2023-21294. Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption; and Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of availability.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing the availability of two guidance documents that will help sprout operations subject to FDA's final rule entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (the Produce Safety Rule) understand the topics covered in the Produce Safety Rule pertaining to personnel qualifications, training, and hygienic practices; equipment, tools, and buildings; and sampling and testing of spent sprout irrigation water (or in-process sprouts). FDA is issuing a draft guidance entitled, “Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption,” which revises a currently issued draft guidance entitled “Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations” (January 23, 2017) (the January 2017 draft guidance). In addition, FDA is announcing the availability of a final guidance entitled “Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption,” which finalizes portions of the January 2017 draft guidance with additional clarifications in response to comments.

DATES:

Submit either electronic or written comments on the draft revised guidance by March 27, 2024 to ensure that FDA considers your comment on the draft revised guidance before we begin work on the final version of the guidance.

ADDRESSES:

You may submit comments on any guidance at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal:https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA–2017–D–0175 for “Draft Guidance for Industry: Standards for the Growing Harvesting, Packing, and Holding of Sprouts for Human Consumption.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the revised draft guidance document to the Division of Produce Safety, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1600. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Samir Assar, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740–3835, 240–402–1636.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a draft guidance for industry entitled “Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption.” The draft guidance is a revision of the January 2017 draft guidance entitled “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” and contains revised information in the sections entitled “Equipment, Tools and Buildings” (titled “Buildings, Tools and Equipment” in the January 2017 draft guidance) and “Sampling and Testing of Spent Sprout Irrigation Water (or In-Process sprouts)” (sections IV and V, respectively, which were sections IV and VIII in the January 2017 draft guidance) and consolidates information on personnel qualifications, training, and hygienic practices into a new standalone section. FDA is also issuing a final guidance entitled “Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption,” that finalizes recommendations from the January 2017 draft guidance with additional clarifications in response to comments. Additionally, we have revised the titles of both the draft guidance and final guidance to make them more concise and to promote clarity.

We are issuing these guidance documents consistent with our good guidance practices regulation (21 CFR 10.115). The guidance documents do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

In the Federal Register of January 23, 2017 (82 FR 7751), we made available the 2017 draft guidance and gave interested parties an opportunity to submit comments by July 24, 2017, for us to consider before beginning work on the final version of the guidance. We received several comments on the January 2017 draft guidance, and we address those comments in the final guidance.

We are issuing revised sections of the January 2017 draft guidance for additional comment in the draft guidance. The draft guidance includes revised sections on “Equipment, Tools and Buildings,” and “Sampling and Testing of Spent Sprout Irrigation Water (or In-Process Sprouts)”, and a new section entitled “Personnel Qualifications, Training, and Hygienic Practices.” We are issuing these sections for additional comment for the following reasons:

• Equipment, Tools and Buildings: This section has been revised to facilitate alignment with the recommendations in related guidances.

• Sampling and Testing of Spent Sprout Irrigation Water (or In-Process Sprouts): We are reissuing this section in draft to receive additional comments and feedback from sprouting operations, which will inform ongoing FDA research on this topic.
• Personnel Qualifications, Training, and Hygienic Practices: In the January 2017 draft guidance, many of the recommendations for personnel qualifications, training, and hygienic practices were dispersed throughout, rather than being consolidated in a single section. In the draft guidance, the recommendations are consolidated into a standalone section entitled “Personnel Qualifications, Training, and Hygienic Practices” to ensure that we present the recommendations comprehensively and to facilitate ease of reading.

We welcome comments on any aspect of the draft guidance. We are particularly interested in receiving information about any testing of spent sprout irrigation water or in-process sprouts that sprout operations are currently doing for non-O157 Shiga toxin-producing Escherichia coli (STEC), including test kit names (as applicable).

We are finalizing other sections of the January 2017 draft guidance with minor revisions. Changes to the final guidance include: clarifying the recommendations regarding the frequency of cleaning and sanitizing; providing additional recommendations on seed for sprouting, including seed treatment and corrective actions; removing language on voluntary periodic sampling and testing of sprouts, and clarifying our expectations for corrective actions after an operation detects Listeria spp. or Listeria monocytogenes in an environmental sample. We also received general comments that requested we shorten and simplify the guidance. As a result, we removed section III (“General Sprout Production,” as it appeared in the January 2017 draft guidance) because most of the language in this section was repeated elsewhere. We also made editorial changes to improve clarity and removed certain recommendations based on impracticality. The final guidance consists of the following sections:

• Cleaning and Sanitizing;
• Agricultural Water in Sprouting Operations;
• Seeds for Sprouting;
• Environmental Monitoring; and
• Recordkeeping.

II. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 112 have been approved under OMB control number 0910–0816.

III. Electronic Access

Persons with access to the internet may obtain the guidances at https://www.fda.gov/​food/​guidance-regulation-food-and-dietary-supplements/​guidance-documents-regulatory-information-topic-food-and-dietary-supplements, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

Dated: September 21, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.