Interview with Claudio Gallottini, CEO of Ita Corporation, international expert on North American food safety regulation
The Centro Studi Italia Canada is closely following the recent entry into force, from 15 January 2019, of the Safe Food for Canadians Regulations (SFCR), the reform of the food safety regulation that applicable within the Canadian territory. In fact, there are many questions with operators and experts in the sector, and some uncertainties regarding the applicability of the legislation and the effects on European and, in particular, Italian exporters.
On the one hand, the intervention of Lyzette Lamondin, Executive Director of the Canadian Food Inspection Agency, during the Global Food Safety Conference 2019 in Nice held between February 25th and 28th last year, (Watch the video) seems to confirm that the new legislation will impact on the internal interprovincial trade, on the export of Canadian products and also on imports from third countries.
Other positions insist, instead, on the exclusive traceability of the obligations only to the importers, only responsible for the correct application of the legislation. However, this interpretation suggests that the exporters from third countries will be required to be more willing to meet food safety standards that Canadian importers now have more incentive to request, given the obligations placed on them by the entry into force of the SFCR.
In consideration of the importance of the matter for the export of Italian food products to Canada, on the occasion of the Global Food Safety Conference 2019 in Nice, we wanted to ask some questions to Claudio Gallottini, CEO of ITA Corporation, international network present on both sides of the Atlantic, thus supporting both US / Canadian importers and European operators interested in exporting to these markets.
Gallottini is a recognized international law expert in North America: "Trainer of Trainers" for many Alliances created by the FDA in the USA for the official training of operators in the Agribusiness and Regulatory Auditor sector on the Food Safety Modernization Act (FSMA) USA, to which the Canadian legislation was inspired.
Claudio Gallottini, Ceo Ita Corporation and global expert and trainer about northamerican food safety laws
Dr. Gallottini, in what context can we frame the Canadian and American regulatory reforms regarding food safety?
In 1961 the United States was engaged in a campaign of missile launches aimed at conquering space and NASA and the US Army were unable to create food formulations for future astronauts. In the void the products disintegrated and also had to be safe. A consultancy Firm, the Pilsbury, was involved at the time, and finally got safe products that do not disintegrate.
In 1969 the embryonic Hazard Analysis and Critical Control Points (HACCP) system was born which, with a preventive approach, guaranteed the production of safe food. Only at the end of the seventies, it became what we know today. Later, due to the need to regulate world trade in the WTO (World Trade Organization), the Americans proposed this system to a Commission created by the FAO and WHO (World Health Organization), called Codex Alimentarius (based in Rome within the FAO), and since 1990 Codex and the HACCP system have become the reference for food safety for all WTO member countries.
In 1993 the current European Union will take its cue from the Codex for the first directives which then in 2002 will generate the Hygiene Package (current regulatory framework on food safety).
For the past three years the Codex has reviewed the HACCP system and last November in Panama the draft of the new HACCP was presented during the "Fiftieth session of the codex committee on food hygiene
What are the innovations introduced?
During the conference organized by the Global Food Safety Initiative (GFSI) in Nice, there was a lot of talk about the USA and Canada, but also about the HACCP that will come, that is what will happen in Europe soon. Dr. Guilherme Antonio Da Costa, Chairperson Codex, summarized the new HACCP, in line with the new US and Canadian regulations.
- First of all, reference is made to the concept of Food Safety Culture, which transmit awareness to the individual operators because they are carrying out a specific task and how they should do it to achieve the objective of food safety.
- Furthermore, the Preventive Controls are introduced, very strong preventive measures to be implemented only when dangers particularly harmful for the final consumer may be present in the raw materials or in the ingredients used for making a food product. These dangers are called "Serious Adverse Conseguence or Death to Human or Animal" (SACODHA).
At the event, both the Food and Drug Administration USA (FDA) and the Canadian Food Inspection Agency (CFIA) explained how their new FSMA and SFCR requirements work, based on these same principles: food safety culture and preventive controls.
Furthermore, it is very likely that the new EU Hygiene Package, also in view of a transatlantic regulatory harmonization, will align itself with these regulations.
An example? In Europe we have "Prerequisites" which we call GMP (Good Manufacturing Procedure). We also have English, German or international volunteer standards added, called PRP (Prerequisite Programs). In Canada and the USA, however, there are a number of mandatory basic prerequisites which are GMPs, SOPs (Standard Operating Procedures) and SSOPs (Sanitary Standard Operating Procedures).
Then there are the Prerequisites deriving from international standards and, moreover, today, the new regulations are added to the Preventive Controls (No. 5 in the USA, No. 7 in Canada). The latter are not planned in Europe.
Some argue that there will be no changes for Italian operators involved in exports both to the USA and to Canada? What can you tell us about this?
I look at my country from abroad and find, working with importers from overseas, that things are not very clear. The FSMA, which would be the American Hygiene Package, has been confused with one of the thousand voluntary standards and it is not clear why, being a mandatory federal regulation.
Of the SFCR, the Canadian legislation, nobody knew anything until last December, and in collaboration with the Centro Studi Italia Canada, we have organized many conferences on this topic in the last two years. I’ve learned about sector communications that speak normally only to Canadian companies, when instead it will also apply to our reflex operators, who as “Foreign Supplier” will have to demonstrate to Canadian importers to respect the new requirements of the Preventive Controls.
However, I am not afraid that we will have problems adapting to these changes. This phase reminds me of the early 2000s, when HACCP came into force in Europe and there was widespread confusion. After a few years, once the operation was understood, the system was fully operational. In this case, too, the value of exports justifies our healthy attention to these rules.
A screen capture taken from the Canadian Food Inspection Agency website: http://www.inspection.gc.ca/food/imports/step-by-step-guide/eng/1523979839705/1523979840095#a2.3
In short, what has Canada changed in its food safety legislation that impacts our businesses?
On the one hand, Canada has simplified the subject, in the sense that it has brought together 14 different regulations into one, the SFCR. It complicates the fact that now from meat to wine, through fruit and cheese, the entire industry must adopt Preventive Controls with a different form and approach.
In Italy, in 20 years of HACCP, we followed the "Simplification" route. In particular, with regional autonomies in terms of health, Regions such as Piedmont, Lombardy, and Emilia Romagna have adopted an hypersimplification on the application of HACCP. North America, on the other hand, and Canada in particular, adopt the system as originally intended.
Let me give an example. If the refrigerated storage does not work as intended, on a particular product "could develop - we say in EU - Pathogenic bacteria". This is what we read on the documents of major Italian food companies, market leaders.
In Canada, instead, we must write: "E. coli and Salmonella galloprovincialis could develop". Therefore identifying the danger with a name and surname is mandatory, as it is also to justify its affirmation on scientific sources, internal studies or publications and conference proceedings, regulatory agencies or trade associations. For us, today, this last step alone is already a revolution.
Another example. The recordings of the various activities, for example of temperature monitoring, are simplified in Italy, in North America they have a legal protection valueHere these are some trivial aspects, but substantially different and divergent.
What risk Italian and European operators will face, referring to the Canadian legislation?
The problem as I have tried to explain is not so much about know how, but about method and content. Recently, in Europe, the Canadian Food Inspection Agency has carried out audits, releasing non-conformities related to the management of hazards and their justifications. In Italy a well-known pizza brand has seen its products blocked at customs because they had not identified a licensed importer. This new law updates a system previously based on a structure of 25 years ago. What will be needed is to support our operators to understand this new approach.
To help our operators, I will be present at the "15th Annual Food Safety Summit" in Toronto on 2 and 3 April, where I will meet the CFIA for further application clarifications. The focus of the conference will be the application of the SFCR. The suggestion for all operators is however to get an idea on the official websites of the North American agencies, always very detailed, try to participate in some official forums and be wary of those who simply say that nothing has changed.
Paradoxically, in relations with North America, the problem is very often not represented by the Regulatory Agencies, but by the market, which through Retail and large retail chains, to raise the level of self-protection and lower the business risk through third-party Audits, impose strict compliance with national regulations.
This is the case in the USA where the Accredited Third Party Certification Rule now provides the FSMA Certification of the Foreign Supplier. The same option was also adopted by Canada, which will be available to importers, as clearly stated by Lyzette Lamondin, during the GFSI 2019. In other words, importers are required to verify that the imported food has been produced in a way that complies with applicable safety standards.