Falck Zepeda Socio Economic Considerations CDB 2011

171
Socio-economic Considerations in Biosafety and

Biotechnology Decision Making: The Cartagena
Protocol and National Biosafety Frameworks ropr_488 171..196
Jose Benjamin Falck-Zepeda

International Food Policy Research Institute (IFPRI)—EPTD
Patricia Zambrano
International Food Policy Research Institute (IFPRI)—EPTD
Abstract
Article 26.1 of the Cartagena Protocol on Biosafety left open the possibility for member countries to
include in their biosafety regulatory processes the assessment of socio-economic considerations. Countries
may also decide to include such assessments as part of their national legislation or regulations for the
approval and deliberate release into the environment of genetically engineered technologies. Countries are
debating if and how to implement assessment of socio-economic considerations. This paper contributes to
the 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 of
socio-economic assessments in biosafety and/or biotechnology approval processes. This paper also discusses
the implications of such inclusion for technology flows and public and private sector R&D. If inclusion
is not done properly, it may negatively impact technology flows especially from the public sector and render
an unworkable biosafety system.
KEY WORDS: genetically engineered crops, biotechnology, biosafety, socio-economics, impact assess-
ment, Cartagena Protocol on Biosafety, developing countries
Introduction
B iotechnology and its modern applications including genetically engineered (GE)

crops1 have shown great promise in addressing specific producer and consumer
constraints in developing countries. When GE technologies became feasible in the
late 1970s and early 1980s, the scientific community and policy makers faced the
need of designing and implementing protocols and procedures to ensure their
proper safety assessment. Early biosafety regulatory design was based on existing
regulatory systems in agriculture and in other sectors of the economy.
These experiences were incorporated into the 2000 Cartagena Protocol on
Biosafety,2 an implementing agreement under the Convention on Biological Diver-
sity, especially those procedures outlined in its Annex 3. The Cartagena Protocol is
primarily an international agreement formalizing biosafety assessments as a pre-
condition for GE crop approvals for transboundary movements due to trade.3 Once
the Protocol became operational in 2003, it became a major driving force for the
development of national regulatory systems and has had an impact on—in some
cases triggered the development of—public and private sector research policies and
R&D innovation management, particularly for countries Parties to the Protocol.
The main objective of the Cartagena Protocol on Biosafety is “to contribute to
ensuring an adequate level of protection in the field of the safe transfer, handling
and use of living modified organisms resulting from modern biotechnology that
may have adverse effects on the conservation and sustainable use of biological
Review of Policy Research, Volume 28, Number 2 (2011)
© 2011 by The Policy Studies Organization. All rights reserved.
172 Jose Benjamin Falck-Zepeda and Patricia Zambrano
diversity, taking also into account risks to human health, and specifically focusing on
transboundary movements” (CPB, Article 1, p. 3).
National regulatory systems in many developed and developing countries have
broadened the environmental scope of biosafety assessments as described in the
Protocol 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 the
biosafety decision-making processes. Even though a strict interpretation of Article
27.1 limits the scope of socio-economic considerations’ assessments to impacts on
biodiversity, especially with an emphasis on indigenous and local communities, the
wording of Article 27.1 opened a window for national laws and regulations to
broaden 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 under
its 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 to
the value of biological diversity to indigenous and local communities.
2. The Parties are encouraged to cooperate on research and information
exchange 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 on
Biodiversity.
Some developing and developed countries, especially those parties to the Pro-
tocol, have initiated discussions in Protocol meetings and other international policy
forums, regarding the implementation issues for the inclusion of socio-economic
consideration assessments in biosafety decision-making processes. Many countries
are now actively seeking guidance in terms of how to include these considerations
in 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 diverse
interpretations. The contribution of this article is to provide some technical and
regulatory procedural guidelines to delimit these interpretations and give some
elements 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 decisions
needed to implement socio-economic assessments (SEAs) within the context of
biosafety and/or technology decision-making processes. This article is not about the
science behind biotechnology product development, risk analysis procedures or the
state-of-the-art assessment methods for the SEA of such products; rather this paper
Socio-economics, Cartagena Protocol, and Biosafety Decision Making 173
is about the knowledge, policies, and politics behind biosafety and biotechnology
decision-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 inclusion
of socio-economic considerations assessments may have a negative impact in R&D
and innovation policies and practices in industrialized and developing economies,
affecting both the public and private research sectors who are conducting advanced
biotechnology 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 assessment
process. Third, we discuss the relationship between the Cartagena Protocol on
biosafety, 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, and
national innovation efforts. We finalize the article with some concluding comments
and 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 a
critical mass of regulatory experience in other sectors such as the pharmaceutical
and chemical industries coupled with accumulated familiarity and knowledge on
crops, 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 as
the OECD “Blue Book” (OECD, 1986). Both the Asilomar Conference—and to
quite a degree the OECD guidelines—were written mainly by scientists for scien-
tists. These documents carefully summarized all the elements of good practice for
biosafety assessments to date, based on the scientists’ accumulated experience and
familiarity with state-of-the-art research, development, and regulatory processes
familiar to them, including those in the pesticide and pharmaceutical industries.
Using this knowledge, regulators and policy makers have been able to frame the
development of modern biosafety regulatory systems within specific parameters
and guidelines, while at the same time learning valuable lessons for biosafety
assessment 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 has
technical limitations for assessing every potential risk of GE crops, and, finally,
countries have financial, institutional, and time limits to their ability of addressing
risk and risk taking. Functional biosafety regulatory systems have evolved and
matured over time not only by addressing these issues but also by weighting the
decision process with the fact that there are always trade-offs in procedures followed
and that the status quo is not necessarily risk-free (Nuffield Council on Bioethics,
2003).
While there might be an initial desire to establish stringent regulations to a new

