Forum Conf 1 (biotech and crop sector)

A further comment on Dr Bucchini's remarks [17 April], and specifically the question about developing countries: "Are they willing to take higher risks than their developed counterparts?"

This question perhaps expects the answer that if they are, they should not be. That answer would be wrong.

It is for developing countries to decide what they want to do (they will get plenty of advice - and pressure - from all sides of the debate). However, generally, risk-avoidance is a privilege of the rich and fortunate. If you are rich, you can buy health insurance - if poor, you must hope to avoid getting ill. Developing countries have more problems and less resources than developed countries, and inevitably are exposed to more risks. They are justified in taking bigger risks to overcome bigger problems. They would not act in the best interests of their peoples if they took an absolutist view of risk and refused to entertain solutions which (while not risk-free) offered the best available chance of solving those problems.

Of course, significant risks that might be attached to introduction of specific GMOs must always be carefully assessed. But the result of the assessment should not be decided in advance.

Tim Roberts, UK

[To contribute to this conference, send your message to biotech-room1@mailserv.fao.org For further information on the Electronic Forum on Biotechnology in Food and Agriculture see http://www.fao.org/biotech/forum.asp ]

-----Original Message-----
From: Biotech-Mod1
Sent: Wednesday, April 19, 2000 10:07 AM
To: 'biotech-room1@mailserv.fao.org'
Subject: Re: Bt, risks and developing countries

A number of comments on my mail of 17 April were recently posted by Edo Lin [18 April], whom I thank for bringing to the mailing list's subscribers attention my comments on Cry9 and providing links for the ones interested.

Some of the points raised might have a general interest.

1) The US regulatory system and biotechnology

Most recently a report from the National Research Council (www.nas.edu) has recommended changes to the policy by stating "Even given the strengths of the U.S. system governing transgenic plants, regulatory agencies should do a better job of coordinating their work and expanding public access to the process as the volume and mix of these types of plants on the market increase. "

2) Criteria to assess novel proteins' allergenicity

The cited criteria (available at http://vm.cfsan.fda.gov/~lrd/bioallrg.html) are not the result of extensive studies by EPA, but the opinions of scientists present at a 1994 Conference. They stated:

"There are no direct methods to assess potential allergenicity of proteins from sources that are not known to produce food allergy. Although, some assurance can be provided to minimize the possibility that a new protein will cause an allergic reaction by evaluating its similarity with characteristics of known food allergens (i.e. whether the new protein has a similar protein sequence, is resistance to enzymatic and acid degradation, is heat stable, and is of the appropriate molecular size), no one factor is predictive."

3) Of safety and risks

We enter here a moral, political and historical field. The concept of safety is highly dependent on the situation a person or a society is in. The legal standard for food in the US is prescribed by the FQPA-and it is "reasonable certainty of no harm". You have to be certain of no harm, not that we do not know. One can agree or not with this principle, but it is the one chosen by the US. So, uncertainty is not an argument for approval.

4) Risks and developing countries

I would like to clarify this issue. As stated above, I believe that the acceptable level of risk is a societal and political decision. Some countries (eg, Italy) have banned nuclear power because they felt it was dangerous; some others did not. I read China believes that Western countries are too cautious about GE foods, and that they do need them and cannot wait. Allergy is far more prevalent in Western countries, etc..

My question is: should regulators from any country take decisions based on cost/benefit analysis or on safety grounds only?

Luca Bucchini, PhD
School of Public Health
Johns Hopkins University, USA
lbucchin@jhsph.edu

-----Original Message-----
From: Biotech-Mod1
Sent: Wednesday, April 19, 2000 10:13 AM
To: 'biotech-room1@mailserv.fao.org'
Subject: Re: Bt, risks and developing countries

[Thanks to Professor Felsot and other recent contributors for their comments (and web links) regarding allergenicity and BT toxins. There is however a certain danger of drifting too far away from the theme of the conference (i.e. how appropriate are currently available biotechnologies in the crop sector for food production and agriculture in developing countries), so future contributors should keep this point in mind....Moderator]

Regarding the concerns about allergenicity, I would direct your attention to the following article that appeared recently and can be downloaded as a PDF file from the WEB at http://www.cgiar.org/biotech/rep0100/contents.htm Lehrer, S. 2000. Potential health risks of genetically modified organisms: how can allergens be assessed and minimized? Pp. 149-155 in "Agricultural Biotechnology and the Poor", G. J. Persley and M. M. Lantin, ed. Consultative Group on International Agricultural Research, the World Bank, Washington, D. C.

This article explains the strategy currently in use for testing for allergens. Besides digestibility rate in simulated gastric environment, DNA base homologies are also relevant and useful. Much is already known about allergenic food proteins, and the databases are used to guide testing for allergenicity.

With regard to the Bernstein et al. article (Environ. Health Perspectives 107:575-582) [see Edo Lin's comments, 18 April...Moderator], you may want to be aware that the immune reactions were specifically to a Bt spray product called Javelin. Javelin is a certified organic pesticide in the Pacific Northwest. The real story behind these immune reactions is more complicated than just mere positive reactions in the IgE antibody agglutination test and skin prick tests. The authors fractionated the Javelin preparation according to water soluble components (which could include exotoxins as well as cell fragments), vegetative cells (this is potentially a problem with whole cell preparations), spores, and delta-endotoxin. Pertinently, only the water soluble extracts, the vegetative cells, and spores gave a positive IgE reaction and skin prick test. The test with delta-endotoxin (i.e., the full version of the Bt transgenic endotoxin protein) was essentially negative, prompting the authors of the study to conclude "results of this investigation should partially allay recent concerns about the occurrence of possible adverse health effects in consumers after exposure to transgenic foods." Furthermore, "it is unlikely that consumers would develop allergic sensitivity after oral exposure to transgenic foods (e.g., tomatoes, potatoes) that currently contain the gene encoding this protein." You may also be interested to know that the test population for this study were vegetable pickers in Ohio, where multiple sprays of Javelin were used during the growing season.

It's amazing what gems the literature holds if we are willing to read it thoroughly with a critical eye. If you are interested in an elaboration of human health aspects as well as a look at natural Bt ecology and its evolution into a transgenic technology, I direct your attention to our newsletter, Agrichemical & Environmental News (http://www2.tricity.wsu.edu/aenews). See the March and April issues. A third essay on nontarget organism ecological effects will be on the WEB in another week.

Allan Felsot
Professor & Extension Specialist
Entomology/Environmental Toxicology
Washington State University
2710 University Drive
Richland, WA 99352, USA
Voice: 509-372-7365
Fax: 509-372-7460
afelsot@tricity.wsu.edu

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