Updated: Nov 11, 2020
By Sarah Everhart
The article is not a substitute for legal advice. See here for the site’s reposting policy.
When we educate farmers on the Produce Safety Rule of the Food Safety Modernization Act (FSMA) an issue that never fails to spark questions is that of the use biological soil amendments of animal origin. By way of review, farmers who grown produce typically consumed raw and who have grossed more than $26,999 in the last three years (2015-2017) are subject to requirements of the Produce Safety Rule. The Produce Safety Rule impacts many aspects of farming, including but not limited to, the use of water (both before and after harvest), worker health and hygiene, and the use of biological soil amendments of animal origin (otherwise known as manure and compost). The law provides standards for the use of biological soil amendments of animal origin due to the potential risk of the produce being contaminated.
Given the questions we consistently are asked on this topic I was pleased when the U.S. Food and Drug Administration (FDA) (FSMA is a federal law but in Maryland it will be enforced by the Maryland Department of Agriculture) recently released a fact sheet on the use of manure and compost on produce. Unfortunately, despite the new fact sheet, there are still a lot of unanswered questions on the use of these soil amendments. At this point, this is what we know:
Definition of a Biological Soil Amendments
According to the Produce Safety Rule, biological soil amendment[s] of animal origin are biological soil amendments which consist, 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. Examples include: cattle manure; poultry litter; swine slurry; or horse manure. The term ‘‘biological soil amendment of animal origin’’ does not include any form of human waste. By contrast a biological soil amendment is any soil amendment containing biological materials such as stabilized compost, manure, non-fecal animal byproducts, peat moss, pre-consumer vegetative waste, sewage sludge biosolids, table waste, agricultural tea, or yard trimmings, alone or in combination.
A Treated Biological Soil Amendment of Animal Origin
A biological soil amendment of animal origin has been treated if it has been processed to completion to adequately reduce microorganisms. According to the law treated biological soil amendments of animal origin must be treated by either
(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 the law (21 C.F.R § 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 the law (21 C.F.R. § 112.55(b)) include:
(2) Turned composting that maintains aerobic conditions at a minimum of 131 °F (55 °C) for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is followed by adequate curing.
Using Untreated Biological Soil Amendments
The FDA is conducting a risk assessment and extensive research on the number of days needed between the applications of raw manure as a soil amendment and harvesting to minimize the risk of contamination. At this point, farmers are advised to follow the National Organic Program standards, which call for a 120 day interval between the application of raw manure for crops in contact with the soil and a 90 day interval for crops not in contact with the soil. Further, the Produce Safety Rule requires that untreated biological soil amendments of animal origin, such as raw manure, are applied in a manner that does not contact produce during application and minimizes the potential for contact with produce after application
Records to Keep
If you receive treated biological soil amendments of animal origin from a third party request and maintain documentation, at least annually, demonstrating that 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. If you create your own treated biological soil amendments of animal origin you are required to have documentation that process controls for the validated treatment process you use were achieved during treatment, such as time, temperature, and turnings. It is also required to, at least annually, to maintain documentation that biological soil amendments of animal origin have 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. Check out this past post on FSMA record keeping for more information and record forms.
Keep an eye on this blog and the food safety page of the ALEI website for future updates on these standards.