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   WB01343_.gif (599 bytes) Pesticide and Environmental Update

The Failure of the first GM Foods

Summary: Flavr Savr tomatoes were the first fresh genetically modified fruit or vegetable sold in the world. It was marketed in the US and approved for sale in the UK, though never sold here. However, Flavr Savr was a commercial, and possibly safety, mistake.

Though many of the US Government’s own scientific advisers were concerned over findings showing possible negative health effects, the US approved the GM tomato and decided that GM foods in general would not reqirement pre-market approval in the US. There were other problems: Calgene made major management mistakes; it was subject to heavy legal pressure from Monsanto; and the GM tomatoes were even more bland than conventional fruit. The tomatoes were only ever sold in a small number of outlets in California and the Mid-West, and then rapidly withdrawn.

At the same time Zeneca had developed a GM tomato for use in puree. This initially sold well in the UK as it was sold cheaper than non-GM puree. However, following publicity over safety concerns, the GM puree was also withdrawn.

1. ‘Conventional’ Tomato Production About seventy million tonnes of tomatoes were produced worldwide in 1993. Today's global food distribution system involves food being transported many miles and hours between producer, processor, retailer and consumer. It is important that ripe fruit and vegetables do not perish on the journey due to their soft skins. In the US, the problem is solved in conventional tomato-farming by picking tomatoes while they are still green and firm, transporting them, and then spraying them with ethylene (the natural ripening agent) to artificially ripen and redden them after the journey. 80% of American tomatoes are managed in this way. However, artificial ripening does not produce the flavour that the fruit has if left on the vine, and they are usually quite tasteless.

2. Development of the GM tomato and GM tomato puree Calgene, a small biotechnology company in California, decided to genetically modify a tomato that could be picked when ripe and transported without bruising. The tomato is relatively easy to modify genetically, and it was hoped that this experience of manipulating tomato ripening could be used for other fruit. Professor Don Grierson initiated a research group in the mid-seventies at the University of Nottingham in collaboration with Zeneca with this in mind.

By late 1991, after ten years of development, Calgene had developed the Flavr Savr, a ‘delayed-ripening tomato’. They claimed it would have a longer shelf-life than conventional tomatoes and would provide processors and consumers with tastier tomatoes because the fruit had been left to mature on the vine. They had used antisense technology, a method of gene-silencing which interferes with the production of specific proteins in the plants. The biotechnology companies were very optimistic in the early nineties, believing that the supermarkets would soon be widely selling GM food.

Calgene asked the US Food and Drug Administration (FDA) to approve the product who unreservedly gave the green light to its widespread growing of Flavr Savr. In 1993, public concerns about the safety of GM food led to Calgene asking the FDA to provide a ruling that GM foods are ‘safe’, particularly with regard to the tomato’s antibiotic resistance genes (Flavr Savr carries the gene for resistance to the antibiotic kanamycin), which they provided in mid-1994.

Calgene was only one contender in the race to create the ‘perfect’ tomato. At this same time, soup giants Campbell’s were supporting Zeneca’s (now AstraZeneca) attempts to produce a GM tomato. The three organisations were on the verge of legal action against each other when a compromise was reached in February 1994: Calgene would have the world-wide rights to sell the fresh-market types of the new tomato, while Zeneca would focus exclusively on processing tomatoes.

Zeneca developed its first GM product by modifying a tomato to make it bulkier with reduced water content, therefore increasing viscosity and making it more suitable for puree or soup. It grew the first of these crops in California in 1994. In 1996, following FDA approvals, Safeway and Sainsbury's agreed to sell the world’s first GM tomato puree in the UK: Zeneca tomatoes made up Safeway Double Concentrated Tomato Puree; Produced from Genetically Modified Tomato and Sainsbury’s Californian Tomato Puree; Made with Genetically Modified Tomatoes.

It arrived in the supermarkets in February 1996. The GM puree cost 29p per 170g while conventional puree cost 29p for 142g. The supermarkets priced this new GM product very carefully. The reduced processing costs of the more viscose tomato allowed for a lower shelf price, but the supermarkets did not want the product to be seen as 'cheap' and therefore of lower quality. So, it was never sold alongside non-GM tomato paste in the same size container at a lower price. Instead, it was always sold in larger containers alongside the smaller containers of non-GM paste, and at the same price, thus making it look 'better value' but not cheap. According to Safeway and Sainsbury’s, initial sales were ‘brisk’. By November 1997, Safeway announced that they had sold 750,000 tins and average sales per store were greater than those for the conventional product. By 1999, the GM puree had captured up to 60% of the tinned tomato market share and was hyped a runaway success.

Several other companies are trying to develop GM tomatoes: Agritope, Aventis, DNA Plant Technologies, and Seminis. DNA Plant Technologies and Monsanto sued each other over patent infringements. Before Monsanto triumphed, DNAP test-marketed a tomato called Endless Summer in New York, but was then bought by ELM in 1996. However, neither company has marketed GM tomatoes since. Agritope, gained approval from the FDA in 1996 for a GM tomato but is not ready to market it. 3. Health Concerns Concerns over the safety of GM foods from the public and scientists, on top of many business management errors (see next section), resulted in the eventual failure of both GM tomato products.

