GM Crops & Food

Biotechnology in Agriculture and the Food Chain

ISSN: 2164-5698 (Print) 2164-5701 (Online) Journal homepage: https://www.tandfonline.com/loi/kgmc20

The emerging international regulatory framework

for biotechnology

John Komen

To cite this article: John Komen (2012) The emerging international regulatory framework for
biotechnology, GM Crops & Food, 3:1, 78-84, DOI: 10.4161/gmcr.19363

To link to this article: https://doi.org/10.4161/gmcr.19363

Published online: 01 Jan 2012.

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GM Crops and Food: Biotechnology in Agriculture and the Food Chain 3:1, 78–84; January/February/March 2012; G 2012 Landes Bioscience

The emerging international regulatory framework

for biotechnology
John Komen
Assistant Director; Program for Biosafety Systems; International Food Policy Research Institute; Haarlem, The Netherlands

Keywords: biotechnology, GMO, policy, regulation, biosafety, Cartagena Protocol on Biosafety, World Trade Organization

Abbreviations: AIA, Advance Informed Agreement; ASEAN, Association of South East Asian Nations; BCH, Biosafety Clearing-
House; CARICOM, Caribbean Community; CBD, Convention on Biological Diversity; COMESA, Common Market for East and
Southern Africa; CPB, Cartagena Protocol on Biosafety; DNA, deoxyribonucleic acid; FAO, Food and Agriculture Organization of the
United Nations; GEF, Global Environment Facility; GMO, genetically modified organism; GM, genetically modified; ICPM, IPPC
Commission on Phytosanitary Measures; IPPC, International Plant Protection Convention; ITPGRFA, International Treaty on Plant
Genetic Resources for Food and Agriculture; LMO, living modified organism; LMO-FFP, LMOs intended for direct use as food
or feed or for processing; MOP, Meeting of Parties; NBF, national biosafety framework; OECD, Organisation for Economic
Co-operation and Development; OIE, Office International des Epizooties (World Organization for Animal Health); SPS, Agreement
on Sanitary and Phytosanitary Standards; TBT, Agreement on Technical Barriers to Trade; TRIPs, Agreement on Trade-Related
Aspects of Intellectual Property Rights; UPOV, International Union for the Protection of New Varieties of Plants; WAEMU, West
African Economic and Monetary Union; WHO, World Health Organization; WTO, World Trade Organization

© 2012 Landes Bioscience.

Debate about the potential risks of genetically modified organisms (GMOs) to the environment or human health spurred
attention to biosafety. Biosafety is associated with the safe use of GMOs and, more generally, with the introduction of
non-indigenous species into natural or managed ecosystems. Biosafety regulation—the policies and procedures adopted

Do not distribute.
to ensure the environmentally safe application of modern biotechnology—has been extensively discussed at various
national and international forums. Much of the discussion has focused on developing guidelines, appropriate legal
frameworks and, at the international level, a legally binding international biosafety protocol—the Cartagena Protocol on
Biosafety. The Protocol is one among various international instruments and treaties that regulate specific aspects relevant
to agricultural biotechnology. The present article presents the main international instruments relevant to biosafety
regulation, and their key provisions. While international agreements and standards provide important guidance, they
leave significant room for interpretation, and flexibility for countries implementing them. Implementation of biosafety at
the national level has proven to be a major challenge, particularly in developing countries, and consequently the actual
functioning of the international regulatory framework for biotechnology is still in a state of flux.

