Archives for December 2021

The FDA recently released the long-anticipated proposed changes to the agricultural water requirements (Subpart E) of the Produce Safety Rule. On Thursday, December 16 at 3:00 pm ET, join United Fresh, PMA, Georgia Fruit and Vegetable Growers Association, Northwest Horticultural Council and Western Growers for a timely webinar covering what FDA has proposed and where FDA is seeking public comment (due April 5).

To learn more about the proposed changes and the process of public comment sign up for the webinar: Webinar Registration – Zoom

Subpart E of the Food Safety Modernization Act Produce Safety Rule has been under review for some time.  On December 6, 2021, FDA published in the Federal Register the proposed final rule.  There is a 120-day comment period which ends April 5, 2022.  Once the FDA reviews comments and publishes the final rule it will go into effect 60 days later.  The proposed rule applies to anyone who produces fresh fruits or vegetables and sales over $25,000 annually.

Federal Register:  https://www.federalregister.gov/documents/2021/12/06/2021-26127/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-relating.  The proposed rule is 35 pages – 69120 to 69155 (small print).  The actual proposed rule starts on page 69130.

The current agricultural water compliance dates are set to begin in January 2022, but

FDA intends to exercise enforcement discretion for the agricultural water requirements for covered produce (other than sprouts) while proposing to extend the compliance dates for ALL Subpart E provisions.  More information about the proposed compliance dates will be announced in the Federal Register and we will publicize those dates when announced.

FDA is looking for comments that are thoughtful and substantive, containing real life examples and solutions will assist them in creating a document that better suits the needs of fresh produce farmers across the country.

The On-Farm Food Safety Team has started to review the proposed rule.  We will be sending out more information with areas where you may want to comment in the next few weeks.

Following are the instructions for making comments:

Proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water: https://public-inspection.federalregister.gov/2021-26127.pdf

Submit electronic comments in the following way:

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.”)

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-2021-N-0471 for “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water.” 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 Dockets Management Staff between 9 a.m. and 4 p.m. Eastern Time, 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.” The Agency will review this copy, including the claimed confidential information, in its 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.