21 cfr 112
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 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. 264). Agricultural water means water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces, including water used in growing activities (including irrigation water applied using direct water application methods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or cooling harvested produce and water used for preventing dehydration of covered produce). Sec. 112.202 What procedure will FDA use to withdraw an exemption? Sec. (b) You must establish and keep documentation of the date and method of cleaning and sanitizing of equipment subject to this subpart used in: (2) Covered harvesting, packing, or holding activities. 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. Sec. All of the following testing requirements apply for the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes. 112.111 What measures must I take if I grow, harvest, pack or hold both covered and excluded produce? 21 CFR 117 deals with risk management issues around food. Title 21 - Food and Drugs last revised: Nov 16, 2020 All Titles Title 21 Chapter I Part 112 Subpart A - General Provisions View all text of Subpart A [§ 112.1 - § 112.7] (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) At least one supervisor or responsible party for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration. The term "farm" includes operations that, in addition to these activities: (i) Pack or hold raw agricultural commodities; (ii) Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in paragraph (1)(iii)(B)(1 ) of this definition; and. Produce means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. (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. Biological soil amendment of animal origin means a biological soil amendment which consists, in whole or in part, of materials of animal origin, such as manure or non-fecal animal byproducts including animal mortalities, or table waste, alone or in combination. 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: (a) A scientifically valid controlled physical process (e.g., thermal), chemical process (e.g., high alkaline pH), biological process (e.g., 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 Listeria monocytogenes (L. monocytogenes ), Salmonella species, and E. coli O157:H7; or. 21 CFR Part 111_Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. (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 agricultural water source. Sec. Subpart K - Growing, Harvesting, Packing, and Holding Activities. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html ; or. (iii) Manufacture/process food, provided that: (A) All food used in such activities is consumed on that farm or another farm under the same management; or. § 112.205 - Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm? (9) Any analytical methods you use in lieu of the method that is incorporated by reference in § 112.151(a). Sec. Records obtained by FDA in accordance with this part are subject to the disclosure requirements under part 20 of this chapter. The auditor must be sure to evaluate both where necessary. 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. 112.45 What measures must I take if my agricultural water does not meet the requirements of 112.41 or 112.44? 112.113 How must I handle harvested covered produce during covered activities? § 112.21 - What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces? § 112.125 - What requirements apply to equipment that is subject to this subpart used in the transport of covered produce? 552(a) and 1 CFR part 5. (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. (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. § 112.45 - What measures must I take if my agricultural water does not meet the requirements of 112.41 or 112.44? 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen? [80 FR 74547, Nov. 27, 2015, as amended at 85 FR 16552, Mar. 112.2 What produce is not covered by this part? Sec. Monitor means to conduct a planned sequence of observations or measurements to assess whether a process, point or procedure is under control and, when required, to produce an accurate record of the observation or measurement. Relevant Statutory Authorities Other Than Section 419 of the FD&C Act and Section 105 of FSMA B. 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. (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. (4) Subpart R of this part (Withdrawal of Qualified Exemption). With respect to any time interval or (calculated) log reduction applied in accordance with § 112.45(b)(1)(i) and/or (ii), such documentation must include the specific time interval or log reduction applied, how the time interval or log reduction was determined, and the dates of corresponding activities such as the dates of last irrigation and harvest, the dates of harvest and end of storage, and/or the dates of activities such as commercial washing); (7) Annual documentation of the results or certificates of compliance from a public water system required under § 112.46(a)(1) or (2), if applicable; (8) Scientific data or information you rely on to support any alternative that you establish and use in accordance with § 112.49; and.
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