Statutory Review of the Gene Tec hnology Act 2000 · 2019-12-03 · 180 Statutory Review of the...
44
178 Statutory Review of the Gene Technology Act 2000 SUMMARY — continued • The Economic Research Service (ERS) conducts research on the economic aspects of the use of genetically engineered organisms, including the rate of and reasons for adoption of biotechnology by farmers. • The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labelled and packaged including animals involved in biotechnology. • The National Agricultural Statistics Service (NASS), as the fact finder for agriculture, provides information on the adoption of biotechnology crops (specifically corn, cotton, and soybeans). Contained work with GMOs Responsible agency • National Institute of Health (NIH). Legislation • There is no special regulatory system for ensuring the safe use of biotechnology in the laboratory or factory where the organism is not to be released into the environment (i.e. contained use). Voluntary guidelines — the NIH’s Guidelines for Research Involving Recombinant DNA Molecules — are implemented by most users of the technology. Intentional releases of GMOs in the environment Responsible agency • The US Department of Agriculture Animal and Plant Health Inspection Service (for plant pests, plants and veterinary biologics). • The U.S. Environmental Protection Agency (for microbial/plant pesticides, new uses of existing pesticides and novel micro-organisms). Legislation • Federal Plant Pest Act; Federal Insecticide, Fungicide and Rodenticide Act; National Environment Policy Act; Plant Protection Act; Federal Food, Drug and Cosmetic Act; Food Quality Protection Act; Endangered Species Act.
Transcript of Statutory Review of the Gene Tec hnology Act 2000 · 2019-12-03 · 180 Statutory Review of the...
178
Statutory Review of the Gene Technology Act 2000
SUM
MA
RY —
con
tinue
d
• T
he E
cono
mic
Res
earc
h Se
rvic
e (E
RS)
con
duct
s re
sear
ch o
n th
e ec
onom
ic a
spec
ts o
f the
use
of g
enet
ical
ly e
ngin
eere
d or
gani
sms,
incl
udin
g th
e ra
te o
f and
rea
sons
for
adop
tion
of b
iote
chno
logy
by
farm
ers.
• T
he F
ood
Safe
ty a
nd In
spec
tion
Serv
ice
(FSI
S) is
the
publ
ic h
ealth
age
ncy
in th
e U
.S. D
epar
tmen
t of A
gric
ultu
re r
espo
nsib
le
for
ensu
ring
that
the
natio
n’s
com
mer
cial
sup
ply
of m
eat,
poul
try,
and
egg
pro
duct
s is
saf
e, w
hole
som
e, a
nd c
orre
ctly
la
belle
d an
d pa
ckag
ed in
clud
ing
anim
als
invo
lved
in b
iote
chno
logy
.
• T
he N
atio
nal A
gric
ultu
ral S
tatis
tics
Serv
ice
(NA
SS),
as th
e fa
ct fi
nder
for
agri
cultu
re, p
rovi
des
info
rmat
ion
on th
e ad
optio
n of
bi
otec
hnol
ogy
crop
s (s
pecifi c
ally
cor
n, c
otto
n, a
nd s
oybe
ans)
.
Con
tain
ed w
ork
wit
h G
MO
s
Res
pons
ible
age
ncy
• N
atio
nal I
nstit
ute
of H
ealth
(NIH
).
Legi
slat
ion
• T
here
is n
o sp
ecia
l reg
ulat
ory
syst
em fo
r en
suri
ng th
e sa
fe u
se o
f bio
tech
nolo
gy in
the
labo
rato
ry o
r fa
ctor
y w
here
the
orga
nism
is n
ot to
be
rele
ased
into
the
envi
ronm
ent (
i.e.
cont
aine
d us
e). V
olun
tary
gui
delin
es —
the
NIH
’s G
uide
lines
for
Res
earc
h In
volv
ing
Rec
ombi
nant
DN
A M
olec
ules
— a
re im
plem
ente
d by
mos
t use
rs o
f the
tech
nolo
gy.
Inte
ntio
nal r
elea
ses
of G
MO
s in
the
env
iron
men
t
Res
pons
ible
age
ncy
• T
he U
S D
epar
tmen
t of A
gric
ultu
re A
nim
al a
nd P
lant
Hea
lth In
spec
tion
Serv
ice
(for
plan
t pe
sts,
pla
nts
and
vete
rina
ry b
iolo
gics
).
• T
he U
.S. E
nvir
onm
enta
l Pro
tect
ion
Age
ncy
(for
mic
robi
al/p
lant
pes
ticid
es, n
ew u
ses
of
exis
ting
pest
icid
es a
nd n
ovel
mic
ro-o
rgan
ism
s).
Legi
slat
ion
• F
eder
al P
lant
Pes
t Act
; Fed
eral
Inse
ctic
ide,
Fun
gici
de a
nd R
oden
ticid
e A
ct; N
atio
nal
Envi
ronm
ent P
olic
y A
ct; P
lant
Pro
tect
ion
Act
; Fed
eral
Foo
d, D
rug
and
Cos
met
ic A
ct; F
ood
Qua
lity
Prot
ectio
n A
ct; E
ndan
gere
d Sp
ecie
s A
ct.
179
and the Gene Technology Agreement
Cov
erag
e of
the
legi
slat
ion
• F
ield
test
ing,
mov
ing,
impo
rtin
g an
d co
mm
erci
al r
elea
se o
f org
anis
ms
and
prod
ucts
alte
red
or p
rodu
ced
thro
ugh
gene
tic e
ngin
eeri
ng w
hich
are
pla
nt p
ests
or
may
bec
ome
plan
t pe
sts.
Und
er th
e Pl
ant P
rote
ctio
n A
ct, A
PHIS
reg
ulat
es p
lant
s th
at m
ay p
ose
such
a r
isk.
O
rgan
ism
s an
d pr
oduc
ts th
at a
re k
now
n or
sus
pect
ed to
be
plan
t pes
ts o
r to
pos
e a
plan
t pe
st r
isk,
incl
udin
g th
ose
that
hav
e be
en a
ltere
d or
pro
duce
d th
roug
h ge
netic
eng
inee
ring
ar
e ca
lle d
‘reg
ulat
ed a
rtic
les’
.
• I
nten
tiona
l con
fi ned
rel
ease
into
the
envi
ronm
ent o
f reg
ulat
ed a
rtic
les
requ
ire
notifi
cat
ion
to th
e re
leva
nt a
utho
rity
und
er th
e re
leva
nt le
gisl
atio
n.
• ‘
Gen
etic
eng
inee
ring
’ is
defi n
ed a
s th
e ge
netic
mod
ifi ca
tion
of o
rgan
ism
s by
rec
ombi
nant
D
NA
tech
niqu
es. T
here
is n
o de
fi niti
on o
f ‘re
com
bina
nt D
NA
tech
niqu
es’.
• T
he F
eder
al F
ood,
Dru
g an
d C
osm
etic
Act
, Foo
d Q
ualit
y Pr
otec
tion
Act
and
End
ange
red
Spec
ies
Act
are
als
o co
nsid
ered
by
the
EPA
whe
n ev
alua
ting
the
risk
s th
at b
iope
stic
ides
(in
clud
ing
thos
e th
at e
ither
are
, or
res
ult f
rom
, GM
Os
or G
M te
chni
ques
) may
pos
e to
the
envi
ronm
ent o
r hu
man
hea
lth.
• T
he F
eder
al F
ood,
Dru
g an
d C
osm
etic
Act
gov
erns
the
FDA
in a
sses
sing
the
safe
ty o
f foo
ds/
feed
s fro
m n
ovel
pla
nt v
arie
ties
(incl
udin
g ge
netic
ally
eng
inee
red
plan
ts);
the
Food
Qua
lity
Prot
ectio
n A
ct im
pose
s st
anda
rd to
lera
nces
for a
llow
able
leve
ls o
f pes
ticid
es in
food
; whe
reas
th
e En
dang
ered
Spe
cies
Act
ens
ures
that
any
pes
ticid
es (i
nclu
ding
thos
e de
rived
from
GM
Os
or te
chni
ques
) do
not p
ose
a ris
k to
end
ange
red
spec
ies.
Ass
essm
ent p
roce
ss fo
r in
tent
iona
l rel
ease
of a
GM
O
into
the
envi
ronm
ent (fi e
ld
tria
ls)
• T
he d
evel
oper
sub
mits
a n
otifi
catio
n to
the
APH
IS (n
otifi
catio
n to
APH
IS o
f an
envi
ronm
enta
l rel
ease
mus
t be
at le
ast 1
20 d
ays
prio
r to
rel
ease
, but
this
can
be
exte
nded
if
an e
nvir
onm
enta
l im
pact
sta
tem
ent i
s re
quir
ed in
add
ition
to a
n en
viro
nmen
tal r
isk
asse
ssm
ent,
and
in th
e ca
se th
at a
dditi
onal
info
rmat
ion
is s
ubse
quen
tly r
equi
red,
the
120
day
peri
od w
ill s
tart
upo
n th
e re
ceip
t of t
he a
dditi
onal
info
rmat
ion)
.
• D
ata
mus
t dem
onst
rate
that
the
plan
t is
safe
to r
elea
se a
nd is
not
itse
lf a
plan
t pes
t or
pote
ntia
l nox
ious
wee
d.
Appendix 8
180
Statutory Review of the Gene Technology Act 2000
Ass
essm
ent p
roce
ss fo
r in
tent
iona
l rel
ease
of a
GM
O
into
the
envi
ronm
ent (fi e
ld
tria
ls) (
cont
inue
d)
• T
he A
PHIS
con
duct
s an
ass
essm
ent.
APH
IS h
as a
two
tiere
d le
vel o
f ris
k —
low
er r
isk
GM
Os
(for
exam
ple,
pla
nts
that
are
alte
red
with
com
mon
agr
onom
ic tr
aits
suc
h as
pes
t or
herb
icid
e re
sist
ance
) nee
d on
ly b
e no
tifi e
d to
the
agen
cy, w
hile
oth
er r
elea
ses
that
pos
e an
ele
vate
d ri
sk (s
uch
as p
lant
s th
at p
rodu
ce p
harm
aceu
tical
or
indu
stri
al c
ompo
unds
and
G
MO
s ot
her
than
pla
nts)
req
uire
a p
erm
it.
• T
here
are
six
cri
teri
a th
at a
pla
nt h
as to
mee
t bef
ore
bein
g co
nsid
ered
by
APH
IS fo
r no
tifi c
atio
n: i
t is
eith
er c
orn,
cot
ton,
pot
ato,
soy
bean
, tob
acco
, tom
ato
or a
ny a
dditi
onal
pl
ant s
peci
es th
at B
RS
has
dete
rmin
ed m
ay b
e sa
fely
intr
oduc
ed; t
he in
trod
uced
gen
etic
m
ater
ial i
s st
ably
inte
grat
ed; t
he fu
nctio
n of
the
intr
oduc
ed g
enet
ic m
ater
ial i
s kn
own
and
its e
xpre
ssio
n in
the
regu
late
d ar
ticle
doe
s no
t res
ult i
n pl
ant d
isea
se; t
he in
trod
uced
ge
netic
mat
eria
l doe
s no
t (1)
cau
se th
e pr
oduc
tion
of a
n in
fect
ious
ent
ity, (
2) e
ncod
e su
bsta
nces
that
are
kno
wn
or li
kely
to b
e to
xic
to n
on-t
arge
t org
anis
ms
know
n or
like
ly to
fe
ed o
r liv
e on
the
plan
t spe
cies
, or
(3) e
ncod
e pr
oduc
ts in
tend
ed fo
r ph
arm
aceu
tical
use
; th
e in
trod
uced
gen
etic
seq
uenc
es d
eriv
ed fr
om p
lant
vir
uses
do
not p
ose
a si
gnifi
cant
ris
k of
the
crea
tion
of a
ny n
ew p
lant
vir
us; t
he p
lant
has
not
bee
n m
odifi
ed to
con
tain
cer
tain
ge
netic
mat
eria
l der
ived
from
an
anim
al o
r hu
man
pat
hoge
n.
• N
otifi
catio
ns a
re r
equi
red
to c
onta
in:
spec
ifi c
info
rmat
ion
on th
e ge
netic
trai
t int
rodu
ced,
in
clud
ing
its o
rigi
ns; h
ow th
e ex
pres
sion
of t
he tr
ait d
iffer
s to
the
non-
mod
ifi ed
cou
nter
part
; in
form
atio
n on
pro
pose
d pr
oced
ures
and
saf
egua
rds
to p
reve
nt e
scap
e, d
isse
min
atio
n an
d co
ntam
inat
ion;
pro
pose
d m
etho
d of
fi na
l dis
posi
tion.
• W
hile
ther
e ar
e no
siz
e re
stric
tions
on fi e
ld tr
ials
, APH
IS o
ffi ci
als
take
into
con
side
ratio
n th
e si
ze o
f the
fi el
d tri
al w
hen
they
det
erm
ine
the
sign
ifi ca
nce
of th
e im
pact
on
the
envi
ronm
ent.
• A
PHIS
forw
ards
the
notifi
cat
ions
on
to re
leva
nt s
tate
age
ncie
s fo
r com
men
t with
in fi
ve d
ays
of re
ceip
t of t
he n
otifi
catio
n. S
tate
aut
horit
ies
can
com
men
t at t
heir
disc
retio
n, b
ut c
omm
ents
fro
m s
tate
aut
horit
ies
are
not r
equi
red
for t
he p
rogr
essi
on o
f the
ass
essm
ent p
roce
ss.
181
and the Gene Technology Agreement
Ass
essm
ent p
roce
ss fo
r in
tent
iona
l rel
ease
of a
GM
O
into
the
envi
ronm
ent (fi e
ld
tria
ls) (
cont
inue
d)
• I
n as
sess
ing
an a
pplic
atio
n fo
r a
perm
it, th
e A
PHIS
: m
ust b
e sa
tisfi e
d th
at th
e be
nefi t
s of
th
e pr
opos
al o
utw
eigh
the
cost
s; m
ay r
equi
re th
e pr
epar
atio
n of
an
envi
ronm
enta
l im
pact
st
atem
ent i
n ad
ditio
n to
an
envi
ronm
enta
l ass
essm
ent;
mus
t see
k pu
blic
com
men
t on
a pr
opos
al if
a p
erso
n ha
s su
bmitt
ed to
the
APH
IS a
pet
ition
to s
eek
a de
term
inat
ion
that
a
part
icul
ar G
MO
sho
uld
not b
e re
gula
ted
unde
r th
e le
gisl
atio
n; fi
eld
tria
l res
ults
mus
t be
subm
itted
to A
PHIS
with
in 6
mon
ths
of th
e te
rmin
atio
n of
a fi
eld
tria
l; .
APH
IS th
en m
akes
a
deci
sion
to a
ppro
ve th
e pe
titio
n in
who
le o
r in
par
t, or
to d
eny
the
petit
ion;
and
mus
t co
nsul
t Dep
artm
ents
of A
gric
ultu
re in
the
Stat
es w
here
rel
ease
is p
lann
ed.
• I
f the
GM
O is
als
o a
plan
t pes
ticid
e (p
lant
-inc
orpo
rate
d pr
otec
tant
; PIP
) the
n EP
A a
ppro
val
is a
lso
requ
ired
und
er th
e Fe
dera
l Ins
ectic
ide,
Fun
gici
de a
nd R
oden
ticid
e A
ct a
s pe
stic
ide
is
broa
dly
defi n
ed to
incl
ude
plan
ts m
odifi
ed b
y bi
otec
hnol
ogy
to r
esis
t dis
ease
. The
EPA
may
al
so tr
eat m
icro
-org
anis
ms
as s
ubje
ct to
the
Toxi
c Su
bsta
nces
Con
trol
Act
.
• A
‘det
erm
inat
ion
of n
on-r
egul
ated
’ sta
tus
is is
sued
by
APH
IS if
the
crop
is n
ot a
pla
nt p
est
allo
win
g th
e cr
op to
be
rele
ased
with
out r
estr
ictio
n. E
PA w
ould
als
o is
sue
appr
oval
.
• I
n th
e ca
se o
f PIP
s or
GM
mic
ro-o
rgan
ism
s fo
r pe
stic
ide
use,
the
EPA
doe
s an
eva
luat
ion
to a
sses
s th
e ri
sk:
to h
uman
hea
lth a
nd th
e en
viro
nmen
t; to
non
-tar
get o
rgan
ism
s; fo
r po
tent
ial g
ene fl o
w.
Con
side
ratio
n of
eth
ical
is
sues
• T
he o
nly
mat
ter
cons
ider
ed b
y A
PHIS
is w
heth
er th
e pl
ant i
s a
plan
t pes
t or
has
the
pote
ntia
l to
be a
pla
nt p
est.
Ethi
cs, t
rade
and
soc
ial i
ssue
s ar
e no
t tak
en in
to a
ccou
nt.
• H
owev
er, u
nder
the
Nat
iona
l Env
iron
men
tal P
olic
y A
ct th
e C
ounc
il on
Env
iron
men
tal
Qua
lity
take
s in
to a
ccou
nt th
e sc
ient
ifi c,
eco
nom
ic, s
ocia
l, ae
sthe
tic, a
nd c
ultu
ral n
eeds
an
d in
tere
sts
of th
e na
tion.
Appendix 8
182
Statutory Review of the Gene Technology Act 2000
Publ
ic c
onsu
ltatio
n on
ap
plic
atio
ns•
The
APH
IS o
nly
seek
s pu
blic
com
men
t on
a pr
opos
al if
a p
erso
n ha
s su
bmitt
ed to
the
APH
IS a
pet
ition
to s
eek
a de
term
inat
ion
that
a p
artic
ular
GM
O s
houl
d no
t be
regu
late
d un
der
the
legi
slat
ion.
APH
IS th
en m
akes
a d
ecis
ion
to a
ppro
ve th
e pe
titio
n in
who
le o
r in
pa
rt, o
r to
den
y th
e pe
titio
n. A
per
iod
of 6
0 da
ys is
giv
en fo
r pu
blic
con
sulta
tions
on
the
petit
ion.
• I
n co
nduc
ting
risk
ass
essm
ents
, the
dat
a us
ed b
y th
e EP
A u
nder
goes
ext
ensi
ve p
ublic
co
mm
ent a
nd p
eer
revi
ew b
y sc
ient
ifi c
expe
rts.
Prot
ectio
n of
con
fi den
tial
com
mer
cial
info
rmat
ion
• E
ach
of th
e re
leva
nt p
iece
s of
legi
slat
ion
prov
ide
for
the
prot
ectio
n of
con
fi den
tial
com
mer
cial
info
rmat
ion.
• P
ropo
nent
s ap
plyi
ng to
APH
IS fo
r a
perm
it m
ust p
rovi
de tw
o co
pies
of t
heir
app
licat
ion,
on
e w
ith c
onfi d
entia
l bus
ines
s in
form
atio
n pa
ssag
es m
arke
d an
d th
e ot
her
with
thes
e pa
ssag
es r
emov
ed.
Con
ditio
ns th
at m
ay b
e ap
plie
d•
APH
IS p
erm
its a
re s
ubje
ct to
sev
eral
con
ditio
ns p
resc
ribe
d in
the
regu
latio
ns, i
nclu
ding
: se
para
tion
of th
e G
MO
from
oth
er o
rgan
ism
s; tr
eatm
ent o
f mat
eria
l acc
ompa
nyin
g th
e G
MO
; com
plia
nce
with
mea
sure
s pr
escr
ibed
by
APH
IS w
hich
are
nec
essa
ry to
pre
vent
the
acci
dent
al o
r un
auth
oris
ed r
elea
se o
f the
GM
O; t
he r
equi
rem
ent t
hat t
he G
MO
be
subj
ect
to th
e ap
plic
atio
n of
rem
edia
l mea
sure
s de
term
ined
by
APH
IS to
be
nece
ssar
y to
pre
vent
th
e sp
read
of p
lant
pes
ts; t
he m
aint
enan
ce o
f the
GM
O o
nly
in th
e ar
eas
pres
crib
ed in
the
perm
it; a
nd in
spec
tors
mus
t be
allo
wed
acc
ess,
dur
ing
regu
lar
busi
ness
hou
rs, t
o pl
aces
w
here
the
GM
O is
loca
ted,
and
to r
ecor
ds r
elat
ing
to th
e in
trod
uctio
n of
the
GM
O.
