[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Proposed Rules]
[Pages 35870-35872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15441]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 /
Proposed Rules
[[Page 35870]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 20
[Docket Nos. PRM-20-28, PRM-20-29, and PRM-20-30; NRC-2015-0057]
Linear No-Threshold Model and Standards for Protection Against
Radiation
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; notice of docketing and request for
comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has received
three petitions for rulemaking (PRM) requesting that the NRC amend its
``Standards for Protection Against Radiation'' regulations and change
the basis of those regulations from the Linear No-Threshold (LNT) model
of radiation protection to the radiation hormesis model. The radiation
hormesis model provides that exposure of the human body to low levels
of ionizing radiation is beneficial and protects the human body against
deleterious effects of high levels of radiation. Whereas, the LNT model
provides that radiation is always considered harmful, there is no
safety threshold, and biological damage caused by ionizing radiation
(essentially the cancer risk) is directly proportional to the amount of
radiation exposure to the human body (response linearity). The
petitions were submitted by Carol S. Marcus, Mark L. Miller, and Mohan
Doss (the petitioners), dated February 9, 2015, February 13, 2015, and
February 24, 2015, respectively. These petitions were docketed by the
NRC on February 20, 2015, February 27, 2015, and March 16, 2015, and
have been assigned Docket Numbers. PRM-20-28, PRM-20-29, and PRM-20-30,
respectively. The NRC is examining the issues raised in these petitions
to determine whether they should be considered in rulemaking. The NRC
is requesting public comments on these petitions for rulemaking.
DATES: Submit comments by September 8, 2015. Comments received after
this date will be considered if it is practical to do so, but the NRC
is able to assure consideration only for comments received on or before
this date.
ADDRESSES: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0057. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Email comments to: [email protected]. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington DC 20555-0001; telephone: 301-415-3781, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2015-0057 when contacting the NRC
about the availability of information for this action. You may obtain
publicly-available information related to this action by any of the
following methods:
Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0057.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS,
please contact the NRC's Public Document Room (PDR) reference staff at
1-800-397-4209, 301-415-4737, or by email to [email protected]. The
ADAMS accession number for each document referenced (if it is available
in ADAMS) is provided the first time that it is mentioned in the
SUPPLEMENTARY INFORMATION section.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2015-0057 in the subject line of your
comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. The Petitioners
On February 9, 2015, Dr. Carol S. Marcus, a Professor of Radiation
Oncology, of Molecular and Medical Pharmacology (Nuclear Medicine), and
of Radiological Sciences at the David
[[Page 35871]]
Geffen School of Medicine at the University of California-Los Angeles,
filed a petition for rulemaking with the Commission, PRM-20-28 (ADAMS
Accession No. ML15051A503). Dr. Marcus was a member of the NRC's
Advisory Committee on the Medical Uses of Isotopes from 1990 to 1994.
The petitioner indicated that ``[t]here has never been scientifically
valid support for this LNT hypothesis since its use was recommended by
the U.S. National Academy of Sciences Committee on Biological Effects
of Atomic Radiation (BEAR I)/Genetics Panel in 1956'' and that ``[t]he
costs of complying with these LNT based regulations are enormous.''
On February 13, 2015, Mr. Mark L. Miller, a Certified Health
Physicist, filed a petition for rulemaking with the Commission, PRM-20-
29 (ADAMS Accession No. ML15057A349). The petitioner indicated that
``[t]here has never been scientifically valid support for this LNT
hypothesis'' and that ``[t]he costs of complying with these LNT-based
regulations are incalculable.'' In addition, the petitioner suggests
that the use of the LNT hypothesis has ``led to persistent radiophobia
[radiation-phobia].''
On February 24, 2015, Dr. Mohan Doss, filed a petition for
rulemaking with the Commission, PRM-20-30 (ADAMS Accession No.
ML15075A200). Dr. Doss filed this petition on behalf of Scientist for
Accurate Radiation Information, whose mission is to ``help prevent
unnecessary, radiation-phobia-related deaths, morbidity, and injuries
associated with distrust of radio-medical diagnostics/therapies and
from nuclear/radiological emergencies through countering phobia-
promoting misinformation spread by alarmists via the news and other
media including journal publications.''
III. The Petition
The petitioners request that the NRC amend part 20 of title 10 of
the Code of Federal Regulations (10 CFR), ``Standards for Protection
Against Radiation,'' based on new science and evidence that contradicts
the LNT hypothesis and request that the NRC greatly simplify and change
10 CFR part 20 to take into account the ``vast literature demonstrating
no effects or protective effects at relatively low doses of
radiation.'' The NRC has determined that the petitions met the
threshold sufficiency requirements for a petition for rulemaking under
Sec. 2.802, ``Petition for rulemaking,'' and the petitions have been
docketed as PRM-20-28, PRM-20-29, and PRM-20-30.
IV. Discussion of the Petitions
A. PRM-20-28
The petitioner, Dr. Carol S. Marcus, requests that the NRC amend
its regulations in 10 CFR part 20 that are based on the LNT hypothesis.
