Description
The FDA Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety. As a key element of the preventive approach to better protect public health, FDA published in theFederal Registerthe final rule entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (the produce safety rule, or the rule) (80 FR 74354, November 27, 2015).
Scope & Applicability
Product Classes
6Specific requirements for growing, harvesting, packing and holding; Specific produce category with unique compliance dates and requirements; Specific category often excluded from general pre-harvest water assessments; Specific produce category with unique vulnerability to microbes; Operations with shorter compliance timelines
RACs; Fruits and vegetables subject to section 419 standards; Referred to as RACs in the context of packing and holding.
Fruit or vegetable including mushrooms, sprouts, and herbs
Produce subject to the safety standards in part 112; Produce subject to the requirements of Part 112; Produce subject to the requirements of part 112
Produce in its natural state covered by the rule
Commodities like barley and wheat excluded from the definition of produce
Stakeholders
10The individual required to sign the Food Defense Plan.
Person entering a covered farm with permission
Operation devoted to harvesting, packing, and holding
Operation under one management devoted to growing crops; Farm that grows, harvests, and/or raises commodities
Entities with specific compliance timelines
Entity providing treated compost to growers
Official authorized to sign withdrawal orders
Target audience for the compliance guide
Farms subject to the requirements of part 112
Consumer, restaurant, or retail food establishment meeting specific distance or location criteria
Regulatory Context
Attributes
5No detectable generic E. coli in 100 mL
Water open to the atmosphere
Fresh water found beneath the Earth's surface
Standard record retention period
Application interval for raw manure on crops in contact with soil
Identified Hazards
Hazards
6Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Biological hazard associated with the farm or food
Source of potential contamination in growing areas
Toxin hazard in certain produce like mushrooms
biological hazard in frozen ice cream novelty; Biological hazard in cheese
Basis for withdrawing a qualified exemption; Public health event that may trigger withdrawal of exemption
Related CFR Sections (20)
- 21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
- 21CFR112.161§ 112.161 What general requirements apply to records required under this part?
(a) Except as otherwise specified, all records required under this part must:Read full regulation →
- 21CFR112.151§ 112.151 What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part ?
You must test the quality of water using:Read full regulation →
- 21CFR112.145§ 112.145 What requirements apply to testing the environment for Listeria species or L. monocytogenes?
All of the following testing requirements apply for the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes.Read full regulation →
- 21CFR112.153§ 112.153 What methods must I use to test spent sprout irrigation water (or sprouts) from each production batch of sprouts for pathogens to satisfy the requirements of § 112.144(b) and (c) ?
You must test spent sprout irrigation water (or sprouts) from each production batch for pathogens using:Read full regulation →
- 21CFR112.152§ 112.152 What methods must I use to test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes to satisfy the requirements of § 112.144(a) ?
You must test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes using:Read full regulation →
- 21CFR112.144§ 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts?
All of the following testing must be done during growing, harvesting, packing, and holding sprouts:Read full regulation →
- 21CFR112.114§ 112.114 What requirements apply to dropped covered produce?
You must not distribute dropped covered produce. Dropped covered produce is covered produce that drops to the ground before harvest. Dropped covered produce does not include root crops that grow underground (such as carrots), crops that grow on the ground (such as cantaloupe), or produce that is intRead full regulation →
- 21CFR112.112§ 112.112 What measures must I take immediately prior to and during harvest activities?
You must take all measures reasonably necessary to identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard, including steps to identify and not harvest covered produce that is visibly contaminated with animal excreta. At aRead full regulation →
- 21CFR112.83§ 112.83 What requirements apply regarding grazing animals, working animals, and animal intrusion?
(a) You must take the steps set forth in paragraph (b) of this section if under the circumstances there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce.Read full regulation →
- 21CFR112.53§ 112.53 What prohibitions apply regarding use of human waste?
