Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks

Socio-economic Considerations in Biosafety andBiotechnology Decision Making: The CartagenaProtocol and National Biosafety Frameworksropr_488 171..196

Jose Benjamin Falck-ZepedaInternational Food Policy Research Institute (IFPRI)—EPTD

Patricia ZambranoInternational Food Policy Research Institute (IFPRI)—EPTD

Abstract

Article 26.1 of the Cartagena Protocol on Biosafety left open the possibility for member countries toinclude in their biosafety regulatory processes the assessment of socio-economic considerations. Countriesmay also decide to include such assessments as part of their national legislation or regulations for theapproval and deliberate release into the environment of genetically engineered technologies. Countries aredebating if and how to implement assessment of socio-economic considerations. This paper contributes tothe ongoing policy dialogue by discussing issues related to socio-economic assessment including scope,timing, inclusion modalities, methods, decision-making rules and standards, and the integration ofsocio-economic assessments in biosafety and/or biotechnology approval processes. This paper also discussesthe implications of such inclusion for technology flows and public and private sector R&D. If inclusionis not done properly, it may negatively impact technology flows especially from the public sector and renderan unworkable biosafety system.

KEY WORDS: genetically engineered crops, biotechnology, biosafety, socio-economics, impact assess-ment, Cartagena Protocol on Biosafety, developing countries

Introduction

Biotechnology and its modern applications including genetically engineered (GE)crops1 have shown great promise in addressing specific producer and consumerconstraints in developing countries. When GE technologies became feasible in thelate 1970s and early 1980s, the scientific community and policy makers faced theneed of designing and implementing protocols and procedures to ensure theirproper safety assessment. Early biosafety regulatory design was based on existingregulatory systems in agriculture and in other sectors of the economy.

These experiences were incorporated into the 2000 Cartagena Protocol onBiosafety,2 an implementing agreement under the Convention on Biological Diver-sity, especially those procedures outlined in its Annex 3. The Cartagena Protocol isprimarily an international agreement formalizing biosafety assessments as a pre-condition for GE crop approvals for transboundary movements due to trade.3 Oncethe Protocol became operational in 2003, it became a major driving force for thedevelopment of national regulatory systems and has had an impact on—in somecases triggered the development of—public and private sector research policies andR&D innovation management, particularly for countries Parties to the Protocol.

The main objective of the Cartagena Protocol on Biosafety is “to contribute toensuring an adequate level of protection in the field of the safe transfer, handlingand use of living modified organisms resulting from modern biotechnology thatmay have adverse effects on the conservation and sustainable use of biological

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diversity, taking also into account risks to human health, and specifically focusing ontransboundary movements” (CPB, Article 1, p. 3).

National regulatory systems in many developed and developing countries havebroadened the environmental scope of biosafety assessments as described in theProtocol to include food and feed safety and other considerations of public interest.Furthermore, Article 26.1 of the Cartagena Protocol (see Box 1) opened the possi-bility of including the assessment of socio-economic considerations as part of thebiosafety decision-making processes. Even though a strict interpretation of Article27.1 limits the scope of socio-economic considerations’ assessments to impacts onbiodiversity, especially with an emphasis on indigenous and local communities, thewording of Article 27.1 opened a window for national laws and regulations tobroaden this scope beyond its narrow interpretation at their discretion.

Box 1. Article 26 of the Cartagena Protocol on Biosafety

Socio-economic considerations

1. The Parties, in reaching a decision on import under this Protocol or underits domestic measures implementing the Protocol, may take into account,consistent with their international obligations, socio-economic consider-ations arising from the impact of living modified organisms on the conser-vation and sustainable use of biological diversity, especially with regard tothe value of biological diversity to indigenous and local communities.

2. The Parties are encouraged to cooperate on research and informationexchange on any socio-economic impacts of living modified organisms,especially on indigenous and local communities.

Source: Cartagena Protocol on Biosafety as part of the Convention onBiodiversity.

Some developing and developed countries, especially those parties to the Pro-tocol, have initiated discussions in Protocol meetings and other international policyforums, regarding the implementation issues for the inclusion of socio-economicconsideration assessments in biosafety decision-making processes. Many countriesare now actively seeking guidance in terms of how to include these considerationsin policy and regulatory framework formulation, as well as methods to use, imple-mentation approaches, and decision-making procedures. The term “socio-economic considerations” is a very broad term susceptible to the most diverseinterpretations. The contribution of this article is to provide some technical andregulatory procedural guidelines to delimit these interpretations and give someelements for regulators and policy makers to assess the costs and benefits of includ-ing socio-economic elements in the biosafety regulatory process.

As such, the scope of this paper is the organizational and institutional decisionsneeded to implement socio-economic assessments (SEAs) within the context ofbiosafety and/or technology decision-making processes. This article is not about thescience behind biotechnology product development, risk analysis procedures or thestate-of-the-art assessment methods for the SEA of such products; rather this paper

172 Jose Benjamin Falck-Zepeda and Patricia Zambrano

is about the knowledge, policies, and politics behind biosafety and biotechnologydecision-making processes that may affect such assessments in a regulatory process.

We argue in this article that if this process is not done judiciously, the inclusionof socio-economic considerations assessments may have a negative impact in R&Dand innovation policies and practices in industrialized and developing economies,affecting both the public and private research sectors who are conducting advancedbiotechnology research in regulated products.

We organize this paper as follows. First, we describe the rationale behind regu-lating GE crops. Second, we describe the biosafety and the biosafety assessmentprocess. Third, we discuss the relationship between the Cartagena Protocol onbiosafety, national regulations, and SEAs. Then we discuss the issues and implica-tions related to the inclusion or consideration of SEAs into biosafety decision-making processes and the relationship to research policies, R&D programs, andnational innovation efforts. We finalize the article with some concluding commentsand implications for developed and developing countries.

Biosafety and SEAs

Why Regulate GE Technologies?

When the first GE crops were in the early development stages there was already acritical mass of regulatory experience in other sectors such as the pharmaceuticaland chemical industries coupled with accumulated familiarity and knowledge oncrops, traits, and constructs for regulators to base their assessment and approvals.Initial protocols developed by scientists and regulators include those in the guide-lines derived from the 1975 Asilomar Conference (Berg, Baltimore, Brenner,Roblin, & Singer, 1975) and those compiled by international organizations such asthe OECD “Blue Book” (OECD, 1986). Both the Asilomar Conference—and toquite a degree the OECD guidelines—were written mainly by scientists for scien-tists. These documents carefully summarized all the elements of good practice forbiosafety assessments to date, based on the scientists’ accumulated experience andfamiliarity with state-of-the-art research, development, and regulatory processesfamiliar to them, including those in the pesticide and pharmaceutical industries.Using this knowledge, regulators and policy makers have been able to frame thedevelopment of modern biosafety regulatory systems within specific parametersand guidelines, while at the same time learning valuable lessons for biosafetyassessment and decision-making implementation.

First, a lesson learned is that any proposed biosafety framework needs to con-sider the fact that financial and human resources limit the scope of safety assess-ments. Second, regulatory systems need to address the fact that science hastechnical limitations for assessing every potential risk of GE crops, and, finally,countries have financial, institutional, and time limits to their ability of addressingrisk and risk taking. Functional biosafety regulatory systems have evolved andmatured over time not only by addressing these issues but also by weighting thedecision process with the fact that there are always trade-offs in procedures followedand that the status quo is not necessarily risk-free (Nuffield Council on Bioethics,2003).

Socio-economics, Cartagena Protocol, and Biosafety Decision Making 173

While there might be an initial desire to establish stringent regulations to a newtechnology as a precautionary stance toward potential risk, the accumulated expe-rience in other regulated sectors has shown that there is an inverse relationshipbetween regulatory intensity and technology deployment. In other words, inflex-ible and unnecessarily precautionary approaches to regulation will result in fewerpotentially beneficial products available to farmers and consumers. Given theseconsiderations, regulatory decision makers need to perform an assessment of safetygains compared to losses and gains derived from their decision-making outcomes.

Biosafety regulators face three distinct issues regarding decision making. First,regulators and regulations address the safety of GE crops. In essence, regulatorysystems attempt to prevent the introduction of potentially harmful technologies tothe environment and public health. Second, regulators may consider the efficacy ofthe regulated product. Here the regulator may be concerned with preventing theintroduction of unimportant or inefficacious technologies to society. Finally, therobustness of any regulatory system directly relates to the public confidence on boththe regulatory process and its determinations of safety and efficacy for regulatedproducts. Therefore, society is more likely to accept decisions from a robust bio-safety regulatory process.

What Is Biosafety Anyway?

To understand the potential entry points for the inclusion of SEAs in biosafetydecision making one must first understand what biosafety is and how countries haveimplemented biosafety assessments in practice. The Cartagena Protocol on Bio-safety does not explicitly define the term biosafety, leaving the parties to theProtocol the freedom to define biosafety in their own legislation.

