manufacturers panel, poses the most serious threat to free enterprise and orderly government ever to be proposed in Congress?

Dr. EDWARDS. No, I do not.

Senator PERCY. Do you think that such statements are outrageous from responsible business groups?

Mr. HUTT. Can we take the fifth on that one? [Laughter.]

Senator PERCY. I think it is outrageous, and I deplore the fact that no business association would attach their name to the so-called business responsiveness kit. The Grocery Manufacturers Association denied that they had anything to do with it until pressed by my office, to admit their connection.

I just wanted you to be aware of this situation in case it had not come to your attention.

QUESTION OF CYCLAMATE BILL

Lastly, I would like to ask about the cyclamate bill which has passed the House and is before the Senate Judiciary Committee now. My own judgment is that this bill--and it does affect a very, very large laboratory which has world headquarters in Illinois leaving me with something of a conflict of interest-represents bad legislation which I am very much opposed to.

I think it is bad business. For those interested in it, I would like to ask your own personal judgment as to the wisdom of the Congress of the United States reimbursing companies who stayed in this business up until the FDA order was issued, taking into account that since 1951 there have been studies and public reports about the potential danger that existed in this field.

Dr. EDWARDS. Let me first say, Senator, that I think the organizations involved with cyclamates did have sufficient warning that the storm clouds were picking up long before they were banned.

The thing that concerns me is if the cyclamate indemnification bill were to pass and it would set any precedent, I think it would destroy the effectiveness of the Food and Drug Administration in terms of its regulatory activities.

Senator PERCY. In other words, when an investigation or study was being undertaken regarding a hazardous product and you realized that there would be $1 billion, or $100 million or $1 million of cost invested in a recall, it might possibly be a factor that someone in the agency would have to take into account and say, "Wait a minute, we had better hold off, because we are going to pay the bill?"

Wouldn't it be an encouragement to manufacturers, despite the fact that they have been warned since 1951 that cyclamates may cause birth defects, gene mutations and have other adverse effects, wouldn't it say to them, "Stay in full production until the last day, and the Government is going to come in and bail us out?"

Dr. EDWARDS. I think you are right. I think it would destroy the FDA regulatory activities.

GOVERNMENT AID WOULD BE SOUGHT BY ALL

Senator PERCY. If we passed the legislation, wouldn't it mean that producers of pesticides would likely say that taxpayers should indemnify them for their losses?

Dr. EDWARDS. I would like to have Bill Ruckelshaus answer that question, but I expect it would.

Senator PERCY. Or if factories are closed, or mines are closed, wouldn't the mine operators be coming in and saying the Government should bail them out because they had been injured by an act of Government?

Dr. EDWARDS. I think it would drastically affect regulation across the board, as far as we are concerned, and also in the Environmental Protection Agency and the Federal Trade Commission. All agencies would be involved.

Senator NELSON. Let me ask something.

Then how do you explain the administration's support of the bill? Senator PERCY. Mr. Chairman, I didn't yield for that question. [Laughter.]

I was trying to avoid it.

Dr. EDWARDS. You have to speak to others other than myself. Our position has been throughout, Senator, that if this were precedent setting, we obviously couldn't go along with it

Senator NELSON. You supported it on the grounds that it is not precedent setting?

Dr. EDWARDS. We didn't take a position one way or the other. Senator PERCY. Dr. Edwards, this brings me back to where I started. The chairman was not here but I think you have made an immense contribution in recent years. Your integrity has never wavered one bit, regardless of political pressure, and I wasn't surprised at all at your testimony today that you personally oppose the cyclamate bill, even though an official position has been taken.

There is a conflict, I think, within the administration on this. This is well-known, and the judgment of HEW was not accepted. There were other voices that spoke louder, apparently, but I just want you to know that for one-having a terrific conflict of interest with the largest manufacturer in my own State, and a great, great American company I just could not possibly in good conscience support this measure. I think it would be a travesty in view of my responsibility nationally if I took a parochial Illinois interest and said it was all right for them and then I voted against the SST and the Lockheed loan and all these other subsidies that would bail out bad management, when private enterprise can't finance it.

I commend your sticking to principle on this very, very important legislation, and I assure you that the bill wouldn't have had a chance anyway. I think it is just a bad bill in the first instance, and I wish that your voice had been listened to, because I think most of the Congress would be behind you on this one.

I thank you, Mr. Chairman, very much indeed for your indulgence.

RE-EXAMINE SAFETY OF HEXACHLOROPHENE

With respect to the hexachlorophene situations I mentioned yesterday, and I should mention again to you, your responsiveness to a simple letter of inquiry from me as to whether Bebe talcum powder

was available in the United States. You gave us a definitive answer in a very short time, absolutely not.

That product was 6.4 percent hexachlorophene and caused some 39 deaths over a brief period. I think it was a great reassurance.

But I do wonder whether my further request that we now reexamine the whole issue of hexachlorophene safety-whether that is nearing a decision, and will a decision be imminent?

Dr. EDWARDS. Yes, Senator, we have made our decision. We have a panel of outside experts who reviewed the whole subject of hexachlorophene this past weekend, and we will be announcing in the next few days-on Friday, to be exact-our specific recommendations.* Senator PERCY. Thank you very much indeed for that, and I won't inquire as to what your decision is.

Dr. EDWARDS. We appreciate your interest in the subject, believe

me.

Senator PERCY. I do want to thank your staff very much indeed. I have had the pleasure of working closely with Peter Hutt and Jerry Meyer has been extremely helpful in the hexachlorophene issue particularly. We have found your staff's testimony helpful today.

Dr. EDWARDS. Thank you, Mr. Chairman.

