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INTRODUCTION
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to
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structured
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nature,
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experiments
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therefore,
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scientific
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of
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a
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amount
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patent
process.
These
recommendations
but a r e o f f e r e d
as
are not
suggestions
unified
policy
for
intended
to preclude
regulation
federal
agencies.
They
regulation
of
committee
other
the n e w
RAC
to
on which
regulating
scientific
than
are,
rDNA
of
of
to
to be
in f i n a l
begin
however,
in
RAC, and
scientific
They
are
a
not
rDNA technology
intended
rDNA
form,
formulating
experiments.
p r o d u c t s of
processes
the-new
regulation
intended
to
research
to limit
by
preclude
by
any
jurisdiction
processes not
products.
of
1.
See
Nathans,
Berg,
Roblin,
Baltimore,
Watson,
o£_Reggmbinant_DNA
[hereinafter
2.
Envtl.
F.
3.
See,
Guidelines,
whether
as
as
Berg
Fiel ding,
13,
16
Weissman
Molecules,
cited
See
Boyer,
dangers
of
4.
James
Watson
the
model
-for
Pgtential_Biohazards
Science
1114,
171
5.
Nature
DNA
Zinder,
(1973)
and_.the .Peri 1 ,
in
Proposed
59,382
(1981)
are qualitatively
Francis
DNA
Research:
59,368,
research
and
737
1114
1985).
Crick
1953.
proposed
Watson
S<
S t r u c t u r e _ o f „ N u c l e i c „ A c i d s ^ _ A _ S t r u c t u r e ,.fg.r
Acid,
Hogness,
letter!.
Reg.
rDNA
Davis,
BiotechnologyThe.,Promise
(Aug.
Fed.
& Zinder,
:L8i
e-.g._, R e c o m b i n a n t
46
Cohen,
Revised
(questioning
unique).
the
double
Crick,
helix
Molecular
Deoxyribose__.Nucleic
(1953).
From
Genetics.
to Genetic ..Engineering,
in
From
Sen.et.ic._Ex p e r i ] m e n t a t i g n _ t g _ B i g t e c h D o l . q g . y ~
13,
14-17
6.
(1982).
The
term
"rDNA
investigating
the
laboratories
are
technology
manufacture
bright
rDNA
line
Technology,
term,
fuses
51
however,
of
S.
o-f o r g a n i s m s
engaged
exists
technology.
technology
part
to
nature
technology"
in
One
Cal .
science
scientist
both
terms.
L. Rev.
experimentation
scientific
research'-
by using
science
commercial
between
is misleading.
while
products
and
even
See
in r D N A
technology
the
use
rDNA
is technology.
No
in t h e
argued
Cavalieri,
1153
in
o-f
technology
has
1153,
rDNA
Scientists
(1978).
technology
case
that
of
rDNA
Science... a s
Under
is an
either
integral
\
Biotechnology,
de-fined a s
"any
organisms)
to make
animals
Human
for
technique
or
The
in B i o t e c h n o l o g y ,
to the
NIH
regulation
experiments
of
See Weinberg,
(Oct.
and
See
938, 938
stating
"[ilf
16-17
(describing
"hairy
nine-foot
NIH
9.
or
Health
and
of
of
Leadership
the
of H e a l t h
This Article
Advisory
1
U985)
is limited
to
technology.
Am.
48,
t h e „ D . a n g e r s _ o f ..Genet ic_.Meddl.ing,
(referring
Dr.
to
"second
Frankenstein
monsters");
reports
degree
must, g o o n
see_al_so F i e l d i n g ,
of
creature").
"strange
But„see
193
Science
186,
supra
his
note 2,
creature"
?< B e r g ,
187
biology";
producing
orange-eyed
Singer
192
at
and
Recombinant
(1976)
(disputing
arguments).
See
Singer,
Szybalski,
Richmond,
Pritchard,
Peacock
?•<
Wha£_Lessons_.Does„the_R
Coomb e s ,
Table
Discussion,
£>:.eeCl©entati.gn
223,
Szybalski]
(statement
1976
which
(in
referred
Zinder,
in r D N A
On
Guidelines,
Chargaff's
been
Institutes
RoleD.
plants
I h e _ M o l _ e c u l e s _ _ o f ...Life, 2 5 2 S c i .
(1976)
biological
Round
NIH
Chargaff,
little
DNAs
National
of
the Nation's
the 51st Meeting
been
(or p a r t s
improve
Department
has
1985).
8.
Science
U.S.
of
organisms
or to
in F o s t e r i n g
Proceedings
as
technology,
living
products,
Role
Director,
rDNA
uses
use."
cited
48
that
modify
[hereinafter
7.
includes
beneficial
Services,
Committee
which
supra
note
236
of
year
to by
Recombinant
(1979)
at
..and
cited
The two year
NIH Guidelines
commentator
16.
DNA
[hereinafter
J. Coombes).
the first
one
5,
in
Genetic
a s S i n g e r S<
period
were
as the Recombinant
after
issued)
DNA
has
War.
a.
10-
See
Sweezy
(Frankfurter,
disputation
necessary
J.,
on
DNA„Research,
in
201
scientific
of
for
observation
the
inquiry
is implicit
of
. . .
clearly
An
am
speech
(1977)
advancement
prepared
and
to
simply
"the
. . . ."
press");
may
be made that
Delgado
& Miller,
375
constitutional
similarity
665,
to
(discussing
cf.
to
(197S).
the
analogy
of
See
.also
240
and
the first
this
(1983)
of
guarantee
L.
Rev.
information
is
amendment").
experimentation
in t h e s c i e n t i f i c
is
process
a n d _ G g v e r n m e n t s. ..Toward
Branzburg
53 Wash.
should
analysis
b e c a u s e of
v. Hayes,
and
L.
receive
408
D e l g a d o & M i l l e r , supra,, at
information-gathering
J . Ri.fk.in, A l g e n y
freedom
T h e ..Sci entist.'.s
Scientific_Inguiry,
under
see
step
Politics
51 S . Cal .
Experimentation
news-gathering.
(1972);
of
G o d , G a l i. l e o 4
for_
protection
681-82
are
and
that
Robertson,
scientific
information-gathering
349,
for
scientific
Amendment
knowledge
the protection
Constitutional... P r o t e c t i o n
Rev.
(1957)
freedom
of
argue
in t h e F i r s t
("Cslcientific
within
argument
263
and e x p e r i m e n t
Right...to_Research?. A_.Constitutionaj... A n a l y s i s ,
1216
and
Reconibinant_..DN A ; S c i e n c e , E t h i c s ,
("I
1203,
234,
. a l s o G r e e n , A L e g a l . Perspective... on... R e c o m b i n a n t
(197S)
freedom
354 U . S .
("-freedom t o r e a s o n
b a s i s of
conditions
see
Hampshire,
concurring)
the
knowledge");
193,
v. New
its
U.S.
375
news-gathering);
(" C k l n o w l e d g e h a s b e e n
reduced
information").
11.
580-82
12.
S e e .general ly L .
Tribe,
American„._Cgnstitut.ioQ.#.l
Law
(1978).
A
thought
imagines'specific
experiment
natural
is
or u n n a t u r a l
®01f>2
one
in
which
conditions
and
a
scientist
events
in
3
order
to
increase
his
scientific
f o r ._ T h o u g h t . . . E x p e r i m e n t s ,
A1. e x a n d r e _ R o y r e 3 0 7
(ed.
I. H a c k i n g
13.
NAACP
dissenting)
speech
rDNA
Standards
v. Button,
L.
conduct,
Professor
Spece,
14.
A
Spece
(statement
15.
60
1286
aimed
of
considers
might
apply
aimed
with
J.,
speech
the
as
pure
to the regulation
of
of
Constitutional
Assessment... of _ t h e
Research,
(1978).
at physical
(Harlan,
that
Analysis
n.12
to regulations
51
Professor
safety
as
S.
Spece
regulating
at p r e v e n t i n g
knowledge
as
Id...
Hearings.Before
of
862
the Subcomm.
on
Policy
on
Science
1978)
of
and
[hereinafter
Research
and
Techngl_ogy,
cited
of
Law
Report,
cited
Thomas Emerson,
supra
note
Yale School
Center).
of
Molecule
Yale Law
15, at 6 0
the
Sess.,
Reseach
as Science
of L a w ) .
95th
PNA_Hearingsl
Technology
DNA Recombinant
[hereinafter
Emerson,
and
as
T e c h n o l o g y , 95th C o n g . , 2d
Professor
Policy
Thomas
gn ..Science
Science,
Implications
(statement
an_Sciencei_Research_and
Jerome Barron, National
Science
Print
Professor
(1977)
Professor
Subcomm.
(Comm.
16.
associated
Purposive
1281,
speech.
Comm.
Report3
(1963)
Reyigw_and_a .Practical
regulations
1st S e s s .
Science
415, 455
conduct
Iechngiggy..of _.the_Hguse_Comm^
House
6
S c i e n c . e _ P o l i c y _ I m p l i c a t i o n s _ o f _ D N A _ R e c o m b i n a n t _ Mgl.ec.ule
Research,
Cong.,
in S c ^ e n t i fi c. R e v o l u t i o n s
i.ty._of . . . R e g u l a t i n g . . R e c o m b i n a n t . . D N A
compared
regulating
U.S.
distinction
Rev.
categorizes
371
to
Judicial
Constitutional
Cal.
(1964), reprinted
plus
of
Function
1983).
plus).
research.
See Kuhn, A
in 2 L'.Ayc-nture.. de...l a . S c i e n c e , ...Melanges
(referring
speech/speech
knowledge.
Policy
School).
(statement
Regulation
of
enacted
conduct
pursuant
so
constitutional
of
aspects
O'Brien,
366
free
391
U.S.
long
speech
U.S.
36,
to
a
as
its
are
367,
50-51
legitimate
governmental
effects
incidental.
381-82
Recombinant„._DNA.. R e s e a r c h :
See
United
Konigsberg
g e n e r a l l.y
..Hearings
Before.
[hereinafter
cited
as
(statement
of
Washington
University
regulation
of
attain
David
(1978)
policy
(statement
SB i s n o t
protected
Cong.,
Recombinant
Newburger,
School
nuclear
public
95th
goals).
of
Rep.
by
first
on
1st S e s s .
and
355-56
But...see
Ottinger)
types
124
Hearings]
of
but
Law,
federal
research
C-ong.
(arguing
amendment,
of
on
(1977)
(describing
other
..of
.Commerce,
Professor
Law)
Bar,
Subcgmm.
_ DNA...Research..
of
v.
Regulation.
the
Assistant
research
States
v.. S t a t e
S c i e n c e ^ . . J e c h n o l o g y , ..and.. S p a c e .of ..the Senate... C o m m . .
Science^„anc[_IransBortation,
is
communicative
the
See
(1963);
(196:1).
on
interest
Rec.
that
to
3395
research
per
advocacy
of
only
research) .
17.
G£s.
(1968)
United
(state
States
hat.
legitimate
noncommunicati ve
impact
of
10, a t
reason
why
204
regulated
of i n j u r y
(no
to
to
same
the
environment").
that
its
i 1963J .
health
and
the
interest
in
See
United
The
rDNA
other
g;_Brien
technology
that
the
right
to
research
supra
was
note
v.
Court
would
O'Brien,
stated*
supra
raise
or
were
required
compelling
10, at
fMVIRJL
regulating
public
be
381-82
"should
of
state
367,
in
safety
the
States
U.S.
see_.alsg G r e e n ,
activities
regulating
Robertson,
391
interest
conduct);
as
protection,
§§£~a®Deral
18.
extent
If
constitutional
v. O'Brien,
or
not
a
note
be
threat
to
the
accorded
to
show
substantial.
1210.
391
U.S.
"CW3!>en
367,
"spafrcl.*
3/6
^
ionspeech*
«
v
e l ^ a S ,
:
*
._.
element
Amendment
freedoms
See
(per c u r i a m )
statute);
can
justify
v. New
and
See generally
"'inquiry'
clearly
intellectual
22.
see_also
See
(analogizing
time, p l a c e ,
Hear in g s ,
Emerson,
and
Yale
rDNA c o n t e x t ]
An
research
note
does
of
Law)
Human
Services
behavioral
research.
regulations
the p e r s o n a l
balance
and
(1977)
881
to be
(arguing
and
Rep.
directly
ss
the
(1941);
to
which
B u t .see
Professor
danger
DNA
Thomas
test
[in
acceptable").
45C.F.R.
benefit
when
0t.ti.nger)
danger
imposed).
present
that
activity").
569, 576
of
( s t a t e m e n t , of
("clear
(1942)
T e c h n o ] cigy
affecting
p r o m u l g a t e d ''by t h e D e p a r t m e n t
of
(1974)
protection
present
may be
human
integrity
n.9
1 3 0 7 ?•< n . 8 2 .
3:12 U . S .
and
to protect
the
First
drawn).
into hazardous
to clear
regulations
are regulations
on
560, 573
DNA
(statement
regulations
not. s e e m
the
unconstitutional
constitutional
3395
14, at
of
of
1 3 , at
836
Hampshire,
research
School
example
New
manner
supra
its
Rec.
rDNA
785,
is transformed
v.
1 2 4 Cong.,
note
Recombinant
Rev.
loses
Cox
supra
Note,
L.
discourse
sweep"
ends must be narrowly
21.
Sa.
405, 414
Hampshi re, 315 U.S.
See_general_l_Y. S p e c s ,
11
in r e g u l a t i n g
limitations
41S U.S.
limitless
20.
Assessment,
interest
f : D n d u c : t ?
Id.
"nearly
Chapl insky
,! , i l f ! : „,
incidental
v. Washington,
(noting
means
-
;..;„.,., f;al
. . . ."
Spence
(nexus b e t w e e n
and
.:«...'. ; t l l ,i
?
nonspeech
19.
are
subjects
4 6 . 10.t~.211
to society
human
f(?*«SS
of
subject
scientific
of
Health
in b i o m e d i c a l
(1985).
the research
involved.
and
These
with
See
I
generally
Lapps
ofjacience,
S . Cal .
regulations
Emerson
on
fundamental
however,
animals
Hearings,
Emerson,
Yale
23.
Cf._
freedom
right
utter
of
of
or
inquiry,
of
freedom
24.
See
Citizens
the
if
the
Recombinant
(statement
manner
2 5
of
and
•
:
on
serious
Professor
the right
read
(1923)
Bd.
425
DNA
Thomas
479, 482
not
(1965)
only
the
to distribute,
. . .
and
to teach
the
freedom
. . .
community");
of
indeed
Meyer
(statute forbidding
of
U.S.
suppressing
DNA
Pharmacy
748, 770
information,
available,
v.
German
Discussion
v.
Virginia
(1976)
and the
that the First
following
(choice
dangers
Amendment
Setlow,
How
M g l e c u 1 e^. _. C o m m i 1 1 e e _ W g r k s _ i n _ 1 9 7 ? ,
Genetic
Experimentation
(stating
scientific
See„generaliY
involving
so far").
includes
and freedom
State
E. Weiss)
restraints
but
to
See_generall.y
Recombinant..DNA
of
"a
unconstitutional).
is freely
us").
NI.H
was
of
makes for
done
381 U . S .
university
Council,
it
on
and has m o r e
been
press
print,
390, 403
dangers
of i t s m i s u s e
and
thought,
Virginia
Consumer
has
v. Connecticut,
entire
taught
is
of c o n t r o l s n o t
(statement
right
U.S.
language being
"between
the
Professor
reseach
goes further
that
(describing
research).
rDNA
level
(1978)
Law).
to
the
262
because
cell
speech
right t o r e c e i v e ,
Nebraska,
or
Griswold
of
that
14 at 9 1 2
School
1543-47
and behavioral
anything
note
("right of
the f r e e d o m
1535,
Ctlhat. r e a l l y
than
supra
to
L. Rev.
molecular
implications
I h e _ P l a c e . o f . the.. P u b l i c J i n . t h e ...Conduct
biomedical
argues,
humans or
& Martin,
Hoi man
general
research
8<
agreement
are
Dutton,
# n « s
161,
165
that
in
(1979)
time
and
constitutional.
A_._Case_._f g r _ _ P u b l i c
Participation
in
Cal-
1505,
L.
Rev.
scientists
and
B e i e n c e . . Pol. i c v .For mi j 1 a t i. on.. a n d „ P r a c t i c e , 5 1
1509-10
public
on
(1973)
whether
(describing
positions
experimentation
S.
o-f
should
be
regulated).
26.
Five
involved
vector
in
in
scientists
science
rDNA) .
were
involving
Watson,
Why
tumor
virologists
one
was
E s c h e r i c h i .a„cql i. ( t h e c o m m o n l y
used
the...."Berg"_ L e t t e r
B'ecpmbi n a n t J D N A . a n d ...Genet i c...Experi m e n t a t i o n
27.
Id._
28.
Discussion
at 2 3 6
Risk j
of
microbiology
and
were
moratorium
caution
Berg
letter,
following
Singer
study
clinical
of
Bg£Qfflbi.naQt_DNAs
Genetic
in
discussions
risks were
discovered
U w ,
Cal.
L.
30. ' Discussion
to
Rev.
190
note
in
(1979) .
1, at
8< S y b a l s k i ,
T h e ,_Public
Scientists
epidemiologic
surprised
by
because
1114.
supra
note
9,
Percept ion.
of
or
and
261,
diseases,
of
be
261
and
the
genetics
medical
overstated.
1167,
fallowing
1170
of
in
for
a
suggesting
rather
incitants.
in
296
infectious
suggestions
than
After
DNA
in
were
technology,
Halvorson,
DNA
experts
microbiology
rDNA
in
Lennette,
Recombinant
(1979).
risks
of
scientists
disease
289,
involved
aspects
the
the
biochemistry
^Experimentation
included
S.
supra
A„£ubiic_Health_yiewBoi.nt,
infectious
51
and
pathogens
epidemiology,
in
Warner,
Cohen).
guidelines
involved
187,
Wri t t e n ,
a n d ...Genet i c _ E x p e r i m e n t a t i o n
S.
greatly
and
were
DNA
of
Was
Watson).
following
Recombinant
(statement
diseases
see
J.
Discussion
in
(1979)
and
191;
(statement
29.
the
at
and
and
the
the
(1978).
Warner,
supra
note
29,
at
296
<
001 fi7
(statement
31.
Berg
of
At
told
the
-four d a y
on
41
restrictive
that
Playing
Fed.
because
the
of
self-interest.
Singer
told
restrictive,
controls
on
that
issued, h a z a r d s
did
else
not
scientific
drafters
S<
had
willingness
Szybalski,
it
for
them.
supra
IcL
low-level
when
risks
to
self-regulate,
and
lack
n o t e 9, at
were
of
224.
The
sufficiently
agencies would
Even
were
instructions
to
the guidelines
federal
technology.
restrictive
The guidelines
responsibility,
unless
the
do
Dr.
(1977).
(1976).
a
California,
impose
would
27,902
or
beyond
Asilomar,
they
3 10
social
Congress
rDNA
God
reflecting
acknowledgment
were
if
at
someone
Reg.
guidelines
drafters
meeting
themselves,
Goodf ield,
32.
draft
Cohen).
scientists
regulations
See J .
S.
impose
strict
the guidelines
associated
with
were
source
\
materials
Director
were
of
speculative
NIH
DNA M o l e c u l e s ,
33.
Atom.
See
41
Release
Fed.
Novick,
Scientists
inability
to
experiments
and
to
,are
desire
Reg.
27,902,
assessments
having
a
12,
of
"'trust
big
Recombinant
(1976).
personal
16
(May
rDNA
are
brother
(1)
and
(expressing
conviction
therefore
experiments
them);
(Nov.
that
1977)
between:
dangerous,
conduct
risks
27,904
on
the
16,
that
14
Research
of
33
are
can
Influence,
1978)
(public
Bull.
that
be
safe
see._a 1.so G r e e n ,
B^_Controversy.L_A„Model_of _Public
Scientists
for
Decision
Present_Control§_.Are_Just„a„Start,
not
to
unquantifiable.
