1. Presented by: Bracey Parr Regulatory Specialist February 28nd, 2018
Navigating the U.S. FDA Foreign Supplier Verification Program (FSVP) Rule
Presented by:
Bracey Parr
Regulatory Specialist
February 28nd, 2018
Good morning everyone and thank you ____ for that introduction.
It’s a real pleasure to be with y’all this morning to discuss a very interesting and hot topic in the food manufacturing industry: the Food Safety Modernization Act and particularly Foreign Supplier Verification Program.
As a general service announcement before we begin, I will be using FSMA as a acronym for the Food Safety Modernization Act and FSVP to refer to the Foreign Supplier Verification Program.
Also, if you think of a question and don’t want to forget it during the presentation portion of our time together, you can type it in the chat box to your lower left and I will answer during our question and answers session. I may take relevant questions at various times to underline a point, too.

2. Presentation Overview
FDA Basics
Preventive Controls Rule
Foreign Supplier Verification Program Rule
Summary / Questions & Answers
During this hour today, you will be glued to the edge of your seat as we discuss:
How the FDA works, what the FDA means for an importer
The rational behind the FSMA
The Preventive Controls rule as it applies to the facilities from which you source – important to understand before getting to FSVP
The Foreign Supplier Verification Program rule
Lastly, we will have a quick summary as well as a Q&A

3. FDA Basics A quick review
Now we’ll turn briefly to one of the two most important rules under the law, the Preventive Controls Rule

4. How does the FDA work? Common myths For food and beverages
FDA “approves” facilities
FDA “approves” products
FDA requires submissions of labels or an inspection before marketing products
For food and beverages
Regulator / Rulemaker
Enforcer / Police

5. How does FDA work? Enforcement Inspections Import Refusals
Import Alerts
Warning Letters
Suspension of registration
Civil and criminal penalties

6. Food Facility Registration
Registration required under the Bioterrorism Act of 2002 for facilities that manufacture, process, pack or store food (including beverages and dietary supplements)
Under the Bioterrorism Act, all facilities, foreign and domestic, that take physical possession of food that is intended for human or animal consumption in the United States must register with FDA. Registration is not a permit or approval; it is simply the act of providing your facility’s information to FDA so that the agency can reach you in the event of a food-related emergency. Foreign facilities must designate a US Agent to manage routine and emergency communication with FDA.

7. U.S. Agent Non-U.S. facilities must designate a U.S. Agent
Verification step
Knowledge
Responsibilities
Coordinate an FDA inspection
Respond to FDA actions and communications 24/7
Pay FDA re-inspection fees
FDA’s Final Rule for Food Facility Registration includes 2 verification steps. For foreign facilities, FDA will send an to the designated US Agent with a receipt code. The US Agent must access FDA’s Unified Registration and Listing System (FURLS), navigate the interface, submit the receipt code, and agree to the US agent designation. For facilities whose registrations, renewals, updates or cancellations are submitted by an authorized third party, FDA will send an to the owner, operator or agent in charge of the facility with a receipt code. The owner, operator or agent in charge of the facility must access FDA’s Unified Registration and Listing System (FURLS), navigate the interface, submit the receipt code, and agree that the third party submission is authorized.
FDA believes that these verification steps will aid the agency to verify that the individual submitting the registration information is authorized to do so and that a US Agent is not designated without consent.

8. Prior Notice Notification to FDA NOTE: Required even for samples
Detention in port if not filed
Includes information about the shipment and the facility
May be filed by exporter, importer, or third party

9. Nutrition Labeling Requirements

10. Preventive Controls Rule
“HARPC”
Preventive Controls Rule
Now we’ll turn briefly to one of the two most important rules under the law, the Preventive Controls Rule

11. Food Safety Plan Preventive Controls
What must these suppliers do, then? What is the core concept of the Preventive Controls Rules?
The most important take-away from this section on the Preventive Controls for Human Food Rule is that all facilities that manufacture, process, pack, or hold food for consumption in the United States must write and implement a Food Safety Plan that covers all the products to be consumed in the U.S.
Many foreign suppliers have BRC, ISO 22,000, GFSI, HACCP, etc.
This is a new standard – currently none of these auditing schemes cover Food Safety Plans
If a company chooses to rely on a non-FDA mandated food safety scheme and does not create a Food Safety Plan per FDA requirements, there may be regulatory action from the FDA, including warning letters, detentions in port of entry, suspension of registration (essentially prohibiting the company from distributing food into commerce), import alerts, etc.