The Biosafety Unit at the Convention on Biological Diversity defines biosafety as“a term used to describe efforts to reduce and eliminate the potential risks resultingfrom biotechnology and its products.” The Biosafety Unit’s definition can beexpanded to consider those processes which have been implemented within thescope of a regulatory system that enable a robust risk and benefit analysis ofgenetically engineered crops. Biosafety then considers, in this expanded definition,new technologies’ adoption evaluation with careful consideration of their potentialeffects on the environment and human/animal health.

This definition is very broad and reflects the fact that there cannot be a unique“best” approach to biosafety analysis (McLean, Frederick, Traynor, Cohen, &Komen, 2002). Each country bases its biosafety system on its own national, envi-ronmental, political, financial, and scientific capacities. The latter magnifies theimportance of framing biosafety within each country’s context as well as that ofglobal principles of risk analysis and regulatory experiences.

Experience within biosafety systems provide a systematic and ideally science-based foundation that society can expand to address multiple consumer and otherstakeholders’ concerns and conflicting issues deemed important by society. A func-tional biosafety regulation system may have significant benefits for society andshould ensure that the “right” technologies make it to market, while discardingthose technologies that do not work and/or that do not meet society’s safetystandard.


Biosafety approaches use aspects derived from competing regulatory para-digms. Some countries designed their regulatory systems so that they are learningand knowledge management processes. This is a characteristic of regulatorysystems in most countries where the system allows previous knowledge and famil-iarity with the crop and/or introduced genetic traits to play a role in contributingto the assessment of most products entering the regulatory pipeline. Examples ofcountries who have incorporated—to different degrees—learning and knowledgecomponents in their regulatory system include the United States, Canada, theE.U., Brazil, and Mexico.

Most biosafety systems, however, tend to incorporate some prescriptive processeshaving developers comply with a minimum set of activities. In most countries, adeveloper will have to submit information regarding the food/feed safety profile forthe proposed product. This is an assessment that may consider allergenicity, toxicity,and substantial equivalence to the conventional counterpart. Furthermore, devel-opers will likely submit data on the product’s environmental safety that may includeinvasiveness, impact on nontarget organisms, and impacts of agricultural biodiver-sity through representative species.

The degree to which a system prescribes activities as mandatory is quite debat-able as the process relates to the legal, political, and economic environment underwhich the biosafety regulatory process functions. Even in a country where thebiosafety approval process is technically “voluntary” such as the United States, it isunlikely that a developer will release a product without undergoing the competentauthority review due to potential liability concerns and the need to obtain a “sealof approval” for a product undergoing the biosafety assessment. The latter state-ment does not seem to be the case for insect-protected and herbicide-tolerant traits,which are covered by statutes under the U.S. Environmental Protection Agency’spurview, and thus for those traits environmental biosafety assessments can beconsidered mandatory. It is unclear whether other traits can be included undersuch statutes. In this sense, existing biosafety processes incorporate prescriptiveprocedures.

Note that what are prescribed in these assessment approaches are really theclasses of biosafety assessment (i.e., food/feed and environmental safety). A biosafetysystem, however, runs the risk of becoming excessively prescriptive if it mandatesspecific activities to developers in order to demonstrate that the product is safe forfood/feed or the environment. There is no country that we are aware of thatimplements a completely prescriptive biosafety system. The issue we wanted topoint out is that prescriptive approaches tend to take away the flexibility fordevelopers and even regulators to use alternative assessment procedures that maybe cost effective while delivering the same level of safety.

Biosafety Regulatory Approaches

Some biosafety systems have a stated science-based approach whereas others incor-porate political processes for decision making. Countries with a stated strict science-based approach include the United States, Canada, and Australia. Examples ofcountries that incorporate political components to different degrees and use differ-ent modalities within their decision-making process include those of the European


Union, China, Brazil, and Mexico. A strictly “scientific” approach to regulation maydisregard issues and concerns relevant to some sectors of society, while a “sociallybased” process that incorporates political issues runs the risk of special interestgroups interfering with the decision-making process with no objective justification.

Competing regulatory models further reinforce the idea that biosafety systemsrespond to national needs and capacities for regulatory assessment purposes. Fur-thermore, a regulatory system will be a reflection of pervading attitudes towardscience and decision making (Isaac, 2002, 2004). Notwithstanding the regulatoryapproach, regulators and safety assessors, as well as decision makers, face the factthat there is no technology or even human activity that can achieve 100% safety.In fact, all regulatory outcomes to date render a “safe” assessment and eventualdeliberate release approval, while reducing as much as possible regulatoryerrors.4

Proper application of scientific research and development procedures coupledwith science-based biosafety procedures have ensured, so far, a remarkable safetyrecord of accomplishment. To date there has not been any demonstrated damage ofany of the commercially released GE crops worldwide. Instances of purportedregulatory failures relate more to deficiencies of standard operating proceduresrequired for biosafety management than to the assessment process itself. Note thatthis outcome is a reflection of the developers’ desire to deliver safe and effectiveproducts, and regulatory system reducing the possibility of assessment errors.

Pursuance of greater precision and accuracy as well as the pressure from thegeneral public and particularly active civil society organizations has motivated somebiosafety regulatory systems to require more information than what would bereasonable for guaranteeing a product’s safety. Information gathering beyond thislimit is not only superfluous, but expensive and it may even require additionalactivities beyond those deemed as necessary and sufficient to demonstrate safety.The motives for pursuing a very small risk level—or alternatively zero risk—arebeyond the safety assessment and might as well be guided by other concerns suchas commercial product viability, potential liability, developers’ and/or regulators’inexperience, or in some cases a misguided pursuance of the precautionary prin-ciple by seeking reducing all risks to zero (see Figure 1).

Necessary or sufficient knowledge to determine a product as “safe”

Food/feed safety

Allergenicity

Toxicity

Composition substantial equivalenceEnvironmental safety

Gene flow and damage

Impact on nontargets

Impacts on agro-biodiversity or

biodiversity

Other motivations

• Liability• Marketing• Science and curiosity• “Excessive” precaution

Figure 1. Activities Conducted to Implement Biosafety Assessment Processes


The Biosafety Assessment Process

Most biosafety regulatory processes for GE crops consist of a sequential set of stepsthat require advance review and regulatory approvals by institutional, regional,and/or national biosafety committees (see Figure 2). A typical set of sequential stepsmay include laboratory trials, glasshouse/greenhouse (contained) trials, confinedfield trials, step up (extended) field trials, and commercialization, although thereare variations to the sequence presented in Figure 2.

The linear sequence of events in Figure 2 considers the possibility that each stepbuilds upon the accumulated knowledge in previous regulatory steps and/or thegeneration of additional knowledge submitted to regulatory authorities. Biosafetyregulators examine application dossiers submitted by the proponent consideringthe parent crop, the transformation method, the gene construct, and the GE cropfor health and environmental impact. All these activities conducted during theregulatory approval phase have a financial and time cost. Proponents need to inputfinancial biosafety regulatory costs to total development costs while society needs toconsider the impact of these costs to the flow of GE crop innovations.

Socio-economic Considerations and the Cartagena Protocol

As shown in Table 1, Article 26.1 of the Cartagena Protocol on Biosafety allows theinclusion of socio-economic considerations for biosafety decision making. As sum-marized in Table 1, a strict interpretation of Article 26.1 has a limited scope, specificimpact parameters, and the inclusion of assessments is subject to internationalobligations. The Protocol, however, leaves up to each country the discretion ofdefining socio-economic considerations impacts5 and developing their own nationalregulatory frameworks that may open the possibility for countries includingbroader assessments in the biosafety and biotechnology decision-making processes.

Practitioners can implement SEA at different levels, for example, at the house-hold, producer, community, industry, consumer, or trade levels (Smale et al., 2009).Practitioners can perform the assessment before or after adoption of the technology(ex ante or ex post, respectively). As practitioners need to address many problems

Figure 2. Biosafety Regulatory Phases and Regulatory Decision Points


like proposing assumptions, models, and uncertainties—or the lack of sufficient oraccurate data—socio-economic impact assessment incorporates a significant shareof art into a social science assessment process. Social assessment processes use,however, scientific tools and methods for implementation.

If decision and policy makers decide to include socio-economic considerationsin the biosafety decision-making process, the first step that needs to be defined isthe purpose and objective for inclusion and most importantly the time when theassessment will be done. An impact assessment during the biosafety regulatoryassessment stage needs by definition to be ex ante as there is no deliberate (or general)release and thus no adoption. In turn, for monitoring post release or for standardtechnology evaluation purposes, the assessment is a conventional ex post procedure.

