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Biosafety

and the environment

An introduction to
the Cartagena Protocol
on Biosafety
This introduction to the Cartagena Protocol on Biosafety was published in June 2003
by the Secretariat of the Convention on Biological Diversity and the United Nations
Environment Programme to assist public understanding of the Cartagena Protocol on
Biosafety. It is not intended to provide legal interpretation of the Protocol. Please
refer to the original text of the Protocol for any further information. Permission is
granted to reproduce or translate the contents giving appropriate credit. For more
information or additional copies, please contact:

The Secretariat of the Convention on Biological Diversity


393 St. Jacques, Suite 300
Montreal, Quebec, Canada H2Y 1N9
secretariat@biodiv.org
www.biodiv.org

United Nations Environment Programme


DEC/Information Unit for Conventions
International Environment House, Geneva
11-13, chemin des Anémones
CH-1219, Châtelaine, Switzerland
iuc@unep.ch
www.unep.org

GE.03-01836/E

Printed in France on recycled paper


Biosafety
and the environment
An Introduction to the Cartagena Protocol on Biosafety
THE BIOSAFETY PROTOCOL WILL ENABLE PEOPLE EVERYWHERE
TO ENJOY THE BENEFITS OF BIOTECHNOLOGY WHILE
AVOIDING UNNECESSARY RISKS.

Contents

The Convention on Biological Diversity and its 3


Cartagena Protocol on Biosafety

1. Introduction: the biotech revolution 4


2. Biosafety and precaution 6
3. The Biosafety Protocol in action 8
4. The Cartagena Protocol and other 12
international agreements

5. Conclusion: a role for everybody 14

2
The Convention on Biological Diversity
and its Cartagena Protocol on Biosafety

Governments and civil society are collaborating through the Convention on


Biological Diversity to reverse the tide of devastation that humanity has in-
flicted upon the natural world. The stakes are high: although some 40% of the
world economy is derived directly from biological diversity, humanity is pushing
ecosystems, species and gene pools to extinction faster than at any time since
the dinosaurs died out 65 million years ago.
At present, natural habitats and ecosystems are being destroyed at the rate
of over 100 million hectares every year. More than 31,000 plant and animal
species are threatened with extinction; according to the Food and Agriculture
Organization of the UN, at least one breed of livestock dies out every week.
Band-aids are not enough: only a fundamental and far-reaching solution can
ensure a biologically rich world for future generations.
Adopted in 1992 under the auspices of the United Nations Environment
Programme, the Convention is the first global treaty to provide a comprehen-
sive framework that addresses all aspects of biodiversity – ecosystems, spe-
cies, and genetic diversity. It also introduces a new strategy for the biodiversity
crisis known as the “ecosystem approach”, which aims to reconcile the need
for environmental conservation with concern for economic development. By
promoting “sustainable development”, the Convention seeks to ensure that
the earth’s renewable resources are not consumed so intensively that they
cannot replenish themselves.
Now boasting almost 190 member governments (known as “Parties”), the
Convention has three goals: the conservation of biodiversity, the sustainable
use of the components of biodiversity, and the fair and equitable sharing of
the benefits arising from the use of genetic resources.
When crafting the Convention, governments recognized that modern bio-
technology has the potential to contribute to achieving these three goals – as
long as it is developed and used with adequate safety measures for the envi-
ronment and human health. These governments put this conviction into ac-
tion a few years later by establishing the Cartagena Protocol within the frame-
work of the Convention.

