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Federal Register / Vol. 44, No. 249 / Thursday, December 27, 1979 / Notices

ENVIRONMENTAL PROTECTION

AGENCY

[FRL 1292-8]

National Emission Standards for

Hazardous Air Pollutants; Addition of

Radionuclides to List of Hazardous Air

Pollutants

AGENCY: Environmental Protection

Agency.

ACTION: Addition to List of Hazardous

Air Pollutants.

SUMMARY: This notice announces the

Administrator's decision to list

radionuclides as hazardous air

pollutants under Section 112 of the

Clean Air Act.

ADDRESSES: Docket No. A-79-11,

containing material relevant to this

action, is located in the U.S.

Environmental Protection Agency,

Central Docket Section, Room WSM2903B, 401 M Street, SW, Washington,

DC. The Docket may be inspected

between 8 a.m. and 4 p.m. on weekdays,

and a reasonable fee may be charged for

copying.

FOR FURTHER INFORMATION CONTACT:

James M. Hardin, Office of Radiation

Programs (ANR-460), U.S.

Environmental Protection Agency,

Washington, D.C. 20460, telephone (703)

557--8610.

SUPPLEMENTARY INFORMATION: Section

122 of the Clean Air Act as amended in

1977 directs the Administrator of the

Environmental Protection Agency, after

notice and opportunity for public

hearing, to review all relevant

information and determine whether

emissions of radioactive pollutants will

cause or contribute to air pollution

which may endanger public health.

Therefore, the Agency published a

notice which called for relevant

information and data on radioactive air

pollutants and offered to hold a public

hearing (44 FR 11707; April 11, 1979). All

written comments received were

considered in today's decision. Copies

of these comments are to be found in the

Agency's Central Docket No. A-79-11.

None of the commentors suggested

that radioactive air pollutants do not

endanger public health. Several

commentors provided information on

the release of specific radionuclides into

the atmosphere. One commentor

requested that the comment period

remain open until completion of the

third report of the National Academy of

Sciences' Advisory Committee on the

Biological Effects of Ionizing Radiation

(BEIR). We do not believe such a delay

is appropriate because the BEIR III

Report is unlikely to change

substantially the conclusions of the first

(1972) BEIR Report regarding the

carcinogenic effects of radionuclides.

We have received a summary of the

BEIR Ill Report which supports this

opinion. If the report is completed as

scheduled, we will consider its findings

in formulating any proposed standards.

Public hearings will be held when

standards are proposed and comments

on the BEIR m Report, if it is used in

formulating the standards, will be

welcomed at that time.

One commentor requested that the

Agency hold a hearing after we make a

preliminary determination and decide

on our legal, scientific, and economic

positions so that informed public

comment is possible on these issues

before the final determination is made.

We do not believe that such a public

hearing is either required or useful. The

intent of Section 122 is to insure that the

Agency has an opportunity to consider

any information not previously

considered, or to call specific attention

to particular information on the

emissions of, and health effects from, air

pollutants that may be hazardous. In

EPA's view, Section 122 does not require

what would essentially be a proposed

listing notice and hearing. This view is

based on the language and history of

Section 122 and on the fact that a full

hearing on those topics will be available

after proposal of standards under

Section 112.

Section 112 of the Act directs the

Administrator to publish and from timeto-time to revise a list of air pollutants

which, in his judgment, probably causes,

or contributes to, an increase in

mortality or serious illness and to which

no national ambient air quality standard

applies. Within 180 days after the

inclusion of any air pollutant in the list,

the Administrator must publish

proposed regulations establishing emission standards for such a pollutant,

together with a notice of a public

hearing to be held within 30 days.

In accordance with the requirements

of Sections 122 and 112, the Agency

finds that studies of the biological

effects of ionizing radiation indicate that

exposure to radionuclides increases the

risk of human cancer and genetic

damage. Also, the Agency finds that

emission data indicate that

radionuclides are released into air from

many different natural and man-made

sources with the result that everyone is

exposed to them. Further information on

these findings is given in Appendix I

(biological effects) and Appendix II

(emission data) of this notice.

