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ISNAR Briefing Papers examine policy and management issues affecting agricultural research indeveloping countries. They normally focus on advisory work or research recently completed or inprogress at ISNAR. The target readership are research managers, policy makers, donors, andacademics. Comments are welcome. Briefing Papers may be cited with acknowledgment of ISNAR asthe source. Copyright © 2002, ISNAR, The Netherlands.

Briefing PaperInternational Service for National Agricultural Research March 2002

47A CONCEPTUAL FRAMEWORK FORIMPLEMENTING BIOSAFETY: LINKING POLICY,CAPACITY, AND REGULATION

Morven A. McLean, Robert J. Frederick, Patricia L. Traynor, Joel I. Cohen, andJohn Komen

Products arising from modern biotechnology provide new opportunities to achievesustainable productivity gains in agriculture. Concerns over their possible environmentaland health implications stimulated regulatory mechanisms for food safety andenvironmental risk assessment. Over the past two decades, national biosafety frameworks,guidelines, and regulatory systems have often been implemented on a “piece-by-piece” basisin response to the demands or urgent needs of the moment. Ideally, a biosafety system wouldbe developed from a comprehensive plan. However, building such a system and making itoperational is complicated by the fact that there is no single best approach nor standard thatreflects national environmental, cultural, political, financial, and scientific heterogeneity.

Given these challenges and difficulties inherent in building regulatory systems and neededcapacity, the International Service for National Agricultural Research (ISNAR) convenedan expert consultation in July 2001. The purpose of this meeting was to develop aconceptual framework to address regulatory implementation and capacity-building needs ofdeveloping countries and Parties to the Protocol. A framework for implementing nationalbiosafety systems emerged, which consists of the following five elements:

� national policies, strategies, and research agendas regarding biosafety;� national inventory and evaluation;� the knowledge, skills, and capacity base to develop and implement a biosafety system;� development of regulations; and� implementation of regulations.

The conceptual framework clarifies critical decision points in the development of a nationalbiosafety system, systematically examines choices among policy options, and delineatessome of the scientific and social dimensions of these options. It complements ongoingregional and global projects that facilitate the development of national biosafety guidelinesand frameworks.

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Introduction

The conceptual framework for biosafety implementa-tion presented in this paper is based on a synthesis of thecontributions made to an international expert consulta-tion entitled “A Framework for Biosafety Implementa-tion: A Tool for Capacity Building.” Background for theframework and substantial documentation can be foundin the full proceedings (ISNAR, forthcoming)1.

The framework expands on the conceptual basis usedfor ISNAR’s national biosafety system studies in Egyptand Argentina (Madkour, El-Nawawy, and Traynor2000; Burachik and Traynor 2001) and on concepts andlessons derived from other national, regional, andinternational experiences analyzed during the consulta-tion.

The purpose of this framework is to address nationalneeds regarding regulatory implementation andcapacity building, in particular of those countries thatare Parties to the Cartagena Protocol on Biosafety. Theframework is meant to complement the UNEP/GEFGlobal Project on the Development of National BiosafetyFrameworks (Briggs 2001) by providing guidance on thedesign and implementation of regulatory frameworksand related capacity-building initiatives. It is notintended to be a common road map for all Parties orcountries to follow. Instead, the objective is to clarifycritical decision points in the development of a nationalbiosafety framework, to examine choices among policyoptions, and to delineate some of the scientific and socialdimensions of these options. The consequences of policychoice on the efficiency and effectiveness of biosafetyregulations are presented in more detail by McLean et al.(2001).

The Cartagena Protocol on Biosafety

Adopted in January 2000 as a supplement to the Con-vention on Biological Diversity, the Cartagena Protocolon Biosafety (the Protocol) addresses the safe transfer,handling, and use of living modified organisms (LMOs)that may have an adverse effect on biodiversity, takinginto account risks to human health and focusing specifi-cally on transboundary movements (CBD Secretariat,2000). The Protocol allows governments to indicate theirwillingness to accept imports of agricultural commodi-ties that include LMOs by communicating their decisionto the world community via the Biosafety ClearingHouse, a mechanism set up to facilitate the exchange ofinformation on, and experience with, LMOs. The aim isto ensure that recipient countries have both the opportu-nity and the capacity to assess risks involving the prod-ucts of modern biotechnology.

National, regional, and international agencies haverecognized that successful implementation of theProtocol is contingent on the development of nationalbiosafety capacity in countries that have yet to establish,or are in the process of establishing, biosafety systems.The Protocol makes clear that Parties to the Protocolmust develop or have access to “the necessary capacitiesto act on and respond to their rights and obligations.”The Protocol provides considerable flexibility as to howimporting countries may meet their obligations withrespect to risk-management decision making and to theimplementation of these decisions. As stated in Article16, which deals with Risk Management, each Party hasan obligation to “establish and maintain appropriatemechanisms, measures, and strategies to regulate,manage, and control risks identified in the risk assess-ment provisions” (CBD Secretariat 2000).

