The Agriculture Department has finalized a sweeping overhaul of its approval process for biotech crops that will exempt some gene modifications from regulation and allow developers to decide on their own whether their products qualify.
Biotech companies also won’t be required to notify USDA before commercializing crops the firms believe are exempt from the department’s oversight.
The final rule announced Thursday marks the first major changes to a regulatory process developed in 1987, long before the first genetically engineered seeds would hit the market in the 1990s and decades before gene editing enabled faster crop modifications without the insertion of genetic material from other species.
"We appreciate the USDA and Secretary [Sonny] Perdue for their common-sense approach to encouraging innovation," AFBF President Zippy Duvall said. "At a time when agriculture is facing many economic headwinds, the science-based rule provides the opportunity to solve current and future challenges for agricultural production and food security."
NCFC President Chuck Conner said that "by providing a modern framework, the rule will help spur development of new traits and technologies and ensure a streamlined approval process based in science." And NSP CEO Tim Lust said "USDA's approach is commensurate with the broadly acknowledged low-risk and substantial benefits associated with these breeding innovations."
The final rule from USDA’s Animal and Plant Health Inspection Service says it “provides a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of genetically engineered organisms that are unlikely to pose plant pest risks.”
APHIS said the exemptions would “apply to plants containing single targeted modifications” and declined to require biotech developers to notify APHIS of their determinations.
Many exporters and food companies were strongly critical of the proposed rule in part because notification was not mandatory, but USDA left it as voluntary.
“The confirmation process laid out in the June 2019 proposed rule was voluntary, and switching over to a ‘mandatory’ confirmation and/or notification process in this final rule would run counter to the spirit of regulatory relief underlying our new regulatory framework,” the final rule said.
“The exemptions were formulated to apply to what could otherwise be achieved through conventional plant breeding techniques in any species,” APHIS said. “The plants that are eligible for exemption would have no increased plant pest risk than conventionally bred plants.”
APHIS described the “single modifications” that will qualify for regulatory exemption under the rule:
- The genetic modification is a change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template;
- The genetic modification is a targeted single base pair substitution;
- The genetic modification introduces a gene known to occur in the plant’s gene pool, or makes changes in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool.
The exemptions “are based on measures that are easily defined, are based on familiarity, and thus are meant to be limited to genetic changes that could practically be achieved by conventional breeding methods in any plant,” APHIS said.
APHIS said it will consider exempting plants with “additional modifications, based on what could be achieved through conventional breeding.”
It “anticipates scientific information and/or experience may, over time, allow [it] to list additional modifications that plants can contain and still be exempted from the regulations so that the regulatory system stays up to date and keeps pace with advances in scientific knowledge, evidence, and experience. This may include multiple simultaneous genomic changes.”
Explaining its decision to exempt “single modifications,” APHIS said “it is not possible to define a number of such changes greater than one which could practically be achieved by conventional breeding methods in all plant species. The number of changes that can practically be achieved through conventional breeding methods can vary widely from one species to another.”
Farmers adopting GE crops “may benefit from the rule,” APHIS said. Responding to comments, APHIS said farmers “may benefit by having access to a wider variety of traits as well as a greater number of new GE crop species, affording them a broader selection of crops to suit their particular management objectives.
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“Among the types of innovations expected are crops with greater resistance to disease and insect pests; greater tolerance of stress conditions such as drought, high temperature, low temperature, and salt; and more efficient use of fertilizer.”
Growers of “identity-preserved crops,” such as “organic, other non-GE and other agricultural commodities segregated for specific purity and quality tolerances” could see negative impacts, APHIS said.
Wider adoption of GE crops “may increase the possibility of cross-pollination or commingling,” APHIS said. “As commercial acreage of any given GE crop increases and as a greater variety of crops are modified using genetic engineering, the potential for more instances of unintended presence of a GE organism increases. Costs incurred by growers of organic and other identity-preserved varieties who seek to prevent such unintended presence may increase.”
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