Tracking the Food Safety Working Group - More or Less Legal Exposure For Food Sellers?
This week the Obama administration announced the launch of a new website for the recently formed food safety working group. Obama announced the formation of this group in March in the wake of the high-profile food safety issues surrounding PCA peanut products.
This website will assist in tracking the efforts of the working group. As discussed previously on this blog, this group is expected to make recommendations aimed at detection, awareness and government reorganization. Possible examples include increasing funding to states to monitor food-borne illness, combining FDA and USDA food safety efforts, reexamining mandatory recall authority, increasing retail enforcement and implementing more aggressive consumer warnings.
What is not clear is whether the working group will look beyond just detection, awareness and reorganization to bolder initiatives that may result in less consumer illness and less legal exposure for food sellers. Bolder initiatives could include funding for irradiation, consumer food safety education, and fast-track development and implementation of technology that can sample food products for whole colonies of microorganisms.
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A Reminder To Review Insurance
Law 360 has an article up this week titled “Coverage May Be Tricky For Food Recalls.” I am among the lawyers quoted in the article. For me, the takeaway is that any food company should have in place a strong team of insurance coverage counsel and brokers. Food companies need to ensure that they have in place the coverage they intend to have in place.
The article also suggests that the markets for recall insurance may be evolving and becoming more accessible. Recalls can be financially devastating. To the extent that recall insurance is affordable and provides relevant coverage, it should be considered.
Defending Liability in Foodborne Illness Outbreaks
I’m asked frequently about the “anatomy of litigation.” I plan to write more in this space on the topic. For now, some may find useful the slides from a presentation I gave recently on “Defending Liability in Foodborne Illness Outbreaks.” I discussed what I see as three prototypes of consumer claims and possible strategies to respond to each.
The Missing Menu Item: the Farm Products Exception
I just got the latest issue of Business Law Today, published by the Business Law Section of the American Bar Association. The cover has an intriguing title: "Food and the Law." The lead article has a title even closer to my heart: "Le Menu: the UCC and Food", written by Steven O. Weise of Proskauer Rose LLP. Steve is, in the interest of full disclosure, a friend, but in the interest of a full introduction, one of the most prolific writers and speakers on commercial law topics on the planet, someone who has been a mentor to many (myself included) and is engaging, witty and unbelievably smart.
Only he left out an item on his menu.
In his discussion of Article 9 of the Uniform Commercial Code, he left out section 9-320(a), which is called the "Farm Products Exception."
I think I know why he left it out: he practices in Los Angeles and California has never had the Farm Products Exception.
After the jump, more on the Farm Products Exception.
Continue Reading...Hamburg Confirmed by Voice Vote in Senate
Dr. Margaret A. Hamburg, President Obama's nominee to head the U.S. Food and Drug Administration, was confirmed by the U.S. Senate yesterday by a voice vote.
The Senate Health, Education, Labor and Pensions Committee had moved up her confirmation hearings because of the imminent threat of H1N1 influenza, and she sailed through both the heaings and action on the Senate floor with bipartisan accolades.
There are few things that would be better for the country than for those bipartisan accolades to continue to be earned by her during her entire tenure in this incredibly challenging job. We wish her luck.
Next Generation Sequencing for the Food Industry
More and more, it is becoming true that nothing drives detection and prevention of food-borne illness than technology (and, of course, with advancements in detection come potential increases in exposure to legal liability). No technological advancement may be more significant than Next Generation Sequencing ("Next Gen Sequencing").
I've recently had the opportunity to spend time learning about Next Gen Sequencing
with Dr. Andrew Benson, a genetic microbiologist at the University of Nebraska’s Department of Food Science and Technology. Dr. Benson has received large research grants to harness the power of Next Gen sequencing. If you’re interested in the field, take a look at this short video, where Dr. Benson explains the technology, and check out the information on the CAGE (Core for Applied Genomics and Ecology) website.
As described on the CAGE website, this Next Gen technology “allows a single machine to accomplish in 48 hours what used to take an entire room full of machines and an army of
staff a month to achieve.”
