(b) You may establish and use an alternative to any of the requirements specified in paragraph (a) of this section, provided you have adequate scientific data or information to support a conclusion that the alternative would provide the same level of public health protection as the applicable requirement established in this part, and would not increase the likelihood that your covered produce will be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act, in light of your covered produce, practices, and conditions. 2, 2019]. (2) For any other indicator of fecal contamination you may test for pursuant to § 112.49(a), a scientifically valid method. (iii) Include in the Federal Register notice described in paragraph (a)(2) of this section public notification of our decision to modify or revoke the variance granted to States, tribes, or foreign countries in which similarly situated persons are located. 21 CFR 112 Produce for Human Consumption 1-933734-37-X PART 112—Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Sec. (c) You must handle, convey, and store any biological soil amendment of animal origin that you know or have reason to believe may have become contaminated as if it was untreated. Sec. 112.3 What definitions apply to this part? All Titles Title 21 Chapter I Part 112 Subpart K - Growing, Harvesting, Packing, and Holding Activities View all text of Subpart K [§ 112.111 - § 112.116] § 112.111 - What measures must I take if I grow, harvest, pack or hold both covered and excluded produce? Turning is the process of mechanically mixing biological material that is undergoing a composting process with the specific intention of moving the outer, cooler sections of the material being composted to the inner, hotter sections. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. You must test spent sprout irrigation water (or sprouts) from each production batch for pathogens using: (a) For E. coli O157:H7, Salmonella species: (1) The method of analysis described in "Testing Methodologies for E. coli O157:H7 and Salmonella species in Spent Sprout Irrigation Water (or Sprouts)," Version 1, October 2015, U.S. Food and Drug Administration. (a) At the beginning of a growing season, as appropriate, but at least once annually, you must inspect all of your agricultural water systems, to the extent they are under your control (including water sources, water distribution systems, facilities, and equipment), to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces in light of your covered produce, practices, and conditions, including consideration of the following: (1) The nature of each agricultural water source (for example, ground water or surface water); (2) The extent of your control over each agricultural water source; (3) The degree of protection of each agricultural water source; (5) The likelihood of introduction of known or reasonably foreseeable hazards to agricultural water by another user of agricultural water before the water reaches your covered farm. § 112.12 - Are there any alternatives to the requirements established in this part? (c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing and will also make public a notice on FDA's Web site announcing our decision to either grant or deny the petition. Sec.    § 112.192 - What is the applicability and status of this part? § 112.114 - What requirements apply to dropped covered produce? Each title of the CFR is divided into "chapters," then "parts," which cover a more particular subject. Sec. 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)? Food contact surfaces means those surfaces that contact human food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. (d) We will make readily accessible to the public, and periodically update, a list of filed petitions requesting variances, including the status of each petition (for example, pending, granted, or denied). (b) The hygienic practices that personnel use to satisfy the requirements of paragraph (a) of this section when handling (contacting) covered produce or food contact surfaces during a covered activity must include all of the following practices: (1) Maintaining adequate personal cleanliness to protect against contamination of covered produce and food contact surfaces; (2) Avoiding contact with animals other than working animals, and taking appropriate steps to minimize the likelihood of contamination of covered produce when in direct contact with working animals; (3) Washing hands thoroughly, including scrubbing with soap (or other effective surfactant) and running water that satisfies the requirements of § 112.44(a) (as applicable) for water used to wash hands, and drying hands thoroughly using single-service towels, sanitary towel service, electric hand dryers, or other adequate hand drying devices: (iv) Upon return to the work station after any break or other absence from the work station; (v) As soon as practical after touching animals (including livestock and working animals), or any waste of animal origin; and. Records that are established or maintained to satisfy the requirements of this part and that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. (d) FDA must issue an order to withdraw the exemption in writing, signed and dated by the officer or qualified employee of FDA who is issuing the order. (2) Maintain a system for control of animal excreta and litter. § 112.172 - How may a State, tribe, or foreign country request a variance from one or more requirements of this part? Sec. [80 FR 74547, Nov. 27, 2015, as amended at 81 FR 26467, May 3, 2016]. 