Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages, 42260-42270 [E6-11872]

Agencies

• Alcohol and Tobacco Tax and Trade Bureau
• DEPARTMENT OF THE TREASURY

[Federal Register Volume 71, Number 143 (Wednesday, July 26, 2006)]
[Rules and Regulations]
[Pages 42260-42270]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11872]


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DEPARTMENT OF THE TREASURY

Alcohol and Tobacco Tax and Trade Bureau

27 CFR Parts 4, 5, and 7

[T.D. TTB-53; Re: Notice No. 62]
RIN 1513-AB08


Major Food Allergen Labeling for Wines, Distilled Spirits, and 
Malt Beverages

AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury.

ACTION: Interim rule; Treasury decision.

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SUMMARY: This interim rule, which parallels the recent amendments to 
the Federal Food, Drug and Cosmetic Act contained in the Food Allergen 
Labeling and Consumer Protection Act of 2004, adopts labeling standards 
for major food allergens used in the production of alcohol beverages 
subject to the labeling requirements of the Federal Alcohol 
Administration Act.
    In addition, elsewhere in this issue of the Federal Register, we 
are publishing a notice of proposed rulemaking that proposes to make 
major food allergen labeling mandatory. That notice solicits comments 
from the public, including consumers and affected industry members, on 
the proposed labeling requirements and the time frame for making the 
requirements mandatory.
    Under the interim regulations, producers, bottlers, and importers 
of wines, distilled spirits, and malt beverages may voluntarily declare 
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, in their products, but are not 
required to do so. The interim regulations, however, set forth rules 
that are mandatory for how industry members must undertake such 
labeling, should they choose to do so. The regulations also contain 
procedures for petitioning for an exemption from the standards imposed 
on those alcohol beverage producers who wish to make voluntary allergen 
statements on their product labels.

DATES: Effective Date: This interim rule is effective on July 26, 2006.

FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, Regulations and 
Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 
128, Morganza, MD 20660; telephone (301) 290-1460.

SUPPLEMENTARY INFORMATION: 

I. Background

    In recent years, the presence of food allergens in foods has become 
a matter of public concern. In response, Congress passed the Food 
Allergen Labeling and Consumer Protection Act of 2004 to require the 
declaration in labeling of major food allergens in plain, common 
language on the foods regulated under the Federal Food, Drug and 
Cosmetic Act. A House of Representatives committee report also noted 
that the committee expected the Alcohol and Tobacco Tax and Trade 
Bureau (TTB) to issue regulations on allergen labeling for alcohol 
beverage products under TTB's existing authority to regulate alcohol 
beverage labeling, working in cooperation with the Food and Drug 
Administration (FDA). In addition, TTB had earlier received a petition 
concerning ingredient and allergen labeling for alcohol beverages. In 
response, TTB is issuing these interim regulations regarding voluntary 
labeling of major food allergens used in the production of alcohol 
beverage products. TTB also is proposing mandatory major food allergen 
labeling for alcohol beverage products in a notice of proposed 
rulemaking published elsewhere in this issue of the Federal Register.

A. FAA Act

    TTB is responsible for the administration of the Federal Alcohol 
Administration Act, 27 U.S.C. 201 et seq., (FAA Act), which governs, 
among other things, the labeling of wines containing at least 7 percent 
alcohol by volume, distilled spirits, and malt beverages in interstate 
and foreign commerce. These products are generically referred to as 
``alcohol beverages'' or ``alcohol beverage products'' throughout this 
document.
    In particular, section 105(e) of the FAA Act (27 U.S.C. 205(e)) 
gives the Secretary of the Treasury authority to issue regulations 
regarding the labeling of alcohol beverages to provide the consumer 
with adequate information concerning the identity and quality of such 
products, to prevent deception of the consumer, and to prohibit false 
or misleading statements. Section 105(e) also makes it unlawful for 
industry members ``to sell or ship or deliver for sale or shipment, or 
otherwise introduce in interstate or foreign commerce, or to receive 
therein, or to remove from customs custody for consumption, any 
distilled spirits, wine, or malt beverages in bottles, unless such 
products are bottled, packaged, and labeled in conformity'' with 
regulations prescribed by the Secretary. Regulations setting forth 
mandatory labeling information requirements for wine, distilled 
spirits, and malt beverages are contained, respectively, in parts 4, 5, 
and 7 of the TTB regulations (27 CFR parts 4, 5, and 7).
    Most of the mandatory labeling requirements found in parts 4, 5, 
and 7 flow directly from the stated purpose of section 105(e) of the 
FAA Act, that is, to ``provide the consumer with adequate information 
as to the identity and quality of the products, the alcoholic content 
thereof * * *, the net contents of the package, and the manufacturer or 
bottler or importer of the product.'' Currently, the TTB labeling 
regulations contained in parts 4, 5, and 7 require the following 
information to appear on alcohol beverage labels: Brand name; product 
identity (class or type); the name and address of the bottler, packer, 
or importer; the net contents; and the alcohol content of distilled 
spirits, certain flavored malt beverage products, and wines over 14 
percent alcohol by volume. Labels for wines with 14 percent alcohol by 
volume or less may contain either an alcohol content statement or the 
type designation

