[Federal Register Volume 69, Number 136 (Friday, July 16, 2004)]
[Rules and Regulations]
[Pages 42571-42583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16207]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 194

[FRL-7787-6]
RIN 2060-AJ07


Criteria for the Certification and Recertification of the Waste 
Isolation Pilot Plant's Compliance With the Disposal Regulations; 
Alternative Provisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (``EPA'' or ``the Agency'' 
or ``we'') is finalizing changes to the ``Criteria for the 
Certification and Recertification of the Waste Isolation Pilot Plant's 
Compliance with the Disposal Regulations,'' (``Compliance Criteria'') 
proposed August 9, 2002 (67 FR 51930-51946). Today, after considering 
public comments received in response to the proposed changes, we 
finalize the following actions: Addition of a mechanism to address 
minor changes to the provisions of the Compliance Criteria; changes to 
the approval process for waste characterization programs at Department 
of Energy (DOE) transuranic (TRU) waste sites; changes to the number of 
copies of compliance applications and reference materials submitted to 
EPA; and replacement of the term ``process knowledge'' with 
``acceptable knowledge.'' Today's action will maintain or improve our 
oversight at WIPP to ensure safe disposal of waste. Moreover, these 
changes do not modify the technical approach that EPA employs when 
conducting independent inspections of the waste characterization 
capabilities at DOE waste generator/storage sites. EPA is conducting 
this action in accordance with the procedures for substituting 
alternative provisions in the Compliance Criteria.

DATES: This final rule is effective October 14, 2004.

FOR FURTHER INFORMATION CONTACT: Ray Lee; telephone number: (202) 343-
9463; postal address: Radiation Protection Division, Mail Code 6608J, 
U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460.

SUPPLEMENTARY INFORMATION:

I. General Information

A. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under Docket ID No. OAR-2002-0005. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at: 
Air and Radiation Docket and Information Center, Room B-108, U.S. 
Environmental Protection Agency, 301 Constitution Ave., NW., 
Washington, DC. This Docket Facility is open from 8:30 a.m.-4:30 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (202) 566-1742.
    2. Electronic Access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, 
access the index listing of the contents of the official public docket, 
and to access those documents in the public docket that are available 
electronically. Although not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B. 
Once in the system, select ``search,'' then key in the appropriate 
docket identification number (OAR-2002-0005 for this action).

Abbreviations Used in This Document

AK--Acceptable Knowledge
ANL-E--Argonne National Laboratory-East
APA--Administrative Procedure Act
BID--Background Information Document
CBFO--Carlsbad Field Office
CFR--Code of Federal Regulations
CH--Contact Handled
DOE--Department of Energy
EPA--Environmental Protection Agency
INEEL--Idaho National Energy and Engineering Laboratory
LANL--Los Alamos National Laboratory
NDA--Nondestructive Assay
NPRM--Notice of Proposed Rulemaking
NRC--Nuclear Regulatory Commission
NTS--Nevada Test Site
ORNL--Oak Ridge National Laboratory
PK--Process knowledge
RFETS--Rocky Flats Environmental Technology Site
RTR--Real-time radiography
SRS--Savannah River Site
TRU--Transuranic
VE--Visual inspection
WC--Waste characterization
WIPP--Waste Isolation Pilot Plant
WIPP LWA--WIPP Land Withdrawal Act
WWIS--WIPP Waste Information System

Table of Contents

I. What is the WIPP?
II. What changes did EPA propose?
    A. Proposed changes to Sec.  194.6--process for adding minor 
alternative provisions
    B. Proposed changes to Sec.  194.8(b)--waste generator site 
inspection and approval process
    C. Proposed changes to Sec. Sec.  194.12 and 194.13--number and 
form of DOE compliance applications and reference materials
    D. Proposed changes to Sec. Sec.  194.2 and 194.24(c)(3)--
terminology related to waste characterization
III. What is EPA's final action in consideration of public comments?
    A. Summary of comments and final changes to Sec.  194.6--process 
for adding minor alternative provisions
    B. Summary of comments and Final changes to Sec.  194.8(b)--
waste generator site inspection and approval process
    C. Summary of comments and final changes to Sec. Sec.  194.12 
and 194.13--number and form of DOE compliance applications and 
reference materials
    D. Summary of comments and final changes to Sec. Sec.  194.2 and 
194.24(c)(3)--terminology related to waste characterization
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866
    B. Congressional Review Act
    C. Regulatory Flexibility Act
    D. Paperwork Reduction Act
    E. Unfunded Mandates Reform Act
    F. Executive Order 12898
    G. National Technology Transfer & Advancement Act of 1995
    H. Executive Order 13045: Children's Health Protection

[[Page 42572]]

    I. Executive Order 13132: Federalism
    J. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    K. Executive Order 13211: Energy Effects

I. What Is the WIPP?

    The Waste Isolation Pilot Plant (``WIPP'') is a disposal system for 
transuranic (TRU) radioactive waste. Developed by the Department of 
Energy (``DOE'' or ``the Department''), the WIPP is located near 
Carlsbad in southeastern New Mexico. TRU waste is emplaced 2,150 feet 
underground in an ancient layer of salt that will eventually ``creep'' 
and encapsulate the waste containers. The WIPP has a total capacity of 
6.2 million cubic feet of TRU waste. Most TRU waste proposed for 
disposal at WIPP consists of items that have become contaminated as a 
result of activities associated with the production of nuclear weapons 
(or with the cleanup of nuclear weapons production facilities), such 
as, rags, equipment, tools, protective gear, and sludges. Some TRU 
waste is contaminated with hazardous wastes regulated under the 
Resource Conservation and Recovery Act (42 U.S.C. 6901-6992k) 
(``RCRA''). The waste proposed for disposal at WIPP is currently stored 
at Federal facilities across the United States, including locations in 
Colorado, Idaho, New Mexico, Nevada, Ohio, South Carolina, Tennessee, 
and Washington.
    The WIPP must meet EPA's generic disposal standards at 40 CFR part 
191 for high-level and TRU radioactive waste. These standards establish 
numeric limits to ensure that the WIPP effectively contains radioactive 
waste. To determine whether the WIPP performs well enough to meet these 
disposal standards, EPA issued the WIPP Compliance Criteria (40 CFR 
part 194) in 1997. The Compliance Criteria interpret and implement the 
disposal standards specifically for the WIPP site. They describe what 
information DOE must provide, how EPA evaluates the WIPP's performance, 
and provides ongoing independent oversight.
    Using the process outlined in the WIPP Compliance Criteria, EPA 
determined on May 18, 1998, that DOE had demonstrated that the WIPP 
complied with EPA's radioactive waste disposal regulations at subparts 
B and C of 40 CFR part 191. EPA's certification determination permitted 
the WIPP to begin accepting transuranic waste for disposal, provided 
that other applicable environmental regulations were met. Also, the 
disposal of TRU waste at WIPP is conditioned on the EPA determination 
that activities conducted at waste generator sites appropriately comply 
with the quality assurance (QA) and waste characterization (WC) 
requirements established at Sec.  194.22 and Sec.  194.24, 
respectively. (For a detailed discussion on all of the proposed 
changes, see 67 FR 51930-51946; August 9, 2002.)

II. What Changes Did EPA Propose?

    On August 9, 2002, EPA proposed to revise certain provisions of the 
Compliance Criteria at 40 CFR part 194. Specifically, EPA proposed to 
revise the following: (1) Process for establishing ``alternative 
provisions'' in Sec.  194.6; (2) approval process in Sec.  194.8 for 
waste characterization processes at TRU waste generator/storage sites 
used to characterize TRU waste prior to its disposal at WIPP; (3) 
requirements in Sec. Sec.  194.12 and 194.13 for submission of 
compliance applications and reference material; and (4) replace the 
term ``process knowledge'' with ``acceptable knowledge'' in Sec. Sec.  
194.2 and 194.24(c)(3). The proposed revisions intend to ensure that 40 
CFR part 194 remains comprehensive, appropriate, and is based upon 
current knowledge and information. The Agency solicited comments on 
this proposal over a period of 120 days. In addition, in September 
2002, EPA held public hearings at Albuquerque and Santa Fe, New Mexico. 
The transcripts of the hearings have been placed in the EPA Docket 
supporting this final action (EDOCKET ID: OAR-2002-0005).

