November 2001


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Evaluation Of US Biotechnology Regulatory Process
Reporting In: New Zealand Government Outlines Policy On Genetic Modification
Engineering A Shared Pathway To Salt And Drought Tolerance In Plants
Tandem Gene Orientation Reduces Transcription Interference
Potential Environmental Risks And Hazards Of Biotechnology
Life Sciences And Biotechnology–A Strategic Vision For The European Union
Upcoming Meetings

CAST Scientists Issue Urge Government to Increase Public Access to How Regulators Make Decisions

Washington DC Regulators need adequate resources to make more information available to the public about how decisions on biotechnology are made, according to a new Council for Agricultural Science and Technology (CAST) issue paper. The "Evaluation of the US Regulatory Process for Crops Developed through Biotechnology" paper includes recommendations for policy and research in agricultural biotechnology. It is particularly timely as the Environmental Protection Agency is making decisions regarding the registration fate of biotechnology-derived crops, such as Bt corn.

A group of nine science and policy experts prepared the issue paper for CAST, which represents 36 food and agricultural scientific organizations. "Having accepted the unenviable task of evaluating how US regulatory agencies determine the safety of biotech crops, we decided to describe the process, then comment on how the process can be improved," explained food safety expert Bruce Chassy of the University of Illinois.

The paper's authors found that the US regulatory process for evaluating biotechnology-derived crops is comprehensive and meets its charge of ensuring that biotechnology-derived foods are at least as safe as foods derived using traditional breeding techniques. "The greatest challenge is not having access to the documentation on how Regulators come to their decisions," said Chassy. "We believe the public would have more confidence in the process if they knew the rationale for regulatory decisions to accept or reject new biotech crops. Safety testing data are available to the public. Now we need to provide adequate resources so the regulators can explain their decision-making rationale."

Four Key Questions Evaluated
The authors addressed (1) How are safety assessment and regulatory reviews conducted? (2) Can obvious strengths and weaknesses of that process be identified? (3) Can improvements be made in conduct and direction of independent research, in performance of safety assessments, in opportunities for consumer participation, or in any other aspects of the regulatory process that will both enhance the quality of the assessments and further ensure the ultimate safety of biotechnology-derived crop products? and (4) Are there improvements to the regulatory review process for biotechnology-derived plants that will enhance public confidence in the process?

Policy Recommendations
1.Retain the current case-by-case safety assessment approach and continue to emphasize regulatory conditions carefully tailored to address risks identified for individual biotechnology-derived plant products.
2.Finalize the Food and Drug Administration's (FDA) current proposal for a mandatory, premarket notification in lieu of the present policy of voluntary consultation for all food products of agricultural biotechnology.
3.Provide the public with rapid, comprehensive accessibility to applications and supporting health and safety data submitted to regulatory agencies for biotechnology-derived products.
4.Issue approvals for both food and feed use for crops intended to enter commodity streams.
5.Provide the additional resources sorely needed for key regulatory review functions.

Research Recommendations
1.Conduct additional research on selected topics to ensure that present-day questions can be answered and that future developments will be assessed adequately.
2.Develop rapid screening methods for biotechnology-derived crop proteins in raw agricultural commodities, such as grain and vegetables.
3.Conduct additional research to support regulatory oversight and product stewardship of biotechnology-derived crops currently on the market.
4.Carry out additional research on the potential health, safety, and environmental effects of biotechnology-derived products that are not designed to be substantially equivalent to their conventional counterparts (sometimes referred to as next generation biotechnology-derived crops).
5.Conduct additional research on food allergies and identification and characterization of allergenic food proteins.

CAST and the Authors
CAST publications are prepared by teams of volunteer scientists and science policy experts assembled by CAST. All CAST publications reflect the expertise and views of the authors. The following multi-disciplinary group of scientists and science policy experts prepared this paper:
Bruce M. Chassy, Ph.D. (Chair), College of Agricultural, Consumer, and Environmental Sciences, University of Illinois, Urbana
Stanley H. Abramson, J.D., Arent Fox Kintner Plotkin & Kahn, PLLC, Washington, DC
Anne Bridges, Ph.D., Medallion Laboratories, a division of General Mills, Minneapolis, Minnesota
William E. Dyer, Ph.D., Department of Plant Sciences, Montana State University, Bozeman
Marjorie A. Faust, Ph.D., Department of Animal Science, Iowa State University, Ames
Susan K. Harlander, Ph.D., Biorational Consultants, New Brighton, Minnesota
Susan L. Hefle, Ph.D., Department of Food Science and Technology, University of Nebraska, Lincoln
Ian C. Munro, Ph.D., Cantox Health Sciences International, Mississauga, Ontario, Canada
Marlin E. Rice, Ph.D., Department of Entomology, Iowa State University, Ames

The complete paper, as well as many of CAST's other scientific reports, is available on the CAST Web site < >. Additional copies of the report are also available from CAST for $3. CAST is an international consortium of 36 scientific and professional societies. It assembles, interprets, and communicates science-based information regionally, nationally, and internationally on food, fiber, agricultural, natural resource, and related societal and environmental issues to its stakeholders—legislators, regulators, policy makers, the media, the private sector, and the public.

