Title 21 - Food and Drugs

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 in tended 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 forcovered 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?

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.


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1. Subpart A - General Provisions