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1 Hospitalized cases are due to products containing petroleum distillates. • Category breakdown not available for 1966.

Category breakdown not available for D. and E., 1967.

Mr. FOUNTAIN. You get how many reports?
Dr. McGRATH. I think it was 110.

Mr. VERHULST. I think you meant 110,000.

Dr. McGRATH, Yes, 110,000 of which we calculate 22 approximately involved these.

Mr. FOUNTAIN. Approximately how many of the injuries reported received medical followup?

Dr. McGRATH. As Dr. Weinstein mentioned, I think we perform a unique function in pursuing in-depth field investigation of significant injuries that we receive whereby we have our district inspector gofirst of all, we have to get permission

Mr. FOUNTAIN. I was interested in how many. Not the details. We can go on and on with that, I am sure.

Dr. MCGRATH. Sorry. Oh, 186 up to the 16th of May for fiscal year 1969. We estimate about 200 by the end of the year.

Mr. FOUNTAIN. What criteria do you use in determining whether or not a particular reported injury is significant?

Dr. MCGRATCH. Well, it is a medical evaluation of the raw data as it comes in and we decide is this a product or chemical about which not too much is known of human injury experience and we feel that further information should be developed, or else it may be a product that is a known hazardous substance and we find there are too many injuries occurring so something is wrong. Either toxicity should be reduced or safety closures or something should be added to it.

Mr. FOUNTAIN. In approximately how many instances would you estimate that data received through accident reports has resulted in the removal of hazardous products from the market during the past 3 years?

Dr. McGRATH. We are involved in one currently which is the carbon tetrachloride. Up to the amendment of 1966, the job protection amendment of the Hazardous Substance Act, it was almost impossible to remove a product, no matter how hazardous, from coming into the household as long as you put a certain stated warning, be it danger or caution or skull and crossbones. As of since then we can, and this is the first case. No, there was another one. I think it was X-33, something to paint, some preparation for basements, some kind of paint or something that was highly explosive.

Also there were some cracker ball things that resembled children's candy.

Mr. FOUNTAIN. About how long would it normally take to get a hazardous product off the market after receiving information indicating that it is hazardous?

Dr. McGRATH. This is an administrative procedure. We develop the background information which we feel is the medical support for any position to be taken. It depends on several factors and sometimes these processes are slow legally. It takes time to get around to—

Mr FOUNTAIN. Of course to get into courts

Dr. MCGRATHI. May I add-I forget here. Toy tunnels were removed. Flammable fabrics. These were declared a hazardous substance as well.

Mr. FOUNTAIN. They voluntarily removed them afterwards.
Dr. McGRATH. Yes. And inflammable dolls?

Mr. NAUGHTON. Is there an emergency procedure for getting something that is extremely hazardous off the market?

Dr. McGRATH. Yes, sir. First you have to develop the data to support your position because we feel this is a hazardous substance and shouldn't be on the market, it is not enough. We have to develop the background medical information to stand up at a hearing or in court.

Mr. NAUGHTON. Suppose you discovered the existence on the market of a substance you felt extremely hazardous. You had no problems. in proving it. No difficulty of legal nature at all. How quickly could you get it off the market?

Dr. MCGRATH. I couldn't answer that question.

Mr. GOTTLIEB. There is a provision for the Secretary to issue an order in the Federal Register banning the substance immediately and holding a hearing thereafter.

Mr. Naughton.

Mr. NAUGHTON. So it could be done without any delay at all, Mr. Gottlieb.

Mr. GOTTLIEB. Yes. There must be an imminent hazard to health.
Mr. NAUGHTON. Similar to the provision in the Pesticide Act.
Mr. GOTTLIEB. That is correct.

Mr. NAUGHTON. How long would you estimate it would normally take under the regular removal procedure? A year or so?

Mr. GOTTLIEB. What kind of removal are you referring to? Dr. McGrath has lumped two types of situations in his removal from the market answer. One of them involves a formal hearing where the Secretary, on finding of all the facts, determines that an article is a banned hazardous substance which can't be labeled in a manner which the public can use safely. This requires formal hearing before a hearing examiner, and the carbon test is such a hearing which is going on right now with appeal to the courts.

As the chairman pointed out, I am not about to suggest how long that may take.

The other is simply our normal regulatory activity. Seizures or notification to the firm that we are about to do something so they recall their products, or refusual to permit foreign products into the country, which was the rag doll situation, which was in part an import detention situation. Frequently when we are about to take action or have taken preliminary action such as seizure, the companies withdraw their products.

Mr. NAUGHTON. Recall action would be voluntary.

Mr. GOTTLIEB. Yes.

Mr. NAUGHTON. Seizure would apply to a product which has already been banned and still on the market.

Mr. GOTTLIEB. Not necessarily banned. Simply one that violates the law.

Mr. NAUGHTON. Is in violation of the law and is on the market. Mr. GOTTLIEB. Yes. So we have to go to court. This is patterned in the same manner as the Food and Drug Act. We have to go to court to get a court order to seize the product and then there is a trial to determine whether the article is indeed violating the law or not. This again takes some time.

Mr. FOUNTAIN. Can you tell us how many prosecutions and/or convictions there have been under the criminal provisions of the Hazardous Substances Act?

Mr. GOTTLIEB. I am not sure. I really can't give you a definitive answer on that but I don't think there have been more than two or three criminal prosecutions. We have had quite a few seizure cases and injunction cases so far as I can recall.