Introduction: The International Context
for Biotechnology Regulation
Biotechnology has become an important and integral tool for
research aimed at increasing the efficiency and sustainability of
agriculture and food production. However, as with other new
technologies, its technical, social and economic implications have
created societal concerns. Regulatory systems are one way for
society to find a balance among the potential benefits, risks, and
concerns emanating from biotechnologies.
Compliance with regulatory review procedures has by now
become an essential element in the research, development and
product deployment strategies of public- and private-sector
technology developers. Obtaining regulatory approvals, among
other factors, is central to progress in agricultural technology
development and deployment. International agreements and
harmonized standards could provide guidance and facilitate
regulatory review by national authorities.
It is important to consider the emerging international frame-
work for biosafety and food/feed safety as part of a broader
emerging and expanding international regime regulating the
access and use of technology and genetic resources for food and
agriculture. This broader international regime affects the deve-
lopment and deployment of new agricultural technologies by
regulating, and sometimes restricting, access to essential research
inputs (genetic resources, proprietary technology) and the release
of research outputs such as genetically modified (GM) varieties.
As described in more detail in Komen and Salazar (2011),1
several international instruments and treaties regulate specific
aspects relevant to agricultural biotechnology. Such instruments

Correspondence to: John Komen; Email: jce.komen@planet.nl

Submitted: 07/21/11; Revised: 12/07/11; Accepted: 01/13/12
http://dx.doi.org/10.4161/gmcr.19363

