Tag Archives: USDA FSIS

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 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.

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.

 

USDA Logo

USDA FSIS To Host Webinar on Expanded Data Access for PHIS

By Food Safety Tech Staff
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USDA Logo

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.

Milk and eggs

Undeclared Allergens Drive New Recall

By Food Safety Tech Staff
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Milk and eggs

Undeclared allergens continue to drive recalls from the USDA Food Safety and Inspection Service (FSIS). Last week, more than 22,000 pounds of frozen beef products were recalled because the products were found to contain milk, which was not declared on the label.

The USDA FSIS announced on September 17 that Valley International Cold Storage Acquisition, LLC, a Harlingen, Texas-based business, is recalling approximately 22,061 pounds of frozen beef products. The frozen products are labeled as Korean-Style Beef, but contain a chicken sausage and pepper product, which contains milk.

These items were produced on July 22, 2022. The following products are subject to recall [view labels]:

  • 9.25-oz. cartons labeled as “Healthy Choice POWER BOWLS Korean-Style Beef” with lot code “5246220320” and a “best if used by” date of 04-18-2023.

The products subject to recall, which were shipped to retail locations nationwide, have establishment number “34622” on the end flap of the carton.

On September 16, the USDA FSIS issued a public health alert for certain raw, ready-to-cook chicken entrée products that may contain egg, which is not declared on the finished product label. The agency noted that a recall was not requested because the products are no longer available for purchase.

The bacon-cheddar chicken entree products were produced on Sept. 9, 2022 and are labeled as [view labels]:

  • 12 oz. plastic wrapped metal containers containing “aprons READY TO COOK MEAL FOR ONE BACON-CHEDDAR SMOTHERED CHICKEN” with a use by date of 9/21/2022.

The products bear establishment number “P-48176” inside the USDA mark of inspection. These items were shipped to Publix locations in Alabama, Florida, Georgia, North Carolina, South Carolina, Tennessee and Virginia.

Consumers with an egg allergy who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Romaine Lettuce

Wendy’s Pulls Romaine Lettuce Over E. Coli Concerns

By Food Safety Tech Staff
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Romaine Lettuce

A multi-state outbreak of E. coli led Wendy’s to take the precautionary measure of removing romaine lettuce being used in sandwiches from restaurants in the region of the outbreak.

The CDC reports that as of August 18, 2022, a total of 37 people infected with the outbreak strain of E. coli O157:H7 have been reported from Michigan, Indiana, Ohio and Pennsylvania. The illnesses started on dates ranging from July 26, 2022, to August 8, 2022.

A specific food has not yet been confirmed as the source of this outbreak, but among 26 people who have been interviewed, 22 (86%) reported eating sandwiches with romaine lettuce at Wendy’s restaurants in Michigan, Ohio or Pennsylvania in the week before their illness started. Based on this information, Wendy’s removed the romaine lettuce being used in sandwiches from restaurants in those regions.

A spokesperson for Wendy’s released the following statement: “We are fully cooperating with public health authorities on their ongoing investigation of the regional E. coli outbreak reported in certain midwestern states. While the CDC has not yet confirmed a specific food as the source of that outbreak, we have taken the precaution of discarding and replacing the sandwich lettuce at some restaurants in that region. The lettuce that we use in our salads is different, and is not affected by this action. As a company, we are committed to upholding our high standards of food safety and quality.”

The CDC emphasized that it is not advising that people avoid eating at Wendy’s restaurants or that people stop eating romaine lettuce.

The CDC, public health and regulatory officials in several states, the FDA and the USDA-FSIS are collecting and analyzing data at the ingredient level to identify the food source of the outbreak, confirm whether romaine lettuce is the source and determine if there are any other possible foods that could be the source of the outbreak.

 

Recall

Frozen Pizza Recalled Due to Possible Foreign Object Contamination

By Food Safety Tech Staff
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Recall

Home Run Inn Frozen Foods is recalling approximately 13,099 pounds of frozen meat pizza product that may be contaminated with metal materials. The USDA FSIS announced the recall on August 14.

The problem was discovered when the Woodbridge, Illinois-based company notified FSIS that it had received consumer complaints reporting that metal was found in the pizza.

The pizzas were produced on June 6, 2022, and include the 33.5 oz. “Home Run Inn CHICAGO’S PREMIUM PIZZERIA DELUXE SAUSAGE CLASSIC PIZZA” with “best by” date of 12/03/22 (view labels). The products subject to recall have the establishment number “EST. 18498-A” inside the USDA mark of inspection. These items were shipped to a distributor in Illinois and then further distributed to retailers.

There have been no confirmed reports of injuries or adverse reactions due to consumption of these products.

Distributors and retailers are urged not to sell these products. Consumers who have purchased these products are urged not to consume them and either throw them away or return them to the place of purchase.

Miguel Villa

USDA FSIS Integrates Salmonella Quantification Testing into Regional Labs

By Food Safety Tech Staff
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Miguel Villa

In June, the USDA Food Safety and Inspection Services (FSIS) announced that it was rethinking its approach to Salmonella in poultry based on a review of data from 2015 to 2020 that showed a higher than anticipated reduction in Salmonella-contaminated chicken parts but no corresponding decrease in Salmonella-related illnesses attributable to poultry products.

Part of the new approach, shared in July, is the integration of Salmonella quantification testing in FSIS regional laboratories. The agency is now using GENE-UP QUANT Salmonella assay from bioMérieux, a non-enrichment quantification diagnostic tool for Salmonella.

