Title 21 CFR reference

(a) Unless it is excluded from this part under § 112.2, food that is produce within the meaning of this part and that is a raw agricultural commodity (RAC) is covered by this part. 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. (b) For the purpose of this part and subject to the exemptions and qualified exemptions therein, covered produce includes all of the following: (1) Fruits and vegetables such as almonds, apples, apricots, apriums, Artichokes-globe-type, Asian pears, avocados, babacos, bananas, Belgian endive, blackberries, blueberries, boysenberries, brazil nuts, broad beans, broccoli, Brussels sprouts, burdock, cabbages, Chinese cabbages (Bok Choy, mustard, and Napa), cantaloupes, carambolas, carrots, cauliflower, celeriac, celery, chayote fruit, cherries (sweet), chestnuts, chicory (roots and tops), citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), cowpea beans, cress-garden, cucumbers, curly endive, currants, dandelion leaves,…

You must take appropriate measures to minimize the risk of serious adverse health consequences or death from the use of, or exposure to, covered produce, including those measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce, and to provide reasonable assurances that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act on account of such hazards.

i.e.,If you grow, harvest, pack or hold produce that is not covered in this part ( excluded produce in accordance with § 112.2) and also conduct such activities on covered produce, and the excluded produce is not grown, harvested, packed or held in accordance with this part, you must take measures during these covered activities, as applicable, to: (a) Keep covered produce separate from excluded produce (except when covered produce and excluded produce are placed in the same container for distribution); and (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.

You must take all measures reasonably necessary to identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard, including steps to identify and not harvest covered produce that is visibly contaminated with animal excreta. At a minimum, identifying and not harvesting covered produce that is reasonably likely to be contaminated with animal excreta or that is visibly contaminated with animal excreta requires a visual assessment of the growing area and all covered produce to be harvested, regardless of the harvest method used.

You must handle harvested covered produce during covered activities in a manner that protects against contamination with known or reasonably foreseeable hazards—for example, by avoiding, to the degree practicable, contact of cut surfaces of harvested produce with soil.

You must not distribute dropped covered produce. Dropped covered produce is covered produce that drops to the ground before harvest. Dropped covered produce does not include root crops that grow underground (such as carrots), crops that grow on the ground (such as cantaloupe), or produce that is intentionally dropped to the ground as part of harvesting (such as almonds).

Clostridium botulinumYou must package covered produce in a manner that prevents the formation of toxin if such toxin is a known or reasonably foreseeable hazard (such as for mushrooms).

(a) You must use food-packing material that is adequate for its intended use, which includes being: (1) Cleanable or designed for single use; and (2) Unlikely to support growth or transfer of bacteria. (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.

(a) You may establish alternatives to certain specific requirements of subpart E of this part, as specified in § 112.49, provided that you satisfy the requirements of paragraphs (b) and (c) of this section. (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. (c) Scientific data and information used to support an alternative to a requirement specified in paragraph (a) of this section may be developed by you, available in the scientific literature, or available to you through a third party. You must establish and maintain documentation of the scientific data and information on which you rely in accordance with the requirements of subpart O of this part. You are not required to notify or seek prior…

Equipment and tools subject to the requirements of this subpart are those that are intended to, or likely to, contact covered produce; and those instruments or controls used to measure, regulate, or record conditions to control or prevent the growth of microorganisms of public health significance. Examples include knives, implements, mechanical harvesters, waxing machinery, cooling equipment (including hydrocoolers), grading belts, sizing equipment, palletizing equipment, and equipment used to store or convey harvested covered produce (such as containers, bins, food-packing material, dump tanks, flumes, and vehicles or other equipment used for transport that are intended to, or likely to, contact covered produce).

Buildings subject to the requirements of this subpart include: (a) Any fully- or partially-enclosed building used for covered activities, including minimal structures that have a roof but do not have any walls; and (b) Storage sheds, buildings, or other structures used to store food contact surfaces (such as harvest containers and food-packing materials).

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 (b) Equipment and tools must be: (1) Installed and maintained as to facilitate cleaning of the equipment and of all adjacent spaces; and (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. (c) Seams on food contact surfaces of equipment and tools that you use must be either smoothly bonded, or maintained to minimize accumulation of dirt, filth, food particles, and organic material and thus minimize the opportunity for harborage or growth of microorganisms. (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. (2) You must maintain and clean all non-food-contact surfaces of…

Instruments or controls you use to measure, regulate, or record temperatures, hydrogen-ion concentration (pH), sanitizer efficacy or other conditions, in order to control or prevent the growth of microorganisms of public health significance, must be: (a) Accurate and precise as necessary and appropriate in keeping with their purpose; (b) Adequately maintained; and (c) Adequate in number for their designated uses.

Equipment that is subject to this subpart that you use to transport covered produce must be: (a) Adequately clean before use in transporting covered produce; and (b) Adequate for use in transporting covered produce.

(a) All of the following requirements apply regarding buildings: (1) Buildings must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for covered activities to reduce the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards. Buildings must: (i) Provide sufficient space for placement of equipment and storage of materials; (ii) Permit proper precautions to be taken to reduce the potential for contamination of covered produce, food contact surfaces, or packing materials with known or reasonably foreseeable hazards. The potential for contamination must be reduced by effective design including the separation of operations in which contamination is likely to occur, by one or more of the following means: Location, time, partition, enclosed systems, or other effective means; and (2) You must provide adequate drainage in all areas where normal operations release or discharge water or other liquid waste on the ground or floor of the building. (b) You must implement measures to prevent contamination of your covered produce and food contact surfaces in your buildings, as…

(a) You must take reasonable precautions to prevent contamination of covered produce, food contact surfaces, and food-packing materials in fully-enclosed buildings with known or reasonably foreseeable hazards from domesticated animals by: (1) Excluding domesticated animals from fully-enclosed buildings where covered produce, food contact surfaces, or food-packing material is exposed; or (2) Separating domesticated animals in a fully enclosed building from an area where a covered activity is conducted on covered produce by location, time, or partition. (b) Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of the dogs is unlikely to result in contamination of produce, food contact surfaces, or food-packing materials.