Regardless of the approach, countries need to evaluate carefully costs and ben-efits of SEA inclusion into biosafety decision making. Inclusion of socio-economicconsiderations implies an additional regulatory hurdle that may have a negativeimpact in terms of time or lost opportunity on the access to new technologies. Toreduce the impact of this regulatory burden, inclusion of socio-economic consider-ations must be done using clear decision-making rules and standards, while ensur-ing the biosafety system’s transparency and protectiveness (see Jaffe, 2005, 2006).

Furthermore, biosafety regulatory systems can improve society’s welfare by maxi-mizing the benefits from the inclusion of socio-economic considerations in technol-ogy decision making by improving the quality of decision making. Finally, inclusionof socio-economic considerations raises a question regarding who are the bestqualified people to make a decision about a specific technology with convincingarguments. Are they academics, government officials, regulators, consumers, orfarmers? We discuss the latter question in the biosafety and socio-economic politicssection of this article.

Although the issues and questions posed previously are quite important, a morebasic question to answer is whether a robust regulatory system should includesocio-economic considerations, especially when taking into account that those con-siderations could potentially prevent the deployment of inefficacious technologies.Furthermore, biosafety regulatory systems must be prepared to answer the questionof what will be achieved in terms of societal welfare gains from the inclusion ofsocio-economic considerations into biosafety and biotechnology decision making.

To date, most biosafety systems have focused only on safety, and there are only afew countries that have included socio-economic impacts in their legislation. The

Table 1. Comments on Specific Components of Article 26.1 of the Cartagena Protocol on Biosafety

Text of article 26.1 of the Cartagena Protocol on Biosafety Comments

1. The Parties, in reaching a decision on import under thisProtocol or under its domestic measures implementing theProtocol,

Focus is on a) Import decisions and/or b) Issuesincluded under domestic laws and regulations

. . . may take into account, Voluntary, it is not mandatory to considerSocio-Economic Considerations

. . . consistent with their international obligations, Especially with World Trade Organizations (WTO)

. . . socio-economic considerations arising from the impactof living modified organisms on the conservation andsustainable use of biological diversity,

Strictly a narrow scope on environmental issues.

. . . especially with regard to the value of biological diversityto indigenous and local communities.

Text seems to direct parties to a suggested impactparameter and assessment focus


few examples include Argentina on trade, and the European Union on periodicpost-approval socio-economic impacts, although there is very little clarity on howinclusion is likely to be implemented in the latter case. There are nevertheless manycountries that have indicated their plans to include socio-economic considerationsin their decision-making processes. Falck-Zepeda (2009) and Falck-Zepeda, Wes-seler, and Smyth (2010) lists some of these countries including Brazil, Philippines,Indonesia, Nigeria, and South Africa. Another study by Mulenga and Shunwa-Mnyulwa (2010) in Southern Africa, lists a set of countries with a contrastinglydiverse biotechnology innovation development and biosafety capacity includingMalawi, Namibia, South Africa, Swaziland, Zambia, Zimbabwe, and others. Thesesame studies, however, confirm that despite this growing interest very few countrieshave developed any guidance in terms of defined assessment processes, standards,or decision-making rules.6

Whether the inclusion of these socio-economic considerations is aiding a moresolid regulatory process is yet to be assessed in the specific context of individualdeveloping countries. Assessing the robustness of socio-economic considerationsinclusion has to consider that biosafety regulatory systems, as with any decisionmaking process, may render outcomes that are either correct or incorrect. Thisdecision contrasts with the actual state of nature of regulated products that areeither safe or unsafe. Combinations of these four parameters render two outcomesthat are desirable and two that constitute regulatory errors (see Table 2). Depend-ing on society’s desire to avoid undesirable outcomes, society may choose to mini-mize the possibility of approving a harmful technology or alternatively reducing thepossibility of not approving a safe technology. Inclusion of socio-economic consid-erations complicates decision based on these biosafety regulatory outcomes byintroducing not only some additional parameters to the decision-making process,but potentially competing decision-making rules.

An important question regarding regulatory outcomes presented in Table 2 iswhether harmful/ineffective technologies are the only ones excluded by regulations.The answer to this question is that regulatory systems have not approved in the pastsafe and effective technologies and thus society has lost with this type of regulatoryerror.7 With the inclusion of socio-economics, society may face indeed the potentialof having a regulatory outcome where there may be robust and positive biosafetyassessment coupled with a weak but negative SEA. The question then becomes whatwill decision makers do with this information?

Issues with Regard to the Inclusion of Socio-economic Issues in Biosafety

Policy makers and regulators, who intervene in designing a biosafety system andwho may consider inclusion of SEAs into biosafety and/or biotechnology decision

Table 2. Biosafety Decision and Outcome Matrix

Regulatory body action

Approve new biotechnology Do not approve new biotechnologyState of Nature Biotechnology safe Correct Incorrect

Biotechnology not safe Incorrect Correct

Adapted from Intriligator (1996).


making, need to address a set of concerns before settling into a specific approach.Discussion of the following issues will emphasize those concerns for ex ante evalua-tions although the discussion for ex post assessments in a post-release monitoringsituation is likely to face similar issues.

Definition and Scope

The procedure for inclusion of socio-economic considerations must first definewhat socio-economic considerations are and thus also define whether the standardor operating procedure will follow a strict interpretation of Article 26.1 of theCartagena Protocol or will consider a broader mandate under national regulations.Implementing regulations need to define whether to include socio-economic issuesonly, or if they should be broadened to include, as some stakeholders appear tosuggest, ethical, philosophical, or religious considerations.

Examples of national and regional legislations requiring the inclusion of issuesbeyond socio-economic considerations are Executive Order 514 in the Philippines(GoP, 2006), 2006 GMO Amendment Act 23 of South Africa (GoRSA, 2007) and theAfrican Union Model Law (African Union, 2008). As described earlier, many coun-tries in Southern Africa and other parts of the world have also indicated that theymay require inclusion of socio-economics in biosafety decision-making processes(Falck-Zepeda, 2009; Falck-Zepeda et al., 2010; Mulenga & Shunwa-Mnyulwa,2010).

Inclusion of broader considerations will expand the range of questions, methodsto be used for the evaluation, and certainly the cost of implementing suchregulations. At the same time, regulatory systems need to define method feasibilityespecially for ex ante evaluations as the assessment of products that have not yet beenadopted has limited data and thus have to be based on a set of many subjectiveassumptions. For example, SEA practitioners can describe the potential ethical,religious, and philosophical impacts from the adoption of a GE crop by usingqualitative and participatory approaches for evaluation. Requesting a quantitativemeasurement of these same issues in an ex ante framework can be futile for imple-mentation in practice. Furthermore, incorporating results from broader-typeassessments to regulatory processes might be hard to accomplish for decisionmaking as it incorporates subjective values, difficult to incorporate in a biosafetyassessment.

In addition to the definition of what socio-economic considerations to include inthe assessment, implementation regulations need to define whether inclusion ofSEAs is mandatory (i.e., required by national regulations or procedures) or volun-tary for an application. Mandatory requirements without clear decision-makingprocesses and standards may lead to an unworkable system as decisions may betaken upon a subjective decision-making framework and in some cases subject tospecial-interest-group pressures. In the case of voluntary procedures, with orwithout clear decision-making processes and standards, developers may not deemit important to conduct such studies and thus deprive society of much-neededinformation about new and emerging technologies.

If one compares the situation of a voluntary system (United States or Canada)with the experience of a mandatory but well defined—in terms of scope and


decision standards—system such as Argentina, the level of effort needed to complywith this requirement seems reasonable. If the comparison is done with a countrywhere there have been socio-economic studies but where there has not been clarityin terms of how they were used for decision making (for examples from India andto some degree China, see Pray, 2010), one can begin seeing that either thesocio-economic did not contribute much to decision making—thus a waste ofvaluable resources—or it introduces more complexity into a system, while notnecessarily guaranteeing a better regulatory outcome.

Timing—When to Require SEA?

Inclusion protocols need to define when is the appropriate stage for the proponentto include socio-economic considerations assessment for review by the regulatorybody. In those systems where inclusion is mandatory, policy makers need to raiseseveral questions. Will inclusion procedures require (or consider) socio-economicconsiderations during laboratory/greenhouse, confined or multi-locational fieldtrials, or during commercialization applications? Will the biosafety system consideronly those assessments after deliberate or general release? For example, can an SEAcan be considered a requirement for renovating temporary commercializationpermits customarily given to proponents in most countries as done by the EuropeanUnion?

As the technology progresses through the regulatory pipeline, developers maygather additional information regarding the field performance—although in mostcases practitioners have to be cautious with the interpretation as it is experimentaldata—of the technology and thus it may be worthwhile to wait for later stages of theregulatory process.

