The U.S. Dept. of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has announced proposed revisions to its biotechnology regulations in a notice published in the Federal Register on Jan. 19, 2017. 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. This would be the first comprehensive revision of the regulations since they were established in 1987.

According to the agency, the proposed rule 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 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.

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 (import, interstate movement, or environmental release).

APHIS’ proposed rule will be available for public review and comments will be accepted for 120 days beginning Jan. 19, 2017, through May 19, 2017. After the public comment period closes, the agency will decide how or whether to finalize the regulations based on its evaluation of public comments to the proposed revisions. Additionally, it will make available a draft programmatic Environmental Impact Statement (EIS) that it intends to publish for public comment soon.

Press release

About the proposed rule

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