[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Proposed Rules]
[Pages 6509-6527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02307]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 190

[EPA-HQ-OAR-2013-0689; FRL-9902-20-OAR]
RIN 2060-AR12


Environmental Radiation Protection Standards for Nuclear Power 
Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance Notice of Proposed Rulemaking.

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SUMMARY: This Advance Notice of Proposed Rulemaking (ANPR) requests 
public comment and information on potential approaches to updating the 
Environmental Protection Agency's ``Environmental Radiation Protection 
Standards for Nuclear Power Operations'' (40 CFR part 190). These 
standards, originally issued in 1977, limit radiation releases and 
doses to the public from normal operation of nuclear power plants and 
other uranium fuel cycle facilities--that is, facilities involved in 
the milling, conversion, fabrication, use and reprocessing of uranium 
fuel for generating commercial electrical power. These standards were 
the earliest radiation rules developed by EPA and are based on nuclear 
power technology and the understanding of radiation biology current at 
that time. The Nuclear Regulatory Commission (NRC) is responsible for 
implementing and enforcing these standards.

DATES: Comments must be received on or before June 4, 2014.
    Additional Public Input. In addition to this ANPR, the Agency 
anticipates providing additional opportunities for public input. Please 
see the Web site for more information at: www.epa.gov/radiation/laws/190.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2013-0689, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for 
submitting comments.
     Email: [email protected].
     Fax: (202) 566-9744.
     Mail: U.S. Postal Service, send comments to: EPA Docket 
Center, Environmental Radiation Protection Standards for Nuclear Power 
Operations--Advance Notice of Proposed Rulemaking Docket, Docket ID No. 
EPA-HQ-OAR-2013-0689, 1200 Pennsylvania Ave. NW., Washington, DC 20460. 
Please include a total of two copies.
     Hand Delivery: In person or by courier, deliver comments 
to: EPA Docket Center, Environmental Radiation Protection Standards for 
Nuclear Power Operations--Advance Notice of Proposed Rulemaking Docket, 
Docket ID No. EPA-HQ-OAR-2013-0689, EPA West, Room 3334, 1301 
Constitution Avenue NW., Washington, DC 20004. Such deliveries are only 
accepted during the Docket's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information. Please 
include a total of two copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2013-0689. The Agency's policy is that all comments received will be 
included in the public docket without change and may be made available 
online at www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through www.regulations.gov 
or email. The www.regulations.gov Web site is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an email comment directly to EPA without going through 
www.regulations.gov your email address will be automatically captured 
and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, EPA recommends that you include your name and other contact 
information in the body of your comment and with any disk or CD-ROM you 
submit. If EPA cannot read your comment due to technical difficulties 
and cannot contact you for clarification, EPA may not be able to 
consider your comment. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses. For additional information about the EPA's public docket, 
visit the EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the 
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
for which disclosure is restricted by statute. Certain other material, 
such as copyrighted material, will be publicly available only in hard 
copy. Publicly available docket materials are available either 
electronically in www.regulations.gov or in hard copy at the EPA Docket 
Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, 
DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
Docket Center is (202) 566-1742.

FOR FURTHER INFORMATION CONTACT: Brian Littleton, EPA Office of 
Radiation and Indoor Air, (202) 343-9216, [email protected].

SUPPLEMENTARY INFORMATION:

Fact Sheets

    The Agency is making several fact sheets available to assist the 
public in understanding the issues related to the effort to update this 
rule. These fact sheets are as follows:

1. ANPR Fact Sheet
2. Radiation Regulations Fact Sheet
3. Uranium Fuel Cycle Fact Sheet

    These fact sheets are available on the Agency's Web site associated 
with this effort at: www.epa.gov/radiation/laws/190.

Glossary of Terms

    What are the important radiation-related concepts and terms we use 
in this ANPR? Radiation-related terms used in this ANPR are defined 
below.
    Absorbed dose--The amount of energy absorbed by an object or person 
per unit mass. This reflects the amount of energy that ionizing 
radiation sources deposit in materials through which they pass.
    Advanced Boiling Water Reactor (ABWR)--New design of boiling water 
nuclear reactor which uses steam and high-pressure water to transfer 
energy to turbines. The NRC has detailed criteria for meeting this 
design in its design certification rule published in the Federal 
Register on May 12, 1997 (62 FR 25800).
    Advanced Passive Reactor 1000 (AP1000)--New design of pressurized 
water nuclear reactor with passive safety features incorporated. It 
uses high-pressure water to transfer energy to a second low-pressure 
water loop. This secondary water is converted to steam which then 
drives the turbines. The NRC has detailed criteria for meeting

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this design in its design certification rule published in the Federal 
Register on January 27, 2006 (71 FR 4464).
    Advanced Pressurized Water Reactor (APWR)--New design of 
pressurized water nuclear reactor which uses high-pressure water to 
transfer energy to a second low-pressure water loop. This secondary 
water is converted to steam, which then drives the turbines. The NRC 
has received the U.S. APWR design certification application and is 
reviewing the application for compliance with NRC's regulations. The 
NRC has not yet certified the design under its regulations at 10 CFR 
part 52. However, if the NRC determines that the U.S. APWR design meets 
all applicable regulations, it will proceed to certify the design 
through the NRC's rulemaking process.
    Blue Ribbon Commission (BRC)--The President's Blue Ribbon 
Commission on America's Nuclear Future was established as directed by 
the President's Memorandum for the Secretary of Energy dated January 
29, 2010. The purpose of the 15-member BRC was to conduct a 
comprehensive review of policies for managing the back end of the 
nuclear fuel cycle and recommend a new plan.
    Boiling Water Reactor (BWR)--A type of light-water nuclear reactor 
design which uses steam and high pressure water to transfer energy to 
turbines.
    Committed equivalent dose--The equivalent dose (see definition 
below) to a tissue or organ that will be received for a specified 
period of time following intake of radioactive material. The committed 
dose allows an accounting of the total dose from radioactive materials 
taken into (and held in) the body, for which the dose will be spread 
out in time, being gradually delivered as the radionuclide decays.
    Committed effective dose (CED)--The effective dose received over a 
period of time by an individual from radionuclides internal to the 
individual following a one-year intake of those radionuclides. CED is 
expressed in units of sievert (SI units) or rem.
    Collective dose--The sum of individual radiation doses to a 
specified group or population.
    Curie--A unit of radioactivity, corresponding to 3.7 x 10\10\ 
disintegrations per second.
    Deterministic effects--A health effect that has a clinical 
threshold (i.e., exposures below the threshold do not result in the 
effect of concern), beyond which the severity increases with the dose. 
Deterministic effects generally result from the receipt of a relatively 
high dose over a short time period. Radiation-induced cataract 
formation (clouding of the lens of the eye) is an example of a 
deterministic effect. These are also termed ``non-stochastic'' effects.
    Dose, or radiation dose--A general term for absorbed dose, 
equivalent dose, effective dose, committed effective dose, committed 
equivalent dose or total effective dose as defined in this document. A 
measure of the energy deposited in tissue by ionizing radiation.
    Dosimetry--The method used to calculate dose or other related 
measures of the impacts of exposure to radiation, taking into account 
the type of radiation and the duration and mode of exposure.
    Economic Simplified Boiling Water Reactor (ESBWR)--New design of 
boiling water nuclear reactor which uses high-pressure steam to 
transfer energy to turbines. It takes advantage of natural circulation 
for normal operation and has passive safety features.
    Effective dose (E)--This quantity, previously called the effective 
dose equivalent (EDE), is the weighted sum of the equivalent doses to 
individual organs of the body. The dose to each tissue or organ is 
weighted according to the risk that dose represents. These organ doses 
are then added together, and that total is the effective dose. The 
relevant units are rem or sieverts (SI units).
    Equivalent dose--The product of absorbed dose (grays or rads), 
averaged over a tissue or organ, multiplied by a radiation weighting 
factor. The radiation weighting factor relates to the degree to which a 
type of ionizing radiation will produce biological damage. It is used 
because some types of radiation, such as alpha particles, are more 
biologically damaging to live tissue than other types of radiation when 
the absorbed dose from both is equal. Equivalent dose expresses, on a 
common scale for all ionizing radiation, the biological damage to the 
exposed tissue. It is expressed numerically in rems (traditional units) 
or sieverts (SI units). This quantity was also known as the ``dose 
equivalent'' until the change in terminology was adopted by the 
International Commission on Radiological Protection (ICRP).
    Evolutionary Power Reactor (EPR)--New design of pressurized water 
nuclear reactor which uses high-pressure water to transfer energy to a 
second low-pressure water loop. This secondary water is converted to 
high-pressure steam which then drives the turbines.
    External dose--That portion of the dose equivalent received from 
radiation sources outside the body.
    High-level radioactive waste--The highly radioactive material 
resulting from the reprocessing of spent nuclear fuel, including liquid 
waste produced directly in reprocessing and any solid material derived 
from such liquid waste that contains fission products in sufficient 
concentrations; and other highly radioactive material that the NRC, 
consistent with existing law, determines by rule requires permanent 
isolation.
    Internal dose--That portion of the dose equivalent received from 
radioactive material taken into the body.
    International Commission on Radiological Protection (ICRP)--The 
independent, international advisory body that develops the 
international system of radiological protection as a common basis for 
standards, legislation, guidelines, programs and practices. 
Recommendations of the ICRP are not legally binding but are typically 
given strong consideration by individual countries as representing the 
state-of-the-art in radiation protection.
    Maximum Contaminant Level (MCL)--The highest level of a contaminant 
that EPA allows in drinking water.
    Mixed Oxide (MOX) Fuel--Fuel fabricated from mixed uranium and 
plutonium oxide, which may be used in reactors.
    Non-stochastic effects--Health effects, the severity of which 
varies with the dose and for which a threshold is believed to exist. 
Non-stochastic effects generally result from the receipt of a 
relatively high dose over a short time period. Also called 
deterministic effects.
    Oxidation, REduction of enriched OXide (OREOX) process--Fuel 
reprocessing technology which generates a mixed oxide fuel from spent 
nuclear fuel assemblies.
    Pressurized Water Reactor (PWR)--A type of light-water reactor 
which uses high pressure water to transfer energy to a second low 
pressure water loop. This secondary water is converted to high-pressure 
steam which then drives the turbines.
    Radionuclide Release Limits--In the context of this ANPR, the 
specific radionuclide release limits established under 40 CFR 
190.10(b). These are the legally permissible maximum amounts of 
krypton-85, iodine-129, as well as plutonium-239 and other alpha 
emitters that can enter the environment from the processes of nuclear 
power operations in any given year, on an energy production basis.
    Radiation effects--Health consequences from exposure to radiation. 
The effects may be either deterministic or stochastic.

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    Radiation risk--The probability or chance that a particular health 
effect will occur per unit dose of radiation.
    Rem--The traditional unit of effective dose. It is the product of 
the tissue-weighted absorbed dose in rads and a radiation weighting 
factor, WR, which accounts for the effectiveness of the 
radiation to cause biological damage; 1 rem = 0.01 Sv.
    Sievert (Sv)--The sievert is the International System of Units (SI) 
term for the unit of effective dose and equivalent dose; 1 Sv = 1 
joule/kilogram.
    Spent nuclear fuel reprocessing--The initial separation of spent 
nuclear fuel into its constituent parts.
    Spent nuclear fuel reprocessing facility--A building or complex of 
buildings where spent nuclear fuel reprocessing and other processes 
take place.
    Spent nuclear fuel storage--The storage of spent nuclear fuel from 
nuclear fuel cycle and power operations. Storage can include the 
temporary holding of spent nuclear fuel after it has been removed from 
the nuclear reactor, up to and including any storage of spent nuclear 
fuel prior to final disposal. On-site storage at a nuclear power plant 
may include the spent nuclear fuel pools, where the spent nuclear fuel 
is held immediately after removal from the reactor for several years of 
initial cooling, as well as subsequent storage, for example, in large 
concrete and metal dry storage casks and vaults. This term would also 
apply to storage at any potential facility designed for the storage of 
spent nuclear fuel prior to its final disposition.
    Stochastic effect (of radiation)--Malignant disease and heritable 
effects for which the probability of an effect occurring, but not its 
severity, is assumed to be a function of dose without threshold as a 
conservative planning base.
    TED (total effective dose)--The sum of the effective dose (for 
external exposures) and the committed effective dose (for internal 
exposures).
    Underground Source of Drinking Water (USDW)--An aquifer or part of 
an aquifer which (a) supplies any public water system or contains a 
sufficient quantity of ground water to supply a public water system and 
currently supplies drinking water for human consumption or contains 
fewer than 10,000 milligrams/liter of Total Dissolved Solids (TDS); and 
(b) is not an exempted aquifer (see 40 CFR 144.3 for a complete 
definition).

