United States Nuclear Regulatory Commission

Office of Public Affairs

Washington, DC 20555

Phone 301-415-8200 Fax 301-415-2234

Internet:opa@nrc.gov

No. 97-026

FOR IMMEDIATE RELEASE

(Friday, February 14, 1997)

NOTE TO EDITORS:

The Nuclear Regulatory Commission has received the two

attached reports from its Advisory Committee on Nuclear Waste.

The reports, in the form of letters, provide comments on:

-- Comments on selected direction-setting issues identified

in NRC's Strategic Assessment of Regulatory Activities.

-- Time of compliance for low-level nuclear waste disposal

facilities.

Attachments:

As stated
January 30, 1997

The Honorable Shirley Ann Jackson

Chairman

U.S. Nuclear Regulatory Commission

Washington, D.C. 20555-0001

Dear Chairman Jackson:

SUBJECT: COMMENTS ON SELECTED DIRECTION-SETTING ISSUES

IDENTIFIED IN NRC'S STRATEGIC ASSESSMENT OF REGULATORY

ACTIVITIES

The Advisory Committee on Nuclear Waste (ACNW) is pleased to

provide its comments on several selected direction-setting issues

(DSIs) that were identified in the U.S. Nuclear Regulatory

Commission's (NRC) Strategic Planning Framework Document released

on September 16, 1996. These issues are an important part of

Phase II, "Rebaselining and Development of Decision Papers of the

Agency's strategic assessment of its regulatory activities." Our

conclusions were reached through deliberative discussions within

the ACNW based on the Phase II document and a briefing on

October 22, 1996, on those DSIs of most interest to the ACNW.

The presentations by Mr. James L. Milhoan, Deputy Executive

Director for Operations and co-chair of the rebaselining

subcommittee, and several members of the rebaselining

subcommittee were useful to the ACNW in focusing its

deliberations on critical topics.

In the following discussion, our comments on seven of the DSIs

pertain to topics that are within the scope of our activities as

specified by the Commission. Where appropriate, our review

comments on the nature and completeness of the background

discussion and decision options are provided for the seven DSIs.

In the interest of limiting the length of this letter while
considering numerous issues, we have purposefully minimized the

depth of the backup discussion. We will be pleased to expand on

topics at your request.

Before discussing specific DSIs, we have the following general

comments regarding the Phase II document:

(1) Rebaselining Nuclear Waste Activities and Related DSIs - We

see the rebaselining effort of the NRC as it relates to

nuclear waste activities to be extremely important and

timely. Regulating the handling, storage, and disposal of

nuclear waste to protect the health and safety of the public

and its environment is a critical role of the NRC, which

permits the use of radioactive materials for a broad range

of uses beneficial to our society. Implementation of

nuclear waste activities and associated regulations,

especially as they relate to storage and disposal, has been

contentious and slow. Rebaselining involving the review of

NRC's role and procedures is timely because

(a) new standards and regulations are being prepared for the

high-level waste program, (b) there is a need to smooth the

interface between standards of the Environmental Protection

Agency (EPA) and NRC regulations, and (c) the decline in

resources for all parties, including potential licensees,

demands a sharper focus on what is demonstrably and

significantly important to public health and safety.

Identification of the DSIs and the introspective view of the

NRC that led to their definition, the broad internal and

external discussion of the DSIs, and the ultimate Commission

decisions on them offer opportunities to establish improved

nuclear waste regulations.

(2) Broadened Role of the NRC in Regulation of Nuclear Material

- The current regulatory environment for radioactive

materials has been developed over a long period and is

administered by a variety of agencies with different

philosophies and concerns. The result is a patchwork of

regulatory legislation that fails to be as consistent,

coherent, effective, and efficient, as possible. The public

generally is confused about radioactive waste regulations

and unaware of the agencies involved and their specific

responsibilities and competence in the regulation of

radioactive materials to protect public health and safety.

Rebaselining by the Commission should have as an ultimate

goal the reorganization of radioactive material regulations

into a coherent and internally consistent assemblage. The

achievement of this goal will be fostered by minimization of

the number of agencies involved. Thus, within the

constraints of a regulatory agency, we encourage the NRC to

think boldly about taking on increased responsibilities for

the regulation of radioactive materials.
4

(3) Omissions in the DSIs - In our review of the DSI papers, we

have identified a few issues that we believe are especially

important to the effective and efficient implementation of

nuclear waste regulations, but are not identified as DSIs.

We realize that these issues were considered in the mix of

nuclear waste issues facing the Commission, but were deemed

insufficiently compelling to warrant individual

identification and discussion as a DSI. Nonetheless, we

wish to bring them to your attention.

(a) Information Management - We are pleased to see

"managing information" identified in NRC's Strategic

Plan as a Core Resource Strategy Arena (Figure 2 of the

Strategic Planning Framework Document). We understand

that this important area has been factored into

rebaselining by implementation of the Information

Technology Management Reform Act and the appointment in

the near future of a chief information officer for the

NRC. This is encouraging because we believe that

internal management of information which includes the

efficient and effective handling, transfer, repositing,

and accessing of both technical and administrative

information is to a significant degree one key to the

success of the NRC in today's data and information-rich

society. The pivotal role of data and information

management in the knowledge-driven Commission may be

cause for the Commission to place greater emphasis on

this issue and its integration into all units and

activities of the NRC.

(b) Cross-Cutting Issues - In reviewing the DSI papers, we

noted that some concerns to the NRC are relevant to

several of the DSIs. Examples of these cross-cutting

issues are mixed waste and greater-than-Class-C (GTCC)

waste. We draw your attention to these because in our

view they are important issues, but may be neglected

because they cross DSI boundaries. They are important

because multiple agencies or divisions within NRC have

overlapping responsibilities that may impede actions by

agencies involved, as well as by licensees. The

resulting confusion may be potentially detrimental to

the public health and safety and lead to

inefficiencies. The NRC should be proactive to

minimize occurrence of such administratively generated

hurdles involving other agencies and should examine its

own structure to ensure that such impediments to

coherent regulatory activities do not exist within the

NRC.

