GE Eucalyptus Experiments in the Southern US

USDA has approved plantings of genetically engineered eucalyptus tress at sites in seven states. Center for Biological Diversity and other organizations are suing to set aside the approval.

Eucalyptus is a fast-growing tree that dominates tropical timber plantations. It is not native to the U.S. and has become invasive in some places.

Two major international timber companies, International Paper and MedWestvaco, have formed ArborGen to test eucalyptus that has been engineered for cold-tolerance and other traits in the southern U.S.

There are a number of potential benefits, particularly for the timber industry. However, the CBD suit alleges that USDA did not fully evaluate the risk of the introduced species becoming invasive along with other potential negative environmental consequences. Projects to selectively breed eucalyptus for use in the U.S. have been underway for some time, but the introduction of engineered genes could pose unique risks for impacts on surrounding species and ecosystems.

Additional discussion is available here, here, and here.

Long-Term Biodiversity Impacts of the Gulf Oil Spill

The Deepwater Horizon Oil Spill's impacts on biodiversity are sure to go beyond harm to the charismatic mega-fauna featured in front-page photographs. A much longer term threat exists in regard to impacts on lower levels of the food chain. The extent of future impacts remains uncertain, but may be closely linked with the extensive use of dispersants.

These chemicals spread the oil below the surface, making it much less visible and reducing the immediate economic impact. They could potentially also reduce BP's liability, not only by limiting immediate economic impact but also by inhibiting accurate estimates of the volume of oil spilled. At the same time, dispersing the oil deep below the surface could have major negative impacts on micro-organisms and other less well-known organisms essential for the functioning of the ecosystem. Are we avoiding short-term costs by imposing much greater and longer-term impacts on the biodiversity of the Gulf?

A good piece on tonight's PBS Newshour raises some of these questions, while detailed information on Gulf biodiversity and impacts from the spill is available here, among other places, and current fish & wildlife reports are available here.

The New EU Mandatory Organic Label

As of July 1, new regulations came into effect that require the use of the European organic logo on pre-packaged organic food and beverage products. The European Commission states that the new logo is designed to provide a consumer with “complete confidence” that the goods they purchase are produced in line with EU organic farming regulations.

The logo is made up of 12 stars in the shape of a leaf. According to FOODnavigator.com

[w]here used, the logo must be accompanied by an indication of the place where the agricultural raw materials were farmed, stating that raw materials originate from 'EU Agriculture', 'non-EU Agriculture' or 'EU/non-EU Agriculture'. If all raw materials have been farmed in only one country, the name of this specific country, in or outside the EU, can be indicated instead. National, region, or private labels will be allowed to appear on packaging alongside the common EU logo. Under the EU’s new regulations, products can only be labelled as organic if:

• At least 95 per cent of the product's ingredients of agricultural origin have been organically produced;
• The product complies with the rules of the official inspection scheme;
• The product has come directly from the producer or preparer in a sealed package;
• The product bears the name of the producer, the preparer or vendor and the name or code of the inspection body
• The product does not contain GMOs

The new EU rules also set out conditions for organic aquaculture production of fish, shellfish and seaweed. These specify that biodiversity should be respected, and do not allow the use of induced spawning by artificial hormones.

Climate Change & Human Health

Biolaw readers may find the National Institute of Environmental Health Sciences recent publication, A Human Health Perspective on Climate Change, noteworthy. It provides an accessible discussion of existing knowledge and research needs pertaining the strikingly wide array of health impacts related to climate change, organized into 11 broad topics. Greater awareness of the probable direct impacts of climate change on human health in the U.S. could go a long way toward raising the public's perception of climate change as an important policy issue.

Exotic game, lethal invaders

The Florida Fish and Wildlife Conservation Commission has declared special hunting season on reptilian species of environmental concern: Burmese python, Indian python, reticulated python, northern and southern African rock python, amethystine or scrub python, green anaconda, and Nile monitor lizard. Hunters may take these species throughout state lands in southern Florida from March 8 through April 17, 2010.