technology as a precautionary stance toward potential risk, the accumulated expe-
rience in other regulated sectors has shown that there is an inverse relationship
between regulatory intensity and technology deployment. In other words, inflex-
ible and unnecessarily precautionary approaches to regulation will result in fewer
potentially beneficial products available to farmers and consumers. Given these
considerations, regulatory decision makers need to perform an assessment of safety
gains 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, regulatory
systems attempt to prevent the introduction of potentially harmful technologies to
the environment and public health. Second, regulators may consider the efficacy of
the regulated product. Here the regulator may be concerned with preventing the
introduction of unimportant or inefficacious technologies to society. Finally, the
robustness of any regulatory system directly relates to the public confidence on both
the regulatory process and its determinations of safety and efficacy for regulated
products. 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 biosafety
decision making one must first understand what biosafety is and how countries have
implemented biosafety assessments in practice. The Cartagena Protocol on Bio-
safety does not explicitly define the term biosafety, leaving the parties to the
Protocol 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 resulting
from biotechnology and its products.” The Biosafety Unit’s definition can be
expanded to consider those processes which have been implemented within the
scope of a regulatory system that enable a robust risk and benefit analysis of
genetically engineered crops. Biosafety then considers, in this expanded definition,
new technologies’ adoption evaluation with careful consideration of their potential
effects 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 the
importance of framing biosafety within each country’s context as well as that of
global 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 other
stakeholders’ concerns and conflicting issues deemed important by society. A func-
tional biosafety regulation system may have significant benefits for society and
should ensure that the “right” technologies make it to market, while discarding
those technologies that do not work and/or that do not meet society’s safety
standard.
Biosafety approaches use aspects derived from competing regulatory para-

digms. Some countries designed their regulatory systems so that they are learning
and knowledge management processes. This is a characteristic of regulatory
systems 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 contributing
to the assessment of most products entering the regulatory pipeline. Examples of
countries who have incorporated—to different degrees—learning and knowledge
components in their regulatory system include the United States, Canada, the
E.U., Brazil, and Mexico.
Most biosafety systems, however, tend to incorporate some prescriptive processes
having developers comply with a minimum set of activities. In most countries, a
developer will have to submit information regarding the food/feed safety profile for
the 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 include
invasiveness, 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 under
which the biosafety regulatory process functions. Even in a country where the
biosafety approval process is technically “voluntary” such as the United States, it is
unlikely that a developer will release a product without undergoing the competent
authority review due to potential liability concerns and the need to obtain a “seal
of 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’s
purview, and thus for those traits environmental biosafety assessments can be
considered mandatory. It is unclear whether other traits can be included under
such statutes. In this sense, existing biosafety processes incorporate prescriptive
procedures.
Note that what are prescribed in these assessment approaches are really the
classes of biosafety assessment (i.e., food/feed and environmental safety). A biosafety
system, however, runs the risk of becoming excessively prescriptive if it mandates
specific activities to developers in order to demonstrate that the product is safe for
food/feed or the environment. There is no country that we are aware of that
implements a completely prescriptive biosafety system. The issue we wanted to
point out is that prescriptive approaches tend to take away the flexibility for
developers and even regulators to use alternative assessment procedures that may
be 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 of
countries that incorporate political components to different degrees and use differ-
ent modalities within their decision-making process include those of the European
Necessary or sufficient Other motivations

knowledge to determine
a product as “safe”
Food/feed safety
Allergenicity
• Liability
Toxicity
Composition substantial equivalence
• Marketing
Environmental safety
Gene flow and damage
• Science and curiosity
Impact on nontargets • “Excessive” precaution
Impacts on agro-biodiversity or
biodiversity
Figure 1. Activities Conducted to Implement Biosafety Assessment Processes
Union, China, Brazil, and Mexico. A strictly “scientific” approach to regulation may
disregard issues and concerns relevant to some sectors of society, while a “socially
based” process that incorporates political issues runs the risk of special interest
groups interfering with the decision-making process with no objective justification.
Competing regulatory models further reinforce the idea that biosafety systems
respond to national needs and capacities for regulatory assessment purposes. Fur-
thermore, a regulatory system will be a reflection of pervading attitudes toward
science and decision making (Isaac, 2002, 2004). Notwithstanding the regulatory
approach, regulators and safety assessors, as well as decision makers, face the fact
that 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 eventual
deliberate release approval, while reducing as much as possible regulatory
errors.4
Proper application of scientific research and development procedures coupled
with science-based biosafety procedures have ensured, so far, a remarkable safety
record of accomplishment. To date there has not been any demonstrated damage of
any of the commercially released GE crops worldwide. Instances of purported
regulatory failures relate more to deficiencies of standard operating procedures
required for biosafety management than to the assessment process itself. Note that
this outcome is a reflection of the developers’ desire to deliver safe and effective
products, and regulatory system reducing the possibility of assessment errors.
Pursuance of greater precision and accuracy as well as the pressure from the
general public and particularly active civil society organizations has motivated some
biosafety regulatory systems to require more information than what would be
reasonable for guaranteeing a product’s safety. Information gathering beyond this
limit is not only superfluous, but expensive and it may even require additional
activities beyond those deemed as necessary and sufficient to demonstrate safety.
The motives for pursuing a very small risk level—or alternatively zero risk—are
beyond the safety assessment and might as well be guided by other concerns such
as 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).
Figure 2. Biosafety Regulatory Phases and Regulatory Decision Points
The Biosafety Assessment Process
Most biosafety regulatory processes for GE crops consist of a sequential set of steps
that require advance review and regulatory approvals by institutional, regional,
and/or national biosafety committees (see Figure 2). A typical set of sequential steps
may include laboratory trials, glasshouse/greenhouse (contained) trials, confined
field trials, step up (extended) field trials, and commercialization, although there
are variations to the sequence presented in Figure 2.
The linear sequence of events in Figure 2 considers the possibility that each step
builds upon the accumulated knowledge in previous regulatory steps and/or the
generation of additional knowledge submitted to regulatory authorities. Biosafety
regulators examine application dossiers submitted by the proponent considering
the parent crop, the transformation method, the gene construct, and the GE crop
for health and environmental impact. All these activities conducted during the
regulatory approval phase have a financial and time cost. Proponents need to input
financial biosafety regulatory costs to total development costs while society needs to
consider 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 the
inclusion 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, specific
impact parameters, and the inclusion of assessments is subject to international
obligations. The Protocol, however, leaves up to each country the discretion of
defining socio-economic considerations impacts5 and developing their own national
regulatory frameworks that may open the possibility for countries including
broader 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
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 this Focus is on a) Import decisions and/or b) Issues
Protocol or under its domestic measures implementing the included under domestic laws and regulations
Protocol,
. . . may take into account, Voluntary, it is not mandatory to consider
Socio-Economic Considerations
. . . consistent with their international obligations, Especially with World Trade Organizations (WTO)
. . . socio-economic considerations arising from the impact Strictly a narrow scope on environmental issues.
of living modified organisms on the conservation and
sustainable use of biological diversity,
. . . especially with regard to the value of biological diversity Text seems to direct parties to a suggested impact
to indigenous and local communities. parameter and assessment focus
like proposing assumptions, models, and uncertainties—or the lack of sufficient or