Table of Contents

I. Background
    A. What is the basis for the existing standards? How do the 
standards apply and what do they require?
    1. Statutory Authority
    2. History of the Standards
    3. Scope and Content of the Standards
    4. Technical Basis for the Standards
    B. Why is the Agency considering updating/revising the 
standards?
    1. What has changed and why could these changes be important?
    2. Guiding principles for review of existing standards
    C. What is the purpose of this ANPR and how will the Agency use 
the information?
    D. How can the public comment on the ANPR and get additional 
information?
II. Issues for Public Comment
    A. Issue 1: Consideration of a Risk Limit To Protect Individuals
    Should the Agency express its limits for the purpose of this 
regulation in terms of radiation risk or radiation dose?
    B. Issue 2: Updated Dose Methodology (Dosimetry)
    How should the Agency update the radiation dosimetry methodology 
incorporated in the standard?
    C. Issue 3: Radionuclide Release Limits
    Should the Agency retain the radionuclide release limits in an 
updated rule and, if so, what should the Agency use as the basis for 
any release limits?
    D. Issue 4: Water Resource Protection
    How should a revised rule protect water resources?
    E. Issue 5: Spent Nuclear Fuel and High-Level Radioactive Waste 
Storage
    How, if at all, should a revised rule explicitly address storage 
of spent nuclear fuel and high-level radioactive waste?
    F. Issue 6: New Nuclear Technologies
    What new technologies and practices have developed since 40 CFR 
part 190 was issued, and how should any revised rule address these 
advances and changes?
    G. Other Possible Issues for Comment
III. What will we do with this information?
IV. Statutory and Executive Order Reviews

I. Background

A. What is the basis for the existing standards? How do the standards 
apply and what do they require?

1. Statutory Authority
    Section 161(b) of the Atomic Energy Act of 1954 (AEA) authorized 
the Atomic Energy Commission (AEC) to ``establish by rule, regulation, 
or order, such standards and instructions to govern the possession and 
use of special nuclear material, source material, and byproduct 
material as the Commission may deem necessary or desirable to promote 
the common defense and security or to protect health or to minimize 
danger to life or property[.]'' 42 U.S.C. 2201(b) (1958). In 
Reorganization Plan No. 3 of 1970, President Nixon transferred to EPA 
``[t]he functions of the Atomic Energy Commission under the Atomic 
Energy Act of 1954, as amended, . . . to the extent that such functions 
of the Commission consist of establishing generally applicable 
environmental standards for the protection of the general environment 
from radioactive material.'' Sec.  2(a)(6), 35 FR 15623, 15624 (Oct. 6, 
1970) (``Reorganization Plan''). The Reorganization Plan defined 
``standards'' to mean ``limits on radiation exposures or levels, or 
concentrations or quantities of radioactive material, in the general 
environment outside the boundaries of locations under the control of 
persons possessing or using radioactive material.'' Id. This 
transferred to EPA the portion of the AEC's authority under AEA section 
161(b) that ``consist[ed] of establishing generally applicable 
environmental standards for the protection of the general environment 
from radioactive material.'' Reorganization Plan Sec.  2(a)(6); Quivira 
Mining v. U.S. Envt'l Prot. Agency, 728 F.2d 477, 480 (10th Cir. 1984) 
(recognizing that the Reorganization Plan transferred to EPA certain 
AEA functions under AEA Sec.  161(b)). Relying on this authority, EPA 
promulgated standards in 1977 to protect the public from exposure to 
radiation from the uranium fuel cycle at 40 CFR part 190, 
``Environmental Radiation Protection Standards for Nuclear Power 
Operations.''
2. History of the Standards
    On May 10, 1974, the Agency published an advance notice of its 
intent to propose standards under this authority for the uranium fuel 
cycle and invited public participation in the formulation of this 
proposed rule (39 FR 16906). On May 29, 1975, EPA proposed regulations 
setting forth such standards (40 FR 23420). The Agency promulgated the 
environmental radiation standards in final form in 1977 (42 FR 2860, 
January 13, 1977). The standards specify the levels of public exposure 
and environmental releases below which normal operations of the uranium 
fuel cycle are determined to be environmentally acceptable. These 
standards have not been revised since their initial publication.
3. Scope and Content of the Standards
    The existing standards apply to nuclear power operations, which are 
those operations defined to be associated with the normal production of 
electrical power for public use by any nuclear fuel cycle through 
utilization of nuclear energy. In 1977, the only nuclear fuel cycle in 
production within the U.S. was the uranium fuel cycle;

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thus, EPA developed specific standards for this industry. The uranium 
fuel cycle is defined as the operations of milling of uranium ore, 
chemical conversion of uranium, isotopic enrichment of uranium, 
fabrication of uranium fuel, generation of electricity by a light-
water-cooled nuclear power plant using uranium fuel, and reprocessing 
of spent uranium fuel to the extent that these directly support the 
production of electrical power for public use utilizing nuclear energy, 
but excludes mining operations, operations at waste disposal sites, 
transportation of any radioactive material in support of these 
operations, and the reuse of recovered non-uranium special nuclear and 
by-product materials from the cycle. (Commercial reprocessing has not 
occurred within the U.S. since the publication of the existing 
standards.) The Agency has developed some supporting information to 
help the public further understand the uranium fuel cycle which is 
located on the Agency's Web site for this rulemaking at www.epa.gov/radiation/laws/190. The existing standards do not address two other 
aspects of nuclear power production: The disposal of radioactive waste 
and the decommissioning of facilities.
    The regulation contains two main provisions: A dose limit to 
members of the public, and a radionuclide release limit to the 
environment. The provision specified in 40 CFR 190.10(a) limits the 
annual dose to any member of the public from exposures to planned 
releases from uranium fuel cycle facilities to 25 millirem (mrem) to 
the whole body, 75 mrem to the thyroid, and 25 mrem to any other organ. 
Additionally, the provision specified in 40 CFR 190.10(b) limits the 
total quantity of radioactive material releases for the entire uranium 
fuel cycle, per gigawatt-year of electrical energy produced, to less 
than 50,000 curies of krypton-85, 5 millicuries of iodine-129 and 0.5 
millicuries combined of plutonium-239 and other alpha-emitting 
transuranic radionuclides with half-lives greater than one year.
4. Technical Basis for the Standards
    The document Environmental Radiation Protection Requirements for 
Normal Operations of Activities in the Uranium Fuel Cycle: Final 
Environmental Statement (FES) (EPA Publication no. 520/4-76-016, 1976) 
provided the basis for developing 40 CFR part 190. This document states 
that at that time there were three fuels available for commercial 
nuclear power: Uranium-235, uranium-233 and plutonium-239. The first of 
these materials occurs naturally and the last two occur as products 
and/or by-products in uranium-fueled reactors (uranium-233 is the 
product of neutron irradiation of thorium-232). In the United States, 
the early development of technology for the nuclear generation of 
electric power focused around the light-water-cooled nuclear reactor 
(LWR), which utilizes uranium-235 fuel. For this reason, the standards 
considered only the use of enriched uranium-235 as fuel for the 
generation of electricity.
    Additionally, the EPA projected that well over 300,000 megawatts 
(300 gigawatts) of nuclear electric generating capacity would exist 
within the next twenty years.\1\ The part of the standards that pertain 
to the end of the fuel cycle relied on two assumptions: The 
availability of commercial nuclear reprocessing and the existence of a 
repository for final disposition for spent nuclear fuel and high-level 
radioactive wastes. The FES and supporting technical studies, which 
form the basis for the 40 CFR part 190 standards, include calculations 
of projected releases into the environment based on estimates of the 
growth of the nuclear industry. None of these assumptions has 
materialized.
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    \1\ The total current U.S. generating capacity is approximately 
101 gigawatts for 2010 based on data provided by U.S. Energy 
Information Administration: www.eia.gov/cneaf/nuclear/page/nuc_generation/gensum.html.
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B. Why is the Agency considering updating/revising the standards?

1. What has changed and why could these changes be important?
    The standards developed under 40 CFR part 190 were never intended 
to be static. The 1975 proposal (40 FR 23420, May 29, 1975) stated: 
``it is the intent of the Agency to maintain a continuing review of the 
appropriateness of these environmental radiation standards and to 
formally review them at least every five years and to revise them, if 
necessary, on the basis of information that develops in the interval.'' 
However, given the relatively limited change in the nuclear power 
industry in the intervening decades, we continued to believe that these 
standards remained protective of public health and the environment so 
we did not consider it necessary to update the standards. Nonetheless, 
we recognize that they do not reflect the most recent scientific 
information, and that this may be an opportune time to conduct a 
thorough review of their continued applicability. Therefore, the EPA is 
issuing this ANPR at this time for a number of reasons, including:
     Projected Growth of Nuclear Power. Growing concern about 
greenhouse gas emissions from fossil fuels has led to renewed interest 
in nuclear power. Nuclear energy emits very low levels of greenhouse 
gases, and unlike solar and wind power, provides a proven source of 
electricity capable of supplying a base-load that is not subject to 
varying weather conditions. The nuclear industry anticipates a demand 
for construction of several new nuclear power plants in the next 10 
years. Increased demand would likely result in the construction and 
start-up of any additional facilities to support the fuel cycle for 
LWRs. Other parts of the fuel cycle are experiencing growth as well. 
For example, new uranium enrichment facilities are coming on line, such 
as the facility in Eunice, New Mexico by Louisiana Enrichment Services 
(Urenco USA). The facility was licensed by the NRC in 2006, began 
operations in 2010, and is an indication of the industry's improved 
outlook. The licensing and operation of spent nuclear fuel reprocessing 
facilities are not expected in the near future.
     Advances in Radiation Protection and Dosimetry Science. 
National and international guidance on radiation protection have had 
three significant revisions since 40 CFR part 190 was issued. In the 
1980s, the organ dose-based system used in 40 CFR part 190 was replaced 
with a system that integrated organ doses into a single expression of 
dose, which employed mortality risk-based weighting factors such that 
the dose term was a surrogate for risk (International Commission on 
Radiological Protection (ICRP) Publications 26 and 30). This new 
approach allowed the use of one dose limit for all radionuclides taken 
into the body, as well as for external exposures. Individual dose 
factors were established for all radionuclides and weighting factors 
for various organs were risk-based. Numerous regulations used this 
methodology, including NRC's 10 CFR part 20, and EPA's 40 CFR part 61 
radionuclide emission standards. In addition, this methodology was used 
in EPA's internal and external dose factors in Federal Guidance Report 
Nos. 11 and 12. In the 1990s, ICRP improved the dosimetry models for 
ingestion and inhalation, expanded the number of organ-specific 
weighting factors and revised them to be based on new mortality and 
morbidity data. The risk factors in EPA Federal Guidance Report No. 13 
were based on this new dosimetry. In 2007, ICRP 103 was issued and the 
associated dosimetry is under development. In addition to improved

[[Page 6513]]

intake data and models, ICRP also addressed age- and gender-specific 
elements in the models. This information will be the basis for revising 
existing Federal Guidance Reports, which include radionuclide specific 
dose and risk factors.
     Advances in Radiation Risk Science. Advances in radiation 
risk science since 1977 have led to a better understanding of the 
health risks from ionizing radiation in general, as well as from 
specific radionuclides. Improved tools and methods for calculating 
radiation exposure have also become available. These advancements make 
more sophisticated radiological risk assessments possible. The Agency 
intends to review this standard to ensure its continued protectiveness 
in light of these advances. The Agency believes that the science used 
for the regulation is out of date and should be updated.
     On-site Storage of Spent Nuclear Fuel. The 1977 standards 
were based on the assumption that most spent nuclear fuel would be 
reprocessed following short-term storage on-site and that the U.S. 
would have a national repository for permanent disposal of high-level 
radioactive wastes and any remaining spent nuclear fuel in a time frame 
that would eliminate the need for longer-term storage. However, spent 
nuclear fuel currently is held at nuclear power plants in spent nuclear 
fuel storage casks or in storage pools as the U.S. determines a long-
term disposal solution. Increased interest in nuclear power has also 
raised the prospect of commercial reprocessing of spent nuclear fuel. 
Nevertheless, near-term projections indicate that spent nuclear fuel 
could remain on site at the power plants during the operational life of 
existing nuclear power plants and into (or beyond) the decommissioning 
phase. The President's Blue Ribbon Commission on America's Nuclear 
Future has also identified this as an issue, especially for 
decommissioned facilities.
     Extension of Nuclear Reactor Licenses. Many of the nuclear 
reactors in the U.S. were built in the 1960s and 1970s. These reactors 
either are approaching their initial 40-year operational license limit, 
or they have exceeded this time period and continue to operate under 
license renewals. Regardless of the age of the reactor (or other 
facility), any U.S. reactor would still need to meet the EPA standards.
     Ground Water. Ground water contamination has been 
identified at a number of nuclear power plants and nuclear fuel cycle 
facilities. The existing standard contains release limits that were 
intended to address the issue of long-lived radionuclides in the 
environment. However, the rule was developed under the assumption that 
air was the primary exposure pathway, and in contrast to more recent 
EPA radiation standards, it does not include a separate provision for 
protecting ground water outside facility boundaries that could be a 
current or future source of drinking water. The Agency is considering 
whether, and if so, how to develop a ground water provision.
2. Guiding Principles for Review of the Existing Standards
    This review of the existing standards has two key principles. The 
first is that a thorough assessment of the potential impact on public 
health should be based on an up-to-date consensus of currently 
available scientific knowledge. The second is that careful 
consideration should be given to the cost and effectiveness of measures 
available to reduce or eliminate radioactive releases to the 
environment. In the development of the existing standards, the Agency 
found it necessary to ``balance the health risks associated with any 
level of exposure against the costs of achieving that level'' (39 FR 
16906, May 10, 1974). The standard-setting method conducted in the 
current standards has been ``best characterized as cost-effective 
health risk minimization'' (Final Environmental Statement, 1976, Vol. 
1, p. 28). As the Agency considers these principles, we are committed 
to ensuring that any revision is based on current science to the extent 
practicable and remains protective of public health and the environment 
while seeking alternative ways (methodologies), within the Agency's 
authorities, to limit public exposure. The Agency may revise several of 
the technical criteria used as a basis for the existing regulation or 
add new criteria to the regulation.

C. What is the purpose of this ANPR and how will the Agency use the 
information?

    This Advance Notice of Proposed Rulemaking is being published to 
inform stakeholders, including federal and state entities, the nuclear 
industry, the public and any interested groups, that the Agency is 
reviewing the existing standards to determine how the standards should 
be updated. As noted earlier, EPA believes the existing standards 
remain protective of public health and the environment; however, the 
Agency also believes that the changes mentioned above are sufficient to 
warrant a review of the standards and solicit public input on possible 
updates. EPA has identified six broad topics that it believes capture 
the issues of most importance for a review of the existing standards. 
The Agency is requesting public comment on these specific topics; 
however, members of the public are welcome to comment on other aspects 
related to the nuclear fuel cycle that they believe EPA should 
consider.
    If the Agency decides to revise the existing standards, then the 
Agency would follow the procedures outlined in the AEA and the 
Administrative Procedure Act (APA) and publish a proposed rule in the 
Federal Register. Comments received on the ANPR will inform the 
development of a proposed rule and be used by the Agency to provide a 
clearer understanding of science, technology and other concerns and 
perspectives of stakeholders. The Agency will not respond directly to 
comments submitted on this ANPR. However, the public would have the 
opportunity to submit written comments on any proposed rule that might 
be developed.

D. How can the public comment on the ANPR and get additional 
information?

    The Agency welcomes comments on this ANPR as it reviews the 
existing standards. EPA has set up a Web site for the public to access 
the most up-to-date information regarding our review of these 
standards. This site contains detailed information related to this rule 
and any potential revision, including: a copy of the existing 
standards, copies of the Final Environmental Statements and the 
Supplemental Environmental Statement on which the existing standards 
are based, as well as related fact sheets.
    EPA plans to conduct public webinars to discuss specific issues on 
which the Agency is seeking comment. Dates, times and presentation 
materials for the webinars will be available on the Web site at: 
www.epa.gov/radiation/laws/190.

