“PRECAUTION AND THE REGULATION OF LIVING MODIFIED ORGANISMS (LMOs)” EMMA ISSATT AquaBounty ‘AquAdvantage’ Salmon Timeline of PP 1970s W. German Vorsorgeprinzip 1982 UN World Charter for Nature 1985 Vienna Convention on 1992 Convention on Biological Diversity 1992 UN Framework Charter on Climate Change 1998 Persistent Organic Protection of the Ozone Layer Pollutants Protocol 2000 Cartagena Protocol on Biosafety 1990 Bergen Ministerial Declaration on Sustainable Development 1992 UN Rio Declaration on Environment and Development And the rest… Defining PP Rio 1992: In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” Wingspread Declaration 1998:When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. EC Communication on PP 2000:when there are reasonable grounds for concern that potential hazards may affect the environment or human, animal or plant health, and when at the same time the available data preclude a detailed risk evaluation, the precautionary principle has been politically accepted as a risk management strategy in several fields. COMEST 2005: When human activities may lead to morally unacceptable harm that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish that harm. Trends in PP What PP does not aim to be Zero risk A decision-making tool A barrier to trade Protectionism Stifling of scientific innovation Placing unfair burden of proof of safety Leading to paralysis Is PP a legal principle or not? Principle: Their utility is based on three fundamental aspects. First, principles should be considered as one of the standards, among others, that allow the evaluation of the validity of a law. Second, principles have the potential to assist in the interpretation of other rules. And, third, principles have the capacity to ﬁll legal gaps. Comest 2005 Not sure: Sands, de Sadeleer –yes. Birnie & Boyle –unsure. Sunstein –no. European Commission- yes. Mox 2001/2003 –yes off the record. Southern Bluefin Tuna –yes but not explicit. Beef Hormones – unsure. Precaution and the Precautionary Principle in the Regulation of LMOs Cartagena Protocol 2000 – PP EC Directives & Regulations - PP Federal Food Drug and Cosmetic Act – not PP US State Laws – not PP Cartagena Protocol on Biosafety 2000 Aim: ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements PP measures: Rio pr.15 Advance Informed Agreement ERA Biosafety Clearing House Monitoring, Labelling, Traceability EC Directives & Regulations 2001/18 1829/2003 Aim: In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when: - carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community, - placing on the market genetically modified organisms as or in products within the Community. PP measures: Cites PP Risk Ass. –Notes and Guidelines EFSA -independent assessment 1830/2003 1946/2003 65/2004 Aim: provide a framework for the traceability of products consisting of or containing genetically modified organisms (GMOs), and food and feed produced from GMOs, with the objectives of facilitating accurate labelling, monitoring the effects on the environment and, where appropriate, on health, and the implementation of the appropriate risk management measures including, if necessary, withdrawal of products. PP measures: PP Risk Management Labelling Traceability Unique Identifier Code for GMO labels Transboundary Movements= Notify Commission Biosafety Clearing House US Food Drug and Cosmetic Act Aim: Regulate Drugs and Cosmetics. Center for Veterinary Medicine NADA PP measures: Risk Assessment Environmental Assessment Monitoring Labelling Traceability Recall or further data requested, at any time GloFish® US State Laws Some thoughts about PP… American hostility “We consider it to be a mythical concept, perhaps like a unicorn” Has PP evolved (or fragmented)? Risk Assessment Monitoring Traceability Labelling Clearing Houses Thank you!