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