Know Your Food Suppliers New FSMA Responsibility, Liability, and Insurance

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1 Know Your Food Suppliers New FSMA Responsibility, Liability, and Insurance Christopher Van Gundy Partner San Francisco, CA Office Frederick A. Stearns Partner Washington, DC Office Arthur S. Garrett III Partner Washington, DC Office Copyright Keller and Heckman LLP 2

2 Strict Liability In The Food Chain Strict Liability Indemnity Agreements Good for adjoining link But still can be jerked in the chain Copyright Keller and Heckman LLP 3

3 Supply Chain Liability Example Copyright Keller and Heckman LLP 4

4 Traditional Supply Chain Liability Traditional Supply Chain Liability And Obligations FDA Warning Letters California s Proposition 65 Indemnity/Warranty Disputes Voluntary Recalls FTC Warning Letters/Administrative Actions NAD Actions Consumer Class Action Injury Lawsuits Copyright Keller and Heckman LLP 5

5 New Supply Chain Liability (cont d) New Supply Chain Liability and Obligations FDA/FSMA Foreign Supplier Verification Program Consumer Class Actions in Food Court Food Fraud/Food Contamination Recalls/Criminal Enforcement Competitor Lawsuits State Attorneys General Copyright Keller and Heckman LLP 6

6 New Supply Chain Liability Why Increased Scrutiny? Recalls/illness outbreaks almost weekly More government scrutiny/sophistication Rise of the Food Court Hungry Lawyers Copyright Keller and Heckman LLP 7

7 New Supply Chain Obligations FDA Food Safety Modernization Act (FSMA) The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years... aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. Copyright Keller and Heckman LLP 8

8 New Supply Chain Obligations (cont d) New Obligations For Importers Foreign Supplier Verification Program Processing consistent with U.S. food safety laws This means preventative controls Risk-based assessment of hazards Like HACCP Copyright Keller and Heckman LLP 9

9 FSMA Background Shifts regulatory focus from responding to contamination to preventing it; new requirements related to: Record inspection Hazard Analysis and Risk-based Preventive Controls (HARPC) Intentional adulteration Sanitary transportation of food Foreign Supplier Verification Program (FSVP) Copyright Keller and Heckman LLP 10

10 Final FSVP Rule Published on November 27, Fed. Reg Importation of food if importer does not implement FSVP is a prohibited act (FD&C Act 301(zz)) Rules affect both domestic importers and foreign suppliers to the U.S. market Copyright Keller and Heckman LLP 11

11 Who really needs to comply? Trigger for FSVP compliance is importation of food into the U.S. Food defined broadly to include raw materials, ingredients, and finished food Importer is defined as the U.S. owner or consignee of the article of food Where there is no such entity at the time of entry, the importer is the U.S. agent or representative of the foreign owner or consignee as confirmed in signed statement of consent Definition intended to ensure that entity with a financial interest in the food, and with knowledge about the supply chain, is responsible for FSVP compliance Copyright Keller and Heckman LLP 12

12 Who is exempt? Food subject to seafood, juice, and LACF HACCP requirements For LACF facilities, exemption applies only with respect to microbiological hazards Food imported for R&D purposes or for personal use Alcoholic beverages imported from certain foreign suppliers Food transshipped or imported for processing and export Food returned to the U.S. without further processing in a foreign country Certain meat, poultry, and egg products under USDA jurisdiction Importers that are HARPC-compliant facilities Copyright Keller and Heckman LLP 13

13 Who is exempt? (cont d) Importers of fruits and vegetables subject to Produce Safety rule Exempt from requirement to determine whether there are any biological hazards that require a control Foods for which hazard analysis identifies no hazards requiring a control Imported food that cannot be consumed unless the hazard is controlled or for which the hazard is not controlled until after importation Importers of dietary supplements subject to (and compliant with) certain supplement GMP requirements Very small importers and importers of food from certain small foreign suppliers Food imported from a country with an officially recognized U.S.-equivalent safety system Copyright Keller and Heckman LLP 14

