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  Dear friends, Season’s greetings!  We would like to express our sincere gratitude for all of you who have joined us.  Happy Holidays and may 2017 be a safe and prosperous year. Wishing you success and happiness in 2017   happy-new-year-2017

Crowdsourcing and Food Safety




Crowdsourcing is defined as taking a job that is traditionally performed in an organization by employees and outsourcing it to a crowd of undefined network of people (non-employees) in the form of an open call. The crowdsourcing participants can be from anywhere, with all backgrounds, as long as they have Internet connection. The use of crowdsourcing is increasing rapidly and had been used in idea generation, wikies, open source software citizen reporters or journalism, citizen science, disaster management.
Crowdsourcing utilization in food projects has increased rapidly where companies have for example encouraged consumers to vote for new flavors, colors, names, better design, etc. More recently crowdsourcing was extended to crowdfunding and numerous startups were able to raise sufficient funds to jumpstart their operations. However, the utilization of crowdsourcing in food quality and safety is missing. (Definition supplied by Prof. (Emer.) Sam Saguy (
Crowd sourcing can also be defined as “obtain information or input into a particular task or project by enlisting the services of a number of people, either paid or unpaid, typically via the Internet.”  The use of crowdsourcing is increasing rapidly are you using it?
crowrdsourcing-f1 The BioExpert site is an example of crowdsourcing in the food safety arena. The participant (crowd) is selected from food safety professionals.
I received the following request from Dr. Jan Mei Soon – and Prof. (Emer.) Sam Saguy –
Re: Crowdsourcing Questionnaire Food Quality and Safety
Dear Colleague,
We (Jan Mei Soon – and Sam Saguy – are preparing a paper on the possible utilization of Crowdsourcing* (see below) focusing on specific possible applications of this unique recent evolving approach for food quality and safety. We hereby would welcome and be most appreciating if you could share with us from your own experience and knowledge how this fascinating emerging tool is or will be used and kindly fulfil the questionnaire below. Also ideas are also most welcome. Even if you are not using this technology to day, it would be most helpful if you can share with us your vision on how and/or where it could be applied. If you would like to share with us your name and e-mail we would most definitely communicate with you to express our appreciation and also to elaborate on some of the points you furnished. Thanking you in advance Dr. Jan Mei Soon and Prof. (Emer.) Sam Saguy
The questionnaire below is very simple; please take a minute to reply, and send the answers directly to Dr. Jan Mei Soon – and Prof. (Emer.) Sam Saguy –  

Crowdsourcing Questionnaire Food Quality and Safety

  1. Do you crowdsource (see definition above) for food safety or quality ideas and solutions?
If not:
  • Can you briefly explain why not?
  • Can you envision where and how it could be applied for food quality and/or safety
  • Do you have estimation on the time and/or tools required for implementation?
If yes:
  • What type of crowdsourcing practices do you use?
  • Why do you use crowdsourcing?
  • Are there any specific benefits?
  • Are there any specific drawbacks?
  • Can you describe specific example (s)?
  • Can you estimate the typical time or the duration?
  1. Any additional points to share?
  We would love to get your opinion, comments on this novel concept and its utilization in food safety.

FDA Erroneous Warning Costs Tomato Growers $15 Millions – Court Rules: FDA is Not Liable

tomato1 On December 2, the 4th U.S. Circuit Court of Appeals ruled that the FDA could not be held financially liable for issuing the false warning.  It is clear now that the FDA warning did not help customers who stopped buying perfectly healthy tomatoes, and continued to buy the contaminated hot peppers. This decision was devastating to the tomato growers. The demand for tomatoes plummeted by 40% due to the warnings, and prices fell by 50%. The tomato industry lost millions of dollars.

Case History

As part of the ruling judge Wilkinson described the detailed history of the case: “On May 22, 2008, the New Mexico Department of Health notified the Centers for Disease Control and Prevention that a number of local residents had been infected with Salmonella Saintpaul. Similar reports soon arrived at CDC from Texas.   After interviewing patients, the CDC discovered a “strong statistical association” between the infections and eating raw tomatoes. This observation was supported by a “historical association” between salmonella and tomatoes. The CDC subsequently notified the FDA that tomatoes were the “leading hypothesis” for the source of the outbreak.   On June 7 2008, FDA issued an updated contamination warning titled, “FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes.”  At the time, Salmonella Saintpaul was linked to 1,220 infections across forty-two states and the District of Columbia, as Seaside Farm and other growers were harvesting a large crop of tomatoes.   Over the next month the CDC accumulated enough data to link Salmonella Saintpaul to jalapeño and serrano peppers imported from Mexico. Consequently the FDA withdrew the contamination warning  and announced that fresh tomatoes were no longer associated with the outbreak.   Seaside harvested a crop of tomatoes in South Carolina while the Salmonella Saintpaul contamination warning was in effect. By the time the agency admitted its error on July 17, the case had been amplified into the largest foodborne outbreak in the United States in more than a decade. The FDA incorrect warning costed producer millions and turned good tomatoes into waste.   On May 18 2011, Seaside brought suit against the United States under the FTCA (Federal Tort Claims Act) alleging that the FDA negligently issued the contamination warning and impaired the value of Seaside’s crop by $15,036,293.95. The FDA was accused that they had no confirmation of a link between the outbreak of Salmonella and their tomatoes, and that the analysis done was flawed.   On December 15 2015, the district court dismissed the case for lack of subject matter jurisdiction. The district court reasoned that the FDA had broad discretion to warn the public about a contaminated food supply, and that Seaside failed to allege any statute, regulation, or policy that required the FDA to proceed in a particular manner. The district court also acknowledged that contamination warnings were due to competing policy considerations of protecting the public from serious health risks and minimizing any adverse economic impact on associated industries.

