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Biosafetyand the environment

An introduction tothe Cartagena Protocol

on Biosafety

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

The Secretariat of the Convention on Biological Diversity393 St. Jacques, Suite 300Montreal, Quebec, Canada H2Y [email protected]

United Nations Environment ProgrammeDEC/Information Unit for ConventionsInternational Environment House, Geneva11-13, chemin des AnémonesCH-1219, Châtelaine, [email protected]

GE.03-01836/E

Printed in France on recycled paper

Biosafetyand the environment

An Introduction to the Cartagena Protocol on Biosafety

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Contents

The Convention on Biological Diversity and its 3Cartagena 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 12international agreements

5. Conclusion: a role for everybody 14

THE BIOSAFETY PROTOCOL WILL ENABLE PEOPLE EVERYWHERETO ENJOY THE BENEFITS OF BIOTECHNOLOGY WHILEAVOIDING UNNECESSARY RISKS.

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Governments and civil society are collaborating through the Convention onBiological Diversity to reverse the tide of devastation that humanity has in-flicted upon the natural world. The stakes are high: although some 40% of theworld economy is derived directly from biological diversity, humanity is pushingecosystems, species and gene pools to extinction faster than at any time sincethe dinosaurs died out 65 million years ago.

At present, natural habitats and ecosystems are being destroyed at the rateof over 100 million hectares every year. More than 31,000 plant and animalspecies are threatened with extinction; according to the Food and AgricultureOrganization 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 canensure a biologically rich world for future generations.

Adopted in 1992 under the auspices of the United Nations EnvironmentProgramme, 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 biodiversitycrisis known as the “ecosystem approach”, which aims to reconcile the needfor environmental conservation with concern for economic development. Bypromoting “sustainable development”, the Convention seeks to ensure thatthe earth’s renewable resources are not consumed so intensively that theycannot replenish themselves.

Now boasting almost 190 member governments (known as “Parties”), theConvention has three goals: the conservation of biodiversity, the sustainableuse of the components of biodiversity, and the fair and equitable sharing ofthe 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 – aslong 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.

The Convention on Biological Diversityand its Cartagena Protocol on Biosafety

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Genetic manipulation is not new. Formillennia, farmers have relied onselective breeding and cross-fertili-zation to modify plants and animalsand encourage desirable traits thatimprove food production and satisfyother human needs. Artisans haveexploited traditional fermentationtechniques to transform grains intobread and beer and milk into cheese.Such intentional modification of thenatural world has contributed enor-mously to human well-being.

Over the past 30 years, however,our ability to alter life-forms has beenrevolutionized by modern biotech-nology. Scientists have learned howto extract and transfer strands of DNAand entire genes – which contain thebiochemical instructions governinghow an organism will develop – fromone species toanother. Usingsophi s t i ca tedtechniques, theycan preciselymanipulate theintricate geneticstructure of indi-vidual livingcells. For exam-ple, they can in-sert genes from a coldwater fish intoa tomato to create a frost-resistantplant, or use bacterial genes to makeherbicide-tolerant corn. The resultsare known as living modified organ-isms (LMOs) or, more popularly,genetically modified organisms(GMOs).

Since the first genetically modifiedtomato became available in shops inthe United States in 1994, dozens offood crops and animals have beenmodified for greater commercial

Introduction:the biotech revolution1

While modernbiotechnology may have

great potential, it must bedeveloped and used withadequate safety measures,

particularly for theenvironment.

value, higher yield, improved nutri-tion, or resistance to pests and dis-ease. Proponents argue that biotech-nology will boost food security forthe world’s growing population byraising sustainable food production.It will benefit the environment byreducing the need for more farm-land, irrigation and pesticides. It willalso provide better medical treat-ments and vaccines, new industrialproducts and improved fibres andfuels.

For many people, however, thisrapidly advancing science raises atangle of ethical, environmental, so-cial and health issues. Because mod-ern biotechnology is still so new, theysay, much is unknown about how itsproducts may behave and evolve,and how they may interact with

other species.Could an abilityto tolerate her-bicides, for ex-ample, transferfrom GM cropsto related wildspecies? Mightplants that havebeen geneti-cally modified

to repel pests also harm beneficialinsects? Could the increased com-petitiveness of a GMO cause it todamage biologically-rich ecosys-tems?

Such concerns have kept GMOsin the headlines. One new scientificstudy concludes that modified organ-isms pose little risk – and then an-other raises difficult new questions.Modified soya is found in exportshipments that had been declaredGMO free, or pollen from modified

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corn is detected in a nearby non-modified field. Editors fret about po-tential trade conflicts, and commen-tators recite emotional argumentsabout the pros and cons of modernbiotechnology.

