Tag Archives: USDA FSIS

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FSIS Announces Stronger Measures to Protect the Public from Listeria monocytogenes

By Food Safety Tech Staff
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The changes FSIS is announcing fall into three categories: enhancing its science-based approach to mitigate foodborne pathogens, with a key focus on Listeria monocytogenes; improving training and tools for its inspection workforce; and evolving its oversight of regulated facilities, with an emphasis on data review and state inspection agreements. FSIS will initiate the following changes in the next 30 days:

Enhancing FSIS’ Regulatory and Sampling Approach to Listeria 

  • Effective January 2025, FSIS will add broader Listeria species testing to all samples of ready-to-eat product, environmental and food contact surfaces. FSIS laboratories currently test these samples for Listeria monocytogenes, which is the specific type of Listeria species that causes illness. However, adding additional species testing to the agency’s regulatory framework will help provide more information about the effectiveness of a facility’s sanitation program and can signal to FSIS if follow up is needed (for example, a Food Safety Assessment, intensified sampling, or enforcement actions).
  • FSIS will leverage the expertise of its National Advisory Committee on Microbiological Criteria for Foods (NACMCF). NACMCF is a federal advisory committee that provides scientific advice and recommendations to USDA and other government agencies on microbiological and public health issues. In December, FSIS will begin recruitment for new committee members, who will be given the specific charge of reviewing the agency’s regulatory approach to Listeria monocytogenes. Expertise in Listeria will be sought for membership. The committee’s input will be used to guide more long-term policy changes.

Equipping FSIS Inspectors with Updated Training and Tools to Recognize and Respond to Systemic Food Safety Issues

  • FSIS will update its instructions and training for food safety inspectors to better equip the workforce to recognize and highlight systemic problems in a standardized way. Agency inspectors will receive updated instructions and training, and FSIS field supervisors will routinely review these instructions with inspectors to ensure full understanding and appropriate application. Inspectors will also receive supplemental Listeria monocytogenes control training designed to help strengthen inspectors’ understanding of the regulatory requirements in FSIS’ Listeria Rule and how to verify establishments have designed and implemented food safety systems that comply with those requirements.
  • FSIS will conduct Food Safety Assessments (in-depth food safety reviews) at ready-to-eat meat and poultry facilities. In FY 2025, FSIS is prioritizing completion of Food Safety Assessments at ready-to-eat meat and poultry facilities that rely exclusively on sanitation measures to control for Listeria. These reviews will provide information about the plants individually and collectively and could inform future policy or process changes to target this microorganism.
  • FSIS field supervisors will conduct in-person, follow-up visits when systemic issues are identified during a Food Safety Assessment. Follow-up visits by FSIS field supervisors will bolster oversight from more senior inspection staff to ensure a facility fully addresses issues identified during a Food Safety Assessment and could inform enforcement action by FSIS. Field supervisors will work with inspectors to ensure the facility stays in compliance.

Tightening Oversight of Regulated Establishments, Including Those Under State Inspection Models

  • FSIS inspectors will verify specific Listeria monocytogenes-related risk factors at ready-to-eat facilities weekly. These risk factors include changes in physical plant modifications, such as new construction; indicators of sanitation problems, such as condensation, roof leaks, damaged equipment, or cracked floors; and Listeria species or Listeria monocytogenes positive test results from company testing. FSIS district offices, agency field supervisors and inspectors will review, analyze and consider the weekly data from each facility to determine if there are systemic issues that warrant further action, such as a Food Safety Assessment, intensified sampling, or enforcement steps.
  • FSIS will clarify state and Federal requirements for consistent oversight of Talmadge-Aiken (TA) programs through updated cooperative agreements and instructions. Through updated cooperative agreements with each participating state, FSIS will set specific requirements, including clear expectations for oversight, enforcing federal food safety laws, comprehensive federal training for TA inspectors, and enhanced regular coordination with FSIS. FSIS will also designate field and headquarters positions assigned to TA oversight; will clarify training requirements and criteria to start, maintain and terminate state inspection coverage of an establishment.
  • FSIS will revise establishment-review alert triggers. One significant criterion used to guide a district office’s decision to conduct a Public Health Risk Evaluation (PHRE), which typically precedes a Food Safety Assessment, is a monthly list of facilities with higher rates of noncompliance related to public health that is generated using an algorithm. Using additional data from the new weekly verification of Listeria monocytogenes-related risk factors, FSIS intends to update its algorithm and triggers to better identify high-risk facilities.

