
[Federal Register: November 18, 2010 (Volume 75, Number 222)]
[Rules and Regulations]               
[Page 70584-70595]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no10-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 194

[EPA-HQ-OAR-2009-0330; FRL-9227-4]

 
Criteria for the Certification and Recertification of the Waste 
Isolation Pilot Plant's Compliance With the Disposal Regulations: 
Recertification Decision

AGENCY: Environmental Protection Agency.

ACTION: Recertification decision.

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SUMMARY: With this document, the Environmental Protection Agency (EPA) 
recertifies that the U.S. Department of Energy's (DOE) Waste Isolation 
Pilot Plant (WIPP) continues to comply with the ``Environmental 
Standards for the Management and Disposal of Spent Nuclear Fuel, High-
Level and Transuranic (TRU) Radioactive Waste.'' EPA initially 
certified that WIPP met applicable regulatory requirements on May 18, 
1998, and the first shipment of waste was received at WIPP on March 26, 
1999. The first Compliance Recertification Application (CRA) was 
submitted by DOE to EPA on March 26, 2004, and the Agency's first 
recertification decision was issued on March 29, 2006.

DATES: Effective November 18, 2010.

FOR FURTHER INFORMATION CONTACT: Ray Lee or Jonathan Walsh, Radiation 
Protection Division, Mail Code 6608J, U.S. Environmental Protection 
Agency, 1200 Pennsylvania Avenue, Washington, DC 20460; telephone 
number: 202-343-9463 or 202-343-9238; fax number: 202-343-2305; e-mail 
address: lee.raymond@epa.gov or walsh.jonathan@epa.gov. Copies of the 
Compliance Application Review Documents (CARDs) supporting today's 
action and all other recertification-related documentation can be found 
in the Agency's electronic docket found at http://www.regulations.gov 
(FDMS Docket ID No. EPA-HQ-OAR-2009-0330) or on its WIPP Web site 
(http://www.epa.gov/radiation/wipp).

SUPPLEMENTARY INFORMATION: EPA initially certified that WIPP met 
applicable regulatory requirements on May 18, 1998 (63 FR 27354), and 
the first shipment of waste was received at WIPP on March 26, 1999. The 
first Compliance Recertification Application (CRA) was submitted by DOE 
to EPA on March 26, 2004, and the Agency's first recertification 
decision was issued on March 29, 2006 (71 FR 18010-18021).
    This action represents the Agency's second periodic evaluation of 
WIPP's continued compliance with the disposal regulations and WIPP 
Compliance Criteria. The compliance criteria implement and interpret 
the disposal regulations specifically for WIPP. As directed by Congress 
in the WIPP Land Withdrawal Act (LWA), this ``recertification'' process 
will occur five years after the WIPP's initial receipt of TRU waste 
(March 26, 1999), and every five years thereafter (e.g., March 2004, 
March 2009) until the end of the decommissioning phase. For each 
recertification--including the one being announced with today's 
action--DOE must submit documentation of the site's continuing 
compliance with the disposal regulations to EPA for review. In 
accordance with the WIPP Compliance Criteria, documentation of 
continued compliance was made available in EPA's dockets, and the 
public was provided at least a 30-day period in which to submit 
comments. In addition, all recertification decisions must be announced 
in the Federal Register. According to the WIPP LWA, Section 8(f), these 
periodic recertification determinations are not subject to rulemaking 
or judicial review.
    This action is not a reconsideration of the decision to open WIPP. 
Rather, recertification is a process that evaluates changes at WIPP to 
determine if the facility continues to meet all the requirements of 
EPA's disposal regulations. The recertification process ensures that 
WIPP's continued compliance is demonstrated using the most accurate, 
up-to-date information available.
    This recertification decision is based on a thorough review of 
information submitted by DOE, independent technical analyses, and 
public comments. The Agency has determined that DOE continues to meet 
all applicable requirements of the WIPP Compliance Criteria, and with 
this notice, recertifies the WIPP facility. This recertification 
decision does not otherwise amend or affect EPA's radioactive waste 
disposal regulations or the WIPP Compliance Criteria.

Table of Contents

I. General Information
II. What is WIPP?
    A. 1998 Certification Decision
    B. 2006 Recertification Decision
III. With which regulations must WIPP comply?
    A. Radioactive Waste Disposal Regulations & Compliance Criteria
    B. Compliance With Other Environmental Laws and Regulations
IV. What has EPA's role been at WIPP since the 1998 certification 
decision?
    A. Continuing Compliance
    B. Annual Change Reports

[[Page 70585]]

    C. Monitoring the Conditions of Compliance
    D. Inspections and Technical Exchanges
V. What is EPA's 2010 recertification decision?
    A. What information did the Agency examine to make its final 
decision?
    B. Content of the Compliance Recertification Application 
(Sec. Sec.  194.14 and 194.15)
    C. Performance Assessment: Modeling and Containment Requirements 
(Sec. Sec.  194.14, 194.15, 194.23, 194.31 through 194.34)
    D. General Requirements
    E. Assurance Requirements (Sec. Sec.  194.41 Through 194.46)
    F. Individual and Groundwater Protection Requirements 
(Sec. Sec.  194.51 Through 194.55)
VI. How has the public been involved in EPA's WIPP recertification 
activities?
    A. Public Information
    B. Stakeholder Meetings
    C. Public Comments on Recertification
VII. Where can I get more information about EPA's WIPP-related 
activities?
    A. Supporting Documents for Recertification
    B. WIPP Web Site & WIPP-NEWS E-mail Listserv
    C. Dockets
VIII. What happens next for WIPP? What is EPA's role in future WIPP 
activities?

I. General Information

A. How can I get copies of this document and other related information?

    1. Docket. EPA has established a docket for this action under 
Docket ID No. EPA-HQ-OAR-2009-0330. Publicly available docket materials 
are available either electronically at http://www.regulations.gov or in 
hard copy at the Air and Radiation Docket in the EPA Docket Center, 
(EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, 
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the Air and Radiation Docket is (202) 566-1742. As 
provided in EPA's regulations at 40 CFR part 2, and in accordance with 
normal EPA docket procedures, if copies of any docket materials are 
requested, a reasonable fee may be charged for photocopying.
    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/.

II. What is WIPP?

    The Waste Isolation Pilot Plant (WIPP) is a disposal system for 
defense-related transuranic (TRU) radioactive waste. Developed by the 
Department of Energy (DOE), WIPP is located near Carlsbad in 
southeastern New Mexico. At WIPP, radioactive waste is disposed of 
2,150 feet underground in an ancient salt layer which will eventually 
creep and encapsulate the waste. WIPP has a total capacity of 6.2 
million cubic feet of waste.
    Congress authorized the development and construction of WIPP in 
1980 ``for the express purpose of providing a research and development 
facility to demonstrate the safe disposal of radioactive wastes 
resulting from the defense activities and programs of the United 
States.'' \1\ The waste which may be emplaced in the WIPP is limited to 
TRU radioactive waste generated by defense activities associated with 
nuclear weapons; no high-level waste or spent nuclear fuel from 
commercial power plants may be disposed of at the WIPP. TRU waste is 
defined as materials containing alpha-emitting radioisotopes, with half 
lives greater than twenty years and atomic numbers above 92, in 
concentrations greater than 100 nano-curies per gram of waste.\2\
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    \1\ Department of Energy National Security and Military 
Applications of Nuclear Energy Authorization Act of 1980, Public Law 
96-164, section 213.
    \2\ WIPP Land Withdrawal Act, Public Law 102-579, section 2(18), 
as amended by the 1996 WIPP LWA Amendments, Public Law 104-201.
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    Most TRU waste proposed for disposal at the WIPP consists of items 
that have become contaminated as a result of activities associated with 
the production of nuclear weapons (or with the clean-up of weapons 
production facilities), e.g., rags, equipment, tools, protective gear, 
and organic or inorganic sludges. Some TRU waste is mixed with 
hazardous chemicals. Some of the waste proposed for disposal at the 
WIPP is currently located at Federal facilities across the United 
States, including locations in California, Idaho, Illinois, New Mexico, 
Nevada, Ohio, South Carolina, Tennessee, and Washington.
    The WIPP LWA, passed initially by Congress in 1992 and amended in 
1996, is the statute that provides EPA the authority to oversee and 
regulate the WIPP. (Prior to the passage of the WIPP LWA in 1992, DOE 
was self-regulating with respect to WIPP; that is, DOE was responsible 
for determining whether its own facility complied with applicable 
regulations for radioactive waste disposal.) The WIPP LWA delegated to 
EPA three main tasks, to be completed sequentially, for reaching an 
initial compliance certification decision. First, EPA was required to 
finalize general regulations which apply to all sites--except Yucca 
Mountain--for the disposal of highly radioactive waste.\3\ These 
disposal regulations, located at subparts B and C of 40 CFR part 191, 
were published in the Federal Register in 1985 and 1993.\4\
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    \3\ WIPP LWA, section 8(b).
    \4\ 50 FR 38066-38089 (September 19, 1985) and 58 FR 66398-66416 
(December 20, 1993).
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    Second, EPA was to develop criteria, by rulemaking, to implement 
and interpret the general radioactive waste disposal regulations 
specifically for the WIPP. In 1996, the Agency issued the WIPP 
Compliance Criteria, which are found at 40 CFR part 194.\5\
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    \5\ 61 FR 5224-5245 (February 9, 1996).
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    Third, EPA was to review the information submitted by DOE and 
publish a certification decision.\6\ The Agency issued its 
certification decision on May 18, 1998, as required by Section 8 of the 
WIPP LWA (63 FR 27354-27406).
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    \6\ WIPP LWA, section 8(d).
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A. 1998 Certification Decision

