Requirements for Additional Traceability Records for Certain Foods Under the Food Safety Modernization Act (FSMA) Produce Rule

The Food and Drug Administration (FDA) is proposing a new rule on produce traceability under FSMA.  This new rule will impact most wholesale fruit and vegetable growers in New Jersey and some retail growers.  There is a 120-day (until January 21, 2021) comment period to respond to the proposed rule.  Take the time to review the rule and make comments!  Do not think it will not impact your operation it will.

What is in the Proposed Rule?

  • Those who manufacture, process, pack, or hold a food on the FOOD TRACEBILITY LIST would be required to establish and maintain records associated with specific Critical Tracking Events (CTEs), including growing, receiving, transforming, creating, and shipping.
  • For each CTE, entities would be required to establish and maintain records containing Key Data Elements (KDEs), such as the traceability lot code, the date the product was received, the date the product was shipped, and a product description.
  • In addition, those subject to the rule would also be required to create and maintain records related to their internal traceability program.
  • The proposed rule would require records to be maintained as either electronic, original paper records, or true copies.
  • In addition, the proposal states that in the event of a foodborne illness outbreak, a product recall, or other threat to public health, the FDA could require that firms submit, within 24 hours, an electronic sortable spreadsheet containing relevant traceability

There are some exemptions (full or partial).  Full exemptions include small retail food establishments, small farms (less than $25,000 in sales), farms selling food directly to consumers, certain food produced and packaged on a farm, food that receives certain types of processing and transporters of food.  Partial exemptions would apply to certain commingled raw agricultural commodities (not including fruits and vegetables subject to the produce safety regulations), fishing vessels, retail food establishments that receive a listed food directly from a farm and farm to school and farm to institutions programs.

How to Submit a Comment: 

Submit either electronic or written comments on the proposed rule by January 21, 2021.

The proposed rule was published in the Federal Register on September 23, 2020 (pages 59984-60038)

Electronic Submissions
Submit electronic comments in the following way:  Federal eRulemaking Portal: Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 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

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-2014-N-0053 for “Requirements for Additional Traceability Records for Certain Foods.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

Docket: For access to the docket to read background documents or the electronic and

written/paper comments received, go to 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.

Listening Sessions 

FDA will hold three virtual one-day public listening sessions to discuss the proposed rule and solicit public comments.  These meetings will occur on November 6 and 18 and December 2, 2020.  Search the FDA website for “FSMA Proposed Rule for Food Traceability” for the proposed rule and to sign up for one of the listening sessions.