Fortunately, this debate has ledto a broad consensus that, whilemodern biotechnology may havegreat potential, it must be developedand used with adequate safety meas-ures, particularly for the environ-ment. Countries with strong biotech-nology industries do have nationallegislation and risk-assessmentsystems in place. However, manydeveloping countries interested inmodern biotechnology and its prod-ucts are still in the process of draft-ing regulations. And because bio-technology is a global industry, andGMOs are traded across borders,international rules are needed aswell.

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 addresspotential risks posed by GMOs.These discussions culminated inJanuary 2000 with the adoption ofthe Cartagena Protocol on Biosafety.Named after the Colombian citywhere the final round of talks waslaunched, the Protocol for the firsttime sets out a comprehensive regu-latory system for ensuring the safetransfer, handling and use of GMOssubject to transboundary movement.In this way, the Protocol seeks tomeet the needs of consumers, indus-try and the environment for manydecades to come. This booklet ex-plains how this system works.

USING SOPHISTICATED TECHNIQUES, SCIENTISTS CAN PRECISELY MANIPULATE THEINTRICATE GENETIC STRUCTURE OF INDIVIDUAL LIVING CELLS.

To promote biosafety, the Protocol reflects afundamental concept known as theprecautionary approach.

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Before turning to how the Protocoloperates in practice, we must firstexamine two key underlyingconcepts, namely: biosafety andprecaution.

The concept of biosafety encom-passes a range of measures, policiesand procedures for minimizing po-tential risks that biotechnology maypose to the environment and humanhealth. Establishing credible and ef-fective safeguards for GMOs is criti-cal for maximizing the benefits ofbiotechnology while minimizing itsrisks. Such safeguards must be putin place now, while biotechnologyis still relatively young.

Biosafety is currently being pro-moted in a variety of ways by indus-try, governments and civil society.The particular contribution of theCartagena Protocol to globalbiosafety is helping to ensure:

“an adequate level of protectionin the field of the safe transfer,handling and use of living modi-fied organisms resulting frommodern biotechnology that mayhave adverse effects on the con-servation and sustainable use ofbiological diversity, taking alsointo account risks to humanhealth, and specifically focusingon transboundary movements”.

The Protocol deals primarily withGMOs that are to be intentionallyintroduced into the environment(such as seeds, trees or fish) and withgenetically modified farm commodi-ties (such as corn and grain used forfood, animal feed or processing).It does not cover pharmaceuticalsfor humans addressed by other

Biosafety and precaution

international agreements and organi-zations or products derived fromGMOs, such as cooking oil from ge-netically modified corn or paperfrom GM trees.

To promote biosafety, the Protocolreflects another fundamentalconcept known as the precautionaryapproach. It reaffirms Principle 15 ofthe 1992 Rio Declaration onEnvironment and Development,which states that, “where there arethreats of serious or irreversibledamage, lack of full scientificcertainty shall not be used as areason for postponing cost-effectivemeasures to prevent environmentaldegradation”.

Other international agreementsalso apply the precautionaryapproach to their particular concern.In the case of the Biosafety Protocol,this concept means that agovernment may decide on the basisof precaution not to permit aparticular GMO to be importedacross its borders. This is the caseeven if there is insufficient scientificevidence about the GMO’s potentialadverse effects.

The Protocol applies precautionnot just to biodiversity, but topotential risks to human health aswell. It also gives importing countriesthe right to take into account socio-economic concerns (provided theiractions are “consistent with theirinternational obligations”). Suchconcerns could include the risk thatimports of genetically engineeredfoods may replace traditional crops,undermine local cultures andtraditions or reduce the valueof biodiversity to indigenouscommunities.

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

The Protocol aims to “contribute to ensuring an adequate level ofprotection in the field of the safe transfer, handling and use of livingmodified organisms … ”

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The Biosafety Protocolin action

The Cartagena Protocol promotesbiosafety by establishing practicalrules and procedures for the safetransfer, handling and use of GMOs,with a specific focus on regulatingmovements of these organismsacross borders, from one country toanother.

This system features two separatesets of procedures, one for GMOsthat are to be intentionally intro-duced into the environment, and onefor GMOs that are to be used directlyas food or feed or for processing.Both sets of procedures are designedto ensure that recipient countries areprovided with the information theyneed for making informed decisionsabout whether or not to accept GMOimports. Governments exchange thisinformation through a BiosafetyClearing-House and base their deci-sions on scientifically sound risk as-sessments and on the precautionaryapproach.

