# Amicus Curiae Brief — Mallinckrodt, Inc. v. Bennett

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URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385018_1753%3A6

## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 1986
- **Citation:** 476 U.S. 1176

## Text

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~ Petitioner,
v.

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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ET NE bk 6.6 8 a6 4 snc One e eOR SHEE AR SEN NEC R C KNEES 11
BNO 6. 60a 0 ek 04s he KREeEAe AR Eke eeKweneNee 11
ND v6 5 ian 604554045500 64054 SSE eR eh sae 11
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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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I ns cae le Veh ackucbcakeb lev eaeneecotan 12,13
Ne oe, ch cain baA AAR AkARE ESS ERMA AD KOR 11
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I ee ee er ek nw eae ARK Oks ates 12
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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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385018_1753%3A6. Public record. Not legal advice.