On September 21st, the U. S. Food and Drug Administration (FDA) announced a proposed rule change to the Food Safety Modernization Act (FSMA).1 If adopted, this rule would bring a significant change to FSMA and new compliance requirements to food industry stakeholders.
The proposed rule, "Requirements for Additional Traceability Records for Certain Foods" or the Food Traceability Proposed Rule,2 would put into practice the requirements established in FSMA Section 204(d) "Additional Recordkeeping Requirements for High Risk Foods." Generally, the proposed rule would establish new traceability recordkeeping requirements for the manufacture, processing, packing, or holding of foods that the FDA designates are at high risk for potentially creating a public health risk due to foodborne illness outbreaks. These foods are listed on the "Food Traceability List" (FTL) that was released simultaneously with the proposed rule. The list includes 16 types of fruits and vegetables, fish and shellfish, nut butters, eggs, and cheeses.
Currently the FDA regulations for food source traceability require what is commonly referred to as "one-up, one-back" recordkeeping; meaning, the food industry is only required to identify the immediately prior food source in the supply chain and the next subsequent recipient in recordkeeping. The Food Traceability Proposed Rule would significantly enhance supply chain recordkeeping by requiring detailed records be maintained relating to tracking of critical events throughout the food supply chain timeline beginning with growing and including shipping and receiving of food items, and processing or transforming food items.
Why is FDA taking these steps?
Beginning with the enacting of FSMA in 2011, FDA is embracing a more modern, preventive, and risk-based approach to food safety. As outlined in their "New Era of Smarter Food Safety Blueprint," FDA intends to utilize technology tools and actively engage industry to bring about a new, more modern approach to food safety. The Food Traceability Proposed Rule is a step forward in that modernization and safety direction. The primary goal is to facilitate product tracing when foodborne illness outbreaks occur or when food contamination events are detected. FDA intends to be more agile in tracing the source of the contamination to enable a more rapid removal of the affected product from the marketplace, and thereby mitigate or prevent foodborne illness incidences.
What does this mean for the food industry today?
At this stage, this is only a proposed amendment to the rule. No action is required until the rule is finalized. The proposed rule does give the food industry some portent of the future of FDA regulation. FDA is laying the foundation for creating a more standardized system of recordkeeping for food traceability. Reviewing your company's food product supply chain linkage now may produce long term benefits and avoid costly supply chain disruption for the future.
FDA is seeking stakeholder comments on the proposed rule through January 21, 2021. The full text of the proposed rule is available here.
Torres Law can assist in determining how this proposed rule may affect your food-related business as well as provide guidance on other FDA regulatory compliance matters. Contact us today for assistance.
1. Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified as amended at 21 U.S.C. § 350 (2018)).
2. Requirements for Additional Traceability Records for Certain Foods, 85 Fed. Reg. 59,984 (Sept. 23, 2020).
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