FDA has completed its investigation of the multistate outbreak of E. coli 0151:H7 that occurred last fall and was linked to leafy greens. The FDA and CDC found the outbreak was caused by an E. coli strain that was genetically related to the strain found in the fall 2019 outbreak involving romaine lettuce (Salinas, California). Despite conducting environmental sampling at dozens of ranches in the area, the FDA was unable to identify a single site as the source of the outbreak. However, the analysis did confirm “a positive match to the outbreak strain in a sample of cattle feces,” which was located uphill from where the leafy greens identified in the agency’s traceback investigation were grown, according to an FDA release.
Although the FDA’s investigation has ended, the agency will be reviewing the findings and release a report in the “near future” with recommendations. “In the meantime, as recommended in our Leafy Greens Action Plan, the FDA continues to recommend growers assess and mitigate risk associated with adjacent and nearby land use practices, particularly as it relates to the presence of livestock, which are a persistent reservoir of E. coli O157:H7 and other STEC,” FDA stated in the update.
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.
Remember the 2015 Listeria outbreak linked to Blue Bell Creameries? The outbreak led to three deaths and 10 illnesses between January 2010 and January 2015. On Thursday the Department of Justice ordered the company to pay $17.25 million in criminal penalties for shipping contaminated products linked to that outbreak. The sentence, enforced by U.S. District Judge Robert Pitman (Austin, Texas), is the largest fine and forfeiture ever imposed in a conviction involving a food safety case.
“American consumers must be able to trust that the foods they purchase are safe to eat,” stated – Acting Assistant Attorney General Jeffrey Bossert Clark, Justice Department’s Civil Division in an agency news release. “The sentence imposed today sends a clear message to food manufacturers that the Department of Justice will take appropriate actions when contaminated food products endanger consumers.”
In May 2020 Blue Bell pleaded guilty to two misdemeanor counts of distributing adulterated ice cream. The following is an excerpt from the Department of Justice news release:
“The plea agreement and criminal information filed against Blue Bell allege that the company distributed ice cream products that were manufactured under insanitary conditions and contaminated with Listeria monocytogenes, in violation of the Food, Drug and Cosmetic Act. According to the plea agreement, Texas state officials notified Blue Bell in February 2015 that samples of two ice cream products from the company’s Brenham, Texas factory tested positive for Listeria monocytogenes, a dangerous pathogen that can lead to serious illness or death in vulnerable populations such as pregnant women, newborns, the elderly, and those with compromised immune systems. Blue Bell directed its delivery route drivers to remove remaining stock of the two products from store shelves, but the company did not recall the products or issue any formal communication to inform customers about the potential Listeria contamination. Two weeks after receiving notification of the first positive Listeria tests, Texas state officials informed Blue Bell that additional state-led testing confirmed Listeria in a third product. Blue Bell again chose not to issue any formal notification to customers regarding the positive tests. Blue Bell’s customers included military installations.”
Last week OSHA cited Smithfield Packaged Meats in Sioux Falls, South Dakota for failing to protect its workers from COVID-19 exposure. The federal agency issued a fine of $13,494 and cited a violation of failing to provide a violation-free environment following an inspection. More than 1200 workers for Smithfield Foods have contracted COVID-19 and four have died since April. The company, which produces 5% of the nation’s pork, has been under investigation since the early spring for its workplace conditions and the large coronavirus outbreak among employees. It has continued to defend itself against “misinformation”, with President and CEO Kenneth Sullivan going as far as submitting a letter to Senators Elizabeth Warren and Cory Booker at the end of June. Smithfield has 15 business days to pay the fine or contest the citation—and the company will reportedly contest the fine, as a company spokesperson called it “wholly without merit”.
During the September 17 Episode of the 2020 Food Safety Consortium Virtual Conference Series, experts will discuss COVID-19, worker safety and managing quality in the new normal | Register NowOSHA also slapped meat packer JBS with a proposed fine of $15,615, also for a “violation of the general duty clause for failing to provide a workplace free from recognized hazards that can cause death or serious harm”. Nearly 300 workers have reportedly contracted COVID-19, and seven employees died. JBS also has 15 days to comply with or contest the fine, which a company spokesperson said is “entirely without merit” and that OSHA was trying to enforce a standard not even in existence in March.
