Draft Guidance for Industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations
- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Food Safety
This guidance is intended 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. 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.
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. This guidance focuses primarily on providing recommendations to assist sprout operations covered by Subpart M in complying with the requirements in the Produce Safety Rule applicable to sprouts. 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).
This guidance does not attempt to cover best practices or requirements outside the scope of the Produce Safety Rule. For example, the Produce Safety Rule does not address chemical or physical hazards. You have a responsibility to ensure that your sprouts are not adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. §§ 301 et seq.) and are in compliance with all applicable laws.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-0175.