8 February 2000

Transcript: U.S. Officials Brief on Biosafety Protocol

U.S. officials report that the Biosafety Protocol recently negotiated in Montreal is a good agreement that protects the environment without disrupting world food supplies.

David Sandalow, assistant secretary of state for oceans and international environmental and scientific affairs, said in a digital video briefing with reporters in Brussels February 8 that the protocol has several positive features. He said one of the good things about the protocol is that it is the first global agreement that recognizes the benefits of modern biotechnology in the provisions of its preamble.

Sandalow said the protocol also calls for the establishment of a biosafety clearinghouse that "promises to be an extremely important tool for sharing information about modern biotechnology around the world." The protocol also contains unambiguous language making it clear that nothing in the agreement affects or changes a party's rights and obligations under the World Trade Organization.

Sandalow said that biotechnology offers many benefits, such as reducing pesticide usage, enhancing the nutritional content of foods, and helping to prevent rainforest destruction by enhancing agriculture productivity.

"We believe in many important benefits of this technology," he said. "We also believe, like any new technology, it has risks that must be managed."

Catherine Woteki, under secretary for food safety at the U.S. Department of Agriculture, reported that the United States has a tough regulatory system that has done an effective job in managing the risks.

"Here in the United States we have a hundred-year tradition of very strong laws on food safety," she said. "They...provide very substantial consumer protection and also have the concept of precaution as an integral part of the laws and the regulations governing food safety."

Following is the transcript of the press briefing:

(begin transcript)

U.S. Mission to the European Union Digital Video Press Briefing By David B. Sandalow, assistant secretary of state for Oceans and International Environmental and Scientific Affairs (OES), Department of State, and Catherine Woteki, under secretary for food safety, Department of Agriculture, with journalists at the U.S. Mission to the EU, Brussels, Belgium

February 8, 2000

WOTEKI : Good afternoon to all of you. I very much appreciate the opportunity to talk with you a little bit about food safety. I have very much noted the interest on both sides of the Atlantic in food safety, clearly our publics are very much concerned about food safety and about the food supply and it is an issue that has gained an enormous amount of attention as well within government.

I think that it is also very important though to recognize that there are some substantial differences in the level of public concern about food safety. Here in the United States we have a hundred year tradition of very strong laws on food safety. Our laws governing food safety were passed in 1906. They have been amended since then but they provide very substantial consumer protection and also have the concept of precaution as an integral part of the laws and the regulations governing food safety. We recognize as well that the Commission in Europe has recently issued a paper on Precaution, advising its Member States on how to apply a precautionary approach in the area of food safety as well as in environmental decisions.

I think it is important to draw a distinction though between a sovereign country, like the United States, with strong legal protections and a long history of food safety decisions that are based on precaution, and the current situation in which the Commission in Europe has issued this new guidance on Precaution to its Member States, which have a different tradition, in each and every country, in their legal structure and history of enforcement. Our regulatory agencies here in the United States are currently reviewing this communication.

We are very much looking forward to developing a better understanding of how the communications might facilitate attaining the aim of the Commission to avoid unwanted recourse to the precautionary principle as a disguised form of protectionism. We are very much looking forward to the dialogue that will be ongoing within Europe, and we hope that we will be able to gain some insight as to how the idea and the principles of precaution will move forward within the context of each of the member countries' laws and regulations, as well as the approach that the Commission will be taking. I am looking forward to answering any questions that you might have and I might at this point introduce my colleague, Assistant Secretary Sandalow.

SANDALOW: Thank you, Dr. WOTEKI. I am David Sandalow. I was up in Montreal helping to negotiate the Biosafety Protocol and I am happy to say just a few words about that agreement. This is a good agreement. On balance, it protects the environment without disrupting world food supplies. The success in Montreal could not have been achieved without the cooperative attitude and work from countries on both sides of the Atlantic and indeed around the world. The United States strongly appreciates the constructive attitude that many of our friends in Europe brought to these negotiations and we look forward to continuing to work on these issues in the years ahead. We have identified five features of the Biosafety Protocol that we think are especially positive.

First, the agreement focuses on the environment. It is important to emphasize that this is an environmental agreement. It is not a food safety agreement. There are other fora in which food safety is addressed. This agreement focuses mostly on the protection on biodiversity, which is its goal.

Second, this is the first global agreement we are aware of that recognizes the benefits of modern biotechnology. This agreement specifically recognizes those benefits in its preambulary provisions -- the first global agreement we know of that does so.

Thirdly, the establishment of the 'biosafety clearinghouse' -- which promises to be an extremely important tool for sharing information about modern biotechnology around the world. Under the provisions of this agreement, governments will provide important information about the issues and approvals concerning modern biotechnology to the clearinghouse. The clearinghouse will run a world wide web site which will make available important information on environmental risks and benefits associated with modern biotechnology. It is also particularly helpful that this clearinghouse will be a place for gathering information about regulatory programs from governments around the world with respect to modern biotechnology, and that may become a very important resource as well.

Fourth, this agreement has good provisions on capacity-building for developing countries, and will help developing countries manage biotechnology in the decades ahead.