Guidelines
distinguish
(2) c o n v i c t i o n
personal
and
rDNA
conducted;
because
of
Ihe_Recombinant
34
Bull.
tends
lower
than
originally
because
he
knows best'
to.
Atom.
regard
perceived
overtone").
as
34.
(1978);
See
see._al s o
scientists'
Wade,
King,
New_Di§ea5es.,,in..New
Zinder,
positions
supra
seemed
Niches, 276 Nature
note
6-7
(reversal
of
5,
at
16
irrational
to
public).
But
Ihe_.Roles...o£_God_and.. M a m m o n .in_Mal_ecular:_Biology,
G e n e t i c , E x e e r i. m e n t a t i o n . t o _ B i o t e c h n g
203, 2 0 8
are
4,
(1982)
(in
generally
scientific
accepted
on
their
o-f
the
in
gal
community,
o-f
From
T r a p s i t. i o n
scientists'
merits regardless
see
opinions
research's
sponsor).
The
regard
public's
is partially
The B e r g
were
image
letter
not
note 9 ,
was
flawed
not
subjected
at
231
of
this
were
on
logical
based
id.
at
to
224
fact,
peer
of
(May
1977)
When t h e
(some
public
was
generally
minds,
behavior
supra
(discussing
reversed
at
note
fact
Because
irrational.
See
imaginary
1977).
was
Monster,
14
fact).
of
hard
the
was
not
to have
open
Singer
molecular
technology
See
Rowe,
as
it
are trained
1976
actions
materialized,
around
An
(May
not
not
14,
basis
that
Watson,
was
Scientists
the
supra
5f.e__al.50
Zinder,
rDNA
theories
facts.
223.^see_a_lso
See
13
hard
9, at
that
12,
had
scientists
appeared
beliefs
Scientists
its
as to risks was construed
about-face.
that
their
35.
from
Atom.
this
science.
the scientists'
determined—on
the
of
public
Szybalski);
dangers
in
& Szybalski,
The
derived
W.
and
Singer
that
33 Bull.
suspected
skeptical
such
of
later
understood
Szybalski,
at 16
the
assumed
speculation
scientists
facts—that
review.
conclusions
GyidelingB_tbat_Do_the_Jsbt
document
J. Coombes) .
but
(statement
community
due to a misunderstanding
a scientific
(statement
made a w a r e
scientific
supra
note
&
5,
biologists
hazardous).
33
Bull.-
Atom.
lO
36.
See
Guidelines.
Fredrickson,
in
t h e .. U n i t e d _ S t a t . e s ,
Experimentation
37.
46
38.
biology.
of
the Risks
even
See
cannot
Churches
smaller
of
on
.8
Ethical._Conseguenc.es3;
discussions
note
9,
knowledge
239
on
part
public
36, at
at
has
formal
Concerns,
public
that
Only
a
training
in
in
molecular
National
Council
of
E n g i n e e r i.n.g--Social,
M. Rogers,
public
genetics);
of
training
thereinafter
elite
DNA
(arguing
had
had
Genetic.
152
meetings).
Bioethical
of
Recomhinant
town
has
(statement
of
with
percentage
see . also
molecular
at
DNA
(1981).
note
discussed
(1984)
bewilderment
on
59,39J
supra
Christ/USA,
Consequences
(describing
be
the
Fanel
Recombinant
i n R e c g m b i n a n t . . D N A ...and...Genetic
Associated
59,385,
of
.of. , _ t h e
(1979).
Fredrickson,
biology
an
Ethical
156
Reg.
percentage
biology;
the
Fed.
See
molecular
small
151,
Evaluation
Research,
A ... H i s t o r y
as
Biohazard
group
Singer
M. Singer)
regarding
cited
when
&
Socialand
179
(1977)
listening
Szybalski,
(commenting
science
and
on
and
to
supra
lack
of
scientific
method).
39.
See
Involving
(1985)
Notice
Recombinant
(comment
by
Biology)
("Ch3ow
becomes
a
research
eer_.se").
40.
benefits
of
matter
See
is
J.
DNA
Dr.
the
Actions
Molecules,
B. Horecker,
results
for
not
of
NIH
50
supra
scientific
9i.-_Unrestric.ted_. Research.:.
Jhe
Guidelines
Fed.
Roche
such
regulation,
Goodfield,
social,
Under
note
Institute
reseach
but
not
31,
decision);
Case
M T T M
Reg.
are
for
Research
9760,
of
Molecular
implemented
the conduct
at
146
Novick,
9762
of
the
(degree
of
Jhe..Dangers
of .....Recombinant—DNA,
in
1
Recombi nant
(risks
and
41.
...DNAs.... S c i e n c e , . . E t h i c s , _ a n d
benefits
See
G.
of
basic
Nossal,
125-26
legislation
to
Chairmanj'.s
Introduction,
42.
(role
of
public
34
tends
to
43.
Virginia
Rep.
are
of
the
Dutton,
and
Citiz en
by
iin
drafting
and
Geneti.c
regulations
are
research).
supra
note
trivialized
by
25,
at
1531
expertise
Court
in..t h e_. R e c o m b i n a n t
37,
(Oct.
42
scientists
1978)
when
of
DNA
(public
technical
or
discussed).
of
supra
Professor
note
16,
M.
Shapo,
University
of
3395
(1978)
(statement
of
Law)<
Cong.
Congressman
themselves
saying
speak.'
American
45.
that
developing
Scientists
e._g.., 1 2 4
think
you
&
Genetic
Szybalski,
DNA
RecgmbiDant_DNA._Resea.rch
See,
attitude."
A
Atom.
Ottinger).
whereof
the
be
(statement
the e x p e r t s ^ '
the
undermined
issues
apparently
(arguing
rapidly
intimidated
School
44.
(1979)
in
technology);
Recombinant
can
be
100-01
in
( 1978)
quantifiable).
di f f i c u l t i e s
changing
Hoi man
Krimsky,
See
(outlining
e . g...,
Bull.
scientific
147
controlling
See,
Debate,
at
147,
in
scientists) ;
(1985)
regulate
Experimentation
are not
Reshapi.ng...Li_f e s . _ K e y . . I . s s u e s
Engineering
impractical
research
P o l i t i c s 71 , 7 2 - 7 3
public
will
Ottinger
omniscient
goes,
I resent
Rec.
"and
that,
and
you
and
destroy
stated:
"CScientistsl
infallible.
can't
possibly
I resent
you
if
note
25,
'We're
understand
it e x t r e m e l y ;
you
maintain
and
that
IcL
See
Hoi man
cumulative
&
Dutton,
experience
of
supra
human
history
at
1520
because
(science
is
scientists
\9L
base their
46.
the
work
See
Debate
Rev.
on
efforts
Engelhardt,
Concerning
1141,
1150
Determi.nati.gns,
theory
of
Green,
43 Geo.
consent
discussion
of
of
engineered
organisms
political
consent,
IdA
set of
654,
654
actual
47.
in
L. Rev.
(1975)..
used
Bok,
If h a r m f u l
would
not
who
that
to
of
a
limited
by
given
the
declined
to
the
research.
Fiction,
technology
variety
shown
and
Fact... a n d
rDNA
in
not
of
The
genetically
be
were
consequences
large
Freedgm
impractical
as those people who
(arguing
in a
791, 792
probably
R e c o m b i n a n t . . DNA.:
ri^ks have been
See
'.Calculus
people
as well
(1977)
techniques
no
The.. . R i s k - B e n e f i t
they
Thus,
in
L.
be unable to avoid
Cohen,
Sgme„Backgrgund_Issues
technology.
escape,
consent,
would
But_see
Science
that
to
others).
S. Cal.
is
rDNA
boundaries.
opportunity
of
R e c o m b i n a n t . D N A „ R e s e a r c h , 51
informed
risks
experiences
Taking._Risks:
(1978);
Safety
and
195
is merely
a
experiments—and
exist).
Ri.sk, 1 0 7 D a e d a l u s
115,
118-19
(1978).
48.
See
M.
Lappe,
Brgken._Cgde:
The_.Exe.lgitation_gf„.DNA
178
(1984).
49.
The
throughout
term
this
technology.
Article
The
term
only to r e p l a c i n g
Sciences.
A
(1978).
Current
organisms.
"genetically
to mean
"genetic
genes
Biologist!!?
See
Yale L . & Pol'y
papular
Thomas,
Rev.
in
engineered
organisms
Perspective,
usage
of
Over view?
309, 309
used
by
historically
referred
See
Baltimore,
Limiting
107
Daedalus
the
term
37,
refers
rDNA
39-40
to
all
R e g u l a t i.P.g. B i o t e c h n g l o g y ,
(1985).
(10172
is
manipulated
engineering"
people.
organism"
3
1,
50.
See
51.
Ida.
52.
See
1984
Halvorson,
at
Recombinant
53.
ad
at
hoc
DNA
45
Advisory
consultant
to
"The..ExEerts.":
Perceived....Risks
235,
previously
on a g e n e t i c a l l y
release
experiment,
submitted
to
the
Rgl.ease.Iest,
54.
made
231
on.
Cgmmercej.
1065
Advancement
of
[hereinafter
Professor
1986,
technology
cited
has
thp
science
it r e l e a s e
to test
informati-on
Cong.,
Massachusetts
pendulum
in
"gee
with
1st
direct
it
had
Legislative
and
approach
skepticism;
mistakes
will
00173
Sess.
Institute
whiz"
and
wildly,
bury
and
the
A s s o c i a t i o n _ f or.... t h e
Hearings]
the press swings
technology
data
on _Sc i en c e j _ R e se arch
A m e r i. c a n
Diamond,
replaced
in a
and _ T r a n s p o r t at ion ^
Ri s k / B e n e f i t
been
and
96th
media's
Monsanto,
(1986).
as
that
Versus
Qn.._.Scienc.e_and_Techngl o g y
with.. _.. t h e
Science,
Edwin
(explaining
that
all
Actual
IechnglggyJL_and_Space_gf _the_Senate
Science,.
For u m
'.'..The
S u n , M o n s a n t o O p e n s , F i l e o n ...Genet i c
1065,
gn__.Scien.ee,
Congr e s s /S c i e n c e .
"Cals
that
it w i s h e d
nearly
l Q d . „ T e c h n g l ogy_.of ...the_Hguse_.Comm-
Comm.
of
In M a r c h
J o i n t ...Hearings^Bef|or e „ t h e . , S u b c o m m .
Sub comm.
June
Cornell
Li c h t e n s t e i n ,
S e e . g e n e r a l l y R i s k / B e n e f i t ._Analysi.s_in._the
Process:
the
?<
suggestion
microbe
See
Science
Slovic
(1981).
public
EPA.
Pimentel,
o-f
RAC).
EPA's
engineered
D.
in Ihe„Analysi.s
246-47
fought
of
Minutes
P e r c e i v e d . . v s . __Act.ua1 J D i s a g r e e m e n t s
About„!5Lsks..pl^NucLear_Power,
had
1178.
Committee,
(statement
S e e . g e n e r a l_l.y F i s c h o f f ,
Pyblic"_„ys.
which
n o t e 2 9 , at
1177.
Meeting
University,
supra
42
(1979)
(statement
of
Technology)
to science
commenting
the public
us").
of
and
that
fe^2s
55-
S e e , . e..g._
Recombinant
DNA
perception
56.
Renort__ot_„IBC
Technical
o-f r i s k s
can
Bull.
be
DNA
Procedures,
7
Changing
Manipulation
Recombinant
26, 26
(1981)
DNA
a n d .....the
Technical
supra
note 42,
Cambridge
citizen
court
in r e v i e w i n g
57.
See
by
al.sg
124
Ottinger)
Cong.
arguments
45
S. Cal.
Rec.
("Cooperation
3395
and
Hazards
lay
42
and
of
(1984)
people
in
(describing
safety
of
rDNA
MIT).
C o n t r o l _ o f _ S c i ences.
L. Rev.
(1978)
596,>611
(statement
explanation—in
of
these
113
of
at
at H a r v a r d
The_.Freedgms_and._the
Not.es._f r g m . . . t h e . . . I y g r y _ I o w e r ,
see
of
scientists
Lederberg,
in
107,
Krimsky,
conducted
quality
Bull.
committee);
experiments
(difference
Regulation,
local
of
4
of. _the
preparedness
success
and
Views
(praising
rDNA
Meeti ng,
substantial).
Se.ej._ej._g..., L e v i n ,
Recombinant
Qhairpersgnls
English,
(1972);
of
Rep.
rather
than
\
in s c i e n t i f i c
jargon—is
what
elitism.
If
offering,
not
direction,
CtheyD
than
Cthey3
58.
wxl.I
have
See
ever
that
regulation
59.
Yale L.
60.
seen
general.!*
§iohazard_Debate,
(arguing
invite
3
if
Yale
to
the
scientific
[scientists!
vastly
date
Carter,
L.
scientists
&
more
. . .
community
do
not
should
move
serious mistrust
Pol' y
do
Rev.
not
win
358,
public
360
See
Singer,
Genetics_and_the_Lawi_A„ScieDtist_'..s
See
Green,
supra
.
(1985)
confidence,
will
315,
. .
I h e _ . B e ! 1.m#n t ._the„Sn.ark 4 ,._an.d._..the
science
Rev.
that
.").
of
8< P o l ' y
in
be
increase).
326-34
note
33,
nc!_ •:ntt-rid . DN.^ t e c h n o l o g y
3
(1985).
at
13
(even
h-'"'
m74
View,
if
'
scientists
•>
did
15
,l;le); s e B . s i s n
Genetic..;
daoiP.yi3ti.gns,
Experimentation
we
who
first
to u s t h a t
to
a
37,
there
See
avoid
own
the public
Chalker
at
and
physical
research
would
now has
Another
right
due
right
of
the
of
note
in
46,
risks
science
and
Recombinant_DNA_:_
(1978)
at
commentator
1145
has
Robertson,
the right
"ends"
the
(personal
(discussing
distinguished
means.
crrzs
to choose
note
the
of
research
the
being
of
10,
means
between
regulation
stricter
supra
research,
to that
"means"
analyses,
the
L.J.
EthicalTheories
188-89
is similar
the
to
__NEPA
1978 Duke
t o c h o o s e t h e e n d s of h e r
r i s k , and
subject
regulation
the
may be downplaying
Williams,
the means.
with
In b o t h
be
is
A n a l ysi.s_.. of
cripple American
177,
supra
distinction
social
it
is
motives).
this analysis,
risk,
risk.
than w o u l d
\t>
to
"would
good
to choose
The
physical
comparable
of
risk).
Under
IdL
Case
scientists
Politics
scientist's
1206.
weaker.
that
Engelhardt,
freedom
and
("It.
or o t h e r w i s e
Recgmbinant_DNA_.Controversy,
is evidence
a
the public
A
ambitions");
sacrifice
and t h e
Cats:,
particular
the
Scientific
H. Kornberg)
the validity
that
of
of
NIH„and„DN£LEecgmbinant...Research,
Ethi.csJU_^and
between
of
Laboratory
D N A ..and
to possible risks,
concern:
&
(suggesting
See
Bert. sr. i ,
original)).
Science,.
ambiguity
(statement
regulation
Underlying
62.
ft ill o w i n g
Recombinant
(1979)
assessment
Implementat.ion.:.„.
58, 87 n . 1 4 8
in
is public
(emphasis
61.
their
44
alerted
critical
dangers."
to
Di sriBsi".n
social
being
comparable'
t h e e n d s of
constitutional
is
to
the
scrutiny
63.
S o c i a l ,_.and . E t h i c a l . _ C o
64.
See,
gugted_J,n
mankind
is
But
(arguing
9760,
that
that
"genetic
But
see
Involving
9762
Wisconsin—Madison)
prohibition
view
of
threatened
on
on Behalf
("Mr.
Rifkin
grounds.
is
of
In d o i n g
sorely
50
1181,
1194
Business
303
the
(1980)
public.
fed.
for
Reg.
University
for
this he
limited
Research!
NTH Guidelines
asking
of
understand).
in
Smithies,
is
and
by men
447 U.S.
not
UNESCO,
man
People's
Molecules,
0,
of
. . .
Actions Under
by
II t o
L. Rev.
CisD
DNA
(comment
moral
morality
of
3 8 , at. 2 5 .
andBasic
S. Cal.
engineering
Notice
Paul
("future
v. Chakrabarty,
Recombinant
(1985)
11.9
note
are dangerous to
Brief
States
John
Regulation
no phenomena
e.g.., A m i c u s
United
interest").
4 1 , at
o f . . . R e c o m b i n a n t ...DNA, 51
See,
Commission,
Pope
radically
see Grobstein,
(arguing
65.
by
note
threatened,
IC5B.L?.catiQQS.
Research
Address
B. Nossal , supra
science").
(1978)
e.g..,
supra
a
blanket
shows that
. . . ."
of
his
(emphasis
original)).
66.
gee
F. 31, 34
Novick,
(Nov.
1985)
life is t a m p e r e d
67.
S. C a l .
Se&
iyECa
benefit
Fletcher,
rDNA
note
of
hypothetical
(describing
64,
imagined
h o r r o r s of
Envtl.
future
if
with).
L. Rev.
implement
What„Is_Wrong_.with..Biotechnology?,
1131,
technology
at
Ethi cs_and„Recombi.nant _DNA_Research,
51
1133
to
has moral
1191-92
new
knowledge
and
equally
(1978)
(stating
limits).
§ut._see
("nonquantifiable
must
take priority
nonquantifiable").
that
but
over
right
Grobstein,
time-tested
risks that
are
63.
Problems
Splicing
Genetic
See
President's
in
Medicine
Life,
and
A Report
Engineering
C o m m i s s i or. f o r
Biomedical
on
with
the
in H u m a n _ B e n e t i c _ E n g i n e e r i n g : s
Investigatigns
lechnologv,
Human
97th
"playing
because
.
"all
."
genetic
the
God
for
(Nov.
Sess.
78
(J 9 8 2 )
activities,
scientific
interfere
The
commission
concluding
intrinsically
See
Science
DNA Technical
that
Miller
or
141,
Id..
at
72.
Dr.
Lewis Thomas
the
Rifkin,
155
71.
accept
or
using
supra
don't,
surprising
useful
or
that
proceed
processes
laws
it
were
organisms
natural
that
as
of
nature
"could
find
pi a r m e d
forms
material,
human
or
nonhuman
per
se. "
Id..
of
at. 1 0 5 .
Environmental,.
Bigtechnglogy,
8 Recombi nant
(1985).
note
10, at
18-19.
251.
you
overwhelming
promptly
current
stated
splicing
1he_Attitudes..of...Religious,
J.
science
any
stated
irreligious
70.
have
further
and
cited
scientists
the descriptive
Pol ic y _ L e a d e r s _ I g w a r d s
Bull.
gene
on
on...Science
engineered
thril: d e s c r i b e
with
whether
wrong
that
genetically
laws
can
t h e . ..Subcomm.
The commission
including
of
reprinted.
thereinafter
thought
manufacturing
Issues
1982),
of..the H o u s e . C o m m .
religious
engineering,
69.
the
in
Id._
no g r o u n d
some
human
to
only
. . .
and
2d
Ethical
Research,
Ethical
Hearings_Before
Oversight
Cong.,
to
God"
according
are
Beings
of
Behavioral
and
Genetic..Engineering...Hearings3 .
it w a s h u b r i s
. .
and
Study
and
Social
Human
the
and
bits."
and
described
and
if
you
disturbing
upheaving
Thomas,
the
have
it you
p i e c e s of
ones,
N o t e s ..of ..a
CftT?
problem:
along
"You
are
either
obliged
information,
with
the
neat
to
even
and
Bilglgg.y-Watch.er , . — J h e
IS
Hazar.ds_.of..Science,
recognized
been
that
twisted
science
we
concluded
biologic
what
•
discussions
the
i s s u e of
should
not
be
that
sorts
to
» . •"
73.
because
medical
things
be
grateful
Id_._
at
See
324, 327
(1977).
regulating
rDNA
technology
whether
"we
we
at
still
far
too
be
making
learning
whatever
Lewis,
74.
