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 2006 
Disclaimer 

This document is intended solely as a guide providing 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 binding and EPA officials may decide to 

follow the guidance, or act at variance with the guidance, based on an analysis of specific 

circumstances. The EPA reserves the right to update this document as needed to reflect changes 

that may be necessary as the Agency verifies regulatory 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 Inspections .................................. 6 

3.0 Performance of Site Inspection......................................................................................... 11 

4.0 Preparation of Draft and Final Inspection Reports by EPA and the Public 

Participation Process......................................................................................................... 13 

4.1 Tiering of Waste Characterization Components................................................... 14 

4.2 Seeking Public Comment on Proposed Approval Decision ................................. 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......................................... 28 

6.1 Tier 1 Changes ...................................................................................................... 28 

6.2 Tier 2 Changes ...................................................................................................... 31 

6.3 Waste Characterization Program Changes Not Requiring 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 .................................................................... 37 
ii 

LIST OF FIGURES 

Figure 1. Summary of Baseline Compliance Decision Process......................................................4 

Figure 2. Site Baseline Process — Pre-Inspection Activities.......................................................10 

Figure 3. Site Baseline Inspection Process and Compliance 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 ......................................................... 15 
1 

1.0 INTRODUCTION 

This document provides guidance on the process that the U.S. Environmental Protection Agency 

(EPA) uses to conduct waste characterization (WC) program 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 (WIPP). EPA believes that this guidance will 

assist the Carlsbad Field Office (CBFO) and TRU waste generator sites in preparing for EPA 

inspections and approvals. In October 2004, EPA promulgated changes to EPA’s site inspection 

and approval process at 40 CFR 194.8 (see 69 FR 42571). These changes require EPA to 

conduct baseline inspections at all EPA-approved TRU 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 guidance to develop a baseline approval 

regarding the acceptability of WC programs and processes 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 verify TRU sites’ compliance with the WIPP 

Compliance Criteria. 

1.1 Regulatory Background 

Section 194.24 requires that all waste characteristics, such as solubility, ability to generate gas, 

formation of radionuclide-bearing colloids, sheer strength 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 metals, cellulosics, chelating agents, water 

and other liquids, and curie activity of each radionuclide are also assessed. Methods used to 

quantify the limits on waste components must be described. EPA is authorized to use 

inspections, audits, and record reviews to verify compliance with §194.24 requirements 

described above. 

On May 18, 1998, EPA issued a decision certifying that the WIPP complies with EPA’s 

radiological waste disposal regulations. As part of 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) specified 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 characterizing 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 Process for Waste Shipment from Waste 

Generator Sites for Disposal at the WIPP”). Section 194.8(a) and §194.8(b) address quality 

assurance (QA) programs and WC programs at TRU waste generator sites, respectively. 

On July 16, 2004, EPA amended §194.8(b) (69 FR 42571, “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”). The impetus for these changes was the result of 

EPA’s waste characterization experience for the past five years where EPA had to publish a 
2 

Federal Register (FR) notice. That is, any time approved 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 original site approval process sought public 

comment on DOE’s upper tier documents implemented by a site being inspected but not on the 

WC program approval decision. Consistent with 69 FR 42571, this revision maintains or 

improves EPA’s oversight at WIPP to ensure safe disposal of waste. The purpose of this 

guidance is to describe how the revised §194.8(b) is 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 inspection and documentation provided by the TRU 

waste sites, EPA determines that the site WC programs and processes meet the requirements of 

40 CFR 194.8(b), EPA will announce its intent to approve the site’s WC program (the Baseline 

Compliance Decision) in the Federal Register and solicit comments for a period of at least 

45 days. The FR notice will describe EPA’s proposed approvals and the requirements for 

reporting any future changes to the approved baseline programs. 

The basic steps in issuing a Baseline Compliance Decision 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 an inspection to prepare checklists to 

assess the site’s compliance with the EPA requirements that are incorporated in DOE’s WIPP 

Waste Acceptance Criteria (WAC). 

(3) EPA conducts a baseline compliance inspection at the 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 technical 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 relevant WC processes, including the 

following: 

• Verification that each site performing characterization of TRU waste can quantify the 

amount of each waste component emplaced at WIPP, and 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 for 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 conduct additional inspections to ensure that 

the identified deficiencies are corrected. 

