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Cyclospora Infections are up this Summer Sickening Nearly a 1,000 Persons in 36 States

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The CDC Report

The CDC reported that since the beginning of 2017 to mid-September there have been 988 Laboratory confirmed cases of Cyclospora infected people in 36 states of the USA. The number of cases this year is significantly higher than in 2016.
The states with the most cases are Texas 28.8%, Florida 12.0%, and New York (including NYC) 10.6%.

Historical View

While the number of cases is higher this year, the director of CDC’s Division of Parasitic Disease, Dr. Monica Parise, said: “The numbers from this year were probably not outside the range that we’ve seen for the last five years,” According to Parise the numbers last year were low.
The CDC claims that it is not unusual to see an increase in Cyclospora infection in the US between May and September. However, as the table shows the increase this year seems to be outside the norm.   In the last decade, only in 2005, the number of cases came close to this year, with 582 people sick in Florida. The outbreak source was identified as basil from Peru.

Reason for the Outbreak

Currently, no specific product has been connected to the infections, and it is unclear if the various cases in the different states are related to each other. The specific vehicles of the infections have not been identified and the sources are being investigated. The CDC report claims that “It is too early to say whether cases of Cyclospora infection in different states are related to each other or to the same food item(s).”

The EPI Curve

The EPI curve shows the progression of illnesses in an outbreak over time. It shows when people become ill by day. There is an inherent delay between the date that an illness starts and the date when the case is reported to public health authorities.  For the Cyclospora outbreaks in 2017, the following curve was generated by the CDC
*N=553. Data are current as of 9/13/17.  These cases occurred in persons with no history of travel outside of the United States or Canada in the 14 days before onset of illness. Illnesses that began after Aug. 2 may not yet have been reported to CDC because of the lag time between a victim’s first doctor visit, lab tests, paperwork and finally reports being filed with public health agencies. 

Cyclosporiasis

Cyclosporiasis is an intestinal illness caused by the unicellular parasite Cyclospora cayetanensis. According to the CDC, People can become infected with Cyclospora by consuming food or water contaminated with the parasite.
The oocysts shed in the feces of infected persons must sporulate outside the host, to become infective for another person. Therefore, it is not transmitted usually from person to person, but through food or water. The sporulation process requires days to complete.
Cyclospora is by and large found in tropical and subtropical countries. It is normally not killed by most chemical disinfectants.
Products that historically caused outbreaks include fresh produce: basil, cilantro, lettuce, raspberries and snow peas.

Questions

Why do we see a higher number of infections despite FDA preventative measures?
Due to a number of outbreaks traced to fresh cilantro from the region of Pueblo, Mexico, the FDA increased inspection and enforcement there. According to the FDA “Beginning in 2015, from April 1 through August 31, cilantro from this region has been and continues to be detained without physical examination at the U.S.-Mexican border and refused admission into the United States.”
The FDA suggested in September 2016 that the lower number of infections that year correlated with the first full season that the FDA’s Import Alert for fresh cilantro from Puebla was in effect. Therefore, the question should be asked why we see such an increase this year.
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FDA Commissioner Announced a Four Year Delay in Implementing Some Produce FSMA Rules

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In a speech in front of National Association of State Departments of Agriculture (NASDA), Dr. Scott Gottlieb, the FDA commissioner outlined some immediate steps to facilitate the implementation of the Produce Safety Rule established by the FDA Food Safety Modernization Act (FSMA).
Dr. Gottlieb claims that since being in his post, he gained a deeper appreciation for the challenges and complexity that the globalized farming community is facing.

Agricultural Water Compliance Dates

He announced that the FDA issued a proposed rule that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts).  The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms would have until January 26, 2023, and very small farms January 26, 2024.
Sprouts, because of their unique vulnerability to contamination, remain subject to applicable agricultural water requirements in the final rule and their original compliance dates. 
He agreed that “microbial quality standards for agricultural water are too complicated, and in some cases too costly, to be effectively implemented.” Dr. Gottlieb also announced that “our intention to explore ways to simplify our approach to make compliance less burdensome and less costly, while still being protective of public health.”
To give the agency and the farmers more time, he is issuing an extension in the compliance dates” for the agricultural water requirements of the produce rule for non-sprout produce by an additional two to four years. This way the earliest non-sprout compliance date for the water standards won’t be until January 2022.”
The proposed extension will give the agency time to take another look at the water standards to ensure that they are feasible for farmers in all regions of the country while protecting public health. The agency has also increased the number of methods that can be used for water testing in agricultural water.

