Public Meeting and Opportunity for Public Comment on EPA's Draft Algae Guidance for the Preparation of TSCA Biotechnology Submissions

October 27, 2016
Old Main Building at Arizona State University
400 East Tyler Mall
Tempe, AZ
8:00 am – 12:00 noon MST

Background

EPA has overseen products of the biotechnology industry since 1986, with formal requirements for oversight of certain genetically engineered microorganisms (GEMs) issued first in 1997. Accompanying this 1977 biotechnology rule, (Microbial Products of Biotechnology, Final Regulation under the Toxic Substances Control Act), EPA provided a guidance document for those required to notify EPA of planned production or release of these GEMs under that regulation. The guidance is called "Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms" ('Points to Consider'). EPA found that due to new technological advances and given the current and proposed use of microorganisms subject to TSCA that an update to the 1997 'Points to Consider' guidance document was needed. The 1997 'Points to Consider' addressed data needs for the kinds of technologies expected to be prevalent at that time (e.g. closed system fermentation, biofertilizers and bioremediation). Since then many new organism categories (such as algae, protists, and viruses) have begun to be developed, or are moving toward production. In addition, there have been tremendous advances in genetic engineering techniques unknown in 1997, such as RNA interference, gene editing techniques such as CRISPR/Cas9, the use of chemically synthesized genetic material and creation of biological "parts", that allow for microorganisms to be used in new and novel ways. Therefore, EPA hosted a workshop in September 2015 to solicit input from the public and has developed an updated draft guidance document to accommodate the new uses and products derived from GEMs that were not anticipated in 1997 but are subject to TSCA oversight.

It is important to note that EPA's oversight of biotechnology, as originally expressed in the 1986 Coordinated Framework for Regulation of Biotechnology, as well as the associated Update released September 2016, is case-specific and based on the characteristics of the resultant microorganism (the product), not on the technology used to construct the microorganism (the process). Thus, EPA's need to update this guidance is not due to a perceived a priori difference in risk associated with these new technologies (processes). It is simply an effort to help submitters prepare required notifications for products generated from these new technologies, in a manner beneficial to them and the Agency, for cases where existing guidance is absent or inappropriate.

Relevant Historical and Current Documents

• 1986 Coordinated Framework
• 1992 Framework
• 1997 Points to Consider
• Draft Algae Guidance for the Preparation of TSCA Biotechnology Submissions

Purpose

The primary purpose of this public meeting is to obtain technical commentary relevant to EPA's Algae Guidance for the Preparation of TSCA Biotechnology Submissions guidance document. As with the September 2015 workshop, this meeting will coincide with a major technical conference being held locally with the prospect of drawing and promoting the participation of individuals directly involved in the development of algal products.

EPA anticipates that algae experts, genetic engineers, and other members of the public interested in algal-based biotechnology products will attend and provide invaluable commentary addressing scientific and technical topics found in the Algae Guidance developed by EPA. The bulk of this meeting's available time will be devoted to providing speakers an opportunity to comment on EPA's Algae Guidance, relevant to the risk assessment of algal-based products, some of which will be genetically engineered using techniques beyond traditional recombinant DNA technologies addressed in the 1997 guidance document.