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Citation: 44 Fed. Reg. 76738 1979

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-- The search text of this PDF is generated from uncorrected OCR text.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 ofHazardous 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 ofRadiation Programs (ANR-460), U.S. Environmental Protection Agency, Washington, D.C. 20460, telephone (703) 557--8610.
SUPPLEMENTARY INFORMATION: Section 122 ofthe Clean Air Act as amended in 1977 directs the Administrator of the Environmental Protection Agency, after notice and opportunity forpublic hearing, to review all relevant information and determine whether emissions ofradioactive 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 ofthe first (1972) BEIR Report regarding the carcinogenic effects ofradionuclides. We have received a summary ofthe 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, ifit is usedin formulating the standards, will be welcomed at that time.

One commentor requested thatthe 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 ofstandards under Section 112.

Section 112 ofthe Act directs the Administrator to publish and from timeto-time to revise a list ofair pollutants which, in hisjudgment, 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 ofany 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 ofthe biological effects ofionizing radiation indicate that exposure toradionuclides increases the risk ofhuman 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 inAppendix I (biological effects) and Appendix II (emission data) ofthis notice.

Based on this information, the Administrator has concluded that emission ofradionuclides may reasonably be anticipated to endanger public health, and that radionuclides constitute hazardous air pollutants within the meaning ofthe 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 ofhazardous air pollutants:

List ofHazardous 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 CurrentView. An extensive body ofresearch 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 ofcancer, including leukemia, lymphoma, and cancers ofthe 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. Forvery low doses there is no conclusive evidence ofthe 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 ofradiation (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 ofthe individual exposed, errors that occur in biological repair mechanisms, sex, race, age at time of exposure, genetic composition, and state ofhealth, may influence the effects ofradiation. 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 76738Federal Register / Vol. 44, No. 249 / Thursday, December 27, 1979 / Notices

may change the magnitude ofradiation effects.

Although there is no conclusive evidence of the effects ofvery low doses ofradiation on human populations, the Agency assumes that the effects oflow doses ofradiation are proportional to the dosereceived in estimating the health impact ofpossible low-level radiation protection standards. We believe this assumption is reasonable and prudent in the light ofpresently available evidence (1).

The information used by the Agency in formulating these estimates ofthe biological effects ofradiation exposure and the relationships between radiation dose and the effects onpublic health has been summarized in publications by the National Academy of Sciences (NAS) (2), the United Nations Scientific Committee on the Effects ofAtomic Radiation (UNSCEAR) (3), and the International Commission on Radiological Protection (ICRP) (4). These bodies agree that high levels ofradiation

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. TheBasis 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 ofradiation-related skin cancer and five cases ofleukemia in man had been reported in the literature (6). Studies from 1910 to 1912 produced the first reports ofradiation induced

cancers in experimental animals (7,8). In1921, the first association between inhaled radionuclides and carcinogenesis inhumans was made by Uhlig forradon exposure and lung

cancer in underground miners in the Erz Mountains ofAustria, and Czechoslovakia (9). This association

was reaffirmed by Ludewig and Lorenser in 1924 (10]. Swallowing radium was shown to cause bone necrosis (11), andin 1929, Martland and Humphries reported the association of swallowed radium and osteosarcoma in occupationally exposed workers (12].

In more recent times, several studies ofhuman populations have conclusively shown that sufficient exposure to radiation increases the risk of uafty different kinds of cancer. Among the

most significant ofthese are the following:

a. Survivors of the atomic bomb explosions at Hiroshima and Nagasaki, Japan (13).

b.Two large groups ofmedical patients given X-ray therapy or injections of radium-224 for ankylosing spondylitis ofthe spine (3). c. Groups ofwomen whose breasts

were exposed to X-rays during diagnostic radiation of the thorax or during radiotherapy forbenign conditions (3).

d.Patients medically treated with Xrays, mostly to the head and neck, for the alleviation ofotherwise benign conditions (3).

e. Underground miners exposed to elevated levels ofradon (3).

f. Persons who ingested radium-226 either for medical purposes or in the

course oftheir 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 ofcell 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 ofmutation rates calculated in these studies form the basis for estimating the genetic (hereditary) impact ofionizing radiation in humans (2,3).

Although genetic damage to the children ofirradiated 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 onRelationship Between Radiation DoseandEffect." March 3, 1975(41 FR 208409, July 9,1976).

2. Advisory Committee on the Biological Effects ofIonizing Radiations. The Effects on Populations of

ExposuretoLowLevels of IonizingRadiation.National Academy of Sciences, Washington. D.C. (1972).

3.United Nations Scientific Committee on theEffects ofAtomic Radiation (UNSCEAR). SourcesandEffectsof IonizingRadiation. United Nations, New York (1977).

4. International Commission on Radiological Protection. Publication 26, Radiation Protection. PergamonPress, New York (1977).

