Tag Archives: FDA

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 SalmonellaEscherichia 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.

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FDA Submits Final FSMA Rule for Food Traceability

By Food Safety Tech Staff
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On November 7, the FDA sent the FSMA Final Rule: Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal Register (OFR).

The final rule includes a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). The FDA notes that while the proposed requirements only apply to those foods on the FTL, “they were designed to be suitable for all FDA-regulated food products. FDA would encourage the voluntary adoption of these practices industrywide.”

The final rule will become effective 60 days after it is published in the Federal Register, which the FDA anticipated would happen within one to two weeks. The compliance date for all persons subject to the recordkeeping requirements is two years after the effective date.



FDA Poised To Increase Color Certification Fees

By Food Safety Tech Staff
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On November 1, the FDA issued a proposed rule to amend the color additive regulations with a 10 cent per pound increase in color certification fees. If the rule is finalized, this would be the first increase since 2005 when the current schedule became effective.

In its announcement of the proposed rule, the FDA said the increase in fees is necessary to cover increased operating costs “in order to ensure the color certification program continues operating at the high level of quality and efficiency that industry expects.”

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the FDA for use in food, drugs, cosmetics and medical devices. The FDA analyzes samples from each batch of color additive received from a manufacturer to verify that it meets composition and purity specifications. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.

Stakeholders can submit electronic comments on the proposed rule at http://www.regulations.gov or send written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2022-N-1635.



National Advisory Committee Announces Public Meeting to Discuss Actions on Cronobacter, Cyclospora and Salmonella


The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a virtual public meeting on November 15 from 10:00 am to 12:00 pm ET to discuss work being advanced by the FDA on Cronobacter spp. in powdered infant formula. The Committee will also discuss updates under the Cyclospora cayetanensis subcommittee and vote on adopting the report: “Enhancing Salmonella Control in Poultry Products.”

NACMCF is an advisory committee, established by the USDA, that provides impartial, scientific advice and/or peer reviews to federal food safety agencies for use in the development of an integrated national food safety systems approach.

The meeting is intended to help the committee gain scientific insight regarding Cronobacter infections, including recommendations for how public health authorities can better protect public health, as well as recommendations for food safety management practices that the food industry can implement to enhance the safety of powdered infant formula.

The meeting will be held virtually using Zoom. Attendees must pre-register to receive a join link, dial-in number, access code and unique Attendee ID. Attendees who would like to deliver comments during the meeting must register by November 8, 2022. Attendees who do not plan to speak at the public meeting may register at any time up to the day of the meeting. The meeting agenda is available on the FSIS events page.


Sara Bratager

Traceability and the Need for Global Standards

By Food Safety Tech Staff
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Sara Bratager

The FDA will officially implement a new food traceability rule on November 7, 2022. While the new rule requires a detailed account of food’s origin and movements throughout production, processing and shipping, the food industry still lacks international standardized guidelines that factor in countries’ varying health and agricultural priorities. As this continues to be one of the global food system’s biggest challenges, we spoke with Sara Bratager, Food Traceability & Food Safety Scientist at the Institute of Food Technologists, to discuss where the food industry stands currently, and opportunities to establish a global standard that is mutually beneficial (and achievable) for all. 

The FDA is scheduled to finalize new FSMA traceability rule on November 7. What are some of the key changes that food manufacturers and suppliers will need to address with the new rule?

Bratager: The finalized rule will be published in November. Based on the proposed rule, it will go into effect in January 2023 (60 days after publication) and companies will have two years after that to make any adjustments needed to achieve compliance. Entities that produce, process, ship or receive any of the products on the Food Traceability List will need to capture and store the established Key Data Elements (KDEs) at each of the Critical Tracking Events (CTEs) relevant to their operation. The rule will also require companies to provide electronic traceability information to the FDA no more than 24 hours after a request is made, necessitating a significant transition from traditional paper-based traceability systems.

How prepared is the food industry to implement these changes?

