WEDNESDAY 8 JULY 1998

MR TIMOTHY GALVIN

  375.  Mr Galvin, good morning and welcome to the Sub-Committee. I start by thanking you very much for having taken the trouble to come all the way from the United States to give evidence and help us in our enquiry into genetic modification in agriculture with particular reference to regulation. We have just received from you written answers to some of the questions that we put to your department relating to the practices in the United States. Having had a quick glance at the document, it appears to be a very full reply to our questions. I believe that initially you had difficulty in answering these questions due to the fact that other departments of state needed to be consulted. If that is the case these answers have been provided with great speed. We are extremely grateful that you have been able to do this. Perhaps you would thank on our behalf all those involved. I understand that you propose to begin by making a brief introductory statement. If that is the case, I give you the floor straight away.
  (Mr Galvin)  My Lord Chairman and members of the Sub-Committee, I appreciate this opportunity to present the views of the US Department of Agriculture with respect to the regulation of genetic modification in agriculture. As a former staff member of the US Congress for nearly 17 years, I consider it a special privilege to be here this morning. In advance of today's hearing the Sub-Committee posed a number of questions to the US Department of Agriculture. Those questions sought more information about the details of the US system for regulating genetically modified organisms as well as our views on the European Union's regulation of those products. Because the US regulatory system involves three separate federal agencies—the Animal and Plant Health Inspection Service, the Environmental Protection Agency and the Food and Drug Administration - we consulted with those agencies in answering the questions relating to the specifics of the US regulatory regime. As has been indicated, I am providing those answers to the Sub-Committee this morning. In addition, the Sub-Committee asked us to review and comment upon a draft paper that has been prepared for the Sub-Committee that analyses the US regulatory system. This is a matter that also requires input from our three regulatory agencies. They have asked for additional time to prepare a response. With your permission, our reaction to that paper will be provided next week. The Sub-Committee's effort to examine the regulation of agricultural biotechnology is one that we welcome and are eager to support. We fully recognise that the EU has the right to put in place its own system for governing the approval and marketing of genetically modified products. Our chief concern is that such a system be characterised by certainty, timeliness and an adherence to those science-based standards that are necessary to ensure the protection of consumers and the environment. Similarly, we are concerned that any policy developed for the labelling of these products be practical and not constitute a barrier to trade. For our part, we in the US Government have been engaged with EU officials on a bilateral basis to share information and foster co-operation in this area. We have also been active participants in the Trans-Atlantic Business Dialogue (TABD) and are encouraged by progress made under the TABD to improve the regulatory systems on both sides by exploring common regulatory approaches, such as requiring similar data submissions. In our view, there is much at stake in achieving an improved means to regulate biotechnology worldwide. Clearly, the acreage devoted to genetically modified varieties is increasing rapidly, as is the number of varieties being offered to the marketplace, with obvious implications for trade and commerce in general. More importantly, these products if regulated properly offer significant benefits in the form of reduced chemical use, improved yields, lower production costs and enhanced qualities for consumers and other end users. I appreciate the opportunity to be here and look forward to answering your questions.

  376.  Can you explain to the Sub-Committee what you see as the fundamental difference between the EC approach to biotechnology regulation and that undertaken in the US?

  A.  In general, the key difference is that in the US our regulatory system is well established. From the standpoint of the regulated community it is viewed as offering a reasonable degree of certainty with respect to requirements and procedures. By contrast, the EU regulatory system is perceived as still evolving. Therefore, it is viewed as uncertain and subject to changing procedures that perhaps are not always driven by science-based requirements to ensure safety of the regulated products. Currently, the issue of uncertainty as it relates to product labelling and approval probably gives rise to the greatest difference.

  377.  Do you think that in Europe we look more at wider environmental issues than in the United States?

  A.  I do not believe so. Frankly, I believe that there is great interest in both the US and EU in looking at the environmental side of the equation and trying to provide reassurance that these products are safe. I do not perceive that there is a greater concern or awareness in the EU than in the US. We are fortunate in the sense that in the US we went through this whole procedure a decade ago. The procedures are well accepted and well known by the regulated community as well as by consumers groups that closely follow the process.

