USDA Publishes Proposed Revision of Biotechnology Regulations

Dudley W Hoskins Posted on 01/18/2017 by Dudley W Hoskins

Early today, U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced proposed revisions to its biotechnology regulations in a notice that will soon publish in the Federal Register. The proposed rule updates the regulations in a number of areas, all within the Agency’s current statutory authority under the Plant Protection Act passed into law in 2000.  The proposed rule is based on the best available science, will better enable APHIS to focus its resources on regulating genetically engineered (GE) organisms that may pose plant pest or noxious weed risks, and will enhance regulatory flexibilities that stimulate innovation and competitiveness. 

In developing the proposed rule, APHIS carefully considered comments received during public scoping and comment periods related to withdrawal of a 2008 proposed rule, as well as comments relative to a March 2016 notice of intent to conduct a programmatic environmental impact statement, recommendations made in two Office of the Inspector General audits, recent advances in biotechnology, provisions in the 2008 Farm Bill, and the Agency’s accumulated experience in implementing the current regulations.  This would be the first comprehensive revision of the regulations since they were established in 1987. 

APHIS is proposing a regulatory program in which it first assesses GE organisms to determine if they pose plant pest or noxious weed risks.  If APHIS concludes that a GE organism does not pose a plant pest or noxious weed risk, then APHIS would not require a permit for the importation, interstate movement, and environmental release (outdoor use) of the GE organism.   On the other hand, if APHIS determines, based on risk analysis that controls on movement are needed, APHIS will work with the requestor to establish appropriate permit conditions to manage identified risks to allow safe movement. By “movement” APHIS means import, interstate movement, or environmental release (regulated controlled outdoor use such as in field trials.)

GE plants that are not engineered with plant pest sequences do not fall under our current regulations even though they may pose noxious weed risks.  APHIS is proposing to implement the noxious weed authority to close this gap.  APHIS’ goals for the proposed revisions are to ensure a high level of plant health protection based on the best available science; improve regulatory processes so that they are more transparent, efficient, and predictable for stakeholders and the public; and provide regulatory relief that will stimulate innovation and competitiveness.

APHIS’ proposed rule will be available for public review and comments will be accepted for 120 days upon publication in the Federal Register. After the public comment period closes, we will decide how or whether to finalize the regulations based on our evaluation of public comments to the proposed revisions. Additionally, APHIS will make available a draft programmatic Environmental Impact Statement (EIS) that APHIS intends to publish for public comment soon, and APHIS looks forward to stakeholder input. APHIS also intends to have public meetings on the proposed rule during the comment period.   Additional information is available on the APHIS-BRS website here.

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