FSIS Tells Ground Poultry Producers to Reassess Their Food Safety Plans

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a press release on Wednesday, December 5, 2012, announcing that companies producing raw ground chicken and turkey and similar products will be required to reassess their sanitation procedures and pathogen control plans over the next few months. Specifically, over the next 90 days, producers of raw ground chicken and turkey must conduct a thorough examination of its current Hazard Analysis and Critical Control Points (HACCP) to confirm its ability to identify hazards and better prevent foodborne illness. After the 90 day period, FSIS inspection program personnel will begin verifying that establishments that manufacture raw ground turkey or chicken products have indeed reassessed their HACCP plans.

FSIS will be documenting whether establishments made any changes to their HACCP plans in response to the required reassessment and will later evaluate those changes. Later, the agency intends to publish guidance materials for the industry on best practices to reduce Salmonella in ground and comminuted (further processed by mechanical separation or deboning and chopped, flaked, minced or broken down) poultry.

In making this announcement, officials at FSIS are hoping to lower the prevalence of Salmonella contamination within these types of products. This attention to the ground poultry product industry with a focus on Salmonella comes as a response to recent outbreaks that have sickened hundreds across the country in the past few years. Just in the last two years there have been two major Salmonella outbreaks associated with ground poultry products that affected consumers nationwide.

In conducting these reassessments, FSIS is advising companies to look at, among other things, the following:

[E]stablishments should evaluate the adequacy of their sanitation procedures for processing equipment, including grinders, blenders, pipes, and other components and surfaces in contact with the product. Thus, Sanitation SOPs, other prerequisite programs, or HACCP plans should address procedures that ensure that all slaughter and further processing equipment, employee hands, tools, and clothing, and food contact surfaces are maintained in a sanitary manner to minimize the potential for cross contamination within and among lots of production. In addition, FSIS expects establishments to ensure that slaughter and dressing procedures are designed to prevent contamination to the maximum extent possible. Such procedures should, at a minimum, be designed to limit the exterior contamination of birds before exsanguination, as well as minimize digestive tract content spillage during dressing process.

Other FSIS recommendations include validating cooking instructions, examining lotting practices that minimize contact between lots, and requiring suppliers to show that they have used a Salmonella intervention step.

In FSIS’s notice, the agency also announced that it will be expanding the Salmonella verification sampling program to include other raw comminuted poultry products, in addition to ground product; it will be increasing the sample size for laboratory analysis from 25 grams to 325 grams to provide consistency as the Agency moves toward analyzing samples for Salmonella and Campylobacter; and it will be conducting sampling to determine the prevalence of Salmonella in raw comminuted poultry products.

Although these new procedures are intended for producers of ground or comminuted chicken and turkey products, FSIS is recommending that manufacturers of comminuted products derived from cattle, hogs, and sheep or comminuted poultry products derived from poultry other than chicken or turkeys also consider assessing whether their food safety systems present food safety vulnerabilities.

The Great Egg Recall of 2010: Another Review of Lessons Already Taught

You have probably heard about the great egg recall of 2010, which has required Wright County Eggs of Galt, Iowa to recall an ever-growing number of shell eggs because of fears of salmonella enteriditis

An interesting issue here is the non-overlapping jurisdiction of USDA and FDA over eggs in the shell.  According to the FDA:

Generally, USDA is responsible for egg safety at what are called breaker plants or egg products processing facilities. In these facilities eggs are broken and pasteurized. FDA is responsible for shell egg safety and egg products once they leave the breaking facility.

Interestingly, while this outbreak is easily found on the FDA's website and at FoodSafety.gov, there is nary a word on the USDA home page.

The FoodSafety.gov page about safely handling and dealing with eggs is a good place to start for consumers worried about their own eggs. 

We also repeat the advice we have collected from previous outbreaks:

 

CDC Sees "Sustained Decline" for 2009 in Reported Rates of Food-Borne Illness, but Is This Real?

A somewhat surprising report out this week by the CDC reports for 2009 "sustained declines in the reported incidence of infections caused by Campylobacter, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC) O157, Shigella, and Yersinia." Only Vibrio seems on the rise. For E.coli O157:H7 infections, the CDC claims its "Healthy People 2010 target" was met.

The chart below shows the trend lines since 1996 in the reported incidence for many of these pathogens:

FIGURE 1. Relative rates of laboratory-confirmed infections with Campylobacter, STEC* O157, Listeria, Salmonella, and Vibrio compared with 1996-1998 rates, by year -- Foodborne Diseases Active Surveillance Network (FoodNet), United States, 1996-2009†
 

While the news sounds good,(see Rick Goldfarb's detailed analysis of the implications of the 2009 report for context) other factors could be at play that give only the appearance of a safer food system. One explanation can be found in a CDC report from 2009 that "in 2009, 10% fewer epidemiologists were working in state health departments than in 2006." The data the CDC has is only as good as the capacity the state health departments have on the ground to collect it. Fewer epidemiologists means fewer investigated food-borne illnesses. Fewer investigated food-borne illnesses means fewer reported food-borne illnesses. Fewer reported food-borne illnesses, therefore, does not necessarily mean the existence of fewer food-borne illnesses.

The Great HVP Recall of 2010: A Review of Lessons Already Taught

As Ken noted last week, there has been a widespread recall of products containing hydrolized vegetable protein (HVP), a flavor enhancer, after salmonella Tennessee was discovered in product manufactured by Basic Food Flavors of North Las Vegas, Nevada.  Consumers, who may have been unaware of the existence of HVP, are starting to learn how pervasive an ingredient it is in packaged and processed foods.  The FDA has a handy list of products so far affected by the recall.  There's a widget, too.   

So far, no one has been reported to have been made sick or died as a result of this outbreak. 

The FDA warns consumers "Remember to follow cooking instructions on all foods", except that many of the foods that contain HVP are not ones consumers cook.  Included are salad dressings, ready to eat meal products, sauce and marinade mixes and snacks.  I don't think there's a way for a consumer to cook a pretzel. 