The safe storage and disposal of wastes that have the

attributes of hazardous waste regulated by the
5

Environmental Protection Agency (EPA) and low-level

waste (LLW) regulated by the NRC or one of its

Agreement States remains a perplexing problem. The

ACNW has been concerned with mixed wastes for several

years (e.g., letter to the Commission dated May 3,

1989) and continues to monitor the ongoing activities

and progress of discussions between EPA and the NRC

leading to reconciliation of the conflicting

requirements for storage and disposal of wastes that

fall under the purview of both agencies. We suggest

that these activities be given greater attention in the

strategic planning of the NRC with emphasis on

resolving regulatory overlap with the EPA.

GTCC waste is classified as LLW, but is generally

unacceptable for disposal in the surface or nearsurface structures being designed for LLW. Thus,

storage and disposal of this waste is a problem that

transcends several DSIs. We note that this issue is

discussed in a memorandum from D. L. Morrison,

Director, Office of Nuclear Regulatory Research,

January 14, 1997, "Rulemaking Plan - Interim Storage

for Greater-Than-Class-C Waste, Changes to 10CFR Part

72." Clearly, this problem along with concerns about

mixed waste deserves significant attention in strategic

planning, and thus, the Commission may wish to identify

it as such.

DSI-2: Oversight of the Department of Energy

Actions in the near term by either the Department of Energy (DOE)

or Congress could lead to an expansion of NRC regulatory

authority and responsibilities to include DOE nuclear facilities.

The DSI-2 paper deals with the question of whether the NRC should

seek this authority and responsibility. Further, it provides the

background of how this issue arose, a description and discussion

of the issue, and the relevant options open to the Commission.

We believe this issue should be decided primarily on the basis of

the benefits to the health and safety of the public, but other

considerations include minimizing regulations and overlap among

them, improving regulatory consistency, maximizing overall

regulatory efficiency, and assuring independent oversight and

regulatory surveillance. Our review indicates that the DSI paper

discussion does not fully address the positive aspects of this

issue as they relate to these criteria. Clearly, numerous

problems and concerns are associated with regulating DOE

facilities as developed in the DSI paper, but these are problems

that any agency will face in carrying out the regulatory duties,
6

and the NRC by virtue of its broad nuclear regulatory experience

is best suited to addressing them. As stated in the discussion

of Option 1A, "The Commission's support for assuming broad

authority over DOE facilities would be based on recognition of

the need for external regulation and on the recognition that

NRC's expertise places it in the strongest position of any

existing agency to assume these responsibilities."

Acceptance of Option 1, "Support broad responsibility for NRC

regulation of DOE," has many potential positive attributes. It

could simplify the desirable goal of reorganizing the national

regulatory framework for radioactive materials into a consistent,

integrated entity. These new regulatory responsibilities likely

will result in the need for additional technical expertise within

the Commission, which will then be available to other more

traditional activities of the NRC. Finally, the expansion of NRC

to regulatory functions into DOE nuclear facilities will be less

burdensome to an evolving NRC if the traditional mission and

scope of the Agency is reduced in the future. This reduction may

result from a declining nuclear power generation industry and a

reduction in materials and other licensing perhaps because of a

rising role of Agreement State activities. Despite these very

positive aspects to the NRC broadening its oversight role to

include DOE nuclear facilities, we are aware of the need to

identify clearly the methods, timing, staffing, and funding of

the implementation of this responsibility within the NRC,

including the preparation of pertinent regulations. In addition,

care must be exercised to ensure that current NRC programs and

regulatory responsibilities are not adversely affected by these

new responsibilities.

In conclusion, we suggest that the Commission explore various

derivatives of Option 1, that is, support NRC regulation of DOE,

but we believe that co-regulation should be emphatically avoided

because of the potential for conflicts and confusion in

regulations. Enhancement of public health and safety is neither

evident nor can it be envisioned from multi-party regulation of

the same general activity, materials, or devices. Finally, only

by participating in discussions and decisions regarding the

regulation of DOE facilities will the NRC be poised to see that

its view of needs for public health and safety is implemented.

DSI-4: Relationship with Agreement States

Current rebaselining efforts of the Commission present an

opportunity to review the relationship of the NRC with Agreement

States. The direction of the DSI-4 paper is to consider NRC's

strategy regarding states becoming and remaining Agreement

States. The paper makes a strong case for maintaining a core

licensing and review program and a cadre of competent technical

staff to conduct the program within the NRC. We believe this is
7

essential to fulfill the requirements of the Atomic Energy Act

(AEA) and is consistent with NRC's mission. Furthermore, any

action regarding funding with respect to relationships with

Agreement States must be anchored in maintaining the health and

safety of the public as well as in the Omnibus Budget

Reconciliation Act of 1990. Although we agree with the

discussion regarding the need for maintaining a critical mass of

talent within the agency, the level of licensing activity

required for this as stated in the DSI paper appears to have

little basis in fact and fails to consider an expertise resident

in the agency as a result of related activities.

The conclusion we reach is that some form of Option 3, "Continue

the current Agreement States Program, including adopting current

initiatives," is preferable. We believe the agency should

maintain the authority and responsibilities it has in this area

through the AEA. Further, the hazards of dual regulation as well

indicated by experience in nuclear waste regulation and elsewhere

strongly argue against Option 4, which would lead to coregulation.

We believe it is unfortunate that in the discussion of the

Agreement State Program in the DSI paper, the staff did not take

the opportunity to emphasize additional aspects of this program.

Broadening of this topic could lead to consideration of criteria

used to evaluate the adequacy and compatibility of an Agreement

State's program. We believe that a direct relationship has not

been proven between the evaluation criteria and assurance of the

competency of the States programs and benefits to protection of

public health and safety. One measure of the benefits could be

the number and severity of incidents reported (e.g.,

overexposure, misadministration of radiopharmaceutical and

treatments, loss of control sources). Another measure could be

the cost to potential licensees. Still another concern

associated with the Agreement State Program is the situation in

which State regulations are significantly more stringent than

those of the NRC. This situation is legal, but the lack of

consistency in regulations leads to the public's confusion

regarding the hazards of radioactivity and the validity of

related regulations. In addition, the impact of removal of this

inconsistency on interstate commerce affairs, such as

transportation, would eliminate vagaries caused by local, current

special interests.

