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COMMITTEE ON LABOR AND PUBLIC WELFARE

HARRISON A. WILLIAMS, JR., New Jersey, Chairman

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CONTENTS

S. 2818, text of____

THURSDAY, JULY 20, 1972

Proxmire, Hon. William, a U.S. Senator from the State of Wisconsin,
accompanied by Tom Van Der Voort and David Epstein__
Edwards, Charles C., M.D., Commissioner, Food and Drug_Adminis-
tration; accompanied by Dr. Henry Simmons, Director, Bureau_of
Drugs; Peter Hutt, Assistant General Counsel, Food, Drugs, and En-
vironmental Health Division; Dr. C. D. Van Houweling and Gerald F.
Meyer, Director, Office of Legislative Services, Food and Drug Admin-
istration_

Greenwald, Peter, M.D., Director of the Cancer Control Bureau, New
York State Department of Health_.

Herbst, Arthur L., M.D., assistant professor of obstetrics and gynecology,
Massachusetts General Hospital, Harvard Medical School, Boston,
Mass

Rauscher, Dr. Frank J., Jr., Director, National Cancer Institute, National
Institutes of Health..

Flack, Dr. Duane, D.V.M., chairman, Task Force Committee, DES,
American National Cattle Association___

STATEMENTS

American National Cattlemen's Association, prepared statement..
Edwards, Charles C., M.D., Commissioner, Food and Drug Administra-
tion; accompanied by Dr. Henry Simmons, Director, Bureau of Drugs;
Peter Hutt, Assistant General Counsel, Food, Drugs, and Environ-
mental Health Division; Dr. C. D. Van Houweling and Gerald F.
Meyer, Director, Office of Legislative Services, Food and Drug Ad-
ministration__

Flack, Dr. Duane, D.V.M., chairman, Task Force Committee, DES,
American National Cattle Association....

Prepared statement..

Greenwald, Peter, M.D., Director of the Cancer Control Bureau, New
York State Department of Health.

Herbst, Arthur L., M.D., assistant professor of obstetrics and gynecology,
Massachusetts General Hospital, Harvard Medical School, Boston,
Mass..

Javits, Hon. Jacob K., a U.S. Senator from the State of New York, pre-
pared statement__.

Kaler, James L., counsel for Vineland Laboratories, Inc., Vineland, N.J.
Proxmire, Hon. William, a U.S. Senator from the State of Wisconsin,
accompanied by Tom Van Der Voort and David Epstein-

Rauscher, Dr. Frank J., Jr., Director, National Cancer Institute, National
Institutes of Health...

Prepared statement..

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(III)

ADDITIONAL INFORMATION

Articles, publications, etc.:
"Diethylstilbestrol: Notice of Opportunity for Hearing on Proposal
to Withdraw Approval of New Animal Drug Applications," Elanco
Products Co., et al., (Docket No. FDC-D-494; NADAS 9525,
etc.), Food and Drug Administration, Department of Health,
Education, and Welfare; from the Federal Register, vol. 37, No.
120 Wednesday, June 21, 1972----.

Documents on DES (submitted by Senator Proxmire):

Livers-Feed surplus...

Hormones present in the human body.
Explanation of statistics___.

FDA memorandum: from Leo Friedman, Ph.D., Director, Di-
vision of Toxicology, To Dr. Virgil Wodicka, Director, Bureau
of Foods, February 8, 1972__

Communications to:
Kennedy, Edward M., a U.S. Senator from the State of Massachu-
setts, chairman, Subcommittee on Health of the Committee on
Labor and Public Welfare, from:

Hutt, Peter Barton, Assistant General Counsel, Food, Drugs, and
Product Safety Division, Department of Health, Education,
and Welfare, Rockville, Md., October 3, 1972...
Masterson, Carlin G., Consumer Action Now, New York, N. Y.,
July 21, 1972.

Fountain, Hon. L. H., a Representative in Congress from the State
of North Carolina, from Kenneth M. McEnroe, Acting Associate
Administrator, Meat and Poultry Inspection Program, Animal and
Plant Health Inspection Service, U.S. Department of Agriculture,
Washington, D.C., July 11, 1972 (with enclosures)...

Selected table:

Table 1. Vaginal Cancer and Maternal Use of Synthetic Estrogen in Patients Reported in the New York State Cancer Registry, 1950-1972__

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REGULATION OF DIETHYLSTILBESTROL (DES), 1972

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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

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 DEŠ 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 control 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, particularly 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 undertaking. 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 followed 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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