[[Page 42261]]

``table'' wine or ``light'' wine (see 27 CFR part 4.36(a)). In 
addition, labels must note the presence of sulfites, FD&C Yellow No. 5, 
and in the case of malt beverages, aspartame. A health warning 
statement applicable to all alcohol beverages containing 0.5 percent or 
more alcohol by volume is 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 Health-Risk Ingredient Disclosure on Alcohol Beverage Labels

    Our 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.)
    These rulemaking actions included publication of T.D. ATF-150 (48 
FR 45549, October 6, 1983), which rescinded the ingredient disclosure 
regulations that had been published in T.D. ATF-66 (45 FR 40538, June 
13, 1980), but never implemented. T.D. ATF-150 did, however, mandate 
the disclosure of one ingredient, FD&C Yellow No. 5, on alcohol 
beverage labels. In the preamble to T.D. ATF-150, ATF stated:

    * * * there is 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 under 5 U.S.C. 553(e) and 27 CFR 71.41(c).

    In conformity with that case-by-case review policy, ATF 
subsequently issued 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.
    In 1987, ATF entered into a Memorandum of Understanding (MOU) with 
FDA. See 52 FR 45502 (November 30, 1987). In the MOU, ATF made a 
commitment to consult with FDA regarding the necessity of requiring 
labeling statements for ingredients in alcohol beverages that pose a 
recognized public health problem and to initiate rulemaking proceedings 
to require disclosure of such ingredients where appropriate. The 
pertinent portion of the MOU states:

    ATF will be responsible for the promulgation and enforcement of 
regulations with respect to the labeling of distilled spirits, wine, 
and malt beverages pursuant to the FAA Act. When FDA has determined 
that the presence of an ingredient in food products, including 
alcoholic beverages, poses a recognized public health problem, and 
that the ingredient or substance must be identified on a food 
product label, ATF will initiate rulemaking proceedings to 
promulgate labeling regulations for alcoholic beverages consistent 
with ATF's health policy with respect to alcoholic beverages. ATF 
and FDA will consult on a regular basis concerning the propriety of 
promulgating regulations concerning the labeling of other 
ingredients and substances for alcoholic beverages.

    Pursuant to the policies set forth in the MOU, ATF subsequently 
issued 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). It should be noted that FD&C Yellow No. 5, sulfites, 
and aspartame are not considered food allergens because they do not 
cause IgE (Immunoglobulin E)-mediated responses, but they may cause 
health problems in certain individuals.

C. Petition From Dr. Christine Rogers

    On April 10, 2004, Christine A. Rogers, PhD., a senior research 
scientist in the Exposure, Epidemiology and Risk Program at the Harvard 
School of Public Health, petitioned TTB to change the regulations to 
require labeling of all ingredients and substances used in the 
production of alcohol beverages.
    Dr. Rogers stated that she is allergic to egg protein and that she 
has had allergic reactions to egg in wine. For that reason, she 
expressed particular concern with the labeling of allergenic substances 
in alcohol beverage products. Dr. Rogers noted that allergic symptoms 
in consumers can include tingling or itching in the mouth, salivation, 
swelling of tissues, hives, abdominal cramps, vomiting, diarrhea, rapid 
loss of blood pressure, and death. She explained that allergic 
reactions to food vary based upon an individual's sensitivity to a 
particular allergen. The most sensitive allergic individuals are 
required to carry epinephrine with them for emergency use in the case 
of exposure to an offending allergen.

