Annotated Bibliography Entry
Reference:
ISNAR 2002a
Title: A
Conceptual Framework for Implementing Biosafety: Linking Policy, Capacity, and
Regulation
Authors:
McLean,
M.A., Frederick, R.J., Traynor, P.L., Cohen, J.I. and Komen, J.
Publisher:
International Service for National Agricultural Research (ISNAR), The
Netherlands
Publication details: ISNAR
Briefing Paper 47, March
2002, 12p
Summary
Conceptual Framework for Biosafety Regulation
The Cartagena Protocol on Biosafety
The five elements of the conceptual framework
Fig.1
Basic
elements providing for implementation of biosafety regulations
Crosscutting Issues:
Transparency; Public Participation; Resources;
Table 1 Key
Decision Points & Policy Options
Conclusion
Further Information
Annex:
ISNAR 2003 Table of Contents
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to ISNAR page
Summary
Products
arising from modern biotechnology provide new opportunities to achieve
sustainable productivity gains in agriculture. Concerns over their possible
environmental and health implications stimulated regulatory mechanisms for
food safety and environmental risk assessment. Over the past two decades,
national biosafety frameworks, guidelines, and regulatory systems have often
been implemented on a “piece-by-piece” basis in
response to the demands or urgent needs of the moment. Ideally, a biosafety
system would be developed from a comprehensive plan. However, building such a
system and making it operational is complicated by the fact that there is no
single best approach nor standard that reflects national environmental,
cultural, political, financial, and scientific heterogeneity.
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Conceptual
framework for biosafety regulation
Given
these challenges and difficulties inherent in building regulatory systems and
needed capacity, the International Service for National Agricultural Research
(ISNAR) convened an expert consultation in July 2001. The purpose of this
meeting was to develop a conceptual framework to address regulatory
implementation and capacity-building needs of developing countries and Parties
to the Protocol. A framework for implementing national biosafety systems
emerged, which consists of the following five elements:
· National
policies, strategies, and research agendas regarding biosafety;
· National
inventory and evaluation;
· The
knowledge, skills, and capacity base to develop and implement a biosafety
system;
· Development
of regulations; and
· Implementation
of regulations.
The
conceptual framework clarifies critical decision points in the development of
a national biosafety system, systematically examines choices among policy
options, and delineates some of the scientific and social dimensions of these
options. It complements ongoing regional and global projects that facilitate
the development of national biosafety guidelines and frameworks.
The
conceptual framework for biosafety implementation presented in this paper is
based on a synthesis of the contributions made to an international expert
consultation entitled “A Framework for Biosafety Implementation: A Tool for
Capacity Building.” Background for the framework and substantial
documentation can be found in the full proceedings (ISNAR, 2003).
The
framework expands on the conceptual basis used for ISNAR’s national
biosafety system studies in Egypt and Argentina and on concepts and lessons
derived from other national, regional, and international experiences analyzed
during the consultation.
The
purpose of this framework is to address national needs regarding regulatory
implementation and capacity building, in particular of those countries that
are Parties to the Cartagena Protocol on Biosafety. The framework is meant to
complement the UNEP/GEF Global Project on the Development of National
Biosafety Frameworks by providing guidance on the design and implementation of
regulatory frameworks and related capacity-building initiatives. It is not
intended to be a common road map for all Parties or countries to follow.
Instead, the objective is to clarify critical decision points in the
development of a national biosafety framework, to examine choices among policy
options, and to delineate some of the scientific and social dimensions of
these options. The consequences of policy choice on the efficiency and
effectiveness of biosafety regulations are presented in more detail by McLean
et al. (2001)1.
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The
Cartagena Protocol on Biosafety
Adopted
in January 2000 as a supplement to the Convention on Biological Diversity, the
Cartagena Protocol on Biosafety (the Protocol) addresses the safe transfer,
handling, and use of living modified organisms (LMOs) that may have an adverse
effect on biodiversity, taking into account risks to human health and focusing
specifically on transboundary movements. The Protocol allows governments to
indicate their willingness to accept imports of agricultural commodities that
include LMOs by communicating their decision to the world community via the
Biosafety Clearing House, a mechanism set up to facilitate the exchange of
information on, and experience with, LMOs. The aim is to ensure that recipient
countries have both the opportunity and the capacity to assess risks involving
the products of modern biotechnology.
National,
regional, and international agencies have recognized that successful
implementation of the Protocol is contingent on the development of national
biosafety capacity in countries that have yet to establish, or are in the
process of establishing, biosafety systems. The Protocol makes clear that
Parties to the Protocol must develop or have access to “the necessary
capacities to act on and respond to their rights and obligations.” The
Protocol provides considerable flexibility as to how importing countries may
meet their obligations with respect to risk-management decision making and to
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”.
