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ed out by BATF is there is no way unless we have some type of information that we would be able to test for all the possible illegal chemicals that could be put into wine.
Mr. BARNARD. So there is no testing of any wine products that come into the country at this time?
Mr. TAYLOR. Not on a routine basis, no.
Mr. BARNARD. Mr. Taylor, one of the reasons that you give in your testimony for deferring to the BATF is that they had better and more authority than you do for the same cases. And yet in their testimony, they concede that their authority has some very, very big gaps in order to require certain actions and reports. In retrospect, wasn't there some misunderstanding on FDA's part about the extent and amount of BATF's authority?
Mr. TAYLOR. I could say it was probably some misunderstanding on my part, because I was involved heavily in that decision.
Mr. BARNARD. In that case, shouldn't the FDA have been jointly involved in a regulatory capacity to fill in those gaps?
Mr. TAYLOR. Based upon what we knew at the time, I would say that what we did was primarily what we would do again. However, as I stated in my testimony, we are looking at the whole gamut of things that happened and we will be looking for ways to improve the performance in the future.
Mr. BARNARD. One of those ways could very possibly be sharing with them experience in a nationwide recall. Did you know that BATF had never conducted a nationwide recall at that time?
Mr. TAYLOR. No, I did not, but one of the problems we have, we do not have recall authority either and we can request a firm to recall but we do not have authority to force them to recall. That was one of the primary things in our decision regarding how would we get back all the wine that was in the domestic commerce.
Mr. BARNARD. The GAO indicated that the FDA was lacking resources at the time the decision was made to defer to BATF on the DEG contamination, and the FDA staff indicated that this played a role.
Could you give us a better feel for your staffing shortages in FDA offices that conduct tests and undertake recalls?
Mr. TAYLOR. I guess what was really told to the individual from GAO is that at the time of the problem with the DEG in the wine, we had a number of other emergencies. We had the soft cheese problem with Listeria that started in California and spread to some imported cheese, and so forth. At the same time we had the problem with the Aldicarb in watermelons which made a number of individuals ill. So we had two major emergencies on at that time.
Mr. BARNARD. Mr. Erdreich.
I am trying to get some idea of the reaction that BATF engaged in and not trying to Monday morning quarterback BATF, but I asked a question earlier about the level of risk, the health risk involved.
If I read your testimony on your opening page, you said that FDA provided a health assessment while BATF engaged in a sampling and compliance program.
Then on page 8 you talk about what your assessment is of the health risk of DEG. You say that given the amounts of DEG that have been found, the types of wine involved, et cetera, your estimate of intake necessary to produce harm, you believe it unlikely that an illness has or will occur, and that there has been no report of illness or injury to date.
Looking at chart C, which has been discussed earlier, and noting that less than a gram of DEG in a liter of wine was found in some wines and larger quantities in others—was it your recommendation to BATF that they should recall all wines that had DEG levels? Or that they should just go after those at the high level of contamination or DEG levels?
Mr. TAYLOR. One of the problems with the DEG and what we told BATF is that it is illegal at all levels because it is an unapproved food additive. It is put in there as a sweetening effect. So as far as we are concerned it was illegal in all levels.
As far as you are talking about levels of concern, that is a different story. But it was our position and still is because that is our law, that it is illegal at any level, if we can confirm it is there.
Mr. MRAZEK. Will the gentleman yield?
Mr. MRAZEK. Mr. Taylor, are you in a position to say that if in certain wines you find nine parts per million (ppm) that has repre
ented an intentional utilization of DEG for sweetening purposes at that level?
Mr. TAYLOR. From what we know at the present time and the information we have there is no background level of DEG in wine. Now, we know that there are levels of methanol in wine, but as far as we know, as far as I know, there is no background level of DEG in wine.
Mr. MRAZEK. My point is this, if you have certain wine producers that put 19,000 ppm DEG in the wine for sweetening effect, I have to believe that if you put nine parts in per million it is not going to have an appreciable effect.
Mr. TAYLOR. The point is well taken, but it shouldn't be there. If a manufacturer runs across a situation of this nature where they are saying they have a background of 9 ppm in their product and it is naturally occurring and they wish to come in and prove it to the agency and if they do it successfully, then at 9 ppm it wouldn't be a health hazard, we would consider that.
Mr. MRAZEK. Thank you.
Mr. ERDREICH. I guess what I am trying to get at and I understand you are saying that it is illegal if there is any amount.
Mr. TAYLOR. If you ask me whether all the levels up there are a health hazard, the answer is no.
Mr. ERDREICH. OK. I appreciate your answer.
I am not trying to raise the question from your agency of what you should or should not have done. I guess I am questioning what BATF did and that I am really concerned about advising the public in press releases generally of a supposed health risk when I am hearing that there apparently was not a health risk at some levels here.
It just seems to me we should have better ways to deal with these problems besides a generalized alert that would elevate people's concerns much beyond the true health risk involved.
What you are doing is perfectly correct. I understand as far as your agency is concerned, as far as the law and requirements, and I am just trying to get a sense of what should be done differently so that we don't alarm the consuming public at large where there is not a health risk. I think that does a disservice as much as it does a service to find contaminants in the products and alert the consumers where there is a health risk.
I think what you did, I understand it is a statutory requirement of your agency.
Mr. HORTON. Would you yield?
Mr. HORTON. I think you are making a good point. I think there is an inconsistency and perhaps you can explain it.
As I read the testimony, or as I heard the testimony from Mr. Drake, on page 3, this is the context in which he puts this subject. He said,
We also contacted the Food and Drug Administration, who told us that DEG at high levels posed a more immediate health threat, but that there could be a cumulative effect on the kidney and liver at relatively low levels. The best scientific information available reflects that there is no tolerable level for DEG.
Now, that is different than saying what you said. You said that you have not adopted a policy, so therefore there is no legal basis for it. But they have construed that to say that there is no tolerable level.
And then he goes on:
This led us to what I believe to be the only rational conclusion. This is the conclusion. That the presence of any amount of DEG in wine posed a potential health threat. Every decision and every step taken flowed from our basic priority of protecting the American consumer.
That is said a little bit different than what you just said.
Mr. LAKE. Let me help clarify a point about that because I think that may
be a source of some confusion. When we evaluate a petition, say, for a food additive or when we try to establish an action level, we insist on a great deal of data.
In fact, for food additives, we may require considerable testing so that we can determine not only what the acute effects might be on a one-time or short-term basis but also so that we can evaluate long-term effects for continued use over a long period of time.
I think what we were really saying in the case of DEG is, how much would be an immediate hazard? We initially did a search on experiences reported in the literature, past experiences which related really to primarily acute effects.
There was some information about lower levels being a potential hazard over a long period of time, but the FDA has not received any kind of petition to approve DEG and therefore we have not gone through the data requirements, the exercise we would go through in setting a limit for a food additive, such as we did with aspartame where there were nearly 200 studies that we evaluated not only to determine short-term effects but also to determine lifetime exposure and what that would do.
So what we were saying here is that we are not prepared to say that any particular level of DEG is safe. We have not gone through that process.
We did go through a process of making a judgment about roughly the range, based on information in the literature, that might present first an acute hazard and then maybe a little lower range that might present some effects over a longer period of time.
I don't believe we have nearly the kind of data that we would like to have if we were actually going to approve DEG as a food additive and establish a safe level. For that reason, I would in fact disagree with the GAO suggestion that we set an action level. That would be to condone the deliberate addition of DEG at levels below the action level and we are not prepared to do that.
Mr. HORTON. Just one further question. I think it would be helpful if you could furnish a response for the record. On page 3 of the GAO report, the last paragraph has to do with toxicity and health risk associated with DEG consumption. They go into a whole paragraph about this subject. Could you take a look at that and then give us your thoughts with regard to that particular paragraph? Are they on track or not on track? How does it fit into your thinking and so forth?
I think that would help the committee to resolve this type of problem.