D. Enactment of FALCPA

    On August 2, 2004, the President signed into law the Food Allergen 
Labeling and Consumer Protection Act of 2004 (FALCPA) (see title II of 
Pub. L. 108-282, 118 Stat. 905). FALCPA amends portions of the Federal 
Food, Drug and Cosmetic Act (FD&C Act, 21 U.S.C. 301, et seq.) to 
require a food that is, or contains an ingredient that bears or 
contains, a major food allergen to list this information on its label 
using plain, common language. 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 
FALCPA amendments define ``major food allergens'' as milk, egg, fish, 
Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well 
as most ingredients containing proteins derived from these foods.
    The effect of the FALCPA amendments is to add additional allergen 
information to the food label. 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''; or
     The label can list the name of the food source from which 
the allergen is derived in summary form after, or adjacent to, an 
ingredient list, for example: ``Ingredients: Water, sugar, whey, and 
albumen. Contains: Milk and egg.''
    Section 202 of FALCPA contains a number of congressional findings 
regarding the health risk posed by allergens. Congress found that 
approximately 2 percent of adults and 5 percent of infants and young 
children in the United States suffer from food allergies. Each year, 
roughly 30,000 individuals require emergency room treatment and 150 
individuals die because of allergic reactions to food.
    Congress found that the eight foods or food groups identified in 
FALCPA account for 90 percent of all food allergies. Since there is 
currently no cure for food allergies, a food-allergic consumer must 
avoid the food to which he or she is allergic. Congress further found 
that many consumers may not realize that a labeled food ingredient is 
derived from, or contains, a major food allergen. The FALCPA amendments 
fill this gap by ensuring that the food source from which a major food 
allergen is derived is clearly labeled in plain language.
    FALCPA amends food labeling requirements in the FD&C Act. Pursuant 
to authority delegated to it by the Secretary of Health and Human 
Services, FDA is responsible for promoting and protecting the public 
health through enforcement of the FD&C

[[Page 42262]]

Act and for ensuring that the nation's food supply is properly labeled. 
However, it is TTB's responsibility to issue regulations with respect 
to the labeling of wine, distilled spirits, and malt beverages under 
the FAA Act. See the 1987 ATF-FDA MOU and Brown-Forman Distillers Corp. 
v. Mathews, 435 F. Supp. 5 (W.D. Ky. 1976).
    The allergen labeling requirements in FALCPA apply to any food, as 
that term is defined in section 201(f) of the FD&C Act, other than raw 
agricultural commodities. As reflected in the 1987 MOU with FDA, TTB is 
responsible for the promulgation and enforcement of regulations with 
respect to the labeling of distilled spirits, wines, and malt beverages 
pursuant to the FAA Act. The House of Representatives Committee on 
Energy and Commerce called for TTB to work with FDA to promulgate 
appropriate allergen labeling regulations for alcohol beverages labeled 
under the FAA Act and TTB 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 called on TTB to work with FDA to promulgate 
appropriate allergen labeling regulations for alcohol beverages. The 
clear intent reflected in the House committee report is that TTB issue 
regulations similar to the FALCPA standards, pursuant to the policies 
expressed in the MOU with FDA and the authority of the FAA Act.
    Under the MOU, the two agencies have over the years collaborated on 
many food safety issues and continue to exchange a wide variety of 
information, including relevant consumer complaints concerning the 
adulteration of alcohol beverages. The agencies consult regularly 
concerning the use and labeling of potentially harmful ingredients and 
substances in alcohol beverages. The laboratories of FDA and TTB 
regularly exchange information concerning methodologies and techniques 
for testing alcohol beverages.
    Consistent with the expectations expressed in the House committee 
report, TTB consulted with FDA prior to issuing this interim rule. 
However, it should be emphasized that while this interim rule is 
promulgated in response to, among other things, the expectations set 
out in the legislative history of FALCPA, TTB's legal authority to 
establish this rule is based on the FAA Act.
    FDA is the agency authorized to implement FALCPA with regard to 
foods. The House committee has set forth its expectation that TTB will 
implement allergen labeling for alcohol beverages, as appropriate, and 
will work with FDA in this effort. While TTB has generally strived to 
be consistent with FDA's interpretation of FALCPA, the implementation 
of regulations regarding major food allergen labeling for alcohol 
beverages under the FAA Act will necessarily differ in some respects 
from the requirements of FALCPA.
    Accordingly, this interim rule reflects TTB's interpretation of its 
authority under the FAA Act, as guided by the language in the committee 
report. This regulation does not necessarily represent the views of FDA 
with regard to allergen labeling or the requirements of FALCPA.

