Public Health and Environmental Radiation Protection Standards for Yucca Mountain, NV, 49014-49065 [05-16193]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 161 (Monday, August 22, 2005)]
[Proposed Rules]
[Pages 49014-49065]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16193]



[[Page 49013]]

-----------------------------------------------------------------------

Part II





Environmental Protection Agency





-----------------------------------------------------------------------



40 CFR Part 197



Public Health and Environmental Radiation Protection Standards for 
Yucca Mountain, Nevada; Proposed Rule

Federal Register / Vol. 70, No. 161 / Monday, August 22, 2005 / 
Proposed Rules

[[Page 49014]]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 197

[OAR-2005-0083; FRL-7952-1]
RIN 2060-AN15


Public Health and Environmental Radiation Protection Standards 
for Yucca Mountain, NV

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: We, the Environmental Protection Agency (EPA), are proposing 
to revise certain of our public health and safety standards for 
radioactive material stored or disposed of in the potential repository 
at Yucca Mountain, Nevada. Section 801(a) of the Energy Policy Act of 
1992 (EnPA, Pub. L. 102-486) directed us to develop these standards. 
These standards (the 2001 standards) were originally promulgated on 
June 13, 2001 (66 FR 32074). Section 801 of the EnPA also required us 
to contract with the National Academy of Sciences (NAS) to conduct a 
study to provide findings and recommendations on reasonable standards 
for protection of the public health and safety. The health and safety 
standards promulgated by EPA are to be ``based upon and consistent 
with'' the findings and recommendations of NAS. On August 1, 1995, NAS 
released its report (the NAS Report), titled ``Technical Bases for 
Yucca Mountain Standards.'' In promulgating our standards, we 
considered the NAS Report as the EnPA directs.
    On July 9, 2004, in response to a legal challenge by the State of 
Nevada and the Natural Resources Defense Council, the U.S. Court of 
Appeals for the District of Columbia Circuit vacated portions of our 
standards that addressed the period of time for which compliance must 
be demonstrated. The Court ruled that the time frame for regulatory 
compliance was not ``based upon and consistent with'' the findings and 
recommendations of the NAS and remanded those portions of the standards 
to us for revision. These remanded provisions are the subject of 
today's action.
    Today's proposal incorporates multiple compliance criteria 
applicable at different times for protection of individuals and in 
circumstances involving human intrusion into the repository. Compliance 
will be judged against a standard of 150 microsievert per year (15 
millirem per year) committed effective dose equivalent at times up to 
10,000 years after disposal and against a standard of 3.5 millisievert 
per year (350 millirem per year) committed effective dose equivalent at 
times after 10,000 years and up to 1 million years after disposal. 
Today's proposal also includes several supporting provisions affecting 
DOE's performance projections. DOE will measure the median of the 
distribution of doses against the dose standard beyond 10,000 years, 
will calculate doses using updated scientific factors, and will 
incorporate specific direction on analyzing features, events, and 
processes that may affect performance.
    Section 801(b) of the EnPA requires the Nuclear Regulatory 
Commission (NRC) to modify its technical requirements for licensing of 
the Yucca Mountain repository to be consistent with the standards 
promulgated by EPA. NRC did incorporate EPA's Yucca Mountain standards 
into its licensing regulations and the regulatory time frame provision 
of these was similarly struck down by the Court of Appeals. Once 
revised regulatory time frame components of our standards have been 
promulgated, NRC must revise its licensing regulations to be consistent 
with our revised standards. The Department of Energy (DOE) plans to 
submit a license application providing a compliance demonstration. The 
NRC will determine whether DOE has demonstrated compliance with NRC's 
licensing regulations, which must be consistent with our standards, 
prior to granting or denying the necessary licenses to dispose of 
radioactive material in Yucca Mountain.

DATES: Comments must be received on or before October 21, 2005.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2005-
0083, by one of the following methods:
    1. Electronically. If you submit an electronic comment as 
prescribed below, EPA recommends that you include your name, mailing 
address, and an e-mail address or other contact information in the body 
of your comment. Also include this contact information on the outside 
of any disk or CD-ROM you submit, and in any cover letter accompanying 
the disk or CD-ROM. This ensures that you can be identified as the 
submitter of the comment and allows EPA to contact you in case we 
cannot read your comment due to technical difficulties or we need 
further information on the substance of your comment. EPA's policy is 
that we will not edit your comment, and any identifying or contact 
information provided in the body of a comment will be included as part 
of the comment that is placed in the official public docket, and made 
available in EPA's electronic public docket. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, we may not be able to consider your comment.
    i. Federal eRulemaking Portal: https://www.regulations.gov. Follow 
the on-line instructions for submitting comments.
    ii Agency Web site: EPA's preferred method for receiving comments 
is via its website, EDOCKET. EDOCKET is an ``anonymous access'' system, 
which means EPA will not know your identity, e-mail address, or other 
contact information unless you provide it in the body of your comment. 
Go directly to EDOCKET at https://www.epa.gov/edocket, or, from the EPA 
Internet Home Page (www.epa.gov), select ``Information Sources'' (in 
the left column), then ``Dockets,'' then ``EPA Dockets'' (in the first 
paragraph). For either route, then click on ``Quick Search'' (in the 
left column). In the search window, type in the docket identification 
number OAR-2005-0083. Please be patient, the search could take about 30 
seconds. This will bring you to the ``Docket Search Results'' page. At 
that point, click on OAR-2005-0083. From the resulting page, you may 
submit a comment by clicking on the balloon icon in the ``Submit 
Comment'' column and following the subsequent directions.
    iii. E-mail: Comments may be sent by electronic mail (e-mail) to a-
and-r-docket@epa.gov, Attention Docket ID No. OAR-2005-0083. In 
contrast to EPA's electronic public docket, EPA's e-mail system is not 
an ``anonymous access'' system. If you send an e-mail comment directly 
to the Docket without going through EPA's electronic public docket, 
EPA's e-mail system automatically captures your e-mail address. E-mail 
addresses that are automatically captured by EPA's e-mail system are 
included as part of the comment that is placed in the official public 
docket, and made available in EPA's electronic public docket.
    2. Surface Mail. Send your comments to: EPA Docket Center (EPA/DC), 
Air and Radiation Docket, Environmental Protection Agency, EPA West, 
Mail Code 6102T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 
Attention Docket ID No. OAR-2005-0083.
    3. Hand Delivery or Courier. Deliver your comments to: Air and 
Radiation Docket, EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 
Constitution Ave., NW., Washington, DC, Attention Docket ID No. OAR-
2005-0083. Such deliveries are only

[[Page 49015]]

accepted during the Docket Center's normal hours of operation.
    4. Facsimile. Fax your comments to: 202-566-1741, Attention Docket 
ID. No. OAR-2005-0083.
    Instructions for submitting information to EDOCKET: Direct your 
comments and information to Docket ID No. OAR-2005-0083. It is 
important to note that EPA's policy is that public comments, whether 
submitted electronically or in paper, will be made available for public 
viewing in EPA's electronic public docket as EPA receives them and 
without change, unless the comment contains copyrighted material, CBI, 
or other information whose disclosure is restricted by statute. When 
EPA identifies a comment containing copyrighted material, EPA will 
provide a reference to that material in the version of the comment that 
is placed in EPA's electronic public docket. The entire printed 
comment, including the copyrighted material, will be available in the 
public docket.
    Certain types of information will not be placed in EDOCKET. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility. EPA intends to work towards providing electronic 
access to all of the publicly available docket materials through EPA's 
electronic public docket.
    The EPA EDOCKET and the federal regulations.gov websites are 
``anonymous access'' systems, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through EDOCKET or regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.
    For additional information about EPA's electronic public docket 
visit EPA Dockets online or see 67 FR 38102, May 31, 2002.
    Docket: The official docket is the collection of materials that is 
available for public viewing 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. 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.
    All documents in the docket are listed in the EDOCKET index at 
https://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available since it will not be placed in 
EDOCKET. That is, although a part of the official docket, EDOCKET does 
not include Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Information 
claimed as CBI and other information whose disclosure is restricted by 
statute, which is not included in the official public docket, will not 
be available for public viewing in EPA's EDOCKET. In addition, EPA 
policy is that copyrighted material will not be placed in EPA's 
EDOCKET, but will be available only in printed, paper form in the 
official public docket. To the extent feasible, publicly available 
docket materials will be made available in EPA's EDOCKET. When a 
document is selected from the index list in EDOCKET, the system will 
identify whether the document is available for viewing. Although not 
all docket materials may be available electronically, you may still 
access any of the publicly available docket materials through the 
docket facility. EPA intends to work towards providing electronic 
access to all of the publicly available docket materials through EPA's 
electronic public docket.

FOR FURTHER INFORMATION CONTACT: Ray Clark, Office of Radiation and 
Indoor Air, Radiation Protection Division (6608J), U.S. Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 202-343-9601; fax number: 202-343-2305; e-mail 
address: clark.ray@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    The DOE is the only entity regulated by these standards. Our 
standards affect NRC only because, under Section 801(b) of the EnPA, 42 
U.S.C. 10141 n., NRC must modify its licensing requirements, as 
necessary, to make them consistent with our final standards. Before it 
may accept waste at the Yucca Mountain site, DOE must obtain a license 
from NRC. DOE will be subject to NRC's modified regulations, which NRC 
will implement through its licensing proceedings.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. If you submit CBI, clearly mark the part or all 
of the information that you claim to be CBI. For CBI information on a 
disk or CD-ROM that you mail to EPA, mark the outside of the disk or 
CD-ROM as CBI and then identify electronically within the disk or CD-
ROM the specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. You may find the following 
suggestions helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.

[[Page 49016]]

    3. Provide any technical information and/or data you used that 
support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at your estimate.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternatives.
    7. Make sure to submit your comments by the comment period deadline 
identified.
    8. Respond to specific questions from the Agency.
    9. To ensure proper receipt by EPA, identify the appropriate docket 
identification number in the subject line on the first page of your 
response.

C. How Can I View Items in the Docket?

    1. Information Files. EPA is working with the Lied Library at the 
University of Nevada-Las Vegas (https://www.library.unlv.edu/about/
hours.html#desks) and the Amargosa Valley, Nevada public library 
(https://www.amargosavalley.com/Library.html) to provide information 
files on this rulemaking. These files are not legal dockets, however 
every effort will be made to put the same material in them as in the 
official public docket in Washington, DC. The Lied Library information 
file is at the Research and Information Desk, Government Publications 
Section (702-895-2200). Hours vary based upon the academic calendar, so 
we suggest that you call ahead to be certain that the library will be 
open at the time you wish to visit (for a recorded message, call 702-
895-2255). The other information file is in the Public Library in 
Amargosa Valley, Nevada (phone 775-372-5340). As of the date of 
publication, the hours are Monday, Wednesday, and Friday (9 a.m.-5 
p.m.); Tuesday and Thursday (9 a.m.-7 p.m.); and Saturday (9 a.m.-1 
p.m.). The library is closed on Sunday. These hours can change, so we 
suggest that you call ahead to be certain when the library will be 
open.
    2. Electronic Access. An electronic version of the public docket is 
available through EPA's electronic public docket and comment system, 
EPA Dockets (EDOCKET). You may use EDOCKET to submit or view comments, 
access the index listing of the contents of the official public docket, 
and to access those documents in the public docket that are available 
electronically. To access the docket either go directly to https://
www.epa.gov/edocket/ or, from the EPA Internet Home Page (www.epa.gov), 
select ``Information Sources'' (in the left column), then ``Dockets,'' 
then ``EPA Dockets'' (in the first paragraph). For either route, then 
click on ``Quick Search'' (in the left column). In the search window, 
type in the docket identification number OAR-2005-0083. Please be 
patient, the search could take about 30 seconds. This will bring you to 
the ``Docket Search Results'' page. At that point, click on OAR-2005-
0083. From the resulting page, you may access the docket contents 
(e.g., OAR-2005-0083-0002) by clicking on the icon in the ``Rendition'' 
column.

D. Can I Access Information by Telephone or Via the Internet?

    Yes. You may call our toll-free information line (800-331-9477) 24 
hours per day. By calling this number, you may listen to a brief update 
describing our rulemaking activities for Yucca Mountain, leave a 
message requesting that we add your name and address to the Yucca 
Mountain mailing list, or request that an EPA staff person return your 
call. In addition, we have established an electronic listserv through 
which you can receive electronic updates of activities related to this 
rulemaking. To subscribe to the listserv, go to https://lists.epa.gov/
read/all_forums. In the alphabetical list, locate ``yucca-updates'' 
and select ``subscribe'' at the far right of the screen. You will be 
asked to provide your e-mail address and choose a password. You also 
can find information and documents relevant to this rulemaking on the 
World Wide Web at https://www.epa.gov/radiation/yucca. We also recommend 
that you examine the preamble and regulatory language for the earlier 
proposed and final rules, which appeared in the Federal Register on 
August 27, 1999 (64 FR 46976) and June 13, 2001 (66 FR 32074), 
respectively.

E. What Documents Are Referenced in Today's Proposal?

    We refer to a number of documents that provide supporting 
information for our Yucca Mountain standards. All documents relied upon 
by EPA in regulatory decisionmaking may be found in our docket (OAR-
2005-0083). Other documents, e.g., statutes, regulations, proposed 
rules, are readily available from public sources. The documents below 
are referenced most frequently in today's proposal.

