178

Statutory Review of the Gene Technology Act 2000

SUM

MA

RY —

con

tinue

d

• T

he E

cono

mic

Res

earc

h Se

rvic

e (E

RS)

con

duct

s re

sear

ch o

n th

e ec

onom

ic a

spec

ts o

f the

use

of g

enet

ical

ly e

ngin

eere

d or

gani

sms,

incl

udin

g th

e ra

te o

f and

rea

sons

for

adop

tion

of b

iote

chno

logy

by

farm

ers.

• T

he F

ood

Safe

ty a

nd In

spec

tion

Serv

ice

(FSI

S) is

the

publ

ic h

ealth

age

ncy

in th

e U

.S. D

epar

tmen

t of A

gric

ultu

re r

espo

nsib

le

for

ensu

ring

that

the

natio

n’s

com

mer

cial

sup

ply

of m

eat,

poul

try,

and

egg

pro

duct

s is

saf

e, w

hole

som

e, a

nd c

orre

ctly

la

belle

d an

d pa

ckag

ed in

clud

ing

anim

als

invo

lved

in b

iote

chno

logy

.

• T

he N

atio

nal A

gric

ultu

ral S

tatis

tics

Serv

ice

(NA

SS),

as th

e fa

ct fi

nder

for

agri

cultu

re, p

rovi

des

info

rmat

ion

on th

e ad

optio

n of

bi

otec

hnol

ogy

crop

s (s

pecifi c

ally

cor

n, c

otto

n, a

nd s

oybe

ans)

.

Con

tain

ed w

ork

wit

h G

MO

s

Res

pons

ible

age

ncy

• N

atio

nal I

nstit

ute

of H

ealth

(NIH

).

Legi

slat

ion

• T

here

is n

o sp

ecia

l reg

ulat

ory

syst

em fo

r en

suri

ng th

e sa

fe u

se o

f bio

tech

nolo

gy in

the

labo

rato

ry o

r fa

ctor

y w

here

the

orga

nism

is n

ot to

be

rele

ased

into

the

envi

ronm

ent (

i.e.

cont

aine

d us

e). V

olun

tary

gui

delin

es —

the

NIH

’s G

uide

lines

for

Res

earc

h In

volv

ing

Rec

ombi

nant

DN

A M

olec

ules

— a

re im

plem

ente

d by

mos

t use

rs o

f the

tech

nolo

gy.

Inte

ntio

nal r

elea

ses

of G

MO

s in

the

env

iron

men

t

Res

pons

ible

age

ncy

• T

he U

S D

epar

tmen

t of A

gric

ultu

re A

nim

al a

nd P

lant

Hea

lth In

spec

tion

Serv

ice

(for

plan

t pe

sts,

pla

nts

and

vete

rina

ry b

iolo

gics

).

• T

he U

.S. E

nvir

onm

enta

l Pro

tect

ion

Age

ncy

(for

mic

robi

al/p

lant

pes

ticid

es, n

ew u

ses

of

exis

ting

pest

icid

es a

nd n

ovel

mic

ro-o

rgan

ism

s).

Legi

slat

ion

• F

eder

al P

lant

Pes

t Act

; Fed

eral

Inse

ctic

ide,

Fun

gici

de a

nd R

oden

ticid

e A

ct; N

atio

nal

Envi

ronm

ent P

olic

y A

ct; P

lant

Pro

tect

ion

Act

; Fed

eral

Foo

d, D

rug

and

Cos

met

ic A

ct; F

ood

Qua

lity

Prot

ectio

n A

ct; E

ndan

gere

d Sp

ecie

s A

ct.

179

and the Gene Technology Agreement

Cov

erag

e of

the

legi

slat

ion

• F

ield

test

ing,

mov

ing,

impo

rtin

g an

d co

mm

erci

al r

elea

se o

f org

anis

ms

and

prod

ucts

alte

red

or p

rodu

ced

thro

ugh

gene

tic e

ngin

eeri

ng w

hich

are

pla

nt p

ests

or

may

bec

ome

plan

t pe

sts.

Und

er th

e Pl

ant P

rote

ctio

n A

ct, A

PHIS

reg

ulat

es p

lant

s th

at m

ay p

ose

such

a r

isk.

O

rgan

ism

s an

d pr

oduc

ts th

at a

re k

now

n or

sus

pect

ed to

be

plan

t pes

ts o

r to

pos

e a

plan

t pe

st r

isk,

incl

udin

g th

ose

that

hav

e be

en a

ltere

d or

pro

duce

d th

roug

h ge

netic

eng

inee

ring

ar

e ca

lle d

‘reg

ulat

ed a

rtic

les’

.

• I

nten

tiona

l con

fi ned

rel

ease

into

the

envi

ronm

ent o

f reg

ulat

ed a

rtic

les

requ

ire

notifi

cat

ion

to th

e re

leva

nt a

utho

rity

und

er th

e re

leva

nt le

gisl

atio

n.

• ‘

Gen

etic

eng

inee

ring

’ is

defi n

ed a

s th

e ge

netic

mod

ifi ca

tion

of o

rgan

ism

s by

rec

ombi

nant

D

NA

tech

niqu

es. T

here

is n

o de

fi niti

on o

f ‘re

com

bina

nt D

NA

tech

niqu

es’.

• T

he F

eder

al F

ood,

Dru

g an

d C

osm

etic

Act

, Foo

d Q

ualit

y Pr

otec

tion

Act

and

End

ange

red

Spec

ies

Act

are

als

o co

nsid

ered

by

the

EPA

whe

n ev

alua

ting

the

risk

s th

at b

iope

stic

ides

(in

clud

ing

thos

e th

at e

ither

are

, or

res

ult f

rom

, GM

Os

or G

M te

chni

ques

) may

pos

e to

the

envi

ronm

ent o

r hu

man

hea

lth.

• T

he F

eder

al F

ood,

Dru

g an

d C

osm

etic

Act

gov

erns

the

FDA

in a

sses

sing

the

safe

ty o

f foo

ds/

feed

s fro

m n

ovel

pla

nt v

arie

ties

(incl

udin

g ge

netic

ally

eng

inee

red

plan

ts);

the

Food

Qua

lity

Prot

ectio

n A

ct im

pose

s st

anda

rd to

lera

nces

for a

llow

able

leve

ls o

f pes

ticid

es in

food

; whe

reas

th

e En

dang

ered

Spe

cies

Act

ens

ures

that

any

pes

ticid

es (i

nclu

ding

thos

e de

rived

from

GM

Os

or te

chni

ques

) do

not p

ose

a ris

k to

end

ange

red

spec

ies.

Ass

essm

ent p

roce

ss fo

r in

tent

iona

l rel

ease

of a

GM

O

into

the

envi

ronm

ent (fi e

ld

tria

ls)

• T

he d

evel

oper

sub

mits

a n

otifi

catio

n to

the

APH

IS (n

otifi

catio

n to

APH

IS o

f an

envi

ronm

enta

l rel

ease

mus

t be

at le

ast 1

20 d

ays

prio

r to

rel

ease

, but

this

can

be

exte

nded

if

an e

nvir

onm

enta

l im

pact

sta

tem

ent i

s re

quir

ed in

add

ition

to a

n en

viro

nmen

tal r

isk

asse

ssm

ent,

and

in th

e ca

se th

at a

dditi

onal

info

rmat

ion

is s

ubse

quen

tly r

equi

red,

the

120

day

peri

od w

ill s

tart

upo

n th

e re

ceip

t of t

he a

dditi

onal

info

rmat

ion)

.

• D

ata

mus

t dem

onst

rate

that

the

plan

t is

safe

to r

elea

se a

nd is

not

itse

lf a

plan

t pes

t or

pote

ntia

l nox

ious

wee

d.

Appendix 8

180

Statutory Review of the Gene Technology Act 2000

Ass

essm

ent p

roce

ss fo

r in

tent

iona

l rel

ease

of a

GM

O

into

the

envi

ronm

ent (fi e

ld

tria

ls) (

cont

inue

d)

• T

he A

PHIS

con

duct

s an

ass

essm

ent.

APH

IS h

as a

two

tiere

d le

vel o

f ris

k —

low

er r

isk

GM

Os

(for

exam

ple,

pla

nts

that

are

alte

red

with

com

mon

agr

onom

ic tr

aits

suc

h as

pes

t or

herb

icid

e re

sist

ance

) nee

d on

ly b

e no

tifi e

d to

the

agen

cy, w

hile

oth

er r

elea

ses

that

pos

e an

ele

vate

d ri

sk (s

uch

as p

lant

s th

at p

rodu

ce p

harm

aceu

tical

or

indu

stri

al c

ompo

unds

and

G

MO

s ot

her

than

pla

nts)

req

uire

a p

erm

it.

• T

here

are

six

cri

teri

a th

at a

pla

nt h

as to

mee

t bef

ore

bein

g co

nsid

ered

by

APH

IS fo

r no

tifi c

atio

n: i

t is

eith

er c

orn,

cot

ton,

pot

ato,

soy

bean

, tob

acco

, tom

ato

or a

ny a

dditi

onal

pl

ant s

peci

es th

at B

RS

has

dete

rmin

ed m

ay b

e sa

fely

intr

oduc

ed; t

he in

trod

uced

gen

etic

m

ater

ial i

s st

ably

inte

grat

ed; t

he fu

nctio

n of

the

intr

oduc

ed g

enet

ic m

ater

ial i

s kn

own

and

its e

xpre

ssio

n in

the

regu

late

d ar

ticle

doe

s no

t res

ult i

n pl

ant d

isea

se; t

he in

trod

uced

ge

netic

mat

eria

l doe

s no

t (1)

cau

se th

e pr

oduc

tion

of a

n in

fect

ious

ent

ity, (

2) e

ncod

e su

bsta

nces

that

are

kno

wn

or li

kely

to b

e to

xic

to n

on-t

arge

t org

anis

ms

know

n or

like

ly to

fe

ed o

r liv

e on

the

plan

t spe

cies

, or

(3) e

ncod

e pr

oduc

ts in

tend

ed fo

r ph

arm

aceu

tical

use

; th

e in

trod

uced

gen

etic

seq

uenc

es d

eriv

ed fr

om p

lant

vir

uses

do

not p

ose

a si

gnifi

cant

ris

k of

the

crea

tion

of a

ny n

ew p

lant

vir

us; t

he p

lant

has

not

bee

n m

odifi

ed to

con

tain

cer

tain

ge

netic

mat

eria

l der

ived

from

an

anim

al o

r hu

man

pat

hoge

n.

• N

otifi

catio

ns a

re r

equi

red

to c

onta

in:

spec

ifi c

info

rmat

ion

on th

e ge

netic

trai

t int

rodu

ced,

in

clud

ing

its o

rigi

ns; h

ow th

e ex

pres

sion

of t

he tr

ait d

iffer

s to

the

non-

mod

ifi ed

cou

nter

part

; in

form

atio

n on

pro

pose

d pr

oced

ures

and

saf

egua

rds

to p

reve

nt e

scap

e, d

isse

min

atio

n an

d co

ntam

inat

ion;

pro

pose

d m

etho

d of

fi na

l dis

posi

tion.

• W

hile

ther

e ar

e no

siz

e re

stric

tions

on fi e

ld tr

ials

, APH

IS o

ffi ci

als

take

into

con

side

ratio

n th

e si

ze o

f the

fi el

d tri

al w

hen

they

det

erm

ine

the

sign

ifi ca

nce

of th

e im

pact

on

the

envi

ronm

ent.

• A

PHIS

forw

ards

the

notifi

cat

ions

on

to re

leva

nt s

tate

age

ncie

s fo

r com

men

t with

in fi

ve d

ays

of re

ceip

t of t

he n

otifi

catio

n. S

tate

aut

horit

ies

can

com

men

t at t

heir

disc

retio

n, b

ut c

omm

ents

fro

m s

tate

aut

horit

ies

are

not r

equi

red

for t

he p

rogr

essi

on o

f the

ass

essm

ent p

roce

ss.

181

and the Gene Technology Agreement

Ass

essm

ent p

roce

ss fo

r in

tent

iona

l rel

ease

of a

GM

O

into

the

envi

ronm

ent (fi e

ld

tria

ls) (

cont

inue

d)

• I

n as

sess

ing

an a

pplic

atio

n fo

r a

perm

it, th

e A

PHIS

: m

ust b

e sa

tisfi e

d th

at th

e be

nefi t

s of

th

e pr

opos

al o

utw

eigh

the

cost

s; m

ay r

equi

re th

e pr

epar

atio

n of

an

envi

ronm

enta

l im

pact

st

atem

ent i

n ad

ditio

n to

an

envi

ronm

enta

l ass

essm

ent;

mus

t see

k pu

blic

com

men

t on

a pr

opos

al if

a p

erso

n ha

s su

bmitt

ed to

the

APH

IS a

pet

ition

to s

eek

a de

term

inat

ion

that

a

part

icul

ar G

MO

sho

uld

not b

e re

gula

ted

unde

r th

e le

gisl

atio

n; fi

eld

tria

l res

ults

mus

t be

subm

itted

to A

PHIS

with

in 6

mon

ths

of th

e te

rmin

atio

n of

a fi

eld

tria

l; .

APH

IS th

en m

akes

a

deci

sion

to a

ppro

ve th

e pe

titio

n in

who

le o

r in

par

t, or

to d

eny

the

petit

ion;

and

mus

t co

nsul

t Dep

artm

ents

of A

gric

ultu

re in

the

Stat

es w

here

rel

ease

is p

lann

ed.

• I

f the

GM

O is

als

o a

plan

t pes

ticid

e (p

lant

-inc

orpo

rate

d pr

otec

tant

; PIP

) the

n EP

A a

ppro

val

is a

lso

requ

ired

und

er th

e Fe

dera

l Ins

ectic

ide,

Fun

gici

de a

nd R

oden

ticid

e A

ct a

s pe

stic

ide

is

broa

dly

defi n

ed to

incl

ude

plan

ts m

odifi

ed b

y bi

otec

hnol

ogy

to r

esis

t dis

ease

. The

EPA

may

al

so tr

eat m

icro

-org

anis

ms

as s

ubje

ct to

the

Toxi

c Su

bsta

nces

Con

trol

Act

.

• A

‘det

erm

inat

ion

of n

on-r

egul

ated

’ sta

tus

is is

sued

by

APH

IS if

the

crop

is n

ot a

pla

nt p

est

allo

win

g th

e cr

op to

be

rele

ased

with

out r

estr

ictio

n. E

PA w

ould

als

o is

sue

appr

oval

.

• I

n th

e ca

se o

f PIP

s or

GM

mic

ro-o

rgan

ism

s fo

r pe

stic

ide

use,

the

EPA

doe

s an

eva

luat

ion

to a

sses

s th

e ri

sk:

to h

uman

hea

lth a

nd th

e en

viro

nmen

t; to

non

-tar

get o

rgan

ism

s; fo

r po

tent

ial g

ene fl o

w.

Con

side

ratio

n of

eth

ical

is

sues

• T

he o

nly

mat

ter

cons

ider

ed b

y A

PHIS

is w

heth

er th

e pl

ant i

s a

plan

t pes

t or

has

the

pote

ntia

l to

be a

pla

nt p

est.

Ethi

cs, t

rade

and

soc

ial i

ssue

s ar

e no

t tak

en in

to a

ccou

nt.

• H

owev

er, u

nder

the

Nat

iona

l Env

iron

men

tal P

olic

y A

ct th

e C

ounc

il on

Env

iron

men

tal

Qua

lity

take

s in

to a

ccou

nt th

e sc

ient

ifi c,

eco

nom

ic, s

ocia

l, ae

sthe

tic, a

nd c

ultu

ral n

eeds

an

d in

tere

sts

of th

e na

tion.

Appendix 8

182

Statutory Review of the Gene Technology Act 2000

Publ

ic c

onsu

ltatio

n on

ap

plic

atio

ns•

The

APH

IS o

nly

seek

s pu

blic

com

men

t on

a pr

opos

al if

a p

erso

n ha

s su

bmitt

ed to

the

APH

IS a

pet

ition

to s

eek

a de

term

inat

ion

that

a p

artic

ular

GM

O s

houl

d no

t be

regu

late

d un

der

the

legi

slat

ion.

APH

IS th

en m

akes

a d

ecis

ion

to a

ppro

ve th

e pe

titio

n in

who

le o

r in

pa

rt, o

r to

den

y th

e pe

titio

n. A

per

iod

of 6

0 da

ys is

giv

en fo

r pu

blic

con

sulta

tions

on

the

petit

ion.

• I

n co

nduc

ting

risk

ass

essm

ents

, the

dat

a us

ed b

y th

e EP

A u

nder

goes

ext

ensi

ve p

ublic

co

mm

ent a

nd p

eer

revi

ew b

y sc

ient

ifi c

expe

rts.

Prot

ectio

n of

con

fi den

tial

com

mer

cial

info

rmat

ion

• E

ach

of th

e re

leva

nt p

iece

s of

legi

slat

ion

prov

ide

for

the

prot

ectio

n of

con

fi den

tial

com

mer

cial

info

rmat

ion.

• P

ropo

nent

s ap

plyi

ng to

APH

IS fo

r a

perm

it m

ust p

rovi

de tw

o co

pies

of t

heir

app

licat

ion,

on

e w

ith c

onfi d

entia

l bus

ines

s in

form

atio

n pa

ssag

es m

arke

d an

d th

e ot

her

with

thes

e pa

ssag

es r

emov

ed.

Con

ditio

ns th

at m

ay b

e ap

plie

d•

APH

IS p

erm

its a

re s

ubje

ct to

sev

eral

con

ditio

ns p

resc

ribe

d in

the

regu

latio

ns, i

nclu

ding

: se

para

tion

of th

e G

MO

from

oth

er o

rgan

ism

s; tr

eatm

ent o

f mat

eria

l acc

ompa

nyin

g th

e G

MO

; com

plia

nce

with

mea

sure

s pr

escr

ibed

by

APH

IS w

hich

are

nec

essa

ry to

pre

vent

the

acci

dent

al o

r un

auth

oris

ed r

elea

se o

f the

GM

O; t

he r

equi

rem

ent t

hat t

he G

MO

be

subj

ect

to th

e ap

plic

atio

n of

rem

edia

l mea

sure

s de

term

ined

by

APH

IS to

be

nece

ssar

y to

pre

vent

th

e sp

read

of p

lant

pes

ts; t

he m

aint

enan

ce o

f the

GM

O o

nly

in th

e ar

eas

pres

crib

ed in

the

perm

it; a

nd in

spec

tors

mus

t be

allo

wed

acc

ess,

dur

ing

regu

lar

busi

ness

hou

rs, t

o pl

aces

w

here

the

GM

O is

loca

ted,

and

to r

ecor

ds r

elat

ing

to th

e in

trod

uctio

n of

the

GM

O.

• I

n ad

ditio

n, th

e pe

rmit

hold

er c

an b

e su

bjec

t to

any

othe

r co

nditi

ons

APH

IS d

eem

s as

ne

cess

ary

to p

reve

nt th

e di

ssem

inat

ion

and

esta

blis

hmen

t of p

lant

pes

ts.

Perm

it ca

n be

w

ithdr

awn

if no

n-co

mpl

ianc

e w

ith th

ese

cond

ition

s is

iden

tifi e

d.

• U

nusu

al o

ccur

renc

es (t

o th

ose

spec

ifi ed

in th

e ap

plic

atio

n, s

uch

as h

ighe

r ra

tes

of

mor

bidi

ty o

r m

orta

lity)

and

sus

pect

ed a

ccid

enta

l or

unau

thor

ised

rel

ease

of a

reg

ulat

ed

artic

le m

ust b

e no

tifi e

d to

APH

IS w

ithin

the

timef

ram

es s

pecifi e

d in

the

regu

latio

ns.