    The WIPP LWA, as amended, required EPA to evaluate whether the WIPP 
site complied with EPA's standards for the disposal of radioactive 
waste. On May 18, 1998 (63 FR 27354-27406), EPA determined that the 
WIPP met the standards for radioactive waste disposal. This decision 
allowed the emplacement of radioactive waste in the WIPP to begin, 
provided that all other applicable health and safety standards, and 
other legal requirements, had been met. The first shipment of TRU waste 
was received at WIPP on March 26, 1999.
    Although EPA determined that DOE met all of the applicable 
requirements of the WIPP Compliance Criteria in its original 
certification decision (63 FR 27354-27406; May 18, 1998), EPA also 
found that it was necessary for DOE to take additional steps to ensure 
that the measures actually implemented at the WIPP (and thus the 
circumstances expected to exist there) were consistent with DOE's 
Compliance Certification Application (CCA) and with the basis for EPA's 
compliance certification. To address these situations, EPA amended the 
WIPP Compliance Criteria, 40 CFR part 194, and appended four explicit 
conditions to its certification of compliance for the WIPP.
    Condition 1 of the certification applies to the panel closure 
system, which is intended, over the long-term, to block brine flow 
between waste panels in WIPP. In the CCA, DOE presented four options 
for the design of the panel closure system, but did not specify which 
one would be constructed at the WIPP facility. The Agency based

[[Page 70586]]

its certification decision on DOE's use of the most robust design 
(referred to in the CCA as ``Option D''). Condition 1 of EPA's 
certification required DOE to implement the Option D panel closure 
system at WIPP, with Salado mass concrete replacing fresh water 
concrete.
    Conditions 2 and 3 of the final certification decision apply to 
activities conducted at waste generator sites that produce TRU waste 
proposed for disposal at WIPP. The WIPP Compliance Criteria (Sec. Sec.  
194.22 and 194.24) require DOE to have, in place, a system of controls 
to measure and track important waste components, and to apply quality 
assurance (QA) programs to waste characterization activities. These two 
Conditions state that EPA must separately approve the QA programs for 
other generator sites (Condition 2) and the waste characterization 
system of controls for other waste streams (Condition 3). The approval 
process includes an opportunity for public comment, and an inspection 
or audit of the waste generator site by EPA. The Agency's approvals of 
waste characterization systems of controls and QA programs are conveyed 
by letter from EPA to DOE. EPA also made changes to the compliance 
criteria in July 2004 (69 FR 42571-42583). These new provisions provide 
equivalent or improved oversight and better prioritization of technical 
issues in EPA inspections to evaluate waste characterization activities 
at DOE WIPP waste generator sites. The new provisions also offer more 
direct public input into EPA's decisions about what waste can be 
disposed of at WIPP. The Agency continues to conduct independent 
inspections to evaluate a site's waste characterization capabilities, 
consistent with Conditions 2 and 3.
    Condition 4 of the certification applies to passive institutional 
controls (PICs). The WIPP Compliance Criteria require DOE to use both 
records and physical markers to warn future societies about the 
location and contents of the disposal system, and thus to deter 
inadvertent intrusion into the WIPP (Sec.  194.43). In the CCA, EPA 
allowed DOE to delay submission of a final PICs design. Condition 4 of 
the certification requires DOE, prior to the submission of the final 
recertification application, to submit a revised schedule showing that 
markers and other measures will be implemented as soon as possible 
after closure of the WIPP. The Department also must provide additional 
documentation showing that it is feasible to construct markers and 
place records in archives as described in the CCA. After WIPP's 
closure, DOE will not be precluded from implementing additional PICs 
beyond those described in the application. DOE recently requested a 
delay for all PICs activities until approximately ten years prior to 
the decommissioning of the WIPP facility (which is currently 
anticipated in 2033). EPA approved the delay (March 7, 2008; Air Docket 
A-98-49, Item II-B2-67), with the condition that it was based on 
current projections and activities and also revised the schedule that 
was proposed originally in November 2002 (Air Docket A-98-49, Item II-
B3-41). This schedule not only gave DOE more time to seek out the most 
viable PICs options, but also ensured that testing and research is in 
fact being done and reported to EPA on a regular basis.
    The complete record and basis for EPA's 1998 certification decision 
can be found in Air Docket A-93-02.

B. 2006 Recertification Decision

    After the 1998 certification decision, EPA continued to conduct 
ongoing independent technical review and inspections of all WIPP 
activities related to compliance with the EPA's disposal regulations. 
The initial certification decision identified the starting (baseline) 
conditions for WIPP and established the waste and facility 
characteristics necessary to ensure proper disposal in accordance with 
the regulations. At that time, EPA and DOE understood that future 
information and knowledge gained from the actual operation of WIPP 
would result in changes to the best practices and procedures for the 
facility. In recognition of this, section 8(f) of the amended WIPP LWA 
requires EPA to evaluate all changes in conditions or activities at 
WIPP every five years to determine if WIPP continues to comply with 
EPA's disposal regulations for the facility.
    The first recertification process, which occurred in 2004-2006, 
included a review of all of the changes made at the WIPP facility since 
the original 1998 EPA certification decision to the submittal of the 
initial CRA. The Agency received DOE's first CRA on March 26, 2004. On 
May 24, 2004, EPA announced the availability of the CRA-2004 and EPA's 
intent to evaluate compliance with the disposal regulations and 
compliance criteria in the Federal Register (69 FR 29646-29649). At 
that time, EPA also began accepting public comments on the application. 
Following over a year of requests for additional information from DOE, 
EPA issued its completeness determination for the CRA-2004 on September 
29, 2005 (70 FR 61107-61111). ``Completeness determinations'' are 
solely administrative steps and do not reflect any conclusion regarding 
WIPP's continued compliance with the disposal regulations.
    All completeness determinations are made using a number of the 
Agency's WIPP-specific guidances; most notably, the ``Compliance 
Application Guidance'' (CAG; EPA Pub. 402-R-95-014) and ``Guidance to 
the U.S. Department of Energy on Preparation for Recertification of the 
Waste Isolation Pilot Plant with 40 CFR parts 191 and 194'' (Docket A-
98-49, Item II-B3-14; December 12, 2000). Both guidance documents 
include guidelines regarding: (1) Content of certification/
recertification applications; (2) documentation and format 
requirements; (3) time frame and evaluation process; and (4) change 
reporting and modification. The Agency developed these guidance 
documents to assist DOE with the preparation of any compliance 
application for the WIPP. They are also intended to assist in EPA's 
review of any application for completeness and to enhance the 
readability and accessibility of the application for EPA and public 
scrutiny.
    Following the September 2005 completeness determination, EPA began 
its in-depth technical review on the CRA-2004 using the entire record 
available to the Agency, which is located in EPA's official Dockets 
(FMDS Docket ID No. EPA-HQ-OAR-2004-0025 found at 
http:www.regulations.gov, and also Air Docket A-98-49). Much of the 
CRA-2004 documentation was also placed on the Agency's WIPP Web site 
(http://www.epa.gov/radiation/wipp/2004application.html and http://
www.epa.gov/radiation/wipp/2006recertfication.html).
    EPA's technical review evaluated compliance of the CRA-2004 with 
each section of the WIPP Compliance Criteria. The Agency focused its 
review on areas of change relative to the original certification 
decision as identified by DOE, in order to ensure that the effects of 
the changes have been addressed. EPA also made sure to address any 
substantial public comments received on the application (e.g., karst, 
waste inventory) in its Compliance Application Review Documents (CARDs) 
and Technical Support Documents (TSDs). On March 29, 2006, EPA 
officially recertified the WIPP facility for the first time, exactly 
six months following the September 2005 completeness determination.

