Amicus Curiae Brief — Mallinckrodt, Inc. v. Bennett

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SAMUEL F. BENNETT, et ai.,

Respendents.

L. Manning Muntzing*

Robert J. Ross

James R. Shoemaker

Doub & Muntzing, Chartered

1875 Eye Street, N.W.

Suite 775

; Washington, D.C. 20006

Of Counsel: (202) 467-6460

$55 N. Kensington Avenue se angi

La Grange Park, IL 60525

(312) 352-4411 *Ceunsel of Record

nel

(i)

IN THE

Supreme Court of the United States

OCTOBER TERM, 1985

No. 85-1710

MALLINCKRODT, INC.,

Petitioner,

Vv.

SAMUEL F. BENNETT, et ai.,

Respondents.

MOTION FOR LEAVE TO FILE

AS AMICI CURIAE IN

SUPPORT OF PETITIONER

The Society of Nuclear Medicine (the “Society”) and the

American Nuclear Society (“ANS”) respectfully move pur-

suant to Rule 36.1. of the Rules of this Court for leave to

file a joint brief as amici curiae in support of the Petition

for Certiorari in the above captioned case. The Society

and ANS make this motion because the respondents refus-

ed to provide their written consent to the Society and ANS

to participate in this case as amici curiae in support of the

petitioner, Mallinckrodt, Inc. The Society and ANS sup-

port Mallinckrodt’s Petition for Certiorari asking this

Court to review the decision of the Missouri Court of Ap-

peals that the respondents’ claims for monetary damages

arising out of Mallinckrodt’s operation of a radiopharma-

ceutical processing plant are not barred by the doctrine of

federa) preemption.

(ii)

In support of this motion, the Society and ANS state as

follows:

1. The Society is a not-for-profit organization of more

than 10,000 members with career interests in the diagnos-

tic and therapeutic uses of radiopharmaceuticals. The

principal activity of the Society is the development and ex-

change of scientific information in the field of nuclear

medicine among its members and the public for the benefit

of the public in general. Many of the Society’s members,

or the institutions for which they work, are licensed by the

Nuclear Regulatory Commission.

The ANS is a not-for-profit scientific and educational

organization with 14,000 individual members, including

nuclear scientists and engineers, and 250 organizational

members, including electric utilities and other companies

and institutions licensed by the Nuclear Regulatory Com-

mission. The principal objective of the ANS is to advance

engineering and science related to atomic energy. This ob-

jective is accomplished by encouraging research, disse-

minating information, sponsoring meetings devoted to

scientific and technical papers, setting voluntary stan-

dards, and cooperating with government agencies, educa-

tional institutions, and other organizations having similar

purposes.

2. This case is of major interest to the Socieiv, the

ANS, and their members. The decision of the Missouri

court, if allowed to stand, could subject members of the

Society and of the ANS, or the institutions for which their

members work, to potential state tort liability for federally

authorized activities carried on in the ordinary course of

business and in compliance with federal standards. The ef-

fect of such liability could be that the Society’s members

and ANS’s members, or the institutions for which they

. (iii)

work, will be forced to curtail or abandon their work in

the field of atomic energy.

3. The motion of the Society and ANS should be grant-

ed because the Society and ANS will address the effect of

the Missouri court’s decision on the research, development

and uses of atomic energy, such as nuclear medicine and

electricity generation, in our social environment, and on

the persons and educational! and other institutions involv-

ed in the development and use of atomic energy, a perspec-

tive and interest not otherwise represented in this case.

Wherefore, the Society and ANS request that leave to

file the propc<ed brief be granted.

Respectfully submitted,

L. Manning Muntzing*

Robert J. Ross

James R. Shoemaker

Doub & Muntzing, Chartered

1875 Eye Street, N.W.

Suite 775

Washington, D.C. 20006

Of Counsel: (202) 467-6460

James R. Heelan Attorneys for Amici Curiae

Resident Counsel SOCIETY OF NUCLEAR

MEDICINE, INC.