14 FSVP Elements Conduct analysis of hazards reasonably likely to cause illness or injury with respect to an imported food Evaluate and approve foreign suppliers based on that hazard analysis, as well as other factors Conduct supplier verification activities Take corrective actions when appropriate to control a hazard Maintain records of FSVP activities All FSVP activities must be conducted by a qualified individual Must have training, education, or experience (or some combination) necessary to develop the FSVP Must not have any financial conflicts of interest that influence results of verification activities Copyright Keller and Heckman LLP 15

15 How to Achieve Compliance Importers comply with FSVP when they: 1. Comply with most of the HARPC supply chain provisions 2. Implement HARPC under the regulations for the hazards in the food they import 3. Are not required to implement HARPC under certain provisions (e.g., food that cannot be consumed without the application of a PC) Copyright Keller and Heckman LLP 16

16 Hazard Analysis Similar to HARPC framework, importers must document and conduct a hazard analysis for all known or reasonably foreseeable hazards to determine whether there is a need to implement any measures to control those hazards Final rule permits an importer to review another entity s hazard analysis, provided that a qualified individual conducts the analysis and the importer documents its review and assessment of that analysis Copyright Keller and Heckman LLP 17

17 Hazard Analysis (cont d) Hazards Biological, chemical, radiological, physical Naturally occurring, unintentionally introduced or intentionally introduced for economic gain Factors to consider when evaluating hazards include: Formulation of the food Conditions of the establishment that produces the food Transportation practices Packaging and labeling activities Intended use of the food Copyright Keller and Heckman LLP 18

18 Foreign Supplier Evaluation Food must be imported from foreign suppliers that have been evaluated and approved May be evaluated by the importer or another entity Foreign supplier includes establishment that manufactures or processes food or grows food exported to U.S. without further manufacturing or processing by another establishment Does not include entities involved with de minimis activity (e.g., holding or labeling) Copyright Keller and Heckman LLP 19

19 Foreign Supplier Evaluation (cont d) Evaluation must take into account: Hazard analysis Entities responsible for controlling hazards or verifying controls Could be foreign supplier or another entity Foreign supplier s food safety performance history Foreign supplier s food safety protocols and procedures Foreign supplier s compliance status under FDA or foreign regulations Importers must reevaluate their foreign suppliers at least once every three years Copyright Keller and Heckman LLP 20

20 Foreign Supplier Verification Establish and follow written procedures that verify food is only imported from approved suppliers and that hazards identified in imported food are appropriately controlled Appropriate verification activities may include: Onsite audits of foreign suppliers Must be conducted by qualified auditor (may be government employee) Consider applicable FDA food safety regulations or country with comparable system Substitute results from FDA inspector or food safety authority in comparable system Sampling and testing of food Review of foreign supplier s relevant food safety records Copyright Keller and Heckman LLP 21

21 Foreign Supplier Verification (cont d) Importer permitted to review another entity s verification activities provided that: Qualified individual conducted the verification; and Importer documents its review and assessment of that verification May use unapproved suppliers on temporary basis when subject food to verification Copyright Keller and Heckman LLP 22

22 Corrective Actions Take corrective actions if it is determined that Foreign supplier is producing food in a manner that does not provide the same level of public health protection as food in compliance with the HARPC or produce safety requirements, or Imported food is otherwise adulterated or misbranded Copyright Keller and Heckman LLP 23

23 Special Circumstances Foreign supplier approval and verification not needed in two cases: 1. Food cannot be consumed without application of control (e.g., coffee beans) 2. Hazard controlled by importer s customer or subsequent entity in U.S. distribution Disclosure statement not processed to control [identified hazard] Written assurance from customer annually Other system to ensure control of hazard applied at subsequent distribution step (disclosure to and written assurance from customer s customer) Copyright Keller and Heckman LLP 24

24 FSVP Records Importers must maintain related records for at least two years and provide records to FDA on request Can be stored in offsite location Do not need to be in English, but must provide English translation within a reasonable time upon FDA s request Time would depend on volume of records requested should not be so long as to impair the Agency s ability to conduct record reviews and follow-up enforcement activities Copyright Keller and Heckman LLP 25