II. Issues for Public Comment

A. Issue 1--Consideration of a Risk Limit To Protect Individuals. 
Should the Agency express its limits for the purpose of this regulation 
in terms of radiation risk or radiation dose?

1. Why is this issue important?
    The purpose of the 40 CFR part 190 environmental standards is to 
protect human health and the environment. Although the current 
compliance metric for worldwide radiation standards is, and 
traditionally has been, either radiation dose or some measurable 
concentration or activity level, the Agency desires feedback to 
determine the feasibility of expressing its limits for

[[Page 6514]]

the purpose of this regulation in terms of radiation risk.
    Conformance with regulatory public dose limits has traditionally 
been demonstrated through modeling calculations and subsequent 
personal, environmental or emissions monitoring. Compliance with a 
risk-based standard would be accomplished in a similar manner and the 
limits would be expressed as the maximum risk that could be allowed to 
the receptor from radiation exposures at any given facility under 
regulatory control.
2. What concepts are important to understanding this issue?
    The primary concern from radiation exposure at the levels relevant 
for non-emergency situations is the increased risk of cancer. Two forms 
of radiation exposure, internal and external exposure, can occur 
depending upon the location of the source relative to the receptor. 
Internal exposures occur when a person inhales or ingests contaminated 
air, food, water or soil. External exposures occur because a person is 
near sources of radioactivity which are emitting penetrating radiation, 
such as x-rays, gamma rays, beta particles or neutrons. It should be 
noted that since the rule limits itself to the uranium fuel cycle, 
sources of radiation from machines, such as x-ray units and particle 
accelerators, are not covered by EPA standards. The term ``radiation 
dose,'' as used in dose standards, is a risk-weighted measure derived 
from the physical quantity of absorbed dose to an organ or tissue. As 
defined in this ANPR, ``radiation risk'' is the probability of an 
individual incurring a particular health effect per dose of radiation. 
Both dose and risk are commonly expressed over a lifetime or annualized 
depending on regulatory implementation.
3. What does 40 CFR part 190 say and what is basis of the existing 
standards?
    The existing standards have two components limiting exposures to 
the public. The first is a dose limit to members of the public, while 
the second is a limit on the quantity released of certain radionuclides 
or forms of radioactivity into the environment. The provision specified 
in 40 CFR 190.10(a) limits the annual dose to any member of the public 
from exposures to planned releases from uranium fuel cycle facilities 
to 25 mrem to the whole body, 75 mrem to the thyroid and 25 mrem to any 
other organ. The provision specified in 40 CFR 190.10(b) limits the 
total quantity of radioactive material releases for the entire uranium 
fuel cycle, per gigawatt-year of electrical energy produced, to less 
than 50,000 curies of krypton-85, 5 millicuries of iodine-129 and 0.5 
millicuries combined of plutonium-239 and other alpha-emitting 
transuranic radionuclides with half-lives greater than one year. Though 
views of risks have changed since 1977, the limits in 40 CFR 190.10(a) 
and (b) have as a basis a consideration of acceptable risk which served 
as a guide in developing the limits.
4. What Agency and national policies and approaches could be relevant?
    EPA considers risk in establishing standards and requirements 
across programs and environmental media. Consistent with this practice, 
the Agency has stated radiation-specific standards for protection of 
individuals in terms of dose, based on the underlying risk level.
    If the Agency should decide to retain a dose standard in 40 CFR 
part 190, that standard would be related to a level of health risk. In 
some cases, standards are expressed in terms of environmental flux 
(release rate) or concentration of radionuclides in the environment, 
but are also related to health impacts.
    EPA has heard from some stakeholders that a standard expressed as a 
level of risk could be more understandable for those less familiar with 
radiation science, as it would more clearly state the health outcome 
that the Agency views as acceptable. EPA believes it would also assist 
commenters in evaluating the merits of a risk standard if the Agency 
referred to the reasoning employed by the National Research Council/
National Academy of Sciences (the NAS committee) in its 1995 report, 
Technical Bases for Yucca Mountain Standards. The NAS committee 
recommended that EPA adopt a standard expressed as risk for two 
reasons. First, a risk standard is advantageous relative to a dose-
based standard because it represents a societal judgment regarding 
health impacts and therefore ``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.'' 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 (Technical Bases for Yucca Mountain Standards, 
1995, 64-65).\2\
---------------------------------------------------------------------------

    \2\ A different NAS committee expressed similar views in a 2002 
report, The Disposition Dilemma, pp. 33-34.
---------------------------------------------------------------------------

5. How would a risk standard compare to a dose standard?
    Planned or routine releases of radionuclides from nuclear fuel 
cycle facilities represent low-level ionizing radiation exposures to 
the public. As such, these non-emergency releases represent a potential 
increased risk of cancer to the public. Once an acceptable level of 
protection is identified, it may be translated to a release rate, as 
radionuclide concentrations in specific media, or another measurable 
unit, which can then serve as a regulatory limit expressed over time. 
Alternatively, site-specific modeling may be employed, based on 
measured releases, to calculate a dose or risk for comparison to the 
regulatory standard. This general approach to implementation would be 
used whether the standard is expressed in terms of risk or dose. As 
noted earlier, the compliance metric for radiation standards has more 
traditionally been either radiation dose or some measurable 
concentration or activity level.
    Both calculated doses and risks from radiation exposure differ 
depending on the specific radionuclides involved, as well as the 
pathways of exposure. The same activity level received by an exposed 
individual from different radionuclides or through different pathways 
leads to a different dose and carries different risks. If someone is 
exposed to multiple radionuclides, the risk of adverse health effects 
is determined by summing the risks from each radionuclide involved in 
the exposure. The primary technical difference between a risk standard 
and a dose standard is that the relationship between risk and dose has 
varied over time.\3\ Should this trend continue, there is the potential 
for a dose standard to diverge over time from its original underlying 
risk level. In contrast, a risk standard represents a constant level of 
risk, regardless of the type of facility, mix of radionuclides or 
changes in the underlying science involved in estimating the risk. 
Because it directly states the expectation for health outcome rather 
than relying on an overall correlation, it would typically not require 
an update, unless there are changes in what society deems an acceptable 
risk. If the standard were implemented by rule using measurable 
quantities such as effluent limits, however, these criteria would need 
to be updated, as they would be if a dose

[[Page 6515]]

standard changes. We are interested in stakeholder views on how this 
updating process might differ for a risk or dose standard.
---------------------------------------------------------------------------

    \3\ For example, the estimated risk of fatal cancer per rem of 
exposure increased in each of our three rulemakings for high-level 
radioactive waste (1985, 1993, 2001).
---------------------------------------------------------------------------

    Although our experience is that the risk per unit dose has 
generally increased over the years, the possibility also exists that 
further research may show that cancer risks are overestimated for a 
given dose or for certain radionuclides or exposure pathways. Another 
aspect to consider when assessing whether a risk standard would be 
appropriate is whether cancer morbidity (incidence) or cancer mortality 
(fatality) should be used as the basis for establishing any risk 
standard. While EPA often relies upon morbidity information for 
chemical carcinogens, the Agency has used mortality data as the basis 
of both its standards for disposal of transuranic and high-level 
radioactive wastes (40 CFR part 191) and the Yucca Mountain standards 
(40 CFR part 197). One factor to consider is that there appears to be 
increasing divergence between morbidity and mortality; in other words, 
estimates of cancer incidence from exposure to radiation continue to 
increase, but cancer fatality has grown at a slower rate or been 
reduced (EPA Radiogenic Cancer Risk Models and Projections for the U.S. 
Population, 2011). As a result, the Agency will take comment on whether 
morbidity data or mortality data, or a combination, would be more 
appropriate for the establishment of a potential risk standard.
    Although a risk standard, like a dose standard, would generally be 
implemented through modeling and the derivation of measurable 
quantities, the Agency is also aware that there may be some challenges 
specific to a risk standard, especially given that the regulatory 
system is based on dose, which is far more familiar to the radiation 
protection community and industry practice. If a standard were 
developed in the form of a risk level that was not to be exceeded, then 
any meaningful discussion on implementation would need to address how 
the risk would be translated into measurable quantities such as an 
effluent release rate into the environment, a concentration in 
environmental media, an intake by an individual or external radiation 
exposure at specific locations or to specific persons. As is the case 
with the current dose standard, proof of compliance would most likely 
rely heavily on the use of modeling results coupled with effluent data. 
Any accepted modeling use would need to be either detailed within the 
standard, or detailed by the implementing federal agency, possibly 
through development of subsequent regulations.
    As discussed earlier, the Agency recognizes that different 
radionuclides contribute to potential exposures. EPA further recognizes 
that different radionuclides are predominant at the different types of 
facilities within the nuclear fuel cycle. If the Agency were to move 
toward a risk standard, the Agency would conduct an analysis of the 
dose-risk relationship at the different types of facilities. What 
issues would the Agency need to consider with the implementation of a 
risk standard at the different facilities? For example, would the 
radionuclides of most concern for a given fuel cycle facility have 
different risk implications for different fuel cycle facilities? Could 
NRC implement a risk standard by establishing a corresponding dose 
limit that it determines would keep risks under the risk standard?
    While the Agency has not determined whether the technical merits or 
costs associated with developing a risk standard warrant a change from 
the traditional dose limits, the Agency believes it is reasonable to 
take comment at this time on how a potential risk limit may be 
implemented. Such a discussion could also inform the consideration of 
costs of implementing a risk standard.
    EPA also notes that both national and international radiation 
protection guidelines developed by bodies of non-governmental radiation 
experts, such as the ICRP and the National Council on Radiation 
Protection and Measurements (NCRP), generally recommend that radiation 
standards be established in terms of dose. National and international 
radiation standards, including the individual protection requirements 
in 40 CFR part 191, ``Environmental Radiation Protection Standards for 
Management and Disposal of Spent Nuclear Fuel, High-Level and 
Transuranic Radioactive Waste'', are established almost solely in terms 
of dose or concentration, not risk. Therefore, a risk standard would 
not allow a convenient comparison with the numerous existing dose 
guidelines and standards, nor with other sources of radiation exposure, 
but it would more readily allow comparisons to other EPA risk 
management decisions for chemicals.
    Lastly, it is important to note the potential costs that could be 
associated with moving from a dose standard to a risk standard. At the 
time of publication of this ANPR, the Agency has no information 
regarding potential costs to the regulated community. The Agency is 
seeking any data that are available on these potential costs.
6. Questions for Public Comment
    As the Agency considers the issue of establishing a standard 
expressed in terms of risk, we believe it to be appropriate to better 
understand the merits of this approach. The industry currently uses a 
dose limit, and the Agency is seeking information on how the industry 
would be affected by this change.
    Consequently, the Agency is seeking input on the following 
questions:
    a. Should the Agency express its limit for the purpose of this 
regulation in terms of radiation risk or radiation dose?
    b. Should the Agency base any risk standard on cancer morbidity or 
cancer mortality? What would be the advantages or disadvantages of 
each?
    c. How might implementation of a risk limit be carried out? How 
might a risk standard affect other federal regulations and guidance?

B. Issue 2--Updated Dose Methodology (Dosimetry). How should the Agency 
update the radiation dosimetry methodology incorporated in the 
standard?

1. Why is this issue important?
    The dosimetry used for the existing standards is outdated. Since 
the development of the existing dose standard, the methodology to 
calculate radiation exposure has changed with scientific progress. The 
existing standard has separate limits for exposure of the whole body 
and exposure of specific organs. More recent dosimetry accounts for 
both types of exposures in a single numerical value that provides more 
consistency and allows easier comparison of radiation exposures, 
regardless of whether they are internal or external, or whether they 
are likely to affect single or multiple organs. Newer dosimetry 
approaches also reflect a better understanding of the different 
sensitivity of various organs and allow more sophisticated calculations 
of the impacts to individuals and even to specialized groups (i.e., 
children, sensitive subpopulations).
2. What does the existing standard say? What is the technical basis?
    The standard in 40 CFR 190.10(a) states: ``The annual dose 
equivalent [must] not exceed 25 millirems to the whole body, 75 
millirems to the thyroid, and 25 millirems to any other organ of any 
member of the public as the result of exposures to planned discharges 
of

[[Page 6516]]

radioactive materials, radon and its daughters excepted, to the general 
environment from uranium fuel cycle operations and to radiation from 
these operations.'' These limits were based on the Federal Radiation 
Protection Guidance in existence at that time (26 FR 4402, May 18, 1960 
and 26 FR 9057, September 26, 1961).
    The federal guidance documents, in turn, were based on 
recommendations of the ICRP, which provides expert guidance on dose 
limits in view of the current understanding of dose-response 
relationships for exposure to ionizing radiation. Many international 
standards and national regulations addressing radiological protection 
are based on or take into account the ICRP's recommendations. The 
guidance in effect during the development of the proposed \4\ 
standards--ICRP Publication 2 (1959)--recommended dose limits aimed at 
avoiding deterministic effects and limiting stochastic effects, 
including leukemia and other cancers, as well as genetic effects. The 
dose limitation system at that time was based on the concept of the 
critical organ, defined as the organ or tissue most susceptible to 
damage from radiation. Separate dose limits were set for different 
groups of tissues, taking into account the potential for different 
types of radiation to cause greater damage depending on the mode of 
exposure. For example, alpha radiation poses less risk for external--or 
whole body--exposure because it is easily shielded even by the skin, 
but can cause greater damage to critical organs than other types of 
radiation when inhaled or ingested. These concepts, underlying the ICRP 
recommendations at the time, served as the basis of the existing dose 
limits to members of the public in 40 CFR part 190.
---------------------------------------------------------------------------

    \4\ In the interim between publication of the proposed rule and 
publication of the final 40 CFR part 190 standards, ICRP 26 was 
finalized (adopted Jan 17, 1977). However sufficient time was not 
available to incorporate the ICRP 26 findings, and the Agency went 
forth with finalization of the proposed rule which was based on ICRP 
2.
---------------------------------------------------------------------------

