Agencies Continue to Modernize Biotech
Federal Officials Grapple with Future of Agriculture Biotechnology
OMAHA (DTN) -- Federal agencies continue to look for ways to simplify the regulatory process for agricultural biotechnology in response to a June 11 executive order from President Donald Trump.
There are a number of steps USDA, EPA and the Food and Drug Administration continue to pursue, representatives of those agencies said during a Farm Foundation forum at the National Press Club in Washington, D.C., on Tuesday.
Ahead of the executive order, the USDA proposed a rule on June 5 that would allow crops produced with GM techniques with a long, low-risk history of safety within the industry to bypass USDA's regulatory process in the future. Crops produced with gene-editing techniques such as CRISPR-Cas9 would also continue to be nonregulated, as long as they do not pose a plant pest risk.
Officials with the FDA and EPA provided some insight on the work they are doing in response to the executive order, as well.
Mike Mendelsohn, chief of EPA's emerging technologies branch in the biopesticides and pollution prevention division of the office of pesticide programs, said the agency is considering a couple of different rulemaking possibilities.
EPA regulates all pesticides marketed and used in the United States, including those produced with biotechnology techniques.
Mendelsohn said EPA is considering a rule to simplify and improve the regulatory process. In addition, he said the agency also is considering a streamlined review process for plant-incorporated protectants, or PIP.
PIPs are pesticide substances produced by plants and the genetic material necessary for the plant to produce the substance. One example is that scientists can take the gene for a specific Bt pesticidal protein, and introduce the gene into the plant's genetic material. The plant then manufactures the pesticidal protein that controls the pest when it feeds on the plant. Both the protein and its genetic material are regulated by EPA.
"Whatever action we consider will be consistent with our science-based regulatory system," Mendelsohn said.
Laura Epstein, senior policy advisor in the office of the center director at FDA's center for veterinary medicine, said FDA requires pre-market approval for GM animals unless they are determined to be low-risk. The agency is planning a rewrite of the application process and a public outreach, she said.
The agency has fielded questions about whether farms that produce GM animals will be subject to registering with FDA.
"Farms raising animals are not drug manufacturing facilities and do not have to register with FDA," Epstein said. "They're not required to report adverse events and they do not need FDA approval to breed animals with IGA (intentional genomic alterations)."
Still, livestock groups such as the National Pork Producers Council are pushing for USDA to play a regulatory role overseeing GM animals, or animals that have been bred following gene-editing techniques. NPPC sees FDA's current process to regulate gene modifications as too onerous to be practical. NPPC recently launched "Keeping America First in Agriculture" to establish new guidelines for regulating gene-edited livestock.
Fan-Li Chou, biology coordinator in the office of pest management policy at USDA, said at the forum that the agency's role in biotechnology is multi-faceted.
"Our job is to provide our farmers access to tools they can use," Chou said. "We need to ensure that agriculture biotechnology tools are safe and effective. We need market access for agriculture biotechnology products. It is broader than just regulatory. Regulations should respect new knowledge. In last few years I thought the speed of science was slow. But the speed of regulation is even slower than science."
In addition, she said the agency has its eye on how governments around the world regulate biotechnology.
"A lot of countries have already made policy to determine if precision plant breeding is subject to their regulation," Chou said. "We're moving to ensure compatibility globally. From a legal perspective, most countries define what a GMO is. Countries make legal determinations on whether products are in or out."
Stanley Abramson, an attorney with Arent Fox LLP in Washington, D.C., said the agencies need to strike a balance between making sure biotechnology products are safe and making them available on the market as soon as possible.
Abramson said federal agencies need to select the right level of product oversight and address duplicate reviews of biotech products.
"The new generation of products will yield greater benefits in the short-term and is all done without evidence the products hurt the environment or human health," he said. "An unnecessarily regulatory climate could prove very costly. There could be lives lost and lost ecological resources."
Todd Neeley can be reached at email@example.com
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