Mr. Russo. If you are not able to deal with sweeteners now, why not postpone the regulation until you can? What is the reason for all the urgency?

Mr. QUINN. Sweeteners have been required to be declared on bakery products except for standardized products by their common or usual name since 1938. There wasn't any mention of sweeteners in those TC's at all. Sugar is required to be sugar and corn syrup defined as corn syrup since 1938.

The only thing we did for standardized bakery products was at one time we said you didn't have to declare optional ingredients in standardized products like bread. We have now removed this exemption so bread labels have to declare optional ingredients like other foods such as candy.

So, really, there was no change in that particular regulation as far as sugar in foods in general. We merely removed an exemption applied to bakery products that didn't apply to other foods.

Mr. Russo. What is the urgency?

Mr. QUINN. We were trying to remove this exemption from all standardized foods so ingredients would be declared in standardized foods the same as in nonstandardized foods. Bread is one of many.

Mr. Russo. Is there a safety and health reason for this change? On what basis are you making this change?

Mr. QUINN. The same thing we did with the rest, so people could be aware of what the ingredient was in there.

For example, in ice cream, as mentioned earlier, somebody was actually damaged by not knowing there was a particular ingredient in it. There are people who wish to avoid sugar as such. They want to know what sweetener is in there so if they don't want to eat sugar, they don't have to. There are people who are allergic to anything you

want to name.

Mr. Russo. I guess there will come a time when the Government will run every phase of our lives. I guess that is what we are coming to.

In the Commerce Business Daily on July 28, I notice you are looking for an organization to do a widespread labeling investigation. Do you know how much this will cost, and do you contract out a lot? Dr. ROBERTS. I don't recall the estimated cost. We could determine that for the record.

Mr. Russo. Would you furnish that for the record? [The information follows:]

SOLICITATION BY FDA FOR SURVEY OF FOOD LABELING

Attached is a copy of the solicitation that appeared in the Commerce Business Daily for July 26, 1977. The contract has not yet been awarded. It is estimated that the cost of the services is approximately $60,000.

H-Research oriented surveillance of food labeling-Resumes are sought organizations having specific capabilities, facilities and willingness to conduct an intensive survey of food labeling. The FDA knows of only one source, the A.C. Nielsen Co., Northbrook, Ill., who can provide these services.

1. The Contractor must have (a) the ability and willingness to furnish data on dollar volume and case sales volume of all packaged brands of food products sold through warehouses systems; (b) the ability to furnish the same information on all other "store delivered" food brands other than fresh baked goods, fresh dairy products and frozen desserts; and (c) the ability to purchase any brand of food sold in the U.S. and deliver it to the Bureau of Foods upon request. 2. Under the proposed contract, the Contractor will be expected to: (a) Pick

26-915 - 78 - 12

up, purchase and deliver to the FDA approximately 1200 food products to be specified by the FDA technical representative. (b) Conduct a surveillance of canned fruit and vegetables for drained weight and fill-weight purposes. A sample of 3600 cans will be purchased which represent 12 brands per com modity in 10 fruit and vegetable commodities. Thirty (30) cans per brand (6 lots of 5 cans each) will be purchased. The brands will be specified by the FDA technical representative and this survey will be conducted twice. (c) Purchase all brands of milk, bread and ice cream in two chains and one independent store in seven geographically spread large metropolitan areas. Approximately 1500 brands may have to be purchased. (d) Based upon the data furnished under Paragraph 1 above, conduct an in-depth intensive surveillance of dietetic food categories to determine the adequacy of the labeling of these products, the extent to which these products are in compliance with FDA regulations and to determine whether changes or additions to current regulations appear to be appropriate. (e) The Contractor will be required to provide data on the dietetic food categories and the canned fruit and vegetable categories in a directory form as well as on tape. The FDA will analyze the data and issue instructions to the Contractor regarding the purchasing of the food products.