We also wish to comment on two of the related issues discussed in

Section VI of this DSI paper. To ensure the compatibility and

adequacy of the Agreement State Program, we believe that it is

essential to incorporate all aspects of the LLW programs of the

States (Section VI.A.). The site review of an LLW disposal

facility is a critical component in the evaluation of the

technical capability of an Agreement State's program. The
8

quality of results and the technical intensity of the Agreement

State review process should be one measure of the adequacy of the

program. In addition, we support NRC's Independent Radiation

Monitoring Program (IRMP) implemented at NRC-licensed facilities,

which is discussed in Section VI.B of the DSI paper. The IRMP

provides important verification of results reported by licensees

and thus serves to assure public health and safety from potential

radioactive releases to the environment.
9

DSI-5: Low-Level Waste

In a recent letter to the Commission (December 29, 1995), the

ACNW concluded that "... in the radioactive waste field, the

management of LLW poses broader, more direct and ubiquitous

potential risks to the health and safety than any other

activity...." As a result, we believe the rebaselining efforts

of the Commission with regard to this DSI are especially

important. Further, this conclusion was critical to our

recommendation in the letter of December 29, 1995, that the NRC

adopt a strong regulatory role in LLW disposal. This

recommendation is supported by an extensive discussion in the

letter of the needs for a Federal presence in this radioactive

waste area and the strengths that the NRC brings to the solution

of the problems of LLW. Thus, we highly recommend Option 2,

"Assume a strong regulatory role in national LLW program," of the

DSI paper. However, the DSI paper implies that a national LLW

disposal program exists. Our view of the current situation is

that, other than in the words of the LLW policy act and its

amendments, a functional coherent national policy is absent. The

volatility of the current LLW activities as associated with the

current and past conflicts in policy, special interests, and

variable practices provides ample evidence for this conclusion.

We are concerned about several items in this DSI paper. We note

the following:

(1) A number of waste types are missing from the discussion. In

our general introductory comments, we noted our concern

about the omission of DSI cross-cutting issues such as mixed

wastes and greater-than-Class-C wastes. As stated

previously, we believe these issues need to be adequately

addressed in the strategic planning of the agency.

(2) NRC's acceptance of long-term storage of LLW, although

attractive as a practical solution to a current problem, may

not be acceptable to the Nation. The current national

policy is to provide final disposal by the present

generation in a manner that does not jeopardize public

health and safety now and in the future. The DSI paper does

not adequately address the requirements for implementing

long-term storage of LLW. We also are concerned about the

rather favorable light placed on interim storage in the DSI

paper presumably because to date no incident has been

reported as a result of storage on the originating site.

However, no evidence exists that onsite storage can be

effective over the expected life of the waste and the

proliferation of storage sites enhances the risk.

(3) We suggest that caution be exercised in using "rules of

thumb" to define waste types in terms of the length of time
10

over which they may be hazardous. In view of the absence of

a de minimis position regarding radioactivity and the broad

application of the no threshold-linear view of the health

effects of radiation, we suggest rules of thumb are a

significant oversimplification.

(4) Finally, we question the acceptance of DOE waste sites as

potential disposal sites for civilian wastes. The DOE sites

were not selected on the basis of criteria used in siting

and licensing civilian disposal facilities, and evidence is

lacking that these sites could meet the standards and

regulations in effect.

In conclusion, we recommend Option 2 of this DSI paper but

encourage additions to

(1) develop a more comprehensive definition of LLW and (2)

evaluate the potential implementation and impact of assured

storage with adequate protection and termination procedures.

DSI-6: High-Level Waste and Spent Fuel

Rebaselining of the NRC comes at a propitious time for the highlevel waste (HLW) program considering the implementation of new

standards by EPA and siting regulations by DOE for the proposed

Yucca Mountain repository and related modifications in the Yucca

Mountain regulations by the NRC. In addition, the viability

assessment of the proposed Yucca Mountain deep-geologic-burial

repository will soon be completed and Congress is considering to

legislate significant changes in the national HLW program.

Before we recommend an option for this DSI, we have several

observations regarding NRC's HLW program and related comments in

this DSI.

(1) The DSI paper lists key specific barriers to the program's

success as identified by the DOE's Office of Civilian

Radioactive Waste Management. Although we agree that some

of these represent significant hurdles for the program, we

believe that a critical barrier pertains to the final one of

the list provided, that is, "General program and budgetary

constraints." Within the scope of this barrier, we find

that changes in the laws and funding levels have led to

instability in planning and conducting the characterization

of the site and design of the repository. This is

exacerbated by the lack of implementation of multiyear

funding plans. These problems are of special concern now

that an achievable program plan, the Viability Assessment,

has been instituted by DOE to achieve the will of Congress

in a reasonable time with a modest budget. The advantages

of a stable program and budget for the successful licensing
11

by the NRC of a HLW repository need to be conveyed to

Congress.

(2) The barriers to DOE's HLW program are important to

understand, but the NRC must recognize that these are not

necessarily the critical hurdles for the NRC to overcome in

the licensing process. The NRC needs to sharpen the focus

of its HLW program beyond the key technical issues and

identify significant problems facing it in regard to the

program.

(3) A related topic is the implied direct connection between

changes in the HLW program of DOE and the NRC. No evidence

exists that a change in the DOE program should lead to a

direct proportional modification in NRC's program. NRC's

role in the HLW program is much different than DOE's. In

fact, a case can be made that some cutbacks in the DOE

program may necessitate increases in the NRC program, for

example, to ensure sufficient data and analysis for the

licensing processes. The effects of reductions in the DOE

program on the NRC licensing plans need clarification.

(4) DOE has made it clear that the viability assessment of the

Yucca Mountain repository is not a technical site

suitability (TSS) evaluation. This evaluation will come

later, but it is unclear what new DOE data gathering and

analyses will be available considering the marked reduction

in operating budget and the likely decrease in key

scientific/technical personnel and related infrastructure.

Thus, we believe prudence requires that the NRC define as

much as possible critical data and analyses it requires to

conduct a comprehensive license review. If some are missing

at the time of the completion of the Viability Assessment,

DOE should be notified of these deficiencies while data and

analyses personnel and programs are intact.

We support Option 3, "Maintaining NRC's existing high-level waste

repository program," in the DSI-6 paper. As we have stated

previously (e.g., in our letter to the Commission, "Comments on

High-Level Waste Prelicensing Program Strategy and Key Technical

Issues," February 16, 1996), we believe in general that the NRC,

through its identification of key technical issues and the

vertical slice approach to the prelicensing program, has taken

appropriate action. Further, we support flexibility in the

program so as to adapt to potential actions that Congress may

take in the near future. In addition to supporting Option 3 we

suggest that serious considerations be given to incorporating the

following suggestions raised in other options:

(1) The use of rulemaking as discussed in Option 2 is a

potentially efficient procedure to deal with contentious
12

issues. Rulemaking may be useful in stabilizing the

repository approval process and reducing NRC-related

uncertainties.

(2) As discussed in Option 2, we encourage the NRC to prepare a

new part of Title 10 of the Code of Federal Regulations

(10CFR) covering the regulations for Yucca Mountain. These

new regulations could avoid the burden of some aspects of

10CFR Part 60 that: (a) are not really pertinent to an

unsaturated repository, (b) have proven to be points of

weakness as they have been reviewed in the prelicensing

period, and warrant modification, such as the subsystem

criteria. The ACNW has developed suggestions regarding time

of compliance (letter to the Commission, "Time Span for

Compliance of the Proposed High-Level Waste Repository at

Yucca Mountain, Nevada," June 7, 1996) that should be

considered in the new regulations together with suggestions

regarding the reference biosphere and critical group, which

are currently under final development by us.

(3) The interim storage of spent fuel appears to be an action

that is increasingly needed. However, Option 5, seems

unnecessarily complex for the purpose of providing storage

facilities until the repository can accept fuel. Such

facilities (dry, onsite storage) exist now and seem to be

quite satisfactory. The need to involve Congress is

unjustified and should be avoided. The polemics that may

arise from a desire to use a centralized facility are likely

to be divisive to the HLW program. Several regional

centralized facilities may be more likely to be acceptable.

Some form of centralized facility for spent fuel will likely

be a requirement if the rate of progress on the underground

repository does not increase. The legislation likely to be

considered by Congress and the possibility of a Presidential

veto suggest that the Yucca Mountain repository program may

be terminated regardless of the results of the technical

site suitability evaluation. Such events would require

identification of an alternate repository site requiring

several years, perhaps a decade or more. The Commission

should consider inclusion in Option 3 the task of ensuring

that centralized, dry, spent-fuel storage facilities can be

readily licensed by a process that is simple and adequate

for the protection of the public and the environment (e.g.,

ground water) for sufficiently long periods. Public

involvement should be ensured, but sufficiently prescribed

to avoid crippling legal maneuvering. The safe license

period for interim storage is an unknown. This is a subject

for study and further deliberation by the Commission.

Concerning the broader issue of managing the nation's HLW, the

Committee found the ideas of DSI-6 on a quasi-government agency
13

and a joint committee oversight function as stimulating and

thought provoking. While we have no position on this issue at

this time, the Committee encourages the Commission to examine

such creative ideas for considering future directions for the

management of the nation's radioactive waste.

In conclusion, rebaselining offers an excellent opportunity to

revamp and streamline the HLW program of the NRC. We offer

several general suggestions and recommend an option for the DSI

that incorporates the present program, and also several

supplementary actions that will speed the licensing process

without weakening it.

DSI-9: Decommissioning - Non-Reactor Facilities

The regulation of and progress in decommissioning of non-reactor

facilities by the NRC are problems requiring significant

Commission efforts and are attracting increasing public scrutiny.

Thus, rebaselining of the Commission's strategic plans in this

area is especially important. In our view the problem that needs

consideration is placement of the scope and system of

decommissioning regulations into a comprehensive strategy for all

"low-level" waste leading to consolidation of regulatory controls

and consistent regulatory criteria on all radioactive materials

(uranium mill tailings, NORM, NARM, decommissioning waste, etc.)

within a single agency, the NRC. Rather than simply addressing

the rather limited focus of the question considered in the DSI-9

paper, we suggest that the Commission would be better served by

first developing a document that specifies the elements of an

adequate decommissioning program for non-reactor facilities in

the manner of our letter to the Commission of July 24, 1996, in

which we developed the elements of an adequate NRC low-level

radioactive waste program.

Elements of an adequate NRC program for decommissioning nonreactor facilities should include:

(1) protection of the safety of the public and preservation of

the environment,

(2) timeliness of actions,

(3) reasonable waste disposal processes and economics,

(4) demonstration to the public of acceptable residual risk, and

(5) fiscal and technical capability of the licensee to

accomplish decommissioning. The ACNW also has indicated in

previous reports that there are several issues key to the

success of the Site Decommissioning Management Plan as
14

described in SECY-90-121 and subsequent revisions. One of

the key items is the quality of the final survey, especially

when levels of residual contamination are close to

background. Other issues include: (1) prioritization of

scheduling of a site for decommissioning based on risk posed

by the site and (2) assurance that wastes generated can be

disposed of in a reasonable fashion (e.g., they are not

mixed wastes). Finally, high priority must be placed on

ensuring consistency of the residual risk criterion (e.g.,

equivalent to 15 mrem/yr for unrestricted access) with a

generally accepted standard that includes the risk of

groundwater contamination.

In view of the preceding discussion, we find none of the options

presented to the Commission totally acceptable. Nonetheless,

elements of some of these options offer useful suggestions.