(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. (b) For fully-enclosed buildings, you must take measures to exclude pests from your buildings. (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).

All of the following requirements apply to toilet facilities: (a) You must provide personnel with adequate, readily accessible toilet facilities, including toilet facilities readily accessible to growing areas during harvesting activities. (b) Your toilet facilities must be designed, located, and maintained to: (1) Prevent contamination of covered produce, food contact surfaces, areas used for a covered activity, water sources, and water distribution systems with human waste; (2) Be directly accessible for servicing, be serviced and cleaned at a frequency sufficient to ensure suitability of use, and be kept supplied with toilet paper; and (3) Provide for the sanitary disposal of waste and toilet paper. (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.

All of the following requirements apply to hand-washing facilities: (a) You must provide personnel with adequate, readily accessible hand-washing facilities during growing activities that take place in a fully-enclosed building, and during covered harvest, packing, or holding activities. (b) Your hand-washing facilities must be furnished with: (1) Soap (or other effective surfactant); (2) Running water that satisfies the requirements of § 112.44(a) for water used to wash hands; and (3) Adequate drying devices (such as single service towels, sanitary towel service, or electric hand dryers). (c) You must provide for appropriate disposal of waste (for example, waste water and used single-service towels) associated with a hand-washing facility and take appropriate measures to prevent waste water from a hand-washing facility from contaminating covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with known or reasonably foreseeable hazards. (d) You may not use antiseptic hand rubs as a substitute for soap (or other effective surfactant) and water.

All of the following requirements apply for the control and disposal of sewage: (a) You must dispose of sewage into an adequate sewage or septic system or through other adequate means. (b) You must maintain sewage and septic systems in a manner that prevents contamination of covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with known or reasonably foreseeable hazards. (c) You must manage and dispose of leakages or spills of human waste in a manner that prevents contamination of covered produce, and prevents or minimizes contamination of food contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems. (d) After a significant event (such as flooding or an earthquake) that could negatively impact a sewage or septic system, you must take appropriate steps to ensure that sewage and septic systems continue to operate in a manner that does not contaminate covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems.

All of the following requirements apply to the control and disposal of trash, litter, and waste in areas used for covered activities: (a) You must convey, store, and dispose of trash, litter and waste to: (1) Minimize the potential for trash, litter, or waste to attract or harbor pests; and (2) Protect against contamination of covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with known or reasonably foreseeable hazards. (b) You must adequately operate systems for waste treatment and disposal so that they do not constitute a potential source of contamination in areas used for a covered activity.

The plumbing must be of an adequate size and design and be adequately installed and maintained to: (a) Distribute water under pressure as needed, in sufficient quantities, in all areas where used for covered activities, for sanitary operations, or for hand-washing and toilet facilities; (b) Properly convey sewage and liquid disposable waste; (c) Avoid being a source of contamination to covered produce, food contact surfaces, areas used for a covered activity, or agricultural water sources; and (d) Not allow backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for a covered activity, for sanitary operations, or for use in hand-washing facilities.

(a) If you have domesticated animals, to prevent contamination of covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems with animal waste, you must: (1) Adequately control their excreta and litter; and (2) Maintain a system for control of animal excreta and litter. (b) [Reserved]

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part. (b) You must establish and keep documentation of the date and method of cleaning and sanitizing of equipment subject to this subpart used in: (1) Growing operations for sprouts; and (2) Covered harvesting, packing, or holding activities.

The requirements of this subpart apply to growing, harvesting, packing, and holding of all sprouts, except soil- or substrate-grown sprouts harvested without their roots.

In addition to the requirements of this part, all of the following requirements apply to seeds or beans used to grow sprouts. (a) You must take measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into or onto seeds or beans that you will use for sprouting. (b) Except as provided in paragraph (c) of this section, if you know or have reason to believe that a lot of seeds or beans may be contaminated with a pathogen (either because it has been associated with foodborne illness; or based on microbial test results, including a positive finding of a pathogen in tests required under § 112.144(b)), you must: (1) Discontinue use of all seeds or beans from that lot for sprout production and ensure that sprouts grown from that lot of seeds or beans do not enter commerce; and (2) Report the information (association with illness and/or findings of microbial testing) to the seed grower, distributor, supplier, or other entity from whom you received the seeds or beans. (c) If your reason to believe that a lot of seeds or beans may be contaminated was based only on microbial test results: (1) You are not required to take the steps set forth in…

You must take all of the following measures for growing, harvesting, packing, and holding sprouts: (a) You must grow, harvest, pack, and hold sprouts in a fully-enclosed building. (b) Any food contact surfaces you use to grow, harvest, pack, or hold sprouts must be cleaned and sanitized before contact with sprouts or seeds or beans used to grow sprouts. (c) You must conduct testing during growing, harvesting, packing, and holding sprouts, as specified in § 112.144. (d) You must establish and implement a written environmental monitoring plan as specified in § 112.145. ListeriaL. monocytogenes(e) You must take certain actions if you detect species or in the growing, harvesting, packing, or holding environment, as specified in § 112.146. (f) You must establish and implement a written sampling plan to test spent sprout irrigation water or sprouts for pathogens as specified in § 112.147. (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.