(6) If EPA determines that the site meets the requirements 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 inspection report. The proposed Baseline 

Compliance Decision will identify any limitations on approved waste streams or WC 

processes. In addition, the notice will specify how 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 on 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 report 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. 
4 

Figure 1. Summary of Baseline Compliance Decision Process 

DOE provides notification letter and 

documentation of site readiness

EPA requests additional documentation 

EPA conducts site Baseline Compliance Inspection* (*see last paragraph under Section 2.0)

EPA rejects DOE request for site approval 

EPA send

 to Public 

DOE provides additional 

documentation 

EPA conducts additional site 

inspection(s) 

EPA announces proposed Baseline Compliance Decision in FR. EPA identifies through tier designations how fu

in waste characterization processes are to be implemented. EPA sends draft reports and tier designations to Pub

EPA solicits public comments and amends compliance decision as appropriate 

EPA sends notice of Compliance Decision to DOE 

(available from EPA Docket and website) 

EPA may request 

additional information
5 

2.0 PRE-INSPECTION ACTIVITIES 

This section describes those activities that are expected 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 triggered per §194.8(b)(2)(i), which states the 

following: 

DOE will notify EPA by letter that a transuranic waste site is prepared to ship 

waste to the WIPP and has established adequate waste characterization processes 

and programs. DOE will also provide the relevant waste characterization 

program plans and documentation. EPA may request additional information 

from DOE. 

As described above, the Site/CBFO is required to notify 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 soils that would be generated in the future, but 

would be prepared to characterize debris or solid waste currently in storage. Accordingly, the 

letter notification would specify any such limitations 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 identify any site-specific nondestructive assay 

(NDA) or nondestructive examination (NDE) instrumentation 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 in place an EPA-approved QA program. When 

the stored wastes are retrieved for characterization prior to disposal at WIPP, the characterization 

must occur under an EPA approved program, irrespective 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 EPA 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 particularly useful to examine as much relevant 

information as possible prior to site inspections in 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 from the list are required for the baseline 

compliance inspection. 

EPA baseline and follow-up inspections might not occur at the same time that CBFO is 

conducting its QA audits at DOE sites. In such cases, CBFO observers may be present during 

EPA inspections. The presence of CBFO observers can facilitate conveying of information to 
6 

CBFO regarding issues raised by EPA during an inspection, 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 issues. 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 sites and EPA may opt to be present at these 

audits as observers or perform concurrent inspections. 

2.1 Documents and Records Required for Baseline Inspections 

EPA expects documentation requested by the Agency be 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 included in the baseline inspection (e.g., S5000 

retrievably-stored debris—direct loaded, uncompacted; S5000 newly-generated debris—

compacted; S3000 retrievably-stored solids—direct loaded, uncompacted), and the specific 

instruments and/or measurement systems the site proposes to use for WC. 

Examples of documentation that might be required for review prior to the baseline inspection are 

listed below by technical areas relevant to WC. This list is not comprehensive but indicates the 

types of documents EPA may need in preparing checklists to evaluate processes, procedures, and 

equipment during the inspection. Other documentation 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 and plans 

• Solid sampling procedures or plans, if this includes 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 managed at the facility that will be 

included in an inspection 

• Container list showing containers in each example waste stream available for EPA 

inspectors to select drums for traceability analysis, and characterization status of these 

containers (i.e., showing containers completely through the characterization process, 

partially through, etc.) 

• Documentation supporting the absence of radiological data in the AK summary 

• AK road map (reference list) for each example waste stream 
7 

• Completed example Waste Stream Profile Form (WSPF) and Characterization 

Information Summary (CIS) for each example waste stream 

• 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 detection (LLD) for each instrument 

within the inspection’s scope 

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

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

• Anticipated status of each instrument at time of (or 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 operation and data recording 

• Procedure(s) used for training and qualification of radiography operators and subject 

matter experts (SMEs), however named, including a list of training container 

requirements 

• List of currently-qualified radiography operators and SMEs 

• Procedure(s) used for radiography data review and validation (data generation and project 

level) 

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

• Procedure(s) that addresses records retention for radiography
8 

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 recording 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 validation (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 miscertification rates 

 

WIPP Waste Information System (WWIS)

• Procedure(s) that address data entry, review, correction, 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 and WCOs 

Other Documentation

• TRU Waste Quality Assurance Project Plan (QAPjP) 

• TRU Waste Certification Plans 

• Training and Qualification Plan 

• Project-level data validation and verification procedures or plans 

• QA procedures or plans related to software 
9 

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

• Data Quality Objectives (DQO) reconciliation-related 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-specific 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 deadline in electronic format, when available. 

