(3) The standards established by FDA in subparts C through O of this part that are applicable to the employee's job responsibilities. 1910.27 - Scaffolds and rope descent systems. 112.3 What definitions apply to this part? Ground water does not include any water that meets the definition of surface water. Sec. § 112.128 - What requirements apply regarding pest control in buildings? 112.210 What is the timeframe for issuing a decision on an appeal? Soil amendment means any chemical, biological, or physical material (such as elemental fertilizers, stabilized compost, manure, non-fecal animal byproducts, peat moss, perlite, pre-consumer vegetative waste, sewage sludge biosolids, table waste, agricultural tea and yard trimmings) intentionally added to the soil to improve the chemical or physical condition of soil in relation to plant growth or to improve the capacity of the soil to hold water. Sec. 112.115 What measures must I take when packaging covered produce? Sec. (a) At the beginning of a growing season, as appropriate, but at least once annually, you must inspect all of your agricultural water systems, to the extent they are under your control (including water sources, water distribution systems, facilities, and equipment), to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces in light of your covered produce, practices, and conditions, including consideration of the following: (1) The nature of each agricultural water source (for example, ground water or surface water); (2) The extent of your control over each agricultural water source; (3) The degree of protection of each agricultural water source; (5) The likelihood of introduction of known or reasonably foreseeable hazards to agricultural water by another user of agricultural water before the water reaches your covered farm. (c) In addition to E. coli O157:H7 and Salmonella 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 is reasonably necessary to minimize the risk of serious adverse health consequences or death from use of, or exposure to, sprouts; and. Sec. 112.131 What must I do to control and dispose of sewage? 112.161 What general requirements apply to records required under this part? 112.147 What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens? Instructions for Downloading Viewers and Players, STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION.    § 112.171 - Who may request a variance from the requirements of this part? Subpart C - Personnel Qualifications and Training. (a) Existing records (e.g., 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. (b) Adequate for use in transporting covered produce. (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. § 112.43 - What requirements apply to treating agricultural water? The effective date of the decision will be the date of publication of the notice. 112.56 What application requirements and minimum application intervals apply to biological soil amendments of animal origin? 112.55 What microbial standards apply to the treatment processes in 112.54? Curing means the final stage of composting, which is conducted after much of the readily metabolized biological material has been decomposed, at cooler temperatures than those in the thermophilic phase of composting, to further reduce pathogens, promote further decomposition of cellulose and lignin, and stabilize composition. 112.145 What requirements apply to testing the environment for Listeria species or L. monocytogenes? Sec. (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 contamination to covered produce, food contact surfaces, areas used for a covered activity, or water sources, including by regularly inspecting and adequately storing all equipment used in the system. 112.111 What measures must I take if I grow, harvest, pack or hold both covered and excluded produce? (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. (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. Document page views are updated periodically throughout the day and are cumulative counts for this document. 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) 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. 112.5 Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing? (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. Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Sanitize means to adequately treat cleaned surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. (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. * Indicates a term with a formal definition in 21 CFR 112.3(c) of the Produce Safety Rule 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. Sec.    § 112.41 - What requirements apply to the quality of agricultural water? (4) Used for washing hands during and after harvest activities. § 112.163 - May I use existing records to satisfy 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. Hazard means any biological agent that has the potential to cause illness or injury in the absence of its control. (iii) You must update the microbial water quality profile annually as required under paragraph (b)(2) of this section, and otherwise required under paragraph (b)(3) of this section. § 112.140 - Under this subpart, what requirements apply regarding records? § 112.177 - Can an approved variance apply to any person other than those identified in the petition requesting that variance? 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available? (2) Secondary activities farm. 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, (2) A scientifically valid method that is at least equivalent to the method of analysis in § 112.153(a)(1) in accuracy, precision, and sensitivity; and. 112.2 Definitions. Direct water application method means using agricultural water in a manner whereby the water is intended to, or is likely to, contact covered produce or food contact surfaces during use of the water. The information on this page is current as of April 1 2020. 21 CFR Part 111_Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. (vi) At any other time when the hands may have become contaminated in a manner that is reasonably likely to lead to contamination of covered produce with known or reasonably foreseeable hazards; (4) If you choose to use gloves in handling covered produce or food contact surfaces, maintaining gloves in an intact and sanitary condition and replacing such gloves when no longer able to do so; (5) Removing or covering hand jewelry that cannot be adequately cleaned and sanitized during periods in which covered produce is manipulated by hand; and. 112.213 If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption. Electronic Code of Federal Regulations (eCFR). (c) If you use untreated ground water for the purposes that are subject to the requirements of § 112.44(a), you must initially test the microbial quality of each source of the untreated ground water at least four times during the growing season or over a period of 1 year, using a minimum total of four samples collected to be representative of the intended use(s). (c) We will provide notice of our final decision as follows: (1) On the basis of the administrative record, FDA will issue a written decision, as provided for under part 16 of this chapter. (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. 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. 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 E. coli O157:H7, Salmonella species, and, if applicable, a pathogen meeting the criteria in § 112.144(c). 112.22 What minimum requirements apply for training personnel who conduct a covered activity? Composting means a process to produce stabilized compost in which organic material is decomposed by the actions of microorganisms under thermophilic conditions for a designated period of time (for example, 3 days) at a designated temperature (for example, 131 deg.F (55 deg.C)), followed by a curing stage under cooler conditions. Records I keep records required under this subpart used in the growing, harvesting packing. Or electric hand dryers ) applies to a petition are publicly available 112.47 who must perform tests! Final Agency action for purposes of 5 U.S.C and water Instructions for Downloading and. '' does not apply to the requirements of § 112.43, litter, and liquid storage tanks may. Activity documented What are the provisions for coordination of education and enforcement § 112.192 - What must... Wells, or at the hearing 112.193 What are the provisions for coordination of education and enforcement § -... 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