The US Food and Drug Administration (FDA) is currently working to develop a final rule to enhance the traceability recordkeeping for some food products necessary to protect the public health.
US FDA consumer safety officer Amelia Tetterton said the agency is receiving comments and expects to publish the final rule set forth in the FDA Food Safety Modernization Act (FSMA) section 204 governing food traceability requirements by Nov. 7, 2022.
“If finalized, the rule would become effective 60 days after it is published in the Federal Register. Compliance date for all covered entities would be two years from the effective date of the final regulation,” she said in a webinar.
Tetterton said the proposed rule requires covered persons to maintain records for food on the food traceability list (FTL) that will support more efficient and accurate traceability of potentially contaminated food.
“When a food borne illness outbreak occurs, (there is a) need to quickly identify and remove contaminated food from (the) market to avoid additional illnesses/deaths,” she said.
Tetterton said the food traceability proposed rule also limits the scope of recalls, establishes harmonized information, aligns with current industry approaches, and enhances ability to conduct root cause investigations to identify and apply lessons learned from outbreaks.
“Need accurate information on the food to trace it back through the supply chain to identify the source and also forward to determine how the food was distributed,” she added.
Tetterton said the proposed rule touches the whole supply chain from farms and facilities to retail food establishments, includes both foreign and domestic entities, only applies to certain foods, has some exemptions and partial exemptions, and co-proposal on retail food establishments.
She said proposed requirements include critical tracking events (CTEs) and key data elements (KDEs).
CTEs include growing, receiving, transforming, creating, and shipping wherein records would be required, she added.
Tetterton said required records would need to contain specific KDEs depending on the CTE being performed.
“The KDEs required would vary depending on the CTE that is being performed. The records required at each CTE would need to contain and link the traceability lot code of the food to the relevant KDEs,” she said.
Tetterton further said the record requirements would apply to all foods on the FTL which include foods that contain foods on the list as ingredients.
FTL for requirements for additional traceability records described in the proposed rule includes cheeses, shell eggs, nut butter, cucumbers (fresh), herbs (fresh), leafy greens (fresh), melons (fresh), peppers (fresh), sprouts (fresh), tomatoes (fresh), tropical tree fruits (fresh), fruits and vegetables (fresh cut), finfish, crustaceans, mollusks/bivalves, and ready-to-eat deli salads, according to FDA website.
She added violations of the recordkeeping requirements is a prohibited act under section 301(e) of the Federal Food, Drug, and Cosmetic Act, except when such violation is committed by a farm.
Source: PHILEXPORT News and Features
