Environmental Radiation Protection Standards for Nuclear Power Operations, 6509-6527 [2014-02307]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Proposed Rules]
[Pages 6509-6527]
From the Federal Register Online via the Government Printing 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: a-and-r-docket@epa.gov.
     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, littleton.brian@epa.gov.

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