Dr. Benson and others at CAGE explain further that:
Having such a powerful diagnostic technique now challenges us to rethink completely how we might go about risk assessment. Instead of looking for a single “indicator organism” in a food sample, we can now look at the entire population of microorganisms in a food sample and ask if the community of organisms present is the expected species that normally occupy that food or if the sample contains numbers of unexpected species, and in particular those species that are unique to fecal or soil environments. Thus, our assessment of “risk” is now based on the entire population, including the most abundant species of fecal and soil communities. Because our assessment is based on the entire composition, multiple species that are unique to feces or soil can be used in the determination, making the assessment much more accurate and robust. Moreover, the assessment is not limited to “risk” as we can also determine if the microbial community in a food sample has shifted toward spoilage (which gives us shelf-life predictions) or is consistent with “good” organoleptic properties of the food. The list of applications goes on and on.
Discoveries using this technology are happening at astonishing speed. PFGE testing, now considered the "gold standard" and generic E.coli testing may soon seem old fashioned and crude.
USDA Says Continued Research Needed on Distillers Grains
The Nebraska Governor’s Conference on Ensuring Food Safety included a lively discussion on distillers grains and E. coli O157:H7. Dr. Jim Wells at USDA presented data that appears to show some correlation between certain levels of cattle-fed distillers grains and the levels of O157 that appeared in the hides of cattle. Recent research suggests that distillers grain does not increase the prevalence of O157 in cattle though it may increase the amount of the O157 in the cattle that already have the bug.
Some researchers are coming to believe that any issues surrounding distillers grains may be ameliorated by dietary supplements. Dr. Wells emphasized, however, that more research is needed. USDA believes that distillers grains are an important source of animal feed and appears committed to better understanding distillers grains and cattle nutrition.
How Not to Feed Airport Guards
An Interesting news item out of Kathmandu: 40 airport guards were taken sick with what appears to be dysentery all at the same time. The cause appears to be eating the same tainted food in the same employee cafeteria. According to the Malaysian national news agency:
All the police personnel used to share a cafeteria. Probably, they had eaten pumpkin curry and pickle of radish and potato unfit for human consumption which caused them food poisoning,
35 of the guards had been released from the hospital, and the airport, the only international airport in Nepal, employs 323 guards, but the question remains: can you allow all the guards on a single shift to eat the same food at the same time without knowing that it is absolutely, positively, safe? Otherwise, you're taking the risk that the bad pickle of radish can lead to more dire consequences.
We've all, I presume, seen Airplane! You'll be hoping that someone picked the right day to give up pumpkin curry.
Are Organic Foods Safer? Will Consumers Continue to Favor Organics?
Nobody disputes that consumers have a favorable view of organic certification in foods. Consumers generally believe that organic foods are healthier, and many believe they taste better. Yet, among food scientists, uncertainty prevails as to whether organics are safer, especially raw fruits and vegetables.
Absence of synthetic fertilizers is a primary distinction between organic and non-organic foods. And, from a safety standpoint, the absence of pesticides is the only provable claim that organic foods are healthier. But does the absence of one hazard imply the existence of another?
The prevailing pesticide substitute for organic foods is manure or composted manure. Dangerous pathogens such as E. coli O157 reside in manure. Some guidelines exist for composting manure. Unfortunately, as I learned recently in a presentation by Dr. Francisco Diez-Gonzalez at the University of Minnesota Food Science Department, these guidelines were written a decade ago, before science began to understand the prevalence of E. coli in the environment.
Science now understands that E. coli O157, for example, can persist for years in soil, let alone a more rich environment like manure. In some cases, it may be virtually impossible to rid of an environment of E. coli O157, short of treatment with non-organic substances such as tear gas or asphalt.
Outside of the 2006 spinach outbreak, there have been few food-borne illness outbreaks associated with organic fruits or vegetables. As organic farming continues to grow and detection of food-borne illness increases, the only question is how long it will be until another well-publicized outbreak. When it happens, will consumers continue to believe organic foods are safer? Will the industry be ready with evidence that proves the benefits of organic farming outweigh its risks?