3
1 Introduction:
the biotech revolution
Genetic manipulation is not new. For value, higher yield, improved nutri-
millennia, farmers have relied on tion, or resistance to pests and dis-
selective breeding and cross-fertili- ease. Proponents argue that biotech-
zation to modify plants and animals nology will boost food security for
and encourage desirable traits that the world’s growing population by
improve food production and satisfy raising sustainable food production.
other human needs. Artisans have It will benefit the environment by
exploited traditional fermentation reducing the need for more farm-
techniques to transform grains into land, irrigation and pesticides. It will
bread and beer and milk into cheese. also provide better medical treat-
Such intentional modification of the ments and vaccines, new industrial
natural world has contributed enor- products and improved fibres and
mously to human well-being. fuels.
Over the past 30 years, however, For many people, however, this
our ability to alter life-forms has been rapidly advancing science raises a
revolutionized by modern biotech- tangle of ethical, environmental, so-
nology. Scientists have learned how cial and health issues. Because mod-
to extract and transfer strands of DNA ern biotechnology is still so new, they
and entire genes – which contain the say, much is unknown about how its
biochemical instructions governing products may behave and evolve,
how an organism will develop – from and how they may interact with
one species to other species.
another. Using Could an ability
sophisticated While modern to tolerate her-
techniques, they biotechnology may have bicides, for ex-
can precisely great potential, it must be ample, transfer
manipulate the developed and used with from GM crops
intricate genetic adequate safety measures, to related wild
structure of indi- particularly for the species? Might
vidual living plants that have
environment.
cells. For exam- been geneti-
ple, they can in- cally modified
sert genes from a coldwater fish into to repel pests also harm beneficial
a tomato to create a frost-resistant insects? Could the increased com-
plant, or use bacterial genes to make petitiveness of a GMO cause it to
herbicide-tolerant corn. The results damage biologically-rich ecosys-
are known as living modified organ- tems?
isms (LMOs) or, more popularly, Such concerns have kept GMOs
genetically modified organisms in the headlines. One new scientific
(GMOs). study concludes that modified organ-
Since the first genetically modified isms pose little risk – and then an-
tomato became available in shops in other raises difficult new questions.
the United States in 1994, dozens of Modified soya is found in export
food crops and animals have been shipments that had been declared
modified for greater commercial GMO free, or pollen from modified

4
corn is detected in a nearby non-
modified field. Editors fret about po-
tential trade conflicts, and commen-
tators recite emotional arguments
about the pros and cons of modern
biotechnology.
Fortunately, this debate has led
to a broad consensus that, while
modern biotechnology may have
great potential, it must be developed
and used with adequate safety meas-
ures, particularly for the environ-
ment. Countries with strong biotech-
nology industries do have national
legislation and risk-assessment
systems in place. However, many
developing countries interested in
modern biotechnology and its prod-
ucts are still in the process of draft-
ing regulations. And because bio-
technology is a global industry, and
GMOs are traded across borders,
international rules are needed as USING SOPHISTICATED TECHNIQUES, SCIENTISTS CAN PRECISELY MANIPULATE THE
well. INTRICATE GENETIC STRUCTURE OF INDIVIDUAL LIVING CELLS.

In 1995, the Parties to the Con-


vention on Biological Diversity re-
sponded to this challenge by launch-
ing negotiations on a legally bind-
ing agreement that would address
potential risks posed by GMOs.
These discussions culminated in
January 2000 with the adoption of
the Cartagena Protocol on Biosafety.
To promote biosafety, the Protocol reflects a
Named after the Colombian city fundamental concept known as the
where the final round of talks was precautionary approach.
launched, the Protocol for the first
time sets out a comprehensive regu-
latory system for ensuring the safe
transfer, handling and use of GMOs
subject to transboundary movement.
In this way, the Protocol seeks to
meet the needs of consumers, indus-
try and the environment for many
decades to come. This booklet ex-
plains how this system works.