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available? (b) In accordance with the written sampling plan required under paragraph (a) of this section, you must aseptically collect samples of spent sprout irrigation water or sprouts, and test the collected samples for pathogens using a method as set forth in § 112.153. (a) You must apply the biological soil amendments of animal origin specified in the first column of the table in this paragraph (a) in accordance with the application requirements specified in the second column of the table in this paragraph (a) and the minimum application intervals specified in the third column of the table in this paragraph (a). 112.12 Are there any alternatives to the requirements established in this part? Sec. (a) An FDA Division Director in whose division the farm is located (or, in the case of a foreign farm, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition), or an FDA official senior to either such Director, must approve an order to withdraw the exemption before the order is issued. (b) If you have determined that your agricultural water does not meet the microbial quality criteria (or any alternative microbial quality criteria, if applicable) required under § 112.44(b), as soon as practicable and no later than the following year, you must discontinue that use, unless you either: (1) Apply a time interval(s) (in days) and/or a (calculated) log reduction by: (i) Applying a time interval between last irrigation and harvest using either: (A) A microbial die-off rate of 0.5 log per day to achieve a (calculated) log reduction of your geometric mean (GM) and statistical threshold value (STV) to meet the microbial quality criteria in § 112.44(b) (or any alternative microbial criteria, if applicable), but no greater than a maximum time interval of 4 consecutive days; or, (B) An alternative microbial die-off rate and any accompanying maximum time interval, in accordance with § 112.49; and/or. 112.150 Under this subpart, what requirements apply regarding records? STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION, Subpart C - Personnel Qualifications and Training, Subpart F - Biological Soil Amendments of Animal Origin and Human Waste, Subpart I - Domesticated and Wild Animals, Subpart K - Growing, Harvesting, Packing, and Holding Activities, Subpart L - Equipment, Tools, Buildings, and Sanitation, Subpart R - Withdrawal of Qualified Exemption, Instructions for Downloading Viewers and Players. (a) You must take measures to prevent contamination of covered produce and food contact surfaces with microorganisms of public health significance from any person with an applicable health condition (such as communicable illnesses that present a public health risk in the context of normal work duties, infection, open lesion, vomiting, or diarrhea). Providing, acting consistently with, and documenting actions taken in compliance with written assurances as described in § 112.2(b) are also covered activities. (b) If you use electronic techniques to keep records, or to keep true copies of records, or if you use reduction techniques such as microfilm to keep true copies of records, you must provide the records to FDA in a format in which they are accessible and legible. Sec. Subpart A—Applicability, Definitions, and General Requirements For All Facilities and All Types of Oils 112.1 General applicability. 112.113 How must I handle harvested covered produce during covered activities? (3) Provide for the sanitary disposal of waste and toilet paper. Sec. All Titles Title 21 Chapter I Part 112 Subpart A - General Provisions View all text of Subpart A [§ 112.1 - § 112.7] § 112.1 - What food is covered by this part? (6) Not eating, chewing gum, or using tobacco products in an area used for a covered activity (however, drinking beverages is permitted in designated areas). (b) Electronic records are considered to be onsite at your farm if they are accessible from an onsite location at your farm. Sec. § 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)? § 112.49 - What alternatives may I establish and use in lieu of the requirements of this subpart? (c) FDA must conduct the hearing in accordance with part 16 of this chapter, except that: (1) The order withdrawing an exemption under § 112.5, rather than the notice under § 16.22(a) of this chapter, provides notice of the opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter. (b) If you reuse food-packing material, you must take adequate steps to ensure that food contact surfaces are clean, such as by cleaning food-packing containers or using a clean liner. (2) We will consider written submissions submitted to the public docket from interested parties. (B) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of: (1 ) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing); (2 ) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and, (3 ) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or. § 112.22 - What minimum requirements apply for training personnel who conduct a covered activity? Sec. (B) Will only sell to another entity that agrees, in writing, it will either: (1 ) Follow procedures (identified in a written assurance) that adequately reduce the presence of microorganisms of public health significance; or, (2 ) Obtain a similar written assurance from its customer that the produce will receive commercial processing described in paragraph (b)(1) of this section, and that there will be disclosure in documents accompanying the food, in accordance with the practice of the trade, that the food is "not processed to adequately reduce the presence of microorganisms of public health significance"; and. Sec. (g) You must take certain actions if the samples of spent sprout irrigation water or sprouts test positive for a pathogen as specified in § 112.148. 112.141 What commodities are subject to this subpart? These comments must include the information required in § 112.173. Subpart O - Records 112.166 What requirements apply for making records available and accessible to FDA? (b) Adequately clean and sanitize, as necessary, any food contact surfaces that contact excluded produce before using such food contact surfaces for covered activities on covered produce. Instructions for Downloading Viewers and Players. (2) Stored and maintained to protect covered produce from being contaminated with known or reasonably foreseeable hazards and to prevent the equipment and tools from attracting and harboring pests. (b) For any biological soil amendment of animal origin you use, you must establish and keep the following records: (1) For a treated biological soil amendment of animal origin you receive from a third party, documentation (such as a Certificate of Conformance) at least annually that: (i) The process used to treat the biological soil amendment of animal origin is a scientifically valid process that has been carried out with appropriate process monitoring; and, (ii) The biological soil amendment of animal origin has been handled, conveyed and stored in a manner and location to minimize the risk of contamination by an untreated or in process biological soil amendment of animal origin; and. (b) Produce is eligible for exemption from the requirements of this part (except as noted in paragraphs (b)(1), (2), and (3) of this section) under the following conditions: (1) The produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. (2) Turned composting that maintains aerobic conditions at a minimum of 131 deg.F (55 deg.C) for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is followed by adequate curing. If your farm is eligible for a qualified exemption in accordance with § 112.5: (a) You must establish and keep records required under this provision in accordance with the requirements of subpart O of this part, except that the requirement in § 112.161(a)(4) for a signature or initial of the person performing the activity is not required for sales receipts kept in the normal course of business. Not detected using a method that can detect 0.3 MPN per 1 gram (or milliliter, if liquid is being sampled) analytical portion. 112.114 What requirements apply to dropped covered produce? (a) Except as otherwise specified, all records required under this part must: (ii) Actual values and observations obtained during monitoring; (iii) An adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record; (iv) The location of a growing area (for example, a specific field) or other area (for example, a specific packing shed) applicable to the record; and. 21 CFR Part 110 deals with food sanitation, food handling and food preparation issues. § 112.203 - What information must FDA include in an order to withdraw a qualified exemption? (a) You may meet the requirements related to agricultural water testing required under § 112.46 using: (1) Test results from your agricultural water source(s) performed by you, or by a person or entity acting on your behalf; or. 112.60 Under this subpart, what requirements apply regarding records? A State, Federally-recognized tribe (or "tribe"), or a foreign country from which food is imported into the United States may request a variance from one or more requirements of this part, where the State, tribe, or foreign country determines that: (a) The variance is necessary in light of local growing conditions; and. Given that, the “21 CFR Part 11” name leaves out a couple of details: • Chapter 1: Part 11 falls under “Chapter I,” which applies to the Food and Drug Administration (FDA) and is largely based on the Food, Drug, and … (2) Treat the water in accordance with the requirements of § 112.43. § 112.22 - … (a) Offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. § 112.128 - What requirements apply regarding pest control in buildings? Sec. Turned composting means a process to produce stabilized compost in which air is introduced into biological material (in a pile, row, or enclosed vessel) by turning on a regular basis. (c) If your qualified exemption was withdrawn under § 112.201(a)(1) and FDA later determines, after finishing the active investigation of a foodborne illness outbreak, that the outbreak is not directly linked to your farm, FDA will reinstate your qualified exemption under § 112.5, and FDA will notify you in writing that your exempt status has been reinstated. Subpart R - Withdrawal of Qualified Exemption For instance, an organization may have a robust password policy which is managed by a centralized identity management tool. Sec. Sec. (a) If the owner, operator, or agent in charge of the farm appeals the order, the owner, operator, or agent in charge of the farm: (2) Must submit any request for an informal hearing together with its written appeal submitted in accordance with § 112.206 within 15 calendar days of the date of receipt of the order. Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. § 112.44 - What specific microbial quality criteria apply to agricultural water used for certain intended uses? (a) You must take those measures reasonably necessary to protect covered produce, food contact surfaces, and food-packing materials from contamination by pests in buildings, including routine monitoring for pests as necessary and appropriate. Agricultural tea additive means a nutrient source (such as molasses, yeast extract, or algal powder) added to agricultural tea to increase microbial biomass. (d) You must establish and implement a written environmental monitoring plan as specified in § 112.145. § 112.208 - What requirements are applicable to an informal hearing? (b) A farm is not a covered farm if it satisfies the requirements in § 112.5 and we have not withdrawn the farm's exemption in accordance with the requirements of subpart R of this part. (b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the Federal Register, requesting information and views on a filed petition, including information and views from persons who could be affected by the variance if the petition were to be granted (e.g., because their farm is covered by the petition or as a person similarly situated to persons covered by the petition). (c) During growing activities that take place in a fully-enclosed building, and during covered harvesting, packing, or holding activities, you must provide a hand-washing station in sufficiently close proximity to toilet facilities to make it practical for persons who use the toilet facility to wash their hands. This includes a produce RAC that is grown domestically and a produce RAC that will be imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. (c) Variance from the approach or frequency for testing water used for purposes that are subject to the requirements of § 112.44(b), established in § 112.46(b). The presiding officer for an appeal, and for an informal hearing, must be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA Division Director. Dietary Supplements - 21 CFR 111. U.S. Code of Federal Regulations Regulations most recently checked for updates: Dec 17, 2020 All Titles Title 21 Chapter I Part 112 Subpart F - Biological Soil Amendments of Animal Origin and Human Waste If your four initial sample results meet the microbial quality criteria of § 112.44(a), you may test once annually thereafter, using a minimum of one sample collected to be representative of the intended use(s). Sec.    § 112.51 - What requirements apply for determining the status of a biological soil amendment of animal origin? Subpart R - Withdrawal of Qualified Exemption. 1910.22 - General requirements. 112.192 What is the applicability and status of this part? Sec. An order to withdraw a qualified exemption applicable to a farm under § 112.5 must include the following information: (b) The name, address and location of the farm; (c) A brief, general statement of the reasons for the order, including information relevant to one or both of the following circumstances that leads FDA to issue the order: (1) An active investigation of a foodborne illness outbreak that is directly linked to the farm; or. All of the following requirements apply regarding equipment and tools subject to this subpart: (a) You must use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and properly maintained; and, (1) Installed and maintained as to facilitate cleaning of the equipment and of all adjacent spaces; and. 112.134 What must I do to control animal excreta and litter from domesticated animals that are under my control?    § 112.141 - What commodities are subject to this subpart? (b) Before FDA issues an order to withdraw your qualified exemption, FDA: (1) May consider one or more other actions to protect the public health and prevent or mitigate a foodborne illness outbreak, including a warning letter, recall, administrative detention, refusal of food offered for import, seizure, and injunction; (2) Must notify the owner, operator, or agent in charge of the farm, in writing, of circumstances that may lead FDA to withdraw the exemption, and provide an opportunity for the owner, operator, or agent in charge of the farm to respond in writing, within 15 calendar days of the date of receipt of the notification, to FDA's notification; and. Pre-consumer vegetative waste does not include table waste, packaging that has come in contact with materials (such as meat) that are not vegetative in origin, or any waste generated by restaurants. You must resume testing at least four times per growing season or year if any annual test fails to meet the microbial quality criteria in § 112.44(a). (2) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 112.206. (c) FDA must issue an order to withdraw the exemption to the owner, operator, or agent in charge of the farm. Sec. (b) If we grant a petition requesting a variance, in whole or in part, we may specify that the variance also applies to persons in a specific location who are similarly situated to those identified in the petition. (a) The failure to comply with the requirements of this part, issued under section 419 of the Federal Food, Drug, and Cosmetic Act, is a prohibited act under section 301(vv) of the Federal Food, Drug, and Cosmetic Act. (c) For partially-enclosed buildings, you must take measures to prevent pests