USDA reveals plans to regulate GM plants based on traits, not breeding method

Credit: Shutterstock

USDA’s Sid Abel and Doug McKalip just briefed me on the new regulatory framework that is shaping up for the oversight of plants modified by what they are now calling “plant breeding innovations.” These include the much-touted CRISPR/Cas-based gene editing, as well as other new approaches to the modification of plants’ genetic material.

I could barely believe what I was hearing. So here goes…..

To begin with, as announced in late March by USDA Secretary Perdue, the agency does not and will not regulate plants that could have been developed using what are now considered “traditional” methods of genetic modification. I drilled down a bit, since I know what kinds of things happen when plants are subjected to such “traditional” methods of genetic modification as radiation and chemical mutagenesis. These include breaks in the DNA, the repairs of which are often a bit untidy, resulting in small insertions and deletions (elided into “indels”), in addition to single base changes. And yes, they intend to exclude such minor changes from regulation.

It’s worth mentioning here that such DNA sequence changes occur all the time in all organisms – they’re the stuff of evolution. 20thcentury scientists figured out how to increase the frequency of such genetic changes using chemical and radiation mutagenesis. This was a very widely used strategy in 20th century plant breeding. So widely used that half or more of the food crops grown today (including organic crops) have such a mutagenesis step in their pedigrees.  Mutagenized plants and seeds are grown in untold millions and examined for useful genetic changes, aka mutations. These techniques for genetic modification were not, and are not, regulated.

It is also perhaps worth mentioning that artificially induced mutations are indistinguishable from naturally occurring mutations at the DNA sequence level. They are also indistinguishable from the genetic changes produced by the newer methods, such as CRISPR/Cas-based gene editing. New plant varieties produced using chemical and radiation mutagenesis have never been regulated. Nor have they produced either human and animal health or agricultural disasters. So is quite sensible not to regulate new plant varieties with the same kinds of mutations produced by the newer, more specific techniques.

The indistinguishability of genetic changes made by nature, 20th century mutagenesis and 21st century gene editing highlights the absurdity of regulating genetic modification based on the process used, as the Court of Justice of the European Union (CJEU) ruled in July of 2018. Specifically, the CJEU ruled that gene-edited organisms must be regulated, assessed for their health and environmental impacts, and labeled because they constitute genetically modified organisms (GMOs) under the original directive.

Related article:  China approves imports of two GMO soy varieties, green lighting production in Argentina

But I digress. There’s more good news….

USDA plans to confine its regulatory oversight to organisms that might actually damage agriculture, as specified under the Plant Protection Act (PPA). If the organism is neither a weed nor a plant pest, it does not come under the jurisdiction of the PPA. And it won’t be subject to regulation. But even if it is a plant pest or weed, the proposal is to issue permits that will allow developers to proceed to commercialization, even as the USDA regulators determine whether the modification might increase the organism’s potential to harm agriculture.

This is a really important change. The decision will be based on the actual properties of the organism and the small number of traits that could be problematic, not on the method by which the trait was introduced. And new instances (previously called “events”) of organism/trait combinations that have already passed through the regulatory process will not have to do it again.

Yes, there are some fine points yet to be worked out. When the proposed regulations are published for comment, probably early next year, there will be a good bit of controversy. And of course this puts US policy at odds with the biotechnology regulatory policies of a number of other countries.

But the fact of the matter is that we are now able to modify plants with exquisite precision to make use of the enormous fund of molecular and physiological knowledge about them accumulated over the past century. Taking apart the regulatory thicket will make it possible for scientists in all kinds of institutions and not just big biotech companies to use the most advanced molecular techniques to solve the many local agricultural problems that are becoming ever more acute as the climate warms and agriculture intensifies.

Nina Fedoroff is Emeritus Professor of Biology at Penn State University. 

This article was originally published at AgriPulse as Opinion: Trait-based regulation of GM plants is on the horizon – at last! and has been republished here with permission.

Outbreak Daily Digest
Biotech Facts & Fallacies
Talking Biotech
Genetics Unzipped
can you boost your immune system to prevent coronavirus spread x

Video: How to boost your immune system to guard against COVID and other illnesses

Scientists have recently developed ways to measure your immune age. Fortunately, it turns out your immune age can go down ...
mag insects image superjumbo v

Disaster interrupted: Which farming system better preserves insect populations: Organic or conventional?

A three-year run of fragmentary Armageddon-like studies had primed the journalism pumps and settled the media framing about the future ...
dead bee desolate city

Are we facing an ‘Insect Apocalypse’ caused by ‘intensive, industrial’ farming and agricultural chemicals? The media say yes; Science says ‘no’

The media call it the “Insect Apocalypse”. In the past three years, the phrase has become an accepted truth of ...
globalmethanebudget globalcarbonproject cropped x

Infographic: Cows cause climate change? Agriculture scientist says ‘belching bovines’ get too much blame

A recent interview by Caroline Stocks, a UK journalist who writes about food, agriculture and the environment, of air quality ...
organic hillside sweet corn x

Organic v conventional using GMOs: Which is the more sustainable farming?

Many consumers spend more for organic food to avoid genetically modified products in part because they believe that “industrial agriculture” ...
benjamin franklin x

Are most GMO safety studies funded by industry?

The assertion that biotech companies do the research and the government just signs off on it is false ...
gmo corn field x

Do GMO Bt (insect-resistant) crops pose a threat to human health or the environment?

Bt is a bacterium found organically in the soil. It is extremely effective in repelling or killing target insects but ...

Environmental Working Group: EWG challenges safety of GMOs, food pesticide residues

Known by some as the "Environmental Worrying Group," EWG lobbies for tighter GMO legislation and famously puts out annual "dirty dozen" list of fruits and ...
m hansen

Michael Hansen: Architect of Consumers Union ongoing anti-GMO campaign

Michael K. Hansen (born 1956) is thought by critics to be the prime mover behind the ongoing campaign against agricultural biotechnology at Consumer Reports. He is an ...
News on human & agricultural genetics and biotechnology delivered to your inbox.
Optional. Mail on special occasions.
Send this to a friend