Item No. (OAR-2005-0083-xxxx)
    0044 ``Safety Indicators in Different Time Frames for the Safety 
Assessment of Underground Radioactive Waste Repositories,'' 
International Atomic Energy Agency
TECDOC-767, 1994
    0045 ``Regulatory Decision Making in the Presence of Uncertainty in 
the Context of Disposal of Long Lived Radioactive Wastes,'' 
International Atomic Energy Agency
TECDOC-975, 1997
    0046 ``The Handling of Timescales in Assessing Post-Closure Safety: 
Lessons Learnt from the April 2002 Workshop in Paris, France,'' Nuclear 
Energy Agency (Organisation for Economic Co-operation and Development), 
2004
    0051 ``Geological Disposal of Radioactive Waste,'' International 
Atomic Energy Agency Draft Safety Requirements (DS154), April 2005
    0061 ``Principles and Standards for Disposal of Long-Lived 
Radioactive Wastes,'' Neil Chapman and Charles McCombie, Elsevier 
Press, 2003
    0062 ``An International Peer Review of the Yucca Mountain Project 
TSPA-SR,'' Joint Report by the OECD Nuclear Energy Agency and the 
International Atomic Energy Agency, OECD, 2002
    0076 Technical Bases for Yucca Mountain Standards (the NAS Report), 
National Research Council, National Academy Press, 1995
    0077 ``Assessment of Variations in Radiation Exposure in the United 
States,'' EPA Technical Support Document, July 2005
    0085 ``Assumptions, Conservatisms, and Uncertainties in Yucca 
Mountain Performance Assessments,'' EPA Technical Support Document, 
July 2005
    0086 DOE Final Environmental Impact Statement, DOE/EIS-0250, 
February 2002

Acronyms and Abbreviations

    We use many acronyms and abbreviations in this document. These 
include:

BID--background information document
CED--committed effective dose
CEDE--committed effective dose equivalent
DOE--U.S. Department of Energy
DOE/VA--DOE's Viability Assessment
EIS--Environmental Impact Statement
EnPA--Energy Policy Act of 1992
EPA--U.S. Environmental Protection Agency
FEIS--Final Environmental Impact Statement
FEPs--features, events, and processes
FR--Federal Register
GCD--greater confinement disposal
HLW--high-level radioactive waste
HSK--Swiss Federal Nuclear Safety Inspectorate
IAEA--International Atomic Energy Agency

[[Page 49017]]

ICRP--International Commission on Radiological Protection
KASAM--Swedish National Council for Nuclear Waste
LLW--low-level radioactive waste
MCL--maximum contaminant level
MTHM--metric tons of heavy metal
NAPA--National Academy of Public Administration
NAS--National Academy of Sciences
NEA--Nuclear Energy Agency
NEI--Nuclear Energy Institute
NRC--U.S. Nuclear Regulatory Commission
NRDC--Natural Resources Defense Council
NTS--Nevada Test Site
NTTAA--National Technology Transfer and Advancement Act
NWPA--Nuclear Waste Policy Act of 1982
NWPAA--Nuclear Waste Policy Amendments Act of 1987
OECD--Organization for Economic Cooperation and Development
OMB--Office of Management and Budget
RMEI--reasonably maximally exposed individual
SSI--Swedish Radiation Protection Authority
SNF--spent nuclear fuel
SR--Site recommendation
TRU--transuranic
TSPA--Total System Performance Assessment
UK--United Kingdom
UMRA--Unfunded Mandates Reform Act of 1995
U.S.C.--United States Code
WIPP LWA--Waste Isolation Pilot Plant Land Withdrawal Act of 1992

Outline of Today's Action

I. What is the History of Today's Action?
    A. Promulgation of 40 CFR part 197 in 2001
    1. What are the Elements of EPA's 2001 Standards?
    a. What is the Standard for Storage of the Waste? (Subpart A, 
Sec. Sec.  197.1 through 197.5)
    b. What Are the Standards for Disposal? (Subpart B, Sec. Sec.  
197.11 through 197.36)
    i. What is the Standard for Protection of Individuals? 
(Sec. Sec.  197.20 through 197.21)
    aa. Who Represents the Exposed Population?
    bb. How Far Into the Future Must Performance be Assessed?
    ii. What is the Standard for Human Intrusion? (Sec. Sec.  197.25 
through 197.26)
    iii. What are the Standards to Protect Ground Water? (Sec. Sec.  
197.30 through 197.31)
    c. What is ``Reasonable Expectation''? (Sec.  197.14)
    B. Legal Challenges to 40 CFR part 197
    1. Challenges by the State of Nevada and Natural Resources 
Defense Council
    2. Challenge by the Nuclear Energy Institute
    C. Ruling by the U.S. Court of Appeals for the District of 
Columbia Circuit
    1. What Did the Court of Appeals Rule on the Issue of Compliance 
Period?
    a. What Were NAS's Findings (``Conclusions'') and 
Recommendations on the Issue of Compliance Period?
    2. What Did the Court of Appeals Rule on Other Issues Related to 
EPA's Standards?
II. How Will EPA Address the Decision by the Court of Appeals?
    A. How Will Elements of the Disposal Standards be Affected?
    1. Individual-Protection Standard
    2. Human-Intrusion Standard
    3. Ground-Water Protection Standards
    4. Reasonable Expectation
    5. Effects of Uncertainty
    B. How Does the Application of ``Reasonable Expectation'' 
Influence Today's Proposal?
    C. How Is EPA Proposing to Revise the Individual-Protection 
Standard (Sec.  197.20) to Address Peak Dose?
    1. Multiple Dose Standards Applicable to Different Compliance 
Periods
    2. What Other Options Did EPA Consider?
    a. Maintain the 10,000-year Standard Alone Without Addressing 
Peak Dose
    b. Dose Standard To Apply at Peak Dose Alone
    c. Peak Dose Standard Varying Over Time
    d. Standard Expressed as a Dose Target, Rather Than Limit
    e. Standard Expressed as a Statistical Distribution
    3. What Dose Level is EPA Proposing for Peak Dose?
    4. What Other Peak Dose Levels Did EPA Consider?
    a. Maintain the 15 mrem/yr Standard at Peak Dose
    b. 100 mrem/yr Standard at Peak Dose
    c. Peak Dose Standard Based on Regional Background Radiation 
Levels
    5. How Will NRC Judge Compliance?
    6. How Will DOE Calculate the Dose?
    D. How Will Today's Proposal Affect the Way DOE Conducts 
Performance Assessments?
    1. Performance Assessments Up To 10,000 Years After Disposal
    2. Performance Assessments for Periods Longer Than 10,000 Years 
After Disposal
    a. Consideration of Likely, Unlikely, and Very Unlikely FEPs
    b. Consideration of Seismic FEPs
    c. Consideration of Igneous (Volcanic) FEPs
    d. Consideration of Climatological FEPs
    E. How Is EPA Proposing To Revise the Human-Intrusion Standard 
(Sec.  197.25) To Address Peak Dose?
    F. Summary of Today's Proposal by Section
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health & Safety Risks
    H. Executive Order 13211: Actions that Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act

I. What Is the History of Today's Action?

    Radioactive wastes result from the use of nuclear fuel and other 
radioactive materials. Today, we are proposing to revise certain 
standards pertaining to spent nuclear fuel (SNF), high-level 
radioactive waste (HLW), and other radioactive waste (we refer to these 
items collectively as ``radioactive materials'' or ``waste'') that may 
be stored or disposed of in the Yucca Mountain repository. (When we 
discuss storage or disposal in this document in reference to Yucca 
Mountain, we note that no decision has been made regarding the 
acceptability of Yucca Mountain for storage or disposal as of the date 
of this publication. To save space and to avoid excessive repetition, 
we will not describe Yucca Mountain as a ``potential'' repository; 
however, we intend this meaning to apply.) Pursuant to Section 801(a) 
of the Energy Policy Act of 1992 (EnPA, Pub. L. 102-486), these 
standards apply only to facilities at Yucca Mountain.
    Once nuclear reactions have consumed a certain percentage of the 
uranium or other fissionable material in nuclear reactor fuel, the fuel 
no longer is useful for its intended purpose. It then is known as 
``spent'' nuclear fuel (SNF). It is possible to recover specific 
radionuclides from SNF through ``reprocessing,'' which is a process 
that dissolves the SNF, thus separating the radionuclides from one 
another. Radionuclides not recovered through reprocessing become part 
of the acidic liquid wastes that the Department of Energy (DOE) plans 
to convert into various types of solid materials. High-level waste 
(HLW) is the highly radioactive liquid or solid wastes that result from 
reprocessing SNF. The SNF that does not undergo reprocessing prior to 
disposal remains inside the fuel assembly and becomes the final waste 
form.
    In the U.S., SNF and HLW have been produced since the 1940s, mainly 
as a result of commercial power production and defense activities. 
Since the inception of the nuclear age, the proper disposal of these 
wastes has been the responsibility of the Federal government. The 
Nuclear Waste Policy Act of 1982 (NWPA, 42 U.S.C. Chapter 108) 
formalizes the current Federal

[[Page 49018]]

program for the disposal of SNF and HLW by:
    (1) Making DOE responsible for siting, building, and operating an 
underground geologic repository for the disposal of SNF and HLW;
    (2) Directing us to set generally applicable environmental 
radiation protection standards based on authority established under 
other laws \1\; and
---------------------------------------------------------------------------

    \1\ These laws include the Atomic Energy Act of 1954, as amended 
(42 U.S.C. 2011-2296) and Reorganization Plan No. 3 of 1970 (5 
U.S.C. Appendix 1).
---------------------------------------------------------------------------

    (3) Requiring the Nuclear Regulatory Commission (NRC) to implement 
our standards by revising its licensing requirements for SNF and HLW 
repositories to be consistent with our standards.
    This general division of responsibilities continues for the Yucca 
Mountain repository. Thus, today we are proposing to establish or 
revise specific aspects of our public health protection standards at 40 
CFR part 197 (which are, pursuant to EnPA Section 801(a), applicable 
only to Yucca Mountain, rather than generally applicable). The NRC will 
issue implementing regulations for these standards. The DOE plans to 
submit a license application to NRC. The NRC then will determine 
whether DOE has met NRC's regulations and whether to grant or deny a 
license for Yucca Mountain.
    In 1985, we established generic standards for the management, 
storage, and disposal of SNF, HLW, and transuranic (TRU) radioactive 
waste (see 40 CFR part 191, 50 FR 38066, September 19, 1985), which 
were intended to apply to any facilities utilized for the storage or 
disposal of these wastes, including Yucca Mountain. In 1987, the U.S. 
Court of Appeals for the First Circuit remanded the disposal standards 
in 40 CFR part 191 (NRDC v. EPA, 824 F.2d 1258 (1st Cir. 1987)). As 
discussed below, we later amended and reissued these standards to 
address issues that the court raised. Also in 1987, the Nuclear Waste 
Policy Amendments Act (NWPAA, Pub. L. 100-203) amended the NWPA by, 
among other actions, selecting Yucca Mountain, Nevada, as the only 
potential site that DOE should characterize for a long-term geologic 
repository. In October 1992, the Waste Isolation Pilot Plant Land 
Withdrawal Act (WIPP LWA, Pub. L. 102-579) and the EnPA became law. 
These statutes changed our obligations concerning radiation standards 
for the Yucca Mountain candidate repository. The WIPP LWA:
    (1) Reinstated the 40 CFR part 191 disposal standards, except those 
portions that were the specific subject of the remand by the First 
Circuit;
    (2) Required us to issue standards to replace the portion of the 
challenged standards remanded by the court; and
    (3) Exempted the Yucca Mountain site from the 40 CFR part 191 
disposal standards.

We issued the amended 40 CFR part 191 disposal standards, which 
addressed the judicial remand, on December 20, 1993 (58 FR 66398). The 
EnPA, enacted in 1992, set forth our responsibilities as they relate to 
Yucca Mountain. In the EnPA, Congress directed us to set public health 
and safety radiation standards for Yucca Mountain. Specifically, 
section 801(a)(1) of the EnPA directed us to ``promulgate, by rule, 
public health and safety standards for the protection of the public 
from releases from radioactive materials stored or disposed of in the 
repository at the Yucca Mountain site.'' Section 801(a)(2) directed us 
to contract with the National Academy of Sciences (NAS) to conduct a 
study to provide us with its findings and recommendations on reasonable 
standards for protection of public health and safety from releases from 
the Yucca Mountain disposal system. Moreover, it provided that our 
standards shall be the only such standards applicable to the Yucca 
Mountain site and are to be based upon and consistent with NAS's 
findings and recommendations. On August 1, 1995, NAS released its 
report, ``Technical Bases for Yucca Mountain Standards'' (the NAS 
Report) (Docket No. OAR-2005-0083-0076).

A. Promulgation of 40 CFR Part 197 in 2001

    Following the direction in the EnPA, we developed standards 
specifically applicable to releases from radioactive material stored or 
disposed of in the Yucca Mountain repository. In doing so, we gave 
special weight to both the NAS Report and our generic standards in 40 
CFR part 191, and also considered other relevant information, 
precedents, and analyses.
    We evaluated 40 CFR part 191 because those standards were developed 
to apply to any site selected for storage and disposal of SNF and HLW, 
and would have applied to Yucca Mountain had Congress not directed 
otherwise. Thus, we believed that 40 CFR part 191 already included the 
major components of standards needed for any specific site, such as 
Yucca Mountain. However, we recognized that all the components would 
not necessarily be directly transferable to the situation at Yucca 
Mountain, and that some modification might be necessary. We also 
considered that some components of the generic standards would not be 
carried into site-specific standards, simply because not all of the 
conditions found among all sites are present at each site. See 66 FR 
32076-32078, June 13, 2001 (Docket No. OAR-2005-0083-0042), for a more 
detailed discussion of the role of 40 CFR part 191 in developing 40 CFR 
part 197.
    We also considered the findings and recommendations of the NAS in 
developing standards for Yucca Mountain. In some cases, provisions of 
40 CFR part 191 were already consistent with NAS's analysis (e.g., 
level of protection for the individual). In other cases, we used the 
NAS Report to modify or draw out parts of 40 CFR part 191 to apply more 
directly to Yucca Mountain (e.g., the stylized drilling scenario for 
human intrusion). See the NAS Report for a complete description of 
findings and recommendations.
    Because our standards are intended to apply specifically to the 
Yucca Mountain disposal system, in a number of areas we tailored our 
approach to consider the characteristics of the site and the local 
populations. Yucca Mountain is in southwestern Nevada approximately 100 
miles northwest of Las Vegas. The eastern part of the site is on the 
Nevada Test Site (NTS). The northwestern part of the site is on the 
Nellis Air Force Range. The southwestern part of the site is on Bureau 
of Land Management land. The area has a desert climate with topography 
typical of the Basin and Range province. Yucca Mountain is made of 
layers of ashfalls from volcanic eruptions that happened more than 10 
million years ago. There are two major aquifers beneath Yucca Mountain. 
Regional ground water in the vicinity of Yucca Mountain is believed to 
flow generally in a south-southeasterly direction. The DOE plans to 
build the repository about 300 meters below the surface and about 300 
to 500 meters above the water table. For more detailed descriptions of 
Yucca Mountain's geologic and hydrologic characteristics, and the 
disposal system, please see chapter 7 of the 2001 BID (Docket No. OAR-
2005-0083-0050) and the preamble to the proposed rule (64 FR 46979-
46980, August 27, 1999, Docket No. OAR-2005-0083-0041).
    We proposed standards for Yucca Mountain on August 27, 1999 (64 FR 
46976). In response to our proposal, we received more than 800 public 
comments and conducted four public hearings. After evaluating public 
comments, we issued final standards (66 FR 32074, June 13, 2001). See 
the Response to Comments document from that rulemaking for more 
discussion of

[[Page 49019]]

comments (Docket No. OAR-2005-0083-0043).
1. What Are the Elements of EPA's 2001 Standards?
    We are issuing today's proposal to respond to a ruling by the U.S. 
Court of Appeals for the District of Columbia Circuit (``the Court'') 
that vacated portions of 40 CFR part 197. Sections I.B (``Legal 
Challenges to 40 CFR part 197'') and I.C (``Ruling by U.S. Court of 
Appeals for the District of Columbia Circuit'') discuss aspects of the 
legal challenges on which the Court ruled. This section summarizes some 
of the key provisions and concepts in 40 CFR part 197 to provide a 
context to better understand the basis for the legal actions and 
today's proposed action, which is described in Section II of this 
document (``How Will EPA Address the Decision by the Court of 
Appeals?'').
    The standards issued in 2001 as 40 CFR part 197 included the 
following:
     A standard to protect the public during storage operations 
at the Yucca Mountain site;
     An individual-protection standard to protect the public 
after disposal from releases from the undisturbed repository;
     A human-intrusion standard to protect the public after 
disposal from releases caused by a drilling penetration into the 
repository;
     A set of standards to protect ground water from 
radionuclide contamination caused by releases from the repository after 
disposal;
     The requirement that compliance with the disposal 
standards be shown for 10,000 years;
     The requirement that DOE continue its projections for the 
individual-protection and human-intrusion standards beyond 10,000 years 
to the time of peak (maximum) dose, and place those projections in the 
Environmental Impact Statement (EIS);
     The concept of the Reasonably Maximally Exposed Individual 
(RMEI), defined as a hypothetical person whose lifestyle is 
representative of the local population, as the individual against whom 
the disposal standards should be assessed; and
     The concept of a ``controlled area,'' defined as an area 
immediately surrounding the repository whose geology is considered part 
of the natural barrier component of the overall disposal system, and 
inside of which radioactive releases are not regulated.
    We emphasize that today's proposal is narrowly focused to respond 
to the Court ruling. Most sections of our 2001 rule are unaffected by 
the Court's ruling and are not implicated in today's proposal. We are 
requesting and will respond to comments only on those provisions we are 
proposing to change today.

a. What Is the Standard for Storage of the Waste? (Subpart A, 
Sec. Sec.  197.1 Through 197.5)

    Section 801(a)(1) of the EnPA calls for EPA's public health and 
safety standards to apply to radioactive materials ``stored or disposed 
of in the repository at the Yucca Mountain site.'' The repository is 
the excavated portion of the facility constructed underground within 
the Yucca Mountain site. The storage standard, therefore, applies to 
waste inside the repository, prior to disposal.
    The DOE also will handle, and might store, radioactive material 
outside the repository prior to subsurface emplacement. Therefore, our 
standards will provide public health and safety protection for surface 
management and storage activities on the surface of the Yucca Mountain 
site and in the Yucca Mountain repository. The combined doses incurred 
by any individual in the general environment from these activities must 
not exceed 150 [mu]Sv (15 mrem) committed effective dose equivalent per 
year (CEDE/yr).

b. What Are the Standards for Disposal? (Subpart B, Sec. Sec.  197.11 
Through 197.36)

    Subpart B of our 2001 rule consisted of three separate standards 
(or sets of standards) that apply after disposal, which are discussed 
in more detail in the appropriate sections of this document (e.g., 
Section II.A, ``How Will Elements of the Disposal Standards be 
Affected?''). For additional detail, see the preamble to the June 2001 
rulemaking (66 FR 32074, June 13, 2001). The disposal standards are:
     An individual-protection standard;
     A human-intrusion standard; and
     Ground-water protection standards.
i. What Is the Standard for Protection of Individuals? (Sec. Sec.  
197.20 Through 197.21)
    The first standard is an individual-protection standard. It 
specifies the maximum dose that a reasonably maximally exposed 
individual (RMEI) may receive from releases from the Yucca Mountain 
repository.
    Our individual-protection standard set a limit of 150 [mu]Sv (15 
mrem) CEDE/yr. This limit corresponds to an annual risk of fatal cancer 
within the range that NAS suggested as a ``reasonable starting point 
for EPA's rulemaking'' (NAS Report p. 5, Docket No. OAR-2005-0083-
0076). The NAS s suggested risk range corresponds to approximately 2 to 
20 mrem CEDE/yr.
    The standard described above applies for a period of 10,000 years 
after disposal, and is to be measured against exposures to the RMEI at 
a location outside the controlled area (in the ``accessible 
environment'').

aa. Who Represents the Exposed Population?