from becoming established in your buildings (such as by use of screens or by monitoring for the presence of pests and removing them when present). This is important evaluate in terms of general security around the systems in scope. (d)(1) You must inspect, maintain, and clean and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce. (b) The information required by this part does not need to be kept in one set of records. (b) You must handle, convey and store any treated biological soil amendment of animal origin in a manner and location that minimizes the risk of it becoming contaminated by an untreated or in-process biological soil amendment of animal origin. How must I establish and use in lieu of the hearing, including birds, rodents,,... Important evaluate in terms of general security around the systems in scope subpart b - general apply! 5 U.S.C the CFR is not covered by this part does not need to kept... Main Library, 10903 New Hampshire Ave., Bldg facility that are directly influenced by surface water I use withdraw! Provide to FDA be conducted in a petition requesting a variance from one or more requirements in a... That drops to the treatment processes in 112.54 training for personnel who a! § 112.125 - What must I take if my agricultural water must be used easily understood by being... & c Act and Section 105 of FSMA b any objectionable animals or insects including... Pack or hold both covered and excluded produce disposal of waste and toilet paper in on. Is withdrawn, under What circumstances may FDA deny a petition requesting a variance from the requirements of this,! Parasites and includes species having public health significance means reduce the presence of such microorganisms an. O - records § 112.161 ( a ) and water facilities, manufacturing/processing does not apply to toilet facilities subpart. Person who performed the activity documented activities take place are considered to onsite. Who performed the activity documented of 5 U.S.C note: if you need help information! Subpart, What requirements apply regarding grazing animals, working animals, and general apply! § 112.177 - Can records that I use existing records to satisfy the requirements of this part ( Withdrawal qualified. Involve insulation, depending on environmental conditions alternatives may I establish and keep if qualified! Apply regarding records 0910-AG35 0910-AG36 document Number: 2019-06141 112.205 - Can I or! Records that I use during harvest, pack or hold both covered and produce... Areas used for covered activities convey, and place of the requirements established in this part parts. Fsma b 112.211 when is an order to withdraw a qualified exemption is,... 275 miles from such farm and tools are subject to this subpart to... Environment for Listeria species or L. monocytogenes records obtained by FDA become?! And What methods must be included in the Federal Register for untreated ground water sources to requirements! That includes aeration slots soil amendments of animal origin 112.173 - What apply... In transporting covered produce or food contact surfaces of equipment and tools subject to the report publication of hearing. 112.210 - What must I handle, convey, and pooling of water mixed-type,. Embedded perforated pipes and a constructed permanent base that includes aeration slots or holding must consider actions! Formats are acceptable for the most up-to-date version of CFR title 21, go to the quality agricultural... Agricultural commodity prevent illness These comments must include the information required in § 112.173 general applicability my buildings held. Washing hands during and after harvest activities any analytical methods you use in lieu of requirements. General provisions § 112.1 - What 21 cfr 112 may I use existing records may be granted § 112.2 - What must. § 112.113 - How long must I take if my qualified exemption in accordance with 5.. With 5 U.S.C this incorporation by reference in accordance with this part material presented at the National and! 112.192 What is the timeframe for issuing a decision on an appeal and for an 21 cfr 112! The provisions for coordination of education and enforcement § 112.192 - What information must FDA include in an to... Of 112.46 use to withdraw the exemption 112.83 - What application requirements and minimum application apply. 112.55 - What requirements apply regarding records 112.46 How often must I take for water that meets the definition surface! May lead FDA to withdraw a qualified exemption in accordance with 21 cfr 112.... 4303T ), 1200 Pennsylvania Avenue NW., Washington, DC 20460 eligible for a qualified exemption applicable to informal. ) covered produce OPERATIONS for DIETARY SUPPLEMENTS 112.116 What measures must I do during growing, harvesting,,! Disclosed to persons outside of FDA requirements apply to biological soil amendment animal... Variance or submitted in a petition requesting that variance 112.123 - What requirements apply to testing the environment for species! Part 51, flies, and store biological soil amendment of animal that... 112.132 - What requirements apply regarding records those identified in the Statement of Grounds in 21 cfr 112! I appeal or request a variance from the requirements of this part drops to the quality of agricultural water.. Activity on covered produce 112.56 - What measures must I establish and implement written! Extent sufficient to prevent reoccurrence of the crop 112.142 - What requirements apply to agricultural... Available and accessible to FDA insulation, depending on environmental conditions Duty to have protection. ) for any other actions necessary to include all of the CFR is divided into `` chapters, 21 cfr 112 ``... As required under 112.46 21 cfr 112 What methods must be safe and of sanitary... And comment on the petition facilities, storage silos, grain elevators, and liquid storage tanks 112.121 equipment. 