Environmental Radiation Protection Standards for Yucca Mountain, Nevada

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Part II

Environmental Protection Agency

_______________________________________________________________________

40 CFR Part 197

Environmental Radiation Protection Standards for Yucca Mountain,

Nevada; Proposed Rule

Proposed Rules

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 197

[FRL-6427-5]

RIN 2060-AG14

Environmental Radiation Protection Standards for Yucca Mountain,

Nevada

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: We, the Environmental Protection Agency (EPA), are proposing

public health and safety standards for radioactive material stored or

disposed of in the potential repository at Yucca Mountain, Nevada.

Section 801 of the Energy Policy Act of 1992 (EnPA) directed the

Administrator of EPA to develop these standards. The EnPA also required

EPA 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. On August 1, 1995, NAS

released its report (the NAS Report) entitled, ``Technical Bases for

Yucca Mountain Standards.'' We have taken the NAS Report into

consideration as directed by the EnPA.

After we finalize these standards, the Nuclear Regulatory

Commission (NRC or ``the Commission'') will incorporate them into its

licensing regulations. The Department of Energy (DOE or ``the

Department'') will be responsible for demonstrating compliance with

these standards. The Commission will use its licensing regulations to

determine whether the Department has demonstrated compliance with our

standards prior to receiving the necessary licenses to store or dispose

of radioactive material in Yucca Mountain.

into its

licensing regulations. The Department of Energy (DOE or ``the

Department'') will be responsible for demonstrating compliance with

these standards. The Commission will use its licensing regulations to

determine whether the Department has demonstrated compliance with our

standards prior to receiving the necessary licenses to store or dispose

of radioactive material in Yucca Mountain.

DATES: Comments. We must receive your comments at the address given

below on or before November 26, 1999 to assure their consideration.

Hearings. We will hold public hearings upon today's action in

Amargosa Valley, Nevada, Las Vegas, Nevada, and Washington, DC. The

dates will be announced in the Federal Register as soon as they are

determined.

ADDRESSES: Comments. Send two copies of your comments to the Central

Docket Section (6102), ATTN: Docket A-95-12, U.S. Environmental

Protection Agency, 401 M Street, SW, Washington, D.C. 20460-0001.

Documents relevant to the rulemaking. Materials relevant to this

rulemaking are contained in: (1) Docket No. A-95-12, located in Room M-

1500 (first floor in Waterside Mall near the Washington Information

Center), U.S. Environmental Protection Agency, 401 M Street, SW,

Washington, DC 20460-0001; (2) an information file in the Government

Publications Section, Dickinson Library, University of Nevada-Las

Vegas, 4504 Maryland Parkway, Las Vegas, Nevada 89154; and (3) an

information file in the Public Library in Amargosa Valley, Nevada

89020.

Background documents for this action. We have prepared additional

documents that provide more detailed technical background in support of

these proposed standards. You may obtain copies of the draft background

information document (BID), the draft economic impact evaluation, and

the Executive Summary of the NAS Report by requesting them in writing

from the Office of Radiation and Indoor Air (6602J), U.S. Environmental

Protection Agency, Washington, DC 20460-0001

ents that provide more detailed technical background in support of

these proposed standards. You may obtain copies of the draft background

information document (BID), the draft economic impact evaluation, and

the Executive Summary of the NAS Report by requesting them in writing

from the Office of Radiation and Indoor Air (6602J), U.S. Environmental

Protection Agency, Washington, DC 20460-0001. We have also placed these

documents into the docket and information files. You may also find them

on our Internet site for Yucca Mountain (see the Additional Docket and

Electronic Information section later in this notice).

FOR FURTHER INFORMATION CONTACT: Ray Clark, Office of Radiation and

Indoor Air, U.S. Environmental Protection Agency, Washington, D.C.

20460-0001; telephone 202-564-9300.

SUPPLEMENTARY INFORMATION:

Who Will Be Regulated by These Standards?

The Department is the only entity directly regulated by these

standards. To utilize the Yucca Mountain repository, DOE must obtain

licensing approval from NRC. Thus, DOE will be subject to our standards

which NRC will implement through its licensing proceedings. The NRC is

only affected because, under the Energy Policy Act of 1992 (EnPA, Pub.

L. 102-486), it must modify its licensing requirements, as necessary,

to be consistent with our final standards.

Additional Docket and Electronic Information

When may I examine docket information? You may inspect the

Washington, D.C. docket (phone 202-260-7548) on weekdays (8 a.m.-5:30

p.m.). As provided in 40 CFR part 2, the docket personnel may charge a

reasonable fee for photocopying docket materials.

The information file located in the University of Nevada-Las Vegas,

Government Publications Section (702-895-3409) may be inspected when

classes are in session, Monday through Thursday (9 a.m.-8 p.m.), Friday

(9 a.m.-6 p.m.), Saturday (9 a.m.-9 p.m.), and Sunday (11 a.m.-8 p.m.).

However, since the hours vary based upon the academic calendar, you

should call ahead to be certain of the time

ov/radiation/yucca.

Acronyms

There are many acronyms used in this notice. They are listed below

for your reference and convenience.

ALARA--as low as reasonably achievable

BID--background information document

CAA--Clean Air Act

CEDE--committed effective dose equivalent

CG--critical group

DOE--U.S. Department of Energy

EIS--environmental impact statement

EnPA--Energy Policy Act of 1992

EPA--U.S. Environmental Protection Agency

GCD--greater confinement disposal

HLW--high-level radioactive waste

IAEA--International Atomic Energy Agency

ICRP--International Commission on Radiological Protection

LLW--low-level radioactive waste

MCL--maximum contaminant level

MCLG--maximum contaminant level goal

NAS--National Academy of Sciences

NCRP--National Council on Radiation Protection and Measurements

NEPA--National Environmental Policy Act

NESHAPs--National Emission Standards for Hazardous Air Pollutants

NID--negligible incremental dose

NIR--negligible incremental risk

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

OMB--Office of Management and Budget

RCRA--Resource Conservation and Recovery Act

RME--reasonable maximum exposure

RMEI--reasonably maximally exposed individual

SDWA--Safe Drinking Water Act

SNF--spent nuclear fuel

TDS--total dissolved solids

UIC--underground injection control

UMRA--Unfunded Mandates Reform Act of 1995

USDW--underground source of drinking water

WIPP LWA--Waste Isolation Pilot Plant Land Withdrawal Act of 1992

Outline of Proposed Action

rvation and Recovery Act

RME--reasonable maximum exposure

RMEI--reasonably maximally exposed individual

SDWA--Safe Drinking Water Act

SNF--spent nuclear fuel

TDS--total dissolved solids

UIC--underground injection control

UMRA--Unfunded Mandates Reform Act of 1995

USDW--underground source of drinking water

WIPP LWA--Waste Isolation Pilot Plant Land Withdrawal Act of 1992

Outline of Proposed Action

I. What Led up to Today's Action?

II. Background Information

II.A. What Are the Sources of Radioactive Waste?

II.B. What Types of Health Effects Can Radiation Cause?

II.C. What Are the Major Features of the Geology of Yucca

Mountain and the Disposal System?

II.D. Background on and Summary of the NAS Report

II.D.1. What Were the NAS Findings and Recommendations?

II.D.2. How Has the Public Participated in Our Review of the NAS

Report?

II.D.3. What Were the Public Comments on the NAS Report?

III. What Are We Proposing Today?

III.A. What Is the Proposed Standard for Storage of the Waste?

(Proposed Subpart A)

III.B. What Is the Standard for Protection of Individuals?

(Proposed Secs. 197.20 and 197.25)

III.B.1. Should the Limit Be on Dose or Risk?

III.B.2. What Should the Level of Protection Be?

III.B.3. What Factors Can Lead to Radiation Exposure?

III.B.4. Who Will Be Representative of the Exposed Population?

III.B.5. How Will the General Population Be Protected?

III.B.6. What Should Be Assumed About the Future Biosphere?

III.B.7. How Far Into the Future Is It Reasonable To Project

Disposal System Performance?

III.C. What Are the Requirements for Performance Assessments and

Determinations of Compliance? (Proposed Secs. 197.20, 197.25, and

197.35)

III.C.1. What Limits Are There on Factors Included in the

Performance Assessments?

III.C.2. Is Expert Opinion Allowed?

III.C.3. What Level of Expectation Is Required for NRC To

Determine Compliance?

III.D. Are There Qualitative Requirements To Help Assure

Protection?

III.E. What Is the Standard for Human Intrusion? (Proposed

Sec. 197.25)

III.F

(Proposed Secs. 197.20, 197.25, and

197.35)

III.C.1. What Limits Are There on Factors Included in the

Performance Assessments?

III.C.2. Is Expert Opinion Allowed?

III.C.3. What Level of Expectation Is Required for NRC To

Determine Compliance?

III.D. Are There Qualitative Requirements To Help Assure

Protection?

III.E. What Is the Standard for Human Intrusion? (Proposed

Sec. 197.25)

III.F. How Will Ground Water Be Protected? (Proposed

Sec. 197.35)

III.F.1. Is the Storage or Disposal of Radioactive Material in

the Yucca Mountain Repository Underground Injection?

III.F.2. Does the Class-IV Well Ban Apply?

III.F.3. Which Ground Water Should Be Protected?

III.F.4. How Far Into the Future Should Compliance Be Projected?

III.F.5. How Will the Point of Compliance Be Identified?

III.F.6. Where Will the Point of Compliance Be Located?

IV. Specific Questions for Public Comment

V. Regulatory Analyses

V.A. Executive Order 12866

V.B. Executive Order 12875

V.C. Executive Order 12898

V.D. Executive Order 13045

V.E. Executive Order 13084

V.F. National Technology Transfer and Advancement Act

V.G. Paperwork Reduction Act

V.H. Regulatory Flexibility Act/Small Business Regulatory

Enforcement Fairness Act of 1996

V.I. Unfunded Mandates Reform Act

I. What Led up to Today's Action?

Spent nuclear fuel (SNF) and high-level radioactive waste (HLW)

have been produced since the 1940s, mainly as a result of commercial

power production and defense activities. Since then, the proper

disposal of these wastes has been the responsibility of the Federal

government. The Nuclear Waste Policy Act of 1982 (NWPA, Pub. L. 97-425)

formalized the current Federal 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 upon authority established under

other laws; and

Policy Act of 1982 (NWPA, Pub. L. 97-425)

formalized the current Federal 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 upon authority established under

other laws; and

(3) Requiring NRC to implement our standards by incorporating them

into its licensing requirements for SNF and HLW repositories.

Those responsibilities are generally maintained under the EnPA.

Thus, NRC will implement the standards that we are proposing today, and

DOE will submit a license application to NRC. The Commission will then

determine whether DOE has met the standards and whether to issue an

operating license for Yucca Mountain. We anticipate that NRC will

require compliance with all of the applicable provisions of 40 CFR part

197 prior to allowing receipt of radioactive material onto the Yucca

Mountain site.

In 1985, we established generic standards for the management,

storage, and disposal of SNF, HLW, and transuranic radioactive waste.

These standards are found in 40 CFR part 191 (50 FR 38066, September

19, 1985). The term ``generic'' meant that the standards applied to any

applicable facilities in the United States, including Yucca Mountain,

Nevada. In 1987, the U.S. Court of Appeals for the First Circuit

invalidated the disposal standards and remanded them to us (NRDC v.

EPA, 824 F.2d 1258 (1st Cir. 1987)). 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 to be characterized.

In October 1992, the Waste Isolation Pilot Plant Land Withdrawal

Act (WIPP LWA, Pub. L. 102-579) and the EnPA became law. The statutes

changed our obligations concerning certain radiation standards. The

WIPP LWA:

lear 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 to be characterized.

In October 1992, the Waste Isolation Pilot Plant Land Withdrawal

Act (WIPP LWA, Pub. L. 102-579) and the EnPA became law. The statutes

changed our obligations concerning certain radiation standards. The

WIPP LWA:

(1) Reinstated the 40 CFR part 191 disposal standards except those

that were the specific subject of the remand by the First Circuit;

(2) Required us to issue standards to replace those that were the

subject of judicial remand; and

(3) Exempted the Yucca Mountain site from the 40 CFR part 191

disposal standards. We issued the final disposal standards in 40 CFR

part 191 on December 20, 1993 (58 FR 66398) to address the judicial

remand.

The EnPA gave us the responsibility 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.'' The EnPA also directed us to contract with NAS

to give us findings and recommendations on reasonable standards for

protection of public health and safety. Moreover, the statute 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'

findings and recommendations. On August 1, 1995, NAS released its

report, ``Technical Bases for Yucca Mountain Standards'' (the NAS

Report).

II. Background Information

II.A. What Are the Sources of Radioactive Waste?

fety. Moreover, the statute 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'

findings and recommendations. On August 1, 1995, NAS released its

report, ``Technical Bases for Yucca Mountain Standards'' (the NAS

Report).

II. Background Information

II.A. What Are the Sources of Radioactive Waste?

Radioactive wastes are the result of using nuclear fuel and other

radioactive material. Today's action proposes standards pertaining to

SNF, HLW, and other radioactive waste (these are collectively referred

to after this as ``radioactive material'' or ``waste'') which may be

stored or disposed of in the Yucca Mountain repository. (When storage

or disposal are discussed in this notice in reference to Yucca

Mountain, it is to be understood that no decision has been made

regarding the acceptability of Yucca Mountain for storage or disposal.

To save space and excessive repetition, the description of Yucca

Mountain as a ``potential'' repository will not be used but is

intended.) These standards do not apply to facilities other than those

related to Yucca Mountain.

Once enough uranium or other fissionable material in nuclear

reactor fuel has been consumed through nuclear reactions, it is no

longer useful. The product is known as ``spent'' nuclear fuel (SNF).

Sources of SNF include:

(1) Commercial nuclear power plants;

(2) Government-sponsored research and development programs in

universities and industry;

(3) Experimental reactors, such as, liquid metal fast breeder

reactors and high-temperature gas-cooled reactors;

(4) Federal Government-controlled, nuclear-weapons production

reactors;

(5) Naval and other Department of Defense reactors; and

Sources of SNF include:

(1) Commercial nuclear power plants;

(2) Government-sponsored research and development programs in

universities and industry;

(3) Experimental reactors, such as, liquid metal fast breeder

reactors and high-temperature gas-cooled reactors;

(4) Federal Government-controlled, nuclear-weapons production

reactors;

(5) Naval and other Department of Defense reactors; and

(6) U.S.-owned, foreign SNF.

Spent nuclear fuel can be dissolved in a chemical process called

``reprocessing,'' which is used to recover desired radionuclides.

Radionuclides which are not recovered become part of the acidic liquid

wastes that DOE plans to convert into various types of solid materials.

The highly radioactive liquid or solid wastes from reprocessing SNF are

called HLW. If SNF is not reprocessed prior to disposal, it becomes the

waste form without further modification. The only commercial

reprocessing facility to operate in the United States, the Nuclear Fuel

Services Plant in West Valley, New York, closed in 1972. Since that

time, no commercial SNF has been reprocessed in the United States. In

1992, DOE decided to phase out reprocessing of its SNF which supported

the defense nuclear weapons and propulsion programs.

Where are the wastes stored now? Today, most SNF is stored in water

pools or above-ground in dry concrete or steel canisters at more than

70 commercial nuclear-power reactor sites across the Nation. High-level

waste is stored underground in steel tanks at four Federal facilities

in Idaho, Washington, South Carolina, and New York.