accurate data—socio-economic impact assessment incorporates a significant share
of 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 considerations
in the biosafety decision-making process, the first step that needs to be defined is
the purpose and objective for inclusion and most importantly the time when the
assessment will be done. An impact assessment during the biosafety regulatory
assessment 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 standard
technology 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-economic
considerations implies an additional regulatory hurdle that may have a negative
impact in terms of time or lost opportunity on the access to new technologies. To
reduce 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, inclusion
of socio-economic considerations raises a question regarding who are the best
qualified people to make a decision about a specific technology with convincing
arguments. Are they academics, government officials, regulators, consumers, or
farmers? We discuss the latter question in the biosafety and socio-economic politics
section of this article.
Although the issues and questions posed previously are quite important, a more
basic question to answer is whether a robust regulatory system should include
socio-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 question
of what will be achieved in terms of societal welfare gains from the inclusion of
socio-economic considerations into biosafety and biotechnology decision making.
To date, most biosafety systems have focused only on safety, and there are only a
few countries that have included socio-economic impacts in their legislation. The
Table 2. Biosafety Decision and Outcome Matrix
Regulatory body action
Approve new biotechnology Do not approve new biotechnology

State of Nature Biotechnology safe Correct Incorrect
Biotechnology not safe Incorrect Correct
Adapted from Intriligator (1996).
few examples include Argentina on trade, and the European Union on periodic
post-approval socio-economic impacts, although there is very little clarity on how
inclusion is likely to be implemented in the latter case. There are nevertheless many
countries that have indicated their plans to include socio-economic considerations
in 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 contrastingly
diverse biotechnology innovation development and biosafety capacity including
Malawi, Namibia, South Africa, Swaziland, Zambia, Zimbabwe, and others. These
same studies, however, confirm that despite this growing interest very few countries
have 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 more
solid regulatory process is yet to be assessed in the specific context of individual
developing countries. Assessing the robustness of socio-economic considerations
inclusion has to consider that biosafety regulatory systems, as with any decision
making process, may render outcomes that are either correct or incorrect. This
decision contrasts with the actual state of nature of regulated products that are
either safe or unsafe. Combinations of these four parameters render two outcomes
that 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 the
possibility of not approving a safe technology. Inclusion of socio-economic consid-
erations complicates decision based on these biosafety regulatory outcomes by
introducing 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 is
whether harmful/ineffective technologies are the only ones excluded by regulations.
The answer to this question is that regulatory systems have not approved in the past
safe and effective technologies and thus society has lost with this type of regulatory
error.7 With the inclusion of socio-economics, society may face indeed the potential
of having a regulatory outcome where there may be robust and positive biosafety
assessment coupled with a weak but negative SEA. The question then becomes what
will 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 and
who may consider inclusion of SEAs into biosafety and/or biotechnology decision
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 monitoring
situation is likely to face similar issues.
Definition and Scope
The procedure for inclusion of socio-economic considerations must first define

what socio-economic considerations are and thus also define whether the standard
or operating procedure will follow a strict interpretation of Article 26.1 of the
Cartagena Protocol or will consider a broader mandate under national regulations.
Implementing regulations need to define whether to include socio-economic issues
only, or if they should be broadened to include, as some stakeholders appear to
suggest, ethical, philosophical, or religious considerations.
Examples of national and regional legislations requiring the inclusion of issues
beyond socio-economic considerations are Executive Order 514 in the Philippines
(GoP, 2006), 2006 GMO Amendment Act 23 of South Africa (GoRSA, 2007) and the
African 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 they
may 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, methods
to be used for the evaluation, and certainly the cost of implementing such
regulations. At the same time, regulatory systems need to define method feasibility
especially for ex ante evaluations as the assessment of products that have not yet been
adopted has limited data and thus have to be based on a set of many subjective
assumptions. For example, SEA practitioners can describe the potential ethical,
religious, and philosophical impacts from the adoption of a GE crop by using
qualitative and participatory approaches for evaluation. Requesting a quantitative
measurement of these same issues in an ex ante framework can be futile for imple-
mentation in practice. Furthermore, incorporating results from broader-type
assessments to regulatory processes might be hard to accomplish for decision
making as it incorporates subjective values, difficult to incorporate in a biosafety
assessment.
In addition to the definition of what socio-economic considerations to include in
the assessment, implementation regulations need to define whether inclusion of
SEAs is mandatory (i.e., required by national regulations or procedures) or volun-
tary for an application. Mandatory requirements without clear decision-making
processes and standards may lead to an unworkable system as decisions may be
taken upon a subjective decision-making framework and in some cases subject to
special-interest-group pressures. In the case of voluntary procedures, with or
without clear decision-making processes and standards, developers may not deem
it important to conduct such studies and thus deprive society of much-needed
information 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 comply

