On October 27, 2016, the U.S. Environmental Protection Agency convened an open meeting to begin soliciting public comment on its recently-issued draft guidance for the preparation of TSCA biotechnology submissions involving genetically modified algae or cyanobacteria. The agenda for the meeting can be found here, and the Draft Algae Guidance can be downloaded here. The charge questions and other supporting material for the meeting are available here. The meeting also served as the kickoff for a public comment period that runs until November 30, 2016.
The meeting took place at Arizona State University in Tempe, following the end of the Algae Biomass Summit which took place in Phoenix earlier that week. I attended the meeting via the live Web streaming that EPA and ASU arranged. The following is a brief summary of what I felt were the more important issues discussed.
The meeting began with brief presentations by EPA staff on the TSCA biotechnology regulatory program, the process by which EPA conducts risk assessments under the program, and finally an overview of the contents of the Draft Algae Guidance document. This was followed by three opportunities for public comment: the first focusing on the Charge Questions that addressed algae ecological effects; the second focusing on the more general Charge Questions; and the third featuring comments on the Draft Algae Guidance itself.
Overall, I felt that this meeting featured more substantive discussion than what I recall was the case at the Agency’s September 2015 Washington, DC public meeting that kicked off their efforts to provide guidance for algae submissions under TSCA. Several commenters at last week’s meeting offered substantive observations or critiques of the Draft Algae Guidance document, and there were also some (predictable) comments from industry critics regarding safety and risk assessment. Among the key issues discussed:
- There was some discussion of the impact of the Lautenberg TSCA reform legislation on the biotech program. EPA staff summarized the major impacts as the requirement that the agency issue definitive statement on the results of TSCA risk assessments (as opposed to previous practice of simply “clearing” PMNs and MCANs without making a statement on the assessed risk); and the need for the agency to make more information on such decisions available to the public (i.e. the policy of “transparency” which came up often in discussions). EPA has already begun implementing both these directives in its ongoing practice under TSCA.
- Comments from industry critics (Friends of the Earth, Biofuel Watch, Consumers Union and the International Center for Technology Assessment) focused on the their contention that the environmental effects of GE algae were unpredictable, the alleged inability to contain the organisms even when cultivated in contained photobioreactors, and the critics’ desire to see EPA regulate all applications of synthetic biology under TSCA, even those limited to single nucleotide changes. Some suggested that EPA needed to broaden their risk assessments to consider the entire life cycle of the product and commercial process, rather than just the microorganism, although EPA staff felt this was beyond their authority under TSCA.
- The critics were also unanimous in criticizing the extent of confidential information that is allowed in TSCA filings, which is then redacted in public documents.
- Several of the critics also commented on EPA’s definition of “new microorganism” which limits its TSCA oversight to intergeneric organisms and thus excludes modified microorganisms which do not contain coding DNA from outside the host organism genus. Several speakers contrasted this definition to Footnote No. 1 in the OSTP July 2015 memo that kicked off the Coordinated Framework Modernization effort in which “biotechnology products” was defined more broadly. EPA staff explained that TSCA applies only to “new chemicals” that are not naturally occurring, and so the biotech program under TSCA was limited to “new microorganisms” that were judged to have been unlikely to have emerged through natural recombination at any time in evolutionary history.
- Although the industry critics generally offered comments at every opportunity on a variety of topics, some of their comments showed a surprisingly poor level of knowledge about the TSCA regulations and their background. Several critics were confused about how the tiered exemptions work and were afraid that EPA would act unilaterally and rashly to add algae species to the exempt list (something EPA could do only through rulemaking, and only after conducting an exhaustive risk assessment).
- There were a handful of academic scientists who offered substantive remarks on specific risk assessment issues. A speaker from Oklahoma State University made an interesting point, that algal blooms are usually a function of the prevailing environmental conditions rather than being determined by the biology of the strain(s) causing the bloom, so that a GE algae that escaped containment would not necessarily form a bloom itself and in fact would need to compete with better-established algae species and strains that were already adapted to the environment and perhaps even selected for bloom-forming traits.
- Several speakers touched on substantive scientific topics about the content of the newly-released draft guidance document for algae, but it was difficult to have much to say about that guidance in a short 3-minute public statement, particularly when it had only been available for public review and comment for a short time.
- Several industry speakers (e.g. representing Algenol, TerraVia, Synthetic Genomics, BIO and ABO) had kind words to say about EPA staff and their diligence in administering the regulations, and several stressed that going through the MCAN process is not easy and that EPA gives MCANs a thorough review. Industry speakers defended the need for strong CBI protection, while arguing that confidentiality claims are not necessarily asserted for the most important environmental data.
- Industry speakers generally thought that the draft guidance was comprehensive and covered the major topics, although some worried that its comprehensiveness may give some observers the erroneous impression that all the data would always be needed for all submission. Suggestions were made to possibly institute tiered requirements depending on the familiarity of the host strain, and one industry speaker even suggested adding common algae strains to the list of hosts potentially qualifying for the tiered exemptions, a comment unlikely to be adopted, as discussed above.
Overall, I felt it was a useful and substantive meeting, and I think EPA got some useful feedback. Public comments will be entertained until November 30, 2016, after which the agency hopes to finalize the algae guidance document. I am planning to submit comments before this deadline, and I’ll report on future developments in the blog.
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/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.