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Michael R. Taylor, J.D., National Association of State Departments of Agriculture

Remarks presented by Michael Taylor, Deputy Commissioner for Foods, Food and Drug Administration, at a meeting of the National Association of State Departments of Agriculture, February 5, 2010, Washington, D.C.

How the Food System Will Make Food Safer and How FDA Will Contribute

It is really a privilege for me to be here this morning.  I appreciate the opportunity, just three weeks into my new role as Deputy Commissioner for Foods at FDA, to talk with some of our most significant food safety partners.  It is the state agriculture departments that play such a critical role in our Nation’s food safety system.  So it’s really a valuable opportunity for me to come and say a few things about what we’re doing on food safety and what the state of the play is on some key issues.   

I can’t emphasize enough from FDA’s standpoint how critical the role of the states is to FDA’s food safety programs and to the Nation’s food safety system and food supply.  I see this time today as just the first of a number of opportunities that we’ll have to work together. 

Today, I want to talk just briefly about the food safety legislation pending in Congress.  Then I want to say a little bit more about the essential nature of the partnerships that we have with the states, which would only be heightened by this legislation.  Next I’ll talk a little bit about produce safety and where we are in developing new standards for produce safety. 

Legislation, as you know, has advanced rather far.  We have a major bill, the Food Safety Enhancement Act, that was passed in the House last summer.  The Senate Health Committee passed the Senate version of this bill last fall.  It’s a priority on the part of congressional leadership to bring this legislation to the floor; it’s had bipartisan support in both the House and Senate. 

This is remarkable, because it really reflects the extent to which there’s such a consensus now—not only on the need to modernize our law, but to broaden the direction we need to go to improve food safety in the United States.  It’s really all about shifting the focus of FDA’s program from a great reliance today on solving problems after they occur, to instead focusing on preventing food safety problems. 

Of course, prevention is what public health is all about, and I also think it’s what maintaining public confidence in the food supply is all about.  That shift to prevention is really a key feature of the legislation in that it would require that all food facilities or processing facilities—not farms—have in place modern, preventative control systems.  And of course, the legislation would give FDA legal tools to require preventative systems and to better respond to problems. 

We will continue to have food safety problems.  We’re not getting a zero-risk food supply.  The traceability, records access, and recall authority provisions—and, of course, working with the industry—will enable us to respond to problems more quickly. And one of the most important features of this law from my vantage point is that it will for the first time actually focus on relationships between FDA’s food safety program and those of the states.  It will for the first time call on FDA to leverage state resources, collaborate with the states, and take some responsibility for building state capacity.  I think it’s a breakthrough that Congress now realizes that we shouldn’t have an FDA food safety program and a separate set of state programs on food safety.  There really needs to be one nationally integrated food safety system.

The law doesn’t focus just on domestic issues around food safety.  There’s a big focus on modernizing FDA’s tools for overseeing imports.  Fifteen percent of our food supply comes from overseas.  In some categories, it’s a much higher percentage than that—as you know, three-quarters of the seafood is imported.  At certain times of the year, the fresh produce supply is obviously heavily dependent on imports. 

We’ve got to have the tools to be able to hold imported foods to the same standards to which we hold domestic facilities.  We need a level playing field for consumers and for the industry.  And I think that’s going to be a major breakthrough because our resources at the local level to oversee imports are extremely limited.

I would say the one major issue that remains unresolved in the legislative process does have to do with resources, and we’re hopeful that there will be a positive solution to this.  FDA currently has no user-fee authority in the foods program even though we have user-fee authority in our drug and medical devices program.

The legislation also contains a major new mandate for more frequent inspections by FDA.  If there aren’t enough resources to carry out that mandate, we will be back in the position of not doing what Congress and the public have come to expect.  We’re extremely optimistic about the outcome of this legislation—not just on the resource issue but more broadly.  We really think we will get legislation this year, and we really think it will make a transformative difference in our program. 

As I said, one feature of the legislation is that it will focus on the federal-state partnership.  This partnership is not new—you all know we’ve had partnerships with the states for a long time with respect to retail food safety, dairy, and shellfish.  These have been important foundational programs for FDA. 

What FDA and the states started realizing about 10 years ago is that we need more than those few cooperative programs.  We need more than a few contracts with the states to provide inspections.  We really need an integrated, national food safety system that includes joint planning of inspection work, so that we’re more efficiently using state and federal resources in a coordinated way to inspect facilities and provide the assurance that the public expects.

