Tell The Government How To Update Its Biotechnology Regulations

Back in July the Office of Science and Technology Policy (OSTP) announced that it would be leading an interagency effort to review and update the Coordinated Framework for the Regulation of Biotechnology (Framework). Part of the effort would include soliciting public input on both updates to the Framework and the development of a long-term strategy for dealing with emerging biotechnologies.

Last week the OSTP published a Request for Information (RFI) in the Federal Register seeking that public input.  The submission deadline is 5 pm Eastern time, November 13.

Here are the questions listed in the RFI (the product areas and agency roles are summarized in the RFI and available in the Background section of the memorandum sent to agencies on this effort):

  1. What additional clarification could be provided regarding which biotechnology product areas are within the statutory authority and responsibility of each agency?
  2. What additional clarification could be provided regarding the roles that each agency plays for different biotechnology product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment?
  3. How can Federal agencies improve their communication to consumers, industry, and other stakeholders regarding the authorities, practices, and bases for decision-making used to ensure the safety of the products of biotechnology?
  4. Are there relevant data and information, including case studies, that can inform the update to the CF [Coordinated Framework] or the development of the long-term strategy regarding how to improve the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?
  5. Are there specific issues that should be addressed in the update of the CF or in the long-term strategy in order to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?

While submissions can be submitted by regular mail, electronic submission is preferred.  Please see the Federal Register notice for additional information.

Petitions And GMO Labeling – Waiting For The FDA

One of the petition responses released this summer from the Obama Administration concerned the mandatory labeling of food containing genetically modified organisms (GMOs).  I want to emphasize the mandatory part of the last sentence, as the Administration’s response emphasized the voluntary labeling that presently exists.

The Administration’s response also deferred to the Food and Drug Administration (FDA), which is presently considering two petitions about mandatory labeling for food containing GMOs.  As best as I can tell, no final decision has been made in the 10 weeks since the Administration released its petition response in late July.

The Administration also deferred to the FDA and other agencies concerning the ongoing effort to update federal regulations on biotechnology.  As I posted in July, that process has just started, so the Administration’s response, while seemingly supportive of the concerns over making sure consumers know what food is produced without GMOs, the policy actions have not (yet) supported that sentiment.

Wellcome Supports Effort To Crowdsource Review of Chemical Probes

Nature Chemical Biology has published a Commentary on its website about chemical probes.  These are important tools in biochemical research for their ability to explore the function of proteins in broader contexts.  The commentary notes the increased utility of these probes and how their use has increased over the last few years.

But there are problems.  These chemicals are difficult to produce in high quality, and lower quality probes lead to poor results.  To try and mitigate those problems, the commentary authors have developed a crowdsourced resources for information on high-quality chemical probes and how to use them (H/T ScienceInsider).  Online at, the site is supported by The Wellcome Trust, and endorsed by The Broad Institute, The Institute for Cancer Research, and the Structural Genomics Consortium.

The site provides information, and can connect interested parties with the experts behind the website.  This includes suggesting new chemicals for inclusion on the site.  While there is not yet an online submission process, those using the feedback mechanism on the site can make suggestions to the reviewers.

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.

A Step Towards Standardizing DNA Sequencing

Last month The New York Times reported that the National Institute of Standards and Technology (NIST) has developed a reference standard for use in DNA genetic sequencing.  Specifically, NIST has made available genetic material that can be tested to confirm that a lab would find the known mutations in the proper places when sequencing the reference material.  This would help assure the reliability of the testing at that lab.

By providing this testing standard, labs will be able to better demonstrate the reliability of their tests, which should stimulate demand for the tests, and may make insurance companies more likely to pay for them.  This might help address the concerns agencies like the Food and Drug Administration have had about direct-to-consumer genetic testing – at least where reliability is concerned.

While this is the first NIST reference material for genetic sequencing, it has developed reference materials for other DNA tests and procedures.  Those reference materials, developed by NIST’s Applied Genetics Lab, are usually smaller amounts of DNA, often produced via Polymerase Chain Reaction and targeted to tests looking at specific genetic sequences.

Lab Issues Go Beyond The Really Nasty Bugs

Recently federal labs have come under scrutiny for failing to effectively control the quantities of nasty bugs like anthrax they have in stock.  Unfortunately, that is not the extent of the problems facing National Institutes of Health (NIH) facilities.

The NIH has closed its Pharmaceutical Development Section, which produces pharmaceutical drugs for its clinical trials (H/T Nature News).  After investigating a complaint, the Food and Drug Administration (FDA) found the Section failed to comply with standard operating procedures and had serious manufacturing problems.  The problems included finding fungal contamination and insects in manufacturing facilities, and insufficient dress for lab staff.

While the Section is closed, an external expert group will convene to conduct a thorough review.  Participants in clinical trials are being notified about the possible contamination of the drugs being tested, and some are requesting exemptions in order to continue taking the drugs.  The NIH has promised the FDA a corrective action plan by June 19.

Agencies Want Help With Dengue Forecasting

Today the U.S. government announced the beginning of a forecasting project on Dengue Fever.  The Centers for Disease Control (CDC), the National Oceanic and Atmospheric Administration (NOAA), and the Armed Forces Medical Surveillance Center (AFMSC) have made available datasets on Dengue fever from Puerto Rico and Peru.

This data, when coupled with environmental and climate data from the area and associated climate models, should allow scientists the ability to forecast the emergence of Dengue outbreaks.  Interested parties will have four months (until September 2) to use this data to develop their forecasting models.  An evaluation team will decide on the finalists (up to six teams), who will be invited (on their own dime, regrettably) to appear before the Interagency Pandemic Prediction and Forecasting Science and Technology Working Group of the National Science and Technology Council.

This is not a competition in the now-traditional sense of a short term contest with a cash prize.  Project organizers, according to this description, are looking to publish the evaluations, and all those who submit will have their predictions included.  Team leaders will be invited to receive author credit.

For more detailed information on submission procedures and project rules, consult the Dengue Forecasting Project portion of the Epidemic Prediction Initiative (EPI) website.  The EPI is a product of the Department of Health and Human Services Idea Lab, and is currently in beta.