5. Frieben, A. Demonstration lines cancroidsdesrechten Handruckens, dassich nachlangdauemder Einwirkungvon Rontgenstrahlenentwickelthatte.Fortschr. Gab. Rontgenstr. 6.1096 (1902) cited by Upton (6). 6. Upton.AC. PhysicalCarcinogeness Rodiation-History and Sources,pp. 387-403 in Cancer1,F. F.Becker, editor,Plenum Press. New York (1975).

7. Marie, P., Clunet, J. and Raulot-Lapointe. G. Contribution a letudedu developpement des tueurs mahlnessur les ulceresde roentgen.BulL Assoc.Franc.Etude Cancer 3:.404 (1910) cited by UNSCEAR [3).

8. Marie, P.,Clunet. J.and Raulot-Lapointe, G. Nouveaucasde tumeurmah';ne
provoquee par uneradidermite experimentafechezleratblanc.Bull. Assoc. Franc.Etude Cancer5:125 (1912) cited by UNSCEAR (3].

9. UbMg. M. Uberden Schneeberger Lungenkrebs.Virchows Arch. PathoL Anal 23017 (1921).

10.Ludewig. P. and Lorenser E. Untersuchung derGmbenluftinden Schneeberger Grubenauf den Gehaltanan 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 SarcomainDial PaintersUsing LuminousPaint. Arch. PathoL, 7:406(1929). 13. Beebe, G.W., Kato,H. and Land. C. Mortot yExperenceof AtomicBomb Survivors,1950-1974. Life Span Study Report 8. RERFTR 1-77. Radiation Effects Research Foundation, Japan (1977).

14. International Meeting on theToxicity of Thorotrast and Other Alpha-Emittirg Heavy Elements, Lisbon. June 1977 (tobe published InEnvironmental Research).

15. Kaul, A. and Muth, H. Thorotrast KienticsandRadfation Dose.Rad. and Environm. Blophys 15:24,259(1978).

16. Tuscany, R.and KGener, V.Poles EuploidievBunkachKostn Dreneosobs VnIrnliKontaminaciKektiynz RadioisotopyCis&. Fyslol. 2.391 (963). 17. Brandom. W. F., etal. SomaticCell ChromosomeChangesinHumans Exposedto n' Plutoniumand=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. TheLow-Level Shapeof Dose Response for Chromosome Aberrations,IAEA-SM-224/ 403. Presented at International Symposium on the Late Biological Effects oflonizing Radiation. IAEA. Vienna (197).

19. Awe, A. A., eta/. Relatonship Between DoseandChromosomeAberratons in AtomicBombSurvivors, 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 inNuclearDockyardWorkers Nature 227531 (February 15,197).
Appendix U-Summary ofEvidence of Significant Public Exposure to Radinonuclides Because ofEmissions Into the Atmosphere

Most ofthe radionuclides in the atmosphere come from natural sources (1). However, radionuclides areused or produced in thousands oflocations 76739Federal 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 ofthe general public. Certain kinds of mining and milling also substantially increase the local concentration ofradionuclides 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 ofdirect gamma radiation from airborne or settled radionuclides.

EPA has recently published a preliminary evaluation ofthe harm caused by emissions ofradionuclides into air in the United States (2). The document contains a complilation of the
amount ofradionuclides released into the atmosphere from each major category offacility 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 offacility operation. Risk estimates are limited to fatal cancers because we have less confidence in quantitative risk estimates ofgenetic effects in humans. Our current practice is to assume that for whold body exposure, the number ofgenetic health effects, and the number ofnonfatal

cancers are each about the same as the number ofdeaths (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 ofEnergy (DOE); and facilities emitting elevated concentrations ofnaturally-occurring radionuclides. The kinds ofradionuclide emissions, estimates of dose rates, and estimates of fatal cancer risks derived from model facilities which are representative ofsource categories are shown in Tables 1 and 2. Table 3 shows data derived from actual DOE facilities.

These summary tables show that significant amounts ofradionuclides 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 ofassumptions 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 ofradon 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 3receive 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 ofthese 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 ofpeople to levels below that found around many ofthe 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 (44F.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 ofthe 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 ofAtomic Radiation (UNSCEAR). Sources and Effects of IonizingRadiation. United Nations, New York (1977).

2.United States Environmental Protection Agency. Radiological Impact Caused by Emissionsof RadionuclidesintoAirin the United States-fPreliminary Report (EPA 520/ 7-79-006) Office ofRadiation Programs, Washington, D.C. (1978).

3.U.S. Environmental Protection Agency. Radiological Qualityofthe Environmentin the UnitedStates,1977 (EPA520/1-77-009), Office ofRadiation Programs, Washington, D.C. (1977).

4. Federal Radiation Council.Background Material for theDevelopment qf Radiation Protection Standards(Report No. 1). Reprinted by theU.S. Department ofHealth, Education, and Welfare, Public Health Service, Washington, D.C. (May 13, 1900),

5.Federal Radiation Council.Background Materialfor theDevelopmentof Radiation Protection Standards(Report No. 2). Reprinted by the U.S. Department ofHealth, 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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