with this requirement seems reasonable. If the comparison is done with a country
where there have been socio-economic studies but where there has not been clarity
in terms of how they were used for decision making (for examples from India and
to some degree China, see Pray, 2010), one can begin seeing that either the
socio-economic did not contribute much to decision making—thus a waste of
valuable resources—or it introduces more complexity into a system, while not
necessarily guaranteeing a better regulatory outcome.
Timing—When to Require SEA?
Inclusion protocols need to define when is the appropriate stage for the proponent
to include socio-economic considerations assessment for review by the regulatory
body. In those systems where inclusion is mandatory, policy makers need to raise
several questions. Will inclusion procedures require (or consider) socio-economic
considerations during laboratory/greenhouse, confined or multi-locational field
trials, or during commercialization applications? Will the biosafety system consider
only those assessments after deliberate or general release? For example, can an SEA
can be considered a requirement for renovating temporary commercialization
permits customarily given to proponents in most countries as done by the European
Union?
As the technology progresses through the regulatory pipeline, developers may
gather additional information regarding the field performance—although in most
cases practitioners have to be cautious with the interpretation as it is experimental
data—of the technology and thus it may be worthwhile to wait for later stages of the
regulatory process.
An important consideration for society is that spending scarce resources on
products that the developer will not release is a waste of money and resources.
Therefore, inclusion protocols that require SEAs from laboratory through confined
field trials are quite unjustified as many of the products will not survive the
evaluation process. Certainly, requesting a socio-economic study for the commer-
cialization application process can be justifiable in terms of resource utilization. The
desirability of holding the requirement of a socio-economic study until the com-
mercialization approval process (general/deliberate release) has to be included in
the 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 the
current approach followed both in the United States and Canada. The regulatory
system relies only on the scientific risk assessment for approvals of confined field
trials and general/deliberate release. The rationale behind this alternative is that
developers screen the technologies for efficacy, regulators for safety, while farmers
decide which technology is best for their context.
Certainly, the possibility exists that developers may volunteer a SEA as part of
the application dossier, but in this regulatory option, it is not mandatory for the
developer to include such assessment or for the regulatory bodies to consider the
assessment itself. Falck-Zepeda and others’ (2010) argument is that the noninclusion
in these countries is a consequence of having a strong judicial system that resolves
any 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 decision
makers do with the information generated by the assessment. For example, if a
socio-economic assessment renders a negative evaluation where the technology
performance is directly influenced by institutional constraints, not by the technol-
ogy proficiency, would the decision-making outcome be to reject the technology? If
this is so, then decision makers may be penalizing the assessed technology unduly
when 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 positive
but highly variable distribution of outcomes? Some of these outcomes perhaps
imply a “riskier” production process but with high income possibilities for farmers,
thus becoming a decision-making-under-risk process, which many countries may
not be prepared to undertake at this time.
Even when conducting a robust assessment, SEAs continue to incorporate more
aspects of art in an approach that uses scientific tools and methods. Thus estimates
from SEAs can vary significantly. Different assessors can provide different—maybe
conflicting—SEAs, even when applying robust assessments methods. If the main
stakeholders, farmers, and consumers are the ones who will endure both the
consequences of right and wrong regulatory decisions, it strengthens the argument
for these stakeholders to be the ones who actually make the adoption and use
decisions. 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 process
option, a technology decision-making entity commissions or conducts both assess-
ments and renders a decision. This option has the benefit of potentially reducing
time delays and limiting the influence of politics (as opposed to fact gathering) in
the assessment process. Examples of countries that have implemented this
approach 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 concurrent
approach, this option isolates the risk assessment from politics while leaving the
option open of considering politics in the technology decision-making process. At
the same time this approach poses the risk of unnecessarily delaying the approval
process.
An example of a country that follows this approach is Argentina, although the
SEA there only considers impacts of the potential adoption on trade, specifically the
competitiveness of Argentinean exports. The case of Argentina is quite instructive as

