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Flashcards in FSMA Deck (27):
1

FDA is responsible for about ---- of the US food supply

79%

2

------ of all foods consumed in the US is imported

15%

3

How many percent of imported food is sea food

75%

4

FDA is only responsible for about ...... of all imported foods in the US

1%

5

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

6

Main themes of FSMA

Prevention
Enhanced partnership
Inspection, compliance and Response
Import safety

7

Is prevention new ?

No but the congress has given FDA explicit authority to use tool more broadly

8

General approach to preventive controls ?

1. Identify Hazard
2. Understand cause
3. Implement preventive controls
4. Monitor effectiveness
5. Review & adjust

9

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

10

GMP is part of -----part of FSMA

Prevention

11

What is the most groundbreaking shift ?

Import safety

12

How was the law for importing before FSMA ?

Just inspection on port of entry

13

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

14

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.

15

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.

16

Voluntary qualified importer program

Allows for expedited review and entry; facility certification required

17

Certification for high-risk food imports

FDA has discretionary authority to require assurances of compliance for high-risk foods

18

Prior notice of imported food shipments

Requires information on prior refusals to be added to prior notice submission

19

Capacity building

FDA mandate to work with foreign governments to build food safety capacity

20

Capacity building

FDA mandate to work with foreign governments to build food safety capacity

21

Inspection of foreign food facilities

Can deny entry if FDA access for inspection is denied

22

Accreditation of third-party auditors

FDA can rely on accredited third parties to certify that foreign
food facilities meet U.S. requirements

23

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

24

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)

25

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

26

What part of FSMA is vital to success

Enhanced partnership

27

Capacity building helps to

Prevent problems before products reach the US port of entry