Food Safety News and yours truly received a nice “Shout-out” from Mark Bittman of the New York Times today as to things he is thankful for:
But kudos aside, I am acutely aware of the pain and suffering that gives me the chance to be “the leading food safety attorney,” and that gives Food Safety News stories to tell. Here are just three outbreaks that share more than just me as a common feature:
1. Peanut Corporation of America Salmonella Outbreak: As of April 20, 2009, 714 persons infected with the outbreak strain of Salmonella Typhimurium were reported from 46 states. The number of ill persons identified in each state is as follows: Alabama (2), Arizona (14), Arkansas (6), California (81), Colorado (18), Connecticut (11), Florida (1), Georgia (6), Hawaii (6), Idaho (17), Illinois (12), Indiana (11), Iowa (3), Kansas (2), Kentucky (3), Louisiana (1), Maine (5), Maryland (11), Massachusetts (49), Michigan (38), Minnesota (44), Missouri (15), Mississippi (7), Montana (2), Nebraska (1), New Hampshire (14), New Jersey (24), New York (34), Nevada (7), North Carolina (6), North Dakota (17), Ohio (102), Oklahoma (4), Oregon (15), Pennsylvania (19), Rhode Island (5), South Dakota (4), Tennessee (14), Texas (10), Utah (8), Vermont (4), Virginia (24), Washington (25), West Virginia (2), Wisconsin (5), and Wyoming (2). Additionally, one ill person was reported from Canada. Among the persons with confirmed, reported dates available, illnesses began between September 1, 2008 and March 31, 2009. Patients range in age from <1 to 98 years. The median age of patients is 16 years which means that half of ill persons are younger than 16 years. 21% are age <5 years, 17% are >59 years. 48% of patients are female. Among persons with available information, 24% reported being hospitalized. Infection may have contributed to nine deaths: Idaho (1), Minnesota (3), North Carolina (1), Ohio (2), and Virginia (2).
The first and only FDA inspection report found a facility out of control with little if any concern for food safety. The FDA also found that PCA sent out peanut butter, chopped peanuts and peanut meal that had tested positive even before it got back any negative findings. Also, in some instances PCA shipped product before it received tests back and then did not recall.
2. Wright County Egg and Jack DeCoster Salmonella Outbreak: In July 2010, CDC identified a nationwide sustained increase in the number of Salmonella Enteritidis isolates with PFGE pattern JEGX01.0004 uploaded to PulseNet, the national subtyping network made up of state and local public health laboratories and federal food regulatory laboratories that performs molecular surveillance of foodborne infections. An increase in reports beginning in May, peaking in July, and returning to baseline in November, is evident in the epidemic curve, or epi curve. From May 1 to November 30, 2010, a total of 3,578 illnesses were reported. However, some cases from this period may not have been reported yet, and some of these cases may not be related to this outbreak. Based on the previous 5 years of reports to PulseNet, we would expect approximately 1,639 total illnesses to occur during this same period. This means there are approximately 1,939 reported illnesses that are likely to be associated with this outbreak. Because of the large number of expected cases during this period, standard methods of molecular subtyping alone are not sufficient to determine which reported cases might be outbreak-associated.
The first and only FDA inspection report found:
• Chicken manure located in the manure pits below the egg laying operations was observed to be approximately 4 feet high to 8 feet high at the following locations: Layer 1 – House 1; Layer 3 – Houses 2, 7, 17, and 18. The outside access doors to the manure pits at these locations had been pushed out by the weight of the manure, leaving open access to wildlife or domesticated animals.
• Un-baited, unsealed holes appearing to be rodent burrows located along the second floor baseboards were observed inside Layer 1 – Houses 1-9 and 11-13; Layer 2 – Houses 7 and 11; Layer 3 – Houses 1, 3, 4, 5, and 6; Layer 4 – House 3.
• Dark liquid which appeared to be manure was observed seeping through the concrete foundation to the outside of the laying houses at the following locations: Layer 1 – Houses 1, 2, 3, 4, 5, 8, 11, 12, and 14; and Layer 3 – Houses 1, 8, 13, and 17.
• Standing water approximately 3 inches deep was observed at the southeast corner of the manure pit located inside Layer 1 – House 13.
• Un-caged birds (chickens having escaped) were observed in the egg laying operations in contact with the egg laying birds at Layer 3 – Houses 9 and 16. The un-caged birds were using the manure, which was approximately 8 feet high, to access the egg laying area.
