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The FDA Releases 2022 Cantaloupe Outbreak Investigation Report

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By Ryan Maus

In August 2022, a CDC epidemiological investigation and traceback data identified a multistate cluster of Salmonella Typhimurium illnesses in the upper Midwest indicating melons as a potential source of exposures. The outbreak was traced to cantaloupe and resulted in eighty-seven illnesses and thirty-two hospitalizations across eleven states. The following describes FDA’s investigational findings and provides their recommendations to growers of melons and similar produce.

The FDA utilized traceback data to identify a common packinghouse of suspect cantaloupes associated with the outbreak. However, there was no convergence to a single shipment of products. Three farms in southern Indiana that supplied the common packinghouse were identified as potential sources of cantaloupe. Around the growing locations other commodities were grown such as grain, oilseed, and beans; interspersed with various vegetable crops, including melons; and several poultry feeding operations. Heavy rains had also occurred in the growing region in late July resulting in floods.

Sampling of the packing house, the three farms, and the surrounding lands resulted in numerous findings of Salmonella, but only one of the farms produced an isolate genetically related to the outbreak strain (i.e., having an intermediate level of differences in genomes but not a genetic match). The results suggest that Salmonella presence is a reoccurring issue that may impact the safety of melons grown in this region.

FDA provides the following recommendations/requirements to producers of melons and similar produce.

  • Review current conditions and practices to determine whether they are adequate or if additional
  • prevention measures are warranted.
  • Understand previous land use to identify and address potential sources of pathogens that may
    affect their farming operations.
  • Assess risks that may be posed by adjacent and nearby land uses, especially as it relates to the
    presence of livestock, poultry, and the interface between farmland, and other agricultural areas.
  • Consider additional tools such as pre-harvest and/or post-harvest sampling and testing of
    products to help inform the need for specific prevention measures.
  • Poultry manure, while valued for its fertilizer value, is a known reservoir for Salmonella
    spp. Proper application of a manure that has been treated with a validated and verified process
    to reduce pathogens (e.g., composting with time and temperature measurements) can
    significantly reduce the potential for the integration of Salmonella or other human pathogens into
    soils (as compared to the use of raw manures).
  • Inspect, maintain, and clean and, when necessary and appropriate, sanitize all food contact
    surfaces of equipment and tools used as frequently as necessary to protect against contamination.
  • When appropriate, use EPA-approved products according to the label for cleaning and sanitizing.
  • Inconsistent adherence to or deviation from existing SOPs for cleaning and sanitizing by farms can
    affect produce safety. Effective communication on farms about SOPs and any changes to those
    SOPs can help ensure that food safety practices are being followed.
  • Root cause analyses may be useful in identifying for growers how human pathogen sources in the
    broader agricultural environment may contribute to contamination.
  • Improve traceability through increased digitization, interoperability, and standardization of
    traceability records which would expedite traceback and help remove contaminated product from
    the marketplace more quickly, thereby preventing further illnesses. This is not only important for
    growers, but also critical for shippers, manufactures, and retailers as well, to improve overall
    traceability throughout the supply chain.

FDA’s Updated Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact Provides Useful Information to the Food Industry

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By Laurie Post, Ph.D.

On May 16, 2023, FDA released a draft compliance policy guide (CPG) that provides guidance for FDA staff, including investigators, on FDA’s enforcement policy regarding major food allergen labeling and cross-contact. While FDA guidance documents should be reviewed as recommendations, unless specific regulatory or statutory requirements are cited, these type of communications from the FDA are useful to industry because they present FDA’s current thinking and polices on significant food safety topics. The current draft CPG updates the 2005 CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens. The recent draft CPG provides a more detailed perspective on FDA’s current policies on food allergen labeling requirements, allergen cross-contact, voluntary allergen information (e.g., advisory label statements), thresholds, and regulatory actions. FDA states that their regulatory approach in addressing allergen violations will be case-by-case and dependent on the facts of each situation.

Allergen Cross-Contact and FDA’s Regulatory Approach

Allergen cross-contact is the unintentional incorporation of a food allergen into a food that does not contain that allergen as an ingredient. It is defined in FDA’s rule titled, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” 21 CFR part 117.

Allergen cross-contact may occur due to practices such as failure to adequately clean shared equipment, failure to properly segregate allergens, improper rework addition, or improper production scheduling. The draft CPG notes that the likelihood an allergen will be present due to cross-contact can be impacted by factors such as the characteristics of the food, the distribution of the allergen within a food (homogeneous versus particulate), the type of manufacturing process, the equipment used, and the cleaning procedures applied (e.g., dry cleaning versus wet cleaning).

While FDA acknowledges the factors that lead to allergen cross-contact, the draft CPG also confirms FDA’s position that “major food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the ‘Contains’ statement.” Manufacturers must instead comply with applicable requirements to address the potential for allergen cross-contact through appropriate preventive controls established in 21 CFR Part 117. With a few exceptions, these preventive controls requirements specify that food facilities must implement a food safety plan that includes a hazard analysis to identify known or reasonably foreseeable hazards that require a preventive control and must significantly minimize or prevent allergen hazards so that the food product will not be adulterated (section 402 of the FD&C Act (21 U.S.C. 342(a)) or misbranded (section 403(w) of the FD&C Act (21 U.S.C. 343(w) (21 CFR 117.135).

