New Genetics, Food & Agriculture: Scientific Discoveries - Societal Dilemmas

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Key Documents
Areas of Convergence
     Table 5.1 Comparison of food safety regulations for genetic alterations of food crops
      Table 5.2 Typical information required- assessment of environmental release of GM plants
Areas of Divergence
Gaps in Knowledge
Towards Coexistence of Different Agricultural Systems  
      Table 5.3 Frequency of gene flow from out crossing in selected crops in Europe
Risks of Regulation
Risks of Regulation
International Harmonization of Regulations  

Note: For all references cited within this chapter, direct links are provided to the appropriate section of the Annotated Bibliography

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Key Documents

A recent review by Nap et al (2003) in the online publication, The Plant Journal, gives an excellent overview of the current regulatory approaches worldwide.  Several recent national reviews were charged with advising governments on ways to improve their national regulatory systems (eg Australia, 2000; The Royal Society of Canada, 2001; Canadian Biotechnology Advisory Committee, 2001, 2002; New Zealand, 2001; The Royal Society, UK, 2002; National Academy of Sciences, USA, 2000, 2002). Other international and inter-governmental agencies are concerned with promoting regulatory harmonization, regionally (e.g. EC 2001; 2002) and internationally (e.g. FAO/WHO 2000, 2001a,b; OECD 2000b; OECD 2001a,b). 

There are several issues relating to the persistence of transgenic fish in the environment and the effects they may have on wild fish populations. These need to be resolved before any transgenic fish can be released into the environment (Pew 2003).  

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Areas of Convergence

Principles: There is broad agreement that regulatory systems need to be science-based, transparent, and involve community participation, and that safety assessments should be undertaken on a case-by-case basis, using the best available scientific techniques. 

Regulatory processes also need to be sufficiently flexible and robust so as to be able to detect early warning of changing circumstances. Recent instances of food safety problems in several countries highlight the need for continuing vigilance in ensuring that foods brought to market are safe to eat, irrespective of their source and production methods. These foods may come from conventional or subsistence agriculture, organic agriculture and/or the cultivation of GM foods and crops.

Regulatory systems for the applications of modern genetics in food and agriculture are based broadly on assessing the safety for human health and the environment of either the product or the process by which it is produced, or a combination of the two approaches.

A comparison of the food safety regulations for genetic alteration of food crops in selected countries is shown in Table 5.1.    

Similarity of data sets:  Different regulatory systems base their assessments on similar sets of data requirements concerning the organism, insert, trait and environment. Though there is variability between the details of risk assessments, the issues that they address are common across many countries (OECD 2001b).  

For plants, produced with the aid of gene technology, the type of information sought by regulators for making their risk assessments prior to environmental release is similar, whether the regulatory approach is product based or process based (Table 5.2).

Biosafety framework: The Cartagena Protocol on Biosafety lays down a methodology for risk/safety analysis including a number of systematic steps and a list of points to consider in relation to the possible impact of living modified organisms (LMOs) on biodiversity.  A current project financed by the Global Environment Facility, and implemented primarily through the United Nations Environment Program (UNEP) is assisting many countries in implementing biosafety systems that conform to the requirements of the Cartegena Protocol of the Convention on Biological Diversity (CBD) (ISNAR 2002a). 

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Table  5.1:  Comparison of food safety regulations for genetic alterations of food crops

		Gene alterations a
		Insertion of genes (general)	Insertion of genes coding for previously approved gene products	Insertion of genes from same plant species (self-cloning)	Cross between approved transgenic lines	Mutation breeding and somaclonal variation (non GM)
Australia b	ANZFA Food Standard A18	+	–	+	– c	–
Canada d	Food and Drug Act	+	+	+	(+)	+
EU e	Regulation 258/97/EC	+	+	+	+	(+)
Japan f	Food Sanitation Law	+	+	–	+	–
New Zealand b	ANZFA Food Standard A18	+	–	+	– g	–
USA h	FFDCA	+	–	(+)	(+)	(+)

