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Date:

October 17, 2000

Subject:

U.S. Under Secretary: MAKING GOOD ON

 

World Food Prize Speech
Under Secretary of State Alan Larson
Des Moines, Iowa
October 12, 2000
(As Prepared for Delivery)


MAKING GOOD ON BIOTECHNOLOGY’S GLOBAL POTENTIAL

I am deeply honored to join this distinguished group of world experts to
discuss the challenges and opportunities of agricultural biotechnology. I
thank Mr. Ruan for his vision in supporting the World Food Prize, Governor
Vilsack and the leadership of the Iowa legislature for making this
symposium possible and my old friend Ken Quinn for putting together a
superb program.

We are all indebted to Nobel Laureate Norman Borlaug for a lifetime
dedicated to agricultural research. We also thank you, Dr. Borlaug, for
conceiving of the World Food Prize as a way to honor outstanding
scientists like Dr. Vasal and Dr. Villegas. Their hard work and ingenuity
in developing quality protein maize (qpm) and making the technology
available in developing country markets is a concrete demonstration of how
we can make technology work for the good of humankind.

We need more such examples. Despite magnificent advances in agricultural
productivity during the last quarter century, some 800 million people are
still undernourished. Over 200 million of them are children. In fifty
years, the world’s population could grow to 10.7 billion. For a
population this large to be adequately fed, the world will need to double
food production.

In the past, experimenters and scientists helped the world avert a
Malthusian disaster by improving the genetic characteristics of crops
through crossbreeding. Dr. Borlaug and others now conclude that the world
has reached the stage where conventional cross-breeding will not be
enough. Modern biotechnology will be needed to improve crops sufficiently
to meet future food requirements.

Biotechnology provides unique opportunities to increase the quantity,
quality and reliability of food supply. These gains can be achieved with
potentially less need for pesticides and herbicides, less demand on scarce
water supplies and less pressure to use ecologically sensitive land.

Biotechnology holds particular promise for developing countries and for
poverty alleviation. Despite considerable progress during the past
quarter century, many countries, especially in Africa, have been unable to
achieve sustained gains in agricultural productivity. Increasing farm
productivity will raise the incomes of the rural poor and free up workers
to support growth in the manufacturing and service sectors. Raising
agricultural productivity will be critical in any effective strategy for
achieving sustainable growth and poverty alleviation in Africa, and to
continued progress in the rest of the developing world.

Notwithstanding its great potential for good, agricultural biotechnology
faces formidable challenges and an uncertain future. These challenges are
not primarily scientific or technological; rather, they are essentially
political. Overcoming these challenges will require cross-fertilization,
not just of seeds but of minds. I am excited about this conference
precisely because it is bringing together the sort of diverse expertise
that can help public policy find a way forward.

Let me highlight the public policy challenges that must be addressed if
agricultural biotechnology is to achieve its full potential.

* First, here in the United States we must ensure that our food safety
system continues to be the world’s best.

* Secondly, all of us must work to encourage the development of sound,
science-based food regulatory regimes throughout the world.

* Third, we must take a comprehensive view of the impact of new
agricultural technologies – including biotechnology – on the environment.

* Fourth, with leadership from the scientific community, we must find
better ways of communicating with the public on issues of risk assessment
and risk management.

* Fifth, all countries must recognize their stake in maintaining a
rules-based trading system for agriculture, including trade in biotech
products.

* Sixth, we must make a major concerted effort to ensure that developing
countries have the capacity to use biotechnology to address their pressing
developmental needs.

* Finally, our approach to the generation and dissemination of knowledge
in agricultural biotechnology must take full account of two things -- the
need for strong intellectual property rights protection to encourage
private sector research and innovation, and the value of an appropriate
public sector role in promoting basic science as well as institutions and
policies favorable to agricultural development.

Fair and Transparent Regulatory Processes
The United States benefits from a science-based, professional and
independent process for ensuring food safety. This system not only has
protected and reassured consumers at home, it helped make the U.S. a key
contributor to global food supplies by maintaining the confidence of
consumers and regulators abroad. Such trust is a precious asset that we
intend to preserve.

During the last year a number of scientific reports and conferences
reaffirmed that the biotech foods now on the market are safe. I was
particularly impressed by the study by scientists from the Third World
Academy and six national academies of science: the U.S., U.K., Mexico,
China, India and Brazil. These consensus findings reaffirm the basic
integrity of the United States approach to food safety. We cannot,
however, rest on our laurels. As technology advances, we will need
continually to monitor food safety and refine regulatory processes.