[[Page 70587]]

III. With which regulations must WIPP comply?

A. Radioactive Waste Disposal Regulations & Compliance Criteria

    WIPP must comply with EPA's radioactive waste disposal regulations, 
located at subparts B and C of 40 CFR part 191. These regulations limit 
the amount of radioactive material which may escape from a disposal 
facility, and protect individuals and ground water resources from 
dangerous levels of radioactive contamination. In addition, the 
Compliance Recertification Application (CRA) and other information 
submitted by DOE must meet the requirements of the WIPP Compliance 
Criteria at 40 CFR part 194. The WIPP Compliance Criteria implement and 
interpret the general disposal regulations specifically for WIPP, and 
clarify the basis on which EPA's certification decision is made.

B. Compliance With Other Environmental Laws and Regulations

    The WIPP must also comply with a number of other environmental and 
safety regulations in addition to EPA's disposal regulations \7\--
including, for example, the Solid Waste Disposal Act and EPA's 
environmental standards for the management and storage of radioactive 
waste. Various regulatory agencies are responsible for overseeing the 
enforcement of these Federal laws. For example, enforcement of some 
parts of the hazardous waste management regulations has been delegated 
to the State of New Mexico. The State is authorized by EPA to carry out 
the State's Resource Conservation and Recovery Act (RCRA) programs in 
lieu of the equivalent Federal programs. New Mexico's Environment 
Department (NMED) reviews DOE's permit applications for treatment, 
storage, and disposal facilities for hazardous waste, under Subtitle C 
of RCRA. The State's authority for such actions as issuing a hazardous 
waste operating permit for the WIPP is in no way affected by EPA's 
recertification decision. It is the responsibility of the Secretary of 
Energy to report the WIPP's compliance with all applicable Federal laws 
pertaining to public health and the environment to EPA and the State of 
New Mexico.\8\ Compliance with environmental or public health 
regulations other than EPA's disposal regulations and WIPP Compliance 
Criteria is not addressed by today's action.
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    \7\ Compliance with these regulations is addressed in the site's 
Biennial Environmental Compliance Report (BECR).
    \8\ WIPP LWA, sections 7(b)(3) and 9.
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IV. What has EPA's role been at WIPP since the 1998 certification 
decision and 2006 recertification decision?

A. Continuing Compliance

    Since EPA's 1998 certification decision (and through the initial 
2006 recertification decision), the Agency has been monitoring and 
evaluating changes to the activities and conditions at WIPP. EPA 
monitors and ensures continuing compliance with EPA regulations through 
a variety of activities, including: Review and evaluation of DOE's 
annual change reports, monitoring of the conditions of compliance, 
inspections of the WIPP site, and inspections of waste characterization 
operations.
    At any time, DOE must report any planned or unplanned changes in 
activities pertaining to the disposal system that differ significantly 
from the most recent compliance application (Sec.  194.4(b)(3)). The 
Department must also report any releases of radioactive material from 
the disposal system (Sec.  194.4(b)(3)(iii), (v)). Finally, EPA may 
request additional information from DOE at any time (Sec.  
194.4(b)(2)). This information allows EPA to monitor the performance of 
the disposal system and evaluate whether the certification must be 
modified, suspended, or revoked to prevent or quickly reverse any 
potential danger to public health and the environment.

B. Annual Change Reports

    Under Sec.  194.4(b) DOE was required to submit a report of any 
changes to the conditions and activities at WIPP within six months of 
the 1998 certification decision and annually thereafter. DOE met this 
requirement by submitting the first change report in November 1998 and 
annually thereafter.
    Since 1998, DOE's annual change reports have reflected the progress 
of quality assurance and waste characterization inspections, minor 
changes to DOE documents, information on monitoring activities, and any 
additional EPA approvals for changes in activities and conditions. All 
correspondence and approvals regarding the annual change reports can be 
found in Air Docket A-98-49, Categories II-B2 and II-B3.

C. Monitoring the Conditions of Compliance

    As discussed previously, Condition 1 of the WIPP certification 
requires DOE to implement the Option D panel closure system at WIPP, 
with Salado mass concrete used in place of fresh water concrete. Since 
the 1998 certification decision, DOE has indicated that it would like 
to change the design of the Option D panel closure system selected by 
EPA (Air Docket A-98-49, Item II-B3-19). EPA chose to defer review of a 
new panel closure design until after issuing the first recertification 
decision (Air Docket A-98-49, Item II-B3-42). In November 2002, DOE 
requested permission to install only the explosion isolation portion of 
the Option D panel closure design until EPA and NMED can render their 
respective final decisions on DOE's request to approve a new design for 
the WIPP panel closure system. In December 2002, EPA approved DOE's 
request to install only the explosion wall and to extend the panel 
closure schedule until a new design is approved (Air Docket A-98-49, 
Item II-B3-44). In a January 11, 2007 letter (DOE 2007b), DOE requested 
panel closures be delayed until a new design could be approved. EPA 
approved this request in a February 22, 2007 letter (EPA 2007a), and 
expects DOE to re-submit a new panel closure design after the CRA-2009 
recertification decision. Since 1998, the Agency has conducted numerous 
audits and inspections at waste generator sites in order to implement 
Conditions 2 and 3 of the compliance certification. Notices announcing 
EPA inspections or audits to evaluate implementation of QA and waste 
characterization (WC) requirements at waste generator facilities were 
published in the Federal Register and also periodically announced on 
the Agency's WIPP Web site (http://www.epa.gov/radiation/wipp) and 
WIPP-NEWS e-mail listserv. The public has had the opportunity to submit 
written comments on waste characterization activities and QA program 
plans submitted by DOE in the past, and based on the revised WIPP 
Compliance Criteria, are now able to submit comments on EPA's proposed 
waste characterization approvals (See 69 FR 42571-42583). As noted 
above, EPA's decisions on whether to approve waste generator QA program 
plans and waste characterization systems of controls--and thus, to 
allow shipment of specific waste streams for disposal at WIPP--are 
conveyed by a letter from EPA to DOE. The procedures for EPA's approval 
are incorporated in the amended WIPP Compliance Criteria in Sec.  
194.8.
    Since 1998, EPA has audited and approved the QA programs at 
Carlsbad Field Office (CBFO), Washington TRU Solutions (WTS), Sandia 
National Laboratory (SNL), and at 11 other DOE organizations. Following 
the initial approval of a QA program, EPA conducts follow-up audits to 
ensure

[[Page 70588]]

continued compliance with EPA's QA requirements. EPA's main focus for 
QA programs has been the demonstration of operational independence, 
qualification, and authority of the QA program at each location.
    EPA has approved waste characterization (WC) activities at multiple 
waste generator sites since 1998, including Idaho National Laboratory, 
Hanford, Rocky Flats Environmental Technology Site, Savannah River 
Site, Nevada Test Site, Argonne National Laboratory-East, and General 
Electric Vallecitos Nuclear Center. In the interim since the 2004 CRA, 
remote-handled waste streams were approved for shipment and emplaced at 
WIPP for the first time. EPA inspects waste generator sites to ensure 
that waste is being characterized and tracked according to EPA 
requirements. EPA's WC inspections focus on the personnel, procedures 
and equipment involved in WC. A record of EPA's WC and QA 
correspondences and approvals can be found in Air Docket A-98-49, 
Categories II-A1 and II-A4.
    EPA will evaluate DOE's compliance with Condition 4 of the 
certification when DOE submits a revised schedule and additional 
documentation regarding the implementation of PICs. This documentation 
must be provided to EPA no later than the final recertification 
application. Once received, the information will be placed in EPA's 
public dockets, and the Agency will evaluate the adequacy of the 
documentation. During the operational period when waste is being 
emplaced in WIPP (and before the site has been sealed and 
decommissioned), EPA will verify that specific actions identified by 
DOE in the CCA, CRA, and supplementary information (and in any 
additional documentation submitted in accordance with Condition 4) are 
being taken to test and implement passive institutional controls.

D. Inspections

    The WIPP Compliance Criteria provide EPA the authority to conduct 
inspections of activities at the WIPP and at all off-site facilities 
which provide information included in certification applications (Sec.  
194.21). Since 1998, the Agency has conducted periodic inspections to 
verify the adequacy of information relevant to certification 
applications. EPA has conducted annual inspections at the WIPP site to 
review and ensure that the monitoring program meets the requirements of 
Sec.  194.42. EPA has also inspected the emplacement and tracking of 
waste in the repository. The Agency's inspection reports can be found 
in Air Docket A-98-49, Categories II-A1 and II-A4.

V. What is EPA's 2010 recertification decision?

    EPA recertifies that DOE's WIPP continues to comply with the 
requirements of subparts B and C of 40 CFR part 191. The following 
information describes EPA's determination of compliance with each of 
the WIPP Compliance Criteria specified by 40 CFR part 194.
    The recertification process will not be used to approve any new 
significant changes proposed by DOE; any such proposals will be 
addressed separately by EPA. Recertification will ensure that WIPP is 
operated using the most accurate and up-to-date information available 
and provides documentation requiring DOE to operate to these standards.