An important consideration for society is that spending scarce resources onproducts that the developer will not release is a waste of money and resources.Therefore, inclusion protocols that require SEAs from laboratory through confinedfield trials are quite unjustified as many of the products will not survive theevaluation process. Certainly, requesting a socio-economic study for the commer-cialization application process can be justifiable in terms of resource utilization. Thedesirability of holding the requirement of a socio-economic study until the com-mercialization approval process (general/deliberate release) has to be included inthe regulatory guidelines for implementation in order to ensure transparency,consistency and legal backing to the process.

Implementation Modalities of the Socio-Economic Inclusion Process

Countries have several options on how to implement the inclusion of socio-economic considerations into biosafety regulatory processes.

No Mandatory Inclusion—The first option is no inclusion of socio-economic consid-erations in biosafety and/or technology decision-making assessments. This is thecurrent approach followed both in the United States and Canada. The regulatorysystem relies only on the scientific risk assessment for approvals of confined fieldtrials and general/deliberate release. The rationale behind this alternative is that


developers screen the technologies for efficacy, regulators for safety, while farmersdecide which technology is best for their context.

Certainly, the possibility exists that developers may volunteer a SEA as part ofthe application dossier, but in this regulatory option, it is not mandatory for thedeveloper to include such assessment or for the regulatory bodies to consider theassessment itself. Falck-Zepeda and others’ (2010) argument is that the noninclusionin these countries is a consequence of having a strong judicial system that resolvesany potential liability issue via courts and the legal system.

SEAs do provide much-needed information in many situations. A major issue,however, is that there is very little clarity on what will regulators and/or decisionmakers do with the information generated by the assessment. For example, if asocio-economic assessment renders a negative evaluation where the technologyperformance is directly influenced by institutional constraints, not by the technol-ogy proficiency, would the decision-making outcome be to reject the technology? Ifthis is so, then decision makers may be penalizing the assessed technology undulywhen in fact the need exists to address the institutional constraints in the first place.In another scenario, will decision makers accept a safe technology having a positivebut highly variable distribution of outcomes? Some of these outcomes perhapsimply a “riskier” production process but with high income possibilities for farmers,thus becoming a decision-making-under-risk process, which many countries maynot be prepared to undertake at this time.

Even when conducting a robust assessment, SEAs continue to incorporate moreaspects of art in an approach that uses scientific tools and methods. Thus estimatesfrom SEAs can vary significantly. Different assessors can provide different—maybeconflicting—SEAs, even when applying robust assessments methods. If the mainstakeholders, farmers, and consumers are the ones who will endure both theconsequences of right and wrong regulatory decisions, it strengthens the argumentfor these stakeholders to be the ones who actually make the adoption and usedecisions. We discuss this issue further in the last section of this article.

Concurrent But Separate—A second option is to have concurrent but separate pro-cesses for risk and SEAs, preferably by different assessors. In this regulatory processoption, a technology decision-making entity commissions or conducts both assess-ments and renders a decision. This option has the benefit of potentially reducingtime delays and limiting the influence of politics (as opposed to fact gathering) inthe assessment process. Examples of countries that have implemented thisapproach include Brazil and to a certain degree India.

Sequential—A third option is a sequential approach where proponents or profes-sional evaluators perform the risk assessment first. Only if the technology demon-strates its safety does it proceed to a SEA before approval. Similar to the concurrentapproach, this option isolates the risk assessment from politics while leaving theoption open of considering politics in the technology decision-making process. Atthe same time this approach poses the risk of unnecessarily delaying the approvalprocess.

An example of a country that follows this approach is Argentina, although theSEA there only considers impacts of the potential adoption on trade, specifically the


competitiveness of Argentinean exports. The case of Argentina is quite instructive asit provides an example of an evaluation process that has a relatively well definedtrigger for conducting socio-economic studies, as well as scope and methods. Argen-tina’s inclusion of SEAs is quite implementable in practice due to its focus and beingdefined process with relatively clear decision making standards.

A variation of this option is the approach followed by the European Union thatnow seems to require a post-release monitoring for those temporary approvals forcommercialization purposes. In contrast to the Argentinean example there is verylittle guidance in the EU process in terms of scope, evaluation methods, anddecision-making rules and standards. Within the EU, the Netherlands through itsCommission on Genetic Modifications (COGEM, 2009) published in 2009 a reporton the potential role and inclusion of socio-economic evaluations within GM regu-latory processes. Interestingly enough, the European Union has apparently par-tially reversed its regional regulatory approach through the European Food SafetyAuthority and the European Commission for the approval of GM crops and nowhas granted its member states the ability to ban, accept, or request more informa-tion on a country-by-country and case-by-case basis, after regulatory approval bythe competent EU level authority. Whether this development implies that each EUcountry now has the ability of conducting socio-economic studies to back up theirdecision to approve or reject a specific technology is not known at this time.

Embedded—A final option is that of a SEA that is embedded and perhaps inter-twined with the risk assessment. In this option, the risk assessment is done at thesame time as the SEA, perhaps by the same regulatory agency. Depending on thebiosafety regulatory process outlined by a country’s specific regulations, the socio-economic and/or biosafety assessment may be done by different assessors, includingfull-time staff within the regulatory authority, third-party assessors, or the propo-nent. There is no strict separation between this option and the concurrent butseparate option described previously. The difference lies only in the fact that theimplementing agency conducts both assessments, which poses a risk that thisauthority might have further difficulty in advancing the process given the multipleobjectives it would be pursuing, and possibly facing potentially conflicting methodson how it should carry this process. Although this is a valid option for implementingSEAs, we are not aware of any country that has pursued this option.

Implementation Entity

If the regulatory decision makers opt to have SEAs, the first question that needs tobe addressed is who should be the implementing entity. Options include the pro-ponent, third entities commissioned by regulatory agencies, or professional asses-sors within the regulatory system. The choice of who will conduct the assessmentwill largely depend on the design of the remainder of the biosafety regulatorysystem. As McLean and others (2002) points out, each one of the options to build aregulatory system structure have trade-offs in terms of resources and capacities andwill directly relate to the country’s inventory of national capacities, the complexityof technologies being reviewed, and the volume of regulated technologies underreview.


Each entity choice has advantages and disadvantages. For example, when acountry’s regulation opts to accept the proponent’s submission for a socio-economicstudy, it will take advantage of the proponent’s familiarity and access to all thepotential information available that they generate. On the other hand, the maindisadvantage would be potential conflicts of interest and credibility as questions canbe raised in terms of the objectiveness and bias in a study conducted by theproponent. In contrast, when the socio-economic study is commissioned to a thirdparty—including expert consultants, academics, or professional assessors, perhapswithin the regulatory system—the issue of bias and conflicts of interest would likelybe eliminated, but then the insufficient access to all information generated by thedeveloper becomes more difficult to attain.

Although there are very few instances of the review of socio-economic consider-ations’ inclusion in biosafety regulatory processes that we are aware of, Falck-Zepedaand others (2010) have described these options in implementing countries. Forexample, the competent authority in India, the Genetic Engineering ApprovalCommittee, commissioned external consultants to carry out economic assessmentson two existing technologies under review by the regulatory system, although theexisting law does not require specifically a SEA. The legislation and/or nationalregulations in Mexico (GEUM, 2005, 2008), Colombia (MoADR, 2005), and Brazil(GoB, 2005), provide the competent authorities with the flexibility of choosing whowill perform the SEA study and what type of socio-economic issues to explore.Competent authorities in Argentina don’t have such flexibility as regulations requirethat the SEA study performed to be implemented by a government agency under theMinistry of Trade (SAGPyA, 2007), but the scope is limited to impacts on trade.

Given these options, perhaps the most efficient alternative for developing coun-tries that have already included SEA studies as mandatory in the regulatory process,is to allow submission of socio-economic studies by proponents, followed up by athird party that assesses the validity of the proponent’s study in a peer reviewapproach. The third party assessor will need to have the power of requesting anybackground and substantive information related to the methods, data and estima-tion procedures, and assumptions from the developer in order to perform the peerreview. This can help clarify the assessment while empowering the third partyassessor in its evaluator mandate.

The Methods—How?

The timing of a SEA will largely drive the choice of methods that may be availableto practitioners. Data and information availability, as well as the research questionsand hypotheses to answer or test, will define the type of methods that practitionersmay use for SEAs. Table 3 considers a partial list of methods that may be availablefor ex ante or ex post assessments. Ex ante assessments will be largely used during thebiosafety regulatory approval for decision-making purposes. In contrast, ex postmethods will be used for post-release monitoring, for example in the case ofproducts given temporary regulatory permit pending further monitoring or in thecase of conventional technology assessment procedures.

As described by Smale and others (2009), ex post evaluations assessors may needto use multiple methodological approaches to address multiple research questions


but also to untangle many of the sampling and statistical biases that arise duringadoption. Furthermore, practitioners will probably need to conduct assessmentsduring multiple years to capture production variability and responses to abiotic andbiotic constraints. The choice of methods will hinge on the data availability andassessment resources and capacities.

