A Review of the Agri-Food Presentations from the Biotechnology Industry Organisation (BIO) 2001 International Convention

More contentiously, and perhaps stretching credulity, he also asserted that GM technology can help protect endangered animal species in developing nations.  Using the example of the economic and political crisis in Indonesia during the late nineties, Nill recounted that large-scale attacks took place on jungle animals that were sought out as an alternative source of protein by the populace.

Addressing the communication of biotech issues, the ASA has spent in the region of US$5 million in explaining and defending the technology, and their insights seem to suggest that GM opponents are not convinced by glossy brochures.  Instead, Nill recommended building a logical train of thought through the use of simple photocopied (original) news reports.  Finally, on a note of interest to European food processors, and speaking with a good degree of authority, Nill thought it would be too difficult to continue to separate GM from conventional produce for export markets.

Rhona Applebaum (National Food Processors Association, US) chaired the session on improving the safety of existing foods through biotechnology. She strongly endorsed the use of biotech for the “environment, consumers and the world”.

Improving the Safety of Existing Foods through Biotechnology

In chairing this session, Rhona Applebaum (Executive Vice President, Scientific and Regulatory Affairs, National Food Processors Association) strongly endorsed the use of biotech for the “environment, consumers and the world”, and provided a brief review of the key challenges facing food producers.

Beginning with a talk centred on the serendipitous finding that Bt technology has reduced the mycotoxin (fumonisin) content of corn,  Pat Dowd (National Centre for Agricultural Utilisation Research, USDA) reviewed the phenomenon in the context of the vast array of plant toxins which are already present in the food chain. Natural poisons produced by plants represent about 99% of all toxins; while they are widespread in plants, in general they do not occur at levels that cause an acute toxicity problem, provided the food is properly prepared. Examples include cyanogenics (lima beans), furanocoumarins (celery), hydrazines (edible mushrooms), glycoalkaloids (potatoes), oxalates (rhubarb) and satirole (nanafras – responsible for natural root beer flavour).  Many such substances have a defensive role, and are produced when plants are damaged.  Equally interesting, and an aspect often overlooked by opponents of GM technology, conventional breeding for insect resistance has actually led to toxins reaching the market (for example, in the case of potatoes and glycoalkaloids).

Mycotoxins produced by fungal genera such as Aspergillus, Penicillium and Fusarium are among the most potent toxins known. They occur primarily in seeds and nuts of high oil content. From studies conducted mainly in the South Eastern US, a number of factors influencing the reduction in mycotoxins by Bt corn have been identified.  The  timing of insect damage is a critical issue: insects can greatly increase the levels of fumonisin (especially the European Corn Borer).  Of equal importance are the specific insect/fungal species, the particular Bt construct and tissue expression patterns, and the geographic  location, weather and planting date of the crop. 

The inadvertent introduction of allergens into GM food is arguably the priority issue for the agri-biotech industry, and the presentation of Robert Buchanan (Department of Plant Physiology, University of California at Berkeley) reviewed promising strategies for production of hypo-allergenic wheat and more accurate prediction/detection of allergenic potential. The thioredoxin protein plays a regulatory role in all types of cell, and is involved in seed germination in cereals. Thioredoxin reduction of small disulfide proteins results in a loss of biochemical activity, mitigation of allergenic potential and loss of heat-resistance. In effect, thioredoxin changes the shape of the protein allergen so that the immune system recognises it less well.  In the late nineties, Buchanan and collaborators demonstrated that thioredoxin could be applied in vitro to reduce the allergenic potential of beta-lactalglobulin in milk.  Similar results have been found in wheat, thereby holding out the possibility of aiding those suffering from coeliac disease through genetically modifying wheat to over-express thioredoxin.

Existing indicators of allergenicity revolve around the specific amino acid sequence of the protein, its relative abundance, the presence of post-translational modifications (especially glycosylation), disulfide bonds, heat stability and digestibility. Limited success to date has been experienced using animal models (mouse, rat, guinea pig and pig), but Buchanan’s team have reported good results with the dog model for the study of wheat gliadins and beta-lactalglobulin. The dog possesses many desirable features that animal models should share with humans, including display of allergy symptoms, the relative susceptibility profile (peanut > milk > spinach leaf) and characteristics of the gastro-intestinal system.  Further development of such models will form an important adjunct to existing test methodologies for predicting potential allergens in GM foods.

Somewhat out of place in a programme that emphasized GM plant innovation, Butch Mercer (Global Business Leader, Dow Agrosciences) discussed advances in animal healthcare as a component of HACCP quality control regimes, and highlighted the growing threat from microbial pathogens.  The cost of food-borne microbial disease to the US has been high, with Escherichia coli 0157:H7 representing a “wake-up call” to the public, and species such as Salmonella, Listeria and Campylobacter jejuni representing equally serious threats to human health. For example, Listeria has a 5.4% death rate in the US, while Salmonella cost the US economy in the region of US$2.3 billion last year (in treatment costs, recall of products, lost productivity, etc.).

