DOCUMENT

DIVISION

INTERSTATE AND FOREIGN COMMERCE

HOUSE OF REPRESENTATIVES

EIGHTY-NINTH CONGRESS

SECOND SESSION

ON

H.R. 13884, H.R. 14634

BILLS TO PROTECT THE PUBLIC HEALTH BY AMENDING THE FEDERAL

FOOD, DRUG, AND COSMETIC ACT FOR THE PURPOSE OF STRENGTHEN-

ING AND FACILITATING MUTUAL COOPERATION AND ASSISTANCE, IN-

CLUDING TRAINING OF PERSONNEL, IN THE ADMINISTRATION AND

ENFORCEMENT OF THAT ACT AND OF STATE AND LOCAL LAWS RE-

LATING TO FOOD, DRUGS, DEVICES, OR COSMETICS, AND FOR OTHER

PURPOSES

H.R. 13886, H.R. 14557, H.R. 14632

BILLS TO PROTECT CHILDREN AND OTHERS FROM ACCIDENTAL DEATH

OR INJURY BY AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC

ACT WITH RESPECT TO ASPIRIN INTENDED FOR CHILDREN, SAFETY

CLOSURES ON DRUG CONTAINERS, AND CAUTIONARY LABELING OF

CONTAINERS OF ARTICLES SUBJECT TO THE ACT WHERE NECESSARY

TO THAT END, AND BY AMENDING THE FEDERAL HAZARDOUS SUB-

STANCES LABELING ACT TO BAN HAZARDOUS TOYS AND ARTICLES

INTENDED FOR CHILDREN, AND OTHER ARTICLES SO HAZARDOUS AS

TO BE DANGEROUS IN THE HOUSEHOLD REGARDLESS OF LABELING,

AND TO APPLY TO UNPACKAGED ARTICLES INTENDED FOR HOUSEHOLD

USE, AND FOR OTHER PURPOSES

JUNE 24; AUGUST 15, 29; SEPTEMBER 12, 19, 1966

Serial No. 89-43

Printed for the use of the Committee on Interstate and Foreign Commerce

68-985

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 1966

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE

HARLEY O. STAGGERS, West Virginia, Chairman

H.R. 13886-

Commerce, Department of, on H. R. 13886_

Federal Trade Commission on H. R. 13886.-

Concurring statement of Commissioner Philip Elman.

Food and Drug Administration on H. R. 13886_..

Health, Education, and Welfare, Department of, on—

5798

Block, Melvin, attorney, Brooklyn, N.Y.

154

Boland, Hon. Edward P., a Representative in Congress from the State

of Massachusetts..

121

Breck, Edward J., president, Toilet Goods Association.

Connolly, Paul R., of Hogan & Harston, Washington, D.C.....

Delta, Basil G., M.D., medical officer, Bureau of Medicine, Depart-

ment of Health, Education, and Welfare...

122

203, 243

Ellenbogen, Theodore, Assistant General Counsel, Legislation, De-

partment of Health, Education, and Welfare..

Fisher, Richard E., director of public affairs, Glass Container Manu-

facturers Institute...

275

13

107

13, 275

Goddard, Hon. James L., Commissioner of Food and Drug Adminis-

tration, Department of Health, Education, and Welfare__

Goodrich, W. W., Assistant General Counsel, Food and Drug Ad-

ministration, Department of Health, Education, and Welfare... 13, 175

Grider, Hon. George W., a Representative in Congress from the State

of Tennessee..

132

Harvey, John L., counsel, Drug & Allied Products Guild_

Hoge, James F., representing The Proprietary Association.

Holloway, Fuller, counsel, Toilet Goods Association____

128

203, 243

122

Johnson, Albert S., Jr., sales manager, plastics, Glass Container

Division, Owens-Illinois Glass Co...

107

Kahn, Mrs. Fritz R., temporary chairman, Legislative Action Com-

mittee, National Congress of Parents & Teachers..

150

Kinslow, M. D., Director of Legislative Services, Department of

Health, Education, and Welfare..

13

Ligon, E. W., Chief of Hazardous Substances Labeling Branch, Food

and Drug Administration, Department of Health, Education, and

Welfare

Luther, James L., vice president, legal affairs, Sterling Drug, Inc.
McCarthy, Hon. Richard D., a Representative in Congress from
the State of New York.......

Statement of-Continued

Merritt, James H., executive vice president, National Association of
Chain Drug Stores, Inc...

Munsey, Rodney, counsel, Pharmaceutical Manufacturers Associa-
tion_

Palmisano, Dr. Paul, Acting Deputy Director, Bureau of Medicine,

Department of Beath, Education, and Welfare.

Page

152

86

13

203, 243

Paul, Dr. William D., University of Iowa Medical School....

Pilsbury, Richard C., vice president, Glass Container Division,

Owens-Illinois Glass Co..

Riley, Gerald B., general counsel, Glass Container Manufacturers

Institute..

107

107

Ryan, Mrs. Edward, Chairman, Legislative Action Committee,
National Congress of Parents & Teachers__

150

Solmson, Harry B., executive vice president, Plough, Inc., Memphis,
Tenn...

132

Stalbaum, Hon. Lynn E., a Representative in Congress from the State

of Wisconsin..........

119

Stetler, C. Joseph, president, Pharmaceutical Manufacturers Associa-

tion...

86

Sullivan, Charles, Plough, Inc., Memphis, Tenn...

