On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs to ask and answer when it receives a Microbial Commercial Activity Notice (MCAN) for GE algae. Dr. Morris discussed how this workshop will contribute to EPA's broader effort to update the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms document that relates to other GE microorganisms, as well as the update to the federal Coordinated Framework on the Regulation of Products of Biotechnology. While updating the framework will assist EPA in handling risk assessments for GE algae, regulation will continue to be risk-based and determined on a case-by-case basis.
Members of EPA's biotech review team discussed aspects of MCAN review and pointed out particular areas where EPA seeks input, in particular:
- Taxonomy of algae;
- Propensity to transfer genetic material to other species;
- Ability to produce toxins or allergenic effects;
- How the growth rate and forms (unicellular or filamentous) might relate to exposure;
- Survivability of GE algae in the wild; and
- Propensity to out-compete wild populations of algae, and organismal control mechanisms.
The panel, as well as stakeholders, commented on how algae are different than traditional industrial microbes in some significant ways:
- The organisms are not as well studied, largely because, unlike bacteria and fungi, they have only recently been used for industrial production.
- Inactivation methods are quite different because of the protective cell walls that algae have, that most microbes lack.
Dr. Morris also made it clear that this meeting is just the beginning of the conversation. EPA continues to seek input from stakeholders on algae, in particular, and other GE organisms as part of EPA's effort to update the regulatory framework for GE organisms. Draft Charge questions are available on the workshop website, speaker presentations can be accessed through the meeting agenda webpage, and the deadline for written comments is October 31, 2015. More information on EPA's development and use of biotechnology is available in B&C's memorandum EPA Posts Information on Biotechnology Algae Project.