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entitled 'Nuclear Waste: Preliminary Observations on the Quality 
Assurance Program at the Yucca Mountain Repository' which was released 
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Testimony:

Before the Subcommittee on Energy and Water Development, Committee on 
Appropriations, U.S. Senate:

United States General Accounting Office:

GAO:

For Release on Delivery Expected at 4:00 p.m. EDT:

Wednesday, May 28, 2003:

Nuclear Waste:

Preliminary Observations on the Quality Assurance Program at the Yucca 
Mountain Repository:

Statement of Robin M. Nazzaro, Director 
Natural Resources and Environment:

GAO-03-826T:

GAO Highlights:

Highlights of GAO-03-826T, a testimony before the Subcommittee on 
Energy and Water Development, Committee on Appropriations, U.S. 
Senate 

Why GAO Did This Study:

A quality assurance program is required by the Nuclear Regulatory 
Commission (NRC) to ensure that the Department of Energy (DOE) can 
safely construct and operate a high-level radioactive waste 
repository.  DOE is currently preparing an application to NRC for 
authorization to construct the repository.  The quality assurance 
program includes procedures to assure NRC that the information DOE 
provides is verifiable and well documented.  DOE will use a the 
results of a computer simulation to demonstrate that the repository 
can be safely operated over the 10,000-year period required by the 
Environmental Protection Agency’s health and safety standards.  Some 
of the key elements of this simulation are shown in the illustration. 

This testimony is based on ongoing and published GAO work.  The 
testimony provides the history of DOE’s actions to correct quality 
assurance problems, the status of DOE’s efforts to improve the quality 
assurance program, and preliminary observations on the effect of 
quality assurance problems on DOE’s ability to successfully meet its 
2004 milestone for submitting an application to NRC requesting 
authorization to construct the repository. 


What GAO Found:

DOE’s track record of correcting problems with its quality assurance 
program is less than favorable.  Recurring problems have persisted in 
the program despite DOE’s numerous attempts to correct them.  DOE 
evaluations and NRC oversight activities have concluded that the 
program still falls short of expectations.  

DOE’s 2002 quality assurance improvement plan represents the 
department’s most recent attempt to correct quality assurance 
problems, including those involving the scientific models and software 
codes in the computer simulation that DOE will use to demonstrate the 
safety of the repository.  Because DOE is still in the process of 
implementing this plan, it is too early to determine whether changes 
included in the plan will be effective.  However, notwithstanding 
these changes, DOE has recently identified further quality assurance 
problems, including recurring problems with the data that will be used 
to support the NRC’s decision on whether to authorize DOE to construct 
the repository.  

Based on previously identified weaknesses and recent indications of 
new problems, we are concerned that DOE’s current efforts to improve 
its quality assurance program may not yield the results it hopes for.  
Our observation is further supported by NRC’s recent comment that 
DOE’s quality assurance program has yet to produce outcomes necessary 
to ensure that this program meets NRC requirements.  

www.gao.gov/cgi-bin/getrpt?GAO-03-826T.

To view the product, click on the link above.
For more information, contact Robin Nazzaro
at (202) 512-3841 or nazzaror@gao.gov.

[End of section]

Senators Ensign and Reid:

We are pleased to be here today to discuss the Department of Energy's 
(DOE) quality assurance program for the Yucca Mountain repository 
project. As you know, Yucca Mountain is intended to serve as the 
nation's permanent repository for high-level nuclear waste. DOE is 
currently in the process of preparing an application to the Nuclear 
Regulatory Commission (NRC) for authorization to construct the 
repository, which it expects to submit by December 2004. To ensure that 
DOE can safely construct and operate the repository, NRC requires DOE 
to have a quality assurance program. The quality assurance program is 
designed to include procedures to assure NRC that the information 
submitted to it is verifiable and well documented. Audits and 
management reviews are also built into the program to monitor whether 
workers follow these procedures. In cases where they are not followed, 
DOE must develop and implement corrective actions and monitor their 
effectiveness. An ineffective quality assurance program could 
potentially impede the application process and could precipitate 
potentially adverse health, safety, and environmental effects.

In this context, you asked us to investigate the effectiveness of DOE's 
efforts to improve its quality assurance program. Although we are still 
in the early stages of our investigation, we are prepared today to 
provide 
(1) the history of DOE's actions to correct quality assurance problems, 
(2) the status of DOE's efforts to improve the quality assurance 
program, and (3) preliminary observations on the effect of quality 
assurance problems on DOE's ability to successfully meet its 2004 
milestone for submitting an application to NRC requesting authorization 
to construct the repository.

In summary:

* DOE's track record of correcting problems with its quality assurance 
program is less than favorable. Recurring problems have persisted in 
the program despite DOE's numerous attempts to correct them. DOE 
evaluations and NRC oversight activities have concluded that the 
program still falls short of expectations.