3. Organizations having demonstrated capabilities and experience in the specific areas mentioned above and desiring consideration for "Request for Proposals" are invited to submit a concise but complete resume describing: (a) organization background and experience; (b) qualification and experience of the personnel which would be assigned to the project with delineation of the technical and administrative responsibilities; and (c) facilities which would be utilized.

4. Unnecessary elaborate brochures or other presentations of a general nature beyond that sufficient to provide the information called for herein are neither required nor desired. This synopsis is not a request for proposal. Responses must be submitted in 4 copies no later than 10 days from the date of this publication.

The Government does not intend to award a contract on the basis of this request for research sources, or to otherwise pay for the information solicited. Responses should be directed to Negotiated Contracts Br., Attn: R. Gjolstad, Room 5B37, (tel: 301/443-4460). (P202)

Dr. ROBERTS. As to contracting out a lot, I don't know how to assess that. Our last year's contract program, as I vaguely recall, was between $3 and $4 million total for the foods area. Is that roughly correct? That is relative to a total agency foods budget of a little over $70 million.

Mr. Russo. Usually there is a trace amount of malted barley flour added to wheat flour at some mills. That has to be listed on a bread label, if I am not mistaken. Yet there is less than 2 parts in 1,000. Do you think that is proper? Does that help the consumer?

Dr. ROBERTS. Again, if a case could be made for exemption in that particular case, we would entertain it. I can't answer your question offhand.

Mr. Russo. So the burden is on the person who puts the ingredient in, to show the ingredient should be exempted, is that the way it is written?

Dr. ROBERTS. Essentially.

Mr. TOPPING. You have indicated your primary concern is with the ingredients in the product. Now, when we had the hearing with the bakers represented here, testimony was given by one of the witnesses that the bakers would provide the retailers a list of the ingredients in their products as you specify and the retailers could then provide the list to the consumers that requested it. Would that not meet your objective?

Mr. QUINN. Well, the law, the Federal Food, Drug, and Cosmetic Act, calls for it being on the label. We can make an exemption, but

why should we make an exemption for bakery products when we are not doing it for ice cream or anything else sold to the consumer?

It has been our opinion that the consumers want to be able to pick up the package without having to go ask somebody what is in it. We have had correspondence in that respect, and it is hard to make a case on why we should treat bakery products different than other prod

ucts.

Mr. HILE. The concept might be impractical with the total number of different kinds of pieces of paper the retailer would have to have available to handle that kind of program.

Mr. TOPPING. One other question. You mentioned this George Washington University law students' organization, and they seemed to have had an impact on you in issuing the regulation. What is the background of that group? Is that still an organized effort? I would like to get more information about them and what impact they had on you.

Dr. ROBERTS. The point of including that was just one example of a proposal. I should point out that we rejected that proposal. My point in using it in the testimony was that even though this was a proposal which we clearly were not permitted by the act to implement, that proposal still drew 4,000 comments. Those comments consistently endorsed the idea of more ingredient information, not only by ingredient name, but by percentage of ingredients.

Mr. TOPPING. Just one more if I may. You did not make an impact study, you say. This regulation is having a tremendous impact on the small bakers particularly. Some of them may have to close their businesses as a result of the labeling requirement. Why did you not make an impact study?

Mr. HILE. Well, the very technical response to that is that at the time the proposal was published we were not required by executive order to make the formalized economic impact assessment. That is not to say we are not always conscious of and concerned about the economic impact of what we do in the way of issuance of regulations. But there was no formal economic impact assessment made because at the time the proposal was issued, that was not required.

Mr. Russo. Would you consider doing an impact study before you issue regulations?

Mr. HILE. Clearly now we do in all cases, Mr. Chairman.

Mr. LYNCH. From your statement you apparently are proposing some type of relief from the pressure of the impending regulation. Does this mean that the bakers, until the regulation comes out, can cease getting those new labels ready?