“Contrary to the allegations in the citation, the Greeley facility is in full compliance with all recommended guidance and hazard abatements. The facility has been audited and reviewed by multiple health professionals and government experts, including the CDC, local and state health departments, third-party epidemiologists, and the Department of Labor, National Institute for Occupational Safety and Health, who twice visited the plant during the citation period, and issued favorable reports on April 20 and May 8,” according to a statement by a JBS spokesperson. “The Greeley facility has only had 14 confirmed positives in the past three and half months, representing 0.4% of our Greeley workforce, despite an ongoing community outbreak. The facility has not had a positive case in nearly seven weeks, despite more than 1,730 positives in the county and more than 33,300 positive cases in the state during the same time period.”
Meanwhile Kim Cordova, president of the union that represents JBS workers, stated that the company penalty is simply a drop in the bucket and not severe enough. “A $15,000 ‘penalty’ from OSHA is nothing to a large company like JBS. In fact, it only incentivizes the company to continue endangering its employees. The government has officially failed our members, the more than 3,000 workers at JBS Greeley, who have protected the food supply chain while our communities quarantined during the pandemic. It is immoral and unethical, but in the current Administration, unfortunately not illegal, that OSHA waited seven months to investigate the unsafe working conditions that led to this deadly outbreak. Because of this failure, JBS Greeley is the site of the most meat processing plant worker deaths in the nation due to Covid-19.”
In mid-August, FDA and OSHA released a checklist to help food companies that were going through operational changes as a result of the COVID-19 pandemic. Specifically, the “Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic” document reviews employee health and social distancing (how to deal with employee exposure and testing, the arrangement of work environments, especially considering work breaks and close operations), and food safety and HACCP plans—including suppliers and incoming ingredients—cGMPs, and other operational alterations due to COVID-19.
Today FDA held an “FDA COVID-19 Update for Food Operations Stakeholders” in collaboration with CDC and OSHA to further discuss the checklist, which targets owners, operators or agents in charge of a food operation. The purpose is to help the user assess operations during the COVID-19 pandemic, particularly operations that have restarted after a facility shutdown. Following the initial remarks, it was clear the FDA wanted to emphasize that the food safety checklist is intended to serve as a resource document, not a new guidance document or a new regulation. What was originally envisioned to be a one- to two-page checklist became a 16-page checklist that should be used in conjunction with additional information provided by FDA, CDC and OSHA, said Jenny Scott, senior advisor, office of food safety at CFSAN.
Scott reviewed the outline of the checklist, touching on employee health practices to help minimize the spread of COVID-19 (from basic handwashing practices to deadline with sick and exposed workers), employee testing and potential changes related to personnel requirements (i.e., if you are putting new people into new roles, you must consider whether more training is required), and the cGMP requirements. Among the key questions related to sanitation that Scott advised one must ask include: Are necessary cleaning, sanitizing and disinfecting supplies available? Are changes needed for cleaning, sanitizing and disinfecting procedures for certain areas or the frequency of conducting the procedures? Do the changes result in the need for updating instructions or training workers?
As the understanding of COVID-19 and how it spreads is evolving, Scott stressed that industry should frequently check FDA, CDC and OSHA websites for updates.
Michael Rogers, assistant commissioner for human and animal food operations, ORA, FDA also stressed the fact that the food safety checklist is not a new regulatory requirement, commenting that there has been “some anxiety associated” with this misperception. “This is simply an educational tool,” Rogers said. “We recognize that every firm is different, and the checklist should be information to consider…This is not an enforcement tool.” He added that the FDA’s approach during inspections will be collaborative and that the agency will not be holding firms to the specifics of the checklist. During the pandemic, the agency has been conducting mission critical inspections. FDA has also started domestic inspections in certain areas and will be preannouncing inspections as it moves forward, and it continues to assess the situation abroad to determine when foreign inspections can resume.
–UPDATE AUGUST 31, 2020 — Prima Wawona has recalled bagged, bulk and loose peaches that were distributed nationwide to retailers that include ALDI, Food Lion, Hannaford, Kroger, Target, Walmart and Wegmans. As of August 28, the CDC reported the outbreak of Salmonella infections reached 78 cases across 12 states.
In addition, the recall of Prima Wawona peaches has extended to Canada, Singapore and New Zealand. FDA states that the products may have been shipped to Australia, Canada, China, Costa Rica, Ecuador, El Salvador, Guatamala, Honduras, Mexico, Panama, the Philippines, Singapore, Taiwan and the United Arab Emirates.