Senator NELSON. Thank you, Dr. Edwards. We appreciate your taking time to come.

Our next witness is Dr. Ira Somers, representing the National Canners Association.

STATEMENT OF DR. IRA SOMERS, EXECUTIVE VICE PRESIDENT, NATIONAL CANNERS ASSOCIATION

Senator NELSON. Dr. Somers, I am sorry we could not get to you sooner. Your statement will be printed in full in the record. You may present it however you wish. I understand you are prepared to make a summary of your statement.

Dr. SOMERS. Yes, sir; I am Ira Somers, executive vice president of the National Canners Association and also have the responsibility for the research laboratories of the association. As you have said, I will summarize my statement, but I want to make reference to a few excerpts and in those I hope the reporter will make the changes as I make them in the statement as I go through the text.

The National Canners Association appreciates this opportunity to appear before your committee in an effort to furnish information that will be helpful in developing national policy on the important subjects of food additives and nutrition.

Let me first direct your attention to a number of observations concerning bill S. 76, which is known as the Food Additive Act of 1971. It is designed to extend the Delaney clause to congenital deformities-teratogenesis-and genetic mutations-mutagenesis.

The Delaney clause now of course applies to induction of cancercarcinogenesis.

*See Appendix 1, p. 1323.

As a scientist, I would analyze the extension of the Delaney clause in the context of a basic biological concept; a concept that has already prompted scientists to indict the clause as it applies to carcinogenesis. Stated simply, in all biological systems we eventually come to what must be accepted as a no-effect level.

Mr. Chairman, there are few things touch our lives if applied or consumed in excess amounts would not have serious adverse effects. And I think Commissioner Edwards has adequately covered that subject, and brought out a number of examples which I think are pertinent as far as we are concerned.

URGE CAREFUL CONSIDERATION OF NO-EFFECT DOCTRINE

Mr. Chairman, in summarizing our position on S. 76 we respectfully request that the committee carefully consider the no-effect doctrine and allow research and reason to prevail in the interpretation of the effect of substances suspected of having an adverse reaction on the human organism.

Mr. Chairman, I would now like to direct my analysis to S. 3163, which is known as the Food Protection Act of 1972. It is our understanding that the bill has two main features:

1. Testing of food additives and

2. The modification of the Food and Drug Act to apply to nutritional standards and nutritional labeling.

Since food additives are not extensively used in the canning industry we will address our comments to the questions of nutrition standards and nutritional labeling.

And since the question of additives has been adequately covered by the Food and Drug Administration, I think we will not say more than that. I would like to preface this by two overviews, however, before dealing with the specific sections of the bill. First, under the direction of the Food and Drug Administration, a voluntary nutri tional labeling program is already being developed. Therefore, it is our opinion that mandatory legislation would appear to be inappropriate in that it would act to undermine the voluntary effort being initiated.

It is our belief that a voluntary program can be established and that this will work to the advantage of the consumer, but it should be based on a reasonable understanding and interpretation of nutritive values produced naturally by foods. This interpretation will be developed further in this testimony.

Secondly, in overview, there is ample evidence to show, that under the current system, good nutrition can and is being achieved by eating a balanced variety of presently available foods including those from

cans.

We had our home economist prepare typical 1-week menus including selections from canned foods wherever they might logically be used. I have tables* attached to my prepared statement which show the possibilities based on diets prepared by our home economists.

*See prepared statement, p. 1248.

Keeping the overviews in mind, I would like to turn our attention. to section 4(a) of the bill. Section 4(a) provides for an amendment to section 401 of the Food and Drug Act to permit FDA to draft "reasonable standards of nutritional value."

"REASONABLE STANDARD" LANGUAGE VAGUE

But exactly what is meant by a "reasonable standard"? We find this language to be vague and because of the far reaching implications of the section would offer the following interpretations for the committee's consideration.

If by reasonable standards, it is meant that every food would have to meet some minimal level, we would hope that it be set realistically to allow packing and distribution of all products as produced by nature. That is, of course, where most of our foods come from at the present time.

We have an abundance of evidence to show that the natural variations in nutritional levels of products are considerable depending upon factors totally outside the control of the food manufacturer and have included table III at the end of this statement showing what these variations are for a number of products.

We would emphasize that this wide variation in food composition of raw agricultural products is recognized by every qualified authority. For example, the factors affecting such variation have been comprehensively reviewed by Robert S. Harris and Harry Von Loesecke, "Nutritional Evaluation of Food Processing".*

The work opens with the following analysis: "The nutrient content of freshly harvested edible plants varies. Usually this variation is not more than severalfold, but on occasion it may exceed one hundred fold. These variations result from the interplay of a number of factors, chiefly genetics, location, season, soils, fertilization of soils and maturity.'

The report goes on to give numerous case studies of how environmental factors may affect nutrient content. But let me illustrate the point by referring to the relationship between the ascorbic acid content and the availability and intensity of sunhine.

The ascorbic acid content of turnip greens was reduced from 191 mg, to 128 mg. per 100 grams by differences in available sunshine. Reducing sunshine available to tomato plants by 25 percent reduced the ascorbic acid content from 26 to 16 mg. per 100 grams.

We would emphasize, Mr. Chairman, that virtually all of the factors mentioned are beyond the immediate control of the processor and in many respects, the canner is simply an agent of nature itself.

Thus, on the basis of the aforementioned analysis, it is our opinion, that a proposal that calls for the establishment of unclear standards, cannot be viewed as performing a significant service to the consumer.

Similarly, any proposed level of specific standards that would not allow for natural variation in nutritional levels would indeed place an unfair compliance burden on the food manufacturer.

John Wiley & Sons, 1960.