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Michael R. Taylor, J.D., Food Safety Summit
Remarks presented by Michael R. Taylor, Deputy Commissioner for Foods, U.S. Food and Drug Administration, at the Food Safety Summit, Washington, D.C., April 14, 2010
I’m honored to be here and have a chance to talk with you today. I was here last year in my professor role at the George Washington School of Public Health, and I spoke about some research we were doing on state and local roles in the national food safety system. In a professor role, you can come in and pontificate and ask others to implement. I’m now in a position of implementing – I’m glad to be in this position, but I realize it’s a whole lot harder to implement than to pontificate. And that’s why I will convey here in my talk that we’re going to need all the help we can get from everybody in this room to be successful.
I feel particularly fortunate to be back at FDA at this juncture on food safety because as everybody in this room certainly knows, we are at a very special moment, and it’s a moment of remarkable consensus among experts and stakeholders about not only the need to modernize our food safety system, but about the principles that should govern it and the direction and strategy we should be pursuing.
We all agree that we need to take a more prevention-oriented approach—this is what public health is all about. The public has confidence in the food supply when it knows that we’re doing everything we reasonably can to prevent food-borne illness.
We all agree that the system needs to be science- and risk-based. Again, for people in the audience, I think this is common sense. But without science, how do we know what the hazards are, how do we know what to do to intervene to prevent problems, and how do we target our efforts? How do we make the most of resources we have? And certainly in government, our resources will always be finite. We have to focus our efforts on where we can get the most public health bang for the buck.
We all agree that the system needs to address food safety comprehensively. This is just a matter of understanding the nature of the food safety problem. Hazards can enter at any point in the process from farm to table, and interventions can occur at any point in the process to reduce hazards. We all know that.
And finally, we all agree that we need a food safety system that holds imported products to the same standards that we set for domestic facilities. And again, this is a matter of basic public health common sense. It’s also what the public expects and deserves.
So we’ve got broad consensus about these principles among the professional community working on food safety. And, as everybody knows, we are looking to Congress in the next few weeks to move forward on the food safety legislation that is going to codify these principles and give FDA a whole new food safety job. This job will be based on these principles of prevention, being science- and risk- based, looking at food safety comprehensively and holding imports to the same standard as domestic products.
We at FDA have a pretty clear idea of what our central role is in this system. It’s the core job that Congress gives us: to set standards and then to ensure high rates of compliance with standards that can prevent food-borne illness. Again, this is what I think the public expects. This is how we can make a contribution to improving food safety and create a level playing field for the industry as well. So we all know what’s expected of FDA to fulfill this vision of a modern preventive, risk-based system.
And I assure you that FDA is very committed to playing this role of setting standards and ensuring compliance with standards that we’re being given by Congress. We’re already beginning to develop the rules that the Congress is going to mandate that we develop. We’re also gearing up in terms of management changes – internal ways in which FDA needs to work to be able to carry out this vision.
But one thing we also know is that while we have this unique role to play, we’re all in this together. We can set standards, but we don’t make food, and we don’t make it safe. That’s the food system’s role and responsibility.
And food safety really depends on every actor in the food system playing their role, carrying out their responsibility for food safety—beginning with agricultural producers, then food processors, transporters, retailers and consumers. In our view, all have a role in this farm-to-table, risk-based prevention strategy for food safety. And food is going to be safer – we’re going to achieve our food safety goals—when everybody does their part.
Again, I don’t think that’s a controversial idea. I believe that’s embraced by all of us who’ve been working on food safety for a long time. It’s exciting to know that we’re now going to be, from FDA’s vantage point at least, given new tools and new responsibilities to make that vision of food safety come true.
So what I want to do for just a few minutes this morning is run through those stages in the farm-to-table spectrum that I’ve mentioned and give you a sense of what we’re already doing, what we envision doing to begin to fulfill the prevention idea across each point along the way. And I’ll begin with the farm.
I think if you read the legislation that’s pending and look at it from a historical context, I think one of the most significant new requirements that will be imposed on FDA will be to develop standards for the safe growing and packing of fresh fruits and vegetables.
We’ve been working on produce safety for over a decade going back to the late ’90s when FDA developed good agricultural practice standards for food safety. But for the first time, Congress is saying that it wants FDA to set enforceable standards for produce safety. We know this is a really hard task. That’s why, as many of you may be aware, we’ve begun traveling around the country holding listening sessions with growers large and small, talking to very diverse constituencies, to learn how we can make produce safer.
When we identify the scientific and technical challenges that arise from the great diversity in this sector – diversity of commodities, scale of operation, growing practices and market distribution practices – audiences actually express sympathy for FDA for being in the position of having to figure out how to establish standards in this area.
We’ve learned a lot already from those listening sessions. We’ve learned that we really need to take account of that diversity across the food system. We do need to have our rules be risk- based in the sense that we need to target efforts and activities that really will make a practical difference for food safety.
Our rules have to be scale appropriate. They have to take into account the diversity of operations and the impact that has on risk. We want to really learn from the community what are the best practices out there, and how can our standards reflect the best practices that have been demonstrated to be capable of being implemented in practice?
The rules have to be clear enough so they actually can be implemented. The guidances that we’ve issued so far give fairly broad direction. How can we make that direction more concrete so it can be implemented and really be enforceable? But also the rules have to be flexible enough to take into account emerging science. We’ve learned this so far from our dialogue with the community.
We have a lot more to learn before we figure out the design of these rules and the ways in which we will implement these rules. We know, for example, that we’re not going to make progress on produce safety in just the traditional regulatory way where FDA sets standards and enforces standards.
We won’t ever be able to, or aspire to, go to the hundreds of thousands of farms that are growing produce. This is going to take a community effort to get to where we need to be in terms of prevention. And so we’re going to be working with that community throughout this process in both the design and the implementation of these rules.
We’ve opened up a docket on produce safety so that folks can submit formal comments to us at this early, pre-proposal planning stage. We’re going to continue listening sessions and meetings around the country. We really welcome the community into our deliberations, even as we await Congress crystallizing our statutory mandate. So that’s produce safety. That in itself we consider to be a huge undertaking and it’s one that we’re gearing up to pursue in a collaborative, effective way.
The second major point on the spectrum involves food manufacturing facilities. Again, this has been a major focus of the legislative deliberations, and we expect Congress, for the first time, to require preventive controls in all food manufacturing facilities. This in itself is a huge undertaking. We’ve done this in the past by establishing preventive requirements for specific commodities such as seafood and juice. We now need to establish preventive controls across the whole range of food facilities that we regulate.
Again, we have enormous diversity and an enormous need to learn what are the practical controls that will be effective in this diverse set of facilities across the country. What are current best practices, what is the right standard of care in different types of operations? So again, we’re going to have to listen to the community in order to do our standards-setting job well in this situation. We’re going to have to draw the community into our deliberations and learn from what people are doing today to improve food safety.
The next point on the spectrum involves transportation and storage. There has not been the same level of focus of late on this point, and thus there’s much less information available to us about what the issues and opportunities are with respect to transportation. I think we all remember the famous Schwan’s ice cream Salmonella outbreak back in 1994, which affected almost a quarter of a million people. This shows the potential for this to be a vulnerable place in the system. We’ve done some other analysis that suggests that there are opportunities to improve practices, but we need much more information before we can know what interventions will be useful.
We are soon going to issue an advance notice of proposed rulemaking on transportation safety issues and really invite the input and the information that we will need to decide what will be appropriate standards to set. The Sanitary Food Transportation Act, an act of four or five years ago, gives us a broad mandate to set standards. We need to examine what that means in today’s world and what would be a useful, meaningful approach to standards setting. Do we know, for example, what proportion of vehicles out there are transporting both food and nonfood products? Is that a real problem? Does that need to be addressed? What do we know about records that are kept, particularly cold chain verification records? And is there a role – is there a need for some standard setting there?
We need to know about illnesses that have actually been associated with transportation issues so we can really understand the magnitude of the problem before we try to devise a solution to it. So again, this is an area where we feel we have responsibility to consider standards, but we can’t set those standards without your engagement.
The fourth point on the spectrum I’ll just touch on is retail. Again, this is an incredibly diverse sector of the food system, both at the grocery level and at the food service restaurant level. FDA has a long history of working with states through the Food Code, promoting the Food Code as a model ordinance for states and localities to adopt and enforce. A lot of good has been done through the Food Code cooperative program approach. We also work with the industry to try to understand what are the right preventive measures we should be taking in retail.
Another thing that FDA has done over the past 10 years is to conduct a survey of practices in restaurants and food service settings. The data have been collected for the third report, and we are working on the trend analysis of the data to document practices at retail. If you look at the picture over the last decade, there’s been improvement in food safety practices in retail, but there also are areas of substantial noncompliance with the Food Code standards in terms of basic areas like proper cooling of a product and employee hygiene basics like hand-washing, which can be, as we know, a significant contributor to food-borne illness.
So this is another example of where we cannot begin to make a dent in this on our own. We need to work not only with state and local agencies, but with the restaurant industry, and we look forward to doing that to figure out how we move forward toward more complete compliance, with implementation of Food Code standards. We don’t need a new paradigm or a new regulatory framework; we need to figure out how to do what we know is needed.
And finally, let me mention the consumer end of the spectrum. Every one I’ve mentioned so far is potentially or actually a regulated entity, where we actually set standards and enforce them. We don’t regulate consumers, of course, but they are what the system is all about. We are here to ensure that the food they receive is as safe as it possibly can be.
But we also have to recognize that consumers are part of the food system. They engage in behaviors that can make food hazardous, can introduce risk. They can engage in behaviors that can minimize risk just like everyone across the farm-to-table spectrum. And so we have to see consumers as part of the food safety system and look for opportunities to enhance prevention there.
There’s been a lot of good collaboration among industry, government and consumers and public health organizations in the Partnership for Food Safety Education, which has been a forum for bringing together people interested in food safety. We think there’s an opportunity to elevate the role of the Partnership. And we think it’s time to figure out how we take what we’ve been doing so far on consumer education to a whole new level that reflects the current reality of food safety. It must reflect new ways of communicating with people, of connecting with people, to get information in the hands of individuals that they will use. We cannot use outdated models of how people learn and how people get information.
So we are working closely with the Partnership to see if we can make an enhanced commitment on FDA’s part, including potentially financial, to help the Partnership help the community develop a strategic plan for consumer education. We need to bring more actors into that effort to make that a positive part of the prevention system so that at the end of the day, we can have confidence that we’re doing everything we reasonably can from the farm to the table to prevent foodborne illness.
So I wanted to just give you that whirlwind tour of the landscape of issues that we’re working on to show the opportunities to improve food safety we see across the spectrum. We don’t feel that at this moment we can afford to not address every major opportunity to be preventive. We must work with the community to catalyze it to make progress at each point along the way.
And that’s really what we’re going to be about at FDA over the next several years as we work to implement the new law and also look at opportunities to enhance what we’re doing in areas that may not be affected by the new law but that are very much implicated in the spirit and vision of the law, which is a comprehensive, risk-based, prevention-oriented approach to food safety.
It is a big system change undertaking. It is a multiyear, if not five- to 10-year sort of process as I envision it rolling out to really transform the system. But I think it will pay enormous dividends in public health and in public confidence. And again, the bottom line is that we’re all in it together. And in my new role, I look forward to working with all of you to make this happen.