Dr. ROBERTS. Our proposal will address alternatives and will also provide some relief from the impending compliance date. I would certainly encourage focusing on that proposal and relating favorably or unfavorably to it.

Mr. LYNCH. How soon will that proposal be ready?

Dr. ROBERTS. The sooner, the better.

Mr. Russo. I am sure we all agree with that statement.

Mr. FOWLER. Can't we do a little better than that?

If we are going to have all these hearings, are we going to look for it in 2 weeks, 1 month, Thanksgiving?

Dr. ROBERTS. Perhaps tongue-in-cheek. We are in the process of participating in four hearings in the last 2 days, and with Congress adjourning on Friday, we will have time after that to get back to business.

Mr. FOWLER. So we might anticipate Labor Day that we might have a copy of the proposal?

Dr. ROBERTS. We are anxious to get that out because we realize the impending compliance date and what that implies.

Mr. Russo. That is what is called the dodge. [Laughter.]

I can understand part of the reason for that. How much would a year's delay affect this proposal?

Dr. ROBERTS. I am not sure I understand your question.

Mr. Russo. If we were to ask Dr. Kennedy to put off the proposed regulation for 1 year-is there an urgent reason that it has to go into effect January 1, 1978. Can we ask that it be put off until January 1, 1979, to give us more time?

Dr. ROBERTS. Are you referring specifically to the baking industry? Mr. Russo. Yes.

Dr. ROBERTS. Obviously that doesn't have great health aspects or any of those kinds of problems with it. I think the only thing wrong with that is the move that we have been trying to make since about 1970 to move toward more and fuller labeling of foods.

Mr. Russo. Let me tell you what I am going to do. I am going to write a letter to Dr. Kennedy asking that the regulation be put off for awhile, so this subcommittee can call in the consumer groups and possibly Dr. Kennedy in 1978. We don't have time to do that this year.

You may tell him ahead of time that the letter is coming, and if this doesn't affect the health and safety factors, I don't see why we can't put it off while the subcommittee does a little more investigation. Dr. ROBERTS. I will alert the boss.

Mr. LYNCH. I wanted to clarify one thing. You are not saying the bakers are refusing to give this information to the consumer? Dr. ROBERTS. No, not at all.

Mr. LYNCH. Do you have any idea how much the average 1-pound loaf of white bread would go up in price as a result of that regulation? Dr. ROBERTS. Outside of inflation, I hope that we would arrive at a labeling position where there would essentially be no impact on the cost.

Mr. LYNCH. Well, you would welcome documentation on this subject?

Dr. ROBERTS. Yes.

Mr. LYNCH. Will you issue an advisory letter concerning the January 1 date to make it clear, what has happened today, as far as the bakers are concerned? Also, you are going to come up with another proposal. Will you put that in writing so the bakers are notified?

Dr. ROBERTS. Are you asking that we announce our intentions to issue a proposal?

Mr. LYNCH. Yes, and inform the bakers that there will be a change, and that they will have some time.

Dr. ROBERTS. We would perhaps publish a notice of intent.

My difficulty is, when you say, "Let the bakers know." Who are the bakers? We have petitions from the American Baking Association. We

have had contacts with numerous individuals. I don't know who the bakers are.

Mr. LYNCH. What would be the matter with putting something in the Federal Register on what you have told us in your statement here, so these people aren't going on to prepare for January 1?

Dr. ROBERTS. That would perhaps be the mechanism to use.

Mr. LYNCH. There was an ABA petition on, I guess, August 1, 1977, which discusses the 1- and 2-percent levels and how this would affect labels, and I direct that to your attention.

Dr. ROBERTS. Fine.

Mr. Russo. Any other questions?

[No response.]

Mr. Russo. Thank you very much, gentlemen. We certainly appreciate your coming down here, and I hope you can take our message that we have laid out back to the Commissioner.

[Whereupon, at 11:40 a.m., the subcommittee adjourned, to reconvene subject to the call of the Chair.]