- Docket Number:
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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
The purpose of this draft compliance and implementation guidance document is to help covered farms comply with the requirements of the Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” the rule is part of FDA’s implementation of the FDA Food Safety Modernization Act (FSMA).
The draft guidance provides a broad range of recommendations on how to meet the requirements for most subparts of the rule. It also outlines how to determine whether produce or farms may be eligible for exemptions from certain requirements, or from the rule in its entirety.
Specific regulatory or statutory requirements are cited, and in some cases, specified using the word must. The use of the word should indicates that something is recommended, but not required. The use of the word including means options that are not limited to the described items.
You are encouraged to submit comments on the draft guidance within 180 days of the publish date to ensure your comments are considered while FDA works on the final version of the guidance.
In addition to the draft guidance, there is an At-a-Glance overview of key points in each of the nine chapters described below, as well as a glossary of key terms. The overviews summarize important aspects of each chapter. It is recommended that you review the draft guidance itself for complete information.
This chapter will help you determine if your farm and your produce are subject to the requirements in the Produce Safety Rule. The topics in this chapter will help you understand:
- Who is subject to the Produce Safety Rule?
- What is “covered produce”?
- What is a “covered farm”?
- What is a “covered activity”?
- What produce is either not covered or eligible for an exemption?
This chapter will help you evaluate personnel qualifications (such as education, training and experience) and comply with training requirements in the Produce Safety Rule. Topics covered by this chapter include:
- Who is required to have a combination of training, education, or other experience necessary to perform their duties that ensures compliance with the rule?
- How often must personnel receive training?
- What topics are the focus of training?
- Who can provide training?
- How should training be conducted?
- At a Glance: Key Points in Chapter 2 (PDF: 94.6KB); Descripción General: Capitulo 2 (PDF: 92KB)
- Key Terms Glossary (PDF: 130KB)
- Produce Safety Alliance
- Produce International Partnership for Outreach and Education
This chapter provides recommendations on how to use hygienic practices to prevent the contamination of produce and food contact surfaces. Topics covered by this chapter include:
- Health and hygiene considerations for farm personnel, supervisors, and visitors
- The types of health conditions that concern FDA
- The requirements for personnel who report or demonstrate “applicable health conditions”
- Actions to take if you suspect produce or food contact surfaces may have been contaminated
- Recommendations related to hygienic practices
This chapter will help you implement required practices for reducing the risk of produce contamination from certain soil amendments that consist of materials of animal origin, such as manure or non-fecal animal byproducts, which are added to soil to help plant growth or to improve the capacity of the soil to retain water. Topics covered by this chapter include:
- What is a biological soil amendment of animal origin (BSAAO)?
- The difference between “treated” and “untreated” BSAAOs
- Treatment processes
- Application of BSAAOs
- Recommendations for handling, transporting, and storing BSAAOs
- Records requirements and recommendations
This chapter will help you determine whether Subpart I applies to you, and if so, what needs to be done to assess relevant areas on your farm for potential contamination and to evaluate significant evidence of potential contamination. Topics covered in this chapter include:
- How to determine whether, under the circumstances, there is a reasonable probability that domesticated and wild animals will contaminate your covered produce
- How to assess your relevant outdoor areas and partially-enclosed buildings for potential animal contamination
- How to perform monitoring activities
- How to determine if potential contamination is significant
This chapter provides recommendations on practices for safe growing, harvesting packing, and holding activities on your farm. Topics covered in this chapter include:
- What to do if you grow both covered and not covered, or excluded, produce
- Identifying and not harvesting potentially contaminated produce
- Recommendations for the safe handling of harvested produce
- Considerations for the safe packaging of produce
- Recommendations for food-packing materials
This chapter provides recommendations for practices related to equipment, tools, buildings, and sanitation. Topics covered in this chapter include:
- Recommendations for equipment and tools, including design, construction and workmanship; storage; maintenance; cleaning, and when necessary and appropriate sanitizing; and inspection
- Considerations for instruments and controls used to measure, regulate or record conditions to control or prevent the growth of microorganisms
- Recommendations for buildings, including size, construction and design
- How to perform pest control activities
- Recommendations for toilet and hand-washing facilities
- Considerations for sewage systems, including use and maintenance and response to leaks and significant events;
- Recommendations for trash, litter and waste, including collection, storage and disposal
- Considerations for plumbing
- Records recommendations and requirements
This chapter will help you better understand how to create and maintain records required under the Produce Safety Rule. Topics covered by this chapter include:
- How to incorporate information that all records must include
- Recommendations for storing and retaining records
- Options for records format
Draft Guidance Chapter 8: Records (Subpart O) (PDF: 1.7MB)
This chapter will help you better understand how variances can be used and how to prepare a variance request. Topics covered in this chapter include:
- Who can submit a variance petition?
- What a variance petition must include and demonstrate
- Recommended information to include in a variance request
- The process for requesting a variance
Draft Guidance Chapter 9: Variances (Subpart P) (PDF: 1.7MB)
- Download the Full Draft Guidance(PDF: 1.7MB)
- Download all PDF At-a-Glance Overviews of the Produce Safety Rule Draft Guidance chapters (ZIP: 824KB)
- Final Produce Safety Rule
- This page includes links to the rule in the Federal Register. In addition to detailing the requirements, the Federal Register posting provides access to the preamble to the rule, which captures FDA’s response to concerns and questions raised in the public comment period.
- This page also has supporting material that includes fact sheets, related draft guidances and communications from FDA leadership.
- Produce Safety Rule in the Code of Federal Regulations
- You can also read the rule provisions in the CFR, which contains federal rules and regulations.
- Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-3631.