5
Biosafety and precaution
2
Before turning to how the Protocol international agreements and organi-
operates in practice, we must first zations or products derived from
examine two key underlying GMOs, such as cooking oil from ge-
concepts, namely: biosafety and netically modified corn or paper
precaution. from GM trees.
The concept of biosafety encom- To promote biosafety, the Protocol
passes a range of measures, policies reflects another fundamental
and procedures for minimizing po- concept known as the precautionary
tential risks that biotechnology may approach. It reaffirms Principle 15 of
pose to the environment and human the 1992 Rio Declaration on
health. Establishing credible and ef- Environment and Development,
fective safeguards for GMOs is criti- which states that, “where there are
cal for maximizing the benefits of threats of serious or irreversible
biotechnology while minimizing its damage, lack of full scientific
risks. Such safeguards must be put certainty shall not be used as a
in place now, while biotechnology reason for postponing cost-effective
is still relatively young. measures to prevent environmental
Biosafety is currently being pro- degradation”.
moted in a variety of ways by indus- Other international agreements
try, governments and civil society. also apply the precautionary
The particular contribution of the approach to their particular concern.
Cartagena Protocol to global In the case of the Biosafety Protocol,
biosafety is helping to ensure: this concept means that a
government may decide on the basis
“an adequate level of protection of precaution not to permit a
in the field of the safe transfer, particular GMO to be imported
handling and use of living modi- across its borders. This is the case
fied organisms resulting from even if there is insufficient scientific
modern biotechnology that may evidence about the GMO’s potential
have adverse effects on the con- adverse effects.
servation and sustainable use of The Protocol applies precaution
biological diversity, taking also not just to biodiversity, but to
into account risks to human potential risks to human health as
health, and specifically focusing well. It also gives importing countries
on transboundary movements”. the right to take into account socio-
economic concerns (provided their
The Protocol deals primarily with actions are “consistent with their
GMOs that are to be intentionally international obligations”). Such
introduced into the environment concerns could include the risk that
(such as seeds, trees or fish) and with imports of genetically engineered
genetically modified farm commodi- foods may replace traditional crops,
ties (such as corn and grain used for undermine local cultures and
food, animal feed or processing). traditions or reduce the value
It does not cover pharmaceuticals of biodiversity to indigenous
for humans addressed by other communities.

6
UNCERTAINTIES ABOUT THE EFFECTS OF GMOS ON WILD SPECIES, INCLUDING POLLINATORS SUCH AS BUTTERFLIES AND
HONEYBEES, HAS LED TO INCREASED SUPPORT FOR THE PRECAUTIONARY APPROACH.

The Protocol aims to “contribute to ensuring an adequate level of


protection in the field of the safe transfer, handling and use of living
modified organisms … ”

7
The Biosafety Protocol
3 in action
The Cartagena Protocol promotes An Advance Informed Agree-
biosafety by establishing practical ment procedure. The most
rules and procedures for the safe rigorous procedures are re-
transfer, handling and use of GMOs, served for GMOs that are to be in-
with a specific focus on regulating troduced intentionally into the envi-
movements of these organisms ronment. These include seeds, live
across borders, from one country to fish and other organisms that are
another. destined to grow and that have the
This system features two separate potential to pass their modified genes
sets of procedures, one for GMOs on to succeeding generations.
that are to be intentionally intro- The exporter starts by giving the
duced into the environment, and one government of the importing coun-
for GMOs that are to be used directly try detailed written information, in-
as food or feed or for processing. cluding a description of the organ-
Both sets of procedures are designed ism, in advance of the shipment. A
to ensure that recipient countries are Competent National Authority in the
provided with the information they importing country acknowledges re-
need for making informed decisions ceipt of this information within 90
about whether or not to accept GMO days and then explicitly authorizes
imports. Governments exchange this the shipment within 270 days or
information through a Biosafety states its reasons for rejecting it – al-
Clearing-House and base their deci- though the absence of a response is
sions on scientifically sound risk as- not to be interpreted as implying
sessments and on the precautionary consent.
approach. In this way, the Advance Informed
When a country decides to allow Agreement procedure ensures that
the import of a GMO, the exporter recipient countries have the oppor-
must ensure that all shipments are tunity to assess any risks that may be
accompanied by appropriate docu- associated with a GMO before
mentation. Governments must also agreeing to its import.
adopt measures for managing any The AIA procedure applies only
risks identified by risk assessments, to the first intentional transboundary
and they must continue to monitor movement of any particular GMO
and control any risks that may intended for introduction into the
emerge in the future. This applies to environment. It does not apply to
traded as well as domestically pro- GMOs in transit through a country,
duced GMOs. GMOs destined for contained use (in
To ensure its own long-term effec- a scientific laboratory for example)
tiveness, the Protocol also contains or GMOs to be directly used as food
a number of “enabling” provisions, or animal feed or for processing
including capacity-building, public (such as corn or tomatoes). However,
awareness and participation and a a country may, under its domestic
financial mechanism. regulatory framework, and consis-
These various elements all merit tent with the objective of the Proto-
a closer look: col, decide to subject such GMOs

8
THE MOST RIGOROUS BIOSAFETY RULES AND PROCEDURES ARE RESERVED FOR GMOS THAT ARE TO BE INTRODUCED INTENTIONALLY
INTO THE ENVIRONMENT.

