Tag Archives: inspections

FDA

FDA Seeks $57 Million in Investments in Food Safety Modernization and Funding to Reduce Chemicals in Food

By Food Safety Tech Staff
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FDA

Today the FDA announced its budget request as part of the President’s 2023 fiscal year budget. Within the food sector, the agency is asking for $43 million for food safety modernization (including animal food safety) oversight—which includes efforts in continued implementation of the New Era of Smarter Food Safety initiative. The funding will also go towards improving preventative food safety practices, data sharing, predictive analytics and traceability, which will help the agency respond to outbreaks and recalls faster. “In partnership with states, the FDA will expand efforts to modernize, harmonize and transform the U.S. animal food inspection system to become more comprehensive and prevention oriented,” the FDA stated in an email release.

The FDA also requested $14 million in funding to reduce exposure to harmful chemicals and toxins in food. Last year the agency came under fire following a report released by Congress that stated there was an alarming amount of toxic heavy metals found in baby food. In response, the FDA devised a “Closer to Zero” action plan with a goal of reducing the presence of dangerous metals in foods commonly consumed by babies and young children. “Additional funding and legislative proposals will focus specifically on better protecting mothers, infants and young children through contamination limits in food, product testing requirements, notification of anticipated significant interruptions in the supply of infant formula or essential medical foods, as well as modernization of dietary supplement regulation,” the FDA stated.

Under the FDA’s funding requests that serve its core operations, the agency asked for $68 million for data modernization and enhanced technologies, which includes improving infrastructure aligned to the food programs; and $24 million to optimize inspections, including increasing support for recruiting and training new FDA investigators.

The FY budget covers October 1, 2022 through September 30, 2023.

FDA

FDA Ready to Start Domestic Surveillance Inspections

By Food Safety Tech Staff
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FDA

Last week the FDA announced that it would resume conducting domestic surveillance inspections on February 7—affecting all commodities. The agency will continue with mission-critical domestic and foreign inspections, and leverage remote assessments when necessary. FDA will also conduct previously planned foreign surveillance inspections that have received country clearance and fall within the CDC’s Level 1 or Level 2 COVID travel recommendation.

“Throughout all these activities, the agency remains committed to the health and safety of its investigators and will provide the protection needed to safely inspect facilities and conduct investigations at the ports and in agency laboratories.” – FDA

FDA’s plans to start foreign prioritized inspections in April. It will also continue remote FSVP activities for human and animal foods. However, state inspections under the FDA contract have the authority to determine whether to make inspection decisions as per local information.

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

Mitzi Baum, Stop Foodborne Illness
Food Safety Culture Club

Our Petition to USDA: The Time for Change Is Now

By Mitzi Baum
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Mitzi Baum, Stop Foodborne Illness

On January 25, 2021 Stop Foodborne Illness (STOP), in collaboration with Center for Science in the Public Interest, Consumer Reports, Consumer Federation of America and five STOP constituent advocates filed a petition with USDA Food Safety Inspection Service (FSIS) to reform and modernize poultry inspections. The goal of these reforms is to reduce the incidence of Salmonella and Campylobacter contamination in raw poultry thus drastically decreasing foodborne illnesses due to these pathogens.

According to the CDC, in 2019, these two pathogens combined were responsible for more than 70% of foodborne illnesses in the United States. As Mike Taylor, former FDA Deputy Commissioner for Foods and Veterinary Medicine, shares in his
Op-Ed, the time for change is now as the current regulatory framework is inadequate and has not delivered the desired results of reducing Salmonella and Campylobacter outbreaks.

Today, the USDA’s mark of inspection is stamped on poultry, although birds may exceed the performance standards; there are no clear consequences for establishments that do not meet the current guidelines. Without science-based standards or penalties for non-compliance, the burden of this problem falls upon consumers.

At STOP, we share the voices of consumers whose lives have been altered due to preventable problems such as this. Our constituent advocates share their journeys through severe foodborne illness to share the WHY of food safety. Real people, real lives are impacted when we do not demand action. STOP board member, Amanda Craten, shares her son Noah’s story:

“My toddler suddenly came down with a fever and diarrhea, but it wasn’t until weeks later that I learned that his symptoms, which nearly killed him, were caused by a multi-drug resistant strain of Salmonella.

After being admitted to the hospital, his doctors found abscesses in the front of his brain caused by infection and they were creating pressure on his brain. He underwent surgery and weeks of antibiotic treatments.

My 18-month son was seriously injured and permanently disabled as a result of Salmonella-contaminated chicken.” – Amanda Craten.

Unfortunately, Noah’s story is not rare, which is why Amanda supports this petition for change and has provided a powerful video about Noah’s foodborne disease journey and his life now.

Because there are too many stories like Noah’s, STOP and its partner consumer advocacy organizations want to work with FSIS and industry to:

  1. Develop real benchmarks that focus on reduction of known, harmful pathogens in poultry
  2. Modernize standards to reflect current science
  3. Implement on-farm control measures
  4. Re-envision the standards to focus on the risk to public health

As a new administration begins, capitalizing on this opportunity to modernize poultry inspection that can benefit consumers and the food industry makes sense. STOP and its partners are hopeful that leadership at USDA/FSIS will take this opportunity to create consequential and relevant change. Ultimately, this transformation will reduce the incidence of foodborne illness due to contamination of poultry and increase consumer confidence in the USDA’s mark of inspection. Please comment on this petition.

Have you been impacted by foodborne illness? Tell STOP Foodborne Illness about it.

OSHA

OSHA Fines Smithfield Foods, JBS for Failing to Protect Workers from COVID-19

By Food Safety Tech Staff
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OSHA

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.”

Summer of 2020: Hot Topics Include FDA Inspections, Records Retention, and New Technology Era

By Food Safety Tech Staff
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10

Is Food-Grade always Food-Safe?

9

Important Restaurant Food Storage Safety Tips You Need to Know

8

How a History of Slow Technology Adoption Across Food Supply Chains Nearly Broke Us

7

FDA Unveils Blueprint for New Era of Smarter Food Safety

6

FDA, CDC Investigating Multistate Cyclospora Outbreak Involving Bagged Salads

5

COVID-19 Leads Food Companies and Meat Processors to Explore AI and Robotics, Emphasize Sanitation, and Work from Home

4

FDA Announces Inspections Will Resume…Sort Of

3

Sustainability Strategies for the Food Industry

2

Top Three Visibility Challenges in Today’s Food Supply Chain

1

The COVID-19 Record Retention Conundrum

FDA

FDA on COVID-19 Food Safety Checklist: This is Not a Regulatory Requirement or Enforcement Tool

By Maria Fontanazza
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FDA

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.

(Noteworthy link from CDC: Testing Strategy for Coronavirus (COVID‐19) in High‐Density Critical Infrastructure Workplaces after a COVID‐19 Case is Identified)

Update on FDA Inspections

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.

Coronavirus, COVID-19

China Stops Poultry Imports From Tyson Foods Due to COVID-19 Concerns, Clamping Down on Inspections

By Food Safety Tech Staff
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Coronavirus, COVID-19

On Sunday China’s General Administration of Customs announced that it would be suspending imported shipments of poultry from a Tyson Foods plant based in Springdale, Arkansas. The suspension is reportedly due to an outbreak of coronavirus cases at the facility.

On Friday Tyson Foods announced the results of COVID-19 testing conducted at its facilities in northwestern Arkansas (Benton and Washington counties): 3,748 employees were tested; 481 tested positive, and 95% were asymptomatic.

“The results across our Northwest Arkansas facilities, and the country more broadly, reflect how much is still unknown about this virus, which is why Tyson is committed to providing information to our local health officials and enhanced education to our team members,” said Tom Brower, senior vice president of health and safety for Tyson Foods stated in a company press release. “Through our inclusive approach to large-scale testing, we are finding that a very high level of team members who test positive do not show symptoms. Identifying asymptomatic cases helps the community, since other testing is often limited to people who feel unwell.”

Meanwhile, it has also been reported that officials in China want the inspection process of overseas shipments ramped up, as they suspect that COVID-19 could be present on imported frozen food products.

Over the weekend PepsiCo’s Beijing operations were suspended following confirmed coronavirus cases at its chips production facility.

Last week new cases of the coronavirus were reported in Beijing, leading to concerns of a resurgence of the virus. Some new cases have been linked to the Xinfadi Market, a wholesale food market.

Shane Morris, RiskLimiter, Gleason Technology
Retail Food Safety Forum

Modern Technology’s Approach to Food Safety

By Shane Morris
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Shane Morris, RiskLimiter, Gleason Technology

Many food retailers are dependent on outdated methods of recording product food temperature that include pen, paper and trust given to employees to remember to complete inspections. Unfortunately, this style of inspection completion can be an outlet for foodborne Illness outbreaks. As technologies advance to offer real-time reporting, managing such vital inspections and reports has never been so simple while drastically reducing risk and increasing consumer safety.

Food service management should be asking the following questions on a daily basis:

  • What food items passed & failed the cooling/cooking process?
  • Why did these items fail and what is the monetary value of product loss?
  • Have safety & operational checklist logs been completed on time?
  • What corrective actions were issued?
  • Have temperature-controlled cases failed within the last 24 hours?

With recent breakthroughs in food safety technology, the answers to the above questions can be found in your email inbox, online dashboard or mobile application. There are technologies available that give food service providers the ability to efficiently track and manage their food safety efforts by digitizing any type of food safety, quality assurance and sanitation inspections. One such technology uses a dual infrared/probe Bluetooth thermometer and real-time temperature sensors to help complete food safety temperature checks as well as bringing automation to cooling, cooking, and “time as temp” logs. This kind of technology can be integrated into food safety and risk management tools such as sensor monitoring or location-driven inspection technology.

This proprietary Bluetooth thermometer uses a dual infrared/probe and real-time temperature sensors. Image courtesy of RiskLimiter.

Sufficient inspection software is not just a format for checklist completion. Software developed for the food service industry is behavioral based, meaning the software will guide inspectors to their next question and corrective action; or it automates the processes all together. This includes reminding inspectors when inspections are due in addition to providing snap shots to management on the status of said inspections with the ability to easily pull all data from the cloud.

Automated Logs for Cooking, Cooling and ‘Time as Temp’

Before taking a closer look at how new technology is shaping cooling logs, cooking logs, and time as a public health control; the following are a few terms to remember:

  • Cooling & Cooking Logs: Recording of food product temperatures during cooking & cooling cycles that meet both time and temperature constraints outlined by the FDA.
  • Time as a Public Health Control: Food product whose holding compliance is measured not by temperature but by time spent in the range of 41° F – 135° F after either being cooled below 41° F or heated above 135° F, as outlined by the FDA.
  • Strategy: What is being done with the food product? Is it being cooked, cooled or held for Time as a Public Health Control?
  • Phase: Time and/or temperature constraints set within the strategy. For example, cooling product from 135° F to 70° F within two hours or cooking to 165° F before being served.

As one of the most groundbreaking forms of food safety inspections, automated cooling and cooking logs create the ability to customize strategies for such processes. Cooling and cooking logs are an important aspect of food safety for their ability to complete the product lifecycle that can often times be overlooked. Such logs also help to ensure food product is cooked to proper temperatures before it is served to customers. Cooling log strategies look for product to be cooled from 135° F to 70° F within two hours and from 70° F to 41° F within four hours. Cooking logs are built in similar fashion but may vary on the type of product.

Proactive technology allows food service personnel to automate the cooling and cooking process with sensors that record and save product temperatures during cooking and cooling strategies. Once temperature thresholds are succeeded or anticipated to be missed, customized alerts can notify employees that the food is either ready to be served or that action is needed to avoid product loss.

For example, cooling a batch of rotisserie chickens would typically require an employee to manually check the product temperature every 30 minutes to ensure the rotisserie chickens are being cooled properly. With new technology, this same employee can insert a food-grade sensor probe into one or more of the chickens and walk away. The employee can reference a mobile application and real-time push notifications to ensure the chickens are cooling from 135° F to 70° F within two hours and from 70° F to 41° F within four hours. If the software’s algorithms predict that the rotisserie chickens will not meet the conditions set in the phase, proactive push notifications will be sent to the employee for specific action to ensure proper cooling, which avoids product loss and consumer claims related to foodborne illness. Using this method also allows for overnight cooling logs in addition to saving labor hours, all while eliminating paper.

As demand for increased food safety practices continues to climb, so will the capabilities of behavioral based inspection technology. Equipped with industry leading software engineers along with dual purpose customer support and onboarding services, this space will expand on its software and hardware capabilities to replace all outdated methods of inspection processes.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Some Very Fishy Fish

By Susanne Kuehne
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Susanne Kuehne, Decernis
Tuna, food fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database.
Image credit: Susanne Kuehne.

The coronavirus lockdown has halted fishing operations in most Indian harbors, and now stale fish and shellfish is finding its way to the consumer. In India, 50 tons of stale and spoiled tuna fish and prawns, no longer fit for human consumption, have been seized and destroyed after inspections by the Food Safety Department. These violations can carry fines and jail sentences.

Resource

  1. The New Indian Express. (April 11, 2020). “Stale tuna fish, prawns flood markets”.