If revisions are made to other procedures or documents 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 requested should be provided to EPA within a 

week after receipt of the request. For example, review 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 to the site inspection. If EPA is not provided 

with the requested documentation during the time specified in the EPA request, the Agency may 

need to delay its inspection to ensure that the necessary material is provided and reviewed prior 

to the site inspection. 

The major steps in the pre-inspection process are summarized in Figure 2, Site Baseline 

Process — Pre-Inspection Activities. 
10 

Figure 2. Site Baseline Process — Pre-Inspection Activities

DOE Notifies EPA of Site Readiness 

DOE Provides List of Plans and Documentation 

DOE and EPA 

Establish Inspection Date

EPA Drafts Letter for Inspection and Identifies 

Information Needs and Requests Information

EPA Requests 

Information

No 

Yes

No 

No

Yes 

1 Inspection based on pro

revisions provided two winspection. EPA discretichanges made less than 2 to Inspection date. 

2 Appropriate means the 

consistent with EPA’s readequate to support the pinspection checklists.

Yes 

Establish New 

Inspection Da

EPA Proceeds with Site Inspection 

Documents1

Received 

Two Weeks 

Prior? (Y/N)

DOE Provides 

Additional 

Information? 

(Y/N) 

Documents 

Complete and 

Appropriate2? 

(Y/N)
11 

3.0 PERFORMANCE OF SITE INSPECTION 

• Specifics of how the inspection will be performed and 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, proposed 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 inspection 

• Requests for other items, if appropriate 

• Logistics for replicate testing 

• Specifics of how EPA will identify issue(s) of noncompliance and resolution pathway 

(i.e., how issues identified during the inspection will be tracked and resolved): 

− Issue identified by the EPA inspector during the inspection 

− Discussion among EPA inspection team, and initiation of an EPA Inspection Issue 

Tracking Form 

− If necessary, perform further investigation to clearly define the extent of the 

noncompliance identified 

− Collect objective evidence of noncompliance 

− Discuss contents of the EPA Inspection Issue Tracking Form with relevant onsite 

personnel 

− Identify EPA regulatory requirement not met 

− If issue is assessed to be insignificant, inform the site personnel that a finding/concern 

form will not be issued 

− Provide an explanation of why the issue was assessed as being insignificant to site 

personnel 
12 

− 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 expects site’s response to a 

finding or concern 

− EPA inspector completes an EPA Inspection Issue Tracking 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) to address EPA issue and 

resolution deadline before the EPA closeout meeting

− If the site provides objective evidence of corrective action during the onsite 

inspection, the EPA inspector will evaluate the site’s response to determine if the 

finding/concern was adequately addressed and documented 

− If the determination is that the finding/concern was successfully resolved, the 

inspector collects and inventories the objective evidence for inclusion in the 

inspection report 

− EPA informs the site that the finding/concern was successfully resolved 

− If the inspector’s determination is that either the corrective action implemented or the 

objective evidence presented by the site is insufficient 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 EPA 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 specific 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 that a specific 

item or activity may or may not have a negative effect on compliance and, depending on the magnitude of the issue, 

may or may not require a response.
13 

4.0 PREPARATION OF DRAFT AND FINAL INSPECTION REPORTS BY EPA 

AND THE PUBLIC PARTICIPATION PROCESS 

This section describes the process that EPA will use to arrive at a Baseline Compliance Decision 

and announce its decision in draft and final baseline 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 documentation in the public 

docket described in §194.67. The site inspection report supporting the proposal 

will describe any limitations on approved waste streams or waste 

characterization processes. It will also identify (through tier designations in 

accordance with paragraph (b)(4) of this section) what changes to the approved 

waste characterization processes must be reported to 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 Compliance Decision, including 

any limitations and the tier designations for future changes or expansions to the 

site’s waste characterization program. 

As described in §194.8(b)(2)(iii) above, EPA will prepare a draft site inspection report(s) 

supporting its proposed Baseline Compliance Decision. The inspection report includes all 

findings and concerns identified during the inspection 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 in 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 conclusions and request public comment. The draft 

site inspection report and any supporting documentation 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 reports 

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

• Waste container and batch data reports (BDRs) reviewed 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 technical area 
14 

• 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 program will be reported to EPA after 

the EPA approval 

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

changes 

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

4.1 Tiering of Waste Characterization Components 

A key element of the Baseline Compliance Decision is 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 Inspection Report. 

EPA’s proposed Baseline Compliance Decision will designate 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 designated as T1 changes. Changes made to improve 

WC processes and do not alter implementation of approved WC components are viewed as T2 

changes. Other site-specific conditions could dictate a tiering designation that differs from the 

above criteria. T1 changes require CBFO/Site to obtain written EPA approval of the 

change/addition prior to implementation of the change. T2 changes require CBFO/Site to notify 

EPA in writing of the change according to the schedule established in the report, i.e., quarterly, 

but EPA approval is not required prior to the implementation 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 not 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 elements as we conduct more baseline 

inspections. 

EPA considers site-specific upper tier documents such as the TRU Waste Certification Plan and 

Quality Assurance Project Plan (QAPjP) to be critical to the characterization of TRU wastes. 

Accordingly, EPA requires notification regarding all changes to these documents with the 

potential to impact TRU WC activities within EPA’s purview. 

Proposed changes to WC processes, procedures, or equipment will be assigned T1 or T2 status 

depending on the type of waste(s) evaluated, limitations of assay or measurement equipment, and 

adequacy of procedure(s). EPA will make tiering assignments 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 and 
15 

T2 reporting requirements unique to each site in the site inspection report supporting the 

Baseline Compliance Decision (§194.8(b)(2)(iii)). 

During the baseline inspection process, each site provides a list of TRU WC personnel from 

which EPA selects a few individuals to be interviewed. The EPA inspectors review the 

qualifications and training records of these individuals 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 TRU waste to ensure that they are well 

qualified and have received adequate training to perform their assigned function. EPA may 

review the training and qualifications of the key WC personnel at any time. EPA may conduct 

periodic records reviews and interviews of WC personnel 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 Documentation 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 documents 
16 

Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Documentation 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 Documentation 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 approved 

SCG, 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 for 
18 

Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Documentation 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 - Procedure 

- 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 

- Resume 
19 

Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Documentation 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 Examination 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 Documentation 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 

change 
21 

Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Documentation 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 and 

detection 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, container 

staging, 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, and 

detection 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, and 

detection capability for 10 WIPPtracked radionuclides 
22 

Table 1. Potential T1 and T2 Elements by Technical Area

Item Description of Change Example of Change Documentation 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., NCRs 
23 

4.2 Seeking Public Comment on Proposed Approval Decision 

The changes to §194.8 modified the public participation process significantly with respect to 

when the public may comment and the type of material 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 public comment. Public comments were then 

assessed and included in the final inspection report 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 pertinent material supporting this determination. 

The public will be allowed at least 45 days to examine EPA’s proposed approvals and to submit 

written comments to EPA for consideration. EPA will include responses to comments in the 

final inspection report. EPA may also revise the draft inspection report in response to issues or 

comments raised by the public. The final inspection report will be placed in the public docket. 

In each final report, EPA will establish the specific reporting requirements for information 

pertaining to T1 and T2 changes. 

A summary of the steps involved in conducting a baseline site inspection are illustrated in 

Figure 3, Site Baseline Inspection Process and Compliance Decision. 
24 

Figure 3. Site Baseline Inspection Process and Compliance 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

Issues1

 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 request can be sent to EPA at any time after 

baseline approval. EPA approval is necessary before the site can implement a T1 change and 

begin to dispose of the waste characterized using the proposed change. When submitting a 

proposed T1 change, EPA prefers that the site provide relevant documentation supporting the 

proposed change in electronic format. Upon review of the initial submission, EPA may request 

additional information. Once all necessary information has been received, EPA will make an 

adequacy determination and will issue a decision letter. EPA will post any approval decisions on 

its website including EPA’s analysis of the T1 change and information supporting the T1 change 

that was provided by the site. 

Further, for T1 changes, EPA will amend the final report, either through revision of text or by 

including an attachment detailing the amendment, and the revised report will be docketed. EPA 

will also docket and post (on the EPA website) information from any §194.24(h) inspection 

performed. 

