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| [Code of Federal Regulations] |
| [Title 21, Volume 2] |
| [CITE: 21CFR112] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
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| PART 112 | STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION |
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Subpart F - Biological Soil Amendments of Animal Origin and Human Waste
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Sec. 112.51 What requirements apply for determining the status of a biological soil amendment of animal origin?
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(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 Escherichia coli (E. coli ) in 100 milliliters (mL) of water.
(b) A biological soil amendment of animal origin is untreated if it:
(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 E. coli 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 contaminated with a hazard or has been associated with foodborne illness; or
(5) Is an agricultural tea made with biological materials of animal origin that contains an agricultural tea additive.
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Sec. 112.52 How must I handle, convey, and store biological soil amendments of animal origin?
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(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.
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Sec. 112.53 What prohibitions apply regarding use of human waste?
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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.
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Sec. 112.54 What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?
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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
(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 Salmonella species and fecal coliforms. Examples of scientifically valid controlled biological (e.g., composting) processes that meet the microbial standard in § 112.55(b) include:
(1) Static composting that maintains aerobic (i.e., oxygenated) conditions at a minimum of 131 deg.F (55 deg.C) for 3 consecutive days and is followed by adequate curing; and
(2) Turned composting that maintains aerobic conditions at a minimum of 131 deg.F (55 deg.C) for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is followed by adequate curing.
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Sec. 112.55 What microbial standards apply to the treatment processes in 112.54?
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The following microbial standards apply to the treatment processes in § 112.54 as set forth in that section.
(a) For L. monocytogenes, Salmonella species, and E. coli O157:H7, the relevant standards in the table in this paragraph (a); or
| For the microorganism -
| The microbial standard is -
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| (1) L. monocytogenes | 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.
| | (2) Salmonella 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.
| | (3) E. coli 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. |
(b) Salmonella species are not detected using a method that can detect three MPN Salmonella 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.
[80 FR 74547, Nov. 27, 2015, as amended at 81 FR 26468, May 3, 2016]
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Sec. 112.56 What application requirements and minimum application intervals apply to biological soil amendments of animal origin?
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(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).
| If the biological soil amendment of animal origin is -
| Then the biological soil amendment of animal origin must be applied -
| And then the
minimum application interval is -
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| (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 contact with covered produce during and after application | 0 days.
| | (3) Treated by a scientifically valid controlled physical, chemical, or biological process, or combination of scientifically valid controlled physical, chemical, or biological processes, in accordance with the requirements of § 112.54(a) to meet the microbial standard in § 112.55(a) | In any manner (i.e., no restrictions) | 0 days. |
(b) [Reserved]
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Sec. 112.60 Under this subpart, what requirements apply regarding records?
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(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.
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Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
Source: 80 FR 74547, Nov. 27, 2015, unless otherwise noted.
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