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:
- Inadequate transparency and
implications for the credibility and integrity of U.S. biotechnology review
- Flawed concept and questionable acceptability of “confirmation letters”.
- Implications for disruptions of field trials.
- Lack of international acceptance of recognition of APHIS’s regulatory approach.
- Need for coordinated action by U.S. Government agencies in promulgating rules and guidance on genome editing and other forms of plant breeding innovation.
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.
- APHIS should secure international recognition
or acceptance of its regulatory approach toward assessing plant pest risk before
proceeding to finalize its Part 340 rule.
- 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.