FDA generally regards a product to be misbranded when case-by-case review of the evidence shows that the product’s label bears incomplete or inconsistent product information regarding major food allergens.

  • The food is formulated to contain a major food allergen as an ingredient and fails to declare on the label the major food allergen in either the ingredient list or the “Contains” statement as required (section 403(w) of the FD&C Act (21 U.S.C. 343(w)).
  • The food is fabricated from two or more ingredients but fails to declare on the label the common or usual name of the ingredient in the ingredient list as required (section 403(i)(2) of the FD&C Act (21 U.S.C. 343(i)(2)).

FDA generally regards a product to be adulterated when a case-by-case review of the evidence, including inspectional evidence or other information, demonstrates that allergen cross-contact may render the product injurious to health (section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)).

  • When there is evidence of inadequate allergen cross-contact controls, FDA may deem a product adulterated even when the product bears an allergen advisory statement.

For example, inadequate sanitation control, such as failure to adequately clean shared equipment between production runs of products with different allergen profiles, may render the product adulterated. As another example, inadequate allergen label controls, such as failure to check the product label to ensure major food allergen ingredients intended to be in the food are labeled as required, may result in a misbranded product.

If testing detects an allergen in food or FDA suspects an allergen is present because of one or more adverse consumer reactions, but the origin of the allergen in the product is not known, FDA may follow up with the company to obtain additional information such as product formulation, ingredient information, and information about other products made on the same line or in the same process environment.

When analytical test results are available that establish presence of an allergen not intentionally added to the food, the draft CPG directs investigators to consult with the CFSAN/Office of Compliance on the health hazard posed by the product to determine whether the product is adulterated. A case-by-case evaluation of the allergen health hazard will include factors such as estimated exposure to unintended allergen presence per eating occasion, likelihood of product consumption by allergic consumers, any mitigating allergen information on the product, and other evidence such as evidence of insanitary practices, type of allergen control problem resulting in cross-contact, characteristics of allergen residues due cross-contact (e.g., particulates, dusts, etc.), and consumer adverse reactions.

The draft CPG explains that if there is a reasonable likelihood of serious adverse health consequences or death due to allergen misbranding or adulteration, FDA may consider immediate action to remove the food from commerce. If the company does not initiate a voluntary recall, FDA will consider other appropriate actions, such as mandatory recall, administrative detention, and/or suspension of facility registration.


Voluntary Allergen Information
FDA notes that allergen advisory statements such as “may contain [allergen]” may be used to alert consumers to the possible presence of a major food allergen due to cross-contact. They do, however, explicitly state that advisory statements are not a substitute for adherence to CGMPs and preventive controls. In a footnote, FDA states that the “presence of allergen advisory statements may be considered a health risk mitigating factor when allergen cross-contact is appropriately managed consistent with CGMPs, preventive controls, or other controls (e.g., HACCP).” This is a rare instance where FDA publicly acknowledges that advisory statements may be appropriate in certain circumstances. However, FDA also
notes that consumer adverse reactions may provide some evidence that labeling information or other factors did not effectively mitigate health risk from exposure to the allergen hazard in the product. The draft CPG also discusses the use of allergen-free claims and notes that such claims must be truthful and not misleading. FDA states expressly that if a product is labeled “milk-free,” the product should contain no milk allergen in the product. The draft CPG does not detail what controls or processes, e.g., final product testing, are needed to substantiate allergen-free claims.


Thresholds
FDA states in the draft CPG that it has not established a threshold for any major food allergen, but notes
that it is aware of published dose response data that raises the possibility that certain low-level exposure
to allergens “may not pose a health hazard to the majority of food allergic individuals.”
FDA states that where analytical test results are available when making the health hazard determination
discussed above, it will consider the estimated exposure per eating occasion to the allergen in that food.
However, FDA would also have to consider the allergenicity threshold (i.e., the maximum amount of
allergenic food that can be tolerated) of the particular allergic population consuming the product. While not explicit, this appears to indicate that FDA will take into account threshold information on a case-bycase basis when considering whether a product is adulterated due to cross-contact.

Comment Period
FDA asks for comments on the draft CPG by July 17, 2023, although the agency accepts comments on
guidance documents at any time.

Validating Consumer Cooking Instructions

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by Ryan Maus

Ready-to-eat (RTE) products are considered safe to consume without further cooking and are produced using controls such as thermal treatments that are validated to ensure that safe products are produced. However, non-ready-to-eat (NRTE) products may contain vegetative pathogens that require further cooking by the consumer to ensure that they are safe to consume. As such, cooking instructions provided by manufacturers should be validated to make sure that the NRTE product being cooked by the consumer provides the necessary lethality treatment to eliminate or reduce pathogen hazards to an acceptable level.


