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Date:

September 28, 2000

Subject:

Commercialism, ISAAA, Harvard

 

Knight Ridder/Tribune
September 22, 2000, Friday
Case against biotech food has to do with commercialism, not safety
By Douglas T. Nelson

Ah, here at the end of summer, we are back to reading about the survival
of the Monarch butterfly. On Aug. 19, critics of agricultural biotech
again unveiled their "poster insect" with the release of a second study
that purports to show the potential risks Monarch butterflies could face
with new biotech farming techniques. The study, released by a researcher
at Iowa State University, charges that monarch butterflies can die when
they feed on a B.t. microbe in biotech plants.

It is the latest salvo in the contentious war over the environmental
impact of agriculture biotech. But hidden from public view is a simmering
environmental controversy: which farming technique is more dangerous to
the Monarch butterfly and the environment- biotechnology or organic
farming?

At first blush, the question seems out of place. What does organic farming
have to do with genetically altered crops? The answer has rarely been
discussed outside of scientific and agricultural circles, but it gets to
the heart of the current debate over our food supply.

Although food critics rarely mentioned it, the same "villainous" B.t.
pesticide that is used in biotech crops is the same pesticide used by
organic farmers to protect their vegetables. America's farms today harvest
millions of acres of B.t. potatoes, corn and cotton. They contain the
genes of the naturally occurring microbe, B.t. When plant breeders insert
B.t. into these crops, it enables the plant to create its own defense
against borers and caterpillars without spraying the plants. This protein
is harmless to humans or to the plants but deadly to the pests. The
caterpillars and borers die when they bite the leaves of a B.t. plant.

Reducing the need to spray B.t. pesticide on crops should be good news to
environmentalists. But there is a catch. Organic farmers spray millions of
acres of B.t. on their crops too. And they have been among the most
determined critics of biotech crops. In 1997, 13 organic trade
associations filed a landmark petition with Greenpeace calling for the
U.S. Environmental Protection Agency to ban the right to grow B.t. crops
in this country.

The organic industry's fear is that since biotech crops do not require
pesticide spraying the biotech produce could compete with organic foods.
Many privately express the fear that biotech could commercially flatten
their industry. Who can blame them? If conventional crops can be sold more
affordably without the use of insecticides, organic farmers who already
charge very high prices for their fruits and vegetables could be in
trouble. Who has not almost fainted from sticker shock when looking at
organic produce prices in a supermarket?

Regardless of motive, consumers want straight answers. Do biotech crops
endanger the Monarch butterfly? About two months ago the EPA, not normally
regarded as an apologist for the biotech industry, answered with a clear
no. The agency rejected the organic industry's petition in a stunning
107-page single-spaced document that concluded "the currently available
evidence does not support the conclusion that registered (biotech plants)
may cause unreasonable adverse effects on the environment."

Addressing the specific issue of the Monarch butterfly and non-target
insects the EPA said, "Published field testing results and field test data
submitted to EPA show minimal to undetectable changes in the beneficial
insect population." EPA further concluded that biotech crops "reduce
adverse effects on non-target organisms because the organisms most likely
to receive a dose... are those feeding on the crop." Non-target insects
usually do not eat the crop leaves, and spraying B.t. is less
discriminating, potentially killing beneficial organisms." In fact, EPA
believes that available scientific data and information indicates that
cultivation of B.t. crops has a positive ecological effect, when compared
to "most likely alternatives."
The "most likely alternatives" are conventional and organic farming using
B.t. sprays.

In simulated tests cited by critics, larvae were force-fed B.t. at very
high doses. EPA rejected the procedure, noting "in the field, insects are
usually exposed to smaller amounts of toxin than the laboratory test dose
because in the field there is a greater choice of diet." The Iowa State
study ignored the EPA critique and duplicated the same test. The
researcher designed worst-case conditions bearing little resemblance to
real world. The
unrealistic conditions included relying on the highest potency strain that
makes up only 2 percent of the total B.t. corn, and in a laboratory
literally placing the larvae on the leaves to feed, giving it no
alternative food source.

Unfortunately, the case against biotech food has nothing to do with
safety, health or the environment, but with commercial interests. The
sadness of it all is that the organic farmers aren't willing to confront
biotech foods head on. Instead, they wish to hide behind the facade of
caring about the environment.

ABOUT THE WRITER

Douglas T. Nelson is the senior vice president and general counsel of the
American Crop Protection Association, a nonprofit trade organization
representing major manufacturers, formulators and distributors of crop
protection, pest control and biotechnology products. Readers may write to
him at: American Crop Protection Association, 1156 Fifteenth St. NW, Suite
400, Washington, D.C. 20005.
==========================================================

Date: Sep 28 2000 20:17:45 EDT
From: "C. S. Prakash"
Subject: ISAAA PUTS UP KNOWLEDGE CENTER ON CROP BIOTECH; Annual
Conferenceof the European Biosafety Associati


News Release
International Service for the Acquisition of Agri-biotech Applications
8 September 2000

ISAAA PUTS UP KNOWLEDGE CENTER ON CROP BIOTECH

ISAAA, Los Banos, Laguna, Philippines. The International Service
for the Acquisition of Agri-biotech Applications (ISAAA) announces
the establishment of the Global Knowledge Center on Crop
Biotechnology. Based at the ISAAA Southeast Asia headquarters in Los
Banos, Laguna, Philippines, the Knowledge Center envisions itself as
a virtual science-based information network responding dynamically to
the needs of developing countries on crop biotechnology and related
issues.

Specifically, it will help national programs facilitate the
development of a policy environment conducive to the application of
biotechnologies; and promote public understanding of scientific
advances in crop biotechnology. To achieve these, the center shall
serve as a global hub promoting a dynamic exchange of science-based
information among national policy makers, regulatory staff,
scientists and other strategic sectors.

Dr. Clive James, ISAAA's Chair, says "The Knowledge Center was born
out of an urgent need for developing countries to have current
authoritative information for sound decision-making. This will be
realized through a network where consistent and focused sharing and
distribution of information will be pursued."

