[Federal Register Volume 60, Number 48 (Monday, March 13, 1995)]
[Proposed Rules]
[Pages 13385-13388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6069]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 20
[Docket No. PRM-20-23]
Steve Gannis, Denial of Petition for Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Denial of petition for rulemaking.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition
for rulemaking (PRM-20-23) from Steve Gannis. The petition is being
denied on the basis that the proposed action is not necessary because:
current public dose limits adequately protect the health and safety of
the public; the requirement that doses are as low as is reasonably
achievable (ALARA) provides an ample margin of safety; and the proposed
1 mrem/yr limit is not supported by the recommendations of the
International Commission on Radiological Protection (ICRP), the
National Council on Radiation Protection and Measurements (NCRP), or
Presidential guidance.
ADDRESSES: Copies of the petition for rulemaking, the public comments
received, and the NRC's letter to the petitioner are available for
public inspection or copying in the NRC Public Document Room, 2120 L
Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Charleen T. Raddatz, Office of Nuclear
Regulatory Research, U.S. Nuclear [[Page 13386]] Regulatory Commission,
Washington, DC 20555, telephone (301) 415-6215.
SUPPLEMENTARY INFORMATION:
The Petition
By letter dated January 8, 1994, Mr. Steve Gannis filed a petition
for rulemaking with the NRC. The petitioner requested that the NRC
reduce the limit for radiation dose to members of the public from the
current 100 mrem/yr to 1 mrem/yr.
As a basis for the requested action, the petitioner cited the NRC
policy statement on radiation doses that should be considered ``Below
Regulatory Concern'' (BRC)(issued July 3, 1990; FR 27522, and withdrawn
August 24, 1993; 58 FR 44610). Table 1 (July 3, 1990; 55 FR 27527 and
55 FR 27232) of that policy statement shows that if a person received
the maximum allowable dose every year of the average 70-year life-span,
he or she would have an additional 1 in 285 chance of death from cancer
as a result of that dose. The petitioner further contends that non-
fatal cancers would result at the same rate.
Public Comments on the Petition: Summary and Analysis
On April 14, 1994 (59 FR 17746), the NRC published a notice of the
receipt of a petition for rulemaking in the Federal Register.
Interested persons were invited to submit written comments concerning
the petition by June 28, 1994. The NRC received 34 letters of comment
from 30 individuals in response to the notice. Two commenters submitted
addenda to their comments which were docketed separately. These are
summarized in Table 1. Table 1.
Table 1
------------------------------------------------------------------------
Comments Category For Against
------------------------------------------------------------------------
6........... Individuals........................... 4 2
5........... Radiation Protection Professional ........ 5
Organizations Representatives.
12.......... Environmental Group Representatives... 11 1
7........... NRC Licensee Representatives.......... ........ 7
------------------------------------------------------------------------
Comments in Favor of the Petition
Several commenters in favor of the petition gave no reasons for
their support. These commenters only repeated the position in the
petition. One commenter believed that no more than 2.5 mrem/yr limit
was reasonable. One commenter said that only a zero dose limit was
acceptable. Another commenter said that having reviewed the application
for a low-level waste storage facility, it is evident that 1 mrem/yr is
achievable for that facility and, therefore, reasonable for all
facilities under NRC jurisdiction. Many of those who commented in
support of the petition stated that they were appalled that NRC would
condone the thousands of unnecessary deaths caused each year by doses
to members of the public from exposure to NRC-licensed material.
NRC Response
None of the commenters in favor of the petition presented any
information that was convincing concerning the need for a lower dose
limit for members of the public. Annual doses to members of the public
from natural and man-made sources are summarized in Table 2 (from NCRP
Reports, Numbers 92, 93, 94, and 95).
Table 2
------------------------------------------------------------------------
Average annual dose
Source --------------------
in mSv mrem
------------------------------------------------------------------------
Naturally occurring radon.......................... 2.0 200.0
Other naturally occurring.......................... 1.0 100.0
All occupational exposures......................... 0.009 0.9
Nuclear fuel cycle................................. 0.0005 0.1
Other consumer products............................ 0.1 10.0
Diagnostic medical x-rays.......................... 0.39 39.0
Nuclear medicine................................... 0.14 14.0
--------------------
Total........................................ 3.64 364.0
------------------------------------------------------------------------
Inspection data since 1982 shows that effluents and direct
radiation dose rates continue to decline. As doses to members of the
public are calculated from these, it is reasonable to assume that
public doses have continued to decline as well.
