The Park Doctrine and Jensen Farms

Many were surprised by the recent arrest of the Jensen Farm’s owners for selling Listeria contaminated cantaloupes that caused 33 deaths (http://pennstatefoodsafety.blogspot.com/2013/09/jenson-brothers-growers-of-tainted.html). Introducing the Park Doctrine. All responsible company officials, whether their company is manufacturing food items OR distributing food items manufactured by someone else, should be aware of the implications. 

 From the FDA Law Blog – Feb 2, 2011 (reference below):

“… a corporate official can be convicted of a misdemeanor based solely on his position of responsibility and control to prevent the underlying violation of the FDCA. There is no requirement that the official acted personally in the wrongdoing, or that he even had knowledge of it. The Supreme Court determined that the FDCA “imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur.” Park, 421 U.S. at 672.”

 This is not limited to the processors, but to those who utilize contract manufacturers. From the FDA Law Blog – May 28, 2013 (reference below):

“The letters cite Park and Dotterweich to support the legal theory that a distributor that uses contract manufacturers or labelers may be liable (or convictable) for Current Good Manufacturing Practice ("CGMP") violations by its contractors.”

This is different than the PCA Peanut Butter cases, where officials knew they were shipping contaminated product. As seen in the Jensen case, it is more of a point that they should have known and taken preventive actions.


FDA Law Blog

February 06, 2011

FDA Finally Releases “Non-binding” Park Doctrine Criteria

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/02/fda-finally-releases-non-binding-park-doctrine-criteria.html

By Anne K. Walsh –

Eleven months after telling Senator Grassley (in a letter available here) that “[c]riteria now have been developed for consideration in selection of misdemeanor prosecution cases and will be incorporated into the revised policies and procedures that cover appropriate use of misdemeanor prosecutions,” FDA just last week finally released those criteria. The idea behind such criteria is to increase misdemeanor prosecutions against corporate officials under the Park doctrine. 

Jenson Brothers, Growers of Tainted Canteloupes, Arrested

The Jensen brothers, owners of the farm that grew and packed the Listeria tainted cantaloupes which were responsible for killing 33, have been arrested and now face jail time for the incident. This is in addition to having their farm go bankrupt, one owned by the family for generations. 

This case is a huge deal for all food operations in that owners/managers are facing prison for a foodborne outbreak. While all basically agree that there was no intent by the Jensen brothers, it is the fact that the shipped contaminated product from an operation with food safety lapses that have led to the misdemeanor charges, where intent is not a factor. The food safety lapses can be summed up”

1) They installed a potato washer to wash cantaloupes. It did not wash cantaloupes well, it did not cool them, and the equipment was not easy to clean. Because it was not easy to clean, it actually served as a source of contamination. By not cooling, the warmer temperatures provided better growing conditions for Listeria on the outside of the cantaloupe.

2) The chlorine sanitizer spray system was not operational.

The later point is worth noting. In certain applications, it is easy to overlook these microbial reduction interventions. Who knows, perhaps the location of the spray nozzles were located at a point where the chlorine would be quickly inactivated because of the solids on the cantaloupes, so they decided not to hook them up. 

It can be easy to look at a number of bacterial reduction interventions and wonder if there is a significant impact versus the cost of operating that intervention, or operating it at the level it should be operated. Or even maintaining the appropriate verification steps (checking concentration, conducing bacterial counts before and after) to ensure that the intervention is operating at that level it is supposed to be operating. 

So when the unfortunate event occurs, in this case one of the most deadly foodborne outbreaks in US history, investigators are going to look at everything - Is the process right for the products it is processing? Are the appropriate antimicrobial systems in place that are standard in the industry? Are the antimicrobials systems that are in place working, and are they operating at the right parameters? 

Companies need to use this case as a reason to review all processes, with specific attention to these antimicrobial interventions. If a system is in place, make sure it is working as it designed. If these systems are not operating, then either fix it. If they have been abandoned, then move it, replace it or remove it.

Note that these brothers are just farmers, one 37 years old, and the other 33. While the thought of jail time probably pales in comparison to the responsibility for 33 deaths, they probably wonder how some poor decisions led to where they are now.