According to Mercer, the seven-step HACCP approach represents the most powerful tool to combat pathogens, and can be bolstered by deployment of competitive exclusion products, vaccines and antibodies. For example, the ‘PREEMPT™’ spray (MS BioScience, US), originally developed by USDA scientists (approved March 1998), comprises 29 strains of non-pathogenic bacteria which can competitively exclude pathogens from the gut of newly hatched chickens.  New vaccines such as Megan Vac 1 (Megan Health Inc., US), a doubly deleted mutant of S. typhimurium for use in the poultry industry, and also new bacteriophage products in development, are all expected to yield major advances in animal disease prevention over the coming years.

Terry Medley (DuPont Biosolutions Enterprise, US) chaired the session on safety and regulatory oversight of novel crops.

Safety and Regulatory Oversight of Novel Crops Symposium:  A Public Discussion

In opening this well-attended session, Terry Medley (Vice President, Global Regulatory Affairs, DuPont Biosolutions Enterprise) suggested four important criteria by which the federal agency speakers should examine the issue of GM food safety: How comprehensive are the existing regulations, and are we presently asking the right questions?  How commensurate with the perceived risk are those regulations, and is there currently under/over regulation?  Are the regulations sufficiently transparent regarding that which is required from producers?  Finally, how conclusive is the current law-making process, and is there sufficient opportunity for input into the decision-making system?

James Maryanski (Biotechnology Coordinator, Centre for Food Safety and Applied Nutrition, FDA) reviewed the FDA approach to food safety and the current thinking on the labeling issue for GM foods in the US. While about 50 GM food products have been approved since the original ‘pathfinder’ FlavrSavr™ tomato in 1994, the FDA are apparently conducting very few consultations with industry at the moment, which he felt was due to companies working on new ‘second generation’ GM products targeted at consumer benefits.

James Maryanski (FDA), speaking on the use of GM plants for non-food crops (industrial products, pharmaceuticals), said that “at some point we’re going to have to make sure that these products don’t find their way into the food supply”.

 The FDA regulatory stance on foods derived from new plant varieties has not changed significantly over the years since the 1992 ‘Statement of Policy: Foods Derived from New Plant Varieties’ was first published, and this has withstood legal challenge in the courts in the intervening time period.  The key points of this policy include the acceptance of “today’s food” as a yardstick for comparison (and evaluation of new varieties relative to traditional counterparts), and the use of a multi-disciplinary approach in conducting an assessment (encompassing agronomic and quality characteristics, and a consideration of genetic, chemical, and nutritional factors).  If questions remain after this process, an extensive investigation of potential toxicological effects is performed. Information supplied by product manufacturers must include a full appreciation of modifications, both intended (affecting such aspects as digestibility and dietary exposure) and unintended (looking for possible genetic instability and toxicants). 

In January 2001, the FDA announced its intention to increase the transparency of the process by which it assesses bioengineered foods.  Proposals include the requirement for companies to notify FDA 120 days prior to marketing a new GM food, a provision for voluntary labeling (no basis, but important that if there is a label it must be truthful), formation of a biotech advisory subcommittee (comprising a group of experts from outside FDA) and in-house research mostly directed at examining allergenicity. Maryanski thought that US consumers would prefer labels.  However, phrases such as ‘GMO’, ‘free’ and ‘modified’ are not favoured terms.

Looking to the future, key aspects for US regulatory vigilance will relate to the presence of unintended/unlawful GM varieties in food and feed (for example, the StarLink™ corn debacle), inadvertent cross-pollination of varieties, and finally, the use of plants for non-food crops, such as pharmaceutical and industrial products - “at some point we’re going to have to make sure that these products don’t find their way into the food supply”.

Marcia Mulkey (EPA) admitted that EPA learned the important lesson (from StarLink™) that it did not have the capacity to stop (GM) animal feed products being channelled into the human food chain.

John Payne (USDA) pointed out the need for new policy directions in the area of seed purity.

Completing the triumvirate of US agencies with primary responsibility for regulating biotechnology in the US,  John Payne (Associate Director of Plant Health programmes for Plant Protection and Quarantine, Animal and Plant Health Inspection Service, USDA) reviewed USDA’s role in regulating the movement, field testing and importation of GM plants. While a coordinated framework for biotech was originally designed in 1986, recent developments have included increased accountability and efficiency: APHIS is the first regulatory agency in the world that has registered its administrative function using ISO9000 standards.  Highlighting three key aspects for future attention, Payne identified the need for new policy directions in the area of seed purity (certification) standards, detection of the adventitious presence of GM material, and also a special consideration of  transgenic arthropods. 

Lynn Jensen (National Corn Growers Association, US) on the US farmer: “they make decisions on economics, but they will never sacrifice safety for economy – they raise their family on the farms”.

Professing to bring a “real life perspective to affairs of the countryside”, Lynn Jensen (Chairman of the Board, National Corn Growers Association) represents the interests of US corn growers, working with governmental agencies and industry to develop uniform systems and standards for biotechnology. Jensen described how the complexities of international trade have partly offset the benefits of GM corn.  Following its introduction in 1996, about one third of US corn acres have come to be planted with biotech seed.  However, with the adverse response from the EU beginning in 1998, corn wet mills have increased efforts to keep EU-unapproved corn out of their system. Last year, in the domestic market, there was a significant disruption in corn marketing, as industry worked to contain and channel StarLink™ .

The lessons learned from the StarLink™ debacle were clear to Jensen:  commodity grain cannot be channeled to meet a zero tolerance, and both pollen drift and the difficulties in assuring seed purity exacerbate the problem. Commenting on the difference in acceptance rates of GM produce between the US and EU, Jensen felt that US consumers have a higher level of trust in testing and governmental review.  Additionally, he cited better public education on the US regulatory system, the active promotion of food safety, and the direct answering of unsubstantiated claims.  The integrity of the US farmer also has a role to play: “they make decisions on economics, but they will never sacrifice safety for economy – they raise their family on the farms”.

Further concerns raised by Jensen included unmet farmer expectation regarding GM technology, the liability issue regarding adventitious contamination (and the concerns of the export buyer and consumers), the development of pest resistance, tiered pricing systems and inadequate information flow between federal and state agencies.

Doug Gurian-Sherman (Biotechnology Project Centre for Science in the Public Interest, US) strongly criticized the US GM regulatory system.

In a talk aimed at analysing consumer confidence and acceptance of GM produce in the US, Doug Gurian-Sherman (Co-Director, Biotechnology Project Centre for Science in the Public Interest, Washington, US) recognized that current GM crops do possess tangible benefits.  In the latter regard, he mentioned facilitation of increased no-till cultivation, and also the prospect of increased yields and reduction of non-renewable inputs per unit harvest.  However, he contended that the power of the technology left it open to abuse, and also that consumers see direct benefits going to farmers while they live with the risk.  He criticized the current US regulatory system, declaring that it was “cobbled together” in the eighties, and cited a major weakness as the absence of a formal approval process (holding that FDA does not conduct a comprehensive scientific review of data generated by the developer).  He also maintained that industry drives the safety testing agenda, with FDA giving feedback on the company’s own data. 

Further suggested shortcomings were cited as the closed approval process at FDA/CVM for transgenic animals, and the lack of formal GM plant regulations and testing guidelines at EPA (coupled with weak enforcement and monitoring).  He felt that USDA/APHIS had historically demonstrated inadequate rigour on environmental issues. An example of this was the current management strategy for Bt crops in the field, which Gurian-Sherman contended would not prevent development of resistance in pests.  He held that the refuge approach is one-dimensional, and does not adequately address some secondary pests, while it also receives a low compliance rate from farmers.  In closing, he called for independent GM risk assessments and increased research on sustainable production, as well as the adoption of organic and small farm-compatible practices.

Susan Ferenc (Grocery Manufacturers of America):  the US GM regulatory system “needs fine tuning rather than overhaul”.

The Grocery Manufacturers of America supports voluntary GM labeling. Ferenc felt that as foods were not typically ‘genetically engineered’, it was therefore understandable that consumers would want labeling.  However, she commented that terms such as ‘GM-free’, ‘non-GM’, ‘GMO-free’ and ‘non-GMO’ were all potentially misleading.  She firmly believes that there is adventitious co-mingling of GM and non-GM produce, and until thresholds are set by EPA or FDA, there will be significant testing issues that need to be addressed.  At the other end of the spectrum, she was opposed to any false or misleading implication of superiority, safety or quality of foods not derived through modern biotech. 

Thomas McGarrity (University of Texas) emphasized that public trust is essential for the future of biotechnology.

Providing a legal perspective on the GM regulation issue, Thomas McGarrity (JDW Kronzer Chair in Trial and Appellate Advocacy, School of Law, University of Texas) felt that public trust was essential to the future of biotechnology. While declaring that he thought the US regulatory system was comprehensive, he suggested that it could fall apart if challenged in the courts, and had a “fairly thin” legal basis.  He called on Congress to consider a unified agency (FDA-EPA-USDA) and felt that the US public will seek product labeling in the future.  Extending the discussion beyond food, he predicted that plant-based agriceutical products would pose similar problems to those witnessed with StarLink™.

Planting the Future through Space

In a surprisingly poorly attended session, Blake Powers (Director of Outreach for NASA Space Product Development programme) introduced the use of space and microgravity in producing new crops and rapid “need-feed” technologies. This mission is being pursued by NASA in partnership with a number of commercial space centres across the US (usually based on a university campus), each with a specialty in industry-defined aspects of plant science.

Weijia Zhou (University of Wisconsin, US) discussed the potential of extra-terrestrial biology.

In the first of three Centre presentations, Weijia Zhou (Director, Wisconsin Centre for Space Automation and Robotics, University of Wisconsin) reviewed representative activities in engineering (telerobotics) and plant research (enhancement of synthesis of secondary metabolites, cell transformation and nutriceuticals). Programmes in telerobotics and automation have produced systems that can perform autonomously defined experiments, conduct field sampling (being pursued for coffee-field harvesting), perform transplant experiments in space, and carry out precision farming technology (using sophisticated image discrimination, stress identification and insect warning systems). 