The Five Elements of the Conceptual Framework

The framework addresses five elements, identified by theconsultation participants as fundamental to the develop-ment and implementation of a national biosafety system(Figure 1). The first two—national policies, strategies, andresearch agendas regarding biotechnology and biosafety,and a national inventory and evaluation—provide thefoundation for subsequent regulatory implementation.The next element—requisite knowledge, skills, andcapacity base—is the resource environment within whichthe final two elements occur: development of regulationsand implementation of regulations.

As described here, national policies and the inventoryand evaluation do not lend themselves to the format

used to analyze the other three elements, where decisionpoints, policy options, and key questions were iden-tified. National biosafety strategy is discussed concep-tually, and national appraisal is addressed by broadlyidentifying the capacities available and needed toimplement the Protocol. Three crosscutting issues,common to each element of the framework, are alsoidentified and discussed: transparency, public partici-pation, and resources.

Using this framework to help build more comprehen-sive regulatory systems gains importance as developingcountries contend with increasing numbers ofapplications for confined field trials and commercial

1. The full proceedings and subsequent research provide comprehensive treatment of the framework by examining the specific elements and decision-makingprocesses, which is not possible in this briefing paper.

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release. Expanding needs for assessments requirecareful planning to build the necessary capacity baseand to clarify policy and system objectives to expeditereview decisions. Otherwise, review procedures will bedelayed not by the assessment, but by lack of clarityregarding policy or political matters (Paarlberg 2001).

Element 1: National Policies and Strategies

Ideally, the evolution of a national biosafety systembegins with the elaboration of a national policy consis-tent with other policy objectives related to food, agricul-ture, the environment, and sustainable development.This would form the basis for the development of spe-cific legislation and/or regulations, leading finally to thedesign and implementation of the structural elementsnecessary for risk analysis, inspection, monitoring, andenforcement. A national assessment of the existing sci-entific and technical capacity would support and informthe design process. This ideal progression is rarely thecase. In reality, portions of these activities are often com-pleted simultaneously, usually in an attempt to meetshort-term needs.

The importance of a national biosafety strategy cannotbe overstated as it provides a set of principles to guidesubsequent development and implementation of abiosafety system and regulations. Biosafety policyarticulates a national approach to biosafety regulationand the goals and objectives of the regulatory frame-work. It serves to integrate political, social, ethical,health, economic, and environmental considerationsinto decisions regarding the safe and appropriate use ofbiotechnology methods and products. A nationalstrategy may provide direction on many of the funda-mental issues and public policy choices that must beconsidered during the development of regulations.

Whether formulated prior to the existence of a regula-tory system, or subsequently, a national biosafety policyshould serve to articulate a framework whereby seem-ingly disparate goals, such as economic and regionaldevelopment, and environmental protection, may beintegrated and communicated as a single nationalvision. In addition, a national strategy should providefor the creation of some form of an advisory committeeto serve as a focal point for initiating public dialogue andaddressing crosscutting issues related to the ethical,legal, and social implications of biotechnology.

Element 2: National Inventory and Evaluation

A nation’s political and legal environment, including itssocietal philosophy, form of government (e.g. monar-chy, republic, tribal), legal framework (e.g. constitution,courts), and domestic stability, should contribute toframing the scope and content of a national biosafetysystem. An inventory and evaluation of nationalpriorities, agricultural policies, existing regulatoryregimes, and national scientific and technical means isideally a prerequisite to the development and imple-mentation of biosafety-related policies and regulations.This national appraisal provides a means to identify andcharacterize available resources and regulatory infra-structures, assess their adequacy for supporting abiosafety system, and identify gaps where capacitiesneed to be strengthened. The inventory should catalogthe following elements:

n existing regulatory structures and legislationpertaining to the import and export of agriculturecommodities, environmental protection, animal andhuman health safety, and biotechnology;

n existing mechanisms for the development of publicpolicy, legislation, and regulations;

n existing human, financial, and scientific infrastruc-ture;

n the current status of biotechnology research anddevelopment, including programs for the safe useand handling of LMOs;

n existing mechanisms for regional cooperation andregulatory harmonization;

n existing capacity building programs;

n the role of civil society in processes for policy andregulatory development; and

n administrative and enforcement capacity.

As previously mentioned, a country rarely reviews all ofthese items prior to actually managing/regulatingLMOs. More commonly, and perhaps more practically,countries evaluate their national capacities on a stepwisebasis, as dictated by domestic needs: the capability tomanage LMOs in contained facilities, followed byconfined small- and large-scale field trials, and finally,the unconfined release of an LMO. In countries that do

Nationalpolicy

Knowledge and Skills Base

Regulatorydevelopment

National inventoryand evaluation

Foundation

Regulatoryimplementation

Implementation

Figure 1. Basic elements providing for implementationof biosafety regulations

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not have domestic biotechnology programs, the nationalinventory and evaluation may be framed exclusively bythe requirements of the Protocol and the considerationwhether the country is importing commodities withLMOs for processing or for cultivation.

Element 3: Scientific Knowledge, Skills andCapacity Base

The human resource environment that both enables andlimits biosafety implementation is shaped by the scopeand quality of competency in the disciplines of bio-logical science; expertise in information acquisition,communications, and management; and experience incritical thinking, analysis, and decision making. Regard-less of whether a biosafety (or even biotechnology)policy is in place, or a national inventory and evaluationhas been conducted, these capacities have an overridinginfluence on the development and implementation of abiosafety system. A thin, weak, or limited knowledgeand skills base tends to produce regulations that arehighly protective, at the expense of innovation, poorlydefined or inconsistent, comparatively rigid, and/ornarrowly interpreted. A deep and broad knowledge,skills, and capacity base will foster more latitude in regu-latory development and more flexibility in regulatoryimplementation.