And finally, this agreement contains an unambiguous WTO savings clause, making clear that nothing in the Biosafety Protocol affects or changes rights and obligations under the WTO.

All and all, just to repeat, I think this is a good agreement. Our hope is that, in the medium term at least, it will help to de-polarize the debate on biotechnology and allow this technology to realize its potential benefits around the world while appropriately managing the risks as well. Thank you.

QUESTION: It is on the Bio-safety Protocol. Obviously trans-Atlantic relations are colored by the GMO question, trade in genetically modified organisms: will the Biosafety Protocol in any way change the relationship, dissolve the problems, how will it contribute to the trans-Atlantic relationship?

SANDALOW: We certainly hope that it will contribute to a positive, constructive dialogue on this topic. In the United States, we strongly believe that modern biotechnology has very important potential benefits. Those potential benefits include protecting the environment. For example, in parts of the United States, we are already seeing less pesticides usage as a result of planting BT corn. Modern technology also offers the potential to help protect rainforests. In many places around the world rainforests are under pressure because of the need to expand farmlands to feed growing populations. Modern biotechnology can enhance agriculture productivity and thereby help to protect rainforests.

In addition, biotechnology offers important potential for helping to feed poor children around the world. Just in the last couple of weeks, there has been important data on the opportunities for enhancing the vitamin A content of rice using modern technology. I understand that that is just the beginning -- that there are opportunities for enhancing micro-nutrient content and other nutritional content in food by using this technology. So, we believe in many important benefits of this technology. We also believe, like any new technology, it has risks that must be managed. And in our country, as Dr. Wotecki was saying, we have a regulatory system that has done that effectively. And this is a perspective that we bring to all of our discussions with our European friends, and we hope that this Biosafety Protocol will be a useful tool for depolarizing the debate by helping to make the dialogue more constructive on this issue.

WOTEKI : I think I would also like to add a little bit. The recent announcement of the rice variety that has been enhanced with beta-carotene really underscores the health benefits that can accrue from this technology. You may know that vitamin A-deficiency is the leading cause of blindness around the world. Also, children who are vitamin A-deficient -- but only marginally deficient -- are much more susceptible to infectious diseases, and have a much higher morbidity rate or illness rate from infectious diseases, and a much higher mortality from these childhood infectious diseases as well. So, being able to provide vitamin A as beta-carotene in foodstuffs without having to do food fortification, or without having to give children an injection or a pill, would be an enormous step forward in preventing these very preventable diseases. So, I think that this is a contribution of biotechnology. It has a great health-promoting effect that really needs to be noted .

Q: Commissioner Wallstr��, when she came back from Montreal, said that nothing in the Biosafety Protocol will change EU rules and the attitude towards GMO authorizations. Is that your understanding as well?

SANDALOW: I don't have any specific understanding about EU regulations, and would not want to comment on that. I will say that I appreciate the role that Commissioner Wallstr�� played in the negotiations, and look forward to working with her on this issue in the years ahead.

Q: Still on the Biosafety Protocol. Could I just ask, what part of the agreement you think actually bear the mark of the U.S. or the Miami Group? It seems as though, on the face of it, it's pretty much the shape of what the EU is negotiating. It's got an AIA (Advance Informed Agreement) for LMOs (Living Modified Organisms) for the environment, countries can still refuse LMOs for feed and food use, they got the word "human health safety" in there as well as environment. There are labeling requirements. And of course there is the notorious "precautionary principle". Which parts of the agreement specifically are what the Miami Group was after?

SANDALOW: Well, the agreement as a whole reflects the discussions and negotiations among all countries during the week that we were in Montreal, and I would not identify any individual part as being a product of any individual country. I will clarify just a few of the issues that you noted on human health. It is important to note that the human health provisions in the Biosafety Protocol are specifically tied to impacts upon biodiversity. What the Biosafety Protocol makes clear is that, if the transboundary movement of a bioengineered product has an effect on biodiversity, for example, by causing a species to become extinct and that extinction has an impact on human health -- then that human health impact can be considered under the Protocol. But the Protocol does not provide for consideration of human health directly as a result of a transboundary movement of a bio-engineered product, absent an impact on biodiversity. That is because this is an environmental agreement. An agreement that is focused on the protection of biodiversity is not an agreement focused on human health.

Q: About the precautionary principle, you mentioned that your national regulatory authorities are considering what it all means, but I mean presumably you must have some kind of initial reaction to what the Commission's document contains. Could you tell me what that is?

WOTEKI : Essentially what we are doing at this point is reading through the document. We understand it as largely being advice from the Commission to its member-states. As I indicated, within the United States, we have very strong laws that govern food safety, that have written into them requirements for what we consider to be a precautionary approach. We will be looking forward certainly to the visit later this week that Commissioner Byrne will be making to the United States to get an understanding of how he views this discussion within the Community about the precautionary principle and its application. But within the United States, our laws and regulations are built on a precautionary approach.

