Kathy Wybourn, DNV-GL

Ask the Expert: Track and Trace–FDA FSMA Proposed Rule for Food Traceability

Kathy Wybourn, DNV-GL

There are many questions from the industry that I am routinely asked regarding the new FDA FSMA Proposed Rule for Food Traceability. The following are a couple of the questions and answers.

Does the proposed rule apply to importers?

Kathleen Wybourn: Yes. The proposed rule will apply to all persons, who manufacture, process, pack, or hold foods on the FTL (foods on the Food Traceability List), which does include food importers, who engage in such activities. However, persons, who do not physically possess food, are not engaged in “holding” of food within the meaning of the proposed rule. This means that some persons, who import food, may not be subject to the rule, because they do not “hold” the food. As an example, a person, who coordinates the import of a listed food, but never takes physical possession of the food, would not be subject to the rule; while a person, who imports a listed food, and they physically possess it, would be subject to the rule, unless an exemption is applied.

Does the “one step forward and one step back” meet the requirements of the FDA FSMA Proposed Rule for Food Traceability?

Wybourn: No. The nearly 20-year-old requirement for tracing will not meet the new requirements of the new rule. The FDA’s proposed rule requires food and beverage companies to include the following records: a) companies should maintain a list that includes the description of all FTL foods shipped, along with a traceability product identifier; b) companies should also have a description of traceability reference records, and how different information is linked, such as purchase orders and bills of lading; c) companies must also develop traceability lot codes that identify the types of food at any point, when it is originated, created, or transformed.

Kathy Wybourn, DNV-GL
Kathy Wybourn, director of food & beverage, USA & Canada at DNV-GL

About Kathleen Wybourn, Director Food Safety, DNV GL North America

Kathleen began her career in food manufacturing at the NutraSweet Division of GD Searle/Monsanto where she held various managerial positions including managing analytical and microbiology labs, quality control, quality assurance, supplier audits and operations. Since leaving food manufacturing, Kathleen has worked in various food safety auditing management positions, including Director of Operations at the GMA as Director of the GMA SAFE program.

In 2008 Kathleen joined DNV as Director of Food Safety Solutions where she is responsible for the Food and Beverage division of DNV GL – Business Assurance. Kathleen has written articles on Food Safety Certification including: First Look: GFSI Adds New FSSC 22000 Standard, WAL-MART’s Magna Carta for Auditing, and Navigating the Jungle of Food Safety Standards – all published in various Food industry magazines. Kathleen was instrumental in the study conducted at Michigan State University on Food Safety Certification in the US titled “Food Safety in the U.S. Supply Chain – Consumer and Food Industry Perceptions.” Kathleen is very active with GFSI, having served on various Technical working groups and speaking at the GFSI Global Conferences.

Kathleen has a Bachelor of Science Degree from Northern Illinois University and an MBA from Loyola University of Chicago.

Content Sponsored by DNV.

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

For security, use of Google's reCAPTCHA service is required which is subject to the Google Privacy Policy and Terms of Use.

I agree to these terms.