Food Safety Regulation and Litigation: Minimizing the Risk of Product Liability Claims Mastering the Standards for Fault, Causation and Damages in Food Safety Litigation Today’s faculty features: 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 1. THURSDAY, FEBRUARY 21, 2019 Presenting a live 90-minute webinar with interactive Q&A Kim Bousquet, Partner, Thompson Coburn, St. Louis David A. Ernst, Partner, Davis Wright Tremaine, Portland, Ore.
Transcript
Food Safety Regulation and Litigation:
Minimizing the Risk of Product Liability ClaimsMastering the Standards for Fault, Causation and Damages in Food Safety Litigation
The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 1.
THURSDAY, FEBRUARY 21, 2019
Presenting a live 90-minute webinar with interactive Q&A
Kim Bousquet, Partner, Thompson Coburn, St. Louis
David A. Ernst, Partner, Davis Wright Tremaine, Portland, Ore.
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Food Safety RegulationsExploring Food Safety Regulations, the Food Safety Modernization Act, and Potential Impacts of Regulatory Changes on Liability Risk
Kimberly M. Bousquet
Today’s Menu
MENUBreakfastOverview of The Food Safety Legal System
LunchThe Food Safety Modernization Act
DinnerLiability Risks in The New Regulatory Environment
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BreakfastOverview of The Food Safety Legal System
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Why Are We Talking About This?
Annually 48 million people in the U.S. (1 in 6) get sick,
128,000 hospitalized, and
3,000 die
From foodborne diseases (CDC)
Foodborne illness outbreak is the existential threat to your food company.
Other issues: EMA, Food Defense, Allergens, FM Contamination
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What are we talking about?
The Current Regulatory Scheme
Who has primary responsibility for assuring that U.S. food is safe?
What laws set forth these responsibilities?
How are these responsibilities implemented?
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What came before?
Original Food Safety Concept Organoleptic Inspection (sight, touch, smell)
1906 – the Pure Food and Drug Act and the Federal Meat Inspection Act – focus on unsanitary conditions
Transition to HACCP 1993 unprecedented E. Coli outbreak in PNW; 400
sick, four deaths
USDA established Pathogen Reduction and Hazard Analysis and Critical Control Points
Pathogen-based
1995 – HACCP mandated for seafood only
1996 – Large Meat and Poultry Processing Plants Required to follow HACCP
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What’s here now?
2011 – FSMA and the HARPC – FDA regulated foodsUshered in a new era in food safety regulation
Considered the most significant food-safety legislation in more than 70 years
Attempt to Shift Focus From Response to Prevention
Seven Major Rules
Much Broader Focus: farmers, processers, importers, shippers
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Federal Framework
FDA(Food & Drug
Administration)
USDA-FSIS(Food Safety Inspection
Service)
States & Local Authorities Other Agencies With Supporting Roles
Domestic and imported foods marketed interstate, except meat and poultry products.
Enforces pesticide tolerances w/testing (set by EPA)
Dietary supplements
Seafood (except catfish)
Inspections of Registered Facilities: Based on Risk Level --- B/w 10 and 30 % inspected annually (25K out of 88K); High Risk every year; others 5-10
Meat and Poultry Products that move in interstate commerce
Law requires “continuous” Inspections:
Present in every slaughter plant at all times;
Present in processing establishments at least once per day
6400 facilities
Retail Food Establishments
Health Departments –Restaurants
Agriculture Departments –Supermarkets
Inspect intrastate sales of meat and poultry under FSIS Supervision
Milk – Separate Ordinances
TTB – Alcohol and Wines Greater than 7% Alcohol
CDC – Surveillance and Investigation of Illnesses
NMFS – Voluntary Grading of Seafood
AMS – Grading Standards for Shell Eggs
GIPSA – Grading Standards for Grain
EPA – Sets pesticide food tolerances; regulates food plant detergents and sanitizers; chemicals for food use
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Federal Food, Drug & Cosmetics Act (FDCA)
Food is adulterated when it is
1) Poisonous or deleterious – injurious or unsafe
2) filthy, putrid or unfit for food
3) prepared under insanitary conditions
4) diseased
5) poisonous or deleterious packaging
6) irradiation regulation
If one of these, then sale, shipment violates FDCA
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LunchThe Food Safety Modernization Act
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The Food Safety Modernization Act (FSMA)
Est. 2011
The FDA did little to implement FSMA’s requirements until sued.
In the last few years, the FDA has implemented many new rules and guidances.
Deadlines – most past; some still pending; ever changing.
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FSMA: Who Cares?
Generally- (for Human and Animal foods)
Food Chemical Companies
Food Ingredient Companies
Food Processors, Packers, Handlers, Warehousing and Delivery
Restaurants
Packaging Manufacturers
ALL are impacted in various ways, whether by direct responsibility, or requests from customers
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FSMA Basics
FSMA Regulations1. FSMA Regulations: HARPC and cGMPs
2. Facility Registration
3. Produce Safety Rule
4. Foreign Supplier Verification
5. Sanitary Transport Rule
6. Whistleblower protections
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FSMA Basics: HARPC and cGMPs
What:
Hazard Analysis and Risk
Based Preventive Controls and
Current Good Manufacturing
Practices
AKA HARPC
Applies to:
• The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States (animal or human food)
Includes foreign facilities
Does not include farms, and only cGMPs apply to facilities involved in alcohol products.Where:
• 21 C.F.R. § 117 et seq
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FSMA Basics: HARPC and cGMPs
A written HARPC must include Process Analysis
Hazard Identification
Preventive Controls
Corrective Action Plan
Supply Chain Program
Records Keeping
Training component with documentation of the training materials and attendance
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FSMA Basics: HARPC
HARPC = Food Safety Plan
Process Analysis: Understand manufacturing and processing from component/ingredient source to final product shipment.
Hazard Identification: Identify the hazards that are present in the processing of materials that threaten the integrity of final products. This includes:
1. Biological Hazards
2. Physical Hazards
3. Chemical Hazards
Hazards should be classified by risk, based on their possible impact and likelihood of occurring.
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FSMA Basics: HARPC
Preventive Controls: Once hazards are identified, controls are created to mitigate those hazards based on their risk. The greater the impact and likelihood, the more stringent the control. Can include processes, cleaning, monitoring, etc.
Corrective Action Plans: Pre-emptive plans created to respond in the case that one of the hazards occurs. These can include reprocessing, product disposal, FDA notification, recalls, etc.
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FSMA Basics: HARPC
Supply Chain Program: Establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control. (Essentially, impose HARPC procedures upon suppliers)
Records Keeping Requirements: Vary between components of the plan, but generally must be available on-site.
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FSMA Basics: HARPC
Monitoring the Food Safety Plan Record keeping is key
Not only must hazards and preventive controls be in writing, but their monitoring must be as well
Records must be retained for two years; six months on site
Evidence that the plan is reviewed regularly and updated as needed
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FSMA Basics: HARPC
Recalls and Corrective Actions: final piece of the FSP
FSP must include a process for recalls and implementation of corrective actions that not only remedy the failure but also correct the cause of the failure or adulteration going forward
Processes must be in writing, and in the event of a recall or corrective action, all responses and actions must be documented
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FSMA Basics: Facility Registration
Facilities involved in holding, packing, manufacturing, storing or otherwise processing food products have long had to register with the FDA
FSMA has amended these requirements
Facilities must provide email addresses for facility FDA contact people
Facility registrations now assure access to FDA inspectors as required under the FDCA
Bi-annual renewal of registrations
Mandatory electronic registration (1/2020)
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FSMA Basics: Produce Safety Rule
A far-ranging rule; first time food safety is on the farm
Personnel qualifications and training
Health and hygiene
Agricultural water
Biological soil amendments
Domestic and wild animals
Growing, harvesting, packing and holding
Equipment, tools, buildings and sanitation
Sprouts
Record keeping
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FSMA Basics: Foreign Supplier Verification
Importers must have a system in place to evaluate and approve suppliers.
