66 FEDERAL FOOD, DRUG, AND COSMETIC ACT make any suggestions for the improvement thereof which I should deem advisable for the realization of said principles, and to participate in drafting any suggested revisions. Since then I have spent a substantial amount of time and have worked with numerous lawyers in drafting or revising various proposed bills. The CHAIRMAN. I wonder if we could interrupt. I want to explain, because I do not want it to appear that members of this committee are running out on you, that we have been called before the Rules Committee on the poliomyelitis vaccination legislation which expires February 15 unless extended, and some of us are going to the Rules Committee, but we will return as soon as possible. Mr. PAXTON. I am sorry, and I understand, sir. In my opinion this bill, H. R. 8275, is the most desirable of those which I have studied. I believe it will combine maximum safeguards for public health with minimum surrender of economic freedoms, without discouraging continued scientific progress in nutrition and in food technology to promote greater variety and wider distribution of foods for the consuming public. I should like to direct my testimony principally to an analysis of the more important aspects of the bill and to a statement of the considerations which have led me to the foregoing conclusions. The bill would amend the Food, Drug, and Cosmetic Act and is therefore tailored to fit into the pattern of the act. At the outset the most important question is the coverage of the amendments, which necessarily leads to a definition of the substances or additives which will become subject thereto. Under this bill a "new food additive" is, in effect, defined in section 1 to mean any substance used for any purpose in manufacturing, processing, packaging, holding, or transporting any food which thus becomes or could reasonably be expected to become a component of such food, with the following exceptions: Exception 1: A substance which is generally recognized by qualified experts to be safe for use in foods under the conditions of its use or intended use. This general exception would include many additives which have long been used and are generally recognized to be safe. As noncontroversial examples, I would suggest salt, or flavoring extracts of the kind used by our grandmothers, or sodium bicarbonate as used in baking soda.. I might say at this point that all of the bills that I have seen which have ever been written on this subject have had a general exception for substances generally recognized by the experts to be safe. This bill has substantially the same type of exception in that respect as all of the other bills. Exception 2: Pesticide chemicals in or on raw agricultural commodities. Such additives are now subject to control under the special provisions of the Miller amendment to the act, approved July 22, 1954, and are therefore excepted. Exception 3: Any substance to the extent to which prior to January 1, 1956, it was approved or authorized for use in food by a Federal agency or official under any applicable law or regulation. This gets into the question of the grandfather clause of which there was some discussion yesterday. FEDERAL FOOD, DRUG, AND COSMETIC ACT 67 Examples are substances approved prior to January 1, 1956, by the Meat Inspection Branch of the United States Department of Agriculture for use in curing or preparing meat or meat products. Exception 4: Any substance approved for use in or on a food by or under the Federal Food, Drug, and Cosmetic Act. Examples are additives required or permitted in a food for which a definition and standard of identity is promulgated by the Food and Drug Administration, or coal-tar colors approved by FDA pursuant to section 406 (b) of the act. No doubt many additives falling within the first exception, that is, the general exception of long recognition of safety, will also fall within the third and fourth, and vice versa, but the three classifications are not necessarily synonymous. It would not seem necessary to subject to the controls of the proposed amendments any food additive which has heretofore been approved for use by the Food and Drug Administration or by another Federal agency and has therefore passed Federal safety tests. Nor would it seem desirable so to do, since the task of passing on the safety of additives now in use as well as new additives hereafter proposed will undoubtedly tax the capacity of FDA for a substantial period of time. Any additive not falling within one of the foregoing exceptions would come within the definition of “new food additive" and would therefore be subject to the proposed amendments. This means that some additives now in use would have to be discontinued unless and until adequate pretesting data thereon are submitted to the Food and Drug Administration and it has had an opportunity to evaluate the same. In this respect the bill is drastic. There is a substantial body of opinion in favor of exempting all additives in use prior to a specified date, which opinion was initially shared by some members and representatives of some of the food industries now supporting this bill, and it may be conceded that some fairly strong arguments can be advanced in support of that position. Mr. DIES. May I interrupt the witness right there, and I hate to do it. But I want to clarify this. There was testimony yesterday that in one of the bills there is a provision that where there exists a reasonable doubt with respect to any of these additives that are exempt, as to that chemical, there must be pretesting. Now, what is your idea about that sort of an approach to this Mr. PAXTON. That exception, in that particular bill, I do not quite understand. I have not been able to distinguish it from the first exception that I have described here. Here, our first exception would only apply to an additive which is generally recognized by experts qualified to judge the safety of foods to be safe. Mr. DIES. I think that there is a difference there. This would give the Food and Drug Administration the right to declare that a certain chemical, although exempted, that there is a reasonable doubt with respect to that chemical. Then, when they have so ordered that, it becomes obligatory upon the manufacturer to comply with the pretesting regulations. I think that is the difference in the thing. You lodge a power there in the Food and Drug Administration. Mr. PAXTON. Is that the Delaney bill, so-called? Mr. DIES. No; it was not in the Delaney bill, I do not believe. I believe it was in Dr. Miller's bill. It was in one of the bills, and it 68 FEDERAL FOOD, DRUG, AND COSMETIC ACT frankly appealed to me because we ought to relieve these manufacturers and processors of as many burdens, unnecessary burdens, as possible. They have enough Federal redtape to comply with as it is to transact their business and we ought to try to relieve them of it, if possible, and still we ought to give large power in the Food and Drug Administration to protect, of course, the health of our people. Mr. PAXTON. You are right. That is in the bill introduced by Congressman Miller, H. R. 8748. As I read it, there are two exceptions that run very close to each other in that definition. The first one is that the term "new food additive" shall apply to any substancewhich is not recognized among experts qualified by scientific training and experi ence to evaluate the safety of food, to be safe for us under the conditions of such use or intended use. That, I think, up to that point is a quotation, or virtually a quotation from our definitions. Mr. DIES. That is right. Mr. PAXTON. Then it goes ahead and says: The term does not include a pesticide chemical or a food additive in use prior to January 1, 1956, which presents no reasonable probability of injury to health. Now, to my mind that means just about the same thing as the first general exception. I do not see any language, here or elsewhere, in this bill, H. R. 8748, that would give the Food and Drug Administration the power to say this particular substance which you are using does not meet either one of these tests and therefore you must bring it in. I do not think they would have any more power to do that under this language than they would have under our language. Mr. DIES. I did not read the bill, but he testified yesterday-and I asked him specifically what the procedure would be under his bill— that if the Food and Drug Administration decided that as to some chemical which came under the general exception, there was a reasonable doubt about the use of it, they could require a pretesting of that chemical even though it was exenipt in general terins. I have not read the bill to analyze it, but that was his explanation of it. That appealed to me as a pretty sound approach. Mr. PAXTON. There may be some provision in his bill that enables the Secretary to initiate a proceeding to require the submission of pretesting data. Mr. DIES. Do you not think that there ought to be some provision? Suppose that you exempt all of these recognized chemicals that have been in use. Ought there still not to be some power somewhere SO that if the Food and Drug Administration developed a reasonable doubt about one of them they could come in and require pretesting of that substance? Would not that be a safeguard that would help the bill? Mr. Paxton. In that case I would think, under either definition. the one in our bill, or the one in Congressman Miller's bill, the user of the additive would have a right to a determination of the basic question of whether or not that substance is exempt under the definition. Mr. DIES. Suppose it is exempt-and there is no question but that it is exempt-do you not think that there should be some evidence developed when there is a question about it? Do you not think that there should be some power in the Food and Drug Administration for them to come in and say, "Now, that is true under the general FEDERAL FOOD, DRUG, AND COSMETIC ACT 67 Examples are substances approved prior to January 1, 1956, by the Meat Inspection Branch of the United States Department of Agriculture for use in curing or preparing meat or meat products. Exception 4: Any substance approved for use in or on a food by or under the Federal Food, Drug, and Cosmetic Act. Examples are additives required or permitted in a food for which a definition and standard of identity is promulgated by the Food and Drug Administration, or coal-tar colors approved by FDA pursuant to section 406 (b) of the act. No doubt many additives falling within the first exception, that is, the general exception of long recognition of safety, will also fall within the third and fourth, and vice versa, but the three classifications are not necessarily synonymous. It would not seem necessary to subject to the controls of the proposed amendments any food additive which has heretofore been approved for use by the Food and Drug Administration or by another Federal agency and has therefore passed Federal safety tests. Nor would it seem desirable so to do, since the task of passing on the safety of additives now in use as well as new additives hereafter proposed will undoubtedly tax the capacity of FDA for a substantial period of time. Any additive not falling within one of the foregoing exceptions would come within the definition of "new food additive" and would therefore be subject to the proposed amendments. This means that some additives now in use would have to be discontinued unless and until adequate pretesting data thereon are submitted to the Food and Drug Administration and it has had an opportunity to evaluate the same. In this respect the bill is drastic. There is a substantial body of opinion in favor of exempting all additives in use prior to a specified date, which opinion was initially shared by some members and representatives of some of the food industries now supporting this bill, and it may be conceded that some fairly strong arguments can be advanced in support of that position. Mr. DIES. May I interrupt the witness right there, and I hate to do it. But I want to clarify this. There was testimony yesterday that in one of the bills there is a provision that where there exists a reasonable doubt with respect to any of these additives that are exempt, as to that chemical, there must be pretesting. Now, what is your idea about that sort of an approach to this Mr. PAXTON. That exception, in that particular bill, I do not quite understand. I have not been able to distinguish it from the first exception that I have described here. Here, our first exception would only apply to an additive which is generally recognized by experts qualified to judge the safety of foods to be safe. Mr. DIES. I think that there is a difference there. This would give the Food and Drug Administration the right to declare that a certain chemical, although exempted, that there is a reasonable doubt with respect to that chemical. Then, when they have so ordered that, it becomes obligatory upon the manufacturer to comply with the pretesting regulations. I think that is the difference in the thing. You lodge a power there in the Food and Drug Administration. Mr. PAXTON. Is that the Delaney bill, so-called? Mr. DIES. No; it was not in the Delaney bill, I do not believe. I believe it was in Dr. Miller's bill. It was in one of the bills, and it 68 FEDERAL FOOD, DRUG, AND COSMETIC ACT frankly appealed to me because we ought to relieve these manufacturers and processors of as many burdens, unnecessary burdens, as possible. They have enough Federal redtape to comply with as it is to transact their business and we ought to try to relieve them of it, if possible, and still we ought to give large power in the Food and Drug Administration to protect, of course, the health of our people. Mr. PAXTON. You are right. That is in the bill introduced by Congressman Miller, H. R. 8748. As I read it, there are two exceptions that run very close to each other in that definition. The first one is that the term "new food additive” shall apply to any substance which is not recognized among experts qualified by scientific training and experi ence to evaluate the safety of food, to be safe for us under the conditions of such use or intended use. That, I think, up to that point is a quotation, or virtually a quotation from our definitions. Mr. DIES. That is right. Mr. PAXTON. Then it goes ahead and says: The term does not include a pesticide chemical or a food additive in use prior to January 1, 1956, which presents no reasonable probability of injury to health. Now, to my mind that means just about the same thing as the first general exception. I do not see any language, here or elsewhere, in this bill, H. R. 8748, that would give the Food and Drug Administration the power to say this particular substance which you are using does not meet either one of these tests and therefore you must bring it in. I do not think they would have any more power to do that under this language than they would have under our language. Mr. DIES. I did not read the bill, but he testified yesterday—and I asked him specifically what the procedure would be under his bill— that if the Food and Drug Administration decided that as to some chemical which came under the general exception, there was a reasonable doubt about the use of it, they could require a pretesting of that chemical even though it was exenipt in general terins. I have not read the bill to analyze it, but that was his explanation of it. That appealed to me as a pretty sound approach. Mr. PAXTON. There may be some provision in his bill that enables the Secretary to initiate a proceeding to require the submission of pretesting data. Mr. Dies. Do you not think that there ought to be some provision? Suppose that you exempt all of these recognized chemicals that have been in use. Ought there still not to be some power somewhere so that if the Food and Drug Administration developed a reasonable doubt about one of them they could come in and require pretesting of that substance? Would not that be a safeguard that would help the bill? Mr. PAXTON. In that case I would think, under either definition. the one in our bill, or the one in Congressman Miller's bill, the user of the additive would have a right to a determination of the basic question of whether or not that substance is exempt under the definition. Mr. DIES. Suppose it is exempt-and there is no question but that it is exempt-do you not think that there should be some evidence developed when there is a question about it? Do you not think that there should be some power in the Food and Drug Administration for them to come in and say, "Now, that is true under the general |