Altered plant metabolism and genetics due to cultivation in microgravity has enabled commercially valuable advances such as the production of dwarf wheat varieties, the isolation of anti-inflammatory compounds from Ginkgo Biloba, and selected modification of the starch content of potato tubers.  Previous work on production of essential oils from the rose, coupled with solid phase microextraction to capture volatile scents released by the plants in microgravity, has previously resulted in successful product development.  Additionally, improved transformation efficiency is being studied for soybeans, while experiments currently being conducted on the International Space Station involve Arabidopsis (analyzing and comparing the chemical characteristics of the seeds produced on Earth and in space).

Anthony Pometto (Iowa State University, US) described novel food processing technologies for long-duration space missions.

Contrasting with this, Anthony Pometto (Director, Food Technology Commercial Science Centre, Iowa State University) discussed his centre’s role in developing food processing technologies for long-duration space missions.  The Iowa team is working with a variety of commercial partners such as Pioneer Hi-Bred, Kraft and the Iowa Soybean Promotion Board. Contrary to popular belief, astronauts receive their nutrients through meals rather than pills (with the exception of Vitamin D). Loss of bone mass is a serious problem, and this has led to major research programmes at the Iowa Centre into such products as calcium-rich snack bars. Other food research is ongoing into probiotics, food encapsulation systems (micronutrients and flavours), low fat soya products and general space menu development. Pometto described the challenges of catering for the space environment. The absence of gravity demands ‘crumbless' bread, and therefore extending the shelf life of tortillas has been an important research goal.  The non-viability of refrigerators or freezers in space has also required the development of new drying and additive technologies. Packaging food is equally important, with the urgent need for edible and degradable plastics, while biotechnology is also being applied to odour control and waste management on board the Space Station.

Stephanie Countryman (Business Development Manager, BioServe Space Technologies, University of Colorado) described unique pharmaceutical testing and production systems which are being developed in microgravity environments.  For example, the efficacy profile of ostegprotegerin, a drug in development for treatment of osteoporosis, is being tested in space for altered characteristics. Experiments looking at microbial-based antibiotic production have reported 75% - 200% increases in yield.  Other topics under investigation include microbial drug resistance and mammalian cell stabilization. 

In agriculture, lignin biosynthesis is strongly influenced by microgravity conditions, and this is being exploited in transgenic trees as an aid to pulping for the paper industry.   Other areas of focus include the study of nitrogen-fixation by rhizobia, the use of microgravity in the manipulation of natural plant products and the development of in-space production technologies, such as the ‘Plant Generic Bioprocessing Apparatus’ (which has a gas exchange capability and water-nutrient support system).  The space growth profiles of such model plants as Arabidopsis, Artemesia annua and Pinus taeda (loblolly pine) have been defined and characterised.

Richard Vierling (Producer’s Natural Processing Corporation, US).  PNPC are one of a number of companies investing heavily in the potential of genomics conducted in a microgravity space environment.

Industry collaboration is a key component of the NASA Science Centre concept, and Richard Vierling (President, Producer’s Natural Processing Corporation) described his company’s strategic interest in space. Indicating that not all desired properties can be sourced from terrestrial plants, PNPC have deployed a combination of microgravity, genomics and plant transformation to try to produce novel functional foods and pharmaceuticals  for human health.  The attractions of microgravity for improved plant cell transformation include increased frequency and reduced time, while the process is both genotype- and species-independent.  A soybean seed coat production system has been developed which allows high  production  of  protein (within hourglass cells) at an agricultural cost (extraction requires 1 kilogram seed coats per 2 litres of water; yield is 5,400 grams/acre).

Linda Thrane (Council for Biotechnology Information, US):  “biotech is a global issue of meaning to people at different levels”.

Accepting New Techologies:  Media and Public Perception of Risks and Benefits

In one of the best attended sessions of the agri-food theme, chairperson Linda Thrane (Executive Director, Council for Biotechnology Information) opened the discussion by restating the perception problem regarding biotechnology, and highlighting the fact that “biotech is a global issue of meaning to people at different levels”.

Couched very much in terms of the fall-out from the StarLink™ episode, Jennifer Sosen (Senior Managing Director, KRC Research) outlined CBI’s research programme for tracking public reaction to biotechnology, and also discussed the latest results from such surveys.  Over the past few years, CBI have routinely conducted quarterly random sample surveys, complemented by occasional ‘special type’ studies (for example, in response to StarLink™).  Such work is supplemented by ongoing qualitative exploration of the salient issues. The results from their latest work indicate that for most US consumers, biotechnology is still “low on the radar screen”.  However, awareness is increasing, especially regarding the benefits. When asked over time whether “you personally have heard the story regarding StarLink™”, awareness increased steadily from 28% of the poll in September 2000, to 39% in October and 58% in November. While StarLink™ had an impact on both the awareness and concerns of US citizens, more Americans continue to accept agbiotech than reject it.  The average person interpreted the StarLink™ episode as an indication that the US regulatory system works. Conversely, most people in the US continue to think they have not yet eaten GM foods. 

While the majority of people support the use of biotechnology in agriculture, acceptance is often based on the language used to convey the information.  Opposition was found to be higher when the phrase ‘genetically modified foods’ was used, and this phrase definitely raises concerns for people.  When benefits are mentioned, the support for biotech can be substantial.  In closing, Sosen expressed her conclusion that “among US consumers, information leads to positive judgement”.