  378.  Is the situation in the US fairly stable? There is no pressure to change the regulatory system in any way to take into account considerations that hitherto have not been taken into account?

  A.  More recently, there was a request by some consumer groups for the labelling of these products. There are some in the US who believe that we should do more to regulate these products or label them, but they tend to represent a minority. The overwhelming majority of the public accepts the procedures that we have in place. Part of the reason for that is that from the very start our process involved a period of public comment and review. Even to this day as specific products are reviewed and approved they are noted in our federal register so that there is an awareness on the part of those following this issue as to exactly what steps the federal agencies have taken to approve these products.

  379.  You referred to labelling. In supermarkets in the United Kingdom every genetically modified product is labelled. Are you saying that in the US some products are not labelled as such?

  A.  That is correct.

  380.  Consumers are not aware that they are eating genetically modified products?

  A.  Not in each and every case, but they are aware that these products have been approved and are available in the marketplace.

  381.  You are critical in your paper of the EC approval system. What changes would the US like to see take place?

  A.  The issue comes down to certainty, timeliness and transparency in the process. We view the EU system as still evolving. Frankly, we are confused as to which authority is controlling this area. Is it Directive 90/220 EEC or the Novel Food Regulations, and so on? We do not know exactly what procedures the various companies must follow in getting products approved. That uncertainty is now complicated by the new proposal on labelling because the practical aspects of that policy are not clear to us. For example, it is not clear what testing will be required or whether these commodities have to be identity preserved all the way through the process to the final consumer.

  382.  In the US, who assesses a product before it is allowed into the marketplace? What issues are examined? Are scientific committees consulted?

  A.  It is science-based. The Department of Agriculture examines these products to determine their likely impact on other plants or animal species. We review products for safety to agriculture. The Environmental Protection Agency looks at the impact of these products on the environment generally, especially since the EPA also regulates pesticide use. Many of these products are in some way related either to pesticide use or have inherent qualities that allow them to combat certain pests. The Food and Drug Administration, however, reviews these products to make sure that in the end they are safe to any consumers who may eat them.

  383.  Clearly, in the United States the public has tremendous confidence in the system that the US Government operates in terms of food. At the same time, it has turned out to be very effective in that the public has been given warnings about certain foods which have been quickly withdrawn from the market. In Europe the experience is very different. There is considerable concern about it. Very often, what governments say is the opposite of what people believe. How would you tackle that on a European basis? Would you like to see a more European-based committee or group that considered all of these issues? You talk about certainty, but how do you take the first steps in ensuring that there is certainty and that consumers can have confidence that what the body says is correct?

  A.  That takes us back to the first steps that the US took when it put its policy in place. We went to the public and offered a proposal for the regulation of these products. That proposal was subject to public comment and review. That transparency in the system has been ongoing ever since, in the sense that we have scientific committees that meet periodically to review issues that come up. We also issue public notices on products that are approved. I believe that in the view of those members of the public who follow this issue there is a sense that we have not hidden anything and everything is on the table for consideration. With all due respect, I suggest that that is an important way of moving ahead and building public confidence in this area. I have seen some of the polling data both in the US and Europe with regard to consumer attitudes towards biotechnology. From what I have seen, it appears that the difference between the attitudes in the US and those in many European countries are not that great. In general, it appears that about two-thirds of the public endorse the idea of biotechnology, at least from the survey data that I have seen. I am happy to share that with the Sub-Committee this morning. For example, if you ask consumers even in Europe how they rank the various threats to public health at the very top is bacteriological contamination and biotechnology ranks at about no.8, just ahead of food colouring.

  384.  In the paper that we received from you a criticism was made of the Commission's use of review by scientific committees, particularly in the case of corn. Do you recall that and, if so, would you care to comment on it?

  A.  It does ring a bell. We are not at all opposed to scientific review in the case of these products. What we were concerned about in this specific instance was the fact that this particular scientific review was introduced very late in the process after the same products had already been reviewed at the Member State level and then by the Commission itself. Therefore, our concern was that it represented a change in procedure very late in the game that added another scientific review to the process.