II. Rulemaking History and Summary of Comments

    On April 29, 2005, TTB published in the Federal Register (70 FR 
22274) Notice No. 41, an advance notice of proposed rulemaking (the 
ANPRM). The notice was entitled ``Labeling and Advertising of Wines, 
Distilled Spirits and Malt Beverages; Request for Public Comment.'' We 
provided a 60-day period for comments from consumers, interest groups, 
trade associations, industry, and other members of the public on 
several alcohol beverage labeling issues, including calorie and 
carbohydrate claims on labels, ``serving facts'' labeling, ``alcohol 
facts'' labeling, ingredient labeling, allergen labeling, and composite 
label approaches.
    In the ANPRM, we invited comments on specific issues related to 
allergen labeling, including: Whether our 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 we should consider threshold levels in allergen labeling; what 
costs industry may incur from new labeling requirements; and how 
consumers might benefit from allergen labeling. We also invited 
submission of any other relevant information on the subject of allergen 
labeling.
    During the 60-day comment period, we received several requests from 
alcohol beverage industry representatives and organizations to extend 
the comment period for an additional 60 to 90 days beyond the original 
June 28, 2005, closing date. In support of the extension requests, 
industry members noted that some of the questions posed in the notice 
were broad and far reaching from a policy standpoint while others were 
very technical, requiring research and coordination within the affected 
industries. In response to these requests, we extended the comment 
period for an additional 90 days. See Notice No. 48, 70 FR 36359, June 
23, 2005. The extended comment period for the ANPRM closed on September 
26, 2005.
    We received more than 18,000 comments in response to the ANPRM, 
approximately 50 of which specifically addressed the subject of 
allergen labeling. Based on the clearly expressed congressional 
interest in allergen labeling, the particular risks that allergens pose 
to human health, FALCPA's effective date of January 1, 2006, and the 
relatively small number of comments submitted on allergen issues, we 
have decided to separate the allergen labeling rulemaking from the 
other issues discussed in the ANPRM. We will review the comments 
submitted on the other ANPRM issues, with a view to determining whether 
to proceed with future rulemaking action in those areas, separately 
from our action on allergen labeling. Accordingly, this document only 
addresses allergen issues, including the approximately 50 comments on 
allergens submitted in response to the ANPRM.
    We note that of the comments we received on allergens, the vast 
majority favored mandatory labeling of the major food allergens. 
Industry members as well as consumer and public health advocates 
commented in support of major food allergen labeling.
    The major trade associations representing the alcohol beverage 
industry expressed their support for mandatory labeling of major food 
allergens. The Beer Institute, the Brewers Association, the Distilled 
Spirits Council of the United States (DISCUS), the National Association 
of Beverage Importers (NABI), the Presidents' Forum, Spirits Canada, 
Wine America, and the Wine Institute submitted a consolidated comment, 
in which they stated that they fully

[[Page 42263]]

supported the purpose and objectives of FALCPA and stood ready to work 
with TTB in the implementation of allergen labeling. In a separate 
comment, the Brewers Association stated that ``mandatory rules 
regarding the disclosure of major allergens are necessary because 
certain types of allergens, or at least when present above 
scientifically determined harmful levels, can pose a significant threat 
to consumer health.''
    Consumer and public health interest groups also submitted comments 
in support of mandatory labeling of major food allergens. The National 
Consumers League (NCL) submitted a comment supported by several groups, 
including the American Public Health Association and the American 
School Health Association. This comment urged TTB to adopt a uniform, 
mandatory labeling regime for all alcohol beverages that includes, 
among other things, an ingredient declaration listing each ingredient 
by its common or usual name and identifying any major food allergens 
present in the product. The Center for Science in the Public Interest 
(CSPI), a nonprofit health education and advocacy organization, 
submitted a comment in support of the adoption of a mandatory allergen 
disclosure policy for alcohol beverages consistent with the FALCPA 
requirements for food and the FDA policies implementing FALCPA.
    We also received comments in support of allergen labeling from the 
American Medical Association; the American Academy of Allergy, Asthma 
and Immunology; the American College of Allergy, Asthma and Immunology; 
the Food Allergy and Anaphylaxis Network; the American Council on 
Science and Health; the American Society of Addiction Medicine; the 
American Dietetic Association; the American Nurses Association; Shape 
Up America; and several other public health organizations and health 
professionals.
    Only a few comments questioned the usefulness of requiring allergen 
information on alcohol beverage labels. Furthermore, there were some 
disagreements among the commenters about the allergen labeling 
implementation issues that we raised in the ANPRM.

III. Interim Regulatory Changes

    After careful consideration of the comments on this issue, TTB has 
determined that it should propose rules for the mandatory labeling of 
major food allergens used in the production of alcohol beverages. 
Consistent with the guidance expressed in the House committee report 
and our statutory mandate under the FAA Act to promulgate regulations 
ensuring that consumers receive adequate information about the identity 
and quality of alcohol beverages, we believe 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 allergic consumers may make an informed decision as to whether 
consumption of a particular beverage may pose a risk of an allergic 
reaction. Accordingly, we are proposing mandatory labeling of major 
food allergens elsewhere in this issue of the Federal Register.
    As explained below, we are issuing this interim rule to provide 
immediate guidance to industry members who wish to place allergen 
statements on alcohol beverage labels on a voluntary basis. The interim 
regulations also allow for the immediate filing of petitions for 
exemptions from the standards imposed on those producers who wish to 
make voluntary allergen statements on their labels.

A. Voluntary Labeling Approach

    We note that in response to the ANPRM, some commenters urged TTB to 
require labeling of major food allergens for products labeled on or 
after January 1, 2006, which is the effective date of the FALCPA 
amendments. One commenter suggested that consumers will expect to see 
allergen information on alcohol beverage products at the same time that 
such information begins appearing on food labels under FALCPA, and that 
they may be misled by the absence of such information on labels of 
products that in fact contain major food allergens. Other commenters, 
recognizing that it may take some time before a final rule is issued, 
suggested that TTB allow voluntary labeling of major food allergens 
pending the completion of rulemaking.
    In this regard, it should be noted that the congressional 
committees involved with FALCPA had different expectations of FDA and 
of TTB. The report of the Senate Committee on Health, Education, Labor, 
and Pensions, S. Rep. No. 226, 108th Cong., 2d Sess., at 10 (2004) 
(hereafter ``Senate committee report''), states:

    The committee intends the requirements of section 403(w) to be 
self-implementing. FDA will not be required to issue regulations to 
implement section 403(w). FDA may issue guidance, should the agency 
find that guidance would assist manufacturers or distributors, 
particularly small businesses, to comply with the requirements in 
this legislation.

    On the other hand, as previously noted, the House committee report 
specifically stated its expectation that TTB would promulgate 
regulations, in consultation with FDA, to apply allergen labeling 
requirements to alcohol beverages, as appropriate. Given that the TTB 
regulations must be amended in order to implement allergen labeling, we 
believe it is appropriate to allow the public, including affected 
industry members, the opportunity to comment on allergen labeling 
standards before making them mandatory.
    Accordingly, in order to make allergen labeling standards 
applicable to alcohol beverages at the earliest practicable date, and 
before the public comment procedures can be completed, TTB has 
determined that the best approach is to adopt voluntary regulatory 
standards for major food allergen labeling through an interim rule. TTB 
agrees with those commenters who suggested that producers of alcohol 
beverages be given immediate guidance with respect to the voluntary use 
of allergen labeling statements on labels. We have already received 
inquiries from industry members about the voluntary use of allergen 
statements on alcohol beverage labels. Because industry members may 
wish to begin providing allergen information to consumers on a 
voluntary basis right away, we are publishing standards that are 
effective immediately.
    The interim rule also gives industry members an opportunity to file 
petitions for exemption from the standards imposed on those alcohol 
beverage producers who wish to make voluntary allergen statements on 
their product labels.
    This interim rule amends parts 4, 5, and 7 of the TTB regulations 
to include specific requirements for those who choose to place 
voluntary declarations of major food allergens on labels. The 
amendments include the addition of new sections 4.32a, 5.32a, and 
7.22a, which set forth specific format requirements for the voluntary 
labeling of major food allergens. In addition, we have added new 
sections 4.32b, 5.32b, and 7.22b, which allow any person to petition 
TTB for an exemption from the labeling standards that apply if 
voluntary major food allergen labeling is undertaken. A detailed 
discussion of the specific provisions within the interim regulations 
follows.
    In consideration of the requirements for prior public notice and 
comment procedures under the Administrative Procedure Act, we are 
proposing the adoption of mandatory labeling standards in a separate 
document, Notice No. 62, which is published in the

[[Page 42264]]

Proposed Rules section of this issue of the Federal Register. The 
voluntary standards adopted in this interim rule document will remain 
in place until they are replaced by final action on the proposal for 
mandatory standards.

