EPA proposed rule provides exemptions for certain biotech plants

The Environmental Protection Agency (EPA) on Sept. 1 released a 142-page proposed rule for easing the regulatory process for plants that are engineered to kill pests, also known  as plant-incorporated protectants (PIPs).

Specifically, EPA would exempt from regulation biotech crops engineered to contain pesticidal substances if they:

• “pose no greater risk than PIPs that meet EPA safety requirements”; and
• “could have otherwise been created through conventional breeding.”

EPA’s proposed rule would require a developer to submit a self-determination letter or a request for EPA confirmation that the PIP is in fact eligible for exemption before it can engage in Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) regulated activities.

“Because developers of exempted PIPs will still be subject to FIFRA’s adverse effects reporting requirement and the recordkeeping requirement that is part of EPA’s proposed rule, EPA believes it is appropriate to require submission of a self-determination letter or a confirmation request…to enable EPA to monitor compliance with EPA’s regulations and to take action to avoid adverse health impacts, if necessary,” EPA noted.

The proposed rule is open for comment for 60 days.

This proposal follows the U.S. Department of Agriculture’s (USDA) implementation of a final rule published on May 14 for regulating plant-based agricultural biotechnology products if they pose a plant health or pest risk, which allows crop technology developers to make a “self-determination” that their plant technology is exempt from USDA regulatory oversight, with no notification required if they believe they should be exempt.