USDA Decides GM-Alfalfa Is No Little Rascal

Alfalfa (Medicago sativa) is one of the most important crop plants in the world. Its uses range from cattle forage to human food. Worldwide, it is cultivated more than any other legume crop. Monsanto Corporation developed a patented genetically modified ("GM") variety of alfalfa - Roundup Ready Alfalfa - that is resistant to glyphosate (N-(phosphonomethyl) glycine), a powerful herbicide used to eliminate weeds from agricultural fields.

As discussed earlier at LEXVIVO, Roundup Ready Alfalfa has inspired considerable legal controversy - controversy that has already reached the U.S. Supreme Court. On January 27, 2011, the United States Department of Agriculture ("USDA"), after completing an Environmental Impact Statement, announced in a press release that it has opted for full deregulation of Roundup Ready Alfalfa.  This decision will place no more restrictions on Monsanto's GM-alfalfa than on non-GM varieties.  As the USDA's press release relates,

"After conducting a thorough and transparent examination of alfalfa through a multi-alternative environmental impact statement (EIS) and several public comment opportunities, APHIS has determined that Roundup Ready alfalfa is as safe as traditionally bred alfalfa," Agriculture Secretary Tom Vilsack said.

This decision comes on the heels of a January 19, 2011, letter that U.S. Representative Frank Lucas (R-Okla.) and U.S. Senators Saxby Chambliss (R-Ga.) and Pat Roberts (R-Kansas) sent to USDA Secretary Tom Vilsack, warning that taking into account non-scientific factors in the regulation of GM-alfalfa would exceed the statutory authority granted to his agency by the Plant Protection Act:

It is unfortunate that those critical of the technology have decided to litigate and as you rightly point out that courts may unwisely interfere in normal commerce. However, the alternative you propose and include in the EIS is equally disturbing since it politicizes the regulatory process and goes beyond your statutory authority and indeed Congress’ intent in the Plant Protection Act (PPA). The PPA requires the Secretary to make a scientific determination if the product under review is a plant pest (7 U.S.C. 7711(c)(3)). If the final decision is that the product is not a plant pest, nor would the movement of the product in question impose the risk of dissemination of a plant pest, then USDA has no authority to impose further restrictions (7 U.S.C. 7712(a)).

Further legal challenges of GM-alfalfa are certain, especially from organic farmers who worry that GM-pollen will infect the their non-GM crops.  As a signal that it takes the growing war between advocates of agricultural biotechnology and organic farming seriously, USDA has decided to resurrect its Advisory Committee on Biotechnology and 21st Century Agriculture and the National Genetic Resources Advisory Committee to

tackle a broad range of issues, from ensuring the availability of high quality seed, to helping ensure that growers have access to the best tools available to support their production choices, to whether risk management and indemnification options can play a role.

Victory in this battle goes to agricultural biotechnology, but the wider war will assuredly continue.  In the meantime, the Food and Agriculture Organization of the United Nations ("FAO") has reported that food prices reached near-record heights in 2010.

Innovation As An Innovation

On January 25, 2011, U.S. President Barack Obama delivered a State of the Union Address packed with references to innovation.  In fact, he mentioned "innovation" no fewer than nine times during his speech.  In each of his 2010 and 2009 Addresses, President Obama mentioned innovation only twice.  During his entire eight years as U.S. President, George W. Bush mentioned innovation quite sparingly in State of the Union Addresses:  twice each in 2006 and 2003.  Even technophile President William J. Clinton employed the word only four times in his two terms in office.  So, why is innovation suddenly so popular with President Obama?

There are a number of possible explanations for why innovation has caught the presidential, and national, Zeitgeist.  One reason is that technological innovation is closely associated with economic growth.  From Robert Solow's neoclassical growth model, which estimated that about four fifths of productivity gains stem from new technology, to Paul Romer's suggestion that investments in research and development may be particularly effective means of encouraging technological improvements, much modern economic thought recommends the promotion of innovation as an especially wise policy goal.

Another motivation is the fashionable fear that the United States is at risk from being overtaken by China, whose students (along with students from South Korea, Finland, Canada, and quite a few other countries) recently outperformed their American colleagues in science, mathematics, and other subjects in the Organisation for Economic Cooperation and Development's Programme for International Student Assessment ("PISA").  The sensation caused several weeks ago by Amy Chua's publication of Battle Hymn of the Tiger Mother, in which she critiques the results of what she pejoratively terms "Western" parenting, tapped this Angst and found a gusher.

A third explanation may arise from a dawning realization that classical models of innovation may not be succeeding as well as they once did.  Witness the National Institutes of Health's new National Center for Advancing Translational Sciences ("NCATS"), whose euphemistic goal, "to leverage science to bring new ideas and materials to the attention of industry by demonstrating their value," is a reaction to the worrying relative decline in the rate of discovery, development, and market-availability of new pharmaceutical drugs, coupled with a looming "patent cliff" off which many existing medicines are beginning to tumble.

Finally, the fruits of innovation, such as the iPad, the Nissan Leaf, and Roundup Ready alfalfa, are usually viewed as cool, compelling, and a welcome distraction from the distressing realities of slow economic growth and high unemployment.  Where the Romans had panem et circenses, one can now enjoy the latest update of Angry Birds.

Biodiversity Law In Paradise - Day Six

Every year, the students in Biodiversity Law travel with Professor Andrew W. Torrance to the Virgin Islands (U.S. and British) for an intensive week-long fieldtrip.  This is their dispatch from January 19, 2011:

Today, we got up early to drop our fearless leader and professor off at the airport.  We immediately left the airport to make our way to the beach beside the University of the Virgin Islands ("UVI") MacLean Marine Science Center docks.  We are grateful that the local United States Virgin Islands laws require that the public be given access to all beaches on the islands.  After visiting UVI multiple times this past week as a transit point, it was great to be able to go to the beautiful beach there and do some snorkeling close to the shore.

Formal lectures and field activities having finished, we lounged around the beach as we waited for the sun to rise over the palm trees to illuminate the water for clear-visibility snorkeling. While on the beach, we watched a Brown Booby (Sula leucogaster) dive repeatedly from the air into the water to catch fish.  Also, we saw a Puerto Rican Anole (Anolis pulchellus), a lizard that falls into the grass/bush morphotype.  Two other anole lizards, the Puerto Rican Crested Anole (Anolis cristatellus), a trunk/ground morphotype, and the Barred Anole (Anolis stratulus), a crown/trunk morphotype, are native to the Virgin Islands, and we saw these as well.  Part of our reading assignments were about the anole lizards of the Virgin Islands, and we used these organisms in legal hypos throughout the week of the fieldtrip.  We tried to catch these lizards all week to examine them up close, but without success.  Finally, the Anolis pulchellus that we found near the beach’s tree line took pity on us, and decided to jump on an arm. 

Once the sun was shining over the bay, we went snorkeling. We saw schools of Ballyhoo (Hemiramphus brasiliensis) fish almost immediately.  The bay, which is called Brewer's Bay, itself was largely sandy-bottomed, and had almost no coral.  However, plenty of small fish were nibbling at the few pieces of coral that are present.  One fish appeared to be territorial, aggressively protecting its part of the coral from all other fish who swam too close.  As we swan out towards the moored boats, we saw some Green Sea Turtles (Chelonia mydas), a turtle federally-listed as endangered under the federal Endangered Species Act, enjoying morning swims.  One particular turtle alarmed us by lunging towards us.  It became very clear that Green Sea Turtles are much more agile in the water then we were.  Luckily, the turtle decided we represented no threat, and subsequently left us alone.  Surprising, we also saw a Southern Stingray (Dasyatis americana), our first of the fieldtrip.  We found it amazing how each snorkeling trip this week revealed new species.  It is precisely this richness and variety of biodiversity, along with the many legal issues that confront and surround it, that makes the Virgin Islands such an ideal place to study biodiversity law.

Unfortunately, all good things must come to an end.  Our trip has officially ended, but we will carry with us all the knowledge we gathered in our unique ‘classroom’ this week.

That brings to an end the daily dispatches from the 2011 Biodiversity Law class.  See you again this time next year for the 2012 class of Biodiversity Law.

