Imagine the backlash the U.S. Food and Drug Administration would get if it dragged its regulatory heels on approving the process of editing the human genome to cure colon cancer by insisting that edits be approved separately for each race, nationality and other arbitrary group of people. Ridiculous!
But that’s exactly the regulatory approach the agency is considering for gene editing in livestock – separate approval processes for Holsteins, Herefords and Jerseys or for Durocs, Berkshires and Yorkshires.
That regulatory path would result in a lengthy and expensive approval process and functionally would make gene edited animals and their offspring living animal drugs – and every farm raising such animals a drug-manufacturing facility subject to FDA inspection. And approvals would be need regardless of whether any edited gene is “familiar,” meaning it corresponds to a genotype found in the subject animal or a sexually compatible species, or whether a change could be achieved through conventional breeding, though at the expense of time – usually decades – and money.Additionally, FDA would even regulate edits that simply delete a gene.
It’s an approach that would stifle a technology that most certainly will improve the health of animals and people and ensure the safety of our food supply. And that’s why the pork industry has been strongly urging FDA to take a different tack.
The FDA’s proposed regulatory framework is the result of a decades-old administrative decision related to older transgenic biotechnology, where a foreign gene is inserted into an animal’s genome. Gene editing is making simple changes or deletions within an animal’s native genome.
FDA also has indicated that even if it determined that an edit is “safe” in one lineage of a breed of pigs, for example, the edit’s use in another line even within the same breed would need to go through a separate approval process. So, an edit to a gene in Line A of a Poland China could not be used in Line B of the same breed without FDA’s okay.
Under the agency’s proposed plan for regulating gene editing in livestock there are only three possible outcomes: drastic loss of genetic diversity as producers move toward the few approved lines of animals; hundreds or thousands of applications on edits for each livestock breed, line or even herd or flock and the attendant costly and lengthy approval processes; or most U.S. producers forgoing the technology while their competitors around the world reap its benefits.
None is acceptable.
Proponents of gene editing have pointed the Trump administration to the U.S. Department of Agriculture, which is on the right track in regulating the technology, adopting a risk-based approach to reviewing potential genetic changes in plants. USDA easily could adapt that approach for livestock and regulate gene edited animals under the Animal Health Protection Act, they say.
The pork industry supports giving USDA regulatory authority over gene editing in livestock.
But if FDA insists on having oversight, says the pork industry, it should follow the July 2015 presidential memorandum that directed agencies to issue regulations on biotechnologies that not only increase public confidence in such tools but that don’t erect barriers to future innovations or harm competitiveness.
Gene editing has the potential to be game changing for livestock producers. Diseases that have plagued cattle ranchers, hog farmers and other livestock and poultry producers for decades, such as Bovine Respiratory Disease Complex and Porcine Reproductive and Respiratory Syndrome – the most economically significant disease to affect U.S. swine production – suddenly would be gone. Millions of dollars would be saved, animal mortality would decrease and animal health would improve; antibiotic use would drop and production would increase – all to the benefit of consumers.
Do we really want federal red tape to strangle such technology and the promise it holds in its infancy?
Jim Heimerl is a pork producer from Johnstown, Ohio, and current president of the National Pork Producers Council.