HGP-Write A Wish List In Plan’s Clothing

In the latest issue of Science is an immodest proposal from a number of genetic researchers for what they call The Genome Project – Write, or HGP-Write.  The name evokes a kind of CD recording media while staking ground for what would be a groundbreaking achievement – a dramatic reduction in the cost of engineering and testing large genomes (up to 100 billion base pairs) by over 1000-fold in the next ten years.

If I understand the proposal correctly – which is questionable as this reads more like the first draft of a roadmap rather than a project proposal – the ultimate goal of synthesizing a human genome would be accomplished after a great deal of work at smaller scales.  But widespread genome synthesis is still quite new.  For instance, the CRISPR suite of tools for more targeted genome editing are still under scrutiny for how they are being used and questions remain unanswered about how they should be used.

The proposal comes soon after a private meeting involving many of the authors to discuss HGP-Write.  The closed-door nature of the meeting and relatively small numbers involved prompted concerns and likely led to what one of the principals, George Church, calls a misunderstanding over what the project intends.  While genome synthesis is the goal, according to Church it is not intended to create humans out of whole cloth.

I think misunderstandings like this will make it harder for the project to get the $100 million in research commitments it seeks for 2016.  If HGP-Write wants to avoid some of the pitfalls that have faced dramatic technology changes such as genetically modified organisms, future meetings should be more public, and the conversations about the project need to be thoughtful and thorough about future applications and implications of the changes they want to make happen.

A short outline of HGP-Write is the start of the beginning, not the beginning of a project.

Congress Likely To Punt On National GMO Labeling Legislation

Vermont passed a law in 2014 requiring that grocery food labels will need to declare if the products contain ingredients that were genetically modified.  The law is scheduled to go into effect on July 1, even with a pending lawsuit in federal court.  As the market in Vermont is relatively small, it is not economically feasible to print labels just for products sold in Vermont, which will effectively make the Vermont labeling law a national standard…

Unless Congress does something by July 1, or other states enter the labeling space and offer their own bills.

As you might guess, the chances of Congress acting by the deadline are relatively slim.  An effort to prevent state GMO labeling laws failed in March.  There are efforts underway to find a way forward, but with a limited number of legislative days before July 1, there might not be enough time.  Given that the Secretary of Agriculture and major food producers are interested in a national standard (if for no other reason than to avoid a patchwork of several different state laws), I think this is another example of the willingness of Congress to not do its job (see the annual tragedy of the budget process for the first, best example of this negligence).

For the record, my personal position on this is much like what the General Mills executive outlined in the blog post I cited earlier.  I think GMO food products have been demonstrated as safe for human consumption, but I also think it reasonable to label products with GMO ingredients.

Oprah Attached To Star In Henrietta Lacks Project

Oprah Winfrey has been involved in trying to get a film adaptation of The Immortal Life of Henrietta Lacks made since the book was published in 2010.  The film, an HBO Productions film, will start shooting this summer, and this week it was announced that Oprah will star.

Oprah will play Lacks’ daughter Deborah and the story is told from her perspective, as Deborah learns about her mother and how the harvesting of Henrietta’s cells led to many medical breakthroughs.  Rebecca Skloot, author of the book, is co-executive producer, and three members of Lacks’ family are serving as consultants to the film.  George C. Wolfe will direct.  No release date is available, though sometime in 2017 would make sense for what will likely be a television release (it’s an HBO film, after all).

Bioethics Commission Looking Retrospectively In Next Meeting

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.

NIH, Wellcome and Howard Hughes Want Your Open Science Proposals

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.

Is CRISPR Dual-Use Research Of Concern?

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.

Public Sessions Announced For Input On Revising Biotechnology Product Regulations

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.