Each one of the methods listed in Table 3 has specific data requirements and thusvary in terms of feasibility. For example, econometric/statistical adoption modelsrequire actual data and thus are of limited use for ex ante assessments. Certainly, thescope exists for using econometric/statistical methods for ex post assessments, wherethe limitation is the time and resources to collect the adequate volume of data. If thepurpose of the SEA is to evaluate adoption and technology impact ex post, thenpractitioners can follow the elements of best practice and lessons learned fromaccumulated assessment experience as described by Smale and others (2009); Qaim(2009); Maredia, Byerlee, and Anderson (2000); and Alston, Norton, and Pardey(1995).

In turn, ex ante assessments need to be clearly defined in terms of scope, methods,and issues. Furthermore, regardless of the specific assessment approaches to beperformed, the regulatory system needs to establish decision-making rules andstandards so that proponents, assessors, and regulators are clear in terms of how thedecision will be made. The least desirable regulatory system outcome is having aprocess that is unfeasible or unworkable as no regulatory decision could be ren-dered as an outcome.

Decision-Making Rules and Standards

The biosafety regulatory framework needs to define clearly methods, decision-making standard, and procedures used to assess socio-economic considerations inbiosafety regulatory frameworks. This implies setting elements of best practice notonly for conducting the assessment but also for decision making. The standard and

Table 3. Social and Economic Methods Used in Ex Ante and Ex Post Evaluations

For regulatory approval purposes (ex ante)For post-release monitoring or technology evaluation

purposes (ex post)

• Partial budget and stochastic partial budget• Cost/Benefit, Net Present Value and Internal Rate of

Return• Economic surplus and partial equilibrium trade models• Computable General Equilibrium Models• Linear and dynamic programming models• Simulation models• Real Options Models• Social Accounting Matrixes• Social Network Assessments• Gender and Generational Assessments• Poverty and Social Impact Assessment• Social Relevance Analysis• Demographic and Systemic Relevance Analysis

• All ex ante methods plus: Econometric / statisticalmodels including:� Instrumental Variables and Treatment models� Production and damage abatement models� Production risk models� Heckman two-step models

• Programming models• Simulation models• Rapid Rural Development Appraisal

Notes: (1) This is not an exhaustive list especially for the ex post methods. We are trying to reflect the range of methodsused for socio-economic assessments. (2) Ex ante methods need to consider the fact that there is no adoption in placeand thus rely on assumptions and/or baseline data that may allow projecting potential impacts on data. Practitionersface this major limitation in practice.


decision-making process needs to be transparent and predictable so that partici-pants in the biosafety regulatory process know what to expect during all stages ofthe biosafety regulatory process. Specifically, all stakeholders need to know inadvance whether the SEA should consider risks only, or will also include cost/benefits and risk.

In addition, developers and assessors need to know the evaluation criteriaincluding the standard for evidence, quality, and sufficiency (Falck-Zepeda, 2009).Any socio-economic or biosafety assessment that only considers risks and not thetechnology’s potential benefits will indeed penalize the technology regardless of itsmerits. The assessment may render a product safe by evaluating likelihood orprobability of occurrence and damage by deeming these factors as negligible ormanageable. If the assessment does not consider potential benefits or costs tosociety, then society is facing incomplete information about the technology and thushas an increased potential of rendering a wrong decision.

Furthermore, the decision-making standard and assessment procedure need tobe feasible and cost effective, while ensuring that the overall process is protectiveand efficient (Jaffe, 2006). This implies that regulators and policy makers need toconduct periodical Regulatory Impact Assessment reviews, which may help stream-line the process. Finally, as mentioned in the discussion of Article 26.1, inclusion ofsocio-economic considerations in national frameworks and biosafety regulationsneed to consider its compliance with binding international treaties especially theWorld Trade Organization. This is extremely important as countries need to avoidbeing liable to violations to the terms of signed international agreements. Furtherdiscussions with regard to the relationship between biosafety and WTO can befound in Falck-Zepeda (2009).

Assessment Triggers

An important issue to consider is whether the regulatory system would require aSEA for each submission or alternatively consider other possibilities such as requir-ing such assessments based on whether the proposed technology is considered anew event, that is, a new and very specific crop and gene construct combination thatconfers a specific trait to the receiving organism. If the requirement is to require anew SEA for each submission, and thus there is no major change in the specificassessed technology, then such requirement will result in redundant studies beingdone, which are likely to be a waste of resources. If an alternative is pursued suchas requiring a socio-economic study only for new events or even allowing referenceto previous studies of the same technology, then this is usually a preferred optionfrom the standpoint of regulatory efficiency and for being a more cost-effectiveoption.

Integrating Biosafety/Biotechnology Technical Issues with Socio-economics

This is perhaps one of the most contentious and difficult issue to resolve from aregulatory standpoint. As seen in Figure 3 regulatory decision-making needs toconsider inputs and methods from different disciplines. A typical applicationdossier for commercialization approval will have information on environmental,


food/feed safety, and perhaps socio-economic impacts and other considerations.Environmental impact assessments may consider for example gene flow assess-ments and impacts on nontargets, which in turn may have different considerationsof their own. In its review, a regulator will need to consider a set of potential riskissues and formulate a decision, which balances all considerations. It is important tounderline the fact that much of the environmental and food safety assessments areexpressed as likelihoods or probabilities of occurrence, and thus the possibilityexists of having conflicting evaluations from socio-economic and from environmen-tal risk assessment expressed in noncomparable units of measurement.

This issue may be avoided through the choice of assessment process. In thespecific case of a sequential approach, the GE technology undergoes the biosafetyassessment first and if needed or required the SEA. This means that the technologyis deemed safer for deliberate release before exploring the socio-economic impli-cations derived from deliberate release. This option has the additional advantagethat information generated during the biosafety assessment can be used in the SEA.

Implications Derived from Inclusion of Socio-economics

Compliance with Regulatory Regimes and a Reduction in the Number of NewProducts Released to Farmers

The possibility of noncompliance with biosafety regulations increases when a bio-safety regulatory system has to take into account socio-economic considerations,particularly if there is no clarity in terms of methods and decision-making stan-dards. The consequence of such regulatory outcomes will likely be a reduction in

Gene flow

assessment

• Likelihood of occurrence• Introgression into population• Persistence • Damage or benefits from gene flow occurring

• Impact on biodiversity—some people argue that “just the fact that gene flow happens is enough”

Impact on

nontargets

Socio -

economics

Food safety

Decision making

• Digestibility• Allergenicity• Acute toxicity• Substantial equivalence and composition changes

• Economic surplus • Cost/Benefit ratios•Profit• Gender and age differentiated impacts

• Adoption determinants• Labor impacts• Productivity and production changes

Figure 3. Biosafety Decision-Making Issues


the number of technologies that may be released to farmers and consumers afterregulatory review. This is especially true for those systems that make SEAs manda-tory but do not provide guidance in terms of assessment approaches nor clarity onhow the decision making will be implemented. Alternatively, excessively compli-cated rules and regulations for socio-economic inclusion that demand complicatedassessments that may not be even feasible, especially ex ante, will achieve the sameregulatory outcome.

Cost of Compliance Will Increase—Focus on the Regulatory Lag Delays

The inclusion of SEAs will create an additional hurdle in the regulatory process thatwill increase costs of compliance with biosafety regulations. Furthermore, depend-ing on the timing and scope, inclusion of SEAs may increase the time needed forcompletion of a biosafety regulatory assessment. There are a few studies that havedocumented the cost of compliance with biosafety regulations. For example,Kalatzaidonakes, Alston, and Bradford (2006) report a range of costs for a selectedset of developers of insect-resistant corn in the United States from $7.0 million to$15.0 million. The same study reports costs ranging from $5.5 million to $6.2million for herbicide-tolerant corn. An article by Redenbaugh and McHughen(2004) indicates that cost of compliance with biosafety regulations for horticulturalcrops can be as low as $1.0 million per allele, but can be as high as $5.0 million.

Falck-Zepeda, Cohen, Meinzen-Dick, and Komen (2002) and Cohen (2005) citeexamples from an expert consultation held at the International Service for NationalAgricultural Research in the Netherlands in 2002. Compliance costs varied from$700,000 for transgenic papaya in Brazil, to $2.25 million for transgenic rice inCosta Rica, and $4.0 million for transgenic soybeans in Brazil. The amountsinvested in complying with biosafety regulations vary significantly between coun-tries but are directly related to the number of activities performed. Highest costs areassociated with allergenicity and toxicology testing.

Even though these costs are relatively high, Bayer, Norton and Falck-Zepeda(2010) show these costs are not as economically important as the delays in theregulatory process. The authors evaluate, for example, that increasing cost ofcompliance with biosafety regulations by 400% will have a very small effect indecreasing the net present value (NPV) of four GE technologies for release in thePhilippines. However, relatively short delays of even 1–3 years, do significantlyreduce the NPV for the same technologies.

