White House Launches Effort To Revise Biotechnology Regulation

While I find the timing suspect, on Thursday John Holdren, Director of the White House Office of Science and Technology Policy (OSTP), announced (along with other senior White House staff) the Administration will be reviewing the Coordinated Framework for the Regulation of Biotechnology, the policy that designates agency responsibilities for overseeing the introduction of biotechnology products into the environment (H/T Grist).  First developed in 1986, the last revision was in 1992.  So, clearly overdue.

Holdren’s announcement accompanied a memorandum to the Environmental Protection Agency, the Department of Agriculture and the Food and Drug Administration.  It (along with Holdren’s blog post) outlines the elements of the review process:

  • Updating the Common Framework (with public input) to clarify the biotechnology product areas (not processes) for which each agency will be responsible.  This will include how to handle situations where more than one agency may be responsible.
  • Developing a long-term strategy (with public input) to ensure that the Federal regulatory process will be better prepared for emerging biotechnologies.  This would include horizon scanning exercises and additional support of so-called ‘regulatory science.’
  • An independent examination of the future landscape of biotechnology.  The National Academies have already been engaged to start this analysis.

This all sounds great, but there are some aspects of this that give me pause.  First, the announcement comes the afternoon before the July Fourth holiday weekend.  It screams news dump – an effort to ensure that very few people become aware of the effort.

Additionally, while the revisions and the strategy will involve public input, Holdren asks for people interested in additional information to register.  If this wasn’t already part of an announcement that seems timed to minimize public reception, I might not think much of it.  But I can see the Administration limiting its subsequent publicity on this project to the people who register.  If they are going to try and hold listening sessions around the country (the first one will take place this fall), I think they should spread their message far and wide.

Finally, I guess I’m still a bit chagrined from other efforts to revise (or develop) regulations related to science and technology research.  The effort to revise the Common Rule related to human subjects research stalled out after a big public comment push in 2011.  And it still seems as though the push on scientific integrity policies has failed mainly from a lack of coordinated follow-through from the OSTP.

I’d love to see this not happen with the revisions to the Coordinated Framework, but I’m not optimistic – especially with roughly 18 months to go with this Administration.

Adventures In Wildlife Infrastructure

While developing artificial means to help wildlife do what they need to do has been a thing for a while (see fish ladders in dams), there are two current projects that strike me as something new.

In Oslo work is underway for a ‘bee highway.’  It’s not an actual road in the sky for the exclusive use of bees.  It’s a series of rooftops with flowers and the bee equivalent of rest stops.  The project is a collaboration between state bodies, local homeowners and companies, and you can track its progress online (you’ll need a translator or a working knowledge of Norwegian).

In the State of Washington work has been proceeding on helping wildlife cross a section of Interstate-90 in the Snoqualmie Pass region.  Earlier this month the state’s Department of Transportation started work on a wildlife overpass along a natural migration route to Keechelus Lake (The Interstate follows the northeast side of the lake).  Large fences along the highway near the overpass should help nudge bear, deer, elk and other fauna over the highway and on to the lake.  The overpass should complement the wildlife underpasses already being used in the vicinity and make it easier for migration and a broader genetic exchange.  Think of it as analogous to the parks being developed along unused elevated train tracks, if those parks were over major highways or surface streets.

The projects are not solely for the benefit of wildlife.  The crossings will cut down on more traditional surface crossings of Interstate-90 and the associated destruction.  This also facilitates a widening of the Interstate.  The overpass should be ready for nature traffic in 2019.

Commissioner Moedas Wants A Funding Council For Innovation

As part of a conference on the European Research Area (ERA), Commissioner for Research, Science and Innovation Carlos Moedas gave a speech (H/T ScienceInsider).  As part of his remarks, he discussed starting a second era for The ERA and the ‘Innovation Union.’

Commissioner Moedas is concerned about how effectively European Union member states have been commercializing the results of their research.  It’s not a problem unique to Europe.  Finding sufficient funding to take research results and create commercially viable products is always a challenge in part because the perceived investment risks often dissuade potential investors.

Institutional support can help facilitate commercialization, and one means the Commissioner would like to have at the ready is a European Innovation Council (possibly) modeled after the existing European Research Council.

I include the (possibly) because while I understand the urge to duplicate a successful organization for a slightly different purpose, a funding organization for research is not necessarily going to be as effective for funding innovation.  If the goal is to make it easier for private companies to invest in promising research, regulatory changes may be more effective than a funding council geared toward supporting potential innovators and/or innovative companies.  Hopefully this kind of examination will take place (if it hasn’t already) between now and 2017, when this possible Council will be discussed during the mid-term review of the Horizon 2020 research programme.

There are other things worth following in the Commissioner’s speech.  Two things that I will be very interested in watching are his proposal for a European Research Integrity Initiative and the idea of developing a research data repository for the EU.  (I don’t think putting it in the cloud is necessarily the greatest idea, at least not without serious access control provisions.)

