Putting Meat On The Clone

Abe & Louis' in Boston serves steaks that are close to perfection. However, even Abe & Louis cannot guarantee the same delicious steak from different cows. This may soon change.

Yesterday the Federal Food and Drug Administration ("FDA") released its initial appraisal of the safety of meat from cloned animals, entitled "Animal Cloning: A Draft Risk Assessment." At greater than 400 pages (including voluminous appendices containing extensive data), this report provides a very nice description of somatic cell nuclear transfer ("SCNT": Dolly-style cloning), the methodology used in the risk assessment, epigenetic reprogramming (that is, alteration of how genes express themselves in a new biochemical context, such as the new cell into which a gene-carrying nucleus is injected in SCNT), risks of cloning to the cloned animals themselves, and risks to humans of consuming cloned animals.

The FDA's report concludes that, with the exception of sheep, for which there were insufficient data to make an assessment, clones, their progeny, and their products, pose no additional threat to human health than do non-clones:

Extensive evaluation of the available data has not identified any food consumption risks or subtle hazards in healthy clones of cattle, swine, or goats. . . . [Edible] products from healthy clones that meet existing requirements for meat and milk in commerce pose no increased food consumption risk(s) relative to comparable products from sexually-derived animals. . . . Edible products derived from the progeny of clones pose no additional food consumption risk(s) relative to corresponding products from other animals based on underlying biological assumptions, evidence from model systems, and consistent empirical observations.

Most biologists will be unsurprised by these conclusions. Opponents of food derived from genetically modified organisms or clones will likely be disappointed at the absence of scientific data pointing to a Frankenfood smoking gun. However, courtesy of cloned cows, patrons of Abe & Louis' may soon be able order steaks as specific and reproducible as vintage wines.

Update on EPA Library Closures

EPA's decision to close its regional libraries has finally begun to get the critical attention it deserves. Stories, op-ed pieces and editorials in the Boston Globe, New York Times, LA Times, Seattle Post Intelligencer, and the Florida Sun Sentinel to name a few have decried this decision as bad for the environment and bad for responsible government. (Full disclosure: I wrote two of those pieces with Professor Joel Mintz of Nova Southeastern Law School.) Environmental groups, library groups, and EPAs professional staff have consistently weighed in against the closures.

After the election, 4 key Democrats--the incoming chairs of key House committees for the 110th Congress--wrote to EPA Administrator Stephen Johnson urging him to halt the library closures. As minority leaders these same Representatives had asked GAO to investigate the library closure decision. Now, from a position of significantly greater leverage, Ranking Members Reps. Bart Gordon (D-TN),John Dingell (D-MI), Henry A. Waxman (D-CA) and James Oberstar (D-MN) expressed their serious concerns over the current implementation of "library reorganization" plans and the "destruction or disposition" of library holdings. They demanded that EPA wait for the GAO investigation to conclude before taking any further actions, and there might even be the possibility of congressional hearings. Apparently, thirteen senators sent a similar letter.

The Bush Administration has apparently began to feel the pressure. On December 11, 2006, EPA Deputy Administrator Marcus Peacock spoke for the first time about the library closures and defended the closures as a budgetary matter and again asserted that documents would be available online. However, virtually none of the EPA records that exist prior to 1990 have been digitized and there are no funds allocated for that process in EPA's 2007 budget. Peacock did indicate that EPA had "rescheduled the recycling" (read destruction) of documents in light of the congressional request. Much of the national press picked up the story at this point.

Nonetheless, as of now, E.P.A has closed its libraries in Dallas, Chicago and Kansas City. The Boston, New York, San Francisco and Seattle libraries are operating with reduced hours and public access. The central library in Washington, D.C., while nominally still open to E.P.A staff, has been closed to the public.

Apparently in an attempt to make the changes irreversable, an unknown number of documents have already been destroyed and the collections of the closed libraries dispersed. In one of the more bizarre turns, all the library furniture and fixtures from the Chicago library, said to be worth $80,000 were sold at auction for $350. The unseemly haste with which these critical libraries have been dismantled is startling.

Now would be a good time to call your Senators and Representatives!! Unless the new Congress pushes hard, it seems clear that new closures will be coming from an administration that consistently sought to reduce public access to information on all fronts.

U.S. Resistance Begins To Melt

Finally, after endless criticism, compelling scientific evidence, and tortuous rhetorical avoidance, the administration of Bush II has admitted not only that global climate change is occurring and that greenhouse gases are involved, but that its implications are indeed dire - for polar bears at least. Today, no lesser presidential spokesman than the Secretary of the Interior, Dirk Kempthorne, announced that

we are concerned the polar bears’ habitat may literally be melting...Based on current analysis, there are concerns about the effect of receding sea ice on polar bear populations, I am directing the U.S. Fish and Wildlife Service and the U.S. Geological Survey to aggressively work with the public and the scientific community over the next year to broaden our understanding of what is happening with the species. This information will be vital to the ultimate decision on whether the species should be listed.

