PROCEDURES FOR IMPORTING ITALIAN WINES
Importers, Wholesalers, and Others Concerned:
PURPOSE. The purpose of this circular is to inform permittees of procedures for importing Italian wines produced in the Veneto region of Northern Italy. Separate guidance will be provided by ATF to importers for Italian wines already in the United States which have been identified as containing methyl isothiocyanate.
BACKGROUND. In January 1992, the Bureau of Alcohol, Tobacco and Firearms (ATF) received information that some Italian wines produced in the Veneto region of Italy had been found to contain the pesticide methyl isothiocyanate (MITC) which had been added to the wine during its production and storage. The Food and Drug Administration (FDA) has advised ATF that the direct addition of MITC to wine is a food additive use. Since no food additive regulation permits MITC to be used in wine, the FDA has further advised that such a practice is prohibited, and any wine containing added MITC (at a
level of analytical ability to quantify and confirm) is adulterated pursuant to sections 402(a)(2)(C) and 409 of the Food, Drug and Cosmetic Act, 21 U.S.C. §§ 342(a)(2)(C) and 348. FDA stated that to establish this type of adulteration and to undertake a regulatory sanction, it is not necessary to demonstrate that the presence of MITC is harmful; rather, the Government must only demonstrate that MITC is not sanctioned by law as a food additive. The ATF National Laboratory and FDA have determined that the analytical ability to quantify and confirm level (that is, the minimum detection level) is 0.02 parts per million (ppm).
Wines containing MITC do not conform to the standard of identity for wine. A wine which has received an approved certificate of label approval (COLA) but which is subsequently found to contain MITC is no longer considered covered by an approved COLA because the product is, in fact, different from the product which was approved. ATF could not approve a COLA for a wine containing MITC at a level of analytical ability to quantify and confirm because the wine is deemed an adulterated product under the Federal food and drug laws. Additionally, grape wine containing MITC does not conform to the standard of identity for grape wine as prescribed in 27 CFR § 4.21(a) and is not eligible for a COLA covering a grape wine.
In view of the above, and because under 27 U.S.C. § 205(e), no wine can be released from customs custody for consumption in the United States without an approved COLA, any wine found in customs custody to contain MITC (at a minimum detection level of 0.02 ppm) will not be released from customs custody for consumption in the United States.
ATF began extensive testing of all Italian wines, focusing primarily on those wines originating from the Veneto region. Results of the tests conducted by the ATF National Laboratory disclosed the presence of MITC in a small percentage of imported wines from the Veneto region. As a result, ATF requested a health hazard evaluation from the FDA on MITC and, as noted, was advised that the wines containing MITC at a level of analytical ability to quantify and confirm (that is, 0.02 ppm) are adulterated. While FDA also stated it would have a heightened health concern about wines with levels of MITC above 2 ppm, no wines at this level have been found at this time.
ACTION. Based on the results of these tests, and in cooperation with the FDA and the Customs Service, the following procedures are being initiated.
1. Wine shipments established as containing MITC (at a detection level of 0.02 ppm or more) will not be released from customs custody for consumption in the United States or permitted entry into United States commerce.
2. The Italian Government has instituted an MITC testing procedure for wines exported to the United States from the Veneto region. These shipments will be accompanied by a certificate of analysis prepared by an Italian laboratory using ATF testing protocol and approved by the Italian Government declaring that the wine in the shipment does not contain MITC (At a minimum detection level of 0.02 ppm). Wines from the Veneto region of Northern Italy may be released from customs custody upon presentation of either (1) a certificate from an Italian laboratory as described in the preceding sentence or (2) a statement by the importer that such wines do not contain MITC (at a minimum detection level of 0.02 ppm). Such statement by the importer must be supported by an appropriate laboratory analysis report concerning MITC according to ATF testing protocol. This laboratory analysis report procured by the importer may be obtained either before or after the product is released from customs custody. The alternate procedure available to the importer is primarily intended to cover shipments of wine in-transit to the United States prior to implementation of the certification procedure by the Italian Government. A copy of either the (1) Italian laboratory certificate or (2) laboratory report obtained by the importer should be retained as a record at the importer's premises. A copy of either report should be sent to ATF'S Special Programs Branch, Compliance Operations, P. 0. Box 50221, Washington, DC 20091- 0221. ATF testing protocol is also available upon request from the Special Programs Branch.
Permittees are cautioned that the marketing of an adulterated and mislabeled wine under the interstate and foreign commerce jurisdiction of the Federal Alcohol Administration Act is unlawful. Permittees are advised that ATF will consider it a willful violation of such Act and grounds for suspension or revocation of a basic permit where ATF finds wine from the Veneto region in the United States market
containing MITC (at a minimum detection level of 0.02 ppm) for which the permittee does not possess sufficient evidence to establish that the product does not contain MITC at a detection level of 0.02ppm or more.
3. ATF will continue testing Italian wines originating from the Veneto region on a random basis. Should subsequent testing by ATF indicate the presence of MITC (at a minimum detection level of 0.02 ppm), ATF will take enforcement action against such wines based on its analysis regardless of any commercial laboratory analysis report for the wine in question.
This certification will be required until such time as ATF deems that wines produced in the Veneto region no longer are adulterated with MITC.
INQUIRIES. Inquiries concerning this circular should refer to its number and be addressed to: Bureau of Alcohol, Tobacco and Firearms, 650 Massachusetts Avenue, NW, Washington, DC 20226, Attention: Office of Public Affairs or call (202) 927-8500.
Stephen E. Higgins