We also must rigorously investigate any lapses in compliance with food
safety regulations, including the apparent presence in taco shells of
biotech corn not yet approved for human consumption. We must also do so
transparently. At the same time, we need to establish workable
distribution systems and timely, science-based approval processes that
facilitate compliance and help us understand any relevant risks. We
should all be careful not to create undue regulatory burdens or
liabilities where relevant risks cannot be found or are truly minimal.
But where we have effective rules to address food safety risks, we must
vigorously enforce them, while being honest about any lapses and potential
consequences.

Some consumers may decide to avoid biotech products, despite their
safety. If such a market develops, industry will want to serve it. The
federal government stands ready to facilitate industry efforts to develop
truthful and non-misleading voluntary labels. We also welcome industry
initiatives to provide information about the characteristics of the food
products, for example, through toll-free hot lines and internet-based
information sites. Our goal is to maintain consumer confidence worldwide
that American food products set the standard for safety and quality. Let
me be clear, if we find any U.S. food product unsafe for general
consumption, we do not and will not allow it to be sold, period.

To meet consumer expectations, industry probably will need to make more
progress on the segregation of different crop varieties. Being an Iowan
with a lifelong interest in agriculture, I have some idea of how difficult
it will be to prevent incidental co-mingling in bulk shipments.
Procedures related to biotech need to be tightened and improved based on
realistic tolerances and trustworthy testing procedures. Market demands,
science and risk assessment and food security should be part of that
equation.

Fostering Science-based Regulatory Systems Abroad
Encouraging the adoption of transparent, science-based food safety
regulatory regimes worldwide is a key policy challenge. In developing
countries there is a need to build capacity to implement science-based
food safety systems. We are trying to help through engagement by the U.S.
Agency for International Development, the U.S. Department of Agriculture
and the Food and Drug Administration. This is a particular struggle in
Europe, however. At first, the politicization of food safety regulation
made EU governments too slow to take action to protect the public. As a
result, government mishandled public health issues related to
dioxin-contaminated feed and "mad cow" disease. Many Europeans lost
confidence in their governments’ approach to food safety.

Now there is a backlash in Europe, and it threatens to spill over. Food
regulation there is more politicized than ever, but now it is marked by
undue and unscientific fears of new technology and a paralysis in
science-based food safety approvals and regulation. Despite early
positive efforts by some European authorities, political parties and
governments now invoke the so-called "precautionary principle" to justify
decisions that have no scientific foundation.

European Union member states have imposed a de facto moratorium on imports
of biotech corn varieties –- many grown right here in the Mid-west --
already approved as safe by European scientific authorities. Italy
recently banned four types of biotech corn already approved for EU
consumers. EU science bodies have stated that Italy’s move was based on
no credible scientific evidence of any human health risk, and yet Italy’s
law still stands.

Meanwhile, EU politicians are producing a blizzard of new regulations on
biotech that have little or no basis in science. These regulations raise
food supply costs with little apparent benefit to food safety. They are
arising so fast that we literally cannot keep track of them, and there is
little advance discussion. At the same time, there has been little
progress on EU President Prodi’s sensible idea to establish a Europe-wide
food safety regulatory body modeled in large measure after the U.S. FDA.

Clearly, we will all need to work hard to avoid new food regulations that
restrict consumer choices and raise costs, that are not grounded in
scientific risk assessment, and that almost certainly violate WTO rules.
WTO rules, after all, are fully consistent with –- and certainly allow –
food safety protection. They also protect us all from ad hoc and
unwarranted trade barriers, which history has proven can cause real harm
to peoples’ prosperity and aspirations. WTO members have all agreed to
abide by these rules, and developing countries are already struggling to
do so.

Many governments are considering imposing highly restrictive biotech
regulations. Japan, Australia and New Zealand all plan mandatory biotech
food labeling systems, though some consideration is now being given to
impacts on food supply costs. Yet, others are poised to join. Korea may
soon impose mandatory labeling on both processed and bulk biotech food
products. Saudi Arabia has rescinded a ban on biotech products, but will
require importers to stipulate in writing that they know of the potential
dangers of biotech foods, despite the scientific consensus that there are
none. This will clearly limit biotech shipments to Saudi Arabia, perhaps
sharply. Singapore is seeking government certification of all biotech
food shipments, again, despite their presumed safety.

Now we are hearing that European governments will seek to regulate and
restrict even biotech feed grain by, among other things, imposing onerous
traceability conditions where no known health risk of any kind has been
found. Many countries currently favor extremely low tolerances for the
presence of biotech, though credible tests at such levels are not now
possible. We are working with all of these governments to ensure that
their decisions take into account the science on biotech food safety,
impacts on food costs and security, and the full range of biotech
regulatory options.