Educational Efforts

Dr. Gottlieb declared that the agency has recognized a need for additional efforts to educate the produce industry and state regulatory agencies on the new produce safety requirements, and will continue its focus on training, guidance development, and outreach over the next year. This is particularly important since the nation’s farming community has not previously been subject to this kind of oversight.
The FDA plans to learn more from farmers, state regulatory partners and other stakeholders about the diverse ways water is used and ensure that the standards will be as practical and effective as possible for all farming operations, during the time extension afforded by the extension.

Produce Inspection

The State Produce Implementation Cooperative Agreement Program that supports 43 states in their development of produce safety programs was awarded $30 million. This funding is in addition to on the nearly $22 million that FDA awarded last year to 42 states to develop produce programs and provide training and technical assistance.
Dr. Gottlieb assured the audiences that routine inspections would not begin until 2019. The additional time should be used to focus on issuing guidance that will be helpful to regulators and farmers.

On Farm Readiness Reviews

The farm readiness review is a voluntary program, where the farms are visited by a team of state officials, cooperative extension agents, and FDA produce experts.  The purpose of the visit is to give the farmers information about their readiness to meet the program requirements. The program will also help the FDA to identify training gaps that will be needed to be filled.

Training

Dr. Gottlieb claimed that through Produce Safety Alliance (PSA) 176 farmer training courses had been conducted in 36 states as of June of 2017. More than 1,000 trainers were trained in these courses. NASDA-FDA working group was formed to work on plans for training state and federal inspectors and is finalizing the training modules.
FDA is also working with NASDA to determine the best training platforms for ensuring that cooperative extension agents can have the training they need to be effective. Training of state regulators will be a top priority for the FDA in 2018.
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Updates: Botulism in Nacho Cheese, Salmonella in Maradol Papaya, Listeria in the Environment, and Our New Trending Page

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California Department of Public Health confirms that botulism outbreak was Linked to Retail Practices

In May we reported on a Botulism outbreak resulting from the consumption of nacho cheese sauce served at the Valley Oak Food and fuel gas station in Walnut Grove, California.
The outbreak included 10 cases of laboratory confirmed C. botulinum toxin type A. All patients were hospitalized and one death was reported. Customers spread the nacho cheese sauce on chips from a counter-top self-service warming dispenser.
According to a memo from the California Department of Public Health, the operators at the gas station were mainly responsible for the outbreak because the reasons for the outbreak were:
  • The bag of nacho cheese (5 lb) collected at the retail location on May 5, 2017, was consumed past the “Best By” date.
  • The gas station did not maintain records of the time in which the bag nacho cheese was added to the warming unit. Therefore, the cheese might have been left too long in the warmer.
  • The designated tool to open the nacho cheese bag was not used to open the bag of cheese.
The CDPH Food and Drug Branch (FDB) and Sacramento County Environmental Management Department (SCEMD) guided management in such retail store regarding the use of nacho cheese warming and dispensing machines in retail locations, in order to prevent future incidents like this one in the future. 

Multistate Outbreak of Salmonella Anatum Infections Linked to Imported Maradol Papayas

The CDC reports on the newest outbreak relating to papayas from Mexico.  This is the fourth investigation involving to papayas from Mexico this year.
On September 4, 2017, the CDC reported that 14 people in 3 states were infected with the outbreak strain of S. anatum. Five hospitalizations and one death resulted from this outbreak.  Epidemiological and laboratory data indicated that papaya from Mexico imported by Bravo Produce Inc. of San Ysidro, California is the probable source of the outbreak.
On September 10, the FDA and the distributor withdrew the product from the market. The CDC pulseNet data base identified 6 more individuals with the same DNA fingerprint that recently became ill.

