the evidence, heard the experts, had the material tested, and gone through the entire matter, then if you are dissatisfied with his opinion, under this bill, you then go into the district court and treat the matter as if it had never been tried before; is that right? Mr. DUNN. Oh, no, you don't. You only do it in very, very rare cases.. I will tell you that the clients I represent would never go into court under this amendment. The CHAIRMAN. May the Chair request both the witness and Mr. Dies to talk separately? If Mr. Dies is talking, it is terribly confusing for the reporter to have Mr. Dunn talking also, and I make the request that we proceed in that manner, so that the reporter can get an accurate transcript. Mr. DUNN. Forgive me, Mr. Dies. I was so interested in this thing. Mr. DIES. Theoretically we must assume that you can go into the court in every case. Mr. DUNN. But you will not. Mr. DIES. I understand your point. But when we go to legislate, we give you the power, here, to take every case and go into the district court and try it as if it had never been heard by the administrative party; isn't that a fact? Mr. DUNN. You might just as well argue that the Food and Drug Administration would bring a regular injunction or a seizure or a criminal action in every case of violation of the act. And they don't. They are relatively the exceptional thing. Mr. DIES. I understand your argument is that while theoretically you can do it, as matter of practice it will not be done; is that right? Mr. DUNN. No, sir. It will not be done. Mr. DIES. And it will only be in rare instances that it will ever be used. Mr. DUNN. That is correct, sir. Mr. DIES. Then why do you object to using the administrative act, as it is used in every other instance? Mr. DUNN. I will tell you why I object to it. Because the administrative act gives the FDA the power of advanced administrative approval or in effect a Government license control of the food additives. And I am utterly opposed, and my industry is opposed, to the Government licensing the food industry. We have the largest industry in America. Last year it did $68 billion worth of business. Now, we have, from the very beginning of this food law, in 1906, tried to keep this law away from the Government licensing field. And we have succeeded in doing so until the issue has come up here. Mr. DIES. But if, as a matter of practice, what you say is true, that it will be very rare indeed that you ever go to any Court, why do you object to availing yourself of the Administrative Practice Act, the same as every other aggrieved party is compelled to do. Mr. DUNN. Because you overlook the basic fact that you have got to go to the FDA regardless of a court proceeding to get permission to use any additive, whether you go to court or not. We just don't want that. What we want is to do what we have always done, and that is to submit the facts to the FDA, let it decide, and then if there is a difference of opinion we go to the court to adjudicate that opinion, if we want to. FEDERAL FOOD, DRUG, AND COSMETIC ACT 137 Mr. DIES. Of course, the thing I am very much concerned about here, and I haven't reached any conclusion on it: It is the administrative practicability or feasibility of this provision. If we make an exception, and let your industry go into the district court de novo and open up that door, it seems to me that there never would be an end to it. I would like to do it myself. I handled some NLRB cases before I came to Congress. I would have given anything to have tried every one of them de novo in the district court, on many other administrative matters. Mr. DUNN. Even if it is sound, Mr. Dies, to have an advanced FDA approval on every significant scientific question under the law, then you are logically driven to the point that all scientific labeling claims, that all scientific questions about the mold count of food, which you know in the growing of tomatoes is so important in the Midwest, and all of these other scientific questions, would have to be submitted to the FDA, and you would have to get an FDA opinion in advance before you could go any further. Now, that is just simply converting this act from a straight, simple regulatory law, which we have always had since 1906, into a Government license control of the food industry. We just don't want that. We are utterly opposed to that. Mr. DIES. No; what you want is a predetermination, a declaratory judgment. But if you don't like it, you want to try the whole case over again in the district court. Because Mr. Duxx. I find it difficult to follow that statement. what I have tried to say to you, Mr. Dies, is this: That 95 percent of the issues under this amendment will be administratively ironed out. I know that is so, because I have been dealing with the new drug law since 1938. And only in these rare cases will you find a manufacturer who feels the issue is so important to him that he is willing to risk the Mr. DIES. Mr. Chairman, I was notified that there will be a quorum call immediately, so I will not ask any more questions. Mr. SPRINGER. No questions, Mr. Chairman. The CHAIRMAN. Thank you very much, Mr. Dunn, for your appearance, and we hope your health improves rapidly. Mr. DUNN. Thank you, sir. The CHAIRMAN. May the Chair state the bells have rung and there will be a quorum call shortly, and it is the intention of the Chair and the subcommittee to hold an afternoon session beginning at 2:30. Mr. Anthony Eden is to address the House, and it will be at least that time before Members of the House will be able to return, without walking out on Mr. Eden, which we certainly do not want to do, for a subcommittee hearing. May the Chair further state this-and I do this not in any desire to shut off the time of any witness, but the Chair feels that a great deal of the testimony from this point on may be somewhat repetitious, and the Chair invites witnesses who will