navigating the u.s. fda foreign supplier verification
TRANSCRIPT
Navigating the U.S. FDA Foreign Supplier Verification
Program (FSVP) Rule
Presented by: Bracey Parr
Regulatory Specialist February 28nd, 2018
Presentation Overview
• FDA Basics
• Preventive Controls Rule
• Foreign Supplier Verification Program Rule
• Summary / Questions & Answers
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FDA Basics
A quick review
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How does the FDA work?
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• 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
How does FDA work?
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• Enforcement – Inspections
– Import Refusals
– Import Alerts
–Warning Letters
–Suspension of registration
–Civil and criminal penalties
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)
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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
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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
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Nutrition Labeling Requirements
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Preventive Controls Rule
“HARPC”
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Preventive Controls
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Food Safety
Plan
Preventive Controls
• Preventive Controls Qualified Individual
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Food Safety
Plan
Hazard Analysis
Preventive Controls
Supply Chain
Program
Recall Plan
Verification
Monitoring Procedures
Corrective Action
Recordkeeping
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
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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
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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
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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
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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…
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Foreign Supplier Verification Program
“FSVP”
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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
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FSVP – Written Progam
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Foreign Supplier Verification
Program
FSVP
• Qualified Individual
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FSVP
Hazard Analysis and Evaluation
Supplier Evaluation and
Approval
Appropriate Supplier
Verification Activities
Corrective Actions
Recordkeeping
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.
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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
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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
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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
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FSVP
• Additional exemption:
– Countries with officially recognized or equivalent food safety system • Food not intended for further processing
• New Zealand, Australia, and Canada
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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
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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
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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
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FSVP
• New information required in the Automated Commercial Environment
– Name of FSVP importer
– E-mail address
– Unique facility identifier
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Important Questions
• How will FDA monitor compliance?
– Audits of importer’s records
– Inspections of shipments in port
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Important Questions, cont.
• Consequences for non-compliance? – Import alerts
– Import detentions and refusals
– FDA Warning Letters
– Civil and criminal charges
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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!
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Summary / Questions & Answers
Registrar Corp’s solutions.
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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
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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
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Registrar Corp’s Solutions
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• 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
FSMA Compliance Wizard
• Go to www.fsmawizard.com to assess your requirements under FSMA free.
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Questions & Answers
Let us be your resource on FDA regulation.
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Contact Us
Registrar Corp Headquarters
144 Research Drive
Hampton, Virginia
USA 23666
P: +1-757-224-0177
F: +1-757-224-0179
www.registrarcorp.com
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