STATEMENT OF HON. WILLIAM PROXMIRE, A U.S. SENATOR FROM THE STATE OF WISCONSIN, ACCOMPANIED BY TOM VAN DER VOORT AND DAVID EPSTEIN

Senator PROXMIRE. Thank you, Mr. Chairman.

I have with me Tom van der Voort and David Epstein of my staff. Let me first thank you very much for you and your Subcommittee on Health convening these hearings; and I see that you and Senator Javits have both anticipated part of what I intend to say this morning, and I appreciate that very much.

Congress must devote serious attention to a cancer-causing drug which has shown up in the food supply of the American people with alarming frequency in recent months.

My reading of the record indicates that Congress has, on numerous occasions in the past, devoted its serious attention to this very issue, and has already resolved it through the Delaney amendment.

According to that provision, no residue-producing carcinogens may be added to American food supplies. But for whatever reasons, the FDA has not seen fit to apply the Delaney amendment to DES.

Accordingly, I have proposed specific legislation on that subject. To my knowledge, no one expresses the slightest doubt that DES is carcinogenic. An expert from the National Cancer Institute told Congressman Fountain's Intergovernmental Relations Subcommittee that DES is "one of the chapters in a textbook" on cancer.

Laboratory experiments have proven it to be carcinogenic to animals. And a 1970 study established a clear link between use of DES by pregnant women and vaginal cancer in their daughters.

Yet, DES is currently being added to livestock feed to increase the growth rates of cattle and sheep.

To the best of my knowledge, more than half of our beef is being fed DES.

Residues of DES have been detected in beef and lamb tissue samples tested by the Department of Agriculture since 1965. As of last December, residues were being found in about one-half of 1 percent of samples tested.

At that time, the Food and Drug Administration claimed that these residues were attributable only to violations of the procedural guidelines set down for use of DES.

Therefore, the agency made their guidelines mandatory, lengthened the period for withdrawal of livestock from DES-medicated feed from 2 to 7 days, and promised stricter enforcement.

At that time, the FDA was confident that this would solve the problem of the persistent one-half of 1 percent residue rate. But FDA Commissioner Edwards repeatedly assured Congressman Fountain's House Subcommittee about FDA's intentions if the new controls failed.

On page 203 of the hearing record, he said:

Should the new control procedures prove unsuccessful in application, or should new evidence on DES be developed, we are prepared to ban its use entirely from animal feeds.

And on page 251:

The fact of the matter is, if we find that our new program is not working, there is just one recourse for us and that is to ban its use totally.

The new procedures went into effect January 1. What has happened since that time?

From the beginning of January to the middle of April, the residues continued at about one-half of 1 percent. But between April 15 and the most recent report on July 8, the residues showed up at a startling average rate of 3.60 percent. That is over seven times higher than the old figure.

If that rate continued for a year, it would mean over 1,200,000 cattle would be slaughtered in this country with residues of DES. This rate, I remind you, is with the new FDA procedures in effect. I do not believe anyone would deny that these controls are, to use the Commissioner's phrase, "unsuccessful in application."

As it happens, April 15 was the date that the USDA began reporting results of more sensitive tests which detect DES levels below two parts per million. So part of the increase is attributable to improved detection-but only part of the increase.

To be precise, 2.06 percent of the samples showed residues under two parts per million; and the other 1.54 percent showed residues over two parts per million.

This means two things: first, the lower level residues were presumably present before April. So there were in the past more residues than we had known about.

Second, the residues above two parts per million have themselves tripled; which means that regardless of measuring techniques, the absolute number of DES residues seems to have increased markedly. Neither of those conclusions is at all comforting.

With a 7-year history of residues, why hasn't the FDA banned DES under the Delaney clause?

The answer they gave last winter was to insist that there is in theory no reason for there to be residues. The FDA said its experiments persuaded it that DES, used in accordance with the regulations, leaves no residue. Therefore, even though there was no evidence of procedural violations in a number of the cases the FDA reported to the House subcommittee, they argued that if there were residues, there must have been procedural violations.

