[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 Forum website.
Note, participants are assumed to be speaking on their own behalf, unless they state otherwise.]

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 10:27
To: 'biotech-room1@mailserv.fao.org'
Subject: 59: Methodology for risk assessment

This is Bill Muir, Professor of Genetics. I conduct research on biotechnology risk assessment in aquaculture, produce transgenic fish, and examine impacts of transgenes on fitness components.

I totally agree with Professor Blanchfield's comments (Message 58, May 19). Because there are risks related to a technology, that does not mean we should abandon the technology until everything that is knowable is known, both of which are impossible. Rather there is an entire field of science devoted to methodology for risk assessment. The first fact is that there is no such thing as a zero risk of anything. Thus all risks must be put in terms of probabilities, such as there is an 80% chance of rain today (if rain were to be considered a hazard). Secondly, those risks must be weighed against, not only possible benefits, but also the alternatives, i.e. what is the cost in suffering etc. if we don't use this technology, or use a different technology. Finally, there are a number of ways to estimate risks of potential hazards in a safe secure setting such that a reasonable degree of safety can be determined before the technology is loosed on the world. This is how all new products, including pharmaceuticals, airplanes, cars, baby toys, etc. are evaluated before they hit the market. Biotechnology is no different.

Bill Muir, Ph.D.
Professor of Genetics
Department of Animal Sciences
Lilly Hall
915 W. State Street
Purdue University
W. Lafayette IN 47907-2054
United States
http://icdweb.cc.purdue.edu/~bmuir/
bmuir (at) purdue.edu

[Note, regarding risk assessment methodology, in Conference 7 of this Forum, held 31 May to 5 July 2002 and entitled "Gene flow from GM to non-GM populations in the crop, forestry, animal and fishery sectors", the main topic of discussion was the real or potential ecological impacts of gene flow and, in addition, how a science-based ecological risk assessment framework might be applied to gene flow. See the Summary Document from the conference...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 10:39
To: 'biotech-room1@mailserv.fao.org'
Subject: 60: Public understanding of biosafety issues in crops

This is from Danladi Dada Kuta, Nigeria.

Though the Federal Government of Nigeria has recently put in place the necessary policies and agencies for the advancement of biotechnology in the country, our recent independent survey shows that there is still low public awareness of issues concerning GE crops.

Many do not know the relevance of GE crops to Nigerian agriculture. Some are not sure whether GE crops will improve or degrade the environment. Several others doubt the ability of our scientists to predict the environmental impact of GE crops. Even among the national scientists/academicians, only few understand the issues concerning biosafety regulations of GE crops.

Those of us with good proposals on "educating the public about GE crops and its importance for Nigerian agriculture" are forced to shelf such proposals due to the lack of funds.

I think it is very important to take the public, especially the farmers, along in decision making concerning GE crops. With proper education, I believe the Nigerian farmers could be the ones demanding for the introduction of GE crops in Nigeria, and not just the agbiotech companies or scientists.

Danladi Dada Kuta,
Plant biotechnologist,
National Cereals Research Institute, Badeggi,
PMB 8 Bida,
Nigeria
drkuta2002 (at) yahoo.com

[The point made in the last paragraph of this message, about the importance of public participation in the regulatory process, was also made by Kelebohile Lekoape (Message 23, May 6). She argued that the most important lesson to be learnt from the experiences of countries that had already established GMO regulatory frameworks was "engaging the public at all levels, from drawing up a research policy to decision making of approvals. This bottom-up approach means consumers are not only a part of the process, they identify with it and assume responsibility for the end result, thus endorsing the credibility of a regulatory framework"...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 11:47
To: 'biotech-room1@mailserv.fao.org'
Subject: 61: Re: Methodology for risk assessment

This is from Julie Newman, Australia.

Regarding Bill Muir's comments (Message 59, May 20) on risk, I certainly agree with his final comment: "Finally, there are a number of ways to estimate risks of potential hazards in a safe secure setting such that a reasonable degree of safety can be determined before the technology is loosed on the world. This is how all new products, including pharmaceuticals, airplanes, cars, baby toys, etc. are evaluated before they hit the market. Biotechnology is no different."

Unfortunately, the risk management for transgenic products has assumed a management of it's own. It is unbelievable that in this day and age, our governments are allowing companies to form their own committees in the guise of misleading governments into thinking that risk is to be managed.

