Washington, D.C.
July 13, 1999

"Good afternoon. Thank you for coming.

"Let's think about this hypothetical situation for a moment: Let's suppose that today's salad was made with the new carrot from Press Club Farms, Inc. Farmers grow the new carrot on fewer acres because it yields more, and it's less expensive because it does not require any fertilizers or pesticides and can be harvested totally mechanically. In addition, it has more vitamin A & C than traditional varieties and stays crisper longer and keeps its fresh taste longer.

"But, because this carrot does not require as much labor, the farmers have had to lay off hundreds of employees. While it does not require any chemicals to flourish, this new carrot does affect the environment by making it difficult for other crops or plants in close proximity to survive. And though it's cheaper to begin with, it's only available from one company, which could result in a considerable premium over regular carrot seed.

"And what's the secret to this hypothetical new carrot? It's the latest advance from biotechnology -- produced with a gene from kudzu, an invasive weed.

"Sound far-fetched? It probably shouldn't: Remember the flavor-saver tomato? How many of you have heard of the so-called terminator gene which can keep a plant from reproducing? Today, nearly half the soybeans in the U.S.  the stuff that is crushed and made into salad and cooking oil and that feeds most of the livestock we grow are produced from a  variety that increases the plant's resistance to certain pesticides.   Genetically-engineered corn with certain pest resistant characteristics is also rapidly displacing more traditional varieties. And, it gets even more interesting when you consider that researchers are looking at genetically-modified mosquitoes that cannot carry malaria.

"So, what do we think about this new carrot? Are we concerned about the environmental effects we still don't fully understand? What about the farm workers who are now unemployed? Should one company have a monopoly on it? =And finally, are you concerned about these issues and about how it is produced? Would you still have eaten it if you knew about the kudzu gene?  Should you have been told? Would you buy it?

"Folks, this is the tip of the biotechnology iceberg. There are many more questions that haven't yet been thought of, much less answered. But first of all, and if you come away with a dominant point from my remarks, it is that I want you to know that biotechnology has enormous potential.

"Biotechnology is already transforming medicine as we know it.  Pharmaceuticals such as human insulin for diabetes, interferon and other cancer medications, antibiotics and vaccines are all products of genetic engineering. Just yesterday I read that scientists at Virginia Polytechnic
Institute will process drugs from milk from genetically altered cows. One new drug has the potential to save hemophiliacs from bleeding to death.  Scientists are also looking at bananas that may one day deliver vaccines to children in developing countries.

"Agricultural biotechnology has enormous potential to help combat hunger. Genetically modified plants have the potential to resist killer weeds that are, literally, starving people in Africa and other parts of the developing world.

"Biotechnology can help us solve some of the most vexing environmental problems: It could reduce pesticide use, increase yields, improve nutritional content, and use less water. We're employing bioengineered fungi to remove ink from pulp in a more environmentally sensitive manner.

"But, as with any new technology, the road is not always smooth. Right now, in some parts of the world there is great consumer resistance and great cynicism toward biotechnology. In Europe protesters have torn up test plots of biotechnology-derived crops and some of the major food companies in Europe have stopped using GMOs genetically-modified organisms in their products.

"Yesterday's news was that the WTO affirmed our view that the EU is unjustifiably blocking US ranchers from selling beef produced with completely tested and safe growth hormones. Today we're seeing that the G-8 agreed to a new review of food safety issues and, having myself just come back from France a couple of weeks ago, I can assure you that trade in GMOs is looming larger over US-EU trade relations in all areas.

"Now, more than ever, with these technologies in their relative infancy, I think it's important that, as we encourage the development of these new food production systems, we cannot blindly embrace their benefits. We have to ensure public confidence in general, consumer confidence in particular, and assure farmers the knowledge that they will benefit.

"The important question is not, do we accept the changes the biotechnology revolution can bring, but are we willing to heed the lessons of the past in helping us to harness this burgeoning technology. The promise and potential are enormous, but so too are the questions many of which are completely legitimate. Today, on the threshold of this revolution, we have to grapple with and satisfy those questions so we can in fact fulfill biotechnology's awesome potential.

"To that end, today I am laying out 5 principles I believe should guide us in our approach to biotechnology in the 21st century. They are:

1. An Arm's Length Regulatory Process.
   Government regulators must continue to stay an arm's length, dispassionate distance from the companies developing and promoting these products; and continue to protect public health, safety and the environment.
2. Consumer Acceptance.
   Consumer acceptance is fundamentally based on an arm's length regulatory process. There may be a role for information labeling, but fundamental questions to acceptance will depend on sound regulation.
3. Fairness to Farmers.
   Biotechnology has to result in greater, not fewer options for farmers. The industry has to develop products that show real, meaningful results for farmers, particularly small and medium size family farmers.
4. Corporate Citizenship.
   In addition to their desire for profit, biotechnology companies must also understand and respect the role of the arm's length regulator, the farmer, and the consumer.
5. Free and Open Trade.
   We cannot let others hide behind unfounded, unwarranted scientific claims to block commerce in agriculture.

Arm's Length Regulatory Process

"When I was a school board member in Wichita, Kansas, one of my tasks was to study the level of student participation in the school lunch program. I quickly learned if the food didn't taste or look good, no matter how nutritious it was, the kids wouldn't eat it.

"With all that biotechnology has to offer, it is nothing if it's not accepted. This boils down to a matter of trust trust in the science behind the process, but particularly trust in the  regulatory process that ensures thorough review -- including complete and open public involvement. The process must stay at arm's length from any entity that has a vested interest in the outcome.

"By and large the American people have trust and confidence in the food safety efforts of USDA, the FDA, EPA, CDC and others because these agencies are competent and independent from the industries they regulate, and are viewed as such, That kind of independence and confidence will be required as we deal with biotechnology.

"The US regulatory path for testing and commercializing biotechnology products as they move from lab to field to marketplace is over a decade old. We base decisions on rigorous analysis and sound scientific principles. Three federal agencies USDA, FDA, and EPA each play a role in determining the use of biotechnology products in the United States: USDA evaluates products
for potential risk to other plants and animals. FDA reviews biotechnology's effect on food safety. And the EPA examines any products that can be classified as pesticides.

"Right now, there are about 50 genetically altered plant varieties approved by USDA. And so far, thanks to the hard work and dedication of our scientists, the system is keeping pace. But, as I said, the system is tried and tested, but not perfect and not inviolate and should be improved where and when possible.

"To meet the future demand of the thousands of products in the pipeline will require even greater resources, and a more unified approach and broader coordination.

"When I chaired the US delegation to the World Food Conference in Rome in 1996, I got pelted with genetically modified soybeans by naked protesters. I began to realize the level of opposition and distrust in parts of Europe to biotechnology for products currently on the market or in the pipeline.

"I believe that distrust is scientifically unfounded. It comes in part from the lack of faith in the EU to assure the safety of their food. They have no independent regulatory agencies like the FDA, USDA or EPA. They've had many food scares in recent years -- mad-cow disease, and in just the last several weeks, dioxin-tainted chicken -- that have contributed to a wariness of any food that is not produced in a traditional manner notwithstanding what the science says. Ironically they do not share that fear as it relates to genetically modified pharmaceuticals.

"But, GMO foods evoke in many circles a very volatile reaction. And that has created a serious problem for the U.S. and other countries as we try to sell our commodities in international markets.

"We need to make sure our regulatory system has the foresight to begin addressing issues even before they arise. So to keep pace with the accelerating growth of agricultural biotechnology, I am taking several additional steps to ensure we are fully prepared to meet the regulatory challenges of this new technology.

"Today I'm announcing that I will be asking for an independent scientific review of USDA's biotech approval process. The purpose of this review will be to ensure that, as we are faced with increasingly complex issues surrounding biotechnology, our scientists have the best information and tools to ensure our regulatory capabilities continue to evolve along with advances in the new technology. And to address complex issues like pharmaceutical producing plants or genetically modified livestock we will need to consult the experts, many of whom are outside USDA.

"Two of the more significant challenges we face are grower and consumer awareness, and improving monitoring on a long term basis. We do not have evidence the heavily publicized Monarch butterfly lab study appears to be happening in the field. But, the resulting attention to the reports and ensuing debate underscore the need to develop a comprehensive approach to
evaluating long-term and secondary effects of biotech products.

"So, USDA will propose the establishment of regional centers around the country to evaluate biotech products over a long period of time and to provide information on an ongoing basis to growers, consumers, researchers and regulators.

"To strengthen biotechnology guidelines to ensure we can stay on top of any unforeseen adverse effects after initial market approval, I am requesting all developers of biotech products to report any unexpected or potentially adverse effects to the Department of Agriculture immediately upon discovery.

"Finally, we need to ensure that our regulators just regulate and only regulate. A few years ago, we created a food safety agency separate and distinct from any and all marketing functions to ensure that no commercial interests have even the appearance of influence on our decisions regarding food safety. It needs to be the same with biotechnology. The scientists who evaluate and approve biotech products for the market must be free of any hint of influence from trade support and other non-regulatory areas within USDA.

"We at USDA will undertake a review to reinforce the clear line between our regulatory functions and those that promote and support trade. This reaffirms our basic principle that we will remain scrupulously rigid in maintaining an arm's length regulatory process.

Consumer Acceptance

"However strong our regulatory process is, it is of no use if consumer confidence is low and if consumers cannot identify a direct benefit to them. 

"I have felt for some time that when biotechnology products from agriculture hit the market with attributes that, let's say, reduce cholesterol, increase disease resistance, grow hair, lower pesticide and herbicide use, and are truly recognized as products that create more specific public benefits, consumer acceptance will rise dramatically.

"There's been a lot of discussion as to whether we should label GMO products. There are clearly trade and domestic implications to labeling to be considered in this regard. I know many of us in this room are sorting out these issues. At the end of the day many observers, including me, believe some type of informational labeling is likely to happen. But, I do believe that it is imperative that such labeling does not undermine trade and this promising new technology.

"The concept of labeling particular products for marketing purposes is not a radical one. For example, USDA has already decided that for a product to be certified as organic under our pending organic agriculture rules, a GMO product would not qualify. And that does not mean that USDA believes organic is safer or better than non-organic all approved foods are safe it just means that consumers are given this informed choice.

"There clearly needs to be a strong public education effort to show consumers the benefits of these products and why they are safe. Not only will this be the responsibility of private industry and government, but I think the media will play a vital role. It's important that the media treat this
subject responsibly and not sensationalize or fan consumer fears. That's what we're seeing happen in the EU and the outcome is fear, doubt and outright opposition.

"What we cannot do is take consumers for granted. I cannot stress that enough. A sort of if-you-grow-it-they-will-come mentality. I believe farmers and consumers will eventually come to see the economic, environmental, and health benefits of biotechnology products, particularly if the industry reaches out and becomes more consumer accessible.

"But, to build consumer confidence, it is just like it is with the way we regulate our airlines, our banks and the safety of our food supply consumers must have trust in the regulatory process. That trust is built on openness. Federal agencies have nothing to hide. We work on behalf of the
public interest. Understanding that will go a long way to solving the budding controversy over labeling and ensuring that consumers will have the ability to make informed choices.

Fairness to Farmers

"Like consumers, farmers need to have adequate choices made available to them. But today, American agriculture is at a crossroads. Farmers are currently facing extremely low commodity prices and are rightfully asking what will agriculture look like in the years to come and what will their roles be.

"That also means they have more responsibility and more pressure. And much of the pressure they face originates from sources beyond their control. We are seeing social and economic trends that have a powerful effect on how farmers do business. We are seeing increased market concentration, a rise in contracting, rapidly evolving technologies such as information power and
precision agriculture in addition to biotechnology. We are seeing different marketing techniques such as organics, direct marketing, coops and niche markets, and an expansion of non-agricultural industrial uses for plants.

"One of my biggest concerns is what biotechnology has in store for family farmers. Consolidation, industrialization and proprietary research can create pitfalls for farmers. It threatens to make them servants to bigger masters, rather than masters of their own domains. In biotechnology, we're
already seeing a heated argument over who owns what. Companies are suing companies over patent rights even as they merge. Farmers have been pitted against their neighbors in efforts to protect corporate intellectual property rights.

"We need to ensure that biotechnology becomes a tool that results in greater -- not fewer -- options for farmers. For example, we're already hearing concerns from some farmers that to get some of the more highly desirable non-GMO traits developed over the years, they might have to buy biotechnology seeds. For some, that's like buying the car of your dreams but only if you get it in yellow. On the other hand, stress-tolerant plants are in the pipeline which could expand agricultural possibilities on marginal lands which could be a powerful benefit to poor farmers.

"The ability of farmers to compete on a level playing field with adequate choices available to them and without undue influence or impediments to fair competition must be preserved. As this technology develops, we must achieve a balance between fairness to farmers and corporate returns.

"We need to examine all of our laws and policies to ensure that, in the rush to bring biotech products to market, small and medium family farmers are not simply plowed under. We will need to integrate issues like privatization of genetic resources, patent holders rights and public research to see if our approach is helping or harming the public good and family farmers.