If the problem is indeed one of enforcement, it is no less a problem. I understand that at the present time, the FDA has filed one court case and has two more in process. There have been 54 residues reported since January. This subcommittee should find out what has happened in each of those cases.

If FDA thinks the regulations can be enforced, why are not violators prosecuted?

But frankly, I will not be satisfied if FDA manages to bring a few more cases to trial. The purpose of controlling DES is to protect American consumers; and even a more vigorous prosecution program will not achieve this. The primary grounds for prosecution rests on finding DES residues.

The USDA inspection program for DES tests about one out of every 10,000 cattle slaughtered each year. That is apparently enough to give us an idea of how widespread DES residues are.

But that also means that the chance of an individual violation being detected and prosecuted is extremely small.

Many violations are apparently unintentional, resulting from crosscontamination of feed supplies, human error, or animals uncooperatively eating feed intended for other animals. Even under laboratory conditions, according to the testimony of Dr. Roy Hertz, it is difficult to prevent accidental contamination with an agent as potent as DES. Unintentional violations, in all but the tiniest fraction of cases, will not even be called to the farmer's attention. And there is certainly no particular incentive to scrupulously follow the regulations. The point is that such a plan of controls is simply unworkable. It will continue to detect the presence of residues in our food, but it will do almost nothing to stop the residues.

It is not enough for the FDA to assert that their procedure should prevent all residues. It cannot comfort Americans to know that their meat is uncontaminated in theory, while it, in fact, may contain carcinogenic residues.

Whether the FDA regulations are inadequate, or whether they are adequate but violated-in either case, the result is residues of a carcinogen in livestock destined for American dinner tables. In either case, it is unacceptable. In either case, the solution is a ban on the use of DES.

Some who have opposed a ban on DES have managed to be quite equivocal in their assessment of its dangers. The FDA throughout last winter's hearings insisted that it agreed with the Delaney clause that no amount of carcinogenic residue in meat is tolerable.

But again and again they explained that, well, if there just happened to be a little bit that slipped through, it wouldn't be so intolerable. But experts agree that there is no level that can be called safe for a carcinogen-nor do we know how to go about establishing such a level.

For this reason, Congress has again and again resolved that no carcinogen may be added to our food supply. According to FDA internal staff memoranda, even our most advanced techniques do not have anything near the sensitivity required to detect significant levels of residue. In fact, in one memorandum, two top FDA scientists recommended that consideration be given to "withdrawing DES from use in medicated feed until such time that an analytical method sensitive to one part per trillion is developed."

The two largest beef producing nations outside the United StatesArgentina and Australia-have already banned the use of DESand you can imagine the economic price that this constitutes with respect to those nations that depend far more on beef than we do as far as their balance of trade is concerned-as have the Common Market nations.

I recently received a letter from a spokesman from Canada's National Farmer's Union, indicating that organization's advocacy of a ban in Canada.

I am fully aware of estimates claiming that a ban on DES would cost the American consumer an additional $3.85 a year. That is not a trivial amount, but it is not extravagant, either.

The total national cost is less than the Federal Government will

spend for the National Cancer Institute this year. It is a drop in the bucket of our gross national product.

This assessment of cost, I believe, also reflects a limitation of imagination. There should be an intensive effort to explore alternative

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means of cutting the costs of producing wholesome and I emphasize the word "wholesome"-meat. Getting our meat cheaply but with the potential of causing cancer is a bad bargain. By banning DES, we would provide the consumer with a bargain his dollars cannot now buy-the assurance that the beef and lamb he eats is uncontaminated by an artificial carcinogen.

Mr. Chairman, in great part owing to your leadership, our Nation has resolved to combat cancer. Surely controlling the hazards of carcinogens in our food supply is a necessary part of that effort. For 7 years, we have permitted residues of DES to reach the American consumer. We will not know the full impact on the health of our people for many years, if we will know then. But with the evidence about DES we already have, a ban on the use of this drug in livestock feeds is simply a matter of prudence.

Mr. Chairman, I addressed a beef producers' meeting in Wisconsin on this subject a few months ago. You can imagine that there was a natural concern about this and an opposition to banning DES on the part of the beef producers.

At that meeting, the Lilly Co., which is the largest present producer of DES, was represented; as was the Department of Agriculture of the State of Wisconsin, and the U.S. Department of Agriculture.

What I found was that the beef producers find themselves in a competitive situation. As long as DES is permitted, they are almost compelled to use it because they are in competition. If an individual beef raiser should not use it, his losses are considerable under these circumstances.

If it is banned, however, there is not any question that within a short time their collective situation will be ajdusted to the market, and their losses would not be significant; and I found that they understood that.

I talked to a number of them privately about this, and they told me if DES were found to be cancer producing, they certainly wanted it banned.

Senator KENNEDY. Thank you very much, Senator Proximre.

Your last comment is certainly very interesting. Your feeling then is that if the meat producers themselves were convinced that inclusion of DES in the feed would significantly threaten the health and well being of the American people, they would not want a part of it?

Senator PROXMIRE. Yes, indeed; but, as I say, they are in a position where they have to continue feeding DES because of the competitive situation.

Senator KENNEDY. Yes; but if it were banned and no one could use it, at least they could recognize the value of that step if they were convinced that it did pose a threat.

In the FDA release of June 16, they point out a beef animal will reach a market weight of about 1,000 pounds 35 days sooner using 500 pounds less feed than a comparable animal not fed DES.

That is in their Department press release. That seems to be to be an economic issue, not an FDA issue.

Senator PROXMIRE. That is true; but you also have a situation where this is not an economic problem for the country as a whole because we have a surplus of feed. In fact, we have a situation where we have to store it, take it off the market, in order to hold up the price.

Senator KENNEDY. I thought FDA was going to be looking at the health issues rather than the economic. It seems to me the Department of Agriculture would be making that argument rather than the Food and Drug Administration, which is charged with protecting the health and well-being of the people.

Tell me, what is your reaction to the Delaney amendment? Do you think that is strong enough? Do you agree with me that with the passage of the Delaney amendment by the Congress, the Congress thought it was doing the job that we want to be done in this circumstance; or do you think that it is full of loopholes?

Senator PROXMIRE. In this case, it seems to be a very clear loophole. It is obvious to me this is not being administered in the spirit in which Congress intended it, at least not in the spirit which this Senator intended.

There is not any question that DES is a carcinogen; there is not any question the purpose of the Delaney amendment was to prohibit or prevent meat or food containing carcinogens from being sold to the public, and they are being sold to the public.

Senator KENNEDY. I want to thank you again for your appearance here. You are a real leader in the Congress on this issue.

I think particularly that because you come from a meat-producing State, you have shown a considerable amount of courage on this issue, as well as on many others.

oppose

Senator PROXMIRE. May I add, Mr. Chairman, there are, I think, three issues which might arise on the part of those who this amendment, and I would like to leave the answers to some of the questions with you.

One claim is that DES residues are only apparent in livers. Since what we eat is mostly muscle tissue, why worry? Why not just ban the

livers?

I have some very interesting information indicating that DES residues are present in other parts of the animal.

Senator KENNEDY. Certainly if it is in the blood stream it would naturally contaminate the other parts of the animal.

Senator PROXMIRE. Yes, indeed; and we found when we got this more sensitive test it is at a somewhat lower level, one-quarter to oneninth of the concentration that is found in the liver, but is is found in the kidneys, the musculature.

A second claim is that DES produces more healthful meat because it reduces the amount of fat.

The answer there, I think, is a convincing answer, but as far as health is concerned, DES makes no contribution that is significant.

The third claim is that estrogenic hormones are naturally present in the human body as well as in many plants and animals which humans eat, and the answer is that natural hormones are vastly different from DES in level and potency.

I have this documented, and I would appreciate it if this information could be included in the record.

Senator KENNEDY. It will be included in the record. (The information referred to follows:)