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The
five elements of the conceptual framework
The
framework addresses five elements that are fundamental to the development and
implementation of a national biosafety system (Figure 1).
Figure 1. Basic
elements providing for implementation of biosafety regulations
The first
two elements—national policies, strategies, and research agendas regarding
biotechnology and biosafety, and a national inventory and evaluation—provide
the foundation for subsequent regulatory implementation. The next
element—requisite knowledge, skills, and capacity base—is the resource
environment within which the final two elements occur: development of
regulations and implementation of regulations.
National
policies and the inventory and evaluation do not lend themselves to the format
used to analyze the other three elements, where decision points, policy
options, and key questions were identified. National biosafety strategy is
discussed conceptually, and national appraisal is addressed by broadly
identifying the capacities available and needed to implement the Protocol.
Three crosscutting issues, common to each element of the framework, are also
identified and discussed: transparency, public participation, and resources.
Using
this framework to help build more comprehensive regulatory systems gains
importance as developing countries contend with increasing numbers of
applications for confined field trials and commercial release. Expanding needs
for assessments require careful planning to build the necessary capacity base
and to clarify policy and system objectives to expedite review decisions.
Otherwise, review procedures will be delayed not by the assessment, but by
lack of clarity regarding policy or political matters.
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Crosscutting
issues
Crosscutting
issues are the ones encountered during each stage of the development and
implementation of a national biosafety system, and they are often the most
challenging factors to address and resolve. These are the issues that will
ultimately dictate the scope of a national policy on biosafety, and the
conversion of policy into practice. Crosscutting issues affect the
implementation of the system designed to assess biosafety, and perhaps more
important, those nontechnical factors that are crucial to the public’s
acceptance of and confidence in the decisions that are made by government on
behalf of the people.
Transparency
The
twin issues of public information and participation relate to the degree of
transparency in a regulatory system and to the extent to which the public can
provide input to the formulation either of a regulatory policy, or of specific
regulatory decisions. In this context, transparency refers to the amount and
level of information that governments provide on why and how certain products
are regulated, on how risk assessments are performed and decisions made, and
on what conclusions are reached. Transparency can also relate to the perceived
independence and objectivity of the regulatory decision makers. Although
closely related, public information and participation have some mutual
exclusivity, as it is certainly possible to have an open and transparent
process that, however, does not involve public input.
Greater
transparency concerning both the risks and benefits of biotechnology products
and government decision-making is an essential component of building public
trust in new technologies. The dissemination of more and better information on
agricultural biotechnology is a stabilizing force because, while the public
may not generally read scientific studies, risk assessments, or
government-decision documents, opinion leaders, members of special interest
groups, or others who hope to shape public opinion, do.
Government
policy on transparency will determine the extent to which the public and
special interest groups will contribute to the development of a national
biosafety policy; the opportunities for public participation in the
risk-assessment and decision-making process; and the degree to which the
public will have ready access to information about the biosafety system, the
process of decision making, and the regulatory decisions that are made.
Public
participation
Opportunities
for public participation will necessarily reflect the political and cultural
environment of a country. Countries with a history of citizen engagement in
policy development are likely to include the public in the process of
developing a national biosafety system, and the converse is also true. Public
participation in the evolution and implementation of a national biosafety
system may be the most significant factor in determining the level of public
confidence in the risk assessment and management of LMOs.
Mechanisms
for public participation include the following:
·
Advisory
committees, particularly those tasked with evaluating the social, ethical, and
economic dimensions of biosafety, where one or more members of the public
should be included;
·
Public
hearings or individual contributions during the development and amendment of
biosafety guidelines and regulations;
·
Contributions
during the risk-assessment process. This will require that the public be
informed about products under review and provided with a process through which
they can make submissions about the approval of an LMO.
Resources
Human,
financial, and infrastructure resources largely determine the scientific and
administrative capacity of any country and so obviously influence any
biosafety related policy or program. Funds must be available to develop and
implement a national biosafety system; to support the infrastructure required,
e.g., buildings, labs, equipment, and computers; to facilitate communication
and public participation; to train scientific and regulatory personnel; and to
foster the research required to assure that risk assessments are sound.
Fundamental
to any national biosafety system is a strong base of scientific knowledge in
support of the regulatory system and the development of core competencies in
biotechnology product evaluation (Table1).
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Table 1. Key Decision Points and Policy Options Related to Science and the
Knowledge Base Supporting Biosafety Regulation
New Genetics, Food &
Agriculture: Scientific Discoveries - Societal Dilemmas
