Tag Archives: FSIS

Salmonella Surveillance

Mid-Year Pathogen Surveillance and Inspection Update

By Nathan Libbey
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Salmonella Surveillance

Food Recalls

The first half of 2021 saw almost a 20% increase in recalls vs. the last 6 months of 2020 (117 vs. 96). According to a recent report by Lathrop GPM, LLC, food producers have seen an increase in food safety incidents since the pandemic began, and expect an ongoing increase over the next year.1 A majority of recalls were due to undeclared allergens or potential for allergen cross contamination. Second to allergens were potential for microbiological contaminants, including Salmonella, Listeria, E. coli, and Cyclospora.

FDA Recalls Recalls
Figure 1 and 2. The first half of 2021 saw a 26% increase of facility inspections by the FDA. Despite this jump, inspections in the first half of 2020 were 80% higher than this year’s first six months. Source: FDA Recalls, Market Withdrawals, & Safety Alerts.

Inspection Results

The first half of 2021 saw a 26% increase of facility inspections by the FDA. Despite this jump, inspections in the first half of 2020 were 80% higher than this year’s first six months. Inspections generally lead to three outcomes; No Action Indicated (continue as you were,) Voluntary Action Indicated (voluntary to make some changes), or Official Action Indicated (OAI) (Regulatory Actions will be recommended by the FDA). A majority of inspections (56%) resulted in NAI this year, compared to 59% and 50% in the first and second halves of 2020, respectively.

Facility Inspections
Figure 3. Facility Inspections. Data from FDA.

Salmonella Surveillance

The FSIS provides ongoing surveillance of Salmonella and Campylobacter presence in poultry, both domestic and imported. Salmonella is reported by facility and each is given a category rating of 1–3. One is exceeding the standard (based on a 52-week moving average), two is meeting the standard, and three is below standard. For the 52-week reporting period ending May 30, 2021, 60% achieved category one, compared to 56% the previous 52 weeks.

Salmonella Surveillance Salmonella Surveillance
Figures 4 & 5. Salmonella surveillance data from FDA.

Listeria and Salmonella Surveillance in RTE Meat and Poultry

USDA FSIS conducts periodic sampling of Ready to Eat (RTE) meat and poultry products and reports quarterly results. Sampling is conducted both in a random fashion as well as based on risk-based sampling. In Q2 2021, 4769 samples were tested for Listeria, compared to 4632 in Q1.

Percent positive rates were .36% for Q2 and .43% for Q1. Neither quarter reported any positives for Listeria in imported RTE Meat and Poultry Products.

Salmonella samples for RTE totaled 3676 in Q2 2021, compared with 3566 in Q1. In both quarters, only 1 positive was found in the samples collected.

Routine Beef Sampling for E. coli 0157:H7 and STEC

The FSIS also conducts ongoing routine sampling of beef products for E. coli. E. coli is further classified into 0157:H7 and non-0157:H7 Shiga toxin-producing E. coli (STEC). In Q2 of 2021, 4467 samples were collected and tested for 0157:H7 versus 4268 in Q1. Of these, three were positive, compared to seven positives the preceding quarter. For STEC, a total of 8 positives were found, compared to 1 positive in Q1. No positives were found in imported goods in Q2, although in Q1 2021, 4 positives for STEC were found.

Conclusion

The first half of 2021 showed an increase in activity, which is on par with food industry survey data. Food recalls have increased, with food allergens remaining the most prevalent reason for recall or withdrawal. While inspections also increased, they have not returned to pre-pandemic levels. The impact of the spread of the Delta variant and increased restrictions is yet to be seen, but inspection activity will likely not rebound entirely by the end of the year. Pathogen tests by FSIS increased quarter over quarter for Salmonella, E. coli, and STEC, with mixed results in prevalence.

Reference

1. Lathrop GPM, LLC. (2021). Food Processing Trends, Outlook and Guidance Report. Retrieved from https://www.lathropgpm.com/report-agribusiness.html

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FSIS Revises Guidelines for Controlling Salmonella and Campylobacter in Raw Poultry

By Food Safety Tech Staff
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Register to attend Food Safety Hazards: Salmonella Detection, Mitigation, Control & Regulation | Thursday, July 15, 11:45 am ETFSIS has announced revised guidelines to help poultry facilities control Salmonella and Campylobacter in raw poultry. The changes are a result of new scientific and technical information, public comments, and FSIS’s decision to separate the guidelines into one on controlling Salmonella and one on controlling Campylobacter. The guidelines, “Availability of Revised Compliance Guidelines for Controlling Salmonella and Campylobacter in Raw Poultry”, also provide best practices for poultry establishments.