3. What has changed and how are those changes important?
    Since the publication of the existing regulation, advancements have 
been made in understanding radiation dosimetry. The ICRP updated its 
recommendations to reflect a better understanding of the different 
sensitivity of various organs and of the risks from different types of 
radiation. Of primary importance is that the critical organ concept was 
abandoned in favor of a new concept referred to as the effective dose 
equivalent (ICRP Publication 26, 1977). This new concept, later renamed 
effective dose (ICRP Publication 60, 1991), provides a single dose 
indicator that accommodates different types of radiation as well as 
different modes of exposure. The use of a unified dose facilitates 
understanding and comparison of the radiation exposures, regardless of 
whether they are internal or external, or whether they are likely to 
affect single or multiple organs. Further studies since the 1977 rule 
have also reinforced that some populations, such as pregnant women and 
children, are more sensitive to radiation and have allowed more 
specific calculations of risks to such groups. Such information is not 
reflected in the dose limits--or their form--in the existing uranium 
fuel cycle standards, which are based on the older ``critical organ'' 
system. Beyond the fact that the existing standards do not reflect the 
most recent scientific understanding, the use of an outmoded system 
also poses some compliance challenges. The models and methods to 
predict the dispersion of radionuclides, the modes of exposure, and the 
movement of radionuclides through the body (biokinetics) are more 
advanced today than in the past. However, the most sophisticated models 
are tailored to work with the more recent dosimetry systems and are not 
always compatible to assess compliance with limits expressed in the 
older systems. At the same time, the older models are less and less 
supported. This means that compliance assessments for the existing dose 
limit cannot take advantage of the best implementation tools. Thus, for 
reasons both scientific and practical, we believe it is worthwhile to 
consider how to update the dose methodology if the rule is revised.
4. What policies and approaches are relevant?
    As noted above, EPA's dose limits take into account recommendations 
of the ICRP, which has updated its guidance documents several times 
since 40 CFR part 190 was issued. ICRP Publication 26 (1977) abandoned 
the critical organ concept of ICRP Publication 2 in favor of a new 
concept referred to as the effective dose equivalent (now called 
effective dose). The effective dose is a weighted sum of tissue doses 
intended to represent the same cancer risk from a non-uniform 
irradiation of the body as that from uniform whole body irradiation.\5\ 
The effective dose concept has been used in all subsequent ICRP 
publications to date.
---------------------------------------------------------------------------

    \5\ In actuality, the weighting factors used to calculate 
effective dose equivalent are not sufficiently precise to equate 
risks for a given dose. The ``true'' risk is best calculated using 
radionuclide-specific, pathway-specific analyses and absorbed dose 
to an organ or whole body.
---------------------------------------------------------------------------

    The ICRP guidance was updated beyond ICRP 26 and expanded with ICRP 
Publication 60 (1991), based on additional information on the 
sensitivity of different tissues and organs in the body. ICRP 60 also 
made it possible to develop age- and gender-specific dose estimates. 
ICRP 60 has been widely implemented worldwide and serves as the basis 
for EPA radiation dose standards, notably the amended Yucca Mountain 
standards issued in 2008.
    The Agency has explained its adoption of the effective dose concept 
in previous rulemakings. In the Agency's 1989 Clean Air Act (CAA) 
rulemaking establishing National Emissions Standards for Hazardous Air 
Pollutants (NESHAPs) in 40 CFR part 61, Subpart I,\6\ EPA said the 
following about effective dose equivalent (54 FR 51662, December 15, 
1989):
---------------------------------------------------------------------------

    \6\ Subpart I established standards for air emissions from NRC 
licensees, including uranium fuel cycle facilities, and non-DOE 
federal facilities not licensed by NRC. Subpart I was later 
rescinded based on the Administrator's conclusion that NRC's 
regulatory implementation protected public health with ``an ample 
margin of safety'' (60 FR 46206, September 5, 1995, and 61 FR 68972, 
December 30, 1996). Subpart I established standards for the air 
pathway of 10 mrem/year EDE, with no more than 3 mrem/year EDE from 
radioiodine.

    Since 1985, when EPA proposed dose standards regulating NRC 
licensees and DOE facilities, a different methodology for 
calculating dose has come into widespread use, the effective dose 
equivalent (EDE). In 1987, EPA, in recommending to the President new 
guidance for workers occupationally exposed to radiation, accepted 
this methodology for the regulation of risks from radiation. This 
method, which was originally developed by the International 
Commission on Radiological Protection, will be used by EPA in all 
the dose standards promulgated in this ANPR. In the past, EPA dose 
standards were specified in terms of limits for specific organ doses 
and the `whole body dose', a methodology which is no longer 
consistent with current practices of radiation protection.
    The EDE is simple, is more closely related to risk, and is 
recommended by the leading national and international advisory 
bodies. By changing to this new methodology, EPA will be converting 
to the commonly accepted international method for calculating dose. 
This will make it easier for the regulated community to understand 
and comply with our standards.
    The EDE is the weighted sum of the doses to individual organs of 
the body. The dose to each organ is weighted according to the risk 
that dose represents. These organ doses are then added together, and 
that total is the effective dose equivalent. In this manner, the 
risk from different sources of radiation can be controlled by a 
single standard.


[[Page 6517]]


    This rulemaking (54 FR 51662) also noted that the EPA Science 
Advisory Board (SAB) commented that ``EPA should use the effective dose 
equivalent concept for regulations protecting people from exposure to 
radiation.''
    The latest update, in ICRP Publication 103 (2007), provided updated 
radiation protection guidance, including new tissue weighting (i.e., 
sensitivity) factors, but left the primary radiation protection 
guidance from 1991 virtually unchanged. ICRP 103 is the most recent 
guidance but, as discussed in more detail below, has not been applied 
in EPA regulations to date.
    Other EPA policies are also relevant because, while the Agency 
takes into account ICRP guidance, regulatory limits must reflect 
additional factors. The ICRP recommended--in both Publication 60 and 
Publication 103--that public exposures be limited to 100 mrem (0.001 
Sv) per year. However, this applies in principle to all man-made 
sources of radiation. In setting regulatory limits, we allow only a 
fraction of 100 mrem from a single source, such as a uranium fuel cycle 
facility. As discussed further in section II.A of this ANPR 
(``Consideration of a Risk Limit to Protect Individuals''), the dose 
limits used in our radiation regulations are based on an assessment of 
the associated risks. In the past, based on ICRP 26, EPA radiation 
policies and regulations have used 15 mrem/year as a dose limit that 
aligns with the Agency's goals and corresponds to a limit of 25 mrem to 
the whole body and 75 mrem to any organ under the obsolete dose 
methodology for certain regulatory applications.\7\ The corresponding 
dose under ICRP 103 has not been established. EPA is reviewing the 
implications of ICRP 103 for our revised dose and risk estimates. EPA 
will address the issue in a rulemaking if one is pursued.
---------------------------------------------------------------------------

    \7\ See OSWER Directive 9200.4-18, EPA's Yucca Mountain 
standards at 40 CFR part 197, and the preamble to the 1993 revision 
of the 40 CFR part 191 standards [58 FR 66411, December 20, 1993].
---------------------------------------------------------------------------

    It should be noted that the Agency does not have established 
policies or guidance on the application of age- and gender-specific 
dose calculations to determine compliance with a dose standard.\8\ 
However, we are considering the application of age- and gender-specific 
dose calculations to determine compliance with the dose standard. 
Whether expressed in terms of risk or dose, the standard must identify 
the person(s) against whom compliance will be assessed. The standards 
at 40 CFR part 190 currently specify that the dose standard applies to 
``any member of the public.'' We have several other ``any member of the 
public'' standards that specify the use of ICRP 26 dosimetry and an 
associated concept, the ``reference man.'' Concerns have been raised 
that the ``reference man'' concept, combined with the fact that neither 
the ICRP 26 dosimetry nor the ICRP 2 methodology can provide age- and 
gender-specific calculations, does not assure that children or other 
vulnerable population segments are protected or adequately considered. 
The models beginning with ICRP 60 are able to address different age and 
gender cohorts, which allows the differing impact of radiation 
exposures to be evaluated. More specifically, ICRP Publication 89 
(2002) provides anatomical and physiological data for males and females 
at ages newborn, 1 year, 5 years, 10 years, 15 years and adult that 
allow for age- and gender-specific estimates of dose to be calculated 
for these reference individuals. We note that, while the current 
standard is presented as an annual dose, it is established at a level 
that provides protection for an individual over a lifetime (i.e., at 
all ages). Nevertheless, we are examining the issue to confirm the 
protectiveness of our standards as written for all segments of the 
population. Specifically, we are modifying the computer model CAP-88 
PC, which is used to determine compliance with Clean Air Act 
radionuclide emission standards, to evaluate the relationship between 
radionuclide intake and dose for different age groups. This technical 
study will inform our review of our radiation protection policies, and 
we will make our findings available to the public. We anticipate that 
this question will be addressed broadly within the Agency to identify 
the most appropriate approach to resolving the issue as a whole, rather 
than for each individual rule. However, comments on the use of 
reference man or the appropriateness of specifying age- and gender-
specific dose calculations are welcome. Such comments will be 
considered both in the context of this rule and as part of the overall 
Agency discussion on the topic.
---------------------------------------------------------------------------

    \8\ The Agency's ``Guidelines for Carcinogen Risk Assessment'' 
(2005) provide age-specific adjustments for carcinogens with a 
mutagenic mode of action for chemical carcinogens. Regulatory 
applications for radioactive compounds have not been determined.
---------------------------------------------------------------------------

5. What aspects of this issue are most important and what options might 
be considered to address this issue in any revised standards?
    The Agency intends to review this portion of the regulation to 
ensure its continued protectiveness in light of these technological 
advances. We acknowledge that the dose methodology on which the 
existing standard is based is now outmoded, and compliance with the 
existing standard poses some implementation challenges. These 
challenges are proving compliance with an organ-specific dose limit and 
with the current suite of compliance models using an effective dose 
methodology. As an example, most health physicists conducting 
compliance at nuclear power plant facilities are trained in the 
calculation and use of effective dose. Requiring compliance with an 
organ-specific dose necessitates the use of a different calculating 
technique, and potentially requires additional training. If the rule is 
revised, there would be little justification for retaining outdated 
science as the basis for dose limits. Therefore, the primary question 
is how the Agency would reflect more recent dose methodology. There are 
arguments to be made for using either ICRP 60 or ICRP 103, or for 
providing flexibility without specifying the ICRP basis.
    As noted earlier, there is considerable experience worldwide in 
implementing the recommendations of ICRP 60. The EPA has issued 
guidance documents to allow detailed dose calculations for specific 
exposure situations, such as would be needed to determine compliance at 
a nuclear fuel cycle facility. A basis for calculating risks to more 
sensitive populations has also been developed, though (as noted 
earlier) there is not clear guidance on how, if at all, such 
information should be used in regulations.
    The nuclear industry is familiar with the guidance and has 
experience in using compliance and assessment tools that are compatible 
with the ICRP 60 risk basis. Relying on ICRP 60 as the basis for a 
revised rule would eliminate any reference to an outdated individual 
organ calculation. The methodology is biologically and physically 
robust in its approach and has been properly peer-reviewed, implemented 
and supported by the publication of important federal guidance. This 
approach would provide a well-established methodology and compliance 
tools using science that is considerably more advanced than that used 
currently in 40 CFR part 190--but not the absolute most recent science.
    Using the most recent science--which, in principle, is the 
preferred approach--would imply that ICRP 103 should be adopted as the 
basis for any revised rule. Unfortunately, ICRP 103 has not been widely 
utilized because the ICRP has yet to provide the detailed information 
needed for full implementation of the most recent dose coefficients for 
specific radionuclides

[[Page 6518]]

and organs. Factors and biokinetic models to support such calculations 
are anticipated in future ICRP publications but have not yet been 
released, so there is a lack of appropriate modeling and compliance 
tools now available. Furthermore, in order to provide the complete set 
of tools for calculating dose to different population age groups under 
ICRP 103, the Agency would need to update Federal Guidance Report No. 
13, Cancer Risk Coefficients for Environmental Exposure to 
Radionuclides. However, the Federal Guidance Technical Report Working 
Group under the Interagency Steering Committee on Radiation Standards 
has convened to update these reports and the first draft could be 
available by the end of 2014. As such, these data could be available 
prior to any proposal of a revised standard. Thus, the analysis that 
relies on the most recent science (ICRP 103) could be conducted in a 
timely manner consistent with the time necessary for a rulemaking.
    A third option would be to establish a dose limit but not to 
specify the ICRP basis for implementation. Under this approach, the 
details of implementation would be left to the NRC. NRC is beginning a 
comprehensive review of its regulations with the long-term view of 
adopting ICRP 103, which is likely to take a number of years. During 
this transition period, it may be appropriate to allow NRC to determine 
which method of calculation should be used, taking into account the 
views of the public. This could also anticipate the use of future ICRP 
recommendations beyond ICRP 103. An example of this approach is EPA's 
standards for the proposed Yucca Mountain disposal facility.\9\ The 
advantage of this approach is that it allows the flexibility to use 
updated ICRP information as soon as (but not before) it can reasonably 
be implemented on a large-scale. A drawback of this approach is that it 
leaves some uncertainty as to what risk level is represented by the 
dose limit. That is, a dose of 15 mrem can represent a slightly 
different level of risk depending on the specific radionuclides, 
exposure situation and dose-risk factors. Therefore, a dose of 15 mrem 
could, in the future, represent a different level of risk than 
originally expected. The difference would likely be small unless there 
are major changes in our understanding of radiation risks. Recent 
scientific advances have primarily influenced the understanding of 
risks from specific radionuclides to specific organs and to sensitive 
subpopulations--but have reinforced the overall dose-risk factors that 
serve as the major basis for most of EPA's radiation regulations and 
policies.
---------------------------------------------------------------------------

    \9\ We provided similar discretion to NRC in our amendments to 
the Yucca Mountain standards. While we specified that the Department 
of Energy (DOE) must use ICRP 60 methodologies to project doses in 
its long-term performance assessment, we stated that NRC could 
permit the use of future dosimetric systems, as long as they were 
issued by consensus organizations, adopted by EPA into Federal 
Guidance, and consistent with the effective dose equivalent 
methodology first established in ICRP 26 and continued in ICRP 60. 
See 40 CFR part 197, Appendix A.
---------------------------------------------------------------------------

    Finally, it is important that the economic impacts of any change in 
the dose methodology be carefully considered and acknowledged. The NRC 
staff has considered cost-benefit considerations in providing its 
recommendation to the NRC Commissioners for Options to Revise Radiation 
Protection Regulations and Guidance with Respect to the 2007 
Recommendations of the ICRP (Dec 18, 2008). This paper identifies the 
inefficiencies with industry meeting the requirements using two 
different methods (40 CFR part 190 requirements are incorporated into 
10 CFR part 50 Appendix I design objectives). This being the case, any 
change from the ICRP 2 approach to more contemporary dosimetry 
methodologies could yield a cost savings for the industry. The Agency 
is interested in receiving any data that are available on these 
potential cost savings.
    In summary, the Agency is seeking input from the public on options 
that should be considered to update the radiation dosimetry for the 
standard. The range of options identified for consideration are: (1) 
Revise the dose limits to an ``effective dose'' standard using ICRP 60 
methodology; (2) Revise the dose limits to an ``effective dose'' 
standard using ICRP 103 methodology; and (3) Specify a dose limit and 
leave the decision regarding methodology to NRC. We welcome comments on 
these options, on additional options that we have not identified, and 
on factors that should be considered in selecting and implementing a 
dose methodology.
6. Questions for Public Comment
    With the aforementioned as background, the Agency is seeking input 
on the following questions:
    a. If a dose standard is desired, how should the Agency take 
account of updated scientific information and methods related to 
radiation dose--such as the concept of committed effective dose?
    b. In updating the dose standard, should the methodology in ICRP 60 
or ICRP 103 be adopted, or should implementation allow some 
flexibility? What are the relative advantages or disadvantages of not 
specifying which ICRP method be used for the dose assessment?