When a country decides to allowthe import of a GMO, the exportermust ensure that all shipments areaccompanied by appropriate docu-mentation. Governments must alsoadopt measures for managing anyrisks identified by risk assessments,and they must continue to monitorand control any risks that mayemerge in the future. This applies totraded as well as domestically pro-duced GMOs.

To ensure its own long-term effec-tiveness, the Protocol also containsa number of “enabling” provisions,including capacity-building, publicawareness and participation and afinancial mechanism.

These various elements all merita closer look:

An Advance Informed Agree-ment procedure. The mostrigorous procedures are re-

served for GMOs that are to be in-troduced intentionally into the envi-ronment. These include seeds, livefish and other organisms that aredestined to grow and that have thepotential to pass their modified geneson to succeeding generations.

The exporter starts by giving thegovernment of the importing coun-try detailed written information, in-cluding a description of the organ-ism, in advance of the shipment. ACompetent National Authority in theimporting country acknowledges re-ceipt of this information within 90days and then explicitly authorizesthe shipment within 270 days orstates its reasons for rejecting it – al-though the absence of a response isnot to be interpreted as implyingconsent.

In this way, the Advance InformedAgreement procedure ensures thatrecipient countries have the oppor-tunity to assess any risks that may beassociated with a GMO beforeagreeing to its import.

The AIA procedure applies onlyto the first intentional transboundarymovement of any particular GMOintended for introduction into theenvironment. It does not apply toGMOs in transit through a country,GMOs destined for contained use (ina scientific laboratory for example)or GMOs to be directly used as foodor animal feed or for processing(such as corn or tomatoes). However,a country may, under its domesticregulatory framework, and consis-tent with the objective of the Proto-col, decide to subject such GMOs

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to risk assessment and other require-ments.

In the future, the Parties to the Pro-tocol may also decide to exemptadditional GMOs from the AIA pro-cedure.

A simplified system for agri-cultural commodities. Thelargest category of GMOs in

international trade is bulk shipmentscontaining genetically modifiedcorn, soybeans and other agriculturalcommodities intended for direct useas food or feed or for processing andnot as seeds for growing new crops.

Instead of requiring the use of theAdvance Informed Agreement pro-

cedure for such commodities, theProtocol establishes a simpler sys-tem. Under this system, governmentsthat approve these commodities fordomestic use have to communicatethis decision to the world commu-nity via the Biosafety Clearing-House. They must also provide de-tailed information about their deci-sion. In addition, countries may takedecisions on whether or not to im-port these commodities on the basisof their domestic law and must thendeclare these decisions through theClearing-House.

In this way, the Protocol seeks tolimit the extra costs involved forcommodity producers and traders

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

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while ensuring that the internationaltrading system is transparent.

Risk assessments. The Proto-col empowers governmentsto decide whether or not to

accept imports of GMOs on the ba-sis of risk assessments. These assess-ments aim to identify and evaluatethe potential adverse effects that aGMO may have on the conservationand sustainable use of biodiversityin the receiving environments. Theyare to be undertaken in a scientificmanner using recognized risk-assessment techniques.

While the country consideringpermitting the import of a GMO isresponsible for ensuring that a riskassessment is carried out, it has theright to require the exporter to do thework or to bear the cost. This is par-ticularly important for many devel-oping countries.

Risk management and emer-gency procedures. No tech-nology or human activity is

completely risk-free. People acceptnew technologies because they be-

lieve the potential benefits outweighthe potential risks. The Protocol re-quires each country to manage andcontrol any risks that may be identi-fied by a risk assessment. Key ele-ments of effective risk managementinclude monitoring systems, researchprogrammes, technical training andimproved domestic coordinationamongst government agencies andservices.

The Protocol also requires eachgovernment to notify and consult

other affected or potentially affectedgovernments when it becomesaware that GMOs under its jurisdic-tion may cross international bordersdue to illegal trade or release intothe environment. This will enablethem to pursue emergency measuresor other appropriate action. Gov-ernments must establish officialcontact points for emergencies asa way of improving internationalcoordination.

Export documentation. ForGMOs intended for direct in-troduction into the environ-

ment, the accompanying documen-tation must clearly state that the ship-ment contains GMOs. It must specifythe identity and relevant traits andcharacteristics of the GMO; any re-quirements for its safe handling, stor-age, transport and use; a contactpoint for further information; and thenames and addresses of the importerand exporter. The documentationmust also declare that the shipmentconforms to the Cartagena Protocol.