This outbreak is a good excuse to reiterate some of our advice from prior outbreaks, like the 2008 tomato outbreak and the 2009 peanut and pistachio outbreaks. 

As Professor Moody would say, "Constant vigilance."

 

PCA Investigation: Anatomy of A Recall

FDA has a short video "anatomy of a recall" about the investigation of the Salmonella outbreak and recalls associated with Peanut Corporation of America (PCA). Anyone interested in learning how the federal government  (with the help of Minnesota's "Team Diarrhea") goes about a food borne illness investigation and recall should take a look.

 

 

Video From Governor's Conference on Ensuring Food Safety

University of Nebraska has posted video on its website from the entire three days of the 2009 Governor’s Conference on Ensuring Food Safety. You can view my presentation on Defending Liability in Foodborne Illness Outbreaks. More important, you view the presentations of Dr. Andrew Benson and the other scientists who offer fascinating insights into the latest developments driving the science of food safety.

Monty Python and the Food Recalls

One of Monty Python's most imitated sketches was "The Four Yorkshiremen."  Even if you've never seen it, it will be instantly recognizable to you.  It's the one where four men sit around talking about how tough they had it as kids, compared to how kids have it today.  One starts by complaining about how small his house was, and another exclaims, "You had a house?"  Eventually, the last one claims to have been roused from bed half an hour before he went  to bed, worked 27 hours a day and paid for the privilege and then was murdered every night when he got home. 

I was thinking about this sketch as I was contemplating how different from the last food recall about which I blogged, involving tuna in New England, was from the painfully slow recalls involving the salmonella finding that has led Plainview Milk Products Cooperative to recall the last two years of its products.  As you might recall, the last recall involved fresh tuna steaks sold to three New England supermarket chains over four days before the problems were identified.  By this time, most of the food subject to the recall had probably been consumed and the recall required only publicity in a limited area for those who might have frozen the steaks rather than eaten them fresh.  Without denying the difficulties that North Coast Sea-Foods might have encountered in that recall, or the suffering of anyone who got scombroid poisoning, as a recall goes, they, in the words of Monty Python, had it easy.

The Plainview Milk Products Cooperative and everyone who bought from them, on the other hand, have it anything but easy, and the fact that almost every day new products are added to the recalled list demonstrates this. 

It all started with a package of powdered milk shake mix.  A USDA test showed there was salmonella in the powder.  Plainview was the supplier of a main ingredient in the powder.  Although tests of its products have uncovered no salmonella, there was salmonella found on some equipment in Plainview's plant.  This triggered the recall.  No persons have been found who have been made ill by any of Plainview's products.

Plainview does not sell products to consumers.  However, as the recall has unfolded, the number and scope of products that are sold to consumers that incorporate Plainview's products has been shown to be huge.  Included are:

  • Instant non-fat dry milk
  • Instant oatmeal
  • Instant gravy
  • Popcorn
  • Instant cocoa
  • Sports drinks
  • Instant milk shakes

Products with familiar names like Malt-O-Meal and Land O'Lakes are covered, as are numerous private label products from companies like Meijer, Kroger, Stop and Shop and Piggly Wiggly

Because the products are the kind that are shelf-stable, and the recall covers two full years, even after all the recalled foods have been identified, getting consumers to search pantries for them will be difficult.  Indeed, a lot of these products were incorporated into emergency kits, the kinds of things you don't open until needed. 

Another place where the powder can be found is in Meals-Ready-to-Eat, the famed MREs of the miltary.  In other words, U.S. soldiers in Iraq and Afghanistan are having to toss out their vanilla, chocolate, strawberry and stawberry-banana milkshakes, according to Stars and Stripes.  MREs are also used by FEMA and by campers

As Ken noted recently, the two highest priorities on the Obama Administration's list for the FDA are Salmonella and a national traceback and response system.  What the Plainview situation indicates is that, to be effective, the tracing system may need to go in both directions.  It didn't take the FDA long to find that Plainview's products were incorporated into the milk shake mix, but it is taking a very long time to find all the products into which the same set of ingredients--including  nonfat dry milk, fruit stabilizers, whey protein, and gum products--have also been incorporated.   

The implications of such a system, however, are huge.  Here are just a few: 

  • There is an identity between food safety information and confidential commercial information in terms of the relations between suppliers, manufacturers, distributors and retailers.  How will this be kept confidential?  Who will be trusted to keep it confidential?
  • Who pays for the system, and who controls its expenses? 
  • What is the end point on the origination side?  Does every farmer have to keep track of all the inputs into its produce? 
  • Manufacturers may use many sources of fungible goods; will they be required to trace these?  Who pays the capital cost of changing from one big hopper to four small ones?

Finally, I would be remiss without mentioning the point made by Kimberly Lord Stewart, editorial director of Functional Ingredients Newsletter.  As Ms. Stewart points out, there is no proof that the salmonella found in the milkshake powder came from the Plainview ingredients, and there are nine other ingredients in the powder made by others. 

As Ms. Stewart says,

The Plainview situation has hints of the salsa recall, which initially implicated tomato growers, then salsa makers, only to find out the source of contamination was jalapeños. Traceability is a complicated and looming issue for processed foods. Looking for a needle in a haystack is easy compared to tracking down 9 lesser ingredients in DairyShake blends or multiple ingredients in salsa.

 Or, as the late Graham Chapman would say, "Luxury." 

Future of Food Litigation and Obama's Food Safety Working Group

President Obama’s Food Safety Working Group announced its Key Findings on July 7. Three groups of initiatives were announced: 1) Salmonella, 2) National Traceback and Response System, and 3) Improved Organization of Federal Food Safety Responsibilities. All of these represent major shifts in food policy. Coming changes will impact nearly every part of the nation’s food supply.

Despite Obama’s stepped-up food safety agenda, the question of how these changes will affect food-borne illness litigation remains. Bill Marler in a recent blog post reacting to the July 7 Key Findings says, “I really may live to see the government ‘put me out of business.’” No doubt that many of Obama’s initiatives will improve food safety. But will it eliminate food-borne illness and accompanying litigation? Not likely.

Many food companies today follow food safety precautions that exceed anything proposed by the Obama administration or Congress. Yet those same companies continue to experience food-borne illness outbreaks and are targets of the plaintiffs’ bar. E. coli, Salmonella, and other pathogens are persistent in the environment and successful at Darwinian evolution. In some sense, the pathogens that are the source of food-borne illness always seem at least one step ahead of the law.

Crystal ball: Obama’s initiatives will lead to a safer food supply but will also help the government detect more outbreaks that previously went undetected. Undetected outbreaks rarely lead to litigation; detected outbreaks almost always lead to litigation. Growth in food-borne illness litigation, therefore, should continue to accelerate.

Why Are Food-borne Organisms Associated with Beef?

 USDA’s Be Food Safe Twitter Feed circulated its Fact Sheet titled “Beef . . . from Farm to Table.” First published a few years ago, this might be of interest to businesses involved in the sale, marketing, labeling, and/or packaging of beef. The article is a helpful primer on the history of beef, current industry practices, USDA’s role in inspection, consumer trends, cooking times, storage times, and food-borne illnesses associated with beef.

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 Product Recall List

Pistachio Product Recall 2009. Flash Player 9 is required.FDA pistachio product Recall Widget. Flash Player 9 is required. Visit http://www.accessdata.fda.gov/scripts/pistachiorecall/index.cfm to search for pistachio product recalls for more information.

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 and CDC Warn of Salmonella in Raw Sprouts

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are recommending against eating raw alfalfa sprouts because of potential salmonella contamination.

According to the FDA, the salmonella contamination appears to be in seeds for alfalfa sprouts. As of yesterday, 31 cases of illness with Salmonella Saintpaul have been reported to the CDC. The reported cases are in Michigan, Minnesota, Pennsylvania, South Dakota, Utah, and West Virginia. The FDA cautions that the number of infected people may rise because some illnesses have not yet been confirmed with laboratory testing.

The FDA believes this outbreak may be linked to an outbreak from earlier this year. Its initial investigation traces the contaminated raw alfalfa sprouts to multiple sprout growers in multiple states. Additional details are available here.

Food-Borne Illness: Glass Half-Empty or Half-Full?

The Centers for Disease Control has issued a study of the incidence of food-borne illness in ten states.  The study, by the Foodborne Diseases Active Surveillance Network, known as "FoodNet", in general concludes that food-borne illness has not significantly either increased or decreased in the United States since 2004, after substantial gains in food safety from 1996 to 2004. 

The Associated Press article on this, by Mike Stobbe, is entitled, "CDC: US food poisoning cases held steady in 2008."  This is an appropriately neutral headline.  What is interesting is how different media outlets have dealt with the story

Reuters, in an article by Julie Steenhuysen, uses the headline, "U.S. making little progress on food safety."  She emphasizes in the lede the use in the study of the word "plateaued."  Lyndsey Layton's Washington Post article is headed, "CDC Study Finds Some Food-Borne Illnesses Rising in U.S."  The article's lede actually says that the rate has "remained stagnant", and nowhere in the article is any mention made of any specific diseases whose rates have risen (the article instead clumps together some where rates have either risen or remained constant, without distinguishing which are which).  The UPI headline is "Little Progress in U.S. food safety", similar to the New York Times's "U.S. Food Safety No Longer Improving, Data Show". 

On the rosier side, the Wall Street Journal's Jacob Goldstein blogged with the headline, "Reality Check on Foodborne Illness Rate." Goldstein takes the position that the lack of an increase given the wide publicity to certain outbreaks is an indication that things are doing well.  It is not clear, however, whether Goldstein understood, as the Washington Post article reported,

The data did not include the ongoing national outbreak of salmonella illness linked to peanut products that began in late 2008 but peaked in the early months of 2009, with nearly 700 people sickened and nine killed.

So what does the report actually say?

 

Let's start with the report's own discussion of its own limitations.  To start with the title of the report is "Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food --- 10 States, 2008."  The word "Preliminary" is not featured in any of the above headlines.  Many of the articles do point out that the report is based on data from ten states, covering about 45 million people.  The report itself lists four important limitations to the validity of its data, none of which are discussed sufficiently in any of the media reports:

First, because FoodNet relies on laboratory diagnoses, changing laboratory practices might affect the reported incidence of some pathogens. For example, fewer laboratory-confirmed infections might be reported as a result of increased use of nonculture tests. Second, many foodborne illnesses (e.g., norovirus infection) are not reported to FoodNet because these pathogens are not identified routinely in clinical laboratories. Third, differences in health-care seeking behaviors between age groups might contribute to a much higher incidence of reported illness in certain age groups (e.g., young children and older persons) (10). Finally, although the FoodNet population is similar demographically to the U.S. population, the findings might not be generalizable.

That's a lot of noise.  In particular, the fourth issue, whether it is appropriate to generalize from the data in these ten states to the rest of the country, is critical.  FoodNet argues that its data are from states that, other than an underrepresentation of Hispanics, are not significantly different from U.S. census data for the entire country.  This misses, however, what I think is the more critical question, which is whether the participation of these ten states in FoodNet indicates something different about the public health organizations of those states compared to the remaining states.  It is possible that the other states are putting their funds into inspection and food safety education instead of statistics gathering, but it may be just as likely if not more that the states who participate are the ones whose public health organizations are the most modern and vigilant.  What this might mean for trends is quite problematic.  The ten states may have plateaued because they're doing all they can while there is progress elsewhere, or there may be worse conditions elsewhere that are not being reported.

The report covers ten enteric pathogens:

The report indicated only one increase, that for salmonella, which it stated was "not significant."  In addition, among salmonella serotypes, one (Saintpaul) increased significantly.  We previously reported that saintpaul was the main pathogen found in bad tomatoes in 2008.  Of the others, one increased some and one decreased some and the seven others didn't change. 

What is significant is not so much that the reports of these diseases among the ten states are increasing or decreasing (they appear to be doing neither) but that we are nearly at 2010, when the national health goals contained in the federal government's "Healthy People 2010" program are supposed to be met.  Salmonella incidence is supposed to be at 6.8 per 100,000 people by 2010 and it was at 16.2 in 2008, which is a long way away. 

The other critical lesson from the report is that the apparent plateauing has occurred despite a number of important public health measures that have been taken in the period studied.  These include the FSIS's salmonella initiative, the FDA's lettuce and spinach irradiation program, and the FDA's and Customs and Border Patrol's efforts relating to screening food imports

I imagine that the FDA and the CDC and the various state public health agencies are feeling more than a little like Hans Brinker right now.  However, I wonder if what is really going on, which the report doesn't talk about at all, is a combination of three things:  (1) the low-hanging fruit has been taken care of to a great extent; (2) some of the measures the reports touts were not completely implemented due to funding and other constraints (the importation program would be where I would start in studying this); and (3) pathogens evolve. 

Now let me let you in to what wasn't reported:  the report doesn't look too different from last year's.

Here is the critical paragraph from this year's report:

Despite numerous activities aimed at preventing foodborne human infections, including the initiation of new control measures after the identification of new vehicles of transmission (e.g., peanut butter--containing products), progress toward the national health objectives has plateaued, suggesting that fundamental problems with bacterial and parasitic contamination are not being resolved. Although significant declines in the incidence of certain pathogens have occurred since establishment of FoodNet, these all occurred before 2004. Of the four pathogens with current Healthy People 2010 targets, Salmonella, with an incidence rate of 16.2 cases per 100,000 in 2008, is farthest from its target for 2010 (6.8). The lack of recent progress toward the national health objective targets and the occurrence of large multistate outbreaks point to gaps in the current food safety system and the need to continue to develop and evaluate food safety practices as food moves from the farm to the table.

Here is the corresponding paragraph from last year's report:

Although significant declines in the incidence of certain foodborne pathogens have occurred since 1996, these declines all occurred before 2004. Comparing 2007 with 2004-2006, the estimated incidence of infections caused by Campylobacter, Listeria, Salmonella, Shigella, STEC O157, Vibrio, and Yersinia did not decline significantly, and the incidence of Cryptosporidium infections increased. The incidence of Salmonella infections in 2007 (14.92 cases per 100,000) was the furthest from the national target for 2010 (6.80 cases), and only infections caused by Salmonella serotypes Typhimurium and Heidelberg declined significantly.

There's really not a lot of news here, and if there is any, it's that the closeness of 2010 is making those goals seem harder to achieve.  When you actually look up the meaning of "plateau" in this context, Merriam-Webster's actually has two almost contradictory definitions.  Definition 2(b) is "a relatively stable level, period or condition."  Definition 3 is, "a level of attainment or achievement."  Neither one has a negative connotation.  In these times, even stability seems like a wonderful goal.  Attainment or achievement sound wonderful. 

 

 

California Lawmakers Announce Proposed Food-Safety Reforms in Wake of Pistachio Recalls

As pistachio recalls continue to be announced in the wake of salmonella-tainted pistachios from Setton Farms, two California lawmakers this week announced legislation that is expected to strengthen food-safety standards in that state.

The bill to be introduced in the California State Assembly by Assembly Speaker Karen Bass and Assemblyman Mike Feuer is expected to require detailed safety plans from food processors, periodic testing of food at California food processing facilities, and requirements for food processors to report to state authorities any positive tests for a dangerous contaminant within 24 hours.

A video of Assemblyman Mike Feuer’s announcement is available below.  Meanwhile, the FDA continues to update its list of recalled products.

 

The Pistachio Recall: More Salmonella

The FDA and the California Department of Public Health announced on March 30 the recall of pistachios from Setton Farms, which have been linked to a discovery of salmonella originally identified by Kraft Foods in Back to Nature Trail Mix.  The FDA has a list of recalled products, but that may grow. 

Obviously, we have been through this drill before.  It is interesting to note the reactions of different involved parties.

As the links above show, both the FDA and the Calfiornia Department of Public Health note the recall on their home pages.  I would note that the FDA's message is easier to find, though.

Kraft notes it as a "Consumer Alert" in the upper right hand corner of their home page.  It's not particularly prominent, but it is visible.

Setton Farms, at least as of the time this post was entered, did not note the recall on its home page at all. 

Given that information about a nationwide recall of their pistachio products is available on Fox Business, the New York Times, Huffington Post and pretty much any other news outlet, you would think that Setton Farms would have had someone update their website and put this in big red letters. 

Nestle's Makes the Very Best Peanut Decision

On Thursday, March 19, the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee held another hearing on Peanut Corporation of America and the Salmonella outbreak.  A focus of the hearing was the different choices made by Nestle USA, which had refused to buy PCA peanuts, and the companies testifying at the hearing, including Kellogg and King Nut, which had. 

Nestle, when considering buying peanuts from PCA, had sent its own inspectors to PCA's plants.  They found, according to a report of the hearing in the Washington Post, some rather damaging items:

rat droppings, live beetles, dead insects and the potential for microbial contamination

Nestle, not surprisingly, declined to buy from PCA. 

At the hearing, witnesses from Kellogg and King Nut were questioned as to why they had not done their own inspections, instead relying on inspections by AIB, the American Institute of Baking, which were paid for by PCA, and which apparently tipped PCA about when it was coming

The question nobody seemed to ask--and no one from Nestle was at the hearing--was why Nestle could not have made the results of its inspection public at the time?  If there are "rodent droppings in the break room cabinets", and the company is selling peanuts to other members of the general public, just not through Nestle, isn't this something that should be made known to someone?

