USDA Approves Deregulation of GMOs with Up to 12 Genetic Modifications

The USDA’s Animal and Plant Health Inspection Service (APHIS) has now deregulated certain GMO crops, allowing plants with up to 12 genetic modifications to bypass regulatory oversight if these modifications could theoretically be achieved through conventional breeding methods. APHIS published the final notice on Wednesday, noting that it received 6,500 comments regarding the proposal. The final regulation includes “two additional modifications” that “provide additional flexibilities in how developers can use biotechnology to create modified plants that could have been achieved through conventional breeding; and increase the number of modifications a plant can contain, from one modification to as many as twelve modifications, and qualify for exemption from regulation.”

The HighWire reported on this proposal last November and spoke with Dr. Michael Antoniou, a professor of molecular genetics at King’s College in London. Dr. Antoniou warned about the potential results of blanket deregulation of GMOs, in which they are treated as any seed that can be developed through natural breeding.

“The market will be flooded with untested and unlabeled gene-edited food products with unknown short-term, let alone long-term, health and environmental consequences,” Antoniou said. “This is simply a horrifying prospect.”

The final notice on the Federal Register states, “The comments were diverse and from interest groups, industry representatives, industry trade organizations, private individuals, scientists, plant breeders, and crop specialists.” The original proposal, open for public comment, sought exemptions for GMOs with up to four modifications. APHIS noted that many comments requested an increase in the number of modifications allowed under the exemption. Based on this feedback and literature references indicating that 12 simultaneous or sequential modifications are possible through conventional breeding methods, the number of allowable modifications was raised from four to twelve.

Bayer Crop Science and other biotechnology companies submitted comments calling for an increase in the number of modifications, which APHIS ultimately fulfilled. Michael Watson, the APHIS administrator, responded to comments in the federal register. One comment pointed out the large number of lawsuits related to glyphosate and the wide usage of glyphosate-resistant GMOs that increased the chemical usage. Watson responded by saying that according to the CEO of Bayer, 90% of the litigation comes from the residential lawn and garden market. He added that residential consumers of glyphosate don’t use the product on glyphosate-resistant seeds.

Several comments raised concerns about the potential safety risks of untested seeds. In response, APHIS stated that the modifications in these seeds could be achieved through conventional breeding methods, and therefore, they pose no greater risk than conventionally bred, non-GMO seeds.

Dr. Antoniou disagreed with this assessment when he spoke with The HighWire last year, saying, “Even if a gene-edited plant could theoretically be obtained through natural breeding (and by the way, there is no evidence that any GM gene-edited plant could have been produced with natural breeding; I believe that if two such plants produced using these two different techniques were put forward, they would be very different at the genetic and molecular levels and could have very different biological effects), the two PROCESSES (gene editing and natural breeding) bear no resemblance to each other with the spectrum of unintended DNA mutations differing markedly between the two.”

Other commenters expressed concern about cross-pollination, which APHIS calls “commingling.” APHIS said the modifications in this new set of regulations would have fallen outside of the scope of the previous regulations. The agency said exempted gene edited crops would not qualify for organic designation, and the farm would not lose organic designation if commingling does occur.

APHIS said commingling is possible, but the risk is low. APHIS also said 1-3% of non-GE farmers report having commodities rejected for having GE material and the economic losses amounted to 0.7% in 2010. In that year, the organic farming industry made $29 billion which would mean there was an economic loss of $203 million for the 14,540 organic farms in the United States that year. The organic farming industry has increased sales to more than $67 billion in 2023, which would reflect a $469 million dollar financial loss from wind drift of genetically engineered seeds.

APHIS responded to concerns about unintended modification occurring in the process by saying background modifications also happen in conventional breeding. APHIS believes that genetically engineered seeds are similar to conventionally bred seeds and thus they should be regulated similarly.

Dr. Antoniou also disagrees with this response by APHIS. He said, “Reviews of the literature confirmthat gene editing can produce changes that conventional breeding could not achieve, or could only achieve with difficulty, as gene editing opens areas of the genome to DNA damage (mutations) that are protected from mutations in conventional breeding and mutagenesis breeding using chemicals or radiation.”

In the original proposal, Bayer stated, “the additionally proposed exemptions that are intended to cover genetic modifications that “could otherwise be created by conventional breeding”, do not cover types of modifications that are most commonly utilized to develop new traits. Instead, they cover modifications that have already been created by conventional breeding and not those that could be created by conventional breeding but for which no scientific publication exists.”

This comment appears to confirm that there is no “scientific publication” that confirms these modifications would be achievable through conventional means. APHIS also updated the regulations following the comment period to allow “gain of function” modifications when it “results from natural DNA repair in the absence of a repair template.”

Lastly, APHIS removed the requirement for developers to “verify a plant’s exempt status before making sequential modifications and outlined conditions to ensure that simultaneous or sequential modifications were made in plants that had been produced, grown, and observed, consistent with conventional breeding practices.” Since this is no longer a requirement, APHIS will only “accept voluntary requests” to clarify that the modifications qualify for exempt status.

APHIS explained that this change is because hypothetical modifications may not be viable or produce the intended results. Former Director of National Intelligence James Clapper warned in 2016 that the deregulation of gene editing and CRISPR technology is a national security risk as it relates to genetically engineering mosquitoes, human embryos, or the creation of bioweapons.