Following is the text of Siddiqui's remarks as prepared for delivery:

Remarks by
Special Trade Adviser to the Secretary of Agriculture
Dr. Isi Siddiqui

Conference on "Biotechnology: The Science And The Impact"
January 20, 2000
The Hague, Netherlands

Thank you very much for that kind introduction, and for the opportunity that you have given me to offer my thoughts on this defining issue for the new century.

It's my hope that this conference and others like it are the beginning of a more intellectual and productive dialogue on genetic engineering, one where we move toward consensus rather than further isolating ourselves in rigid ideological camps.

Let me begin by saying that (Agriculture) Secretary (Dan) Glickman and I are believers in the life sciences and their ability to alleviate human suffering and enhance the productivity and sustainability of agriculture around the world. But we also believe that technological progress must never come at the expense of environmental degradation or human safety ... that government has a responsibility to protect the people where they are largely powerless to protect themselves.

People always want us to choose sides in this debate, but I don't think it is government's job either to actively promote or thwart biotechnology. Rather, our role is as impartial judge. We evaluate prospective biotechnology products, ensuring that they meet our rigorous human safety and environmental standards.

To do this, we have a regulatory process that is tight, comprehensive and grounded in the most demanding, scrupulous science. There are many strict checkpoints through which a GM product must pass on the road from petri dish to grocery store shelf.

Those checkpoints are manned by three different federal agencies working in sync with one another. At the Department of Agriculture, we guard against potential risks to plants and animals. The Food and Drug Administration is the watchdog for a GM product's impact on food safety. And the Environmental Protection Agency examines products that can be classified as pesticides. Regulators at all three agencies are scientists who work full-time on review of new products. They are not beholden to any political party or movement, nor to any entity that stands to profit from biotech commercialization.

In addition to being scientifically rigorous, the process is open and inclusive. We hold public meetings with scientific advisory panels. For each product, information is regularly posted on the Internet. Americans can believe in the integrity of the process because they have the opportunity watch it happen and participate in it themselves.

This system has worked. In 13 years, not a single product that has made it to market has been proven environmentally hazardous or unsafe for human consumption. Thirteen different GMO applications have been withdrawn voluntarily because of possible risks that our regulators would have caught. For example, a soybean variety that had been infused with a Brazilian nut gene was withdrawn because of the possibility that those allergic to the nut would have a similar reaction to the soybean.

In the next few minutes, I would like to focus specifically on the Agriculture Department's role in the approval process for transgenic crops.

The Department's Animal and Plant Health Inspection Service -- or APHIS, as we call it -- is the federal government's lead agency in regulating the safe development and release of biotechnology-derived, new plant varieties into the environment. Since 1987, we have overseen field testing at more than 22,000 sites and granted determinations of non-regulated status for 50 new crop varieties, thus allowing them to come to market. These products have already become a huge presence in the commercial marketplace. In 1998, 43 percent of the total U.S. cotton crop, 44 percent of the soybean crop, and 36 percent of the corn crop were genetically engineered. This year's figures will likely surpass those benchmarks.

Our authorities, under the Federal Plant Pest Act and the Plant Quarantine Act, require scientific researchers to obtain authorization prior to introducing genetically engineered organisms that are, or could possibly be, derived from plant pests.

Thus, when any entity -- a company, an academic research institution, a non-profit organization, or a government scientist -- wishes to field test a biotechnology-derived plant, they must first contact USDA for permission.

The field testing can proceed in one of two ways. The first involves obtaining a permit from us before testing, to ensure that the test is conducted in accordance with all regulatory requirements. USDA issues field testing permits annually, and each permit requires specific information from the tester about the plant, including all new genes and gene products, their origin, the purpose of the test, how the test will be conducted, and specific precautions that will be taken to prevent the escape of pollen, plants, or plant parts from the field test site.

Before authorizing a field test, we review the permit application for possible effects on the environment, endangered or threatened species, non-target species, and the potential for any gene transfer to cultivated wild or weedy species.

We also have a streamlined permit process, which most applicants can now use. The applicant provides a notification of the intent to field test, which USDA has 30 days to review and approve. Although these simplifications have shortened the overall permitting process, these field tests are still required to meet all the same safety standards as required under the original procedure. And no matter which permit process you pursue, even when the permit is approved, USDA officials and their state counterparts may inspect the field test site before, during, or after a test to ensure that it is conducted and managed safely. After several years of laboratory and field testing, a developer may decide to commercialize the genetically engineered variety and petition USDA to be released from regulatory oversight. In other words, the developer will submit a petition for "determination of non-regulated status."