A. What information did the Agency examine to make its final decision?

    40 CFR part 194 sets out those elements which the Agency requires 
to be in any complete compliance application. In general, compliance 
applications must include information relevant to demonstrating 
compliance with each of the individual sections of 40 CFR part 194 to 
determine if the WIPP will comply with the Agency's radioactive waste 
disposal regulations at 40 CFR part 191, subparts B and C. The Agency 
published the ``Compliance Application Guidance for the Waste Isolation 
Pilot Plant: A Companion Guide to 40 CFR Part 194'' (CAG) which 
provided detailed guidance on the submission of a complete compliance 
application (EPA Pub. No. 402-R-95-014, Air Docket A-93-02, Item II-B2-
29).\10\
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    \10\ Section 194.11 provides that EPA's certification evaluation 
would not begin until EPA notified DOE of its receipt of a 
``complete'' compliance application. This ensures that the full six-
month period for EPA's review, as provided by the WIPP LWA, shall be 
devoted to substantive, meaningful review of the application (61 FR 
5226).
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    To make its decision, EPA evaluated basic information about the 
WIPP site and disposal system design, as well as information which 
addressed all the provisions of the compliance criteria. As required by 
Sec.  194.15(a), DOE's CRA-2009 updated the previous compliance 
application (CRA-2004) with sufficient information for the Agency to 
determine whether or not WIPP continues to be in compliance with the 
disposal regulations.
    As mentioned previously, the first step in recertification is 
termed the ``completeness determination.'' ``Completeness'' is a key 
administrative step that EPA uses to determine that any recertification 
application addresses all the required regulatory elements and provides 
sufficient information for EPA to conduct a full, technical review. 
Following receipt of DOE's second CRA on March 24, 2009, EPA began to 
identify areas of the application where additional information was 
needed. A June 16, 2009 Federal Register notice announced availability 
of the CRA-2009 and opened the official public comment period. Over the 
course of the following 12 months, the Agency submitted five official 
letters (May 21, 2009; July 16, 2009; October 19, 2009; January 25, 
2010; and February 22, 2010) to DOE requesting additional information 
regarding the CRA. The Department responded with a series of ten 
letters (August 24, 2009; September 30, 2009; November 25, 2009; 
January 12, 2010; February 22, 2010; March 31, 2010; April 12, 2010; 
April 19, 2010; May 26, 2010; and June 24, 2010) submitting all of the 
requested supplemental information to EPA. On June 29, 2010, EPA 
announced that DOE's recertification application was complete (75 FR 
41421-41424).
    EPA also relied on materials prepared by the Agency or submitted by 
DOE in response to EPA requests for specific additional information 
necessary to address technical sufficiency concerns. For example, EPA 
directed DOE to conduct a revised performance assessment--referred to 
as the performance assessment baseline calculation (PABC)--to address 
technical issues. Though recertification is not an official rulemaking, 
the Agency also considered public comments related to recertification, 
concerning both completeness and technical issues.
    In summary, EPA's recertification decision is based on the entire 
record available to the Agency, which is located in its official 
dockets (FMDS Docket ID No. EPA-HQ-OAR-2009-0330, and Air Docket A-98-
49). The record consists of the complete CRA, supplementary information 
submitted by DOE in response to EPA requests for additional 
information, technical reports generated by EPA, EPA audit and 
inspection reports, and public comments submitted on EPA's proposed 
recertification decision during the public comment period. All 
pertinent CRA-2009 correspondence was placed in our dockets (FDMS 
Docket No. OAR-2009-0330) and on our WIPP Web site (http://www.epa.gov/
radiation/wipp/2009application.html).
    EPA's technical review evaluated compliance of the CRA with each 
section of the WIPP Compliance Criteria. The Agency focused its review

[[Page 70589]]

on areas of change relative to the initial recertification decision as 
identified by DOE, in order to ensure that the effects of the changes 
have been addressed. As with its original recertification decision, 
EPA's evaluation of DOE's demonstration of continuing compliance with 
the disposal regulations is based on the principle of reasonable 
expectation. 40 CFR 191.13(b) states, ``proof of the future performance 
of a disposal system is not to be had in the ordinary sense of the word 
in situations that deal with much shorter time frames. Instead, what is 
required is a reasonable expectation, on the basis of the record before 
the implementing agency, that compliance with Sec.  191.13(a) will be 
achieved.'' As discussed in 40 CFR part 191, and applied to the 1998 
certification decision and 2006 recertification decision, reasonable 
expectation is used because of the long time period involved and the 
nature of the events and processes at radioactive waste disposal 
facilities. There are inevitable and substantial uncertainties in 
projecting disposal system performance over long time periods. EPA 
applies reasonable expectation to the evaluation of both quantitative 
(i.e., performance assessment) and qualitative (i.e., assurance 
requirements) aspects of any compliance application.
    The Agency produced a suite of documents during its technical 
review. EPA's Compliance Application Review Documents (CARDs) 
correspond in number to the sections of 40 CFR part 194 that they 
respectively address. Each CARD enumerates all changes made by DOE 
impacting a particular section of the rule, and EPA's process and 
conclusions. CARDs are found at Docket A-98-49, Category V-B. Technical 
Support Documents (TSDs) were prepared to address specific topics in 
greater detail, and are found in Docket A-98-49, Category II-B1. 
Together, the CARDs and TSDs thoroughly document EPA's review of DOE's 
compliance recertification application and the technical rationale for 
the Agency's decisions.

B. Content of the Compliance Recertification Application (Sec. Sec.  
194.14 and 194.15)

    According to Sec.  194.14, any compliance application must include, 
at a minimum, basic information about the WIPP site and disposal system 
design. This section focuses on the geology, hydrology, hydrogeology, 
and geochemistry of the WIPP disposal system. A compliance application 
must also include information on WIPP materials of construction, 
standards applied to design and construction, background radiation in 
air, soil, and water, as well as past and current climatological and 
meteorological conditions. Section 194.15 states that recertification 
applications shall update this information to provide sufficient 
information for EPA to determine whether or not WIPP continues to be in 
compliance with the disposal regulations.
    In Section 15 of the 2009 CRA, DOE identified changes to the 
disposal system between the 2004 CRA and 2009 CRA, including changes 
that were approved by EPA and changes to technical information relevant 
to Sec. Sec.  194.14 and 194.15. Noteworthy changes discussed in the 
2009 CRA include enhanced monitoring leading to an updated 
understanding of Culebra transmissivity and new transmissivity field 
calculations. Although EPA considers these updates important to the 
current understanding of the disposal system, EPA determined that the 
changes, both individually and collectively, do not have a significant 
impact on the performance of the disposal system. Today's notice 
summarizes the most important of these changes.
    Culebra Dolomite: The Culebra Dolomite is considered the primary 
pathway for long-term radionuclide transport in ground water. As part 
of the required monitoring program, DOE monitors water levels in the 
Culebra. At the time of the 2004 CRA, observed fluctuations and a 
general increase in the water levels of Culebra monitoring wells was 
poorly understood and attributed to human influences, such as potash 
mining and petroleum production. These water levels establish the 
hydraulic gradient across the site, which in turn influences 
radionuclide travel times for the purposes of performance assessment. 
DOE uses the Culebra hydrologic data in combination with geologic 
information and modeling software to develop transmissivity fields for 
performance assessment (PA) modeling. The approach DOE used in the 2004 
CRA was considered adequate by EPA, but lacked strong prediction power 
for transmissivity at specific points. [See EPA 2004 Performance 
Assessment Baseline Calculation (PABC) Technical Support Document (TSD) 
(Air Docket A-98-49, Item II-B1-16).]
    Since the 2004 CRA, DOE conducted a Culebra well optimization 
program to determine where new water monitoring wells were needed most 
and which old wells could be plugged and abandoned. Additionally, DOE 
added well instrumentation that produces virtually continuous data, 
offering a more complete record of the changes in water pressure than 
manual monthly measurements previously provided. The new monitoring 
data allowed DOE to develop transmissivity fields that are geologically 
based, consistent with observed groundwater heads, consistent with 
groundwater responses in Culebra pump tests, and consistent with water 
chemistry. Furthermore, Culebra water-level changes previously 
considered unpredictable and anthropogenic in origin can now be 
demonstrated to be responses to rainfall in Nash Draw, while others can 
be conclusively linked to well drilling activities. This understanding 
facilitated the development of the revised Culebra Hydrology Conceptual 
Model, which was peer reviewed in 2008. A detailed discussion of these 
changes is found in 2009 CRA CARD 15. In conclusion, EPA finds that DOE 
has adequately characterized and assessed the site characteristics for 
the purposes of the PA and has demonstrated continued compliance with 
Sec. Sec.  194.14 and 194.15.
    In addition to technical changes identified by DOE and EPA, the 
Agency received comments regarding the geology surrounding the WIPP 
site. As during the 2004 CRA, some stakeholders commented that karst 
features are prevalent in the vicinity of WIPP. Karst is a type of 
topography in which there are numerous sinkholes and large voids, such 
as caves. Karst is caused when rainwater reacts with carbon dioxide 
from the air, forms carbonic acid, and seeps through the soil into the 
subsurface to dissolve soluble rocks such as limestone and evaporites. 
If substantial karst features were present at WIPP, they could increase 
the speed at which releases of radionuclides travel away from the 
repository through the subsurface to the accessible environment.
    In the 1998 certification decision, EPA reviewed existing 
information and concluded that, although it is possible that 
dissolution has occurred in the vicinity of the WIPP site sometime in 
the past (e.g., Nash Draw was formed ~500,000 years ago), dissolution 
is not an ongoing, pervasive process at the WIPP site. Therefore, karst 
feature development would not impact the containment capabilities of 
the WIPP for at least the 10,000-year regulatory period (Air Docket A-
93-02, Item III-B-2, CCA CARD 14).
    Following the 1998 certification decision, several groups 
challenged EPA's decision in the United States Court of Appeals for the 
District of Columbia Circuit (No. 98-1322), including EPA's conclusions 
regarding