In cases where a governmentagrees to import a genetically modi-fied commodity intended for directuse as food or feed or for process-ing, the shipment must clearly indi-cate that it “may contain” livingmodified organisms and that theseorganisms are not intended for intro-duction into the environment.

The Biosafety Clearing-House (BCH). The BiosafetyClearing-House is one of the

cornerstones of the Protocol’sbiosafety regime. It facilitates trans-parency and the sharing of informa-tion, which are vital to a dynamicand effective global biosafety system.In addition to enabling governmentsto inform others about their final de-cisions regarding the import ofGMOs, the Biosafety Clearing-House contains information on

The Biosafety Clearing-House facilitatestransparency and the sharing of information,which are vital to a dynamic and effectiveglobal biosafety system.

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national laws, regulations, and guide-lines for implementing the Protocol.

The Biosafety Clearing-Housealso includes information requiredunder the AIA procedure, summariesof risk assessments and environmen-tal reviews, bilateral and multilateralagreements, reports on efforts to im-plement the Protocol, plus other sci-entific, legal, environmental andtechnical information. Common for-mats are used to ensure that the in-formation collected from differentcountries is comparable.

The Biosafety Clearing-House hasbeen developed largely as anInternet-based system and can befound at http://bch.biodiv.org.

Capacity-building andfinance. Countries that tradein GMOs need to have the ca-

pacity to implement the Protocol.They need skills, equipment, regu-latory frameworks and procedures toenable them to assess the risks, makeinformed decisions, and manage oravoid any potential adverse effectsof GMOs on their natural relatives.Those governments that do not al-ready have a domestic regulatorysystem for biosafety need to developone – the sooner the better.

The Protocol therefore activelypromotes international cooperationto help developing countries andcountries with economies in transi-tion build the human resources andinstitutions needed for biosafety. Italso encourages governments to as-sist others with scientific and tech-nical training, to promote the trans-fer of technology and know-how andto provide financial resources tothose countries.

Biosafety activities under theCartagena Protocol are eligiblefor support from the GlobalEnvironment Facility – an inter-national fund that was established tohelp developing countries protect

the global environment. Govern-ments are also expected to promoteprivate-sector involvement inbuilding capacity.

Public awareness and partici-pation. It is clearly importantthat individual citizens under-

stand and are involved in nationaldecisions on GMOs. The Protocoltherefore calls for cooperation onpromoting public awareness of thesafe transfer, handling and use ofGMOs. It specifically highlights theneed for education, which will in-creasingly have to address GMOs asbiotechnology becomes more andmore a part of our lives.

The Protocol also calls for thepublic to be actively consulted onGMOs and biosafety. Individuals,communities and non-governmentalorganizations should remain fullyengaged in this complex issue. Thiswill enable people to contribute tothe final decisions taken by govern-ments, thus promoting transparencyand informed decision-making.

THE PROTOCOL CALLS FOR THE SAFE TRANSFER, HANDLING AND USE OF GMOSAND SPECIFICALLY HIGHLIGHTS THE NEED FOR PUBLIC AWARENESS ANDEDUCATION.

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The Cartagena Protocol andother international agreements

Although the Cartagena Protocol onBiosafety is the only internationalinstrument that deals exclusivelywith GMOs, it does not exist in avacuum. The Convention on Biologi-cal Diversity, the “parent” of the Pro-tocol, itself requires governments totake measures to regulate, manageor control the risks associated withthe use and release of GMOs. Thereare also a number of separate inter-national instruments and standard-setting processes that address vari-ous aspects of biosafety.

These include:

The International Plant Pro-tection Convention (IPPC),which protects plant health

by assessing and managing the risksof plant pests. The IPPC is in theprocess of setting standards to ad-dress the plant pest risks associatedwith GMOs and invasive species.Any GMO that could be considereda plant pest falls within the scope ofthis treaty. The IPPC allows govern-ments to take action to prevent theintroduction and spread of suchpests. It also establishes proceduresfor analysing pest risks, includingimpacts on natural vegetation.

The Codex AlimentariusCommission , which ad-dresses food safety and con-

sumer health. The Commission hasestablished an ad hoc Intergovern-mental Task Force on Foods Derivedfrom Biotechnologies that is respon-sible for developing standards andguidelines for genetically modifiedfoods. The Commission is also con-sidering the issue of labeling biotechfoods to allow the consumer to makean informed choice.