The petitioner states that ``[t]his ultra-simplistic concept assumes
that all radiation absorbed doses, no matter how small, have a finite
probability of causing a fatal cancer.'' The petitioner further
indicates that the ``[u]se of the LNT assumption enables regulators to
feel justified in ratcheting down permissible worker and public
radiation levels, either through actual dose limits or use of the `as
low as reasonably achievable' (ALARA) principle, giving the illusion
that they are making everyone safer (and creating ever increasing
workload for themselves and their licensees).'' However, the petitioner
suggests that ``there has never been scientifically valid support for
this LNT hypothesis since its use was recommended by the U.S. National
Academy of Sciences Committee on Biological Effects of Atomic Radiation
(BEAR I)/Genetics Panel in 1956'' and that the ``costs of complying
with these LNT based regulations are enormous.''
The petitioner suggests that there is ``vast literature'' that
demonstrates that low doses of radiation have no deleterious effect,
and some studies even suggest that low doses of radiation may have
protective effects. The petitioner writes, ``[t]he literature showing
protective effects supports the concept of hormesis, in which low
levels of potentially stressful agents, such as toxins, other
chemicals, ionizing radiation, etc., protect against the deleterious
effects that high levels of these stressors produce and result in
beneficial effects (e.g., lower cancer rates).'' On May 16, 2015, the
petitioner submitted an additional reference to the NRC providing
technical information supporting her requests.\1\
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\1\ Siegel, Jeffry A., and Welsh, James S.: Does Imaging
Technology Cause Cancer? Debunking the Linear No-Threshold Model of
Radiation Carcinogenesis. Technology in Cancer Research & Treatment
1533034615578011, first published on March 30, 2015 doi:10.1177/
1533034615578011.
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The petitioner recommends the following changes to 10 CFR part 20:
(1) Worker doses should remain at present levels, with allowance of
up to 100 mSv (10 rem) effective dose per year if the doses are
chronic.
(2) ALARA should be removed entirely from the regulations. The
petitioner argues that ``it makes no sense to decrease radiation doses
that are not only harmless but may be hormetic.''
(3) Public doses should be raised to worker doses. The petitioner
notes that ``these low doses may be hormetic. The petitioner goes on to
ask, ``why deprive the public of the benefits of low dose radiation?''
(4) End differential doses to pregnant women, embryos and fetuses,
and children under 18 years of age.
B. PRM-20-29
Similarly, the petitioner, Mr. Mark L. Miller, requests that the
NRC amend its regulations in 10 CFR part 20 that are based on the LNT
hypothesis. The petitioner used much of the same information used in
Dr. Marcus' petition for rulemaking. However, Mr. Miller only requests
that the following changes be made to 10 CFR part 20:
(1) Worker doses should remain at present levels, with allowance of
up to 100 mSv (10 rem) effective dose per year if the doses are
chronic.
(2) ALARA should be removed entirely from the regulations. The
petitioner argues that ``it makes no sense to decrease radiation doses
that are not only harmless but may be hormetic.''
(3) Public doses should be raised to worker doses. The petitioner
notes that ``these low doses may be hormetic. The petitioner states,
``[l]ow-dose limits for the public perpetuates radiophobia.''
C. PRM-20-30
The petition for rulemaking was submitted by Dr. Mohan Doss, on
behalf of Scientist for Accurate Radiation Information, and ``supports
and supplements'' petition PRM-20-28. This petitioner provides
additional information suggesting that ``low-dose radiation reduces
cancer risk'' (i.e., has a hormetic [beneficial] effect) and suggests
that the ``LNT model is no longer justifiable.'' The petitioner further
states that the use of the LNT hypothesis in the NRC's regulations has
``had a major detrimental effect on public health, since they have
prevented the study of LDR [low-dose radiation] for controlling aging-
related diseases such as cancer, Alzheimer's disease, Parkinson's
disease, etc. in spite of studies showing the promise of LDR for the
diseases.'' The petitioner suggests that ``urgency of action on this
petition'' is necessary because ``any potential future accident
involving release of radioactive materials in the USA would likely
result in panic evacuation because of the LNT--model-based cancer fears
and concerns, resulting in considerable casualties and economic damage
such as have occurred in Fukushima.'' The petitioner further suggests
that the ``recognition of a threshold dose by NRC would obviate
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the need for such panic evacuations, associated casualties, and
economic harm'' when radiation is released in the environment.
For additional information, see the filed petitions for rulemaking
in ADAMS under Accession Nos. ML15051A503, ML15057A349, and
ML15075A200.
V. Conclusion
The NRC will examine the issues raised in PRM-20-28, PRM-20-29, and
PRM-20-30 to determine whether they should be considered in rulemaking.
The NRC is requesting public comments on these petitions for
rulemaking.
Dated at Rockville, Maryland, this 16th day of June, 2015.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2015-15441 Filed 6-22-15; 8:45 am]
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