GAP Regulatory Framework & Compliance 3 — Questions and Answers
Question 1: A GAP-certified grower must retain food safety records for a minimum of how many years under the FSMA Produce Safety Rule?
- 1 year
- 2 years (Correct answer)
- 3 years
- 5 years
Correct answer: 2 years
The FSMA Produce Safety Rule requires covered farms to maintain records for at least 2 years.
Question 2: Which USDA program administers voluntary GAP and GHP audits for domestic produce operations?
- Food Safety and Inspection Service (FSIS)
- Agricultural Marketing Service (AMS) (Correct answer)
- Animal and Plant Health Inspection Service (APHIS)
- National Institute of Food and Agriculture (NIFA)
Correct answer: Agricultural Marketing Service (AMS)
USDA's Agricultural Marketing Service (AMS) administers the voluntary GAP and GHP audit program.
Question 3: When a farm is inspected under the FSMA Produce Safety Rule and a serious violation is found, what is the inspector's most immediate required action?
- Issue a warning letter
- Initiate a mandatory recall
- Document the observation on FDA Form 483 (Correct answer)
- Immediately shut down the operation
Correct answer: Document the observation on FDA Form 483
Inspectors document observations of violations on FDA Form 483, which is issued to the facility at the close of the inspection.
Question 4: Under GlobalG.A.P. certification, a Major Must requirement that is not met results in:
- A minor nonconformance note
- Immediate certificate suspension or denial (Correct answer)
- A 3-month corrective action period
- A 10% score deduction only
Correct answer: Immediate certificate suspension or denial
Failure to comply with any Major Must (major must-do) requirement results in immediate suspension or denial of GlobalG.A.P. certification.
Question 5: The concept of 'responsible party' under FSMA refers to:
- The lead auditor conducting a GAP inspection
- The owner, operator, or agent in charge of a covered farm or facility (Correct answer)
- The FDA district director overseeing compliance
- The third-party certification body
Correct answer: The owner, operator, or agent in charge of a covered farm or facility
The 'responsible party' is the owner, operator, or agent in charge who is accountable for compliance with FSMA requirements.
Question 6: Which section of the Code of Federal Regulations (CFR) contains the FSMA Produce Safety Rule?
- 21 CFR Part 11
- 21 CFR Part 112 (Correct answer)
- 40 CFR Part 180
- 7 CFR Part 205
Correct answer: 21 CFR Part 112
The FSMA Produce Safety Rule is codified at 21 CFR Part 112.
Question 7: A qualified exemption from the Produce Safety Rule requires a farm to notify consumers of its name and address. This notification must appear:
- On a sign posted at the point of sale or on the label of the produce (Correct answer)
- In an annual report submitted to the FDA
- On the farm's website only
- In a letter sent to local health departments
Correct answer: On a sign posted at the point of sale or on the label of the produce
Qualified exempt farms must disclose their name and address at point of sale or on a label so consumers can trace the source.
GAP Regulatory Framework & Compliance 3
A GAP-certified grower must retain food safety records for a minimum of how many years under the FSMA Produce Safety Rule?