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USDA FSIS Releases 2023 Foodborne Illness Outbreak Report

By Food Safety Tech Staff
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The USDA Food Safety and Inspection Services (FSIS) has released a summary of outbreaks investigated during FY 2023.

In 2023, FSIS investigated six outbreaks in coordination with local, state, and federal public health partners. These outbreaks involved more than 100 illnesses and 30 hospitalizations. The Centers for Disease Control and Prevention (CDC) notified FSIS of five (83%) of these outbreaks. FSIS became aware of the sixth outbreak by notification from a state public health agency. Five (83%) outbreaks involved illnesses in more than one state.

Of the six outbreaks investigated by FSIS in FY 2023, three were caused by Salmonella (serotypes Newport, Saintpaul, and Typhimurium) and two by STEC (serogroup O157:H7). The sixth investigation involved a report of botulism that included commercially canned potted meat (containing chicken and pork) as a potential source. FSIS’ investigation of the establishment where the canned potted meat was produced, and laboratory testing of similar cans, did not determine that the canned potted meat was the source of the illness. The illness was later determined to not be associated with a food source.

Beef products, including beef ground and packaged at retail stores, were the food product of interest for the five Salmonella and STEC outbreaks investigated in FY 2023. The 2023 outbreak investigations did not lead to any recalls of FSIS-regulated products or public health alerts (PHAs).

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FDA Issues Guidance on Premarket Engagement for Foods Derived from Genome-Edited Plants

By Food Safety Tech Staff
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The FDA has issued a new guidance for industry that describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants. The guidance reaffirms that the risk-based approach the FDA has taken for foods derived from new plant varieties also applies to foods from genome-edited plants. In addition, the guidance describes two processes through which companies may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties. These include voluntary premarket consultations and voluntary premarket meetings. These processes are designed to help ease the pathway to market for foods from genome-edited plants, while keeping FDA safeguards in place.

The voluntary premarket meeting pathway is recommended for developers to inform the agency of their foods when a voluntary premarket consultation is not warranted based on the food’s risk-based characteristics. The agency expects this voluntary premarket meeting pathway to take less time than a voluntary premarket consultation. The FDA continues to suggest voluntary premarket consultations for foods that have certain risk-based characteristics, which are described in the guidance and include:

  • Modifications to endogenous genes that create significant homology to a known allergen that is relevant to human health or a toxin that is relevant to human or animal health.
  • Modifications that cause a non-negligible increase in levels of potentially harmful components, including toxicants, allergens, anti-nutrients, and other components that can exhibit non-nutritive physiological effects on humans or animals.
  • Modifications that cause a non-negligible change in the nutritional value (level of nutrient and/or bioavailability) of the food.
  • Modifications that result in the food containing, at a nutritionally meaningful level, a nutrient found at negligible levels in food from its traditional counterpart.
  • Modifications that result in nutritionally meaningful reductions to the levels of nutrients.
  • Modifications that result in increases to the levels of nutrients such that a safety concern may be raised.
  • Modifications that introduce nutrients to the food that are limited by regulation in similarly used foods.
  • Modifications intended to change the fatty acid profile of the food.
  • Modifications expected to affect the bioavailability of nutrients in the food.

A key purpose of the new guidance is to clarify how FDA’s policy statement “Statement of Policy: Foods Derived from New Plant Varieties” (NPV policy) applies to foods derived from new plant varieties produced using genome editing. The NPV policy provides scientific and regulatory guidance on foods from new plant varieties and lays out broad, risk-based principles for ensuring the safety of foods from new plant varieties. The guidance explains that the principles outlined in the NPV policy apply to foods from genome-edited plant varieties.

The guidance also reminds developers of new plant varieties of their obligations under section 403(w) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was enacted after the issuance of the NPV policy.

Download the Guidance here.

 

Red Apple

Nano-encapsulated Wax Coatings Protect Produce from Pathogens

By Food Safety Tech Staff
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Researchers from Texas A&M have developed a wax coating with nano-encapsulated essential oils for use on produce that provides both immediate and delayed antibacterial effects. Mustafa Akbulut, professor of chemical engineering, worked with horticultural science professor Luis Cisneros-Zevallos to engineer a nano-encapsulated cinnamon-bark essential oil that was then imbibed into a food-grade wax commonly applied on produce surfaces.

They tested the coating on red apples and compared it to traditional wax coatings. Results, published in Current Research in Food Science (vol. 8, 2024), showed that the wax coating with the encapsulated essential oil produced a significant reduction in viable bacterial counts compared to controls coated with paraffin wax after 24 hours of exposure, with reductions of 1.8 ± 0.4 log10 CFU/mL (PBS) and 3.5 ± 0.3 log10 CFU/mL (TSB) for S. aureus, and 1.2 ± 0.2 log10 CFU/mL (PBS) and 1.4 ± 0.4 log10 CFU/mL (TSB) for E. coli.

The nano-encapsulated essential oil made it harder for bacteria to attach and survive on fruits or vegetables. The delayed release of the essential oil increased the half-life of active ingredients and produce compared to its unencapsulated counterparts, according to the study.

The antibacterial effect persisted even after 72-hour immersion in water followed by bacterial exposure. “Furthermore, our novel coatings exhibited significantly reduced bacterial attachment compared to pristine wax-coated substrates. The coatings also showed a great aversion toward A. flavus with the initial zone of inhibition measuring 13.5 ± 0.15 mm and no hyphae and conidiophores growth on the substrates (with coatings) even after 10 days,” the authors wrote.

“This coating was also inhibiting the fungal attachment,” said doctoral student Yashwanth Arcot who ran experiments to support the research. “We have tested this system against Aspergillus, a fungus responsible for the spoilage of food commodities and the onset of lung infections in humans. We were successful in preventing its growth on the hybrid coatings, and these hybrid wax coatings are easily scalable and can be implemented in food processing industries.”

 

James Walter

James Walter Appointed Neogen Vice President of Global Operations

By Food Safety Tech Staff
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James Walter

Neogen Corporation has appointed James “Jim” Walter to the position of Vice President, Global Operations. In this role, he will lead and manage Neogen’s global manufacturing and logistics functions.

Walter graduated with honors from the U.S. Naval Academy with a degree in mathematics and engineering, then served in the Navy as a nuclear engineer. He comes to Neogen after having spent most of his career at Mallinckrodt Pharmaceuticals, serving most recently as Executive Director of Manufacturing Excellence. Previously at Mallinckrodt, he worked in various operations disciplines, helping to execute a wide range of initiatives to drive operational improvement and integration activities, and support growth initiatives. Prior to joining Mallinckrodt, Walter worked in the clean energy industry as Senior Vice President of Operations and Engineering at Tinuum and Vice President of Operations at Catalent Pharma Solutions, where he helped to stabilize and grow the company’s oral and specialty delivery operations worldwide.

“We are excited to welcome Jim to Neogen and add his wealth of operational knowledge to our global leadership team,” said John Adent, President and CEO, Neogen. “Jim brings a great deal of operations and supply chain excellence experience to the company, which will be a significant asset for us, particularly as we continue to integrate the former 3M Food Safety Division into our business.”

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Registration Open for the 2024 Food Safety Consortium

By Food Safety Tech Staff
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Registration for the 12th Annual Food Safety Consortium, which will take place October 20-22, 2024, at the Crystal Gateway Marriott in Arlington, Virginia, directly across the Potomac River from Washington, DC, is now open.

Presented by Food Safety Tech, the Program starts with several pre-conference workshops and training which leads into two full days of high-level panel discussions, educational presentations, and networking opportunities.

Registration options are available for in-person and virtual attendance.

The Consortium will begin with a keynote presentation from James “Jim” Jones, FDA Deputy Commissioner for Human Foods, followed by a Town Hall with Jones and USDA regulators.

Other agenda highlights include:

Navigating Global Food Systems: Insights and Strategies for Compliance with FDA’s Food Traceability Rule
Panelists: Sara Bratager, Sr. Food Safety and Traceability Scientist at IFT; John Crabill, Director of Food Safety & Quality at Chipotle; Adam Friedlander, Policy Analyst, Coordinated Outbeak Response, FDA; and Julie McGill, VP of Supply Chain Strategy and Insight, Trustwell

Food Allergen Controls and the Need for Advisory Labels
Presenter: Dr. Steven Gendel, Gendel Food Safety

Understanding Corrective Actions, Nonconformities and Root Cause Analysis
Presenter: Heather McLemore, Senior Accreditation Officer, A2LA

The Internal Audit: Going Beyond the Certificate
Presenter: Cameron Prince, Executive VP, Regulatory Affairs, The Acheson Group

Using a Food Safety Culture “GPS” to Determine Where You Are and Where You Need to Go
Panelists: Tia Glave and Jill Stuber, Catalyst; Cameron Prince and Benjamin Miller, The Acheson Group

View the full agenda here.