For more information, contact:
Dr. Bruce M, Chassy
Tel: 217-244-7291/Email:
Cindy Lynn Richard
Tel: 202-675-8333, ext. 12/Email:
Dr. Teresa A.Gruber
Tel: 202-675-8333, ext. 11/Email:
Karen C. Edwards
Tel: 703-281-7600/Email:

CAST News Release
October 11, 2001
Reprinted with permission


The New Zealand government has finally responded to the report of the Royal Commission on Genetic Modification (RCGM)1 three months after its release. The current voluntary moratorium on commercial release of genetically engineered (GE) organisms in New Zealand is to become law for two years. The de facto incomplete moratorium on pre-commercial field trials will end, and trials will be subject to the oversight of the established regulatory authority. All field test sites must be cleared of GE material afterwards via removal or destruction, and no trials will be permitted in which seed is set. GE animals must be tagged for identification in the event of escape, as already practiced. Prime Minister Helen Clark said that New Zealand could not afford to turn its back on advanced science but the government recognized the concerns of some people regarding the technology. The new moratorium is intended to permit more research into the effects of full release, albeit under a regime in which full release is prevented.

The RCGM report was the result of a 14 month process that examined the cultural, ethical, spiritual, environmental, health, economic, and strategic impacts of GE on and for New Zealand.2 It recommended a compromise of `preserving opportunities' between two extremes: (i) that New Zealand become entirely GE-free, or (ii) that GE be permitted without any restrictions whatsoever (a position never advocated by any group). The science community responded that the report was balanced and, while in places lacking scientific objectivity and bowing to political expediency, was a workable basis for practice and legislation. The anti-GE lobby disagreed strongly. The government has now chosen to take a position somewhere between the `green extreme' and the RCGM compromise.

Several factors contributed to the government's decision. Since August, GE-free advocacy groups have successfully marginalized the report with a high-profile public campaign involving local government lobbying, street marches, and the world's longest GE-free sandwich. Billboards of celebrities wearing sloganed T-shirts3 easily grabbed public attention away from complex technical statements made by advocates of responsible GE. Strong objections have also been raised by Maori, many of whom are opposed on cultural grounds to the transfer of genes between organisms. Meanwhile, scientists and businesses suspended progress and made contingency plans for international relocations. Researchers are now cautiously welcoming the government's response, describing it as a significant victory for common sense even though the proposed regime is not ideal and compliance costs for GE will climb even further. Many are pleased that the government has not been entirely swayed by the vociferous minority who found the detailed, complex 1200 page report less digestible than the two-hundred foot sandwich. The issue will however remain alive in New Zealand for the foreseeable future, as the Green party has promised it will campaign in the 2002 general election against all field releases. The end of the two-year moratorium on commercial releases will follow in 2003.



2. Hanley Z, Whittaker D, and Elborough K. 2000. ISB News Report, September.


Zac Hanley and Kieran Elborough
Consultants in Plant Biotechnology New Zealand


The prospect of feeding humanity as we enter the new millennium is formidable. To meet the challenge it is necessary to further increase the productivity of land already under cultivation and to enable agriculture in areas lost due to salinization and scarce water availability. The deleterious effect of salt on plant cells has two components: osmotic stress and ion toxicity. The osmotic component results from the dehydration and loss of turgor induced by external solutes. Osmotic stress also results from desiccation and therefore is a common component of drought and salt stress.1

Salts, such as NaCl, exert their toxic effect in the cytosol of the plant cell. Salt tolerant plants avoid this toxicity by the sequestration of the Na+ and Cl- ions into either vacuoles or roots via a salt exclusion mechanism. The sequestration process is energy dependent, and the source of energy is an H+ electrochemical gradient generated by two vacuolar proton pumps, an H+-translocating ATPase (VATPase) and an H+-translocating pyrophosphatase (VPPase). The H+ electrochemical gradient across the vacuolar membrane permits the secondary active transport of inorganic ions, organic acids, sugars, and other compounds.

In principle, increased vacuolar solute accumulation should have a positive impact on the adaptation of plants to salinity and drought. But how can we improve the existing solute accumulation capability of a plant vacuole? A recent report by Gaxiola and collaborators published in the Proceedings of the National Academy of Sciences (PNAS) offers a possible answer to this question.2 This group reported that two lines of transgenic Arabidopsis thaliana plants engineered to overexpress the vacuolar H+-pyrophosphatase, AVP1-1 and AVP1-2, have enhanced tolerance to salinity and drought stresses compared to wild type (WT).

The enhanced tolerance is most easily explained by an increased uptake of ions into their vacuoles. Presumably, the greater AVP1 activity in vacuolar membranes provides increased H+ to drive the secondary active uptake of cations into the vacuole. Both transport processes will increase the membrane potential of the vacuole thereby impeding further transport of cations. Therefore, a compensatory transport of anions is expected in order to maintain electroneutrality.3

The resulting elevated vacuolar solute content likely confers greater water retention, permitting plants to survive under conditions of low soil water potentials. Furthermore, at high Na+ concentrations, the increased H+ electrochemical gradient could also be used by Na+/H+ antiporters such as AtNHX1, thereby contributing to Na+ sequestration within the vacuole of AVP1 transgenic plants. Presumably, any cytotoxic effects intrinsic to Na+ are mitigated by this sequestration in the vacuole.4,5 Results consistent with this hypothesis are:

1. Immunocytochemical localization experiments show that mesophyll cells of the rosette leaves from AVP1 transgenic plants have higher levels of AVP1 expression than wild type.

2. Na+ and K+ content of rosette leaves from AVP1 transgenic plants grown in the presence of 100 mM NaCl are higher than in wild-type plants.

3. Pyrophosphate-driven 45Ca2+ uptake into vacuolar membrane vesicles from transgenic plants is higher than into wild-type vesicles.

4. Solute potential values of fully hydrated rosette leaves from fully watered transgenic plants are more negative than values from wild-type plants obtain under identical conditions. These data indicate that transgenic AVP1 plants accumulate more osmotically active solutes than wild-type plants, even under non-stress conditions.

5. The relative water content values from transgenic plants are less affected by an extended drought stress. The water content of wild-type plants drops to lethal values after six days of water stress, while transgenic plants do not reach lethal values even after ten days under identical conditions.

6. ABA- and extracellular Ca2+-induced stomatal closure responses are indistinguishable between AVP1 transgenic plants and wild-type plants. These results indicate that differential ion retention and not stomatal closure regulation is the basis for the drought tolerant phenotypes of AVP1 transgenic plants.

The generation of a proton electrochemical gradient across the vacuolar membrane is a universal strategy for energy storage in plants and fungi. This energy is used by secondary active transporters, which leads to the accumulation of solutes in the vacuolar lumen. The accumulation of solutes is followed by water uptake. The overall sequence identity among published sequences of AVP1 homologues, including monocots, is 85% or greater.6 Taken together, these results suggest that the up-regulation of vacuolar proton pumps such as AVP1 in economically important crops holds promise for the reclamation of farmlands lost to salinization and lack of rainfall.

One remaining point of concern is if low quality (high salt) waters are used to irrigate a new generation of salt-tolerant crops, history will surely repeat itself. This practice will eventually result in soils with enough salt to outstrip the protective mechanisms described above. Therefore, research must also focus on alternative irrigation practices that optimize the use of water and also in treatments to optimize its quality. In this regard, transgenic plants such as AVP1 overexpressers offer an attractive alternative to their wild-type progenitors due to their more efficient use of water.


1. Serrano R and Gaxiola R. 1994. Microbial models and salt stress tolerance in plants. Critical Reviews in Plant Sciences 13(2): 121–138.

2. Gaxiola RA et al. 2001. Drought- and salt-tolerant plants result from overexpression of the AVP1 H+-pump. PNAS USA 98: 11444–11449.

3. Gaxiola RA et al. 1998. The yeast CLC chloride channel functions in cation homeostasis. PNAS USA 95: 4046–4050.

4. Gaxiola RA et al. 1999. The Arabidopsis thaliana proton transporters, AtNHX1 and AVP1, can function in cation detoxification in yeast. PNAS USA 96: 1480–1485.

5. Aspe M et al. 1999. Salt tolerance conferred by overexpression of a vacuolar Na+/H+ antiport in Arabidopsis. Science 285: 1256–1258.

6. Drozdowicz YM and Rea PA. 2001. Vacuolar H+ pyrophosphates: From the evolutionary backwaters into the mainstream. TRENDS in Plant Science 6(5): 206–211.

