| 21:2.0.1.1.12.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:2.0.1.1.12.1.1.1 | SECTION 112.1
| 112.1 What food is covered by this part | |
| 21:2.0.1.1.12.1.1.2 | SECTION 112.2
| 112.2 What produce is not covered by this part | |
| 21:2.0.1.1.12.1.1.3 | SECTION 112.3
| 112.3 What definitions apply to this part | |
| 21:2.0.1.1.12.1.1.4 | SECTION 112.4
| 112.4 Which farms are subject to the requirements of this part | |
| 21:2.0.1.1.12.1.1.5 | SECTION 112.5
| 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 | |
| 21:2.0.1.1.12.1.1.6 | SECTION 112.6
| 112.6 What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5 | |
| 21:2.0.1.1.12.1.1.7 | SECTION 112.7
| 112.7 What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5 | |
| 21:2.0.1.1.12.2 | SUBPART B
| Subpart B - General Requirements | |
| 21:2.0.1.1.12.2.1.1 | SECTION 112.11
| 112.11 What general requirements apply to persons who are subject to this part | |
| 21:2.0.1.1.12.2.1.2 | SECTION 112.12
| 112.12 Are there any alternatives to the requirements established in this part | |
| 21:2.0.1.1.12.3 | SUBPART C
| Subpart C - Personnel Qualifications and Training | |
| 21:2.0.1.1.12.3.1.1 | SECTION 112.21
| 112.21 What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces | |
| 21:2.0.1.1.12.3.1.2 | SECTION 112.22
| 112.22 What minimum requirements apply for training personnel who conduct a covered activity | |
| 21:2.0.1.1.12.3.1.3 | SECTION 112.23
| 112.23 What requirements apply regarding supervisors | |
| 21:2.0.1.1.12.3.1.4 | SECTION 112.30
| 112.30 Under this subpart, what requirements apply regarding records | |
| 21:2.0.1.1.12.4 | SUBPART D
| Subpart D - Health and Hygiene | |
| 21:2.0.1.1.12.4.1.1 | SECTION 112.31
| 112.31 What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance | |
| 21:2.0.1.1.12.4.1.2 | SECTION 112.32
| 112.32 What hygienic practices must personnel use | |
| 21:2.0.1.1.12.4.1.3 | SECTION 112.33
| 112.33 What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance | |
| 21:2.0.1.1.12.5 | SUBPART E
| Subpart E - Agricultural Water | |
| 21:2.0.1.1.12.5.1.1 | SECTION 112.41
| 112.41 What requirements apply to the quality of agricultural water | |
| 21:2.0.1.1.12.5.1.2 | SECTION 112.42
| 112.42 What requirements apply to my agricultural water sources, water distribution system, and pooling of water | |
| 21:2.0.1.1.12.5.1.3 | SECTION 112.43
| 112.43 What requirements apply to treating agricultural water | |
| 21:2.0.1.1.12.5.1.4 | SECTION 112.44
| 112.44 What specific microbial quality criteria apply to agricultural water used for certain intended uses | |
| 21:2.0.1.1.12.5.1.5 | SECTION 112.45
| 112.45 What measures must I take if my agricultural water does not meet the requirements of § 112.41 or § 112.44 | |
| 21:2.0.1.1.12.5.1.6 | SECTION 112.46
| 112.46 How often must I test agricultural water that is subject to the requirements of § 112.44 | |
| 21:2.0.1.1.12.5.1.7 | SECTION 112.47
| 112.47 Who must perform the tests required under § 112.46 and what methods must be used | |
| 21:2.0.1.1.12.5.1.8 | SECTION 112.48
| 112.48 What measures must I take for water that I use during harvest, packing, and holding activities for covered produce | |
| 21:2.0.1.1.12.5.1.9 | SECTION 112.49
| 112.49 What alternatives may I establish and use in lieu of the requirements of this subpart | |
| 21:2.0.1.1.12.5.1.10 | SECTION 112.50