USDA (FSIS) Becoming More Aggressive
At the recent Nebraska Governor’s Conference on Ensuring Food Safety, Dan Engeljohn from FSIS (USDA) announced a number of significant policy changes. FSIS’s changes in part are consistent with those previously announced under the last administration and in part represent the Obama administration’s new priorities. Those include (among other things):
1. Supermarket Enforcement – FSIS has not emphasized retail (i.e., supermarket) surveillance and enforcement since the early 1990s. FSIS perceives an increase in beef processing (e.g., grinding) at the retail level. As discussed previously on this blog, FSIS also perceives a failure by many retailers to maintain proper production logs. Supermarkets should expect the following:
A. Unannounced FSIS inspectors will be directed to pull samples on the spot if an inspector walks into a supermarket without good recordkeeping or with unsanitary conditions.
B. New regulations will be aimed specifically at retailers.
2. Non-O157 STECS to Become Adulterants – FSIS appears to be moving aggressively toward declaring at least certain non-E. coli O157 Shiga Toxin E. coli (STECs) as adulterants. FSIS is targeting strains known as E. coli O26, 103, 111, 121, 45, and 145. These strains account for 82% of non-O157 strains detected by PulseNet. Dr. Engeljohn explained that FSIS is looking carefully at these strains and is heading toward their regulation. But he commented that so far information collected about those infected with non-O157 STECs shows that these strains may be less virulent than O157.
3. Attention to Primal Cuts – At least two factors are driving FSIS to develop stricter regulation of primal cuts. First, FSIS learned in the last couple of years that needle-tenderizing injections of steaks are now commonplace in the industry. Second, FSIS is concerned about bench trim.
4. More Aggressive Release of Information to the Public – Dr. Engeljohn also indicated that FSIS will be more aggressive in releasing outbreak information sooner. No longer will FSIS await the kind of confirmation it previously required before requesting recalls or going public with outbreak information.
While the Obama administration has yet to announce an appointment for the FSIS’s Under Secretary of the Office of Food Safety, Dr. Engeljohn indicated that these initiatives are only the beginning. FSIS will be more aggressive on perceived issues of food safety.
FDA Warning to General Mills: Cheerios is a Drug
The U.S. Food and Drug Administration is taking issue with claims that Cheerios cereal can lower cholesterol.
In a letter to General Mills, the FDA says that statements made on Cheerios packaging like the claim that the cereal is “clinically proven to help lower cholesterol” make the product a drug under federal law. The agency suggests that General Mills should file a new drug application with the FDA if it wants to keep making these claims on Cheerios boxes. The FDA also noted concerns with statements made on a General Mills-sponsored website regarding the benefits of eating whole grains.
The Wall Street Journal is reporting that a General Mills spokesperson said the company will work with the FDA to reach a resolution regarding Cheerios labeling.
The Pistachio Industry Follows the Peanut Industry
When the peanut butter recall hit, the American Peanut Butter Council issued a list of the items that were not affected by the recall, which was isolated to the products of now-defunct Peanut Corporation of America.
The similar, though less-publicized, pistachio recall has also been isolated to pistachios from a single company, Setton Farms. And the Western Pistachio Association has developed a website, pistachiorecall.org, dedicated to listing products unaffected by the recall. According to the FAQ on the site, the products listed on the unaffected products list are those that producers and distributors indicated on a signed affidavit did not include pistachios from Setton Farms.
Setton Farms International Inc. and Setton Pistachio of Terra Bella, Inc. did finally put the news of the recall on their website, along with messages to their wholesale customers. The differences between the pistachio and peanut outbreaks come down to two things, which bode well for Setton Farms' future. First, there have not only been no reported deaths from pistachios, there have been no cases of salmonellosis. Second, an inspection of Setton Farms' other plant, in Commack, New York, by New York State authorities, indicated no presence of salmonella.
Finally, the FDA has a pistachio widget, too.