See
O r t_h o b i.os i s A
75.
Fletcher,
1,
18-19
174
Lewis
ignorant
about
learning
we can
get
Cin
. . .
hold,
of
(1984);
see
.also
in
Zimmerman,
supra
been
note 67,
of
Man,
(1978)
-(suppressing
successful).
at
1137
(citing
i n The_Pl.ace_gf
Lederberg,
Value
in
3
(1970)).
when
judgments
should
not
if
had
Singer
has never
I h e . P e r f, e c t i o n
Thus,
they
325.
in
D N A:. ..Two ..Views of _.th e . F u t y r e , i n R e c o m b i n a n t
knowledge
W o r l d _ o i .. F a c t s
things
Ihe._Li m i t a t . i o n s ...of ...Med.i.cine...as....a._.Sc..ie.nce,
DNA.:.„ S c i e n c e,. __E t h i c s A a n d _ P o l i t i c s 2 7 3 , 2 9 9
of
had
judgments
or not
snatches
Lewis
o>26.
Recomb inan t
acquisition
"some
Id._
to begin
should
for
there were
about."
are
sciences]
of
J. Med.
learning
J h e _ £!.§ D i E y I .§.t i on... o f _ Li. f e
Beyond
on
into
and
we o u g h t
296 N. Eng.
scientists
be
entitled
been
given
by
8< S z y b a l s k i ,
sugra
note
give
to any
any
value
judgments,
greater
credibility
other
9,
at
member
231
of
their
than
society.
(statement
of
See
J.
C o o m b e s ) ..
76.
ids 7 2 - 7 3
(disputina
77.
See
B.
(il984).
value
It
Zimmerman,
But_see
Cavalieri,
f r e e r o l e of
is r e a l i z e d ,
Biof yturex_Cgnlrgnting_.the_Beneti
of
modern
course,
supra
note
6,
at
1165
science).
that
00178
the accomplished
design
II
of a t e c h n o l o g y
Hearings,
member
of
field
of
envision
could
can
supra
impel
note
Science
for
research
how
16,
is
of
technology
leading
illusory,
Recs®binant„pNA.._Research
(statement
of
Scott
However, unless a
prohibited,
of
Graham
fundamental
because
Thacher,
particular
it i s d i f f i c u l t
to the design
Professor
controlling
is
310
totally
limited.
al t e r n a t i v e
at
See
the People).
knowledge
be
its use.
a new
technology
stated
that
research
it a s s u m e s t h e
to
"Ctlhe
instead
impossible:
of
the
%
foreseeing
Co.nceCDS
of
the
results
About._._Science
Daedalus
1,
78.
11
See
approaches
79.
fundamental
and ^ At tenets
inquiry."
Graham,
to_Regulate_Inguiry,
107
(1978).
Grobstein,
use,
See
are r e d u c e d
of
supra
benefits
Novick,
and
become
supra
defused
note
64,
at
1190
(as
knowledge
quantifiable).
n o t e 6 6 , at 35
"by expanding
the
(political
circle
of
questions
scientific
light").
80.
See
has m o n o p o l y
made
that
enforced.
Hal vorsop-,
on
a
acquisition
ban
As one
There
on
and where
When
is not
research
bodies seriously
will
they
not
allow
must
do
is somebody
dollars
2 9 , at
knowledge).
faintly
like nuclear
a billion
note
1168-69
An
could
(no
argument
not
be
country
can
be
effectively
wrote:
is something
and
of
rDNA
observer
law-making
will
supra
about
discussing
biologists
august
what
they
to do with
DNA
it.
going
bomb
and
ludicrous
to tell
research
a major
them
where
facility
that
one
to
this
needs
get
a.o
started?
that
E.
a
Letter
in
would
called
is
dedicated
coli
sky
When
his
see
(and
somebody
amateur
own
would
difficulty
disproving
a
of
new
from
M.
kind
might
cellar,
nothing?
why
going
and
Even
to tell
graft botulism
all
if
the
spies
the village
he?), he
would
that
was merely
one
them
have
to
in
the
policeman
great
developing
soup.
Thackray,
34
Bull.
Atom.
1978).
180
Scientists
7,
7
(Feb
Bl.
Evaluation
of
46 Fed.
Reg.
Research,
this
Article
the Risks Associated
59,385, 59,386
it h a s b e e n
technology.
This
assumed
assumption
that
with Recombinant
(198T).
there
are
to
from
practical,
the
Three
the
Science)
societal
analyses
industrial
its
should
use
characterization
including
of
probability
environment
process.
the
&
Genetic ..Technologies,
A
development,
of
or
main
at
beneficial
to man
original)).
in a r i s k
assessment,
(1)
and
is revealed,
and
L. Rev.
461, 479-80
been
the
process
defined
or
other
as
etc.,
its
possible
estimation
in
the
of
the
Emerging
man-made
results
in
an
regardless
question
Novick,
and
(1983).
biosphere,
substance
species."
of
"any
that
terrestrial
or
thorough
byproducts
Vand.
of
organism,
an
Regulation
of
a
engineered
organisms,
products
(1985)
(emphasis
(3) r i s k s t o o r g a n i s m s
substance,
modification
the
and
115
nonexistent
Federal
process,
not
harm
rDNA
"are
technology:
other
in
of
Szybalski,
112,
Bayer,
has
inadvertent
whether
if
harm;
36
biohazard
view"
genetically
chemical
McGarity
82.
rDNA
(2)
for
of
Cf,.
technology
be conducted
to harm
byproducts;
of
point
the
ability
and
ir, r D N A
of
of
products
the
(risks
purposes
risks
may be unfounded.
8 e n e t i_c . . E n g i n e e r i.ng_i n . . . A g r i c u l t u r e , 2 2 9 S c i e n c e
(letter
For
DNA
i s in
the
note
40,
Recombinant
DNA
supra
79.
B3.
Evaluation
Research,
84.
46 Fed.
Reg.
Discussion
(statement
of
H.
of
the Risks Associated
59,385, 59,386
following
Kornberg).
Bertani,
with
(1981).
supra
note
60,
at
44
85.
Discussion
(statement
86.
that
formulas
since
in
not
time
that
example,
work
factors
atomic
in
1978).
of
Influence,
regulated,
but
that s c i e n c e
purely
that
per
note
Health, Law
Science) ;
energy
was
Risk
("model s ' a n d
in t h e n a t u r a l
environment,
does not mark
Atomic
See Atomic
the
first
energy,
Energy
Act
for
of
1946
755, 766.
One
difference
in
rDNA
technology
viewed
scientists
34
Bull.
has
1946 and
in
being
Atomic
research
of
been
a
military
willing
to be
technique
context,
regulated.
103
(statement
Values,
research
^t. 1 2 ,
12,
been
(Nov.
periodically
regulated
15, and
subject
15
is the first
comprehensively
has been
See
Scientists
has
rDNA
c o n t e x t , see__id._
application.
and
to
I h e „ R e c o m b ! n a n t . _ . D N A _ . . C o n t r g y e r s y : _ _ A . . M g d e l _...gf.
se
16, at
t.o
Z. Harsanyi)
research
1946.
atomic
229
is the only way
(letter
regulated.
the regulation
civilian
its
164
involved").
RDNA
in
scientific
a scientific
before
at
.§nd_ t h e .__ E n v i r a n merit s
are
been
energy
atomic
Other
24,
Biotechngl.sgy„and„the_Environment
7 9 - 5 8 5 , .60 S t a t .
See._general.ly G r e e n ,
Public
of
regulated
regulation
resulting
are safe")
situations
has
L. No.
now is that
note
testing
( s t a t e m e n t , of
in
regulation
was
between
(1985)
science
10, P u b .
organisms
Harsanyi ,
unique
The
("Cflield
Biotechnology
15, 22
so many
87.
(1985)
following
will
supra
G e n e t i c _ : _ E n g i . n e e r i n g „...AQ_..__Agriculture,
recombinant
Regulation
s
U S
Overview,
Setlow,
Rolleston).
Brill,
115,
Discussion
An
F.
See
Science
prove
of
following
to
the
time
in
first
close
a
time
scrutiny
RecombinaDt_PNA_Research_.Hearings,
of
California
M. Lappe,
Department
fft«2
Chief,
of
Office
of
Health).
ai
Regulation
a
trend
regulating
being
promulgated
Ex o r c i.st s _ v s .
(Nov./Dec.
may be the culmination
prospectively,
earlier
and
earlier.
Charfas,
following
H. S t e t t e n )
Man-Made
.Life
Set.low, s u p r a
(commenting
that
132
(1982);
n o t e 2 4 , at
no actuarial
164
data
to
conduct
one risk
assessment
NIH s p e n t
$250,000
converting
a farmer
chemical
facility
in
Dedrick, Maryland,
Fort
States
standards.
Fort
that
The
at
the
Dedrick.
suit
v. Califano,
90.
(1985);
91.
met
worst
the guidelines'
case
laboratory
See
S.
risk
24
was challenged
Krimsky,
Genetic
was resolved
447 F. Supp.
See H.R.
Berg
668, 670
Rep.
letter,
National
No.
supra
99,
note
Research
later
99th
1, at
Council,
Id...
at
93.
See
Col w e l l ,
to
residents
in f a v o r
of
be
of
The_Social
(1982).
The
NIH.
Mack
1978).
Cong.,
1st
Sess.
13
303.
Risk
38
Assessment,...in.
(1983)
a s Risk._.Assessment_in_the.JFede
92.
in
containment
Alchemy:.
(D.D.C.
warfare
scheduled
two
the
laboratory
246-47
two years
of
exist).
and germ,
test
by
also
experiment,
strictest
assessment
Eederal _Goyernment:._.Managin.g_the
cited
23
(statement
into the only
tiiitory._of _ t h e . . R e c o m b i n a n t_DNA...Co
ensuing
Ruber
see
of r i s k s
In o r d e r
conducted
See
in
1983).
Discussion
the U n i t e d
of
resulting
G a t e k e e p e r s ...in R i s k R e g u 1 a t i o n , R e g u l a t i o n
J.
89.
research
towards
regulations
88.
o-f s c i e n t i f i c
the
[hereinafter
.
19.
£ e n e t i c__Engi.neering„
Norse,
Pimentel,
Sharpies
229 Science
111,
&
Simberloff,
111
(1985)
(letter
to
94.
Science) .
See
H ..R._
Demonstration...Act__of_
Natural
Resources,..
Hguse„SommA
(1984)
of J . R o d r i c k s ,
1?S4;
1983,
Hearings
.6gri£i4J.fcurg
cited
Environ
Council
See
(statement
in t h e
of
Public
97.
See
91,
at
98.
Assessment
Before.
on
M.
and
the...__Subcgm_m. __ _ o n
R e i e a ! l c h _ a Q ^ _ g Q y i r o n m e n t _ o f ,_t.he
C o n g . , 2d
Sess.
58
(statement
Corporation) .
Environmental
Risk
Research
a s Risk...Assessment...Heari.n.gs 1
Fiftgenth_Annual_.Rep.grt
96.
note
I h g _ JRi sk
o n _ S c_ien c e _ a n d . . T e c h n o 1 g g v , 9 8 t h
thereinafter
95.
4192,.
217
Assessment
Jacobson,
Quality,
(1986)
(emphasis
Heatings,
Executive
EnvironmentalQuality
supra
Director,
original).
note
Center
94,
for
at
105
Science
Interest).
Ri.sk
Assessment
in_the_Federal ^government,
supra
164.
See_id...
at
33-37;
see
. also
Panei
Discussign--T.he
Weaknesses_and_Strengtk|s_gf _Wgrst_Case„Analysis^
Qecisign_Process,
Analysis
Federal
risk
101,
112
Activities,
assessment
tentative
99.
Use
in
Values
in Prgceedings_gf_a
(statement
EPA)
knows
art
as
much
See
Ashford,
Regulatory.
72, 77-78
:
of
as
A. Hirsch,
("Ca3nyone
that
it
it
is a
that
has
is a highly
gg
Wgrst.
Director,
been
Case
Office
involved
judgmental,
of
in
highly
science").
Advisgry_Cgmmittees_in_OSHA._and_EPA£_Their
Decisionmafciag,
(Winter
5C£: S l a v i c ,
Sympgsium
9
Sci . , T e c h n o l o g y
&
Hua.ar,
1984).
Fisi^J.wff
Si
mm
Bisk—Assessment.:.
a
l5=.Lliiiil-5il
sLLUi
Hearings,
supra
101.
Sghavi_nr al.—Issues,
n o t e 5 4 , at 133,
See M.
Sagoff,
reprinted
See
R i , s k - B e n e f it
(statement
of
103.
Program
in H u m a n
Risk
at 210
Biology,
Stanford
Assessment...in
supra
note
of P r o f e s s o r
54,
at
184
Research).
W.
Lowrance,
University).
the„Federal_6gyernment,
S e e x _ _ e . g._, R l s k _ A s s e s s m e n t _ . H e a r i n g s ,
(describing
Administration);
assessments
106.
in
Federal
use
supra
note
Federal
(1982)
(1982)
See
F.2d 4 6 7 , 4 7 4 - 7 5
(no r i s k
(D.C.
instead
facts).
Ledarbarq,
use
See
who
was
a
for
and
at
Drug
of
risk
A c t , 21
U.S.C.
food
Rodenticide
Toxic Substances
Union
supra
member
additives);
Act, 7
Control
U.S.C.
Act,
15
Dep't., A F L - C I O v . H o d g s o n ,
499
(balancing).
19740
scientific
Lederberg,
and
(1982)
Cir.
and Cosmetic
permitted
Fungicide,
Industrial
significant,
108.
in F o o d
(describing
Food, Drug
(balancing);
involving
of
assessments
2.89-300
ss 2603(a), 2605(a)
107.
risk
supra, note 94,
EPA).
Insecticide,
s 136(bb)
of
i . d a t
E,.g._
s 348(c)(3)(A)
U.S.C.
(1985) .
Associate, Decision
(statement
.Decisions
33.
105.
430—37
id.
A n a l ysi.s__.in_
Hearings,
P. Slavic, Research
See
104.
91, at
Risk/Benefit
Risk/Benefit.
136-37.
C o n c e r n i n g _ P u b 1 ic...Saf ety._and H e a l t h 2 4
102.
in.
(decisionmaking
uncertainty
note
of
. tM'&ciEz.
57,
expert
is based
at.
in
issues
on
policy
609-10..
Dr.
panels
evaluating
SlL
environmental
members
were
Therefore,
did
not
fact,
even
provide
Dr.
of.
at
members
an
supra
entail
a
that
note
46,
at
or
lesser
Food
Drug
cost
degree
L.J.
460,
computer
to q u a n t i t a t e
the
or
uncertainty
ethical
issues
uncertainty
109.
of
(statement
a beginning
be
not
in
costs..
demanded
of
program
Academy
del i vered
risk-benefit,
may
that
even
analyses
political,
deciding
("A
inheres
whether
or
.the...Real.
mathematical
eventually
relevant
such
r e p r i n t e d . in
1973),
(1973)
In
detail."
National
social,
466
panel
be
in
able
a
given
to the moral
that
and
risk
or
acceptable.").
Science
William
fits
into
risk-benefit
is
involved
See
(statement
. . .
is
it
with
Safety„Regulation_i.n
or
but
the
in t e c h n i c a l
and
of
formula
Cexperiment3,
was
(May
benefit/risk
risk
benefits
panel
precisely.
Is Saf.e^?, a d d r e s s
Hutt,
Cosm.
of
Intrgducti on_to
("All
cf._
benefits
cloaked
Forum
799
that
conscientiously,
"what
judgment,
Sciences
judgment.");
28
acted
o n ...."How... S a f e
of
stated
analyse
balancing
believes
Forum
greater
ethical
accurate
a policy
Academy
Green,
World,
though
energy,
to
§ee...also. H a n d l e r ,
Sci e n c e s
National
nuclear
unable
was
6105
from
often
Lederberg
committees
Id.,
radiation
Lowrance,
the
analysis
of
Donald
flow
of
Policy
Report,
Department
category
does
not
Michael,
data
supra
of
have
of
those
an
note
15,
a risk-benefit
of
37
State)
("DNA
issue
issues
where
formal
application");
University
at
Michigan)
analysis
alone
id.
at.
39
("even
with
would
not
adequate").
The
regulation
if r e g u l a t i o n s
Green
were
questioned
of
rDNA
based
whether
on
technology
could
a risk-benefit
"obvious
and
foreseeably
analysis.
important
expected
be
eased
Professor
benefits
3i7
induce
the
a decision
-face
the_Laws
1033,
o-f u n c e r t a i n
110.
must
id..
has
F. 7, 8
in
Green, Technology .Assessment
and
(Jan.
1986)
by
accept
are
more
EPA?_.s
public
popular
management.
19, 24
36 Geo-
Communicating
viewed
Yuhnke,
F.
o-f a t e c h n o l o g y
Ward,
(describing
to
risks"?
development
Wash.
L.
Rev.
(1968).
See
be
risk
with
Intrpductio^
1041
Envtl.
to proceed
as
impartial
perception
and
Environmental
(risk a s s e s s m e n t
merely
risk
on
and
to gain
"that
-fancy w a y s
1985)
(arguing
that
management
assessment ' and
the public
(emphasis
it
original));
A . Cr.iti.gue, 4
policy
4
a c c e p t a n c e ) ; cf..
of t e l l i n g
Ri.sk_ A s s e s s m e n t ..Process,......,
(July
risk
risk
more pollution"
Risk,
decisions
Envtl.
in
risk
risk
being
<
management
made by
See
T e c h n i cal.
Hearings,
of
and
agencies
Behavioral
note 54,
See
(statement
in d e c i s i o n s
at
of
Professor
133,
Congress).
Risk
in
Assessment!.
Risk/Benefi.t
137.
Hearings,
supra
H. Green, George
note
54,
Washington
at
37
University
Law).
See
Ashford,
114.
See
R^sk_Assessment„Hgati.Qgs,
from
P.
Environment,
Subcomm.
of
repri nted
113.
(letter
environmental
& Lichtenstein,
Issues,
Risk/Benefit.
on
instead
SI.ovic, F i s c h o f f
supra
112.
and
resulted
administrative
111.
School
have
on
Advisory ;Board,
supra
note
99, at
Deisler, Jr., Vice
Shell
Oil
Company
Environmental
Industrial
Union
73.
supra
President
to
S.
Cflfl?
94,
of
Health,
Samuels,
Carcinogenesis,
Department,
note
at
Safety
Chairman,
National
AFL-CIO
256
(Jan
Cancer
19,
a
1982)).
115.
provides
Human
42
U.S.C.
a broad
grant
Services
provides
power
to conduct
to regulate
The
original
but
statement
following
and
(1976) .
Impact
did
Research
DNA
not
in
refer
Statement,
35 Food
Health
and
Section
2421
264
provides
to any
statutory
the environmental
See National
Research
41
impact,
Institutes
Guidelines,
Fed.
Reg.
Draft
38,426,
38,427
T.he ,_N.I H,„.6u
and_the_ Authority
WLfeh„the_Gui.de_!.ines,
241
of
Section
publication.
S e e ...generally K o r w e k ,
Section
diseases.
was provided
their
(1982).
research.
cooperation.
Recombinant
Environmental
264
encourage
communicable
authority
Health,
2421,
to the Secretary
guidelines
authority,
DNA
of
241,
-for i n t . e r n a t i o n a l
authority
of
55
gf„ihe_FDA..jto_Reguire_ggmpliaQce
Drug
Cosm.
L.J.
633,
636
8<
n . 16
Recombinant
DNA
(1980).
116.
16 U . S . C .
ss 4321-4361
117.
National
Institutes
Research,
33,067
Proposed
(1978).
the O f f i c e
a
Id.
of
The
coordinator
Health,
43
secretary
DNA Activities
and
Fed.
Reg.
33,042,
of t h e R A C i s D i r e c t o r
(ORDA)
clearinghouse
at N I H .
for rDNA
DRDA
of
is
activities.
33,068.
"Guidelines"
guidelines
National
of
Guidelines,
executive
Recombinant
nationwide
at
Revised
(1982).
were
is
issued
Institutes
Guidelines,
41
probably
Fed.
of
after
a
notice
Health,
Reg.
misnomer.
27,902,
and
comment
Recombinant
27,902
The
original
procedures.
DNA
(1976).
Research
The
current
version
o-f
contains
Health,
Mol e c u l e s ,
. . -
mandatory
Guidelines
51
Fed.
cannot
information"
projects
the N I H
note
involving
Guidelines"
at
guidelines,
46 F e d .
of
Reg.
described
as
Institutes
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than
59,391
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Meeting
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118.
Research
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health,
National
Other
law,
and
51
of
41
Fed.
Fed.
as
regulations.
DNA
process."
Research;
17,167
been
National
(1982).
1984)
well;
have
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precatory
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they have been
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6,
of
Research,
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of
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modified
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Recombinant
Reg.
27,902
(1976).
as
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health,
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16,958,
fiV
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occupational
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flexibility.").
the environment
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fields
Institutes
Guidelines,
17,166,
on t h e evolution
National
119.
DMA
have worked
this degree
with
designation
treated
regulatory
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at>' 30
despite
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E-.q;..» M i n u t e s
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would
(1931).
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however,
must comply
with Recombinant
Recombinant
scientists,
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of
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guidelines
59,385,
47
are
16,965
added)).
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submission
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Risks
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i t ( 1 9 8 6 )
recombinant
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National
Involving
without
added));
restrictions
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16,958,
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Research
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108,
for
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be
language.
DNA
(1986).
on the
RAC.
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Apart
from
^ o
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Fed.
DNA
Reg.
proposed
Research;
696
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See
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i n_
the
1979,
161,
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and
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that
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11
members,
the
members.
of
Molecule
and
had
time
Institutes
Recombinant
DNA
1978 the RAC
Since
National
Institutes
Revised
numer
Id_._
Health,
Molecules,
51
has
The"'RAC
Guielines
Fed.
Reg.
of
Health,
Guidelines,
43
Recombinant
Fed.
Reg.
DNA
33,042,
(1978).
See
126.
National
Involving
Korwek,
supra
note
Institutes
Recombinant
DNtt
of
115,
at
648.
Health,
Molecules,
Guidelines
51
Fed.
for
Research
Reg.
16,958,
(1986).
127.
Id...
128.
Id;.
implements
the
institutions
Some
the NIH
comments
49
(1986).
125.
16,965
Guidelines,
from
Recombinant
(1979).
voting
members.
156,964
124.
162
include
voting
Research
16,958,
quotes
NIH;
in
Experimentation.
25
Under
amendments.
123.
has
Actions
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guidelines
receiving
private
Guidelines
ordinances.
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by
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is
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grants.
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due
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on
fncn
agency,
self-enforcement
by
16,962.
may
be required
guidelines'
S. Krimsky,
regulatory
supra
adoption
note
89,
to
follow
by
local
at
294-311
3\
(1982).
129.
DNA
See,
Research;
Environmental
(1985)
etat,
Request
Impact
(voluntary
The federal
private
proposal
Court
companies
Splicing:
Comments
need
NIH.
50
Fed.
withdrawn
for
National
of H e a l t h ,
on N e e d
for
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a
Reg.
during
14,794,
RAC review
not
obtain
approval
of
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252, 252
process).
held
that
release
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of H e a l t h , G u i d e l i n e s
D N A M o l e c u l e s , 51 F e d .
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NIH_Wi_ns_<2...Round, 2 2 9 S c i e n c e
130.
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from
for
Institutes
Statement,
District
experiments
National
Reg.
for
Research
19.598
19,959
(1986).
131.
See
Zoon,
Regulation
F.C9dy.5ts_and_Synthetic„Peptid.es,
384
of _ _ R e c g m b i n a n t
37 Food
Drug
Cosm.
DNA-Deri_ved
L.J..
382,
(1982).
132.
Research
See
National
Guidelines,
133.
IcL
134.
Id..
135.
National
Research,
at
Revised
41
Institutes
Fed.
Reg.
of
Health, Recombinant
27,902, 27,915
DNA
(1976).
27,907.
Institutes
of
Guidelines,
-43
Health,
Fed.
Recombinant
Reg.
60,080,
DNA
60,108
(1978).
136.
major
Deliberate
action
requirement
for
by
advice
release
the
of
experiment
Director,
the RAC,
id.,
as well
00191.
waivers
thus
as for
were
termed
triggering
the
opportunity
for
comments
by
federal
agencies
Institutes
of
Health,
Recombinant
DNA
Molecules,
137.
National
Research,
Revised
and
the
Guidelines
51
Fed.
for
Reg.
Institutes
Guidelines,
public.
of
43
See
National
Research
16,958,
Health,
Fed.
Involving
16,960
<1986).
Recombinant
Reg.
60,080,
DNA
60,083
(1978).
138.
National
Involving
16,960
&
Recombinant
16,984-85
cultivated
(2)
Institutes
crops
plants,
of
or
enumerated
Exempt
a genus
the
plants;
with
plants
(3)
DNA
no
and
Fed.
which
(4)
Research
16,958,
(1) s p e c i e s
no noxious
of
for
Reg.
include:
sequences
plants,
specifications;
Guidelines
51
containing
introduced
genes
Health,
Molecules,
(1986).
well-characterized
animals,
DNA
of
weed
is
species;
composed
harmful
the DNA vector
of
plants
in
grown
of
, to
of
people,
which
meets
controlled
\
access
fields
Id..
at
16,985.
one
of
these
granted
Group
by
of
DNA
Director
cumbersome,
be
and
unavoidable
technology
and
experiments.
guidelines
conditions
acting
and
in
the
consultation
of
46 Fed.
recognizes
detailed,"
because
Id.,.
failed.
but
of
59,391.
National
IBC.
the
59,385,
the
Plant
that
this
rapidly-growing
A
1981
Institutes
fif-192
can
be
Working
Associated
59,385
guidelines
of
by
Id..
Reg.
realizes
the
with
IBC.
is covered
the experiment
Risks
that
appropriate
plant
the
impossibility
at
for
appropriate
Research,
by the
engineered
approval
Evaluation
the
reviewed
a genetically
categories,
RAC,
See
Recombinant
The
If
ORDA,
the
139.
under
covering
proposal
of
with
(1981).
are
"long,
situation
nature
all
to
Health,
of
may
rDNA
possible
abolish
the
Recombinant
33
DNA
Research;
17,173
UnderGuirielir.es,
47 Fed.
Reg.
17,166,
for
Research
Reg.
16,958,
(1982).
140.
Involving
16,961
Actions
National
Institutes
Recombinant
DNA
of
Health, Guidelines
Molecules,
51
Fed.
(1986).
141.
Research;
See
National
Final
Recombinant
DNA
Institutes
of
DNA R e s e a r c h :
Institutes
Plan
for
Research,
Health,
a
46 Fed.
First
Health,
Program
Program
Proposed
of
to
Reg.
Recombinant
Assess
30,772
the Risks
(1981);
t o A s s e s s t h e R i s k s of
Annual
DNA
Update, 45 Fed.
of
National
Recombinant
Reg.
61,874
(1980).
142.
Set low,
subcommittee
supra
is only
one
note
of
123, at
several
162.
The risk
subcommittees
assessment
of
the
RAC.
Id._
143.
See
SEerations,
144.
Krimsky,
4 Recombinant
See
Talbot,
Wilson
&
DNA Technical
King
8<
Boyer,
l!5BLementing_Institutional .Oversight,
Bull.
19,
145.
176
19
La.
communicable
Shinnick,
public
219
by r e l i a b l e
Louisiana
1977)
disease
health
Bull.
Jhe
Procedures
24, 25
IBC
as
4 Recombinant
and
(1981).
a
DNA
Means
of
Technical
(1981).
SeeJL_eigii,
(E.D.
Milewski,
F.
to protect
is broad
Supp.
officials
showing
(power
of
that
v. Matthews,
and
risk
public
flexible);
789, 79
(E.D.N.Y.
existed
error).
00193
427 F.
can
Supp.
against
174,
spread
of
United
States
v.
1963)
(judgment
of
only be
superseded
146.
Health,
12,
Cf._
Letter
Education,
1978),
Recombinant
and
DNA
Federal
Interagency
that
concluding
to
all
Revised
Committee
on
rDNA
Institutes
research
Fed.
Reg.
that
the
Research
comprehensively
products
Health,
wrote
DNA
o-f
(Sept.
of
43
Califano
Recombinant
361
Secretary
Kennedy
Guidelines,
Secretary
section
Jr.,
Edward
National
(197S).
apply
that
Califano,
to Senator
in
Research,
60,104-05
Joseph
Welfare
reprinted..
60,104,
found
from
caused
or
had
would
entail
could
cause
%
human
disease.
tenuous.
Id..;
The
see
committee
42
U.S.C.
Environmental
Defense
Council,
to
to
Inc.
Hold
the
Hearings
Fund,
s 264
(1982).
Inc.
and
Secretary
and
considered
of
a
But.see
Natural
Health,
Promulgate
such
conclusion
Petition
Resources
Education,
Regulations
Defense
and
Under
of
Welfare
the. Public
f
Health
Service
reprinted
that
Act
i.n,
DN_A__H_eari n g s ,
"CbUecause
activities
may
recognized
that
transportation
communicable
to
sy&cs
all
note
DNA
spread
DtffA
all
at
See
81
Jhe
@§Q§tic . E n g i n e e r i n g ,
Sybstagces
and
disease
("HEW
the
(arguing
s 361
risk
of
authority
Chal ker
authority
been
control
the same
the
DNA
to
?s. C a t z ,
regulate
activities").
Potential
Hea.ri.ngs
Envi rgnmental
cited
under
activities");
has
274
it h a s a l r e a d y
[the Secretary!
DNA
Activities,
recombinant
[therefore:
gives
iQyLConment_and_Pub.li.c_Wgrks,
thereinafter
by
humans,
promulgated
clearly
DNA
14, at 2 6 0 ,
produced
materials
. . .
note
amom
recombinant
recombinant
147.
supra
regulations
of
61,
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fAicroorganisms
disease
regulate
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Before
the
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Qversight.gf _the_Senate_Cgmm._:_gn
98th
Cong.,
2d
Sess.
as Pgtential_Cgnseg.uences_Hearingl
00194
22
(1984)
(statement
3 5
Of T .
McGarity,
143.
Professor
Gore
2< O w e n s ,
L. & Pol * y R e v .
149.
Consider
Reg.
336,
National
for
Law, University
of
Texas
at
Austin).
T h e . C h a l l e n g e , of ...Biotechnology,
345
3
Vale
(1985).
Institutes
Environmental
12,456
150.
of
of
Health,
Proposed
Testing
of
Advisory
Committee.
Points
Microorganisms,
50
to
Fed.
(1985).
Recombinant
1984 M e e t i n g
at
33
DNA
(response
of
Working
Minutes
Group
of
on R e l e a s e
June
into
1.
the
Envi r o n m e n t ) .
151.
See
Korwek,
152.
See
Karny,
supra
note
115, at 634
Regul ati on.
of
GSD£eCD_fifelSMi_EcanBgDStSiDS-.feyt_Jiffle
Production,
Role,
12.
supra
Toledo
note
$408 million
153.
to
6,
at
L.
41
research
See
S.
krimsky,
regulation
of
scientific
interests
of
its
research
sets
community.
See
155.
See
standards
old
risks).
scientific
precedent
840
year
to
note
does
89,
not
by
C o m m e r c i al^
see._al.so
NIH
NIH
contributed
biotechnology).
at
234.
merely
constituency.
disliked
go
(1981);
1984
related
supra
research
fi£t,ign
the
NIH's
affect
The regulation
entire
the
of
scientific
Id..
154.
BeguLation,
a
own
815,
(in f i s c a l
directly
G e n e t ic_Eng.in.f.eri ng:__.Less
„f o r
Rev.
n.7.
69
M.
Lappe,
supra
general.!y
note- 4 8 ,
Huber,
Va.
L.
Rev.
1025
imposed
on
new
risks
at
29.
Ihe_._01drNew__Piyi sign_in_Risk
(1983)
with
©01S5
(contrasting
lower
standards
stricter
imposed
on
156.
National
Research
Fed.
6588
Guidelines,
Reg.
final
Institutes
38,426
EIS
was
(1977).
guidelines
believed
draft
were
publishing
(1976).
published
The
that
Draft
the
the
Notice
in
the
was
publication
Discussion
following
of
Impact
the
the
would
when
pending
were
Mack
v.
Califano,
F.
Reg.
original
served
by
instead4
of
the
EIS.
Introduction,
147,
447
the
EIS
of
Chairmanls
R e c o m b i nant_.DNA__and_Geo.et i c „ E x ^
157.
ready
41
the
better
completion
Szybalski,
the
preparing
be
they
of
42 Fed.
after
scientists
DNA
Statement,
availability
published
interest
guidelines
withholding
Recombinant
F e d e r a l ...Register.
because
public
Health,
Environmental
EIS
issued
of
Supp.
153-54
668,
in
(1979) .
670
(D.D.C.
1978).
158.
Assessment
Research
33,096
Impact
National
of
Institutes
a Proposal
Involving
(1978);
of
159.
the
Recombinant
Final
F.
vacated__in_part,
756
DNA
NIH
Institutes
of
Health,
Supp.
(D.D.C.
1984),
F.2d
762.
161.
Id.,
at
768.
162.
Id.,
at
764.
163.
756
F.2d
at
753
143
(D.C.
Cir.
Impact
Guidelines
Molecules,
Reg.
at
at
Revised
43 Fed.
Id...
IdL
Health, Environmental
Guidelines,
160.
164.
to Release
National
587
of
43
Fed.
for
Reg.
Environmental
60,101
(1978).
affLd_in_.gart_and
1985).
154.
153-54.
Judge
Sirica
AA1P6
held
that
NIH
was
not
3'
enforcing
direct
any
release
binding
on
document.
equivalent
165.
the
statutory
experiments.
Director,
Therefore,
of
or
NEPA.
587
756
F. 2d
Id,,
at
at
and
the
requlatn™
eguiatory standards
The
was not
(citinn
iciting
a
•
review
recorded
process
F. Supp.
154
RAr
RAC
w a s
t
n o t
in
permitting
process, was
in an
t h
.
not
environmental
f u n c t i Q n a l
7^6.
an
48 Fed.
Reg.
24,548,
24,548
(1983)).
166.
158.
00197
3?
167.
Id._
at
159-60.
168.
Compare
National
Impact
Assessment
for R e s e a r c h
33,096,
of
33,110
if
National
Proposal
Involving
all
the
requirements
Policy
of-
Guidelines,
48
Fed.
Reg.
is
to
Drs.
Steven
of
of
Health,
for
Act)
24,548,
are
Guidelines
Fed.
Reg.
release
with
be
of
the
National
Actions
(1983)
release
Under
("Permission
Nickolas Panopoulos
to
into
can
(and t h o s e
DNA Research;
and
Berkeley,
43
met")
24,549-50
Lindow
NIH
organisms
a waiver
Recombinant
California,
Environmental
deliberate
recombi nant-DNA-ccntaining
Institutes
University
Health,
DNA Molecules,
("prohibition
Environmental
granted
of
to Release Revised
Recombinant
(1978)
the e n v i r o n m e n t , of
waived
a
Institutes
under-
of
the
specified
(
•conditions
Pseudgmonas
carrying
in_vitro
involved
in
ice
169.
756
170.
See
Activities
generated
syringae
deletions
of
and
all
E r w i n.i a
or
part
herbicola
of
the
genes
nucleation.").
F.2d
at
154.
National
Under
Recombinant
pv.
DNA
NIH
Institutes
Guidelines
Molecules,
45
of
Health,
for
Fed.
Notice
Research
Reg.
of
Involving
25,548,
25,548-50
(1983).
171.
116,
756
121-22
equivalence
409
F.2d
functional
172.
F . 2d
(D.
at
Md.
doctrine);
1247,
1257
equivalence
-See
Cooper,
154;
see
1976)
Maryland
F.
(citing, cases supporting
Environmental
(D-C.
v. Train, 415
Cir.
Defense
1973)
Fund,
functional
Inc.
(outlining
Supp.
v.
EPA,
elements.of
doctrine).
Ihe__ImEact„_gf __Bigtechnglggy„gn___the
00198
P h a r m a c e u t ical
.Industry,
R i s k „ & _ R e g u l at ion
61,
69
Bi.otBchnnlpay._and.. t h e E n y i r o n m e n t :
(1985) .
173.
756
F.2d
174.
See
NIH„RecombinaQt..Advisory_Rp]Le
Sci.
&
Gov't.
at
i r.
153.
Rep.
5, 5
(May
15,
Gains
1985)
Eniends,
Cherei naf ter
15
cited
as
Adyisgry_Rgle3.
175.
Under
See
NIH
48 Fed.
to spray
The natural
at
form
had
deleted.
been
of
Idt
approval
by
concerns.
Id..
reviewed
revised
taken
to
Heckler,
of
756
in
proposal
and
approved
RAC
by
revised
requested
143
Wilderness/Scotchman's
at 4 4 ,
(D.C.
Peak
that
effects
Brief
1985);
Grizzly
nucleation
of
several
Federal.
had
also
Committee,
24,549.
experiment
implies
that
the Regents
be
RAC
had
of
the
Economic
Trends
Cabinet.
Mountains
Bears v. Peterson,
flfl1S9
its
specified
which
the
for
see
of
in t h e
DNA
had
time
to the
Recombinant
at
plants
engineered
which
published
Foundation
Cir.
at
IdL
on
the experiment
proposal,
the USDA
at t h e p r o p o s a l .
for
ice
due to concerns
was
environmental
in
aim
bacteria.
ice to nucleate
to respond
by the RAC.
had
California
F„2d
The
approved
that
look
However,
revised
9441.
engineered
1982,
DNA
experiment's
involved
October
Actions
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The
The proposal
was revised
mitigate
a hard
University
24,549.
on
The genetically
genes
proposal
at
was subsequently
The fact
the
recommended.
the
caused
to -5 C.
of
the RAC
The
Register.
0
Involving
genetically
bacteria
part
at,
was
RAC m e m b e r s ,
been
or
Health, Notices
(1983).
plants with
the
of
Research
24,548
between
all
reviewed
for
Reg.
potato
temperatures
bacteria
Institutes
Guidelines
Molecules,
was
National
685
v.
F.2d
40
678, 684
<D.C.
Biosafety
National
Cir.
1982).
concerns
Institutes
had
of
o-f N o S i g n i f i c a n t
Steven
Lindow
Berkeley).
not
include
that
that
many
Kolata,
How
Safe
(1985)
the
Cf.
(application
University
engineers
o-f
experiment,
M. Lappe,
plans
reaction
supra
t.o
release
ecologists
engineered
and
of
Drs.
California,
however,
note
did
4 8 , at
do not understand
of
See
Assessment
to
34,
to
Nov i ck,
Pgl_i_ti_cs 1 0 3 ,
112
are
their
outside
in
(1978)
organisms);
Ruse,
The
A
Rec.gmbin.ant.. DNA:... S c i e n c e A | _ E t h i c s x
(arguing
expertise
34
molecular
D a n g e r s _ o f _ U n r e s t ri_c ted... R e s e a r c h
Response
179
ecology);
A r e ...Engineered. . . O r g a n i s m s ? , 2 2 9 S c i e n c e
(describing
biologists'
7
approved
genetic
by the proposal.
Environmental
Panopoulos,
ecologists.
(arguing
(1985)
Impact
Nicholas
The RAC
addressed
Health,
Finding
?/
been
that, m o s t
when
molecular
discussing
and
biologists
dangers
of
rDNA
technology).
176.
Under
See
NIH
45 Fed.
177.
id..