The accompanying Miami Herald video portrays Bob Hill, who hunts pythons and other invasive reptiles in the Everglades for the South Florida Water Management District. The New York Times has hosted a forum on the use of hunting as one weapon against alien invasive species.

Editor's note: Cross-posted at Jurisdynamics.

Top 50 biotech blogs

The Jurisdynamics Network is pleased that the Medicareer blog has listed both Agricultural Law and Biolaw among the top 50 biotech blogs. And now Biolaw has been named one of the 50 best blogs for biotech students.

Asian Carp

Asian carp in the Illinois River and other waters west of the Great Lakes are becoming infamous invasive species and threatening to wreak havoc on the Great Leaks ecosystems if they cross an electric barrier meant to block them from Lake Michigan. Some species grow to over 100 lbs., while others have become notorious in popular media for their quantity and jumping into and over boats.

The carp are also the subject of a multi-state effort to persuade the U.S. Supreme Court to re-open the 1929 case Wisconsin v. Illinois. In that case, the Court ruled against Illinois' excessive water withdrawal but retained jurisdiction as Illinois worked to find alternatives. The case was reopened several times, including as recently as 1980.

The current controversy is over the option of closing the canal and locks connecting Chicago area rivers to Lake Michigan as a means of prevent the carp from entering the Lakes. Michigan unsuccessfully requested an injunction from the U.S. Supreme Court to close the locks, and the Obama Administration has just released a new Asian Carp control plan that opts not to close off the connection. Instead, the plan relies on an electric barricade and targeted efforts to kill the fish closest to the lake.

The effort to reopen the Wisconsin v. Illinois case, joined by several lake states (most recently Indiana) is pending before the U.S. Supreme Court. Michigan Attorney General Mike Cox initiated a project seeking to organize public pressure on the Obama administration to close the Illinois River connection to Lake Michigan, and has been joined by Indiana, Ohio, Pennsylvania, and Wisconsin.

The interests driving the controversy are partly economic -- lake states fear lost jobs and revenues if the carp enter the Great Lakes, while closing the locks would have major economic implications for shipping in the Chicago area -- but there is also a major environmental risk if the carp make the crossing into Lake Michigan. For that reason, this issue calls out for a precautionary approach: the locks should be temporarily closed as the effectiveness of other methods is determined.

More broadly, the Asian carp situation highlights the need for a more comprehensive and consistent legal mechanism to address invasive species. The problem will only become worse, and the current ad hoc approach leaves the response to each arising problem dependent on the direction of the political winds.

Biodiversity Law 2010 - Virgin Islands National Park

Today was downhill all the way. The class hiked Saint John from mountaintop to seashore. Here is how the University of Kansas School of Law Biodiversity Law class describes the highs and lows:

Today we went to St. John by ferryboat. Our mission: to hike reef bay trail. Reef bay trail begins on the highest point in the Virgin Island National Park. We descended the mountain with a Unites States National Park Service Ranger, Don Near. Ranger Don is the most experienced Ranger in the Virgin Islands and has a wealth of knowledge about the National Park. As we began the descent, we noticed that the air was cool, the trees were tall and thin, and there was less under brush. We walked down an old Danish cart trail. Toward the bottom, the forest was denuded, probably from goats. However, this forest was recovering from overgrazing as evidenced by the abundance of saplings. While the canopy was lower at the bottom, there was more vegetation at the ground, including wild pineapple, cactus, and epiphytes.

We observed a lot of native as well as several of invasive species that did not appear to be disturbing the endemic vegetation. The invasive species included the wild pineapple, sweet lime and strangler fig. The native species included the turpentine, the Virgin Island Palms, and cinnamon tree. The National Park also contained an abundance of animal life, both native and introduced. The only natural mammals on the island are bats. However, we also observed a mongoose, deer, and evidence of overgrazing by goats. We also saw large spiders, snails, soldier crabs and lizards.