Based on this information, the

Administrator has concluded that

emission of radionuclides may

reasonably be anticipated to endanger

public health, and that radionuclides

constitute hazardous air pollutants

within the meaning of the Clean Air Act.

In making this determination, the

Administrator has consulted with the

Nuclear Regulatory Commission (NRC)

as required by Section 122. Among the

radionuclides included are those defined

by the Atomic Energy Act as source

material, special nuclear material, and

byproduct material.

In accordance with Section

112(b)(1)(A) the Administrator hereby

amends the list of hazardous air

pollutants:

List of Hazardous Air Pollutants

6. Radionuclides

Dated: November 8, 1979.

Douglas M. Castle,

Adm'nistrator.

Appendix I-Summary of Evidence

That Radionuclides are Carcinogenic

and Mutagenlc to Humans

A. EPA's Current View. An extensive

body of research has demonstrated that

carcinogenicity and mutagenicity are

associated with ionizing radiation and,

therefore, with exposure to

radionuclides. Exposure to enough

ionizing radiation increases the risk of

most forms of cancer, including

leukemia, lymphoma, and cancers of the

lung, bone, thyroid, breast, skin,

stomach, pancreas, esophagus, pharynx,

large intestines, and others. When germ

cells of the ovary or testis are exposed

to enough radiation, the risk of

mutagenesis is increased which, In turn,

may cause increased mortality and

illness in future generations. For very

low doses there is no conclusive

evidence of the risk Involved.

The relationships between specific

radiation doses and risks to health are

extremely complex. They depend on

physical parameters, such as the energy

and type of radiation (e.g., alpha, beta,

or gamma radiation), total dose, dose

distribution within the body, and dose

rate. In addition, many biological

factors, such as the specific organ

exposed, the radiosensitivity of the

individual exposed, errors that occur in

biological repair mechanisms, sex, race,

age at time of exposure, genetic

composition, and state of health, may

influence the effects of radiation. These

factors involve complex mechanisms of

interaction among biological, chemical,

and physical systems, which are further

complicated because people are also

exposed to other factors such as tobacco

smoke and industrial chemicals, which

76738
Federal Register / Vol. 44, No. 249 / Thursday, December 27, 1979 / Notices

may change the magnitude of radiation

effects.

Although there is no conclusive

evidence of the effects of very low doses

of radiation on human populations, the

Agency assumes that the effects of low

doses of radiation are proportional to

the dose received in estimating the

health impact of possible low-level

radiation protection standards. We

believe this assumption is reasonable

and prudent in the light of presently

available evidence (1).

The information used by the Agency

in formulating these estimates of the

biological effects of radiation exposure

and the relationships between radiation

dose and the effects on public health has

been summarized in publications by the

National Academy of Sciences (NAS)

(2), the United Nations Scientific

Committee on the Effects of Atomic

Radiation (UNSCEAR) (3), and the

International Commission on

Radiological Protection (ICRP) (4). These

bodies agree that high levels of radiation

cause cancer and mutations and that a

sensible regulatory approach is to

consider risk to be proportional to

radiation dose at all low doses.

B. The Basis of EPA's View. The first

human cancer attributed to external

ionizing radiation was reported in 1902

from X-ray exposures (5). By 1911, 94

cases of radiation-related skin cancer

and five cases of leukemia in man had

been reported in the literature (6).

Studies from 1910 to 1912 produced the

first reports of radiation induced

cancers in experimental animals (7, 8).

In 1921, the first association between

inhaled radionuclides and

carcinogenesis in humans was made by

Uhlig for radon exposure and lung

cancer in underground miners in the Erz

Mountains of Austria, and

Czechoslovakia (9). This association

was reaffirmed by Ludewig and

Lorenser in 1924 (10]. Swallowing

radium was shown to cause bone

necrosis (11), and in 1929, Martland and

Humphries reported the association of

swallowed radium and osteosarcoma in

occupationally exposed workers (12].