[[Page 70590]]

karst at the WIPP site. On June 28, 1999, the U.S. Court of Appeals 
upheld all aspects of EPA's 1998 certification decision, including 
EPA's conclusion that karst is not a feature that will impact the 
containment capabilities of the WIPP.
    During the 2004 CRA, some stakeholders continued to assert that the 
geologic characterization of the subsurface surrounding the WIPP 
repository does not adequately identify the presence of karst. As a 
result of these concerns, EPA conducted a thorough review of the 
geologic and hydrologic information related to karst. EPA made a site 
visit to re-examine the evidence of karst around the WIPP site, 
prepared a technical support document (TSD) that discusses EPA's in-
depth review of the karst issue for recertification (Air Docket A-98-
49, Item II-B1-15), and requested that DOE/SNL conduct a separate 
analysis of the potential for karst and address issues raised by 
stakeholders. These efforts reaffirmed the previous conclusion that 
pervasive karst processes have been active outside the WIPP site, but 
not at WIPP.
    Again during the 2009 CRA, some stakeholders argued that major 
karst features are present at WIPP, based on a report by Dr. Richard 
Phillips (2009 \9\) which purported to correlate fluctuations of the 
water levels of monitoring wells with rainfall events in order to prove 
that rainwater reached the Culebra Dolomite through karst. EPA analyzed 
the Phillips report and directed SNL to respond to challenges to the 
conceptual model. The Phillips report failed to support hydrologic 
arguments for the presence of karst, or to acknowledge analyses by SNL 
which integrate pressure changes due to rainfall into a robust, peer-
reviewed conceptual model. The Agency finds that the data continue to 
support the conclusion made during the CCA that karst will not impact 
the WIPP site over the regulatory timeframe. The 2008 peer review of 
the revised Culebra Hydrology Conceptual Model came to a similar 
conclusion. Additional information on this topic is found in EPA's 2009 
CRA Compliance Application Review Document (CARD) 15.
---------------------------------------------------------------------------

    \9\ ``PROOF OF RAPID RAINWATER RECHARGE AT THE WIPP SITE''; 
Richard Hayes Phillips, PhD; March 25, 2009.
---------------------------------------------------------------------------

C. Performance Assessment: Modeling and Containment Requirements 
(Sec. Sec.  194.14, 194.15, 194.23, 194.31 Through 194.34)

    The disposal regulations at 40 CFR part 191 include requirements 
for containment of radionuclides. The containment requirements at 40 
CFR 191.13 specify that releases of radionuclides to the accessible 
environment must be unlikely to exceed specific limits for 10,000 years 
after disposal. At WIPP, the specific release limits are based on the 
amount of waste in the repository at the time of closure (Sec.  
194.31). Assessment of the likelihood that WIPP will meet these release 
limits is conducted through the use of a process known as performance 
assessment, or PA.
    The WIPP PA process culminates in a series of computer simulations 
that attempts to describe the physical attributes of the disposal 
system (site characteristics, waste forms and quantities, engineered 
features) in a manner that captures the behaviors and interactions 
among its various components. The computer simulations require the use 
of conceptual models that represent physical attributes of the 
repository based on features, events, and processes that may impact the 
disposal system. The conceptual models are then expressed as 
mathematical relationships, which are solved with iterative numerical 
models, which are then translated into computer codes. (Sec.  194.23) 
The results of the simulations are intended to show estimated releases 
of radioactive materials from the disposal system to the accessible 
environment over the 10,000-year regulatory time frame.
    The PA process must consider both natural and man-made processes 
and events which have an effect on the disposal system (Sec. Sec.  
194.32 and 194.33). The PA must consider all reasonably probable 
release mechanisms from the disposal system and must be structured and 
conducted in a way that demonstrates an adequate understanding of the 
physical conditions in the disposal system. The PA must evaluate 
potential releases from both human-initiated activities (e.g., via 
drilling intrusions) and natural processes (e.g., dissolution) that may 
occur independently of human activities. DOE must justify the omission 
of events and processes that could occur but are not included in the 
final PA calculations.
    The results of the PA are used to demonstrate compliance with the 
containment requirements in 40 CFR 191.13. The containment requirements 
are expressed in terms of ``normalized releases.'' The results of the 
PA are assembled into complementary cumulative distribution functions 
(CCDFs) which indicate the probability of exceeding various levels of 
normalized releases. (Sec.  194.34)
    To demonstrate continued compliance with the disposal regulations, 
DOE submitted a new PA as part of the 2009 CRA. EPA monitored and 
reviewed changes to the PA since the PABC-04, summarized below.
    DOE performed two conceptual model peer reviews between the 
submission of the 2004 CRA and the 2009 CRA: The WIPP Revised Disturbed 
Rock Zone and Cuttings and Cavings Submodels Peer Review, and the 
Culebra Hydrogeology Conceptual Model Peer Review. These revisions did 
not result in significant changes to the 2009 CRA PA. DOE again updated 
its analysis of features, events and processes (FEPs) that could impact 
WIPP. As in the 2004 CRA, this update of FEPs did not result in any 
changes to the scenarios used in the CRA PA. Since the 2004 PABC, DOE 
updated a number of parameters, including duration of a direct brine 
release, cellulosics, plastics, and rubber (CPR) degradation rates, 
BRAGFLO (computer code) flow chemistry implementation, capillary 
pressure and related permeability, and the drilling rate and borehole 
plugging patterns. DOE also corrected minor parameter errors. For more 
information, refer to 2009 CRA CARDs 23 and 24.
    EPA examined the recent inventory updates and changes, mainly the 
Annual Transuranic Waste Inventory Report (ATWIR) 2007 and the ATWIR 
2008, and determined that a new performance assessment needed to be 
conducted in order to include updated inventory information, such as an 
increase in chemical components (see 2009 CRA CARD 24, Table 24-2, 
produced from PAIR 2008 Table 5-7). In its first completeness letter 
(dated May 21, 2009, items 1-G-3 and 1-23-1 [EPA 2009a]), EPA directed 
DOE to perform updated PA calculations using the updated inventory. In 
response to EPA's direction, DOE produced the 2009 Performance 
Assessment Baseline Calculations (PABC-09). The Agency's review of the 
PABC-09 found that DOE made all the changes required by EPA, and that 
the PABC demonstrates compliance with the containment requirements 
specified in 40 CFR part 191. The results of the PABC-09 are discussed 
below. Additional detail on the Agency's review of the PABC-09 may be 
found in CARDs 23, 24, 31-34, and specifically in the PABC-09 TSD 
(Docket A-98-49, Category II-B1).
    The 2009 CRA PA and PABC-09 included calculations of the same 
scenarios as the original CCA PA: (1) The undisturbed scenario, where 
the repository is not impacted by human activities, and three drilling 
scenarios, (2) the E1 Scenario, where one or more boreholes penetrate a 
Castile brine

