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Overview of Field Trials of Biopharmaceutical Crops Across the World

The report is best read online for all the tables, figures, references etc. and can be found at: http://www.gmwatch.org/p1temp.asp?pid=83&page=1
Aug. 2, 2006 ---

Pharma crops State of field trials worldwide [an edited version] Andreas Bauer: Umweltinstitut München e.V. - Munich Environmental Institute www.umweltinstitut.org Updated February 2006

Index of contents Introduction Field trials in the USA Field trials in CanadaField trials in Europe Field trials in other countries References

This paper is a shortened and updated edition of a diploma thesis written at the University of Kassel, Germany. The thesis was written in 2005 and is in German. The whole text can be downloaded at the Institute's website www.umweltinstitut.org

1. Introduction

Pharma crops are defined as transgenic plants for the production of pharmaceuticals (e.g. antibiotics, diagnostic compounds, antibodies, vaccines, etc.) or industrially-useful biomolecules (e.g., biodegradable plastics, engine oils, food processing enzymes, etc.), rather than for the production of food, feed or textile fibres (CFIA 2005b). Up to now, documented field trials of genetically modified pharma crops have been conducted in the USA, Canada and some European countries including Iceland. The total number of trials is about 350.

The first ever field trial of a plant producing a pharmaceutical compound took place in the USA in 1991. Today, 237 applications account for the USA, 88 account for Canada, 30 for Europe and two for Iceland. An analysis of these trials shows that most field trials were conducted between 1999 and 2001. Since 2002, the number of trials has decreased and is now back at the level of 1995.

2. Field trials in the USA

Up until 2004 more than 10,000 field trials of GM crops were conducted in US fields. More than 200 trial applications are for plants that produce pharmaceutical substances or industrial enzymes (see Annex I). Unfortunately, the US regulation system makes it very difficult to get insight into the pertinent details. For example, most information is declared to be confidential business information (CBI). In most cases, neither the donor organism the gene was taken from nor the gene itself nor the acreage of the trial is available to the public. The contamination scandal with ProdiGene in 2002, however, changed things slightly and led to a tightened regulatory overview.

Field trials of pharmaceutical crops are listed in the databank provided by the US Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) following categories:

? Pharmaceutical protein ? Industrial enzyme ? Antibodies ? Antigen ? Novel protein ? Value added protein for human consumption ? Polymer

Overall, 260 applications were sent to APHIS from 1991 to 2005. 23 of 260 applications in these categories were withdrawn or rejected by APHIS.

Development

The first ever field trial of a pharma crop was conducted in the USA in 1991 by Biosource Genetics (today: Large Scale Biology). By 2005, the number of field trials had grown to 237 in 410 different locations.

After a period of intense activity between the end of the 1990s and 2001, a massive decline of the number of trials can be seen. Tightened safety measures that came along with the ProdiGene incidents in 2002 might be one reason for this decline. There is also a lot of public pressure, especially by the food industry for greater scrutiny.

For 2006, 13 trials are announced, but still pending. No further information is available as of the end of February 2006.

Transparency

In 2002, the US National Academy of Sciences (NRC 2002) criticised the inflationary trend of declaring important information for field trials to be confidential business information (CBI). Because of this, authorities were not able to check the information provided by the companies or to do environmental assessments. The new oversight that was enforced in 2003 seems to reduce the protection provided by the confidentiality blanket (USDA/APHIS 2003). Up to this time, it was very popular to declare genes and even the source of the genes that were introduced into the plants as CBI. In 170 of 237 trials the source of the organism was declared as CBI. In 191 of 237 permits (81%), the introduced genes are declared as CBI.

