 1 Evaluation

.30Figure 4. Tier 1 EvaluationIs ModificationQualified forTier 1? (Y/N)Discuss Tier StatusWith DOENotify DOE Changes Can Be ImplementedNotify DOETreat as Tier 2NoYesYesNoYesDiscuss Tier 1 SubmittalWith DOEDiscuss Tier 1 Submittal With DOE –(Disapprove or Resubmit)Disapprove ModificationNoNoResubmitResubmitDocket Decision, Post on WebsiteIs ChangeQualified forTier 1? (Y/N)Is Tier 1SubmittalComplete?(Y/N)IsTier 1Submittal TechnicallyAcceptable? (Y/N)Perform Desk-top Reviewand/or OnsiteInspectionYes31

6.2 Tier 2 Changes

T2 actions are described in §194.8(b)(4)(ii). T2 c hanges can be implemented without EPA’s prior approval. However, for EPA to be aware of th e T2 changes implemented, EPA requires the Site/CBFO report all T2 changes quarterly (or anoth er schedule established by EPA). T2 changes involve changes in processes, equipment, or waste streams associated with the WC program and system of controls that require the sit e to notify EPA when they occur, but do not require EPA approval before they are undertaken. EPA’s Baseline Complia nce Decision will define T2 changes, including reporting requirements (e.g., documentation, due dates) associated with those changes.

Submissions may be provided either electronically ( preferred) or in hard copy and shall be accompanied by a letter from the Site/CBFO that ide ntifies the Baseline Compliance Decision relevant to the proposed T2 change.

EPA will compare the T2 submission contents with th e requirements presented in the Baseline Compliance Decision to ensure that all required inf ormation has been submitted and that the submission is categorized appropriately (i.e., T2 v s. T1). If the information provided does not comply with the requirements explicitly spelled out in the Baseline Compliance Decision, EPA will notify CBFO/Site that the submission is lackin g and will request the missing information by a specified date. EPA will also examine the conten ts of the submission to determine whether any technical information within the submission require s additional documentation or information to fully understand the technical element and its pote ntial impact on WC. If questions arise, EPA will send a letter to CBFO requesting information b eyond that explicitly identified in the Baseline Compliance Decision, or EPA may choose to perform an onsite inspection to gather this information. Once all missing information is obtai ned, EPA shall evaluate the submission to determine whether the content satisfies the intent and requirements of the Baseline Compliance Decision.

For example, EPA’s INL CCP baseline compliance dete rmination required submission of WSPFs for streams in approved SCGs as T2 changes. In this case, EPA would examine the WSPFs to ensure that they are complete and to deter mine whether any supporting information is necessary for EPA to fully understand the submissio n (e.g., a more detailed AK document than that provided with the WSPF). EPA would also revie w the WSPFs to see whether they are within the approved SCGs.

EPA will communicate with CBFO/Site regarding quest ions that arise from the review process and, upon resolution of all issues; EPA will notify the Site/CBFO of their approval of T2 change(s). EPA may, at its discretion, choose to c onduct inspections to evaluate T2 changes or expansions to the WC program at a site, as provided in §194.8(b)(4)(iii).

Upon evaluation of T2 changes, EPA will issue the r esults of its evaluation, which will be docketed. Figure 5 illustrates the steps in a T2 evaluation.32Figure 5. Tier 2 EvaluationYesYesNotify DOE that Changes are AcceptableInform DOE to StopImplementation asT2 ChangeNotify DOE that Changes are AcceptableResubmitNoNoResubmitNoNoYesYesDocket DecisionDisapprove ModificationDiscuss Tier Statuswith DOEDiscuss Tier 2 Submittalwith DOEDiscuss Tier 2 Submittalwith DOE –(Disapprove or Resubmit)IsChangeQualified forTier 2?(Y/N)Is Tier 2SubmittalComplete?(Y/N)IsModificationQualified forTier 2?(Y/N)Is Tier 2SubmittalTechnicallyAcceptable?(Y/N)33

6.3 Waste Characterization Program Changes Not Requirin g Notice and Approval

If a change or expansion to the approved WC program at a site is not defined as either a T1 or T2 change in the Baseline Compliance Decision, then Si te/CBFO is not required to notify EPA that such a change has been implemented. It is possible that there may be certain WC process changes that sites would make to ensure compliance with the EPA regulations at 40 CFR 194.24 but that have not been previously tiered by EPA. I n such cases, EPA recommends that CBFO/Site contact the Agency with any questions reg arding changes that do not appear to be covered by existing T1 or T2 designations. This wo uld minimize any confusion and avoid a potential disapproval of inappropriate T2 changes.

6.4 Specificity of EPA Approvals

When approving T1 and T2 changes, the approval lang uage shall be clear and precise. For example, if a site is approved for additional WC ac tivities or waste types (streams, SCG, etc.) beyond what was approved in the Baseline Compliance Decision through EPA approval of a T1 change, the approval letter would include language similar to the following:

EPA hereby approves the T1 change for the INL CCP, allowing the shipment of wastes from SCG S4000 derived from Pit 4 and the sh ipment of newly generated S3000 and S5000 wastes derived from Pit 4. Shipmen t of wastes from these categories is now a T2 change, requiring provision of Department-approved waste stream profile forms to EPA every three month s.