Fundamental to any national biosafety system is a strongbase of scientific knowledge in support of the regulatorysystem and the development of core competencies inbiotechnology product evaluation (figure 1; table 1).

These activities allow an improved scientific basis forassessments of potential risks and/or benefits, and theystrengthen the scientific capabilities for risk manage-ment, inspection, and monitoring.

Decision point 1: Coordinating scientific expertise

As the science involved in the creation of LMOs advances,and the products themselves become more complex,there is an increasing need to strengthen the science basesupporting risk assessment and regulation. Skills must bedeveloped for biotechnology product evaluation and tomaintain parity between risk assessors and their counter-parts working to create products. This requires constantupdating on new scientific advances, without which aregulator’s knowledge base has a limited life expectancy.

Adequate scientific capacity provides improved assess-ment of potential risks and/or benefits, and can improvethe quality of risk-management decisions and the capa-bility for inspection and monitoring. The limitations innational scientific and technical capacity identified dur-ing the inventory and evaluation can be addressedthrough a coordinated approach, which would aim toenhance domestic expertise through training while rely-ing on subregional, regional, and/or international coop-eration in performing risk assessments, on outsideexperts, and on the international academic community.

Decision point 2: Locating the science evaluationfunction

Structurally, different approaches to securing scientificadvice for decision making can be taken. In considering

Decision Point Policy Options Key Questions

1. Coordinated approaches toincorporating scientific adviceinto biosafety decision making

Development of national capacity forscientific risk assessment vs. coordinating riskassessment at a regional or subregional levelReliance on international experts vs. domesticself-sufficiency and capability

What is the state of biotechnology developmentnationally: is this expected to grow, and is there anexisting base of expertise which can be employed orenhanced?Does all of the necessary expertise reside within theregion, or must this be supplemented by the inclu-sion of external reviews and/or training?Are there shared values and regulatory approachesamong potential collaboratingcountries within the region?Is there a previous history of collaboration or coordi-nation in other regulatory arenas?

2. Locating the science evaluationfunction within the regulatorysystem

Development of core competencies for riskassessment within government departmentsand agencies vs. reliance on expert advisorycommittees vs. a combination of both in-houseand external scientific expertise.Concentrating the risk-assessment functionwithin a single identifiable body vs. distributingthis function among different governmentdepartments and ministries

Does the appropriate expertise currently residewithin the regulatory authority, or is it primarily withinacademic and other institutions?Is there government support and commitment for thedevelopment of expertise within regulatory agen-cies?Within government departments, are there adequateforesight mechanisms in place to identify potentialknowledge gaps, and are there existing avenues toaccess training or the recruitment of “new” knowl-edge?Should expert committees and advisory panels beused in all cases of product approval, or only toaddress specific issues of scientific uncertainty?

Table 1. Key Decision Points and Policy Options Related to Science and the Knowledge Base Supporting Biosafety Regulation

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the risk assessment of biotechnology products, somecountries have implemented a system of expert advisorycommittees, while others have relied primarily onscientists and professionals working within governmentagencies. In the latter approach, the mandate for riskassessment may be vested within a single agencyexclusively tasked with regulating products of bio-technology (e.g., a gene technology regulator) or it maybe distributed between agencies in accordance with theirexisting responsibilities (e.g., departments of health,agriculture and/or environment).

In general, independent advisory committees have moretransparent accountability frameworks than govern-ment departments and agencies, where the range ofexpertise and academic credentials of risk assessors israrely published. However, advisory bodies may sufferfrom the fact that committee members are part-timevolunteers who cannot devote their full energies to riskassessments. An approach to LMO regulation wherebyproduct evaluations performed by competent scientistswithin a regulatory agency are supplemented by theresults of issue-specific expert panel consultations maycombine the best of both approaches described above.

Element 4: Development of Regulations

Consistent with the vision of a national strategy,biosafety regulations may be developed to effect specificpublic-policy goals. Decisions on an appropriate regula-tory structure and the legal and political means by whichsuch a structure can be implemented should beinformed by the national inventory and evaluation, andthrough extensive consultation with stakeholders,including the public.

Some key elements to be considered in developing aregulatory framework are (1) the legislative framework,;(2) regulatory “triggers,” i.e., the criteria that— individu-ally or combined—make a product subject to regulatoryreview, (3) transparency and public involvement in thepolicy making, and regulatory decision makingprocesses, and (4) approaches to risk assessment and riskmanagement. These considerations introduce decisionpoints where the choices made will have a significanteffect on the subsequent development, implementation,and operation of the biosafety system. Critical decisionpoints together with policy options and key questions areelaborated in table 2 and discussed below.

