Tag Archives: FDA

Salmonella Surveillance

Mid-Year Pathogen Surveillance and Inspection Update

By Nathan Libbey
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Salmonella Surveillance

Food Recalls

The first half of 2021 saw almost a 20% increase in recalls vs. the last 6 months of 2020 (117 vs. 96). According to a recent report by Lathrop GPM, LLC, food producers have seen an increase in food safety incidents since the pandemic began, and expect an ongoing increase over the next year.1 A majority of recalls were due to undeclared allergens or potential for allergen cross contamination. Second to allergens were potential for microbiological contaminants, including Salmonella, Listeria, E. coli, and Cyclospora.

FDA Recalls Recalls
Figure 1 and 2. The first half of 2021 saw a 26% increase of facility inspections by the FDA. Despite this jump, inspections in the first half of 2020 were 80% higher than this year’s first six months. Source: FDA Recalls, Market Withdrawals, & Safety Alerts.

Inspection Results

The first half of 2021 saw a 26% increase of facility inspections by the FDA. Despite this jump, inspections in the first half of 2020 were 80% higher than this year’s first six months. Inspections generally lead to three outcomes; No Action Indicated (continue as you were,) Voluntary Action Indicated (voluntary to make some changes), or Official Action Indicated (OAI) (Regulatory Actions will be recommended by the FDA). A majority of inspections (56%) resulted in NAI this year, compared to 59% and 50% in the first and second halves of 2020, respectively.

Facility Inspections
Figure 3. Facility Inspections. Data from FDA.

Salmonella Surveillance

The FSIS provides ongoing surveillance of Salmonella and Campylobacter presence in poultry, both domestic and imported. Salmonella is reported by facility and each is given a category rating of 1–3. One is exceeding the standard (based on a 52-week moving average), two is meeting the standard, and three is below standard. For the 52-week reporting period ending May 30, 2021, 60% achieved category one, compared to 56% the previous 52 weeks.

Salmonella Surveillance Salmonella Surveillance
Figures 4 & 5. Salmonella surveillance data from FDA.

Listeria and Salmonella Surveillance in RTE Meat and Poultry

USDA FSIS conducts periodic sampling of Ready to Eat (RTE) meat and poultry products and reports quarterly results. Sampling is conducted both in a random fashion as well as based on risk-based sampling. In Q2 2021, 4769 samples were tested for Listeria, compared to 4632 in Q1.

Percent positive rates were .36% for Q2 and .43% for Q1. Neither quarter reported any positives for Listeria in imported RTE Meat and Poultry Products.

Salmonella samples for RTE totaled 3676 in Q2 2021, compared with 3566 in Q1. In both quarters, only 1 positive was found in the samples collected.

Routine Beef Sampling for E. coli 0157:H7 and STEC

The FSIS also conducts ongoing routine sampling of beef products for E. coli. E. coli is further classified into 0157:H7 and non-0157:H7 Shiga toxin-producing E. coli (STEC). In Q2 of 2021, 4467 samples were collected and tested for 0157:H7 versus 4268 in Q1. Of these, three were positive, compared to seven positives the preceding quarter. For STEC, a total of 8 positives were found, compared to 1 positive in Q1. No positives were found in imported goods in Q2, although in Q1 2021, 4 positives for STEC were found.

Conclusion

The first half of 2021 showed an increase in activity, which is on par with food industry survey data. Food recalls have increased, with food allergens remaining the most prevalent reason for recall or withdrawal. While inspections also increased, they have not returned to pre-pandemic levels. The impact of the spread of the Delta variant and increased restrictions is yet to be seen, but inspection activity will likely not rebound entirely by the end of the year. Pathogen tests by FSIS increased quarter over quarter for Salmonella, E. coli, and STEC, with mixed results in prevalence.

Reference

1. Lathrop GPM, LLC. (2021). Food Processing Trends, Outlook and Guidance Report. Retrieved from https://www.lathropgpm.com/report-agribusiness.html

Recall

McCormick & Company Initiates Voluntary Recall of Italian Seasoning Products and Frank’s RedHot Buffalo Ranch Seasoning

By Food Safety Tech Staff
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Recall

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.

