New Stakeholder Engagement on APHIS Biotechnology Regulation

This website is devoted to stakeholder engagement regarding APHIS regulation of the products of biotechnology. Please bookmark this site and return regularly for updates and information.

In a stakeholder message on February 27, 2015, and a Federal Register notice on March 4, 2015, the Animal and Plant Health Inspection Service (APHIS) announced the withdrawal of its 2008 proposed rule that would have amended the regulations for certain genetically engineered (GE) organisms.

The 2008 proposed rule generated comments from more than 88,300 commenters. Based on the experience we have gained over the past 28 years, continuing advances in biotechnology, and the scope of comments received on the proposed rule, we have withdrawn the proposed rule to begin fresh stakeholder engagement aimed at exploring alternative policy approaches.

Because of rules limiting ex parte communications with respect to active rulemakings, publication of the 2008 proposed rule constrained our ability to talk about alternatives with stakeholders. Withdrawing the proposed rule lifts this constraint, allowing APHIS to discuss regulatory issues in ways that were not possible while the proposal was in formal rulemaking. Our intention is to utilize an open and robust policy dialogue to drive the development of a forward-looking rule that will provide a foundation for our future regulatory activities.

This website will serve as a resource on upcoming engagement initiatives. That engagement will begin with a series of webinars to provide the stakeholder community an opportunity to provide initial feedback. There are three opportunities to participate in the webinars.

Wednesday, May 6, 6-9 pm EDT
Tuesday, May 12, 5-8 pm EDT
Wednesday, May 20, 4-7 pm EDT

Details on these webinars will be posted to this site as they become available. Please check back often for updates.

CONCURRENT USDA ACTIVITIES

In addition to APHIS’ engagement regarding 7 CFR parts 340 and 360, concurrently USDA is developing ways to improve coexistence among various agricultural sectors. For more information on these efforts, CLICK HERE.

Ex parte rules are designed to prevent unequal access or the perception of favoritism during the active rulemaking period occurring after a new rule is proposed.