Pursuing Nature to Her Hiding Places

“Tomatoes May Be Dangerous to Your Health” was the headline of an opinion piece published on June 1, 1992 by the New York Times.  In it, Sheldon Krimsky criticized the exemption of genetically engineered crops from certain levels of review by the Food and Drug Administration (“FDA”).    He was referring to the Flavr Savr’ Tomato, the first genetically engineered food later to be granted a license for human consumption by the FDA.  That species of tomato included engineered genes that were to slow the natural softening process that accompanies ripening.  The idea was that the tomatoes could spend more time on the vine than other tomato species, producing more flavor, but still remaining firm enough to ship. 

In response to Krimsky’s article, Paul Lewis wrote a Letter to the Editor in which he coined the term Frankenfood to refer to food derived from genetically engineered crops: 

Ever since Mary Shelley’s baron rolled his improved human out of the lab, scientists have been bringing just such good things to life.  If they want to sell us Frankenfood, perhaps it’s time to gather the villagers, light some torches and head to the castle. 

The term caught on and many still continue to use it in referring to food produced from genetically engineered crops. 

The reality is that humanity has been engaging in a form of genetic manipulation of crops even since the earliest days of agriculture, but such processes were a result of selective breeding rather than through direct manipulation of genes.  Consider the case of milk production, for example.  As a result of identifying bulls who have highly desirable genes, the number of bulls that are used to sire dairy cows is astonishingly small, resulting in a very narrow range of genetic diversity among cattle in the dairy industry.  At the time of his death in 1997, for example, the Dutch Holstein Friesian bull named Sunny Boy had sired some two million calves.  The impact on the genetic origin of dairy products throughout the world was a direct result of human intervention in natural processes.  Or consider the production of soybeans.  In the 1990’s, the entire soybean crop in the United States — some 60 million tons — was descended from a mere dozen soybean strains that had been collected in northeastern China.  

Since the FDA approved human consumption of the Flavr Savr’ Tomato in 1994, there has been a huge infiltration of genetically modified crops into the food supply, especially in the United States where more than 90% of the soybean, cotton, and canola markets are supplied by genetically modified crops.  Byproducts of those crops — notably soy lecithin — are found in thousands of processed-food products:  chocolate bars, baby foods, margarine, breakfast cereals, and many others. 

This week, the FDA is conducting hearings as part of its consideration whether to allow human consumption of AquAdvantage, a genetically modified species of Atlantic salmon that some are — inevitably — calling a frankenfish.  The application was submitted to the FDA in 1995, but the agency has so far never approved any genetically modified animal for human consumption.  AquAdvantage has been modified so that it grows twice as fast as its natural counterpart.  Critics have expressed two concerns:  that the effect on people who consume the fish is unknown and that if the genetically engineered fish escapes, it may have a negative impact on the natural salmon population.  These concerns are not frivolous ones:  salmon populations are already depleted because of overfishing, and if the genetically modified fish grows at twice the speed as naturally occurring salmon, there is a possibility of disrupting the food supply for natural salmon populations. 

It can be difficult to predict all of the effects of genetic modification of organisms.  For example, there is a known history of genetically modified plants producing substances they hadn’t produced before or of repressing the production of substances they normally produce:  transgenic potatoes that were supposed to make more starch and less sugar did the opposite; transgenic tomatoes that were made to produce excess carotene became unexpectedly smaller; and perhaps most notably, reproduction mechanisms of some plants changed so that inserted genes unexpectedly started appearing in other plant species. 

Surveys confirm that there is generally a strong desire by people in the United States to have food labeled as arising from genetically modified organisms, something that the FDA has never required.  Industry interests in the United States generally oppose labeling — jurisdictions elsewhere in the world where labeling is required, notably the European Union and Japan, find almost no one willing to buy food derived from genetically modified organisms. 