• I
n ad
ditio
n, th
e pe
rmit
hold
er c
an b
e su
bjec
t to
any
othe
r co
nditi
ons
APH
IS d
eem
s as
ne
cess
ary
to p
reve
nt th
e di
ssem
inat
ion
and
esta
blis
hmen
t of p
lant
pes
ts.
Perm
it ca
n be
w
ithdr
awn
if no
n-co
mpl
ianc
e w
ith th
ese
cond
ition
s is
iden
tifi e
d.
• U
nusu
al o
ccur
renc
es (t
o th
ose
spec
ifi ed
in th
e ap
plic
atio
n, s
uch
as h
ighe
r ra
tes
of
mor
bidi
ty o
r m
orta
lity)
and
sus
pect
ed a
ccid
enta
l or
unau
thor
ised
rel
ease
of a
reg
ulat
ed
artic
le m
ust b
e no
tifi e
d to
APH
IS w
ithin
the
timef
ram
es s
pecifi e
d in
the
regu
latio
ns.
183
and the Gene Technology Agreement
Mon
itori
ng, s
urve
illan
ce a
nd
enfo
rcem
ent p
ower
s•
Onc
e pe
rmis
sion
for
the
culti
vatio
n of
a tr
ansg
enic
cro
p ha
s be
en g
rant
ed, p
rogr
ess
is
mon
itore
d. T
he s
yste
m d
oes
not r
ely
on s
ignifi c
ant e
nfor
cem
ent p
ower
s as
the
regu
lato
ry
syst
em is
bas
ed o
n ‘p
erm
its, t
estin
g an
d to
lera
nce
setti
ng’.
• A
ny r
egul
ated
art
icle
intr
oduc
ed n
ot in
com
plia
nce
with
the
requ
irem
ents
sha
ll be
sub
ject
to
the
imm
edia
te a
pplic
atio
n of
suc
h re
med
ial m
easu
res
or s
afeg
uard
s as
an
insp
ecto
r de
term
ines
nec
essa
ry to
pre
vent
the
intr
oduc
tion
of s
uch
plan
t pes
ts.
(Und
er th
e Fe
dera
l Pl
ant P
est A
ct, t
he S
ecre
tary
of A
gric
ultu
re is
aut
hori
sed
to o
rder
pro
mpt
rem
oval
from
the
Uni
ted
Stat
es o
r to
sei
ze, q
uara
ntin
e, tr
eat,
appl
y ot
her
rem
edia
l mea
sure
s to
, des
troy
, or
othe
rwis
e di
spos
e of
, in
such
man
ner
as th
e Se
cret
ary
deem
s ap
prop
riat
e, c
erta
in r
egul
ated
ar
ticle
s w
hich
are
bel
ieve
d to
be
infe
sted
or
infe
cted
by
or c
onta
in a
pla
nt p
est.)
• A
cces
s sh
all b
e al
low
ed fo
r APH
IS a
nd S
tate
reg
ulat
ory
offi c
ials
to in
spec
t fac
ilitie
s an
d/or
th
e fi e
ld te
st s
ite a
nd a
ny r
ecor
ds n
eces
sary
to e
valu
ate
com
plia
nce
with
the
prov
isio
ns.
• F
ield
test
rep
orts
mus
t be
subm
itted
with
in 1
2 m
onth
s of
the
star
t of a
fi el
d tr
ial a
nd th
en
ever
y 12
mon
ths
thro
ugh
the
dura
tion
of a
fi el
d tr
ial.
Pena
lties
• V
iola
tions
rel
atin
g to
pla
nt p
ests
can
incu
r cr
imin
al o
r ci
vil p
enal
ties.
• A
ny p
erso
n w
ho v
iola
tes
the
regu
latio
ns, o
r w
ho fo
rges
or
coun
terf
eits
any
per
mit
can
be
puni
shed
cri
min
ally
by
a fi n
e no
t exc
eedi
ng U
S$50
00 o
r by
impr
ison
men
t not
exc
eedi
ng
1 ye
ar, o
r bo
th.
Such
vio
latio
ns m
ay a
lso
be d
ealt
with
civ
illy
with
the
max
imum
fi ne
bei
ng
US$
1000
. H
owev
er, d
epen
ding
on
the
natu
re o
f the
vio
latio
n cr
imin
al p
enal
ties
can
rang
e up
to a
fi ne
of U
S$50
,000
or
a ye
ar in
jail
or b
oth.
• F
ailu
re to
adh
ere
to B
RS
regu
latio
ns, p
erm
it co
nditi
ons
and
requ
irem
ents
can
res
ult i
n se
riou
s pe
nalti
es, i
nclu
ding
fi ne
s up
to U
S$50
0,00
0 pe
r ad
judi
catio
n.
Appendix 8
184
Statutory Review of the Gene Technology Act 2000
Ass
essm
ent p
roce
ss fo
r
unre
stri
cted
inte
ntio
nal
rele
ase
of a
GM
O in
to th
e en
viro
nmen
t
• W
hen
an a
pplic
ant h
as fi
eld
test
ed a
tran
sgen
ic c
rop
and
accu
mul
ated
eno
ugh
data
to
show
that
this
cro
p is
free
from
any
ris
k (c
ompa
red
to it
s un
mod
ifi ed
cou
nter
part
), th
e ap
plic
ant c
an p
etiti
on A
PHIS
that
the
tran
sgen
ic c
rop
shou
ld n
o lo
nger
be
cons
ider
ed a
re
gula
ted
artic
le (a
nd th
us fr
ee fr
om a
ny m
onito
ring
or
rest
rict
ion)
. D
epen
ding
on
the
prod
uct a
nd it
s in
tend
ed p
urpo
se, r
evie
ws
by th
e FD
A (i
f int
ende
d fo
r fo
od u
se) a
nd th
e EP
A
may
als
o be
req
uire
d.
• T
he p
etiti
on is
req
uire
d to
incl
ude
data
suc
h as
: a
desc
ript
ion
of th
e bi
olog
y of
the
plan
t bef
ore
it w
as g
enet
ical
ly e
ngin
eere
d; e
xten
sive
dat
a fr
om te
sts
desi
gned
to d
etec
t di
ffere
nces
bet
wee
n th
e G
E pl
ant a
nd th
e or
igin
al p
lant
; cha
ract
eris
atio
n of
gen
etic
ch
ange
s; p
lant
pes
t-ri
sk c
hara
cter
istic
s; d
isea
se a
nd p
est s
usce
ptib
ilitie
s; e
xpre
ssio
n of
gen
e pr
oduc
ts; n
ew e
nzym
es; e
ffect
s on
non
-tar
get o
rgan
ism
s; c
hang
es in
pla
nt m
etab
olis
m;
wee
dine
ss o
f the
GE
plan
t; im
pact
on
the
wee
dine
ss o
f rel
ativ
es o
f the
GE
plan
t; im
pact
s on
agr
icul
tura
l pra
ctic
es o
r on
oth
er a
gric
ultu
ral p
rodu
cts;
fi el
d-te
st r
epor
ts fo
r al
l tri
als
cond
ucte
d un
der
perm
it or
not
ifi ca
tion
proc
edur
es in
volv
ing
the
GE
plan
t.
• C
ompl
eted
pet
ition
s ar
e pu
blis
hed
on th
e Fe
dera
l Reg
iste
r an
d pu
blic
com
men
t can
be
acce
pted
for
60 d
ays
from
the
date
of t
he p
ublic
atio
n on
the
Fede
ral R
egis
ter.
Ass
essm
ent p
roce
ss fo
r
unre
stri
cted
inte
ntio
nal
rele
ase
of a
GM
O in
to th
e en
viro
nmen
t (co
ntin
ued)
• T
he a
dmin
istr
ator
will
, with
in 1
80 d
ays
of r
ecei
ving
a c
ompl
eted
pet
ition
, eith
er:
appr
ove
the
petit
ion
in w
hole
or
in p
art;
or d
eny
the
petit
ion.
• A
PHIS
ann
ounc
es it
s de
cisi
on o
n th
e Fe
dera
l Reg
iste
r bu
t he
deci
sion
doe
s no
t bec
ome
fi nal
for
anot
her
30 d
ays
duri
ng w
hich
tim
e A
PHIS
may
alte
r its
dec
isio
n sh
ould
add
ition
al
info
rmat
ion
beco
me
avai
labl
e.
Con
side
ratio
n of
eth
ical
is
sues
• U
nder
the
Nat
iona
l Env
iron
men
tal P
olic
y A
ct th
e C
ounc
il on
Env
iron
men
tal Q
ualit
y sh
all
have
acc
ount
of s
cien
tifi c
, eco
nom
ic, s
ocia
l, ae
sthe
tic, a
nd c
ultu
ral n
eeds
and
inte
rest
s of
th
e na
tion.
185
and the Gene Technology Agreement
Publ
ic c
onsu
ltatio
n on
ap
plic
atio
ns•
Com
plet
ed p
etiti
ons
are
open
to p
ublic
com
men
t for
a p
erio
d of
60
days
.
Prot
ectio
n of
con
fi den
tial
com
mer
cial
info
rmat
ion
• E
ach
of th
e re
leva
nt p
iece
s of
legi
slat
ion
prov
ide
for
the
prot
ectio
n of
con
fi den
tial
com
mer
cial
info
rmat
ion.
• P
ropo
nent
s ap
plyi
ng to
APH
IS fo
r a
perm
it m
ust p
rovi
de tw
o co
pies
of t
heir
app
licat
ion,
on
e w
ith c
onfi d
entia
l bus
ines
s in
form
atio
n pa
ssag
es m
arke
d an
d th
e ot
her
with
thes
e pa
ssag
es r
emov
ed.
Con
ditio
ns th
at m
ay b
e ap
plie
d•
Afte
r a
petit
ion
for
dere
gula
tion
is g
rant
ed, t
here
are
no
rest
rict
ions
on
the
GM
O fo
r w
hich
th
e pe
titio
n w
as a
ppro
ved.
Mon
itori
ng, s
urve
illan
ce a
nd
enfo
rcem
ent p
ower
s•
Non
e
Pena
lties
• N
o pe
nalti
es a
pply
, as
once
a r
egul
ated
item
has
bee
n pe
titio
ned
and
beco
mes
a
dere
gula
ted
item
, it c
an b
e fr
eely
mov
ed a
nd p
lant
ed w
ithou
t BR
S re
gula
tory
con
trol
and
th
eref
ore
is n
o lo
nger
sub
ject
to th
e A
PHIS
or
BR
S re
gula
tions
.
Plac
ing
on t
he m
arke
t G
MO
s in
tend
ed fo
r fo
od o
r fe
ed
Ass
essm
ent p
roce
dure
for
plac
ing
on th
e m
arke
t GM
Os
inte
nded
for
food
or
feed
• A
pplic
ants
sho
uld
cons
ult w
ith th
e U
SFD
A b
efor
e su
bmitt
ing
a no
tifi c
atio
n fo
r pla
cing
food
s de
rived
from
nov
el p
lant
var
ietie
s (in
clud
ing
thos
e ge
netic
ally
eng
inee
red)
on
the
mar
ket.
• Th
e co
nsul
tatio
n is
a tw
o-st
ep p
roce
ss.
Initi
al c
onsu
ltatio
ns s
houl
d st
art e
arly
in th
e de
velo
pmen
t of t
he n
ovel
food
or f
eed
and
are
desi
gned
to re
solv
e po
tent
ial s
afet
y, n
utrit
iona
l, an
d re
gula
tory
issu
es.
Such
issu
es m
ay in
clud
e, b
ut a
re n
ot li
mite
d to
, sig
nifi c
antly
incr
ease
d le
vels
of p
lant
toxi
cant
s or
ant
i-nut
rient
s, re
duct
ion
of im
porta
nt n
utrie
nts,
new
alle
rgen
s, o
r th
e pr
esen
ce in
the
food
or f
eed
of a
n un
appr
oved
food
/feed
add
itive
.
Appendix 8
186
Statutory Review of the Gene Technology Act 2000
Ass
essm
ent p
roce
dure
for
plac
ing
on th
e m
arke
t GM
Os
inte
nded
for
food
or
feed
(c
ontin
ued)
• F
inal
con
sulta
tions
invo
lve
the
subm
issi
on to
the
USF
DA
of a
sum
mar
y of
the
safe
ty a
nd
nutri
tiona
l ass
essm
ent t
hat h
as b
een
cond
ucte
d an
d, if
nec
essa
ry, a
mee
ting
of th
e ap
plic
ant’s
sc
ient
ists
with
FD
A s
cien
tists
to d
iscu
ss th
e da
ta a
nd re
sults
con
tain
ed in
the
subm
issi
on.
• T
he s
afet
y an
d nu
tritio
nal a
sses
smen
t sho
uld
cont
ain
info
rmat
ion
on:
the
parti
cula
rs o
f the
G
E fo
od/fe
ed a
nd p
lant
der
ivat
ive;
the
inte
nded
use
of t
he p
rodu
ct (i
nclu
ding
if it
is in
tend
ed
for f
eed
use)
; the
par
ticul
ars
of th
e in
trodu
ced
gene
tic m
ater
ial;
the
purp
ose
or in
tend
ed
tech
nica
l effe
ct o
f the
mod
ifi ca
tion;
the
mod
ifi ca
tion’
s ex
pect
ed e
ffect
on
the
com
posi
tion
or
char
acte
ristic
pro
perti
es o
f the
food
or f
eed;
the
iden
tity
and
func
tion
of e
xpre
ssio
n pr
oduc
ts
enco
ded
by th
e in
trodu
ced
gene
tic m
ater
ial,
incl
udin
g an
est
imat
e of
the
conc
entra
tion
of
any
expr
essi
on p
rodu
ct in
the
bioe
ngin
eere
d cr
op o
r der
ived
food
/feed
; alle
rgen
icity
and
to
xici
ty; t
he b
asis
for c
oncl
udin
g th
at fo
ods
cont
aini
ng th
e ex
pres
sion
pro
duct
s ca
n be
saf
ely
cons
umed
; com
parin
g th
e co
mpo
sitio
n or
cha
ract
eris
tics
of th
e bi
oeng
inee
red
food
to th
at o
f fo
od d
eriv
ed fr
om th
e pa
rent
al v
arie
ty o
r oth
er c
omm
only
con
sum
ed v
arie
ties.
• D
urin
g th
e co
nsul
tatio
n pr
oces
s, th
e U
SFD
A d
oes
not c
ondu
ct a
com
preh
ensi
ve s
cien
tifi c
re
view
of d
ata
gene
rate
d by
the
deve
lope
r. In
stea
d, th
e U
SFD
A c
onsi
ders
, bas
ed o
n ag
ency
sc
ient
ists
’ eva
luat
ion
of th
e av
aila
ble
info
rmat
ion,
whe
ther
any
unr
esol
ved
issu
es e
xist
re
gard
ing
the
food
der
ived
from
the
new
pla
nt v
arie
ty th
at w
ould
nec
essi
tate
lega
l act
ion
by
the
agen
cy if
the
prod
uct w
ere
intr
oduc
ed in
to c
omm
erce
.
• D
urin
g th
e ea
rly
cons
ulta
tion
proc
ess,
an
appl
ican
t may
sub
mit
an e
arly
food
saf
ety
eval
uatio
n. T
he e
valu
atio
n is
inte
nded
to b
e do
ne p
rior
to th
e st
age
of d
evel
opm
ent w
here
th
e ne
w p
rote
ins
mig
ht in
adve
rten
tly e
nter
the
food
sup
ply.
The
info
rmat
ion
requ
irem
ents
ar
e si
mila
r to
the
abov
e sa
fety
and
nut
ritio
nal a
sses
smen
t. A
gui
danc
e do
cum
ent o
n th
e ev
alua
tion
proc
ess
stat
es th
at th
e ev
alua
tion
is to
be
ackn
owle
dged
with
in 1
5 da
ys o
f re
ceip
t by
the
USF
DA
and
a r
espo
nse
to th
e ap
plic
ant i
s gi
ven
with
in 1
20 d
ays
of r
ecei
pt
(whi
ch is
con
side
red
shor
t). A
res
pons
e m
ay:
exte
nd th
e re
view
tim
e fo
r an
othe
r 12
0 da
ys;
requ
est f
urth
er in
form
atio
n; c
oncl
ude
that
ther
e is
no
safe
ty r
isk
and
that
it s
atisfi e
s th
e re
quir
emen
ts o
f the
Fed
eral
Foo
d, D
rug
and
Cos
met
ic A
ct.
187
and the Gene Technology Agreement
Ass
essm
ent p
roce
dure
for
plac
ing
on th
e m
arke
t GM
Os
inte
nded
for
food
or
feed
(c
ontin
ued)
• O
nce
the
cons
ulta
tion
proc
ess
has
been
com
plet
ed, t
he a
pplic
ant s
houl
d th
en s
ubm
it a
pre-
mar
ket n
otifi
catio
n. T
his
notifi
cat
ion
shou
ld b
e su
bmitt
ed to
the
USF
DA
at l
east
120
da
ys b
efor
e th
e pl
anne
d co
mm
erci
alis
atio
n da
te.
The
USF
DA
has
dra
fted
a do
cum
ent o
n th
e pr
opos
ed ru
les
for p
re-m
arke
t not
ifi ca
tion.
In
this
doc
umen
t, it
is p
ropo
sed
that
pla
nts
mod
ifi ed
to c
onta
in a
pes
ticid
e su
bsta
nce
com
e un
der t
he U
SEPA
’s ju
risdi
ctio
n vi
a th
e Fe
dera
l Ins
ectic
ide,
Fun
gici
de a
nd R
oden
ticid
e A
ct.
Food
der
ived
form
pla
nts
who
se g
enet
ic
trans
form
atio
n ha
s al
read
y be
en a
sses
sed
by th
e U
SFD
A w
ill b
e ex
empt
from
the
prop
osed
re
gula
tion.
Pro
pose
d in
form
atio
n to
be
incl
uded
in th
e no
tifi c
atio
n in
clud
es:
the
parti
cula
rs
of th
e ge
netic
mod
ifi ca
tion;
the
iden
tity
and
func
tion
of th
ese
subs
tanc
es; t
he le
vel o
f the
se
subs
tanc
es in
the
bioe
ngin
eere
d fo
od; d
ieta
ry e
xpos
ure
to th
ese
subs
tanc
es; t
he p
oten
tial t
hat
the
food
will
be
an a
llerg
en; a
nd a
dis
cuss
ion
of o
ther
saf
ety
issu
es th
at m
ay b
e as
soci
ated
w
ith th
ese
subs
tanc
es.
Info
rmat
ion,
dat
a an
d re
sults
from
ear
lier e
valu
atio
ns (s
uch
as in
the
early
food
saf
ety
eval
uatio
n) m
ay b
e su
bmitt
ed a
s pa
rt of
the
notifi
cat
ion.
Con
side
ratio
n of
eth
ical
issu
es•
No
men
tion
of e
thic
al is
sues
was
foun
d in
the
rele
vant
gui
delin
es o
r le
gisl
atio
n.
Publ
ic c
onsu
ltatio
n on
ap
plic
atio
ns•
The
app
licat
ion
for
notifi
cat
ion
will
bec
ome
publ
ic w
hen
the
USF
DA
fi le
s it,
but
ther
e w
as
no s
pecifi c
men
tion
of p
ublic
con
sulta
tion
duri
ng th
e co
nsul
tativ
e or
not
ifi ca
tion
proc
ess.
Prot
ectio
n of
con
fi den
tial
com
mer
cial
info
rmat
ion
• T
he U
SFD
A tr
eats
sub
mitt
ed in
form
atio
n in
acc
orda
nce
with
the
Uni
ted
Stat
es F
reed
om o
f In
form
atio
n A
ct, w
hich
con
tain
s pr
ovis
ions
to e
xem
pt in
form
atio
n re
late
d to
‘tra
de s
ecre
t’ an
d co
mm
erci
al in
form
atio
n. T
he p
ropo
sed
guid
elin
es a
llow
the
appl
ican
t to
subm
it tw
o ve
rsio
ns o
f the
not
ifi ca
tion:
one
has
the
info
rmat
ion
dele
ted
that
the
appl
ican
t con
side
rs
exem
pt fr
om p
ublic
dis
clos
ure.
• T
he a
pplic
atio
n fo
r no
tifi c
atio
n w
ill b
ecom
e pu
blic
whe
n th
e U
SFD
A fi
les
it. H
owev
er,
ther
e is
pro
visi
on fo
r U
SFD
A to
eva
luat
e ap
plic
ant c
laim
s fo
r co
nfi d
entia
lity
acco
rdin
g to
th
e ex
empt
ion
crite
ria
unde
r th
e pr
opos
ed n
otifi
catio
n gu
idel
ines
.
Con
ditio
ns th
at m
ay b
e ap
plie
d•
Not
app
licab
le.
Onc
e th
e G
MO
inte
nded
for
food
/feed
use
is fo
und
to b
e sa
fe fo
r hu
man
an
d an
imal
con
sum
ptio
n, it
can
be
ente
red
into
the
mar
ket w
ithou
t res
tric
tion.
Appendix 8
188
Statutory Review of the Gene Technology Act 2000
Mon
itori
ng, s
urve
illan
ce a
nd
enfo
rcem
ent p
ower
s•
If a
bio
engi
neer
ed fo
od/fe
ed is
com
mer
cial
ised
with
out p
rior
app
rova
l, th
e U
SFD
A h
as
the
pow
er u
nder
the
Fede
ral F
ood,
Dru
g an
d C
osm
etic
Act
to c
ondu
ct in
spec
tions
and
in
vest
igat
ions
, col
lect
sam
ples
and
per
form
ana
lyse
s, a
s w
ell a
s to
eng
age
in p
ublic
ity a
nd
publ
ic e
duca
tion.
• T
he F
eder
al F
ood,
Dru
g an
d C
osm
etic
Act
sta
tes
that
all
food
add
itive
s re
ceiv
e U
SFD
A
appr
oval
bef
ore
com
mer
cial
isat
ion.
Foo
ds/fe
eds
deriv
ed fr
om o
r co
ntai
ning
gen
etic
ally
en
gine
ered
pla
nts
(or
prod
ucts
ther
eof)
wou
ld b
e co
nsid
ered
as
food
/feed
add
itive
s by
the
prop
osed
not
ifi ca
tion
guid
elin
es.
Pena
lties
• T
he F
eder
al F
ood,
Dru
g an
d C
osm
etic
Act
con
tain
s pr
ovis
ions
for
pena
lties
(cri
min
al a
nd
civi
l), in
clud
ing
seiz
ure
of th
e pr
oduc
t or
proc
eeds
ther
eof.
• P
enal
ties
exis
t for
con
trav
enin
g sp
ecifi
ed s
ectio
ns o
f the
Fed
eral
Foo
d, D
rug
and
Cos
met
ic
Act
. Th
ese
may
incl
ude:
im
pris
onm
ent f
or n
ot m
ore
than
one
yea
r or
fi ne
d no
t mor
e th
an $
1000
, or
both
; im
pris
onm
ent f
or n
ot m
ore
than
thre
e ye
ars
or fi
ned
not m
ore
than
$10
,000
or
both
if a
per
son
com
mits
ano
ther
vio
latio
n w
hile
a c
onvi
ctio
n of
him
is
pend
ing,
or
the
pers
on c
omm
its a
vio
latio
n w
ith th
e in
tent
to d
efra
ud o
r m
isle
ad; a
civ
il m
oney
pen
alty
of n
ot m
ore
than
$50
,000
for
an in
divi
dual
and
$25
0,00
0 fo
r an
y ot
her
pers
on, b
ut n
ot e
xcee
ding
$50
0,00
0 fo
r al
l vio
latio
ns in
a s
ingl
e pr
ocee
ding
for
any
pers
on
who
intr
oduc
es o
r de
liver
s, fo
r co
mm
erci
alis
atio
n, a
n ar
ticle
of f
ood/
feed
with
una
ppro
ved
food
/ fee
d ad
ditiv
es (t
his
wou
ld in
clud
e ad
ditiv
es d
eriv
ed fr
om o
r th
at a
re g
enet
ical
ly
engi
neer
ed p
lant
s).
Polic
y an
d G
over
nanc
e is
sues
Liab
ility
for
cont
amin
atio
n•
The
re is
no
stri
ct li
abili
ty r
egim
e fo
r re
cove
ry b
y th
ird
part
ies;
thir
d pa
rtie
s m
ust r
ely
on th
e co
mm
on la
w o
r re
med
ies
avai
labl
e un
der
gene
ral e
nvir
onm
ent p
rote
ctio
n le
gisl
atio
n.
189
and the Gene Technology Agreement
Expe
rt c
omm
ittee
s•
Inf
orm
atio
n ab
out c
omm
ittee
s is
cur
rent
ly b
eing
cla
rifi e
d bu
t the
re a
re n
o st
atut
ory
com
mitt
ees
that
exa
min
e G
MO
s sp
ecifi
cally
.
Res
earc
h•
The
Nat
iona
l Env
iron
men
tal P
olic
y A
ct s
tate
s th
at th
e Pr
esid
ent a
ppoi
nts
mem
bers
of t
he
Cou
ncil
on E
nvir
onm
enta
l Qua
lity
and
that
par
t of i
ts r
ole
is to
res
earc
h an
d co
llect
dat
a on
the
envi
ronm
ent a
nd e
cosy
stem
s an
d m
onito
r em
ergi
ng tr
ends
, and
to h
ave
acco
unt o
f sc
ient
ifi c,
eco
nom
ic, s
ocia
l, ae
sthe
tic, a
nd c
ultu
ral n
eeds
and
inte
rest
s of
the
natio
n.
• T
here
are
gov
ernm
ent a
genc
ies
that
are
abl
e to
res
earc
h va
riou
s as
pect
s of
GM
Os.
For
exam
ple:
• T
he A
gric
ultu
ral R
esea
rch
Serv
ice
(AR
S) is
USD
A’s
in h
ouse
sci
ence
age
ncy.
The
age
ncy’
s bi
otec
hnol
ogy
rese
arch
incl
udes
intr
oduc
ing
new
trai
ts a
nd im
prov
ing
exis
ting
trai
ts in
liv
esto
ck, c
rops
, and
mic
ro-o
rgan
ism
s; s
afeg
uard
ing
the
envi
ronm
ent;
and
asse
ssin
g an
d en
hanc
ing
the
safe
ty o
f bio
tech
nolo
gy p
rodu
cts.
• T
he C
oope
rativ
e St
ate
Res
earc
h, E
duca
tion,
and
Ext
ensi
on S
ervi
ce (C
SREE
S) a
dmin
iste
rs
the
Bio
tech
nolo
gy R
isk
Ass
essm
ent R
esea
rch
Gra
nts
Prog
ram
(BR
AG
) whi
ch s
uppo
rts
the
deve
lopm
ent o
f sci
ence
-bas
ed in
form
atio
n re
gard
ing
the
safe
ty o
f int
rodu
cing
into
the
envi
ronm
ent g
enet
ical
ly-m
odifi
ed p
lant
s, a
nim
als,
and
mic
ro-o
rgan
ism
s.
Oth
er
Liab
ility
for
cont
amin
atio
n•
No
refe
renc
e to
a s
tric
t lia
bilit
y re
gim
e or
no-
faul
t sch
eme
was
foun
d.
The
prec
autio
nary
pri
ncip
le•
The
legi
slat
ion
does
not
ref
eren
ce th
e pr
ecau
tiona
ry p
rinc
iple
.
Appendix 8
190
Statutory Review of the Gene Technology Act 2000
Cos
t rec
over
y•
The
re is
cap
acity
for
som
e co
st r
ecov
ery:
for
exam
ple,
per
mit
appl
icat
ions
car
ry a
cha
rge
but t
he s
ervi
ces
of in
spec
tors
dur
ing
regu
lar
assi
gned
hou
rs a
nd a
t usu
al p
lace
s of
dut
y ar
e fu
rnis
hed
with
out c
ost,
whe
reas
ove
rtim
e fo
r in
spec
tors
doe
s ca
rry
a co
st.
Mor
ator
ium
• N
o m
orat
oriu
m.
Oth
erTh
e pr
e-m
arke
t not
ifi ca
tion
guid
elin
es w
ere
mad
e in
200
1 an
d at
the
time
of c
ompi
ling
this
in
form
atio
n, it
did
not
app
ear
that
the
guid
elin
es h
ad b
een
enac
ted
into
legi
slat
ion.
191
and the Gene Technology Agreement
RE
GU
LA
TIO
N O
F G
EN
E T
EC
HN
OL
OG
Y I
N C
AN
AD
A
SUM
MA
RY —
Can
ada
does
not
hav
e a
sing
le p
iece
of l
egis
latio
n th
at r
egul
ates
GM
Os.
Mos
t of t
he le
gisl
atio
n ap
plic
able
to
bio
tech
nolo
gy a
ddre
sses
spe
cifi c
pro
duct
cat
egor
ies,
and
per
tain
s bo
th to
bio
logi
cal a
nd n
on-b
iolo
gica
l pro
cess
es a
nd
prod
ucts
.
• T
he m
ain
agen
cies
invo
lved
in th
e re
gula
tion
of G
MO
s ar
e A
gric
ultu
re a
nd A
gri-
Food
Can
ada,
Env
iron
men
t Can
ada
and
Hea
lth a
nd W
elfa
re C
anad
a. T
he r
elev
ant l
egis
latio
n in
clud
es:
Can
adia
n En
viro
nmen
t Pro
tect
ion
Act
199
9 (C
EPA
) (c
over
s th
ose
uses
not
cov
ered
by
othe
r le
gisl
atio
n); F
eeds
Act
(fee
ds);
Fert
ilise
rs A
ct (s
uppl
emen
ts);
Hea
lth o
f Ani
mal
s A
ct (v
eter
inar
y bi
olog
ics)
; See
ds A
ct (p
lant
s w
ith n
ovel
trai
ts);
Pest
Con
trol
Pro
duct
s A
ct (m
icro
bial
pes
t con
trol
age
nts)
; an
d Fo
od a
nd D
rugs
Act
(dru
gs, c
osm
etic
s, m
edic
al d
evic
es, a
nd n
ovel
food
s fr
om b
oth
plan
t and
ani
mal
sou
rces
); Pl
ant
Prot
ectio
n A
ct (i
mpo
rtat
ion
of u
napp
rove
d pl
ants
with
nov
el tr
aits
).
• T
he r
elea
se o
f nov
el s
ubst
ance
s (th
is in
clud
es G
MO
s) in
to th
e en
viro
nmen
t is
gove
rned
by
the
abov
e-m
entio
ned
Act
s.
Ther
e ar
e al
so d
irec
tives
that
pro
vide
gui
delin
es fo
r ap
plyi
ng fo
r th
e re
leas
e of
nov
el s
ubst
ance
s in
to th
e en
viro
nmen
t. In
ad
ditio
n, th
ere
are
dire
ctiv
es fo
r th
e re
leas
e of
nov
el p
lant
and
ani
mal
org
anis
ms
for
both
con
fi ned
and
unc
onfi n
ed r
elea
ses.
Th
e C
anad
ian
Food
Insp
ectio
n A
genc
y, u
nder
the
Agr
icul
ture
and
Agr
i-Fo
od P
ortfo
lio, i
s th
e m
ain
agen
cy r
espo
nsib
le fo
r th
e re
leas
e of
nov
el s
ubst
ance
into
the
envi
ronm
ent a
nd is
div
ided
into
Sec
tions
. O
ne o
f the
sec
tions
, the
Pla
nt B
iosa
fety
O
ffi ce
has
car
riag
e of
ass
essi
ng a
pplic
atio
ns fo
r th
e co
nfi n
ed a
nd u
ncon
fi ned
rel
ease
of n
ovel
sub
stan
ces
(pla
nt) i
nto
the
envi
ronm
ent.
If th
e no
vel p
lant
s co
uld
be u
sed
as a
feed
(for
live
stoc
k or
labo
rato
ry a
nim
als)
, the
n th
e Fe
ed S
ectio
n of
the
Can
adia
n Fo
od In
spec
tion
Age
ncy
asse
sses
the
appl
icat
ion
for
rele
ase.
App
licat
ions
for
rele
ase
of n
ovel
sub
stan
ces
that
co
uld
be u
sed
as fo
od fo
r hu
man
s ar
e as
sess
ed b
y th
e D
epar
tmen
t of H
ealth
. W
here
nec
essa
ry, a
ppro
val f
or r
elea
se o
f a
nove
l sub
stan
ce m
ay r
equi
re a
ppro
val f
rom
mor
e th
an o
ne a
utho
rity
/age
ncy.
192
Statutory Review of the Gene Technology Act 2000
Con
tain
ed w
ork
wit
h G
MO
s
Res
pons
ible
age
ncy
• C
anad
ian
Med
ical
Res
earc
h C
ounc
il.
• G
uide
lines
of t
he U
nite
d St
ates
of A
mer
ica’
s N
atio
nal I
nstit
ute
of H
ealth
(NIH
).
Legi
slat
ion
• C
onta
ined
res
earc
h in
volv
ing
GM
Os
is n
ot c
over
ed b
y C
EPA
.
• L
abor
ator
y re
sear
ch in
Can
ada
is c
over
ed b
y th
e U
S N
IH’s
Gui
delin
es fo
r R
esea
rch
Invo
lvin
g R
ecom
bina
nt D
NA
Mol
ecul
es.
All
scie
ntis
ts w
orki
ng w
ith G
MO
s m
ust a
dher
e to
the
guid
elin
es
esta
blis
hed
by th
e M
edic
al R
esea
rch
Cou
ncil,
as
wel
l as
code
s of
pra
ctic
e es
tabl
ishe
d by
thei
r ow
n in
stitu
tion.
Inte
ntio
nal r
elea
ses
of G
MO
s in
the
env
iron
men
t
Res
pons
ible
age
ncy
• E
nvir
onm
ent C
anad
a.
Legi
slat
ion
• C
EPA
.
• D
irec
tive
2000
–07:
Con
duct
ing
Con
fi ned
Res
earc
h Fi
eld
Tria
ls o
f Pla
nts
with
Nov
el T
raits
in
Can
ada.
• S
eeds
Act
and
am
endm
ents
.
• D
irec
tive
95–0
3: G
uide
lines
for
the
Ass
essm
ent o
f Nov
el F
eeds
: Pl
ant S
ourc
es.
• F
eeds
Act
and
am
endm
ents
.
• D
irec
tive
94–0
8: A
sses
smen
t Cri
teri
a fo
r D
eter
min
ing
Envi
ronm
enta
l Saf
ety
of P
lant
s W
ith N
ovel
Tr
aits
.
Cov
erag
e of
the
legi
slat
ion
• S
ubst
ance
s th
at a
re n
ew (i
.e. n
ot o
n th
e lis
t of D
omes
tic S
ubst
ance
s) c
anno
t be
man
ufac
ture
d or
im
port
ed u
nles
s ap
prov
al is
gra
nted
from
the
Min
iste
r.
193
and the Gene Technology Agreement
Cov
erag
e of
th
e le
gisl
atio
n (c
ontin
ued)
• S
ubst
ance
is d
efi n
ed a
s an
y di
stin
guis
habl
e ki
nd o
f org
anic
or
inor
gani
c m
atte
r, w
heth
er a
nim
ate
or
inan
imat
e, a
nd in
clud
es a
ny m
atte
r th
at is
cap
able
of b
eing
dis
pers
ed in
the
envi
ronm
ent o
r of
bei
ng
tran
sfor
med
in th
e en
viro
nmen
t int
o m
atte
r th
at is
cap
able
of b
eing
so
disp
erse
d or
that
is c
apab
le o
f ca
usin
g su
ch tr
ansf
orm
atio
n in
the
envi
ronm
ent.
‘Liv
ing
orga
nism
’ is
defi n
ed a
s a
subs
tanc
e th
at is
an
ani
mat
e pr
oduc
t of b
iote
chno
logy
.
• Th
e C
anad
ian
Food
Insp
ectio
n A
genc
y’s
Plan
t Bio
safe
ty O
ffi ce
is re
spon
sibl
e fo
r reg
ulat
ing
the
inte
ntio
nal
intro
duct
ion
into
the
envi
ronm
ent i
n C
anad
a of
pla
nts
with
nov
el tr
aits
(PN
Ts).
The
pro
cedu
res
and
guid
elin
es fo
r app
lyin
g to
rele
ase
PNTs
into
the
envi
ronm
ent a
re o
utlin
ed in
Dire
ctiv
e 20
00–0
7.
• T
he F
eeds
Act
gov
erns
the
use
of fe
ed w
ithin
Can
ada
and
ensu
res
that
it is
saf
e to
use
. N
ovel
feed
s,
incl
udin
g th
ose
with
a n
ovel
trai
t req
uire
a n
otifi
catio
n of
inte
nded
rele
ase
to b
e ap
prov
ed b
y th
e re
leva
nt m
inis
ter b
efor
e th
ey c
an b
e re
leas
ed.
The
Act
and
its
Reg
ulat
ions
refe
r to
the
rele
ase
of n
ovel
fe
eds,
incl
udin
g th
ose
with
nov
el tr
aits
, for
rese
arch
pur
pose
s on
ly.
• D
irec
tive
95-0
3 ap
plie
s to
nov
el fe
eds
from
pla
nts,
or
part
s or
pro
duct
s th
ereo
f, th
at h
ave
not b
een
prev
ious
ly u
sed
as li
vest
ock
feed
in C
anad
a, a
nd/o
r ha
ve a
nov
el tr
ait.
The
app
licat
ion
requ
ires
in
form
atio
n on
the
nove
l tra
it, te
chni
ques
use
d, th
e br
eedi
ng h
isto
ry, n
utri
tiona
l dat
a, to
xico
logy
dat
a an
d di
etar
y ex
posu
re, a
llerg
y da
ta, a
nim
al/li
vest
ock
tria
l dat
a, a
n en
viro
nmen
tal r
isk
asse
ssm
ent,
dete
ctio
n m
etho
ds.
The
guid
elin
es a
ppea
r as
thou
gh th
ey c
an b
e us
ed fo
r ap
plyi
ng fo
r re
leas
e of
no
vel f
eed
(pla
nt s
ourc
e) fo
r ev
entu
al c
omm
erci
alis
atio
n.
Ass
essm
ent p
roce
ss
for
confi
ned
in
tent
iona
l rel
ease
s of
a G
MO
into
the
envi
ronm
ent (fi e
ld
tria
ls),
incl
udin
g fo
r ex
peri
men
ts o
n G
MO
s in
tend
ed fo
r fe
ed
• T
he M
inis
ter
mus
t be
notifi
ed
if so
meo
ne w
ishe
s to
man
ufac
ture
or
impo
rt a
new
sub
stan
ce th
at is
no
t on
the
Dom
estic
Sub
stan
ces
List
(if i
t is
on th
e lis
t no
appr
oval
is n
eces
sary
).
• I
nfor
mat
ion
rele
vant
to th
e as
sess
men
t mus
t be
prov
ided
to th
e M
inis
ter.
• A
ll pr
opos
als
unde
rgo
a si
ngle
60-
day
publ
ic c
onsu
ltatio
n pe
riod
whe
re in
tere
sted
par
ties
may
bri
ng
forw
ard
addi
tiona
l sci
entifi
c e
vide
nce
to s
uppo
rt o
r re
fute
the
Min
iste
r’s d
ecis
ion.
• A
fter
taki
ng in
to a
ccou
nt a
ny a
dvic
e pr
ovid
ed, t
he M
inis
ter
mus
t dec
ide
whe
ther
the
subs
tanc
e is
to
xic
or c
apab
le o
f bec
omin
g to
xic.
Appendix 8
194
Statutory Review of the Gene Technology Act 2000
Ass
essm
ent p
roce
ss
for
confi
ned
in
tent
iona
l rel
ease
s of
a G
MO
into
the
envi
ronm
ent (fi e
ld
tria
ls),
incl
udin
g fo
r ex
peri
men
ts o
n G
MO
s in
tend
ed fo
r fe
ed (c
ontin
ued)
• I
f the
Min
iste
r dec
ides
that
the
orga
nism
is n
ot to
xic
or c
apab
le o
f bec
omin
g to
xic,
the
Min
iste
r can
pl
ace
the
orga
nism
on
the
Dom
estic
Sub
stan
ce R
egis
ter b
ut c
anno
t im
pose
any
con
ditio
ns.
