INTERNATIONAL
INSTRUMENTS FOR THE RESPONSIBLE USE OF
GENETICALLY MODIFIED
AQUATIC ORGANISMS

Devin M. Bartley

Fishery Resources Division

 

"Doubtless God could have made a better berry, but doubtless God never did."

Now humans can make a better berry !

 

Mr. Isaak Walton in his classic book on fishing (The Compleat Angler, 1593 – 1683) attributes the above quote to a Dr. Boteler who was very fond of strawberries. We now have the technology to make a better berry - the anti-freeze protein gene from the winter flounder has been inserted into strawberries and other crops to help them tolerate cold temperatures. Is this a "better" berry? What are the benefits and risks? Will genetic modification be useful and accepted in aquaculture? When and for whom? International organizations must address a variety of questions in this area. The following article is based on a presentation the author made at WAS 1999.

Introduction

Genetic modification of aquatic species has the potential to increase greatly both the quantity and quality of products from aquaculture. Traditional animal breeding, chromosome-set manipulation, and hybridization have already made significant contributions to aquaculture production, and their contribution is expected to increase as aquatic species become more domes-ticated and as breeding and

genetic technology continue to improve. Experimental and pilot projects on transgenic organisms have demonstrated that growth rate can be improved dramatically (Figure 1); other commercially important traits can be improved as well. Although no transgenic aquatic species are available to the consumer at present, some feel that transgenic fish will be on the market within the next few years.

However, there is a concern in aquaculture, as in other food producing sectors, that transgenic technology poses risks and therefore must be carefully monitored and regulated to ensure that environmental and human health are not endangered. Consequently, international legislation, guidelines, and codes of conduct have been, or are being, established to address these issues.

Exactly what a genetically modified organism(GMO) is, appears difficult to define (see Box 1).

International instruments, some legally binding and others voluntary, cover a broad range of issues associated with GMOs in aquaculture: -the introduction (transboundary movements) and release into the environment,
-international trade, -human health, -labelling, -intellectual property rights, -and ethics.

 

Box 1. Nomenclature

Q: When is an organism whose genetic structure has been modified, not a genetically modified organism?

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A: When people may eat them.

A common nomenclature will be crucial in establishing legislation and policy for the responsible use of genetically

modification of genes and their introduction into living cells or viruses of DNA as well as techniques for the production involving cells with new combinations of genetic material by the

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modified organisms. However, this is proving to be a formidable task. The Fourth meeting of the International Association of Geneticists in Aquaculture refused to draft a technical

fusion of two or morecells" (ICES 1995).

USDA states that their Performance Standards on conducting research on GMOs apply to the following organisms:

CBD (GMOs have become LMOs in the language of the CBD) - "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the

definition (pers. ob.); the CBD is still trying to develop a definition of LMO. The tendency in international legal bodies and industry is to restrict GMOs to transgenics, whereas some voluntary instruments adopt a wider definition that includes other genetic modifications such as hybridization, chromosome manipulations, sex reversal, and selective breeding. Some definitions of GMOs follow:

ICES - "An organism in which the genetic material has been altered anthropogenically by means of gene or cell technologies. Such technologies include isolation, characterization , and

1. "Deliberate Gene Changes – including changes in genes, transposable elements, non-coding DNA (including regulatory sequences), synthetic DNA sequences, and mitochondrial DNA;

2. Deliberate Chromosome Manipulations – including manipulation of chromosome numbers and chromosome fragments; and

3. Deliberate Interspecific Hybidization (except for non-applicable species discussed below) –referring to human induced hybridization between taxonomically distinct species". To

use of modern biotechnology. "Living organism" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids. "Modern bio-technology" means the application of:

(i) In vitro nucleic acid techniques, including recombinant DNA and direct injection of nucleic acid into cells or organelles, (ii) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.

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clarify further, the USDA states thatnon-applicable organisms are intraspecific selectively bred species, and widespread and well known interspecific hybrids that don’t cause adverse ecological effects.

