Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 5763 

1See page 3 of the report, available at https://

home.treasury.gov/system/files/136/CompetitionReport.pdf. 

2 Id. at page 61. 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Parts 4, 5, and 7 

[Docket No. TTB–2025–0003; Notice No. 

238] 

RIN 1513–AC94 

Major Food Allergen Labeling for 

Wines, Distilled Spirits, and Malt 

Beverages 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Alcohol and Tobacco Tax 

and Trade Bureau (TTB) proposes to 

require a labeling disclosure of all major 

food allergens used in the production of 

alcohol beverages subject to TTB’s 

regulatory authority under the Federal 

Alcohol Administration Act. Under the 

proposed regulations, unless an 

exception applies, labels must declare 

milk, eggs, fish, Crustacean shellfish, 

tree nuts, wheat, peanuts, soybeans, and 

sesame, as well as ingredients that 

contain protein derived from these 

foods, if used in the production of the 

alcohol beverage. TTB proposes a 

compliance date of 5 years from the date 

that a final rule resulting from this 

proposal is published in the Federal 

Register. 

DATES: Comments must be received on 

or before April 17, 2025. 

ADDRESSES: You may electronically 

submit comments to TTB on this 

proposal, and view copies of this 

document, its supporting materials, and 

any comments TTB receives on it, 

within Docket No. TTB–2025–0003 as 

posted at https://www.regulations.gov. 

A direct link to that docket is available 

on the TTB website at https://

www.ttb.gov/laws-and-regulations/allrulemaking under Notice No. 238. 

Alternatively, you may submit 

comments via postal mail to the 

Director, Regulations and Ruling 

Division, Alcohol and Tobacco Tax and 

Trade Bureau, 1310 G Street NW, Box 

12, Washington, DC 20005. Please see 

the Public Participation section of this 

document for further information on the 

comments requested regarding this 

proposal and on the submission, 

confidentiality, and public disclosure of 

comments. 

FOR FURTHER INFORMATION CONTACT: Curt 

Eilers, Regulations and Rulings 

Division, Alcohol and Tobacco Tax and 

Trade Bureau, 1310 G Street NW, Box 

12, Washington, DC 20005; telephone 

202–453–1039, ext. 041. 

SUPPLEMENTARY INFORMATION: In 

accordance with 5 U.S.C. 553(b)(4), a 

summary of this rule may be found at 

https://www.regulations.gov/TTB-2025- 

0003. 

I. Background 

On December 16, 2003, the Center for 

Science in the Public Interest (CSPI) and 

others petitioned the Alcohol and 

Tobacco Tax and Trade Bureau (TTB), 

requesting changes to the alcohol 

beverage labeling regulations to, among 

other things, require information about 

allergens. The following year, Congress 

enacted the Food Allergen Labeling and 

Consumer Protection Act of 2004 

(FALCPA), which amended the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) by defining what constitutes a 

‘‘major food allergen’’ (21 U.S.C. 

321(qq)) and requiring the presence of 

each major food allergen to be declared 

on the product label using the name of 

the food source from which the major 

food allergen is derived. 

On July 26, 2006, TTB published an 

interim rule, T.D. TTB–53 (71 FR 

42260), entitled ‘‘Major Food Allergen 

Labeling for Wines, Distilled Spirits and 

Malt Beverages,’’ which addressed the 

voluntary labeling of major food 

allergens used in the production of 

alcohol beverages. On that same date, 

TTB published a proposed rule, Notice 

No. 62 (71 FR 42329), seeking comments 

on mandatory allergen labeling for 

alcohol beverages. TTB did not finalize 

the proposed rule, and mandatory 

labeling of major food allergens on 

alcohol beverage labels has not been 

adopted. 

In 2021, TTB received a letter, dated 

February 24, 2021, from several 

consumer groups and public health 

advocates, including CSPI, Alcohol 

Justice, the American Institute for 

Cancer Research, Breast Cancer 

Prevention Partners, the Consumer 

Federation of America, the National 

Consumers League, and the U.S. 

Alcohol Policy Alliance. The letter 

urged the Secretary of the Treasury to 

adopt regulations to mandate a 

standardized label that would include 

additional information about calories, 

standard drinks, and advice on 

moderate drinking from the U.S. 

Department of Agriculture and U.S. 

Department of Health and Human 

Service’s Dietary Guidelines for 

Americans. The letter also urged the 

identification of any major food 

allergens present in the product and an 

ingredient declaration that lists each 

ingredient by its common or usual 

name. 

On February 9, 2022, the Department 

of the Treasury, in consultation with the 

Department of Justice and the Federal 

Trade Commission, released a report 

entitled ‘‘Competition in the Markets for 

Beer, Wine, and Spirits’’ (Competition 

Report). The Competition Report was 

requested by Executive Order 14036, 

‘‘Promoting Competition in the 

American Economy’’. One of the 

Competition Report’s findings was that 

‘‘[r]egulatory proposals that could serve 

public health and foster competition by 

providing information to consumers, 

such as mandatory allergen, nutrition, 

and ingredient labeling proposals, have 

not been implemented.’’ 1 The 

Competition Report contains several 

recommendations, including that ‘‘TTB 

should revive or initiate rulemaking 

proposing ingredient labeling and 

mandatory information on alcohol 

content, nutritional content, and 

appropriate serving sizes.’’ 2

Consistent with the Competition 

Report’s recommendations, and 

considering the February 2021 letter 

referenced above, TTB decided to revisit 

the issue of mandatory allergen labeling 

for alcohol beverages. In addition, TTB 

had received several comments in favor 

of reopening this issue during the public 

comment period for proposals to 

modernize alcohol beverage labeling in 

2018. See Notice No. 176, 83 FR 60562, 

November 26, 2018. Because it has been 

almost 20 years since TTB solicited 

comments on allergen labeling, TTB 

published Notice No. 232, which 

announced two virtual listening 

sessions, on February 28 and 29, 2024, 

and the opening of a docket to receive 

public input on labeling of wine, 

distilled spirits, and malt beverages 

with per-serving alcohol and nutritional 

information, major food allergens, and/ 

or ingredients. 

TTB is now publishing for public 

comment a new proposal that would 

require allergen labeling for wines, 

distilled spirits, and malt beverages. 

TTB is addressing the Competition 

Report’s recommendations and Notice 

No. 232 comments from the listening 

sessions on mandatory alcohol facts and 

ingredient labeling in separate 

rulemaking projects. 

II. TTB’s Authority To Regulate Alcohol 

Beverage Labeling 

A. TTB’s Statutory Authority Under the 

FAA Act 

TTB is responsible for the 

administration of the Federal Alcohol 

Administration Act, 27 U.S.C. 201 et 

seq. (FAA Act), which sets forth 


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3The evidence FDA considered showed a need to 

alert certain individuals with specific medical 

conditions to the presence of phenylalanine in 

products containing aspartame. This statement is 

directed towards individuals with Phenylketonuria 

(PKU), an inherited disorder of the metabolism of 

phenylalanine, who need to carefully restrict their 

phenylalanine intake. 

4As explained further in this document, FALCPA 

provides exemptions for any highly refined oil 

derived from a major food allergen and any 

ingredient derived from such a highly refined oil, 

and for food ingredients that are exempt from major 

food allergen labeling requirements pursuant to a 

standards for the regulation of the 

labeling of wine (containing at least 7 

percent alcohol by volume), distilled 

spirits, and malt beverages that will be 

sold or otherwise introduced in 

interstate or foreign commerce. (This 

document generally refers to these 

products as ‘‘alcohol beverages.’’) 

Section 105(e) of the FAA Act (27 U.S.C. 

205(e)) gives the Secretary authority to 

issue labeling regulations to prevent 

deception of the consumer, to provide 

the consumer with ‘‘adequate 

information’’ as to the identity, quality, 

and alcohol content of the product, and 

to prohibit false or misleading 

statements. Additionally, the FAA Act 

gives the Secretary the authority to 

prohibit, irrespective of falsity, labeling 

statements relating to age, 

manufacturing processes, analyses, 

guarantees, and scientific or irrelevant 

matters which are likely to mislead the 

consumer. In the case of malt beverages, 

the labeling provisions of the FAA Act 

apply only if the laws or regulations of 

the State into which the malt beverages 

are to be shipped impose similar 

requirements. 

The FAA Act generally requires 

bottlers and importers to obtain a 

certificate of label approval (COLA) 

from TTB prior to bottling wine, 

distilled spirits, or malt beverages for 

introduction into interstate commerce, 

or removing alcohol beverages from 

customs custody, in bottles, for sale or 

any other commercial purpose. The law 

provides that COLAs are to be issued in 

such manner and form as the Secretary 

shall prescribe by regulations. 

TTB administers the FAA Act 

provisions pursuant to section 1111(d) 

of the Homeland Security Act of 2002, 

codified at 6 U.S.C. 531(d). In addition, 

the Secretary of the Treasury has 

delegated certain administrative and 

enforcement authorities to TTB through 

Treasury Order 120–01. 

Current TTB regulations do not 

require the disclosure of ingredients or 

major food allergens on alcohol 

beverage labels. However, as explained 

in the next section, labels must disclose 

the presence of FD&C Yellow No. 5, 

cochineal extract or carmine, sulfites, 

and aspartame for health-related 

reasons. A health warning statement 

applicable to all alcohol beverages 

containing 0.5 percent or more alcohol 

by volume is also required by the 

Alcoholic Beverage Labeling Act of 

1988, codified at 27 U.S.C. 213–219 and 

219a and implemented in the TTB 

regulations at 27 CFR part 16. 

B. Current Ingredient Disclosures on 

Alcohol Beverage Labels 

TTB’s predecessor agency, the Bureau 

of Alcohol, Tobacco, and Firearms 

(ATF), proposed on several occasions to 

adopt mandatory ingredient disclosure 

requirements for alcohol beverages. In 

each case, ATF ultimately decided not 

to adopt full ingredient labeling 

requirements. (See Notice No. 41, 70 FR 

22274, April 29, 2005, for a more 

complete history of those ingredient 

labeling regulatory initiatives.) 

In 1980, ATF published regulations 

that required ingredient labeling for 

alcohol beverages, with a delayed 

effective date. See T.D. ATF–66 (45 FR 

40538, June 13, 1980). ATF 

subsequently rescinded those 

regulations before they went into effect. 

See T.D. ATF–94 (46 FR 55093, 

November 6, 1981). CSPI and others 

challenged this action in court. ATF 

subsequently undertook a new round of 

rulemaking, and issued another final 

rule, T.D. ATF–150 (48 FR 45549, 

October 6, 1983), which rescinded 

ingredient labeling but mandated the 

disclosure of one ingredient, FD&C 

Yellow No. 5, on alcohol beverage 

labels. In the preamble to T.D. ATF–150, 

ATF stated that there was ‘‘no clear 

evidence in the record that any other 

ingredient besides FD&C Yellow No. 5 

poses any special health problem. The 

Department will look at the necessity of 

mandatory labeling of other ingredients 

on a case-by-case basis through its own 

rulemaking initiative, or on the basis of 

petitions for rulemaking. . . .’’ 

Ultimately, the D.C. Circuit Court of 

Appeals upheld ATF’s actions in 

rescinding mandatory ingredient 

labeling in favor of a policy that would 

require the agency to consider the 

necessity of mandatory labeling of 

specific ingredients on a case-by-case 

basis. See Center for Science in the 

Public Interest v. Department of the 

Treasury, 797 F.2d 995, 1004 (D.C. Cir. 

1986). 

Consistent with that case-by-case 

review policy, ATF subsequently 

undertook rulemaking that resulted in 

the issuance of regulations requiring the 

disclosure on labels of sulfites in 

alcohol beverages (T.D. ATF–236, 51 FR 

34706, September 30, 1986) because it 

was determined that the presence of 

undeclared sulfites in alcohol beverages 

posed a recognized health problem to 

sulfite-sensitive individuals. See 27 CFR 

4.32, 5.63, and 7.63. 

In 1987, ATF entered a Memorandum 

of Understanding (MOU) with the U.S. 

Food and Drug Administration (FDA) 

which continues in effect. See Notice 

No. 648 (52 FR 45502, November 30, 

1987). The MOU states that ATF would 

initiate rulemaking proceedings to 

promulgate labeling regulations for 

alcohol beverages when FDA 

determined that the presence of an 

ingredient in food products, including 

alcohol beverages, posed a recognized 

public health problem and that the 

ingredient must be identified on a food 

product label. 

Pursuant to the policies set forth in 

the MOU, and based on FDA 

determinations as reflected in its 

regulations, ATF, and later TTB, 

subsequently engaged in rulemaking 

that resulted in regulations requiring a 

declaration on labels when aspartame is 

used in the production of malt 

beverages (T.D. ATF–347, 58 FR 44131, 

August 19, 1993) and distilled spirits 

(T.D. TTB–176, 87 FR 7526, February 9, 

2022). The following statement must 

appear in capital letters, separate and 

apart from all other information: 

‘‘PHENYLKETONURICS: CONTAINS 

PHENYLALANINE.’’ 3 On April 16, 

2012, TTB amended its regulations to 

require alcohol beverage labels to 

disclose the presence of cochineal 

extract and carmine so consumers who 

are allergic to these color additives 

would be able to identify and thus avoid 

alcohol beverage products that contain 

them. See T.D. TTB–103 (77 FR 22485, 

April 16, 2012). See also 27 CFR 4.32, 

5.63, and 7.63. 

C. Enactment of FALCPA 

In 2004, Congress enacted the Food 

Allergen Labeling and Consumer 

Protection Act of 2004 (FALCPA). 

