The CHAIRMAN. What would be the difference of transferring it from one place in the proposed bill to another!

Mr. SCHRAMM. Really, under section 5 this becomes one of the several items which the Secretary must consider in determining safety, and it would permit him, in the light of changing knowledge on the subject of safety, on cancer in particular, to change his reference point or requirements without the necessity of taking it through a legislative change which would be a saving of time.

The CHAIRMAN. Would it be correct to say in the proposed language in the House bill as it is now, it specifically provides that a color additive shall not be listed, and so forth and so on, and what you propose is that in determining whether a proposed use of a color additive is safe, the Secretary shall consider, among other things, relevant facts he shall consider this same language.

As I gather it, the legal import of that is that the Secretary may use his discretion as to whether these things being present it shall be delisted. In the bill, it is mandatory.

Mr. SCHRAMM. Exactly, Mr. Chairman. And in that case

The CHAIRMAN. In other words, what you do here I want to get this clear, because this is pretty important to the whole thing is to say that if these conditions are found to exist, the discretion is left to the secretary as to whether or not that shall be lifted?

Mr. SCHRAMM. Exactly. That is right.

The CHAIRMAN. And in the bill, if these conditions are found to exist, then the Congress says that they shall not be listed. The Congress says so instead of the Secretary-that is the difference?

Mr. SCHRAMM. Yes, sir.

The CHAIRMAN. The way the Secretary talked yesterday, I do not think that there would be any difference in the results.

Mr. SCHRAMM. I am sure with the present state of knowledge, the results would be different.

The CHAIRMAN. Some of the Members of Congress and I am sure that there are a good many of them-would contend, and appropriately so, that it should not be left to the Secretary, but to the Congress. We may never know just what the position of the next Secretary or the next Congress may be..

Mr. SCHRAMM. From my experience over 20 years with the Food and Drug Administration, and the excellence of the scientific personnel they have, I am sure that a situation of that kind would not be allowed to persist very long.

The CHAIRMAN. This matter that we are talking about is just for clarification.

In the position that the industry takes, they will have to make up their mind whether they want any legislation at all, if this provision is to be included where it is now.

Mr. SCHRAMM. With respect to this specific problem of cancer, which we are all discussing now, we feel that in the Senate bill as it is now worded, the Secretary has implicit authority to terminate the use of anything about which he has that to show that the development of cancer in either man or animal may be possible by considerable testing conditions.

As we pointed out later in our dissertation here, if it is preferable to actually put the words, involving cancer, into the law, we feel that

for expediting it and coping with the rapidly changing science, with the latest scientific knowledge, that the Secretary could then act on the basis of the scientific knowledge existing at that time.

As I recall, Secretary Flemming indicated yesterday that should cancer experts, toxicologists, scientists, at some future date agree that tolerances can be established for carcinogens, that there are measurable threshold quantities under which no harm would likely ensue, that then he would be perfectly willing to establish a tolerance, but with the Delaney clause in the position where it is in the House bill, it would require that he bring this to the attention of the Congress, so that suitable legislation be enacted to permit him to do something that he would be able to do immediately under the requirements that would merely shift it to the other section of the law, the discretionary section.

The CHAIRMAN. I understand that. We are faced with a practical situation. We have had the same problem before.

I know about the difficulties we had before.

Thank you very much for your presentation, gentlemen, and the contribution that you have made to this problem.

Mr. SCHRAMM. Thank you, sir.

The CHAIRMAN. The committee will recess until 2:30 o'clock this afternoon, at which time Mr. Riley, legislative representative of the AFL-CIO will be the first witness.

(Whereupon, at 12:30 p.m., the committee recessed, to reconvene at 2:30 p.m. the same day.)

AFTERNOON SESSION 、

Mr. ROBERTS (presiding). We will proceed with the hearings. The committee will please be in order.

Our next witness will be Mr. George D. Riley, legislatice representative of the AFL-CIO. We are glad to have you here.

STATEMENT OF GEORGE D. RILEY, LEGISLATIVE REPRESENTATIVE, AFL-CIO, WASHINGTON, D.C.

Mr. RILEY. Mr. Chairman and members, I have a prepared statement which I have submitted to the clerk, and I ask that it be inserted into the record, and then I have a few informal remarks that I want to give, with your indulgence.

Mr. ROBERTS. Without objection, your statement will be made a part of the record at this point, and you may proceed as you desire.

(The prepared statement of Mr. George D. Riley is as follows:)

STATEMENT OF GEORGE D. RILEY, AFL-CIO Legislative ReprESENTATIVE, ON H.R. 7624. BEFORE THE HOUSE INTERSTATE AND FOREIGN COMMERCE COMMITTEE, COLOR ADDITIVE AMENDMENTS OF 1959

The AFL-CIO, representing the largest grouping of consumers, offers its views on H.R. 7624, a bill to protect the public health by amending the Federal Food, Drug, and Cosmetic Act. We support the bill as introduced.

