In the summer of 2015 the Obama Administration announced a process to update the regulatory system for biotechnology products. After a request for information a series of public consultation events started with an October meeting in Washington, D.C. It marks the first major update to the process since 1992. It is the first of three public sessions planned.
Earlier this week the dates and locations for the other two sessions were announced. One will take place on March 9 at the Environmental Protection Agency’s (EPA) Region 6 office in Dallas, and the other will take place on March 30 at the University of California in Davis. The specific details for how to participate will be available in the Federal Register soon, but I suspect that the process used at the October 2015 meeting will be instructive. You will likely have the opportunity to submit comments for up to two weeks following the meeting, whether or not you can attend.
Part of the process involves how best to clarify the roles and responsibilities of the EPA, the Food and Drug Administration (FDA), and the Department of Agriculture (USDA) in the regulation of biotechnology products. While this is a bit of an oversimplification, at present the EPA is involved with regulating these products as they relate to pesticides and applications of microbial technology. The USDA is interested in these regulations from the perspective of impacts on plant and animal health, and the FDA is concerned with genetically engineered foods, animals and other products under its domain derived from genetically engineered sources.
Following the three meetings and the associated public comment periods, the agencies will work on an update of their common regulatory framework. That update will also be subject to public review and comment. The timeframes for each of these steps will eventually be published in the Federal Register, most likely by the Office of Science and Technology Policy.
Today was the final day of an International Summit on Human Gene Editing, hosted at the National Academies in Washington. The event was sponsored by the Presidents of the U.S. National Academy of Sciences and National Academy of Medicine, the Royal Society of the United Kingdom, and the Chinese National Academy of Sciences.
The three day meeting led to a statement outlining four basic conclusions on how to approach gene editing for at least the near future. Some of the language should be familiar to anyone following discussions about emerging technologies dating back to at least the Asilomar conference of the 1970s that outlined how to approach research in recombinant DNA. The recommendations:
- Basic and preclinical research should proceed under appropriate legal and ethical rules and guidance on the following topics:
(i) technologies for editing genetic sequences in human cells,
(ii) the potential benefits and risks of proposed clinical uses, and
(iii) understanding the biology of human embryos and germline cells.
Any germline cells or embryos edited in the course of this research must not be used to facilitate a pregnancy.
- Clinical research and therapy on somatic cells (where the genomes of cells are not passed on to subsequent generations) can proceed under existing (and future) regulations covering gene therapy research.
The rationale behind this recommendation is that the limited impact of research and therapy on somatic cells makes the considerations of ethical and legal impacts comparable to other genetic therapies that do not use the editing techniques (such as CRISPR) discussed at the conference. Arguably humans have been using gene editing techniques for a few decades. However, the emergence of CRISPR and other techniques has improved the precision and speed of gene editing to the point where conversations about how to use these techniques (and when not to) should take place.
- Clinical research and therapy on germline cells (where the genomes of cells are passed on to subsequent generations) would be irresponsible until the relevant safety and efficacy issues are resolved and there is sufficient societal consensus that the proposed application is appropriate.
To date, the committee does not think any proposed gene editing research on germline cells has met either criteria. This is particularly true for the countries and jurisdictions that have bans in place for germline editing.
- An international forum on gene editing should be established to monitor and engage with the ongoing research in this area.
The event sponsors have expressed support for coordinating with other national science bodies to establish such a forum.
As researchers in China using CRISPR arguably prompted this effort to discuss uses of gene editing research it is encouraging to see the Chinese National Academy of Sciences playing a role in the discussion. Lacking an enforcement mechanism for implementing these suggestions, it may well fall to the soft power of persuasion from scientific institutions to apply the appropriate caution in working through the future of gene editing research.
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):
- What additional clarification could be provided regarding which biotechnology product areas are within the statutory authority and responsibility of each agency?
- 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?
- 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?
- 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?
- 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.
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.
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 http://www.chemicalprobes.org/, 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.
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.
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.