AMERICAN NUCLEAR SOCIETY ’

555 N. Kensington Avenue AMERICAN NUCLEAR

La Grange Park, IL 60525 SOCIETY

(312) 352-6611 *Counsel of Record

May 19, 1986

(v)

TABLE OF CONTENTS

Page

MOTION FOR LEAVE TO FILE AS AMICI CURIAE .......... i

pe Bee 2 ee et Perr rrr Terre Vv

INTEREST Of THE SOCIETY OF NUCLEAR

MEDICINE AND THE AMERICAN NUCLEAR

TE 8s Ran 2RRAK SU ee EEASE ERA SES ETN E ba CRA gn SRRSEEA 2

REASONS FOR GRANTING THE PETITION ................ 4

(vi)

TABLE OF AUTHORITIES

Cases: Page

Duke Power Co. v. Carolina Environmental Study

Group, Tnc., 486 U.S. FOCIGTE) .. ww cee cccesnscccccccncecces 4

Johnston v. United States,

997 F. Supp. 374 CD. Mam. 1906) ow ccc cere cess ccsennces 13

Northern States Power Co. v. Minnesota,

447 F.2d 1143 (8th Cir. 1971), aff,

GGG UB. PBS CIGTED on ven ck eta Wcdscercccesecnssaeenvsdes 6

Pacific Gas & Elec. Co. v. State Energy Resources

Conservation & Dev. Comm'n,

461 U.S. 190 (1983) 2... cee ee eee 4, passim

San Diego Building Trade Council v. Garmon,

SOD UD. FIG CIGID nnn c cs cccnvecccenescvcusssunssenencs 13

Silkwood v. Kerr-McGee Corp.,

464 U.S. 238 (1984) ... 2... eee phe asnnesenastaes 4, 6

Statutes:

Atomic Energy Act of 1954,

GB UBC. SABER CE ONR. occ ccc ccc sastusnsccccnasrnedancess 4

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(vii)

Page

Energy and Water Development Appropriations,

By ee 9

Price-Anderson Act, 42 U.S.C. §2210 ef seq. ... 2.6... ee ce ees 5

Legislative Materials:

Department of Energy Fiscal Year 1987 Budget:

Hearings on H.R. 2959 Before the Subcomm. -on

Energy and Water Dev. of the House Appropriations

Comm., 99th Cong., 2d Sess. (1986) (Statement of

Stanley J. Goldsmith, M.D. on behalf of the Society

of Nuclear Medicine and the American College of

ae cc cau adeew ine rie Ceeweb kenekkdeads 8

H.R. Rep. No. 99-307, 99th Cong., Ist Sess. (1985) .............. 9

S. Rep. No. 879, 86th Cong., Ist Sess. (1959) ................5.. 7

S. Rep. No. 296, 85th Cong., Ist Sess., reprinted in

1987 U.S. Code Cong. & Ad. News 1803 ...................5. 6

Administrative Regulations:

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40 Fed. Reg. 58,847 (December 19, 1975) ....................2.. i4

35 Fed. Reg. 18,385 (December 3, 1970) .....................88. 12

25 Fed. Reg. 8595 (September 7, 1960) ..................... 13,14

(viii)

Page

Miscellaneous:

G. Tokuhata and E. Digon, Cancer Mortality and

Morbidity (Incidence) Around TMI (1985) ...... 2.66. 0655555 14

G. Mazuzan and J. Walker, Controlling The Atom:

The Beginnings of Nuclear Regulation 1946-1962

(Berkeley: University of California Press 1984) .............. 6,7

Report of the President’s Commission on the Accident

eb TE nb Nin 5 5a 6649 0.0400 500045 ascenarinenen 14

IN THE

Supreme Court of the Wnited States

OCTOBER TERM, 1985

No. 85-1710

MALLINCKRODT, INC.,

Petitioner,

Vv.

SAMUEL F. BENNETT, ef ai.,

Respondents.

JOINT SKiEF OF SOCIETY OF NUCLEAR

MEDICINE, INC. AND AMERICAN NUCLEAR

SOCIETY AS AMICI CURIAE IN

SUPPORT OF PETITIONER

The Society of Nuclear Medicine, Inc. (“Society”) and

the American Nuclear Society (“ANS”) have filed a mo-

tion with this Court pursuant to Supreme Court Rule 36.1.

for leave to file a joint brief as amici curiae in support of

the Petition for Certiorari of Mallinckrodt, Inc., in the

above captioned case. The Society and ANS filed their

motion because the respondents refused to provide their

written consent to the Society and ANS to participate in

this case as amici curiae in support of the petitioner. As re-

quired by Rule 36.1., the Society and ANS are submitting

this bne: together with their motion.