FALCPA amended the Federal Food, 

Drug and Cosmetic Act (FD&C Act) to 

require food labels to declare the 

presence of each major food allergen 

using the name of the food source from 

which the major food allergen is 

derived. For example, instead of merely 

listing ‘‘semolina,’’ the label must also 

list ‘‘wheat,’’ and instead of merely 

listing ‘‘sodium casein,’’ the label must 

also list ‘‘milk.’’ The 2004 FALCPA 

amendments defined ‘‘major food 

allergens’’ as milk, egg, fish, Crustacean 

shellfish, tree nuts, wheat, peanuts, and 

soybeans, as well as most ingredients 4


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petition for exemption approved by FDA under 21 

U.S.C. 343(w)(6) or pursuant to a notice submitted 

to FDA under 21 U.S.C. 343(w)(7), provided that the 

food ingredient meets the terms or conditions, if 

any, specified for that exemption. 

containing proteins derived from these 

foods. 

The FALCPA amendments provide 

two ways for a manufacturer to disclose 

major food allergens on the label: 

• The label can show the name of the 

food source from which the major food 

allergen is derived within parentheses 

in the ingredient list, for example, 

‘‘Ingredients: Water, wheat, whey 

(milk), albumen (eggs), and peanuts.’’ 

• The label can list the name of the 

food source from which the allergen is 

derived in a ‘‘Contains’’ statement after, 

or adjacent to, an ingredient list, for 

example: ‘‘Ingredients: Water, sugar, 

whey, and albumen. Contains Milk and 

egg.’’ 

The label can also declare the allergen 

in the ingredient list as well as in a 

‘‘Contains’’ statement but when this 

occurs, the ‘‘Contains’’ statement must 

be complete, which means that the 

‘‘Contains’’ statement must include all 

the major food allergens in the product. 

The allergen labeling requirements in 

FALCPA apply to any packaged FDAregulated food, as that term is defined 

in section 201(f) of the FD&C Act, other 

than raw agricultural commodities. 

However, the FAA Act assigns TTB 

jurisdiction to regulate the labeling of 

wine, distilled spirits, and malt 

beverages. See Brown-Forman Distillers 

Corp. v. Mathews, 435 F. Supp. 5 (W.D. 

Ky. 1976) and 1987 MOU with FDA. 

In its report on FALCPA, the House of 

Representatives Committee on Energy 

and Commerce recognized that FALCPA 

does not apply to alcohol beverages 

regulated by TTB under the FAA Act 

and called for TTB to work with FDA 

to promulgate appropriate allergen 

labeling regulations, consistent with the 

1987 MOU with FDA. The committee 

report accompanying FALCPA stated: 

The Committee expects, consistent with 

the November 30, 1987 Memorandum of 

Understanding, that the Alcohol and Tobacco 

Tax and Trade Bureau (TTB) of the 

Department of Treasury will pursuant to the 

Federal Alcohol Administration Act 

determine how, as appropriate, to apply 

allergen labeling of beverage alcohol 

products and the labeling requirements for 

those products. The Committee expects that 

the TTB and the FDA will work together in 

promulgation of allergen regulations, with 

respect to those products. 

H.R. Rep. No. 608, 108th Cong., 2d 

Sess., at 3 (2004) (hereafter ‘‘House 

committee report’’). Congress thus 

recognized TTB’s longstanding policy of 

consulting with FDA in determining 

what ingredients in alcohol beverages 

should be disclosed on labels and 

indicated that TTB should issue 

appropriate allergen regulations for 

alcohol beverage products, pursuant to 

the policies expressed in the MOU with 

FDA and the authority of the FAA Act. 

Consistent with the expectations 

expressed in the House committee 

report, TTB consulted with FDA prior to 

issuing this proposed rule. However, 

TTB’s legal authority to issue 

regulations on allergen labeling of 

alcohol beverages is based on the FAA 

Act, and thus differs in some respects 

from the requirements of FALCPA. 

Accordingly, this proposed rule reflects 

TTB’s interpretation of its authority 

under the FAA Act, as informed by the 

language in the House committee report. 

The proposed regulations do not 

necessarily represent the views of FDA 

regarding allergen labeling or the 

requirements of FALCPA. One of the 

key differences between the food 

labeling regulations implemented by 

FDA and the alcohol beverage labeling 

regulations implemented by TTB is that 

the TTB regulations currently do not 

require the disclosure of all ingredients 

on labels. As explained later in this 

document, this is especially important 

because there are many allergens other 

than the major food allergens identified 

in FALCPA. 

III. Rulemaking History 

A. 2005 Advance Notice of Proposed 

Rulemaking 

Consistent with the FALCPA House 

committee report, on April 29, 2005, 

TTB published in the Federal Register 

(70 FR 22274) Notice No. 41, an advance 

notice of proposed rulemaking 

(ANPRM) entitled ‘‘Labeling and 

Advertising of Wines, Distilled Spirits 

and Malt Beverages; Request for Public 

Comment.’’ Notice No. 41 sought public 

comment on a wide range of alcohol 

beverage labeling and advertising issues 

to help TTB determine what regulatory 

changes in alcohol beverage labeling 

and advertising requirements, if any, 

TTB should propose in future 

rulemaking documents. These included 

calorie and carbohydrate claims, 

‘‘Serving Facts’’ or ‘‘Alcohol Facts’’ 

statements, ingredient labeling, and 

allergen labeling. TTB invited 

comments on specific issues related to 

allergen labeling, including: 

• Whether TTB regulations should 

require allergen labeling to be part of or 

adjacent to a list of ingredients, similar 

to the FALCPA requirements; 

• Whether an allergen must be 

labeled in an allergen statement even 

when the allergen name already appears 

in the product name; 

• How processing or fining agents 

should be labeled; 

• Whether TTB should consider 

threshold levels in allergen labeling; 

• What costs industry might incur 

from new labeling requirements; and 

• How consumers might benefit from 

allergen labeling. 

TTB also invited submission of any 

other relevant information about 

allergen labeling. 

TTB received over 19,000 comments 

in response to the ANPRM, 

approximately 50 of which specifically 

addressed the subject of allergen 

labeling. Of those, the vast majority 

favored mandatory labeling of the major 

food allergens. Industry members, 

including major trade associations, as 

well as consumer and public health 

advocates commented in support of 

major food allergen labeling. Although 

commenters took different positions on 

some of the specific issues TTB sought 

comment on in the ANPRM, only a few 

comments questioned the usefulness of 

requiring allergen information on 

alcohol beverage labels. 

B. 2006 Interim Rule on Voluntary 

Allergen Labeling 

While TTB is not reproposing its 2006 

interim regulations which established 

standards for voluntary labeling of 

major allergens, there are similarities in 

this proposal, such as the procedures for 

obtaining an exemption, that warrant a 

brief summary of the 2006 regulations. 

Under the interim regulations, 

producers, bottlers, and importers of 

wines, distilled spirits, and malt 

beverages may voluntarily declare on 

their labels the presence of milk, eggs, 

fish, Crustacean shellfish, tree nuts, 

wheat, peanuts, and soybeans, as well as 

ingredients that contain protein derived 

from these foods. However, if industry 

members choose to disclose allergens, 

the interim regulations set forth 

mandatory rules on how to undertake 

those disclosures—unless one of three 

exceptions applies. 

Two of these exceptions from major 

food allergen labeling are based on 

FALCPA’s definition of the term ‘‘major 

food allergen,’’ which excludes both 

highly refined oil and food ingredients 

exempt from allergen labeling under the 

FDA procedures at 21 U.S.C. 343(w)(6) 

and (7). The third is an exemption 

through a TTB petition process created 

by the interim regulations. All three are 

described in the following paragraphs. 

The original FALCPA definition of 

‘‘major food allergen’’ excluded any 

highly refined oil derived from one of 

the eight foods or food groups listed in 


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5On April 23, 2021, the President signed the 

Food Allergy Safety, Treatment, Education, and 

Research (FASTER) Act into law, declaring sesame 

as the ninth major food allergen. Accordingly, there 

are now nine major food allergens described in 21 

U.S.C. 321(qq). 

that definition and any ingredient 

derived from such highly refined oil.5

TTB included this as an exception from 

the definition of a major food allergen 

in the interim regulations. 

The second FALCPA exclusion from 

the definition of ‘‘major food allergen’’ 

arises from two processes FALCPA 

added to the FD&C Act at 21 U.S.C. 

343(w)(6) and (7), by which any person 

may obtain an exemption from the 

allergen labeling requirements imposed 

by the statute. Subsection (w)(6) allows 

any person to petition the Secretary of 

Health and Human Services to exempt 

a food ingredient from the allergen 

labeling requirements. Under its 

delegated authority, FDA performs the 

function of the Secretary in this area. In 

this situation, the burden is on the 

petitioner to provide scientific evidence 

(including the analytical method used to 

produce the evidence) that demonstrates 

that the food ingredient, as derived by 

the method specified in the petition, 

does not cause an allergic response that 

poses a risk to human health. FDA must 

approve or deny any such petition 

within 180 days of receipt, or the 

petition will be deemed denied, unless 

an extension is mutually agreed upon by 

FDA and the petitioner. 

Subsection (w)(7) allows any person 

to file a notification containing 

scientific evidence demonstrating that a 

food ingredient ‘‘does not contain 

allergenic protein.’’ The scientific 

evidence must include the analytical 

method used to produce the evidence 

that the food ingredient, as derived by 

the method specified in the notification, 

does not contain allergenic protein. 

Alternatively, the notification may 

contain a determination from FDA 

under a premarket approval or 

notification program provided for in 

section 409 of the FD&C Act (21 U.S.C. 

348) that the food ingredient does not 

cause an allergic response that poses a 

risk to human health. FDA has 90 days 

to object to a notification. Absent an 

objection, the food ingredient may be 

introduced or delivered for introduction 

into interstate commerce as a food 

ingredient that is not a major food 

allergen. 

Many ingredients and food additives 

used in the production of foods 

regulated by FDA are also used in the 

production of alcohol beverages 

regulated by TTB. Accordingly, the 

interim regulations included in the 

definition of the term ‘‘major food 

allergen’’ an exception for uses of food 

ingredients that are exempt pursuant to 

21 U.S.C. 343(w)(6) or (7) discussed 

above. Alcohol beverage industry 

members also must establish that the 

proposed use of the ingredient is 

consistent with any conditions of use in 

the FD&C Act exemption for the 

ingredient. 

As noted above, the interim 

regulations’ third exception from 

allergen labeling is through a TTB 

petition process. TTB recognized that 

major food allergens are used in alcohol 

beverage production in ways that may 

differ from the way they are used in the 

production of foods regulated by FDA. 

For this reason, the interim regulations 

refer to an exception for a product 

covered by a petition for exemption 

approved by TTB. See 27 CFR 4.32a–b, 

5.82–5.83, and 7.82–7.83. A petition 

may pertain to the use of a major food 

allergen in the production of one 

specific alcohol beverage product or it 

may pertain to a class of products using 

a particular process involving a major 

food allergen. 

The TTB petition process is like that 

of the petition and notification 

processes provided for at 21 U.S.C. 

343(w)(6) and (7), except that the TTB 

petition procedure focuses on finished 

products instead of ingredients. The 

TTB petition process may be used: 

• When it is asserted that the product 

or class of products, as derived by the 

method specified in the petition, does 

not cause an allergic response that poses 

a risk to human health; or 

• When it is asserted that the product 

or class of products, as derived by the 

method specified in the petition, does 

not contain allergenic protein, even 

though a major food allergen was used 

in production. 

The interim TTB regulations provide 

for only a petition procedure, rather 

than both the petition procedure and the 

notification procedure provided for in 

the FALCPA amendments to the FD&C 

Act. In addition, the interim regulations 

provide that if TTB does not approve or 

deny the petition for exemption within 

180 days of receipt, the petition is 

deemed denied, unless an extension of 

time is mutually agreed upon by TTB 

and the petitioner. TTB’s petition 

procedure is therefore like the petition 

procedure in 21 U.S.C. 343(w)(6) in that 

both procedures place the burden on the 

petitioner to provide evidence in 

support of the exemption and give the 

agency 180 days to respond. 

The regulations also provide that a 

determination under this section 

constitutes a final agency action and 

that even though a petition is deemed 

denied because no action was taken 

within the 180-day period, the 

petitioner may resubmit the petition at 

any time. A resubmitted petition will be 

treated as a new petition. 

C. 2006 Proposed Rule on Mandatory 

Allergen Labeling 

As noted above, on the same date that 

TTB published interim regulations on 

the voluntary labeling of major food 

allergens, the agency also published 

Notice No. 62 (71 FR 42329 July 26, 

2006), proposing to adopt mandatory 

alcohol beverage labeling requirements 

when one or more major food allergens, 

or ingredients derived from such 

allergens, are used in the production of 

the alcohol beverage. The proposed 

regulations were almost identical to 

those in the interim rule, except where 

necessary to note that major food 

allergen labeling would be mandatory. 

The proposed regulations set forth the 

same procedures for petitioning for an 

exemption from allergen labeling. 

TTB received 51 comments in 

response to Notice No. 62. While most 

commenters were generally supportive 

of mandatory allergen labeling, concerns 

were raised about various 

implementation issues, including the 

absence of thresholds for the testing of 

finished alcohol beverages to determine 

if the products contained major food 

allergens; whether distillation should be 

recognized as a process that removed 

allergenic proteins; and the treatment of 

fining agents or processing aids, such as 

eggs, used in the production of alcohol 

beverages and then filtered out so that 

only trace amounts of the major food 

allergen remained in the finished 

product. While TTB did not finalize the 

2006 proposed rule on mandatory 

allergen labeling, the interim regulations 

providing for voluntary allergen labeling 

remain in effect. 

IV. Reasons for Issuing a New Notice on 

Mandatory Allergen Labeling 

A. Comments in Response to Notice No. 

176 

On November 26, 2018, TTB 

published in the Federal Register 

Notice No. 176 (83 FR 60562), 

‘‘Modernization of the Labeling and 

Advertising Regulations for Wine, 

Distilled Spirits, and Malt Beverages,’’ 

which sought comments on the 

modernization of the labeling 

regulations, but specifically stated that 

it would not address issues such as 

ingredient or allergen labeling. 

Nonetheless, TTB received several 

comments critical of that omission. 

Some of these comments specifically 

addressed mandatory allergen labeling. 


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6See page 3 of the Competition Report, available 

at https://home.treasury.gov/system/files/136/ 

Competition-Report.pdf. 

7 Id. at page 61. 

On February 22, 2019, CSPI, the 

Consumer Federation of America, and 

the National Consumers League 

commented on Notice No. 176 in a letter 

directed to the Secretary of the 

Treasury. The comment stated that 

while the consumer organizations 

supported the modernization of the 

labeling regulations, Notice No. 176 

‘‘falls dramatically short of what is 

needed to truly ‘modernize’ alcohol 

labeling by failing to require uniform 

disclosure of key information—alcohol 

content, serving size, calories, 

ingredients, and allergen information— 

that consumers need to make informed 

choices.’’ 

The comment stated that ‘‘TTB has 

similarly failed to follow through on 

protections for consumers with food 

allergies. Disclosure of allergen 

information can have life-and-death 

consequences for some consumers, a 

harsh reality that led to passage of 

[FALCPA], which requires allergen 

labeling for FDA-regulated foods and 

beverages.’’ The comment questioned 

why TTB had issued only an interim 

rule on voluntary allergen labeling, 

given that in its rulemaking, TTB noted 

that the major trade associations had 

expressed support for mandatory 

labeling of major food allergens. The 

comment suggested that the voluntary 

disclosure allowed by the interim rule 

‘‘creates a patchwork system that leaves 

consumers guessing. It may actually 

undermine public health to the extent 

that consumers with allergies may 

assume that an alcoholic beverage is 

safe to drink if its label has no allergen 

content declaration, when in fact the 

manufacturer simply has not bothered 

to label allergens that may be present.’’ 

The Brewers Association also urged 

TTB to adopt mandatory allergen 

labeling, stating that ‘‘the allergen 

disclosures required by FALCPA should 

be included in the mandatory 

information on malt beverage labels.’’ 

The comment also stated that if TTB did 

not address allergen labeling in this 

rulemaking, the issue warranted a 

separate rulemaking in the future. On 

the other hand, the Distilled Spirits 

Council of the United States (DISCUS) 

stated that it supported the proposal to 

maintain the existing rule on voluntary 

allergen labeling and suggested that 

‘‘TTB should continue to point to FDA 

as the lead federal agency with regard to 

allergens.’’ 

B. Letter From Public Health Advocates 

(2021 CSPI Letter) 

On February 24, 2021, a letter was 

submitted on behalf of CSPI, the 

Consumer Federation of America, the 

National Consumers League, Alcohol 

Justice, the American Institute for 

Cancer Research, Breast Cancer 

Prevention Partners, and the U.S. 

Alcohol Policy Alliance, urging the 

Secretary to adopt regulations to 

mandate alcohol content statements and 

a standardized Serving Facts label on all 

wine, distilled spirits, and malt 

beverage products regulated under the 

FAA Act. The letter also urged the 

adoption of regulations mandating an 

ingredient declaration that lists each 

ingredient by its common or usual name 

and identifies any major food allergens 

present in the product. 

C. Treasury Report on Competition in 

the Markets for Beer, Wine, and Spirits 

As noted above, on February 9, 2022, 

the Department of the Treasury, in 

consultation with the Department of 

Justice and the Federal Trade 

Commission, released a report on 

competition in the markets for alcohol 

beverages. One of the Competition 

Report’s findings was that ‘‘[r]egulatory 

proposals that could serve public health 

and foster competition by providing 

information to consumers, such as 

mandatory allergen, nutrition, and 

ingredient labeling proposals, have not 

been implemented.’’ 6 The Competition 

Report made some labeling 

recommendations, including a 

recommendation that TTB ‘‘should 

revive or initiate rulemaking proposing 

ingredient labeling and mandatory 

information on alcohol content, 

nutritional content, and appropriate 

serving sizes.’’ 7

D. 2024 Virtual Public Listening 

Sessions 

In light of the Competition Report, 

TTB announced in the Spring 2022 

Unified Agenda of Federal Regulatory 

and Deregulatory Actions that it would 

publish an NPRM on possible changes 

to its regulations related to allergen 

labeling for alcohol beverages. Executive 

Order 14094, ‘‘Modernizing Regulatory 

Review,’’ was subsequently published 

on April 6, 2023, directing agencies, to 

the extent practicable and consistent 

with applicable laws, to provide 

opportunities for public participation 

designed to promote equitable and 

meaningful participation by a range of 

interested or affected parties to inform 

regulatory actions. 

On January 31, 2024, TTB issued 

Notice No. 232, which announced two 

virtual listening sessions and the 

opening of a public docket to receive 

written comments on the labeling of 

alcohol beverages with per-serving 

alcohol and nutritional information, 

major food allergens, and/or ingredients. 

Consistent with Executive Order 14094, 

TTB sought input from a wide range of 

stakeholders, including those who may 

not usually comment on its proposals, 

to inform rulemaking, particularly given 

the broad implications of these issues. 

TTB also posed specific questions. 

Those related to major food allergens 

included whether consumers believe 

that they are adequately informed by 

information currently provided on 

alcohol beverage labels and whether 

listing major food allergens would be 

important information for consumers in 

making purchasing or consumption 

decisions. TTB also asked whether 

requiring additional information about 

major food allergens, alcohol or 

nutritional information, and ingredients 

on labels would be expected to increase 

the cost of products, and whether there 

are alternative ways of providing the 

information, for example by allowing 

information to be provided through a 

website using a quick response code 

(QR code) or website address on the 

label. 

The listening sessions, held on 

February 28 and 29, 2024, engaged 

consumers, public health stakeholders, 

and industry members representing 

businesses of different sizes. 

Approximately 700 registrants attended 

the two virtual sessions, including 47 

different speakers. In addition to the 

oral comments received during the 

listening sessions, TTB received 5,159 

written comments in response to Notice 

No. 232. 

The vast majority of the comments 

TTB received on allergens either favored 

mandatory labeling of major food 

allergens or did not express opposition 

to it. This included consumer and 

public health stakeholders as well as 

industry members and trade 

associations representing the alcohol 

beverage industry. However, some small 

sized producers opposed any new 

regulatory requirements. For example, 

Carriage House Vineyards and Travelers 

Cellar commented that ‘‘The proposed 

changes regarding nutritional 

information, major food allergens and 

ingredients would significantly and 

negatively impact our small farm 

winery. . . . In our years of operation, 

consumers have shown no interest, nor 

have to this point inquired on any of the 

items that the proposal is looking to 

add.’’ 

Consumers and public health 

stakeholders stated that major food 

allergen disclosures are necessary due to 

the implications for individuals with 


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5768 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

such allergies. TTB received 

substantially identical comments from 

4,724 individuals supporting allergen 

disclosures, as well as other disclosures 

for alcohol content, serving size, 

nutritional information, and ingredients, 

which stated that ‘‘For the 33 million 

Americans with food allergies, knowing 

what is in a product from ingredient and 

allergen labeling can be a matter of life 

or death.’’ Other individual commenters 

stressed the uncertainty they face 

without mandatory allergen disclosures. 

For example, one individual 

commented that ‘‘Without this 

information on alcoholic beverages, 

consuming them is like playing a 

lottery—I never know if a product may 

contain an ingredient I need to avoid 

until it’s too late.’’ The Centers for 

Disease Control and Prevention 

commented that ‘‘Accurate labeling for 

major food allergens is crucial 

information to ensure safety for the 

consumer.’’ AllergyStrong commented 

that ‘‘The majority of people are not 

aware alcohol falls outside [FALCPA]— 

mistakenly believing that any 

consumable product is accurately 

labeled for allergens.’’ CSPI stated that 

‘‘TTB should follow the lead of FDA 

and other countries and require 

ingredient and allergen labeling.’’ 

Some commenters expressed a 

preference that mandatory allergen 

labeling for alcohol beverages be 

consistent with FDA requirements. The 

Asthma and Allergy Foundation of 

America stated that ‘‘To the extent 

possible, labeling information should be 

displayed on alcoholic beverages similar 

to labeling on FDA-regulated foods. 

Consumers with food allergies are 

accustomed to FDA labeling, and would 

be able to easily transition to a similar 

model for checking the safety of 

alcoholic beverages . . .’’ The Brewers 

Association commented that ‘‘TTB 

should strive to make [major allergen] 

disclosures as consistent as possible 

with FDA disclosure rules under the 

FALCPA and its implementing 

regulations and guidance documents, 

while taking into account the different 

underlying labeling rules that apply to 

malt and other alcohol beverages versus 

most foods.’’ 

Other commenters discussed the 

effect of distillation on allergenic 

ingredients used in the production of 

alcohol beverages, suggesting that any 

mandatory allergen disclosures should 

be based on the product post-distillation 

rather than the raw materials prior to 

distillation. DISCUS stated that 

‘‘Scientifically-based major food 

allergen labeling . . . that properly 

identifies products containing allergenic 

protein capable of causing an adverse 

reaction—can provide beneficial 

information to consumers with 

allergies,’’ but also noted that 

distillation removes the proteins that 

cause allergic reactions and thus, ‘‘any 

new allergen labeling regulations need 

to be focused on the post distillation 

final product.’’ The Scotch Whisky 

Association commented that ‘‘The 

distillation process completely 

transforms the raw materials used to 

produce a distilled spirit, so they are 

undetectable in the final product. 

Therefore, distillers should only list the 

elements and ingredients that have been 

added to the final product. Otherwise, 

consumers could be misled into 

thinking that they would be affected by 

the properties of the raw material used 

in the distillation process.’’ 

Many of the comments TTB received 

from industry members and their trade 

associations advocated for the use of QR 

codes to satisfy new labeling 

requirements generally. However, 

among those who spoke about major 

food allergens specifically, some 

commenters otherwise in favor of QR 

codes still supported allergen 

declarations on the product’s label. The 

American Distilled Spirits Alliance 

(ADSA) commented that ‘‘while certain 

important information to consumers, 

including alcohol content and allergen 

information, may efficiently and 

effectively be included on a physical 

product label, more detailed 

information and information that is 

subject to periodic modification or 

update over time may be better 

communicated through a QR code. 

. . .’’ Similarly, the National 

Association of Beverage Importers 

commented that ‘‘The presence of a 

major allergen is also such an important 

piece of information’’ that it ‘‘must be 

available to all consumers and appear 

on a label on the bottle or container.’’ 

Comments from industry also noted 

concerns about costs associated with 

new labeling requirements generally, 

including costs to conduct laboratory 

testing. While commenters did not 

specifically refer to costs of laboratory 

analysis related to mandatory labeling of 

major food allergens, ADSA commented 

that ‘‘further discussion must be had 

around testing, requirements for good 

manufacturing practices and other 

safety protocols.’’ 

E. International Developments 

TTB participates in the Codex 

Alimentarius Commission by working 

with the FDA and the U.S. Codex Office 

at the U.S. Department of Agriculture. 

The Commission, which was 

established by the Food and Agriculture 

Organization and the World Health 

Organization, publishes the Codex 

Alimentarius, or ‘‘Food Code,’’ a 

collection of standards designed to 

protect the health of consumers and 

ensure fair practices in food trade. In 

recent years, the Codex Committee on 

Food Labelling has been discussing food 

allergen standards, allergen labeling 

provisions, and a possible framework 

for evaluating exemptions for food 

allergens. TTB is actively monitoring 

these developments and other Codex 

Alimentarius work related to alcohol 

labeling. 

V. Proposed Regulatory Changes 

For the reasons stated above, TTB is 

proposing rules for the mandatory 

labeling of major food allergens used in 

the production of alcohol beverages. 

Consistent with the FALCPA House 

committee report and TTB’s statutory 

mandate under the FAA Act to 

promulgate regulations ensuring that 

consumers receive adequate information 

about the identity and quality of alcohol 

beverages, TTB believes that alcohol 

beverage labels should provide 

consumers with sufficient information 

about the use of major food allergens in 

the production of alcohol beverages so 

that consumers with food allergies may 

make an informed decision as to 

whether consumption of a particular 

beverage may pose a risk of an allergic 

reaction. 

Existing regulations in 27 CFR 4.32, 

5.63, and 7.63 list the mandatory 

information that must appear on labels 

of wine, distilled spirits, and malt 

beverages, respectively. TTB proposes to 

amend these sections to include 

mandatory allergen labeling 

requirements, with a cross-reference to 

the proposed new regulations that 

provide more detail about the 

mandatory allergen labeling 

requirements. 

A. Labeling of Major Food Allergens and 

other Mandatory Disclosures 

1. Wording of the Labeling Statement 

and Other Mandatory Disclosures 

TTB is proposing that the mandatory 

food allergen statement consist of the 

words ‘‘Contains Major Food 

Allergen(s)’’ followed by a colon and the 

name of the food source(s) from which 

each major food allergen is derived, for 

example, ‘‘Contains Major Food 

Allergen: milk’’ or ‘‘Contains Major 

Food Allergens: wheat and milk.’’ This 

wording differs from the current 

voluntary allergen statement and is 

intended to make clear that the 

statement only relates to the nine major 


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8As noted previously, the FASTER Act of 2021 

revised 21 U.S.C. 321(gg) such that there are now 

nine major food allergens: milk, eggs, fish, 

Crustacean shellfish, tree nuts, wheat, peanuts, 

soybeans, and sesame. 