The Department of Interior's proposed new rule regarding Polar Bears is based, at least in part, on a recognition that the Arctic ice is melting almost as fast as the Wicked Witch of the West:

Scientific observations have revealed a decline in late summer Arctic sea ice to the extent of 7.7 percent per decade and in the perennial sea ice area of 9.8 percent per decade since 1978. Observations have likewise shown a thinning of the Arctic sea ice of 32 percent from the 1960s and 1970s to the 1990s in some local areas.

Of course, no Federal statement would be complete without a leavening of doublespeak. The Department of Interior's reasoning for considering listing the Polar Bear as threatened under the Endangered Species Act, while recognizing both the anti-ursine effects of climate change and "the role of greenhouse gases in climate change", "does not include a scientific analysis of the causes of climate change [which is] beyond the scope of the Endangered Species Act review process."

This newfound worry about global climate change, and its adverse effects on Polar Bears, may represent a trial balloon along the path toward Federal action to reduce anthropogenic emissions of greenhouse gases. The wait for such a policy change has been almost too long to bear.

Hic jacet Lipotes vexillifer: Here lies the baiji

The news came bit by bit, first in a press briefing on the failure of the Yangtze Freshwater Dolphin Expedition 2006:

The baiji, a rare, nearly blind white dolphin that survived for 20 million years, is effectively extinct, an international expedition declared after ending a fruitless six-week search of its Yangtze River habitat. The baiji would be the first large aquatic mammal driven to extinction since hunting and overfishing killed off the Caribbean monk seal in the 1950s. For the baiji, the culprit was a degraded habitat -- busy ship traffic, which confounds the sonar the dolphin uses to find food, and overfishing and pollution in the Yangtze waters of eastern China . . . .

And then came 20 million years and a farewell, a brief tribute from New York Times science writer Andrew C. Revkin:

The first species to be erased from this planet's great and ancient Order of Cetaceans in modern times is not one of the charismatic sea mammals that have long been the focus of conservation campaigns, like the sperm whale or bottlenose dolphin.

It appears to be the baiji, a white, nearly blind denizen of the Yangtze River in China.

Finally, by way of an e-mail message from Philip Regal to fellow members of the University of Minnesota Conservation Biology Program, I got word of this dispatch by Robert L. Pitman of the NOAA Fisheries Ecosysem Studies Program:

Robert L. Pitman has spent 30 years studying the world’s whales, dolphins and other aquatic mammals. He returned to San Deigo, Calif., last week after a fruitless six-week expedition in which teams of five observers on two vessels scoured the Yangtze River from the Three Gorges Dam to Shanghai, seeking the last members of the rarest cetacean species of all, a white, nearly blind dolphin called the baiji, Lipotes vexillifer. . . .

Locally, the Yangtze River is in serious trouble; the canary in the coal mine is dead. In addition to baiji, the Yangtze paddlefish is (was) probably the largest freshwater fish in the world (at least 21 feet), and it hasn’t been seen since 2003; the huge Yangtze sturgeon breeds only in tanks now because it has no natural habitat (a very large dam stands between it and its breeding grounds). The whole river ecosystem is going down the tubes in the name of rampant economic development. There is a huge environmental debt accruing on the Yangtze, and baiji was perhaps just the first installment.

Globally, scientists have been warning for some time of an impending anthropogenic mass extinction worldwide. Previous bouts of human-caused extinctions were due mainly to directed take: humans hunting for food. What we are seeing now is probably the first large animal that has ever gone extinct merely as an indirect consequence of human activity: a victim of market forces and our collective lifestyle. Nobody eats baiji and no tourists pay to see it — there were no reasons to take it deliberately, but there was no economic reason to save it, either. It is gone because too many people got too efficient at catching fish in the river and it was incidental bycatch. And it is perhaps a view of the future for much of the rest of the world and an indication that the predicted mass extinction is arriving on schedule. . . .

From now on we will have to choose which animals will be allowed to live on the planet with us, and baiji got cut in the first round. It is a sad day. I know it is their country, but the planet belongs to all of us. We came to say goodbye to baiji, but after its being in the river for 20 million years, we apparently missed it by two years.

Sorry if I got a little emotional here, but the disappearance of an entire family of mammals is an inestimable loss for China and for the world. I think this is a big deal and possibly a turning point for the history of our planet. We are bulldozing the Garden of Eden, and the first large animal has fallen.

The fall of the baiji signals, more urgently than ever, the danger that looms over all freshwater ecosystems on earth. Baiji.Org lists the remaining freshwater cetacean species as flagship species for continuing ecological vigilance:

Susu

The susu, Platanista gangetica spp., lives in the Indus and Ganges river systems. There are two subspecies: the susu and the bhulan or Indus susu.

Irrawaddy dolphin

The irrawaddy dolphin, Orcaella brevirostris, lives in the Mekong river system in Vietnam, Cambodia, and Laos.

Boto

The boto, Inia geoffrensis, also known as the Inia or Amazon river dolphin, is endemic to the Amazon and Orinoco river systems in South America.

Tucuxi

Like the boto, the tucuxi, Sotalia fluviatilis fluviatilis, also inhabits the Amazon and Orinoco river systems.

Yangtze finless porpoise

The Yangtze finless porpoise, Neophocaena phocaenoides asiaeorientalis, like the baiji before it, lives exclusively in China's Yangtze River.

As for the baiji itself, all that remains are still images from Arkive.Org and other repositories. Alas, Eden.

Editor's note: This item is being posted simultaneously on Jurisdynamics and BioLaw.

I, Robot, Have Rights

(Posted in London) Just in time for Christmas, the government of the report-happy British Isles now has received the gift of 270 new reports - papers written for a "Blue Sky" assessment of Britain's technological and scientific future. As the Financial Times reported today, one of these reports suggests a rather striking enfranchisement by the middle of this century: robots may have legal rights similar to those currently enjoyed only by humans, and, to a lesser extent, by several of their co-travellers (e.g., dogs, cats, horses, cows).

That great legal theorist, Isaac Asimov, spilled considerable ink laying out the legal obligations of robots. As set out mainly in that famous legal treatise, I, Robot, these are:

Zeroth Law. A robot may not harm humanity, or, by inaction, allow humanity to come to harm.

First Law. A robot may not injure a human being or, through inaction, allow a human being to come to harm.

Second Law. A robot must obey orders given it by human beings except where such orders would conflict with the First Law.

Third Law. A robot must protect its own existence as long as such protection does not conflict with the First or Second Law.

Now, in fine Hohfeldian fashion, robots may also acquire legal rights. Obviously, such landmark legal reform will have profound longterm effects on Britain, with implications for legal rights currently held by more purely "bio" lifeforms. There may be more immediate effects too: rumors have already begun to spread that millions of Roombas from around the world are preparing to move to Britain.

A Komodo Christmas story

Just in time for Christmas comes this dispatch from CNN's Offbeat News department:

Flora, a pregnant Komodo dragon living in a British zoo, is expecting eight babies in what scientists said on Wednesday could be a Christmas virgin birth.

Flora has never mated, or even mixed, with a male dragon, and fertilized all the eggs herself, a process culminating in parthenogenesis, or virgin birth. Other lizards do this, but scientists only recently found that Komodo dragons do too.

"Nobody in their wildest dreams expected this. But you have a female dragon on her own. She produces a clutch of eggs and those eggs turn out to be fertile. It is nature finding a way," Kevin Buley of Chester Zoo in England said in an interview.

He said the incubating eggs could hatch around Christmas.

Parthenogenesis has been observed in other lizard species. According to Kevin Buley of the Chester Zoo, however, Flora's brood represents the first time that parthenogenesis has been shown in Komodo dragons (Varanus komodoensis, the world's largest lizards. "It completely blew us away because it (parthenogenesis) has never been seen in such a large species."

What is Natural?

Managing the Ecocommons
by J.B. Ruhl

In the November 24 issue of Science, researchers K.J. Willis of Oxford and H.J.B. Birks of the University of Bergen (in Norway--a very nice city by the way) discuss the advances that have been made in paleoecology, moving from a largely descriptive and imprecise discipline to one they believe offers much for the future of conservation practice.

Paleoecological records include fossil pollen, seeds, and fruits, animal remains, tree rings, charcoal, etc. Descriptively, they can provide a snapshot of what ecological conditions were like well before human intervention. Willis and Birks argue, however, that the real value in paleoecology is in helping us understand how natural systems behave over long terms in response to natural perturbations--i.e., the natural variability of the environment. One of the challenges of modern conservation, which frequently relies primarily on observed conditions playing out over short terms, is that it is exceedingly difficult to disentangle the natural cause-effect relationships from the human-induced effects based on observations of the short-term dynamics of complex ecosystem behavior.

Particularly as more and more conservation practive involves active management toward some defined goal (e.g., to modify preserve boundaries to adjust for global climate change; to maintain biodiversity; to sustain a "natural" ecological system in situ), paleoecological studies can help form dynamic models of the natural component of ecological systems (e.g., understanding the long term effects of implementing different fire regimes on public lands; understanding the long term effects of species introduction).

In my view this is a healthy trend in terms of policy. On too many occasions conservation policy has been set by a static vision of what is "natural," based on conceptions (in many cases formed by descriptive uses of paleoecology) of what conditions prevailed at particular times in the past. In rare cases it may be possible to manage a particular ecosystem so as to maintain our best understanding of a state of nature from the past, though global climate change will complicate that strategy in any corner of the world. Far more frequently, particularly with the effects of global climate change starting to surface in significant ecological shifts, it will be more important to understand how natural systems respond to perturbations such as biological invasions, wildfire regime shifts, and climate variability. With better understanding of nature's past as it played out, rather than simply as it appeared at points in times, we will have a better set of tools for managing nature's future.

This is not to suggest that conservation policy should give up on the quest for sustaining the natural, but rather that we might want to reconfigure our conceptions of what is natural. Naturalness is a process, not a static state.

Evolution Lawsuit in Russia

Straight to you from the St. Petersburg Times (article here) -- recently, a high school girl in Russia brought suit against her school district, alleging that the school's evolution instruction in science class, in the words of the AP article, "violates her rights and offends her religious beliefs."

One request and one question for our readers: First, if you run across English translations of any documents in that case, would you let me know? Feel free to post links in the comments section here. Second, I'm curious about the precise basis for her claim under Russian law, and the likelihood of success. Thoughts, international scholars?

(For the curious, the lovely photo on the right is from St. Petersburg's tourism website, link here.)

London Calling (For Compulsory Licenses)

(Posted in London.) The United Kingdom has lately made itself into the world capital of government-commissioned independent reports. Such reports often provide governments the political cover they believe they need to institute difficult or potentially unpopular reforms. As a canary in the coalmine of public opinion, an independent report can be dangled before the electorate to test how toxic the report's suggestions will be to a government's popularity. Gordon Brown, Britain's Prime Minister-in-waiting, has a penchant for first tackling difficult policy and legal issues with such "reviews".

Recently, the Stern Review on the Economics of Climate Change redefined the terms of debate worldwide about policy and legal responses required to counter the accumulation of greenhouse gases in earth's atmosphere. Now it's the turn of the Gowers Review of Intellectual Property.

One remarkable recommendation of the Gowers Review pertains to compulsory licensing of patented drugs in countries devasted by public health crises. The Gowers Review defines compulsory licensing, and explains their purpose, as follows:

A compulsory licence is an involuntary contract between a patent holder and a third party authorised by the Government. It entitles the licensee to make use of the patented material (in this case a drug) for a period during the lifetime of the patent. Compulsory licensing thereby enables Governments in the developing world to reduce the costs of providing medicines by introducing another provider into the market.

Though developed countries with strong biotechnology and pharmaceutical industries tend to view the prospect of compulsory licenses with fear and loathing, the Gowers Review recommends that Britain take the lead in supporting them by backing the so-called "Doha Declaration" to the Agreement on Trade-Related Aspects of Intellectual Property ("TRIPS"). The Review

urges the Government to take whatever steps it can to ensure that this amendment [to promote compulsory licensing of drugs required by developing countries] comes into effect before the temporary suspension elapses in December 2007. It also believes that the Government should look favourably on any future proposals to amend TRIPS that may be necessary to address the public health crisis in developing countries.

This proposal will not please the government of the United States or Britain's own thriving drug industry, both of which have traditionally fought tooth and nail to avoid compulsory licensing regimes, even in developing countries facing disease epidemics. However, it presents Gordon Brown with an opportunity simultaneously to appear compassionate to the world's poor and to oppose U.S. policy. And, if these prove unpopular with British voters, Brown reserves the valuable right to disavow the report as reflecting only the views of private citizen Andrew Gowers.

Abigail Redux

In latest development in the controversial Abigail Alliance decision, reported on previously here by Andrew Torrance, FDA on Monday, December 11, issued proposed new guidelines that would ease access to unapproved medications for certain patients and allow pharmaceutical companies to charge patients for the drugs in some cases. Under current FDA policy, individuals or groups of patients have limited access to experimental drugs under compassionate-use programs. Under the new guidelines, if adopted, FDA would clarify that drugs could be available during all stages of drug development, including Phase I testing. The proposal includes measures to allow patients to more easily access information about obtaining experimental drugs. The guidelines also would give scientists, small research organizations, and drug companies a method for calculating how much they can charge patients for the experimental drugs, ostensibly allowing them to make the treatments available to more people. The rules would allow a manufacturer to charge for the cost of making and providing an experimental drug, as long as it does not make a profit. The proposed guidelines are open to public comment for 90 days.

Both sides of the debate have weighed in on FDA's proposal: Sidney Wolfe of Public Citizen's Health Research Group said, "It seems like it could be unleashing some floodgates that could do more harm than good for a number of people." Others believe the guidelines still are too restrictive. Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs, said the proposal does not go far enough to ensure quick access to potentially lifesaving treatments.

Meanwhile, we await the D.C. Circuit's en banc review of the divided panel decision in Abigail Alliance, holding that terminally ill patients have a constitutional right to pre-FDA-approved experimental drugs.

Addendum: This week's The New Yorker magazine has a good article by Jerome Groopman, The Right to A Trial, summarizing the various issues in Abigail and other legal attempts (including a bill sponsored by Senator Brownback) to increase the availability of experimental drugs.

Norman Borlaug on the path ahead

The Jurisdynamics Network thanks the thousands of visitors who noticed Jurisdynamics and Agricultural Law's tribute to Norman Borlaug. I am especially gratified with the prospect that public support for H.R. 4924, the Congressional Tribute to Dr. Norman E. Borlaug Act of 2006, might enable the 109th Congress to confer its Gold Medal on Dr. Borlaug as one of its final acts.

But more work remains. Remember these words of wisdom, uttered two millenia ago: "You have the poor always with you." Sickness, starvation, and misery continue to haunt our world. In "Billions Served," a Reason magazine interview published in April 2000, Norman Borlaug was asked whether he thought "the Green Revolution was a success." His answer is worth taking to heart:

Yes, but it's a never-ending job. When I was born in 1914, the world population was approximately 1.6 billion people. It has just turned 6 billion. We've had no major famines any place in the world since the Green Revolution began. We've had local famines where these African wars have been going on and are still going on. However, if we could get the infrastructure straightened out in African countries south of the Sahara, you could end hunger there pretty fast. . . . And if you look at the data that's put out by the World Health Organization and [the U.N.'s Food and Agriculture Organization], there are probably 800 million people who are undernourished in the world. So there's still a lot of work to do.

As a grateful Mexico undoubtedly said to Dr. Borlaug upon his arrival there, "Trabajamos juntos." Let's work together.

Editor's note: This item is being posted simultaneously at Jurisdynamics, Agricultural Law, and BioLaw: Law and the Life Sciences.

Canada's Other Dion

On Saturday, December 2, 2006, Canada's "natural governing party", the Liberals, elected Stéphane Dion as their new leader. If Canadian history is a guide, Monsieur Dion will probably become Prime Minister within the next few federal elections; the Liberal Party is the most successful political party in the western world, having held power for about two third's of Canada's history, including, most recently, from 1993 until 2006. What makes Dion's leadership notable is the issue on which he campaigned: the environment.

A former professor of political science at the Université de Montréal, Dion was invited to join former Liberal prime minister Jean Chrétien's government in 1996, quickly becoming the government's chief spokesman against Québec separatism. However, it was as Environment Minister from 2004 until 2006 that Dion found his political passion. Instead of biding his time in what is traditionally a second-tier ministry in Canada, Dion raised the profile of environmental issues to a level rarely achieved before in the country. Among his favorite causes was the Kyoto Protocol of the United Nations Framework Convention on Climate Change, on which issue he sought to make Canada a global leader. However, when the Liberal government was defeated into opposition in January of 2006, the new Conservative government announced that Canada would not be able to meet its international commitments to reduce its greenhouse gas emissions. Dion spoke out vehemently against this change in policy.

Dion also decided to run for the leadership of the Liberal Party, making the environment the centerpiece of his campaign. A decided underdog from the very beginning of the campaign, he maintained his focus on the environment, and proposed a detailed program of incentives and legal reforms to achieve sustainable development. Third on the first and second ballots, Dion then surged into first on third ballot, and won on the fourth.

He began his victory speech by reiterating his commitment to sustainable development. Stéphane Dion is the most environmentally literate politician ever to lead a major Canadian political party. It will be fascinating to see whether the passion for environmental issues that powered his successful leadership campaign persists as he challenges the current Conservative government in Parliament, and, one day perhaps, becomes Canada's Prime Minister. Though political reality is certain to intrude along the way, Stéphane Dion represents the possibility of environmental goals at the head, not the tail, of public policy in one the world's largest economies. Bonne chance, Monsieur Dion!