US politicians concerned over ‘contradictory’ biotech regulatory efforts
Nearly 80 members of the House of Representatives have written to the heads of three government departments to voice concerns over regulatory proposals in the biotechnology and gene-editing fields.
Dated October 17, the letter is addressed to Sonny Perdue, head of the Department of Agriculture (USDA), Food and Drug Administration (FDA) commissioner Scott Gottlieb, and Scott Pruitt, chief of the Environmental Protection Agency.
They said that recent regulatory proposals are contradictory and sent inconsistent signals to the US’s trading partners.
The letter comes as the agencies continue to engage in the Interagency Task Force on Agriculture and Rural Prosperity, which President Donald Trump set up to review regulation affecting agriculture and rural communities.
As these efforts and other changes are explored, several recent efforts warrant attention, according to the representatives.
The first is a draft revision to the Part 340 biotech regulations published by the USDA’s Animal and Plant Health Inspection Service.
According to the service’s website, these regulations, which cover the importation, interstate movement and environmental release of certain genetically engineered organisms, need to be updated in response to “advances in genetic engineering and our accumulated experience in implementing the current regulations, as well as reduce the burden on regulated entities”.
It is the first “comprehensive” revision of the regulations since they were created in 1987.
In addition, the letter said, the FDA has proposed expanding the scope of industry guidance #187 to regulate as a new animal drug “any animal intentionally altered using gene-editing techniques”.
The letter’s signatories said they are concerned that the two proposals offer “deeply conflicting” regulatory approaches.
Given that the proposals are sending “inconsistent signals” to trading partners, “we are concerned that if the Administration does not quickly develop a uniform position on biotechnology in agriculture, including gene editing, we will see an unworkable patchwork of international regulations emerge that will effectively further suppress American innovation”, the politicians wrote.
They then urged the government officials to coordinate with each other and stakeholders to improve the proposals in ways that are “consistent and foster innovation”.
The letter’s signatories include Bob Goodlatte, who has previously been active in IP legislative attempts, as well as Ron Kind and Mia Love.
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