According to a USDA press release, these actions are intended to strengthen FSIS’ inspection and oversight by enhancing its ability to proactively identify and respond to the types of systemic problems that could lead to outbreaks. Listeria monocytogenes is a pathogen of particular concern because it can be especially harmful to people with compromised immune systems, like the elderly and pregnant women, and it can contaminate foods that are not cooked before consumption.

FSIS is continuing to identify other steps that would improve control of Listeria monocytogenes, dependent on funding availability. As requested in the FY 2025 President’s Budget, additional resources are necessary for the agency to continue to meet its mission to keep meat, poultry, and egg products safe and wholesome.

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Beltway Beat

USDA Proposes New Policy to Reduce Salmonella in Raw Poultry Products

By Food Safety Tech Staff
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On July 29, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) issued a comprehensive proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products. According to the USDA’s website, this is the culmination of FSIS’ three-year effort to reevaluate their strategy for controlling Salmonella rates in poultry and protect American consumers from foodborne illness linked to consumption of poultry products.

The proposal would establish final product standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 colony forming units (CFU) per gram/ml and any detectable level of at least one of the Salmonella serotypes of public health significance from entering commerce. The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I,4,[5],12:I:- ; and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen. The proposal would also require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination throughout the slaughter system.

“The proposed Salmonella framework is grounded in data and rigorous scientific evaluation, and it reflects feedback from extensive stakeholder engagement,” said USDA Under Secretary for Food Safety Dr. Emilio Esteban. “We encourage all interested stakeholders to submit comments and relevant data on the proposal as we work to finalize data-driven, science-based regulatory policies to address Salmonella in poultry.”

Michelle Catlin

USDA FSIS Appoints New Chief Scientist

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Michelle Catlin

The USDA Food Safety and Inspection Service (FSIS) has announced that Michelle Catlin, Ph.D., will serve as Chief Scientist of FSIS, effective December 31, 2023. In this role, Dr. Catlin will serve as the primary scientific advisor on matters of public health and food safety that affect the mission of the agency, with primary responsibility for scientific initiatives within the Office of Public Health Science (OPHS).

Dr. Catlin has more than 20 years of experience in the public health field. From 1999 through 2004 she worked for National Academy of Sciences. In 2004, Dr. Catlin joined FSIS as a senior scientist. She most recently served the agency as the International Coordination Executive, overseeing all of FSIS’ international activities. Dr. Catlin holds a Bachelor of Science (Honors) in life sciences and a Master of Science in pharmacology from Queen’s University at Kingston, Ontario, Canada, and a Ph.D. in toxicology from the Department of Environmental Health of the University of Washington at Seattle.

 

Cattle

USDA Report Highlights Multi-Year Trends for Salmonella Antimicrobial Resistance

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The USDA Food Safety and Inspection Services (FSIS) has released a report highlighting Salmonella antimicrobial resistance (AMR) trends from 2014-2019. The FSIS NARMS Multi-Year Report evaluates trends in Salmonella serotypes and antimicrobial resistance (AMR) in certain food animal species and products sampled from 2014 through 2019 as part of FSIS NARMS sampling.

The National Antimicrobial Resistance Monitoring System (NARMS) is a national public health surveillance system through which FSIS partners with state and local public health departments, the CDC, and the FDA to track changes in antimicrobial susceptibility of select foodborne bacteria found in ill people, retail meats, and food animals.

Hear from Sandra Eskin, Deputy Under Secretary for Food Safety, Food Safety and Inspection Service, USDA, on the Proposed Regulatory Framework to Reduce Salmonella Illness at Food Safety Tech’s Hazards Conference, April 3-5 in Ohio.Samples analyzed included cecal (intestinal content) samples from food-producing animals at slaughter and product samples tested as part of Pathogen Reduction/Hazard Analysis Critical Control Point (PR/HACCP) sampling. Salmonella isolates were analyzed by serotyping and antimicrobial susceptibility testing (AST) to evaluate differences in sample source and slaughter class (chicken, turkey, cattle, and swine).

FSIS’ key findings indicate that:

  • The proportion of pan-susceptible Salmonella differed among slaughter classes and sample sources (cecal/product samples): cattle (83%/71%), swine (65%/64%), chicken (35%/43%), and turkey (34%/32%).
  • The top Salmonella serotypes for each slaughter class were Kentucky (chicken), Reading (turkey), Montevideo (cattle), and Anatum (swine).
  • Salmonella Infantis showed an increasing trend in chicken and emerged as one of the top serotypes in both cecal and product samples.
  • Salmonella Infantis from both cecal and product samples showed increased multidrug-resistance.
  • Salmonella isolates from chicken cecal and product samples show a significant increase in resistance to the critically important antimicrobial drugs: ciprofloxacin, ceftriaxone, and trimethoprim-sulfamethoxazole.
  • Over time, Salmonella isolates from product samples from cattle and swine showed increased resistance to cephalosporin.

FSIS noted that differences and similarities observed in Salmonella serotypes and their AMR between cecal and product samples highlight the importance of monitoring Salmonella from farm-to-slaughter.

Read the full report here.

 

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USDA FSIS Publishes 2023-2026 Strategic Plan

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The USDA Food Safety and Inspection Services (FSIS) has released its 2023-2026 Strategic Plan, the foundation document for both the long range and day-to-day operations of the agency. The agency announced that the updated plan continues to emphasize the importance of science and data to implement advanced and innovative approaches to food safety.

The plan includes three strategic goals:

Goal 1: “Prevent Foodborne Illness and Protect Public Health,” which focuses directly on FSIS’ public health mission and its activities.

Goal 2: “Transform Inspection Strategies, Policies, and Scientific Approaches to Improve Public Health,” which focuses on improving how the agency conducts food safety activities.

Goal 3: “Achieve Operational Excellence,” which focuses on maintaining and improving the strong internal foundation needed to meet goals 1 and 2.

As part of the primary goal, “Prevent Foodborne Illness and Protect Public Health,” the FSIS specifically plans to:

  • Advance a proposed regulatory framework for its new strategy to reduce Salmonella infections attributable to poultry. FSIS is considering: (1) requiring that incoming flocks be tested for Salmonella before entering an establishment; (2) enhanced establishment process control monitoring and FSIS verification; and (3) an enforceable final product standard. This proposed strategy is aimed at moving the Agency closer to achieving the national target of a 25% reduction in Salmonella illnesses set by Healthy People 2030 and is expected to be in place by May 2024.
  • Strengthen compliance with food safety statutes and regulations by:
    • Regularly assessing domestic food safety systems to determine how well they are maintaining process control as well as leveraging data from the Public Health Information System (PHIS) to identify patterns and trends in noncompliance with FSIS regulations among establishments.
    • Conducting outreach, technical assistance, and information sharing with other countries to improve understanding of FSIS’ regulatory requirements and policies. This is to ensure food safety standards for imported products are equivalent to those of domestic products to reduce foodborne infections attributable to FSIS-regulated products, specifically for Salmonella illnesses attributable to poultry.
  • Improve food safety at in-commerce facilities by using a risk-based approach to target FSIS resources—including resources used for surveillance, investigative, and enforcement activities.
  • Enhance response to outbreaks by improving information sharing and collaboration with public health partners during investigations to remove contaminated product more quickly from commerce.
  • Sustain progress in food defense by assuring that establishments adopt and incorporate food defense practices into their day-to-day operations, and that agency personnel and industry are prepared to respond to an act of intentional contamination.
  • Increase public awareness of recalls, public health alerts, foodborne illness outbreaks, and consumer adoption of safe food handling practices, by identifying the best approaches to influence behavior and deploying proactive strategies based on behavioral science research.
Jose Emilio Esteban, Ph.D.

José Emilio Esteban, Ph.D. Sworn in as USDA Under Secretary for Food Safety

By Food Safety Tech Staff
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Jose Emilio Esteban, Ph.D.

On January 4, José Emilio Esteban, Ph.D. was sworn in as the new Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA). Dr. Esteban joined the USDA Food Safety and Inspection Service in 2001 and was appointed Chief Scientist of the FSIS in August 2018.

“Dr. Esteban has a long and well-documented commitment to food safety and public health. With over two decades of experience at USDA’s Food Safety and Inspection Service, he has been on the front lines of protecting the public from foodborne illness for much of his career,” said USDA Agriculture Secretary Tom Vilsack. “I am confident that Dr. Esteban’s leadership and experience is the right combination to advance our commitment to maintaining public health and reducing foodborne illness. I look forward to working with him as USDA continues to address foodborne challenges head-on with innovative solutions and proactive measures.”

Prior to joining the USDA, Dr. Esteban worked at the Centers for Disease Control and Prevention and served as chair of the Codex Alimentarius Commission Committee on Food Hygiene.

“Serving as the next Under Secretary of Food Safety is an opportunity to give back to a nation that has given me so much,” said Dr. Esteban.

 

Upside Foods Chicken

Lab Grown Meat Passes Key Safety Hurdle on Path to Approval

By Food Safety Tech Staff
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Upside Foods Chicken

On November 16, the FDA announced that it had completed its first pre-market consultation for a human food made from cultured animal cells. After evaluating the information submitted by UPSIDE Foods, a company that uses animal cell culture technology to take living cells from chickens and grow the cells in a controlled environment to make the cultured animal cell food, the agency stated that it had no further questions at this time about the firm’s safety conclusion.

In a statement from Commissioner Robert M. Califf, M.D., and Susan Mayne, Ph.D., director of the FDA Center for Food Safety and Applied Nutrition, the regulators explained that before this food can enter the market, the facility in which it is made also needs to meet applicable U.S. Department of Agriculture (USDA) and FDA requirements. In addition to the FDA’s requirements, including facility registration for the cell culture portion, the manufacturing establishment needs a grant of inspection from the USDA Food Safety and Inspection Service (FSIS) for the harvest and post-harvest portions as well as a USDA mark of inspection the product itself.

Cultivation Room Upside
UPSIDE Foods Cultivation Room

UPSIDE Foods’ CEO Uma Valeti, M.D., celebrated the news with a mock letter to the chickens of the world. “So what does getting a ‘No Questions Letter’ mean, exactly? It means that the FDA accepts our safety conclusion and UPSIDE’s cultivated chicken will be available following USDA inspection and label approval. It’s an important step on the road to bringing cultivated chicken to the market in the U.S., and gets UPSIDE closer to being on tables everywhere,” said Valeti. “And what does that mean? It means a whole new future is around the corner. And in that future, we might be eating just as much meat as we always have. But a lot fewer animals are going to have to suffer for it.”

Now that the pre-market consultation is completed, the approval process will transition from the FDA to USDA FSIS oversight. USDA FSIS will oversee the post-harvest processing and labeling.

“The FDA is ready to work with additional firms developing cultured animal cell food and production processes to ensure their products are safe and lawful under the Federal Food, Drug, and Cosmetic Act,” said Drs. Cardiff and Mayne. “We also plan to issue guidance to assist firms that intend to produce human foods from cultured animal cells to prepare for pre-market consultations. The published draft of this guidance will provide a formal opportunity to the public for comment.”

chicken, beef, dairy, lettuce

Foodborne Illness Report Highlights High-Risk Food Categories

By Food Safety Tech Staff
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chicken, beef, dairy, lettuce

This month, the Interagency Food Safety Analytics Collaboration’s (IFSAC) released it newest annual report , “Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States.” IFSAC is a collaboration between the CDC, FDA and USDA Food Safety and Inspection Service (FSIS).

The report was developed to help shape the priorities of the FDA, inform the creation of targeted interventions to reduce foodborne illnesses caused by these pathogens, inform stakeholders and improve regulatory agency’s to assess whether prevention measures are working.

The report identified 3,749 outbreaks that occurred from 1998 through 2020 and were confirmed or suspected to be caused by Salmonella, E. coli O157, or Listeria, including 192 outbreaks that were confirmed or suspected to be caused by multiple pathogens or serotypes.

The IFSAC excluded 96 of these outbreaks according to its pathogen-exclusion criteria, leaving 3,653 outbreaks. The agency further excluded 1,524 outbreaks without a confirmed or suspected implicated food, 836 outbreaks for which the food vehicle could not be assigned to one of the 17 food categories, and six that occurred in a U.S. territory.

The resulting dataset for the report included 1,287 outbreaks in which the confirmed or suspected implicated food or foods could be assigned to a single food category. These included 960 caused or suspected to be caused by Salmonella, 272 by E. coli O157 and 55 by Listeria. Outbreaks from 2016 through 2020 provide 71% of model-estimated illnesses used to calculate attribution for Salmonella, 67% for E. coli O157 and 62% for Listeria.

Salmonella illnesses came from a wide variety of foods, with more than 75% of illnesses attributed to seven food categories: Chicken, Fruits, Pork, Seeded Vegetables (such as tomatoes), Other Produce (such as fungi, herbs, nuts, and root vegetables), Beef and Turkey.

More than 80% of E. coli O157 illnesses were linked to Vegetable Row Crops (such as leafy greens) and Beef.

More than 75% of Listeria monocytogenes illnesses were linked to Dairy products, Fruits and Vegetable Row Crops, though the IFSAC noted that “the rarity of Listeria monocytogenes outbreaks makes these estimates less reliable than those for other pathogens.”

Attribution estimates for Campylobacter outbreaks were not included in this year’s report, though they have been included in the past. IFSAC said that this was “due to continued concerns about the limitations of using outbreak data to attribute Campylobacter illnesses to sources … these concerns are largely due to the outsized influence of outbreaks in certain foods that pose a high individual risk for Campylobacter infection but do not represent the risk to the general population.” For example, 91% of reported Campylobacter outbreaks related to dairy products were associated with unpasteurized milk, while 57% majority of chicken-related outbreaks were due to chicken liver products, which are not widely consumed.

Raw chicken breast

USDA Charts Regulatory Path To Reduce Poultry-Linked Salmonella Infections

By Food Safety Tech Staff
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Raw chicken breast

The USDA Food Safety and Inspection Service (FSIS) has released a proposed regulatory framework to control Salmonella contamination in poultry products.

In its announcement, the USDA noted that the proposed framework follows months of information-gathering and discussions with a wide range of stakeholders, researchers and scientists. It consists of three key components:

  • Requiring that incoming flocks be tested for Salmonella before entering an establishment
  • Enhancing establishment process control monitoring and FSIS verification
  • Implementing an enforceable final product standard.

“We know that Salmonella in poultry is a complex problem with no single solution,” said USDA Deputy Under Secretary Sandra Eskin. “However, we have identified a series of strategic actions FSIS could take that are likely to drive down Salmonella infections linked to poultry products consumption, and we are presenting those in this proposed framework.”

A copy of the proposed framework, which also addresses cross-cutting issues of testing for Salmonella, the impact on small and very small establishments and data sharing, is available online here.

Representatives from industry, consumer groups and other stakeholders are invited to provide input on the proposed regulatory framework by participating in a virtual public meeting November 3 from 10am to 4pm ET via Zoom. To view the agenda and to register to attend, visit the Meetings and Events page on the FSIS website.

Stakeholders can also submit written comments at www.regulations.gov.

Consumer groups are applauding the proposed framework. “This is a historic first step toward final product standards that are science-based, risk-based, enforceable, and effective at protecting our vulnerable loved ones,” said Amanda Craten, board member of STOP Foodborne Illness. “As a parent of a child who suffered from Salmonella illness and is left with permanent injury, I have advocated and engaged in the process to modernize poultry standards to ensure no child has to experience the devastation of a preventable, virulent Salmonella illness. I’m thankful that USDA is making the prevention of illnesses like my son Noah’s a priority.”

Dr. Craig Hedberg, a professor at University of Minnesota School of Public Health and Co-Director of the Minnesota Integrated Food Safety Center of Excellence, agrees that this framework “is an important step towards moving away from hazard-based regulation toward risk-based regulation. Focusing on levels of Salmonella and highly virulent strains of Salmonella rather than just the presence or absence of Salmonella should reduce the number of illnesses associated with poultry.”

The USDA FSIS continues to gather scientific evidence relevant to the approaches presented in the proposed framework.

 

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USDA FSIS To Host Webinar on Expanded Data Access for PHIS

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The USDA Food Safety and Inspection Service (FSIS) is inviting industry to take part in a webinar on October 4, 2022, from 1pm to 2 pm ET to learn more about the expanded functions in the Public Health Information System (PHIS) for industry users, which was announced in the September 9, 2022, Constituent Update.

The expansion, launching in October, will allow industry users to review and suggest modifications to FSIS data associated with their establishment profile, such as product volumes and product groups. FSIS inspection program personnel will then be able to verify and approve or deny the modifications within PHIS.

Pre-registration for the webinar is not required. Attendees can access the webinar on the FSIS website event page. A recording of the webinar, along with presentation slides, will be posted on the FSIS website for those unable to attend.