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Date:

October 6, 2001

Subject:

Pharm Proteins; CIMMYT Responds; S. Africa Policy;

 

Today's Topics in AgBioView.

* Discussion on Pharmaceutical Crops and Green Opposition
* CIMMYT Response to Transgenic Maize Growing In Mexico
* South Africa: Draft Policy For GM Foods
* The Politics of Precaution: GM Crops in Developing Countries
* Seeds of Contention: World Hunger and the Global Controversy Over GM Crops
* Largest U.S. Summit of African Leaders in US
* Six PNAS Papers on Monarch - Bt Now Published
* U.S. and the Precautionary Principle: An NGO Response /Cartagena Protocol
* Transatlantic Regulatory Regionalism: The Case of Ag Biotech
* Labeling of Foods From Modern Biotechnology


From: Bob MacGregor
Subject: Re: Pharmaceutical plants

As crop genetic engineering moves beyond food crops into pharmaceuticals, fuels, industrial chemicals, and phytoremediation, it will become increasingly important to keep medical and industrial varieties separate from food varieties (both in product and genetics).

For a while, protocols like those to keep industrial rapeseed and canola separate might also work to assure separation of industrial/medical crops, however, as these specialty crops proliferate, separation will become increasingly difficult. Accordingly, I envision two principle approaches to assure that undesirable crop mixing or cross pollination will not be likely.

First, the desired trait should be linked with other characteristics that (1) make the specialty crop visually distinguishable from other (eg, food or feed) varieties of the crop, and (2) make chemical identification/detect ion quick, easy and inexpensive. These steps are designed to help with identity preservation/segregation in the product stream.

Second, these special crops would be ideal candidates for use of sterility traits (eg "terminator") or plastid transformations (eg chloroplasts) to assure that (1) the genes don't spread to food or feed varieties of the crop (or wild relatives) via pollen dispersal, and (2) owner can keep control of these valuable traits more easily (avoid the Schmeiser scenario).

In the case of medical molecules, it will frequently be possible to raise crops in substantial isolation-- in some cases, even entirely in greenhouse s. However, this is not the case for many industrial crops for fuel or chemical feedstocks, where much greater acreage would be needed. In either case, placing fully fertile GE varieties in close proximity to food varieties, particularly when the seeds are visually indistinguishable, would be asking for another Starlink fiasco. I think protocols need to be established to take care of both issues: fertility (gene escape or "contamination") and inadvertent mixing of industrial and conventional food varieties after harvest.

We need to keep in mind Murphy's law and think of as many contingencies as possible-- particularly in light of the Starlink setback and the tack of anti-GE rhetoric to date; address the issues in policy (to the degree possible) so some screw-up won't completely scuttle progress of the technology. Finally, in recognition that government foresight sometimes falls a bit short of perfection, we will, obviously, be forced to walk a line between covering all the contingencies and allowing the industry enough room to progress. Too much regulation does little to add to public safety (and often seems not even to add to a perception of greater safety!), and certainly discourages development of new products and processes. The trick will be to find the minimal level of government regulatory oversight that still maintains an acceptable level of public and environmental safety. Sorry to say that there will never be consensus on this, since a lot of folks seem to be demanding 100% assurance of safety!

- BOB
+++++++++++

From: Willy DE GREEF
Subject: Protein Therapy Could Heal Agbio: a reaction

Dear AgBioWorld,

I would like to react to the expectation of easier acceptance of therapeutic proteins in plant biotechnology expressed in your 4th October issue (Red Herring article). It will only happen if we work on it, hard.

Reality-check:
A. This year early field trials with therapeutic proteins have been targeted by protest groups in the USA and France, leading for the French trial to destruction of the plant material. The US trial (rice expressing a therapeutic protein) was targeted by Greenpeace.

B. The "ultimate-politically-correct" application of ag-biotech, Golden Rice, was attacked viciously despite being targeted at a massive public health problem of the poor in the developing world, and despite being developed by a consortium of public research institutions.