All of the following testing must be done during growing, harvesting, packing, and holding sprouts: ListeriaL. monocytogenes(a) You must test the growing, harvesting, packing, and holding environment for species or in accordance with the requirements of § 112.145. (b) You must either: E. coliSalmonella(1) Test spent sprout irrigation water from each production batch of sprouts for O157:H7, species, and any pathogens meeting the criteria in paragraph (c) of this section, in accordance with the requirements of § 112.147; or i.e.,E. coliSalmonella(2) If testing spent sprout irrigation water is not practicable (for example, soil-grown sprouts harvested with roots or for hydroponically grown sprouts that use very little water), test each production batch of sprouts at the in-process stage ( while sprouts are still growing) for O157:H7, species, and any pathogens meeting the criteria in paragraph (c) of this section, in accordance with the requirements of § 112.147. E. coliSalmonella(c) In addition to O157:H7 and species, you must conduct tests as provided in paragraph (b) of this section for additional pathogens when the following conditions are met: (1) Testing for the pathogen…

ListeriaL. monocytogenes.All of the following testing requirements apply for the growing, harvesting, packing, and holding environment for species or L. monocytogenes(a) You must establish and implement a written environmental monitoring plan that is designed to identify if it is present in the growing, harvesting, packing, or holding environment. ListeriaL. monocytogenes.(b) Your written environmental monitoring plan must be directed to sampling and testing for either species or (c) Your written environmental monitoring plan must include a sampling plan that specifies: i.e., ListeriaL. monocytogenes(1) What you will test collected samples for ( species or ); (2) How often you will collect environmental samples, which must be no less than monthly, and at what point during production you will collect the samples; and (3) Sample collection sites; the number and location of sampling sites must be sufficient to determine whether measures are effective and must include appropriate food contact surfaces and non-food-contact surfaces of equipment, and other surfaces within the growing, harvesting, packing, and holding environment. ListeriaL. monocytogenes(d) You must aseptically…

ListeriaL. monocytogenesYou must, at a minimum, take the following actions if you detect species or in the growing, harvesting, packing, or holding environment: ListeriaL. monocytogenesListeriaL. monocytogenes(a) Conduct additional testing of surfaces and areas surrounding the area where species or was detected to evaluate the extent of the problem, including the potential for species or to have become established in a niche; (b) Clean and sanitize the affected surfaces and surrounding areas; ListeriaL. monocytogenes(c) Conduct additional sampling and testing to determine whether the species or has been eliminated; (d) Conduct finished product testing when appropriate; (e) Perform any other actions necessary to prevent recurrence of the contamination; and (f) Take appropriate action to prevent any food that is adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act from entering into commerce.

All of the following requirements apply for collecting and testing samples of spent sprout irrigation water or sprouts for pathogens as required in § 112.144(b): (a) You must establish and implement a written sampling plan that identifies the number and location of samples (of spent sprout irrigation water or sprouts) to be collected for each production batch of sprouts to ensure that the collected samples are representative of the production batch when testing for contamination. E. coliSalmonella(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. You must not allow the production batch of sprouts to enter into commerce unless the results of the testing of spent sprout irrigation water or sprouts are negative for O157:H7, species, and, if applicable, a pathogen meeting the criteria in § 112.144(c). E. coliSalmonella(c) Your written sampling plan must include a corrective action plan that at a minimum, requires you to take the actions in § 112.148, and details when and…

E. coliSalmonellaYou must, at a minimum, take the following actions if the samples of spent sprout irrigation water or sprouts test positive for O157:H7, species, or a pathogen meeting the criteria in § 112.144(c): (a) Take appropriate action to prevent any food that is adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act from entering into commerce; (b) Take the steps required in § 112.142(b) with respect to the lot of seeds or beans used to grow the affected production batch of sprouts (except as allowed under § 112.142(c)); (c) Clean and sanitize the affected surfaces and surrounding areas; and (d) Perform any other actions necessary to prevent reoccurrence of the contamination.

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part. (b) You must establish and keep the following records: (1) Documentation of your treatment of seeds or beans to reduce microorganisms of public health significance in the seeds or beans, at your farm; or alternatively, documentation (such as a Certificate of Conformance) from your seed supplier that seeds or beans are treated to reduce microorganisms of public health significance and are appropriately handled and packaged following the treatment, in accordance with the requirements of § 112.142(e); (2) Your written environmental monitoring plan in accordance with the requirements of § 112.145; (3) Your written sampling plan for each production batch of sprouts in accordance with the requirements of § 112.147(a) and (c); (4) Documentation of the results of all analytical tests conducted for purposes of compliance with this subpart; (5) Any analytical methods you use in lieu of the methods that are incorporated by reference in §§ 112.152 and 112.153; and (6) Documentation of actions you take in accordance with §§ 112.142(b) and (c), 112.146, and…

You must test the quality of water using: Escherichia coliE. coliEscherichia colihttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html(a) The method of analysis published by the U.S. Environmental Protection Agency (EPA), “Method 1603: () in Water by Membrane Filtration Using Modified membrane-Thermotolerant Agar (Modified mTEC), EPA-821-R-09-007),” December, 2009. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from EPA, Office of Water (4303T), 1200 Pennsylvania Avenue NW., Washington, DC 20460. You may inspect a copy at FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: ; or (b)(1) A scientifically valid method that is at least equivalent to the method of analysis in § 112.151(a) in accuracy, precision, and sensitivity; or (2) For any other indicator of fecal contamination you may test for pursuant to § 112.49(a), a scientifically…

ListeriaL.monocytogenesYou must test the growing, harvesting, packing, and holding environment for species or using: ListeriaL. monocytogeneshttp://www.fda.gov/fsmahttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html(a) The method of analysis described in “Testing Methodology for species or in Environmental Samples,” Version 1, October 2015, U.S. Food and Drug Administration. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5. You may obtain a copy from, and/or inspect a copy at, the Division of Produce Safety, Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1600; FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039; ; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: ; or (b) A scientifically valid method that is at least equivalent to the method of analysis in § 112.152(a) in accuracy, precision, and sensitivity.

