synthetic biology: self-regulation v.s. public oversight eric hoffman biotechnology policy...
TRANSCRIPT
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 [email protected]