Food Safety



The FDA has proposed a new rule “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule).  This is a key part of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FDA Food Safety Modernization Act (FSMA). This was prompted by the many produce recalls over the last several years and FDA now wants the ability to trace and trace a food at every step of the supply chain, according to Frank Yiannas, deputy commissioner for Food Policy and Response at the FDA.

What’s on the list?  The draft “Food Traceability List,” includes the foods that would be subject to the proposed requirements. The list includes leafy greens, fresh cut fruits and vegetables, some types of fish, shell eggs, nut butters, and more. “While limited to only certain foods, this proposal lays the foundation for a standardized approach to traceability recordkeeping, paving the way for industry to adopt, harmonize, and leverage more digital traceability systems in the future. Where possible, FDA has drawn on existing consensus standards that industry members may already be using.”

All Ready-to-eat deli salads are on the list (does not include meat salad)

What prompted this new rule? The existing FDA regulations already require much of the food industry to maintain records to identify the immediate previous sources and the immediate subsequent recipients of foods (commonly referred to as “one-up, one-back” recordkeeping). These requirements form a baseline for traceability record-keeping.  However, the information is still insufficient making it difficult to rapidly trace and link shipments of food through each point in the supply chain.  This, and the fact that recordkeeping systems can be largely paper-based and lack a universal lexicon throughout industry, makes it difficult to trace a product to its original source when a problem occurs.

As a result, the traceability and investigation of many foodborne illness outbreaks have been slowed, resulting in more illnesses and economic loss. If traceability is improved by the adoption of this new rule, the FDA will be able to more quickly identify the source of a contaminated product, reduce the scope of product recalls, and conduct timely source-cause investigations to learn more about how contamination occurred.  

When we look at the current state of traceability across the food supply, we find that even though some food producers, manufacturers and retailers have adopted modern, effective traceability systems, rarely are these systems compatible with each other,” says Yiannas. And still, many other food companies have not adopted traceability systems at all. Simply put, we lack a harmonized system of traceability from farm to fork that is universally understood and utilized.”

At the heart of the proposal is a requirement for those who manufacture, process, pack, or hold a food on the Food Traceability List (FTL) to establish and maintain records associated with specific Critical Tracking Events (CTEs): growing, receiving, transforming, creating, and shipping. For each CTE, entities would be required to establish and maintain records containing Key Data Elements (KDEs). Examples of KDEs include the traceability lot code, the date the product was received, the date the product was shipped, and a product description. The traceability lot code is an important KDE throughout the supply chain intended to establish critical linkages that will help to facilitate rapid traceback and trace forward investigations during foodborne illness outbreaks and recall events. In addition, those subject to the rule would also be required to create and maintain records related to their internal traceability program, which would help regulators better understand a firm’s recordkeeping practices and traceability operations.

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 information for specific foods and date ranges.

More generally, the FDA encourages all food businesses to maintain their traceability records electronically whenever possible, to expedite the identification of traceability information when needed to address threats to public health.”

All varieties of peppers are on the list

“The requirements of the proposed rule would only apply to foods that are on the Food Traceability List, which includes foods that have listed foods as ingredients. The proposed rule includes several exemptions, including that the additional traceability records would not be required after a kill-step (a process that significantly minimizes pathogens in a food) is applied to a food, but documentation of the kill-step application would have to be established and maintained.”

Depending on the supply chain, different monitoring actions will be required. For example, most farm direct-to-consumer transactions are exempt. Key data elements to be recorded occur during the receiving, creating (making or producing a food on the FTL using ingredients not on the FTL), and transforming (changing and/or packaging food on the FTL) of food. CTEs include all pertinent shipping data, including shippers, lot codes, bills of lading, times, etc.

Other examples of exemptions include certain fishing vessels, transporters of FTL foods, farm-to-school, and processors that apply a kill step to FTL foods. 

Available for Public Comment: The proposed rule and draft Food Traceability List are available for public comment for 120 days from the date of publication. The FDA will also be holding three public meetings during the public comment period. Information about the public meetings will be provided in a forthcoming announcement.

For More Information

米国食品医薬品局(FDA)が、「Requirements for Additional Traceability Records for Certain Foods」(特定食品のトレーサビリティの追加記録に関する要件)という新しい規則を提案しました。これは、FDAの「スマートな食品安全性の新時代ブループリント」の重要な一部であり、FDAの食品安全近代化法(FSMA)の第204条(d)を施行するものです。この提案の背景にあるのが、過去数年間に多数の生鮮食品が回収されたこと、またFDAが今ではサプライチェーンのあらゆる段階にトレーサビリティを確立したいと考えていることだと、FDAの食品政策・対応担当副委員長、Frank Yiannas氏は説明しています。

リストに含まれるものは? 「食品トレーサビリティリスト」の草稿では、要件の対象となる食品が提案されています。リストに含まれているのは、緑葉野菜、カットされた生の野菜と果物、一部の魚、鶏卵、ナッツバターなどです。「この提案は、特定食品に限定されていますが、トレーサビリティ記録管理の標準化されたアプローチに基本をもたらし、業界が将来よりデジタルなトレーサビリティシステムを採用し、調和し、活用していくうえでの準備となります。FDAでは、業界関係者がすでに使用している可能性のある既存のコンセンサスの標準をできるかぎり使用しています」。


新規則提案の理由は? FDAのこれまでの規則ですでに、直前の調達元と食後の納品先を記録しておくこと(一般に「ワンアップ、ワンバック」の記録管理と呼ばれています)が食品業界のほとんどに対して義務付けられていて、この要件がトレーサビリティ記録保持のベースラインを形成しています。しかし、この情報ではまだ不十分で、サプライチェーンのすべてのポイントで迅速に食品を追跡して出荷されたもののリンクを確立するのは困難です。加えて、記録管理システムのほとんどが紙に頼っていて、業界全体で共有された普遍的な目録がないことから、問題が発生した時にその食品を大元の出所までたどるのは困難です。




この提案の中心にあるのは、食品トレーサビリティリスト(FTL)に記載された食品を製造、処理、梱包、保存する人に課される要件です。その目的は、栽培、受理、変容、創造、出荷から成るCritical Tracking Event(重要トラッキング出来事)、略してCTEに関係した記録を確立し維持することにあります。CTEのそれぞれにおいて、当該業務を手がける事業体は、Key Data Element(主要データ要素)、またはKDEを含んだ記録を確立し維持しなければなりません。KDEの例には、トレーサビリティのロットコード、製品の受領日と出荷日、またその説明が含まれます。トレーサビリティのロットコードは重要なKDEで、サプライチェーン全体を通して、このコードがリンクとして機能することで、食中毒や製品回収が発生した際の調査ですばやく出所をたどれるようにします。さらに、この規則の対象者は、社内のトレーサビリティプログラムについても記録を作成して管理しなければなりません。これにより、規制当局が企業の記録管理の実践とトレーサビリティの体制をよく理解できるようになります。









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