78 GM Crops and Food: Biotechnology in Agriculture and the Food Chain Volume 3 Issue 1

address issues relating to three aspects that are relevant to the
development of agricultural biotechnology:
(1) access to genetic resources—a key input for agricultural
research—and sharing of the benefits from its utilization,
such as the Convention on Biological Diversity (CBD)
and the International Treaty on Plant Genetic Resources
for Food and Agriculture (ITPGRFA);
(2) intellectual property rights governing the use of propri-
etary technologies, such as the International Union for
the Protection of New Varieties of Plants (UPOV) Con-
ventions and the Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPs) under the World
Trade Organization;
(3) biosafety, including environmental and food and feed
safety, which is the focus of this article.
At the national level, regulations affecting agricultural biotech-
nology will have to reflect a country’s policy objectives for the
development of biotechnology capacity, and society’s desires
on how technology will affect it. Prior to designing regulatory
systems, governments will have to determine their objectives for
the use of biotechnology in social and economic development.
© 2012 Landes Bioscience.
Regulatory systems must be designed to meet those policy
objectives, as well as a country’s obligations under international
treaties.
The present article presents the main international instruments
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relevant to biosafety regulation and their key provisions. Inter-
national agreements and standards provide important guidance
but at the same time leave significant room for interpretation and
flexibility for countries implementing them. Implementation of
biosafety at the national level has proven to be a major challenge,
particularly in developing countries, while the international
framework is still in flux. These implementation challenges are
also discussed in this article.
International Instruments Dealing with
Biosafety Regulation
Potential environmental and human health impacts resulting from
the introduction of genetically modified organisms (GMOs)
resulted in increased public scrutiny and media attention for these
products. Debate about the potential risks of GMOs to the
environment of human health spurred attention to biosafety.
Biosafety is associated with the safe use of GMOs in contained
conditions (e.g., in the laboratory), in confinement (experimental
field trials) and in general, unconfined introductions into the
environment. Biosafety regulation—the policies and procedures
adopted to ensure that the application of modern biotechnology is
safe to humans and the environment—has been extensively
discussed at various national and international forums. Much of
the discussion has focused on developing guidelines, appropriate
legal frameworks, and, at the international level, on developing a
legally binding international biosafety protocol—the Cartagena
Protocol on Biosafety, as discussed below.
Generally, developed countries, as leaders in technology
development, started to regulate biotechnology at the national
www.landesbioscience.com GM Crops and Food: Biotechnology in Agriculture and the Food Chain
RESEARCH PAPER
level in the mid-1970s and early 1980s (see, for example, Berg,
1977).2 Therefore, the regulatory systems in countries like the
United States and in Europe are relatively well defined. Based on
decades of experiences to date, the type of information relevant
and required for the assessment of GMOs has been laid down in a
number of international guidance documents published by the
OECD (2010),3 which have proven to provide an adequate basis
for GMO risk assessment.i
Developing countries generally have started the development
of their national biosafety systems more recently, and, as with
other areas of regulation, the task has been difficult. For most of
them, the Cartagena Protocol on Biosafety (CPB), a supplement
of the Convention on Biological Diversity (CBD) that addresses
the environmental impact of transboundary movement and the
management and safe use of genetically modified organisms, is the
starting point.
The Cartagena Protocol on Biosafety: Key provisions. In
January 2000, over 130 governments reached agreement on the
Cartagena Protocol on Biosafety (CPB), which regulates the safe
transfer, handling, and use of living modified organisms (LMOs)ii
resulting from modern biotechnology. The objective of the
Protocol is “to contribute to ensuring an adequate level of
protection in the field of 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 diversity, taking also into account risks to human
health, and specifically focusing on transboundary movements.”4
As of November 2011, 162 countries had ratified or acceded to
the CPB. The Protocol entered into force on September 11,
2003, 90 d after receipt of the 50th instrument of ratification. An
in-depth analysis of the Cartagena Protocol can be found in Low
and Frederick (2011)5 and Mackenzie et al. (2003)6 (Table 1).
The two cornerstones of the CPB are Advance Informed
Agreement (AIA) and the precautionary approach. AIA enables
an importing country to subject all first imports of LMOs to risk
assessment before taking a final decision on import. The Protocol
provides details on the whole process of notification, acknow-
ledgment and decision, which is supposed to be completed in
270 d. Detailed information must be provided by the importer
on notification, and LMOs should be clearly identified by
accompanying documentation.
However, the Protocol’s AIA procedure does not apply to
certain categories of LMOs (see Table 1): LMOs that are
pharmaceutical for human use and that are addressed by other
relevant international agreements or organization, LMOs in
transit and LMOs destined for contained use. For LMOs
intended for direct use as food or feed or for processing (LMO-
FFPs), the Protocol suggests a simplified procedure rather than
full AIA. It should be noted that, while the Protocol’s AIA
procedure does not apply to certain categories of LMOs, parties
i
For further information, see URL: http://www.oecd.org/topic/0,2686,en_
2649_34385_1_1_1_1_37437,00.html
ii
Living modified organisms (LMOs) are organisms whose genetic material
has been altered through modern biotechnology and which are capable of
propagation.
79
Table 1. Scope of the Cartagena Protocol on Biosafety and the AIA Procedure
LMO Category Relevant Provisions
LMOs subject to the Protocol All LMOs which may have adverse effects on the conservation and sustainable use of biological diversity,
taking also into account risks to human health
LMOs subject to AIA provisions LMOs intended for intentional introduction into the environment
LMOs excluded from the Protocol’s AIA ▪ LMOs in transit
provisions ▪ LMOs destined for contained use in the party of import
▪ LMOs intended for direct use as food or feed or for processing (LMO-FFPs)
▪ LMOs identified by the meeting of the parties to the Protocol as being not likely to have adverse impacts
LMOs excluded from the Protocol’s LMOs that are pharmaceuticals for humans that are addressed by other international organizations or
provisions on transboundary movements agreements
Source: Mackenzie R, Burhenne-Guilmin F, La Viña A and Werksman JD, in cooperation with Ascencio A, Kinderlerer J, Kummer K and Tapper R. An
Explanatory Guide to the Cartagena Protocol on Biosafety. Gland, Switzerland and Cambridge, UK 2003: The World Conservation Union (IUCN).

have the right to regulate their importation on the basis of
domestic legislation. For bulk commodities containing LMO-
FFPs, documentation will have to state that the shipment “may
contain” LMOs (in case the specific identity of the LMO is not
known) or that the shipment “contains” LMOs (when their
identity has been determined) and that the contents of the
shipment are not intended for planting. It is also important to
use of their transboundary movement, as well as the national
laws which will apply regarding their import. In addition, parties
without national regulatory framework can, through the BCH,
declare that they require notification and risk assessment prior to
importing an LMO-FFP.
In short, the most immediate focus of the Protocol is on trade
(import and export) of genetically modified seeds intended for

© 2012 Landes Bioscience.

note that parties to the Protocol have the option of exempting
imports of certain LMOs from the AIA procedure or require a
simplified notification procedure, provided that adequate safety
planting in the field, or for direct use as food and feed or for
processing. Before a GM seed can be shipped for the first time,
the importing country must decide whether to approve it. If the
measures are in place. This provision takes into account future seeds are approved for import, they will need documentation

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developments when specific LMOs will have a track record of safe
use in a range of importing countries.
The precautionary approach, as applied in Article 11 of the
Protocol, asserts that “lack of scientific certainty due to insuffi-
cient relevant scientific information and knowledge regarding
the extent of the potential adverse effects of a living modified
organism on the conservation and sustainable use of biological
diversity in the party of import, taking also into account risks to
human health, shall not prevent that party from taking a decision,
as appropriate, with regard to the import of that living modified
organism intended for direct use as food or feed, or for processing,
in order to avoid or minimize such potential adverse effects.” In
plain terms, including this approach allows countries to block
imports of, for example, seeds of genetically modified plant
varieties on a precautionary basis even in the absence of sufficient
scientific evidence of their harmfulness.
The Protocol established a Biosafety Clearing-House (BCH),
to facilitate exchange of scientific, technical, environmental and
legal information on LMOs, and to assist parties to implement the
Protocol. Parties should make available to the BCH:
N Laws, regulations and guidelines for implementation of the
Protocol;
N Bilateral, regional and multilateral arrangements covering
transboundary movement of LMOs;
N Decisions on imports or releases of LMOs;
N Summaries of risk assessments or environmental reviews of
LMOs by regulatory review processes.
The BCH has an important role regarding LMO-FFPs as it is
the mechanism through which parties will be made aware of the
provided by the exporter specifying their identity and traits. While
progress has been made by successive Meetings of Parties (MOP)
under the CPB in specifying documentation requirements for
LMOs and LMO-FFPs, this subject matter is still evolving.
Recent developments regarding the Protocol. A number of
issues that were pending at the time of signing the Cartagena
Protocol are gradually being addressed in successive meetings of
parties to the CPB. In October 2010, the CPB was “completed”
with the adoption of the Supplementary Protocol on Liability
and Redress, adopted at the fifth Meeting of Parties in Nagoya,
Japan. The Supplementary Protocol had been the last outstand-
ing element in a functional Biosafety Protocol, and is expected
to enhance the effectiveness of both environmental protection
measures and the Biosafety Protocol itself. As adopted, it should
strengthen the Cartagena Protocol’s objective to provide for the
safe transfer, handling and use of LMOs that may have adverse
effects on biodiversity by compensating for, and preventing,
damage to the environment. Its effectiveness remains to be
seen, as it relies on the ability of countries to measure this
damage under the highly specific guidelines of an administrative
approach rather than strict liability. The Supplementary Protocol’s
administrative approach also places the burden of proof on the
claimant, meaning the more resources and knowledge a country
has the more it will be able to apply the supplementary protocol
effectively.
Another key element being elaborated concerns risk assessment
and risk management, which is the cornerstone to biosafety
decision making. The general principles, general methodology and
points to consider in risk assessment of LMOs are laid down
in the Protocol’s Annex III. Recently, an expert group on risk

80 GM Crops and Food: Biotechnology in Agriculture and the Food Chain Volume 3 Issue 1
assessment and risk management has been established to, among
other things, prepare a “roadmap” and an action plan and con-
sider possible modalities for cooperation in identifying LMOs
or specific traits that may have adverse effects on biological
diversity, taking also into account risks to human health. The
expert group produced a report, titled “Guidance on Risk
Assessment of LMOs” (SCBD, 2010),7 which has subsequently
undergone an expert review by parties, other governments and
relevant organizations.iii
Finally, a start has been made in defining socioeconomic
considerations in LMO decision making. Article 26 of the CPB
establishes the right of parties to take into account socioecono-
mic considerations arising from the impact of LMOs on the
conservation and sustainable use of biodiversity, especially with
regard to the value of biodiversity to indigenous and local
communities, in reaching a decision on whether to import
LMOs. The inclusion of socio-economic considerations in parties’
decision-making on the import of LMOs must be consistent
with their other international obligations. The Protocol also
encourages parties to cooperate on research and information
exchange on any socio-economic impacts of LMOs, especially
on indigenous and local communities. Information exchange is
© 2012 Landes Bioscience.
being encouraged through surveys, collection of case studies
and online conferences on socio-economic considerations. This
part of the process will be concluded through an international
experts’ workshop on capacity-building for research and informa-
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tion exchange on socio-economic impacts of LMOs, held in
November 2011.
Relating to WTO Agreements: SPS and TBT
Parties to the Protocol will need to carefully interpret and
implement its provisions in line with existing trade agreements
that may affect GMOs, such as those governed by the World
Trade Organization (WTO).
The CPB makes clear that parties must develop or have access
to “the necessary capacities to act on and respond to their rights
and obligations.” However, the Protocol provides considerable
flexibility with respect to how importing countries may meet their
obligations with respect to risk assessment and LMO decision
making and the implementation of these decisions. As stated in
Article 16, which deals with risk management, each party has an
obligation to “establish and maintain appropriate mechanisms,
measures and strategies to regulate manage and control risks
identified in the risk assessment provisions.” Parties have agreed
to carry out these risk management functions under the CPB,
but how a country fulfills this obligation is not yet clarified—as
discussed above—and only defined in generic terms in an annex
to the Protocol. It is also recognized that developing country
parties and parties with economies in transition will require
assistance to achieve this function, including financial support.
Within the WTO, biosafety of GMOs falls mainly under
the Agreement on Sanitary and Phytosanitary Standards (SPS
iii
Submissions have been made available at URL: https://bch.cbd.int/
onlineconferences/guidance_ra/review.shtml
www.landesbioscience.com GM Crops and Food: Biotechnology in Agriculture and the Food Chain
Agreement).iv The SPS Agreement does not explicitly address
GMOs or LMOs but is important as it deals with laws and
regulations that concern food and feed safety and animal and
plant health. The SPS Agreement allows WTO member countries
to take restrictive measures to protect themselves from food safety
risks, animal health risks and invasive species risks from GMOs.
The agreement requires that such measures be based on scientific
risk assessment based on internationally accepted standards, and
that they do not arbitrarily or unjustifiably discriminate between
countries so that any measures taken are not disguised trade
restrictions. When GMOs are traded internationally and are
considered as a threat to human, animal or plant life or health in
an importing country, risk management measures can be taken
prior to their import. Member state can also take into account
relevant economic factors when taking sanitary or phytosanitary
measures.
The SPS agreement allows for provisional precautionary mea-
sures in cases where scientific information is insufficient. In such
cases, countries would be obliged to actively seek additional
information for a more comprehensive risk assessment, and to
review the provisional measure within a reasonable period. This
definition of the precautionary approach could be in conflict with
the more “generous” interpretation included in the CPB.
In addition to the SPS Agreement, the WTO Agreement on
Technical Barriers to Trade (TBT)v may apply to GMO pack-
aging and labeling. The TBT Agreement is intended to ensure
that WTO members do not use technical regulations, standards,
testing and certification procedures as disguised measures to