The Knowledge Center in collaboration with CAB International, United
Kingdom will put up an internet website called Crop Biotech Net and a
bi-weekly Crop Biotech Brief. CABI publishes AgBiotechNet
(http://www.agbiotechnet.com), a major resource covering agricultural
biotechnology. The Knowledge Center will encourage expert
networking and do continuous scanning of the agribiotechnology
environment. Other multi-media approaches will be developed for
various audiences interested in crop biotechnology.

Dr. Mariechel J. Navarro recently joined ISAAA as Managing Editor
of the Global Knowledge on Crop Biotechnology. She was recruited from
the University of the Philippines Los Banos where she was coordinator
of the Communication and Technology Utilization Program of the
National Institute of Molecular Biology and Biotechnology.. Dr.
Navarro has had extensive experience in promoting greater public
awareness of biotechnology through interpersonal and multi-media
approaches. As a communicator and researcher, she shares many of her
insights on biotechnology in various articles she has written.

Further inquiries on the Knowledge Center may be sent to the
following: knowledge.center@isaaa.org. or ISAAA SEAsiaCenter c/o
IRRI MCPO Box 3127, 1271 Makati City, Philippines.
======================================================

From: "Calestous Juma, Harvard University"
Subject: Re: [BIOTECH] Science and precaution

WWW site for this meeting can be found at:
http://www.iisd.ca/sd/biotech

INTERNATIONAL CONFERENCE ON BIOTECHNOLOGY IN THE GLOBAL
ECONOMY: SCIENCE AND THE PRECAUTIONARY PRINCIPLE

22-23 SEPTEMBER 2000

The International Conference on Biotechnology in the Global
Economy: Science and the Precautionary Principle took place
in Cambridge, Massachusetts, USA, from 22-23 September
2000. Organized and hosted by Harvard University's Center
for International Development (CID) and the Belfer Center
for Science and International Affairs, the conference
attracted over 200 participants from governments, industry,
non-governmental and intergovernmental organizations, and
research and academic institutions. The conference is part
of a series of events addressing key policy issues related
to biotechnology and globalization, with support from the
Rockefeller Foundation. The meeting aimed to explore the
policy and practical implications of applying the
precautionary principle in the field of biotechnology,
specifically with regard to: practical, theoretical,
historical and cultural aspects of the principle; previous
applications in international environmental and trade law;
the various definitions of the principle's use in
international discussions and negotiations; and social,
economic and political implications of the principle in
developed and developing countries.

Participants met in four full sessions to hear keynote
speeches and presentations addressing: an overview of the
principle; concepts and definitions; scientific and
technical foundations; and a recent publication on the
potential and hazards of genetically modified (GM) foods.
Participants also met in four parallel sessions using case
study presentations for discussion in the areas of:
national experiences; international experiences; policy and
institutional implications; and regulatory implications. A
closing plenary reviewed the findings of the conference and
discussed priorities for future work.

The outputs of this conference will include a summary
outlining next steps and a special journal issue on the
topic. This conference material is expected to contribute
to current efforts to develop research activities, provide
training and promote policy dialogue and awareness on the
safe use of biotechnology.

BACKGROUND

The safe use of modern agricultural biotechnology has
become one of the most contentiousdebates worldwide. There
is general agreement on the need to ensure the safety of
biotechnology products through effective risk assessment,
management and communication. However, countries differ on
how to reflect these measures in public policy and
decision-making. Some require that "sound science" be used
as a basis for restricting trade in products that pose a
threat to the environment and human health. Others,
however, argue for "precautionary measures" that allow
policy action to be taken in the absence of full scientific
certainty.

In 1992, the United Nations Conference on Environment and
Development (UNCED) adopted Principle 15, which states that
"where there are threats of serious or irreversible damage,
lack of full scientific certainty shall not be used as a
reason for postponing cost-effective measures to prevent
environmental degradation." A version of this principle was
recently incorporated into the Cartagena Protocol on
Biosafety under the Convention on Biological Diversity,
generating significant debate during its negotiation and
over its future interpretation. Issues regarding the
precise meaning, scope, context and application of the
precautionary principle will continue to draw attention and
create controversy, especially at the intersection of
international trade and environmental management.

REPORT OF THE CONFERENCE

OPENING PLENARY

Sara Sievers, Center for International Development (CID),
Harvard University, opened the meeting, noting CID's work
in the area of science and technology. She introduced
Calestous Juma, CID, as the meeting's Chair. Juma
highlighted how this conference builds on a similar meeting
held in September 1999 on the general topic of
biotechnology and the global economy. He cited significant
interest in understanding the relationship between
globalization processes and scientific progress, with
special attention to biotechnology and its socioeconomic
and political implications. He noted that the notion of
uncertainty is a central overriding factor encompassing
three of the key areas highlighted by the last conference -
environmental safety, safety for human health and the
safety of socioeconomic systems. Within this context of
uncertainty, he stated that no general agreement exists on
what the precautionary principle means or how it is applied
in different socioeconomic and cultural systems. Juma
expressed hope that this meeting could help create a common
language and vocabulary, and queried whether the principle
serves as a new perspective on uncertainty or whether it
complements existing approaches. He further noted that the
meeting would address national and international
experiences with the precautionary principle and its
formulation, as well as the ultimate implications for
policy, institutional and regulatory systems.

Jeffrey Sachs, CID, stressed the need to integrate
scientific and technological issues into global economic
development, noting that most proposed economic strategies
focus on "globalization" per se. He stated that the growing
gap between rich and poor countries is due to the
increasing divide in technological capacity. In this
regard, poor countries generally lack systems promoting
domestic innovation and are not adequately adopting and
adapting to technologies developed in the industrialized
world. He stated that biotechnology is still in its infancy
and that it will continue to grow, especially since poor
countries will need agro-biotechnology to feed growing
populations. Responding to the notion that biotechnology is
only for rich countries, he noted the nature of science is
to follow the market. He said the potential risks of
biotechnology should be assessed individually for developed
and developing countries, since developed countries should
not determine what are acceptable risks for developing
countries. In this regard, he noted the need for capacity
building to evaluate these risks.

