"Public Interest" Groups Call for Synthetic Biology Regulation

McDonnell Boehnen Hulbert & Berghoff LLP

[author: Kevin E. Noonan]


A broad coalition of 111 public interest groups announced today a manifesto for containing "synthetic biology," a term with a loose definition (including "extreme genetic engineering") that includes efforts such as Craig Venter's to produce novel microorganisms to more traditional biotechnology efforts in transgenic plants and animals and other genetically modified organisms (see "Not Quite Artificial Life, But We're Getting Closer: Reactions to Venter's Synthetic Cell").  The effort was the occasion for a press conference this morning, hosted by the Friends of the Earth and featuring four speakers:

• Jaydee Hanson -- Policy Director at the International Center for Technology Assessment
• Dr. Stuart Newman -- Professor of Cell Biology and Anatomy at New York Medical College and board member of the Alliance for Humane Biotechnology
• Becky McClain -- biotechnology whistleblower and Injured Workers National Network
• Silvia Ribeiro -- Latin American Director for the ETC Group

Eric Hoffman, Food & Technology Policy Campaigner at Friends of the Earth U.S., moderated the conference, introducing the principle motivation for the proposal:  that government regulators have prematurely deemed the technology safe, which poses a risk to humans, the earth, and its other inhabitants.

Dr. Hanson started the conference, pointing out the "newness" of the technology and distinguishing this iteration of the biotechnology revolution with the one 40 years ago, based on the difference between copying a gene from one organism into another and "writing" an entirely new gene (or genome).  He also cautioned against simplistic metaphors for genetic manipulation, such as bricks or computer code, in view of the undeniably more complex nature of this technology.  His message was simple:  we don't know enough about how genes or organisms work to be creating new ones.

Dr. Newman continued with this theme, noting that another difference between the first biotechnology revolution and this one is that in the 1970's, the NIH created guidelines for containing genetically modified organisms (both physically and biologically), while this revolution is aimed at "releasing" genetically modified organisms into the environment in the form of modified foodstuffs, biofuel producers, etc.  It was noted that, in addition to his scientific accomplishments and work with the Alliance for Humane Biotechnology, Dr. Newman was named as an inventor in an application filed several years ago directed to a human-pig chimera (at the behest of his friend, Jeremy Rifkin, who spearheaded attempts in Cambridge, MA and elsewhere to contain the first biotechnology revolution).  (If memory serves, the U.S. Patent and Trademark Office refused to examine Dr. Newman's patent application.)

Ms. McClain gave the most personal and most frightening testimonial, embodying all the fears of corporate misfeasance and unchecked and dangerous technology.  According to Ms McClain, she was a molecular biologist working for a drug company on recombinant microorganisms and became ill after exposure to such a recombinant.  She catalogued several unsafe practices in the workplace and how her efforts to correct them were met with resistance and finally refusal to remedy or even address the situation.  Tragically, Ms. McClain described not only the disastrous effects of her experience on her career and health, but the failure of the legal system to provide redress because the evidence of causation was lacking (according to her, having been suppressed or destroyed by her former employer).  She also reminded the audience (during the Q&A following the speakers' prepared remarks) that the nature of this technology -- novel genetically engineered organisms -- could make it impossible for any future injured worker to successfully sue, since the diseases that may result from exposure (inadvertent or otherwise) would not be something readily recognized by a doctor as a human disease.  This comment was reminiscent of the early response to HIV infection in the 1980's.

The final speaker, Ms. Ribiero, included in her remarks many of the ills of Western capitalism visited on developing and underdeveloped companies in addition to synthetic biology, correctly noting that the indigenous people in such countries are at risk for harmful consequences of corporate liasons with local governments that may enrich some at a societal cost to the majority that may not be noticed in the U.S.  These concerns are encapsulated in a quote from Ms. Ribiero in the group's e-mail announcing release of the Principles:

In addition to the risks synthetic biology poses to human health and the environment, this technology may also deepen global social and economic injustices.  Novel organisms tailored to break down biomass will enable a new bio-economy in which land, water and fertilizers used to produce food for communities in the global South will be diverted for producing biomass feed for synthetic organisms in order to produce fuels, chemicals and other high-end products for wealthy nations.

There was a lively question and answer period following the prepared remarks; the most interesting comment came in response to a question from a reporter covering the U.S. Environmental Protection Agency.  She asked how the group expected to provoke the U.S. Congress to pass needed legislation in this area in view of partisan gridlock, and the response was that it could (and, the suggestion was, would) be done through riders to appropriations bills.  Not a prospect likely to provide the type of factfinding or deliberations that the topic no doubt warrants, but certainly a politically astute strategy.

The proposal was released over the Internet today, entitled The Principles for the Oversight of Synthetic Biology, and has the following points: 

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

The upshot of the Principles is a call for a moratorium on "the release and commercial use of synthetic organisms and products."  The justification is that such a moratorium is necessary "to safeguard public health and the environment from the novel risks of synthetic biology and to ensure open, meaningful and full public participation in decisions regarding its uses."

The Precautionary Principle (said to be incorporated into many international conventions, including the Rio Declaration on Environment and Development, the Cartegena Protocol on Biosafety, the U.N. Framework Convention on Climate Change, the World Charter on Nature, the London Convention on the Prevention of Marine Pollution by Dumping Wastes and Other Matter, and the Agreement for the Implementation of the Provisions of the United Nations Convention on the Law of the Sea) reads as follows:

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.  In this context the proponent of an activity, rather than the public, should bear the burden of proof.  The process of applying the Precautionary Principle must be open, informed and democratic and must include potentially affected parties.  It must also involve an examination of the full range of alternatives, including no action.

In accordance with the application of this Principle espoused in the report, the coalition rejects voluntary compliance with good practices codes or other forms of self-regulation by the biotechnology industry, and proposes mandatory government regulation instead.  The coalition specifically calls for a ban on human genetic engineering and other extensions of genetic technology into the human species, saying:

The use of synthetic biology to change the human genetic makeup — including the human genome, epigenome and human microbiome — must be prohibited.

Enforcement of the "strictest levels of physical, biological and geographical" containment of synthetic biology is also proposed, and the groups’ proposal envisions a "legally enforceable right" by the public to comment (and presumably prevent) particular applications of the technology before they are implemented, with corporations and other developers of the technology being financially liable for any "harm" cause to the public or the environment.  Finally, uses of the technology that would "deepen economic and social injustice" should be prohibited (although it is difficult to see how such outcomes could be predicted reliably).

The report in its entirety can be found here, and the groups endorsing this approach are:

African Biodiversity Network
Agricultural Missions, Inc (AMI) (U.S.)
Alliance for Humane Biotechnology (U.S.)
Amberwaves (U.S.)
Amigos de la Tierra España
Asociacion ANDES (Peru)
Asociación para la Promoción y el Desarrollo de la
Comunidad CEIBA / Friends of the Earth Guatemala
Basler Appell gegen Gentechnologie" (Appeal of Basle against Genetic-Manipulation) (Switzerland)
Biofuelwatch (International)
Biotechnology Reference Group of the Canadian Council of Churches
Biowatch South Africa
Brazilian Research Network in Nanotechnology, Society, and Environment - RENANOSOMA
Bund für Umwelt und Naturschutz Deutschland / Friends of the Earth Germany
Canadian Biotechnology Action Network (CBAN)
Center for Biological Diversity (U.S.)
Center for Food Safety (U.S.)
Center for Genetics and Society (U.S.)
Center for Humans and Nature (U.S.)
Center for International Environmental Law (U.S.)
Centro Ecológico (Brazil)
Centre for Environmental Justice/Friends of the Earth Sri Lanka
CESTA - Amigos de la Tierra, El Salvador
Citizens' Environmental Coalition (U.S.)
COECOCEIBA - Friends of the Earth Costa Rica
Columban Center for Advocacy and Outreach (U.S.)
Community Alliance for Global Justice (CAGJ) (U.S.)
Development Fund (Norway)
Diverse Women for Diversity (India)
Doctors for Food Safety & Biosafety (India)
Econexus (International)
Ecoropa (Europe)
Envirocare (Tanzania)
Environmental Rights Action/Friends of the Earth Nigeria
ETC Group (International)
Ethiopian Society for Consumer Protection (ETHIOSCOP)
European Network of Scientists for Social and Environmental Responsibility (ENSSER)
Family Farm Defenders (U.S.)
Federation of German Scientists
Food Democracy Now! (U.S.)
Food & Water Watch (U.S.)
Friends of the Earth Australia
Friends of the Earth Brazil
Friends of the Earth Canada
Friends of the Earth Cyprus
Friends of the Earth Latin America and the Caribbean (ATALC)
Friends of the Earth Mauritius
Friends of the Earth U.S.
Friends of ETC Group (U.S.)
Gaia Foundation (U.K.)
Gene Ethics (Australia)
GeneWatch UK
GLOBAL 2000/FoE Austria
Global Forest Coalition (International)
GM Freeze (UK)
GMWatch (UK)
IBON International
Indian Biodiversity Forum
Indigenous Peoples Council on Biocolonialism (U.S.)
Initiative for Health & Equity in Society (India)
Injured Workers National Network (U.S.)
Institute for Agriculture and Trade Policy (U.S.)
Institute for Responsible Technology (U.S.)
International Center for Technology Assessment (U.S.)
International Peoples Health Council (South Asia)
International Union of Food, Agricultural, Hotel, Restaurant, Catering, Tobacco and Allied Workers' Associations (IUF) (International)
Jamaican Council of Churches
Karima Kaaithiegeni Ambaire (CBO) (Kenya)
Latin American Nanotechnology & Society Network (ReLANS)
Loka Institute (U.S.)
MADGE Australia Inc.
Maendeleo Endelevu Action Program (MEAP) (Kenya)
Maryknoll Office for Global Concerns (U.S.)
Midwest Environmental Justice Organization (U.S.)
Movimiento Madre Tierra (Honduras)
Mupo Foundation (South Africa)
Nanotechnology Citizen Engagement Organization (U.S.)
National Association of Professional Environmentalists (Friends of the Earth Uganda)
Navdanya (India)
NOAH Friends of the Earth Denmark
Non-GMO Project (U.S.)
No Patents on Life! (Germany)
Northeast Organic Farming Association -- Interstate Council (NOFA-IC) (U.S.)
Organic Seed Growers and Trade Association (U.S.)
Otros Mundos AC/Amigos de la Tierra México
Our Bodies Ourselves (U.S.)
Partners for the Land & Agricultural Needs of Traditional Peoples (PLANT) (U.S.)
Pesticide Action Network North America
Pro-Choice Alliance for Responsible Research (U.S.)
Pro Natura – Friends of the Earth Switzerland
Public Employees for Environmental Responsibility (PEER)
Rescope Programme (Malawi)
Research Foundation for Science, Technology, and Ecology (India)
Rural Coalition (U.S.)
Save our Seeds (Europe)
Say No to GMOs! (U.S.)
Schweizerische Arbeitsgruppe Gentechnologie SAG (Swiss Working Group on Genetic Engineering)
Science & Environmental Health Network (U.S.)
Seed Stewards Association of Turkey
Sobrevivencia – Amigos de la Tierra Paraguay
Sustainability Council of New Zealand
Sustainable Living Systems (U.S.)
Testbiotech (Germany)
Third World Network (International)
Timberwatch Coalition (South Africa)
Tree Is Life Trust (Kenya)
USC Canada
VivAgora (France)
Washington Biotechnology Action Council (U.S.)
Women in Europe for a Common Future (International)
World Rainforest Movement (International)


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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