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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.
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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
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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.
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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
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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.
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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
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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.
![Page 8: Statutory Review of the Gene Tec hnology Act 2000 · 2019-12-03 · 180 Statutory Review of the Gene Tec hnology Act 2000 Assessment process for intentional release of a GMO into](https://reader034.vdocuments.site/reader034/viewer/2022042303/5ece51e7b6177848982ae533/html5/thumbnails/8.jpg)
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
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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.
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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
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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.
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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
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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.
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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.
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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.
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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
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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).
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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
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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.
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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
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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.
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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
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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.
![Page 24: Statutory Review of the Gene Tec hnology Act 2000 · 2019-12-03 · 180 Statutory Review of the Gene Tec hnology Act 2000 Assessment process for intentional release of a GMO into](https://reader034.vdocuments.site/reader034/viewer/2022042303/5ece51e7b6177848982ae533/html5/thumbnails/24.jpg)
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
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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.
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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
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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.
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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
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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.
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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
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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.
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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
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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.
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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
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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
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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
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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.
![Page 38: Statutory Review of the Gene Tec hnology Act 2000 · 2019-12-03 · 180 Statutory Review of the Gene Tec hnology Act 2000 Assessment process for intentional release of a GMO into](https://reader034.vdocuments.site/reader034/viewer/2022042303/5ece51e7b6177848982ae533/html5/thumbnails/38.jpg)
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
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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.
![Page 40: Statutory Review of the Gene Tec hnology Act 2000 · 2019-12-03 · 180 Statutory Review of the Gene Tec hnology Act 2000 Assessment process for intentional release of a GMO into](https://reader034.vdocuments.site/reader034/viewer/2022042303/5ece51e7b6177848982ae533/html5/thumbnails/40.jpg)
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
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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.
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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.
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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.
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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