What creative ideas do you have for the US biotechnology regulatory agencies? With the White House call for comments closing on November 13th, now is the opportunity to share. In this post, I’ll talk about one idea that will be in Biology Fortified’s comment – feel free to take it and run with it!
We’ve made it easy for everyone to provide comments to the White House, and you can learn more at our post: You can improve US biotechnology regulation.
There are tons of advisory committees across the US government. Why isn’t there one (or more) for biotechnology regulation? Let’s take a look at just a few advisory committees and see what they do.
- Risk Communication Advisory Committee (FDA) – Advises the FDA on “strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products”. Members include “authorities knowledgeable in fields such as social marketing, health literacy, and other relevant areas”. One has to wonder why this committee isn’t advising the FDA to do more risk communication about biotechnology! This committee is one of 33 FDA advisory committees, and the FDA’s parent department (Health and Human Services) has a few more.
- Chemical Assessment Advisory Committee (EPA) – Advises the EPA on “selected Toxicological Reviews of environmental chemicals”. Members are scientists in a variety of relevant fields. The EPA has so many committees that they have a Science Advisory Board to oversee all of them. This could be a useful model if there were multiple biotechnology advisory committees.
- National Genetic Resources Advisory Council (USDA) – Advises the USDA on “conserving and utilizing genetic resources for food and agriculture”. Their membership statement is particularly interesting: “Two-thirds of the appointed members represent the scientific disciplines relevant to NGRP, and one-third represent the general public in relevant activities. Thus, it is likely that each of the life forms in NGRP (plants, forest species, animals, aquatics, insects, and microbes) are represented by only one appointed scientific member.” This is of course just one of many USDA Advisory Committees.
These advisory committees and many more are formed under the guidance of the Federal Advisory Committee Act (FACA) of 1972. The General Services Administration (GSA) has a great overview: FACA 101. If you’ve never heard of FACA, prepare to be stunned. Under FACA, the President must provide an annual report to Congress about all of the advisory committees. So there’s a lot of data about the committees, their functions, their membership – and you can find it all at the FACA Database (if you are at all a policy wonk, you’ll want to set aside some time to peruse this database and follow the links out). In the 2014 report organized by function, you can see there are a ton of “Scientific Technical Program Advisory Boards” and many of the other boards also have some scientific focus (and I’m not even including the Grant Review function).
As you can see, there are a variety of committees that have a variety of types of interactions with the agencies they advise. Now, there has been some advisory committee work for biotechnology. For example, if I recall correctly, the now defunct Veterinary Medicine Advisory Committee reviewed AquaAdvantage salmon (because the increase in growth hormone was seen at the time as an animal drug). The other example that I know if is the USDA’s AC21. This advisory committee was originally convened in 2003 and has a focus on encouraging coexistence between agriculture that does and does not use biotechnology, but AC21 doesn’t seem to inform biotech regulation either in the grand sense of regulatory change or in the day-to-day sense of evaluating applications for field trials or for commercial release.
Do you think forming advisory committees for biotech regulation is a good idea? How many are needed? If more than one, how should the different committees interact, if at all? What sort of functions might such committees have? What types of experts should be on biotechnology advisory committees? Any people or professions who should be in or out? Let’s discuss!