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GUIDANCE DOCUMENT

Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption June 2019

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-2131
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

June 2019

In the Federal Register of 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)).

For farms covered by the Produce Safety Rule, version 1.1 of the standardized curriculum developed by the Produce Safety Alliance (PSA) is adequate as the standardized curriculum in 21 CFR 112.22(c) (see Subpart C – Personnel Qualifications and Training of the Produce Safety Rule). The purpose of this guidance is to provide recommendations on the factors that covered farms should consider if they are selecting an alternate curriculum training to meet the requirements of 21 CFR 112.22(c), and that educators should consider when developing or evaluating alternate curricula. This guidance focuses on the standardized curriculum developed by the PSA.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2019-D-2131.