Option 2, "Change the decommission review process," is worthy of

consideration and testing as specified in the Commission's

preliminary conclusions. However, we are reminded that the

review process is only a tool to ensure that the decommissioning

product will be satisfactory. The product is the important

point. We strongly disagree with Option 6, "Focus on

decommissioning cases in which progress can be made: Transfer

stalled sites to the Environmental Protection Agency's Superfund

Program." The Commission needs to identify those sites posing

the greatest risk to the public and the environment and direct

its resources to those cases. The second part of this option to

transfer stalled sites to EPA is ill-advised. The Commission

should make any decisions to transfer its responsibilities to

other agencies on the basis of furthering the protection of

public health and safety, not simply on cost saving

consideration.

In conclusion, we believe strategic planning with regard to

decommissioning should start with developing a coherent view of

an adequate decommissioning program and the issues inherent in

it. Further, this program should be consistent with regulations

for other low-level waste and should be based on well defined

risk-based protocols. Emphasis should be placed on remediating

sites that pose the greatest risk to public safety and the

environment. Within the regulations flexibility should be

encouraged in remediation to husband resources as long as
15

the public safety is protected as determined by high-quality,

final radiation surveys of the residual contamination.

DSI-12: Risk-Informed, Performance-Based Regulation

The Commission's policy to incorporate risk insights into all

nuclear regulatory activities is most heartening. We believe

that risk-informed, performance-based (RIPB) regulations based

upon probabilistic risk assessment (PRA) are necessary for

efficient protection of the public's health and safety and the

Nation's environment from nuclear waste materials.

Unfortunately, the discussion of RIPB regulation in the DSI-12

paper is too superficial in the nuclear waste area to be useful

in detailing courses of action to be considered. One of our

members, B. John Garrick, sent you a letter, dated January 17,

1997, stating his personal views on this DSI. Our views parallel

those of Dr. Garrick.

The RIPB approach has not been translated into a generic concept

useful in waste management in this DSI paper. Clearly, there is

no adequate definition of RIPB regulation in the waste area that

will be helpful in setting related regulatory protocols. The

basic concepts and tenets necessary for application to the waste

field need to be identified. Critical among these is the need to

understand the processes that result in significant risks and

procedures for specifying these risks and their attendant

uncertainties. This requires a minimum level of information

and/or knowledge of the processes and related phenomena for the

application of the RIPB methodology. Criteria for recognizing

this minimum level need to be developed through sensitivity

studies and other PRA procedures.

We believe that the development of RIPB regulations at the NRC is

especially timely in the waste management area because of, for

example, impending decisions regarding new standards and

regulations for the proposed HLW repository at Yucca Mountain and

the possible regulation of DOE nuclear waste facilities. The

extensive experience of the NRC in performance assessment in

regard to both low- and high-level waste management should be

especially useful in this regard. In terms of options, we

encourage an aggressive move toward RIPB regulation, that is,

Option 3. However, we note that critical regulatory decisions

are needed in the near term in the waste field, so a truly

proactive stance is needed to capitalize on the opportunities of

RIPB. In addition, we support Option 2; that is, we believe it

is necessary to justify the application of RIPB protocols in

terms of benefits to public health and safety.

DSI-22: Research
16

Throughout its history the ACNW has maintained a strong interest

in the research of the NRC and has continued to monitor both the

low- and high-level waste programs of the agency. Although we

have provided critical reviews of the programs, generally we have

been supportive of this research as it contributes to the

effectiveness of NRC's regulatory responsibilities. Thus, we are

pleased to support the research program in the strategic planning

of the Commission. In the waste management area, we see cause

for a more aggressive approach to research, but planning should

be focused on specific topics. We support our colleagues from

the Advisory Committee on Reactor Safeguards in their letter to

you of November 19, 1996, in regard to the need for research to

support NRC's transition to risk-informed, performance-based

regulation.

NRC is a knowledge-driven organization requiring new and

confirmatory information to carry out its mission. Thus,

confirmatory research is critical to its role. We see no need

for NRC to maintain a basic research program that acquires new

fundamental information, for example research supported by the

National Science Foundation. Thus, we question the role of

exploratory research in general, rather we would encourage the

use of anticipatory research wherein topics are identified for

potential future use by the NRC that require a somewhat longer

time to research and evaluate than the shorter term applied or

confirmatory research. In addition to these general statements

and concerns, we raise the following points and observations

regarding the DSI:

(1) The DSI does not resolve the issue of who should perform NRC

research. There are three possibilities: staff at NRC

headquarters, contractors at the Center for Nuclear Waste

Regulatory Analysis (CNWRA); and researchers at Universities

and research centers. We believe that a strong research

program at NRC headquarters is inappropriate. However, a

relatively small cadre of staff with special expertise in

selected core technical areas should be maintained to serve

as technical consultants, mentors, and tutors to the staff.

These staff will likely have strong research experience in

their background, but not necessarily currently involved

directly in anticipatory or confirmatory research. The

research performed at the CNWRA has been responsive to the

needs of NRC's HLW program and has been done efficiently.

We think that the NRC should continue to support the work at

CNWRA. Finally, we encourage university-based research as

an integral component of the NRC research program. The

Educational Grant Program, with an increase in maximum

funding level to $100,000/yr, will not only make available

to the Commission expertise and facilities that are

unavailable internally, but will aid in the support and
17

encouragement of students who form the future cadre for the

protection of public health and safety from nuclear waste.

(2) The implication of the DSI is that there is a direct linkage

between current NRC licensing activities and the quantity of

research that is needed. The lack of current LLW licensing

within the NRC is cited as an example. This view requires

reconsideration. Although it may be defensible from a

short-term budget standpoint, such a policy is based on the

erroneous assumption that research can be easily started up.

Further, in the case of LLW, although the NRC has no

licensing actions on the immediate horizon, the Agreement

States do face near-term licensing. Agreement States have

neither the broad role of the NRC nor the resources to

conduct research and thus depend on the NRC for LLW

research.

(3) The ACNW generally has continued to support participation in

international research programs related to nuclear waste.

The potential benefits far outweigh the cost.

Thus, we support Option 7, that is, continuing to actively

participate in international safety programs.

