U.S. pork producers will fall behind global competitors if the U.S. Food and Drug Administration continues to move forward with plans to regulate livestock gene editing as a drug. That was the message the National Pork Producers Council delivered during a media teleconference Tuesday on the current regulatory oversight of gene-edited livestock on America’s farms.
Gene editing accelerates genetic improvements that could be realized over long periods of time through breeding. It allows for simple changes in a pig’s native genetic structure without introducing genes from another species. Emerging applications include raising pigs resistant to porcine reproductive and respiratory syndrome, a highly contagious swine disease that causes significant animal suffering and costs pork producers worldwide billions of dollars.
“Despite all of the promise of the technology in the U.S., our current proposed, recognized framework for this leaves us at a huge disadvantage to other countries across the world,” says Andrew Bailey, NPPC’s lead counsel for Science and Technology.
Bailey, who practiced regulatory and administrative law with a focus on USDA and FDA food and agriculture issues prior to joining NPPC, highlighted how FDA’s draft guidance for Industry #187 “Regulation of Genetically Engineered Animals” would work if it moves forward.
“FDA is seeking to treat the animal’s altered genome itself as the drug instead of the actual technology that altered the genome on the theory that it’s intended to affect the structure or function of the body of the animal,” Bailey says. “They are proposing to consider each specific genomic alteration as a separate new animal drug requiring approval. The FDA would also restrict any new animal drug approvals in food-producing animals to the individual animals and their progeny.”
The agency’s proposed framework would require companies to seek a separate approval for the same genomic alterations in each new lineage into which it is introduced. The FDA would also consider all animals with the altered genome, and from the same lineage, to contain an animal drug, including those that acquire the alteration through cross breeding. The FDA would then retain the authority over these initially treated animals as well as all progeny in perpetuity.
“This approach creates, as you might imagine, a host of problems related to on-farm management and authorities as well as enormous trade barriers,” Bailey says. “For example, under this interpretation, farms producing GE animals could meet the definition of drug manufacturing facilities.”
Bailey says it is important to point out that no other country has approached regulation of GE technologies the same way as FDA is proposing, and countries such as Argentina, Brazil and Canada have already adopted risk-based GE regulations that are far less onerous than the United States.
In 2012, Argentina implemented the regulatory framework for ag biotech, which has reduced approval times and bureaucracy related to the approval of such products. Under their framework, new products are evaluated on a case-by-case basis, taking into consideration the process only in those instances where the environment, agricultural production or the health of humans or animals could be at risk and then they apply rigorous scientific and technical criteria.
Also, the country has updated their regulations on animal biotech, specifically in 2017 to include new technologies such as gene editing. In addition, Argentina has passed laws to promote the development and production of biotech, by bringing in tax incentives to qualifying research and production products.
“In 2017 they actually inaugurated a new center for animal reproduction biotech, specifically to conduct research related to gene editing,” Bailey says. “So far they have moved forward on several projects including most recently approving field trials with the AquaBounty salmon in Argentina.”
In 2005, Brazil passed a law governing biotech, which established the National Technical Biosafety Commission. To evaluate new breeding technologies, which they regulate on a case-by-case basis, the commission considers the risk level of classification of the modified organisms, information on the manipulated genes or genetic element and whether the product has already been approved in other countries. In October 2018, the commission determined that gene-edited hornless cows are conventional animals and these cows and their products can enter the market.
“In fact, the U.S. company that develops such a cow can now begin commercial production in Brazil and the cow can be marketed in Brazil as being from a conventional animal,” Bailey says.
Canada regulates biotech products as part of their existing regulatory framework for novel products, which focuses on traits expressed rather than on the methods used to introduce those traits. Gene-edited animal products approved for food or feed are treated no differently than their respective conventional animals or animal products under their regulatory process, regardless of the technological processes involved in raising, growing, producing or manufacturing such products.
“Although they do not yet have commercial production for GE animals, the AquaBounty GE salmon has been approved and they are currently constructing commercial facilities. And just in 2018 the Canadian bovine genetics company Semex has said it will partner with a U.S. biotech company to introduce the hornless dairy cows in Canada.”
Beyond these countries, Bailey says many other regions are looking to adopt gene-editing technology, recognizing the need to update the regulations to accommodate it.
“Diseases such as African swine fever are driving extreme interest in GE livestock across Europe and in China,” Bailey says. “In fact at a gene-editing conference in the Netherlands just last week there appeared to be tremendous interest in reforming the EU’s gene-editing regulations with the European Commissioner for Health and Food Safety warning that Europe will be left behind as a quote ‘food museum’ if it does not move forward to modernize its regulation.”