Attend the On-Demand Virtual Event:

Food Safety Hazards Series: Salmonella Detection, Mitigation, Control and Regulation

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.

Nathan Libbey, PathogenDx
FST Soapbox

On the Eve of 115 Years of Food Regulation in the United States

By Nathan Libbey
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Nathan Libbey, PathogenDx

As we look back on the history of food safety in the United States, it is easy to take pride in how far we have come—from disparate, state-specific food laws with no interstate oversight, to highly codified regulations such as FSMA, food and consumer safety has evolved a great deal since the passage of the Pure Food and Drug Act in June of 1906. However, despite our advancements, we see evidence of significant gaps that currently exist and must be addressed to improve safety and save lives moving forward, no different than what occurred in the time leading up to the initial Act.

The 1906 Act

Revisionist history will tell us that the consumers’ outcry due to the publication of Sinclair’s The Jungle, coupled with Roosevelt’s disgust after reading the novel, is what ultimately led to the passage of the Act. What has not changed in 115 years is that one book does not yield the power to force the hand of what is largely a deadlocked U.S. Legislature. What moves us from an emotional standpoint often does not translate into real change, and the Pure Food and Drug Act was no exception.

By many accounts the largest proponent of the Act, sometimes referred to as the Wiley Act, was Harvey Wiley, son of an Indiana preacher and former professor at Purdue University. Wiley spent much of his time at Purdue studying the chemistry of sugar and was particularly interested in sugar and other foods’ adulteration. He took on the burden of challenging the food system and improving the safety of consumer products. Wiley is known for his work on “The Poison Squad,” but also was a budding food safety poet:

“We cannot help asking “What’s in it? Oh, maybe this bread contains alum and chalk, Or sawdust chopped up very fine, Or gypsum in powder about which they talk”.1

Despite Wiley’s significant studies and subsequent passion for food safety that he brought to the U.S. Bureau of Chemistry, little was done to advance the status of food safety in the United States. Many bills were attempted, but like today, a bill introduced and backed with fervor in the House did not reach a meaningful Senate vote and vice versa—politics was politics. When McKinley was shot and subsequently died, leaving Theodore Roosevelt to take the helm, Wiley caught the break he needed. Roosevelt had been convinced he had been a victim of the “Embalmed Beef Scandal” while serving in the Spanish American War and had a rather progressive agenda that fit well with Wiley’s evangelization of food safety.2

Flash forward to 1906, Sinclair’s book is published, everyone loses it on the atrocities that exist in food production, including the President. We romanticize that this led to the passing of the Act and future development of what was to become the Food and Drug Administration. In addition to the Act, companion legislation, The Meat Inspection Act of 1906 that would later give rise to the FSIS, was also on the docket for 1906, signaling imminent changes for meat producers. Sure, a role was played by the tale of Jurgis and Elzbieta (the main characters in The Jungle), but more than 25 years of reports and proposed reforms are what lead to significant legislation, and this is the case with the Pure Food and Drug Act—1906 was just the year it all came together.

At the same time, industry had come around. While they had vehemently opposed to earlier iterations of what was deemed over-regulation, they had come to grips with the reality—change was necessary. What their stalling of the bills did, as it does for industries of all makes and models today, is buy them time to adjust. Changes, such as replacing flour laced with sawdust with the real thing, takes changes in processes, personnel, and ultimately money. The industry needed to plan financially prior to enacting and, more importantly, embracing changes. Unlike FSMA, which was rolled out in phases over a decade, early legislation was far less comprehensive and did not account for the impact on firms of various sizes.