Reporting of T2 Changes to EPA

Once a site has been approved via the baseline inspection process, EPA expects that the site will 

submit quarterly (or at another schedule established 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 baseline approval the of site’s WC 

program 

• EPA encourages CBFO/Site to consult with EPA if they are unsure about the tier level 

for a change that is not covered in the Baseline Compliance Decision 

• Complete reports, including the site contact name and numbers, will be submitted by the 

Site/CBFO 

• EPA encourages the Site/CBFO to develop a format for 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 number (and Revision) and the FTP 

site where it is available 

• EPA will assign an EPA tracking number for the change request 
26 

• 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 eliminate the Agency’s opportunity to identify 

issues either within or after the tiering process described in this document. The Federal Register, 

Volume 69, page 42577 states the following: 

If, at any time, we [EPA] determine[d] that the system 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 those waste streams or processes at 

the WIPP until the Agency’s findings have been adequately resolved. 

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

Subsequent to any positive determination of compliance as described in 

paragraph (b)(2)(iii) of this section, EPA may revise the tier designations for 

approving changes or expansions to the waste characterization 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 notification and approval 

requirements (e.g., from Tier 2 to Tier 1, or from undesignated to Tier 

2), the change shall become effective immediately and the site shall 

operate under the more stringent requirements without delay. 

(iii) If the revised designation entails less stringent notification and approval 

requirements (e.g., from a Tier 1 to Tier 2, or from Tier 2 to 

undesignated), EPA will solicit comments from the public for a minimum 

of 30 days. The site will continue to operate under the more stringent 

approval requirements until the public comment period is closed and 

EPA notifies DOE in writing of the Agency’s final decision. 

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 changes 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 also provide electronic updates to the WIPPNEWS e-mail service, which sends e-mail notifications regarding EPA and the WIPP to 

subscribers (see the previous Web address for subscription link). Hard copies of information 
27 

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 FROM DOE 

Section 194.8(b)(4) describes how DOE can make changes 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 compliance as described in 

paragraph (b)(2)(iv) of this section, the Department must report changes or 

expansions to the approved waste characterization program at a site in 

accordance with the tier designations established in the Baseline Compliance 

Decision. 

(i) For changes or expansions to the waste characterization program 

designated as “Tier 1,” the Department shall provide written 

notification to the Agency. The Department shall not ship for disposal at 

WIPP any waste that has been characterized using the 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 characterization program 

designated as “Tier 2,” the Department shall provide written 

notification to the Agency. Waste characterized using 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 expansions 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 notifications 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 either provide information specified in the 

Baseline Compliance Decision or include all information 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 select candidates for replicate 

measurements). EPA will assess the information provided 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 waste from a SCG, outside of that previously 

approved by EPA in its Baseline Compliance Decision, it is likely that EPA will request 
29 

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 inspection 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 technical evaluation within three weeks of 

determining that all information required to perform the technical analysis has been provided. 

EPA, at its discretion, may choose to conduct inspections 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 comparable to the initial baseline inspection, 

but with a scope limited to the technical aspects pertinent to the specific T1 change proposed. 

Alternately, EPA may choose to evaluate the proposed T1 change by performing a desk-top 

review. This typically consists of DOE supplying documents 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 additional information, and EPA expects that 

DOE will provide all needed materials and facilitate all required communication. EPA shall 

determine and apply the appropriate mechanism for evaluating a proposed T1 change at its 

discretion. A summary of the procedure for evaluating a T1 process proposed by DOE is 

illustrated in Figure 4, Tier 1 Evaluation. 
30 

Figure 4. Tier 1 Evaluation 

Is Modification 

Qualified for 

Tier 1? (Y/N) 

Discuss Tier Status 

With DOE 

Notify DOE Changes Can Be Implemented 

No 

Yes 

Yes 

Yes 

Discuss Tier 1 Submittal 

With DOE 

Discuss Tier 1 Submittal With DOE – 

(Disapprove or Resubmit) 

Disapprove Modification 

No

No

Resubmit 

Resubmit

Docket Decision, Post on Website 

Is Change 

Qualified for 

Tier 1? (Y/N)

Is Tier 1 

Submittal 

Complete? 