One answer lies in the fear of the various torts that come under the heading of "trade libel."  Nestle is a big company, and even though it presumably trusts its inspectors (and makes important business decisions based on their reports), it must recognize that it is a potential "deep pocket" for lawsuits.  Thus, to report publicly what its inspectors found, or even to make that information avaiable to others in the food industry, is to risk a major lawsuit. 

The flip side should also be considered.  If you are PCA, and someone broadcasts to the world that you have rat droppings in your break room cabinets, you are likely to experience significant losses, regardless of whether the report is true, and whether the presence of rat droppings in your cabinets affects the actual safety of your food.  What we do know is that in 2008 PCA began shipping peanuts that killed people.  The rat droppings found in the 2002 Nestle inspection presumably had nothing to do with those deaths, nor are we aware of any deaths or illnesses from PCA peanuts in the interim.  Finally, we do not of course know whether there are other suppliers Nestle or others who conducted their own inspections rejected, and what they did with the news of rejection.  Nestle, for instance, didn't write off PCA when it rejected it in 2002; it checked out another PCA facility in 2006 (and came to similar conclusions). 

Then there is the question of what contractual rights and obligations existed between PCA and Nestle.  Did PCA require Nestle to sign a non-disclosure agreement when it allowed it into the plants?  Any well-advised company would require such an agreement at the very least to protect proprietary technology.  Thus, Nestle may have been contractually bound not to reveal the results of its inspections.

As food safety legislation is being considered, the issue of tort liability and the right to use contracts to silence someone who knows about your dirty facility should be faced.  It is not as simple as "all inspections should be public", but it is also unlikely to remain as business as usual.  We publicize the results of government restaurant inspections without putting all restaurants that fail to pass inspection out of business.   

Georgia House Unanimously Passes Food Safety Bill; Kellogg CEO Calls for Food Safety Reforms

Update to today’s earlier post: the Georgia House of Representatives unanimously passed a bill today that would strengthen food safety laws in Georgia. The Georgia House and Senate now will resolve minor differences in the proposed legislation and send a final version to Georgia Gov. Sonny Perdue for his signature.

Also today, the AP reports that the chief executive of Kellogg Co. is urging food safety reforms, including written safety plans for all food companies and annual inspections of facilities that make “high-risk foods.” The AP article notes Kellogg lost $70 million worth of peanut products in the recent salmonella outbreak linked to Peanut Corporation of America.

Georgia is One Step Closer to Tough New Food Safety Law

The Georgia House of Representatives today considers proposed legislation to strengthen food safety rules in that state.  Among other things, Senate Bill 80 includes a provision that would require food makers to alert state inspectors within 24 hours if a plant’s internal tests show products are tainted.  Experts say no other state has such a rule.

The bill already has passed the Georgia Senate.  House approval would mean Georgia Gov. Sonny Perdue soon could sign the bill into law.

The bill was introduced following the salmonella outbreak linked to Peanut Corporation of America.  Investigators say the company knowingly shipped salmonella-laced products even after PCA's internal tests showed the products were tainted.  State law did not require the company to share those test results.

PCA Files for Chapter 7 Bankruptcy

It will come as no surprise that Peanut Corporation of America has filed for bankruptcy protection in the Western District of Virginia. 

According to the bankruptcy filing, PCA claims to have debts of only between $1 and $10 million, and between 100 and 199 creditors.  My colleagues in our Business Finance and Insolvency group tell me there is little penalty for any inaccuracies in these particular boxes on the cover sheet to a bankruptcy filing.

Two points are critical:  they filed for Chapter 7 liquidation, not Chapter 11 reorganization.  While voluntary Chapter 7 filings are not typical, they are less unusual than you might think. 

The other point comes from a box checked on the cover sheet.  It reads, "Debtor estimates that, after any exempt property is excluded and administrative expenses paid, there will be no funds available for distribution to unsecured creditors." 

Tort clamants, i.e., the victims and families of victims, are unsecured creditors within the meaning of the Bankruptcy Code.  In essence, PCA's assets, such as they are, are being turned over to its banks, and except to the extent of any insurance that may be available, the victims will have no recovery from PCA. 

PCA Recall - Insurance Lessons for Food Sellers

Bill Marler posted on his blog recently a complaint for declaratory relief filed by an insurer for Peanut Corporation of America (“PCA”). Mr. Marler comments, “Frankly, I read this suit several times and still do not see what the fight is about.” For those who represent commercial insureds in pursuing coverage from their insurers, the suit is no surprise. The suit is likely a function of the fairly limited insurance limits available to PCA, PCA’s tender of both bodily injury and recall expense related claims, possible exclusion for organic pathogens and/or allegations of intentional acts by PCA.

The complaint filed by PCA’s carrier, Hartford Casualty Insurance Company, alleges that PCA had at the time of the outbreak a $1 million primary liability insurance policy and $10 million umbrella insurance policy. Given the high number of probable personal injury claims (some of which will involve wrongful death) and the broad scope of products affected by the recall, claims will far exceed limits available to PCA under the Hartford policies. This outbreak demonstrates why any food manufacturer or seller should carefully consider whether its insurance limits are sufficient. A $10 million policy might have seemed to PCA like a great deal of coverage prior to the outbreak; today, the prevailing perception is that it is totally inadequate.
 

The complaint also alleges that the Hartford policies included “terms, conditions, exclusions, and limitations including but not limited to those pertaining to . . . coverage for claims arising out of the presence, suspected presence, or exposure to, among other things, bacteria.” The policies are not attached to the complaint. However, the allegation suggests that the Hartford policy might have included an organic pathogens exclusion. If the policy includes such an exclusion, PCA may be without coverage for any claims related to the Salmonella outbreak. The organic pathogens exclusion may exclude any claim for bacterial contamination of food products. As we’ve discussed previously on this blog, every food manufacturer should review its coverage to ensure that its policy does not include an organic pathogens exclusion.
 