Farming molecules for health care is a fantastic new opportunity to combine our knowledge of agriculture and biotechnology in an entirely new field of applications. For us in the technology development community it is self-evident that it is a great way of doing things, with benefits for the patients who will benefit from the products, for the specialised farmers who will grow the crops for us, and for the companies that develop the technology and the products. But the same was true for the agricultural applications. In fact, ag-applications are further along. Many contributions to this newsletter attest to the fact that many of the promises made about ag-biotech 10 years ago have been delivered upon, and they would have done even better without the havoc created by the protest industry.

To the extent that health care applications of GM crops are developed by industry and by what is seen by the anti-biotech lobby as its ally big science, it risks becoming an increasingly attractive target for the organised protest groups. It just fits too well in their concept of corporate interests ruling public interests, such as food security and public health. Never mind that most of the companies involved today are not big pharma or ag-biotech multinationals.

The easy way to deal with the difficult lessons of the past decade is to consider them irrelevant for the new field. That is wishful thinking. Some like to point to the generally more positive attitude expressed in opinion polls for medical applications for biotech. But ag-food applications had even better results in those same polls ten years ago! It is important that the many public research institutions and companies involved in the development of GM plants for the production of therapeutic molecules remain fully aware of the risk of becoming the next favorite target for the fear-and-protest industry. Only then will we all focus on the pro-active dialogue with society that will avoid a repetition of the situation we have lived through in the ag-biotech world.

The right place to do that is at the grassroots level, in the educational community, in the medical community, and with the general public. We still have a window of opportunity to provide these groups with a comprehensive view of what we are doing and why, how it will benefit them, and how we will make it safe. Such work requires time. It takes time to reach these constituencies, and it takes time during each individual encounter to sit down with an audience and listen to their questions and concerns, explain and inform. The time to do that is not when the products are almost ready. It is now. Greenpeace is already "test-marketing" the potential of medical applications of ag-biotech for its constituencies. Once they move into production-line campaigning, it will become very difficult to get information heard through the barrage of one-liners. That is another lesson we have learned the hard way.

- Willy De Greef, Head Regulatory Affairs, Syngenta Seeds

+++++++++++++++++++++++++++++++++++++++

CIMMYT Response to Discovery of Transgenic Maize Growing In Mexico

El Batan, Texcoco, Mexico, October 4, 2001-

Technical and political issues surrounding transgenic maize ran headlong into environmental and cultural concerns when an article in the September 27, 2001 issue of Nature (Vol 413) reported that transgenic corn had been found growing in the Mexican states of Oaxaca and Puebla. This followed on the heels of similar reports in the local media.

The International Maize and Wheat Improvement Center (CIMMYT), headquartered in Texcoco, Mexico, regards this as a serious development and offers its considerable expertise to the appropriate Mexican institutions to (1) help identify the type and source of the introduced gene(s), (2) assess potential impacts to biodiversity, the ecology, and the socioeconomic environment, and (3) to explore possible responses.

Recognizing the importance of Mexico's role as a center of origin and domestication of maize, CIMMYT has devoted significant resources to helping conserve the genetic diversity of the nation's maize landraces. It has done this through its gene bank, which maintains one of the world's most extensive collections of maize varieties, landraces, and wild relatives, and by working to maintain diversity in natural settings.

Since 1997, CIMMYT has worked directly with farmers in Oaxaca and elsewhere in Mexico, training them and refining management practices that allow them to increase their productivity, while at the same time preserving or enhancing genetic diversity at the farm and community levels. Research has also been undertaken to examine the flow of maize genes amongst farmers and communities and the impact these flows have on the genetic diversity of maize and its wild relatives (teosinte and Tripsacum). This work, which did not involve transgenic germplasm, can be extended to ascertain the potential impact of introducing genetically modified maize into traditional farming systems. Such introductions are likely to have little, if any, effect on the genetic diversity of either maize landraces or wild relatives. Rigorous studies are needed in this area, however, as well as on the possible effects on the environment, and potential economic impacts.