Roberto Gaxiola
Plant Molecular Genetics, Department of Plant Science
University of Connecticut


The strategy of expressing genes simultaneously by linking them in tandem constructs is becoming increasingly popular. However, the complexities of eukaryotic gene regulation present challenges to success. The most notable example is transcriptional interference, which prevents the full expression of downstream genes organized in tandem arrangements through complete or partial silencing. Yajuan Cao and Malla Padidam, at Rohm and Hass in Pennsylvania, have investigated transcription interference and are developing a method for reducing its occurrence.1

Cao's research team used a combined green fluorescent protein (GFP) and luciferase (LUC) system to analyze how gene orientation affects tandem gene transcription interference in tobacco protoplasts. Plasmids were constructed using GFP and LUC genes attached to E35S-TEV (cauliflower mosaic virus—tobacco etch virus) and CsVMV (cassava vein mosaic virus) promoters, respectively. The terminator sequence used for the GFP construct was 35S and for the LUC construct was nopaline synthase.

The two genes were cloned in four head-to-tail orientations:





Either the mammalian transcription blocker (TB) sequence or one of the phage fragments, BstEII, StuI or HindIII, was cloned between the LUC and GFP genes. In addition, an ecdysone receptor-based inducible gene expression plasmid was also constructed to provide chemical inducibility of the LUC gene.

LUC gene expression was affected by the location and the orientation of the adjacent GFP gene. Head-to-tail tandem gene orientation resulted in an 80% reduction in downstream gene expression. Tail-to-tail orientation caused a 53% downstream inhibition. However, head-to-head orientation resulted in no interference. Cao and Padidam also showed that upstream expression of the inducible LUC gene suppressed downstream gene expression by 71%. Neither terminator sequence prevented transcriptional interference between tandem genes.

Transcriptional interference in the LUC (TB) GFP construct was completely blocked by the TB sequence and partially blocked in the GFP (TB) LUC construct. (TB)LUC GFP and LUC (TB) GFP orientations did not affect LUC activity because of the lack of interference found in these constructs. The BstEII and StuI fragments from phage partially negated the interference in the GFP LUC construct; the HindIII fragment not only eliminated interference, it increased LUC expression. The fragments contain between 46% and 63% AT-rich sequences that can act as termination signals, probably causing the elimination of interference noted, according to the authors. The cause of the increased LUC expression seen when constructs contained the HindIII fragment is unexplained.

The strategies for eliminating interference developed by Cao and Padidam are just a few of a growing number of approaches for reducing the problems associated with tandem gene expression in plants (see also: September 2001 ISB New Report, "Bidirectional expression vector for plants," html#sep0103 ). Cao and Padidam illustrate the effects of tandem gene orientation on transcriptional interference and, in other concurrent research, provide evidence of promoter strength as a factor in determining the degree of downstream gene inhibition. These strategies, in addition to the use of transcription inhibitor blockers, increase the approaches that may be used for successfully co-expressing multiple proteins from linked tandem genes in plants.


Padidam M and Cao Y. 2001. Elimination of transcriptional interference between tandem genes in plant cells. BioTechniques 31: 328–334.

Brian R. Shmaefsky
Department of Biology and Environmental Sciences
Kingwood College, Kingwood, TX

Part I: Risks and Hazards

Part II will look at methods to address those hazards

Harm, Risk, and Hazard
A concern related to genetically modified (GM, transgenic) organisms is the potential environmental harm if these organisms escape or are released into the environment. Harm can take many different forms from transient to permanent in time frame and from local to global in scope. Thus, to define harm it is first necessary to distinguish between the terms risk and hazard, which are often confused. In this context, William Muir and Richard Howard (Purdue University, Lafayette, Indiana) define transgene risk as the probability that a transgene will spread into natural populations once released and hazards as the probability of species extinction, displacement, or ecosystem disruption given that the transgene will spread into the population.1 To show lack of harm from transgenic organisms, either the risk [Risk = P(E) where P(E) represents the Probability that Exposure will occur] or hazard [Hazard = P(H/E) where P(H/E) is the conditional Probability of a resulting Harm (H) given that exposure has occurred] must be close to zero; that is, P(E) 0 or P(H/E) 0. Long-term hazards to the ecosystem are difficult to predict because not all non-target organisms may be identified, species can evolve in response to the hazard, and a nearly infinite number of direct and indirect biotic interactions can occur in nature. Muir and Howard conclude the only way to ensure that there is no harm to the environment is to release only those transgenic organisms whose fitness is such that the transgene will not spread, i.e., P(E) 0, in which case the hazard, P(H/E), is irrelevant because the transgene is lost from the population.1

Factors Affecting Risk
In this context, long-term ecological risk can be determined from the probability that an initially rare transgene can spread into the ecosystem. Spread of the transgene into natural populations may result in a number of ways, including 1) vertical gene transfer as a result of matings with feral animals, 2) invasion of new territories as with introduction of an exotic species, and 3) horizontal gene transfer mediated by microbial agents, or a combination of these factors. The relative importance of each factor is dependent on species, transgene inserted, and method used to insert the transgene, respectively.