Event Hours

Sunday, October 20: 8:30 am – 5:00 pm (Pre-conference Workshops)

Monday, October 21: 8:00 am – 6:30 pm

Tuesday, October 22: 8:30 am – 3:45 pm

Register now.

For sponsorship and exhibit inquiries, contact RJ Palermo, Director of Sales.

 

Bill Marler

Marler Clark Launches Investigation into Deadly Listeria Cheese Outbreak

By Food Safety Tech Staff
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Bill Marler

Marler Clark, Inc., The Food Safety Law Firm, is investigating the Rizo Lopez Foods cheese Listeria outbreak that has sickened 26 people in 11 states, including deaths in California and Texas.

According to the CDC and FDA, as of February 12, 2024, a total of 26 people infected with the outbreak strain of Listeria have been reported from 11 states, including Arizona, California, Colorado, Florida, Georgia, Nevada, North Carolina, Oregon, Tennessee, Texas, and Washington. Two deaths have been reported, one from California and one from Texas. The FDA and CDC, in collaboration with state and local partners, have linked this multi-year, multistate outbreak of Listeria monocytogenes infections linked to queso fresco and cotija cheeses manufactured by Rizo Lopez Foods, Inc., of Modesto, California. This outbreak includes cases dating back to 2014 and is currently ongoing. CDC investigated this outbreak in 2017 and 2021.

A sample of Rizo Bros Aged Cotija tested positive for Listeria monocytogenes during sampling conducted by the Hawaii State Department of Health’s Food and Drug Branch in January 2024. In response to that finding, Rizo Lopez Foods voluntarily recalled one batch of Rizo Bros Aged Cotija Mexican Grating Cheese (8oz) on January 11, 2024. CDC and FDA reopened the investigation in January 2024 after new illnesses were reported in December 2023 and whole genome sequencing (WGS) analysis of the cotija cheese sample showed that it is the same strain of Listeria that is causing illnesses in this outbreak. FDA initiated an on-site inspection at Rizo Lopez Foods. FDA’s inspection is still ongoing; however, an environmental sample collected during that inspection tested positive for Listeria monocytogenes. WGS analysis of that sample showed that it is the same strain of Listeria that is causing illnesses in this outbreak.

In response to this investigation, Rizo Lopez Foods has recalled all sell by dates of its dairy products. The recalled products include cheese, yogurt, and sour cream sold under the brand names Bright Farms, Campesino, Casa Cardenas, Dole, Don Francisco, Don Pancho, Dos Ranchitos, El Huache, Food City, Fresh Express, H-E-B, La Ordena, Marketside, President’s Choice, Ready Pac Bistro, Rio Grande, Rizo Bros, Rojos, San Carlos, Santa Maria, Tio Francisco, Trader Joe’s, and 365 Whole Foods Market. The firm has temporarily ceased the production and distribution of these products.

In addition, the USDA has issued a public health alert for meat and poultry products containing Rizo Lopes Foods dairy products that may be contaminated.

“In the U.S. there are an estimated 255 deaths due to Listeria monocytogenes every year, and a case fatality rate of 15-30%. Due to the fatality rate and severe complications, Listeria is a pathogen of significant public health concern,” said William Marler of Marler Clark. “Companies that manufacture high risk foods need to do a far better job at eliminating the risk of a resident Listeria bacteria.”

In 2011, Marler Clark represented the families of 33 people who died after consuming Listeria tainted cantaloupe. In 2023, Marler Clark was profiled in the Netflix documentary “Poisoned.”

Image: William “Bill” Marler

Seafood

FDA Issues Draft Guidance on Sampling for Seafood Subject to DWPE

By Food Safety Tech Staff
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The U.S. Food and Drug Administration (FDA) has issued a draft guidance for industry titled “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE.” The draft guidance provides recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE) under an Import Alert because of the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition.

The draft guidance, once finalized, will help foreign manufacturers and other processors of seafood products subject to DWPE submit evidence to the FDA to support a request to have their products removed from DWPE. It also addresses the concern that industry may experience challenges in supporting their arguments about the safety of seafood products subject to DWPE.

Per the draft guidance, foreign manufacturers or other interested parties requesting removal of product from DWPE should provide information to FDA to adequately demonstrate that the conditions that gave rise to the appearance of the violation have been resolved. This may include evidence of a root cause analysis, relevant corrections to the manufacturing process, and/or other controls that have been implemented to address the violation, and hazard analysis critical control point (HACCP) documents, in addition to testing results for consecutive non-violative shipments.

