IUCN Red List Update

IUCN has released its annual update to the Red List. Of the nearly 50,000 species surveyed, close to 20,000 are threatened. In other words, more than 1/3 of the species evaluated by IUCN are vulnerable, endangered or critically endangered.

It is high time that biodiversity loss receive at least the level of international attention that has recently been paid to climate change. As I have noted many times on this blog and elsewhere, perhaps linking those two issues will offer an opportunity for stemming some of the hemorrhaging of biodiversity. The CBD has recently released two reports (here and here) detailing scientific linkages between the issue areas.

A Broad Challenge to the FDA's Regulations: Botox Manufacturer Sues Asserting First Amendment Protection for Off Label Drug Claims

In a move that could undermine the FDA's premarket approval process for all health care products, the maker of Botox has filed a legal action against the government claiming first amendment protection for the distribution of “truthful, relevant information” to doctors regarding off-label uses of its drugs.

As Natasha Singer of the New York Times reports:

The Food and Drug Administration approves medicines for specific therapeutic indications. Once a drug is approved for a specific use, doctors are then free to use their medical judgment to prescribe the drugs for other unapproved, or off-label, uses. Manufacturers, however, are prohibited from promoting off-label uses to medical providers or advertising such uses directly to the public.

Botox, an injectable drug that can temporarily reduce muscle or gland activity, is approved in the United States to treat crossed eyes, eyelid spasms, excessive sweating, severe neck contortions and wrinkles. But many doctors use the drug for unapproved indications like facial spasms, vocal cord problems and migraine headaches. *** ‘If you could get a drug approved for one narrow use and then market it for everything else, there would be no incentive or motivation for a company to prepare data to ensure that it meets the standard for safety and efficacy,’ said Marc J. Scheineson, a lawyer specializing in food and drug regulation at Alston & Bird in Washington.

It appears that the Botox suit is claiming free speech protections that are similar to those that are currently provided for dietary supplements under the questionable decision of Pearson and Shaw v. Shalala, 1999 U.S. App. LEXIS 464 (Jan. 15, 1999). However, Pearson can be distinguished as dietary supplements are targeted to healthy portions of the population to help maintain or enhance health. Drugs are marketed to unhealthy, vulnerable portions of the population claim to aid in an individual’s struggle to return to normal health. This difference should be outcome determinative in the Botox case.

What the manufacturer of Botox wants to achieve is the ability for drug manufacturers to once again promote drugs while there is scientific uncertainty over their safety and effectiveness. It is taking the first step toward this goal by claiming this free speech in the context of communication to physicians. While the debate starts over this question, it will be prudent to recall the lessons taught by the Thalidomide case which occurred prior to the 1962 Drug Amendments and involved the distribution of drug to thousands of patients by doctors while there was still scientific uncertainty over its safety:

Thalidomide was widely distributed in Germany, Japan and the United Kingdom for sedative purposes and for the treatment of nausea in pregnancy for several years. In 1960, William S. Merrell Company, the manufacturer of the American version of Thalidomide, Kevadon, applied for FDA approval. However, it was clear to Dr. Frances Kelsey, one of the FDA officers examining the application, that the drug had not been adequately tested for safety before distribution. In spite of pressure to approve the drug placed by the manufacturer on both the FDA and Dr. Kelsey individually, Dr. Kelsey insisted that the drug needed additional testing to prove safety before FDA approval could be granted. In 1961, Dr.Kelsey learned of a possible connection between nerve damage in adults and Thalidomide. [These babies were born with phocomelia, which is a Greek word thatcombines the words ‘seal’ and ‘limb’ … where the long bones of the infants’ arms had almost completely failed to grow; their arms were so short that their hands extended almost directly from their shoulders. Their legs were less affected but showed signs of a similar distortion of growth . . . .”]. She requested that Merrell provide studies on the use of its Thalidomide product on pregnant women. In 1962, it was discovered that Thalidomide was causing serious birth defects in children. While the application for Thalidomide was pending for FDA approval,hundreds of severely deformed babies were being born in Germany. [Worldwide, it is estimated that 8,000 severely deformed babies were born because of thalidomide].Without the FDA’s knowledge, Thalidomide had already been provided to 20,000 patients in the United States as part of an 'investigational study.' Slaying the Hydra.

Part Three: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

An Introduction to the History of Quack Medicine

In the late nineteenth and early twentieth centuries there was a remarkable growth in the marketing of sham products to treat and cure disease.

At that time, the rate at which quack medicines were being introduced into the market far outpaced the development of the science necessary to establish the efficacy and identify the risks associated with each new product. This scientific lag time created a period when there was an information void that
predatory commercial interests were quick to use to their advantage. As the FDA carried the burden of proof to show that a product did not work or was unsafe in order to remove the product from the market, during this lag time predatory commercial interests were able to profit from scientific uncertainty to the detriment of public health.

During this long period in U.S. history, the curative claims of the predatory sham medicine salesmen were limited only by the gullibility of their targets. In many cases, the degree of gullibility was proportional to the level of desperation of the individual for a cure. The more dire the condition, the more vulnerable an individual was to the ‘flim flam’ of the greedy snake oil salesman. And the more dire the condition, the greater the degree of harm when the sham medicine did not work, causing injury over and above the original illness and/or causing a delay in seeking effective medical treatment. Thus, this lag time between initial marketing of a sham product and the development of the science necessary to resolve uncertainties over the new product’s safety and effectiveness was very costly in terms of human suffering and loss of life. Slaying the Hydra: The History of Quack Medicines

In 1962, after a series of highly publicized public health crises, legislation was passed to close this ‘space between’ created by scientific uncertainty by switching the burden of proof for safety and effectiveness from the FDA and onto product manufacturers.

As more fully discussed in the next entries in this series,

it was not until 1962 that legislation was passed that required manufacturers to obtain premarket approval for new drugs from the FDA by producing “substantial evidence” that the product is both safe and effective for its intended use. The Drug Amendments of 1962 allowed the FDA to make the transition
from its former inefficient and costly police role of enforcing specific statutory prohibitions by removing adulterated and misbranded products from the market, to its current gatekeeper role of preventing those products from entering the market in the first place. Thus, from 1962 until 1994, manufacturers were no longer able to ‘play in the grey’ and take commercial advantage of the scientific uncertainty over the safety and effectiveness of a product to the detriment of public health.

The legislative history of the FDCA makes it clear that Congress also intended that weight loss products fall into the same regulatory category as drugs and devices specifically to deal with predatory profiteering by product manufacturers that targeted a vulnerable population of those who were overweight or obese. In the legislative record, members of Congress expressed their intent to deal with the massive number of “worthless” products being marketed for weight loss at the time. Id.

Thus, prior to the passage of The Dietary Supplement Health Education Act (“DSHEA”) and the Nutritional Labeling Education Act (“NLEA”), the FDCA appears to have required that manufacturers of weight loss supplements obtain premarket approval by establishing the safety and effectiveness of their products before distributing them.

However, the passage of DSHEA in 1994 has confused this situation. To date, it appears that DSHEA is being interpreted to shift the burden of proof back onto the FDA with relation to dietary supplements marketed to both healthy populations and vulnerable, unhealthy populations.

With this over broad interpretation, predatory commercial interests are again being allowed to exploit scientific uncertainty. The door has now been re-opened to the same deceptive advertising that ran rampant in the late nineteenth and early twentieth centuries.

And unfortunately, tens of millions of vulnerable and desperate individuals who are overweight and at grave risk of developing a serious, chronic disease are being lured into this predatory playground. The United States has now come full circle and returned to the era of the snake oil salesman. The very public health problem that the FDCA was originally promulgated to deal with, fraudulent and deceptive products that put the nation’s health at risk, has reared its ugly head once again. Id.

The next blog post in this series delves into more details regarding the history of the quack medicines to give additional perspective to the relationship between the FDCA, the FDA and predatory commercial interests.

Post Two of a Series: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

The first post of this series began by asking whether functional foods should be regulated as drugs if they claim to treat abnormal health conditions. For example, was it appropriate for the FDA to characterize Cheerios as a drug as a result of its advertising claim that “you can Lower Your Cholesterol 4% in 6 weeks?” An abnormally high cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. By virtue of its claims to help this group of unhealthy consumers with their struggle to return to a normal state of health, should the manufacturer of Cheerios be required to undergo the FDA's premarket approval process to show that eating Cheerios is effective in lowering cholesterol as claimed?

The answer to this question may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status – weight loss products.

The Obesity Crisis and Weight Loss Products

The United States’ obesity crisis is gaining momentum. In only fifteen years, eighty percent of Americans will be either overweight or obese. Being overweight or obese places an individual at a significant risk for developing hypertension, Type II diabetes, heart disease, stroke and cancer.

Conservative estimates predict that the health care costs associated with this epidemic will reach $956.9 billion in the 2020s. One of every six dollars spent on health care will be associated with the conditions of being overweight and obese. Significantly, for the first time in over a century, children and young adults will have a shorter life expectancy than their parents.