183

and the Gene Technology Agreement

Mon

itori

ng, s

urve

illan

ce a

nd

enfo

rcem

ent p

ower

s•

Onc

e pe

rmis

sion

for

the

culti

vatio

n of

a tr

ansg

enic

cro

p ha

s be

en g

rant

ed, p

rogr

ess

is

mon

itore

d. T

he s

yste

m d

oes

not r

ely

on s

ignifi c

ant e

nfor

cem

ent p

ower

s as

the

regu

lato

ry

syst

em is

bas

ed o

n ‘p

erm

its, t

estin

g an

d to

lera

nce

setti

ng’.

• A

ny r

egul

ated

art

icle

intr

oduc

ed n

ot in

com

plia

nce

with

the

requ

irem

ents

sha

ll be

sub

ject

to

the

imm

edia

te a

pplic

atio

n of

suc

h re

med

ial m

easu

res

or s

afeg

uard

s as

an

insp

ecto

r de

term

ines

nec

essa

ry to

pre

vent

the

intr

oduc

tion

of s

uch

plan

t pes

ts.

(Und

er th

e Fe

dera

l Pl

ant P

est A

ct, t

he S

ecre

tary

of A

gric

ultu

re is

aut

hori

sed

to o

rder

pro

mpt

rem

oval

from

the

Uni

ted

Stat

es o

r to

sei

ze, q

uara

ntin

e, tr

eat,

appl

y ot

her

rem

edia

l mea

sure

s to

, des

troy

, or

othe

rwis

e di

spos

e of

, in

such

man

ner

as th

e Se

cret

ary

deem

s ap

prop

riat

e, c

erta

in r

egul

ated

ar

ticle

s w

hich

are

bel

ieve

d to

be

infe

sted

or

infe

cted

by

or c

onta

in a

pla

nt p

est.)

• A

cces

s sh

all b

e al

low

ed fo

r APH

IS a

nd S

tate

reg

ulat

ory

offi c

ials

to in

spec

t fac

ilitie

s an

d/or

th

e fi e

ld te

st s

ite a

nd a

ny r

ecor

ds n

eces

sary

to e

valu

ate

com

plia

nce

with

the

prov

isio

ns.

• F

ield

test

rep

orts

mus

t be

subm

itted

with

in 1

2 m

onth

s of

the

star

t of a

fi el

d tr

ial a

nd th

en

ever

y 12

mon

ths

thro

ugh

the

dura

tion

of a

fi el

d tr

ial.

Pena

lties

• V

iola

tions

rel

atin

g to

pla

nt p

ests

can

incu

r cr

imin

al o

r ci

vil p

enal

ties.

• A

ny p

erso

n w

ho v

iola

tes

the

regu

latio

ns, o

r w

ho fo

rges

or

coun

terf

eits

any

per

mit

can

be

puni

shed

cri

min

ally

by

a fi n

e no

t exc

eedi

ng U

S$50

00 o

r by

impr

ison

men

t not

exc

eedi

ng

1 ye

ar, o

r bo

th.

Such

vio

latio

ns m

ay a

lso

be d

ealt

with

civ

illy

with

the

max

imum

fi ne

bei

ng

US$

1000

. H

owev

er, d

epen

ding

on

the

natu

re o

f the

vio

latio

n cr

imin

al p

enal

ties

can

rang

e up

to a

fi ne

of U

S$50

,000

or

a ye

ar in

jail

or b

oth.

• F

ailu

re to

adh

ere

to B

RS

regu

latio

ns, p

erm

it co

nditi

ons

and

requ

irem

ents

can

res

ult i

n se

riou

s pe

nalti

es, i

nclu

ding

fi ne

s up

to U

S$50

0,00

0 pe

r ad

judi

catio

n.

Appendix 8

184

Statutory Review of the Gene Technology Act 2000

Ass

essm

ent p

roce

ss fo

r

unre

stri

cted

inte

ntio

nal

rele

ase

of a

GM

O in

to th

e en

viro

nmen

t

• W

hen

an a

pplic

ant h

as fi

eld

test

ed a

tran

sgen

ic c

rop

and

accu

mul

ated

eno

ugh

data

to

show

that

this

cro

p is

free

from

any

ris

k (c

ompa

red

to it

s un

mod

ifi ed

cou

nter

part

), th

e ap

plic

ant c

an p

etiti

on A

PHIS

that

the

tran

sgen

ic c

rop

shou

ld n

o lo

nger

be

cons

ider

ed a

re

gula

ted

artic

le (a

nd th

us fr

ee fr

om a

ny m

onito

ring

or

rest

rict

ion)

. D

epen

ding

on

the

prod

uct a

nd it

s in

tend

ed p

urpo

se, r

evie

ws

by th

e FD

A (i

f int

ende

d fo

r fo

od u

se) a

nd th

e EP

A

may

als

o be

req

uire

d.

• T

he p

etiti

on is

req

uire

d to

incl

ude

data

suc

h as

: a

desc

ript

ion

of th

e bi

olog

y of

the

plan

t bef

ore

it w

as g

enet

ical

ly e

ngin

eere

d; e

xten

sive

dat

a fr

om te

sts

desi

gned

to d

etec

t di

ffere

nces

bet

wee

n th

e G

E pl

ant a

nd th

e or

igin

al p

lant

; cha

ract

eris

atio

n of

gen

etic

ch

ange

s; p

lant

pes

t-ri

sk c

hara

cter

istic

s; d

isea

se a

nd p

est s

usce

ptib

ilitie

s; e

xpre

ssio

n of

gen

e pr

oduc

ts; n

ew e

nzym

es; e

ffect

s on

non

-tar

get o

rgan

ism

s; c

hang

es in

pla

nt m

etab

olis

m;

wee

dine

ss o

f the

GE

plan

t; im

pact

on

the

wee

dine

ss o

f rel

ativ

es o

f the

GE

plan

t; im

pact

s on

agr

icul

tura

l pra

ctic

es o

r on

oth

er a

gric

ultu

ral p

rodu

cts;

fi el

d-te

st r

epor

ts fo

r al

l tri

als

cond

ucte

d un

der

perm

it or

not

ifi ca

tion

proc

edur

es in

volv

ing

the

GE

plan

t.

• C

ompl

eted

pet

ition

s ar

e pu

blis

hed

on th

e Fe

dera

l Reg

iste

r an

d pu

blic

com

men

t can

be

acce

pted

for

60 d

ays

from

the

date

of t

he p

ublic

atio

n on

the

Fede

ral R

egis

ter.

Ass

essm

ent p

roce

ss fo

r

unre

stri

cted

inte

ntio

nal

rele

ase

of a

GM

O in

to th

e en

viro

nmen

t (co

ntin

ued)

• T

he a

dmin

istr

ator

will

, with

in 1

80 d

ays

of r

ecei

ving

a c

ompl

eted

pet

ition

, eith

er:

appr

ove

the

petit

ion

in w

hole

or

in p

art;

or d

eny

the

petit

ion.

• A

PHIS

ann

ounc

es it

s de

cisi

on o

n th

e Fe

dera

l Reg

iste

r bu

t he

deci

sion

doe

s no

t bec

ome

fi nal

for

anot

her

30 d

ays

duri

ng w

hich

tim

e A

PHIS

may

alte

r its

dec

isio

n sh

ould

add

ition

al

info

rmat

ion

beco

me

avai

labl

e.

Con

side

ratio

n of

eth

ical

is

sues

• U

nder

the

Nat

iona

l Env

iron

men

tal P

olic

y A

ct th

e C

ounc

il on

Env

iron

men

tal Q

ualit

y sh

all

have

acc

ount

of s

cien

tifi c

, eco

nom

ic, s

ocia

l, ae

sthe

tic, a

nd c

ultu

ral n

eeds

and

inte

rest

s of

th

e na

tion.

185

and the Gene Technology Agreement

Publ

ic c

onsu

ltatio

n on

ap

plic

atio

ns•

Com

plet

ed p

etiti

ons

are

open

to p

ublic

com

men

t for

a p

erio

d of

60

days

.

Prot

ectio

n of

con

fi den

tial

com

mer

cial

info

rmat

ion

• E

ach

of th

e re

leva

nt p

iece

s of

legi

slat

ion

prov

ide

for

the

prot

ectio

n of

con

fi den

tial

com

mer

cial

info

rmat

ion.

• P

ropo

nent

s ap

plyi

ng to

APH

IS fo

r a

perm

it m

ust p

rovi

de tw

o co

pies

of t

heir

app

licat

ion,

on

e w

ith c

onfi d

entia

l bus

ines

s in

form

atio

n pa

ssag

es m

arke

d an

d th

e ot

her

with

thes

e pa

ssag

es r

emov

ed.

Con

ditio

ns th

at m

ay b

e ap

plie

d•

Afte

r a

petit

ion

for

dere

gula

tion

is g

rant

ed, t

here

are

no

rest

rict

ions

on

the

GM

O fo

r w

hich

th

e pe

titio

n w

as a

ppro

ved.

Mon

itori

ng, s

urve

illan

ce a

nd

enfo

rcem

ent p

ower

s•

Non

e

Pena

lties

• N

o pe

nalti

es a

pply

, as

once

a r

egul

ated

item

has

bee

n pe

titio

ned

and

beco

mes

a

dere

gula

ted

item

, it c

an b

e fr

eely

mov

ed a

nd p

lant

ed w

ithou

t BR

S re

gula

tory

con

trol

and

th

eref

ore

is n

o lo

nger

sub

ject

to th

e A

PHIS

or

BR

S re

gula

tions

.

Plac

ing

on t

he m

arke

t G

MO

s in

tend

ed fo

r fo

od o

r fe

ed

Ass

essm

ent p

roce

dure

for

plac

ing

on th

e m

arke

t GM

Os

inte

nded

for

food

or

feed

• A

pplic

ants

sho

uld

cons

ult w

ith th

e U

SFD

A b

efor

e su

bmitt

ing

a no

tifi c

atio

n fo

r pla

cing

food

s de

rived

from

nov

el p

lant

var

ietie

s (in

clud

ing

thos

e ge

netic

ally

eng

inee

red)

on

the

mar

ket.

• Th

e co

nsul

tatio

n is

a tw

o-st

ep p

roce

ss.

Initi

al c

onsu

ltatio

ns s

houl

d st

art e

arly

in th

e de

velo

pmen

t of t

he n

ovel

food

or f

eed

and

are

desi

gned

to re

solv

e po

tent

ial s

afet

y, n

utrit

iona

l, an

d re

gula

tory

issu

es.

Such

issu

es m

ay in

clud

e, b

ut a

re n

ot li

mite

d to

, sig

nifi c

antly

incr

ease

d le

vels

of p

lant

toxi

cant

s or

ant

i-nut

rient

s, re

duct

ion

of im

porta

nt n

utrie

nts,

new

alle

rgen

s, o

r th

e pr

esen

ce in

the

food

or f

eed

of a

n un

appr

oved

food

/feed

add

itive

.

Appendix 8

186

Statutory Review of the Gene Technology Act 2000

Ass

essm

ent p

roce

dure

for

plac

ing

on th

e m

arke

t GM

Os

inte

nded

for

food

or

feed

(c

ontin

ued)

• F

inal

con

sulta

tions

invo

lve

the

subm

issi

on to

the

USF

DA

of a

sum

mar

y of

the

safe

ty a

nd

nutri

tiona

l ass

essm

ent t

hat h

as b

een

cond

ucte

d an

d, if

nec

essa

ry, a

mee

ting

of th

e ap

plic

ant’s

sc

ient

ists

with

FD

A s

cien

tists

to d

iscu

ss th

e da

ta a

nd re

sults

con

tain

ed in

the

subm

issi

on.

• T

he s

afet

y an

d nu

tritio

nal a

sses

smen

t sho

uld

cont

ain

info

rmat

ion

on:

the

parti

cula

rs o

f the

G

E fo

od/fe

ed a

nd p

lant

der

ivat

ive;

the

inte

nded

use

of t

he p

rodu

ct (i

nclu

ding

if it

is in

tend

ed

for f

eed

use)

; the

par

ticul

ars

of th

e in

trodu

ced

gene

tic m

ater

ial;

the

purp

ose

or in

tend

ed

tech

nica

l effe

ct o

f the

mod

ifi ca

tion;

the

mod

ifi ca

tion’

s ex

pect

ed e

ffect

on

the

com

posi

tion

or

char

acte

ristic

pro

perti

es o

f the

food

or f

eed;

the

iden

tity

and

func

tion

of e

xpre

ssio

n pr

oduc

ts

enco

ded

by th

e in

trodu

ced

gene

tic m

ater

ial,

incl

udin

g an

est

imat

e of

the

conc

entra

tion

of

any

expr

essi

on p

rodu

ct in

the

bioe

ngin

eere

d cr

op o

r der

ived

food

/feed

; alle

rgen

icity

and

to

xici

ty; t

he b

asis

for c

oncl

udin

g th

at fo

ods

cont

aini

ng th

e ex

pres

sion

pro

duct

s ca

n be

saf

ely

cons

umed

; com

parin

g th

e co

mpo

sitio

n or

cha

ract

eris

tics

of th

e bi

oeng

inee

red

food

to th

at o

f fo

od d

eriv

ed fr

om th

e pa

rent

al v

arie

ty o

r oth

er c

omm

only

con

sum

ed v

arie

ties.

• D

urin

g th

e co

nsul

tatio

n pr

oces

s, th

e U

SFD

A d

oes

not c

ondu

ct a

com

preh

ensi

ve s

cien

tifi c

re

view

of d

ata

gene

rate

d by

the

deve

lope

r. In

stea

d, th

e U

SFD

A c

onsi

ders

, bas

ed o

n ag

ency

sc

ient

ists

’ eva

luat

ion

of th

e av

aila

ble

info

rmat

ion,

whe

ther

any

unr

esol

ved

issu

es e

xist

re

gard

ing

the

food

der

ived

from

the

new

pla

nt v

arie

ty th

at w

ould

nec

essi

tate

lega

l act

ion

by

the

agen

cy if

the

prod

uct w

ere

intr

oduc

ed in

to c

omm

erce

.

• D

urin

g th

e ea

rly

cons

ulta

tion

proc

ess,

an

appl

ican

t may

sub

mit

an e

arly

food

saf

ety

eval

uatio

n. T

he e

valu

atio

n is

inte

nded

to b

e do

ne p

rior

to th

e st

age

of d

evel

opm

ent w

here

th

e ne

w p

rote

ins

mig

ht in

adve

rten

tly e

nter

the

food

sup

ply.

The

info

rmat

ion

requ

irem

ents

ar

e si

mila

r to

the

abov

e sa

fety

and

nut

ritio

nal a

sses

smen

t. A

gui

danc

e do

cum

ent o

n th

e ev

alua

tion

proc

ess

stat

es th

at th

e ev

alua

tion

is to

be

ackn

owle

dged

with

in 1

5 da

ys o

f re

ceip

t by

the

USF

DA

and

a r

espo

nse

to th

e ap

plic

ant i

s gi

ven

with

in 1

20 d

ays

of r

ecei

pt

(whi

ch is

con

side

red

shor

t). A

res

pons

e m

ay:

exte

nd th

e re

view

tim

e fo

r an

othe

r 12

0 da

ys;

requ

est f

urth

er in

form

atio

n; c

oncl

ude

that

ther

e is

no

safe

ty r

isk

and

that

it s

atisfi e

s th

e re

quir

emen

ts o

f the

Fed

eral

Foo

d, D

rug

and

Cos

met

ic A

ct.

187

and the Gene Technology Agreement

Ass

essm

ent p

roce

dure

for

plac

ing

on th

e m

arke

t GM

Os

inte

nded

for

food

or

feed

(c

ontin

ued)

• O

nce

the

cons

ulta

tion

proc

ess

has

been

com

plet

ed, t

he a

pplic

ant s

houl

d th

en s

ubm

it a

pre-

mar

ket n

otifi

catio

n. T

his

notifi

cat

ion

shou

ld b

e su

bmitt

ed to

the

USF

DA

at l

east

120

da

ys b

efor

e th

e pl

anne

d co

mm

erci

alis

atio

n da

te.

The

USF

DA

has

dra

fted

a do

cum

ent o

n th

e pr

opos

ed ru

les

for p

re-m

arke

t not

ifi ca

tion.

In

this

doc

umen

t, it

is p

ropo

sed

that

pla

nts

mod

ifi ed

to c

onta

in a

pes

ticid

e su

bsta

nce

com

e un

der t

he U

SEPA

’s ju

risdi

ctio

n vi

a th

e Fe

dera

l Ins

ectic

ide,

Fun

gici

de a

nd R

oden

ticid

e A

ct.

Food

der

ived

form

pla

nts

who

se g

enet

ic

trans

form

atio

n ha

s al

read

y be

en a

sses

sed

by th

e U

SFD

A w

ill b

e ex

empt

from

the

prop

osed

re

gula

tion.

Pro

pose

d in

form

atio

n to

be

incl

uded

in th

e no

tifi c

atio

n in

clud

es:

the

parti

cula

rs

of th

e ge

netic

mod

ifi ca

tion;

the

iden

tity

and

func

tion

of th

ese

subs

tanc

es; t

he le

vel o

f the

se

subs

tanc

es in

the

bioe

ngin

eere

d fo

od; d

ieta

ry e

xpos

ure

to th

ese

subs

tanc

es; t

he p

oten

tial t

hat

the

food

will

be

an a

llerg

en; a

nd a

dis

cuss

ion

of o

ther

saf

ety

issu

es th

at m

ay b

e as

soci

ated

w

ith th

ese

subs

tanc

es.

Info

rmat

ion,

dat

a an

d re

sults

from

ear

lier e

valu

atio

ns (s

uch

as in

the

early

food

saf

ety

eval

uatio

n) m

ay b

e su

bmitt

ed a

s pa

rt of

the

notifi

cat

ion.

Con

side

ratio

n of

eth

ical

issu

es•

No

men

tion

of e

thic

al is

sues

was

foun

d in

the

rele

vant

gui

delin

es o

r le

gisl

atio

n.

Publ

ic c

onsu

ltatio

n on

ap

plic

atio

ns•

The

app

licat

ion

for

notifi

cat

ion

will

bec

ome

publ

ic w

hen

the

USF

DA

fi le

s it,

but

ther

e w

as

no s

pecifi c

men

tion

of p

ublic

con

sulta

tion

duri

ng th

e co

nsul

tativ

e or

not

ifi ca

tion

proc

ess.

Prot

ectio

n of

con

fi den

tial

com

mer

cial

info

rmat

ion

• T

he U

SFD

A tr

eats

sub

mitt

ed in

form

atio

n in

acc

orda

nce

with

the

Uni

ted

Stat

es F

reed

om o

f In

form

atio

n A

ct, w

hich

con

tain

s pr

ovis

ions

to e

xem

pt in

form

atio

n re

late

d to

‘tra

de s

ecre

t’ an

d co

mm

erci

al in

form

atio

n. T

he p

ropo

sed

guid

elin

es a

llow

the

appl

ican

t to

subm

it tw

o ve

rsio

ns o

f the

not

ifi ca

tion:

one

has

the

info

rmat

ion

dele

ted

that

the

appl

ican

t con

side

rs

exem

pt fr

om p

ublic

dis

clos

ure.

• T

he a

pplic

atio

n fo

r no

tifi c

atio

n w

ill b

ecom

e pu

blic

whe

n th

e U

SFD

A fi

les

it. H

owev

er,

ther

e is

pro

visi

on fo

r U

SFD

A to

eva

luat

e ap

plic

ant c

laim

s fo

r co

nfi d

entia

lity

acco

rdin

g to

th

e ex

empt

ion

crite

ria

unde

r th

e pr

opos

ed n

otifi

catio

n gu

idel

ines

.

Con

ditio

ns th

at m

ay b

e ap

plie

d•

Not

app

licab

le.

Onc

e th

e G

MO

inte

nded

for

food

/feed

use

is fo

und

to b

e sa

fe fo

r hu

man

an

d an

imal

con

sum

ptio

n, it

can

be

ente

red

into

the

mar

ket w

ithou

t res

tric

tion.