We believe that the measure will further strengthen the basic act if approved in its present form. For this reason, we oppose any amendments which will have the effect of delaying the work of the Food and Drug Administration in pursuing its appointed duties.

Inclusion of coal tar colors under the legislation is especially important in our evaluation of the merits of H.R. 7624. The fact that a color on the list

can be used without restriction, we also regard as a vital topic covered in the legislation.

We can well understand the impatience of some processors who feel that they are being hindered to the advantage of some competitor who likewise is determined to “get there first with the most."

As far as consumers are concerned, if there be less haste and urgency and if the American public is to have ample protection, then its welfare is the prime consideration and the first concern ahead of profits.

In this connection, that portion of the statement which was included with this bill at the time it was submitted to the Congress in 1959 is good language and is entitled to reference at this point:

"There is no justification, from the point of view of the public interest, in driving either color manufacturers or food, drug, or cosmetic producers, dependent upon the use of color, out of business where the particular use of color involved is one which can safely be admitted under proper conditions of use (including tolerance limitations and certification requirements) established by this Department.

"Hence, while, as a consumer protection agency, we are concerned first and foremost with the protection of consumer interests, equity to the commercial interests concerned is also a factor in the submission of this proposal. It should, however, be stressed in this connection that we could not agree to a dilution or relaxation of the limitations of the carefully designed transitional provisions of this bill with respect to color additives which have heretofore been in commercial use."

The above quoted language is sufficient to express our own interest in this legislation with reference to the Food and Drug Administration which is primarily a "consumer protection agency." We underscore the further statement that we are, as is the FDA, concerned and foremost with the protection of consumer interest.

I am sure the commercial interests' side of the discussion is sufficiently vocal and strong enough to get maximum protection to which they feel they are entitle:.

Of especial concern is our interest in the so-called Delaney provision which occurs on page 10 of the printed version of the bill starting on line 11. This portion of the measure is paramount in our estimation. As will be noted, this safeguard of the American public's well-being was not included in the Senate bill. S. 2197, as passed.

Reviewing the statement of the American Cancer Society, Inc., of July 22, 1957, which is part of the record in your committee on the food additive legislation. I recall that it was stated that cancer claims the lives of a total of more than a quarter of a million American citizens each year. The society further remarked upon the inadequacy of legislation of that time and before the Delaney amendment was part of the enactment.

The Delaney amendment assumes further importance from the fact that it is a built-in feature of the Food Additive Act of 1958. For it to fail of continued inclusion in H.R. 7624 would be to apply this anticancer protection to foods but not to coloring substances. We can see no reason for its applicability in one field and not others.

We also ask that appeals procedures move through established channels and not by the de novo process. The tried and true Administrative Practices Act and recourse to the record rather than moving into the courts on a completely fresh basis will assure uniformity and will be clearly in the direction of the American process.

It would appear to be a mistake so long as the whole burden of proof is upon Government to lay down the ground rules against the use of poisons or potential poisons and then permit industry to tie up the administrative machinery in a legal morass for 2 years and meanwhile be permitted to use the substance which is suspect. A lot of persons can be started down the road to earlier death through that means, commonsense certainly suggests.

Profits must not be permitted to have precedence over consumer interest. Be it remembered that every consumer less, also can injure profits just as surely. As we examine this bill and its provisions, we conclude that all dors now listed typically were included before present modern methods were devised. In this regard, the legislation would seem to divide the responsibility for compiling and maintaining the list between the Government and industry.

It further would seem that industry should welcome this opportunity to share a responsibility in constructively listing the colors which are clearest for use.

And

We regard retention of the Delaney amendment as probably the heart of the bill. There are those who would say that this amendment is rigid and harsh. We have supported this provision in the past and now renew that support. if it be harsh, it is harsh on the side of right and provides a periphery of defense against all who wittingly or otherwise would allow the human system to be subject to dire jeopardy.

We cannot urge too strongly that no modification of the Delaney proviso be considered or tolerated.

The bill principally provides these points:

(1) Allows Food and Drug Administration to establish tolerances for the amount of color permitted and further to specify those products in which it may be used.

(2) Industry will be required to prove its use of a color as safe.

(3) A listing of any color for use which would promote deception of the customer is forbidden.

(4) Use of any color causing cancer in man or animal is forbidden and differentiation is drawn between external and internal uses.

(5) Where desirable the Government is permitted to text and to certify individual lots of all color additives.

(6) The new color regulations are extended to colors extracted from vegetable and other natural sources as well as to coal tar dyes.