Finally, the quick filing of a declaratory relief complaint by Hartford illustrates why a food seller needs to engage an experienced insurance coverage counsel immediately. Coverage counsel can assist in developing a strategy to pursue and preserve available insurance. Also, in situations such as PCA’s, all communications with insurers should be managed by coverage counsel. From the outset, communications with insurers are critical because they are likely to become relevant to the inevitable coverage disputes with the carriers.

Irradiation as a Part of Food Safety Reform?

In the wake of the latest Salmonella recall, Congress is holding well-publicized food safety hearings, and food safety may be rising on the priority list of the Obama administration. One question that arises is whether the perceived crisis in food safety will lead lawmakers and the public to revisit the option of food irradiation. The New York Times recently ran a nice piece on the topic. The article begins:  

Before the recent revelation that peanut butter could kill people, even before the spinach scare of three summers ago, the nation’s food industry made a proposal. It asked the government for permission to destroy germs in many processed foods by zapping them with radiation.  

That was about nine years ago, in the twilight of the Clinton administration. The government has taken limited action since.

The article quotes Suresh Pillai, director of the National Center for Electron Beam Research at Texas A&M University, as saying “It’s unnecessary for people to be getting sick today with pathogens in spinach or pathogens in peanut butter.” He describes the potential for irradiation of food as “humongous” and says that “[w]e have the technologies to prevent this kind of illness.” 

As discussed previously on this blog, irradiation has wide support in the food industry and even has the support of plaintiffs’ lawyers such as Bill Marler, who has written a lengthy three-part series on the topic.  

The question may not be whether irradiation is another tool that can prevent food-borne illness, but rather why is irradiation not being used on a wide-scale. Mr. Pillai likened fears of irradiation to “early phobias about the pasteurization of milk.” Aside from lengthy delays in FDA approval, consumer fear may be the problem. The only solutions may lie in (1) a joint effort between industry and lawmakers to educate the public on the benefits and safety of food irradiation, and (2) action by Congress and the FDA to help provide industry with the resources and political cover to begin using irradiation on a wide scale.

FDA's Searchable Widget for Peanut Product Recall

UPDATE to the Salmonella-driven peanut product recall: as the number of peanut products recalled continues to rise, the U.S. Food and Drug Administration has created a Web widget that allows users to search for peanut-containing product recalls (see below).  The FDA updates the list as it receives new information from companies that have recalled products. As discussed in an earlier article, a list of products that are unaffected by the recall is also available.

 FDA Salmonella Typhimurium Outbreak 2009. Flash Player 9 is required.

Avoiding Criminal Prosecution Under The FFDCA

By guest blogger Per Ramfjord

The FDA’s recent announcement that it is pursuing a criminal investigation of Peanut Corporation of America, arising out of the Salmonella-driven peanut product recall, is sure to raise concerns with executives in food product companies throughout the country. White House Press Secretary Robert Gibbs’s comment that the Obama administration intends to put in place a “stricter regulatory structure” to prevent breakdowns in food safety only heightens that concern.

And looking at the law, there are reasons to be concerned. The Federal Food, Drug, and Cosmetic Act criminalizes under sections 331 and 333 more than two dozen practices, including a host of activities associated with the manufacture or sale of contaminated food products. The potential punishment for such offenses includes corporate fines and the possible imprisonment of executives for up to one year for misdemeanor offenses or up to three years for felony violations. The burden of proof to establish such crimes against corporate executives is very low. For misdemeanor offenses, the government needs to prove only that the violation occurred under the executive’s watch; it need not show that the executive had any actual criminal intent or personal involvement in the violation. For felony violations, the government can prove the required intent simply by showing that a defendant consciously avoided knowledge of the violation or was involved in a prior violation.

So, the question arises, what should companies do to avoid prosecution if they become aware of potential criminal violations? The obvious first step is to stop the offending practice as quickly as possible and to identify and take any available remedial action, up to and potentially including a recall. Although there may be concern that the remedial action or recall may itself draw attention to the problem, the benefits of acting in a manner that the government deems responsible will pay off down the road. The second step is to investigate the violation immediately, with counsel, to develop facts that can help steer the case away from criminal enforcement. The FDA will almost always hold a “Section 305” meeting to allow a company to tell its side of the story before initiating a criminal prosecution. The decision about whether to prosecute will be based on factors such as the nature and seriousness of the offense, the potential deterrent effects of prosecution, and the company’s or individual’s culpability, criminal history, and willingness to cooperate. Uncovering evidence to show that the event in question was isolated in nature, due to unique and excusable circumstances, and not part of a pattern of misconduct or noncompliance is critical to making such a meeting a success and to the company’s overall defense going forward. Finally, an important third step is avoiding pitfalls during the investigation itself that could contribute to the government’s decision to prosecute. The current enforcement atmosphere is one in which the “cover-up” is often deemed worse (and more likely to spark prosecution) than the “crime.” Avoiding any false statements, document destruction, or other actions that the government could construe as constituting obstruction of justice is therefore of vital importance.

In sum, obviously the best way to avoid prosecution is to avoid violations, particularly through adopting policies and procedures that minimize risk. But once a potential violation has been discovered, it is vital to respond quickly and with the benefit of counsel who know and understand the system. While any enforcement proceedings are unfortunate, the prospect of criminal proceedings, with their potential of adverse publicity to the company and incarceration of executives, poses unique problems that require a rapid and focused response.

Lengthy List of Products NOT Affected By Peanut Butter Recall

UPDATE  to "Avoiding the Panic" - The American Peanut Butter Council has a website that lists products it knows are UNAFFECTED by the peanut butter recall associated with the current Salmonella outbreak. The list of unaffected products is lengthy and growing. Lets hope the media is successful at assisting consumers avoid the panic by providing them with the information to consume safely the products they enjoy.

Peanut Butter - Avoiding The Panic

Marler Blog and some of the press have been sounding the alarm on all peanut butter products.  True the FDA and CDC have been investigating a multi-state Salmonella outbreak and that there may be a connection with certain peanut butter products. But does this mean that consumers, restaurants and food sellers should avoid all peanut butter products? The answer is NO.

