The National Pork Producers Council warns proposed U.S. Food and Drug Administration regulations governing the use of gene editing technology in livestock will render American livestock producers less competitive in the global market.
The National Pork Producers Council fears proposed Food and Drug Administration regulations governing gene editing will result in an impractical, lengthy and expensive approval process and notes the regulation inaccurately classifies livestock as drugs and farms as drug-manufacturing facilities.
Andrew Bailey, the NPPC’s Lead Counsel for Science and Technology, says the proposed U.S. Food and Drug Administration regulation governing the use of gene editing technology in livestock will render American livestock producers less competitive in the global market.
Under this guidance CVM is proposing to consider each specific genomic alteration as a separate new animal drug requiring approval and they would restrict any new animal drug approval in food producing animals to the individual animals and their progeny. The agency would require sponsors to seek a separate approval for the same genomic alteration in each new lineage into which it is introduced.
In the case of heritable genomic alterations CVM would also consider all animals with the altered genome from the same lineage to contain an animal drug, including those that acquired the alteration through cross breeding. They would retain the authority over in the initially treated animals as well as all of the progeny in perpetuity and forever.
This approach creates, as you might imagine, a host of problems related to on farm and in plant authorities as well as enormous trade barriers. For example, under this interpretation, farms producing GE animals could meet the definition of drug manufacturing facilities.
~ Andrew Bailey-National Pork Producers Council
Bailey says it’s important to note that no other country has approached the regulation of genetic editing technology the same way as the Food and Drug Administration is proposing.
Among competitors in the Ag biotech arena, Argentina, Brazil and Canada have already adopted risk based GE regulations that are far less onerous.