EU An organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination" (EEC1990).

. .

   "Genetically modified micro-organisms are organisms in which genetic material has been purposely altered through genetic engineering in a way that does not occur naturally."

 

The purpose of this note is to describe briefly the main instruments that deal with the use of GMOs and their implications for aquaculture development. Much of what is presented below comes from the plant sector, but aquaculture may expect similar processes, opportunities and problems in the further development of aquatic GMOs. It will be prudent to follow what is going on in the crop and livestock sectors.

Import and release into the environment

The import of a GMO and its release into the environment is covered by sections of the European Community Directives, UN Recommendations on the Transport of Dangerous Goods (1995), the Convention on Biological Diversity (CBD), the FAO Code of Conduct for Responsible Fisheries (CCRF), and the International Council for the Exploration of the Sea (ICES). The risks discussed in this section pertain mainly to those to the environment (human health issues are discussed below).

Common elements of the legislation or guidelines include; licensing for field trials on and release of GMOs, notification that a GMO is being exported/imported and released (also known as "advanced informed agreement") and an environmental impact assessment. Members of the EU were supposed to incorporate uniform licensing procedures for testing and sale of GMOs in national legislation; if a GMO was licensed in one country, field testing, release and sale should be allowed in the other countries as well. However, genetically modified (gm) maize which was approved in France, was not adopted in Austria and Luxembourg and when the government changed in France, so did the approval for commercial releases of gm maize.

EC Directive 94/15/EC/ of 15 April, 1994, adapting to technical progress for the first time Council Directive 90/220/EEC/ on the deliberate release in the environment of genetically

poisson.jpg (68965 byte)

 

Figure 1. Transgenic chinook salmon from New Zealand King Salmon Company's land-based research facility. The top 3 fish are transgenics, 11 months old with an average weight of 850g, whereas the bottom fish is their non-transgenic sibling of the same age, weight 280g. Photo by Seumas Walker.

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modified organisms, requires notification that a GMO is to be released. The directive also lists requirements for impact assessment, control and risk assessment. It is interesting to note that notification requirements are different for higher plants and other organisms and that release includes placement on the market.

The CBD, which has the largest number of Parties of any international instrument at 175, calls for the establishment of "means to regulate, manage or control the risks associated with the use and release of LMOs ... which are likely to have adverse environmental impacts …" (Article 8g). In addition, it calls for legislative, policy or administrative measures to support bio-technological research, especially in those countries that provide genetic resources (Article 19). Furthermore, Article 19 (3) directs Parties to consider the need and modalities for internationally binding protocols on the safe transfer, handling and use of LMOs that may have adverse effect on the conservation and sustainable

use of biological diversity. The negotiation of these protocols is currently underway (http://www.biodiv.org/biosafe/).*

Article 9.3 of the CCRF addresses the "Use of aquatic genetic resources for the purposes of aquaculture including culture-based fisheries". This article calls for:

- conservation of genetic diversity and ecosystem integrity;

- minimization of the risks from non-native species and genetically altered stocks;

- creation and implementation of relevant codes of practice and procedures, and

- adoption of "appropriate" practices in the genetic improvement and selection of broodstock and their progeny.

 

Article 9.2.3 advises, " States should consult with their neighbouring States, as appropriate, before introducing non-indigenous species into transboundary aquatic eco-systems", and the FAO Technical Guidelines on Aquaculture Development states, "Consultation on the introduction of genetically modified organisms should also be pursued. The definition of ‘non-indigenous’, in broadest sense of the term, should include organisms that are the product of domestication, selective breeding, chromosome manipulation, hybridization, sex-reversal, and gene transfer".

ICES1  has added a section on GMOs to its guidelines for species introductions. Thus, GMOs are acknowledged to be a form of non-native species; in many international fora, alien species and alien genotypes are terms used to signify organisms that do not naturally occur in a given area. Like the CCRF, the ICES protocols are voluntary, but they have been adopted in principle by numerous regional fishery bodies, by the International Network for Genetics in Aquaculture (ICLARM secretariat), and by national governments such as the Philippines.

