You can improve US biotechnology regulation

posted in: Science & Society | 9

We invite you to provide your comments to the White House on how to improve US regulation of biotechnology. Learn more below, and add your voice to our letter to the White House.

The White House Office of Science & Technology Policy (OSTP) has announced a major effort to update the Coordinated Framework for the Regulation of Biotechnology. OSTP is seeking comments to inform the revisions. They especially need feedback from scientists, but comments from everyone are welcome.

Frank microphone
Bring the voice of science to improve US biotechnology regulation.

We encourage you to provide comments to OSTP on the questions below, and we invite you to sign a letter showing your support for thoughtful regulatory change. 

Because the federal comment website can be cumbersome, we will collect your comments and submit them on your behalf. The full list of questions asked by OSTP can be found in Federal Register Notice 80 FR 60414 and in Docket FDA-2015-N-3403.

  • Do you have examples or case studies highlighting experiences with the US biotechnology regulatory system? Have you experienced or observed any barriers to research involving biotechnology, or barriers to making products of biotechnology available to the public? How could the agencies reduce those barriers?
  • What would improve transparency, coordination, and efficiency of the regulatory system? How could regulatory agencies better communicate their roles and responsibilities both to scientists and to the general public?

We hope many scientists will take this opportunity to provide comments about biotechnology regulation. We want to scientists to have access to emerging technologies such as genome editing in order to address challenges in food and agriculture. Scientists in academia and small business have not been able to take advantage of biotechnology to solve challenges in food and agriculture. This is in part due to a confusing, burdensome regulatory system. The review of the Coordinated Framework provides scientists a special opportunity to speak to the White House and the regulatory agencies in the interest of enacting real change.

The first call for public comments ends on November 13, 2015 but we will continue to collect and submit your comments as the effort to update the Coordinated Framework progresses. There will also be at least 3 in-person meetings. The first is scheduled for October 30, 2015 near Washington DC from 9:30 am to 1:00 pm EST, and will be available via webcast. The other two meetings will likely be later this year or in early spring, with one meeting in the Midwest and one on the West Coast. Consider signing up for updates from the White House about the Coordinated Framework.

Frank president White House
Putting a friendly face on biotechnology in the White House and beyond.
Follow BFI Board:

The Board of Directors for Biology Fortified, Inc. is a four member board, whose members include Karl Haro von Mogel, Anastasia Bodnar, David Tribe, and Kevin Folta. To learn more, visit the Meet us page.

  • mem_somerville

    My entry on the form page, pasted here as well:

    As a peanut-allergic individual, I have heard for years that there was the possibility of a GMO allergen-reduced peanut that was in the lab. For example, in 2008, this article highlighted a potentially life-saving advance: http://www.wired.com/2008/11/peanuts-with-le/. With gene editing, this could become even easier to accomplish. But academic projects often wither because they cannot surmount the lengthy and expensive processes across multiple agencies that are required to move products from the labs to the hands of growers and consumers. This hinders our access to useful products.

    A single funnel for evaluation of novel traits (via any technology), would be easier to understand. Where the first step could be: no further evaluation required, as this item is unlikely to have health or environmental consequences that are any different from other items of this type. {I am using “items” instead of plants because I assume this new framework would also include animal traits.} If it does require more evaluation, as a peanut might for health related traits, a health trait pathway could then be triggered. If it was something like a fast-growing tree (not food related), an environmental evaluation pathway could be triggered. And each trigger should have a completion timeframe that is shorter and defined, so it is limited in duration and predictable. Then projects could be expected to move forward (or not), but not endlessly sit waiting as research team run out of funds, or need to move on.

    • This is exactly the type of comment they need to hear. Thank you so much for taking the time. Here’s hoping many others weigh in.

  • WeGotta

    If only the scientific community would weigh in on this question:
    What would improve the transparency, coordination, and efficiency of our food system?

    Or are you all more concerned about getting your research to market?

    • mem_somerville

      It’s fine to disagree that a single path instead of multiple agencies, and evaluation of all new traits in a refined and time-limited way, is better.

      Why don’t you show us your solution instead of just whinging.

      • WeGotta

        My solution is more in line with the following:

        -Permaculture (not just the food production aspect of permaculture but also in it’s ethical principles and its method of evaluating and constructing systems that seek to make things both easier (less inputs from us) and more productive (getting out more than just thing per system) while at the same time making the whole system more resilient.
        -Localization of food and finance.

        -http://thenextsystem.org/

        I wish scientists also wanted transparency on our food labels.

        • mem_somerville

          Oh, that’s cute for you and yours. And while you have your hobbies, the rest of us will be eating.

          • WeGotta

            Ah come on now. Is that scientific? Is that intellectually curious?

            Maybe all our scientists have lost their imagination from staring at genes and RNA strands all day. You all seem calcified.

          • WeGotta

            Gregor Mendel had a cool hobby.

    • If you have thoughts to share about the biotech regulatory system, including how it can be more transparent, I encourage you to share your comments.

      The food system at large is not the subject of this call for comments, but if you watch federalregister.gov you may see a call for comments for which these other thoughts would fit. You might also contact your congress persons.