President Biden plans to nominate former FDA Commissioner Robert Califf, M.D. to lead the agency once again—in an announcement mainly focused on clinical trials, vaccine approvals, and ending the coronavirus pandemic. Califf briefly served as FDA commissioner in 2016. His tenure was less than a year.
Perhaps more significant news for the food industry is the President’s intent to nominate Jose Emilio Esteban, Ph.D. to the post of undersecretary for food safety at the USDA. Esteban is currently the chief scientist for FSIS and has been in this role since 2018; he has served in the USDA’s FSIS since 2006. Before his time at the agency, he worked for the CDC.
Online grocery shopping became essential during the early months of the COVID-19 pandemic. While many consumers have returned to the brick and mortar stores, many others have completely changed how they shop for food, opting for online shopping, whether out of convenience or for safety. The FDA has seen and recognizes this shift and even held a three-day virtual summit last month, “The FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers”, to discuss and gain insights into the world of business to consumer e-commerce involving food.
“It is now clear that this is not a trend that will be completely reversed in time but one likely to lead to a new normal in how consumers shop for food, whether it’s from restaurants, grocery stores, or companies providing meal kits and other products,” state Frank Yiannas, deputy commissioner for food policy and response at FDA and Andreas Keller, director, multi-commodity foods, Office of Food Safety at CFSAN on the FDA Voices blog. “Thus, the U.S. Food and Drug Administration is actively working with partners in federal, state, and local government and industry in the U.S. and other nations, as well as with consumer advocates, to help ensure that consumers aren’t ever unwittingly trading food safety for convenience.”
During last month’s meeting, many challenges and questions came up, from how to further prevent food tampering to labeling issues, especially related to allergens, to ensuring that food safety values are shared across all parties involved in producing, transporting and selling food in the e-commerce setting.
FDA announced that it will be reviewing and assessing the information it received during the meeting and is inviting industry to submit public comments now through November 20, 2021 (Docket FDA-2021-N-0929). From there, the agency will determine the critical issues that need to be addressed first.
The daily recordings of the virtual summit are available on FDA’s website.
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, a Food Safety Tech advertiser. Image Credit: Susanne Kuehne
Food fraud has become such an important issue that many governments are monitoring it much more closely. To keep producers and consumers informed on the latest developments, the FDA has generated a new web page on economically motivated adulteration (EMA). The page includes links on how to report food fraud (including a list of consumer complaint coordinators), important examples of adulteration (i.e., honey, olive oil and seafood), how food fraud is detected and monitored, enforcement and legal consequences such as recalls, seizures and import refusals, guidance documents to assist manufacturers and importers, and a list of import alerts.
Dole Fresh Vegetables, Inc. issued a voluntary recall of certain cases of its garden salad over concern of possible Listeria monocytogenes contamination. Although no illnesses have been reported, the company is pulling select lots of its garden salads marketed under the Dole, Marketside, Kroger and Salad Classics names.
The recall was taken as a precaution after a single sample of garden salad tested positive for Listeria monocytogenes in random sampling conducted by the Department of Agriculture in Georgia.
The company announcement states that the product is beyond its “best if used by” date and should no longer be on store shelves. The products were distributed in Alabama, Florida, Georgia, Louisiana, Massachusetts, Maryland, North Carolina, Pennsylvania, South Carolina and Virginia.
As part of its efforts to prioritize the safety of leafy greens, the FDA released the results of a sampling assignment involving testing romaine lettuce from commercial coolers in Yuma County, Arizona. Earlier this year the agency announced that it would be collecting samples of romaine lettuceas part of ongoing surveillance following the spring 2018 multistate outbreak of E.coli O157:H7.
The lettuce was tested for Shiga toxin-producing Escherichia coli (STEC), specifically enterohemorrhagic Escherichia coli (EHEC), and Salmonella spp. The FDA collected 504 romaine samples, and an independent lab conducted the testing.
E.coli O130:H11 was found in one sample, and as a result, the FDA conducted an investigation at the farm to find potential sources and routes of contamination—samples of soil, water, sediment and animal fecal material were taken, and the agency also looked at farm equipment and other surfaces. Out of 24 samples, just one came back positive for STEC, and this sample was taken from the outer leaves of the lettuce. It was determined that the strain was low risk to human health, and FDA did not find that this strain was linked to any past known foodborne illness outbreaks.
“The agency’s goal in conducting this assignment was to determine whether the target pathogens and specific strains may be present in romaine lettuce from the Yuma agricultural region, to help prevent foodborne illness when possible,” FDA stated in a constituent update. “If product that tested positive for EHEC or Salmonella was found, the Agency planned to work with industry and state regulatory partners to identify the cause (e.g., farm follow-up investigation) to inform future regulatory and/or research efforts and to develop strategies that could help preventive additional outbreaks.”
