In the previous post, I reported on a public meeting entitled “Considerations for Risk Assessment of Genetically Engineered Algae”, that was convened by the EPA on September 30, 2015. EPA solicited further public comment on these issues, in a comment period that ran until October 31. I had given brief oral comments at the public meeting, primarily on behalf of Joule Unlimited Technologies, and then I followed this up by submitting written comments on behalf of both D. Glass Associates and Joule. My oral and written comments addressed specific questions EPA posted prior to the meeting, as well as a draft of a guidance document for industry entitled “Considerations for Risk Assessment of Genetically Engineered Algae” that was posted online ahead of the meeting. The following is a summary of those comments.
My comments began with a general statement of support for reasonable, science-based regulation overseeing the development of industrial biotechnology and ensuring that appropriate risk assessments are made as the technology develops. I’ve always found EPA’s regulatory program to be effective in assessing potential health and environmental risks while offering a clear path for commercial development of those technologies determined not to pose unreasonable risks. I emphasized that industrial biotechnology companies were developing products that hold the promise of substantial societal benefits in reducing greenhouse gas emissions, providing innovative solutions for carbon capture and utilization, and providing environmentally-friendly alternatives to uses of fossil fuels, while avoiding the use of feedstocks based on food crops and without using arable land that would best be used for food production.
Moving next to more substantive comments, I argued that it is important to build a database of environmental effects of algae and cyanobacteria strains that are intended for industrial uses subject to TSCA, but noted that regulatory risk assessments are strain-specific, so a general database of adverse environmental effects, while useful, but would be of little value in a risk assessment of an organism based on a recipient strain with no history of any deleterious traits. I suggested that EPA might compile, or sponsor the compilation of, a database of algal and cyanobacterial strains known in the literature not to express toxins, cause harmful blooms, or otherwise have deleterious effects, so that applicants could be encouraged to select such strains as recipient strains for genetic modification. In any event, however, EPA’s risk assessment of modified algae should focus on whether the introduced genetic modifications change the predicted behavior or risk characteristics of the starting recipient strain, and if such changes are not likely, then the use of the modified strain is unlikely to pose any environmental or safety risks.
The comments went on to suggest that EPA continue to allow MCAN or TERA applicants to rely on genomic or proteomic analysis of proposed recipient strains to address whether such strains produce toxins or might be pathogenic or virulent. This strategy has been pursued at least by both Joule and Algenol in MCANs for cyanobacteria strains, and has been based on the significant literature that has developed on the genes encoding toxin production or other pathogenic traits in algae and cyanobacteria. The ability to quickly and routinely search a sequenced genome for the presence of nucleic acid sequences encoding such function can be a powerful tool in assessing the risks of using such any given recipient strain in an industrial process.
I next pointed out the importance of clarifying that MCANs for contained manufacturing would be evaluated and regulated in a manner different from TERAs or MCANs for open-pond uses. EPA’s guidance and the draft “Considerations” document does specify in several locations which provisions are applicable to open ponds as opposed to contained uses, but EPA should be sure that such guidance is appropriately given throughout the document, for example, clarifying that information on “Monitoring” should primarily be applicable only to proposed open pond uses, and would be applicable to contained uses only in extraordinary situations.
EPA had asked the question of whether there were features of contained photobioreactors that posed potential hazards. I pointed out that it is not the reactor itself that should be considered potentially “hazardous”, because it is the characteristics of the strain that would dictate potential environmental risks. The more proper question to ask is “What information about a containment system should be provided to assess the potential for release of modified algae from the system?” In other words, EPA’s goal should be to develop guidance to help applicants identify and provide information EPA needs to assess the integrity of the reactor, and in fact EPA intends that such guidance would be included as a significant component of the “Considerations” document. Section VI of the draft “Considerations” document, particularly Section VI.B for photobioreactors, seems to be a comprehensive and mostly appropriate listing of such requested data, in that it focuses on information unique to photobioreactors, the materials from which they are constructed, and the manner in which they are used to grow, harvest and handle the modified algae or cyanobacteria.
In both the DGA and Joule comments, I stressed the strong opinion that existing biotechnology laws and regulations around the world are generally sufficient to apply to the potential applications of “synthetic biology” that are contemplated in the near future, and that data requirements under such regulations, including EPA’s TSCA biotechnology regulations, do not need to be substantially changed in order to provide effective oversight over synthetic biology. I cited the findings of several governmental or international bodies that have all come to the conclusion that, at least for the foreseeable future, existing laws and regulations around the world are sufficient to provide for adequate risk assessment and risk management of proposed commercial uses of synthetic biology, and I provided copies of my slides from my July 2015 presentation at the BIO World Congress addressing this very point.
Finally, in my comments on behalf of DGA, I addressed an issue about which some ambiguous comments were made at the September 30 public meeting. That pertains to some confusing terminology in the Part 725 regulations regarding whether the “Contained Structure” exemption for R&D activities applies to commercial entities, and whether the definition in the regulations of “Commercial R&D” applies to companies in a way that might render the exemption unavailable. In my consulting practice I’ve encountered confusion over these issues, and so in my comments I asked EPA to clarify the widespread view within industry that the “Contained Structure” exemption does indeed apply to companies as well as non-profit researchers, provided the appropriate conditions are met.
Please contact me if you would like a complete copy of the DGA comments, which include the Joule written comments in their entirety.
D. Glass Associates, Inc.is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and, except as indicated above, do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.
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