INTEREST OF THE SOCIETY OF NUCLEAR

MEDICINE AND THE AMERICAN

NUCLEAR SOCIETY

The Society is a not-for-profit organization comprised

of approximately 10,000 physicians, physicists, chemists,

radiopharmacists, nuclear medicine technologists, and

other professionals engaged in the medical uses of radioac-

tive materials. The principal activity of the Society is the

development and exchange of scientific information in the

field of nuclear medicine among its members and the put-

lic.

The ANS is a not-for-profit scientific and educational

organization with over 14,000 individual members, mainly

nuclear scientists and engineers, and 250 organizational

members, including ciectric utilities and nuclear labora-

tories. The ANS works to advance engineering and science

related to atomic energy in the United States and abroad.

To this end, the ANS engages in the dissemination of

scientific and engineering information through publica-

tions, meetings, workshops, and conferences. In addition,

the ANS encourages research in atomic energy, sets volun-

tary industry standards, and cooperates with government

agencies, educational institutions, and other organizations

involved in atomic energy activities.

The Society and ANS are interested in the present litiga-

tion because of the great impact that this case wi.l have on

the many members of the Society and of ANS who are li-

censed by the Nuclear Regulatory Commission (NRC), or

who work for institutions licensed by the NRC, to carry on

activities in the field of atomic energy, such as nuclear

medicine, nuclear power generation, nuclear fuel fabrica-

tion, radioisotope production, radiopharmaceuticals ma-

nufacture, and research and development of new uses of

atomic energy. If the decision of the Missouri Court of

Appeals is allowed to stand, the decision will establish a

precedent that could subject members of the Society and

of ANS, or the institutions for which their members work,

to potential state tort liability for federally authorized ac-

tivities carried on in the ordinary course of business in

compliance with applicable federal standards for nuclear

safety and radioactive emissions. Such potential liability

could cause members of the Society and of ANS, or the in-

stitutions for which they work, to curtail or abandon their

activities in the field of atomic energy. The Society and

ANS believe that the federal government’s pervasive

regulation of radiological safety matters precludes state

law tort actions for alleged radiological injuries against

NRC licensees that operate in compliance with NRC safety

standards.

The interests of the Society and of ANS in this case are

congruent with the nation’s interest. Both Congress and

the Executive Branch have determined that the develop-

ment and use of atomic energy for civilian applications are

important to the nation, in that progress in the uses of

atomic energy raises the quality of life, benefits the general

welfare of the people of the United States, and strengthens

national security. The Missouri court’s opinion is inimical

to national policy because it creates an obstacle to the con-

tinued development and use of atomic energy.

For these reasons, the Society and the ANS support the

petitioner’s request for this Court to review the decision of

the Missouri Court of Appeals.

REASONS FOR GRANTING THE PETITION

A. Subjecting NRC Licensees to Tort Liability for

Activities Carried on in Compliance with NRC

Safety Standards Frustrates the Purpose and

Objectives of the Atomic Energy Act and Af-

fects Broad Public Policy Concerns.

The subjection of NRC licensees to state law tort actions

for monetary damages when such licensees are operating

in compliance with federal standards for radioactive emis-

sions would frustrate one of the major purposes of the

Atomic Energy Act of 1954, as amended, 42 U.S.C. §2011

et seq. (1982), and would affect broad public policy con-

cerns. Congress enacted the Atomic Energy Act of 1954 to

encourage private industry to participate in the develop-

ment and utilization of the peaceful applications of atomic

energy.' &.g., Pacific Gas & Elec. Co. v. State Energy

Resources Conservation & Dev. Comm’n, 461 U.S. 190,

221 (1983); 42 U.S.C. §2013(d). See also Silkwood v. Kerr-

McGee Corp., 464 U.S. 238, 281 (1984) (Powell, J.,

dissenting); Duke Power Co. v. Carolina Environmental

Study Group, Inc., 438 U.S. 59, 63 (1978). In the Atomic

Energy Act Congress declared that atomic energy is

capable of application for peacefui purposes, and that

(a) the development, use, and control of atomic

energy shall be directed so as to make the maxi-

mum contribution to the general welfare, .. .

and

)

'Peaceful uses of atomic energy include, among other uses, the use

of radioactive materials for medical purposes, the use of enriched

uranium or plutonium for electricity generation, and the use of radia-

tion as a food preservative. The term “atomic energy” is used in this

brief in a broad sense to include the various peaceful uses of radioac-

tive materials.