The next year could be a crucial one for biotechnology in international
fora. The science-based Codex Alimentarius Commission on food safety will
address such important issues as labeling and the appropriate use of
regulatory precaution in cases where the science on both risks and
benefits is not conclusive. Codex is a critical technical forum that
brings together regulators and scientists from around the world to help
guide approaches to food safety regulation and trade. Deliberations
within Codex are becoming more politicized. We need the help of
independent scientists to ensure that this organization of over 150 member
countries and many NGOs continues its work to protect consumers based on
science and analysis, not politics.

Assessing New Agricultural Technology and the Environment
As we all look for a way forward on biotechnology and other new
agricultural technologies, it will be extremely important to look hard at
the risks they may pose to the environment. The consensus amongst
scientists is that any potential risks associated with biotech are
manageable. But there is more that remains to be understood than there is
with respect to food safety. At the same time, we all recognize the
substantial environmental impacts of current agricultural practices. Yet,
often we fail to consider the effects of new practices relative to that
baseline.

There is very good scientific work on the potential of biotechnology to
help protect the environment. Even some existing varieties require less
pesticide applications and involve lower losses from disease, storage, and
deterioration. Tthat means we need fewer resources to deliver a given
amount of food, and in turn that means less environmental impact.
Biotechnology is not the only new approach with potential environmental
benefits, but it is a promising tool that deserves to be tried, better
understood, and considered as part of our effort to feed an expanding
population sustainably.

The United States took an active part in helping to establish the
Biosafety Protocol, which aims to help protect global biodiversity. Our
support for protecting and preserving plant genetic resources is
longstanding and includes substantial work with developing countries. We
are therefore proud of our cooperation to shape a workable Biosafety
Protocol, and continue to work to ensure effective, science-based
approaches that support beneficial trade. Currently, the Protocol’s
implementing body is working on capacity building and information sharing,
with a strong focus on the internet-based Biosafety Clearing House.
Well-implemented, the Biosafety Clearing House mechanism will help
disseminate widely the available information on the environmental aspects
of approved biotechnology products.

Interestingly, some have suggested that the biotechnology’s very potential
creates strong incentives to protect and preserve genetic diversity.
Biotechnology is one of the clearest examples we have of the possibility
that even unremarkable species may embody genetic characteristics with
incredibly beneficial applications. We need to work together to
understand the environmental aspects of biotechnology, including its
potential benefits, in the context of existing practices and environmental
stresses, and weigh carefully the potential costs of foregoing its careful
development.

Better Communication on Risk Assessment and Risk Management
It is essential that scientists and businesses work with government to
communicate more effectively on the important issues of risk assessment
and risk management. These are integral parts of how policymakers and
regulators work to protect public health and safety while ensuring the
tremendous benefits of having a wide range of choices and innovations
available to consumers. The United States has over a century of
experience with regulatory precaution, and yet we are renowned for an
economy that provides abundant innovation and choice for our own
consumers, and consumers worldwide.

Unfortunately, too much recent rhetoric seems designed not to illuminate
but to obscure the real issues surrounding regulatory precaution. I am
especially concerned about the effort, led by Europe, to enshrine in
international law an intentionally ambiguous and elastic doctrine called
"the precautionary principle."

Any sensible person would agree that a sound regulation system should
incorporate precaution. When scientific evidence is incomplete or
contradictory, U.S. regulators seek to resolve the uncertainties. In the
meantime, they take measures to protect consumers until additional
pertinent information is available and more complete risk assessments are
performed. Our approach to risk management involves balancing the
potential advantages and disadvantages of alternative courses of action.
Our objective is to promote public welfare, not to minimize risk, as some
critics seem to prefer.

In contrast, some advocates of the precautionary principle focus only on
minimizing the risks of new technologies, and not at all on the benefits.
They are also highly selective in their focus; French groups that are
alarmed about biotechnology may be unconcerned about nuclear power,
unpasteurized cheese or even smoking, activities for which science has
identified clear risks. The call for absolute scientific certainty can be
a cover for unscientific decision-making; when the preconceived goal is to
impose a ban or restriction, no evidence of potential harm is too
threadbare and no risk too hypothetical to offer a justification. In
private, some senior European officials often admit that certain of these
decisions were taken on the basis of political expediency, not principle.