The FDA has taken the position, however, that federal law, when properly construed, actually prohibits the agency from requiring labeling of food derived from genetically modified plants.  The relevant law that the FDA cites is found in the Food, Drug, and Cosmetic Act (21 U.S.C. §343) and prohibits a variety of food labeling that is “false” or “misleading.”  The FDA has concluded that because it has generally found food derived from genetically modified sources not to be “materially different” than food derived from natural sources, it cannot require labeling, and this position has been upheld in court:  Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d 166 (D.D.C. 2000).  Producers of genetically modified food are permitted to add labels if they wish, but none do. 

It seems likely that AquAdvantage will be approved for human consumption in due course.  One of the objectives of the hearings is to determine whether the FDA’s position on labeling should be different because this is an animal to be consumed rather than a plant.  Some background material on the labeling issue prepared by the FDA can be read here

It was only three years after the release of the Flavr Savr’ Tomato that its producer Calgene needed to withdraw it from the market.  They were sold under the brand name MacGregor’s in California and a few places in the Midwest of the United States.  But they turned out to be more delicate than expected, bruising easily so that special trucks were needed for transportation.  Delivery of the tomatoes to grocery stores became prohibitively expensive.  Perhaps AquAdvantage will be no more successful in the end.  But whether it is approved soon by the FDA or not, it is clear that consumption of such animals is a genie that will soon be out of the bottle and very unwilling to get back in.

Grousing About Politics and Science

When the United States and France completed the Louisiana Purchase in 1803, it was unclear exactly how much land was being exchanged.  President Thomas Jefferson accordingly commissioned the Corps of Discovery to explore the territory, choosing his friend Meriwether Lewis to lead the expedition.  Over a period of some two and half years, Lewis and his partner William Clark were to conduct the first overland expedition of North America to the Pacific coast and back. 

During their travels, they established relationships with some of the native peoples, notably eliciting the aide of the Shoshone woman Sacagawea to act as a guide and interpreter.  They were to provide a significantly improved understanding of the geography of the northwestern United States and to document 122 previously unknown species of animals and 178 new plants and trees. 

It was at the mouth of the Marias River in what is now Chouteau County, Montana that Lewis and Clark encountered the sage grouse on June 6, 1805.  Their native-american companions told them it was a common bird, and indeed their journals record further encounters throughout much of the region.  Estimates are that sage grouse numbered somewhere around 16 million in population around the time of their documentation by Lewis and Clark.  Today, it has only a fraction of that population — somewhere about 250,000 — and efforts to include it on the Endangered Species List have become emblematic of what many scientists see as political encroachment on scientific independence. 

Earlier this year, Secretary of the Interior Ken Salazar announced that the sage grouse “warrants” inclusion on the List but that it was “precluded by the need to address higher priority species first.”  A very different decision was made under the Bush administration in 2005 when Deputy Assistant Secretary Julie MacDonald ruled against its listing.  That decision was one that highlighted some of the most egregious interference with science for political reasons in recent memory.  In Western Watersheds Project v. United States Forest Service, the Idaho District Court described the conduct of the Deputy Assistant Secretary as “inexcusable,” finding that “[h]er tactics included everything from editing scientific conclusions to intimidating [Freedom and Wildlife Service] staffers.”  The court’s ruling, which can be found here, documents repeated and persistent “attempts to improperly alter the ‘best science’ findings” as part of a campaign to achieve “preordained” political objectives.  Similar allegations have been leveled against her by scientists in numerous other cases involving decisions not to list certain species. 

It is perhaps no surprise then that the release of a draft policy on scientific integrity by the Interior Department is being viewed with considerable skepticism by scientists.  Those scientists remember well when President Obama issued his Memorandum on Scientific Integrity on March 9, 2009 calling for the development of “recommendations for Presidential action designed to guarantee scientific integrity throughout the executive branch” within 120 days.  A copy of his Memorandum can be found here.  It was still the honeymoon period for the new administration and at the time, the apparent commitment was heralded by many scientists as a welcome change from perceived attempts by the prior administration to suppress scientific knowledge and conclusions for political purposes.  But that enthusiasm has steadily given way to frustration and disappointment as time still continues to pass more than a year after the President’s deadline without any recommendations or plan being developed. 