Appendix 8

188

Statutory Review of the Gene Technology Act 2000

Mon

itori

ng, s

urve

illan

ce a

nd

enfo

rcem

ent p

ower

s•

If a

bio

engi

neer

ed fo

od/fe

ed is

com

mer

cial

ised

with

out p

rior

app

rova

l, th

e U

SFD

A h

as

the

pow

er u

nder

the

Fede

ral F

ood,

Dru

g an

d C

osm

etic

Act

to c

ondu

ct in

spec

tions

and

in

vest

igat

ions

, col

lect

sam

ples

and

per

form

ana

lyse

s, a

s w

ell a

s to

eng

age

in p

ublic

ity a

nd

publ

ic e

duca

tion.

• T

he F

eder

al F

ood,

Dru

g an

d C

osm

etic

Act

sta

tes

that

all

food

add

itive

s re

ceiv

e U

SFD

A

appr

oval

bef

ore

com

mer

cial

isat

ion.

Foo

ds/fe

eds

deriv

ed fr

om o

r co

ntai

ning

gen

etic

ally

en

gine

ered

pla

nts

(or

prod

ucts

ther

eof)

wou

ld b

e co

nsid

ered

as

food

/feed

add

itive

s by

the

prop

osed

not

ifi ca

tion

guid

elin

es.

Pena

lties

• T

he F

eder

al F

ood,

Dru

g an

d C

osm

etic

Act

con

tain

s pr

ovis

ions

for

pena

lties

(cri

min

al a

nd

civi

l), in

clud

ing

seiz

ure

of th

e pr

oduc

t or

proc

eeds

ther

eof.

• P

enal

ties

exis

t for

con

trav

enin

g sp

ecifi

ed s

ectio

ns o

f the

Fed

eral

Foo

d, D

rug

and

Cos

met

ic

Act

. Th

ese

may

incl

ude:

im

pris

onm

ent f

or n

ot m

ore

than

one

yea

r or

fi ne

d no

t mor

e th

an $

1000

, or

both

; im

pris

onm

ent f

or n

ot m

ore

than

thre

e ye

ars

or fi

ned

not m

ore

than

$10

,000

or

both

if a

per

son

com

mits

ano

ther

vio

latio

n w

hile

a c

onvi

ctio

n of

him

is

pend

ing,

or

the

pers

on c

omm

its a

vio

latio

n w

ith th

e in

tent

to d

efra

ud o

r m

isle

ad; a

civ

il m

oney

pen

alty

of n

ot m

ore

than

$50

,000

for

an in

divi

dual

and

$25

0,00

0 fo

r an

y ot

her

pers

on, b

ut n

ot e

xcee

ding

$50

0,00

0 fo

r al

l vio

latio

ns in

a s

ingl

e pr

ocee

ding

for

any

pers

on

who

intr

oduc

es o

r de

liver

s, fo

r co

mm

erci

alis

atio

n, a

n ar

ticle

of f

ood/

feed

with

una

ppro

ved

food

/ fee

d ad

ditiv

es (t

his

wou

ld in

clud

e ad

ditiv

es d

eriv

ed fr

om o

r th

at a

re g

enet

ical

ly

engi

neer

ed p

lant

s).

Polic

y an

d G

over

nanc

e is

sues

Liab

ility

for

cont

amin

atio

n•

The

re is

no

stri

ct li

abili

ty r

egim

e fo

r re

cove

ry b

y th

ird

part

ies;

thir

d pa

rtie

s m

ust r

ely

on th

e co

mm

on la

w o

r re

med

ies

avai

labl

e un

der

gene

ral e

nvir

onm

ent p

rote

ctio

n le

gisl

atio

n.

189

and the Gene Technology Agreement

Expe

rt c

omm

ittee

s•

Inf

orm

atio

n ab

out c

omm

ittee

s is

cur

rent

ly b

eing

cla

rifi e

d bu

t the

re a

re n

o st

atut

ory

com

mitt

ees

that

exa

min

e G

MO

s sp

ecifi

cally

.

Res

earc

h•

The

Nat

iona

l Env

iron

men

tal P

olic

y A

ct s

tate

s th

at th

e Pr

esid

ent a

ppoi

nts

mem

bers

of t

he

Cou

ncil

on E

nvir

onm

enta

l Qua

lity

and

that

par

t of i

ts r

ole

is to

res

earc

h an

d co

llect

dat

a on

the

envi

ronm

ent a

nd e

cosy

stem

s an

d m

onito

r em

ergi

ng tr

ends

, and

to h

ave

acco

unt o

f sc

ient

ifi c,

eco

nom

ic, s

ocia

l, ae

sthe

tic, a

nd c

ultu

ral n

eeds

and

inte

rest

s of

the

natio

n.

• T

here

are

gov

ernm

ent a

genc

ies

that

are

abl

e to

res

earc

h va

riou

s as

pect

s of

GM

Os.

For

exam

ple:

• T

he A

gric

ultu

ral R

esea

rch

Serv

ice

(AR

S) is

USD

A’s

in h

ouse

sci

ence

age

ncy.

The

age

ncy’

s bi

otec

hnol

ogy

rese

arch

incl

udes

intr

oduc

ing

new

trai

ts a

nd im

prov

ing

exis

ting

trai

ts in

liv

esto

ck, c

rops

, and

mic

ro-o

rgan

ism

s; s

afeg

uard

ing

the

envi

ronm

ent;

and

asse

ssin

g an

d en

hanc

ing

the

safe

ty o

f bio

tech

nolo

gy p

rodu

cts.

• T

he C

oope

rativ

e St

ate

Res

earc

h, E

duca

tion,

and

Ext

ensi

on S

ervi

ce (C

SREE

S) a

dmin

iste

rs

the

Bio

tech

nolo

gy R

isk

Ass

essm

ent R

esea

rch

Gra

nts

Prog

ram

(BR

AG

) whi

ch s

uppo

rts

the

deve

lopm

ent o

f sci

ence

-bas

ed in

form

atio

n re

gard

ing

the

safe

ty o

f int

rodu

cing

into

the

envi

ronm

ent g

enet

ical

ly-m

odifi

ed p

lant

s, a

nim

als,

and

mic

ro-o

rgan

ism

s.

Oth

er

Liab

ility

for

cont

amin

atio

n•

No

refe

renc

e to

a s

tric

t lia

bilit

y re

gim

e or

no-

faul

t sch

eme

was

foun

d.

The

prec

autio

nary

pri

ncip

le•

The

legi

slat

ion

does

not

ref

eren

ce th

e pr

ecau

tiona

ry p

rinc

iple

.

Appendix 8

190

Statutory Review of the Gene Technology Act 2000

Cos

t rec

over

y•

The

re is

cap

acity

for

som

e co

st r

ecov

ery:

for

exam

ple,

per

mit

appl

icat

ions

car

ry a

cha

rge

but t

he s

ervi

ces

of in

spec

tors

dur

ing

regu

lar

assi

gned

hou

rs a

nd a

t usu

al p

lace

s of

dut

y ar

e fu

rnis

hed

with

out c

ost,

whe

reas

ove

rtim

e fo

r in

spec

tors

doe

s ca

rry

a co

st.

Mor

ator

ium

• N

o m

orat

oriu

m.

Oth

erTh

e pr

e-m

arke

t not

ifi ca

tion

guid

elin

es w

ere

mad

e in

200

1 an

d at

the

time

of c

ompi

ling

this

in

form

atio

n, it

did

not

app

ear

that

the

guid

elin

es h

ad b

een

enac

ted

into

legi

slat

ion.

191

and the Gene Technology Agreement

RE

GU

LA

TIO

N O

F G

EN

E T

EC

HN

OL

OG

Y I

N C

AN

AD

A

SUM

MA

RY —

Can

ada

does

not

hav

e a

sing

le p

iece

of l

egis

latio

n th

at r

egul

ates

GM

Os.

Mos

t of t

he le

gisl

atio

n ap

plic

able

to

bio

tech

nolo

gy a

ddre

sses

spe

cifi c

pro

duct

cat

egor

ies,

and

per

tain

s bo

th to

bio

logi

cal a

nd n

on-b

iolo

gica

l pro

cess

es a

nd

prod

ucts

.

• T

he m

ain

agen

cies

invo

lved

in th

e re

gula

tion

of G

MO

s ar

e A

gric

ultu

re a

nd A

gri-

Food

Can

ada,

Env

iron

men

t Can

ada

and

Hea

lth a

nd W

elfa

re C

anad

a. T

he r

elev

ant l

egis

latio

n in

clud

es:

Can

adia

n En

viro

nmen

t Pro

tect

ion

Act

199

9 (C

EPA

) (c

over

s th

ose

uses

not

cov

ered

by

othe

r le

gisl

atio

n); F

eeds

Act

(fee

ds);

Fert

ilise

rs A

ct (s

uppl

emen

ts);

Hea

lth o

f Ani

mal

s A

ct (v

eter

inar

y bi

olog

ics)

; See

ds A

ct (p

lant

s w

ith n

ovel

trai

ts);

Pest

Con

trol

Pro

duct

s A

ct (m

icro

bial

pes

t con

trol

age

nts)

; an

d Fo

od a

nd D

rugs

Act

(dru

gs, c

osm

etic

s, m

edic

al d

evic

es, a

nd n

ovel

food

s fr

om b

oth

plan

t and

ani

mal

sou

rces

); Pl

ant

Prot

ectio

n A

ct (i

mpo

rtat

ion

of u

napp

rove

d pl

ants

with

nov

el tr

aits

).

• T

he r

elea

se o

f nov

el s

ubst

ance

s (th

is in

clud

es G

MO

s) in

to th

e en

viro

nmen

t is

gove

rned

by

the

abov

e-m

entio

ned

Act

s.

Ther

e ar

e al

so d

irec

tives

that

pro

vide

gui

delin

es fo

r ap

plyi

ng fo

r th

e re

leas

e of

nov

el s

ubst

ance

s in

to th

e en

viro

nmen

t. In

ad

ditio

n, th

ere

are

dire

ctiv

es fo

r th

e re

leas

e of

nov

el p

lant

and

ani

mal

org

anis

ms

for

both

con

fi ned

and

unc

onfi n

ed r

elea

ses.

Th

e C

anad

ian

Food

Insp

ectio

n A

genc

y, u

nder

the

Agr

icul

ture

and

Agr

i-Fo

od P

ortfo

lio, i

s th

e m

ain

agen

cy r

espo

nsib

le fo

r th

e re

leas

e of

nov

el s

ubst

ance

into

the

envi

ronm

ent a

nd is

div

ided

into

Sec

tions

. O

ne o

f the

sec

tions

, the

Pla

nt B

iosa

fety

O

ffi ce

has

car

riag

e of

ass

essi

ng a

pplic

atio

ns fo

r th

e co

nfi n

ed a

nd u

ncon

fi ned

rel

ease

of n

ovel

sub

stan

ces

(pla

nt) i

nto

the

envi

ronm

ent.

If th

e no

vel p

lant

s co

uld

be u

sed

as a

feed

(for

live

stoc

k or

labo

rato

ry a

nim

als)

, the

n th

e Fe

ed S

ectio

n of

the

Can

adia

n Fo

od In

spec

tion

Age

ncy

asse

sses

the

appl

icat

ion

for

rele

ase.

App

licat

ions

for

rele

ase

of n

ovel

sub

stan

ces

that

co

uld

be u

sed

as fo

od fo

r hu

man

s ar

e as

sess

ed b

y th

e D

epar

tmen

t of H

ealth

. W

here

nec

essa

ry, a

ppro

val f

or r

elea

se o

f a

nove

l sub

stan

ce m

ay r

equi

re a

ppro

val f

rom

mor

e th

an o

ne a

utho

rity

/age

ncy.

192

Statutory Review of the Gene Technology Act 2000

Con

tain

ed w

ork

wit

h G

MO

s

Res

pons

ible

age

ncy

• C

anad

ian

Med

ical

Res

earc

h C

ounc

il.

• G

uide

lines

of t

he U

nite

d St

ates

of A

mer

ica’

s N

atio

nal I

nstit

ute

of H

ealth

(NIH

).

Legi

slat

ion

• C

onta

ined

res

earc

h in

volv

ing

GM

Os

is n

ot c

over

ed b

y C

EPA

.

• L

abor

ator

y re

sear

ch in

Can

ada

is c

over

ed b

y th

e U

S N

IH’s

Gui

delin

es fo

r R

esea

rch

Invo

lvin

g R

ecom

bina

nt D

NA

Mol

ecul

es.

All

scie

ntis

ts w

orki

ng w

ith G

MO

s m

ust a

dher

e to

the

guid

elin

es

esta

blis

hed

by th

e M

edic

al R

esea

rch

Cou

ncil,

as

wel

l as

code

s of

pra

ctic

e es

tabl

ishe

d by

thei

r ow

n in

stitu

tion.

Inte

ntio

nal r

elea

ses

of G

MO

s in

the

env

iron

men

t

Res

pons

ible

age

ncy

• E

nvir

onm

ent C

anad

a.

Legi

slat

ion

• C

EPA

.

• D

irec

tive

2000

–07:

Con

duct

ing

Con

fi ned

Res

earc

h Fi

eld

Tria

ls o

f Pla

nts

with

Nov

el T

raits

in

Can

ada.

• S

eeds

Act

and

am

endm

ents

.

• D

irec

tive

95–0

3: G

uide

lines

for

the

Ass

essm

ent o

f Nov

el F

eeds

: Pl

ant S

ourc

es.

• F

eeds

Act

and

am

endm

ents

.

• D

irec

tive

94–0

8: A

sses

smen

t Cri

teri

a fo

r D

eter

min

ing

Envi

ronm

enta

l Saf

ety

of P

lant

s W

ith N

ovel

Tr

aits

.

Cov

erag

e of

the

legi

slat

ion

• S

ubst

ance

s th

at a

re n

ew (i

.e. n

ot o

n th

e lis

t of D

omes

tic S

ubst

ance

s) c

anno

t be

man

ufac

ture

d or

im

port

ed u

nles

s ap

prov

al is

gra

nted

from

the

Min

iste

r.

193

and the Gene Technology Agreement

Cov

erag

e of

th

e le

gisl

atio

n (c

ontin

ued)

• S

ubst

ance

is d

efi n

ed a

s an

y di

stin

guis

habl

e ki

nd o

f org

anic

or

inor

gani

c m

atte

r, w

heth

er a

nim

ate

or

inan

imat

e, a

nd in

clud

es a

ny m

atte

r th

at is

cap

able

of b

eing

dis

pers

ed in

the

envi

ronm

ent o

r of

bei

ng

tran

sfor

med

in th

e en

viro

nmen

t int

o m

atte

r th

at is

cap

able

of b

eing

so

disp

erse

d or

that

is c

apab

le o

f ca

usin

g su

ch tr

ansf

orm

atio

n in

the

envi

ronm

ent.

‘Liv

ing

orga

nism

’ is

defi n

ed a

s a

subs

tanc

e th

at is

an

ani

mat

e pr

oduc

t of b

iote

chno

logy

.

• Th

e C

anad

ian

Food

Insp

ectio

n A

genc

y’s

Plan

t Bio

safe

ty O

ffi ce

is re

spon

sibl

e fo

r reg

ulat

ing

the

inte

ntio

nal

intro

duct

ion

into

the

envi

ronm

ent i

n C

anad

a of

pla

nts

with

nov

el tr

aits

(PN

Ts).

The

pro

cedu

res

and

guid

elin

es fo

r app

lyin

g to

rele

ase

PNTs

into

the

envi

ronm

ent a

re o

utlin

ed in

Dire

ctiv

e 20

00–0

7.

• T

he F

eeds

Act

gov

erns

the

use

of fe

ed w

ithin

Can

ada

and

ensu

res

that

it is

saf

e to

use

. N

ovel

feed

s,

incl

udin

g th

ose

with

a n

ovel

trai

t req

uire

a n

otifi

catio

n of

inte

nded

rele

ase

to b

e ap

prov

ed b

y th

e re

leva

nt m

inis

ter b

efor

e th

ey c

an b

e re

leas

ed.

The

Act

and

its

Reg

ulat

ions

refe

r to

the

rele

ase

of n

ovel

fe

eds,

incl

udin

g th

ose

with

nov

el tr

aits

, for

rese

arch

pur

pose

s on

ly.

• D

irec

tive

95-0

3 ap

plie

s to

nov

el fe

eds

from

pla

nts,

or

part

s or

pro

duct

s th

ereo

f, th

at h

ave

not b

een

prev

ious

ly u

sed

as li

vest

ock

feed

in C

anad

a, a

nd/o

r ha

ve a

nov

el tr

ait.

The

app

licat

ion

requ

ires

in

form

atio

n on

the

nove

l tra

it, te

chni

ques

use

d, th

e br

eedi

ng h

isto

ry, n

utri

tiona

l dat

a, to

xico

logy

dat

a an

d di

etar

y ex

posu

re, a

llerg

y da

ta, a

nim

al/li

vest

ock

tria

l dat

a, a

n en

viro

nmen

tal r

isk

asse

ssm

ent,

dete

ctio

n m

etho

ds.

The

guid

elin

es a

ppea

r as

thou

gh th

ey c

an b

e us

ed fo

r ap

plyi

ng fo

r re

leas

e of

no

vel f

eed

(pla

nt s

ourc

e) fo

r ev

entu

al c

omm

erci

alis

atio

n.

Ass

essm

ent p

roce

ss

for

confi

ned

in

tent

iona

l rel

ease

s of

a G

MO

into

the

envi

ronm

ent (fi e

ld

tria

ls),

incl

udin

g fo

r ex

peri

men

ts o

n G

MO

s in

tend

ed fo

r fe

ed

• T

he M

inis

ter

mus

t be

notifi

ed

if so

meo

ne w

ishe

s to

man

ufac

ture

or

impo

rt a

new

sub

stan

ce th

at is

no

t on

the

Dom

estic

Sub

stan

ces

List

(if i

t is

on th

e lis

t no

appr

oval

is n

eces

sary

).

• I

nfor

mat

ion

rele

vant

to th

e as

sess

men

t mus

t be

prov

ided

to th

e M

inis

ter.

• A

ll pr

opos

als

unde

rgo

a si

ngle

60-

day

publ

ic c

onsu

ltatio

n pe

riod

whe

re in

tere

sted

par

ties

may

bri

ng

forw

ard

addi

tiona

l sci

entifi

c e

vide

nce

to s

uppo

rt o

r re

fute

the

Min

iste

r’s d

ecis

ion.

• A

fter

taki

ng in

to a

ccou

nt a

ny a

dvic

e pr

ovid

ed, t

he M

inis

ter

mus

t dec

ide

whe

ther

the

subs

tanc

e is

to

xic

or c

apab

le o

f bec

omin

g to

xic.

Appendix 8

194

Statutory Review of the Gene Technology Act 2000

Ass

essm

ent p

roce

ss

for

confi

ned

in

tent

iona

l rel

ease

s of

a G

MO

into

the

envi

ronm

ent (fi e

ld

tria

ls),

incl

udin

g fo

r ex

peri

men

ts o

n G

MO

s in

tend

ed fo

r fe

ed (c

ontin

ued)

• I

f the

Min

iste

r dec

ides

that

the

orga

nism

is n

ot to

xic

or c

apab

le o

f bec

omin

g to

xic,

the

Min

iste

r can

pl

ace

the

orga

nism

on

the

Dom

estic

Sub

stan

ce R

egis

ter b

ut c

anno

t im

pose

any

con

ditio

ns.

• I

f the

Min

iste

r de

cide

s th

at th

e or

gani

sm is

toxi

c or

cap

able

of b

ecom

ing

toxi

c, th

en th

e M

inis

ter

can:

(a) p

erm

it its

man

ufac

ture

or

impo

rtat

ion

subj

ect t

o an

y co

nditi

ons

the

Min

iste

r m

ay s

peci

fy; o

r (b

) can

pro

hibi

t its

impo

rt o

r m

anuf

actu

re.

• T

he fi

nal d

ecis

ion

of th

e M

inis

ter

mus

t be

publ

ishe

d.