United States Attorney’s Office – District of Colorado
New Release
http://www.justice.gov/usao/co/index.html

Eric and Ryan Jensen charged with introducing tainted cantaloupe into interstate commerceFOR IMMEDIATE RELEASE

September 26, 2013

DENVER – Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, located in Granada, Colorado, presented themselves to U.S. Marshals in Denver today, where taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation, United States Attorney John Walsh and Food and Drug Administration (FDA) Office of Criminal Investigations Special Agent in Charge Patrick Holland announced. The Information charges the brothers with introducing adulterated food into interstate commerce. The defendants are scheduled to make their initial appearance this afternoon at 2:00 p.m. before U.S. Magistrate Judge Michael E. Hegarty. At that hearing they will be advised of their rights as well as the charges pending against them.

According to the six-count Information filed under restriction on September 24, 2013, as well as other court records, Eric and Ryan Jensen allegedly introduced adulterated cantaloupe into interstate commerce. Specifically, the cantaloupe bore a poisonous bacteria, Listeria monocytogenes. The Information further states that the cantaloupe was prepared, packed and held under conditions which rendered it injurious to health.

Salad Items Recalled due to Potenial Listeria Contamination

Update 10/25/13 - Garden Fresh is expanding its recall http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2013/recall-055-2013-expansion

Garden Fresh Foods of Wisconsin is recalling various salad, slaw and dip items due to the potential for Listeria monocytogenes. The problem was discovered through product testing conducted by FDA.  To date, there have not been any reported illnesses.

Product was shipped nationally under various brand names: Market Pantry, Archer Farms (both Target brands), D’Amico and Sons, Finest Traditions, Garden Fresh and Weis.

This same company issued a recall back at the beginning of the month. This was a smaller recall, that for potato salad, but for the same reason – the potential for Listeria as well (link below). That was discovered through routine sampling. Being that occurred over three weeks ago, it would probably indicate the company was under increased scrutiny. And this may be why the latest recall notice indicated that the pathogen was discovered through testing done by FDA.

As we discuss many times, this is a reason for companies using co-packing operations to watch recall notices and consider strong action when their co-packer has an issue. It may not be your brand initially impacted or even the product you purchase, but in too many cases, we see these contamination events rapidly expand when FDA or USDA investigate smaller issues and find the troubled manufacturer has bigger issues that impact a broader set of products.


USDA Recall Alert
Wisconsin Firm Recalls Ready-To-Eat Chicken And Ham Products Due To Potential Listeria Monocytogenes Contamination
Class I Recall 055-2013

Health Risk: High Sep 25, 2013

Congressional and Public Affairs
Catherine Cochran
(202) 720-9113

WASHINGTON, Sept. 25, 2013 – Garden Fresh Foods, a Milwaukee, Wisc.establishment, is recalling approximately 19,054 pounds of ready-to-eat chicken and ham products due to possible contamination with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Overstating the Link of Antibiotic Resitant Bacteria in Animals to Humans

There has been a huge concern on the importance of antibiotic resistant strains of Salmonella in domestic animals and their impact on humans.  In a comprehensive study conducted over a 22 year period that evaluated DNA variation, researchers have found that there is little cross-over from animals to humans and therefore domestic animals are unlikely to be a major source of antibiotic resistant Salmonella strains in humans.

“The team discovered that, contrary to much current thinking, the populations of Salmonella in humans and animals were distinguishable. They also found that the estimated number of times that the bacteria had jumped from animals to humans (and vice versa) was remarkably low. In addition, there was greater diversity in antibiotic resistance genes in salmonellae isolated from humans. Taken together, these findings suggest that the contribution of local animal populations to human infections with S. Typhimurium DT104 may previously have been overstated.”

The author of the study goes on to say “"This finding in no way undermines the importance of prudent antimicrobial use in all species. But our study does demonstrate that greater effort needs to be focused on understanding the natural history of the pathogens and on identifying the major sources of resistance in our global ecosystems."

