REGULATION OF DIETHYLSTILBESTROL (DES), 1972

THURSDAY, JULY 20, 1972

U.S. SENATE,

SUBCOMMITTEE ON HEALTH,

COMMITTEE ON LABOR AND PUBLIC WELFARE,

Washington, D.C.

The subcommittee met, pursuant to notice, at 9:40 a.m., in room. 4232, New Senate Office Building, Senator Edward M. Kennedy (chairman of the subcommittee), presiding.

Present: Senators Kennedy and Javits.

Committee staff present: LeRoy G. Goldman, professional staff member; Dr. Larry Horowitz, professional staff member; and Jay B. Cutler, minority counsel.

Senator KENNEDY. The subcommittee will come to order.

Diethylstilbestrol-DES-is a synthetic estrogen which is widely used in beef cattle and sheep to stimulate more rapid weight gain with less feed.

DES is also, however, a well-recognized carcinogen and has been directly linked to the appearance of vaginal cancer in young women whose mothers had taken large doses of DES during their pregnancy. At significantly lower doses, DES causes cancer in mice.

These two sets of facts present a classic policy dilemma-under what conditions can an economically useful agent, which has some potential to do grave harm to human beings, in this case by causing cancer, be used in the food industry?

The Congress has considered this dilemma in the past, and with administration concurrence, has resolved it very clearly.

The Delaney clause of the Food, Drug, and Cosmetic Act forbids the appearance of any residues of known cancer-causing agents in the food people eat.

That fact is not in dispute. The law does not require that cattle, for example, not be fed cancer-causing agents. But it does require that all such agents be completely eliminated from those cattle by the time they are slaughtered and sent to market.

The intent of Congress here is clear-whether by banning such substances or by assuring their disappearance before slaughter, cancercausing agents must not be found in the meat that appears on America's dinner tables.

We are here today because DES, a known cancer-causing agent, is appearing on thousands of American dinner tables. It appears four times more frequently today than it did 6 months ago. The latest figures released by the Department of Agriculture this past Tuesday show that 2.27 percent of all cattle tested contained DES residues after slaughter. Considering that we slaughter in excess of 30 million

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cattle each year, that means that more than 660,000 head of cattle probably reach American dinner tables, in various forms, with a known cancer-causing agent in them.

The Food and Drug Administration is the regulatory body which is responsible for controlling DES. Six months ago, when the reported incidence of DES was 0.5 percent, FDA took the position that the residues could be eliminated by tightening administrative procedures. They did just that, extending the period for withdrawal of cattle from DES to 7 days from the previous 2-day period. At that time, FDA Commissioner Charles C. Edwards stated:

The FDA will not permit DES residues in the food supply. Should the new con trol procedures prove unsuccessful in application-we are prepared to ban its use entirely from animal feeds.

There was considerable controversy 6 months ago about whether the new control procedures could be successful. Dr. Roy Hertz, senior physician at the Rockefeller University, formerly of the National Cancer Institute, said:

I think that administratively, this would be totally impractical. I think the hazards of additional exposure would be increased by such a practice rather than reduced, and I believe that on the face of it, knowing regulatory practices, par ticularly on a national scale, notwithstanding the possibility of criminal action against violations, that the impracticability of protecting the public from exposure to these materials in foodstuffs is very, very great and really a foolhardy under taking. What has been proposed by *** FDA is unfeasible and impractical and ill-advised.

It now seems that the control procedures are unenforceable. In 6 months, the incidence of DES has risen from 0.5 to 2.27 percent. And yet, DES is, at the present moment, still not banned and still is part of many Americans' daily diet.

FDA has called for public hearings to "gather all the facts" in this matter. To do that, it has explained that the only mechanism available is to propose a formal action to withdraw approval of the drug which would automatically, in their words, "*** bring about an opportunity for an official hearing." Such hearings have in the past, however, been far from automatic-on March 31, 1971, 15% months ago, FDA published a similar hearing notice for Nihydrazone and there has still been no hearing.

The facts in this case are clear. So clear that 21 countries, including the two leading cattle producers, Argentina and Australia, have banned DES; and Sweden and Italy have banned the importation of U.S. meat from cattle fed with DES.

The law is also clear. What is not clear is why the FDA has not fol lowed the friendly advice of Dr. Frank L. Rauscher, the Director of the National Cancer Institute, who has said he would ban the use of DES in cattle feed now, and then, if warranted, conduct hearings. My distinguished colleague, Senator William Proxmire of Wisconsin, is the principal sponsor of S. 2818, which would bar DES from use in animal feed. At this point we will enter a copy of the bill, S. 2818. (A copy of S. 2818 follows:)

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92D CONGRESS
1ST SESSION

S. 2818

IN THE SENATE OF THE UNITED STATES

NOVEMBER 8, 1971

Mr. PROXMIRE (for himself, Mr. BAYH, Mr. CASE, Mr. McGOVERN, Mr. Moss, and Mr. RIBICOFF) introduced the following bill; which was read twice. and referred to the Committee on Labor and Public Welfare

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to prohibit the administration of the drug diethylstilbestrol (DES) to any animal intended for use as food, and for other purposes. 1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 3 That section 301 of the Federal Food, Drug, and Cosmetic 4 Act (21 U.S.C. 331) is amended by adding at the end 5 thereof a new subsection as follows:

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"(q) The administering of the drug diethylstilbestrol 7 (commonly known as DES) to any animal intended for

8 use as food or to any animal the product of which is intended 9 for use as food."

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1 SEC. 2. Section 409 (a) of the Federal Food, Drug, and 2 Cosmetic Act (21 U.S.C. 348 (a)) is amended by inserting 3 "(1)" immediately after "SEC. 409. (a)"; by redesignating 4 clauses (1) and (2) as clauses (A) and (B), respectively; 5 and by adding at the end of such section a new paragraph 6 (2) as follows:

7 “(2) A food shall be deemed to be unsafe for the pur8 poses of the application of clause (2) (C) of section 402 (a) 9 if it contains the drug diethylstilbestrol (commonly known 10 as DES)."

Senator KENNEDY. This morning's hearing will consider the impli ations of S. 2818 and the entire DES question.

Senator Javits.

Senator JAVITS. Thank you, Mr. Chairman.

First I would like to state my support of the chairman in calling these hearings and my gratification for his having agreed to have as the opening witness FDA Commissioner Edwards who will express his views, which I understand are to be that DES is safe if used as directed and, as to the question of "imminent hazard" and whether the evidence is adequate to support that legal requirement.

For myself, I believe, with my colleagues, that if DES residues cannot be eliminated-and that seems to be the evidence of the Department of Agriculture-then we have to prohibit the introduction of DES into the food supply, unless we are shown some very good reason why not;

I am very gratified, Mr. Chairman, that we are having these hearings, and we will get right down to business on the practicalities of the situation.

Mr. Chairman, I would like at this moment to express my appreciation for the appearance here of a top scientific witness, Dr. Peter Greenwald, director of the Cancer Control Bureau of the New York State Department of Health.

His tremendous background, training, and experience concerning this issue, and his investigations relating to the possible cause-andeffect relationship between DES administered to pregnant women and cancer of the vagina, to which the chairman referred, occurring years later in their daughters.

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This will be discussed with us, and I am sure will have a great bearing on how we handle this matter in the future.

I want to mention also my appreciation for the appearance of Dr. Rauscher of the National Cancer Institute, who has shown a remarkable sensitivity to the need to deal with this issue in a most decisive way.

(The prepared statement of Senator Javits follows:)

PREPARED STATEMENT OF HON. JACOB K. JAVITS, A U.S. SENATOR FROM THE STATE OF NEW YORK

Mr. Chairman, it is a matter of great scientific importance and serious social implication as to whether we should ban the use of diethylstilbestrol-commonly known as DES-a synthetic drug. While DES promotes rapid weight gain in beef cattle with its cost savings and better quality meat for the consumer, it has been determined to be a carcinogen capable of causing cancer in experimental animals and is also reportedly linked to human cancer.

Dr. Frank J. Rauscher, Jr., the Director of the National Cancer Institute, which has as its mission the conquest of cancer, recently indicated that the prudent course is to prohibit DES in livestock feed pending the outcome of the FDA public hearings on the matter.

Dr. Rauscher has publicly defined his mission as Director of the National Cancer Institute as being "to protect the people from cancer." I believe our commitment as legislators is to help him fulfill that goal. If legislatively reasonably possible, we should eliminate from the environment anything that increases man's carcinogenic burden.

Apparently the FDA voluntary regulatory control programwithdrawal of DES from livestock feed for greater periods prior to slaughter, for example, from 48 hours to 7 days-has not been successful; the DES detection rate has increased. I understand FDA Commissioner Edwards views DES safe if used as directed and at this point does not believe there is sufficient evidence to declare it an "imminent hazard" which would enable the Secretary to ban the use of DES pending the outcome of the FDA hearings. However, I believe that if DES residues cannot be eliminated-and that appears likely according to the evidence found by recent Agriculture Department samplings of beef and lamb livers-then we would have to prohibit the introduction of DES into the food supply.

In closing, Mr. Chairman, I am pleased to welcome as a witness Dr. Peter Greenwald, director of the Cancer Control Bureau of the New York State Department of Health. Dr. Greenwald has an outstanding background of training and experience concerning this issue and has investigated the possible cause-and-effect relationship between DES administered to pregnant women and cancer of the vagina occurring years later in their daughters.

Senator KENNEDY. I want to welcome this morning as our first witness Senator Proxmire, who is perhaps best known for his very effective work as Chairman of the Joint Economic Committee.

He introduced this legislation a number of months ago. I believe it was on November 8 of 1971, so he was very much aware of this problem and concerned about it a long time go, before it was really brought forth for a full airing.