What types of wastes will be placed into Yucca Mountain? We

anticipate that most of the waste in Yucca Mountain will be SNF and

solidified HLW (in the rest of this notice, HLW will refer to

solidified HLW unless otherwise noted)

reactor sites across the Nation. High-level

waste is stored underground in steel tanks at four Federal facilities

in Idaho, Washington, South Carolina, and New York.

What types of wastes will be placed into Yucca Mountain? We

anticipate that most of the waste in Yucca Mountain will be SNF and

solidified HLW (in the rest of this notice, HLW will refer to

solidified HLW unless otherwise noted). Under current NRC regulations

(10 CFR 60.135), liquid HLW will have to be solidified, through

processes such as vitrification (mixing the waste into glass), since

non-solid waste forms would not be allowed to be stored or disposed of

in Yucca Mountain. The Department estimates that by the year 2010,

about 64,000 metric tons of SNF and 284,000 cubic meters (containing

450 million curies of radioactivity) of HLW in predisposal form and

2,600 cubic meters (containing 189 million curies) of the disposable

form of HLW will be in storage (DOE/RW-0006, Rev. 12, December 1996).

We are aware that other radioactive materials might be stored or

disposed of in the Yucca Mountain repository. These materials include

highly radioactive low-level waste (LLW), known as greater-than-Class-C

waste, and excess plutonium or other fissile materials resulting from

the dismantlement of nuclear weapons. In the future, other types of

radioactive materials could be identified for storage or disposal.

Since the plans for the disposal of these materials have not been

finalized, their impact upon the design and performance of the disposal

system has not been analyzed by NRC or DOE. However, whatever types of

radioactive materials are finally disposed of in Yucca Mountain, the

disposal system must comply with these standards.

II.B. What Types of Health Effects Can Radiation Cause?

disposal.

Since the plans for the disposal of these materials have not been

finalized, their impact upon the design and performance of the disposal

system has not been analyzed by NRC or DOE. However, whatever types of

radioactive materials are finally disposed of in Yucca Mountain, the

disposal system must comply with these standards.

II.B. What Types of Health Effects Can Radiation Cause?

Ionizing radiation can cause a variety of health effects. These

effects are classified as either ``non-stochastic'' or ``stochastic.''

Non-stochastic effects are those for which the damage increases with

increasing exposure, such as destruction of cells or reddening of the

skin. They are seen in cases of exposures to large amounts of

radiation. Stochastic effects are associated with long-term exposure to

low levels of radiation. Their type or severity does not depend upon

the amount of exposure. Instead, the chance that an effect, for

example, cancer, will occur is assumed to increase with increasing

exposure.

The three categories of stochastic effects are cancer, mutations,

and teratogenic effects. Cancers caused by radiation are

indistinguishable from those occurring from other causes. Cancers

caused by radiation have been observed in humans. However, the risk of

cancer at the exposure levels normally encountered by members of the

public must be estimated using indirect evidence, that is,

extrapolation from higher doses.1

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\1\ The general term ``dose'' is used to mean the dose

equivalent, effective dose equivalent, or committed effective dose

equivalent, depending upon the surrounding text. When precision is

necessary, the exact term is used.

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from higher doses.1

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\1\ The general term ``dose'' is used to mean the dose

equivalent, effective dose equivalent, or committed effective dose

equivalent, depending upon the surrounding text. When precision is

necessary, the exact term is used.

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Mutations, the second category of stochastic effects, are created

in the reproductive cells of exposed individuals and are transmitted to

their descendants. The severity of hereditary effects can range from

inconsequential to fatal. Although hereditary effects have been

observed in animal studies at relatively high doses, hereditary effects

in humans exposed to relatively small amounts of radiation have not

been confirmed statistically in epidemiological studies. Finally, we

assume that at low levels of exposure, the probability of incurring

either cancer or hereditary effects increases as the dose increases and

that there is no lower threshold, that is, a linear, non-threshold,

dose-response relationship (this is discussed below in more detail).

Teratogenic effects, the third category of stochastic effects, can

occur following exposure of fetuses. We believe that the fetus is more

sensitive than adults to the induction of cancer by radiation. The

fetus also is subject to various radiation-induced, physical

malformations such as small brain size (microencephaly), small head

size (microcephaly), eye malformations and slow growth prior to birth.

Recent studies have focused upon the apparently increased risk of

severe mental retardation as measured by the intelligence quotient

itive than adults to the induction of cancer by radiation. The

fetus also is subject to various radiation-induced, physical

malformations such as small brain size (microencephaly), small head

size (microcephaly), eye malformations and slow growth prior to birth.

Recent studies have focused upon the apparently increased risk of

severe mental retardation as measured by the intelligence quotient.

These studies indicate that the sensitivity of the fetus is greatest

during 8 to 15 weeks following conception, and continues, at a lower

level, between 16 and 25 weeks.2 Although we do not know

exactly how mental retardation is related to dose, it is prudent to

assume that there is a linear, non-threshold, dose-response

relationship between these effects and the dose delivered to the fetus

during the 8- to 15-week period.

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\2\ Health Effects of Exposure to Low Levels of Ionizing

Radiation, National Academy Press, Washington, D.C., 1990.

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The NAS published its reviews of human health risks from exposure

to low levels of ionizing radiation in a

series of reports between 1972 and 1990. However, scientists still do

not agree upon how best to estimate the probability of cancer occurring

as a result of the doses encountered by members of the public

3 because these effects must be estimated based upon the

effects observed at higher doses (such as effects seen in the survivors

of the Hiroshima and Nagasaki atomic bombs). The linear model for

estimating effects has been endorsed by many organizations, including

NAS, the International Commission on Radiological Protection (ICRP),

the United Nations Scientific Committee on the Effects of Atomic

Radiation, and the National Radiological Protection Board of the United

Kingdom.

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tomic bombs). The linear model for

estimating effects has been endorsed by many organizations, including

NAS, the International Commission on Radiological Protection (ICRP),

the United Nations Scientific Committee on the Effects of Atomic

Radiation, and the National Radiological Protection Board of the United

Kingdom.

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\3\ The risk of interest is not at or near zero dose, but that

due to small increments of dose above the pre-existing background

level. Background in the U.S. is typically about 3 millisievert

(mSv), that is, 300 millirem (mrem), effective dose equivalent per

year, or 0.2 Sv (20 rem) in a lifetime. Approximately two-thirds of

this dose is due to radon, and the balance comes from cosmic,

terrestrial, and internal sources of exposure.

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Over the past decade, the scientific community has performed an

extensive reevaluation of the doses and effects in the Hiroshima and

Nagasaki survivors. These studies have resulted in increased estimates

(roughly threefold between 1972 and 1990) of the extrapolated risk of

cancer arising from exposure to environmental levels of radiation, that

is, background levels of radiation. Nonetheless, the estimated number

of health effects induced by small incremental doses of radiation above

natural background levels remains small compared with the total number

of fatal cancers that occur from other causes. In addition, because

cancers are the same as those resulting from other causes, identifying

them in human epidemiological studies may never be possible. This

difficulty in identifying stochastic radiation effects does not mean

that such effects do not occur. However, there is the possibility that

effects do not occur as a result of these small doses, that is, there

might be an exposure level below which there is no additional risk

above the risk that is posed by natural background radiation

human epidemiological studies may never be possible. This

difficulty in identifying stochastic radiation effects does not mean

that such effects do not occur. However, there is the possibility that

effects do not occur as a result of these small doses, that is, there

might be an exposure level below which there is no additional risk

above the risk that is posed by natural background radiation.

Sufficient data to prove either possibility scientifically is lacking.

As a result, we believe that the best approach is to assume that the

risk of cancer increases linearly starting at zero dose. That is, any

increase in exposure to ionizing radiation results in a constant and

proportionate increase in the potential for developing cancer.

The NAS Report stated that radiation causes about five cancers for

every severe hereditary disorder. Also, NAS concluded that nonfatal

cancers are more common than fatal cancers. Despite this, the NAS cited

an ICRP study which judged that non-fatal cancers contribute less to

overall health impact than fatal cancers ``because of their lesser

severity in the affected individuals.'' (NAS Report pp. 37-39). Our

risk estimates for exposure of the population to low-dose-rate

radiation is based upon fatal cancers rather than all cancers.

For radiation-protection purposes, we estimate (using a linear,

non-threshold, dose-response model) an average risk for a member of the

U.S. population of 5.75 in 100 (5.75 x 10-2) fatal cancers

per sievert (Sv) 4 (5.75 x 10-4 fatal cancers

per rem) delivered at low dose rates.5 (For example, if

100,000 people randomly chosen from the U.S. population were each given

a uniform dose of 1 millisievert (mSv) (0.1 rem) to the entire body at

a low rate, approximately five to six people are assumed to die of

cancer during their remaining lifetimes because of that exposure

-2) fatal cancers

per sievert (Sv) 4 (5.75 x 10-4 fatal cancers

per rem) delivered at low dose rates.5 (For example, if

100,000 people randomly chosen from the U.S. population were each given

a uniform dose of 1 millisievert (mSv) (0.1 rem) to the entire body at

a low rate, approximately five to six people are assumed to die of

cancer during their remaining lifetimes because of that exposure. This

is in addition to the roughly 20,000 fatal cancers that would occur in

the same population from other causes.) The risk of fatal childhood

cancer, resulting from exposure while in the fetal stage, is about 3 in

100 (3 x 10-2) per Sv (that is, 3 x 10-4

effects per rem). The risk of severe hereditary effects in offspring is

estimated to be about 1 x 10-2 per Sv (1 x

10-4 effects per rem).6 The risk of severe mental

retardation from doses to a fetus is estimated to be greater per unit

dose than the risk of cancer in the general population.7

However, the period of increased sensitivity is much shorter. Hence, at

a constant exposure rate, fatal cancer risk in the general population

remains the dominant factor.

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\4\ The traditional unit for dose equivalent has been the rem.

The unit ``sievert'' (Sv), a unit in the International System of

Units which was adopted in 1979 by the General Conference on Weights

and Measures, is now in general use throughout the world. One

sievert is equal to 100 rem. The prefix ``milli'' (m) means one-

thousandth. The individual-protection limit being proposed today may

be expressed in either unit.

\5\ ``Low dose rates'' here refer to dose rates on the order of

or less than those from background radiation.

\6\ The risk of severe hereditary effects in the first two

generations, for exposure of the reproductive part of the population

(with both parents exposed), is estimated to be 5 x

10-3 per Sv (5 x 10-5 per rem)

l-protection limit being proposed today may

be expressed in either unit.

\5\ ``Low dose rates'' here refer to dose rates on the order of

or less than those from background radiation.

\6\ The risk of severe hereditary effects in the first two

generations, for exposure of the reproductive part of the population

(with both parents exposed), is estimated to be 5 x

10-3 per Sv (5 x 10-5 per rem). For all

generations, the risk is estimated to be 1.2 x 10-2 per

Sv (1.2 x 10-4 per rem). For exposure of the entire

population, which includes individuals past the age of normal child-

bearing, each estimate is reduced to 40% of the cited value.

\7\ Assuming a linear, non-threshold dose response, estimated

risk for mental retardation due to exposure during the 8th through

15th week of gestation is 4 x 10-1 per Sv (4 x

10-3 per rem); under the same assumption, the estimated

risk from the 16th to 25th week is 1 x 10-1 per Sv (1

x 10-3 per rem).

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

We note that there is, of course, uncertainty in our risk

estimates. A recent uncertainty analysis published by the National

Council on Radiation Protection and Measurements (NCRP Report 126)

estimated that the actual risk of cancer from whole-body exposure to

low doses of radiation could be between 1.5 times higher and 4.8 times

lower (at the 90-percent confidence level) than our basic estimate of

5.75 x 10-2 per Sv (5.75 x 10-4 per rem).

Further, existing epidemiological data does not rule out the existence

of a threshold. If there is a threshold, exposures below that level

would pose no additional risk above the risk that is posed by natural

background radiation. The risks of genetic abnormalities and mental

retardation are less well known than those for cancer and, thus, may

include a greater degree of uncertainty

er rem).

Further, existing epidemiological data does not rule out the existence

of a threshold. If there is a threshold, exposures below that level

would pose no additional risk above the risk that is posed by natural

background radiation. The risks of genetic abnormalities and mental

retardation are less well known than those for cancer and, thus, may

include a greater degree of uncertainty. However, in spite of

uncertainties in the data and its analysis, estimates of the risks from

exposure to low levels of ionizing radiation are more clearly known

than those for virtually any other environmental carcinogen.

II.C. What Are the Major Features of the Geology of Yucca Mountain and

the Disposal System?

The geology. The Yucca Mountain site is located in southwestern

Nevada approximately 90 miles northwest of Las Vegas. The eastern part

of the site is on the Nevada Test Site, the northwestern part of the

site is on the Nellis Air Force Range, and 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. See

the BID for more information.

Yucca Mountain is made of layers of ashfalls from volcanic

eruptions which happened more than 10 million years ago. The ash

consolidated into a rock type called ``tuff'' which has varying degrees

of compaction and fracturing depending upon the degree of ``welding''

caused by temperature and pressure when the ash was deposited. Regional

geologic forces have tilted the tuff layers and formed Yucca Mountain's

crest (Yucca Mountain's shape is actually a ridge rather than a peak).

Below the tuff is carbonate rock. The carbonate rock was formed from

sediments laid down at the bottom of ancient seas which existed in the

area.

There are two general hydrologic zones within and below Yucca

Mountain. The upper zone is called the ``unsaturated zone'' because the

pore

ff layers and formed Yucca Mountain's

crest (Yucca Mountain's shape is actually a ridge rather than a peak).

Below the tuff is carbonate rock. The carbonate rock was formed from

sediments laid down at the bottom of ancient seas which existed in the

area.

There are two general hydrologic zones within and below Yucca

Mountain. The upper zone is called the ``unsaturated zone'' because the

pore

spaces and fractures within the rock are not filled entirely with

water. Below the unsaturated zone, beginning at the water table, is the

``saturated zone'' in which the pores and fractures are filled

completely with water. Fractures in both zones could act as pathways

which allow for faster contaminant transport than would the pores. The

Department plans to build the repository in the unsaturated zone about

300 meters below the surface and about 300 to 500 meters above the

current water table.

There are two major aquifers in the saturated zone under Yucca

Mountain. The upper one is in tuff, while the lower one is in carbonate

rock. Regional ground water in the vicinity of Yucca Mountain is

believed to flow generally in a south-southwesterly direction. The

aquifers are more fully discussed in the BID.

The disposal system. The NAS Report described the current

conception of the potential disposal system as a system of engineered

barriers for the disposal of radioactive waste located in the geologic

setting of Yucca Mountain (NAS Report pp. 23-27). Entry into the

repository for waste emplacement would be on gradually downward sloping

ramps which enter the side of Yucca Mountain. The NWPAA limits the

capacity of the repository to 70,000 metric tons of SNF and HLW.

Current DOE plans project that about 90 percent (by mass) would be

commercial SNF and 10 percent defense HLW. Within 100 years after

starting to put waste in place, the repository would be sealed by

backfilling the tunnels, closing the opening to each of the tunnels,

and sealing the entrance ramps and shafts

he NWPAA limits the

capacity of the repository to 70,000 metric tons of SNF and HLW.

Current DOE plans project that about 90 percent (by mass) would be

commercial SNF and 10 percent defense HLW. Within 100 years after

starting to put waste in place, the repository would be sealed by

backfilling the tunnels, closing the opening to each of the tunnels,

and sealing the entrance ramps and shafts.

We expect the engineered barrier system to consist of at least the

waste form (that is, SNF assemblies or borosilicate glass containing

the HLW), internal stabilizers for the SNF assemblies, the waste

packages holding the waste, and backfill in the space between the waste

packages and adjacent host rock. Spent nuclear fuel assemblies are

comprised of uranium oxide, fission products, fuel cladding, and

support hardware, all of which will be radioactive. (see the What are

the Sources of Radioactive Waste? section above.)