to risk assessment and other require- cedure for such commodities, the
ments. Protocol establishes a simpler sys-
In the future, the Parties to the Pro- tem. Under this system, governments
tocol may also decide to exempt that approve these commodities for
additional GMOs from the AIA pro- domestic use have to communicate
cedure. this decision to the world commu-
nity via the Biosafety Clearing-
A simplified system for agri- House. They must also provide de-
cultural commodities. The tailed information about their deci-
largest category of GMOs in sion. In addition, countries may take
international trade is bulk shipments decisions on whether or not to im-
containing genetically modified port these commodities on the basis
corn, soybeans and other agricultural of their domestic law and must then
commodities intended for direct use declare these decisions through the
as food or feed or for processing and Clearing-House.
not as seeds for growing new crops. In this way, the Protocol seeks to
Instead of requiring the use of the limit the extra costs involved for
Advance Informed Agreement pro- commodity producers and traders

9
while ensuring that the international other affected or potentially affected
trading system is transparent. governments when it becomes
aware that GMOs under its jurisdic-
Risk assessments. The Proto- tion may cross international borders
col empowers governments due to illegal trade or release into
to decide whether or not to the environment. This will enable
accept imports of GMOs on the ba- them to pursue emergency measures
sis of risk assessments. These assess- or other appropriate action. Gov-
ments aim to identify and evaluate ernments must establish official
the potential adverse effects that a contact points for emergencies as
GMO may have on the conservation a way of improving international
and sustainable use of biodiversity coordination.
in the receiving environments. They
are to be undertaken in a scientific Export documentation. For
manner using recognized risk- GMOs intended for direct in-
assessment techniques. troduction into the environ-
While the country considering ment, the accompanying documen-
permitting the import of a GMO is tation must clearly state that the ship-
responsible for ensuring that a risk ment contains GMOs. It must specify
assessment is carried out, it has the the identity and relevant traits and
right to require the exporter to do the characteristics of the GMO; any re-
work or to bear the cost. This is par- quirements for its safe handling, stor-
ticularly important for many devel- age, transport and use; a contact
oping countries. point for further information; and the
names and addresses of the importer
Risk management and emer- and exporter. The documentation
gency procedures. No tech- must also declare that the shipment
nology or human activity is conforms to the Cartagena Protocol.
completely risk-free. People accept In cases where a government
new technologies because they be- agrees to import a genetically modi-
fied commodity intended for direct
use as food or feed or for process-
The Biosafety Clearing-House facilitates ing, the shipment must clearly indi-
transparency and the sharing of information, cate that it “may contain” living
which are vital to a dynamic and effective modified organisms and that these
global biosafety system. organisms are not intended for intro-
duction into the environment.

lieve the potential benefits outweigh The Biosafety Clearing-


the potential risks. The Protocol re- House (BCH). The Biosafety
quires each country to manage and Clearing-House is one of the
control any risks that may be identi- cornerstones of the Protocol’s
fied by a risk assessment. Key ele- biosafety regime. It facilitates trans-
ments of effective risk management parency and the sharing of informa-
include monitoring systems, research tion, which are vital to a dynamic
programmes, technical training and and effective global biosafety system.
improved domestic coordination In addition to enabling governments
amongst government agencies and to inform others about their final de-
services. cisions regarding the import of
The Protocol also requires each GMOs, the Biosafety Clearing-
government to notify and consult House contains information on

10
national laws, regulations, and guide-
lines for implementing the Protocol.
The Biosafety Clearing-House
also includes information required
under the AIA procedure, summaries
of risk assessments and environmen-
tal reviews, bilateral and multilateral
agreements, reports on efforts to im-
plement the Protocol, plus other sci-
entific, legal, environmental and
technical information. Common for-
mats are used to ensure that the in-
formation collected from different
countries is comparable.
The Biosafety Clearing-House has
been developed largely as an
Internet-based system and can be
found at http://bch.biodiv.org.

Capacity-building and THE PROTOCOL CALLS FOR THE SAFE TRANSFER, HANDLING AND USE OF GMOS
AND SPECIFICALLY HIGHLIGHTS THE NEED FOR PUBLIC AWARENESS AND
finance. Countries that trade EDUCATION.
in GMOs need to have the ca-
pacity to implement the Protocol.
They need skills, equipment, regu- the global environment. Govern-
latory frameworks and procedures to ments are also expected to promote
enable them to assess the risks, make private-sector involvement in
informed decisions, and manage or building capacity.
avoid any potential adverse effects
of GMOs on their natural relatives. Public awareness and partici-
Those governments that do not al- pation. It is clearly important
ready have a domestic regulatory that individual citizens under-
system for biosafety need to develop stand and are involved in national
one – the sooner the better. decisions on GMOs. The Protocol
The Protocol therefore actively therefore calls for cooperation on
promotes international cooperation promoting public awareness of the
to help developing countries and safe transfer, handling and use of
countries with economies in transi- GMOs. It specifically highlights the
tion build the human resources and need for education, which will in-
institutions needed for biosafety. It creasingly have to address GMOs as
also encourages governments to as- biotechnology becomes more and
sist others with scientific and tech- more a part of our lives.
nical training, to promote the trans- The Protocol also calls for the
fer of technology and know-how and public to be actively consulted on
to provide financial resources to GMOs and biosafety. Individuals,
those countries. communities and non-governmental
Biosafety activities under the organizations should remain fully
Cartagena Protocol are eligible engaged in this complex issue. This
for support from the Global will enable people to contribute to
Environment Facility – an inter- the final decisions taken by govern-
national fund that was established to ments, thus promoting transparency
help developing countries protect and informed decision-making.

11
The Cartagena Protocol and
4 other international agreements
Although the Cartagena Protocol on The World Organization for
Biosafety is the only international Animal Health (OIE), which
instrument that deals exclusively develops standards and
with GMOs, it does not exist in a guidelines designed to prevent the
vacuum. The Convention on Biologi- introduction of infectious agents and
cal Diversity, the “parent” of the Pro- diseases into the importing country
tocol, itself requires governments to during international trade in animals,
take measures to regulate, manage animal genetic material and animal
or control the risks associated with products. The OIE Standards
the use and release of GMOs. There Commission published, in 2000, the
are also a number of separate inter- Manual of Standards for Diagnostic
national instruments and standard- Tests and Vaccines. Some of the tests
setting processes that address vari- and vaccines described are gen-
ous aspects of biosafety. etically engineered. Likewise, the
These include: OIE working group on bio-
technology has produced several
The International Plant Pro- technical publications relating to
tection Convention (IPPC), animal production and risk analysis.
which protects plant health However, it has not as yet ap-
by assessing and managing the risks proved international standards on
of plant pests. The IPPC is in the biotechnology.
process of setting standards to ad-
dress the plant pest risks associated Biosafety considerations are also
with GMOs and invasive species. covered in codes of practice on the
Any GMO that could be considered use of introduced species and
a plant pest falls within the scope of GMOs adopted by some Regional
this treaty. The IPPC allows govern- Fisheries bodies of the Food and
ments to take action to prevent the Agricultural Organization of the
introduction and spread of such United Nations.
pests. It also establishes procedures
for analysing pest risks, including A number of World Trade
impacts on natural vegetation. Organization (WTO) agree-
ments, such as the Agreement
The Codex Alimentarius on the Application of Sanitary and
Commission, which ad- Phytosanitary Measures and the
dresses food safety and con- Technical Barriers to Trade Agree-
sumer health. The Commission has ment, contain provisions that are rel-
established an ad hoc Intergovern- evant to biosafety.
mental Task Force on Foods Derived The drafters of the Cartagena Pro-
from Biotechnologies that is respon- tocol made every effort to ensure that
sible for developing standards and its provisions and the trade agree-
guidelines for genetically modified ments are mutually supportive. The
foods. The Commission is also con- Protocol states that its provisions are
sidering the issue of labeling biotech intended neither to override nor to
foods to allow the consumer to make be subordinate to existing interna-
an informed choice. tional agreements.

12
THE CARTAGENA PROTOCOL IS COMPLEMENTED BY SEVERAL OTHER INTERNATIONAL INSTRUMENTS AND STANDARD-SETTING
PROCESSES THAT ADDRESS ASPECTS OF BIOSAFETY SUCH AS FOOD SAFETY AND CONSUMER HEALTH.

These various agreements on


biosafety, trade, agriculture, and re-
lated topics are all intended to func- Improving the coordination among the various
tion together and to be mutually international regimes can greatly strengthen
complementary. However, avoiding biosafety while reconciling the legitimate
potential conflicts often requires
interests of trade, biosafety and other sectors.
good will and careful management.
Improving the coordination among
the various international regimes can
greatly strengthen biosafety while
avoiding potential conflicts and rec-
onciling the legitimate interests of
trade, biosafety and other sectors.

13
5 Conclusion:
a role for everybody
The Cartagena Protocol can only world around us. It is already chang-
ensure that the global use of biotech- ing agriculture and what many of us
nology is safe if each and every eat. Any major mistakes could lead
country actively promotes biosafety to tragic and perhaps permanent
at the national level. changes in the natural world. For
National policymakers and legis- these reasons, future generations are
lators have a vital role to play in es- likely to look back to our time and
tablishing and strengthening laws either thank us or curse us for what
and standards for reducing the po- we do – or don’t do – about GMOs
tential risks of GMOs. Under the Pro- and biosafety.
tocol, it is governments that are ulti- Doing the right thing is not sim-
mately responsible for preventing il- ple. Our efforts today are compli-
legal shipments and accidental re- cated by the wide array of
leases, managing any risks or emer- stakeholders and countries engaged
gencies and regulating national in the issue. The people involved in
biotech industries. biosafety often have widely differing
But governments cannot achieve values and expectations. Only a con-
biosafety on their own: they need the tinuing debate that is transparent, re-
active involvement and cooperation spectful and vigorous can ensure that
of other stakeholders, in particular all points of view are reflected in the
agricultural and final outcome.
health-care re- Given the
search institutes complexities and
and the biotech- the high stakes, it
Governments cannot
nology industry. is reassuring that
achieve biosafety on
Biotech re- the global com-
searchers and their own: they need munity has al-
companies have the active involvement ready agreed on a
the expertise, the and cooperation of the regulatory safe-
resources and other stakeholders. guard at this early
the incentive for stage in the de-
keeping biotech- velopment of
nology and its modern biotech-
products safe and beneficial. As for nology. Of course, the science con-
civil society, individual citizens and tinues to advance rapidly. To ensure
non-governmental organizations that the biosafety regime keeps pace,
need to understand the issues and governments will formally review the
make their views clear to both effectiveness of the Protocol and its
policymakers and industry. The me- procedures every five years – with
dia have a vital watchdog role to an eye to revising and improving the
play. agreement if required.
Because biotechnology is such a There can be no doubt that
revolutionary science, and has biosafety will remain at the top of
spawned such a powerful industry, the international environmental
it has great potential to reshape the agenda for many years to come.

14
BIOTECHNOLOGY HAS GREAT POTENTIAL TO RESHAPE THE WORLD AROUND US AND IS ALREADY CHANGING AGRICULTURE AND
WHAT MANY OF US EAT.

Biotechnology could contribute significantly to the achievement


of the objectives of the Convention on Biological Diversity and
the attainment of the Millennium Development Goals. However,
it must be developed judiciously, and used with adequate and
transparent safety measures.

– United Nations Secretary-General Kofi Annan

15
Additional publications on the Convention on Biological Diversity and
the Cartagena Protocol on Biosafety may be obtained from:

The Secretariat of the Convention on Biological Diversity


World Trade Centre
393 St. Jacques Street, Suite 300
Montreal, Quebec, Canada H2Y 1N9
Phone: + 1 (514) 288 2220; Fax: + 1 (514) 288 6588
E-mail: secretariat@biodiv.org
Website: http://www.biodiv.org

16
Photo credits: cover, top to bottom: UNEP/KB Hemalatha;
FAO/S. Hood; UNEP/Bert Wiklund; UNEP/Orjan Furubjelke.
Page 1: UNEP/John Bauernfeind; 2: UNEP/Thakur Paramjit;
4/5: FAO/S. Hood; 6/7: UNEP/KB Hemalatha;
8/9: UNEP/ Shemesh Avraham; 10/11: UNEP/
Duan xing-yun; 12/13: UNEP/Orjan Furubjelke;
14/15: UNEP/Jose Armand Maksim; 16: CBD;
inside back cover: UNEP/Hiroyoshi Ohhama;
back cover: CBD
www.biodiv.org/biosafety/

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