The next meeting of the Presidential Commission for the Study of Bioethical Issues (Commission) will be in Washington, D.C. on May 3. There is one more Commission meeting scheduled after the May meeting, and that may be the last Commission meeting before it finishes its work (and President Obama leaves office).
I base that in part on this Federal Register notice the Commission released last month (which states the Commission has two more meetings) and on the agenda for the May 5th meeting. That agenda is focused on the past, present and future influence of national bioethics advisory bodies. The Commission will discuss the topic with several academics and the head of the Commission’s Mexican counterpart, CONBIOÉTICA.
The Commission is also interested in input from you. The Federal Register notice the Commission released last month was a request for comments on:
- The advantages and disadvantages of different models for national bioethics advisory bodies, e.g., standing or temporary, narrowly or broadly focused (examining one topic or issue or a variety of issues);
- The lessons we can learn from national bodies in other countries to inform how U.S. bodies might work;
- The influence of national bioethics bodies on bioethics as a field; other academic fields, such as science, medicine, and technology; and public policy;
- The future of national bioethics advisory groups in the United States.
Comments must be received by July 1.
Presumably the Commission is consulting with the International Network for Governmental Science Advice (INGSA), I certainly think that INGSA would be interested in the comments and any reports or other documents to come from them and the meeting on May 5th.
The National Institutes of Health (NIH), the Howard Hughes Medical Institute and the Wellcome Trust are co-sponsoring the Open Science Prize. The first phase of the prize competition closes on February 29. The purpose of the project is to encourage the development of open science tools and services that can make it easier for users to access and re-use datasets and other research outputs from biomedical research.
Successful teams must include at least one member from the U.S. and one member from another country. They will compete for one of up to six awards of $80,000 that would allow teams to further develop a prototype of a product or service that helps further open science. In the second phase of the competition selected teams would submit those prototypes and the winning one receives a $230,000 award. For more information, consult the website and the webinar prize organizers held in December.
Today the federal government released its proposed budget for Fiscal Year 2017. (The year is scheduled to start on October 1st, but this budget isn’t likely to be passed until close to calendar year 2017.) But it wasn’t the only government release of note.
One item that caught my attention is in the Worldwide Threat Assessment that the U.S. Intelligence Community issued by the Director of National Intelligence James Clapper (H/T MIT Technology Review). On page nine of the report (page 13 in the digital file) there is reference to recent meetings in the U.S. and Europe that express concern over the unregulated use of genome editing technology. CRISPR is not named in the report, but that specific technology was the focus of at least one international meeting.
The concern expressed in the report is on the relative ease and reduced cost of being able to conduct the work. The deliberate or unintentional misuse of this technology could pose national security risks depending on the applications. The report lists genome editing in a section on weapons of mass destruction (WMD), which suggests that the intelligence community is concerned about this work either being weaponized or (more likely) used to develop particularly nasty biological material.
While the report notes that there are still technical hurdles in existing genome editing systems, I think the mention of genome editing as a technology worth monitoring by the intelligence community raises some new regulatory interests, at least in the U.S.
Genome editing technologies could be classified (at some point in time, if not now) as dual-use and therefore subject to additional scrutiny. There currently exists a government policy for life sciences dual-use research of concern, but it is focused on particular biological agents and/or toxins and CRISPR or comparable genome editing technologies would only qualify if the purpose of such experiments or the agents and/or toxins already is covered by the policy.
And I think this is a challenge with genome editing. As I understand it, the advantage of CRISPR and comparable technologies is radically improving the speed and accuracy of what is already being done. That may change if the new genome editing technologies demonstrate the ability to do some kind of genome editing previously impossible. We aren’t there yet, but the intelligence community thinks that time is on the horizon.
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.