This means changing the way that we work together in terms of sharing information and being able to mutually rely on each other’s inspection results and laboratory results.  And it means having that information flow more readily among our agencies.  This is critical for the prevention side of food safety, where we work together to prevent problems.  It’s also critical on the response side so that we can work together through our epidemiological investigations and also our regulatory follow-up activities.  This is really going to take the collaboration we’ve had in the past to a whole new level, and FDA is excited about this.  It’s an enormous opportunity for all of us. 

Funding is going to be at the heart of the issue.  We’re obviously keenly aware of the challenges and pressures that your departments are under from a funding standpoint, and we feel that we have a common interest and a common need to be working to solve those problems.  We were able to have added to S. 510—the Senate version of the legislation—a new grant mechanism which, for the first time, would allow FDA to make multi-year grants to state regulatory counterparts.  We recognize that a lot of what states do—in addition to meeting global need and responsibilities—serves national purposes.  And we think the federal government, in thinking about how to have a truly effective and efficient integrated food safety system, has to figure out how to solve not only FDA’s capacity problems but the capacity issues that exist at the state level. 

Let me just close with a couple of points about produce safety because I think it is a good example of what we’re doing in food safety and more importantly, an example of the way we at FDA need to work if we’re going to be successful in implementing this new prevention paradigm.

Produce obviously is a component of the food supply that has been involved in significant outbreaks in recent years.  We want safe produce.  We want people to have confidence.  The last thing we want is for people not to purchase fruits and vegetables because of safety concerns.

Thus, there has been recognition by that industry of the need to create a level playing field with best practices in produce production—not only in the interest of consumers but also in the interest of the industry.  So the industry has called on FDA to establish for the first time enforceable standards for producing fruits and vegetables on the farm.  We know this is a significant step forward.

The legislation includes provisions that would mandate that FDA do just that.  We take this very seriously because from a health standpoint, it’s important to do.  But we are keenly aware of the difficulty of this task and of the complexity of this task.  I, personally, was involved in developing FDA seafood HACCP rules in the early ’90s and I was Administrator of the Food Safety and Inspection Service when HACCP rules for meat and poultry were put in place.  I know about HACCP and preventative controls and the challenges we faced in those industries.  This is much more difficult because of the critical diversity of the commodities involved—geographical diversities, differences in scale of operations, and differences in the nature of operations, such as conventional versus organic. 

This is a hugely complicated problem, and we know that we’re dealing with an environment that is not accustomed to having federal standards.  So we have no intention to approach this in a conventional way where FDA sets a standard and sends inspectors out trying to enforce it in the usual way.  We really have to take a completely different approach, and that begins with investing enormous effort in listening and learning from the community.  And so we’ve already begun taking farm tours, speaking to small and large growers from all over the country.  We’re just beginning that.  We’ve got to listen and learn about what’s really going to work—what’s really going to make a difference in food safety.

How do we do this in a way that really does reflect all that diversity?  We know our rules have to be scale appropriate.  Nobody yet has the answer to what “scale appropriate” looks like, but we know it makes sense.  We have to realize that there are differences in hazards and differences in the way we control hazards based upon a scale of production.  A one-size-fits-all approach can’t possibly work. 

One of the things that has been key is working with our federal partners, and USDA has been a tremendous collaborator with us on this.  We met last year with Kathleen Merrigan, the Deputy Secretary, and really forged a partnership on this project.  Senior USDA staff members have been traveling with us on the farm tours.  One of their leading experts on food safety, Leanne Skelton of the Agricultural Marketing Service, has actually been detailed FDA to help us develop our rules, and to think about how to do this correctly.

We also know that we’re going to need to collaborate with you and your counterparts at the state level when we think about compliance and how we work with a community that’s not accustomed to having these sorts of standards and has all of this diversity.  How do we motivate that community so that we arrive at a good level of protection and have a level playing field and achieve the goals we all share?  We see this as something that’s going to happen through education, through collaboration with you, and through coordination with people working at the front lines through Extension and the Agricultural Marketing Service’s various certification and audit programs.  We see a whole mix of activities that are going to be needed to move the community along. 

As part of our rulemaking process, we will publish proposed regulations.  We’re also going to put out a white paper that’s going to be based on input from the community and that’s going to begin to lay out ideas for how we collectively move this industry along to where, again, we can all have confidence in the products that are being produced. 

So I go through that quickly just to illustrate that we’re absolutely operating in a partnership mode, and we view NASDA as a real partner in that enterprise going forward. 

I’m glad I had the opportunity to be here today.  This is just one brief opportunity to start a dialogue that I know will continue.