Decision point 1: Legislative frameworkThe foundation of any biosafety regulatory system isauthority. Authority refers to the enabling legislation(acts, laws, decrees, and government orders) governingbiosafety. At the national level, this is the authority topromulgate regulations, supersede subnational authori-ties, intercede in trade or domestic movement, andimplement enforcement agencies. The establishment ofregulations (or executive orders) is necessary for

enacting prohibitions, restrictions, and requirementsunder the authority of national legislation. Authority isalso used to create policy instruments such as permits,guidelines, information requirements, etc.

In countries with established biosafety programs,regulatory oversight of LMOs generally began withnonbinding, voluntary guidelines. The designatedauthorities developed information guidelines andtechnology developers abided by these, and there is noevidence that the nonstatutory management of LMOsunder voluntary regimes has compromised environ-mental safety. The benefits of voluntary guidelinesinclude the speed by which they can be put in place andthe flexibility they allow to adopt revisions incorporat-ing new information requirements without delay.However, in the absence of a legal instrument, the publicmay not have confidence that the government is ade-quately regulating these products, or that developers arecomplying with voluntary guidelines. Additionally,enforcement powers may be limited in a voluntarysystem, depending on both the discretionary power ofthe competent authority to penalize a proponent fornoncompliance, and on opportunities for redressthrough the courts, should negligence be suspected.

Countries electing to develop a mandatory biosafety sys-tem have two choices for establishing legally binding reg-ulations: (1) they can develop a new act and regulations tospecifically address LMOs, or (2) they can regulate LMOsunder the auspices of existing legal instruments such asacts, regulations, and ministerial or presidential decrees.

The advantages of the former are the following:

n An act can be developed to specifically address theproduct or process to be regulated.

n It can provide flexibility so that new technicaladvances can also be captured without significantregulatory amendment.

n It can be perceived by the public as a positiveresponse to addressing concerns about the safety ofLMOs.

The following are disadvantages of developing a newact:

n Passing an act into law make take long, in particularin the politically charged environment around LMOsexisting in so many countries today.

n It may result in the regulation of LMOs in perpetuityso that, even if a history of safe use of a specific ge-netic element is established, LMOs with this elementwill still be singled out for exceptional regulatoryoversight.

Decision point 2: Regulatory triggersThe Biosafety Protocol is limited to addressing biosafetyconcerns that may be associated with the products of

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Decision Point Policy Options Key Questions

1. Legislativeframework

Existing, amended, or new legislation

Centralized (e.g., single “gene technologyregulator”) vs. Distributedresponsibility/authority

Is the scope of existing legislation sufficient to encompass prod-ucts of biotechnology?

Are there existing mechanisms for coordination ofrisk-assessment and risk management functions in the variousgovernment agencies that may be involved in biosafetyregulation?

2. Regulatory triggers Scope of regulatory oversight—product vs. process

Establishment of appropriate instrumentsfor comparing assessments – impacts onunmanaged vs. managed ecosystems;

Comparisons involving conventional, sub-sistence, or organic agriculture;

Should the trigger for regulatory oversight be based on someproduct characteristic or a process used in its manufacture?

What types of products and/or processes should be included?(e.g., imports, exports, animals, commodities, seed,processed products, etc.)

To what extent should scientific research, including themanipulation of genetically modified organisms, be regulatedand/or controlled?

3. Approaches to riskassessment and riskmanagement

Evidence-based scientific evaluation vs.consideration of socioeconomic factors

Consideration of risks and benefits vs. onlyrisks

Definition of safety standard(s)

How are risk factors for a particular commodity determined?

How should international standards and agreements (e.g., con-cepts of familiarity, substantial equivalence, and reasonable cer-tainty) be incorporated?

Should the assessment process distinguish demonstrable vs.hypothetical risks?

Who should be responsible for undertaking the necessary experi-mentation, testing and/or surveillance to satisfy risk assessmentdata requirements?

Other than risks, should the assessment include anexamination of potential benefits or other issues?

Should broader social, ethical, or economic issues befactored into risk-assessment decisions?

4. Transparency andpublic involvement

Public consultation (e.g., soliciting andacting on public input) vs. publicnotification, either before and/or after theregulatory decision

Public involvement in the development oflegislation and/or regulation vs. involve-ment in the decision-makingprocess

Should citizens be engaged in, or informed of, changingregulations and/or policy related to biotechnology, or theproducts derived there from?

In advance of a regulatory decision, should the public benotified of biotechnology products undergoing evaluation?

With respect to the application, should environmental or humanhealth supporting data be publicly disclosed?

In advance of a regulatory decision, should public input be solic-ited and considered?

Table 2. Key Decision Points and Policy Options Related to Biosafety Regulation Development

modern biotechnology, irrespective of the trait or traitsthat an LMO may express. This is an approach that relieson the use of in vitro nucleic acid or cell-fusiontechniques for producing LMOs as the trigger fordetermining what to regulate. Process-based triggers arethe rule in almost all countries that have developednational biosafety regulatory systems; there are excep-tions, however, where the novelty of the trait determinesthe extent of regulatory oversight and not the process bywhich the trait was introduced. While such a product-based approach to defining the object of regulation istruest to the scientific principle that biotechnology is notinherently more risky than other technologies that havea long and accepted history of application in agricultureand food production, it is less prescriptive than process-based regulatory systems.

