REGULATION OF DIETHYLSTILBESTROL

(DES), 1972

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON

LABOR AND PUBLIC WELFARE
UNITED STATES SENATE

NINETY-SECOND CONGRESS

SECOND SESSION

ON

S. 2818

TO AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
TO PROHIBIT THE ADMINISTRATION OF THE DRUG DIETHYL-
STILBESTROL (DES) TO ANY ANIMAL INTENDED FOR USE AS
FOOD, AND FOR OTHER PURPOSES

COMMITTEE ON LABOR AND PUBLIC WELFARE

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

S. 2818, text of...

CONTENTS

Page

3

THURSDAY, JULY 20, 1972

Adminis

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
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..

(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.