You must test spent sprout irrigation water (or sprouts) from each production batch for pathogens using: E. coliSalmonella(a) For O157:H7, species: E. coliSalmonellahttp://www.fda.gov/fsmahttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html(1) The method of analysis described in “Testing Methodologies for O157:H7 and species in Spent Sprout Irrigation Water (or Sprouts),” Version 1, October 2015, U.S. Food and Drug Administration. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 5. You may obtain a copy from, and/or inspect a copy at, the Division of Produce Safety, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1600; FDA's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039; ; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: ; or (2) A scientifically valid method that is at least equivalent to the method of analysis in §…

(a) Except as otherwise specified, all records required under this part must: (1) Include, as applicable: (i) The name and location of your farm; (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 (v) The date and time of the activity documented; (2) Be created at the time an activity is performed or observed; (3) Be accurate, legible, and indelible; and (4) Be dated, and signed or initialed by the person who performed the activity documented. (b) Records required under §§ 112.7(b), 112.30(b), 112.50(b)(2), (4), and (6), 112.60(b)(2), 112.140(b)(1) and (2), and 112.150(b)(1), (4), and (6), must be reviewed, dated, and signed, within a reasonable time after the records are made, by a supervisor or responsible party. [80 FR 74547, Nov. 27, 2015, as amended at 84 FR 12491, Apr. 2, 2019]

(a) Offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. (b) Electronic records are considered to be onsite at your farm if they are accessible from an onsite location at your farm.

e.g.,(a) Existing records ( records that are kept to comply with other Federal, State, or local regulations, or for any other reason) do not need to be duplicated if they contain all of the required information and satisfy the requirements of this part. Existing records may be supplemented as necessary to include all of the required information and satisfy the requirements of this part. (b) The information required by this part does not need to be kept in one set of records. If existing records contain some of the required information, any new information required by this part may be kept either separately or combined with the existing records.

(a)(1) You must keep records required by this part for at least 2 years past the date the record was created. (2) Records that a farm relies on during the 3-year period preceding the applicable calendar year to satisfy the criteria for a qualified exemption, in accordance with §§ 112.5 and 112.7, must be retained as long as necessary to support the farm's status during the applicable calendar year. (b) Records that relate to the general adequacy of the equipment or processes or records that relate to analyses, sampling, or action plans being used by a farm, including the results of scientific studies, tests, and evaluations, must be retained at the farm for at least 2 years after the use of such equipment or processes, or records related to analyses, sampling, or action plans, is discontinued.

You must keep records as: (a) Original records; (b) True copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records); or (c) Electronic records. 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. Records that satisfy the requirements of this part, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.

(a) You must have all records required under this part readily available and accessible during the retention period for inspection and copying by FDA upon oral or written request, except that you have 24 hours to obtain records you keep offsite and make them available and accessible to FDA for inspection and copying. (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. (c) If your farm is closed for a prolonged period, the records may be transferred to some other reasonably accessible location but must be returned to your farm within 24 hours for official review upon request.

Records obtained by FDA in accordance with this part are subject to the disclosure requirements under part 20 of this chapter.

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 (b) The procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act and to provide the same level of public health protection as the requirements of this part.

i.e.,To request a variance from one or more requirements of this part, the competent authority ( the regulatory authority for food safety) for a State, tribe, or a foreign country must submit a petition under § 10.30 of this chapter.

In addition to the requirements set forth in § 10.30 of this chapter, the Statement of Grounds in a petition requesting a variance must: (a) Provide a statement that the applicable State, tribe, or foreign country has determined that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug and Cosmetic Act and to provide the same level of public health protection as the requirements of this part; (b) Describe with particularity the variance requested, including the persons to whom the variance would apply and the provision(s) of this part to which the variance would apply; (c) Present information demonstrating that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) and to provide the same level of public health protection as the requirements of this part.

We will presume that information submitted in a petition requesting a variance and comments submitted on such a petition, including a request that a variance be applied to its similarly situated persons, does not contain information exempt from public disclosure under part 20 of this chapter and will be made public as part of the docket associated with this request.

The Director or Deputy Directors of the Center for Food Safety and Applied Nutrition (CFSAN), or the Director, Office of Compliance, CFSAN, responds to a request for a variance.

(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a variance. Federal Register,04e.g.,(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the 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 ( because their farm is covered by the petition or as a person similarly situated to persons covered by the petition). (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. (1) If we grant the petition, either in whole or in part, we will specify the persons to whom the variance applies and the provision(s) of this part to which the variance applies. (2) If we deny the petition (including partial denials), our written response to the petitioner and our public notice announcing our decision to deny the petition will explain the reason(s) for the denial. (d) We will make readily accessible to the public, and periodically update, a list of filed…

(a) A State, tribe, or a foreign country that believes that a variance requested by a petition submitted by another State, tribe, or foreign country should also apply to similarly situated persons in its jurisdiction may request that the variance be applied to its similarly situated persons by submitting comments in accordance with § 10.30 of this chapter. These comments must include the information required in § 112.173. If FDA determines that these comments should instead be treated as a separate request for a variance, FDA will notify the State, tribe, or foreign country that submitted these comments that a separate request must be submitted in accordance with §§ 112.172 and 112.173. (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. (c) If we specify that the variance also applies to persons in a specific location who are similarly situated to those identified in the petition, we will inform the applicable State, tribe, or foreign country where the similarly situated persons are located of our decision in writing…

We may deny a variance request if it does not provide the information required under § 112.173 (including the requirements of § 10.30 of this chapter), or if we determine that the variance is not reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug and Cosmetic Act and to provide the same level of public health protection as the requirements of this part.

A variance approved by FDA becomes effective on the date of our written decision on the petition.

We may modify or revoke a variance if we determine that such variance is not reasonably likely to ensure that the produce is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act and to provide the same level of public health protection as the requirements of this part.

(a) We will provide the following notifications: (1) We will notify a State, tribe, or a foreign country directly, in writing at the address identified in its petition, if we determine that a variance granted in response to its petition should be modified or revoked. Our direct, written notification will provide the State, tribe, or foreign country with an opportunity to request an informal hearing under part 16 of this chapter. Federal Register.04(2) We will publish a notice of our determination that a variance should be modified or revoked in the This notice will establish a public docket so that interested parties may submit written comments on our determination. (3) When applicable, we will: (i) Notify in writing any States, tribes, or foreign countries where a variance applies to similarly situated persons of our determination that the variance should be modified or revoked; (ii) Provide those States, tribes, or foreign countries with an opportunity to request an informal hearing under part 16 of this chapter; and Federal Register04(iii) Include in the notice described in paragraph (a)(2) of this section public notification of our decision to modify or revoke the…

A variance(s) may be requested for one or more requirements in subparts A through O of this part. Examples of permissible types of variances include: (a) Variance from the microbial quality criteria when agricultural water is used during growing activities for covered produce (other than sprouts) using a direct water application method, established in § 112.44(b); (b) Variance from the microbial die-off rate that is used to determine the time interval between last irrigation and harvest, and/or the accompanying maximum time interval, established in § 112.45(b)(1)(i); and (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).

