TTB Interim Rule on Standards for Voluntary Disclosure of Major Food Allergens in Alcohol Beverages
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has issued an interim rule, effective July 26, 2006, which amends 27 CFR Parts 4, 5, and 7 in order to set forth standards that producers, bottlers, and importers of wines, distilled spirits, and malt beverages must follow should they wish to voluntarily declare the presence of certain major food allergens in their products.
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TTB explains that this interim rule parallels the recent amendments to the Federal Food, Drug and Cosmetic Act contained in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), and affects alcohol beverages subject to the labeling requirements of the Federal Alcohol Administration Act. (See ITT's Online Archives or 01/18/06 news, 06011820, for BP summary of the FALCPA, which went into effect for food products on January 1, 2006.)
Highlights of TTB's Standards for Voluntary Labeling of Major Food Allergens
The following are highlights of TTB's standards that producers, bottlers, and importers must follow if they elect to voluntarily declare the presence of major food allergens in wines, distilled spirits and malt beverages (partial list):
Definition of 'major food allergen.' TTB's interim rule states that major food allergen means any of the following: milk, egg, fish (for example, bass, flounder, or cod), Crustacean shellfish (for example, crab, lobster, or shrimp), tree nuts (for example, almonds, pecans, or walnuts), wheat, peanuts, and soybeans, or a food ingredient that contains protein derived from one of the above-listed foods with the exception of any highly refined oil derived from an above-listed food and any ingredient derived from such highly refined oil. This definition provides for the exemption of certain ingredients which have been granted an exemption through a petition process (see below).
Standards contained in interim rule are mandatory if beverages are labeled for major food allergens. While TTB states that labeling for major food allergens is voluntary under the interim rule, the standards contained in the interim rule are mandatory for how industry members must undertake such labeling, should they choose to do so.
If any one major food allergen is declared, all major food allergens must be listed (unless exempted). TTB explains that while major food allergens used in the production of a wine, distilled spirits, or malt beverage may, on a voluntary basis, be declared on any label affixed to the container, if any one major food allergen is declared, all major food allergens used in production of the beverage, including major food allergens used as fining or processing agents, must be declared, except when covered by a petition for exemption approved by the appropriate TTB officer (see below).
Manner in which major food allergens must be declared. TTB states that the major food allergens declaration must consist of the word "Contains" followed by a colon and the name of the food source from which each major food allergen is derived (for example, "Contains: egg").
Interim rule does not require finfish to be labeled at species level. According to TTB, FALCPA provides that in the case of tree nuts, Crustacean shellfish, and finfish the label must list the name of the specific type of nut (e.g. walnut, almond), the species of shellfish (e.g., crab, shrimp) or the species of finfish (e.g., bass, flounder).
TTB states that the interim rule is consistent with FALCPA with respect to labeling of tree nuts and Crustacean shellfish; however, the interim rule does not require labeling of the specific finfish species when an industry member chooses to provide major food allergen information. Instead, the regulations require simply listing "fish" when any type of finfish protein is used in the production of an alcohol beverage. TTB explains that isinglass and fish gelatin are often used to clarify wines and beers and vintners and brewers often do not know, and have no way of easily finding out, which particular species of finfish is used to make the product.
Processing and fining agents must be declared. The TTB states that if alcohol beverage industry members choose to make major food declarations, the interim regulations treat major food allergens used as fining or processing agents in the same way as any other major food allergen used in the production of the alcohol beverage.
Interim rule does not set threshold levels for major food allergens. According to TTB, FALCPA requires allergen labeling for foods regulated by FDA without establishment of any threshold levels for labeling. As such, TTB is not setting thresholds in this interim regulation. TTB states that this position will ensure that consumer have adequate information about the potential presence of even trace amounts of major food allergens in alcohol beverage products.
Petition for exemption from these standards. The interim rule states that any person may petition the appropriate TTB officer to exempt a particular product or class of products that bear voluntary allergen statements from the labeling requirements contained in 27 CFR 4.32a (wine), 5.32a (distilled spirits), and 7.22a (malt beverages).
The burden is on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that the finished product or class of products, as derived by the method specified in the petition either: (1) does not cause an allergic response that poses a risk to human health; or (2) does not contain allergenic protein derived from one of the foods identified in the definition of 'major food allergen', even though a major food allergen was used in production.
According to the interim regulations, the TTB will approve or deny a petition for exemption in writing within 180 days of receipt of the petition. See 27 CFR 4.32b (wine), 5.32b (distilled spirits), and 7.22b (malt beverages) for additional details of the petition process.
TTB Also Issues Proposed Rule on Mandatory Labeling of Major Food Allergens
In addition to this interim rule, the TTB has also issued a companion proposed rule1 which would adopt mandatory labeling requirements for major food allergens used in the production of wines, distilled spirits, and malt beverages. Comments on this proposed rule are due by September 25, 2006. See future issue of ITT for BP summary of this proposed rule.
(1In April 2005, the TTB published an advance notice of proposed rulemaking (ANPR) which solicited comments from various stakeholders concerning allergen labeling as well as calorie and carbohydrate claims on labels, serving facts labeling, alcohol facts labeling, ingredient labeling, etc. The TTB states that while the ANPR generated a large number of comments, relatively few addressed allergen labeling and most of these comments favored such labeling. In light of the small number of comments received and other factors, the TTB decided to separate the allergen labeling rulemaking from the other issues discussed in the ANPR.)
TTB Contact - Lisa Gesser (301) 290-1460
TTB Interim Rule (T.D TTB-53; Re: Notice No. 62, FR Pub 07/26/06) available athttp://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-11872.pdf
TTB Proposed Rule (Notice No. 62, FR Pub 07/26/06) available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-6467.pdf