An alternative perspective was provided by Michael Rodermeyer (Executive Director, Pew Initiative on Food and Biotechnology), with his survey research indicating that US consumers now question their government’s ability to manage GM foods. However, when it comes to food safety, consumers are most concerned about food poisoning and food freshness. Similar to Sosen’s findings, his results indicate that US consumers are steadily starting to hear more about GM foods, with regional variations in opinion evident, and better awareness currently in the western US. An overwhelming majority believes it is important to know whether or not a food product is GM (75% of poll conducted in January 2001). While many US citizens tend to have a positive view of organic foods, they look negatively on issues such as biotechnology, irradiation and GM foods; Rodermeyer has found that a majority actually opposes the introduction of GM foods into the food chain.  Countering this, a majority who have already eaten GM foods believe they are safe, but most would also like to see continued scientific research on this area. The recent positive review of StarLink™ corn by the Centres for Disease Control and Prevention (CDC), which eliminated it as a cause of allergic responses in humans, has not bolstered confidence in GM foods. 

In terms of who is most trusted by the US public regarding information on the safety of GM technology, Rodemeyer’s results indicate that FDA leads the field, followed by food safety groups, farmers and scientists.  Extending the debate to GM arthropods and fish, he highlighted that as one moves up the evolutionary chain, the “comfort level” with GM technology decreases.  However, he concluded that the “US consumer opinion is still up for grabs”.

Wyatt Andrews (CBS News, US):  “where is the Golden Rice?”

In a non-compromising, witty and entertaining presentation, Wyatt Andrews (National Correspondent, CBS News, US) declared that the biotech industry needs to recognise it has a serious PR problem, with “GM food getting ahead of the information”, and unanswered questions regarding the benefit to consumers.  He emphasized that the US public wants GM product labels, opining that the public debate on this topic is not shaped by the science, but by emotion.  This was a visceral fear, with the “Jurassic Park” phenomenon still ripe in peoples’ minds. He castigated the industry for promoting biotechnology as being no different to conventional breeding, calling it a “totally unconvincing act”.  Posing the question, “where is the Golden Rice?”, Andrews called on the industry to work harder to get these innovations to the people in need. 

He concluded with an appeal to scientists to give on-camera interviews regarding GM innovation, and singled out companies such as Aventis and Dow for their reluctance to go beyond telephone interviews (a criticism he also leveled at the CDC and FDA, while EPA was praised for eschewing this trend). In closing, Andrews reiterated that the industry must engage the debate and take opportunities to speak to the media: “We’re not anti-biotech, we are pro-news”.

The Global Trade Dilemma

Craig Thorn (Partner, DTB Associates) emphasised that the surface has only been scratched regarding the potential of biotechnology, and adoption rates have far exceeded those of other technological innovation in the last few decades. Despite this, countries such as the US, Canada and Argentina are very export-dependent, and the resistance of the EU to agribiotech innovation has led to hundreds of millions of dollars being lost to the US.  Furthermore, draft EU legislation in the pipeline could lead to US farmers losing much more.  The potential for trade disruption was therefore significant if there was a failure to reach a common understanding on GM technology.

In a presentation which provided a general overview of the state-of-play in international GM product trade, Bernice Slutsky (Policy Advisor, Foreign Agricultural Service, USDA), articulated the conventional US stance on the negative reaction to biotech by some other countries.  Not since hybrid corn seed has a technology been accepted so readily by US farmers:  GM crops already represent 25% of US corn and 60% of US soybean and cotton.  She felt that the integration of biotech into agriculture was assured, but that this issue also raised some crucial points. Of central importance, the insistence by “countries that don’t have a mature approach to biotechnology” to impose impractical regulations represented a significant hurdle. 

Safety regulations needed to be predictable and objective to companies, and comprehensive and transparent to consumers.  In this regard, Slutsky saw no reason for a new institution in the US to regulate biotech.  Additionally, safety regulation needed to conform to the “realities of the agricultural system” and be science-based, an aspect she felt was absent in many other countries. She did not object to labeling and provision of consumer information per se, provided it was truthful and not misleading.  However, she thought that factors such as the cost of compliance, setting threshold levels, verification tests and enforcement were all issues that cast severe doubt on the practicalities of implementing GM labeling. In closing, Slutsky called on the Codex Alimentarius Committee on Food Labeling to consider such ‘real life’ factors in its discussions (it is expected to set an international standard for labeling of GM food in 2003).  She also felt that the OECD seed scheme would help governments arrive at a common understanding of seed purity, emphasizing that the USDA would work voluntarily with other seed exporting countries to reach a consensus.   

Richard White (US delegation to WTO) expressed that food safety should be a partnership between the private and public sector.

A similar line of argument was pursued by Richard White (Office of the US Trade Representative, US delegation to WTO). Speaking from first-hand experience of negotiating international trade agreements, he felt that food safety was a partnership between the private and public sector.  While the system was not perfect, it was based on scientific evidence, and measures should not be more restrictive than necessary to meet those requirements.  Although the Codex Alimentarius Commission is made up of scientists, White articulated that the US wanted trade interests factored into their decisions, as the Codex mandate is to ensure fair trade practices in food and food safety.