• I
f the
Min
iste
r de
cide
s th
at th
e or
gani
sm is
toxi
c or
cap
able
of b
ecom
ing
toxi
c, th
en th
e M
inis
ter
can:
(a) p
erm
it its
man
ufac
ture
or
impo
rtat
ion
subj
ect t
o an
y co
nditi
ons
the
Min
iste
r m
ay s
peci
fy; o
r (b
) can
pro
hibi
t its
impo
rt o
r m
anuf
actu
re.
• T
he fi
nal d
ecis
ion
of th
e M
inis
ter
mus
t be
publ
ishe
d.
• U
nder
Dir
ectiv
e 20
00–0
7 (w
hich
pro
vide
s gu
idel
ines
to th
e ap
plic
ant o
n ho
w to
app
ly fo
r th
e co
nfi n
ed r
elea
se o
f a P
NT)
the
appl
icat
ion
for
a co
nfi n
ed r
esea
rch fi e
ld tr
ial:
put
s th
e on
us o
n th
e ap
plic
ant t
o en
sure
that
the
PNT
will
not
neg
ativ
ely
affe
ct a
ny o
ther
tria
l or
non-
PNT
crop
s;
requ
ires
the
appl
ican
t to
cons
ider
con
tinge
ncy
plan
s in
the
even
t of a
ccid
enta
l rel
ease
of m
ater
ial
or in
adve
rten
t bre
akdo
wn
of r
epro
duct
ive
isol
atio
n. I
f the
app
lican
t int
ends
on
feed
ing
the
mat
eria
l fr
om th
e co
nfi n
ed r
esea
rch fi e
ld tr
ial t
o liv
esto
ck fo
r re
sear
ch p
urpo
ses,
the
appl
icat
ion
is g
iven
to
the
Feed
Sec
tion
of th
e C
anad
ian
Food
Insp
ectio
n A
genc
y. T
he a
pplic
atio
ns a
re s
ent t
o pr
ovin
cial
go
vern
men
ts w
here
the
tria
ls w
ill o
ccur
, who
then
hav
e 30
day
s to
pro
vide
com
men
t. T
he
com
men
ts a
re c
onsi
dere
d by
the
Plan
t Bio
safe
ty O
ffi ce
whe
n m
akin
g a
deci
sion
on
the
appl
icat
ion.
To
ens
ure
that
the
tria
ls a
re fo
r re
sear
ch p
urpo
ses
only
: ea
ch tr
ial s
ite m
ust b
e no
larg
er th
an 1
Ha;
th
ere
are
no m
ore
than
10
tria
l site
s pe
r su
bmis
sion
, per
pro
vinc
e; tr
ial s
ite lo
catio
ns a
re n
o la
rger
th
an 5
Ha
cum
ulat
ive
per
subm
issi
on, p
er p
rovi
nce.
The
app
lican
t is
resp
onsi
ble
for
repr
oduc
tive
isol
atio
n or
oth
er is
olat
ion
met
hods
(suc
h as
bag
s an
d ne
ts o
ver fl o
wer
ing
plan
t par
ts, h
arve
st o
f pl
ant b
efor
e fl o
wer
ing,
rem
oval
of fl
ow
ers
befo
re p
olle
n m
atur
ity).
195
and the Gene Technology Agreement
Ass
essm
ent p
roce
ss
for
confi
ned
in
tent
iona
l rel
ease
s of
a G
MO
into
the
envi
ronm
ent (fi e
ld
tria
ls),
incl
udin
g fo
r ex
peri
men
ts o
n G
MO
s in
tend
ed fo
r fe
ed (c
ontin
ued)
• U
nder
the
Feed
s A
ct a
nd it
s am
endm
ents
and
reg
ulat
ions
a w
ritte
n no
tifi c
atio
n of
the
prop
osed
re
leas
e m
ust b
e m
ade
to th
e M
inis
ter,
incl
udin
g in
form
atio
n su
ch a
s: t
he p
artic
ular
s of
the
rele
ase;
co
nfi n
emen
t and
mon
itori
ng p
roce
dure
s; m
etho
ds fo
r sa
fe d
ispo
sal;
cont
inge
ncy
plan
s to
miti
gate
ad
vers
e ef
fect
s on
hum
ans
and
the
envi
ronm
ent i
n th
e ev
ent o
f acc
iden
tal r
elea
se; t
he p
artic
ular
s of
th
e no
vel t
rait;
any
res
ults
from
dat
a or
res
earc
h do
ne to
iden
tify
risk
s to
the
envi
ronm
ent o
r hu
man
he
alth
. Th
e M
inis
ter
for A
gric
ultu
re a
nd A
gri-
food
s ca
n th
en e
ither
aut
hori
se o
r re
fuse
to a
utho
rise
th
e re
leas
e of
the
nove
l fee
d an
d sh
all c
onsi
der
the
mag
nitu
de o
f exp
osur
e of
the
rele
ase,
the
effe
cts
on th
e en
viro
nmen
t and
whe
ther
the
nove
l fee
d is
toxi
c. T
he a
pplic
atio
n sh
all b
e ac
com
pani
ed w
ith
evid
ence
(suc
h as
sci
entifi
c r
esea
rch)
to p
erm
it an
ass
essm
ent o
r ev
alua
tion
of th
e sa
fety
and
effi
cacy
of
the
feed
in r
espe
ct o
f liv
esto
ck a
nd it
s po
tent
ial e
ffect
on
hum
ans
and
on th
e en
viro
nmen
t.
• D
irect
ive
95-0
3 pr
ovid
es th
e gu
idel
ines
for t
he c
ompl
etio
n of
an
appl
icat
ion
for t
he u
ncon
fi ned
rel
ease
of
a n
ovel
feed
from
pla
nt s
ourc
es. A
pplic
atio
ns s
houl
d co
ntai
n: s
uffi c
ient
dat
a ab
out t
he n
ovel
trai
t; in
form
atio
n ab
out t
he m
odifi
catio
n hi
stor
y; c
hara
cter
isat
ion
of th
e D
NA
inse
rted,
if a
ny; n
utrit
iona
l da
ta, a
llerg
enic
ity d
ata;
toxi
colo
gy d
ata;
die
tary
exp
osur
e; la
bora
tory
ani
mal
/live
stoc
k fe
edin
g tri
al
data
; env
ironm
enta
l ris
k as
sess
men
t; m
etho
d of
det
ectio
n. A
dec
isio
n is
then
mad
e on
the
info
rmat
ion
prov
ided
in th
e ap
plic
atio
n.
• Th
e ap
plic
atio
n pr
oced
ure
and
info
rmat
ion
requ
irem
ents
for r
elea
sing
of a
nov
el fe
ed o
f an
anim
al o
rigin
is
sim
ilar t
o th
at fo
r a n
ovel
feed
from
a p
lant
sou
rce
and
is o
utlin
ed in
the
Feed
s Act
and
regu
latio
ns.
• T
here
is a
dra
ft do
cum
ent t
hat o
utlin
es th
e ap
plic
atio
n re
quire
men
ts fo
r not
ifi ca
tion
of a
rele
ase
of
biot
echn
olog
y-de
rived
live
stoc
k an
imal
s. T
his
draf
t app
ears
to a
pply
to c
onfi n
ed a
nd u
ncon
fi ned
re
leas
es.
Info
rmat
ion
requ
irem
ents
incl
ude
info
rmat
ion:
on
the
orga
nism
; on
the
orga
nism
’s m
anuf
actu
re o
r im
port;
on
the
intro
duct
ion
of th
e or
gani
sm; o
n th
e en
viro
nmen
tal f
ate
of th
e or
gani
sm;
on th
e or
gani
sm’s
envi
ronm
enta
l effe
cts;
on
pote
ntia
l adv
erse
effe
cts
on h
uman
hea
lth; o
n te
st d
ata
that
as
sist
s in
the
iden
tifi c
atio
n of
haz
ards
to h
uman
hea
lth a
nd e
nviro
nmen
t. If
the
orga
nism
is c
onfi n
ed,
info
rmat
ion
on th
e po
ssib
le m
echa
nism
s fo
r esc
ape
and
poss
ible
dis
pers
al is
als
o re
quire
d.
Appendix 8
196
Statutory Review of the Gene Technology Act 2000
Con
side
ratio
n of
et
hica
l iss
ues
• I
n m
akin
g a
deci
sion
Min
iste
rs m
ay o
nly
dete
rmin
e w
heth
er th
e su
bsta
nce
is to
xic
or c
apab
le
of b
ecom
ing
toxi
c. N
o sp
ecifi
c m
entio
n of
eth
ics
or tr
ade
is m
ade.
How
ever
, the
Min
iste
r m
ay
take
into
acc
ount
fact
ors
such
as,
but
not
lim
ited
to s
ocia
l, ec
onom
ic a
nd te
chni
cal m
atte
rs
whe
n de
term
inin
g pr
even
tativ
e or
con
trol
act
ion
in r
elat
ion
to a
sub
stan
ce o
r in
pla
ns fo
r vi
rtua
l el
imin
atio
n of
the
subs
tanc
e.
Publ
ic c
onsu
ltatio
n on
app
licat
ions
• A
ll pr
opos
als
for
rele
ase
of a
GM
O in
to th
e en
viro
nmen
t und
ergo
a s
ingl
e 60
-day
pub
lic
cons
ulta
tion
peri
od w
here
inte
rest
ed p
artie
s m
ay b
ring
forw
ard
addi
tiona
l sci
entifi
c e
vide
nce
to
supp
ort o
r re
fute
the
Min
iste
r’s d
ecis
ion.
Prot
ectio
n of
co
nfi d
entia
l co
mm
erci
al
info
rmat
ion
• A
n ap
plic
ant m
ay r
eque
st th
at in
form
atio
n be
trea
ted
as c
onfi d
entia
l.
• T
he M
inis
ter
mus
t not
dis
clos
e an
y in
form
atio
n in
res
pect
of w
hich
a r
eque
st fo
r co
nfi d
entia
lity
has
been
mad
e un
less
: it
is in
the
publ
ic in
tere
st; o
r it
is d
iscl
osed
und
er a
n ag
reem
ent b
etw
een
the
Gov
ernm
ent o
f Can
ada
and
any
othe
r go
vern
men
t of C
anad
a or
gov
ernm
ent o
f a fo
reig
n st
ate
etc,
an
d th
e ag
ency
agr
ees
to k
eep
the
info
rmat
ion
confi
den
tial.
Con
ditio
ns th
at m
ay
be a
pplie
d•
Whe
re th
e M
inis
ter
susp
ects
that
a li
ving
org
anis
m is
toxi
c or
cap
able
of b
eing
toxi
c, th
e M
inis
ter
for
the
Envi
ronm
ent m
ay p
erm
it th
e m
anuf
actu
re o
r im
port
of t
he li
ving
org
anis
ms
subj
ect t
o an
y co
nditi
ons
that
the
Min
iste
r m
ay s
peci
fy.
Mon
itori
ng,
surv
eilla
nce
and
enfo
rcem
ent p
ower
s
• E
nfor
cem
ent o
ffi ce
rs m
ay b
e ap
poin
ted
unde
r th
e C
EPA
.
• E
nfor
cem
ent o
ffi ce
rs h
ave
the
pow
er to
ent
er a
nd in
spec
t pre
mis
es w
here
a s
ubst
ance
can
be
foun
d,
for
the
purp
oses
of t
he A
ct. O
ffi ce
rs h
ave
been
giv
en w
ide
pow
ers
of in
spec
tion,
incl
udin
g op
enin
g re
cept
acle
s an
d pa
ckag
es, e
xam
inin
g re
cord
s, ta
king
sam
ples
and
con
duct
ing
test
s. C
EPA
als
o al
low
s offi c
ers
to a
ct w
ithou
t war
rant
s in
em
erge
ncie
s. O
ffi ce
rs m
ay s
eize
or
deta
in a
nyth
ing
whi
ch
caus
ed a
con
trav
entio
n to
occ
ur, o
r w
hich
will
pro
vide
evi
denc
e of
the
cont
rave
ntio
n; h
owev
er, t
hey
can
only
do
so if
it is
req
uire
d fo
r ev
iden
ce, a
naly
sis
or it
is in
the
publ
ic in
tere
st to
do
so.
197
and the Gene Technology Agreement
Mon
itori
ng,
surv
eilla
nce
and
enfo
rcem
ent p
ower
s (c
ontin
ued)
• O
ffi ce
rs m
ay a
lso
issu
e en
viro
nmen
tal p
rote
ctio
n co
mpl
ianc
e or
ders
to o
wne
rs a
nd m
anag
ers
and
pers
ons
cont
ribu
ting
to c
ontr
aven
tions
whi
ch m
ust b
e co
mpl
ied
with
(ord
ers
can
incl
ude
repo
rtin
g re
quir
emen
ts, a
nd to
cea
se o
pera
ting)
.
• U
nder
Dir
ectiv
e 20
00-0
7, th
e C
anad
ian
Food
Insp
ectio
n A
genc
y re
quir
es th
e ap
plic
ant t
o ke
ep
reco
rds
rega
rdin
g th
e m
anag
emen
t of t
he s
ite (i
nclu
ding
mon
itori
ng, h
arve
stin
g, c
lean
ing
of
harv
estin
g m
achi
nery
, tra
nspo
rtat
ion
and
stor
age
of th
e pl
ant m
ater
ial)
and
the
reco
rds
mus
t be
mad
e av
aila
ble
upon
req
uest
. Reg
iona
l Foo
d In
spec
tion
offi c
ers
have
the
pow
er to
insp
ect t
rial
site
s du
ring
th
e gr
owin
g se
ason
at r
ando
m a
nd w
ithou
t not
ifi ca
tion.
• U
nder
the
Feed
s A
ct a
nd S
eeds
Act
, the
re a
re p
rovi
sion
s fo
r in
spec
tions
and
insp
ecto
rs to
sei
ze a
nd
deta
in a
rtic
les,
ope
n pa
ckag
es a
nd ta
ke s
ampl
es, w
here
an
insp
ecto
r be
lieve
s on
rea
sona
ble
grou
nds
that
the
Act
or
the
regu
latio
ns h
ave
been
con
trav
ened
.
Pena
lties
• A
max
imum
fi ne
of C
A$1
,000
,000
or
a pr
ison
term
of 3
yea
rs e
xist
s (if
con
vict
ed o
n in
dict
men
t) fo
r pe
rson
s w
ho c
ontr
aven
e a
prov
isio
n of
the
Act
or
regu
latio
ns, a
n or
der
or d
irec
tion
unde
r th
e A
ct o
r an
obl
igat
ion
or a
pro
hibi
tion
aris
ing
from
the
Act
or
regu
latio
ns, o
r w
ho k
now
ingl
y pr
ovid
e fa
lse
or
mis
lead
ing
info
rmat
ion.
• F
or s
umm
ary
conv
ictio
n it
is C
A$3
00,0
00 o
r 6
mon
ths.
• I
f, in
com
mitt
ing
the
offe
nce,
a p
erso
n in
tent
iona
lly o
r re
ckle
ssly
cau
ses
a di
sast
er th
at r
esul
ts in
loss
of
the
use
of th
e en
viro
nmen
t, or
sho
ws
wan
ton
disr
egar
d fo
r th
e liv
es o
r sa
fety
of o
ther
per
sons
and
th
ereb
y ca
uses
a r
isk
of d
eath
or
harm
to a
noth
er p
erso
n, th
e m
axim
um p
riso
n te
rm in
crea
ses
to 5
ye
ars
and
ther
e ca
n be
an
unlim
ited fi n
e im
pose
d.
• E
ach
day
the
offe
nce
is c
omm
itted
is a
sep
arat
e of
fenc
e. T
he C
EPA
als
o se
ts d
own
crite
ria
whi
ch
the
Cou
rt m
ust l
ook
at w
hen
sent
enci
ng, i
nclu
ding
har
m c
ause
d, th
e co
sts
of a
ny r
emed
ial a
ctio
ns,
inte
ntio
n, a
nd a
ny p
rope
rty,
ben
efi t
or a
dvan
tage
to th
e of
fend
er.
Appendix 8
198
Statutory Review of the Gene Technology Act 2000
Pena
lties
(con
tinue
d)•
Des
pite
the
max
imum
am
ount
of a
ny fi
ne u
nder
the
legi
slat
ion,
a c
ourt
may
impo
se a
n ad
ditio
nal
fi ne
equa
l to
the
cour
t’s e
stim
atio
n of
the
amou
nt o
f pro
pert
y, b
enefi
t or
adv
anta
ge d
eriv
ed b
y th
e of
fend
er fr
om th
eir
actio
ns. I
nste
ad o
f con
vict
ing
an o
ffend
er, o
r in
add
ition
to o
ther
pun
ishm
ents
, a
cour
t may
mak
e an
ord
er r
equi
ring
the
offe
nder
to d
o or
ref
rain
from
doi
ng c
erta
in a
ctio
n (e
.g.
requ
irin
g th
e of
fend
er to
take
any
act
ion
to r
emed
y or
avo
id h
arm
, pre
pare
and
impl
emen
t a
pollu
tion
prev
entio
n pl
an, c
arry
out
env
iron
men
tal e
ffect
s m
onito
ring
, com
pens
ate
the
Min
iste
r, pa
y an
am
ount
to e
nvir
onm
enta
l, he
alth
or
othe
r gr
oups
or
to s
chol
arsh
ips
for
stud
ents
enr
olle
d in
en
viro
nmen
tal s
tudi
es, o
r pu
blis
h th
e fa
cts
rela
ting
to th
e in
cide
nt).
• P
enal
ties
for
cont
rave
ning
the
Feed
s A
ct o
r th
e Se
eds
Act
incl
ude:
a fi
ne o
f up
to C
A$5
0,00
0 or
six
m
onth
s im
pris
onm
ent o
r bo
th fo
r an
offe
nce
puni
shab
le b
y su
mm
ary
conv
ictio
n; a
fi ne
of u
p to
C
A$2
50,0
00 o
r tw
o ye
ars
impr
ison
men
t or
both
.
Plac
ing
GM
Os
(or
prod
ucts
con
tain
ing
GM
Os)
on
the
mar
ket
Res
pons
ible
age
ncy
• E
nvir
onm
ent C
anad
a.
• T
he C
anad
ian
Food
Insp
ectio
n A
genc
y’s
Plan
t Bio
safe
ty O
ffi ce
is r
espo
nsib
le fo
r re
gula
ting
the
inte
ntio
nal i
ntro
duct
ion
into
the
envi
ronm
ent i
n C
anad
a of
pla
nts
with
nov
el tr
aits
(PN
Ts).
Legi
slat
ion
• F
eeds
Act
and
am
endm
ents
.
• D
irec
tive
94-0
8: A
sses
smen
t Cri
teri
a fo
r D
eter
min
ing
Envi
ronm
enta
l Saf
ety
of P
lant
s W
ith N
ovel
Tr
aits
.
Cov
erag
e of
the
legi
slat
ion
• D
irec
tive
94-0
8 pr
ovid
es g
uida
nce
rega
rdin
g th
e su
bmis
sion
of a
n ap
plic
atio
n fo
r th
e au
thor
isat
ion
of th
e un
confi
ned
rel
ease
of a
PN
T. A
n un
confi
ned
rel
ease
invo
lves
the
rele
ase
of a
PN
T in
to th
e en
viro
nmen
t with
no
rest
rict
ions
, with
a v
iew
tow
ards
com
mer
cial
isat
ion.
199
and the Gene Technology Agreement
App
licat
ion
proc
ess
for
unco
nfi n
ed r
elea
se
of G
MO
s in
to
the
envi
ronm
ent
(usu
ally
for
the
purp
ose
of
com
mer
cial
isat
ion)
• T
he M
inis
ter
mus
t be
notifi
ed
if so
meo
ne w
ishe
s to
man
ufac
ture
or
impo
rt a
new
sub
stan
ce th
at is
no
t on
the
Dom
estic
Sub
stan
ces
List
(if i
t is
on th
e lis
t no
appr
oval
is n
eces
sary
).
