Food Safety at FDA July 12 2018 What is Food Federal Food Drug and Cosmetic Act FFDCA Sec 201f defines the term Food to mean Articles used for food or drink for man or other animals ID: 689253
Download Presentation The PPT/PDF document "Regulatory Framework for" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Regulatory Framework for Food Safety at FDA
July 12, 2018Slide2
What is Food?
Federal Food, Drug, and Cosmetic Act (FFDCA) Sec. 201(f) defines the term “Food” to mean
Articles used for food or drink for man or other animals
Chewing gum Articles used for components of any such article
www.fda.govSlide3
Food must be safe and not adulterated
FFDCA Sec. 402 (a) considers a food is adulterated
(1) if its bears or contains any poisonous or deleterious substance which may render it injurious to health. But in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health
www.fda.govSlide4
Food must be safe and not adulterated
FFDCA Sec. 402 considers a food is adulterated
(2)(C) if it bears or contains (i) any food additive that is unsafe within the meaning of section 409
(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health
www.fda.govSlide5
FDA Food Safety Modernization Act
Focus on prevention and risk-based safety standards
New enforcement authorities
Important new tools to hold imported foods to the same standards as domestic foodswww.fda.govSlide6
Hazard Analysis and Risk-Based Controls
A key component of FSMA amends FFDCA with Sec. 418 “Hazard Analysis and Risk-Based Preventive Controls”
Implementing regulation - 21 CFR part 117 “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.”
Updates cGMPRequires food safety plan for facilities that manufacture, process, pack or hold human food (unless an exemption applies)
www.fda.govSlide7
Required Food Safety Plan
Hazard analysis
Known or reasonably foreseeable
Biological, chemical, physical hazardsPreventive controlsProcess, allergen, sanitation, other as neededOversight and management of controlsMonitoring, correction, corrective action, verificationSupply chain program
If needed based on hazard analysis
Recall planSlide8
Regulatory Tools
Prevention
Mandatory food safety plans with risk-based controls
Inspection and complianceMandated inspection frequency based on risk for domestic and foreign facilitiesRecords access, including to food safety plans and records of implementationEnforcementMandatory recalls
Suspension of facility registration
Importer accountability
Authority to deny entry to imported foodsSlide9
When Evaluating A New Production Process for a Food
Hazards identified by the food safety plan?
Appropriate and adequate controls?
Are all ingredient uses safe and lawful?Slide10