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          Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionSearch for FDA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	Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption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


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2019-D-2131
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


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.

Download the Guidance

Related Information

Additional Produce Guidance
	FSMA Guidance
	Food Guidance
	FSMA Produce Safety Rule
	FSMA Training
	What's New in FSMA
	FDA Publishes Guidance Document on How to Choose Alternate Curricula for Produce Safety TrainingSubmit Comments
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						All written comments should be identified with this document's docket number: FDA-2019-D-2131.

                                                                                  Content current as of:
      06/03/2019
         
                  
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