Labeling of Major Food Allergens and Petitions for Exemption

ICR 202102-1513-001

OMB: 1513-0121

Federal Form Document

Forms and Documents
Supporting Statement A
Supplementary Document
IC Document Collections
ICR Details
1513-0121 202102-1513-001
Received in OIRA 201710-1513-008
TREAS/TTB ICN 81 - 11/11
Labeling of Major Food Allergens and Petitions for Exemption
Extension without change of a currently approved collection   No
Regular 02/22/2021
  Requested Previously Approved
36 Months From Approved 02/28/2021
700 645
566 527
50 42,000

The Federal Alcohol Administration Act (FAA Act) at 27 U.S.C. 205(e) authorizes the Secretary of the Treasury to issue regulations regarding the labeling of distilled spirits, wines containing 7 percent or more alcohol by volume, and beer that is made with both malted barley and hops in order to, among other things, prohibit consumer deception and ensure that labels provide consumers with adequate information as to the identity and quality of such products. Under that authority, the TTB regulations provide for the voluntary labeling of major food allergens used in the production of such alcohol beverages. (As defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (118 Stat. 905), the major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.) Under the TTB regulations, if an alcohol beverage bottler declares any one major food allergen contained in a product or used in its production, the bottler must declare all such allergens, including those used as fining or processing agents. However, the regulations allow a bottler to petition TTB for a labeling exemption for an allergen if evidence shows that, while used in the product's production, it is present in the finished product at levels that would not pose a risk to human health. This information collection allows bottlers to alert consumers sensitive to major food allergens to their presence in finished alcohol beverages.

Statute at Large: 118 Stat. 905 Name of Statute: Food Allergen Labeling and Consumer Protection Act of 2004
   US Code: 27 USC 205(e) Name of Law: Federal Alcohol Administration Act

Not associated with rulemaking

  85 FR 69680 11/03/2020
86 FR 10434 02/19/2021

IC Title Form No. Form Name
Petitions for Exemption from Major Food Allergen Labeling
Labeling of Major Food Allergens

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 700 645 0 0 55 0
Annual Time Burden (Hours) 566 527 0 0 39 0
Annual Cost Burden (Dollars) 50 42,000 0 0 -41,950 0
There are no program changes associated with this information collection at this time. As for adjustments, TTB is increasing the estimated annual burden associated with the allergen labeling portion of this collection, from 645 respondents and responses to 695, and from 427 hours to 466. These increases are due to an increase in the number of alcohol beverage bottlers making voluntary food allergen labeling disclosures. In addition, TTB is adjusting the respondent costs previously reported for this collection to reflect only the annualized non-labor costs associated with this collection (see Question 13 of the Supporting Statement). We are now reporting respondent labor costs in Question 12 of the Supporting Statement.

Curtis Eilers 202 453-1039 ext. 041


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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