“FSIS has updated the guideline contents to reflect the most recent best practices, supported by current peer-reviewed literature and analyses of FSIS data,” the agency stated in a news release. “Updates include information on using neutralizing agents in sampling to prevent carryover of antimicrobial substances and a current list of antimicrobials for establishment use. Also included are improvements in the information on pre-harvest practices, with a comprehensive revision of the litter/bedding section.”

A copy of the docket is available on the Federal Register.

Tyson Foods, Chicken Recall, Listeria

Tyson Foods Recalls More Than 8 Million Pounds of RTE Chicken Due to Potential Listeria Contamination

By Food Safety Tech Staff
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Tyson Foods, Chicken Recall, Listeria
Tyson Foods, Chicken Recall, Listeria
One of the recalled RTE chicken products from Tyson Foods. Labels of recalled products are available on the FSIS website.

Tyson Foods, Inc. is recalling 8,492,832 pounds of ready-to-eat (RTE) chicken products over concerns that the product may be adulterated with Listeria monocytogenes. The Class I recall affects frozen, fully cooked chicken products that were produced between December 26, 2020 and April 13, 2021, and shipped nationwide to retailers and facilities that include hospitals, nursing homes, restaurants, schools and Department of Defense locations. The recalled products bear establishment number “EST. P-7089” on the product bag or inside the USDA mark of inspection.

Thus far three people have been sickened with Listeriosis, and one death has been reported, according to the CDC investigation.

The FSIS website lists all products affected by the recall—which includes diced chicken, frozen, fully cooked chicken strips, diced chicken, chicken used for fajitas chicken wing sections, and pizza with fully cooked chicken.

The CDC is advising that businesses do not serve or sell recalled products, and that any refrigerators, containers or surfaces that may have touched the recalled products be thoroughly cleaned.

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FSIS Changes Mask, Social Distancing Requirements Effective Immediately

By Food Safety Tech Staff
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Following CDC’s latest guidance announcing that fully vaccinated people can resume activities without wearing a mask or social distancing, FSIS issued new guidance for agency personnel in plants, laboratories and in-commerce.

Effective immediately, personnel fully vaccinate (at least two weeks past the final dose of the COVID-19 vaccine) are not required to wear a face mask, face shield or practice physical distancing in federal establishments, facilities that request voluntary inspection, labs or where in-commerce work is conducted. However, fully vaccinated personnel can continue to wear face masks or shields if they so desire.

Personnel that is not fully vaccinated must continue to wear a face mask or shield and maintain social distancing requirements as mandated by the agency.

Recall

JBS Recalls Nearly 5000 Pounds of Imported Australian Boneless Beef Due to Potential E. Coli Contamination

By Food Safety Tech Staff
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Recall
JBS Boneless Beef product
Label of recalled JBS Australia beef product. (Image from FSIS)

JBS USA Food Company is recalling about 4,860 pounds of imported raw and frozen boneless beef products over concern of contamination with E. coli O157:H7. The products were imported on or around November 10, 2020 and shipped to distributors and processors in New York and Pennsylvania.

The issue was uncovered during routine product sampling collected by FSIS, which confirmed positive for the presence of E. coli O157:H7, according to an FSIS announcement. “FSIS is concerned that some product may be frozen and in cold storage at distributor or further processor locations,” the announcement stated. “Distributors and further processors who received these products are urged not to utilize them.”

No illnesses or adverse reactions have been reported.

Tucson Tamale

USDA Issues Public Health Alert for Tamales Due to Potential Foreign Matter Contamination

By Food Safety Tech Staff
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Tucson Tamale

Yesterday USDA’s FSIS issued a public health alert for ready-to-eat chicken and pork tamales because they contain recalled diced tomatoes in puree that have been recalled by the producer due to foreign matter contamination. The puree product is FDA regulated. The RTE tamales were produced by Tucson Tamale Wholesale Co., LLC between October 22 and November 9, 2020, and have the establishment number “EST. 45860” inside the USDA mark of inspection. The products were sold online and shipped for retail and restaurant distribution nationwide.

Tucson Tamale
Tucson Tamale recalled the above-pictured ready-to-eat tamales due to potential contamination with hard plastic.