C. Issue 3--Radionuclide Release Limits. The Agency has established 
individual limits for release of specific radionuclides of concern. 
Based on a concept known as collective dose, these standards limit the 
total discharge of these radionuclides to the environment. The Agency 
is seeking input on: Should the Agency retain the radionuclide release 
limits in an updated rule and, if so, what should the Agency use as the 
basis for any release limits?

1. Why is this issue important?
    The radionuclide specific release standards established in 40 CFR 
190.10(b) set a limit on the total discharge of long-lived 
radionuclides released to the environment. These limits ensure that the 
environmental impacts of these radionuclides on the human population 
have a limited effect throughout the duration of their existence in the 
biosphere.
2. What do the existing standards say on this issue?
    The standards at 40 CFR 190.10(b) specify: ``The total quantity of 
radioactive materials entering the general environment from the entire 
uranium fuel cycle, per gigawatt-year of electrical energy produced by 
the fuel cycle, contains less than 50,000 curies of krypton-85, 5 
millicuries of iodine-129, and 0.5 millicuries combined of plutonium-
239 and other alpha-emitting transuranic radionuclides with half-lives 
greater than one year.''
    Excerpts from the 1976 FES (Final Environmental Statement, 1976, 
Vol. 1, p. 5), indicate the Agency's rationale and the regulatory 
facilities of concern in mandating this second set of environmental 
standards: ``Finally, although fuel reprocessing plants are few in 
number, they represent the largest single potential source of 
environmental contamination in the fuel cycle, since it is at this 
point that the fuel cladding is broken up and all remaining fission and 
activation products become available for potential release to the 
environment.'' Other parts of the nuclear fuel cycle emit much less of 
the radionuclides subject to 40 CFR 190.10(b) because the releases to 
the environment come after the fission process. Thus reprocessing 
facilities and, to a lesser extent, nuclear power plants are the focus 
of 40 CFR 190.10(b). The Agency developed this portion of the standard 
specifically to address the potential environmental burden associated 
with the resulting long-lived

[[Page 6519]]

radionuclides and to ensure that the risk associated with any long-term 
environmental burden is incurred only in return for a beneficial 
product: electrical power. Furthermore, the Agency stated that 
``attention to individual exposure alone can result in inadequate 
control of releases of long-lived radionuclides, which may give rise to 
substantial long-term impacts over the lifetime of the radionuclide.''
    The Agency based the limits for plutonium-239 and other alpha-
emitters on emissions levels that could be achieved with best available 
control technologies. The limits for krypton-85 and iodine-129 relied 
on control technologies demonstrated on a laboratory scale, but not yet 
in actual use by 1975. Other long-lived radionuclides considered for 
regulation under this portion of the standard (i.e., tritium and 
carbon-14) ultimately were not included because appropriate control 
technologies were either not feasible or unavailable.
3. What has changed and how are those changes relevant?
    The Agency developed the existing standard under the assumption 
that U.S. commercial reprocessing would be available. However, for 
policy and economic reasons, reprocessing never achieved the expected 
scale, and no commercial reprocessing plants are currently operating in 
the U.S. As of the drafting of this ANPR, however, there is renewed 
interest in Congress and the industry regarding the possibility of 
reprocessing as evidenced by testimony during hearings of the 
President's Blue Ribbon Commission on America's Nuclear Future. The 
broader nuclear industry is anticipating growth, with applications for 
new nuclear power plants submitted to the NRC and the start of 
construction at two power plant sites. Additionally, if the nation 
chooses to control carbon emissions from power generators, the number 
of nuclear power plants operating in the U.S. may increase further.
4. What policies and approaches are relevant?
    The release limits were defined to limit exposures to populations 
wider than those in the immediate vicinity of a facility. Over the 
intervening decades, protection standards for individuals have become 
preferred, with collective dose considered less useful for assessing 
the risks of a given activity. Particularly in cases where extremely 
small doses combine with extremely large populations, collective dose 
can give a misleading view of the overall impact of an activity (and 
impact on individuals), based on statistical estimates of the number of 
future health effects. Collective dose should thus be used with 
caution. For example, it can be used to provide meaningful comparisons 
of alternatives for a proposed action (e.g., in facility design).
    Since the development of the release limits was motivated largely 
by concerns about emissions from reprocessing facilities, prospects of 
spent nuclear fuel reprocessing conducted both nationally and 
internationally may have a bearing on reconsideration of this issue.
    There have been active reprocessing facilities in 15 countries, 
including the U.S., although some of these facilities were more 
research-oriented as opposed to commercial reprocessing facilities. Of 
the current operating facilities, the most widely known are the 
facilities at Sellafield (United Kingdom) and La Hague (France), which 
constitute the first and second leading producers globally for krypton-
85. Both facilities discharge krypton-85 directly to the environment. 
Efforts at these plants are made to control the releases of iodine-129, 
and tracking the levels of this radionuclide over the years has shown 
decreasing emissions relative to reprocessing production quantities.
    It is also useful to examine the experience of implementing the 
release limits in practice. While EPA sets the part 190 standards, the 
NRC has the responsibility to implement and enforce them for its 
licensees. Its requirements for licensees are found in 10 CFR part 20, 
``Standards for Protection Against Radiation,'' specifically: 10 CFR 
20.1301(e), which requires compliance with 40 CFR part 190, and 10 CFR 
20.2203(a)(4), which further requires reporting of radiation levels or 
releases in excess of the standards in 40 CFR part 190. However, 
neither provision describes how to demonstrate compliance with 40 CFR 
part 190, although NRC has issued guidance to licensees for light water 
reactors in Generic Letters (GL) 79-041, GL79-070 and NUREG-0543 (ADAMS 
Accession No. ML081360410).
    In anticipation that spent nuclear fuel reprocessing may again be 
pursued in the U.S., the NRC directed its former technical advisory 
committee, the Advisory Committee on Nuclear Waste and Materials 
(ACNW&M), to define the issues most important to the NRC concerning 
fuel reprocessing facilities. The ACNW&M published the results of their 
effort in NUREG-1909, ``Background, Status, and Issues Related to the 
Regulation of Advanced Spent Nuclear Fuel Recycle Facilities.'' The 
following excerpt from NUREG-1909 summarizes the ACNW&M's finding 
regarding 40 CFR part 190: ``Of particular relevance to fuel recycle is 
40 CFR 190.10(b) which limits the release of krypton-85 and iodine-129 
from normal operations of the uranium fuel cycle. Because fuel 
reprocessing is the only step of the nuclear fuel cycle that could 
release significant amounts of these radionuclides during normal 
operations, these limits are effectively release limits for the fuel 
reprocessing gaseous effluent.'' (NUREG-1909, p.134) Other issues 
identified by the ACNW were: (1) Meeting the standard with available 
technologies may not be feasible; (2) limits on releases of carbon-14 
and tritium may need to be considered; (3) the cost-benefit analysis 
for collective dose in 40 CFR 190.10(b) should be reconsidered; and (4) 
their belief that the existing regulation does not include fabrication 
of fuels enriched with plutonium or actinides other than uranium.
5. What compliance history exists for the current standards?
    The Agency has reviewed compliance issues for these standards and 
has found challenges with determining and enforcing compliance. Without 
the operation of a reprocessing plant(s), there is little likelihood of 
exceeding the existing standards for the fission products krypton-85 
and iodine-129. The basis for this statement is that both of these 
radionuclides are fission products (the result of the fission reaction 
occurring in the nuclear reactor) contained within the fuel rods at the 
nuclear power plants, and the fission products cannot escape unless the 
metal cladding around the fuel pellets ruptures during use or storage 
after removal from the reactor. During normal operations, the failure 
rate of cladding is insignificantly small. Uranium mining and milling, 
uranium conversion, uranium enrichment and fuel fabrication facilities 
do not generate these radionuclides since no fission reaction occurs 
during these processes.\10\ Thus, only nuclear power plants and 
potential reprocessing facilities need to be considered when 
determining compliance with krypton-85 and iodine-129 limits.
---------------------------------------------------------------------------

    \10\ Fuel fabrication facilities for mixed uranium-plutonium 
fuel (MOX fuel) could have some plutonium releases, but these would 
not be anticipated to approach the current limit.
---------------------------------------------------------------------------

    NRC implements 40 CFR 190.10(b) through its oversight and 
inspection authorities for its licensees found in both 10 CFR part 20 
and 10 CFR part 50. Specifically, 10 CFR part 20 includes the 
requirement that licensees comply

[[Page 6520]]

with 40 CFR part 190. Technical specifications for commercial nuclear 
power plants are found in Appendix I of 10 CFR part 50, ``Domestic 
Licensing of Production and Utilization Facilities.'' These 
specifications provide annual dose objectives for nuclear power plants 
that are considered ``As Low As [is] Reasonably Achievable'' (ALARA). 
The ALARA objectives are 3 mrem/year for liquid effluents and 5 mrem/
year for gaseous effluents. The NRC has stated that, ``. . . it was 
feasible for a licensee to inherently show compliance of 40 CFR part 
190 limits by meeting the dose objectives in 10 CFR part 50 Appendix 
I.'' \11\ The NRC staff has reviewed a sampling of effluent reports 
from 1981 to 2005, to assess the levels of krypton-85, iodine-129 and 
plutonium-239 and other transuranic alpha emitters released from 
operating nuclear power plants. Their findings were that these levels, 
on an annual unit of gigawatt-year of electrical energy produced, were 
significantly less than the limits in 40 CFR part 190. The standards 
apply to the industry's release of certain radionuclides proportional 
to the amount of electricity generated. Thus compliance relies on 
annual nationwide emissions for all applicable uranium fuel cycle 
facilities. If there were a case (such as multiple reprocessing plants) 
where the implementing agency considered that overall emissions were 
exceeding the standard, then the regulator may find it necessary to 
apportion or divide the standard to make it applicable to individual 
facilities. Further guidance may be necessary in order to detail a 
method for apportioning this standard. This uncertainty, and the 
difficulty in making and enforcing regulatory decisions about which 
facilities must undergo upgrades to meet the standards, makes 
implementing the standards extremely difficult at best if the situation 
arises where the entire uranium fuel cycle emissions are approaching 
the regulatory limit. EPA's goal in any revision of the standards is to 
ensure adequate public health protections, while providing appropriate 
flexibility to implementing agencies.
---------------------------------------------------------------------------

    \11\ NRC Letter from Margie Kotzalas, MOX Branch Chief to Ron 
Fowler; Subj: Response to Concerns Regarding Ensuring Compliance 
with 40 CFR part 190. Sept. 24, 2008.
---------------------------------------------------------------------------

6. What aspects of the issue are most important and what options are 
available to address this issue in revised standards?
    The Agency determined in the development of 40 CFR part 190 that 
these standards would be important in reducing the environmental dose 
commitments for persistent radiological contaminants, and still 
considers this a desirable goal. The radionuclides specified in these 
standards were identified as those that could potentially disperse and 
deliver doses to widespread populations as they migrate through the 
biosphere. However, the current form of the standards appears to be 
impractical to implement. Furthermore, few consider collective dose 
appropriate for risk calculations or for use as a regulatory basis 
because ``the summation of trivial average risks over very large 
populations or time periods . . . [produces] a distorted image of risk, 
completely out of perspective with risks accepted every day.'' (NCRP, 
1995) In more recent radiation regulations, we have relied instead on 
individual dose limits to limit exposures to the public, combined with 
effluent or concentration limits to protect specific environmental 
resources (e.g., 40 CFR part 197).
    There are several options under consideration for this portion of 
the regulation:
    (a) Eliminate this portion of the regulation and rely on other 
limits to provide protection of public health and the environment.
    (b) Use the concept from the existing standards of limiting the 
environmental burden of long-lived radionuclides in the biosphere as a 
guide, and calculate equivalent standards that could apply outside 
individual facilities (e.g., reprocessing plants).
    (c) Use risk or dose to a designated receptor to develop 
radionuclide specific standards that would apply outside a given 
individual facility.
    (d) Any additional options considered technically sound and 
developed by other stakeholders.
7. Questions for Public Comment
    a. Should the Agency retain the concept of radionuclide-specific 
release limits to prevent the environmental build-up of long-lived 
radionuclides? What should be the basis of these limits?
    b. Is it justifiable to apply limits on an industry-wide basis and, 
if so, can this be reasonably implemented? Would facility limits be 
more practicable?
    c. If release limits are used, are the radionuclides for which 
limits have been established in the existing standard still appropriate 
and, if not, which ones should be added or subtracted?