(4) There is a need for greater discipline within the NRC

regarding the selection of research topics in nuclear

waste. A principal goal of research should be to provide the

understanding of the phenomena and processes that lead to

risk to public health and safety and the Nation's

environment, quantification of this risk under applicable

source and site conditions, and definition of attendant

uncertainties. Topics should be selected for research

programs accordingly. There are two general classes of

research topics at the NRC: (1) research pertinent to

licensing considerations of a particular facility (e.g.,

site characterization, inventory and its chemistry,

corrosion of engineered barriers, and waste containers) and

(2) research topics pertinent to the development of

regulations, including generic topics such as health effects

of low levels of radiation, biotransport of radioactive

elements, food chain studies, and role of colloids. We

believe there are many current research needs at the NRC

that can readily be identified. Considerable confirmatory

research is needed to ensure that license applicant's

results are viable and sound. Emphasis should be placed on

research in potentially risk-sensitive and controversial

areas. The Commission in its strategic planning should

provide guidelines for the selection of research topics

based on the above discussion.
18

In conclusion, we believe an aggressive research program is

needed to fulfill the responsibilities of the NRC to the nation.

However, it is not clear that a basic research program is a

requirement. Rather, a focused approach to research is needed,

within guidelines established by the Commission that involves

both short- and long-term programs and deals both with immediate

licensing agendas and generic problems that contribute to the

NRC's transition to risk-informed, performance-based regulation.

Conclusion

In conclusion, we have presented general comments on the Phase II

NRC document, "Strategic Assessment and Rebaselining Initiative -

Stakeholder Involvement Process Papers," of September 16, 1996,

and specific comments on seven DSIs detailed in the Phase II

document. These seven DSIs are related to regulating the

handling, storage, and disposal of nuclear waste and as such fall

within the purview of the ACNW.

We present numerous positive comments related to the

rebaselining efforts and options submitted to the Commission in

regard to nuclear waste issues. We find that discussions of

several of the DSIs and the identified in the DSI papers do not

provide, in our view, a comprehensive range of opinions or

options. Our discussions attempt to fill these voids and suggest

courses of action for the Commission to take in its rebaselining

efforts. Clearly, our discussions covering this broad range of

topics do not comprehensively treat all the issues or arguments.

We will be pleased to provide more exhaustive discussions of any

of the topics upon your direction.

Thank you for the opportunity to contribute to this important

process in the strategic

planning for the future role of the NRC.

Sincerely,

/s/

Paul W. Pomeroy

Chairman, ACNW
19

February 11, 1997

The Honorable Shirley Ann Jackson

Chairman

U.S. Nuclear Regulatory Commission

Washington, D.C. 20555-0001

Dear Chairman Jackson:

SUBJECT: TIME OF COMPLIANCE FOR LOW-LEVEL NUCLEAR WASTE DISPOSAL

FACILITIES
20

In this letter, we communicate the observations and recommendations of the Advisory

Committee on Nuclear Waste (ACNW) on the time span for compliance of low-level waste

(LLW) disposal sites. This letter complements our letter of June 7, 1996, on "Time Span

for Compliance of the Proposed High-Level Waste Repository at Yucca Mountain,

Nevada," in which we proposed a set of general principles for establishing the time span

for compliance of nuclear waste facilities. Building on these principles, we recommend a

two-part approach to establishing the time frame for LLW compliance. The first part utilizes

a site-specific time span based on an analysis to determine the time at which release and

transport of the more mobile radionuclides produce a peak dose to the critical population

group. The second part is a qualitative evaluation, not requiring a specific measure of

compliance, which is used to identify any significant deficiencies in the performance of the

disposal system.

Our observations and recommendations are derived from a working group meeting on

"Regulatory Time of Compliance for Radioactive Waste Disposal" held during the 82nd

meeting of the ACNW on March 27, 1996, at which the time of compliance for both highand low-level waste facilities was discussed; a presentation by the Office of Environmental

Policy and Assistance in the Office of the Environment, Safety, and Health of the U.S.

Department of Energy (DOE) at the 84th meeting of the ACNW on June 27, 1996; and

remarks made at both the 84th and 85th meetings of the ACNW on June 27 and August

22, 1996, respectively, by officials of several States involved in developing LLW facilities.

The Problem

Performance assessment provides useful information on how an LLW facility may perform

over a period of time. Thus, performance assessment is an important tool for

demonstrating LLW regulatory compliance as specified in Part 61 of Title 10 of the Code

of Federal Regulations (10 CFR Part 61) and related guidance of the U.S. Nuclear

Regulatory Commission (NRC). A critical element of a performance assessment is the

length of time over which the calculated dose should be compared to the specified

standard or regulation. This is the time span of compliance. The current NRC regulation

for LLW disposal facilities (10 CFR Part 61) does not specify this time span. The rule is

concerned with minimum times of analyses. For example, 10 CFR 61.7(a)(2) states, "In

choosing a disposal site, characteristics should be considered in terms of the indefinite

future and evaluated for at least a 500-year time frame." This statement is, in part, the

origin of the misconception that 10 CFR Part 61 is a "500-year rule," which only requires

a demonstration of compliance for this time period. A time specification of 10,000 years

is included in the draft Branch Technical Position (BTP) on Low-Level Waste Performance

Assessment and was included in the Draft Environmental Impact Statement (DEIS) for 10

CFR Part 61 (NUREG-0782). However, the Final Environmental Impact Statement (FEIS)

for 10 CFR Part 61 (NUREG-0945) does not include a compliance period.

The DOE is preparing radiation protection requirements for the public from its near-surface

disposal of LLW and residual radioactivity in soil. DOE officials have informed us that they

intend to promulgate regulations (10 CFR Part 834) in the near future. The DOE Format
21

and Content Guide and Standard Review Plan for DOE Low-Level Waste Disposal Facility

Performance Assessments specifies a time of compliance of 1,000 years. This decision

is not based on a scientific or technical rationale but rather is believed to be consistent with

the intergenerational equity principle. This principle states that no generation should

needlessly deprive its successors of the opportunity to enjoy a quality of life equivalent to

its own and is an often-cited benchmark in establishing policy on time of compliance. In

developing guidance on time of compliance, DOE points out that dose analyses beyond

1,000 years could be used in evaluation of facility alternatives, but that these results should

be used with caution because of the potential uncertainties. This two-part approach to time

of compliance using a shorter, quantitative evaluation followed by a longer, qualitative

consideration is widely employed in other national and international regulations and

guidance.

