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ALLERGEN'CONTROL'UNDER'THE'US'FOOD'SAFETY'MODERNIZATION'ACT'(FSMA)
STEVEN GENDELVP, FOOD ALLERGENS DIVISIONIEH LABORATORIES AND CONSULTING GROUP
Laboratories*&*Consulting*Group 1
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Laboratories*&*Consulting*Group
FSMA 1 LAW7 MAJOR RULES
Rule Status
Preventive'ControlsHuman'Food
Final
Foreign'Supplier'Verification Final
Sanitary'Transportation Final
Intentional'Adulteration Proposed
Preventive ControlsAnimal'Feed
Final
Produce'Safety Final
Third'Party Certification Final
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Laboratories*&*Consulting*Group
BASIC PHILOSOPHY
• Three'simple'steps• Implement'GMPs• Do'a'hazard'analysis• Implement'needed'preventive'controls'
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Laboratories*&*Consulting*Group
PREVENTIVE CONTROLS FOR HUMAN FOODS RULE
• Two'major'parts
• Modernized'GMPs• Hazard'Analysis'and'Preventive'Controls
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Laboratories*&*Consulting*Group
“MODERNIZED” GMPS
• New'wording:• “protect'against'allergen'crossTcontact'and'contamination”''
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Laboratories*&*Consulting*Group
PREVENTIVE CONTROLS• Implemented'through'a'Food'Safety'Plan• FSP'must'be'based'on'a'Hazard'Analysis'• Hazard'Analysis'identifies
1. “Known'or'reasonably'foreseeable”'hazards
2. “Hazards'requiring'a'preventive'control”
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Laboratories*&*Consulting*Group
FOOD SAFETY PLAN COMPONENTS• Hazard'analysis• Preventive'controls• SupplyTchain'program• Procedures'for'monitoring• Corrective'action'procedures• Verification'procedures• Recall'plan
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Laboratories*&*Consulting*Group
WHAT ARE PREVENTIVE CONTROLS?• Process'controls• Food'allergen'controls• Sanitation'controls• SupplyTchain'controls• Recall'plan
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Laboratories*&*Consulting*Group
HOW DOES THIS RELATE TO HACCP AS WE KNOW IT?
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Laboratories*&*Consulting*Group
ONE FLAVOR OF HACCP
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PrereqsCCP
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Laboratories*&*Consulting*Group
ANOTHER FLAVOR OF HACCP
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PRP
OPRP
CCP
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Laboratories*&*Consulting*Group
PREVENTIVE CONTROLS
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GMP
PrevCont
ProcessControls
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Laboratories*&*Consulting*Group
PREVENTIVE CONTROLS
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AllergenControls
SanitationControls
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Laboratories*&*Consulting*Group
PREVENTIVE CONTROLS
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FDA'says'that'it'doesn’t'matter'what'you'call'the'control'– as'long'as'it'works'and'you'control'all'of'your'hazards
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Laboratories*&*Consulting*Group
ALLERGEN CONTROLS(2)'Food$allergen$controls.$Food'allergen'controls'include'procedures,'practices,'and'processes'to'control'food'allergens.'Food'allergen'controls'must'include'those'procedures,'practices,'and'processes'employed'for:'
(i)'Ensuring'protection of'food'from allergen'crossTcontact,'including'during'storage,'handling,'and'used'and(ii)'Labeling'the'finished'food,'including'ensuringthat'the'finished'food'is'not'misbranded
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Laboratories*&*Consulting*Group
ALLERGEN CONTROLS
• Allergen'Hazard'Analysis
• Considers'intended'allergens• Ingredients'and'subTingredients
• Considers'unintended'allergens• CrossTcontact• EMA
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Laboratories*&*Consulting*Group
ALLERGEN CONTROLS
• Supply'Chain'Applied'Control
• When'a'supplier'controls'a'hazard
• Control'need'to'be'documented• GMPs'and'Transport'Rule'require'prevention'of'crossTcontact'during'transport
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Laboratories*&*Consulting*Group
ALLERGEN CONTROLS
• In'a'facility
• Segregate• Separate• Sequence• Sanitation
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Laboratories*&*Consulting*Group
ALLERGEN CONTROLS
• Labeling
• The'label'needs'to'be'correct• The'label'needs'to'be'on'the'right'product• Matching'the'label'and'the'product'can'be'a'Preventive'Control
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Laboratories*&*Consulting*Group
ALLERGEN CONTROLS
• Supply'chain'controls'(again)
• You'might'be'a'supplier'controlling'a'hazard'for'someone'else
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Laboratories*&*Consulting*Group
DOCUMENTS AND RECORDS • Food'Safety'Plan• Including'documentation'of'all'decisions
• Implementation'Records• Monitoring• Verification• Validation• Corrective'Actions
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Laboratories*&*Consulting*Group
DOCUMENTS AND RECORDS • Record'reviews• Specific'time'frames
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Laboratories*&*Consulting*Group
THE TAKE HOME MESSAGES• The'world'of'food'safety'regulation'in'the'US'is'evolving'rapidly'
• Multiple'new'interlocking'regulations'are'coming'into'effect
• These'rules'will'have'an'international'impact
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Laboratories*&*Consulting*Group
THE TAKE HOME MESSAGES• MANUFACTURERS'ARE'RESPONSIBLE'FOR'DEVELOPING'AND'JUSTIFYING'THE'FOOD'SAFETY'SYSTEMS'THEY'USE
• Scientific'data'are'critical• Documentation'is'essential
• Continuously• Allergen'control'needs'to'be'an'integral'part'of'all'food'safety'systems'
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Laboratories*&*Consulting*Group
THANKS FOR YOUR TIME
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www.iehinc.com
EHISteven Gendel
Vice President,
Division of Food Allergens
15300 Bothell Way NE
Lake Forest Park, WA 98155
p 206.940.5308 | f [email protected]