Vertical Gene Transfer: The first mechanism of spread, vertical gene transfer, is dependent on species modified. Highly domesticated stock developed for poultry, swine, and cattle are not well adapted to the natural setting and may not be able to survive and reproduce there. However, if feral populations are locally available, then local adaptation is not a major barrier to gene spread, as the domesticated GM stock may be able to mate with the highly adapted native populations. Aquatic species present the greatest concern in this regard because aquatic environments are highly connected throughout the world and readily available feral populations exist for all domesticated species. Although feral populations do not exist locally for every domesticated species, if the GM organism has an economic advantage, we must assume that human intervention will transport such organisms to area(s) of the world where native populations exist.

Invasion of New Territories: The second mechanism of spread, invasion of new territories, depends on the functionality of the transgene. The anthropogenic introduction of any exotic organisms into natural communities is a serious ecological concern because exotics could adversely affect communities in many ways, including eliminating populations of other species.2 The release of transgenic organisms into natural environments, however, poses additional ecological risks—although transgenic individuals retain most of the characteristics of their wild-type counterparts, they may also possess some novel advantage. A transgene for enhanced environmental adaptation, such as heat tolerance, would allow cold water fish with this gene to invade cool and warm water environments while maintaining populations in current habitats. As such, GM fish could reproduce at a faster rate; their population may increase unchecked and adversely affect other species. As a consequence, transgenic organisms might threaten the survival of wild-type conspecifics as well as other species in a community.3

Horizontal Gene Transfer: The third mechanism of spread, horizontal gene transfer, occurs naturally through viruses and transposons, but at such low rates that it would not normally be an additional concern. However, if a virus or transposon is used to insert the transgene construct, even if the virus is disabled, it may be possible for the element to recombine with other naturally occurring viruses and spread into new hosts.

Evaluating Risk
Regardless of the mechanism of gene spread, the ultimate fate of the transgene will be determined by the same forces that direct evolution, i.e., natural selection acting on fitness. Thus, risk assessment can be accomplished by determining the outcome of natural selection for increased fitness. This conclusion assumes that the natural populations are large enough to recover from such introductions, i.e., natural selection will have time to readjust the population to its previous state. Fitness in this context is not simply survival to market age but all aspects of the organism that result in spread of the transgene. Muir and Howard reduced these aspects to six net fitness components: juvenile and adult viability, age at sexual maturity, female fecundity, male fertility, and mating success.1,4,5 Mating success is often overlooked because it is not a factor in artificial breeding programs but is often the strongest factor driving natural selection.6

Potential Hazards
Extinction Hazard: Muir and Howard found that pleiotropic effects of transgenes that have antagonistic effects on net fitness components can result in unexpected hazards, such as local extinction of the species containing the transgene.7,1 Such transgenes were referred to as Trojan Genes. A Trojan Gene is a gene that drives a population to extinction during the process of spread as a result of destructive self-reinforcing cycles of natural selection. For example, if a transgene enhances mating success while reducing juvenile viability, the least fit individuals obtain the majority of the matings while the resulting transgenic offspring do not survive as well. The result is a gradual spiraling down of population size until eventually both wild-type and transgenic genotypes become locally extinct.7 These results were later theoretically verified by Hedrick.8 Local extinction of a wild-type population from a transgenic release could have cascading, negative effects on the rest of the community.

The interaction of mating success and juvenile viability is not the only mechanism that can produce a Trojan Gene effect. Muir and Howard have shown that there are other ways in which a Trojan Gene can result, such as if the transgene increases male mating success but reduces daily adult viability, or the transgene increases adult viability but reduces male fertility.1 The latter case is of particular interest because transgenes for disease resistance or stress tolerance can increase offspring viability and transgenes can also reduce male fertility, as has been reported for transgenic tilapia containing the growth hormone (GH) gene.9 Extinction hazards predicted in this case parallel the use of sterile males to eradicate pest insects. However, in the latter program, males are completely sterile and must be reintroduced repeatedly to cause extinction. In effect, the viability of sterile males is near 1.0 (due to repeated introduction) while male fertility is 0%. Such population extinction, as a result of the antagonistic pleiotropic effects of transgenes on viability and fertility, represents a new class of Trojan Genes, which suggests that attempts to reduce transgenic male fertility that do not result in complete male sterility may increase hazard rather than reduce it.9