(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. (b) The criteria and definitions in this part apply in determining whether a food is: (1) Adulterated within the meaning of: (i) Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that the food has been grown, harvested, packed, or held under such conditions that it is unfit for food; or (ii) Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (2) In violation of section 361 of the Public Health Service Act (42 U.S.C. 264).

Under section 419(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act, FDA coordinates education and enforcement activities by State, territorial, tribal, and local officials by helping develop education, training, and enforcement approaches.

(a) The following produce is not covered by this part: (1) Produce that is rarely consumed raw, specifically the produce on the following exhaustive list: Asparagus; beans, black; beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts. (2) Produce that is produced by an individual for personal consumption or produced for consumption on the farm or another farm under the same management; and (3) Produce that is not a raw agricultural commodity. (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 commercial processing that adequately reduces the presence of…

(a) We may withdraw your qualified exemption under § 112.5: (1) In the event of an active investigation of a foodborne illness outbreak that is directly linked to your farm; or (2) If we determine that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with your farm that are material to the safety of the food that would otherwise be covered produce grown, harvested, packed or held at your farm. (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 (3) Must consider the actions taken by…

(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) Any officer or qualified employee of FDA may issue an order to withdraw the exemption after it has been approved in accordance with paragraph (a) of this section. (c) FDA must issue an order to withdraw the exemption to the owner, operator, or agent in charge of the farm. (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. [80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 24, 2020]

An order to withdraw a qualified exemption applicable to a farm under § 112.5 must include the following information: (a) The date of the order; (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 (2) Conduct or conditions associated with a farm that are material to the safety of the food that would otherwise be covered produce grown, harvested, packed and held at such farm. (d) A statement that the farm must either: (1) Comply with subparts B through O of this part on the date that is 120 calendar days from the date of receipt of the order, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; or (2) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 112.206. (e) A statement that a farm may request that FDA…

The owner, operator, or agent in charge of a farm that receives an order to withdraw a qualified exemption applicable to that farm under § 112.5 must either: (a) Comply with applicable requirements of this part within 120 calendar days of the date from receipt of the order or, if operations have ceased and will not resume within 120 calendar days, before the beginning of operations in the next growing season, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; or (b) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 112.206.

(a) Submission of an appeal, including submission of a request for an informal hearing, will not operate to delay or stay any administrative action, including enforcement action by FDA, unless the Commissioner of Food and Drugs, as a matter of discretion, determines that delay or a stay is in the public interest. (b) If the owner, operator, or agent in charge of the farm appeals the order, and FDA confirms the order: (1) The owner, operator, or agent in charge of the farm must comply with applicable requirements of this part within 120 calendar days from the date of receipt of the order, or, if operations have ceased and will not resume within 120 calendar days, before the beginning of operations in the next growing season, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; and (2) The owner, operator, or agent in charge of the farm is no longer subject to the modified requirements in §§ 112.6 and 112.7.

(a) To appeal an order to withdraw a qualified exemption applicable to a farm under § 112.5, the owner, operator, or agent in charge of the farm must: (1) Submit the appeal in writing to the 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), at the mailing address, email address, or fax number identified in the order within 15 calendar days of the date of receipt of the order; and (2) Respond with particularity to the facts and issues contained in the order, including any supporting documentation upon which the owner, operator or agent in charge of the farm relies. (b) In a written appeal of the order withdrawing an exemption provided under § 112.5, the owner, operator, or agent in charge of the farm may include a written request for an informal hearing as provided in § 112.207. [80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 24, 2020]

(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: (1) May request an informal hearing; and (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. (b) A request for an informal hearing may be denied, in whole or in part, if the presiding officer determines that no genuine and substantial issue of material fact has been raised by the material submitted. If the presiding officer determines that a hearing is not justified, a written notice of the determination will be given to the owner, operator, or agent in charge of the farm explaining the reason for the denial.

If the owner, operator, or agent in charge of the farm requests an informal hearing, and FDA grants the request: (a) The hearing will be held within 15 calendar days after the date the appeal is filed or, if applicable, within a timeframe agreed upon in writing by the owner, operator, or agent in charge of the farm and FDA. (b) The presiding officer may require that a hearing conducted under this subpart be completed within 1 calendar day, as appropriate. (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. (2) A request for a hearing under this subpart must be addressed to the FDA Division Director (or, in the case of a foreign farm, the Director of the Office of Compliance in the Center for Food Safety and Applied Nutrition) as provided in the order withdrawing an exemption. (3) Section 112.209, rather than § 16.42(a) of this chapter, describes the FDA employees…

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. [85 FR 16552, Mar. 24, 2020]

All of the following requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces: (a) All personnel (including temporary, part time, seasonal, and contracted personnel) who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must receive adequate training, as appropriate to the person's duties, upon hiring, and periodically thereafter, at least once annually. (b) All personnel (including temporary, part time, seasonal, and contracted personnel) who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must have a combination of education, training, and experience necessary to perform the person's assigned duties in a manner that ensures compliance with this part. (c) Training must be conducted in a manner that is easily understood by personnel being trained. (d) Training must be repeated as necessary and appropriate in light of observations or information indicating that personnel are not meeting standards established by FDA in subparts C through O of this part.

