The recent furore over pharma field trials in France, involving the production of monoclonal antibodies, is put into perspective by this useful report on pharma field trials around the world. This report also shows that the French field trials involving monoclonal antibodies actually got underway a year ago.

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

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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 n