B. Labeling of Major Food Allergens

1. Definitions
    Consistent with the FALCPA amendments, the interim regulations 
provide that when allergen labeling is undertaken, the product must be 
labeled ``Contains:'' followed by the name of the food source from 
which each major food allergen is derived, as set forth in the 
definition of ``major food allergen.''
    The definition of the term ``major food allergen'' is consistent 
with the statutory definition in FALCPA. The interim 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, and soybeans.'' The term as 
defined also includes any food ingredient that contains protein derived 
from one of these eight foods or food groups, subject to certain 
exceptions explained below.
    It should be noted that, consistent with guidance provided by FDA 
to the food industry, the interim regulations allow the terms 
``soybean,'' ``soy,'' and ``soya'' as synonyms for the term 
``soybeans,'' as used in the statute. Furthermore, also 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.
2. Labeling of Fish Species
    FALCPA provides that in the case of tree nuts, the label must list 
the name of the specific type of nut (for example, almonds, pecans, or 
walnuts). In the case of Crustacean shellfish, the label must list the 
name of the species of shellfish (for example, crab, lobster, or 
shrimp). Finally, in the case of fish, the FALCPA amendments provide 
that the name of the species of fish (for example, bass, flounder, or 
cod) must appear on the label.
    The interim regulations are consistent with the FALCPA amendments 
with respect to the labeling of tree nuts and Crustacean shellfish. 
However, for the reasons explained below, the interim regulations set 
forth in this document do not require labeling of the specific fish 
species when an industry member chooses to provide major food allergen 
information. The regulations 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 most often is made from cod skins but can be made 
from any species of fish.
    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 particular species of fish was used to 
make the product. Moreover, it may be difficult for industry members to 
determine by chemical analysis which particular fish species was the 
source of the isinglass or fish gelatin.
    On August 1, 2005, the Flavor and Extract Manufacturers Association 
of the United States (FEMA) submitted a request to FDA for guidance 
concerning the labeling of fish species under the FALCPA amendments. In 
its request for guidance, FEMA asked FDA to allow for use of the term 
``fish'' for labeling ``non-nutritive fish ingredients'' used in 
flavors. FEMA cited clinical and scientific evidence in support of its 
argument that many fish-allergic individuals will react adversely to 
more than one species of fish.
    TTB recognizes that FALCPA requires the labeling of the particular 
species of fish used as an ingredient in a food product. However, it is 
our responsibility to implement allergen labeling regulations that are 
appropriate for alcohol beverages. 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. 
Because of the particular difficulty faced by the producer 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, TTB is persuaded that 
requiring labeling with the name of the specific type of fish would 
impose a difficult fact-finding burden on the alcohol beverage industry 
without offering consumers who may be allergic to more than one species 
of fish any significant additional information to help them avoid the 
risk of an allergic reaction. Accordingly, we believe that the goal of 
the FALCPA amendments with respect to alcohol beverages is adequately 
met if alcohol beverages produced using finfish protein are labeled 
merely with ``fish,'' rather than with the name of the fish species.
    We would note that the data on this matter are not conclusive, and 
we are specifically inviting comments on this issue in our notice of 
proposed rulemaking. However, for purposes of the guidance provided in 
this interim rule for industry members who wish to make voluntary 
allergen labeling statements, we believe that there is a basis for 
concluding that a reference to ``fish'' on the label will provide 
adequate information to consumers about the presence of finfish protein 
in certain alcohol beverages.
3. Processing and Fining Agents
    FALCPA amends the FD&C Act to require that, notwithstanding any 
other provision of law, a flavoring, coloring, or incidental additive 
that is or bears or contains a major food allergen must conform to 
FALCPA's labeling requirements. See 21 U.S.C. 343(w)(4). The FDA 
regulations define the term ``incidental additive'' to include, among 
other things, processing aids. See 21 CFR 101.100(a)(3). Therefore, if 
alcohol beverage industry members choose to make major food allergen 
declarations, the interim regulations treat major food allergens used 
as fining or processing agents in the same way as any other major food 
allergen used in the production of the alcohol beverage.
4. Threshold Levels
    The FALCPA amendments, which took effect for foods labeled on or 
after January 1, 2006, require allergen labeling for foods regulated by 
FDA without the establishment of any threshold levels for labeling. 
Furthermore, pursuant to our authority under the FAA Act to ensure that 
labels provide consumers with adequate information about the identity 
and quality of alcohol beverage products, the interim regulations 
provide that if an industry member chooses to label for any major food 
allergen, 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. Accordingly, TTB is not setting 
thresholds in this interim regulation.
    TTB believes that this position will ensure that consumers have 
adequate information about the potential presence of even trace amounts 
of major food allergens in alcohol beverage products. As more accurate 
scientific data become available in the future, we may revisit the 
threshold issue as appropriate.