FDA Seeks Largest Budget Increase in Agency's History
The Food and Drug Administration is seeking to increase its budget for Fiscal Year 2010 by nearly 20 percent more than FY 2009 – to $3.2 billion. The Washington Post reports that the increase is the largest in the agency’s history.
The FDA’s spending request includes $259.3 million to be devoted to the “Protecting America’s Food Supply” initiative. The agency plans to, among other things, strengthen the safety and security of the food supply chain, increase food inspections, and reinspect food facilities that fail to meet FDA’s safety standards. The Associated Press reports that the FDA’s proposed budget would put 222 more food inspectors in the field, for a total of 1,022. A summary of the FDA’s FY 2010 budget is available here.
Judge Denies Class Action Status in McDonald's French Fry and Hash Brown Litigation
A lawsuit claiming that McDonald’s deceived the public about ingredients in its french fries and hash browns will not proceed as a class action. A federal judge in Chicago has denied the plaintiffs’ motion for class certification, characterizing the proposed class and subclasses as “too indefinite and overbroad.”
According to the court’s opinion, the potato suppliers who provide McDonald’s with its french fries and hash browns par-fry the potatoes in oil made of 99 percent vegetable oil and one percent natural beef flavor. The beef flavor is partly made from wheat bran and casein (a dairy product). McDonald’s restaurants then fry the potatoes in 100% vegetable oil prior to serving the products to customers. Plaintiffs allege that McDonald’s falsely claimed its french fries and hash browns were gluten, wheat, and dairy-free. They say that they never would have purchased the potato products if they knew that the fries and hash browns were partially fried in oil containing wheat bran and casein. McDonald’s corrected its disclosure in 2006.
The plaintiffs proposed a class consisting of all persons residing in the United States who purchased McDonald’s french fries or hash browns between February 2002 and February 2006 and who, at the time of purchase, had been diagnosed with celiac disease, galactosemia, autism, and/or wheat, gluten, or dairy allergies.
In rejecting class certification, U.S. District Judge Elaine Bucklo noted that none of the plaintiffs has suffered any physical injury from eating the potato products; indeed, she noted that “plaintiffs testified in their depositions that they were quite satisfied with the Potato Products they consumed.” Additionally, Judge Bucklo noted that proving economic damage would be an “evidentiary headache” because the court would be required to review potentially millions of letters proving plaintiffs’ medical diagnoses and the damage to each potential class member would be nominal: between $1.00 and $1.50. Finally, the court ruled a nationwide class action would be unmanageable because state laws at issue in the case vary too much to apply to plaintiffs from across the country.
The case is In re McDonald’s French Fries Litigation, MDL No. 1784.
Salmonella in a Different Language
When the news of salmonella in something as American as peanut butter needs to get out, spreading the word is fairly routine. What happens when salmonella rissen is found in white pepper distributed mainly to Chinese and other Asian restaurants on the west coast?
Union Internatonal Food Company of Union City, California has voluntarily recalled dry spices after 42 cases of salmonella rissen have been reported in California, Oregon, Washington and Nevada. White and black pepper are particularly suspect. The company's products were marketed almost entirely to restaurants in those states and Arizona.
But it is likely that many of the people most likely to using the products do not have English as their first language. Accordingly, the FDA and Union International itself issued some of their material in Chinese, including this complete notice.
FDA Commissioner Nominee Faces Confirmation Hearing
Dr. Margaret Hamburg, President Barack Obama’s nominee to oversee the Food and Drug Administration, is appearing before a U.S. Senate committee this afternoon regarding her nomination. The confirmation hearing before the Senate Health, Education, Labor and Pensions Committee began at 2:00 p.m. ET. Streaming video is available here.
The Associated Press is reporting that, if confirmed, one of Hamburg’s first tasks will be overseeing development of a vaccine for the H1N1 influenza virus. In Hamburg’s opening remarks to the Senate committee that were made available to reporters earlier today, she also noted that food safety will be among her top priorities. “Important steps must be taken to better protect the nation’s food supply from farm to form,” Hamburg said.
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