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The FDA is implementing a major reorganization plan called “Simple Reform” on October 1, 2026

By Food Safety Tech Staff, Rick Biros
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August 10 update to this article: Apparently, there has been some confusion when the Simple Reform info went out because it is not affecting food, according to Dr. Stephen Ostroff, in a follow up email. Also, Steven Mandernach, J.D. Executive Director of Association of Food and Drug Officials (AFDO) told FST, he spoke with his food program contacts at the FDA last week, and they confirmed that the Human Foods Program is not affected by Simple Reform.

Originally reported: The Trump administration approved FDA’s reorganization proposal, according to an internal agency announcement. In the announcement, Melanie Keller, the FDA’s deputy commissioner for operations and chief operating officer, said the reorganization proposal known as “Simple Reform” will go into effect on Oct. 1 of this year.

The FDA’s “Simple Reform” reorganization primarily changes internal agency administration rather than regulatory standards, meaning current compliance rules and quality system requirements remain legally unchanged for industry facilities. However, shifting to a generalist inspectorate heavily reshapes how inspections will play out in practice.

Under the revised structure, individual centers like the Human Foods Program (HFP) will no longer conduct their own administrative affairs like human resources, finance and information technology services. Instead, the agency will operate under a “shared service” model in which the FDA Office of Operations controls those functions across the agency.

The agency will end deep technical specialization for field inspectors, merging food & beverage, medical devices and clinical research inspectorates into a mixed pool of generalists. Investigators will handle inspections across multiple industries instead of focusing exclusively on one narrow technical product field.

The food and beverage industry should expect a shift in audit dynamics, meaning audits will likely focus less on highly specific, niche technical processes and more on foundational, broad-spectrum quality systems.

In 2017, FDA moved to place inspectors within specific programs of expertise, rather than requiring them to work across multiple programs. Simple Reform will reverse that.

Food Safety Tech reached out to Dr. Stephen Ostroff, who was the Deputy Commissioner for Foods and Veterinary Medicine at FDA a position he assumed in May 2016.

Rick Biros: “Steve, I’m curious to learn your opinion on Simple Reform and the impact you think it will have on food safety. I’ve reached out to Mike and Frank as well.”

Stephen Ostroff, FDA
FDA’s Stephen Ostroff, M.D. answers audience questions at the 2017 Food Safety Consortium Conference

Steve Ostroff: “I was  the Acting Commissioner of FDA when Program Alignment was finalized after several years of work.  I recall celebrating in Chicago (after your conference) at the district office downtown.  Program alignment was an effort to better vertically and horizontally align inspection activities – vertically within the inspectorate and horizontally between the Office of Regulatory Affairs inspectors and the headquarters programs.  It recognized that having generalist inspectors was inefficient and failed to take into account how technically sophisticated FDA regulated products had become (and were rapidly becoming).  It wasn’t possible for an inspector to be technically proficient in medical devices, gene therapies, regenerative medicine, infant formula, synthetic foods, etc. etc.  It also wasn’t helpful to have an inspector principally working on foods be supervised by someone with expertise in medical devices.  It was an effort that recognized the need for specialization and it was right then and it continues to be right.

The idea that inspectors would return to being generalists is a step in the wrong direction.  The significant loss of inspectors since early 2025 may in part explain why this is being proposed.  But this won’t solve that problem and won’t address the significant backlog of inspections in the food program, especially international inspections.  It’s more likely to exacerbate it.
As for centralizing administrative functions like HR, finance and IT, this is like a pendulum that swings back and forth.  It’s been tried over the years and there’s little evidence that it works or helps.  In addition, given the resource imbalances at FDA between the medical products programs and the food program, it’s a recipe for the interests of the food program and needs of the food program to end up at the back of the line.  As is so often the case, unfortunately. “
Frank Yiannas, who followed Dr. Ostroff as the next Deputy Commissioner for Food at FDA added “Don’t think it will achieve better results.”

