Hogs

The Food and Drug Administration has explained its plans to regulate gene-editing in animals.

Gene editing in livestock holds the potential for enormous benefits for U.S. agriculture. But the technology faces an impractical, lengthy and expensive approval process under Food and Drug Administration regulatory oversight, according to the National Pork Producers Council.

On Tuesday, NPPC began its new Keep America First in Agriculture campaign with a media teleconference to illustrate the importance of the technology to animal agriculture and the need to establish regulatory oversight under USDA instead of FDA.

Gene editing is a precise and targeted technology that introduces a useful genetic variation in food animal breeding programs and is analogous to conventional breeding,  said Alison Van Eenannaam, an animal genomics and biotechnology specialist at the University of California-Davis.

“At the end of the day, gene editing really opens up a new opportunity for breeders to address critical problems such as disease resistance, animal welfare traits like dehorning and resilience like heat tolerance and also product quality traits,” she said.

Basically, it allows for precise, small change to specific genes that can have a huge impact, particularly on disease resistance, said veterinarian Dan Kovich, NPPC director of science and technology.

One of the largest concerns in the pork industry today is the global spread of African swine fever, and the EU and China specifically are making significant investments to create a pig that is resistant to the virus, said Bradley Wolter, president of the Maschhoffs, a family-run company with operations in nine states.

The concern is the proposed FDA regulations would preclude the use of gene editing in the U.S. and put the industry’s competitive position at risk, he said.

The same is true with porcine reproductive and respiratory syndrome — known as PRRS — a viral disease that causes reproductive impairment or failure and respiratory disease.

“The potential trade barriers associated with our regulatory position would be devastating, in our opinion, to the U.S. pork industry,” he said.

In a laboratory setting, it has already produced pigs resistant to PRRS, which costs the U.S. hog industry $1 billion annually.

“That will really, really revolutionize how we control that particular disease,” he said.

Gene editing also offers promise in combating other diseases, such as African swine fever and foot and mouth disease, he said.

African swine fever has swept through the industries in China, Vietnam, Hong Kong, Taiwan, North Korea, Cambodia and Mongolia, forcing millions of hogs to be culled. 

But despite all the promises of gene editing  technology, the proposed regulatory framework under FDA leaves U.S. agriculture at a disadvantage to other countries, said Andrew Bailey, NPPC lead counsel for science and technology.

FDA is seeking to regulate the animal altered genome as a drug instead of regulating the technology that alters the genome, regardless of the gene-editing technology or whether the alterations are heritable, he said.

It would consider each specific alteration as a separate new animal drug requiring approval, and it would retain authority over the initial altered animal and its progeny in perpetuity, he said.

“This approach creates, as you might imagine, a host of problems related to on-farm and in-plant authority as well as enormous trade barriers,” he said.

No other country has approached regulation of gene editing technologies the same way as FDA is proposing, he said.

Argentina, Brazil and Canada have already adopted risk-based regulations that are far less onerous. Many other countries are looking to adopt the technology recognizing they need to update their regulations to accommodate it, he said.

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