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Food Safety.

  • ID: 2128031
  • Book
  • February 2015
  • Region: United States
  • 470 Pages
  • ALM Media, LLC
Americans experience as many as 76 million foodborne illnesses each year — a problem that has led to an unprecedented level of litigation. Food Safety Law is the definitive guide to this rapidly growing practice area. Whether you represent food producers concerned about liability or plaintiffs harmed by a foodborne illness, this unique book will help you handle any issue.

Food Safety Law examines the entire administrative maze, with particular emphasis on the USDA and FDA, including the Food Safety Modernization Act. The authors analyze the legal and practical issues food safety attorneys face, from prevention and compliance to recalls and litigation after an outbreak. Topics covered include: inspections; detection of outbreaks; food safety threats; injurious objects in food; current good manufacturing practices; recall strategies; causes of action and defenses; proving causation; complex litigation; insurance coverage; labeling requirements; and the newest legal frontiers.

Even a mid-sized recall involves issues of regulatory compliance, product liability litigation, insurance coverage, and more. Whether you represent food producers or plaintiffs, whether you are advising a company on how to steer clear of problems or doing damage control after the fact, Food Safety Law is an essential touchstone for legal counsel.
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Introduction to Food Safety Law
- 1.01 Introduction
- 1.02 Food Safety Issues

The Regulatory Framework
- 2.01 Introduction
- 2.02 United States Department of Agriculture (“USDA”)
[1] Overview [2] USDA Food Safety Regulatory Authority
- 2.03 Food and Drug Administration (“FDA”)
[1] Overview
[2] Regulatory Authority
[3] Criticism and Reform
- 2.04 Other Food Regulation Agencies
[1] U.S. Customs and Border Protection (“CBP”), Department of Homeland Security
[2] National Marine Fisheries Service (“NMFS”), U.S. Department of Commerce
[3] Environmental Protection Agency (“EPA”)
[4] Centers for Disease Control and Prevention (“CDC”)
- 2.05 Congressional Oversight and Regulatory Developments
[1] Congressional Oversight
[2] Legislative and Regulatory Developments
- 2.06 State Regulatory Agencies

- 3.01 Introduction
- 3.02 United States Department of Agriculture (“USDA”) Inspections
[1] Facilities Subject to Inspection
[2] The Continuous Enforcement Approach
[3] Products Subject to Inspection
[4] FSIS Enforcement
- 3.03 Food and Drug Administration (“FDA”) Inspections
[1] Authority for Inspections
[2] Inspection Procedure
[3] Inspection Results
- 3.04 Office of Criminal Investigations (“OCI”)
[1] Background
[2] Violations and Penalties

Public Health Surveillance and Accessing Public Health Documents
- 4.01 Introduction to Public Health Surveillance
- 4.02 Overall Structure of Foodborne Illness Reporting
[1] Population Surveys
[2] Physician Surveys
[3] Laboratory Surveys
- 4.03 Notifiable Disease Surveillance
[1] Notifiable/Reportable Diseases and Disease Reporting
[2] Nationally Identifiable Diseases
[3] Patient and Health Care Provider Responses
[4] Disease Reporting in Minnesota
- 4.04 Detection and Data Collection by Federal Agencies
[1] Centers for Disease Control and Prevention
[2] OutbreakNet
[3] FoodNet
[4] PulseNet
- 4.05 The Reportable Food Registry
- 4.06 Accessing Government Information
[1] Private Information and Public Health Surveillance
[2] Freedom of Information Act
[3] State Sunshine Laws

Food Safety Threats
- 5.01 Introduction
- 5.02 Biologic Pathogens
[1] Escherichia coli
[2] Salmonella
[3] Listeria Monocytogenes
[4] Shigella
[5] Clostridium Botulinum
[6] Hepatitis
[7] Bacillius Cereus
[8] Campylobacter
[9] Cyclospora Cayetanensis
[10] Noroviruses
[11] Staphylococcus Aureus
[12] Vibrio Parahaemolyticus
- 5.03 Allergens
- 5.04 Chemical Hazards
[1] Diacetyl
[2] Benzene
[3] Bisphenol A
[4] Mercury

Injurious Objects in Food
- 6.01 Introduction
- 6.02 Causes of Action
[1] Negligence
[2] Warranty
[3] Strict Product Liability
- 6.03 Elements Common to All Actions
[1] Presence of an Injurious Object
[2] Damages
[3] Causation
- 6.04 Defense: Comparative and Contributory Negligence

Cloning and Bioengineering
- 7.01 Introduction
- 7.02 Cloning and Bioengineering
[1] The Origins and Applications of Bioengineering
[2] Regulatory Framework
[3] International Approaches to Regulation
[4] International Trade Disputes
[5] Litigation

Obesity Litigation and Legislation
- 8.01 Background on Obesity: Setting the Scene
- 8.02 Legislation
[1] State Legislation
[2] Federal Legislation
- 8.03 Litigation
[1] Introduction
[2] Difficulty of Proving Causation and the Influence of Other, Non-Dietary Factors

Production Countermeasures
- 9.01 Introduction
- 9.02 Production Countermeasures
[1] Current Good Manufacturing Practices
[2] General Provisions
[3] Hazard Analysis Critical Control Points (HACCP)
[4] Sanitation Standard Operating Procedures (SOPs)
[5] Labeling and Cooking Instructions
[6] Testing
[7] Voluntary Audits/Inspections

Food Product Recalls
- 10.01 Introduction to Food Product Recalls
- 10.02 Government Agencies Initiating and Overseeing Food Product Recalls
- 10.03 Regulatory Authority over Food Product Recalls
- 10.04 Types of Recalls
[1] Firm-Initiated Recalls
[2] Agency-Initiated Recalls
[3] Refusal or Failure to Initiate Voluntary Recall
- 10.05 Recall Classifications
[1] Class I Recalls
[2] Class II Recalls
[3] Class III Recalls
[4] Product Withdrawals Versus Recalls
- 10.06 Recall Plan and Recall Team
- 10.07 Conduct of Recall
[1] Scope of Recall
[2] Recall Communications
[3] Status Reports
[4] Formation of Cause/Origin Team
[5] Operational Considerations
[6] FDA/USDA Site Inspection Contemporaneous with Recall
[7] Admissibility of Recall in Future Litigation
[8] Effectiveness Checks
[9] Termination of Recall

Causes of Action and Parties in Civil Foodborne Illness Litigation
- 11.01 Causes of Action
[1] Negligence
[2] Negligence Per Se
[3] Strict Liability
[4] Statutory Product Liability Acts
[5] Breach of Warranties
[6] Wrongful Death
[7] Loss of Consortium
[8] Emotional Distress
[9] Economic Harms
- 11.02 Parties
[1] Alternative Liability
[2] Jurisdictional Implications of Choosing Certain Parties

- 12.01 Introduction
- 12.02 Defenses
[1] Failure to Prove Prima Facie Case
[2] Warranty Defenses
[3] Negligence Defenses
[4] Claims Unique to Retailers
[5] Defenses to Vendor and Supplier Claims

Proving Causation in Foodborne Illness Cases
- 13.01 General Principles of Causation in Foodborne Illness Cases
- 13.02 Specific Evidence of Causation in Foodborne Illness Cases
[1] Defendant s Recall as Evidence of Causation
[2] Common Exposure as Evidence of Causation
[3] Expert Testimony as Evidence of Causation
[4] Diagnostic Tests as Evidence of Causation
[5] Testing Surviving Food Samples
[6] Titer Testing
- 13.03 Epidemiology
[1] Epidemiological Links
[2] Statistical Modeling

Complex Foodborne Illness Litigation: Class Actions and Multidistrict Litigation
- 14.01 Class Actions
[1] Class Definitions
[2] The Four Threshold Requirements of Rule 23(a)
[3] Rule 23(b): the Three Categories of Class Actions
[4] Additional Features of Rule 23
- 14.02 Multidistrict Litigation
- 14.03 Coordination of State and Federal Litigation

Insurance and Indemnification
- 15.01 Introduction to Insurance Issues
- 15.02 Potential Losses Associated with Food Contamination
- 15.03 General Liability Policies
[1] Coverages
[2] Exclusions
[3] Third Party Coverage Under General Liability Policies
[4] Additional Insured Issues
[5] Punitive Damages
- 15.04 Specialized Coverage
[1] Product Recall Coverage
[2] Accidental Contamination Coverage
[3] Malicious Tampering Coverage
[4] Internal Risk Management
- 15.05 Indemnification
[1] Introduction
[2] Enforcement of Indemnification Obligations
[3] Drafting Indemnification Language
- 15.06 Waiver of Subrogation

Labeling Requirements
- 16.01 Introduction
- 16.02 The Regulatory Framework Governing Labeling
[1] FDA s Regulatory Labeling Scheme
[2] USDA s Regulatory Scheme
- 16.03 State Law Issues and Preemption
[1] Preemption Issues Arising Under the FDA s Regulatory Scheme
[2] Preemption by USDA Regulatory Scheme
- 16.04 Enforcement Actions
[1] FDA s Enforcement Actions
[2] USDA s Enforcement Actions
- 16.05 Public Pressure to Reform Labeling Regulation
- 16.06 Labeling Requirements and Guidelines
[1] Principal Display Panel
[2] Information Fact Panel and Nutrition Labeling
[3] Nutrient Content Claims
[4] Health Claims
[5] Front of Package Labeling and Use of Symbols
[6] USDA Regulations Unique to Meat and Poultry Labels

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James F. Neale

James F. Neale is a Partner in the Charlottesville, Virginia office of McguireWoods LLP. He serves as co-chair of the firms foodborne illness litigation practice group and has substantial mass tort and class action litigation experience. Mr. Neale has won verdicts in state and federal court trials and has briefed and argued before the Virginia Supreme Court and the U.S. Court of Appeals for the 4th Circuit. He has also written and spoken widely on food safety law and other issues.

A former U.S. Army Officer, Mr. Neale served as an Airborne Ranger and Light Infantry Platoon Leader and was awarded the Ranger Tab, Senior Parachutists Badge, Air Assault Badge, and Expert Infantrymans Badge. Mr. Neale received his J.D. in 1988 from the University of Virginia School of Law where he was the Winner and Outstanding Oralist in the William M. Lile Moot Court Competition and the recipient of other awards for oral and written advocacy. He clerked for the Hon. Richard L. Williams, Senior U.S. District Court Judge, Eastern District of Virginia. Mr. Neale is admitted to practice in Virginia and West Virginia and before a number of federal district and appellate courts.

Angela M. Spivey

Angela M. Spivey is a Partner in the Atlanta office of McguireWoods LLP. She has extensive experience in foodborne illness litigation and has defended manufacturers in toxic tort and asbestos, silica, and benzene claims in state and federal courts throughout the United States. Ms. Spivey also represents manufacturers of consumer products in product liability actions. Named a Georgia Super Lawyer Rising Star in Law & Politics, 2009, she has published and spoken widely on food safety law and other issues. Ms. Spivey received her J.D., magna cum laude, from University of Mississippi School of Law in 1996. She is admitted to practice in Georgia and Mississippi and before a number of federal district and appellate courts.
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