In a move welcomed by farm and biotech groups but met with wariness by food safety and organic advocates, USDA has decided to take another stab at biotech regulations, withdrawing a proposed rule that mostly pleased no one.
The department’s Animal and Plant Health Inspection Service said it “will re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.”
“It’s critical that our regulatory requirements foster public confidence and empower American agriculture while also providing industry with an efficient and transparent review process that doesn’t restrict innovation,” USDA Secretary Sonny Perdue said.
In a Federal Register notice scheduled for publication Tuesday, APHIS noted the wide divergence of opinions it received on its Jan. 19 proposal to amend the “part 340” regulations.
“Some thought that our criteria for designating (genetically engineered) GE organisms as regulated organisms were too expansive, potentially resulting in our regulating a wider range of GE organisms than necessary and thereby increasing, rather than reducing, the regulatory burden for the biotechnology industry,” APHIS noted. “Other commenters, however, thought that certain exemptions and exclusions contained in the proposed rule would effectively narrow the scope of our regulatory authority over GE organisms and increase the risk of the unintended presence of GE crops in organic and other non-GE crops.”
Groups issuing statements in favor of the withdrawal included the Biotechnology Innovation Organization, National Association of Wheat Growers, National Corn Growers Association (NAWG) and the American Seed Trade Association.
BIO said it was happy with the proposal’s “science-based exclusion of some classes of gene editing, and the recognition of the safety of familiar crop-trait combinations with which they have years of experience.” However, the proposal also had “significant flaws that would have rendered the proposedsystem difficult to implement and created greater uncertainty for developers.”
In particular, BIO said in its June comments that it objected to APHIS’s proposal to use the Plant Protection Act (PPA) to begin assessing genetically engineered plants for their potential to become a “noxious weed.” BIO argued that APHIS already has that authority and “does not clearly articulate why it needs a second, different risk assessment system to evaluate noxious weed risk.” The agency, it said, was proposing “a significant and complex expansion to the way in which it determines which organisms are subject to regulation under 7 CFR Part 340.” CFR stands for Code of Federal Regulations.
NAWG CEO Chandler Goule said the association “looks forward to working with USDA regulators to create policies that will foster innovation and encourage the adoption of modern technologies that will enable wheat farmers to address climate, disease, and pest problems.”
And American Seed Trade Association President and CEO Andrew LaVigne said, “It’s important that the administration moves forward without delay in soliciting stakeholder feedback on policy around plant breeding innovation while actively engaging in the ongoing dialogue at the global level. Public and private sector plant-scientists around the world are investing in a great deal of research using newer methods like gene editing across a wide variety of crops -- with exciting potential for farmers, consumers and the environment. However, in order for these benefits to be fully realized, and widely adopted across breeding programs of all sizes and sectors, developers need clear, science-based, policy direction.”
Food & Water Watch Assistant Director Patty Lovera said she wasn’t surprised by the move to withdraw the proposal, adding that she’s not confident the Trump administration would propose regulations her group could embrace.
“The rules they were using were inadequate for the first generation of biotech,” she said. “There needs to be a whole new way of looking at biotech crops.”
Lovera suggested that APHIS take a close look at the issue of “genetic drift,” when pollen from a GE crop floats into the field of a neighbor who is growing organic or non-GE crops. “What are the odds that some of these crops are prone to genetic drift?” she asked. Organic and non-GE growers “feel all the risk falls on them,” she said.
Other issues that should be on APHIS’s radar screen include whether new GE crops may result in more chemical use or more herbicide resistance, she said.
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