D. Issue 4--Water Resource Protection. How should a revised rule 
protect water resources?

1. Why is this issue important?
    Ground water and surface water are valuable resources necessary to 
maintain human life and healthy ecosystems now and in the future. 
Uranium fuel cycle facilities have the potential to release radioactive 
materials and contaminants that can get into surface water or ground 
water. EPA believes it better to take measures that prevent water 
contamination than to subsequently have to clean up the contamination.
2. What does 40 CFR part 190 say? What is the technical basis?
    The existing standard for nuclear power operations does not include 
a separate provision for protection of water resources at or 
geographically near these facilities. The FES (Final Environmental 
Statement, 1976, Vol. 1, p. 66) cites the rationale for not including 
water-specific standards: ``. . . liquid pathway releases from these 
facilities result in much smaller potential doses than do noble gas 
releases [air releases]. Detailed studies of several specific 
facilities have revealed no actual dose to any individual from this 
pathway as great as 1 mrem per year.'' Thus, the Agency determined at 
that time that ground water contamination at these facilities was not 
likely to be a pervasive problem.
3. What has changed and how are those changes important?
    Ground water contamination has occurred at a number of nuclear 
power plants \12\ and other uranium fuel cycle 
facilities.13 14. The primary radionuclide responsible for 
ground water contamination at power plants is tritium, for which the 
Agency has established a Maximum Contaminant Level (MCL) of 20,000 
picocuries/liter (pCi/L) for drinking water. Tritium is a radioactive 
isotope of hydrogen that can replace one of the stable hydrogen atoms 
in the water molecule, thus

[[Page 6521]]

producing tritiated water. In the environment, tritiated water behaves 
very similarly to ordinary water. Tritium levels as high as 3.2 million 
pCi/L have been reported to the NRC in the ground water at some nuclear 
power plants. These elevated levels of tritium in ground water at these 
plants have prompted the NRC to create two specialized task forces to 
examine the issue. The task forces did not identify any instances where 
the public's health was impacted but did nevertheless recommend 
modifications to a number of regulatory documents.
---------------------------------------------------------------------------

    \12\ U.S. Nuclear Regulatory Commission (NRC). Leaks and Spills 
of Tritium at U.S. Commercial Nuclear Power Plants, Revision 6 
(Washington, DC: 2010).
    \13\ U.S. General Accounting Office (GAO). Nuclear Waste 
Cleanup, DOE's Paducah Plan Faces Uncertainties and Excludes Costly 
Cleanup Activities. GAO/RCED-00-96. (Washington, DC: 2010).
    \14\ U.S. Nuclear Regulatory Commission (NRC). Environmental 
Assessment for the Renewal of U.S. Nuclear Regulatory Commission 
License No. SNM-1227 for AREVA NP, Inc. Richland Fuel Fabrication 
Facility. (Washington, DC: 2009).
---------------------------------------------------------------------------

    Because of these releases to ground water at these sites, and 
related investigations, the Agency considers it prudent to re-examine 
its initial assumption in 1977 that the water pathway is not a pathway 
of concern. At this time the Agency has not developed formal options 
for this issue. Ground water monitoring is currently conducted at all 
facilities subject to NRC requirements established in 10 CFR parts 20 
and 50, so the economic impact of potential provisions for ground water 
protection is largely undefined at this time, and the Agency is 
interested in estimates of potential costs. If the Agency proceeds with 
proposing options for either surface or ground water protection, then 
it would conduct a cost-benefit analysis for this issue.
4. What policies and approaches are relevant?
    When considering water resources, the Agency must determine whether 
there is a need to protect the resource and what protection is 
appropriate. The Agency has numerous authorities to protect ground 
water and surface water from contamination, and an examination of the 
applicability of these authorities is appropriate.
    Ground water. In the years after 1977 when 40 CFR part 190 was 
issued, EPA increased its efforts to address ground water contamination 
including implementing new statutory authorities such as Superfund, 
hazardous waste programs, protection of underground storage tanks and 
protection of sources of drinking water. In recognition of the growing 
importance of ground water and increasing threats of contamination, EPA 
first outlined a comprehensive approach to ground water protection in 
its 1984 Ground Water Protection Strategy. EPA, with review by many 
federal agencies through the Administration's review procedures, 
replaced that strategy in July 1991, with another one titled Protecting 
the Nation's Ground Water: EPA's Strategy for the 1990s--The Final 
Report of the EPA Ground-Water Task Force. That strategy is still in 
effect.
    Consistent with part D of the July 1991 strategy, EPA implements a 
policy that ``the Agency will use maximum concentration limits (MCLs) 
under the Safe Drinking Water Act \15\ as ``reference points'' for 
water resource protection efforts when the ground water in question is 
a potential source of drinking water. Water quality standards, under 
the Clean Water Act, will be used as reference points when ground water 
is hydrologically connected to surface water ecological systems. Where 
MCLs are not available, EPA Health Advisory numbers or other approved 
health-based levels are recommended as points of reference. If such 
numbers are not available, reference points may be derived from the 
health-effects literature where appropriate. The strategy also notes 
that ``[r]eaching the MCL or other appropriate reference point would be 
considered a failure of pollution prevention.''
---------------------------------------------------------------------------

    \15\ The EPA national primary drinking water standards under the 
Safe Drinking Water Act (SDWA) set limits on radionuclide 
concentrations--Maximum Contaminant Levels (MCLs)--in community 
drinking water systems (40 CFR 141.66). These SDWA regulations do 
not apply directly to ground water not used as drinking waters. MCLs 
generally only apply to finished drinking water after treatment.
---------------------------------------------------------------------------

    Site clean-up and other remedial actions generally use the MCLs as 
a cleanup goal and also take other factors into account. In some cases, 
EPA institutes the level of protection by directly incorporating the 
numerical limits from the Safe Drinking Water Act (SDWA) MCLs into 
other regulations. The 1991 strategy states relative to cleanup that 
``[r]emediation will generally attempt to achieve a total lifetime 
cancer risk level in the range of 10-4 to 10-6 
and exposures to non-carcinogens below appropriate reference doses.''
    EPA considered the issue of ground water standards for 
radionuclides most recently in the development of ``Environmental 
Protection Standards for Yucca Mountain'' (66 FR 32074, June 13, 2001). 
In this regulation the Agency states that ``Ground water is one of our 
nation's most precious resources because of its many potential uses . . 
. When that water is radioactively contaminated, each of those uses 
completes a radiation exposure pathway for people. Ground water 
contamination is also of concern to us because of potential adverse 
impacts upon ecosystems, particularly sensitive or endangered 
ecosystems. For these reasons, we believe it is a resource that needs 
protection.'' (66 FR 32106) In this regulation, consistent with the 
Agency's Ground Water Protection Strategy, EPA adopted levels 
consistent with the drinking water MCLs as a basis for protecting the 
ground water resource. It may be noted that the ground water protection 
standards were applied prospectively at Yucca Mountain, in the sense 
that potential contamination of ground water in the accessible 
environment would not be expected for many hundreds to thousands of 
years. As such, the radionuclides of most concern for geologic disposal 
would not necessarily be the same as for operating fuel cycle 
facilities.
    EPA has the authority under the Atomic Energy Act to promulgate 
generally applicable environmental standards to limit radioactive 
materials in the general environment outside the facility. Thus, any 
ground water standard that would be promulgated as part of a revision 
of 40 CFR part 190 would be limited to application of these limits 
outside the facility boundary. The NRC's 2010 Groundwater Task Force 
identified contamination in the aquifers beneath several nuclear power 
plants, but found that most of the contamination had not left the 
boundaries of the facility. While the Agency would hope that no 
contamination is emitted from nuclear fuel cycle facilities, we realize 
that this statement is a goal and may not reflect actual operating 
facilities. However, the Agency believes that it would be prudent to 
include limits to protect against migration of the contamination 
outside the fence line. Including a ground water standard would also 
bring the regulation more in line with other Agency regulations and 
policy goals.
    Surface water. Industrial wastewater discharges to surface waters 
are generally prohibited under Section 301 of the Federal Water 
Pollution Control Act (known as the ``Clean Water Act'' or ``CWA''). 
Under Section 402 of the Act, however, a point source may be authorized 
to discharge pollutants into waters of the United States by obtaining a 
permit. These permits, which are issued by the EPA or a state that has 
an EPA-approved permit program generally provide two types of controls: 
(1) Technology-based limitations (based on the technological and 
economic achievability); and (2) water quality-based limitations (to 
achieve compliance with water quality standards). For most major 
industries, including the Primary Industrial Categories listed in 40 
CFR part 122, Appendix A, the Agency has developed Effluent Limitations 
Guidelines (ELGs), pursuant to sections 301(b) and 304 of the CWA, 
which set the technology-

[[Page 6522]]

based limits for discharges from such industrial categories. Any CWA 
Section 402 permit for a facility with applicable ELGs would be 
required to include limits prescribed by those regulations. With the 
exception of discharges from the ``Uranium, Radium and Vanadium Ores'' 
subcategory of the ``Ore Mining and Dressing Point Source'' category 
(40 CFR part 440, Subpart C), technology-based limitations for 
radionuclides associated with industrial discharges have not been 
established in the existing ELGs. The ``Steam Electric Power Generating 
ELGs'' (40 CFR part 423) apply to wastewater discharges from plants 
primarily engaged in the generation of electricity for distribution and 
sale which results primarily from the use of nuclear or fossil fuels in 
conjunction with a steam-water thermodynamic cycle. Those ELGs do not 
include limitations for radionuclides. However, where an ELG does not 
apply to certain waste streams or pollutants discharged by an 
industrial discharger, the permitting authority must establish 
technology-based effluent limits on a case-by-case, best professional 
judgment basis. (40 CFR 125.3 (c)(3)).
    CWA Section 303 directs states to adopt standards for the 
protection of water quality, including human health and aquatic life 
uses. In most cases where states have adopted water quality criteria 
for radionuclides, those criteria are intended to protect human health 
uses such as drinking water. Several states have also adopted 
radionuclide standards for livestock watering and narrative 
radionuclide standards for protection of wildlife and aquatic life. 
When a discharge is found to have a reasonable potential to cause or 
contribute to an exceedance of a state water quality criterion 
established under their standards, CWA Section 402 permits must include 
limitations intended to protect that standard (see 40 CFR 
122.44(d)(1)).
    The NRC's regulations governing the design of effluent control 
systems at nuclear power plants are provided in General Design 
Criterion 60, ``Control of Releases of Radioactive Materials to the 
Environment'' of Appendix A, ``General Design Criteria for Nuclear 
Power Plants'' in 10 CFR part 50. The criterion is to provide a ``means 
to control suitably the release of radioactive materials'' to the 
environment. NRC regulations in 10 CFR part 50, Appendix I provide 
numerical guidance that limit releases of radioactive material to ``As 
Low As [is] Reasonably Achievable'' (ALARA) and meet the criteria to 
control releases suitably. These Appendix I guides become requirements 
that are incorporated in the nuclear power plant operating licenses, 
and are consistent with EPA standards at 40 CFR part 190.
    During nuclear power plant operations, 10 CFR 20.1406, 
``Minimization of Contamination'' requires that all licensees, to the 
extent practical, conduct operations to minimize the introduction of 
residual radioactivity into the site, including the subsurface. Also, 
10 CFR 20.1501, ``general'' (radiological surveys) require licensees to 
perform subsurface surveys (i.e., soil and ground water surveys) to 
identify residual radioactivity. For decommissioning and license 
termination requirements, NRC establishes cleanup criteria in Subpart E 
of 10 CFR part 20, ``Radiological Criteria for License Termination'' 
that are consistent with EPA standards at 40 CFR part 190.
5. Questions for Public Comment
    The Agency is seeking input on the following aspects of this issue:
    a. If a ground water protection standard is established in the 
general environment outside the boundaries of nuclear fuel cycle 
facilities, what should the basis be and how should it be implemented?
    b. Are additional standards aimed at limiting surface water 
contamination needed?
6. Technical support documents and background information
    Several of the issues surrounding the establishment of ground water 
protection standards for radionuclides have been discussed and 
addressed by the Agency in previous rulemaking efforts, as well as in 
guidance documents published or available from the Agency. The notable 
citations have been included in the references for this document. See 
reference numbers 9, 10, 13,14,15,16, 29 and 30.

E. Issue 5: Spent Nuclear Fuel and High-Level Radioactive Waste 
Storage. How, if at all, should a revised rule explicitly address 
storage of spent nuclear fuel and high-level radioactive waste?

