This post is on an open comment period held by APHIS, an agency within the USDA, titled Movement of Certain Genetically Engineered Organisms. I know it’s a mouthful, which is why I’m going to deconstruct it here. APHIS has been the main regulatory agency for biotechnology and GMOs since 1987. If you need a refresher on them or genetically engineered (GE) food, you can read this post or this one. The goal of this proposed regulation is to reduce the burden for developers of genetically engineered organisms and to facilitate the development of new ones.
APHIS requires permits or notifications, together called authorizations, as part of the process to introduce new GE organisms. Permits require special conditions such as labeling, record keeping, item separation, inspections, and disposals of packing material and shipping containers. They also include performance standards applicable to shipping, environmental release, and field trials. If it’s determined that the organism doesn’t pose a plant pest risk, then a notification is required, which is less stringent.
Once a developer can show that a GE organism poses no more risk than a non-GE version, they can petition for non-regulated status. Since July 1992, APHIS has granted 130.
This proposed rule would expand non-regulated status to include plants that could be produced through traditional breeding techniques and plants with mechanism of action (MOA) combinations that have already been evaluated. (An MOA is basically the biochemical process of how a gene is expressed.) It would eliminate notifications altogether, leaving permits and non-regulated plants. It would also allow developers to self-determine whether their GE plant belongs to an exempted category.
Some of these changes were expected from the USDA. The proposed rule follows a statement by Secretary Perdue that the USDA does not plan to regulate plants that could have been developed through traditional breeding techniques. This has indicated that APHIS is looking to shift focus onto properties of the GE organism itself rather than on the method used to produce it. Also expected is the exemption for MOA combinations that have already been evaluated. APHIS has been evaluating organisms for three decades and has a large body of data and experience to work with.
What is unexpected is the provision putting a significant amount of decision-making in the hands of developers rather than the USDA. The proposed rule does state that developers who make a self-determination that APHIS deems invalid may be subject to remedial measures or penalties. Enforcement will have to be seen, but with the agency’s animal welfare inspection reports no longer online, there is no guarantee that the process will have transparency.
This proposed rule is APHIS’s third attempt at overhauling the authorization system since 2008. The first attempt received thousands of comments expressing concern about the expansion of regulatory authority. The second attempt received a couple hundred comments that proposed requirements would be too burdensome and had the potential to stifle innovation. Third time’s the charm, right? They have since conducted outreach to Land Grant and public university researchers, as well as small-scale biotechnology developers, agriculture innovators, and other interested stakeholders.
To give a sense of scale, in the past year APHIS has granted about 19,500 authorizations for environmental release of GE organisms, 14,000 authorizations for the importation of GE organisms, and more than 12,000 authorizations for the interstate movement of GE organisms. They have also denied about 1,600 authorizations, usually due to insufficient information. They’re a busy agency.
Something to keep in mind is that APHIS gets it’s authority to regulate GE organisms from the Plant Protection Act, passed in 2000. What does this mean? Well, GMOs are a contentious topic that covers a wide range of issues including allergens, antibiotic resistance, gene transfer, and economic impact, among others. APHIS isn’t really concerned with this. They are here to regulate products based on the risk of plant pests. While it’s possible that they may take other factors into consideration, it isn’t their priority.
If any of the issues I listed are a priority for you, please add your view into the mix. I hope you feel informed enough to leave a comment. They are due by August 6th.