The United States Food and Drug Administration has announced it will be deciding how to regulate the use of CRISPr ((clustered regularly interspaced short palindromic repeats-Cas) gene-editing technology applied to plants and animals.
The announcement indicates the Trump administration will put the emphasis on using the technology to advance innovation.
That would be a change from the ulta-cautious approach to regulating GMOs (genetically-modified organisms) which generally involves the transfer of one or more genes from one species to another.
An example is the transfer of a gene found in bacteria to corn so it’s resistant to glyphosate (Roundup) plant killer.
Current examples of CRISPr technology are research projects to develop dairy cattle that have no horns, male pigs that never reach puberty so can be grown to market weight without castration and pigs immune to two troublesome viruses, PRRS (Porcine Reproductive and Respiratory Syndrome) and TGE (Transmissalbe Gastroenteritis).
In these examples, one gene is knocked out of action, eliminating the substance it is responsible for producing.
In the case of the swine viruses, it is specific enzymes the virus needs to be able to attach to and enter cells.
The FDA said it plans to issue separate sets of guidelines for animals and for plants.
It said the guidelines will “outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission.“
The overall goal of the action plan is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation,” it said.
In 1988, I won the Michener-Deacon award to study biotechnology research at the University of Guelph - University of Waterloo Biotechnology Centre. It was a new science at the time and governments were not sure how it ought to be regulated in the area of plant breeding.
I felt it should be regulated just the same as all plant-breeding technologies of the time, including mass mutations using radiation and chemicals. I felt mass mutation, where you could never know what would emerge from scrambled genes, was riskier than precisely moving a single, known gene from one species to another, placing it precisely where you wanted it located.
But big companies, such as Monsanto, saw the opportunity to preserve the technology for themselves if it could be regulated much as pesticides were. It, after all, had expertise in patents, pesticide trials and the long nine yards of regulatory approvals that are far too costly for plant breeders of the time, who often were graduate students working under university professors.
Imagine the difference had we taken the light-handed approach. There would have been dozens of independent researchers exploring hundreds of ideas for improving varieties for the benefit of farmers and society without regard to corporate profits.
Ah, yes; what might have been.