9 In a draft guidance published in April 2022, 

FDA notes the distinction between food allergies 

and other food intolerances, as well as the existence 

of more than 160 known food allergens, including 

the 9 currently identified major food allergens. See 

Evaluating the Public Health Importance of Food 

Allergens Other Than the Major Food Allergens 

Listed in the Federal Food, Drug, and Cosmetic Act: 

Guidance for FDA Staff and Stakeholders (Draft), 

available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/draftguidance-fda-staff-and-stakeholders-evaluatingpublic-health-importance-food-allergens-other. 

10 In the case of sulfites, the disclosure is required 

if the product contains ‘‘10 or more parts per 

million of sulfur dioxide or other sulfiting agent(s) 

measured as total sulfur dioxide.’’ 

11For example, ‘‘Contains Major Food Allergen: 

milk’’ or ‘‘Contains Major Food Allergens: egg and 

milk’’. 

food allergens 8 and does not include 

other, non-major food allergens, or other 

ingredients that may cause adverse 

reactions in some individuals.9 TTB 

specifically seeks comments below on 

this wording and other related issues as 

described in this section. 

TTB recognizes that changes in the 

wording or format of allergen 

disclosures may be warranted if TTB 

also requires ingredient disclosures. For 

example, if TTB requires both, aligning 

such labeling with food labeling may be 

warranted. Unlike foods labeled under 

FDA regulations, alcohol beverages 

subject to TTB’s labeling rules do not 

currently require the listing of 

ingredients on labels. TTB is conducting 

a separate rulemaking on this issue and 

is not proposing to adopt mandatory 

ingredient labeling in this document. 

For food products, FDA allows major 

food allergens to be listed within the 

ingredient statement by their common 

or usual name, or in a separate 

‘‘contains’’ statement. See 21 U.S.C. 

343(w)(1). If TTB adopts mandatory 

ingredient labeling, allowing a major 

food allergen disclosure within such a 

statement, or allowing the statement to 

simply say ‘‘contains’’ instead of 

‘‘Contains Major Food Allergen(s),’’ may 

be warranted. TTB seeks comment on 

these wording and format issues and the 

issues discussed below. 

Under current TTB regulations, 

certain ingredients that are not ‘‘major 

food allergens’’ but nevertheless pose a 

recognized public health problem must 

be disclosed on labels. Currently this 

includes FD&C Yellow No. 5, cochineal 

extract or carmine, sulfites, and 

aspartame.10 See 27 CFR 4.32, 5.63, and 

7.63. If an alcohol beverage contains any 

of the first four of these ingredients, the 

label must include a statement to that 

effect. While examples of such 

statements are provided, such as ‘‘FD&C 

Yellow No. 5’’ or ‘‘contains carmine,’’ 

the specific wording of the disclosure is 

left to the industry member. In the case 

of aspartame, the following statement, 

in capital letters, must appear, separate 

and apart from all other information: 

‘‘PHENYLKETONURICS: CONTAINS 

PHENYLALANINE.’’ Sometimes 

industry members combine such 

disclosures, along with voluntary 

disclosures of other ingredients, for 

example, ‘‘contains: cochineal extract 

and sulfites,’’ or ‘‘contains: sulfites and 

vanilla beans.’’ 

In this notice of proposed rulemaking, 

TTB is currently only proposing to 

change its regulations to require the 

mandatory major food allergen 

statement ‘‘Contains Major Food 

Allergen(s): . . .’’, which would be 

separate from and not affect other 

required disclosures.11 However, TTB 

solicits comments on the wording of the 

proposed mandatory major food allergen 

statement and the possible inclusion of 

other mandatory ingredient disclosures. 

Specifically, TTB solicits comments on 

the following: 

1. Should TTB adopt the proposed 

wording of the major food allergen 

statement (‘‘Contains major food 

allergen(s)’’ followed by a colon and the 

name of the food source from which 

each major food allergen is derived)? 

Alternately, should TTB require or 

allow alternative formats, including the 

following: 

• ‘‘Contains’’ followed by a colon and 

the name of the food source from which 

each major food allergen is derived; or 

• A heading such as ‘‘Major Food 

Allergen Information’’ followed by 

‘‘Contains:’’ or other language and the 

name of the food source from which 

each major food allergen is derived. 

2. Should TTB allow the inclusion of 

major food allergens within a voluntary 

ingredient statement on labels as an 

alternative to a separate major food 

allergen statement? 

3. If mandatory ingredient labeling is 

ultimately adopted, should TTB allow 

the inclusion of major food allergens in 

the list of ingredients as an alternative 

to a separate major food allergen 

statement? If mandatory ingredient 

labeling is ultimately adopted, should 

TTB use the ‘‘Contains’’ statement for 

major food allergens, consistent with 

FDA’s approach? Should TTB limit the 

use of the ‘‘Contains’’ statement only for 

major food allergens? 

4. Should other ingredients that are 

required to be disclosed under current 

TTB regulations (FD&C Yellow No. 5, 

cochineal extract or carmine, sulfites, 

and aspartame) be required to be listed 

in one statement on the label? If so, 

should the other ingredients be 

included in a ‘‘Contains’’ statement that 

includes the major food allergens? (For 

example, ‘‘Contains egg and sulfites’’). 

Or should the major food allergens be 

identified as such, and the other 

ingredients listed separately (for 

example, ‘‘Contains Major Food 

Allergen: egg. Contains sulfites’’)? 

Should another statement be used for 

ingredients that are required to be 

disclosed under current TTB regulations 

(FD&C Yellow No. 5, cochineal extract 

or carmine, sulfites, and aspartame) to 

differentiate from the ‘‘Contains’’ 

statement for major food allergens? 

5. Would requiring all mandatory 

disclosures to be in one place on the 

label, including the proposed major 

food allergen statement, make it easier 

for consumers to find this information? 

Would such a requirement impose 

additional costs or regulatory burdens 

on industry members as compared to 

allowing the mandatory disclosures to 

appear separately? 

6. Should TTB mandate specific 

placement, type size, and presentation 

requirements for major allergen labeling 

statements in addition to the 

requirements already applicable to all 

mandatory information on alcohol 

beverage labels? For example, should 

the required allergen disclosure 

statement be set off by a box? Or, to the 

extent practicable, should TTB mandate 

formatting consistent with FDA 

requirements for major allergen 

labeling? 

2. Definition of Major Food Allergen 

The definition of the term ‘‘major food 

allergen’’ is consistent with the statutory 

definition in the FD&C Act, as amended 

by FALCPA and the FASTER Act. TTB 

is proposing the same definition used by 

FALCPA, the FASTER Act, and FDA for 

consistency in labeling disclosures of 

major food allergens across products 

regulated by TTB and FDA. Thus, the 

proposed regulations define the term 

‘‘major food allergen’’ as 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, soybeans, and sesame.’’ The 

term as defined also includes any food 

ingredient that contains protein derived 

from one of these nine foods or food 

groups, subject to certain exceptions 

explained below in Section V.B. 

It should be noted that, consistent 

with guidance provided by FDA to the 

food industry, the proposed regulations 

allow the terms ‘‘soybean,’’ ‘‘soy,’’ and 

‘‘soya’’ as synonyms for the term 


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12See Questions and Answers Regarding Food 

Allergens, Including the Food Allergen Labeling 

Requirements of the Federal Food, Drug, and 

Cosmetic Act (Edition 5): Guidance for Industry 

(last revised, November 2022), page 9, available at 

https://www.fda.gov/media/117410/download. 

13See https://www.fda.gov/food/food-labelingnutrition/food-allergies. 

‘‘soybeans,’’ as used in the statute.12

Furthermore, consistent with FDA 

guidance, the singular term ‘‘peanut’’ 

may 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. 

FALCPA provides that in the case of 

tree nuts, the label must list the 

common name of the specific type of 

nut (for example, almonds, pecans, or 

walnuts), and in the case of Crustacean 

shellfish, the label must list the name of 

the species of shellfish (for example, 

crab, lobster, or shrimp). 21 U.S.C. 

343(w)(2). The proposed regulations are 

consistent with the FALCPA 

amendments with respect to the labeling 

of tree nuts and Crustacean shellfish. 

3. Labeling of Fish Species 

In the case of fish, the FALCPA 

amendments also provide that the name 

of the species of fish (for example, bass, 

flounder, or cod) must appear on the 

label. Id. However, for the reasons 

outlined below, the proposed 

regulations set forth in this document 

would not require labeling of the 

specific fish species. The proposed 

regulations would instead require 

simply listing ‘‘fish’’ when any type of 

finfish protein is used in the production 

of an alcohol beverage. 

Isinglass and fish gelatin are often 

used to clarify wines and beers. 

Isinglass is a substance obtained from 

the swim bladders of sturgeon and other 

fish. Fish gelatin is obtained from the 

skin of a fish. Fish gelatin is often made 

from cod skins but can be made from 

any species of fish. 

It is TTB’s understanding that 

vintners and brewers, when purchasing 

isinglass or fish gelatin from a 

manufacturer for fining purposes, often 

do not know, and have no way of easily 

finding out, which species of fish was 

used to make the product. Moreover, it 

may be difficult for industry members to 

determine by chemical analysis which 

fish species was the source of the 

isinglass or fish gelatin. 

TTB recognizes that the FALCPA 

amendments require the labeling of the 

species of fish used as an ingredient in 

a food product. However, it is TTB’s 

responsibility to implement allergen 

labeling regulations that are appropriate 

for alcohol beverages, as noted in the 

FALCPA House committee report. It is 

likely that declarations of the use of fish 

in the production of alcohol beverages 

will generally involve the use of 

isinglass or fish gelatin as a processing 

aid, rather than the use of fish or foods 

derived from fish as an ingredient or a 

flavor for an alcohol beverage, where the 

specific fish species may be more easily 

identified. Because of the particular 

difficulty faced by producers in 

determining the specific species of fish 

used in producing the isinglass or fish 

gelatin, and because at least some 

consumers may be allergic to more than 

one species of fish, requiring labeling 

with the name of the specific species of 

fish may impose a difficult fact-finding 

burden on the alcohol beverage industry 

without offering consumers significant 

additional information to help them 

avoid the risk of an allergic reaction. 

Accordingly, TTB solicits comments 

on whether labeling alcohol beverages 

produced using finfish protein merely 

as containing ‘‘fish,’’ rather than with 

the name of the fish species, provides 

adequate information to consumers. 

TTB also seeks comments on whether 

there are alternative approaches to this 

issue that would provide consumers 

with adequate information regarding the 

use of finfish protein in the production 

of alcohol beverages. 

4. Processing and Fining Agents 

Pursuant to the FD&C Act and its 

implementing regulations, incidental 

additives, including processing aids, are 

generally not subject to ingredient 

labeling requirements. FDA regulations 

exempt from the ingredient labeling 

requirements incidental additives that 

are present in a food at insignificant 

levels and do not have any technical or 

functional effect in that food. See 21 

CFR 101.100(a)(3). However, FALCPA 

amended the FD&C Act to require that, 

notwithstanding any other provision of 

law, a flavoring, coloring, or incidental 

additive that is, or that bears or 

contains, a major food allergen must 

conform to FALCPA’s labeling 

requirements. See 21 U.S.C. 343(w)(4). 

The TTB regulations on wine 

treatment, found at 27 CFR 24.246, 

authorize the use of certain materials 

that are approved as being consistent 

with good commercial practice in the 

production, cellar treatment, or 

finishing of wine and, where applicable, 

in the treatment of juice, subject to 

certain conditions. Some of these 

materials are processing aids derived 

from major food allergens. For example, 

albumen (egg white) is approved as a 

fining agent for wine, isinglass (a gelatin 

prepared from the swim bladders of 

fish) is approved to clarify wine, and 

casein (derived from milk) is approved 

to clarify wine. 

TTB is proposing to require the 

disclosure of fining or processing agents 

that are or contain major food allergens, 

with the option of including the added 

parenthetical ‘‘(processing aid)’’ and is 

soliciting comments on this proposal. 

For example, if egg whites are used as 

a processing aid for wine, the industry 

member has the option of disclosing this 

on the label as follows: ‘‘Contains Major 

Food Allergen: egg (processing aid).’’ 

This is an option that industry members 

may choose to use, but they also may 

choose to list these agents without the 

parenthetical. TTB is not proposing 

parenthetical statements for other 

incidental additives besides processing 

aids. TTB seeks comments on whether 

this proposal, which is generally 

consistent with FALCPA, will provide 

adequate information to consumers. 

TTB recognizes that some countries 

may handle this issue through 

exemptions for particular processing 

aids and that there are ongoing 

discussions about exemptions at the 

international level. TTB will monitor 

future developments to determine if 

they provide a scientifically supported 

basis for a more categorical exemption 

in this area, and we will continue to 

consult with FDA on this issue. 

5. Threshold Levels 

The FALCPA amendments, which 

took effect for foods labeled on or after 

January 1, 2006, require allergen 

labeling for packaged foods regulated by 

FDA without the establishment of any 

threshold levels for labeling. The FDA 

stated that a ‘‘threshold is a value below 

which it is unlikely that a food allergic 

individual would experience an adverse 

effect’’ and notes that ‘‘[a]t this time, the 

FDA has not established a threshold 

level for any allergens.’’ 13

Consistent with TTB’s longstanding 

policy of consulting with FDA in 

determining what ingredients in alcohol 

beverages should be disclosed on labels, 

TTB defers to FDA on this issue, and 

FDA has not established any thresholds 

for major food allergens. Accordingly, 

TTB is not proposing to set thresholds 

for the disclosure of major food 

allergens. Instead, the proposed rule 

provides that all major food allergens 

and proteins derived from the major 

food allergens used in production must 

be declared on the beverage label, 

unless the product or class of products 

is covered by an approved petition for 

exemption, or otherwise falls under an 

applicable exception, as discussed 

below. TTB believes that this position 

will ensure that consumers have 


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14TTB’s current position on gluten-free labeling 

of distilled foods is consistent with FDA’s. See 

https://www.ttb.gov/rulings/r2020-2. 

15Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ 

guidance-industry-food-allergen-labelingexemption-petitions-and-notifications. 

adequate information about the 

potential presence of major food 

allergens used in the production of 

alcohol beverages. If FDA establishes 

thresholds in the future, TTB will 

reconsider its policy on this issue. 

6. Allergen Advisory Labeling 

TTB’s proposal does not specifically 

address allergen advisory labeling, such 

as statements that a product may 

contain a major food allergen, e.g., ‘‘May 

Contain (major food allergen).’’ TTB is 

concerned that allergen advisory 

labeling could be used as substitute for 

adherence to current good 

manufacturing practices and could be 

misleading. TTB is soliciting comments 

on the use of allergen advisory labeling. 

B. Exceptions From Allergen Labeling 

Requirements 

1. Exceptions Found in Current 

Regulations 

TTB is not proposing to amend the 

standards set forth in the current 

regulations providing exceptions from 

major food allergen labeling for 

ingredients derived from highly refined 

oil (consistent with the definition of 

‘‘major food allergen’’ in the FD&C Act) 

and for food ingredients that are exempt 

pursuant to the FDA notice and petition 

processes in 21 U.S.C. 343(w)(6) or (7). 

Furthermore, TTB is not proposing to 

amend the current standards in the 

regulations that allow an exception for 

a product or class of products covered 

by a petition for exemption that is 

approved by TTB. A petition may 

pertain to the use of a major food 

allergen in the production of one 

specific alcohol beverage product or it 

may pertain to a class of products using 

a particular process involving a major 

food allergen. Consistent with the 1987 

MOU with FDA, TTB intends to confer 

with FDA, as appropriate and as FDA 

resources permit, on petitions submitted 

under the proposed rule. 

2. Distillation 

In previous rulemaking, commenters 

asked whether spirits distilled from a 

fermented mash containing a major food 

allergen (such as wheat) must be labeled 

as containing that major food allergen. 

Industry members have suggested that 

the distillation process removes all 

protein, including allergenic protein. 

TTB is therefore proposing in 27 CFR 

5.75(b)(2) that major food allergens, or 

ingredients containing major food 

allergens, need not be declared on a 

label when such allergens or ingredients 

have been subject to distillation in such 

a manner that no protein, allergenic or 

otherwise, remains in the distilled 

product or distilled ingredient. As 

explained below, this is consistent with 

the position FDA has taken regarding 

the removal of proteins using the 

distillation process within the context of 

major food allergen labeling and glutenfree labeling of distilled foods.14 TTB is 

soliciting comments on this proposal. 

In June 2015, FDA published Food 

Allergen Labeling Exemption Petitions 

and Notifications: Guidance for 

Industry.15 In that guidance, FDA 

provided general advice for when a 

petition or notification should be 

submitted under FALCPA, and 

specifically addressed the distillation 

process. In particular, the guidance 

stated that ‘‘An ingredient derived from 

a major food allergen that does not 

contain protein is not subject to the 

labeling requirements described in 

section 403(w)(1) of the FD&C Act.’’ 

FDA recognized that ‘‘there are some 

technologies (e.g., distillation) that may 

be able to produce protein-free 

ingredients because of the nature of the 

process and fundamental biochemical 

properties of proteins, peptides, and 

amino acids.’’ 

On August 13, 2020, FDA addressed 

the distillation issue in more detail in 

its final rule to establish compliance 

requirements for fermented and 

hydrolyzed foods, or foods that contain 

fermented or hydrolyzed ingredients, 

bearing a ‘‘gluten-free’’ claim. See ‘‘Food 

Labeling: Gluten-Free Labeling of 

Fermented or Hydrolyzed Foods’’ (85 FR 

49240). The preamble to the FDA final 

rule explained that ‘‘[i]f good 

manufacturing practices are followed, 

the process of distillation must remove 

all protein (and thus gluten), regardless 

if the product has been distilled from 

gluten-containing grains.’’ 85 FR 49248. 

FDA noted that ‘‘the process of 

distillation heats a liquid, which 

vaporizes components with lower 

boiling points and separates them from 

components with higher boiling points. 

The remaining compounds, whose 

boiling points are too high to undergo 

vaporization, are left behind.’’ Id. FDA 

concluded that ‘‘[i]f distillation is done 

properly, the process removes gluten 

because gluten does not vaporize.’’ Id. 

For this reason, FDA determined that ‘‘a 

distilled product’s labeling may bear a 

‘gluten-free’ claim and should be safe 

for people with celiac disease to 

consume.’’ Id. The final rule provides 

that when a scientifically valid method 

for verifying that a distilled product is 

gluten-free is not available, FDA will 

evaluate compliance ‘‘by verifying the 

absence of protein in the distilled 

component using scientifically valid 

analytical methods that can reliably 

detect the presence or absence of 

protein or protein fragments in the 

food.’’ 21 CFR 101.91(c)(5). The 

preamble to the FDA final rule noted 

that the ‘‘[t]ransfer of gluten into the 

distillate would only be expected to 

occur under poor manufacturing 

practices in which the initial material is 

splashing into the distillate due to poor 

design of the still. Protein testing can be 

done to confirm that protein (and thus 

gluten) is absent in the distilled 

product.’’ 85 FR 49248. FDA also noted 

that ‘‘any ingredients (such as flavors) 

added to the distilled product would 

need to be ‘gluten-free’ under 

§ 101.91(a)(3) for the finished product 

labeling to bear a gluten-free claim.’’ Id. 

Consistent with the FDA’s findings in 

its guidance on major food allergens and 

its final rule on the labeling of distilled 

food products with ‘‘gluten-free’’ claims, 

TTB is proposing to amend the distilled 

spirits regulations in proposed 27 CFR 

5.75(b)(2) to specifically provide that 

the mandatory labeling requirements do 

not apply to major food allergens used 

in the production of a distilled spirits 

product if they have been completely 

distilled in such a manner that no 

protein remains in the distilled spirits. 

As needed, TTB will evaluate 

compliance by verifying the absence of 

protein in the distilled component using 

scientifically valid analytical methods 

that can reliably detect the presence or 

absence of protein or protein fragments 

in the finished product. If ingredients 

containing protein are added to the 

distilled spirits product after 

distillation, and no major food allergens 

are listed on the label, industry 

members must be prepared to 

substantiate, upon request, the absence 

of protein in the distillate, the absence 

of any major food allergens in the added 

ingredients, and the precautions taken 

to prevent cross-contact. TTB is 

soliciting comments on whether this 

method of verifying compliance is 

adequate to protect consumers and 

whether there are better alternatives. 

C. Effective Date and Compliance With 

the Proposed Regulations 

TTB is proposing a compliance date 

of 5 years from the date that a final rule 

resulting from this proposal is 

published in the Federal Register to 

minimize the costs and burdens 

associated with the proposed new 

labeling information. TTB solicits 

comments on whether the proposed 


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16FDA has periodically contracted with RTI 

International to provide a model to estimate the 

costs of various product labeling changes required 

by regulation. The most recent version is the ‘‘2014 

FDA Labeling Cost Model, Final Report, August 

2015,’’ available at https://downloads.

regulations.gov/FDA-2016-N-2527-2681/ 

content.pdf. 

17Each individual product may have several 

UPCs associated with different sizes or types of 

packaging. 

18Based in part on data reported by NielsenIQ 

through its MarketTrack Service for the Alcohol 

Beverage Category for the period from September 9, 

2021 through September 10, 2022, for the Total US 

all outlets combined, liquor, and convenience stores 

market. Copyright © 2022 Nielsen Consumer LLC. 

19TTB emphasizes that the analyses, calculations 

and conclusions in this document may have been 

informed in part by the NielsenIQ RMS data 

through NielsenIQ’s Retail Measurement Service 

(RMS) for the beverage alcohol product categories 

for the reported time period for Total US expanded 

all outlets combined, liquor, and convenience 

stores. However, any such analyses, calculations 

and conclusions are those of TTB and do not reflect 

the views of NielsenIQ. NielsenIQ is not responsible 

for, had no role in, and was not involved in 

analyzing and preparing the results reported herein, 

or in developing, reviewing or confirming the 

research approaches used in connection with this 

document. 

20NielsenIQ’s xAOC market includes retailers in 

its Food, Drug, Mass, Walmart, Club, Dollar, and 

Military channels. Nielsen defines those channels 

as follows: 

—Food is inclusive of all grocery stores with 

greater than $2MM in annual ACV, including 

smaller chains and independents, and large players 

such as Whole Foods. 

—Drug is inclusive of all chains and 

independents with greater than $1MM in annual 

ACV. 

—Select Mass includes Target, K-Mart, and 

ShopKo. 

—Walmart includes Walmart Division 1 + 

Supercenter’s + Neighborhood Markets. 

—Select Club is inclusive of Sam’s Club and BJ’s. 

Costco does not participate in market measurement 

with any data provider. 

—Select Dollar is inclusive of Dollar General, 

Family Dollar, and Fred’s Dollar. 

—Military is inclusive of military commissary 

stores. 

21Nielsen states that its Convenience channel 

includes ‘‘major chains as census cooperators, and 

is projected to represent all chains and 

independents.’’ 

22The present discounted value of monetary 

values was calculated using a 2 percent discount 

rate in accordance with OMB Circular A–4 Chapter 

12, available at https://www.whitehouse.gov/wpcontent/uploads/2023/11/CircularA-4.pdf. 

23All costs in this proposal are provided in 2023 

dollars. 

compliance date would suffice to limit 

the impact on small businesses and to 

reduce overall costs of compliance 

while ensuring that consumers are 

adequately informed. TTB also seeks 

comments on whether the use of a 

single compliance date for any new 

regulations on allergen, ingredient, or 

‘‘Alcohol Facts’’ labeling would provide 

consumers with adequate information in 

a coherent and timely manner while 

also reducing costs and other regulatory 

burdens on industry. See Section VI, 

Cost Analysis, below, for additional 

information on coordinated labeling 

changes. Similarly, TTB intends to 

clarify that industry members will not 

be required to submit new COLA 

applications when the only change 

being made to a label is the inclusion of 

a statement of major food allergens. 

Therefore, this proposal would not 

require the submission of a new 

application for label approval simply to 

add allergen labeling statements in 

accordance with the new requirements. 

VI. Cost Analysis 

Executive Order 12866, as amended, 

requires TTB to design regulations in 

the most cost-effective manner that will 

achieve the regulatory objective. 

Accordingly, TTB seeks to tailor its 

regulations to impose the least burden 

on individuals, businesses of differing 

sizes, and other entities, consistent with 

the regulatory objective. 

A. TTB’s Estimate of Costs Associated 

With Alcohol Facts Proposed Rule 

In Notice No. 237, Alcohol Facts 

Statements in the Labeling of Wines, 

Distilled Spirits, and Malt Beverages, 

also published in this issue of the 

Federal Register, TTB proposed an 

amendment to the labeling regulations 

that would require an ‘‘Alcohol Facts’’ 

statement on each wine, distilled spirits, 

and malt beverage label subject to the 

FAA Act. TTB will not repeat the 

substance of that analysis here, but 

below is a summary of the findings of 

that analysis. 

To estimate the costs associated with 

the Alcohol Facts proposal, TTB 

utilized the 2014 FDA Labeling Cost 

Model,16 adding its own data inputs, 

making various assumptions about the 

alcohol beverage industry, and adjusting 

costs to reflect inflation through January 

2023. While FDA provided TTB with 

access to its model, FDA is not 

responsible for the assumptions made 

by TTB about the alcohol beverage 

market; nor is FDA responsible for the 

estimates set out in this analysis. 

To determine the number of alcohol 

beverage Universal Product Codes 

(UPCs) 17 in the marketplace, TTB 

contracted with NielsenIQ 18 to obtain a 

one-time report, which consists of data 

for the period from September 9, 2021, 

through September 10, 2022,19 for the 

following markets: Total U.S. all outlets 

combined,20 liquor, and convenience 

stores.21

Based on the available data, TTB 

estimated the one-time total labeling 

costs associated with the proposed rule 

on Alcohol Facts under a 2-year 

compliance period to have a present 

discounted value (PDV) 22 of 

approximately $323.4 million (or 

approximately $161.7 million per year). 

If the compliance date is extended to 3 

years, the total PDV would be 

approximately $258.5 million (or $86.5 

million per year); for 42 months, the 

total PDV would be approximately 

$204.3 million (or $58.4 million per 

year). Finally, if the compliance period 

is extended to 5 years, the total PDV 

would be approximately $201.2 million 

(or $40.2 million per year).23

B. Costs Associated With Allergen 

Proposed Rule if Coordinated With 

Alcohol Facts Proposal 

TTB is seeking comments on whether 

the compliance date for this proposed 

rule should be coordinated with the 

compliance dates of other labeling 

changes that have been proposed by 

TTB, including Notice No. 237, Alcohol 

Facts Statements in the Labeling of 

Wines, Distilled Spirits, and Malt 

Beverages, which proposed the 

inclusion of Alcohol Facts statements 

on alcohol beverage labels, as well as 

any proposals that may be aired as a 

result of the ANPRM on ingredient 

labeling. See Notice No. 237. 