    To determine whether the Yucca Mountain disposal system complies 
with our standard, DOE must calculate the dose received by some 
individual or group of individuals exposed to releases from the 
repository and compare the calculated dose with the limit established 
in the standard. The standard specifies, therefore, the representative 
individual for whom DOE must make the dose calculation as the RMEI. It 
was left to NRC to define the details, beyond those which we specified, 
necessary for the dose calculation. NRC has further defined the RMEI as 
an adult (10 CFR 63.312(e)) and specified that the average 
concentration of radionuclides in well water ingested by the RMEI be 
based on a water demand of 3,000 acre-feet per year (10 CFR 63.312(c)).

The Reasonably Maximally Exposed Individual (RMEI)

    The approach we chose (the RMEI) embodies the intent of the 
internationally-accepted concept to protect those individuals most at 
risk from the proposed repository but specifies one or a few site-
specific parameters at their maximum values. The characteristics of the 
RMEI are defined from consideration of current population distribution 
and ground-water usage, and average food consumption patterns for the 
population downgradient from Yucca Mountain in Amargosa Valley, Nevada.
    Our RMEI is a theoretical individual representative of a future 
population group or community termed ``rural-residential'' (see Chapter 
8 of the 2001 BID for a description of this concept, Docket No. OAR-
2005-0083-0050). We assume that the rural-residential RMEI is exposed 
through the same general pathways as a subsistence farmer. However, 
this RMEI would not be a full-time farmer. Rather, the RMEI might do 
personal gardening and earn income from other sources of work in the 
area. Under our standard, the RMEI will have food and water intake 
rates, diet, and physiology similar to those of individuals living in 
Amargosa Valley, Nevada. We assume that all of the drinking water and 
some of the food (based upon surveys) consumed by the RMEI is from the 
local area. Similarly, we assume that local food production

[[Page 49020]]

will use water contaminated with radionuclides released from the 
disposal system. We believe this lifestyle is conservative but similar 
to that of most people living in Amargosa Valley today.
    Location of the RMEI. The location of the RMEI is a basic part of 
the exposure scenario. We require that the RMEI be located in the 
accessible environment (i.e., outside the controlled area) above the 
highest concentration of radionuclides in the plume of contamination. 
Based upon a review of available site-specific information (see Chapter 
8 of the 2001 BID, Docket No. OAR-2005-0083-0050), we identified the 
southern edge of the Nevada Test Site as the southernmost extent of the 
controlled area. The actual compliance point will be determined through 
the licensing process. (Even if the RMEI were to be located north of 
this line of latitude, the RMEI must still have the characteristics 
described in Sec.  197.21.) As discussed in Section I.B (``Legal 
Challenges to 40 CFR part 197'') and I.C (``Ruling by the U.S. Court of 
Appeals for the District of Columbia Circuit''), the location of the 
RMEI was a subject of the Court decision, was upheld, and is not a 
subject of today's proposal.

bb. How Far Into the Future Must Performance Be Assessed?

    In 2001, we established a compliance period of 10,000 years. Under 
the 2001 standards, the peak dose within 10,000 years after disposal 
would be required to comply with the individual-protection standard. In 
addition, we required calculation of the peak dose beyond 10,000 years, 
but within the period of geologic stability. We required DOE to include 
the results and bases of the additional analyses in the EIS for Yucca 
Mountain as an indicator of the future performance of the disposal 
system. The rule did not, however, require that DOE meet a specific 
dose limit after 10,000 years. The compliance period was a subject of 
the Court decision and is the primary subject of today's proposal.
ii. What Is the Standard for Human Intrusion? (Sec. Sec.  197.25 
Through 197.26)
    We adopted NAS's suggested starting point for a human-intrusion 
scenario. As NAS recommended, our standard required a single-borehole 
intrusion scenario based upon Yucca Mountain-specific conditions. The 
intended purpose of analyzing this scenario ``* * * is to examine the 
site- and design-related aspects of repository performance under an 
assumed intrusion scenario to inform a qualitative judgment'' (NAS 
Report p. 111). The assessment would result in a calculated RMEI dose 
arriving through the pathway created by the assumed borehole (with no 
other releases included). Consistent with the NAS Report, we also 
required ``that the conditional risk as a result of the assumed 
intrusion scenario should be no greater than the risk levels that would 
be acceptable for the undisturbed-repository case'' (NAS Report p. 
113). We interpreted NAS's term ``undisturbed'' to mean that the Yucca 
Mountain disposal system is not disturbed by human intrusion but that 
other processes or events that are likely to occur could disturb the 
system.
    The DOE is not required to use probabilistic performance assessment 
for the human-intrusion analysis, as it is for the individual-
protection standard. However, if it chooses to do so, we required that 
the human-intrusion analysis of disposal system performance use the 
same methods and RMEI characteristics for the performance assessment as 
those required for the individual-protection standard, with the 
exception that the human-intrusion analysis would exclude unlikely 
natural features, events, and processes (FEPs).
    The DOE must determine when the intrusion would occur based upon 
the earliest time that current technology and practices could lead to 
waste package penetration without the drillers noticing the canister 
penetration. In general, we believe that the time frame for the 
drilling intrusion should be within the period that a small percentage 
of the waste packages have failed but before significant migration of 
radionuclides from the engineered barrier system has occurred because, 
based upon our understanding of drilling practices, this period would 
be about the earliest time that a driller would not recognize an impact 
with a waste package.
    The compliance standard for human intrusion parallels that for the 
individual-protection scenario. If the intrusion were to occur at or 
earlier than 10,000 years after disposal, DOE must demonstrate a 
reasonable expectation that annual exposures incurred by the RMEI 
within 10,000 years as a result of the intrusion event would not exceed 
150 [mu]Sv (15 mrem) CEDE. However, if the intrusion occurred after 
10,000 years, or when earlier intrusions result in exposures projected 
to occur after 10,000 years, DOE would not have to compare its results 
against a numerical standard, but would have to include those results 
in its EIS.
iii. What Are the Standards To Protect Ground Water? (Sec. Sec.  197.30 
Through 197.31)
    We established separate ground-water standards as a means to 
protect the aquifer as both a resource for current users and a 
potential resource for larger numbers of future users either near the 
repository or farther away in communities comprised of a substantially 
larger number of people than presently exist in the vicinity of Yucca 
Mountain. The standards DOE must meet are equivalent to the 
radionuclide Maximum Contaminant Levels (MCLs) established for drinking 
water.
    To implement the ground-water protection standards in Sec.  197.30, 
we required that DOE use the concept of a ``representative volume'' of 
ground water (Sec.  197.31). Under this approach, DOE must project the 
concentration of radionuclides or the resultant doses within a 
``representative volume'' of ground water for comparison against the 
standards. We selected a value of 3,000 acre-ft/yr as a ``cautious, but 
reasonable'' figure for the representative volume. Section 197.31 also 
describes two methods by which DOE may calculate radionuclide 
concentrations in ground water. See the preamble to the 2001 rulemaking 
for more discussion of the representative volume and approaches for 
calculating radionuclide concentrations for compliance purposes.
    As with the individual-protection standard, compliance with the 
ground-water protection standards must be determined at the point of 
highest concentration in the plume of contamination in the accessible 
environment. The controlled area was defined in the same way as for the 
individual-protection standard. The ground-water protection standards 
were a subject of the Court decision, were upheld, and are not a 
subject of today's proposal.

