SLATE recently published (July 12, 2013) an op-ed entitled, “Let’s Make Genetically Modified Food Open-Source.” In the op-ed, the author argued against intellectual property rights (IPRs) in food crops or food products and against corporate seed breeders using modern biology to enhance crops through genetic modification. The author opined that IPRs in food owned by corporate seed breeders would slow innovation needed to provide food security for humanity. He argued that a better way to improve food security would come through the open-source use of biological information and the creative intelligence of “bio-hackers” (the author’s term) using the tools and knowledge of genetic engineering. (TechDirt commented on the SLATE piece here.)
Although the SLATE author did not expressly say so, the tools and knowledge that would be used in open source biotechnology are most likely to be found in synthetic biology. I have already co-authored an op-ed supporting synthetic biology and the creativity of synthetic biologists. I reassert my support for synthetic biology and synthetic biologists. But before readers of SLATE set forth on the road to an open-source cornucopia, I would like to provide a more realistic view of the journey and its obstacles.
NGO Opposition and international agreements
Open Source synthetic biology faces fierce and unrelenting opposition from environmental NGOs and anti-technology professional protest groups. From my perspective, synthetic biology appears to be in a similar position to that genetic engineering faced in the 1980s.
Regarding synthetic biology, the [U.S.] Presidential Commission for the Study of Bioethical Issues (PCSBI) issued a report in December 2010 entitled “New Directions – The Ethics of Synthetic Biology and Emerging Technologies.” Quoting from the report’s transmittal letter, “PCSBI concluded that synthetic biology is capable of significant but limited achievements posing limited risks. Future developments may raise further objections, but the Commission found no reason to endorse additional federal regulations or a moratorium on work in this field at this time.” The PCSBI conclusions about synthetic biology are remarkably similar to the conclusions reached about biotechnology by the Office of Science Technology, Coordinated Framework for the Regulation of Biotechnology (1986).
By contrast to the PCSBI report, the Conference of the Parties to the Convention on Biological Diversity (COP-11) in October 2012 adopted Decision XI/11, based on the precautionary approach, that invited the Secretariat to gather information so that the COP-12 can take decisions about future international actions regarding synthetic biology. The ETC Group, Friends of the Earth and Greenpeace International are the lead NGOs who pushed hard for this Decision XI/11. They hope that in 2014 the COP-12 will endorse a moratorium on synthetic biology until the international community can adopt an international regulatory regime specifically-focused on synthetic biology. This strategy by these three NGOs is remarkably similar to the disastrous but very successful strategy they adopted to demonize biotechnology through international agreements that came into effect in the 1990s and the 2000s.
Regulatory Time, Effort and Costs
The author of the July 12 SLATE op-ed denigrated Norman Borlaug (Nobel Peace Prize) and biotechnology companies as hope and hype for food security from biotechnology, blaming instead corporations and patents as the barriers to food security. I have co-authored an article that provides factual evidence that corporations and patents are not significant barriers to food security through biotechnology or synthetic biology.
The primary barrier to the diffusion of food security through biotechnology is unnecessary, discriminatory, and antagonistic regulation. I predict that regulatory time, effort, and costs will also be the primary barrier to the diffusion of food security through synthetic biology should the professional protest groups have their way.
Regulatory regimes have imposed monetary costs in the millions, caused the waste of thousands (if not tens of thousands) of employee hours, and time in years of delay for each biotechnological trait. In the United States and Europe and elsewhere, once a biotechnology trait enters the regulatory system, the applicant has entered Dante’s Purgatory, if not Kafka’s Trial. Years pass without a decision due to regulatory over-reaching, direct political pressure, and continuous NGO agitation through petitions and litigation.
Lest the readers think this paragraph is hyperbole or fiction, I will cite the evidence from public goods agricultural research.
Open-Source genetic engineering today
Cambia Technologies promotes open-source biotechnology and has done excellent work, particularly with transformation technologies that are widely used by public sector, public goods agricultural research. But despite this open-source assistance, despite the marvelous public sector agricultural research in genetically improved crops, there is one – only one – public sector biotechnology crop that has achieved commercial release – the virus-resistant papaya in Hawaii.
And the Hawaiian papaya growers (small growers all) had to petition for thirteen years before they could gain permission to enter the Japanese market. One public sector biotechnology crop on the market is today the single example of a commercialized public sector approach despite the successful agricultural adoption of biotechnology in canola, corn, cotton, and soybeans beginning in 1996.
Golden Rice is a public sector, public goods biotechnology-derived biofortified crop that could save millions of lives each year for those suffering from Vitamin A deficiency. Yet, Golden Rice has been caught in the vortex of regulatory demands and NGO opposition for more than a decade. As Ingo Potrykus, co-inventor of Golden Rice, has stated, “Genetic engineering contributions to food security depends nearly exclusively upon the failure of a radical anti-GMO industry.” He added that until the stultifying, non-scientific regulation of biotech crops ends, biotechnology will be marginalized from improving the lives of the poor of the world.
If the past history of public sector biotechnology is not convincing, one need look no further than the present-day Glowing Plants project, promoting open source biotechnology and educating the public about synthetic biotechnology. Glowing Plants sought to raise financing, through KickStarter, to produce and distribute plants enhanced with a completely safe and well-understood fluorescent gene. ETC Group and its allies tried to silence this freedom of thought and freedom of scientific inquiry through pressure on KickStarter and Glowing Plants. Simultaneously, ETC Group and its allies besieged the federal government to locate any statute by which to tie the project into knots through regulation. Finally, to panic the federal government to regulate, ETC Group and its allies spread falsehoods and fears through dishonest propaganda campaigns.
I applaud SLATE for its support for open source genetic engineering (likely through synthetic biology) and its goal of food security. But I caution the author of the July 12 piece to recognize that the obstacles in reality to an open source cornucopia are in NGO opposition and regulatory regimes. Intellectual property rights and private commercial efforts are neither necessarily nor directly in conflict with open source genetic engineering and synthetic biology. Indeed, open source genetic engineering and synthetic biology along with private commercial efforts, using IPRs, are complementary. Both should be encouraged and celebrated.