There have been some interesting developments in the early months of 2024 in Argentina, where the Ministry of Agriculture has issued a series of approvals for the use of multiple strains of modified Saccharomyces cerevisiae yeast for use in ethanol fermentation and in distillers’ grains for use in animal feed. As of this writing, these approvals have involved proprietary strains from at least four different companies, and appear to have resulted from a concerted effort by the country’s recently-appointed Secretary of Agriculture.
Argentina has had a well-developed biotechnology regulatory structure for some time, although interestingly the country does not appear to be a signatory to the Cartagena Protocol. In recent years, the government has reviewed and approved a large number of field tests and commercialization requests for GMO plants. The government has issued numerous regulations governing several aspects of agricultural biotechnology, and the one that was deemed to apply to modified yeast strains is Resolution 763/2011. This Resolution states, in part, that “Any release into the agroecosystem of GMOs that do not have commercial approval will in all cases require prior authorization from the SECRETARY OF AGRICULTURE, LIVESTOCK AND FISHERIES of the MINISTRY OF AGRICULTURE, LIVESTOCK AND FISHERIES” and “The obligations and responsibilities arising from the authorization granted for the release of regulated GENETICALLY MODIFIED ORGANISMS (GMOs) to the agroecosystem include all the stages involved in said process, that is, the handling of the materials both from entry into the country, such as during handling and use, storage and until final disposal” (both are Google translations from the original Spanish). The use of modified yeast strains in ethanol fermentation could be regulated as a “contained manufacturing” use, but Argentina does not appear to have a regulation that specifically covers industrial uses of modified microorganisms. In any event, the fact that inactivated biomass of these strains from the ethanol fermentations is intended to be used in distillers’ grains as animal feed, causes these strains to require approval under Resolution 736/2011.
Within the first weeks of 2024, the government, through the National Commission on Agricultural Biotechnology (Spanish acronym CONABIA) has approved at least the following strains of S. cerevisiae for use in ethanol fermentation and in distillers’ grains:
DANISCO: Saccharomyces cerevisiae strains GICC03486 (GPY10009), GICC03506 (GPY10023), GICC03578 (GPY10168), and GICC03588 (GPY00603), approved December 29, 2023 and January 4, 2024, via Provisions 3/2023 and 6/2024. These strains are said to have an improved ability to produce bioethanol from grain fermentation. According to an article in Ethanol Producer magazine (and as also reported in Advanced Biofuels USA), utilization of the approved yeast strains is expected to improve ethanol production yields, reduce transportation costs, decrease carbon emissions, and mitigate the deterioration of transportation infrastructure.
LALLFERM SA (Lallemand): Saccharomyces cerevisiae strain Fermboost MR, approved via Provision 1/2024, as announced on January 26, 2024. According to the announcement, “The product will be used in the production of bioethanol from corn cultivation. This strain stands out for its ability to efficiently convert corn starch into simple sugars and thus optimize the performance and productivity of the ethanol biosynthesis process.”
NOVOZYMES BIOAG SA: Saccharomyces cerevisiae strain SCY011. As announced on March 6, 2024, the government granted permission to market this new genetically modified yeast to produce bioethanol from corn. It was said to be the sixth genetically modified microorganism authorized by the Secretariat since the beginning of 2024. Approval was granted via Provision 9/2024.
IFF: SYNERXIA® yeast. It was announced on February 28, 2024 that the Argentinian government granted IFF approval to commercialize genetically modified yeasts designed to improve corn ethanol production efficiency. The SYNERXIA® yeast strain is said to enhance corn conversion rates into bioethanol by up to three percent. As of today’s writing, it doesn’t appear that the government has yet published the official announcement of this approval.
These decision documents generally state explicitly that biomass resulting from use of the strains in ethanol fermentation can be used in animal feed.
It is interesting that the government issued these approvals in close proximity to each other, and it’s apparently no coincidence. As reported in reported in a very nice article on the Danisco approvals in Advanced Biofuels USA, the Argentinian government changed hands in December 2023, and although the various regulatory reviews for these products had been undertaken under the previous administration, the announcements of the approvals were all made under the auspices of the incoming Secretary of Agriculture Fernando Vilella. The article reports that Vilella has been a longstanding supporter of biofuel development in Argentina and of the bioeconomy in general. The article said that Vilella intended to change the name of the Ministry to the “Ministry of Bioeconomy”, which has evidently been done since that name appears in some of the more recent approval announcements.
This is a welcome positive development for the Argentinian bioethanol industry, as well as to these four companies. These strains have likely been approved for use elsewhere in the world, particularly in Brazil: for example, two of the Danisco strains were approved in Brazil in February 2019, and modified strains from four companies, including Novozymes strain SCY011, have been reported by Jacobus et. al 2021 to have also been approved in Brazil as of 2021. (In a 2014 blog post, I summarized some of the earliest modified strains to be approved in Brazil).
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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