The World Organization forAnimal Health (OIE), whichdevelops standards and

guidelines designed to prevent theintroduction of infectious agents anddiseases into the importing countryduring international trade in animals,animal genetic material and animalproducts. The OIE StandardsCommission published, in 2000, theManual of Standards for DiagnosticTests and Vaccines. Some of the testsand vaccines described are gen-etically engineered. Likewise, theOIE working group on bio-technology has produced severaltechnical publications relating toanimal production and risk analysis.However, it has not as yet ap-proved international standards onbiotechnology.

Biosafety considerations are alsocovered in codes of practice on theuse of introduced species andGMOs adopted by some RegionalFisheries bodies of the Food andAgricultural Organization of theUnited Nations.

A number of World TradeOrganization (WTO) agree-ments, such as the Agreement

on the Application of Sanitary andPhytosanitary Measures and theTechnical Barriers to Trade Agree-ment, contain provisions that are rel-evant to biosafety.

The drafters of the Cartagena Pro-tocol made every effort to ensure thatits provisions and the trade agree-ments are mutually supportive. TheProtocol states that its provisions areintended neither to override nor tobe subordinate to existing interna-tional agreements.

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These various agreements onbiosafety, trade, agriculture, and re-lated topics are all intended to func-tion together and to be mutuallycomplementary. However, avoidingpotential conflicts often requiresgood will and careful management.Improving the coordination amongthe various international regimes cangreatly strengthen biosafety whileavoiding potential conflicts and rec-onciling the legitimate interests oftrade, biosafety and other sectors.

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

Improving the coordination among the variousinternational regimes can greatly strengthenbiosafety while reconciling the legitimateinterests of trade, biosafety and other sectors.

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Conclusion:a role for everybody

The Cartagena Protocol can onlyensure that the global use of biotech-nology is safe if each and everycountry actively promotes biosafetyat the national level.

National policymakers and legis-lators have a vital role to play in es-tablishing and strengthening lawsand standards for reducing the po-tential risks of GMOs. Under the Pro-tocol, it is governments that are ulti-mately responsible for preventing il-legal shipments and accidental re-leases, managing any risks or emer-gencies and regulating nationalbiotech industries.

But governments cannot achievebiosafety on their own: they need theactive involvement and cooperationof other stakeholders, in particularagricultural andhealth-care re-search institutesand the biotech-nology industry.Biotech re-searchers andcompanies havethe expertise, theresources andthe incentive forkeeping biotech-nology and itsproducts safe and beneficial. As forcivil society, individual citizens andnon-governmental organizationsneed to understand the issues andmake their views clear to bothpolicymakers and industry. The me-dia have a vital watchdog role toplay.

Because biotechnology is such arevolutionary science, and hasspawned such a powerful industry,it has great potential to reshape the

world around us. It is already chang-ing agriculture and what many of useat. Any major mistakes could leadto tragic and perhaps permanentchanges in the natural world. Forthese reasons, future generations arelikely to look back to our time andeither thank us or curse us for whatwe do – or don’t do – about GMOsand biosafety.

Doing the right thing is not sim-ple. Our efforts today are compli-cated by the wide array ofstakeholders and countries engagedin the issue. The people involved inbiosafety often have widely differingvalues and expectations. Only a con-tinuing debate that is transparent, re-spectful and vigorous can ensure thatall points of view are reflected in the

final outcome. Given the

complexities andthe high stakes, itis reassuring thatthe global com-munity has al-ready agreed on aregulatory safe-guard at this earlystage in the de-velopment ofmodern biotech-

nology. Of course, the science con-tinues to advance rapidly. To ensurethat the biosafety regime keeps pace,governments will formally review theeffectiveness of the Protocol and itsprocedures every five years – withan eye to revising and improving theagreement if required.

There can be no doubt thatbiosafety will remain at the top ofthe international environmentalagenda for many years to come.

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Governments cannotachieve biosafety ontheir own: they need

the active involvementand cooperation of the

other stakeholders.

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Biotechnology could contribute significantly to the achievementof the objectives of the Convention on Biological Diversity andthe attainment of the Millennium Development Goals. However,it must be developed judiciously, and used with adequate andtransparent safety measures.

– United Nations Secretary-General Kofi Annan

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

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

The Secretariat of the Convention on Biological DiversityWorld Trade Centre

393 St. Jacques Street, Suite 300Montreal, Quebec, Canada H2Y 1N9

Phone: + 1 (514) 288 2220; Fax: + 1 (514) 288 6588E-mail: [email protected]: http://www.biodiv.org

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/