Select Committee on European Communities Minutes of Evidence

Examination of witness (Questions 421 - 434)



  420.  If the product became a problem why would it be difficult to sue the manufacturer?

  A.  It would not be difficult to sue, but I do not know how a court would rule in such a case. I cannot prejudge the outcome of a lawsuit.

Lord Rathcavan

  421.  Just now you referred to various ways in which you assess risk. As I understand it, the US Government decided that there should not be special legislation to assess the safety of the products of biotechnology. How adequate or useful do you consider your pre-commercialisation risk assessment to be? What can usefully be judged in the four and a half months which the US took to assess Monsanto's pest- resistant corn or the eight months to assess the herbicide-resistant soybeans? You are probably aware that there has been great concern in Europe about the resistance to antibiotics which is potentially involved in one particular pest-resistant corn, although many believe that the risk is minimal. Perhaps it would be useful to hear how the US system assesses this risk for that BT maize or pest-resistant corn. Undoubtedly, there was great public concern that in some way immunity to antibiotics could enter the food chain?

  A.  The role of pre-commercialisation testing and research is very important. Typically, before the sponsors of these products approach the US Government and ask for commercial approval they conduct at least a couple of years' worth of field testing. That field testing is done under standards prescribed by the federal agencies that will ultimately review the product. You mentioned the number of months that a product is before the different regulatory agencies. As I understand it, that simply refers to the period of time during which that final stage of the process occurs where the company has completed its couple of years' field testing and is now providing the data to USDA or EPA to get approval to move on to the commercial phase of production. It is not as if those products are examined for only four or six months. That is just the final stage of the process prior to full-fledged commercialisation. In the case of antibiotic markers, a lot of attention has been focused on that issue. That issue was examined by the French during their consensus conference three or four weeks ago. It has also received careful scrutiny in the US. It looks as if most of the scientists who have examined the issue are confident that the procedures are safe. But I believe that the companies are aware of the sensitivities in this matter and for that reason seem to be interested in other alternatives as new products are submitted in the future.

Lord Redesdale

  422.  You said that the final stage of field testing was undertaken by the individual companies. Are those field trials attended by independent scientists who verify the results or is it done specifically by the company and you take the results submitted by the company?

  A.  I cannot tell you about the exact procedures. All I can say is that the test protocols are laid down by our federal agencies at the start. The companies have to follow those protocols. Whether or not the federal agencies send out people to make sure that those protocols are followed I am not able to say today.


  423.  Does the USDA or any other agency require any follow-up monitoring after commercial release of particular crops?

  A.  We generally require monitoring, unless a product has been deregulated. Companies are required to notify the federal government of any adverse findings that may be discovered. To cite a specific example, our EPA has required monitoring for Bt-based crops, primarily to monitor for insect resistance.

  424.  Does that requirement rest on the company that provides the seed to the farmer?

  A.  The company or anybody who may experience adverse findings. The company is obligated to report that to the government.

  425.  Is that a statutory requirement? If any ill-effect was subsequently discovered and not reported, the person who should have notified it but did not would be pursued and prosecuted?

  A.  It is more a regulatory than statutory requirement.

  426.  The farmers and companies are told what they should be monitoring?

  A.  That is my understanding. I believe that that information is explained in the detailed answers to the other questions that I have submitted.

  427.  Perhaps I can link the question of risk assessment to one matter we discussed earlier; namely, the possibility of an international convention. Is there not a need for some internationally agreed worldwide standard for risk assessment; otherwise, who will decide on the validity of the assessment? Does every importing country have to accept the risk assessment of every exporting country, or how should it be regulated?

  A.  I do not know that there needs to be an international standard for everything, but I believe that the burden on either the exporting country or the importing country that challenges the product is to demonstrate whether or not sound science has been used. I think of the other current issue between the US and EU over hormones used in beef production. The US believes that the science is very clear. We have provided all the information to the WTO, for example. The burden is on those who would challenge that decision to prove that somehow the science is flawed. After examination it has been proved that with respect to hormones in beef science is on our side. The burden tends to shift depending on who is raising the challenge.

Lord Gallacher

  428.  What crops or animals are now being worked on as regards genetic modification? Will the present focus of benefit to farmers continue? Are modifications at present benefiting US consumers, and will that also continue?