Invasion Hazard: Muir and Howard also confirmed that, as expected, if any of the net fitness components are improved by the transgene, while having no adverse side effects, the transgene will invade a population.1,4 However they showed that advantages in one fitness component can offset disadvantages in another and still result in an invasion risk. Experimental evidence that transgenes have multiple effects on fitness components was presented by Muir and Howard with the Japanese rice fish, medaka (Oryzias latipes).4 They found that insertion of a growth hormone gene resulted in a 30% reduction in juvenile viability, a 12.5% reduction in age at sexual maturity, and a 29% increase in female fecundity, relative to wild type. Our model predicted that advantages in both age at sexual maturity and fecundity are sufficient to overcome the viability disadvantage produced by the transgene and would present an invasion risk if released. The model also predicted that for a wide range of parameter values, transgenes could spread in populations despite high juvenile viability costs if transgenes also have sufficiently high positive effects on other fitness components.

This research clearly shows that all six net fitness components must be estimated to determine risk. Simple models, such as those presented by Mclean and Laight that are based on viability or other single fitness components, are very misleading.10 Also, those components need to be integrated into a model that combines them into one prediction of risk. In the next part, I (W. M.) will examine experiments to estimate net fitness components and review development of the model.


1. Muir WM and Howard RD. 2001. Environmental risk assessment of transgenic fish with implications for other diploid organisms. Transgene Research. In press.

2. Bright C. 1996. Understanding the threat of biological invasions. In State of the World 1996: A World Watch Institute report on progress toward a sustainable society, ed. L Starke, 95–113. New York: WW Norton.

3. Tiedje JM et al. 1989. The planned introduction of genetically engineered organisms: Ecological considerations and recommendations. Ecology 70: 298–315.

4. Muir WM and Howard RD. 2001. Fitness components and ecological risk of transgenic release: A model using Japanese medaka (Oryzias latipes). American Naturalist 158: 1–16.

5. Muir WM and Howard RD. 2001. Methods to assess ecological risks of transgenic fish releases. In Genetically engineered organisms: Assessing environmental and human health effects, eds. DK Letourneau and BE Burrows, 355–383. CRC Press.

6. Hoekstra HE et al. Strength and tempo of directional selection in the wild. PNAS USA 98: 9157–9160.

7. Muir WM and Howard RD. 1999. Possible ecological risks of transgenic organism release when transgenes affect mating success: Sexual selection and the Trojan Gene hypothesis. PNAS USA 24: 13853–13856.

8. Hedrick PW. 2001. Invasion of transgenes from salmon or other genetically modified organisms into natural populations. Canadian Journal of Fisheries and Aquatic Sciences 58: 841–844.

9. Rahman MA and Maclean N. 1999. Growth performance of transgenic tilapia containing an exogenous piscine growth hormone gene. Aquaculture 173: 333–346.

10. Maclean N and Laight RJ. 2000. Transgenic fish: An evaluation of benefits and risks. Fish and Fisheries 1: 146–172.

William M. Muir
Department of Animal Science
Purdue University


On September 4th, 2001, the Commission of the European Communities released a communication entitled "Towards a Strategic Vision of Life Sciences and Biotechnology: Consultation Document" [COM(2001) 454].1 The 32-page document considers topics such as the potential impacts of life sciences and biotechnology, research agendas, ethics, GMO regulations, and international issues. The paper comes as a result of the EU Commission's intention to formulate, by the end of 2001, a strategic policy on life sciences and biotechnology.

The Commission has asked that comments and contributions from interested groups and the general public be submitted as the first part of a multi-phase consultation process before November 23rd, 2001. Other stages of dialog will follow on the heels of the Commission's paper that will be published at the end of this year.2

As part of the first stage of the consultation process, the Commission organized a pivotal stakeholder meeting in Brussels on the 27th and 28th of September 2001. The event organizers hoped to facilitate a structured dialogue between invited stakeholders on the basis of the September 4th communication, described above. The meeting's primary goal was to help the Commission prepare its policy initiative. However, this meeting was held the same week that the headline "Former GMO rapporteur fears unworkable legislation" ran on the front page of the Rapporteur (the EU Parliament reporter weekly newspaper). The story outlined the serious concerns that David Bowe, a British MEP and former rapporteur for the European Parliament Committee on the Environment, Public Health, and Consumer Policy, holds in relation to the two most recently published proposed regulations for the traceability and labeling of GMOs and products produced from GMOs [COM(2001) 425] and for the regulation of GM food and feed [COM (2001) 182].

