Agricultural Law in the Spotlight—FSMA Regulatory Update

Written by Errin McCaulley – Research Assistant

On January 19, 2017 the Food and Drug Administration (FDA) announced the issuance of draft guidance titled Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations (FDA-2017-D-0175). Specifically, FDA has published this draft guidance to aid sprout operations comply with Subpart M (21 C.F.R. §§ 112.141-112.150) of the Produce Safety Rule. Interested parties wishing to comment upon this draft guidance may do so through https://www.regulations.gov/. Alternatively, written comments should be submitted to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should include reference to docket number FDA-2017-D-0175.

Scope of Draft Guidance

Generally, Subpart M applies to operations engaged in the “growing, harvesting, packing and holding of all sprouts,” as those terms are defined in the Rule, not otherwise exempted from coverage. Subpart M does not, however, apply to sprouts that are grown in soil or non-soil substrates which are harvested above the soil or substrate line without roots. This draft guidance does not cover all other applicable requirements for sprout operations under the Produce Safety Rule, such as Subpart F (relating to biological soil amendments), but does include reference to key provisions which are supplemented by Subpart M. For example, Subpart M includes sprout-specific building, tools, and equipment standards (21 C.F.R. § 112.143(a)-(b)) that apply in addition to Subpart L’s buildings, tools, and equipment standards (21 C.F.R. § 112.122). The majority of this draft guidance is devoted to the various testing requirements under Subpart M relating to E. coli, Salmonella, Listeria, and L. monocytogenes. Lastly, this draft guidance includes advice regarding voluntary compliance with Subpart M for sprout operations that are otherwise exempted from coverage under the Produce Safety Rule.