Having the difficult job of following much thinly disguised criticism of EU policy on GM technology, Lars Mitek-Pedersen (European Commission, Office of the Secretary-General) undertook to review developments in the EU, examining “what is possible and not possible for the future”, and providing an update on the types of regulatory measures being considered in Brussels. While agreeing that the GM issue has had a negative impact on bilateral trade between the EU and US, he added that this was also influenced by weak world commodity prices and new competitive exporters of the same crops as the US.  The standstill in product approvals in the EU since February 1998 was an undoubted problem, but he maintained that 100% of GM soya and 97% of corn has access to the EU, and “therefore, the effect of the moratorium has probably been limited”.  He did acknowledge the regulatory burdens on placing products on the EU market, holding that its regulatory system was one of the “strongest/most rigorous” in the world.  Additionally, post-marketing requirements are an issue, especially regarding labeling and traceability.

Lars Mitek-Pedersen (European Commission, Brussels, Belgium) highlighted that a key philosophy of the EU regulatory approach is a desire to give consumers the best framework for making choices – “if they decide not to eat GM products, then so be it”.

The key philosophy of the EU regulatory approach is a desire to give consumers the best framework for making choices, and “if they decide not to eat GM products, then so be it”.  Mitek felt that companies (and by inference, governments) would have to face up to the changing regulations in the EU, using more efforts to sell such products;  he felt that the markets would soon adapt. However, he did not think there was any ‘quick-fix’ solution to trading in Europe in these products, as the EU public is all but indifferent to biotech.  While there is a case for the European Commission and national governments to educate the public, this would not be with the message that “you should consume GM foods”.

Mitek opined that the rising trend for EU consumers to reject GM produce has been exacerbated by retailers who have often chosen more radical GM restrictions than those proposed by the EU regulators.  In the latter regard, he specifically mentioned Pepsico, Coca Cola, Heinz, Campbell Foods, Burger King and McDonalds Europe.  Elaborating on this point, he outlined how some have developed regulations where none exist, eliminating GM totally or even stipulating acceptable animal inputs.  This, in turn, has amplified consumer concerns.  On the macro level, EU member states have largely based their individual policies on the perceptions of their own consumers, and he added that many problems within the Community are down to differences in opinion between the EU (Brussels) and the ‘EU-15’.

Mitek then moved on to discuss the package of additional measures being contemplated by Brussels to supplement existing GM regulation. Firstly, a specific framework for approval of animal feeds will be created to tackle the GM feed issue (there are no labeling or approval regulations in place at the moment in the EU).  Secondly, there will be easier access for biotech crops to the EU market;  however, specific traceability requirements will be regulated by a general food law, reflecting a stronger emphasis on the food chain.  Regarding the adventitious presence of unapproved GM material, while in current legislation there are no explicit provisions for such a content, new tolerances under certain conditions will be introduced. Most controversially, while there is already mandatory labeling when products include traces of GM ingredients, this will be extended to situations where GM components cannot be detected due to processing. Mitek was dismissive of arguments against commodity segregation, and indicated he had information that some US grain shippers were quite willing to ‘top up’ identity-preserved consignments with whatever was available.

In closing, Mitek called on the EU and US to work together on this issue, opining that this had not been a strong point in the past, with missed opportunities for joint policy development - “we have missed the boat on sampling and testing, unique ID for traceability and wider issues such as precaution and scientific uncertainty”.

Responding directly to the review of the EU regulatory environment, Mike Phillips (Executive Director, Food and Agriculture, BIO) indicated that the US was “diametrically opposed” to the consumer-led attitude to GM foods in the EU, and further disagreed with its proposals to make GM regulations tighter. 

Mike Phillips (BIO, US) indicated that the US was “diametrically opposed” to the consumer-led attitude to GM foods in the EU.

Traceability can entail high costs, and therefore sound justification would be required for continuance of this policy. He highlighted that EU draft regulations were silent on how information would be developed, and implied event-specific testing at origin/destination. The possibility of such testing raised a number of questions, but the over-riding issue was one of accuracy.   For example, this area is an evolving science, and while good tests exist for DNA, there would be a long way to go before definitive tests for the proteins were available;  pursuing such a strategy in the absence of reliable tests would run the risk of a high number of false positive reactions.  The cost of testing was an equally important aspect, with Phillips estimating US$700 per sample and US$25,000 per vessel -  “grain exporters are not willing to take on these costs by any stretch of the imagination”. Additionally, he did not think that destination testing would be acceptable to grain exporters around the world.  Finally, he felt that GM labeling further reinforced the EU consumer perception that these foods are less safe than their conventional counterparts. He strongly questioned the reasoning behind the extension of labeling to packaged products where no residue of GM exists - “if you can’t find it, how can you regulate it?”  US producers of raw ingredients for processed foods stood to lose a major export market, while an extension to animal feed could affect a US$4 billion market.

