Bayer to pay $750 Million to End Lawsuits Over Genetically Engineered Rice

According to Bloomberg, Bayer AG agreed to a $750 million settlement to resolve claims with about 11,000 U.S. farmers who said a strain of the company's genetically modified rice tainted crops and ruined their export value. The settlement ends scores of lawsuits filed against the Bayer CropScience unit by farmers in Texas, Louisiana, Missouri, Arkansas, and Mississippi.

In August 2006 the USDA said that trace amounts of the company's experimental LibertyLink strain were found in U.S. long-grain rice. Within four days, declining rice futures cost U.S. growers about $150 million, according to a complaint filed by the farmers.

The official Bayer CropScience statemen states in part, "Although Bayer CropScience believes it acted responsibly in the handling of its biotech rice, the company considers it important to resolve the litigation so that it can move forward focused on its fundamental mission of providing innovative solutions to modern agriculture."

Summary of Key Provisions of the Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), which signed into law by President Obama on January 4, 2011, amends the Federal Food, Drug, and Cosmetic Act to shift the focus of the Food and Drug Administration (FDA) from primarily reacting to food safety problems to prevention.

A summary of key new provisions and their impact is available on the Institute for Food Laws & Regulations website here.

Neal Fortin is the author of Food Regulation: Law, Science, Policy, and Practice, and he is Professor and Director of the Michigan State University Institute for Food Laws and Regulations, where he teaches online courses in Food Regulation in the United States, International Food Law, and Codex Alimentarius. 

FDA's Nanotechnology Guidance

Nanotechnology is the science of manipulating materials on the nanoscale.  “Nanotechnology,” “nanoscale,” and related terms lack definitions in U.S. food law. However, common use of the term “nanotechnology refers to the engineering (deliberate manipulation, manufacture, or selection) of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers.

Nanotechnology is an emerging technology that has the potential to be used many products, including drugs (e.g., to increase bioavailability) and foods (e.g., to improve food packaging). Nanoscale materials can have different chemical, physical, or biological properties compared to their conventionally scaled counterparts. These materials warrant further regulatory attention because the properties and phenomena of nanoscale materials can affect safety, effectiveness, performance, and quality of the materials. 

Rather than define nanotechnology, FDA issued draft guidance on nanotechnology that defines when the agency increase product scrutiny based on the application of nanotechnology. Specifically, FDA will ask:

1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or

2.  Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer.

  

Note that FDA is interested in the engineered nanoscale materials and the application of nanotechnology as distinguished “from those products that contain incidental or background levels of nanomaterials or those that contain materials that naturally occur in the nanoscale range. FDA is particularly interested in the deliberate manipulation and control of particle size to produce specific properties, because the emergence of these new properties or phenomena may warrant further evaluation. This is distinct from the more familiar use of biological or chemical substances that may naturally exist at small scales, including at the nanoscale, such as microorganisms or proteins.”

  

FDA’s product focused review is similar to the agency’s regulatory policy for recombinant DNA techniques (GMOs). As with GMOs, FDA does not categorize the technology as either benign or dangerous. A product’s final attributes determine the outcome of FDA’s review. However, the agency considers the process of a product’s development as a part of the means for determining the attributes of the final product.

FDA’s draft guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Draft Guidance for Industry (June 2011) is available here. 

A more sophisticated crisis response

Alberto Alemanno has a thought provoking article regarding the response to the recent E. coli outbreak. Would it have been better if the European Commission had taken on more powers?

The Commission and the European Food Safety Authority (EFSA) could supervise the risk assessments conducted across Europe and coordinate the task of communicating the outcome of those assessments. A central organization could have more sophisticated ability to collate, assess, and distribute information than individual national authorities.

Read more here.

Alberto Alemanno is a guest instructor at the Institute for Food Laws and Regulations at Michigan State University. He is associate professor of law at École des Hautes Études Commerciales (HEC), Paris, adjunct professor of global risk regulation at Georgetown University Law Centre, and editor of the European Journal of Risk Regulation.

Training and an Integrated Food Safety System

Rightfully so, the FDA Food Safety Modernization Act includes language recognizing the importance of integrating state and local regulatory programs with the federal ones. Training is key to the success of creating an integrated food safety system.  On this topic, Joseph Corby, Gerald Wojtala, and Craig Kaml co-wrote the cover story of the April/May 2011 issue of Food Safety Magazine, titled, "Training in an Integrated Food Safety System: Focus on Food Protection Officials."

