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Hearing of the Senate Committee on Health, Education, Labor, and Pensions - Developing a Comprehensive Response to Food and Safety

Location: Washington, DC

Hearing of the Senate Committee on Health, Education, Labor, and Pensions - Developing a Comprehensive Response to Food and Safety

SEN. KENNEDY:The committee will come to order.

The most basic duty of any government is to protect the safety of the people it serves. A recent report to the FDA Science Advisory Board raises troubling questions about the administration's ability to meet this basic responsibility with regard to food safety and many other areas where American families count on FDA to protect their health. And instead of improving matters, the White House is poised to make them worse by threatening a veto of the very bill that funds the FDA.

The report's conclusions cannot be more stark or more shocking. The FDA does not have the capacity to ensure the safety of food for the nation. FDA does not have the capacity to ensure the safety of the food for the nation.

FDA's ability to provide its basic food system inspection, enforcement and rule-making function is seriously eroded, as is its ability to respond to the outbreaks in a timely manner, and to develop and keep pace with the new regulatory science needed to prevent future problems.

Every time American families go to the grocery store, they worry about the safety of the food that they buy. Every time parents buy toys for their children, they worry if the paint is contaminated or the materials are defective. They ought to be able to count on the FDA and other health agencies to stand guard for them, to use the latest and best science to protect them, and to stop at nothing to detect the dangerous products.

But the Advisory Committee report reveals that FDA's promise to protect America's families is too often an empty one because of the starvation budgets and absent leadership that the FDA has endured in recent years. The plain truth is the FDA doesn't have the money it needs to do the job it has to do.

If the problems revealed by the report were confined to food safety, they'd be disturbing enough. But the study shows that the effectiveness of the entire agency has been eviscerated by neglect.

The major findings of the report read like an indictment. Finding number one: The FDA cannot fulfill its mission -- the FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.

Number two: The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.

And finally, number three, the FDA cannot fulfill its mission because its information technology infrastructure is inadequate.

I'm pleased that we are joined by Secretary Leavitt today, and I welcome him to our committee. And I hope he will take this opportunity to explain to the American people how FDA has been allowed to reach this sorry state.

I also look forward to a thorough examination of how to improve the food safety. Even a brief review of recent food safety concerns must ring alarm bells in every community. Salmonella was found in domestic peanut butter. Botulism was found in chili. An adulterant from China pet foods led to illness and deaths in cats and dogs. An E.coli outbreak in spinach from California last summer killed three and sickened more than 200 others.

I don't have to look far to see the threat from E.coli. On Cape Cod last month, we were told to boil our drinking water because it was contaminated with these dangerous bacteria.

The administration's food safety plan offers recommendations on improving food safety, and I look forward to hearing Secretary Leavitt's discussion on this proposal. However, many experts believe we ought to do far more, and I look forward to the views of our distinguished panel on the matter.

Both the European Union and the Japanese have more robust food safety programs than we do, and we can learn from them. More significantly, they have much stronger programs to police imported food, combining inspections in the country of origin and testing of imported foods, and we should be able to do at least as well.

We need to give the FDA the tools it needs to identify food safety problems more quickly and respond more effectively. Most importantly, we need to focus on preventing outbreaks in food. I know the secretary's proposal is going to talk about the issues of prevention, and we'll have a discussion on these matters.

Each part of the food industry must have an effective plan in place to prevent hazards in the food it makes and markets. Preventive controls aren't new, and they work. FDA has had regulations in effect since 1973 to require safety processing for many canned foods. Because of these regulations, there are now virtually no problems with botulism in these foods.

FDA issued regulations in 2001 to require safety processing for juices after E.coli in apple juice killed or injured children. Most manufacturers now pasteurize their juice, which eliminates this contamination.

And despite the effectiveness of these regulations, the administration plan proposed to expand this authority only with major limits. Under the proposal, FDA would be able to impose preventive controls only for foods that have repeatedly -- only for foods that have repeatedly been associated with serious adverse health consequences or death; a much different standard than what this committee approved in terms of the FDA earlier with regards to the prescription drug.

Essentially this provision is a requirement that people be injured or even killed before FDA can act. Such a requirement undermines the basic goal of preventing illness. Every manufacturer should be required to implement effective and preventive controls. Now we must give the FDA the authority to enforce the requirement before people are injured, not make them wait until the damage is done.

The Health Committee worked together this year to reauthorize user-fee programs that provide significant resources for FDA. We need to be similarly creative to meet the agency's other pressing needs.

