IMPORTANT: This text was last updated in November 2013. It does not reflect changes made to the proposed FSMA rules in 2014. We will update this header when the text has been updated to reflect the re-proposed rules!
Farmers use soil amendments such as manure and compost to improve soil fertility and soil quality, and to enhance populations of beneficial microorganisms in the soil. Sustainable and organic producers in particular rely on manure and compost instead of synthetic chemicals to add fertility to their fields.
The Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (FDA) to develop regulations aimed at improving the safety of produce. Soil amendments such as manure have been identified as a potential vector for pathogens that may contaminate produce, and Congress required FDA to include standards for “soil amendments” when developing new regulations. In the proposed Produce Rule, FDA has developed standards directed to “biological soil amendments of animal origin” – e.g., manure and compost that includes animal waste and human waste.
In addition to requiring standards on soil amendments, Congress also specified that FDA could not propose requirements that conflict with or duplicate the requirements for certified organic production. Manure and compost are critical soil amendments in certified organic production and in sustainable farming systems, and it is important that new standards work for these types of systems. Congress also required FDA to take into consideration conservation and environmental practice standards such as those by USDA’s Natural Resources Conservation Service, which offers assistance with nutrient management and composting facilities, among other things.
The requirements only apply to biological soil amendments of animal origin – including manure, bloodmeal, and fish emulsion – and human waste. They also address agricultural tea (“compost tea”). They do no apply to non-biological soil amendments (e.g., physical or chemical) and they do not apply to soil amendments of non-animal origin such as yard waste, purely vegetative matter, or shrub trimmings.
Broadly, the proposed standards seek to avoid contamination of “covered” produce (click here for the list of produce subject to the requirements of the Produce Rule) by pathogens potentially present in biological soil amendments of animal origin. Generally, the proposed standards set treatment requirements for soil amendments and minimum intervals between application and harvest.
The interval between application of a biological soil amendment of animal origin and harvest of covered produce is dependent on whether that amendment has been treated and, if yes, how it was treated.
The following intervals between application and harvest apply, depending on the type of treatment that the biological soil amendment of animal origin has undergone:
The 45-day interval is in conflict with the National Organic Program (NOP) regulations, which do not require an interval between application and harvest for manure treated by a composting process that is consistent with NOP composting standards.
For situations that would require the 45-day interval, FDA will accept “alternative” methods if they are scientifically valid, controlled composting processes supported by adequate scientific information or data.
In the case of agricultural tea, the water used must meet the requirements of the water standards.
FDA considers a soil amendment to be untreated if it has not been processed by the treatments described above, has been contaminated after treatment, has been recombined with an untreated amendment, or is contaminated with a hazard. FDA considers agricultural tea to be untreated if it contains an agricultural tea additive.
FDA is proposing to require a nine-month interval between application and harvest if the soil amendment is untreated and there is chance that the amendment will come into contact with covered produce after application.
This nine-month interval is in direct conflict with the National Organic Program regulations, which require a three or four-month application interval for untreated manure depending on whether the edible portion of the crop comes into contact with the soil indirectly or directly, respectively. This proposed requirement and the 45-day interval in compost (see above) are also in direct conflict with FSMA, which requires standards not to conflict with NOP regulations. FDA will accept “alternative” methods to this interval requirement if they are scientifically valid, controlled composting processes supported by adequate scientific information or data.
If there is no chance that covered produce will come into contact with the soil amendment during and after application, then there is no interval.
FDA requires farmers to handle, convey, and store biological soil amendments of animal origin in a way that does not contaminate covered produce; food-contact surfaces; areas used for growing, harvesting, holding, and packing; and water sources and distribution systems. Farmers must also make sure that treated amendments are not contaminated by untreated or “in-process” amendments.
FDA does not allow the use of human waste for growing covered produce, except for sewage sludge biosolids that are used according to Environmental Protection Agency requirements.
To accompany these proposed standards, FDA lays out specific recordkeeping requirements. These include documentation of the application date of any untreated or composted biological soil amendment of animal origin (except when there is no chance that the covered produce will come into contact with the soil after application). For soil amendments treated by a third party, documentation is required that details certain requirements. For soil amendments that a farmer treats, documentation showing process controls is required. If a farmer is using alternative methods, documentation in the form of scientific data or information is required.
The proposed standards for biological soil amendments of animal origin do not apply to soil amendments of purely non-animal origin. Additionally, the requirements do not apply to physical or chemical soil amendments, such as synthetic fertilizers.
The preamble also clarifies that the microbial standards are not meant to be lot-by-lot testing requirements, and testing is not required to validate treatment processes.
These standards do not apply to animal feces deposited in a field by wild or domesticated animals. Separate standards apply in that instance.
If you use soil amendments such as manure or compost that uses animal waste, FDA needs to hear from you about how these proposed rules might impact your farm operation. FDA is requesting comment on the proposed standards, on additional specific issues, and on information to include in additional guidance documents.
Here are some questions to guide your comments on this part of the proposed Produce Rule:
In addition to comments on the proposed standards, the specific issues that FDA would like comment on in this part of the proposed regulations include:
Thanks to NSAC member organization Wild Farm Alliance for their assistance in developing this analysis!
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