Unauthorized Pesticide Verification and Enforcement Program for Wine
To: Wine Producers, Rectifiers, Blenders, Importers and Wholesalers, and Others Concerned.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) routinely conducts pesticide analyses of domestic and imported wines. This circular outlines TTB’s policy regarding wines found to contain unauthorized pesticides or quantities of pesticides in excess of authorized levels under the Federal Food, Drug and Cosmetic Act (FD&C Act, 21 U.S.C. 346a) and its regulations for grapes and wines. If unauthorized pesticides or quantities of pesticides in excess of authorized levels are found in wines, TTB will consider that such wine is not covered by an approved certificate of label approval (COLA) and that the label is misleading and, therefore, in violation of the Federal Alcohol Administration Act (FAA Act, 27 U.S.C. 205(e)). TTB will take appropriate enforcement action in such a case.
Section 408 of the FD&C Act (21 U.S.C. 346a) authorizes the Environmental Protection Agency (EPA) to set maximum residue levels, or tolerances, for pesticides used in or on foods. A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. In general, without an applicable tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under sections 402(a)(2)(B) and 408(a) of the FD&C Act (21 U.S.C. 342(a)(2)(B) and 346a(a)).
Accordingly, any wine containing unauthorized pesticides or quantities of pesticides in excess of authorized levels is adulterated under the FD&C Act. What constitutes an “authorized level” in some cases may involve a variety of factors based on the FD&C Act and may not simply be the level established by a tolerance or the lack of one. Therefore, consultation with the Food and Drug Administration (FDA) and, if necessary, EPA to establish whether a product is adulterated under the FD&C Act by virtue of the presence of a pesticide is of paramount importance before TTB takes enforcement action under provisions of law it administers. For example, in a recent case involving the pesticide oxadixyl, TTB identified the pesticide in various wines and consulted with and received verification from FDA and EPA that wine containing any amount of oxadixyl is adulterated. For other pesticides, TTB will follow the same process of consultation with FDA and, if necessary, EPA for a determination that a wine is adulterated before it takes enforcement action. However, to take regulatory action on the basis of a finding under the FD&C Act that a product is adulterated because of the presence of a pesticide, it is not necessary for TTB to ask FDA to conduct a health hazard evaluation or to demonstrate that levels of a pesticide in excess of authorized levels are harmful; rather, the Government must only demonstrate that the pesticide is unauthorized or of a quantity in excess of authorized levels.
Under the FD&C Act, FDA has authority to take enforcement action with respect to adulterated food products, including alcohol beverages, both domestic and imported. FDA and TTB have entered into a memorandum of understanding (MOU, 52 FR 45502, Nov. 30, 1987), in which they have delineated their enforcement responsibilities and provided for collaborative efforts. Pursuant to this MOU, TTB has primary responsibility for issuing recall notices and monitoring voluntary recalls of alcoholic beverages that are found to be adulterated under the FD&C Act or mislabeled under the FAA Act by reason of being adulterated. The MOU also provides that this agreement does not affect or otherwise attempt to restrict the seizure or other statutory and regulatory authorities of the respective agencies.
A wine which has received an approved COLA but which is subsequently found to contain an unauthorized pesticide or a quantity of a pesticide in excess of authorized levels is no longer considered covered by an approved COLA because the product is, in fact, different from the product identified on the approved label. TTB will not approve a COLA for a wine containing an unauthorized pesticide or a quantity of a pesticide in excess of authorized levels because the wine is deemed an adulterated product under the FD&C Act. Additionally, grape wine containing an unauthorized pesticide or a quantity of a pesticide in excess of authorized levels does not conform to the standard of identity for grape wine as prescribed by regulations issued under the FAA Act at 27 CFR 4.21(a) and is not eligible for a COLA covering grape wine.
If it is determined that an unauthorized pesticide or a quantity of a pesticide in excess of authorized levels is present in a finished wine, TTB will advise the responsible industry member as to this determination and as to TTB’s response. Additionally, TTB expects the industry member to take an appropriate course of action, which might include a voluntary recall. TTB will consult as needed with FDA and EPA and, in situations involving a recall of an adulterated wine, keep FDA apprised of developments with respect to such recall.