It is more challenging for both developers and regulatorsto determine when a plant is in fact a “plant with a novel

trait” as opposed to the simple test of whether an LMOwas produced using recombinant DNA or cell-fusiontechnologies. Additionally, ensuring compliance withregulations prohibiting the importation of unapprovedplants with novel traits is technically and financiallyimpracticable. Unlike those products of geneticengineering where the genetic basis of the novel trait(e.g., the introduced DNA) is well characterized, plantswith novel traits produced by accelerated mutagenesisor wide outcrossing, for example, may not have anyreadily identifiable markers suitable for diagnosticscreening.

Decision point 3: Approaches to risk assessment andrisk management

Scientific risk assessment is the cornerstone of biosafetyregulatory systems and public-policy decisions relatedto the safety and acceptability of LMOs. A strongscientific capacity and knowledge base is viewed as key

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to identifying hazards and assessing their impacts andlikelihood.

There is good international consensus that risk assess-ments should focus on scientific consideration of the evi-dence or potential for adverse impact. This consensus isreflected in Article 15 of the Protocol, which asserts:“Risk assessments undertaken pursuant to this Protocolshall be carried out in a scientifically sound manner [...].”Annex III to the Protocol provides further details on riskassessment principles and a suggested methodology.There may be cases where other, nonscience factors areessential for making final decisions, however, theseconsiderations should be separate from the risk assess-ment process as such.

Policy decisions regarding the deliberate environmentalrelease of LMOs represent one area where scientificadvice has played a crucial but varying role in differentcountries. In Canada and the USA, science largely“determines” the regulatory decision, while in the Euro-pean Union, science is one consideration among otherfactors that play a crucial role in the decision makingprocess.

Decision point 3 (continued): Approaches to riskassessment and risk management—socioeconomicconsiderations

Worldwide, the most common approach to risk assess-ment is based on a consideration of the scientific evi-dence regarding various risk factors, tempered withvarying degrees of “precaution.” Seldom are benefits oreconomic issues considered, and nowhere is there asystematic consideration of social or ethical concernsrelated to the approval of a specific product.

The application of modern biotechnology to the geneticmodification of plants and in food production generallyhas given rise to widespread discussion on its social,ethical, and at times economic acceptability. Howshould these concerns, which largely relate to justice,beneficence, and respect for cultural diversity, be con-sidered within a product approval system, or moregenerally, within a national biosafety strategy?

There is no consensus on how best to reflect socio-economic concerns within a regulatory system. Theconsideration of quantifiable economic impacts may beconsidered a justifiable component of the productapproval process. In such cases, the creation of a regula-tory structure that allows separation of the scientific riskassessment and regulatory decision-making processes isadvisable. Such a tiered approach provides a system inwhich the regulatory decision is “informed,” both by thescientific risk assessment and by other considerations.The drawback of this approach concerns the extent to

which decisions may be subject to “political interfer-ence” or impinge on existing international tradeagreements. Adequate transparency, openness, andobjectivity are key to the successful implementation ofsuch an approach.

It does not appear feasible, nor advisable, to includebroader ethical and social considerations (excludingeconomic consequences) into the process for individualproduct approvals. These important considerations arebest dealt with by establishing ethics committees orother expert bodies responsible for providing govern-ments with policy advice on ethical, legal, or socialissues related to the adoption of new technologies. Theexploration of ethical issues can serve both to develop apublic consensus on the acceptability of various tech-nologies and to guide the evolution of a policy frame-work for regulation.

Decision point 3 (continued): Approaches to riskassessment and risk management—internationalagreements and trade

Beyond the Cartagena Protocol, there are other interna-tional agreements, conventions and treaties, such astrade agreements governed by the World Trade Organi-zation (WTO)2, and the Codex Alimentarius on foodstandards, governed by the World Health Organization(WHO) and the Food and Agriculture Organization(FAO) of the United Nations. Implementation of theseagreements may impact directly or indirectly on thedevelopment of a biosafety regulatory system. It isimportant that obligations under these agreements beconsidered when developing biosafety regulations, par-ticularly for those countries that anticipate exportingLMOs. Where possible, attempts should be made to har-monize with risk assessment criteria and standards thathave achieved international acceptance in either practiceor principle.

Decision point 4: Transparency and publicinvolvement

For this discussion, please refer to “Crosscutting Issues”on page 10.

Element 5: Implementation of Regulations

In general, the central issues around the implementationof biosafety regulations involve the establishment ofappropriate mechanisms for risk assessment, riskmanagement, and risk communication, while managingwithin existing financial, technical, and human resourceconstraints (Cohen 2001). Decisions made during theimplementation phase impact directly on the economiccosts associated with assessing and mitigating risks andensuring compliance. In addition to the key decisionpoints and policy options outlined in table 3, other

2. Relevant examples include the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers toTrade (TBT Agreement).

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Decision Point Policy Options Key Questions1. Harmonize risk

assessment atsubregional orregional level

Harmonize legislative authority vs. establish ashared “checklist” of essential elements ofbiosafety assessment for incorporation intoexisting national legal systemsEstablish agreement on general principlesfor biosafety risk assessment vs. establishagreement on methodologies and informationrequirements for risk analysesHarmonize administration of biosafetysystems to facilitate information exchange,notification, and compliance/monitoring activi-ties

Is there a history of subregional or regional regulatoryharmonization?Are there shared goals and objectives for cooperation?Are there established mechanisms or processes tofacilitate regional cooperation?