II.D. Background on and Summary of the NAS Report

Section 801(a)(2) of the EnPA directed us to contract with NAS to

conduct a study to provide findings and recommendations on reasonable

standards for protection of public health and safety. Section 801(a)(2)

of the EnPA specifically called for NAS to address the following three

issues:

(A) whether a health-based standard based upon doses to individual

members of the public from releases to the accessible environment (as

that term is defined in the regulations contained in subpart B of part

191 of title 40, Code of Federal Regulations, as in effect on November

18, 1985) will provide a reasonable standard for protection of the

health and safety of the general public;

(B) whether it is reasonable to assume that a system for post-

closure oversight of the repository can be developed, based upon active

institutional controls, that will prevent an unreasonable risk of

breaching the repository's engineered or geologic barriers or

increasing the exposure of individual members of the public to

radiation beyond allowable limits; and

(C) w

of the general public;

(B) whether it is reasonable to assume that a system for post-

closure oversight of the repository can be developed, based upon active

institutional controls, that will prevent an unreasonable risk of

breaching the repository's engineered or geologic barriers or

increasing the exposure of individual members of the public to

radiation beyond allowable limits; and

(C) whether it is possible to make scientifically supportable

predictions of the probability that the repository's engineered or

geologic barriers will be breached as a result of human intrusion over

a period of 10,000 years.

On August 1, 1995, NAS submitted to us its report entitled

``Technical Bases for Yucca Mountain Standards.'' The NAS Report is

available for review in the dockets and information file described

earlier. You can order the Report from the National Academy Press by

calling 800-624-6242 or on the World Wide Web at http://www.nap.edu/

bookstore/isbn/0309052890.html#title.

II.D.1. What Were the NAS Findings and Recommendations?

The NAS Report provided a number of conclusions and

recommendations. (The EnPA used the term ``findings,'' however, the NAS

Report used the term ``conclusions.'')

Conclusions. The conclusions in the Executive Summary of the NAS

Report (pp. 1-14) were:

(a) ``that an individual-risk standard would protect public health,

given the particular characteristics of the site, provided that policy

makers and the public are prepared to accept that very low radiation

doses pose a negligibly small risk'' [later termed ``negligible

incremental risk'']. This is the response to the issue identified in

section 801(a)(2)(A) of the EnPA;

(b) that the Yucca Mountain-related ``physical and geologic

processes are sufficiently quantifiable and the related uncertainties

sufficiently boundable that the performance can be assessed over time

frames during which the geologic system is relatively stable or varies

in a boundable manner;''

emental risk'']. This is the response to the issue identified in

section 801(a)(2)(A) of the EnPA;

(b) that the Yucca Mountain-related ``physical and geologic

processes are sufficiently quantifiable and the related uncertainties

sufficiently boundable that the performance can be assessed over time

frames during which the geologic system is relatively stable or varies

in a boundable manner;''

(c) ``that it is not possible to predict on the basis of scientific

analyses the societal factors required for an exposure scenario.

Specifying exposure scenarios therefore requires a policy decision that

is appropriately made in a rulemaking process conducted by EPA;''

(d) ``that it is not reasonable to assume that a system for post-

closure oversight of the repository can be developed, based on active

institutional controls, that will prevent an unreasonable risk of

breaching the repository's engineered barriers or increasing the

exposure of individual members of the public to radiation beyond

allowable limits.'' This is the response to the issue identified in

section 801(a)(2)(B) of the EnPA;

(e) ``that it is not possible to make scientifically supportable

predictions of the probability that a repository's engineered or

geologic barriers will be breached as a result of human intrusion over

a period of 10,000 years.'' This is the response to the issue

identified in section 801(a)(2)(C) of the EnPA; and

(f) ``that there is no scientific basis for incorporating the ALARA

[as low as reasonably achievable] principle into the EPA standard or

USNRC [U.S. Nuclear Regulatory Commission] regulations for the

repository.''

Recommendations. The recommendations in the Executive Summary of

the NAS Report were:

(a) ``the use of a standard that sets a limit on the risk to

individuals of adverse health effects from releases from the

repository;''

(b) ``that the critical-group approach be used'' (see the Who Will

Be Representative of the Exposed Population? section later in this

notice);

ions for the

repository.''

Recommendations. The recommendations in the Executive Summary of

the NAS Report were:

(a) ``the use of a standard that sets a limit on the risk to

individuals of adverse health effects from releases from the

repository;''

(b) ``that the critical-group approach be used'' (see the Who Will

Be Representative of the Exposed Population? section later in this

notice);

(c) ``that compliance assessment be conducted for the time when the

greatest risk occurs, within the limits imposed by long-term stability

of the geologic environment;'' and,

(d) ``that the estimated risk calculated from the assumed intrusion

scenario be no greater than the risk limit adopted for the undisturbed-

repository case because a repository that is suitable for safe long-

term disposal should be able to continue to provide acceptable waste

isolation after some type of intrusion.''

Other Conclusions and Recommendations. There were other conclusions

and recommendations in addition to those summarized in the Executive

Summary. Most were related to or supported those presented in the

Executive Summary.

II.D.2. How Has the Public Participated in Our Review of the NAS

Report?

We are committed to providing ample opportunity for public

participation in our Yucca Mountain rulemaking activities. We announced

the first opportunity for public participation on September 11, 1995 in

the Federal

Register (60 FR 47172) where we requested comments upon the NAS Report

and announced the times and locations of three public meetings. Along

with the general request for public comments, we asked five questions:

(1) did the Report sufficiently answer the questions posed in the

EnPA;

(2) was there sufficient rationale to support the NAS' findings and

conclusions;

(3) do provisions other than those found in NAS' findings and

conclusions need to be included in the EPA standards;

(4) are any of NAS' findings or conclusions inappropriate or

inaccurate regarding Yucca Mountain; and

asked five questions:

(1) did the Report sufficiently answer the questions posed in the

EnPA;

(2) was there sufficient rationale to support the NAS' findings and

conclusions;

(3) do provisions other than those found in NAS' findings and

conclusions need to be included in the EPA standards;

(4) are any of NAS' findings or conclusions inappropriate or

inaccurate regarding Yucca Mountain; and

(5) would the cost of imposing the findings and recommendations be

justifiable when compared with the benefits provided?

We held the public meetings to inform the public of our role, to

outline the issues associated with setting standards for Yucca

Mountain, and to seek comments upon the NAS Report. The meetings were

held on September 20, 1995, in Amargosa Valley, Nevada; on September

21, 1995, in Las Vegas, Nevada; and on September 27, 1995, in

Washington, DC. We also have established several other information

sources and given directions, in the ADDRESSES and Additional Docket

and Electronic Information sections earlier in this notice, on how to

access them.

II.D.3. What Were the Public Comments on the NAS Report?

We received comments regarding the NAS Report both orally and in

writing at the public meetings and in response to the September 11,

1995, Federal Register notice, respectively. All written comments are

in the docket and information files. The oral comments were summarized

in a separate document, copies of which are also in the docket and

information files.

Some commenters believed that the NAS inadequately supported its

conclusion that there is no scientific basis for including the ``as low

as reasonably achievable'' (ALARA) principle and subsystem requirements

in the standards and, therefore, that we should include them in the

proposed standards. The ALARA principle is a radiation-protection

concept which states that exposures to radiation should be kept as low

as can be done taking into account the costs and benefits of exposure

reduction methods

is for including the ``as low

as reasonably achievable'' (ALARA) principle and subsystem requirements

in the standards and, therefore, that we should include them in the

proposed standards. The ALARA principle is a radiation-protection

concept which states that exposures to radiation should be kept as low

as can be done taking into account the costs and benefits of exposure

reduction methods. ``Subsystem requirements'' refers to regulation of

individual components of the overall disposal system. Other comments

indicated that there was inadequate rationale to support NAS' concept

of negligible incremental risk (NIR). The NIR concept is based upon an

NCRP concept known as ``negligible incremental dose'' (NID, discussed

in more detail later in this notice) which was described by NAS ``as a

level of effective dose that can, for radiation protection purposes, be

dismissed from consideration'' (NAS Report pp. 59-60). Commenters also

stated that they did not support the NAS'' rejection of a collective-

dose standard. Comments were divided upon requiring quantitative or

qualitative assessment of human intrusion.

With regard to the three questions posed in the EnPA: (1) There

were mixed responses upon whether a standard to protect individuals

could adequately protect the general public; (2) there was nearly

unanimous agreement that active institutional controls cannot prevent a

breach of the repository; and (3) there was nearly unanimous agreement

that it is impossible to predict the probability of future human

intrusion into the repository.

Commenters also expressed views related to a number of other

issues. The majority favored:

(1) A standard expressed in terms of dose;

(2) The highest level of protection possible;

(3) Measuring compliance at the time of peak risk of the maximally

exposed individual;

(4) A reference biosphere to be specified by EPA;

(5) Including other local sources of man-made radiation in

determining an acceptable level of protection;

s related to a number of other

issues. The majority favored:

(1) A standard expressed in terms of dose;

(2) The highest level of protection possible;

(3) Measuring compliance at the time of peak risk of the maximally

exposed individual;

(4) A reference biosphere to be specified by EPA;

(5) Including other local sources of man-made radiation in

determining an acceptable level of protection;

(6) Protection equal to that specified for WIPP, that is, that in

40 CFR part 191 (WIPP is a geologic disposal system in New Mexico for

defense-related transuranic waste but, unlike Yucca Mountain, WIPP is

subject to our generic radioactive-waste standards codified at 40 CFR

part 191; see also 61 FR 5224, February 9, 1996);

(7) Using a collective-dose limit to restrict exposure to the

general population while ignoring the NIR concept;

(8) Including assurance requirements; and

(9) Including ground water protection requirements.

We have taken into consideration all comments received during

preparation of these proposed standards. If you submitted comments in

response to the September 11, 1995, Federal Register notice or at the

September 1995 public hearings, you should submit additional comments

in response to today's notice to convey any concerns or views about

this proposal.

III. What Are We Proposing Today?

We are proposing, and requesting comment upon, public health and

safety standards governing the storage and disposal of SNF, HLW, and

other radioactive material in the repository at Yucca Mountain, Nevada.

We are also announcing a public comment period and public hearings to

gather comments upon the proposal

onvey any concerns or views about

this proposal.

III. What Are We Proposing Today?

We are proposing, and requesting comment upon, public health and

safety standards governing the storage and disposal of SNF, HLW, and

other radioactive material in the repository at Yucca Mountain, Nevada.

We are also announcing a public comment period and public hearings to

gather comments upon the proposal.

As noted earlier, section 801(a)(1) of the EnPA gave us rulemaking

authority to set ``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.''

The statute also directed us to develop standards ``based upon and

consistent with the findings and recommendations of the National

Academy of Sciences.'' Section 801(a)(2) of the EnPA directed us to

contract with NAS to conduct a study to provide findings and

recommendations on reasonable standards for protection of the public

health and safety. Because the EnPA called for us to act ``based upon

and consistent with'' the NAS findings, a major issue in this

rulemaking is whether we are bound to follow the NAS determinations

without exception or whether we have discretionary decision-making

authority.

As a practical matter, the difficulty of this issue is reduced

because some of the findings and recommendations in the NAS Report are

expressed in a non-binding manner. In other words, NAS stated its

findings and recommendations as starting points for the rulemaking

process or recognized those that involve public policy issues that are

more properly addressed in this public rulemaking proceeding. However,

the Report also contains some findings and recommendations stated in

relatively definite terms. It is these issues that most squarely

present the question of whether we are to treat the views of NAS as

binding

ions as starting points for the rulemaking

process or recognized those that involve public policy issues that are

more properly addressed in this public rulemaking proceeding. However,

the Report also contains some findings and recommendations stated in

relatively definite terms. It is these issues that most squarely

present the question of whether we are to treat the views of NAS as

binding.

Whether the EnPA binds us to following exactly the NAS findings and

recommendations is a question that warrants close attention at this

stage of the rulemaking because it affects the scope of our rulemaking.

If we are required to follow every view expressed in the NAS Report,

any such issue would be treated as addressed conclusively by NAS. We

would not need to entertain public comment upon the affected issues

since the outcome would be predetermined.

We believe that the EnPA does not bind us absolutely to follow the

NAS Report. Instead, we have used the NAS Report as the starting point

for this rulemaking. Today's proposal is based upon and consistent with

the findings and recommendations of NAS. We have developed this

proposal guided by the findings and recommendations of NAS because of

the special role given NAS by Congress and the scientific expertise of

NAS. However, the entirety of our proposed standards for the Yucca

Mountain disposal system is the subject of this rulemaking. We do not

intend to treat the views expressed by NAS as necessarily dictating the

outcome of this rulemaking, thereby foreclosing public scrutiny of

important issues. For the reasons described below, we believe this

proposed interpretation of the EnPA is consistent with the statute and

prudent in that it avoids potential Constitutional issues. Further,

this proposed interpretation supports an important EPA policy

objective--ensuring an opportunity for public input upon all aspects of

the issues presented in this rulemaking

ic scrutiny of

important issues. For the reasons described below, we believe this

proposed interpretation of the EnPA is consistent with the statute and

prudent in that it avoids potential Constitutional issues. Further,

this proposed interpretation supports an important EPA policy

objective--ensuring an opportunity for public input upon all aspects of

the issues presented in this rulemaking.

Section 801(a)(2) of the EnPA required a study by NAS that provides

``findings and recommendations on reasonable standards for protection

of the public health and safety.'' While this section of the EnPA calls

for NAS to address three specific issues, Congress did not place any

restrictions upon other issues NAS could address. The report of the

Congressional conferees underscored that ``the National Academy of

Sciences would not be precluded from addressing additional questions or

issues related to the appropriate standards for radiation protection at

Yucca Mountain beyond those that are specified.'' (H.R. Rep. No. 1018,

102nd Cong., 2d Sess. 391 (1992)). Thus, given the potentially

unlimited scope of the NAS inquiry under the statute, NAS could have

provided findings and recommendations that would dictate literally all

aspects of the public health and safety standards for Yucca Mountain,

rendering our function a ministerial one.

Section 801(a)(1) of the EnPA plainly gave EPA the authority to

issue, by rulemaking, public health and safety standards for Yucca

Mountain. If at the same time that Congress gave NAS the authority to

provide findings and recommendations on any issues related to the Yucca

Mountain public health and safety standards, Congress also intended

that NAS' findings and recommendations be binding upon us, then

Congress would have effectively delegated to NAS a standard-setting

authority that overrides our delegated rulemaking authority

in. If at the same time that Congress gave NAS the authority to

provide findings and recommendations on any issues related to the Yucca

Mountain public health and safety standards, Congress also intended

that NAS' findings and recommendations be binding upon us, then

Congress would have effectively delegated to NAS a standard-setting

authority that overrides our delegated rulemaking authority. Carried to

its logical conclusion, under this view of the statute, NAS would have

authority to establish the public health and safety standards, and to

do so without a public rulemaking process. Then the direction for EPA

to set standards ``by rule'' would be unnecessary or relatively

meaningless. This tension in the statute can be reasonably resolved by

interpreting the NAS' findings and recommendations as non-binding, but

highly influential, expert guidance to inform our rulemaking.

Thus, we do not believe the statute forces our rulemaking to adopt

mechanically the NAS' recommendations as standards. If it did, the

statutory provisions would allow us to consider only those issues that

NAS did not address. Further, the provisions calling for us to use

standard rulemaking procedures in issuing the standards would be

unnecessary to reach results that NAS already established.

