RECALL READINESS Presentation Prepared for the Colorado Fruit and - - PowerPoint PPT Presentation

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RECALL READINESS Presentation Prepared for the Colorado Fruit and - - PowerPoint PPT Presentation

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RECALL READINESS Presentation Prepared for the Colorado Fruit and Vegetable Growers Association Recall Readiness and Crisis Management Workshop November 14, 2017 J. Lee Gray Partner IS A RECALL PLAN REQUIRED? Register as Food Facility?

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RECALL READINESS

Presentation Prepared for the Colorado Fruit and Vegetable Growers Association Recall Readiness and Crisis Management Workshop November 14, 2017

  • J. Lee Gray

Partner

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IS A RECALL PLAN REQUIRED?

  • Register as Food Facility?

No Yes

“Farm” “Mixed-Type Facility”

  • One physical location
  • Any other processing not entirely

consumed on farm

  • Growing crops
  • “slicing” or irradiating product
  • Raising animals/seafood
  • Pack/hold raw commodities
  • Drying/dehydrating raw

commodities

  • Ripening
  • Packaging/labeling raw items
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DISCLAIMER

  • This presentation is intended to provide general

information on pertinent legal topics, and the statements are made for educational purposes only. They do not constitute legal advice, and do not necessarily represent the views of Holland & Hart LLP or any of its attorneys

  • ther than myself. This presentation is not intended to

create an attorney-client relationship between you and Holland & Hart LLP. If you have specific questions as to the application of the law to your activities, you should seek the advice of legal counsel.

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  • Not located on Primary Production Farm
  • Harvesting, packing, and/or holding
  • Owns, jointly owns majority interest

SECONDARY ACTIVITIES FARMS ARE NOT REQUIRED TO REGISTER

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RECALL PLAN

  • Mandated for FDA Registered Food Facilities
  • But everyone should have a recall plan
  • During an outbreak is too late
  • Mock recalls, audits
  • “traceability exercise”
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RECALL PLAN

  • Recall Team Role
  • Monitor reports of issues
  • Investigate
  • Assess the hazard
  • Make the recall determination and
  • Oversee the entire recall process,

through closure.

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RECALL PLAN

  • Recall Team (con’t.)
  • All stakeholders; representatives from the following

business functions:

  • Regulatory/Legal
  • Operations Manager
  • Scientific Advisor
  • Quality Assurance/Control
  • Marketing/PR
  • Customer Service
  • Logistics/receiving
  • Recall Coordinator
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RECALL PLAN

  • Monitor
  • Consumer complaints
  • Test results/QC
  • News reports
  • Agency reports
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RECALL PLAN

  • Investigate/Evaluate
  • Identify and document:

 Source of report  Root cause/source (if possible)  Severity of potential risk  Likelihood of injury  Scope of affected product  Recall decision

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RECALL PLAN

  • Recall Actions
  • Assign team member responsibilities
  • Document/log all:
  • Events
  • Reported Injuries/issues
  • Actions
  • Communications
  • FDA report
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RECALL PLAN

  • Recall Actions (con’t.)
  • Issue notices/press releases
  • Include social media
  • Monitor recall
  • Dispose of products (Apply and Document!)
  • Apply for termination of Recall
  • Debrief team/lessons learned
  • Prepare for legal issues
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REPORTABLE FOOD REGISTRY

  • “Reportable food”
  • Class I recall situation
  • Reasonable probability
  • Serious adverse health consequences or

death

  • To humans or animals
  • Contamination (e.g., Salmonella, Listeria)
  • Undisclosed allergen
  • Other danger (e.g., choking hazard)

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REPORTABLE FOOD REGISTRY

  • When to report?
  • 24 Hours after

determining food is reportable

  • When not to report?
  • If adulteration originates

within facility,

  • is not transferred to

anyone else (including distributor), and

  • Is corrected/destroyed.

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REPORTABLE FOOD REGISTRY

  • How to report?
  • Online portal (http://www.safetyreporting.hhs.gov)

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REPORTABLE FOOD REGISTRY

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REPORTABLE FOOD REGISTRY

  • Attachments:
  • .pdf – Portable document format.
  • .jpg, .jpeg – Image file format.
  • .tiff - Tagged image file format.
  • .rtf – Rich text format.
  • .txt – Text format.
  • .xls – Spreadsheet file format.
  • .doc, docx – Word processing document

formats.

  • .wpd – Word processing document format.

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REPORTABLE FOOD REGISTRY

  • What information to report?

1) The responsible party’s registration numbers 2) The date food was determined to be a reportable food; 3) Description of food (including the quantity or amount); 4) Extent and nature of the adulteration; 5) Results of any investigation of the cause of the adulteration, when known;

  • And if originated with the responsible party

6) Disposition of the food, when known; and 7) Product information typically found on packaging

  • product codes, use-by dates, and the names of

manufacturers, packers, or distributors sufficient to identify the article of food

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REPORTABLE FOOD REGISTRY

  • Online form
  • Contact information
  • Summary of the

problem

  • Affected products
  • Distribution information
  • Supplier information
  • Attachments

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WHEN TO RECALL

  • When you determine that a food item

presents a reasonable probability of serious adverse health consequences or death.