With regard to our inability to completely comprehend why and where bacteria do what they do, Dr. Steve Goodfellow, a seasoned food microbiologist, liked to say that ‘bacteria don’t read the textbooks’.   I think we can also say that bacteria don’t follow stories put out by the news media either.

 

Contribution of Local Animal Populations to Human Salmonella Infections Overstated

Science Daily
http://www.sciencedaily.com/releases/2013/09/130912143421.htm

Sep. 12, 2013 — A new study has shown that, contrary to popular belief, local domestic animals are unlikely to be the major source of antibiotic resistant Salmonella in humans. The result comes from a detailed study of DNA from more than 370 Salmonella samples collected over a 22-year period.

By studying the genetic variation in the Salmonella bacteria and their drug resistance genes, researchers found that distinguishable bacterial populations exist in human and animal populations living side by side. Antibiotic resistance is considered to be one of the most important dangers to human health, threatening to make many treatments to common infections ineffective. By comparing the genomes of Salmonella in humans and animals the researchers have provided important new insights into the likely sources and spread of antibiotic resistant infections. First, the Salmonella bacteria largely remained within their original host populations and second, there were more varied combinations of drug resistance in the human-infecting bacteria.

Salmonella infection is a global issue, with approximately 94 million people contracting gastroenteritis or food poisoning each year. The combined annual cost in the United States and European Union is estimated to be more than £4 billion ($6 billion). This public health issue is exacerbated further by antibiotic resistance, which can lead to more complicated and protracted illness in patients and increased treatment costs.

"For the first time we've determined in detail and on a large scale how Salmonella strains taken from humans and animals in the same setting and over the same time period relate to each other," says Dr Alison Mather, first author on the study, from the Wellcome Trust Sanger Institute. "Our genomic data reveal how the Salmonella bacteria spread during the course of a long-term epidemic. We found that people have a more diverse source of infection and antibiotic resistance than just the local animals, pointing towards alternative sources."

The team sequenced DNA from 373 samples from humans and animals infected with Salmonella Typhimurium DT104 over a 22-year period, mainly from Scotland, but also from other countries. This is the largest study of its type; whole genome DNA sequencing delivers the highest level of resolution possible to examine how closely related the bacteria are, enabling the team to unravel the details of this epidemic.

The team discovered that, contrary to much current thinking, the populations of Salmonella in humans and animals were distinguishable. They also found that the estimated number of times that the bacteria had jumped from animals to humans (and vice versa) was remarkably low. In addition, there was greater diversity in antibiotic resistance genes in salmonellae isolated from humans. Taken together, these findings suggest that the contribution of local animal populations to human infections with S. Typhimurium DT104 may previously have been overstated.

Chobani Recalls Greek Yogurt Due to Quality Issues

Chobani is recalling its Greek Yogurt due to issues encountered by consumers, namely product bloating / swelling. News reports suggest the issue may be related to mold and that there may be some related illnesses.

Initially the company cited this as a quality issue and did not recall the product. But after public outcry and a solid media beat-down, the company issued a recall and ceased distribution of the product (Guardian article below).

Chobani pioneered Greek yogurt, and now controls 35% of the Greek yogurt market. And this market has taken a serious bite out of the traditional yogurt markets, now accounting for about 1/3 of the US yogurt market. Much of this is due to the products higher protein content compared to traditional yogurt (see the nice NY Times article below).

This issue and the lack of a firm response will certainly give the competitors a leg up. Especially when this company had such a ‘consumer oriented’ brand. We’ll need to watch how market share changes after this incident. This case is one of those hard lessons all food companies can learn from.


FDA News Release
Chobani, Inc. Voluntarily Recalls Greek Yogurt Because of Product Concerns
FOR IMMEDIATE RELEASE - September 5, 2013 - Chobani, Inc., of Twin Falls, Idaho is voluntarily recalling Greek Yogurt.
http://www.fda.gov/Safety/Recalls/ucm367298.htm

The company has ceased the distribution of the product due to reports of product bloating and swelling and some claims of illness as the company continues its investigation to identify the root cause.