National
Actions
for
Reg.
received);
Research;
Institutes
Guidelines
Molecules,
comment
National
Health, Notice
Research
Involving
25,548, 25,549
at
1157
Guidelines,
of
(one
Actions
DNA
favorable
received).
Health,
49 Fed.
of
Recombinant
(1983)
(no c o m m e n t s
Institutes
Under
of
Recombinant
Reg.
24,548,
DNA
24,549
(1983).
178.
See
generally
Qyersight_gf „Heal th_and
Envtl.
L.
Rev.
standard
is
that
Rodgers,
Environmental
191, 213
of
Be.nefi.ts,..
(1980)
maximum
C o s t s,__ and._Risks:_
D e c i si. g o m a k i. n g ,
("NEPA's dominant
4
Harv.
substantive
Friends
of
Endangered
1985)
(concluding
issuing
agency
and
Species,
an
had
Inc.
that
agency
Environmental
"conducted
imposed
179.
v. Jantzen, 760 F.2d
specific
See
(1976);
Vieux
Pierce,
719
F.2d
756
181.
National
Assessment
mitigation
F.2d
and
v.
at
1282
Finding
California,
organisms
Drs.
risk
has been
genetically
termed
183.
and
in
Karny,
of
390,
St
Health,
2<
410
n.21
Assocs.
v.
Environmental
Impact
3
Nickolas
releasing
than
that
having
Perpich
A
(1985)
Panopoulos,
chemically
involved
the
8<
Discussion
Institutes
Finding
(application
by
University
California,
of
action
in
same
Levin,
192,
mutated
releasing
composition.
Environmental
194-95
(1985)
Levin).
National
Assessment
that
1983).
Lindow
organisms
Biotechnology:
M.
Residents
Significant
greater
Asjje c t s
of
finding
Berkeley).
following
(statement
No
Steven
Discussion
glf.
upon
Club, 427 U.S.
(5th C i r .
involved
engineered
not
measures").
Owners
of
University
The
in
reasonably
Statement"
Institutes
by
182.
Cir.
153.
(application
of
"acted
(9th
a n a l y s i s of t h e p r o p o s e d
Sierra
Property
1272,
180.
Impact
a thorough
Kleppe
Carre
had
976, 987
Drs.
Singer,
of
No
Steven
184.
See
185.;
E . g._, B a l t i m o r e
of
Health,
Significant
Lindow
&
Environmental
Impact
Nickolas
44
(19B5)
Panopoulos,
Berkeley).
supra
n o t e 5 3 , at
Gas & Elec.
332.
Co.
v. Natural
Resources
Defense
633
Council,
(D.C.
Cir.
186.
(en
See
banc)
or
Ethyl
when
conflicting
knowledge"),
(agency
because
denied,
1975)
Society
1301,
(2d
1303
ultimate
facts
AFL-CIO
v. Hodgson,
to
of
were
denied,
informed
insufficient
factual
circumstance
less upon
187.
purely
that
reviewing
agency
courts
at the
supra
178, at
note
(D.C.
is
based
492,
of
be
519-20
medical
scientific
v. OSHA, 509
Cir.
F.2d
because
knowledge"),
Industrial
(D.C.
1980)
must
on
scientific
(1975);
United
Cir.
evidence
Inc.
of
Union
1974)
of t h e s e
Dep't
("CSlome
standards
knowledge, and consequently
is presently
available
Decision
making
extent upon
to make
must,
policy
as
a
fully
in
that
judgments
and
analysis.").
must
f r o n t i e r s of
216-18
Co.,
b e at their
determinations
expertise,
see_al so
to agency's decision
Baltimgre_Gas_&__Eleci
(stating
1259
in t h e p r o m u l g a t i o n
to a greater
factual
(1976);
"frontiers
467, 474
determination.
depend
See
data
effect"
scientific
Indus.,
scientific
Cir.)
t h e f r o n t i e r s of
the
992
and
v. EPA, 514 F.2d
"frontiers
499 F.2d
of
cause
scientific
on
(D.C.
uncertain,
1139,
(deferring
invc^Ved
of
1, 2 8
to agency decision
U.S.
the frontiers
them
F.2d
to come by,
941
Co.
Plastics
on
421
the questions
are on
on
Mining
Cir.)
cert;.
of
647 F.2d
conclusions
knowledge");
on
426 U.S.
(deferring
scientific
is
based
Reserve
proof
Cisl difficult
it
v. Marshall,
to);
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( 1 9 S 3 ) , rey.'.g 6 8 5
97
v. EPA, 541 F.2d
step-by-step
determination
deferred
and
Corp.
"evidence
cert,.
Steel w o r k e r s
87,
1982).
("rigorous
not r e q u i r e d
462 U . S .
Inc.,
"within
mm
at
103
"most deferential"
when
CtheirD
science").
(discussing
462
U.S.
area
of
special
See_.generally
Rodgers,
"soft glance"
standard
of
&
judicial
review);
Comment,
Vermont
UBt»eLds„NRCls„S-3„Iabl.e„for
10,239,
10,242
deference
to
District
of
scientific
(1983)
agency
See
Assessment
Circuit's
13
Envtl .
contrast
involving
scientific
finding
102
(1982);
(criticizing
701
in
that
South
F.2d
"unpredictable
2
Issues
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agency
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had
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in S c i .
Co.
of
versus
ignored
judicial
District
280 F.2d
Reactor
Dev.
U.S.
cf..
(statement
Howard
of
and
the
Cir.
courts
756
F.2d
190.•
Id.
at
1960,
rev^d
as
at
154.
Appeals)
will
153
ever
n.6.
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of
sub
creating
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United
&
hope that
Mach.
risk
54,
States
to assess
Power
own
note
in
United
ngm,.
its
supra
undertake
decision
Elec., Radio
trust and
(1981)
Workers v.
Hearings,
C I
to
489, 512-13
Circuit's
396
Patent
Safety
leading
decisions);
Rev.
Union
Markey, Chief
scientific
the._ ...Need ._.__ f o r
International
(1961),
98-99
Prods.
as
Elec., Radio & Mach.
Risk/Benefit
189.
L.
Columbia
(D.C.
v.
assessment)j
nor
of
645
Co.
367
Customs
of
Union
States,
Harv.
93,
of
v. Consumer
uncontrollable"
Scientific
?< T e c h .
treatment
1983),
94
Technology
?< M e r r i l l ,
Cir.
Refgrm,
International
Congress
Court's
Assessmentand
blgh_.T.echngl ggy__and._the_Cgurts.t_Nu c l e a r
of
Rep.
issues
Pglitics
Circuit
Insulation
1137
and
The
s e e ...also A b r a h a m
the_Cgurts,
Gulf
Workers,
L.
in S u p r e m e
Ihe„CgurtsJ__„ Technology
D.i s p u t . e s ,
in
1986)
Comm'n,
finding
O'Brien,
79,
Uncertainty
in
Time,
(discussing
Columbia
Sciences-Policy
data
.Second
Court
uncertainties).
188.
(Winter
Yankee Revisit:ed:_High
at
98
Court
neither
science.").
191.
Jeremy
Economic
Rifkin,
Trends,
experiment,
potential
sued
his
main
effect
of
the
Ice
precipitation.
Tf
replaced
by
capacity,
The
stated
ice-nucleating
and
not
bacteria
230
192. •756
F.2d
turn
722, 741
on
knowledge,
at
(D.C.
choices
predictions
not
F.2d
of
we will
'findings'
Sun,
demand
of
an
matters
adequate
the
that
reduced.
1338,
are
Odum,
ft.
1338
(1985)
whose work Rifkin
relied,
were not cause for
was only
concern.
between
the
circumstantial
(1985).
1974)
with
affect
capacity
The relationship
But_see
pol^.£y, o n
on
EPA_.Approyes_Field._Test._gf ..Altered
1015
145.
Cir.
dealing
that
the
without
be
229 Science
xperiments
1015,
atmosphere
bacteria
on
on
bacteria
ice-nucleating
and precipitation
See
Science
the
on
California
experiment
foreseeably
stated
o-f
engineered
the
The researcher
also
the
engineered
small
Foundation
University
to
with
the_ B i o s p h e r e ,
proven.
Microbes,
in
could
that
researcher
the
genetically
bacteria
to Science).
however,
stop
nuclei
rainfall
organization,
objection
genetically
Biotechnology.,and
(letter
to
based
precipitation.
whose
sort
Amoco Oil
(Wright, J.)
assessment
Co.
v.
(when
of
EPA,
501
"regulations
risks,
on t h e f r o n t i e r s of
or
scientific
reasons and explanations,
familiar
from
the
on
but
world
of
adjudication").
193.
1st S e s s .
194.
756
6
F.2d
at
145
(citing
S-
Rep.
No.
296,
91st
Cong.,
<1969)>-
National
Institutes
Research;
Availability
Comment;
• Request
for
of
of
Health,
Environmental
Comments
on
Recombinant
Assessment
Need
for
a
for
DNA
Public
Programmatic
4s
Environmental
Impact
Statement,
50
Fed.
Reg.
14,794,
14,795
(19S5).
195.
See
reprinted„in
report
on
1969
NEPA)
technological
Senate
"resource
on
of
91st
Cong.,
1st
are
the
not
There
between
1191,
no
1191
science.
to
124
(1982).
actions
for
and
often
in t h e f o r m
scientific
technology,
in
its
The
knowledge"
No.
are
of
and
296,
typical
technology;
research. <
science
is that
and
urbanization,
impacts
These
(House
unforeseen
scientific
illconceived
between
2758
and
the
between
technology,
or
line
is
basic
Biotechnology,
and
229
that
applied
Science
(1985).
Caldwell,
See
499
decisions]
"unplanned
,
matter)!
(1969).
of
line
subject
S. Rep.
Excursions
L.
to e n s u r e
separate
science
Sees.
information
degradation."
draw"
197.
Agency,
of
1st
News 2751,
research
"quest
In r D N A
Fredrickson,
198.
as
the
impacts
196.
Policy_Act
"basic
13
bright
Koshland,
Ad.
pollution,
Sess.
impassible
science.
from
application
is
basic
"almost
to
environmental
typical
378, 91st Cong.,
described
depletion,
aspects
they
No.
Code Cong.
NEPA
arising
other
of
U.S.
(referring
report
results
Rep.
implementation"
consequences"
as
H.R.
Jones
F.2d
that
supra
v.
502,
outweighed
the
512
(D.C.
would
public
their
36,
at
153.
Science_and_the_Natigna^
District
decisions
that
note
of Columbia
Cir.
be
1974)
made
benefits
environmental
Redevelopment
("NEPA
only
flowing
costs");
002^5
was
Land
intended
after
[informed
from
[federal!
Calvert
Cliffs'
Coordinating
1971)
("NEPA
balancing
211
Comm.
v.
mandates
a
analysis").
(although
mandated
by
a
AEC,
449
rather
See
courts
1109,
finally
tuned
generally
cost-benefit
NEPA,
F.2d
have
Rodgers,
analysis
construed
and
Cir.
'systemic'
supra
is
the
ill?. ( B . C .
note
not
17S,
at
specifically
statute
as
requiring
one) .
199.
1983)
the
Cf,_
Johnston
(cost-benefit
decisionmaker
when
benefits
200.
analysis
with
were
v. Davis,
an
supra
Alexander,
Department
to
the
absence
allow
for
from
tests
a
reliable
Implications
may
of
to
or
body
provide
not
happen
seealso
and
Cornell
in t h e
M.
of
University)
scientific
is
Potential
(statement
information
absence
on
of
data
individual
utterly
98th
Cong.,
of
1st
the
Sess.
the
Su_bcgmm._
House
Comm..
218
(1983)
Ridge
National
I am
public
alternatives"
in n a t u r e . " ) ;
Oak
. .
22
and
Enyirgnmentai_Impiicatigns_Hearing1
.
at
of
as
("Although
Cir.
foolhardy
to
Environmental
o f „_Genet i c._Engi n e e r i ng:_.._Hearinq__Be^
and.. T e c h n o l o g y
Igchngiggy,
153;
it
9D_I.Dy®stiga_tigns__and_0_ver
Research
(10th
the
of
information
organisms,
may
at
Agronomy,
predictions,
engineered
what
36,
147,
note
substantive
designed
genetically
anticipate
of
1095
"to p r o v i d e
comparison
note
supra
("In
1088,
u n r e a l i s t i c a l 1 y) .
GSQseguences_Hearing,
Professor,
F.2d
failed
informed
described
Fredrickson,
698
I am
not
Laboratory)
a firm
believer
convinced
point.
There
is
anvthing
other
than
not
an
that
enough
in t h e
an
EIS
value
would
concrete
extremely
generic
Science,.
g n __Sc i e n c e _ a n d
thereinafter
(letter
(answering
gn.
from
F.
committee
of
impact
help
much
cited
Sharpies,
questions)
statements
at
information
available
treatment
. . . . " ) .
fl(i?f«6
this
for
*
201.
See,
e . g_._,
National
Environmental
Impact
NIH G u i d e l i n e s
-for R e s e a r c h
43
Fed.
Reg.
33,096,
is i n v e s t i g a t i o n
whether
cannot
("fallowing
Institutes
of
("At
fully
Statement,
202.
Science
the
For
thereinafter
and
of
as
13.
204.
I d j,
at
12.
205.
National
Request
for
Impact
J., concurring)
of
the
of
time.");
Reg.
of
id.
National
Guidelines,
Draft
38,426,
are,
1976 EIS,
F . 2d
C o n g . , 2d
of
the
of
38,431
course,
see Chalker
20
&
on
("programmatic
Need
50 Fed.
EIS
at
this time
on
19B4)
Report!.
Recombinant
for
But_see_id.,
Comm.
Print
Assessment
Reg.
on
Environmental
(Comm.
Health,
Environmental
159-60.
The
Implications
of
Statement,
Subcomm.
to the House
Sess-,
Engineering
Comments
at
by
transmitted
Institutes
Availability
756
research,
combination
applications
Environmental
at
206.
98th
Genetic
cited
Environmental
of
speculative");
Fed.
Prepared
Oversight,
Id..
Comment;
practical
Report
203.
Research;
definition,
some
DNA Research
a criticism
Technology,
Implications
by
61.
Staff
ana
is
41
Molecules,
ti
note
investigations
or
Revised
DNA
results
ahead
risks!
Impact
speculative.").
supra
predicted
Recombinant
me
Catz,
The
Health
to Release
("Research,
detrimental,
Caf
o-f
Recombinant
(1978)
Health,
this
a Proposal
unknown.
neutral,
discussion
of
Involving
33,102
the
be
Environmental'
(1976)
of
beneficial,
these,
Assessment
Institutes
a
for
DNA
Public
Programmatic
14,794
(1985).
at
(MacKinnon,
161
would
be
neither
justified,
practical,
207.
Consider
R e g
.
National
for
applications
in
Institutes
on
a
The
case-by-case
has
nicheCs
viability
escape
field
the
Recombinant
Assessment
DNA
for
Environmental
14,794,
(1985).
granted
permission
environmental
Consider
new
is
data
intended
to
collected.
Microorganisms
Modified
^BBLicai onSj
Document,
208.
Medical
by
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Advisory
at
Research,
DNA A d v i s o r y
of
9
(statement
aa
Committee,
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hoc
of
» 8
Id..
NIH
no
Oct.
common
Points
to
modified
as
of
to._. C o n s i d e r
107
(1985).
of
May
3,
member).
Institute
to committee);
1984
had
Techniques:.
committee
29,
a
Reg.
Jesting
DNA
McGarrity,
Health,
Fed.
Committee, Minutes
G.
to
Need" f o r
which
"Points
R. Clowes,
of
50
102,
site],
of
oo
Field
Bull.
consultant
Minutes
McGarrity).
of
including
Environmental
can be easily
Milewski,
of
of
for
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DNA
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Institutes
identified.
Development
review
organisms]
for C o m m e n t s
a guide that
Fed.
variables
Points to Consider,
Recombinant
7
the novel
experiments
Technical
at
the
variables,,
Statement,
DNA
Id;,
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and
of
to
experiment
National
B Recombinant
1985 M e e t i n g
209.
Issues,
[of
50
to
12,456.
the
Impact
been
be
are
at
issuing
had
at
distinct
Request
In t h e
before
effect
Td.
Availability
Comment;
Points
continue
because
ability
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Programmatic
will
basis
site."
Proposed
Microorganisms,
RAC
its own
and
test
Public
14,795
of
available
pathogenicity,
from
Health,
experiments.
experiment
"ecological
of
Testing
(1985).
individual
Every
prudent").
Environmental
12,456
involved
nor
for
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Meeting
at
8
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M
210.
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1995 M e e t i n g
at
211.
40
Peterson,
753
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212.
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754,
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758
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s
1508.25(a)(2)
F.2d
court
that
timber
the
construction
at
760
667-76
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Peterson:
10,289,
of
of
not
have
(1985);
not
a road
Davis
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reviewing
been
to
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the
NIH
direct
unnecessary
to
if
publish
Thomas
F.2d
661,
Thomas
Into
v.
did
they
forest.
v.
CEQ^s
15 E n v t l .
L.
Rep.
Peterson).
not
intend
proposals,
guidance
v.
because
Life
NIH
experiment
The
Hapke,
New
for
Thomas
521
Ihgmas
situation,
release
cft
Coleman,
and_CgnQ.ected_Actigns_Regulatigns,
(1905)
but
a national
generally
taken
experiments,
1985).
through
Breathes
have
occurred.
uncertain
v.
See
Circuit.
release
for
action
situation,.
(9th C i r .
were
1975)).
Ninth
10,293
continue
City
Cir.
Jhe
Cumulative
have
(citing
would
754,. 759-60
sales
NIH
not
v.
but
other
would
direct
Consider
753
Ida.
for
to
Peterson,
justified
forest)
3,
Thomas
In T h o m a s ,
the
May
member).
qf,
sales),
the
of
committee
1985).
(timber
."Thomas t o
Minutes
(1985);
Cir.
Analogizing
of
Committee,
S. Gottesman,
national
40
held
of
through
consideration
publication
ADvisory
(statement
C.F.R.
one a c t i o n
place.
8
DNA
for
it
to
would
formulating
proposals.
213.
(1976)
Kleppe
v.
(programmatic
program).
type of
See
The
program
in S c i e n t i s t s '
EIS
granting
that
Inst.
Sierra
of
the
for
Club,
is not
required
permits
District
Public
427
for
of
U.S.
in
rDNA
absence
technology
Columbia
Information
390,
Circuit
v.
AEC,
of
400-02
concrete
is not
the
referred
481
to
F.2d
SO
1 0
79
(D.C.
Cir.
development
fast
1973),
program
breeder
experiments
involving
reactors.
in
rDNA
Implementation
of
Research;
NEPA,
National
Request
Environmental
liquid
therefore
has
no
Regulations
for
Comments
on
Statement,
(1985).
Health,
Environmental
50
Recombinant
Assessment
Need
for
Fed.
release
made
s 1502.4(c)(3)
of
and
metal
for direct
See CEQ Final
Institutes
for
Impact
and
a research
of
has no program
to it.
of
to
the construction
40 C.F.R.
Availability
Comment,
pertained
technology,
commitments
See
ich
NIH
irretrievable
214.
w h
a
for
DNA
Public
Programmatic
Reg.
14,794,
14,795
(1985).
215.
See
California
756 F.2d
at
143
216.
Brief
62-63,
(D.C.
Request
Environmental
Regents
Foundation
Institutes
the
on E c o n o m i c
of
of
Health,
Environmental
for/' C o m m e n t s
Impact
of
University
Trends v.
of
Heckler,
1985).
Availability
Comment;
the
Cir.
National
Research;
of
on
Statement,
Assessment
Need
50
Recombinant
for
Fed.
a
Reg.
for
DNA
Public
Programmatic
14,794,
14,795
(1985).
217.
Oct.
See
29,
Recombinant
1984
Meeting
DNA
Advisory
Committee,
at 8
(statement
Minutes
of R . C l o w e s ,
of
committee
member).