  385.  You are also critical of the EC regulatory system on the ground of politicisation. Can you explain what you mean by that?

  A.  Perhaps the best recent example of that is the situation that we face in France where two of our corn products still await final approval. These products were reviewed by France more than two years ago and then sent to the Commission. The Commission approved those products in April after that extensive review and re-review. They were then sent back to France for final technical approval which should have been almost a formality. Although these products have received clearance by the Commission, France withheld that final step of approval, even though French officials assured us that there were no concerns about science or consumer safety; rather, there was concern about public opinion. Therefore, France said that it would be holding a so-called consensus conference. That took place about three weeks ago. I believe that that will be the final step before they decide whether or not to let these products go.

  386.  Is the problem in Europe that there are consumer concerns which are different in various Member States which make themselves felt through government action at different stages in the process? This is not a problem that you have in the United States, though I understand from what you say that perhaps you had such a problem at one time. How can governments avoid taking account of such public opinion?

  A.  I recognise and appreciate the difficulty in Europe of trying to get the approval of 15 different Member States. Frankly, that is not a situation we face in the US. We do not have to go to any of our 50 states to get approval for these products. In that respect we are very fortunate. In terms of increasing public confidence in whatever approval system is put in place, we would encourage those concerned to take additional steps to increase the transparency of the process or invite consumer and public comment on the procedure so that the public has greater confidence in the system.

  387.  Could you deal in more detail with your labelling philosophy? The FDA state that the "Food, Drug and Cosmetic Act does not require disclosure in labelling of information solely on the basis of consumer desire to know." Do you consider that the consumer has the right to know? Perhaps you can illustrate this to us? I am not familiar with the practical example in the US of, say, how tomato paste is labelled if it is a 100 per cent GM product. In the case of certain products of which soya is a material ingredient, such as a pizza, does that also involve particular labelling?

  A.  First, perhaps I may explain the general policy that underlies the labelling requirements in the US. Labelling policy falls under the Federal Food, Drug and Cosmetic Act. Essentially, it requires that the labelling of products should be truthful and not misleading and it should include the common or usual name of the food. Perhaps more importantly, it requires labelling only if the end product is materially different in some respect. Our FDA has concluded after a careful review that inherently there is nothing in these genetically modified products that makes them materially different from their conventional counterparts. Therefore, we do not as a general matter of policy require that these products be labelled. If however, in future there is a particular genetically modified product that is materially different from its conventional counterpart, it has to be labelled. Two specific examples: Our FDA has required that oil derived from genetically engineered canola plants that have high levels of laurate be labelled as "high laurate canola oil", and that oil from soybean plants modified to express high oleic acid content be labelled as "high oleic soybean oil". Both of these products are significantly different in composition and use than the conventional products. However, in neither case was the product label required to state that the oil was produced through genetic modification. Similar labelling requirements were imposed on specific sunflower and safflower varieties, even though those varieties were developed through conventional mutagenesis.

  388.  You do not label GM tomato paste?

  A.  It is just tomato paste. That is because the FDA has reviewed the product and concluded that the genetically modified version is not materially different from the conventional product.

  389.  It is for the FDA to decide whether or not labelling is required?

  A.  Correct.

  390.  If, for example, an anti-freeze gene from a flounder or other fish is inserted into a plant would labelling be required?

  A.  That could be an example, but I would have to address that question to our FDA.

  391.  If there were a modification that reduced or increased fat content would that require labelling?

  A.  That sort of information is disclosed on the so-called nutritional panel on the side of the label. That covers fat and protein content but there is no specific mention of the fact that the product is genetically modified.

  392.  To return to the tomato paste, from our observation it is a different product compared to standard tomato paste. Although your FDA may say that it does not require labelling, in practice do manufacturers of that product choose to identify it as a different product—as a GM paste?