Phillips noted caustically that the EU Proposal did not include EU-produced ingredients, such as enzymes derived from biotech, and said that the new measures would be a violation of WTO.  To Phillips, this was more than a debate or dispute between the US and EU - the rest of the world is watching and listening.

Val Giddings (BIO, US) declared that the ‘green’ point of view is “represented by the people in here and not the minuscule numbers of  (anti-GM) protestors outside the building over the last few days”.

Lack of Global Harmonisation and Challenges for Developing Countries

In opening the session, Val Giddings (Vice President, Food and Agriculture, BIO) declared that the ‘green’ point of view is “represented by the people in here and not the minuscule numbers of (anti-GM) protestors outside the building over the last few days”.  He provided a brief analysis of the dilemma facing developing nations, where such countries are attempting to adopt GM technology in the face of conflicting worldwide regulations.

Jocelyn Webster (Executive Director, AfricaBio) dealt with lack of global harmonisation and challenges for developing countries, using South Africa as a case study.  Around 50 – 75% of the labour force in Africa is involved in agriculture.  However, African crop production is the lowest in the world (at about 1.4 tonnes per hectare).

The South African government implemented a new GMO policy in 1999, and there were 3 commercial approvals by the end of 2000.  There are currently about 110 plant biotech groups (academic and industrial) and over 160 projects ongoing.  About 45 companies are using biotechnology in food, feed and fibre.  Webster referred to the predominant plant science research activities as “second generation biotech”, involving the tissue culture of such crops as cassava, yam, pineapple, cocoa and  banana.  

Jocelyn Webster (AfricaBio, South Africa):  “protection of markets through artificial trade barriers creates distrust and isolation”.

However, genetic engineering projects are well advanced and are aimed chiefly at pest and disease control and production of drought and cold-tolerant crops (sweet potatoes, bananas, sugar cane, sorghum and maize).  Molecular markers for use in plant breeding programmes are also important. 

Webster identified the major problem regarding GM technologies for Africa as the need to develop an adequate biosafety structure, but qualified this by indicating that such measures should not be too restrictive.  Countering this, the African public is not well informed on GM issues, and anti-biotech activists (especially from Europe) are making a significant impact. There have been many poorly researched documentaries and articles in the media, with resultant confusion in the public, and an increase among those who are opposed to GM technology.

She contended that contrary to popular belief, the major beneficiary of GM will be the small-scale farmer.  However, trade issues were jeopardising the future of African farmers who are trying to adopt this technology.  For example, Namibia (a significant beef exporter to the EU) has stopped importing South African maize for fear of upsetting EU customers, despite the fact that only 6% of the maize is GM. She opined that regional and international policy development should facilitate trade and not hinder it between Africa, Europe and Japan – “protection of markets through artificial trade barriers creates distrust and isolation”.

Closing her presentation with the point that “South Africa needs biotech”, Webster further highlighted a need for more successful product demonstrations, so that the public can see a net benefit, and also called for the creation of platforms for sharing and developing a strong unified voice in Africa

Building on this theme, and relating similar experiences in Kenya, Florence Wambugu (Director, ISAAA AfriCenter, Kenya) echoed Webster’s assessment of the agri-food situation in Africa.  Inadequate food supply has been exacerbated by the use of unsustainable agricultural practices.  There is poor funding for research, in many cases representing less than 0.5% of national budgets, coupled with low technology transfer activities and policy limitations.

Florence Wambugu (ISAAA AfriCenter, Kenya):  “chemical technology has not helped the African farmer”.

In a typically frank presentation, Wambugu highlighted a number of issues which will need urgent redress.  Africa must significantly increase its food production capacity:  while the population is increasing at a rate of 3.5%, food production lags behind at 2.5%. When coupled with a declining unit of land per family, significant pressure is being placed on the ecosystem.  Biodiversity must be preserved by reducing chemical inputs (“chemical technology has not helped the African farmer”) and modern biotechnologies need to be integrated into cultural practices.  The enhancement of seeds is a significant advance for Africa and is assured to result in increased productivity, profitability, and time-saving, in addition to reducing the need to weed. A powerful example of the benefits of biotechnology can be seen in the case of Maize Streak Virus, a major problem which has caused yield losses of about 20 – 100% in some years.  Over twenty years of conventional breeding research in Kenya had not resulted in varieties that were resistant to this pathogen.  However, the Kenyan Agricultural Research Institute has developed an MSV-resistant hybrid through recombinant DNA technology within a relatively short 5 year period.  A number of recombinant MSV hybrids are now being evaluated in national performance trials.

Echoing Jocelyn Webster’s points regarding specific challenges facing Africa, Wambugu stressed that the poverty of African farmers dictates that a form of sustainable micro-credit scheme be organized to help people invest in GM crops.  The African public acceptance of this technology is not yet assured, and Wambugu strongly criticized European anti-biotech groups who are spreading misinformation and preying on the minds of poorly educated farmers.

