Title 21

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 Authority:21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271. Source:80 FR 74547, Nov. 27, 2015, unless otherwise noted. Editorial Note:Nomenclature changes to part 112 appear at 81 FR 49896, July 29, 2016.

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