The report of the conferees also indicates that Congress did not

intend to limit our rulemaking discretion. The Conference Report

provides that Congress intended NAS to provide ``expert scientific

guidance'' on the issues involved in our rulemaking and that Congress

did not intend for NAS to establish the specific standards:

would be

unnecessary to reach results that NAS already established.

The report of the conferees also indicates that Congress did not

intend to limit our rulemaking discretion. The Conference Report

provides that Congress intended NAS to provide ``expert scientific

guidance'' on the issues involved in our rulemaking and that Congress

did not intend for NAS to establish the specific standards:

The Conferees do not intend for the National Academy of

Sciences, in making its recommendations, to establish specific

standards for protection of the public but rather to provide expert

scientific guidance on the issues involved in establishing those

standards. Under the provisions of section 801, the authority and

responsibility to establish the standards, pursuant to rulemaking,

would remain with the Administrator, as is the case under existing

law. The provisions of section 801 are not intended to limit the

Administrator's discretion in the exercise of his authority related

to public health and safety issues. (H.R. Rep. No. 1018 at p. 391)

Our proposed interpretation of the EnPA as not limiting the issues

for consideration in this rulemaking is consistent with the views we

expressed to Congress during deliberations over the legislation. The

Chairman of the Senate Subcommittee on Nuclear Regulation requested our

views of the bill reported out of conference. The Deputy Administrator

of EPA indicated that the NAS Report would provide helpful input.

Moreover, EPA's Deputy Administrator pointed to the language, cited

above, stating the intent of the conferees not to limit our rulemaking

discretion and assured Congress that any standards for radioactive

materials that we ultimately issue would be the subject of public

comment and involvement and would fully protect human health and the

environment. (138 Cong. Rec. S33,955 (daily ed. October 8, 1992)).

Our proposed interpretation also is consistent with the role that

both NAS and Congress understood NAS would fulfill

lemaking

discretion and assured Congress that any standards for radioactive

materials that we ultimately issue would be the subject of public

comment and involvement and would fully protect human health and the

environment. (138 Cong. Rec. S33,955 (daily ed. October 8, 1992)).

Our proposed interpretation also is consistent with the role that

both NAS and Congress understood NAS would fulfill. During the

Congressional deliberations over the legislation, NAS informed Congress

that while it would conduct the study, it would not assume a standard-

setting role because that is properly the responsibility of government

officials. (138 Cong. Rec. S33,953 (October 8, 1992)).

Our proposed interpretation of the NAS Report also avoids

implicating potentially significant Constitutional issues. Construing

the EnPA as delegating to NAS the responsibility to determine the

health and safety standards at Yucca Mountain may violate the

Appointments Clause of the Constitution (Art. II, sec. 2, cl. 2), which

imposes restrictions against giving Federal governmental authority to

persons not appointed in compliance with that Clause. In addition, the

Constitution places restrictions arising under the separation of powers

doctrine upon the delegation of governmental authority to persons not

part of the Federal government. We are not concluding, at this time,

that an alternative interpretation would necessarily run afoul of

Constitutional limits. However, we believe it is reasonable both to

assume that Congress intended to avoid these issues when it adopted

section 801 of the EnPA and to interpret the EnPA accordingly.

In summary, we do not believe we must, in this rulemaking, adopt

all of the positions advanced by NAS. At the same time, the statute

does give NAS a special role. As noted, the NAS' findings and

recommendations have been the starting point for this rulemaking and

our proposal is consonant with those findings and recommendations

d

section 801 of the EnPA and to interpret the EnPA accordingly.

In summary, we do not believe we must, in this rulemaking, adopt

all of the positions advanced by NAS. At the same time, the statute

does give NAS a special role. As noted, the NAS' findings and

recommendations have been the starting point for this rulemaking and

our proposal is consonant with those findings and recommendations. In

fact, the NAS Report influenced us heavily during the development of

this proposed rule. We have included many of the findings and

recommendations in whole in today's proposal, and we intend to continue

to weigh the NAS Report heavily throughout the course of this

rulemaking. We will tend to give greatest weight to the judgments of

NAS about issues having a strong scientific component, the area where

NAS has its greatest expertise. In addition, we will reach final

determinations that are congruent with the NAS analysis whenever we can

do so without departing from the Congressional delegation of authority

to us to

promulgate, by rule, public health and safety standards for protection

of the public, which we believe requires the consideration of public

comment and our own expertise and discretion.

We request public comment upon how we should view and weigh the

NAS' findings and recommendations in this rulemaking. Public commenters

should also address this issue in the context of the specific issues

presented in this rulemaking. Commenters should indicate whether we

have given proper consideration to the NAS' findings and

recommendations, whether we should give them more or less weight, and

what the resulting outcome should be.

The following sections describe our proposed public health and

safety standards for Yucca Mountain and the considerations which

underlie the set of standards we are proposing today. The next section

addresses the storage portion of the proposed standards. All of the

other sections pertain to the disposal portion of the standards.

more or less weight, and

what the resulting outcome should be.

The following sections describe our proposed public health and

safety standards for Yucca Mountain and the considerations which

underlie the set of standards we are proposing today. The next section

addresses the storage portion of the proposed standards. All of the

other sections pertain to the disposal portion of the standards.

III.A. What Is the Proposed Standard for Storage of the Waste?

(Proposed Subpart A)

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 mined portion of the facility constructed underground within the

Yucca Mountain site. Hereafter, the term ``repository'' refers to the

Yucca Mountain repository.) The EnPA differentiates between waste that

is ``stored'' and waste that is ``disposed,'' although it indicates

that we must issue standards that apply to both types of activity.

Congress was not clear regarding its intended use of the word

``stored'' in this context. Also, NAS did not address the issue of

storage (see proposed Secs. 197.2 and 197.12 for our proposed

definitions of ``storage'' and ``disposal''). The Yucca Mountain

repository currently is conceived to be a disposal facility, not a

storage facility, but that could change. Therefore, we propose to

interpret this language as directing us to develop standards that apply

to waste that DOE either stores or disposes of in the Yucca Mountain

repository. The public health and safety standards we issue under

section 801 of the EnPA would, therefore, apply to waste inside of the

repository, whether it is there for storage or disposal.

The Department will also handle and might store radioactive

material aboveground (that is, outside the repository). Those

activities are covered by our previously promulgated standards for

management and storage, codified at subpart A of 40 CFR part 191

issue under

section 801 of the EnPA would, therefore, apply to waste inside of the

repository, whether it is there for storage or disposal.

The Department will also handle and might store radioactive

material aboveground (that is, outside the repository). Those

activities are covered by our previously promulgated standards for

management and storage, codified at subpart A of 40 CFR part 191. The

40 CFR part 191 standards require that DOE manage and store SNF, HLW,

and transuranic radioactive wastes at a site, such as Yucca Mountain,

in a manner that provides a reasonable expectation that the annual dose

equivalent to any member of the public in the general environment will

not exceed 25 millirem (mrem) to the whole body. This is the standard

which DOE must meet for WIPP and the greater confinement disposal (GCD)

facility. (The GCD facility is a group of 120-feet deep boreholes

located within the Nevada Test Site (NTS) which contains disposed

transuranic wastes.)

The storage standards in 40 CFR 191.03(a) are stated in terms of an

older dose-calculation method and are set at an annual whole-body-dose

limit of 25 mrem/yr. The proposed storage standards for Yucca Mountain

use a modern dose-calculation method known as ``committed effective

dose equivalent'' (CEDE).8 Even though today's proposal uses

the modern method of dose calculation, we believe that the proposed

dose level essentially maintains a similar risk level as in 40 CFR

191.03(a) at the time of its promulgation (see the discussion of the

different dose-calculation methods in the What Should the Level of

Protection Be? section later in this notice). The difference between

these dose calculation procedures presents a problem in combining the

doses for regulatory purposes. However, we have begun a rulemaking to

amend both 40 CFR Parts 190 and 191. That rulemaking would update these

limits to the CEDE methodology

scussion of the

different dose-calculation methods in the What Should the Level of

Protection Be? section later in this notice). The difference between

these dose calculation procedures presents a problem in combining the

doses for regulatory purposes. However, we have begun a rulemaking to

amend both 40 CFR Parts 190 and 191. That rulemaking would update these

limits to the CEDE methodology. We anticipate that we will finalize the

amendments to parts 190 and 191 prior to the finalization of this

rulemaking. If that does not occur, we would need to address the

calculation of doses under the two methods in another fashion. For

example, we could require that the doses occurring as a result of

activities outside the repository be converted into annual CEDE for

purposes of determining compliance with the storage standard. We

request comments upon such an approach.

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

\8\ The term ``committed effective dose'' in this rulemaking has

the same meaning as the term ``committed effective dose equivalent''

which was used prior to the publication of ICRP Publication No. 60.

It is used here since the term is less complicated and more compact.

Also, the use of ``committed effective dose'' is consistent with

subpart B of 40 CFR part 191 (58 FR 66398, 66402, December 20,

1993).

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

he term ``committed effective dose equivalent''

which was used prior to the publication of ICRP Publication No. 60.

It is used here since the term is less complicated and more compact.

Also, the use of ``committed effective dose'' is consistent with

subpart B of 40 CFR part 191 (58 FR 66398, 66402, December 20,

1993).

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

Section 801 of the EnPA specifically provides that the standards

that we issue shall be the only ``such standards'' that apply at Yucca

Mountain. Thus, the statute provides that the EnPA is the exclusive

authority for ``such standards'' and, in turn, replaces our generally

applicable standards for radiation protection to the extent that

section 801 requires site-specific standards. Otherwise, our generic

standards are not affected. As noted, we propose to interpret the scope

of section 801 as applying to both storage and disposal of waste in the

repository. Thus, waste inside the repository would be subject to the

standards proposed in today's notice. Our generic standards in subpart

A of 40 CFR part 191 will apply to waste outside of the repository.

Using this interpretation, we have considered the differences

between the conditions covered by the storage standards in 40 CFR

191.03(a) and the conditions which could affect storage in the Yucca

Mountain repository. The most significant difference is that the

storage in Yucca Mountain would be underground whereas most storage

covered under 40 CFR part 191 is aboveground. Otherwise, the technical

situations we anticipate under both the existing generic standards and

the proposed Yucca Mountain standards are essentially the same. Also,

one of our goals in issuing 40 CFR parts 190 and 191 was to bring the

entire uranium fuel cycle under consistent EPA standards

Yucca Mountain would be underground whereas most storage

covered under 40 CFR part 191 is aboveground. Otherwise, the technical

situations we anticipate under both the existing generic standards and

the proposed Yucca Mountain standards are essentially the same. Also,

one of our goals in issuing 40 CFR parts 190 and 191 was to bring the

entire uranium fuel cycle under consistent EPA standards. Therefore, we

are proposing that the part 197 standards continue the coverage of the

uranium fuel cycle because SNF, a large part of the waste planned for

emplacement in Yucca Mountain, is part of that fuel cycle. Therefore,

we are proposing to extend a similar level of protection as in the 1985

version of subpart A of 40 CFR part 191. In other words, under the part

197 storage standards, exposures of members of the public from waste

storage inside the repository would be combined with exposures

occurring as a result of storage outside the repository but within the

Yucca Mountain site. The total dose could be no greater than 150

microsieverts (Sv) (15 mrem) CEDE per year (CEDE/yr).

Our application of subpart A of 40 CFR part 191 to storage

activities outside of the repository at the Yucca Mountain site is

supported by the WIPP LWA. Section 8 of the WIPP LWA excludes Yucca

Mountain from our generic disposal standards but not from the generic

management and storage standards found in subpart A of 40 CFR part 191.

If we finalize the proposed interpretation of section 801 of the EnPA

as applying to radioactive material stored or disposed of in the

repository, we would apply subpart A of 40 CFR part 191 to the storage

activities outside of the repository at the site without further public

notice.

l standards but not from the generic

management and storage standards found in subpart A of 40 CFR part 191.

If we finalize the proposed interpretation of section 801 of the EnPA

as applying to radioactive material stored or disposed of in the

repository, we would apply subpart A of 40 CFR part 191 to the storage

activities outside of the repository at the site without further public

notice.

We request comment upon our proposed interpretation that section

801 of the EnPA directs us to develop new standards that apply only to

radioactive materials stored in the repository. We also request public

comment upon whether we should instead construe section 801 of the EnPA

as providing for the establishment of new storage standards, rather

than applying the existing storage standards in 40 CFR part 191 to

storage, or handling, of radioactive materials at the Yucca Mountain

site prior to their movement into the repository. If we decide, based

upon the alternative interpretation of section 801, to promulgate new

storage standards for the site, we anticipate that we would adopt

standards essentially the same as those in 40 CFR 191.03(a). Thus, we

request public comment upon whether we should develop and adopt in this

rulemaking, under section 801 of the EnPA, new standards for management

and storage activities at the site, and request comments upon the

adoption of such standards based upon those in 40 CFR 191.03(a).

III.B. What Is the Standard for Protection of Individuals? (Proposed

Secs. 197.20 and 197.25)

0 CFR 191.03(a). Thus, we

request public comment upon whether we should develop and adopt in this

rulemaking, under section 801 of the EnPA, new standards for management

and storage activities at the site, and request comments upon the

adoption of such standards based upon those in 40 CFR 191.03(a).

III.B. What Is the Standard for Protection of Individuals? (Proposed

Secs. 197.20 and 197.25)

III.B.1. Should the Limit Be on Dose or Risk?

Although a standard for limiting exposure of people to radiation

can take many forms, NAS narrowed its final considerations to risk and

dose, that is, a risk-based or dose--based standard. The numeric level

of the proposed standard for protecting individual members of the

public from radioactive materials disposed of in the Yucca Mountain

disposal system is addressed in the What Should the Level of Protection

Be? section later in this notice. The discussion here explains why we

selected a dose-based standard rather than a risk-based standard, as

recommended by NAS.

Two forms of radiation exposure can occur depending upon the

location of the source relative to the body `` internal and external.

Internal exposures occur when a person inhales or ingests contaminated

air, food, water, or soil. External exposures occur because a person is

near a radionuclide which is emitting X-rays, gamma rays, beta

particles, or neutrons. ``Dose'' is a measure of the amount of

radiation received by individuals resulting from exposure to

radionuclides. ``Risk'' is the probability of an individual incurring

an adverse health effect from exposure to radiation. The NAS defined

``risk'' as the product of two parameters: (1) the probability of an

individual receiving a dose, and (2) the probability of incurring a

health effect because of that dose (NAS Report p. 42). This rulemaking

takes both of these factors into account

ure to

radionuclides. ``Risk'' is the probability of an individual incurring

an adverse health effect from exposure to radiation. The NAS defined

``risk'' as the product of two parameters: (1) the probability of an

individual receiving a dose, and (2) the probability of incurring a

health effect because of that dose (NAS Report p. 42). This rulemaking

takes both of these factors into account. (The probability of an

individual receiving a dose is part of the performance assessment and

is discussed in the What Are the Requirements for Performance

Assessments and Determinations of Compliance? section later in this

notice.) As mentioned in the previous section, these standards state

radiation risk estimates as the probability of an individual developing

a fatal cancer, since fatal cancers are the greatest harm to

individuals from low-dose-rate radiation (NAS pp. 37-39).