• U

nder

Dir

ectiv

e 20

00–0

7 (w

hich

pro

vide

s gu

idel

ines

to th

e ap

plic

ant o

n ho

w to

app

ly fo

r th

e co

nfi n

ed r

elea

se o

f a P

NT)

the

appl

icat

ion

for

a co

nfi n

ed r

esea

rch fi e

ld tr

ial:

put

s th

e on

us o

n th

e ap

plic

ant t

o en

sure

that

the

PNT

will

not

neg

ativ

ely

affe

ct a

ny o

ther

tria

l or

non-

PNT

crop

s;

requ

ires

the

appl

ican

t to

cons

ider

con

tinge

ncy

plan

s in

the

even

t of a

ccid

enta

l rel

ease

of m

ater

ial

or in

adve

rten

t bre

akdo

wn

of r

epro

duct

ive

isol

atio

n. I

f the

app

lican

t int

ends

on

feed

ing

the

mat

eria

l fr

om th

e co

nfi n

ed r

esea

rch fi e

ld tr

ial t

o liv

esto

ck fo

r re

sear

ch p

urpo

ses,

the

appl

icat

ion

is g

iven

to

the

Feed

Sec

tion

of th

e C

anad

ian

Food

Insp

ectio

n A

genc

y. T

he a

pplic

atio

ns a

re s

ent t

o pr

ovin

cial

go

vern

men

ts w

here

the

tria

ls w

ill o

ccur

, who

then

hav

e 30

day

s to

pro

vide

com

men

t. T

he

com

men

ts a

re c

onsi

dere

d by

the

Plan

t Bio

safe

ty O

ffi ce

whe

n m

akin

g a

deci

sion

on

the

appl

icat

ion.

To

ens

ure

that

the

tria

ls a

re fo

r re

sear

ch p

urpo

ses

only

: ea

ch tr

ial s

ite m

ust b

e no

larg

er th

an 1

Ha;

th

ere

are

no m

ore

than

10

tria

l site

s pe

r su

bmis

sion

, per

pro

vinc

e; tr

ial s

ite lo

catio

ns a

re n

o la

rger

th

an 5

Ha

cum

ulat

ive

per

subm

issi

on, p

er p

rovi

nce.

The

app

lican

t is

resp

onsi

ble

for

repr

oduc

tive

isol

atio

n or

oth

er is

olat

ion

met

hods

(suc

h as

bag

s an

d ne

ts o

ver fl o

wer

ing

plan

t par

ts, h

arve

st o

f pl

ant b

efor

e fl o

wer

ing,

rem

oval

of fl

ow

ers

befo

re p

olle

n m

atur

ity).

195

and the Gene Technology Agreement

Ass

essm

ent p

roce

ss

for

confi

ned

in

tent

iona

l rel

ease

s of

a G

MO

into

the

envi

ronm

ent (fi e

ld

tria

ls),

incl

udin

g fo

r ex

peri

men

ts o

n G

MO

s in

tend

ed fo

r fe

ed (c

ontin

ued)

• U

nder

the

Feed

s A

ct a

nd it

s am

endm

ents

and

reg

ulat

ions

a w

ritte

n no

tifi c

atio

n of

the

prop

osed

re

leas

e m

ust b

e m

ade

to th

e M

inis

ter,

incl

udin

g in

form

atio

n su

ch a

s: t

he p

artic

ular

s of

the

rele

ase;

co

nfi n

emen

t and

mon

itori

ng p

roce

dure

s; m

etho

ds fo

r sa

fe d

ispo

sal;

cont

inge

ncy

plan

s to

miti

gate

ad

vers

e ef

fect

s on

hum

ans

and

the

envi

ronm

ent i

n th

e ev

ent o

f acc

iden

tal r

elea

se; t

he p

artic

ular

s of

th

e no

vel t

rait;

any

res

ults

from

dat

a or

res

earc

h do

ne to

iden

tify

risk

s to

the

envi

ronm

ent o

r hu

man

he

alth

. Th

e M

inis

ter

for A

gric

ultu

re a

nd A

gri-

food

s ca

n th

en e

ither

aut

hori

se o

r re

fuse

to a

utho

rise

th

e re

leas

e of

the

nove

l fee

d an

d sh

all c

onsi

der

the

mag

nitu

de o

f exp

osur

e of

the

rele

ase,

the

effe

cts

on th

e en

viro

nmen

t and

whe

ther

the

nove

l fee

d is

toxi

c. T

he a

pplic

atio

n sh

all b

e ac

com

pani

ed w

ith

evid

ence

(suc

h as

sci

entifi

c r

esea

rch)

to p

erm

it an

ass

essm

ent o

r ev

alua

tion

of th

e sa

fety

and

effi

cacy

of

the

feed

in r

espe

ct o

f liv

esto

ck a

nd it

s po

tent

ial e

ffect

on

hum

ans

and

on th

e en

viro

nmen

t.

• D

irect

ive

95-0

3 pr

ovid

es th

e gu

idel

ines

for t

he c

ompl

etio

n of

an

appl

icat

ion

for t

he u

ncon

fi ned

rel

ease

of

a n

ovel

feed

from

pla

nt s

ourc

es. A

pplic

atio

ns s

houl

d co

ntai

n: s

uffi c

ient

dat

a ab

out t

he n

ovel

trai

t; in

form

atio

n ab

out t

he m

odifi

catio

n hi

stor

y; c

hara

cter

isat

ion

of th

e D

NA

inse

rted,

if a

ny; n

utrit

iona

l da

ta, a

llerg

enic

ity d

ata;

toxi

colo

gy d

ata;

die

tary

exp

osur

e; la

bora

tory

ani

mal

/live

stoc

k fe

edin

g tri

al

data

; env

ironm

enta

l ris

k as

sess

men

t; m

etho

d of

det

ectio

n. A

dec

isio

n is

then

mad

e on

the

info

rmat

ion

prov

ided

in th

e ap

plic

atio

n.

• Th

e ap

plic

atio

n pr

oced

ure

and

info

rmat

ion

requ

irem

ents

for r

elea

sing

of a

nov

el fe

ed o

f an

anim

al o

rigin

is

sim

ilar t

o th

at fo

r a n

ovel

feed

from

a p

lant

sou

rce

and

is o

utlin

ed in

the

Feed

s Act

and

regu

latio

ns.

• T

here

is a

dra

ft do

cum

ent t

hat o

utlin

es th

e ap

plic

atio

n re

quire

men

ts fo

r not

ifi ca

tion

of a

rele

ase

of

biot

echn

olog

y-de

rived

live

stoc

k an

imal

s. T

his

draf

t app

ears

to a

pply

to c

onfi n

ed a

nd u

ncon

fi ned

re

leas

es.

Info

rmat

ion

requ

irem

ents

incl

ude

info

rmat

ion:

on

the

orga

nism

; on

the

orga

nism

’s m

anuf

actu

re o

r im

port;

on

the

intro

duct

ion

of th

e or

gani

sm; o

n th

e en

viro

nmen

tal f

ate

of th

e or

gani

sm;

on th

e or

gani

sm’s

envi

ronm

enta

l effe

cts;

on

pote

ntia

l adv

erse

effe

cts

on h

uman

hea

lth; o

n te

st d

ata

that

as

sist

s in

the

iden

tifi c

atio

n of

haz

ards

to h

uman

hea

lth a

nd e

nviro

nmen

t. If

the

orga

nism

is c

onfi n

ed,

info

rmat

ion

on th

e po

ssib

le m

echa

nism

s fo

r esc

ape

and

poss

ible

dis

pers

al is

als

o re

quire

d.

Appendix 8

196

Statutory Review of the Gene Technology Act 2000

Con

side

ratio

n of

et

hica

l iss

ues

• I

n m

akin

g a

deci

sion

Min

iste

rs m

ay o

nly

dete

rmin

e w

heth

er th

e su

bsta

nce

is to

xic

or c

apab

le

of b

ecom

ing

toxi

c. N

o sp

ecifi

c m

entio

n of

eth

ics

or tr

ade

is m

ade.

How

ever

, the

Min

iste

r m

ay

take

into

acc

ount

fact

ors

such

as,

but

not

lim

ited

to s

ocia

l, ec

onom

ic a

nd te

chni

cal m

atte

rs

whe

n de

term

inin

g pr

even

tativ

e or

con

trol

act

ion

in r

elat

ion

to a

sub

stan

ce o

r in

pla

ns fo

r vi

rtua

l el

imin

atio

n of

the

subs

tanc

e.

Publ

ic c

onsu

ltatio

n on

app

licat

ions

• A

ll pr

opos

als

for

rele

ase

of a

GM

O in

to th

e en

viro

nmen

t und

ergo

a s

ingl

e 60

-day

pub

lic

cons

ulta

tion

peri

od w

here

inte

rest

ed p

artie

s m

ay b

ring

forw

ard

addi

tiona

l sci

entifi

c e

vide

nce

to

supp

ort o

r re

fute

the

Min

iste

r’s d

ecis

ion.

Prot

ectio

n of

co

nfi d

entia

l co

mm

erci

al

info

rmat

ion

• A

n ap

plic

ant m

ay r

eque

st th

at in

form

atio

n be

trea

ted

as c

onfi d

entia

l.

• T

he M

inis

ter

mus

t not

dis

clos

e an

y in

form

atio

n in

res

pect

of w

hich

a r

eque

st fo

r co

nfi d

entia

lity

has

been

mad

e un

less

: it

is in

the

publ

ic in

tere

st; o

r it

is d

iscl

osed

und

er a

n ag

reem

ent b

etw

een

the

Gov

ernm

ent o

f Can

ada

and

any

othe

r go

vern

men

t of C

anad

a or

gov

ernm

ent o

f a fo

reig

n st

ate

etc,

an

d th

e ag

ency

agr

ees

to k

eep

the

info

rmat

ion

confi

den

tial.

Con

ditio

ns th

at m

ay

be a

pplie

d•

Whe

re th

e M

inis

ter

susp

ects

that

a li

ving

org

anis

m is

toxi

c or

cap

able

of b

eing

toxi

c, th

e M

inis

ter

for

the

Envi

ronm

ent m

ay p

erm

it th

e m

anuf

actu

re o

r im

port

of t

he li

ving

org

anis

ms

subj

ect t

o an

y co

nditi

ons

that

the

Min

iste

r m

ay s

peci

fy.

Mon

itori

ng,

surv

eilla

nce

and

enfo

rcem

ent p

ower

s

• E

nfor

cem

ent o

ffi ce

rs m

ay b

e ap

poin

ted

unde

r th

e C

EPA

.

• E

nfor

cem

ent o

ffi ce

rs h

ave

the

pow

er to

ent

er a

nd in

spec

t pre

mis

es w

here

a s

ubst

ance

can

be

foun

d,

for

the

purp

oses

of t

he A

ct. O

ffi ce

rs h

ave

been

giv

en w

ide

pow

ers

of in

spec

tion,

incl

udin

g op

enin

g re

cept

acle

s an

d pa

ckag

es, e

xam

inin

g re

cord

s, ta

king

sam

ples

and

con

duct

ing

test

s. C

EPA

als

o al

low

s offi c

ers

to a

ct w

ithou

t war

rant

s in

em

erge

ncie

s. O

ffi ce

rs m

ay s

eize

or

deta

in a

nyth

ing

whi

ch

caus

ed a

con

trav

entio

n to

occ

ur, o

r w

hich

will

pro

vide

evi

denc

e of

the

cont

rave

ntio

n; h

owev

er, t

hey

can

only

do

so if

it is

req

uire

d fo

r ev

iden

ce, a

naly

sis

or it

is in

the

publ

ic in

tere

st to

do

so.

197

and the Gene Technology Agreement

Mon

itori

ng,

surv

eilla

nce

and

enfo

rcem

ent p

ower

s (c

ontin

ued)

• O

ffi ce

rs m

ay a

lso

issu

e en

viro

nmen

tal p

rote

ctio

n co

mpl

ianc

e or

ders

to o

wne

rs a

nd m

anag

ers

and

pers

ons

cont

ribu

ting

to c

ontr

aven

tions

whi

ch m

ust b

e co

mpl

ied

with

(ord

ers

can

incl

ude

repo

rtin

g re

quir

emen

ts, a

nd to

cea

se o

pera

ting)

.

• U

nder

Dir

ectiv

e 20

00-0

7, th

e C

anad

ian

Food

Insp

ectio

n A

genc

y re

quir

es th

e ap

plic

ant t

o ke

ep

reco

rds

rega

rdin

g th

e m

anag

emen

t of t

he s

ite (i

nclu

ding

mon

itori

ng, h

arve

stin

g, c

lean

ing

of

harv

estin

g m

achi

nery

, tra

nspo

rtat

ion

and

stor

age

of th

e pl

ant m

ater

ial)

and

the

reco

rds

mus

t be

mad

e av

aila

ble

upon

req

uest

. Reg

iona

l Foo

d In

spec

tion

offi c

ers

have

the

pow

er to

insp

ect t

rial

site

s du

ring

th

e gr

owin

g se

ason

at r

ando

m a

nd w

ithou

t not

ifi ca

tion.

• U

nder

the

Feed

s A

ct a

nd S

eeds

Act

, the

re a

re p

rovi

sion

s fo

r in

spec

tions

and

insp

ecto

rs to

sei

ze a

nd

deta

in a

rtic

les,

ope

n pa

ckag

es a

nd ta

ke s

ampl

es, w

here

an

insp

ecto

r be

lieve

s on

rea

sona

ble

grou

nds

that

the

Act

or

the

regu

latio

ns h

ave

been

con

trav

ened

.

Pena

lties

• A

max

imum

fi ne

of C

A$1

,000

,000

or

a pr

ison

term

of 3

yea

rs e

xist

s (if

con

vict

ed o

n in

dict

men

t) fo

r pe

rson

s w

ho c

ontr

aven

e a

prov

isio

n of

the

Act

or

regu

latio

ns, a

n or

der

or d

irec

tion

unde

r th

e A

ct o

r an

obl

igat

ion

or a

pro

hibi

tion

aris

ing

from

the

Act

or

regu

latio

ns, o

r w

ho k

now

ingl

y pr

ovid

e fa

lse

or

mis

lead

ing

info

rmat

ion.

• F

or s

umm

ary

conv

ictio

n it

is C

A$3

00,0

00 o

r 6

mon

ths.

• I

f, in

com

mitt

ing

the

offe

nce,

a p

erso

n in

tent

iona

lly o

r re

ckle

ssly

cau

ses

a di

sast

er th

at r

esul

ts in

loss

of

the

use

of th

e en

viro

nmen

t, or

sho

ws

wan

ton

disr

egar

d fo

r th

e liv

es o

r sa

fety

of o

ther

per

sons

and

th

ereb

y ca

uses

a r

isk

of d

eath

or

harm

to a

noth

er p

erso

n, th

e m

axim

um p

riso

n te

rm in

crea

ses

to 5

ye

ars

and

ther

e ca

n be

an

unlim

ited fi n

e im

pose

d.

• E

ach

day

the

offe

nce

is c

omm

itted

is a

sep

arat

e of

fenc

e. T

he C

EPA

als

o se

ts d

own

crite

ria

whi

ch

the

Cou

rt m

ust l

ook

at w

hen

sent

enci

ng, i

nclu

ding

har

m c

ause

d, th

e co

sts

of a

ny r

emed

ial a

ctio

ns,

inte

ntio

n, a

nd a

ny p

rope

rty,

ben

efi t

or a

dvan

tage

to th

e of

fend

er.

Appendix 8

198

Statutory Review of the Gene Technology Act 2000

Pena

lties

(con

tinue

d)•

Des

pite

the

max

imum

am

ount

of a

ny fi

ne u

nder

the

legi

slat

ion,

a c

ourt

may

impo

se a

n ad

ditio

nal

fi ne

equa

l to

the

cour

t’s e

stim

atio

n of

the

amou

nt o

f pro

pert

y, b

enefi

t or

adv

anta

ge d

eriv

ed b

y th

e of

fend

er fr

om th

eir

actio

ns. I

nste

ad o

f con

vict

ing

an o

ffend

er, o

r in

add

ition

to o

ther

pun

ishm

ents

, a

cour

t may

mak

e an

ord

er r

equi

ring

the

offe

nder

to d

o or

ref

rain

from

doi

ng c

erta

in a

ctio

n (e

.g.

requ

irin

g th

e of

fend

er to

take

any

act

ion

to r

emed

y or

avo

id h

arm

, pre

pare

and

impl

emen

t a

pollu

tion

prev

entio

n pl

an, c

arry

out

env

iron

men

tal e

ffect

s m

onito

ring

, com

pens

ate

the

Min

iste

r, pa

y an

am

ount

to e

nvir

onm

enta

l, he

alth

or

othe

r gr

oups

or

to s

chol

arsh

ips

for

stud

ents

enr

olle

d in

en

viro

nmen

tal s

tudi

es, o

r pu

blis

h th

e fa

cts

rela

ting

to th

e in

cide

nt).

• P

enal

ties

for

cont

rave

ning

the

Feed

s A

ct o

r th

e Se

eds

Act

incl

ude:

a fi

ne o

f up

to C

A$5

0,00

0 or

six

m

onth

s im

pris

onm

ent o

r bo

th fo

r an

offe

nce

puni

shab

le b

y su

mm

ary

conv

ictio

n; a

fi ne

of u

p to

C

A$2

50,0

00 o

r tw

o ye

ars

impr

ison

men

t or

both

.

Plac

ing

GM

Os

(or

prod

ucts

con

tain

ing

GM

Os)

on

the

mar

ket

Res

pons

ible

age

ncy

• E

nvir

onm

ent C

anad

a.

• T

he C

anad

ian

Food

Insp

ectio

n A

genc

y’s

Plan

t Bio

safe

ty O

ffi ce

is r

espo

nsib

le fo

r re

gula

ting

the

inte

ntio

nal i

ntro

duct

ion

into

the

envi

ronm

ent i

n C

anad

a of

pla

nts

with

nov

el tr

aits

(PN

Ts).

Legi

slat

ion

• F

eeds

Act

and

am

endm

ents

.

• D

irec

tive

94-0

8: A

sses

smen

t Cri

teri

a fo

r D

eter

min

ing

Envi

ronm

enta

l Saf

ety

of P

lant

s W

ith N

ovel

Tr

aits

.

Cov

erag

e of

the

legi

slat

ion

• D

irec

tive

94-0

8 pr

ovid

es g

uida

nce

rega

rdin

g th

e su

bmis

sion

of a

n ap

plic

atio

n fo

r th

e au

thor

isat

ion

of th

e un

confi

ned

rel

ease

of a

PN

T. A

n un

confi

ned

rel

ease

invo

lves

the

rele

ase

of a

PN

T in

to th

e en

viro

nmen

t with

no

rest

rict

ions

, with

a v

iew

tow

ards

com

mer

cial

isat

ion.

199

and the Gene Technology Agreement

App

licat

ion

proc

ess

for

unco

nfi n

ed r

elea

se

of G

MO

s in

to

the

envi

ronm

ent

(usu

ally

for

the

purp

ose

of

com

mer

cial

isat

ion)

• T

he M

inis

ter

mus

t be

notifi

ed

if so

meo

ne w

ishe

s to

man

ufac

ture

or

impo

rt a

new

sub

stan

ce th

at is

no

t on

the

Dom

estic

Sub

stan

ces

List

(if i

t is

on th

e lis

t no

appr

oval

is n

eces

sary

).

• I

nfor

mat

ion

rele

vant

to th

e as

sess

men

t mus

t be

prov

ided

to th

e M

inis

ter.

• A

ll pr

opos

als

unde

rgo

a si

ngle

60-

day

publ

ic c

onsu

ltatio

n pe

riod

whe

re in

tere

sted

par

ties

may

bri

ng

forw

ard

addi

tiona

l sci

entifi

c e

vide

nce

to s

uppo

rt o

r re

fute

the

Min

iste

r’s d

ecis

ion.

• A

fter

taki

ng in

to a

ccou

nt a

ny a

dvic

e pr

ovid

ed, t

he M

inis

ter

mus

t dec

ide

whe

ther

the

subs

tanc

e is

to

xic

or c

apab

le o

f bec

omin

g to

xic.