Aquaculturists contemplating the use of GMOs should be aware of and follow notification and assessment requirements. Even when not required by law, such practices are prudent and will help promote an image of responsibility.

Trade

Trade issues are extremely complex, politically charged, and cover a variety of components, such as patenting and labelling requirements. The main instrument governing international trade is the World Trade Organization, created in 1995 following the Uraguay Round of trade negotiations. With 134 Member Countries, it is the body responsible for administering international trade and resolving disputes for most of the world’s trading nations. The Center for International Environmental Law

(CIEL) noted that due to the "interlocking relationships between trade and other issues, including environmental protection, WTO activities now have more extensive ramifications." (CIEL 1999 -http://www.igc.apc.org/ciel/shmptur.html). The purpose of the WTO is to promote trade liberalization that includes non-discrimination, and ensuring that the conditions for trade are stable, predictable and transparent. Components of the WTO in relation to GMOs are the removal of trade barriers, the requirements for intellectual property protection, e.g. patenting, and labelling requirements.

Intellectual property rights

WTO set up the first global system for intellectual property rights (IPR) on biological diversity, with specific reference to plants, to protect the inventors and developers of a product and to foster innovation. The relevant section of WTO is the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that requires Members to form intellectual property rights

 

on, inter alia, certain food and living organisms. TRIPS Article 27(3)(b) allows for the patenting of life forms, and requires that systems for IPR be developed by 2000 in developing countries and by 2005 in least-developed countries. Article 27 of TRIPS says the inventions it recognizes must meet the criteria of novelty, inventiveness (non-obvious) and industrial applicability (use-fulness). TRIPS countries have discretion on whether to protect plants or animals with patents or sui generis system and whether to recognize such patents.

DG XII of the European Commission has nearly similar requirements for IPR, except that the EC states that "plant and animal varieties and essentially biological processes for the production of plants or animals, including crossing or selection, are not patentable". Biotechnological inventions now are better protected in the EU due to common rules for patent law as set out in the new Directive 98/44/EC (http://europa.eu.int/>http://europa.eu.int/). But neither plant and animal species nor biological processes for their production are covered by the legislation as they are essentially biological and not

Box 2. Different perspectives on patenting in fish vs plants

The patenting process is supposed, inter alia, to promote innovation. Monsanto has recently sought patents on a genetic modification that renders seeds nonviable when a specific chemical that activates a series of genes is sprayed on them. The general name for this process is Genetic Use Restriction Technologies and it helps companies like Monsanto protect their product (genetically improved seeds) from being used without permission on compensation to Monsanto. Because many farmers in developing areas need to save seeds for the next season, this particular technology was embroiled in controversy and seen by many to be a threat to world food security. The technology was given the emotive name of Terminator Technology and the outcry against such a practice was so strong that Monsanto has said it will not commercialize the technology.

However, such a genetic modification might be extremely advantageous for farmed fish. Through the patenting process and the disclosure of the genetic manipulations involved, we now have a model for gene activation and deactivation that may be used in other sectors, such as aquaculture. Modifying an exotic farmed fish or shellfish so that it could not reproduce in the wild would help reduce many of the environmental concerns facing aquaculture today. This is not to be seen as an endorsement for GMOs, but rather another perspective on the patenting issue.

 

biotechnological processes. For ethical reasons, the directive bans patenting of human cloning, the use of human embryos for industrial or commercial purposes, the manipulation of human genetic identity as well as the discovery of natural substances.

Patenting and intellectual property protection are so complicated that international instruments dealing with the issue are in conflict. The WTO and the USA allow patenting of living organisms whereas the EC does not (http://www.uspto.gov/
web/offices/pac/doc/general/what.htm). Aquaculturists should be aware of the potential controversies associated with patenting GMOs and how this may affect marketing, property rights, and trade in certain areas.

