Overview of FDA's Food Defense Activities - Food and Drug Law ...
Overview of FDA's Food Defense Activities - Food and Drug Law ...
Overview of FDA's Food Defense Activities - Food and Drug Law ...
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<strong>Food</strong> Safety Modernization ActIntentional Adulteration Provisions• Section 103 - Hazard Analysis <strong>and</strong> Risk-Based Preventive Controls– “...hazards that occur naturally or may be intentionallyintroduced.”– “…identify <strong>and</strong> evaluate hazards that may beintentionally introduced, including by acts <strong>of</strong>terrorism…”• Section 105 – St<strong>and</strong>ards for Produce Safety– “…consider hazards …. that may be intentionallyintroduced, including by acts <strong>of</strong> terrorism…”<strong>Food</strong> Safety Modernization ActIntentional Adulteration Provisions• Section 106 – Protection Against IntentionalAdulteration– Determinations – vulnerability assessment, economic assessment,science-based mitigation strategies– Regulations• Assess individual implementation requirements for mitigation strategies• Specify appropriate science-based mitigation strategies– Regulation Applicability – foods with a high risk <strong>of</strong> intentionalcontamination (exception – farms, but does apply to milk)– Guidance Documents – model assessment, example <strong>of</strong> mitigationstrategies, examples <strong>of</strong> situations where mitigation strategies areappropriate3
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