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chemicals that could possibly be added to food through unscrupulous practices; and, therefore, FDA would not normally monitor for residues of DEG unless there was reason to suspect that the substance might be present.
Although FDA's import testing does not focus on the detection of unapproved food additives, FDA can effectively compel a wine importer to test for such an adulterant through its authority to refuse entry where it has sufficient reason to believe that the wine may be adulterated. The importer has the right to present evidence in such situations to show that a particular shipment is in fact not adulterated. This evidence may be in the form of results of actual testing done by a private laboratory.
FDA could have used this authority in the 1985 situation involving DEG and refused entry to those brands of Austrian wines that FDA had reason to suspect were contaminated. The agency could not have reasonably justified automatic across-the-board detention of all Austrian wines until sufficient evidence was accumulated to indicate a generic Austrian wine problem, especially since the Austrian Government had originally advised us that no wines containing DEG had been exported to the United States.
For imported wines already in commerce in the United States, FDA does not have the authority to stop shipment based on the suspicion of adulteration. Neither does FDA have the authority to require a distributor or retailer to test or analyze wine for a given contaminant. As I previously indicated, FDA could conduct its own testing of samples obtained from the wholesalers and distributors, but such an all-out effort would be extremely resource-intensive and is usually based on a serious public health concern. If FDA had proof that wines in interstate commerce contained an unapproved food additive or were otherwise adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act, FDA could request but not order their removal from commerce. If the wines were not removed, FDA could commence litigation in cooperation with the Department of Justice on a lot-by-lot basis. This type of litigation can be time-consuming and is also only carried out where we have investigational and analytical evidence demonstrating that the specific bottles of wine to be seized actually contain DEG.
BATF and FDA both possess the analytical capability to test wine samples for a number of contaminants; however, FDA has greater experience in analyzing foods for a wide array of diverse chemical contaminants at very low detection levels; that is, parts per billion. Of the two agencies, only FDA has the expertise to assess the toxicological implications of an impurity or the risk it presents to the public health.
The working relationship between the two agencies involves a division of labor that takes these analytical capabilities into account, as well as the differences in the enforcement mechanisms available to each agency. Thus, in situations such as that involving DEG, the nature of the Federal response is dictated by the following kinds of questions:
(a) What is the legal status of the contaminant?
(b) What analytical and toxicological determinations are needed? (c) What is the most efficient and effective enforcement strategy for the particular problem?
As I stated previously, FDA considers DEG to be an unapproved food additive that was deliberately added to Austrian wines as well as to some Italian and German wines for its sweetening effect. Thus, all wines containing DEG could be removed from domestic commerce regardless of the levels of DEG present or the potential health hazards associated with those levels. The issue for Federal authorities, therefore, was primarily how this removal could be most efficiently accomplished.
BATF, in consultation with FDA, agreed to assume this responsibility because it possesses the analytical capability to test wines for DEG and it has greater leverage to compel compliance through its licensure authority over wholesalers and distributors. FDA has the toxicological expertise and addressed the health issue in order to determine the seriousness of the problem.
The recent discovery of high methanol levels in Italian wines is being handled similarly by the two agencies, although the situation is slightly more complicated because methanol does appear naturally in wine. Methanol that occurs naturally is permissible as long as it is not injurious to health. FDA has recently advised BATF that levels of methanol in wine exceeding the natural background level of 0.1 percent by volume would pose a threat to the health of
In conclusion, although several occurrences of alcoholic beverage contamination have been discovered in the past several years, we are satisfied that in each situation the Federal response has been quick and adequate for the protection of the public health. We have also found that the relationship between FDA and BATF has worked well and without any confusion. Given the close working relationship between the two agencies, the need for a written agreement between FDA and BATF has not been felt. However, the two agencies are currently exploring the merits of developing a formal agreement to address the division of responsibilities whenever joint jurisdiction is involved.
This concludes my formal testimony and I will be pleased to answer any questions.
Mr. BARNARD. Thank you very much, Mr. Taylor. [The prepared statement of Mr. Taylor follows:]
I am here today to discuss with you the role of the Food and Drug Administration (FDA) in the regulation of imported wines. Any discussion of our role necessarily focuses on how we work with the Bureau of Alcohol, Tobacco and Firearms (BATF) in the Department of Treasury, the Federal Agency with whom we share jurisdiction in this
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. The adequacy of the Federal response to the discovery of DEG in wines imported from Austria and, to a lesser extent West Germany and Italy, has been the subject of a report by the General Accounting Office issued in March 1986 that provides much of the impetus for this hearing. 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 unless the additive has a status known as GRAS--generally recognized as safe. Since DEG is not GRAS in this country, the FDC Act could be relied upon to prohibit the introduction into interstate commerce of any wine containing DEG in any quantity.
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 be exercised as efficiently as BATF's authority under the Federal Alcohol Administration Act. That Act provides that Agency with authority to take action against wines containing DEG or any other food additives not approved by FDA on the grounds that such wines are improperly labeled and to compel compliance through its licensing authority.