1. Foreign Supplier Verification & Voluntary Qualified Importer Programs
Food Law Current Issues Seminar
Michigan State University; July 12, 2016

2. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
FSMA Cornerstones
Preventive Controls (Human and Animal Food)
Produce Safety
Foreign Supplier Verification
Voluntary Qualified Importer Program
Accreditation of Third Party Auditors
Certification of Foreign Facilities/Foods
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

3. GMA Four Pillars (September 2007)
Mandatory Foreign Supplier Quality Assurance Program
Voluntary Qualified Importer Food Safety Program
Building Capacity of Foreign Governments
Expand the Capacity of FDA
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

4. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

5. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
FSVP Basics
Importers must develop, maintain, and follow an FSVP for each food imported, unless exempt
Elements and requirements of FSVP vary
Type of food
Category of importer (very small, for ex)
Nature of hazard
Who is to control hazard
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

6. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Exemptions
Importation of juice and seafood whose suppliers are in compliance with HACCP regulations
Food imported for research and evaluation
Food imported for personal consumption
Alcoholic beverages
Food that is transshipped or imported for future export and not consumed or distributed in the US
Products from facilities subject to FDA low acid canned food requirements (exempt as to microbiological hazards only)
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

7. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Who is the Importer?
“Importer” – The US owner or consignee of the food offered for import
“US owner or consignee” – The person in the US who, at the time of entry, owns the food, has purchased the food, or has agreed in writing to purchase the food
If no US owner or consignee, the importer is the US agent or representative of the foreign owner or consignee
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

8. What is a Foreign Supplier?
“Foreign supplier” – The establishment that manufactures/processes the food, raises the animal, or grows the food (without further manufacturing/processing of more than a de minimis nature)
“Food” – as defined in the FD&C Act -- raw materials, ingredients, finished food and food contact substances (but not pesticides)
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

9. Basic FSVP Requirements
Conduct hazard analysis for imported food
Evaluate the risk posed by a food – based on the hazard analysis and the foreign supplier’s performance
Using evaluation, approve (or not) suppliers
Determine appropriate supplier verification activities
Conduct supplier verification activities
Conduct corrective actions
Maintain records
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

10. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Some Nuances
Each food and each supplier require a FSVP
One hazard analysis for different foods of same type from a single foreign supplier, if those foods have similar hazard profile
Evaluation of risk and supplier’s performance must be re-evaluated every three years or when you acquire new information about a potential hazard or the supplier’s performance
No FSVP required if importer has adequate assurances that a subsequent entity (importer’s customer, for example) will process the food for food safety. Documents accompanying the food must disclose (“not processed for microbiological safety”)
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

11. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
More nuances
No FSVP required if importer has adequate assurances that a subsequent entity (importer’s customer, for example) will process the food for food safety. Documents accompanying the food must disclose (“not processed for microbiological safety”)
And, annually obtain from customer a written assurance
An importer can rely on another entity to conduct the hazard analysis.
“Other entity” cannot be the foreign supplier
Importer must review and assess the “relevant documentation”
No evaluation or supplier verification required if there are no hazards to control
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

12. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Hazard Analysis
Assessment -- based on experience, illness data, scientific reports, and other info – about the known or reasonably foreseeable hazards
Hazards –
Biological
Chemical
Physical
Includes naturally occurring hazards, unintentionally introduced hazards, and intentionally introduced hazards
Probability and severity
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

13. Scope of Hazard Analysis
Formulation
Condition, function, design, of the establishment and equipment of a typical entity that produces the food
Raw materials/ingredients
Transportation
Harvesting, raising, manufacturing, processing, packing, packaging and labeling
Storage and distribution
Likely use
Sanitation
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

14. Evaluation of Food and Supplier Performance
Hazard Analysis
Entity controlling the hazards (supplier or supplier’s raw material supplier, for example)
Foreign supplier’s procedures, processes, and practices related to food safety
Applicable FDA regulations and supplier’s compliance history (FD 483, warning letters, import alerts)
Supplier’s food safety history (testing, audits, corrective actions)
Storage and transportation practices
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

15. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Approved Suppliers
Importer must have – in writing – written procedures to ensure that it imports only from approved suppliers and it must conduct appropriate verification activities
Unapproved supplier can be used temporarily, provided food is subjected to verification activities before importation
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

16. Supplier Verification
Importers should tailor verification activities to food and supplier (not one size fits all)
Purpose of verification activities: provide assurance that the hazards requiring control are significantly minimized or prevented
Importer must establish and implement written procedures to ensure verification activities occur
Examining written procedures is where FDA inspection typically begins
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

17. What are Verification Activities?
Annual onsite audits
Required where there is reasonable probability that exposure to a hazard controlled by the supplier will result in serious adverse health consequences or death to humans or animals (SAHCODHA)
Unless the importer documents that an alternative approach to verification is appropriate and provides assurance that the food meets US standards
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

18. More Verification Activities
Sampling and Testing
Review of foreign supplier’s food safety records
Other appropriate verification activities
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

19. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
On-Site Audits
Must be conducted by qualified auditor
Audit not subject to Third-Party Certification Body rule
If food is subject to FDA food safety regulations, audit must consider those regulations and review foreign supplier’s food safety plan (including implementation)
GFSI audit – not presumptively compliant
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

20. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
More On-site Audits
In lieu of on-site audit, importer may rely on a food safety inspection by:
FDA
Other federal, state, local, tribal or territorial agency
Food safety authority of country whose food safety system has been recognized by FDA as comparable/equivalent to the US system (NZ/Canada)
If, the inspection is done within one year of the date the onsite audit would have been required
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

21. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Corrective Actions
Corrective actions are required when –
Importer determines foreign supplier has not used processes and procedures to provide same level of public health protection as FDA rules
Supplier produced food that was adulterated or misbranded with respect to allergen labeling
If importer learns of supplier problems by means other than verification activities or re-evaluation of foreign supplier, investigation is required to determine if FSVP needs modifying
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

22. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Entry Process
Importer must provide, for each line entry (to U.S. Customs and Border Protection (CBP)):
Importer’s name
Importer’s address
Unique facility identifier acceptable to FDA (DUNS number for facility where FSVP records are maintained)
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

23. Importer Identification
FDA will create list of FSVP importers to be posted on its website
Importer information used for inspectional purposes
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

24. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Recordkeeping
Critically important
Virtually everything related to FSVP (and FSMA more generally) must be recorded
Records must be available to FDA upon request during inspection and submitted to FDA on request (remote request) promptly
English translation will be required for records requested
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

25. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Who Can Do a FSVP?
Only qualified individuals may develop an FSVP and a QI must perform all required FSVP tasks
QI is someone who has training, education, or experience (or some of each) necessary to perform a particular FSVP activity
QI must be able to read and comprehend foreign language records
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

26. Auditor Qualifications
Qualified auditor must be used to conduct onsite audit of foreign supplier
QA must have education, training and/or experience and some actual audit experience
Could be foreign government official
Agent of accredited third-party certification body
May not be an employee of the foreign supplier (obvious conflict of interest; beware the supplier’s “brother-in-law”)
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

27. Modified Requirements
Very small importers
Food from small foreign suppliers
Food from foreign supplier in country with an officially recognized or equivalent food safety system
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

28. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Compliance Dates
Importers must comply by latest of:
May 27, 2017 (18 months after publication of rule)
If foreign supplier is subject to preventive controls or product safety rule, 6 months after compliance for that rule is required
If importer is “receiving facility,” the date the importer is required to comply with the supply chain provisions in the preventive controls rule
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

29. Voluntary Qualified Importer Program
The HOV lane for importers (maybe)
Draft guidance for VQIP (June 2015)
How will program work
How can importers qualify?
Voluntary program (user fee)
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

30. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
VQIP Definitions
Importer – person that brings food or causes food to be brought from foreign country into customs territory of the US (unlike FSVP, can be located outside US)
Foreign supplier – same definition as FSVP
Food – excludes pesticides and food contact substances
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

31. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Eligibility for VQIP
3-year history of importing food into US
Current facility certification for each foreign supplier (by accredited third-party certification body)
No food importer imports (whether in or out of VQIP) subject to import alert or Class I recall
Annual fee payable by October 1
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

32. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
More Eligibility
Neither importer nor non-applicant entities are subject to an ongoing FDA administrative or judicial action (import alert, injunction, debarment) or have history of noncompliances related to food safety (OAI inspection with no corrective action taken)
No CBP penalties, forfeitures, sanctions related to safety of security of FDA-regulated products during prior three years
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

33. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
Even More Eligibility
FSVP or HACCP importer in compliance with supplier verification requirements
Importer must use paperless filers/brokers with passing rating during last FDA Filer Evaluation
Importer must have VQIP quality assurance program (QAP) (QAP documentation accompanies VQIP application)
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

34. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
What Goes in a QAP?
Corporate policy statement related to food safety and security (supply chain wide)
Organizational structure/management structure for QAP
Food safety policies and procedures
Food defense policies and procedures
Training and experience requirements for employees responsible for QAP
Procedures to ensure QAP implementation
Procedures for record maintenance
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

35. VQIP Annual Application
Annual notice of intent between January 1 and May 31
Importer application, QAP, labels of each food under VQIP
Annual fee paid by October 1
Importer must promptly amend application for changes (food, supplier, broker, label, etc.)
Identify food as VQIP at entry
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

36. FDA Identified Benefits
Expedited entry
FDA will not examine/sample VQIP entries except for cause, as part of surveillance, and as part of VQIP audit
FDA will examine/sample at importer’s preferred location
FDA will expedite analysis of for cause & audit samples
FDA will assist with CBP if exportation is required
FDA VQIP Help Desk
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

37. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016
VQIP – Worth it?
Not clear from comments that VQIP is likely to succeed or garner sufficient participation
Timing
Final guidance – summer 2016?
Fee schedule August 2018
First applications – January 2018
First fiscal year for benefits – October 2018
Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016

38. Stuart M. Pape, Polsinelli / FSVP & VQIP /July 2016