In its own transgenic work with maize, CIMMYT has strictly adhered to the Mexican biosafety regulations and protocols. CIMMYT's last on-station field trial of transgenic maize concluded in September 1999, at the Tlaltizapán Experiment Station, in the state of Morelos. Although the Mexican authorities announced a de facto moratorium in 1998, this applied primarily to scaling-up research to commercial levels and to applications for new research. In January 1999, the Directorate of Plant Health, a branch of the Ministry of Agriculture, approved the application for this final on-station trial, to enable CIMMYT to complete the final component of a series of experiments.

A delegate from the Directorate of Plant Health closely monitored the implementation of the research plan and trials. A minimum of 200 meters of barrier plantings was maintained between the transgenic experimental plot and other conventional trial plots. All tassels were removed from the transgenic plants to keep them from pollinating other plants. In addition, planting times for the transgenic maize, the barrier maize, and other maize plots were staggered to further preclude inadvertent pollination. Harvesting was strictly controlled and all transgenic kernels (seed) were securely transported to CIMMYT headquarters. All vegetative transgenic plant material and all barrier plants were incinerated. The experimental plots were plowed, tilled, and monitored for the emergence of any maize plants, which were immediately destroyed.

Today, CIMMYT continues research on transgenic maize within the confines of its biotechnology laboratories and its Level 3 Biosafety Greenhouses (as designated by the U.S. National Institute of Health; Level 1 being the lowest level of biocontainment and Level 4 the highest). Absolutely no CIMMYT transgenic maize is grown outside of these secure facilities.

To date, details of the studies referred to in Nature (Vol. 413) about the discovery of transgenes in Mexican landraces have not been released to the public. CIMMYT looks forward to obtaining and reviewing the data and determining the implications both for Mexico and for CIMMYT's work. The Center is in a unique position to assist in such investigations, and, given our mandate to serve the resource poor of the developing world, to work on approaches to maize improvement that benefit poor farmers while protecting valuable genetic resources and the environment.

+++++++++++++++++++++++++++++++++++++++

South Africa: Draft Policy For GM Foods

- Africa News, October 5, 2001

The government has allocated R182-million to biotechnology research and development.After more than 20 years of debate and consultation, South Africa has come up with a draft policy on genetically modified (GM)food and products. Published a month ago, the draft-strategy document states that biotechnology will improve access to and affordability of health care, provide sufficient nutrition at affordable costs, create jobs in manufacturing, and protect and enrich the environment.

As early as 1978 a committee of scientists took the initiative to establish an organisation, known as South African Genetic Experimentation, which would act as a watchdog and advisory body to scientists, industry and the government. It developed a set of bio-safety guidelines that have been applied to all GM products and trials since 1990. The use of modern biotechnology includes commercial virus elimination and plant production through tissue culture of date palms, bananas, soy beans, dry beans and others. In animals it includes artificial insemination, embryo transfer, human organ transplant, in vitro fertilisation and embryo culture, and vaccine production for animal and human health.

Project manager of the South African National Seed Organisation Dr Wynand van der Walt says although South Africa has a solid history of engagement with traditional biotechnology, it has failed to extract value from more recent advances, particularly over the past 25 years with the emergence of genetics and genomic sciences.

He says the development of biotechnology should not be restricted to developed countries. "Developing countries such as Cuba, Brazil and China have been quick to identify potential benefits of the technology and have established measures to develop such industries and extract value where possible and relevant." South Africa was active in the development of the International Convention on Biological Diversity, and the Cartagena Bio-safety Protocol.

The draft strategy provides for the mandatory labelling of GM food and products, including specifications with regard to the composition, mode of storage, levels of allergens and toxins, and guidelines regarding human or animal genes.

The draft strategy has the support of the Department of Agriculture. Dr Shadrack Moephuli, the department's director of genetic resources, says the introduction of GM seed has the potential to generate employment. Other areas that stand to benefit include stock theft as new techniques for the identification of animals can be developed using biotechnology.

However, he raised a few concerns about the way in which the GM products would be monitored and regulated. "What remains contentious to me is to what extent poor people in rural areas, as well as consumers, would benefit from the whole process. We need a debate about pollution, cross-pollination, biotechnology, and invasive species."

Dr Chris Viljoen, senior lecturer at the University of the Free State's botany and genetics department, calls for a cautious approach in the regulation of GM foods and products. "Identity preservation, or the ability to distinguish GM varieties is a prerequisite to manage GM plant use in African agriculture. This would avoid a situation where farmers have to pay the patent holder its rightful royalty."

Viljoen says his department, in collaboration with overseas institutions, is using deoxyribo-nuclei acid technology to detect the presence of GM organisms in highly processed food constituents such as starches, oils and syrups. "The service was established to accommodate growing consumer discernment and to meet international export regulations."

Scientists often advocate that modern biotechnology can solve the world's food shortage problem. Viljoen disagrees: "In reality there isn't a food shortage in the world, rather there is a problem of food distribution. If the developing countries are unable to buy food from developed countries because it is too expensive, how will they able to buy GM seed? The government should be in the position to subsidise emerging farmers so that they can cope with the new biotechnology needs."

Viljoen says the danger lies in Africa becoming an unwilling dumping ground for consignments of rejected GM products. Jerry Sefoloshe, chairperson of the Letelle Farmers' Union in Groblersdal, Mpumalanga, says although biotechnology can play a role in modernising farming techniques, it should not be prescribed by Europe and North America.

The draft national strategy says South Africa should "assess our biotechnology programmes within the framework of the Constitution, which ensures our rights to safety, to choice and to information establish suitable regulatory systems for export-import trade in biotechnology products and to increase the level of public awareness and acceptance of these products".

The government is allocating R45-million as part of the overall strategy on biotechnology, and an additional R182-million on biotechnology research and development. There are about 600 biotechnology research projects in South Africa in the fields of agriculture, food, veterinary science, the environment and chemistry.

+++++++++++++++++++++++++++++++++++++++

The Politics of Precaution: Genetically Modified Crops in Developing Countries

- Robert L. Paarlberg

184 pages / 2001; $45.00 paperback / ISBN 0-8018-6668-5; $19.95 paperback / ISBN 0-8018-6823-8; Order this book: http://www.ifpri.cgiar.org/pubs/jhu/politicsprecaution.htm

"This is the first major empirical study that sheds light on the policy dynamics influencing the adoption of biotechnology in developing countries. The analytical framework and the wealth of new information make it both original and substantive. In addition, the study is an honest and candid account of trends in developing countries. This is an important book that will inspire the practitioner, challenge the academic, satisfy the curious, and appease the bewildered."
-- Calestous Juma, Harvard University

Genetically modified (GM) food crops have inspired increasing controversy over the past decade. By the mid-1990s they were widely grown in the U.S., Canada, and Argentina, but precautionary regulations continue to limit their use elsewhere. The restrictive policies of Europe and Japan toward GM crops have been much discussed. Less attention has been paid to the policies affecting the adoption of GM crops in the developing world, where their potential impact on the availability and quality of food is even greater.

In this book Robert Paarlberg looks at the policy choices regarding GM food made by four important developing countries: Kenya, Brazil, India, and China. Of these, so far only China has approved the planting of GM crops. Paarlberg identifies five policy areas in which governments of developing countries can either support or discourage GM crops: intellectual property rights, biosafety, trade, food safety, and public research and investment. He notes that highly cautious biosafety policies have so far been the key reason that Kenya, Brazil, and India have hesitated to plant GM crops. These cautious policies have been strongly reinforced by international market forces and international diplomatic and NGO pressures. China has been less cautious toward GM crops, in part because there is less opportunity in China for international organizations or independent critics of GM crops to challenge official policy.

