Biotech plant developers are pleased with a proposal from USDA's Animal and Plant Health Inspection Service to create five new regulatory exemptions for genetically modified plants
The industry has expressed concern that the U.S. has been falling behind internationally as other countries move toward adopting regulations more favorable to gene-edited crops.
“It's certainly science-based, and I think it's only going to serve to help smaller companies like ours, especially ones working in specialty crops,” Dan Jenkins, vice president of regulatory and government affairs at Pairwise, told Agri-Pulse. The company, which uses CRISPR and gene editing to develop new fruit and vegetable varieties, is also currently in a partnership with Bayer to develop short-stature corn.
“They've broadened things out and created a good scientific record for having those exemptions apply to things that may have more than one edit, and may have more complicated genomes,” Jenkins added. “So that's very positive.”
In a statement Tuesday, Jenkins said “We believe this science-based proposal can help smaller companies working in specialty crops work toward achieving nutrition and sustainability goals.”
One of the five proposed exemptions would be for “plants with up to four modifications made simultaneously or sequentially, provided that each modification individually qualifies for exemption and is at a different genetic locus.”
USDA regulations finalized in 2020 allow “some gene-edited products to be exempt, a status that can be confirmed,” Jenkins and others said in a paper in Nature Plants this year. However, the exemption “is only for a very narrow subset (for example, single edit in a diploid or haplotype), causing most gene-edited plants to go through the same Regulatory Status Review process as traditional transgenic crops.”
Going from a single edit to four is an improvement, Jenkins said, adding, “I really believe that USDA will continue to make adjustments for broadening what could be exempt as they build a record.”
The current proposal, for example, says “they have lots of scientific evidence” to support up to seven edits, he said.
The proposal cites “examples in …crops such as banana, forest trees, crops with complex genomes such as strawberry and sugarcane” as well as potatoes and apples, and discusses selection for multiple genes “in soybean, coffee, tobacco, tomato, potato, corn and rice where four to seven traits are pyramided by conventional breeding methods.”
“The good news is that an instrument was built into part 340 that says, if we need to make new rules to make things better, that's available.”
It will be up to the plant breeding community “to create a record to help support further broadening” of exemptions, Jenkins said. “The burden is on us to share that and show that to USDA.”
The Biotechnology Innovation Organization also welcomed the proposal, with Beth Ellikidis, vice president for agriculture and environment, calling it a “science-based and risk-proportionate action.”
“We thank the agency for its efforts to decrease the backlog of plants in the regulatory docket and allow innovations to reach farmers and consumers,” Ellikidis said in a news release. “Opinion research conducted by BIO shows that the public supports updating regulatory processes to allow agricultural biotechnology companies to commercialize innovative products more quickly.”
Beth Ellikidis, BIOIn an interview, Leah Buchman, regulatory manager at BIO for ag and environment, said it’s “exciting for us to see that there is progress being made internally at [APHIS Biotechnology Regulatory Services] because … pipelines are long and R&D takes a long time, and as you know, companies are able to get things moving much faster than the government can.”
Buchman took note not just of the proposal, which supersedes an earlier proposal for three new exemptions, but of APHIS’ announcement last week that it had determined 12 genetically modified plants are not subject to regulation under 7 CFR Part 340.
Among them are a Bayer soybean resistant to glufosinate, dicamba, 2,4-D, and mesotrione as well as pennycress, an oilseed intended as a biofuel feedstock.
Pairwise also had a plant among the dozen given the all-clear: a form of brown mustard that has “altered pungency to improve flavor and altered outgrowth/texture to reduce appendage development on leaves and stems.”
Jenkins told an audience at the American Agricultural Law Association this month about the gene-altered mustard: “We made them not taste terrible.”
USDA's latest proposal isn't easy to understand. Jenkins said it was “pretty complicated in parts,” and Buchman called the proposal “incredibly complex and dense.”
“We've been asked for plain language versions and we don't have that to give right now,” she said.
Nevertheless, she said at this point, BIO does not anticipate seeking an extension of the Dec. 15 comment deadline.
“That seems to be the feeling throughout industry right now,” she said. “We feel that we can do a good job reading through these exemptions and spend enough time doing a literature review to make sure that we provide expeditious and clear comments.”
The BRS proposal “puts us in a better spot” internally, Jenkins said.
Regulatory systems in Canada and Latin America are the most efficient at this point, and in the European Union, regulators are considering allowing up to 20 edits, he said.
A big difference between the U.S. and other countries is the Balkanized U.S. regulatory system.
While EPA and FDA share regulatory authority for genetically modified crops with USDA, other countries oversee biotechnology with a single agency.
At the BRS annual stakeholders meeting last week, agency officials said if implemented, the new rule would reduce workload by about 20%, though the scope of the new rule can change between the proposal and the final.
Officials also said they had heard and digested comments in response to a December 2022 solicitation for feedback, in which “an overriding theme was the [call for] risk-proportionate regulation,” said Alan Pearson, an assistant deputy administrator for BRS.
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“Although there were differences of opinion among the commenters on what that would look like, most commenters asked that the agencies update their regulatory frameworks to account for genome editing and minimize the regulation of genome-edited products, and to streamline regulations and regulatory processes and reduce regulatory burdens and duplicative regulation,” Pearson said.
According to APHIS, the five proposed exemptions include:
- Plants that have any combination of loss-of-function modifications (modifications that reduce or eliminate a gene’s function) in one to all alleles of a single genetic locus in diploid and autopolyploid plants, or in one or both copies of a single genetic locus on up to four pairs of homoeologous chromosomes in allopolyploid plants.
- Diploid or autopolyploid plants with a single contiguous deletion of any size on one or more chromosomes.
- Autopolyploid plants containing any modification described in existing exemptions that previously applied only to diploid plants.
- Plants with up to four modifications made simultaneously or sequentially, provided that each modification individually qualifies for exemption and is at a different genetic locus.
- Plants that have previously completed a voluntary review confirming exempt status and that have subsequently been produced, grown, and observed consistent with conventional breeding methods appropriate for the plant species, could be successively modified in accordance with the exemptions.
The new proposal could have an impact on a lawsuit challenging APHIS’ 2020 rule. The Center for Food Safety, National Family Farm Coalition and four other groups sued APHIS over the rule, and said the government’s new proposal “underscores the urgent need for this court” to vacate the rule.
The case has been briefed and argued in U.S. District Court for the Northern District of California. USDA informed the court of its latest proposal in a filing on Nov. 14.
In response to the USDA filing, the plaintiffs said, “USDA’s latest proposed implementation of its new scheme would more than double the exemptions included in the [2020] Revised GE Rule, further reducing the little oversight USDA reserved for itself previously.”
“USDA’s filing reveals that, as plaintiffs predicted, the agency has no intention of ever completing its statutory duties under the National Environmental Policy Act and the Endangered Species Act,” the plaintiffs said.
“Already, in just a few short years of operation, the Revised GE Rule’s existing exemptions have exempted at least 64 new GE plants from any review whatsoever,” the plaintiffs said. “At least ten of those have been engineered with herbicide resistance — leading to increased harm from spraying and increased herbicide-resistant weeds — to be commercialized without any analysis or oversight.”
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