Biodiversity Law In Paradise - Day Five

Every year, the students in Biodiversity Law travel with Professor Andrew W. Torrance to the Virgin Islands (U.S. and British) for an intensive week-long fieldtrip.  This is their dispatch from January 18, 2011:

 

Today, Ron, an experienced sea captain, and the owner of our hotel, took us on his speedboat to the U.S. Virgin Island of Saint John.  St. John is unique in the Caribbean in consisting mainly of national park.  Made possible by land donated by Laurance Rockefeller, Virgin Islands National Park covers most of St. John, and has allowed the island to maintain more of its natural character and native biodiversity than any other Caribbean island.  Unlike the largely unsuccessful laissez-faire approach to conservation that characterizes St. Thomas and St. Croix, the National Park Service provides strong federal enforcement of national biodiversity law on St. John.  For example, where St. Thomas hosts hillsides dotted with structures and cleared vegetation, the only structures visible on the North side of St. John, aside from a few privately-owned enclaves yet to be acquired by the National Park, are abandoned colonial sugar mills and the ecotourism tents of Maho Bay.  The habitats on St. John vary from mature seasonally-moist rainforest to dry sclerophyll forest, surrounded by an unspoiled shoreline of rocky cliffs and gorgeous white sand beaches, with spectacular coral reefs just offshore.

We moored the boat at Leinster Bay, and snorkeled around Waterlemon Cay.  The snorkeling here differed markedly from our previous snorkling sites South of St. Thomas.  Here, the fish tended to be much bigger and more plentiful, and we were able more easily to identify more species.  In addition, we saw many large fish hiding in crevices in the coral.  Much of the coral surrounding Waterlemon Cay was soft and flexible, allowing it to bend and ‘wave’ in the strong water currents and larger waves.  We observed more endangered Staghorn Coral (Acropora cervicornis) and Elkhorn Coral (Acropora palmata), though not in the same abundance as at Flat Key.  One more fascinating characteristic of Waterlemon Cay was the abundance of tiny translucent Sea Walnuts (Mnemiopsis leidy), which, fortunately, tend not to sting.

After snorkeling, we returned to our al fresco classroom, where we discussed our favorite creatures (especially legal issues involved in their conservation), and then calculated the species richness, evenness, and diversity of the three St. Thomas locations (Botany Bay, Crown Mountain, and Magen's Bay) at which we carried out leaf surveys. The largest species richness and biodiversity was at Crown Mountain (the highest point in St. Thomas), followed by Magen's Bay (halfway down the mountain), and then Botany Bay  (near the beach). Crown Mountain is a moist rainforest area, whereas Magen's Bay and Botany Bay (in that order) are generally drier. Additionally, results revealed that Botany Bay had less species richness and biodiversity. Again, this was not very surprising because the area is near water and very sandy.  In terms of species richness, diversity, and evenness, the Magen's Bay area is intermediate to the other two sites in richness, evenness, and diversity.  Our calculations confirmed our expectation that the Virgin Islands host prodigious quantities of biodiversity, but that the local patterns of biodiversity vary immensely.

Stay tuned for more daily dispatches.

Biodiversity Law In Paradise - Day Four

Every year, the students in Biodiversity Law travel with Professor Andrew W. Torrance to the Virgin Islands (U.S. and British) for an intensive week-long fieldtrip.  This is their dispatch from January 17, 2011:

Today, we drove down to Estate Botany Bay in the far westend of Saint Thomas.  There, we visited the lowlands area surrounding the former Corning family beach house, Mermaid’s Chair, and The Nature Conservancy ("TNC") property called Little Saint Thomas, which is situated where the Caribbean Sea meets the Atlantic Ocean (and creates the best surfing in the Virgin Islands).  We learned how TNC pioneered the use of conservation easements to conserve parcels of land without having to pay the total cost of purchasing land fee simple. A conservation easement prevents activities on a parcel of land that might endanger biodiversity. Unlike their usual legal strategy of obtaining conservation easements from property owners, TNC actually does own Little Saint Thomas fee simple, having been given the land by the Corning family as a gift. Per USVI law, public access to the beach and ocean is required so that the public can use and enjoy the land.  However, those wishing to enjoy these access rights must walk (not drive) the 3 kilometers down to the beach, and then walk back up.  Fortunately, we were guests of private owners of Botany Bay, so we were allowed to explore the entire 160 hectare property and its spectacular tropical biodiversity.

