Jan 23, 2017

FDA issues draft guidance for sprout operations

The U.S. Food and Drug Administration (FDA) has issued draft guidance to assist sprout operations subject to the Produce Safety Rule (80 FR 74353), and primarily focuses on assisting such operations in complying with the sprout-specific requirements in Subpart M. Comments on the draft guidance will be accepted through July 24.

It provides this assistance in part by describing voluntary practices, including some practices that can help operations avoid problems under these requirements. It also includes limited discussion on certain other applicable requirements. In addition, this guidance may also be useful to sprout operations that are not subject to the Produce Safety Rule that voluntarily choose to follow the standards established in the rule, according to FDA.

Because of the diversity of sprout production practices and types of sprouts, the recommendations in this guidance will be most effective when you adapt these recommendations to the specific practices, processes and procedures at your operation.

It does not describe all aspects of all requirements of the Produce Safety Rule, but rather highlights certain sprout-specific requirements (Subpart M), and briefly discusses certain other rule requirements from the perspective of a sprout operation (e.g., certain requirements in Subparts E and L of the rule relating to Agricultural Water, and Equipment, Tools, Buildings, and Sanitation, respectively).

Comments may be submitted in writing or online.

Submit Written Comments
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852

Submit Comments Online
Submit electronic comments on http://www.regulations.gov to docket folder FDA-2017-D-0175.