Comprehensive FSMA and Food Safety
Regulations for Food Industry Questions with
Verified Correct Answers
Food Safety Plan
The FSMA-required document addressing general food safety hazards (biological, chemical,
physical) in a facility's process.
Food Defense Plan
The FSMA-required document addressing intentional adulteration risks (e.g. sabotage,
tampering) — different from a Food Safety Plan.
HACCP
Hazard Analysis and Critical Control Points — a specific methodology for identifying and
controlling hazards at critical points in production; not the same as a full FSMA Food Safety Plan.
FSMA
Food Safety Modernization Act — shifted FDA's approach from responding to contamination to
preventing it; source of the Food Safety Plan and Food Defense Plan requirements.
21 CFR Part 117
Federal regulation covering Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food.
21 CFR Part 133
Federal regulation defining cheese and cheese products — the legal "standards of identity" for
what can be labeled cheddar, cheese, etc.
21 CFR Part 1, Subpart S
The FSMA Traceability Rule — requires enhanced recordkeeping for certain high-risk foods as
they move through the supply chain.
Qualified Facility / Very Small Business exemption
Regulations for Food Industry Questions with
Verified Correct Answers
Food Safety Plan
The FSMA-required document addressing general food safety hazards (biological, chemical,
physical) in a facility's process.
Food Defense Plan
The FSMA-required document addressing intentional adulteration risks (e.g. sabotage,
tampering) — different from a Food Safety Plan.
HACCP
Hazard Analysis and Critical Control Points — a specific methodology for identifying and
controlling hazards at critical points in production; not the same as a full FSMA Food Safety Plan.
FSMA
Food Safety Modernization Act — shifted FDA's approach from responding to contamination to
preventing it; source of the Food Safety Plan and Food Defense Plan requirements.
21 CFR Part 117
Federal regulation covering Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food.
21 CFR Part 133
Federal regulation defining cheese and cheese products — the legal "standards of identity" for
what can be labeled cheddar, cheese, etc.
21 CFR Part 1, Subpart S
The FSMA Traceability Rule — requires enhanced recordkeeping for certain high-risk foods as
they move through the supply chain.
Qualified Facility / Very Small Business exemption
