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FDA Food Safety Modernization Act--Motion To Proceed

Floor Speech

Location: Washington, DC


Mr. COBURN. Thank you, Mr. President. I wish to spend a few minutes discussing the bill that is before us. Having been a manufacturing manager for 10 years, producing products that came through the medical device industry, and having dealt with the FDA as a manufacturer and then having dealt with the FDA and the consequences of the FDA as a physician over the last 25 years and then looking at this bill that is on the floor today, I think it addresses three things I have talked about, especially in Oklahoma over the last year.

Everybody recognizes this Nation is at a critical point--fiscally, internationally. From the standpoint of foreign policy, it has been impacted by our fiscal problems. But there are three structural reasons why I think we are there, and I think we need to learn from them. This bill provides us a great example.

The first is, as a physician--and I knew it as a business manager--you have to fix real problems. If you fix the symptoms that have been created or the circumstances that have been created by the real problems, you will make things better for a while, but you actually will not solve the underlying problem. What happens when you do not solve the underlying problem and fix the symptoms is, you delay the time and you also increase the consequences of not fixing the real problems.

Second, if you only think short term, you do not have the planning strategy with which to do the best, right thing in the long term. We consistently do that in Washington. Consequently, the CBO put out the unfunded liabilities for Medicare, Medicaid, and Social Security yesterday. It is now $88.9 trillion. It was $77 trillion last year. It was $63 trillion the year before. So we are up $26 trillion in unfunded liabilities that we are going to pass on to our kids in 3 years because we continue to think short term instead of long term.

Then, the fourth thing is to have the courage to stand and say: No, we should not do things that address the symptoms; we should address the underlying problems. No, we should not think short term or parochially; we should think long term and address that issue.

As to the food safety bill, all my colleagues are very well intended in terms of what they are trying to accomplish with it. But there are some facts we ought to be realistic about. We could spend $100 billion additionally every year and not make food absolutely safe. There are diminishing returns to the dollars we spend. But if you look at what the case is: In 1996, for every 100,000 people in this country, we had 51.2 cases of foodborne illness--the best in the world, by far. Nobody comes close to us in terms of the safety of our food. But, in 2009, we only had 34.8 cases--three times better than anybody else in the world. So the question has to be asked: Why are we doing this now when, in fact, we are on a trendline to markedly decrease it? The second question that should be asked is: No matter how much money we spend, is there a diminishing return?

There are a lot of things in this bill that I agree with--a lot. I think foreign food ought to be inspected before it comes into this country and I think those who want to sell products in this country ought to have to demonstrate the quality of it and I think the cost of that ought to be on the person selling the food, not on the American taxpayer. But ultimately that cost will be added to the cost of the food.

I think the recognition of peanut allergy is a realistic one, and I understand the purpose for wanting a grant for that. But as I read the Constitution, that is a State function. That is not our function. The other thing that bothers me about the grant proposals--I walked out of the deficit commission to come over here. I have spent 8 months in that commission looking at the problems in front of this country. We cannot afford another grant program. We do not have the money.

So we can say we are going to authorize it in this bill, but, do you know what, it is not going to get funded next year because we do not have the money. When the interest rates skyrocket in less than a year from now because of our misplaced spending over the past 20 years and our continued short-term decisionmaking instead of long-term decisionmaking, our situation is going to grow even darker. So this bill provides a wonderful example of how we ought to fix the real problems instead of the symptoms of the problems.

The other thing that truly is not addressed is the long-term criticisms the GAO has continually made on our food safety. Senator Harkin has the best idea of all, but he could not get everybody to do it; that is, an independent food safety agency, to where we are not relying on the CDC, we are not relying on the FDA, we are not relying on the Department of Agriculture, that we put them all into one and say: You are responsible for food safety. But he could not sell that.

Ask yourself the question: If you had three different agencies stepping all over each other with different sets of rules with agreements between themselves that they will do certain things, and then they do not do them--that, by the way, is why we had the salmonella problem; they did not follow their own protocols to notify the FDA of the problem--most commonsense thinking people would say: Well, maybe you ought to put all those things into one agency, with one boss and one line of accountability and responsibility.

So Senator Harkin is absolutely right in where he wants to go. We are going to spend $1.5 billion over the next 5 years on this bill that does not accomplish what we need to accomplish, which is what Senator Harkin wants to do--and he is right--and we are not going to fix the criticisms that have been leveled against the agencies by the GAO for 8 years, in spite of the fact, as I stand here and am critical of different agencies, they actually have done a very good job. That is known by the fact that our incidence of foodborne illness is now less than 34 per 100,000 people. Think about that. Think about all the sources of food we get in this country and the diverse places they come from. Yet only 34 people get a staph poisoning or a nontoxigenic E. coli poisoning or a salmonella poisoning or a Yersinia poisoning or a Shigella poisoning in a year. So that is the incidence of illness.

The question is, How do we stop the 10 or 20 deaths a year from foodborne illness? Can we do that? Well, as a physician trained in epidemiology, we could do it. But I will posit we do not have the money to do that because it would take billions upon billions upon billions of additional dollars to ever get there. So we find ourselves in a dilemma.

I commend to my colleagues the reports GAO-09-523, GAO-09-873, and GAO-05-213.

The GAO does a wonderful job telling us where we are failing, and we ought to address everything they raised in these reports.

Even further than that, Dr. Hamburg, around the time we were having the salmonella with the eggs problem, released an egg standard. The bureaucracy took 11 years to develop that standard. That falls on the shoulders of President Bush's administration as well as this one. I am proud of her that she got it out. But the fact is, 11 years to do what you are responsible for, to get an egg standard so we do not have significant salmonella poisoning coming from eggs? Then, lo and behold, after the egg standard is out, the FDA inspectors on farms in Iowa are violating their own protocols, cross-contaminating egg farms, as documented in the press.

It is not a matter that we do not have enough rules and regulations. That is borne out by the fact that we are continually seeing a decline in foodborne illness. That is not the real problem. The problem is effectively carrying out the regulations that are there today. So we have a bill on the floor that has 150 to 170 pages--I cannot recall exactly how many it is--here it is. It is 266 pages of new regulations, new rules, new requirements.

Let me tell you something else I learned about dealing with the FDA. The FDA overall in this country does a fantastic job. They do. They are very professional. They are very slow sometimes, but they are very professional, and they are very cautious. In this bill is a mandate to require recalls. Not once in our history have we had to force anybody to do a recall. It has always been voluntary, and you can check with the FDA on that. They do not need that authority. Why don't they need that authority? Because if you have a problem with your product in the food system in this country, you are going to get sued. You are going to get fined if you do not recall that product.

What is wrong with a potential mandatory recall? What is wrong is it is going to markedly raise the cost of foods. Let me explain why. It is called Coburn's bureaucratic principle: Do what is safe first in the bureaucracy rather than what is best.

Here is what I imagine happening with a mandatory recall. Because we have a problem, we are going to recall something and we are going to force a mandatory recall. Even though they may recall it voluntarily, somebody is going to pull the trigger earlier, because they don't want any criticism. There is a great example for that. How many people remember the toxigenic E. coli jalapeno pepper episode? Voluntary recall for tomatoes, because we said it had to be in the tomatoes, so they did that. That cost $100 million to the tomato farmers in this country and didn't save one life, because they got it wrong. They discovered about 10 days after that, it wasn't the tomatoes, but the damage was already done. I can remember I ordered my hamburger in my special place in Muskogee, My Place BBQ, and I couldn't get a tomato on it. The reason we couldn't get a tomato--there wasn't anything wrong with tomatoes in this country; it was because a recall had been suggested by the FDA and the tomato growers responded.

So what we are going to see is a heavy hand rather than a working, coordinated foundation upon which we do recalls, as we do now. We have not had one instance ever when a food needed to be recalled that wasn't voluntarily recalled.

What I worry about is the fact that we will have recalls that are mandated much too soon on the wrong products at the wrong time. We don't have a track record that says the government needs additional power. As a matter of fact, the FDA doesn't say they need additional power.

So let's summarize for a minute. Where is the crisis in food safety, when the science demonstrates that we have the safest food in the world and we are on a trendline to have it even safer? Where is the cost-benefit analysis in terms of what we are going to get from spending another $1.5 billion in terms of lowering that number? There is nothing in this bill to show that. What is in this bill are tremendous new sets of regulations and authorities on top of the authorities that both the CDC, FDA, and Department of Agriculture already have, that I don't believe--and I agree I am in the minority on that, but I am trained in the area of medicine, science, and epidemiology--I don't believe we are going to get a significant cost-benefit from it.

We are going to feel better because we did something. But, again, that goes back to the first three principles. If we don't treat the underlying problem--in other words, have the oversight hearings to make sure the agencies are actually carrying out their functions every day on a thorough basis that can be vetted and making sure we are doing the right things to create the opportunities to have safe food--we are not accomplishing anything, but we are going to feel better. But do we know who is going to feel worse? Our kids. Because they are going to pay--if we appropriate this money, and I highly doubt a good portion of it will be appropriated--they are going to pay for it. If you followed last week in international finance, the scare over Ireland's ability to repay its debt, and the pressure it had--and we got good news on the economic front today--good news, and it is welcome news by all of us. But the fact is, what is happening in Ireland and in Greece and Spain and Portugal is getting ready to happen to us. And this is a small example of why--very good-intentioned, well-intentioned people trying to do the right thing, fixing the symptoms instead of the underlying problem.

Our answer is more regulation has to be the answer. That is what we did in the financial regulation bill. That is what we did to the SEC after Bernie Madoff. Everybody knows the SEC was alerted several times, but they didn't do their job. Consequently, we put all of these new rules and regulations to not let another Bernie Madoff scandal happen when we should have been holding people accountable for not doing their jobs.

I am not against regulation, but I think it ought to be smart, targeted, and focused to real problems, not the symptoms of the problems. It is my personal belief--that we are targeting symptoms and not the real problems with this bill.

Senator Harkin has bent over backward to work with me. He is an honorable man. He is interested in food safety and the welfare of this Nation. Nobody should ever say otherwise. But my experience leads me to believe it isn't going to accomplish the very purpose he wants to accomplish, and my recommendation is to go back and work in the new Congress to develop a true food safety center organization within the Federal Government that combines all the factors.

Do my colleagues realize right now when we buy a pizza at the grocery store, if you buy a cheese pizza it comes through the FDA, but if you buy a pepperoni pizza, it gets approved by the U.S. Department of Agriculture? How many people in America think that makes sense?

The other thing with this bill--and I will finish with this and then yield the floor--is this bill wants more inspections. That is great. There is no question that inspections will help; the question is what is the return on the dollars we spend for it. But if we are going to use more inspections, there is not nearly enough money in this bill to do it effectively. That is what we are going to trust.

Let me tell my colleagues why I think we have the safest food in the world: because we have the best legal system in the world. That is why we have the safest food, because the market forces applied on somebody selling food into our commerce are so great and the consequences legally are so negative that it is only in their best interests to bring a safe product to the market. When we have food scares, most of the time it is not an intentional act that created the problem, it is an unintentional act. It is a failure of someone in carrying out a protocol that should be established.

Under this bill, anybody who sells more than $500,000 worth of food--that is almost every Amish farmer in America--a co-op of Amish at every farm--will have to have a detailed, laid-out plan, written down, double checked, cross checked and everything else. What do my colleagues think that is going to do to the cost of food? Do my colleagues think as we implement new regulations, those costs aren't going to be passed on? So as we grow the government, if, in fact, we are treating symptoms and not underlying problems--and I don't have any problems with regulations that address real problems--all we are doing is raising the costs and making ourselves less competitive, decreasing the number of jobs that are available in this country, and not truly ensuring an increased level of safety with our food supply.

It is hard to dispute the facts about our incidence of foodborne illness. One case is too many. But we don't have the resources to make it where there is not one case, even. It is the same question on homeland security. Can we ever spend enough money to 100 percent guarantee that we won't have another terrorist attack? Anybody who looks at it says no, we can't do that. It is the same with food. For every additional dollar expended, what is the return to the American consumer for that?

If it were an achievable goal to eliminate all foodborne illness, I would be right there with you. It is not achievable. It is going to happen. The question is: Can we continue on a slope to continue to decrease the frequency where we have the least amount for the dollars we spend? There is a balance, and we need to be there. I will take the criticism of my colleagues that they think we need to spend this additional $1.5 billion to get it further down the road. But I still raise the question of how we cut it in half over the last 9 years--or 5 years--and didn't spend anything. So we are on a good trend.

We are, unfortunately, going to have complications with our food supply, but we have a great legal system where we have bad actors such as the peanut butter factory in Georgia which is now shut down, in bankruptcy, and people are going to jail, because they intentionally violated the rules we have today. But how did they intentionally do it? Because we didn't have effective carrying out of the regulations we have today.

I appreciate the great manner in which Senator Enzi and Senator Harkin have worked with me. I have another amendment I wish to offer on this bill. Everybody knows what it is. It is an earmark amendment. I understand the disdain for having to vote on that and I understand the procedural moves that will be made for that, but we are going to vote on it. We are going to suspend the rules to get the first vote, but I can assure you in the next Congress we are going to get an up-or-down vote on it, and it is going to pass in this body because the American people expect it to pass. It is something we ought to put away until we get out of the problems we are in nationally.

I yield the floor and note the absence of a quorum.


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