• I

f the

Min

iste

r dec

ides

that

the

orga

nism

is n

ot to

xic

or c

apab

le o

f bec

omin

g to

xic,

the

Min

iste

r can

pl

ace

the

orga

nism

on

the

Dom

estic

Sub

stan

ce R

egis

ter b

ut c

anno

t im

pose

any

con

ditio

ns.

• I

f the

Min

iste

r de

cide

s th

at th

e or

gani

sm is

toxi

c or

cap

able

of b

ecom

ing

toxi

c, th

en th

e M

inis

ter

can:

(a) p

erm

it its

man

ufac

ture

or

impo

rtat

ion

subj

ect t

o an

y co

nditi

ons

the

Min

iste

r m

ay s

peci

fy; o

r (b

) can

pro

hibi

t its

impo

rt o

r m

anuf

actu

re.

• T

he fi

nal d

ecis

ion

of th

e M

inis

ter

mus

t be

publ

ishe

d.

• D

irec

tive

94-0

8 sp

ecifi

es th

at a

pplic

atio

ns c

onta

in in

form

atio

n th

at a

llow

s th

e Pl

ant B

iosa

fety

Offi

ce

to c

ondu

ct a

n en

viro

nmen

tal r

isk

asse

ssm

ent.

• T

he c

rite

ria

for

the

asse

ssm

ent i

nclu

de:

pote

ntia

l of t

he P

NT

to b

ecom

e a

wee

d of

agr

icul

ture

or

be in

vasi

ve o

f nat

ural

hab

itats

; pot

entia

l for

gen

e-fl o

w to

wild

rel

ativ

es w

hose

hyb

rid

offs

prin

g m

ay

beco

me

mor

e w

eedy

or

mor

e in

vasi

ve; p

oten

tial f

or th

e PN

T to

bec

ome

a pl

ant p

est;

pote

ntia

l im

pact

of t

he P

NT

or it

s ge

ne p

rodu

cts

on n

on-t

arge

t spe

cies

, inc

ludi

ng h

uman

s; p

oten

tial i

mpa

ct

on b

iodi

vers

ity. I

n co

nsid

erin

g th

e en

viro

nmen

tal s

afet

y, th

e Pl

ant B

iosa

fety

Offi

ce m

ay c

onsu

lt w

ith

scie

ntifi

c ex

pert

s.

Appendix 8

200

Statutory Review of the Gene Technology Act 2000

App

licat

ion

proc

ess

for

unco

nfi n

ed r

elea

se

of G

MO

s in

to

the

envi

ronm

ent

(usu

ally

for

the

purp

ose

of

com

mer

cial

isat

ion)

(c

ontin

ued)

• I

n ad

ditio

n, a

nd b

efor

e au

thor

isat

ion

for

rele

ase

can

be g

rant

ed, i

nfor

mat

ion

on th

e fo

llow

ing

is a

lso

requ

ired

: th

e id

entit

y an

d or

igin

of t

he P

NT;

the

prop

ertie

s of

the

nove

l gen

e an

d ge

ne p

rodu

cts;

the

rela

tive

phen

otyp

ic e

xpre

ssio

n of

the

PNT

com

pare

d to

a s

imila

r co

unte

rpar

t, w

here

diff

eren

ces

are

antic

ipat

ed; a

ntic

ipat

ed o

r kn

own

rela

tive

effe

cts

on th

e en

viro

nmen

t res

ultin

g fr

om th

e re

leas

e.

• T

he a

pplic

ant c

an a

lso

subm

it ot

her

scie

ntifi

c re

sear

ch a

s pa

rt o

f the

app

licat

ion.

Upo

n be

com

ing

awar

e of

new

info

rmat

ion

rega

rdin

g th

e en

viro

nmen

tal s

afet

y of

the

PNT

(e.g

. enh

ance

d w

eedi

ness

ch

arac

teri

stic

s), i

nclu

ding

the

risk

to h

uman

hea

lth (e

.g. e

xpos

ure

to a

llerg

ens)

that

cou

ld r

esul

t fr

om th

e re

leas

e, th

e ap

plic

ant m

ust i

mm

edia

tely

pro

vide

the

Plan

t Bio

safe

ty O

ffi ce

with

the

new

in

form

atio

n.

• T

he P

lant

Bio

safe

ty O

ffi ce

may

mai

ntai

n, c

hang

e, o

r re

mov

e ex

istin

g co

nditi

ons

resp

ectin

g th

e re

leas

e; im

pose

add

ition

al c

ondi

tions

; or

refu

se o

r ca

ncel

the

auth

oris

atio

n an

d re

quir

e th

e ap

plic

ant

to s

top

the

rele

ase

and

take

any

app

ropr

iate

act

ion

nece

ssar

y to

elim

inat

e fr

om, o

r m

inim

ise

the

risk

to

, the

env

iron

men

t.

• T

here

is a

dra

ft do

cum

ent t

hat o

utlin

es th

e ap

plic

atio

n re

quir

emen

ts fo

r no

tifi c

atio

n of

a r

elea

se o

f bi

otec

hnol

ogy-

deriv

ed li

vest

ock

anim

als.

Thi

s dr

aft a

ppea

rs to

app

ly to

con

fi ned

and

unc

onfi n

ed

rele

ases

. Inf

orm

atio

n re

quir

emen

ts in

clud

e in

form

atio

n: o

n th

e or

gani

sm; o

n th

e or

gani

sm’s

man

ufac

ture

or

impo

rt; o

n th

e in

trod

uctio

n of

the

orga

nism

; on

the

envi

ronm

enta

l fat

e of

the

orga

nism

; on

the

orga

nism

’s en

viro

nmen

tal e

ffect

s; o

n po

tent

ial a

dver

se e

ffect

s on

hum

an h

ealth

; on

test

dat

a th

at a

ssis

ts in

the

iden

tifi c

atio

n of

haz

ards

to h

uman

hea

lth a

nd e

nvir

onm

ent.

Con

side

ratio

n of

et

hica

l iss

ues

• I

n m

akin

g a

deci

sion

Min

iste

rs m

ay o

nly

dete

rmin

e w

heth

er th

e su

bsta

nce

is to

xic

or c

apab

le

of b

ecom

ing

toxi

c. N

o sp

ecifi

c m

entio

n of

eth

ics

or tr

ade

is m

ade.

How

ever

, the

Min

iste

r m

ay

take

into

acc

ount

fact

ors

such

as,

but

not

lim

ited

to s

ocia

l, ec

onom

ic a

nd te

chni

cal m

atte

rs

whe

n de

term

inin

g pr

even

tativ

e or

con

trol

act

ion

in r

elat

ion

to a

sub

stan

ce o

r in

pla

ns fo

r vi

rtua

l el

imin

atio

n of

the

subs

tanc

e.

201

and the Gene Technology Agreement

Prot

ectio

n of

co

nfi d

entia

l co

mm

erci

al

info

rmat

ion

• A

n ap

plic

ant m

ay r

eque

st th

at in

form

atio

n be

trea

ted

as c

onfi d

entia

l.

• T

he M

inis

ter

mus

t not

dis

clos

e an

y in

form

atio

n in

res

pect

of w

hich

a r

eque

st fo

r co

nfi d

entia

lity

has

been

mad

e un

less

: it

is in

the

publ

ic in

tere

st; o

r it

is d

iscl

osed

und

er a

n ag

reem

ent b

etw

een

the

Gov

ernm

ent o

f Can

ada

and

any

othe

r go

vern

men

t of C

anad

a or

gov

ernm

ent o

f a fo

reig

n st

ate

etc,

an

d th

e ag

ency

agr

ees

to k

eep

the

info

rmat

ion

confi

den

tial.

Con

ditio

ns th

at m

ay

be a

pplie

d•

Whe

re th

e M

inis

ter

susp

ects

that

a li

ving

org

anis

m is

toxi

c or

cap

able

of b

eing

toxi

c, th

e M

inis

ter

for

the

Envi

ronm

ent m

ay p

erm

it th

e m

anuf

actu

re o

r im

port

of t

he li

ving

org

anis

ms

subj

ect t

o an

y co

nditi

ons

that

the

Min

iste

r m

ay s

peci

fy.

• T

he P

lant

Bio

safe

ty O

ffi ce

may

mai

ntai

n, c

hang

e, o

r re

mov

e ex

istin

g co

nditi

ons

resp

ectin

g th

e re

leas

e; im

pose

add

ition

al c

ondi

tions

; or

refu

se o

r ca

ncel

the

auth

oris

atio

n an

d re

quir

e th

e ap

plic

ant

to s

top

the

rele

ase

and

take

any

app

ropr

iate

act

ion

nece

ssar

y to

elim

inat

e fr

om, o

r m

inim

ise

the

risk

to

, the

env

iron

men

t.

Mon

itori

ng,

surv

eilla

nce

and

enfo

rcem

ent p

ower

s

• M

onito

ring

and

enf

orce

men

t pow

ers

are

the

sam

e as

thos

e de

scri

bed

abo

ve b

ecau

se u

ncon

fi ned

re

leas

es a

re g

over

ned

by th

e sa

me

legi

slat

ion

as c

onfi n

ed r

elea

ses.

Pena

lties

• P

enal

ties

that

may

be

impo

sed

in r

elat

ion

to u

ncon

fi ned

rel

ease

are

the

sam

e as

thos

e de

scri

bed

for

the

Feed

s A

ct fo

r co

nfi n

ed r

elea

ses

beca

use

unco

nfi n

ed r

elea

ses

are

gove

rned

by

the

sam

e le

gisl

atio

n as

con

fi ned

rel

ease

s.

Plac

ing

on t

he m

arke

t G

MO

s fo

r fo

od o

r fe

ed

Legi

slat

ion

• F

ood

and

Dru

gs A

ct.

• F

eeds

Act

and

am

endm

ents

and

reg

ulat

ions

.

• D

irec

tive

95-0

3.

Appendix 8

202

Statutory Review of the Gene Technology Act 2000

Cov

erag

e of

le

gisl

atio

n•

The

Foo

d an

d D

rugs

Act

reg

ulat

es th

e us

e of

GM

Os

(der

ived

from

pla

nt a

nd a

nim

al s

ourc

es) t

hat a

re

inte

nded

for

use

as n

ovel

food

s.

• T

he F

eeds

Act

gov

erns

the

use

of fe

ed w

ithin

Can

ada

and

ensu

res

that

it is

saf

e to

use

.

• D

irec

tive

95-0

3 ap

pear

s as

thou

gh it

can

be

used

for

appl

ying

for

rele

ase

of n

ovel

feed

(pla

nt s

ourc

e)

for

even

tual

com

mer

cial

isat

ion.

App

licat

ion

proc

ess

for

unco

nfi n

ed r

elea

se

of G

MO

s in

to th

e en

viro

nmen

t for

use

as

feed

for

lives

tock

an

d la

bora

tory

an

imal

s (u

sual

ly

for

the

purp

ose

of

com

mer

cial

isat

ion)

• U

nder

the

Feed

s A

ct a

nd it

s am

endm

ents

and

reg

ulat

ions

a w

ritte

n no

tifi c

atio

n of

the

prop

osed

re

leas

e m

ust b

e m

ade

to th

e M

inis

ter,

incl

udin

g in

form

atio

n su

ch a

s: t

he p

artic

ular

s of

the

rele

ase;

co

nfi n

emen

t and

mon

itori

ng p

roce

dure

s; m

etho

ds fo

r sa

fe d

ispo

sal;

cont

inge

ncy

plan

s to

miti

gate

ad

vers

e ef

fect

s on

hum

ans

and

the

envi

ronm

ent i

n th

e ev

ent o

f acc

iden

tal r

elea

se; t

he p

artic

ular

s of

th

e no

vel t

rait;

any

res

ults

from

dat

a or

res

earc

h do

ne to

iden

tify

risk

s to

the

envi

ronm

ent o

r hu

man

he

alth

. Th

e M

inis

ter

for A

gric

ultu

re a

nd A

gri-

food

s ca

n th

en e

ither

aut

hori

se o

r re

fuse

to a

utho

rise

th

e re

leas

e of

the

nove

l fee

d an

d sh

all c

onsi

der

the

mag

nitu

de o

f exp

osur

e of

the

rele

ase,

the

effe

cts

on th

e en

viro

nmen

t and

whe

ther

the

nove

l fee

d is

toxi

c. T

he a

pplic

atio

n sh

all b

e ac

com

pani

ed w

ith

evid

ence

(suc

h as

sci

entifi

c r

esea

rch)

to p

erm

it an

ass

essm

ent o

r ev

alua

tion

of th

e sa

fety

and

effi

cacy

of

the

feed

in r

espe

ct o

f liv

esto

ck a

nd it

s po

tent

ial e

ffect

on

hum

ans

and

on th

e en

viro

nmen

t.

• D

irect

ive

95-0

3 pr

ovid

es th

e gu

idel

ines

for t

he c

ompl

etio

n of

an

appl

icat

ion

for t

he u

ncon

fi ned

rel

ease

of

a n

ovel

feed

from

pla

nt s

ourc

es.

App

licat

ions

sho

uld

cont

ain:

suffi c

ient

dat

a ab

out t

he n

ovel

trai

t; in

form

atio

n ab

out t

he m

odifi

catio

n hi

stor

y; c

hara

cter

isat

ion

of th

e D

NA

inse

rted,

if a

ny; n

utrit

iona

l da

ta, a

llerg

enic

ity d

ata;

toxi

colo

gy d

ata;

die

tary

exp

osur

e; la

bora

tory

ani

mal

/live

stoc

k fe

edin

g tri

al

data

; env

ironm

enta

l ris

k as

sess

men

t; m

etho

d of

det

ectio

n. A

dec

isio

n is

then

mad

e on

the

info

rmat

ion

prov

ided

in th

e ap

plic

atio

n.

• Th

e ap

plic

atio

n pr

oced

ure

and

info

rmat

ion

requ

irem

ents

for r

elea

sing

of a

nov

el fe

ed o

f an

anim

al o

rigin

is

sim

ilar t

o th

at fo

r a n

ovel

feed

from

a p

lant

sou

rce

and

is o

utlin

ed in

the

Feed

s Act

and

regu

latio

ns.

203

and the Gene Technology Agreement

App

licat

ion

proc

ess

for

unco

nfi n

ed r

elea

se

of G

MO

s in

to th

e en

viro

nmen

t for

use

as

feed

for

lives

tock

an

d la

bora

tory

an

imal

s (u

sual

ly

for

the

purp

ose

of

com

mer

cial

isat

ion)

(c

ontin

ued)

• T

here

is a

dra

ft do

cum

ent t

hat o

utlin

es th

e ap

plic

atio

n re

quir

emen

ts fo

r no

tifi c

atio

n of

a r

elea

se o

f bi

otec

hnol

ogy-

deriv

ed li

vest

ock

anim

als.

Thi

s dr

aft a

ppea

rs to

app

ly to

con

fi ned

and

unc

onfi n

ed

rele

ases

. In

form

atio

n re

quir

emen

ts in

clud

e in

form

atio

n: o

n th

e or

gani

sm; o

n th

e or

gani

sm’s

man

ufac

ture

or

impo

rt; o

n th

e in

trod

uctio

n of

the

orga

nism

; on

the

envi

ronm

enta

l fat

e of

the

orga

nism

; on

the

orga

nism

’s en

viro

nmen

tal e

ffect

s; o

n po

tent

ial a

dver

se e

ffect

s on

hum

an h

ealth

; on

test

dat

a th

at a

ssis

ts in

the

iden

tifi c

atio

n of

haz

ards

to h

uman

hea

lth a

nd e

nvir

onm

ent.

Con

side

ratio

n of

et

hica

l iss

ues

• I

n m

akin

g a

deci

sion

Min

iste

rs m

ay o

nly

dete

rmin

e w

heth

er th

e su

bsta

nce

is to

xic

or c

apab

le

of b

ecom

ing

toxi

c. N

o sp

ecifi

c m

entio

n of

eth

ics

or tr

ade

is m

ade.

How

ever

, the

Min

iste

r m

ay

take

into

acc

ount

fact

ors

such

as,

but

not

lim

ited

to s

ocia

l, ec

onom

ic a

nd te

chni

cal m

atte

rs

whe

n de

term

inin

g pr

even

tativ

e or

con

trol

act

ion

in r

elat

ion

to a

sub

stan

ce o

r in

pla

ns fo

r vi

rtua

l el

imin

atio

n of

the

subs

tanc

e.

Prot

ectio

n of

co

nfi d

entia

l co

mm

erci

al

info

rmat

ion

• A

n ap

plic

ant m

ay r

eque

st th

at in

form

atio

n be

trea

ted

as c

onfi d

entia

l.

• T

he M

inis

ter

mus

t not

dis

clos

e an

y in

form

atio

n in

res

pect

of w

hich

a r

eque

st fo

r co

nfi d

entia

lity

has

been

mad

e un

less

: it

is in

the

publ

ic in

tere

st; o

r it

is d

iscl

osed

und

er a

n ag

reem

ent b

etw

een

the

Gov

ernm

ent o

f Can

ada

and

any

othe

r go

vern

men

t of C

anad

a or

gov

ernm

ent o

f a fo

reig

n st

ate

etc,

an

d th

e ag

ency

agr

ees

to k

eep

the

info

rmat

ion

confi

den

tial.

Con

ditio

ns th

at m

ay

be a

pplie

d•

The

Pla

nt B

iosa

fety

Offi

ce m

ay m

aint

ain,

cha

nge,

or

rem

ove

exis

ting

cond

ition

s re

spec

ting

the

rele

ase;

impo

se a

dditi

onal

con

ditio

ns; o

r re

fuse

or

canc

el th

e au

thor

isat

ion

and

requ

ire

the

appl

ican

t to

sto

p th

e re

leas

e an

d ta

ke a

ny a

ppro

pria

te a

ctio

n ne

cess

ary

to e

limin

ate

from

, or

min

imis

e th

e ri

sk

to, t

he e

nvir

onm

ent.

Appendix 8

204

Statutory Review of the Gene Technology Act 2000

Mon

itori

ng,

surv

eilla

nce

and

enfo

rcem

ent p

ower

s

• M

onito

ring

and

enf

orce

men

t pow

ers

are

the

sam

e as

thos

e de

scri

bed

in th

e ab

ove

tabl

e be

caus

e un

confi

ned

rel

ease

s ar

e go

vern

ed b

y th

e sa

me

legi

slat

ion

as c

onfi n

ed r

elea

ses.

Pena

lties

• P

enal

ties

that

may

be

impo

sed

in r

elat

ion

to u

ncon

fi ned

rel

ease

of G

MO

s in

tend

ed fo

r fe

ed u

se

are

the

sam

e as

thos

e de

scri

bed

for

the

Feed

s A

ct fo

r co

nfi n

ed r

elea

ses

beca

use

rele

ase

of G

MO

s in

tend

ed fo

r fe

ed u

se a

re g

over

ned

by th

e sa

me

legi

slat

ion

as c

onfi n

ed r

elea

ses.

App

licat

ion

proc

ess

for

unco

nfi n

ed r

elea

se

of G

MO

s in

to th

e en

viro

nmen

t for

use

as

food

for

hum

an

cons

umpt

ion

(usu

ally

for

the

purp

ose

of

com

mer

cial

isat

ion)

• N

o no

vel f

ood

may

be

sold

or

adve

rtis

ed w

ithou

t fi r

st s

ubm

ittin

g a

notifi

cat

ion

for

the

inte

ntio

n to

do

so to

the

deci

sion

mak

er.

• T

he n

otifi

catio

n re

quir

es th

e fo

llow

ing

info

rmat

ion:

det

ails

of t

he fo

od, i

nclu

ding

info

rmat

ion

conc

erni

ng it

s de

velo

pmen

t; de

tails

of t

he m

etho

d by

whi

ch it

is m

anuf

actu

red,

pre

pare

d, p

rese

rved

, pa

ckag

ed a

nd s

tore

d; d

etai

ls o

f the

maj

or c

hang

e, if

any

; inf

orm

atio

n co

ncer

ning

its

inte

nded

use

an

d di

rect

ions

for

its p

repa

ratio

n; in

form

atio

n co

ncer

ning

its

hist

ory

of u

se a

s a

food

; inf

orm

atio

n re

lied

on to

est

ablis

h th

at th

e no

vel f

ood

is s

afe

for

cons

umpt

ion;

the

estim

ated

con

sum

ptio

n le

vel o

f th

e no

vel f

ood.