Due to the presence of the National Park, there is a noticeable difference between St. Johns and St. Thomas. St. Thomas is much more developed than St. Johns and much more people live on St. Thomas than St. Johns. The development leads to vastly different coastlines. In St. Johns the trees go to the ocean, while on St. Thomas, the tree-line begins after expanses of beaches, shops, ports, streets, and parking lots. Due to the lack of development, St. Johns supports a denser and richer population of wildlife.

While there are many biodiversity laws in force that protect the Virgin Islands National Park, enforcement is a problem because of local culture, jurisdictional issues, and financial constraints. One example of the limitation of local culture is that the local population can fish on the waters of the National Park, but they are only allowed to take two specific species. The other fish species are protected as endangered species by the Endangered Species Act. While the natives know of this rule, they take more than they are supposed to without fear of enforcement. The lack of enforcement undermines the ESA as well as other environmental laws. Another example comes from the land mammals. Donkeys are grazers and eat endangered plants thereby impacting the entire forest ecosystem. The local human population finds the donkeys useful and the idea of slaughtering them unsavory. Additionally, cats eat endangered lizards and birds, but the local population fights against any harmful removal efforts based on sympathy.

Jurisdictional issues in the National Park also undermine the enforcement of biodiversity laws. When an offense is committed in the Park, sometimes it is unclear whether the National Park Service or the Virgin Island’s local police has jurisdiction. This confusion leads offenses being overlooked and locals not respecting the law. If the local police claim jurisdiction over a case, it is less likely that they will hold the offender accountable to the environmental provision than the National Park Service.

Finally, financial constraints limit the ability for the National Park Service to enforce their laws. The National Park Service is the recipient of limited federal funds. The staff and equipment is limited and cannot cover the extensive grounds of the park on a regular basis. The lack of coverage means that offenses may go unnoticed.

The class has one day left in the Virgin Islands. Watch here for their final report.

Biodiversity Law 2010 - Over the Sea to Britain

Our third day took us to Jost van Dyke and Sandy Cay in the British Virgin Islands. Here is the University of Kansas School of Law Biodiversity Law class' account:

We went to Jost Van Dyke, a small island in the British Virgin Islands. After braving the sea and a small squall with our fearless Captain Ron, we arrived safely. We met with Susan who works for a non-profit organization that is committed to preserving biodiversity in the BVI. After our introduction Susan took us to a very small island called Sandy Cay. Sandy Cay was a private island owned by the Rockefeller family but was recently donated to the BVI government and is now designated a national park. It only takes twenty minutes to walk across Sandy Cay, however, it supports a very diverse ecosystem. The islands plant and land structure varies greatly from the sandy beaches on one side to the higher rock cliffs that support cactus. Before the island was donated it was used as a botanical garden and during this time people introduced several invasive species to the island including but not limited to rats, spider lilies and different species of palm trees.

When the BVI government acquired control and designated the land as a national park, some people involved with Susan’s organization worked diligently to eradicate the invasive species. They have successfully removed the rats. They still monitor the possible presence of rats, but there has been no evidence of rats inhabiting the island in six years. Because of the removal of the rats, the native species such as several different types of species of lizards, and soldier crabs have flourished on the island. The amount of lizards and solider crabs is vastly higher on Sandy Cay than on neighboring Jost Van Dyke. This is an example of how invasive species can decimate a population of native species and how removing the invasive species, the native populations can be restored and thrive.

The spider lilies are abundant on the island, however the removal of them has not been as widely supported because they are seen as threats, and they are quite beautiful when they bloom. However, judging by the shear mass of spider lilies on the island, it would be interesting to see what plants might flourish on the islands if this invasive species was removed.

In order to preserve the ecosystem of these islands, there needs to be a structured enforceable legal framework. Eradicating a species requires cooperation from the local governments. An example of this is the successful eradication of rats on Sandy Cay whereas Jost Van Dyke’s biodiversity is still plagued by the presence of mongoose and goats. Without local support it is impossible to begin and or carry out the lengthy process of eradicating these invasive species. Local people are opposed to the eradication of goats because they depend on them for their economic independence. The eradication of mongoose is opposed because the mongoose effectively controls snake populations, and while not poisonous the locals have a deep-rooted fear of snakes.