With regard to imported products, TTB regulations provide that no imported beverage wine in containers shall be released from customs custody for consumption unless there is deposited with the appropriate customs officer at the port of entry the original or a photo static copy of an approved COLA. See 27 CFR 4.40; see also 27 U.S.C. 205(e). While an importer may have valid COLAs for wines that do not contain unauthorized pesticides or quantities of pesticides in excess of authorized levels, these COLAs would not cover wines containing such pesticides. Therefore, no such wine may be released from customs custody. A similar situation would arise where a domestic bottler bottles wine containing an unauthorized pesticide or a quantity of a pesticide in excess of authorized levels.
Such wine would be considered as being bottled without an approved COLA. In addition, under the FAA Act, mislabeled wine, including the adulterated wine described, may not be sold or shipped, delivered for sale or shipment, or otherwise introduced or received in interstate or foreign commerce by an importer or wholesaler. See 27 U.S.C. 205(e); 27 CFR 4.30 and 4.39.
TTB’S POLICY REGARDING UNAUTHORIZED PESTICIDES FOUND IN WINE
- Identification of Adulterated Wine
- TTB may identify wines that have unauthorized pesticides or quantities of pesticides in excess of authorized levels through a variety of programs and sources, including the following:
- Products tested as part of TTB’s Alcohol Beverage Sampling Program that focuses on imported and domestic wine specifically every three years. The program entails purchasing samples in the marketplace using random sampling to produce accurate estimates of compliance across the industry in terms of their being correctly labeled, free of tested contaminants, and conforming to standards of identity requirements. Noncompliant wines are brought into compliance;
- Information we receive from competitors or consumers about unauthorized pesticides or quantities of pesticides in excess of authorized levels in wines;
- Information from news/internet sources concerning pesticide issues in wines from a particular country;
- Products tested as part of TTB’s Import Safety Program which focuses on imported wine on an annual basis. Wines are purchased in the marketplace using random sampling to produce accurate estimates of compliance of imported wine in terms of their being correctly labeled, free of residues of unauthorized pesticides or quantities of pesticides in excess of authorized levels, and free of other tested contaminants. Noncompliant wines are brought into compliance;
- Wines from a particular country that were tested based on TTB’s risk analysis (e.g., due to the frequent occurrence of unauthorized pesticides or quantities of pesticides in excess of authorized levels in that country’s wines);
- Products submitted to TTB’s laboratory for analysis under some other program;
- As provided for under the MOU, when FDA learns or is advised that an alcoholic beverages is or may be adulterated, FDA will contact TTB.
- TTB’s laboratory is authorized to analyze the samples of each wine obtained using random sampling to determine the presence of unauthorized pesticides or quantities of pesticides in excess of authorized levels.
- TTB will consult with FDA and, if necessary, EPA to determine whether the pesticide found is unauthorized or is present in excess of authorized levels, and is therefore adulterated under the FD&C Act. As indicated above, TTB has already done so with respect to oxadixyl.
- Determination of the Scope of Adulteration
When unauthorized pesticides or quantities of pesticides in excess of authorized levels are found in wine, which is therefore adulterated, as described above, TTB may request, per 27 CFR 4.38(h), that the wineries or importers provide documentation on how much of the adulterated wine was produced/imported and/or demonstrate that their other wines (e.g., same brand name but with another vintage) do not contain an unauthorized pesticide or a quantity of a pesticide in excess of authorized levels by sending us the results of laboratory analyses of the identified wines. Section 4.38(h) provides that TTB may request an importer or bottler, among others subject to this provision, to provide a full and accurate statement of the contents of the labeled wine. In the case of imported wine, TTB may also request information from the foreign producer. TTB will determine the scope of the potential distribution in the U.S. marketplace.