appear in the afternoon session, if they so desire, to give an oral statement, with the understanding that their complete written statement may appear in the record, in the interest of accommodating a number of witnesses who have other engagements and need to keep them if possible. We have received, the committee has received, a report, a rather complete report and analysis, of the legislation from the Department 138 FEDERAL FOOD, DRUG, AND COSMETIC ACT of Health, Education, and Welfare. This report was turned over to the chairman this morning. And without objection, it will go into the record. (The report referred to is as follows:) Hon. J. PERCY PRIEST, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Chairman, Committee on Interstate and Foreign Commerce, House of DEAR MR. CHAIRMAN: This responds to your requests for reports on H. R. 4475, H. R. 7605 (with which H. R. 7606 is identical), H. R. 7607 (with which H. R. 7764 is identical), H. R. 8271, H. R. $275, and H. R. 8748. (We understand that a report is no longer desired on H. R. 4099, H. R. 4100, and H. R. 5927, which are intended to be superseded by H. R. 7605, H. R. 7606, and H. R. 8748, respectively.) These bills are all to "protect the public health" by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety. PURPOSE AND NEED FOR THIS PRETESTING LEGISLATION These bills deal, with the problem of safety to the consumer arising from the widespread and increasing use of chemicals in modern food processing technology. Within the last 20 years hundreds of chemical substances have been added to foods, and the search for new chemicals to "improve" foods is being accelerated. Many have not been subjected to adequate scientific investigation to determine their safety. It is essential to the public health that we know that proposed ingredients are safe-before they are used in food. The hazards are too great to justify any other procedure. Under existing law, poisonous and deleterious substances may not be added to food in any amounts unless they are required or cannot be avoided. When they are required or unavoidable, the Department is authorized to establish safe tolerances for them. But no action can be taken to stop the use of a chemical until we can prove that it actually is a poisonous or deleterious substance. This proof requires a minimum of 2 years of laboratory experimentation with small animals, and while we are obtaining the proof the chemical can be used. An adequate statutory pretesting requirement would require the person offering the chemical for food use, rather than the Government, to obtain evidence about its safety before it is sold. This should go far to overcome a serious gap in consumer protection by eliminating the hazards from consumption of untested or inadequately tested chemicals in food. We, therefore, endorse the objectives of these bills, and recommend the enactment of legislation on the subject. So far as we know, there is no responsible group in either the food or chemical industries that opposes the objectives of the legislation. We believe, however, that certain amendments, summarized below, are necessary to achieve the desired protection, and that the approach utilized in some of the bills, as explained below, is not appropriate to the effec tive accomplishment of their sound objective. 1. Summary of recommended amendments for all bills (cxcept as specificd) To summarize these amendments, we believe that (1) the definition of "new chemical additive" should be clarified so as plainly to include any radioactive material purposefully or unavoidably introduced into foods either by the use of radioactive materials in food processing or as a source of radiation (e. g., isotopes) for the irradiation of foods; as well as any changes brought about in the food itself or new substances, including radioactive elements, formed in the food as a result of subjecting it to radiation; (2) the legislation should require that a chemical additive that is not plainly a harmless substance should be approved only if it has some defiite functional value to justify its use; (3) it' should be made specific that the bills apply to chemicals used in food for lower animals as well as to food products derived from such animals, such as eggs, milk, or meat; (4) the bills (except H. R. 4475) should be amended to authorize the collection of fees to defray the cost of the legislation; (5) the bills (except H. R. 4475) should be technically perfected to provide that use of a new chemical FEDERAL FOOD, DRUG, AND COSMETIC ACT 137 Mr. DIES. Of course, the thing I am very much concerned about here, and I haven't reached any conclusion on it: It is the administrative practicability or feasibility of this provision. If we make an exception, and let your industry go into the district court de novo and open up that door, it seems to me that there never would be an end to it. I would like to do it myself. I handled some NLRB cases before I came to Congress. I would have given anything to have tried every one of them de novo in the district court, on many other administrative matters. Mr. DUNN. Even if it is sound, Mr. Dies, to have an advanced FDA approval on every significant scientific question under the law, then you are logically driven to the point that all scientific labeling claims, that all scientific questions about the mold count of food, which you know in the growing of tomatoes is so important in the Midwest, and all of these other scientific questions, would have to be submitted to the FDA, and you would have to get an FDA opinion in advance before you could go any further. Now, that is just simply converting this act from a straight, simple regulatory law, which we have always had since 1906, into a Government license control of the food industry. We just don't want that. We are utterly opposed to that. Mr. DIES. No; what you want is a predetermination, a declaratory judgment. But if you don't like it, you want to try the whole case over again in the district court. Mr. Duxx. I find it difficult to follow that statement. Because what I have tried to say to you, Mr. Dies, is this: That 95 percent of the issues under this amendment will be administratively ironed out. I know that is so, because I have been dealing with the new drug law since 1938. And only in these rare cases will you find a manufacturer who feels the issue is so important to him that he is willing to risk the Mr. DIES. Mr. Chairman, I was notified that there will be a quorum call immediately, so I will not ask any more questions. Mr. SPRINGER. No questions, Mr. Chairman. The CHAIRMAN. Thank you very much, Mr. Dunn, for your appearance, and we hope your health improves rapidly. Mr. DUNx. Thank you, sir. The CHAIRMAN. May the Chair state the bells have rung and there will be a quorum call shortly, and it is the intention of the Chair and the subcommittee to hold an afternoon session beginning at 2:30. Mr. Anthony Eden is to address the House, and it will be at least that time before Members of the House will be able to return, without walking out on Mr. Eden, which we certainly do not want to do, for a subcommittee hearing. May the Chair further state this and I do this not in any desire to shut off the time of any witness, but the Chair feels that a great deal of the testimony from this point on may be somewhat repetitious, and the Chair invites witnesses who will appear in the afternoon session, if they so desire, to give an oral statement, with the understanding that their complete written statement may appear in the record, in the interest of accommodating a number of witnesses who have other engagements and need to keep them if possible. We have received, the committee has received, a report, a rather complete report and analysis, of the legislation from the Department 138 FEDERAL FOOD, DRUG, AND COSMETIC ACT of Health, Education, and Welfare. This report was turned over to the chairman this morning. And without objection, it will go into the record. (The report referred to is as follows:) Hon. J. PERCY PRIEST, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D. C. DEAR MR. CHAIRMAN: This responds to your requests for reports on H. R. 4475, H. R. 7605 (with which H. R. 7606 is identical), H. R. 7607 (with which H. R. 7764 is identical), H. R. 8271, H. R. $275, and H. R. 8748. (We understand that a report is no longer desired on H. R. 4099, H. R. 4100, and H. R. 5927, which are intended to be superseded by H. R. 7605, H. R. 7606, and H. R. 8748, respectively.) These bills are all to "protect the public health" by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety. PURPOSE AND NEED FOR THIS PRETESTING LEGISLATION These bills deal, with the problem of safety to the consumer arising from the widespread and increasing use of chemicals in modern food processing technology. Within the last 20 years hundreds of chemical substances have been added to foods, and the search for new chemicals to "improve" foods is being accelerated. Many have not been subjected to adequate scientific investigation to determine their safety. It is essential to the public health that we know that proposed ingredients are safe-before they are used in food. The hazards are too great to justify any other procedure. Under existing law, poisonous and deleterious substances may not be added to food in any amounts unless they are required or cannot be avoided. When they are required or unavoidable, the Department is authorized to establish safe tolerances for them. But no action can be taken to stop the use of a chemical until we can prove that it actually is a poisonous or deleterious substance. This proof requires a minimum of 2 years of laboratory experimentation with small animals, and while we are obtaining the proof the chemical can be used. An adequate statutory pretesting requirement would require the person offering the chemical for food use, rather than the Government, to obtain evidence about its safety before it is sold. This should go far to overcome a serious gap in consumer protection by eliminating the hazards from consumption of untested or inadequately tested chemicals in food. We, therefore, endorse the objectives of these bills, and recommend the enactment of legislation on the subject. So far as we know, there is no responsible group in either the food or chemical industries that opposes the objectives of the legislation. We believe, however, that certain amendments, summarized below, are necessary to achieve the desired protection, and that the approach utilized in some of the bills, as explained below, is not appropriate to the effec tive accomplishment of their sound objective. 1. Summary of recommended amendments for all bills (cxcept as specificd) To summarize these amendments, we believe that (1) the definition of "new chemical additive" should be clarified so as plainly to include any radioactive material purposefully or unavoidably introduced into foods either by the use of radioactive materials in food processing or as a source of radiation (e. g., isotopes) for the irradiation of foods; as well as any changes brought about in the food itself or new substances, including radioactive elements, formed in the food as a result of subjecting it to radiation; (2) the legislation should require that a chemical additive that is not plainly a harmless substance should be approved only if it has some defiite functional value to justify its use; (3) it should be made specific that the bills apply to chemicals used in food for lower animals as well as to food products derived from such animals, such as eggs, milk, or meat; (4) the bills (except H. R. 4475) should be amended to authorize the collection of fees to defray the cost of the legislation; (5) the bills (except H. R. 4475) should be technically perfected to provide that use of a new chemical |