Principles for the Oversight of Synthetic Biology

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The undersigned, a broad coalition of civil society groups, social movements, local and indigenous communities, public interest, environmental, scientific, human rights, religious and labor organizations concerned about various aspects of synthetic biology’s human health, environmental , social , economic, ethical and other impacts, offer the following declaration, “The Principles for the Oversight of Synthetic Biology.” (For a current list of signatories please visit Friends of the Earth/

Executive Summary
Synthetic biology, an extreme form of genetic engi
neering, is developing rapidly with little oversight or regulation despite carrying vast uncertainty. Standard forms of risk assessment and cost-benefit analyses relied on by current biotechnology regulatory approaches are inadequate to guarantee protection of the public and the environment. The Precautionary Principle is fundamental in protecting the public and our planet from the risks of synthetic biology and its products.
A precautionary approach requires synthetic biology-specifc oversight mechanisms that account for the unique characteristics of synthetic organisms and their products. Additionally, it assesses the novel consequences of synthetic organisms and products of synthetic biology as well as full consideration of alternative options. Ensuring public health, worker safety and ecosystem resilience requires a committed focus on developing a critical public interest research agenda that includes risk research and development of alternatives, a robust pre-market regulatory regime, strong enforcement mechanisms, immediate action to prevent potential exposures until safety is demonstrated and ongoing monitoring for unintended consequences and immediate action to prevent potential exposures until safety is demonstrated. Protection of the public includes a ban on using synthetic biology to manipulate the human genome in any form, including the human microbiome. Decisive action must also be taken to protect the environment and human health and to avoid contributing to social and economic injustice. Developers and manufacturers must be responsible for the safety and effectiveness of their processes and products and must retain liability for any adverse impacts. Throughout, research and regulation shall be transparent and provide public access to all information regarding decision-making processes, safety testing and products. Open, meaningful and full public participation at every level is essential
and should include consideration of synthetic biology’s
wide-ranging effects, including ethical, social and economic results. No synthetic organism or their synthetic building blocks should be commercialized or released without full disclosure to the public of the nature of the synthetic organism and results of safety testing.
 This document outlines the following principles necessary for the effective assessment and oversight of the emerging field of synthetic biology:

I. Employ the Precautionary Principle

II. Require mandatory synthetic biology-specific regulations

III. Protect public health and worker safety

IV. Protect the environment

V. Guarantee the right-to-know and democratic participation

VI. Require corporate accountability and manufacturer liability

VII. Protect economic and environmental justice
Governmental bodies, international organizations and relevant parties must immediately implement strong precautionary and comprehensive oversight mechanisms enacting, incorporating and internalizing these basic principles. Until that time, there must be a moratorium on the release and commercial use of synthetic organ- isms and their products to prevent direct or indirect harm to people and the environment.

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For more information or copies of this declaration, contact:
Eric Hoffman
Food and technology policy campaigner
Friends of the Earth U.S.
1100 15th St. NW, 11th Floor
Washington, D.C. 20005