a +, To be evaluated; (+), should be evaluated unless substantially equivalent; –, evaluation not required.
b ANZFA, Australia-New Zealand Food Authority: ANZFA (1998).
c Notification required: OGTR (2001).
d Health Canada (1994).
e EU (1997a); EU (1997b); EU (1990).
f MHW (2001).
g The New Zealand Hazardous Substances and New Organisms Act 1996 does not specifically provide for the breeding of approved genetically modified plant lines; however, the Australian Gene Technology Act 2000 does allow for this as "dealings" with GMOs: Australia (2000); New Zealand (1996).
h FFDCA, Federal Food, Drug, and Cosmetic Act: FDA (1992); Maryanski (1995).

Source: Kuiper et al (2001)

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Table 5.2.  Typical information required for assessment of environmental release of GM plants#.

General information
1. The name and address of the applicant
2. The title of the project
Information relating to the parental organism
3. The full name of the plant: family, genus, species, subspecies, cultivar
4. Information on the reproduction of the plant: mode, generation time and sexual compatibility with other cultivated or wild plant species
5. Information on the survivability of the plant: survival structures, dormancy etc
6. Information concerning dissemination of plant: means, extent and factors affecting dissemination
7. The geographic distribution of the plant
8. If the plant species is not normally grown in Member States, describe the natural habitat
9. Information on any significant interactions of the plant with organisms other than plants in the ecosystem where it is usually grown, including toxicity to humans, animals and other organisms
Information relating to the genetic modification
10. A description of methods used for genetic modification
11. The nature and source of the vector used
12. The size, function and donor organism(s) of each DNA sequence intended for insertion
Information relating to the genetically modified plant
13. A description of the trait(s) and characteristics of the GM plant which have been modified
14. Information on sequences inserted or deleted: size/structure, copy number of insert, information on any vector sequences or foreign DNA remaining in the GM plant. The size/function of any deleted regions. Cellular location of insertion (eg. chromosomal, mitochondria, chloroplast etc.)
15. Information on the expression of the insert: expression and parts of the plant where expressed
16. How does the GM plant differ from the recipient plant in mode/rate of reproduction, dissemination, survivability
17. The genetic stability of the insert
18. The potential for transfer of genetic material from the GM plants to other organisms
19. Information on any toxic/harmful effects on human health and the environment arising from the genetic modification
20. The mechanism of interaction between the GM plants and target organisms
21. Any potential significant interactions with non-target organisms
22. A description of detection and identification techniques for the genetically modified plants
23. Information about previous releases of the GM plants
Information relating to the site of release
24. The location and size of the release site or sites
25. A description of the release site ecosystem, including climate, flora and fauna
26. Details of any sexually compatible wild relatives or cultivated plants present at the release sites
27. The proximity of the release sites to officially recognised biotopes or protected areas
Information relating to the release
28. The purpose of the release
29. The foreseen dates and duration of the release
30. The method by which the GM plants will be released
31. The method for preparing and managing the release site, prior to, during, and after the release
32. The approximate number of GM plants (or plants per m2) to be released
Information on the control, monitoring, post-release plans and waste treatment plans
33. A description of any precautions to minimise or prevent pollen or seed dispersal from the GM plant
34. A description of the methods for post-release treatment of the site or sites
35. A description of post-release treatment methods for the GM plant material including wastes
36. A description of monitoring plans and techniques
37. A description of any emergency plans
Information on potential environmental impact of the release of the genetically modified plants
38. The likelihood of any GM plant becoming more persistent or invasive than recipient plants
39. Any selective advantage or disadvantage conferred to other sexually compatible plant species, which may result from genetic transfer from the genetically modified plant
40. Potential environmental impact of the interaction between the GM plant and target organisms
41. Any possible environmental impact resulting from potential interactions with non-target organisms

#Prescribed questions from Schedule 1 of the 1995 Regulations for the Deliberate Release of GM Higher Plants of the UK.  
Source: Nap et al,2003.