The Ruling

The 4th Circuit agreed with the trial court that the FDA was acting within its authority to issue emergency food safety warnings based on preliminary information in order to protect public health. Turning down the $15 million claim from Seaside Farm, South Carolina   “We refuse to place FDA between a rock and a hard place,” wrote Judge Wilkinson for the panel, sitting in Richmond. “One the one hand, if FDA issued a contamination warning that was even arguably over broad, premature, or of anything less than perfect accuracy, injured companies would plague the agency with lawsuits,” the judge said. “On the other hand, delay in issuing a contamination warning would lead to massive tort liability with respect to consumers who suffer serious or even fatal consequences that a timely warning might have averted,” Wilkinson said.

Questions to be asked

When government agencies like the FDA send an erroneous warning, as clearly happen in this case, and the action caused losses of millions of dollars to the growers, should there be a remedy against the agency? Should anyone be accountable for such losses? Should there be a compensation mechanism?   If there is a remedy against the agency, will it prevent the agency from issuing warnings before all facts are known, and endanger the public?

Environmental Monitoring and FSMA


Why Monitor the Environment?

environmental-monitoringThe requirement for environmental monitoring is mentioned under CFR 21 section 117.165 “Current Good Manufacturing Practice, hazard analysis, and risk based preventative controls for human foods”.   It requires a facility to conduct validation and verification activities, as appropriate to the nature of the preventive controls, to ensure a clean facility.
The validation efforts are based upon a safety plan that is related to hazard analysis. However, because of differences between facilities, the FDA does not define specific factors associated with developing an environmental monitoring program. Instead it is stated that they are required to “be adequate for their intended purpose.”
Environmental monitoring can include monitoring of indicator organisms such as aerobic plate count (APC) but can also include testing of food pathogens such as Listeria or Salmonella. In facilities that are producing ready-to-eat (RTE) items, their environmental monitoring program will be much different from one that involves foods that will be cooked or further processed before being consumed.
For RTEs it is critical that environmental pathogens are controlled to ensure that they do not contaminate the product. For these types of products, perhaps the greatest use of testing lies in environmental pathogen monitoring.
A non-pathogenic indicator organism may be used as a surrogate for a pathogen only if there is scientific evidence to support a direct relationship between the detection of the surrogate and the presence of a specific pathogen.  To date, the only proven predictive surrogate is Listeria innocua or Listeria spp. which is taken as a direct indicator of the presence of L. monocytogenes.
Environmental testing typically entails taking microbiological samples of food contact surfaces or nearby areas, testing for the presence of a pathogen or indicator organism. For dry foods where a raw product or ingredient could be introduced, Salmonella is generally the organism of concern. For RTE foods processed under wet conditions or environments, the organism of concern is generally Listeria monocytogenes.

Role of ATP Monitoring:

One of the most common tests for cleanliness is that of Adenosine triphosphate (ATP). Its detection after the manufacturing equipment has been cleaned, is an indicator that food debris, bacteria or other organisms have been left behind and the cleaning process was not completed.  ATP can be an indicator of the amount of cellular-based organic residue left on a surface which could potentially contaminate the next manufacturing run.
Environmental monitoring programs can be used to identify hotspots, check the validity of food safety programs and indicate trends. It can be used to control, and find trending out of control (early warning), or requiring corrective action. It can give a rapid indication of the sanitary condition of the lines.
If environmental testing detects an environmental pathogen or an indicator organism on a product contact surface, then the facility may consider conducting end-product testing to determine if the product was contaminated.
For an FDA Food Safety Plan, the focus is on pathogens, and making sure that pathogens are not in the finished product. Therefore, an environmental monitoring program used to verify sanitation and other environmental controls must seek out pathogens.

How to decide if pathogen environmental monitoring programs (PEMPs) is required?