  A.  Our companies do not voluntarily disclose the fact that it is genetically modified. They are free to do that. We would support that sort of voluntary disclosure, but that is not something that the companies have chosen to do. However, if it is a flavour savour tomato, for example, they will sell that product with that sort of advertising so that people know it is a special tomato which is more shelf stable and so on. They do other things to advertise the fact that this tomato has special characteristics.

  393.  It is identified as a different product, not as a genetically modified product?

  A.  Correct.

  394.  Is that because such labelling would be detrimental to the sale of that product?

  A.  I do not know. You would have to put that question to the manufacturers. For whatever reason, they have not chosen to put that on the label. It is likely that they would do so if they thought there was great consumer concern in the US about whether or not the product had been genetically modified.

  395.  Has there been any campaigning against supermarkets who sell unlabelled genetically modified products?

  A.  There have been some but it is only a distinct minority who are in favour of this kind of labelling.

  396.  Are there any consumer organisations represented on the regulatory agencies - the FDA, EPA and Food and Drug Administration - who monitor GM organisms?

  A.  No. The agencies are wholly comprised of government officials. We have scientific advisory committees. I do not have a list of their membership. I would be happy to provide that information for the record. It may be that some of the consumer groups have representatives on those committees. But the consumer groups are free to comment at various stages, even at the stage of developing regulations or as public notice is given that various products are approved or are about to be approved.

  397.  Is it your view that a labelling requirement can constitute a barrier to trade?

  A.  It could depending on how it is constructed. For example, on the basis of the new labelling policy that has been issued by the EU it is not clear to us at this point what level of testing may be required. If the US sent a shipload of soybeans to Europe would each bin or hold of the ship have to be sampled individually or would there be one sample for the whole ship? It is not clear how intensive that sampling has to be, or what sampling methods will be sanctioned. Until all sorts of operational details are worked out we have concerns that this policy may constitute a barrier to trade.

  398.  This brings us to the question of segregation. Our impression is that the US is opposed to segregation. Is that correct, or do you accept that segregation should be decided by consumer choice? Has the US Government made any attempt to prevent segregation either at home or abroad?

  A.  What we are opposed to in the US is mandatory segregation. We have not made any attempt to discourage segregation to the extent that if a seller wants voluntarily to segregate a commodity we are not opposed to it. If a seller can find a certain market niche by advertising a product as GMO-free or whatever he is free to do that. We would support that as a voluntary measure. But in the case of mandatory segregation the issue for us is whether or not the end product is materially different. We have reviewed that issue very carefully in the US and have concluded that these products are not materially different from their conventional counterparts. We do not believe therefore that segregation is necessary. We also believe that on a broad scale segregation is impractical given the way that major commodities are produced in the US. Typically, our farmers harvest all their corn or soybeans together, put them in the same bins and move them to the same terminal elevators. It would be difficult and more costly if farmers segregated products according to whether or not they were conventional or genetically modified. However, increased segregation is occurring in the US but not as a result of whether or not the products are genetically modified; rather, it occurs because today farmers are more interested in producing certain commodities with special characteristics. In the case of corn, farmers are producing more higher oil, waxy or white corn that meet specific end-user requirements. That corn is then segregated and identity preserved in the marketplace. But typically it also commands a premium in the marketplace because it offers special characteristics. If a farmer is offered that premium for producing a different product then he is happy to segregate and give it the special handling and attention that it requires.

  399.  We were able to meet informally members of the American Soybean Association who were over here earlier this week. We learnt of some of the potential difficulties of segregation that you describe. We also learnt of the likely prospect of all sorts of different types of genetically modified soya that may be produced in future which would make segregation essential. Therefore, genetically modified products could be a vehicle for the introduction of a great variety of crops and therefore segregation would be required. Is that a likely pattern that you foresee?

  A.  Yes, I do. But we view that as a more acceptable development because the whole basis for segregation is different. The products would not be segregated simply because they were genetically modified versus conventional; they would be segregated because the end product had some different characteristic that was preferred by the marketplace. We prefer to see this develop in response to market and consumer demand rather than because of any arbitrary decision by government that these products should be segregated because they are genetically modified.