The current management plans imposed by the Australian government is to place unacceptable cost and liability onto those farmers not wanting to use the product for controlling uncontrollable contamination. Would we ever see this sort of imposition imposed on any other industry? Imagine releasing a pharmaceutical, airplane, car or baby toy that was known to have faults but accepting plans prepared by their manufacturers that the cost and liability for managing their problem is on anyone else except those that use or produce the product. For example, a car released without brakes and a management plan would have strict management codes for all concerned to avoid that sort of car and to accept liability if an accident did occur. I think not!

When formulating any legislation and management proposal, do not try to deal with the agricultural industry any differently than you would deal with any other industry. The GM product provider must be legally responsible for containing and controlling their product and for any economic damage that would occur.

Julie Newman
P.O. Box 6
Newdegate, 6355
West Australia
Ph (08) 98711562
www.non-gm-farmers.com
newseeds (at) treko.net.au

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 12:00
To: 'biotech-room1@mailserv.fao.org'
Subject: 62: Re: Methodology for risk assessment

This is from Reinald Doebel, Germany

My concern for this whole discussion comes from my initial training as an agricultural engineer and the experiences with the notion of "development" in Malaysia, Zambia, and India. My comment concerns Prof. Muir's exposition of the technology of risk assessment (Message 59, May 20).

I commend Prof. Muir for explaining so clearly the requirement for a proper risk assessment: risk assessment is done on the basis of the likelihood (probability) of a certain outcome to happen. One must know whether the likelihood for obtaining a certain benefit is 1 percent, 10 percent or whatever. And equally, one must know whether the likelihood for a certain accident to occur is 1 percent, 10 per cent, or 65 percent. It is on this basis that not only risk assessment in the area of technology development is handled, but also the whole insurance business. In the insurance business this is developed to the fine art of being able to adjust the fees for car insurance to the type of the car, based on statistics about the frequency of accidents with that car type.

I mention the example of insurance companies to illustrate the basic requirement for proper risk assessment: the probability for the occurrence of a "risk" must be known. And it can be known only on the basis of what has really happened in the past. Everybody knew about the theoretical possibility that a nuclear accident can happen, but on the basis of probability, nobody predicted Chernobyl.

I do not mention Chernobyl to "subliminally" suggest that genetic engineering is even remotely as dangerous to living organisms as the technology of the fission of atoms. I mention it because of the similarity of these two technologies precisely with respect to statistics: to the extent that a technology is really new, there are no precedences on the basis of which the probabilities demanded by Prof. Muir for a proper risk assessment can be established. The conclusion is: if we know little about possible dangers, we are not in a position to establish possibilities - and hence simply cannot conduct proper risk assessment. Risk assessment with respect to car technologies, airplane technologies etc. is based on hundreds and thousands of cases of real experiences with similar items. There is no similar item to a gene into which an "alien" piece of DNA has been inserted in a place where it does not belong. There is no real similarity between genetic engineering and breeding: "breeding" leaves the chemical processes of adding a new piece of information to the interaction between the organism and the environment. Genetic engineering attempts to insert "information" without consideration of either the intra-molecular interaction (which is known to exist) between different parts of the DNA molecule, and also without consideration of the interaction between the environment and the information present in the chromosomes. Thus, there is no precedent for properly (i.e. "scientifically") assessing the risks connected with that technology - by the very standards which Prof. Muir has so clearly laid out.

I would appreciate if any of the participants of this conference could point out a flaw in the above argumentation - because if there is no flaw in it, then it turns that caution (taking into consideration some known dangers which have been mentioned) is the more appropriate attitude to regulation. Rather than the emotional appeal to the possible benefits and the equally emotional threat that we might fall back into the stone age if we did not explore this technology.

Dr. Reinald Doebel
Institut fuer Soziologie
Scharnhorststr. 121
48151 Muenster
Germany
dobel (at) uni-muenster.de

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 13:51
To: 'biotech-room1@mailserv.fao.org'
Subject: 63: Re: Methodology for risk assessment

This is Prof J Ralph Blanchfield again, responding to Dr Doebel (Message 62, May 20) who asks for the flaw in his argumentation.

A major flaw lies in his statement:' "breeding" leaves the chemical processes of adding a new piece of information to the interaction between the organism and the environment.' Instead of inserting specific known genes in a targeted way, "breeding" inserts an unknown collection of genes in an untargetted way. Whatever the problems of genetic modification, they are at least matched if not surpassed by those of "breeding". It is also overlooked that so-called "conventional" breeding has included polyploidisation and treatment with irradiation.

Dr Doebel refers to vast experience on which to base risk assessment in airplane technology. None of that experience existed at the time of the first Kitty Hawk flight of the Wright brothers in 1903. Without progressing from there in the face of the unknown we would not have today's intercontinental passenger and cargo flights. By the same token, we cannot expect today's early GM to deliver all the foreseeable potential benefits, but we need to be able to build on today's early GM technology.