While those who live nearest to NRC-licensed facilities are in
principle allowed to receive up to the limit of 100 mrem/yr, most
receive only a small fraction of this. The reason for this is that
ALARA programs in place to supplement the dose limit result in a system
of dose control which achieves doses significantly below the limit. As
a consequence of this approach, the average dose to most members of the
public from NRC-licensed facilities is well below 1 mrem/yr. Naturally
occurring radioactivity is responsible for an average of 300 mrem/yr.
In some areas, the dose from naturally occurring radioactivity is
considerably higher (up to 900 mrem/yr according to NCRP Report No.
93). The ICRP, in its 1990 recommendations on dose limits in Report
Number 60, confirmed that there is no new biological evidence that
suggests that there should be a reduction in the limit for members of
the public. The ICRP recommendation for dose to members of the public
is 100 mrem/yr with certain provisions for deviations up to 500 mrem/
yr. The NCRP reached the same conclusions in Report Number 116.
One commenter stated that the Environmental Protection Agency (EPA)
limit for members of the public is only 10 mrem/yr. Therefore, the NRC
limit of 100 mrem/yr does not protect the health and safety of the
public. However, 10 mrem/yr is the EPA Clean Air Act limit for dose
from a single pathway of exposure; namely, the dose a member of the
public might receive from airborne releases of radioactive material
from a facility. Members of the public might receive doses from other
pathways as well, including radioactive material in food, water, on the
ground, and in the soil, and direct radiation from the facility in
which the radioactive material is stored or used. Presidential Guidance
to Federal Agencies on dose limits for Public Exposure (May 18, 1960;
25 FR 4402), signed by former President Eisenhower, recommends a value
of 500 mrem/yr for all pathways. This guidance is currently under
consideration for revision and is expected to be revised to 100 mrem/yr
from all pathways (see proposed revision published December 23, 1994
(59 FR 66414). NRC's limit of 100 mrem/yr from all pathways, from
licensed and unlicensed sources, under the control of the licensee,
including the [[Page 13387]] provision that any dose must be as low as
is reasonably achievable, has the effect of being at least as
protective as EPA regulations. In a survey conducted by the EPA to
determine if NRC licensees were releasing radioactive materials to the
environment in excess of EPA Clean Air Act limits, the EPA found that
none of the NRC licensees surveyed had airborne effluents resulting in
doses greater than 10 mrem/yr and the vast majority resulted in doses
less than 1 mrem/yr to the member of the public likely to receive the
highest dose.
Comments Opposed to the Petition
Commenters opposed to the petition presented a variety of reasons
for their opposition. Most commenters stated that some current uses of
radioactive materials could not continue under a 1 mrem/yr limit for
members of the public. Further, some of the commenters stated that it
would be impossible to demonstrate compliance with a limit so low that
it could not be measured. Many commenters stated that there would be no
significant increase in the protection of public health and safety.
Other commenters concluded that the lower limit would result in a
significant decrease in protection of the health and safety of the
public. Some commenters came to this conclusion based on the estimated
risks from effluents, waste, and radiation dose from alternate methods
for production of electric power (e.g., coal, oil). Other commenters
based the conclusion on the increased risk from surgical procedures and
alternate chemical treatments for patients now treated with radioactive
materials. Some commenters argued that economic considerations would
preclude certain uses of radioactive material such as some medical
uses. Therefore, the mortality risk from certain cancers would be much
higher without the use of radioactive materials in treatment.
Radioactive treatments performed to reduce pain and suffering in the
last months of life for many cancer patients would also have to be
stopped.
Many commenters opposed to the petition believed that the risk was
exaggerated in the petition. They stated that the risk estimate
referenced by the petitioner assumed that every individual would
receive the maximum allowable dose every year of his or her life. Some
commenters believed it inappropriate to use the conservative linear
non-threshold model to extrapolate from doses between a few thousand
mrem and millions of mrem, delivered in a fraction of a second, to the
100 mrem/yr limit. They believed it unreasonable to give no
consideration to possible repair mechanisms or to the existence of any
tolerance to radiation dose. Further, commenters contended that
licensees must demonstrate compliance with the limit for members of the
public by assuming that a member of the public is present at the
location of highest dose rate, 24 hours a day, 365 days a year. The
commenter therefore concluded that the actual risk is much smaller than
the petitioner believes.
Most commenters opposed to the petition cited the recent
recommendations of both the ICRP and the NCRP. Both organizations
recommend that dose to members of the public not exceed 500 mrem in any
one year and not average more than 100 mrem/yr. NCRP states that a dose
of 500 mrem in a year is not especially hazardous if the same group
does not receive that dose year after year.
One commenter compared 1 mrem/yr exposure to common radiation
sources. Some of the examples given were: (1) Flying from New York City
to Los Angeles exposes each passenger and crew member to 5 mrem; (2) a
one week Colorado ski trip raises your annual exposure by 11 mrem; and
(3) sleeping in bed with another person exposes each person to 0.1
mrem/yr from exposure to radioactive material in the other person's
body. This commenter argued that radiation is the most studied hazard
agent on earth. This commenter stated that after 99 years and billions
of research dollars, no statistically significant negative effects of
low levels of radiation have been shown in well controlled studies, and
in fact, some studies suggest that there may be benefits from chronic,
low level radiation exposure, possibly because, by stimulating enzyme
production, the organism is protected from damage by stronger radiation
and toxic chemicals. This commenter's argument is based, in part, on
the observation that background radiation levels in Colorado are about
twice that of the rest of the United States, yet cancer rates are tied
for the third lowest in the nation.
NRC Response
For the reasons stated as the basis for the denial, the NRC agrees
with those commenters who were opposed to the petition.
Reasons for Denial
The NRC has considered the petition, the public comments received,
and other related information and has concluded that the issues raised
by the petition are insufficient to justify rulemaking to reduce the
limit for members of the public. The following is a discussion of the
details of that conclusion.
The primary concern of the petition is the perception that the 100
mrem/yr limit for radiation exposure from radioactive sources under the
control of NRC licensees poses an unacceptable risk to the population
of the United States. In 1994, the ICRP Main Commission fully discussed
the issue of dose limits for members of the public together with the
statements to the 1994 United Nations Scientific Committee on the
Effects of Atomic Radiation (UNSCEAR). The ICRP confirmed that there
was no new biological evidence that suggested that there should be a
revision to the cancer risk estimates in ICRP Publication 60 and no
reason to revise the recommendation that the average dose over a five
year period not exceed 100 mrem/yr for members of the public (allowing
for infrequent exposures up to 500 mrem/yr). The NCRP examined the
UNSCEAR 1988 report, the report by the National Academy of Sciences/
National Research Council Committee on the Biological Effects of
Ionizing Radiation (BEIR V) (NAS/NRC, 1990), and the recommendations of
the ICRP and issued recommendations that United States regulatory
agencies establish limits for exposure to man-made radiation sources by
members of the public to an annual average not to exceed 100 mrem/yr
with allowances for infrequent exposures up to 500 mrem/yr.
The petitioner contends that the NRC limit of 100 mrem/yr doubles
the average background radiation dose to which members of the public
are exposed. In fact, the NRC system of dose control includes the ALARA
concept that doses should be controlled below the dose limits and to
levels which are as low as reasonably achievable. As a consequence, the
actual doses from licensed activities are only a very small fraction of
the annual background dose to members of the public which averages 300
mrem/yr in the United States.
The petitioner states that ``Federal Government standards on how
much cancer can be caused among the public by cancer-causing pollutants
and contaminants generally permit, at most, approximately 1 cancer per
million people.'' However, the EPA National Emission Standards for
Hazardous Air Pollutants (NESHAPS); Radionuclides (54FR51655) states
that ``a principle that accompanies these numerical goals is that the
state of art of risk assessment does not enable numerical risk
estimates to be made with comparable confidence. Therefore, judgment
must be used in [[Page 13388]] deciding how numerical risk estimates
are considered with respect to these goals.'' The NESHAPS standard for
emissions of radioactive material from NRC licensed facilities is 10
mrem/yr for the air effluent release pathway alone. While the results
of the 1993 reports to EPA have not been provided to NRC, a survey of
NRC licensed facility air emissions performed by EPA in 1992 revealed
that no NRC licensed facility surveyed exceeded that value. Almost all
of the facilities surveyed in 1992 had air effluents which resulted in
doses an order of magnitude lower for the maximally exposed
individuals.
Taking these considerations into account, with respect to reducing
the radiation dose limit to members of the public from 100 mrem/yr to 1
mrem/yr, the petition fails to recognize the net effect of the NRC's
system of dose control and the role played by the dose limit and ALARA
programs.
When these are taken into account, NRC's judgment is that the
public is adequately protected, the health risks from NRC licensed
activities are low, and no change in basic radiation protection
standards, as petitioner suggests, is warranted.
Dated at Rockville, Maryland, this 2nd day of March, 1995.
For the Nuclear Regulatory Commission.
James M. Taylor,
Executive Director for Operations.
[FR Doc. 95-6069 Filed 3-10-95; 8:45 am]
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