Based on these experiences, we argue that the impact of socio-economic studieslie not on their cost but on the possibility of introducing time binding lags to theprocess—Pray et al. (2006) estimate that in India, SEA studies are in the range ofUS$15,000–30,000—which is low compared with other safety assessments cost. Incontrast, a paper by Kikulwe, Wesseler, and Falck-Zepeda (2008) shows that delay-ing the approval of a fungal-resistant banana in Uganda costs its producersapproximately US$179 million to US$365 million annually. This is especiallyimportant for Uganda, as bananas are a staple crop in the country thus having adefinitive impact of poor smallholders’ farmers in the country.

Furthermore, higher compliance cost may reduce investment in the develop-ment of regulated products such as GE crops. Depending on the relative


contribution to society’s welfare, this may translate into a loss to society as theregulatory systems will be unable to release valuable and safe technologies tofarmers. In addition, higher compliance costs may translate into higher socialand/or private rates of return for regulated products and thus penalize public goodtechnologies. This may of particular interest for developing countries who mayhave crops and traits of strategic interest due to their high social and economicvalue, but where there is very little regulatory experience elsewhere and wherepublic sector R&D may have financial limitations for product delivery to resource-poor farmers (Falck-Zepeda & Cohen, 2006).

We can differentiate the impact of higher regulatory costs by sector. Higher costsmay force public research to invest more on nonregulated approaches. As cited inFalck-Zepeda et al. (2009), this may be happening already in Brazil and othercountries. In the case of public goods, the higher costs will impact directly who willpay for development costs. As R&D cost increase, the national research systems areless likely to be able to afford investments in regulated technologies. In turn, anincrease in development cost might push the private sector to direct their researchefforts to products with higher “private” returns.

James (2008) has documented an expansion in the adoption over time of GEcrops over the years, although this has been largely limited to four crops (cotton,maize, soybeans, and canola) and two traits (insect resistance and herbicide toler-ance). The reasons why almost all adoption has been limited to a set of crops andtraits developed by the private sector, can be explained in part by the high andincreasing cost of compliance with biosafety regulations. The private sector hassignificantly higher financial capacity to pay for these costs compared with thepublic sector in developing economies that operates under much limited financialrestrictions.

The R&D pipeline is expanding although the number of products that will beavailable in the market will still be mainly from these four crops plus rice (Stein &Rodríguez-Cerezo, 2009). The public sector in developing economies as docu-mented by Atanassov and others (2004) has been developing many products forspecific needs of nonindustrialized countries,

The cost of socio-economic considerations is important especially for public sectororganizations creating GE products in developing countries. Introduction of regu-latory delays in the regulatory process are even more important. It is important tounderline the fact that implementation of the Cartagena Protocol focuses on risk, inspite of its introductory statements seeking the rational and careful use of these—potentially valuable—technologies especially in developing countries. This is a majorissue, as implementation of biosafety regulatory processes based exclusively on risk,without considering benefits and costs from R&D to adoption, would unduly penal-ize GE technologies. Note that the latter is one important argument that supports theinclusion of SEAs into the decision-making process as assessors will be mandated toconsider positive and negative outcomes derived from benefits and costs.

Entry Barriers and Regulatory Uncertainty

Inclusion of socio-economic considerations may render a biosafety regulatoryprocess a nonfunctional process if it becomes an insurmountable regulatory hurdle.


This is especially true if regulations, regulators, or the biosafety assessment processrequire activities beyond those needed to demonstrate a socio-economic impactbased on the decision-making standard. This may be a result of inclusion of politicalprocesses that may cloud the assessment process by requiring answers to questionswhich may not be even feasible answering in an ex ante regulatory framework. Inboth situations, where socio-economic considerations increase the cost and time tocomplete a regulatory assessment process, this may constitute a barrier to entry forsmaller organizations and the public sector as they may be less capable of complyingwith a cumbersome or unworkable regulatory process.

Human and Financial Capacity Requirements for Assessments

SEAs of GE crops require a degree of skill and experience. It is not only necessaryto have expertise with socio-economic methods and approaches, but it requiresknowledge of the bio-physical sciences and the regulatory considerations that arerelevant to the assessment. Furthermore, GE crops add a series of challenges thatare not typical in the assessment of other agricultural innovations, such as intellec-tual property protection and imperfectly competitive input markets, differentiatedmarkets, institutional limitations, and the fact that they are knowledge technologies(Falck-Zepeda, Traxler, & Nelson, 2000; Smale et al., 2009). The methods andapproaches need to reflect the increased complexity that these technologies face foradoption and use. The experts needed to evaluate GE crops will need to addressthis complexity especially for those assessments done in ex ante frameworks as thereis usually very little data to base assessments on in the first place. These qualifica-tions for human capacity may become an important hurdle in implementing SEAsand one that will require the support provided to developing countries withoutsuch capacity in the near future.

Policy Options for SEAs’ Inclusion

Although the Cartagena Protocol on Biosafety does not mandate inclusion ofsocio-economic considerations in its decision making, it leaves the option for coun-tries to include such option under national legislation. Policy and decision makersin developing countries have to balance the increased complexity of a socio-economic consideration—made even more difficult if the assessment process con-siders ethical, religious, and/or philosophical considerations—against the potentialgains in knowledge and information that a socio-economic study can provide tosociety before deciding on whether to include socio-economic considerations intothe decision-making process.

Given the complexities of the analysis and uncertainty and insufficient data thatthat ex ante SEAs have to be based on, the inclusion of such assessments may addunnecessary and costly delays to the regulatory process that are difficult justify. Nothaving a mandatory inclusion of SEA in the biosafety process is certainly thesimplest and easiest option for decision makers in developing and developed coun-tries particularly when there is a long history and accumulated experience behindbiosafety regulatory implementation.


If after a careful assessment, however, a country decides that it still wants toinclude socio-economic considerations into its decision-making process, in spite ofthe many binding constraints for implementation, then it would be necessary for thecountry to establish a process that is transparent, feasible, robust, and cost effective.These considerations are similar to those required for the overall biosafety assess-ment process (Jaffe, 2005, 2006).

In essence, developing countries need to provide developers clear guidance interms of timing of evaluations, methods, scope, and the decision-making processthat will be followed by all stakeholders involved. The worst possible option is tohave an open-ended process where there is no clarity on how to conduct a SEAstudy, nor how the regulatory or technology decision-making body may conduct orcommission the assessment and contrast its results with the results of the biosafetyrisk assessment. The latter lends itself to too much inconsistencies, speculation, andlack of transparency that can be questioned by all stakeholders involved in theprocess, especially when the decision-making process unduly punishes a specifictechnology for institutional and/or governance issues that have nothing to do withthe performance of the technology itself.

As described previously, the question to answer is what will a regulator ortechnology decision maker do with the information contained in a socio-economicstudy? If the results of the study indicate that society may face the situation of aproduct that is—or has the potential to be—a “technological triumph but aninstitutional failure” (Gouse, Kirsten, Shankar, & Thirtle, 2005), does the regulatoror technology decision maker reject the release of the technology? Should itsdecision be that the institutional limitations need to be addressed before releasingthe technology? Will this regulatory or technology decision outcome have anyimpact whatsoever on actually resolving the institutional limitations and who orwhat institutions will be the ones called to resolve such issue? Developing countriesneed to clearly provide answers to these questions so that the debates in terms of themerits from the inclusion of SEAs can be clearly defined upfront.

We argue here that predicating the approval of a technology on institutionalissues is indeed unduly penalizing the technology itself. Unduly penalizing thetechnology for factors external to its performance or safety can be magnifiedespecially when taking into consideration the uncertainties surrounding evenstate-of-the-art robust SEAs. This line of argumentation becomes a primary reasonto choose the simplest option of not having a mandatory inclusion of socio-economic considerations that countries may chose to consider in their decisionmaking.

Concluding Comments

Socio-economic considerations need to be assessed within clearly defined standardsand guidelines including methods, timelines, decision-making standards vis-à-visrisk assessments. If socio-economic considerations are done within these standardsthey can be a powerful tool for the valuation of upcoming new technologies espe-cially GE crops. On the other hand, if biosafety regulatory frameworks do notclearly define the inclusion of socio-economic considerations or such considerationsbecome an insurmountable hurdle, the result will be the reduction of potentially


valuable technologies to farmers and consumers. Unreasonable regulatory delays oruncertainty can affect negatively the stream of societal benefits derived from theadoption of GE crops as developers tend to invest less in such environments or shiftto nonregulated technologies. This outcome has to be weighed against the potentialdamage from those technologies that are indeed harmful and regulatory approvalerrors with positive and negative impacts.

