Mr. BROWN. I think if you do that, you may be making it legal for the promoter to abrogate his responsibility, then, to test his own product, and then have it tested by an independent laboratory or the Government. Senator NELSON. No; I think he does whatever preliminary testing he is required to do; then he submits it to the FDA; and the FDA then contracts for a nonpartisan evaluation by reliable, independent, scientific contractors under a protocol established by the FDA and paid for by the company. Mr. BROWN. You are suggesting in effect a double testing of all products. Of course, that is done in the case of drug additives. Senator NELSON. No; there is no double testing of drugs. FDA doesn't double test drugs. Mr. BROWN. FDA is going through the GRAS list with NAS/NRC to have them determine Senator NELSON. I thought you were talking about prescription drugs. They are going through the GRAS list now, but under the prescription drugs Mr. BROWN. You suggested there were a great many additives on the market, and I suggested that the GRAS list is an example of programs of that kind of circumstance, and we have been, how many years, sir, waiting for the FDA to complete the tests on the GRAS list. I don't need to start asking questions, because it is not appropriate for me to, but if we would review all of the current food additives on the market, and I would say that would be true of common table salt, because of the problem I have cited here with reference to hypertension, then does the question become, "Do we take those things off the market until NAS/NRC or some other agency gets around to approving them, or do we leave them on the market until the Federal Government gets around to finding out they are not desirable?" And what would be the legal responsibility, then, if the Federal Government has not acted on something that turns out in the final analysis to be harmful to the American public? Is there culpability on the part of the Government? I am not sure that I can alone answer those questions. I think they are questions that have to be answered by the Congress. In the case of the cyclamates, we took action, as you know, to indemnify those who were harmed by the removal of cyclamates from the market, and I think there are serious questions in that whole philosophy. Senator NELSON. What I am suggesting is that those already in the marketplace have to be dealt with in one way, and those that haven't come into the marketplace have to be dealt with in another way. A few years ago the FDA had new applications for 476 additives in 1 year, and if you check back I think you will see that there have been 150 to 200 or 300 or 400 requests per year for new food additives. NEED TO ESTABLISH A PROTOCOL I think we now just have to establish a protocol which simply says that additives will have to be tested independently, and the tests paid for by the producer. Reliance should be on a couple of things: Safety, proof that it is a valuable contribution to the product, proof that there is no other product on the marketplace that does what that particular product purports to do. If there is a coloring in the marketplace that has been used for 10 or 20 years, and another product is offered only for coloring purposes, I think we ought to say "No." Mr. BROWN. Short of an improvement over the coloring additive, I would agree. Senator NELSON. Improvement is another matter. Well, the other point that I would like to make-and you have obviously spent considerable time in the field-is the suggestion by those who criticize the Delaney law that, after all, you would have to eat 5 pounds per day of a product before the human being would get a carcinoma. Therefore, the view is, "What kind of nonsense is that?" Mr. BROWN. In some cases, 500 pounds. Senator NELSON. Yes. That was the argument used against DDT. When Rachel Carson suggested it ought to be removed from the marketplace, all of the scientists in the country attacked her. Those who addressed themselves to the question attacked her as incompetent as a scientist, except those who understood something about biologic magnification in the food chain, which she did. Mr. BROWN. And a cumulative effect, I guess. SIGNIFICANCE OF SMALL AMOUNTS Senator NELSON. That is right. That is what I mean. The fact is that one part per trillion in the water becomes one part per billion in the plankton and two parts per billion in the small fish and 10 parts in the larger fish, and, finally, 19 or 20 parts in various subspecies of the peregrine falcon and the bald eagle, for example, thus threatening creatures in this country with extinction. People say one part per billion can't be significant. If the product is not rapidly degradable biologically, if it accumulates in the food chain, one part per billion or one part per trillion can be very significant. So I am not impressed by those who say, "Oh, you have to eat five pounds per day." Where does it concentrate? Does it concentrate in the liver, does it have the effect that DDT did on subspecies of the bald eagle, inhibiting the capacity of the female to produce enough calcium for a shell strong enough to hold the chick so that the chick can survive? All this was pooh-poohed by entomologists all over this country, and I have been through this with them. I introduced the first legislation in this Congress to ban DDT. I was attacked all over my State, by our own conservation department, by scientists, and all the rest, as being unqualified to make a judgment in this field. We found disasterously that DDT does stay in the environment, the half-life perhaps is 10 or 12 years. It has had a disasterous effect worldwide. Finally, we got rid of it. QUESTION OF ACCUMULATION But when you are dealing with a product that produces cancer in an animal, I think that those who want to use that product ought to have the burden of proving that it does not accumulate somehow in some organ in the body and have some effect 10 or 20 or 30 years later. If the people who want to add the additives would agree to some protocol like that, I don't think we will have trouble passing the law. Mr. BROWN. I did not go into, in my testimony, the matter of the cumulative nature of some substances, and that other substances are not cumulative. I would assume that the subcommittee recognizes these differences, and I would assume that you would assume that I wasn't defending DDT with this testimony here. I think we must be careful in informing the public because we are stewards of theirs, too, concerning substances that are cumulative and those which are not, and a number of other distinctions in the chemical nature of the substances, so that we do not lump together, as a lot of people want to lump all narcotics together or all drugs together in one package, both beneficial substances and harmful substances, either identifying them as harmful or beneficial. I think we have to exercise some judgment in this matter. I think that the Delaney clause does not now permit the exercise of that judgment, and in fact, that is what I am calling attention to in my testimony. Senator NELSON. I know. I made that comment because I realized you weren't going into detail, but because you did mention that massive doses given laboratory animals were in excess of what a human would get, and could cause a product to be prohibited from the marketplace. I wanted to make the point that it seems to be a commonly accepted view that you have to eat 5 pounds of something a day to get cancer. Therefore, critics say, the Delaney section is a foolish regulation. Mr. BROWN. That depends on the product, and I think the same thing may be said about the Panalba, thalidomide cases. Panalba did not do what people might think it would do cumulatively. It did basically what either one would do separately. Thalidomide was an entirely different matter, which did something we didn't want done, in effect, because of the side effects of the drug. Senator PERCY. Congressman Brown, we are delighted to have you here this morning, and you obviously have a fine background in this field. I was pleased that you did open your statement by saying that you feel the health and economic impact is such that an indepth congressional study is warranted. We will try to fulfill this mission. Do you have any comments at all on the nutrition labeling aspects of our hearing, as to the necessity of them, the desirability of nutritional labeling? HONEST AND FULL DISCLOSURE OF PRODUCT Mr. BROWN. I think any nutritional labeling or advertising which is done should be honest. You should not claim for your product things, and I think this ought to be law, or quality that it does not have. In that regard, then, some identification of what those qualities are is necessary. I certainly feel very strongly that the full disclosure of as much as the consumer can logically absorb is beneficial. I think, however, that we have to recognize that if the print becomes 12 lines at the bottom of the can and includes technical terms, the average consumer does not understand that it may not be as beneficial as those of us Senator PERCY. Would you think it desirable in setting such standards to make it in a way that is understandable and in a print size that is reasonable? Mr. BROWN. I think with respect to the adverse effects that we would have to also set standards, in order to permit the advertising of beneficial effects. Senator PERCY. I have no further questions, Mr. Chairman, because I do feel we have to get on with our other witnesses, although Senator Taft has joined us. I have a markup on a bill and a quorum is required upstairs, and I will have to go up, but I will be back after that. Senator NELSON. Senator Taft? Senator TAFT. Thank you, Mr. Chairman. I have no questions for my colleague. I appreciate his views. Senator NELSON. Thank you very much, Congressman Brown, I appreciate your taking the time to come over here this morning. Mr. BROWN. Thank you. Senator NELSON. Our next witness is Dr. John Olney, Washington University School of Medicine, St. Louis, Mo. Dr. Olney, the committee is very pleased to have you here this morning. STATEMENT OF DR. JOHN OLNEY, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, ST. LOUIS, MO. Senator NELSON. Your statement will be printed in full in the record. You may present it however you desire. Dr. OLNEY. Thank you, Senator Nelson, and Senators Percy and Taft. The remarks I intend to make will pertain to the kind of criticism that is made of the Delaney clause, very popular criticism, which is that it doesn't provide for the exercise of scientific judgment. I hope it will be clear from my testimony that there are some real problems in deciding what is meant by "exercise of scientific judgment." For example, whose scientific judgment should be applied, how should it be applied, and how can we prevent it from being abused. I would like to make clear to begin with that although my testimony may seem to be antagonistic or something of an attack upon scientific colleagues, or on industry, or upon certain agencies, its purpose will be lost if viewed simply as that. LOOSE SYSTEM IN NEED OF REFORM I mean it to be a criticism of a system which is currently in use-a rather loose system which I believe is in need of reform-for evaluating food additives, and arriving at regulatory policies pertaining to them. I have been doing research over the recent 5 years or so with a common food additive, monosodium glutamate. In 1969 I reported to this committee that the common food additive, monosodium glutamate (MSG) damages the central nervous system of infant animals. Since that time many laboratories have published reports confirming, and in some instances expanding upon this evidence. I would like to make specific reference to several reported studies to provide examples of the kind of evidence which has come forth in the last 3 years in support of my findings as reported to this committee in 1969. The first researchers who reported confirmatory evidence were Drs. Ed Arees and Jean Mayer from the Department of Nutrition at Harvard. Dr. Mayer is currently President Nixon's adviser on nutrition. Their study was entitled Monosodium Glutamate-Induced Brain Lesions.* STATEMENT OF BRAIN DAMAGING PROPERTIES OF MSG I would like to read a statement briefly from their paper which unequivocally confirmed the brain damaging properties of MSG. It states: "We were consistently able to produce lesions in the brain of Swiss albino mice, with single doses of MSG." The next confirmatory report was by Drs. Barde et al., a group of scientists who specialize in working with the central nervous system and use the electron microscope in this work. The lowest doses of MSG tested 1g/kg, by either oral or subcutaneous administration, produced brain lesions in 100 percent of their rodent infants. The next researchers I would like to mention, Drs. Johnston and Reynolds, reported their findings recently at the 1972 meeting of the American Association of Anatomists. They reported confirmatory evidence along exactly the same line that a single 1g/kg oral dose of MSG consistently produced lesions in the infant mouse brain. Drs. Murakami and Inouye** of Japan demonstrated the same lesions in infant mice from the same dose level 1g/kg, and they went further; they studied the effects on fetal brain of treating pregnant mice. They demonstrated typical MSG lesions in the fetal brain after treating the mother with MSG. I have confirmed those findings in fetal brain. John Everly from the Washington area published a paper in 1971, "Light Microscopic Examination of MSG-Induced Lesions in Brain of Fetal and Neonatal Rats." This was in the rat, the previous study I just mentioned was in the mouse. In this study he found brain lesions in both fetal and neonatal rats following treatment with MSG. Snapir et al., treated chicks with MSG and found brain lesions. Redding and Shalley, neuroendocrine specialists at Tulane University in New Orleans, with colleagues published a paper entitled "Effects of Monosodium Glutamate on the Endocrine Axis in Rats."*** *See Appendix, p. 879. |