Promulgating the requirements for the 

final label changes together would allow 

bottlers and importers to undertake all 

the label revisions necessary to 

implement these changes in one label 

change. For example, it is TTB’s 

preliminary conclusion that for industry 

members that would be required to 

make label changes under any new 

requirements resulting from the Alcohol 

Facts and the Allergen rulemakings, it 

would be more efficient and less costly 

to make changes to the label to 

accommodate both requirements at the 

same time. If the rules were instead 

promulgated and took effect at different 

points in time, TTB assumes that the 

multiple distinct label changes would 

result in greater costs. TTB invites 

comments on this preliminary 

conclusion. 

TTB estimates that the cost savings of 

a coordinated regulatory compliance 

date for the proposed labeling change 

rules would be significant. For the 

purposes of this economic analysis, TTB 

is considering major label changes to 

subsume minor label changes. For 

example, a UPC subject both to the 

Alcohol Facts NPRM that will affect 

virtually all UPCs (e.g., the addition of 

an Alcohol Facts statement), and the 

proposed Allergen rule would count 

only under the final Alcohol Facts rule 

because the major label change required 

by the proposed Alcohol Facts rule 

would subsume the minor label changes 


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24Further information on the specifics of TTB’s 

proposal and its authority to implement the 

proposal are in Section II. 

25See https://www.fda.gov/food/food-labelingnutrition/food-allergies. 

required by the proposed Allergen rule. 

The marginal additional cost of the 

Allergen rule above the cost of the 

proposed Alcohol Facts rule is, 

therefore, negligible if the two rules 

have the same compliance date. This 

cost savings arises because alcohol 

beverage bottlers and importers would 

generally have to make a major label 

change to comply with the Alcohol 

Facts rule, and industry members that 

were additionally affected by any new 

allergen disclosure requirements arising 

out of this rulemaking would be able to 

undertake just one label change to 

comply with the requirements of the 

two rules. 

VII. Public Participation 

A. Comments Sought 

TTB requests comments from the 

public and all interested parties on the 

regulatory proposals contained in this 

document. TTB seeks comments on the 

proposed rule as well as other 

approaches also discussed in this 

document. TTB has posed specific 

questions on various issues throughout 

this preamble and also seeks comments 

in response to those questions. In 

developing the final rule, TTB will 

carefully evaluate the proposed 

regulations considering all comments 

and suggested alternative approaches 

and will adopt the most appropriate 

approach. Where TTB has specifically 

solicited comments on alternatives to 

proposed amendments, it may consider 

adopting such alternatives in lieu of the 

proposed amendments based on its 

review of the comments. 

TTB also seeks comments on the 

impact that the proposed changes will 

have on consumers and on industry 

members and any suggestions as to how 

to minimize any costs or regulatory 

burdens associated with the proposed 

regulations, including the following 

issues: 

1. Are there alternative ways of 

providing a major food allergen 

disclosure, for example, by allowing 

information to be provided through a 

website using a quick response code 

(QR code) or website address on the 

label? Will such an alternative method 

still provide adequate information to the 

consumer? 

2. Does the proposed compliance date 

suffice to reduce overall costs of 

compliance, and specifically the costs to 

small businesses, while ensuring that 

consumers are protected? 

3. Is there a shorter compliance period 

that would provide more benefits to 

consumers while still limiting costs and 

potential impacts on small businesses? 

Specifically, would a 2-, 3-, or 3.5-year 

compliance period suffice? 

4. If a final rule is issued, will 

industry members begin 

implementation of the labeling changes 

in advance of the compliance date? If 

yes, how might consumers benefit from 

early compliance by industry? 

5. Are there any ongoing costs of 

compliance with the proposed rule that 

TTB has not addressed in this 

document? 

6. How many small businesses would 

be impacted by the proposed rule, and 

what would be the economic impact of 

the proposal on these small businesses? 

How, if at all, does the length of the 

compliance period affect the impact on 

small businesses? Please explain in 

detail and provide specific cost data. 

We welcome comments on all other 

issues presented in this document. 

B. Submitting Comments 

You may submit comments on this 

proposal as an individual or on behalf 

of a business or other organization via 

the Regulations.gov website or via 

postal mail, as described in the 

ADDRESSES section of this document. 

Your comment must reference Notice 

No. 238 and must be submitted or 

postmarked by the closing date shown 

in the DATES section of this document. 

You may upload or include attachments 

with your comment. You also may 

submit a comment requesting a public 

hearing on this proposal. The TTB 

Administrator reserves the right to 

determine whether to hold a public 

hearing. If TTB schedules a public 

hearing, it will publish a notice of the 

date, time, and place for the hearing in 

the Federal Register. 

C. Confidentiality and Disclosure of 

Comments 

All submitted comments and 

attachments are part of the rulemaking 

record and are subject to public 

disclosure. Do not enclose any material 

in your comments that you consider 

confidential or that is inappropriate for 

disclosure. 

TTB will post, and you may view, 

copies of this document, its supporting 

materials, and any comments TTB 

receives about this proposal within the 

related Regulations.gov docket. In 

general, TTB will post comments as 

submitted, and it will not redact any 

identifying or contact information from 

the body of a comment or attachment. 

Please contact TTB’s Regulations and 

Rulings Division by email using the web 

form available at https://www.ttb.gov/ 

contact-rrd, or by telephone at 202–453– 

2265, if you have any questions 

regarding comments on this proposal or 

to request copies of this document, its 

supporting materials, or the comments 

received in response. 

VIII. Regulatory Analysis and Notices 

The impacts of this proposed rule 

have been examined in accordance with 

Executive Order 12866, as 

supplemented by Executive Order 

13563 and amended by Executive Order 

14094, and the Regulatory Flexibility 

Act (5 U.S.C. 601–612). 

A. Purpose of the Rule 

The overall purpose of this proposed 

rule is to provide consumers who are 

allergic to one or more major food 

allergens with more information about 

the identity and quality of alcohol 

beverage products. Since the effective 

date of the Food Allergen Labeling and 

Consumer Protection Act of 2004 

(FALCPA), major food allergen labeling 

has been required for foods subject to 

the labeling regulations of the FDA 

(subject to certain exceptions), and the 

Department of Agriculture has similarly 

adopted regulations for foods subject to 

its labeling regulations. Alcohol 

beverages subject to the labeling 

regulations of the FAA Act are the only 

type of packaged beverage category 

without any requirement for major food 

allergen labeling. 

Accordingly, TTB proposes to require 

the disclosure of major food allergens 

used in the production of alcohol 

beverages subject to the FAA Act.24 TTB 

believes this proposal would provide 

consumers who are allergic to one or 

more of the nine major food allergens 

with the information they need to avoid 

exposure and the health risks posed by 

these ingredients. 

B. Benefits 

According to the FDA, food allergies 

and other food hypersensitivities affect 

millions of Americans.25 A food allergy 

is an immune response to certain 

proteins in food, which may cause mild 

symptoms, but may also result in a 

severe, life-threatening allergic reaction 

called anaphylaxis. Because food 

allergies currently cannot be cured, 

early recognition of which foods cause 

individuals to have an allergic reaction, 

and learning how to avoid such foods, 

are important ways to prevent serious 

health risks. 

TTB does not possess data that would 

enable it to quantify the monetary 

benefits of the proposed rule. However, 

TTB believes that a labeling statement 


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26Alcohol and Tobacco Tax and Trade Bureau 

Annual Report Fiscal Year 2022 (FY 2022 TTB 

Annual Report), available at https://www.ttb.gov/ 

images/pdfs/ttbar2022.pdf, page 5. 27 Id. at page 10. 28 Id. at page 16. It should be noted that the 

number of label applications does not necessarily 

correlate to the number of brands and UPCs in the 

marketplace for several reasons. TTB cannot 

determine whether approved labels appear in the 

marketplace, or how long those labels may remain 

in use. For example, there may be malt beverage 

labels authorized for a particular sporting event that 

are no longer found in the marketplace a few 

months after the event has taken place. On the other 

hand, some labels may be revised to reflect different 

net contents or alcohol content statements without 

submission of a new label to TTB. Industry 

members may decide not to use labels for which 

they have obtained approval. Thus, TTB does not 

use the number of COLA applications as an 

estimate of how many brands or UPCs are in the 

marketplace at any given time. 

29 Id. at page 30. 30Economic Contributions of Alcohol Beverage 

Industry 2019, Distilled Spirits Council of the 

United States, available at https://www.distilled

spirits.org/wp-content/uploads/2021/10/EconomicContributions-2019.pdf. See Annual Economic 

Briefing (February 9, 2023), Distilled Spirits 

Council of the United States, available at https://

www.distilledspirits.org/wp-content/uploads/2023/ 

02/FINAL-2022-AEB-Slide-Deck-2.9.23-941am.pdf. 

31See Size Standards, U.S. Small Business 

Administration, available at http://www.sba.gov/ 

content/small-business-size-standards. 

32 13 CFR 121.201. 

33 2019 SUSB Annual Data Tables by 

Establishment Industry, U.S. Census Bureau, 

available at https://www.census.gov/data/tables/ 

2019/econ/susb/2019-susb-annual.html. 

with information about the presence of 

major food allergens in the production 

of an alcohol beverage will provide 

significant benefits. Consumers with 

these food allergies will be able to make 

an informed decision as to whether 

consumption of a particular alcohol 

beverage may pose a risk of an allergic 

reaction. This proposal will also 

promote consistency in major food 

allergen disclosure across all types of 

food product labels, removing ambiguity 

about whether a product contains a 

major food allergen or not. TTB invites 

comments on its conclusion that 

consumers would benefit from having 

this information available on product 

labels. 

C. Costs of Compliance 

As set forth in Section VI of this 

preamble, based on its use of the FDA 

Labeling Cost Model and assuming a 5- 

year coordinated compliance period 

with the Alcohol Facts rule, TTB 

estimates that the marginal additional 

cost of the Allergen rule above the cost 

of the proposed Alcohol Facts rule is 

negligible. This is because industry 

members would generally have to make 

a major label change to comply with the 

Alcohol Facts rule, and industry 

members that were additionally affected 

by any new allergen labeling 

requirements from this rulemaking 

would be able to undertake just one 

label change to comply with the 

requirements of the two rules. 

TTB notes that this proposal does not 

require additional analytical testing, as 

it generally requires labeling of major 

food allergens used as an ingredient, 

and ingredients are expected to be 

known by the producer. 

D. Executive Orders 12866, 13563, and 

14094 

This proposed rule is a ‘‘significant 

regulatory action’’ for purposes of 

Executive Order 12866, as 

supplemented by Executive Order 

13563 and amended by Executive Order 

14094, and has been reviewed by the 

Office of Management and Budget. 

E. Regulatory Flexibility Act 

Pursuant to the requirements of the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), TTB has analyzed the 

potential economic effects of this action 

on small entities. In lieu of the initial 

regulatory flexibility analysis required 

to accompany proposed rules under 5 

U.S.C. 603, section 605 allows the head 

of an agency to certify that a rule will 

not, if promulgated, have a significant 

economic impact on a substantial 

number of small entities. 

TTB certifies that this proposed rule, 

if adopted, would not have a significant 

economic impact on a substantial 

number of small entities. The proposed 

rule will not impose, or otherwise 

cause, a significant increase in 

reporting, recordkeeping, or other 

compliance burdens on a substantial 

number of small entities. The proposed 

rule is not expected to have significant 

secondary or incidental effects on a 

substantial number of small entities. 

Accordingly, a regulatory flexibility 

analysis is not required. Pursuant to 26 

U.S.C. 7805(f), TTB will submit the 

proposed regulations to the Chief 

Counsel for Advocacy of the Small 

Business Administration (SBA) for 

comment on the impact of the proposed 

regulations on small businesses. 

The following analysis provides the 

factual basis for TTB’s certification 

under section 605. 

In FY 2022, TTB collected $8.3 billion 

in taxes from the alcohol industry.26

With regard to the total number of 

authorized producers of alcohol 

beverages, there are 17,649 wineries and 

bonded wine cellars; 14,185 brewers; 

and 4,494 distillers.27 However, the 

number of authorized producers and 

importers who obtain certificates of 

label approval (COLAs) in any given 

year, and who therefore could be 

affected by this proposed rule, is much 

lower. For example, in FY 2022, TTB 

received 192,954 label applications and 

26,922 formula applications for alcohol 

beverages.28 Internal data from TTB’s 

COLAs Online system shows that, on 

average, fewer than 12,000 permittees or 

brewers applied for label approval in 

each of Fiscal Years 2020–2022. The 

data also shows that most of these 

COLA applications come from the same 

set of permittees and brewers every 

year. During the 3-year period of Fiscal 

Years 2020–2022, fewer than 18,000 

unique permittees or brewers applied 

for label approval. 

The value of the U.S. import trade in 

alcohol beverages in 2021 totaled $23.9 

billion.29 According to data published 

on the website of the Distilled Spirits 

Council of the United States,30 the total 

economic contribution of the alcohol 

beverage industry to the U.S. economy 

in 2019 included 2,514,000 ‘‘direct’’ 

jobs and 5,630,000 ‘‘total’’ jobs; $67.9 

billion in direct wages and $160.3 

billion in total wages; and $242.6 billion 

in direct economic activity and $572.3 

billion in total economic activity. 

TTB recognizes that most producers, 

bottlers, and importers of alcohol 

beverages are small entities. The SBA 

sets out size standards based on the 

North American Industry Classification 

System (NAICS), under which an entity 

can be considered small for the 

purposes of Regulatory Flexibility Act 

analysis.31 Breweries are considered 

small if they have fewer than 1,250 

employees; wineries are considered 

small if they have fewer than 1,000 

employees; and distilleries are 

considered small if they have fewer than 

1,100 employees.32

The U.S. Census Bureau’s Statistics of 

U.S. Businesses (SUSB) data include 

information on employment among 

establishments within NAICS codes. 

The most recent data are from 2019.33

The SUSB data did not include 

employment at the 1,000, 1,100, or 

1,250 employee threshold; however, it 

does include the number of firms within 

each NAICS code that have at least 500 

employees. Based on those numbers, 

approximately 99% of the firms in these 

three NAICS codes are small entities. 

The percentage may be greater, 

depending on how many firms have at 

least 500 employees and fewer than 

1,000 employees (for wineries), 1,100 

employees (for distilleries), or 1,250 

employees (for breweries). There is no 

NAICS code for importers of alcohol 

beverages. 


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34This data is only available from Economic 

Census years (years ending in 2 and 7). See 2017 

SUSB Annual Data Tables by Establishment 

Industry, U.S. Census Bureau, available at https:// 

www.census.gov/data/tables/2017/econ/susb/2017- 

susb-annual.html. 

35A recent study estimates that 28.3% of brewing 

facilities are brewpubs, with 66.7% of brewing 

facilities categorized as ‘‘micro’’ breweries. The 

study explains that brewpubs and small microbrewers ‘‘produce beer for a limited market— 

sometimes only for their own restaurant or retail 

establishment.’’ See Beer Serves America—A Study 

of the U.S. Beer Industry’s Economic Contribution 

in 2022,’’ prepared for the Beer Institute and 

National Beer Wholesalers Association, which is 

available at https://beerservesamerica.org/wpcontent/uploads/2023/05/2022-Beer-ServesAmerica-Report.pdf. 

TABLE 1—NUMBER OF FIRMS WITH AT LEAST 500 EMPLOYEES

Small-entity size standards for potentially affected industries and number of firms with at least 500 employees 

Total 

Industry employment 

(NAICS code) Small-entity size standard Total number of firms 

Number of firms with at least 500 

employees 

Breweries (NAICS 312120) ............ Fewer than 1,250 employees ........ 4,217 23 (approximately 0.5 percent) ...... 84,503 

Wineries (NAICS 312130) .............. Fewer than 1,000 employees ........ 3,944 19 (approximately 0.48 percent) .... 59,587 

Distilleries (NAICS 312140) ............ Fewer than 1,100 employees ........ 1,004 10 (approximately 1%) ................... 16,828 

Data on revenues by firm size and 

industry are also available in the SUSB, 

but are published less frequently. The 

most recent data available is from 

2017.34 Based on this data, with the 

revenues adjusted for inflation, 2,609 of 

the total number of firms (3,214) listed 

as breweries under NAICS Code 312120 

have fewer than 20 employees.35 This 

category accounts for $3,314,362,000 of 

the total inflation-adjusted receipts of 

$36,032,713,000, or roughly 9.2 percent 

of the total receipts. With regard to 

wineries, 2,975 of the 3,576 firms under 

NAICS Code 31230 have fewer than 20 

employees. This category accounts for 

$2,907,606,000 of the total inflationadjusted receipts of $24,891,833,000, or 

roughly 12 percent of the total receipts. 

With regard to distilleries, 659 of the 

760 firms under NAICS Code 31240 

have fewer than 20 employees. This 

category accounts for $1,060,898,000 of 

the total inflation-adjusted receipts of 

$14,590,615,000 or roughly 7 percent of 

the total receipts. 

As noted above, not all alcohol 

beverage producers would be impacted 

by the requirements of this proposed 

rule. Some alcohol beverages, while 

subject to permitting and excise tax 

requirements, are not required to be 

labeled under the FAA Act. These 

include wines with less than 7 percent 

alcohol by volume and beer produced 

without both malted barley and hops. 

Additionally, most alcohol beverages do 

not contain major food allergens. Some 

examples of alcohol beverages that use 

ingredients in the production process 

that contain major food allergens are 

malt beverages that contain wheat, and 

wines and malt beverages that use eggs 

or fish as processing aids. Some 

specialty products that are currently 

labeled as containing ‘‘natural flavors’’ 

may also have to include new labels 

disclosing the use of major food 

allergens. 

While most businesses subject to the 

proposed rule are small businesses, the 

changes proposed in this document will 

not have a significant impact on those 

small entities. The production, bottling, 

importation, and distribution of alcohol 

beverages is an industry subject to 

extensive Federal, State, and local 

regulation. The labeling and advertising 

regulations under the FAA Act have 

been in place since 1936. TTB believes 

that adding a disclosure requirement for 

major food allergens, the presence of 

which industry members already track 

in the usual course of business, will not 

have a significant impact on the 

regulated industry. 

TTB cannot estimate the exact cost 

per small entity because we do not 

know how many product brands 

(covered by different UPCs) on average 

are owned by small entities as defined 

by the SBA. However, as discussed in 

Section VI, above, TTB estimates that 

the marginal additional cost of the 

Allergen rule above the cost of the 

proposed Alcohol Facts rule is 

negligible. This is because industry 

members would generally have to make 

a major label change to comply with the 

Alcohol Facts rule, and industry 

members that were additionally affected 

by any new allergen labeling 

requirements from this rulemaking 

would be able to undertake just one 

label change to comply with the 

requirements of the two rules. 

This proposal differs from the 

proposed rule on mandatory allergen 

statements in 2006 in that allergen 

labeling requirements will not apply to 

distilled spirits products where no 

protein from major food allergens 

remains in the product after distillation. 

See Section V, above, and Notice No. 62, 

71 FR 42329, July 26, 2006. This will 

reduce the number of products subject 

to major allergen disclosure, and thus 

the compliance burden for small 

distillers. Additionally, TTB is 

proposing to reduce the costs associated 

with the label redesign by not requiring 

industry members to submit new 

applications for label approval when the 

only change is the inclusion, deletion, 

or revision of a major food allergen 

statement. 

TTB considered other options to 

reduce the regulatory burden and cost 

for small businesses, but ultimately is 

not proposing them. One option 

considered was to exempt small 

businesses from the requirements of the 

proposed rule. The primary purpose of 

this proposed rule is to provide 

information to consumers who are 

allergic to one or more of the nine major 

food allergens. This purpose would be 

weakened by a permanent exemption 

for small businesses. Consumers would 

not be able to rely on alcohol beverage 

labels to disclose the presence of major 

food allergens if the requirements did 

not apply to all such products. 

Moreover, TTB questions whether a 

permanent exemption from mandatory 

labeling requirements would be 

consistent with the mandate, in the FAA 

Act, to ensure that labels provide 

consumers with adequate information 

about the identity and quality of alcohol 

beverage products. TTB notes that there 

is no specific statutory authority for 

exempting small businesses from the 

requirements of the FAA Act as there is 

under the FD&C Act for nutritional 

labeling regulated by the FDA. Further, 

the small business exemption under 

FDA regulations pertains only to 

nutrition labeling information, and not 

to any other mandatory information, 

including allergens. TTB also 

considered the option of proposing an 

extended compliance period only for 

small businesses. However, this would 

not be administrable for TTB without 

imposing additional requirements on 

these businesses. When reviewing 

applications for label approval, TTB 

employees do not have access to the 

number of people employed by each 

company, and thus it would not be 

practical to base compliance status on 

the SBA standards for small businesses. 

Additionally, reporting such 

information to TTB with each label 


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5776 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

application would impose a new burden 

on all industry members that would be 

subject to this proposed rule. Instead, 

TTB is proposing a compliance period 

of 5 years for all industry members, and 

is expecting that many industry 

members, particularly large businesses, 

will start declaring major food allergens 

after publication of a final rule, in 

advance of the compliance date. 

As previously noted, the label 

redesign, printing, and administrative 

costs associated with making a labeling 

change are on a per-UPC basis. Under 

the FDA Labeling Cost Model, the 

longer the compliance period, the more 

likely it is that affected industry 

members can coordinate new labeling 

requirements with scheduled labeling 

changes, so cost estimates fall 

significantly as the time allowed for the 

new labeling requirements increases. In 

other words, the longer the period 

industry is given to comply with the 

new labeling requirements, the lower 

the costs. According to the FDA 

Labeling Cost Model, with a compliance 

period of 5 years, 100 percent of the 

labeling changes resulting from a 

regulatory change can be coordinated 

with a regularly scheduled labeling 

change, thus significantly reducing the 

estimated costs and burdens for small 

businesses that would be subject to the 

proposed rule. 

TTB specifically solicits comments on 

the number of small producers, bottlers, 

and importers of alcohol beverages that 

may be affected by this proposed rule 

and the impact of this rule on those 

small businesses. TTB welcomes data 

on all these issues. 

F. Paperwork Reduction Act 

Three of the regulatory sections 

addressed in this notice of proposed 

rulemaking contain collections of 

information that have been previously 

reviewed and approved by the Office of 

Management and Budget (OMB) in 

accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

Those regulatory sections are 27 CFR 

4.32, 5.63, and 7.63, and they contain 

existing information collections 

assigned OMB control numbers 1513– 

0084 and 1513–0087. OMB No. 1513– 

0084 concerns the labeling of sulfites in 

alcohol beverages, and OMB No. 1513– 

0087 concerns alcohol beverage labeling 

requirements under the FAA Act. 

This proposed rule includes a new 

collection of information involving the 

mandatory declaration of major food 

allergens on the labels of alcohol 

beverages. This collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and approval under 

the Paperwork Reduction Act of 1995 

pending receipt and evaluation of 

public comments. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a valid 

control number assigned by OMB. 

The regulatory sections in this 

proposed rule that contain the new 

information collection requirement for a 

declaration of major food allergens are 

in proposed regulatory sections §§ 4.32 

and 4.32a for wine labels, §§ 5.63 and 

5.75 for distilled spirits labels, and 

§§ 7.63 and 7.75 for malt beverage 

labels. This new collection of 

information will be mandatory, and the 

likely respondents are for-profit 

businesses, including corporations, 

partnerships, and small businesses. 

Specifically, the new information 

collection would require alcohol 

beverage bottlers and importers to 

disclose the presence of any of the nine 

major food allergens (milk, eggs, fish, 

Crustacean shellfish, tree nuts, wheat, 

peanuts, soybeans, and sesame), as well 

as ingredients that contain protein 

derived from these foods, if used in the 

production of the alcohol beverage, 

unless an exception applies. The 

disclosure would state ‘‘Contains major 

food allergen(s)’’ followed by a colon 

and the name of the food source from 

which each major food allergen is 

derived. 

As discussed in Section VI, Cost 

Analysis, above, the FDA Labeling Cost 

Model projects a ‘‘mean’’ internal 

recordkeeping burden of 1 hour per UPC 

for labeling changes that are 

coordinated, and 2 hours per UPC for 

labeling changes that are not 

coordinated. As noted above, TTB is 

proposing a 5-year compliance date, 

which means that 100 percent of the 

labeling changes will be ‘‘coordinated.’’ 

TTB believes that a significant 

proportion of the alcohol beverage 

industry already collects and maintains 

information regarding the presence of 

major food allergens in their products in 

the usual course of business. 

Furthermore, TTB does not propose to 

require industry members to submit 

new COLA applications for the sole 

purpose of adding, deleting, or revising 

major food allergen statements. Thus, 

the proposed rule would not increase 

recordkeeping requirements regarding 

certificates of label approval, which are 

covered by OMB Control Number 1513– 

0020. 

Accordingly, TTB is estimating an 

annual burden of 1 hour per respondent 

for the new major food allergen 

disclosures proposed under the FAA 

Act labeling regulations. TTB estimates 

its annual burden as follows: 

• Number of Respondents: 10,000. 

• Number of Responses: 30,000. 

• Average per-Response Burden: 1 

hour per respondent. 

• Total Annual Burden: 10,000 hours. 

TTB has submitted the major allergen 

disclosure statement information 

collection requirements and the revised 

collection requirements under the FAA 

Act to OMB for review. Please send any 

comments on these new and revised 

collection requirements to OMB at 

Office of Management and Budget, 

Attention: Desk Officer for the 

Department of the Treasury, Office of 

Information and Regulatory Affairs, 

Washington, DC 20503, or by email to 

OIRA_submissions@omb.eop.gov. Please 

also send a copy of any such comments 

to TTB by any of the comment 

submission methods described in the 

ADDRESSES section of this document. 

Comments should be submitted no later 

than April 17, 2025. 

TTB specifically requests comments 

concerning: 

• The accuracy of the estimated 

burden associated with the proposed 

collections of information (see below); 

• Whether a unified compliance date 

for labeling changes that may arise from 

this rulemaking, along with separate 

rulemakings on ingredient labeling and 

‘‘Alcohol Facts’’ labeling, would result 

in lowering the combined burden hours 

for the three rulemakings; 

• Whether the proposed labeling 

requirements are necessary to provide 

consumers with adequate information as 

to the identity and quality of alcohol 

beverages, including whether the 

information will have practical utility; 

• How to enhance the quality, utility, 

and clarity of the information to be 

collected; 

• How to minimize the burden of 

complying with the collections of 

information; and; 

• Estimates of capital and start-up 

costs and costs of operation, 

maintenance, and purchase of services 

to maintain records and substantiate 

label claims. 