Section 801(a)(1) of the EnPA directed that our standards for Yucca

Mountain ``shall prescribe the maximum annual effective dose equivalent

to individual members of the public from releases to the accessible

environment from radioactive materials stored or disposed of in the

repository....'' At the same time, the EnPA calls for us to issue our

standards ``based upon and consistent with'' the findings and

recommendations of NAS. The NAS recommended that we adopt a standard

expressed as risk rather than the dose standard that Congress

prescribed. The NAS offered two reasons for its recommendation. First,

a risk-based standard is advantageous relative to a dose-based standard

because it ``would not have to be revised in subsequent rulemakings if

advances in scientific knowledge reveal that the dose-response

relationship is different from that envisaged today'' (NAS Report p.

64). Second, a standard in the form of risk more readily enables the

public to comprehend and compare the standard with human-health risks

from other sources.

We have reviewed and evaluated the merits of a risk-based standard

as recommended by NAS

ulemakings if

advances in scientific knowledge reveal that the dose-response

relationship is different from that envisaged today'' (NAS Report p.

64). Second, a standard in the form of risk more readily enables the

public to comprehend and compare the standard with human-health risks

from other sources.

We have reviewed and evaluated the merits of a risk-based standard

as recommended by NAS. However, we are proposing a dose-based standard

for the following reasons. First, both national and international

radiation protection guidelines developed by bodies of non-governmental

radiation experts, such as ICRP and NCRP, generally have recommended

that radiation standards be established in terms of dose. Also,

national and international radiation standards, including the

individual-protection requirements in 40 CFR part 191, are established

almost solely in terms of dose or concentration, not risk. Therefore, a

risk-based standard will not allow a convenient comparison with the

numerous existing radiation guidelines and standards that are stated in

terms of dose.

Second, we have an established methodology for calculating dose

that is described in Federal Guidance Reports Nos. 11 and 12 (Federal

Guidance). The development of this methodology was a combined effort of

many Federal agencies involved in radiation protection and has become

Federal policy. The guidance provides a consistent methodology for

calculating doses for regulatory purposes. By contrast, there is

currently no Federal Guidance Report, in final form, for calculating

risk from radiation exposure.

Third, we have based the proposed dose-based standard upon the risk

of developing a fatal cancer as a result of that level of exposure

based upon a linear, non-threshold, dose-response relationship. We

would establish a risk-based standard in the same manner

tory purposes. By contrast, there is

currently no Federal Guidance Report, in final form, for calculating

risk from radiation exposure.

Third, we have based the proposed dose-based standard upon the risk

of developing a fatal cancer as a result of that level of exposure

based upon a linear, non-threshold, dose-response relationship. We

would establish a risk-based standard in the same manner. Thus, a risk-

based standard, like a dose-based standard, depends upon current

knowledge and assumptions about the chance of developing fatal cancer

from a particular exposure level. Dose and risk are closely related;

one can be converted to the other simply by using the appropriate

factor. Therefore, both dose- and risk-based standards are based upon

scientific assumptions that could change and no matter how it is

expressed, the standard is based upon risk.

Finally, section 801(a)(1) of the EnPA specifically calls for a

dose-based standard. Most commenters supported this by asking for a

dose-based standard rather than a risk-based standard.

Accordingly, we are proposing a standard expressed as a limit on

dose. We are requesting comments upon the proposed form of the

standard, including whether the standard should be expressed as risk.

III.B.2. What Should the Level of Protection Be?

As noted previously, section 801(a)(1) of the EnPA calls for our

Yucca Mountain standards to ``prescribe the maximum annual effective

dose equivalent to individual members of the public from releases of

radioactive materials.'' Development of the individual-protection

standard requires us to evaluate and specify several factors. These

factors include the level of protection, who the standards should

protect, and how long the standards should provide protection.

Determining the appropriate dose level is ultimately a question of both

science and public policy. The NAS stated in its Report: ``The level of

protection established by a standard is a statement of the level of the

risk that is acceptable to society

factors. These

factors include the level of protection, who the standards should

protect, and how long the standards should provide protection.

Determining the appropriate dose level is ultimately a question of both

science and public policy. The NAS stated in its Report: ``The level of

protection established by a standard is a statement of the level of the

risk that is acceptable to society. Whether posed as ``How safe is safe

enough?'' or as ``What is an acceptable

level?'', the question is not solvable by science'' (NAS Report p. 49).

We seek to find answers to these questions for the Yucca Mountain

disposal system through this rulemaking.

We considered the NAS findings and recommendations in our

determination of the CEDE level that would be adequately protective of

human health. We also reviewed established EPA standards and guidance,

other Federal agencies' actions for both radiation and non-radiation-

related actions, and other countries' regulations. In addition, we

evaluated guidance on dose limits provided by National and

international, non-governmental, advisory groups of radiation experts.

The NAS recommended a range of risk levels that we could use as a

reasonable starting point in this rulemaking (NAS Report p. 5). The

range of annual risk of fatal cancer suggested by NAS was 1 chance in

100,000 (1 x 10-\5\) to 1 chance in 1,000,000 (1 x

10-\6\) (this corresponds to a range of 20 to 2 mrem CEDE/

yr). The NAS based its recommendation upon its review and evaluation of

our actions, other Federal actions, guidelines developed by National

and international groups, and regulations of other countries. For these

standards, we are proposing a limit of 150 Sv (15 mrem) CEDE/

yr. This limit corresponds approximately to an annual risk of 7 chances

in 1,000,000 (7 x 10-\6\)--within the range that NAS

recommended as a starting point for consideration.

Table 1 below lists the dose limits of other current EPA and NRC

regulations (adapted from NAS Report p. 50)

s, and regulations of other countries. For these

standards, we are proposing a limit of 150 Sv (15 mrem) CEDE/

yr. This limit corresponds approximately to an annual risk of 7 chances

in 1,000,000 (7 x 10-\6\)--within the range that NAS

recommended as a starting point for consideration.

Table 1 below lists the dose limits of other current EPA and NRC

regulations (adapted from NAS Report p. 50). Today's proposed standard

of 150 Sv (15 mrem) CEDE/yr is within the range of these

established standards. Further, it is consistent with the individual-

protection standard at 40 CFR 191.15 in our generic disposal standards

which limits the annual CEDE to 150 Sv (15 mrem)/yr.

Table 1.--Current EPA and NRC Dose Limits on Various Environmental

Concerns

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

Environmental concern Limit*

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

Low-Level Waste (10 CFR part 61)....... 250 Sv (25 mrem)/yr

License Termination (10 CFR part 20)... 25 mrem TEDE**/yr

Uranium Fuel Cycle (40 CFR part 190)... 25 mrem/yr

Generic Standard for Management and 25 mrem/yr

Storage of SNF and HLW (40 CFR 191.03).

Generic Individual-Dose Standard for 150 Sv (15 mrem) CEDE/

Disposal of SNF and HLW (40 CFR yr

191.15).

National Emission Standards for 10 mrem CEDE/yr

Hazardous Air Pollutants (40 CFR part

61, subparts H and I).

SNF and HLW Disposal Limit for 4 mrem/yr for man-made beta-

Underground Sources of Drinking Water and photon-emitting

(40 CFR 191.24). radionuclides

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

*Unless otherwise noted, only whole-body dose limits are listed; there

may also be other requirements for any particular environmental

concern. The 25-mrem/yr, whole-body-dose limit established in 1985 is

essentially equivalent to the risk associated with today's dose rate

of 150 Sv (15 mrem) CEDE/yr (58 FR 66402, December 20, 1993).

**TEDE (total effective dose equivalent) is NRC's term for CEDE

ss otherwise noted, only whole-body dose limits are listed; there

may also be other requirements for any particular environmental

concern. The 25-mrem/yr, whole-body-dose limit established in 1985 is

essentially equivalent to the risk associated with today's dose rate

of 150 Sv (15 mrem) CEDE/yr (58 FR 66402, December 20, 1993).

**TEDE (total effective dose equivalent) is NRC's term for CEDE. This

regulation was not included in the NAS Report.

We note that, except for 40 CFR 191.15, 40 CFR part 61, and 10 CFR

part 20, the dose limits in Table 1 are stated in terms of an old dose

system. For example, the annual limits in 40 CFR 191.03(a) are 25 mrem

for the whole body, 75 mrem for the thyroid, or 25 mrem for any other

organ (only the whole-body limit is listed in Table 1). We established

these dose levels in 1985 (50 FR 38085, September 19, 1985) under a

different system for calculating doses than the more recent rulemakings

that use the CEDE concept. We estimate that the 25-mrem/yr, whole-body-

dose limit established in 1985 is essentially equivalent to the risk

associated with today's proposed limit of 150 Sv (15 mrem)

CEDE/yr (58 FR 66398, 66402, December 20, 1993).

In addition, the proposed 150-Sv (15 mrem)-CEDE/yr limit

in today's proposal is consistent with other current standards. For

example, our limits on radiation exposure through the air is part of

the set of limits for pollutant releases known as the National Emission

Standards for Hazardous Air Pollutants (NESHAPs, 40 CFR part 61). Since

our NESHAPs limit of 10 mrem/yr covers radionuclide releases into only

the air, the 150 Sv (15 mrem) CEDE/yr standard being proposed

for 40 CFR part 197 is consistent with the NESHAPs limit because it

applies to all potential pathways, that is, the dose limit is higher

but includes other pathways in the analysis

Emission

Standards for Hazardous Air Pollutants (NESHAPs, 40 CFR part 61). Since

our NESHAPs limit of 10 mrem/yr covers radionuclide releases into only

the air, the 150 Sv (15 mrem) CEDE/yr standard being proposed

for 40 CFR part 197 is consistent with the NESHAPs limit because it

applies to all potential pathways, that is, the dose limit is higher

but includes other pathways in the analysis.

In summary, based upon our review of the guidance, regulations, and

standards cited above, and the NAS Report, we are proposing a standard

of 150 Sv (15 mrem) CEDE/yr for the Yucca Mountain disposal

system. We request comment upon the reasonableness of this level of

protection.

III.B.3. What Factors Can Lead to Radiation Exposure?

Protection of the public from exposure to radioactive pollutants

requires knowledge and understanding of three factors: the source of

the radiation, the pathways leading to exposure, and the recipients of

the radiation. This section provides a discussion of the source of

radiation and pathways of exposure. The following two sections discuss

the recipients of the dose. The development of standards to protect

public health and safety from radionuclides released from waste

disposed of in the Yucca Mountain disposal system must include

consideration of the sources of radiation and pathways which could lead

to exposure of humans. The mechanisms of exposure are the basis of an

analysis called the performance assessment. The performance assessment

is the quantitative analysis of the projected behavior of the disposal

system.

Source. The waste disposed of in Yucca Mountain will contain many

different radionuclides including unconsumed uranium, fission products

(for example, cesium-137 and strontium-90), and transuranic elements

(for example, plutonium and americium)

analysis called the performance assessment. The performance assessment

is the quantitative analysis of the projected behavior of the disposal

system.

Source. The waste disposed of in Yucca Mountain will contain many

different radionuclides including unconsumed uranium, fission products

(for example, cesium-137 and strontium-90), and transuranic elements

(for example, plutonium and americium).

The inventory of radionuclides over time will depend upon the type

and amount of radionuclides originally disposed of in the disposal

system, the half-lives of the radionuclides, and the amount of any

radionuclides formed from the decay of parent radionuclides (see the

BID). In the time frame of tens-to hundreds-of-thousands of years, most

radionuclides initially present in SNF and HLW will decay to

essentially no radioactivity. Therefore, the waste will eventually have

radiologic characteristics similar to a large uranium ore body (see the

BID).

To delay the movement of radionuclides into the biosphere, DOE

plans to use multiple barriers. These barriers would be man-made

(engineered) and natural based upon the design of, and conditions in

and around, the disposal system.

Engineered barriers must be designed to delay release of

radionuclides from the repository. For example, an engineered barrier

could be the waste form. The Department plans to convert liquid HLW

derived from reprocessing of SNF into a solid by entraining the

radionuclides into a matrix of borosilicate glass; NRC will likely

consider this an engineered barrier. The molten glass then would be

poured into and hardened in a second man-made barrier, a metal

container (see the BID). In addition, it is possible to have other man-

made barriers in the repository to serve as part of the disposal system

(see the BID).

Natural barriers at Yucca Mountain also could slow the movement of

radionuclides into the accessible environment

r this an engineered barrier. The molten glass then would be

poured into and hardened in a second man-made barrier, a metal

container (see the BID). In addition, it is possible to have other man-

made barriers in the repository to serve as part of the disposal system

(see the BID).

Natural barriers at Yucca Mountain also could slow the movement of

radionuclides into the accessible environment. For instance, the

Department plans to construct the repository in a layer of tuff located

above the water table. The relative dryness of the tuff around the

repository would limit the amount of water which comes into contact

with the waste. It also would retard the future movement of

radionuclides from the waste into the underlying aquifer. Any

radioactive material that dissolved into infiltrating water,

originating as surface precipitation, still would have to be moved to

the saturated zone. Minerals, such as zeolites, contained within the

tuff beneath the repository could act as molecular filters and ion-

exchange agents for some of the released radionuclides, thereby slowing

their movement. Such minerals also could limit the amount of water that

contacts the waste and could help retard the movement of radionuclides

from the waste to the water table. This mechanism would be most

effective if flow was predominantly through the pores in the rock, also

known as the matrix (see the BID).

Pathways. Once radionuclides have left the waste packages, they

could be carried by water or air and reach the public. Upon release

from the waste packages, most radionuclides will be carried by ground

water away from the repository. However, those in a gaseous form, such

as carbon-14 (\14\C) in the form of carbon dioxide, will be carried by

air moving through the mountain.

Movement via water. Radionuclides will not be moved into the water

table instantaneously. The length of time it takes depends partly upon

how much the water moves via fractures or through the matrix of the

rock

ground

water away from the repository. However, those in a gaseous form, such

as carbon-14 (\14\C) in the form of carbon dioxide, will be carried by

air moving through the mountain.

Movement via water. Radionuclides will not be moved into the water

table instantaneously. The length of time it takes depends partly upon

how much the water moves via fractures or through the matrix of the

rock. Once radionuclides reach the saturated zone, they would move away

from the disposal system in the direction of ground water flow.

There are currently no perennial rivers or lakes adjacent to Yucca

Mountain to further transport contaminants. Therefore, based upon

current knowledge and conditions, ground water and its usage will

likely be the main pathway leading to exposure of humans. Current

knowledge suggests that the two major ways that people would use the

contaminated ground water are: (1) drinking and domestic uses; and (2)

agricultural uses (see the BID). In other words, radionuclides that

reach the public could deliver a dose if an individual: (1) Drinks

contaminated ground water or uses it directly for other household uses;

(2) drinks other liquids containing contaminated water; (3) eats food

products processed using contaminated water; (4) eats vegetables or

meat raised using contaminated water, or (5) is otherwise exposed as a

result of immersion in contaminated water or air or inhalation of wind-

driven particulates left following the evaporation of the water.

Movement via air. Some radionuclides could be carried by moving

air. The largest known source of potential movement by air in Yucca

Mountain is carbon dioxide containing \14\C. Airborne radionuclides

might move through the tuff overlying the repository and exit into the

atmosphere following release from the waste package. Once the

radioactive gas enters the atmosphere, it would disperse. This

dispersion would probably be global and, therefore, become greatly

diluted

gest known source of potential movement by air in Yucca

Mountain is carbon dioxide containing \14\C. Airborne radionuclides

might move through the tuff overlying the repository and exit into the

atmosphere following release from the waste package. Once the

radioactive gas enters the atmosphere, it would disperse. This

dispersion would probably be global and, therefore, become greatly

diluted. The major pathway for exposure of people by \14\C is the

uptake of radioactive carbon dioxide by plants that humans subsequently

eat (see the BID).

III.B.4. Who Will Be Representative of the Exposed Population?

