The US Legal System

Question 1

Law

Answer 1

Implies imposition by a sovereign authority (congress)

Question 2

Statue

Answer 2

A law enacted by a legislative body

Question 3

Regulation

Answer 3

Prescription by an administrative agency to carry out their statutory responsibilities

Question 4

Agencies make

Answer 4

the regulations based on the law

Question 5

Rule

Answer 5

Applies more restricted or more specific laws than statutes

Question 6

Guideline

Answer 6

Suggest something advisory rather than binding

Question 7

Ordianance

Answer 7

Applies to an order enforced by a local unit government (like a city)

Question 8

Prevention: The Cornerstone

Answer 8

• Comprehensive preventive controls
• Produce safety standards (Produce Safety Rule)
• International Adulteration Standards
• Transportation

Question 9

Importance to Public Health

Answer 9

• Foodborne illness is a significant burden
• Immune-compromised individuals more susceptible
• Foodborne illness is not just a stomach ache

Question 10

Need for the FSMA

Answer 10

Food supply more high-tech complex

Shifting demographics

Question 11

What’s so historic about FSMA

Answer 11

• 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

Question 12

Enhanced Partnerships: Vital to Success

Answer 12

• Reliance on inspection by other agencies
• State/local and international capacity building
• Improve foodborne illness surveillance (CDC)
• National agriculture and food defense strategy
• Consortium of laboratory networks
• Easier to find recall information

Question 13

Examples of Compliance with Prevention Standards

Answer 13

• Sanitation (removal of microorganism)
• Training for supervisors and employees
• Environmental controls and monitoring
• Food allergen controls
• Recall Contingency Plan
• GMPs and Supplier Verification Activities

Question 14

Prevention Standards Mandates (developed under FSMA)
Sec. 105 Standard for Produce Safety

Answer 14

• Established science-based minimum standards for the safe production and harvesting of fruits and vegetables
• Applies to raw agricultural commodities (RAC) for which FDA determines that such standards minimize the risk of serious adverse health consequences or death

Question 15

General Approach to Preventive Controls

Answer 15

1) Identify Hazard
2) Understand Cause
3) Implement Preventive Controls
4) Monitor Effectiveness
5) Review & Adjust

Question 16

Prevention Standards Mandates: Sec. 103. Hazard analysis and risk-based preventive controls - Requires humans and animals food facilities to

Answer 16

• Evaluate hazards that could effect food safety
• Identify and implement preventive controls to prevent hazards
• Monitor controls and maintain monitoring records
• Conduct verification activities

Question 17

Intentional Contamination: Sec. 106. Protection against International Adulteration

Answer 17

• Issue final rule and guidance
• Conduct vulnerability assessments

Question 18

Intentional Contamination: Sec. 111. Sanitary Transportation of Food

Answer 18

• Addresses implementation of the Sanitary Food Transportation Act of 2005, which requires persons engaged in food transportation to use sanitary transportation practices to ensure that food is not transported under conditions that may render it adulterated