• I
nfor
mat
ion
rele
vant
to th
e as
sess
men
t mus
t be
prov
ided
to th
e M
inis
ter.
• A
ll pr
opos
als
unde
rgo
a si
ngle
60-
day
publ
ic c
onsu
ltatio
n pe
riod
whe
re in
tere
sted
par
ties
may
bri
ng
forw
ard
addi
tiona
l sci
entifi
c e
vide
nce
to s
uppo
rt o
r re
fute
the
Min
iste
r’s d
ecis
ion.
• A
fter
taki
ng in
to a
ccou
nt a
ny a
dvic
e pr
ovid
ed, t
he M
inis
ter
mus
t dec
ide
whe
ther
the
subs
tanc
e is
to
xic
or c
apab
le o
f bec
omin
g to
xic.
• I
f the
Min
iste
r dec
ides
that
the
orga
nism
is n
ot to
xic
or c
apab
le o
f bec
omin
g to
xic,
the
Min
iste
r can
pl
ace
the
orga
nism
on
the
Dom
estic
Sub
stan
ce R
egis
ter b
ut c
anno
t im
pose
any
con
ditio
ns.
• I
f the
Min
iste
r de
cide
s th
at th
e or
gani
sm is
toxi
c or
cap
able
of b
ecom
ing
toxi
c, th
en th
e M
inis
ter
can:
(a) p
erm
it its
man
ufac
ture
or
impo
rtat
ion
subj
ect t
o an
y co
nditi
ons
the
Min
iste
r m
ay s
peci
fy; o
r (b
) can
pro
hibi
t its
impo
rt o
r m
anuf
actu
re.
• T
he fi
nal d
ecis
ion
of th
e M
inis
ter
mus
t be
publ
ishe
d.
• D
irec
tive
94-0
8 sp
ecifi
es th
at a
pplic
atio
ns c
onta
in in
form
atio
n th
at a
llow
s th
e Pl
ant B
iosa
fety
Offi
ce
to c
ondu
ct a
n en
viro
nmen
tal r
isk
asse
ssm
ent.
• T
he c
rite
ria
for
the
asse
ssm
ent i
nclu
de:
pote
ntia
l of t
he P
NT
to b
ecom
e a
wee
d of
agr
icul
ture
or
be in
vasi
ve o
f nat
ural
hab
itats
; pot
entia
l for
gen
e-fl o
w to
wild
rel
ativ
es w
hose
hyb
rid
offs
prin
g m
ay
beco
me
mor
e w
eedy
or
mor
e in
vasi
ve; p
oten
tial f
or th
e PN
T to
bec
ome
a pl
ant p
est;
pote
ntia
l im
pact
of t
he P
NT
or it
s ge
ne p
rodu
cts
on n
on-t
arge
t spe
cies
, inc
ludi
ng h
uman
s; p
oten
tial i
mpa
ct
on b
iodi
vers
ity. I
n co
nsid
erin
g th
e en
viro
nmen
tal s
afet
y, th
e Pl
ant B
iosa
fety
Offi
ce m
ay c
onsu
lt w
ith
scie
ntifi
c ex
pert
s.
Appendix 8
200
Statutory Review of the Gene Technology Act 2000
App
licat
ion
proc
ess
for
unco
nfi n
ed r
elea
se
of G
MO
s in
to
the
envi
ronm
ent
(usu
ally
for
the
purp
ose
of
com
mer
cial
isat
ion)
(c
ontin
ued)
• I
n ad
ditio
n, a
nd b
efor
e au
thor
isat
ion
for
rele
ase
can
be g
rant
ed, i
nfor
mat
ion
on th
e fo
llow
ing
is a
lso
requ
ired
: th
e id
entit
y an
d or
igin
of t
he P
NT;
the
prop
ertie
s of
the
nove
l gen
e an
d ge
ne p
rodu
cts;
the
rela
tive
phen
otyp
ic e
xpre
ssio
n of
the
PNT
com
pare
d to
a s
imila
r co
unte
rpar
t, w
here
diff
eren
ces
are
antic
ipat
ed; a
ntic
ipat
ed o
r kn
own
rela
tive
effe
cts
on th
e en
viro
nmen
t res
ultin
g fr
om th
e re
leas
e.
• T
he a
pplic
ant c
an a
lso
subm
it ot
her
scie
ntifi
c re
sear
ch a
s pa
rt o
f the
app
licat
ion.
Upo
n be
com
ing
awar
e of
new
info
rmat
ion
rega
rdin
g th
e en
viro
nmen
tal s
afet
y of
the
PNT
(e.g
. enh
ance
d w
eedi
ness
ch
arac
teri
stic
s), i
nclu
ding
the
risk
to h
uman
hea
lth (e
.g. e
xpos
ure
to a
llerg
ens)
that
cou
ld r
esul
t fr
om th
e re
leas
e, th
e ap
plic
ant m
ust i
mm
edia
tely
pro
vide
the
Plan
t Bio
safe
ty O
ffi ce
with
the
new
in
form
atio
n.
• T
he P
lant
Bio
safe
ty O
ffi ce
may
mai
ntai
n, c
hang
e, o
r re
mov
e ex
istin
g co
nditi
ons
resp
ectin
g th
e re
leas
e; im
pose
add
ition
al c
ondi
tions
; or
refu
se o
r ca
ncel
the
auth
oris
atio
n an
d re
quir
e th
e ap
plic
ant
to s
top
the
rele
ase
and
take
any
app
ropr
iate
act
ion
nece
ssar
y to
elim
inat
e fr
om, o
r m
inim
ise
the
risk
to
, the
env
iron
men
t.
• T
here
is a
dra
ft do
cum
ent t
hat o
utlin
es th
e ap
plic
atio
n re
quir
emen
ts fo
r no
tifi c
atio
n of
a r
elea
se o
f bi
otec
hnol
ogy-
deriv
ed li
vest
ock
anim
als.
Thi
s dr
aft a
ppea
rs to
app
ly to
con
fi ned
and
unc
onfi n
ed
rele
ases
. Inf
orm
atio
n re
quir
emen
ts in
clud
e in
form
atio
n: o
n th
e or
gani
sm; o
n th
e or
gani
sm’s
man
ufac
ture
or
impo
rt; o
n th
e in
trod
uctio
n of
the
orga
nism
; on
the
envi
ronm
enta
l fat
e of
the
orga
nism
; on
the
orga
nism
’s en
viro
nmen
tal e
ffect
s; o
n po
tent
ial a
dver
se e
ffect
s on
hum
an h
ealth
; on
test
dat
a th
at a
ssis
ts in
the
iden
tifi c
atio
n of
haz
ards
to h
uman
hea
lth a
nd e
nvir
onm
ent.
Con
side
ratio
n of
et
hica
l iss
ues
• I
n m
akin
g a
deci
sion
Min
iste
rs m
ay o
nly
dete
rmin
e w
heth
er th
e su
bsta
nce
is to
xic
or c
apab
le
of b
ecom
ing
toxi
c. N
o sp
ecifi
c m
entio
n of
eth
ics
or tr
ade
is m
ade.
How
ever
, the
Min
iste
r m
ay
take
into
acc
ount
fact
ors
such
as,
but
not
lim
ited
to s
ocia
l, ec
onom
ic a
nd te
chni
cal m
atte
rs
whe
n de
term
inin
g pr
even
tativ
e or
con
trol
act
ion
in r
elat
ion
to a
sub
stan
ce o
r in
pla
ns fo
r vi
rtua
l el
imin
atio
n of
the
subs
tanc
e.
201
and the Gene Technology Agreement
Prot
ectio
n of
co
nfi d
entia
l co
mm
erci
al
info
rmat
ion
• A
n ap
plic
ant m
ay r
eque
st th
at in
form
atio
n be
trea
ted
as c
onfi d
entia
l.
• T
he M
inis
ter
mus
t not
dis
clos
e an
y in
form
atio
n in
res
pect
of w
hich
a r
eque
st fo
r co
nfi d
entia
lity
has
been
mad
e un
less
: it
is in
the
publ
ic in
tere
st; o
r it
is d
iscl
osed
und
er a
n ag
reem
ent b
etw
een
the
Gov
ernm
ent o
f Can
ada
and
any
othe
r go
vern
men
t of C
anad
a or
gov
ernm
ent o
f a fo
reig
n st
ate
etc,
an
d th
e ag
ency
agr
ees
to k
eep
the
info
rmat
ion
confi
den
tial.
Con
ditio
ns th
at m
ay
be a
pplie
d•
Whe
re th
e M
inis
ter
susp
ects
that
a li
ving
org
anis
m is
toxi
c or
cap
able
of b
eing
toxi
c, th
e M
inis
ter
for
the
Envi
ronm
ent m
ay p
erm
it th
e m
anuf
actu
re o
r im
port
of t
he li
ving
org
anis
ms
subj
ect t
o an
y co
nditi
ons
that
the
Min
iste
r m
ay s
peci
fy.
• T
he P
lant
Bio
safe
ty O
ffi ce
may
mai
ntai
n, c
hang
e, o
r re
mov
e ex
istin
g co
nditi
ons
resp
ectin
g th
e re
leas
e; im
pose
add
ition
al c
ondi
tions
; or
refu
se o
r ca
ncel
the
auth
oris
atio
n an
d re
quir
e th
e ap
plic
ant
to s
top
the
rele
ase
and
take
any
app
ropr
iate
act
ion
nece
ssar
y to
elim
inat
e fr
om, o
r m
inim
ise
the
risk
to
, the
env
iron
men
t.
Mon
itori
ng,
surv
eilla
nce
and
enfo
rcem
ent p
ower
s
• M
onito
ring
and
enf
orce
men
t pow
ers
are
the
sam
e as
thos
e de
scri
bed
abo
ve b
ecau
se u
ncon
fi ned
re
leas
es a
re g
over
ned
by th
e sa
me
legi
slat
ion
as c
onfi n
ed r
elea
ses.
Pena
lties
• P
enal
ties
that
may
be
impo
sed
in r
elat
ion
to u
ncon
fi ned
rel
ease
are
the
sam
e as
thos
e de
scri
bed
for
the
Feed
s A
ct fo
r co
nfi n
ed r
elea
ses
beca
use
unco
nfi n
ed r
elea
ses
are
gove
rned
by
the
sam
e le
gisl
atio
n as
con
fi ned
rel
ease
s.
Plac
ing
on t
he m
arke
t G
MO
s fo
r fo
od o
r fe
ed
Legi
slat
ion
• F
ood
and
Dru
gs A
ct.
• F
eeds
Act
and
am
endm
ents
and
reg
ulat
ions
.
• D
irec
tive
95-0
3.
Appendix 8
202
Statutory Review of the Gene Technology Act 2000
Cov
erag
e of
le
gisl
atio
n•
The
Foo
d an
d D
rugs
Act
reg
ulat
es th
e us
e of
GM
Os
(der
ived
from
pla
nt a
nd a
nim
al s
ourc
es) t
hat a
re
inte
nded
for
use
as n
ovel
food
s.
• T
he F
eeds
Act
gov
erns
the
use
of fe
ed w
ithin
Can
ada
and
ensu
res
that
it is
saf
e to
use
.
• D
irec
tive
95-0
3 ap
pear
s as
thou
gh it
can
be
used
for
appl
ying
for
rele
ase
of n
ovel
feed
(pla
nt s
ourc
e)
for
even
tual
com
mer
cial
isat
ion.
App
licat
ion
proc
ess
for
unco
nfi n
ed r
elea
se
of G
MO
s in
to th
e en
viro
nmen
t for
use
as
feed
for
lives
tock
an
d la
bora
tory
an
imal
s (u
sual
ly
for
the
purp
ose
of
com
mer
cial
isat
ion)
• U
nder
the
Feed
s A
ct a
nd it
s am
endm
ents
and
reg
ulat
ions
a w
ritte
n no
tifi c
atio
n of
the
prop
osed
re
leas
e m
ust b
e m
ade
to th
e M
inis
ter,
incl
udin
g in
form
atio
n su
ch a
s: t
he p
artic
ular
s of
the
rele
ase;
co
nfi n
emen
t and
mon
itori
ng p
roce
dure
s; m
etho
ds fo
r sa
fe d
ispo
sal;
cont
inge
ncy
plan
s to
miti
gate
ad
vers
e ef
fect
s on
hum
ans
and
the
envi
ronm
ent i
n th
e ev
ent o
f acc
iden
tal r
elea
se; t
he p
artic
ular
s of
th
e no
vel t
rait;
any
res
ults
from
dat
a or
res
earc
h do
ne to
iden
tify
risk
s to
the
envi
ronm
ent o
r hu
man
he
alth
. Th
e M
inis
ter
for A
gric
ultu
re a
nd A
gri-
food
s ca
n th
en e
ither
aut
hori
se o
r re
fuse
to a
utho
rise
th
e re
leas
e of
the
nove
l fee
d an
d sh
all c
onsi
der
the
mag
nitu
de o
f exp
osur
e of
the
rele
ase,
the
effe
cts
on th
e en
viro
nmen
t and
whe
ther
the
nove
l fee
d is
toxi
c. T
he a
pplic
atio
n sh
all b
e ac
com
pani
ed w
ith
evid
ence
(suc
h as
sci
entifi
c r
esea
rch)
to p
erm
it an
ass
essm
ent o
r ev
alua
tion
of th
e sa
fety
and
effi
cacy
of
the
feed
in r
espe
ct o
f liv
esto
ck a
nd it
s po
tent
ial e
ffect
on
hum
ans
and
on th
e en
viro
nmen
t.
• D
irect
ive
95-0
3 pr
ovid
es th
e gu
idel
ines
for t
he c
ompl
etio
n of
an
appl
icat
ion
for t
he u
ncon
fi ned
rel
ease
of
a n
ovel
feed
from
pla
nt s
ourc
es.
App
licat
ions
sho
uld
cont
ain:
suffi c
ient
dat
a ab
out t
he n
ovel
trai
t; in
form
atio
n ab
out t
he m
odifi
catio
n hi
stor
y; c
hara
cter
isat
ion
of th
e D
NA
inse
rted,
if a
ny; n
utrit
iona
l da
ta, a
llerg
enic
ity d
ata;
toxi
colo
gy d
ata;
die
tary
exp
osur
e; la
bora
tory
ani
mal
/live
stoc
k fe
edin
g tri
al
data
; env
ironm
enta
l ris
k as
sess
men
t; m
etho
d of
det
ectio
n. A
dec
isio
n is
then
mad
e on
the
info
rmat
ion
prov
ided
in th
e ap
plic
atio
n.
• Th
e ap
plic
atio
n pr
oced
ure
and
info
rmat
ion
requ
irem
ents
for r
elea
sing
of a
nov
el fe
ed o
f an
anim
al o
rigin
is
sim
ilar t
o th
at fo
r a n
ovel
feed
from
a p
lant
sou
rce
and
is o
utlin
ed in
the
Feed
s Act
and
regu
latio
ns.
203
and the Gene Technology Agreement
App
licat
ion
proc
ess
for
unco
nfi n
ed r
elea
se
of G
MO
s in
to th
e en
viro
nmen
t for
use
as
feed
for
lives
tock
an
d la
bora
tory
an
imal
s (u
sual
ly
for
the
purp
ose
of
com
mer
cial
isat
ion)
(c
ontin
ued)
• T
here
is a
dra
ft do
cum
ent t
hat o
utlin
es th
e ap
plic
atio
n re
quir
emen
ts fo
r no
tifi c
atio
n of
a r
elea
se o
f bi
otec
hnol
ogy-
deriv
ed li
vest
ock
anim
als.
Thi
s dr
aft a
ppea
rs to
app
ly to
con
fi ned
and
unc
onfi n
ed
rele
ases
. In
form
atio
n re
quir
emen
ts in
clud
e in
form
atio
n: o
n th
e or
gani
sm; o
n th
e or
gani
sm’s
man
ufac
ture
or
impo
rt; o
n th
e in
trod
uctio
n of
the
orga
nism
; on
the
envi
ronm
enta
l fat
e of
the
orga
nism
; on
the
orga
nism
’s en
viro
nmen
tal e
ffect
s; o
n po
tent
ial a
dver
se e
ffect
s on
hum
an h
ealth
; on
test
dat
a th
at a
ssis
ts in
the
iden
tifi c
atio
n of
haz
ards
to h
uman
hea
lth a
nd e
nvir
onm
ent.
Con
side
ratio
n of
et
hica
l iss
ues
• I
n m
akin
g a
deci
sion
Min
iste
rs m
ay o
nly
dete
rmin
e w
heth
er th
e su
bsta
nce
is to
xic
or c
apab
le
of b
ecom
ing
toxi
c. N
o sp
ecifi
c m
entio
n of
eth
ics
or tr
ade
is m
ade.
How
ever
, the
Min
iste
r m
ay
take
into
acc
ount
fact
ors
such
as,
but
not
lim
ited
to s
ocia
l, ec
onom
ic a
nd te
chni
cal m
atte
rs
whe
n de
term
inin
g pr
even
tativ
e or
con
trol
act
ion
in r
elat
ion
to a
sub
stan
ce o
r in
pla
ns fo
r vi
rtua
l el
imin
atio
n of
the
subs
tanc
e.
Prot
ectio
n of
co
nfi d
entia
l co
mm
erci
al
info
rmat
ion
• A
n ap
plic
ant m
ay r
eque
st th
at in
form
atio
n be
trea
ted
as c
onfi d
entia
l.
• T
he M
inis
ter
mus
t not
dis
clos
e an
y in
form
atio
n in
res
pect
of w
hich
a r
eque
st fo
r co
nfi d
entia
lity
has
been
mad
e un
less
: it
is in
the
publ
ic in
tere
st; o
r it
is d
iscl
osed
und
er a
n ag
reem
ent b
etw
een
the
Gov
ernm
ent o
f Can
ada
and
any
othe
r go
vern
men
t of C
anad
a or
gov
ernm
ent o
f a fo
reig
n st
ate
etc,
an
d th
e ag
ency
agr
ees
to k
eep
the
info
rmat
ion
confi
den
tial.
Con
ditio
ns th
at m
ay
be a
pplie
d•
The
Pla
nt B
iosa
fety
Offi
ce m
ay m
aint
ain,
cha
nge,
or
rem
ove
exis
ting
cond
ition
s re
spec
ting
the
rele
ase;
impo
se a
dditi
onal
con
ditio
ns; o
r re
fuse
or
canc
el th
e au
thor
isat
ion
and
requ
ire
the
appl
ican
t to
sto
p th
e re
leas
e an
d ta
ke a
ny a
ppro
pria
te a
ctio
n ne
cess
ary
to e
limin
ate
from
, or
min
imis
e th
e ri
sk
to, t
he e
nvir
onm
ent.
Appendix 8
204
Statutory Review of the Gene Technology Act 2000
Mon
itori
ng,
surv
eilla
nce
and
enfo
rcem
ent p
ower
s
• M
onito
ring
and
enf
orce
men
t pow
ers
are
the
sam
e as
thos
e de
scri
bed
in th
e ab
ove
tabl
e be
caus
e un
confi
ned
rel
ease
s ar
e go
vern
ed b
y th
e sa
me
legi
slat
ion
as c
onfi n
ed r
elea
ses.
Pena
lties
• P
enal
ties
that
may
be
impo
sed
in r
elat
ion
to u
ncon
fi ned
rel
ease
of G
MO
s in
tend
ed fo
r fe
ed u
se
are
the
sam
e as
thos
e de
scri
bed
for
the
Feed
s A
ct fo
r co
nfi n
ed r
elea
ses
beca
use
rele
ase
of G
MO
s in
tend
ed fo
r fe
ed u
se a
re g
over
ned
by th
e sa
me
legi
slat
ion
as c
onfi n
ed r
elea
ses.
App
licat
ion
proc
ess
for
unco
nfi n
ed r
elea
se
of G
MO
s in
to th
e en
viro
nmen
t for
use
as
food
for
hum
an
cons
umpt
ion
(usu
ally
for
the
purp
ose
of
com
mer
cial
isat
ion)
• N
o no
vel f
ood
may
be
sold
or
adve
rtis
ed w
ithou
t fi r
st s
ubm
ittin
g a
notifi
cat
ion
for
the
inte
ntio
n to
do
so to
the
deci
sion
mak
er.