protect domestic industries from foreign competition. The TBT
Agreement allows governments to adopt technical regulations if
they protect human health or the environment. Such measures
should not be unnecessarily trade-restrictive and not discrimi-
natory between locally produced and imported goods. It would
apply, for example, in cases where a country requires imported
products to include in their labels any traces of GMOs.
The SPS and TBT agreements under the WTO encourage
harmonization among member countries on the basis of inter-
nationally accepted scientific standards. The SPS Agreement
explicitly recognizes the standards developed by three relevant
organizations: the FAO/WHO Codex Alimentarius Commis-
sion,8 the Office International des Epizooties (OIE—the World
Organization for Animal Health),9 and the International Plant
Protection Convention (IPPC).10 These standard-setting bodies
all have their working groups on safety aspects of GMOs and
GM foods, and the resulting standards, recommendations and
guidelines should be the basis for WTO members’ sanitary
and phytosanitary measures or technical regulations regarding
LMOs.
The Codex Alimentarius Commission or Codex, a United
Nations agency under the Food and Agriculture Organization
(FAO) and the World Health Organization (WHO), has so far
iv
For a full text of the SPS Agreement, see URL: http://www.wto.org/english/
tratop_e/sps_e/spsagr_e.htm
v
Further details on TBT and full text of the Agreement, see URL: http://www.
wto.org/english/tratop_e/tbt_e/tbt_e.htm
81
published the following official standards dealing with GM food
safety:
N Principles for the Risk Analysis of Foods Derived from
Modern Biotechnology (GL 44–2003)
N Guideline for the Conduct of Food Safety Assessment
of Foods Derived from Recombinant-DNA Plants (GL
45–2003)
N Guideline for the Conduct of Food Safety Assessment of
Foods Produced Using Recombinant-DNA Microorganisms
(GL 46–2003)
N Guideline for the Conduct of Food Safety Assessment
of Foods Derived from Recombinant-DNA Animals (GL
68–2008)
The Codex guidelines are elaborated through expert consulta-
tions and broad-based taskforces, in this particular case the Ad
Hoc Intergovernmental Task Force on Food Derived from
Biotechnology. The Codex Committee on Food Labeling took on
the issue of developing guidance on GM food labeling as early as
1993 but so far protracted negotiations have not resulted in an
agreed guideline.
The International Plant Protection Convention (IPPC) is an
© 2012 Landes Bioscience.
international agreement on plant health under FAO. The aim of
the IPPC is to control and prevent the spread and introduction
of pests of plants and plant products. The IPPC’s Commission on
Phytosanitary Measures (ICPM) develops standards for phytosa-
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nitary measures, which includes a standard dealing with LMOs
(No. 11 on “Pest risk analysis for quarantine pests including
analysis of environmental risks and living modified organisms”).
A supplement to the original ISPM No. 11 on pest risk analysis
for LMOs was adopted by the ICPM in 2004. The supplement
provides guidance to national phytosanitary agencies regarding
the analysis of potential pest risks posed by LMOs. If a GM plant
or crop has the potential to be a “pest” in IPPC terms—i.e., could
have a negative impact on plant health—it would fall within the
scope of the IPPC and therefore could be subject to phytosanitary
measures, as indicated in guideline No. 11.
The World Organization for Animal Health (OIE) is an
intergovernmental organization created to provide information
regarding the global animal disease situation. Its standards are
aimed at preventing the introduction of infectious agents and
diseases through international trade in animals. In similar fashion
to the Codex Alimentarius and the IPPC, WTO’s SPS Agreement
requires WTO members to base their sanitary and phytosanitary
measures in the area of animal health on the standards, guidelines
and recommendations of the OIE. The standards set by the OIE
do not make specific reference to LMOs, but they would fall
within their scope in case they pose an animal health risk.
International standards such as those developed under Codex
and the IPPC provide important guidance to countries imple-
menting the CPB, as they partially address the science-based risk
assessment procedure as laid down in Annex III to the Protocol.
These standards are as such not legally binding on the parties to
Codex and the IPPC; however, the WTO Agreement requires
WTO members to base their trade measures on these standards,
guidelines and recommendations.
82 GM Crops and Food: Biotechnology in Agriculture and the Food Chain
The Cartagena Protocol and WTO agreements as introduced
above clearly have a different scope and present different
perspectives on trade flows of GMOs and potential adverse
effects, which may give rise to disputes between GMO-exporting
countries and potential importers. While the SPS Agreement