One of the most interesting features of Little Saint Thomas was the abundance of rocks that allow for the formation of transient tide pools. These tide pools serve as an area where small, often juvenile, fish can live protected from larger predator fish.  Also, we saw an abundance of Soldier Crabs (Coenobita clypeatus) making their way inland, and uphill, to mate and lay eggs, a behavior they share, at least in part, with sea turtles.  Unfortunately, roads cut into the sides of the steep hills of Estate Botany Bay can create vertical barriers impossible to pass, thus thwarting their uphill reproductive trek.

After leaving Estate Botany Bay, we drove up to Crown Mountain, which is the highest point in the USVI, and home to a dense biodiverse moist rainforest, and then down to the trailhead of another TNC property above Magen’s Bay. At both of these sites, and at Botany Bay, we systematically collected fallen leaves as part of an experiment to estimate forest diversity. We then took bags of our leaves back to our hotel, where we carefully categorized and tallied the different types of leaves we collected at each of the three experimental sites.  Tomorrow, we will use a variety of statistical formulae to estimate forest tree richness, diversity, and evenness across these sites, and will then attempt to understand any differences we find.

Stay tuned for more daily dispatches.

Biodiversity Law In Paradise - Day Three

Every year, the students in Biodiversity Law travel with Professor Andrew W. Torrance to the Virgin Islands (U.S. and British) for an intensive week-long fieldtrip.  This is their dispatch from January 16, 2011:

Today, Dr. Richard Nemeth, a specialist in ecology and management of tropical fisheries and coral reefs, and the Director of the Maclean Marine Science Center at the University of the Virgin Islands, took us out on his sailboat. He took us for a sail around a few of the small islands surrounding the southern side of St. Thomas.  After serving as his crew to sail out to Flat Cay, a small, uninhibited island, and federally-protected bird sanctuary, we moored to a fixed buoy, thus avoiding the need to drop anchor onto the spectacular, yet fragile, coral reef below.  We saw a bewildering diversity of fish, echinoderms, crustaceans, coral, and sponges.  Dr. Nemeth graciously and expertly pointed out a number of interesting species.  For instance, he pointed out a school of Blue-Headed Wrasse, and explained that their unusual closely-synchronized swimming pattern was part of a mating ritual, in which as many as twenty male fish attempted to follow a single female fish to fertilize the eggs she occasionally released into the water.  Although comical to watch, this mating aggregation behavior is crucial to producing the next generation of this species on the coral reef.  Dr. Nemeth also drew our attention to endangered Fused Staghorn Coral (Acropora prolifera), a rare species of coral that results from the hybridization of endangered Elkhorn Coral (Acropora palmata) and Staghorn Coral (Acropora cervicornis).  In addition, he showed us a coral nursery set up by The Nature Conservancy intended to produce individuals of these three coral species that can be used to establish new populations where they have previously been wiped out. We were also very excited to see, and swim with, two Green Sea Turtles (Chelonia mydas), an inspiring sight because these turtles are currently making a comeback in the waters surrounding the Virgin Islands.

After sailing back to the docks at the Maclean Marine Science Center, Dr. Nemeth showed us a captured Red Lionfish (Pterois voltans).  Red Lionfish are an increasingly problematic invasive species in the Virgin Islands, and throughout the Caribbean, and anyone spotting one of these fish in the wild is strongly encouraged to report their sighting to the fish and wildlife authorities. Native to the Indian and Pacific Oceans, the Red Lionfish has rapidly spread throughout the Caribbean Sea after Hurricane Andrew smashed a Miami aquarium, spilling six individual Red Lionfish into the Atlantic Ocean who subsequently spawned the entire invasive plague.  Since the Red Lionfish has no natural predators outside its natural range, and each individual is capable of consuming vast numbers of coral reef fish, its spread is currently devastating native fish biodiversity in the Caribbean region.  Though beautiful, this fish symbolizes the current lack of effective legal responses to the threat of invasive species.

Stay tuned for more daily dispatches.

