Notes on Biosafety and
Devin M. Bartley
Fishery Resources Division
International efforts are underway to develop regulations governing the use and transboundary movement of genetically modified organisms (GMOs) and living modified organisms (LMOs)1. Foremost in this regard are the negotiations of the International Convention on Biological Diversity's (CBD) Ad hoc Working Group on Biosafety, which are designed to create internationally binding protocols on biosafety. FAO has worked and continues to work closely with the CBD and others on issues relevant to the sustainable use and conservation of aquatic genetic resources. National legislation and guidelines are also being developed, such as the Performance Standards for Safely Conducting Research with Genetically Modified Fish and Shellfish that were created by a working group organized by the US Department of Agriculture (http://www.nbiap.vt.edu/perfstands/psmain.html ).
Biosafety, as currently discussed in the CBD, refers to environmental and human health safeguards concerning living modified organisms produced by modern biotechnology, especially biotechnology related to gene-transfer or transgenics. In the aquaculture sector, gene-transfer is still not commercially viable, but there are several pilot projects and research programmes in many parts of the world that are developing commercially important transgenic fish, such as salmon, catfish, carps, and tilapia. However, other biotechnologies, such as chromosome manipulation, sex-reversal, hybridization, and conventional selective breeding are becoming more widespread in aquaculture. In light of the fact that most aquatic biological diversity still resides in natural populations, all biotechnologies have the potential, both to improve greatly production, because of the "unimproved" state of wild aquatic species, and to impact adversely those wild resources. Thus a narrow scope of the current biosafety protocols. i.e. focusing primarily on transgenics, should be carefully considered. All of the wild relatives of domesticated aquatic species are still found in nature; biosafety protocols, or similar regulations, should eventually strive to protect these resources while allowing for the development of aquaculture and international trade.
The use of introduced species and genotypes is also a practice that can greatly increase production, but also has the potential to damage natural genetic diversity and ecosystems. In the CBD, "introduced species" are referred to as "alien species" and the term refers to species that are introduced into an area where they do not naturally occur, e.g. the movement of rainbow trout, Oncorhynchus mykiss, from North America to Europe. "Alien genotypes" is another phrase that is being used in international fora and would include in addition to alien species, those genetically differentiated populations that are transferred from one part of their natural distribution to another, e.g. the movement of rainbow trout from California to British Colombia. Hybridization of two local species that do not naturally hybridize would also create an alien genotype, e.g. the hybridization of Colossoma and Piaractus in Venezuela.
Biosafety in the following section refers only to environmental safeguards. Safeguards concerning human health fall under the domain of the FAO/WHO Codex Alimentarius Commission, the Agreement on the Application of Sanitary and Phytosanitary Measures, and the Agreement on Technical Barriers to Trade of the WTO.
1 The definition of LMOs and GMOs is somewhat controversial. The Convention on Biological Diversity uses an internationally accepted definition of LMO as an organism that has been modified by modern biotechnology; the International Council for the Exploration of the Sea uses the European Union's definition of GMOs to include organisms in which the genetic material has been altered anthropogenically by means of gene or cell technologies.
The FAO Fisheries Department supports the responsible use of biotechnologies and alien species. The primary instruments for this support are the FAO Code of Conduct for Responsible Fisheries (CCRF) and a series of guidelines and codes of practice governing the movement of alien aquatic species (Table 1). Foremost among the latter are the International Council for the Exploration of the Sea/European Inland Fisheries Advisory Commission (ICES/EIFCA) codes of practice on aquatic introductions. These codes of practice have been adopted in principle by FAO and FAO regional fishery bodies. FAO and others are working to facilitate their implementation (Table 1).
The FAO Code of Conduct for Responsible Fisheries was adopted in 1995 by the 28th Session of the FAO Conference and provides a framework for the sustainable use and conservation of aquatic biodiversity. The Code contains Articles on:
. General Principles
· Fisheries Management
. Fishing Operations
· Aquaculture Development
· Integration of Fisheries into Coastal Area Management
· Post-harvest Practices and Trade· Fisheries Research
Aquaculture is a primary reason for the purposeful introduction of aquatic alien species, as well as being the main motivation for the use of living modified organisms. Article Nine of the CCRF, on Aquaculture Development, deals specifically with these topics: Article 9.2 on the "Responsible development of aquaculture including culture based fisheries with transboundary aquatic ecosystems", and 9.3 on the "Use of aquatic genetic resources for the purpose of aquaculture, including culture-based fisheries" apply. FAO has produced Technical Guidelines on Aquaculture Development to facilitate the implementation of Article 9 of the CCRF.
FAO is now actively assisting countries promote and implement the CCRF. For example, a Technical Co-operation Programme project in Malaysia, TCP/MAL/6611 "Assistance in the Preparation of a Legal Framework for Responsible Aquaculture Practices", will facilitate creation and implementation of a code of conduct for responsible cage culture and shrimp culture that follows on from the CCRF and contains elements on use of alien species and living modified organisms. Recognizing that pathogens also may accompany movement of alien species, a regional TCP in Asia, "Assistance for Responsible Movement of Live Aquatic Organisms" ( TCP/RAS/6714(A)) has been established to create an information system and guidelines on quarantine and health certification of aquatic animals (see related article p . 19).
To assess potential environmental and socio-economic impacts of alien species, a Database on Introductions of Aquatic Species (DIAS) has been established as a searchable database on th FAO WAICENT http://www.fao.org/waicent/faoinfo/fishery/statist/fisoft/dias /index.htm.
The database will be periodically updated and eventually modified to include living modified organisms.
The scope of the biosafety protocols currently being negotiated by the CBD and procedures for risk assessment are controversial subject areas. Regarding the scope, segments of the aquaculture industry wants to restrict the protocols to primarily transgenics and to leave other genetic modifications unregulated, or at least less regulated. Similarly, alien species would not be covered by the protocols. Efforts to restrict the scope of the protocols are motivated by concern about possible over-regulation of common practice, which would hinder aquaculture trade and development. In addition, there is the feeling by some that gene-transfer technologies are inherently more risky than other genetic manipulations and the impacts less well known, or unknown.
Counter to this is the belief that all organisms that have had their genome modified, e.g. hybrids, polyploids, sex-reversed animals, and domesticated species, as well as alien species, have the potential to harm aquatic ecosystems and should be subject to biosafety protocols. Furthermore, many molecular geneticists working on transgenics claim that it is not justified
to target a single technology , such as transgenics, when other practices also have the potential to cause environmental harm. Thus we are brought into a debate on whether to regulate a technology or the result of the technology, i.e. regulation based on the process or on the product. A recent international conference sponsored by the Sustainable Development Department and the Inland Water Resources and Aquaculture Service of FAO and the International Center for Living Aquatic Resources Management (Bellagio Conference; see Table 1) agreed that the primary consideration in risk assessment concerning genetic modifications should be the phenotypic change that the technology has imparted to an organism, and not what technology was used to impart the change. Furthermore, the receiving environment, or potentially affected environment, is crucial in risk assessment; a organism that presents no threat in one environment, may be hazardous in another. Practices of genetic modification associated with more scientific uncertainty as to the phenotypic change that they impart on the organism should be regulated and monitored more closely, as efforts are made to improve scientific information and reduce uncertainty.
A further complication is being addressed by the CBD's Ad hoc Working Group on Biosafety, namely that there are discussions to regulate the products of living modified organisms, e.g. fermented products that have been developed from genetically modified micro-organisms. These concerns are more closely associated with human health aspects, and as such, are being addressed by Codex Alimentarius. Tilapia are being genetically engineered to produce insulin for treatment of diabetes in humans _ would the trade or transport of the insulin be subjected to the biosafety protocols, even though it may be identical to human insulin?
It is not the intention of this note to try to change the ongoing negotiations of the Ad hoc Working Group on Biosafety, but to highlight important issues related to the responsible use of biotechnologies and alien species and point to areas where the Fisheries Department of FAO can offer expertise and assistance. Readers that are aware of specific cases of successes or problems derived from the use of biotechnologies and living modified organisms are encouraged to contact the Fisheries Department so that we may benefit from your experiences and help pass the information along.