Steve Gannis, Denial of Petition for Rulemaking

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Regulatory Concern'' (BRC)(issued July 3, 1990; FR 27522, and withdrawn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

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Comments Category For Against

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6........... Individuals........................... 4 2

5........... Radiation Protection Professional ........ 5

Organizations Representatives.

12.......... Environmental Group Representatives... 11 1

7........... NRC Licensee Representatives.......... ........ 7

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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

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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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