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Areas of Divergence

Although the data sought by regulators is similar, their interpretation in risk assessment and management differs amongst countries and regions.  The substantive differences come as to the level of risk regulators consider will be acceptable for a given society. Since biological systems do not deliver certainty, zero risk for any new technology is an unattainable standard. 

Managing uncertainty:  There remains a difference of view in how to cope with uncertainty in risk assessments. One approach is where risk management might be applied in advance of assessment, so that risks which, based on current scientific knowledge, could not be assessed rationally are simply avoided. A number of countries apply such a precautionary approach. Others believe that it is not possible to manage risks that cannot be assessed rationally and that governments should focus on assessing and managing identifiable risks (OECD 2001b).

Extent of risk assessments required:  Other regulators consider that the extent of risk assessments should be proportionate to the degree of risk involved, and that this can be determined when the new product/process is compared with its conventional counterpart with which there is some familiarity.  This approach of regulating the product, and assessing its degree of familiarity or difference with present products is the basis of the regulatory system in the USA. 

Comparative risk assessments:  Other issues that remain under debate are whether assessment of risk and uncertainty should be applied primarily to new technologies or should also be applied to conventional agricultural practices (OECD 2001b; US NAS 2002).  Others consider that both the risks and benefits of new technologies need to be considered, in comparison with present agricultural practices.

Hazard identification:  While the likelihood of harm is a function of both hazard and exposure, the public debate is dominated by hazard identification, often neglecting issues such as exposure and the likelihood of harm, an evaluation of the final consequence and a comparison with the present situation. The coverage of potential harm to the Monarch butterfly by Bt maize is an example of this focus on hazard identification (Pew 2002; Shelton and Sears 2001).  

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Gaps in Knowledge

Most regulatory systems agree on the need to continually improve risk assessment methods, making use of new scientific developments, so they keep abreast of emerging products and processes. Regulatory systems also need to be sufficiently flexible so as to respond to accumulating experience in the behaviour of new products once they are in widespread use.

Improving food safety assessments: There is a need for continued development of food safety assessments methods, so as to assess the safety of future products that may be the result of more complex genetic modifications (e.g. foods with modifications to their nutrient content).  For example, new scientific developments in areas such as metabolomics and proteomics may enable the content of whole foods to be assessed, thus improving on the present concept of substantial equivalence whereby a limited number of targetted compounds are compared between the new product and its conventional counterpart food. These scientific developments will also enable better monitoring of any unintended changes in the content of foods that may result from genetic modification. Such changes may occur either by conventional breeding or gene technology.

Improving environmental assessments: One of the areas where there is most debate is on the methods used to assess environmental impact, and on what constitutes an adverse environmental impact. One approach is to compare GMOs with organisms produced using more traditional breeding techniques. Some of the outstanding issues in assessing environmental impacts are the lack of reliable base line data, the relevance of extrapolation from small to large scale use, and from the laboratory to the field, ability to detect rare events within a relatively short experimental time scale, lags between introduction and manifestation of environmental impacts and the lack of knowledge about the complexity of ecosystems, including soil ecosystems. Assessment of the impacts of GMOs on non-target organisms needs to reflect the complexity of different environments, and the need for comparison with other agricultural practices. 

Centre of diversity data:  Risk assessments of genetically modified crops have focused mainly on agronomic characteristics in temperate regions. Comparative risks and benefits of the introduction of LMOs with alternative cultivation methods need to be assessed on a case by case basis, taking into account regional agricultural practices and, where appropriate, socio-economic considerations. Baseline data required for environmental impact assessment, including information on native species and existence of sexually compatible wild relatives of agricultural crop plants are limited in centres of crop diversity (OECD 2001b).

Ecological experimentation: In ecological impact assessments, it is difficult to extrapolate from small-scale field trials to commercial scale cultivation. Countries have taken a number of approaches to dealing with this issue. In the UK, the approach has been to hold farm scale field trials that address scale, and integrate regional cultivation practices and farmer behavioural issues. The cost of these issue-targeted farm scale field trials may be prohibitive for routine assessments of impacts of individual LMOs. Regulatory requirements may impose a cost barrier for development of minor crops or those important in the developing world.

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Towards Coexistence of Different Agricultural Systems

One of the future challenges is devising ways and means, including standards, for different forms of agriculture to be able to live together in areas of multiple land use. This is particularly challenging for farmers practising broad scale agriculture and/or organic agriculture. For example, research commissioned by the EC over the past 15 years is giving guidance to ways to minimise gene flow from crop to crop and from crops to wide relatives (Eastham and Sweet, EEA 2001).  Different crop species have different rates of autogamy (self pollination) and out-crossing. In addition, some crops have hybridising wild relatives in Europe while others do not. The characteristics of the main crop types crops when cultivated in Europe are summarized in Table 5.3. 

 

Table 5.3. Frequency of gene flow from out crossing in selected crops in Europe.

Crop	Frequency of gene flow from outcrossing
	Crop to crop	To wild relatives
Oilseed rape	High	High
Sugar beet	Medium to high	Medium to high
Maize	Medium to high	No known Wild Relatives
Potatoes	Low	Low
Wheat	Low	Low
Barley	Low	Low
Fruits – strawberry, apple, grapevines and plums	Medium to high	Medium to high
Raspberries, blackberries, blackcurrant	Medium to high	Medium to high

Source: Eastham and Sweet, EEA, 2002  

Unintended gene flow can be minimised by spatial and temporal barriers (with guidance as to the necessary distance between crops); by selecting crops with low risks of gene flow outside the crop, either because they are not outcrossing species, or there are no related or wild species in the vicinity; and/or by targeting gene expression to certain parts of plants (eg leaves) and having no target gene expression in pollen. 

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Risks of Regulation

Regulation can itself be a risk and a benefit for new technology development. The products of modern genetics in agriculture are regulated more stringently than their counterparts coming from traditional breeding programs or the products of other production systems such as organic agriculture.  

The cost, complexity and uncertainty of regulation in new genetics is making regulatory requirements one of the barriers to entry for public research institutes, poor countries and small companies. This has long been the case in the pharmaceutical and agro-chemical sector. It is becoming the case in the seed sector as well.  This is increasing the trend for future investments to concentrate on those products with likely commercial value where the costs of regulation will be built into the price of the product. Less investment will be available for generating public goods, including those of possible value in emerging economies.  Biosafety regulatory requirements are limiting the choices for the use of new genetics to improve agriculture in emerging economies.

However, there remains a lack of public confidence in the regulatory systems in some countries and this is one of the drivers behind the increasing stringency of regulation. This raises the issue of what more needs to be done to improve public confidence in the regulatory and post-approval stages of the release of genetically modified organisms into the environment.

Further science based case studies that compare the risks, benefits and regulation of crops developed through new genetic technologies with similar crops cultivated under intensive agricultural practices and/or organic agricultural practices, would be useful to illustrate the relative merits of different approaches and various scenarios.     

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International Harmonization of Regulations

Setting standards and regulatory harmonization:  The FAO/WHO sponsored intergovernmental commission, Codex Alimentarius, is playing an important role in setting internationally agreed guidelines and standards for the safety of genetically modified foods for human consumption (FAO/WHO 2000, 2001a,b). No comparable internationally agreed guidelines and standards exist for evaluating the environmental safety of living (genetically) modified organisms.  The Cartegena Protocol of the Convention on Biological Diversity (CBD) provides an inter-governmental forum amongst the parties to the Convention for assessing the impacts of living modified organisms (LMOs) on biodiversity, one component of the environment. A broader forum is needed to enable the development of internationally agreed standards for comprehensive environmental impact assessments of the risks and benefits of new genetics in agriculture.  FAO, UNEP and other international agencies could play an important convening role here, supported by the scientific community, in developing internationally agreed guidelines and standards for the assessing the environmental impact of living modified organisms.

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