It is a privilege to work with Senator Enzi on this hearing, and I look forward to working with him on our committee and our committee colleagues to develop a response to food safety.

Mr. Secretary, we welcome you. We have the extraordinary circumstance where the head of the FDA had asked the Science Advisory Committee to give guidance with regards to its agency, what it needs in terms of expertise and science advice, and they made a series of recommendations on it and what could be done in terms of safety.

So we want to give credit to the agency itself in trying to look at itself about how it ought to improve itself and for going outside and asking the distinguished panel, who I think have demonstrated with their recommendations a willingness to give us sort of the unvarnished situation, the evaluation which I think the American people are entitled to.

You have gone and traveled the world in terms of the food safety, and you've been kind enough to come brief me -- I'm sure you have the others -- about what you have been attempting to do. But you've landed on a hot spot right now, because with this report, it has to be of central concern to American families, and with the issue that is being raised by this advisory panel in terms of what is needed in terms of the resources to be able to move ahead to give the protection to the American people in food safety and be confronted with the president stating that he's going to veto the legislation, the funding that would help address these various needs.

And that's just around the corner. All of these have come together in terms of the public policy issue. We have a core, unbiased series of recommendations which are about as fierce an indictment in terms of a governmental agency I've seen in 45 years of being in the United States Senate, certainly with regards to the health panel. And as someone who's been deeply committed to the FDA, as others have on this panel, and it's been a bipartisan effort. We've worked very closely with both Senator Enzi and Senator Burr, Senator Harkin who has been a real leader, Senator Murray and my friend Senator Hatch as well on it.

And now we have the clear recommendations of the appropriations on what is necessary to move ahead, and the president, on this, has indicated -- the president's request was $467 million. Senate appropriations recommended 522 (million dollars), not an overly dramatic increase, but at least a very important down payment to try and sort of address this. And now we're facing a president of the United States that they say he's going to veto it.

And this has to be, for every family in America that looks to this agency, every family looks to this agency in terms of their food safety, that goes down to that market today in terms of it, has to ask, what in the world is going on here? We're going to give you a chance to speak to that. But before, we'll hear from our friend Senator Enzi.


SEN. KENNEDY:We've been joined by Senator Harkin, Senator Burr, Senator Allard, Senator Murray.

I'd like to here have the chairman on the Agricultural Committee -- they have, obviously, interest in food safety and eggs, poultry, meat. And I might ask Senator Harkin to say a word and then Senator Burr, if you want to reply -- I don't want to cut off the others who'd like to get the hearing, but I do think there's a special set of circumstance when we have both a member of our committee and someone who's involved in the issues of food safety as much as Senator Harkin is.

So Tom, I'd be glad to hear and then I'd be glad to have a word from our other side here and we'll get on with the secretary.


SEN. KENNEDY:Thank you very much, Mr. Secretary. And I was looking through your report earlier, and it has the features that you mentioned here. I looked at it in terms of the prevention, what's happening, you know, currently, what is the authority that you need in order to deal with the challenges that you're facing. And you've reviewed those.

I'm concerned about the current situation. As I'm looking down the road, I wonder how we're going to be able to build in the future if we haven't got the underpinnings that are out there at the present time. And this advisory committee has basically questioned the whole scientific work force and infrastructure underpinnings when they're talking about not having the adequate kinds of investment and information technology and the use of antiquated equipment out there at the FDA and having to bring in people that had retired in order to try and repair equipment that they have out there, because it's so inadequate. And that the total number of inspectors are down. And the kind of scientific work force, the difficulties that they're getting and the challenges, I think that there were some educational issues, and the rest were working on those matters.

But the basic kind of core factor about the agency and it being able to be able to function. Money doesn't solve everything, but it is an indicator of a nation's priorities on this. And this is an agency, we have some of the able and gifted advisory. I mean, I think the chairman of FDA is to be commended to request a review about where the agency is and what it needs. I mean, that's a bold kind of requirement. It could have been done in-house, and I think if it had been done in-house, a lot of this would have been smoothed over.

But we've got very distinguished individuals that have been part of that advisory committee, and they have pointed out the extraordinary challenge that it's facing. I mean, how are we going to do in terms of looking at the future when you got the underpinnings that are crumbling at the present time? And it does seem to me we've got the central challenge now in order to try and look down the road and how we're going to coordinate different kinds of inspections in the future, bring it on into the next century, the FDA. We have to talk about what is the basic underpinnings, which this report has put out and stated. And when you get these kinds of conclusions that they have on it, we would expect from you to have the FDA does not have the capacity to ensure the safety of the food of the nation. We can't worry about, you know, where we're going to be in 10 years from now when it's talking about the current situation. It isn't saying "didn't have" or "will not." It does not have the capacity to ensure the safety of food for the nation.