The purpose of risk assessment does not end with carrying it out. We (society and scientists as part of society) are not disinterested bystanders merely trying try to assess problems. We should be doing so in order to address and solve those problems, so that the potential benefits that future GM can offer may contribute to help feeding the world's escalating population, especially in the poorest developing countries where most of that growth is expected to occur. If some dismiss that as "emotional appeal", I call it a scientific and social responsibility. [Conference 5 of this Forum, entitled "Can agricultural biotechnology help to reduce hunger and increase food security in developing countries?" (held from 1 November to 17 December 2000), discussed in detail the potential impacts of biotechnology (including GMOs) on hunger. Further messages on the subject will not be posted here...Moderator].

Prof J Ralph Blanchfield, MBE
Food Science, Food Technology and Food Law Consultant
Chair, External Affairs, Institute of Food Science and Technology
Webmaster / Web Editor, Institute of Food Science and Technology
Vice President, European Food Law Association of the UK
Immediate Past Chair, IFT Committee for Global Interests
Adjunct Professor, Michigan State University
IFST Web address www.ifst.org
Personal Web address www.jralphb.co.uk
jralphb (at) easynet.co.uk

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 16:35
To: 'biotech-room1@mailserv.fao.org'
Subject: 64: Codex - Draft Food Safety Assessment Guideline

This is Héctor Villaverde, from Chile.

My apologizes for the big quotation, but this is what consumers wish to keep contained by regulations, not more and more marketing campaigns and rhetorics about benefits of biotechnology. The quotation is not extracted from a "luddite" pamphlet, but from Appendix III on the "Draft Guideline for the Conduct of Food Safety Assessment of Food derived from Recombinant-DNA Plants" in the Codex Alimentarius' report Alinorm 03/34. The following sentences are real risk assessment:

"UNINTENDED EFFECTS

14. In achieving the objective of conferring a specific target trait (intended effect) to a plant by the insertion of defined DNA sequences, additional traits could, in some cases, be acquired or existing traits could be lost or modified (unintended effects). The potential occurrence of unintended effects is not restricted to the use of in vitro nucleic acid techniques. Rather, it is an inherent and general phenomenon that can also occur in conventional breeding. Unintended effects may be deleterious, beneficial, or neutral with respect to the health of the plant or the safety of foods derived from the plant. Unintended effects in recombinant-DNA plants may also arise through the insertion of DNA sequences and/or they may arise through subsequent conventional breeding of the recombinant-DNA plant. Safety assessment should include data and information to reduce the possibility that a food derived from a recombinant-DNA plant would have an unexpected, adverse effect on human health.

15. Unintended effects can result from the random insertion of DNA sequences into the plant genome which may cause disruption or silencing of existing genes, activation of silent genes, or modifications in the expression of existing genes. Unintended effects may also result in the formation of new or changed patterns of metabolites. For example, the expression of enzymes at high levels may give rise to secondary biochemical effects or changes in the regulation of metabolic pathways and/or altered levels of metabolites.

16. Unintended effects due to genetic modification may be subdivided into two groups: those that are "predictable" and those that are "unexpected". Many unintended effects are largely predictable based on knowledge of the inserted trait and its metabolic connections or of the site of insertion. Due to the expanding information on plant genome and the increased specificity in terms of genetic materials introduced through recombinant-DNA techniques compared with other forms of plant breeding, it may become easier to predict unintended effects of a particular modification. Molecular biological and biochemical techniques can also be used to analyse potential changes at the level of gene transcription and message translation that could lead to unintended effects.

17. The safety assessment of foods derived from recombinant-DNA plants involves methods to identify and detect such unintended effects and procedures to evaluate their biological relevance and potential impact on food safety. A variety of data and information are necessary to assess unintended effects because no individual test can detect all possible unintended effects or identify, with certainty, those relevant to human health. These data and information, when considered in total, provide assurance that the food is unlikely to have an adverse effect on human health. The assessment for unintended effects takes into account the agronomic/phenotypic characteristics of the plant that are typically observed by breeders in selecting new varieties for commercialization. These observations by breeders provide a first screen for plants that exhibit unintended traits. New varieties that pass this screen are subjected to safety assessment as described in Sections 4 and 5."