The conference brought together stakeholders including: commission officials; technology providers; NGO's; the media; scientific experts; healthcare professions; key groups from non-EU countries such as India, Canada, and the US; and many other interested groups. The two-day event was structured as a workshop. During the first half of day one, an opening plenary session was held, which was chaired by Stanley Crossick, Chairman of the European Policy Centre. Erkki Liikanen, European Commissioner for Enterprise and Information Society
( ), opened the conference. He pointed out that biotechnology is not new and cited genomics as an example of how biotechnology has deepened our understanding of life. He emphasized the importance of the ethics of biotechnology and indicated that consumers must have confidence in the end products of biotechnology. Questions to Commissioner Liikanen ranged from queries on the issues surrounding biological warfare, to ways participants could bring the debate closer to the general public. Commissioner Liikanen responded to the latter concern by advising participants to focus on the Internet as a communication tool.

The panel discussion included Prof. Emilio Muñoz from Madrid, who is an academic researcher dealing with biotechnology issues; Jim Murray, Director of BEUC, a European consumer group based in Brussels; Hugo Schepens, Secretary General of EuropaBio, a biotechnology industry group in Europe; and Risto Volanen, the Director General of the farmers organization COPA-COGECA.

Prof. Muñoz outlined several issues, starting with an examination of the ways life sciences and biotechnology can be made more relative to consumers. He suggested establishing a top-down leadership structure and adding value to products to which consumers relate. He also indicated that technologies such as genomics and alternate energy sources are key biotechnology targets. In reference to agbiotechnology, he highlighted that the area needs political will and indicated the need to increase training from an interdisciplinary perspective.

Jim Murray detailed several concerns from a consumer organization's outlook. Issues surrounding labeling, consumer choice, and clear consumer benefits were discussed. Hugo Schepens welcomed the consultation and outlined industry's position, which has recently applauded the efforts of the Commission to ensure the regulatory process on GM plants comes back on track. He also wanted to see progress on restarting the approval process for GM products in Europe. Risto Volanen promoted the opinions of farmers and stated that farmers have the right to know what they are planting. Questions from the audience focused on a wide range of topics including patents, antibiotic marker genes, segregation problems, lack of consumer choice in Europe, and the difference between information and knowledge.

During the second half of the first day, stakeholders broke into four workshops titled "Potential and Research," "Innovation and Competitiveness," "Public Perception and Ethical Implications," and "Regulation and Governance." The final workshop will be discussed here.

Regulation and Governance Workshop
The chairperson of this session was Laurens Jan Brinkhosrt, Dutch Minister for Agriculture, Environment, and Fisheries. The high-ranking panel members included: David Byrne, EU Commissioner for Health and Consumer Protection: Dorrette Corbey, Member of the European Parliament; Willy de Greef, Syngenta; Eric Liegeois, representative for Annemie Neyts, Minister of State of Foreign Affairs and Minister in charge of Agriculture in Belgium; and Lorenzo Consoli, Media Officer with Greenpeace International.

In his opening remarks, Commissioner Byrne emphasized two points: first, that members of the pro-GM food sector must engage in explaining the benefits of GM food to the public; and second, that the anti-GM food camp should not misrepresent science.

This workshop was split into two discussion sections:
• Regulatory framework
• Governance in the international perspective

Discussion of the Regulatory Framework
There was considerable focus on both the new directive 01/18/EC and the EU Commission's recent proposals for the traceability and labeling of GMOs and derived products and for the regulation of GM food and feed. There was broad agreement on four main issues: that GM seeds, food, and feed should be authorized only after they have been found to be safe for human and animal health and the environment; that such decisions should be based on a full and complete science-based assessment; that scientists involved in the risk assessment procedure must be independent; and that a high degree of transparency and public information be ensured. It was made clear that the new European Food Authority will play an important role in maintaining an independent and fair risk assessment process.

Debate occurred on several points, one of which was the proposal for labeling products derived from genetic modification, irrespective of whether or not they contained traces of transgenic DNA or protein. Commissioner Byrne maintained labeling was necessary to allow consumer choice. However, several people raised the point that, in reality, the market retailers would simply not stock such products, or label everything, and hence European consumers would still have no real choice. Commissioner Byrne felt this was a "market decision," and neither he nor the EU could do anything about it.

Also debated was whether the benefits of GM foods for society should be taken into account during the authorization procedure. Commissioner Byrne suggested that such benefits were not a matter for risk assessors or risk managers and their merits should be left to the public and the market to assess.

Mr. Consoli, from Greenpeace, raised the issue of the problems he foresees with the 1% threshold for adventitious contamination from unauthorized seed varieties, which is outlined in the Commission's new proposals. He also pointed out the lack of an adequate liability regime and discussed the patentability of biotechnological inventions.

Discussion of Governance in the International Perspective
Participants at this section of the meeting raised several important issues concerning the governance of biotechnology and discussed how EU regulations fit within the international sphere. It was suggested that the Commission take more initiatives in public information and actively involve the public in debates. Mrs. Corbey called for the "democratization of knowledge" within the public arena.