A. Proposed Changes to Sec.  194.6--Process for Adding Minor 
Alternative Provisions

    Section 194.6 establishes procedures applicable to substitution of 
alternative provisions for any of the Compliance Criteria. Such 
substitutions require a notice-and-comment rulemaking in accordance 
with Sec.  194.6(a). In addition, Sec.  194.6 stipulates that EPA's 
notice of proposed rulemaking (NPRM) addresses specific aspects of the 
proposed substitution, includes a public comment period of at least 120 
days, and public hearings in New Mexico.
    Based on EPA's oversight experience at the WIPP and TRU waste 
generator/storage sites, EPA proposed to revise Sec.  194.6 to add a 
rulemaking process for substituting ``minor alternative provisions'' of 
the Compliance Criteria. The proposed changes for Sec.  194.6 comport 
fully with the radioactive waste disposal regulations at 40 CFR part 
191 and would not substantively alter the scope of the TRU waste 
disposal requirements. EPA also proposed to add to Sec.  194.2 the 
definition of ``minor alternative provision'' to be a provision that 
clarifies a regulatory provision without substantively altering the 
existing regulatory requirement. Thus, revisions that do not alter the 
intent or the approach to verifying compliance of an existing 
regulatory requirement would be considered ``minor alternative 
provisions.''

B. Proposed Changes to Sec.  194.8(b)--Waste Generator Site Inspection 
and Approval Process

    The information outlined in Sec.  194.8 describes the process by 
which EPA inspects and approves waste characterization (WC) activities 
at TRU waste sites. (For a detailed discussion, see 67 FR 51934-38.) 
Previously, every time a TRU waste site sought approval of its WC 
processes or TRU waste stream(s), EPA was required to conduct a site 
inspection under the authority of Sec.  194.8. The Sec.  194.8 process 
required EPA to issue a Federal Register notice announcing an 
inspection, open a 30-day public comment period, and docket WC-related 
material provided by the site for public review. The same process was 
required to approve all subsequent expansions of the WC program to new 
processes or waste streams at a site. Instead, we proposed that EPA 
will conduct only a single baseline site inspection under Sec.  194.8 
to determine whether a given site can adequately characterize TRU waste 
and comply with the regulatory requirements imposed on the TRU waste 
destined for the disposal at WIPP. Also, we proposed that all 
additional inspections at an approved site would be conducted under 
authority of Sec.  194.24(h) (not under Sec.  194.8) to approve changes 
or expansions to the WC processes and waste streams approved during the 
initial site approval referred to as the ``Baseline Compliance 
Decision.'' (See discussion in IV.B below.) The second key change we 
proposed was giving the opportunity for public comment on EPA's 
proposed approval of the site's waste characterization program. The 
proposed approval and accompanying inspection report would discuss 
inspection results and the waste characterization program documentation 
provided by the site. In addition, we proposed that the Agency would 
issue a final approval decision only after consideration of the public 
comments received in response to the proposed site approval.
    EPA will issue a single Federal Register notice after each of the 
initial baseline inspections. The public will be asked to comment on 
the proposed approval and reporting requirements for each of the waste 
generator sites. The results of all EPA site inspections (under Sec.  
194.8 and Sec.  194.24) and other

[[Page 42573]]

relevant information/updates will be made available to the public in 
EPA's dockets, WIPP Web site, and other means. We determined that the 
revised process provides equivalent or improved oversight, more control 
over schedule, better prioritization of technical issues and 
distinctions, and flexibility to address relative levels of experience 
or expertise at various DOE sites.

C. Proposed Changes to Sec. Sec.  194.12 and 194.13--Number and Form of 
DOE Compliance Applications and Reference Materials

    Section 194.12 of the Compliance Criteria requires DOE to submit 30 
copies of the compliance applications and any accompanying materials to 
the Administrator in printed form. This provision also applies to the 
compliance applications periodically submitted by DOE for re-
certification of compliance. Section 194.13 requires that 10 printed 
copies of referenced materials be submitted to the Administrator, 
unless such materials are generally available.
    We proposed to revise Sec.  194.12 to change the number of printed 
copies of compliance applications and reference materials that DOE must 
submit to EPA. We proposed to reduce the number of hard copies from 30 
to 5 (one original and four printed copies). In addition, the proposed 
revisions Sec.  194.12 required that DOE submit 10 complete compliance 
applications by alternative means (e.g., compact disk) or other 
approved format. Also, the Agency proposed to revise Sec.  194.13 by 
changing the number of copies in printed form of the reference 
materials from 10 to 5 and to require DOE to submit 10 copies of 
reference materials by alternative means (e.g., compact disk) or other 
approved format. We determined that the proposed revisions for 
Sec. Sec.  194.12 and 194.13 would (a) improve the Agency's evaluation 
process and reduce costs associated with the review of compliance 
applications and reference materials; (b) enhance the public's access 
to information via Internet ability to participate more actively in the 
public comment process; and (c) reduce the number of copies in printed 
form that must be submitted, thereby reducing paper usage.

D. Proposed Changes to Sec. Sec.  194.2 and 194.24(c)(3)--Terminology 
Related to Waste Characterization

    The Agency proposed to revise Sec.  194.24(c)(3) by replacing the 
term ``process knowledge'' with the term ``acceptable knowledge.'' The 
term ``acceptable knowledge'' has been used by EPA and DOE since the 
Department submitted the Compliance Certification Application, during 
both the certification rulemaking and subsequent site inspections. For 
consistency, the Agency also proposed to add the definition of 
``acceptable knowledge'' to Sec.  194.2.

III. What Is EPA's Final Action in Consideration of Public Comments?

    Over the 120-day comment period for the proposed rule, EPA received 
17 sets of comments (7 from the public hearings, 4 from EDOCKET, and 6 
through e-mail/regular mail). During the two public hearings held in 
Albuquerque and Santa Fe, New Mexico, 7 individuals presented their 
views related to the proposal. This preamble responds to all major 
comments.
    The Response to Comments Document placed in the docket (EDOCKET 
ID: OAR-2002-0005 discusses individual comments that EPA 
received and EPA's responses to those comments. Below we discuss 
changes that we made in response to the public comment and the 
rationale for today's final action.

A. Summary of Comments and Final Changes to Sec.  194.6--Process for 
Adding Minor Alternative Provisions

    In the proposed rule, we discussed why EPA considers that the 
existing provisions specific to minor revisions are unnecessarily 
stringent and why the change is necessary (67 FR 51933-34). EPA's 
oversight experience indicates that minor revisions to the Compliance 
Criteria requirements may improve implementation and consistency in 
regulatory compliance. Also, we acknowledged that for all alternative 
provisions that do not meet the proposed definition of ``minor 
alternative provisions,'' the Agency will continue to comply with the 
current requirements of Sec.  194.6.
    EPA proposed ``minor alternative provision'' as an alternative 
provision that ``clarifies a regulatory provision, or does not 
substantively alter the existing regulatory requirement.'' Thus, 
revisions that do not alter the intent or the approach to verifying 
compliance of an existing regulatory requirement are considered to 
constitute minor alternative provisions. As examples, we cited the 
proposed revisions to Sec. Sec.  194.2, 194.12, 194.13, and 
194.24(c)(3) as minor revisions which the commenters supported (see 
Response to Comments Document, EDOCKET ID: OAR-2002-0005). 
Some commenters suggested an alternate definition to better clarify the 
intent. In today's action, we have added additional language to the 
definition to emphasize that a ``minor alternative provision'' would 
only clarify an existing regulatory provision and not substantially 
alter the regulatory requirements. The EPA is finalizing this 
definition for ``minor alternative provision'' which comports fully 
with the radioactive waste disposal regulations at 40 CFR part 191. In 
addition, this definition does not substantively alter the scope of the 
Compliance Criteria. More substantial revisions to 40 CFR part 194 
would continue to follow the process laid out originally in Sec.  194.6 
and now contained at Sec.  194.6(a). We believe this change will make 
EPA's regulatory activities more efficient and improve the 
implementation of minor revisions to the Compliance Criteria.
    We proposed that a 30-day comment period is sufficient for the 
public to provide the Agency with relevant input on such minor 
revisions to the Compliance Criteria. In addition to the publication of 
a proposed rule in the Federal Register for minor provisions, EPA 
committed to announce the proposal on the Agency's Web site and place 
all relevant supporting materials in the Agency's public docket. Public 
comments expressed concern that a 30-day comment period is too short a 
time to comment on EPA's proposals concerning minor revisions to the 
Compliance Criteria. The streamlined process for minor provisions is 
intended to apply to changes that provide clarification and are 
uncontroversial or purely administrative--not highly technical or 
complex actions. Therefore, the Agency believes that in most cases a 
30-day comment period will be sufficient and has retained this minimum 
requirement in the final rule. The Agency retains discretion to extend 
the comment period when deemed necessary.