Upon receipt of a petition, USDA thoroughly evaluates the scientific information provided. Specifically, we examine the biology and genetics of the plant; the nature and origin of the genetic material used; possible effects on other agricultural products and organisms in the environment; and all field test reports. Depending upon the particular plant line, we evaluates a variety of potential effects such as:

1. the potential for creating plant pest risk;

2. disease and pest susceptibilities;

3. the expression of gene products, new enzymes, or changes to plant metabolism;

4. weediness, and impact on sexually compatible plants;

5. agricultural or cultivation practices;

6. effects on non-target organisms, including humans;

7. effects on other agricultural products; and

8. the potential for gene transfer to other types of organisms.

USDA also completes an environmental assessment of the new variety to ensure the plant poses no significant risk to the environment, other plants or non-target species, including humans. Our agency evaluates all available scientific information, including the information provided by the developer in the petition. We then work to ensure that the new transgenic plant:

1. exhibits no plant pathogenic properties;

2. is no more likely to become a weed than the non-engineered plant;

3. is not likely to increase the weediness of any other plant with which it is sexually compatible;

4. will not cause damage to processed agricultural commodities; and

5. is not likely to harm other organisms that are beneficial to agriculture.

If it is determined that the new plant poses no significant risk to other plants in the environment and is as safe to use as more traditional varieties, USDA finalizes the environmental assessment and writes a determination of non-regulated status. This determination enables the new plant to be cultivated, tested, or used for traditional crop breeding without any additional action on our part. In essence, this determination allows the plant to be widely grown and commercialized.

As you can see, our biotech approval process is thorough, demanding and transparent. As confident as we are in it, we are working diligently to make it better, more airtight, more accessible and more responsive to the accelerating pace of technology.

At USDA, we asked the National Academy of Sciences to conduct an outside review of the approval process, and they came back with 89 suggestions. And soon we will announce the men and women who will serve on a committee that will advise Secretary Glickman on biotechnology issues. To ensure that the Secretary receives balanced advice, the committee will bring together a broad cross-section of opinions and expertise. Farmers and private sector representatives will sit on the panel, but so too will consumer advocates and representatives from environmental groups.

It is this kind of oversight, this kind of system of checks and balances, that is lacking in the EU. And that, I believe, is the source of consumer skepticism about GMOs among Europeans. Given the mad cow scare and the discovery of dioxin-tainted chicken, the skepticism is less a reaction to or a judgment about biotechnology itself ... than a lack of faith in their government to protect them from unsafe foods.

There have been some encouraging signs. During his visit to the United States in October, European Commission President Prodi signaled his commitment to establishing an independent European regulatory authority modeled on the United States' FDA. And Just last week, the Commission issued a white paper that calls for the establishment of an independent, transparent, science-based food safety regime.

President Prodi also has said that he understands that risk can never be eliminated altogether, that we have to make decisions about new technologies based on the science that is currently available. This would appear to be at least a slight retreat on the "precautionary principle," which has been the basis of European GMO policy. President Prodi is setting the right tone, and I believe a dialogue has at least begun that will help us resolve these issues.

But any such resolution will be a long time coming. And in the meantime, we're still in the middle of a divisive conflict on biotechnology, one that's creating serious transatlantic tension and a polarization that is counterproductive at best and destructive at worst.

All of us have a role to play in toning down the debate and building common ground. While the anti-GMO forces have been responsible for most of the outrageous rhetoric, even the biotech industry is not without blame.

In focusing their research and development on technologies that would help farmers -- those who grow the food -- industry overlooked the concerns of those who have to eat the food - consumers. Few current GMO products have the better taste, freshness and nutrition that consumers would expect from enhanced food. New genetically engineered rice fortified with Vitamin A and iron, developed by the Swiss Research Institute in Zurich, is a perfect example of the next generation of bioengineered crops from which consumers can accrue direct benefits.

The good news is that industry has begun to recognize some of its mistakes and adjust its strategy. At the same time that they have improved their marketing efforts and better explaining the benefits of biotechnology, they are also extending something of an olive branch to consumer groups and environmentalists, in an attempt to launch a more reasoned dialogue.

Further belligerence benefits nobody, certainly not farmers, many of whom rightly feel they've been sold a bill of goods on biotechnology. Already battered by low prices, they are now caught in the middle of what is literally and figuratively a food fight. They embraced GMOs at the behest of the seed companies. But when it turned out that the companies had miscalculated the market for GMOs, farmers were asked by those very same companies to perform the logistical and financial impossibility of segregating their GMO seeds from traditional varieties.

The United States stands by its biotechnology approval process. It is not simply a routine rubber-stamp. It is an exacting system that never begins with the assumption that the product is safe. The burden of proof is always on the product and its purveyors to prove safety, not on the consumer or on government to prove hazards. And we believe that, to increase the flow of agricultural trade, the EU and other nations need to adopt a similar system.

But we also remain open-minded. We hear the doubts and concerns about biotechnology expressed by people on both sides of the Atlantic and around the world, and we respect their concerns. Let's work together, so that we can allow for scientific progress without in any way compromising human or environmental safety. Thank you very much.

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