"This obesity epidemic has been matched by a rapid growth in the weight loss supplement industry. Overweight consumers desperate to lose weight are being lured by ‘magic bullet’ claims into purchasing ‘quick-fix’ weight loss supplements in order to lose weight and decrease their risk for disease. As the result of prodigious marketing campaigns, many adults and adolescents ... are turning to weight loss supplements as an alternative to diet modification and exercise.

Advertisements for the ‘quick-fix’ product that works to melt off pounds without diet or exercise, some even while you sleep, are everywhere. Enforma Natural Products, Inc. ran an infomercial marketing its product Exercise in A Bottle claiming it “helps your body burn more calories while you’re just standing or sitting around doing nothing – even while you are sleeping” and “[y]ou can enjoy all those delicious foods like fried chicken, pizza, cheeseburgers, even butter and sour cream, and stop worrying about the weight.” The manufacturer of a similar product called Maxiline advertised heavily by taking out full-page newspaper advertisements stating “[s]leep … and lose weight in just a few nights … you eat whatever you want.” The advertisement stated that the product worked because “the body’s fat cannot defend itself from attack while asleep.”

Commercials on television and radio, lengthy infomercials, magazine advertisements, mass mailings of brochures and Amway and “Avon-Calling” type visits from friends and neighbors hawking miracle potions for magical weight loss flood the American consciousness. In 2000, the sale of weight loss supplements in the United States reached $4.7 billion, with a projected increase of ten to twenty percent annually.

In the book Through the Looking Glass, Alice said, “[o]ne can’t believe impossible things.” The White Queen answered: “I daresay you haven’t had much practice . . . . When I was your age . . . I’ve believed as many as six impossible things before breakfast.”

Like Alice, for many, the impossible weight loss claims made by the current breed of snake oil salesmen defy credibility. However, viewed in context, these beliefs are more understandable. Many of these consumers, and, shockingly, their physicians, incorrectly believe that the FDA requires premarket testing to establish that these weight loss supplements are both safe and effective. In fact, the FDA does not require that these products undergo clinical testing for safety or efficacy prior to being placed on the market. This vast market exists in spite of the fact that there is little to no evidence that most of these products actually work. To the contrary, there is growing evidence that many are ineffective and unsafe.

In 2002, the FTC issued a report that fifty-five percent of the claims made within advertisements of over-the-counter weight loss products were either false or misleading. According to the FTC, more consumers are defrauded by weight loss products than any other product it has examined." Slaying the Hydra: The History of Quack Medicines

Why isn’t the FDA using its premarket approval authority to keep these sham products from entering the market in the first place? Not surprisingly, the weight loss supplement industry is marketing its products as dietary supplements and is claiming the safe haven protections from FDA regulation offered under the Dietary Supplement Health Education Act (“DSHEA”) and the National Labeling Education Act of 1990 (“NLEA”). What is surprising is that the FDA appears to agree. Are the weight loss supplement industry and the FDA correct?

The next several posts in this series will examine the history of the relationship between the FDCA, the FDA and predatory commercial interests and will ask whether there are lessons from the past that can assist in the analysis of current regulatory issues involving food, functional food and dietary supplements. If so, do these lessons also offer insights into the regulation of nanotechnology used in consumer products for direct and indirect human consumption — including food (directly and through the food production process), food supplements, cosmetics and sunscreens?

Advancing Biodiversity Protection in International Negotiations

What is the most important opportunity for advancing biodiversity protection in the near term? Given the uneven distribution of species throughout the globe, and the rapid destruction of habitat in many developing countries, the appropriate scale is global with local and regional implimentation.

The most obvious possibilities for developing global regulation, such as the Convention on Biological Diversity (CBD), remain limited by problems that were present at their interception. The CBD contains only qualified commitments as a result of developing countries’ concern for sovereignty and development prerogatives, and the unwillingness of developed countries to financially support formal protection of biodiversity and habitat. Similar problems plague other global efforts to preserve habitat, such as forests and wetlands. These traditional, direct attempts to regulate biodiversity and habitat loss continue to come up short and the prospects for dramatic improvements to in situ preservation through them are dim.

In contrast, the forthcoming COP-15 negotiations under the UN Framework Convention on Climate Change offer a unique and potentially very powerful opportunity to re-orient the financial and political incentives that have undermined global biodiversity and habitat agreements. The expected inclusion of a “reduced emissions from deforestation and degradation” (REDD) mechanism offers a key chance to recognize an unusual alignment of interests in preservation of tropical forests that benefits biodiversity. REDD will ultimately create a market for trading carbon credits generated through avoiding deforestation (which currently releases far more carbon dioxide per year than complete compliance with the Kyoto Protocol would prevent). After an initial setup phase, REDD will likely include tradable offset credits that simultaneously generate more wealth for tropical forest nations than current destructive activities (such as clearing for agriculture) and allow developed nations to meet emissions limitations requirements more cheaply than domestic retrofitting could acheive.

With financial incentives to conserve tropical forests, perhaps the hurdles to effective biodiversity preservation can be overcome. Further, biodiversity preservation is of fundamental importance for successful adaptation during climate change, particularly in poor areas of many developing countries, and is an appropriate design consideration in the climate regime. Indeed, many REDD proposals highlight potential biodiversity “co-benefits” that could materialize. However, none offers a mechanism that would ensure their realization.

Tropical forests are among the most biodiverse ecosystems on earth, but not all are equal. Those forests that pose the most urgent priorities for preserving biodiversity are frequently fragmented and relatively small. Thus, the purely carbon-centered approach to REDD that currently dominates most proposals does not assure net benefits for biodiversity and may even prove worse than the status quo.

As I explain in a short article published today in the Carbon & Climate Law Review, if REDD is really going to materialize as a powerful force for biodiversity protection, its design must include a mechanism to identify and reward REDD projects that preserve biodiversity priority areas. Through designation of biodiversity-enhancing projects, together with added financial incentives for developing and investing in them, REDD could become the most effective tool yet for stemming the sixth mass extinction.

Post 1 in Series: The Relationship Between the Level of Government Regulation under the FDCA and the Health Status of a Product’s Targeted Population

Cheerios -- a Drug?

This past May, the FDA issued a warning letter to General Mills stating that the claim on Cheerios cereal that “you can Lower Your Cholesterol 4% in 6 weeks” turned the Cheerios from a food into an illegally marketed drug. When bloggers heard the news, posts ran from scolding the FDA to “grow-up,” to those which lauded the FDA’s action.

Who is correct? Is targeting a cereal one of those cases where, as one blogger suggested, the FDA has its priorities wrong? A look at one recent food trend may help answer this question.

By making its cholesterol lowering claims, Cheerios is entering the growing market for functional foods. In 2008, functional foods -- which are defined as foods that claim to have health benefits over and above the delivery of nutrients -– were a $30.7 billion dollar market. This market is predicted to grow by 40% over the next several years.

Examples include: probiotics in salsa and ketchup; omega-3 fatty acids in orange juice, eggs and peanut butter; pasta enriched with calcium; heart healthy ginger ale infused with green tea; ‘energy’ drinks with amino acids for joint health. The list goes on and on. One never knows what might pop up in a favorite food.

And now a new category of functional foods is cropping up which industry is calling cosmeceuticals -– foods that are being marketed to enhance appearance. (A bit confusing because that term is commonly used to describe drugs that are being marketed as cosmetics. Perhaps cosmefood would be better?). One example of a cosmeceutical for skin beauty is a product on the market that consists of marshmallows infused with allegedly skin-boosting collagen.

Fortified foods are not new. Iodine has been added to salt since 1924 to reduce the incidence of goiter. Grains have been fortified with niacin, thiamin, riboflavin and iron since 1943, a public health move that almost eliminated brain/skin degenerating pellagra within a decade. However, present day functional foods are flooding onto the market before the science exists on the effectiveness of many of their associated health claims.

Where should the FDA draw the line on regulation? Should the level of product regulation be linked with the health status of the product’s targeted population? While not stated explicitly, it appears that this is the strategy that the FDCA has followed since its inception. See Van Tassel, K., Slaying the Hydra: The History of Quack Medicine, The Obesity Epidemic and the FDA's Battle to Regulate Dietary Supplements, 6 Indiana Health L. J. 203-251 (2009).

Traditionally, the greatest amount of regulatory protection under the Food Drug & Cosmetic Act (“FDCA”) has been applied when products are targeted at vulnerable, unhealthy populations and claim to aid in an individual’s struggle to return to normal health. Examples of products that fall into this category by making health remedy or recovery claims include drugs and devices. For these products, the modern FDCA establishes a premarket enforcement process that places the majority of the cost and burden on the product manufacturer to establish safety and efficacy through the clinical trial process prior to distribution to the public. Without premarket approval from the FDA, these products will be deemed both adulterated and misbranded as a matter of law.