Environmental sampling of a plant in Germany linked to Listeria Outbreak

With the increase in environmental sampling mandated by the FSMA, and the numerous recalls resulting from the program, I find it interesting that environmental sampling was inked to a Listeriosis outbreak in Germany.
A conveyor belt in a meat processing plant, moving product before packaging, was most likely the source of the contamination.
In 2015, an outbreak of Listeriosis was reported in Germany, caused by L. monocytogenes ½ a.  In Emerging Infectious Diseases Volume 23, Number 10—October 2017, Molecular Tracing to Find Source of Protracted Invasive Listeriosis Outbreak, Southern Germany, 2012–2016 Kleta et al. using forensic microbiology, had identified several products from one manufacturer contaminated with the outbreak genotype Listeria.
Their conclusion was based on the facts that:
  • L. monocytogenes outbreak strain was isolated from several products of the same manufacturer
  • The outbreak strain was absent in other products collected during the same period
  • Epidemiological findings suggested that the source of the outbreak was from this single factory
  • The meat processing plant predominantly supplied grocery stores of a single company
  • Patience food consumption histories were compatible with the molecular typing results
However, the authors could not prove the producer was the source of the infections. They concluded that public health could benefit from continuous molecular surveillance of isolates from humans and food, which could allow for infectious disease outbreaks to be stopped before emergence.

New Trending Page in BioExpert

We are planning to add a new exciting page in our ask-bioexpert site. The purpose of this additional page is to introduce and discuss current trends in food safety, intriguing articles, and bring to the attention of the food safety community any new topic that might be of interest.  Any registered user will be able to quickly describe any relevant trend or comment on any previously published trend descriptions.
I am hoping that all registered users will contribute to this page thereby creating a compelling new relevant body of information and pointing readers to valuable food safety information. By your active participation, you will be able to help your colleagues to understand the most pressing trends in food safety and determine where to focus their attention.
 
Please look for an announcement soon.
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Food Recalls due to Listeria monocytogenes in the News Again

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As we reported earlier Listeria monocytogenes was a major reason for recalls according to “summary of recall cases in Calendar Year 2016”, by the FSIS/USDA, accounting for over 80% of the pathogen recall cases. Currently, this trend is continuing, with many recalls due to L. monocytogenes.

Hillcrest Dairy in Moravia NY

The New York State Department of Agriculture urged consumers in Cayuga County not to consume raw milk cheeses (“Old Fashioned Raw Milk Monterey Jack,” “Horseradish Monterey Jack,” and “Chipotle Adobo Monterey Jack”) made by Ripley Dairy LLC, from Moravia, New York because they might be contaminated with Listeria. The products are packaged in a plastic shrink-wrapped and marked with Hillcrest Dairy name and were made from raw milk.
The NY Department of Agriculture announcement claimed that “A routine sample of the cheese, taken by an inspector from the Division of Milk Control and Dairy Services on August 9, 2017, was subsequently tested by the New York State Food Laboratory and tested positive for Listeria monocytogenes.  On August 11, 2017, the manufacturer was notified of a preliminary positive test result and voluntarily recalled the product from all their customers.  Test results were confirmed on August 17, 2017.  The cheese will be destroyed by the manufacturer.”
 To date, no illnesses associated with this product have been reported to the Department. 

Expresco Foods Inc Montréal, Québec

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS/USDA) announced that the company recalled approximately 20,446 pounds of imported, fully cooked chicken skewer products that may be contaminated with Listeria monocytogenes. American authorities found Listeria monocytogenes during a routine foreign shipment inspection.
The recall includes both Expresco and West End Cuisine brand chicken kabobs. Expresco produced the products between Aug. 9 and 15. The products were distributed to retail locations in Arizona, Connecticut, Florida, Illinois, Maryland, Michigan and Texas.  There have been no confirmed reports of adverse reactions due to consumption of these products.

