FSMA

Question 1

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

Answer 1

79%

Question 2

—— of all foods consumed in the US is imported

Answer 2

15%

Question 3

How many percent of imported food is sea food

Answer 3

75%

Question 4

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

Answer 4

1%

Question 5

What is historic and important about FSMA ?

Answer 5

• 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

Question 6

Main themes of FSMA

Answer 6

Prevention
Enhanced partnership
Inspection, compliance and Response
Import safety

Question 7

Is prevention new ?

Answer 7

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

Question 8

General approach to preventive controls ?

Answer 8

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

Question 9

Examples of Compliance with Prevention Standards

Answer 9

Sanitation
• Training for supervisors and employees
• Environmental controls and monitoring • Food allergen controls
• Recall contingency plan
• Good Manufacturing Practices (GMPs)
• Supplier verification activities

Question 10

GMP is part of —–part of FSMA

Answer 10

Prevention

Question 11

What is the most groundbreaking shift ?

Answer 11

Import safety

Question 12

How was the law for importing before FSMA ?

Answer 12

Just inspection on port of entry

Question 13

Law for importing after FSMA

Answer 13

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

Question 14

Foreign supplier verification program

Answer 14

Requires importers to verify their suppliers use risk-based preventive controls that provide same level of protection as U.S. requirements.

Question 15

Foreign supplier verification program

Answer 15

Requires importers to verify their suppliers use risk-based preventive controls that provide same level of protection as U.S. requirements.

Question 16

Voluntary qualified importer program

Answer 16

Allows for expedited review and entry; facility certification required

Question 17

Certification for high-risk food imports

Answer 17

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

Question 18

Prior notice of imported food shipments

Answer 18

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

Question 19

Capacity building

Answer 19

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

Question 20

Capacity building

Answer 20

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

Question 21

Inspection of foreign food facilities

Answer 21

Can deny entry if FDA access for inspection is denied

Question 22

Accreditation of third-party auditors

Answer 22

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

Question 23

Foreign supplier verification program

FSVP requirement vary based on

Answer 23

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

Question 24

What is Exempt from FSVP

Answer 24

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)

Question 25

FSVP requirements

Answer 25

– 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

Question 26

What part of FSMA is vital to success

Answer 26

Enhanced partnership

Question 27

Capacity building helps to

Answer 27

Prevent problems before products reach the US port of entry