c. What Is ``Reasonable Expectation''? (Sec.  197.14)

    An important provision of our standards is the establishment of the 
principle of ``reasonable expectation'' to guide implementation of our 
standards and provide context for evaluating projections against the 
numerical compliance standards discussed above. It is a critical 
element in implementing our standards, but its importance might easily 
be overlooked or misunderstood. We use the concept of ``reasonable 
expectation'' in these standards to reflect our intent regarding the 
level of ``proof'' necessary for NRC to determine whether the projected 
performance of

[[Page 49021]]

the Yucca Mountain disposal system complies with the standards (see 
Sec. Sec.  197.20, 197.25, and 197.30). In issuing our 2001 standards, 
we noted that this term is meant to convey our position that 
unequivocal numerical proof of compliance is neither necessary nor 
likely to be obtained for geologic disposal systems. We believe 
unequivocal proof is not possible because of the extremely long time 
periods involved and because disposal system performance assessments 
require extrapolations of conditions and the actions of processes that 
govern disposal system performance over those long time periods.
    The primary means for demonstrating compliance with the standards 
is the use of computer modeling to project the performance of the 
disposal system under the range of expected conditions. These modeling 
calculations involve the extrapolation of site conditions and the 
interactions of important processes over long time periods, 
extrapolations that involve inherent uncertainties in the necessarily 
limited amount of information that can be collected through field and 
laboratory studies and the unavoidable uncertainties involved in 
simulating the complex and time-variable processes and events involved 
in long-term disposal system performance. Overly conservative 
assumptions made in developing performance scenarios can bias the 
analyses in the direction of unrealistically extreme situations, which 
in reality may be highly improbable, and can deflect attention from 
questions critical to developing an adequate understanding of the 
expected features, events, and processes (``Assumptions, Conservatisms, 
and Uncertainties in Yucca Mountain Performance Assessments,'' Sections 
11 and 12, July 2005, Docket No. OAR-2005-0083-0085). The reasonable 
expectation approach focuses attention on understanding the 
uncertainties in projecting disposal system performance so that 
regulatory decision making will be done with a full understanding of 
the uncertainties involved. Thus, realistic analyses are preferred over 
conservative and bounding assumptions, to the extent practical.

B. Legal Challenges to 40 CFR Part 197

    Various aspects of our standards were challenged in lawsuits filed 
with the U.S. Court of Appeals for the District of Columbia Circuit in 
July 2001. Oral arguments were conducted on January 14, 2004. These 
challenges and the outcome are described in the following sections.
1. Challenges by the State of Nevada and Natural Resources Defense 
Council
    The State of Nevada, the Natural Resources Defense Council (NRDC), 
and several other environmental and public interest groups challenged 
several aspects of our final standards on the grounds that they were 
insufficiently protective and had not been adequately justified. 
Specifically, they claimed that:
     EPA's promulgation of standards that apply for 10,000 
years after disposal violates the EnPA because such standards are not 
``based upon and consistent with'' the findings and recommendations of 
the NAS. NAS recommended standards that would apply to the time of 
maximum risk and stated that there is ``no scientific basis for 
limiting the time period of the individual-risk standard to 10,000 
years or any other value.''
     The size of the controlled area defined by EPA, which 
represents the maximum extent of the disposal system and inside which 
DOE need not demonstrate compliance with the EPA standards, rests on 
inappropriate assumptions regarding the ability of people to live 
closer to the repository and violates the Safe Drinking Water Act 
provisions against endangering sources of drinking water.
     EPA's definition of ``disposal'' in 40 CFR 197.12 deviates 
from the definition in the NWPA by inserting the qualifying phrase 
``for as long as reasonably possible,'' suggesting that the Yucca 
Mountain disposal system would be held to a lesser standard of 
protection because it would not have to provide ``permanent 
isolation.''
2. Challenge by the Nuclear Energy Institute
    The Nuclear Energy Institute (NEI) is a trade organization 
representing nuclear power producers, who collect a surcharge from 
ratepayers for the Nuclear Waste Fund (established by the NWPA, see 42 
U.S.C. 10222). NEI challenged the ground-water protection provisions in 
40 CFR 197.30 on several grounds, including that:
     They conflict with the direction in the EnPA that EPA 
issue standards ``based upon and consistent with the findings and 
recommendations of'' NAS and that EPA's ``standards shall prescribe the 
maximum annual effective dose equivalent * * * from releases * * * from 
radioactive materials stored or disposed of in the repository.'' NEI 
argued that EPA's ground-water standards: (1) were in a form other than 
effective dose equivalent (EDE); (2) were not recommended by NAS, which 
stated that such standards were not ``necessary to limit risks to 
individuals'' (NAS Report p. 121); and (3) were not limited to releases 
from the repository because they require that DOE consider natural 
background when determining compliance.
     The science underlying the ground-water standards uses the 
outdated ``critical organ'' methodology, which results in inconsistent 
risk estimates and is inconsistent with other radiation-protection 
standards.
     EPA justified its ground-water standards on cost grounds 
without conducting a thorough cost-benefit analysis; NEI believes such 
an analysis would show that the ground-water standards provide no 
benefit to public health but will increase the cost and slow the 
construction of the repository.
     EPA is inappropriately applying drinking water standards, 
which were derived to apply to customers of public water supplies 
(i.e., ``at the tap'') to ground water.