If we try to imagine governments making real efforts to minimize all risks
to their citizens, the incredible limitations that would be required on
individuals’ activities and choices, and the near complete lack of
reliance on their judgment, become apparent. When it comes to regulation,
as in life, there really is no riskless course of action and certainly no
way to establish with scientific certainty that risk is absent. We will
all benefit if we can develop a new vocabulary for talking about the
decisions regulators make as they seek to assess and manage risks.

Ensuring Stability in Agricultural Trade
A well-functioning international trade regime is of fundamental
importance to all countries. Agricultural trade is particularly
important: it contributes to food security by allowing market forces to
draw food production into the locations that have a comparative advantage
and by ensuring that consumers have access to the best products, the best
prices, and the widest choices.

A well-functioning agricultural trade system requires confidence between
producers and consumers and rules that are respected. The United States
has worked hard to build that confidence and respect those rules. We have
sought to demonstrate our reliability as an exporter not only by
maintaining high quality standards but also by assuring importers that
they can count on us for supply. As a matter of longstanding policy, we
are committed to avoid using export restrictions to deal with high
agricultural prices or short food supplies at home. Last year the
Administration went one step further and removed food and medicine from
the scope of our economic sanctions, even in the case of states we judge
to be sponsors of terrorism.

Food importing nations have obligations as well. One of these
obligations is to respect trade agreements and to refrain from restricting
food imports in a manner inconsistent with the provisions of the WTO’s
provisions on sanitary and phytosanitary standards. Since 1998, however,
U.S. corn exporters have lost some $200 million in sales annually because
the EU has not permitted the import of varieties of biotech corn that
already have been approved as safe by the EU. New measures under
consideration by the EU would seem to put at risk other substantial export
markets, including corn gluten.

Recognizing the sensitivity of European opinion, we have taken a
constructive approach worked out by President Clinton and EU President
Prodi. A group of senior officials from both sides is meeting regularly
in an effort to work out practical arrangements to restart corn exports
and to address wider market access issues. At the same time, we have
established a Consultative Forum composed of eminent persons from both
sides of the Atlantic to address the areas of concern that now confront
agricultural biotechnology. Dr. Borlaug is one of the 10 American
participants in the Consultative Forum and I am looking forward to hosting
a lunch for the entire group tomorrow in Washington on the occasion of
their second meeting.

It is important that this collaborative effort bear fruit. The United
States already is concerned about Europe’s refusal to date to comply with
WTO rulings that have found EU programs on beef and bananas to be
inconsistent with the WTO. Agricultural trade tensions are likely to rise
as we continue negotiations under the built-in agenda of the Uruguay Round
and once we launch a new round of multilateral trade negotiations,
especially if low commodity prices persist. The United States, supported
by other farm exporters and by many developing countries, will seek to
eliminate agricultural export subsidies and dramatically reduce
trade-distorting domestic subsidies, and protective tariffs and quotas.
These are precisely the policies that Europe has used to protect its
farmers from competition.

Unless we can re-establish a predictable rules-based trading regime for
agricultural, including for biotech products, we run the risk of
proliferating trade disputes. It would be difficult to confine such
disputes to agriculture. I am hopeful that there is good will in many
quarters in Europe to work through these problems, but time is of the
essence. The December 18 US-EU Summit will be an important milestone at
which we need to show real progress on biotechnology.

Helping Developing Countries Benefit from Agricultural Biotechnology

Part of the resistance to biotech crops arises from a distrust of large
corporations and a resistance to globalization. Some feel that
biotechnology is suspect because it has been developed largely by the
private sector and has found its first uses in developed countries.

Most developing countries do not see it this way. The report I cited
earlier by seven academies of science, including five from developing
countries, drew attention to the important role of biotechnology in giving
developing countries tools for feeding their people. In a recent opinion
piece in the Washington Post, Nigerian Minister of Agriculture Adamu
criticized anti-biotech groups in developed countries, saying, "We do not
want to be denied this technology because of the misguided notion that we
don’t understand the dangers or future consequences. We will proceed
carefully and thoughtfully, but we want to have the opportunity to save
the lives of millions of people and change the course of history in many
nations."

The international community must make sure that enlightened leaders like
the Nigerian Minister get the help they need to secure the benefits of
biotechnology for their countries. The Green Revolution succeeded
precisely because the international community helped such countries as
Mexico, India and China to make the new varieties and techniques work for
them.