places the burden on countries imposing restrictive measures, the
Protocol imposes burden on exporters under the AIA procedure.
The risk of potential conflict increases as the parties to the
Protocol adopt more detailed rules and implementation require-
ments over time. There is no template for ensuring WTO-
consistency in the design or implementation of national laws and
regulations on biosafety. Many aspects of the relationship between
the Protocol and the WTO remain unclear, and will be worked
out in practice in the future.
Implementing the International Framework:
Key Challenges and Uneven Progress to Date
As in any international environmental and trade agreements, the
efficient adoption and application of internationally agreed
biosafety principles and standards at the country level is critical
to their success. In order to be able to implement their obliga-
tions under the CPB and other international agreements, parties
need appropriate institutional mechanisms and infrastructure,
coordination between environmental and agricultural regulatory
bodies, well-trained human resources, political commitment,
adequate funding, as well as easy access to relevant information
on LMOs.
The Protocol is a good model for some components of a
national biosafety regulatory system; however, because of its
limited scope on transboundary movement of LMOs, it provides
little guidance on several issues key to biosafety regulation. The
Protocol gives discretion to individual countries to decide on what
risk/safety standard to apply on transboundary movements of
GMOs, how to incorporate socioeconomic considerations into
decision-making processes, how to address food safety and how to
incorporate public participation.
In the last few years the Global Environment Facility (GEF)
and a range of multilateral and bilateral donor agencies have
provided support to a wide array of biosafety capacity deve-
lopment projects. A detailed overview of these biosafety capacity
development projects is beyond the scope of this article, and can
be found in regular reports issued by the CBD Secretariat11 and
in Maredia, Weebadde, Komen, Ghosh (2011).12 Generally, these
projects have aimed at supporting the implementation of the
CPB by establishing functional national biosafety frameworks
(NBFs).
While progress has undoubtedly been made, especially in
defining and establishing national biosafety frameworks in a
number of countries, there is growing concern that many CPB
parties still do not have the necessary capacity in place at the
national level to implement the Protocol. And they appear to
have no prospects for developing it in the foreseeable future. This
issue has been noted in successive meetings of the Compliance
Committee under the cartagena Protocol on Biosafety. In 2008,
for example, the committee noted that:
Volume 3 Issue 1
 “[T]here are significant gaps regarding the introduction of the
necessary legal, administrative and other measure required to
implement the Protocol. The Committee considered this to be a
serious issue of non-compliance […]” (SCBD, 2008)13
A recent discussion paper (SCBD, 2010)14 issued by the CBD
Secretariat also concludes that:
“Notwithstanding the significant activity and effort that has
been devoted to the Protocol’s implementation since its adoption,
there remain gaps and deficiencies in implementation.” (p.4)
Specifically, the paper states that:
“[…] it is evident that a state that has completed the NBF
process is not necessarily in a position to implement the Protocol
in terms, for example, of dealing with an application for the first
import of an LMO for intentional introduction into the environ-
ment. In some cases, while draft legislation may have been pre-
pared, it has not been enacted; and in others secondary regulations
that form an integral component of an operational regulatory
system have not been finalised and adopted. In numerous cases, it
is suggested, even though a regulatory framework has been put in
place, Parties may not be in a position to process an application
due to a lack of sufficient technical or other capacity.” (p.3)
A study conducted by UNU-IAS (2008)15 involved an in-depth
© 2012 Landes Bioscience.
review of biotechnology and biosafety capacity-building programs,
and is the only attempt so far to comprehensively look at the
inherent challenges. This assessment found that a majority of
developing countries, including most countries of Africa, Central
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Asia, Oceania and the Caribbean, were unable to manage modern
biotechnology and implement their NBFs. The study noted that
capacity deficiencies are:
“[…] so pervasive and broad that there is no effective interna-
tional system of biosafety at the moment. In addition, the volume
of resources available to address these needs in the coming years
appears insufficient to provide the necessary support for countries
to implement their basic obligations under the CPB.” (p.11)
A high proportion of countries without functioning domestic
frameworks creates a situation that is becoming a major impedi-
ment to achieving the objectives of the CPB. Moreover, as new
elements are added to the Protocol such as the supplementary
protocol dealing with liability and redress, the pattern of
implementation issues gaps and associated capacity development
constraints will become increasingly difficult to address, which
would eventually result in trade conflicts. On this point, it is also
important to note that the major agricultural exporting countries,
among them leading countries in terms of GM crop plantings,
have not joined the Protocol, including Canada, Argentina,
Australia, Russia, and the United States.
Conclusions and Recommendations
The development, release, adoption, and application of agricul-
tural technologies are increasingly subject to public scrutiny and
regulatory controls, particularly through biosafety frameworks.
This is reflected in the Cartagena Protocol on Biosafety and
associated development of national biosafety frameworks. As
discussed in this article, there are no blueprints or templates for
the implementation of the Protocol or any other international
www.landesbioscience.com GM Crops and Food: Biotechnology in Agriculture and the Food Chain
agreement or standards relevant to biosafety. A good number of
countries have developed or are in the process of developing
biosafety policies, laws and implementing regulations and guide-
lines, largely with support of donor-funded projects and programs,
though progress has been uneven across countries. For many
countries, more work is needed to achieve fully functional NBFs.
While policymakers and research managers involved in
agricultural research have to deal with increasing complexities, a
number of measures are cited in this final section that illustrate
ways in which emerging concerns can be addressed effectively.
Governments need to develop and implement comprehensive
national policy frameworks that guide the use of, and access to,
genetic resources and biotechnology applications. International
agreements such as those summarized above will have to be
translated into national laws and regulations and a coordinated
framework for biosafety among the various national regulatory
agencies. Ideally, this development would be in line with a
country’s overall objectives for agricultural and rural development.
National policies and strategies are instrumental in developing
laws and regulations that are complementary and mutually
reinforcing and responsive to international agreements.
Regarding the development of national biosafety frameworks
and associated capacity, it should be noted that in industrialized
countries these frameworks were usually developed in piecemeal
fashion, beginning with voluntary guidelines and standards
developed cooperatively by academia, industry and government,
which have been incorporated over time into legal instruments
either under existing legislation covering food and agricultural
products or environmental management or under new legislation
dealing specifically with biotechnology. The evolution of biosafety
policy and its implementation is ongoing and it is not unusual
to have a mix of voluntary and statutory mechanisms, even in
those countries with long established frameworks. A similar
development can be observed in developing countries that were
among the early adopters of biotechnology and GM crops: In
countries such as Egypt, the Philippines, South Africa, Kenya and
Uganda, among others, significant experience was gained with
contained experiments and confined field trials of GM crops
under prior existing legislation or amended acts, well before the
development of more comprehensive biosafety laws and regula-
tions.
Finally, collaboration and information exchange among
countries in the same (sub-) region should expand. There are
currently a number of promising initiatives at the regional level
that encourage technical and political collaboration among
countries on biosafety regulatory issues. Regional collaboration
on biosafety issues aims to ensure that the information used in
risk/safety assessments, as well as the methods used to collect
such information, are as similar as possible across countries.
This can lead to countries recognizing or even accepting
information from one another’s safety assessments, and may
generate significant benefits. It increases mutual understanding
among member countries of each other’s risk assessments, it
avoids duplication of effort, it saves on scarce resources, and
it increases the efficiency of the risk/safety assessment process.
A number of regional political and economic integrations
83
organizations have developed a strong interest in biosafety,
partially as a result of various capacity development support
projects. These include the African Union; the Common Market
for East and Southern Africa (COMESA), the West African
Economic and Monetary Union (WAEMU), the Caribbean
Community (CARICOM) and the Association of South East
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Volume 3 Issue 1