Implications for Today

Back to the original points, look how far we have come. Sure, the political landscape is seemingly murky, but it has been for centuries. What binds us all together, and ultimately moves us forward is our collective effort toward continuous improvement. In the spirit of Harvey Wiley, we strive to move forward as lawmakers, food producers and consumers. An unhealthy consumer is indeed bad for business for us all. As was stated during the arguments in the Senate in 1906 by Senator Porter McCumber:

“We are coming more and more to understand that our health depends more upon the character of food we consume than upon the medicines that are given to allay and destroy disease. We are coming more and more to understand that a proper diet varied to meet the conditions of each individual is not only the greatest panacea for but also the greatest preventitive [sic] against the evils with which humanity seems to be afflicted.”3

Quotes like this should give us direction—it has been and will be the backdrop of our cause for food safety and overt disease prevention. The same mantras from 1906 that guided our first piece of food safety legislation are still relevant; we need profound, driven, bold thinkers today just as we did then.

What also remains is the fact that we are still largely siloed, we have macro-level deficiencies as a result of our micro-level programs. An example of our delay, that is the public need is outpacing our industry standards, is our unwillingness to share food safety data. Traceability initiatives and FDA guidance are moving this forward, but the implications will not be felt overnight, just as Sinclair’s book did not change policy overnight. Another area where our lack of system and big-picture thinking impacts our consumers negatively is with the myriad versions, some dating back to 2000 (MS-DOS, anyone?), of Food Code that are adopted by our individual States for retail and foodservice settings. Lastly, the existence of food desserts and larger issue of food insecurity is a macro issue that we deal with (or ignore) on a micro level.

As it was during the stalemate legislative sessions around the turn of the 20th century, it takes all stakeholders to move the status quo forward, not just those with the end vote. Consumers, regulators, and industry must remember our collective drivers and be willing to share best practices, propel continuous improvement, and, yes, accept increased regulation in order to move the bar forward if necessary. 115 years post-Pure Food and Drug Act, we have evolved, 10 years post-FSMA, we have evolved, but we must increase our rate of evolution. We have tremendous, untapped capacity to create significant change and save lives during the technologically advanced, partisan, hyper-politicized, woke, lit, insert adjective here decade that is and will be the roaring 20s v2.0—let’s be sure to take advantage of it.

References

  1. Stirling, DA. (2002). Harvey W. Wiley. Toxicological Sciences, 67(2), 157-158.
  2. Keuchel, E F. (1974). Chemicals and meat: the embalmed beef scandal of the Spanish-American war. Bulletin of the History of Medicine, 48(2), 249-264.
  3. Barkan, I. D. (1985). Industry invites regulation: The Passage of the pure food and drug act of 1906. American Journal of Public Health (1971), 75(1), 18-26.
Chris Keith, FlexXray
FST Soapbox

How Foreign Material Inspection Can Impact Your Liability From Packaging

By Chris Keith
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Chris Keith, FlexXray

Packaging is an essential component of our modern, global food supply. While it helps us preserve and protect food and creates instant brand recognition for consumers, packaging also inserts an additional level of necessary risk mitigation into the manufacturing process. Liability stemming from packaging is a serious concern for food manufacturers of all sizes, with millions of dollars and brand-damaging lawsuits on the line. Processed foods need packaging to arrive in the hands of consumers, and processed foods are necessary to feed the world’s population. According to a survey conducted by the United States National Library of Medicine, “60% of calories consumed were from ultra-processed foods.”1 This shows the prevalence of processed foods and the significant impact packaging, a ubiquitous component of processed foods, plays in the food industry.1 However, if not handled properly, food packaging can be a significant liability.

Liability from packaging commonly presents in two ways: First, as foreign material contamination. Broken, damaged or defective packaging material can end up in food products, which increases the risk of a consumer attempting to consume contaminated goods. Second, packaging can be a hurdle to effective remediation of foreign material contamination, as goods can often not be efficiently or effectively inspected back through in-plant critical control points. The resulting disposal of product can contribute to food and environmental waste, as well as lost profits.