(b) the development, use, and control of atomic

energy shall be directed so as to promote world

peace, improve the general welfare, increase the

standard of living, and strengthen free competi-

tion in private enterprise. 42 U.S.C. §2011.

These declarations demonstrate Congress’ intent in the

Atomic Energy Act to encourage the private development

and use of the peaceful applications of atomic energy for

the benefit of the people of the United States.

Congress also indicated in the Atomic Energy Act its

desire for the federal government to promote the peaceful

applications of atomic energy by assisting private industry

in developing the atom’s uses. The Act states that United

States funds “may be provided for the development and

use of atomic energy.” Jd. §2012(g). In addition, the Act

states that the federal government shall provide “a pro-

gram of conducting, assisting, and fostering research and

development in order to encourage maximum scientific

and industrial progress” in atomic energy applications. Jd.

§2013(a). In order to “encourage scientific and industrial

progress,” Congress also provided for the transfer from

the federal government to private industry of “unclassified

scientific and technical information and for the. . . dis-

semination, and declassification of Restricted Data”, as

defined in the Act. Jd. §2013(b). Finally, Congress intend-

ed to promote the development of atomic energy on an in-

ternational scale, by “mak[ing] available to cooperating

nations the benefits of peaceful applications of atomic

energy. . .”. Id. §2013(e).

In 1957, Congress continued its efforts to promote

the civilian development of atomic energy by passing the

Price-Anderson Act, 42 U.S.C. §2210 et seq. (1982), in

response to private industry’s concern about potential

bankrupting liability associated with the possibility of a

nuclear accident. See Silkwood v. Kerr-McGee Corp., 464

U.S. at 279; S. Rep. No. 296, reprinted in 1957 U.S. CopDE

Conc. & Ap. News 1803, 1816. The Price-Anderson Act

provides a comprehensive scheme of insurance and indem-

nity protection for persons licensed to possess nuclear

materials and to operate nuclear facilities. In addition to

providing protection, and thus encouragement, to private

industry, the Price-Anderson Act was also intended to

protect the public by assuring compensation for persons

who suffer personal injury or property damage as a result

of a nuclear accident. E.g., Silkwood vy. Kerr-McGee

Corp., 464 U.S. at 279.

In order to foster an-environment conducive to private

development of atomic energy, Congress preempted state

regulation of atomic safety matters when it enacted the

Atomic Enery Act. See, e.g., Pacific Gas & Elec. Co., 461

U.S. at 206-212; Northern States Power Co. v. Minnesota,

447 F.2d 1143, 1147-1154 (&th Cir. 1971), aff'd, 405 U.S.

1035 (1972). Congress was concerned that the states lacked

the experience and technical knowledge to regulate atomic

energy matters intelligently and effectively. G. MAZUZAN &

J. WALKER, CONTROLLING THE ATOM: THE BEGINNINGS OF

NUCLEAR REGULATION 1946-1962 295 (Berkeley: Universi-

ty of California Press 1984) [hereinafter cited as Con-

TROLLING THE ATOM]. Therefore, Congress vested the

Atomic Energy Commission (AEC), now the Nuclear

Regulatory Commission (NRC), with exclusive authority

to regulate atomic safety matters. E.g., Pacific Gas &

Electric Co., 461 U.S. at 212.

When some states began demanding a role in atomic

energy regulation, the AEC and the Joint Committee on

Atomic Energy in Congress became concerned that state

regulatory efforts could conflict with federal regulation

fas.

and create confusion and other obstacles that would im-

pair the development of atomic energy. See CONTROLLING

THE ATOM, supra, at 300-302. The Joint Committee thus

began considering legislation to define more cleariy the

respective roles of the federai government and the states in

regulating atomic energy. /d. The result was a 1959

amendment to the Atomic Energy Act, which authorized

the AEC to transfer by agreement some regulatory

authority over nuclear materials to any state that adopted

a suitable regulatory program. 42 U.S.C. §2021. See aiso

Pacific Gas & Electric Co., 461 U.S. at 205. Section 274(b)

of the Atomic Energy Act, 42 U.S.C. §2021(b), authorizes

states to assume certain regulatory control over radiation

hazards associated with nuclear materials, but requires

State radiation proiection programs to be “coordinated

and compatible” with NRC regulations. /d. §202i(g); S.