Taking a step further in prioritizing technology and data modernization efforts, today the FDA announced the launch of a new Office of Digital Transformation. The office realigns the agency’s information technology, data management and cybersecurity roles into a central office that reports directly to the FDA commissioner. The reorganization will also help FDA further streamline its data and IT management processes, reducing duplication of processes, and promote best practices, technological efficiencies and shared services in a strategic and secure way.
“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said Acting FDA Commissioner Janet Woodcock, M.D., in an FDA news release. “The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do. By prioritizing data and information stewardship throughout all of our operations, the American public is better assured of the safety of the nation’s food, drugs, medical devices and other products that the FDA regulates in this complex world. This reorganization strengthens our commitment to protecting and promoting public health by improving our regulatory processes with a solid data foundation built in at every level.”
Back in May, FDA launched a technology traceability challenge with the goal of promoting innovation in the development of scalable and affordable traceability technology tools for food operations of all sizes. Today, the agency announced the winning teams and their technologies:
FarmTabs. Free, downloadable software run on Microsoft Excel to aid small and mid-size farmers manage records for traceability/ farm-related metrics.
Freshly. Traceability and batch-tracking software for small businesses (including retailers, manufacturers and distributors).
HeavyConnect. Cloud-based digital traceability and compliance documentation solutions, including a mobile app for producers to capture data in the field and share it across the supply chain.
ItemChain. Item-level traceability to each party in the supply chain.
Kezzler. Solution uses self-service portals to generate item-level identifiers and associate homogenized datasets at the grower level through mobile applications.
Mojix. Uses industry standards to link traceability events for each item or lot throughout the supply chain in an open data network.
OpsSmart. Cloud-based traceability software solution for food safety, recall management, and traceability in a complex supply chain.
Precise’s. Traceability Suite that provides end-to-end supply chain tracking to all segments of the food market, using geospatial, machine learning and IoT technologies.
Roambee/GSM/Wiliot’s. Solution uses low-cost IoT sensor tags in with shipment visibility and verification technologies for end-to-end traceability.
Rfider. Software-as-a-service that captures, secures and shares critical event data along supply chains to consumers.
TagOne. A role-based data capture framework that updates an open source blockchain platform, and uses industry standards to ensure interoperability, and ease of use and data security.
Wholechain. Supply chain traceability system that uses blockchain technology to trace products back to the original source.
For the 23rd quarter in a row, undeclared allergens were the top cause of food recalls and accounted for 45% of them in Q3 2021, according to Sedgwick’s latest Recall Index report. Within allergens, undeclared milk was the leading cause and prepared foods remained the leading category.
“Companies need to concentrate on the basics through the second half of 2021 and final emergence from the COVID-19 pandemic,” the report states. “Amid supply chain pressures, high consumer demand and worker health and safety concerns arising from the coronavirus, food businesses are rightfully focused on their ability to maintain and conduct their core operations in safe manner while delivering quality, safe products to customers.”
FDA Recalls: Notable Numbers (Q2 2021)
106 recalls affecting 7.9 million units
5.8 million units (nearly 69%) impacted by recalls were due to one nut recall
19 recalls were a result of quality issues
18 recalls were a result of foreign material contamination
11 recalls were a result of bacterial contamination—6 from Listeria; 4 Salmonella; and 1 E. coli
USDA Recalls: Notable Numbers (Q2 2021)
Recalls increased from 10 (Q1) to 12, but numbers still low compared to 2019 quarterly averages
Units impacted dramatically dropped nearly 83% to 207,322 units
Undeclared allergens were top cause of recalls, accounting for nearly 42%
Soy milk and eggs were main allergens, but first recall of food products due to sesame also occurred
Other recall reasons were quality (2), lack of inspection (2), bacterial contamination (2) and foreign material contamination (1)
Beef products (93,551 pounds) most impacted category, followed by fish (46,804 pounds)
The report also pointed out that heavy metal regulation will have increased emphasis, as FDA has made it a priority as a result of a report released by Congress earlier this year indicating the presence of dangerous toxic heavy metals found in baby foods.
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.
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.
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.
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.
McCormick & Company, Inc. has initiated a voluntary recall of its McCormick Perfect Pinch Italian Seasoning, McCormick Culinary Italian Seasoning and Frank’s RedHot Buffalo Ranch Seasoning over concerns of Salmonella contamination. FDA uncovered the issue during routine testing.
The recalled products were shipped nationwide, as well as to Bermuda and Canada. between June 20 and July 21, 2021.
Thus far there have been no reports of illnesses related to this issue. McCormick has alerted customers and grocery retailers to remove and discard the product.
Food safety experts will discuss challenges and tangible best practices in Salmonella detection, mitigation and control, along with critical issues that the food industry faces with regards to the pathogen. This includes the journey and progress of petition to USDA on reforming and modernizing poultry inspections to reduce the incidence of Salmonella and Campylobacter; Salmonella detection, mitigation and control; and a case study on the pathogen involving crisis management.
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