CRISPR had quite a 2020. Not only did the cutting edge genetic engineering technique give us hope for better and faster COVID-19 tests and help advance new treatments for diseases like cancer, but its creators also received the world’s most prestigious award in science when they received the Nobel prize for chemistry for their pioneering work.
CRISPR’s also been marching forward in the food world. Pairwise, for example, made regulatory headway this year in advancing gene-edited produce in the form of a mustard green that actually tastes good and has a strong nutrition profile.
However, while we’ve seen some limited momentum when it comes to animals and CRISPR, such as making chickens more resistant to avian leukosis virus, regulatory approval for gene-edited animals has been slower ever since the FDA declared that molecularly manipulated animals needed to be regulated like drugs.
But that may soon change. Last week, the U.S. Department of Agriculture (USDA) pushed out a proposed rule change suggesting that they take over the regulatory oversight of gene-edited animals from the FDA.
According to the proposed rule change, regulatory oversight of gene-edited animals for human consumption would be transitioned almost entirely to the USDA. From the release:
USDA would in most instances serve as a single point of entry for amenable species modified or developed using genetic engineering that are intended for agricultural purposes and would provide coordinated end-to-end regulatory oversight from pre-market animal pest and disease risk and human food safety reviews through post-market human food safety reviews for amenable species modified or developed using genetic engineering intended for use as human food.
First flagged by Wired, the news is an important potential development as the USDA – which has had oversight of CRISPR regulation for plant-based food – has taken a fairly laissez-faire approach relative to other US agencies. In 2018, the agency declared that CRISPR-edited crops would not require additional regulation.
With the proposed rule change, the USDA now wants to take an accelerated approach when it comes to gene-edited animals, a change that would also expand the scope to include oversight on whether the bio-engineered animals are safe for human consumption.
According to the proposed rule change, if the genetically modified animal was intended for human food consumption, the animal would undergo a risk-based and science-based review focused on food safety (in addition to animal health).
During this review, the proposed rules state that if the “USDA finds that the modification made using genetic engineering is equivalent to what can be accomplished through conventional breeding practices, the animal would not be subject to further regulation under the contemplated regulatory framework.”
If there were are resulting changes to the molecular structure of the animal outside of what would happen during traditional animal breeding – such as unintended DNA insertions – the agency would then notify the party responsible and a permit would be required to import, sell or release such an animal into a wider population.
The proposed rule change would cover pretty much all the same animal species the USDA currently regulates, from cattle and sheep to fish and poultry. The notice of proposed rule change is currently in the public comment period, which will last through February 26, 2021.
While the U.S. was the early leader in CRISPR-based intellectual property, China’s actually taken the lead when it comes to CRISPR-based agriculture innovation. This move by the U.S.’s primary food and agriculture regulatory agency to relax its oversight could help the country regain momentum as the world’s two largest economies continue to battle it out in this important future food battleground.