Mr. DWYER. No questions.

Mr. NAUGHTON. In your statement you indicated you are now providing information to the Department of Commerce on injuries associated with flammable fabrics. What is the nature of the data being reported? How frequently have you made those reports to the Departnent of Commerce?

Dr. WEINSTEIN. When we investigate a burn injury, if it is possible we try to get a sample of the fabric that is involved. The ignition of the fabric involved. This, together-this sample together with the report of the case, the circumstances, is submitted to Mr. Ryan of the Bureau of Standards of the Department of Commerce for analysis to see whether it meets the standards. The number-Dr. Fairchild, do we have

Dr. FAIRCHILD. Total number sent to Commerce? About roughly

285.

Mr. NAUGHTON. These are individual reports you feel would be of interest to them?

Dr. FAIRCHILD. Yes, sir. You see, quite often, unless you have a good surveillance and in depth investigation, you don't get to the scene of the accidents. This is especially true with burns. You lose all chance of recovering the garment so we have many more burn investigations or records than we do actual samples that are tied or were involved with this.

Mr. NAUGHTON. One last question.

The Flammable Fabric Amendments of 1967; do they provide a report be furnished to the Congress at least annually?

Dr. FAIRCHILD. Yes.

Mr. NAUGHTON. Has that been submitted?

Dr. WEINSTEIN. Yes, sir.

Mr. NAUGHTON. When was is submitted?

Dr. WEINSTEIN. It is

Dr. FAIRCHILD. In our office in April

Dr. WEINSTEIN. Of 1969. It is in the Department now.

Mr. NAUGHTON. It is over a year and a half since the passage of the act but no report has yet been submitted to the Congress?

Dr. WEINSTEIN. To my knowledge it is in the Department of Health, Education, and Welfare.

Mr. NAUGHTON. How long has it been in the Department of Health, Education, and Welfare, Mr. Weinstein?

Dr. WEINSTEIN. I don't know.

Mr. NAUGHTON. Well, it was sent over in April; was it?

Dr. WEINSTEIN. Yes.

Dr. FAIRCHILD. There have been many revisions. I don't know where it is. I don't know how long it [Laughter.]

Mr. NAUGHTON. Would you provide information on that for the record?

Dr. FAIRCHILD. Yes, sir.

Mr. FOUNTAIN. That is rather typical [Laughter.]

Mr. FOUNTAIN (continuing). Of the Federal Government.

(The following information was subsequently provided:)

Following is a brief chronology of events on submission of the Secretary's First Annual Report to the President and Congress as required under section 146(a) of the Flammable Fabrics Act of 1967.

July 1968, draft report submitted to CPEHS by injury control program.
Review by FDA requested by CPEHS.

October 1968, draft submitted by FDA and forwarded by CPEHS to the Office of the Secretary.

December 17, 1968, returned to FDA by CPEHS with memo saying it had been "returned by the Office of the Assistant Secretary for Health and Scientific Affairs for revision and updating."

January 24, 1969, revised report submitted to CPEHS and forwarded to Office of Assistant Secretary for Health and Scientific Affairs where it was reviewed in late February. Report was not acceptable.

March 6, a meeting of representatives of the Office of the Secretary, CPEHS, FDA, and the Office of Product Safety was held to discuss changes needed.

April 10, revised report submitted to Office of Commissioner, FDA, and returned to Office of Product Safety because report was unacceptable.

June 11, submitted by FDA to CPEHS.

June 17, returned to FDA by CPEHS for changes,

June 24, returned by FDA to CPEHS.

June 26, submitted to Department by CPEHS.

July 1, minor revisions and clarifications requested by Department from CPEHS.

July 3, the revisions were made and the report was sent to Assistant Secretary for Health and Scientific Affairs.

July 14, hand carried from Assistant Secretary for Health and Scientific Af· fairs to the Secretary's office.

Mr. BROWN. Dr. Weinstein, I wanted to inquire how many various agencies come under the Consumer Protection Environmental Health Services of the Department of Health, Education, and Welfare.

Dr. WEINSTEIN. There are three, the Food and Drug Administration, ECA, Environmental Control Administration, and the National Air Pollution Administration.

Mr. BROWN. And you are under which of those?
Dr. WEINSTEIN. Food and Drug Administration.

Mr. BROWN. And how many offices or bureaus are under the Food and Drug Administration?

Dr. WEINSTEIN. Five. Bureau of Medicine, Bureau of Veterinary Medicine, Bureau of Compliance, Bureau of Science

Mr. BROWN. That is five bureaus. How many offices?

Dr. WEINSTEIN. The only offices there is the Office of Legislative Service and then in the Bureau of Medicine there are four offices, Office of New Drugs, Office of Marketed Drugs, Office of Medical Support, and Office of Product Safety.

Mr. BROWN. Let me spare you the necessity of reciting all these. In a hearing we had in the Interstate and Foreign Commerce Committee, there was presented a listing of the various jurisdictions and their responsibilities, which responsibilities are briefly outlined, normally take three to five lines, occupy pages 107 to 124 in those hearings. As I sat here and figured out during your testimony, there is something like 138 separate jurisdictions in the area of Consumer Protection and Environmental Health Services. I note that among these are 12 which deal directly, I gather, with the various areas of consumer protection, accidents, hazardous products, and so forth.

I will take just a minute to recite these: Office of Product Safety, Division of Community Studies, Division of Hazardous Substances, Division of Pesticide Registration, Division of Poison Control, Divi

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