The Food and Drug Administration is conducting a risk assessment that will evaluate and, if feasible, quantify the risk of human illness associated with consumption of produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin that are potentially contaminated with enteric pathogens, such as Escherichia coli O157:H7 or Salmonella. The risk assessment also will evaluate the impact of certain interventions, such as use of a time interval between application of the soil amendment and crop harvest, on the predicted risk. The risk assessment is intended to inform policy decisions with regard to produce safety.
FDA is requesting scientific data, information, and comments that would assist the Agency in its plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure).
Submissions can be made electronically to Docket No. FDA-2016-N-0321 starting March 4, 2016.
FDA extended the comment period close date to July 19, 2016. Learn more about the extension of the comment period.
- Raw Manure under the FSMA Final Rule on Produce Safety
- Fact Sheet: Biological Soil Amendments of Animal Origin (PDF: 132KB)
- Fact Sheet: Biological Soil Amendments of Animal Origin (Spanish) (PDF: 169KB)