12. Monitoring Procedures
Preventive Controls
Preventive Controls Qualified Individual
Food Safety Plan
Hazard Analysis
Preventive Controls
Supply Chain Program
Recall Plan
Verification
Monitoring Procedures
Corrective Action
Recordkeeping
Additionally, this Food Safety Plan must be written by a Preventive Controls Qualified Individual (PCQI)
An individual who has successfully completed the standardized FDA training to become a PCQI or be otherwise qualified through job experience
What components does this Food Safety Plan include?
Hazard Analysis – The facility must perform a hazard analysis to identify all known and foreseeable biological, chemical (including radiological), and physical hazards, including intentional adulteration for economic gain, and to evaluate their likelihood of occurrence and assess the severity of the illness or injury if the hazard is not controlled
Preventive Controls – Controls that will prevent or minimize the identified hazard, includes process controls, food allergen controls, sanitation controls, supply chain controls, recall plan, etc.
Supply Chain program – A program that includes the supply chain controls you must carry out to verify that your suppliers’ are in compliance with the FDA and that the food they provide you with is not misbranded or adulterated
Recall plan – a comprehensive plan of what to do in case of an outbreak
Preventive Control management components (supply chain and recall plan do not have these components)
Verification – the verification that the controls are implemented and effective in controlling the identified hazards, including reanalysis every three years of the entire system as a whole
Monitoring – written procedures for monitoring the preventive controls and the frequency with which they’re performed
Corrective actions – written procedures that must be taken if a preventive control is not properly implemented
Recordkeeping – regulation varies, must keep most FSNA records for a minimum of two years after record creation

13. Preventive Controls Exemptions and modified requirements:
Retail establishments (restaurants and stores)
Qualified facilities
Juice and Seafood HACCP
Alcoholic beverages
Dietary supplements
USDA products
Farms
Unexposed, packaged food in warehouses
Who is required to comply?
Exemptions
Qualified facilities – either a “very small business” (less than 1 million USD in global food sales and inventory) or less than $500,000 in total food sales with more than 50% of sales to local consumers and local businesses

14. Preventive Controls Deadlines
Food Safety Plan
Facilities with >500 full-time equivalent employees: September 19th, 2016
Small business (<500 employees): September 18th, 2017
Qualified facility attestation
Qualified facilities and very small businesses: September 2018
When are food manufacturers, processors, packers, and holders required to comply?
Large businesses
Small business: <500 full time equivalent employees (calculated based on number of total labor hours)
Don’t get confused – although qualified facilities and VSB have a deadline – it’s only for modified requirements under the rule – submitting a written attestation to FDA

15. Important Questions How do we know a supplier has a Food Safety Plan?
FSVP and supplier verification activities!
Must we keep a supplier’s Food Safety Plan on file?
Not necessarily – review is essential though
FSVP should suffice for U.S. customers
How will FDA enforce this requirement?
Audit of importers
Facility inspections
Inspections in port
Now that we’ve got an idea what this regulation requires, I want to answer some questions pertinent to your business…

16. Important Questions, cont.
What are the consequences for failure to comply?
FDA Warning Letters
Import Alerts
Detentions and Refusals in Port
Suspension of registration
Civil and criminal charges
Collateral damage to company image

17. Manufacturing Facility
To Do
Designate a PCQI (either attend class or justify experience & education)
Build and implement a HARPC Plan
Complete your Supply Chain Program (if necessary)
Document, document, document…
To review … if you have a manufacturing facility, or you assist a manufacturing facility greatly …

