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.

So, There Was This Week Of Making…

Happy Canada Day, everybody!

The U.S. held its first National Maker Faire on June 12 and 13 in Washington, D.C.  It was part of a week-long celebration of Making, which included a few other events of interest.

The Faire was well attended by federal agencies and senior leadership from the Office of Science and Technology Policy.  There was also a showcase of Makers from Historically Black Colleges and Universities, and the White House announced commitments from several educational institutions to expand efforts to support makers at their institutions.  Companies, state and local governments have also announced commitments to support Makers.  A long list of the commitments announced is available online.

I was struck in particular by the commitments from the U.S. Patent and Trademark Office (USPTO) and the National Institute of Standards and Technology (NIST) to help Makers in commercializing their products.  As you might have guessed, the USPTO will assist Makers in protecting their intellectual property (though some Makers may be more interested in Creative Commons-type limited rights).  NIST will help Makers through the Manufacturing Extension Partnership (MEP).  The MEP has Centers set up to assist small and mid-sized manufacturers with business and technical assistance, and will make those same services available to Makers.  (There was likely nothing preventing Makers from doing this already, but the commitment should demonstrate an understanding of Making that may not have previously existed at the MEP.)

 

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.)

Next PCAST Meeting Returns To NITRD And Ponders Getting Older

The next meeting of the President’s Council of Advisors on Science and Technology (PCAST) takes place on July 14 at the National Academies in Washington, D.C.  While this is not on a Friday (as has been the custom) the public portion of the meeting will still be from 9 a.m. to noon Eastern time.  No agenda is available at this time at the PCAST website, but the Federal Register notice provides some indication of what will be discussed.

The PCAST will discuss its review of the Networking and Information Technology Research and Development (NITRD) program.  PCAST is obligated to do this review periodically, and the next report would be its third during the Obama Administration.  Also scheduled for the meeting are presentations on aging and for human spaceflight.  My past experience suggests that comments on space exploration will dominate the public comment session scheduled for the meeting.

You will be able to view the meeting live on the 14th, through the usual webcast provider.  A more detailed agenda should be available by the beginning of July.

National Library Of Medicine Urged To Lead More On Data

Last week National Institutes of Health (NIH) Director Francis Collins approved a report on a new strategic vision for the National Library of Medicine (NLM) (H/T ScienceInsider).  The Director requested the report at the beginning of the year, and it arrives not quite 3 months since the retirement of NLM Director Donald Lindberg, who led the Library since 1984.

NLM is responsible for a number of program related to medicine and health-related data.  PubMed is perhaps the best known outside of the biomedical community, but NLM operates many other health-related databases, physical artifacts and other records.  But the report calls fro NLM to be more of a leader in biomedical information across NIH, the federal government, and internationally.  This will include an expansion of NLM activities in data science and biomedical informatics, and the Library will need to be systematic and considerate in how it expands while continuing to deliver quality service to its many stakeholders.

The report contains specific suggestions about how NLM could expand its offerings and improve its services.  For instance, it suggests that the Big Data to Knowledge program be located in the NLM.  But with the Library needing a new Director, many of these actions will likely wait until that person is on board, and can determine the necessary adjustments to resources and personnel to implement these recommendations.

In Case The American Community Survey Disappears

Earlier this month members of the House voted to cut funds from the Census Bureau in order to support other projects in the same Appropriations bill.  Coupled with the persistent efforts to gut the American Community Survey and it seems likely we may need to prepare for a future where this resource may not be available.

That may seem like a daunting task, but I think it’s not impossible.  I say this because of the effort of Nathan Yau, who has created a 2015 version of the Statistical Atlas of the United States.  He wasn’t happy that the Census Bureau was not producing a new edition of the Atlas (or of the Census Atlas it released based on 2000 Census data).

It’s a lovely piece of work, and if he had some extra help (and/or more time), I think Yau, or other data scientists, could take the raw data and create updated versions of statistical resources providing need context to policy decisions and other important questions.  But without the data that the American Community Survey can provide, we all lose.