-2 Minimum toxic effect (increased oxalate excretion) may be seen at 6 pm DEG/day (about 5.5 ml). Oxylate crystals in körey may be seen at about 12 gm DEG/day (about 11 ml). Calvary and Klumpp stated (1939) that man may be more susceptible than other species, which may make above levels of DEG even more toxic to humans. Their opinion was based on 25 ml of DEG being fatal in some people and on the pathological findings from the 1938 sulfanilamide elixir episode. Diethylene Glycol is not allowed as a direct food additive in 21 CFR Food Additive Regulations. It may occur as a contaminant limited to low levels in some ethylene oxide condensates (e.g. polyethylene glycol) used as food additives. However, any purposefully added DEG to food is not authorized by the regulations and any such imported food would be considered illegal. Charles J. Kokoski, HFF-156 Mr. HORTON. One further question. Mr. Wessinger, in your opinion what is the best way to assure that contaminated wines that represent a public health hazard are identified and removed from the market? Mr. WESSINGER. I don't know that I have a solution to that, Mr. Horton. Mr. HORTON. Leave it up to the agency to determine that? Mr. WESSINGER. That is a good question. I think it is one we all have a justifiable need to be concerned about. Short of 100 percent testing, I just don't know how you can have that degree of assur ance. Mr. HORTON. If you know something is a health hazard, if you have a suspicion, there ought to be some recall procedures, should there not be? Mr. WESSINGER. There should be a recall procedure or adequate followup in such a way you know all that material has been removed from the market. Mr. HORTON. Thank you, Mr. Chairman. Mr. BARNARD. Mr. Mrazek. Mr. MRAZEK. Thank you, Mr. Chairman. I am a little confused as to who we ought to be relying on for certain types of tests, which can confirm the wholesomeness of the products we would be consuming in this country. I am curious in particular about how it would be possible that the July 12, 1985, document, which determines minimal levels for potential risk to health, would not be utilized in trying to make a determination on which products represent a danger to public health. We know that that memo was sent. You confirm it, in fact, was received. Yet, that following December a lot of attention was paid to urging the recall of wines which had 6 to 10 parts per million, approximately, of contamination with DEG while other products with 19,000 parts per million were not addressed with the same kind of diligence. I am curious to know why you think that was, in fact, the case? Mr. DOMENICK. It seems to me that by taking the position that any amount whatsoever causes this to be adulterated and requiring it to be taken off the market, BATF was put in the situation of dealing with an awful lot of wines and an awful lot of work to assure that all the right actions were taken. If there was an amount that could be identified as a trigger amount, that says below this amount we can live with the risk; above that amount, we cannot. It would have allowed the focusing of the effort on those wines that presented the greatest risk. Mr. MRAZEK. We have seen some preliminary studies that suggest you can, in fact, quantify at least to a certain extent the potential risk; and I would assume, therefore, you are suggesting that one positive direction we might pursue in the way of new regulations is to set some type of gradient for contamination by this DEG problem or other contaminants. Mr. DOMENICK. Yes. Deciding on the number involves an awful lot of judgment and educated guesswork. There is no scientific proof that says this is the number, beyond the shadow of a doubt. There are certain scientific judgments that have to be made. I would liken it to the situation with FDA and food and the setting of action levels for pesticides. A decision is made that says so much of it we can live with; beyond that amount, we need to act and remove from the market. It seems to me the wine situation is very similar to that. Whatever the contaminant might be, a decision needs to be made how much of it represented a risk that we can live with and at what level does it pose a risk that we need to act to ensure that is taken off the market. Mr. MRAZEK. To what extent were some of these problems caused by a lack of staff or resources on the part of the BATF? Mr. DOMENICK. I am sure resources were a factor in all of this. I think perhaps that-in hindsight Mr. MRAZEK. There has been certain criticism of the lack of a master list being presented to the regional agencies, those kinds of things. Does that stem, in your view, from a combination of problems including lack of adequate staff, or is it a management problem? Mr. DOMENICK. I think there are things that could have been done in a way that would have reduced the burden that resources would play in this whole thing. If one had proceeded a little differently, the level of resources necessary to follow up and assure certain things happen could have been better targeted, and thus the resource problem could have been minimized. By approaching everything as a problem, it requires many more resources to follow up and make assurances that certain testing got done, that certain wines were taken from the market. Mr. MRAZEK. Have you been in a position to look at the whole question of unauthorized ingredients in both domestic and foreign wines? Or have you only looked specifically to these? Mr. DOMENICK. We were specifically asked to address the question of the DEG-contamination issue. That was primarily our focus there. We are doing a larger job for Congressman Horton where we are looking at FDA's monitoring of imported food for pesticide residues. Mr. MRAZEK. I wonder if that could conceivably be expanded? I know I read a recent Wall Street Journal article which suggested there are certain domestic wines