USFDA issues RFC in FR re BSAAO for FSMA PR

Lauren Gwin, Center for Small Farms & Community Food Systems, Oregon State University
Publish Date: 
Spring 2016
VolNo: 
Vol. XI No. 2

Here’s the translation: The U.S. Food and Drug Administration has issued a Request for Comments in the Federal Register regarding Biological Soil Amendments of Animal Origin, for the Food Safety Modernization Act Produce Rule.

That is, manure. And in this case, untreated manure as it is used in the growing of produce that will be consumed raw.

Unless you have been hiding under a rock with your fingers in your ears for the last few years, you know that one of the big controversies in the first draft of the FSMA Produce Rule was that FDA was going to require a 9-month application-to-harvest interval for untreated BSAAO. This was far longer than the National Organic Program requirement of a 3 to 4 month interval (depending on the risk of soil contact), and had no clear scientific justification.

After hearing the arguments and the evidence, FDA eventually agreed about the lack of scientific data and decided not to pursue a 9-month application-to-harvest interval for untreated manure. Instead, the Agency said, it would leave a blank space in the final rule for an appropriate length interval, which it would determine through a comprehensive risk assessment.

The time for that risk assessment has arrived. On March 4, FDA published a Request for Comment in the Federal Register asking for “scientific data, information, and comments” to kick off what will be a multi-year process. This first step is for FDA to gather all available scientific research, including information regarding current on-farm practices.

There will be future opportunities to comment on the risk assessment itself as well as the proposed rule when it comes along.

Comments on this phase are due May 3. In the run-up to that, the National Sustainable Agriculture Coalition is leading an effort to gather all relevant scientific research as well as survey farmers about practices. We will keep you in that loop to make sure that the interests of Oregon’s organic and sustainable farmers are heard during this public process.

To read the whole thing (it’s not actually that long) and get instructions on how to submit comments, go here: https://www.federalregister.gov/ articles/2016/03/04/2016-04712/risk-assessment-offoodborne-illness-associated-with-pathogens-fromproduce-grown-in-fields-amended