Regulation of Gene-Edited Animals
Gene editing can improve animal health, reduce antibiotic use and help produce safe food if it is not over regulated.
NPPC supports the proposal to move regulatory oversight of gene-edited livestock from the Food and Drug Administration (FDA) to the United States Department of Agriculture (USDA). The USDA already regulates gene editing in plants and can ensure proper, risk-based regulatory review under the Animal Health Protection Act and the inspection laws for meat, poultry, and eggs.
The United States Department of Agriculture (USDA) has a proven track record in risk-based, pro-science regulation of biotechnology. USDA published an advance notice of proposed rulemaking (ANPR) on the regulation of gene-editing technology in livestock species.
The proposal calls for USDA to regulate gene-editing in livestock under its authority through the Animal Health Protection Act and the Federal Meat Inspection, Poultry Products Inspection, and Egg Products Inspection Acts. The Food and Drug Administration (FDA) may appropriately regulate some products of gene-edited animals as human or animal drugs or devices, but not the livestock animals themselves.
USDA and FDA recently signed a related memorandum of understanding (MOU), recognizing each agency’s role in regulating new technology in livestock. The ANPR begins the public rulemaking process involving agricultural producers, academics, the biotechnology industry, and consumers.
Under a previous FDA proposal, the agency would regulate gene editing in livestock through non-binding guidance issued under its animal drug authority. That regulatory path would have resulted in lengthy and expensive approval processes by making any gene-edited animal a living animal drug. Therefore, establishing farms as drug manufacturing facilities.
That proposal would not allow for a risk-based approach that considers the familiarity or complexity of the genetic changes and whether those changes could be achieved through conventional breeding techniques. The FDA also indicated that only the descendants of the animals studied, not the edit for the entire species, would be considered for approvals. In other words, even if FDA had determined that an edit is “safe” in one lineage of a breed or strain, its use in any other strain (even within the same breed) would go through a separate approval process.
Gene editing is making simple changes or deletions within a pig’s native genome. Gene editing holds the significant promise to improve the health and well-being of pigs, further strengthen food safety, lessen the need to use antibiotics, and reduce pork operations’ environmental impact.
USDA issued an ANPR on the regulation of gene editing
in livestock and signed a related memorandum of understanding with FDA on the roles each agency plays in gene editing of livestock.
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