Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Description

In theFederal Registerof November 27, 2015, FDA published a final rule titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (80 FR 74353) (Produce Safety Rule).  The Produce Safety Rule established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. The rule requires covered farms to take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to provide reasonable assurances that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act. (21 CFR 112.11). Requirements of the rule focus on different topics, including major routes of contamination; personnel qualifications and training; growing, harvesting, packing, and holding activities; and sprouts. Subpart C includes the specific requirements for personnel qualifications and training, including the requirement for at least one supervisor or responsible party for your farm to successfully complete food safety training at least equivalent to that received under the standardized curriculum recognized as adequate by FDA. (see 21 CFR 112.22(c)).

Scope & Applicability

Regulatory Context

• 21CFR10.115§ 10.115 Good guidance practices.

  (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

• 21CFR112.11§ 112.11 What general requirements apply to persons who are subject to this part?

  You must take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to Read full regulation →

• 21CFR112.22§ 112.22 What minimum requirements apply for training personnel who conduct a covered activity?

  (a) At a minimum, all personnel who handle (contact) covered produce during covered activities or supervise the conduct of such activities must receive training that includes all of the following:Read full regulation →

• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

  Wailea Agricultural Group, Inc.

  2025-05-27

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