Biodiversity Law In Paradise - Day Two

Every year, the students in Biodiversity Law travel with Professor Andrew W. Torrance to the Virgin Islands (U.S. and British) for an intensive week-long fieldtrip.  This is their dispatch from January 15, 2011:

Today we had the amazing opportunity to visit with the USVI’s most distinguished attorney, Jeff Weiss.  Jeff Weiss is a jack of all trades.  He handles issues varying from complex class action litigations, such as the recovery of insurance money from a hurricane that devastated the island of St. Thomas over a decade ago, and also advocates zealously for the protection of endangered species, such as the endangered Atlantic Hawksbill Sea Turtle (Eretmochelys imbricata) and Virgin Island Tree Boa (Epicrates monensis granti).  Jeff explained the intricacies of practicing law in a U.S. territory that is a biodiversity hotspot.  The most interesting aspect of our conversation was the balancing of interests between the Virgin Island Tree Boa and the Hawksbill Sea Turtle and the people who lost their homes because of Hurricane Marilyn.   Jeff ardently fought for the protection of endangered species whose habitat would have been destroyed through habitat destruction by relying on the Endangered Species Act. And he won!

Stay tuned for more daily dispatches.

Biodiversity Law In Paradise - Day One

Every year, the students in Biodiversity Law travel with Professor Andrew W. Torrance to the Virgin Islands (U.S. and British) for an intensive week-long fieldtrip.  This is their dispatch from January 14, 2011:

Professor Torrance informed us that we would partake in a traditional Saint Thomas Friday night activity;  we went bat catching.  We trekked along the beautiful shoreline of Magen's Bay before having the honor of meeting Saint Thomas' foremost advocate for terrestrial ecosystem preservation, Dr. Renata Platenberg.  She and two assistants, her devoted husband and a University of the Virgin Islands graduate student, mount mistnets in the forest once a month at dusk.  Various specimens of the island's five native species of bats occasionally find themselves tangled in the nets, perhaps a bit confused that their sonar failed them.  Promptly, the researchers delicately remove the tiny mammals (unfortunately, the process is delicate only for the bats-- a bat bite and some mild cursing was in progress when we arrived) and place them in pillow cases for weighing, measuring, and then safe release.  While the idea of petting a bat was both exciting and off-putting, the consensus among the class was that explaining a bat bite scar would be rather impressive, thus worth the risk.  We introduced ourselves to the little lady in the photo, who was soft as velvet and surprisingly cute.  Renata and her crew then examined the bats, recorded data, and returned them to their homes among the palm tree silhouettes.  The promise of Friday night island excitement panned out beautifully as we found a friend in Molossus molossus.  And we got a taste of the first step in determining whether a species might be threatened:  someone has to venture into the trenches, observe species first hand, and establish the scientific baseline that triggers the protective provisions of the Endangered Species Act.

Stay tuned for more daily dispatches.

An Apple Patent A Day Keeps Competitors At Bay

The big news about Apple Inc. is not their new agreement to sell iPhones that work on Verizon Wireless' 3G network.  Much more significant is newly released evidence that Apple aspires to become a patent superpower.  On January 12, 2010, patent information company IFI CLAIMS Patent Services published a new league table ranking the assignees of the most U.S. patents granted in 2010.  For the first time, Apple, at 46th, made it into the top 50, and was the assignee of 563 newly granted patents.  Although it leads the top 50 in growth rate, with a 94% increase in assigned patents since 2009, Apple still has a long climb to match the top patent assignee, International Business Machines Corporation, which received an astonishing 5,896 patents in 2010.  Nevertheless, Apple has already begun to flex its patent-strengthened muscles, particularly in the increasingly important market for smartphones.  Apple appears to be investing in an expansive patent estate to protect its prodigious profits, perhaps signaling its transition from iPhone to iSue.