There are several ideas for future statutes and regulations to control invasive species. One idea would be to educate the local population on the benefits of biodiversity and the threats invasive species cause to the entire ecosystem including the people themselves. If the local people were more amenable to control invasive species, the invasive could easily be eradicated as evidenced on Sandy Cay. Another idea might be strict liability for releasing an invasive species. This strict liability should include not only fines for releasing the invasive but also liability for the costs of retribution including the costs of eradicating the species.

Despite the laws currently imposed or laws proposed, in order to see any benefits to biodiversity strong, consistent enforcement is necessary. There is extreme sporadic enforcement of environmental laws on the island causing most people to ignore them without the fear of repercussions that undermines the effectiveness of the law.

Tomorrow, the class will hike on Saint John, from mountaintop to seashore.

Biodiversity Law 2010 - Legislative Hearing

Today, the University of Kansas School of Law Biodiversity Law class was invited to Legislative hearings at the Virgin Islands Legislature. Here is the students' account of what they experienced and learned:

The US Virgin Islands have recently been consumed by a project that proposes to take combustible waste and petroleum coke (pet coke) and burn it to produce energy. This project is alternatively styled as a waste incinerator or waste-to-fuel project, among other terms. The project was put out to bid by the USVI WPA and a firm called Alpine won the bid to construct the project. In the lead-in to securing approval and permitting for the project, the territorial government and Alpine have engaged in public town hall meetings, and the USVI Senate scheduled hearings to gather facts about the project. These legislative hearings provided a forum for administrative officials, consultants, community leaders, and concerned citizens to voice their facts and opinions to the USVI senators concerning the proposed waste-to-fuel project to be built on St. Thomas. The hearings were conducted in the committee responsible for economic development and technology and included a witness list of just under twenty people. After being sworn in, each speaker was given five minutes to introduce themselves. Upon motion, the committee moved to allow each speaker ten minutes. In the afternoon, the Senators would pose questions to whichever witnesses they desired.

The proponents of the project spoke first. These included the executive director of the VI Water and Power Administration, the Commissioner of Planning and Natural Resources, and the Waste Management Authority executive. Accompanying these territorial government administrators were the consultants from the fields of law and engineering. The gist of the administrators and consultants’ presentation was that the incinerator project was an efficient way to remove garbage from the island while providing a relatively cheap and renewable source of energy. In addition, they repeatedly noted that the project met the best available control technology standards mandated by the EPA, although no standards for pet coke exist.

Opponents of the project included the president of the Bovoni homeowners association, the director of the St. John Community Foundation, environmental activists, and concerned private citizens. Their main concern was this project did not address the waste management problem in the Virgin Islands because current dumping sites would continue to leach toxic effluent, and the project would only account for a small percentage of the waste generated on the islands. Additionally, the opponents of the plant highlighted the potentially deleterious environmental and public health effects of the plant.

The hearings may or may not have had a lot to do with whether the plant is approved. The chairman of the committee indicated that the comments from the hearings would help the Senators make an informed decisions. Throughout our meetings with witnesses and senators and others, though, there was evidence that the decision may have already been made. In other words, the hearing’s real goal may be to let the public know that the Senators are seriously deliberating over the issue. If the Senate does approve the plant and the power purchasing agreement between WPA and Alpine, then further permits and laws may play a part in how the plant affects biodiversity.

Effects of the Proposed Incinerator on Biodiversity
The proposed incinerator could have a number of ramifications for biodiversity. The most direct effect will be felt through habitat destruction, as the proposed site is an undeveloped hillside. In order to build the site, the top of the hill will be leveled off. This could result in loss of species habitat, and some of the species affected include endangered animals, such as the Virgin Islands Tree Boa, and an endangered grass species. Construction will also result in erosion that will run into the ocean, possibly interfering with coral reef and other marine life, including endangered coral species. The long term effects from the operation of the plant mainly stem from pollution. The pollution could take the form of particulate matter, non-toxic releases, and toxic emissions. These emissions could fall down on the Virgin Islands and the surrounding seas, and possibly be swept through the air into more distant locations. More locally, the emissions can fall down onto the island and be absorbed into terrestrial and aquatic environments. The long-term buildup of toxics could affect endangered species on the island, and decrease habitat by disturbing vegetation. A secondary concern is what will happen to solid waste that results from the burning of ash and pet coke. This will have to be deposited somewhere, and may result in more habitat loss if an area must be cleared to place this waste.

Some existing laws could aid in combating the potential biodiversity loss from the incinerator. For instance, the Endangered Species Act could come into play because the incinerator could possibly result in a taking of endangered species. If the Fish and Wildlife Service were to get involved, the builders of the incinerator would have to be deal with the possible taking through mitigation activities. The Clean Air Act and Clean Water Act could also play a role in the regulation of the proposed incinerator. The Clean Air Act would have an effect by regulating the type of control technology that would have to be utilized in the emission of burned materials. Particulates will result from the burning of certain materials, and these are also regulated by the CAA. Additionally, because there is a national park nearby, the National Ambient Air Quality Standards (NAAQS) would probably apply; and so there would be a duty to keep the air of St. Thomas pristine. The Clean Water Act could play a 2 roles: first, the resulting solid waste would likely have to be dumped somewhere, and the incinerator would be subject to point source regulation. Second, the water could be affected by the burnt ash making its way into the watershed and could incidentally have an effect on the pollutant levels in the water regulated by the CWA.

Stay tuned for more tomorrow.

Biodiversity Law 2010 - Mermaid's Chair

For the 10th year in a row, Biodiversity Law is being taught in the Virgin Islands. Here is the University of Kansas School of Law Biodiversity Law class' report from Day 1:

Today we went to Mermaid’s chair, located in Botany Bay on St. Thomas in the United States Virgin Islands. First we walked along the beach and observed the native flora and fauna. We noted a variety of flora, ranging from cactus to sea grapes, and a variety of fauna, ranging from soldier crabs to pelicans. We then observed tide pools, which acted as natural hatcheries.

After exploring the land we hit the water for some snorkel time to observe the marine life. As we snorkeled for an hour and a half, we were impressed by the abundance of fish and coral in such a small area. As a group we estimated on average each person saw 35 “species” of fish and coral. A few examples are:

Fish:
Parrot fish
Blue tang
Squirrel fish
Zebra fish
Trumpet fish
Neon fish
Sea urchins
Snails
Ghost crab
Duster worm
Surf perch
Clown wrasse
Sergeant Major
Tube sponge
Flounder

Coral:
Brain coral
Staghorn coral
Fire coral
Pipe of pan coral
Elkhorn coral
Fan coral (in shades of yellow and coral)

Ecosystem Generally

Mermaid’s chair is a small cove at the intersection between the Caribbean and Atlantic. The cove is protected from the worst of the swells of the unprotected open sea, but enough waves crash into shore that the animals that call this place home must be adapted to the rough life. The water is temperate, with year round temperatures warm enough allowing for the existence of an incredible amount of coral and fish. Soldier crabs, ghost crabs, and snails live on virtually every land surface, from holes in the sand to various rock formations. The watershed feeding the cove with fresh water runoff is heavily forested and contributes little runoff or sediment, allowing for clearer water in the cove.

Policy Change/ Preexisting Laws For Mermaid’s Chair

Currently, there are laws and institutions in place for the conservation of biodiversity in Mermaid’s chair that could be applied to the existing ecological situation. For instance, the Endangered Species Act could prove useful to protecting many of the various organisms from coral to fish and birds. The Elkhorn coral is in such limited supply that is qualifies as an endangered species, as is the brown pelican. Extending the protection of the Endangered Species Act would ensure that government agencies had to be mindful of their actions as it would affect the endangered species. The ESA would also protect against takings by private parties; thus, individuals would be prevented from breaking coral or causing harm in any way to any endangered species. The ESA is already applicable to these endangered species, but further enforcement is necessary for the species to be effective.

