Recalls

The World Health Organization estimates showing that one in ten people annually get sick from FoodBorne Illness (FBD), and that around 420,000 die globally as a result.

The U.S. Center for Disease Control (CDC) estimates that 1 in 6 Americans (48 million) contract a foodborne illness yearly with 128,000 people hospitalized and 3,000 dead as a result of these illnesses.

Between 2013-2019, in the U.S. the most hazardous meat and poultry recalls (Class I) increased 85%.

In the U.S., Companies reported recovering an average of 16% of recalled meat and poultry in completed recalls between 2013-2019. While the number of poultry recalls was similar to previous years, the 17 million pounds of poultry and egg products recalled last year more than tripled the average of the previous six years.

The average cost of a recall to a food company is $10M in direct costs, in addition to brand damage and lost sales according to a joint industry study by the Food Marketing Institute and the Grocery Manufacturers Association.

A separate GMA sponsored survey found 5% of companies incurred over $100m in direct and indirect costs, also found that 58% of companies had been impacted by food recalls, with 6% having an impact from 11-20 recalls.




However, if we reviewed the history of food recalls those numbers could increase drastically causing downsizing and even bankruptcy.



Costs of a food recall

The direct costs of a food recall include:

  • Assembling the crisis team
  • Removal of the product from the market, which includes:
    • Issuing notifications to regulatory bodies, businesses affected in the supply chain and consumers
    • Collecting the product from warehouses, retailers and consumers
    • Storage of the recalled product
    • Destruction of the product
  • Investigation of the root cause of the factor that caused the recall
  • Managing the PR to inform customers and protect the business reputation


Indirect costs of a food recall include:

  • Litigation costs, from claiming damages (from others or others from you) or prosecution by government agencies
  • Fines from government agencies
  • Lost sales.- Retailers sometimes will pull not just recalled products from stores, but a entire line. Our clients may be reluctant to continue with the same volume
  • Decline in value on the stock market
  • The impact on brand reputation in the industry and with consumers

Some reasons for recalling:

  • Microbial - contamination with pathogenic microorganisms such as bacteria, viruses or parasites
  • Labelling - non-compliant labelling, incorrect food ingredients on the ingredient list, incorrect date markings or other food labelling errors
  • Foreign matter - contamination with material such as glass, metal or plastic objects
  • Chemical/other contaminants - contamination with substances such as cleaning products, pesticides, machine oil, etc
  • Undeclared allergen - due to incorrect labelling, incorrect packaging or contamination of the product by an allergen
  • Packaging fault - where a fault in the food packaging results in contamination (presence of glass/metal etc) of the food or a potential choking hazard
  • Biotoxin - contamination with biological toxins such as histamine in fish and paralytic shellfish toxin in oysters
  • Other - for example, unsafe levels of additives

Example: a food may contain an allergen, such as nuts or eggs, but those ingredients do not appear on the label

Here you could watch some examples of (in)famous recalls




Food Recall Basics

Product Recall is defined by FAO as the action to remove food from the market at any stage of the food chain, including that possessed by consumers.

In the U.S., Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery. - 21 CFR 7.3(g)

In the European Union, Article 19 of EC Regulation 178/2002, Places responsibility on food business operator (importer, producer, processor, manufacturer or distributor) - if they have reason to believe food not in compliance with food safety requirements to immediately withdraw food, to inform competent authorities and if necessary to effectively and accurately inform consumers of the reasons for the recall.

Means of protecting the public health and well-being.

Food recalls are overseen by diferent Authorities:

  • U.S. Department of Agriculture (USDA) oversees meat, poultry, and pasteurized egg products.
  • U.S. Food & Drug Administration (FDA) oversees everything else.
  • European Commission - DG SANTE and Member States Agencies
  • Canadian Food Inspection Agency (CFIA)
  • FSANZ coordinates and monitors food recalls in Australia. In New Zealand, food recalls are coordinated by the Ministry for Primary Industries. FSANZ cannot order or force a recall because it has no enforcement powers. These powers rest with the jurisdictions
  • Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF)

Almost all recalls are voluntary, the agencies usually can compel a company to issue a recall in special cases.

Very few food recalls make the news.

  • Many recalls involve allergens, mislabeling of products
  • Fewer involve contamination by pathogens

Food has often been consumed by the time recall issued.