2. Internationalharmonization of riskassessments (for applica-tions relating to productspreviously approved inanother regulatory juris-diction)

Accept as equivalent to a domesticevaluation vs. require completeassessments domestically

What conditions would have to be met to establishequivalence for international data?Should there be a distinction between the equivalency of envi-ronmental and human food safety risk assessments?

3. Scientific evaluationand the breadth and depthof information required toreach adecision

Basic information (e.g., scientific rationalbased on previously published studies),intermediate, or extensive

Has the same product been approved in another regulatoryjurisdiction, or has a similar product been approveddomestically?Are there closely related wild species in the recipientcountry, or other complicating factors?Who is responsible for undertaking the necessaryexperimentation, testing and/or surveillance to satisfy riskassessment data requirements?Whether this activity occurs within the regulatory system (i.e.,within government), or externally, how are the veracity of thedata and the scientific soundness of the approach verified?

4. Transparency ofthe risk assessmentprocess and riskassessmentdecisions

Internal vs. external reviews and/orsupplementary opinionsPublication of deliberations/conclusions//decisions, before or after the fact

What formal, or informal, mechanisms exist for incorporatingoutside scientific expertise into the risk assessmentprocess?How are petitioners informed of the regulatory requirements,including assessment guidelines, for biotechnology products?With respect to the application and supporting data, how muchinformation is disclosed and how is the issue ofconfidential business information dealt with?How are regulatory decisions communicated to the public?How is new scientific information that may impact a prior regu-latory decision used to reevaluate decisions andcommunicated to the public?

5. Public engagementin the risk-managementdecision

No public involvement in the regulatorydecision making process, or only incertain cases vs. requesting publicinput in all cases

What are the mechanisms for soliciting and recording publicinput?Is there a distinction between stakeholder groups (e.g.,scientific societies, industry groups, nongovernmentalorganizations) and the public?If it does occur, how are public comments and/or concernsaddressed and reflected in the regulatory decision?To what extent are the comments and their responses aremade public?

6. Post-commercializationmonitoring andsurveillance

No post-market monitoring vs. short-term fol-low-up (less than 5 years) vs. long-term fol-low-up (more than 5 years)Follow-up for all organisms, or only for certainorganisms (e.g., those with wild relatives inthe host countryTime-limited vs. open-ended approvals

If post-market product surveillance does occur, are thererequirements for the segregation of agricultural commoditiesand/or labeling of food products?How are the results of post-commercialization monitoring com-municated with the public?What are the regulatory requirements, if any, for post-approvalreview and/or consideration of newinformation?

7. Compliance andenforcement

Levels of inspection and auditImposition of administrative and monetarypenaltiesTrade sanctions

Table 3. Key Decision Points and Policy Options Related to Biosafety Regulation Implementation

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important considerations include opportunities forinternational cooperation at a technical level (e.g.,sharing human and scientific resources and expertise)and establishing a scheduled phasing-in of regulations(e.g., initial voluntary guidelines entrenched in legisla-tion over time). The final step—putting the system intooperation—entails meeting requirements for the fourelements that allow biosafety implementation (Traynor1999) as follows:

n The regulations or guidelines clearly define thestructure of the biosafety system.

n The people are knowledgeable and well trained.

n The review process is based on up-to-date scientificinformation.

n Feedback mechanisms are used to incorporate newinformation and revise the system as needed.

Decision point 1, 2, and 3: Regional and internationalharmonization

Implicit in the Cartagena Protocol is the assumption thatsubregional cooperation in information sharing and har-monizing legal and regulatory systems is crucial foreffective management of transfer of LMOs acrossborders. Successful harmonization depends on thefollowing key factors: (1) the adoption of commonvalues and objectives, (2) shared interest and concerns;the existence of economic and other benefits, (3) the needto overcome differences and avoid disputes, (4) the needto cooperate against other interests, and (5) the need tosimplify procedures. In the absence of some or all ofthese factors, the chances of achieving effective harmoni-zation are limited. Harmonization can occur on threefronts - authority, risk analysis, and administration - asdiscussed below.

Harmonization of authority is the most difficult toachieve and the delegation of national authority to aregional or subregional body rarely occurs, if at all.Because of the diversity of legal systems, the develop-ment of model legislation or regulations is problematic.A more reasonable goal is to develop a checklist of essen-tial elements that can be incorporated into national legalsystems in different ways. Harmonization should focuson identifying and securing agreement on these coreelements, while balancing international and regionalobligations and objectives.

The harmonization of risk analysis principles, infor-mation requirements, and standards of assessment canbe instrumental to maximizing the use of institutional,financial, technical, and human resources within aregion. For small countries, where the national sciencecommunity is small, the ability to capitalize on externalexpertise and information may be a crucial condition forimplementing the Protocol. Harmonization of analysiscan occur at two levels. The first is conceptual, i.e.,agreement on general principles of risk assessment.