Even the information that a plant produces a pharmaceutical protein or an industrial enzyme can hardly be discerned. This is mainly due to a confusing use of the different subcategories under which pharma crops are filed. Apart from the categories "pharmaceutical protein" and "industrial enzyme", some companies applied for trials of plants with a "novel protein", which doesn't allow any conclusions about the intended use of the recombinant protein. The USDA database also shows that the classification is arbitrary. In 2004, Ventria Bioscience conducted a field trial of transgenic rice expressing human lysozyme (0-365-01r). The protein is described as a pharmaceutical protein. In the same year, Washington State University conducted a trial in which the same protein was produced (04-083-08n). Here, lysozyme is filed as a "novel protein". The pharmaceutical proteins lysozyme and lactoferrin from Ventria are also redefined from the original category "pharmaceutical protein" into a "value added protein for human consumption" in 2004 and 2005.

Plants

Field trials of pharma crops in the USA took place almost exclusively with food- and feed crops. Corn was used in 154 of 237 trials. Besides that, soy, canola, rice, safflower, barley and alfalfa producing pharmaceutical or industrial proteins were grown (figure 5).

Notifications

Until 2003, applicants for field trials with pharmaceutical plants could use a simple notification to USDA/APHIS to get an admission for a pharma crop field trial. In a notification process, there is no oversight, no testing, no monitoring and no environmental assessment at all (Freese 2002). 111 trials were granted under the "notification" regime. According to representatives of USDA, notifications were only granted for proteins that posed no risks for the environment or human health, which is the case with industrial enzymes, according to APHIS. However, in 2000, ProdiGene conducted a 10 hectare trial with transgenic corn that was producing a pharmaceutical protein under the notification regime.

Acreage

An overview of the acreage of pharma crop trials is hardly possible. In 60 of 237 trials, the companies refused to announce the acreage. Freese (2002) assumes that companies worry that competitors might gain insight of how close a company is to commercialisation of the product. The remaining 177 fields account for 6230 hectares.

In contrast to the declining trend for field trial applications, the acreage used for trials increased and peaked in 2004 (figure 3). This is mainly due to a number of trials with huge acreage conducted by Pioneer Hi-Breed. In 2005, a massive decline in the size of trials took place.

Companies

In the USA, 95% of all field trials have been conducted by commercial companies. 87 applications have been sent in by ProdiGene.

3. Field trials in Canada

In Canada, field trials with pharmaceutical crops started in 1994. The information for the time between 1994 and 1998 only provides information about the number of trials.

Since 1998, more information is added: Name of institution Plant State where the trial is conducted Type of protein

However, the Canadian government doesn't give any information about the inserted gene, or the size of the trials (Annex 3). Until 2005, 88 trials with pharma crops have taken place (CFIA 2005a).

Plants

Unlike in the USA, fewer food and feed crops like corn, soy or rice were used in the Canadian trials (figure 9). On the other hand, there is an amazing number of trials with canola producing pharmaceutical compounds. 15 trials with canola were conducted from 1998 to 2004 by the University of Calgary. There are no documents for the time between1994 and 1997, but according to Freese (2002) there were more field trials of canola expressing pharmaceutical proteins. At least some of these were conducted with canola expressing Hirudin, a bloodthinner.

In the last few years, there seems to be a shift towards plants expressing industrial enzymes rather than potentially dangerous pharmaceutical proteins (see Annex 3). Details about the genes are not provided by the Canadian Food Inspection Agency (CFIA).

4. Field trials in Europe

Field trial trials of pharma crops have taken place in Europe since 1995, according to the European data bases (BVL 2005, JRC 2005). 30 trials of pharmaceutical crops were conducted in Europe through 2005 (figure 11). Most trials took place between 1995 and 1997. There were only a few applications from 1998 onward (see Annex 4).

The development is synchronic to the collapse of field trial applications for other GM crops during this period, which probably is due to the moratorium and the rejection of GM crops in Europe. As in Canada and the USA, the majority of trials took place between 1995 and the end of the century.

Since that time, there has been a decline in the number of applications. However, the end of the moratorium in Europe might result in a rise of field trials with pharmaceutical crops. In 2005, the first year since the moratorium came to an end, there was an increase of new applications. A similar development can be seen in the acreage used for field trials (figure 12). In the years 2002 to 2004, the acreage was nearly zero. In 2005, pharmaceutical crops were grown on 23,6 ha. For 2006, the first ever field trial with a crop producing pharmaceutical compounds, is to be conducted in Germany.