In 2006, FSIS issued notice 75-06 to their inspection program personnel to verify that establishments that produce certain uncooked and raw, breaded, boneless poultry products have adequate validation to support the cooking instructions that they include on the labels that will be applied to these products. FSIS has since provided guidance (FSIS-GD-2017-0017) for validation of cook instructions for these NRTE products. They also provide cook instruction validation guidance for mechanically tenderized beef products (FSIS-GD-2015-0022).

The FDA, unlike FSIS, does not have regulations addressing validation of cook instructions for NRTE products. However, the FDA fully expects NRTE products to be safe and products should contain labeling instructions related to safety (e.g., “keep refrigerated” or cooking instructions). Validation of cooking instructions by the manufacturer is a key step to ensure that products are safe when produced by consumers utilizing manufacturer’s preparation instructions. While guidance from FDA on cook instruction validation is lacking, trade associations such as the Consumer Brands Association (formerly the Grocery Manufacturer’s Association) and the American Frozen Food Institute do provide guidance.

Cook instruction validation begins with determining the appropriate lethality requirements. This can come from safe harbor time/temperature regulatory guidance, published scientific studies, and product-specific microbiological inactivation studies. The validation can then involve proving that the product meets a specific temperature after it is cooked (following the directions on the label) that meets safe harbor parameters. Or the validation may involve a microbial inactivation study, which may be more appropriate for products at greater risk of microbial contamination or those that achieve variable target temperatures
when following the cook instructions.

Factors affecting the validation include product packaging and the cooking device (e.g., microwave, stovetop oven, fryer) that can affect uniform heating of the product. Cold spots should be assessed and the amount of samples should account for variability among lots and be evaluated by a qualified individual. Cooking instructions should be reassessed when changes to ingredients and packaging occur. While validated cook instructions will provide assurance that microbial lethality requirements are met by the consumer, it should be noted that the consumer does not always follow the directions. This has led FSIS to propose declaring Salmonella an adulterant in breaded stuffed raw chicken products. Appropriate labeling or consumer education may be necessary to draw attention to the importance of following the cook instructions as they appear on the label.

Hepatitis A Outbreak Associated Frozen Strawberries

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By Ryan Maus

A new outbreak of hepatitis A virus has been associated with frozen organic strawberries and sickened five people (with two hospitalizations) from the state of Washington. The strawberries were distributed to numerous retail locations across the country, sometimes comingled with other fruit products. This has led to numerous recalls of products with best by dates as far away as November 2024. The ongoing outbreak serves as a reminder of the hazard viruses can present for certain ingredients and the subsequent products (such as smoothies and juice) in which they are often used.

Outbreaks of hepatitis A are generally reported after epidemiological evidence points to a common food or water source. The virus replicates inside human host cells and is shed in human feces. The virus does not multiply in or on foods but can be transmitted by food and water contaminated with human fecal material. Several fecal-oral scenarios leading to an outbreak include contaminated irrigation or wash water, sick field workers during harvest, or ready-to eat products contaminated by sick food handlers. The current outbreak strain of hepatitis A virus is genetically identical to the hepatitis A strain found in fresh organic strawberries that caused an outbreak in 2022. Organic strawberries in both outbreaks were sourced from farms located in Baja California, Mexico.

Hepatitis A Foodborne Outbreaks (Source FDA and CDC)

YearProductVirusIllness
2023
2022
2019
2017
2016
2016
2013
Frozen Strawberries
Frozen Strawberries
Fresh Blackberries
Frozen Tuna
Frozen Strawberries
Raw Scallops
Pomegranate Seeds 		Hepatitis A
Hepatitis A
Hepatitis A
Hepatitis A
Hepatitis A
Hepatitis A
Hepatitis A		5 (currently)
18
20
Unknown
143
292
162

Berries contaminated with hepatitis A can also pose a hazard when processed into products such as fresh fruit smoothies or juice. A recent warning letter was issued to a juice manufacturer that used contaminated strawberries in the formulation of a high pressure processed (HPP) juice product. The manufacturer did not validate that the HPP treatment would produce the required minimum 5-log reduction to control the target pathogen (hepatitis A virus). Generally, cooking food until it’s at a
temperature of 190˚F in the middle for at least 1½ minutes or boiling food in water for at least 3 minutes inactivates the virus. However, if present, the virus is very hardy and can survive on food, in water, and on environmental surfaces for extended periods of time. Hepatitis A illness usually begins about 2-4 weeks after exposure causing symptoms of fever, low appetite, nausea, vomiting, diarrhea, muscle aches, and jaundice. The virus can clear on its own within a week or two.

However, in some instances, the infection can last up to 6 months and cause inflammation and damage to the liver. Although the virus cannot grow in the
environment, it is considered to be extremely stable under a wide range of environmental conditions, including freezing, heat, desiccation, and chemicals. Concentrations of disinfectants commonly used against pathogenic bacteria might not be effective. A vaccine for the virus has provided a reasonable control measure to prevent the spread of hepatitis A. Preventive measures generally include good food handler hygiene, supplier verification programs, use of potable water, thermal processing, and proper sanitation.