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October 6, 2017
Inside EPA Quotes B&C Memorandum on EPA, FDA Jurisdiction for Mosquito Related Products

On October 6, 2017, Inside EPA quoted a recent Bergeson & Campbell, P.C. (B&C®) memorandum in the article “EPA wins power to oversee biotech mosquito controls.”

EPA and the Food and Drug Administration (FDA) have issued new guidance clarifying that EPA has authority for regulating biotechnology (Bt) products such as genetically modified mosquitoes that are used to control the pests, a step that one industry law firm says will be helpful for navigating a federal “jurisdictional quagmire."

[…]

In an Oct. 5 blog, the law firm Bergeson and Campbell PC, which advises industry clients on various chemicals and biotechnology issues, says the guide offers helpful clarification for developers of certain Bt products.

The firm says that the guidance likely responds to regulatory uncertainty Oxitec, Ltd. faced in seeking a field trial of its genetically engineered Aedes aegypti mosquito designed to prevent reproduction of the insects. FDA originally considered the product designed to limit viability of offspring as an animal drug, according to the blog.

But under the new guidance, such items will be overseen by EPA.

“The Guidance is a welcome addition to the growing body of work generated by federal agencies intended to assist stakeholders in sorting out the challenging jurisdictional issues that often arise in the context of procuring federal agency approval of products of biotechnology and synthetic biology,” the law firm says.

See - https://insideepa.com/daily-feed/epa-wins-power-oversee-biotech-mosquito-controls (subscription required)


 
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