To determine whether the Yucca Mountain disposal system complies

with the standard, it will be necessary for DOE to calculate the dose

to 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 must specify, therefore, the individual

or group of individuals for whom the dose calculation is to be made.

The NAS definition of critical group. The NAS Report recommended

that we base the standards for protection of individuals upon risk

incurred by a critical group (CG). The CG would be the group of people

which, based upon cautious, but reasonable, assumptions, has the

highest risk of incurring health effects due to releases from the

disposal system. The ICRP introduced the concept of a CG in order to

account for the variation of dose which may occur in a population due

to differences in age, size, metabolism, habits, and environment. In

other words, the ICRP recommends the use of a group of people because

individuals might have personal traits which make them much more or

less vulnerable to releases of radiation than the average within a

small group of the most highly exposed individuals

account for the variation of dose which may occur in a population due

to differences in age, size, metabolism, habits, and environment. In

other words, the ICRP recommends the use of a group of people because

individuals might have personal traits which make them much more or

less vulnerable to releases of radiation than the average within a

small group of the most highly exposed individuals. The ICRP defines

the CG as a relatively homogeneous group of people whose location and

habits are such that they represent those individuals expected to

receive the highest doses as a result of the discharge of

radionuclides. The NAS adapted the CG concept to a risk framework for

the development of an individual-risk standard and recommended the

following description of the CG (NAS Report p. 53):

The critical group for risk should be representative of those

individuals in the population who, based on cautious, but

reasonable, assumptions, have the highest risk resulting from

repository releases. The group should be small enough to be

relatively homogeneous with respect to diet and other aspects of

behavior that affect risks. The critical group includes the

individuals at maximum risk and is homogeneous with respect to risk.

A group can be considered homogeneous if the distribution of

individual risk within the group lies within a total range of a

factor of ten and the ratio of the mean of individual risks in the

group to the standard is less than or equal to one-tenth. If the

ratio of the mean group risk to the standard is greater than or

equal to one, the range of risk within the group must be within a

factor of 3 for the group to be considered homogeneous. For groups

with ratios of mean group risk to the standard between one-tenth and

one, homogeneity requires a range of risk interpolated between these

limits.

standard is less than or equal to one-tenth. If the

ratio of the mean group risk to the standard is greater than or

equal to one, the range of risk within the group must be within a

factor of 3 for the group to be considered homogeneous. For groups

with ratios of mean group risk to the standard between one-tenth and

one, homogeneity requires a range of risk interpolated between these

limits.

The NAS also recommended that the CG risk calculated for purposes

of comparison with the risk limit established in the standard is the

average of the risks of all the members in the group. Using the average

risk avoids the problem of the outcome being unduly influenced by

unusual habits of individuals within the group.

The NAS indicated that in order to select a CG, the person or

persons likely

to be at highest risk from among the larger, exposed population must be

specified. To accomplish this, one must make assumptions about the

nature of human activities, lifestyles, and pathways that affect the

level of exposure. The set of circumstances that affects the dose

received, such as where people live, what they eat and drink, and other

lifestyle characteristics, is a very important part of the exposure

scenario. Many human behavior factors important to assessing repository

performance vary over periods that are short in comparison with the

compliance period proposed for these standards. The past several

centuries have seen radical changes in human technology and behavior,

many of which were not reasonably predictable. Given this potential for

rapid change, we believe that it is not possible to know what patterns

of human activity and changes in human biology might occur thousands of

years from now

short in comparison with the

compliance period proposed for these standards. The past several

centuries have seen radical changes in human technology and behavior,

many of which were not reasonably predictable. Given this potential for

rapid change, we believe that it is not possible to know what patterns

of human activity and changes in human biology might occur thousands of

years from now. For the purpose of compliance with the standard,

therefore, we are proposing that it is appropriate to use many of the

current characteristics of members of the public in the vicinity of

Yucca Mountain in the compliance assessments required by these

standards (see the What Should Be Assumed About the Future Biosphere?

section later in this notice).

The NAS Report presented two illustrative approaches for

formulating an exposure scenario for determining compliance. The NAS

also clearly stated that there might be other methods to reach the same

objective (NAS Report p. 100). One approach, described in Appendix C of

the NAS Report, A Probabilistic Critical Group, used statistical

methods and probabilities to characterize a CG. The second, The

Subsistence-Farmer Critical Group, described in Appendix D, identified

a subsistence farmer as a principal representative of the CG.

The NAS probabilistic critical group. Appendix C of the NAS Report

described a ``probabilistic critical group.'' This section describes

the contents of Appendix C of the NAS Report.

The NAS probabilistic CG approach would require use of a

theoretical population distribution which we would, or require DOE to,

develop by using a mathematical method known as ``Monte Carlo.'' The

Monte Carlo method is a mechanism to randomly select values of

parameters which have a range of possible values. The parameters would

be present-day environmental parameters, including soil quality, land

slope, growing season, depth to the aquifer, and population

distribution and lifestyles

hich we would, or require DOE to,

develop by using a mathematical method known as ``Monte Carlo.'' The

Monte Carlo method is a mechanism to randomly select values of

parameters which have a range of possible values. The parameters would

be present-day environmental parameters, including soil quality, land

slope, growing season, depth to the aquifer, and population

distribution and lifestyles. The individuals who comprise the CG may

represent a variety of economic lifestyles and activities. The analysis

would then use the variability of those parameters in the region around

Yucca Mountain to arrive at the theoretical population for the

calculation of radiation exposure. This theoretical population would

then, according to NAS, be combined with Monte Carlo simulations of the

distribution of contaminated ground water in time and space (NAS Report

p. 148). According to NAS, each simulation would generate a plume path

which could be overlain on a map of potential farm density or water use

to determine a potential exposure area. Each of these potential plume

paths is known as a ``realization.'' Values for parameters, including

well depths, rates of water use, food sources, and consumption rates,

are determined by sampling from the parameter-value distributions. For

each plume realization of the contamination in the aquifer, the results

of the exposure simulations are combined to give a spatial distribution

of maximum exposures for the locations likely to be inhabited. This

approach would use a large number of simulations of plume realizations

to identify critical subgroups with the highest risk. It would then be

used to calculate the arithmetic average of the risk of all critical

subgroups over all plume realizations to estimate the risk for the CG.

In determining compliance, the Commission would compare this estimate

with the risk limit in the standard.

We considered proposing the probabilistic CG approach but are not

doing so for the following reasons

groups with the highest risk. It would then be

used to calculate the arithmetic average of the risk of all critical

subgroups over all plume realizations to estimate the risk for the CG.

In determining compliance, the Commission would compare this estimate

with the risk limit in the standard.

We considered proposing the probabilistic CG approach but are not

doing so for the following reasons. First, there is no relevant

experience in applying the probabilistic CG approach. Second, the

approach is very complex and difficult to implement in a manner that

assures it would meet the requirements of defining a CG. Third, we are

concerned that this approach does not appear to identify clearly who is

being protected. Finally, a significant majority of the comments that

we have received upon the NAS Report opposes the probabilistic CG

approach.

The NAS subsistence-farmer critical group. The approach in Appendix

D of the NAS Report specified one or more subsistence farmers as the

CG. It made assumptions designed to define the farmer at maximum risk

to be included in the CG. This section describes the contents of

Appendix D of the NAS Report.

The subsistence-farmer CG is a definable, highly exposed segment of

the larger, exposed population. The subsistence farmer would be assumed

to: (1) be a person with eating habits and response to doses of

radiation that would be average for present-day people and (2) obtain

all potable water and grow all of his or her own food using water

withdrawn from the aquifer contaminated with radionuclides from the

disposal system. The water used by this CG would be withdrawn at a

location downgradient from and outside the footprint of the repository

at the point of maximum potential concentration of ground water

contamination, provided that no natural geologic features preclude

drilling for water at that location

own food using water

withdrawn from the aquifer contaminated with radionuclides from the

disposal system. The water used by this CG would be withdrawn at a

location downgradient from and outside the footprint of the repository

at the point of maximum potential concentration of ground water

contamination, provided that no natural geologic features preclude

drilling for water at that location. (The footprint of the repository

is the circumscription of the outermost, original emplacement locations

of the waste.)

Concentrations of radionuclides in the extracted ground water may

be smaller than in undisturbed ground water due to pumping; this

possibility could be used when evaluating exposures (NAS Report p.

155). As a result of uncertainty, there will be probabilistic

distributions of radionuclide concentrations, as they vary in time and

space in the aquifer outside the repository footprint, which are the

input variables needed to estimate the risk. The radionuclide

distributions in the aquifers, in turn, depend upon the performance of

the components of the natural and engineered barrier systems.

Projections of their performance also contain uncertainty and likely

will be subject to probabilistic assessment. Any assessment of the

potential doses from the repository, therefore, must consider the

probability of processes and events that influence eventual

concentrations of radionuclides in aquifers supplying water to the CG.

Overall, the ``expected'' risk for the average member of this CG

would be about one-half that of the most-exposed subsistence farmer

(NAS Report p. 158). This average risk to the members of the CG would

be compared with the standard selected for compliance.

We considered proposing that the protected individual(s) be the

subsistence-farmer CG. The CG concept has been utilized within the U.S.

in various ways. The NRC uses the CG concept in assessing compliance

with NRC standards for radionuclide releases from nuclear facilities

S Report p. 158). This average risk to the members of the CG would

be compared with the standard selected for compliance.

We considered proposing that the protected individual(s) be the

subsistence-farmer CG. The CG concept has been utilized within the U.S.

in various ways. The NRC uses the CG concept in assessing compliance

with NRC standards for radionuclide releases from nuclear facilities.

For example, the Commission uses the CG concept in: (1) licensing

actions involving dose calculations under 10 CFR part 40, appendix A;

(2) its radiological criteria for license termination of all NRC-

licensed facilities at 10 CFR part 20, subpart E; and (3) its draft

guidance for LLW disposal under 10 CFR part 61. The State of Washington

recently

implemented the CG concept in actions relating to U.S. Ecology's LLW

site at Hanford, and the State of Texas endorses CG in its

decommissioning standards. Also, a great deal of international guidance

exists that discusses the use of CG. The ICRP endorses CG, and has

recommended the CG concept in numerous documents, both recent and

dating back as far as 1977. Canada, Sweden, Switzerland, and the United

Kingdom are among those individual nations that have adopted the CG

methodology for radioactive waste storage and disposal.

We prefer an approach to exposure assessment that is consistent

with other Agency programs (Guidance on Risk Characterization for Risk

Managers and Risk Assessors, Deputy Administrator F. Henry Habicht II,

February 26, 1992) and which we believe provides a level of protection

substantially equivalent to that which would be achieved by the CG

concept.

Our proposal for the protection of individuals. Most of our

programs use an approach for the development of exposure scenarios that

involves determining the high-end range of doses or exposures.

Conceptually, this range is that above the 90th percentile of the

entire (either measured or estimated) distribution of potential doses

within the exposed population

d be achieved by the CG

concept.

Our proposal for the protection of individuals. Most of our

programs use an approach for the development of exposure scenarios that

involves determining the high-end range of doses or exposures.

Conceptually, this range is that above the 90th percentile of the

entire (either measured or estimated) distribution of potential doses

within the exposed population. Conversely, the NESHAPs program for

radionuclides and the individual-protection requirements in the generic

SNF and HLW disposal standards at 40 CFR 191.15 require calculation of

the individual dose for a person assumed to reside at a location where

that person would receive the highest dose. However, other Agency

programs use a different approach to protect individuals by using

``reasonable, maximum exposure'' (RME) conditions. The National

Contingency Plan describes an approach to be used for the RME scenario

to protect individuals as ``a product of factors, such as concentration

and exposure frequency and duration, that are an appropriate mix of

values that reflect averages and 95th percentile distributions'' (55 FR

8666, 8710, March 8, 1990). In the past, we have defined ``reasonable

maximum'' to mean potential exposures that are likely to occur. The

method for calculating the RME is to estimate the high-end range of

possible exposures by identifying the factors which have the greatest

effect upon the size of the dose, and using maximum or nearly maximum

values for one or a few of these factors, leaving the others at their

average values (57 FR 22888, 22922, May 29, 1992). In this approach, we

select a hypothetical individual who would be representative of the

most highly exposed individuals. We call this individual the reasonably

maximally exposed individual (RMEI). To be effective, the RMEI approach

must avoid incompatible combinations of parameter values, such as, low

body weight used in combination with high intakes

alues (57 FR 22888, 22922, May 29, 1992). In this approach, we

select a hypothetical individual who would be representative of the

most highly exposed individuals. We call this individual the reasonably

maximally exposed individual (RMEI). To be effective, the RMEI approach

must avoid incompatible combinations of parameter values, such as, low

body weight used in combination with high intakes.

Thus, we intend for this procedure to project doses that are within

a reasonably expected range rather than projecting the most extreme

case. However, the procedure is also meant to identify an individual

dose which is well above the average dose in the exposed population.

The ultimate goal and purpose is to estimate a level of exposure that

is protective of the vast majority of individuals at a site, but is

still within a reasonable range of potential exposures.

For the preceding reasons, we are proposing the RMEI concept as our

preferred approach instead of the CG approach. The United States and

other countries have used the concept of a hypothetical individual to

represent future populations in radioactive-waste management programs.

This is consistent with widespread practice, current and historical, of

estimating dose and risk to highly exposed individuals even when the

exposure habits of future people cannot be specified or accurately

calculated, as in this case where doses must be projected for very long

periods. The approach is straightforward and relatively simple to

understand. We believe that this approach provides protection similar

to that afforded by the NAS recommendation to use a CG. The RMEI model

uses a series of assumptions about the lifestyle of a hypothetical

individual. The desired degree of conservatism can be built into the

model through choices of assumed values of RME parameters. However,

these values would be within certain limits since we are proposing to

require the use of Yucca Mountain-specific characteristics in choosing

those parameters and their values

The RMEI model

uses a series of assumptions about the lifestyle of a hypothetical

individual. The desired degree of conservatism can be built into the

model through choices of assumed values of RME parameters. However,

these values would be within certain limits since we are proposing to

require the use of Yucca Mountain-specific characteristics in choosing

those parameters and their values. In subpart B of 40 CFR part 197, we

propose a framework of assumptions for NRC to incorporate into its

implementing regulations.

Our proposed RMEI would be representative of a future population

group termed ``rural-residential.'' The CEDE received by this RMEI

would be calculated by DOE using cautious, but reasonable, exposure

parameters and parameter-value ranges. The projected CEDE would be used

by NRC in the determination of compliance with the proposed standards.

We believe that the results obtained by using this approach would be

similar to those which would be obtained by using the subsistence-

farmer CG approach put forth in Appendix D of the NAS Report. In both

cases, the objective is to determine the magnitude of the potential

exposure using reasonable, not extreme, assumptions. Under the proposed

standards, the RMEI will have food and water intake rates, diet, and

physiology like that of individuals currently living in the

downgradient direction of flow of the ground water passing under Yucca

Mountain. The Department will perform the dose calculation to estimate

exposure resulting from releases from the waste into the accessible

environment based upon the assumption of present-day conditions in the

vicinity of Yucca Mountain. Presently, we expect the ground water

pathway to be the most significant pathway for exposure from

radionuclides that are transported from the repository

ca

Mountain. The Department will perform the dose calculation to estimate

exposure resulting from releases from the waste into the accessible

environment based upon the assumption of present-day conditions in the

vicinity of Yucca Mountain. Presently, we expect the ground water

pathway to be the most significant pathway for exposure from

radionuclides that are transported from the repository. Our initial

evaluation of potential exposure pathways from the disposal system to

the RMEI suggests that the dominant fraction of the dose incurred by

the RMEI likely will be from ingestion of food irrigated with

contaminated water (see the BID). It is possible, however, that another

exposure pathway will be determined by DOE and NRC to be more

significant for radiation exposure. Consequently, DOE and NRC must

consider and evaluate all potentially significant exposure pathways in

the performance assessment. As a result of the performance assessment,

there will be a distribution of the highest potential doses incurred by

the RMEI. We are proposing that the mean or median value (whichever is

higher) of that distribution be used by NRC to determine compliance

with the individual-protection standard. We request comments upon this

method of determining compliance with the individual-protection

standard.