Inclusion of socio-economic considerations in a biosafety assessment in any ofthe modalities discussed in the paper, especially when the process does not clearlydefine the modality of inclusion, can increase the cost of compliance with bio-safety regulations. If this is the case, then inclusion of socio-economic consider-ations may become a significant “barrier to entry” for some developers. The latterdevelopment is of interest especially to those entities developing pro-poor tech-nologies including international agricultural research centers and the public and(domestic) private sectors in developing countries that may not have resources tocover additional regulatory burdens beyond those necessary for the biosafetyassessment.

Finally, policy makers need to address the issue of regulatory predictability.Regulatory uncertainty can become a disincentive for R&D investments. In thisscenario, the public sector or those interested in developing technologies with apublic good nature are likely to be impacted more than technologies with a privatenature. Furthermore, impact of regulatory uncertainty on R&D and tech transferinvestments will be critical for future technologies not only GE crops but for othertechnologies in the agricultural research pipeline.

Acknowledgments

The authors would like to thank the member of the RAEIN-Africa Network, especiallyDoreen Mnyulwa, Marnus Gouse, Abisai Mafa, Margaret Sikwese, Elrod Naomab, DorothyMulenga, and Patricia Masanganise for their extremely valuable comments to this paper.The authors would also like to acknowledge that this paper is part of the activitiesimplemented within the Program for Biosafety Systems at the International Food PolicyInstitute. PBS activities are made possible by the support from the Office of Administrator,Bureau for Economic Growth, Agriculture and Trade/ Environment and Science Policy,U.S. Agency for International Development, under the terms of Award No. EEM-A-00–03–00001–00 and the International Development Research Centre (IDRC) from Canadawho made this paper possible. The opinions expressed herein are those of the authorsand do not necessarily reflect the views of the U.S. Agency for International Developmentor IDRC. However, all the responsibility of the content of this paper lies solely in theauthors.

Notes

1 Current products available to farmers are transgenic in nature—defined in the FAO Glossary (http://www.fao.org/docrep/003/x3910e/x3910e00.htm) as “an organism in which a foreign gene (a transgene)is incorporated into its genome. The transgene is present in both somatic and germ cells, is expressedin one or more tissues, and is inherited by offspring in a Mendelian fashion.” However, futureproducts may not be transgenic at all. In this article, we use the generic term for the process used toderive the product, that is, genetic engineering or modifications.

2 The Conference of the Parties to the Convention Biological Diversity adopted The Cartagena Protocolon Biosafety on 29 January 2000. The Cartagena Protocol entered into force September 11, 2003, 90


days after the receipt of the 50th ratification instrument. To date, there are 157 ratification instru-ments corresponding to the same number of party countries. There are 39 countries who have notsubmitted ratification instruments but who may participate as nonparties in the Cartagena Protocoldiscussions (see http://www.cbd.int/biosafety/signinglist.shtml).

3 One of the reviewers of this paper noted that the international biosafety protocols do not necessarilyensure safety. We agree with this statement, but pose the notion that it needs further clarification.Scientists developing a GE product and who are applying elements of best science will most likelydeliver a safe product. There is a high degree of confidence in the R&D process that unsafe orineffective products will be identified and discarded. Certainly for a public or private sector organi-zation, it is in its best interest to deliver a safe product in order to ensure maintaining its reputationand avoiding liability. This outcome is likely to hold in spite of the existence of formal biosafetyprotocols. What a protocol document such as the Cartagena Protocol does is to formalize a regulatoryprocess, although being an international protocol negotiated amongst parties with conflicting inter-ests, it can best be seen as the minimum acceptable procedure but one that does not give muchguidance for implementation.

4 This fact directly contrasts with strict interpretations of the precautionary approach contained in theCartagena Protocol on Biosafety, which require ensuring zero risk, which implies demonstratingimpossibility.

5 The Impact Assessment and Evaluation Group of the Consultative Group on International Agricul-tural Research (IAEG-CGIAR, 2000) defines “Impact” as “the broad, long-term economic, social andenvironmental effects resulting from research. Such effects may be anticipated or unanticipated,positive or negative, at the level of the individual or the organization. Such effects generally involvechanges in both cognition and behavior.” In turn the same source defines “Evaluation or Assessment”as the “judging, appraising, or determining the worth, value or quality of research (or any activity), interms of its relevance, effectiveness, efficiency, and impact.” In general, economics would focus withpecuniary (and nonpecuniary) costs and benefits. In contrast, sociology, anthropology, or politicalsciences would concentrate on impacts on people and institutions. However, with increased complex-ity, dividing socio-economic considerations into disciplinary lines may not be fruitful anymore due toincreased multi-disciplinary collaborations efforts.

6 The Biosafety Unit from the United Nations Environment Programme Division of Global Environ-ment Facility Coordination (UNEP DGEF) conducted an online survey on socio-economic consid-erations and biosafety. The survey had responses from 578 individuals or organizations. Reasonsgiven by respondents for the noninclusion of socio-economic considerations into GMO decisionmaking include issues such as not required by regulations, no implementation mechanismsavailable, political reasons, lack of institutional capacity, and others. A summary of preliminaryresults from this survey is available here: http://www.cbd.int/doc/meetings/bs/bscmcb-06/information/bscmcb-06-inf-02-en.pdf

7 The reason for the later regulatory outcome is that there is the need to comply with a “safety” standardand a set of decision-making rules. Furthermore, regulatory systems can commit regulatory errors. Inthe end, regulatory systems need to conduct a regulatory cost/benefit analysis of potential biosafetyregulations by answering the question of whether to undertake regulatory actions that are also costlyto undo over time. This analysis should consider the potential gains in knowledge from additionalexperimentation and thus a reduction in the uncertainty of regulatory outcomes (Wesseler & Ansink,2010).

About the Authors

José Falck-Zepeda is a research fellow at the International Food Policy Research Institute.His work at IFPRI focuses on the economics and impact assessment of biotechnology,biosafety, and emerging technologies. In addition, José focuses on agricultural R&D policyand technological innovation in developing countries. He earned his M.Sc. and Ph.D. fromAuburn University, Alabama.

Patricia Zambrano is a senior research analyst at the International Food Policy ResearchInstitute. Her work focuses on the evaluation of pro-poor crop biotechnologies and theeconomics of biosafety regulations programs. She earned a master’s degree in economicsfrom the University of California, Davis.


References

African Union. (2008). Revised African Union Model Law on Biosafety. AU Biosafety Project, African Union,Addis Ababa, Ethiopia. Retrieved February 1, 2010, from http://www.africa-union.org/root/au/AUC/Departments/HRST/biosafety/DOC/level2/DraftRevAMLBS_Jan08_EN.pdf

Alston, J. M., Norton, G. W., & Pardey, P. G. (1995). Science under scarcity: Principles and practice for agriculturalresearch evaluation and priority setting. Ithaca, NY: Cornell University Press.

Atanassov, A., Bahieldin, A., Brink, J., Burachik, M., Cohen, J. I., Dhawan, V., Ebora, R. V., Falck-Zepeda, J. B.,Herrera-Estrella, L., Komen, J., Low, F. C., Omaliko, E., Odhiambo, B., Quemada, H., Peng, Y., Sampaio,M. J., Sithole-Niang, I., Sittenfeld, A., Smale, M., Valyasevi, R., Zafar, Y., & Zambrano, P. (2004). To reachthe poor: Results from the ISNAR-IFPRI next harvest study on genetically modified crops, public research, and policyimplications. EPTD Discussion Paper 116. Washington, DC: International Food Policy Research Institute.

Bayer, J. C., Norton, G. W., & Falck-Zepeda, J. B. (2010). Cost of compliance with biotechnology regulation inthe Philippines: Implications for developing countries. AgBioForum, 13(1), 53–62.

Berg, P., Baltimore, D., Brenner, S., Roblin, R. O., III, & Singer, M. F. (1975, June 6). Asilomar conference onrecombinant DNA molecules. Science, 188(4192), 991–994.

COGEM. (2009). Socio-economic aspects of GMOs. Building blocks for an EU sustainability assessment of geneticallymodified crops. COGM Report CGM/090929-01. Retrieved from http://www.cogem.net/main-adviesdetail-signaleringEN.aspx?pageid=54&loc=2&version=&mode=&id=517

Cohen, J. I. (2005). Poorer nations turn to publicly developed GM crops. Nature, 23, 27–33.Falck-Zepeda, J. (2009). Socio-economic considerations, article 26.1 of the cartagena protocol on biosafety:

What are the issues and what is at stake? AgBioForum, 12(1), 90–107.Falck-Zepeda, J., & Cohen, J. (2006). Biosafety regulation of genetically modified orphan crops in developing

countries: A way forward. In R. Just, J. Alston, & D. Zilberman (Eds.), Regulating agricultural biotechnologiesand policy (pp. 509–534). New York: Springer Editors.