218.
NIH
was
with
the
Health,
In
able
the EA
on
to cite
genetically
the University
to specific
engineered
Environmental
of C a l i f o r n i a
tests that had been
bacteria.
Assessment
00210
experiment,
and
National
Finding
conducted
Institutes
of N o
of
Significant
5
Impact
22-28
(1985)
Nickolas Panopoulos,
also discussed
Id.
at
Motion
environmental
Memorandum
for
Economic
worst
on
whether
the
federal
s
an
Cthat
it
a
was] was
Yost,
EA
site.
Garrett
General
be
Case
The
requiring
1985).
Trends
The
court
did
not
mention
Andrus
v.
Sierra
required.
see
(CED r e g u l a t i o n s
40 C.F.R.
i.n
on
required
to be
relevant
to the decision
Analysis
are binding
be
experiment
"information
. . . ."
on
1985).
on Economic
at 841, but
release
lacked
& W. Covington
Counsel
was
for
drafted.
regulation,
CEQ
Mr.
that
improbable,
but
of
alsg
Our
Ecosystems
Save'
i s s u e of
case analysis would
important
Worst
the
(1985);
(1979)
direct
known
Cir.
(D.D.C.
of
Foundation
(D.C.
in F o u n d a t i o n
id.,
in S u p p o r t
if
conducted
to
adverse
and t h e m e a n s
s 1502.22
Natural.
to
(1985).
Resource
i n P r o c e e d i n g s _ g f _ a _ S y m p g s i u.m„gn_Worst_.Case_Qnil.ysi s
(L.
if"
1502.22
EIS that
143
829, 836
A worst
[were] not
regulation
in an E A
347, 357
19-20,
also raised
analysis' would
permitted
!i§Di*gemer]t,
"what
&
The
experiment
Authorities
at
756 F.2d
inadequate,
case
U.S.
221.
62, 62
was
C.F.R.
issuing
obtain
Lindow
Berkeley).
at the
and
Injunction
F. Supp.
agencies).
NIH
impacts
was
EA
40
442
after
610
a worst
220.
the
Steven
California,
Points
Trends
analysis
v. W e i n b e r g e r ,
Club,
of
Drs.
conditions
v. Heckler,
Economic
case
that
of
Preliminary
Trends
Foundation
held
University
by
34-39.
219.
a
(application
severe
eds.
when
Yost
1985).
the
worst
described
is,
"what
consequences,
v. Clark,
Nicholas
if
case
impact,
were to occur"?
747 F.2d
analysis
the regulation
an
1240,
Yost
as
a
perhaps
Id..;
1245 n.6
see
(9tn
103
Cir.
1984)
(1:10,000
relevant
to
informed
F.2d
974
(5th
by
957,
its
Asked
Act
worst
case
1983)
Council
Concerning
Regulations,
46
analysis
of
decisionmaing);
Cir.
remoteness);
Questions
possibility
18,026,
"low
event
is
v. sigler,
695
case analysis
National
Reg.
includes
Club
Environmental
CEQ's
Fed.
Sierra
(worst
on
catastrophic
is not
Quality,
barred
Forty
Environmental
18,032
(1981)
Most
Policy
(scope
probabi1ity/catastrophic
of
impact
event") .
222.
Cir.
Village
1984)
Sprays,
v.
Bear,
3, 4
is General
(application
University
case
of
analyses
since
at
organisms
when
Recombinant
of
DNA
Management
Against
(9th C i r .
Toxic
1983)).
8< W . C o v i n g t o n
Institutes
of
No
Steven
to FDA
Worst......Case
1985).
Health,
Significant
Lindow
for
&
Ms.
Bear
review
for
Products
Bull.
Budget,
would
approval
of
be
(1985)
Panopoulos,
17
of
See
engineered
the
(1981);
The Regulation
of
in
Chemicals
8<
the
lechnglggy,'
see... a l s o
New
same
Goldberg
Admi.ni s t r a t i g n
DNA
worst
products
under
approval.
Recombinant
15,
46
genetically
thus
and_„Drug
gf
Impact
Nickolas
premarket
premarket
Food
Environmental
The FDA has required
Manufacturers
applying
Technical
of
Berkeley).
filed
1981.
and
eds.
on
CEQ.
I h e _ . R g l e . _ o f ..the
R e g u l atio.n
of
of
EA's
subject
requirement
Mi 11 e r ,
Garrett
California,
least
1480-81
(9th
S y m p o s i urn
Drs.
in
1475,
Prgceedings_ofa
Finding
by
F.2d
Citizens
616
in
(L.
and
Oregon
605,
The..Federal__ R e g u l a t i o n _.(4_0
National
Assessment
720
v. Clark, 733 F.2d
W o r s t _.Case_Anal ysi s:
Counsel
224.
Pass
Southern
Clark,
Cjs.Fjs.Rjj. 1 . 5 0 2 . 2 2 ) . ,
AnaLysis
False
(citing
Inc.
223.
of
4
Office
Under
the Tox
Substances
Control
Act
Risk—Assessment—Hearings,
case a s s u m p t i o n s
notice review
225.
Proposed
Reg.
See
Council
Information
Worst
Letter
to A. Alan
Stafford,
49 F e d .
226.
ordering
Notice
for C o m m e n t s ,
48
have
4803
on
based
spraying
by
on
the
on
Proposed
32,234,
32,236
Envtl.
amendment
8<
M.
Seea
and
Act").
10,396
unwise");
Randolph,
22,
1984)
effectiveness
The
Quality,
I^Jpjfiorandum f o r F e d e r a l
the
or
Don'_t
10,394,
(Feb.
substantially
the
evidence,
e._g. , Y o s t ,
"illegal
Baucus
Policy
Fed.
hypothetical
L. Rep.
as
Environmental
proposal
was
Notice—Withdrawal
Agency NEPA
Liaisons,
(1984).
of
can be analogized
Land
the
Management
would
cause
1240,
cancer.
Amendment
(1985).
to prepare
a
to 40
cancer.
1245-46
evidence existed
cause
to the Ninth
Circuit
worst
hypothesis that herbicides proposed
Bureau
scientific
Quality,
purely
opposed.
13
Ecosystems v . Clark, 747 F.2d
would
are
o-f
by the CEQ to base
"credible scientific
that
"weakened
situation
the Bureau
herbicides
A proposal
Durenberger
Guidance
analysis
credible
and Request
(1983).
Environmental
This
premanuf acture
Quality,
Environmental
in
worst
on
regulation
Council
Reg.
during
H i l l , Chairman, CEQ, from Senators
would
of P r o p o s e d
(EPA u s e s
Act).
proposed
D.
of t h e N a t i o n a l
reprinted
Substances Control
Analysis,
(describing
withdrawn.
-findings
id.., w a s h e a t e d l y
(1983)
(amendment
risk
consequences
Case
15, 1984) 5 ,
supra note 94, at 349
Guidance
36,48-
than
conjectural,"
R.
Toxic
case analysis
rather
Gut
under
36,486,
worst
in m a k i n g
(Mar.
showing
See
CFR
<9th C i r .
that
Council
1502.22,
Likewise, no scientific
mm
See
Save
case
for
Our
1984).
No
a n y d o s e of
the
on
50
Environmental
Fed.
evidence
Reg.
existed
st*
to p r o v e
that
technology,
the
however,
the h e r b i c i d e s
Woe s t
C.a s e .
10,271
herbicides
was
Thomas,
228.
Discussions
supra
14
Subcomm.
of
on
on
Science
of
effects
Update:
Envtl .
rDNA
The
L. Rep.
of
NEPA
10,267,
(Comm.
Print
Once
"catastrophic
and
worst
proposal
for
Jersey,
suggested
case
siting
l a b o r a t o r y , in
and
Report
Prepared
Technology
Research
of
of
for
the
Policy
House
Research
Service, 94th
Genetics, and Cell
scenario
that
in
A
Cong.,
2d
Biology
toxic
Township
gases
scenario
scenario.
of
drifting
was unable
for
occur
tends to
occur.
36
described
outweigh
example,
liquid
a
New
h y d r o g e n 'on
the
of
the
siting
a worst case
scenario
tank, resulting
in an
tdxic
the
laboratory,
neighboring
residences.
into
conceived
worst
For
public
in M o r r i s T o w n s h i p ,
opponents
to persuade
it had
The
outlined,
1 5 0 0 g a l l o n s of
consultant
rupture
been
it will
laboratory
in t h e h y d r o g e n
the
credible
storing
has
it could
that
a research
Morris
a leak
laboratory
possible
inevitably
e p i d e m i c s or t h e c r e a t i o n
by the Science
Human
t h e prqjraoility
roof.
in
Technology
possibility
on
resulting
rDNA technology
organisms."
Congressional
emphasis
resulting
harmful
Engineering,
emphasis on the
involving
t h e r i s k s of
1976).
a
laboratory
326.
Science, Research
the
Sess., Genetic
n o t e 7 2 , at
of
uncontrollable
Division
worst
on t h e h e a l t h
See Comment,
A n a 1 y s i s... R e g u 1 a t i o n ,
227.
Comm.
The
evidence
Unlike
(1984).
and
the
medical
not cause cancer-
conflicting.
becomes discussions
new
did
gas
in
the opponents
in
passible
lieu
of
scenario
explosion,
to accept
the
became
a
worst
the
105
standard
for
community.
Si t i n g :
judging
See
the
risk
of
siting
the
A p p e n d i x _ C , _ E n y ironmental..Concerns
Ihe_..Mgrri.s „ _ T o w n s h i p - B e l . l c o r e
Office
o-f
Sci.enc.es
Technology
Assessment,
A._XSGbD.ica.l._Memgrandum
Wildlife
laboraory
in
Laboratory
Congressi onal
5s
(1986);
Hearing
the
Sybcomm.
on_Fisheries„and
for
see also Fish
on
and
Council
E n y i r g n . m e n t a i _ . Q u a l i t y _ R e a u t h p r iz a t i on... a n d . O v e r s i g h t - - H . R .
Before
the
The...Regulatgry_Enyirpnment
136-39
Miscellaneous-—Part
Case,
and
in
of
4.585,
Wildlife. Conservation
and
%
the_Enyirgnment_of
Fisheries,
9Bth
CEQ__Hearing3
frequently
aspect
Sess.
56
(statement
of
Rep.
Breaux)
See
229 S c i e n c e
analysis
plants
by
the
central
the
media).
950,
950
feature
Yost, supra
method
for
communities,
and
hazardous
Olscussi on--The
considering
housing
waste
Weaknesses
Wgrst_Case_Analysis
1985)
(statement
(worst
case
consequences
231.
regulation
of
thereinafter
(worst
of
The
to
101,
sites
the
only
Industry,
has
require
(worst
e f f e c t s of n u c l e a r
in
on
case
power
earthquake
f1oodplains);
Pagel
a n d _ S t r e n g t h s _ g f _ W o r s t ._Case_An„aIysi.s
103
in
(L.
encourages
introducing
CEQ
as
analysis
and
10,396
developments
Prgceedings_gf_a_.Sy_mpg.sium
Garrett
L. Silver, Sierra
analysis
of
and
cited
case
a project,
note 225, at
iD_the_Managemeot_pecisign_Prgcess,
on
(1984)
Marine_
(1985).
. See3,_ei.9i,
near
Merchant
S u n , Bi_gtechnglggy...Movie:_Debut_._.Wgrries
is best
faults,
on
2d
becomes
229.
House.....Comm.
Cong.,
reported
230.
the
Club
Legal
candor
"all
the
known
00215
Defense
concerning
to>:ic s u b s t a n c e s
interpreted
& W. Covington
into
worst
ggssible
eds.
Fund)
potential
environment).
case
analysis
environmental
51
consequences
Quality,
of
agency
Forty
Most
Asked
Environmental
Policy
18,032
(emphasis
(1981)
Courts
Supreme
Court
entitled
U.S.
Act
not
n. 77
(1979).
682
(D.C.
deference
to
CEQ's
Sigler,
695
F.2d
(under
original
follow
CEQ's
46
Reg.
Fed.
CEQ's
"CEQ's
National
18,026,
Peak
1984)
Grizzly
NEPA
is
Andrus v. Sierra
Club,
442
Bears
1982)
"Forty
Questions");
regulation)
v. NRC, 751
should
F.?d
Cabinet
to
accord
see_.al s o
1983)
be based
1287,
Mountains
v. Peterson,
(declining
(5th C i r .
The
of
(citing
Cir.
976
interpretation.
interpretation
deference."
Cir.
957,
Environmental
Concerning
B u t .see D e u k m e j i a n
(D.C.
on
original).
that
Wilderness/Scotchman's
678,
Regulations,
substantial
358
Council
Questions
always
stated
to
347,
1302
do
action."
685
F.2d
substantial
Sierra
Club
v.
(worst c ^ s e
analysis
on
rule
NEPA's
of
reason).
232.
The
regulation
NEPA.
CFR
to
CEQ
conform
Council
1502.22,
Resources
50
Fed.
Inc.
1982)
("CuJnder
only
the worst
reason
Quality,
Council,
consider
(1983);
Environmental
of
Defense
must
v.
to. t n e r u l e
32,234,
Cir.
Co.
on
amending
Reg.
(D.C.
impacts"),
has proposed
Proposed
32,238
Rule
'reasonably
of
Iowa
Citizens
487
F. 2d
849,
the
light
of
Engineers,
of
1092
for
1973)
Environmental
F.2d
1123,
Cf._
1131
00216
an
Fund,
40
n.89
agency
environmental
Gas
Inc.
"must
(5th C i r .
476
&
Elec.
Inc., 462 U.S.
Quality,
Defense
to
Natural
459,
Baltimore
Council,
(NEPA
interpret
Reason,
foreseeable'
Environmental
(8th C i r .
reason");
492
Defense
analysis
Amendment
v. NRC, 685 F.2d
NEPA's
Resources
to
(1985).
rey!d_gn_g£her_grgynds_syb_ngm.^
Natural
used
case
v.
87
Volpe,
be construed
Inc.
1974)
v.
("[wile
in
Corps
must
interpret
the
requirements
of
NEPA
according
to
a
-rule
of
r e a s o n ' ") .
One
commentator
analysis regulation
involving
has
changed
scientific
and
.the
60
Wash.
L.
proposed
amendment,
however,
to
traditional
soft
selective
the original
deference
in
including
supported
areas
Amending
CEQls
Decisionmaking,
233.
in
See
DNA T e c h n i c a l
234.
of
look
National
E n v i r o n m e n t a l _ Pol.icy
Rev.
would
standard.
scientific
Worst
Case.
101,
112
in
146-47
because
look
agencies
uncertainty.
Analysis
See
Rule.:
L. Rep.
10,275,
Sharpies,
Spread
of
remote
43, 55
be
credibly
Rosenbaum,
Better
(1985).
Organisms
with
6
Novel.
Recombinant
(1983).
(L.
Garrett
former
General
worst
on
whether
to
756
F.2d
& W. Covington
Counsel,
CEQ)
case analysis
discussions
eds.
1985)
(outlining
regulation
of
usefulness
locate potentially
at
Case
gf_a_Sympgsium_gn„Wgrst_Case_A^
areas).
235.
standard
Towards
10,277
'The
could
evidence they believed
15 E n v t l .
Prgceedings
commenting
deciding
Note,
(1984).
reverse the hard
glance
scientific
Bull.
took p l a c e w h e n
and
decisions
S e e _ P a n e l _Di s c u s s i o n - - F u t u r e ^
Analysis,
N. Y o s t ,
case
to a hard
§§ngtypes£_Jhgughts__from_an_.EcologicaI_Perspective,
132,
worst
C o u n c I I ..90..... E n v i r o n s
Section._1502._22,
the
that
the court's
uncertainty
S c i e n t i f ic ..Uncertainty
Actrzl.be
argued
160.
00217
hazardous
(statement
discussions
was
of
that
formulated,
of r e g u l a t i o n
activities
in
in
236.
Science
174,
See
1321,
at
approval
1321
5-6
237.
(1985);
in
of
see.also
Win
Advisory
Monsanto's
possibility
in.Court .Ruling,
Role,
decision
of h a v i n g
supra
note
not to seek
experiment's
Biotechnology
and
Bulkley,
NIH
proposal
Regul ati o n i
Hearing
.Before
on... O v e r s i g h t _ a n d _ I n v e s t i g a t i o n s of ...the H o u s e C o m m .
[hereinafter
227
court).
See
Subcgmm.
R i f k i n _._and_..NI.H
(describing
because
challenged
Energy
Sun,
Commerce,
cited
Deputy
98th
Cong.,
2d
Sess.
as Biotechnology.. .Hearing]
Director,
Office
of
90-91
(statement
Science
and
... t. h e
on
(1984)
of
B.
Technology
Pol i c y ) .
238.
See
United
International
Impact
on
(1984).
States
Developments
Certain
In
Sectors
1933,
biotechnology
in
of
for, the
growth
potential
DNA
a
t w o p i e c e s of
together
of
and Their
Chemical
billion
was
Possible
Industry
ix
invested
in
States.
Id.;
the
DNA spliced
Health,
Reg.
also
Alexander.
4 , 1 9 8 5 , at 5 6
(describing
firms).
NIH
inside
Guidelines
cover
technology
outside living cells, but
living
cells.
Recombinant
696, 697
see
DNA
See
Advisory
Framework
5(5,856, 5 0 , 8 5 7
Committee;
984) .
of t h e W o r k i n g
Group
for Regulation
(1984).
not
National
O f f i c e of Science and Technology Policy, Proposal
Coordinated
Reg.
$2.5
of b i o t e c h n o l o g y
example,
Meeting, 49 Fed.
240-
U.S.
Gene Green, Time, Nov.
For
spliced
Institutes
the
Commission,
i
Going
involving
Trade
Biotechnology
about
n the United
239-
International
of B i o t e c h n o l o g y ,
It h a s b e e n
on Biotgch^ojocfy
suggested
49
for
Fed,
that
creation
was spurred by the
reaction
of
an
official
perceived
damage
regulation
Policy
in
of
of
to
Office
of
on O S T P
and
for
26 n J
and
Budget
companies by EPA's
Comments
Proposal
Biotechnology
Biotechnology.
Management
biotechnology
biotechnology.
Institute
Regulation
the
of
the
15,
proposed
Environmental
a Coordinated
(Apr.
to
Framework
for
1 9 8 5 ) , r e p r i n t e d , in
. A g r i c u l t u r e , H e a r i n g s ....Before ..the s.ubcomm,._...on
1 0 v e s t i. g a t i o n s... a n d . O v e r s i g h t _ of... t h e... H o u s e C o m m . ... o n _. S c i e n c e
Jechnglogy,
99th
Cherei naf ter
see_.„al.sg
1984) ,
366
ci t e d
Office
Chemicals
Under
of
Management
the Toxic
("Innovation,
in
regulatory
effects
making."
Reg.
242.
Id,,
50,858
at
1970's
biotechnology.
229
n.*
(1985)
Act
23
firms,
is the
industry.
careful
New
(Mar.
supra
small
of
15,
note 94,
is
not
merely
Erecting
consideration
of
the progress that the U.S.
at
new
their
. . .
is
original)).
49 Fed.
the
at
without
jeopardize
(emphasis
Control
Risk_Assessment..Hearings,
industry—it
barriers
204,
a n d _.Agri c u l ture..... H e a r i n g s ! ;
Substances
241.
during
Sess.
and B u d g e t , The R e g u l a t i o n
particularly
this
could
1st
a s B i gt.echngl.ggy
regrinted__..in
important
DNA
Cong.,
.and
on
50,856
50,905.
whether
See, e-g^,
Techniques,.
S<
(1984).
new
Congress
held
laws were needed
to
hearings
regulate
Industrial.„Appl icatigns_of..Recgmbinant
Hearing
Before
on
Sci e n c e t
I e c h o g I g g y j L . _ a o d . _ . S p a c e _ g f _.the_Senate^^^ Comm... g n . _ C g « n m e r c e J
Science^.
and_Transggrtat ion, 96th
C o n g . , 2d
8esearch_Hgari.ngs,
note
Many
95th
bills
Cong.,
supra
were
1st
Sess.