The number of consecutive non-violative shipments required is guided by the FDA’s Regulatory Procedures Manual (RPM), Chapter 9, Sections 9-8-15 and 9-8-16. Typically, five to 12 shipments help demonstrate that the conditions that gave rise to the appearance of the violation have been resolved, per the FDA.

The testing submitted should be from a statistically robust number of samples based on the size of the article and representative of the affected article. The draft guidance includes recommended analytical methods for testing, as well as sampling schedule recommendations with the amount (by weight) of product recommended for collection to represent each sample unit.

Download the draft guidance here.

Stakeholders can submit comments on the draft guidance by April 12, 2024, using docket number FDA-2023-D-5303.

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FDA Identifies Suspect in Lead Contamination Investigation

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On Tuesday, the FDA announced a suspect in the WanaBana cinnamon-applesauce pouch contamination investigation. Per the FDA, Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador, the processor of the ground cinnamon supplied by Negasmart to Austrofoods and later used in recalled apple cinnamon products, is the likely source of contamination. According to ARCSA, the unprocessed cinnamon sticks used in recalled products were sourced from Sri Lanka and were sampled by ARCSA and found to have no lead contamination. ARCSA’s investigation and legal proceedings to determine ultimate responsibility for the contamination are still ongoing.

The FDA noted that it has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera.

As of February 2, there were 100 confirmed cases of lead poisoning, 277 probable cases and 36 suspected cases of for a total of 413 cases from 43 different states. As of February 5, 2024, no additional cases had been reported, and the FDA stated that it has no indication that this issue extends beyond these recalled products nor has it received any confirmed reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon. Confirmed complainants, or people for whom a complaint or adverse event was submitted and met FDA’s complainant definition, are between zero and 53 years of age and the median age is one year old.

CDC’s National Center for Environmental Health is conducting case finding efforts in collaboration with state and local health departments. CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within three months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after November 2022.

 

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FDA Withdraws Guidance on Enforcement of Human Food with Chlorpyrifos Residues

By Food Safety Tech Staff
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The FDA is withdrawing a 2022 guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry, following a decision by the U.S. Court of Appeals for the Eighth Circuit to vacate, or void, an Environmental Protection Agency (EPA) final rule that revoked all tolerances for the pesticide chemical chlorpyrifos.

In April 2021, the U.S. Court of Appeals for the Ninth Circuit ordered EPA to issue a final rule either revoking all chlorpyrifos tolerances or modifying the chlorpyrifos tolerances, provided EPA could make a determination that those modified tolerances met the safety standard mandated by the Federal Food, Drug, and Cosmetic Act (FFDCA). As a result of the short timeframe, EPA found that, based on the available data and anticipated exposure from registered uses of chlorpyrifos, it could not determine that there was a reasonable certainty of no harm from aggregate exposure, including food, drinking water and residential exposure. Consequently, on August 30, 2021 EPA issued a final rule amending 40 CFR 180.342 to revoke all tolerances for residues of chlorpyrifos.

Gharda Chemicals and several grower groups challenged EPA’s revocation of the tolerances in the U.S. Court of Appeals for the Eighth Circuit. On November 2, 2023, the Eighth Circuit issued its decision, vacating EPA’s final rule and remanding the matter to EPA for further proceedings. As a result of this ruling, EPA issued the final rule to reinstate previous tolerances for chlorpyrifos; 40 CFR 180.342 reflects the current legal status of the tolerances for chlorpyrifos. The FDA guidance was intended to explain the agency’s enforcement policy for foods containing chlorpyrifos residues after the tolerances expired, per the 2021 final rule, which is now void.

 

 

 

 

 

 

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FDA Releases Foods Program Priorities

By Food Safety Tech Staff
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The FDA has launched a new webpage listing food-related regulations that it plans to publish by October 2024 as well as longer-term regulations it is prioritizing for publication at a later date. The list includes 22 Foods Program regulations ranging from Certifications Concerning Imported Foods to Nutrient Content Claims and Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation.

The three long-term action items relate to color and food additives.

The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024 to include five new guidances. They include:

  • Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry
  • Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry
  • The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry
  • Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry

Public comments on the list of guidance topics can be submitted to www.regulations.gov using Docket ID FDA-2022-D-2088.