You may not use human waste for growing covered produce, except sewage sludge biosolids used in accordance with the requirements of 40 CFR part 503, subpart D , or equivalent regulatory requirements.Read full regulation →
- 21CFR112.55§ 112.55 What microbial standards apply to the treatment processes in § 112.54 ?
The following microbial standards apply to the treatment processes in § 112.54 as set forth in that section.Read full regulation →
- 21CFR112.56§ 112.56 What application requirements and minimum application intervals apply to biological soil amendments of animal origin?
(a) You must apply the biological soil amendments of animal origin specified in the first column of the table in this paragraph (a) in accordance with the application requirements specified in the second column of the table in this paragraph (a) and the minimum application intervals specified in theRead full regulation →
- 21CFR112.51§ 112.51 What requirements apply for determining the status of a biological soil amendment of animal origin?
(a) A biological soil amendment of animal origin is treated if it has been processed to completion to adequately reduce microorganisms of public health significance in accordance with the requirements of § 112.54 , or, in the case of an agricultural tea, the biological materials of animal origin useRead full regulation →
- 21CFR112.54§ 112.54 What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?
Each of the following treatment processes are acceptable for a biological soil amendment of animal origin that you apply in the growing of covered produce, provided that the resulting biological soil amendments are applied in accordance with the applicable requirements of § 112.56 :Read full regulation →
- 21CFR112.46§ 112.46 What requirements apply to treating agricultural water?
(a) Any method you use to treat agricultural water (such as with physical treatment, including using a pesticide device as defined by the U.S. Environmental Protection Agency (EPA); EPA-registered antimicrobial pesticide product; or other suitable method) must be effective to make the water safe andRead full regulation →
- 21CFR112.45§ 112.45 What measures must I take for agricultural water to reduce the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards?
(a) Discontinue use(s). If you have determined or have reason to believe that your agricultural water is not safe or of adequate sanitary quality for its intended use(s) in growing, harvesting, packing, or holding covered produce as required under § 112.41 , and/or if your agricultural water used asRead full regulation →
- 21CFR112.44§ 112.44 What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?
(a) Microbial quality criterion. When you use agricultural water for any one or more of the following purposes, you must ensure there is no detectable generic Escherichia coli ( E. coli ) in 100 milliliters (mL) of agricultural water, and you must not use untreated surface water for any of these purRead full regulation →
- 21CFR112.43§ 112.43 What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)?
(a) Elements of an agricultural water assessment. Based in part on the results of any inspections and maintenance you conducted under § 112.42 , at the beginning of the growing season, as appropriate, but at least once annually, you must prepare a written agricultural water assessment for water thatRead full regulation →
- 21CFR112.42§ 112.42 What requirements apply to inspecting and maintaining my agricultural water systems?
(a) Inspection of your agricultural water systems. At the beginning of a growing season, as appropriate, but at least once annually, you must inspect all of your agricultural water systems, to the extent they are under your control, to identify any conditions that are reasonably likely to introduce Read full regulation →
Related Warning Letters (10)
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-07-15
Foreign Supplier Verification Program (FSVP)
A.D. Berries @ More LLC
- 2025-06-10
Foreign Supplier Verification Program (FSVP)
Gongora USA Corp
- 2025-06-03
Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated
Jack & The Green Sprouts, Inc.
- 2025-06-03
Foreign Supplier Verification Program (FSVP)
Amore Produce, LLC
- 2025-06-03
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Everything Sprouts, LLC
- 2025-05-27
Foreign Supplier Verification Program (FSVP)
San Juan Produce LLC
- 2025-05-27
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Wailea Agricultural Group, Inc.
- 2025-03-25
Foreign Supplier Verification Program (FSVP)
Gonzar Produce, LLC
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- CVM GFI #239 Human Food By-Products For Use As Animal Food (Status: Draft)
- Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (Status: Draft)
- CVM GFI #241 Small Entity Compliance Guide – What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507) (Status: Final)
- Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (Status: Final)
- Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 (Status: Draft)
- Small Entity Compliance Guide: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules of the FDA Food Safety Modernization Act (Status: Final)