1. Why is this issue important?
    When the existing rule was issued, storage of radioactive materials 
at nuclear fuel cycle facilities was not explicitly identified as an 
activity covered by the standards. Some storage was expected as part of 
operations, but the issue did not seem to merit particular attention. 
Greater attention has been given to storage in recent years, 
particularly for spent nuclear fuel at power plant sites. In the 1970s, 
extensive reprocessing of spent nuclear fuel was envisioned, and 
disposal capacity was expected to be available, precluding the need to 
store spent nuclear fuel or other wastes at power plant sites for 
extended periods of time. However, interim storage of spent nuclear 
fuel, especially on site at nuclear power plants, has become the norm 
and for longer time periods than originally expected. We are now 
considering whether the prospect of extended storage warrants 
additional provisions to clarify how the standards would be implemented 
over the extended storage period.
    In addition, in reviewing the requirements in 40 CFR part 190 as 
they apply to spent nuclear fuel storage, we have realized that the 
applicability of the standards is not clear with respect to its 
relationship with 40 CFR part 191, which also contains provisions that 
address spent nuclear fuel storage. Given the greater interest in spent 
nuclear fuel storage, we are considering whether it is useful and 
appropriate to clarify, especially with respect to 40 CFR part 191, the 
applicability of 40 CFR part 190 to spent nuclear fuel storage 
operations at facilities in the uranium fuel cycle and to dedicated 
spent nuclear fuel storage facilities.
2. What does 40 CFR part 190 say? What was the technical basis?
    The regulation at 40 CFR part 190 did not directly address storage 
activities at nuclear fuel cycle facilities. At that time, some storage 
of radioactive materials was occurring at various nuclear fuel cycle 
facilities as part of their normal operations. It was assumed that the 
spent nuclear fuel was to be stored in pools for cooling for about 18 
months, following which it would be collected and transported to 
reprocessing plants to be recycled for additional energy generation 
(Draft Environmental Statement, 1975). A reprocessing facility would 
necessarily require some storage for both the input and output of its 
processes (e.g., spent nuclear fuel and high-level radioactive waste) 
to ensure efficient industrial operation. Given these conditions, and 
the fact that storage was not excluded from coverage in the current 
standard--whereas several other activities were exempted, including 
mining, transportation and disposal--we believe it is reasonable that 
any storage incidental to operations at a nuclear fuel cycle facility 
should be covered by 40 CFR part 190.
    Similar ambiguity exists regarding whether dedicated storage 
facilities are covered by 40 CFR part 190. Whether or not such storage 
facilities fall within

[[Page 6523]]

this category is not addressed in the rule and long-term storage of 
spent nuclear fuel was not analyzed during the rule development.
3. What has changed and how are those changes important?
    Some waste storage practices now in place were not anticipated when 
40 CFR part 190 was first issued. The most significant of these involve 
spent nuclear fuel. With no nuclear fuel reprocessing occurring and no 
disposal facility opened, spent nuclear fuel is being kept at nuclear 
power plants--in steel-lined, concrete pools or basins filled with 
water (spent nuclear fuel pools) or in massive, airtight steel or 
concrete-and-steel canisters, casks and vaults (spent nuclear fuel 
storage casks or dry cask storage)--awaiting national policy decisions 
and programs on reprocessing and ultimate disposal.
    The President's Blue Ribbon Commission on America's Nuclear Future 
summarizes the current storage situation succinctly: ``Storage [of 
spent nuclear fuel (SNF) at power plants] is not only playing a more 
prominent and protracted role in the nuclear fuel cycle than once 
expected, it is the only element of the back end of the fuel cycle that 
is currently being deployed on an operational scale in the United 
States. In fact, much larger quantities of spent nuclear fuel are being 
stored for much longer periods of time than policymakers envisioned. . 
. .'' (BRC Final Report, January 2012, p.33). The Commission's final 
report also recommends the development of one or more consolidated 
interim storage facilities for spent nuclear fuel (see BRC Final 
Report, January 2012, p. 32), which would join a number of existing 
independent spent nuclear fuel storage installations (ISFSIs) primarily 
at existing and decommissioned nuclear power plants. The 
Administration's Strategy for the Management and Disposal of Used 
Nuclear Fuel and High-Level Radioactive Waste (January 2013) is for the 
Administration, with the appropriate authorizations from Congress and 
with enactment of required legislation, to implement a program over the 
next 10 years that:
     Sites, designs and licenses, constructs and begins 
operations of a pilot interim storage facility by 2021with an initial 
focus on accepting used nuclear fuel from shut-down reactor sites.
     Advances toward the siting and licensing of a larger 
interim storage facility to be available by 2025 that will have 
sufficient capacity to provide flexibility in the waste management 
system and allows for acceptance of enough used nuclear fuel to reduce 
expected government liabilities.

(Department of Energy ``Strategy for the Management and Disposal of 
Used Nuclear Fuel and High-Level Radioactive Wastes'', 2013, p. 2). 
Thus, the foreseeable future holds the potential for storage of 
significant quantities of spent nuclear fuel--more than envisioned in 
1977--at power plants and perhaps at consolidated facilities designed 
and devoted to that purpose.
    Currently, the NRC is updating its ``Waste Confidence'' rule to 
address feasibility of continued storage until a repository is 
available. Since storage has become a more prominent part of nuclear 
power plant operations in recent years and a topic of greater concern 
to the public, the Agency believes it is worthwhile to consider whether 
a revised rule should address the topic more directly.
4. What policies and approaches are relevant?
    Some storage activities--at a minimum, storage of spent nuclear 
fuel and high-level radioactive waste at disposal facilities--are quite 
clearly covered under EPA's requirements in 40 CFR part 191, 
``Environmental Radiation Protection Standards for Management and 
Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive 
Wastes.'' However, the applicability is described quite broadly: Those 
standards address ``management . . . and storage of spent nuclear fuel 
. . . at any facility regulated by the Nuclear Regulatory Commission or 
by Agreement States, to the extent that such management and storage 
operations are not subject to the provisions of part 190 of title 40.'' 
(40 CFR 191.01) The statement could be construed to apply to facilities 
beyond disposal facilities, including at nuclear power plants.
    In practice, therefore, the language ensures full coverage of spent 
nuclear fuel storage--regardless of which activities are deemed to fall 
under which rule--since any activity not covered under the uranium fuel 
cycle should be covered under 40 CFR part 191. Further, the dose limits 
in 40 CFR part 191 apply to combined doses from storage activities 
covered under both rules (40 CFR 191.03(a)). The applicable NRC 
regulations also take into account multiple co-located or nearby 
sources and activities, and apply dose limits for the public that are 
consistent with both 40 CFR part 190 and the storage provisions of 40 
CFR part 191. NRC storage requirements apply to spent nuclear fuel, 
high-level radioactive waste and certain reactor-related low-level 
radioactive waste at stand-alone facilities as well as some on-site 
storage at power plants (10 CFR part 72).
5. What aspects of the issue are most important and what options might 
be considered to address this issue in revised standards?
    The evaluation and licensing of spent nuclear fuel storage--on site 
at nuclear power plants and at other storage facilities--has been 
implemented by the NRC. The NRC has taken steps to improve the security 
and safety of storage in recent years and is further evaluating what 
improvements can be made in light of the events in Fukushima. (See 
BRC's Final Report, p. 46) However, we recognize that the volume of 
spent nuclear fuel now being stored--and expected to be stored in 
coming decades--is much greater than what was expected to be entailed 
in the operation of nuclear power plants and perhaps also at other 
facilities. If the Agency decides to revise 40 CFR part 190, it is 
reasonable to ask whether such storage operations should be considered 
part of the fuel cycle under these standards (instead of 40 CFR part 
191), as well as whether additional technical provisions are needed to 
protect the public from potential exposures from such activities.
    We believe that the simplest approach would be to clarify that the 
nuclear fuel cycle standards cover storage operations at nuclear fuel 
cycle facilities--likely including interim storage facilities--under 40 
CFR part 190. In essence, it would specify that the ``fuel cycle'' ends 
only when the spent nuclear fuel reaches a permanent disposal facility. 
Clarifying coverage under 40 CFR part 190 would also ensure that 
updated dosimetry and science in any revised rule would be applied to 
storage operations not conducted at disposal facilities, especially if 
40 CFR part 191 is not revised within a comparable time frame.
    If a revised nuclear fuel cycle rule were to explicitly cover 
storage, an additional question is whether further requirements need to 
be instituted to address the long-term aspects of storage now 
envisioned. It is important to note that the existing EPA and NRC 
regulations discussed in this section are aimed at management and 
storage operations. With extended storage (60 years or more beyond the 
licensed operating period), there is the possibility that future 
degradation of dry casks or repackaging could result in additional 
exposures or even releases of radioactive material. A clarification 
regarding the coverage of EPA's nuclear

[[Page 6524]]

fuel cycle regulations would provide additional incentive to monitor 
storage operations to take the necessary measures to ensure continuing 
compliance. We believe that such a clarification would not require 
assessment of future storage performance, nor would it inform policy 
decisions on whether long-term storage should be pursued. We believe 
that any storage operation would need to meet the same regulatory 
requirements whether it be during licensing, or at the end of its post-
closure life, so that additional technical requirements should not be 
necessary. In this case, actual changes to 40 CFR part 190 text could 
be limited to applicability and/or in the definitions.
6. Questions for Public Comment
    a. How, if at all, should a revised rule explicitly address on-site 
storage operations for spent nuclear fuel?
    b. Is it necessary to clarify the applicability of 40 CFR part 190 
versus 40 CFR part 191 to storage operations? Should the Agency clarify 
the scope of 40 CFR part 190 to also cover operations at separate 
facilities (off-site) dedicated to storage of spent nuclear fuel (i.e., 
should we clarify the definition of the ``nuclear fuel cycle'' to 
include all management of spent nuclear fuel up until the point of 
transportation to a permanent disposal site)?

F. Issue 6: New Nuclear Technologies--What new technologies and 
practices have developed since 40 CFR part 190 was issued, and how 
should any revised rule address these advances and changes?

1. Why is this issue important?
    The existing standard, as well as any potential revised standard, 
applies to nuclear power operations. Since the promulgation of the 
existing rule, new technologies and processes have been developed.
2. What does 40 CFR part 190 say? What was the technical basis?
    The existing rule was developed based on aspects of the nuclear 
energy industry that were in existence in the early 1970s. The 1976 FES 
stated: ``In the United States the early development of technology for 
the nuclear generation of electric power has focused around the light-
water-cooled nuclear reactor. For this reason the proposed standards 
and this statement will consider only the use of enriched uranium-235 
as fuel for the generation of electricity.'' (Final Environmental 
Statement, 1976, Vol. 1, p. 3) Thus, the existing standards apply 
specifically to the uranium fuel cycle.
    The 1976 FES stated: ``The final part (of the uranium fuel cycle) 
consists of fuel reprocessing plants, where the fuel elements are 
mechanically and chemically broken down to isolate the large quantities 
of high-level radioactive wastes produced during fission for permanent 
storage and to recover substantial quantities of unused uranium and 
reactor-produced plutonium.'' (Final Environmental Statement, 1976. 
Vol. 1, p. 4)
    The technical basis for the existing standard anticipated increases 
in nuclear power generation. The 1975 Draft Environmental Statement 
stated on p. 4: ``. . . well over 300,000 megawatts of nuclear electric 
generating capacity based on the use of uranium fuel will exist within 
the next 20 years or by 1997. . . . This increase will require a 
parallel growth in a number of other activities that must exist in 
order to support uranium-fueled nuclear reactors.'' Furthermore, the 
DES (p. 5) stated: ``This technical analysis assessed the potential 
health effects associated with each of the various types of planned 
releases of radioactivity from each of the various operations of the 
fuel cycle and the effectiveness and costs of the controls available to 
reduce such effluents.''
3. What has changed and how are those changes important?
    Although more than 30 years have passed since the 1976 FES first 
described the state of the industry for which 40 CFR part 190 applies, 
many of the concepts remain the same. However, the status of several of 
the nuclear technologies has changed if one considers the international 
experience. This section will briefly discuss the nuclear technologies 
currently under consideration in the context of whether the Agency 
considers the technology as pending, and whether it merits revising 
existing regulations.
    The 1976 FES stated the following: ``There are, in all, three fuels 
available to commercial nuclear power. These are uranium-235, uranium-
233 and plutonium-239.'' (Final Environmental Statement, 1976, Vol. 1, 
p.3) However, fuels produced from the naturally occurring thorium-232 
isotope are possible and are currently being considered internationally 
for use in reactors. When used as a fuel for a nuclear reaction, 
thorium is transmuted to uranium-233; however, conventional 
nomenclature has termed this reaction as the thorium fuel cycle. 
Although thorium-232 based fuel would be part of the nuclear fuel 
cycle, some in the industry may argue that this reaction, and the 
processes considered part of this fuel cycle, would not technically be 
covered by the Subpart B provisions in 40 CFR part 190 for the 
``Uranium Fuel Cycle,'' and thus there are no applicable limits for the 
thorium fuel cycle. Additionally, for plutonium based fuels and their 
inclusion under 40 CFR part 190, the FES only stated that some 
commercial use of recycled plutonium in light-water cooled reactors is 
proposed for the near future.
    Several new nuclear power processing technologies have been 
licensed by the NRC and other technologies are being explored. The 
technologies analyzed by the Agency are included in the table below.

              Table 1--Summary of New Nuclear Technologies
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Advanced Light-water Reactor         AP1000; ABWR; ESBWR; US EPR; US
 Designs \16\.                        APWR.
Fuel Reprocessing Designs \17\.....  Aqueous; Electrochemical; OREOX.
Advanced Reactor Concept \18\......  MOX-PWR; MOX-BWR; Thorium-PWR; \19\
                                      Thorium-BWR; Heavy Water; Gas-
                                      Cooled; Sodium Fast.
------------------------------------------------------------------------

    In the above table, the MOX-PWR, MOX-BWR, Thorium-PWR and Thorium-
BWR are light-water reactors

[[Page 6525]]

(LWRs) that would operate with either mixed oxide (i.e., plutonium as 
well as uranium) or thorium fuels. The heavy water, gas-cooled, and 
sodium fast reactor concepts do not use light water for their moderator 
and/or coolant: heavy-water reactors (HWRs) use deuterium oxide (D2O) 
as the neutron flux moderator and can use either heavy water or light 
water as coolant (the Canada Deuterium-Uranium reactor (CANDU) is 
probably the most widely used heavy water reactor). Gas-cooled reactors 
usually use graphite as their moderator, and usually use helium as 
coolant, but can also use carbon dioxide. Finally, sodium fast reactors 
differ from LWRs. In a fast reactor, the fission chain reaction is 
sustained by fast neutrons, and thus does not need a neutron moderator. 
Also, because water acts as a neutron moderator, it is not usually used 
as a coolant in a fast reactor; rather, the coolant is a gas or a 
liquid metal, such as sodium or lead.
---------------------------------------------------------------------------

    \16\ Advanced Light-water Reactor Designs are light-water 
reactor concepts with formal designs either approved or under review 
by the Nuclear Regulatory Commission.
    \17\ Fuel Reprocessing Designs are designs for reprocessing 
spent nuclear fuel using various chemical and mechanical reduction 
techniques.
    \18\ In the context of this table, Advanced Reactor Concepts are 
designs where the concept is available, but no U.S. designs have 
been approved for commercialization purposes.
    \19\ Thorium fuels have been used in the past both in small 
scale reactors in the U.S. (Fort St. Vrain and Peach Bottom), and 
overseas. Several countries are renewing efforts to use thorium as 
the base fuel for new reactors with India making new thorium 
reactors a major goal of its nuclear program.
---------------------------------------------------------------------------

    Although the list above does include some advanced reactor designs 
that are improvements to previous versions of LWRs (considered 
originally in the existing standard), these technologies may need to be 
given greater consideration in a potential revision to 40 CFR part 190 
as design details regarding effluent contaminants are developed.
    The regulation at 40 CFR part 190 specifically indicates it is 
restricted to the uranium fuel cycle for electricity production. As 
mentioned above, the use of thorium as a fuel in power reactors is 
being pursued by other countries and could also be used in the U.S. 
Thorium-232 is fertile material, that is, it cannot be used in the 
reactor directly but needs to be irradiated by neutrons in a uranium 
fuel reactor first in order to transmute it to fissile uranium-233 that 
can it be used as fuel in a reactor. As such, a thorium fuel cycle 
could also be considered as simply a variant of the uranium fuel cycle. 
However, to remove any potential ambiguity as to the limit of 40 CFR 
part 190, it may be useful to broaden the scope of 40 CFR part 190 to 
include all power generation technologies using nuclear fission.
    Another new technology class being considered for commercialization 
within the U.S. is the Small Modular Reactors (SMRs). The term SMR 
refers to the size, or amount of energy generated by these reactors. 
They have been defined by the International Atomic Energy Agency as 
nuclear reactors generating 300 MW of electricity or less. The SMRs 
under development utilize traditional LWR designs, but also envision 
non-traditional water reactor or non-water reactor designs, with the 
common feature being that of a smaller reactor. These designs would 
contain smaller amounts of fuel, thus posing smaller safety and 
associated hazards than those of traditional 1000 MW reactors or 
larger. Some small reactor designs envision placing compact reactor 
modules relatively deep underground and operating them without 
refueling for the entire plant life. Other countries have already begun 
building floating nuclear power plants based on small reactors. These 
plants can be docked at remote locations to deliver power to ground-
based installations on shore. These designs could be used for 
generating electricity in isolated areas or producing high-temperature 
process heat for industrial purposes. The NRC expects to receive 
applications for staff review and approval of some of these designs in 
the near future (see www.nrc.gov/reactors/advanced.html). As mentioned 
earlier, this class of reactors potentially utilizes varying existing 
technology concepts at a smaller scale. The Agency could consider how 
to address this class of reactors in the future, in an updated rule, 
because of its projected growth.
4. What policies and approaches are relevant?
    The Agency limited the existing standards to the uranium fuel cycle 
and to light-water reactors, based on the state of the industry at the 
time. The Agency is considering whether the existing standards need to 
be revised to address new nuclear technologies that have been developed 
or may come on line in the near future, and, if so, which technologies 
should be considered.
5. What aspects of the issue are most important and what options might 
be considered to address this issue in revised standards?
    There are a couple of key considerations in determining the 
importance of new nuclear technologies. The first consideration is that 
any potential standard revision must provide protection from radiation 
emitted from new nuclear technologies. The Agency would need to develop 
standards for any new technology being commercialized if it is not 
already covered by the existing standards. The correction may be as 
simple as a definition change, but even the definition change could 
necessitate an analysis to identify if the existing standard 
appropriately protects the public from environmental releases from the 
new technology. The analysis may also be significantly more complex if 
the new technology to be commercialized uses different radionuclides as 
a fuel and produces fission products in proportions which are different 
from those typical of LWRs. Even in the event that the fission products 
are similar in nature to those in the existing standard, the new 
technology could change the effluent concentrations of fission products 
significantly.
    An example of this would be the commercialization of the thorium 
fuel cycle. Although the thorium is transmuted to uranium-233 for 
fission, the resulting fission products are projected to have a 
different composition from those generated by uranium-235. The fuel 
requirements for the thorium fuel cycle also require higher 
concentrations of enriched uranium and/or plutonium and would 
potentially yield larger amounts of low-level wastes. The Agency may 
have to conduct a review to determine what, if any, analyses would need 
to be conducted for the thorium variant.
    The second consideration is that any potential revision must 
provide clarity on environmental requirements for new nuclear 
technologies. This is an important factor so that the industry will be 
able to properly plan and complete design criteria. The nuclear power 
industry has become more efficient, and new technologies have been 
developed for some aspects of the uranium industry. Many in the nuclear 
industry have spoken of the significant growth that may occur if 
constraints on carbon emissions come into existence.\20\ Developing 
applicable radiation protection standards for future technologies now 
could provide regulatory certainty for the nuclear industry.
---------------------------------------------------------------------------

    \20\ In response to major climate change initiatives proposed by 
Congress, the Nuclear Energy Institute has stated ``Two major 
analyses issued in 2009 of the House version of the bill (H.R. 2454) 
make the case that significant nuclear energy provisions are 
necessary to achieve U.S. greenhouse gas emission reduction goals.'' 
The Energy Information Administration issued Energy Market and 
Economic Impacts of H.R. 2454, the American Clean Energy and 
Security Act of 2009. The Environmental Protection Agency released 
EPA Analysis of the American Clean Energy and Security Act of 2009 
(H.R. 2454).
---------------------------------------------------------------------------

    We recognize that the technologies discussed above, or other 
concepts being researched, may be at different stages of development. 
Some may be relatively close to commercialization, while the horizon 
for development and adoption of others may be much longer. While we 
believe it is appropriate to be forward-looking in gathering 
information to consider as part of a rulemaking that could adequately

[[Page 6526]]

address future technologies, we acknowledge that it may be premature to 
address certain of these technologies in a rule before their potential 
implications and impacts are well understood. Therefore, the Agency 
could potentially address new technologies by using one of several 
approaches. These approaches include:
    a. Review the technologies that are available in the U.S. and 
propose potential revisions only if they are not addressed by our 
existing standard.
    b. Review technologies and anticipated near-term technologies that 
are available in the U.S. and propose revisions if these technologies 
are not addressed by our existing standard. Near-term technologies 
would have to be defined, but could be viewed as technologies 
anticipated to be commercialized within the next 10-30 years.
    c. Review internationally available and anticipated near-term 
technologies and propose revisions if they are not addressed by our 
existing standard. This approach would consider foreign technologies 
that could be adopted in the U.S.
6. Questions for Public Comment
    The Agency is seeking input on the following aspects regarding this 
issue:
    a. Are there specific new technologies or practices with unique 
characteristics that would dictate the need for separate or different 
limits and do these differences merit a reconsideration of the 
technical basis for 40 CFR part 190?
    b. Should the Agency develop standards that will proactively apply 
to new nuclear technologies developed in the future, and if so, how far 
into the future should the Agency look (near-term, mid-term, etc.)?
    c. In particular, do small modular reactors pose unique 
environmental concerns that warrant separate standards within 40 CFR 
part 190?

G. Other Possible Issues for Comment

    If revised, the Radiation Protection Standards for Nuclear Power 
Operations may also address any number of issues identified during the 
public comment period. We will consider the comments submitted in 
response to this ANPR as we consider revision of the existing 
standards.

III. What will we do with this information?

    This Advance Notice of Proposed Rulemaking is being published to 
inform stakeholders, including federal and state entities, the nuclear 
industry, the public and any interested groups, that the Agency is 
reviewing the existing standards to determine how the regulation at 40 
CFR part 190 should be updated and soliciting input on changes (if any) 
that should be made. This action is not meant to be construed as an 
advocacy position either for or against nuclear power. EPA wants to 
ensure that environmental protection standards are adequate for the 
foreseeable future for nuclear fuel cycle facilities. As noted earlier, 
we believe the existing standards remain protective of public health 
and the environment; however, we believe that the issues mentioned 
above are sufficient to warrant a review and collection of public input 
on whether some portions of the standards need to be updated.
    If the Agency does revise 40 CFR part 190, then the Agency would 
follow procedures outlined in the AEA and the APA and publish a 
proposed rule in the Federal Register. Comments received on this ANPR 
would be considered in the development of a proposed rule and would be 
used by the Agency to provide a clearer understanding of science, 
technology, or other concerns and perspectives of stakeholders. 
However, the Agency will not respond directly to comments submitted to 
this ANPR. The public would have the opportunity to submit written 
comments on any proposed rule that might be developed.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993), this is a ``significant 
regulatory action'' because the action raises novel legal or policy 
issues. Accordingly, EPA submitted this action to the Office of 
Management and Budget (OMB) for review under Executive Order 12866 and 
any changes made in response to OMB recommendations have been 
documented in the docket for this action. Because this action does not 
propose or impose any requirements, and instead seeks comments and 
suggestions for the Agency to consider in possibly developing a 
subsequent proposed rule, the various statutes and Executive Orders 
that normally apply to rulemaking do not apply in this case. Should EPA 
subsequently determine to pursue a rulemaking, EPA will address the 
statutes and Executive Orders as applicable to that rulemaking.

References

1. Blue Ribbon Commission (BRC). The President's Blue Ribbon 
Commission on America's Nuclear Future--Draft Report to the 
Secretary of Energy. Washington, DC: 2011.
2. Blue Ribbon Commission (BRC). The President's Blue Ribbon 
Commission on America's Nuclear Future--Final Report to the 
Secretary of Energy. Washington, DC: 2012.
3. Department of Energy (DOE). Strategy for the Management and 
Disposal of Used Nuclear Fuel and High-Level Radioactive Waste. 
Washington, DC: 2013.
4. Environmental Protection Agency (EPA). Environmental Radiation 
Protection Requirements for Normal Operation of Activities in the 
Uranium Fuel Cycle, Draft Environmental Statement. EPA Publication 
No. 450R75101. Washington, DC: 1975.
5. Environmental Protection Agency (EPA). ``Environmental Radiation 
Protection Standards for Nuclear Power Operations, Proposed Rule.'' 
Federal Register 40 (29 May 1975): 23420.
6. Environmental Protection Agency (EPA). 40 CFR 190 Environmental 
Radiation Protection Requirements for Normal Operation of Activities 
in the Uranium Fuel Cycle, Final Environmental Statement. EPA 
Publication No. 520/4-76-016. Washington, DC: 1976.
7. Environmental Protection Agency (EPA). Environmental Analysis of 
the Uranium Fuel Cycle, Part IV--Supplementary Analysis. EPA 
Publication No. 520/4-76-017. Washington DC: 1976.
8. Environmental Protection Agency (EPA). ``40 CFR 190, 
Environmental Radiation Protection Standards for Nuclear Power 
Operations--Final Rule.'' Federal Register 42 (13 January 1977): 
2860.
9. Environmental Protection Agency (EPA). ``40 CFR Part 191, 
Environmental Radiation Protection Standards for Management and 
Disposal of Spent Nuclear Fuel, High-Level and Transuranic 
Radioactive Waste.'' Federal Register 50 (19 September 1985): 38084.
10. Environmental Protection Agency (EPA). Protecting the Nation's 
Ground Water: EPA's Strategy for the 1990s. Washington, DC: 1991.
11. Environmental Protection Agency (EPA). High-Level and 
Transuranic Radioactive Wastes--Response to Comments for 40 CFR 191. 
Washington, DC: 1993.
12. Environmental Protection Agency (EPA). ``40 CFR Part 194, 
Criteria for the Certification and Re-Certification of the Waste 
Isolation Pilot Plant's Compliance with the 40 CFR Part 191 Disposal 
Regulations--Final Rule.'' Federal Register 61 (9 February 1996): 
5235.
13. Environmental Protection Agency (EPA). Office of Solid Waste and 
Emergency Response. Directive 9200.4-18. Washington, DC: 1997.
14. Environmental Protection Agency (EPA). Office of Solid Waste and 
Emergency Response. Directive 9200.4-23. Washington, DC: 1997.
15. Environmental Protection Agency (EPA). ``40 CFR Parts 9, 141, 
and 142, National Primary Drinking Water Regulations; Radionuclides; 
Final Rule.'' Federal Register 65 (7 December 2000): 76708.
16. Environmental Protection Agency (EPA). ``40 CFR 197, Public 
Health and Environmental Radiation Protection

[[Page 6527]]

Standards for Yucca Mountain, Nevada, Final Rule.'' Federal Register 
66 (13 June 2001): 32074.
17. Environmental Protection Agency (EPA) EPA Radiogenic Cancer Risk 
Models and Projections for the U.S. Population. EPA Publication No. 
402-R-11-001. Washington, DC: 2011.
18. Federal Radiation Council (FRC). ``Radiation Protection Guidance 
for Federal Agencies.'' Federal Register 26 (18 May 1960): 4402
19. Federal Radiation Council (FRC). ``Radiation Protection Guidance 
for Federal Agencies.'' Federal Register 26 (26 September 1961): 
9057.
20. International Commission on Radiological Protection (ICRP). 
Recommendations of the International Commission on Radiological 
Protection. ICRP Publication 26. Oxford: Pergamon Press, 1977.
21. International Commission on Radiological Protection (ICRP). 1990 
Recommendations of the International Commission on Radiological 
Protection. ICRP Publication 60. Oxford: Pergamon Press, 1991.
22. International Commission on Radiological Protection (ICRP). 
Radiation Protection Recommendations. ICRP Publication 103. Oxford: 
Pergamon Press, 2008.
23. National Research Council. Technical Bases for Yucca Mountain 
Standards. Washington DC: National Academy Press, 1995.
24. National Research Council. The Disposition Dilemma--Controlling 
the Release of Solid Materials from Nuclear Regulatory Commission-
Licensed Facilities. Washington DC: National Academy Press, 2002.
25. National Council on Radiation Protection and Measurements 
(NCRP). Principles and Application of Collective Dose in Radiation 
Protection. NCRP Report No. 121. Bethesda, MD: 1995.
26. Nuclear Regulatory Commission (NRC). ``10 CFR 50, Domestic 
Licensing of Production and Utilization Facilities.'' Federal 
Register 21 (19 June 1956): 355.
27. Nuclear Regulatory Commission (NRC). ``10 CFR 20, Standards for 
Protection Against Radiation.'' Federal Register 56 (21 May 1991): 
23360.
28. Nuclear Regulatory Commission (NRC). ``10 CFR 72, Licensing 
Requirements for the Independent Storage of Spent Nuclear Fuel, 
High-Level Radioactive Waste, and Reactor-Related Greater Than Class 
C Waste.'' Federal Register 53 (19 August 1988): 31658.
29. Nuclear Regulatory Commission (NRC). Groundwater Task Force 
Final Report. ADAMS Accession Number ML101740509. Washington, DC: 
2010.
30. Nuclear Regulatory Commission (NRC). Tritium, Radiation 
Protection Limits, and Drinking Water Standards. Rockville, MD: 
2010.

    Dated: January 24, 2014.
Gina McCarthy,
Administrator.
[FR Doc. 2014-02307 Filed 2-3-14; 8:45 am]
BILLING CODE 6560-50-P