Sometimes stores will provide information to consumers about recalls.

A subrecall refers to the action taken by a recalling firm's consignees to extend the recall to subsequent levels of distribution, provided that the consignee did not further manufacture the recalled product.

If the consignee further manufactured the product (repacked or used as in ingredient), they have created a new product and need to consider if they need to initiate their own recall

To this end an efficient and successful product recall procedure involving products manufactured by the Food Business Operator (FBO) is necessary and should reduce or save a serious liability claim against the manufacturer and maintain a helpful relationship of trust with the customer.

All product recalls have customer and public relations implications that make it absolutely necessary that a recall be handled quickly and properly and that it be well documented so that future legal defence, if required, may be based on the company having taken proper and timely action to minimise any threat to the farmer's production or any government intervention.

External Recall

The removal of product from the market in which distribution has been made beyond the direct control of Food Business Operator (FBO).

Internal Recall

The removal of product from the market, none of which has left the direct control of the manufacturer.

Correction

Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. 21 CFR 7.3(h)

Market withdrawal

Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. 21 CFR 7.3(j)

Stock Recovery

Stock Recovery - a firm's removal or corrections of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on the premises owned by or under the control of the firms and no portion of the lot has been released for sale or use.

Recalls Classifications

Indicate the relative degree of health hazard presented by the product being recalled.

Examples of Class I Recalls

  • Pathogens in ready-to-eat food
    • Salmonella
    • Listeria monocytogenes
    • E. coli O157:H7
    • Clostridium botulinum
  • Allergens: milk, eggs, peanuts, tree nuts, crustaceans, fish, soybeans
  • High levels of sulfites
  • High levels of heavy metals
  • Choking hazards for susceptible populations

Examples of Class II Recalls

  • Foreign objects that pose a physical hazard
  • Pathogens: Shigella, hepatitis A, Cyclospora, Cryptosporidium
  • Allergen: wheat

Examples of Class III Recalls

  • "Unfit for food" where hazard is not likely
  • Low levels of pesticide residue

Determining the scope of a recall

  • When did the problem start/end
  • Can additional lots/products be affected other than the lot/product analyzed and found adulterated
  • How many sizes/labels for the product
  • Is the product coded with a lot number
  • Shelf life of product

Recall Strategy

A planned specific course of action to be take in conducting a specific recall, which addresses the depth of the recall, need for public warnings, and extent of effectiveness checks for the recall. 21 CFR 7.3(l)

A recall strategy should contain at least the following elements:

  • depth of recall, which may extend to the consumer level, the retail level, or the wholesale level;
  • the contents of public notifications to be issued depending on the classification and severity of the grounds for which a recall is issued;
  • during urgent situations, public warning that is given nationwide or to affected geographical areas;
  • effectiveness check level, which includes the method to be used for and depth recall effectiveness checks; and
  • the disposal of recalled products.
  • A recall strategy should take into account at least the following factors:

    • the health hazard evaluation;
    • the type or use of the product;
    • the ease in identifying the product;
    • the degree to which the product's deficiency is obvious to the consumer or user;
    • the amount of product remaining unused in the marketplace;
    • the distribution pattern; and
    • the continued availability of essential products.

    Evaluating Health Hazard

    You must do it; and FDA also will do it and its decision will govern; rarely reversed

    Factors addressed in a Health Hazard Evaluation (HHE)

    • Has disease or injury occurred due to use of (violative) product?
    • Could existing conditions contribute to a clinical situation that could expose humans (or animals) to a health hazard?
    • How will the hazard impact (e.g., differently) various population segments?
    • Degree of seriousness of HH to which at risk populations would be exposed
    • Assessment of likelihood hazard will occur
    • Assessment of consequences - immediate or long-term - if hazard occurs

    Requirements for a Recall Plan

    • For food with a hazard requiring a preventive control
      • (a) Establish a written recall plan
      • (b) Include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions:
        • (1) Directly notify the direct consignees of the food being recalled
        • (2) Notify the public about any hazard presented by the food
        • (3) Conduct effectiveness checks to verify that the recall is carried out; and
        • (4) Appropriately dispose of the recalled food

    U.S. -> 21 CFR 117.139

    Australia/NZ -> All food manufacturers, importers and wholesale suppliers must have a written food recall plan, under clause 12 of Standard 3.2.2 Food Safety Practices and General Requirements. The plan should cover the procedures, records and staff responsibilities a business needs in place for a food recall.