B. Summary of Comments and Final Changes to Sec.  194.8(b)--Waste 
Generator Site Inspection and Approval Process

1. Background
    As discussed in the proposed rule, the purpose of EPA inspections 
at DOE sites is to verify that TRU waste sites are characterizing and 
tracking waste to ensure the volume and characteristics of the wastes 
conform with the requirements of the WIPP LWA and the specific 
conditions of the Certification Decision. The requirements at Sec.  
194.8(b) establish a process by which EPA determines whether DOE 
complies with Condition 3 of the Certification Decision. This requires 
that the Agency approve the programs for characterizing TRU waste 
streams using the process set

[[Page 42574]]

forth in Sec.  194.8. (See 40 CFR part 194, appendix A.) Section 194.8 
requires that, prior to sending waste from a generator site for 
disposal at WIPP, DOE must implement and obtain EPA approval of the 
``system of controls'' (that is, personnel, equipment, and procedures) 
used at the site to characterize the waste and measure the waste 
contents determined to be significant (i.e., ten significant 
radionuclides, ferrous and non-ferrous metals, cellulosics, plastics 
and paper) (63 FR 27392, May 18, 1998). Before approving DOE sites' 
waste characterization activities, EPA must inspect individual sites to 
verify that the sites have adequately implemented the proposed 
characterization programs.
2. Baseline Inspection Process
    Under the revised inspection and approval process, EPA proposed the 
following changes (67 FR 51934-41; August 9, 2002):
     Conduct a baseline inspection at all TRU waste generator/
storage sites once in accordance with the Sec.  194.8 requirements and 
approve different WC program components based on the site's 
demonstration of its capabilities;
     Issue a Federal Register notice discussing Sec.  194.8 
inspection results and EPA's proposed ``Baseline Compliance Decision.'' 
The notice will specify what subsequent WC program changes or expansion 
must undergo further EPA inspection or approval under Sec.  194.24 by 
assigning ``tiering'' designations to these activities. The notice will 
provide in detail the reasons for supporting the approval of individual 
WC program components, tier assignments and accompanying reporting 
requirements, and any limitations.
     Seek public comment on the proposed Baseline Compliance 
Decision (i.e., comment on which activities should be assigned to each 
tier) and place the supporting documents in the public docket as 
described in Sec.  194.67; and
     Evaluate and approve, if necessary, changes to the 
approved WC program activities at all sites. Inspections necessary for 
evaluation and/or approval of the changes will be conducted under 
authority of Sec.  194.24(h), not under Sec.  194.8. (No change in the 
continued compliance inspections at sites approved per the Baseline 
Compliance Decision.)

Today, we are finalizing the above aspects of our proposed inspection 
and approval process. We believe that these changes will not in any way 
compromise EPA's ability to oversee TRU waste sites' compliance with 
Sec.  194.24 requirements. Also, these changes will clearly delineate 
the reasons for and the timing of the approval of different WC program 
component changes and the waste streams that must be approved by EPA. 
These changes will give TRU waste sites flexibility to seek limited or 
broader approval during the initial inspection by demonstrating that 
their WC programs can appropriately characterize a limited number or 
wide spectrum of TRU wastes. EPA, under its continued compliance 
authority, will verify that all sites characterize TRU wastes using 
only the EPA-approved WC programs.
    We believe these changes will not lessen, but rather strengthen our 
ability to oversee DOE's TRU waste characterization activities and 
monitor sites' compliance with Condition 3 of the WIPP Certification 
Decision. The new process will not alter our authority or a site's 
ability to limit or expand the scope of WC program components. Rather, 
it will enable us to determine independently whether a subsequent 
inspection is necessary, when it should occur or whether a decision to 
allow a site to implement a change without EPA's approval is 
appropriate.
    Many commenters were very concerned that the revised approval 
scheme would reduce the frequency of EPA inspections or even that once 
approved, sites might be able to operate WC programs indefinitely with 
little or no EPA oversight. They also expressed concern that the 
proposed tiering process allows undue discretion by DOE in determining 
what WC program changes at generator sites are significant. The 
comments indicate that EPA did not make sufficiently clear the nature 
and purpose of the proposed changes to the inspections process. In 
response, we find that it is necessary to further clarify and elaborate 
on the revised approval process and its implementation.
    EPA does not believe that the proposed changes would reduce either 
the number of inspections nor the level of oversight and enforcement at 
DOE sites. The changes will modify the EPA inspection and approval 
procedures, but will not necessarily affect the frequency or number of 
times a site will be inspected. Under 40 CFR part 194, EPA may inspect 
DOE TRU sites' waste characterization activities using the inspection 
authority under Sec.  194.8 and Sec.  194.24. The new process provides 
that the individual waste generator sites will need only one Sec.  
194.8 approval from EPA to conduct WC activities. However, this single 
Sec.  194.8 approval will specify any limitations on the approval that 
will necessitate additional inspections by EPA. Any such additional 
inspections will be conducted under authority of Sec.  194.24(h), not 
under Sec.  194.8. Limitations on the initial Sec.  194.8 approval may 
relate to waste streams, waste categories, processes, or other factors 
deemed important by EPA and will specify what WC program expansions or 
changes must undergo further EPA inspection or approval under Sec.  
194.24. Furthermore, EPA's proposed Baseline Compliance Decision, 
including any proposed limitations, will be subject to public comment.
    The Agency does not agree that it is necessary to require a re-
evaluation of EPA's site-specific Baseline Compliance Decisions at a 
set interval. As discussed in the preamble to the proposed rule and 
reiterated above, EPA will conduct additional site inspections under 
Sec.  194.24 to verify continued compliance with the baseline approval 
in accordance with the tiering designations or as otherwise deemed 
necessary. Since 1998, EPA has inspected WC programs at TRU waste sites 
under Sec.  194.24 on an approximately annual basis. We are likely to 
maintain at least the same frequency for future continued compliance 
inspections under Sec.  194.24 and may inspect more frequently as 
certain activities warrant. A reduced frequency of inspections might 
also be warranted if, for example, a site has no characterization 
activity over a period of time. The final rule offers flexibility in 
scheduling inspections as necessary while not diminishing in any way 
the effectiveness of our inspections program.
    Generally, the Agency has conducted continuing compliance 
inspections to coincide with DOE's annual recertification audits. In 
its comments, DOE has requested that EPA continue to conduct the 
baseline inspections at the approved sites when DOE performs these 
audits. However, since the site inspections EPA would conduct to derive 
the Baseline Compliance Decision would be more detailed than DOE's 
annual recertification audits, these inspections will be scheduled by 
EPA and may or may not coincide with the DOE's recertification audits.
    Because EPA expects to continue to inspect sites regularly, we do 
not believe it is necessary to specify an expiration date for the 
baseline compliance approval. Through ongoing compliance inspections 
(prompted by tiered activities/changes at the site or at EPA's own 
discretion under Sec.  194.24), EPA will validate that approved 
processes and equipment continue to be adequately implemented. The 
baseline approval will remain valid so long as

[[Page 42575]]

the site continues to demonstrate appropriate use of approved 
processes.
    Table 1 provides a comparison of the previous site inspection/
approval process and the new Baseline Compliance Decision process. By 
adopting the WC program approval process we are finalizing today, EPA 
will achieve the following goals:
    1. Maintain or improve oversight;
    2. Improve public involvement and allow direct input in approval 
decisions;
    3. Allow greater discretion in establishing technical priorities 
and accommodating varying degrees of WC experience at generator sites; 
and
    4. Reduce regulatory burden by limiting Federal Register 
announcements under Sec.  194.8 that the Agency must issue, and allow 
greater flexibility in scheduling inspections.

                      Table 1.--Current Approval and Baseline Compliance Decision Processes
----------------------------------------------------------------------------------------------------------------
                                         Current inspection/      Baseline compliance
               Activity                    approval process         decision process             Comment
----------------------------------------------------------------------------------------------------------------
Regulatory driver for waste            Sec.   194.8...........  Sec.   194.8...........  Meet Condition 3 of the
 characterization inspection.                                                             WIPP Certification
                                                                                          Decision.
Notifying EPA of its readiness.......  Yes....................  Only new sites seeking   EPA will inform each
                                                                 initial approval.        site with an approved
                                                                                          WC program the timing
                                                                                          for the inspection.
Announce inspection in Federal         Every time a site seeks  --Only for Baseline
 Register notice.                       EPA approval to use a    inspection to approve
                                        new or modified WC       site-specific WC
                                        process or to ship any   program.
                                        new TRU waste stream    --No FR announcements
                                        or a group of waste      for all followup tier-
                                        streams for disposal.    designated approvals.
Report information specific to WC      DOE must provide waste   --For the Baseline
 processes.                             characterization plan    inspection EPA will
                                        and quality assurance    tell sites the type of
                                        program plan for each    information needed.
                                        initial approval.       --For followup
                                                                 inspections sites will
                                                                 provide information
                                                                 specified under each
                                                                 of the WC process
                                                                 tiers.
Assign tiers based on adequacies and   No.....................  Yes....................  Will require a
 limitations of WC processes                                                              thorough, detailed
 demonstrated.                                                                            review to identify
                                                                                          situations that would
                                                                                          require EPA approval.
Require followup/additional            Rarely.................  Possible...............  If the potential
 inspections before approval.                                                             application of
                                                                                          different WC
                                                                                          components covers a
                                                                                          wide spectrum of TRU
                                                                                          waste streams.
Seeking public comment on the          No.....................  Yes....................
 inspection results and pending
 approval.
Issuing a site approval decision.....  30 days after the        After the end of public  Increased public
                                        announcement of the      comment period allowed   involvement;
                                        inspection in the        to respond to the        transparent decision
                                        Federal Register.        pending site approval    process.
                                                                 decision announced in
                                                                 the Federal Register.
Require additional Sec.   194.8        For any new WC           No.....................  The need for additional
 inspections.                           equipment/process or a                            Sec.   194.8
                                        waste stream approval.                            inspections negated by
                                                                                          tiering signifying the
                                                                                          need for approval
                                                                                          under Sec.   194.24.
Inspect sites for continued            Yes....................  Yes....................  To ensure that site is
 compliance under Sec.   194.24 and                                                       using previously
 issuing a letter and an inspection                                                       approved WC program
 report.                                                                                  components to
                                                                                          characterize and
                                                                                          quantify TRU waste
                                                                                          contents.
Inspect sites to evaluate changes to   When the site informs    Identified by EPA as     Eliminates
 the approved WC processes.             EPA of the need.         part of the tiering      interpretation and/or
                                                                 assignments.             guess work by site for
                                                                                          the need for EPA
                                                                                          approval.
----------------------------------------------------------------------------------------------------------------

    When inspecting a waste generator site to render a Baseline 
Compliance Decision, EPA inspectors will evaluate each WC program 
component (equipment, procedure, and personnel training/experience) for 
its adequacy and appropriateness in characterizing TRU waste destined 
for WIPP disposal. The elements of this inspection will be the same as 
those followed in the current site inspection process discussed in the 
proposal (67 FR 51935-36). Depending on the site's demonstration of WC 
capabilities, the baseline inspection could cover a broad spectrum of 
WC processes and waste streams or could be limited to specific 
equipment or one waste stream. During the inspection a site must 
demonstrate its capabilities to characterize TRU waste(s) using 
appropriate equipment, procedures, and personnel and comply with the 
regulatory limits under Sec.  194.24. The site also must demonstrate 
how the WC information is compiled and tracked using the EPA-approved 
WIPP Waste Information System (WWIS).
    Under today's rule, EPA's baseline approval will specify any 
limitations on the approval. It will also specify what subsequent WC 
program changes or expansion must undergo further EPA inspection or 
approval under Sec.  194.24 by assigning ``tiers'' to each of these 
activities. The tiering will be based on the following: Which WC 
processes the site has demonstrated to be suitable to and capable of 
characterizing a given

[[Page 42576]]

TRU waste type and the historical knowledge about the physical and 
radiological waste characteristics. EPA will assign the tiering 
designations. This eliminates the possibility of misinterpretation on 
DOE's part and the possibility of EPA not agreeing with DOE's selection 
of a tier. In addition, the public will have the opportunity to comment 
on which activities should be assigned to each tier.
    EPA would like to further clarify the details of the tiers. Tier 1 
waste characterization activities at a site will have more stringent 
reporting requirements. These activities will require notification by 
DOE and approval by EPA prior to shipment of waste to the WIPP. We 
expect to conduct site inspections as part of our decision-making 
process for many Tier 1 activities. Tier 2 activities will have more 
moderate reporting requirements and EPA may approve changes to certain 
activities without a follow-up inspection (i.e., desktop review and 
approval of certain technical documents). These activities will require 
a notification by DOE to EPA on the specific changes; however, waste 
can be shipped to the WIPP without prior Agency approval. For Tier 2 
notifications, EPA will review the documentation provided by DOE and 
reply only if additional information or analysis is needed. Other 
changes (i.e., if no tier is specified) will be captured in DOE's 
annual change reports or continuing compliance inspections under Sec.  
194.24.
    DOE will report any changes in equipment, processes, or personnel, 
based on their tier level, and certain changes must be reported to EPA 
before the sites are allowed to ship waste using the waste 
characterization activities in question. EPA will then decide whether 
or not a follow-up inspection is necessary to confirm and verify the 
adequacy of any changes to the site's waste characterization program. 
EPA may also conduct unannounced site inspections of a tiered activity 
if EPA determines a need based on the available information. Below are 
examples of how the tiers may be assigned:
     In its baseline inspection by EPA, a site (``Site 1'' in 
this example) demonstrates that it can quantify 10 WIPP-tracked 
radionuclides only in homogeneous organic solids using a particular 
piece of radioassay equipment (``Equipment A'' in this example). The 
baseline approval for Site 1 is issued and the non-destructive assay 
(NDA) equipment is approved with the limitation that it may be used to 
characterize only homogeneous solids. As part of the baseline approval, 
the change to use Equipment A on a new waste stream is designated a 
Tier 1 change. Therefore, if Site 1 would like to use Equipment A to 
characterize inorganic sludge then an additional EPA approval will be 
necessary.
     Site 1 would now like to use a different piece of 
equipment (``Equipment B'' in this example) to characterize the same 
waste stream that they are already approved for (in this case, 
homogeneous solids). Equipment B is nearly identical to Equipment A in 
specifications and operating controls. As part of the baseline 
approval, EPA specifies that using equivalent equipment to characterize 
an approved waste stream is a Tier 2 change. Therefore, Site 1 notifies 
EPA of its plans, provides documentation to EPA that Equipment A and B 
are equivalent, and can install and operate the new equipment without 
prior approval by the Agency.
    For both Tier 1 and 2 changes, DOE must submit to EPA information 
discussing the relevant program changes for our evaluation. Prior to 
approval, Tier 1 changes may require an inspection to obtain objective 
evidence demonstrating a site's WC program adequacy and WC data showing 
compliance with the WIPP compliance criteria at 40 CFR 194. EPA will 
docket and post information from these Sec.  194.24 inspections on the 
WIPP Web site for public review. Generally, Tier 2 changes would not 
require inspections, provided that EPA is satisfied with the 
information submitted by DOE regarding the changes. EPA's approval 
letter discussing Tier 1 or Tier 2 changes would explain how the 
available information was sufficient to justify a decision, or what 
additional information was collected during an inspection, if one was 
conducted. Also, EPA will docket and post on the WIPP Web site the Tier 
2 approval letter and DOE submission for public review.
    Major sites with an approved waste characterization program 
(Hanford, LANL, INEEL, RFETS, and SRS) and those requiring EPA approval 
(such as Oak Ridge National Laboratory) will be subject to a mandatory 
inspection to render the site-specific Baseline Compliance Decision and 
accompanying tiers. A few commenters misconstrued that once the Agency 
renders a Baseline Compliance Decision specific to the DOE's Central 
Characterization Project (CCP), the CCP can apply the approved WC 
activities at any TRU site. Commenters are incorrect with their 
understanding of the limitations of EPA's CCP approval. Currently, EPA 
inspects and approves the CCP program at each site and the approval is 
site-specific whenever a site hires CCP to characterize their TRU 
waste. EPA has followed this approach and has approved the CCP WC 
activities at the SRS, ANL-E, and NTS. Once today's rule becomes 
effective, EPA will inspect the above major sites with approved WC 
programs, sites with the approved CCP WC activities, and the remaining 
TRU waste generator/storage sites and render a Baseline Compliance 
Decision specific to each individual site. Each TRU site with an 
approved WC program may continue to dispose of their approved TRU waste 
streams at the WIPP. All TRU waste sites remain subject to applicable 
Federal and State regulations governing packaging, transportation, and 
disposal regulations for TRU waste.
    Once the Baseline Compliance Decision has been made and tiers have 
been assigned at each site, the EPA may decide to revise the tiering 
designations, based on a variety of factors. Some sites may have a 
harder time converting to the more robust inspections regime, and 
certain aspects of their WC program that were strong in the past may 
need more intense scrutiny. Conversely, certain sites will undoubtedly 
improve their overall performance as they become accustomed to the new 
system, and certain aspects of their WC program will subsequently 
require less attention.
    The decision to revise tiers at a site will be made through 
continued compliance inspections under the authority of Sec.  
194.24(h), as previously discussed. The Agency will announce the 
proposed tier changes and the reasoning behind them in the site's 
inspection report, which will be posted on the WIPP Web site and 
docketed in accordance with Sec.  194.67. If the tier change is an 
elevation in stringency from Tier 2 to Tier 1 (i.e., additional DOE 
reporting requirements for that particular waste characterization 
component or activity), the change will be effective immediately and 
the site will be expected to operate under the more stringent 
requirements without delay. If, however, the change is a ``downgrade'' 
in stringency from Tier 1 to Tier 2, the inspection report will solicit 
comments from the public, for a minimum of 30 days, to let them raise 
any concerns they might have. The site will continue to operate under 
the more stringent tier designation until public comment can be 
considered.
    The site inspections necessary to develop the Baseline Compliance 
Decision have three components which we will include in our inspection 
report: (a) Description of what we inspected and found to be 
technically