[[Page 70591]]

reservoir and also intersect a repository waste panel, (3) the E2 
Scenario, where one or more boreholes intersect a repository waste 
panel but not a brine reservoir, and (4) the E1E2 Scenario, where there 
are multiple penetrations of waste panels by boreholes of the E1 or E2 
type, at many possible combinations of intrusions times, locations, and 
E1 or E2 drilling events.
    The 2009 Culebra modeling predicted shorter travel time for a 
particle to travel through the Culebra to the WIPP site boundary than 
did the 2004 PABC. Three main changes contributed to these changes in 
flow time: The Bureau of Land Management (BLM) redefined the definition 
of minable potash in 2009, in particular within the WIPP site near the 
waste disposal panels; matrix distribution coefficients 
(Kds) decreased several orders of magnitude for most 
radionuclides when the increase in the organic ligand inventory was 
included; and well SNL-14 confirmed the existence of the high-
transmissivity zone in the southeastern portion of the WIPP site. This 
zone allows water to flow faster toward the Land Withdrawal Boundary 
than in PABC-04 calculations. The travel time is closer to that 
predicted in the original compliance certification, and releases remain 
within the limits established by 40 CFR part 191. EPA considers the 
PABC to be a conservative and current representation of the knowledge 
of the WIPP and how it will interact with the surrounding environment. 
EPA finds that DOE is in continued compliance with the requirements of 
40 CFR 194.23 and 194.31 through 194.34. DOE calculated the release 
limits properly (Sec.  194.31), adequately defined the scope of the PA 
(Sec.  194.32), included drilling scenarios as in the original CCA 
(Sec.  194.33), and calculated and presented the results of the 2009 
CRA PA and PABC-09 properly (Sec.  194.34). Details on the PABC-09 may 
be found in EPA's PABC-09 TSD (Docket A-98-49, Category II-B1).
    EPA received public comments related to the 2009 CRA performance 
assessment. Commenters questioned whether the PA encompassed the 
results of specific experiments related to plutonium nanocolloids that 
enhanced groundwater transport capabilities. The Agency asked DOE to 
respond, and in a letter dated September 1, 2010, DOE indicated that 
although the formation of these colloids has been demonstrated to be 
unlikely in the chemical conditions expected at WIPP, the PA 
conservatively takes into consideration the formation and transport of 
intrinsic colloids. For more information, refer to 2009 CRA CARD 24.

D. General Requirements

1. Approval Process for Waste Shipment From Waste Generator Sites for 
Disposal at WIPP (Sec.  194.8)
    EPA codified the requirements of Sec.  194.8 at the time of the 
1998 certification decision. Under these requirements, EPA evaluates 
site specific waste characterization and QA plans to determine that DOE 
can adequately characterize and track waste for disposal at WIPP. Since 
1998, EPA has conducted numerous inspections and approvals pursuant to 
Sec.  194.8.
    EPA previously issued an approval of DOE's general framework for 
characterizing remote-handled (RH) waste in March 2004. This approval 
required DOE to provide site-specific RH waste characterization plans 
and characterization procedures for EPA approval prior to implementing 
them for characterizing and disposing of RH waste at WIPP. Specific RH 
waste streams were approved and emplaced at WIPP for the first time 
during this recertification period.
    For more information on activities related to Sec.  194.8, please 
refer to 2009 CRA CARD 8.
2. Inspections (Sec.  194.21)
    Section 194.21 provides EPA with the right to inspect all 
activities at WIPP and all activities located off-site which provide 
information in any compliance application. EPA did not exercise its 
authority under this section prior to the 1998 certification decision.
    Since 1998, EPA has inspected WIPP site activities, waste generator 
sites, monitoring programs, and other activities. For all inspections, 
DOE provided EPA with access to facilities and records, and supported 
our inspection activities. Information on EPA's 194.21 inspection 
activities can be found in 2009 CRA CARD 21.
3. Quality Assurance (Sec.  194.22)
    Section 194.22 establishes quality assurance (QA) requirements for 
WIPP. QA is a process for enhancing the reliability of technical data 
and analyses underlying compliance applications. Section 194.22 
requires DOE to demonstrate that a Nuclear Quality Assurance (NQA) 
program has been established and executed/implemented for items and 
activities that are important to the long-term isolation of transuranic 
waste.
    EPA determined that the 2009 CRA provides adequate information to 
demonstrate the establishment of each of the applicable elements of the 
NQA standards. EPA has also verified the continued proper 
implementation of the NQA Program through periodic audits conducted in 
accordance with Sec.  194.22(e).
    EPA's determination of compliance with Sec.  194.22 can be found in 
2009 CRA CARD 22.
4. Waste Characterization (Sec.  194.24)
    Section 194.24, waste characterization, generally requires DOE to 
identify, quantify, and track the chemical, radiological and physical 
components of the waste destined for disposal at WIPP. Since the 2004 
CRA, DOE has collected data from generator sites and compiled the waste 
inventory on an annual basis. DOE's 2008 Annual Tranuranic Waste 
Inventory Report (ATWIR 2008) reflected the disposal intentions of the 
waste generator sites as of December 31, 2007. DOE classified the 
wastes as emplaced, stored or projected (to-be-generated). DOE used 
data from the WIPP Waste Information System (WWIS) to identify the 
characteristics of the waste that has been emplaced at WIPP. The 
projected wastes were categorized similarly to existing waste (e.g., 
heterogeneous debris, filter material, soil).
    DOE's 2009 CRA recertification inventory was initially the same 
inventory used for the PABC-04. During its evaluation of the 
completeness of the CRA, however, EPA identified changes in the waste 
inventory that were potentially impactful to PA. As previously 
mentioned, EPA directed DOE to perform the 2009 PABC using the updated 
inventory in the Annual Transuranic Waste Inventory Report-2008. DOE 
generally kept the same categories of waste for the 2009 PABC. The 
major changes were changes to waste volumes and radioactive content 
since the 2004 CRA. Of particular concern to the Agency was an increase 
in the volume of organic ligands in the ATWIR-2008 inventory, which 
bind radionuclides, enhancing their solubility and transport. The 
radioactivity of the waste was estimated to decrease since the 2004 
CRA, principally because of the removal of Hanford tank waste from the 
performance assessment inventory (EPA 2010f). Subsequent to the 
submission of the 2009 CRA, DOE altered the preferred alternatives in 
its Hanford tank waste environmental impact statement, indicating that 
these tank wastes would be managed as High-Level Waste (HLW) [74 FR 
67189 (2009-12-18)]. This change decreased the volume of both contact-
handled and remote-handled waste in the inventory.
    EPA reviewed the CRA and supplemental information provided by DOE 
to determine whether they

[[Page 70592]]