We are also requesting comments upon the alternative of adopting

the CG approach rather than the RMEI. Comments supporting the CG

approach should address the level of detail EPA's rule should include

on the parameters of the CG.

Exposure scenario for the RMEI. A major part of the exposure

scenario is the location of the RMEI. In preparing to propose a

location for the RMEI, we collected and evaluated information on the

natural geologic and hydrologic features, such as topography, geologic

structure, aquifer depth, aquifer quality, and the quantity of ground

water, that may preclude drilling for water at a specific location

re scenario for the RMEI. A major part of the exposure

scenario is the location of the RMEI. In preparing to propose a

location for the RMEI, we collected and evaluated information on the

natural geologic and hydrologic features, such as topography, geologic

structure, aquifer depth, aquifer quality, and the quantity of ground

water, that may preclude drilling for water at a specific location.

Based upon these factors and the current understanding of ground water

flow in the area of Yucca

Mountain, it appears that an individual could reside anywhere along the

projected radionuclide flow path extending from Forty-Mile Wash,

approximately five kilometers (km) from the proposed repository

location, to the southwestern part of the Town of Amargosa Valley,

Nevada, where the ground water is close to the land surface and where

most of the farming in the area is done. However, an individual's

ability to reside at any particular point along that path depends upon

that individual's purpose and available resources. To explore these

variations, we developed the four scenarios described below. We present

our evaluation of factors associated with these scenarios more fully in

the BID. We welcome comment upon the appropriateness of each of these

scenarios and upon our preferred scenario. In developing scenarios, we

assumed that the level of technology and economic considerations

affecting population distributions and life styles in the future are

the same as today (for more detail, see the What Should Be Assumed

about the Future Biosphere? section below).

The RMEI in the first scenario is a subsistence (low technology)

farmer. Such an individual would have continuous exposure to

radionuclides in water, air, and soil which are arriving through all

exposure pathways

affecting population distributions and life styles in the future are

the same as today (for more detail, see the What Should Be Assumed

about the Future Biosphere? section below).

The RMEI in the first scenario is a subsistence (low technology)

farmer. Such an individual would have continuous exposure to

radionuclides in water, air, and soil which are arriving through all

exposure pathways. The RMEI's location and habits would be generally

consistent with historical locations of Native Americans and early

settlements in Amargosa Valley and influenced heavily by easy access to

water, that is, where the water table is near the surface

(approximately 30-40 km away from the disposal system). In addition,

all of the RMEI's water and food would come from contaminated sources.

We did not choose this option because we believe that such a scenario

is overly conservative given the site-specific characteristics of the

area and reasonable consideration of the lifestyles of individuals in

that area.

In the second scenario, we considered using a commercial farmer as

the RMEI. We evaluated economic factors and current and potential

future technologies which could be economically viable. There are areas

in the vicinity of Yucca Mountain which are currently being farmed

commercially or could be economically farmed based upon reasonable

assumptions, current technology, and experience in other arid parts of

the western United States. The exposure pathways in this scenario would

be the same as those used for the subsistence-farmer scenario. We did

not choose this as our preferred scenario since we believe that

commercial farming would not be representative of the general

population and would not be likely in areas other than where there is

currently such farming, approximately 30 kilometers from the disposal

system.

The third scenario, selected as our preferred approach, involves a

rural-residential RMEI

tence-farmer scenario. We did

not choose this as our preferred scenario since we believe that

commercial farming would not be representative of the general

population and would not be likely in areas other than where there is

currently such farming, approximately 30 kilometers from the disposal

system.

The third scenario, selected as our preferred approach, involves a

rural-residential RMEI. We assume that the rural-residential RMEI is

exposed through the same general pathways as the subsistence farmer.

However, this RMEI would not be a full-time farmer but would do

personal gardening and earn income from other sources of work in the

area. We assume further that all of the drinking water (two liters per

day) and some of the food consumed by the RMEI is from the local area.

The consumption of two liters per day of drinking water is a high value

since people consume water from outside sources, such as commercial

products. Similarly, we assume that local food production will use

radioactively contaminated water coming from the disposal system. We

believe this lifestyle is similar to that of most people living in

Amargosa Valley today.

The fourth scenario which we considered is domestic use of an

underground source of drinking water (USDW) by a community living near

the repository site. A USDW is essentially an aquifer which is large

enough to supply or could supply a public water system (the full

definition is in 40 CFR 144.3). Based upon current water usage in the

arid western United States, a public water supply inside of the current

NTS could exist since a community would have greater resources to

access and recover water than would most individuals. Such a community

water supply would have characteristics similar to DOE's water wells J-

12 and J-13. These wells have supplied water needs (including human

consumption) since the early 1960s for the Federal government

nited States, a public water supply inside of the current

NTS could exist since a community would have greater resources to

access and recover water than would most individuals. Such a community

water supply would have characteristics similar to DOE's water wells J-

12 and J-13. These wells have supplied water needs (including human

consumption) since the early 1960s for the Federal government. While we

consider such a scenario possible, it could be less protective than the

rural-residential scenario because it would not protect individuals

from the ingestion of contaminated home-grown food. Also, we consider

this scenario less representative of current conditions for most people

in the vicinity of Yucca Mountain.

Location of the RMEI. The location of the RMEI is a basic part of

the exposure scenario. We considered locations within a region

occupying an area bordering Forty-Mile Wash, within a few kilometers of

the repository site, to the southwestern border of the Town of Amargosa

Valley. This region, which we believe is hydrologically downgradient

from Yucca Mountain, can be considered as three general subareas.

The first subarea occupies the land south from near Yucca Mountain

to the vicinity of U.S. Route 95. This subarea has deep ground water

(up to about 300 meters) which is accessed by Federally owned wells

used for DOE activities associated with Yucca Mountain and the NTS.

This land is currently under government control and ownership. In

addition, the likelihood of small or economically viable agricultural

activities in this area is questionable when the depth to the water

table is taken into consideration.

The next subarea borders the first and extends several kilometers

south of U.S. Route 95. The northern portion of the Town of Amargosa

Valley, including the businesses at the intersection of U.S. Route 95

and Nevada State Route 373 (Lathrop Wells), is included in this

subarea

agricultural

activities in this area is questionable when the depth to the water

table is taken into consideration.

The next subarea borders the first and extends several kilometers

south of U.S. Route 95. The northern portion of the Town of Amargosa

Valley, including the businesses at the intersection of U.S. Route 95

and Nevada State Route 373 (Lathrop Wells), is included in this

subarea. This subarea currently includes about 15 residents and no

agricultural activities, although abandoned irrigation wells exist (see

the BID). The depth to water in this area ranges from slightly more

than 100 to about 60 meters. The U.S. Natural Resource Conservation

Service has designated the types of soils in this area as suitable for

rangeland and wildlife habitat.

The third subarea borders the second and covers the remainder of

the Town of Amargosa Valley. This subarea is the closest downgradient

location to Yucca Mountain with perennial agricultural activity. The

depth to ground water is relatively shallow--approximately 50 to 15

meters. The agriculture consists of both personal gardens and

commercial activities. The commercial agriculture is a mainstay of the

local economy. Commercial farms produce crops, livestock, and dairy

products for either local consumption or for transport out of the

region. Most of the residents of the Town of Amargosa Valley are within

this subarea, as are the community center, school, clinic, library,

post office, and sheriff's office. The population consists of all age

groups.

Based upon these considerations of the subareas, we propose that

the intersection of U.S. Route 95 and Nevada State Route 373, known as

Lathrop Wells, is a likely location for the RMEI. In this example, we

do not consider it probable that the rural-residential RMEI would

occupy locations significantly north of U.S. Route 95

ce, and sheriff's office. The population consists of all age

groups.

Based upon these considerations of the subareas, we propose that

the intersection of U.S. Route 95 and Nevada State Route 373, known as

Lathrop Wells, is a likely location for the RMEI. In this example, we

do not consider it probable that the rural-residential RMEI would

occupy locations significantly north of U.S. Route 95. We make this

assumption mainly because the rough terrain and increasing depth to

ground water nearer to Yucca Mountain would likely discourage

settlement by individuals because access to water is more difficult

than it would be a few kilometers

farther south. Also, there are currently several residents and

businesses near this location whose source of water is the underlying

aquifer (which we understand flows from under Yucca Mountain).

Therefore, we believe that it is reasonable to assume that individuals

could reside near this intersection in the future.

Farming occurs today farther south, in the southwestern portion of

the Town of Amargosa Valley in an area near the California border and

west of Nevada State Route 373. However, soil conditions in the

vicinity of Lathrop Wells are similar to those in southwestern Amargosa

Valley. Therefore, it should be feasible for the RMEI to grow some of

his or her own food, including a grazing cow, using a fraction of the

water recovered but not used for household purposes. Larger-scale food

production at Lathrop Wells is unlikely because of the cost of

recovering sufficient water. To supplement the gardening and grazing,

we propose that it is also reasonable to assume that the RMEI would

obtain much of his or her food from the local area.

Finally, we believe that a rural-residential RMEI near Lathrop

Wells would be among the most highly exposed individuals in the

downgradient direction from Yucca Mountain

is unlikely because of the cost of

recovering sufficient water. To supplement the gardening and grazing,

we propose that it is also reasonable to assume that the RMEI would

obtain much of his or her food from the local area.

Finally, we believe that a rural-residential RMEI near Lathrop

Wells would be among the most highly exposed individuals in the

downgradient direction from Yucca Mountain. We believe that this is

true even though individuals residing closer to the repository (where

the ground water is at a greater depth) could be consuming higher

concentrations of radionuclides in their drinking water. Because of the

significant cost of finding and withdrawing the ground water, we

further believe that individuals living nearer the repository are

unlikely to withdraw water from the significantly greater depth and in

the much larger quantities needed for farming activities. Based upon

our analyses of potential pathways of exposure, discussed above, we

believe that irrigation would be the most likely pathway for most of

the dose from the most soluble, least retarded radionuclides (such as

technetium-99 and iodine-129). The percentage of the dose that results

from irrigation would depend upon the assumptions about the fraction of

all food assumed to be consumed by the RMEI from gardening or other

crops grown using contaminated water. We also are proposing that

protection of a rural-residential RMEI would be protective of the

general population (see the How Will the General Population Be

Protected? section below).

Our identification of Lathrop Wells as a potential location of the

RMEI is based upon a review of available, site-specific information. Of

course, DOE and NRC must consider other, more appropriate locations

based upon additional data which DOE or others may develop later, but

the selection of that other location must be based upon the same

considerations used for this example

section below).

Our identification of Lathrop Wells as a potential location of the

RMEI is based upon a review of available, site-specific information. Of

course, DOE and NRC must consider other, more appropriate locations

based upon additional data which DOE or others may develop later, but

the selection of that other location must be based upon the same

considerations used for this example. For example, if DOE subsequently

determines that the direction of ground water flow is different than we

have assumed, DOE and NRC must choose the location, at the same

distance from the center of the repository footprint as the original

point of compliance, where the highest radionuclide concentrations

occur.

As stated earlier, the method of calculating the RME is to select

average values for most parameters except one or a few which are set at

their maximum, that is, high-end, values. We believe that the Lathrop

Wells location and a consumption rate of two liters per day of drinking

water from the plume of contamination represent high-end values for two

of these factors. The Commission may identify additional parameters for

which to assign high-end values in projecting the dose to the RMEI. To

the extent possible, NRC should use site-specific information for any

remaining factors. For example, NRC should use the most accurate

projections of the amount of contaminated food that would be ingested

in the future. Projections might be based upon surveys which indicate

the percentage of the total diet of Amargosa Valley residents which is

from food grown in the Amargosa Valley area.

We particularly request comment upon whether:

(1) Based upon the above criteria, there is now sufficient

information for us to adequately support a choice for the RMEI location

in the final rule or should we leave that determination to NRC in their

licensing process based upon our criteria;

(2) Another location in one of the three subareas identified

previously should be the location of the RMEI; and

ularly request comment upon whether:

(1) Based upon the above criteria, there is now sufficient

information for us to adequately support a choice for the RMEI location

in the final rule or should we leave that determination to NRC in their

licensing process based upon our criteria;

(2) Another location in one of the three subareas identified

previously should be the location of the RMEI; and

(3) Lathrop Wells and an ingestion rate of two liters per day of

drinking water are appropriate high-end values for parameters to be

used to project the RME. We also request comment upon the potential

approaches and assumptions for the exposure scenario to be used for

calculating the dose incurred by the RMEI.

III.B.5. How Will the General Population be Protected?

In section 801(a)(2)(A) of the EnPA, Congress asked whether an

individual-protection standard could also protect the general

population. In response, the NAS concluded that an individual-

protection standard could provide such protection for the case of the

proposed Yucca Mountain repository. The NAS premised this conclusion

upon the condition that the public and policymakers would accept the

idea that extremely small individual radiation doses spread out over

large populations pose a risk that is negligible (NAS Report p. 57).

The NAS refers to this concept as ``negligible incremental risk'' (NAS

Report p. 59). Earlier, we described our proposed individual-protection

standard for the RMEI which would establish the highest allowable

radiation dose. This section of the notice raises another question--

should we also adopt a standard to limit the possible widespread

exposure of whole populations to extremely small individual doses?

In discussing the feasibility of protecting the general population

from releases of radionuclides from Yucca Mountain, NAS considered the

potential for the release of gaseous radionuclides

wable

radiation dose. This section of the notice raises another question--

should we also adopt a standard to limit the possible widespread

exposure of whole populations to extremely small individual doses?

In discussing the feasibility of protecting the general population

from releases of radionuclides from Yucca Mountain, NAS considered the

potential for the release of gaseous radionuclides. The NAS Report

explained how the release of carbon dioxide gas containing \14\ C from

the Yucca Mountain disposal system might expose a large population:

Global populations might be affected because radionuclide

releases from a repository can in theory be diffused throughout a

very large and dispersed population. In the case of Yucca Mountain,

the likely pathway leading to widely dispersed radionuclides is via

the atmosphere beginning with release of carbon dioxide gas

containing the carbon-14 (\14\ C) radioactive isotope which might

escape from the waste canisters. (NAS Report p. 7)

On page 61 of its Report, NAS estimated that the average dose to

members of the global population, based upon this scenario, to be 0.003

Sv/year (0.0003 mrem/yr) and equated that to an annual risk of

fatal cancer of 1.5 in 10 billion (1.5 x 10-10).

The NAS relied upon the recommendations of the NCRP in its report

titled ``Limitation of Exposure to Ionizing Radiation'' (NCRP Report

No. 116) to support their claim that such doses are negligibly small.

In this report, the NCRP stated that a radiation dose of less than 10

Sv (1 mrem)/yr for any source or practice would represent a

``negligible incremental dose.'' The NCRP endorsed the assumption that

there is some radiation risk for every radiation exposure. Further,

they explained that there are great uncertainties in trying to

understand the meaning of radiation effects upon populations,

especially when these effects are calculated by summing extremely small

individual doses among huge populations. Agreeing with this

``negligible incremental dose.'' The NCRP endorsed the assumption that

there is some radiation risk for every radiation exposure. Further,

they explained that there are great uncertainties in trying to

understand the meaning of radiation effects upon populations,

especially when these effects are calculated by summing extremely small

individual doses among huge populations. Agreeing with this

concept, the NAS preferred to use risk instead of dose. The NAS then

estimated the risk level associated with the NCRP's NID level of 10

Sv/yr and adopted the term ``negligible incremental risk.''