  A.  If I may, I would like to provide the Sub-Committee this morning with a list of all the various products that have been approved and are available to the marketplace today, as well as a list of products that are likely to be available over the next six years. This list is publicly available on the web page of an organisation called the Biotechnology Industry Organization. Basically, it is made up of all the companies that are active in this area. If one goes through the list one sees that 40 or more products are currently available to the marketplace today. Some of those offer direct benefits to consumers. Looking at the products, they include: tomatoes; carrots; sweep peppers; cherry tomatoes; and high-oil soybeans. There is an enzyme that is used in approximately 60 per cent of all hard cheeses. In the case of tomatoes, there is longer shelf life or improved taste. They offer direct benefits to the consumer. But I argue that even in the case of some of the other commodities like corn and soybeans, where it appears that the benefits accrue only to the producers, the public as a whole benefits to the extent that use of these products has resulted in reduced pesticide and herbicide use. We all benefit from that improved environmental stewardship. One does not necessarily have to taste a sweeter tomato or something of that kind in order to realise some of the benefits of this technology. Looking to the future, some of the other products that the industry say will be available six years from now include improved cotton varieties with stronger fibres that reduce pollution from dyes; a number of high-oil products, whether it be corn or soybeans; sweeter tomatoes and strawberries; seedless melons; controlled ripening in bananas and pineapples; firmer peppers; sweeter peppers and peas. The list goes on and on. I would be happy to provide that list to the Sub-Committee. (See Appendix to Supplementary Memorandum).

Lord Moran

  429.  Does that include work on animals? So far you have spoken only about plants.

  A.  The only mention I see here of animals are some fish: salmon, trout and flounder. Basically, they grow faster as farm-raised fish.

Lord Willoughby de Broke

  430.  What is the increased growth rate?

  A.  It is only a paragraph which refers to fish being capable of growing to market size in one to one and a half years as opposed to conventional techniques that require three years.

Lord Rathcavan

  431.  The last question was aimed at discovering who benefited more—the consumer or farmer. Quite a lot of our evidence reveals that the view of people is that it is Monsanto who benefits most rather than the consumer or farmer. There is quite a strong feeling about the monopolistic role of Monsanto in the development of GM technology. We heard about Monsanto dominating the cotton business in China and buying up companies in this business. Does Monsanto's monopolistic position in GM crop technology concern you?

  A.  It is interesting and ironic that Monsanto is frequently put up as a kind of straw man on this issue. From my experience, we deal with a number of companies including European companies. Representatives of Novartis and Agrevo come to see us on a regular basis with respect to GMO commodities for which they seek approval in the US. Certainly, European companies are very active in this area, as they should be. It is a bit of a puzzle to me why Monsanto is always held up as an example. That said, I agree with your observation that there is concern about the level of consolidation that is occurring in this industry. We see various companies either buy out each other horizontally in the development of these products or move to the next stage and buy out and consolidate the various seed companies. There is concern about increased market concentration. But today even with these acquisitions there is still a fair degree of competition, in part because European and other companies are very active in this area. Farmers are right to be concerned about the direction in which things are moving and whether or not a sufficient level of competition will be present in the industry in 2010, 2020 and that sort of timeframe.

  432.  We heard from the American Soybean Association about farmers' reduced freedom when growing modified soybean crops and the amount of litigation that is threatened if they do not conform to the standards set by Monsanto in this area. Is your department aware of the reduction in the freedom of farmers to produce crops as they want?

  A.  We are certainly not there yet. Today, farmers still have plenty of choices in the marketplace. Genetic modification technology offers the potential dramatically to increase choice, so long as there are a number of companies engaged in developing these products and offering them to farmers. There is nothing inherent about genetic modification that is spurring the concentration that we see occurring. If you look at the history of hybrid corn development over the past 50 years, a concentration has occurred in that industry. One can make the case that maybe hybrid corn is bad too. I do not think that anyone is ready to reach that conclusion. There is nothing inherent in this genetic technology that indicates that there is a problem, but farmers have a legitimate concern about the current rate of acquisitions and concentrations that occur. But at least in the US farmers for the past 100 years have always been concerned about monopolies and concentrations within agriculture, whether it is in railroads, meat-packing or grain companies. They are always worried about maintaining a level of competition with respect to where they buy their inputs or sell their final product.

Lord Willoughby de Broke

  433.  I want to pursue the question of herbicides and pesticides. With non-GM crops farmers have traditionally had a wide range of companies from whom they buy their supplies. As I understand it, nearly all the GM companies link their products with their own herbicides. People are told that they must use their herbicide with their seed; that's what the product's designed for. I was not at the meeting with the American Soybean Association, but I imagine that that is the sort of concern that it raises. Is that a matter of concern to you?

  A.  I do not perceive it as "must use". However, as a practical matter if one is buying round-up ready soybeans one is buying that product so one can use the round-up herbicide in conjunction with it. It is not a question of "must use"; if one is buying that particular seed one is buying it so one can use it in conjunction with round-up ready. As the patent on round-up expires in a couple of years I assume that it will be a generic herbicide. Others can produce it and farmers can buy it from other companies.


  434.  That brings us to the end of our questions. You have answered them very fully and clearly. We are extremely grateful to you for having come to see us.

  A.  Thank you for the opportunity. I view it as a special honour to be here today.

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