USDA APHIS Part 340

On August 6, 2019,  thanks to the leadership of the  National Grain & Feed Association NAEGA and several colleague trade associations submitted comments in response to the U.S. Department of Agriculture Animal and Plant Health Inspection Service’s (APHIS) proposed revisions to regulations under 7 CFR Part 340 applicable to the movement of certain genetically engineered organisms. The comment noted significant deficiencies and major recommendations to assist in improving Part 340:

Deficiencies:

1. Inadequate transparency and implications for the credibility and integrity of U.S. biotechnology review process.
   1. Flawed concept and questionable acceptability of “confirmation letters”.
   1. Implications for disruptions of field trials.
   1. Lack of international acceptance of recognition of APHIS’s regulatory approach.
   1. Need for coordinated action by U.S. Government agencies in promulgating rules and guidance on genome editing and other forms of plant breeding innovation.

Major recommendations:

1. APHIS is urged  to amend its Part 340 proposed rule to require all technology providers to notify the agency in advance before introducing gene-edited or other plant breeding innovation traits for commercialization – even those within APHIS’s expressly exempted categories – so that the agency can issue an official approval letter for all traits that do not present a plant pest risk.
   
   
2. APHIS should secure international recognition or acceptance of its regulatory approach toward assessing plant pest risk before proceeding to finalize its Part 340 rule.
   
   
3. Third, APHIS should not proceed to issue a final rule on Part 340 until its sister agencies – the U.S. Food & Drug Administration and the U.S. Environmental Protection Agency – develop and issue guidance and/or rules on how they plan to address genome editing and other plant breeding innovation technologies within their respective areas of jurisdiction under the Coordinated Framework. 

Text of the comments can be found here.