My Comments On The Next National Action Plan For Open Government

Earlier this month I noted that the White House is seeking input on its third iteration of the National Action Plan for Open Government.  You can submit comments via email or on a Hackpad collaborative platform (you will have to register on Hackpad to submit via that platform).

Guidelines are pretty broad, and the Hackpad provides some categories to guide submissions.  The organizers have populated many of the pages with content from an Open Sunshine Week brainstorming event in March.  Since I mouthed off about submitting comments on the National Action Plan related to scientific integrity policies, I thought I’d share what I submitted (via the Other Topics section of the Hackpad platform).

“The Office of Science and Technology Policy (OSTP) should commit to collecting information on federal agencies compliance with their scientific integrity policies (including OSTP’s own scientific integrity policy).  The public should be able to view information on how many complaints each agency receives, a brief description of the claims, and the disposition of each case.  Additional details on scientific integrity cases should be available on request from OSTP, with appropriate exceptions consistent with open records laws.”

It’s not terribly detailed, but it’s at a level of detail consistent with other submissions on the platform.  Ideally, there should be a website where interested members of the public can get information on how agencies have been implementing their scientific integrity policies.  I’m not proposing a massive data dump of information, but to have enough summary information that interested parties can pursue additional information with the agency.  It would also, I hope, prompt the Office of Science and Technology Policy (OSTP) to continue monitoring the issue across the government.  It seems that once the agency policies were posted, the OSTP acted like the job was done.  But it’s only just started, and having a public reminder of that strikes me as a good thing to do.

National Academies Encourage Expansion Of Science And Technology Advice At State Department

Tomorrow, June 17, the National Academies will host a press briefing on a new report, Diplomacy for the 21st Century: Embedding a Culture of Science and Technology Throughout the Department of State. The report is available online, and you can access the report electronically for free (with a National Academies Press account, which is also free).

This report follows on the 1999 National Academies report The Pervasive Role of Science, Technology, and Health in Foreign Policy.  The 1999 report prompted the Department to re-establish a scientific advisory capacity in the form of a Science & Technology Adviser to the Secretary of State (the acting adviser is Dr. Frances Colon).

The report calls for an expansion and elevation of this capacity throughout the Department.  The Science & Technology Adviser should be given the status equivalent of an Assistant Secretary (currently the Adviser reports to the Under Secretary for Economic Growth, Energy and the Environment, and most of the other positions reporting to this Under Secretary are Assistant Secretaries).  There should also be a Science and Technology Advisory Board of independent experts.  The Board would provide advice on science and technology issues (non-defense) that would affect the Department’s foreign policy agenda.

Additional report recommendations (Chapter Six details all of the report’s findings and recommendations) seek to further integrate science and technology expertise into the Department.  The report encourages (among other things) the inclusion of science and technology in foresight exercises (it considers the current use of science and technology advice to be focus on short-term questions and challenges); connecting with in-country American scientists, engineers and health professionals; reviewing and expanding (as appropriate) staff with scientific and technical expertise; and expand training opportunities to include the value of science and technology to the Department’s mission (whether or not the trainee is a science or technology specialist).

The full report is worth reviewing and digesting.  Whomever becomes the next Science & Technology Adviser to Secretary Kerry will likely be critical to the implementation of the recommendations in this report.  Hopefully that person has been identified, or will be soon, as the position has been vacant for nearly a year.

U.S. Government Ramping Up To Open Government National Action Plan Version 3.0

The White House posted this call for input on the third iteration of its National Action Plan for Open Government.  Version 1.0 came out in 2011, and version 2 was released in 2013.  Aside from supporting the Administration’s interests in making government data more available, the Plan is part of the U.S. commitment as a member of the Open Government Partnership.  At this point, the comment request is informal.  You can submit them via email, Twitter, or through a Hackpad collaborative tool.  (You’ll need to register on Hackpad to participate there.)

Comments can expand on existing initiatives in the National Action Plan or suggest new ones.  These plans emphasize transparency and increased public access to information (in usable formats).  Given the language in the current plan around citizen science, crowdsourcing, and whistleblower protections, I think it would be a good idea to suggest something about incorporating scientific integrity policies into the National Action Plan.

If you’re looking for guidance on suggestions, the Open Government Partnership has its own data portal, the Explorer.  There you can review submissions from all the participating countries.  You can also see the commitments governments have made and how well they have delivered (at least on some of them).

Thankfully Someone Is Thinking About The Tech Transition

We are still 20 months away from the next Presidential administration, but I don’t think it’s too early to consider how government technology will be handled over the transition.  Thankfully the Chief Technology Officer, Megan Smith, has been thinking about this as well.

At a recent technology conference in Washington D.C., Smith indicated that at least for the technology teams currently supporting federal agencies, she intends to have them continue for whomever the next President will be.  These teams, including the U.S. Digital Service and 18F, are focused on delivery of services for government agencies and to the public.  I think it would be valuable to ensure that the smooth delivery of government services can avoid any hiccups due to a change in administration.  Hopefully Smith and her staff can avoid any legal pitfalls in communicating with presidential campaigns (and eventually the transition team for whomever becomes the 45th President) about the needs for continuity of government at the level of services.