(a) If the owner, operator, or agent in charge of a farm appeals the order without requesting a hearing, the presiding officer must issue a written report that includes a final decision confirming or revoking the withdrawal by the 10th calendar day after the appeal is filed. (b) If the owner, operator, or agent in charge of a farm appeals the order and requests an informal hearing: (1) If FDA grants the request for a hearing and the hearing is held, the presiding officer must provide a 2 calendar day opportunity for the hearing participants to review and submit comments on the report of the hearing under § 112.208(c)(4), and must issue a final decision within 10 calendar days after the hearing is held; or (2) If FDA denies the request for a hearing, the presiding officer must issue a final decision on the appeal confirming or revoking the withdrawal within 10 calendar days after the date the appeal is filed.

An order to withdraw a qualified exemption applicable to a farm under § 112.5 is revoked if: (a) The owner, operator, or agent in charge of the farm appeals the order and requests an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10 calendar days after the hearing, or issues a decision revoking the order within that time; or (b) The owner, operator, or agent in charge of the farm appeals the order and requests an informal hearing, FDA denies the request for an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time; or (c) The owner, operator, or agent in charge of the farm appeals the order without requesting an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time. (d) Confirmation of a withdrawal order by the presiding officer is considered a final Agency action for purposes of 5 U.S.C. 702.

(a) If the FDA Division Director in whose division your 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) determines that the farm has adequately resolved any problems with the conduct and conditions that are material to the safety of the food produced or harvested at such farm, and that continued withdrawal of the exemption is not necessary to protect the public health or prevent or mitigate a foodborne illness outbreak, the FDA Division Director in whose division your 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) will, on his or her own initiative or at the request of a farm, reinstate the qualified exemption. (b) You may ask FDA to reinstate a qualified exemption that has been withdrawn under the procedures of this subpart as follows: (1) Submit a request, in writing, to the FDA Division Director in whose division your 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); and (2) Present, in…

(a) At a minimum, all personnel who handle (contact) covered produce during covered activities or supervise the conduct of such activities must receive training that includes all of the following: (1) Principles of food hygiene and food safety; (2) The importance of health and personal hygiene for all personnel and visitors, including recognizing symptoms of a health condition that is reasonably likely to result in contamination of covered produce or food contact surfaces with microorganisms of public health significance; and (3) The standards established by FDA in subparts C through O of this part that are applicable to the employee's job responsibilities. (b) Persons who conduct harvest activities for covered produce must also receive training that includes all of the following: (1) Recognizing covered produce that must not be harvested, including covered produce that may be contaminated with known or reasonably foreseeable hazards; (2) Inspecting harvest containers and equipment to ensure that they are functioning properly, clean, and maintained so as not to become a source of contamination of covered produce with known or reasonably foreseeable hazards; and (3)…

You must assign or identify personnel to supervise (or otherwise be responsible for) your operations to ensure compliance with the requirements of this part.

The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply: Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice. Adequately reduce microorganisms of public health significance means reduce the presence of such microorganisms to an extent sufficient to prevent illness. Agricultural tea means a water extract of biological materials (such as stabilized compost, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, table waste, or yard trimmings), excluding any form of human waste, produced to transfer microbial biomass, fine particulate organic matter, and soluble chemical components into an aqueous phase. Agricultural teas are held for longer than one hour before application. Agricultural teas are soil amendments for the purposes of this rule. Agricultural tea additive means a nutrient source (such as molasses, yeast extract, or algal powder) added to agricultural tea to increase microbial biomass. Agricultural water means water used in covered activities on covered…

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part. (b) You must establish and keep records of training that document required training of personnel, including the date of training, topics covered, and the persons(s) trained.

(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). (b) The measures you must take to satisfy the requirements of paragraph (a) of this section must include all of the following measures: (1) Excluding any person from working in any operations that may result in contamination of covered produce or food contact surfaces with microorganisms of public health significance when the person (by medical examination, the person's acknowledgement, or observation) is shown to have, or appears to have, an applicable health condition, until the person's health condition no longer presents a risk to public health; and (2) Instructing personnel to notify their supervisor(s) (or a responsible party) if they have, or if there is a reasonable possibility that they have an applicable health condition.

(a) Personnel who work in an operation in which covered produce or food contact surfaces are at risk of contamination with known or reasonably foreseeable hazards must use hygienic practices while on duty to the extent necessary to protect against such contamination. (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: (i) Before…

(a) You must make visitors aware of policies and procedures to protect covered produce and food contact surfaces from contamination by people and take all steps reasonably necessary to ensure that visitors comply with such policies and procedures. (b) You must make toilet and hand-washing facilities accessible to visitors.

(a) Except as provided in paragraph (b) of this section, a farm or farm mixed-type facility with an average annual monetary value of produce (as “produce” is defined in § 112.3) sold during the previous 3-year period of more than $25,000 (on a rolling basis), adjusted for inflation using 2011 as the baseline year for calculating the adjustment, is a “covered farm” subject to this part. Covered farms subject to this part must comply with all applicable requirements of this part when conducting a covered activity on covered produce. (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. [80 FR 74547, Nov. 27, 2015, as amended at 84 FR 12490, Apr. 2, 2019]

All agricultural water must be safe and of adequate sanitary quality for its intended use.

(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; (4) Use of adjacent and nearby land; and (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. (b) You must adequately maintain all agricultural water distribution systems to the extent they are under your control as necessary and appropriate to prevent the water distribution system from being a source of…

(a) When agricultural water is treated in accordance with § 112.45: (1) Any method you use to treat agricultural water (such as with physical treatment, including using a pesticide device as defined by the U.S. Environmental Protection Agency (EPA); EPA-registered antimicrobial pesticide product; or other suitable method) must be effective to make the water safe and of adequate sanitary quality for its intended use and/or meet the relevant microbial quality criteria in § 112.44, as applicable. (2) You must deliver any treatment of agricultural water in a manner to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use and/or consistently meets the relevant microbial quality criteria in § 112.44, as applicable. (b) You must monitor any treatment of agricultural water at a frequency adequate to ensure that the treated water is consistently safe and of adequate sanitary quality for its intended use and/or consistently meets the relevant microbial quality criteria in § 112.44, as applicable.

