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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
 
PART 112STANDARDS 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?

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.

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