=====

Seeds of Contention: World Hunger and the Global Controversy Over GM Crops

- Per Pinstrup-Andersen and Ebbe Schi¯ler

176 pages / October 2001; $12.95 paperback / ISBN 0-8018-6826-2
Order this book http://www.ifpri.cgiar.org/pubs/jhu/seedscontention.htm
ORDER or DOWNLOAD the Food Policy Statement 33
http://www.ifpri.cgiar.org/pubs/pubs.htm#fps

"A timely contribution on an important issue. It is great to have an unemotional, broad-based assessment of genetically modified crops."
-- Lester Brown, Worldwatch Institute

"This book presents a balanced perspective on the potential benefits and risks of modern biotechnology for developing-country food and agriculture and suggests action to reduce risks and increase benefits. It is an excellent and highly welcome addition to the ongoing debate on biotechnology and GM foods."
-- Gordon R. Conway, President, The Rockefeller Foundation

=======
Food Policy Statement No. 33
In recent years the media have reported, frequently with alarm, on the increasing use of genetically modified crops in agriculture. Some groups have expressed concern about consumer safety and the risks of large-scale ecosystem damage. Others have noted the resulting shift of power away from locally controlled farming operations toward large agribusiness and biotech companies, and the particular vulnerability of farmers in the developing world to this trend.

In Seeds of Contention: World Hunger and the Global Controversy over GM Crops, development specialists Per Pinstrup-Andersen and Ebbe Schi¯ler focus attention on the less discussed issues of the potential benefits and costs of genetically modified crops for developing countries. Pinstrup-Andersen and Schi¯ler review the basic issues and discuss the potential that such crops have for addressing the great needs of poor and undernourished peoples throughout the world. They explain how increased agricultural productivity is not enough in addressing the problem of famine. People in developing countries need crops that are disease-resistant, can fend off insect predators, and can withstand severe environmental conditions in order to produce larger crop yields.

Pinstrup-Andersen and Schi¯ler are sober in their assessment of these prospects, for they acknowledge that GM crops alone will not solve the world's food problem. They argue, however, that they may be one element in the solution and people in developing countries should have information about benefits and risks and the freedom to make their own decisions about whether or not to grow and consume GM crops.

+++++++++++++++++++++++++++++++++++++++

Largest U.S. Summit of African Leaders in US

http://www.africacncl.org/Summit/agenda.htm

WASHINGTON - The U.S.-Africa Business Summit has been rescheduled for October 30 - November 2. The Summit, organized by Corporate Council on Africa (CCA), will be the largest gathering of African government and business leaders ever to convene in the United States (outside of the United Nations). The Summit was originally scheduled to take place in Philadelphia on September 16-20.

Confirmed participants included 13 presidents, three prime ministers, the president of OPEC, and the U.S. Secretary of Commerce (scheduled to deliver a major address of the Administration's trade policy for Africa), as well as numerous officials from the multilateral to local levels. The roster of confirmed delegates includes over 1400 delegates, with representation from all 53 African nations.

Keynotes and workshops will focus on many topics including agribusiness and environment/sustainable development The Summit venue is the Loews Philadelphia Hotel. For more information, contact: (202) 835-1115; Tim McCoy (press only) ext. 29; fax (202) 835-1117.
----

D-1 Biotechnology
Moderator: Ambassador Andrew Young, Chairman GoodWorks International
Speakers:
Kinyua M'bijjewe, Director, African Government Affairs, Monsanto Company
H.E. Prof Turner Isoun*, Minister of Science & Technology, Federal Republic of Nigeria
Cyrus Ndirutu, former director Agriculture Research Institute, Kenya
T. J. Buthelezi, Chairman, Ubongwa Farmers Association, South Africa

+++++++++++++++++++++++++++++++++++++++

Six PNAS Papers on Monarch - Bt Now Published

Results of collaborative research by scientists from universities and research institutions in the United States and Canada, which examined the risks of Bt corn to monarch butterflies have been published in the Proceedings of the National Academy of Sciences (PNAS). These studies from leading scientific experts provide science-based evidence that potential risks of Bt corn to monarchs is low.

