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.

FTC Takes Aim At “Brain Training”

On Tuesday the Federal Trade Commission announced a settlement with Lumos Labs, the company behind the Luminosity ‘brain training’ subscription program (H/T ScienceInsider).  The company will pay $2 million to its subscribers in connection with its claims that the products would help prevent cognitive decline, reduce cognitive impairment and improve cognitive functioning.  The FTC alleged in its complaint that the company failed to back up its claims and that it failed to disclose that some of the testimonials the company used were solicited with prizes.

The proposed order would require the company to have competent and reliable scientific evidence at hand when making the kinds of claims it did.  Additionally, the company must notify its subscribers that participate in auto-enrollment and allow them means to cancel their subscriptions.

Meanwhile, if you see any advertisements for Luminosity or similar programs, I’d encourage you to ask for evidence behind any claims.

Scientists Under Investigation In Italian Xylella Outbreak

Scientific American has reported that a formal investigation is underway concerning nine scientists and one public official concerning an outbreak of Xylella fastidiosa in and around Puglia, Italy.  The outbreak (first noted in 2013) has affected olive trees in the area, and efforts to contain the outbreak have prompted both protests from activists and investigation from the European Union.

The case involving Italian seismologists and the L’Aquila earthquake of 2009 was long and complicated, so I already expected that the investigation into these scientists – suspected of introducing and/or allowing the spread of the Xylella strain – would be a challenge to follow.  Now that the EU is involved, I think a long, complicated legal case is assured.

The scientists are under suspicion for introducing the strain because of a 2010 training course where a strain of Xylella was used.  That claim is being refuted because the strain considered the cause of the outbreak is distinct from the Californian variety used at the course.

Some of the criticism is prompted in part due to the measures the scientists are calling for in order to combat the strain.  Several parties object to the destruction of trees (many of them quite old) and the use of pesticides in the area.  The prosecutors in the case have called for a halt to such measures when they announced the formal investigation.  Aside from placing the scientists under suspicion of causing the outbreak (either intentionally or through neglect), it has been contended that the actual cause of the outbreak is not the Xylella, but a fungus.

The European Union is involved because of concerns over the possible spread of the pathogen to other countries.  As part of EU rules, Italy is obligated to develop and implement a containment plan.  However, some of the measures have been blocked by the courts, and it is possible that the contentions against the scientists are another means of fighting against the EU rules.

I am concerned that the length of any Italian court proceeding may make it difficult to effectively address the outbreak.  With the final appeals of the L’Aquila case stretching things out to at least six years following the 2009 quake, there may be at least another three years before the Italian courts adjudicate the matter (regardless of how the EU enforcement and judicial mechanisms may act).  Perhaps the outbreak can be contained in time, but it’s tough to see this case as helping.

The FDA Insists On Egg In Your Mayonnaise, But Not In Your Mayo

Just Mayo is a vegan mayonnaise substitute produced by Hampton Creek.  I’ve had it, and it persuaded my pedestrian palate that it tastes like mayonnaise (something comparable substitutes have not).  The product does not contain any eggs, so it can’t be labeled as mayonnaise, at least in the United States.

As defined in the Code of Federal Regulations Section 169.140, mayonnaise must include egg-yolk containing ingredients including:

“Liquid egg yolks, frozen egg yolks, dried egg yolks, liquid whole eggs, frozen whole eggs, dried whole eggs, or any one or more of the foregoing ingredients listed in this paragraph with liquid egg white or frozen egg white.”

As Just Mayo doesn’t contain eggs, there was disagreement as to whether or not the product could include Mayo in its name.  Quartz has a recap of the events, but one company sued Hampton Creek for false advertising (the suit was withdrawn), and the American Egg Board (whose members are appointed by the Agriculture Secretary) also acted against the company, and Board documents showed it was seriously worked up over the success of Just Mayo.

This attention eventually prompted a letter from the Food and Drug Administration to Hampton Creek in August warning the company that it could not use mayo in its product name if the product wasn’t legally mayonnaise.  (There were additional health claims questioned by the FDA in the letter.)

Hampton Creek has been in discussion with the FDA on the matter, and will make changes to its label that the FDA considers satisfactory.  A closeout letter from the agency is anticipated.

The insistence on using eggs to legally be mayonnaise in the U.S. might remind readers of the fact that tomatoes, while botanically fruits, are vegetables in the U.S. for purposes of a tariff.  In that case, the rationale from the court focused on how tomatoes are considered in ‘everyday life’ compared to their botanical nature.

That rationale could be applied to mayonnaise, with the everyday conception of mayonnaise as including eggs.  The apparent accommodation from the FDA appears to stake out a middle ground.  The product will still be called Just Mayo, but the new labels will call it a spread and dressing.  The forthcoming closeout letter might address this hair-splitting, as it might prompt other mayonnaise substitutes to move toward this middle ground.

Deadline Extended For Comments On Human Subjects Protection Regulations

The agencies working to update federal regulations on human subjects protection (colloquially known as the Common Rule) have extended the deadline for public comments.  Originally set for next Sunday, December 6, it has been extended to January 6, 2016.

(I know in my original post I had made noises about making more detailed comments on the request for comments.  I will do my best to make the original December 6 deadline.)

The extension has been made in part due to requests received from the public for additional time to comment.  Given that the comment period for the Advanced Notice of Proposed Rulemaking released in 2011 was also extended one month, this extension is not surprising.

It would be nice if the Administration would get off of its annoying trend of very short – often 90 days or less – to comment on significant policy documents like the proposed changes to the Common Rule.  Dumping these notices at the beginning of weekends or holiday periods (this was published the day before Thanksgiving) is also annoying, and undercuts any intentions on being really open and transparent with goings-on.

 

Homeopathy May Receive Heightened Scrutiny From Regulatory Agencies

While it appears (at least to me) to get more attention (and ridicule).  Homeopathy – the attempt to treat conditions with items that produce the same symptoms in healthy patients – is a business of note in the U.S.  While the Food and Drug Administration (FDA) regulates homeopathic treatments, it does not make claims as to their efficacy.

(Let’s put aside the discussion of what reason there might be to regulate a substance without judging whether it does what it is claimed to do.)

That might change soon.  According to Dan Vergano at Buzzfeed, both the FDA and the Federal Trade Commission (FTC) may act soon on homeopathic treatments.  The FTC has raised concerns that FDA practice in this area runs counter to the FTC requirement that health claims in advertising need to be backed up by “competent and reliable scientific evidence.”

This has, apparently, been a longstanding conflict, as the FDA first promised to put homeopathic products up to a standard comparable to the FTC’s in 1972.  Maybe, just maybe, this long standoff is approaching an end.