These GMOs were the only GM foods for which the FDA has considered requiring pre-market approval. Both tomatoes contained marker genes that gave resistance to the antibiotic kanamycin which is used in medicine. People were concerned that if the genes passed out of the tomatoes and entered bacteria, the bacteria could develop resistance to the antibiotic, undermining its medical effectiveness. The question was referred by Calgene to the FDA who used Flavr Savr as a GMO test case. They approved Flavr Savr and Zeneca’s similar product in mid-1994. In doing so they decided that GM foods in general should not be regulated differently to non-GM foods and would not require pre-market approval. Unlike food additives, for which pre-market approval is required in the US, they argued that GM foods are the same or substantially equivalent to non-GM foods. However, there was actually no scientific evidence that the tomatoes were safe for human consumption. In fact, the FDA had ignored many of its own scientists who were concerned that research had shown that GM tomatoes had a potential to cause stomach lesions.

Calgene had carried out three 28-day studies. Groups of rats were fed either a GM tomato, a non-GM tomato, or deionized water. Some of the studies revealed statistically significant differences between the effects of the GM and non-GM tomatoes. While one study showed no problems, in the second gross lesions were observed in four out twenty female rats fed one of the two lines of transgenic tomato. In the third study gross and microscopic lesions were found in the rats. These findings, however, was played down and not publicly communicated by the FDA.

While some scientists blamed the study methodology and argued against using animal feeding trials to assess GMOs, many FDA scientists questioned the safety of the tomatoes and the way the FDA management was handling the approval of GMOs. In a memo dated 16 June 1993 to Linda Kahl, Consumer Safety Officer at the FDA, Fred Hines, Staff Pathologist at the FDA wrote: “There is considerable disparity in the reported findings of gastric erosions or necrosis lesions from the three studies provided by Calgene Inc. This disparity has not been adequately addressed or explained by the sponsor or the laboratory where the study was conducted … The criteria for qualifying a lesion as incidental were not provided in the Sponsor’s report.”

In an October 1993 memo, the Director of Special Research Skills at the FDA suggested that the Flavr Savr safety experiments were “hardly strong evidence that gastric erosions are random and highly variable … the sponsor (Calgene) admits that no cause for the lesions is established … the data raise a question of safety”. The Additives Evaluation Branch added in December 1993 that “the responses Calgene provided were insufficient to answer the questions that still remain”.

In 1994, Dr Joseph Cummins, Emeritus Professor of Genetics at the University of West-Ontario warned that the inclusion in Flavr Savr tomatoes of a genetic sequence from the Cauliflower Mosaic Virus could create virulent new viruses. In October 1991, Dr Edwin Mathews from the Department of Health and Human Services and of the FDA's Toxicology Group wrote to the FDA Biotechnology Working Group saying: “Genetically modified plants could also contain unexpected high concentrations of plant toxicants”.

The FDA was obliged to reveal these internal views in 1998 only after a lawsuit filed by consumer groups, scientists and others (Alliance for Bio-integrity) in which it was accused of ‘failing to fulfil its regulatory duties’. Despite the safety concerns, Flavr Savr was also cleared for sale in the UK but never marketed.

4. Economic Problems Flavr Savr tomatoes were sold under the MacGregor’s brand name and identified as GM when they arrived in US shops in summer 1994. They sold relatively well at first and were in 2500 stores by June 1995. But this did not last and they were withdrawn less than a year later. As well as the safety concerns, they cost about twice as much as non-GM tomatoes, had no better flavour, and were prone to bruising.

Calgene was a small company and accrued large debts while developing Flavr Savr. As well as legal battles with Monsanto, it made major mistakes. During the research stage, it used a tomato more suitable for processing than direct eating which bruised relatively easily - the direct opposite of its intention. The tomatoes were also bland, instead of being more tasty. Furthermore, Flavr Savr was developed in California: when production was moved to Florida, it was profoundly unsuited to the sandy soil and humidity, and so susceptible to fungal diseases among other problems. It was already deep in debt when Calgene was then hit by higher production costs and low world tomato prices. In the end Monsanto finished off Calgene by claiming ‘patent-infringement’ and buying it out.

Flavr Savr tomatoes were never sold outside California and a few outlets in the Mid-West. Despite the safety concerns, they were cleared for sale in the UK but never marketed. In 1996 Safeway said there was ‘no question of importing Flavr Savr’ to the UK and Sainsbury’s echoed this by claiming there were ‘not enough benefits to justify stocking Flavr Savr’. Fresh GM tomatoes have never been sold in the EU.

The last can of AstraZeneca paste was sold in the UK in June 1999. The product failed because of the safety concerns and economic failure. A decision to not invest in tube packaging rather than tins, which are used for tomato puree in the US, has been blamed but the high sales show this was not an issue. Despite the significant price reduction, overall sales were only 25% higher than the conventional product which was not enough to make the product worthwhile. Moreover, the association of tomatoes and GM, resulted in a slump in sales of all own-label tomato based foods in all supermarkets, so there were large sales losses. The biotechnology company made no profit from the product and, like Monsanto, its stock continues to plunge.

Footnotes:

1. NLP Wessex website 2. Ngin website 3. Union of Concerned Scientists website 4. ‘The Story of the Flavr Savr Tomato’ – dragon.zoo.utoronto.ca/~jlm-gmf/T0501D 5. www.i-sis.org.uk – Biotech debacle in four parts 6. Mendels kitchen – www.balwynhs.vic.edu.ac 7. www.bbc.co.uk – GM food history 8. www.comm.cornell.edu/gmo – general history and science 9. www.emory.edu – general history and information 10. www.hort.purdure.edu – lecture on tomatoes 11. www.reuters.com 12. www.organicconsumers.org – recent developments 13. www.thescientist.com 14. FDA Center for Food Safety and Applied Nutrition (CFSAN), Dr Laura Tarantino, Deputy Director of Office of Pre-market Approval

 

 

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