Title: Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms

Docket ID: APHIS-2015-0057

Agency: USDA, Animal and Plant Health Inspection Service

Comments Close: May 19, 2017



APHIS is doing their first comprehensive revision of their original 1987 regulation, to reflect changes in genetic engineering (GE) technology that have occurred over the past 30 years. The agency is particularly concerned with two primary updates: 

  1. To reflect advances in genetic engineering, and genetic engineered organisms. Most of the evaluations reviewed by the agency have shown that the use of a plant pest as a vector, vector agent, or donor, <i> does not</i> necessarily mean that the GE organisms presents a plant pest risk. In contrast, with the evolution of new technologies such as genome editing and synthetic genomics, GE organisms that are not currently regulated may have plant pest risks. 
  2. To address gaps in regulation related to certain weedy plants. There has been an increase in the use of plants that have "weedy" traits prior to being genetically modified. Genetic engineering can enhance this "weediness." APHIS is concerned that their current regulatory structure does not allow them to properly identify all risks presented by these plants, and that under the current regulatory structure, these potential noxious weeds may entirely escape regulation.

There are a multitude of other reasons cited to overhaul the existing regulations; we go into more details on these in the “Regulation Actions” section. Briefly, they include: (3) To address audits from the Office of the Inspector General, (4) To regulate non-vertebrate GE biological control agents, (5) To correct a technicality in the proposed regulation that might leave outdoor planting of certain GE organisms unregulated, (6) To shift federal oversight of small-scale outdoor plantings of certain GE organisms to the EPA, and (7) To better synchronize corresponding APHIS and EPA decisions.



As stated above, this is the first time since 1987 that APHIS is doing a comprehensive revision of these regulations. However, APHIS has previously amended the regulations six times. 

A very helpful clarification: A "plant pest" is any living stage of a variety of organisms that can direct or indirectly infect or damage any plant, any part of a plant, or any plant product. These “pests” include invertebrates (ie. insects, mites, or protozoa), bacteria, fungi, parasitic plants, viruses, and other similar organisms. Infectious agents or substances which can also cause disease or damage are also considered “pests."



Since this is a comprehensive revision, there are a wider range of regulatory actions than can be summarized succinctly here. We strongly suggest selecting "Learn More" below. Many of the nuances of this proposal lie in defining what the agency considers a genetically engineered organism (i.e. the organisms which need to be assessed by APHIS),  identifying which of these genetically engineered organisms need to be regulated, and the ensuing restrictions of the regulated organisms (including permitting, notifications, shipping containers).  Nearly all of these are altered in the new proposed regulations. 

APHIS is specifically requesting comments on several regulory actions. 

  1. Regulation of plants that produce plant-made industrials and pharmaceuticals (PMPIs). With the other adjustments made in this proposal, some, if not all, genetically engineered PMPIs that are currently under APHIS permits would no longer be regulated. As a result, these plants could be grown outdoors without the need for permits or oversight. APHIS proposes several actions to remedy this, which you can review here
  2. Synchronous decisions with the EPA regarding herbicide-resistant genetically-engineered. APHIS is responsible for the deregulation of herbicide-resistant plants, whereas the EPA is responsible for registering the associated herbicide. In many cases these processes are not completed at the same time, which APHIS recognizes can lead to significant problems. APHIS provides several approaches to more effectively coordinate with the EPA, which you can read here

Contributor: M.S. Student, Molecular Ecology