Proposed Rule for Biotechnology Regulations 340

Engagement on APHIS Biotech Regulations

May 2015 Stakeholder Engagement on APHIS' Biotechnology Regulations

This website is devoted to our efforts to revise APHIS' regulations of the products of biotechnology at 7 CFR part 340. Please bookmark this site (press Ctrl + d) and return regularly for updates and new 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 gained over the past 28 years, continuing advances in biotechnology, and the scope of comments received on the proposed rule, we withdrew the proposed rule to begin fresh stakeholder engagement aimed at exploring alternative policy approaches.

Because of rules limiting ex parte1 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 lifted 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. 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 go to and enter docket number APHIS-2015-0036.

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?

On November 18, 2015, a possible new proposed rule was discussed at the annual stakeholder meeting of APHIS' Biotechnology Regulatory Services.  Transcripts and related materials can be found here

On February 5, 2016, APHIS  published a notice in the Federal Register announcing that it is developing a draft programmatic environmental impact statement (EIS), required under the National Environmental Policy Act, that will evaluate a range of alternatives that the Agency can take as it works to update its biotechnology regulations.  The notice also invites the public to comment on the range of alternatives that APHIS will study in the draft EIS, along with definitions that APHIS plans to use in the draft EIS.  For more information, see our Stakeholder Announcement.


In addition to APHIS’ efforts to revise the regulations at 7 CFR part 340, USDA is concurrently working with its regulatory partners at EPA and FDA to implement enhancements to existing regulatory processes outlined in a memorandum issued by the Executive Office of the President (EOP) titled "Modernizing the Regulatory System for Biotechnology Products," by increasing transparency and predictability, while providing a framework for assessing advancing innovation consistent with the efforts to revise its biotech regulations.  For more information on the modernization of the Coordinated Framework, click here.

USDA is also developing ways to improve coexistence among various agricultural sectors through the Secretary's Advisory Committee on Biotechnology & 21st Century Agriculture (AC21). For more information on AC21, click here.

1Ex 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.

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