The release of the Interior Department’s draft policy a couple of weeks ago is the first real manifestation of the executive branch’s implementation of policy directed to scientific integrity.  Most scientists who have read it believe it falls short.  Of particular concern is language that appears still to allow political appointees to alter scientific documents, exactly what was happening in considering additions to the Endangered Species List by the prior administration:  “During the conduct of Departmental business, decision makers may be involved in editing of documents for clarification of major points to aid decision making.”  But more broadly, the policy is seen as having insufficient provisions for preventing other types of political interference in science.  Another provision, for example, warns that “[p]ublic release of a scientific product without the required level of review or without appropriate disclaimers could be considered misconduct.”  There is concern that the normal circulation of material by scientists among their peers for scientific evaluation could be considered misconduct, particularly since little guidance is given by the policy as to when dissemination is “premature.” 

A copy of the draft policy can be read here

To be fair, the policy has been released in draft form as part of the normal rule-making procedure that is followed by Executive agencies so that comments can be collected from the public and considered prior to its actual implementation; the comment period is set to expire on September 20, 2010.  That procedure is an important part of the process, allowing the public at large to identify and articulate deficiencies in proposed policies or rules.  Proposals can sometimes be modified significantly in light of the comments that are provided, and the hope is that that will happen in this instance.  But even if the major concerns are addressed, scientists will still eagerly await the more broadly applicable recommendations promised by the President in the ambitious early days of his tenure.

Chickens and Eggs

When I was in law school, there was a contracts case that everyone loved:  Frigaliment Importing Co. v. B.N.S. International Sales Corp.  They loved it because the judge who wrote the opinion spelled out in the first sentence of the opinion what the issue was:  “The issue is, what is chicken?” 

It seems that not all chicken is the same.  Young chickens are suitable for broiling and frying while older, heavier chickens are only suitable for stewing.  When the supplier delivered the older, less desirable chickens pursuant to a contract, a dispute was launched in which the parties argued whether “chicken” referred to any animal of that species or whether it referred more narrowly to the more desirable young chickens.  This 50-year-old decision can be read here.   

As pollsters have known forever, and as law students quickly learn on the path to becoming attorneys, the ability to frame an issue is very often decisive.  It puts the person who needs to make a decision in the “right” frame of mind so that he is much more naturally led to the decision that is desired.  Mr. Clinton famously attempted this tactic when he was facing impeachment as President.  When asked about the truthfulness of his statement with respect to his relationship with Ms Lewinsky that “there’s nothing going on between us,” he very calmly explained to the grand jury that “[i]t depends on what the meaning of the word ‘is’ is.” 

Well, of course.  That cleared things up very nicely. 

Whether one supported Mr. Clinton or not, the audacity of his statement was striking.  But it also happens to have been correct.  The interpretation of his statement did, in a literally strict way, depend on what the full semantic meaning of “is” is.  Still, it was a lawyer’s answer. 

Last week, the fate of federal funding of an important avenue of scientific investigation hinged on a similarly couched issue:  What is “research”? 

The Dickey-Wicker Amendment is a rider that has been attached to each of the Labor, Health and Human Services, and Education appropriations acts every year since 1995.  It has been enacted by both Democratic-controlled and Republican-controlled legislatures, together with the signature of Clinton, Bush, or Obama, depending on the specific year of enactment.  Its wording has been approximately the same each year: 

“None of the funds made available in this Act may be used for … (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero ….” 