Rep. No. 870, 86th Cong. Ist Sess. 11 (1959). Thus, Con-

gress intended that the limited regulatory authority assum-

ed by states pursuant to a Section 274 agreement with the

NRC should not conflict with federal regulation or impair

the development of atomic energy. See Pacific Gas & Elec-

tric Co., 461 U.S. at 208-209; 42 U.S.C. §2021(g); S. Rep.

No. 870 at 11.

The foregoing history of atomic energy legislation

demonstrates Congress’ strong intention in the Atomic

Energy Act ‘o encourage and promote development of the

peaceful uses of atomic energy. If NRC licensees operating

in full compliance with NRC radioactive emissions stan-

dards may be subjected to state tort liability for injuries

and property damage allegedly caused by authorized emis-

sions, the important purpose of the Atomic Energy Act of

promoting the development of peaceful applications of

atomic energy will be frustrated. Institutions and private

companies that develop atomic energy applications and

put them to use for the public good will be discouraged

from continuing their operations. Nuclear research institu-

tions, producers of nuclear medicine products, hospitals

that administer nuclear medicine, electric utilities that use

nuclear power to serve their customers, to name only a

few, may choose to curtail or abandon the development

and use of atomic energy applications. Such an outcome

would be counter to the Atomic Energy Act’s express pur-

pose of encouraging and promoting peaceful applications

of atomic energy for the benefit of the United States by

improving the general welfare, increasing the standard of

living, and strengthening free competition in private enter-

prise.

Broad public policy concerns are at stake in this case.

The use of atomic energy in the diagnosis and treatment of

disease, the generation of electricity, and the improvement

of agriculture are some of the great accomplishments of

the atomic age. The Missouri court’s ruling is inimical

to the further development and use of atomic energy for

these and other purposes. If the court’s decision is allowed

to stand, the potential multiplicity of lawsuits faced by

persons and institutions in the field of atomic energy could

impede and perhaps prevent further progress in the devel-

opment and use of atomic energy for peaceful purposes.

Congress and the Executive Branch have determined

that the development and use of atomic energy are in the

national interest. Congress continues to fund the Depart.

ment of Energy’s (DOE) atomic energy programs. For fis-

cai year 1986, Congress appropriated $23.3 million for the

DOE Nuclear Medicine Applications Program. De-

partment of Energy Fiscal Year 1987 Budget: Hearings on

H.R. 2959 Before the Subcomm. on Energy and Water

Dev. of the House Appropriations Comm., 99th Cong.,

2d Sess. 1 (1986) (Statement of Stanley J. Goldsmith,

9

M.D. on behalf of the Society of Nuclear Medicine and

the American College of Nuclear Physicians); see Energy

and Water Development Appropriations, Pub. L. No.

99-141, 99 Stat. 572-576 (1985). In addition, Congress ap-

propriated a total of $377,625,000 for DOE’s civilian

nuclear energy research and development programs in

1986. See H.R. Rep. No. 99-307, 9°th Cong., Ist Sess.

39-55 (1985); Energy and Water Development Appropria-

tions, Pub. L. No. 99-141, 99 Stat. 572-576 (1985). These

programs include the Light Water Reactor Program, Ad-

vanced Reactor Research and Development, and the Wa-

ter Cooled Breeder Reactor Program. Under these and

other atomic energy programs, DOE works with scientific

institutions and private industry to develop new and im-

proved uses of atomic energy for nuclear medicine, elec-

tricity generation, and other purposes. This support in

Congress and the Administration for atomic energy devel-

opment, even during a period of severe federal budgetary

constraints and cost-cutting measures, demonstrates that

Congress and the Administration believe that progress in

atomic energy applications is important to the nation.

Nuclear medicine has many significant applications, in-

cluding diagnosis and evaluation of heart disease, cancer,

infant disorders, Alzheimer’s disease and mental disor-

ders. Radiopharmaceutical producers such as the peti-

tioner, Mallinckrodt, Inc., make possible the practice of

nuclear medicine. There are only a few such producers in

the United States.? If these producers are subjected to

2There are only a handful of radiopharmaceutical manufacturers in

the United States. The major companies are:

AMERSHAM CORPORATION DU PONT COMPANY

2636 S. Clearbrook Dri-e¢ Diagnostic Imaging Division

Arlington Heights, IL 60005 331 Treble Cove Road

No. Billerica, MA 01862

unlimited tort liability for radiation injuries allegedly

caused by activities carried on in the normal course of

business in compliance with stringent federal safety stan-

dards for radioactive emissions, the producers may be

forced to abandon their operations. The liability risk and

the cost of liability insurance may prove too great to per-

mit these companies to continue producing radiopharma-

ceutical products, which are the tools of nuclear medicine.

Without the products that these companies provide, hospi-

tals and other institutions now practicing nuclear medicine

will be unable to continue to offer their many diagnostic

and therapeutic nuclear niedical services. Research and

development in the field of nuclear medicine may also be

harmed by the lower court’s ruling. Research institutions

may be forced by the specter of unlimited tort liability to

reduce or discontinue their work to identify and develop

new and better medical uses for radioactive materials. This

result would be devastating to the health and welfare of

the people of the United States who have come to depend

on the health care benefits that nuclear medicine provides.

The negative impact of the Missouri court’s decision is

not limited to the field of nuclear medicine. Every industry

that uses radioactive materials for civilian applications is

threatened by the court’s decision. Electric utilities with

nuclear power plants generating electricity for the nation,

MALLINCKRODT, INC. MEDI-”?HYSICS, INC.

Diagnostic Products Group 4050 Lakeside Drive

675 McDonnell Blvd. Richmond, CA 94806

P.O. Box 5840

St. Louis, MO 63134

SQUIBB DIAGNOSTICS

P.O. Box 191

New Brunswick, NJ 08903

SYNCOR INTERNATIONAL - CIS USA {manufacturers for SYNCOR)

CORPORATION 1983 Marcus Avenue

12847 Arroyo Street Lake Success, NY 11042

Sylmar, CA 91342

il

hazardous waste managers treating and disposing of the

nation’s nuclear debris, institutions developing nuclear

agricultural techniques such as food irradiation, and re-

search facilities exploring better ways to use atomic energy

in these and other endeavors wil! all feel the effects of the

lower court’s ruling. Without protection from unlimited

tort liability arising out of activities carried on in com-

pliance with federal safety standards for radioactive emis-

sions, many of these industries may be forced to reduce or

abandon their services to the public. Such a result would

be counter to the national interest and detrimental to the

welfare of the people of the United States.

B. Subjecting NRC Licensees to State Tort Liabil-

ity When Such Licensees are Operating in Com-

pliance With Federal Emissions Standards Con-

flicts With NRC Regulations and Imposes an

Unnecessary Burden on the Atomic Energy In-

dustry

Many members of the Society and the ANS are licensed

by the NRC to possess nuclear materials or to operate nu-

clear facilities, and many other members are employed by

licensed institutions or companies. As a condition of their

licenses, these licensees are subject to a stringent federal

regulatory regime for nuclear safety.* Imposing state tort

liability on NRC licensees that operate in compliance with

ibis detailed and pervasive federal regulatory scheme con-

3The Atomic Energy Act of 1954 and implementing regulations con-

tain detailed licensing requirements for persons engaged in the use of

nuclear materials and the operation of nuclear facilities. See 42 U.S.C.

§§2073, 2092, 2093, 2111, 2133, 2134 (1982); 10 C.F.R. Parts 30, 40,

50, 70 (1985).

4F.2., 10 C.F.R. §20.2 (1985) (NRC radiation protection standards

apply to all licensees).

12

stitutes unnecessary and burdensome state regulation of nu-

clear safety matters in conflict with NRC’s nuclear safety

standards.

The NRC requires its licensees to comply with extraor-

dinary detailed regulations governing every aspect of nu-

clear health and safety. NRC’s regulations governing ra-

diation exposure limits are of particular relevance to this

case. These regulations, codified at 10 C.F.R. Part 20

(1985), protect nuclear workers and the general public from

the effects of radiation sy establishing limits on the dose of

radiation and the amount of radionuclides that may be re-

leased on-site at a nuclear facility and off-site into the en-

vironment. Specific limitations on hourly and weekly radia-

tion levels surrounding licensed facilities are set forth in 10

C.F.R. §20.105(b) (1985). Maximum permissible concen-

trations of radionuclides in the air and water outside of a

licensed facility are set forth in 10 C.F.R. Appendix B,

Table II (1985). Licensees ynust comply with these stringent

safety standards in conducting licensed activities. 10 C.F.R.

§20.2 (1985).

In addition to these specific radiation limits, Part 20 ir-

poses a second level of protection for workers and the gen-

eral public in 10 C.F.R. §20.1(c) (1985). This section re-

quires licensees to make every reasonable effort to main-

tain radiation exposures and releases of radioactive ef-

fluents “as low as reasonably achievable” (ALARA). The

ALARA concept is based on the fact that licensees gen-

erally keep exposures to radiation and releases of radio-

active effluents well below the Part 20 limits. See 35 Fed.

SNRC’s regulations governing the possession, use, processing, stor-

age, transfer, packaging, and disposal of nuclear materials constitute

an extensive regulatory scheme for nuclear health and safety. See 10

C.F.R. Parts 0-170 (1985).

13

Reg. 18,385 (December 3, 1970) (AEC comments on

ALARA regulation). By requiring licensees to maintain

exposure limits and effluent limits as low as reasonably

achievable, the ALARA regulation helps to ensure that ac-

tual exposure and effluent levels are below the Part 20

limits.

NRC’s radiation safety standards represent a conser-

vative approach to radiation protection. See, e.g., 25 Fed.

Reg. 8595 (September 7, 1960). See also Johnston vy.

United States, 597 F. Supp. 374, 390-392, 423 (D. Kan.

1984). Scientific and medical evidence indicates that the

lowest radiation exposure levels known to cause physical

injuries are many times higher than the Part 20 limits. See

Johnston v. United States, 597 F. Supp. at 390-392, 423.

Thus, NRC’s radiation safety regulations provide more

than adequate protection for workers and the general pub-

lic against health effects from radiation.

Subjecting NRC licensees who are operating in compli-

ance with NRC radioactive effluent regulations to state

tort liability constitutes the imposition of more stringent

radiation protection standards than the standards required

by NRC regulations. This Court has stated that “regula-

tion can be as effectively asserted through an award of

damages as through some form of preventive relief.” San

Diego Building Trade Council v. Garmon, 359 U.S. 236,

247 (1959). State law damages awards would permit juries

to impose on licensees a “zero release” regulatory stan-

dard, since licensees could avoid the risk of liability only

by eliminating all radioactive emissions from their facili-

ties.

The NRC has determined that a zero release standard is

unnecessary to protect public health and safety. See 10

C.F.R. Part 20. See also Johnston v. United States, §97 F.

i4

Supp. at 390-392, 423. NRC’s regulations contain a substan-

tial “margin of safety” and are based on the recommenda-

tions of leading institutions that are authoritative in the

field of radiation protection. NRC’s safety regulations

have an excellent success record. Even the Three Mile Is-

land accident, the most serious nuclear accident in U.S.

history, has not had a significant effect on the physical

heaith of individuals living and working near the reactor.’

More stringent state standards would not only conflict

with NRC’s fully adequate standards, but would be com-

pletely unnecessary and burdensome to industry. Arbi-

trary state radiation standards imposed by juries would in-

ject uncertainty and confusion into the nuclear regulatory

system, since NRC licensees would be subjected to conflic-

ting regulatory systems at the federal and state levels. Such

a scenario would have a profouad negative impact on the

atomic energy industry, and on research and educational

activities related to the industry.

*See 40 Fed. Reg. 58,847 (Decembe: 19, 1975) (10 C.F.R. Part 20

ALARA regulations are\based on recommendations of Internationa!

Commission on Radiation Protection); 25 Fed. Reg. 8595 (September

7, 1960) (i0 C.F.R. Part 20 revisions containing “considerable margin

of safety” are based on recommendations of National Council on

Radiation Protection).

’See G. Tokuhata and E. Digon, Cancer Mortality & Mobidity (In-

cidence) Around TMI 24 (1985); Report of the President’s Commis-

sion on the Accident at Three Mile Island 12 (1979).

15

CONCLUSION

The petition for a writ of certiorari to the Missouri Court

of Appeals should be granted.

Of Counsel:

James R. Heelan

Resident Counsel

AMERICAN NUCLEAR SOCIETY

555 N. Kensington Avenue

La Grange Park, IL 60525

(312) 352-6611

May 17, 1986

Respectfully submitted,

L. Manning Muntzing*

Robert J. Ross

James R. Shoemaker

Doub & Muntzing, Chartered

1875 Eye Street, N.W.

Suite 775

Washington, D.C. 20006

(202) 467-6460

Attorneys for Amici Curiae

SOCIETY OF NUCLEAR

MEDICINE, INC.

AMERICAN NUCLEAR

SOCIETY

*Counsel of Record