SunOpta, a subsidiary, Sunrise Growers in Kansas

The FDA announces that SunOpta Inc’s subsidiary, Sunrise Growers Inc. is issuing a voluntary recall of frozen organic dark sweet pitted cherry products due to the potential to be contaminated with Listeria monocytogenes.
 
The recall includes frozen organic dark sweet pitted cherry products distributed from Sunrise Grower’s facility in Edwardsville, Kansas on August 10, 2017. The contamination was discovered during routine testing.
Ninety cases of Great Value, Organic Dark Sweet Pitted Cherry products, were recalled.  The products are packaged in 32 ounce printed plastic zip top bags. Some of the products were packaged under Walmart’s Great Value brand. These recalled products were distributed to a customer distribution center in Louisiana and may have been redistributed to stores in Louisiana and Mississippi.  
No illnesses related to the consumption of these products have been reported.

Fair Oaks Farms, LLC, Pleasant Prairie, Wisconsin

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS/USDA) announced that the company is recalling approximately 1,134 pounds of fully cooked pork sausage patties that may be contaminated with Listeria monocytogenes. The fully cooked pork sausage patties were produced on August 8, 2017.
The contamination was discovered by Oaks Farms during routine testing. The products were put on hold at a distribution center but inadvertently they were shipped. The products were shipped to distribution and retail locations in Illinois, Iowa, and Wisconsin.
While no adverse reaction was reported, FSIS and the company are concerned that some product may be frozen and in consumers’ freezers.
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Beef Products Recalled due to Possible E. coli O26 Contamination

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The Recall

The Department of Agriculture’s Food Safety and Inspection Service (FSIS-USDA ) announced that Good Food Concepts, LLC., a Colorado Springs, Colorado recalled 1,290 pounds of raw beef products, processed Aug. 3 and Aug. 4, 2017, due to potential contamination with E. coli O26.
The contamination was discovered on Aug 5, 2017, by the company who had notified the FSIS inspection.  A lot of carcasses received from Callicrate Ranch on July 31, 2017, were found to be contaminated with STEC (Shiga toxin producing E. coli) E. coli O26.
Good Food Concepts company and FSIS are concerned that some beef may have been frozen and in consumers’ freezers.

Pathogenic E. coli

The most prevalent strain of E. coli causing recalls and illnesses is E. coli O157:H7. However, there are seven serotypes of E. coli that cause most of the food recalls and diseases, called the Top 7. They include: in addition to O157:H7 also O26, O45, O103, O111, O121, and O145.

E. coli O26

In the recent past, E. coli O26 resulted in several recalls and illnesses.  E. coli O26 is one of the six most common strains of non-O157 E. coli found to cause foodborne illnesses. 
It is difficult to identify in the laboratory the O26, in particular by the new rapid methods, because most laboratories are looking specifically for E. coli O157:H7. However, it is a pathogenic strain that caused disease. E. coli STEC O26 shows that the extensive genetic diversity and pathogenic clonal subgroups can emerge soon.

Disease Symptoms

Symptoms usually begin two to eight days after exposure. People infected with O26 often develop bloody diarrhea, dehydration, and abdominal cramps. Most people recover within a week. However, some patients can develop hemolytic uremic syndrome or HUS. Children and older people, with suppressed immune systems, are more susceptible to HUS.

Recall due to E. coli O26 by Costco in Canada

The Canadian Food Inspection Agency (CFIA) announced a few days ago that Costco Wholesale Canada Ltd. recalled Gold Coast brand Broccettes – Broccoli Florettes due to possible E. coli O26 contamination. The products had been sold in British Columbia, but no illnesses were reported in association with these commodities.

Previous Recalls Due to E. coli

E. coli O26 and O21were found in flour from General Mills. The FDA investigation identified General Mills flour as the source of this outbreak which led to a voluntary recall in May 2016. On September 29, 2016, the CDC reported (https://www.cdc.gov/ecoli/2016/o121-06-16/index.html) that 63 people were infected with the outbreak strains of E. coli O121 and O26 in 24 states. Illnesses started on dates ranging from December 21, 2015, to September 5, 2016. Seventeen ill people were hospitalized, and one person developed the hemolytic-uremic syndrome.