The papers are available on-line: http://www.pnas.org/papbyrecent.shtml

· Sensitivity of Monarch Larvae to Bt proteins and Pollen in Laboratory Conditions
· Levels of Corn Pollen on Milkweeds in and near Cornfields
· Exposure Level Assessments in Natural Monarch Breeding Habitats
· Impact of Bt Corn Pollen on Monarch Larvae in Field Conditions
· Effects of Event 176 Bt Corn Pollen on Monarch and Black Swallowtail Caterpillars Under Field Conditions
· Overall Risk Assessments on the Impact of Bt Corn Pollen to Monarchs

+++++++++++++++++++++++++++++++++++++++

The U.S. and the Precautionary Principle: An NGO Response in the Context of the Cartagena Protocol

http://www.sehn.org/bioessays.html

In this paper we outline four considerations that will help to focus implementation of the precautionary principle in the Cartagena Protocol. In the second part we offer responses to criticisms of the precautionary principle which are often presented by U.S. officials and others who support U.S. viewpoints. Such arguments have been raised in negotiations on the Protocol, as well as in recent international trade, environment, and food safety discussions. It is important to address these criticisms directly so they do not stand in the way of either a broad precautionary approach to protecting the environment and human health or specific precautionary actions taken to implement the Protocol.

+++++++++++++++++++++++++++++++++++++++

Transatlantic Regulatory Regionalism: The Case of Agricultural Biotechnology

- Dr. Grant Isaac (University of Saskatchewan) Agbiotech Bulletin Volume 9, Issue 8, October, 2001; Published by Ag-West Biotech Inc.

In November 1999, Canada and the United States jointly proposed the World Trade Organization as the international organization responsible for developing an internationally harmonized regulatory approach to biotechnology through the World Trade Biotechnology Initiative. The European Union (EU) completely rejected this proposal, preferring instead to develop an international regulatory approach congruent with the Cartagena Protocol on Biosafety. In this article, this transatlantic regulatory regionalism and its international consequences are examined in the context of the Biotechnology Regulatory Framework presented in the September 2001 AgBiotech Bulletin.

The first efforts to harmonize regulations dealing with modern biotechnology began in the mid-1970s. In February 1975 the US National Academy of Sciences convened the International Conference on Recombinant DNA (the ‘Asilomar Conference’), which brought together many of the world’s leading researchers to establish guidelines for dealing with the risks from the new technology. These guidelines were published in 1976 as the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules. The NIH Guidelines reflected a scientific rationality approach to regulating biotechnology where technological progress was a significant priority reflected in the subsequent principles. Perhaps the most important aspect of these guidelines was that they were product-based, not process-based.

The scientific Risk Analysis Framework (RAF) exemplified in the NIH Guidelines became the basis for not only the US regulatory approach, but also the regulatory approach supported by international organizations such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO), the Codex Alimentarius and the Organization for Economic Cooperation and Development (OECD). In fact, with respect to North America (NA) and the EU, both sides were on the same regulatory trajectory and the possibility of creating an international regulatory regime for GM foods based on the scientific rationality framework seemed very likely. Yet, by 1990 domestic factors resulted in a shift of EU regulation away from this common trajectory and towards the social rationality framework.

