Gene-edited sterile-insect approach advances in trials, faces unclear U.S. review pathway

A St. Louis biotech told a House Agriculture Committee hearing that a gene-edited sterile insect approach being developed to suppress pest populations runs into regulatory barriers because current law and guidance are written for chemical pesticides.

Lede: "AgriGene's PG SIT technology ... uses modern gene-editing tools like CRISPR to precisely and reliably edit the genes responsible for fertility and female viability," Brian Witherby, AgriGene's chief executive, told the committee. "These males are healthy, competitive, and self limiting."

Nut graf: Witherby said the technology has been tested in controlled settings at multiple land-grant institutions and shows potential as a targeted alternative to repeated pesticide sprays, particularly against soft-fruit pests such as spotted wing drosophila (SWD). But he and other witnesses said regulators lack a clear, risk-proportionate review pathway for precision biological controls, leaving innovators to navigate both EPA and USDA reviews.

Details: Witherby described PG SIT as a modernized sterile insect technique that avoids radiation-based sterilization and instead produces sterile males through targeted gene edits. He said university trials in Washington, California, Oregon, Michigan and Minnesota are underway and that uncontrolled outbreaks of pests such as SWD cause major economic damage. "Spotted winged Drosophila is one of the most economically damaging invasive pests ... The annual economic impact from SWD in North America alone is around a billion dollars," Witherby said.

Regulatory issues: Witherby and other witnesses argued that current statutes and agency guidance were framed for chemicals and older biological approaches. As a result, companies developing precision biological tools face duplicate or poorly aligned reviews at EPA and USDA and long timelines that can be fatal to small startups.

Policy recommendations: Witherby urged Congress to modernize statutes and create science-based, risk-proportionate pathways that recognize the unique properties of gene-edited biological pest controls, enhance interagency coordination, and support preapproval field validation so tools are available quickly if an outbreak occurs.

Ending: Members asked about investor incentives, university partnerships, and what statutory or appropriations steps Congress could take to accelerate safe, species-specific biological controls to protect specialty crops and livestock.