Multistate Outbreak of E. coli O26 Infections Linked to Chipotle Mexican Grill Restaurants

The FDA  and the Centers for Disease Control and Prevention (CDC) along with state and local officials investigated two separate outbreaks of E. coli O26 infections. Both were linked to Chipotle Mexican Grill restaurants in several states
The CDC reports indicated that as of January 27, 2016, a total of 55 people had been infected with the outbreak strain of E. coli O26. Eleven states were involved: California (3), Delaware (1), Illinois (1), Kentucky (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (2), and Washington (27). There have been 21 reported hospitalizations. The majority of these cases were reported from Oregon and Washington during October 2015.
Chipotle Mexican Grill closed 43 restaurants in Washington and Oregon in early November 2015 in response to the initial outbreak. 

National Meat and Provisions Recalls Beef and Veal Products Due To Possible E. Coli O26 Contamination

The FSIS-USDA announced the recall of approximately 2,349 pounds of beef and veal products that may have been contaminated with E. coli O26, on Oct. 14, 2016. The products were shipped to a distributor, as well as hotels, restaurants, and other institutions in Louisiana.
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FSMA and Pathogen Environmental Monitoring (PEM) Programs: Where are we?

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Environmental monitoring is required under CFR 21 section 117.165 and under the FDA Final Rule for Preventive Controls for Human Food. Its purpose is to verify the implementation and effectiveness of the preventive controls put in place. Most food companies need to comply with these rules now or in the very near future.

Purpose of the PEM Program

The reason for having a PEM program is to identify problematic areas in the manufacturing facility where pathogens can harbor and become a source of contamination (“niches”), and assess the effectiveness of the sanitation programs.
Environmental monitoring may include pathogens or indicator organisms, depending on the products being manufactured. The program should encourage finding locations that will yield positive pathogen results, with the idea that “If it’s there and you don’t find it, FDA will.”
Another goal of the program is to prevent cross contamination or recontamination of the product from the environment. Positive results need to be followed with root-cause analysis, and the results need to be used immediately for corrective actions as well as long term improvements.  

The Zone Concept

Zones are defined based on the probability of product contamination.
If a pathogen is present in environmental samples from zone 1, it is likely to contaminate the product. Food contact surfaces are usually not sampled for Salmonellae. In contrast, it is essential to test food contact areas for Listeria monocytogenes.
Zone 2 is the main focus for PEM investigations of Salmonellae since it is where environmental contamination is most likely to influence the safety of the product.
Zone 3, if contaminated with a pathogen, could lead to contamination of Zone 2 via actions of humans or movement of machinery.
Zone 4, if contaminated with a pathogen, could lead to contamination of Zone 3 via the actions of humans or machinery.
Any pathogen detection in zones 1-3 needs to be addressed by a documented corrective action.

When and Where to Test

When: Pre-op areas are less likely to yield positive samples. However, if found it is more easy to interpret and will identify sanitation weaknesses. 
Three to four hours after the initiation of processing, it is more likely to find swabs that are positive for pathogens. It might provide information on the spread of the pathogen during processing.  Site in which pathogens are detected requires pre-op follow-up sampling to identify pathogen source/niche.
 
Where to test: In niches such as hollow rollers, table legs, floor wall junctures, floor cracks, areas that are difficult to clean, seals on doors, transfer points such as door handles, and operator’s hands. 

What are Reported FDA Actions?

