| Date post: | 13-Apr-2017 |
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Food |
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FSMA CLUB“Trust, but Verify”
Tips & Tools for FSMA’s Foreign Supplier Verification
Marc Sanchez, FDA Attorney & FounderContract In-House Counsel & Consultants, LLC
andGary Nowacki, CEO
TraceGains, Inc.
Gary NowackiCEOTraceGains
Marc Sanchez, Esq.FounderContract In-House Counsel & Consultants LLC
Foreign Supplier Verification
ProgramTrust, Verify, and
Verify Again
Marc C. Sanchez, Esq.www.fdaatty.com
Who Me?Who is an “importer”?
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Importer Person who purchased the food being
imported.
No U.S. Owner?
Then the importer is the consignee.
No Owner or Consignee?Then the importer is the U.S. Agent
When in DoubtWho has the financial interest and control over the supply chain?
ExemptionsLimited and Narrow Exemptions
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JuiceSubject to HACCPVerify HACCP Compliance
Research Use Only“research and evaluation purposes”
Alcoholic BeveragesATTB Retains JurisdictionPermitting process unchanged
Seafood Subject to HACCPSubject to HACCP
Verify HACCP Compliance
Personal Consumption Transshipped Foods
LACFMicro Hazards ONLY
How much is really exempt?
New Safety Standards
Verification
FSMA FrameworkFSMA Relies on NEW Safety Standards and Industry Verification of Compliance
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Integrating suppliers, importers, and importer’s customers
Standards in two categories: produce safety and hazard
analysis /preventative controls
Contents of a Verification ProgramA FSVP Generally Consists of 6 Parts
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ComplianceSupplier Compliance
History Food Requirements (Sec. 303)
Hazard AnalysisSimilar to HACCP +
“reasonably likely to occur”
Verification
Testing, on-site audit, etc.
CAAdapting FSVP and correcting hazard analysis or verification
activities in response to issues.
Assessment
Not a set it and forget it program
RecordkeepingEven the exemptions and
modified requirements require documentation!!
Modified Requirements Requires Careful Review and Application
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Dietary Supplements Finished vs BulkFinished subject to most of FSVP. Bulk/Components Subject to Part 111 with a little FSVP.
“Very Small”Supplier OR ImporterDocument AnnuallyQualification (<$500k food sales).
FDA Approved CountryA list of approved countriesCanada? Japan? t/b/d
Control and Type of HazardHazard Analysis Informs Verification Activities
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Importer Controls the HazardThis Means No Recipient for Further Processing
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Import Raw NutsImported food untreated
and not subject to an exemption
Hazard Analysis
Salmonella likely to be present at some level
VerificationHow is supplier
currently testing? Compliance history?
DocumentationEstablish record
keeping for frequency of verification activity and
results
Same Example But Change in ControlRaw Peanuts to Supply a Baked Goods Manufacturer
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Same Supplier
Same ImporterChange in Control
New Verification
Same SupplierWe can assume the same supplier of the raw/untreated peanut or other tree nut.
Same Importer We can even assume the same importer ingredient.
Change in ControlBUT if there is a change of control where the ingredient will be used by a customer for further processing, then…
New VerificationImporter now not responsible for hazard analysis and verification BUT must still maintain annual documentation of customer’s compliance
Importer Controls the RiskForeign Supplier Provides Treated Peanuts to Importer
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Importer ControlsThere is no customer to
complete a kill-step. Foreign supplier is completing hazard
control activity.
Hazard AnalysisSalmonella identified as
risk likely to occur.
What Type of Risk?
Likely SAHCODHA
VerificationIf oil roasting used to control hazard, then verify effectiveness. On-site audit may also be required.
1
23 4
Serious HazardOn-Site Audit?
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Import Semi-Soft Cheese
Imported in final form.
Hazard?L. Monocytogenes
Control?Foreign supplier
VerificationOn-Site audit if SAHCODHA, periodic L. Monocytogenes testing, written assurance
RecordsTesting records key part of verification and compliance
Foreign Supplier Compliance History Past Performance Issues in Controlling the Hazard
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LACF ImportPartial exemption that requires verification
Compliance ReviewCompliance review finds
inadequate pH controls and deviations from scheduled
process Hazard?C. botulinum toxin, likely
SAHCODHA. Exempt or now part of verification program?
Control OptionsOn-Site audit if SAHCODHA, periodic pH testing, written
assurance
RecordkeepingDocument corrections to
compliance issues identified as part of verification
program.
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The basics are familiar - hazard analysis and verification - but the level of detail, adaptiveness,
and documentation is robust and new.
The FSVP Tightrope
Review and Strategize The hazard analysis must be robust and avoid the path of least resistance. Important to look at compliance history.
Establish FrequencyHazard control is on-going and must be evaluated for adequacy. Records on how its doing is as important as records of establishment.
Verify, Adapt, Verify… How is the supplier performing? The customer? Adverse events change the analysis?
Automating Supplier and
Quality Management
TraceGains Products
Specification Publishing
Create, maintain, and publish your company’s unique specifications to ensure compliance on incoming ingredients.
Supplier Compliance
Automate lot-by-lot compliance across purchasing, COAs,
receiving, testing, and plant floor.
Finished Goods COAs
Generate finished goods COAs, manage
customer-specific formats, and send to
customers on demand.
Supplier Management
Automatically manage supplier qualification,
documents, and relationships.
Quality Management
Automate HACCP / HARPC and comply with GFSI, FSMA, safety, and quality.
Supplier Analysis& Scorecarding
TraceGains Supplier Management
To-do Lists,Corrective Actions
Access Anywhere,Anytime
Allergens OrganicAudits KosherNutritionSupplier Qualification
FSMA, GFSI, 365 Audit Ready™
C.O.O.L. Specifications
24/7 Monitoring
eNotifications
Labeling(e.g., Genesis)
Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
Gary [email protected]
720-465-9400www.tracegains.com
Marc Sanchez, [email protected]
202.765.4491www.fdaatty.com