Escherichia coliE. coli(a) When you use agricultural water for any one or more of these following purposes, you must ensure there is no detectable generic () in 100 milliliters (mL) of agricultural water, and you must not use untreated surface water for any of these purposes: (1) Used as sprout irrigation water; (2) Applied in any manner that directly contacts covered produce during or after harvest activities (for example, water that is applied to covered produce for washing or cooling activities, and water that is applied to harvested crops to prevent dehydration before cooling), including when used to make ice that directly contacts covered produce during or after harvest activities; (3) Used to contact food contact surfaces, or to make ice that will contact food contact surfaces; and (4) Used for washing hands during and after harvest activities. (b) When you use agricultural water during growing activities for covered produce (other than sprouts) using a direct water application method, the following criteria apply (unless you establish and use alternative criteria in accordance with § 112.49): E. coli(1) A geometric mean (GM) of your agricultural water samples of 126…

(a) If you have determined or have reason to believe that your agricultural water is not safe or of adequate sanitary quality for its intended use as required under § 112.41 and/or if your agricultural water does not meet the microbial quality criterion for the specified purposes as required under § 112.44(a), you must immediately discontinue that use(s), and before you may use the water source and/or distribution system again for the intended use(s), you must either: (1) Re-inspect the entire affected agricultural water system to the extent it is under your control, identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces, make necessary changes, and take adequate measures to determine if your changes were effective and, as applicable, adequately ensure that your agricultural water meets the microbial quality criterion in § 112.44(a); or (2) Treat the water in accordance with the requirements of § 112.43. (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…

(a) There is no requirement to test any agricultural water that is subject to the requirements of § 112.44 when: (1) You receive water from a Public Water System, as defined under the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that furnishes water that meets the microbial requirements under those regulations or under the regulations of a State (as defined in 40 CFR 141.2) approved to administer the SDWA public water supply program, and you have Public Water System results or certificates of compliance that demonstrate that the water meets that requirement; (2) You receive water from a public water supply that furnishes water that meets the microbial quality requirement described in § 112.44(a), and you have public water system results or certificates of compliance that demonstrate that the water meets that requirement; or (3) You treat water in accordance with the requirements of § 112.43. (b) Except as provided in paragraph (a) of this section, you must take the following steps for each source of water used for purposes that are subject to the requirements of § 112.44(b): (1) Conduct an initial survey to develop a microbial water quality profile of the…

(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 (2) Data collected by a third party or parties, provided the water source(s) sampled by the third party or parties adequately represent your agricultural water source(s) and all other applicable requirements of this part are met. (b) Agricultural water samples must be aseptically collected and tested using a method as set forth in § 112.151.

(a) You must manage the water as necessary, including by establishing and following water-change schedules for re-circulated water, to maintain its safety and adequate sanitary quality and minimize the potential for contamination of covered produce and food contact surfaces with known or reasonably foreseeable hazards (for example, hazards that may be introduced into the water from soil adhering to the covered produce). (b) You must visually monitor the quality of water that you use during harvest, packing, and holding activities for covered produce (for example, water used for washing covered produce in dump tanks, flumes, or wash tanks, and water used for cooling covered produce in hydrocoolers) for buildup of organic material (such as soil and plant debris). (c) You must maintain and monitor the temperature of water at a temperature that is appropriate for the commodity and operation (considering the time and depth of submersion) and is adequate to minimize the potential for infiltration of microorganisms of public health significance into covered produce.

Provided you satisfy the requirements of § 112.12, you may establish and use one or more of the following alternatives: (a) An alternative microbial quality criterion (or criteria) using an appropriate indicator of fecal contamination, in lieu of the microbial quality criteria in § 112.44(b); (b) An alternative microbial die-off rate and an accompanying maximum time interval, in lieu of the microbial die-off rate and maximum time interval in § 112.45(b)(1)(i); (c) An alternative minimum number of samples used in the initial survey for an untreated surface water source, in lieu of the minimum number of samples required under § 112.46(b)(1)(i)(A); and (d) An alternative minimum number of samples used in the annual survey for an untreated surface water source, in lieu of the minimum number of samples required under § 112.46(b)(2)(i)(A).

(a) A farm is eligible for a qualified exemption and associated modified requirements in a calendar year if: (1) During the previous 3-year period preceding the applicable calendar year, the average annual monetary value of the food (as defined in § 112.3) the farm sold directly to qualified end-users (as defined in § 112.3) during such period exceeded the average annual monetary value of the food the farm sold to all other buyers during that period; and (2) The average annual monetary value of all food (as defined in § 112.3) the farm sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation. (b) For the purpose of determining whether the average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation, the baseline year for calculating the adjustment for inflation is 2011. [80 FR 74547, Nov. 27, 2015, as amended at 84 FR 12490, Apr. 2, 2019]

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part. (b) You must establish and keep the following records: (1) The findings of the inspection of your agricultural water system in accordance with the requirements of § 112.42(a); (2) Documentation of the results of all analytical tests conducted on agricultural water for purposes of compliance with this subpart; (3) Scientific data or information you rely on to support the adequacy of a method used to satisfy the requirements of § 112.43(a)(1) and (2); (4) Documentation of the results of water treatment monitoring under § 112.43(b); Escherichia coliE. coli(5) Scientific data or information you rely on to support the microbial die-off or removal rate(s) that you used to determine the time interval (in days) between harvest and end of storage, including other activities such as commercial washing, as applicable, used to achieve the calculated log reduction of generic (), in accordance with § 112.45(b)(1)(ii); (6) Documentation of actions you take in accordance with § 112.45. With respect to any time interval or (calculated) log reduction applied in…

Escherichia coliE. coli(a) A biological soil amendment of animal origin is treated if it has been processed to completion to adequately reduce microorganisms of public health significance in accordance with the requirements of § 112.54, or, in the case of an agricultural tea, the biological materials of animal origin used to make the tea have been so processed, the water used to make the tea is not untreated surface water, and the water used to make the tea has no detectable generic () in 100 milliliters (mL) of water. (b) A biological soil amendment of animal origin is untreated if it: E. coli(1) Has not been processed to completion in accordance with the requirements of § 112.54, or in the case of an agricultural tea, the biological materials of animal origin used to make the tea have not been so processed, or the water used to make the tea is untreated surface water, or the water used to make the tea has detectable generic in 100 mL of water; (2) Has become contaminated after treatment; (3) Has been recombined with an untreated biological soil amendment of animal origin; (4) Is or contains a component that is untreated waste that you know or have reason to believe is…

(a) You must handle, convey and store any biological soil amendment of animal origin in a manner and location such that it does not become a potential source of contamination to covered produce, food contact surfaces, areas used for a covered activity, water sources, water distribution systems, and other soil amendments. Agricultural teas that are biological soil amendments of animal origin may be used in water distribution systems provided that all other requirements of this rule are met. (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. (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.

