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 (press Ctrl + d) 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past 28 years, continuing advances in biotechnology, and the scope of comments received on the proposed rule, we have withdrawn the proposed rule to begin fresh stakeholder engagement aimed at exploring alternative policy approaches.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 engagement began with an opportunity to provide oral and written comments on the questions listed below through June 22, 2015. Oral comments were taken in a series of webinars in May 2015. Transcripts and related materials from these webinars may be found on the Documents page of this website.  To review the comments received on this docket (APHIS-2015-0036) at, click here

APHIS sought input on the following questions:

    1. Should APHIS regulate based on the characteristics of biotechnology products and the potential risks they may pose, or by the process by which they were created?  In either case, what criteria should be used to determine what APHIS regulates? Are there products and processes APHIS should not regulate?

    2. The Plant Protection Act gives APHIS the authority to protect plant health through regulatory programs. APHIS has implemented the plant pest authority as part of their biotechnology regulations.  Should APHIS add noxious weed provisions to their to biotechnology regulations and if so, how?  What protection goals should APHIS consider? 

    3. Are there legal authorities given to USDA outside the Plant Protection Act that APHIS should examine to regulate or oversee the products of biotechnology? What are they, and how would they be used?
    4. What non-regulatory solutions or policy alternatives could or should be considered to complement APHIS’s regulatory program?



In addition to APHIS’ engagement regarding 7 CFR part 340, 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.