Examples of this include the Protocol itself, as well asconsensus documents on food safety and environmentalrisk assessment. Such documents form the basis forinternational agreements on risk assessment. The secondlevel is technical and involves agreement on methodolo-gies, information requirements, or criteria for determin-ing unacceptable risks.

Harmonization of administrative functions concernsprocedures for the implementation of norms, rules, andstandards. It includes things like record keeping,communication, information exchange, and notificationsystems. Within the context of the Protocol, one exampleof this type of harmonization will be provided in theform of a Biosafety Clearing House, which is themechanism for sharing scientific, technical, environ-mental, and legal information relating to the riskassessment and transboundary movement of LMOsamong the Parties.

Decision point 4 and 5: Transparency of decisions andpublic engagementIdeally, the process used to develop a national biosafetysystem should be transparent and the level of involve-ment of the public and/or stakeholder or special interestgroups as legislation, regulations, or guidelines arebeing developed, ought to be considered. Practically, theextent to which this happens mostly depends on pastpractices of the government in other areas. Additionally,decisions must be made as to the degree of transparencyand public involvement that the system will afford afterit is implemented, e.g., should the public be consulted ornotified before or after a regulatory decision or policychange is made. It is advisable for governments toproactively support a development process that is openand permits some form of public engagement prior tothe promulgation of acts and regulations or to thepublishing of guidelines.

As a minimum, the process and criteria for risk assess-ment and risk management should be widely publishedso that developers, stakeholders, and the public can trustthe biosafety system to be both credible and predictable.Some jurisdictions have surpassed this level: theyadditionally notify the public when applications for theenvironmental safety assessment of a geneticallymodified organism are received by the competentauthorities, and also when a regulatory decision is made.

Within the context of implementing a biosafety system,opportunities for public engagement may be providedthrough formalized requests for public input. Mostcommonly, the public is provided with an opportunityto evaluate summary information about the LMO underreview and to submit comments in this regard.

Decision points 6 and 7: Monitoring and compliance

Internationally, no country has implemented a system-atic process of post-market (or post-approval) moni-

10 ISNAR

toring or surveillance for. Many countries recognize theneed for long-term monitoring of the cumulative effects,including benefits, of LMOs. However, there are signifi-cant complexities in implementing such programs. TheBiosafety Clearing House will facilitate a timely

exchange of information about the transboundarymovement of LMOs. However, there remain otherpractical, technical, and economic limitations tomonitoring for LMOs to ensure that national andinternational rules and regulations are respected.

Crosscutting Issues

Crosscutting issues are the ones encountered duringeach stage of the development and implementation of anational biosafety system, and they are often the mostchallenging factors to address and resolve. These are theissues that will ultimately dictate the scope of a nationalpolicy on biosafety, and the conversion of policy intopractice. Crosscutting issues affect the implementationof the system designed to assess biosafety, and perhapsmore important, those nontechnical factors that are cru-cial to the public’s acceptance of and confidence in thedecisions that are made by government on behalf of thepeople.

Transparency

The twin issues of public information and participationrelate to the degree of transparency in a regulatorysystem and to the extent to which the public can provideinput to the formulation either of a regulatory policy, orof specific regulatory decisions. In this context, trans-parency refers to the amount and level of informationthat governments provide on why and how certainproducts are regulated, on how risk assessments areperformed and decisions made, and on what conclu-sions are reached. Transparency can also relate to theperceived independence and objectivity of the regula-tory decision makers. Although closely related, publicinformation and participation have some mutual exclu-sivity, as it is certainly possible to have an open andtransparent process that, however, does not involvepublic input.

Greater transparency concerning both the risks andbenefits of biotechnology products and governmentdecision making is an essential component of buildingpublic trust in new technologies. The dissemination ofmore and better information on agricultural biotech-nology is a stabilizing force because, while the publicmay not generally read scientific studies, riskassessments, or government-decision documents,opinion leaders, members of special interest groups, orothers who hope to shape public opinion, do.

Government policy on transparency will determine theextent to which the public and special interest groupswill contribute to the development of a national

biosafety policy; the opportunities for public participa-tion in the risk-assessment and decision-makingprocess; and the degree to which the public will haveready access to information about the biosafety system,the process of decision making, and the regulatorydecisions that are made.

Public Participation

Opportunities for public participation will necessarilyreflect the political and cultural environment of acountry. Countries with a history of citizen engagementin policy development are likely to include the public inthe process of developing a national biosafety system,and the converse is also true. Public participation in theevolution and implementation of a national biosafetysystem may be the most significant factor in determiningthe level of public confidence in the risk assessment andmanagement of LMOs.

Mechanisms for public participation include thefollowing:

n advisory committees, particularly those tasked withevaluating the social, ethical, and economic dimen-sions of biosafety, where one or more members ofthe public should be included;

n public hearings or individual contributions duringthe development and amendment of biosafetyguidelines and regulations;

n contributions during the risk-assessment process.This will require that the public be informed aboutproducts under review and provided with a processthrough which they can make submissions about theapproval of an LMO.

Resources

Human, financial, and infrastructure resources largelydetermine the scientific and administrative capacity ofany country and so obviously influence any biosafetyrelated policy or program (Cohen 2001). Funds must beavailable to develop and implement a national biosafetysystem; to support the infrastructure required, e.g.,buildings, labs, equipment, and computers; to facilitatecommunication and public participation; to train scien-tific and regulatory personnel; and to foster the researchrequired to assure that risk assessments are sound.

