US biotech regulation public comments

October 30, 2015 was the first of three public meetings to collect ideas about how to improve US biotech regulation and how the agencies conduct public outreach. You can get updates from the White House, and get notified about the next meeting. This post describes why comments matter and who should comment.
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

Why update the Coordinated Framework?

Generalized visual representation of the Coordinated Framework for Regulation of Biotechnology.
Generalized visual representation of the Coordinated Framework for Regulation of Biotechnology.

In his opening remarks, John Holdren said* that government needs to simultaneously fund scientific research and foster a regulatory environment that encourages innovation while protecting human health and the environment. To accomplish these tasks, the original 1986 Coordinated Framework for Regulation of Biotechnology did not create new authorities. Instead, it described how existing agencies would use existing authorities to regulate biotechnology.
The White House issued an update to the Framework 5 years and 8 months later, in 1992. This document advocates an approach where level of regulation is appropriate to the level of risk, but it appears to have been largely ignored. Unfortunately, they stopped there, and the Framework hasn’t been updated for 23 years and 8 months.
Holdren said the White House initiated this new conversation about the Coordinated Framework for 2 main reasons:

  1. Biotech science has advanced, posing new benefits and new risks.
  2. The regulatory system is confusing both for developers and for the public.

And they have 3 tasks in mind:

  1. Produce an updated Coordinated Framework document. This won’t actually update the regulations themselves, but can set new ways for the agencies to coordinate and conduct outreach.
  2. Develop a long term strategy for the agencies to improve the regulations.
  3. Commission an expert analysis with the National Academies of Science, gathering information to help make sure any the regulatory updates can be flexible with changes in technology.

After Holdren spoke, Robbie Barbero (also from the White House Office of Science and Technology Policy) provided additional background about the Coordinated Framework, then representatives from the USDA, EPA, and FDA provided very useful information about how the current biotech regulations work and how the agencies interact. The full transcript should be up soon, and we will update this post when the link becomes available.

Why do comments matter?

Overview of the steps it takes to get a regulation published. Click to visit a site with detailed explanation of this map.

Remember Schoolhouse Rock? They covered how a bill becomes a law, but the process of publishing a regulation can be even more complicated and just as fraught with potential political barriers. This diagram is The Reg Map, which shows the steps a potential regulation must take to get published. As you can see, it takes time and a lot of different people weigh in. This map doesn’t even show the deliberation that happens within an agency before a potential regulation enters Step One. An alternate overview of Notice and Comment Rulemaking that does include steps prior to proposed rule publishing was developed by the Center for Effective Government.

In a recent post on University of Pennsylvania Law School’s Reg Blog, Congressional Productivity’s Impact on Regulatory Agendas, Alex Acs describes some of the ways that regulatory agencies and congress interact in order to publish (or not publish) new or changed regulations. It all comes down to competing priorities of the agencies, the departments, the White House, and Congress. Many agencies have a backlog of regulations that they need to update, but there is only so much time. They also have to decide which changes might have the political will throughout the system to get it pushed all the way to final publication.

Comments are a way for the public to add their thoughts to the mix. If an agency starts the rulemaking process, they are hoping the political will is there to get to publication – and your comments can help them keep going. In the case of biotech regulations, an update just hasn’t been enough of a priority. The primary voices for this subject are a few somewhat small companies (yes, I said small, in comparison to other companies such as Wal-Mart and Exxon) and a few activist groups. Your comments can help show greater diversity of interest.

Who comments, and who should comment?

Public comment periods typically result in comments from those who have the money and time to spend – industry and activist groups. Take a look at the public comments that were made in response to a recent call for comments from the Biotechnology Regulatory Services at the USDA. There’s multiple petitions from activist groups that want more regulation or even outright bans of GMOs, signed by thousands of people, many of whom provide enlightening comments such as “Stop GMOs.” All of these comments are duly read and tallied up, but they don’t really provide much useful information.
Unfortunately, a combination of poor advertising of comment opportunities, a lack of time, and in some cases a lack of awareness means that people who will be directly affected by a government action do not comment. In this case, the affected people are scientists who may want to bring biotech products to market. It’s not just scientists, though! Farmers want new biotech traits such as citrus greening resistance, that could help them use less inputs. People at both domestic and international aid agencies, might want to bring improved crops to hungry people. Environmentalists, especially ecomodernists, want to reduce our impact on nature through smart use of technology. And last but not least, we have members of the public who want to better understand biotechnology – they can share their ideas on how the agencies can do a better job on public outreach.
Biology Fortified is concerned that this call for public comment about the Coordinated Framework will result in just another set of bland industry comments and incendiary (and often profane) yet un-useful activist comments. We implore you to help encourage the agency leadership to keep moving forward by signing our letter and to provide thoughtful comments through our easy-to-use form.