Tucson Tamale uncovered the issue upon identifying pieces of hard plastic in the cans of diced tomatoes that they received from their ingredients supplier. FSIS is urging consumers who purchased the product to throw them away or return them to the place of purchase.

Mortadella

CDC, USDA Investigating Multistate Listeria Outbreak Linked to Italian-Style Deli Meats

By Food Safety Tech Staff
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Mortadella

On October 29, 2020 attend the Food Safety Consortium Virtual episode on Listeria Detection, Mitigation and ControlThe CDC and USDA are investigating a multistate outbreak of Listeria monocytogenes that has sent 10 people to the hospital and resulted in one death. The outbreak, which as of October 22 has reported illnesses in Florida (1), Massachusetts (7) and New York (2), has been linked to Italian-style deli meats such as salami, mortadella and prosciutto. Currently no specific deli meat or common supplier has been identified.

CDC, FSIS and other public health officials are using PulseNet to identify any illnesses that could be linked to the outbreak. The following is a link to the CDC’s map of reported cases by state.

Manuel Orozco, AIB International
FST Soapbox

Detecting Foreign Material Will Protect Your Customers and Brand

By Manuel Orozco
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Manuel Orozco, AIB International

During the production process, physical hazards can contaminate food products, making them unfit for human consumption. According to the USDA’s Food Safety and Inspection Service (FSIS), the leading cause of food recalls is foreign material contamination. This includes 20 of the top 50, and three of the top five, largest food recalls issued in 2019.

As methods for detecting foreign materials in food have improved over time, you might think that associated recalls should be declining. To the contrary, USDA FSIS and FDA recalls due to foreign material seem to be increasing. During the entire calendar year of 2018, 28 of the 382 food recalls (7.3%) in the USDA’s recall case archive were for foreign material contamination. Through 2019, this figure increased to approximately 50 of the 337 food recalls (14.8%). Each of these recalls may have had a significant negative impact on those brands and their customers, which makes foreign material detection a crucial component of any food safety system.

The FDA notes, “hard or sharp foreign materials found in food may cause traumatic injury, including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine, as well as damage to the teeth and gums”. Metal, plastic and glass are by far the most common types of foreign materials. There are many ways foreign materials can be introduced into a product, including raw materials, employee error, maintenance and cleaning procedures, and equipment malfunction or breakage during the manufacturing and packaging processes.

The increasing use of automation and machinery to perform tasks that were once done by hand are likely driving increases in foreign matter contamination. In addition, improved manufacturer capabilities to detect particles in food could be triggering these recalls, as most of the recalls have been voluntary by the manufacturer.

To prevent foreign material recalls, it is key to first prevent foreign materials in food production facilities. A proper food safety/ HACCP plan should be introduced to prevent these contaminants from ending up in the finished food product through prevention, detection and investigation.
Food manufacturers also have a variety of options when it comes to the detection of foreign objects from entering food on production lines. In addition to metal detectors, x-ray systems, optical sorting and camera-based systems, novel methods such as infrared multi-wavelength imaging and nuclear magnetic resonance are in development to resolve the problem of detection of similar foreign materials in a complex background. Such systems are commonly identified as CCPs (Critical Control Points)/preventive controls within our food safety plans.

But what factors should you focus on when deciding between different inspection systems? Product type, flow characteristics, particle size, density and blended components are important factors in foreign material detection. Typically, food manufacturers use metal and/or x-ray inspection for foreign material detection in food production as their CCP/preventive control. While both technologies are commonly used, there are reasons why x-ray inspection is becoming more popular. Foreign objects can vary in size and material, so a detection method like an x-ray that is based on density often provides the best performance.

Regardless of which detection system you choose, keep in mind that FSMA gives FDA the power to scientifically evaluate food safety programs and preventive controls implemented in a food production facility, so validation and verification are crucial elements of any detection system.

It is also important to remember that a key element of any validation system is the equipment validation process. This process ensures that your equipment operates properly and is appropriate for its intended use. This process consists of three steps: Installation qualification, operational qualification and performance qualification.

Installation qualification is the first step of the equipment validation process, designed to ensure that the instrument is properly installed, in a suitable environment free from interference. This process takes into consideration the necessary electrical requirements such as voltage and frequency ratings, as well as other factors related with the environment, such as temperature and humidity. These requirements are generally established by the manufacturer and can be found within the installation manual.

The second step is operational qualification. This ensures that the equipment will operate according to its technical specification. In order to achieve this, the general functions of the equipment must be tested within the specified range limits. Therefore, this step focuses on the overall functionality of the instrument.

The third and last step is the performance qualification, which is focused on providing documented evidence through specific tests that the instrument will performs according to the routine specifications. These requirements could be established by internal and industry standards.

Following these three steps will allow you to provide documented evidence that the equipment will perform adequately within the work environment and for the intended process. After completion of the equipment validation process, monitoring and verification procedures must be established to guarantee the correct operation of the instrument, as well procedures to address deviations and recordkeeping. This will help you effectively control the hazards identified within our operation.

There can be massive consequences if products contaminated with foreign material are purchased and consumed by the public. That’s why the development and implementation of a strong food safety/ HACCP plan, coupled with the selection and validation of your detection equipment, are so important. These steps are each key elements in protecting your customers and your brand.

Trish Wester
FST Soapbox

FDA Announces Inspections Will Resume…Sort Of

By Trish Wester
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Trish Wester

FDA Commissioner Stephen Hahn, M.D. recently announced that food safety inspections will resume in July, but inspectors will be given leeway to accommodate the coronavirus pandemic. Inspections will be prearranged by appointments. The agency suspended routine inspections in late March as a result of the pandemic response, which closed down much of the country.

USDA/FSIS has continued to provide inspection services for eggs, meat and poultry throughout the COVID-19 outbreak, with a significant number of establishments involved in outbreak clusters and periodic shutdowns.

The “White House Guidelines for Opening Up America Again” calls for the FDA to send out investigators for on-site inspections by the week of July 20, using the COVID-19 Advisory Rating system, which utilizes state and national data about infection rates to determine the regions where enforcement can resume.

In a July 10 FDA statement Hahn noted, “resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality, and the rules and guidelines that are put in place by state and local governments.”

One of the most significant modifications for domestic inspections in the announcement is that they will be pre-announced to FDA-regulated businesses. “This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff is on-site to assist FDA staff with inspection activities,” Hahn said. Previously, most inspections were unannounced.

It’s not entirely clear how FDA will use the White House guidelines to determine where they can schedule inspections. There is mention of a prioritization mechanism that will identify high-risk operations, but that has traditionally been part of FDA’s approach to inspections.

The CDC published phased guidelines for states to follow in reopening, which are referred to in the announcement. The guidelines document outlines the gating criteria for states, but published versions do not mention inspection requirements. Many states began reopening without meeting all of the gateway criteria for Phase 1, and continued to accelerate reopening activities in a way that makes it unclear which phase criteria they may have actually met when compared to the phase under which they claim to be operating.

Further complicating the safety issue is the recent rising number of COVID-19 cases that is causing some states to pause or rollback reopening activities. Since publishing the announcement, several states have emerged as new COVID-19 hot spots, including Texas, Arizona and Florida; In addition, Florida has surpassed New York in total cases. California, another food producing state heavily affected by the pandemic, is seeing a significant increase in cases and is considering issuing new shelter-in-place orders. It was recently reported that CDC has identified 21 states as “Red Zones”, with at least 11 states on the verge of surging cases.

In other words, with the virus on the rise, there may not be a significant number of inspections actually performed, regardless of whether or not inspections have technically resumed, simply because there just isn’t a safe way to send inspectors out.

The FDA has also published the “New Era of Smarter Food Safety Blueprint”, which includes ways the agency could use technology to support compliance activities. There may be an opportunity for the FDA to implement new tools such as remote verification in lieu of onsite inspections, but that remains to be seen. Among such tools, remote audit pilots were recently completed and those results will be available for public presentation at the end of August.

In the short term, should FDA determine you are an inspection candidate, you will contacted in advance to schedule a day and time.

Marketside Ground Beef

Nearly 43,000 Pounds of Ground Beef Recalled Due to Potential E. Coli Contamination

By Food Safety Tech Staff
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Marketside Ground Beef

Swedesboro, NJ-based Lakeside Refrigerated Services recalled about 42,922 pounds of ground beef products over concern of potential E. coli O157:H7 contamination. The Class I recall involves raw ground beef products that were produced on June 1.

The issue was uncovered during routine FSIS testing. The products were reportedly distributed to retailers, including Walmart, nationwide. Thus far there are no reports of adverse reactions due to consumption of the affect products.

A full list of the recalled products are available on the USDA’s website.