The current transatlantic situation remains one of regulatory divergence. Despite the fact that the RAF is used in both NA and the EU, the former’s scientific rationality approach conflicts with the latter’s social rationality approach. Transatlantic regulatory regionalism results as GM crops approved as safe in NA face significant regulatory delay – and in some cases denial – in the EU. To better illustrate this let’s compare the Canadian RAF regulatory approach to that of the EU, starting first with the General Regulatory Issues followed by the Specific Regulatory Issues (Figure 1). (Note: I have converted the three columns of the table to running text. Please match the numbers to read the table...CSP)

Risk Analysis Framework (RAF)

- General Regulatory Issues-
1. Belief
2. Type of risk
3. Substantial equivalence
4. Science or other factors in risk assessment
5. Burden of proof
6. Risk tolerance
7. Science or other factors in risk management
- Specific Regulatory Issues -
8. Precautionary principle
9. Focus
10. Structure
11. Participation
12. Mandatory labelling strategy
-------
"Scientific Rationality"

1. Technological progress
2. Recognized Hypothetical
3. Accepts S.E.
4. Safety , Health
5. Traditional: Innocent until proven guilty
6. Minimum risk
7. Safety- or hazard-based: Risk management is for risk reduction and prevention only.
--
8. Scientific interpretation
9. Product-based, novel applications
10. Vertical, existing structures
11. - narrow: ‘technical experts’ , - judicial decision-making
12. Safety- or Hazard-Based

-----------
"Social Rationality"

1. Technological precaution
2. Recognized Hypothetical and Speculative
3. Rejects S.E.
4. Safety, Health, Quality Socio-economic factors
5. Guilty until proven innocent
6. Zero risk
7. Broader socio-economic concerns: Risk management is for social responsiveness.
--
8. Social interpretation
9. Process- or technology-based
10. Horizontal, new structures
11. - wide: ‘social dimensions’ - consensual decision-making
12. Consumers’ ‘right to know’-based

(Figure 1: Regulatory Frameworks for Biotechnology Source: Isaac, G. (Forthcoming 2001) Agricultural Biotechnology and Transatlantic Trade: Regulatory Barriers to GM crops. CAB International Publishers: Oxon, UK.)

In Canada, regulatory inquiry is focused on scientific evidence of risk to health or safety such that new technology is considered innocent unless scientific evidence exists to prove it guilty. According to this approach, risk assessors are responsible for compiling objective and neutral risk information, which is then considered by the risk managers when determining market approval. The risk assessment information includes only scientific evidence of risk to health and safety and excludes risks to socio-economic factors. Essentially, science makes the regulatory decisions in the sense that it is the scientific information only that is considered by the risk managers. To ensure regulatory independence, the assessors are separated from the managers, but scientific rationality prevails over both. This implies that technological progress is the priority.

In the EU, science only informs the regulatory decision makers. The risk information provided by the risk assessors is only one part of the broader product information that is put before the risk managers. Other information includes potential risks to socio-economic factors. Unlike in Canada, the risk managers are usually elected politicians. The reason for this is to ensure regulatory accountability: as regulators exercise significant power in approving or denying new technologies, they must be accountable to the constituents exposed to any new risks. Hence, the regulatory separation is between the scientific risk assessment and the social risk management (political function), which aims to deal with all impacts of technological progress in a socially responsive, technologically precautious manner. To date no GM crop approved for commercial release in Canada has been rejected by the risk assessors in the EU, however, in some cases the regulatory approval has been delayed or rejected by the political risk m

These differences with respect to the General Regulatory Issues dealing with how to use science in public policy, result in significant differences in how to specifically regulate GM foods. While regulators in both Canada and EU employ the precautionary principle (which essentially means that in the absence of evidence of risk, product approval must not proceed), it is used differently. Canada employs the scientific interpretation of the precautionary principle; precaution is exercised when the absence of scientific evidence prevents an acceptable risk assessment. Contrast this to the EU’s social interpretation of the precautionary principle; precaution is exercised when the absence of socio-economic evidence prevents an acceptable assessment of the broader, non-scientific impacts of the technology.