    All food businesses should make sure their recall plan is correct, up to date and relevant for their particular operations.

    Develop a Corrective Action Plan

    • Identification of the product.
    • Scope of recall:
      • How much of the product may have been affected?
    • Depth of recall:
      • Who is affected: Distributor, Retailer, Consumer?
    • Disposition of recalled product:
      • Does it require: Destruction, Correction, Recondition?
    • Plan for replacement or reimbursement.
    • Plan for public notification
      • Written recall notifications, phone notifications, press releases, social media, etc.
    • Effectiveness checks and status reports.

    Specific plan elements will be influenced by the nature of the product, hazard level, recall classification, extent of product distribution, etc.

    Recall initiated by a food business operator

    Where a food business operator has reason to believe that a traceable item which has been imported, produced, processed, manufactured or distributed is not in compliance with the Act, he/she shall immediately take any of the following recall actions specifying the prescribed particulars of the traceable product to be recalled:

    • develop a recall strategy that meets the requirements;
    • stop the distribution of the product;
    • withdraw the product from the market;
    • notify the public, trading partners and consignees of a recall as prescribed;
    • effectively and accurately inform the consumers of the reason for the recall and, if necessary, recall from consumers the products that have already supplied to them (when other measures are not sufficient to guarantee food safety) following the procedures established by the Competent Authority;
    • issue a press release if so directed by the Competent Authority; and
    • abide by other recall requirements as may be established by the Competent Authority.

    The food business operator may request an informal discussion or hearing with the Competent Authority to discuss the recall actions to be taken, and shall provide the Competent Authority with the recall strategy and prescribed documentation.

    Recall initiated by the competent authority

    The Competent Authority could develop a recall strategy in accordance with the requirements presented in the Recall Strategy.

    Where the Competent Authority determines, based on information gathered, that there is a reasonable probability that a food is not in compliance with the Act or with relevant food standards and the use of or exposure to such food could cause adverse health consequences, the Competent Authority would:

    • provide a written recall order that includes a recall event number to the responsible food business operator, requiring a recall action to be taken within the period specified in the notice; or
    • where the food business operator does not comply with the recall order within the specified period and in the manner prescribed by the Competent Authority, or where the food business operator is unable to conduct a recall for any reason, initiate recall actions.

    Where the time frame for carrying out a recall order allows, the Competent Authority would provide the food business operator subject to a recall order with an opportunity for an informal hearing, addressing the actions required by the order and the grounds for such action.

    The Competent Authority, when necessary, would develop an interim recall strategy to cover the time between notification of a known or potential health hazard and completion of a final formal strategy. The interim recall strategy would indicate the immediate actions to be taken by the responsible food business operator.

    The Competent Authority would notify appropriate local authorities of recall actions that may be pertinent to a specific district or area. Where the local authorities request assistance, the Competent Authority would respond and assist in conducting or auditing the recall action.

    Where the Competent Authority determines, after providing opportunity for an informal hearing under subsection (4) of this section that the removal of the traceable item from the market is necessary, the Competent Authority would, either:

    • specify a timetable in which the recall shall occur, and shall amend the order to require recall of such traceable item or other appropriate action where required, and shall require periodic reports to the Competent Authority describing the progress of the recall and provide notice to consumers to whom such food product was, or may have been distributed; or
    • revoke the order, where the food business operator shows evidence that adequate grounds do not exist to continue the actions required by the recall order, or that the traceable item complies with the requirements of these Regulations.

    The food business operator would bear the costs of a recall initiated by the Competent Authority and be responsible for disposal of a recalled product.

    Report Information to the Authorities

    • Product
    • Precise problem
    • Description-Size, Date Code, Lot Code, Photograph of product if possible
    • The amount produced and when
    • The amount distributed and recovered
    • Where it has been sold
    • What action the company have taken so far
    • Who supplied product or affected ingredient
    • When did company receive affected product.
    • Any other relevant information

    Can FDA Make You Recall?

    General rule: No. But, FDA: "if we request, we will seize if you don't"

    • FDA Regulatory Procedures Manual (RPM) - if FDA requests, it is usually a Class I scenario
    • FDA requested recalls in accordance with 21 CFR 7.45. FDA Requested Recalls are ordinarily reserved for urgent situations where mandatory recall authority does not exist or is not appropriate. Additionally, FDA Requested Recalls should only be pursued following informal recall discussions with a firm per the procedure in RPM 7-5-1.

    Statutory and regulatory exceptions:

    • Infant formula
    • Medical Device recall/notification authority - §518(e)
    • Biological products under the National Childhood Vaccine Safety Act of 1986
    • Human tissue - 21 CFR 1270.43

    Do You Have to Tell FDA You're Doing A Recall?

    Technically - not always

    "Exceptions" involving notice that will trigger recall as an issue for you and FDA

    • Field Alert - 21 CFR 314.81(b)(1) - 3 working days notice to your local FDA district office any time NDA holder learns:
      • Info that its drug or labeling could be mistaken for, or applied to another article (e.g., label mix-ups)
      • Info about:
        • Any bacteriological contamination
        • Any significant chemical, physical or other change or deterioration in distributed drug; or
        • Any failure of a batch to meet its specification
    • ANDA Stability Commitment - signed part of ANDA that you will recall any batch that falls out of specification.
    • PMA Conditions of Approval - must report to FDA within 10 days after the applicant receives or has knowledge of information concerning:
      • A mix-up of the device or its labeling with another article.
      • Any adverse reaction, side effect, injury, toxicity, or sensitivity reaction attributable to the device and:
        • not addressed by the device's labeling; or
        • addressed by device labeling but occurring with unexpected severity or frequency.
      • Any significant chemical, physical or other change or deterioration in the device, or any failure of the device to meet the specifications established in the approved PMA that could not cause or contribute to death or serious injury but are not correctable by adjustments or other maintenance procedures described in the approved labeling

    Practically - yes; FDA expects it

    U.S. Food Safety Modernization Act

    • Gives FDA a new system of import controls (foreign supplier verification program, third party certification for imported foods)
    • Gives FDA mandatory recall power if companies fail to voluntarily recall
    • Expands administrative detention (FDA can keep suspect food from being moved)
    • FDA can suspend registration of facility (cannot import or ship food until satisfactory corrective action taken)
      • Can suspend registration of a food facility if food has a reasonable probability of causing illness or death if eaten
    • Since 2009 FDA implemented:
      • Reportable Food Registry (RFR) implemented
      • Requires any food facility that manufactures, processes, packs or holds food for human or animal consumption to file a report through the RFR electronic portal when there is reason to believe that a food will cause adverse health consequences or death to humans or animals.
      • The report must be submitted to FDA within 10 working days from the time the firm initiates the correction or removal . If there is not a "risk to health" involved, a report to FDA is not required, but the manufacturer or importer must keep a record of the correction or removal.

    Closure

    • Complete investigation into the incident
    • Ensure all possible action has been carried out to ensure food products have been recalled or withdrawn
    • Notify all parties involved that the incident is closed whether the action was initiated by the food business operator, enforcement officers or the central authority
    • Make a summary record / report of the outcome including details on the quantity of product recalled / withdrawn / returned / destroyed

    European Union - Particularities

    3 Key Stages

    • Risk Assessment - undertaken by relevant policy group on the instruction of NCP and team.
    • Risk Management - Decision on the actions that need to be taken reflecting the risk assessment
    • Risk Communication - How we make stakeholders aware of the issue

    Risk assessment

    • Nature of contaminant?
    • What/who is affected?
    • What is the estimate of exposure?
    • Can risk be quantified?
    • Media/press interest?
    • Political factors?
    • Public interest and perceptions?
    • Do you have enough resources to handle the incident?

    Risk Classification

    • Agency matrix - High/Medium/Low
    • Resource allocation
    • Severity
      • Health Effects
      • Consumers affected
      • Risk assessment
      • Perceived risk
      • Potential media interest
    • Complexity
      • Number of reports
      • Number of products/locations
      • Number of Agencies involved
      • Traceability

    Risk management Options

    • Withdraw/recall
    • Restrictions
    • Increased sampling/monitoring
    • Advice to consumers
    • Prevent imports
    • Take no action

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