The move is “in response to advances in genetic engineering,” the USDA said in a statement.
The changes are detailed in a proposed new rule that would revise the agency’s current method for regulating genetically modified plants. The USDA is currently accepting comments on the proposal.
As of Monday, none had been submitted, and the public response from both industry groups and scientists so far has been fairly mute as the groups digest the complex proposed new regulations.
Officials at the American Seed Trade Association — which represents companies that produce and distribute seeds and breed plants — said they had not read the rule in detail and needed to consult members before expressing support or opposition to the proposed rule.
The Center for Science in the Public Interest and the Biotechnology Innovation Center had similar responses.
“This is a very dense area of the law,” said Thomas Brugato, an attorney with the law group Covington & Burlington LLP, who specializes in environmental law.
What is clear is that under the new rule, far fewer genetically engineered plants would need federal approval — or notification — to be commercially produced.
This could be a win for developers, especially small to midsize companies that cannot currently afford to delve into genetic engineering because of the high cost of applying for permits.
“Our hope is that this will ease that burden considerably,” said Bernice Slutsky, the senior vice president for innovation at the American Seed Council.
But not everyone views that as a positive step.
“Just because none of these plants was harmful in the past doesn’t mean they could never be,” said Greg Jaffe, the Center for Science in the Public Interest’s biotechnology project director.
Besides the potential safety concerns, Jaffe fears deregulation will make it harder for the public to know if and how the plants they consume have been genetically modified.
“One of the things these regulations did besides ensuring safety was ensuring transparency,” he said. “If they don’t have to go through a regulatory process anymore, people can add, edit or pull out genes, and nobody will know.”
The genetically engineered plants that will be excluded from federal regulation are mainly plants with a genetic modification that a breeder could have achieved through “traditional” breeding practices.
Developers will be allowed to “self-determine” if their genetically modified plant fits this category.
Breeders for many years have altered plants’ DNA to produce higher yields, require less water, or resist certain diseases or parasites through selective breeding. That process takes years, but in many cases produces similar results to current gene editing, Slutsky said.
“In some cases, the actual genetic change was the same,” Slutsky said. “It is a very precise way to do what breeders have always done.”
And, according to the USDA, that kind of genetic engineering has consistently been shown to be safe for more than 30 years.
“Regulation should take into account familiarity,” the agency said. “By focusing regulatory resources and risk analyses on unfamiliar products, [the USDA] will be able to avoid conducting repetitive analyses, utilize its staff time more efficiently and provide better stewardship of taxpayer dollars.”
The USDA’s current GMO regulations were created in the 1980s as a way for the agency to regulate all genetically engineered plants.
The rules were crafted based on the most current science at the time. Genetic engineering was just taking off, and the only way scientists could modify a plant’s DNA was to add genes from a different species.
There were only a couple ways to accomplish that.
Often, scientists would use something called an agrobacteria, which is a kind of soil bacteria that will naturally transfer a portion of its DNA into plant cells. Scientists made use of the agrobacteria’s natural infection process by inserting the gene they wanted transferred into an agrobacteria, and then allow that bacteria to infect the plant. When it did, the plant was essentially being infected with the new gene — forever altering its DNA.
When it came time to develop a method to regulate this process, the USDA decided that the simplest approach was to regulate the use of the agrobacteria. The agency already regulated “plant pests,” which agrobateria technically were.
This allowed the agency to regulate all genetically modified plants by default — until recently. Scientists now have several other methods to alter a species’ DNA that don’t require using agrobacteria.
The law is becoming more and more obsolete, government officials said.
“Given these developments,” the USDA said, “it has become necessary, in our view, to update our regulations accordingly.”
This is not the first time the USDA has attempted to revise its GMO rules. Most recently, a 2017 Obama administration proposal that would presumptively regulate most genetically modified organisms was tossed out by the Trump administration.
Trump officials withdrew that proposal after industry groups claimed it would create too many regulatory burdens.
