21 CFR Part 112
PART 112—STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
- PART 112—STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter B—Food 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
- § 112.11 What general requirements apply to persons who are subject to this part?
- § 112.12 Are there any alternatives to the requirements established in this part?
- 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?
- §§ 112.48-112.49 [Reserved]
- § 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 G-H [Reserved]
- 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 J [Reserved]
- 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
- § 112.192 What is the applicability and status of this part?
- § 112.193 What are the provisions for coordination of education 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?
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