More than 20 House Energy & Commerce Committee members sent a letter to acting FDA Commissioner Ned Sharpless on [July 26] urging the agency to “develop a more appropriate, workable approach” to regulating animal biotech. The bipartisan group said the FDA’s regulatory framework threatens farmers and consumers’ access to such advances, while driving research “into the hands of foreign competitors.”
…. Under the current system, the agency regulates the DNA of intentionally altered animals as an “animal drug,” even if the genetic variations could have occurred naturally. The regulatory process can drag on for years, and it leaves the door open for other countries to impose trade barriers on U.S. livestock products.
“This burden is deterring many academics and developers from conducting research and will likely consolidate the industry to only the largest companies,” the lawmakers wrote in the letter. They cited potential benefits of animal gene-editing like limiting the spread of African swine fever or allowing livestock producers to curb their use of animal antibiotics.
The latest call for changing the GE rules comes amid a broader regulatory turf war: Farm groups have pushed for USDA to play a bigger role in regulating the burgeoning biotechnology ….
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