About Mascoma
Mascoma’s technology harnesses the power of modern biotechnology (genetic engineering) which has opened doors to develop revolutionary new brewing yeasts which target production benefits that previously were unattainable with conventional brewing yeast. In 2019 Lallemand and Mascoma released Sourvisiae®, the first engineered brewing strain in dry form that is broadly released in the US brewing market which was made by homologous recombination, a natural repair technique that yeasts employ to repair breaks in their DNA.
Moving forward, Lallemand and Mascoma are continuing to develop innovative, high-tech brewing solutions to address a wide range of production challenges. Explore our Education section and Safety Statements to learn more about how we make engineered brewing strains, and, most importantly, how we ensure they are safe for the consumer!
In the United States, the FDA sets safety standards for GM foods, feeds, and ingredients by assessing the risks for human, plant, and animal health, as well as environmental safety throughout production, processing, storage, and application of the products. The FDA uses the GRAS (Generally Recognized As Safe) review process. The GRAS conclusion may be “self-affirmed” by the manufacturer, reviewed by a scientific panel, and/or submitted as a GRAS notification to the FDA.
What is in a GRAS Document?
The GRAS conclusion is based upon scientific procedures and requires the same quantity and quality of scientific evidence as would be required to obtain approval of any food additive.
A thorough evaluation of the genetically modified organism is documented in a dossier which provides extensive descriptions of how the product was developed, how it will be used, how it will be manufactured, a history of safe use and dietary exposures of any byproducts or coproducts from both manufacturing and industrial processing.
This should include (but not limited to) scientific data regarding the toxicity and allergenicity of the organism and its resulting products, confirmation on the absence of antibiotic genes (if used during the process), inactivation studies and confirmed genetic stability.
It is important to note that under the GRAS qualification, for foods and food ingredients, the product is considered FDA compliant if the FDA does not have concerns with the reviewed documentation, but it is not considered “FDA Approved” as that designation is reserved for products regarding health claims.
Sourvisiae® has been determined by Mascoma LLC to be Generally Recognized As Safe (GRAS) for use in beer production based on scientific procedures and conforms to the federal regulations in 21 CFR § 170.30(a) and (b).
To find out more about Mascoma and the science behind our genetically engineered strains, please click here.
Intro to GE
In the United States, the Food and Drug Administration defines a Genetically Modified Organism (GMO) as “a plant, animal, or microorganism that has had its genetic material (DNA) changed using technology that involves the specific modification of DNA, including the transfer of specific DNA from one organism to another” (1).
Different regulatory bodies worldwide define genetic modification in different ways, with some considering any change to the DNA of an organism as a genetic modification.
The World Health Organization (WHO) defines GMO as an organism that is altered through a process that cannot occur in nature. This definition helps separate those modifications that come through conventional methods, such as forced hybridization, from modifications that are a result of modern biotechnology tools. Lallemand Brewing is focused on solutions for all – GE, hybridization and bioselection.
What is Genetic Engineering
Genetic Engineering is an explicit term that describes the modification of the DNA through modern biotechnology. Notable examples of genetic engineering include homologous recombination and CRISPR which are widely used in academic and industrial science.
The following table below provides definitions for some common terms.
Table 1. Genetic engineering related nomenclature, acronyms, and definitions. Definitions are derived through regulatory and academic literature within the context of this review. This table is split into General Nomenclatures, Regulatory Nomenclature, and Biotech Nomenclature.
General Nomenclature
| Acronym | Nomenclature | Definition |
| BE | Bioengineered | A product or organism resulting from GE technology. |
| Cisgenic Modification | Where genetic material from sexually compatible species is inserted into the genome of a host organism. This does not result in the expression of novel traits, and generally does not impact the fitness of the organism itself. | |
| GE | Genetically Engineered OR Genetic Engineering | Term used to describe an organism that has been modified using biotechnology. Often interchanged with “GMO”. |
| GMO | Genetically Modified Organism | Vernacular term and initialism used to describe organisms that have undergone some form of heritable genetic modification. Typically associated with transgenic modification. |
| Transgenic Modification | Where genetic material from sexually incompatible species is inserted into the genome. This typically will result in expression of novel traits and may impact the fitness of the organism itself. | |
| rDNA | Recombinant DNA; Recombinant | A combination of DNA elements from different genes within a species, or DNA elements of different species to generate new genes |
| Heterologous | Derived from a different species |
Figure adapted from: Genetically Engineered Yeast – A Review of Terminology, Science, and Regulation, MBAA TQ: 2022, 59: 3.
References
(1) Food and Drug Administration: https://www.fda.gov/food/consumers/agricultural-biotechnology#:~:text=A%20GMO%20(genetically%20modified%20organism,from%20one%20organism%20to%20another.
United States Department of Agriculture. USDA APHIS | Biotechnology Regulations. https://www.aphis.usda.gov/aphis/ourfocus/biotechn 2020.
United States Department of Agriculture. Biotechnology | USDA. :https://www.usda.gov/topics/biotechnology 2022.
United States Department of Agriculture. List of Bioengineered Foods. :https://www.ams.usda.gov/rules-regulations/be/bioe 2022.
World Health Organization. Food, Genetically Modified. https://www.who.int/health-topics/food-genetically-modified#tab=tab_1
Browning, Molly; Burns, Laura; Rice, Chaz; Shayevitz, Avi, “Genetically Engineered Yeasts – A Review of Terminology, Science, and Regulation,” MBAA TQ vol 59:3, 2022 pp136-143.