In the previous blog post, I reported that EPA announced that it was initiating a project to examine and promote “public dialog” about the development and use of genetically modified algae and cyanobacteria, including organisms modified by synthetic biology, intended for industrial purposes including those subject to the Agency’s TSCA biotechnology regulations. The Agency’s plans have become more clear, and the public meeting mentioned in EPA’s late July announcement has now been scheduled for Washington, DC on September 30, 2015.
Shortly after the initial announcement, EPA reposted a revised project description on its website, clarifying that the project would primarily be focused on developing data to allow assessment and monitoring of uses of modified algae and cyanobacteria. The modified description can be found here on the EPA website. Further information was then made available when the Agency received approval to announce its plans in the Federal Register, in an announcement that appeared on August 25, which formally announced that a public meeting entitled “Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae” would be held in Washington on September 30, 2015. At the same time, the Agency created a docket page on the government’s regulations.gov website, and EPA posted the agenda and the “Charge Questions” for the September 30 public meeting for accessing and downloading on this docket page.
As it turns out, the discussion questions in fact touch on synthetic biology (“advanced genetic engineering”) as well as algae biology (“algae mass production”). The questions have been grouped into two categories (along with a third, inviting questions on topics not covered in the stated questions). The six substantive Charge Questions can be summarized as follows (the specific, more detailed questions can be found in the posted documents):
Algae Mass Production: Intrinsic Hazards and Effects Data.
- What hazards may be associated with the mass production of algae, other than toxins and harmful algal blooms?
- What data are available to allow risk assessment of proposals for algal mass production?
Algae Mass Production: Exposure
- What potential hazards are posed by the different containment systems (e.g. photobioreactors) being considered for industrial use of algae, and how should such hazards be evaluated?
Advanced Genetic Engineering
- What information should be included in EPA submissions on the construct used to develop a new organism which has been altered using synthetic biology techniques?
- How can the predicted function of a genetically engineered construct be shown to be limited to the purpose for which it was designed (e.g. for genes known to encode multiple functions)?
- In submissions involving synthetic xenonucleic acid-based constructs, what biological containment methods are best employed?
I will be attending EPA’s public meeting next month, and between now and then I’ll be developing some detailed comments in response to these questions in conjunction with one or more of the companies for whom I consult. I plan to post such comments and other observations about these questions on the blog, and I will also report on the EPA meeting after it takes place. In the meantime, I’d be happy to answer any questions anyone may have about this process, EPA’s intentions, and how it fits into the “big picture” of EPA’s biotechnology regulatory program.
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 do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.