Subcomm,.
(1980);
R e c o m b i n a n t ...DNA
16.
introduced,
Sess.
the
but none passed.
(1977);
00219
S. 621, 95th
E.g., S.
Cong.,
1st
1217,
Sess.
60
(1977);
H.R.
4759,
95th
Cong.,
1st. S e s s .
Talbot,
I n t r o d u c t i o n ,_to ...Recombinant,. .DNA R e s e a r c h , D e v e 1 o p m e n t. and.
E y o l u t i g n _ o f _ t h e _ . N I H „ B u i del. i nes.,
Tol -
L. Rev.
When
it
risks were not
regulating
reprinted
of
Health,
Jacob
Jr.
National
Revised
Proposed
(describing
apparent
technology
Williams,
in
(1981)
materialising,
Kennedy,
Harrison
Research
became
rDNA
Jr., Secretary
Edward
804, 810
.and
pressure
Education
Javits, Gaylord
Richard
Institutes
Guidelines,
(1978).
00220
proposed
43
-for
a
See Letter
and
Fed.
the
hypothetical
specifically
to Joseph
Welfare
Reg.
Califano,
from
Nelson, Adlai
Health,
12
legislation).
law
Schwei ker
of
S e e .general ly
L e g i si a t i o n ,
to Congress that
eased.
8<
(1977).
(June
Senators
Stevenson,
1,
1978),
Recombinant
60,103,
DNA
60,104
the
243.
49
Fed.
244.
Id..
Federal
(EPA);
id..
Reg.
The
agencies
Register.
at
50,897
at
50,905.
246.
Id.
at
50,863.
247.
Id...
The
expertise
would
of
be
the
BSB
RAC,
ten
NSF
to house
(a
compromise),
Health,
Recombinant
Biotechnology
of
W.
249.
See
Culliton,
250.
See
Miller,
6651
198,
198
Engineering
(1982).
(FDA);
frameworks
id.,
at
in
50,880
or
former
BSD.
the
BSB
by the present
the
larger
was
developed.
from
experience
and
members
of
RAC
New._Biotech
would
have
created
RAC's
staff.
After
committee, • the
of
the
(1985).
National
Committee,
Minutes
two
See Culliton,
736, 737
the
including
Institutes
at
NIH
published
Working
Meeting
a
10
of
Group
on
(Mar.
1,
Gartland).
49
Science,
Fed.
policy
utilize
Advisory
248.
News
for
Coordination,
(statement
Sci.
s
I)KfA
the
Science
proposal
scheme
1985)
229
of
administered
declined
at 5 0 , 8 7 8
To
present
members
Reyi_ew_Board_Planned,
The original
their
was to have 25 members
committee.
initial
"super—RAC,"
published
(USDA).
Id.
interagency
50,858.
See...id.,
245.
each
and
at
Reg.
at
50,863.
supra
note
247,
at
737.
G e n e _ S p l i c i ngL.J_F.inal L _ F e d e r a l .
(1985).
and
The Federal
Technology
Coordinating
is authorized
by
Plan,
128
Council
for
42
U.S.C.
251.
See
Coordinated
Office
Framework
Establishment
Committee,
of
50
for
of
the
Fed.
Reg.
253.
Charter
of
of
Federal
Engineering,
and
charter
be
will
254.
Framework
Science
47,176
Id...
256.
Idi
257.
See
Comment;
After
Coordinating
(19S5).
Science
two
Coordinating
Council
years,
for
Science,
renewal
of
the
Id.
and Technology
of B i o t e c h n o l o g y ;
Coordinating
Policy,
Coordinated
Establishment
Committee,
50
of
the
Fed.
Reg.
(1985).
255.
Research;
47,175
Policy,
Biotechnology;
Science
Coordinating
Science
Regulation
Biotechnology
47,174,
reviewed.
of
of
Biotechnology
Technology.
Office
for
the
Technology
Regulation
47,174,
Id..
the
and
Biotechnology
252.
Committee
Science
National
Institutes
Availability
Request
Environmental
of
for
Health,
Environmental
Comments
Impact
of
Statement,
on
50
Recombinant
Assessment
Need
for
Fed.
a
Reg.
for
DNA
Public
Programmatic
14,794,
14,795
(1985).
258.
and
See
Office
scheduled
Sun,
of
to
policies
by
policies
may
supra
Safety
publish
January
clarify
n o t e . . 1-75, a t
and
Health
revised
31,
the
1986.
The FDA,
Administration
versions
50 Fed.
jurisdiction
mm
1016.
for
Reg.
their
EPA,
(OSHA)
USDA,
are
regulatory
at 47,174.
These
issue.
&
To
date
OSHA,
OSHA
adopting
regulations
a
Safety
an B i o t e c h n o l o g y ,
probably
agency
must
standards
Act,
29
show
are
material
authority
259.
Cin.
regulate
exists
Safety
284
(1981)
safety
Health
Textile
Mfrs.
(1981)
(quoting
Inst.,
"'significant
of.
the
and
Petroleum
Appli cat ions
which
before
490, 514 n.2
find
approach
under
. S e e ......gener a l l y
L. Rev.
rDNA
authority,
v. American
Guidelines
OSHA's
see_.alsg A m e r i c a n
(OSHA must
4'48
risks
'
of
Korwek,
OSHA
R e c o m b i n a n t_
DNA
(reviewing
OSHA's
technology).
Environmental
Certain
Microbial
Protection
Products,
Agency, Proposed
49
Fed.
Reg.
Policy
50,880,
(1984).
260.
Biotechnology
(statement
of
Technology
Pol icy).
261.
at
ALO-CIO
issuing
hazards.
Agency
(1985).
risk
452 U.S.
impairment").
U.
deferred
See Occupational
l o d u s t r i al
See
Regarding
850,882
50
to
its statutory
(1980)
Of
lechnglogy,
14,468
(1982);
regulati
biotechnology's
a significant
Dep't,
health
approach,
Administration,
Reg.
Donovan,
642
Regy1atign
of
s 655(B)
Union
biotechnology
of
Health
Fed.
that
v.
607,
and
promulgated.
Inc.
Industrial
issued
evidence
result
U.S.C.
Inst.,
U.S.
a
50
not
wait-and-see
pending
Occupational
is
has
See
B.
Hearing,
Bulkley,
Deputy
Environmental
supra
note
Director, Office
Implications
237,
of
at
Science
Report,
supra
Department
to G.
note
93
and
202,
42.
262.
Letter
Director
and
9yoted_in
Comments
from
Science
of
W. Walsh,
Advisor
the
State
to the President
Environmental
Policy
Keyworth,
(May 2 7 ,
Institute
on
1983),
OSTP
proposal
for
a
Biotechnology,
263.
a
Office
50,856,
264.
Regulation
265.
for
OSTP's
at
and
2-8,
3 C.F.R.
supra
Technology
Comments
s
of
Policy, Proposal
of B i o t e c h n o l o g y ,
for
49
Fed.
note
the
a
Coordinated
supra
OMB's
Environmental ' Policy
note
role
Framework
240,
at
3.
for
For
a
in f e d e r a l
biotechnology
management
decisions
25-27.
127
and
of
for
Biotechnology,
id..
Regulation
n.*.
Regulation
Proposal
reviewed
Hearings,
and
for
(1984).
OSTP
of
see
are
Science
50,856
of
criticism
policy,
of
Framework
on
Framework
n o t e 2 4 0 , at 26
S e e . . g e n e r a l l y
Institute
EPA
supra
Coordinated
Reg.
Coordinated
(1982).
Risk
criticized
94,
at
297
by 0MB.
(EPA
See
by
Risk.Assessment
response
to
committee
questions).
266.
As
management
mentioned
prmit
decisionmaking.
Science
and
the Science
21,596-97
science
(1984)
policy,
267.
See
Biotechnology:
Clarification
Agriculture"s
26B.
,the
See
intrusion
supra
Technology
and
earlier,
notes
(risk
United
when
Agriculture's
Regulatory
Recombinant
90-109;
see
(Mar.
process
is blend
rxegulatory
risk
judgments
in
also Office
of
Review
Reg.
of
of
21,594,
science
uncertainties
General
1986)
and
Carcinogens,
scientific
States
50
value
Principles, 49 Fed.
assessment
especially
assessments
of
Policy, Chemical
its Associated
36,
risk
and
exist).
Accounting
Office,
System
Needs
thereinafter
cited
as
System].
DNA Advisory Committee, Minutes
of
S e
P*6 J
23,
1985
Meeting
15
(statement
269.
IcL
at
16.
270.
Id..
at
17.
271.
Id..
272.
Id...
273.
Id_._
at
18.
274.
S e e ..supra n o t e s 9 0 - 1 0 9
275.
Recombinant
Biotechnology
10
at
FDA
of
those
Register.
See_.i.d._
Biotechnology
276.
See
accompanying
text.
M i n u t e s of
Mar.
1, 1985
The EPA announces
'»involving
at
11
reviews
proprietary
(statement
of
data,
on
at
(describing
of
in
Group
Meeting
W . Gartland, Executive Secretary}'
reviews).
including
and
OSTP).
Advisory Committee, Working
Coordination,
(statement
EPA and
DNA
of B . H e a l y ,
proposals,
the
A. Goldhammer,
Federal
Industrial
Association).
id..
at
11
(statement
of R . C l o w e s ,
committee
member).
277.
3,
1985
See
Recombinant
Meeting
at
26
DNA
Advisory
(statement
Committee,
of
Minutes
R. Mitchell,
of
May
committee
member).
278.
Framework
Office
for
of
Science
Regulation
Biotechnology
Science
47,174,: 4 7 , 1 7 4
(1985).
00PS5
and
Technology
of B i o t e c h n o l o g y ;
Coordinating
Policy,
Coordinated
Establishment
Committee,
50
Fed.
of
the
Reg.
^
279.
See
B i o t e g h n g l o g y ...Hearing, s u B r a
(statement
o-f
D.
Behavioral,
and
Social
280.
Science
See
1296,
281.
72
Director,
102-03
Biological,
B i o t e c h . P o l i.cy... D r a w s ._ F l g g d _ g i _ C o m m e n £ s ,
228
(1985).
Study...of...Sci.entific....Base....for
Shelved„After...Criticism,
9 Chem.
R e g u l ation...... of
Reg.
Rep.
RDNA
(BNA)
72,
(1985).
282.
50
283.
B i g t e c h o g l g g y _ H e a r i n g , supra note 2 3 7 , at 95
o-f R e p .
See
Guidelines
Fed.
for
Reg.
See
Regulations,
50,897,
at
Molecules
National
50,905.
Research
Institutes
Involving
Department
(statement
(1984)
Guidelines
(Oct.
286.
NIH
Molecules,
287.
See
Agriculture,
(citing
Molecules,
Statement
of
48
Policy
and Products, 49 F e d .
Memorandum
Research
to Heads
! o v o i vj i;g
Institutes
for
Reg.
of
Research
Health,
of
for
Reg.
Department
Recombinant
E.
24,548, 24,549
Education,
Kendrick,
United
Acting
States
Notices
Involving
EnyirgomentaI_ImpiicationsHe
of
DNA
NIH
DNA
1979)).
National
48 Fed.
Health, Notices Under
Recombinant
Processes
for
Guidelines
(statement
and
15,
of
(1983).
of
Biotechnology
50,989
Agencies,
Science
Reg.
24,548, 24,549
285.
Under
Fed.
Sikorski).
284.
142
1296
Assistant
at
Sciences Division, NSF) .
Sun,
See
Products
Kingsbury,
note 237,
Actions
Recombinant
DNA
(1983).
}
supra
Deputy
Department
m&6
on
of
note
200,
Secretary
at
for
Agriculture).
288.
Department
Regulations,
50,897,
of
Biotechnology
50,903
(1984).
Agriculture
Recombinant
coordinated
USDA's
to be
superseded
to
System,
note
supra
290.
Id..
291.
See
and
Products,
by
since
Committee
See
on
Policy
49 Fed.
the
which
1976,
is
has
expected
Biotechnology
Agriculture's
for
Reg.
committee,
Committee,
policy
in U S D A .
of
advisory
Research
the
26
and
USDA's
DNA
at
ss
ss
42
Processes
The
based
267,
7 U.S.C.
Legal.
1986
be
289.
Statement
biotechnology
in
Agriculture,
Agriculture,
in
Regulatory
8< n . 4 .
150aa-150jj
(1982).
2801-2812.
U.S.C.
Regulatory
s 264
(1982).
Issues_.i.n_BigtechDology,
Rlsk_8<_Regulati on
§Qd._the_Enyi.rgnment;
See_.general.l.y
137,
149
in
McGarity,
Bigtechnglogy
(1985).
\
292.
under
7 U.S.C.
the
movement
States
Plant
of
and
5
150bb(a)
Quarantine
genetically
between
293.
Id..
294.
49
295.
I d g.
296.
Id..
297-
Id;.;
Assessment
(application
s
of
Act,
engineered
USDA
id.,
ss
also
has
151-167,
organisms
authority
to
into
the
regulate
United
states.
150aa(c).
Fed.
and
(1982).
Reg.
see
at
National
Finding
Drs.
of
50,902.
Institutes
No
Steven
of
Health,
Significant.
Lindow
00^7
&
Environmental
Impact
Nickolas
25
(1985)
Panopoulos,
&
University
strains
of
of
nucleating
the
University
Health,
24,549
s
bacteria
only
of
In
the
The USDA reviewed
experiment.
on
Under
Actions
of
DNA
and
National
NIH
48
their
Fed.
ice
California
to area
crops
approved
the
Institutes
Guidelines
Molecules,
negative
than
that, w e r e not. p a t h o g e n i c
Id..
Recombinant
nucleating
University
California
for
of
Research
Reg.
24,548,
(1983).
298.
49 Fed.
299.
7 U.S.C.
300.
See
301.
Id.
147a
Reg.
s
at
50,902.
150dd(b)
49 Fed.
Reg„
(citing
(1982).
at
Organic
50,902-03.
A c t of
Sept.
2,
1944,
S<
Adler,
7
U.S.C.
(1982)).
302.
Released
Envtl.
Ice
are no more pathogenic
strains
introduced.
Notices
Involving
Berkeley).
counterparts.
experiment,
were to be
California,
See
from
g e n e r a l l.y
the L^J:
L. Rep.
The Environmental
10,366,
303.
7 U.S.C.
s
304.
,7 U . S . C .
305.
49 Fed.
306.
7 U.S.C.
307.
Id.
s
2805.
308.
Id...
s
2803.
McChesney
10,376-77
150aa(c)
Reg.
at
(1983).
(1982).
50,90£.
s 2803(a)
Regulatgry_Framewgrk,
(1982).
ss 2801-2812
(1982).
Biotechnology
13
309.
Environmental
310.
See
Implications
Report, supra
note
159,
at
37.
Letter
J. Peach,
Director,
Division,
United
reprinted
267, at
67,
Community
General
Secretary,
and E c o n o m i c
Accounting
i_n A g r i c u l t u r e ' s R e g u l a t o r y
USDA,
to
Development
Office
(Feb.
4,
System,
supra
note
Criticized
and
69.
See
Defended,
Resources,
States
1986),
311.
-from J . N o r t o n , A c t i n g
232
Sun,
USDA
Science
Biotechnology
316, 316
~*:12.
Agri cul t u r e ' s
313.
Id.,
at
314.
Id...
at\ 3 4 .
315.
Id.,
at
60.
316.
IcL
at
44s
317.
Id.,
at 47;
Review
(1986).
Regulatory
System,
supra
note 267,
at
57.
Reviews
Reg.
USDA
Rep.
and
318.
Toxic
When
EPA^
57, 57
EPA
42-43.
Substances
White..House_Plan_CalLs_for
Agriculture
(1986)
as reason
Minutes
see_also
for
of
(referring
delay
Public
Advisory
to
Adyi.sgry_Role,
supra
320.
49 Fed.
at
turf
Meeting
of
note
the EPA
(Nov.
1 7 4 , at
10
disputes
of b i o t e c h n o l o g y
Committee at 9
319.
Reg.
Jurisdictions_Over 1 ap,
Joint
Chem.
between
regulations).
Administrator's
16,
1982).
5.
50,884-855.
«0SB>9
70
321.
Id.
at
50,887.
322.
Id..
at
50,888.
mechanisms
in
Management
and
portion
of
Structure
EPA may decide not to
its regulations.
Budget,
its
After
criticism
EPA was stated
biotechnology
for
Bi.otechnol_ogy
See
Advisory
to
be
policy.
include
by the Office
wavering
See
Proposed,
227
these
Sun,
on
of
this
Regulatory
Science
274,
274
(1985).
323.
announced
formation
See 50 F ed.
324.
Reg.
See
of
Role, supra
its scientific
at
Recombinant
DNA
Coordination,
at
of
(statement
325.
See
200, at 48
id..
at
advisory
Advisory
M i n u t e s of M a r .
Environmental
of
G.
Karny,
Program,,Office
of
Senior
Technology
(statement
of
A.
Microbiology,
University
of
Illinois
problems
question)
of
326.
("NIH
accidental
See
of
Rep.
compliance
with
Dingell)
of
at
7 U.S.C.
328.
15 U . S . C .
yet.
Working
Group
ss
1985
Analyst,
note
Biological
Assessment).
But_see
Professor
Chicago)
supra
of
(answer
address
note
(EF>A i s s p e c i f i c a l l y
ss 2601-2629
supra
to
the
organisms").
Hearing,
136—136y
Meeting
Secretary).
basically
NEPA).
327.
1,
Chakrabarty,
guidelines
release
Biotechnolggy
(statement
not
as
Ifl}BLic.atLgns . . . H e a r i n g ,
228
committee
committee
Committee,
W. Gartland, Executive
(statement
Applications
174, at 5 . E P A h a s
47,174.
on B i o t e c h n o l o g y
12
note
(1982).
(1982).
237,
exempted
at
89
from
329.
49
0.
Fed.
Id..
Reg.
at
40
C.F.R.
332.
49
FFeedd..
obtain
the
been
from
334.
See
(statement
and
Toxic
and
issues a new
337.
338.
to
the requirement
that
crops
levels for the p e s t i c i d e
be
have
Hearing*.
supra
note
Administrator
237,
for;
at
90
Pesticides
EPA).
Protection
Small
not
Scale
final.
at
Agency, Microbial
Field
for
It s h o u l d
The policy
policy
50,883
and
Agency,
Pesticides
(Oct.
as
(citing
Pesticides
Protection
Agency
See
from
Assistant
at 4 0 , 6 6 1 .
Counsel,
Protection
order
Testing,
Pesticides;
49
Fed.
Reg.
that
EPA's
policy
(1984).
IdL
Administrator
in
Id.
tolerance
biotechnology
Environmental
requirement
Id.
on
Id;.
is interim
An a d d i t i o n a l
not be conducted
control.
if
Environmental
336.
must
exemption
J. Moore,
40,659, 40,660
(1985).
50,885.
Biotechnology
Policy
General
pest
Substances,
335.
Interim
of
at
itself
is available
established.
172.2(a)
Reg.
An
destroyed
s
experiment
benefits
50,885.
50,891.
331.
is t h a t
at
26,
and
be noted
may
be
changed
when
EPA
anticipated.
memo from Abramson,
Associate
Toxic
Division,
Substances
to Don Clay, Acting
Toxic
Substances,
Assistant
Environmental
1983)).
Insuring_Ssfety_in_Genetic_Engineering,
10 E P A
J.
7a
32, 32
<June
Hearings,
William
supra
note
Teweles
considered
chemical
a
bacteria
if
and
fits
339.
(D.D.C.
341.
license,
outside
you
very
than
supra
California
was
required
Sun,
supra
note
subjected
be
reviewing
the
a
ecologist.
that
Act.
1975)
See
(stating
EPA
See
has
required
additional
id.
