On 7/13/20, the U.S. Food and Drug Administration (FDA, USA) released its system modernization program to guard food safety. (1) Under the New Era of Smarter Food Safety initiative, launched in April 2019 to implement the Food Safety Modernization Act.
Food security in the US, premise
The Food Safety Modernization Act (FSMA), enacted on 4.1.11 by then-President Barack Obama, is the first structural reform of the regulations protecting food safety since the Federal Food, Drug, and Cosmetic Act of 1938. The reform was inspired by European food law, as discussed in more detail. (2) In a modern approach to food safety that is based on registration of all operators, integrated supply chain responsibility and self-control, and risk analysis.
However, the reform was not enough to achieve an acceptable level of food security. Now as then, the prevalence of food poisoning in the U.S. is double the planetary average estimated by FAO and WHO(World Health Organization).
It is easy to understand why ‘something’ did not work. European operators, on the one hand, have been accustomed over the decades to being subjected to variously prescriptive and ever-changing national directives and standards. Their adaptation to the rules introduced in the new millennium-from the General Food Law (EC reg. 178/02) to the Hygiene Package (EC reg. 852, 853/04 et seq.)-has been challenging and still is, particularly with regard to the HACCP system. But in Europe, the cultural background on food safety was sufficiently solid. Not so that of operators in the U.S., who were instead accustomed to norms dating back to an earlier geological era, before World War II.
Food security in the U.S., the new program
The Blueprint for the Future-literally, Program, or Model-is presented by FDA as a strategic plan on food safety that will guide activities in the years to come. Specific actions and timelines, not specified in the document, will be shared in accordance with the public consultation and transparency procedures that effectively characterize the Agency’s work. From a governance perspective, in this regard, the European Union and its member states still have much to learn.
FDA Commissioner Stephen M. Hahn, in presenting the Blueprint, highlighted how the Covid-19 pandemic has highlighted imbalances in the food supply chain and critical issues in food delivery services in particular. (3) The rapid transition to digital, after all, represents both a challenge and a great opportunity to redesign processes and material flows, incorporating the crucial elements to ensure security of supply.
Therefore, digital technology should make it possible in the next decade to ensure traceability and manage food crises more effectively. On a path aimed at developing a culture of food safety and reducing food contamination. Digitization may also facilitate data availability and processing, with a view to improving predictive analytics.
A New Era for Smarter Food Security, the 4 key elements
The 4 key-elements of the Blueprint for the Future are clearly laid out in Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety, to which we refer. (4) The idea of ‘smarter’ food security, coupled with the use of technology as a driver of change, is articulated as follows:
1) End-to-end traceability
Traceability-established in the EU as mandatory from 1.1.05, from farm to fork, in both food and feed chains-was introduced in the U.S., in theory, in 2011 (FSMA, Section 204). But it has not yet been implemented. In 2019 FDA has committed to adopt a rule by 8.9.20 to begin tracking high-risk foods of which it will compile a list. With a view to adopting a final rule by 7.11.22.
Technological developments could allow authorities, virtually, to implement end-to-end traceability throughout the entire course of the star-studded food supply chain. A very ambitious goal, the achievement of which postulates several actions:
– Definition of standards, for data recording and transmission,
– interoperability of systems,
– incentives to apply, on a voluntary basis, to as many products as possible,
– development of blockchain platforms, including at the agency itself, which is to develop data processing systems.
2) Predictive analysis and risk management
Predicting risk-or at least intercepting it early-is a crucial goal that affects North America as much as Europe and the rest of the world. Technology can play a leading role, to enable the recall of contaminated food before it reaches the consumer. FDA intends to work on several fronts:
– Big Data. Introduce standards in sampling and analysis methods. As well as in reporting formats to health authorities, which must include the causes of safety flaws found on each foodstuff. The agency aspires to create a database(data trust) where to bring together large volumes of data generated by the supply chain, laboratories and the public sector. With the idea of processing Big Data to increase the likelihood of predicting and mitigating future contamination events,
– predictive analytics, AI. Artificial Intelligence (AI), we would add, has proven to be very effective and accurate in numerous studies that have predicted the deployment of Covid-19 in various contexts. FDA aspires to apply AI to food safety. Adding non-traditional data sources (e.g., rainfall, temperature, humidity. And why not, we add, analysis on soils and animal health). In addition to those provided by existing tools, such as
GenomeTrakr
e
PulseNet
,
– coordination. ‘Domestic mutual trust’ is an initiative to promote collaboration between states in both prevention (methods of data collection and analysis, frequency of controls based on risk analysis) and criticality management (from their analysis and categorization) is the weak side of many systems. Including the European one, as noted above,
– inspection, training and compliance. FDA plans to evaluate the feasibility of new inspection tools, including remote inspection. A prospect that the lockdown has also highlighted in Europe and indeed deserves to be explored. Also considered is the possibility of strengthening the cooperation of authorities with supply chain operators, which in the EU was itself already provided for in the first regulation on official public controls (EC Reg. 852/04), with a view to their optimization, but without having reached maturity.
Optimization and public-private interaction in controls can be facilitated, as already envisaged in the EU, by the implementation of food safety management schemes that comply with the GFSI(Global Food Safety Initiative) Benchmark. As FSSC 22000, based on the ISO 22000:2018 standard. FDA considers increasing the use of audits by accredited third-party entities. As well as that of exploring industry’s use of sensor technology (and its sharing with authorities) to strengthen monitoring of critical control points.
Rapid pathogenic bacteria testing tools are not mentioned in the program, although they can play a crucial role in intercepting food contamination before it reaches the shelves. Tools also being continuously developed in Europe by innovative startups such as Italy’s Instabact.
3) ecommerce, food delivery, distribution and restaurants
New business models are also subject to special evaluation. The unstoppable growth of ecommerce and food delivery has highlighted new food safety issues. And it is necessary, among other things, to update the Food Safety Modernization Act (FSMA) itself, which to date does not consider the critical stage of the so-called last mile. The delivery of food and ready-to-eat food to the home – on behalf of physical and digital retail, restaurants and public establishments – is contracted out to a wide variety of parties, generally lacking food safety training. (5)
Therefore, the federal agency plans to work with courier and delivery groups (UPS, Uber, DoorDash, etc.) to give instructions on how to handle food. Also encouraging the use of technology to monitor risk factors (e.g., weather, temperature). Smart packaging or labels may finally get the application they deserve.
Distribution and restaurants should then be incentivized to ‘modernize’ self-inspection procedures. Once again there is a call for technologies, such as Time Temperature Indicators (TTIs) and new digital tools that suggest behaviors (e.g., handwashing) and intervention strategies. As well as the desirability of introducing new federal regulations to ensure the consistent implementation of the Food Code at public establishments and distribution.
4) food safety culture
Dulcis in fundo
, the culture of food safety. Which should be promoted to all supply chain operators and consumers. Through social marketing campaigns, with the collaboration of influencers who can offer useful role models of behavior to ensure safe food. As well as training programs, education and inspection tools that also consider behavioral science principles. Interaction with consumers on food safety issues could in turn be encouraged through apps.
Next steps
The project is described as a work in progress, ‘a living document that aims to keep pace with new food technologies, food production and delivery methods, and new tools for supervision.’
Stakeholders are invited to provide feedback on agency initiatives. Useful food for thought, even for the Old Continent.
Dario Dongo
Notes
(1) New Era of Smarter Food Safety: FDA’s Blueprint for the Future . FDA. 7/13/20, https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-new-era-smarter-food-safety-blueprint
(2) For more on the Food Safety Modernization Act (FSMA) see the freeebook Food Safety, Mandatory Rules and Voluntary Standards, at https://www.greatitalianfoodtrade.it/libri/sicurezza-alimentare-regole-cogenti-e-norme-volontarie-il-nuovo-libro-di-dario-dongo
(3) Remarks by Dr. Hahn on the release of a Blueprint for the New Era of Smarter Food Safety. FDA. 7/13/20, https://www.fda.gov/food/new-era-smarter-food-safety#video
(4) FDA. Food for Thought: Ideas on How to Begin a New Era of Smarter Food Safety. (Oct. 2019), https://www.fda.gov/media/131682/download
(5) A pioneering guideline on how to ensure food safety in the last mile was published just in Italy, by USSL 7 Pedemontana. V. https://www.greatitalianfoodtrade.it/ristorazione/covid-19-linee-guida-per-la-rinascita-di-ristoranti-e-bar-tramite-food-delivery
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