The NAS then proposed this NIR level as the starting point for a

process to establish a risk level for individuals that would be

``negligible.''

For different reasons, we provisionally agree with the NAS that an

individual-risk standard can adequately protect the general population

near Yucca Mountain. Our agreement is based upon the particular

characteristics of the Yucca Mountain site. We emphasize that our view

relates to the specific circumstances associated only with Yucca

Mountain. We are not proposing to adopt either an NID or NIR level. We

are concerned that such an approach is not appropriate in all

circumstances. Again, our proposed determination that an individual-

risk standard is adequate to protect both the local and general

population is based upon considerations unique to the Yucca Mountain

site--it is not a general policy judgment by us upon other uses of the

concept of NID or NIR.

We considered the NAS suggestion to adopt a general NIR level but

have not done so because of reservations regarding the reasoning and

analysis employed by NAS. As noted above, NAS referred to the NID level

of 10 Sv (1 mrem)/yr per source or practice recommended by the

NCRP. The International Atomic Energy Agency (IAEA) has made similar

recommendations regarding exemptions in its Safety Series No

onsidered the NAS suggestion to adopt a general NIR level but

have not done so because of reservations regarding the reasoning and

analysis employed by NAS. As noted above, NAS referred to the NID level

of 10 Sv (1 mrem)/yr per source or practice recommended by the

NCRP. The International Atomic Energy Agency (IAEA) has made similar

recommendations regarding exemptions in its Safety Series No. 89,

``Principles for the Exemption of Radiation Sources and Practices from

Regulatory Control.'' The IAEA has recommended that individual doses

not exceed 10 Sv (1 mrem)/yr from each exempt practice. The

IAEA's recommendations relate to criteria for exempting whole sources

or practices, such as waste disposal or recycling generally, not

whether radiation doses from a portion of a given practice, such as the

release of gases from a specific geologic repository, may be considered

negligible. Finally, the IAEA's recommendations intend their exemption

to be for sources and practices ``which are inherently safe.'' It is

not clear that the low individual doses or risks projected from gaseous

releases from the Yucca Mountain repository should be considered on

their own as a ``source'' or ``practice'' or that such a source or

practice should be considered inherently safe. Also, we believe it to

be inappropriate to not calculate a radiation dose merely because the

dose rate from a particular source is small.

Further, we are not sure it is appropriate to apply the NIR concept

to consideration of population dose. A recent NCRP report questions the

application of the negligible incremental dose (NID) concept to

consideration of population doses. According to NCRP Report No. 121:

``A concept such as the NID (Negligible Incremental Dose) provides a

legitimate lower limit below which action to further reduce individual

dose is unwarranted, but it is not necessarily a legitimate cut-off

dose level for the calculation of collective dose

the

application of the negligible incremental dose (NID) concept to

consideration of population doses. According to NCRP Report No. 121:

``A concept such as the NID (Negligible Incremental Dose) provides a

legitimate lower limit below which action to further reduce individual

dose is unwarranted, but it is not necessarily a legitimate cut-off

dose level for the calculation of collective dose. Collective dose

addresses societal risk while the NID and related concepts address

individual risk.'' Based upon this, we think it would be inappropriate

to use the negligible incremental dose or risk concept to evaluate

whether an individual-protection standard adequately protects the

general population.

Although we do not advocate use of the NID concept, we acknowledge

that the extremely low levels of individual risk and dose cited by NAS

as being associated with the release of \14\ C from Yucca Mountain are

many orders of magnitude below the levels at which we have regulated in

other circumstances. For example, we used the following policies under

the pre-1990 Clean Air Act (CAA) hazardous air pollution control

program: (1) provide public health protection for the greatest number

of persons possible based upon a lifetime (70 years) risk level no

higher than approximately 1 x 10-6 for an individual, and

(2) limit the maximum, individual-lifetime, estimated risk to no higher

than 1 in 10,000 (1 x 10-4) (54 FR 51654, 51655, December

15, 1989). Even though we adopted this approach in a different policy

context, it provides insight into how we have dealt with similar risk-

management issues in a regulatory context. In 1990, Congress amended

the CAA to require us to develop technology-based standards to reduce

emissions. At the same time, Congress authorized us to delete

categories of sources from regulation if no source in that category

could cause a lifetime risk of cancer exceeding 1 x 10-6 for

the most-exposed individual in the population

with similar risk-

management issues in a regulatory context. In 1990, Congress amended

the CAA to require us to develop technology-based standards to reduce

emissions. At the same time, Congress authorized us to delete

categories of sources from regulation if no source in that category

could cause a lifetime risk of cancer exceeding 1 x 10-6 for

the most-exposed individual in the population. The risk over an

individual's lifetime from exposure to gaseous \14\ C released from the

Yucca Mountain repository, as estimated by NAS, would be about 100

times lower than 10-6. This particular risk level is

extremely low and well below the risk level that we generally regulate.

The disposal standards in 40 CFR part 191 include release limits

(or containment requirements) to protect populations and an individual-

protection standard. We rejected adopting only an individual-protection

standard in those standards because of a concern that an individual-

dose limitation alone might encourage selection of disposal sites that

relied upon dilution of radionuclides at the expense of increased

overall population exposures. Specifically, we were concerned that, in

the absence of release limits, ``disposal sites near bodies of surface

water or large sources of ground water might be preferred--which the

Agency believes is an inappropriate policy that would usually increase

overall population exposures'' (50 FR 38066, 38078, September 19,

1985). For example, it is possible to have a site that could meet the

150 Sv (15 mrem)-CEDE/yr individual-protection standard while

still having large numbers of people being exposed to radiation levels

just below the standard. This scenario could result in significant

numbers of calculated health effects for each generation exposed and

very large numbers of calculated health effects over the regulatory

period. We believe that the policy embodied in the generic 40 CFR part

191 disposal standards is sound

n standard while

still having large numbers of people being exposed to radiation levels

just below the standard. This scenario could result in significant

numbers of calculated health effects for each generation exposed and

very large numbers of calculated health effects over the regulatory

period. We believe that the policy embodied in the generic 40 CFR part

191 disposal standards is sound. The provisions in 40 CFR part 191,

which could apply to a variety of potential disposal sites, should

discourage reliance upon dilution of radionuclides in the general

environment as a disposal method.

However, the potential for large-scale dilution of radionuclides,

through ground water and into surface water, as modeled in the

supporting analyses for 40 CFR part 191, does not exist at Yucca

Mountain, thereby minimizing the need for the kind of population-

protection requirements found in 40 CFR part 191. Rather, DOE plans to

locate the Yucca Mountain repository in an unsaturated rock formation

with limited amounts of infiltrating water passing through it and into

the underlying tuff aquifer. (``Unsaturated'' means that the rock could

absorb more water than it is holding.) That aquifer is, in turn, within

a ground water system which discharges into arid areas having high

evaporation rates and very little surface water. In other words, we

believe that the characteristics of the saturated zone under Yucca

Mountain are such that dilution from other sources will be limited and

the aquifer does not discharge into any large bodies of surface water.

Therefore, our basis for inclusion of a population-protection

requirement in 40 CFR part 191 does not appear to apply to the

development of site-specific standards for Yucca Mountain.

e

believe that the characteristics of the saturated zone under Yucca

Mountain are such that dilution from other sources will be limited and

the aquifer does not discharge into any large bodies of surface water.

Therefore, our basis for inclusion of a population-protection

requirement in 40 CFR part 191 does not appear to apply to the

development of site-specific standards for Yucca Mountain.

In addition, we based the release limits in 40 CFR part 191 partly

upon technology and partly upon risk levels which we believed to be

acceptably small. The technology basis for the release limits was based

upon assessments of repository performance of several generic disposal

systems, including one located in tuff. In finalizing 40 CFR part 191,

we stated:

[T]he rule cannot be interpreted as setting precedents for

``acceptable risk'' levels to future generations that should not be

exceeded regardless of the circumstances. Instead, because of a

number of unique circumstances, the Agency has been able to develop

standards for the management and disposal of these wastes that are

both reasonably achievable . . . and that limit risks to levels that

the Agency believes are clearly acceptably small. (50 FR 38066,

38070, September 19, 1985)

We developed these standards during the siting process mandated by the

NWPA in the 1980s. The inclusion of release limits pointed to the

importance of considering population doses during site selection. We

established the standards at a level that appeared to be reasonably

achievable for several types of rocks or geologic media and which would

keep risks to future populations acceptably small. The assessments we

performed in support of these generally applicable standards, however,

did not include a gaseous-release pathway similar to that described by

NAS for \14\ C because no one foresaw the potential importance of that

pathway at that time

d to be reasonably

achievable for several types of rocks or geologic media and which would

keep risks to future populations acceptably small. The assessments we

performed in support of these generally applicable standards, however,

did not include a gaseous-release pathway similar to that described by

NAS for \14\ C because no one foresaw the potential importance of that

pathway at that time. In fact, according to the generic analyses we

performed in support of 40 CFR part 191, the unsaturated site in tuff

was generally more protective, in terms of limiting total releases,

than the other geologic media we evaluated.

For these reasons, we do not believe that these generic analyses

and conclusions supporting the development of release limits in 40 CFR

part 191 are appropriate for judging the need for population-risk

limits or the acceptability of population risks from releases from

wastes in the Yucca Mountain disposal system. We are proposing to find

that the individual-protection standard is sufficient to protect public

health based upon the unique characteristics of the area around the

Yucca Mountain site.

In summary, we are proposing to adopt an individual-protection

standard for Yucca Mountain that will limit the annual radiation dose

incurred by the RMEI to 150 Sv (15 mrem) CEDE. At the same

time, we are not proposing to adopt a separate limit on radiation

releases for the purpose of protecting the general population, but we

are recommending that collective dose be estimated and considered (see

the following paragraph). We based this decision upon several factors.

The first factor is the NAS projection of extremely small doses to

individuals resulting from air releases from Yucca Mountain. That dose

level is well below the risk corresponding to our proposed individual-

protection standard for Yucca Mountain. It is also well below the level

that we have regulated in the past through other regulations

ragraph). We based this decision upon several factors.

The first factor is the NAS projection of extremely small doses to

individuals resulting from air releases from Yucca Mountain. That dose

level is well below the risk corresponding to our proposed individual-

protection standard for Yucca Mountain. It is also well below the level

that we have regulated in the past through other regulations. Further,

while we decline to establish a general NIR level, we do agree with NAS

that estimating the number of health effects resulting from a 0.0003

mrem/yr dose rate, in addition to the dose rate from background

radiation, in the general population is uncertain and controversial.

The second major factor is that, based upon current and site-specific

conditions near Yucca Mountain, there is not likely to be great

dilution resulting in exposure of a large population. In addition, we

are proposing additional ground water protection standards that would

establish specific limits to protect users of ground water and ground

water as a resource. Finally, we are still proposing to require that

all of the pathways, including air and ground water, would be analyzed

by DOE and considered by NRC under the individual-protection standard.

We request comment upon this approach. Commenters who disagree with

this approach should specifically address why it is inappropriate for

the Yucca Mountain disposal system and make suggestions about how we

might reasonably address this issue.

While we are not proposing to adopt additional regulatory

requirements for collective exposures of the general population from

releases from the Yucca Mountain disposal system, we urge DOE to

examine design alternatives for the disposal system, for the purpose of

reducing potential risk to the general population, in the National

Environmental Policy Act (NEPA) process for Yucca Mountain

sue.

While we are not proposing to adopt additional regulatory

requirements for collective exposures of the general population from

releases from the Yucca Mountain disposal system, we urge DOE to

examine design alternatives for the disposal system, for the purpose of

reducing potential risk to the general population, in the National

Environmental Policy Act (NEPA) process for Yucca Mountain. We received

public comments, in response to our request for comments regarding the

NAS Report, noting that DOE had already proposed, in its Notice of

Intent to prepare a NEPA-prescribed environmental impact statement

(EIS) for Yucca Mountain, to evaluate technical alternatives (60 FR

40167, August 7, 1995). In other words, DOE has previously proposed to

evaluate technical alternatives as part of its waste containment and

isolation strategy for Yucca Mountain (DOE, ``Strategy for Waste

Containment and Isolation for the Yucca Mountain Site,'' Preliminary

Review Draft, October 9, 1995). Thus, we recommend that DOE incorporate

these or similar considerations into its NEPA process to assess the

effectiveness of design alternatives to mitigate population exposures.

The following language provides context to the approach we consider

appropriate for calculating population exposure in the NEPA process. We

recommend that DOE calculate the collective dose without truncation and

with full consideration of the appropriate factors. This recommendation

is supported by a recent NCRP report upon the principles and

application of a collective dose in radiation protection (NCRP Report

No. 121). The NCRP advocated the use of collective dose for

optimization of protection and provided guidance on future exposures

from long-lived radionuclides, the situation that will likely exist at

Yucca Mountain:

of the appropriate factors. This recommendation

is supported by a recent NCRP report upon the principles and

application of a collective dose in radiation protection (NCRP Report

No. 121). The NCRP advocated the use of collective dose for

optimization of protection and provided guidance on future exposures

from long-lived radionuclides, the situation that will likely exist at

Yucca Mountain:

The most reasonable risk assessment that can be made for such

situations is to calculate potential individual doses for a range of

scenarios in order to: (1) evaluate protective measures and (2) to

try to place some boundaries on estimates of future individual

risks. For the few very long-lived radionuclides that are

metabolically regulated in the body and more or less uniformly

distributed within the biosphere (e.g., \14\ C and \129\ I), future

average individual doses may be estimated from total quantities in

the environment. . . . (NCRP Report No. 121, pp. 57-58)

III.B.6. What Should Be Assumed About the Future Biosphere?

We propose to require DOE and NRC to use the biosphere assumptions

described in this section in all analyses of repository performance,

including the performance assessment for determining compliance with

the individual-protection standard, the assessment for determining

compliance with the ground water standards, and the human-intrusion

analysis. Projecting biosphere conditions necessitates making

assumptions, many of which are very uncertain and may not be boundable.

The NAS stated:

In view of the almost unlimited possible future states of

society and of the significance of these states to future risk and

dose, . . . we have recommended that a particular set of assumptions

be used about the biosphere (including, for example, how and where

people get their food and water) for compliance calculations . . .

we recommend the use of assumptions that reflect current

technologies and living patterns. (NAS Report p. 122)

The NAS also stated:

and of the significance of these states to future risk and

dose, . . . we have recommended that a particular set of assumptions

be used about the biosphere (including, for example, how and where

people get their food and water) for compliance calculations . . .

we recommend the use of assumptions that reflect current

technologies and living patterns. (NAS Report p. 122)

The NAS also stated:

. . . unlike our conclusion about the earth science and geologic

. . . factors described [earlier], we believe that it is not

possible to

predict on the basis of scientific analyses the societal factors

that must be specified in a far-future exposure scenario. . . . Any

particular scenario about the future of human society near Yucca

Mountain . . . should not be interpreted as reflecting conditions

that eventually will occur. Although we recognize the burden on

regulators to avoid regulations that are arbitrary, we know of no

scientific method for identifying these [exposure] scenarios. (NAS

Report p. 96)

We agree with the NAS

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Environmental Radiation Protection Standards for Yucca Mountain, Nevada · 64 FR 46976 | Frix