On June 6, 2019, the Animal and Plant Health Inspection Service (APHIS) proposed a significant restructuring of the agency’s regulations governing genetically-engineered organisms.  Public comments on the proposal are due by August 6, 2019.  APHIS’s proposed changes, which will increase the number of genetically-engineered organisms that may be produced without undergoing APHIS review, are likely to be of interest to biotechnology companies, agricultural organizations, and other entities interested in genetically-engineered organisms.

Under the Plant Protection Act, APHIS has broad authority to regulate “plant pests,” including many genetically-engineered (“GE”) organisms.  Regulated GE organisms are subject to a variety of restrictions, including a general requirement that APHIS review and permit the movement of the GE organisms, including any release into the environment.  7 C.F.R. § 340.4.

Currently, APHIS regulates “regulated articles,” a term that includes any organism that is itself a “plant pest,” or where the gene donor, recipient, or vector (i.e., an organism used to transfer genetic material) is a “plant pest.”  A plant pest, in turn, is any invertebrate, fungus, or microorganism that can directly or indirectly injure or cause disease in plants or plant products.  40 C.F.R. § 340.1.  Thus, under current regulations, if any genetic material is taken from a plant pest, or a microorganism that is a plant pest is used as the vector agent in the genetic engineering process, the resulting GE organism would be considered a plant pest.

The proposed rule would significantly alter this structure, and would generally regulate GE organisms only under the following circumstances:

  • The GE organism itself is a plant pest;
  • The GE organism received DNA from a plant pest, and that DNA is capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease;
  • The GE organism is a microorganism used to control plant pests, or an invertebrate used to control invertebrate plant pests; or
  • The GE organism is a plant that has a plant-trait-mechanism of action combination that has not been evaluated by APHIS (i.e., if APHIS has already reviewed the biochemical basis for the new trait and approved its use for another plant, another review would not be required. APHIS intends to make such completed reviews publicly available on its website.).  APHIS has requested comment on whether the exemption for already-reviewed trait-mechanisms of action should be extended from plants to include other types of organisms.

As a practical matter, these changes will increase the number of GE organisms that may be produced without undergoing review by APHIS.  For example, GE organisms using genes from microorganisms that are plant pests will not be subject to review solely on the basis that the genes came from a plant pest.

APHIS is also providing a formal pathway for developers to request confirmation that their GE organisms are outside the scope of the revised regulations.  While that would not be mandatory, APHIS notes that developers who do not request and receive such confirmation run the risk of being subject to agency enforcement action if the agency disagrees with their assessment.  Proposed Rule at 14.

APHIS takes the view that these changes would create a more “efficient regulatory pathway for innovators, facilitating the development of new and novel genetically engineered organisms that are unlikely to pose plant pest risks,” and would provide cost savings to the biotechnology while not decreasing the level of protection provided against plant pest risks.  Proposed Rule at 79.

This approach is in contrast to the proposed rule released on January 19, 2017, which would have presumptively regulated any GE organism, subject to certain exceptions, and would have required detailed risk assessments of many GE organisms.  Some commenters argued that this approach would be burdensome, and the Trump Administration withdrew the proposed rule on November 7, 2017.