21 CFR PART 112
21 CFR Part 112
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
FDA's Produce Safety Rule under FSMA. Standards for growing, harvesting, packing, and holding of covered produce. Worker hygiene, agricultural water, soil amendments, animals in fields, equipment, sanitation, and records.
- Subpart AGeneral Provisions
- § 112.1What food is covered by this part?
- § 112.2What produce is not covered by this part?
- § 112.3What definitions apply to this part?
- § 112.4Which farms are subject to the requirements of this part?
- § 112.5Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?
- § 112.6What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?
- § 112.7What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?
- Subpart BGeneral Requirements
- Subpart CPersonnel Qualifications and Training
- § 112.21What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?
- § 112.22What minimum requirements apply for training personnel who conduct a covered activity?
- § 112.23What requirements apply regarding supervisors?
- § 112.30Under this subpart, what requirements apply regarding records?
- Subpart DHealth and Hygiene
- § 112.31What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance?
- § 112.32What hygienic practices must personnel use?
- § 112.33What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance?
- Subpart EAgricultural Water
- § 112.40What requirements of this subpart apply to my covered farm?
- § 112.41What requirements apply to the quality of my agricultural water?
- § 112.42What requirements apply to inspecting and maintaining my agricultural water systems?
- § 112.43What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)?
- § 112.44What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?
- § 112.45What 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?
- § 112.46What requirements apply to treating agricultural water?
- § 112.47Who must perform the tests required under this subpart?
- § 112.48-112.49§§ 112.48-112.49 [Reserved]
- § 112.50Under this subpart, what requirements apply regarding records?
- Subpart FBiological Soil Amendments of Animal Origin and Human Waste
- § 112.51What requirements apply for determining the status of a biological soil amendment of animal origin?
- § 112.52How must I handle, convey, and store biological soil amendments of animal origin?
- § 112.53What prohibitions apply regarding use of human waste?
- § 112.54What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?
- § 112.55What microbial standards apply to the treatment processes in § 112.54?
- § 112.56What application requirements and minimum application intervals apply to biological soil amendments of animal origin?
- § 112.60Under this subpart, what requirements apply regarding records?
- Subpart IDomesticated and Wild Animals
- § 112.81How do the requirements of this subpart apply to areas where covered activities take place?
- § 112.83What requirements apply regarding grazing animals, working animals, and animal intrusion?
- § 112.84Does 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?
- Subpart KGrowing, Harvesting, Packing, and Holding Activities
- § 112.111What measures must I take if I grow, harvest, pack or hold both covered and excluded produce?
- § 112.112What measures must I take immediately prior to and during harvest activities?
- § 112.113How must I handle harvested covered produce during covered activities?
- § 112.114What requirements apply to dropped covered produce?
- § 112.115What measures must I take when packaging covered produce?
- § 112.116What measures must I take when using food-packing (including food packaging) material?
- Subpart LEquipment, Tools, Buildings, and Sanitation
- § 112.121What equipment and tools are subject to the requirements of this subpart?
- § 112.122What buildings are subject to the requirements of this subpart?
- § 112.123What general requirements apply regarding equipment and tools subject to this subpart?
- § 112.124What requirements apply to instruments and controls used to measure, regulate, or record?
- § 112.125What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?
- § 112.126What requirements apply to my buildings?
- § 112.127What requirements apply regarding domesticated animals in and around a fully-enclosed building?
- § 112.128What requirements apply regarding pest control in buildings?
- § 112.129What requirements apply to toilet facilities?
- § 112.130What requirements apply for hand-washing facilities?
- § 112.131What must I do to control and dispose of sewage?
- § 112.132What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?
- § 112.133What requirements apply to plumbing?
- § 112.134What must I do to control animal excreta and litter from domesticated animals that are under my control?
- § 112.140Under this subpart, what requirements apply regarding records?
- Subpart MSprouts
- § 112.141What commodities are subject to this subpart?
- § 112.142What requirements apply to seeds or beans used to grow sprouts?
- § 112.143What measures must I take for growing, harvesting, packing, and holding sprouts?
- § 112.144What testing must I do during growing, harvesting, packing, and holding sprouts?
- § 112.145What requirements apply to testing the environment for Listeria species or L. monocytogenes?
- § 112.146What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?
- § 112.147What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?
- § 112.148What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?
- § 112.150Under this subpart, what requirements apply regarding records?
- Subpart NAnalytical Methods
- § 112.151What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?
- § 112.152What 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)?
- § 112.153What 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)?
- Subpart ORecords
- § 112.161What general requirements apply to records required under this part?
- § 112.162Where must I store records?
- § 112.163May I use existing records to satisfy the requirements of this part?
- § 112.164How long must I keep records?
- § 112.165What formats are acceptable for the records I keep?
- § 112.166What requirements apply for making records available and accessible to FDA?
- § 112.167Can records that I provide to FDA be disclosed to persons outside of FDA?
- Subpart PVariances
- § 112.171Who may request a variance from the requirements of this part?
- § 112.172How may a State, tribe, or foreign country request a variance from one or more requirements of this part?
- § 112.173What must be included in the Statement of Grounds in a petition requesting a variance?
- § 112.174What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?
- § 112.175Who responds to a petition requesting a variance?
- § 112.176What process applies to a petition requesting a variance?
- § 112.177Can an approved variance apply to any person other than those identified in the petition requesting that variance?
- § 112.178Under what circumstances may FDA deny a petition requesting a variance?
- § 112.179When does a variance approved by FDA become effective?
- § 112.180Under what circumstances may FDA modify or revoke an approved variance?
- § 112.181What procedures apply if FDA determines that an approved variance should be modified or revoked?
- § 112.182What are the permissible types of variances that may be granted?
- Subpart QCompliance and Enforcement
- Subpart RWithdrawal of Qualified Exemption
- § 112.201Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5?
- § 112.202What procedure will FDA use to withdraw an exemption?
- § 112.203What information must FDA include in an order to withdraw a qualified exemption?
- § 112.204What must I do if I receive an order to withdraw a qualified exemption applicable to my farm?
- § 112.205Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm?
- § 112.206What is the procedure for submitting an appeal?
- § 112.207What is the procedure for requesting an informal hearing?
- § 112.208What requirements are applicable to an informal hearing?
- § 112.209Who is the presiding officer for an appeal and for an informal hearing?
- § 112.210What is the timeframe for issuing a decision on an appeal?
- § 112.211When is an order to withdraw a qualified exemption applicable to a farm revoked?
- § 112.213If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?