Another possibility for conserving the biodiversity on the land and continuing to keep the beach a quiet and less-traveled beach is acquiring conservation easements on the private land currently slated for development. By stopping the development of the area, it would keep the integrity of the soil intact, would help prevent more destruction of native species, and keep further invasive species who hitchhike in on lumber and personal gardens out.

Possibilities for conserving the biodiversity at Mermaid’s chair include enacting zoning requirements and entering into use and development agreements with the builders. Zoning requirements would have to be enacted by the local government and would have to be constitutional in nature, but these could be anything as building density requirements to setbacks from the water. Entering into use and development agreements with the builders could accomplish these same goals, and could additionally require the development to be environmentally respectful and to preserve as much of the existing biodiversity as possible. These could take the forms of restricted covenants or contracts. This option allows the developers to take more initiative, and keep a better public relations perspective from the community and potential buyers.

There will be more tomorrow.

Video: Environmental Summit

Full video of the 11th Annual Northeast Florida Environmental Summit is now available online (this link will take you to the agenda, which links to each panel individually).

This interdisciplinary Summit, hosted by Florida Coastal School of Law and co-sponsored by Jacksonville University, featured eight panels and three plenary speakers addressing various issue areas under the broad theme of sustainability. Many of the presentations may be of interest to Biolaw readers, including the panles on Land Use, Biodiversity & Ecosystems, and Forestry & Agriculutre.

New Study Shows Serious Emotional Disturbances in Children Post Katrina

Mental health professionals have shown that there are serious emotional disturbances (SED) among children as a result of Hurricane Katrina. The Category 3 storm ravaged the Gulf Coast in August 2005. Characteristics of SED include inappropriate behavior, depression, hyperactivity, eating disorders, fears and phobias, and learning difficulties.

According to Virginia Tech News

A team made up of mental health professionals, emergency response experts, and researchers from several universities, including Virginia Tech, has published the results of a study that shows serious emotional disturbances among children who were affected by Hurricane Katrina. The Category 3 storm ravaged the Gulf Coast in August 2005.

The study, published in a recent issue of the Journal of the American Academy of Child and Adolescent Psychiatry, showed the estimated prevalence of serious emotional disturbances (SED) among residents of the affected areas was 14.9 percent. Of those, 9.3 percent of youths were believed to have SED that was directly attributable to Hurricane Katrina.

"Stress exposure was associated strongly with serious emotional disturbances," said Russell Jones, professor of psychology in the College of Science at Virginia Tech and member of the research team. "More than 20 percent of the youths with high stress exposure had hurricane-related SED."

The study found that youth who experienced death of loved one during the storm had the strongest association with SED. Exposure to physical adversity was the next strongest.
"The prevalence of SED among youths exposed to Hurricane Katrina remains high 18 to 27 months after the storm," Jones said. "This suggests a substantial need for mental health treatment resources in the hurricane-affected areas."

Katrina was the costliest hurricane in United States history as well as one of the five deadliest. Four years after the storm, nearly thousands of residents of Mississippi and Louisiana are still displaced from their homes.

Join me for a book discussion

A few months ago, Oxford published When Cooperation Fails: The International Law and Politics of Genetically Modified Foods, an interesting new book by Gregory Shaffer and Mark Pollack. Today, Opinio Juris is hosting a one-day book discussion about the book, with yours truly as a guest blogger. Please join the conversation--it should be fun!

Heat In Our Time

They came, they jawed, they Accorded. The 15th United Nations Climate Change Conference ("COP15") is now history. When I was in Copenhagen recently, both the pride of the Danish in hosting COP15 and their high hopes for a diplomatic breakthrough to tackle climate change were tangible. For example, the spirit was festive in the Kongens Nytorv, a major public square in the city's center, despite its being filled with dozens of large globes representing different interpretations of climate change's perils and a large exhibition of human-sized photos depicting habitats and inhabitants from around the world endangered by rising concentrations of greenhouse gases. Danes I spoke to seemed to believe a meaningful treaty to reduce greenhouse gas emissions was likely.