The ACNW has a long-standing interest in the development of guidance by the NRC for

LLW performance assessment, as evidenced in numerous discussions with the Division

of Waste Management, Office of Nuclear Material Safety and Safeguards, and several

letters over the past half decade to the Chairman of the Commission. The time frame for

performance assessment has been of special concern. In our letter of June 3, 1994

(Appendix A), we pointed out the need for a specified time of compliance in the LLW

regulations. Later, in a letter to the Chairman of the Commission on regulatory policy

issues in LLW performance assessment dated June 28, 1995 (Appendix B), the Committee

again suggested the need for a maximum time frame for analyzing the safety of an LLW

disposal site. The Committee pointed out that much larger quantities of long-lived

radionuclides are being disposed of as LLW than was anticipated in the DEIS/FEIS,

resulting in the potential for peak dose times in excess of 10,000 years. A letter received

by the Committee from James M. Taylor, Executive Director for Operations, dated May 17,

1996 (Appendix C), confirms the staff's continuing interest in this topic. Subsequently, a

working group on regulatory time of compliance and deliberations and discussions led to

our letter of June 7, 1996, in which we outlined a set of principles for establishing a

regulatory time of compliance for the proposed high-level waste repository at Yucca

Mountain.

Considerations Regarding LLW Disposal Time of Compliance

We seek to devise a rational basis for selecting a time of compliance that relates the

characteristics of a disposal site and its impact on public health and safety. The principles

stated in our letter of June 7, 1996 (Appendix D) provide a rational approach for

establishing a time span of compliance. The period of time must be short enough so that

meaningful evaluations can be made without excessive uncertainty, but long enough to

permit the evaluation of processes that may lead to the loss of integrity of the facility and

transport of the radionuclides to the critical group. These principles need to be sufficiently

generic so that they can be applied to a variety of LLW disposal facilities.

The regulatory principles involve a two-part approach. In the first part, the time of

compliance should be established by the estimated time at which transport of the more
22

mobile radionuclides produce a peak dose to the critical group. This time estimate is

based on a systems analysis using data from site characterization, modeling, analogs, and

experimental studies. The specified time of compliance is not a direct measure of the

facility's performance, but defines the span of time over which the performance of the

facility is assessed by comparing the calculated dose with the standard. This definition

leads to an apparent paradox in that a disposal facility with superior containment qualities

has a longer time of compliance than a site of lesser quality. However, in the proposed

methodology, the time of compliance is not a measure of safety, but is the time at which

the calculated dose from the facility must meet the standard. The goal is not to set a

specific time that would be enforced like the dose standard. On the contrary, the objective

is to allow the regulator to evaluate the dose versus time relationship from the site-specific

performance assessment calculations that will serve as a benchmark of facility

performance and an indicator of long-term safety. The specified time of compliance may

be of such a long duration that the procedure could lead to the calculated doses having

unacceptably large uncertainties. In this case, a time of compliance shorter than that

calculated on the basis of transport should be specified using the time history of the source

term hazard as a criterion.

The second part of our proposed regulatory approach generally pertains to facilities for

which the highest dose occurs as a result of less mobile radionuclides. These instances

require calculation of a point estimate of the dose to the critical group at the time of overall

peak dose, which is compared with the standard. The latter comparison should be only

qualitative because of the anticipated long periods required to reach the peak dose and the

attendant uncertainties in both the time period and dose. This calculation permits the

identification of important performance factors that define risk to the critical group.

Ameliorating actions such as modification of the source term or waste form may be needed

to minimize the difference between the calculated dose and the standard. We believe, as

stated in our letter of June 7, 1996, that this latter comparison should not become a de

facto regulation because of the potential for large uncertainties in the assessment of

performance and risk. In addition, as stated in our previous communication on time of

compliance, the specified time is strongly influenced by assumptions about the reference

biosphere and the critical group. As such, the procedures for identifying and documenting

the assumptions for a specific facility are an integral part of the regulations and guidance.

Several significant features that are unique to the LLW program should be recognized.

ˇ Surface and near-surface LLW facilities are subject to deleterious surficial

processes such as erosion and flooding. Rates of surficial processes may be

altered by climatic change. Such considerations should be factored into the

performance assessment.

ˇ In many areas of the Nation, LLW facility sites could be located within a few tens of

meters of the saturated zone, resulting in relatively short periods for water to move

from the surface through the facility and through the unsaturated zone to the water

table. This situation, coupled with the possibility of a limited distance to the critical
23

group from the disposal site in many regions of the United States, may lead to

relatively short times of compliance when the waste containers and engineered

barriers of the facility fail.

ˇ The concrete vault disposal system proposed in some LLW facilities may delay

releases for long periods, but the time period over which the concrete is able to

withstand degradation is not well established.

ˇ The potential for significant quantities of certain long-lived radionuclides, such as

uranium in near-surface LLW sites, is greater than was anticipated in the DEIS for

10 CFR Part 61. The result is that peak doses may not occur until a long period of

time has passed, perhaps tens or hundreds of thousands of years. In addition, the

risk from some decay products may be higher than that of the parent. If the

calculated doses at very long periods exceed the standard by significant factors, the

LLW disposal system may require modification.

Recommendations for an LLW Disposal Time of Compliance

On the basis of the regulatory principles and observations discussed above, the ACNW

recommends that the LLW disposal regulations or guidance include a generic, two-part

approach to the time of compliance used in assessing the capability of an LLW site to

protect the public health and safety. This approach will lead to different compliance times,

depending on the waste, the facility, the associated geosphere, the specified reference

biosphere, and the critical group.

ˇ The first part of the approach requires compliance with the numerical standard over

a specified period of time. This time span should be no shorter than an estimate

of the anticipated time it takes for the more mobile radionuclides to produce a peak

dose to the critical group and no longer than a time period over which scientific

extrapolations can be convincingly made. This time period should be determined

on the basis of site-specific characteristics of the entire disposal system using

modeling, analog studies, and results from laboratory and in situ experiments. If the

disposal system fails to meet the standard during the specified time period,

ameliorating actions should be required or the site should be rejected.

