21 CFR Part 112: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Part 112 of title 21 runs to 102 sections across 15 subparts, and sits in subchapter B, Food for Human Consumption. Every section is reproduced in full and is current to 2026-09-10.
- Sections
- 102
- Subparts
- 15
- Words of regulation
- 20,315
- Current to
- 2026-09-10
What this clause controls in practice
A food safety plan controls one hazard under 21 CFR part 112, and FDA food recalls name viral or parasitic contamination in 303 enforcement records since 2012. That is where the clause belongs, not a finding against any firm named below: a recall record states a reason, and most FDA food recalls are initiated by the firm itself.
Recent records naming one of those hazards:
Subpart A: General Provisions
- 112.1 What food is covered by this part?4
- 112.2 What produce is not covered by this part?19
- 112.3 What definitions apply to this part?69
- 112.4 Which farms are subject to the requirements of this part?2
- 112.5 Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?4
- 112.6 What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?9
- 112.7 What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?3
Subpart B: General Requirements
Subpart C: Personnel Qualifications and Training
- 112.21 What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?5
- 112.22 What minimum requirements apply for training personnel who conduct a covered activity?9
- 112.23 What requirements apply regarding supervisors?1
- 112.30 Under this subpart, what requirements apply regarding records?2
Subpart D: Health and Hygiene
- 112.31 What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance?4
- 112.32 What hygienic practices must personnel use?14
- 112.33 What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance?2
Subpart E: Agricultural Water
- 112.40 What requirements of this subpart apply to my covered farm?2
- 112.41 What requirements apply to the quality of my agricultural water?1
- 112.42 What requirements apply to inspecting and maintaining my agricultural water systems?11
- 112.43 What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)?31
- 112.44 What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?19
- 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?11
- 112.46 What requirements apply to treating agricultural water?4
- 112.47 Who must perform the tests required under this subpart?4
- 112.48-112.49 [Reserved]0
- 112.50 Under this subpart, what requirements apply regarding records?14
Subpart F: Biological Soil Amendments of Animal Origin and Human Waste
- 112.51 What requirements apply for determining the status of a biological soil amendment of animal origin?7
- 112.52 How must I handle, convey, and store biological soil amendments of animal origin?3
- 112.53 What prohibitions apply regarding use of human waste?1
- 112.54 What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?5
- 112.55 What microbial standards apply to the treatment processes in § 112.54?3
- 112.56 What application requirements and minimum application intervals apply to biological soil amendments of animal origin?2
- 112.60 Under this subpart, what requirements apply regarding records?6
Subpart I: Domesticated and Wild Animals
- 112.81 How do the requirements of this subpart apply to areas where covered activities take place?4
- 112.83 What requirements apply regarding grazing animals, working animals, and animal intrusion?4
- 112.84 Does this regulation require covered farms to take actions that would constitute a “taking” of threatened or endangered species; to take measures to exclude animals from outdoor growing areas; or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages?1
Subpart K: Growing, Harvesting, Packing, and Holding Activities
- 112.111 What measures must I take if I grow, harvest, pack or hold both covered and excluded produce?3
- 112.112 What measures must I take immediately prior to and during harvest activities?1
- 112.113 How must I handle harvested covered produce during covered activities?1
- 112.114 What requirements apply to dropped covered produce?1
- 112.115 What measures must I take when packaging covered produce?1
- 112.116 What measures must I take when using food-packing (including food packaging) material?4
Subpart L: Equipment, Tools, Buildings, and Sanitation
- 112.121 What equipment and tools are subject to the requirements of this subpart?1
- 112.122 What buildings are subject to the requirements of this subpart?3
- 112.123 What general requirements apply regarding equipment and tools subject to this subpart?9
- 112.124 What requirements apply to instruments and controls used to measure, regulate, or record?4
- 112.125 What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?3
- 112.126 What requirements apply to my buildings?8
- 112.127 What requirements apply regarding domesticated animals in and around a fully-enclosed building?4
- 112.128 What requirements apply regarding pest control in buildings?3
- 112.129 What requirements apply to toilet facilities?7
- 112.130 What requirements apply for hand-washing facilities?8
- 112.131 What must I do to control and dispose of sewage?5
- 112.132 What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?5
- 112.133 What requirements apply to plumbing?5
- 112.134 What must I do to control animal excreta and litter from domesticated animals that are under my control?4
- 112.140 Under this subpart, what requirements apply regarding records?4
Subpart M: Sprouts
- 112.141 What commodities are subject to this subpart?1
- 112.142 What requirements apply to seeds or beans used to grow sprouts?14
- 112.143 What measures must I take for growing, harvesting, packing, and holding sprouts?8
- 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts?8
- 112.145 What requirements apply to testing the environment for Listeria species or L. monocytogenes?9
- 112.146 What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?7
- 112.147 What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?4
- 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?5
- 112.150 Under this subpart, what requirements apply regarding records?8
Subpart N: Analytical Methods
- 112.151 What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?4
- 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)?3
- 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)?5
Subpart O: Records
- 112.161 What general requirements apply to records required under this part?11
- 112.162 Where must I store records?2
- 112.163 May I use existing records to satisfy the requirements of this part?2
- 112.164 How long must I keep records?3
- 112.165 What formats are acceptable for the records I keep?4
- 112.166 What requirements apply for making records available and accessible to FDA?3
- 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA?1
Subpart P: Variances
- 112.171 Who may request a variance from the requirements of this part?3
- 112.172 How may a State, tribe, or foreign country request a variance from one or more requirements of this part?1
- 112.173 What must be included in the Statement of Grounds in a petition requesting a variance?4
- 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?1
- 112.175 Who responds to a petition requesting a variance?1
- 112.176 What process applies to a petition requesting a variance?6
- 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance?3
- 112.178 Under what circumstances may FDA deny a petition requesting a variance?1
- 112.179 When does a variance approved by FDA become effective?1
- 112.180 Under what circumstances may FDA modify or revoke an approved variance?1
- 112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked?15
- 112.182 What are the permissible types of variances that may be granted?4
Subpart Q: Compliance and Enforcement
Subpart R: Withdrawal of Qualified Exemption
- 112.201 Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5?7
- 112.202 What procedure will FDA use to withdraw an exemption?4
- 112.203 What information must FDA include in an order to withdraw a qualified exemption?14
- 112.204 What must I do if I receive an order to withdraw a qualified exemption applicable to my farm?3
- 112.205 Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm?4
- 112.206 What is the procedure for submitting an appeal?4
- 112.207 What is the procedure for requesting an informal hearing?4
- 112.208 What requirements are applicable to an informal hearing?11
- 112.209 Who is the presiding officer for an appeal and for an informal hearing?1
- 112.210 What is the timeframe for issuing a decision on an appeal?4
- 112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked?5
- 112.213 If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?6
Read 21 CFR part 112 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 112 cover?
- 21 CFR part 112 is Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. It runs to 102 sections across 15 subparts and sits in subchapter B of chapter I, Food for Human Consumption.
- Which hazards does 21 CFR part 112 control?
- A food safety plan controls viral or parasitic contamination under part 112. Produce safety: the agricultural water, worker health and hygiene standards for farms growing produce eaten raw.
Every section of part 112 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.