Color additives other than coal tar products now are under the new food additive amendment. There may have been informal discussions in some quarters on setting tolerances for coal tar derivatives. It is not easy to endorse such proposal for the simple reason that if such dyés are to be regarded as deleterious in large doses, certainly proportionately they must be looked upon as having a similar effect in small doses, though in reduced proportion.

The human system is an intricate chemistry plant. The fact that certain ailments, afflictions, and diseases, including cancer, continue to be great mysteries even to our most advanced and learned experts is sufficient demonstration that we can scarcely be warranted in condoning any components in any quantity large or small so long as they cannot pass the pretesting stage of the animal in the laboratory. One person's tolerance may well be low, another's high. Certainly, the Congress will not wish to attempt the task of setting tolerance against toxic matter for individuals.

Opportunity is taken on this occasion to commend the work of the Food and Drug Administration and Secretary Flemming for the forthright manner in which the Department and the bureau have acted, clearly consistent, in our viewpoint, with provisions of law in the field of food and color additives. They have carried on for the protection of the rights of all parties concerned, in our estimation.

We find no reason or purpose in weakening the law. This is the reason for our support of the bill as introduced.

It must be borne in mind that consumers have absolutely no control over the substances which go into their digestive systems.

The proposal has been made that a committee or panel of scientists discuss the virtues of this legislation. This approach can have its good points as well as points to the contrary. It will enable scientists who are friendly to the consumer to speak up.

In any event, we ask that a color additive bill be not permitted to form the groundwork for changing basic law. There will be plenty of battles to wage beyond the present stage, even with H.R. 7624 approved as written.

The recent situation created through the induction of pellets into poultry whose heads and necks later were found to affect mink is sufficient in itself to prove the justification for our statements in this regard. It is a sad commentary that when the welfare of minks is at stake, then we take another look at what goes into poultry as a second thought in its relationship to human consumption.

We conclude our case by calling for the bill to be reported in substantially its present form and with the suggestion that your committee will be doing a signal service in so reporting the bill.

Mr. RILEY. My name is George D. Riley and I am legislative representative of the AFL-CIO.

We favor the bill as introduced, in hopes that it will be reported in substantially the original form.

Mr. Avery yesterday wanted to know what consumer interests were represented here. We can respond by saying that we are the most numerous block of consumers, and as such we are actively concerned with what is being induced into the human systems of our members and their families.

We are definitely opposed to the use of any compound or colors which are not proved to be anticancer engendering.

The discussion of tolerances and tolerance dosages of cancer suspect substances is completely unimpressive, in our viewpoint. We do not believe that there can be any tolerance of cancer or its causes.

For that reason we consider the Delaney-Sullivan provision, which went into the Food Additives Act and which is in the present bill before your committee, the House bill, and which was eliminated from the Senate bill, S. 2197, is the heart of this proposed legislation.

As on other occasions, we are for the Delaney-Sullivan amendment as a minimum safeguard for you and us as consumers. We desire to call attention to that.

We oppose the Senate bill as offering not any more than a lessening of the present law, and which Senate amendments we regard as industry amendments. We ask that S. 2197 be ignored in its entirety.

H.R. 7624 seems to offer a working partnership to industry. We hope that industry takes due note of that, and takes the opportunity which I feel this bill is offering them as copartners in preserving their industry, the industry of feeding American citizens now and in the future generations.

We oppose any suggestion which can have as its results legalistic delays on a de novo basis, at the same time permitting continuing use of additives reposing under chemical clouds."

We remark that a breakthrough here means an effort to vitiate similar concepts in the food additive bill, and even if it did not, we then would have the situation of having it in one act and not in the other.

The urgency expressed by industry we feel is not the urgency of the consumer. If there be urgency, it must be better demonstrated as being in behalf of the human stomachs than the testimony that I have heard thus far on the part of the representatives of the dye or coloring industry.

We also oppose putting the anticancer rider on a permissive or discretionary basis.

In talking to Secretary Flemming the other day, I said substantially the same thing as the chairman said this morning, in opposing his discretion, the right to use the substance or not when it is suspect, we do so because we do not know who his successor will be and how long he will be around. We have faith in the present Secretary, but we do not know that the next one will be one that we will have faith in, who he will be. And that kind of discretion we do not think that the Congress should grant to any official, no matter who he may be.

We are not ready to settle for half a loaf in that regard, believe me. Mr. Chairman, that is about the extent of my remarks, unless there are any questions that I will be responsive to, if I can answer them. Mr. ROBERTS. Thank you, Mr. Riley.

I take it that it is the position of the AFL-CIO to heartily endorse the Delaney-Sullivan amendments? Mr. RILEY. Yes, sir.