Human health and food quality

For the consumer of gm products, human health is probably the most important issue. Here there is a tremendous lack of knowledge and understanding. People who regularly consume the enzyme chymosin from gm bacteria in their parmesan cheese (the natural source is from calf stomach), or probably have no objection to genetically engineered insulin for diabetes, state they would never eat a gm fish nor let their children eat one. There are health concerns and these must be addressed in a reasonable manner (see also section on ethics below). Internationally, it is the EU and the Codex Alimentarius Commission (CAC) that take the lead roles.

CAC was formed as an inter-governmental body by FAO and the World Health Organisation; its current membership is 163 countries. The scope of Codex Standards includes all food safety considerations, description of essential food hygiene and quality characteristics, labelling, methods of analysis and sampling, and systems for inspection and certification. Codex standards, guidelines and other recom-mendations are not binding on Member States, but are a point of reference in international law

(General Assembly Resolution 39/248; Agreement on the Application of Sanitary and Phytosanitary Measures; Agreement on Technical Barriers to Trade). At present, risk analysis is considered to be an integral part of the decision-making process of Codex.

At its most recent 23rd Session (July 1999), the CAC established an Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology with the objective of developing standards, guidelines or recommendations for foods derived from biotechnology or traits introduced into food by biotechnology, on the basis of scientific evidence, risk analysis and having regard to other legitimate factors relevant to the health of consumers and the promotion of fair trade practices.

The Commission also preliminarily adopted an amendment to the General Standard for the Labelling of Prepackaged Foods as related to the labelling of foods obtained through biotechnology dealing with foods substantially different from usual foods. The general issue of the labelling of other foods is still under discussion (see below).

The 1997 EU Novel Foods and Novel Food Ingredients Regulation 258/97 forces mandatory pre-market approval for all foods without a history of consumption in the EU. For "substantial equivalent" foods simple notification is all that is required (fast track procedure).

Labelling

Labelling of GMOs or products from GMOs is also an extremely contentious issue as exemplified by the current trade conflicts between Europe and the US over labelling of genetically modified crops such as corn and soybeans. Some think that thinks labelling is impractical and would be ambiguous in any case (Williams 19982 ), whereas Europe believes that it is necessary for informed consumer choice and to prevent a public relations disaster.

A major concept in labelling is that of "substantially equivalent" which

Canada there means that if the GMO or product is equivalent to the non-GMO counterpart then no extra legislation or oversight is needed. In 1997 the EU Novel Foods Regulation made labelling of gm food, or food obtained from GMOs mandatory if they were not substantially equivalent to existing products. Further, recognition must be given to mixtures of gm and non-gm crops (e.g. US soybeans).

The CAC document, Proposed Draft Recommendations For The Labelling Of Foods Obtained Through Biotechnology states, "When a food produced by biotechnology is not substantially equivalent to any existing food in the food supply and no conventional comparator exists, the labelling shall indicate clearly the nature of the product, its nutritional composition, its intended use and any other essential characteristic necessary to provide a clear description of the product". However, there was no justification in terms of food safety for specific labelling of foods that were substantially equivalent to conventional foods, as there was no evidence of any specific health hazards. The labelling of GMOs in food is still a controversial subject with which the Codex Commission is currently dealing.

Labels can be an effective market force as in the example of "dolphin friendly tuna" and "organic something". However, how much information should go onto a label and the authenticity of labels will be difficult matters to resolve.

In many developed countries, products with "organic farming" labels or certifications are becoming popular and fill a specific market niche where consumers will pay a premium price for such products. The International Federation of Organic Agriculture Movements (IFOAM) has produced standards required for their certification3. For organic certification, vaccines are allowed, but genetically engineered vaccines are not; feeds may not contain GMOs nor their products; triploids and genetically engineered species or breeds are also not allowed.

 

Although no gm fish or shellfish are now on the market, fish meal may contain genetically modified soy beans; the EU and Japan are requiring labelling on this feed. According to reports on an internet discussion group on shrimp(shrimp-owner@onelist.com) or http://www.onelist.com, the feed industry is looking carefully at reactions around the world to this requirement and even looking for replacements to soya in feeds.

Ethics

FAO has recently created a Committee on Ethics in Food and Agriculture, whereas UNESCO established an International Bioethics Committee (IBC) and an intergovernmental committee to examine its advice and recommendations. According to the IBC "Bioethics, as an awareness of the implications of the advances made in the life and health sciences, in particular genetics and molecular biology, is the basis of an ever-growing debate which transcends borders, since the concerns it expresses inevitably take on an international dimension."

DG XII of the EU has a common research sub-area ELSA (Ethical, Legal and Social Aspects of the Life Sciences and Technologies) where "transdisciplinary approaches to selected topics for the current programmes are promoting research on : legal protection of biotechnology inventions, biodiversity and regulatory framework for biological research; fundamental and applied values in biomedicine, embryo and fetus protection, personal data protection, resource allocation in health care, data bases and ethics committees; animal welfare, food safety, pesticides and crop protection, consumer attitudes and sustainable agriculture and fisheries."

The field of ethics is extremely broad and many international organizations are working on aspects of the subject, but under different terminology. For example the CCRF, the CBD, CAC et al. address many of these ethical

issues. Concerning GMOs, in addition to the above, ethical questions arise as to whether humans have the right to modify natural creations. Ethics enters the patenting arena where inventions that are contrary to public morality are disallowed. However what is moral to one society may be viewed differently in others. The Prince of Wales believes that, "(genetic modification) takes mankind into realms that belong to God, and to God alone"4 . However, I expect many vegetarians eat Parmesan cheese without knowing that it is made with calf intestine. Would genetic modification make cheese "more ethical" to this group? The process of raising animals to eat them is unethical to many societies, and in vitro fertilization was controversial when the first test-tube baby was born in 1978.

Concluding remarks

Aquatic GMOs will eventually also come under the mandate of the FAO Commission on Genetic Resources for Food and Agriculture (CGRFA), the only permanent United Nations inter-governmental forum dealing specifically with matters related to the conservation and utilization of genetic resources for food and agriculture, and related technologies. In 1997, the Commission established working groups on plant genetic resources and on farm animal genetic resources. However, fishery genetic resources, per se, have not yet been incorporated into the Commission’s work. The CGRFA is also preparing for negotiations on a Code of Conduct on Biotechnology, including a component on IPR.

Gene technology applied to food production is poorly understood by the public. With the confusing array of claims, counter claims, and scientific disagreement that is present in the media, the public has lost some faith in scientists and the government as honest brokers. A recent article in Science (Nov 5, 1999) also attributes this loss of faith to the "commercialization" of science, where industry supports academics and sits on government advisory boards. In

is legislation to transfer responsibility for food safety from the Health Department to the Agriculture Department which is seen by some as being a direct conflict of interest.

In light of the above, the public is more susceptible to emotive appeals and will follow information they think is more reliable. International conventions and organizations must recognize this, provide fora for informed discussions and strive to raise awareness and knowledge of genetic modifications, their opportunities, limitations and risks.

Acknowledgements

I wish to thank Jane Symonds and Stewart Hawthorn of New Zealand King Salmon Company for figure 1 and their cooperation. The review by Annick Van Houtte and Cristina leria of FAO Legal Office is also appreciated.

1 ICES.1995.ICES Code of practice on the introductions and transfers of marine organisms. International Council for the exploration of the Sea-Copenhagen, Denmark.5p.

2 Williams, N. 1998. Agricultural  biotech faces backlash in Europe. Science 281: 768 – 771.

3 IFOAM. 1998. Basic Standards for Organic Production and Processing. IFOAM Okozentrum Imsbach, D-66636 Tholey-Theley, Germany.

4 See note 2.

* Author’s note: As Fan 23 went to press an Extraordinary Meeting of the Conference of the CBD January 2000, had just adopted the biosafety protocols known as the "Cartagena Protocol". Implications of this protocal will be addressed in the future issues of FAN.