C. Ruling by the U.S. Court of Appeals for the District of Columbia 
Circuit

    Oral arguments for the challenges described above were heard on 
January 14, 2004. The challenges to EPA's standards were consolidated 
with challenges to NRC's licensing requirements, DOE's siting 
guidelines, and the Presidential recommendation of the Yucca Mountain 
site and the subsequent Congressional resolution. The Court's ruling 
was handed down on July 9, 2004. The Court upheld EPA's Yucca Mountain 
rule in all respects, save for the regulatory compliance period.
1. What Did the Court of Appeals Rule on the Issue of Compliance 
Period?
    The Court upheld the challenge to EPA's 10,000-year compliance 
period, ruling that EPA's action was not ``based upon and consistent 
with'' the NAS Report, and that EPA had not sufficiently justified its 
decision to apply compliance standards only to the first 10,000 years 
after disposal on policy grounds. Nuclear Energy Institute v. 
Environmental Protection Agency, 373 F.3d 1 (D.C. Cir. 2004) (NEI) 
(Docket No. OAR-2005-0083-0080). On that point, the Court stated that:

    NAS's conclusion that EPA ``might choose to establish consistent 
policies'' is of little importance * * * And although our case law 
makes clear that a phrase like ``based upon and consistent with'' 
does not require EPA to hew rigidly to NAS's findings, EnPA Section 
801(a) cannot reasonably be read to allow a regulation wholly 
inconsistent with NAS recommendations. (NEI, 373 F.3d at 30.)

    Similarly, the Court rejected EPA's reasoning that the requirement 
of 40

[[Page 49022]]

CFR 197.35 that DOE project performance to the time of peak dose and 
place those projections in the Environmental Impact Statement (EIS) 
addressed the intent of the NAS recommendation by ensuring that 
assessments would not be arbitrarily cut off at some earlier time:

    Although EPA's addition of this provision might well represent a 
nod to NAS, it hardly makes the agency's regulation consistent with 
the Academy's findings. NAS recommended that the compliance period 
extend to the time of peak risk, yet EPA's rule requires only that 
DOE calculate peak doses and expressly provides that ``[n]o 
regulatory standard applies to the results of this analysis.'' (Id. 
at 31, emphasis in original)

    While the Court suggested that under different circumstances the 
Agency's standard might have been upheld, it nevertheless rejected the 
Agency's limitation of the compliance period to 10,000 years:

    In sum, because EPA's chosen compliance period sharply differs 
from NAS's findings and recommendations, it represents an 
unreasonable construction of section 801(a) of the Energy Policy 
Act. Although EnPA's ``based upon and consistent with'' mandate 
leaves EPA with some flexibility in crafting standards in light of 
NAS's findings, EPA may not stretch this flexibility to cover 
standards that are inconsistent with the NAS Report. Had EPA begun 
with the Academy's recommendation to base the compliance period on 
peak dosage and then made adjustments to accommodate policy 
considerations not considered by NAS, this might be a very different 
case. But as the foregoing discussion demonstrates, EPA wholly 
rejected the Academy's recommendations. We will thus vacate part 197 
to the extent that it requires DOE to show compliance for only 
10,000 years following disposal. (Id. at 31.)

    Finally, the Court concluded that ``we vacate 40 CFR part 197 to 
the extent that it incorporates a 10,000-year compliance period'' * * * 
(Id. at 100.) The Court did not address the protectiveness of the 150 
Sv/yr (15 mrem/yr) dose standard applied over the 10,000-year 
compliance period, nor was the protectiveness of the standard 
challenged. It ruled only that the compliance period could not be found 
consistent with or based upon the NAS findings and recommendations, and 
therefore was contrary to the plain language of the EnPA.

a. What Were NAS's Findings (``Conclusions'') and Recommendations on 
the Issue of Compliance Period?

    As the Court noted, NAS stated that it had found ``no scientific 
basis for limiting the time period of the individual-risk standard to 
10,000 years or any other value,'' and that ``compliance assessment is 
feasible * * * on the time scale of the long-term stability of the 
fundamental geologic regime--a time scale that is on the order of 10\6\ 
years at Yucca Mountain.'' As a result, and given that ``at least some 
potentially important exposures might not occur until after several 
hundred thousand years * * * we recommend that compliance assessment be 
conducted for the time when the greatest risk occurs'' (NAS Report pp. 
6-7).
    However, NAS also stated ``although the selection of a time period 
of applicability has scientific elements, it also has policy aspects 
that we have not addressed. For example, EPA might choose to establish 
consistent policies for managing risks from disposal of both long-lived 
hazardous nonradioactive materials and radioactive materials' (NAS 
Report p. 56).
2. What Did the Court of Appeals Rule on Other Issues Related to EPA's 
Standards?
    The Court did not sustain any of the other challenges lodged by 
Nevada, NRDC, or NEI. Instead, the Court found that:
     In defining the controlled area, EPA's conclusions 
regarding the likely extent of the future population and their 
exposures were reasonable. Further, the provisions of the Safe Drinking 
Water Act do not apply at Yucca Mountain (by virtue of the EnPA 
statement that EPA's standards ``shall be the only standards applicable 
to the Yucca Mountain site''). (NEI, 373 F. 3d at 32-38.)
     EPA is not bound to follow the NWPA definition of 
``disposal'' because the enabling authority for this action is the 
EnPA, which does not require that NWPA definitions be used and does not 
itself define ``disposal.'' Therefore, EPA acted reasonably ``in 
filling that statutory gap.'' (Id. at 38-39.)
     EPA's interpretation of the EnPA as permitting separate 
ground-water standards is reasonable because: (1) The EnPA does not 
restrict EPA to establish only EDE standards, but requires that EPA 
``establish a set of health and safety standards, at least one of which 
must include an EDE-based, individual-protection standard''; (2) NAS 
made no ``finding or recommendation'' either for or against a ground-
water standard, so consistency with NAS is not at issue; and (3) ``Part 
197 * * * does not regulate background radiation * * * the rule 
requires only that DOE take background levels into account when 
measuring permissible releases of radionuclides from the repository. 
Therefore, part 197 could not possibly run afoul of EnPA's focus on 
released radiation.'' (Id. at 43-48.)
     NEI's arbitrary and capricious arguments in NEI were the 
same as the arguments that NEI had raised in a challenge to EPA's 
radionuclide MCLs under the Safe Drinking Water Act, which the Court 
had rejected only one year previously in City of Waukesha v. EPA. (Id. 
at 48-49.)
     EPA ``unremarkably'' concluded that ground-water 
protection standards represent sound pollution prevention policy and 
will encourage a more robust repository design. This reasoning 
prevailed with the Court on both the cost-effectiveness and ``at the 
tap'' challenges. (Id. at 49-50.)

II. How Will EPA Address the Decision by the Court of Appeals?

    As promulgated, 40 CFR part 197 contai