About 2008 Proposed Rule

About the 2008 Proposed Rule for APHIS Biotechnology Regulations

On Oct. 9, 2008, APHIS published a proposal to amend the regulations for the introduction (importation, interstate movement, and environmental release (field testing)) of certain genetically engineered (GE) organisms in response to advancement in technology and accumulated experience in implementing the current regulations. The proposed revisions were extensive and included significant changes to the scope of the regulations and the mechanics of APHIS’ regulatory oversight. 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.  


The 2008 proposed rule generated 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 oversight of crops that produce pharmaceutical and industrial compounds and increased regulatory burden are just a few examples of the complex issues raised by commenters.

Based on the experience we have gained over the past 28 years, continuing advances in biotechnology, and the scope of comments received on the proposed rule, we have withdrawn the proposed rule to begin a fresh stakeholder engagement aimed at exploring alternative policy approaches.

View Documents Associated with the 2008 Proposed Rule


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