Specifically, among the items of information we may request from domestic and foreign producers and importers are:
- The brand name(s) of the wine(s);
- The name of the producer;
- The name of the bottler;
- The vintage date(s) of the wine tested;
- The name of the entity that shipped the wine;
- The name of the U.S. importer receiving the wine;
- The TTB ID Number on the COLA;
- The date(s) of all shipments (past and future);
- The expected arrival date(s) of future shipments; and
- Results of laboratory tests which show that the specific wine(s) tested are free from unauthorized pesticides or quantities of pesticides in excess of authorized levels.
This information may be sent to TTB via fax using (202) 453-2873 or via email using email@example.com. TTB reserves the right to analyze the wines in question in its laboratory to confirm the analytical results submitted by the wineries. TTB’s analytical method for pesticide analysis in wine.
- TTB Enforcement and Notification
- All future shipments of imported wine that TTB has a reasonable basis in fact to believe is adulterated due to the presence of an unauthorized pesticide or a quantity of a pesticide in excess of authorized levels may be the subject of a request to U.S. Customs and Border Protection (CBP) for the denial of release from customs custody into the U.S. marketplace until we confirm that the wines are not adulterated. Under 27 U.S.C. 205(e), CBP officials are authorized to deny release of bottled wine not covered by an approved COLA. (If adulterated wine is imported in bulk for bottling by a domestic winery, the winery would not be able to obtain an approved COLA for the bottling of such wine containing an unauthorized pesticide or a quantity of a pesticide in excess of authorized levels.)
- TTB may request that CBP temporarily refuse entry of the identified wines.
- TTB may request that the U.S. importer voluntarily detain any container that might be removed in violation of law.
- Upon receipt and examination of the laboratory analyses, either from the producer or the U.S. importer, or based on the findings of the TTB laboratory analysis, TTB will act accordingly:
- If the results indicate that the wines are not adulterated:
TTB will contact CBP and affected importers to confirm that the wines are unadulterated and may once again be allowed entry into the United States. With respect to domestic products, TTB will notify domestic producers and others notified of the initial adulteration finding to inform them of the results showing that the product is not adulterated.
- If the analyses confirm that the wine is adulterated:
- TTB will contact the importers in any case in which it has made a request to CBP for the denial of release from CBP custody, and those shipments may not enter the United States. In the case of domestic products, it will also notify domestic producers and others to inform them of the consequences of the finding of adulteration.
- TTB may, after consultation with FDA, request that industry members voluntarily recall products that are found to be adulterated.
- TTB will strongly encourage the recalling firm to issue publicity regarding the recall.
- TTB may pursue action to suspend or to revoke the FAA Act Basic Permit of industry members who willfully violate the conditions of their permit with respect to mislabeled, adulterated products. See 27 U.S.C. 204. TTB also may seek an offer in compromise covering the liability arising with respect to violations in the sum of not more than $500 for each offense (e.g., for each bottle of wine that has been willfully imported into the U.S.), an injunction, or criminal prosecution. See 27 U.S.C. 207.
- TTB will consult with FDA prior to issuing a press release on adulterated products. TTB may also issue notices and warnings to the general public and trade associations for the purpose of alerting specific populations about wines that contain unauthorized pesticides or quantities of pesticides in excess of authorized levels.
- Pursuant to TTB regulations at 27 CFR 4.38(h), unless TTB determines that the product is not adulterated, TTB may require the U.S. permittee to send to TTB reports on chemical analyses for up to one year from the date of TTB’s letters to them notifying them of the adulteration. At that point, TTB will reevaluate the need for this enforcement mechanism. TTB may also analyze any product, regardless of any other laboratory analytical results.
- More severe sanctions may be considered in any case where an industry member might choose not to voluntarily detain or recall an adulterated wine.
If you have any questions about this Industry Circular, please contact the Market Compliance Office by one of the following methods:
Mail: Alcohol and Tobacco Tax and Trade Bureau
Advertising, Labeling and Formulations Division – MCO
1310 G Street, NW., 4th Floor West
Washington, DC 20220
Phone: 202–453–2250 or 866–927–2533 (toll free), and press “5”
John J. Manfreda
Alcohol and Tobacco Tax and Trade Bureau