it provides an example of an evaluation process that has a relatively well defined
trigger 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 being
defined process with relatively clear decision making standards.
A variation of this option is the approach followed by the European Union that
now seems to require a post-release monitoring for those temporary approvals for
commercialization purposes. In contrast to the Argentinean example there is very
little guidance in the EU process in terms of scope, evaluation methods, and
decision-making rules and standards. Within the EU, the Netherlands through its
Commission on Genetic Modifications (COGEM, 2009) published in 2009 a report
on 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 Safety
Authority and the European Commission for the approval of GM crops and now
has 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 by
the competent EU level authority. Whether this development implies that each EU
country now has the ability of conducting socio-economic studies to back up their
decision 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 the
same time as the SEA, perhaps by the same regulatory agency. Depending on the
biosafety regulatory process outlined by a country’s specific regulations, the socio-
economic and/or biosafety assessment may be done by different assessors, including
full-time staff within the regulatory authority, third-party assessors, or the propo-
nent. There is no strict separation between this option and the concurrent but
separate option described previously. The difference lies only in the fact that the
implementing agency conducts both assessments, which poses a risk that this
authority might have further difficulty in advancing the process given the multiple
objectives it would be pursuing, and possibly facing potentially conflicting methods
on how it should carry this process. Although this is a valid option for implementing
SEAs, 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 to
be 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 assessment
will largely depend on the design of the remainder of the biosafety regulatory
system. As McLean and others (2002) points out, each one of the options to build a
regulatory system structure have trade-offs in terms of resources and capacities and
will directly relate to the country’s inventory of national capacities, the complexity
of technologies being reviewed, and the volume of regulated technologies under
review.
Each entity choice has advantages and disadvantages. For example, when a
country’s regulation opts to accept the proponent’s submission for a socio-economic
study, it will take advantage of the proponent’s familiarity and access to all the
potential information available that they generate. On the other hand, the main
disadvantage would be potential conflicts of interest and credibility as questions can
be raised in terms of the objectiveness and bias in a study conducted by the
proponent. In contrast, when the socio-economic study is commissioned to a third
party—including expert consultants, academics, or professional assessors, perhaps
within the regulatory system—the issue of bias and conflicts of interest would likely
be eliminated, but then the insufficient access to all information generated by the
developer 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-Zepeda
and others (2010) have described these options in implementing countries. For
example, the competent authority in India, the Genetic Engineering Approval
Committee, commissioned external consultants to carry out economic assessments
on two existing technologies under review by the regulatory system, although the
existing law does not require specifically a SEA. The legislation and/or national
regulations in Mexico (GEUM, 2005, 2008), Colombia (MoADR, 2005), and Brazil
(GoB, 2005), provide the competent authorities with the flexibility of choosing who
will perform the SEA study and what type of socio-economic issues to explore.
Competent authorities in Argentina don’t have such flexibility as regulations require
that the SEA study performed to be implemented by a government agency under the
Ministry 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 a
third party that assesses the validity of the proponent’s study in a peer review
approach. The third party assessor will need to have the power of requesting any
background and substantive information related to the methods, data and estima-
tion procedures, and assumptions from the developer in order to perform the peer
review. This can help clarify the assessment while empowering the third party
assessor in its evaluator mandate.
The Methods—How?
The timing of a SEA will largely drive the choice of methods that may be available
to practitioners. Data and information availability, as well as the research questions
and hypotheses to answer or test, will define the type of methods that practitioners
may use for SEAs. Table 3 considers a partial list of methods that may be available
for ex ante or ex post assessments. Ex ante assessments will be largely used during the
biosafety regulatory approval for decision-making purposes. In contrast, ex post
methods will be used for post-release monitoring, for example in the case of
products given temporary regulatory permit pending further monitoring or in the
case of conventional technology assessment procedures.
As described by Smale and others (2009), ex post evaluations assessors may need
to use multiple methodological approaches to address multiple research questions
Table 3. Social and Economic Methods Used in Ex Ante and Ex Post Evaluations
For post-release monitoring or technology evaluation

For regulatory approval purposes (ex ante) purposes (ex post)
• Partial budget and stochastic partial budget • All ex ante methods plus: Econometric / statistical
• Cost/Benefit, Net Present Value and Internal Rate of models including:
Return 䊊 Instrumental Variables and Treatment models
• Economic surplus and partial equilibrium trade models 䊊 Production and damage abatement models
• Computable General Equilibrium Models 䊊 Production risk models
• Linear and dynamic programming models 䊊 Heckman two-step models
• Simulation models • Programming models

• Real Options Models • Simulation models
• Social Accounting Matrixes • Rapid Rural Development Appraisal
• Social Network Assessments
• Gender and Generational Assessments
• Poverty and Social Impact Assessment
• Social Relevance Analysis
• Demographic and Systemic Relevance Analysis
Notes: (1) This is not an exhaustive list especially for the ex post methods. We are trying to reflect the range of methods
used for socio-economic assessments. (2) Ex ante methods need to consider the fact that there is no adoption in place
and thus rely on assumptions and/or baseline data that may allow projecting potential impacts on data. Practitioners
face this major limitation in practice.
but also to untangle many of the sampling and statistical biases that arise during
adoption. Furthermore, practitioners will probably need to conduct assessments
during multiple years to capture production variability and responses to abiotic and
biotic constraints. The choice of methods will hinge on the data availability and
assessment resources and capacities.
Each one of the methods listed in Table 3 has specific data requirements and thus
vary in terms of feasibility. For example, econometric/statistical adoption models
require actual data and thus are of limited use for ex ante assessments. Certainly, the
scope exists for using econometric/statistical methods for ex post assessments, where
the limitation is the time and resources to collect the adequate volume of data. If the
purpose of the SEA is to evaluate adoption and technology impact ex post, then
practitioners can follow the elements of best practice and lessons learned from
accumulated 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 be
performed, the regulatory system needs to establish decision-making rules and
standards so that proponents, assessors, and regulators are clear in terms of how the
decision will be made. The least desirable regulatory system outcome is having a
process 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 in
biosafety regulatory frameworks. This implies setting elements of best practice not
only for conducting the assessment but also for decision making. The standard and
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 of
the biosafety regulatory process. Specifically, all stakeholders need to know in
advance 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 criteria
including the standard for evidence, quality, and sufficiency (Falck-Zepeda, 2009).
Any socio-economic or biosafety assessment that only considers risks and not the
technology’s potential benefits will indeed penalize the technology regardless of its
merits. The assessment may render a product safe by evaluating likelihood or
probability of occurrence and damage by deeming these factors as negligible or
manageable. If the assessment does not consider potential benefits or costs to
society, then society is facing incomplete information about the technology and thus
has an increased potential of rendering a wrong decision.
Furthermore, the decision-making standard and assessment procedure need to
be feasible and cost effective, while ensuring that the overall process is protective
and efficient (Jaffe, 2006). This implies that regulators and policy makers need to
conduct periodical Regulatory Impact Assessment reviews, which may help stream-
line the process. Finally, as mentioned in the discussion of Article 26.1, inclusion of
socio-economic considerations in national frameworks and biosafety regulations
need to consider its compliance with binding international treaties especially the
World Trade Organization. This is extremely important as countries need to avoid
being liable to violations to the terms of signed international agreements. Further
discussions with regard to the relationship between biosafety and WTO can be
found in Falck-Zepeda (2009).
Assessment Triggers
An important issue to consider is whether the regulatory system would require a