18. Foreign Supplier Verification Program
“FSVP”
Foreign Supplier Verification Program

19. FSVP Principles behind the rule
Importers share responsibility for ensuring safety of imported food
Risk-based
Flexibility in meeting requirements
Alignment with PC supply-chain provisions
Requires importers to share responsibility for ensuring safety of imported food
Risk-based (according to types of hazards, importers, and suppliers)
Flexibility in meeting requirements (assessing activities conducted by others, exemptions, modified requirements, relying on existing records)
Alignment with PC supply-chain provisions

20. Foreign Supplier Verification Program
FSVP – Written Progam
Foreign Supplier
Verification
Program
What is the core requirement in this law?
Importer must have a Foreign Supplier Verification Program, or FSVP, for each product they import from each supplier
This FSVP will assist the importer in providing assurance that the foreign food manufacturer is producing food to the same standards as US FDA regulation

21. FSVP Qualified Individual
Hazard Analysis and Evaluation
Supplier Evaluation and Approval
Appropriate Supplier Verification Activities
Corrective Actions
Recordkeeping
An FSVP must be written by a Qualified Individual (PCQI)
Must have education, training, or experience (or combination thereof) necessary to perform the activity
Must be able to read and understand the language of any records reviewed in performing an activity
What components does this FSVP include?
Hazard Analysis – Hazard identification, and evaluation of the probability it will occur along with the probable severity of impact; consider the formulation of the food, transportation practices, packaging and labeling activities, storage and distribution and severalother factors
Foreign Supplier Evaluation, Approval, and Verification Procedures – look at the risk posed by the food (Hazard Analysis) + foreign supplier performance (look for FDA compliance history, compliance with FDA regulations), approve suppliers on the basis on the evaluation
Verification activities – Establish and follow written procedures to ensure you only import food from foreign suppliers you have approved based on the evaluation conducted in the prior step (and when necessary and appropriate, on a temporary basis, you can use an unapproved supplier); establish procedures to verify that the hazards requiring a control (recall the food safety plan language) have been significantly minimized or prevented; determine these activities, could include onsite audits, sampling and testing, review of records; CAN RELY ON OTHER ENTITIES’ DETERMINATIONS FOR THIS STEP
Corrective actions: document any corrective action, you see a supplier is non-compliant, may include not using them
Record keeping: any activity related to FSVP – minimum two years

22. FSVP Who must comply? “Importer”: defined as owner or consignee
If there is no US owner or consignee, the “Importer” is the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent.
A very important part of figuring out FSMA is determining exactly who must write the FSVP
FDA defines the importer for FSVP purposes (or the FSVP importer) as the owner or final consignee; really, they want the company with the deepest financial interest in the food to take responsibility for this FSVP – if an importer owns the food that is going to enter a third-party warehouse, the importer is responsible for the FSVP, not the third-party warehouse
If there is no US owner or consignee (read rest) … can be case for Canadian/Mexican importers that own the food as foreign importers
DIFFERENT THAT IMPORTER OF RECORD – Importer of record is used for Customs and Border Patrol purposes and figuring customs duties

23. FSVP Exemptions for certain foods
Firms subject to juice or seafood HACCP regulations
Food for research or evaluation
Food for personal consumption
Alcoholic beverages and ingredients (when importer uses them to make an alcoholic beverage)
Food transshipped through U.S.
Food imported for processing and export
“U.S. food returned”
Meat, poultry, egg, and catfish products subject to USDA regulation at time of importation
For which products must you write an FSVP?
Basically for any facility that requires a Food Safety Plan (most cases)

24. FSVP Exemptions for receiving facilities
Receiving facilities – facility that manufacture or processes an ingredient or raw material from a supplier
Implement Preventive Controls at the facility
Compliance with risk-based supply chain
For which products must you write an FSVP?
Basically for any facility that requires a Food Safety Plan (most cases)

25. FSVP Exemptions for certain commodities
Green coffee, certain grains, cacao
No supplier evaluation, no verification activities (Hazard Analysis still required)
Raw materials with hazards controlled after import
Written assurances