25 What does compliance mean? Compliance is likely to mean different things to different entities in the supply chain There is no one size fits all approach to complying with FSVP or other FSMA requirements Compliance must be tailored to individual foods and facilities Common element = qualified individuals must implement compliance strategies across facilities Copyright Keller and Heckman LLP 26

26 Compliance Deadlines Revised GMPs & HARPC: September 19, 2016 FSVP: May 29, 2017 Food imported from a supplier subject to HARPC or produce safety regulations must be in compliance with FSVP requirements 6 months after the foreign supplier of the food is required to comply with applicable regulatory framework Copyright Keller and Heckman LLP 27

27 New Supply Chain Liability New Supply Chain Liability and Obligations FDA/FSMA Foreign Supplier Verification Program Consumer Class Actions in Food Court Food Fraud/Food Contamination Recalls/Criminal Enforcement Competitor Lawsuits State Attorneys General Copyright Keller and Heckman LLP 28

28 New Supply Chain Liability (cont d) Consumer Class Actions in The Food Court Consumer Deception Natural GMO PHO Organic Copyright Keller and Heckman LLP 29

29 New Supply Chain Liability (cont d) Food Court Hundreds of Cases Federal courts in San Francisco and Los Angeles Purported Class Actions Rapidly developing area of the law Unique to food Few appellate decisions Some big settlements Copyright Keller and Heckman LLP 30

30 New Supply Chain Liability (cont d) Food Contamination/Fraud Cumin Extra virgin olive oil Peanuts/spinach/cantaloupe Recalls Today Lost property, profits, goodwill Injured consumer liability Criminal liability/park Doctrine Copyright Keller and Heckman LLP 31

31 New Supply Chain Liability (cont d) Competitor Lawsuits Consumer deception Copycat consumer lawsuits State Attorneys General Consent orders No warnings Shaky science Copyright Keller and Heckman LLP 32

32 Insurance Overview Coverage will depend on the type of liability: Lanham Act Claim (false designation of origin, false description) California CLRA Claim (deceptive advertising) Breach of Contract Claim (economic loss) Bodily Injury Claim (consumer injured) Property Damage Claim (fraudulent food ingredient inextricably intertwined in food product) Copyright Keller and Heckman LLP 33

33 Insurance Policies Third-Party Liability Policies CGL Policy D&O Policy E&O (media)/professional Liability Policy First-Party Policies Property Insurance Specialized Recall Policy (Product Contamination Insurance) Copyright Keller and Heckman LLP 34

34 Competitor Claim Lanham Act - False Advertising Claim CGL Policy Coverage for Advertising Injury Misappropriation of Advertising Idea Infringement of Another s Slogan Disparagement of Another Product Exclusions (nonconformity, violation of statute) D&O E&O (media) Copyright Keller and Heckman LLP 35

35 California Consumer Claim CGL Policy Coverage for Advertising Injury Misappropriation of Advertising Idea Infringement of Another s Slogan Disparagement of Another Product Exclusions (nonconformity, violation of statute, knowledge of falsity) D&O wrongful act E&O (media) coverage for errors and omissions in content Copyright Keller and Heckman LLP 36

36 Breach/Contract (Economic Loss) CGL Policy Has to be Bodily Injury or Property Damage Does not Cover Breach of Contract Exclusions (recall exclusion, warranty exclusion) D&O/E&O Recall Policy 3rd-Party Liability Copyright Keller and Heckman LLP 37

37 Bodily Injury Claim BI Claim Injury due to ingestion of cumin cut with almonds or melamine in baby food. CGL Policy Defense and Indemnity May not cover emotional distress D&O/E&O (BI exclusions) Copyright Keller and Heckman LLP 38

38 Property Damage Claim PD Claim - Fraudulent food ingredient inextricably intertwined in food product. CGL Policy (defense and indemnity) Property Policy (first-party) contaminated stock Copyright Keller and Heckman LLP 39

39 THANK YOU Christopher Van Gundy Partner Frederick A. Stearns Partner Arthur S. Garrett III Partner Washington, DC Brussels San Francisco Shanghai Paris Copyright Kellerand andheckman HeckmanLLP LLP Keller 40