Prescription Drug User Fee Amendments of 2007

Floor Speech

PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 -- (Senate - May 02, 2007)

BREAK IN TRANSCRIPT

AMENDMENT NO. 1022
(Purpose: To ensure the safety of human and pet food.)

Mr. DURBIN. Mr. President, in a brief period of time I will be offering an amendment which I hope to bring to a vote very shortly, perhaps in the next 15 or 20 minutes, depending on the wishes of the chairman of the committee and the ranking member, Senator Enzi.

This amendment relates to the issue of food safety. This has been one of my concerns for a long time as a Member of the House and the Senate. I know everyone across America trusts that the food they buy for their families and everyone in their house is safe, that they can eat it and not get sick.

We all know what has happened over the last several months. Whether we are talking about contaminated E. coli in spinach, salmonella in peanut butter, or the latest pet food contamination, people are asking questions of Members of Congress and this Government: Are we doing our job? What is happening here? Why are so many dangerous food products showing up so frequently? How can we protect ourselves?

For many years I have thought the real answer is to tackle the whole issue. I have said it before on the floor, 12 to 15 different Federal agencies inspect our food--imagine that--and they all have different standards. Some inspect food every single day. Go to a meatpacking plant, poultry processing plant; the food is inspected every single day, every minute of every day, as it passes along those lines by the U.S. Department of Agriculture.

Fish is another story. Fish is inspected by the Food and Drug Administration. How do they inspect it? By

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what they call the ``sniff test.'' They lean over and smell the fish, and if they have what they call a ``head snap,'' they know they have a bad load of fish. Sounds kind of comical, but it is what we get down to, by and large, in terms of inspecting fish.

So when you go throughout our Government and look at different products and how they are inspected, it makes no sense why different agencies are doing different parts of the food chain. From a consumer's point of view, I do not want to know there are 12 or 15 different agencies at work, with their lights on, in Washington, with a lot of different employees. I want to know there is one good agency, scientifically driven, that is making the right call as to whether there should be an inspection every day, every month, every year--whenever.

They do not have that today, and the system breaks down. What we have seen happen over the last several months is a clear indication that our food safety system--as good as it may be--needs to be a lot better. So I am offering this amendment on food safety.

I thank the Senator from Wyoming who has been very cooperative and helpful in making certain this is a bipartisan amendment. There is nothing partisan about food safety. We should all agree that the goal is one both parties share, all Americans share. Senator Kennedy has given me the time to offer this amendment on this important bill early on, and I certainly appreciate it. Senator Allard from Colorado, a veterinarian, has been involved in this negotiation, as has Senator Harkin, the chairman of the Agriculture Committee. Many people have come together to take a look at this and make sure it is moving in the right direction.

There was an early warning. The early warning came a few weeks ago when we had a pet food crisis. People who own dogs and cats know what I am talking about. All of a sudden there was a suspicion that the food you were giving your dog--that animal you love, an animal that is part of your family--could be poisoning that animal. Well, for 90 million Americans that is a big deal, and they were concerned about it. So we started looking into why this pet food was contaminated.

That crisis was an early warning signal to America. It was a warning signal that we came to learn had a lot to do with the imports coming into America. More and more imports of food products are coming in from overseas. If you believe we have inspectors sitting in China and France and Germany and Brazil taking a look at these things as they come off the assembly line, taking a little test sample and running it to the lab, you are wrong. It does not happen. In fact, once the shipment is on the boat, or on the plane, coming to America, the odds are 99 to 1 no inspector will ever look at it before it is put into a food product--99 to 1. Only 1 to 1.5 percent of food products sent to America is actually inspected by our Government.

Now, we look at what came over from the Chinese and find out they were adding a chemical to wheat gluten, a protein product called melamine. Melamine is a chemical derived from coal, which is used in the manufacturing of plastic. It has no business in anything that is edible. It was put into the shipment of protein, this wheat gluten, in order to enhance its value because when they tested this wheat gluten on its arrival, this melamine chemical indicated the presence of nitrogen, therefore, more protein, and, therefore, it was worth more.

They would sprinkle in the melamine and make more money off the shipment. If this were the end of the story, you would say: Well, that was a pretty nice move; they just made a bigger profit off the shipment. It wasn't the end of the story. It turns out that wheat gluten, when used for pet foods, is toxic. Over 4,000 animals died across America because of melamine and possibly other contaminants. We are still investigating.

So we went to find out how it got into the shipment, and the Chinese did not cooperate. They have started to. I am glad they have. They have agreed to visas for our inspectors. But this pet food crisis was a warning sign, a signal to us in America that this dramatic increase in imports of food products leaves us vulnerable. Today, it was your cat or your dog. Tomorrow, it could be someone in your family whom you love. So we address part of this in this bill.

Secondly, it is an indication that the Food and Drug Administration doesn't have the authority or the resources to do their job as well as they should. This is a great agency. They have an awesome responsibility. We heap more and more responsibility on them each year, we provide them very little by way of additional resources, and they are being stretched to the absolute limit. Of course, this pet food crisis is an early warning that the whole food safety system has to be investigated and honestly looked at. So this is a start. It is an effort to try to make a difference.

I wish to thank Senator Kohl from Wisconsin and Senator Bennett from Utah. When the pet food crisis came out, they called a timely hearing after our Easter recess, and we started working on this amendment just at that moment, and thanks to them for realizing the importance of this issue.

I also thank those who helped us draft this legislation--the Center for Science and the Public Interest, the Humane Society, which has been terrific from start to finish, the American Veterinary Medical Association, and the Coalition for a Stronger FDA.

Special thanks, while I am giving out bouquets here, to my staffer David Lazarus. This young staffer has really put his heart and soul into this effort. It is his first major legislative undertaking, and I commend him for the very fine job he has done.

Let me say very briefly what this amendment will do. First, it deals with pet food because we have just come off of a pet food crisis, but it doesn't stop there because this contamination doesn't stop with pet food. Sure, we found it in the cans of dog food and cat food, but guess what. It ended up in livestock feed. It ended up moving into the feedlots for hogs, turning into pork products we buy in the store. It ended up in poultry plants, being fed to chickens. We are naive to believe that any problem in the pet food industry can't possibly make it to the human food side of the equation. It can. God forbid that it ever does. We hope we have stopped it in this instance, but it is pure luck if we were able to save ourselves from that calamity this time. We don't want it to happen again.

There are provisions in this amendment which go directly to the pet food issue, provisions which require the FDA to update their labeling standards for pet food, including nutritional and ingredient information, working closely with the American Association of Feed Control so that the representations on the labels of these cans of pet food are honest representations about what is good for your animal and what is safe. Also, it requires that the Secretary of Health and Human Services establish an enhanced system capable of detecting food contamination and outbreaks of pet illness and death.

This amendment also requires the FDA to develop an efficient, effective communication plan to coordinate with veterinarians and consumers, owners across America, so that we can find out if we are dealing with a need for a recall. Recall data would be consolidated and presented in a searchable format. They were recalling pet food so quickly that if you went to the FDA Web site, you had to plow through all of the corporate press releases to figure out just exactly what was a dangerous product. When I mentioned this to the FDA, they changed their Web site, and we put it into law, to make sure they are consumer friendly and have up-to-date information consumers can understand.

We work with the Secretary as well and the States on activities and programs to improve the safety of raw agricultural commodities. We go beyond just pet food into all edible products, agricultural products. What we attempt to do is to have the Secretary share resources with the States to improve State food programs and help States establish standards for inspection. Fifty States, 50 standards, is unacceptable. There should be one scientific matrix we follow so we know that whether the product comes from Oregon or Illinois or New Hampshire, that it is safe.

We also establish something that I think is historic. It applies to pet and human food as well. It is an adulterated food register, to collect information on cases of food adulteration and suspected adulteration that are potentially dangerous and improve the speed

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by which consumers learn about them. We want an early-warning system, and in this age of computers and the Internet, we can achieve it.

I believe this is critically important. In this case, there was a Canadian company called Menu which made dog food. Menu discovered in the middle of February that the cats and dogs were turning up their noses at their product, and then they found those that were eating their products started to show signs of illness, and then some of the animals died. Do you know how long it took them to report this to the Food and Drug Administration? Three weeks. Three weeks, while their products spread across Canada and North America, on the shelves of stores, and unsuspecting customers were buying them, they weren't reporting them. Our law now requires reporting within 2 days, and if they fail to report, they face civil penalties, which I hope will be imposed on a timely basis so that we let all companies know this kind of delay is intolerable.

We also do something here that is important. If we find evidence of adulterated food, we report it as well to Homeland Security. Why? Well, Governor Tommy Thompson told us why. When he left as Secretary of Health and Human Services under this administration, he said: I find it unimaginable that someone hasn't tried to use our food supply--the terrorists haven't turned to our food supply to cause injury and death. He understood, as I do, and everyone should at this moment, it is a vulnerability for America we need to avoid. So this food registry will move us into a notification phase so the Department of

Homeland Security can at least have notice if there is a problem.

We also require better access to business records for the investigation to get to the bottom of it. Where did it come from? How is it used? How can we contain the need?

We talk about a sense of the Senate in this amendment that points in another direction, maybe going beyond this current crisis into looking at an overhaul of our whole food safety system, and we require the Secretary of Health and Human Services to report annually to Congress with information about their inspections and enforcement.

I am going to yield the floor at this point, and I again thank Senators Kennedy and Enzi for their help on this important legislation.

I wish to tell my colleagues that there were things I wanted to add in with this amendment, but in the interest of avoiding political conflict and in the interest of not slowing down this important legislation and in the interest of making certain we did achieve something today, I am saving those arguments for another day.

One of them is the issue of mandatory recall, which I think our Government should have the power to do and currently does not. Our Government and its agencies do not have the power to recall contaminated food from the shelves. I believe that law needs to be changed. It is not included in this amendment. We will save that debate for another day.

Again, my thanks to my colleagues.

Madam President, I ask unanimous consent that the pending amendment be set aside, and I send an amendment to the desk and ask for its immediate consideration.

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