ISNAR 11

Concluding Remarks

Implementing a comprehensive, multifaceted biosafetysystem responsive to national regulatory needs and tovarious articles of the Cartagena Biosafety Protocol is acomplex, resource-intensive undertaking. The concep-tual framework presented here aims to clarify five inter-related elements and decision points for developing anational biosafety system, to examine choices among thevarious policy options, and to delineate some of the

scientific and social dimensions of these options. Neitherconceived as a definitive how-to guide for building anational biosafety system, nor designed to be one, theFramework is a tool for building capacity in developingcountries as they develop or reevaluate their biosafetysystems. Further research, case studies, and analysis arebeing planned to apply this framework to the individualexperiences of developing countries.

Acknowledgments

The authors wish to thank the contributors and review-ers of this report. We begin by thanking all participantsof the expert consultation, since as it was from their workthat the framework emerged. Additional reviews fromAmir Kassam, Cyrie Sendashonga and colleagues at the

CBD Secretariat, Piet van der Meer, and Catherine Iveswere critical to improving the content and informationof the paper. The paper benefited greatly from the com-ments from two anonymous reviewers.

References

Briggs, C. 2001. Planning for the Development of Nearly 100National Biosafety Frameworks. Paper presented at theinternational consultation A Framework for BiosafetyImplementation—A Tool for Capacity Building, organized bythe International Service for National AgriculturalResearch (ISNAR) and Virginia Polytechnic and StateUniversity (Virginia Tech), Washington DC, July 23-26,2001.

Burachik, M. and P.L. Traynor. 2001. CommercializingAgricultural Biotechnology Products in Argentina: Analysis ofBiosafety Procedures. ISNAR Discussion Paper No. 01-02.The Hague: International Service for National AgriculturalResearch.

CBD Secretariat. 2000. Cartagena Protocol on Biosafety to theConvention on Biological Diversity: text and annexes.Montreal: Secretariat of the Convention on BiologicalDiversity.www.biodiv.org/doc/legal/cartagena-protocol-en.pdf

Cohen, J.I. 2001. Harnessing biotechnology for the poor: challengesahead for capacity, safety and public investment. Journal ofHuman Development, Vol.2, No.2: 239-263.

Intergovernmental Committee for the Cartagena Protocol onBiosafety (ICCP). 2000. Indicative Framework for CapacityBuilding under the Cartagena Protocol on Biosafety. Montreal:Secretariat of the Convention on Biological Diversity.

ISNAR. forthcoming. Proceedings of the internationalconsultation A Framework for Biosafety Implementation – ATool for Capacity Building, organized by the InternationalService for National Agricultural Research (ISNAR) andVirginia Polytechnic and State University (Virginia Tech),Washington DC, July 23-26, 2001. The Hague: Interna-tional Service for National Agricultural Research.

Madkour, M.A., A.S. El Nawawy, and P.L. Traynor. 2000.Analysis of a National Biosafety System: Regulatory Policiesand Procedures in Egypt. ISNAR Country Report No. 62. TheHague: International Service for National AgriculturalResearch.

McLean, M.A., D.J. MacKenzie, and B.A. Cole. 2001. PolicyChoices in the Development of National Frameworks forBiosafety Regulation. Report for the International Service forNational Agricultural Research (ISNAR), The Hague.

Paarlberg, R. 2001. The Politics of Precaution: Genetically Mod-ified Crops in Developing Countries. Baltimore: JohnsHopkins University Press.

Traynor, P. 1999. Biosafety Management: Key to TheEnvironmentally Responsible Use of Biotechnology. Chapter 13in Managing Agricultural Biotechnology - AddressingResearch Program Needs and Policy Implications, edited by J.I.Cohen. Wallingford: CABI Publishing.

About the Authors...

Dr. Morven A. McLean is President, Agriculture andBiotechnology Strategies Inc. (AGBIOS), Canada. Robert J.Frederick is a Senior Scientist at the National Center forEnvironmental Assessment of the US Environmental Pro-tection Agency. Patricia L. Traynor is a Biosafety Special-ist for international development programs in agricultural

biotechnology, and is based at the Fralin Biotechnology Cen-ter, Virginia Polytechnic Institute and State University,USA. Joel I. Cohen is Project Leader, Management of NewTechnologies, at ISNAR. John Komen is an Associate Re-search Officer at ISNAR’s Biotechnology Service (IBS).

12 ISNAR

About ISNAR: The International Service for National Agricultural Research(ISNAR) assists developing countries in making lasting improvements inthe performance of their agricultural research systems and organizations.ISNAR promotes appropriate agricultural research policies, sustainableresearch institutions, and improved research management. ISNAR’sservices to national research are ultimately intended to benefit producers

and consumers in developing countries and to safeguard the naturalenvironment for future generations. A nonprofit autonomous institute,ISNAR was established in 1979 by the Consultative Group on InternationalAgricultural Research (CGIAR). It began operating at its headquarters inThe Hague, the Netherlands, on September 1, 1980.

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