• T
he n
otifi
catio
n re
quir
es th
e fo
llow
ing
info
rmat
ion:
det
ails
of t
he fo
od, i
nclu
ding
info
rmat
ion
conc
erni
ng it
s de
velo
pmen
t; de
tails
of t
he m
etho
d by
whi
ch it
is m
anuf
actu
red,
pre
pare
d, p
rese
rved
, pa
ckag
ed a
nd s
tore
d; d
etai
ls o
f the
maj
or c
hang
e, if
any
; inf
orm
atio
n co
ncer
ning
its
inte
nded
use
an
d di
rect
ions
for
its p
repa
ratio
n; in
form
atio
n co
ncer
ning
its
hist
ory
of u
se a
s a
food
; inf
orm
atio
n re
lied
on to
est
ablis
h th
at th
e no
vel f
ood
is s
afe
for
cons
umpt
ion;
the
estim
ated
con
sum
ptio
n le
vel o
f th
e no
vel f
ood.
• U
pon
rece
ivin
g th
e in
form
atio
n, th
e de
cisi
on m
aker
sha
ll, w
ithin
45
days
, not
ify th
e ap
plic
ant
that
the
info
rmat
ion
prov
ided
is s
uffi c
ient
if th
e fo
od is
saf
e, o
r re
ques
t fur
ther
info
rmat
ion.
Upo
n re
ceiv
ing
the
addi
tiona
l inf
orm
atio
n, th
e de
cisi
on m
aker
sha
ll no
tify
the
appl
ican
t with
in 9
0 da
ys
that
the
info
rmat
ion
was
suffi c
ient
if th
e fo
od is
saf
e.
• Th
e no
vel f
ood
mus
t und
ergo
num
erou
s sa
fety
ass
essm
ents
bef
ore
bein
g ap
prov
ed fo
r use
as
food
. Th
is
may
incl
ude
usin
g da
ta fr
om a
nim
al s
tudi
es o
r tria
ls re
gard
ing
its to
xici
ty a
nd a
llerg
enic
ity.
• I
n ev
alua
ting
GM
food
s fo
r sa
fety
, gov
ernm
ent s
cien
tifi c
eva
luat
ors
may
con
side
r th
e fo
llow
ing:
how
th
e fo
od c
rop
was
dev
elop
ed, i
nclu
ding
the
chan
ges
in th
e pl
ant’s
/ani
mal
’s m
olec
ular
str
uctu
re; h
ow
the
GM
food
com
pare
s w
ith it
s co
nven
tiona
l cou
nter
part
; whe
ther
the
GM
food
con
tain
s ne
w to
xins
(to
ani
mal
s, h
uman
s an
d th
e en
viro
nmen
t); w
heth
er th
e G
M fo
od m
ay c
ause
alle
rgie
s.
205
and the Gene Technology Agreement
Con
side
ratio
n of
et
hica
l iss
ues
• N
o sp
ecifi
c m
entio
n of
this
was
foun
d in
the
rele
vant
legi
slat
ion.
Prot
ectio
n of
co
nfi d
entia
l co
mm
erci
al
info
rmat
ion
• N
o sp
ecifi
c m
entio
n of
this
was
foun
d in
the
Food
and
Dru
gs A
ct o
r its
reg
ulat
ions
, or
in th
e dr
aft
guid
elin
es fo
r no
tifi c
atio
n fo
r th
e in
tend
ed r
elea
se o
f bio
tech
nolo
gy-d
eriv
ed a
nim
als.
Con
ditio
ns th
at m
ay
be a
pplie
d•
The
re w
as n
o m
entio
n of
spe
cifi c
con
ditio
ns r
equi
red
to b
e m
et o
ther
than
thos
e re
quir
ed w
hen
an
appl
icat
ion/
notifi
cat
ion
for
the
nove
l foo
d to
be
plac
ed o
n th
e m
arke
t is
mad
e.
Mon
itori
ng,
surv
eilla
nce
and
enfo
rcem
ent p
ower
s
• T
he F
ood
and
Dru
gs A
ct h
as p
rovi
sion
s th
at a
llow
an
insp
ecto
r fr
om th
e C
anad
ian
Food
Insp
ectio
n A
genc
y to
con
duct
insp
ectio
ns.
An
insp
ecto
r m
ay, a
t any
rea
sona
ble
time,
ent
er g
roun
ds w
here
the
insp
ecto
r be
lieve
s on
rea
sona
ble
grou
nds
any
artic
le to
whi
ch th
is A
ct o
r th
e re
gula
tions
app
ly is
m
anuf
actu
red,
pre
pare
d, p
rese
rved
, pac
kage
d or
sto
red
to:
exam
ine
and
take
sam
ples
of a
rtic
les;
op
en a
nd e
xam
ine
rece
ptac
les
or p
acka
ges;
exa
min
e or
mak
e co
pies
of d
ocum
ents
that
con
tain
in
form
atio
n re
leva
nt to
the
enfo
rcem
ent o
f the
Act
; sei
ze a
nd d
etai
n ar
ticle
s.
Pena
lties
• P
erso
ns w
ho c
ontr
aven
e th
e Fo
od a
nd D
rugs
Act
: on
a s
umm
ary
conv
ictio
n fo
r a fi r
st o
ffenc
e m
ay
face
a fi
ne o
f no
mor
e th
an C
A$5
00 o
r a
pris
on te
rm n
o m
ore
than
thre
e m
onth
s or
bot
h; fo
r a
subs
eque
nt o
ffenc
e, a
fi ne
no
mor
e th
an C
A$1
000
or a
pri
son
term
of n
o m
ore
than
six
mon
ths
or
both
; for
a c
onvi
ctio
n on
indi
ctm
ent,
a fi n
e no
mor
e th
an C
A$5
000
or a
pri
son
term
no
mor
e th
an
thre
e ye
ars
or b
oth.
Appendix 8
206
Statutory Review of the Gene Technology Act 2000
Polic
y an
d G
over
nanc
e is
sues
Liab
ility
for
cont
amin
atio
nTh
e C
EPA
pro
vide
s fo
r tw
o ty
pes
of a
ctio
n:
(1) E
nvir
onm
enta
l Pro
tect
ion
Act
ions
.
A
ny C
anad
ian
citiz
en c
an a
pply
for
an in
vest
igat
ion
of a
n al
lege
d of
fenc
e in
con
trav
entio
n of
the
legi
slat
ion
— th
is is
cal
led
an ‘E
nvir
onm
enta
l Pro
tect
ion
Act
ion’
(EPA
). A
n EP
A c
an o
nly
be b
ough
t if:
(a) t
he M
inis
ters
inve
stig
atio
n w
as in
adeq
uate
or
non-
exis
tent
; and
(b) t
here
was
an
alle
ged
brea
ch o
f the
Act
; and
(c) t
he a
llege
d br
each
is c
ausi
ng s
ignifi c
ant h
arm
to th
e en
viro
nmen
t.
A
n EP
A m
ay n
ot b
e bo
ught
if th
e al
lege
d co
nduc
t was
:
(a) t
aken
to c
orre
ct o
r miti
gate
har
m o
r ris
k of
har
m to
the
envi
ronm
ent o
r hum
an p
lant
or a
nim
al li
fe;
(b) t
aken
to p
rote
ct n
atio
nal s
ecur
ity; o
r (c
) was
rea
sona
ble
and
cons
iste
nt w
ith p
ublic
saf
ety.
D
efen
ces
to a
n EP
A in
clud
e:
(a) d
ue d
ilige
nce;
(b) a
utho
risa
tion
by a
noth
er a
ct o
f par
liam
ent;
(c) a
n offi c
ially
indu
ced
mis
take
of l
aw; a
nd
(d) a
ny o
ther
def
ence
s av
aila
ble
unde
r ge
nera
l law
.
In
add
ition
, an
actio
n m
ay b
e di
smis
sed
if it
is n
ot in
the
publ
ic in
tere
st. T
he o
nly
relie
f tha
t is
avai
labl
e if
an E
PA is
suc
cess
ful i
s an
inju
nctio
n (s
topp
ing
the
defe
ndan
t fro
m d
oing
som
ethi
ng o
r fo
rcin
g th
em to
do
som
ethi
ng) o
r an
ord
er to
the
part
ies
to n
egot
iate
a p
lan
to c
orre
ct o
r m
itiga
te th
e ha
rm to
the
envi
ronm
ent e
tc, c
osts
of t
he a
ctio
n. T
here
can
be
no a
war
d of
dam
ages
in th
e ev
ent o
f a
succ
essf
ul E
PA.
Th
is a
ctio
n do
es n
ot a
ssis
t ind
ivid
uals
affe
cted
by
cont
amin
atio
n to
see
k da
mag
es fo
r lo
ss s
uffe
red;
ra
ther
it e
nabl
es th
em to
bri
ng a
n ac
tion
if th
ere
has
been
a b
reac
h of
the
Act
, to
stop
the
activ
ity
cont
inui
ng.
207
and the Gene Technology Agreement
Liab
ility
for
cont
amin
atio
n (c
ontin
ued)
(2) C
omm
on la
w a
ctio
ns
Th
e A
ct e
xplic
itly
reite
rate
s th
e co
mm
on la
w r
ight
for
a th
ird
part
y w
ho h
as s
uffe
red
dam
age
to g
o to
cou
rt to
see
k da
mag
es fo
r su
ch lo
ss.
The
actio
n th
at m
ay b
e br
ough
t (an
d th
e da
mag
es a
ble
to
be r
ecov
ered
) will
dep
end
entir
ely
on th
e ap
plic
atio
n of
ord
inar
y pr
inci
ples
of l
aw (f
or e
xam
ple,
nu
isan
ce, n
eglig
ence
). Th
e C
anad
ian
Envi
ronm
ent P
rote
ctio
n A
ct d
oes
not e
stab
lish
any
stat
utor
y ri
ght t
o re
cove
r fo
r lo
ss o
r da
mag
e. T
here
is a
str
ict l
iabi
lity
arra
ngem
ent i
n th
e C
EPA
199
9 w
here
th
e pe
rson
who
ow
ns o
r ha
s th
e ch
arge
, man
agem
ent o
r co
ntro
l of a
sub
stan
ce im
med
iate
ly b
efor
e an
env
iron
men
tal e
mer
genc
y is
liab
le:
– fo
r re
stor
ing
any
part
of t
he e
nvir
onm
ent d
amag
ed b
y or
dur
ing
the
emer
genc
y; a
nd
– fo
r co
sts
and
expe
nses
incu
rred
by
a pu
blic
dep
artm
ent i
n re
spec
t of m
easu
res
take
n to
pre
vent
, re
pair,
rem
edy
or m
inim
ise
the
dam
age
to th
e en
viro
nmen
t res
ultin
g fr
om th
e e
mer
genc
y,
incl
udin
g m
easu
res
take
n in
ant
icip
atio
n of
the
envi
ronm
enta
l em
erge
ncy;
as
the
pers
on’s
liabi
lity
does
not
dep
end
on p
roof
of f
ault
or n
eglig
ence
.
H
owev
er, t
he p
erso
n’s
stri
ct li
abili
ty m
ay b
e re
duce
d or
nul
lifi e
d if
the
pers
on c
an s
how
that
th
e em
erge
ncy
was
cau
sed
by: a
n ac
t of w
ar; a
n ex
cept
iona
l, ir
resi
stib
le a
nd in
evita
ble
natu
ral
phen
omen
on; a
thir
d pa
rty
with
the
inte
nt to
cau
se d
amag
e; n
eglig
ence
or
wro
ngfu
l act
of
gove
rnm
ent,
publ
ic d
epar
tmen
t or
auth
ority
.
Expe
rt c
omm
ittee
s•
Can
adia
n B
iote
chno
logy
Adv
isor
y C
omm
ittee
(CBA
C):
is a
non
-sta
tuto
ry c
omm
ittee
est
ablis
hed
by
the
fede
ral g
over
nmen
t to
prov
ide
advi
ce to
a C
oord
inat
ing
Com
mitt
ee o
f fed
eral
min
iste
rs o
n br
oad
polic
y is
sues
ass
ocia
ted
with
the
ethi
cal,
soci
al, r
egul
ator
y, e
cono
mic
, sci
entifi
c, e
nvir
onm
enta
l an
d he
alth
asp
ects
of b
iote
chno
logy
. CBA
C is
mad
e up
of 1
2 m
embe
rs d
raw
n fr
om th
e sc
ient
ifi c,
bu
sine
ss, g
ener
al p
ublic
, eth
ics
and
envi
ronm
enta
l com
mun
ities
.
• T
he C
EPA
est
ablis
hes
a N
atio
nal A
dvis
ory
Com
mitt
ee th
at c
an p
rovi
de b
oth
tech
nica
l and
pol
icy
advi
ce to
the
Min
iste
r on
: pro
pose
d re
gula
tions
for
toxi
c su
bsta
nces
; pro
pose
d re
gula
tions
on
envi
ronm
enta
l em
erge
ncie
s; a
co-
oper
ativ
e co
ordi
nate
d ap
proa
ch to
the
man
agem
ent o
f tox
ic
subs
tanc
es; a
nd a
ny o
ther
mat
ter
of m
utua
l int
eres
t.
• T
his
Com
mitt
ee lo
oks
at a
ll en
viro
nmen
tal i
ssue
s no
t jus
t bio
tech
nolo
gy.
Appendix 8
208
Statutory Review of the Gene Technology Act 2000
Res
earc
h•
The
Min
iste
r fo
r th
e En
viro
nmen
t and
Min
iste
r fo
r H
ealth
mus
t bot
h un
dert
ake
rese
arch
and
stu
dies
in
to e
nvir
onm
enta
l con
tam
inat
ion
aris
ing
from
dis
turb
ance
s of
eco
syst
ems
by h
uman
act
ivity
, and
th
e ro
le o
f sub
stan
ces
in il
lnes
ses
or h
ealth
pro
blem
s, r
espe
ctiv
ely.
The
Min
iste
r fo
r th
e En
viro
nmen
t an
d th
e M
inis
ter
for
Hea
lth m
ay c
olle
ct o
r ge
nera
te d
ata
and
cond
uct i
nves
tigat
ions
res
pect
ing
any
mat
ter
in r
elat
ion
to a
sub
stan
ce w
hen
asse
ssin
g w
heth
er a
sub
stan
ce is
toxi
c.
Oth
er
The
prec
autio
nary
pr
inci
ple
• T
he p
ream
ble
to C
EPA
sta
tes
that
‘whe
reas
the
Gov
ernm
ent o
f Can
ada
is c
omm
itted
to im
plem
entin
g th
e pr
ecau
tiona
ry p
rinc
iple
that
, whe
re th
ere
are
thre
ats
of s
erio
us o
r ir
reve
rsib
le d
amag
e, la
ck o
f ful
l sc
ient
ifi c
cert
aint
y sh
all n
ot b
e us
ed a
s a
reas
on fo
r po
stpo
ning
cos
t-ef
fect
ive
mea
sure
s to
pre
vent
en
viro
nmen
tal d
amag
e.
• I
n gi
ving
adv
ice
and
reco
mm
enda
tions
to th
e M
inis
ter,
the
Nat
iona
l Adv
isor
y C
omm
ittee
sha
ll us
e th
e pr
ecau
tiona
ry p
rinc
iple
.
Cos
t rec
over
y•
Fee
s ar
e at
tach
ed to
not
ifi ca
tions
to th
e re
leva
nt g
over
nmen
t dep
artm
ents
for
prop
osed
use
of n
ovel
pl
ants
, fee
d or
food
. The
Can
adia
n G
over
nmen
t may
als
o re
cove
r al
l cos
ts o
f, an
d in
cide
ntal
to,
taki
ng r
easo
nabl
e m
easu
res
to p
reve
nt r
elea
ses
that
end
ange
r th
e en
viro
nmen
t and
pub
lic s
afet
y, o
r to
rem
edy
any
dang
erou
s si
tuat
ion
or r
educ
e or
miti
gate
any
dan
ger
to th
e en
viro
nmen
t or
to h
uman
lif
e th
at r
esul
ts, o
r m
ay r
esul
t, fr
om th
e re
leas
e of
a to
xic
subs
tanc
e in
bre
ach
of c
ondi
tions
(alth
ough
th
ere
is a
5 y
ear
limita
tion
peri
od).
Mor
ator
ium
• N
o m
orat
oriu
m.
Oth
er•
Can
ada
is c
urre
ntly
pro
posi
ng a
reg
ulat
ion
unde
r th
e C
EPA
(199
9) th
at w
ould
allo
w C
anad
a to
im
plem
ent t
he C
arte
gena
pro
toco
l. H
owev
er, l
ivin
g m
odifi
ed o
rgan
ism
s th
at a
re p
harm
aceu
tical
s fo
r hu
man
use
are
exc
lude
d fr
om th
e re
gula
tion.
• A
nov
el fe
ed fr
om a
PN
T th
at c
ould
rea
sona
bly
be e
xpec
ted
to b
e re
leas
ed in
to th
e en
viro
nmen
t or
used
as
food
will
not
be
auth
oris
ed fo
r liv
esto
ck fe
ed u
se u
ntil:
the
Pla
nt B
iosa
fety
Offi
ce, C
FIA
, is
read
y to
aut
hori
se th
e PN
T fo
r en
viro
nmen
tal r
elea
se; t
he N
ovel
Foo
ds S
ectio
n, H
ealth
Can
ada,
is
read
y to
pro
vide
not
ifi ca
tion
of n
o ob
ject
ion
for
hum
an fo
od u
se o
f the
nov
el fo
od.
209
and the Gene Technology Agreement
RE
GU
LA
TIO
N O
F G
EN
E T
EC
HN
OL
OG
Y I
N A
RG
EN
TIN
A
SUM
MA
RY —
The
Sec
reta
ria
de A
gric
ultu
ra, G
anad
eria
, Pes
ca y
Alim
ento
s (S
AG
PyA
)/Sec
reta
ry o
f Agr
icul
ture
, Liv
esto
ck,
Fish
erie
s an
d Fo
od is
res
pons
ible
for
gran
ting
licen
ces
to d
ealin
gs w
ith G
MO
s. S
AG
PyA
bas
es it
s de
cisi
ons
on th
e re
com
men
datio
n of
an
expe
rt c
omm
ittee
: Com
isió
n N
acio
nal A
seso
ra d
e B
iote
cnol
ogía
Agr
opec
uari
a (C
ON
AB
IA)/T
he
Nat
iona
l Adv
isor
y C
omm
ittee
on
Agr
icul
tura
l Bio
safe
ty.
• T
hese
rul
es a
re p
art o
f the
gen
eral
reg
ulat
ory
syst
em g
over
ning
the
agri
cultu
ral e
xist
ing
regu
latio
ns in
Arg
entin
a re
late
d to
pla
nt p
rote
ctio
n (D
ecre
e-La
w o
f Agr
icul
tura
l Pro
duct
ion
Hea
lth D
efen
se. N
° 67
04/6
6 an
d its
am
endm
ents
), se
eds
and
phyt
ogen
etic
cre
atio
ns (S
eed
and
Phyt
ogen
etic
Cre
atio
ns L
aw, N
º 20
.247
/73
and
its r
egul
ator
y D
ecre
e), a
nd a
nim
al h
ealth
(L
aw o
f Vet
erin
aria
n Pr
oduc
ts.
Supe
rvis
ion
of th
e cr
eatio
n an
d co
mm
erci
alis
atio
n. N
º 13
.636
/49)
.
Con
tain
ed w
ork
wit
h G
MO
s
Res
pons
ible
age
ncy
• C
ON
AB
IA/S
AG
PyA
.
Legi
slat
ion
• R
esol
utio
n N
°31/
03 o
f SA
GPy
A 1
1 Ju
ly 2
003
spec
ifi es
the
appl
icat
ion
proc
edur
e fo
r th
e is
sue
of li
cenc
es fo
r Ex
peri
men
tatio
n on
and
/ or
Rel
ease
into
the
Envi
ronm
ent o
f Gen
etic
ally
M
odifi
ed M
icro
-org
anis
ms
and/
or th
eir
prod
ucts
for
use
in a
nim
als;
the
rele
ase
of g
enet
ical
ly
mod
ifi ed
ani
mal
s ar
e re
gula
ted
by R
esol
utio
n N
°656
of S
AG
PyA
11
July
200
3.