In more recent times, several studies

of human populations have conclusively

shown that sufficient exposure to

radiation increases the risk of uafty

different kinds of cancer. Among the

most significant of these are the

following:

a. Survivors of the atomic bomb

explosions at Hiroshima and Nagasaki,

Japan (13).

b. Two large groups of medical

patients given X-ray therapy or

injections of radium-224 for ankylosing

spondylitis of the spine (3).

c. Groups of women whose breasts

were exposed to X-rays during

diagnostic radiation of the thorax or

during radiotherapy for benign

conditions (3).

d. Patients medically treated with Xrays, mostly to the head and neck, for

the alleviation of otherwise benign

conditions (3).

e. Underground miners exposed to

elevated levels of radon (3).

f. Persons who ingested radium-226

either for medical purposes or in the

course of their occupations (2,3).

g. Patients injected with thorotrast

(colloidal thorium dioxide) as an x-ray

contrast medium (14,15).

h. Children exposed in utero to

diagnostic x-rays (2,3).

Extensive studies n experimental

animals, especially rodents, and studies

of cell cultures support the idea that

ionizing radiation can cause mutations.

Animal studies have shown that Ionizing

radiation can cause many types of

mutations: lethal mutations,

translocations, inversions,

nondisjunction, and point mutations

(2,3). Extrapolations of mutation rates

calculated in these studies form the

basis for estimating the genetic

(hereditary) impact of ionizing radiation

in humans (2,3).

Although genetic damage to the

children of irradiated persons has not

been identified, chromosome

aberrations in somatic cells have been

observed in persons exposed to ingested

strontium-go and radium-226 (16),

inhaled/ingested radon-222 (17),

inhaled/ingested plutonium-239 (17),

inhaled radon-222 (18), and also in

lymphocytes from atomic bomb

survivors (19) and shipyard workers at

nuclear facilities in England (20).

REFERENCES

I. United States Environmental Protection

Agency. Policy Statement on Relationship

Between Radiation Dose and Effect." March 3,

1975 (41 FR 208409, July 9,1976).

2. Advisory Committee on the Biological

Effects of Ionizing Radiations. The Effects on Populations of Exposure to Low Levels of

Ionizing Radiation. National Academy of

Sciences, Washington. D.C. (1972).

3. United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR).

Sources andEffects of Ionizing Radiation.

United Nations, New York (1977).

4. International Commission on Radiological Protection. Publication 26,

Radiation Protection. Pergamon Press, New

York (1977).

5. Frieben, A. Demonstration lines

cancroids des rechten Handruckens, das sich

nach langdauemder Einwirkung von Rontgenstrahlen entwickelthatte. Fortschr.

Gab. Rontgenstr. 6.1096 (1902) cited by Upton

(6).

6. Upton. AC. Physical Carcinogeness

Rodiation-History and Sources, pp. 387-403

in Cancer 1, F. F. Becker, editor, Plenum

Press. New York (1975).

7. Marie, P., Clunet, J. and Raulot-Lapointe.

G. Contribution a letude du developpement

des tueurs mahlnes sur les ulceres de

roentgen. BulL Assoc. Franc. Etude Cancer

3:.404 (1910) cited by UNSCEAR [3).

8. Marie, P., Clunet. J. and Raulot-Lapointe,

G. Nouveau cas de tumeurmah';ne

provoquee par une radidermite

experimentafe chez le rat blanc. Bull. Assoc.

Franc. Etude Cancer5:125 (1912) cited by

UNSCEAR (3].

9. UbMg. M. Uber den Schneeberger

Lungenkrebs. Virchows Arch. PathoL Anal

23017 (1921).

10. Ludewig. P. and Lorenser E.

Untersuchung der Gmbenluft in den

Schneeberger Gruben auf den Gehaltan an Radiumamanation. Zschr. £ Phys. 2178

(1924).

11. Hoffman. F. L Radium (Mesothorium)

Necrosis. J.A.M.A. 85:6 (1925).

12. Martland. K- S. and Hunmphries. R. E.

Osteogenic Sarcoma in Dial Painters Using

Luminous Paint. Arch. PathoL, 7:406 (1929).

13. Beebe, G. W., Kato, H. and Land. C. 

Mortot yExperence of Atomic Bomb

Survivors, 1950-1974. Life Span Study Report

8. RERF TR 1-77. Radiation Effects Research

Foundation, Japan (1977).

14. International Meeting on the Toxicity of

Thorotrast and Other Alpha-Emittirg Heavy

Elements, Lisbon. June 1977 (to be published

In Environmental Research).

15. Kaul, A. and Muth, H. Thorotrast

Kientics andRadfation Dose. Rad. and

Environm. Blophys 15:24,259 (1978).

16. Tuscany, R. and KGener, V. Poles

Euploidie vBunkach Kostn Drene osob s VnIrnliKontaminaciKektiynz

Radioisotopy Cis&. Fyslol. 2.391 (963).

17. Brandom. W. F., et al. Somatic Cell

Chromosome Changes in Humans Exposed to

n' Plutonium and=2 Radon. Contract No.

E(29-2)-3639, Progress Report July 1.1 976

through September 30,1977. Department of

Energy. Washington. D.C. (1977).

18. Pohl.Rulin& J., Fischer, P., and Pohl, E.

The Low-Level Shape of Dose Response for

Chromosome Aberrations, IAEA-SM-224/

403. Presented at International Symposium on the Late Biological Effects of lonizing

Radiation. IAEA. Vienna (197).

19. Awe, A. A., et a/. Relatonship Between

Dose and Chromosome Aberratons in

Atomic Bomb Survivors, Hiroshima and

Nagasaki. HERE TR 12-77, Radiation Effects

Research Foundation. Japan (1978].

20. Evans, H. J., Buckton K E. Hamilton, G.

E., and Carothers A. Radiation-Induced

Chromosome Aberrations in NuclearDockyard Workers Nature 227531 (February

15, 197).

Appendix U-Summary of Evidence of

Significant Public Exposure to

Radinonuclides Because of Emissions

Into the Atmosphere

Most of the radionuclides in the

atmosphere come from natural sources

(1). However, radionuclides are used or

produced in thousands of locations

76739
Federal Register / Vol. 44, No. 249 / Thursday, December 27, 1979 / Notices

throughout the United States including

national defense weaponry facilities,

nuclear power plants, industrial plants,

research and development laboratories,

and medical facilities. Fossil fuel

combustion processes, such as large

coal-fire boilers, make some

contribution to the exposure of the

general public. Certain kinds of mining

and milling also substantially increase

the local concentration of radionuclides

in the air.

Although air cleaning equipment is

usually used in these facilities, some

radionuclides are still released into the

atmoshphere and can disperse into

populated areas. In most cases the

greatest danger comes from breathing

these radionuclides, but material which

settles on soil or plants may eventually

be swallowed. Settled material may also

be blown back into the air. People living

near some facilities may also be

exposed to small levels of direct gamma

radiation from airborne or settled

radionuclides.

EPA has recently published a

preliminary evaluation of the harm

caused by emissions of radionuclides

into air in the United States (2). The

document contains a complilation of the

amount of radionuclides released into

the atmosphere from each major

category of facility known to use such

materials. It estimates both the radiation

dose to the nearest individual and to the

regional population. Using these doses,

we have estimated the additional

lifetime fatal cancer risk to individuals

and the total number of fatal cancers

induced in the surrounding population

for each year of facility operation. Risk

estimates are limited to fatal cancers

because we have less confidence in

quantitative risk estimates of genetic

effects in humans. Our current practice

is to assume that for whold body

exposure, the number of genetic health

effects, and the number of nonfatal

cancers are each about the same as the

number of deaths (3).

