FSMA Flashcards
FDA is responsible for about —- of the US food supply
79%
—— of all foods consumed in the US is imported
15%
How many percent of imported food is sea food
75%
FDA is only responsible for about …… of all imported foods in the US
1%
What is historic and important about FSMA ?
- Involves creation of a new food safety system
- Broad prevention mandate and accountability
- New system of import oversight
- Emphasizes partnerships
- Emphasizes farm-to-table responsibility
- Developed through broad coalition
Main themes of FSMA
Prevention
Enhanced partnership
Inspection, compliance and Response
Import safety
Is prevention new ?
No but the congress has given FDA explicit authority to use tool more broadly
General approach to preventive controls ?
- Identify Hazard
- Understand cause
- Implement preventive controls
- Monitor effectiveness
- Review & adjust
Examples of Compliance with Prevention Standards
Sanitation
• Training for supervisors and employees
• Environmental controls and monitoring • Food allergen controls
• Recall contingency plan
• Good Manufacturing Practices (GMPs)
• Supplier verification activities
GMP is part of —–part of FSMA
Prevention
What is the most groundbreaking shift ?
Import safety
How was the law for importing before FSMA ?
Just inspection on port of entry
Law for importing after FSMA
Importers are now responsible for ensuring that their foreign suppliers have adequate preventive controls in place
Require food from abroad to be as safe as domestic
Foreign supplier verification program
Requires importers to verify their suppliers use risk-based preventive controls that provide same level of protection as U.S. requirements.
Foreign supplier verification program
Requires importers to verify their suppliers use risk-based preventive controls that provide same level of protection as U.S. requirements.
Voluntary qualified importer program
Allows for expedited review and entry; facility certification required
Certification for high-risk food imports
FDA has discretionary authority to require assurances of compliance for high-risk foods
Prior notice of imported food shipments
Requires information on prior refusals to be added to prior notice submission
Capacity building
FDA mandate to work with foreign governments to build food safety capacity
Capacity building
FDA mandate to work with foreign governments to build food safety capacity
Inspection of foreign food facilities
Can deny entry if FDA access for inspection is denied
Accreditation of third-party auditors
FDA can rely on accredited third parties to certify that foreign
food facilities meet U.S. requirements
Foreign supplier verification program
FSVP requirement vary based on
Type of food product
Category of importer, such as very small
Nature of the hazard identified in the food Who is to control the hazard
What is Exempt from FSVP
Importation of juice and seafood whose suppliers are in compliance with HACCP regulations
Food imported for research and evaluation purposes
Food imported for personal consumption • Alcoholic beverages
Food that is transshipped or that is imported for future export and not consumed or distributed in the U.S.
Products from facilities subject to FDA’s low acid canned food requirements (exempt for
microbiological hazards only)
FSVP requirements
– Compliance status review of foods and suppliers – Hazard analysis – Supplier verification activities – Corrective actions (if necessary) – Periodic reassessment of the FSVP – Importer identification at entry -Recordkeeping
What part of FSMA is vital to success
Enhanced partnership
Capacity building helps to
Prevent problems before products reach the US port of entry