Embryonic stem-cell research has received a great deal of attention in recent years because of the pluripotency of the cells — they have the ability to be guided into growth of any type of cell that exists in the human body.  The list of diseases that could potentially be treated with such versatility is long, although research is still in its very early stages:  the first human clinical trials using stem cells were approved only in 2009 by the Food and Drug Administration for treatment of individuals suffering from spinal-cord injuries. 

Although suggestions were published in 2006 of a method of extracting stem cells from embryos without destruction of the embryo, almost all embryonic stem-cell research has required the use of stem cells derived from destroyed embryos. 

And this is where the interpretation of the word “research” in the Dickey-Wicker Amendment becomes relevant.  In 1999, the National Institutes of Health determined that embryonic stem-cell research was exempt from the Amendment because the stem cells are not themselves embryos and “research” on the stem cells, isolated from the process of deriving them, does not result in the destruction of embryos.  Mr. Bush, in an attempted Solomonic decision issued in 2001 when he was President, appeared to accept this basic interpretation:  He permitted stem-cell research to continue on lines that already existed at the time of his statement because the embryos had already been destroyed but prohibited the development of new lines that would require the destruction of embryos. 

Last week’s decision by the federal District Court for the District of Columbia rejected even the Bush compromise.  The court refused to parse the individual acts of “research” separately.  Instead, the Court determined that “the language of the statute reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed.  This prohibition encompasses all ‘research in which’ an embryo is destroyed, not just the ‘piece of research’ in which the embryo is destroyed.”  Accordingly, a Preliminary Injuction was issued prohibiting the use of federal funds to support embryonic stem-cell investigations.  The full opinion can be read here.  

Is the court correct?  As much as I personally support investigations into the use of embryonic stem cells because of their tremendous potential in the treatment of disease, I have difficulty faulting the Court’s decision.  Mr. Clinton’s attempt to parse the semantics of “is” with extreme fineness fails what attorneys frequently refer to as the “blush test” — it may be technically correct, but if the argument cannot be made without getting red in the face, its technical nature goes beyond reasonable limits.  In Frigaliment half a century ago, the court concluded that “chicken” was properly construed by the broader term and not in the narrower way that the buyer had conveniently attempted.  And to construe “research in which a human embryo or embryos are destroyed” as not including investigations on cells that are obtained through destruction of embryos seems more to be a similarly convenient contrivance than it is giving true effect to words of the statute. 

But I feel it is worth providing some final comments about stem-cell research.  It may well be that current law prohibits federal funding of such research, but such laws may be changed by Congress.  And they need to be changed.  As things stand, there is no prohibition on the creation of embryos that are never to mature into full human beings.  Indeed, excess production of embryos during in vitro fertilization is part of a technique that has allowed countless women to have children that they would never have been able to produce without such techniques, bringing joy and a sense of personal fulfilment to their lives.  The number of frozen embryos in cryogenic facilities around the United States is estimated to be approaching 1,000,000.  It is unrealistic to prohibit the destruction of those excess embryos and, indeed, there is no blanket legal prohibition on their destruction.  Instead, the only prohibition that now exists is in allowing the destruction that is going to take place anyways to aid research that holds near-miraculous promise for treating untold numbers of suffering individuals. 

To me, it is the purposelessness of that kind of destruction that is the real affront to human dignity.

Who Sows Wind Will Harvest Storm

Wind Energy.  It’s great for the environment, right?  No greenhouse-gas emissions.  No radioactive waste to dispose of.  Completely renewable so there’s never any risk at all of exhausting its supply.

Even in this era of seemingly endless acrimony among the political parties of the United States, there is actually strong agreement that wind energy is a good thing, for all of the reasons cited above and many others.  In a survey conducted by the American Wind Energy Association in April, 84% of Republicans, 93% of Democrats, and 88% of Independents expressed their belief that increasing the amount of energy the U.S. produces from wind is a good idea.  That kind of agreement is just unheard of these days.