Inte
ntio
nal r
elea
ses
of G
MO
s in
the
env
iron
men
t
Res
pons
ible
age
ncy
• C
ON
AB
IA/S
AG
PyA
. C
omm
erci
al r
elea
ses
are
also
ass
esse
d by
Hea
lth, T
rade
and
See
d ag
enci
es.
Legi
slat
ion
• F
ield
tria
ls a
re g
over
ned
unde
r R
esol
utio
n N
°57
of S
AG
PyA
18
July
, 200
3; c
omm
erci
al
rele
ases
are
als
o su
bjec
t to
SAG
PyA
Reg
ulat
ion
No.
511
/98
as w
ell a
s ge
nera
l see
d an
d he
alth
law
s.
Cov
erag
e of
the
legi
slat
ion
• T
he d
elib
erat
e re
leas
e of
GM
Os
into
the
envi
ronm
ent.
Appendix 8
210
Statutory Review of the Gene Technology Act 2000
Ass
essm
ent p
roce
ss fo
r in
tent
iona
l rel
ease
s of
a
GM
O in
to th
e en
viro
nmen
t (fi
eld
tria
ls)
• I
nfor
mat
ion
requ
irem
ents
for
appl
icat
ions
are
bas
ed o
n th
e U
S D
epar
tmen
t of A
gric
ultu
re’s
expe
rien
ce.
CO
NA
BIA
’s te
chni
cal s
taff
mak
e a
prel
imin
ary
revi
ew o
f the
app
licat
ions
for
com
plet
enes
s an
d da
ta q
ualit
y. T
he C
ON
AB
IA c
omm
ittee
then
und
erta
kes
a ri
sk a
sses
smen
t an
alys
is. T
he r
isk
asse
ssm
ent i
nclu
des:
– as
sess
men
t of t
he b
iosa
fety
of t
he r
elea
sed
orga
nism
s;
– as
sess
men
t of t
he a
gro-
ecol
ogic
al fe
atur
es o
f the
site
whe
re th
ey a
re in
tend
ed to
be
rele
ased
; and
– su
itabi
lity
of th
e pe
rson
(s) r
espo
nsib
le fo
r co
nduc
ting
the fi e
ld tr
ial.
• A
utho
risa
tions
for fi e
ld tr
ials
are
then
issu
ed b
y SA
GPy
A b
ased
on
CO
NA
BIA
’s re
com
men
datio
n.
• A
fter
at le
ast o
ne fi
eld
tria
l and
the
safe
ty o
f the
GM
O h
as b
een
dem
onst
rate
d, a
n ap
plic
ant
can
appl
y fo
r m
ore fl e
xibl
e fi e
ld tr
ial c
ondi
tions
for
that
GM
O r
efer
red
to a
s ‘fl
exib
iliza
ción
’ (S
AG
PyA
Res
olut
ion
131/
98).
Afte
r SA
GPy
A g
rant
s fl e
xibi
lizac
ión,
furt
her
rele
ases
into
the
envi
ronm
ent o
f tha
t GM
O w
ill o
nly
need
the
appl
ican
t to
subm
it in
form
atio
n on
:
–
the
area
sow
n;
–
the
date
of s
owin
g; a
nd
–
the
site
of r
elea
se a
nd th
e ha
rves
t dat
e.
Proc
edur
e fo
r th
e pl
acin
g of
GM
Os
or p
rodu
cts
cont
aini
ng G
MO
s on
the
mar
ket
• A
fl ex
ibili
zaci
ón p
erm
it is
als
o th
e fi r
st s
tage
to g
et a
ppro
val f
or a
com
mer
cial
rel
ease
. In
addi
tion,
see
d co
mm
erci
alis
atio
n is
sub
ject
to th
e fo
llow
ing
term
s an
d co
nditi
ons:
• N
atio
nal S
ervi
ce o
f Agr
ifood
Hea
lth a
nd Q
ualit
y ap
prov
al fo
r us
e as
food
or
feed
. Th
is is
as
sess
ed b
y an
alys
is o
f: (1
) nat
ural
toxi
ns; (
2) n
ew fo
rms
of to
xins
; (3)
hom
olog
y of
the
new
ly
expr
esse
d pr
otei
ns w
ith o
ther
kno
wn
alle
rgen
s; (4
) nut
ritio
nal c
hang
es; (
5) n
utri
tiona
l cha
nges
an
d nu
triti
onal
cha
ract
eris
atio
n re
sulti
ng fr
om p
roce
ssin
g m
etho
ds; (
6) m
odifi
catio
ns in
the
bioa
vaila
bilit
y of
mac
ronu
trie
nts
and/
or m
icro
nutr
ient
s; (7
) cha
ract
eris
atio
n of
the
mod
ifi ed
fo
odst
uff w
ith r
egar
d to
its
safe
ty fo
r hu
man
and
ani
mal
hea
lth.
211
and the Gene Technology Agreement
Proc
edur
e fo
r th
e pl
acin
g of
GM
Os
or p
rodu
cts
cont
aini
ng G
MO
s on
the
mar
ket (
cont
inue
d)
• A
ppro
val f
or m
arke
ting
by th
e N
atio
nal D
ivis
ion
of A
grifo
od M
arke
ts o
f the
Sec
reta
riat
, w
hich
ass
esse
s th
e tr
ade
and
mar
ketin
g im
pact
s. T
his
asse
ssm
ent s
eeks
to a
void
any
pot
entia
l ne
gativ
e im
pact
on
Arg
entin
e ex
port
s.
• C
ompl
ianc
e w
ith th
e re
quir
emen
ts s
et fo
rth
by th
e IN
ASE
for
regi
stra
tion
of th
e m
ater
ial i
n th
e N
atio
nal C
ultiv
ar R
egis
try
and
in th
e O
ffi ci
al C
ertifi
cat
ion
regu
latio
ns.
• A
s w
ith fi
eld
tria
ls th
e fi n
al a
ppro
val i
s m
ade
by S
AG
PyA
.
Con
side
ratio
n of
eth
ical
is
sues
• T
here
is n
o sp
ecifi
c m
entio
n m
ade
of c
onsi
dera
tion
of e
thic
al c
once
rns.
Publ
ic c
onsu
ltatio
n on
ap
plic
atio
ns•
The
re is
no
spec
ifi c
men
tion
of p
ublic
con
sulta
tion
on a
pplic
atio
ns.
Ann
ual r
epor
ts a
nd
deta
ils o
f GM
Os
appr
oved
are
list
ed o
n C
ON
AB
IA’s
web
site
.
Con
ditio
ns th
at m
ay b
e ap
plie
d•
The
Res
olut
ion
prov
ides
that
com
pete
nt a
utho
ritie
s m
ay g
rant
app
rova
ls s
ubje
ct to
con
ditio
ns.
Mon
itori
ng, s
urve
illan
ce
and
enfo
rcem
ent p
ower
s•
Mon
itori
ng o
f the
fi el
d tr
ials
is th
e re
spon
sibi
lity
of th
e N
atio
nal S
eeds
Inst
itute
and
of t
he
Nat
iona
l Ser
vice
of A
grifo
od H
ealth
and
Qua
lity.
The
pur
pose
s of
the
mon
itori
ng a
re th
e on
-si
te v
erifi
catio
n of
com
plia
nce
with
the
tria
l con
ditio
ns a
s ap
prov
ed in
the
appl
icat
ion
and
that
the
mea
sure
s ta
ken
to a
void
adv
erse
effe
cts
on th
e en
viro
nmen
t hav
e be
en fo
llow
ed.
The fi e
lds
are
also
insp
ecte
d af
ter
the
tria
ls, i
n or
der
to p
reve
nt a
ny p
ossi
ble
gene
tran
sfer
fr
om tr
ansg
enic
vol
unte
er p
lant
s or
har
vest
res
idue
s to
oth
er o
rgan
ism
s. F
or fi
eld
tria
ls u
nder
fl e
xibi
lizac
ión
CO
NA
BIA
will
onl
y re
com
men
d th
at in
spec
tions
be
mad
e at
har
vest
and
of
the
mea
sure
s ta
ken
for
the fi n
al d
ispo
sitio
n of
the
mat
eria
l.
• A
t the
end
of t
he p
erio
d fo
r w
hich
the
auth
oris
atio
n w
as g
rant
ed, t
he a
pplic
ant m
ust s
ubm
it to
C
ON
AB
IA a
fi na
l rep
ort.
CO
NA
BIA
will
not
eva
luat
e an
y fu
rthe
r ap
plic
atio
n fr
om a
pub
lic o
r pr
ivat
e in
stitu
tion
whi
ch h
ad fa
iled
to p
rese
nt a
fi na
l rep
ort.
Appendix 8
212
Statutory Review of the Gene Technology Act 2000
Pena
lties
•
Not
kno
wn
at th
is s
tage
.
Liab
ility
for
cont
amin
atio
n•
Th
ere
is n
o m
entio
n of
liab
ility
for
cont
amin
atio
n.
Polic
y an
d G
over
nanc
e is
sues
Expe
rt c
omm
ittee
s•
CO
NA
BIA
is a
mul
tidis
cipl
inar
y an
d in
ter-
inst
itutio
nal g
roup
who
se m
embe
rs a
re
repr
esen
tativ
es o
f the
pub
lic a
nd p
rivat
e se
ctor
s w
orki
ng in
Agr
icul
tura
l Bio
tech
nolo
gy.
Res
earc
h•
CO
NA
BIA
req
uest
s th
at a
pplic
ants
per
form
res
earc
h bu
t doe
s no
t con
duct
the
rese
arch
.
Oth
er
The
prec
autio
nary
pr
inci
ple
• T
he w
hole
dep
artm
ent o
pera
tes
unde
r th
e 19
92 R
io D
ecla
ratio
n on
Env
iron
men
t and
D
evel
opm
ent v
ersi
on o
f the
pre
caut
iona
ry p
rinc
iple
.
Cos
t rec
over
y•
Not
app
licab
le.
Prot
ectio
n of
con
fi den
tial
com
mer
cial
info
rmat
ion
• P
arts
of a
pplic
atio
ns th
at c
onta
in tr
ade
secr
ets
or c
onfi d
entia
l inf
orm
atio
n ar
e pr
otec
ted.
• T
here
is n
o da
ta e
xclu
sivi
ty.
Mor
ator
ium
• N
ot a
pplic
able
.
Oth
er
213
and the Gene Technology Agreement
RE
GU
LA
TIO
N O
F G
EN
E T
EC
HN
OL
OG
Y I
N C
HIN
A
SUM
MA
RY —
The
Min
istr
y of
Agr
icul
ture
app
ears
to b
e m
ainl
y re
spon
sibl
e fo
r th
e fo
rmul
atio
n an
d im
plem
enta
tion
of
regu
latio
ns in
rel
atio
n to
bio
tech
nolo
gy a
nd b
iosa
fety
.
• O
ther
inte
rest
ed g
over
nmen
t age
ncie
s in
clud
e th
e St
ate
Envi
ronm
enta
l Pro
tect
ion
Age
ncy,
the
Min
istr
y of
Pub
lic H
ealth
, th
e In
spec
tion
and
Qua
rant
ine
Age
ncy,
the
Min
istr
y of
For
eign
Eco
nom
y an
d Tr
ade
and
the
Min
istr
y of
Sci
ence
s an
d Te
chno
logi
es.
• A
ll th
ese
agen
cies
’ vie
ws
are
repr
esen
ted
on S
tate
Min
iste
rial
Cou
ncil.
• D
ay-t
o-da
y re
gula
tion
of G
MO
s is
adm
inis
tere
d by
the
Offi
ce o
f Agr
icul
tura
l Gen
etic
Eng
inee
ring
Bio
safe
ty A
dmin
istr
atio
n.
How
ever
, in
late
200
5, th
e C
hine
se G
over
nmen
t for
med
a n
ew b
ody
to a
dmin
iste
r G
MO
reg
ulat
ion.
• T
he M
inis
try
of P
ublic
Hea
lth is
res
pons
ible
for
food
saf
ety
in r
elat
ion
to G
MO
s in
tend
ed fo
r th
at p
urpo
se.
• T
he M
inis
try
for
Scie
nces
and
Tec
hnol
ogie
s is
res
pons
ible
for
biot
echn
olog
y re
sear
ch.
• G
enet
ic e
ngin
eeri
ng w
ork
is c
lass
ifi ed
into
four
cla
sses
of r
isk
to h
uman
hea
lth a
nd e
colo
gica
l env
iron
men
t: n
one;
low
; in
term
edia
te; a
nd h
igh.
• T
he r
isk
clas
sifi c
atio
n is
det
erm
ined
by
the
rele
vant
age
ncie
s on
the
Stat
e M
inis
teri
al C
ounc
il.
Con
tain
ed w
ork
wit
h G
MO
s
Res
pons
ible
age
ncy
• T
his
may
dep
end
on th
e cl
assifi e
d le
vel o
f ris
k fo
r th
e ty
pe o
f wor
k be
ing
done
, but
gen
eral
ly n
o or
lo
w r
isk,
con
tain
ed e
xper
imen
tal w
ork
wou
ld n
orm
ally
req
uire
app
rova
l fro
m th
e ad
min
istr
atio
n of
the
inst
itutio
n in
whi
ch th
e w
ork
is c
ondu
cted
. H
owev
er, h
ighe
r ri
sk w
ork
requ
ires
add
ition
al
appr
oval
from
the
rele
vant
dep
artm
ents
und
er th
e St
ate
Cou
ncil
and
the
Nat
iona
l Gen
etic
En
gine
erin
g Sa
fety
Com
mitt
ee.
Legi
slat
ion
• S
afet
y A
dmin
istr
atio
n an
d R
egul
atio
n on
Gen
etic
Eng
inee
ring
Reg
ulat
ions
(199
3).
Appendix 8
214
Statutory Review of the Gene Technology Act 2000
Ass
essm
ent p
roce
ss
for
cont
aine
d w
ork
invo
lvin
g G
MO
s
• I
nstit
utio
ns c
arry
ing
out g
enet
ic e
xper
imen
tal r
esea
rch
shou
ld c
ondu
ct e
valu
atio
n on
DN
A d
onor
s,
vect
ors,
hos
ts a
nd g
enet
ic e
ngin
eere
d or
gani
sms.
Fac
tors
con
side
red
shou
ld in
clud
e pa
thog
enic
ity,
carc
inog
enic
ity, c
hem
ical
res
ista
nce,
tran
sfer
pos
sibi
lity,
and
effe
cts
on e
nvir
onm
ent o
f tar
get g
enes
, ve
ctor
s, h
osts
and
gen
etic
ally
eng
inee
red
orga
nism
s, a
nd o
n de
term
inin
g bi
olog
ical
con
trol
and
ph
ysic
al c
ontr
ol c
lass
es.
• F
or in
term
edia
te r
isk
wor
k, th
e in
stitu
tion’
s ad
min
istr
atio
n sh
ould
con
side
r th
e ap
plic
atio
n an
d th
en
subm
it th
e ap
plic
atio
n to
the
rele
vant
dep
artm
ents
und
er th
e St
ate
Cou
ncil
for
cons
ider
atio
n. F
or
high
ris
k w
ork,
the
appl
icat
ion
is s
ubm
itted
to th
e N
atio
nal G
enet
ic E
ngin
eeri
ng S
afet
y C
omm
ittee
fo
r ap
prov
al a
fter
bein
g su
bmitt
ed to
the
rele
vant
dep
artm
ent u
nder
the
Stat
e C
ounc
il.
• I
nstit
utio
ns c
arry
ing
out g
enet
ic e
ngin
eeri
ng w
ork
shou
ld g
o th
roug
h th
e fo
llow
ing
appl
icat
ion
proc
edur
es:
the
chie
f of t
he p
lann
ed g
enet
ic e
ngin
eeri
ng p
roje
ct s
houl
d ev
alua
te th
e sa
fety
of t
he
proj
ect a
nd fi
ll in
the
appl
icat
ion
form
; the
aca
dem
ic c
omm
ittee
of t
he in
stitu
tion
shou
ld c
ondu
ct
tech
nica
l eva
luat
ion
on th
e ap
plic
atio
n; a
pplic
atio
ns s
houl
d be
sub
mitt
ed a
long
with
tech
nica
l do
cum
enta
tion.
• S
afet
y m
easu
res
incl
ude:
dev
elop
men
t of s
afet
y co
ntro
l mea
sure
s ap
prop
riat
e fo
r th
e cl
ass
of r
isk;
w
aste
man
agem
ent p
roce
dure
s (G
MO
s sh
ould
be
kille
d an
d di
spos
ed o
f to
prev
ent d
isse
min
atio
n an
d en
viro
nmen
tal p
ollu
tion)
; dev
elop
men
t of m
easu
res
to p
reve
nt a
ccid
ents
; app
ropr
iate
sto
rage
an
d tr
ansp
orta
tion
prov
isio
ns; m
aint
aini
ng a
wri
tten
safe
ty c
ontr
ol r
ecor
d fo
r a
min
imum
of t
en
year
s; r
equi
rem
ent f
or in
stitu
tions
taki
ng im
med
iate
mea
sure
s to
res
tric
t and
alle
viat
e ha
rm if
it is
di
scov
ered
that
the
inst
itutio
n’s
wor
k is
cau
sing
env
iron
men
tal d
amag
e or
har
m.
Con
side
ratio
n of
et
hica
l iss
ues
• T
here
was
no
spec
ifi c
requ
irem
ent f
or e
thic
al is
sues
to b
e co
nsid
ered
.
Publ
ic c
onsu
ltatio
n on
app
licat
ions
• T
here
was
no
spec
ifi c
men
tion
for
the
requ
irem
ent f
or p
ublic
con
sulta
tion.
215
and the Gene Technology Agreement
Con
ditio
ns th
at m
ay
be a
pplie
d•
No
spec
ifi c
men
tion
of th
e co
nditi
ons
to b
e ap
plie
d w
ere
men
tione
d, b
ut r
elev
ant a
dmin
istr
ativ
e de
part
men
ts w
ill is
sue
war
ning
s, s
top
oper
atio
n, s
uspe
nd fi
nanc
ial s
uppo
rt, c
onfi s
cate
ille
gal p
rofi t
s ac
cord
ing
to a
ctua
l con
ditio
ns o
f vio
latio
ns.
Mon
itori
ng,
surv
eilla
nce
and
enfo
rcem
ent p
ower
s
• L
aws
and
regu
latio
ns in
trod
uced
in 2
002
and
2003
con
tain
pro
visi
ons
for
mon
itori
ng a
nd
surv
eilla
nce
to e
nsur
e en
viro
nmen
tal s
afet
y fr
om u
se o
f GM
Os.
Pena
lties
• R
elev
ant a
dmin
istr
ativ
e de
part
men
ts w
ill is
sue
war
ning
s, s
top
oper
atio
n, s
uspe
nd fi
nanc
ial s
uppo
rt,
confi
sca
te il
lega
l profi t
s ac
cord
ing
to a
ctua
l con
ditio
ns o
f vio
latio
n w
hen:
the
gen
etic
eng
inee
ring
pr
ojec
t beg
ins
oper
atio
n w
ithou
t app
rova
l; eq
uipm
ent,
appa
ratu
s, la
bora
tori
es w
hich
do
not fi
t in
w
ith r
egul
atio
ns h
ave
been
use
d; v
iola
tion
of s
afet
y op
erat
ion
regu
latio
ns o
f gen
etic
eng
inee
ring
w
ork
has
occu
rred
; vio
latio
n of
oth
er r
ules
und
er th
e re
gula
tions
occ
ur.
• B
oth
indi
vidu
als
and
the
inst
itutio
n co
nduc
ting
the
wor
k ca
n be
liab
le fo
r an
y da
mag
es r
esul
ting
from
the
wor
k.
• R
espo
nsib
le in
stitu
tions
of t
hose
vio
latin
g an
y re
leva
nt le
gisl
atio
n an
d ca
usin
g on
e of
the
follo
win
g re
sults
mus
t im
med
iate
ly s
top
the
viol
atio
n an
d ta
ke m
easu
res
to h
andl
e th
e po
llutio
n an
d co
mpe
nsat
e fo
r lo
sses
: ca
usin
g se
riou
s en
viro
nmen
t pol
lutio
n; c
ausi
ng d
amag
e or
har
m to
the
publ
ic h
ealth
; cau
sing
sev
ere
dam
age
to e
colo
gica
l res
ourc
es a
nd e
colo
gica
l bal
ance
. C
rim
inal
ch
arge
s ca
n al
so b
e la
id s
ubje
ct to
the
appr
opri
ate
legi
slat
ion.