132

Sullivan, Hon. Leonor K., a Representative in Congress from the State
of Missouri.

41

Tainter, Dr. Maurice L., vice president, Sterling Drug, Inc.

Van Riper, Dr. Hart, vice president for medical affairs, Geigy
Pharmaceuticals___

Additional material supplied for the record by-

169

86

American Medical Association, F. J. L. Blasingame, M.D., executive
vice president, letter from__.

307

American Public Health Association, Inc., Berwyn F. Mattison, M.D.,
executive director, letter from.
Arlington Safety Council, Inc., Gaylord B. Kidwell, letter from, with
attachments___

309

331

American Academy of Pediatrics, Committee on Accident Pre-
vention, Samuel C. Southard, M.D., chairman, letter from,
with remarks by Col. Gaylord B. Kidwell, U.S. Army (retired),
before the South Arlington Lions Club, December 8, 1965,
attached.

333

General Federation of Women's Clubs, statement of re safety
latches on refrigerators_

General Federation of Women's Clubs (Mrs. Chittenden, director
of legislation) American Academy of Pediatrics (Dr. Southard,
chairman, accident prevention committee), letter to..
Association of Food & Drug Officials of the United States, Evan
Wright, secretary-treasurer, letter from..

331

332

309

Bell Co., Inc., C. E. Allderdice, Jr., president, letter from..........

Block, Melvin, attorney:

327

Exhibit A-Report of blasting cap accidents by age group and

sex, 1957-65 (table) -

162

Exhibit B-Blasting cap accidents, by States in order of fre-

quency, 1958–62 (table).

163

Exhibit C--Blasting cap accidents, by States in order of fre-

quency, 1963-65 (table).

National Society for the Prevention of Blindness, Inc.

Pennsylvania State Department of Labor and Industry

155

167

Chemical Specialties Manufacturers Association, Inc., statement,

with suggested amendments__

302

Chesebrough-Ponds, Inc., Albert B. Richardson, vice president, letter

from..

324

Commerce and Industry Association of New York, Inc., Arnold Witte;

general manager, letter from.

Additional material supplied for the record by-Continued

Du Pont, E. I., de Nemours & Co., Inc., J. O. Graves, director of

marketing, consumer products division, letter from with attach-

ment entitled "Examples of Federal and State or Local Conflict in

Labeling".

FMC Corp., D. C. Oskin, vice president, marketing, letter from..

Glass Container Manufacturers Institute:

Exhibit A-Illustration depicting bottle safety closures_

Exhibit B-Estimated cost of bottle closures exhibited_

Supplemental statement of Richard E. Fisher, director of public

affairs

Health, Education, and Welfare, Department of:

Letter dated August 28, 1966, re views of Department on amend-

ments proposed by the Chemical Specialties Manufacturers

Association_

Attachment A-Comparison of State hazardous substances

labeling acts with Council of State Governments recom-

mended act (table) -

Letter dated August 29, 1966, transmitting letter sent to Hon.

Warren G. Magnuson, chairman of the Senate Commerce

Committee, re status of fireworks under S. 3298__

Letter dated September 27, 1966, re extent of illness and death as

a result of the ingestion of children's aspirin_ -

Attachment A-Exact entry on death certificate..

Tabulation of children 2 to 5 years of age who ingested 120 or more

grains of aspirin (table)

297

297

278

Heinemann, Dr. Henry O., letter from_

312

Indiana State Board of Health, A. C. Offutt, M.D., State health

commissioner, letter from__

311

Institute of Appliance Manufacturers, Pauline B. Dunckel, executive

secretary, telegram from____

307

Institute of Makers of Explosives, Harry Hampton, secretary, letter

from__

316

McCormack, George H., Jr., M.D., letter from

MacPherson, Archibald R., M.D., letter from_

329

330

Manufacturing Chemists' Association, Inc., G. H. Decker, president,

letter from.

315

Massengill, S. E., Co., Frank W. DeFriece, Jr., president, letter

from

326

National Association of Boards of Pharmacy, statement of

New Jersey Fireworks Manufacturing Co., Inc., A. P. Fabrizi, letter

from.

304

317

324

Olin Mathieson Chemical Corp., Chemical Division, Richard F.
Philpitt, manager, legislative and regulatory affairs, letter from____
Pharmaceutical Manufacturers Association, Č. Joseph Stetler, presi-
dent, letter from____

Plough, Inc., letter dated August 30, 1966, re amount of aspirin con-

sumed yearly

Proprietary Association, The:

Appendix I-"FDA, Industry Officials Agree on Children's

Aspirin Policy: Recommend Label Warning," article from

Drug Trade News of February 28, 1955_-.

308

147

210

Appendix II-Title 21, chapter 1, part 131, of the Code of Federal

Regulations_

211

Appendix III-Outline of principal Federal controls presently

pertaining to packaging and labeling of drugs..

Rawleigh, W. T., Co., J. A. Resh, secretary, letter from..

Rooney, George B., letter from_...

221

328

329

Sterling Drug, Inc.:

Figure 1.-Dosage of aspirin needed per day for several pediatric

indications and for self-medication___.

180

Figure 2.-Mortality from aspirin and methlsalicylate as per-

centage of total fatalities from accidental poisoning-

Figure 3.-Relative mortality from various types of salicylates__

Figure 4.-Recorded ingestions in 2-to-5-year group where age

and dosage are known_-

181

182

186

Figure 5.—Location of substances accidentally ingested, expressed

as percent of total cases..

188