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2008 Proposed Rule for APHIS Biotechnology Regulations

On Oct. 9, 2008, APHIS published a  proposed rule that would have amended the regulations at 7 CFR part 340 regarding the introduction (importation, interstate movement, and environmental release) of certain genetically engineered organisms.  These changes included aligning the regulations with provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.) and eliminating the current notification and permitting procedures and developing a multiple-category permitting system in its place.


APHIS received comments from more than 88,300 commenters. Many commenters indicated that the proposed scope and many of the provisions of the rule were unclear. With regard to the scope of the proposed changes, some commenters asserted that APHIS regulations needed to be more rigorous and far-reaching, while others believed that the proposed regulations were overly restrictive. Other commenters indicated that they were not clear as to what would and would not be regulated, and raised concerns regarding what future criteria might be used to determine what organisms would fall under APHIS regulatory jurisdiction. Concerns regarding increased regulatory burden were also raised by commenters.


On February 27, 2015, USDA APHIS withdrew the proposed rule to begin a fresh stakeholder engagement aimed at exploring alternative policy approaches.


View the 2008 Proposed Rule  


View the Draft Environmental Impact Statement for the 2008 Proposed Rule


Search for Federal Register Notices Associated with the 2008 Proposed Rule 


Learn More About Public Meetings for the 2008 Proposed Rule 




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