The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced on February 27, 2015 that it is officially withdrawing a six year-old proposal that originally sought to substantially amend the agency’s decades-old regulatory program governing the introduction of certain genetically engineered (GE) organisms into the environment.  The 2008 proposal, among other key changes, would have expanded the scope of GE organisms subject to APHIS regulation while establishing a new and comprehensive permitting system to replace APHIS’ current notification and permitting procedures.  It now has been formally withdrawn so that APHIS can “begin fresh stakeholder engagement aimed at exploring alternative policy approaches.”  A brief overview of APHIS’ withdrawal action follows.

The 2008 Proposal

APHIS’ current regulations over GE organisms are published at 7 C.F.R. Part 340, consistent with the agency’s authority to regulate “plant pest” organisms under the Plant Protection Act (PPA).  When originally issued in 1987, these regulations addressed most of the then-existing genetic engineering technologies, which frequently involved the use of modified plant pests such as Agrobacterium to transfer new genes to plants.

However, as APHIS explained in its 2008 proposal, technological advances had “led to the possibility of developing GE organisms that do not fit within the plant pest definition, but may cause environmental or other types of physical harm or damage covered by the definition of noxious weed in the PPA.”  73 Fed. Reg. 60008, 60011 (Oct. 9, 2008).  Accordingly, APHIS proposed to expand the scope of its regulatory program beyond plant pests, consistent with its additional PPA authority over noxious weeds.  The proposal also sought to eliminate the program’s separate notification procedure for the introduction of eligible GE organisms without a permit, and instead would have placed all Part 340 authorizations under a single, comprehensive permitting procedure.  Notably, APHIS’ 2008 proposal did not suggest any changes to the definition of the term “genetic engineering” itself, which is defined under Part 340 to mean “the genetic modification of organisms by recombinant DNA techniques.”

Withdrawal of the Proposal and Next Steps 

APHIS reports that it received over 88,300 comments following publication of the 2008 proposal.  Specifically highlighting concerns raised by commenters in connection with the agency’s proposed changes to the scope of APHIS oversight and its permitting system, APHIS explains that as a first step following the proposal’s withdrawal it plans to announce a series of public webinars on this subject.  According to APHIS, it intends to use an “open and robust dialogue,” along with “new scientific knowledge,” to drive the development of future regulatory or policy approaches.

Although noting that its current regulations “have been effective in ensuring the safe introduction of GE organisms,” APHIS explains that it is now considering new revisions to update its existing regulations in light of advances in science and technology and that reflect its own experience over the last several decades.