| 112.50 Under this subpart, what requirements apply regarding records | |
| 21:2.0.1.1.12.6 | SUBPART F
| Subpart F - Biological Soil Amendments of Animal Origin and Human Waste | |
| 21:2.0.1.1.12.6.1.1 | SECTION 112.51
| 112.51 What requirements apply for determining the status of a biological soil amendment of animal origin | |
| 21:2.0.1.1.12.6.1.2 | SECTION 112.52
| 112.52 How must I handle, convey, and store biological soil amendments of animal origin | |
| 21:2.0.1.1.12.6.1.3 | SECTION 112.53
| 112.53 What prohibitions apply regarding use of human waste | |
| 21:2.0.1.1.12.6.1.4 | SECTION 112.54
| 112.54 What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce | |
| 21:2.0.1.1.12.6.1.5 | SECTION 112.55
| 112.55 What microbial standards apply to the treatment processes in § 112.54 | |
| 21:2.0.1.1.12.6.1.6 | SECTION 112.56
| 112.56 What application requirements and minimum application intervals apply to biological soil amendments of animal origin | |
| 21:2.0.1.1.12.6.1.7 | SECTION 112.60
| 112.60 Under this subpart, what requirements apply regarding records | |
| 21:2.0.1.1.12.7 | SUBPART G
| Subpart G-H [Reserved] | |
| 21:2.0.1.1.12.8 | SUBPART I
| Subpart I - Domesticated and Wild Animals | |
| 21:2.0.1.1.12.8.1.1 | SECTION 112.81
| 112.81 How do the requirements of this subpart apply to areas where covered activities take place | |
| 21:2.0.1.1.12.8.1.2 | SECTION 112.83
| 112.83 What requirements apply regarding grazing animals, working animals, and animal intrusion | |
| 21:2.0.1.1.12.8.1.3 | SECTION 112.84
| 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 | |
| 21:2.0.1.1.12.9 | SUBPART J
| Subpart J [Reserved] | |
| 21:2.0.1.1.12.10 | SUBPART K
| Subpart K - Growing, Harvesting, Packing, and Holding Activities | |
| 21:2.0.1.1.12.10.1.1 | SECTION 112.111
| 112.111 What measures must I take if I grow, harvest, pack or hold both covered and excluded produce | |
| 21:2.0.1.1.12.10.1.2 | SECTION 112.112
| 112.112 What measures must I take immediately prior to and during harvest activities | |
| 21:2.0.1.1.12.10.1.3 | SECTION 112.113
| 112.113 How must I handle harvested covered produce during covered activities | |
| 21:2.0.1.1.12.10.1.4 | SECTION 112.114
| 112.114 What requirements apply to dropped covered produce | |
| 21:2.0.1.1.12.10.1.5 | SECTION 112.115
| 112.115 What measures must I take when packaging covered produce | |
| 21:2.0.1.1.12.10.1.6 | SECTION 112.116
| 112.116 What measures must I take when using food-packing (including food packaging) material | |
| 21:2.0.1.1.12.11 | SUBPART L
| Subpart L - Equipment, Tools, Buildings, and Sanitation | |
| 21:2.0.1.1.12.11.1.1 | SECTION 112.121
| 112.121 What equipment and tools are subject to the requirements of this subpart | |
| 21:2.0.1.1.12.11.1.2 | SECTION 112.122
| 112.122 What buildings are subject to the requirements of this subpart | |
| 21:2.0.1.1.12.11.1.3 | SECTION 112.123
| 112.123 What general requirements apply regarding equipment and tools subject to this subpart | |
| 21:2.0.1.1.12.11.1.4 | SECTION 112.124
| 112.124 What requirements apply to instruments and controls used to measure, regulate, or record | |
| 21:2.0.1.1.12.11.1.5 | SECTION 112.125
| 112.125 What requirements apply to equipment that is subject to this subpart used in the transport of covered produce | |
| 21:2.0.1.1.12.11.1.6 | SECTION 112.126
| 112.126 What requirements apply to my buildings | |
| 21:2.0.1.1.12.11.1.7 | SECTION 112.127
| 112.127 What requirements apply regarding domesticated animals in and around a fully-enclosed building | |
| 21:2.0.1.1.12.11.1.8 | SECTION 112.128
| 112.128 What requirements apply regarding pest control in buildings | |
| 21:2.0.1.1.12.11.1.9 | SECTION 112.129
| 112.129 What requirements apply to toilet facilities | |
| 21:2.0.1.1.12.11.1.10 | SECTION 112.130
| 112.130 What requirements apply for hand-washing facilities | |
| 21:2.0.1.1.12.11.1.11 | SECTION 112.131
| 112.131 What must I do to control and dispose of sewage | |
| 21:2.0.1.1.12.11.1.12 | SECTION 112.132
| 112.132 What must I do to control and dispose of trash, litter, and waste in areas used for covered activities | |
| 21:2.0.1.1.12.11.1.13 | SECTION 112.133
| 112.133 What requirements apply to plumbing | |
| 21:2.0.1.1.12.11.1.14 | SECTION 112.134
| 112.134 What must I do to control animal excreta and litter from domesticated animals that are under my control | |
| 21:2.0.1.1.12.11.1.15 | SECTION 112.140
| 112.140 Under this subpart, what requirements apply regarding records | |
| 21:2.0.1.1.12.12 | SUBPART M
| Subpart M - Sprouts | |
| 21:2.0.1.1.12.12.1.1 | SECTION 112.141
| 112.141 What commodities are subject to this subpart | |
| 21:2.0.1.1.12.12.1.2 | SECTION 112.142
| 112.142 What requirements apply to seeds or beans used to grow sprouts | |
| 21:2.0.1.1.12.12.1.3 | SECTION 112.143
| 112.143 What measures must I take for growing, harvesting, packing, and holding sprouts | |
| 21:2.0.1.1.12.12.1.4 | SECTION 112.144
| 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts | |
| 21:2.0.1.1.12.12.1.5 | SECTION 112.145
| 112.145 What requirements apply to testing the environment for Listeria species or L. monocytogenes | |
| 21:2.0.1.1.12.12.1.6 | SECTION 112.146
| 112.146 What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes | |
| 21:2.0.1.1.12.12.1.7 | SECTION 112.147
| 112.147 What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens | |
| 21:2.0.1.1.12.12.1.8 | SECTION 112.148
| 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen | |
| 21:2.0.1.1.12.12.1.9 | SECTION 112.150
| 112.150 Under this subpart, what requirements apply regarding records | |
| 21:2.0.1.1.12.13 | SUBPART N
| Subpart N - Analytical Methods | |
| 21:2.0.1.1.12.13.1.1 | SECTION 112.151
| 112.151 What methods must I use to test the quality of water to satisfy the requirements of § 112.46 | |
| 21:2.0.1.1.12.13.1.2 | SECTION 112.152
| 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) | |
| 21:2.0.1.1.12.13.1.3 | SECTION 112.153
| 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) | |
| 21:2.0.1.1.12.14 | SUBPART O
| Subpart O - Records | |
| 21:2.0.1.1.12.14.1.1 | SECTION 112.161
| 112.161 What general requirements apply to records required under this part | |
| 21:2.0.1.1.12.14.1.2 | SECTION 112.162
| 112.162 Where must I store records | |
| 21:2.0.1.1.12.14.1.3 | SECTION 112.163
| 112.163 May I use existing records to satisfy the requirements of this part | |
| 21:2.0.1.1.12.14.1.4 | SECTION 112.164
| 112.164 How long must I keep records | |
| 21:2.0.1.1.12.14.1.5 | SECTION 112.165
| 112.165 What formats are acceptable for the records I keep | |
| 21:2.0.1.1.12.14.1.6 | SECTION 112.166
| 112.166 What requirements apply for making records available and accessible to FDA | |
| 21:2.0.1.1.12.14.1.7 | SECTION 112.167
| 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA | |
| 21:2.0.1.1.12.15 | SUBPART P
| Subpart P - Variances | |
| 21:2.0.1.1.12.15.1.1 | SECTION 112.171
| 112.171 Who may request a variance from the requirements of this part | |
| 21:2.0.1.1.12.15.1.2 | SECTION 112.172
| 112.172 How may a State, tribe, or foreign country request a variance from one or more requirements of this part | |
| 21:2.0.1.1.12.15.1.3 | SECTION 112.173
| 112.173 What must be included in the Statement of Grounds in a petition requesting a variance | |
| 21:2.0.1.1.12.15.1.4 | SECTION 112.174
| 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available | |
| 21:2.0.1.1.12.15.1.5 | SECTION 112.175
| 112.175 Who responds to a petition requesting a variance | |
| 21:2.0.1.1.12.15.1.6 | SECTION 112.176
| 112.176 What process applies to a petition requesting a variance | |
| 21:2.0.1.1.12.15.1.7 | SECTION 112.177
| 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance | |
| 21:2.0.1.1.12.15.1.8 | SECTION 112.178
| 112.178 Under what circumstances may FDA deny a petition requesting a variance | |
| 21:2.0.1.1.12.15.1.9 | SECTION 112.179
| 112.179 When does a variance approved by FDA become effective | |
| 21:2.0.1.1.12.15.1.10 | SECTION 112.180
| 112.180 Under what circumstances may FDA modify or revoke an approved variance | |
| 21:2.0.1.1.12.15.1.11 | SECTION 112.181
| 112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked | |
| 21:2.0.1.1.12.15.1.12 | SECTION 112.182
| 112.182 What are the permissible types of variances that may be granted | |
| 21:2.0.1.1.12.16 | SUBPART Q
| Subpart Q - Compliance and Enforcement | |
| 21:2.0.1.1.12.16.1.1 | SECTION 112.192
| 112.192 What is the applicability and status of this part | |
| 21:2.0.1.1.12.16.1.2 | SECTION 112.193
| 112.193 What are the provisions for coordination of education and enforcement | |
| 21:2.0.1.1.12.17 | SUBPART R
| Subpart R - Withdrawal of Qualified Exemption | |
| 21:2.0.1.1.12.17.1.1 | SECTION 112.201
| 112.201 Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5 | |
| 21:2.0.1.1.12.17.1.2 | SECTION 112.202
| 112.202 What procedure will FDA use to withdraw an exemption | |
| 21:2.0.1.1.12.17.1.3 | SECTION 112.203
| 112.203 What information must FDA include in an order to withdraw a qualified exemption | |
| 21:2.0.1.1.12.17.1.4 | SECTION 112.204
| 112.204 What must I do if I receive an order to withdraw a qualified exemption applicable to my farm | |
| 21:2.0.1.1.12.17.1.5 | SECTION 112.205
| 112.205 Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm | |
| 21:2.0.1.1.12.17.1.6 | SECTION 112.206
| 112.206 What is the procedure for submitting an appeal | |
| 21:2.0.1.1.12.17.1.7 | SECTION 112.207
| 112.207 What is the procedure for requesting an informal hearing | |
| 21:2.0.1.1.12.17.1.8 | SECTION 112.208
| 112.208 What requirements are applicable to an informal hearing | |
| 21:2.0.1.1.12.17.1.9 | SECTION 112.209
| 112.209 Who is the presiding officer for an appeal and for an informal hearing | |
| 21:2.0.1.1.12.17.1.10 | SECTION 112.210
| 112.210 What is the timeframe for issuing a decision on an appeal | |
| 21:2.0.1.1.12.17.1.11 | SECTION 112.211
| 112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked | |
| 21:2.0.1.1.12.17.1.12 | SECTION 112.213
| 112.213 If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption | |