We are pleased to provide you with specific examples of equipment needed, at this time, to determine whether unauthorized ingredients are in imported products as well as the number of personnel authorized to operate the equipment listed below.

This instrument is used for rapid screening of alcohol beverage products for a variety of contaminants. It is needed to "profile" products to accumulate the data-base that will allow the laboratory to observe changes in products (i.e. to spot potential problems signaled by a change in character)

1

Mass Spectrometer

$285K

This instrument is more sensitive and specific than the CG/FTIR which is used as a screening instrument. The Mass Spectrometer provides the definitive identification upon which regulatory or legal action be taken against a product.

1

$100 (total) 2

These GCs are replacement units for the HQ and San Francisco lab's aging equipment. Gas-Chromatographs are the work-horses of any modern laboratory since they can do such a wide variety of analytical jobs. These instruments, which are in constant use, are in need of replacement.

Mr. MRAZEK. I would certainly hope that any lack of capability to determine answers to those kinds of questions is something that can be addressed by us through the appropriations process. I hope you do have at least all the physical plant and equipment to conduct the kind of testing and review that is required of you.

In regard to your discovery of the 75 contaminated wines, I understand through your appendix that the ATF conducted 200 special field inspections to sample for DEG and quickly discovered 75 additional wines that were contaminated with DEG. That is a pretty significant amount.

When you do a-when you conduct a process like this, do you go into a store and take a bottle of every foreign wine off the shelf and conduct a test on it?

Mr. DRAKE. No. There is a sampling process. For the one kind of sampling, the market basket sampling there is a scientific random sampling process that was developed. For what we were looking for here, we had names and regions in Germany and Austria and Italy, and we were looking for similar names, similar bottlers, similar regions so we were able to focus more on wines coming from the general region that the first wines came from.

Mr. MRAZEK. Are you saying you did that because you don't have the capability to test all the wines from these foreign countries that come into the United States?

Mr. DRAKE. That is an awful lot of wine that comes into the country and the ability to test that would be an overwhelming task, I believe.

Mr. MRAZEK. What you are saying is there may well be potentially other wines that weren't tested that conceivably present a problem?

Mr. DRAKE. That is possible.

Mr. MRAZEK. Let me clarify for the record in reference to a point, Mr. Chairman, that Mr. Drake brought up in regard to an article in the Wall Street Journal. I am not sure how I characterize the statement in the Wall Street Journal, but in the April 16, 1986, issue, it states that U.S. winemakers can legally use chemicals that help in fermenting and clarifying wine and in stabilizing its color and taste. Some of those commonly used are sulfiting agents, and sorbates which are preservatives and fish glue, which clears the wine.

Have you taken a look at sulfides?

Mr. DRAKE. Yes, sir; we have. We have a notice of proposed rulemaking that is going through the rulemaking process. We are again deferring in a way at least to the FDA. They also have a rulemaking process going through their process. Our target is to be about 30 to 45 days behind them when they come up with a decision, our decision will be totally compatible with their decision.

Mr. MRAZEK. Is that the only 1 of the 80 chemicals that you have concerns about that are presently utilized in production of domestic wine?

Mr. DRAKE. We have yellow dye No. 5, but I am not sure if that is used in wine or not, but that is allowed to be used on labels if it is labeled so the consumer is alerted to the fact it is there.

I would suspect on the other——

Mr. MRAZEK. Yellow dye No. 5 is not used in wine though, is it?

Mr. DRAKE. Some wines, it may be. It may be-in some of the flavored, cocktail kinds of wines, it may be used, but not in the dry red or dry white wine.

Mr. MRAZEK. That is good to know.

Mr. BARNARD. You better protect what you buy.

Mr. MRAZEK. In any event, I wanted to clarify that they are legally in use.

Mr. DRAKE. They are legally in use, all of them would have been on the GRAS list, generally recognized as safe, list of the FDA for

that purpose.

Mr. MRAZEK. We can discuss that at a later time.

Thank you very much, Mr. Drake.

Thank you, Mr. Chairman.

Mr. HORTON. Mr. Chairman, I have one other question.

Mr. BARNARD. Mr. Horton.

Mr. HORTON. As I understand it, under the OMB procedures, your testimony was submitted to FDA and was reviewed by them. Did they make any changes or deletions in it?

Mr. DRAKE. OMB, sir?

Mr. HORTON. No; FDA.

Mr. DRAKE. No; FDA did not. We did that not under OMB procedure. We did that because we work together. FDA and ATF work together. It did have to be submitted to OMB, my testimony had to go through OMB, but not FDA to my knowledge. Our exchange between ATF and FDA was because we worked together.

Mr. HORTON. Did you submit it to OMB?

Mr. DRAKE. Yes, sir.

Mr. HORTON. Did they make any changes?

Mr. DRAKE. I believe there were some changes made, yes.

Mr. HORTON. Can you tell us what those changes were?

Mr. DRAKE. I think most of them were kind of editorial changes. Mr. HORTON. Editorial, but not substantive?

Mr. DRAKE. We may have said limited resources and we were asked to put that in as "available" resources, rather than limited. Mr. HORTON. What you might call technical changes.

Mr. DRAKE. Yes, sir.

Mr. HORTON. Nothing in the way of substance?

Mr. DRAKE. Oh, no, nothing.

Mr. BARNARD. Technical changes?

Mr. DRAKE. Well, yes, not technical, but these were editorial changes that OMB preferred to make.

Mr. BARNARD. Why would they want to make editorial changes? Why would OMB want to do that?

Mr. DRAKE. You would have to ask OMB, Mr. Chairman.

Mr. BARNARD. I just can't quite understand that, except are they trying to hide something?

Mr. DRAKE. They did not in the changes they made. Not in the changes they made.

Mr. BARNARD. But they made editorial changes from the standpoint of whether or not you had limited resources?

Mr. DRAKE. Yes, sir.

Mr. BARNARD. They are not trying to keep you from accurately testifying as to whether you have adequate resources?

Mr. DRAKE. No, sir.

Mr. BARNARD. It appears to me they are.

Mr. DRAKE. That wasn't the message I got.

Mr. BARNARD. Naturally. You work for them. We don't, but we see this all along the line, Mr. Drake. This committee has done hearings on textile imports, steel imports, and now wine imports and here we are. We have a very sad, very sad experience with the number of Customs agents working-very bad experience with the number of Customs agents working in the field trying to help control imports and what happens? They cut down on the number of Customs inspectors. If that is wise use of manpower-I don't see it. So I make that editorial comment.

Thank you.

Mr. DRAKE. I appreciate that.

Mr. BARNARD. We appreciate having you with us today.

Mr. Drake, if you wouldn't mind, you and your associates, please stick around for a little while. We won't keep you pass your posting out time.

Mr. DRAKE. We don't have one, Mr. Chairman.

Mr. BARNARD. If you work overtime, we will see that OMB pays you. [Laughter.]

Our next witness will be Mr. John M. Taylor. Mr. Taylor is Director of the Office of Enforcement, Office of the Associate Commissioner for Regulatory Affairs, Food and Drug Administration. We welcome you to the podium today, Mr. Taylor, and I am sure you would like to identify your two associates, please.

Mr. TAYLOR. On my right is Robert Lake, Acting Director, Office of Compliance, Center for Food Safety and Applied Nutrition, and Curtis Coker, who is also in the Office of Compliance, Center for Food Safety and Applied Nutrition.

Mr. BARNARD. We welcome you to the witness table today, gentlemen, and we will hear from you at this time, Mr. Taylor.

Mr. TAYLOR. Thank you, Mr. Chairman.

Mr. BARNARD. Without objection, your entire testimony will be included in the record, and if you care to summarize, we will leave that up to your determination.

STATEMENT OF JOHN M. TAYLOR, DIRECTOR, OFFICE OF ENFORCEMENT, OFFICE OF THE ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY ROBERT LAKE, ACTING DIRECTOR, OFFICE OF COMPLIANCE, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, AND CURTIS COKER, OFFICE OF COMPLIANCE, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

Mr. TAYLOR. Thank you very much, Mr. Chairman and members of the subcommittee. I am here today to discuss with you the role of the Food and Drug Administration [FDA] in the regulation of imported wines. In response to your specific concerns, my_testimony will describe the assistance that we have provided to BATF in the removal of imported wines containing the industrial chemical diethylene glycol [DEG] upon discovery of this problem in July 1985.

In summary, FDA provided a health assessment while BATF engaged in a sampling and compliance program-a division of labor reflecting the role that each agency was best equipped to assume under those particular circumstances. FDA's health assessment indicated that while exposure to sufficient amounts of DEG from consuming contaminated wine could have serious health consequences, the actual likelihood of injury was low. Indeed, FDA is not aware of any reports of injury due to this problem.

FDA's responsibilities relating to the contents of wines as well as other alcoholic beverages derives from the fact that they are "foods" under the Federal Food, Drug, and Cosmetic [FDC] Act. From FDA's standpoint, foods such as imported wines may be marketed as long as they are not adulterated or misbranded as these terms are defined by the FDC Act.

One way in which wine may be adulterated is by containing an unapproved food additive. Food additives, which are substances that are intended or expected to become components of food or otherwise affect the characteristics of food, must be approved by FDA before they may be lawfully added to a product such as wine. The presence of an unapproved food additive, such as the use of DEG to sweeten wine, automatically renders a food adulterated.

Under these circumstances, FDA could have monitored incoming shipments of wine and detained those shipments contaminated with DEG. FDA also could have tested on a lot-by-lot basis Austrian wines that had already been imported and seized those lots found to contain DEG. As I will explain below, however, neither of these options could have been exercised as efficiently as BATF's authority under the Federal Alcohol Administration Act.

It is incumbent upon the two agencies, therefore, to work together whenever a problem arises within this area of shared jurisdiction to ensure that their collective resources, both scientific and enforcement-related, are utilized in the most appropriate and effective way to solve the problem. Although no formal or written agreement exists between the two agencies, I am pleased to report that when faced with a problem involving shared jurisdiction, FDA and BATF have been able to divide scientific and enforcement responsibilities and perform their respective roles quickly. Later in my testimony, I will address the factors that govern this relationship and how they have been applied in the case of DEG and in other cases as well.

First, however, I would like to describe briefly FDA's import monitoring problem, its rationale, and the extent to which wines fit into this program. The variety and volume of imported processed foods and raw agricultural commodities that enter the United States every year is quite substantial. FDA conducts an import monitoring program, in addition to its surveillance of domestically produced commodities, that focuses primarily on pesticide residues on raw agricultural commodities. FDA also examines foods for a number of industrial chemicals that have been identified as potential food contaminants.

FDA's monitoring for chemical contaminants in food is geared primarily to detecting a vast array of chemicals that may occur as residues in foods from agricultural use or environmental sources. From a practical standpoint, it would be impossible to test for all