Regulatory Framework & Compliance Flashcards

A GAP-certified grower must retain food safety records for a minimum of how many years under the FSMA Produce Safety Rule?

Answer: 2 years

The FSMA Produce Safety Rule requires covered farms to maintain records for at least 2 years.

Which USDA program administers voluntary GAP and GHP audits for domestic produce operations?

Answer: Agricultural Marketing Service (AMS)

USDA's Agricultural Marketing Service (AMS) administers the voluntary GAP and GHP audit program.

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?

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.

Under GlobalG.A.P. certification, a Major Must requirement that is not met results in:

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.

The concept of 'responsible party' under FSMA refers to:

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.

Which section of the Code of Federal Regulations (CFR) contains the FSMA Produce Safety Rule?

Answer: 21 CFR Part 112

The FSMA Produce Safety Rule is codified at 21 CFR Part 112.

A qualified exemption from the Produce Safety Rule requires a farm to notify consumers of its name and address. This notification must appear:

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.