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-----Original Message-----
From: Biotech-Mod1
Sent: 28 May 2003 10:03
To: 'biotech-room1@mailserv.fao.org'
Subject: 82: A few observations on the debate

These comments are from Dr. Peter W.B. Phillips, NSERC/SSHRC Chair in Knowledge-based Agri-food Development. Member of Canadian Biotechnology Advisory Committee and co-chair of the review of the Canadian regulatory system for GM foods (released Aug 2002) [Entitled "Improving the Regulation of Genetically Modified Foods and other Novel Foods in Canada", available from http://cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwGeneratedInterE/h_ah0009 4e.html ...Moderator].

Let me start by suggesting that part of the difficulty of debating regulation is defining the rationale. As an economist, I tend to the view that governments should restrict their actions to areas where there are demonstrated market failures (which could mean inadequate private regulation, unacceptable market power, unacceptable distributional effects ...) and where the actions they take address and have some chance of ameliorating the market failure.

In that context, I am somewhat concerned about the view that regulation of biotechnologies in the food system should be expected to handle a wide range of posited market failures related to: health and environmental safety; industrial structure; economic and distributional impacts; social impacts; and moral aspects. I tend to the view that if we have multiple problems, we probably need multiple policy tools.

Now, let me relate this to the core of this discussion, which is what advice could we give to countries (mostly developing) which do not already have regulatory systems for GM foods.

1. Public health and safety should be the prime motivator for regulations specifically related to GM foods: In that context, I think that more discussion could be undertaken on what an appropriate distribution of local versus non-resident evaluation might be. Keep in mind that risks are examined in a methodical way and are commonly defined as hazard x exposure.

- In the first instance, I think there is a good base for common methodological assessments of risk. The methods of assessing food safety risk have been well articulated in the oft mentioned Codex Guidelines. Relying on and using those would be a wise first step.

- Second, I would argue that the characterization of the hazards related to GM food is unlikely to vary greatly by population or ecosystem, and as such is likely appropriately characterized well once and then incorporated into population or ecosystem analyses. Canada and the US, for instance, have Mutual Recognition Agreements on using some characterization data, while the Organisation for Economic Co-operation and Development (OECD) has developed consensus documents on the biology or characterization of certain events, which are then accepted and used by many regulators. On the food side, the critical hazards are toxicity, allergenicity and compositional change while invasiveness, outcrossing and potential hazard to non-target organisms (e.g. monarch butterflies) would be examples of the hazards that need to be characterized. In short, one good characterisation is undoubtedly better than many partial or poor efforts. Hence, international harmonization should be the standard here.

- Exposure levels, in contrast, are usually locationally specific. The challenge is to determine the critical level of exposure before a hazard can be observed to happen. Between populations, diets and susceptability to allergens can vary widely. Similarily, the impact of a new trait cultivar could vary widely depending on the indigenous flora and fauna and on the nature of the cultivated and uncultivated areas, and their interaction. In some cases, the structure of the industry and the institutions may influence exposure levels. All of these could be locally assessed or, perhaps more appropriately, health exposures should be assessed within a cultural/economic/social population (which in some areas of the world could be smaller than a state or in other areas encompass many states). Similarily, exposures and risks of release of organisms will seldom respect geopolitical boundaries and should be evaluated at the ecosystem level, which may be larger or smaller than a state.

This is a long exposition to simply argue that regulation of the health and safety aspects should rely fundamentally on internationally characterised hazards, generally accepted methods and locationally relevant assessments of exposure. To this end, developing countries should consider regional assessments (e.g. amazonian rain forest). In many cases there is pre-existing capacity to undertake some of the science in many of the Consultative Group on International Agricultural Research (CGIAR) centres located around the world. That would likely make assessments more effective (e.g. reduce type 1 errors, such as releasing a risky organism) at a lower resource costs. [In statistics, a type 1 error means we reject the null hypothesis when it is true; a type 2 error occurs when the null hypothesis is false but we fail to reject it...Moderator].

2. Most other aspects that concern people about GM foods--e.g. industrial structure; distribution of winners and losers; social impacts; moral aspects--while raised in the context of GM foods are not unique to GM foods and probably are better handled in the context of a broader development policy. Adding them to the health and safety regulations raises the risk that type 1 (risky) errors will be made (simply because the method is flawed or tradeoffs are undertaken by regulators), or alternatively, that type 2 errors (rejecting safe and possibly beneficial advances) may be compounded. Both are likely to be major problems for developing countries.

Professor Peter W.B. Phillips,
Department of Agricultural Economics
51 Campus Drive
University of Saskatchewan
Saskatoon, SK S7N 5A8
Canada
phillips (at) duke.usask.ca