You may not use human waste for growing covered produce, except sewage sludge biosolids used in accordance with the requirements of 40 CFR part 503, subpart D, or equivalent regulatory requirements.

Each of the following treatment processes are acceptable for a biological soil amendment of animal origin that you apply in the growing of covered produce, provided that the resulting biological soil amendments are applied in accordance with the applicable requirements of § 112.56: e.g.,e.g.,e.g.,Listeria monocytogenesL. monocytogenesSalmonellaE. coli(a) A scientifically valid controlled physical process ( thermal), chemical process ( high alkaline pH), biological process ( composting), or a combination of scientifically valid controlled physical, chemical and/or biological processes that has been validated to satisfy the microbial standard in § 112.55(a) for (), species, and O157:H7; or Salmonellae.g.,(b) A scientifically valid controlled physical, chemical, or biological process, or a combination of scientifically valid controlled physical, chemical, and/or biological processes, that has been validated to satisfy the microbial standard in § 112.55(b) for species and fecal coliforms. Examples of scientifically valid controlled biological ( composting) processes that meet the microbial standard in § 112.55(b) include: i.e.,(1) Static composting that maintains aerobic (…

The following microbial standards apply to the treatment processes in § 112.54 as set forth in that section. L. monocytogenes,SalmonellaE. coli(a) For species, and O157:H7, the relevant standards in the table in this paragraph (a); or SalmonellaSalmonella(b) species are not detected using a method that can detect three MPN species per 4 grams (or milliliter, if liquid is being sampled) of total solids; and less than 1,000 MPN fecal coliforms per gram (or milliliter, if liquid is being sampled) of total solids. Table | For the microorganism— | The microbial standard is— | | --- | --- | | L. monocytogenes03(1) | Not detected using a method that can detect one colony forming unit (CFU) per 5 gram (or milliliter, if liquid is being sampled) analytical portion. | | Salmonella03(2) species | Not detected using a method that can detect three most probable numbers (MPN) per 4 grams (or milliliter, if liquid is being sampled) of total solids. | | E. coli03(3) O157: H7 | Not detected using a method that can detect 0.3 MPN per 1 gram (or milliliter, if liquid is being sampled) analytical portion. | [80 FR 74547, Nov. 27, 2015, as amended at 81 FR 26468, May 3, 2016]

(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). (b) [Reserved] Table | If the biological soil amendment of animal origin is— | Then the biological soil amendment of animal origin must be applied— | And then theminimum application interval is— | | --- | --- | --- | | (1)(i) Untreated | In a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application | [Reserved]. | | (ii) Untreated | In a manner that does not contact covered produce during or after application | 0 days. | | (2) Treated by a scientifically valid controlled physical, chemical, or biological process, or combination of scientifically valid controlled physical, chemical, and/or biological processes, in accordance with the requirements of § 112.54(b) to meet the microbial standard in § 112.55(b) | In a manner that minimizes the potential for…

(a) If your farm is eligible for a qualified exemption in accordance with § 112.5, you are subject to the requirements of: (1) This subpart (General Provisions); (2) Subpart O of this part (Records); (3) Subpart Q of this part (Compliance and Enforcement); and (4) Subpart R of this part (Withdrawal of Qualified Exemption). (b) In addition, you are subject to the following modified requirements: (1) When a food packaging label is required on food that would otherwise be covered produce under the Federal Food, Drug, and Cosmetic Act or its implementing regulations, you must include prominently and conspicuously on the food packaging label the name and the complete business address of the farm where the produce was grown. (2) When a food packaging label is not required on food that would otherwise be covered produce under the Federal Food, Drug, and Cosmetic Act, you must prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the produce in the normal course of business, or, in the case of Internet sales, in…

(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part. (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 (2) For a treated biological soil amendment of animal origin you produce for your own covered farm(s), documentation that process controls (for example, time, temperature, and turnings) were achieved.

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. Such receipts must be dated as required under § 112.161(a)(4). (b) You must establish and keep adequate records necessary to demonstrate that your farm satisfies the criteria for a qualified exemption that are described in § 112.5, including a written record reflecting that you have performed an annual review and verification of your farm's continued eligibility for the qualified exemption.

(a) The requirements of this subpart apply when a covered activity takes place in an outdoor area or a partially-enclosed building and when, under the circumstances, there is a reasonable probability that animals will contaminate covered produce. (b) The requirements of this subpart do not apply: (1) When a covered activity takes place in a fully-enclosed building; or (2) To fish used in aquaculture operations.

(a) You must take the steps set forth in paragraph (b) of this section if under the circumstances there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce. (b) You must: (1) Assess the relevant areas used for a covered activity for evidence of potential contamination of covered produce as needed during the growing season (based on your covered produce; your practices and conditions; and your observations and experience); and (2) If significant evidence of potential contamination is found (such as observation of animals, animal excreta or crop destruction), you must evaluate whether the covered produce can be harvested in accordance with the requirements of § 112.112 and take measures reasonably necessary during growing to assist you later during harvest when you must identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard.

i.e.,No. Nothing in this regulation authorizes the “taking” of threatened or endangered species as that term is defined by the Endangered Species Act (16 U.S.C. 1531-1544) ( to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct), in violation of the Endangered Species Act. This regulation does not require covered farms 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.