The harsh truth is that if manufacturers lack processes to identify, prevent or mitigate foreign material contamination when it occurs in packaged food, packaging can be a significant liability at every stage from the manufacturing facility to the store shelf. Following strict food safety plans can save countless hours, resources and dollars in the long run.2

Foreign Material Contamination: Where It Comes From

Foreign material contamination comes from multiple sources in the production cycle. It can come from raw materials, like animal bones ending up in boneless meat products. It can happen during the production process when a screw or seal detaches from a machine and gets mixed into a pie. It can be biological, like an insect ending up in a bag of chips. Or it can come from packaging: A shard of glass winding up in a jar of salsa or a plastic wrapper finding itself in a muffin. All of these foreign material contaminants are risks and dangers for which manufacturers can be held liable.

Packaging-related contamination is a high priority for manufacturers. Foreign material contamination due to packaging occurs when contaminants like metal, plastic, styrofoam and other objects end up where they do not belong, disrupting the integrity and quality of the product. Packaging materials can break down into tiny pieces that inline inspection machines may not be able to identify. Inline machines are calibrated for a certain size and certain types of foreign material contamination, which may not include packaging materials. Additionally, inline machines are often used at critical points during the manufacturing process but are not commonly used to inspect completed packaged products.

Break It Down: Liabilities Within Food Packaging

The party most affected by missed foreign material contamination is the consumer. Current consumer trends point to greater ingredient awareness, education and research into the companies from which consumers purchase products. The consumer mindset of environmentally friendly products and socially responsible purchases are impacting the food industry directly. Consumers seek transparency from brands about the products they’re ingesting. When a consumer discovers foreign material contamination inside a product, it creates frustration and eliminates trust. In addition to negatively impacted brand reputation, a foreign object from packaging can be incredibly costly. Recalls, especially those that require a local or national public warning, are detrimental to a brand’s reputation.3 Consumer trust in a brand is priceless and can take years to repair when broken.

In the age of social media, consumer reports of foreign material contamination can spread like wildfire across multiple platforms, reaching countless consumers across the world. One tweet about a contaminated product can go viral, costing corporations their reputations or worse–– lawsuits. An accidental miss somewhere along the production line can result in public outrage and cost the manufacturer millions of dollars in wasted product and crisis management. Suppose a consumer accidentally consumes a foreign contaminant from product packaging which results in injury. In that case, the manufacturer could be held liable for the medical bills and even long-term care if the injury is debilitating. These court cases can be highly costly monetarily and in terms of public perception.

In addition to legal liability from consumers, the loss of product for foreign material contamination is typically very costly when labor, storage, time, materials and lost revenue are taken into account. A producer who makes the moral and ethical decision to dispose of product that may be contaminated loses money doing so. They also risk harming their reputation with consumers by contributing to the problem of food waste.

In the 21st century, shoppers are increasingly looking “beyond the label,” and are concerned with the impact their purchase behaviors have on the environment.4 Consumers in younger demographics are significantly more likely to have a purchase decision influenced by a company’s impact on and concern for the environment. Packaging is a major concern for food manufacturers as they seek to lessen their environmental impact to meet market demands. This impacts foreign material contamination in two important ways. First, as packaging materials move towards the use of biodegradable materials, the capability of technology to detect the difference between packaging and food material must increase. Second, environmentally-friendly packaging is still relatively new compared to traditional materials, and the risks of foreign material contamination associated with these materials are still relatively unknown.

Manufacturers are in a difficult position when dealing with the liabilities stemming from packaging as a foreign material contaminant. Compounding this issue is the role packaging plays in preventing manufacturers from using in-house processes or inline equipment to inspect product back through Critical Control Points. Inline mechanisms for identifying foreign material contamination are not designed to inspect completed, packaged product. If producers dispose of and rework product, they risk harm to sustainability-focused brands, production quotas and bottom lines. If they attempt to identify the contamination themselves, they lose valuable production time and potentially lose perishable product to spoilage. With nearly every solution, another liability arises.