Importers are required to verify that approved suppliers are fulfilling their requirements.
Domestic companies will be held accountable for its foreign partners; have an affirmative obligation to understand their supply chain.
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FSMA Basics: Sanitary Transport Rule
Applies to shippers, receivers, loaders, and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.
Responsibilities can be reassigned/delegated in a written agreement, to another party subject to the rule.
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FSMA Basics: Sanitary Transport Rule
Transportation operations must be conducted to prevent food from becoming unsafe during transport, including:
Ensuring adequate temperature controls
Preventing contamination of food by contact with raw food or non-food items
Protection from food allergens cross-contact
Protection of food transported in bulk
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FSMA Basics: Whistleblower Protections
The federal Occupational Safety and Health Administration has long offered protection to individuals raising concerns about possibly illegal company behaviors.
These protections now include those employees of food companies regulated by the FDA.
Employer can take no actions against an employee who participates in identifying a company’s participation in activities that the employee “reasonably believes” violate the FDCA.
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DinnerLitigation & Liability Risks in The New Regulatory Environment
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Food Safety Liability Risks
Liability Risks Exist Throughout the Supply Chain
Four Primary IssuesIncreased Regulatory Scrutiny / Enforcement
Actions
Products Liability / Injury Suits
Whistleblower Actions
Criminal Liability
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Enhanced Regulatory Scrutiny
Results of FSMA FDA Mandatory Recall Authority
Heightened Access to Records During Inspection
Enhanced Administrative Detention
Increased Inspections
Increased Funding for Outbreak Investigations
Additional Traceability Requirements – One Step Forward, One Step Back
Can Suspend Facility Registration in Certain Circumstances
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HARPC and The Risks
Failure to Create a Food Safety Plan
Failure to Implement, or Properly Implement a Food Safety Plan
Failure to follow a Food Safety Plan
Resulting in Injury to a consumer
Damage to a business
Failure to pass an FDA inspection Form 483, Warning Letters, and possible litigation
by the FDA
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HARPC and The Risks
From a Plaintiff’s perspective How does having a detailed written food safety
plan play out in a Lawsuit?
Is the FSP a roadmap to proving liability?
How does the requirement that company’s must identify foreseeable risk impact a company’s liability in litigation?
Will the plaintiff have a stronger case by challenging the adequacy of the preventive controls and corrective action plans?
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HARPC and The Risks
From a Defendant’s perspective Company with strong FSP has identified
foreseeable hazards and can prevent them
Mitigation and damages Strong recall & corrective action plan = less
risk, ID risky supply relationships, better ensure customers of product safety
Plan may be used against the company in litigation.
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Lessons from HACCP Litigation
HACCP plans regularly arise in products liability litigation
These issues usually go to standard of care, the duties owed by the food manufacturer and whether they were followed
Does HARPC elevate the standard of care?
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Criminal Liability
Misdemeanor conviction under FDCPA
Does not require proof of fraudulent intent or knowing or willful conduct
Only need person with responsible authority that could have prevented the violation
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Whistleblower Lawsuit
First published case
Chase v. Bros. Int'l Food Corp., 3 F. Supp. 3d 49, 55 (W.D.N.Y. 2014)
MTD denied; Plaintiff stated prima facie case: (1) complained to management regarding re-dating products
and selling products which might be subject to bacterial contamination is protected activity;
(2) was fired, and
(3) was fired as a direct response to his making complaints regarding violations of the FSMA
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Mandatory Recall Authority
April 2018 -- FDA issued its first-ever mandatory recall of a food product last April (Kratom)
The mandatory action was deemed necessary when the company failed to cooperate with FDA’s requests to issue a voluntary recall.
FDA can order recall when (1) FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling and (2) the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.