• U

pon

rece

ivin

g th

e in

form

atio

n, th

e de

cisi

on m

aker

sha

ll, w

ithin

45

days

, not

ify th

e ap

plic

ant

that

the

info

rmat

ion

prov

ided

is s

uffi c

ient

if th

e fo

od is

saf

e, o

r re

ques

t fur

ther

info

rmat

ion.

Upo

n re

ceiv

ing

the

addi

tiona

l inf

orm

atio

n, th

e de

cisi

on m

aker

sha

ll no

tify

the

appl

ican

t with

in 9

0 da

ys

that

the

info

rmat

ion

was

suffi c

ient

if th

e fo

od is

saf

e.

• Th

e no

vel f

ood

mus

t und

ergo

num

erou

s sa

fety

ass

essm

ents

bef

ore

bein

g ap

prov

ed fo

r use

as

food

. Th

is

may

incl

ude

usin

g da

ta fr

om a

nim

al s

tudi

es o

r tria

ls re

gard

ing

its to

xici

ty a

nd a

llerg

enic

ity.

• I

n ev

alua

ting

GM

food

s fo

r sa

fety

, gov

ernm

ent s

cien

tifi c

eva

luat

ors

may

con

side

r th

e fo

llow

ing:

how

th

e fo

od c

rop

was

dev

elop

ed, i

nclu

ding

the

chan

ges

in th

e pl

ant’s

/ani

mal

’s m

olec

ular

str

uctu

re; h

ow

the

GM

food

com

pare

s w

ith it

s co

nven

tiona

l cou

nter

part

; whe

ther

the

GM

food

con

tain

s ne

w to

xins

(to

ani

mal

s, h

uman

s an

d th

e en

viro

nmen

t); w

heth

er th

e G

M fo

od m

ay c

ause

alle

rgie

s.

205

and the Gene Technology Agreement

Con

side

ratio

n of

et

hica

l iss

ues

• N

o sp

ecifi

c m

entio

n of

this

was

foun

d in

the

rele

vant

legi

slat

ion.

Prot

ectio

n of

co

nfi d

entia

l co

mm

erci

al

info

rmat

ion

• N

o sp

ecifi

c m

entio

n of

this

was

foun

d in

the

Food

and

Dru

gs A

ct o

r its

reg

ulat

ions

, or

in th

e dr

aft

guid

elin

es fo

r no

tifi c

atio

n fo

r th

e in

tend

ed r

elea

se o

f bio

tech

nolo

gy-d

eriv

ed a

nim

als.

Con

ditio

ns th

at m

ay

be a

pplie

d•

The

re w

as n

o m

entio

n of

spe

cifi c

con

ditio

ns r

equi

red

to b

e m

et o

ther

than

thos

e re

quir

ed w

hen

an

appl

icat

ion/

notifi

cat

ion

for

the

nove

l foo

d to

be

plac

ed o

n th

e m

arke

t is

mad

e.

Mon

itori

ng,

surv

eilla

nce

and

enfo

rcem

ent p

ower

s

• T

he F

ood

and

Dru

gs A

ct h

as p

rovi

sion

s th

at a

llow

an

insp

ecto

r fr

om th

e C

anad

ian

Food

Insp

ectio

n A

genc

y to

con

duct

insp

ectio

ns.

An

insp

ecto

r m

ay, a

t any

rea

sona

ble

time,

ent

er g

roun

ds w

here

the

insp

ecto

r be

lieve

s on

rea

sona

ble

grou

nds

any

artic

le to

whi

ch th

is A

ct o

r th

e re

gula

tions

app

ly is

m

anuf

actu

red,

pre

pare

d, p

rese

rved

, pac

kage

d or

sto

red

to:

exam

ine

and

take

sam

ples

of a

rtic

les;

op

en a

nd e

xam

ine

rece

ptac

les

or p

acka

ges;

exa

min

e or

mak

e co

pies

of d

ocum

ents

that

con

tain

in

form

atio

n re

leva

nt to

the

enfo

rcem

ent o

f the

Act

; sei

ze a

nd d

etai

n ar

ticle

s.

Pena

lties

• P

erso

ns w

ho c

ontr

aven

e th

e Fo

od a

nd D

rugs

Act

: on

a s

umm

ary

conv

ictio

n fo

r a fi r

st o

ffenc

e m

ay

face

a fi

ne o

f no

mor

e th

an C

A$5

00 o

r a

pris

on te

rm n

o m

ore

than

thre

e m

onth

s or

bot

h; fo

r a

subs

eque

nt o

ffenc

e, a

fi ne

no

mor

e th

an C

A$1

000

or a

pri

son

term

of n

o m

ore

than

six

mon

ths

or

both

; for

a c

onvi

ctio

n on

indi

ctm

ent,

a fi n

e no

mor

e th

an C

A$5

000

or a

pri

son

term

no

mor

e th

an

thre

e ye

ars

or b

oth.

Appendix 8

206

Statutory Review of the Gene Technology Act 2000

Polic

y an

d G

over

nanc

e is

sues

Liab

ility

for

cont

amin

atio

nTh

e C

EPA

pro

vide

s fo

r tw

o ty

pes

of a

ctio

n:

(1) E

nvir

onm

enta

l Pro

tect

ion

Act

ions

.

A

ny C

anad

ian

citiz

en c

an a

pply

for

an in

vest

igat

ion

of a

n al

lege

d of

fenc

e in

con

trav

entio

n of

the

legi

slat

ion

— th

is is

cal

led

an ‘E

nvir

onm

enta

l Pro

tect

ion

Act

ion’

(EPA

). A

n EP

A c

an o

nly

be b

ough

t if:

(a) t

he M

inis

ters

inve

stig

atio

n w

as in

adeq

uate

or

non-

exis

tent

; and

(b) t

here

was

an

alle

ged

brea

ch o

f the

Act

; and

(c) t

he a

llege

d br

each

is c

ausi

ng s

ignifi c

ant h

arm

to th

e en

viro

nmen

t.

A

n EP

A m

ay n

ot b

e bo

ught

if th

e al

lege

d co

nduc

t was

:

(a) t

aken

to c

orre

ct o

r miti

gate

har

m o

r ris

k of

har

m to

the

envi

ronm

ent o

r hum

an p

lant

or a

nim

al li

fe;

(b) t

aken

to p

rote

ct n

atio

nal s

ecur

ity; o

r (c

) was

rea

sona

ble

and

cons

iste

nt w

ith p

ublic

saf

ety.

D

efen

ces

to a

n EP

A in

clud

e:

(a) d

ue d

ilige

nce;

(b) a

utho

risa

tion

by a

noth

er a

ct o

f par

liam

ent;

(c) a

n offi c

ially

indu

ced

mis

take

of l

aw; a

nd

(d) a

ny o

ther

def

ence

s av

aila

ble

unde

r ge

nera

l law

.

In

add

ition

, an

actio

n m

ay b

e di

smis

sed

if it

is n

ot in

the

publ

ic in

tere

st. T

he o

nly

relie

f tha

t is

avai

labl

e if

an E

PA is

suc

cess

ful i

s an

inju

nctio

n (s

topp

ing

the

defe

ndan

t fro

m d

oing

som

ethi

ng o

r fo

rcin

g th

em to

do

som

ethi

ng) o

r an

ord

er to

the

part

ies

to n

egot

iate

a p

lan

to c

orre

ct o

r m

itiga

te th

e ha

rm to

the

envi

ronm

ent e

tc, c

osts

of t

he a

ctio

n. T

here

can

be

no a

war

d of

dam

ages

in th

e ev

ent o

f a

succ

essf

ul E

PA.

Th

is a

ctio

n do

es n

ot a

ssis

t ind

ivid

uals

affe

cted

by

cont

amin

atio

n to

see

k da

mag

es fo

r lo

ss s

uffe

red;

ra

ther

it e

nabl

es th

em to

bri

ng a

n ac

tion

if th

ere

has

been

a b

reac

h of

the

Act

, to

stop

the

activ

ity

cont

inui

ng.

207

and the Gene Technology Agreement

Liab

ility

for

cont

amin

atio

n (c

ontin

ued)

(2) C

omm

on la

w a

ctio

ns

Th

e A

ct e

xplic

itly

reite

rate

s th

e co

mm

on la

w r

ight

for

a th

ird

part

y w

ho h

as s

uffe

red

dam

age

to g

o to

cou

rt to

see

k da

mag

es fo

r su

ch lo

ss.

The

actio

n th

at m

ay b

e br

ough

t (an

d th

e da

mag

es a

ble

to

be r

ecov

ered

) will

dep

end

entir

ely

on th

e ap

plic

atio

n of

ord

inar

y pr

inci

ples

of l

aw (f

or e

xam

ple,

nu

isan

ce, n

eglig

ence

). Th

e C

anad

ian

Envi

ronm

ent P

rote

ctio

n A

ct d

oes

not e

stab

lish

any

stat

utor

y ri

ght t

o re

cove

r fo

r lo

ss o

r da

mag

e. T

here

is a

str

ict l

iabi

lity

arra

ngem

ent i

n th

e C

EPA

199

9 w

here

th

e pe

rson

who

ow

ns o

r ha

s th

e ch

arge

, man

agem

ent o

r co

ntro

l of a

sub

stan

ce im

med

iate

ly b

efor

e an

env

iron

men

tal e

mer

genc

y is

liab

le:

– fo

r re

stor

ing

any

part

of t

he e

nvir

onm

ent d

amag

ed b

y or

dur

ing

the

emer

genc

y; a

nd

– fo

r co

sts

and

expe

nses

incu

rred

by

a pu

blic

dep

artm

ent i

n re

spec

t of m

easu

res

take

n to

pre

vent

, re

pair,

rem

edy

or m

inim

ise

the

dam

age

to th

e en

viro

nmen

t res

ultin

g fr

om th

e e

mer

genc

y,

incl

udin

g m

easu

res

take

n in

ant

icip

atio

n of

the

envi

ronm

enta

l em

erge

ncy;

as

the

pers

on’s

liabi

lity

does

not

dep

end

on p

roof

of f

ault

or n

eglig

ence

.

H

owev

er, t

he p

erso

n’s

stri

ct li

abili

ty m

ay b

e re

duce

d or

nul

lifi e

d if

the

pers

on c

an s

how

that

th

e em

erge

ncy

was

cau

sed

by: a

n ac

t of w

ar; a

n ex

cept

iona

l, ir

resi

stib

le a

nd in

evita

ble

natu

ral

phen

omen

on; a

thir

d pa

rty

with

the

inte

nt to

cau

se d

amag

e; n

eglig

ence

or

wro

ngfu

l act

of

gove

rnm

ent,

publ

ic d

epar

tmen

t or

auth

ority

.

Expe

rt c

omm

ittee

s•

Can

adia

n B

iote

chno

logy

Adv

isor

y C

omm

ittee

(CBA

C):

is a

non

-sta

tuto

ry c

omm

ittee

est

ablis

hed

by

the

fede

ral g

over

nmen

t to

prov

ide

advi

ce to

a C

oord

inat

ing

Com

mitt

ee o

f fed

eral

min

iste

rs o

n br

oad

polic

y is

sues

ass

ocia

ted

with

the

ethi

cal,

soci

al, r

egul

ator

y, e

cono

mic

, sci

entifi

c, e

nvir

onm

enta

l an

d he

alth

asp

ects

of b

iote

chno

logy

. CBA

C is

mad

e up

of 1

2 m

embe

rs d

raw

n fr

om th

e sc

ient

ifi c,

bu

sine

ss, g

ener

al p

ublic

, eth

ics

and

envi

ronm

enta

l com

mun

ities

.

• T

he C

EPA

est

ablis

hes

a N

atio

nal A

dvis

ory

Com

mitt

ee th

at c

an p

rovi

de b

oth

tech

nica

l and

pol

icy

advi

ce to

the

Min

iste

r on

: pro

pose

d re

gula

tions

for

toxi

c su

bsta

nces

; pro

pose

d re

gula

tions

on

envi

ronm

enta

l em

erge

ncie

s; a

co-

oper

ativ

e co

ordi

nate

d ap

proa

ch to

the

man

agem

ent o

f tox

ic

subs

tanc

es; a

nd a

ny o

ther

mat

ter

of m

utua

l int

eres

t.

• T

his

Com

mitt

ee lo

oks

at a

ll en

viro

nmen

tal i

ssue

s no

t jus

t bio

tech

nolo

gy.

Appendix 8

208

Statutory Review of the Gene Technology Act 2000

Res

earc

h•

The

Min

iste

r fo

r th

e En

viro

nmen

t and

Min

iste

r fo

r H

ealth

mus

t bot

h un

dert

ake

rese

arch

and

stu

dies

in

to e

nvir

onm

enta

l con

tam

inat

ion

aris

ing

from

dis

turb

ance

s of

eco

syst

ems

by h

uman

act

ivity

, and

th

e ro

le o

f sub

stan

ces

in il

lnes

ses

or h

ealth

pro

blem

s, r

espe

ctiv

ely.

The

Min

iste

r fo

r th

e En

viro

nmen

t an

d th

e M

inis

ter

for

Hea

lth m

ay c

olle

ct o

r ge

nera

te d

ata

and

cond

uct i

nves

tigat

ions

res

pect

ing

any

mat

ter

in r

elat

ion

to a

sub

stan

ce w

hen

asse

ssin

g w

heth

er a

sub

stan

ce is

toxi

c.

Oth

er

The

prec

autio

nary

pr

inci

ple

• T

he p

ream

ble

to C

EPA

sta

tes

that

‘whe

reas

the

Gov

ernm

ent o

f Can

ada

is c

omm

itted

to im

plem

entin

g th

e pr

ecau

tiona

ry p

rinc

iple

that

, whe

re th

ere

are

thre

ats

of s

erio

us o

r ir

reve

rsib

le d

amag

e, la

ck o

f ful

l sc

ient

ifi c

cert

aint

y sh

all n

ot b

e us

ed a

s a

reas

on fo

r po

stpo

ning

cos

t-ef

fect

ive

mea

sure

s to

pre

vent

en

viro

nmen

tal d

amag

e.

• I

n gi

ving

adv

ice

and

reco

mm

enda

tions

to th

e M

inis

ter,

the

Nat

iona

l Adv

isor

y C

omm

ittee

sha

ll us

e th

e pr

ecau

tiona

ry p

rinc

iple

.

Cos

t rec

over

y•

Fee

s ar

e at

tach

ed to

not

ifi ca

tions

to th

e re

leva

nt g

over

nmen

t dep

artm

ents

for

prop

osed

use

of n

ovel

pl

ants

, fee

d or

food

. The

Can

adia

n G

over

nmen

t may

als

o re

cove

r al

l cos

ts o

f, an

d in

cide

ntal

to,

taki

ng r

easo

nabl

e m

easu

res

to p

reve

nt r

elea

ses

that

end

ange

r th

e en

viro

nmen

t and

pub

lic s

afet

y, o

r to

rem

edy

any

dang

erou

s si

tuat

ion

or r

educ

e or

miti

gate

any

dan

ger

to th

e en

viro

nmen

t or

to h

uman

lif

e th

at r

esul

ts, o

r m

ay r

esul

t, fr

om th

e re

leas

e of

a to

xic

subs

tanc

e in

bre

ach

of c

ondi

tions

(alth

ough

th

ere

is a

5 y

ear

limita

tion

peri

od).

Mor

ator

ium

• N

o m

orat

oriu

m.

Oth

er•

Can

ada

is c

urre

ntly

pro

posi

ng a

reg

ulat

ion

unde

r th

e C

EPA

(199

9) th

at w

ould

allo

w C

anad

a to

im

plem

ent t

he C

arte

gena

pro

toco

l. H

owev

er, l

ivin

g m

odifi

ed o

rgan

ism

s th

at a

re p

harm

aceu

tical

s fo

r hu

man

use

are

exc

lude

d fr

om th

e re

gula

tion.

• A

nov

el fe

ed fr

om a

PN

T th

at c

ould

rea

sona

bly

be e

xpec

ted

to b

e re

leas

ed in

to th

e en

viro

nmen

t or

used

as

food

will

not

be

auth

oris

ed fo

r liv

esto

ck fe

ed u

se u

ntil:

the

Pla

nt B

iosa

fety

Offi

ce, C

FIA

, is

read

y to

aut

hori

se th

e PN

T fo

r en

viro

nmen

tal r

elea

se; t

he N

ovel

Foo

ds S

ectio

n, H

ealth

Can

ada,

is

read

y to

pro

vide

not

ifi ca

tion

of n

o ob

ject

ion

for

hum

an fo

od u

se o

f the

nov

el fo

od.

209

and the Gene Technology Agreement

RE

GU

LA

TIO

N O

F G

EN

E T

EC

HN

OL

OG

Y I

N A

RG

EN

TIN

A

SUM

MA

RY —

The

Sec

reta

ria

de A

gric

ultu

ra, G

anad

eria

, Pes

ca y

Alim

ento

s (S

AG

PyA

)/Sec

reta

ry o

f Agr

icul

ture

, Liv

esto

ck,

Fish

erie

s an

d Fo

od is

res

pons

ible

for

gran

ting

licen

ces

to d

ealin

gs w

ith G

MO

s. S

AG

PyA

bas

es it

s de

cisi

ons

on th

e re

com

men

datio

n of

an

expe

rt c

omm

ittee

: Com

isió

n N

acio

nal A

seso

ra d

e B

iote

cnol

ogía

Agr

opec

uari

a (C

ON

AB

IA)/T

he

Nat

iona

l Adv

isor

y C

omm

ittee

on

Agr

icul

tura

l Bio

safe

ty.

• T

hese

rul

es a

re p

art o

f the

gen

eral

reg

ulat

ory

syst

em g

over

ning

the

agri

cultu

ral e

xist

ing

regu

latio

ns in

Arg

entin

a re

late

d to

pla

nt p

rote

ctio

n (D

ecre

e-La

w o

f Agr

icul

tura

l Pro

duct

ion

Hea

lth D

efen

se. N

° 67

04/6

6 an

d its

am

endm

ents

), se

eds

and

phyt

ogen

etic

cre

atio

ns (S

eed

and

Phyt

ogen

etic

Cre

atio

ns L

aw, N

º 20

.247

/73

and

its r

egul

ator

y D

ecre

e), a

nd a

nim

al h

ealth

(L

aw o

f Vet

erin

aria

n Pr

oduc

ts.

Supe

rvis

ion

of th

e cr

eatio

n an

d co

mm

erci

alis

atio

n. N

º 13

.636

/49)

.

Con

tain

ed w

ork

wit

h G

MO

s

Res

pons

ible

age

ncy

• C

ON

AB

IA/S

AG

PyA

.

Legi

slat

ion

• R

esol

utio

n N

°31/

03 o

f SA

GPy

A 1

1 Ju

ly 2

003

spec

ifi es

the

appl

icat

ion

proc

edur

e fo

r th

e is

sue

of li

cenc

es fo

r Ex

peri

men

tatio

n on

and

/ or

Rel

ease

into

the

Envi

ronm

ent o

f Gen

etic

ally

M

odifi

ed M

icro

-org

anis

ms

and/

or th

eir

prod

ucts

for

use

in a

nim

als;

the

rele

ase

of g

enet

ical

ly

mod

ifi ed

ani

mal

s ar

e re

gula

ted

by R

esol

utio

n N

°656

of S

AG

PyA

11

July

200

3.

Inte

ntio

nal r

elea

ses

of G

MO

s in

the

env

iron

men

t

Res

pons

ible

age

ncy

• C

ON

AB

IA/S

AG

PyA

. C

omm

erci

al r

elea

ses

are

also

ass

esse

d by

Hea

lth, T

rade

and

See

d ag

enci

es.

