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An Introduction to CPB

and Importance of BCH

to CPB Obligations

Biosafety

and

the Environment


What is

Biosafety?


Biosafety:


Efforts to reduce or

eliminate potential risks

resulting from modern
biotechnology and its products



What is

Biotechnology?


Bio:



Life

Technology:

Any technique


to produce new


products or


processes

Biotechnology

Biotechnology:


Any technological application

that uses biological systems,

living organisms, or

derivatives thereof,

to make or modify products

or process for a specific use



Modern

Biotechnology (CPB,
Art.3(i)a)

the application of:


in vitro

nucleic acid techniques,


including recombinant DNA and


direct injection of nucleic acid


into cells or organelles, or....


Modern

Biotechnology (CPB,
Art.3(i)b)

the application of:


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taxonomic family,

that overcome natural physiological
barriers and that are not techniques
used in traditional breeding and selection


Why is Biosafety

an Environmental
issue?


Agenda 21, Rio Declaration on

Environment and Development



Comprehensive action plan to


be taken in every area in


which humans impact on the


environment



Adopted at UNCED, 1992







Chapter 16 of Agenda 21,

“Environmentally Sound
Management of Biotechnology”

addresses biotechnology in

5 programme areas








Chapter 16 of Agenda 21,

2 of 5, biosafety
-
relevant areas:



Enhancing protection of the


environment



Establishing enabling mechanisms


for development & application


of environmentally sound


biotechnology








Agenda 21, Rio Declaration on

Environment and Development




Action plan for 21
st

century



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䑩癥牳楴礠⡃䉄⤠慮搠潴桥牳







Convention on Biological Diversity



Adopted under auspices of


UNEP (1992, Rio)



First global treaty to provide


a comprehensive framework


that addresses all aspects


of biodiversity



188 ‘Parties’ to date



3 Goals of CBD:




Conservation of biodiversity



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of biodiversity



Fair and equitable sharing of


benefits arising from the use of


genetic resources


CBD Goals and Biotech:


Governments recognized that
modern

biotechnology has the

potential to contribute to

achieving these 3 goals…




CBD Goals and Biotech:


…as long as it is developed

and used with adequate

safety measures for the

environment and

human health.






Agenda 21/CBD (Rio 1992)

COP 2 (Jakarta 1995)

CPB (Montreal 2000)

CPB in force (2003)

COP2 1995:


Negotiations for a legally
binding agreement on
genetically modified

organisms (GMOs)



Cartagena Protocol on
Biosafety (CPB)

Negotiations concluded on 29
Jan. 2000 (Montreal) with
adoption of the Cartagena

Protocol on Biosafety within
the framework of the
Convention




Key Concepts of CPB
:



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摥捩獩潮d䥉⼵


䍏倲
)



灲散慵瑩潮p(
偲楮捩灬攠ㄵ


Rio Declaration
)



Objective of CPB (Art. 1)

To contribute to ensuring an
adequate level of protection in the
field of
safe transfer, handling and
use of living modified organisms

resulting from modern biotechnology
......





Objective of CPB (Art.1)

.... that may have
adverse effects

on the
conservation

and
sustainable
use of biological diversity
, taking
into account
risks to human health
,
and specifically focusing on
transboundary movements
.





Scope of CPB (Art. 4)

… shall apply to the transboundary
movement, transit, handling and use
of all living modified organisms that
may have an adverse effect on the
conservation and sustainable use of
biological diversity, taking also into
account risks to human health



Biosafety

CPB
deals

primarily with

L
MOs
that are to be intentionally
introduced into the environment

or used for food, feed or
further processing (LMOs
-
FFP)
(Arts.7 & 11)



Biosafety and Precaution

To promote biosafety, the
Protocol reaffirms another
fundamental concept known
as the ‘
precautionary
approach





Precautionary Approach (Principle 15
of 1992 Rio Declaration on
Environment and Development)

...”where there are threats of serious
or irreversible damage, lack of full
scientific certainty shall not be used as
a reason for postponing cost
-
effective
measures to prevent environmental
degradation”.

Biosafety and Precaution

... This is the case even if there
is insufficient scientific evidence
about the GMO’s potential
adverse effects.
(Art. 10.6))




Biosafety and Precaution

Governments may decide on basis
of precaution not to permit a
particular GMO to be imported
across its borders....



Precaution & LMOs for FFP
(Art.11.8)


Lack of scientific certainty due to
insufficient relevant information…

shall not prevent that Party from
taking a decision….with regard to
import of that LMO
-
FFP….



The Protocol (CPB)
applies

precaution not just to
potential risks to biodiversity,
but also to human health.




Key Elements for Operation of CPB



Advance Informed Agreement


(AIA) procedure
(Art.7)



Special procedure for


agricultural commodities
(Art.11)



RA, RM & ERP
(Arts. 15 & 16,


Annex III)



BCH
(Art.20)


Advance Informed Agreement (Art.7)




Applies to
first

intentional


transboundary movement of LMO


for intentional introduction into


the environment of the Party of


import



Advance Informed Agreement (Art.7)




Not applicable to TB movement of:




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⡁牴⸵(

††


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⡁牴⸶(




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effects
(Art.7.4)


Advance Informed Agreement

(Art.7)



Intentional introduction to the

environment not applicable to:




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⡁牴⸷⸲(

††



LMOs for FFP (Art.11)


A party that makes a final decision
regarding domestic use including
placing on the market,… LMOs for
FFP shall,
within 15 days
of making
that decision,
inform the Parties,
thru the BCH….

(Art.11.1)



LMOs for FFP (Art.11.5)


Each party shall
make available to
the BCH copies

of any
national laws,
regulations and guidelines

applicable
to the import of LMOs intended for
FFP
, if available.



LMOs for FFP (Art.11.6)


… in the absence of domestic regulatory
framework and in exercise of its

domestic jurisdiction, declare
to

the BCH its decision,
prior to the first
import of LMO
-
FFP, will be taken
according to:




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BCH and Simplified Procedure
(Art.13)


A party of import …. specify in

advance
to the BCH:



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楳潴楦楥搠



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Decision making and Timeframes




Party of import shall acknowledge


receipt of notification…


within
90 days
(Arts.9.1)



Party of import shall communicate


decision to the
BCH

and the notifier


within
270 days

of notification


(Art. 10.3)


Socio
-
economics and Decision
making (Art.26)

Gives importing countries the

right to take into account socio
-
economic concerns in making a
decision on the import (provided
they are “consistent with their
international obligations”).




Socio
-
economic Considerations
(Art. 26)

...
Such concerns could include the
risk that GM foods may replace
traditional crops, undermine local
cultures and traditions or reduce
the value of biodiversity to
indigenous communities.






RA
-

Potential areas of concern
about GMO release (Arts.15&16)



adverse effects on non
-
target


species (e.g. beneficial insects)


and ecosystems



potential for weediness, more


invasive & possible gene transfer


to wild relatives



stability of inserted gene



Governments cannot achieve
biosafety on their own: they need
the active involvement & cooperation
of other stakeholders:



Policymakers & legislators



Biotech. researchers & companies



Civil society



Media



What is UNEP
-
GEF’s

role in biotechnology

and biosafety?


UNEP
-
GEF Projects

for National Biosafety
Frameworks


Up to 130 country
Projects on
Development

of NBF


8 country
Demonstration
Projects on
Implementation

of NBF

BCH

Project (139)

+

Review Questions


What is biosafety and What is
modern
biotechnology?


What is the CBD and what are its 3
Goals?


What are the Key Concepts of CPB?


What is the Objective of the CPB?


What is the Scope of CPB?


What are the Key Elements for
Operation of the CPB?

THANK YOU

www.unep.ch/biosafety