Navigating the U.S. FDA Foreign Supplier Verification Program (FSVP) Rule. Presented by: Bracey Parr Regulatory Specialist February 28 nd, 2018

Transcription

1 Navigating the U.S. FDA Foreign Supplier Verification Program (FSVP) Rule Presented by: Bracey Parr Regulatory Specialist February 28 nd, 2018

2 Presentation Overview FDA Basics Preventive Controls Rule Foreign Supplier Verification Program Rule Summary / Questions & Answers 2

3 A quick review FDA Basics 3

4 How does the FDA work? Common myths 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 4

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

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) 6

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 7

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 8

9 Nutrition Labeling Requirements 9

10 HARPC Preventive Controls Rule 10

11 Preventive Controls Food Safety Plan 11

12 Preventive Controls Preventive Controls Qualified Individual Recordkeep ing Hazard Analysis Preventive Controls Corrective Action Food Safety Plan Supply Chain Program Monitoring Procedures Verification Recall Plan 12

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 13

14 Preventive Controls Deadlines Food Safety Plan Facilities with >500 full-time equivalent employees: September 19 th, 2016 Small business (<500 employees): September 18 th, 2017 Qualified facility attestation Qualified facilities and very small businesses: September

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 15

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 16

17 Manufacturing Facility To Do 1. Designate a PCQI (either attend class or justify experience & education) 2. Build and implement a HARPC Plan 3. Complete your Supply Chain Program (if necessary) 4. Document, document, document 17

18 FSVP Foreign Supplier Verification Program 18

19 FSVP Principles behind the rule Importers share responsibility for ensuring safety of imported food Risk-based Flexibility in meeting requirements Alignment with PC supplychain provisions 19

20 FSVP Written Progam Foreign Supplier Verification Program 20

21 FSVP Qualified Individual Hazard Analysis and Evaluation Recordkeeping FSVP Supplier Evaluation and Approval Corrective Actions Appropriate Supplier Verification Activities 21

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. 22

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 23

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 24

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 No supplier evaluation, no verification activities (Hazard Analysis still required) Written assurances 25

26 FSVP Additional exemption: Countries with officially recognized or equivalent food safety system Food not intended for further processing New Zealand, Australia, and Canada 26

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 27

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 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

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

30 FSVP New information required in the Automated Commercial Environment Name of FSVP importer address Unique facility identifier 30

31 Important Questions How will FDA monitor compliance? Audits of importer s records Inspections of shipments in port 31

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

33 Foreign Supplier Verification Program To do 1. Designate a QI (justify education & experience) 2. Review foreign suppliers HARPC Food Safety Plan for compliance/document exemptions 3. Build a Foreign Supplier Verification Program for each product category from each supplier 4. Monitor your suppliers for FDA Compliance 5. Document, document, document! 33

34 Registrar Corp s solutions. Summary / Questions & Answers 34

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 Companies <500 employees: Sept

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 36

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 37

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

39 FDA Compliance Monitor Free compliance report 39

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

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