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.