Sachs stated that the precautionary principle is
essentially a risk assessment tool, and that if there are
no externalities, then individuals should be able to manage
their own risks. He proposed that labeling could be a
potentially useful mechanism. He also suggested the need
for: delivery assessment to look at biotechnology's net
effects; risk evasion frameworks to evaluate whether the
loss of a technological application is more painful than
its gains; investing in a better understanding of
biotechnology; decentralized decision-making; and using
independent scientists and peer reviews to evaluate risks.
In closing, he suggested that while the political debate
over biotechnology may continue in Europe, the furor will
subside elsewhere given its general adoption in the US,
China, India and increasingly in Latin America. He noted
the reluctance to adopt the technology in Africa, mainly
due to Europe's influence and donor role, but believed that
overall the technology will continue to grow.

John Holdren, Belfer Center for Science and International
Affairs, Harvard University, presented relevant comparisons
between the theoretical application of the precautionary
principle in biotechnology and his experience with
comprehensive risk assessment and management of alternative
energies. He critiqued the Wingspread formulation of the
precautionary principle, which states that when an activity
raises threats of harm to human health or the environment,
precautionary measures should be taken even if some cause
and effect relationships are not fully established
scientifically. He noted that it: offers little guidance on
the kinds of measures to be taken and the specific costs
and risks involved; constitutes a "prescription for
paralysis" and places health and environmental values over
economic ones. He noted that difficulties of managing risks
in society start with deciding how much and what kinds of
caution should be exercised under conditions of
uncertainty. Discussing hazard assessment, communication
and management, he enumerated relevant components,
including, inter alia: values of harm, expectation of harm,
maximum value of harm, distribution, resistance to remedy,
uncertainty and the role of potential victims. Pitfalls in
hazard comparisons might include: non-comparable benefits
and costs; narrow or inconsistent boundaries of analysis;
mixing average and marginal hazards; illusory perceptions;
preoccupation with quantification; and hidden values
inherent in decisions made by technical experts confusing
hazard assessment with hazard management.

Drawing from other sectors' experience, he noted that the
proponents of nuclear energy had undermined their own
credibility by asserting that no risk existed. In voicing
opposition to potentially harmful practices, he encouraged
support for establishing alternative methods. He also
advocated that extraordinary risks be entertained only in
exchange for indispensable benefits, and that a regime of
restraint, even if imperfect, is preferable to a complete
absence of restraint. He emphasized the need for multiple
information sources, maximization of public confidence,
reliance upon NGO input, and separate and independent
government institutions. He expressed concern over the
increasing prevalence of academic and industrial
partnerships, which bring into question the role of
independent science. He called for cost-benefit analysis of
such efforts.

OVERVIEW OF THE PRECAUTIONARY PRINCIPLE

Calestous Juma, CID, facilitated discussion on this session
addressing the origins and evolution of the precautionary
principle.

Panelists: Konrad von Moltke, International Institute for
Sustainable Development, highlighted the importance of
"institutions," as distinguished from "organizations." He
stated that precaution is an institution of governance and
that such institutions are the building blocks of society
serving as the "rules of the game" used to make decisions.
He emphasized that the scientific basis of all modern
environmental policy involves some degree of uncertainty,
and that governance procedures to address this uncertainty
are essentially the institutions of precaution. He noted
that the international debate on the precautionary
principle has thus far largely ignored this institutional
dimension, and in considering the precautionary principle,
he supported efforts to better understand the institutions
of precaution through which governments move from science
to policy. He stated that such an institutional analysis
should account for the public policy differences across
countries, highlighting the institutional differences among
OECD countries, sub-Saharan countries and international
institutions.

Von Moltke pointed out that some developing countries and
international institutions must make decisions from a point
of ignorance, noting that even with scientific data,

governments are still faced with uncertainty. He
highlighted several international treaties incorporating
some form of precaution (e.g. European Convention on Long
Range Transboundary Pollution, fisheries agreements, the
Cartagena Protocol), while noting that some had not
operationalized the principle. He also noted that Article
XX of GATT, which includes environment-related exceptions
to GATT rules, was written in the 1940s at a time of
scientific uncertainty, and is inadequate for dealing with
conflicts coming before the WTO today. He concluded that an
institutional approach will help reveal how the
precautionary principle or approach is employed in
countries actively engaged in developing environmental
policies. He noted that recognition of differences in
institutional structures can result in different answers to
identical questions.

Carolyn Raffensperger, Science and Environmental Health
Network, supported application of the precautionary
principle and underscored the unprecedented and potentially
catastrophic present magnitude of human-induced change on
the land. She identified common elements of the principle
in international treaties, including threat of harm, lack
of scientific certainty and action to prevent harm, while
also noting its expression in both active and passive
formulations. She cautioned against confusing precautionary
action with the precautionary principle. She listed other
elements modifying the principle in international
agreements, including cost effectiveness, rectification of
environmental damage at the source, the polluter pays
principle, cooperation in implementing commitments and
inclusion of improvement efforts in management frameworks.

To operationalize the principle, Raffensperger proposed
four provisions: people's duty to take anticipatory action;
burden of proof on the proponents of a technology;
examination of a full range of alternatives; and open,
informed and democratic decision-making, including affected
parties. She highlighted the principle's use as a belief,
regulatory tool, ethical directive and overarching
principle, and suggested that the principle be integrated
within the formation of research agendas as opposed to at
the end of a product's pipeline, which would significantly
alter economic implications. Regarding the approval of new
technologies, Raffensperger suggested using ongoing
monitoring activities, performance bonds and alternatives
assessment. She concluded by noting, inter alia, that the
principle: is not optional in view of the magnitude of
potential damage; requires more and different science;
employs ethics, as well as science; and is now a public as
well as an academic debate.

Discussion: Questions concerning the license to invoke the
precautionary principle when the threat of harm is imagined
or hypothetical were raised. Von Moltke said it would be
helpful to view the precautionary principle as "embedded"
in other institutions, noting their inadequacies. Some
participants commented on judicial interpretations of the
principle, with one noting that some legal systems can
interpret the precautionary principle and questionable
levels of threat literally, and that in Brazil this has
stalled the use of GM crops since 1998. Several
participants disagreed with Sachs' comments on the EU's
opposition to biotechnology and lack of independent
science, asserting that the EU was not trying to prevent
free trade or disavow independent scientific study and
noting that the EU's concern for health and environment is
a cultural characteristic. Some participants requested
clarification of the idea that the precautionary principle
is new and distinct from the traditional practice of risk
assessment. Sachs responded that he viewed the
precautionary principle as a regulatory mechanism and noted
that risk assessments are undertaken continually in
decentralized ways within many institutions.

One participant, emphasizing the difference between risk
and alternatives assessments, stated that risk assessment
for biotechnology should start with goals and progress
through a full range of options rather than limit
alternatives to a few bad choices. Sachs concurred that
decentralized decision making is essential and noted that
many different interpretations of risk assessment exist.
Several participants advocated balancing the risks of
innovation with those of stagnation. One participant raised
ethical concerns about using unproven scientific "facts"
and representation of developing country needs by developed
countries. Another participant asked how the scientific
community could receive more public support, and another
suggested increased spending where public support is
needed.

BOOK PRESENTATION AND DISCUSSION: PANDORA'S PICNIC BASKET

In an evening dinner session, Alan McHughen, genetic
engineer and author of Pandora's Picnic Basket/Consumers'
Guide to GM Foods, explained the process used to write the
book. He noted that it is generally based on questions
posed to him by the public. He noted the extremes on both
sides of the biotechnology debate, remarking that positions
have often hinged on bad science and/or false assumptions.
He added that increased public scrutiny of biotechnology is
generally a positive development. He stressed the need for
a common understanding of the precautionary principle to
avoid self-serving, and ultimately conflicting, methods of
application. He emphasized the need to look at the current
status quo in terms of techniques that biotechnological
methods could replace, noting that many conventional
activities present greater threats to the environment and
human health, yet are not subject to the precautionary
principle.

McHughen then compared the Canadian regulatory process for
approving a conventionally-bred variety of flax and a
genetically modified variety, noting an almost excessive
burden of additional information requirements for the GM
crop despite a difference only with regard to tolerance of
herbicide residues in the soil. He thus argued for specific
examination of the variety of biotechnological
applications, as opposed to blanket policies, and called
for clarification regarding misconceptions around some of
the alleged health and environmental effects of GM
products. He closed by noting that biotechnology and its
products are a fact of life and the market, and that
efforts should now focus on how to moderate and minimize
their hazards.

Discussion: Responding to a question about the most
erroneous assumptions encountered regarding biotechnology,
McHughen cited a common misperception that existing
cultivars of plants are "natural," noting that most food
products are modified in some fashion and little remains
that has not been altered by humans. He also highlighted
the belief that transferring genes across species was never
intended by nature and stated that such gene-flow is a
common, natural occurrence. Regarding a comparison of the
potential danger of biotechnology to nuclear weapons,
McHughen replied that biotechnology is simply a tool that
can be used for good or bad and that it may require more
stringent guidelines or regulation. Responding to comments
about developing a better understanding of biodiversity
before promoting biotechnology, he noted that such
knowledge will never be complete and that conditioning
biotechnology's development on this requirement would
effectively kill it. Discussion also highlighted
differences between the European and North American
scientific communities; the former being more isolated, and
as a result besieged by the public, whereas the latter
generally maintains more open communication. One
participant noted that plants, animals and even humans
share many genes in common, and that living organisms have
internal means of keeping their genomes intact even in the
face of gene transfer.

CONCEPTS AND DEFINITIONS

Kim Waddell, National Research Council, USA, chaired the
session outlining key concepts and definitions used in the
discourse on the precautionary principle.

Panelists: Marc Saner, Carleton University, Canada,
outlined three Western ethical traditions, focusing on:
character or attitude, rules to guide actions
(formalistic), or goals to guide actions (contextual). In
regulatory affairs, character ethics would employ the best
people to produce the best possible science. Rules ethics
would produce a consistent framework providing a basis for
sound science. And goals ethics would mandate flexibility
in an otherwise clear framework for sufficiently accurate
science. In mapping these traditions onto the precautionary
principle: character ethics expresses the view that an
attitude of precaution is virtuous; rules ethics implies
that we must make our existing rules more stringent; and
goals ethics serves as a tool to complement balancing
required to select best actions. Applied to stakeholders,
those who desire systemic change may focus on character,
those who wish to maximize transparency and consistency
might choose rules, and "wise" decision-makers would likely
focus on goals.

Practical implications of applying these traditions to the
precautionary principle would require changes to
regulation. This presents the problem of uncertainty, where
it becomes difficult to agree on character, action may miss
the target, and goals are uninformed. Saner suggested
either maintaining a standard approach or developing
alternatives that recognize implicit value assumptions and
the limited scope of regulatory science. He concluded by:
asking whether there are any ethical imperatives and a
place for discourse ethics; citing science as a risk
assessment of the second order; and advocating a broad
conception of the precautionary principle as a call for
change in attitude, prescription for formalistic action and
a call for contextual action to help conserve its ideal
meaning as initially conceived.

Julian Morris, Institute of Economic Affairs, United
Kingdom, gave a brief history of "risk," noting that taking
risks can be beneficial and that all human activity entails
some element of risk. He stated that one should not attempt
to eliminate risk, but should instead aim to strike a
balance between risks taken, acknowledging that some risk
should be avoided (e.g. nuclear war). The question that
should be asked is "how do we make decisions on risks that
are uncertain?" He stated that most definitions of the
precautionary principle fall into two broad classes: strong
- take no action unless you are certain that it will do no
harm; and weak - lack of full certainty is not a
justification for preventing an action that might be
harmful. He noted that governments have generally employed
the weak version. For example, he said that despite
scientific uncertainty, the EC banned hormones used for
animal growth promotion on the grounds that "their safety
has not been conclusively proven." By contrast, consumers
and environmental NGOs have typically employed the strong
formulation to justify their demands for restrictions and
bans. He quoted Greenpeace's assertion: "Do not admit a
substance unless you have proof that it will do no harm to
the environment." He criticized this mindset as leading to
the damage of GM field trials in the UK, which has
discouraged funding of biotechnology research.

He highlighted the following problems with the definition
of the precautionary principle in the Rio Declaration (see
BACKGROUND): the meaning of "threat" is unclear; "damage"
needs to be defined and distinguished from mere "change"
the assumption that all change (and hence all damage) is
irreversible; "seriousness" is a subjective concept; and
there will always be scientific uncertainty. He suggested

that the biotechnology industry needs to promote consumer
confidence. In closing, he remarked that "everyone likes
progress, but no one wants change," which is a
contradiction that must be reconciled.