provided a sufficiently complete description of the chemical, 
radiological and physical composition of the emplaced, stored and 
projected wastes proposed for disposal in WIPP. The Agency also 
reviewed DOE's description of the approximate quantities of waste 
components (for both existing and projected wastes). EPA considered 
whether DOE's waste descriptions were of sufficient detail to enable 
EPA to conclude that DOE did not overlook any component that is present 
in TRU waste and has significant potential to influence releases of 
radionuclides. The 2009 CRA did not identify any significant changes to 
DOE's waste characterization program in terms of measurement 
techniques, or quantification and tracking of waste components.
    Since the 1998 certification decision, EPA has conducted numerous 
inspections and approvals of generator site waste characterization 
programs to ensure compliance with Sec. Sec.  194.22, 194.24, and 
194.8. For a summary of EPA's waste characterization approvals, please 
refer to 2009 CRA CARD 8.
    As in previous certifications, stakeholders again commented that 
high-level waste, commercial waste, and spent nuclear fuel must not be 
allowed at WIPP. Commenters also objected to the inclusion in the 
potential inventory of wastes which currently lack a TRU or defense 
determination. EPA reiterates that it will not allow wastes prohibited 
by the Land Withdrawal Act to be shipped to WIPP. All wastes must meet 
the WIPP waste acceptance criteria and all requirements of EPA's waste 
characterization program, and EPA must officially notify DOE before the 
Department is allowed to ship waste to WIPP. Inclusion in the 
performance assessment does not imply EPA's approval of such waste for 
disposal at WIPP.
    Commenters also objected to wastes being shipped to WIPP that have 
not been explicitly included in a compliant performance assessment. 
Inventory, for the purposes of PA, represents a set of bounding 
conditions. Any waste which represents a deviation from the expected 
waste parameters will not be approved until it can be demonstrated not 
to negatively impact PA results (e.g. supercompacted waste).
    Finally, commenters objected to the fact that the Comprehensive 
Inventory Database (CID) is not a public document, and that the legal 
process through which defense and TRU determinations are made is not 
adequately transparent. The Department provided stakeholders with 
additional inventory information. The Agency will continue to work with 
DOE to meet stakeholders' requests for information, and to engage the 
public early in inventory decisions.
    For more information on EPA's determination of compliance with 
Sec.  194.24, please refer to CRA CARD 24.
5. Future State Assumptions (Sec.  194.25)
    Section 194.25 stipulates that performance assessments and 
compliance assessments ``shall assume that characteristics of the 
future remain what they are at the time the compliance application is 
prepared, provided that such characteristics are not related to 
hydrogeologic, geologic or climatic conditions.'' Section 194.25 also 
requires DOE to provide documentation of the effects of potential 
changes of hydrogeologic, geological, and climatic conditions on the 
disposal system over the regulatory time frame. Section 194.25 focuses 
the PA and compliance assessments on the more predictable significant 
features of disposal system performance, instead of allowing unbounded 
speculation on all developments over the 10,000-year regulatory time 
frame.
    EPA concludes that DOE adequately addressed the impacts of 
potential hydrogeologic, geologic and climate changes to the disposal 
system. The 2009 CRA includes all relevant elements of the performance 
assessment and compliance assessments and is consistent with the 
requirements of Sec.  194.25. For more information regarding EPA's 
evaluation of compliance with this section, see 2009 CRA CARDs 25 and 
32, and the corresponding TSD for FEPs (Docket A-98-49, Category II-
B1).
6. Expert Judgment (Sec.  194.26)
    The requirements of Sec.  194.26 apply to expert judgment 
elicitation, which is a process for obtaining data directly from 
experts in response to a technical problem. Expert judgment may be used 
to support a compliance application, provided that it does not 
substitute for information that could reasonably be obtained through 
data collection or experimentation. EPA prohibits expert judgment from 
being used in place of experimental data, unless DOE can justify why 
the necessary experiments cannot be conducted. As in 2004, the 2009 CRA 
did not identify any expert judgment activities that were conducted 
since the 1998 certification decision. Therefore, EPA determines that 
DOE remains in compliance with the requirements of Sec.  194.26. (For 
more information regarding EPA's evaluation of compliance with Sec.  
194.26, see CRA CARD 26.)
7. Peer Review (Sec.  194.27)
    Section 194.27 of the WIPP Compliance Criteria requires DOE to 
conduct peer review evaluations related to conceptual models, waste 
characterization analyses, and a comparative study of engineered 
barriers. A peer review involves an independent group of experts who 
are convened to determine whether technical work was performed 
appropriately and in keeping with the intended purpose. The required 
peer reviews for WIPP must be performed in accordance with the Nuclear 
Regulatory Commission's NUREG-1297, ``Peer Review for High-Level 
Nuclear Waste Repositories,'' which establishes guidelines for the 
conduct of a peer review exercise. DOE performed two conceptual model 
peer reviews between the submission of the 2004 CRA and the 2009 CRA: 
The WIPP Revised Disturbed Rock Zone and Cuttings and Cavings Submodels 
Peer Review, and the Culebra Hydrogeology Conceptual Model Peer Review. 
Additional peer reviews of waste characterization analyses included the 
Los Alamos National Laboratory (LANL) Sealed Sources Peer Review, and 
the LANL Remote-Handled TRU Waste Visual Examination Data Verification 
Peer Review. EPA's review, both at the time of the peer reviews and 
during recertification, verified that the process DOE used to perform 
these peer reviews was compatible with NUREG-1297 requirements. 
Therefore, EPA determines that DOE remains in compliance with the 
requirements of Sec.  194.27. For more information regarding EPA's 
evaluation of compliance with Sec.  194.27, see 2009 CRA CARD 27.

E. Assurance Requirements (Sec. Sec.  194.41-194.46)

    The assurance requirements were included in the disposal 
regulations to compensate in a qualitative manner for the inherent 
uncertainties in projecting the behavior of natural and engineered 
components of the repository for many thousands of years (50 FR 38072). 
The assurance requirements included in the WIPP Compliance Criteria are 
active institutional controls (Sec.  194.41), monitoring (Sec.  
194.42), passive institutional controls (Sec.  194.43), engineered 
barriers (Sec.  194.44), presence of resources (Sec.  194.45), and 
removal of waste (Sec.  194.46).
    As in the 2004 CRA, the 2009 CRA did not reflect any significant 
changes to demonstrating compliance with the assurance requirements. 
DOE appropriately updated the information

[[Page 70593]]

for the assurance requirements in Sections 41 through 46 of the 2009 
CRA, and accurately reflected EPA decisions made since the 2006 
certification decision, such as reducing the safety factor for the 
magnesium oxide engineered barrier from 1.67 to 1.2 (Sec.  194.44). 
EPA's specific evaluation of compliance with the assurance requirements 
can be found in CRA CARDs 41-46.

F. Individual and Groundwater Protection Requirements (Sec. Sec.  
194.51 Through 194.55)

    Sections 194.51 through 194.55 of the compliance criteria implement 
the individual protection requirements of 40 CFR 191.15 and the 
groundwater protection requirements of subpart C of 40 CFR part 191 at 
WIPP. Assessment of the likelihood that the WIPP will meet the 
individual dose limits and radionuclide concentration limits for 
groundwater is conducted through a process known as compliance 
assessment. Compliance assessment uses methods similar to those of the 
PA (for the containment requirements) but is required to address only 
undisturbed performance of the disposal system. That is, compliance 
assessment does not include human intrusion scenarios (i.e., drilling 
or mining for resources). Compliance assessment can be considered a 
``subset'' of performance assessment, since it considers only natural 
(undisturbed) conditions and past or near-future human activities (such 
as existing boreholes), but does not include the long-term future human 
activities that are addressed in the PA.
    Sections 194.51 through 194.55 describe specific requirements for 
compliance with 40 CFR part 191 requirements at WIPP. Section 194.51 
states that the protected individual must be positioned at the location 
where they are expected to receive the highest dose from any 
radioactive release. All potential exposure pathways are to be 
considered and compliance assessments (CAs) must assume that 
individuals consume two liters of water per day according to 40 CFR 
194.52. 40 CFR 194.53 requires that all underground sources of drinking 
water be considered and that connections to surface water be factored 
into any CA. In 40 CFR 194.54 potential processes and events are to be 
considered and selected in any CA and that existing boreholes or other 
drilling activities be considered. 40 CFR 194.55 also requires that the 
impact of uncertainty on any CA analysis and that committed effective 
dose to individuals be calculated. Radionuclide concentrations in 
underground sources of drinking water (USDWs) and dose equivalent 
received from USDWs must also be calculated.
    In the 2009 CRA, DOE reevaluated each of the individual and 
groundwater requirements. DOE again updated parameters related to the 
individual and groundwater requirements for the undisturbed scenario: 
For example, water use changed from 282 gallons per person per day in 
the CCA to 305 in the 2004 CRA, and 273 in the 2009 CRA. By updating 
this information for the compliance assessment and reviewing data from 
water wells that have been drilled since the 2004 CRA, DOE confirmed 
its original water source assumptions (2009 CRA Appendix IDP). DOE did 
not conduct new detailed bounding dose calculations for the 2009 CRA 
because the releases predicted by the 2009 CRA performance assessment 
for the undisturbed scenario were an order of magnitude lower than 
those used in the original CCA (Appendix IGP). EPA reviewed DOE's 2009 
CRA approach to compliance with 40 CFR 194.51 to 40 CFR 194.55. EPA 
verified that DOE's approach to addressing the individual and 
groundwater requirements was the same as the original CCA (CRA CARDs 
51/52, 53, 54, 55 for details), that the 2009 CRA PA results are lower 
than the original CCA and that the recalculation of doses was not 
necessary (2009 CRA Appendix IGP). Because DOE was required to correct, 
update, and rerun the 2009 CRA PA, called the PABC-09, EPA reevaluated 
the impact of these new results on compliance with 40 CFR 194.51 to 40 
CFR 194.55, and found DOE showed continued compliance with this 
requirement, documented in the 2009 PABC summary report (Clayton et al. 
2009, page 21).\10\ Thus, the CCA bounding calculations do not need to 
be redone. EPA finds DOE in continued compliance with 40 CFR 194.51-
194.55 requirements.
---------------------------------------------------------------------------

    \10\ ``Summary Report of the CRA-2009 Performance Assessment 
Baseline Calculation''; Sandia National Laboratories; February 11, 
2010.
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VI. How has the public been involved in EPA's WIPP recertification 
activities?

A. Public Information

    Since the 1998 certification decision, EPA has kept the public 
informed of our continuing compliance activities at WIPP and our 
preparations for recertification. EPA's main focus has been on 
distributing information via the EPA Web site, and e-mail messages via 
its WIPP-NEWS listserv.
    Throughout the recertification process, the Agency posted any 
pertinent new information and/or updates on its WIPP Web site (http://
www.epa.gov/radiation/wipp). Many of our recertification documents 
(including DOE-submitted recertification materials, correspondence, 
Federal Register notices, outreach materials, hearings transcripts, as 
well as technical support documents) are available for review or 
download (in Adobe .pdf format), in addition to a link to our 2009 
recertification docket on the regulations.gov Web site (http://
www.regulations.gov).
    Since February 2009, EPA has sent out numerous announcements 
regarding the recertification schedule, availability of any WIPP-
related documents on the EPA WIPP Web site and its dockets, as well as 
details for the Agency's June 2009 and May 2010 stakeholder meetings in 
New Mexico.

B. Stakeholder Meetings

    As discussed in the WIPP LWA, the recertification process is not a 
rulemaking; therefore public hearings were not required. However, EPA 
held a series of public meetings in New Mexico in June 2009 and May 
2010 to provide information about the recertification process. In an 
effort to make these meetings as informative as possible to all 
attending parties, EPA listened to stakeholder input and concerns and 
tailored the meetings around the public as much as possible.
    The first meetings were held on June 30, 2009, in Albuquerque, New 
Mexico, with both an afternoon and evening session. The main purpose of 
these meetings was to discuss EPA's recertification process and 
timeline, as well as DOE's application and important changes at WIPP 
since the initial recertification process began in 2004. The meetings 
featured brief presentations on the aforementioned topics, as well as a 
roundtable, facilitated discussion. In response to stakeholder 
suggestions, DOE staff members were also on hand to provide information 
and answer any stakeholder questions. Participants were encouraged to 
provide comments to EPA for our consideration during review of DOE's 
WIPP application.
    The second public sessions were held on May 10, 2010, in 
Albuquerque, New Mexico, again with an afternoon and evening session. 
The main purpose of this meeting was to update the public on EPA's 
recertification/completeness schedule and provide more in-depth, 
technical information related to stakeholder questions and comments 
raised at the first series of meetings.
    All of the issues raised at these meetings have been addressed by 
EPA in the Compliance Application Review

[[Page 70594]]

Documents (CARDs) under the relevant section.

C. Public Comments on Recertification

    EPA posted the recertification application on its Web site 
immediately following receipt. EPA formally announced receipt of the 
recertification application in the Federal Register on June 16, 2009. 
The notice also officially opened the public comment period on the 
recertification application.
    For recertification, EPA sought public comments and input related 
to the changes in DOE's application that may have a potential impact on 
WIPP's ability to remain in compliance with EPA's disposal regulations.
    The comment period on the recertification application closed 396 
days after it opened, on August 16, 2010. This closing date was 30 days 
after EPA's announcement in the Federal Register that the 
recertification application was complete.
    EPA received 13 sets of written public comments during the public 
comment period. EPA considered significant comments from the written 
submissions and the stakeholder meetings in its evaluation of 
continuing compliance. EPA addresses these comments in CARDs that are 
relevant to each topic. Additionally, a listing of all comments 
received and responses to each is included in Appendix 15-C of CARD 15.
    In addition to comments on specific sections of 40 CFR part 194, 
EPA received comments on general issues. Some people commented on 
transportation concerns related to WIPP shipments (which are governed 
by U.S. Department of Transportation regulations, not EPA) being 
brought into the State of New Mexico, as well as the ``expansion'' of 
WIPP and associated nuclear energy activities.
    As previously mentioned, EPA provided guidance to DOE on numerous 
occasions regarding its expectations for the first recertification 
application. In response to public comments received during the first 
recertification, EPA and DOE also discussed ways in which both parties 
could improve the overall recertification process.
    One such example is the structure of the CRA-2009. Rather than 
being organized in a chapter format that was established with the 
initial CCA and the CRA-2004, DOE structured the CRA-2009 to mimic the 
structure of 40 CFR part 194, which is organized into topical sections 
of the rule. This format follows the format used by the Agency's CARDs 
and helped to facilitate EPA and stakeholder reviews of the application 
by allowing a more direct evaluation of any changed information with 
respect to previous applications.
    After receipt of the CRA-2009 by EPA and subsequent submissions of 
additional information sent by DOE, the Agency promptly issued its 
completeness determination. Once the recertification application was 
deemed complete, EPA conducted its technical evaluation and is issuing 
the recertification decision within the six-month timeframe specified 
by the WIPP LWA.
    EPA believes that with continued experience, future 
recertifications should become less lengthy. The Agency intends to 
continue to work with DOE and interested stakeholders to discuss and 
work on improving future recertification applications and processes.

VII. Where can I get more information about EPA's WIPP-related 
activities?

A. Supporting Documents for Recertification

    The Compliance Application Review Documents, or CARDs, contain the 
detailed technical rationale for EPA's recertification decision. The 
CARDs discuss DOE's compliance with each of the individual requirements 
of the WIPP Compliance Criteria. The document discusses background 
information related to each section of the compliance criteria, 
restates the specific requirement, reviews the 1998 certification 
decision and 2006 recertification decision, summarizes changes in the 
2009 CRA, and describes EPA's compliance review and decision--most 
notably, any changes that have occurred since the 2006 recertification 
decision. The CARDs also list additional EPA technical support 
documents and any other references used by EPA in rendering its 
decision on compliance. All technical support documents and references 
are available in the Agency's dockets, via http://www.regulations.gov 
(FDMS Docket ID No. EPA-HQ-OAR-2009-0330) or Air Docket A-98-49, with 
the exception of generally available references and those documents 
already maintained by DOE or its contractors in locations accessible to 
the public. For more detailed information on EPA's recertification 
decision, there are a number of technical support documents available, 
which can also be found in the aforementioned docket locations and our 
WIPP Web site.

B. WIPP Web Site & WIPP-NEWS E-Mail Listserv

    For more general information and updates on EPA's WIPP activities, 
please visit our WIPP Internet homepage at http://www.epa.gov/
radiation/wipp. A number of documents (including DOE-submitted 
recertification materials, letters, Federal Register notices, outreach 
materials, hearings transcripts, as well as technical support 
documents) are available for review or download in Adobe .pdf format. 
The Agency's WIPP-NEWS e-mail listserv, which automatically sends 
messages to subscribers with up-to-date WIPP announcements and 
information, is also available online. Any individuals wishing to 
subscribe to the listserv can join by visiting https://lists.epa.gov/
read/all_forums/subscribe?name=wipp-news or by following the 
instructions listed on our WIPP Web site.

C. Dockets

    In accordance with 40 CFR 194.67, EPA maintains public dockets via 
http://www.regulations.gov (FDMS Docket ID No. EPA-HQ-OAR-2009-0330) 
and hard copies in Air Docket A-98-49 that contain all the information 
used to support the Agency's decision on recertification. The Agency 
established and maintains the formal rulemaking docket in Washington, 
DC, as well as informational dockets in three locations in the State of 
New Mexico (Carlsbad, Albuquerque, and Santa Fe). The docket consists 
of all relevant, significant information received to date from outside 
parties and all significant information considered by EPA in reaching a 
recertification decision regarding whether the WIPP facility continues 
to comply with the disposal regulations.
    As part of the eRulemaking Initiative under the President's 
Management Agenda, the Federal Docket Management System (FDMS) was 
established in November 2005. FDMS was created to better serve the 
public by providing a single point of access to all Federal rulemaking 
activities.
    The final recertification decision and supporting documentation can 
be found on EPA's WIPP Web site (http://www.epa.gov/radiation/wipp) or 
the regulations.gov Web site (http://www.regulations.gov) by searching 
for Docket ID No. EPA-HQ-OAR-2009-0330. For more information related to 
EPA's public dockets (including locations and hours of operation), 
please refer to Section 1.A.1 of this document.

VIII. What happens next for WIPP? What is EPA's role in future WIPP 
activities?

    EPA's regulatory role at WIPP does not end with this 
recertification decision. The Agency's future WIPP activities will 
include additional

[[Page 70595]]

recertifications every five years (the next being scheduled to begin in 
March 2014), review of DOE reports on conditions and activities at 
WIPP, assessment of waste characterization and QA programs at waste 
generator sites, announced and unannounced inspections of WIPP and 
other facilities, and, if necessary, modification, revocation, or 
suspension of the certification.
    Although not required by the Administrative Procedures Act (APA), 
the WIPP LWA, or the WIPP Compliance Criteria, EPA intends to continue 
docketing all inspection or audit reports and annual reports and other 
significant documents on conditions and activities at WIPP.
    EPA plans to conduct future recertification processes using a 
similar process to that completed by EPA for this recertification, as 
described in today's action. For example, EPA will publish a Federal 
Register notice announcing its receipt of the next compliance 
application and our intent to conduct such an evaluation. The 
application for recertification will be placed in the docket, and at 
least a 30-day period will be provided for submission of public 
comments. Following the completeness determination, EPA's decision on 
whether to recertify the WIPP facility will again be announced in a 
Federal Register notice (Sec.  194.64).

    Dated: November 9, 2010.
Michael P. Flynn,
Director, Office of Radiation and Indoor Air.
[FR Doc. 2010-28806 Filed 11-17-10; 8:45 am]
BILLING CODE 6560-50-P