SEA for each submission or alternatively consider other possibilities such as requir-
ing such assessments based on whether the proposed technology is considered a
new event, that is, a new and very specific crop and gene construct combination that
confers a specific trait to the receiving organism. If the requirement is to require a
new SEA for each submission, and thus there is no major change in the specific
assessed technology, then such requirement will result in redundant studies being
done, which are likely to be a waste of resources. If an alternative is pursued such
as requiring a socio-economic study only for new events or even allowing reference
to previous studies of the same technology, then this is usually a preferred option
from the standpoint of regulatory efficiency and for being a more cost-effective
option.
Integrating Biosafety/Biotechnology Technical Issues with Socio-economics
This is perhaps one of the most contentious and difficult issue to resolve from a
regulatory standpoint. As seen in Figure 3 regulatory decision-making needs to
consider inputs and methods from different disciplines. A typical application
dossier for commercialization approval will have information on environmental,
• Likelihood of occurrence
• Introgression into population
Decision making • Persistence
• Damage or benefits from gene
flow occurring
Gene flow • Impact on biodiversity—some
people argue that “just the fact
assessment that gene flow happens is enough”
• Economic surplus
• Cost/Benefit ratios
•Profit
Impact on Socio - • Gender and age differentiated
nontargets economics impacts
• Adoption determinants
• Labor impacts
• Productivity and production
changes
Food safety
• Digestibility
• Allergenicity
• Acute toxicity
• Substantial equivalence and
composition changes
Figure 3. Biosafety Decision-Making Issues
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 considerations
of their own. In its review, a regulator will need to consider a set of potential risk
issues and formulate a decision, which balances all considerations. It is important to
underline the fact that much of the environmental and food safety assessments are
expressed as likelihoods or probabilities of occurrence, and thus the possibility
exists 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 the
specific case of a sequential approach, the GE technology undergoes the biosafety
assessment first and if needed or required the SEA. This means that the technology
is deemed safer for deliberate release before exploring the socio-economic impli-
cations derived from deliberate release. This option has the additional advantage
that 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 New

Products 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
the number of technologies that may be released to farmers and consumers after
regulatory 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 on
how the decision making will be implemented. Alternatively, excessively compli-
cated rules and regulations for socio-economic inclusion that demand complicated
assessments that may not be even feasible, especially ex ante, will achieve the same
regulatory 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 that
will increase costs of compliance with biosafety regulations. Furthermore, depend-
ing on the timing and scope, inclusion of SEAs may increase the time needed for
completion of a biosafety regulatory assessment. There are a few studies that have
documented the cost of compliance with biosafety regulations. For example,
Kalatzaidonakes, Alston, and Bradford (2006) report a range of costs for a selected
set 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 $6.2
million for herbicide-tolerant corn. An article by Redenbaugh and McHughen
(2004) indicates that cost of compliance with biosafety regulations for horticultural
crops 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) cite
examples from an expert consultation held at the International Service for National
Agricultural Research in the Netherlands in 2002. Compliance costs varied from
$700,000 for transgenic papaya in Brazil, to $2.25 million for transgenic rice in
Costa Rica, and $4.0 million for transgenic soybeans in Brazil. The amounts
invested in complying with biosafety regulations vary significantly between coun-
tries but are directly related to the number of activities performed. Highest costs are
associated 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 the
regulatory process. The authors evaluate, for example, that increasing cost of
compliance with biosafety regulations by 400% will have a very small effect in
decreasing the net present value (NPV) of four GE technologies for release in the
Philippines. However, relatively short delays of even 1–3 years, do significantly
reduce the NPV for the same technologies.
Based on these experiences, we argue that the impact of socio-economic studies
lie not on their cost but on the possibility of introducing time binding lags to the
process—Pray et al. (2006) estimate that in India, SEA studies are in the range of
US$15,000–30,000—which is low compared with other safety assessments cost. In
contrast, a paper by Kikulwe, Wesseler, and Falck-Zepeda (2008) shows that delay-
ing the approval of a fungal-resistant banana in Uganda costs its producers
approximately US$179 million to US$365 million annually. This is especially
important for Uganda, as bananas are a staple crop in the country thus having a
definitive 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 the
regulatory systems will be unable to release valuable and safe technologies to
farmers. In addition, higher compliance costs may translate into higher social
and/or private rates of return for regulated products and thus penalize public good
technologies. This may of particular interest for developing countries who may
have crops and traits of strategic interest due to their high social and economic
value, but where there is very little regulatory experience elsewhere and where
public 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 costs
may force public research to invest more on nonregulated approaches. As cited in
Falck-Zepeda et al. (2009), this may be happening already in Brazil and other
countries. In the case of public goods, the higher costs will impact directly who will
pay for development costs. As R&D cost increase, the national research systems are
less likely to be able to afford investments in regulated technologies. In turn, an
increase in development cost might push the private sector to direct their research
efforts to products with higher “private” returns.
James (2008) has documented an expansion in the adoption over time of GE
crops 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 and
traits developed by the private sector, can be explained in part by the high and
increasing cost of compliance with biosafety regulations. The private sector has
significantly higher financial capacity to pay for these costs compared with the
public sector in developing economies that operates under much limited financial
restrictions.
The R&D pipeline is expanding although the number of products that will be
available 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 for
specific needs of nonindustrialized countries,
The cost of socio-economic considerations is important especially for public sector
organizations creating GE products in developing countries. Introduction of regu-
latory delays in the regulatory process are even more important. It is important to
underline the fact that implementation of the Cartagena Protocol focuses on risk, in
spite of its introductory statements seeking the rational and careful use of these—
potentially valuable—technologies especially in developing countries. This is a major
issue, 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 the
inclusion of SEAs into the decision-making process as assessors will be mandated to
consider positive and negative outcomes derived from benefits and costs.
Entry Barriers and Regulatory Uncertainty
Inclusion of socio-economic considerations may render a biosafety regulatory