For example. the CDC has stated that:

Preliminary analysis of an epidemiologic study conducted by CDC and public health officials in multiple states comparing foods eaten by ill and well persons has suggested peanut butter as a likely source of the bacteria causing the infections. To date, no association has been found with major national brand name jars of peanut butter sold in grocery stores.

One thing that any restaurant or food seller can do is to educate their customers about the safety of their products. CNN has a great article up today in their Consumer Tips section.  Based on information available to date, the article provides the following guidance for the consumer:

1. Is it safe to make my child a peanut butter sandwich? The FDA says as of Sunday there is no indication that brand name peanut butter sold in grocery stores is linked to the outbreak.

2. What about the peanut butter served at schools? The peanut butter found to contain salmonella bacteria was made by the Peanut Corporation of America. They make peanut butter for institutional use in places like prisons, schools and nursing homes. As a precaution, the Peanut Corporation of America has recalled all peanut butter and peanut paste made in its Blakely, Georgia, plant. That means institutions should no longer be serving it.

3. What about other food made with peanut butter? Officials say for right now, hold off on eating foods that contain peanut butter or peanut paste. Peanut paste is found in commercially made cakes, candies, crackers, cookies and ice cream. The Kellog Co. announced a voluntary recall of 16 products, including Keebler and Famous Amos peanut butter cookies, because they contain peanut butter that could be connected to the Peanut Corporation of America.

 4. How do I know if I have been infected by salmonella? According to the Centers for Disease Control, most people infected by salmonella bacteria develop diarrhea, fever and abdominal cramps 12 to 72 hours after the infection. Most people recover without treatment. However, in some cases salmonellosis, as the infection is called, can be deadly. The infection may spread from the intestines to the blood stream and on to other body parts. Antibiotics need to be administered immediately. The elderly, infants and people with impaired immune systems are more likely to get seriously sick. If you think you may have infected with salmonella, go to the doctor immediately. The doctor can perform lab tests to determine if you have it.

To keep current on the list of products recalled as a result of the recall, sign-up for FDA email alerts and keep in close communication with suppliers.

What to Do When the Investigators Knock . . .

This week brought news of yet another nationwide Salmonella outbreak from a source not yet identified by government regulators. The last time we had a nationwide Salmonella outbreak for an extended period of time without identification of a definitive source the federal government initially singled out tomatoes imported from Mexico (a huge array of products). In that case, the government was wrong and wreaked financial havoc on many farmers and businesses.

So far, in the current outbreak, nothing more specific than “poultry, eggs and cheese” have been identified as possible sources. Last year’s outbreak involved Salmonella Saintpaul whereas the current outbreak is Salmonella Typhimurium, which is more commonly associated with poultry, eggs and cheese, but could come from almost anything.

That a source has yet to be identified to the media doesn’t mean that state and federal officials aren’t zeroing in on possible sources. Restaurant owners, retailers and food manufacturers should be ready for the regulators when they come knocking.

In the past, I’ve had clients who were worked over aggressively by regulators (especially federal officials) who were investigating a large, nationwide outbreak with an uncertain cause. These officials face enormous pressure from those in Washington and from the public. Federal officials can make demands that threaten an entire business. They can demand credit card receipts, contact information for customers, personal employee information, shutdown of the business and more. Noncompliance might mean the officials will go to the press and advertise that the business is a target of the investigation. Unlike local health officials, who are usually vested in the well-being of local food producers under their jurisdiction, federal officials may care only about the investigation and nothing else.

Any food business should implement its crisis response team the minute it suspects it could be targeted in an investigation like the one that is currently ongoing. Specialists in food safety and foodborne illness investigations, genetic microbiologists, public relations experts, accountants, quality assurance personnel, purchasing personnel and lawyers should be lined up and ready to go. Events may unfold quickly for your business (over the course of a day or even a morning). Everything needs to be done at that moment to assist a business in navigating what may appear to be an impossible crisis.
 

Is It Really A Food-Borne Illness?

At a recent presentation, Dr. Alan Melnick, a public health officer in both Oregon and Washington, provided a useful list of alternative causes of symptoms to consider when someone claims a food-borne illness. Other causes of symptoms that might be confused for food-borne illness include (but may not be limited to):

Another practical piece of advice offered by Dr. Melnick: When assessing a food-borne illness claim, determine whether the incubation period is compatible with the illness. Incubation periods (along with other useful information) were provided by Dr. Melnick (relying upon the CDC) as follows:

Pathogen

Incubation

Symptoms

Duration

Source

Bacillus cereus

1-6 hours (vomiting); 6-24 hours (diarrhea)

