TTB Proposes Requirements for Major Food Allergen Labeling Used in the Production of Alcohol Beverages

TTB explains that the regulations contained in this proposed rule parallel the recent amendments to the Federal Food, Drug and Cosmetic Act contained in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). (See ITT's Online Archives or 01/18/06 news, (Ref:06011820), for BP summary of the FALCPA, which went into effect for food products on January 1, 2006.)

TTB Interim Rule on Voluntary Labeling of Major Food Allergens in Effect

In addition to this proposed rule, the TTB has also issued a companion interim rule, which took effect July 26, 2006, that sets 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. The standards for voluntary labeling closely follow the below-described proposed requirements for labeling of such allergens. (See ITT's Online Archives or 09/06/06 news, 06090625, for BP summary of the interim rule on voluntary labeling of major food allergens.)

Highlights of TTB's Proposed Standards for Labeling of Major Food Allergens

The following are highlights of TTB's proposed standards that producers, bottlers, and importers would have to follow in order to declare the presence of major food allergens in wines, distilled spirits and malt beverages (partial list):

Definition of 'major food allergen.' TTB's proposed 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 (e.g. peanut oil). This definition would provide for the exemption of certain ingredients which have been granted an exemption through a petition process (see below).

Allergen declaration would be located on label. The TTB states that major food allergens would have to be declared on a label affixed to the container.

Manner in which major food allergens must be declared. TTB states that the major food allergens declaration would have to 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").

Allowable names for certain major food allergens. The proposed rule would allow the terms "soybean", "soy", and "soya" as synonyms for the term "soybeans" as used in the statute. Furthermore, the singular term "peanut" could be substituted for the plural term "peanuts" and singular terms (for example, almond, pecan, or walnut) may be used in place of plural terms to describe the different types of tree nuts. These policies would be consistent with the guidance provide by the FDA to the food industry.

Proposed 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 proposed rule is consistent with FALCPA with respect to labeling of tree nuts and Crustacean shellfish; however, it would not require labeling of the specific finfish species. Instead, the proposed regulations would 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 would have to be declared. The TTB states that the proposed 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.

Proposed 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 proposing any thresholds in this proposed regulation. TTB states that this position would ensure that consumers 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 proposed rule states that any person may petition the appropriate TTB officer to exempt a particular product or class of products from the labeling requirements contained in the proposed rule's version of 27 CFR 4.32a (wine), 5.32a (distilled spirits), and 7.22a (malt beverages).

The burden would be 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 proposed regulations, the TTB would approve or deny a petition for exemption in writing within 180 days of receipt of the petition. See the proposed rule's version of 27 CFR 4.32b (wine), 5.32b (distilled spirits), and 7.22b (malt beverages) for additional details of the petition process.

TTB does not anticipate requiring industry members to apply for new COLAs. Although the proposed regulatory texts do not specifically address this issue, the TTB anticipates that it would not require an industry member to apply for a new Certification/Exemption of Label/Bottle Approval (COLA) for a product before adding major food allergen declarations to the label. TTB believes this policy would foster compliance and ease administrative burdens. Under such a policy, a COLA valid at the time the final rule went into effect would not become invalid because of the new regulatory texts. However, industry members could apply for new COLAs if they wish. They also would have an opportunity to obtain guidance from TTB on how to add these additional allergen statements to their labels.

TTB Solicits Comments on Costs Associated With Mandatory Allergen Labeling

Among other things, the TTB is soliciting comments directed specifically to the costs and benefits of the proposed mandatory labeling of major food allergens and on ways to reduce the costs to industry, in particular small businesses. Any business that believes it would be adversely impacted by the proposed rule should provide TTB with specific cost figures. TTB also solicits comments on any alternative approach that would meet the intent of FALCPA while minimizing the costs imposed on industry members. In addition, the TTB seeks comments on how much time industry requires to comply with the proposed labeling requirements.

Proposed Rule Stems from April 2005 ANPR on Various Labeling Issues

In 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.

- Written comments are due by September 25, 2006

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