Draft Guidance for Industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human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

Contains Nonbinding Recommendations
Draft - Not for Implementation

January 2017

Please Note: This guidance is being distributed for comment purposes only.

Draft Guidance


How to Comment
You may submit either electronic or written comments regarding this guidance through July 24, 2017.

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 to docket folder FDA-2017-D-0175.

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1700.

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.

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.


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