Not all food manufacturers are required to test the environment for pathogens. To determine if PEMP is necessary and which organism to monitor, a thorough risk evaluation should be conducted.
Timothy Freier and Joseph Shebuski  write about the fact that in ready-to-eat (RTE) perishable refrigerated products (e. g., deli-meat, salads, certain soft cheeses, cooked seafood, fresh-cut produce and hot dogs) L. monocytogenes has the greatest risk. In RTE that are shelf stable (e.g., nuts, nut butters, soy products, dry pet food, breakfast cereals, snacks, chocolate), Salmonella PEMP has the best value.
Salmonellosis has also been linked to raw unpasteurized products such as meat, poultry, eggs, dairy, grains, spices, and produce. However, these product contamination events were caused by the inherent presence of the pathogen in the raw products, and not by contamination originating from food manufacturing facilities. Salmonella PEMP is typically not necessary in facilities manufacturing these types of non-RTE products.

Evaluation of Results

The most important element of PEMP is the result evaluations, which should be done in a timely manner. If positives are found the results should be reviewed and corrective action must follow.The corrective action should target the root cause of the contamination. It should not only include re-cleaning or re-sanitizing of the areas found positive. It should include activities to achieve a permanent fix such as facility modification and process changes.

The 4 Zones

Zones are defined based on the probability of product contamination if a pathogen is present in the zone.
A pathogen in zone 1 is certain to contaminate the product. For inspections focusing on the presence of Salmonellae, food contact surfaces are normally not sampled. In contrast, for inspections focusing on detection of Listeria monocytogenes, sampling of food contact surfaces is essential. Many companies do not test zone 1 because it is likely too late for prevention and will likely mean a need to recall the product.
Zone 2 , the areas directly adjacent to Zone 1. For investigations focusing on Salmonellae, this is the area where environmental contamination is most likely to directly affect safety of the product and consequently it is the main focus for PEMP.
Zone 3 is the area immediately surrounding Zone 2. Zone 3, if contaminated with a pathogen, could lead to contamination of Zone 2 via actions of humans or movement of machinery.
Zone 4 is the area immediately surrounding Zone 3, if contaminated with a pathogen, could lead to contamination of Zone 3 via the actions of humans or machinery.
As mentioned above many companies do not usually test Zone 1 because it is likely too late for prevention and will likely mean a need to recall the product. The sampling should focus on Zone 2 because it has greater access to the food product and warm and wet areas that encourage bacterial growth. Zone 3 is tested less that zone 2. Very few, if any, environmental samples should be taken from Zone 4.
Any pathogen detection in zones 1-3 need to be addressed by corrective action.

Final thought

The food industry is doing more PEMPs because the regulators are testing the environment in the plans. The industry needs better understanding on how pathogens move in a plant to prevent their spread.
If a result comes back positive for a foodborne pathogen, production of the product may need to be put on hold and more testing may need to be done. In some cases, the product may even need to be reprocessed or destroyed completely.  

Salmonella outbreak due to consumption of seaweed

limu-pokeThe Hawaii State Department of Health is investigating 14 cases of Salmonella infection on Oahu. The infection is linked to raw fish called limus Poke (a raw fish salad containing seaweed Limu). Seaweed is frequently served as a side dish at meals in the Pacific Islands and is a common component in the diet of many persons living in the Pacific Rim. Seaweed is often harvested at beaches, gathered in near shore waters, or purchased at local markets.
Reported cases include both children and adults. All of the cases developed diarrheal illness from mid- to late October and four have required hospitalization.
The tainted limu has been linked to a seaweed farm on Oahu which was ordered by the department to halt operations and advise its customers to remove product from sale immediately. The preliminary investigation identified the consumption of raw fish, specifically poke that contains limu, as a common element among cases.
State Epidemiologist Dr. Sarah Park said: “Although our investigation is still ongoing, our preliminary investigation has implicated limu, also known as seaweed, produced at a particular farm on Oahu,” she also said that “We found that the limu was being sourced from one farm. Moving on a hunch, while still looking at other sources of contents, we collected samples” from the farm, which tested positive for salmonella. “Whether it turns out to be different or the same (strain), it should not have come back positive,” Park said.
According to Hawaii News Now the problem seaweed came from Olokai Hawaii, a seaweed farm in Kahuku. The owner, Dr. Wenhao Sun, said tainted water used in aquaponics may be to blame. Dr. Sun says in 10 years of operations, his farm has never experienced problems like this. “We will learn more and we will find the problem,” he said. “Then we can move on so we will satisfy our customers and make sure all the food is safe.”
“If you’re going to consume limu, make sure that it is cooked appropriately,” said Park. “Do not eat it raw at this point because unfortunately, we don’t know the scope of the distribution, so we don’t know which limu is okay and which limu is not.” 
This outbreak could have been prevented if the water in the seaweed farm would have been tested for pathogens.