  • Develop process for making recall decision
  • Determine root cause of the issue
  • Determine and identify risks
  • Assess severity of risks
  • Determine actions to avoid recurrence
  • Checklist for documenting recall decision
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Recall Decision

WHEN TO RECALL

  • Health Hazard Evaluation (HHE)
  • Team sport:

Legal Customer Service Quality Regulatory Operations Marketing Scientific Advisor

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WHEN TO RECALL

  • Examples of Class I recalls:
  • Lettuce contaminated with Salmonella.
  • Cantaloupes contaminated with Listeria and Salmonella.
  • Sprouts contaminated with E. coli.
  • Under-processed canned chili that contained Clostridium

botulinum toxin.

  • Smoked salmon contaminated with Listeria.
  • Ice cream containing peanut butter, but that did not declare

peanut-derived ingredients as an ingredient.

  • Baby food that posed a choking hazard.
  • Horse feed contaminated with elevated levels of monensin.
  • Pet food contaminated with elevated levels of melamine and

cyanuric acid.

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WHEN TO RECALL

  • Look for:
  • Contamination

(biological, chemical, physical)

  • Tests
  • Illness data
  • Scientific reports
  • Consumer reports
  • News of outbreak
  • Supplier reports

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  • Sources of contamination
  • Formulation
  • Facility/equipment
  • Transportation
  • Processing procedures
  • Packing/labeling
  • Storage/distribution
  • Sanitation/employee

hygiene

  • Misbranding
  • Allergens
  • Claims
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WHEN TO RECALL

  • Evaluate the hazard
  • Severity of illness
  • Probability of

injury/hazard without corrective action

  • Affected population
  • Scope of hazard

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HANDLING CONSUMER COMPLAINTS

  • Customer service script
  • Document all calls
  • Collect all relevant information possible
  • Product ID/lot numbers
  • Demographics
  • Description of incident/injury
  • Date, time and location
  • Use data
  • Evaluate potential hazard
  • Evaluate/validate preventative controls

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PENALTIES AND THE PARK DOCTRINE

  • Park Doctrine:
  • A responsible corporate official can be held

criminally liable for violation of the FDCA

  • without proof that the corporate official acted with

intent or even negligence, and

  • even if such corporate official did not have any

actual knowledge of, or participation in, the specific

  • ffense.
  • First-time misdemeanor
  • Subsequent felony

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PENALTIES AND THE PARK DOCTRINE

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  • Over 700 confirmed illnesses
  • 46 states
  • 9 consumer deaths
  • Knowingly shipped

contaminated product

  • 76 Count criminal indictment
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PENALTIES AND THE PARK DOCTRINE

  • Uses by FDA

– Deterrent effect

– To obtain documents by subpoena

  • Office of Criminal investigations (OCl)

– Reviews all recommended investigations – Determines whether to proceed

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PENALTIES AND THE PARK DOCTRINE

  • Factors considered by OCI:
  • Whether the violation involves actual or

potential harm to the public;

  • Whether the violation is obvious;
  • Whether the violation reflects a pattern of illegal

behavior and/or failure to heed prior warnings;

  • Whether the violation is widespread;
  • Whether the violation is serious;
  • The quality of the legal and factual support for

the proposed prosecution; and

  • Whether the proposed prosecution is a prudent

use of agency resources.

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INSURANCE ISSUES

  • Common losses (risks)

– Cost of risk prevention – Cost of investigation – Recall costs

  • Crises management/PR
  • Legal
  • Logistics (reverse distribution/product destruction)
  • Brand rehabilitation

– Third-party liability (personal injury/property damage) – Business interruption – Supply chain claims

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INSURANCE ISSUES

  • Types of insurance
  • General liability
  • First party property
  • Business interruption
  • Contamination/recall
  • Voluntary recall
  • Exclusions
  • D&O

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INSURANCE ISSUES

  • Contamination/recall policies
  • Accidental contamination
  • What is contamination?
  • Link to bodily injury/property damage
  • Triggering event?
  • Governmental action?
  • Adverse publicity
  • Impaired ingredients
  • Malicious contamination

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INSURANCE ISSUES

  • Contamination/recall policies (con’t.)
  • Exclusions/limitations
  • GMO or specialized causes of loss
  • Criminal misconduct exclusions
  • Unidentified vs. identified products
  • Terminology
  • Third-party loss
  • Sublimits
  • Calculating and tracking loss

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INSURANCE ISSUES

  • In case of crisis:
  • Know importance of early decisions
  • Notice
  • Choice of counsel
  • Cooperation
  • Resolving disputes
  • Coverage
  • Supply chain

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CONTACT

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  • J. LEE GRAY

303.290.1602 lgray@hollandhart.com