Biotechnology Should Prefer Regulatory Pathways to Catalyze The Bioscience Revolution

Lone Dybdal Nilsson, VP of Applied Research in agriculture and Industrial Bioprocessing, Novozymes

U.S. regulations must be updated to fully leverage biotechnology for a better world. Using the tools of nature to unleash its power is a strong path for providing biological answers for better lives in a growing world and to address the sustainability challenges present. Greater regulatory certainty for new biological products for farming is needed to bring bio-solutions to fruition.

In nature, microorganisms mutate and exchange genetic information continuously, to adapt to the challenges they face while surviving in their changing environments. Such continuous adaptation can serve to improve capabilities like utilization of new sources of nutrition, or ability to overcome threats from other microorganisms.

With modern sequencing technology microbial genomes and small alterations can be mapped with extreme accuracy which enables specific alteration of microbial genomes. In the past decades, methods for specific and controlled modification of genetic information in microorganisms have been employed with an increased focus on their role in unlocking sustainability using bioscience solutions.

For example, CRISPR-Cas techniques for gene editing have been implemented in many laboratories around the world. These are things that microorganisms do which also applies to nature, but in some regulatory schemes they are subject to extreme scrutiny in an approval process that is not clear or aligned between agencies. This is done to a degree that is limiting access to the benefits of transformative climate-smart solutions for farmers and consumers.

With modern sequencing technology microbial genomes and any small alteration can be mapped with extreme accuracy, and this enables highly specific alteration of microbial genomes

Gene editing tools are highly effective for removing genes that could lead to expression of harmful metabolites or incur inappropriate resistance in an organism (like e.g., antibiotic resistance genes). They are also useful for enhancing a microorganism’s expression of compounds that it expresses to grow and defend itself in nature (e.g., enzymes), or adding beneficial capabilities from other microorganisms, leading to higher efficacy in the application.

With such techniques, controlled modification of microorganisms can be used to strengthen the beneficial impact of biological solutions. This includes addressing societal needs like breaking down waste material (for recycling and less landfill) or strengthening the gut health of a chicken or the nutrition uptake of a corn plant (to increase production yield and reduce the use of antibiotics and chemical pesticides in the food chain). In other words, it is possible to accelerate an otherwise slow genetic evolution of microorganisms, for the benefit of human health, and for the benefit of our planet.

Our world needs all the help it can get. We strongly support efforts to update the regulatory framework for genetically modified microorganisms across all sectors. Regulatory uncertainty stymies industry innovation. But the reverse–a nimble, fact-based approach– enables the government to be a full and agile partner able to take advantage of emergent, beneficial and safe biotechnological solutions to address global challenges.

Only with a progressive and science-based regulatory framework and a framework that is consistent between the main agencies with authority on agriculture (USDA, FDA, EPA) can the U.S. deploy the opportunities of biotechnology.

Let’s demystify genetic evolution and make the world a better place sustainably.

Biotechnology Should Prefer Regulatory Pathways to Catalyze The Bioscience Revolution

Lone Dybdal Nilsson, VP of Applied Research in agriculture and Industrial Bioprocessing, Novozymes

Biotechnology

Agile