Inte
ntio
nal r
elea
ses
of G
MO
s in
the
env
iron
men
t
Res
pons
ible
age
ncy
• D
epar
tmen
ts u
nder
the
Stat
e C
ounc
il; D
epar
tmen
t of A
gric
ultu
re; D
epar
tmen
t of S
cien
ce a
nd
Tech
nolo
gy; S
tate
Env
iron
men
tal P
rote
ctio
n A
dmin
istr
atio
n; N
atio
nal G
enet
ic E
ngin
eeri
ng
Safe
ty C
omm
ittee
.
Appendix 8
216
Statutory Review of the Gene Technology Act 2000
Legi
slat
ion
• S
afet
y A
dmin
istr
atio
n an
d R
egul
atio
n on
Gen
etic
Eng
inee
ring
Reg
ulat
ions
(199
3).
• R
egul
atio
ns o
n A
dmin
istr
atio
n of
Agr
icul
tura
l GM
Os
Safe
ty (2
001)
.
Cov
erag
e of
the
legi
slat
ion
Ass
essm
ent p
roce
ss
for
inte
ntio
nal
rele
ases
of a
G
MO
into
the
envi
ronm
ent (fi e
ld
tria
ls a
nd g
ener
al
rele
ases
)
• I
nstit
utio
ns c
arry
ing
out g
enet
ic e
ngin
eeri
ng p
ilot e
xper
imen
ts o
r in
dust
rial
pro
duct
ion
shou
ld
cond
uct s
afet
y ev
alua
tion
on th
e ph
ysic
al b
arri
ers
of th
e eq
uipm
ent a
nd fa
cilit
ies
of th
e cu
lture
, fe
rmen
tatio
n, s
epar
atio
n an
d pu
rifi c
atio
n pr
oces
ses
acco
rdin
g to
gen
etic
eng
inee
red
orga
nism
s sa
fety
cla
ss, t
o de
term
ine
the
safe
ty c
lass
of p
ilot e
xper
imen
ts o
r in
dust
rial
pro
duct
ion.
• I
nstit
utio
ns c
arry
ing
out t
he re
leas
e of
gen
etic
eng
inee
red
orga
nism
s sh
ould
con
duct
eva
luat
ion
on th
e sa
fety
of g
enet
ic e
ngin
eere
d or
gani
sms,
the
purp
ose
of th
e re
leas
e, e
colo
gica
l env
ironm
ent c
ondi
tions
of
the
rele
ase
site
, rel
easi
ng m
etho
ds, m
onito
ring
mea
ns a
nd c
ontro
l mea
sure
s, to
det
erm
ine
the
safe
ty c
lass
of t
he re
leas
e. A
ppro
val f
or w
ork
clas
sifi e
d as
no
risk
shou
ld b
e ob
tain
ed fr
om th
e ch
ief
adm
inis
trato
rs o
f the
inst
itutio
n; a
ppro
val f
or w
ork
clas
sifi e
d as
low
risk
requ
ires
appr
oval
by
rele
vant
St
ate
Cou
ncil
depa
rtmen
ts; i
nter
med
iate
risk
wor
k al
so re
quire
s ap
prov
al fr
om re
leva
nt S
tate
Cou
ncil
depa
rtmen
ts w
ith th
e ap
plic
atio
n re
cord
ed b
y th
e N
atio
nal G
enet
ic E
ngin
eerin
g Sa
fety
Com
mitt
ee;
appl
icat
ions
for h
igh
risk
wor
k is
exa
min
ed b
y th
e re
leva
nt S
tate
Cou
ncil
depa
rtmen
ts a
nd s
ubm
itted
fo
r app
rova
l to
the
Nat
iona
l Gen
etic
Eng
inee
ring
Safe
ty C
omm
ittee
.
• I
nstit
utio
ns c
arry
ing
out g
enet
ic e
ngin
eeri
ng w
ork
shou
ld g
o th
roug
h th
e fo
llow
ing
appl
icat
ion
proc
edur
es:
the
chie
f of t
he p
lann
ed g
enet
ic e
ngin
eeri
ng p
roje
ct s
houl
d ev
alua
te th
e sa
fety
of
the
proj
ect a
nd fi
ll in
the
appl
icat
ion
form
; the
aca
dem
ic c
omm
ittee
of t
he in
stitu
tion
shou
ld
cond
uct t
echn
ical
eva
luat
ion
on th
e ap
plic
atio
n; a
pplic
atio
ns s
houl
d be
sub
mitt
ed a
long
with
te
chni
cal d
ocum
enta
tion.
217
and the Gene Technology Agreement
Ass
essm
ent p
roce
ss
for
inte
ntio
nal
rele
ases
of a
G
MO
into
the
envi
ronm
ent (fi e
ld
tria
ls a
nd g
ener
al
rele
ases
) (co
ntin
ued)
• S
afet
y m
easu
res
incl
ude:
dev
elop
men
t of s
afet
y co
ntro
l mea
sure
s ap
prop
riat
e fo
r th
e cl
ass
of r
isk;
w
aste
man
agem
ent p
roce
dure
s (G
MO
s sh
ould
be
kille
d an
d di
spos
ed o
f to
prev
ent d
isse
min
atio
n an
d en
viro
nmen
tal p
ollu
tion)
; dev
elop
men
t of m
easu
res
to p
reve
nt a
ccid
ents
; app
ropr
iate
sto
rage
an
d tr
ansp
orta
tion
prov
isio
ns; m
aint
aini
ng a
wri
tten
safe
ty c
ontr
ol r
ecor
d fo
r a
min
imum
of t
en
year
s; r
equi
rem
ent f
or in
stitu
tions
taki
ng im
med
iate
mea
sure
s to
res
tric
t and
alle
viat
e ha
rm if
it is
di
scov
ered
that
the
inst
itutio
n’s
wor
k is
cau
sing
env
iron
men
tal d
amag
e or
har
m.
Con
side
ratio
n of
et
hica
l iss
ues
• T
here
was
no
spec
ifi c
requ
irem
ent f
or e
thic
al is
sues
to b
e co
nsid
ered
.
Publ
ic c
onsu
ltatio
n on
app
licat
ions
• T
here
was
no
spec
ifi c
men
tion
for
the
requ
irem
ent f
or p
ublic
con
sulta
tion.
Con
ditio
ns th
at m
ay
be a
pplie
d•
No
spec
ifi c
men
tion
of th
e co
nditi
ons
to b
e ap
plie
d w
ere
men
tione
d, b
ut r
elev
ant a
dmin
istr
ativ
e de
part
men
ts w
ill is
sue
war
ning
s, s
top
oper
atio
n, s
uspe
nd fi
nanc
ial s
uppo
rt, c
onfi s
cate
ille
gal p
rofi t
s ac
cord
ing
to a
ctua
l con
ditio
ns o
f vio
latio
ns.
Mon
itori
ng,
surv
eilla
nce
and
enfo
rcem
ent p
ower
s
• L
aws
and
regu
latio
ns in
trod
uced
in 2
002
and
2003
con
tain
pro
visi
ons
for
mon
itori
ng a
nd
surv
eilla
nce
to e
nsur
e en
viro
nmen
tal s
afet
y fr
om u
se o
f GM
Os.
Appendix 8
218
Statutory Review of the Gene Technology Act 2000
Pena
lties
• R
elev
ant a
dmin
istr
ativ
e de
part
men
ts w
ill is
sue
war
ning
s, s
top
oper
atio
n, s
uspe
nd fi
nanc
ial s
uppo
rt,
confi
sca
te il
lega
l profi t
s ac
cord
ing
to a
ctua
l con
ditio
ns o
f vio
latio
n w
hen:
the
gene
tic e
ngin
eeri
ng
proj
ect b
egin
s op
erat
ion
with
out a
ppro
val;
equi
pmen
t, ap
para
tus,
labo
rato
ries
whi
ch d
o no
t fi t
in
with
reg
ulat
ions
hav
e be
en u
sed;
vio
latio
n of
saf
ety
oper
atio
n re
gula
tions
of g
enet
ic e
ngin
eeri
ng
wor
k ha
s oc
curr
ed; v
iola
tion
of o
ther
rul
es u
nder
the
regu
latio
ns o
ccur
.
• B
oth
indi
vidu
als
and
the
inst
itutio
n co
nduc
ting
the
wor
k ca
n be
liab
le fo
r an
y da
mag
es r
esul
ting
from
the
wor
k.
• R
espo
nsib
le in
stitu
tions
of t
hose
vio
latin
g an
y re
leva
nt le
gisl
atio
n an
d ca
usin
g on
e of
the
follo
win
g re
sults
mus
t im
med
iate
ly s
top
the
viol
atio
n an
d ta
ke m
easu
res
to h
andl
e th
e po
llutio
n an
d co
mpe
nsat
e fo
r lo
sses
: ca
usin
g se
riou
s en
viro
nmen
t pol
lutio
n; c
ausi
ng d
amag
e or
har
m to
the
publ
ic h
ealth
; cau
sing
sev
ere
dam
age
to e
colo
gica
l res
ourc
es a
nd e
colo
gica
l bal
ance
. C
rim
inal
ch
arge
s ca
n al
so b
e la
id s
ubje
ct to
the
appr
opri
ate
legi
slat
ion.
Ass
essm
ent
proc
ess
for
inte
ntio
nal r
elea
ses
of a
GM
O fo
r co
mm
erci
alis
atio
n
• U
se o
f fi n
ishe
d ge
netic
eng
inee
ring
pro
duct
s (in
tend
ed fo
r re
leas
e) s
houl
d be
acc
ompa
nied
by
biol
ogic
al te
sts
for
the
purp
oses
of a
saf
ety
eval
uatio
n, w
hich
will
det
erm
ine
the
poss
ible
impa
ct o
f th
e pr
oduc
t on
the
publ
ic h
ealth
and
the
ecol
ogic
al e
nvir
onm
ent.
• F
or w
ork
clas
sifi e
d be
twee
n no
ris
k an
d in
term
edia
te r
isk,
app
licat
ions
sho
uld
be s
ubm
itted
to th
e re
leva
nt d
epar
tmen
ts u
nder
the
Stat
e C
ounc
il fo
r ap
prov
al a
nd to
the
Nat
iona
l Gen
etic
Eng
inee
ring
Sa
fety
Com
mitt
ee fo
r th
eir
reco
rd.
• F
or r
elea
ses
clas
sifi e
d as
hig
h ri
sk, t
he a
pplic
atio
n sh
ould
be
exam
ined
by
the
rele
vant
de
part
men
ts u
nder
the
Stat
e C
ounc
il an
d su
bmitt
ed to
the
Nat
iona
l Gen
etic
Eng
inee
ring
Saf
ety
Com
mitt
ee fo
r ap
prov
al.
219
and the Gene Technology Agreement
Ass
essm
ent
proc
ess
for
inte
ntio
nal r
elea
ses
of a
GM
O fo
r co
mm
erci
alis
atio
n
• In
stitu
tions
car
ryin
g ou
t gen
etic
eng
inee
ring
wor
k sh
ould
go
thro
ugh
the
follo
win
g ap
plic
atio
n pr
oced
ures
: th
e ch
ief o
f the
pla
nned
gen
etic
eng
inee
ring
proj
ect s
houl
d ev
alua
te th
e sa
fety
of t
he p
roje
ct
and fi l
l in
the
appl
icat
ion
form
; the
aca
dem
ic c
omm
ittee
of t
he in
stitu
tion
shou
ld c
ondu
ct te
chni
cal
eval
uatio
n on
the
appl
icat
ion;
app
licat
ions
sho
uld
be s
ubm
itted
alo
ng w
ith te
chni
cal d
ocum
enta
tion.
• S
afet
y m
easu
res
incl
ude:
dev
elop
men
t of s
afet
y co
ntro
l mea
sure
s ap
prop
riat
e fo
r th
e cl
ass
of r
isk;
w
aste
man
agem
ent p
roce
dure
s (G
MO
s sh
ould
be
kille
d an
d di
spos
ed o
f to
prev
ent d
isse
min
atio
n an
d en
viro
nmen
tal p
ollu
tion)
; dev
elop
men
t of m
easu
res
to p
reve
nt a
ccid
ents
; app
ropr
iate
sto
rage
an
d tr
ansp
orta
tion
prov
isio
ns; m
aint
aini
ng a
wri
tten
safe
ty c
ontr
ol r
ecor
d fo
r a
min
imum
of t
en
year
s; r
equi
rem
ent f
or in
stitu
tions
taki
ng im
med
iate
mea
sure
s to
res
tric
t and
alle
viat
e ha
rm if
it is
di
scov
ered
that
the
inst
itutio
n’s
wor
k is
cau
sing
env
iron
men
tal d
amag
e or
har
m.
Con
side
ratio
n of
et
hica
l iss
ues
• T
here
was
no
spec
ifi c
requ
irem
ent f
or e
thic
al is
sues
to b
e co
nsid
ered
.
Publ
ic c
onsu
ltatio
n on
app
licat
ions
• T
here
was
no
spec
ifi c
men
tion
for
the
requ
irem
ent f
or p
ublic
con
sulta
tion.
Con
ditio
ns th
at m
ay
be a
pplie
d•
No
spec
ifi c
men
tion
of th
e co
nditi
ons
to b
e ap
plie
d w
ere
men
tione
d, b
ut r
elev
ant a
dmin
istr
ativ
e de
part
men
ts w
ill is
sue
war
ning
s, s
top
oper
atio
n, s
uspe
nd fi
nanc
ial s
uppo
rt, c
onfi s
cate
ille
gal p
rofi t
s ac
cord
ing
to a
ctua
l con
ditio
ns o
f vio
latio
ns.
Mon
itori
ng,
surv
eilla
nce
and
enfo
rcem
ent p
ower
s
• L
aws
and
regu
latio
ns in
trod
uced
in 2
002
and
2003
con
tain
pro
visi
ons
for
mon
itori
ng a
nd
surv
eilla
nce
to e
nsur
e en
viro
nmen
tal s
afet
y fr
om u
se o
f GM
Os.
220
Statutory Review of the Gene Technology Act 2000
Pena
lties
• R
elev
ant a
dmin
istr
ativ
e de
part
men
ts w
ill is
sue
war
ning
s, s
top
oper
atio
n, s
uspe
nd fi
nanc
ial s
uppo
rt,
confi
sca
te il
lega
l profi t
s ac
cord
ing
to a
ctua
l con
ditio
ns o
f vio
latio
n w
hen:
the
gen
etic
eng
inee
ring
pr
ojec
t beg
ins
oper
atio
n w
ithou
t app
rova
l; eq
uipm
ent,
appa
ratu
s, la
bora
tori
es w
hich
do
not fi
t in
w
ith r
egul
atio
ns h
ave
been
use
d; v
iola
tion
of s
afet
y op
erat
ion
regu
latio
ns o
f gen
etic
eng
inee
ring
w
ork
has
occu
rred
; vio
latio
n of
oth
er r
ules
und
er th
e re
gula
tions
occ
ur.
• B
oth
indi
vidu
als
and
the
inst
itutio
n co
nduc
ting
the
wor
k ca
n be
liab
le fo
r an
y da
mag
es r
esul
ting
from
the
wor
k.
• I
nstit
utio
ns r
espo
nsib
le fo
r vi
olat
ing
any
rele
vant
legi
slat
ion
and
caus
ing
one
of th
e fo
llow
ing
resu
lts
mus
t im
med
iate
ly s
top
the
viol
atio
n an
d ta
ke m
easu
res
to h
andl
e th
e po
llutio
n an
d co
mpe
nsat
e fo
r lo
sses
: ca
usin
g se
riou
s en
viro
nmen
t pol
lutio
n; c
ausi
ng d
amag
e or
har
m to
the
publ
ic h
ealth
; ca
usin
g se
vere
dam
age
to e
colo
gica
l res
ourc
es a
nd e
colo
gica
l bal
ance
. C
rim
inal
cha
rges
can
als
o be
laid
sub
ject
to th
e ap
prop
riat
e le
gisl
atio
n.
Polic
y an
d G
over
nanc
e is
sues
Liab
ility
for
cont
amin
atio
n•
Ins
titut
ions
are
res
pons
ible
for
any
clea
n-up
req
uire
men
ts a
nd p
rovi
ding
com
pens
atio
n fo
r lo
sses
.
• C
rim
inal
cha
rges
can
als
o be
laid
sub
ject
to th
e ap
prop
riat
e le
gisl
atio
n.
Expe
rt c
omm
ittee
s•
Nat
iona
l Gen
etic
Eng
inee
ring
Saf
ety
Com
mitt
ee.
• N
atio
nal A
gric
ultu
ral G
MO
Bio
safe
ty C
omm
ittee
par
ticip
ates
in b
iosa
fety
man
agem
ent.
Res
earc
h•
At t
he n
atio
nal l
evel
, the
Min
istr
y of
Agr
icul
ture
, the
Chi
nese
Aca
dem
y of
Sci
ence
s, th
e St
ate
Fore
stry
Bur
eau
and
the
Min
istr
y of
Edu
catio
n ar
e th
e m
ajor
aut
hori
ties
resp
onsi
ble
for
agri
cultu
ral
biot
echn
olog
y re
sear
ch.
• U
nder
the
Min
istr
y of
Agr
icul
ture
, the
re a
re th
ree
larg
e ac
adem
ies:
the
Chi
nese
Aca
dem
y of
A
gric
ultu
ral S
cien
ces;
the
Chi
nese
Aca
dem
y of
Tro
pica
l Agr
icul
ture
; and
the
Chi
nese
Aca
dem
y of
Fi
sher
ies.
221
and the Gene Technology Agreement
Oth
er
The
prec
autio
nary
pr
inci
ple
• N
o sp
ecifi
c m
entio
n of
the
prec
autio
nary
pri
ncip
le w
as fo
und
in a
ny o
f the
info
rmat
ion
foun
d on
th
e C
hine
se g
ene
tech
nolo
gy r
egul
atio
n re
gim
e.
Cos
t rec
over
y•
Ins
titut
ions
who
se w
ork
with
GM
Os
has
caus
ed e
nvir
onm
enta
l dam
age
are
resp
onsi
ble
for
taki
ng
rem
edia
l act
ion
and
for
com
pens
atio
n co
sts.
Prot
ectio
n of
co
nfi d
entia
l co
mm
erci
al
info
rmat
ion
N
o re
fere
nce
was
foun
d to
this
.
Mor
ator
ium
N
o sp
ecifi
c m
entio
n of
a m
orat
oriu
m w
as fo
und;
how
ever
, Chi
na in
trod
uced
mor
e re
stri
ctiv
e bi
osaf
ety
regu
latio
ns in
200
2.
Oth
er•
Chi
na h
as r
atifi
ed th
e C
arte
gena
pro
toco
l on
bios
afet
y.
• A
s of
200
3, C
hina
was
in th
e pr
oces
s of
intr
oduc
ing
new
/upd
atin
g ex
istin
g la
ws
and
regu
latio
ns
gove
rnin
g w
ork
invo
lvin
g G
MO
s. T
he in
form
atio
n in
this
tabl
e m
ay s
oon
be s
uper
sede
d.
• G
M la
belli
ng g
uide
lines
took
effe
ct fr
om 2
002.
• I
nfor
mat
ion
was
sou
rced
from
http
://w
ww
.ebn
ic.o
rg (h
ttp://
ww
w.e
bnic
.org
/det
ails
c.ht
m#h
apte
r%20
Tw
o:%
20Sa
fety
%20
Cla
sses
%20
and%
20Sa
fety
%20
Eval
uatio
n) a
nd h
ttp://
ww
w.c
hina
.org
.cn/
engl
ish.
In
stitu
te o
f Dev
elop
men
tal S
tudi
es w
orki
ng p
aper
195
, Jik
un H
uang
and
Qin
fang
Wan
g,
Bio
tech
nolo
gy p
olic
y an
d re
gula
tion
in C
hina
(200
3).
Appendix 8
