Friday, May 20, 2016

FDA Finalizes Food Facts

On May 20, 2016, the United States ("U.S.") Food and Drug Administration ("FDA") released the final version of the revised food and drink labels legally-required to accompany most food and drink sold in the U.S..  Here is an example of a new label:
The differences between the old and new food labels are subtle, but not trivial.  Among the changes are requirements that sellers use more realistic serving sizes reflective of how much a typical person would actually eat at one sitting.  For example, the old regime allowed preposterous serving sizes such as three lonely potato chips!  The new label must list much larger amounts.  In addition, a new subcategory of carbohydrates must list the amount of sugars added to a serving of food or drink above and beyond those sugars found in the preprocessed version of that food or drink.

Although food and drink labels are often ignored by consumers, they do provide a valuable source of nutritional information for any who care to read them.  This information can be crucial to people on special diets or with conditions such as diabetes.  The FDA could have opted for a more revolutionary approach to revamping label design, but, instead, the agency appears to have decided on a gradual, evolutionary approach to improvement.  At least the latest changes might reduce the impression that anyone who eats more than three potato chips at one sitting - a nearly-universal trait - is a shameless glutton.

Thursday, May 19, 2016

National Academies On GE Crops

The influential United States National Academies ("NAs") released their latest assessment of the environmental and health risks of genetically-engineered ("GE") crops on May 17, 2016.  Despite widespread, and often inchoate, anxiety among the public, GM crops have rapidly displaced non-GE crops around the world.  So, are they safe?

The NAs' report, entitled Genetically Engineered Crops:  Experiences and Prospects, provides a comprehensive review of existing scientific evidence.  Although they hedge their answers, as befits the complexity of published studies, the NAs conclude that evidence for negative consequences of GE crops is generally lacking.  They suggest that the economic effects lean to the positive side of the cost/benefit ledger:
The available evidence indicates that GE soybean, cotton, and maize have generally had favorable economic outcomes for producers who have adopted these crops, but outcomes have varied depending on pest abundance, farming practices, and agricultural infrastructure. Although GE crops have provided economic benefits to many small-scale farmers in the early years of adoption, enduring and widespread gains will depend on such farmers receiving institutional support, such as access to credit, affordable inputs such as fertilizer, extension services, and access to profitable local and global markets for the crops.

The NAs concluded that neither humans nor animals appear to have been harmed by consuming food derived from GE crops:
The committee carefully searched all available research studies for persuasive evidence of adverse health effects directly attributable to consumption of foods derived from GE crops but found none. Studies with animals and research on the chemical composition of GE foods currently on the market reveal no differences that would implicate a higher risk to human health and safety than from eating their non-GE counterparts. Though long-term epidemiological studies have not directly addressed GE food consumption, available epidemiological data do not show associations between any disease or chronic conditions and the consumption of GE foods.
And, the NAs found little evidence that GE crops harm the environment:
The use of insect-resistant or herbicide-resistant crops did not reduce the overall diversity of plant and insect life on farms, and sometimes insect-resistant crops resulted in increased insect diversity, the report says. While gene flow – the transfer of genes from a GE crop to a wild relative species – has occurred, no examples have demonstrated an adverse environmental effect from this transfer. Overall, the committee found no conclusive evidence of cause-and-effect relationships between GE crops and environmental problems. However, the complex nature of assessing long-term environmental changes often made it difficult to reach definitive conclusions.

Nevertheless, the NAs do warn that biotechnology is a dynamic and evolving set of techniques, and suggest ongoing regulatory oversight:
Emerging genetic technologies have blurred the distinction between genetic engineering and conventional plant breeding to the point where regulatory systems based on process are technically difficult to defend. The committee recommends that new varieties—whether genetically engineered or conventionally bred—be subjected to safety testing if they have novel intended or unintended characteristics with potential hazards.
  This report will not be the final word on GE crops.  In fact, the popularity among consumers of food they perceive as "non-GE" represents a substantial, continuing challenge to GE crops, with increasing demands by the public and national regulators that GE and non-GE crops be carefully sequestered from one another to avoid cross-contamination.  Time will tell whether or not scientific assessments such as the NAs' will change public opinion.  In the meantime, both supporters and opponents of GE crops have the benefit of this new and authoritative source of evidence and analysis from the NAs.

Monday, May 2, 2016

Closing The (Google) Books On Fair Use

The United States Supreme Court wrote the final chapter on Authors Guild v. Google, Inc.. on April 18, 2016, simply ordering that
[t]he petition for a writ of certiorari is denied. Justice Kagan took no part in the consideration or decision of this petition.
Lexvivo previously covered the Google Books case on October 16, 2015, in Book 'Em Google!.  Perhaps now we can all turn the page on this type of fair use.

However, never fear, intellectual property aficionados, for, on May 2, 2016, the Supremes also issued the following two orders:
15-866  STAR ATHLETICA, L.L.C. V. VARSITY BRANDS, INC., ET AL. The petition for a writ of certiorari is granted limited to Question 1 presented by the petition. 
15-927  SCA HYGIENE PRODUCTS V. FIRST QUALITY BABY PRODUCTS The petition for a writ of certiorari is granted.
The former involves a copyright case probing the contours of functionality in copyright.  The latter is a patent case on whether laches is available as a defense to infringement within the statutory six-year window for recovering damages authorized by 35 U.S.C. §286 (Time limitation on damages).

So, there will be much more intellectual property fun to come.

Thursday, February 4, 2016

Aukward Law

The Long Now Foundation posted a story on February 4, 2016, describing a wonderful meeting I had the honour of participating in last summer at the International Centre for Life in Newcastle, U.K..  The meeting was organized and hosted by peerless peer and gifted author (most recently of The Evolution of Everything - How Ideas Emerge), Matt Ridley.  Key inspirations were champions of deextinction Stewart Brand and Ryan Phelan, along with Ben Novak, lead researcher for the Long Now Foundation's Revive & Restore Passenger Pigeon (Ectopistes migratorius) project.  Together with an expert group of genomicists, geneticists, developmental biologists, ecologists, and others, we explored how the Great Auk (Pinguinis impennis) might be brought back from extinction.  I contributed a legal and policy framework for reviving and reintroducing the Great Auk from oblivion.

The Great Auk is extinct.  Long live the Great Auk!

Tuesday, February 2, 2016

Human CRISPR Becomes Clearer

The agency responsible for regulating reproductive biology in the United Kingdom ("U.K."), the Human Fertilisation and Embryology Authority ("HFEA"), has made the U.K. the first democracy to approve the application of CRISPR/Cas9 to human embryos.  (Similar experiments took place in China in 2015, causing a firestorm of controversy.)  Here is its February 1, 2016, announcement:
Our Licence Committee has approved an application from Dr Kathy Niakan of the Francis Crick Institute to renew her laboratory’s research licence to include gene editing of embryos. 
The committee has added a condition to the licence that no research using gene editing may take place until the research has received research ethics approval. 
As with all embryos used in research, it is illegal to transfer them to a woman for treatment.
This is a momentous step in CRISPR/Cas9 research, and one that is sure to create tremendous pressure for similar regulatory approvals among other democracies fearing they might fall behind in this revolutionary biotechnology.  Le déluge vient.

Sunday, January 24, 2016

Gilbergstrom and Sullivan

With his permission, I would like to post the lyrics of my brilliant friend Carl Bergstrom's wonderful new song "Modern Research Parasite".  Built on a rhythmic scaffold provided by Gilbert and Sullivan's "Major-General's Song" from The Pirates of Penzance, enjoy Carl's masterpiece. Here it is:
I am the very model of a modern research parasite,
I build on other research leaving only here-and-there a cite.
I know the Nobel laureates and quote the fights cladistical,
From Felsenstein to Farris using language most statistical. 
I can passage flu in ferrets to endanger all humanity,
And argue open access until Harnad sounds like Hannity.
I know our mythic history, from Galen to Chetverikov,
And advocate the medicines you cannot get generic of. 
I’ve memorized the sequence of each ENCODE base of DNA,
And I can tell at sight Feng Zhang from Doudna and Charpentier.
But still I need your data like anemics need their ferrocite.
I am the very model of a modern research parasite.
For more context, check out Carl's Twitterstream:  @CT_Bergstrom.  I hope Carl gets the band back together so he can post his live rendition on YouTube.