Legi

slat

ion

• F

ield

tria

ls a

re g

over

ned

unde

r R

esol

utio

n N

°57

of S

AG

PyA

18

July

, 200

3; c

omm

erci

al

rele

ases

are

als

o su

bjec

t to

SAG

PyA

Reg

ulat

ion

No.

511

/98

as w

ell a

s ge

nera

l see

d an

d he

alth

law

s.

Cov

erag

e of

the

legi

slat

ion

• T

he d

elib

erat

e re

leas

e of

GM

Os

into

the

envi

ronm

ent.

Appendix 8

210

Statutory Review of the Gene Technology Act 2000

Ass

essm

ent p

roce

ss fo

r in

tent

iona

l rel

ease

s of

a

GM

O in

to th

e en

viro

nmen

t (fi

eld

tria

ls)

• I

nfor

mat

ion

requ

irem

ents

for

appl

icat

ions

are

bas

ed o

n th

e U

S D

epar

tmen

t of A

gric

ultu

re’s

expe

rien

ce.

CO

NA

BIA

’s te

chni

cal s

taff

mak

e a

prel

imin

ary

revi

ew o

f the

app

licat

ions

for

com

plet

enes

s an

d da

ta q

ualit

y. T

he C

ON

AB

IA c

omm

ittee

then

und

erta

kes

a ri

sk a

sses

smen

t an

alys

is. T

he r

isk

asse

ssm

ent i

nclu

des:

– as

sess

men

t of t

he b

iosa

fety

of t

he r

elea

sed

orga

nism

s;

– as

sess

men

t of t

he a

gro-

ecol

ogic

al fe

atur

es o

f the

site

whe

re th

ey a

re in

tend

ed to

be

rele

ased

; and

– su

itabi

lity

of th

e pe

rson

(s) r

espo

nsib

le fo

r co

nduc

ting

the fi e

ld tr

ial.

• A

utho

risa

tions

for fi e

ld tr

ials

are

then

issu

ed b

y SA

GPy

A b

ased

on

CO

NA

BIA

’s re

com

men

datio

n.

• A

fter

at le

ast o

ne fi

eld

tria

l and

the

safe

ty o

f the

GM

O h

as b

een

dem

onst

rate

d, a

n ap

plic

ant

can

appl

y fo

r m

ore fl e

xibl

e fi e

ld tr

ial c

ondi

tions

for

that

GM

O r

efer

red

to a

s ‘fl

exib

iliza

ción

’ (S

AG

PyA

Res

olut

ion

131/

98).

Afte

r SA

GPy

A g

rant

s fl e

xibi

lizac

ión,

furt

her

rele

ases

into

the

envi

ronm

ent o

f tha

t GM

O w

ill o

nly

need

the

appl

ican

t to

subm

it in

form

atio

n on

:

–

the

area

sow

n;

–

the

date

of s

owin

g; a

nd

–

the

site

of r

elea

se a

nd th

e ha

rves

t dat

e.

Proc

edur

e fo

r th

e pl

acin

g of

GM

Os

or p

rodu

cts

cont

aini

ng G

MO

s on

the

mar

ket

• A

fl ex

ibili

zaci

ón p

erm

it is

als

o th

e fi r

st s

tage

to g

et a

ppro

val f

or a

com

mer

cial

rel

ease

. In

addi

tion,

see

d co

mm

erci

alis

atio

n is

sub

ject

to th

e fo

llow

ing

term

s an

d co

nditi

ons:

• N

atio

nal S

ervi

ce o

f Agr

ifood

Hea

lth a

nd Q

ualit

y ap

prov

al fo

r us

e as

food

or

feed

. Th

is is

as

sess

ed b

y an

alys

is o

f: (1

) nat

ural

toxi

ns; (

2) n

ew fo

rms

of to

xins

; (3)

hom

olog

y of

the

new

ly

expr

esse

d pr

otei

ns w

ith o

ther

kno

wn

alle

rgen

s; (4

) nut

ritio

nal c

hang

es; (

5) n

utri

tiona

l cha

nges

an

d nu

triti

onal

cha

ract

eris

atio

n re

sulti

ng fr

om p

roce

ssin

g m

etho

ds; (

6) m

odifi

catio

ns in

the

bioa

vaila

bilit

y of

mac

ronu

trie

nts

and/

or m

icro

nutr

ient

s; (7

) cha

ract

eris

atio

n of

the

mod

ifi ed

fo

odst

uff w

ith r

egar

d to

its

safe

ty fo

r hu

man

and

ani

mal

hea

lth.

211

and the Gene Technology Agreement

Proc

edur

e fo

r th

e pl

acin

g of

GM

Os

or p

rodu

cts

cont

aini

ng G

MO

s on

the

mar

ket (

cont

inue

d)

• A

ppro

val f

or m

arke

ting

by th

e N

atio

nal D

ivis

ion

of A

grifo

od M

arke

ts o

f the

Sec

reta

riat

, w

hich

ass

esse

s th

e tr

ade

and

mar

ketin

g im

pact

s. T

his

asse

ssm

ent s

eeks

to a

void

any

pot

entia

l ne

gativ

e im

pact

on

Arg

entin

e ex

port

s.

• C

ompl

ianc

e w

ith th

e re

quir

emen

ts s

et fo

rth

by th

e IN

ASE

for

regi

stra

tion

of th

e m

ater

ial i

n th

e N

atio

nal C

ultiv

ar R

egis

try

and

in th

e O

ffi ci

al C

ertifi

cat

ion

regu

latio

ns.

• A

s w

ith fi

eld

tria

ls th

e fi n

al a

ppro

val i

s m

ade

by S

AG

PyA

.

Con

side

ratio

n of

eth

ical

is

sues

• T

here

is n

o sp

ecifi

c m

entio

n m

ade

of c

onsi

dera

tion

of e

thic

al c

once

rns.

Publ

ic c

onsu

ltatio

n on

ap

plic

atio

ns•

The

re is

no

spec

ifi c

men

tion

of p

ublic

con

sulta

tion

on a

pplic

atio

ns.

Ann

ual r

epor

ts a

nd

deta

ils o

f GM

Os

appr

oved

are

list

ed o

n C

ON

AB

IA’s

web

site

.

Con

ditio

ns th

at m

ay b

e ap

plie

d•

The

Res

olut

ion

prov

ides

that

com

pete

nt a

utho

ritie

s m

ay g

rant

app

rova

ls s

ubje

ct to

con

ditio

ns.

Mon

itori

ng, s

urve

illan

ce

and

enfo

rcem

ent p

ower

s•

Mon

itori

ng o

f the

fi el

d tr

ials

is th

e re

spon

sibi

lity

of th

e N

atio

nal S

eeds

Inst

itute

and

of t

he

Nat

iona

l Ser

vice

of A

grifo

od H

ealth

and

Qua

lity.

The

pur

pose

s of

the

mon

itori

ng a

re th

e on

-si

te v

erifi

catio

n of

com

plia

nce

with

the

tria

l con

ditio

ns a

s ap

prov

ed in

the

appl

icat

ion

and

that

the

mea

sure

s ta

ken

to a

void

adv

erse

effe

cts

on th

e en

viro

nmen

t hav

e be

en fo

llow

ed.

The fi e

lds

are

also

insp

ecte

d af

ter

the

tria

ls, i

n or

der

to p

reve

nt a

ny p

ossi

ble

gene

tran

sfer

fr

om tr

ansg

enic

vol

unte

er p

lant

s or

har

vest

res

idue

s to

oth

er o

rgan

ism

s. F

or fi

eld

tria

ls u

nder

fl e

xibi

lizac

ión

CO

NA

BIA

will

onl

y re

com

men

d th

at in

spec

tions

be

mad

e at

har

vest

and

of

the

mea

sure

s ta

ken

for

the fi n

al d

ispo

sitio

n of

the

mat

eria

l.

• A

t the

end

of t

he p

erio

d fo

r w

hich

the

auth

oris

atio

n w

as g

rant

ed, t

he a

pplic

ant m

ust s

ubm

it to

C

ON

AB

IA a

fi na

l rep

ort.

CO

NA

BIA

will

not

eva

luat

e an

y fu

rthe

r ap

plic

atio

n fr

om a

pub

lic o

r pr

ivat

e in

stitu

tion

whi

ch h

ad fa

iled

to p

rese

nt a

fi na

l rep

ort.

Appendix 8

212

Statutory Review of the Gene Technology Act 2000

Pena

lties

•

Not

kno

wn

at th

is s

tage

.

Liab

ility

for

cont

amin

atio

n•

Th

ere

is n

o m

entio

n of

liab

ility

for

cont

amin

atio

n.

Polic

y an

d G

over

nanc

e is

sues

Expe

rt c

omm

ittee

s•

CO

NA

BIA

is a

mul

tidis

cipl

inar

y an

d in

ter-

inst

itutio

nal g

roup

who

se m

embe

rs a

re

repr

esen

tativ

es o

f the

pub

lic a

nd p

rivat

e se

ctor

s w

orki

ng in

Agr

icul

tura

l Bio

tech

nolo

gy.

Res

earc

h•

CO

NA

BIA

req

uest

s th

at a

pplic

ants

per

form

res

earc

h bu

t doe

s no

t con

duct

the

rese

arch

.

Oth

er

The

prec

autio

nary

pr

inci

ple

• T

he w

hole

dep

artm

ent o

pera

tes

unde

r th

e 19

92 R

io D

ecla

ratio

n on

Env

iron

men

t and

D

evel

opm

ent v

ersi

on o

f the

pre

caut

iona

ry p

rinc

iple

.

Cos

t rec

over

y•

Not

app

licab

le.

Prot

ectio

n of

con

fi den

tial

com

mer

cial

info

rmat

ion

• P

arts

of a

pplic

atio

ns th

at c

onta

in tr

ade

secr

ets

or c

onfi d

entia

l inf

orm

atio

n ar

e pr

otec

ted.

• T

here

is n

o da

ta e

xclu

sivi

ty.

Mor

ator

ium

• N

ot a

pplic

able

.

Oth

er

213

and the Gene Technology Agreement

RE

GU

LA

TIO

N O

F G

EN

E T

EC

HN

OL

OG

Y I

N C

HIN

A

SUM

MA

RY —

The

Min

istr

y of

Agr

icul

ture

app

ears

to b

e m

ainl

y re

spon

sibl

e fo

r th

e fo

rmul

atio

n an

d im

plem

enta

tion

of

regu

latio

ns in

rel

atio

n to

bio

tech

nolo

gy a

nd b

iosa

fety

.

• O

ther

inte

rest

ed g

over

nmen

t age

ncie

s in

clud

e th

e St

ate

Envi

ronm

enta

l Pro

tect

ion

Age

ncy,

the

Min

istr

y of

Pub

lic H

ealth

, th

e In

spec

tion

and

Qua

rant

ine

Age

ncy,

the

Min

istr

y of

For

eign

Eco

nom

y an

d Tr

ade

and

the

Min

istr

y of

Sci

ence

s an

d Te

chno

logi

es.

• A

ll th

ese

agen

cies

’ vie

ws

are

repr

esen

ted

on S

tate

Min

iste

rial

Cou

ncil.

• D

ay-t

o-da

y re

gula

tion

of G

MO

s is

adm

inis

tere

d by

the

Offi

ce o

f Agr

icul

tura

l Gen

etic

Eng

inee

ring

Bio

safe

ty A

dmin

istr

atio

n.

How

ever

, in

late

200

5, th

e C

hine

se G

over

nmen

t for

med

a n

ew b

ody

to a

dmin

iste

r G

MO

reg

ulat

ion.

• T

he M

inis

try

of P

ublic

Hea

lth is

res

pons

ible

for

food

saf

ety

in r

elat

ion

to G

MO

s in

tend

ed fo

r th

at p

urpo

se.

• T

he M

inis

try

for

Scie

nces

and

Tec

hnol

ogie

s is

res

pons

ible

for

biot

echn

olog

y re

sear

ch.

• G

enet

ic e

ngin

eeri

ng w

ork

is c

lass

ifi ed

into

four

cla

sses

of r

isk

to h

uman

hea

lth a

nd e

colo

gica

l env

iron

men

t: n

one;

low

; in

term

edia

te; a

nd h

igh.

• T

he r

isk

clas

sifi c

atio

n is

det

erm

ined

by

the

rele

vant

age

ncie

s on

the

Stat

e M

inis

teri

al C

ounc

il.

Con

tain

ed w

ork

wit

h G

MO

s

Res

pons

ible

age

ncy

• T

his

may

dep

end

on th

e cl

assifi e

d le

vel o

f ris

k fo

r th

e ty

pe o

f wor

k be

ing

done

, but

gen

eral

ly n

o or

lo

w r

isk,

con

tain

ed e

xper

imen

tal w

ork

wou

ld n

orm

ally

req

uire

app

rova

l fro

m th

e ad

min

istr

atio

n of

the

inst

itutio

n in

whi

ch th

e w

ork

is c

ondu

cted

. H

owev

er, h

ighe

r ri

sk w

ork

requ

ires

add

ition

al

appr

oval

from

the

rele

vant

dep

artm

ents

und

er th

e St

ate

Cou

ncil

and

the

Nat

iona

l Gen

etic

En

gine

erin

g Sa

fety

Com

mitt

ee.

Legi

slat

ion

• S

afet

y A

dmin

istr

atio

n an

d R

egul

atio

n on

Gen

etic

Eng

inee

ring

Reg

ulat

ions

(199

3).

Appendix 8

214

Statutory Review of the Gene Technology Act 2000

Ass

essm

ent p

roce

ss

for

cont

aine

d w

ork

invo

lvin

g G

MO

s

• I

nstit

utio

ns c

arry

ing

out g

enet

ic e

xper

imen

tal r

esea

rch

shou

ld c

ondu

ct e

valu

atio

n on

DN

A d

onor

s,

vect

ors,

hos

ts a

nd g

enet

ic e

ngin

eere

d or

gani

sms.

Fac

tors

con

side

red

shou

ld in

clud

e pa

thog

enic

ity,

carc

inog

enic

ity, c

hem

ical

res

ista

nce,

tran

sfer

pos

sibi

lity,

and

effe

cts

on e

nvir

onm

ent o

f tar

get g

enes

, ve

ctor

s, h

osts

and

gen

etic

ally

eng

inee

red

orga

nism

s, a

nd o

n de

term

inin

g bi

olog

ical

con

trol

and

ph

ysic

al c

ontr

ol c

lass

es.

• F

or in

term

edia

te r

isk

wor

k, th

e in

stitu

tion’

s ad

min

istr

atio

n sh

ould

con

side

r th

e ap

plic

atio

n an

d th

en

subm

it th

e ap

plic

atio

n to

the

rele

vant

dep

artm

ents

und

er th

e St

ate

Cou

ncil

for

cons

ider

atio

n. F

or

high

ris

k w

ork,

the

appl

icat

ion

is s

ubm

itted

to th

e N

atio

nal G

enet

ic E

ngin

eeri

ng S

afet

y C

omm

ittee

fo

r ap

prov

al a

fter

bein

g su

bmitt

ed to

the

rele

vant

dep

artm

ent u

nder

the

Stat

e C

ounc

il.

• I

nstit

utio

ns c

arry

ing

out g

enet

ic e

ngin

eeri

ng w

ork

shou

ld g

o th

roug

h th

e fo

llow

ing

appl

icat

ion

proc

edur

es:

the

chie

f of t

he p

lann

ed g

enet

ic e

ngin

eeri

ng p

roje

ct s

houl

d ev

alua

te th

e sa

fety

of t

he

proj

ect a

nd fi

ll in

the

appl

icat

ion

form

; the

aca

dem

ic c

omm

ittee

of t

he in

stitu

tion

shou

ld c

ondu

ct

tech

nica

l eva

luat

ion

on th

e ap

plic

atio

n; a

pplic

atio

ns s

houl

d be

sub

mitt

ed a

long

with

tech

nica

l do

cum

enta

tion.

• S

afet

y m

easu

res

incl

ude:

dev

elop

men

t of s

afet

y co

ntro

l mea

sure

s ap

prop

riat

e fo

r th

e cl

ass

of r

isk;

w

aste

man

agem

ent p

roce

dure

s (G

MO

s sh

ould

be

kille

d an

d di

spos

ed o

f to

prev

ent d

isse

min

atio

n an

d en

viro

nmen

tal p

ollu

tion)

; dev

elop

men

t of m

easu

res

to p

reve

nt a

ccid

ents

; app

ropr

iate

sto

rage

an

d tr

ansp

orta

tion

prov

isio

ns; m

aint

aini

ng a

wri

tten

safe

ty c

ontr

ol r

ecor

d fo

r a

min

imum

of t

en

year

s; r

equi

rem

ent f

or in

stitu

tions

taki

ng im

med

iate

mea

sure

s to

res

tric

t and

alle

viat

e ha

rm if

it is

di

scov

ered

that

the

inst

itutio

n’s

wor

k is

cau

sing

env

iron

men

tal d

amag

e or

har

m.

Con

side

ratio

n of

et

hica

l iss

ues

• T

here

was

no

spec

ifi c

requ

irem

ent f

or e

thic

al is

sues

to b

e co

nsid

ered

.

Publ

ic c

onsu

ltatio

n on

app

licat

ions

• T

here

was

no

spec

ifi c

men

tion

for

the

requ

irem

ent f

or p

ublic

con

sulta

tion.

215

and the Gene Technology Agreement

Con

ditio

ns th

at m

ay

be a

pplie

d•

No

spec

ifi c

men

tion

of th

e co

nditi

ons

to b

e ap

plie

d w

ere

men

tione

d, b

ut r

elev

ant a

dmin

istr

ativ

e de

part

men

ts w

ill is

sue

war

ning

s, s

top

oper

atio

n, s

uspe

nd fi

nanc

ial s

uppo

rt, c

onfi s

cate

ille

gal p

rofi t

s ac

cord

ing

to a

ctua

l con

ditio

ns o

f vio

latio

ns.

Mon

itori

ng,

surv

eilla

nce

and

enfo

rcem

ent p

ower

s

• L

aws

and

regu

latio

ns in

trod

uced

in 2

002

and

2003

con

tain

pro

visi

ons

for

mon

itori

ng a

nd

surv

eilla

nce

to e

nsur

e en

viro

nmen

tal s

afet

y fr

om u

se o

f GM

Os.

Pena

lties

• R

elev

ant a

dmin

istr

ativ

e de

part

men

ts w

ill is

sue

war

ning

s, s

top

oper

atio

n, s

uspe

nd fi

nanc

ial s

uppo

rt,

confi

sca

te il

lega

l profi t

s ac

cord

ing

to a

ctua

l con

ditio

ns o

f vio

latio

n w

hen:

the

gen

etic

eng

inee

ring

pr

ojec

t beg

ins

oper

atio

n w

ithou

t app

rova

l; eq

uipm

ent,

appa

ratu

s, la

bora

tori

es w

hich

do

not fi

t in

w

ith r

egul

atio

ns h

ave

been

use

d; v

iola

tion

of s

afet

y op

erat

ion

regu

latio

ns o

f gen

etic

eng

inee

ring

w

ork

has

occu

rred

; vio

latio

n of

oth

er r

ules

und

er th

e re

gula

tions

occ

ur.

• B

oth

indi

vidu

als

and

the

inst

itutio

n co

nduc

ting

the

wor

k ca

n be

liab

le fo

r an

y da

mag

es r

esul

ting

from

the

wor

k.

• R

espo

nsib

le in

stitu

tions

of t

hose

vio

latin

g an

y re

leva

nt le

gisl

atio

n an

d ca

usin

g on

e of

the

follo

win

g re

sults

mus

t im

med

iate

ly s

top

the

viol

atio

n an

d ta

ke m

easu

res

to h

andl

e th

e po

llutio

n an

d co

mpe

nsat

e fo

r lo

sses

: ca

usin

g se

riou

s en

viro

nmen

t pol

lutio

n; c

ausi

ng d

amag

e or

har

m to

the

publ

ic h

ealth

; cau

sing

sev

ere

dam

age

to e

colo

gica

l res

ourc

es a

nd e

colo

gica

l bal

ance

. C

rim

inal

ch

arge

s ca

n al

so b

e la

id s

ubje

ct to

the

appr

opri

ate

legi

slat

ion.