The Canadian regulatory approach is product-based such that novelty is what triggers regulatory oversight for products derived from biotechnology, not the use of biotechnology per se. Due to this product-based focus, regulatory authority is given to the vertical agencies traditionally responsible for the products in question. The fact that both the risk assessors and the risk managers are scientists in the Canadian system results in a regulatory decision-making procedure that is narrow (mostly scientists are involved) and judicial (consensus among the risk managers is not mandatory). Finally, a mandatory labelling strategy is justified under two conditions: (1) scientific evidence of a health or safety risk to certain groups in the general population; and (2) if the product under consideration is deemed novel. The Canadian approach is generally well-regarded by scientific and commercial interests, but is perhaps vulnerable to criticism about its social responsiveness. Indeed, in response to such criticisms

In contrast to the Canadian regulatory approach, the EU approach is process- or technology-based such that the use of biotechnology techniques triggers regulatory oversight, not the novelty of the resultant product. A process-based regulatory focus results in a horizontal regulatory structure because the techniques of modern biotechnology may be the same regardless of the intended end-use of resulting products. Regulatory authority must be capable of working horizontally across the various applications. Further, the focus on science and non-science factors in regulatory approval requires a decision-making procedure that is both wide (to be socially responsive) and consensual (to maximize regulatory accountability). Finally, the process-based regulatory focus implies a mandatory labelling strategy justified by the consumers’ right to know about the presence of biotechnology in their foods. In shifting from a scientific to a social rationality framework, the EU tried to be everything to everyone. It seems, ho

This transatlantic regulatory regionalism is a stumbling stone – not a building block – to the establishment of an international regulatory approach to biotechnology. As long as these differences in the use of the Risk Analysis Framework remain, the scientific rationality approach adopted in Canada and the United States and supported by the World Trade Organization will conflict with the social rationality approach adopted in the European Union and supported by the Cartagena Protocol on Biosafety.
---
Grant Isaac is a faculty member of the College of Commerce and the Virtual College of Biotechnology at the University of Saskatchewan. His book, Agricultural Biotechnology and Transatlantic Trade: Regulatory Barriers to GM Crops, will be released in December 2001.

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Labeling of Foods From Modern Biotechnology

- Peter McCann, Agbiotech Bulletin Vol 9, Issue 8, October, 2001

Mr. Charles Caccia, MP, a member of the Canadian parliament, has introduced a Private Member’s Bill to mandate labeling of all foods or food ingredients that contain more than 1% of genetically modified material. This Bill conflicts with current Canadian policy on labeling, and goes against the recommendations of two expert committees, the Royal Society Expert Committee and the Canadian Biotechnology Advisory Committee, that the government asked to provide advice on the issue. It ignores the fact that Canada already has mandatory labeling for foods from biotech where there has been material change in composition of the food or in its nutritional value, as well as safety concerns such as the presence of known allergens.

The Bill would also override the multi-stakeholder process that is underway, organized and led by the Canadian General Standards Board, that involves over sixty groups representing a broad base of Canadian civil society. The CGSB process has been going on for eighteen months and includes industry groups, agricultural producers, consumers, and federal and provincial governments. This committee is working hard, and in good faith, to develop a workable labeling standard that will provide consumers with clear, useful, and informative labels. In addition, an international labeling standard is still under development by the United Nations’ Food and Agriculture Organization (FAO) Codex Alimentarius Commission.

If carried by our Parliament, the Bill would have serious trade implications for Canada. For example, since the US, our largest trading partner, has no plans to label foods from biotechnology, the sale of many food products currently imported from US would be prohibited, unless specially labeled products were produced for the Canadian market. By the same token, Canadian products exported to other countries, particularly in Europe, would be severely handicapped. It should be noted that while some countries have put mandatory labeling laws in place, none have the necessary operational systems to enforce them.

Foods from biotechnology undergo rigorous government assessment for human health, animal health, and environmental safety before they are approved for release to the public. The standards of assessment are based on the highest level of science that we have available. Canada has the best regulatory system in the world for ensuring that all the foods we eat are the safest they can be. In the history of biotech foods, going back almost a decade, there has not been a single instance of human or animal health being negatively affected. Mandatory labeling should not be allowed to become a quick fix to a non-existent problem.
-
Peter McCann can be reached at: peter.mccann@agwest.sk.ca