Most European deliberations have been conducted in France. France is home of "Meristem Therapeutics", one of the biggest players in the pharma crop sector. Biocem/Limagrain also conducted several trials. Other trials took place in Spain, Germany and Italy (figure 13).

Acreage

Despite the number (30) of trials, the acreage used is not very large. Taking into account that some trials were conducted over many years, the acreage used amounts to only 200 hectare. But some substances involved are already in the state of clinical trials, and, if they are approved, could therefore be required in larger amounts in the near future. In that case, the acreage will increase considerably in the next few years. In 2005, large scale field trials of pharmaceutical corn were conducted by Meristem Therapeutics. This corn contains a dog gene which expresses the protein dog gastric lipase (DGL) (figure 13).DGL is in stage II of clinical trials and intended for the treatment of mucoviscidosis.

Transgenic corn producing this substance was grown on 21,1 hectare in 6 spots in 2005. The harvest will be used for the third clinical stage. The required distance to the next corn field is only 200 meters, according to the official documents (OGM 2005a).

In 2005, the first European trial with a pharmaceutical plant that produces monoclonal antibodies took place. Meristem Therapeutics is growing antibodies RM 2 and 3 in transgenic corn in France. The aim of the trial is to get enough antibodies to conduct clinical trials of stage I and II (OGM 2005b). According to the French advisory commission, there are no detrimental effects on human health or the environment.

Substances

In contrast to the trials in France, Italy and Spain, the three trials that took place in Germany are focused on the production of industrial enzymes in plants. The three field trials, conducted by IPK Gatersleben, are intended for the production of spider silk in potatoes (B/DE/02/146, B/DE/04/160) or the production of YÑ-amylase in transgenic peas (B/DE/99/114). However, the interest of the European developers seems to be focused on pharmaceutical proteins. Only four out of 30 trials were intended for the production of industrial enzymes.

Plants

In most trials in Europe, tobacco was chosen as production platform. All trials with pharmaceutical tobacco were conducted by Biochem/Limagrain in the 90s, Apart from tobacco, all other trials were done with food and feed crops (figure 15).

5. Field trials in other countries

Not documented trials

Apart from those trials documented in North America and Europe, we don't know much about the existence of field trial trials with transgenic crops producing pharmaceutical or industrial compounds. There's a huge lack of documentation and transparency in many countries of the world.

Two field trials with GM barley are being conducted in Iceland (Kristinsson 2005). According to Gunnarsson (2006), the public has no knowledge about the genes that were spliced into the barley plants. One trial started in 2003, the other in 2005...

By their own account, Meristem Therapeutics conducted field trials with pharma crops in Chile (Martynoff 2005). According to Cummins (2005), field trials have also taken place in China. Researchers have stacked genes for the highly toxic substance Trichosanthin into transgenic rice. Tokar (2001) quotes statements from Stauffer Seeds Company (a ProdiGene merger partner) that they have conducted trials in South America, the South Pacific and the Caribbean.

Future trials

The number of field trials will probably go up in the next years. For example, trials are announced by the European "Pharma-Planta" consortium. Because of the rejection of GM crops in Europe and because of the high costs for security measures, the trials with transgenic tomatoes, maize or tobacco will be conducted in South Africa (Lindow 2004).

In southern countries like South Africa, there are no laws concerning GM crops and no legal framework to ensure biological safety. Therefore, field trials there are cheap. In 2002, a lobby group (Molecularfarming 2005) established a database for farmers who want to grow pharma crops in the future. The Website attracts farmers with boosting prices for their products. Farmers from Brazil, Zimbabwe, India, Pakistan, Panama, Nigeria, Tunis, Malawi, Philippines, Lebanon or Guinea have already subscribed as future producers. Most of these countries are hot spots of biological diversity.

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