Inte

ntio

nal r

elea

ses

of G

MO

s in

the

env

iron

men

t

Res

pons

ible

age

ncy

• D

epar

tmen

ts u

nder

the

Stat

e C

ounc

il; D

epar

tmen

t of A

gric

ultu

re; D

epar

tmen

t of S

cien

ce a

nd

Tech

nolo

gy; S

tate

Env

iron

men

tal P

rote

ctio

n A

dmin

istr

atio

n; N

atio

nal G

enet

ic E

ngin

eeri

ng

Safe

ty C

omm

ittee

.

Appendix 8

216

Statutory Review of the Gene Technology Act 2000

Legi

slat

ion

• S

afet

y A

dmin

istr

atio

n an

d R

egul

atio

n on

Gen

etic

Eng

inee

ring

Reg

ulat

ions

(199

3).

• R

egul

atio

ns o

n A

dmin

istr

atio

n of

Agr

icul

tura

l GM

Os

Safe

ty (2

001)

.

Cov

erag

e of

the

legi

slat

ion

Ass

essm

ent p

roce

ss

for

inte

ntio

nal

rele

ases

of a

G

MO

into

the

envi

ronm

ent (fi e

ld

tria

ls a

nd g

ener

al

rele

ases

)

• I

nstit

utio

ns c

arry

ing

out g

enet

ic e

ngin

eeri

ng p

ilot e

xper

imen

ts o

r in

dust

rial

pro

duct

ion

shou

ld

cond

uct s

afet

y ev

alua

tion

on th

e ph

ysic

al b

arri

ers

of th

e eq

uipm

ent a

nd fa

cilit

ies

of th

e cu

lture

, fe

rmen

tatio

n, s

epar

atio

n an

d pu

rifi c

atio

n pr

oces

ses

acco

rdin

g to

gen

etic

eng

inee

red

orga

nism

s sa

fety

cla

ss, t

o de

term

ine

the

safe

ty c

lass

of p

ilot e

xper

imen

ts o

r in

dust

rial

pro

duct

ion.

• I

nstit

utio

ns c

arry

ing

out t

he re

leas

e of

gen

etic

eng

inee

red

orga

nism

s sh

ould

con

duct

eva

luat

ion

on th

e sa

fety

of g

enet

ic e

ngin

eere

d or

gani

sms,

the

purp

ose

of th

e re

leas

e, e

colo

gica

l env

ironm

ent c

ondi

tions

of

the

rele

ase

site

, rel

easi

ng m

etho

ds, m

onito

ring

mea

ns a

nd c

ontro

l mea

sure

s, to

det

erm

ine

the

safe

ty c

lass

of t

he re

leas

e. A

ppro

val f

or w

ork

clas

sifi e

d as

no

risk

shou

ld b

e ob

tain

ed fr

om th

e ch

ief

adm

inis

trato

rs o

f the

inst

itutio

n; a

ppro

val f

or w

ork

clas

sifi e

d as

low

risk

requ

ires

appr

oval

by

rele

vant

St

ate

Cou

ncil

depa

rtmen

ts; i

nter

med

iate

risk

wor

k al

so re

quire

s ap

prov

al fr

om re

leva

nt S

tate

Cou

ncil

depa

rtmen

ts w

ith th

e ap

plic

atio

n re

cord

ed b

y th

e N

atio

nal G

enet

ic E

ngin

eerin

g Sa

fety

Com

mitt

ee;

appl

icat

ions

for h

igh

risk

wor

k is

exa

min

ed b

y th

e re

leva

nt S

tate

Cou

ncil

depa

rtmen

ts a

nd s

ubm

itted

fo

r app

rova

l to

the

Nat

iona

l Gen

etic

Eng

inee

ring

Safe

ty C

omm

ittee

.

• I

nstit

utio

ns c

arry

ing

out g

enet

ic e

ngin

eeri

ng w

ork

shou

ld g

o th

roug

h th

e fo

llow

ing

appl

icat

ion

proc

edur

es:

the

chie

f of t

he p

lann

ed g

enet

ic e

ngin

eeri

ng p

roje

ct s

houl

d ev

alua

te th

e sa

fety

of

the

proj

ect a

nd fi

ll in

the

appl

icat

ion

form

; the

aca

dem

ic c

omm

ittee

of t

he in

stitu

tion

shou

ld

cond

uct t

echn

ical

eva

luat

ion

on th

e ap

plic

atio

n; a

pplic

atio

ns s

houl

d be

sub

mitt

ed a

long

with

te

chni

cal d

ocum

enta

tion.

217

and the Gene Technology Agreement

Ass

essm

ent p

roce

ss

for

inte

ntio

nal

rele

ases

of a

G

MO

into

the

envi

ronm

ent (fi e

ld

tria

ls a

nd g

ener

al

rele

ases

) (co

ntin

ued)

• S

afet

y m

easu

res

incl

ude:

dev

elop

men

t of s

afet

y co

ntro

l mea

sure

s ap

prop

riat

e fo

r th

e cl

ass

of r

isk;

w

aste

man

agem

ent p

roce

dure

s (G

MO

s sh

ould

be

kille

d an

d di

spos

ed o

f to

prev

ent d

isse

min

atio

n an

d en

viro

nmen

tal p

ollu

tion)

; dev

elop

men

t of m

easu

res

to p

reve

nt a

ccid

ents

; app

ropr

iate

sto

rage

an

d tr

ansp

orta

tion

prov

isio

ns; m

aint

aini

ng a

wri

tten

safe

ty c

ontr

ol r

ecor

d fo

r a

min

imum

of t

en

year

s; r

equi

rem

ent f

or in

stitu

tions

taki

ng im

med

iate

mea

sure

s to

res

tric

t and

alle

viat

e ha

rm if

it is

di

scov

ered

that

the

inst

itutio

n’s

wor

k is

cau

sing

env

iron

men

tal d

amag

e or

har

m.

Con

side

ratio

n of

et

hica

l iss

ues

• T

here

was

no

spec

ifi c

requ

irem

ent f

or e

thic

al is

sues

to b

e co

nsid

ered

.

Publ

ic c

onsu

ltatio

n on

app

licat

ions

• T

here

was

no

spec

ifi c

men

tion

for

the

requ

irem

ent f

or p

ublic

con

sulta

tion.

Con

ditio

ns th

at m

ay

be a

pplie

d•

No

spec

ifi c

men

tion

of th

e co

nditi

ons

to b

e ap

plie

d w

ere

men

tione

d, b

ut r

elev

ant a

dmin

istr

ativ

e de

part

men

ts w

ill is

sue

war

ning

s, s

top

oper

atio

n, s

uspe

nd fi

nanc

ial s

uppo

rt, c

onfi s

cate

ille

gal p

rofi t

s ac

cord

ing

to a

ctua

l con

ditio

ns o

f vio

latio

ns.

Mon

itori

ng,

surv

eilla

nce

and

enfo

rcem

ent p

ower

s

• L

aws

and

regu

latio

ns in

trod

uced

in 2

002

and

2003

con

tain

pro

visi

ons

for

mon

itori

ng a

nd

surv

eilla

nce

to e

nsur

e en

viro

nmen

tal s

afet

y fr

om u

se o

f GM

Os.

Appendix 8

218

Statutory Review of the Gene Technology Act 2000

Pena

lties

• R

elev

ant a

dmin

istr

ativ

e de

part

men

ts w

ill is

sue

war

ning

s, s

top

oper

atio

n, s

uspe

nd fi

nanc

ial s

uppo

rt,

confi

sca

te il

lega

l profi t

s ac

cord

ing

to a

ctua

l con

ditio

ns o

f vio

latio

n w

hen:

the

gene

tic e

ngin

eeri

ng

proj

ect b

egin

s op

erat

ion

with

out a

ppro

val;

equi

pmen

t, ap

para

tus,

labo

rato

ries

whi

ch d

o no

t fi t

in

with

reg

ulat

ions

hav

e be

en u

sed;

vio

latio

n of

saf

ety

oper

atio

n re

gula

tions

of g

enet

ic e

ngin

eeri

ng

wor

k ha

s oc

curr

ed; v

iola

tion

of o

ther

rul

es u

nder

the

regu

latio

ns o

ccur

.

• B

oth

indi

vidu

als

and

the

inst

itutio

n co

nduc

ting

the

wor

k ca

n be

liab

le fo

r an

y da

mag

es r

esul

ting

from

the

wor

k.

• R

espo

nsib

le in

stitu

tions

of t

hose

vio

latin

g an

y re

leva

nt le

gisl

atio

n an

d ca

usin

g on

e of

the

follo

win

g re

sults

mus

t im

med

iate

ly s

top

the

viol

atio

n an

d ta

ke m

easu

res

to h

andl

e th

e po

llutio

n an

d co

mpe

nsat

e fo

r lo

sses

: ca

usin

g se

riou

s en

viro

nmen

t pol

lutio

n; c

ausi

ng d

amag

e or

har

m to

the

publ

ic h

ealth

; cau

sing

sev

ere

dam

age

to e

colo

gica

l res

ourc

es a

nd e

colo

gica

l bal

ance

. C

rim

inal

ch

arge

s ca

n al

so b

e la

id s

ubje

ct to

the

appr

opri

ate

legi

slat

ion.

Ass

essm

ent

proc

ess

for

inte

ntio

nal r

elea

ses

of a

GM

O fo

r co

mm

erci

alis

atio

n

• U

se o

f fi n

ishe

d ge

netic

eng

inee

ring

pro

duct

s (in

tend

ed fo

r re

leas

e) s

houl

d be

acc

ompa

nied

by

biol

ogic

al te

sts

for

the

purp

oses

of a

saf

ety

eval

uatio

n, w

hich

will

det

erm

ine

the

poss

ible

impa

ct o

f th

e pr

oduc

t on

the

publ

ic h

ealth

and

the

ecol

ogic

al e

nvir

onm

ent.

• F

or w

ork

clas

sifi e

d be

twee

n no

ris

k an

d in

term

edia

te r

isk,

app

licat

ions

sho

uld

be s

ubm

itted

to th

e re

leva

nt d

epar

tmen

ts u

nder

the

Stat

e C

ounc

il fo

r ap

prov

al a

nd to

the

Nat

iona

l Gen

etic

Eng

inee

ring

Sa

fety

Com

mitt

ee fo

r th

eir

reco

rd.

• F

or r

elea

ses

clas

sifi e

d as

hig

h ri

sk, t

he a

pplic

atio

n sh

ould

be

exam

ined

by

the

rele

vant

de

part

men

ts u

nder

the

Stat

e C

ounc

il an

d su

bmitt

ed to

the

Nat

iona

l Gen

etic

Eng

inee

ring

Saf

ety

Com

mitt

ee fo

r ap

prov

al.

219

and the Gene Technology Agreement

Ass

essm

ent

proc

ess

for

inte

ntio

nal r

elea

ses

of a

GM

O fo

r co

mm

erci

alis

atio

n

• In

stitu

tions

car

ryin

g ou

t gen

etic

eng

inee

ring

wor

k sh

ould

go

thro

ugh

the

follo

win

g ap

plic

atio

n pr

oced

ures

: th

e ch

ief o

f the

pla

nned

gen

etic

eng

inee

ring

proj

ect s

houl

d ev

alua

te th

e sa

fety

of t

he p

roje

ct

and fi l

l in

the

appl

icat

ion

form

; the

aca

dem

ic c

omm

ittee

of t

he in

stitu

tion

shou

ld c

ondu

ct te

chni

cal

eval

uatio

n on

the

appl

icat

ion;

app

licat

ions

sho

uld

be s

ubm

itted

alo

ng w

ith te

chni

cal d

ocum

enta

tion.

• S

afet

y m

easu

res

incl

ude:

dev

elop

men

t of s

afet

y co

ntro

l mea

sure

s ap

prop

riat

e fo

r th

e cl

ass

of r

isk;

w

aste

man

agem

ent p

roce

dure

s (G

MO

s sh

ould

be

kille

d an

d di

spos

ed o

f to

prev

ent d

isse

min

atio

n an

d en

viro

nmen

tal p

ollu

tion)

; dev

elop

men

t of m

easu

res

to p

reve

nt a

ccid

ents

; app

ropr

iate

sto

rage

an

d tr

ansp

orta

tion

prov

isio

ns; m

aint

aini

ng a

wri

tten

safe

ty c

ontr

ol r

ecor

d fo

r a

min

imum

of t

en

year

s; r

equi

rem

ent f

or in

stitu

tions

taki

ng im

med

iate

mea

sure

s to

res

tric

t and

alle

viat

e ha

rm if

it is

di

scov

ered

that

the

inst

itutio

n’s

wor

k is

cau

sing

env

iron

men

tal d

amag

e or

har

m.

Con

side

ratio

n of

et

hica

l iss

ues

• T

here

was

no

spec

ifi c

requ

irem

ent f

or e

thic

al is

sues

to b

e co

nsid

ered

.

Publ

ic c

onsu

ltatio

n on

app

licat

ions

• T

here

was

no

spec

ifi c

men

tion

for

the

requ

irem

ent f

or p

ublic

con

sulta

tion.

Con

ditio

ns th

at m

ay

be a

pplie

d•

No

spec

ifi c

men

tion

of th

e co

nditi

ons

to b

e ap

plie

d w

ere

men

tione

d, b

ut r

elev

ant a

dmin

istr

ativ

e de

part

men

ts w

ill is

sue

war

ning

s, s

top

oper

atio

n, s

uspe

nd fi

nanc

ial s

uppo

rt, c

onfi s

cate

ille

gal p

rofi t

s ac

cord

ing

to a

ctua

l con

ditio

ns o

f vio

latio

ns.

Mon

itori

ng,

surv

eilla

nce

and

enfo

rcem

ent p

ower

s

• L

aws

and

regu

latio

ns in

trod

uced

in 2

002

and

2003

con

tain

pro

visi

ons

for

mon

itori

ng a

nd

surv

eilla

nce

to e

nsur

e en

viro

nmen

tal s

afet

y fr

om u

se o

f GM

Os.

220

Statutory Review of the Gene Technology Act 2000

Pena

lties

• R

elev

ant a

dmin

istr

ativ

e de

part

men

ts w

ill is

sue

war

ning

s, s

top

oper

atio

n, s

uspe

nd fi

nanc

ial s

uppo

rt,

confi

sca

te il

lega

l profi t

s ac

cord

ing

to a

ctua

l con

ditio

ns o

f vio

latio

n w

hen:

the

gen

etic

eng

inee

ring

pr

ojec

t beg

ins

oper

atio

n w

ithou

t app

rova

l; eq

uipm

ent,

appa

ratu

s, la

bora

tori

es w

hich

do

not fi

t in

w

ith r

egul

atio

ns h

ave

been

use

d; v

iola

tion

of s

afet

y op

erat

ion

regu

latio

ns o

f gen

etic

eng

inee

ring

w

ork

has

occu

rred

; vio

latio

n of

oth

er r

ules

und

er th

e re

gula

tions

occ

ur.

• B

oth

indi

vidu

als

and

the

inst

itutio

n co

nduc

ting

the

wor

k ca

n be

liab

le fo

r an

y da

mag

es r

esul

ting

from

the

wor

k.

• I

nstit

utio

ns r

espo

nsib

le fo

r vi

olat

ing

any

rele

vant

legi

slat

ion

and

caus

ing

one

of th

e fo

llow

ing

resu

lts

mus

t im

med

iate

ly s

top

the

viol

atio

n an

d ta

ke m

easu

res

to h

andl

e th

e po

llutio

n an

d co

mpe

nsat

e fo

r lo

sses

: ca

usin

g se

riou

s en

viro

nmen

t pol

lutio

n; c

ausi

ng d

amag

e or

har

m to

the

publ

ic h

ealth

; ca

usin

g se

vere

dam

age

to e

colo

gica

l res

ourc

es a

nd e

colo

gica

l bal

ance

. C

rim

inal

cha

rges

can

als

o be

laid

sub

ject

to th

e ap

prop

riat

e le

gisl

atio

n.

Polic

y an

d G

over

nanc

e is

sues

Liab

ility

for

cont

amin

atio

n•

Ins

titut

ions

are

res

pons

ible

for

any

clea

n-up

req

uire

men

ts a

nd p

rovi

ding

com

pens

atio

n fo

r lo

sses

.

• C

rim

inal

cha

rges

can

als

o be

laid

sub

ject

to th

e ap

prop

riat

e le

gisl

atio

n.

Expe

rt c

omm

ittee

s•

Nat

iona

l Gen

etic

Eng

inee

ring

Saf

ety

Com

mitt

ee.

• N

atio

nal A

gric

ultu

ral G

MO

Bio

safe

ty C

omm

ittee

par

ticip

ates

in b

iosa

fety

man

agem

ent.

Res

earc

h•

At t

he n

atio

nal l

evel

, the

Min

istr

y of

Agr

icul

ture

, the

Chi

nese

Aca

dem

y of

Sci

ence

s, th

e St

ate

Fore

stry

Bur

eau

and

the

Min

istr

y of

Edu

catio

n ar

e th

e m

ajor

aut

hori

ties

resp

onsi

ble

for

agri

cultu

ral

biot

echn

olog

y re

sear

ch.

• U

nder

the

Min

istr

y of

Agr

icul

ture

, the

re a

re th

ree

larg

e ac

adem

ies:

the

Chi

nese

Aca

dem

y of

A

gric

ultu

ral S

cien

ces;

the

Chi

nese

Aca

dem

y of

Tro

pica

l Agr

icul

ture

; and

the

Chi

nese

Aca

dem

y of

Fi

sher

ies.

221

and the Gene Technology Agreement

Oth

er

The

prec

autio

nary

pr

inci

ple

• N

o sp

ecifi

c m

entio

n of

the

prec

autio

nary

pri

ncip

le w

as fo

und

in a

ny o

f the

info

rmat

ion

foun

d on

th

e C

hine

se g

ene

tech

nolo

gy r

egul

atio

n re

gim

e.

Cos

t rec

over

y•

Ins

titut

ions

who

se w

ork

with

GM

Os

has

caus

ed e

nvir

onm

enta

l dam

age

are

resp

onsi

ble

for

taki

ng

rem

edia

l act

ion

and

for

com

pens

atio

n co

sts.

Prot

ectio

n of

co

nfi d

entia

l co

mm

erci

al

info

rmat

ion

N

o re

fere

nce

was

foun

d to

this

.

Mor

ator

ium

N

o sp

ecifi

c m

entio

n of

a m

orat

oriu

m w

as fo

und;

how

ever

, Chi

na in

trod

uced

mor

e re

stri

ctiv

e bi

osaf

ety

regu

latio

ns in

200

2.

Oth

er•

Chi

na h

as r

atifi

ed th

e C

arte

gena

pro

toco

l on

bios

afet

y.

• A

s of

200

3, C

hina

was

in th

e pr

oces

s of

intr

oduc

ing

new

/upd

atin

g ex

istin

g la

ws

and

regu

latio

ns

gove

rnin

g w

ork

invo

lvin

g G

MO

s. T

he in

form

atio

n in

this

tabl

e m

ay s

oon

be s

uper

sede

d.

• G

M la

belli

ng g

uide

lines

took

effe

ct fr

om 2

002.

• I

nfor

mat

ion

was

sou

rced

from

http

://w

ww

.ebn

ic.o

rg (h

ttp://

ww

w.e

bnic

.org

/det

ails

c.ht

m#h

apte

r%20

Tw

o:%

20Sa

fety

%20

Cla

sses

%20

and%

20Sa

fety

%20

Eval

uatio

n) a

nd h

ttp://

ww

w.c

hina

.org

.cn/

engl

ish.

In

stitu

te o

f Dev

elop

men

tal S

tudi

es w

orki

ng p

aper

195

, Jik

un H

uang

and

Qin

fang

Wan

g,

Bio

tech

nolo

gy p

olic

y an

d re

gula

tion

in C

hina

(200

3).

Appendix 8