3 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 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 program, its rationale, and the extent to which wines fit into this program. FDA's Import Monitoring The variety and volume of both 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, toxic metals and mold-produced toxins. On an annual basis, FDA samples and tests approximately 5,000 shipments of imported commodities and processed foods which are - 4 collected at ports of entry and analyzed at the Agency's district laboratories. Under the surveillance phase of the program, each FDA field office has primary responsibility for selecting appropriate commodities for random sampling. However, as a general rule in both its domestic and import programs, FDA tests more raw agricultural commodities (e.g., grapes) than processed foods (e.g., wines), because pesticides and other chemical residues tend to degrade, become diluted, or are removed during processing of food. Therefore, in order to utilize its resources most effectively, the Agency has chosen to gear its sampling to those foods which are more likely to contain chemical contaminants. If residues are found in the raw commodity that would be indicative of a possible problem in a processed food, the Agency would intensify its sampling of both the raw and processed food. Prior to the discovery of DEG in imported wines in 1985, however, FDA sampling and analyses of grapes and wine during fiscal years 1982-1985 did not indicate a need to step up our monitoring of these foods. Out of 974 samples of grapes tested (672 imported, 302 domestic) only 5 contained violative pesticide residues. FDA found no violative residues in any of the 53 shipments of wines (20 imported, 33 domestic) that the Agency sampled and analyzed during fiscal years 1982-85. It should also be emphasized that although FDA employs multires idue methods to analyze foods for a number of contaminants at one time, FDA cannot examine all foods for all conceivable contaminants. Thus, not only does FDA concentrate its resources on those foods most likely to contain contaminants, but the Agency also looks for those contaminants most likely to be present in food. - 5 From 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. a practical standpoint, it would be impossible to test for all 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. - 6 Wines Already in Commerce 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 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 FDC Act, FDA could request but not order their removal from commerce. If the wines were not removed, FDA could commence in rem 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. By contrast, BATF possesses the capability to request all wholesalers and distributors of imported wines to conduct tests; those that fail to do so face a prompt loss of their license to distribute alcoholic beverages if BATF's followup sampling efforts reveal the presence of contaminated wine in their inventories. Factors Governing FDA/BATF Relationship BATF and FDA both possess the analytical capability to test wine samples for a number of contaminants; however, FDA has greater - 7 experience in analyzing foods for a wide array of diverse chemical contaminants at very low detection levels (i.e, 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 (e.g., unapproved food additive, unavoidable contaminant, etc.)? (b) What analytical and toxicological determinations are needed? Diethylene Glycol (DEG) 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 |