Labeling of Major Food Allergens and Petitions for Exemption

Forms and Documents

Document Name	Status
H.R. Rpt. 108-608.pdf Supplementary Document	2017-10-18
1513-0121 Supporting Statement (10-2017).docx Supporting Statement A	2017-10-18
TTB Allergen Labeling and Exemption Petition Regulations.docx Supplementary Document	2017-10-16

IC Document Collections

IC ID	Document Title	Status
43841	Labeling of major food allergens and Petitition of Exemption	Removed
228663	Petitions for Exemption from Major Food Allergen Labeling	New
228662	Labeling of Major Food Allergens	New

ICR Details

OMB Control No: 1513-0121	ICR Reference No: 201710-1513-008
Status: Active	Previous ICR Reference No: 201407-1513-001
Agency/Subagency: TREAS/TTB	Agency Tracking No: ICN 65 - 8/8
Title: Labeling of Major Food Allergens and Petitions for Exemption
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/28/2018
	Date Received in OIRA: 10/26/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved	02/28/2018
Responses	645	0	520
Time Burden (Hours)	527	0	730
Cost Burden (Dollars)	42,000	0	64,750

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Abstract: The Federal Alcohol Administration Act (FAA Act) at 27 U.S.C. 205(e) authorizes the Secretary to issue regulations regarding the labeling of wine, distilled spirits, and malt beverages 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 this authority, the TTB regulations allow for the voluntary labeling of major food allergens (as defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (118 Stat. 905)) used in the production of alcohol beverages. The regulations require that, if any one major food allergen is voluntarily declared, all major food allergens used in the product must be declared, except when TTB has approved a petition for exemption from such labeling. This information collection includes the labeling of allergens and petitions for exemption.

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

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:
	82 FR 32441	07/13/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 49701	10/26/2017
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Labeling of major food allergens and Petitition of Exemption
Petitions for Exemption from Major Food Allergen Labeling
Labeling of Major Food Allergens

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ICR Summary 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	645	520	0	0	125	0
Annual Time Burden (Hours)	527	730	0	0	-203	0
Annual Cost Burden (Dollars)	42,000	64,750	0	0	-22,750	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There are no program changes associated with this collection. As for adjustments, in the past TTB has reported the two elements of this information collection request–labeling of major allergens and petitions for exemption—as one information collection. However, as a matter of agency discretion, TTB is now reporting these two elements as separate information collections under this information collection request. TTB believes this is necessary to properly account for the differing data collected by each collection and the significantly differing number of respondents, responses, and costs associated with each of these information collections. In addition, due to changes in agency estimates, TTB is increasing the number of respondents and responses to the labeling of major food allergen information collection, from 500 to 640, which results in an increase of 97 hours in annual burden, from 330 to 427 hours. These increases are due to the increase in the number of alcohol beverage producers making disclosures of major food allergens on alcohol beverage labels. However, TTB is decreasing the estimated number of respondents and responses to the petition for exemption information collection, from 20 to 5 annual responses, which results in a decrease of 300 hours in annual burden for this information collection. To date, TTB has received no petitions for exemption, and, as such, TTB believes it has over-estimated the number of such petitions that it may receive during a given year. Therefore, the overall estimated burden for this information collection has decreased from 730 hours to 527 hours, a decrease of 203 hours.

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Annual Cost to Federal Government: $2,540

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? Uncollected

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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: 10/26/2017

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