Before granting
the
the scientist
his
argument
the
experiment.
a
that
a
of
upon
rainfall
T h e ad
included
pathologist,
ecologist,
85-3649
t o an ad h o c c o m m i t t e e
notification
Judge
EPA
Ref u s e s
9 Chem.
caution
Wyoming
that
1296.
ice-nucleating
a
hoc
soil
miqrohiologist-
meteorologist,
and
a
Id..
Federal.
of
by
plant
microbial
exercise
protection
your
also contacted
based
disrupted
The court's finding
an
crop
then
1015.
the proposal
Rifkin
"Ice—Minus"_Experiment,
been
not
protection
Trends v. Thomas, No.
175, at
The agency
Jeremy
See
lis]
scientists to furnish
on Economic
See
a
Kidd,
a crop
cover
by the NIH.
1985).
toxicologist,
(1986).
2 8 0 , at
of
microbiologist,
342.
note
14,
could
community
pesticides,
Nov.
whose research
to
of G e o r g e
bacteria
is considered
CFIFRAD
filed
had
(statement
("ice-nucleating
but.it
and__ A g r i c u l t u r e
nicely").
scientists.
committee
318
at
consider
Foundation
EPA
patterns
240,
just
Sun,
University
340.
Biotechnology
Co.)
not
See
information
&
gUt__See
pesticide,
Cslo
chemicals
the
1984).
-Reg.
t o _ E n j o i n _ E P A „ P e r m i t ...f o r
Rep.
(BNA)
that EPA complied
because EPA
is generally
002H2
with NEPA may
is generally
v . Hathaway, 525 F.2d
exempt
1571,
exempt
66, 71-72
from
(10th
NEPA),
1571
have
from
Cir.
cert..
denied,
426
237, at 89
906
(statement
(1976);
of
B i g t e c h n q l ggyj.Hear L n g ,
Rep.
Dingell)
276, 286
(E.D.N.C.
required
to
(statement
has N E P A
programs,
Jeremy
Rifkin
FIFRA
by
Hearing,
Director
EPA.
support
Hilts,
Post, Mar.
25,
344.
EPA
Field
Reg.
local
System
17
Federal
only
research
activities, and new
and
source
permits).
violations
Chem.
Reg.
(BNA)
Emerson
of
NEPA
Rep.
(BNA)
firm
was
falsifying
Washington
fined
for
information
Id..
experiment
was
to
was required.
15, 1986.
See
be
carried
Permission
Califgrnia
had
Gives
IceHjinus^.Bacter iaL„Lawsuit_Pending,
1302,
1307
has raised
are
the question
not
scientific
9
(1986).
of
that suppress scientific
because they
regulate
The
and for knowingly
January
regulations
to
3.
state permission
Iest_gf
Rep.
constitutional
available
grants,
Iesting..„gf.Microbe, T h e
the strawberry
effective
Professor
and
Halts
a p p l legation.
Because
been g r a n t e d
Chem.
9
1986, at A5, col.
out in C a l i f o r n i a ,
to
of
at
S e e P e r m i t__Reguired_ f g r _ _ I c e s M i n u s _ T e s t i „ I B A
its EPA permit
on t h i s p e r m i t
Okay
not
(1986).
343.
violating
is
note 228.
Office
h i s s u i t on a l l e g e d
Admi t t e d _ a s _ I n t e r v e n g r _ i n _ L a w s u ^
1515
Supp.
complies with NEPA, but
Discharge Elimination
based
note
specifically
that EPA
supra
in c o n s t r u c t i o n
facility
supra
State, 528 F.
v.
of
voluntarily
responsibilities
Pollutant
CEQ
Hirsch,
(EPA
is
(listing cases holding
EIS);
A.
EPA)
development
National
1981)
file
of
Activities,
1515,
(EPA
-from N E P A ) ; s e e . _ a l s o W a r r e n C o u n t y
exempt
and
U.S.
the
least
research.
002.13
whether
state
information
drastic
Science
are
means
Policy
4
Report,
supra
School
of
Law).
California
See
Science
required
The
constitutional
Sun,
firm
experiment.
in t h e
at 60
(statement
667
to
(1986).
obtain
Authority
health
posed
experiment.
1458
See
(statement
of
347.
a land
for
the
s
mixture
of
Rep.
136u
8< A d l e r ,
(1982)
ordinance
substances
9 Chem.
in
the
Test,
ordinance
conduct
on
the
(i.e.,
Reg.
mitigating
& Adler,
that
broad
pesticides,
forms
the
the
danger
bacteMa)
Rep.
(BNA)
that
or
supra
"Etlhe
can
237,
302, at
at
as
10,374-75;
"any
83
intended
for
see
substance
preventing,
can
language
includes
be
and
"Biorational"
of
note
authority.
. . . ."
Availability
note
pest
organisms
definition
control
note
7
or
destroying,
use
as
a
plant
desicant").
regulatory
which
of
any
living
it determined
supra
for
McChesney
considered
supra
intended
348.
of
to
"animals"
pesticide
or
Notice
County
was based
(defining
def ol i a n t
Regulation
raised
Sikorski).
regul a t o r
biological
permit
Biotechnology.....Hearing,
or
life
Yale
Ice-M.i n u s _ F i el d . . J e s t i n . C a l i f o r n i a .Put._on
repelling
very
Monterey
use
b y t h e u s e of
See
McChesney
U.S.C.
a
Emerson,
(1986).
346.
when
Thomas
Halts. .Biotechnology
The
Hgl_d__Af.ter_Mgnterey_.Cgunty__Hearing,
1458,
of
issue was not
L o c a l ..Opposition.
667,
the
to p u b l i c
15,
case.
345.
231
note
302,
of
FIFRA
diverse
utilized
Pesticides;
in
to
the
Document,
1979,
Agency
macroscopic
programs
Fed.
of
Agency,
Statement
44
has
biological
Protection
Policy
EPA
since
gives
As applied
Environmental
Background
10,375.
be pesticides
the many
are
at
and
Reg.
75
28,093,
of
28,094
most
biological
Agency,
from
(1979).
Certain
control
46 Fed.
349.
McGarity,
350.
15 U . S . C .
351.
Id..
352.
49
note
definition
353.
supra
Fed.
Reg.
at
507
chemical
See
49
(answer
chemical
organisms
Reg.
supra
of
any
are chemical
include
life
purposes
. . . ."
as
forms
living
stated
that
may
Bayer,
a
genetically
the
statutory
But_see
224
Reg.
that
their
genetically
64,572,
over
from
G.
complete
the
the
EPA
nor
the years.
does
for
(1977).
rDNA
molecules
only
Administrator
I
intended."
In
not
commercial
64,584
concluded
which
engineered
"definition
organisms could
interpretation
contemplated
(letter
manufactured
whereas
hosn
if
Environmental
("no o n e k n o w s t h e
the
be
that
neither
at
whether
substances.
Congress
&
organism").
of
which
substances
"an
fit
substances has changed
reasoned
was
within
to
at 5 0 , 8 8 7 .
things were chemical
this
(1981).
149.
seem
note 200,
42 Fed.
substances,
chemical
Exemption
substance").
1977, the Administrator
chemical
Proposed
18,323
molecule
would
determination
Administrator
Protection
see.also McGarity
to committee question)
make—up
EPA's
regulation
(1982).
("DNA
Fed.
lQlBLicati.ons_Heac.ing,
Karny)
18,322,
at 5 0 , 8 8 6 ;
micro-organism
of
Agents;
n o t e 2 9 1 , at
s 2603
for
See Environmental
Control
Reg.
to USDA
s 2 6 0 2 ( 2 ) (A) .
81,
engineered
agents.
Biological
Regulation,
suBCa
EPA has deferred
be
The
were
defined
t h a t all
living
Costle
stated
am confident
Letter
to
that
Sen.
Adlai
Stevenson
reprinted.in
-from
(1982)).
200, at
49
Sess.
8R
Reg.
at
50,887
(quoting
from
of
occurring
nature,
G. Karny)
chemical
but
(answer
substance
I would
Its
15 U . S . C .
read
s
refer
that
1502(2)
supra
note
question)
to
substances
as the
k e y part*, o f
definition").
355.
49
356.
Compare
200, at
224
covers
Fed.
Reg.
has
from
reservations
on
supra
202,
whatsoever
50,887.
G. Karny)
developed
genetically
note
at
E n v i r o n m e n t a 1 _. I m p I_ i.c a t i o n s _ H e a r i.ng, s u p r a
(letter
("consensus
among
modified
issue)
with
at
exists
33
(answer
organisms,"
Congress
Genetically
Engineered
Microbial.
("close
examination
of
debate
surrounding
passage
or n o t
Congress
broadly
the Senate
intended
as
to
the
staff
of
TSCA
is
that
"no
TSCA
10,2S1
reports
inconclusive
as
to be
genetically
engineered
Subcommittee
on
cover
Regulating
the
10,279,
House
indication
to
Under
'chemica>'substances'
include
probably
Report,
arid S c h i f f b a u e r ,
L. Rep.
and
TSCA
Implications
Products
15 E n v t l .
question)
personal
intended
life forms")
note
expressing
argument
engineered
Substances_Cgntrol_Act,
that
but
Environmental
(noting
^frtat
to committee
the experts
genetically
so
and
to committee
does
not
FPA
(1978).
Envirgn.mental..Impl i c a t i p n s . H e a r i n g ,
(letter
in
DNA. Research
2d
("definition
the
Admini strat.or,
Cong.,
Fed.
But_see
224
Costle
O y e r si g h t _ R e p o r t , _ R e c o m b i n a n t
AfiP.Li.gat.ions, 9 5 t h
354.
Douglas
and
to
Toxic.
(1985)
floor
whether
interpreted
microbial
products").
In
1984,
Oversight
of
the
of
House
the
Committee
on
Investigations
Science
and
and
Technology
recommended
that
genetically
because
engineered
EPA
authority,
had
new
subcommittee
expressed
in
light
EPA use TSCA
not
its poor
Implications
357.
(statement
358.
of
Rep.
supra
United
covered
existence
of
ability
in
stated
that
sufficient
at that
time.
The
under
TSCA,
but
under
TSCA
to regulate
the
n o t e 202, at
past.
Environmental
50.
Hearing,
States
supra
v. Chakrabarty,
whether
genetically
such
actions
of
note
237,
at
83
Sikorski).
In d e t e r m i n i n g
(1982),
EPA's
EPA's
Bi o t e c h n g l g g y
See
(1980).
about
releases
provided
unnecessary
performance
Report,
See
TSCA
was
endorse
direct
The subcommittee
that
legislation
did
regulate
organisms.
concluded
reservations
of
to
organisms
the Patent
engineered
447 U.S.
303,
Act, 35 U.S.C.
organisms
316
s
when
were not foreseeable when
101
the
the Act
was
*
passed,
447
the Court
U.S.
at 3 1 6 .
and T S C A .
that
when
that
not
to apply
Act was
360.
Memorandum
from
Acting
Assistant
Substances, EPA
Implications
<Oct.
Report,
the Act
designed
applicable.
the Patent
to
apply
the Act was
substances
that
Act
to
passed,
did
not
passed.
Reg.
Toxic
was
to chemical
See 49 Fed.
and
Act
foreseeable when
359.
Pesticides
l a n g u a g e of
can be made between
Patent
were
TSCA w a s designed
the broad
An analogy
Whereas the
inventions
exist
found
at
50,887.
S.
Abramson,
Substances
Division,
Administrator
for
26,
1983),
General
EPA,
to
Don
Clay,
Pesticides
and
Toxic
reprinted__in
sugra note 202,
00?37
at
Counsel,
146,
150.
Environmental
yk
361.
49 Fed.
62.
Reg.
Id.,
could
result
the
potential
at 5 0 , 8 8 9 .
in
expressed.
for
Id...
the_EnyiconmeQt:
•fraction
of
turned
generally
the hundred
v»-v >•
or
committee
on
TSCA
TSCA
71-72,
because
bacteria
of
being
in
in B i o t e c h n o l u ^ a n d
1.03 ( 1 9 8 5 )
or
deletion
Biotechnology...
("only
y;-ui>s t h a t
•'
une
gene expression
emoU
,:.-
... pj^rst
time
Car-id 1
is turned
reprinted
"specifically
chemical
Gdnf.
in
exemptCsl
1649, 94th
U.S.
from
Id..
at
or
on
we
and
at 4 5 5 6 - 5 7 .
engaged
for
or
8< A d .
stated
The only
in t h e e x p e r i m e n t
processed
substance
1976 U . S .
requirement
be notified
00238
the
Sess.
64,
News
4539,
that
TSCA
those
. . .
chemical
the
into a
Code
5
an
or
requirements
analysis for
repr.inted._.i.n
health
C o n g . , 2d
a n a l y s i s or f o r
chemical
section
presenting
public
committee
research,-ana
71-72,
the
conference
to apply
the notification
or
another
The
Code Cong.
manufactured
including
substance
News
Rep.
experimentation
or a n a l y s i s ,
product."
to
conference
substances
scientific
the potential
harm
1976
The
(1982).
a Senate proposal
that had
of
H.R.
4556-57.
people
99,
2604(h)(3)
rejected
risk
environment.
Ad.
s
to experiments
unreasonable
the
the
Hardy,
«m
of h o w
gene
off").
U.S.C.
of
turned
of
Concerns,
thousand
little
15
4549,
PotentialA
that
to the o r g a n i s m
functions
Ri.sk.Regulation
364.
of
has determined
change
other
See
expreaso.-;]
understand
ERA
a significant
A g r i E H l ture.:..__. Status.,,
are
50,387.
Id
363.
cell
at
for
research
development
commercial
Cong.
in s u c h c a s e s
of p o t e n t i a l
is
8<
that
health
risks.
News
Id.
at
21,
at
72,
15 U . S . C .
366.
49
at
creation
Fed.
o-f n e w
chemical
49 Fed.
368.
Id...
369.
Id...
370.
The
adopted)
Reg.
(TSCA
scientific
"The
exemption
innovation,
Cong.
?< A d .
in
of
is
necessary
of
Sess.
committee's
finding,
technology,
may
"technically
qualified
be made
come
a w a r e of
substance!".
unknown
that
to
and
from
5."
the
the
exemption
that
Rep.
this
No.
Potential
in d i r e c t
engineered
organisms.
committee's
conclusion
is faulty
Thus
when
the
to
rDNA
the
that
the
substance!
effects
environments
rationale
the exemption
impeded
House
conclusion
and
and
the
in
release experimentation
genetically
reads:
94th
and e n v i r o n m e n t a l
health
to
1341,
exemption
Tmanufacturing
health
applied
is not u n d u l y
the committee's
potential
committee
research
ambiguity
applying
for
The House report
insure
H.R.
exemption
conference
the
An
individuals
Id..
note
instance").
5's
commercial,
(1976).
when
section
research.
section
29
supra
t o inter-fere w i t h
in t h e f i r s t
(which
finding
academic
Note,
50,891.
commercial
both
2d
are
at
s e e ...also
intended
substances
and
requirements
effects
not
experimentation
academic
the
"is
version
was explicit
Cong.,
at 5 0 , 8 9 1 ;
Reg.
House
both
Cof
Code
2 6 0 4 (i). ( 1 9 8 2 ) .
862-63
367.
would
1976 U.S.
4557.
365.
by the
reprinted.„.in
involving
for
is applied
the
to
t
direct
release
experiments
involving
00?39
genetically
so
engineered
organx s m s .
371.
49 Fed.
Rsg.
at
50,000.
372.
S e e . . g e n e r a l l y K c G a r i t y , s u p r n n o t e 2 9 1 . ,-,t 1 4 5 .
373.
15 U.S.C.
374.
T h e S e n a t e bill
5 2605(a)
(19!??).
cpr.t* j r.
rlef i r.: t i.-.-. o f smrafre nneb-lp
*
risk' i d e n t i c a l
t*
(1902).
12? Ccno-
See
deliberately
th«
excluded
o n e be. i n c l u d e d .
definition
Rec.
in r i T R A ,
T h e Hons:? com.nitr.;n-
probability,
severity,
rather
requires
person
such
making
risk."
and
l.v.:.'hh)
s u g g e s t - , nr.
involves
a
factors
of
which
be
cannot-
determination
but
on
t h e p.*rt o ?
the
it, the C o m m i t t e e did not attempt a
definition
of
the
H.R.
i s n o t .t f a c t u a l
exercise
Rep.
of
No.
judgment
1341, 4th C o n g . , 2d S e s s .
that
of
conduct
test when deciding
EPA
risk
an
informal
existed.
"interpretCsl
Xdx.
at
Administrator
'unreasonable risk' under TSCA to
-in
magnitude
of h a r m t o s o c i e t y of t h e u s e nf a c h e m i c a l
outweigh
Priorities
the
a judgment
benefits."
for OTS Operation
375.
See McGarity
376.
Er.vironmental
if
an
mean
a
14.
situation
to
which
balancing
the
17,-14
The House committee recommended
unreasonable
the
cc.nsideratior.
(1976).
EPA
thai
t .-.taJ-ed: "r:srs..-.r
similar
terms and
*
T h e H.v.$r>e coiRa* *
a d e f i n i t i o n , rtospi h p t h e
of- u n r e a s o n a b l e r i s k
in p r e c i s e
U.S.C.
r>?9-. ?;'??,'>>.
determination
defined
7
is m a d e that the probability
Environmental
TV-7
(,1an.
& Bayer, supra
are
likely
Protection
Agency,
19B2).
note St. at
IiHpl.j.cati,gn§JJear.i Q Q »
00240
and
515-16.
supra
note 200,
at
8
155
of
(statement
Pesticides
377.
126
Toxic
of
at Austin);
Substances,
constitutes
378.
an
social,
and
Act
R.
40
7
U.S.C.
on
the
the
pesticide").
Rev.
Environmental
(D.C.
riski-benefit
the
Ordway,
1981)
The
("clear
in
at
of
Toxic
intent
determining
Cof
what
unreasonable
a n d b e n e f i t s of
&
(1974)
Inc.
the
the
The
of
any
Uses
of
Decisionmaking,
(stating
risk
economic,
use
Tarlock,
48
that the court
v. Ruckelshaus,
FIFRA
'unreasonable
»
into account
Environmental
pnstrued
("term
means any
Gelpe
417-19
analysis"
147,
439
to mandate
in a c c o r d a n c e w i t h E P A ' s
"a
F.2d
S.
in
584
comprehensive
construction
of
statute).
379.
(defining
H.R.
of t h a t
Rep.
No.
"unreasonable
probabilities
the
1971)
G.
(1982)
taking
generally
371,
note
of L a w , U n i v e r s i t y
be used
136(bb)
costs
Defense Fund,
Cir.
supra
risk").
environment,
See.
&
ed.
environment'
Sci. e n t i f i.c_Inf o r m a t i , o n _ i n
L.
(rev.
s
environmental
Office
EPA).
Druley
approach
unreasonable
effects
or
see_also
a balancing
See
man
Cal.
Administrator,
T. McGarity, Professor
Control
is that
adverse
Assistant
Potential_£SDsegkLences_Hearings,
Substances
TSCA3
D. Clay, Acting
and
(statement
Texas
to
of
that
harm
harm against
availability
1 3 4 1 , -94th C o n g . , 2 d S e s s .
risk"
will
occur
the effect
to society
in
of
TSCA
and
as
and
regulatory
t h e b e n e f i t s of
(1976)
"balancing
the magnitude
o-f p r o p o s e d
14
the
severity
action
the substance
on
or
mixture").
380.
Council
QyaLitv_1984;
on
Environmental
Fifteenth_Annual__Regort. 465
00241
Duality,
(1986).
Environmental,
381.
I.cjk
382.
C£^
at
465-66.
BL°technology
(statement
of
Rep.
regulatory
delays
inadequate
caution
^Hearing,
Dingell)
and
can
stifling
result
in
(rigid
of
00?2
note
regulations
industrial
judicial
di s a s t e r s ) .
supra
237,
can
at
cause
development
challenges and
2
but
terrible