• Layer 3 – House 11, the house entrance door to access both House 11 and 12 was blocked with excessive amounts of manure in the manure pits.
• There were between 2 to 5 live mice observed inside the egg laying Houses 1, 2, 3, 5, 7, 9, 10, 11, and 14.
• Live and dead flies too numerous to count were observed at the following locations inside the egg laying houses: Layer 1 – Houses 3, 4, 6, 8, 9, 11, and 12; Layer 2 – Houses 7 and 11; Layer 3 – Houses 3, 4, 4, 5, 7, 8, 15, 16, 17, and 18. The live flies were on and around egg belts, feed, shell eggs and walkways in the different sections of each egg laying area. In addition, live and dead maggots too numerous to count were observed on the manure pit floor located in Layer 2 – House 7.
3. Jensen Farms and Frontera Listeria Outbreak: As of November 1, 2011, a total of 139 persons infected with any of the four outbreak-associated strains of Listeria monocytogenes have been reported to CDC from 28 states. The number of infected persons identified in each state is as follows: Alabama (1), Arkansas (1), California (2), Colorado (39), Idaho (2), Illinois (3), Indiana (3), Iowa (1), Kansas (10), Louisiana (2), Maryland (1), Missouri (6), Montana (1), Nebraska (6), Nevada (1), New Mexico (15), New York (2), North Dakota (2), Oklahoma (11), Oregon (1), Pennsylvania (1), South Dakota (1), Texas (18), Utah (1), Virginia (1), West Virginia (1), Wisconsin (2), and Wyoming (4). Nevada and Utah have reported their first case each since the last CDC update. Among persons for whom information is available, reported illness onset ranges from July 31, 2011 through October 21, 2011. Ages range from <1 to 96 years, with a median age of 77 years. Most ill persons are over 60 years old. Fifty-seven percent of ill persons are female. Among the 134 ill persons with available information on whether they were hospitalized, 132 (99%) were hospitalized. State and local health departments in these and other states are investigating other listeriosis illnesses to determine if they are part of this outbreak. Twenty-nine deaths have been reported: Colorado (8), Indiana (1), Kansas (3), Louisiana (2), Maryland (1), Missouri (2), Nebraska (1), New Mexico (5), New York (2), Oklahoma (1), Texas (2), and Wyoming (1). Among persons who died, ages range from 48 to 96 years, with a median age of 81 years. In addition, one woman pregnant at the time of illness had a miscarriage.
Five of the illnesses were related to a pregnancy; two were diagnosed in newborns and three were diagnosed in pregnant women. One miscarriage has been reported. Other outcomes are being monitored.
The FDA’s first and only inspection found:
Introduction of Listeria:
• There could have been low level sporadic Listeria monocytogenes in the field where the cantaloupe were grown, which could have been introduced into the packing facility
• A truck used to haul culled cantaloupe to a cattle operation was parked adjacent to the packing facility and could have introduced contamination into the facility
Spread of Listeria:
• The packing facility’s design allowed water to pool on the floor near equipment and employee walkways
• The packing facility floor was constructed in a manner that made it difficult to clean
• The packing equipment was not easily cleaned and sanitized washing and drying equipment used for cantaloupe packing was previously used for postharvest handling of another raw agricultural commodity
Growth of Listeria:
• There was no pre-cooling step to remove field heat from the cantaloupes before cold storage. As the cantaloupes cooled there may have been condensation that promoted the growth of Listeria monocytogenes.
The civil litigation side of the PCA and Wright County Outbreaks have ended or nearly so. Both companies have ceased to exist. Monetary compensation has been paid. For those who did not die or suffer permanent injury, most have recovered – although may look at peanut butter and eggs differently. The Jensen Farms and Frontera Outbreak will too take its course – with bankruptcy in the picture as well as involvement in the litigation by auditors and retailers.
So, other than me, what is the common denominator? Three criminal investigations.
Yes, I have repeatedly argued for greater involvement by criminal (felony and misdemeanor) prosecutors. And, although slower that the victims or me (and families) might like, there still seems to be life in the PCA investigation and it appears that things are happening in both the Wright County and Jensen Farms investigations as well.
Civil litigation does much, but more needs to be done to give victims a far greater sense of accountability. I wish the prosecutors well. Provisions for criminal sanctions are clear:
Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by not more than three years or fined not more than $10,000 or both.
A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $1,000, or both.