Sources can be conveniently divided

into three major groups: facilities

licensed by NRC and certain States

which have signed an agreement with

NRC; facilities operated and regulated

by the Department of Energy (DOE); and

facilities emitting elevated

concentrations of naturally-occurring

radionuclides. The kinds of radionuclide

emissions, estimates of dose rates, and

estimates of fatal cancer risks derived

from model facilities which are

representative of source categories are

shown in Tables 1 and 2. Table 3 shows

data derived from actual DOE facilities.

These summary tables show that

significant amounts of radionuclides are

being released by man into the

atmosphere. Such estimates shoulld be

used carefuly and with recognition that

they are highly uncertain. This

uncertainty is caused by limited data on

emissions and by the use of assumptions

in environmental transport models and

in dose models. Based on these

calculations, the highest estimated doses

received are to people near elemental

phosphorus plants. Our preliminary

dose estimates for such people give 1800

mrem/yr to the kidney, 740 mrem/yr to

the lung, and 570 mrem/yr to the bone.

People living near underground uranium

mines may be exposed to elevated

airborne concentrations of radon

daughters as high as 0.006 working

levels. (WL).

We estimate that even the individuals

who live closest to the facilities listed in

Tables 1, 2, and 3 receive doses which

are less than the present applicable

Federal Guidance as established by the

former Federal Radiation Council (4,5).

However, EPA considers the potential

risk from doses as large as those

received from many of these facilities to

be unnecessarily high. We believe that

emissions from such facilities should be

reduced to as low as reasonably

achievable levels. In specific cases, EPA

has already promulgated standards and

proposed Federal Guidance which holds

the exposure of people to levels below

that found around many of the listed

source categories. These actions include:

Drinking Water Regulations

(Radionuclides) (6), Environmental

Radiation Protection Standards for

Nuclear Power Operations (7), and

proposed Federal Guidance for Persons

Exposed to Transuranium Elements in

the Environment (8).

EPA considers its current estimates of

risk to be sufficiently accurate to

support the decision to list radionuclides

as hazardous air pollutants. However,

we will continue to improve our

preliminary estimates of how much

cancer is caused by facilities which

release radionuclides into the air.

As provided in EPA's recently

published proposed rules for regulating

airborne carcinogens (44 F.R. 58642-

58670; October 10, 1979), EPA will base

all decisions on setting standards for

radionuclide emissions on detailed risk

assessments and complete regulatory

options analyses considering the

following factors: a detailed

examination of sources of emissions of

radionuclides into air, the risks caused

by these emissions, the costs and

effectiveness of emission control

technologies, the benefits of the

activities causing the emissions, the

relationships between who is receiving

the benefits versus who is required to

accept the risks, and the possibility of

using substitutes to reduce emissions.

EPA will request public comment before

making standard-setting decisions.

REFERENCES

1. United Nations Scientific Committee on

the Effects of Atomic Radiation (UNSCEAR).

Sources and Effects of Ionizing Radiation.

United Nations, New York (1977).

2. United States Environmental Protection

Agency. Radiological Impact Caused by

Emissions of Radionuclides into Air in the

United States-fPreliminary Report (EPA 520/

7-79-006) Office of Radiation Programs, Washington, D.C. (1978). 3. U.S. Environmental Protection Agency.

Radiological Quality of the Environment in

the United States, 1977 (EPA 520/1-77-009), Office of Radiation Programs, Washington, D.C. (1977). 4. Federal Radiation Council. Background

Material for the Development qf Radiation

Protection Standards (Report No. 1).

Reprinted by the U.S. Department of Health,

Education, and Welfare, Public Health

Service, Washington, D.C. (May 13, 1900), 5. Federal Radiation Council. Background

Materialfor the Development of Radiation

Protection Standards (Report No. 2). Reprinted by the U.S. Department of Health,

Education. and Welfare, Public Health

Service, Washington, D.C. (September 1001).

0. Federal Register, Vol. 41, No. 133, pp.

28402-09 (Friday, July 9, 1970).

7. Federal Register, Vol. 42, No. 9, pp. 2858-

61 (Thursday, January 13, 1977).

8. Federal Register, Vol. 42, No. 230, pp. 60956-59 (Wednesday, November 30,1077).

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