Anil Gupta, Indian Institute of Management, discussed
institutional approaches to the management of risks, their
externalities and how the poorest people address such
risks. He noted that the poorest people generally live in
the highest areas of risk and are often employed in the
riskiest types of activities. Households survive by taking
risks and coping with their consequences, often while
improving their capacity to deal with uncertainties in the
future. He stressed that the precautionary principle's
application depends on a number of social and other
attributes, and that different segments of society require
different levels of assurances depending on the type of
technology and levels of access. He noted the need to
consider whether such risks are reversible, immediate,
accumulative, source-identifiable, localized, insulated or
recombinant. He called for assessment of such traits in
tailoring specific institutional responses, discouraging
blanket approaches. He contrasted the public acceptance of
GM medicines, such as insulin, with public concern over GM
crops.

Gupta also proposed a model to appraise technologies
through categories of access, assurances, ability and
attitudes, and provided examples within India regarding
local application of herbal pesticides and a national
effort to address famine through the introduction of hybrid
seeds during the green revolution. He also called for a
fair chance for competing technologies, voices and visions
of the future. He closed by stressing the need to integrate
the six-"Es" (ethics, efficiency, excellence, environment,
equity and education) into risk assessment and management.

Discussion: One participant asked Saner why risk
identification is not a scientific task, and why
transparency is more critical to less developed countries
than to developed ones. Saner replied that he wanted to
separate facts and value, noting scientists are not always
qualified to make value judgments regarding the environment
and high levels of risk assessment. He said transparency is
important for everyone, but he was referring specifically
to developing country government officials. Another asked
whether institutional frameworks dictate levels of risk,
advocating building conflicts of interests into the system
to avoid falsely elevating the virtuous aspects of his
theory. Saner agreed, saying he wanted to show three
independent options, their distinctions and
interconnectedness without dictating a hierarchical
framework.

Regarding the debate between precaution and innovation, one
participant suggested that scientists and economists should
collaborate to build models on risks for more effective and
objective evaluation. Saner responded that scientists and
economists agree that risk management is value-laden and
that hidden value assumptions must be under the control of
managers, not technicians. When asked about comparisons of
alternatives and specific scientific qualities and
protocols (peer review, control, transparency) that would
improve decision-makers' ability to judge science, Saner
responded that this was hard to formalize and often
entailed errors and faulty methods.

A participant asked Julian Morris about his comment
regarding the shift in debate on genetically modified
organisms (GMOs) in Europe. He responded that those who
would benefit from GMOs would bring about a change in
views. Another cautioned against oversimplifying the
debate, noting the real dangers of improper use, the
resistance present in farming communities, and the
structure of interests that influences public perception.
One participant objected to Morris' comments on NGOs,
noting that most have been calling for better science and
raising valid concerns about gene-flow, transmutation, and
unintended consequences. Morris responded that he had
wanted to highlight concerns about fundraising, suggesting
that some NGOs shifted their focus from environmental to
consumer issues to raise public fears and thereby mobilize
funds.

SCIENTIFIC AND TECHNICAL FOUNDATIONS

Andrew Spielman, Harvard School of Public Health,
facilitated the discussion in this session addressing
scientific and technical foundations of precaution as used
in risk management.

William Leiss, Royal Society, Canada, discussed "risk
controversy," highlighting the following common features:
knowledge gaps; distrust of those who perform scientific
research, with less trust for industry and increasingly
less trust for governments, and more trust in NGOs;
difficulty in handling problems of uncertainty; intensive
dispute over risk assessment data; spin-doctoring; and poor
risk communication, where no one takes responsibility for
ensuring that the public is well informed. He challenged
the group to find a way to make risk controversy socially
useful, thereby ensuring a transparent process where the
public can reach informed decisions.

He illustrated two examples regarding the role of
scientists in addressing risks and the precautionary
principle: the monarch butterfly study, where many
scientists noted flaws in such studies; and the case of
pesticides, where some scientists, who previously asserted
their safety, later sought their elimination. He noted that
this reflected a fundamental question about the credibility
of science and its push for GMOs, and wondered whether
biotechnology is at the same point where pesticides
technology was in the 1950s.

Klaus Ammann, University of Bern, stressed three central
themes: people should be able to decide which technology
they want to adopt; progress is not always found in new
technologies; and corporate and eco-imperialism should be
avoided. He noted preference for the term precautionary
approach over precautionary principle, as "approach"
reflects an iterative planning process adaptable to
changing needs and conditions. He noted different kinds of
knowledge (factual, deontic, explanatory, instrumental and
conceptual), asserting that no single actor has all
relevant knowledge.

Ammann then listed four problematic tendencies of the
actors involved in the current debate on biotechnology:
industry people tend to live in a corporate atmosphere of
euphemism and perfection, prefer deontic knowledge and have
difficulties understanding external criticism; scientists
are often na´ve, believing in factual knowledge alone, and
manipulate non-scientists by selecting appropriate facts;
some NGOs have evolved into powerful protest industries and
are not interested in science; and the public often does
not know whom to believe and does not understand that
criticism and acceptance of biotechnology is a demanding
cultural process.

He called for a comparison of biotechnology with organic,
integrated and classic farming practices and suggested that
biotechnology: evolve towards precise applications, adapted
to the local needs of farmers and the environment;
eliminate gene-flow where necessary; and attempt to mimic
biodiversity's natural processes. He concluded by calling
for a focus on the advantages of all farming technologies
and their potential integration.

Gary Marchant, Arizona State University College of Law,
USA, argued that the precautionary principle is the "wrong"
answer to the "right" question of how to prevent harm to
human health and the environment before it occurs while
recognizing the inherent uncertainty in predicting risks.
He stated that the precautionary principle is a reactionary
response that neglects judgment of substantive merits and
inherently contains many dimensions of risk that should be
recognized. He noted that risk assessment has historically
dealt with the ambiguities of, inter alia, degree and level
of risk, data requirements for demonstrating safety, risk
trade-offs and type of action required. Until there is
agreement on these ambiguities, he stressed that there
cannot be consensus on the precautionary principle.

