Regulatory issues for genetically modified animals

Abstract

Precision genetics and breeding have the potential to meet the agricultural needs and goals of the world in the 21st century. These needs include increasing the efficiency of production of animals and improving their products with minimal impact on the environment. The USA is the major innovator in genomic science and the acknowledged leader in formulating policies to regulate genetic applications in medicine and agriculture. However, governments worldwide have been exceedingly reluctant to support the introduction of genetically modified (GM) animals into agriculture. Regulatory policies have stagnated due to legal guidelines that could not anticipate the needs and solutions that are evident today. This must change if we are to maintain planetary integrity. I propose a new, market-based regulatory model for GM livestock that has both a strong scientific foundation and has worked for 10000 years. The model is similar to that for information technology in which specific algorithms drive computer and cell phone applications. Genome engineers write genetic algorithms that drive the traits in biological organisms. Accordingly, GM products should be viewed in terms of their use and public benefit rather than by limitations to the genetic programing coming from a few highly vocal groups. Genetic algorithms (Genapps) of the 21st century will include not only introduction of synthetic genes, but also complete natural and synthetic biochemical pathways to produce agricultural products that are maximally efficient, healthy to humans and animals, and sustainable in an era of changing climates while avoiding environmental degradation.

Keywords

algorithms / editing / FDA / GMO / recombinant DNA / USDA

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Acknowledgements

I am grateful for the thoughts and insights of many colleagues over the past three decades of working with transgenic animals. Drs. Mark Walton, Tad Sonstegard, and Elena Aronovich were kind enough to make suggestions even if dubious that my proposal would be accepted by anyone. I am appreciative of many other colleagues who have shared their thoughts with me on earlier proposals and reviewers who corrected errors and made important constructive suggestions. I am especially appreciative of regulators in the EPA, FDA and USDA who have listened to my views and offered their points of view while doing their best to comply with federal legal restrictions, politicians, and a diverse public.

Compliance with ethics guidelines

Perry Bradbury Hackett is a co-founder and stockholder in three genome-engineering based companies, Discovery Genomics (acquired by Immusoft, Inc.), Recombinetics, Inc., and NovoClade, Inc. He declares that there is no conflict of interest or financial conflict to disclose.

This article is a review and does not contain any studies with human or animal subjects performed by the author.

RIGHTS & PERMISSIONS

The Author(s) 2020. Published by Higher Education Press. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0)