Good efforts are underway. USDA and USAID have programs to promote
cooperative research and technology development, and to help educate
developing country officials on biotechnology. USDA’s Agricultural
Research Service shares biotechnology germplasm with developing countries.
USAID spends over $7 million a year, often in cooperation with U.S.
universities, on supporting biotechnology development and technology
tranfer, primarily in Africa. USAID also is providing help on regulating
biotech appropriately, based on science. The Consultative Group on
International Agricultural Research is doing valuable work on adapting
biotechnology for developing countries, supported by participants such as
the Rockefeller Foundation.

There are many other groups and institutions involved in adapting
biotechnology and other new approaches for use in developing countries. I
am concerned, however, that compared to the task before us, this
international effort is under-funded and not receiving adequate priority.
I hope we can all cooperate further to enhance agricultural productivity
in developing countries, including through biotechnology.

Public-private partnerships must be part of the answer. One encouraging
example is the cooperation of Monsanto, USAID and the Government of Kenya
to develop a disease-resistant sweet potato. This will likely be among
the first genetically-engineered crops tested in sub-Saharan Africa. Not
for profit organizations have a vital role; the Rockefeller Foundation has
been instrumental in the development of "golden rice," a crop that combats
vitamin A deficiency and could save hundreds of millions of children from
blindness and other serious health problems related to the deficiency.

Developing and Disseminating Useful Knowledge

Privately funded research and development is a powerful force for
innovation. In the last two decades, capital markets have deepened and
improved their capacity to support innovation. For these markets to work
well, there must be a sound framework of intellectual property rights
protection to ensure an economic return for those research and development
expenditures that generate useful innovations.

These considerations may help explain why some of the first commercially
available biotech products were produced by American farmers, particularly
the corn and soybean farmers of the Midwest. Farmers here are used to
innovation and attentive to the cost-savings these crops offer by reducing
the need for herbicides and pesticides, for example.

We will need to think hard about whether this private sector model will
work everywhere. To be sure, as an economist, I believe the laws of
economics operate in all countries. If there are gains to be had from
developing a rice variety tolerant of brackish water, I see no a priori
reason why economic incentives should not play a role in stimulating the
innovation.

At the same time, we need to be aware that in many developing countries,
markets work imperfectly. Prices or information may be controlled, credit
markets may be weak or non-existent and land tenure may be insecure.
Potential investors may fear that intellectual property rights may not be
protected or they may simply find that the costs of developing adequate
information about fragmented developing country markets are too high. In
short, for some businesses it may be more attractive to concentrate on
products produced by developed country farmers.

I am inclined, therefore, to believe that there will also be an important
responsibility for the public sector and the not-for-profit private
sector. Public support for basic scientific knowledge is a
well-established role. There may also be a case for using public funds to
support research targeted on specific needs of developing countries and
for developing local R and D capacity in these countries.

Conclusion: Making Good on Biotechnology’s Global Potential

The State Department was recently named the Harry S. Truman Building. We
are proud to be bearing the name of the President who presided over a
remarkable period of American foreign policy: the conclusion of World War
II, the formation of NATO, the launch of the Marshall Plan and the
recognition of the state of Israel, to name just a few.

At a recent ceremony at the State Department, the historian Michael
Beschloss commented on how fortuitous it was that the man from Missouri,
Harry Truman, had replaced Henry Wallace as Franklin Roosevelt’s Vice
Presidential running mate in the 1944 election. Wallace, Beschloss
argued, would have been unprepared by background and temperament for the
consequential decisions our Nation faced between 1945 and 1952. I will
leave it to John Culver, author of a fascinating biography of Wallace, to
tell you in his presentation tomorrow whether he agrees with that
contention.

My point simply is to stress that in addressing our foreign policy
challenges of today, we need to bring forward skills and characteristics
representing the best of both Truman and Wallace. During the last week,
the President and the Secretary of State have devoted their energies to
consolidating a victory for democracy in the Balkans and preserving the
hope of peace in the Middle East: these are tasks reminiscent of the
traditional foreign policy challenges Harry Truman faced so squarely.

At the same time, Secretary Albright has consistently emphasized the
prominence in our foreign policy of economic and agricultural issues such
as biotechnology. While they sometimes are less newsworthy than the
crisis of the day, how they are managed can have far-reaching
consequences. This is why, after a meeting with Iowa farmers last year,
the Secretary of State asked me to establish an Advisory Group on the
international aspects of biotechnology to actively seek ideas and support.
And that is why, in crafting a successful American foreign policy for this
century, we should seek inspiration from the vision of Henry Wallace and
the courage of Harry Truman.

Thank you. I am sure your deliberations will bring us closer to ensuring
that biotechnology makes good on its global potential.

(source: "Hauser, Timothy P" )