Wednesday, January 20, 2016

Trademark Parking

Private trademarks involving public parks might seem an odd juxtaposition.  However, this phenomenon may not be as rare as one might suppose.  For instance, Donald J. Trump has apparently registered federal trademark rights in "Central Park".  Now a trademark dispute has erupted over the names of several famous hotels located inside Yosemite National Park.  As a consequence, these iconic hotels may soon have new monikers.  For example, the Ahwahnee Hotel may transform into the much more prosaic "Majestic Yosemite Hotel".  What's next?  Perhaps Yosemite itself could be renamed "A Few Hours East of San Francisco National Park"?  Changing such famous names is bound to cause controversy, as NPR discussed on January 19, 2016.

Detaching trademarks from these famous hotels would certainly cause consumer confusion, not to mention consumer disillusionment.  On the other hand, since a new company would be managing the hotels, there could also be consumer confusion as to the source of hotel management if the names were to remain the same.  Negotiations are most likely proceeding between the departing manager of the hotels, Delaware North, and incoming managers, Aramark, because, with the hotels detached from their trademarked names, the value of the trademarks to anyone is likely to decay rapidly.

Tuesday, January 19, 2016


The leading scientific journal Nature has reported possible shenanigans in research on the genetically-modified organisms ("GMOs") at the University of Naples.  As the article relates,
Papers that describe harmful effects to animals fed genetically modified (GM) crops are under scrutiny for alleged data manipulation. The leaked findings of an ongoing investigation at the University of Naples in Italy suggest that images in the papers may have been intentionally altered. The leader of the lab that carried out the work there says that there is no substance to this claim.
Peer reviewed biological research finding adverse health effects from GMOs is elusive.  Nature points out that
The papers’ findings run counter to those of numerous safety tests carried out by food and drug agencies around the world, which indicate that there are no dangers associated with eating GM food.
This research, and the allegations of misconduct it has spawned, should provide much food for thought among both opponents and proponents of food biotechnology.  Bon appétit!

Monday, January 18, 2016

Star Wars: A New Hip

I finally saw the Star Wars Episode VII. Here is my review.

The Force Awakens is a fine workmanlike film. If it were the final project of a student, it would earn a B+. This is a good grade, really, though one that leaves ample room for improvement. Frankly, I, like many people, was relieved that it was not bad. Here is my new hope: the series will wipe the sleep out of its eyes, stretch, get out of bed, and go about its day without a yawn.

The two major themes of the Star Wars series appear to be (1) kids rebel against their parents and (2) bad guys are obsessed with death stars. The first of these is certainly universal, and, to be sure, the far more frightening of the two. Just ask any parent. The second must now have reached its physical limit. Having struck out three times, the dark force forces should really rethink how best to impose evil on the entire cosmos. Death stars are not the way. Things are now so bad for the bad that perhaps they should resort to the last of last resorts: management consultants. Surely McKinsey & Company could offer some innovative new approaches to managing evil change. How about more relatable names for Sith, such as Freddy, Diane, George, or Simone, or even new colors for lightsabers, like pink, pinstripe, paisley, or rainbow?  Rock stars, throwing stars, or even star fruit would be far preferable to Star Wars' apparent death stare decisis.

Now, what about casting?  It was fun to see prominent crossovers and veteran actors. One wonders if Kylo Ren will soon be joined by his partner Kylo Stimpy. What a brave decision to cast a Teletubby, Po, as the leading rebel pilot, when Tinky Winky would obviously have been a far safer choice! Including Han, Leia, Luke, and Chewbacca was a poignant reminder of the perils of an inadequate retirement insurance system. Finally, The Force Awakens provided a reminder of how universal British accents are throughout the universe, whether for baddies or goodies, though I question the quixotic decision that allowed actress Daisy Ridley to speak in her plummy native Westminster accent while fellow Brit John Boyega had to exchange the dulcet tones of his British accent for a less mellifluous Yankee drawl.

May the Force fully awaken in the next installment!