This paper analyses how different institutional structures shape the research and development (R&D) of GM crops. Whether this R&D is conducted within private companies, cooperatives or public research organisations is expected to influence the type of crops and traits that are developed and therefore the effects on society and ecosystems that potentially could follow from the use of GM crops. The fact that crops are biological products that are easily reproduced imply certain obstacles for creating the necessary economic returns in markets.
Company research does therefore require products with some kind of excludability. Legal means to secure profits like plant variety protection, patents, and contract growing provide incomplete, protection for GM seeds (Srinivasan and Thirtle, 2003). I therefore expected company research to focus on R&D that makes crops biologically excludable to secure return on private investments. Biological means for making crops excludable include the development of v-gurts (terminator seeds), hybrid seeds, and herbicide-tolerant crops that are developed by an organisation that also market the particular herbicide. I further expected company research to focus on crops and traits that are widely demanded and crops and traits that can be developed at sufficiently low costs. Public research organisations were expected to be more likely to focus on issues that are external to the market like environmental and food security effects than the other types of R&D organisations.
4 University-employed scientists that have some industry funding or are purely industry funded, and industry-employed scientists.
These issues are analysed empirically by statistical analysis of 1323 notifications for field trials with GM crops that have been submitted under two EU Directives in seven European countries. By five logistic regression models I examined whether the share of biologically excludable crops, the share of crops that is widely grown, the share of traits that are inexpensive to develop and the share of biosafety research depends on the interest and the country that are involved in the R&D of GM crops. I also included the time period when the notification was submitted. ‘Interest’ refer to different combinations of type of organisation (company, cooperative, public research organisation) and funding (private or public) and include ‘company’, ‘cooperative mix’5, ‘public mix’6, and ‘pure public’7
Generally, the analyses of the models supported the hypotheses. Exceptions were that
‘cooperative mix’ not differ significantly from ‘public mix’ for crops that are made biological excludable by biotechnology and crops that are widely grown, that ‘public mix’ not differ significantly from ‘pure public’ for crops that are widely grown and traits that are inexpensive to develop, and that ‘cooperative mix’ does not differ significantly from ‘pure public’ for traits that are inexpensive to develop. For biosafety research there is one significant difference between the interests. ‘Company’ differs from all the others. Hence ‘company’ stands out as the interest that always come out different from the other interests, while the other interests sometimes differ significantly from each other and sometimes not. Another important finding is that only 3 percent of the notifications concerned no other purpose than biosafety research.
) I expected the share of excludable GM crops that are widely grown and/or include traits that are inexpensive to develop to be greatest in companies, followed by ’cooperative mix’, ‘public mix’, and ‘pure public’. I expected the share of biosafety research to be greatest in ‘pure public’, followed by
‘public mix’, ‘cooperative mix’ and ‘company’.
These results indicate that consideration of the environment, food safety and food security might justify institutional reforms of R&D of GM crops. Biological excludable crops might increase agricultural weed-management problems and affect food security negatively if the supply of seeds to farmers is hampered. Increased biosafety research is important to produce knowledge about negative effects on the environment, food security and food safety of GM crops. These reforms might include increased public funding combined with less use of legal means to secure profits.
5 R&D projects that have some kind of cooperative involvement. Cooperatives are included in this category because the database contains only a few pure cooperatives.
6 R&D projects that have both public and private involvement.
13 Paper 3: Regulating the Release of GMOs: Contrasts between the European Union and Norway
This paper analyses how the type of regulation for marketing of GMOs influences which GMOs that are commercialised. The EU and Norway have assessed the release of GMOs as commercial products quite differently. Of 24 notifications approved by the European Union between 1993 and 2007, Norway has approved 4, rejected 10, and has 10 pending. We examine whether these differences could be explained by different value judgments made in the formulation and implementation of regulations for commercialisation of GMOs. Three aspects are discussed: the effects to be prevented and encouraged, response to uncertainty and ignorance, and the burden of proof. An important implication of uncertainty and ignorance is that value judgments concerning how the burden of proof should be framed become crucial for decisions on GMO release. Proving harm and proving safety may be impossible. Finally, we analyse how these value issues are treated, i.e. whether they actually are treated as value issues or merely as technical issues.
The methods used are analyses of public documents and interviews with civil servants in the European Commission and Norway. The Norwegian and the EU regulations require that those who want to release GMOs into the environment should submit a notification that contains a prior risk assessment of health and environmental effects. The two regulations are, however, unclear on which health and environmental effects that is unwanted. The prior assessments that have been undertaken in the EU and Norway include almost the same health and environmental effects. Some of the properties of the GMOs are, however, evaluated as more harmful for health and environment in the Norwegian decisions than in the EU decisions. The Norwegian regulation also requires that effects on sustainable development and benefits to society should be evaluated and it has been concluded that the notifications provide no real benefit to society.
The Norwegian regulation emphasises that the existence of uncertainty and ignorance direct against approval while the EU regulation is unclear on this. In all the 24 EU approvals, it was concluded that there is no reason to believe that there will be any adverse effects on human health or the environment. The Norwegian government has made a similar conclusion in three of the approvals, while they have rejected most of the cases, by emphasising lack of scientific knowledge. Hence, the Norwegian decisions and the EU decisions have responded quite differently to uncertainty and ignorance.
The burden of proof applied is similar in terms that the notifiers have to provide tests or studies of certain harmful effects. The authorities have then decided whether these studies
are sufficient. In all of the notifications, the notifier has concluded that the tests have not identified any harmful effects. The EU authorities have defined these tests to be sufficient, while the Norwegian authorities have only found the studies to be sufficient in three of the approvals.
The combination of no real benefit to society, lack of scientific knowledge, and involved risks explains the Norwegian rejections, while the main explanation for the EU approvals is that they saw no reason to believe that there would be any adverse effects on health and the environment. In the EU, several value issues are decided on by experts, while the Norwegian decision-making procedure has, to a greater extent, treated decisions on the release of GMOs as a value issue. The problem is not that value judgments may differ. What is problematic is when procedures are such that value judgments are treated as technical issues and conducted by experts.