On Jan. 20.1.23, new U.S. rules on food traceability go into effect, implementing the Food Safety Modernization Act (FSMA, 2011). (1)
The Food Traceability Final Rule is part of the New Era of Smarter Food Safety Blueprint initiative launched by theFood and Drug Administration (FDA) in April 2019. (2)
1) USA, new rules on food traceability. Foreword
The new U.S. rules on food traceability follow a similar approach to those introduced in the European Union with the General Food Law. Even if they are limited to certain categories of foodstuffs (see Sec. 3.2).
Food traceability-which in the EU has been extended to all food, feed and food contact materials (3,4)-is a crucial food safety risk management tool.
Compulsory registration or authorization of operators involved in the respective supply chains with health authorities is also essential, to identify the actors involved from possible critical issues. (5)
2) Objectives
The primary objective of these rules is to enable the identification in the shortest possible time, assuming knowledge or well-founded fear of food safety hazards, of:
- causes of the criticality, upstream of the supply chain,
- Distribution of the products involved, downstream of the supply chain.
Thus, the function of traceability is to enable risk analysis and risk management, to remove its causes and mitigate its possible negative impacts on public health (through identification and withdrawal and/or recall from the market of the products involved).
3) Food Safety Traceability Rule, the requirements.
Operators who produce, process, package or hold a range of foods (see Section 3.2) must organize appropriate records in order to:
– Annotate Key Data Elements(KDEs), i.e., key data associated withCritical Tracking Events (CTEs), and
– be able to provide the above information to the central authority in critical cases within 24 hours or otherwise within an agreed reasonable time.
3.1) The US plan for food traceability.
FDA has introduced special requirements in the U.S., while not in the EU, regarding the traceability plan that operators must organize.
The traceability plan must include:
- Description of procedures for compiling and maintaining records,
- identification of FTL foods and/or ingredients (see Sec. 3.2) by assigning traceability lot codes (TLCs),
- Recording individual lot movements (TLCs) of FTL foods and/or ingredients throughout the supply chain,
- Geolocation of the crops or farms where the raw materials come from, as well as the names of the farms, at the primary production stage,
- corporate point of contact.
3.2) Food Traceability List
Foods subject to the new rules-Requirements for Additional Traceability Records for Certain Foods-are listed in an exhaustive list, the so-called Food Traceability List (FTL). (6)
This list includes the most vulnerable foodstuffs, particularly from a microbiological point of view (e.g., the cheeses that are neither hard nor frozen, eggs, leafy vegetables, sprouts, fruits, nut-based creams, shellfish fish, etc.).
The new traceability requirements apply to all operators who handle these products, either as such or as ingredients.
4) Classification of foods according to risk levels.
The
Food Traceability List
responds to a pragmatic approach. In fact, foods are classified in relation to their risks(Risk-Ranking Model Food Tracing) based on the following criteria:
- Frequency of foodborne disease and related food security crises,
- severity of toxins, health and social costs of their effects,
- likelihood of contamination,
- potential for pathogen growth, having regard to the durability of the food,
- Average population exposure (consumption spread, average intake).
5) Waivers
Some exemptions are provided in favor of:
- products packaged by the farm with packaging that ensures their integrity and prevents contamination,
- FTL foods that undergo transformations that can significantly reduce the presence of pathogenic microorganisms,
- small producers such as small farms and those practicing direct sales,
- restaurants. An interactive questionnaire is available for users to check possible waivers.
6) Transitional period
Implementation of the Food Traceability Final Rule by all operators subject to it is expected by the compliance date of 20.1.26.
Companies from other countries that wish to export their products to the U.S. are themselves subject to the application of the new rules.
7) Perspectives. Blockchain
The blockchain is the medium-term horizon, the only tool that can guarantee the recording of data in an effective and incorruptible, ‘FDA-proof’ system.
Frank Yiannas, V.Director of FDA, in announcing the new rules in fact referred to this model. After successfully applying it in Walmart. (7) Ad maiora.
Dario Dongo and Alessandra Mei
Notes
(1) FDA Announces the Final Rule for Food Traceability Under FSMA. 15.11.22 https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-final-rule-food-traceability-under-fsma
(2) Dario Dongo. Food security, modernization program of the US system. FT (Food Times). 20.7.20
(3) Reg. EC 178/02, Article 18. For more details see the ebook ‘Food safety and traceability, mandatory rules and voluntary standards‘
(4) Reg. EC 1935/04, concerning materials and articles intended to come into contact with foodstuffs, Article 17
(5) As stipulated in the EU in the so-called Hygiene Package (EC reg. 852/04, 853/04 et seq.). From farm to fork and from stable to table
(6) FDA. Food Traceability List https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list
(7) Dario Dongo. Blockchain agribusiness, from Walmart to FDA in the US, Wiise Chain in Italy. Toward Web 3. FT (Food Times). 9.2.22
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Law from the University of Bologna, she attended the Master in Food Law at the same University. You participate in the WIISE srl benefit team by dedicating yourself to European and international research and innovation projects.
.){kind=link}