He noted that the intentional ambiguity of the
precautionary principle is designed to challenge the status
quo of political power, ideology and environment. In asking
who decides what a word means, he identified two levels of
arbitrariness: to which problems does the precautionary
principle apply, and when applied, what does it actually
mean? Stating that US courts are guilty of arbitrary and
capricious review, he called for determinate binding
standards based on criteria defining how clear an agency
must be to be understood. Without a limiting principle, he
said, results can become absurdly restrictive.

Discussion: One participant criticized those invoking the
principle to call for a total ban of DDT, as they fail to
appreciate DDT's contributions in controlling malaria. He
asserted that the principle is usually invoked by elites in
rich countries, which is a form of eco-imperialism. Ammann
asserted that factual knowledge of biotechnology alone is
not enough. Noting that the public is often misinformed,
Ammann proposed concentrating on minimum standards of risk
instead of public determination of acceptable risks.
Another participant said that the precautionary principle
would not work in the US, given its government and policy
structure, even though it could work in Germany and perhaps
the rest of the international community. It was also
suggested that the biotechnology industry was prospering
based on the ignorance of the public. Others suggested
promoting cultural acceptance of institutions that promote
biotechnology and the precautionary principle rather than
acceptance of the technology itself.

PARALLEL SESSION: NATIONAL EXPERIENCES

Michael Fisher, Massachusetts Institute for Technology,
USA, facilitated this session on the presentation of case
studies and national experiences with risk assessment,
management and the precautionary principle.

Panelists: Luiz Antonio Barreto de Castro, Brazilian
Enterprise of Agricultural Research, illustrated Brazil's
complex history of biotechnology and biosafety. He
emphasized that new technologies soon will only be limited
by those boundaries set by regulators and ethicists. Noting
the increase in biosafety regulations, he described a
complex web of interactions and consequences that reached
beyond biosafety issues to include worldwide agrochemical
markets, noting that the global fertilizer market is rising
while herbicide use is declining, which affects decisions
made about GM crops. The Brazilian biotechnology industry
has seen an increase in patents, enactment of patent laws
limiting technology, a ban on commercial use of
biotechnology since 1998 by the National Technical
Biosafety Commission (CTNBio), and acquisition of seed
companies by gene companies. The CTNBio is operating its
risk assessment and monitoring strategies at an
experimental and commercial level, using the precautionary
principle in authorizing field releases on transgenics.

He stated that PROGENE, the genome program of the Brazilian
environmental agency EMBRAPA, will operate as a network for
the identification, characterization, transfer and
expression of genes for agriculture. He emphasized that the
precautionary principle in Brazil is taken literally by
judges, so that no supporting scientific evidence is
necessary, and the argument that more testing is necessary
is always effective. As judges can always find scientists
who disagree, he stressed that the issue is now political.
Noting that such criticism of GMOs is so disproportionate,
he asked who ultimately benefits from delaying plant
biotechnology.

Responding to a question on the problem of distribution, de
Castro replied that Brazilian agribusiness must produce
more than they actually use on the same amount of arable
land in order to meet demands, noting that science will not
resolve social problems in general. Another asked whether
someone in Brazil could put up a bond in order to
temporarily lift the biosafety injunction, as in common law
systems. The response was no.

Aarti Gupta, Yale University, USA, presented her field
study on precautionary decision-making for biosafety in
India. Her main theme was that despite the inclusion of
precautionary decision-making in the Cartagena Protocol,
the relevance for developing countries of precautionary
decision-making for biosafety remains under-examined.
Highlighting the Indian Environmental Protection Act
(1986), under which LMOs are regulated, she suggested that
language on regulation of substances that "may be or tend
to be" injurious to the environment could be construed as
precautionary. She noted that despite India's stringent
biosafety regulations, they have not been fully tested as
no LMO for use in agriculture has been commercialized.

She distinguished the status of transgenic crop field-
testing between the private sector and the public sector,
and gave examples of the status of transgenic crops in
contained use. She then elaborated on the institutions of
the decision-making process and suggested that decision-
making criteria for biosafety are based on "sound science"
as well as "socioeconomic considerations." She stated that
the information generated in risk assessment is very
similar to other national and international models such as
in the US, OECD and WHO. She submitted that efforts to draw
boundaries around decision-making criteria, such as those
contained in the Cartagena Protocol, will have little
practical consequences in the Indian context.

She noted that biosafety data is generated by the private
sector and provided to public regulators, who are
themselves scientists engaged in transgenic research, and
that there are still concerns about sharing confidential
information and the credibility of data. She also
highlighted the crosschecks in the biosafety governance,
monitoring and evaluation committee.

John Mugabe, African Centre for Technology Studies, Kenya,
gave an overall assessment of biotechnology development in
Africa, noting that many African countries do not have the
time or choices to reduce scientific uncertainty. He said
the debate on perceptions of risk and precaution assumes
that society perceives risk in a homogeneous way. He
observed that the debate has confused products of
biotechnology with the system through which they are
distributed, and that addressing food production in most
African countries requires technological as well as
structural solutions.

He identified various levels of biotechnology development
in different countries: low levels of field testing are
being done in Ghana and Nigeria; Zambia and others are not
investing in biotechnology but are attracting foreign
testing; and countries like Tanzania have no investment in
biotechnology. South Africa has seen achievements in
biosafety, biotechnology risk assessment, and institutions
for risk assessment invoking the precautionary principle.
Tanzania has passive regulatory measures, while Egypt and
South Africa include policies addressing the precautionary
principle. He stated that countries investing in
biotechnology can move from the precautionary principle to
other regulatory policies, and South Africa, Egypt, Kenya
and Zimbabwe have science-based risk assessment that
includes local inputs. He stressed the point that countries
able to invest in GMOs have already developed appropriate
risk assessments.

Discussion: Regarding a question on how intellectual
property rights (IPR) allow the poor in India to benefit
from biotechnology, Gupta responded that the current Indian
patent law does not consider life forms and product
patents, although there are proposals to amend this law. It
was noted that regulatory data for GM crops is not as
easily accepted as for pharmaceuticals or agro-chemicals.
One participant suggested a correlation between countries
that have embraced biotechnology and their institutional
capacity to apply precaution and conduct risk assessments.
One participant questioned why NGOs have been more
successful in blocking GMOs in places like India and
Brazil, than in other developing countries. A Brazilian
participant suggested that it was because Greenpeace had
successfully managed to convince the judiciary of the
potential risk. Gupta said that in India the NGOs have not
been that successful and this is due to the fact that high-
level government officials support biotechnology.

