Can genetically modified algae feed and fuel the world, as scientific entrepreneur J. Craig Venter predicted in 2011? For entrepreneurs of manufacturing with algae biomass, the future is now. That was the message of the Algae Biomass Organization (ABO) Summit held September 30th to October 2nd in Washington, DC. Yet, to the product developers who rely on synthetically modified microbes to genetically “edit” and customize algae for industrial and agricultural purposes, an Environmental Protection Agency (EPA) hearing on “new microbes” modified by “Advanced Genetic Engineering” posed a lot of questions. For some of those questions, there are not yet answers; at least parts of the algal future are not now.
IATP participated in both events, which covered the scientific, engineering, regulatory and financial challenges of an industry poised for take-off with the robust help of government investment and policy. Our agricultural take-away from the meetings was this: farmers looking for a cheap source of fertilizer or protein for animal feed from the biomass by-product of algae derived bioproducts may get more than they bargain for. As we told the EPA, the modification of algae by “Advanced Genetic Engineering” does not yet include successful techniques to keep the genes of the modified algae from outcrossing and acting as an invasive species or a weed among agricultural plants. Given the at least 60 million acres of “super-weeds” infesting U.S. farmlands, farmers can ill-afford the further expense of controlling another generation of super-weeds.
ABO members, whether start-ups or huge prospective algal biofuels users, such as Boeing, had good cause to celebrate. The EPA’s recently announced Clean Power Rule includes a provision for production of algal products using carbon dioxide emissions to qualify as a method for power plants and other major greenhouse gas emitters to meet their emissions reduction targets. The EPA ruling not only cleared a pathway for making large scale algal biofuel more economically viable, but also made the commercial future of co-products, such as algal livestock feed and fertilizer, more attractive to investors.
As someone whose previous knowledge of algae was limited to seaweed wrapped around sushi, spirulina in green smoothies and the slime that covers many Minnesota lakes in August, my visit to the Summit exhibitors’ technology provided a quick algal education. Some of the topics discussed included the open pond raceway design to reduce energy use by a factor of ten, technology to increase the efficiency of the capture and use of CO2 by a factor of fifteen and algae harvesting and dewatering technology to increase primary harvesting by a factor of eight over conventional algae technology. All of these advances were advertised by just one firm, Global Algae Innovations, which was looking for partnerships to produce high value products such as cosmetics, pigments and “nutraceuticals” such as dietary supplements.
Apart from the cost-control challenges of deciding which equipment to buy to grow and dry various strains of algae were the scientific challenges in selecting and modifying the algal seed from which the rest of the biomass is grown. Advances in sequencing and transcribing genetics have aided the process of selecting useful strains of algae. Some production methods use “new microbes,” whose regulatory review is carried out by the EPA under the Toxic Substances Control Act (TSCA) of 1976.
To put this in context, one must understand that Congress is undertaking a controversial process of TSCA “modernization” that will continue to allow the chemical industry to add to the 22,000 chemicals already registered by the EPA for commercial use since 1976 without a formal risk assessment about the safety of those chemicals. The bill proposed by Senators David Vitter and Tom Udall would end the ability of state governments to require more extensive information from manufacturers than the EPA does about chemicals introduced into commerce. The bill does not provide new authority for the vastly underfunded and understaffed EPA to regulate the “new microbes” used for some algal production methods. On October 2nd, Senator Udall’s office announced a TSCA bill compromise to secure a filibuster proof majority.
The EPA is revising its 1997 “Points to Consider in the Preparation of TSCA Biotechnology Submissions for Micro-organisms.” Because the 1997 document did not envision the genetic modification of algae, the EPA is also developing a ”Considerations for GM/Synbio Algae” document that will outline the kinds of information industry applicants will need to submit in order to receive an EPA “registration” or commercial approval for their product. The EPA held a public hearing to gather input for the document and is inviting written comment on it by October 30th.
Each commenter had three minutes to respond to one of four categories of “Charge Questions” put forward by the EPA. I responded to the questions concerning “Advanced Genetic Engineering.”
The first question concerned the synthetic biology “kill switches” that are supposed to keep the genes in synthetically modified microbes from crossing over into other plant species, i.e. Horizontal Gene Transfer (HGT). There is a concern among algae biosafety researchers that modified algae could escape into natural environments and outcompete wild and agricultural plants. Avenues of escape could include GM algae biomass used as fertilizer, GM algae carried from open ponds by birds or animals and microalgae carried by the wind.
According to a 2015 Scientific Opinion by three European Commission scientific committees, “no single technology solves all biosafety risks and many new approaches will be needed.” However, multiple devices to prevent HGT could overload the host microbes and result in failure to contain.
A second question asked which of the various synthetic biology techniques offered the most likely success of containing the synthetically engineered genes. Commercial applicant answers to the EPA about that question may not be public for specific products. Commercial applicants often claim to the EPA and other regulators that product data and information is Confidential Business Information (CBI), even if it pertains to public or environmental health and even if protected by patents. If the EPA continues to routinely grant CBI status to such data and information, the public engagement that the EPA says it wants about synthetic biology cannot be scientifically substantive. CBI prevents independent scientific peer review of the applicant’s data and information, and reduces communication to a dialogue between a handful of regulatory and product developer scientists.
The EPA responded to my comment by stating that the revision of the 1992 “Coordinated Framework for the Regulation of Agricultural Biotechnology,” ordered by the White House in a July 2 memo, would elicit comment about which parts of commercialization applications for genetically and synthetically modified biotechnology products should be granted CBI status and why. (Pat Rizzuto, “EPA Lists Extensive Data Needs for Bioengineered Algae,” Bureau of National Affairs, September 30, 2015. Subscription required.)
It is not clear when the EPA will produce new guidance to industry documents on information to be submitted for synthetically engineered microbes. Nor is it clear as to which of the algal biomass products will be affected by the guidance. What is clear is that algal biomass product developers and equipment manufacturers believe that they are crucial participants in “Creating a New Carbon Economy” and in “Sustainable Health and Nutrition” to partly quote plenary session titles.
Some of the algal entrepreneurs are developing products that respond to imminent environmental threats with major economic consequences. Professor Charles Yarish showed how to breed and grow seaweed strains that greatly reduced the excessive nitrate levels from agricultural fertilizers that were polluting the waters of the Long Island Sound. Professor Pallab Sarker of Dartmouth College argued that only algal-based fish food could stem the collapse of marine feeding chains that result when sardines, anchovies and other small fish are fed to salmon and other farm-raised fish. No doubt I missed many excellent presentations. There were three to four concurrent sessions during the Algae Biomass Summit and about 200 hundred posters that described scientific, engineering and commercialization initiatives.
Some of the technological objectives of algal entrepreneurs and scientists have been achieved at the level of pilot plant production levels, e.g. producing algal-based fuel that meets the requirement of the Secretary of the Navy. Scaling up production to a commercial level, to the point of competing economically with traditional energy and agricultural commodities, may require not only the support of the EPA and Departments of Defense and Energy; it may require solving biosafety problems of HGT that currently appear to be intractable, especially given the strictures of CBI claims on independent scientific review.