Mr. LAKE. Yes, sir. [The information follows:] The toxicity and health risk associated with relatively short-term exposure to DEG as described on page 8 of our testimony is consistent with the discussion on pages 3 and 4 of the GAO report. (Note: In this context, relatively short-term refers to exposure periods of less than a lifetime. Because the presence of DEG in foods is not unavoidable and it is illegal at any level, lifetime feeding studies in animals have not been conducted for DEG.]
Mr. MRAZEK. If I could intercede with one question, I would appreciate it.
You made a point of stating a couple times "deliberate addition" of DEG. In the GAO analysis, they say “purposely added DEG." I can understand again that certain Austrian wine manufacturers deliberately added DEG to wine as a sweetener. However, I find it hard to believe that trace elements will have an impact; in fact, I am informed that they have no impact on taste at trace levels.
Is it possible, what should the approach be when in fact it was not a deliberately added element?
Mr. LAKE. Well, I think again to get back to what Mr. Taylor was saying, it had to be deliberate at some point. Maybe the wine was blended in such a way as to reduce the ultimate concentration where you blend one with high concentrations, perhaps it was used as a processing aid for some other technical effect, and then only with some residual ending up in the wine. I do not know that.
What I do know is that if it is there and it is not naturally occurring, then some human element was involved, either carelessness or otherwise, in its being there. It is simply not allowed for that purpose or for any purpose in wine.
Mr. MRAZEK. Thank you.
Mr. HORTON. Mr. Chairman, I have some questions, also, that I will submit for the record and I would also make the same statement to you, Mr. Taylor, that I made to Mr. Drake. We are not here trying to hang anybody, hang any agency on the wall like a trophy.
What we are trying to do is make certain that in a positive way we find out how can we solve this problem of making certain that foods, in this case, wine, that is made available to the consuming public is not hazardous to health and that they can use it without any concern or problem.
As a matter of fact, I am sure you are aware of the fact that Dr. Frank Young is a very close personal friend of mine and I personally talked with him. He used to be at the University of Rochester in my district. I knew him before he came down to head up your agency, and I think he is doing an outstanding job, and I know he is very concerned about this whole problem because I have talked with him about it.
One question I wanted to ask was that your testimony on page 4 implies that you evaluated the health risk in choosing your method of testing foods by concentrating on those most likely to contain residues. Don't you think that BATF should have acted similarly in targeting the most highly contaminated wines rather than refusing to establish any priorities in this matter?
Mr. TAYLOR. Based upon what was in the BATF testimony and the impression they got from what we had said regarding health hazards, and we could have done a better job on our original assessment to them, what Mr. Drake assumed we were saying that everything was contaminated to the point at which we required a recall, they acted improperly with the information we had given them.
Mr. HORTON. GAO was somewhat critical of BATF's handling of this matter. Do you disagree with GAO's conclusions in any way?
Mr. TAYLOR. I really cannot say. I really have not looked into everything that happened.
Mr. HORTON. I am just talking about the conclusions.
Mr. TAYLOR. Yes. I think the way the situation was handled between the two agencies, between BATF, and the problem that was involved I think they did an excellent job.
I disagree with GAO, yes.
Mr. HORTON. What about the future? What are you doing now? Have you transferred your authority? Do you have an agreement with BATF now that they will monitor for contaminants in wine?
Mr. TAYLOR. No. We are studying the problem, as Mr. Drake said. We have had one meeting. I wouldn't want to see anything very rigid. In some instances, it might be a problem where we have the analytical capability and BATF does not. I think we should try to merge the two systems so we can get the best consumer protection possible. That is what we are working for in our deliberation.
Mr. HORTON. What authority do you have and what efforts do you take now to scrutinize and regulate and oversee the American wine industry and wine grape growers?
Mr. TAYLOR. We do have inspections. We have contracts with four States to go in and do the inspections for us in wineries: New York, California, Oregon, and Ohio. We occasionally go in and do analyze wine samples for pesticides and for filth, et cetera.
Mr. HORTON. Thank you very much, Mr. Chairman. I will submit the other questions in writing.
Mr. Horton's questions and the agency's responses follow:)