Packaging Contaminants: Prevention, Response and Liability

The FDA-required Hazard Analysis and Critical Control Points (HACCP) plan has seven principles to ensure manufacturers meet food safety goals from production to consumption. Physical, chemical and visual tests are involved to ensure foreign contaminants do not exist in products produced in the manufacturing facilities.5 The more detailed processes are in place, the more protected companies are from recalls and reducing the chance of a lawsuit where the manufacturer is liable. Implementing different programs and processes to prevent and diminish food waste ultimately positively impacts the manufacturer’s bottom line. The Business Case conducted a study called “Reducing Food Loss, and Waste” that found “99% of companies earned a positive investment when they implemented programs to reduce food waste”.6

Many companies engage third-party food inspection partners as an extra measure to ensure that their product is free from foreign material contamination. By electing to utilize third-party inspection services, manufacturers hit a trifecta: They can typically salvage the majority of on-hold product, reduce food waste, and with the right partner, get the data they need to have traceability of foreign material contamination issues at their plant.

Manufacturers should pursue third-party inspection partners that meet a high standard of excellence. The best third-party inspection partners use cutting-edge technology to inspect products in higher detail than inline machines. Their machines should be capable of identifying foreign material contaminants of all types and have a high capacity to turn around large volumes of product efficiently. Their machines should be capable of overcoming the obstacle of packaging as an impediment to inspection using machines with a larger aperture than typical inline tools. Lastly, third-party inspection adds significant value if it has the ability to find and retrieve foreign material contamination so manufacturers can effectively use the resulting data to identify and remediate problems within the plant. An inspection service that does not meet these criteria is not an inspection service, but merely a method for outsourcing the same practices that a manufacturer would conduct in-house.

Liability Questions Answered

So, when are companies liable for packaging issues? Unfortunately, the answer isn’t always black and white. FSMA is in place to help prevent foodborne illness, requiring Food Safety Plans. In addition, the FDA recognizes “that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food,” so manufacturers may not be the only ones liable in many cases.7 The problem arises when manufacturers miss foreign contaminants or if foreign biological contaminants affect the integrity of the packaging.

Even if companies take the necessary steps, incorporate a HACCP plan and are vigilant, contamination can, unfortunately, happen at any time to any manufacturer. Using a third-party partner as an outside resource for foreign material inspection is important. Choosing a third-party partner with the experience, certifications, technology, processes and reputation to protect your brand is critical. Manufacturers can validate their internal processes and data using reports from their third-party inspection partner more quickly than they could internally.

Food packaging and the potential liability involved can be daunting. Still, with proper processes and procedures in place, manufacturers can have confidence that their products are hitting the shelves with a low probability of recall or lawsuit due to a packaging issue. While there is always a chance of foreign material contamination, quality packaging materials, quality assurance processes and quality third-party inspection partners can significantly reduce a company’s potential liability.

References

  1. Baraldi, L. G. (March 9, 2018). “Consumption of ultra-processed foods and associated sociodemographic factors in the USA between 2007 and 2012: evidence from a nationally representative cross-sectional study.” BMJ Open.
  2. FDA. “FSMA Final Rule For Preventive Controls For Human Food”.
  3. Lusk, J. (October 15, 2019). “Consumer Beliefs About Healthy Foods And Diets.”
  4. Cheung, K. H. J. L. (2020). “Meet the 2020 Consumers Driving Change“. IBM.
  5. FDA(August 14, 1997). “HACCP Principles & Application Guidelines.”
  6. Hansen, C. “The Business Case For Reducing Food Loss and Waste.” Champions 12.3.
  7. FDA. “Food Safety Modernization Act (FSMA).”
magnifying glass

FDA’s Traceability Tech Challenges Goes Live

By Food Safety Tech Staff
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magnifying glass

Today FDA launched its latest initiative set forth as part of the New Era of Smarter Food Safety blueprint: The FDA New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge. The agency is asking technology providers, entrepreneurs and innovators to come forward and develop traceability technology tools that are scalable and affordable for food operations of all sizes.

“Too many Americans suffer from foodborne illnesses every year. Making the food supply more digitally enabled and food more traceable will speed the response to outbreaks and deepen our understanding of what causes them and how to prevent them from happening again,” said Acting FDA Commissioner Janet Woodcock, M.D. in an agency release “One of the FDA’s highest priorities is protecting consumers from foodborne illnesses. We hope to find new, innovative ways to encourage firms of all sizes to voluntarily adopt tracing technologies that can help our nation modernize the way we work together to determine possible sources of foodborne illnesses as quickly as possible to keep Americans safe.”

Additional information about the challenge, which ends on July 30, can be found on the precisionFDA website.

Food Safety Consortium Virtual Conference Series

2021 FSC Episode 4 Preview: Food Safety Supply Chain Management

By Food Safety Tech Staff
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Food Safety Consortium Virtual Conference Series

This week’s episode of the 2021 Food Safety Consortium Virtual Conference Series will discuss the challenges that the industry faces in managing the supply chain, including in the realm of audits. The following is the agenda for this Thursday’s session:

  • Food Safety as a Supply Chain Management Problem, with John Spink, Ph.D., Michigan State University
  • Supplier Certification in Today’s Supplier Quality Management Programs: A Discussion with Gary van Breda, McDonald’s; Jorge Hernandez, Wendy’s; and moderated by Kari Hensien, RizePoint; Sponsored by RizePoint
  • What Needs to Change in Food Safety Certification: A GFSI Panel Discussion moderated by Erica Sheward, GFSI
  • Auditing Update in the Age of COVID: FDA Standards and Regulations Alignment Pilot, with Trish Wester, AFSAP

This year’s event occurs as a Spring program and a Fall program. Haven’t registered? Follow this link to the 2021 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! Registration includes access to both the Spring and the Fall events. We look forward to your joining us virtually.

FDA

FDA to Launch Technology Traceability Challenge

By Food Safety Tech Staff
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FDA

The FDA is asking technology providers, entrepreneurs and innovators to come forward and develop traceability technology tools that are scalable and affordable for food operations of all sizes. The FDA New Era of Smarter Food Safety Low or No-Cost Tech-enabled Traceability Challenge will launch on June 1.

“Achieving end-to-end food traceability will involve everyone in the supply chain – from source to table. To achieve that level of participation, we need accessible tracing solutions for human and animal food companies of all sizes. That means that we must help ensure that even small companies can use and benefit from new tracing technologies,” said Frank Yiannas, deputy commissioner for food policy and response at FDA, in an agency blog post. “Digitizing data at no or low cost through the use of creative financial models may allow the entire food system to get smarter together.”

The challenge will be administered by precisionFDA and overseen by the agency’s Office of Food Policy and Response. On June 1 at 8 am ET, the FDA’s pre-registration page will be updated with the submission information. The deadline for the challenge is July 30 at 5 pm ET.

Up to 12 winners will be selected and although there is no cash prize, the winners will have the chance to discuss their technology solution during an FDA public forum. “The food industry will gain new insights into how to solve traceability challenges, and the FDA will open the door to a conversation about finding new ways to overcome obstacles in the road to farm-to-fork traceability,” stated Yiannas.

The challenge is part of the goals outlined in the FDA’s New Era of Smarter Food Safety blueprint, which specifies tech-enabled traceability as a core element.

Food Safety Consortium Virtual Conference Series

2021 FSC Episode 1 Preview: FDA on New Era, Experts Discuss Digital Transformation and Consumer Focus

By Food Safety Tech Staff
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Food Safety Consortium Virtual Conference Series

Thursday, May 6, marks the first episode of the 2021 Food Safety Consortium Virtual Conference Series. The following are highlights for this week’s session:

  • FSMA-Based & Technology-Enabled: FDA Advances into New Era of Smarter Food Safety, a special keynote with Frank Yiannas, FDA
  • Digital Transformation in Food Safety, with Natasa Matyasova and Matt Dofoo, Nestlé
  • Consumer-focused Food Safety, with Mitzi Baum, STOP Foodborne Illness
  • TechTalks from Controlant, Veeva and Primority

This year’s event occurs as a Spring program and a Fall program. Haven’t registered? Follow this link to the 2021 Food Safety Consortium Virtual Conference Series, which provides access to all the episodes featuring critical industry insights from leading subject matter experts! Registration includes access to both the Spring and the Fall events. We look forward to your joining us virtually.

FDA

FDA’s ‘Closer to Zero’ Action Plan to Reduce Exposure to Toxic Elements in Baby Food

By Food Safety Tech Staff
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FDA

Following the report released by Congress in February regarding an alarming amount of toxic heavy metals found in baby food, the FDA has released an action plan that aims to reduce the presence of those dangerous metals to the “lowest possible levels” in common foods consumed by babies and young children. The “Closer to Zero” plan takes research, regulatory and outreach into consideration and will use the following approach:

  • Evaluating the scientific basis for action levels. FDA will evaluate existing data from routine testing of food, research and data on chemical analytical methods, toxicological assays, exposure and risk assessments, and other relevant scientific information.
  • Proposing action levels for specific toxic elements in baby food categories that include cereal, formula, and pureed fruits and vegetables.
  • Working with stakeholders and federal partners on proposed action levels— including collecting data and information from workshops and scientific meetings—and assessing the feasibility of the proposed action levels and timeframes for achieving them. The FDA will use and monitor the information to finalize the action levels.

“Our action plan will start with prioritizing our work on those elements for which we have the most data and information – arsenic and lead – while research continues on other elements, progressing through each element over time across various categories of foods consumed by babies and young children,” stated Janet Woodcock, M.D., acting FDA commissioner and Susan Mayne, Ph.D., director of CFSAN. “During the plan’s first year (phase one), we will be proposing action levels for lead in categories of foods consumed by babies and young children, consulting with and gathering data from stakeholders and federal partners on issues such as the feasibility of meeting action levels for lead, and sharing resources with industry on best practices for reducing or preventing lead contamination. We will also complete updated sampling assignments testing toxic element levels in baby foods and evaluate the science related to arsenic exposure from foods beyond infant rice cereal. Phases two, three and beyond are outlined in our plan.” Phase 2 runs from April 2022 until April 2024 and will expand the agency’s work into cadmium and mercury, as well as finalize action levels for lead. Phase three and beyond begins in April 2024 and will finalize action levels for arsenic.

FDA

FDA Publishes Report on Fall 2020 E. Coli Outbreak in Leafy Greens

By Food Safety Tech Staff
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FDA

Today the FDA released a report on its investigation into the E. coli O157:H7 outbreak involving leafy greens during the Fall 2020. The report also identified three reoccurring trends in the contamination of leafy greens grown in the Central Coast of California related to the outbreak strain, region and issues with activities on adjacent land.

In January, FDA released preliminary findings, which linked cattle feces to the outbreak strain—located uphill from where contaminated leafy greens were grown.

“In the investigation, the FDA recommends that growers of leafy greens in the California Central Coast Growing Region consider this reoccurring E. coli strain a reasonably foreseeable hazard, and specifically of concern in the South Monterey County area of the Salinas Valley,” stated Frank Yiannas, deputy commissioner for food policy and response, in an agency news release. “It is important to note that farms covered by the Food Safety Modernization Act (FSMA) Produce Safety Rule are required to implement science and risk-based preventive measures in the rule, which includes practices that prevent the introduction of known or reasonably foreseeable hazards into or onto produce.”

The 2021 Food Safety Consortium Virtual Conference Series kicks off on May 6 with a keynote address from Frank Yiannas, deputy commissioner of food policy and response at FDA The FDA also recommends that the region’s agricultural community work to determine where the reoccurring strain of the pathogenic E. coli is persisting, along with the probable contamination route(s).

“Although the FDA is keenly focused on taking steps to help mitigate recurring leafy green contamination events, we alone cannot fix this issue. Industry leadership and collaboration among growers, processors, retailers, state partners and the broader agricultural community is critical to reducing foodborne illnesses,” Yiannas stated. “At the FDA, the safety of leafy greens remains a top priority, and we are committed to working with all stakeholders to address this significant public health issue and further protect consumers.”

The Report, “Factors Potentially Contributing to the Contamination of Leafy Greens Implicated in the Fall 2020 Outbreak of E. coli O157:H7”, can be downloaded from FDA’s website.