80 FR 35870 - Linear No-Threshold Model and Standards for Protection Against Radiation

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 80, Issue 120 (June 23, 2015)

Page Range		35870-35872
FR Document		2015-15441

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.

Federal Register, Volume 80 Issue 120 (Tuesday, June 23, 2015)

[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Proposed Rules]
[Pages 35870-35872]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 35872]]

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]
 BILLING CODE 7590-01-P

Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Proposed Rules 35871

Geffen School of Medicine at the IV. Discussion of the Petitions (3) Public doses should be raised to
University of California-Los Angeles, worker doses. The petitioner notes that
A. PRM–20–28
filed a petition for rulemaking with the ‘‘these low doses may be hormetic. The
Commission, PRM–20–28 (ADAMS The petitioner, Dr. Carol S. Marcus, petitioner goes on to ask, ‘‘why deprive
Accession No. ML15051A503). Dr. requests that the NRC amend its the public of the benefits of low dose
Marcus was a member of the NRC’s regulations in 10 CFR part 20 that are radiation?’’
Advisory Committee on the Medical based on the LNT hypothesis. The (4) End differential doses to pregnant
Uses of Isotopes from 1990 to 1994. The petitioner states that ‘‘[t]his ultra- women, embryos and fetuses, and
petitioner indicated that ‘‘[t]here has simplistic concept assumes that all children under 18 years of age.
never been scientifically valid support radiation absorbed doses, no matter how B. PRM–20–29
for this LNT hypothesis since its use small, have a finite probability of
causing a fatal cancer.’’ The petitioner Similarly, the petitioner, Mr. Mark L.
was recommended by the U.S. National
further indicates that the ‘‘[u]se of the Miller, requests that the NRC amend its
Academy of Sciences Committee on
LNT assumption enables regulators to regulations in 10 CFR part 20 that are
Biological Effects of Atomic Radiation
feel justified in ratcheting down based on the LNT hypothesis. The
(BEAR I)/Genetics Panel in 1956’’ and
permissible worker and public radiation petitioner used much of the same
that ‘‘[t]he costs of complying with these
levels, either through actual dose limits information used in Dr. Marcus’ petition
LNT based regulations are enormous.’’
or use of the ‘as low as reasonably for rulemaking. However, Mr. Miller
On February 13, 2015, Mr. Mark L. only requests that the following changes
achievable’ (ALARA) principle, giving
Miller, a Certified Health Physicist, filed the illusion that they are making be made to 10 CFR part 20:
a petition for rulemaking with the everyone safer (and creating ever (1) Worker doses should remain at
Commission, PRM–20–29 (ADAMS increasing workload for themselves and present levels, with allowance of up to
Accession No. ML15057A349). The their licensees).’’ However, the 100 mSv (10 rem) effective dose per year
petitioner indicated that ‘‘[t]here has petitioner suggests that ‘‘there has never if the doses are chronic.
never been scientifically valid support (2) ALARA should be removed
been scientifically valid support for this
for this LNT hypothesis’’ and that ‘‘[t]he entirely from the regulations. The
LNT hypothesis since its use was
costs of complying with these LNT- petitioner argues that ‘‘it makes no sense
recommended by the U.S. National
based regulations are incalculable.’’ In to decrease radiation doses that are not
Academy of Sciences Committee on
addition, the petitioner suggests that the only harmless but may be hormetic.’’
Biological Effects of Atomic Radiation
use of the LNT hypothesis has ‘‘led to (3) Public doses should be raised to
(BEAR I)/Genetics Panel in 1956’’ and
persistent radiophobia [radiation- worker doses. The petitioner notes that
that the ‘‘costs of complying with these
phobia].’’ ‘‘these low doses may be hormetic. The
LNT based regulations are enormous.’’
petitioner states, ‘‘[l]ow-dose limits for
On February 24, 2015, Dr. Mohan The petitioner suggests that there is the public perpetuates radiophobia.’’
Doss, filed a petition for rulemaking ‘‘vast literature’’ that demonstrates that
with the Commission, PRM–20–30 low doses of radiation have no C. PRM–20–30
(ADAMS Accession No. ML15075A200). deleterious effect, and some studies The petition for rulemaking was
Dr. Doss filed this petition on behalf of even suggest that low doses of radiation submitted by Dr. Mohan Doss, on behalf
Scientist for Accurate Radiation may have protective effects. The of Scientist for Accurate Radiation
Information, whose mission is to ‘‘help petitioner writes, ‘‘[t]he literature Information, and ‘‘supports and
prevent unnecessary, radiation-phobia- showing protective effects supports the supplements’’ petition PRM–20–28.
related deaths, morbidity, and injuries concept of hormesis, in which low This petitioner provides additional
associated with distrust of radio- levels of potentially stressful agents, information suggesting that ‘‘low-dose
medical diagnostics/therapies and from such as toxins, other chemicals, ionizing radiation reduces cancer risk’’ (i.e., has
nuclear/radiological emergencies radiation, etc., protect against the a hormetic [beneficial] effect) and
through countering phobia-promoting deleterious effects that high levels of suggests that the ‘‘LNT model is no
misinformation spread by alarmists via these stressors produce and result in longer justifiable.’’ The petitioner
the news and other media including beneficial effects (e.g., lower cancer further states that the use of the LNT
journal publications.’’ rates).’’ On May 16, 2015, the petitioner hypothesis in the NRC’s regulations has
submitted an additional reference to the ‘‘had a major detrimental effect on
III. The Petition
NRC providing technical information public health, since they have prevented
The petitioners request that the NRC supporting her requests.1 the study of LDR [low-dose radiation]
amend part 20 of title 10 of the Code of The petitioner recommends the for controlling aging-related diseases
Federal Regulations (10 CFR), following changes to 10 CFR part 20: such as cancer, Alzheimer’s disease,
‘‘Standards for Protection Against (1) Worker doses should remain at Parkinson’s disease, etc. in spite of
Radiation,’’ based on new science and present levels, with allowance of up to studies showing the promise of LDR for
evidence that contradicts the LNT 100 mSv (10 rem) effective dose per year the diseases.’’ The petitioner suggests
hypothesis and request that the NRC if the doses are chronic. that ‘‘urgency of action on this petition’’
greatly simplify and change 10 CFR part (2) ALARA should be removed is necessary because ‘‘any potential
20 to take into account the ‘‘vast entirely from the regulations. The future accident involving release of
literature demonstrating no effects or petitioner argues that ‘‘it makes no sense radioactive materials in the USA would
mstockstill on DSK4VPTVN1PROD with PROPOSALS

protective effects at relatively low doses to decrease radiation doses that are not likely result in panic evacuation
of radiation.’’ The NRC has determined only harmless but may be hormetic.’’ because of the LNT—model-based
that the petitions met the threshold cancer fears and concerns, resulting in
sufficiency requirements for a petition 1 Siegel, Jeffry A., and Welsh, James S.: Does considerable casualties and economic
for rulemaking under § 2.802, ‘‘Petition Imaging Technology Cause Cancer? Debunking the damage such as have occurred in
Linear No-Threshold Model of Radiation
for rulemaking,’’ and the petitions have Carcinogenesis. Technology in Cancer Research &
Fukushima.’’ The petitioner further
been docketed as PRM–20–28, PRM–20– Treatment 1533034615578011, first published on suggests that the ‘‘recognition of a
29, and PRM–20–30. March 30, 2015 doi:10.1177/1533034615578011. threshold dose by NRC would obviate

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Document Modified: 2018-02-22 11:15:31

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Petition for rulemaking; notice of docketing and request for comment.
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.
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]
FR Citation		80 FR 35870