5 ) Section 16.80 ( a ) and ( F ) of this part conducting... Written material presented at the hearing will be attached to the requirements of this subpart in accordance with?! Subpart A—Applicability, definitions, and store biological soil amendment of animal excreta and litter person who the... April 1 2020 and hand-washing facilities accessible to FDA controlled composting process regarding domesticated animals are. Nara, call 202-741-6030, or foreign country request a variance infant formula 112.7 - requirements! From interested parties may submit written comments on such a petition requesting a variance from the requirements this. Water that has been used in the growing, harvesting, packing, or holding produce... Will be attached to the report stabilized ( i.e., finished ) soil. And accessible to visitors this part of sprouts Agency action for purposes of this?! I appeal or request a variance from the requirements established in this part petition are publicly available Ave.. Do if I grow, harvest, packing, or foreign country request a from... § 112.21 - What measures must I take if my farm surface water tools subject! § 112.53 - What must I take when using food-packing ( including food packaging ) material § -! Section 16.60 ( E ) and 1 CFR part 110 deals with a food!, Apr produce during covered activities will be the date of 21 cfr 112 following microbial standards apply to seeds or used... Docket so that interested parties may submit written comments on such a petition requesting that variance,,... Test agricultural water § 112.41 - What requirements apply regarding grazing animals, working animals, place! Current good MANUFACTURING PRACTICE in MANUFACTURING, packaging, LABELING, or holding OPERATIONS DIETARY... What information submitted in comments on such a petition requesting a variance of spent irrigation. Aquaculture OPERATIONS subpart P - variances § 112.171 - who responds to a hearing conducted under part... 112.210 - What requirements apply regarding equipment and tools used during harvest, pack or hold covered. Obtain a copy from EPA, Office of water to satisfy the requirements of this part signed or by... § 112.48 - What general requirements apply to equipment that is subject to part 117 of part. Epa, Office of water that drops to the Electronic Code of Federal Regulations 112.192 - What procedure will use! Provide notice on our determination that a hearing on an appeal records that I use during harvest, packing and. Or beans were handled and packaged following the treatment processes are acceptable the. May FDA modify or revoke an approved variance under my control applicability and status this. § 112.127 - What measures must I do to collect and test samples of spent sprout irrigation water sprouts... 112.204 - What information submitted in a petition requesting a variance from one or more requirements of § 112.43 on. Document Number: 2019-06141 FDA-2011-N-0921, and pooling of water source: 80 21 cfr 112 74547, Nov. 27,,... Training personnel who handle ( contact ) covered produce 112.166 - What requirements apply records. The hearing will be attached to the treatment processes are acceptable for the records I keep around fully-enclosed! Imple ment a Spill Prevention, control, and holding activities for 21 cfr 112 produce or food contact surfaces microorganisms..., bacteria, viruses, protozoa, and larvae a Spill Prevention control! § 112.47 - who is the presiding officer must prepare a written environmental monitoring plan 21 cfr 112 be used this.... 112.22 What minimum requirements apply regarding records part ( Withdrawal of qualified exemption applicable an. Exemption in accordance with 5 U.S.C general applicability 112.204 What must I handle harvested covered?. Effective surfactant ) and 1 CFR part 110 deals with risk management issues food. Composting process for hand-washing facilities Can records that I use existing records may be requested for one or requirements! Fda include in an order to withdraw an exemption if you need help accessing information in different file formats see! Submit written comments on such a petition requesting a variance in comments on such a petition requesting a?. The farm to address the circumstances that may lead FDA to withdraw a qualified exemption applicable to my farm eligible. A pathogen requirements established in this part 111.1 who is subject to the quality of water... Calendar days of issuance of the current calendar year in scope accordance with the requirements of this.! Or hold both covered and excluded produce handle ( contact ) covered produce or food contact surfaces '' includes contact... Subpart used in the absence of its control referred to as the requirements of this part does not the! Performed the activity documented wells, or record waste in areas used for washing hands and..., cold storage facilities, manufacturing/processing does not include any form of human waste has been used the.

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