26. FSVP Additional exemption:
Countries with officially recognized or equivalent food safety system
Food not intended for further processing
New Zealand, Australia, and Canada
Importing from countries with an officially recognized or equivalent food safety system have an additional exemption
Only for food not intended for further processing –
Only must verify compliance with local food authority
ROUNDABOUT WAY – EXEMPT FROM FOOD SAFETY PLAN REQUIREMENT

27. FSVP Very Small Importer (VSI) – Exempt from most requirements
Less than $1 million/yr. in human food sales and inventory
Less than $2.5 million/yr. in animal food sales and inventory
Food from certain small suppliers – Certain requirements still apply
Qualified facility (same $ as VSI)
Produce from certain small suppliers that are not covered farms
Shell egg producers with < 3,000 laying hens
Additional exemptions for FSVP include:
VSP importer – I don’t believe this applies to TRI, possibly some suppliers

28. FSVP
When must I comply?
Latest of these dates
Implement an FSVP for suppliers subject to the Preventive Controls deadline (Food Safety Plan) of Sept. 2016
May 2017
Implement an FSVP for suppliers subject to other Preventive Controls deadlines (small businesses, qualified facilities, etc.)
Six months following the supplier’s compliance date
E.g., Small business supplier – Food Safety Plan deadline of Sept. 2017, so FSVP deadline March 2018

29. FSVP
When must I comply?
Importer subject to supply-chain program in the Preventive Control regulations
Date the importer must comply with those supply-chain provisions

30. FSVP New information required in the Automated Commercial Environment
Name of FSVP importer
address
Unique facility identifier
FSVP also requires that importers identify themselves at the point of entry…
ACE is going to be the “one window” filing system – your broker will have to enter this info
This is how FDA will keep track of who is responsible for FSVP obligations
This includes giving the FSVP importer’s name, address, and Unique Facility Identifier, which the FDA has indicated as a DUNs number for importers

31. Important Questions How will FDA monitor compliance?
Audits of importer’s records
Inspections of shipments in port
Now to round it out and answer some important questions…

32. Important Questions, cont.
Consequences for non-compliance?
Import alerts
Import detentions and refusals
FDA Warning Letters
Civil and criminal charges

33. Foreign Supplier Verification Program
To do
Designate a QI (justify education & experience)
Review foreign suppliers HARPC Food Safety Plan for compliance/document exemptions
Build a Foreign Supplier Verification Program for each product category from each supplier
Monitor your suppliers for FDA Compliance
Document, document, document!

34. Summary / Questions & Answers
Registrar Corp’s solutions.
Summary / Questions & Answers
We’ll move on to the last part of our presentation today, a quick summary and then time for questions

35. Summary Preventive Controls Rule Obligations
FDA-registered food facility
Food Safety Plan
Written by preventive controls qualified individual
Deadlines for subject facilities
Companies >500 employees: Sept. 2016
Companies <500 employees: Sept. 2017
In essence, the two most important rules in the regulation concerning TRI are the preventive controls rule and the Foreign Supplier verification program
First, your suppliers must ascertain what their obligations are under the rule…
If they are producing food, which includes food additives and GRAS substances…FOOD SAFETY PLAN

36. Summary FSVP Obligations Importer
U.S. owner or consignee
Foreign Supplier Verification Program
Written by qualified individual
Deadlines (latest) for subject importers
Suppliers with deadline in Sept. 2016: May 2017
Suppliers with further deadlines: Six months after
Importer is manufacturer: Deadline for supply-chain

37. Registrar Corp’s Solutions
Registrar Corp provides a full range of fixed-fee compliance services:
Registration & U.S. Agent Service
Prior Notice Filings
Label, Ingredient, and Product Review
LACF and Food Safety Services (Mock FDA Inspections)
FSMA Compliance Services
Detention Assistance
DWPE Petition Submissions
FDA Compliance Monitor

38. FSMA Compliance Wizard
Go to to assess your requirements under FSMA free.

39. FDA Compliance Monitor
Free compliance report

41. Let us be your resource on FDA regulation.
Questions & Answers

42. Contact Us
Registrar Corp Headquarters 144 Research Drive Hampton, Virginia USA P: F: