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USDA Withdraws Proposal on Imports of Genetically Engineered Organisms

Wednesday, March 04, 2015
Sandler, Travis & Rosenberg Trade Report

The Department of Agriculture’s Animal and Plant Health Inspection Service has withdrawn a 2008 proposed rule that would have amended the regulations regarding the introduction (importation, interstate movement and environmental release (field testing)) of certain genetically engineered organisms. APHIS will instead begin a fresh stakeholder engagement aimed at exploring alternative policy approaches.

APHIS states that 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 eliminating the current notification and permitting procedures and developing a multiple-category permitting system in its place. APHIS received more than 88,000 comments on the proposal, which raised concerns such as the scope of the rule (some believed it was overly restrictive while others said it should be more far-reaching), what exactly would and would not be regulated, what future criteria might be used to determine what organisms would fall under APHIS regulatory jurisdiction, and oversight of crops that produce pharmaceutical and industrial compounds.

APHIS is now withdrawing this proposed rule based on the comments received as well as the experience it has gained over the past 28 years and continuing advances in biotechnology. APHIS notes that this step will allow it to discuss regulatory issues and alternatives in ways that were not possible while the proposal was in formal rulemaking. APHIS intends to utilize an open and robust policy dialogue to drive the development of a forward-looking rule that will provide a foundation for future regulatory activities.

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