The Foody Blues - FDA Of Future Passed

On January 4, 2011, President Obama signed into law the Food Safety Modernization Act ("FSMA"), which the U.S. Senate and House both passed in late 2010. The FSMA amends the existing Food, Drug and Cosmetics Act in numerous ways, but four changes stand out in particular:

(1) FDA must develop and employ science-based standards that govern the growing and harvesting of fruits and vegetables, and these standards must take into account both anthropogenic and "natural" risks to food safety,

(2) Food facilities must produce written assessments that identify risks to the food they handle, and specify prophylactic measures to minimum these identified risks,

(3) FDA must greatly step up its inspections of food facilities, both in the U.S. and abroad, and

(4) FDA will now possess enhanced recall authority, allowing the agency to force recalls of unsafe food if the producer of the food fails to do so voluntarily, and will be able to suspend registration of food facilities connected to unsafe food.

Here is how Food and Drugs Commissioner Margaret Hamburg describes the new FSMA: 

Each year, foodborne illness strikes 48 million Americans, hospitalizing a hundred thousand and killing thousands.  I thank the President and members of Congress for recognizing that the burden that foodborne illness places on the American people is too great, and for taking this action.

The historic legislation the President will sign tomorrow directs the Food and Drug Administration, working with a wide range of public and private partners, to build a new system of food safety oversight – one focused on applying, more comprehensively than ever, the best available science and good common sense to prevent the problems that can make people sick...

This law represents a sea change for food safety in America, bringing a new focus on prevention, and I expect that in the coming years it will have a dramatic and positive effect on the safety of the food supply.

Two of the greatest challenges faced by the FDA in implementing the FSMA will be time and money.  To meet the aggressive schedule of inspections and other actions mandated by the FSMA, the agency will have to hire many new employees with expensive scientific credentials.  The new Republican-dominated House may balk at supplying any new funds in the new era of austerity they have announced.  However, food safety is a very popular political issue, and woe betide the future electoral prospects of any politician seen to be advocating less of it.

Patently Innovative China

China long ago became a manufacturing superpower.  However, its earlier-industrialized competitors have consoled themselves that China is merely a copycat of others' innovation.  The government of China is not content with such a role.  Even though the evidence that patents best spur innovation is far from conclusive, the Sunday New York Times today (January 2, 2011) reports that patents are a central pillar in the official Chinese strategy to foster a culture of home-grown invention.

The article, "When Innovation, Too, Is Made in China," references a document entitled "National Patent Development Strategy (2011-2020)," recently published by the State Intellectual Property Office of China ("SIPO"), and suggests that China plans to double its complement of patent examiners and to increase its utility patent filings to an impressive 1,000,000 by 2015.  By contrast, the United States Patent and Trademark Office ("USPTO") employed 6,413 utility, plant, and reissue patent examiners in the fourth quarter of 2009, and, during the whole of 2009, received 456,106 utility patent applications, of which 49.3% had a U.S. resident as first-listed inventor.  As the article also notes, to increase patent filings by its own residents, "China has introduced an array of incentives [including] cash bonuses, better housing for individual filers and tax breaks for companies that are prolific patent producers."

China may find, as other countries have before, that the connections between patents and innovation remain less than fully elucidated.  As Eric von Hippel has persuasively demonstrated, much innovation is either open (that is, non-proprietary), generated by users rather than producers, or both.  James Besson and Michael Meurer have shown that the relative costs and benefits of patents differ between fields, and the costs may sometimes outweigh the benefits.  And, the results of experiments (for example, see the article "Patents and the Regress of Useful Arts," published in the Columbia Science and Technology Law Review (2009)) by Profs. Bill Tomlinson and Andrew W. Torrance (author of LEXVIVO) using a variety of simplified computer-based simulations of patent systems have found relatively greater rates of innovation in systems lacking patent protection (for more, see the August 16, 2010, Google Tech Talk "The Patent Game:  Experiments in the Cathedral of Law").

Patent law, patent economics, and the innovation process are all exceedingly complicated.  Even an otherwise fascinating New York Times article stumbles on specifics, stating that, unlike China, "[i]n the American system, there are no utility patents," despite the fact the United States patent system does, indeed, offer utility patents;  where China does differ is in offering petty patents ("utility model" protection) for minor incremental innovations.  Better public understanding of the specifics of patent systems would help improve policy debates about innovation.  More fundamentally, much additional research will be required to determine the conditions under which patent systems best spur innovation.  By setting an aggressive set of patenting goals, China is clearly signaling its intentions to become a patent superpower.  However, achieving the status of innovation superpower may require more than patents alone.