For facilities that produce Ready-to-Eat products, it is common for the FDA to perform intensive swabbing of the manufacturing site, termed by some “swab-a-thon.” The team of FDA investigators will take samples in hard to reach areas, which are difficult to sanitize.
The FDA investigators are instructed to take hundreds of samples, focusing on Salmonella swabbing in Zones 2 and also collect a few samples in zones 3 and 4; The Listeria swabbing focus is on zones 1 and 2. In some recent swab-a-thons numerous samples were collected in Zones 3 and 4, and positive pathogen findings in these areas led to some recalls.
One goal of the program is to sequence the environmental pathogens found and compare them to stains that have caused illnesses. Another goal is to find “persistent” strains that are persisting in the manufacturing environment. Finding such strains could suggest that the corrective action is inadequate, and could result in a recall.  Alternatively, it could mean that the same strains are re-introduced to the facility due to raw ingredients.
Many recalls have resulted from detection of pathogens in the environment. With whole genome sequencing Listeria outbreaks can be detected when only two people have gotten ill from a certain product. Finding that the same strain of Listeria is making people sick is an indication that these illnesses may have originated from the same source. Additionally, positive samples resulting from these swab-a-thons may cause costly product recalls, and a cease in operations until the pathogen has been eliminated. Also, the positive sample’s DNA will be cross-referenced with the PulseNet Database to see if it matches a strain linked to an illness.

Seek and Destroy

The complete elimination of L. monocytogenes from post processing contamination is difficult because: (i) this pathogen is common in various environments outside processing plants; (ii) it can endure in food processing environments for years.
Essentially, the “seek and destroy” process is to disassemble the equipment, and during disassembly, to evaluate the equipment for growth niches. If growth niches are discovered during the process, a microbiological assessment of those areas is conducted.
Because of the impact of a pathogen being found in Zone 1, it is preferred to comprehensively and systematically monitor Zones 2 and 3. These areas should be tested with the end goal to seek and destroy any pathogen present. This approach requires digging into hard-to-reach places and look for problems. Seek to find and destroy any issues in Zones 2 and 3 before they can hit Zone 1.
If a pathogen or indicator organism is found in Zone 2 or 3, the faster it is detected and corrected, the less likely it is to have implicated product. This call for a systematic approach to finding niches in the food processing plant where growth can occur, and either eradicate or mitigate effects of these niches.

Need for Rapid Testing Methods

The faster results can be obtained after sample collection, the quicker you can destroy the potential of food contact surface contamination, and prevent the potential of product contamination.
Using newer and faster molecular based technology for detection, rather than traditional 48-hour or longer methodologies, enables faster response to positives, and quicker remediation through sanitation. It also helps to prevent the transfer from zone to zone including transfer onto food contact surfaces of Zone 1.
Several such new methods are just coming to the market and will be discussed in future blogs.

What to do With the Test Results

A trend needs to be established, and after that, it should frequently be reviewed to identify trends (e.g., site that has positives with negatives due to intervention). Documented corrective action is required for any positive sample.
If there is a trend of increased frequency of pathogen detection by the swabs, it needs to be investigated to determine the reason and the action to be taken to reduce this frequency. Samples showing positive pathogen results should be followed up with additional investigations and root-cause analyses. Additionally, the cleaning and sanitation need to be intensified (“deep cleaning”).
If an area shows repeated positives, it is a potential harborage or problem area and will require attention until cleared.  Corrective action must be implemented and documented. There must be a prearranged plan that will be implemented if a positive pathogen is detected. The plan should be zone specific.   If a positive pathogen result is found in any zone, the area needs to be thoroughly examined both visually and through vector swabbing (see below) to determine the extent of the contamination and to ascertain potential causes of the problem.

Vector Swabbing

If a location results in a positive sample, vector swabbing is required. This means taking multiple environmental samples around the initial positive site. Vector sampling is usually done in a typical “star-burst” pattern around the initial positive site as shown in the figure below. Additional 10-15 swabs samples are taken around the initial positive sample.

Adopted from “Pathogen Environmental Monitoring program (PEM)” 

Corrective Action

The specific corrective actions should be based on an evaluation of the likelihood of finished-product contamination based on the location of the initial positive site. A positive finding in Zones 2, 3 or 4 does not necessarily implicate finished product contamination. That decision should be made by the team and appropriate management personnel.
Corrective action should target the root-cause of the contamination. The food safety team should consider what changes (e.g., in personnel, training, equipment, process) will result in a permanent fix for the problem.
After the corrective action, additional testing may be necessary to verify the satisfactoriness of the corrective actions and to validate that the pathogen was eliminated from the area. All activities involving the corrective action should be documented.