List of Subjects 

27 CFR Part 4 

Advertising, Alcohol and alcoholic 

beverages, Customs duties and 

inspection, Imports, Labeling, Packaging 

and containers, Reporting and 

recordkeeping requirements, Surety 

bonds, Trade practices, Treaties, Wine. 

27 CFR Part 5 

Advertising, Alcohol and alcoholic 

beverages, Customs duties and 

inspection, Distilled spirits, Food 

additives, Grains, Imports, International 


KHAMMOND on DSK9W7S144PROD with PROPOSALS
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 5777 

agreements, Labeling, Liquors, 

Packaging and containers, Reporting 

and recordkeeping requirements, Trade 

practices. 

27 CFR Part 7 

Advertising, Alcohol and alcoholic 

beverages, Beer, Customs duties and 

inspection, Food additives, Imports, 

Labeling, Malt Beverages, Packaging and 

containers, Reporting and recordkeeping 

requirements, Trade practices. 

Amendments to the Regulations 

For the reasons discussed in the 

preamble, TTB proposes to amend 27 

CFR parts 4, 5, and 7 as set forth below: 

PART 4—LABELING AND 

ADVERTISING OF WINE 

■ 1. The authority citation for 27 CFR 

part 4 continues to read as follows: 

Authority: 27 U.S.C. 205, unless otherwise 

noted. 

■ 2. Amend § 4.32 by adding paragraph 

(f) to read as follows: 

§ 4.32 Mandatory label information. 

* * * * * 

(f) Declaration of major food 

allergens. If any major food allergen as 

defined in § 4.32a is used in the 

production of a wine, the label must 

include a statement as required by that 

section. 

* * * * * 

■ 3. Amend § 4.32a by revising the 

section heading and paragraphs (a)(1)(i), 

(b), and (c) to read as follows: 

§ 4.32a Mandatory labeling of major food 

allergens. 

(a) * * * 

(1) * * * 

(i) 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, soybeans, 

and sesame; or 

* * * * * 

(b) Labeling requirements. All major 

food allergens (defined in paragraph 

(a)(1) of this section) used in the 

production of a wine, including major 

food allergens used as incidental 

additives, such as processing aids, must 

be declared on a label affixed to the 

container, except when covered by a 

petition for exemption approved by the 

appropriate TTB officer under § 4.32b. 

The declaration must consist of the 

words ‘‘Contains Major Food 

Allergen(s)’’ followed by a colon and the 

name of the food source from which 

each major food allergen is derived (for 

example, ‘‘Contains Major Food 

Allergen: milk’’ or ‘‘Contains Major 

Food Allergens: egg and milk’’), except 

that the declaration of processing aids 

(such as clarifying agents) may 

optionally include the parenthetical 

explanation (‘‘processing aid’’) 

immediately following the name of the 

major food allergen (for example, 

‘‘Contains Major Food Allergen: egg 

(processing aid).’’ 

(c) Cross reference. For labeling 

requirements applicable to wines 

containing FD&C Yellow No. 5, 

cochineal extract or carmine, and 

sulfites, see § 4.32(c) through (e). 

PART 5—LABELING AND 

ADVERTISING OF DISTILLED SPIRITS 

■ 4. The authority citation for 27 CFR 

part 5 continues to read as follows: 

Authority: 26 U.S.C. 5301, 7805, 27 U.S.C. 

205 and 207. 

■ 5. Amend § 5.63 by redesignating 

paragraphs (c)(5) through (8) as 

paragraphs (c)(6) through (9) and adding 

a new paragraph (c)(5). 

The addition reads as follows: 

§ 5.63 Mandatory label information. 

* * * * * 

(c) * * * 

(5) Major food allergens. If any major 

food allergen as defined in § 5.75 is used 

in the production of a distilled spirits 

product, the label must include a 

statement as required by that section. 

* * * * * 

Subpart F—[Amended] 

■ 6. Amend subpart F by removing the 

undesignated center heading ‘‘Food 

Allergen Labeling’’ preceding § 5.82. 

§§ 5.82 and 5.83 [Redesignated as §§ 5.75 

and 5.76] 

■ 7. Redesignate §§ 5.82 and 5.83 as 

§§ 5.75 and 5.76, respectively, in 

subpart F. 

■ 8. Amend newly redesignated § 5.75 

by revising the section heading and 

paragraphs (a)(1)(i) and (b) and adding 

paragraph (c) to read as follows: 

§ 5.75 Mandatory labeling of major food 

allergens. 

(a) * * * 

(1) * * * 

(i) 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, soybeans, 

and sesame; or 

* * * * * 

(b) Labeling requirements. (1) Except 

as provided in paragraph (b)(2) of this 

section, all major food allergens 

(defined in paragraph (a)(1) of this 

section) used in the production of a 

distilled spirits product, including 

major food allergens used as incidental 

additives, such as processing aids, must 

be declared on a label affixed to the 

container, except when covered by a 

petition for exemption approved by the 

appropriate TTB officer as described in 

§ 5.76. The declaration must consist of 

the words ‘‘Contains Major Food 

Allergen(s)’’ followed by a colon and the 

name of the food source from which 

each major food allergen is derived (for 

example, ‘‘Contains Major Food 

Allergen: milk’’ or ‘‘Contains Major 

Food Allergens: wheat and milk’’), 

except that the declaration of processing 

aids (such as clarifying agents) may 

optionally include the parenthetical 

explanation (‘‘processing aid’’) 

immediately following the name of the 

major food allergen (for example, 

‘‘Contains Major Food Allergen: egg 

(processing aid).’’ 

(2) The labeling requirements of this 

section do not apply to major food 

allergens used in the production of a 

distilled spirits product if they have 

been completely distilled in such a 

manner that no protein remains in the 

distilled spirits. TTB will evaluate 

compliance by verifying the absence of 

protein in the distilled component using 

scientifically valid analytical methods 

that can reliably detect the presence or 

absence of protein or protein fragments 

in the finished product. If ingredients 

containing protein are added to the 

distilled spirits product after 

distillation, and no major food allergens 

are listed on the label, industry 

members must be prepared to 

substantiate, upon request, the absence 

of protein in the distillate, the absence 

of any major food allergens in the added 

ingredients, and the precautions taken 

to prevent cross-contact. 

(c) Cross reference. For labeling 

requirements applicable to distilled 

spirits containing FD&C Yellow No. 5, 

cochineal extract or carmine, sulfites, 

and aspartame, see § 5.63(c)(6) through 

(9). 

§ 5.76 [Amended] 

■ 9. Amend newly redesignated § 5.76 

in paragraph (a) introductory text by 

removing ‘‘5.82’’ and adding in its place 

‘‘5.75’’ and in paragraph (a)(2) by 

removing ‘‘5.82(a)(1)(i)’’ and adding in 

its place ‘‘5.75(a)(1)(i)’’. 

§§ 5.82 and 5.83 [Reserved] 

■ 10. Add reserved §§ 5.82 and 5.83. 

PART 7—LABELING AND 

ADVERTISING OF MALT BEVERAGES 

■ 11. The authority citation for 27 CFR 

part 7 continues to read as follows: 


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5778 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

Authority: 27 U.S.C. 205 and 207. 

Subpart E—Mandatory Label 

Information 

■ 12. Amend § 7.63 by adding paragraph 

(b)(5) to read as follows 

§ 7.63 Mandatory label information. 

* * * * * 

(b) * * * 

(5) Major food allergens. If any major 

food allergen as defined in § 7.75 is used 

in the production of a malt beverage, the 

label must include a statement as 

required by that section. 

§§ 7.71 through 7.74 [Reserved] 

■ 13. Add reserved §§ 7.71 through 7.74. 

Subpart F—[Amended] 

■ 14. Amend subpart F by removing the 

undesignated center heading ‘‘Food 

Allergen Labeling’’ preceding § 7.82. 

§§ 7.82 and 7.83 [Redesignated as §§ 7.75 

and 7.76] 

■ 15. Redesignate §§ 7.82 and 7.83 as 

§§ 7.75 and 7.76, respectively, in 

subpart F. 

■ 16. Amend newly redesignated § 7.75 

by revising the section heading and 

paragraphs (a)(1)(i), (b), and (c) to read 

as follows: 

§ 7.75 Mandatory labeling of major food 

allergens. 

(a) * * * 

(1) * * * 

(i) 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, soybeans, 

and sesame; or 

* * * * * 

(b) Labeling requirements. All major 

food allergens (defined in paragraph 

(a)(1) of this section) used in the 

production of a malt beverage, including 

major food allergens used as incidental 

additives, such as processing aids, must 

be declared on a label affixed to the 

container, except when covered by a 

petition for exemption approved by the 

appropriate TTB officer under § 7.76. 

The declaration must consist of the 

words ‘‘Contains Major Food 

Allergen(s)’’ followed by a colon and the 

name of the food source from which 

each major food allergen is derived (for 

example, ‘‘Contains Major Food 

Allergen: milk’’ or ‘‘Contains Major 

Food Allergens: wheat and milk’’), 

except that the declaration of processing 

aids (such as clarifying agents) may 

optionally include the parenthetical 

explanation (‘‘processing aid’’) 

immediately following the name of the 

major food allergen (for example, 

‘‘Contains Major Food Allergen: egg 

(processing aid).’’ 

(c) Cross reference. For labeling 

requirements applicable to malt 

beverages containing FD&C Yellow No. 

5, cochineal extract or carmine, sulfites, 

and aspartame, see § 7.63(b)(1) through 

(4). 

§ 7.76 [Amended] 

■ 17. Amend newly redesignated § 7.76 

in paragraph (a) introductory text by 

removing ‘‘7.82’’ and adding in its place 

‘‘7.75’’ and in paragraph (a)(2) by 

removing ‘‘7.82(a)(1)(i)’’ and adding in 

its place ‘‘7.75(a)(1)(i)’’. 

§§ 7.82 and 7.83 [Reserved] 

■ 18. Add reserved §§ 7.82 and 7.83. 

Signed: January 10, 2025. 

Mary G. Ryan, 

Administrator. 

Approved: January 10, 2025. 

Aviva Aron-Dine, 

Deputy Assistant Secretary (Tax Policy). 

[FR Doc. 2025–00955 Filed 1–16–25; 8:45 am] 

BILLING CODE 4810–31–P 

DEPARTMENT OF EDUCATION 

34 CFR Chapter III 

[Docket ID ED–2025–OSERS–0003] 

Rehabilitation Training Program— 

National Vocational Rehabilitation 

Technical Assistance Center 

AGENCY: Office of Special Education and 

Rehabilitative Services (OSERS), 

Department of Education. 

ACTION: Proposed priority, requirements, 

and definitions. 

SUMMARY: The Assistant Secretary for 

Special Education and Rehabilitative 

Services proposes a priority, 

requirements, and definitions under the 

Rehabilitation Training program. The 

Assistant Secretary may use the priority, 

requirements, and definitions for 

competitions in fiscal year (FY) 2025 

and later years. We intend to use the 

priority, requirements, and definitions 

to fund a cooperative agreement to 

establish a national vocational 

rehabilitation technical assistance 

center (NVRTAC) to provide training 

and technical assistance to personnel of 

State VR agencies and their partners to 

upgrade and increase their 

competencies, skills, and knowledge in 

providing quality services and effective 

management of the VR program. 

DATES: We must receive your comments 

on or before February 18, 2025. 

ADDRESSES: Comments must be 

submitted via the Federal eRulemaking 

Portal at www.regulations.gov. However, 

if you require an accommodation or 

cannot otherwise submit your 

comments via www.regulations.gov, 

please contact the program contact 

person listed under FOR FURTHER

INFORMATION CONTACT. The Department 

will not accept comments submitted by 

fax or by email or those submitted after 

the comment period. To ensure that we 

do not receive duplicate copies, please 

submit your comments only once. In 

addition, please include the Docket ID 

at the top of your comments. 

Federal eRulemaking Portal: Go to 

www.regulations.gov to submit your 

comments electronically. Information 

on using Regulations.gov, including 

instructions for accessing agency 

documents, submitting comments, and 

viewing the docket, is available on the 

site under ‘‘FAQ.’’ 

Privacy Note: The Department’s 

policy is to make all comments received 

from members of the public available for 

public viewing in their entirety on the 

Federal eRulemaking Portal at 

www.regulations.gov. Therefore, 

commenters should be careful to 

include in their comments only 

information they wish to make publicly 

available. 

FOR FURTHER INFORMATION CONTACT: 

Roslyn Thomas, U.S. Department of 

Education, 400 Maryland Avenue SW, 

Lyndon Baines Johnson Building, Room 

4A10, Washington, DC 20202. 

Telephone: (202) 987–0105. Email: 

84.264L@ed.gov. 

If you are deaf, hard of hearing, or 

have a speech disability and wish to 

access telecommunications relay 

services, please dial 7–1–1. 

A brief summary of the rule is 

available at www.regulations.gov/ 

docket/ED-2025-OSERS-0003. 

SUPPLEMENTARY INFORMATION: 

Invitation to Comment: We invite you 

to submit comments regarding the 

proposed priority, requirements, and 

definitions. To ensure that your 

comments have maximum effect in 

developing the notice of final priority, 

requirements, and definitions, we urge 

you to clearly identify the specific 

priority, requirement, or definition that 

each comment addresses. 

Specific Requests for Comment: The 

Department is particularly interested in 

comments regarding the best way for the 

NVRTAC to prioritize among VR 

agencies needing intensive training and 

technical assistance. We are also 

interested in comments regarding 

whether the project requirements and 

related activities under the proposed 

priority reflect the greatest needs in the 

field and can assist the State VR 


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