process a nonfunctional process if it becomes an insurmountable regulatory hurdle.
This is especially true if regulations, regulators, or the biosafety assessment process

require activities beyond those needed to demonstrate a socio-economic impact
based on the decision-making standard. This may be a result of inclusion of political
processes that may cloud the assessment process by requiring answers to questions
which may not be even feasible answering in an ex ante regulatory framework. In
both situations, where socio-economic considerations increase the cost and time to
complete a regulatory assessment process, this may constitute a barrier to entry for
smaller organizations and the public sector as they may be less capable of complying
with 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 necessary
to have expertise with socio-economic methods and approaches, but it requires
knowledge of the bio-physical sciences and the regulatory considerations that are
relevant to the assessment. Furthermore, GE crops add a series of challenges that
are not typical in the assessment of other agricultural innovations, such as intellec-
tual property protection and imperfectly competitive input markets, differentiated
markets, institutional limitations, and the fact that they are knowledge technologies
(Falck-Zepeda, Traxler, & Nelson, 2000; Smale et al., 2009). The methods and
approaches need to reflect the increased complexity that these technologies face for
adoption and use. The experts needed to evaluate GE crops will need to address
this complexity especially for those assessments done in ex ante frameworks as there
is 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 SEAs
and one that will require the support provided to developing countries without
such capacity in the near future.
Policy Options for SEAs’ Inclusion

Although the Cartagena Protocol on Biosafety does not mandate inclusion of
socio-economic considerations in its decision making, it leaves the option for coun-
tries to include such option under national legislation. Policy and decision makers
in 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 potential
gains in knowledge and information that a socio-economic study can provide to
society before deciding on whether to include socio-economic considerations into
the decision-making process.
Given the complexities of the analysis and uncertainty and insufficient data that
that ex ante SEAs have to be based on, the inclusion of such assessments may add
unnecessary and costly delays to the regulatory process that are difficult justify. Not
having a mandatory inclusion of SEA in the biosafety process is certainly the
simplest and easiest option for decision makers in developing and developed coun-
tries particularly when there is a long history and accumulated experience behind
biosafety regulatory implementation.
If after a careful assessment, however, a country decides that it still wants to

include socio-economic considerations into its decision-making process, in spite of
the many binding constraints for implementation, then it would be necessary for the
country 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 in
terms of timing of evaluations, methods, scope, and the decision-making process
that will be followed by all stakeholders involved. The worst possible option is to
have an open-ended process where there is no clarity on how to conduct a SEA
study, nor how the regulatory or technology decision-making body may conduct or
commission the assessment and contrast its results with the results of the biosafety
risk assessment. The latter lends itself to too much inconsistencies, speculation, and
lack of transparency that can be questioned by all stakeholders involved in the
process, especially when the decision-making process unduly punishes a specific
technology for institutional and/or governance issues that have nothing to do with
the performance of the technology itself.
As described previously, the question to answer is what will a regulator or
technology decision maker do with the information contained in a socio-economic
study? If the results of the study indicate that society may face the situation of a
product that is—or has the potential to be—a “technological triumph but an
institutional failure” (Gouse, Kirsten, Shankar, & Thirtle, 2005), does the regulator
or technology decision maker reject the release of the technology? Should its
decision be that the institutional limitations need to be addressed before releasing
the technology? Will this regulatory or technology decision outcome have any
impact whatsoever on actually resolving the institutional limitations and who or
what institutions will be the ones called to resolve such issue? Developing countries
need to clearly provide answers to these questions so that the debates in terms of the
merits from the inclusion of SEAs can be clearly defined upfront.
We argue here that predicating the approval of a technology on institutional
issues is indeed unduly penalizing the technology itself. Unduly penalizing the
technology for factors external to its performance or safety can be magnified
especially when taking into consideration the uncertainties surrounding even
state-of-the-art robust SEAs. This line of argumentation becomes a primary reason
to choose the simplest option of not having a mandatory inclusion of socio-
economic considerations that countries may chose to consider in their decision
making.
Concluding Comments
Socio-economic considerations need to be assessed within clearly defined standards
and guidelines including methods, timelines, decision-making standards vis-à-vis
risk assessments. If socio-economic considerations are done within these standards
they 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 not
clearly define the inclusion of socio-economic considerations or such considerations
become an insurmountable hurdle, the result will be the reduction of potentially
valuable technologies to farmers and consumers. Unreasonable regulatory delays or