“Simple Reform” will go into effect on Oct. 1 of this year. Dr. Donald A. Prater, Acting Deputy Commissioner for Food, U.S. Food and Drug Administration (FDA) will be presenting at the Food Safety Consortium Conference. October 21-23, 2026 in Washington DC. More info at FoodSafetyConsortium.org.

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FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment

By Food Safety Tech Staff
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Ensuring Food Safety from the farm to the table is crucial. How inspections and audits play a key role

By Don Abbott
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Food safety is an issue that is critical to millions of people’s health every year worldwide. Maintaining a high standard of hygiene is essential in preventing contamination and ensuring all people receive the safest quality food products every time. Inspections and audits are the key components to the industry’s effort to maintain these standards. These processes help identify potential risks and hazards, ensuring companies are compliant with regulatory requirements, and to ultimately protect all people’s health.

Audits and Inspections both verify the facility’s compliance with regulatory and procedural compliance, but in different ways. According to ISO definition, an audit is “systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.” An inspection is the “determination of conformity to specific requirements,” such as FDA or USDA regulations.

The Importance of Inspections and Audits

Inspections and audits are vital in the food industry for many reasons:

  1. Preventing Foodborne Illnesses: Regular inspections and audits help the industry identify and mitigate risks that have the potential to lead to foodborne illnesses. This is a very crucial task in preventing outbreaks that can cause severe health issues and even fatalities.
  2. Regulatory Compliance: The food industry is subject to stringent regulations set by governmental and international bodies. Inspections and audits help to ensure companies are complying with these regulations consistently, avoiding any legal penalties and maintaining consumer trust.
  3. Quality Assurance: Inspections and audits help ensure food products meet quality standards also, which is very important and essential for companies maintaining brand reputation and customer satisfaction.
  4. Risk Management: Identifying personal hazards and implementing corrective actions during inspections and audits helps the companies manage and reduce risks associated with food production and distribution.

Inspection Process

Food inspections and audits involve a thorough examination of facilities, processes, and products. The process typically includes the following steps:

  1. Preparation: Inspectors will review relevant documents, any previous inspection reports, SOPs, and compliance records, to better understand the facility’s history and operations.
  2. On-site Inspections: Inspectors will visit the facility in order to observe operations, interview staff, and inspect all equipment and outside premises.
  3. Sampling and Testing: Samples of food products may be collected for laboratory testing to detect contaminants or verify compliance with safety and quality standards.
  4. Documentation and Reporting: Inspectors will document their findings and provide a detailed report outlining any observations of non-conformances.
  5. Follow-up: A follow-up inspection may be conducted to ensure all non-conformances have been closed and corrective actions have been implemented and the facility is compliant with all regulations.

Audit Process

Audits are systematic and independent examinations of records, processes, and systems to ensure compliance with specific standards. There are several types of audits in the food industry, including internal audits, supplier audits, and third-party audits. The audit process generally involves the following steps:

  1. Planning: The audit scope, objectives, and criteria are defined. An audit plan is developed, detailing the audit schedule and then areas to be examined.
  2. Execution: Auditors will review documents, conduct interviews, and observe operations to gather evidence. They assess compliance with regulatory requirements, industry standards, and company policies.
  3. Analysis: Auditors analyze the evidence collected to identify areas of non-compliance, potential risks, and opportunities for improvement.
  4. Reporting: A comprehensive audit report is prepared, highlighting findings, conclusions, and recommendations for corrective actions.
  5. Follow-up: Auditors may conduct follow-up audits to verify all corrective actions have been implemented and compliance has been achieved.

Food Recalls

Food recalls are an integral part of the food safety system, initiated when a product is found to be contaminated or mislabeled. They are often the result of inspections and audits that identify serious issues. Here are a few notable statistics.