Now, I think there are a lot of good things that are happening out there in, and they've been mentioned in the course of this morning's hearings. But when you have an FDA does not have the capacity to assure the safety in food of the nation and they have specific kinds of findings in terms of scientific base eroded, scientific organizational structure is weak and talks about the science -- work force in information technology, it would seem to me that we have to get that in shape in order to be able to build on the follow on which you've talked about in your report. And we'll get into some of those matters as well in the time that I have left on it.

But I would think the American people would want a sense of urgency as their person that is leading the agency, that is going to give a sense of urgency about how you're going to respond to that kind of effective indictment. I think that's what they're waiting to hear. And I want to just give you an opportunity to address that.


SEN. KENNEDY:Well, you might have that new fancy system, but if you have an FDA that has broken information technology equipment over there in the agency today, you can have the most dramatic system on paper that there is in the world and it ain't going to work. It ain't going to work.

And this Advisory Committee went to the core, to the basics about what that agency needs. You're going to the basement, what is going to be necessary out there to coordinate. And it's nothing new. Many of us who have been following this know and have been out to the agency have seen this for ourselves. I haven't been out there now for two or three years, but I've been out there. And it was at that time these points, which were made by this independent scientific agency, with this kind of indictment about what is happening there. You can have all of these other kinds of actions that you're talking about internationally.

My time has expired, but I will try and get back to question you about them. But if we don't deal with what this scientific agency says now, I think we are basically betraying the commitment that that agency has to the American people in terms of protecting them and their food supply.


SEN. KENNEDY:Thank you. Mr. -- thank you, Mr. Secretary.

I just want to mention one last point here with regard to the advisor -- FDA Science Advisory and I'll submit some other questions. The -- I -- this is what they have pointed out with regard to resources.

In the recent executive order announcing the Interagency Working Group on Import Safety, President Bush stated that the current system must be fixed within available resources. Now this is what they conclude. This is the FDA's Science Advisory Board. "We can state unequivocally that the system cannot be fixed within available resources." That's what they say. This is the advisory committee. They've just made the finding that the system's broken. We're talking about what's going to happen off in the future and they then say, "We can say unequivocally the system cannot be fixed within available resources." Infrastructure improvements to enhance existing laboratories, equipment and personnel will require addition million -- 10 million (dollars) for CFSAN, 40 million (dollars) for ORA -- these estimates do not include funds required to modernize the assessment -- animal-derived products and all the rest of it.

So the question -- this is the Science Advisory talking about the existing system here. We're concerned that -- we've heard your testimony about the future -- what's necessary. They're talking about today, what is the here and now that is threatening -- you know, at least they think -- the agency's ability to provide safety. Now what are you going to do about it? What -- the American people are watching. You're the man, and they want to know whether you have a sense of urgency to make sure there's going to be the adequate resources. Not for this -- you know, this study here. That isn't dealing with the FDA science and technology. This is not dealing with it. So we want to know what you're going to do about their conclusions that the agency is in trouble and needs help. And you're the man. This is the time. What's your response? Are you going to get them additional kind of help and assistance so they can do the job to protect American food supply.


SEN. KENNEDY:SEN. KENNEDY: Well thank you very much.

Tell me, Mr. Young, the point that I gather that you're making is that the food safety -- certainly in the EU, I imagine in Japan as well, is more stringent, more restrictive than it is, than we have currently in the United States. Is that so?

MR. YOUNG: It would be my opinion that the regulations in Japan and Europe are quite different, but the one thing that they share in common is a very strict enforcement, and they are very well defined. They have very well-defined standards, so that the exporters are aware of the standards that they must meet.

SEN. KENNEDY: Well, if they do not meet the standards, in terms of the EU, I think you mentioned that those food products, some of those can be sold to other countries?

MR. YOUNG: The particular action plan that I was referring to was a document that I read a couple of -- a few years ago. And it was -- yes, it was clearly stated in that document that if food did not meet the EU standards, then it could be sold into markets where the regulations were less stringent.

And essentially what that means is that if their -- the rules are clearly stated, that: "This is what we demand;" "This is the quality of product we demand;" "These are the standards that you must meet," then essentially that product could be deemed to be compliant with those rules and regulations.

SEN. KENNEDY: Well, in a practical effect, some of that is sold in the United States. Is that correct?

MR. YOUNG: I beg your pardon, sir?

SEN. KENNEDY: Some of those food products are sold in the United States, but I don't -- they don't meet the European standard, and they can be sold here in the United States?

MR. YOUNG: That could be the case.

SEN. KENNEDY: Well, is it the case? I mean, you're an expert -- I mean, we've got, I've got a limited period of time -- it is the case, isn't it?

MR. YOUNG: It probably is the case. I can't say for certain that those products were sold. But one thing I can state is that products that are destined for Europe are tested before they're shipped to Europe. And I cannot say that the products destined for the U.S. undergo the same level of testing.

SEN. KENNEDY: Ms. DeWaal, do you know that to be the case, or not?

MS. DEWAAL: I think, Senator, that a number of states have actually proven this. They have tested seafood products that FDA is not testing, and they have found illegal antibiotic residues. So, in fact, we think -- and FDA actually, after the melamine incident, FDA actually had to ban certain seafood products that, Senator, they have known for seven years that these products were coming in with illegal pesticide residues -- excuse me, antibiotic residues, and they didn't ban them until after the melamine incident.

SEN. KENNEDY: Mr. Taylor, as I understand the EU acted in 2002 to change the food safety system -- establish a system that focuses on risk, that provides for a rapid response when an unsafe food is found. There is an absolute requirement to be able to trace all food to its source, and to retail. And they have a comprehensive testing on all foods. And countries that import to the EU must be pre-approved in their lists of approval -- approved countries, approved suppliers in those countries, and the foods they are approved to import. Is that your understanding?

MR. TAYLOR: Yes, Mr. Chairman. I think the traceability requirement, in particular, illustrates the commitment --

SEN. KENNEDY: Do we have that type of --

(Cross talk.)

MR. TAYLOR: We do not. We've not implemented that sort of farm- to-table traceability and accountability system here.

SEN. KENNEDY: And do you just -- professionally think that provides a greater degree of safety?

MR. TAYLOR: Well, in traceability -- being able to know where a product came from and the conditions in which it was produced from farm-to-table, is fundamentally important.

SEN. KENNEDY: What about Japan?

MR. TAYLOR: Well, again, the Japanese -- as Mr. Young indicated, have much more clearly defined standards for imports, and higher degrees of inspection and testing than we do. There's no question about it.

SEN. KENNEDY: Don't you think a lot of Americans that might be watching this hearing saying, well, why does Japan, and why do the Europeans have stronger protective systems than the United States?

MR. TAYLOR: Yeah. I think it would be a fair question to ask. It's not as though we haven't known for a decade that our system can be improved in fundamental ways. GAO, and the National Academy of Sciences have been telling us this for a decade. And so it is time to act to build this sort of system on prevention into our --

SEN. KENNEDY: How much additional burden, Congressman Dooley, would this type of a system put on the -- those that it would impact?

MR. DOOLEY: Well, I think what we're suggesting, Senator Kennedy, is that we really have to define that public-private partnership that will most -- be most effective in achieving that objective.

And what we have proposed is that we would mandate that every importer of record -- every importer of food or a food ingredient product in the United States, would have to have a supplier qualify assurance program -- that would ensure that you would have (in fact ?) the food safety audits that would be in place; that would ensure that those companies we are sourcing for, had good management practices in place, sanitary practices in place; that we would develop these set of guidance with FDA; that you would then have the private sector being vested with the primary responsibility of preventing these occurrences.

And one of the reasons why we think this is most appropriate alternative is that we have 190,000 different companies that are registered under the Bioterrorism Act that would be eligible to import food products into the United States today. And we do not think that if you go down a regulatory approach where you'd have FDA vested with that responsibility, that you're ever going to have the capacity and the resources to certify those.

And so what we are suggesting is we work in cooperation with FDA, that they help us set the standards and the guidance where the private sector then is mandated to have the plans in place to ensure that we could have systems that would allow for greater traceability and greater confidence that we are having the food supplier quality audits that were in place.


Thank you very much. Thank you very much.

I want to -- we'll submit -- leave the record open and submit some questions. I think it's been an enormously interesting and valuable hearing today. We've had a good exploration of the issues on food safety today.

The advisory committee report is a clear call for action, and our committee is determined to answer that call, and I look forward to working with all of our colleagues to see that we develop a comprehensive approach to the challenges that FDA faces, both in food safety and in these other areas.

This has been very, very valuable, very useful, and we are very grateful to all of our witnesses. And we will be -- leave the record open for a week. We're going to be submitting some additional questions and calling upon you as we try to fashion and shape a legislative approach to ensure greater protection for American families.

Thank you very, very much, and the committee stands in recess.

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