Biotechnology regulation update

There are two upcoming opportunities to learn about the US regulatory system for biotechnology. Both have web-based options so you can attend from anywhere in the world. Check out the topics below and be sure to register! One is next week, on November 7th, and one is on December 3rd.

Biotechnology Regulatory Service

The USDA-APHIS-Biotechnology Regulatory Service (BRS) is holding their annual Stakeholder Meeting on Wednesday, November 7th,10:00 am to 3:30 pm Eastern. Register for the Stakeholder Meeting in advance, and select the webcast option. If you are in the Washington DC area, there is also an option to attend in person.

During the morning session, BRS will “discuss implementation of business process improvements; review biotechnology research, education, and outreach”. During the afternoon session, they will present the new APHIS eFile system. The afternoon session will be of particular interest to any researchers whose work (movement or field trials of certain genetically engineered organisms) is regulated by BRS; you will need to use the new eFile system in 2019.

BRS will provide opportunities for questions. It will be interesting to see if they discuss the FDA’s Plan (below). Another potential topic of interest not on their agenda is whether they will propose regulatory changes in 2019 “to respond to advances in genetic engineering” aka gene editing, regulate GE organisms that present a possible noxious weed risk, and respond to Office of the Inspector General audits, among other issues. Note that if you have questions about the USDA’s proposed Bioengineered label, BRS is not the agency to ask. Labeling is handled by the Agricultural Marketing Service (AMS).

Food and Drug Administration

The Food and Drug Administration (FDA) announced on October 30th their new Plant and Animal Biotechnology Innovation Action Plan. They are holding a webinar on Monday, December 3rd, 12:00 pm to 2:00 pm Central. Register for the Genome Editing in Animals meeting in advance. This meeting is webinar only, with no in-person option.

During this meeting, FDA’s Center for Veterinary Medicine (CVM) and Center for Biologics Evaluation and Research (CBER) will discuss risks and benefits of gene editing in animals. FDA will also discuss “CVM’s flexible, risk-based approach to the regulation of intentional genomic alterations in animals and address common misconceptions associated with the regulation of these products”.

When you register, there is an option to “submit any questions that you have regarding genome editing in animals and CVM’s regulation of animal biotechnology.” Definitely use these three boxes to submit your questions in advance, and help show the FDA what types of concerns the regulated community has on their mind. Note that while FDA does regulate genetically engineered plants, they specify the “webinar will not cover genome editing in plants for human and/or animal food”.

As you consider questions to ask FDA, it may help to think about gene editing like a text editing program – it can delete, replace, and insert, among other functions. Many gene edited organisms will have no new proteins, and potentially no new DNA at all. How will FDA treat each of these different results? What will the regulatory trigger be? How will FDA regulate gene edited animals with no transgenic DNA, or animals where gene editing was used only to delete DNA?

Gene edited animals

cow with hornsOne example of a gene edited animal is hornless dairy cow. While horns are useful in the wild, you can imagine that horns can be dangerous for cows and for the humans that tend them. There are naturally hornless cattle but they lack other traits that are important for dairy cows.

Researchers used gene editing to replace a gene in horned cattle with one from hornless cattle. The result? Hornless dairy cows that don’t need to go through a potentially painful de-horning process. Depending on how the FDA decides to regulate gene edited animals, that little piece of cow DNA, which is already in the food supply anyway, could be regulated as an animal drug.

In addition to cattle, gene edited animals include pigs, sheep, goat, tilapia, carp, and chicken. Edits have been made for improving agricultural traits, for medical research, and even for making fancier pets. Each of these different animals will need to be evaluated differently before they can be released either into the food supply or otherwise out of the laboratory.

Need some background in gene editing? Check out highlights from a 2018 symposium about gene editing hosted by the Crop Bioengineering Center at Iowa State University, which include what gene editing is, what it can do, how it is regulated, and consumer acceptance of new technology in food.

Follow Anastasia Bodnar:
Anastasia is Policy Director of Biology Fortified, Inc. and the Co-Executive Editor of the Biofortified Blog. She has a PhD in genetics with a minor in sustainable agriculture from Iowa State University. Her favorite produce is artichokes!