The FDA has finalized traceability requirements under FSMA. The rule takes effect January 20, 2023, but enforcement will be delayed until January 20, 2026. All operations will need to start complying on that date. Operations with sales of less than $25,000 on average over the last 3 years adjusted for inflation based on 2020 are exempt. If a grower is exempt from the FSMA: PSR based on sales under $25,000 it is also exempt from the traceability rule. Growers who sell directly to consumers, sell food to institution programs, produce certain foods that are packaged on a farm, grow food that is rarely consumed raw or grow food that receives certain types of processing are exempt. If a grower sells wholesale and direct to consumer, the wholesale product may fall under the traceability rule.
FDA has developed a “Food Traceability List (FTL)” which is a list of foods for which additional traceability records are required to be maintained. In New Jersey it covers most of what is grown such as fresh cucumbers, herbs, leafy greens, melons, peppers, etc. unless it is considered rarely consumed raw.
For growers who fall under the rule a traceability plan is required which includes:
- How the records are maintained including the format and location of the records
- Description of the procedures used to identify foods on the FTL list
- Description how traceability lot codes are assigned
- Contact person who manages the records
- Farm map showing the areas where commodities are grown and name of each field including coordinates
- Plans must be retained for 2 years.
Records must be maintained for every “Critical Tracking Event (CTE)” which is an event in the supply chain of a food involving the harvesting, cooling or initial packing of a raw agricultural commodity. Along with the CTE are “Key Data Elements (KDE)” which is the information which must be maintained. So what records are required?
- The commodity at harvest
- Quantity and unit of measure of the food harvested (boxes, pounds, etc.)
- Name of the field or growing area including GPS map coordinates
- The date of harvest
- Farm name, address and phone number of the operation
Lot codes will need to be assigned when the commodity is packed. The same lot code will be used throughout the marketing system. These lot code numbers do not need to be attached to each box or container. They do need to be on a bill of lading, invoice, etc.
The next three years will be a learning experience for growers, extension educators and regulators. There are many details in the rule which are not clear even after reading it more than once. At the New Jersey Agricultural Convention & Trade Show Wednesday February 8 in the Food Safety session (2:45-4:45) we will review the latest interpretation of the rule and discuss which records will be required. For anyone who wants more details go to: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.