Conversely, the FDCA requires less regulatory protection when products are targeted to healthy populations to maintain or improve a normal state of health. Examples of products that fall into this category are traditional foods, and (until recently) a very limited number of functional foods and (once again, until recently) a similarly narrow category of dietary supplements. For these products, the FDA carries the burden of removing an unsafe or ineffective product by proving that it is adulterated or misbranded.

Currently, far too many functional foods and dietary supplements are being marketed to the unhealthy and vulnerable by making health recovery or remedy claims without demonstrating through premarket approval that their products are both safe and effective. It appears that Cheerios is just one product of many that are making these claims.

An abnormally high cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. Cheerios is claiming to help this group of unhealthy consumers with their struggle to return to a normal state of health. As one commentator remarked, it is possible “that some people with high cholesterol will see eating breakfast as a clinical treatment, perhaps even offsetting a more pressing need to cut back on French fries.” Consequently, by sending its warning letter to Cheerios, it appears that the FDA is heading down the right path.

The merits of the FDA’s position on Cheerios specifically, and functional foods more generally, may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status -– weight loss products.

The next in this series of blog posts will provide a general introduction of the current problems with the claims being made by weight loss products, particularly in the context of the obesity crisis. The focus on the example of weight loss products will provide a structure for the following posts which will take a look back through the history of the relationship between the FDCA, the FDA and predatory commercial interests. Through this exercise, regulatory patterns will be identified that appear to link the level of product regulation with the health status of the product’s targeted population.

The goal of this series is to take lessons from the past and apply them to assist in the analysis of current regulatory issues involving food, functional food and dietary supplements. This first series will provide the ground work for the second series which will delve into the use of nanaotechnology in consumer products for direct and indirect human consumption -- including food (directly and through the food production process), food supplements, cosmetics and sunscreens.

— KVT

The rhetorical orgin of Sarah Palin's "death panel"

Despite her July 26, 2009, resignation as governor of Alaska, Sarah Palin remains a formidable political force. She has shifted her primary written platform from Twitter to Facebook.

Sarah Palin's Facebook page has had an immediate and profound impact on national politics. Her Statement on the Current Health Care Debate notably handed opponents of health care reform a potent rhetorical weapon:

The Democrats promise that a government health care system will reduce the cost of health care, but . . . government health care will not reduce the cost; it will simply refuse to pay the cost. And who will suffer the most when they ration care? The sick, the elderly, and the disabled, of course. The America I know and love is not one in which my parents or my baby with Down Syndrome will have to stand in front of Obama’s “death panel” so his bureaucrats can decide, based on a subjective judgment of their “level of productivity in society,” whether they are worthy of health care. Such a system is downright evil.

Health care reform, whatever its virtues or drawbacks, will do no such thing. That at any rate is my belief; I side with those observers who believe that Palin's fictional "death panel" has grotesquely wounded political discourse on health policy. But my objective here is not political. I aim simply to trace the rhetorical origin of the term death panel.

In all of American law, exactly one phrase carries a resonance comparable to death panel. Its source is undoubtedly familiar to Sarah Palin: the Endangered Species Act Amendments of 1978, Pub. L. No. 95-632, 92 Stat. 375. In an effort to inject more flexibility into the act after TVA v. Hill, 437 U.S. 153 (1978), the 1978 amendments created the Endangered Species Committee and empowered it, upon a vote of no fewer than five of its seven members, to exempt a federal agency from section 7 of the original Endangered Species Act of 1973. These conditions must be met before the committee authorizes a section 7 exemption:

1. There must be no reasonable alternative to the agency's action.
2. The benefits of the action must outweigh the benefits of conserving the species.
3. The action is of regional or national importance.
4. Neither the federal agency or the exemption applicant made irreversible commitment to the resources.

Of course, no one calls the Endangered Species Committee by that name. Everyone calls it the God Squad. That name is apt, not because the committee possesses "collective wisdom but because the decisions it may render were once left to an even higher authority."

As governor of Alaska and as an avid, lifelong hunter, Sarah Palin has been quick to find fault with federal environmental law. She is no fan of aggressive enforcement of the Endangered Species Act. That statute's God Squad restores some of the anthropocentric "balance" that one might imagine Sarah Palin to favor. Strange though it may seem, this rarely invoked provision of the Endangered Species Act may well have triggered the poetic imagination of Sarah Palin. The "God Squad" appears to given her the rhetorical weapon by which to condemn the feared potential of health care reform to assume divine power over life and death.

Assiting Migration of Trees in the Northwest

Associated Press reports on a large-scale Canadian project to plant 16 tree species in areas that may be more suitable to them as climate change. The project involves several planting sites in British Columbia and the Northwestern United States. Geneticist Gregg O'Neill, who heads the project, notes the need to plant trees that can thrive over the next 80 years while the climate changes. British Columbia has also relaxed its elevation restrictions on re-planting by timber companies in an effort to facilitate adpation of tree species to climate change. The assisted migration project's website is here.

In other forest news . . .

After my post on the WOPR withdrawal, I came across this much less publicized news item on administration logging decisions. On the same day as the WOPR withdrawal, Secretary of Agriculture Tom Vilsak approved a 381 acre clear-cut of primary forest (the Orion North timber sale) in a roadless area of the Tongass National Forest in Thorn Arm, near Ketchikan.

This decision represents the first approval under Vilsack's May 2009 memorandum reserving decision-making authority to approve or disapprove timber contracts in roadless areas. This policy is the latest turn in the evolution of the 2001 Roadless Rule, which was permanently enjoined by a 2008 Wyoming District Court decision roughly 18 months after the District Court for the Northern District of California enjoined the Forest Service from taking any action contrary to the 2001 Roadless Rule, leaving the Forest Service in a bit of a quandary.

Vilsack's May 2009 memorandum reportedly drew some praise from environmentalists and democrats, apparently banking on Obama's campaign promises to support the roadless rule. The decision to move forward with the Orion North sale has drawn sharp criticism from environmentalists and others. For example, the Environmental News Service quotes Carol Cairnes, president of the board of the Ketchikan-based Tongass Conservation Society: "The day when this kind of timber sale made sense is long gone. . . . Cutting these trees will not even bring in half the money the Forest Service will spend building a road to get to the trees." The sale will require building or updating eight miles of roads, which Tom Waldo of Earthjustice (which was challenging the Orion North sale prior to Vilsack's decision) states will cost four times as much as the profit from the sale. According to the Juneau Empire, the approval was driven by the secretary's recognition of "how much people in the area needed the jobs and the economic boost."


In reporting the Orion North sale, MongaBay.com reports: "The U.S. has the world's seventh highest rate of primary forest loss in the world. Between 2000 and 2005, the United States lost an average of 831 square miles (215,200 hectares) of "primary forest" -- defined as forests with no visible signs of past or present human activities." The website, an exceptional source of biodiversity-related news, then notes the high biodiversity levels found in primary forests, as well as their priority place in conservationists' agendas. Indeed, primary forests frequently provide irreplaceable services (see here for a freely-available study of tropical forests reaching this conclusion).

The Orion North sale tempers my enthusiasm at seeing the WOPR withdrawal, and gives me concern for the future of "balancing" irreplaceable remnants of national forests against temporary and questionable economic benefits. Hopefully, the 2001 Roadless Rule will be re-instated, or the administration will otherwise move toward a uniform approach to logging that favors primary forest preservation and works to concentrate logging in secondary forests without particularly important ecologial benefits and to existing timber plantations.

Withdrawing the WOPR

Interior Secretary Salazar withdrew the Western Oregon Plan Revision (WOPR) today. The Department of Interior news release begins: "Because the previous Administration failed to follow established administrative procedure before leaving office, its plan to intensify logging in western Oregon – known as the Western Oregon Plan Revisions (WOPR) – is legally indefensible and must be withdrawn."

The WOPR was adopted by the Bush administration in late 2008 to dramatically increase the amount of logging that would be allowed under the Northwest Forest Plan. The Northwest Forest Plan grew out of the extraordinarily contentious spotted owl controversy during the Clinton administration. Environmental groups fiercely opposed the WOPR. In creating the WOPR, the Bush adminstration disregarded Endangered Species Act consultation requirements (for posts on another Bush administration consultation action see here).

Withdrawing the WOPR is a significant step in favor of environmental protection on the part of the Obama administration because it supports preservation of the spotted owl, Pacific salmon, and the remaining old-growth forest of Oregon. Further, the administration is seeking to vacate a 2008 critical habitat revision for the spotted owl. The moves are particularly notable endorsements of environmental protection considering the strong condemnation to be expected from timber-dependent communities that have been hard-hit by the logging reductions of the 1990s and the current economic recession.

At least equally important, the WOPR and the critical habitat revision were tainted by the involvement of Julie MacDonald, the Bush-era Deputy Assistant Secretary found to have been "heavily involved in . . . reshaping scientific reports" despite her lack of a scientific background, among other things. Further, the WOPR's allowence of increased logging was in contrast to the majority of the 30,000 comments received and over 250 formal protests submitted.

Salazar's announcement included a promise to engage the community and follow legal process requirements in developing a new plan revision. This aspect of the announcement, at least, is welcomed by even timber industry representatives, some of whom joined a lawsuit based on concern that the WOPR was vulnerable to legal challenge. It is also yet another welcome change from the prior administration.

Law And Neuroscience In Italy

The European Science Foundation will be holding a fascinating research conference on law and neuroscience this fall. The conference is entitled "LAW AND NEUROSCIENCE: OUR GROWING UNDERSTANDING OF THE HUMAN BRAIN AND ITS IMPACT ON OUR LEGAL SYSTEM", and its aim is

to establish a dialogue between neuroscientists, legal practitioners, researchers in sociolegal studies and social scientists, to further mutual understanding and make some realistic evaluations of the potential developments at the intersection of neuroscience and law.

A star-studded cast of law and neuroscience scholars address fascinating issues in one of the most important emergent fields of law, including:

* The legal and societal impact of recent neurobiological research on aggression, impulsivity and anti social conduct;
* The impact of brain imaging technologies on the criminal justice system. Impact of neuroscience on criminal responsibility, sentencing and punishment;
* Evidence from current cases in criminal and civil law on the impact of neuroscience on witness credibility and the rules of evidence. Problems, possibilities and perils of neuroscience based lie detection;
* The implications of the use of neuroscience for screening, risk prediction and preventive interventions;
* Challenges to law and regulation in Europe posed by the neurosciences.

The conference has the additional benefit of taking place in Acquafredda di Maratea, Italy. Abstracts may be submitted until July 16, 2009, and conference will take place from October 26th-31st, 2009. Full details, including the preliminary program, lodging options, and application forms are available at the conference website.

Interesting New Book on the Transatlantic GMO Divide

Oxford University Press just published an interesting new book: When Cooperation Fails: The International Law and Politics of Genetically Modified Foods by Gregory Schaffer and Mark Pollack.

I will review the book after I have read it. For now, I will just whet your appetite with OUP's description of the book:

The transatlantic dispute over genetically modified organisms (GMOs) has brought into conflict the United States and the European Union, two long-time allies and economically interdependent democracies with a long record of successful cooperation. Yet the dispute - pitting a largely acceptant US against an EU deeply suspicious of GMOs - has developed into one of the most bitter and intractable transatlantic and global conflicts, resisting efforts at negotiated resolution and resulting in a bitterly contested legal battle before the World Trade Organization. Professors Pollack and Shaffer investigate the obstacles to reconciling regulatory differences among nations through international cooperation, through the lens of the GMO dispute. The book addresses the dynamic interactions of domestic law and politics, transnational networks, international regimes, and global markets, through a theoretically grounded and empirically comprehensive analysis of the governance of GM foods and crops. They demonstrate that the deeply politicized, entrenched and path-dependent nature of the regulation of GMOs in the US and the EU has fundamentally shaped negotiations and decision-making at the international level, limiting the prospects for deliberation and providing incentives for both sides to engage in hard bargaining and to "shop" for favorable international forums. They then assess the impacts, and the limits, of international pressures on domestic US and European law, politics and business practice, which have remained strikingly resistant to change. International cooperation in areas like GMO regulation, the authors conclude, must overcome multiple obstacles, legal and political, domestic and international. Any effective response to this persistent dispute, they argue, must recognize both the obstacles to successful cooperation, and the options that remain for each side when cooperation fails.

Mighty Sweet

There are many things that make life worth living, but two of the greatest have to be time outdoors working with nature (such as gardening) and time with one's children. The two of these intersect for me everytime my kids help me plant, maintain or harvest a garden -- a great way to build their familiarity and comfort with the outdoors, and to teach them about where food comes from.

In the tradition of Jim Chen's many musical posts, here is the lyric that evokes this intersection for me (from Greg Brown's "Mighty Sweet Watermelon"):

Sunflowers dancing like my daughters do.

Life gets old, love makes it new.

Come on down and meet us in the garden.

The full song is available free here:
http://new.music.yahoo.com/greg-brown/tracks/mighty-sweet-watermelon--42166999

Continued Life for the ESA

I share Andrew Torrence's concern that climate change may be taking priority over biodiversity conservation. (However, as I've expressed previously, I think the attention garnered by climate change can be harnessed to more effectively address some of the most challenging and critical issues of biodiversity conservation). Nonethless, I think that the polar bear is a long way from the snail darter and the role of the ESA in its conservation presents a fundementally new question of the ESA's scope and intent.

Polar bears, of course, remain listed under the ESA (see posts here, here, here, and here). Further, federal agencies are still required to consult with FWS where their activities may affect the polar bear because FWS recently revoked a Bush-era midnight regulation that, among other things, essentially eliminated the consultation requirement for GHG emissions. The 4(d) rule that FWS recently decided to retain intersects with consultation by eliminating the need for incidental take permits for certain activities that may cause a take -- most significantly, GHG emissions.

The broader effect of the 4(d) rule, in my view, is to firmly establish that FWS will not attempt to set climate change policy for the nation. The rule also avoids the potentially unmangeable issues that would be created if FWS had to approve all federally-authorized GHG emissions through the consultation process. While I support a strong reading of the ESA, as embraced in TVA v Hill, expanding FWS' authority to include a final say on all GHG authorizations takes us into uncharted territory.

FWS should be consulted on GHG issues, and biodiversity conservation must be a major consideration in the creation of national GHG policy. However, this policy will be more socially and politically tenable, I think, if it arises through a process that is more organic than FWS consultation. Ultimately, it seems impossible that FWS authority over GHG emissions would craft a lasting climate change policy. It would, instead, pressure Congress to create such a lasting policy. That pressure is already building, and the ESA faces a greater risk of being weakened if FWS asserts authority over power plants to protect the polar bear because Congress would be forced to address that question in crafting a new regime.

The ESA has a role at the intersection of climate change and biodiversity. It is a role that is not likely to be filled by any other statute or policy, and it is critical. The ESA is the strongest bit of ecocentric legislation in the U.S., and perhaps the strongest biodiversity legislation in the world. Its role during a phase of climate change is to ensure that other species are not left out of the adaption equation as we humans scramble to change our behavior. In other words, the ESA can call attention to the impacts of climate change through lisitings (as FWS may well do with the pika) and should preserve or create every available option for the polar bear and other climate-threatened species to survive the impacts of climate change. This is an important function that the ESA can fill, and perhaps serve as a model for the international level where a similar problem must be addressed.

The Day The Endangered Species Act Died

The Obama Administration announced today, through Secretary of the Interior, Ken Salazar, that it would not break with the Bush II Administration's policy of abandoning the Polar Bear to its fate. Despite both the clear intent and letter of the Endangered Species Act to contrary, Secretary Salazar stated that "The Endangered Species Act is not the appropriate tool for us to deal with what is a global issue, and that is the issue of global warming".

Faced with a similar issue in TVA v. Hill (1978), 437 U.S. 153, 172-173, the United States Supreme Court surprised everyone by explaining that

It may seem curious to some that the survival of a relatively small number of three-inch fish [the Snail Darter] among all the countless millions of species extant would require the permanent halting of a virtually completed dam [that is, the Tellico Dam] for which Congress has expended more than $100 million. The paradox is not minimized by the fact that Congress continued to appropriate large sums of public money for the project, even after congressional Appropriations Committees were apprised of its apparent impact upon the survival of the snail darter. We conclude, however, that the explicit provisions of the Endangered Species Act require precisely that result.

The Court went on to emphasize the intentional strictness of the Endangered Species Act:

One would be hard pressed to find a statutory provision whose terms were any plainer than those in [Section] 7 of the Endangered Species Act. Its very words affirmatively command all federal agencies "to insure that actions authorized, funded, or carried out by them do not jeopardize the continued existence" of an endangered species or "result in the destruction or modification of habitat of such species . . . ." 16 U.S.C. 1536 (1976 ed.). This language admits of no exception.

Although the Obama Administration has announced its intention to face the climate change crisis with, as yet unannounced, comprehensive measures, the decision to set the Polar Bear adrift, both figuratively and literally, hints at an emerging hierarchy of environmental priorities: climate change comes before biodiversity conservation. This decision - to conduct biodiversity conservation a la carte - was not what Congress had in mind when it passed the Endangered Species Act; in fact, it represents exactly what Congress feared would happen unless it legislated clearly and strongly.

For those who hope for bipartisan cooperation in D.C., perhaps this represents progress: Democratic and Republican administrations have now co-signed the death warrant of the Polar Bear, and have begun the process of exsanguinating the Endangered Species Act.

Sustainably Cloned Cows

I don't get it. When I saw the ad in which Cyclone Dairy touting its milk from cloned cows, I naturally clicked through to the website. I expected either a clever parody, ala The Onion, or an anti-GMO rant in cow's clothing. I was very disappointed.

If the site aspires to parody or rant, it fails on both counts. Instead, it is an odd pastiche of semi-plausible claims couched in language that was obviously intended to inflame the fury of those opposed to cloning, GMOs, rBGH and other agricultural biotechnology.

A particulalry nice touch is the photo of the pregnant woman proclaiming:

I trust the perfect cows at CyClone Dairy to provide nothing but the best milk for me and my baby.

I am waiting for the other shoe to drop.

Perpetuating science illiteracy

Now that my own family has solidly entered the world of coloring books and dinosaur p.j.s, this particular combination of dinosaurs and coloring books struck a raw nerve. I am not convinced it is real (seems too absurd, even for young earthers) but the image and text certainly capture the level of science illiteracy fostered by evolution denial. I find the kind of willful blindness and commitment to ideology over all else embodied by this drawing (regardless of whether it is an actual coloring book or not) to be frightening.

Picking and choosing among scientific principles to suit political or religious ideology is dangerous. For one thing, that kind of thinking bleeds so easily into climate change denial. We desperately need a renewed commitment to scientific research if we are to address the looming problems of catastrophic global warming and climate change. Taking a leaf from the Tobacco Institute, evolution deniers, like climate change deniers chant "not proven" for things not susceptible to the particular and highly specialized kind of proof they demand. Yet, the evidence is overwhelming, and the scientific consensus virtually unanimous. We have no time to waste re-debating well-settled propositions.

Better REDD than Dead: Biodiversity in the Climate Regime

What is the best opportunity to secure effective international legal protection for biodiversity in the near term? It does not currently seem to be proceedings under the Convention on Biological Diversity (CBD). Nor is it likely to lie under international efforts aimed exclusively at habitat protection, such as the UN Forum on Forests. These efforts were largely unsuccessful from their inception at the 1992 Rio Earth Summit and the reasons for those failures continue to plague the regimes.

The body of international environmental law receiving the most attention recently is plainly the climate change regime. Yet, in its current form, it provides virtually no sign of legally requiring attention to biodiversity issues. Even where it comes closest, in the potential regulation of reforestation and afforestation projects under the clean development mechanism, the climate regime remains clearly – and from a biodiversity perspective, counterproductively – focused exclusively on net aggregate emissions of greenhouse gases.

As climate change progresses, however, maintenance of biodiversity becomes all the more pressing. Climate change itself will create strong pressures on species and ecosystems, causing a need for migration or evolution. Migration will be limited by fragmentation of habitat, as well as non-anthropogenic factors (such as the inability of mountain-top communities to move upwards in response to warming at higher elevations). Thus, significant extinction is a likely impact of climate change. At the same time, biodiverse ecosystems, such as primary tropical forests, offer an array of ecosystem services that offer major adaption value. Regulation of micro-climates, provision of freshwater, and similar services offer the potential to reduce climate change impacts or at least provide a bridge into a different climactic future. This value is essentially unrecognized by any formal mechanism of the climate change regime.

Since 2005, however, the Conference of the Parties (COP) to the UN Framework Convention on Climate Change have recognized the possibility of creating some form of economically valuable credit for reducing emissions from deforestation and degradation (REDD). Indeed, since the 2007 COP meeting in Bali, it has become increasingly likely that some form of REDD credit will be created. The target date for agreement on this and many other elements of the climate change regime is December 2009 when the COP meets in Copenhagen, Denmark.

Will REDD offer a means of securing biodiversity protection? It could. Tropical forests are among the most biodiverse ecosystems on the planet. At the same time, they have been steadily disappearing for decades. If REDD were able to make tropical forest preservation more profitable than tropical deforestation, it could overcome the hurdles that have tripped-up prior efforts to protect our rich biological heritage. REDD offers a way around the question of national sovereignty over forests because it leaves to countries the choice of whether the program should be implemented and how ecosystems are preserved. It simultaneously offers the potential to offset both direct drivers of deforestation – such as expansion of industrial agriculture – and the indirect drivers – such as poverty and lack of governance capacity. It is, potentially, an excellent example of a legal mechanism that can re-orient the financial market incentives of behavior affecting the environment. With appropriate benchmarks and payment systems, REDD could make it more profitable to preserve forests than to destroy them, and foster development of the institutional capacity to achieve commitments.

But even if the financial incentives are aligned to make REDD successful, will it protect high-biodiversity forests? Not necessarily. Protection solely for avoiding carbon dioxide emissions does not naturally equate to protection of the most significant biodiversity habitats. It could even increase the pressure on such forests by taking other areas off the table of options for, inter alia, global agricultural production. If all that REDD does is to create value for the carbon stored in trees, this "leakage" concern may make no more valuable a mechanism than the current CBD processes.

Is there a way around this problem – a way to make REDD a tool for biodiversity protection? I think there is. The keys lie in program design. This is an argument that I recently spelled out during a presentation at the University of Aarhus in Denmark. Although the issue is complex, the essence of the solution lies in purposefully designing the regime in a way that makes biodiversity a priority for REDD. In financial terms, this means creating some form of additional value – whether for investors or for tropical forest owners – in the REDD credits generated by high biodiversity forests. As I will elaborate in the near future, articulating a biodiversity element to REDD is not only legitimate under a regime aimed at addressing climate change, it is a virtual necessity. It provides both climate and biodiversity benefit while aliviating some of the ills born of fragmentation in our international legal regimes addressing environmental issues.

Climate change law is about more than reducing emissions. As important as the concentration of greenhouse gases in the atmosphere is, an exclusive focus on that concern is myopic. Even under the best of scenarios, we will have to adapt to changes in the global climate for decades to come. That change threatens to dramatically increase the rate of biodiversity loss. Yet, the presence of rich biological diversity, as well as the intact habitats necessary for its maintenance, offers one of our best insurance policies against suffering negative impacts of that change. One way or another, it is high time we recognize the value of that insurance – for climate change events and other forms of environmental impact. REDD is the best bet among the options currently on the table for international negotiations . . . if it is structured appropriately. Those concerned with biodiversity preservation should, therefore, work vigorously over the next few months to develop and advance a framework for REDD that will realize its potential benefits for our rich biological legacy, and eliminate the risk that REDD will become but another fragmented and partially counterproductive element of a well-intentioned and incompletely-realized effort to bring about international legal consensus that actually betters the state of our fragile planet.

Endangered Species Act: Consultation Rules Restored

The Washington Post reports that the Obama administration has instructed agency officials to follow long-standing ESA consultation rules while the Departments of Commerce and Interior review midnight consultation regulation changes by the Bush administration.

This is but one of many signs the Obama presidency will be far more proactive about addressing environmental issues than its predecessor.

Darwin's beautiful mind, still not fully appreciated

George Richmond, Charles Darwin (1840)

Nicholas Wade's reflections on Charles Darwin upon the bicentennial of his birth and the sesquicentennial of The Origin of Species resonate strongly. It is often said that progress in a science is measured by the speed with which its founders are forgotten. That serious scientists — let alone the American public — continue to debate The Origin and The Descent of Man testifies to the extent to which Darwin was able to accomplish four intellectual breakthroughts that evidently still elude some contemporary scientists:

• Natural selection has no purpose at all.
• Progress is not inevitable.
• Humans are living organisms and therefore subject, all the way down to the workings of the so-called "mind" and all the way up to so-called "culture," to natural selection and sexual selection.
• Group selection applies to humans, too, no matter how willfully humans want to see themselves as individual actors.

This subject could consume both Jurisdynamics and BioLaw for months, but it suffices for the moment to quote a few paragraphs from Nicholas Wade's article:

It is somewhat remarkable that a man who died in 1882 should still be influencing discussion among biologists. It is perhaps equally strange that so many biologists failed for so many decades to accept ideas that Darwin expressed in clear and beautiful English.

The rejection was in part because a substantial amount of science, including the two new fields of Mendelian genetics and population genetics, needed to be developed before other, more enticing mechanisms of selection could be excluded. But there were also a series of nonscientific considerations that affected biologists’ judgment.

In the 19th century, biologists accepted evolution, in part because it implied progress.

“The general idea of evolution, particularly if you took it to be progressive and purposeful, fitted the ideology of the age,” says Peter J. Bowler, a historian of science at Queen’s University, Belfast. But that made it all the harder to accept that something as purposeless as natural selection could be the shaping force of evolution. “On the Origin of Species” and its central idea were largely ignored and did not come back into vogue until the 1930s. By that time the population geneticist R. A. Fisher and others had shown that Mendelian genetics was compatible with the idea of natural selection working on small variations.

“If you think of the 150 years since the publication of ‘Origin of Species,’ it had half that time in the wilderness and half at the center, and even at the center it’s often been not more than marginal,” says Helena Cronin, a philosopher of science at the London School of Economics. “That’s a pretty comprehensive rejection of Darwin.”

Darwin is still far from being fully accepted in sciences outside biology. “People say natural selection is O.K. for human bodies but not for brain or behavior,” Dr. Cronin says. “But making an exception for one species is to deny Darwin’s tenet of understanding all living things. This includes almost the whole of social studies — that’s quite an influential body that’s still rejecting Darwinism.”

The yearning to see purpose in evolution and the doubt that it really applied to people were two nonscientific criteria that led scientists to reject the essence of Darwin’s theory. A third, in terms of group selection, may be people’s tendency to think of themselves as individuals rather than as units of a group. “More and more I’m beginning to think about individualism as our own cultural bias that more or less explains why group selection was rejected so forcefully and why it is still so controversial,” says David Sloan Wilson, a biologist at Binghamton University.

Darwin Or Lose?

Although it may be illegal to teach creationism (whether or not covertly repackaged under names like "intelligent design") as science in public schools in the United States, it appears that most Americans still doubt the truth of Darwin's theory of evolution. As reported in The Economist, only the Turks think less of Darwin. One wonders how countries with such profound skepticism of consensus biological science can hope to compete and survive in the global struggle for economic and cultural survival without radical attitudinal evolution.

Zealous Advocacy For Biodiversity

On our final day, the highlight was meeting with local attorney, Jeff Weiss, who opened the class' eyes to the challenges, complications, and successes of litigating on behalf of biodiversity. My class describes our discussion with Jeff as well as the rest of their last day in paradise:

After lecture this morning, we went to Estate Nazareth to speak with Jeff Weiss, a well-respected attorney popularly known as a “bulldog” for his tenacity. We learned about his efforts to protect the Virgin Islands Tree Boa as well as his part in the Trust for Public Lands’ acquisition of 400+ acres of rainforest near Maho Bay, St. John. Jeff was kind enough to host us at his beautiful home and offered insights into the difficulties, frustrations, and joys that come with biodiversity litigation. Since class lectures were over, we had some free time so we chose to spend it at Magen’s Bay, enjoying the clear green water, the talcum-soft white sand, and beautiful coastal vegetation and tropical fish. We capped off our trip with an excellent dinner, during which we revisited what we had learned about biodiversity science, policy, and law, not to mention how much we hope the law can successfully preserve biodiversity into the future.

A “Little Ditty” authored by Kasey Barton
We will miss our Virgin Islands trip,
Especially Jeff B. James with his witty quip,
And heading out on capt’n Ron’s boat,
Snorkeling with the fish, all afloat.
Learning creative ways to preserve biodiversity made it’s mark,
Thank goodness no one got eaten by a shark!
Widening our short strides to keep up with Torrance,
Here we come, back to good ole Lawrence!

Tomorrow, the class will head back to Lawrence to begin working on their Biodiversity Law papers. Thanks to all of the wonderful local Virgin Islanders (people and creatures alike) who made the fieldtrip such a wonderful experience.

Humpback Whalesongs

Steve Prosterman, who runs the diving program at the University of the Virgin Islands, escorted us out into the wide Caribbean Sea, where he showed us fabulous endangered Elkhorn and Staghorn Coral, and introduced us to the haunting calls of the Humpback Whale. Here's their description:

One of the highlights of the trip occurred today during our third snorkeling trip with Steve Prosterman from the University of the Virgin Islands. We anchored at a reef-friendly buoy, which is part of the buoy system started by Steve in an effort to preserve the remaining coral in the Virgin Islands from needless damage from boat anchors. The law of the Virgin Islands has since been altered to encourage a buoy system. The buoy system helps to preserve biodiversity because the buoys are permanently fixed to the ocean bottom, whereas boat anchors often drag across coral reefs, ripping up the coral as it they do. Steve showed us endangered Elkhorn and Staghorn Coral. We also had the opportunity to dive down about 3-4 meters, and then hear the beautiful songs and calls of wintering Humpback Whales. It was interesting to see the differences in biodiversity between this sight and the previous sights we had snorkeled, which were shallower, warmer, and didn’t have as many different types of fish, coral, crustaceans, molluscs, and other creatures. We topped the night off with a delicious homemade dinner of Falafel, Hummus and Pitas!

Tomorrow - our last day of Biodiversity Law class - we will meet with Jeff Weiss, one the Virgin Islands' best litigators, and a champion of endangered species.

Donkeys, Mongeese, And Rats, Oh My!

The class woke up early this morning, jumped in the Deep Thinker (a fast catamaran), and headed across the Virgin Islands Channel to the British Virgin Islands. As the students explain,

We started the day with a trip to the British Virgin Islands ("BVI") to meet up with Susan Zaluski, who directs the recently-founded Jost Van Dyke Preservation Society. We were struck by how different Jost Van Dyke, one of the smaller, Western BVI, was from St. Thomas. It was much less densly inhabited, with very little noise, traffic, or pollution. Susan talked to us about the Preservation Society’s conservation goals, including controlling the mongoose, donkey, and goat populations, and educating the public about biodiversity and its preservation. We took a boat from Jost Van Dyke to Sandy Cay, a brand-new national park of the BVI, where we took a beautiful hike around this tiny tropical island, and learned about the Preservation Society’s efforts to balance the eccentric horticultural provisions of Laurance Rockefeller's will (for example, the invasive coconut palms must be fertilized once a year, and native termites must be exterminated with pesticide) and the mission of a National Park to preserve biodiversity and the natural beauty of the Cay. We also observed how the eradication of invasive, non-native, rats have allowed the native population of ground skinks to repopulate the Cay. After snorkeling around Sandy Cay, we took the Deep Thinker over to a nearby mangrove-aproned shoreline, where we were able to see starfish, sea urchins, the largest one cell organism, the Pearl of the Sea, octopi, and juvenile coral reef fish (who hide from larger predatory fish amongst the mangrove roots) up close. We were very fortunate to also observe a few Hawksbill or Green Sea Turtles (we're not sure which), who feed on the Turtle Grass found in the bay. We finished up the night with a delicious homemade dinner of Tacos!

Tomorrow we visit the Maclean Marine Laboratory, and then head offshore to a couple of small cays (islands) with thriving endangered Elkhorn and Staghorn coral. Watch for the class' report.

Saving Rainforest On Saint John

Day three of Biodiversity Law began early, checking a live-trapline for Cuban Tree Frogs. Then, we popped over to the island of Saint John to see a huge newly-preserved swatch of rainforest near Maho Bay. The students explain:

We woke up extra early today to meet Renata Platenberg at the top of the trailhead at Magen's Bay to hike down to Magen's Bay Beach. The watershed above Magen's Bay Beach is owned by the Nature Conservancy, which also maintains a trail through the rainforest in that area. We went to observe Renata collecting data on invasive Cuban tree frogs that threaten the native frogs on the island. We found a lot of Cuban tree frogs in the artificial habitats as we descended through different types of rainforest and mangroves down to the beach. We were lucky enough to enjoy a short swim in the clear, clear blue waters before we hopped the ferry to St. John to visit with John Garrison of the Trust for Public Land. John described the recent acquisition of a 420-acre parcel of the island for conservation purposes. The Trust for Public Land used rules of property law cleverly to secure the entire parcel despite the parcel being an undivided interest. The land will ultimately be conveyed
to the National Park Service so that it can become part of the Virgin Islands National Park, which covers over half of St. John. This trip showed us another way of using the law to preserve biodiversity.

Tomorrow we head across The Channel to Britain - The British Virgin Island of Jost Van Dyke - to visit the Jost Van Dyke Preservation Society.

Coral Reef Law 101

The second day of Biodiversity Law centered on a day-long visit to Botany Bay, one of the last large tracts of (mostly) undeveloped land on Saint Thomas. The students report:

First we went to the Botany Bay Estates, a large parcel of privately-owned land closed to the public. We walked around Little St. Thomas, a nature preserve, where we saw a variety of wildlife such as soldier crabs, pelicans, and corals. At Mermaid's Chair we snorkeled(many of us for the first time) and saw numerous species of fish and corals. Particularly exciting was a school of juvenile yellow jacks, which covered the bay floor beneath us and provided plenty of hunting opportunities for the pelicans above. We also found it interesting to see how different types of coral grew on other types, which showed how many species depend on each other. While there we met with Linda Keen, who gave us an idea of the difficulties of managing the proper balance between development and biodiversity conservation. Later in the day we collected samples of leaves from three different locations in order to look at biodiversity at different elevations on the island. We sorted the leaves, then compared and contrasted the species richness, evenness, and diversity at each elevation.

Tomorrow we will do a Cuban Tree Frog census and meet with the Trust for Public Lands on Saint John.

First Day In Paradise

KU Law School's Biodiversity Law class arrived in the Virgin Islands late last night. The first day of the fieldtrip was a revelation to the students. Here is their first nightly eyewitness report:

We awoke to a breathtaking view of Saint Thomas and the Caribbean Sea, probably one of the most spectacular views in the Virgin Islands. We were privileged to attend the inauguration and swearing-in ceremony of the 28th Legislature of the United States Virgin Islands ("USVI") as the invited guests of Senate President, Senator Adlah "Foncie" Donastorg. It was interesting to see the Islanders' pride in their government and their culture. It was also fascinating to see Senator Donastorg, a politician who has championed many biodiversity (and other environmental) issues in the islands.

During the afternoon we visited Dr. Renata Platenberg, a biologist at the USVI Fish and Wildlife Service ("FWS"). She told us about some of the problems the FWS has enforcing biodiversity laws, and showed us a Virgin Islands Tree Boa, a snake whose plight is especially interesting and important to the Virgin Islands. We also learned about Magen's Bay, a gorgeous bay, beach, and watershed that is well managed by a publicly-owned authority, though operated independently from the USVI government. In addition to housing rare mangrove flats and lowland wetlands, Magen's Bay possesses a gorgeous, white sandy beach that is consistently ranked as one of the ten most beautiful in the world.

Adjoining Magen's Bay is a large section of land containing a large diversity of tropical forest trees, other plants, animals, and other organisms. The habitat ranges from mature, native seasonal rainforest species to invasive Royal Palms (originally planted to be part of a botanical garden featuring trees from around the world). This land is protected by a conservation easement held by the Nature Conservancy. Later this week we will have an opportunity to hike through this uniquely diverse, and fortunately protected, habitat.

Tomorrow is our first marine biodiversity survey. Snorkling - WOOO!

Stay tuned for another report tomorrow evening.

A Definition Of Biolaw

In an attempt to have "Biolaw" officially recognized as a "Section" by the American Association of Law Schools ("AALS"), June Carbone, Chris Holman, and I circulated a petition yesterday at the AALS Annual Meetings, in San Diego, to collect signatures in support of a Biolaw Section. AALS rules for Section-creation require a definition of the Section. Here is what we proposed:

Biolaw encompasses both the law of biology and the biology of law. Advances in the biological sciences, such as genetics, biochemistry, cell biology, reproductive biology, evolutionary biology, ecology, neuroscience, and the behavioral sciences, continually challenge both society and the laws that attempt to order, regulate, and protect it. Biolaw combines the use of biological science to describe, analyze, and improve the law with legal analysis of biological science, its institutions, and its implications. Biolaw integrates insights from such biologically-informed research areas as law and genetics, law and neuroscience, reproductive law, behavioral economics, cognitive psychology, law and biotechnology, biotechnology patent law, bioethics, neuroethics, food and drug law, and biodiversity law.

We hope to submit our petition to AALS tomorrow for their decision.

Outrageous advice for female lawyers

I posted earlier about this on Intlawgrrls, but am so offended that I felt the need to repost here. I am amazed that this story has gotten so little coverage. where is the outrage?

According to the Daily Mail, and Marie Claire, the law firm of Freshfields Bruckhaus Deringer has been advising its female associates to "embrace their femininity" by wearing stilettos and skirts to work. This advice is apparently part of its efforts to help its staff "project a professional image in the workplace."

PriceWaterhouse anyone?

Twenty years after the United States found that this kind of gender stereotyping amounted to workplace discrimination, things clearly haven't changed very much. In Price Waterhouse v. Hopkins, United States Supreme Court found that the advice given the Anne Hopkins for how she might make partner, suggesting that she "walk more femininely, talk more femininely, dress more femininely, wear make-up, have her hair styled, and wear jewelry" amounted to unlawful discrimination on the basis of her gender.

Do you think that Freshfields will add this bit of sage fashion advice to the part of its website in which it touts the firm's committment to promoting equality and diversity.

Besides, why limit the advice only to the female associates? Surely male associates will also benefit from the aura of professionalism apparently created through judicious use of stilettos?

AALS Biolaw Section

I thought I would share with the wider Biolaw community an initiative that several of us are taking at the American Association of Law Schools ("AALS"): to have "Biolaw" officially recognized as a "Section", like Intellectual Property and Cyberlaw. Here is the e-mail invitation we sent law professors attending the annual AALS meetings in San Diego:

Biolaw Folks,

June Carbone, Chris Holman, and I have organized a "Biolaw" panel at this year's annual AALS meetings that we hope you will all attend. It will take place on Wednesday, January 7th, from 3:20-4:20 in Laguna, South Tower/Level 1, San Diego Marriott Hotel & Marina.. The panel is entitled The Two Halves of Biolaw (Behavioral Biology and the Law of Biological Innovation), and will feature Dan Burk, Oliver Goodenough, Mark Janis, and Mark Lemley. In addition to our distinguished panel, we will be soliciting signatures from attendees to form an official "Biolaw" section at AALS. The panel is taking place as part of the Socioeconomics program, and June, Chris, and I would like to thank Socioeconomics' support in helping our fledgling attempt to gain AALS section status for Biolaw.

We have also organized an open program on Biolaw that will take place on Friday, January 9th, from 1:30-3:15 in Del Mar, South Tower/Level 3, San Diego Marriott Hotel & Marina. During the open program, we will discuss the creation and organization of the "Biolaw" section.

We believe that biolaw's rapid growth as a field warrants AALS sectionhood. June, Hank Greely, Mark Lemley, Dan Burk, Oliver Goodenough, Mark Janis, and many more of you have long cultivated biolaw as a field, and these efforts have led to much recent activity. For three years now Jim Chen and I have been running the Biolaw: Law and the Life Sciences blog (www.biolaw.blogspot.com) and I've been running the Biolaw listserv (please let me know if you'd like to join). Last year the University of Louisville School of Law held its first biolaw conference, Law and the Life Sciences, and the University of Kansas School of Law just held its second annual Biolaw Conference, Biolaw: Law at the Frontiers of Biology (taped for broadcast on NPR), several weeks ago. In addition, Chris cofounded the IPBiotech listserv, and then founded Holman's Biotech IP Blog (http://holmansbiotechipblog.blogspot.com/). Along with the many contributions you have already made to biolaw, we hope you will support our AALS sectionhood petition.

We hope you are able to attend one or both of these Biolaw events. Thanks for your help moving biolaw forward.

Thank you very much,
June, Chris, and Andrew

Dr. Andrew W. Torrance
Associate Professor of Law
Research Associate, Biodiversity Institute
University of Kansas
torrance@ku.edu
http://www.law.ku.edu/faculty/faculty/torrance.shtml

Wish us luck!

NPR - The New Frontier Of Biolaw

Award-winning NPR health journalist, Bryan Thompson, attended the first day of Biolaw 2.0: Law at the Frontiers of Biology, the second annual Biolaw Conference, held last month at the University of Kansas School of Law. Among others, Biolaw contributors Jim Chen, Rebecca Bratspies, and I spoke. Bryan Thompson produced a story about the Biolaw Conference that included an interview with our opening keynote speaker, Princeton geneticist, Lee Silver, and myself. Listen here to hear the story broadcast this morning on NPR: "The New Frontier Of Biolaw".

The Proposed ESA Consultation Regulations

In August, the Fish & Wildlife Service, along with the National Marine Fisheries Service ("the Services"), proposed a rule amending the Endangered Species Act consultation regulations. As one of several proposed changes to environmental regulations before the end of the Bush administration, this proposed rule seeks to redefine the circumstances in which federal agencies must consult with the Services to determine whether a proposed federal agency action would jeopardize threatened or endangered species. The proposal is, at least in part, an effort to limit the use of the Act as a vehicle for addressing climate change issues following the decision to list the polar bear in May (see here, here, here, and here). But its implications are farther reaching than simply responding to the novel ESA questions posed by climate change.

As documented in comments to the proposed rule (including this one from environmental law professors), the proposed rule may dramtically narrow the scope of consultation through (1) changes to which effects of an action may be considered and (2) exclusions of certain types of actions from consultation.

The proposal would raise the bar on demonstrating effects of an action on listed species by limiting the types of "indirect effects" that may be considered through both an enhanced causal requirement & a high "clear and substantial" informational threshold. In an area often fraught with significant scientific uncertainty and limited information, this bar is an unecessarily high one. Its impact may be to exclude a significant number of proposed federal actions from ESA consultation. The bar is unnecessarily, perhaps unlawfully, high because consultation is merely a process requiring the Services to engage in further analysis on whether imperiled species may face an increased extinction risk due to the proposed action. The process usually ends in the action going forward, but it may include changes to promote viability of a species.

The proposed rule would also exclude several situtations, such as those in which impacts are "not capable of being meaningfully identified or detected in a manner that permits evaluation," from consultation. In so doing, the Services propose to shift significant authority to the action agencies to develop information necessary to show that consultation is required . . . or to fail to develop that information. These action agencies are not the experts on species protection and, instead, often have a large stake in the proposed action. In an area where scientific uncertainty is commonplace, this apparently subtle shift could have singificant impacts on the actual protections afforded listed species.

Along with the effects and potential unlawfulness of the proposed rule (see this article on similar counterpart regulations), it is problematic because it is a transparent effort to entrench a decidely anti-environmental political agenda at the last minute. Not only did the Serivces severely restrict the time period for comments (initially 30 days), but the agencies then sought to review the roughly 200,000 non-form-letter comments it received in an average of seven minutes per comment! The most recent news on the proposal? The final rule is expected any day , akthough it is apparently going to be classified as a "minor" rule that will take effect in 30 (rather than 60) days, which probably explains why it was not released by November 21 as many anticipated. According to The Washington Post, a pre-release draft "goes further than the language . . . issued in August by explicitly excluding climate change from the factors that would trigger an interagency consultation." BNA's environmental reporter (subscription required) has a similar account.

Update: Final Rule Published 12/11.

Winter v NRDC

Without digging too deeply into this case, here are a few thoughts:

Why does the Court take a case like this? The case concerns, at its base, the issue whether the Navy must complete an environmental impact statement under NEPA before undertaking certain training exercises. Although it had initially determined that no EIS was required, the Navy ultimately agreed to complete one. It expected the EIS to be ready in January 2009. In the interim, the district and circuit court imposed mitigation measures on sonar training. The Navy sought to challenge two of those mitigation measures. The Court granted certiorari in June 2008 -- seven months before the issue would likely become moot! (This timeframe is the primary reason that Justice Breyer would not remand the case, according to his concurrence). Last week, approximately two months before the Navy EIS is expected, the Court held that the preliminary injunction upon which the mitigation measures rested is unwarranted.

Perhaps the answer is suggested by the stirking contrast between the characterization of the injuries suffered on the plaintiffs' side. Chief Justice Roberts' majority opinion stresses the distinction between the injury to marine mammals and the injury to human plaintiffs' interests. The Chief Justice states that "even if MFA sonar does cause a limited number of injuries to individual marine mammals, the Navy asserts that plaintiffs have failed to offer evidence of species-level harm that would adversely affect their scientific, recreational, and ecological interests." Thus, the majority opinion weighs an interest in sonar use that is deemed vital to national security against "the possible harm to the ecological, scientific, and recreational interests that are legitimately before this Court." Justice Ginsburg, in contrast, highlights the Navy's own estimate that the planned sonar usage could cause permanent physical damage to nearly 1/2 of the Cuvier's beaked whales in the waters off the west coast, as well as significant harm to other species.

Tying the two threads together, and considering the majority's repeated statements concerning the magnitude of the national security interest, there seems little reason to decide the case other than to emphasize the priority of national security over environmental concerns. While there are certainly significant legal issues surrounding sonar use, what was the important legal issue in this case? Re-affirming the standard for preliminarty injunctions? Noting that NEPA can be suspended from time to time, especially if compliance is acheived as soon as practicable? Maybe I am missing something, but this case strikes me as far more a cultural contest than a legal one. From that perspective, the environmental parties were in a tough spot: sonar probably does cause rather significant harm to beaked whales and perhaps other species (a few highlights are here, here, here, and NRDC's here), but this case seemed like a foregone conclusion once it reached the Supreme Court.

Biolaw 2.0 Conference - Law at the Frontiers of Biology

On November 13th and 14th, 2008, Biolaw 2.0 - Law at the Frontiers of Biology will take place at the University of Kansas School of Law. As the 2.0 suggests, this is the second annual Biolaw Conference. The Biolaw Conference website can be found here.

Professor Lee Silver, world-famous geneticist and public policy scholar at Princeton University, will deliver the keynote address at 1:00 P.M. on November 13th at the Robert J. Dole Institute of Politics. The day's proceedings will be broadcast on National Public Radio affiliate Kansas Public Radio. Professors Jim Chen (Dean, University of Louisville School of Law, and founder of Jurisdynamics), June Carbone (UMKC School of Law), Deven Desai (Thomas Jefferson School of Law), and I, Andrew Torrance (University of Kansas School of Law) will respond to Professor Silver's address, which is entitled The Clash of Biotechnology and Religion. Professor Peter Yu (Drake University School of Law) will conclude the first day of Biolaw 2.0 with his talk, A Mishmash of Two Transplants, which address the difficulties of applying intellectual property law from one country to other countries.

The second day of Biolaw 2.0 will feature talks on a variety of bleeding-edge biolegal subjects. Here is the schedule:

Deep Six – 8:00-9:00 am
Dean Jim Chen, University of Louisville Louis D. Brandeis.School of Law

GM Food and the Challenge of Environmental Sustainability – 9:00 -10:00 am
Professor Rebecca Bratspies, CUNY School of Law

Patents and Biotechnology – 10:15-11:15 am
Professor David Schwartz, John Marshall School of Law

Synthesizing a Legal Approach to Synthetic Biology — 11:15- 12:15
Professor Andrew Torrance, University of Kansas School of Law

Black Markets for Human Body Parts – 1:00-2:00 pm (Lunchtime Keynote Address)
Professor Michelle Goodwin, University of Minnesota Law School

Public Institutions Role in the Biomedical Research Commons – 2:00 – 3:00 pm
Professor Peter Lee, UC Davis School of Law

Legal Impediments to the Growth of Life Sciences in the Economy – 3:15 - 4:15 pm
Patrick Wooley and colleagues, Polsinelli Shalton Flanigan Suelthaus

Innovation Impeded? Human Gene Patents – 4:15 - 5:15 pm
Professor Chris Holman, UMKC School of Law

The Biolaw Conference is to promote progress in biolaw as a vital field of law. This year's conference has grown substantially from last year's inaugural event. Our intention is make the Biolaw Conference a permanent annual event that highlights the best in biolaw scholarship.

Stimulate Green Energy

"[W]hen we eat from the industrial-food system, we are eating oil and spewing greenhouse gases," writes Michael Pollen in the lead article of the New York Times' food issue. Rising food prices, he argues, cannot be addressed until we address core features of our food production. Among them are the basic energy and environmental issues surrounding industrial argriculture.

At the same time, we are in the midst of a very tumultuous economic situation. The immediate crisis -- the credit crisis, the swinging stock market -- may abate, but there is looming recessionary concern and little hope for immediate housing price stabilization.

Agriculture and economic growth are but two of the fundemental issues connected with our energy system. The web of issues -- and thus our nation -- could benefit tremendously from a major federal green-energy initiative. Government supported green infrastructure projects would immediately create jobs and a more inviting environment for business investment in new energy projects or technology as a bridge to a longer-lasting and more penetrating green energy economy. Development of more environment-friendly food production techniques is a component of the green energy economy and should also be supported in such initiatives.

Such a stimulus could address large pieces of many of the country's most pressing problems: greenhouse gas emissions, national security concerns based on forgein oil dependence, trade (in domestic technology), food security (by promoting long-term energy stability and affordability), and economic security.

If we are in for a bumpy economic ride, as it seems we are, government actions aimed at addressing it can also aim toward sending us in the right direction hereafter. My suggestion is to start with energy. It demands the sort of infrastructure investment that can produce short-term economic activity. In the current economic environment, that investment is only likely from governement, and the backing must be strong to have a significant impact.

Large-scale government initiatives in green energy techonolgies will encourage the kind of investment that can pay long-term national dividends. And they have a necessary role in sustaining a livable planet in the face of climate change.

Strobe Lights The Way

Last night I attended the 2008 International Relations Council annual awards banquet in Kansas City. Strobe Talbot received the award for international statesmanship. He then went on to deliver a speech that began with Socrates' concept of world citizenship and ended with global climate change. Talbot's main message was that international institutions undergird world peace, and that successfully meeting the greatest current challenge to international peace - global climate change - will require an international legal regime that accomplishes at least some rudimentary level of world government.

Drawing from his new book, The Great Experiment: The Story of Ancient Empires, Modern States, and the Quest for a Global Nation, Talbot traced the history of international treaties and institutions as responses to, and prophylactics against, armed conflicts among countries, empires, and cultures. Beginning with Socrates' claim to have been "a citizen of the world", the President of the Brookings Institute went on to offer a magisterial overview of how international law tends to encourage good international relations, encouraging peace and prosperity. Talbot identified global climate change as the single greatest threat to humanity's future, and suggested that treaties and other international institutions will need to bind nations together if the world is to avoid the worst consequences of greenhouse gas emissions.

One world government is an infamous bogeyman of American politics. Many in the United States believe in, and fear, the fabled "Black Helicopters". Strobe Talbot made a strong case for the proposition that the real fear humanity should have is that countries will continue to confront global climate change independently - an approach apparently favored by Talbot's cousin, George Bush II - rather than as a single coordinated polity forged by international legal institutions.

A free hiking guide

Yes, this is an advertisement for a one-year subscription to Backpacker magazine. But it comes with a nice, free offer: a 48-page .pdf file providing nice information on some of the country's best hiking opportunities.

Happy trails to BioLaw's readers.