* DOE's 2002 quality assurance improvement plan represents the 
department's most recent attempt to correct quality assurance problems, 
including those involving scientific models and software codes that DOE 
will use to demonstrate the safety of the repository. Because DOE is 
still in the process of implementing this plan, it is too early to 
determine whether changes included in the plan will be effective. 
However, notwithstanding these changes, DOE has recently identified 
further quality assurance problems, including recurring problems with 
the data that will be used to support the NRC's decision on whether to 
authorize DOE to construct the repository.

* Based on previously identified weaknesses and recent indications of 
new problems, we are concerned that DOE's current efforts to improve 
its quality assurance program may not yield the results it hopes for. 
Our observation is further supported by NRC's recent comment that DOE's 
quality assurance program has yet to produce outcomes necessary to 
ensure that this program meets NRC requirements.

Background:

The Nuclear Waste Policy Act of 1982 was enacted to establish a 
comprehensive policy and program for the safe, permanent disposal of 
commercial spent fuel and other high-level radioactive wastes. DOE was 
directed in the act to, among other things, investigate potential sites 
for locating a repository. Amendments to the Act in 1987 directed DOE 
to consider only Yucca Mountain, Nevada, as a potential site for a 
repository. In 2002, the Congress approved the President's 
recommendation of Yucca Mountain as a suitable site for the development 
of a permanent high-level waste repository. The next step in the 
process is for DOE to submit an application to NRC for an authorization 
to construct the repository.

In order to ensure that the information submitted to NRC is verifiable 
and well documented, NRC requires nuclear facilities to develop a 
quality assurance program that includes a process to identify problems, 
develop corrective actions, and monitor the effectiveness of these 
actions. Among other things, such a quality assurance program is 
required to (1) train personnel in quality assurance; (2) inspect 
activities that affect quality; 
(3) establish controls over testing programs and test equipment, such 
as ensuring that this equipment is properly calibrated; (4) establish 
and maintain records, including records documenting the qualifications 
of personnel performing repository work; and (5) verify compliance with 
the rules and procedures of the quality assurance program to determine 
the effectiveness of the program.

In carrying out its responsibility for the Yucca Mountain repository to 
meet the Environmental Protection Agency's (EPA) standards for 
protecting public health and safety, as well as its standards, NRC 
provides consultation and advice to DOE in the project's pre-
application period. NRC officials are located onsite at the Yucca 
Mountain project office where they conduct daily oversight of project 
activities, including observing and commenting on DOE's quality 
assurance audits and preparing bi-monthly reports on the overall status 
of the program. Additionally, DOE and NRC hold quarterly quality 
assurance meetings and conduct exchanges between staff on technical 
issues.

History of Actions Taken to Correct Quality Assurance Problems:

DOE's quality assurance problems at the Yucca Mountain repository site 
date back to the late 1980s. In a 1988 report, we identified 
significant problems with the quality assurance program, noting that it 
failed to meet NRC standards.[Footnote 1] We found that NRC had 
identified many specific concerns from the oversight activities it had 
performed at Yucca Mountain. For example, NRC noted that DOE's heavy 
reliance on contractors and its inadequate oversight of quality 
assurance activities would increase the likelihood that DOE might 
encounter quality-related problems. Furthermore, NRC said that the 
likelihood that the state of Nevada and others would contest the 
licensing proceedings increased the probability that DOE would have to 
defend its quality assurance program and the quality of the work 
performed. NRC noted that DOE's inability to properly defend its work 
could result in additional expense and time-consuming delays as program 
weaknesses are corrected. NRC also found that DOE staff and contractors 
exhibited negative attitudes toward the function of quality assurance, 
noting that participants appeared to lack a full appreciation for what 
it took to get a facility licensed by NRC.

DOE was put on notice of these shortcomings, but the problems 
continued. In its 1989 evaluation of DOE's Site Characterization Plan, 
NRC concluded that DOE and its key contractors had yet to develop and 
implement an acceptable quality assurance program. In March 1992, based 
on progress DOE had made in improving its quality assurance program, 
NRC allowed DOE to proceed with its site characterization work, noting 
that DOE had demonstrated its ability to evaluate and correct quality 
assurance program deficiencies. A year and a half later, however, NRC 
raised concerns with DOE about the acceptability of facility design 
activities requiring quality assurance. NRC reported that it had no 
confidence that DOE's management plan for resolving quality assurance 
issues related to the design activities would work because of DOE's and 
the site contractors' inability to effectively implement corrective 
actions in the past.

DOE renewed its efforts to correct problems with its quality assurance 
program starting in the late 1990s when its own audits at Yucca 
Mountain identified quality assurance problems in three areas: data 
sources, validation of scientific models, and software development. 
First, DOE could not ensure that all the data needed to support the 
scientific models could be tracked back to original sources or that the 
data had been properly collected. Second, DOE had no standardized 
process to develop the scientific models needed to simulate geological 
events. Finally, DOE had no process for ensuring that the software 
being developed to support the models would work. In response to the 
issues raised in the audits, DOE issued a management plan in 1999 that 
prescribed remedies. Following implementation of this plan, DOE 
considered the issues resolved.

