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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter B - Food for Human Consumption |
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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
| 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 |
| § 112.40 - What requirements of this subpart apply to my covered farm? |
| § 112.41 - What requirements apply to the quality of my agricultural water? |
| § 112.42 - What requirements apply to inspecting and maintaining my agricultural water systems? |
| § 112.43 - What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)? |
| § 112.44 - What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce? |
| § 112.45 - What measures must I take for agricultural water to reduce the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards? |
| § 112.46 - What requirements apply to treating agricultural water? |
| § 112.47 - Who must perform the tests required under this subpart? |
| § 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? |
| §§ 112.48--112.49 - [Reserved] |
| 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? |
| Subparts G--H - XXX |
| 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? |
| Subpart J - XXX |
| 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 subpart E of this part? |
| § 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? |