Do not eat, sell or serve Wawona-brand bagged peaches from ALDI stores, says the FDA. ALDI issued a voluntary recall of two-pound clear plastic bags of peaches from Wawona Packing Company, LLC following a multistate outbreak of Salmonella Enteritidis that has been linked to the product. The peaches were sold in ALDI stores from June 1 until present, and as of August 19, the CDC reported 68 cases of Salmonella infections across nine states, with 14 hospitalizations. No deaths have been reported
“FDA’s traceback investigation is ongoing to identify the source of this outbreak and to determine if potentially contaminated product has been shipped to additional retailers,” the agency stated in an investigation update.
Learn more about food safety supply chain management & traceability during the 2020 Food Safety Consortium Virtual Conference SeriesThe FDA and CDC have been investigating a multistate outbreak ofCyclospora involving bagged salads from Fresh Express since June. Although the products were recalled and should no longer be available in retail locations, the CDC continues to report more cases. As of August 12, 2020, the CDC counted 690 people with laboratory-confirmed Cyclospora infections throughout 13 states. Thirty-seven people have been hospitalized, and no deaths have been reported.
As the FDA conducted its traceback investigation to find the source of the outbreak linked to the Fresh Express products, the agency was able to identify several farms. It analyzed water samples from two public access points along a regional water management canal (C-23) west of Port St. Lucie, Florida. Using the FDA’s validated testing method, the samples tested positive for Cyclospora cayetanensis. However, it is important to note that the Cyclospora found might not be a direct match to the pathogen found in the clinical cases.
According to FDA: “Given the emerging nature of genetic typing methodologies for this parasite, the FDA has been unable to determine if the Cyclospora detected in the canal is a genetic match to the clinical cases, therefore, there is currently not enough evidence to conclusively determine the cause of this outbreak. Nevertheless, the current state of the investigation helps advance what we know about Cyclospora and offers important clues to inform future preventive measures.”
The agency’s traceback investigation is complete, but the cause or source of the outbreak has not been determined. The investigation also revealed that carrots are no longer of interest at as part of the outbreak, but red cabbage and iceberg lettuce are still being investigated. FDA is also working with Florida and the area’s local water district to learn more about the source of Cyclospora in the canal.
Last week USDA’s FSIS issued a public health alert concerning ready-to-eat meat and poultry products that contain the onions recalled by Thomson International, Inc. (see below news brief). The products have been distributed by retail establishments that include Walmart, Kroger, HEB and Amana Meat Shop & Smokehouse. The USDA has made available the full list of products subject to the public health alert.
A multistate outbreak of Salmonella Newport has been traced back to red onions from Thomson International, Inc. a company based in Bakersfield, CA. As of July 31, 396 illnesses were reported in the United States, with 59 hospitalized across 34 states. In Canada, 120 cases have been confirmed, according to the Public Health Agency of Canada.
As a result, Thomson International is recalling all varieties of its onions (red, white, yellow and sweet) that “could have come in contact with potentially contaminated red onions”, according to an FDA alert.
The FDA, CDC, state and local agencies, as well as the Public Health Agency of Canada are investigating the outbreak. FDA recommends that consumers, restaurants and retailers refrain from eating, selling or serving any onions from Thomson International. The agency also states that any surfaces, containers or storage areas that may have come into contact with these products be cleaned and sanitized.
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.
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.
With significant clusters of COVID-19 infection among employees—16,000 cases and 86 deaths documented by the CDC through May 2020 — the food processing and distribution industry faces significant challenges in reopening their facilities and ramping up to full capacity. Technology for health and safety access governance and intelligence, along with guidelines from the CDC and OSHA, can help support food companies in the automation of certain compliance activities and a safe return-to-work strategy.
Designated part of the essential critical infrastructure by the federal government at the onset of the pandemic in the spring of 2020, the food supply chain needs active solutions to protect its workforce. But there’s more to this back-to-work transition. Workers need to feel safe and trust that new security, safety and compliance processes have their best interests in mind—transferring to an overall positive experience with their employer.
In the age of contagion, the food industry requires ways to communicate better with the workforce, identify and isolate areas of contagion and also deal with the lingering presence of potential bioterrorism, insider threat and cyber-attack. It’s a multi-faceted and complex workspace we’re reentering, one that takes coordination of technology, people and processes. Without it, food suppliers risk plant shutdowns and loss of business continuity.
Bioterrorism and insider threat remain an active part of the supply chain landscape. In fact, according to a June 2020 Wall Street Journal Pro Research Survey of cybersecurity executives at nearly 400 companies, 67% were concerned about malicious insiders. Remote workers and lax controls have exacerbated the situation and rising threats include malicious employees, accidental negligence, contractor or vendor misuse and account compromise.
The Landscape of Collaboration
The ongoing coordination between human resources (HR) and security is a collaborative effort that bolsters food defense in a COVID-19 world. Fueled by digital transformation, converged physical security and HR management solutions are wound together tightly in a coordinated and analytical approach to keep food industry employees safe and operations running smoothly.
These departments, once siloed and co-existing without direct interaction, are benefiting from software’s move to the cloud and open operating platforms, which provides increased opportunity for real-time integration of HR, security and facilities technologies. Moving to a converged approach across all departments, including HR, IT/cyber and operational technology (OT)/SCADA—can effectively secure our most critical food production and distribution resources while actively enforcing compliance and company policies, including COVID-19 mandates. In addition, physical security access governance, in a holistic manner, protects food industry workers and processes from compromised identities, systems and insider threats.
HR and physical security now have the ability to share data-insights to prevent, detect and mitigate the spread of contagions. With this convergence, organizations have the information they need to actively defend and protect the workforce, focusing on the human side of security to yield a positive experience.
Enabling a Safe and Healthy Return to Work
This time of unprecedented change has triggered a tectonic shift in the way organizations have been dealing with the health, security and safety of their workforce. Sensing a coming tsunami, HR, corporate real estate and physical security leaders are realizing that they must stop operating in silos and embrace a holistic approach. Enterprise response and recovery plans have become a major catalyst for converged security, as it has proven to be the most effective way to manage workspace access, enforce workforce security, safety and privacy.
Reopening with Technology at Your Back
Physical identity access management (PIAM) software, including visitor identity management (VIM) are convergence platforms that deliver identity and access governance, health and safety intelligence and compliance validation across the enterprise. PIAM provides a safer work environment by managing physical, logical and operational technology access for employees and visitors, actively enforcing company policies, compliance and industry regulations with built-in best practices and regulatory controls. Automated policy-driven background checks yield real-time vetting of visitors, contractors and employees while validating and identifying any policy violations. PIAM and VIM keeps facilities and workers safe, making sure the employees and visitors only have access to the areas, data and assets they need, including vital food processing areas where deliberate sabotage needs to be kept at bay.
While prevention of bioterrorism and insider threat is ongoing at food distribution, production and processing facilities there’s been a notable shift during the pandemic that focuses on the health and safety of workers. Security is no longer simply about keeping the bad guys out; it’s about safety and protecting workers from unsafe behavior.
Workforce health and safety access governance software solutions help organizations open safely in a frictionless, controlled and secure way by automating and enforcing COVID-19 related policies and procedures. Automated batch email/text notifications with self-service links send requests to the remote workforce for self-attestation and self-reporting offsite and enable access by the worker to the facility based on health, travel and other company policies.
Here’s how it works: An employee completes the self-reporting health and travel questionnaire through a mobile app, which triggers automated workflows based on those answers. These health questionnaires collect data and document employee activity during lockdown, including infection, symptoms or exposure. The employee’s self-attestation request comes to the manager for action, and based on answers the worker is considered high risk and per policy their access to the facility is revoked for 14 days while they are in quarantine. A similar self-attestation and workflow then applies to reinstatement for the employee. This reporting and workflow can be configured specifically to the facility. Enterprises can further customize their visitor identity management to provide clear communication of current policies during the outbreak, reinforcing WHO best practices.
Focus on Health and Safety
Health and safety access governance and intelligence provides prescreening support of workforce site entry with automated policy enforcements. Pre-registered and onsite visitors/contractors check-in/check-out with prescreening, watch list and other checks prior to access. In the production or distribution facility, health and safety analytics track confirmed or potentially exposed COVID-19 workers, identify exposed areas for lockdown and/or sanitization, social distancing violation, location heat map and other actionable health & safety analytics.
PIAM also allows you to automate your communications and deliver clear expectations and procedures to your workforce, visitors and contractors pre-visit and onsite—adding to a seamless experience.
Security convergence delivers a comprehensive, holistic solution across the entire food value chain, from sourcing to production to retail distribution. Human resources and physical security have teamed up—yielding real-time data that can prevent, detect and mitigate the spread of contagions. With this convergence comes greater situational awareness that defends and protects the workforce, with a strong focus on safety and building trust between worker and employer.
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