Labeling of Major Food Allergens and Petitions for Exemption

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
OMB No. 1513-0121 Supporting Statement (04-2024).docx	Supporting Statement A	Uploaded 2024-04-02	Repair queued
H.R. Rpt. 108-608.pdf	Supplementary Document	Uploaded 2017-10-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
228663	Petitions for Exemption from Major Food Allergen Labeling		Modified
228662	Labeling of Major Food Allergens		Modified

ICR Details

OMB Control No: 1513-0121	ICR Reference No: 202402-1513-001
Status: Active	Previous ICR Reference No: 202102-1513-001
Agency/Subagency: TREAS/TTB	Agency Tracking No: ICN 92 - 10/10
Title: Labeling of Major Food Allergens and Petitions for Exemption
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/10/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/29/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	06/30/2024
Responses	215	0	700
Time Burden (Hours)	241	0	566
Cost Burden (Dollars)	50	0	50

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Abstract: 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 not present in the finished product at levels that would 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 while allowing bottlers to avoid consumer confusion by exempting from disclosure allergens that, while used in a product’s production, are not present in the finished product at levels that would pose a risk to human health.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 6563	02/01/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 33468	04/29/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

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

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	215	700	0	0	-485	0
Annual Time Burden (Hours)	241	566	0	0	-325	0
Annual Cost Burden (Dollars)	50	50	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There are no program changes associated with this information collection request at this time. As for adjustments, due to changes in agency estimates resulting from improved data analysis, TTB is decreasing the estimated annual burden associated with the allergen labeling portion of this collection, from 695 respondents to 35, and from 466 total burden hours to 140.7. However, TTB is increasing the estimated number of responses per respondent from 1 to 6 responses annually. The estimated annual burden for the exemption petition portion of this collection remains the same as previously reported (5 respondents and responses, 1 annual response per respondent, and 100 total burden hours).

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Annual Cost to Federal Government: $2,705

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/29/2024

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