Nausea and vomiting or colic and diarrhea 24 hours (short form); 24-48 hours (long form) Soil organism found in raw, dry and processed foods, e.d. rice
Campylobacter 2-10 days; usually 2-5 days Diarrhea, cramps, fever and vomiting; diarrhea may be bloody 2-10 days Raw and undercooked poultry, unpasteurized milk, water
Clostridium botulinum (botulism) 2 hours to 8 days; usually 12-48 hours Vomiting, diarrhea, blurred vision, double vision, difficulty swallowing, descending muscle weakness Variable (days to months) Home-canned food, improperly canned commercial foods
Clostridium perfringens 6-24 hours Cramps, diarrhea 24-48 hours Meats, poultry, gravy; foods kept warm
Enterro-hemorrhagic E. coli, including E. coli O157:H7 and other Shiga toxin-producing E. coli (STEC) 1-10 days; usually 3-4 days Diarrhea, frequently bloody; abdominal cramps (often severe); little or no fever; 5-10% develop Hemolytic-uremic syndrome (HUS) and average of 7 days after onset, when diarrhea is improving (more common in children, elderly and immune-compromised) 5-10 days Ground beef, unpasteurized milk and juice, raw fruits and vegetables, contaminated water, sprouts, person to person
Listeria 9-48 hours for GI symptoms; 2-6 weeks for invasive disease Fever, muscle aches and nausea or diarrhea; pregnant women may have flu-like illness and stillbirth; elderly, immune-compromised and infants infected from mother can get sepsis and meningitis Variable Fresh soft cheeses, unpasteurized or inadequately pasteurized milk, ready-to eat deli meats and hot dogs
Salmonella 6 hours to 10 days; usually 5-48 hours Nausea, diarrhea, cramps, fever 4-7 days Poultry, eggs, meat, unpasteurized milk or juice, raw fruits and vegetables (e.g., sprouts), person to person
Shigella 12 hours to 6 days; usually 2-4 days Abdominal cramps, fever and diarrhea; stool may contain blood and mucus 4-7 days Contaminated food or water, raw foods touched by food workers, raw vegetables, egg salads, person to person
Staph (toxin) 30 minutes to 8 hours; usually 2-4 hours Nausea, cramps, vomiting, diarrhea  24-48 hours Custards, cream fillings, potato or egg salad, sliced meats
Vibrio cholerae 1-5 days Profuse watery diarrhea and vomiting, severe dehydration 3-7 days Contaminated water and shellfish, street vended food 
Vibrio parahaemolyticus 4-30 hours Watery diarrhea, abdominal cramps, nausea, vomiting  2-5 days Undercooked or raw seafood (fish and shellfish) 
Vibrio vulnificus 1-7 days Vomiting, diarrhea, abdominal pain; more severe in patients with liver disease or who are immune-compromised; can cause invasive infection (sepsis) 2-8 days Raw seafood, particularly oysters, harvested from warm coastal waters 
Yersinia 1-10 days; usually 4-6 days Appendicitis-like symptoms (diarrhea and vomiting, abdominal pain)  1-3 weeks  Undercooked pork, unpasteurized milk, contaminated water

 

2009 Priorities for USDA in Food Safety

I just returned from ACI’s Second National Forum on Food-Borne Illness, which included several interesting presentations and discussions. One was by Dan Engeljohn, Deputy Assistant Administrator of the Office of Policy and Program Development at the Food Safety and Inspection Service (“FSIS”). Mr. Engeljohn spoke about FSIS’s priorities for “2009 and beyond.” Takeaways from this presentation include:

Non-O157 STECs

FSIS is increasingly concerned with strains of E. coli other than O157:H7. Non-O157:H7 strains such as E.coli O121:H19 and O111 are growing more prevalent in the environment. FSIS is putting additional resources into developing methodology for detection of non-O157 STECs.

As FSIS, CDC, FDA and local health departments develop this methodology, the industry can expect more reported outbreaks and more liability exposure. Most experts believe that many non- O157:H7 outbreaks go undetected. Increased focus on detection of non-O157 E. coli strains is yet another reason to examine the sufficiency of your companies' insurance limits.

Frozen, Not Ready to Eat Meals


According to Mr. Engeljohn, because of recent salmonella scares, FSIS remains concerned about “frozen, not ready to eat” meals and specifically “frozen, not ready to eat” poultry meals. He explained that “evidence is mounting that these products cannot be safely prepared unless salmonella is controlled in the source materials.” In other words, FSIS now believes that no amount of package labeling or consumer education can prevent consumers from undercooking these meals.

FSIS jurisdiction over salmonella in poultry is limited. FSIS attempts restrict the sale of “frozen, not ready to eat” meals or impose more stringent standards against salmonella in poultry may be a reach for the agency. As discussed in Supreme Beef Processors v. USDA Salmonella, "is not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat 'inspected and passed.'" Absent statutory reform, FSIS action in this area may be challenged.

Listeria


Mr. Engeljohn stated that FSIS is “deeply concerned” about listeria. It believes that gains made in recent years at meatpacking plants may be undone by problems at supermarket deli counters. FSIS believes that little is being done to address critical control points at the retail level, such as proper cleaning and sanitizing of meat slicers. FSIS may be exploring ways to exercise more jurisdiction to regulate supermarket delis.

Yes, We Have No Tomatoes

By Guest Blogger Richard Goldfarb
Sunday, at a local restaurant, I saw a sign saying that there would be no fresh sliced tomatoes on my burger. Although it is quite clear that there are safe tomatoes available, the FDA has encouraged restaurants simply to cease selling them. This makes a lot of sense: rumors fly so rapidly and irresponsibly. Though, individual restaurants may take different steps; those that pride themselves on knowing the source of their heirloom tomatoes should be advertising that fact.

The problem is salmonella, in particular a strain called “saintpaul.” The FDA identified salmonella in tomatoes as a significant risk a year ago.  Thus, they had the infrastructure in place to monitor and deal with the significant number of reported outbreaks this year. So far, no one knows the source of the problem, and all the FDA can do at this point is to list those tomatoes that have not been associated with the outbreaks:

• Cherry tomatoes
• Grape tomatoes
• Tomatoes sold with the stems on
• Homegrown tomatoes

In addition, the FDA lists those tomato-growing areas that have been ruled out in the outbreaks. This doesn’t mean that tomatoes grown in those areas will always be safe, but that they have not been linked to this outbreak. The FDA also reiterates its advice on the safe handling of fresh tomatoes and other fresh fruits, both in restaurants and at home. The CDC website provided a nice summary:

• Refrigerate within 2 hours or discard cut, peeled, or cooked tomatoes.
• Avoid purchasing bruised or damaged tomatoes and discard any that appear spoiled.
• Thoroughly wash all tomatoes under running water.
• Keep tomatoes that will be consumed raw separate from raw meats, raw seafood, and raw produce items.
• Wash cutting boards, dishes, utensils, and counter tops with hot water and soap when switching between types of food products.

The problem isn’t limited to the United States; New Zealand tomatoes have been implicated as well, and banned in Hong Kong.  It was nice to know that the tomatoes we had with dinner last night were doubly safe: they were hothouse tomatoes sold with the stems on, and they were from British Columbia, one of the locales ruled out by the FDA.