"It is not the government who harnesses the power of the airwaves, but it is the government who regulates it. That same principle might come to apply to discoveries in nature as well. And that debate is just getting started.

Corporate Citizenship

"If the promises hold true, biotechnology will bring revolutionary benefits to society. But that very promise means that industry needs to be guided by a broader map and not just a compass pointing toward the bottom line.

"Product development to date has enabled those who oppose this technology to claim that all the talk about feeding the world is simply cover for corporate profit-making. To succeed in the long term, industry needs to act with greater sensitivity and foresight.

"In addition, private sector research should also include the public interest, with partnerships and cooperation with non-governmental organizations here and in the developing world ensuring that the fruits of this technology address the most compelling needs like hunger and food security.

"Biotechnology developers must keep farmers informed of the latest trends, not just in research but in the marketplace as well. Contracts with farmers need to be fair and not result in a system that reduces farmers to mere serfs on the land or create an atmosphere of mistrust among farmers or between farmers and companies.

"Companies need to continue to monitor products, after they've gone to market, for potential danger to the environment and maintain open and comprehensive disclosure of their findings.

"We don't know what biotechnology has in store for us in the future, good and bad, but if we stay on top of developments, we're going to make sure that biotechnology serves society, not the other way around.

"These basic principles of good corporate citizenship really just amount to good long-term business practices. As in every other sector of the economy, we expect responsible corporate citizenship and a fair return. For the American people, that is the bottom line.

Free and Open Trade

"The issues I have raised have profound consequences in world trade.  Right now, we are fighting the battles on ensuring access to our products on many fronts. We are not alone in these battles Canada, Australia, Mexico, many Latin American, African and Asian nations, agree with us that sound science ought to establish whether biotech products are safe and can move in international commerce.

"These are not academic problems. For 1998 crops 44% of our soybeans and 36% of our corn are produced from genetically modified seeds. While only a few varieties of GMO products have been approved for sale and use in Europe, many more have been put on hold by a de facto European moratorium on new GMO products.

"Two weeks ago I went to France and met with the French Agriculture Minister at the request of the US ambassador there, Felix Rohatyn, to see if we can break this logjam which directly threatens US-EU relations at a delicate time when we are commencing the next WTO round in Seattle.

"Quite frankly the food safety and regulatory regimes in Europe are so split and divided among the different countries that I am extremely concerned that failure to work out these biotech issues in a sensible way could do deep damage to our next trade round and effect both agricultural and non-
agricultural issues. For that reason, the French Minister's agreement to have a short-term working group with USDA on biotech approval issues, and his willingness to come to the US in the fall to further discuss the situation, is encouraging.

"To forestall a major US-EU trade conflict, both sides of the Atlantic must tone down the rhetoric, roll up our sleeves and work toward conflict resolution based on open trade, sound science and consumer involvement. I think this can be done if the will is there.

"However, I should warn our friends across the Atlantic that, if these issues cannot be resolved in this manner, we will vigorously fight for our legitimate rights.

Conclusion

"Finally, I've established a Secretary's Advisory Committee on Agricultural Biotechnology -- a cross-section of 25 individuals from government, academia, production agriculture, agribusiness, ethicists, environmental and consumer groups. The committee, which will hold its first meeting in the fall, will provide me with advice on a broad range of issues relating to agricultural biotechnology and on maintaining a flexible policy that evolves as biotechnology evolves.

"Public policy must lead in this area and not merely react. Industry and government cannot engage in hedging or double talking as problems develop, which no doubt they will.

"At the same time, science will march forward, and especially in agriculture, that science can help to create a world where no one needs to go hungry, where developing nations can become more food self-sufficient and thereby become freer and more democratic, where the environmental challenges and clean water, clean air, global warming and climate change, must be met with sound and modern science and that will involve biotechnological solutions.

"Notwithstanding my concerns raised here today, I would caution those who would be too cautious in pursuing the future. As President Kennedy said, "We should not let our fears hold us back from pursuing our hopes."

"So let us continue to move forward thoughtfully with biotechnology in agriculture but with a measured sense of what it is and what it can be. We will then avoid relegating this promising new technology to the pile of what-might-have-beens, and instead realize its potential as one of the tools that will help us feed the growing world population in a sustainable manner.

"Thank you."

USDA news release
N1960