ˇ The time period of compliance must be defined in concert with the reference

biosphere and the critical group. Thus, the regulations also must include

requirements and guidance for defining the latter on a facility-specific basis using

known site characteristics and effects of long-term processes that are technically

supported.

ˇ In certain cases, the calculated time of compliance should be replaced with a

maximum time of compliance such that uncertainties in performance assessment

can be reasonably bounded.
24

ˇ The second part of the compliance regulation is designed to be used in evaluation

of the robustness of the facility over the range of external processes and events that

may affect the performance of the facility over long time periods. This evaluation

also will ensure that no significant changes in the dose from the disposal site will

occur in the near term after the calculated time of compliance. Estimates of the

peak dose from the facility beyond the time of compliance are qualitatively

compared with the dose standard. This part should not become a de facto

regulation.

Summary

The ACNW recommends implementation of regulations that will establish procedures and

guidelines for setting the regulatory time of compliance for LLW disposal facilities. The

recommendation proposes a two-part approach that is based on generic regulatory

principles modified for LLW. This approach is supportive of the two-part program being

discussed by the NRC staff and views held by a variety of national and international

regulatory agencies.

We believe that our recommendations can be used to shape a robust and defensible

regulation.

Sincerely,

/s/

Paul W. Pomeroy

Chairman, ACNW

Appendix A

Excerpt from ACNW letter to Chairman Selin, dated June 3, 1994, entitled

"Review of the Low-Level Radioactive Waste Performance Assessment

Program," Item B.6 concerning time of compliance.

B. Branch Technical Position

6. The Committee believes that there is significant

uncertainty about the required time frame for PA.

The presently used arbitrary numerical values

(e.g., 10,000y) lack bases in either standards or

regulations. The Committee recommends that,

as a minimum, the time frame for site-specific

PA should be guided by the dose-time profile as

depicted in the draft BTP and used in

conjunction with an explicit upper time limit. The
25

NRC staff is urged to develop a position on the

appropriate time frame and submit it to the

Commission for discussion, review, and

approval.

Appendix B

Excerpt from ACNW letter to Chairman Selin, dated June 28, 1995, entitled "Regulatory

Issues in Low-Level Radioactive Waste Performance Assessment."

TIME FRAME FOR PERFORMANCE ASSESSMENT

The Committee believes there is merit in choosing a generic maximum time

frame for analyzing the safety of an LLW facility. We do caution the staff

against letting time-frame limits detract from focus on the actual performance

of a site-specific LLW facility.

One important attribute of the LLW field is the variability in the radionuclide

content of LLW. For example, much larger quantities of long-lived

radionuclides are being disposed of as low-level waste than was previously

anticipated. The result is that at some sites, peak doses will occur at times

longer than 10,000 years. We believe the application of peak dose

calculations to be an important issue and plan to report to you on this subject

after a timely review of this topic. Again, the Committee urges the principle

of completeness by assessing first the safety of a specific facility and then

being satisfied that it is in compliance with the regulations. Nevertheless, the

BTP should identify a time period such as 10,000 years for which

performance assessment of an LLW site should be completed and beyond

which such analyses should not be required.

Appendix C

Excerpt from enclosure to letter of May 17, 1996, entitled "Regulatory Issues in Low-Level

Waste Disposal Performance Assessment," from James M. Taylor, Executive Director for

Operations, to the ACNW.

Regulatory Issue 3. - Timeframe for PA

The staff appreciates ACNW's support on the selection of a 10,000-year

generic maximum timeframe for analyzing the safety of an LLW facility. The

staff shares ACNW's concern that a generic timeframe should not distract

from assessing actual facility performance in cases where large amounts of

long-lived radionuclides are being disposed of. In particular, the staff is

concerned about the appropriateness of disposing of very large quantities of
26

uranium at near-surface LLW disposal facilities and believes that further

discussions on uranium disposal are needed with U.S. Department of Energy

and U.S. Environmental Protection Agency staff.

Appendix D

Excerpt from ACNW letter to Chairman Jackson, dated June 7, 1996, entitled "Time Span

For Compliance of the Proposed High-Level Waste Repository at Yucca Mountain,

Nevada."

Regulatory Principles for Establishing the Time Span for Compliance

On the basis of the preceding considerations, the ACNW recommends that

a two-part approach to definition of the compliance period be established for

nuclear waste facilities. The first part involves the following three elements:

(1) The time period for compliance should be based on the estimated

time for release and transport of the radionuclide contaminants to

reach the critical group. This time estimate should be based on

geologic, geochemical, and hydrologic characterization of the site and

its environs, as well as regional study of geologic processes and their

potential effects on the site, and total systems performance

assessment. This estimate must confirm the ability of the repository

system to retain radionuclides for a minimum of several thousand

years. The selection of the time of compliance must be evaluated

along with the specification of the reference biosphere and critical

group.

(2) The reference biosphere and the lifestyles of the critical group should

be defined on the premise that no major changes will occur in society

that will significantly affect their lifestyles as they relate to risk from the

repository and that the climate can be reasonably bounded. The

minimum distance from the boundary of the repository to the critical

group will be a major decision.

(3) The compliance time should be sufficiently short such that

extrapolations of significant processes and their rates can be made

robustly with reasonably modest uncertainties.

The second part of the compliance period regulations should be based on

assessments extending from the specific compliance period to the calculated

time of the peak risk to the critical group. There is no definitive measure of

compliance in the sense of a numeric match between a standard and the

calculated peak risk, and this second part should not be allowed to become
27

a de facto regulation. A comparison between the standard used in the first

part and the calculated peak risk should lead to identification of important

performance factors that define risk to the critical group. Depending upon

the extent to which the peak risk exceeds the standard, ameliorating actions

to reduce this difference should be initiated, such as increasing the integrity

of the engineered barriers, improving site characterization to more closely

bound uncertainties, or, in the extreme, abandoning the candidate site.

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