HACCP Regulatory Standards & Compliance 5

Question 1

A small farm selling fresh produce directly to consumers at a roadside stand is subject to which FSMA rule?

Accepted Answer

Produce Safety Rule with qualified exemption possible

Answer

The FSMA Produce Safety Rule applies to farms growing covered produce, though direct-marketing farms may qualify for a qualified exemption based on sales thresholds.

Question 2

Which regulatory requirement must a new USDA-inspected meat establishment complete before beginning commercial production?

Accepted Answer

Conduct a hazard analysis and have a HACCP plan in place before operations begin

Answer

Under 9 CFR Part 417, establishments must complete a hazard analysis and have a written HACCP plan before beginning commercial production.

Question 3

Under the Bioterrorism Act and subsequent FDA regulations, which requirement directly supports HACCP traceability by mandating one-up, one-back recordkeeping?

Accepted Answer

21 CFR Part 1, Subpart J (Establishment and Maintenance of Records)

Answer

21 CFR Part 1, Subpart J requires most FDA-regulated food facilities to maintain records identifying the immediate source and immediate subsequent recipient of food to support traceability.

Question 4

A HACCP plan review conducted as part of a third-party audit finds that the facility has no scientific support for a critical limit of 145°F for whole muscle beef. What is the most appropriate corrective action?

Accepted Answer

Obtain scientific validation supporting the critical limit or adjust it to a validated standard

Answer

Critical limits must be supported by scientific evidence; the facility must either gather validation data supporting 145°F or revise to a limit with established scientific backing.

Question 5

Which statement correctly describes the regulatory relationship between HACCP and Good Manufacturing Practices (GMPs) in US food law?

Accepted Answer

GMPs are prerequisite programs that support HACCP but do not substitute for it

Answer

GMPs (and other prerequisite programs) are foundational controls that support HACCP by maintaining the operating environment, but they are distinct from and do not replace the HACCP system.

HACCP - Hazard Analysis Critical Control Points Practice Test

HACCP - Hazard Analysis Critical Control Points Practice Test

HACCP Regulatory Standards & Compliance 5