21 CFR PART 112

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
   § 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
   § 112.41 – 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?

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 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)?

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?