The day before the presidential inauguration, FDA published two notices in the Federal Register related to the regulation of intentionally altered genomic DNA in animals and genome editing in new plant varieties used in food.
Also on Jan. 19, the US Department of Agriculture published in the Federal Register a proposed rule about the importation, interstate movement and environmental release of certain genetically engineered organisms.
FDA seeks guidance on GE plants
In FDA’s request for comments on the use of genome editing to produce new plants for food, the agency asks how the safety of genome edited plants is different from or the same as those from conventional plant development, such as hybridization or chemical or radiation-induced mutagenesis and non-targeted genetic modification.
To ease the potential regulatory burden placed on innovators using genome editing, the agency also asks if there are categories of genome edited plants that are similar enough to traditionally bred plants that they could skip using voluntary premarket consultation services.
On the flip side, it also asks if there are plant categories for which genome editing would pose greater safety risks than those from traditional breeding techniques.
And, finally, FDA asks if there are steps that it could take to help small firm’s using genome editing to engage with the agency about questions they may have related to food safety or regulatory status.
Answers or comments on the points should be submitted to FDA by March 20, according to the notice.
FDA expands guidance on GE animals.
FDA also published the same day a revised draft guidance that expands the scope of existing guidance on genetically engineered animals to include animals intentionally altered through genome editing techniques.
In a Q&A published on FDA’s website, the agency explains the update is necessary to account for the difference between older genetic engineering techniques and newer genome editing options.
“Genome editing is a much more precise method of making changes to the genome of a plant, animal or other living organism than methods used previously to make such changes,” FDA explains.“It also allows for the international addition, substitution or deletion of specific nucleotides … in an organism’s genome. Genetic engineering generally allowed for in the introduction of new DNA … into an organism to alter that organism’s genome, but generally without control of the location in the genome in which the insertion of that rDNA construct would occur.”
In addition to expanding the scope of the guidance, the revision clarifies FDA’s requirements and recommendations for the development of the altered animals and their products, and explains how related FDC Act provisions apply to the animals.
USDA revisits importation and release rules
Finally, USDA also proposed a rule Jan. 19 on the importation, interstate movement and environmental release of GE organisms that would, if finalized, reduce the burden on producers of organisms that do not pose plant, pest or noxious weed risks.
The agency explains that advances in genetic engineering since the original rule was promulgated have created new challenges that have prompted the revision, even though the “current regulations have been effective in ensuring the safe importation, interstate movement and environmental release of GE organisms developed using genetic engineering during the past 29 years.”
It adds, the proposed changes also are needed because based on its “nearly three decades of experience in evaluating GE organisms for plant pest risk,” most GE techniques do not result in an organism that poses a plant pest risk.
A broad national strategy
All three notices are related to a national strategy for modernizing the regulatory system of biotechnology products that was first established last September. In that strategy, the agencies promised to work together with the Executive Office of the President to outline “a vision for ensuring that the federal regulatory system is equipped and assesses efficiently the risks, if any, associated with the future products of biotechnology,” according to FDA.
At the same time, the modernization effort strives to “protect health and the environment while preventing unnecessary barriers to future innovation and competitiveness,” according to FDA’s website.
The strategy, as outlined on FDA’s website, also includes a mandate that EPA, USDA and FDA publish annually a report on the specific steps they are taking to implement the strategy.
The future of the project, however, is unclear given the change in the presidential administration. President Trump has promised to undo much of what Obama’s administration pushed forward. Even those projects that are not axed by the new administration might not enjoy the same level of support as the new administration likely has different priorities that likely will impact the level of pressure if places on some projects.