Title 21, Part 112 — Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

What food is covered by this part?

What produce is not covered by this part?

What definitions apply to this part?

Which farms are subject to the requirements of this part?

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?

What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?

What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?

What general requirements apply to persons who are subject to this part?

Are there any alternatives to the requirements established in this part?

What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?

What minimum requirements apply for training personnel who conduct a covered activity?

What requirements apply regarding supervisors?

Under this subpart, what requirements apply regarding records?

What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance?

What hygienic practices must personnel use?

What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance?

What requirements of this subpart apply to my covered farm?

What requirements apply to the quality of my agricultural water?

What requirements apply to inspecting and maintaining my agricultural water systems?

What requirements apply to assessing agricultural water used in growing covered produce (other than sprouts)?

What requirements apply to agricultural water used as sprout irrigation water and in harvesting, packing, and holding covered produce?

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?

What requirements apply to treating agricultural water?

Who must perform the tests required under this subpart?

§§ 112.48-112.49 [Reserved]

Under this subpart, what requirements apply regarding records?

What requirements apply for determining the status of a biological soil amendment of animal origin?

How must I handle, convey, and store biological soil amendments of animal origin?

What prohibitions apply regarding use of human waste?

What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?

What microbial standards apply to the treatment processes in § 112.54?

What application requirements and minimum application intervals apply to biological soil amendments of animal origin?

Under this subpart, what requirements apply regarding records?

How do the requirements of this subpart apply to areas where covered activities take place?

What requirements apply regarding grazing animals, working animals, and animal intrusion?

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?

What measures must I take if I grow, harvest, pack or hold both covered and excluded produce?

What measures must I take immediately prior to and during harvest activities?

How must I handle harvested covered produce during covered activities?

What requirements apply to dropped covered produce?

What measures must I take when packaging covered produce?

What measures must I take when using food-packing (including food packaging) material?

What equipment and tools are subject to the requirements of this subpart?

What buildings are subject to the requirements of this subpart?

What general requirements apply regarding equipment and tools subject to this subpart?

What requirements apply to instruments and controls used to measure, regulate, or record?

What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?

What requirements apply to my buildings?

What requirements apply regarding domesticated animals in and around a fully-enclosed building?

What requirements apply regarding pest control in buildings?

What requirements apply to toilet facilities?

What requirements apply for hand-washing facilities?

What must I do to control and dispose of sewage?

What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?

What requirements apply to plumbing?

What must I do to control animal excreta and litter from domesticated animals that are under my control?

Under this subpart, what requirements apply regarding records?

What commodities are subject to this subpart?

What requirements apply to seeds or beans used to grow sprouts?

What measures must I take for growing, harvesting, packing, and holding sprouts?

What testing must I do during growing, harvesting, packing, and holding sprouts?

What requirements apply to testing the environment for Listeria species or L. monocytogenes?

What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?

What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?

What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?

Under this subpart, what requirements apply regarding records?

What methods must I use to test the quality of water to satisfy the requirements of subpart E of this part?

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)?

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)?

What general requirements apply to records required under this part?

Where must I store records?

May I use existing records to satisfy the requirements of this part?

How long must I keep records?

What formats are acceptable for the records I keep?

What requirements apply for making records available and accessible to FDA?

Can records that I provide to FDA be disclosed to persons outside of FDA?

Who may request a variance from the requirements of this part?

How may a State, tribe, or foreign country request a variance from one or more requirements of this part?

What must be included in the Statement of Grounds in a petition requesting a variance?

What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?

Who responds to a petition requesting a variance?

What process applies to a petition requesting a variance?

Can an approved variance apply to any person other than those identified in the petition requesting that variance?

Under what circumstances may FDA deny a petition requesting a variance?

When does a variance approved by FDA become effective?

Under what circumstances may FDA modify or revoke an approved variance?

What procedures apply if FDA determines that an approved variance should be modified or revoked?

What are the permissible types of variances that may be granted?

What is the applicability and status of this part?

What are the provisions for coordination of education and enforcement?

Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5?

What procedure will FDA use to withdraw an exemption?

What information must FDA include in an order to withdraw a qualified exemption?

What must I do if I receive an order to withdraw a qualified exemption applicable to my farm?

Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm?

What is the procedure for submitting an appeal?

What is the procedure for requesting an informal hearing?

What requirements are applicable to an informal hearing?

Who is the presiding officer for an appeal and for an informal hearing?

What is the timeframe for issuing a decision on an appeal?

When is an order to withdraw a qualified exemption applicable to a farm revoked?

If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?