Public comments: Round 1

Screenshot of the list of commenters.
Screenshot of the list of commenters. Click to embiggen.

There were 20 people pre-registered to speak at this meeting. The ratios of professions and ratio of “pro GMO” to “anti GMO” were actually a lot better than I expected – but we still haven’t heard much from the people we really need to hear from.
Here’s how these commenters stack up:

  1. If we look at their professional training, we have 10 scientists, 2 social sciences, 2 journalists, 2 lawyers, 4 unknown, 0 farmers. However, of those 10 scientists, few if any are actually actively publishing research or trying to get products of biotechnology to market.
  2. If we look at their ideological stance, we have 9 “anti GMO, 10 “pro GMO”, and 1 unknown (yes, this is a rather crude classification). However, at least 3 of the “pro GMO” commenters are actually pro synthetic biology and may or may not actually be concerned with the sort of GMOs we usually think of when someone says GMO. One of the “anti GMO” commenters is more concerned with synthetic biology.
  3. If we look at the organizations represented, on the “anti GMO” side we have 7 activist groups while on the “pro GMO” side we have 2 scientific societies, 1 activist group / think tank, 2 law firms, 1 biotech company, and 1 agriculture trade group (and 6 commenters that are not representing an organization or information not found).

And here is the full list of commenters. I did my best to find links to a self-created bio and the organization homepage for each one; if you find a better link, let me know in the comments. I encourage you to read the transcripts for each commenter once they are available.

  1. Steven Druker, Alliance for Bio-Integrity, Absent, but comment read by OCA representative.
  2. Richard Engler, Bergeson & Campbell, PC
  3. Doug Gurian Sherman, Center for Food Safety
  4. Michael Hansen, Consumers Union
  5. Ryan Lee, Cornell University (Alliance for Science), Absent. Unsure if commenter was there as an individual or as a representative of the organization.
  6. Shah Nawaz, Department of Energy & Environment, Absent. Unable to find information about this commenter or group.
  7. Tim Schwab, Food and Water Watch
  8. Sapna Brown, Governance Solutions, Unable to find information about this commenter or group.
  9. Kelly Drinkwater, iGEM Foundation
  10. Val Giddings, Information Technology & Innovation Foundation
  11. Jaydee Hanson, International Center for Technology Assessment
  12. Claire Marris, King’s College London, Absent. Unsure if commenter was there as an individual or as a representative of the organization.
  13. Randy Gordon, National Grain and Feed Association
  14. Marek Cuhra, University of Tromso, Norway, Based on his LinkedIn profile, the commenter is no longer with the University thus probably not representing them.
  15. Nina Federoff, OFW Law
  16. Alexis Baden-Mayer, Mothers Across America / Organic Consumers Association
  17. Megan Parker, none
  18. Megan Palmer, Stanford University, Unsure if commenter was there as an individual or as a representative of the organization.
  19. Terry Medley, DuPont
  20. Tyrone Spady, American Society of Plant Biologists

Of all of these commenters, I think Kelly Drinkwater was the most successful. She was clearly passionate about her topic (synthetic biology) and provided a concrete example of how the biotech regulatory agencies could do better: the FBI knows that DIY biohackers could pose a risk so instead of ignoring them, they specifically engage the community and get people to self-regulate. She also invited the agencies to the iGEM Jamboree. I think that she (and the other speakers who mentioned synthetic biology) are right and that the new Coordinated Framework needs to be more clear on how synthetic biology is addressed.
* The transcript hasn’t been released yet, so none of these are direct quotes. Any mistakes in what people said are unintentional and may be corrected later.

1 comment

  1. I received a kind email from Bruce of the Center for Regulatory Effectiveness, informing me that this post was shared on their ORIA Watch website.
    He said, “I highlighted your post both because of the importance of its subject and because it supports our goal of helping educate the public about the White House’s crucial role in developing and approving federal regulations.”
    OIRA refers to the White House Office of Information and Regulatory Affairs, and the non-profit Center for Regulatory
    Effectiveness (CRE) focuses on the White House’s centralized regulatory review function. “The CRE was started by former senior career officials from theWhite House Office of Management and Budget and we act an independent regulatory watchdog. More information about CRE may be found here,”
    Bruce also said: “To help support our educational goal, we have developed The OIRA Teaching Module providing a the basis for a graduate level course in centralized regulatory
    review. We have also announced a student writing contest to encourage research on centralized regulatory review,
    He asked that I let biotech students who are interested in the regulatory process know about the OIRA Teaching Module and the student writing contest. So go check it out!

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