[[Page 42577]]

adequate; (b) tiering of WC elements and the basis for the tiering 
assignment; and (c) identification of site's subsequent reporting 
requirements for the specific WC elements. Currently, EPA inspection 
reports describe what we inspect, what we determine to be technically 
adequate, what we identify as deficiencies and whether any corrective 
action is required before EPA approval. Under the new process, we will 
continue to complete a report containing these elements. In addition, 
the inspection will allow us to determine WC component modifications 
requiring EPA approval.
    The results of all EPA site inspections (and their accompanying 
inspection reports), under Sec.  194.8 and Sec.  194.24, will be made 
available to the public in EPA's dockets, WIPP Web site, and other 
means. If, at any time, we determine 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.
3. Opportunity for Public Comment & Length of Public Comment Periods
    As previously discussed, the Agency aims to improve public 
participation by providing an opportunity to comment on EPA inspection 
reports and proposed approval decision in addition to DOE program 
documents and other information. Thus, the public would be well 
informed about the inspection that was performed, which decisions are 
proposed and why, and can provide comments related to the approval and 
tiering process.
    After completing the baseline Sec.  194.8 inspections to determine 
capabilities and adequacy of WC program at each TRU site, EPA will 
prepare an inspection report discussing the inspection process and the 
findings and/or concerns. The site-specific inspection report will 
discuss various WC process-specific tiers and their basis. They will 
also contain subsequent reporting requirements for the WC program 
components. Using this information, we will issue the proposed Baseline 
Compliance Decision in the Federal Register for public comment (see 
discussion for the public comment period below). In addition, we will 
make available in the EPA Docket our inspection report and the site-
specific waste characterization documents for public review. Most 
commenters responding to this issue supported the proposal. One 
commenter contended that this would result in unnecessary operational 
delays and costs. As discussed in the Response to Comments Document 
(See EDOCKET ID: OAR-2002-0005), EPA does not agree with the 
reasoning as the approved TRU sites can continue to dispose of their 
approved waste streams at the WIPP.
    Today, we are finalizing a 45-day comment period when seeking 
public comment related to EPA's site-specific Baseline Compliance 
Decision and associated tier assignments. Several commenters stated 
that a 30-day comment period is not adequate, especially considering 
the amount and nature of the technical material kept in the docket and 
commenters' other work priorities. As discussed in the Response to 
Comments Document (EDOCKET ID: OAR-2002-0005), the public-
notice-and-approval process described in Sec.  194.8(b) has not yielded 
the level of comment that we anticipated.
    Over the past 4 years, EPA has made every effort to inform public 
of EPA inspections when necessary by issuing a Federal Register notice 
and posting updates on the EPA's WIPP Web site. DOE documents and other 
material related to these inspections has also been docketed at each of 
our docket locations. However, we recognize that the highly technical 
nature of the documents available for comment may have discouraged 
public participation. In recognition of this, the changes to the site 
approval process include significant changes to the public comment 
process. The changes allow for comment not only on DOE's technical 
documents, but also on EPA's proposed decision on site approval. The 
public will also be able to comment directly on the proposed tiering 
designations (and associated level of EPA review and approval) for 
subsequent changes or expansions of the WC program at a given site. A 
minimum 45-day comment period will be opened for the proposed Baseline 
Compliance Decisions at each site. As a general rule, EPA will allow 45 
days for receiving public comment and may provide additional time on a 
case-by-case basis when needed. Thus, the public will have an 
opportunity to review and comment on EPA's proposed Baseline Compliance 
Decisions and inspection reports prior to site approvals.
    The Agency also acknowledges that the Federal Register is not the 
only effective tool for providing information to the public. Under 
these revisions, EPA will issue a Federal Register notice for the 
initial Baseline Compliance Decision at each site. EPA also expects to 
use e-mail, web updates, and other more user-friendly communication 
tools to notify stakeholders of the occurrence and results of baseline 
approvals and subsequent ongoing inspections.
    As discussed previously (see Section III.B.2), if EPA deems that a 
change in tiering designation (from Tier 1 to Tier 2) at a site is 
warranted, the Agency will announce the proposed changes and the 
reasoning behind them in the site's inspection report, which will be 
posted on the WIPP Web site and placed in the dockets. EPA will also 
open a minimum 30-day comment period on the proposed change. However, 
where circumstances warrant, EPA will consider a longer comment period.
4. Time Frame and Effective Date
    Although today's actions will be effective on October 14, 2004, EPA 
expects that the baseline compliance inspections and approval process 
will be more wide-ranging than the current inspection regime since it 
will not be limited by waste stream designations and will explicitly 
address future expansions of the characterization program. The first 
approvals conducted under the new process are likely to be highly 
detailed and very intensive, since EPA will need to work with DOE and 
stakeholders to ensure that the full range of waste characterization 
activities is identified and placed in appropriate reporting/approval 
tiers. The final rule provides important flexibility to ensure that EPA 
can effectively implement--and that the public can fully understand and 
participate in--the new process. First, the final rule does not 
establish a time period within which EPA must ``convert'' sites to the 
new inspections and approval process. DOE sites with approved waste 
characterization programs will be allowed to continue operations under 
the existing inspection and approval process based on waste streams; 
the waste stream system, while less flexible than the newly revised 
process, remains rigorous and can continue to provide effective 
oversight during the transition period. We expect to review approved 
programs and issue new baseline approval decisions for those sites 
within approximately two years. However, the Agency retains the 
discretion to take longer (if warranted) by the complexity of technical 
issues or the scope of more comprehensive inspections. Similarly, we 
decline to limit the length of the comment period on proposed baseline 
approval decisions. We believe that limiting the available comment 
period would be counterproductive for both EPA and the public in 
adjusting to the new process, and could constrain discussion if 
unanticipated or especially complex issues arise.

[[Page 42578]]

5. Consideration of Resources
    A few commenters endorsed the proposed changes to Sec.  194.8, but 
did not necessarily agree with EPA's resource rationale. The Agency 
believes that the proposed changes are fully justifiable on a technical 
basis, as outlined above in Section III.B.2. While resource 
consideration is a valid factor, the discussion of resources in the 
preamble to the proposal may have been misleading in regard to its 
relative importance. The revised process provides equivalent or 
improved oversight, more control over schedule, better prioritization 
of technical issues and distinctions, and flexibility to address 
relative levels of experience or expertise at various DOE sites.
6. Compliance of Waste Generator Sites and the WIPP Facility
    Some commenters expressed concern about the reference in the 
proposed Sec.  194.8(b)(3)(i) to Sec.  194.48(b)(1) and (2). They 
suggested that the provisions of Sec.  194.4 are specific to the WIPP 
site itself and are not appropriate responses to noncompliance at a 
waste generator site. The Agency disagrees with those statements. 
Section 194.8(b)(4)(i) provides that EPA may suspend shipments of TRU 
waste from an approved TRU waste site if EPA subsequently determines 
that waste characterization programs or processes are not adequately 
established or implemented. In addition, if necessary, EPA may take 
action under Sec.  194.4(b)(1) or (2). Section 194.4(b)(1) provides 
that EPA may suspend, modify, or revoke the certification of the WIPP. 
Suspension may be at the discretion of EPA; modification or revocation 
will be conducted by rule pursuant to 5 U.S.C. 553. Section 
194.8(b)(3)(i) provides that EPA may request that DOE provide 
information to enable EPA to determine whether suspension, 
modification, or revocation of the certification is warranted. DOE's 
inability to properly establish, maintain, or implement adequate waste 
characterization activities at a waste generator site could lead to 
circumstances that necessitate consideration of suspension, 
modification, or revocation of the WIPP certification. Poorly and/or 
inadequately characterized waste when emplaced in the repository could 
be relevant to determining the long-term performance of the WIPP. 
Therefore, EPA disagrees that the provisions of Sec.  194.4(b) are 
specific only to the WIPP facility, and can never be relevant to 
activities at a waste generator site.

C. Summary of Comments and Final Changes to Sec. Sec.  194.12 and 
194.13--Number and Form of DOE Compliance Applications and Reference 
Materials

    EPA proposed to revise Sec.  194.12 by changing the number of 
copies of compliance applications in printed form from 30 to 5 (one 
original and four printed copies). In addition, the Agency proposed to 
revise Sec.  194.12 by requiring that DOE submit 10 complete compliance 
applications in alternative format (e.g., compact disk) or other 
approved format. (For a detailed discussion, see 67 FR 51941-42.)
    Also, the Agency proposed to revise Sec.  194.13 by changing the 
number of copies in printed form of the reference materials from 10 to 
5 and to require DOE to submit 10 copies of reference materials in 
alternative format (e.g., compact disk) or other approved format.
    Public comments were supportive of these proposed actions and 
therefore, we are finalizing the proposed requirements under Sec.  
194.12 and Sec.  194.13. Commenters requested clarification that EPA's 
WIPP dockets would continue to be provided paper copies of application 
materials for public review. In accordance with Sec.  194.67, the paper 
copies of compliance applications and related materials will be placed 
in the official docket in Washington, DC, and at the four informational 
dockets in New Mexico.

D. Summary of Comments and Final Changes to Sec. Sec.  194.2 and 
194.24(c)(3)--Terminology Related to Waste Characterization

    Section 194.24, waste characterization, generally requires DOE to 
identify, quantify, and track the chemical, physical, and radiological 
components of the waste destined for disposal at WIPP that may 
influence disposal system performance. Section 194.24(c)(3) requires 
DOE to demonstrate that the use of process knowledge to quantify waste 
components conforms with the quality assurance (QA) requirements 
outlined in Sec.  194.22. To demonstrate compliance, DOE must have 
information and documentation to substantiate that process knowledge 
data acquired and used during waste characterization activities are in 
compliance with the QA requirements.
    The Agency proposed to revise Sec.  194.24(c)(3) by replacing the 
term ``process knowledge'' with the term ``acceptable knowledge.'' The 
term ``acceptable knowledge'' has been the term used by EPA and DOE 
since DOE submitted the Compliance Certification Application, during 
both the certification rulemaking and subsequent site inspections. Use 
of the term ``acceptable knowledge'' in Sec.  194.24(c)(3) in lieu of 
``process knowledge'' will not alter our technical approach to 
verifying compliance during an inspection; rather, it will reflect our 
actual practice more accurately. (For a detailed discussion, see 67 FR 
51942-43.)
    For consistency with the change being proposed today for Sec.  
194.24(c)(3), the Agency also proposed to add the following definition 
of ``acceptable knowledge'' to Sec.  194.2: ``Acceptable knowledge 
means any information about the process used to generate waste, 
material inputs to the process, and the time period during which the 
waste was generated, as well as data resulting from the analysis of 
waste conducted prior to or separate from the waste certification 
process authorized by EPA's Certification Decision, to show compliance 
with Condition 3 of the certification decision (40 CFR part 194, 
appendix A).''
    Both of these changes as proposed were supported by commenters and 
therefore, we are finalizing the definition of ``acceptable knowledge'' 
in Sec. Sec.  194.2 and 24(c)(3).

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866, (58 FR 51735; October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to OMB review and the requirements of the 
Executive Order. The Order defines ``significant regulatory action'' as 
one that is likely to result in a rule that may: (1) Have an annual 
effect on the economy of $100 million or more or adversely affect in a 
material way the economy, a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, or tribal governments or communities; (2) create a serious 
inconsistency or otherwise interfere with an action taken or planned by 
another agency; (3) materially alter the budgetary impact of 
entitlements, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raise novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order. It has been determined 
that this rule is not a ``significant regulatory action'' under the 
terms of Executive Order 12866 and is therefore not subject to OMB 
review.

[[Page 42579]]

B. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective 90 days from publication in the 
Federal Register.

C. Regulatory Flexibility Act

    Today's final rule is not subject to the RFA, which generally 
requires an agency to prepare a regulatory flexibility analysis for any 
rule that will have a significant economic impact on a substantial 
number of small entities. The RFA applies only to rules subject to 
notice-and-comment rulemaking requirements under the Administrative 
Procedure Act (APA) or any other statute. This rule is not subject to 
notice and comment requirements under the APA or any other statute. 
This rule pertains to agency management or personnel, which the APA 
expressly exempts from notice-and-comment rulemaking requirements. 5 
U.S.C. 533(a)(2).
    Although this final rule is not subject to the RFA, EPA nonetheless 
has assessed the potential of this rule to adversely impact small 
entities subject to the rule. Small entities include small businesses, 
small not-for-profit enterprises, and small governmental jurisdictions. 
This final rule will not have a significant economic impact on a 
substantial number of small entities because it sets forth requirements 
which apply only to Federal agencies.

D. Paperwork Reduction Act

    This final action does not impose an information collection burden 
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et 
seq. The Compliance Criteria (in 40 CFR part 194) requirements are 
applicable only to DOE and EPA and do not establish any form of 
collection of information from the public. Burden means the total time, 
effort, or financial resources expended by persons to generate, 
maintain, retain, or disclose or provide information to or for a 
Federal agency. This includes the time needed to review instructions; 
develop, acquire, install, and utilize technology and systems for the 
purposes of collecting, validating, and verifying information, 
processing and maintaining information, and disclosing and providing 
information; adjust the existing ways to comply with any previously 
applicable instructions and requirements; train personnel to be able to 
respond to a collection of information; search data sources; complete 
and review the collection of information; and transmit or otherwise 
disclose the information.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9.

E. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    Today's final rule contains no Federal mandates (under the 
regulatory provisions of Title II of the UMRA) for State, local, or 
tribal governments or the private sector. This rule applies only to 
Federal agencies. Thus, today's rule is not subject to the requirements 
of sections 202 and 205 of the UMRA.

F. Executive Order 12898: Environmental Justice Strategy

    Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations,'' the Agency has considered 
environmental justice related issues with regard to the potential 
impacts of this action on the environmental and health conditions in 
low-income, minority, and native American communities. We have complied 
with this mandate. However, the requirements specifically set forth by 
the Congress in the Waste Isolation Pilot Plant Land Withdrawal Act 
(Pub. L. 102-579), which prescribes EPA's role at the WIPP, did not 
provide authority for EPA to examine impacts in the communities in 
which wastes are produced, stored, and transported, and Congress did 
not delegate to EPA the authority to consider the issue of alternative 
locations for the WIPP.
    During the development of the existing provisions in 40 CFR part 
194, the EPA involved minority and low-income populations early in the 
rulemaking process. In 1993, EPA representatives met with New Mexico 
residents and government officials to identify the key issues that 
concern them, the types of information they wanted from EPA, and the 
best ways to communicate with different sectors of the New Mexico 
public. The feedback provided by this group of citizens formed the 
basis for EPA's WIPP communications and consultation plan. To help 
citizens (including a significant Hispanic population in Carlsbad and 
the nearby Mescalero Indian Reservation) stay abreast of EPA's WIPP-
related activities, the Agency developed many informational products 
and services. The EPA translated into Spanish several documents 
regarding WIPP, including educational materials and fact sheets 
describing EPA's WIPP oversight role and the radioactive waste disposal 
standards. The EPA also established a toll-free WIPP Information Line, 
recorded in both English and Spanish,

[[Page 42580]]

providing the latest information on upcoming public meetings, 
publications, and other WIPP-related activities. The EPA also developed 
a mailing list, which includes many low-income, minority, and native 
American groups, to systematically provide interested parties with 
copies of EPA's public information documents and other materials. Even 
after the final rule, in 1998, EPA has continued to implement outreach 
services to all WIPP communities based on the needs determined during 
the certification.
    This final action does not add or delete any certification 
criteria. The rule will revise the public notice process for the 
approval of waste characterization activities at DOE waste generator 
sites, which produce and store wastes destined for disposal at WIPP. 
Affected communities and the public in general would have the 
opportunity to comment on EPA's proposed waste generator site approval 
decision. The existing provision does not offer such opportunity. The 
proposed revision makes the public comment period more meaningful to 
all communities. The Agency also intends to continue its outreach 
activities to make information on waste characterization activities 
more accessible by using the Internet, EPA information line, and fact 
sheets.

G. National Technology Transfer & Advancement Act of 1995

    Section 12 of the National Technology Transfer & Advancement Act of 
1995 is intended to avoid ``re-inventing the wheel.'' It aims to reduce 
costs to the private and public sectors by requiring federal agencies 
to draw upon any existing, suitable technical standards used in 
commerce or industry. To comply with the Act, EPA must consider and use 
``voluntary consensus standards,'' if available and applicable, when 
implementing policies and programs, unless doing so would be 
``inconsistent with applicable law or otherwise impractical.'' We have 
determined that this regulatory action is not subject to the 
requirements of National Technology Transfer & Advancement Act of 1995 
as this rulemaking is not setting any technical standards.

H. Executive Order 13045: Children's Health Protection

    Executive Order 13045: ``Protection of Children from Environmental 
health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies 
to any rule that: (1) is determined to be ``economically significant'' 
as defined under Executive Order 12866, and (2) concerns an 
environmental health or safety risk that EPA has reason to believe may 
have a disproportionate effect on children. If the regulatory action 
meets both criteria, the Agency must evaluate the environmental health 
or safety effects of the planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency.
    EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that are based on health or safety risks, such that 
the analysis required under section 5-501 of the Order has the 
potential to influence the regulation. This rule is not subject to 
Executive Order 13045 because it does not establish an environmental 
standard intended to mitigate health or safety risks.

I. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. This final action revises 
specific portions of the Compliance Criteria in 40 CFR part 194. These 
criteria are applicable only to DOE (operator) and EPA (regulator) of 
the WIPP disposal facility. Thus, Executive Order 13132 does not apply 
to this rule.

J. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' This final rule does not have 
tribal implications, as specified in Executive Order 13175. This 
proposed action revises specific portions of the Compliance Criteria in 
40 CFR part 194. The Compliance Criteria are applicable only to Federal 
agencies. Thus, Executive Order 13175 does not apply to this rule.

K. Executive Order 13211: Energy Effects

    This final rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355; May 22, 2001) because it is not a 
significant regulatory action under Executive Order 12866.

List of Subjects in 40 CFR Part 194

    Environmental protection, Administrative practice and procedure, 
Nuclear materials, Radionuclides, Plutonium, Radiation Protection, 
Uranium, Transuranics, Waste Treatment and Disposal.

    Dated: July 8, 2004.
Michael O. Leavitt,
Administrator.

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For the reasons set out in the preamble, 40 CFR part 194 is amended as 
follows.

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

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1. The authority citation for part 194 continues to read as follows:

    Authority: Pub. L. 102-579, 106 Stat. 4777, as amended by Pub. 
L. 104-201, 110 Stat. 2422; Reorganization Plan No. 3 of 1970, 35 FR 
15623, Oct. 6, 1970, 5 U.S.C. app. 1; Atomic Energy Act of 1954, as 
amended, 42 U.S.C. 2011-2296 and 10101-10270.


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2. Section 194.2, is amended by adding definitions in alphabetical 
order for ``Acceptable knowledge'' and ``Minor alternative provision'' 
to read as follows:


Sec.  194.2  Definitions.

* * * * *
    Acceptable knowledge means any information about the process used 
to generate waste, material inputs to the process, and the time period 
during which the waste was generated, as well as data resulting from 
the analysis of waste, conducted prior to or separate from the waste 
certification process authorized by EPA's Certification Decision, to 
show compliance with Condition 3 of the certification decision ( 
appendix A of this part).
* * * * *
    Minor alternative provision means an alternative provision to the 
Compliance

[[Page 42581]]

Criteria that only clarifies an existing regulatory provision, or does 
not substantively alter the existing regulatory requirements.
* * * * *

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3. Section 194.6 is revised to read as follows:


Sec.  194.6  Alternative provisions.

    The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute 
for any of the provisions of this part alternative provisions, or minor 
alternative provisions, in accordance with the following procedures:
    (a) Alternative provisions may be substituted after:
    (1) Alternative provisions have been proposed for public comment in 
the Federal Register together with information describing how the 
alternative provisions comport with the disposal regulations, the 
reasons why the existing provisions of this part appear inappropriate, 
and the costs, risks and benefits of compliance in accordance with the 
alternative provisions;
    (2) A public comment period of at least 120 days has been completed 
and public hearings have been held in New Mexico;
    (3) The public comments received have been fully considered; and
    (4) A notice of final rulemaking is published in the Federal 
Register.
    (b) Minor alternative provisions may be substituted after:
    (1) The minor alternative provisions have been proposed for public 
comment in the Federal Register together with information describing 
how they comport with the disposal regulations, the reasons why the 
existing provisions of this part appear inappropriate, and the benefit 
of compliance in accordance with the minor alternative provision;
    (2) A public comment period of at least 30 days has been completed 
for the minor alternative provisions and the public comments received 
have been fully considered;
    (3) A notice of final rulemaking is published in the Federal 
Register for the minor alternative provisions.

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4. Section 194.8 is amended:
0
a. By redesignating paragraph (b) as paragraph (c);
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b. By adding a new paragraph (b) and revising newly designated 
paragraph (c) to read as follows:


Sec.  194.8  Approval process for waste shipment from waste generator 
sites for disposal at the WIPP.

* * * * *
    (b) Waste characterization programs at transuranic waste sites. The 
Agency will establish compliance with Condition 3 of the certification 
using the following process:
    (1) DOE will implement waste characterization programs and 
processes in accordance with Sec.  194.24(c)(4) to confirm that the 
total amount of each waste component that will be emplaced in the 
disposal system will not exceed the upper limiting value or fall below 
the lower limiting value described in the introductory text of Sec.  
194.24(c). Waste characterization processes will include the collection 
and use of acceptable knowledge; destructive and/or nondestructive 
techniques for identifying and measuring waste components; and the 
validation, control, and transmittal to the WIPP Waste Information 
System database of waste characterization data, in accordance with 
Sec.  194.24(c)(4).
    (2) The Agency will verify the compliance of waste characterization 
programs and processes identified in paragraph (b)(1) of this section 
at sites without EPA approval prior to October 14, 2004, using the 
following process:
    (i) 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 also will provide the 
relevant waste characterization program plans and documentation. EPA 
may request additional information from DOE.
    (ii) EPA will conduct a baseline compliance inspection at the site 
to verify that adequate waste characterization program plans and 
technical procedures have been established, and that those plans and 
procedures are effectively implemented. The inspection will include a 
demonstration or test by the site of the waste characterization 
processes identified in paragraph (b)(1) of this section. If an 
inspection does not lead to approval, we will send an inspection report 
to DOE identifying deficiencies and place the report in the public 
docket described in Sec.  194.67. More than one inspection may be 
necessary to resolve compliance issues.
    (iii) The Agency will announce in the Federal Register a proposed 
Baseline Compliance Decision to accept the site's compliance with Sec.  
194.24(c)(4). We will place the inspection report(s) and any supporting 
documentation in the public docket described in Sec.  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.
    (iv) Our written decision regarding compliance with the 
requirements for waste characterization programs and processes 
described in paragraph (b)(1) of this section will be conveyed in a 
letter from the Administrator's authorized representative to DOE. EPA 
will not issue a compliance decision until after the end of the public 
comment period described in paragraph (b)(2)(iii) of this section. 
EPA's compliance decision will respond to significant and timely-
received comments. A copy of our compliance decision will be placed in 
the public docket described in Sec.  194.67. DOE will comply with any 
requirements identified in the compliance decision and the accompanying 
inspection report.
    (3) Subsequent to any positive determination of compliance as 
described in paragraph (b)(2)(iv) of this section, the Agency intends 
to conduct inspections, in accordance with Sec.  194.24(h), to confirm 
the continued compliance of approved waste characterization programs 
and processes at transuranic waste sites. EPA will make the results of 
these inspections available to the public in the dockets described in 
Sec.  194.67.
    (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

[[Page 42582]]

waste streams may be disposed at WIPP without written EPA approval.
    (iii) EPA may conduct inspections in accordance with Sec.  
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.
    (5) 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 Sec.  194.67.
    (ii) If the revised designation entails more 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 designated entails less stringent notification 
and approval requirements, (e.g., from 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.
    (6) A waste generator site that EPA approved for characterizing and 
disposing transuranic waste at the WIPP under this section prior to 
October 14, 2004, may continue characterizing and disposing such waste 
at the WIPP under paragraph (c) of this section until EPA has conducted 
a baseline compliance inspection and provided a Baseline Compliance 
Decision under paragraph (b)(2) of this section.
    (i) Until EPA provides a Baseline Compliance Decision for such a 
site, EPA may approve additional transuranic waste streams for disposal 
at WIPP under the provisions of paragraph (c) of this section. Prior to 
the effective date of EPA's Baseline Compliance Decision for such a 
site, EPA will continue to conduct inspections of the site in 
accordance with Sec.  194.24(c).
    (ii) EPA shall conduct a baseline compliance inspection and issue a 
Baseline Compliance Decision for such previously approved sites in 
accordance with the provisions of paragraph (b) of this section, except 
that the site shall not be required to provide written notification of 
readiness as described in paragraph (b)(2)(i) of this section.
    (c) Waste characterization programs at waste generator sites with 
prior approval. For a waste generator site that EPA approved for 
characterizing and disposing transuranic waste at the WIPP under this 
section prior to October 14, 2004, the Agency will determine compliance 
with the requirements for use of process knowledge and a system of 
controls at waste generator sites as set in this paragraph (c). 
Approvals for a site to characterize and dispose of transuranic waste 
at WIPP will proceed according to this section only until EPA has 
conducted a baseline compliance inspection and provided a Baseline 
Compliance Decision for a site under paragraph (b)(2) of this section.
    (1) For each waste stream or group of waste streams at a site, the 
Department must:
    (i) Provide information on how process knowledge will be used for 
waste characterization of the waste stream(s) proposed for disposal at 
the WIPP; and
    (ii) Implement a system of controls at the site, in accordance with 
Sec.  194.24(c)(4), to confirm that the total amount of each waste 
component that will be emplaced in the disposal system will not exceed 
the upper limiting value or fall below the lower limiting value 
described in the introductory text of Sec.  194.24(c). The 
implementation of such a system of controls shall include a 
demonstration that the site has procedures in place for adding data to 
the WIPP Waste Information System (``WWIS''), and that such information 
can be transmitted from that site to the WWIS database; and a 
demonstration that measurement techniques and control methods can be 
implemented in accordance with Sec.  194.24(c)(4) for the waste 
stream(s) proposed for disposal at the WIPP.
    (2) The Agency will conduct an audit or an inspection of a 
Department audit for the purpose of evaluating the use of process 
knowledge and the implementation of a system of controls for each waste 
stream or group of waste streams at a waste generator site. The Agency 
will announce a scheduled inspection or audit by the Agency with a 
notice in the Federal Register. In that or another notice, the Agency 
will also solicit public comment on the relevant waste characterization 
program plans and Department documentation, which will be placed in the 
dockets described in Sec.  194.67. A public comment period of at least 
30 days will be allowed.
    (3) The Agency's written decision regarding compliance with the 
requirements for waste characterization programs described in paragraph 
(b)(1) of this section for one or more waste streams from a waste 
generator site will be conveyed in a letter from the Administrator's 
authorized representative to the Department. No such compliance 
determination shall be granted until after the end of the public 
comment period described in paragraph (b)(2) of this section. A copy of 
the Agency's compliance determination letter will be placed in the 
public dockets in accordance with Sec.  194.67. The results of any 
inspections or audits conducted by the Agency to evaluate the plans 
described in paragraph (b)(1) of this section will also be placed in 
the dockets described in Sec.  194.67.
    (4) Subsequent to any positive determination of compliance as 
described in paragraph (b)(3) of this section, the Agency intends to 
conduct inspections, in accordance with Sec. Sec.  194.21 and 
194.24(h), to confirm the continued compliance of the programs approved 
under paragraphs (b)(2) and (b)(3) of this section. The results of such 
inspections will be made available to the public through the Agency's 
public dockets, as described in Sec.  194.67.

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5. Section 194.12 is revised to read as follows:


Sec.  194.12  Submission of compliance applications.

    Unless otherwise specified by the Administrator or the 
Administrator's authorized representative, 5 copies of any compliance 
application(s), any accompanying materials, and any amendments thereto 
shall be submitted in a printed form to the Administrator's authorized 
representative. These paper copies are intended for the official docket 
in Washington, DC, as well as the four informational dockets in 
Albuquerque and Santa Fe, New Mexico. In addition, DOE shall submit 10 
copies of the complete application in alternative format (e.g., compact 
disk) or other approved format, as specified by the Administrator's 
authorized representative.

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6. Section 194.13 is revised to read as follows:


Sec.  194.13  Submission of reference materials.

    Information may be included by reference into compliance

[[Page 42583]]

applications(s), provided that the references are clear specific and 
that unless, otherwise specified by the Administrator or the 
Administrator's authorized representative, 5 copies of reference 
information are submitted to the Administrator's authorized 
representative. These paper copies are intended for the official docket 
in Washington, DC, as well as the four informational dockets in 
Albuquerque and Santa Fe, New Mexico. Reference materials that are 
widely available in standard text books or reference books need not to 
be submitted. Whenever possible, DOE shall submit 10 copies of 
reference materials in alternative format (e.g., compact disk) or other 
approved format, as specified by the Administrator's authorized 
representative.

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7. Section 194.24 is amended by revising paragraph (c)(3) to read as 
follows:


Sec.  194.24  Waste characterization.

* * * * *
    (c) * * *
    (3) Provide information that demonstrates that the use of 
acceptable knowledge to quantify components in waste for disposal 
conforms with the quality assurance requirements of Sec.  194.22.
* * * * *
[FR Doc. 04-16207 Filed 7-15-04; 8:45 am]
BILLING CODE 6560-50-P