So why have environmental groups taken to filing lawsuits to block the development of wind farms?  That’s what they want, isn’t it?  To promote the use of “green” forms of energy production?  Are they just a bunch of tree huggers who look for an excuse to oppose everything just because they like to be contrary?  Or do they have a point?

The environmental concerns about wind farms arise because the motion of the turbines results in the death of many flying animals, notably birds and bats.  Most of the deaths occur because of collisions with the turbines, but they can also occur from a condition known as barotrauma.  In the same way that human divers can develop the bends when they decompress by returning to the surface from sea depths too quickly, barotrauma occurs when the motion of turbine blades at wind farms create low-pressure zones that can cause the lungs of small animals to hemorrhage.

A legal basis for challenging the development of wind farms from an environmental standpoint arises particularly when the affected animals have a protected status under the Endangered Species Act.  The first such case was Animal Welfare Institute v. Beech Ridge Energy LLC, which concerned the Beech Ridge Wind Energy Project along the Appalachian mountain ridgelines in West Virginia.  The project was budgeted at some $300 million and expected to produce 186 megawatts of power, enough to satisfy the energy needs of 50,000 households in a typical year.

But the site was in the migratory path of the tiny Indiana bat, a species of bat that weighs only a quarter of an ounce.  The Indiana bat has been designated as an endangered species since 1967, and its population has since that time reduced by about 50% despite that designation.

The court, in an order issued December 8, 2009, allowed the completion of 40 turbines whose construction had already begun, but ordered that those turbines could only be operated during the hibernation phase of the Indiana bat, a period of about three and a half months from November to March each year.  If the turbines are to be operated at other times of the year, a permit is required from the Fish and Wildlife Service after it conducts a study on the impact of the wind farm on the bats.  The process for obtaining a permit is currently ongoing; the Fish and Wildlife Service issued a Request for Information last week as one of the first steps in its investigation.

Subsequent to the decision, a settlement was reached between the parties that allows for construction of an additional 27 turbines, provided they are only operated at times of the day and year when Indiana bats are not expected to be flying.

In many ways, this result seems harsh.  There are many calls to develop alternative forms of energy production and wind energy is an important one of these.  And the operation of a large project that would supply energy for tens of thousands of households has been constrained to accommodate the schedule of a tiny animal that is rarely observed.

But this was just the first of what appears to be quickly turning out to be a large number of lawsuits challenging wind farms because of their impact on endangered species.  Last month, a lawsuit was filed to stop the Cape Wind Project, an offshore wind farm planned in Nantucket Sound off Cape Cod in Massachusetts.  This would be the nation’s first offshore wind farm, but the lawsuit alleges that it would endanger piping plovers, a protected species of bird, as well as endanger whales.  Threats have been made to bring a lawsuit to stop the Garrett County wind project in western Maryland because of its impact on both the Indiana bat and the Virginia big-eared bat, another protected species.  The Radar Ridge Wind Project in the State of Washington may be in jeopardy because of concerns about the migration patterns of the protected marbled murrelet.  Wind projects in California are coming under increasing scrutiny because of deaths of whooping cranes at wind farms, one of the first birds to be listed as endangered under the Endangered Species Act.  And there are many other examples gaining attention in the wake of the Beech Ridge decision.

There are other legal concerns related to wind farms and which have resulted in lawsuits, this time because of their impact on human beings.  Noise from turbine motion is a common source of the complaints that lead to lawsuits.  But even more interesting is turbine shadow flicker, an effect caused by the rotation of the turbines that produces a strobe effect when sunlight shines along a path that includes the turbines.  Shadow flicker can cause eyestrain, headaches, nausea, and even induce epileptic seizures in some people.

But I will leave the discussion of this aspect of wind-energy lawsuits for another day.

The Missing Link

Eoanthropus dawsoni.

This is one of the most famous hominids ever discovered. But certainly for the wrong reasons.

It was 1912. Very few hominid fossils had so far been found. Neanderthal Man in 1856; Cro Magnon Man in 1869; Java Man in 1890; Peking Man in 1903; Heidelberg Man in 1908. Each of these discoveries had added a small piece to the great puzzle of modern man’s origins, but there was still no clear species that represented a clear link in the evolution between ape and man.

In a way, that changed with the 1912 discovery of the fossil remains of a hominid — identified as eoanthropus dawsoni after the man who discovered them — that clearly showed a mix of features between ape and man. Found in quarries in Sussex, England, the skull was similar to that of modern man, but would hold only a brain about two-thirds the size of a modern brain. And the jawbone was decidedly more apelike. The combination supported the theory that the evolution between ape and man would begin with the brain so that the skull would evolve before the jaw into a form closer to what exists today.

There were skeptics, mostly among French and American paleontologists. But there were also those who saw the discovery as a critically important one, particularly British paleontologists in a pique of nationalist pride. But as time went on and further hominid fossils were discovered, it became increasingly difficult to fit eoanthropus dawsoni into the developing framework of human evolution. Experts perhaps puzzled over it at times, recognizing it as anomalous.

It would be forty years before the discovery of the fossils — made in the quarries of Piltdown — would be discovered to be a fraud. It was an elaborate hoax perpetuated by someone whose identity remains a mystery today, even though there are various theories about who it might have been. Certainly the fossils had been carefully prepared to make them look far older than they actually were, and it was with the use of much more modern dating techniques that the fraud was ultimately exposed. The preparations clearly required knowledge about the techniques that paleontologists would use in analyzing the fossils, making the hoax seem elaborate and almost sinister.

The four-decade episode of Piltdown Man is an instructive one, exposing the limits that may exist with scientific analyses and the ability of some to exploit those limits to mislead.

The more recent episode of “Climategate” is an attempt to suggest that a similar hoax is being perpetuated by some climate scientists today. The episode began in November of last year when a variety of emails and documents were hacked from the University of East Anglia’s Climatic Research Unit computers. Through a rather selective citation of isolated phrases out of context from stolen documents, a scandal was orchestrated, accusing the scientists who were quoted of colluding in a campaign to withhold scientific information, to manipulate data, and to interfere with the peer-review process in order to perpetuate a hoax of increasing global temperatures.

One particular focus of the allegations has been language in an internal email related to the famous “hockey stick” graph that shows sharply increasing global temperatures in modern times. It is a private email written between two scientists and needs to be understood in that context. It undoubtedly refers to a “trick” used to “hide the decline.” But scientists use the word “trick” to describe something clever or insightful to deal with a difficult issue — not as something deceptive. And the decline that is referred to is well-known in dendroclimatology in which the properties of annual growth rings of trees are used to infer temperature changes.

The fact is that since about 1960, tree-ring data has tended to suggest a decline in global temperatures at a time when direct instrumental measurements of temperatures show that it has clearly increased. Before 1960, tree-ring proxy measurements are consistent with other proxies for temperature change at least back to about 1600 AD. Something is obviously amiss with tree-ring proxy measurements, at least after 1960, although the reason for the divergence is not understood. What the Climategate scientists were referring to in their exchange was a known way of dealing with this inconsistency. It is important to recognize that they were not “fooling” anyone — the anomaly with tree-ring data is well-known among climate experts, as is the statistical “trick” used to legitimately reconcile the different types of data.

Yesterday, a British panel exonerated the scientists involved in Climategate, even as it criticized them for some reluctance to release computer files supporting their work. “[W]e find that their rigour and honesty as scientists are not in doubt,” the review states. This is the third review to clear the scientists of allegations of fraud and the vice-chancellor of the university has now expressed his hope that this will “finally lay to rest the conspiracy theories, untruths and misunderstandings that have circulated.”

The history of Piltdown man reminds us that we need to be on guard against scientific misconduct and fraud. But we also need to be on guard against unwarranted allegations of such misconduct when there is no sustainable evidence to show it is there.