From time to time, I have posted updates on the blog regarding recent submissions to the U.S. Environmental Protection Agency under its biotechnology regulations under the Toxic Substances Control Act (TSCA). In a post a few weeks ago, I described recent activity with the filings of Microbial Commercial Activity Notices (MCANs) under these rules – the notifications required before the commercial use or importation of certain genetically modified microorganisms in the manufacture of chemicals, fuels, enzymes and other applications not regulated elsewhere in the federal government. In today’s post, I’m turning my attention to a different application under these rules – TSCA Environmental Release Applications (TERAs), which are required for any proposed field testing or other outdoor experimentation of a microorganism that falls under the jurisdiction of the rule.
I last reported on approved TERAs a few years ago, and so in today’s post, I’m presenting brief overviews of those TERAs filed and approved since my earlier post. That prior post reported on two TERAs submitted by Arizona State University for field tests of modified algae, and so today I begin with a series of applications submitted by Synthetic Genomics, Inc. (now known as Viridos, Inc.) for field tests of modified algae strains as part of its program to develop processes for photosynthetic production of biofuels.
TERA R-19-0001 was submitted in April 2019 and described a proposed field test involving a model algal organism, a proprietary Parachlorella sp. strain, modified with a reporter gene. According to the company’s submission, the purpose of the test was to “establish baseline environmental conditions in and around the test facility, and to evaluate and confirm the sufficiency of control and monitoring equipment and techniques developed for this and other similar outdoor R&D programs,” with the goal of “establish[ing] a more predictable framework for future EPA reviews of outdoor algae R&D activities at our test facility”. The TERA was approved in June 2019, and the test took place at the company’s California Advanced Algae Facility (CAAF) near Calipatria, California. As part of the testing, the company proposed an extensive program of air, soil and water monitoring to detect the potential for the subject microorganism to be dispersed from the test pond.
This initial TERA was followed by two others from Viridos, proposing more extensive field testing of proprietary strains of modified algae at its California research station:
TERA R-20-0001, submitted May 2020, which proposed open-pond testing of multiple green microalgal strains engineered for enhanced lipid productivity, approved July 2020.
TERA R-21-0002, submitted March 2021, proposing open-pond testing of three green microalgal strains engineered for enhanced lipid productivity, approved May 2021.
Each of these TERAs proposed progressively larger-scale testing of proprietary algae strains at the CAAF facility. I have briefly described the Viridos TERAs and field tests in my October 2022 presentation at the Algae Biomass Summit.
For full disclosure, please note that I have consulted for Viridos on aspects of TSCA compliance, including assisting in the review of their second and third TERAs prior to their submittal to EPA.
In addition, recent years have seen the following TERAs submitted for agricultural field tests.
TERA R-20-0002, submitted November 2020, proposed the field testing of three Alphaproteobacteria strains modified with a tracer marker integrated on the chromosome. The marker was apparently a bioluminescent protein that was to be used to investigate the extent of microbial colonization of plants. The organisms were proposed to be sprayed onto the leaves of soybean plants. Although much of the TERA is redacted, including the name of the applicant, it states that the proposed test is part of a research effort aimed at developing biocontrol or biostimulant products. Interestingly, the TERA indicates that products ultimately arising from this program would likely be regulated by EPA under the pesticide law FIFRA, but that the proposed research activities, prior to identification of candidate products, would be subject to TSCA jurisdiction. This TERA was approved in January 2021.
TERA R-21-0001, submitted February 2021 for field testing of as many as eight Bacilli strains engineered to affect nitrogen production. The purpose of the test was to evaluate the engineered strains’ ability to effect nitrogen uptake in corn plants. The TERA described the proposed field test and the methods that would be employed to detect any possible spread of the organisms beyond the test plot into border rows The identity of the submitter, as well as the identity of the species of organism, was claimed as confidential. The TERA was approved in April 2021 for tests intended to be carried out in the spring of 2021.
TERA R-22-0002, submitted February 2022 also proposed field testing of a number of Bacilli strains engineered to affect nitrogen production, to evaluate the engineered strains’ ability to effect nitrogen uptake in corn plants. Although the identity of the submitter was claimed as confidential, it appears that this submission is from the same company as TERA R-21-0001. The TERA was approved in March 2022 for tests intended to be initiated in the spring of 2022.
TERA R-23-0002, submitted January 2023 proposed the field testing of a Bacilli strain engineered with a genetic “barcode” which would enable its detection in the environment, e.g. by PCR assays. The purpose of the test was to allow molecular detection of the microorganism’s ability to colonize plants. The TERA was approved in March 2023 for tests intended to be initiated in the spring of 2023.
TERAs would be required for outdoor testing of certain modified microorganisms intended for such uses as open-pond fuel or chemical production, bioremediation or uses of nonpesticidal microorganisms such as biofertilizers. Please contact David Glass if you have any questions regarding the applicability of EPA’s biotechnology regulations to your proposed activity.
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-five 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. In addition to his work as a consultant assisting industrial biotechnology companies prepare for and comply with government regulations, he has served as Director of Regulatory Affairs for Joule Unlimited Technologies and Vice President of Government and Regulatory Affairs for BioTechnica International. Dr. Glass has extensive experience with the biotechnology regulations of the U.S. EPA and other agencies, and has coordinated or assisted in the preparation and submission of 18 successful Microbial Commercial Activity Notices and several other biotechnology submissions in the U.S. and other countries. Dr. Glass holds a B.S. in Biological Sciences from Cornell University and a Ph.D. in Biochemical Sciences from Princeton University.
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