PARALLEL SESSION: INTERNATIONAL EXPERIENCES

Jayashree Watal, CID, facilitated this session on the
presentation of case studies and international experiences
with risk assessment, management and the precautionary
principle.

Panelists: Piet Van der Meer, Ministry of Environment, the
Netherlands, highlighted his work with Central and Eastern
European (CEE) countries seeking entry into the EU and in
the process of adjusting their regulatory frameworks to
abide with EU directives on biotechnology. He noted that
biosafety frameworks need to include a regulatory
framework, an administrative system, decision-making
procedures and means for information dissemination.
Further, the process of decision-making is key to
implementing the precautionary principle and must address
three steps: assessment of whether procedural requirements
have been met; risk assessment on a scientific basis; and
taking a decision, which is a political issue. He stated
that risk assessment should address identification,
likelihood and consequences of hazards, including worst-
case scenarios. He provided examples of how such a model
could work for different types of antibiotic resistance
markers.

Van der Meer highlighted the need to find a common
understanding of the principle's application, recognizing
that participants in the debate have been approaching the
issue from different domains, levels of generality, stages
in the regulatory process and terminologies. He called for
assessment of the impacts and conceivable hazards of
existing alternatives, as well as further discussion to
clarify different conceptions of the principle's purpose
and its practical use.

Diego Malpede, Ministry of Foreign Affairs, Argentina,
discussed the national context of biotechnology in
Argentina, as well as its perspective on international
trade and environmental discussions relating to the
precautionary principle. He highlighted the national
benefits of biotechnology's application as well as
Argentina's regulatory structure, including its three
invocations of the precautionary principle regarding
proposed introductions of varieties of canola, corn and
sunflower. He noted a more cautious attitude by the
agricultural business sector since the Cartagena Protocol's
adoption and the sector's recognition of the need for
differentiated agricultural products to satisfy consumer
preferences. He added that Argentina has only authorized
commercial development of GM varieties already approved by
the EU in order to ensure the security of its international
markets.

In the area of international policy, Malpede noted common
fears that the precautionary principle could be used for
protectionist measures, thereby restricting access to
foreign markets. He stated that effective capacity-building
in developing countries is essential for the Cartagena
Protocol's success. He further reviewed the principle's
inclusion within the WTO's Agreement on Sanitary and
Phytosanitary Standards (SPS) and suggested that
precautionary action only take place: where relevant
scientific information is insufficient; on the basis of
available pertinent information; through efforts to obtain
additional information necessary for a more objective risk
assessment; and within reasonable timeframes for review. He
concluded by noting that regulatory guidelines for the
principle should consider: internationally agreed
principles; open and transparent functioning; rigorous
research, especially by independent bodies; no more
restrictions on trade than necessary; recognition that
ignorance is not equivalent to lack of scientific
certainty; and reasonable timeframes for decision-making.

Discussion: Participants posed questions on the principle's
operationalization. Van der Meer noted that it is basically
common sense, and Malpede said that Argentina's decision
not to commercialize products not already approved in
Europe was an application of the principle in economic
terms. Several participants stressed concern with the EU's
position, especially as expressed in a recent Communication
on the principle claiming that the principle could easily
be employed as a non-tariff trade barrier. One participant
requested a more explicit definition of the EU's use of the
term "sufficient certainty." One participant called for
more attention to trade concerns within the debate and
suggested a creative competition between trade and
environmental goals. Others noted that the European system
will simply take more time to work through the process
given complexities of internal policy formulation, and that
one of the points expressed in its Communication was to
avoid the principle's use for trade protectionism. One
speaker commended the EU for stating its position in
writing and called upon other countries to do the same as a
constructive step in the debate.

PARALLEL SESSION: POLICY AND INSTITUTIONAL IMPLICATIONS

Amanda Galvez, Facultad de Quimica, Mexico, facilitated
this session on the policy and institutional implications
on the evolution of national and international regulatory
regimes.

Ed Soule, Georgetown University, USA, spoke about
regulatory legitimacy and distinguished between weak and
strong versions of the precautionary principle. He defined
the weak version as being highly pragmatic, providing
regulators with some flexibility in determining relevant
factors and deciding on the importance of environmental
risks. The strong version is risk averse, limits regulators
to consideration of environmental risks and urges
prohibition of the commercialization of novel technologies
until they are proven safe. He suggested that in the weak
version, risk is a valid concern in domestic settings and
may necessitate preventing or regulating particular
technologies. He also suggested that under this model
economic and social considerations are taken into account.
However, in the international arena, differences in
industrial profiles lead to and invite selfish behavior of
domestic industries. If the weak formulation is embraced,
it would be a feeble addition to the US regulations
concerning genetically modified pest-protected plants. He
suggested that the Cartagena Protocol introduced weak
precautionary language into an international trade
agreement and was concerned that this would encourage
production of environmentally risky agrochemicals.

In the case of the strong version, risk is expected to
trump all other concerns. It is sometimes argued that
uncertainty of risks supports the principle's risk-averse
stance. He rejected this proposal, noting the contradiction
that one can know enough about GM crops to prevent their
commercialization, while not knowing enough to compare
their risks to agrochemicals in order to decide which
technology is preferable. He suggested that the choice of
risks is a political or moral decision and that to preclude
either on the grounds of such uncertainty would be very
arbitrary.

Professor Philip Bereano, University of Washington, USA,
characterized this conference as an expression of the
political reality of the precautionary principle. Focusing
specifically on the US, he noted that risk assessment,
management and communication are political because
definitions are not clear or obvious and costs and benefits
do not fall equally on everyone. He discussed the
historical context of political regimes that have
effectively repressed the work of environmental activists,
and invoked images of purported democracy masking the
struggle for real and transparent processes in past and
present administrations. He reminded participants that
risks are subjective, and arise not because scientists try
to discover them but because the public encounters them. He
emphasized that people will react strongly if they believe
the risks of GMOs are being imposed upon them without their
consent, knowledge or an open and transparent process.

As for the ambiguity of the precautionary principle, he
reminded participants that the "reasonable man" standard
has been elaborated in the US legal system to accommodate
and employ many different interpretations quite
effectively. He stated that it is necessary to allow the
organic nature of law to define and perfect the meaning of
terms like environment and precautionary principle.