  • There were 547 Food and Drug Administration (FDA) food recalls in 2023, a five-year high for the industry and 19.6% more events than were recorded in 2022. FDA recalls are on track in 2024 to be consistent with 2023. U.S. Department of Agriculture (USDA) recalls also increased, rising 31% from 2022. The volume of units recalled also increased a more notable 132.8% from 2022 to 2023.
  • In 2023, 313 food products (224 from FDA, 89 from USDA) were recalled, over 1,100 people were sickened and 6 people died from foodborne illness recalls (based on data collected). The two largest recalls, lead-tainted applesauce sickened 519 children in 44 states, and Salmonella contaminated cantaloupe sickened over 400 people. CDC estimates 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States.
  • 2% of all FDA recalls stemmed from undeclared allergens, a 27% increase from 2022. One reason for the increase in allergen recalls is as of Jan. 1, 2023, manufacturers had to disclose sesame in their foods. The most common undeclared allergens — wheat, shellfish, eggs, fish, peanuts, milk, tree nuts and soybeans — account for 90% of all food allergic reactions. Listeria was listed as second and Salmonella third for the most recalls.
  • Unsurprisingly, as the nation’s largest producer of food, California was found to be responsible for the largest share of all recalls. Over 16.3% of recalls originate from California products. Followed by New York at 8.1% and Texas at 6.5%. California customers are also most frequently affected by recalls. 39.8% of all recalls nationally impact residents in California, followed by New York at 36.4% and Pennsylvania at 35.8%.

The Role of Technology in Inspections and Audits

Advancements in technology have significantly enhanced the effectiveness of inspections and audits in the food industry. Some key innovations include:

  1. Data Analytics: Big data analytics enable companies to identify trends and potential risks by analyzing large volumes of data from various source, such as inspection reports, consumer complaints, and laboratory results.
  2. Blockchain: Blockchain technology provides a transparent and immutable record of the entire food supply chain, making it easier to trace the origin of products and detect potential issues quickly.
  3. IoT Devices: Internet of Things (IoT) devices, such as sensors and RFID tags, provide real-time monitoring of conditions like temperature and humidity, ensuring that products are stored and transported under optimal conditions.
  4. Mobile Inspection Tools: Mobile applications and digital platforms streamline the inspection process by allowing inspectors to record findings, take photos, and generate reports on-site, reducing paperwork and improving efficiency.

Inspections and audits are indispensable components of the food industry’s efforts to ensure safety, quality, and compliance. They play a crucial role in preventing foodborne illnesses, managing risks, and maintaining consumer trust. As the technology continues to advance with properly trained and calibrated auditors, the effectiveness and efficiency of inspections and audits will only improve, further safeguarding the food supply chain from the farm to the table.

By understanding the crucial role inspections and audits play, stakeholders in the food industry can better prepare to meet the high standards necessary to ensure that food products are safe for consumption. The continued evolution of these processes, bolstered by technological advancements, promises a safer future for consumers worldwide.

Reference:

  1. Trace One analysis of 2020–2024 FDA and USDA data
Paul Bradley
FST Soapbox

The Delicate Dance of Global Food Safety

By Paul Bradley
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Paul Bradley

A universal truth in bustling cities and rural villages alike is that people want to know the food they are eating is safe. Brands tasked with ensuring food safety walk a line between meeting regulatory requirements and balancing resource constraints. It’s a delicate dance in both developing and established economies.

At the federal level, we typically see programs designed to ensure food safety relegated to the back burner.  In the U.S., the FDA’s food program, a linchpin of food safety, has experienced its own challenges according to revelations from Stephen Ostroff. The two-term acting commissioner of the FDA has publicly revealed the internal struggles across various regulatory bodies both within the FDA and the U.S. regulatory system. Across the pond in the UK, efforts to modernize food safety and hygiene inspections have faced their own setbacks, including a lack of inspectors and poor cross-border coordination.

For nations at every stage of development, the road to food safety regulation is long and winding. Charting the way requires innovative solutions and collaborative effort on a global scale.

Challenges in Developing Countries

In developing countries, insufficient regulatory frameworks, a lack of enforcement, and the absence of modern technology and facilities for proper food handling and processing are major hurdles to ensuring broad food safety. We have seen time and again that efforts to improve food handling practices often result in short-lived change and challenges when scaling.

Beyond resource constraints, the prevalence of street vendors and local markets in the “informal sector,” which serve a significant portion of the population, typically lack oversight. A 2020 study published in the National Library of Medicine estimated that 2.5 billion people globally rely on street food for at least one meal daily, highlighting the importance of solving food safety concerns in this sector.

Food contamination also poses a serious threat. Microbiological pathogens including Salmonella, E. coli, Listeria, and chemical contaminants, can render food and water unsafe. According to a recent UN World Water Development Report, around 2 billion people globally don’t have access to clean and safe drinking water, and approximately 3.6 billion people — 46% of the world’s population — lack adequate sanitation services.

The FDA’s Funding Dilemma

While food safety in the U.S. isn’t as dire as developing countries, we face a different set of concerns. The FDA’s historically underfunded food program has lagged due to staffing shortages, leadership issues and limited resources. A recent 10% increase in funding is a step in the right direction, but critics argue it’s still not enough. Many believe the agency prioritizes drug and medicine oversight and is biased towards appointing leaders with medical backgrounds rather than food industry knowledge.

Beyond the lack of funding and internal infrastructure, there is a broader push to restructure the FDA altogether. The 100+ year old agency created by the passage of the 1906 Pure Food and Drugs Act, is beginning to show its age. Today, with limited staff and resources, the FDA struggles to inspect foreign food shipments and physically examines less than 1% of imported products. With consumer palettes increasingly favoring global delicacies, this nominal inspection rate underscores the need for increased funding and a more innovative approach to FDA strategies.

UK’s Tightrope Walk on Food Safety

Similarly, in the UK, where the Food Standards Agency (FSA) governs food safety, budgetary constraints and other industry concerns are causing setbacks as it attempts to modernize inspections. The FSA has expressed concern that local authorities do not have the resources to deliver food controls, with new data revealing that they are a long way off from meeting the required frequencies of interventions at lower-risk establishments. As a result, some outlets in England, Wales, and Northern Ireland have not been checked for years. Additionally, UK’s exit from the European Union (Brexit), adds another layer of complexity, with potential disruptions to regulatory frameworks and the need for new trade agreements.

A Cautiously Optimistic Outlook on Global Food Safety

The global food safety landscape is at a crossroads and headed for extinction if changes do not take place within the next decade. Initiatives such as capacity-building programs, training workshops, and public-private partnerships empower individuals and organizations with the knowledge and skills necessary to implement effective food safety practices, while the global exchange of digital food safety data increasingly levels the information playing field for brands and regulatory bodies alike.

Achieving global food safety requires a multi-stakeholder approach that recognizes the unique challenges faced by different nations and leverages the strengths of various stakeholders. By focusing on prevention, capacity building, collaboration, and innovation, we can work towards a future where everyone has access to safe and nutritious food. This journey will require sustained commitment from governments, international organizations, the private sector, and individuals to ensure a healthy and sustainable future for all. For those of us in the business of helping to ensure food safety by creating a more transparent global supply network and making regulatory compliance easier to navigate, we are cautiously optimistic in the future and believe in the industry’s ability to rise above the challenge.

Rick Biros
Biros' Blog

The Rising FSQA Phoenix

By Rick Biros
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Rick Biros

Last month, the Food Safety Tech team wrapped up a very successful Food Safety Consortium Conference. While I could name drop many of the who’s who of food safety who presented this year, Erik Mettler, Assistant Commissioner for Partnerships and Policy in the FDA’s Office of Regulatory Affairs, gave a great keynote address in tandem with Sandra Eskin, Deputy Undersecretary for Food Safety at USDA FSIS. Erik stayed for the full conference and participated in two additional panel discussions, one on Succession Planning and the second on Recalls. Sandy stayed for two days and made herself accessible to the delegates.

As the conference director I’m also the emcee. I introduce the speakers and panelists, but I also have the opportunity to be a participant and observe the interplay between delegates. What I observed at the Consortium was great networking, conversations and mentoring but what really stood out was a real energy among the delegates, something I haven’t seen at any food safety conference in the last few years. I believe that energy is an indicator that FSQA (food safety and quality assurance) is coming back from the devastation and impact of the Covid-19 pandemic.

For example, on the topic of FSQA auditing and inspections, Covid significantly reduced the amount and type of internal and supplier audits as well as FDA inspections. Many auditors who were independent contractors just quit. They moved on because there was no work. This left a huge void in trained and experienced auditors.

Our session on Succession Planning for Inspectors and Auditors included panelists from government, academia, industry and industry associations. They discussed the increase in inspections and audits coming in 2024 and thus, the real need to fill the void in inspectors and auditors left from the pandemic, as well as the need to train and nurture those folks.

Another theme at the Consortium was the continued evolution of Food Safety Culture. Delegates were looking for ways to take Food Safety Culture to the next level and apply metrics to it. We did a post conference survey, and the feedback we received supports this. Here are some of the direct responses:

Q: What were your top takeaways from the Food Safety Consortium?

  • Transparency from regulators and ways to foster growth and culture.
  • Food Safety Culture is in the forefront, as evidenced by the numerous panels. I attended nearly every one pertaining to this subject. It is a difficult subject because it is subjective and difficult to measure and quantify.
  • Food Safety Culture is ever evolving and becoming a more important factor every year. We need a new system but are unwilling to scrap or majorly overhaul the current one … FSMA was supposed to drastically reduce foodborne illness incidents. It doesn’t seem to be working, and we are nearing the time for FSMA 2.0. While it doesn’t appear that we are getting better at reducing the number of incidents, we are getting better at detecting them.

Q: What Topics should we plan for next year’s Food Safety Consortium?

  • Updates from the FDA and USDA on current projects
  • How to demonstrate Food Safety Culture. How to build a program and maintain momentum was discussed this year. But how do we show results to auditors? We need guidance and expertise on proving a solid FSC to auditors.

My takeaway from this year’s Food Safety Consortium is that the FSQA community is on the cusp of a resurgence in activity, training and investments—like a Phoenix rising from the ashes of Covid. But even before the pandemic, there was an overall sense of FSMA and GFSI fatigue. I am seeing a collective increase in FSQA activity that has not been present in many years, and that’s a good thing!

In 2024, we will see accelerated digital transformation. Data analytics will play a greater role in FSQA strategies. Getting an entire industry and supply chain ready for FSMA 204 in two years will be a huge undertaking. Also, Food Safety Culture will evolve to provide metrics and data for accountability.

Food Safety Tech continues to publish original weekly articles on these emerging trends. We are introducing a new FSQA Auditor Training program in Q1, and next year’s Food Safety Consortium conference will be held October 20-22, 2024, in Washington, DC, continuing the conversations, debates and discussions.

You can be part of this new wave of FSQA energy by contributing an article to Food Safety Tech or submitting an abstract for the 2024 Food Safety Consortium conference.

This new wave of energy has inspired me. It’s been a while since I last wrote this column, way too long. And FSMA 2.0, that will be the subject of a future column. Also, I’ll share my thoughts on the new food safety agency, our new podcast partners from Don’t Eat Poop and many other topics. Until next time…

All the best!

Rick Biros, Founder, Publisher, Conference Director

 

 

FDA Commissioner Robert M. Califf, M.D.

FDA Updates Proposal for Unified Human Foods Program With New Model for ORA

By Food Safety Tech Staff
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FDA Commissioner Robert M. Califf, M.D.

On June 26, the FDA shared an update on its proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). The changes are based on findings and recommendations of a working group made up of agency officials with expertise in different functional and operational areas that has been working over the past several months to identify additional opportunities to bolster operations within the new HFP and ORA.

Based on recommendations from the working group and from the external evaluation conducted by the Reagan-Udall Foundation, the FDA is proposing the following additional changes:

  • Establishing ORA’s core mission as conducting investigations, inspections and imports for all FDA-regulated products, with assignments planned in partnership with the HFP and other product programs or Centers. The new Deputy Commissioner for Human Foods will have oversight of all budget and resource allocations for the entire HFP, including ORA resources.
  • Merging compliance functions currently managed within ORA into the HFP and the product Centers’ existing compliance functions to streamline operations and expedite decision-making.
  • Realigning the eight Human and Animal Food laboratories that are currently managed by ORA into the HFP. These eight labs will team up with the four labs in the FDA’s current Center for Food Safety and Applied Nutrition (CFSAN) to form a unified food laboratory enterprise under the HFP. The labs will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods, who will work closely with the Chief Scientist and the Center for Veterinary Medicine (CVM) director to coordinate on research priorities. These labs will remain open and in the same geographic location under the proposal.
  • Transitioning certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA. This includes the Office of Emergency Management, which activates Incident Management Groups with augmented staffing from relevant Centers and Offices to monitor and manage coordinated responses to emergency situations, such as emergencies involving regulated products like recalls, hurricanes, fires, floods, etc.
  • As previously shared, unifying state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP. This office will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods who will closely collaborate with the CVM director to advance a truly integrated food safety system.
  • Reviewing support functions across ORA and proposing realignment of certain resources and personnel to support these changes. This includes staff and resources in ORA’s Office of Regulatory Management Operations, Office of Information Systems Management, Office of Training, and Office of Communications and Project Management.
  • Prioritizing recruitment, retention and training opportunities for field-based employees with the availability of Title 21 hiring authority to support the agency’s ongoing efforts to increase its inspectional activities domestically and internationally.

“With a human food landscape that is rapidly evolving as consumer preferences, products, and manufacturing processes grow increasingly complex and public health needs increase, the FDA must build a stronger Human Foods Program and Office of Regulatory Affairs. Earlier this year the FDA announced steps to modernize and streamline our food program, including field operations, to address these mounting challenges,” said FDA Commissioner Robert M. Califf, M.D. “Listening closely to feedback provided by employees and stakeholders, our thinking has significantly broadened. We know that in front of us is a once-in-a-generation opportunity to unify our field work with the priorities of program offices and Centers. This is why I’m proposing a number of additional changes to ORA, including moving several of the office’s laboratories and merging its current compliance functions into those of the new HFP and other agency product Centers. These proposed changes are designed to help ensure the most strategic use of resources to meet the demands of our increasingly complex public health mission.”

The agency also provided high-level organization charts to reflect the changes that are being proposed as part of the unified HFP and new ORA model, and announced that it is considering a renaming effort for ORA to more appropriately align its title to the structure and functional duties of the agency’s field operations.

“I believe these proposed changes will result in a new structure that is more nimble, better equipped to prevent and respond to emergencies, like recalls, and enhance the agency’s ability to align inspection resources with our Center and program priorities while also supporting our employees and the public we serve,” said Califf. “We will continue to evaluate and make adjustments as we work closely with experts throughout the agency to revamp and enhance our field operations.”

The FDA noted that it recently began a recruitment effort to fill the position of Associate Commissioner for Regulatory Affairs who will lead ORA through the proposed changes and assist the organizational evolution as envisioned in this proposal if approved. The FDA is also in the final stages of the recruitment process for the Deputy Commissioner for Human Foods and stated that it remains on target to finalize its reorganization proposal, for both ORA and the unified HFP, this fall.

Image: FDA Commissioner Robert M. Califf, M.D.

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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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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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.