Héctor Villaverde
Food Programme Co-ordinator
Consumers International
Office for Latin America and the Caribbean
Las Hortensias 2371
Providencia, Santiago
CHILE
Phone: (56-2) 335-1695
Fax: (56-2) 231-0773
Email: programalimentario (at) consint.cl
www.consumidoresint.cl

[The quotation above is taken directly from paragraphs 14-17 of Section 3 (Introduction to Food Safety Assessment) of the "Draft Guideline for the Conduct of Food Safety Assessment of Food derived from Recombinant-DNA Plants" presented in pages 47-56 of report ALINORM 03/34, which is available towards the bottom of page http://www.codexalimentarius.net/reports.asp in English, French and Spanish. As explained at the bottom of Message 25 (May 7), the Joint FAO/WHO Codex Alimentarius Commission is an intergovernmental body set up to establish international standards on foods. The Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology agreed, at its 3rd session held on 4-8 March 2002 in Yokohama Japan, to advance the following texts to the 26th Session of the Codex Alimentarius Commission (to be held 30 June - 7 July 2003, Rome, Italy) for adoption:
1) The Draft Principles for the Risk Analysis of Foods derived from Modern Biotechnology
2) The Draft Guideline for the Conduct of Food Safety Assessment of Foods derived from Recombinant-DNA Plants
3) Proposed Draft Annex on the Assessment of Possible Allegenicity (an Annex of 2)).

ALINORM 03/34 is the report of this 3rd session. Reading from the Scope of the Draft Guideline, among other things it says that "This Guideline supports the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. It addresses safety and nutritional aspects of foods consisting of, or derived from, plants that have a history of safe use as sources of food, and that have been modified by modern biotechnology to exhibit new or altered expression of traits. This document does not address animal feed or animals fed with the feed. This document also does not address environmental risks". and "The Guideline describes the recommended approach to making safety assessments of foods derived from recombinant-DNA plants where a conventional counterpart exists, and identifies the data and information that are generally applicable to making such assessments"...Moderator].

-----Original Message-----
From: Biotech-Mod1
Sent: 20 May 2003 17:21
To: 'biotech-room1@mailserv.fao.org'
Subject: 65: Regulation of GM versus conventionally bred plants

This is Professor Muir again. So sorry to get the list off on a divergent track already covered in Conference 7 of this Forum. However, in many aspects the regulatory framework and methodology for risk assessment cannot be separated. In the Background Document to this current conference, it states that "Regulation of GMOs has therefore always been a central part of the general GMO debate i.e. what kind of regulations they should be, what exactly they should regulate, how strict they should be, how GMOs should be regulated compared to their conventionally-bred counterparts etc.." .

The answer to the question posed was addressed by the National Academy of Sciences "Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation (2002)" viewed at http://books.nap.edu/books/0309082633/html/index.html [This publication by the Committee on Environmental Impacts Associated with Commercialization of Transgenic Plants stems from the request by the United States Department of Agriculture (USDA) to the National Academy of Sciences to examine the scientific basis for and the operation of APHIS (Animal and Plant Health Inspection Service of the USDA) regulatory oversight...Moderator].

One of their main conclusions was that regulatory review should be the same for conventionally bred plants as for Genetically Modified (GM) plants. The basis for that conclusion was that specific traits introduced by both process can pose unique risks. In essence, they are saying the regulatory process is adequate for GM plants but inadequate for plants altered using conventional breeding techniques. It should be noted that one of the commonly used techniques in conventional breeding is mutagenesis induced using ionizing radiation.

While I believe that the range of traits that can be induced by transgenesis is much greater than that with mutagenesis, because mutagenesis is only inducing point mutations while transgenes are moving entire intact genes between species, I tend to agree with the basis logic of regulating the product not the process. In that regard, it is possible to evaluate risk of both types of plants (GM and Conventional) using the same methodology and that the regulatory framework could be the same. What that methodology is was the object of the Conference 7 of the Forum.

Bill Muir, Ph.D.
Professor of Genetics
Department of Animal Sciences
Lilly Hall
915 W. State Street
Purdue University
W. Lafayette IN 47907-2054
United States
http://icdweb.cc.purdue.edu/~bmuir/
bmuir (at) purdue.edu

[Professor Muir is correct about the difficulty of separating discussions of risk assessment and management from those of regulatory frameworks. In the Background Document to Conference 9, indeed, one of the questions we had asked people to discuss was
"- When addressing risk analysis and risk management in the regulatory framework, should
a) the risks associated with GMOs be compared with those from their conventionally-bred counterparts?
b) economic, social and ethical factors be included, in addition to potential human health and environmental impacts?"
Obviously, however, we don't want to go through exactly the same arguments as in Conference 7...Moderator].