One participant saw the political struggle as a battle
between industry underestimating risks and NGOs
exaggerating risks, wondering which side is currently
getting away with the biggest exaggeration. In response,
Bereano noted that the NGO community generally addresses
possible hazards for further investigation, as opposed to
claiming risks.

On ways to achieve transparency, Bereano noted that issues
were more salient in Europe partially because of increased
tolerance of alternative views in high levels of
government, whereas in the US such opinions are dismissed
and consumer concerns are marginalized. One participant
noted the irony that the US is a participatory democracy,
while people in the UK do not generally engage in politics.
Another commented that she had served on a recombinant DNA
advisory committee and asserted that applications were made
public and the process was open. Bereano conceded that the
process was open but claimed that it was biased and
included an incestuous political struggle.

Parallels were drawn between biotechnology and computer
technology within the private sector, regarding the desire
for a public regulation process in guiding consumer choice.
Bereano responded that values beyond economic efficiency
mattered in a democratic process and that the analogy is
flawed, as computer technology does not pose a new
environmental threat through their ability to reproduce,
mutate and migrate.

Gary Comstock, Iowa State University, USA, began by quoting
the philosopher, Steven Truman, who said that "rationality
is not having a true set of beliefs; it is knowing when to
change your mind." He suggested that the principle's
formulation in the Rio Declaration implies that new
technologies should not be advanced unless there is
certainty that it will be safe for humans and the
environment. He suggested that this is society's expression
of risk aversion and that is why it has been codified into
international law and why the EU has invoked the principle
to justify its current moratorium on GM crops.

He asserted that a logical analysis of the principle
reveals two contradicting propositions: (i) We must not
develop GM crops, as some in the EU propose; and (ii) We
must develop GM crops. He therefore suggested that the
burden of proof is on the principle's defenders to explain
why its policy implications are not incoherent. He stated
that discussion should not focus on the principle, but
rather on the obstacles standing in the way of delivering
the potential benefits (e.g. improved nutritional content
and decreased environmental and health impacts). He
proposed the following questions: if biotechnology
advocates want to feed the world's hungry, why aren't they
putting more resources into alternative methods proven to
increase production; and what gives biotechnology's
opponents the right to take away the choice of using the
technology from people in other countries?

Discussion: There was insufficient time for a closing
discussion.

PARALLEL SESSION: REGULATORY IMPLICATIONS

William Leiss, Royal Society, Canada, facilitated this
parallel session addressing the implications of the
precautionary principle for existing regulatory practices.

Panelists: Andrew Apel, AgBiotech Reporter, presented his
ideas to unify the concepts of substantial equivalence and
the precautionary principle. Noting recent criticism of
both concepts, he stressed the need to develop a mutual
compromise among interested stakeholders. He noted that
substantial equivalence generally embodies the idea that
existing organisms used as food can provide a comparative
basis for assessing the safety of a similar product or
variety that is modified or new. He noted that substantial
equivalence allows for taking action in the face of
uncertainty, whereas the precautionary principle obstructs
further action under such conditions. Further, substantial
equivalence does not require absolute scientific certainty,
a virtual impossibility, to assess and make decisions about
potential risks. He noted that conventional food crops
produce toxins, carcinogens and other compounds and thereby
have their own risks, yet are still publicly accepted.
Through the use of substantial equivalence, such
conventional crops can serve as the baseline for assessing
GM varieties.

Apel did note that substantial equivalence is not equipped
to address developments that are so new that they cannot be
interpreted in terms of the status quo, at which point the
potential risks could be assessed through the precautionary
principle. He noted that the principle would thus be
subsidiary to substantial equivalence and that this is
consistent with the Cartagena Protocol. Finally, he called
for an assessment of the risks and dangers of existing non-
GM controls to their GM alternatives, suggesting the need
for further research on the impacts of herbicide
applications on monarchs in addition to work on Bt maize.

Mario Rodriguez, AgroBio Mexico, noted the tendency for the
debate to marginalize developing countries, by presuming
that they do not have expertise in ethics, applying
technologies, or developing regulatory frameworks. He also
noted that developing countries should not be treated as a
homogenous block, given the diverse range of economic
development and interest in biotechnology. He stated that
there is no precautionary principle as there is no general
consensus on its formulation, and instead supported the use
of longstanding principles such as comparative advantage,
non-discrimination and most-favored nation status. He
stated that technology is an important indicator of a
country's ability to derive national benefits and suggested
that using the precautionary principle to curtail
technological development would leave developing countries
disadvantaged in the global economy.

Rodriguez stated that the principle could not be integrated
into regulatory frameworks, given the inability to achieve
social consensus on development objectives. Alternatively,
he proposed concentrating on the role of biotechnology in
development, noting that developing countries that want
biotechnology generally have the appropriate institutions
to regulate it. He expressed concern that the principle's
use in the Cartagena Protocol would allow discrimination in
trade and lead to the development of trading blocks around
those accepting and rejecting biotechnology. He concluded
by noting that in the Mexican context, the country needs a
regulatory framework matching the US and Canada, given the
significant volume of trade with these two countries.

Discussion: Noting disagreement with Rodriguez on the
impossibility of integrating the principle into national
regulatory frameworks, one participant stressed the
sovereign right of countries to address uncertainty in
their own manner and suggested strengthening capacity
building to assist its integration. Another participant
questioned whether irradiated foods and non-dolphin safe
tuna would be considered substantially equivalent to their
counterparts. He stated that substantial equivalence does
not permit consideration of externalities and thereby
provides no better ground for decision-making than the
precautionary principle. Apel stressed the need to look at
differences in products and avoid other externalities.
Responding to a question on whether ethics should be
factored into such decision-making, Apel replied that such
concerns complicate the debate, which should be kept as
simple as possible. Rodriguez then questioned whether it
would be ethical to take a decision using a principle as
recognizably ambiguous as the precautionary principle. Some
participants emphasized the need to consider environmental
externalities, especially in the case of mega-diverse
countries such as Mexico. Finally, one participant called
for further examination of the ambiguities and inadequacies
within existing risk assessment procedures.

CLOSING SESSION

During the closing session, part