FDA Releases Final Rule on Produce Safety Allowing for use of Biosolids

The provisions regarding biosolids are brief. It states: “You may not use human waste for growing covered produce, except sewage sludge biosolids used in accordance with the requirements of 40 CFR part 503, subpart D, or equivalent regulatory requirements.”

In response to comments over concerns regarding the use of biosolids even in compliance with Part 503 regulations, FDA responded with several positive statements regarding the Part 503 regulations. These include the following:

“In consultation with EPA, FDA has concluded that adherence to 40 CFR part 503 remains an appropriate approach to the use of biosolids for the growing of covered produce. We continue to believe that these requirements are appropriately protective of public health.”

“FDA, in consultation with EPA, has determined that 40 CFR part 503 remains the most appropriate approach to safe use of sewage sludge biosolids on land involved in the production of covered produce. We point out that the NAS 2002 report (Ref. 177) noted that there is “…no documented evidence to indicate that part 503 has failed to protect public health”; that EPA responded to the NAS review with a 14-point action plan, which it is carrying out; and that under section 405(d)(2)(C) of the CWA, EPA is required to publish a biennial review of part 503 (Ref. 178). FDA concludes that the provisions of 40 CFR part 503 are appropriate standards for protecting public health with respect to the use of sewage sludge biosolids in growing covered produce.”

The final rule is available here: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm