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Withdrawal of 2008 Proposed Changes to 7 CFR part 340

On February 27, 2015, APHIS announced the withdrawal of its 2008 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.

APHIS Announces Withdrawal of 2008 Proposed Rule for Biotechnology Regulations

Questions and Answers: Withdrawal of Proposed Rule Regarding the Introduction of Certain Genetically Engineered Organisms (340 Regulations)

Federal Register Notice (March 4, 2015):  Withdrawal of 2008 Proposed Rule for Biotechnology Regulations

Learn about our new stakeholder engagement on the future of APHIS biotechnology regulation.


History

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.  

Public Comments

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.


Federal Register Notices Associated with the 2008 Proposed Rule

March 4, 2015 Federal Register Notice on Withdrawal of 2008 Proposed Rule for Biotechnology Regulations

April 13, 2009 Federal Register Notice on Public Meeting

March 11, 2009 Federal Register Notice on Scoping Meeting and Extension of Public Comment Period

January 16, 2009 Federal Register Notice on the Proposed Biotechnology Regulatory Revisions

November 10, 2008 Correction Notice to the Proposed Biotechnology Regulatory Revisions

October 9, 2008 Federal Register Notice on the Proposed Biotechnology Regulatory Revisions


Press Releases Associated with the 2008 Proposed Rule

April 8, 2009 Press Release on Public Meeting

March 6, 2009 Press Release on Scoping Meeting

January 15, 2009 Press Release on the Proposed Biotechnology Regulatory Revisions

October 6, 2008 Press Release on the Proposed Biotechnology Regulatory Revisions


Documents Associated with the 2008 Proposed Rule

Transcript from April 29-30, 2009 Public Meeting

Transcript of March 13, 2009 Public Scoping Meeting

Transcript of October 6, 2008 Media Call on the Proposed Regulatory Revisions

Proposed Biotechnology Regulatory Revisions Questions and Answers

Proposed Biotechnology Regulatory Revisions Factsheet




Additional Information