Home/CFR/Title 21/Part 112
FEDERAL · 21 CFR

Part 112 — Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

102 sections · Title 21: Food and Drugs

§ 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?
§ 112.11What general requirements apply to persons who are subject to this part?
§ 112.12Are there any alternatives to the requirements established in this part?
§ 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?
§ 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?
§ 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?
§ 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?
§ 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?
§ 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?
§ 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?
§ 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?
§ 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)?
§ 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?
§ 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?
§ 112.192What is the applicability and status of this part?
§ 112.193What are the provisions for coordination of education and enforcement?
§ 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?