The US and Europe have a great opportunity to step up their collaboration and provide leadership on global food safety, Michael R. Taylor said in an exclusive interview with EurActiv.
Michael R. Taylor is Deputy Commissioner for Foods and Veterinary Medicine at the US Food and Drug Administration.
Taylor spoke to Sarantis Michalopoulos.
The FDA Food Safety Modernisation Act (FSMA), signed into law by President Obama in January 2011, has been dubbed the most sweeping reform of US food safety laws in more than 70 years. Could you explain the main features of the new law and the reason for your visit to Brussels?
We are here as part of outreach around the implementation of the new food safety law in the US, the “Food Safety Modernisation Act”, which became law in 2011 and we have been working hard to implement.
It’s a very major overhaul of our food safety system which is based on what’s really been learnt over the last couple decades about how to better prevent foodborne illness.
It’s really a mandate to build in to our oversight system, preventive measures in a comprehensive way beginning on farm where fresh produce is grown, and food-manufacturing facilities, and the transport of food and, very importantly, apply the same standards to imports as we apply to the domestically-produced food to able to verify that the imported food is meeting our standards.
This is the comprehensive prevention strategy – that is, in contrast to a historical approach which involved inspection and response to problems, we would find problems and be able to correct them, but this is an approach that says we know how to prevent, and need to be sure that there are recognised standards that everybody is following, to prevent problems from happening in the first place.
It’s a big overhaul of the regulatory system. Many in the industry are doing this and, in fact, these approaches have generally been developed by progressive people in the industry and what Congress has said to us is establish regulatory standards and ensure that everybody is observing the modern preventive measures and very importantly, step up our ability to verify that this is happening.
We emphasised that there are two elements in this law: having the right standards in place, and verifying that they are actually being carried out by the industry.
It’s a big deal for our domestic industry but also for anyone in other countries producing for the US market.
There are a lot of European producers and they have a big interest in how this is going to be implemented and so, we are here working very closely with our Commission colleagues, DG SANTE and who we work with on an ongoing basis on food safety and very much collaborating with them on implementation of this new law. We have daily meetings with those colleagues.
Do you have any plans to harmonise, in the long term, the food safety systems across the Atlantic?
Well, it’s interesting because the standards that we have been directed to establish are based upon widely and internationally-recognised standards. There is a fundamental harmony between our standards and standards that others are implementing in other regions. This is really our part of a process over the last couple of decades through codex, and through other measures to harmonise upwards. I mean standards are rising for food safety. All the expectations are rising for food safety. Standards are rising all over the world and this is part of that effort.
One of the issues in implementing this law is for us to work with our European partners. There are standards that are written a little bit differently but achieve the same level of public health protection.
Then a European producer producing in accordance with those harmonised standards can access our market without necessarily comply with every word of our rules.
So, there will be flexibility in the implementation of the new law.
Yes, there will be flexibility and a built-in harmonisation. What is important is guiding the implementation because the food supply is too diverse, there are so many different kinds of food production and systems and different ways to achieve the food safety outcome that we all desire.
The regulations are flexible and they are premised on being able to line up with other countries that are observing the same high standards, which obviously Europe does, we do… so we think we will be able to operationalise this in a way that will work. For the food safety, but also [in ways that] do not disrupt trade in safe food and nobody wants to do that either.
Will you put this process in the context of TTIP?
We [the FDA] are about food safety, and a public health mission and collaborating with our foreign partners on food safety. I leave the trade process to others. But we do think it’s important to continue to focus on having the right high food-safety standards that consumers from both sides of the Atlantic expect. So we obviously work with our agencies, USDA and other agencies of the US government that are focused on TTIP. We think that if we do our food safety job right we will let the trade take care of itself.
Taking into account the consultations and discussion you have held with the EU partners did you have the feeling that they are afraid the EU imports are “under threat” due to this new Act?
I didn’t get a sense of threat from our DG SANTE colleagues. I think it’s a matter of just working through how our cooperation lies in this new system. If we work together which we are doing, we are confident we will operationalise it in a way that will achieve our food safety verification progress without disrupting the trade.
But again, I think the reason we are here is that we do know that people have questions. They want to be sure they understand the standards, the procedures the US-based importers will be following. We want to be in the position of answering people’s questions and alleviating concerns. For those who are already observing the first tier in modern practices, I don’t think they have to change much of anything they do. Those who are not there will need to improve their food safety practices – whether the US or countries exporting to the US they will have to upgrade their practices.
Our strategy for implementing is very much about educating, giving good guidance, clarifying what’s expected, providing education and technical assistance and training tools to support compliance.
We think it can be operationalised in a smooth way.
What about American inspections in EU food facilities?
What about them? We do a pretty modest number of inspections. I think one our goals in the dialogue with the Commission folks is how we can, as we learn more about the EU oversight system, place reliance on that in a way that will likely over time reduce the number of the US inspections. Because one of the things we realised in implementing this law is that the levels of verification and assurance that Congress is expecting this new system to provide is more than we can do ourselves.
We have to rely on partners, who it is proper to rely on – and certainly that includes the European authorities, and so we don’t want duplicating efforts. We import food from over 150 countries and many of them do not have the same advanced food safety systems that Europe has.
Part of dialogue with our counterparts here is to build the basis for mutual reliance and avoid duplication of effort in overseeing food safety. So we can focus our resources on sources of supply where more tension is needed to be confident and safety.
You said you would inspect food facilities, but before those, come the farms. How can you ensure the effectiveness of the system as long as you don’t follow the food chain from the very beginning?
One of the important features of this law is the mandate to set standards for the first time for prudence production, fruits and vegetables that are going to be consumed fresh without a process instead.
The regulation we are talking about today is the product safety standards, and that will again involve new standards and new direct oversight of farms to be sure that those standards are being met. So that is an important part of this new system.
With respect to agricultural products that are going in the food manufacturing facilities another feature of this system is the responsibility of the food manufacturing facility to do their own supplier verification.
To the extent that there are hazards, potentially introduced at the farm level, that are not going to be controlled in the food facility, then the responsibility of the food process is to ensure that the right measures are being taken on the farm. The focus of this law is really on microbiological hazards that cause foodborne illness.
When a food manufacturing facility controls the hazards – say it’s tomatoes that have been processed in the can – it’s the product that controls the microbiological hazard.
There is not the same concern about practice on a farm but on the other hand if you are sourcing lettuce or spinach and producing a bagged, cut-lettuce product then it matters very much what the conditions are on the farm because there is nothing about the process of the product that takes care of the microbiological hazards. So that manufacturer of the bagged lettuce product will be responsible under the new system to verify that the suppliers are doing the right thing for food safety.
What is your main concern in the implementation of this new Act?
I think in terms of food safety per se that we are dealing with a region that has advanced food safety systems by and large, and we don’t have any fundamental concern regarding the safety of food coming from Europe. I think the challenge is the operational one, where the Congress is expecting there to be verification that on a facility-by-facility basis modern preventative measures are being observed.
The real challenge is operationalising that smoothly, given that just like in the US the food system is so diverse – a wide array of firms in terms of size, commodities and ways of working.
It’s operationalising this new system in a way that works, that is practical towards diverse food systems. So that’s why working directly with industry here, working with DG SANTE is so central for its success.
So you are in direct contact with the food industry in the EU.
There are 45 trade associations coming to the meeting [9 December between FDA representative and EU stakeholders] and we look directly at the industry here. Information is available on our website, they ask very specific questions how the system works in their operations and get answers. We definitely want to be reaching directly to the European industry.
Would you like to add something EU stakeholders could be interested in?
When you think about food safety there are regions in the world with larger challenges and I think we see a great opportunity and of course Europe sources products from all over the world as well, whether seafood from Southeast Asia, China or spices from India and we see opportunities to work in partnership with Europe to provide leadership on food safety globally – to be sharing information, and this collaboration will be good for our markets but also good for global food safety.
The WHO issued a report last week on the global foodborne illness saying that there is a significant global problem – no region is immune from it, but certain regions are more vulnerable to it, and I think the US and Europe have the opportunity to work together to provide leadership on food safety and we are good to do that. We feel like we have good partners in DG SANTE.
Are you generally optimistic?
Yes, of course. If you travel around and talk to people the food safety is in the front line and the food system to a degree unprecedented and that’s a good thing that reflects consumers’ high expectation. It reflects the fact that anytime something goes wrong everybody knows about it which is a good thing and keeps the pressure to the system to continue to elevate standards and be preventive.
- U.S. Food and Drug Administration: FDA Food Safety Modernization Act (FSMA)