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e-CFR data is current as of January 19, 2021

Title 21Chapter ISubchapter BPart 112


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION

PART 112—STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

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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?
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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?
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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?
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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?
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Subpart E—AGRICULTURAL WATER

§112.41
What requirements apply to the quality of agricultural water?
§112.42
What requirements apply to my agricultural water sources, water distribution system, and pooling of water?
§112.43
What requirements apply to treating agricultural water?
§112.44
What specific microbial quality criteria apply to agricultural water used for certain intended uses?
§112.45
What measures must I take if my agricultural water does not meet the requirements of §112.41 or §112.44?
§112.46
How often must I test agricultural water that is subject to the requirements of §112.44?
§112.47
Who must perform the tests required under §112.46 and what methods must be used?
§112.48
What measures must I take for water that I use during harvest, packing, and holding activities for covered produce?
§112.49
What alternatives may I establish and use in lieu of the requirements of this subpart?
§112.50
Under this subpart, what requirements apply regarding records?
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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?
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Subpart G-H—[RESERVED]

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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?
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Subpart J—[RESERVED]

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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?
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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?
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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?
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Subpart N—ANALYTICAL METHODS

§112.151
What methods must I use to test the quality of water to satisfy the requirements of §112.46?
§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)?
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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?
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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?
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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?
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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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