SYNTHETIC BIOLOGY:

SELF-REGULATION V.S. PUBLIC OVERSIGHT

Eric HoffmanBiotechnology Policy Campaigner

Friends of the Earth U.S.

Current State of Biotechnology Regulation 1986 Coordinated Framework for

Regulation of Biotechnology Biotech products do not pose novel risks Regulate products, not process

Patchwork Oversight FDA regulates drugs, GE animals USDA regulates GE crops (APHIS) EPA regulates release of GE organisms

(TSCA)

Synthetic Biology-Specific Regulations Voluntary guideline for DNA synthesis

companies to screen orders that could be used to create items on the Select Agents and Toxins list

RAC decided to not oversee synthetic biology work if using 100 nucleotides or less (at the request of the pharmaceutical industry)

Self-Regulation? (Or Letting the Fox Watch the Henhouse)

Industry has been pushing for the idea of “self-regulation”

Asilomar as guiding example of biotech industry self-regulation Synbio 2.0 failed to agree to even the weakest

of self-governance princples Venter and Endy’s “Synthetic Genomics: Options

for Governance”

Presidential Commission for Bioethics:“Self-Regulation OK, But Just be Careful”

Guiding Principles•Promoting Public Beneficence•Promoting Responsible Stewardship•Promoting Intellectual Freedom and Responsibility•Promoting Democratic Deliberation•Promoting Justice and Fairness

www.bioethics.gov

Need for Precautionary Oversight Self-governance is no substitute for real

oversight Inherently impossible to predict risks of

novel synthetic organisms Must protect public health, worker

safety, and well-being of communities Democratic decision-making and

transparency must guide development of all emerging technologies

In reality…

“The president’s bioethics commission has concluded that there is no need to temporarily halt research or to impose new regulations on the controversial new field known as synthetic biology. ..The commission recommended self-regulation by synthetic biologists.”

– New York Times

Response from Civil Society

Letter from 58 organizations working in 22 countries critiquing their recommendations

Main areas of concern:1. Ignores the Precautionary Principle2. Lack of concern on environmental impacts3. Reliance on “suicide genes”4. Reliance on Self-Regulation

Other Areas of Concern:

Recommended “Prudent Vigilance” instead of the Precautionary Principle

Assumed all harms are in distant future but all benefits right around the corner

Only spoke with one person from civil society, one ecologist. Didn’t speak with anyone from global South

Thank you10

Eric HoffmanBiotechnology Policy CampaignerFriends of the Earth U.S.ehoffman@foe.org202.222.0747