In a talk entitled ‘sitting on the fence:  biotech in developing countries’, C.S. Prakash (Director, Centre for Plant Biotechnology Research, Tuskagee University) highlighted that while the Green Revolution lifted billions of people out of poverty, there continued to be an urgent need for increased food self-sufficiency.  Without a significant increase in farm productivity, an additional 1.6 billion hectares of arable land will be needed in the future.  In the face of this crisis, certain countries in need of biotech advances are ‘sitting on the fence’, with Prakash specifically singling out Brazil, Mexico, India, Philippines, Thailand and Egypt for attention in this regard.  He suggested that such tardiness regarding adoption of biotech crops was due to a combination of the regulatory impasse in the EU and consequent trade fears, together with activist pressure and political convenience.  In a rather tenuous analogy, he posed the question that if “you don’t need to ask permission to bring a mobile phone into South Africa, why ask regarding a GM plant?”

Agricultural Biotechnology: from Farm to Pharm

Providing an industrialist’s viewpoint, Guy Cardineau (Global Leader, Research and Development, Dow AgroSciences) recounted the brief history of transgenic plants.  He led the audience through the reports of the first GM plants in January 1983, to the first field-tests of Bt tobacco (1986),  the subsequent public debate in the US and formation of regulatory frameworks, and finally, the FlavrSavr™ crop reaching the market in 1994/1995.  In this first generation of seeds, input traits (insect and herbicide resistance) rather than output traits were important, as the customers were farmers.  GM crops are now predicted to total greater than US$200 billion by 2010, but on a technological level, Cardineau described Bt technology as a relative “no-brainer”.  Much of the technology seen to date has been limited to 1 – 2 genes and has been targeted at a known market.  However, we are now entering an era where sophistication in the technology means that the advantages of plant-based production (such as low cost, low capital investment and facile scale-up to unlimited quantity) can be harnessed to produce high value product, such as pharmaceuticals - “a biotechnology transition in manufacturing from the steel plant to the green plant”. 

In a talk entitled ‘plants as plants: an industrial biotech perspective’, Hank Kohlbrand (Director, Biomaterials Platform, The Dow Chemical Company) provided a fresh interpretation of biotech as another way of doing chemistry. Biotech has held up the real possibility of improved economics in new processes, offering lower fixed/variable costs, while also generating renewable resource products with a reduced ‘environmental footprint’.  Biotech routes used to achieving this depend on multi-disciplinary approaches  using fermentation, biocatalysis, genomics, metabolomics and protein engineering.  Dow is applying these technologies to industrial enzymes, production of monoclonal antibodies in plants and production of new plant oils.

At the other end of the spectrum, Jay Shortt (CEO, Diversa Corporation) demonstrated a platform technology-led approach from an entrepreneurial bioscience player. Here, accelerated molecule discovery technology allows the company to screen for novel biological activities in a relatively short time period.  Using the example of a dry, sandy Californian alkaline soil, derived from an area of sparse vegetation, Shortt demonstrated that no less that 120 unique esterase activities could be isolated by actively screening via heterologous expression in a new host.  Such screens are automated and can be conducted in 100,000-well plate systems.

In a presentation focused on plantibodies, Mich Hein (President, Epicyte Pharmaceuticals, Inc) outlined that cost and capacity are currently a significant limiting factor in producing monoclonal antibodies by conventional hybridoma technology;  additionally, fears regarding zoonotic contaminants are still present.  However, plants can produce any antibody isotype, and it is possible to produce a human antibody in a crop plant such as corn or rice which can then be purified and used as a prophylactic or a therapeutic.  Correct antibody assembly is carried out by crossing the ‘heavy chain’ plant with the ‘light chain’ plant to make an ‘immunoglobulin plant’, with the assembled antibody accumulating in the seeds.

Opportunities for immunotechnology are booming: there are about 500 antibodies in development today, with US$4 billion in sales predicted by 2004, and products for chronic care and prophylaxis projected to require metric tonnes per year.  Hein contended that plants would be needed to reach this scale of production.

Charles Arntzen (Florence Ely Nelson Presidential Chair, Department of Plant Biology, Arizona State University) described the state-of-play in producing edible vaccines in plants.  Arntzen and his team chose the existing recombinant hepatitis B vaccine as a model system, as it represents the ‘gold standard’ in recombinant vaccine technology. The hepatitis B vaccine is made by cloning a gene from the virus into yeast.  This vaccine requires 3 shots at about US$75 per dose.  However, for the design of a vaccine for the developing world, about 10 US cents per dose are the upper cost level.  Recombinant expression in plants has the potential to achieve such economics.

Arntzen’s team has successfully expressed hepatitis B surface antigen in transgenic tomato cells.  Curiously, a form of self-assembly of the antigen into tubular structures occurs in the endoplasmic reticulum during this process. In terms of production, issues for further study and characterisation include antigen accumulation and the levels of gene expression, antigen yield per acre of crop and geographical flexibility.  For processing of the plant, aspects such as antigen stability/loss, the process costs and immunogenic potential are all critical. Additionally, sophistication regarding dosage is required, as patients cannot simply eat any amount of the vaccine. 

Arntzen closed his presentation by indicating that USDA and FDA are currently cooperating on the development of a new regulation for plant-based manufacture of macromolecule drugs.  Early products for approval consideration will be monoclonal antibodies (mainly from maize seed) and a vaccine for animal agriculture.