uncertainty can affect negatively the stream of societal benefits derived from the
adoption of GE crops as developers tend to invest less in such environments or shift
to nonregulated technologies. This outcome has to be weighed against the potential
damage from those technologies that are indeed harmful and regulatory approval
errors with positive and negative impacts.
Inclusion of socio-economic considerations in a biosafety assessment in any of
the modalities discussed in the paper, especially when the process does not clearly
define 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 latter
development 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 to
cover additional regulatory burdens beyond those necessary for the biosafety
assessment.
Finally, policy makers need to address the issue of regulatory predictability.
Regulatory uncertainty can become a disincentive for R&D investments. In this
scenario, the public sector or those interested in developing technologies with a
public good nature are likely to be impacted more than technologies with a private
nature. Furthermore, impact of regulatory uncertainty on R&D and tech transfer
investments will be critical for future technologies not only GE crops but for other
technologies in the agricultural research pipeline.
Acknowledgments
The authors would like to thank the member of the RAEIN-Africa Network, especially
Doreen Mnyulwa, Marnus Gouse, Abisai Mafa, Margaret Sikwese, Elrod Naomab, Dorothy
Mulenga, 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 activities
implemented within the Program for Biosafety Systems at the International Food Policy
Institute. 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 Canada
who made this paper possible. The opinions expressed herein are those of the authors
and do not necessarily reflect the views of the U.S. Agency for International Development
or IDRC. However, all the responsibility of the content of this paper lies solely in the
authors.
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 expressed
in one or more tissues, and is inherited by offspring in a Mendelian fashion.” However, future
products may not be transgenic at all. In this article, we use the generic term for the process used to
derive the product, that is, genetic engineering or modifications.
2 The Conference of the Parties to the Convention Biological Diversity adopted The Cartagena Protocol
on 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 not
submitted ratification instruments but who may participate as nonparties in the Cartagena Protocol
discussions (see http://www.cbd.int/biosafety/signinglist.shtml).
3 One of the reviewers of this paper noted that the international biosafety protocols do not necessarily
ensure 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 likely
deliver a safe product. There is a high degree of confidence in the R&D process that unsafe or
ineffective 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 reputation
and avoiding liability. This outcome is likely to hold in spite of the existence of formal biosafety
protocols. What a protocol document such as the Cartagena Protocol does is to formalize a regulatory
process, 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 much
guidance for implementation.
4 This fact directly contrasts with strict interpretations of the precautionary approach contained in the
Cartagena Protocol on Biosafety, which require ensuring zero risk, which implies demonstrating
impossibility.
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 and
environmental 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 involve
changes 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), in
terms of its relevance, effectiveness, efficiency, and impact.” In general, economics would focus with
pecuniary (and nonpecuniary) costs and benefits. In contrast, sociology, anthropology, or political
sciences 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 to
increased 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. Reasons
given by respondents for the noninclusion of socio-economic considerations into GMO decision
making include issues such as not required by regulations, no implementation mechanisms
available, political reasons, lack of institutional capacity, and others. A summary of preliminary
results 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” standard
and a set of decision-making rules. Furthermore, regulatory systems can commit regulatory errors. In
the end, regulatory systems need to conduct a regulatory cost/benefit analysis of potential biosafety
regulations by answering the question of whether to undertake regulatory actions that are also costly
to undo over time. This analysis should consider the potential gains in knowledge from additional
experimentation 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 policy
and technological innovation in developing countries. He earned his M.Sc. and Ph.D. from
Auburn University, Alabama.
Patricia Zambrano is a senior research analyst at the International Food Policy Research
Institute. Her work focuses on the evaluation of pro-poor crop biotechnologies and the
economics of biosafety regulations programs. She earned a master’s degree in economics
from the University of California, Davis.
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171

Socio-economic Considerations in Biosafety and

Jose Benjamin Falck-Zepeda

B iotechnology and its modern applications including genetically engineered (GE)

Box 1. Article 26 of the Cartagena Protocol on Biosafety

Biosafety and SEAs

Why Regulate GE Technologies?

While there might be an initial desire to establish stringent regulations to a new

What Is Biosafety Anyway?

Biosafety approaches use aspects derived from competing regulatory para-

Biosafety Regulatory Approaches

Necessary or sufficient Other motivations

Figure 1. Activities Conducted to Implement Biosafety Assessment Processes

Figure 2. Biosafety Regulatory Phases and Regulatory Decision Points

The Biosafety Assessment Process

Socio-economic Considerations and the Cartagena Protocol

Text of article 26.1 of the Cartagena Protocol on Biosafety Comments

like proposing assumptions, models, and uncertainties—or the lack of sufficient or

Table 2. Biosafety Decision and Outcome Matrix

Regulatory body action

Approve new biotechnology Do not approve new biotechnology

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

Definition and Scope

The procedure for inclusion of socio-economic considerations must first define

decision standards—system such as Argentina, the level of effort needed to comply

Timing—When to Require SEA?

Implementation Modalities of the Socio-Economic Inclusion Process

Countries have several options on how to implement the inclusion of socio-

No Mandatory Inclusion—The first option is no inclusion of socio-economic consid-

Sequential—A third option is a sequential approach where proponents or profes-

competitiveness of Argentinean exports. The case of Argentina is quite instructive as

For post-release monitoring or technology evaluation

• Computable General Equilibrium Models 䊊 Production risk models

• Linear and dynamic programming models 䊊 Heckman two-step models

• Simulation models • Programming models

Decision-Making Rules and Standards

The biosafety regulatory framework needs to define clearly methods, decision-

decision-making process needs to be transparent and predictable so that partici-

An important issue to consider is whether the regulatory system would require a

Integrating Biosafety/Biotechnology Technical Issues with Socio-economics

Figure 3. Biosafety Decision-Making Issues

food/feed safety, and perhaps socio-economic impacts and other considerations.

Implications Derived from Inclusion of Socio-economics

Compliance with Regulatory Regimes and a Reduction in the Number of New

The possibility of noncompliance with biosafety regulations increases when a bio-

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

Entry Barriers and Regulatory Uncertainty

Inclusion of socio-economic considerations may render a biosafety regulatory

This is especially true if regulations, regulators, or the biosafety assessment process

Human and Financial Capacity Requirements for Assessments

Policy Options for SEAs’ Inclusion

If after a careful assessment, however, a country decides that it still wants to

valuable technologies to farmers and consumers. Unreasonable regulatory delays or

About the Authors

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