From time to time, I’ve posted analyses of recent Microbial Commercial Activity Notices (MCANs) reviewed and received by the U.S. Environmental Protection Agency (EPA) under its biotechnology regulations (40 CFR Part 725). Since the 2016 enactment of the Lautenberg Amendments to the law on which these regulations are based, the Toxic Substances Control Act, or TSCA, EPA has changed the way approved MCANs are posted on the agency’s website. Some of these changes are for the better – approvals are posted much more quickly after the approval date, as opposed to the old system where approval lists were often many months out of date. However, the new format of the approval listings has made it a bit harder to learn much of any value regarding the microorganisms covered by the MCANs and their company applicants.
One page on the EPA website is an “MCAN Table”, which is dedicated to the biotechnology program and which lists in one place all the MCANs approved since the June 2016 amendments, with 200 entries as of April 10, 2023. However, this page does not show any information other than the submission and approval dates, and in particular does not identify the applicant (where that is not confidential) or provide the generic (non-confidential) names of the organisms. A more informative page is the “Chemicals Determined Not Likely to Present an Unreasonable Risk” page, which includes biotechnology submissions along with all other submissions for chemical substances under Section 5 of TSCA, and includes 547 entries as of April 10 submitted since June 2016. This page is searchable, and by searching for the MCAN prefix “J”, it’s possible to develop a list of MCANs approved since 2016. Although this list does not identify the applicants, working from this listing is advantageous because each entry includes the generic name of the microorganism with a link to EPA’s decision document for each MCAN. Although the decision documents rarely contain any information specific to the organism that is the subject of the MCAN, this table provides more information than the “MCAN Table” mentioned above.
The latter table allows the following to be said regarding approved MCANs submitted during Fiscal Years 2021, 2022 and 2023 to date (i.e. submitted since October 1, 2020). As of April 10, 2023, of those MCANs submitted in this time period, 50 were approved (note that when consolidated MCANs are filed, each of the strains is assigned its own MCAN number, so these 50 assigned MCAN numbers correspond to about 24 discrete submissions). Of the fifty, 23 were identified in the generic organism name as covering genetically modified Saccharomyces cerevisiae, while the other 27 were for other microbial species or were for MCANs for which the identity of the species was claimed as confidential (although several of these were for “modified yeast” strains, some of which may also be S. cerevisiae). The listings include a “generic use” for the organisms, and among the uses cited were biofuel production, production of chemicals, enzymes or other proteins, nucleic acids, or agricultural products. (For full disclosure, I should add that I prepared or assisted in the preparation of 10 of these 24 submissions on behalf of several clients).
There isn’t much more that can be said about these MCANs without obtaining the nonconfidential copies of the filings from EPA’s public information offices. However it is interesting that these figures show that EPA is receiving and approving approximately 20 or more MCANs per year, which is perhaps a bit below the historical peak, but is still a decent size workload. It’s also interesting that many of the S. cerevisiae MCANs specifically reference the production of biofuels, at a time when industry interests are shifting towards production of bio-based chemicals with less emphasis on products like biofuels that generally have lower profit margins.
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.
Bio-Based Chemicals and Fuels: Business, Policy and Regulation 