Some Take-Aways from ACI's 3rd National Forum on Food-Borne Illness Litigation
American Conference Institute (ACI) recently held its latest conference on food-borne illness litigation. The conference has been a fairly intimate gathering of the nation’s lawyers, insurers and experts involved with food-borne illness litigation.
This year, I had the privilege of moderating an in-house counsel “think tank.” The panel was composed of lawyers from a nice cross-section of food businesses: Yum Brands, Hormel, Fresh Express and SUPERVALU (though for each, food-borne illness litigation is a rare event) A slide-deck from the panel can be found here.
Also among the presenters at this year’s conference were Center for Disease Control’s (CDC) Dr. Arthur Liang and USDA/FSIS representative Dr. Dan Engeljohn. Both presentations provided fascinating insight into changes afoot in food safety enforcement and policy at the federal level. Here are some of the take-aways:
• “Outbreaks Waiting to Be Discovered” – Dr. Liang opined that, based on surveilled illnesses, most food-borne illness outbreaks are not presently discovered. He believes that recent data shows that there are perhaps 2-3 times more outbreaks nationally than what’s been uncovered over the last few years.
• Food Safety Progress Being Undone by Retail Deli Operations – FSIS says there has been a “steady increase in risky behavior at the retail level.” According to Dr. Engeljohn, budget authority is being sought to intervene with retailers, particularly smaller supermarket deli operations.
• Negative Tested Product Can Be Considered Adulterated - FSIS will be issuing a policy soon that for the first time will consider a “negative tested product to be determined adulterated” under circumstances where an associated product tested positive for pathogens.
• Non-0157 STECs - FSIS will be finalizing methodology to detect non-0157 Shiga Toxin-Producing Escherichia coli (STEC).
2010 Food Safety Education Conference Announced
The U.S. Department of Agriculture’s Food Safety and Inspection Service has announced the 2010 Food Safety Education Conference. The conference will be held in Atlanta from March 23 through 26, 2010. Although the agenda is still a work in progress, you can expect sessions on foodborne illnesses, outreach to the medical community, food safety education initiatives, social marketing, and emerging industry trends and technologies.
The conference is accepting abstracts on food safety-related topics through August 16, 2009. More information on the conference and the abstract submission process is available through the links on the widget below.
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.
Michigan Company Announces Frozen Pasta Recall
A Michigan maker of frozen pasta products has issued a recall for products that were distributed to seven states. Canton, Mich.-based Mucci Food Products is recalling an undetermined amount of frozen meat and poultry pasta products because the food was prepared without federal inspection.
The products were produced from May 1, 2008 to April 24, 2009 and distributed to California, Florida, Georgia, Illinois, Michigan, Missouri, and Ohio. The recalled products bear the establishment number “19177” or “P-19177” inside the USDA mark of inspection and the dates “1218” to “1149” located at the bottom of the product box.
The U.S. Department of Agriculture’s Food Safety and Inspection Service has complete details of the products subject to the recall, including images of the product labels. The USDA has not received any reports of illness as a result of consumption of the products.
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:
- Campylobacter
- Cryptosporidium
- Cyclospora
- Listeria
- Shiga toxin-producing Escherichia coli (STEC) O157
- Salmonella
- Shigella
- Vibrio
- Yersinia
- STEC non-O157
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.
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.