(Y/N) 

Is 

Tier 1 

Submittal Technically 

Acceptable? (Y/N) 

Perform Desk-top Review 

and/or Onsite 

Inspection 

Yes 
31 

6.2 Tier 2 Changes 

T2 actions are described in §194.8(b)(4)(ii). T2 changes can be implemented without EPA’s 

prior approval. However, for EPA to be aware of the T2 changes implemented, EPA requires the 

Site/CBFO report all T2 changes quarterly (or another 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 site to notify EPA when they occur, but do not 

require EPA approval before they are undertaken. EPA’s Baseline Compliance 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 identifies the Baseline Compliance Decision 

relevant to the proposed T2 change. 

EPA will compare the T2 submission contents with the requirements presented in the Baseline 

Compliance Decision to ensure that all required information has been submitted and that the 

submission is categorized appropriately (i.e., T2 vs. 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 lacking and will request the missing information by 

a specified date. EPA will also examine the contents of the submission to determine whether any 

technical information within the submission requires additional documentation or information to 

fully understand the technical element and its potential impact on WC. If questions arise, EPA 

will send a letter to CBFO requesting information beyond 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 obtained, 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 determination 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 determine whether any supporting information is 

necessary for EPA to fully understand the submission (e.g., a more detailed AK document than 

that provided with the WSPF). EPA would also review the WSPFs to see whether they are 

within the approved SCGs. 

EPA will communicate with CBFO/Site regarding questions 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 conduct 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 results of its evaluation, which will be 

docketed. Figure 5 illustrates the steps in a T2 evaluation. 
32 

Figure 5. Tier 2 Evaluation 

Yes 

Yes 

Notify DOE that Changes are Acceptable 

Info

Im

Notify DOE that Changes are Acceptable 

Resubmit

No 

No

Resubmit 

No 

No 

Yes 

Yes 

Docket Decision 

Disapprove Modification

Discuss Tier Status 

with DOE

Discuss Tier 2 Submittal 

with DOE 

Discuss Tier 2 Submittal 

with DOE – 

(Disapprove or Resubmit) 

Is 

Change 

Qualified for 

Tier 2? 

 (Y/N)

Is Tier 2 

Submittal 

Complete? 

(Y/N) 

Is 

Modification 

Qualified for 

Tier 2? 

(Y/N)

Is Tier 2 

Submittal 

Technically 

Acceptable? 

(Y/N)
33 

6.3 Waste Characterization Program Changes Not Requiring 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 Site/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. In such cases, EPA recommends that 

CBFO/Site contact the Agency with any questions regarding changes that do not appear to be 

covered by existing T1 or T2 designations. This would 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 language shall be clear and precise. For 

example, if a site is approved for additional WC activities 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 shipment of newly generated 

S3000 and S5000 wastes derived from Pit 4. Shipment of wastes from these 

categories is now a T2 change, requiring provision of Department-approved 

waste stream profile forms to EPA every three months. 

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 regarding a technical element or issue, or a 

certain issue cannot be resolved in a timely fashion, 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. 
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7.0 OTHER 

In its rulemaking promulgating 194.8 changes, EPA established a process under 

40 CFR 194.8(b)(6) which allows the previously approved sites to continue to characterize and 

dispose of approved waste streams at WIPP until a baseline compliance decision is established. 

The TRU sites without any prior EPA approval will be 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. 63, No. 95, May 18, 1998). 

The baseline inspection and approval process discussed in this guidance also applies to TRU 

waste sites managing and characterizing remote-handled (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 approve 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 inspection 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 determination. After completing the 

baseline inspection, EPA will prepare a report summarizing the inspection process, the results of 

the inspection(s), and the proposed approval decision. The public will have 45 days to comment 

on the proposed approval decision. Upon consideration 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 27354–27406, 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 Protection Standards for Management and 

Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes.” 

U.S. Environmental Protection Agency, Code of Federal Regulations, Title 40, “Protection of 

Environment,” Part 194, “Criteria for the Certification 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 Application 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 for the Baseline Inspection of the INL CCP, 

Docket No: A-98-49; II-A4-59. 

U.S. Environmental Protection Agency Draft/Final Report 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 Program 
38 

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 Official 
39 

WIPP Waste Isolation Pilot Plant 

WMC Waste Matrix Code 

WMP Waste Material Parameter 

WSPF Waste Stream Profile Form 

WWIS WIPP Waste Information System