How does the FDA plan to determine how much time should be required between the application of raw manure and the harvest of produce covered by the rule?

The FDA is deferring its decision on an appropriate time interval between the application of untreated biological soil amendments of animal origin, including manure, and harvest of covered produce until we pursue a risk assessment and research to supplement the science on an appropriate interval. We anticipate that these efforts will take five to 10 years to complete. Following the completion of the risk assessment and research work, we expect to:

1. provide stakeholders with data and information gathered from scientific investigations and risk assessment;
2. consider such new data and information to develop tentative scientific conclusions;
3. provide an opportunity for public comment on our tentative decisions; and
4. consider public input to finalize the provision(s) establishing an appropriate minimum application interval(s). The final produce rule contains other requirements related to the safe use of biological soil amendments of animal origin, including raw manure, in Subpart F.

For example, the rule establishes certain application method requirements for treated and untreated biological soil amendments of animal origin.