where fish glue is utilized as a clearing agent and other wineries utilize hydrogen peroxide to bleach red grapes to make white wine. I personally don't know if it represents a serious problem or not. You know, in the final analysis, I guess I have no discrimination against domestic or foreign wine. I enjoy a variety of both domestic and foreign-produced wines. I haven't noticed any significant health problems internally up to this point, but perhaps it would be worthwhile to take a good look at the whole range of unauthorized ingredients in wines and come up with some general standards. Mr. HORTON. Would the gentleman yield on that? We have witnesses that are going to testify later. They will testify, I think, to requirements and restrictions we have with regard to American wine. I think that is important in this hearing to establish the standards that the local-the American industry is held to and the type of things you are talking about, they would not be permitted to put those wines on the market. Mr. MRAZEK. Well, I am sure the Wall Street Journal has some thing to learn, as well as the rest of us up here on the panel. Thank you very much, Mr. Chairman. [The Wall Street Journal article referred to follows:] Wall Street Journal, April 16, 1986, page 35 What's in Wine? More Than You Might Imagine By TRISH HALL Staff Reporter of THE WAll Street Journal Although the Italian wine makers who added toxic substances to their product were, at the least, reckless, in one sense they weren't doing anything unusual. Wine makers the world over put many additives into their products. The U.S. government, for example, allows wine makers to use about 80 additives that are considered safe for the population at large. Many of these don't show up in the final product, but some remain, and some of these may provoke reactions in allergic people. For years. the Center for Science in the Public Interest has been pressing the gov ernment to require that ingredients remaining in the beverage be listed on the labels. A court decision could settle the issue by fall. The wine industry has opposed that rule but now appears ready to accept a newly proposed regulation calling for labeling of wines containing sulfites. U.S. wine makers can legally use chemicals that help in fermenting and clarifying wine and in stabilizing its color and taste. Some of the most commonly used additives are sulfiting agents and sorbates, which are preservatives, and egg whites or fish glue, which clear the wine. Many People Affected "All of these have been shown to cause allergic reactions,' says Bruce Silverglade, legal director at the Center for Science. He cites a 1980 government estimate that up to 1.7 million people are allergic to some of the ingredients used to make alcoholic beverages. The Wine Institute, a trade group, argues that a general labeling requirement would cost the U.S. industry $45 million a year and that there isn't a health hazard. John DeLuca, its president, says filtering agents such as egg whites appear in finished wine in only minute amounts. These don't threaten allergic people. he says: "At worst you would get discomfort." He adds, though, that sulfites could be an exception. The industry will probably support sulfite-labeling regulations, he says, because its own research shows that as many as 5.000 asthmatics may be sensitive to the chemical. In addition to the additives that concern Mr. Silverglade, many others are used in wine making. Gum arabic, common as a food additive, is used as a stabilizer. Wine makers also use citric acid, tartaric acid or malic acid to remedy imbalances and improve taste. Sugar is permitted as an additive in Europe, but not in California. which produces most U.S. wine. Oak Flavor Some wineries try to keep prices low by adding a chemical to impart an oak flavor instead of aging the wine in costly oak barrels. Some additives are used for ease of processing: some wineries, for instance, use defoaming agents such as silicon dioxide to prevent vats from overflowing when grapes are crushed. In addition, Mr. Silverglade says, some wineries use hydrogen peroxide to bleach red grapes so they can use them to make white wine. Although there's no health hazard, he says it's a "rip-off" of consumers and he believes they ought to know such processes are used. "The industry fears the marketplace reaction when consumers find out certain brands have additives and certain other brands are natural." he adds. The fight over labeling has been going on for years. The Carter administration proposed a rule requiring labeling, but the Reagan administration rescinded it before it took effect. Last fall, a federal court ruled that the Treasury Department, whose Bureau of Alcohol, Tobacco and Firearms regulates the industry, couldn't rescind the rule. The Treasury Department is appealing that decision to the U.S. Appeals Court in Washington, which is expected to hear arguments May 23 and to rule by the end of summer. If it upholds the decision, consumers may see ingredient labels on alcoholic beverages next year. The requirements are weak compared with standards imposed on the food industry. Wineries could either list the primary ingredients or provide an address where consumers could obtain a list in 30 days. Paul Draper, wine maker and partner at Ridge Vineyards. Cupertino, Calif.. fears that the requirement would give imported wines an advantage because the U.S. government couldn't check the accuracy of foreign labels. "American industry will be at a further disadvantage and the consumer will learn nothing from their labels," he says. But not all wine makers oppose labeling. Walter S. Taylor, owner of Bully Hill Vineyards in Hammondsport. N.Y., discloses ingredients on his labels and believes all vintners should. "Any winery in the world can add all this stuff to it and call it pure and natural. It's a complete deception." he says. |