We spoke with Miguel Villa, vice president of industrial applications for the Americas at bioMérieux to learn more about the new assay and how quantification methods may better serve public health initiatives.

Food Safety Tech (FST): How did your work with USDA FSIS come about?

Villa: bioMerieux is a French company with many, many years in the field of in vitro diagnostics. The background of the company is in human health care and life sciences. The legacy of this group is in vaccines going back to the time of Louis Pasteur. In fact, the founder of the group was a disciple of Louis Pasteur.

For the past 30 years, we have also been designing and manufacturing diagnostic tools and tests for the pharmaceutical and food industries. And for the past three years we—and other companies—have been in dialogue with the USDA FSIS and the FDA about the use of quantification for food safety and food testing for the benefit of public health.

There was discussion about the fact that, after years and years of better controls, increased testing and an increasing regulatory framework around food safety the level of foodborne illness that we continue to see is not where the regulators or the public want it to be. Based on that, we have had discussions about what are the next steps and how can we take this further to reduce diseases that are coming from food sources. There is a lot of focus on animal protein products, and one of the main contaminants has been Salmonella.

FST: What are some of the concerns or limitations of the current or traditional standards of testing?

Villa: The regulations now are focused on the presence or absence of Salmonella, and the regulators have accepted recently that we need to do more. One of the things that has been discussed quite a bit is quantification—not only do we want to know whether Salmonella is present, we want to know how much is present. This is what the GENE-UP QUANT Salmonella assay measures.

How this works is, whenever the FSIS gets a particular sample that is positive, they will use the assay to check how much Salmonella there is to get a better understanding of what they’re dealing with in terms of risk to public health.

FST: This is a non-enrichment detection method, why is that important?

Villa: True quantification can only come from the original sample. If you do something to that sample to stimulate growth, the organism typically does not grow in a linear fashion or you might be promoting limits of growth in that medium. So, the picture you get after enrichment is not exactly what is in the original sample, which is what you’re trying to understand.

FST: Is the assay quantifying only the density of Salmonella in the sample or is it also looking at serotypes?

Villa: Only the quantity. We are not looking at serotypes at this stage, but we are involved in the development of serotyping tools based on what we see coming down the road.

FST: Is the technology behind the GENE UP QUANT assay a new technology or new to the food safety industry?

Villa: GENE UP is a PCR (polymerase chain reaction) test, and PCR has been around for more than 20 years, so the tool itself is not new. What is new—or what is recent—are the methods that we are using to develop tests. They are more accurate and precise. And they are able to use mathematical modeling to correlate the things that you see in the sample, quantify them and also assess them accurately from a sample that is not enriched.

In the future, we will use the same techniques to develop rapid, accessible tools to identify specific serotypes.

FST: The USDA FSIS has brought this testing into its regional laboratories, are food manufacturers and processors also using these in their facilities? Should they be thinking about that?

Villa: Now that it is public knowledge that the FSIS is using this testing and performing Salmonella quantification, they are educating the market about why they’re doing this. As a result, we are beginning to receive inquiries from clients of ours about the test. It is not a mandate at this stage, but for their own risk management processes, many companies will likely start incorporating it.

FST:  What is the benefit of quantification? Why is it important to regulators and food safety professionals to know not only if Salmonella is present, but how much?

Villa: The industry has been very interested in moving away from presence/absence testing only for a while, because many people think that not all Salmonella is pathogenic. In addition, we need to find better ways to gauge risk but at the same time not be as costly or as shotgun in our approach.

Quantification was recognized several years ago as a potential way for us to start correlating clinical outcomes—or the lack of them—with certain levels of Salmonella. We think there will come a time where people will start to agree that one of the data points you need as part of your risk assessment to make decisions at an industrial level is how much Salmonella is in the original sample. If it’s below a certain level, it may not be considered as risky.

In the future, by combining quantification and serotyping, we believe that we will be able to give manufacturers very accurate readings with all the information needed to make good decisions and good calls about their products.

 

Pork

USDA FSIS Eyes New Salmonella Standards for Raw Pork Products

By Food Safety Tech Staff
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Pork

The USDA Food Safety and Inspection Service (FSIS) is considering new Salmonella performance standards focused on raw pork products, due to concerns about recent Salmonella outbreaks linked to these products. The concerns were raised in a study, “Temporal Changes in the Proportion of Salmonella Outbreaks Associated with Twelve Broad Commodity Classes in the United States,” published by the FSIS in Epidemiology & Infection.

The study examined changes in the proportion of foodborne Salmonella outbreaks attributed to 12 commodity groups between 1998 and 2017. Amongst the 12 commodity groups, only pork demonstrated a significant increasing trend—between 1998 and 2017, the estimated proportion of Salmonella outbreaks attributable to pork increased from 4% to 18%—while the proportion of outbreaks for other commodity groups remained essentially unchanged or constant during the 20-year study period.

“Amongst meat and poultry commodities, the consistent and significant increase in the proportion of pork-associated outbreaks is of concern,” noted authors Michael S. Williams and Eric D. Ebel. “Pork ranks as the third most frequently consumed meat commodity in the United States, yet only the chicken and the fruits–nuts commodities are responsible for a larger average proportion of outbreaks in the later years of the dataset. This suggests that the risk of illness per serving from pork may have increased and is high relative to the other meat and poultry commodities.”

The USDA FSIS will be using the results of this study, in addition to public comments on the proposed performance standards for Salmonella on pork products, to inform the development of new policies targeted to reduce Salmonella illnesses attributable to pork.