Bratager: Preparedness differs throughout the food industry; some industry actors have been preparing since the release of the proposed rule, while others have chosen to forgo significant effort pending finalization of the rule. Some entities may have even engaged in unintentional preparation; companies or commodities that have been the subject of repeated recalls and subsequent traceability initiatives will likely find themselves better prepared than traceability newcomers. The food tech industry is prepared to deliver digital traceability solutions that facilitate compliance among supply chain actors, but implementation is likely to be a challenge for many. Some operations will achieve compliance with minimal disruption, whereas others will face a more burdensome effort.

How will this affect companies working with global suppliers?

Bratager: The proposed rule covers any ingredients or foods on the Food Traceability List that may be sourced from global suppliers. One of the biggest challenges for companies working with global suppliers will be coordination and communication between supply chain partners. Some companies may find themselves responsible for educating their international trading partners on FSMA requirements. However, understanding will not guarantee compliance. Some global suppliers are already reporting traceability data for domestic or other export requirements and will be hesitant to take on the burden of yet another traceability scheme. The increasingly globalized nature of our food system highlights the need for traceability standards that streamline data collection and reporting efforts through the supply chain.

Are there any efforts underway to develop global standards related to food traceability?

Bratager: Several standards exist currently. The International Organization for Standardization’s ISO 22005:2007 details basic requirements for the design and implementation of food/feed traceability systems at an organizational level. GS1, the organization best known for barcodes, provides several foundational standards for the identification, capture and sharing of data; their EPCIS standard that allows disparate applications to create and share traceability event data is particularly relevant.

Food operations are incredibly unique, and widespread standards uptake will likely require a degree of customization, which is why sector or commodity-specific efforts that build upon existing foundational standards are so important. The Global Dialogue on Seafood Traceability (GDST) provides a great example with their GDST 1.1 Standard for interoperable seafood traceability that is built upon GS1 foundations. A second example is the Produce Traceability Initiative (PTI).

How can the industry and regulators move toward developing a global standard for traceability in the food industry?

Bratager: A necessary first step is alignment around the definition of traceability. Regulatory agencies and industry actors across the globe adhere to different definitions but cohesive, global progress will require alignment around a common definition for traceability.

Industry can support the creation and uptake of pre-competitive, commodity-based traceability initiatives that drive adopters toward common practices and data standardization. Interoperability must also be prioritized. Demand for interoperable data sharing will necessitate and incentivize widespread adoption of data standards.

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FDA Announces Upcoming Webinars on Food Safety Culture and “Healthy” Food Labeling

By Food Safety Tech Staff
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The FDA has announced two upcoming webinars for food manufacturers and industry stakeholders. On Friday, October 21, 2022, at 1:00 pm ET, the FDA will provide an overview of its proposed rule to update the definition of “healthy” nutrient content claims for food products. The “healthy” claim acts as a quick signal on food package labels to identify foods that will help consumers build healthy eating patterns.

The FDA has proposed changes to the definition of “healthy” to align with current nutrition science, the Dietary Guidelines for Americans, 2020-2025 and the updated Nutrition Facts label. The guidance also includes the agency’s intent to exercise enforcement discretion with respect to the implied nutrient content claim “healthy” for foods that have a fat profile of predominantly monounsaturated and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” and on foods that contain at least 10% of the daily value (DV) per reference amount customarily consumed of potassium or vitamin D.

Speakers include:

  • Janesia Robbs, Communications and Public Engagement Staff, FDA CFSAN
  • Dr. Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling (ONFL), FDA CFSAN
  • Dr. Sarah Gebauer, Nutritionist, Nutrition Science Review Branch, ONFL, FDA CFSAN
  • Vincent DeJesus, Nutritionist, Nutrition Assessment & Evaluation Branch, ONFL, FDA CFSAN

Registration is required. Register here.

On Wednesday, October 26, from 12:00 pm to 1:00 pm ET, the FDA and Stop Foodborne Illness, a nonprofit public health organization, will be host their fifth collaborative webinar, titled “Rewards and Recognition Programs.” Guest speakers will share their experiences in establishing rewards programs that drive positive food safety culture. Speakers include:

  • Shawn Fear, Director of Quality, Conagra Brands
  • Danielle Richardson, Director of Food Safety, Conagra Brands
  • Lone Jespersen, Principal and Founder, Cultivate, SA
  • Donald Prater, Associate Commissioner for Imported Food Safety, FDA
  • Conrad Choiniere, PhD, Director of the Office of Analytics and Outreach, FDA Center for Food Safety and Applied Nutrition (CFSAN)
  • Vanessa Coffman, Director, Alliance to Stop Foodborne Illness, Stop Foodborne Illness

Those who would like to attend the webinar can register here.


Jennifer Allen
Food Safety Attorney

Staying a Step Ahead on Produce Safety

By Jennifer Allen
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Jennifer Allen

The FDA continues to make revisions and improvements to its Produce Safety Rule, with input from various stakeholders. One thing that is a constant drumbeat is that food growers and manufacturers need to do a better job of keeping consumers safe from foodborne illness arising from produce that was traditionally thought of by consumers as safe to eat (think spinach, romaine lettuce and red onions). Through the produce regulations (21 CFR 112.1-112.213), the FDA is attempting to come to grips with the seemingly endless parade of produce-based outbreaks, arming the food industry with an additional weapon for use in the constant battle with foodborne illness.

The regulations, broadly speaking, require farms of a certain size to develop processes relating to employee hygiene and training, agricultural water, biological soil amendments (compost, manure and the like), and buildings and equipment to decrease the risk of contamination of produce during growing, harvesting, packing and holding. But what does that mean for food manufacturers?

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One way to understand the regulations is to consider them in the context of a dish that seems to be increasingly popular in restaurants: the beet salad. Starting with the beets, the regulations do not apply to them. Why? Because the regulations don’t apply to produce that is rarely consumed raw. The FDA has provided an exhaustive list of this kind of produce and beets are, not surprisingly, on that list.

But what about the rest of the salad. Typical beet salads often contain leafy greens like spinach and arugula, and other produce such as carrots and avocado. With the produce regulations in place, food manufacturers should expect, and even demand, a greater level of safety and accountability from their suppliers with respect to these kinds of produce. All of these salad ingredients are considered covered produce under the act. But even though the regulations cover these ingredients, whether they provide food manufacturers with greater guarantees of safety and accountability really depends on who is growing, harvesting, packing and holding the produce before it reaches the manufacturing facility.

Broadly speaking, the regulations only apply to farms, which are generally defined as those establishments that grow and harvest the produce. Facilities that pack and hold produce must also follow the new regulations if they are majority owned by a farm that grows and harvests the produce. Non-farm packing and holding facilities can choose between following the new regulations or following current good manufacturing practices generally applicable to all foods (you can find these practices at 21 CFR 117). Establishments that only hold or transport produce are not required to follow either regulation.

What’s more, not all farms are covered under the new regulations. Farms that on average sell less than $25,000 per year of produce, adjusted for inflation with 2011 as the baseline year, are not covered by the regulations at all. And farms that sell an average of less than $500,000 of food each year, adjusted for inflation, may seek an exemption from the regulations if the amount of food they sell each year direct to consumers—or to restaurants and retail establishments within the same state or less than 275 miles away—exceeds the amount of all other food sales. That means the smaller and more local the farms a manufacturer sources from, the less likely it is that the manufacturer must follow the new regulations. It also means that if produce is packaged and held by a middleman, that middleman may not have to follow the new regulations either.

How To Mitigate Risk When Sourcing Produce

How does a food manufacturer then develop the knowledge necessary to have some power over what enters its facility and what risks to accept in sourcing produce? Well, if produce comes directly from a farm covered under the new regulations, the manufacturer should make sure that its supply contract requires the farm to provide regular certification that its produce has been grown, harvested, packed and held in compliance with the regulations. The same goes for produce coming from a packing and holding facility that is majority farm-owned. But even if the produce comes from a non-farm packing and holding facility, manufacturers can seek reassurance of safety in several ways.

If a produce supplier is not covered under the FDA Produce Safety regulations, manufacturers can still require certification that their suppliers comply either with the produce safety regulations or with existing current good manufacturing practices. If manufacturers have strong bargaining power over non-farm suppliers, they might even consider requiring that the supplier voluntarily comply with all or some of the produce safety regulations. Or manufacturers could require that the supplier obtain certification from the grower that the produce was grown and harvested in compliance with the produce regulations or (for non-covered or exempt farms) that the grower otherwise complied with current good manufacturing practices.

Even if produce comes from non-covered or exempt farms, manufacturers may still consider asking the farm to follow basic practices that mitigate the risk of contamination. Although the produce regulations include certain larger-scale, and costly, measures, they also include some simple requirements that even small farms can implement cost-effectively.

Question manufacturers should consider include: Has a company representative visited the farm that grows its produce? If it has, did workers have access to bathrooms or handwashing facilities? How clean was the area where the workers sort and pack the produce?

Depending on the amount of bargaining power a manufacturer has, it might be able to convince the grower to install portable toilets or handwashing stations, or to clean up its sorting area. Even installing signs that instruct workers to wash their hands or report to a supervisor if they are sick, can go a long way toward mitigating the risk of contamination.

At minimum, manufacturers should keep good records showing who grew, harvested, packed and held their produce, so that in the event of an outbreak of a foodborne illness, they can provide FDA with essential information to help determine the source. Manufacturers should also ensure that their supply contracts contain provisions requiring suppliers to notify them promptly whenever the suppliers have reason to suspect that produce may have become contaminated.

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FDA and CDC Sign MOU for Enhanced Collaboration To Reduce Foodborne Illness

By Food Safety Tech Staff
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The FDA and CDC have entered into a Memorandum of Understanding (MOU) to strengthen food safety in retail environments. The goal of the renewed partnership is to help reduce the occurrence of foodborne illness in retail and foodservice establishments.

This MOU, which was signed on September 21, was developed to help increase the consistency and capacity of retail food protection programs across the country, promote a general culture of food safety and facilitate continued communication between the FDA and CDC to assist state, tribal, local, territorial (SLTL) and industry partners.

The three primary goals of the MOU include:

  1. Increase uniformity, consistency and capacity of STLT retail food protection programs
  2. Promote industry’s active managerial control (AMC) of foodborne illness risk factors and promote a culture of food safety
  3. Maintain a strong FDA National Retail Food Team (NRFT) and CDC National Center for Environmental Health (NCEH) workforce to assist STLT partners.

The agencies are seeking to: improve STLT’s effectiveness in conducting risk-based inspections and foodborne illness investigations; promote a culture of food safety and food safety management systems within retail and foodservice establishments; and improve research in support of foodborne illness risk factor reduction.

To accomplish these objectives, the FDA and CDC are both tasked with establishing metrics to measure the success of collaborations as well as establishing direct and consistent relationships at multiple organizational levels, sharing best practices, and identifying opportunities for leveraging the resources of both agencies to more efficiently and effectively support STLT retail regulatory programs as well as both FDA and CDC retail food protection initiatives.

In its announcement of the MOU, the FDA notes that it has historically worked with CDC to help control the risk factors for foodborne illness outbreaks in retail settings. “This MOU will ensure enhanced continued collaboration on this important work,” the agency wrote.

Brie Cheese

FDA Links Listeria monocytogenes Outbreak to Old Europe Cheese Brie and Camembert Soft Cheese Products

By Food Safety Tech Staff
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Brie Cheese

A multistate outbreak of Listeria monocytogenes infections has been linked to Brie and Camembert soft cheese products manufactured by Old Europe Cheese, Inc. of Benton Harbor, Michigan. The products are sold at various retailers under multiple labels and brands. Six cases of illness have been reported in patients in California, Georgia, Massachusetts, Michigan, New Jersey and Texas.

The FDA reports that epidemiologic information provided by CDC found that, of the five patients with information available, four reported eating Brie or Camembert cheese prior to their illnesses. An FDA inspection of the Old Europe Cheese, Inc. facility in Michigan, performed with assistance from the Michigan Department of Agriculture and Rural Development, showed the presence of Listeria monocytogenes. Whole Genome Sequencing (WGS) analysis determined that the Listeria strain found in the facility matches the Listeria strain causing illness in this outbreak.

The company has voluntarily recalled multiple brands of its Brie and Camembert cheeses produced at the facility in response to the investigation findings. The firm has also halted production and distribution of its Brie and Camembert products from the Michigan facility and is working with FDA on corrective actions.

Consumers, restaurants and retailers should not eat, sell or serve recalled products and should throw them away; this includes Best By Dates ranging from September 28, 2022 to December 14, 2022—all flavors and quantities. A full list of recalled products and stores that potentially sold these products is available on the firm’s recall.

enokie mushrooms

Bulb Onions and Imported Mushrooms Focus of New FDA Food Safety Prevention Strategies

By Food Safety Tech Staff
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enokie mushrooms

The FDA has announced two new food safety prevention strategies. The first is for imported enoki and wood ear mushrooms. The second is focused on bulb onions. Both food groups were identified in foodborne illness outbreaks in 2020.

In 2020, a multistate outbreak of Listeria monocytogenes (L. monocytogenes) infections that sicked 26 people was linked to the consumption of imported enoki mushrooms. Testing conducted by the California Department of Public Health (CDPH) identified a matching strain of L. monocytogenes in enoki mushrooms from the Republic of Korea.

Also in 2020, CORE, in collaboration with the CDC and state and local partners, investigated a multistate outbreak of Salmonella Stanley infections linked to the consumption of imported wood ear mushrooms. A total of 55 salmonellosis illnesses were reported in 12 states. Testing conducted by CDPH identified a matching strain in a sample of imported wood ear mushrooms from China. These were the first outbreaks reported to FDA in 20 years related to these products.

As a result of the outbreak findings, the FDA will conduct research to better understand how L. monocytogenes contaminates enoki mushrooms and to better understand the survival of L. monocytogenes and Salmonella on enoki mushrooms and wood ear mushrooms.

The agency will also increase strategic and targeted FDA sampling of imported specialty mushrooms at U.S. ports of entry and at U.S.-based retail sites on the state level. When specific producers are linked to the contaminated shipment, FDA may also detain future shipments until the producer can assure the FDA that the conditions that gave rise to the appearance of the violation have been resolved.

The FDA will also be working with industry to ensure international specialty mushroom producers have access to training intended to help them meet requirements for ensuring the safe production of mushrooms for import into the U.S.

Bulb Onions

In 2020 and 2021, Salmonella outbreaks associated with the consumption of bulb onions produced in the U.S. and Mexico caused more than 2,100 confirmed cases of foodborne illness in the United States.

As a result of the outbreak investigation, the FDA will engage domestic and foreign industry and government partners to promote a broad understanding of the outbreak investigation findings, applicable Produce Safety Rule requirements and the importance of root cause analysis after outbreaks.

Additional actions under the new safety prevention strategy include:

  • Prioritizing inspections of bulb onion farms in the U.S. and Mexico that are covered by the FDA’s Produce Safety Rule.
  • Identifying and assessing practices and conditions associated with onion curing.
  • Supporting research efforts to better understand bulb onion production practices, including the impact of different soil conditions and curing practices on the safety of bulb onions.
  • Supporting industry-led efforts to develop and implement best practices for bulb onion production.
  • Prioritizing Foreign Supplier Verification Program inspections of bulb onion importers to ensure that onion importers are verifying that foreign suppliers follow processes and procedures that provide the same level of public health protection as U.S. food safety requirements.
  • Increasing strategic and targeted sample collection and testing of imported bulb onions from the State of Chihuahua, Mexico.
  • Continuing to collaborate with Mexican competent authorities through the established Food Safety Partnership to help ensure the safe production of bulb onions in the State of Chihuahua, Mexico.