Q: I just want to take up something I think that the EU likes to stress about the precautionary principle, which is this famous -- when they are not able to quantify or really able to nail down the risk that a product may present, the precautionary principle comes into effect. Now, the U.S., it seems to me, as you and your colleagues have said, has this established food regulatory, food safety mechanism, by which obviously they don't think something like the precautionary principle has any place. How can you explain the disparity between the two, and do you think, as a result, that the precautionary principle is something that should not really be used if there is a centralized food safety agency in Europe?

WOTEKI : I think that -- actually, your question has two parts to it, and the first is, here, within the United States, the approach that we take is based on the identification of a hazard. That a substance that is intended to be added to food, or a substance that is an adventitious appearance in food like an environmental contaminant, that first of all, that there be an indication that it poses a hazard -- that it will do something harmful -- and secondly, we use risk assessment to determine what the nature of the risk is to the population. So, all of those are requirements that are laid out in our statutes and in our regulations.

One of the things that we have found very difficult to understand in our discussion about the precautionary principle, is -- if there is no hazard that has been identified, but some concern voiced -- it is very difficult for us to understand why you would apply a precautionary principle. Clearly, we want to use a science-based approach, which is what our system is premised on, and along with that, the very strong regulatory follow-up that we have with inspection and enforcement.

The second part of your question has to do within Europe, particularly within the Commission. That's clearly a decision that is being discussed for example in the second paper that was released just a few weeks ago about the establishment of food safety authority in Europe that would do the risk assessment, and also the research underlying it to identify hazards in the food supply. So we think that is a very positive step. But those discussions clearly have to go on within the Community.

Q: What about the fact that they fairly clearly say that the risk management side of an eventual food hazard or food safety problem remains within the politicians or within the national government of the countries concerned. Does the U.S. see that as perpetuating the problem that they see the precautionary principle as posing?

WOTEKI : I guess I can respond to it from an historical perspective. The reason that our food safety laws at the national level were put in place in 1906 was largely because of disputes between States about things like food quality requirements, labeling, as well as food safety concerns. So the reason for the passage of those two laws in 1906 that are the Food Drug and Cosmetic Act and the Federal Meat Inspection Act was largely to respond to these issues of interstate commerce and consumer protection between States. So, drawing a parallel with what's going on now in Europe, clearly, there are member-states that have different traditions, different laws, and different regulations. Those have been increasingly harmonized. They are supposed to protect health as well as to facilitate commerce and trade among those states, and clearly the Commission's goal is furthering that harmonization. So this safety authority that's being established, at least on the risk assessment side, is a step forward. It's a decision that the Community members have to make, as to the extent to which they would want to see that enforcement authority as well as the other aspects of risk management. But I think the discussion is ongoing.

Q: Commissioner Byrne at a press conference after unveiling the precautionary principle said that the EU would use the precautionary principle to argue its case in the WTO on its ban on meat with hormones. I was wondering if anybody is qualified there to respond as to how the U.S. responds to that. Is it acceptable that the precautionary principle can be applied in WTO cases, and, if so, how would the U.S. argue against that?

WOTEKI : I certainly did not hear the Commissioner's comments so I do not feel that I can really comment on his comments.

Q: My question is linked to that. The Communication talks about what happens in the presence of a minority scientific opinion. Where there is a majority scientific opinion, it is clear that there is a risk or not. But there is a big question still about what happens when you have a minority scientific opinion that says the opposite from the generally held view. The feeling here is when there is a minority opinion, the precautionary principle kicks in. On the beef hormone (issue), Europe says that it has evidence that beef hormones are dangerous to health, and in the U.S. you say the opposite. So, is this in any way going to help this current situation, specifically on beef hormones, or on other issues in general?

WOTEKI : I can speak from my own experience as a scientist. I have spend most of my career in public health research and virtually every single decision that risk manager has to make in a regulatory agency, you have to make your decisions based on the preponderance of the scientific evidence. In virtually every decision that I have been involved in, since I have been in a regulatory position, there is some evidence usually to the contrary. But the decision makers -- they have to make decisions based on the preponderance of scientific evidence. And I think one of the key things that will continue in the discussion in the precautionary approach that we use in the U.S. and the elucidation of the precautionary principle is the identification of whether there is a hazard -- again based on the preponderance of the scientific information. And then if that poses a risk to the population. In the case of beef hormones, our Food and Drug Administer based the decision on the preponderance of the scientific information that these six hormones -- three of them are naturally occurring, three of them are synthetic -- do not pose an undue risk to the population under the circumstances of use in which they are applied here in the United States. So, it is an acceptable level of risk to our population. And there are benefits that accrue from the use of these substances as well. We have an ample supply of high quality meat products. These hormones are applied primarily in beef cattle. That has been the subject of the dispute between the EU and the United States. But clearly this has been a good example of a case where the preponderance of scientific information as to the hazard that is caused, and the level of risks to the population, is extremely low. And therefore, under the circumstances of use in the United States, it does not pose any safety issue to our consuming population.

Q: Is there anybody there qualified to give us an opinion on whether you think that tomorrow the European Union will continue with the green light for non-hormone treated beef exports to the EU?

WOTEKI : We have been in correspondence with authorities there. We feel that it is a good program and we are looking forward to the decision of the Veterinary Committee.

(end transcript)

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