Falck-Zepeda, J., Cohen, J., Meinzen-Dick, R., & Komen, J. (2002, September). Biotechnology and sustainablelivelihoods: Findings and recommendations of an international consultation. ISNAR Briefing Paper 54.

Falck-Zepeda, J., Falconi, C., Sampaio-Amstalden, M. J., Solleiro Rebolledo, J. L., Trigo, E., & Verástegui, J.(2009). La biotecnología agropecuaria en América Latina: Una visión cuantitativa. IFPRI Discussion Paper860SP. Washington, DC: International Food Policy Research Institute (IFPRI). Retrieved from http://www.ifpri.org/sites/default/files/publications/ifpridp00860sp.pdf

Falck-Zepeda, J., Traxler, G., & Nelson, R. G. (2000). Surplus distribution from the introduction of a biotech-nology innovation. American Journal of Agricultural Economics, 82, 360–369.

Falck-Zepeda, J., Wesseler, J., & Smyth, S. (2010). The current status of the debate on socio-economic assessments andbiosafety highlighting different positions and policies in Canada and the US, the EU and Developing Countries. Paperpresented at the 2010 World Congress of Environmental and Resource Economics (WCERE) in Montreal,Canada, June 29, 2010.

GEUM. (2005, March 18). Ley de Bioseguridad de los Organismos Genéticamente Mejorados. Gobierno de losEstados Unidos Mexicanos. Retrieved from http://www.diputados.gob.mx/LeyesBiblio/pdf/Ley_BOGM.pdf

GEUM. (2008, March 19). Reglamento de la Ley de Bioseguridad de los Organismos Genéticamente Mejora-dos. Gobierno de los Estados Unidos Mexicanos. Retrieved from http://www.cibiogem.gob.mx/Norm_Leyes/Reglamento_LBOGM.pdf

GoB. (2005, November). Decree 5.591/2005, which regulates Law 11.105/2005. Government of Brazil.Retrieved from http://bch.biodiv.org/database/attachedfile.aspx?id=600

GoP. (2006, May 22). Executive order No. 514. Government of the Philippines. Retrieved from http://bch.dost.gov.ph/system/files?form_id=105.096.098.86.67.073.042.097.63.25.111.09.51.76.87.082.&file=Executive%20Order%20514%20-Establishing%20the%20NBF.pdf&loc=related_docs

GoRSA. (2007). Genetically Modified Organisms Act, 1997. Government of the Republic of South Africa. Retrievedfrom http://www.nda.agric.za/docs/geneticresources/AnnexureGMO.htm

Gouse, M., Kirsten, J., Shankar, B., & Thirtle, C. (2005). Bt cotton in KwaZulu Natal: Technological triumphbut institutional failure. AgBiotechNet, 7, 1–7.

IAEG-CGIAR. (2000). Impact Assessment of Agricultural Research: Context and State of the Art. Revised paperprepared by the Impact Assessment and Evaluation Group of Consultative Group on InternationalAgricultural Research (CGIAR) for the ASARECA/ECART/CTA Workshop on Impact Assessment ofAgricultural Research in Eastern and Central Africa, Uganda, November 1999. Retrieved from http://impact.cgiar.org/methods/docs/sofart.pdf

Intriligator, M. D. (1996). Drug evaluations: Type I vs. type II errors. UCLA Research Program in PharmaceuticalEconomics and Policy (pp. 96–92). Los Angeles, CA: UCLA.

Isaac, G. E. (2002). Agricultural biotechnology and transatlantic trade: Regulatory barriers to GM crops. Oxon, UK:CABI Publishing Inc.


Isaac, G. E. (2004). The interaction between levels of rule making in international trade and investment: The case of sanitaryand phytosanitary measures. Discussion Paper Prepared for the “Workshop on the Interaction BetweenLevels of Rule Making in International Trade and Investment UNU CRIS/LSE ITPU Project” in Brussels,Belgium, December 2004.

Jaffe, G. (2005). Implementing the Cartagena Biosafety Protocol through national biosafety regulatory systems:An analysis of key unresolved issues. Journal of Public Affairs, 5, 299–311.

Jaffe, G. (2006). Regulatory slowdown on GM crop decisions. Nature Biotech, 24, 748–749.James, C. (2008). Global status of commercialized biotech/GM crops: 2008. ISAAA brief 39. Ithaca, NY: International

Service for the Acquisition of Agri-biotech Applications.Kalatzaidonakes, N., Alston, J. M., & Bradford, K. J. (2006). Compliance costs for regulatory approval of new

biotech crops. In J. Alston, D. Zilberman, & R. Just (Eds.), Economics of regulation of agricultural biotechnolo-gies. New York: Springer Editors.

Kikulwe, E., Wesseler, J., & Falck-Zepeda, J. (2008). Introducing a genetically modified banana in Uganda: Socialbenefits, costs, and consumer perceptions. IFPRI Discussion Paper 767. Washington, DC: International FoodPolicy Research Institute (IFPRI). Retrieved from http://www.ifpri.org/pubs/dp/ifpridp00767.asp

Maredia, M., Byerlee, D., & Anderson, J. R. (2000). Ex post evaluation of economic impacts of agricultural researchprograms: A tour of good practice. In the future of impact assessment in the CGIAR: Needs, constraints and options.Rome, Italy: CGIAR Technical Advisory Committee Secretariat, FAO.

McLean, M. A., Frederick, R. J., Traynor, P. L., Cohen, J. I., & Komen, J. (2002). A conceptual framework forimplementing biosafety: Linking policy, capacity, and regulation. International Service for National AgriculturalResearch (ISNAR) Briefing Paper #47, The Hague, The Netherlands.

MoADR. (2005, December 6). Decreto 4525 por la cual se reglamenta Ley 740 del 2002. Republica de Colombia.Retrieved November 20, 2010, from http://bch.biodiv.org/database/attachedfile.aspx?id=626

Mulenga, D., & Shunwa-Mnyulwa, D. (2010). Overview of national biosafety frameworks with an emphasis on biosafetysocio-economic provisions. Presentation made at the workshop “Biosafety Socio-Economic Risk AssessmentTraining Workshop” organized by RAEIN Africa and University of Pretoria, Pretoria, South Africa,February 15–19, 2010.

Nuffield Council on Bioethics. (2003). The use of genetically modified crops in developing countries. London:Nuffield Council for Bioethics. Retrieved from http://www.nuffieldbioethics.org/go/ourwork/gmcrops/publication_313.html

OECD. (1986). Recombinant DNA Considerations—Safety considerations for industrial, agricultural and envi-ronmental applications of organisms derived by recombinant DNA techniques. Retrieved August 1, 2010,from http://www.oecd.org/dataoecd/43/34/40986855.pdf

Pray, C. E. (2010). The role of socio-economic assessment in decisions about the approval of GMOs in India,China and South Africa. Paper presented at the 2010 World Congress of Environmental and ResourceEconomics (WCERE) in Montreal, Canada, June 29, 2010.

Pray, C., Ramaswami, B., Huang, J., Bengali, P., Hu, R., & Zhang, H. (2006). Costs and enforcement of biosafetyregulation in India and China. International Journal of Technology and Globalization, 2, 137–157.

Qaim, M. (2009). The economics of genetically modified crops. Annual Review of Resource Economics, 1, 665–694.Redenbaugh, K., & McHughen, A. (2004). Regulatory challenges reduce opportunities for horticultural crops.

California Agriculture, 58(2), 106–115.SAGPyA. (2007, February 5). Resolución 60: Régimen para la Comercialización de Organismos Genéticamente Mejorados

que Contengan Eventos Acumulados. Secretaria Agricultura, Ganadería, Pesca y Alimentos, Republica deArgentina. Retrieved November 20, 2010, from http://www.sagpya.mecon.gov.ar/new/0-0/programas/conabia/Resolucion_60_2007.pdf

Smale, M. P., Zambrano, P., Gruère, G., Falck-Zepeda, J. B., Matuschke, I., Horna, D., Nagarajan, L., Yerra-mareddy, I., & Jones, H. (2009). Measuring the economic impacts of transgenic crops in developingagriculture during the first decade: Approaches, findings, and future directions. Food Policy Review 10.Washington, DC: International Food Policy Research Institute (IFPRI).

Stein, A. J., & Rodríguez-Cerezo, E. (2009). The global pipeline of new GM crops: Implications of asynchronous approvalfor international trade. Seville, Spain: European Commission, Joint Research Centre, Institute for Prospec-tive Technological Studies. Retrieved March 1, 2010, from http://ipts.jrc.ec.europa.eu/publications/pub.cfm?id=2420

Wesseler, J., & Ansink, E. (2010). How much biosafety to buy: A decision rule for additional bio-safety tests. Paperpresented at the 2010 World Congress of Environmental and Resource Economics (WCERE) in Montreal,Canada, 29 June 2010.


Documents

Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks