I think a rational balance between these two problems has to be undertaken. This is where I would hope the law as it developed over the last 50 years will continue to develop, will come out to some rational conclusion with reference to consumer responsibility and manufacturer responsibility and public responsibility in what we have to do in terms of prelicensing or product examination and so forth. I commend you and your Commission in spite of the vigorous line of questioning I was pursuing with you in your effort to find an economic way to get the statistics that can be used in this rather significant work and to be darn sure you don't spend 2 years and leave some rather significant gap in what you are trying to do.

Mr. WHITE. Thank you, sir.

Mr. FOUNTAIN. I think we can depend on most of the State legislatures. I don't believe many of them will be able to try to legislate away human frailties. I don't think any manufacturer should be required to do anything more than make it safe against hazards which they might reasonably anticipate.

Some people may misuse things and you can't always anticipate that, but I think the negligence laws of the various States will protect this.

What we are interested in is preventing accidents. I think your Commission is a new force for this. An ounce of prevention is worth a pound of cure. I think your report may be able to not only present some facts but some conclusions and recommendations which may serve to aid industry and Government agencies, local, State, and Federal and the general public and the consuming public in themselves preventing accidents and helping each other.

Mr. BROWN. One of the other things is the process of education and the fact you can educate people to the danger of plastic bags for a period of time. When the education approach lapses, then the plastic bags become just as dangerous-maybe not just as dangerous but relatively dangerous because people have forgotten about the hazards until in their individual case there is an accident.

It was a new product, I hasten to point out, when it got all the publicity. It is an old product now and it is still in some instances dangerous, though the idea of making the plastic heavier is good and I am glad somebody made the recommendation and industry adopted it.

Mr. FOUNTAIN. You put your finger on a key word, education program, public information. If you can get these facts and find out what the hazards are, then a nationwide educational program could encourage people to be more cautious.

Thank you very much, and your colleagues, for coming up.

Our next witness is Dr. Howard Weinstein, Associate Director, Office of Product Safety.

Mr. FOUNTAIN. We are very happy to have you, Dr. Weinstein.

STATEMENT OF DR. HOWARD WEINSTEIN, ASSOCIATE DIRECTOR, OFFICE OF PRODUCT SAFETY, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE; ACCOMPANIED BY ALVIN L. GOTTLIEB, DEPUTY ASSISTANT GENERAL COUNSEL; DR. DENNIS J. McGRATH, CHIEF, DIVISION OF HAZARDOUS SUBSTANCES, OFFICE OF PRODUCT SAFETY; HENRY C. VERHULST, DIRECTOR, DIVISION OF POISON CONTROL, OFFICE OF PRODUCT SAFETY; AND DR. EDWARD J. FAIRCHILD, ACTING DIRECTOR, DIVISION OF SAFETY SERVICES, OFFICE OF PRODUCT SAFETY

Dr. WEINSTEIN. It is a pleasure to be here today to discuss the programs of the Office of Product Safety of the Food and Drug Administration.

After listening to the excellent presentation of Mr. White, I must admit that he has taken a lot of wind out of my sails because he has given you a fair portion of our programs as I planned to present them and I still will.

Mr. FOUNTAIN. You can put it in the record and skip some if you

want to.

Dr. WEINSTEIN. Also, Mr. White answered some of the questions that Mr. Naughton supplied us which I have answered or attempted to answer in my presentation.

The Food and Drug Administration is responsible for administering, among others, the Federal Hazardous Substances Act, section 14 of the Flammable Fabrics Act, and for carrying out a program to protect man from hazardous consumer products under the broad authority of the Public Health Service Act, particularly section 301 which directs the Surgeon General to "conduct in the Service, and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man***." The Office of Product Safety was established in the Food and Drug Administration in December 1968 to administer these programs. It consists of five divisions: the Division of Community Studies, the Division of Hazardous Substances, the Division of Pesticide Registration, the Division of Poison Control, and the Division of Safety Services.

The Division of Poison Control which operates the National Clearinghouse for Poison Control Centers evolved in the following manner: In 1952 the American Academy of Pediatrics conducted a survey of accidents encountered by members in private practice. The study showed poisoning to be the cause of 51 percent of all child accidents reported. This showed the need for a center which physicians could call upon in cases of poisoning by a product whose constituents were unknown.

Under the auspices of the Illinois chapter of the American Academy of Pediatrics, a pilot project, called a poison control center, was initiated in Chicago, with the cooperation of the heads of the pediatric

services in the major hospitals, the health departments, State toxicological laboratories, and other State and local authorities. With the guidance of the American Academy of Pediatrics and its accident prevention committee, similar centers were soon established throughout the country. These centers are usually associated with a medical school or a large hospital.

The primary function of these centers was to obtain toxicity information on almost all toxic or potentially toxic consumer or household products and make this information available to physicians. These centers also tried to keep abreast of current methods of treating poisoning cases.

Because of the ever-increasing number of poison control centers and because of the ever-growing number of consumer products placed on the market by industry, it soon became apparent that there was a need for better information and a means of exchanging information among centers and between the centers and industry.

Accordingly, in November 1956, at a meeting of the American Public Health Association, a recommendation was made that a National Clearinghouse for Poison Control Centers be set up by the U.S. Department of Health, Education, and Welfare. The meeting was attended by representatives from poison control centers and from such national organizations and Government agencies as the American Academy of Pediatrics, American Pharmaceutical Association, Food and Drug Administration, National Research Council, Children's Bureau, and Public Health Service. In compliance with the recommendations, the National Clearinghouse for Poison Control Centers was designated as an activity of the Public Health Service and placed in the accident prevention program.

One of the most important functions of the national clearinghouse is to collect, from many sources, information on poisons and potential poisons. Textbooks and journals of pharacology, medicine, toxicology, and chemistry are consulted, and industry is contacted for information that manufacturers and distributors can contribute in order to keep abreast of new products and changes in the composition of existing products. We go to the manufacturers to find out what is contained in these household products that may be toxic. Government agencies are also a source of pertinent information.

An indexed card file is distributed to those local centers designated by State health departments. The cards, indexed by trade name, or general name, contain information on the composition, concentration, and lethal dose of each specific agent, if known, plus symptoms and treatment. In addition the Division of Poison Control staff is on call for emergency information at any hour of the day or night.

A form for reporting individual poisonings was developed by the national clearinghouse in cooperation with the American Public Health Association, providing a standard record to be used by centers and health departments in recording data on treatment and followup. This form is available to all poison control centers without cost. Approximately 400 centers are currently submitting such data to the national clearinghouse where it is tabulated and analyzed. The reporting system form also furnishes information about the effect of various drugs and other chemicals on human beings.

The problem, in addition to accidental poisonings with which this office deals, is the estimated 18,000 deaths and 20 million injuries associated with other consumer products. These figures have been bandied about quite a bit. This does not include automobile injuries or other transportation accidents. These are consumer products used in and around the home. I have here, which I will submit for the record, a breakdown of these 20 million injuries. This was prepared by our office for the National Commission on Product Safety and represents the best possible estimates on the basis of available information.

(Note: The data referred to appears in the appendix on p. 112.) Mr. FOUNTAIN. What period of time was that? Twenty million injuries, over what period of time?

Dr. WEINSTEIN. October 1968.

Mr. FOUNTAIN. Was that 1 year?

Dr. WEINSTEIN. Yes, sir; 1 year. I have a copy of that document. Mr. FOUNTAIN. Go right ahead.

Dr. WEINSTEIN. The Division of Safety Services of the Office of Product Safety deals with injuries resulting from electrical, thermal, mechanical, and other products used in or around the home. This is different from the other poisonings which we were talking about, chemical in nature. These are electrical, thermal, or mechanical products used in and around the home.

This Division is part of the former injury control program which was part of the National Center for Urban and Industrial Health of the Public Health Service. In the 1968 reorganization of the Department of Health, Education, and Welfare, it was decided that special emphasis should be given to the safety of products marketed for consumer use. Accordingly, the staff, funds and responsibility for this activity were transferred from other PHS programs to the Food and Drug Administration.

The operational plan of the Division of Safety Services to get the facts as they relate to specific products or classes provides for the following sequence of activities: First, a surveillance system has been established which will furnish the information concerning the types and seriousness of injuries and which products are usually associated with these injuries. These are all product connected injuries. Not environmental, particularly, but product connected.

The basic source of data input into this system will be the emergency rooms of selected hospitals from which we will receive reports on admissions for injuries. The report forms used are designed for automatic computer processing to minimize hand processing and expedite analysis for action. Within the past few months we have written contracts with approximately 65 hospitals, nationwide, which will report to us on an established-frequency basis injuries seen in their emergency rooms every second or third or fourth day, depending on volume of emergencies.

This surveillance operation will begin in July of 1969 and is expected to continue on a year-to-year basis. A certain number of the reported injuries will then be investigated in depth, because you can't get a clear picture of the injury just from the hospital record, by our

field personnel and also by State and local health personnel in order to determine the exact circumstances surrounding the injury and also to obtain information concerning the product involved.

We have State people in close contact with local and State health departments and we are hoping to have them develop programs of their own and also to lend help in investigating these injuries involving products.

Using this method on a national scale, data will be compiled which will enable us to pinpoint the problem and determine which products are most frequently at fault. The next step would be either under contract or through in-house resources, if available, to develop a capability for product testing and research as a basis for safety criteria or standards. By this method manufacturers would be able to modify or develop products which would be less likely to cause injury to the

consumer.

The present system for collecting data on product injuries may be divided into the following categories:

1. Poison control centers reports. These reports are submitted voluntarily on a standard form and consist of reports of ingestions of household substances. They also include all products used in the home liable to produce poisonings, for example, drugs, pesticides, household products, and cosmetics.

2. Hospital reporting of injuries which are product related. This will be done under contract with approximately 65 hospitals beginning in July 1969.

3. Contract with the University of Michigan on the etiology of burns. Burns have first priority in injuries under our responsibility to the Flammable Fabrics Act.

4. Contract with the University of Iowa for a study of farm injuries including burns.

5. Two study teams located in Boston and Denver conduct indepth investigations and report on product-related injuries which are seen in the surrounding hospitals. We have copies of these reports. These are the reports Mr. White spoke about as being given to his Commission. We have very many reports. The reason he didn't receive all of them is not only the lack of facilities to process them but also because many of these reports concern burn injuries which the Commission at present is not looking into.

6. In addition to extensive use of the poison control center reports, the Division of Hazardous Substances collects data and information from the following sources:

(a) Copies of death certificates where deaths are due to hazardous substances, rather than natural causes, are received directly from 36 States and 13 States from the Division of Vital Statistics of the U.S. Public Health Service.

(b) Food and Drug district inspectors' investigations and followup reports.

(c) Consumer complaints and newspaper items.

(d) Literature searches and consultation with outside experts.