Global Food Law & Policy

The Summer Academy on Global Food Law & Policy ++ 25-29 July 2011 ++ Lake Como, Italy ++ few places available ++  www.lexxion.eu/conferences ++ Apply now!

Time to Modernize the Toxic Substances Control Act of 1976

High-profile media coverage of specific chemicals, like bisphenol A in infant bottles and can liners, creates anxiety about food regulation, but the problems of risky chemical exposure is much greater with non-food consumer goods. Chemicals added to food and from food contact materials are regulated as food additives under a relatively stringent review process under the Food, Drug, and Cosmetic Act.

On the other hand, non-food chemicals are regulated under the Toxic Substance Control Act of 1976 (TSCA), which is widely recognized as ineffective in protecting us from hazardous chemicals in the marketplace. In three decades of existence, TSCA has been used to regulate only five chemicals or chemical classes out of the thousands of chemicals that are in commerce. Under TSCA, chemical companies have no responsibility to perform premarket testing or postmarket follow-up of the products that they produce; in fact, TSCA creates disincentives for the companies to produce such data. Voluntary programs have been inadequate in resolving problems.

Senator Frank R. Lautenberg (D-NJ) introduced new legislation to modernize the Toxic Substances Control Act of 1976 (TSCA) and protect Americans from exposure to dangerous toxins. The law would for the first time require that chemical manufacturers demonstrate the safety of industrial chemicals used in everyday household products.  Senator Lautenberg launched a video on his Facebook and Twitter pages to build support for chemical safety reform and his "Safe Chemicals Act of 2011."  Watch it here.

Public Morals Proposed as a Grounds to Ban GMOs

Public morals, public order, "social policy objectives," and "historical heritage" are some of the reasons the European Commission has proposed as grounds for a national ban of genetically modified crops. The plan presented by John Dalli, the European commissioner for health and consumer policy, is to give governments greater leeway to ban GM crop cultivation for factors other than health or environmental grounds. The legal service of the Council of Ministers criticized the proposal as contrary to World Trade Organization (WTO) rules and the EU's own single market. More information is available from Jennifer Rankin, Growing GM crops 'could pose a threat to public order,' EuropeanVoice.com (Feb. 3, 2011).

FSIS Announces Final Rule for Interstate Shipment of State-Inspected Meat and Poultry Products

On April 19, 2011, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced a final rule that will broaden the market for smaller state-inspected plants. This voluntary cooperative interstate shipment program will allow select establishments to ship meat and poultry products, bearing an official USDA mark of inspection, across state lines.

Advance copy of the document, Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products (Apr 19, 2011), submitted to Office of the Federal Register is available here. 

FDA Announces Food Defense Mitigation Strategies Database

The new online database was developed by the Food and Drug Administration (FDA) for the food industry to help protect the food supply from deliberate acts of contamination or tampering. The Food Defense Mitigation Strategies Database (MSD) provides a range of preventive measures that companies may choose to implement to better protect their facility, personnel, products, and operations. Visit the Mitigation Strategies Database here.

Summer Academy on Global Food law & Policy

The third Summer Academy in Global Food Law & Policy will take place at Como Lake - Italy, July 25-29, 2011, at the beautiful Villa La Collina. A distinguished faculty from relevant food organizations (WTO, Codex, EFSA, EU Commission), industry (Coca Cola) as well as academia (Michigan, Bocconi, HEC Paris) will be animating cutting-edge discussions on the latest developments in global food governance, from food private standards to health claims, from US Food Modernization Act to novel food regulation. 

Among the those presenting are four faculty from the Institute for Food Laws and Regulations (IFLR) at Michigan State University: Neal Fortin, Professor at MSU and IFLR Director along with IFLR guest instructors Alberto Alemmano, Associate Professor of Law at HEC Paris, Gretchen Stanton,  Senior Counsellor at WTO, and Raymond O'Rourke, Barrister, Ireland.

For more information on the program and the faculty, please find the brochure here and more information here and here. Please don't hesitate to contact Nikola Bock (bock@lexxion.de) for more information.

Chief Justice Roberts Lectures AT&T on the Differences between Corn and Corny

In the recent FCC v. AT&T decision, the Supreme Court unanimously shot down the argument that corporations have "personal privacy" which allows them to withhold information under the personal privacy exceptions to the Freedom of Information Act (FOIA). (Justice Kagan did not participate.) AT&T argued that since Congress had defined "person" to include corporations, "personal privacy" rights should apply to a corporation. AT&T argued that the adjectival form of the defined word, personal, should refer to the defined word, person. 

Chief Justice Roberts gave AT& T a lesson on the the complexity and nuance of American English with some wry humor:

Adjectives typically reflect the meaning of corresponding nouns, but not always. Sometimes they acquire distinct meanings of their own. The noun "crab" refers variously to a crustacean and a type of apple, while the related adjective "crabbed" can refer to handwriting that is "difficult to read," Webster's Third New International Dictionary 527 (2002); "corny" can mean "using familiar and stereotyped formulas believed to appeal to the unsophisticated," id., at 509, which has little to do with "corn," id., at 507 ("the seeds of any of the cereal grasses used for food"); and while "crank" is "a part of an axis bent at right angles," "cranky" can mean "given to fretful fussiness," id., at 530.

In short, Chief Justice Roberts held that a corporation doesn't qualify for a "personal privacy" exemption under the law. 

"We trust that AT&T won't take it personally," he wrote.

The full opinion is available here.

EU BPA Ban Now in Effect

A ban prohibiting the manufacture in the European Union of baby bottles containing Bisphenol A (BPA) became effective March 1, 2011. BPA is an organic molecule that is used in the manufacture of polycarbonate plastics. Small amounts of BPA can be released from plastic containers into the food they carry if these containers are heated at high temperatures. According to scientific evidence, infants' ability to eliminate BPA is still building up during their first six months of life.
The ban of the manufacture of baby bottles with BPA was adopted in January (EU Directive (2011/8/EU) and entered into force on March 1. For more information, visit Alberto Alemanno's blog here.

‘Cheeseburger bill’ would block obesity lawsuits

Food Safety News reports that Minnesota's State Rep. Dean Urdahl, R-Grove City, has reintroduced legislation to bar Minnesotans from suing their favorite fast food restaurants for making them fat. The Personal Responsibility in Food Consumption Act, also known as the "cheeseburger bill," would prevent anyone in Minnesota from suing a fast-food restaurant for making them fat.

Twenty-three other states have passed similar laws according to the National Restaurant Association. Of course, anyone can sue anyone in America, but suits like this are summarily thrown out of court—even without hamburger shield laws. "You made me fat" lawsuits are going forward nowhere except on television. ABC's "Harry's Law" recently had a story with an overweight mother of several plump children who won $880,000 in an out-of-court settlement.

Black on Meat (or Lack Thereof) at Taco Bell

The Daily Show With Jon Stewart	Mon - Thurs 11p / 10c
Back in Black - Meat Edition
www.thedailyshow.com
Daily Show Full Episodes Political Humor & Satire Blog The Daily Show on Facebook

FDA's First Year Report on the Reportable Food Registry

The Food and Drug Administration's (FDA) report on the first year of the Reportable Food Registry states that the data, "represent an important tool for targeting inspection resources, bringing high risk commodities into focus, and driving positive change in industry practices–all of which will better protect the public health." Commodities that feature prominently in the Reportable Food Registry will receive additional FDA attention because the Food Safety Modernization Act mandates risk-based allocation of FDA resources.

Advancing Public Health Obesity Policy Through State Attorneys General

Jennifer Pomeranz and Kelly Brownell with the Yale Rudd Center for Food Policy & Obesity have authored "Advancing Public Health Obesity Policy Through State Attorneys General." The article refers to the role played by state attorneys general in public health policy on tobacco. They contend that attorney generals "can be leaders in formulating and effectuating obesity and food policy solutions." The article also takes note of recent actions by state attorney generals have taken regarding purported misleading labeling of food and beverage products.

Toxic Waste Candy?

FDA announced the recall of Toxic Waste® brand Nuclear Sludge® Chew Bars, all flavors due to elevated lead levels.

This puts a new twist on truth in labeling.

"Neal Fortin literally wrote the book on the nation's food laws"

CBS WLNS interviewed me regarding the FDA Food Safety Modernization Act.

The Food Safety Enhancement Act Passes the House

The U.S. House of Representatives passed Food Safety Enhancement Act in the final days of the 111th Congress. Now the bill heads for the desk of President Obama, who is expected to sign it into law. You may find a copy of the latest available GPO version of the text - this is not final - here, courtesy of Charles Woodhouse. This provisional text (240 pages) was extracted from the 2,000 pages of HR 3082. Alternatively, you may go here and scroll down to p. S10745).