The concept of a multifunctional agricultural system for Europe was underlined and given broad support. To this effect, the need to safeguard the co-existence of organic, conventional, and GM farming methods was recognized. International efforts to focus more research toward helping developing countries were deemed essential. The participants conceded that the Biosafety Protocol provided a good framework for international harmonization; however, there were some concerns about its wider ratification and how realistic the agreement was on an operational level.

The following morning, EU Commissioner for Agriculture, Franz Fischler, spoke as part of the concluding plenary session. He indicated the need to actively shape biotechnology policy and expressed his desire to take a proactive stance. He also stressed that agbiotech research in the EU should proceed in order to remain competitive internationally and indicated the negative consequences that would result if the EU turns its back on biotechnology. He reviewed the main points of the new regulation proposals recently published by the Commission and outlined the basis for appropriate regulations for food safety. During the question-answer period, Fischler acknowledged that many risks to food safety are greater in conventionally derived products (namely from E. coli 0157:H7 and Salmonella) than from GM food. He was also adamant that since the public has perceived the `organic' food label to also mean `GM-free', that distinction should be maintained.

The Commission has now started a consultation process. Consultations will commence prior to drafting its new proposals on biotechnology and continue after publishing its proposals at the end of 2001. It is clear that the current proposed regulations on traceability and labeling face several challenges, some technical in nature, while others are political (or even biopolitical). The technical issues are numerous, but the most serious one is the task of establishing and enforcing labeling standards for GM-derived food products that do not contain residual transgenic DNA or protein. The political issues relate to the splitting of the recent regulation proposal into two reports to be dealt with within two different streams, which is likely to complicate the issues. Newspaper Rapporteur, David Bowe, an experienced EU legislator on the topic of GMOs, stated, "I am concerned that we will find ourselves with two different approaches and two different directions."

Mr. Bowe also pointed out that deliberations on the two separate proposals could likely take place on two very different time scales, which will create serious difficulties in trying to keep the proposals mutually coherent. Added to this complication are the recent reports that the European Parliament Committee on the Environment, Public Health, and Consumer Policy (where one of the proposals will be discussed) has raised complaints that the Committee's workload is becoming too great.


1. COM(2001) 454. September 4, 2001. "Towards a Strategic Vision of Life Sciences and Biotechnology." Communication from the Commission. Commission of the European Communities. Brussels.
< >

2. EUROPA: European Commission: Biotechnology. < >

Shane Morris
Centre for Safe Food
University of Guelph

More meetings can be found at

Assessment of the Allergenic Potential of Genetically Modified Foods
December 10–12, 2001
Sheraton Hotel, Chapel Hill, NC

RESCHEDULED: Originally scheduled for September 24–26, 2001.

Organized by the National Institute of Environmental Health Sciences, National Toxicology Program, at Research Triangle Park, NC, this meeting will gather experts in food allergy, GM crops and the regulatory aspects of these products, along with bench scientists and clinicians, to examine the current state of knowledge in the area, identify the critical issues regarding these materials, and develop testing strategies to examine the allergenicity of these compounds. In addition to the speakers and invited participants, the public is invited to attend the workshop as observers. The number of observers will be limited only by the available space. An open discussion session is scheduled each day to provide an opportunity for observers to contribute to the scientific discussion.

The meeting is sponsored by: US Environmental Protection Agency; Department of Health and Human Services; National Institutes of Health; and the US Food and Drug Administration.

Ms. Angie Sanders
Tel: 919-541-0530
Fax: 919-541-0295

Plant, Animal and Microbe Genomes X Conference
January 12–16, 2002
San Diego, California

PAG X will bring together the leading genetic scientists and researchers involved in plant, animal and microbe research and related areas. With over 25 countries represented, the Plant, Animal and Microbe Genomes Conference provides an established forum for the exchange of information internationally as well as domestically. A partial list of general session topics includes:

• Technology
• Organization and Recombination
• QTL's, Mutants and Candidate Genes
• Comparative Genomics

New workshops have been added this year including Edible Legumes, Organellar genetics, Plant Alien Introgression, Plant Transgene Genetics, Grape Genome, Connectrons, and Plant Transformation. There will also be some 64 workshop and vendor presentations (an increase of about 10 from the last conference), as well as the usual computer program demonstrations.

Sponsors include:
USDA; The Rockfeller Foundation; International Society for Plant Molecular Biology (ISPMB); Johns Innes Centre; The American Society for Horticultural Science; NCGR - National Center for Genome Resources; BIO - Biotechnology Industry Organization.

Contact for administrative questions:
Darrin Scherago
Tel: 212-643-1750 (ext. 20)
Fax: 212-643-1758

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