Model validation and software development problems, however, resurfaced 
in 2001. New quality assurance audits found that project personnel had 
not followed the required procedures for model development and 
validation or established a timeline for completing the models. In 
addition, these audits identified that project personnel had not 
followed the software development process, prompting a prohibition on 
further software development without prior management approval. 
According to DOE, the significance of these new observations was 
compounded by their similarity to those problems previously identified.

Status of DOE Efforts to Improve Quality Assurance:

In July 2002, DOE provided NRC with a revised plan to correct its 
quality assurance problems at Yucca Mountain, including the problems 
with scientific models and software codes. In constructing the plan, 
DOE conducted an in-depth study of Yucca Mountain's management and work 
environment. The plan outlined five key areas needing improvement. 
Specifically, it noted the need for:

* clarifying roles, responsibilities, accountability, and authority for 
DOE and contractor personnel,

* improving quality assurance processes and clarifying line 
management's quality responsibilities,

* improving DOE and contractor written procedures,

* implementing more effective and consistent corrective action plans to 
preclude recurring quality problems, and:

* improving the work environment where employees can raise program 
concerns without fear of reprisal.

To fully address issues raised in the plan, DOE identified a total of 
72 actions needed to correct the quality assurance program--35 to 
address the five key areas, 12 to address model development issues, and 
25 to address software development issues. DOE recently reported that 
it had completed 41 of the 72 actions. The management plan also 
included performance measures to assess the effectiveness of the 
actions. DOE recently reported, however, that the Yucca Mountain 
project still lacks complete and useful performance measures and stated 
its intention to have the appropriate performance measures in place by 
September 2003.

Since DOE began to implement its latest improvement plan, new quality 
issues have emerged. In March 2003, DOE issued a "stop-work" order 
preventing further use of a procedure intended to help improve DOE and 
contractor quality assurance procedures. According to DOE, they 
cancelled the use of the procedure and reverted back to the existing 
procedure. In April 2003, DOE again found data-related problems similar 
to the data verification problems identified in 1998. For example, DOE 
found that, instead of verifying data back to appropriate sources, 
project scientists had been directed to reclassify the unverified data 
as "assumptions" which do not require verification.

At the April 2003 quality assurance meeting with NRC, DOE highlighted 
several recent improvements to the quality assurance program. These 
improvements included (1) management changes with DOE's primary 
contractor at the site, including a new president and a new director of 
quality assurance, (2) increased line management involvement in quality 
assurance, and (3) the integration of quality engineers with DOE line 
employees. Despite this reported progress, an NRC official at the same 
meeting commented that the quality assurance program had still not 
produced the outcomes necessary to ensure the program is compliant with 
NRC requirements.

Preliminary Observations:

Whether DOE can correct its quality assurance problems in time to meet 
its milestone for submitting an application that is acceptable to NRC 
is not clear. DOE's unsuccessful efforts to address recurring quality 
assurance problems, the identification of new problems since the 
issuance of its 2002 improvement plan, and NRC's recent comment that 
DOE's quality assurance program has yet to produce outcomes necessary 
to ensure that this program meets NRC requirements do not instill much 
confidence that the quality assurance problems will soon be resolved. 
An ineffective quality assurance program could impede the application 
process, leading to time-consuming and expensive delays as weaknesses 
are corrected, or ultimately prevent DOE from receiving authorization 
to construct a repository. Moreover, continued reliance on data that 
are unverifiable and thus could be inaccurate could lead to adverse 
effects in the course of the 10,000-year period required by EPA's 
health and safety standards. At the same time, now that the project has 
shifted from scientific investigation to preparing an application, DOE 
may now have the proper motivation and focus to correct recurring 
quality assurance problems given the integral role that quality 
assurance plays in the application process.

As we continue our investigation, we will work to validate our 
observations and further assess the effectiveness of DOE's efforts to 
improve its quality assurance program.

Thank you, Senators Reid and Ensign. That concludes my testimony. I 
would be pleased to respond to any questions that you may have.

Contacts and Acknowledgments
For further information on this testimony, please contact Ms. Robin 
Nazzaro at (202) 512-3841. Individuals making key contributions to this 
testimony included Lee Carroll, Daniel Feehan, Thomas Kingham, Thomas 
Laetz, Chalane Lechuga, and Jonathan McMurray.

FOOTNOTES

[1] U.S. General Accounting Office, Nuclear Waste: Repository Work 
Should Not Proceed Until Quality Assurance Is Adequate, GAO/RCED-88-159 
(Washington, D.C.: Sept. 29, 1988).