To avoid any conditional approvals and to offer the maximum approval scope, EPA shall strive to issue approval only when all questions or issues identified by EPA have been resolved. However, if EPA and CBFO/Site reach an impasse rega rding a technical element or issue, or a certain issue cannot be resolved in a timely fashio n, EPA may offer a conditional or partial approval for a T1 or T2 change. In this case, EPA may seek additional information or conduct an onsite inspection to evaluate the implementation of the change.34

7.0 OTHER

In its rulemaking promulgating 194.8 changes, EPA e stablished a process under 40 CFR 194.8(b)(6) which allows the previously appr oved sites to continue to characterize and dispose of approved waste streams at WIPP until a b aseline compliance decision is established. The TRU sites without any prior EPA approval will b e subject to the baseline approval process established under 40 CFR 194.8(b). These sites may not dispose of their TRU waste at WIPP until such approval has been granted (See FR Vol. 6 3, No. 95, May 18, 1998).

The baseline inspection and approval process discus sed in this guidance also applies to TRU waste sites managing and characterizing remote-hand led (RH) waste. However, the RH WC program and process approval differs from the CH WC program approval process. RH sites may not implement their RH WC program until EPA reviews and approves the RH WC processes documents. EPA will then inspect the site to appro ve the program. (See EPA’s RH framework approval letter, March 26, 2004, Docket No. A-98-49 ). RH sites will be subject to the same baseline inspection and approval process discussed in this guidance, in addition to the requirements established in the EPA’s March 2004 RH WC framework approval letter.35

8.0 SUMMARY

This guidance document details EPA’s baseline inspe ction and approval process and suggests the steps that TRU waste generator sites would want to follow to provide documentation concerning their TRU WC program for EPA review and adequacy de termination. After completing the baseline inspection, EPA will prepare a report summ arizing the inspection process, the results of the inspection(s), and the proposed approval decisi on. The public will have 45 days to comment on the proposed approval decision. Upon considerat ion of public comments, EPA will finalize its approval decision and tiering of changes to the WC program.36

9.0 REFERENCES

U.S. Environmental Protection Agency, “40 CFR Part 194—Criteria for the Certification and Re-Certification of the Waste Isolation Pilot Plant ’s Compliance with the Disposal Regulations: Certification Decision; Final Rule,” 63 FR 27354–27 406, May 14, 1998.

U.S. Environmental Protection Agency, “40 CFR Part 194—Criteria for the Certification and Re-Certification of the Waste Isolation Pilot Plant ’s Compliance with the Disposal Regulations: Alternative Provisions,” 69 FR 42571–42583, July 16 , 2004.

U.S. Environmental Protection Agency, Code of Federal Regulations , Title 40, “Protection of Environment,” Part 191, “Environmental Radiation Pr otection Standards for Management and Disposal of Spent Nuclear Fuel, High-Level and Tran suranic Radioactive Wastes.”

U.S. Environmental Protection Agency, Code of Federal Regulations , Title 40, “Protection of Environment,” Part 194, “Criteria for the Certifica tion and Re-Certification of the Waste Isolation Pilot Plant’s Compliance with the 40 CFR Part 191 Disposal Regulations,” 61 FR 5224, February 9, 1996.

U.S. Environmental Protection Agency, “Compliance A pplication Guidance for the Waste Isolation Pilot Plant: A Companion Guide to 40 CFR Part 194,” EPA 402-B-95-014, 1996.

U.S. Environmental Protection Agency Final Report f or the Baseline Inspection of the INL CCP, Docket No: A-98-49; II-A4-59.

U.S. Environmental Protection Agency Draft/Final Re port for the Baseline Inspection of the SRS-CCP, Docket No: A-98-49; II-A4-62.37

10.0 ACRONYMS AND INITIALIZATIONS/ABBREVIATIONS

AK Acceptable Knowledge

AKE Acceptable Knowledge Expert

BDR Batch Data Report

CCP Central Characterization Project

CFR Code of Federal Regulations

CH Contact-Handled

CH WAC Contact-Handled Waste Acceptance Criteria

CIS Characterization Information Summary

CPR Cellulosics, plastics and rubber

DOE U.S. Department of Energy

DQO Data Quality Objectives

EA Expert Analyst

EPA U.S. Environmental Protection Agency

ER Expert Reviewer

FR Federal Register

HENC High Efficiency Neutron Counter

INL Idaho National Laboratory

LLD Lower Limit of Detection

NCR Nonconformance Report

NDA Nondestructive Assay

NDE Nondestructive Examination

PDP Performance Demonstration Program38

QA Quality Assurance

QAO Quality Assurance Objective

QAPjP Quality Assurance Project Plan

QC Quality Control

RFETS Rocky Flats Environmental Technology Site

RH Remote-Handled

RTR Real-Time Radiography

SCG Summary Category Groups

SME Subject Matter Expert

SOP Standard Operating Procedure

T1 Tier 1

T2 Tier 2

TGS Tomographic Gamma Scanner

TMU Total Measurement Uncertainty

TRU Transuranic

TWBIR Transuranic Waste Baseline Inventory Report

VE Visual Examination

VEE Visual Examination Expert

VET Visual Examination Technique

WAC Waste Acceptance Criteria

WAP Waste Analysis Plan

WC Waste Characterization

WCO Waste Certification Official39

WIPP Waste Isolation Pilot Plant

WMC Waste Matrix Code

WMP Waste Material Parameter

WSPF Waste Stream Profile Form

WWIS WIPP Waste Information System