It is early days yet, but there are some worrying signs that Hopenhaven may instead have become Nopenhaven. Discord between less and more developed countries was immediately a dominant theme, and at one point a number of delegates from African countries actually brought official proceedings to a halt to protest perceived intransigence and injustice by "rich" developed countries. Connie Hedegaard resigned her post as COP15's president partway through the conference. Most significantly, the conference ended without a draft - let alone signed - treaty. Instead, the world was left with a consolation prize of uncertain vitality: the "Copenhagen Accord" that COP15 made a rather hollow "decision to note".

The New York Times lamented that

Despite two years of advance work, the meeting failed to convert a rare gathering of world leaders into an ambitious, legally binding action plan for reducing greenhouse gas emissions.

The Financial Times' editorial page pronounced a more lacerating judgment: "Dismal outcome at Copenhagen fiasco". Finally, environmental groups from around the world came to their own coincidental "Copenhagen Accord" with the market for trading carbon emissions, where the European Union’s December 2010 carbon contract declined 8% today to €12.41 per tonne after declining by a similar amount last week. Talk may be cheap, but so, in wake of COP15, is emitting carbon.

REDD Financing

AP reports that talks over REDD are faltering because developed countries are not willing to finance developing country readiness for the program. This is not surprising since financing disputes have repeatedly limited the development of international environmental law. The significance of financing disputes are nowhere more apparent than in the history of efforts to secure a binding international agreement to slow deforestation (which, after over 16 years of on-and-off efforts, is not even close to realization).

However, REDD promises a way to overcome the issues that have derailed prior efforts to secure tropical forest protection. Among other things, it offers developed countries an opportunity to buy carbon credits for less than the cost of reducing their domestic emissions, while giving developed countries a chance to sell credits for more than the costs of avoiding deforestation . . . if they can establish the necessary verification and monitoring systems to demonstrate avoided deforestation.

I've offered an option for incentivizing protection of biodiversity through a voluntary certification option within REDD in a recent article. I think that a similar approach could offer a way around the current financing disputes as well. REDD could be a two-tier system that offers a choice for developing countries to develop either relatively streamlined mitigation projects without international financing, or more elaborate adaptation-oriented REDD projects with certification for biodiversity and socio-economic co-benefits that is underwritten by international assistance. I am currently working on an article to develop this concept, but it certainly won't be ready by the time negotiations wrap up later this week. :-)

Cross-posted here.

U.S. Food Safety System In Serious Disrepair

More than 50% of food manufacturers are unaware of their legal obligation to provide the FDA with updated contact information that the FDA relies on to deal with emergencies, such as Salmonella or other forms of food contamination. According to a Report released yesterday by The Department of Health and Human Services, Office of Inspector General, federal auditors found that approximately 48% of surveyed manufacturers failed to provide the FDA with accurate contact information and approximately 25% provided no emergency contact information at all.

The GAO Report explains:

Each year, more than 300,000 Americans are hospitalized and 5,000 die after consuming contaminated foods and beverages. In the event of an outbreak of a foodborne illness, FDA is responsible for finding the source of the contamination and helping to remove the contaminated food products from the food supply chain. Recent outbreaks of foodborne illness involving peanut butter, peppers, and spinach have raised serious questions about FDA’s ability to protect the Nation’s food supply.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires certain food facilities to register with FDA. The purpose of registration is to provide FDA with sufficient and reliable information about food facilities. This information enables FDA to quickly locate facilities during an outbreak of foodborne illness and to locate these facilities for inspection.

FDA requires each domestic food facility to provide information for the registry, including (1) contact information (i.e., name, full address, telephone number, and all trade names under which the facility conducts business); (2) contact information for the parent company; (3) contact information for the owner or operator of the facility; and (4) an emergency contact telephone number. If there is a change in a facility’s information, such as a new name or address, the facility must provide FDA with the updated information within 60 days. The information provided by facilities is stored in a database called the FDA Unified Registration and Listing System .....

Hat tip: Bill Marler at Marler Blog.

Biodiversity Loss Can Increase Infectious Diseases in Humans

Queensland's Daintree Rainforest, said to be 135 million yeras old, containing more rare and endangered plant and animal species than any other area

Fifty years ago, improved public health measures, the development of antibiotics, better vaccines, insecticides and advancements in surveillance resulted in a decline of infectious disease. However, an upturn in infectious diseases around the world, both emergence and reemergence, has been apparent since the late twentieth century. This increase marks the fourth major alteration in human-microbe relationships since the introduction of agriculture over 10,000 years ago.

This “epidemiologic transition” has triggered the development of new infectious diseases. Approximately 30 new diseases have been identified and old diseases have reemerged with a vengeance, like tuberculosis, malaria and cholera. These new diseases include human immunodeficiency virus/acquired immune deficiency syndrome (AIDS), Legionnaires’ disease, bovine spongiform encephalopathy (BSE)/variant Creutzfeldt-Jakob disease (vCJD), hepatitis C, Nipah virus, new hemorrhagic fevers as well as severe acute respiratory syndrome (SARS) and avian influenza.

Various changes in human ecology have contributed to this new era of infectious disease:

∙ rural-to-urban migration resulting in high density peri-urban slums;
∙ increasing long-distance mobility and trade;
∙ the social disruption of war and conflict;
∙ changes in personal behavior; and,
∙ the use and misuse of medical technology (e.g. the creation of drug resistant microbes).

Weiss, R., McMichael, A.J., Social and Environmental Risk Factors In The Emergence of Infectious Disease, 10 Nature Med. Supp. 570 (December, 2004).

Recently, more attention has been paid to the role of human-induced global changes in the increase in infectious disease, including widespread forest clearance and climate change. In a newly released study, “Biodiversity Loss Affects Global Disease Ecology,” which will be appearing in the December 2009 issue of BioScience, the authors review and combine a broad group of studies addressing this issue and conclude that there is an association between the current epidemiologic transition and biodiversity change, decline and extinction. As reported in ScienceDaily

‘Habitat destruction and biodiversity loss,’ -- driven by the replacement of local species by exotic ones, deforestation, global transportation, encroaching cities, and other environmental changes – ‘can increase the incidence and distribution of infectious diseases in humans,’ write University of Vermont biologist Joe Roman, EPA scientist Montira Pongsiri, and seven co-authors in BioScience.

According to ScienceDaily, Roman explains that "people have been working on this in individual diseases but no one has put all the studies together to compare them."

In 2006, he and Pongsiri gathered a group of scientists and policy analysts with expertise in a range of the new diseases being observed -- including West Nile virus as well as malaria, the African parasitic disease schistosomiasis, hantavirus pulmonary syndrome, and several others. From that meeting, the forthcoming BioScience study developed.

'We've reviewed all those studies and show that emergence or reemergence of many diseases is related to loss of biodiversity,’ says Pongsiri. 'We've taken a broad look at this problem to say that it's not just case-study specific. Something is happening at a global scale.’

‘We're not saying that biodiversity loss is the primary driver for all of these emerging diseases,’ says Roman, ‘but it appears to be playing an important role.

'We're trying to make the case that all of these environmental changes we're making, because they are anthropogenic, can be managed, can be controlled,’ says Pongsiri. ‘We may be able to actually reduce or prevent these diseases by managing for biodiversity from the genetic level to the habitat level.’

This new study is part of growing body of work in an area being referred to as Eco-epidemiology. This relatively new field of study brings epidemiology and ecology together to examine the relationship between biodiversity and public health. Among other issues, Eco-epidemiologists examine disease prevention in terms of habitat structure, promoting genetic diversity in non-human species and the protection of animal predators as ecosystem regulators.

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.