[[Page 42265]]

C. Exceptions From Allergen Labeling Requirements

    The interim regulations contain three exceptions from major food 
allergen labeling. Two of these exceptions are provided within the 
definition of ``major food allergen,'' and the third is an exemption 
through a TTB petition process.
1. Highly Refined Oil
    The FALCPA amendments exclude from the definition of ``major food 
allergen'' any highly refined oil derived from one of the eight foods 
or food groups listed in that definition and any ingredient derived 
from such highly refined oil. The Senate committee report at page 7 
indicates that the exception for highly refined oils was intended to 
apply to refined, bleached, deodorized (RBD) oils. Both the House 
committee report at page 16 and the Senate committee report at page 7 
specifically identify peanut oil as one of the highly refined oils 
covered by the exception. We believe this exception from labeling for 
highly refined oils is also appropriate in the case of alcohol 
beverages, and we therefore have included this as an exception from the 
definition of a major food allergen in the interim regulatory texts.
2. Exemptions Under the FD&C Act
    FALCPA added two processes 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 an ingredient ``does 
not contain allergenic protein.'' The scientific evidence must include 
the analytical method used to produce the evidence that the 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 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 is exempt from the FDA 
labeling requirements for major food allergens.
    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. Under the two exemption processes described above, 
certain ingredients and food additives may be exempted from the 
allergen labeling requirements of the FD&C Act. We believe it is 
appropriate to allow alcohol beverage industry members to rely on the 
exemptions from major food allergen labeling requirements allowed under 
the FD&C Act and FDA procedures. We have therefore included in the 
definition of ``major food allergen'' an exception for uses of food 
ingredients that are exempt pursuant to 21 U.S.C. 343(w)(6) or (7).
    It is important to note in this regard that alcohol beverage 
industry members must consider two issues when determining whether an 
ingredient exempted under the FD&C Act is also not subject to TTB 
allergen labeling requirements. First, the ingredient they used or 
intend to use in a product must be the same ingredient that is exempt 
under the FD&C Act. Second, the proposed use must be consistent with 
any conditions of use in the FD&C Act exemption for the ingredient.
3. Petitions for Exemption From TTB Regulations
    We also recognize 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, new 
sections 4.32a, 5.32a, and 7.22a refer in each case to an exception for 
a product covered by a petition for exemption approved under new 
section 4.32b, 5.32b, or 7.22b. 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.
    As stated above, TTB's jurisdiction extends to the labeling of 
wines, distilled spirits, and malt beverages. Accordingly, we only will 
accept a petition seeking an exemption from the labeling of a major 
food allergen when the material in question is used in the production 
of an alcohol beverage product regulated by TTB. If an exemption from 
the FD&C Act allergen labeling requirements is also desired, the 
interested party must submit a petition or notification to FDA under 21 
U.S.C. 343(w)(6) or (7), rather than submit a petition under the 
applicable TTB regulation.
    The use of the TTB petition process is similar to 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 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. We believe that 
having one petition procedure, rather than separate petition and 
notification procedures, will simplify the process for industry, and 
will allow our personnel adequate time to review the evidence presented 
in each request for an exemption. TTB is not in a position to 
administer a 90-day notice procedure similar to the notification 
procedure in subsection (w)(7) of the statute. The interim regulation 
petition procedure is therefore similar to the petition procedure in 
subsection (w)(6) of the statute in that the regulation places the 
burden on the petitioner to provide evidence in support of the 
exemption and gives TTB 180 days to respond.
    The interim regulations provide that a petition for exemption from 
major food allergen labeling must be submitted to the appropriate TTB 
officer. The appropriate TTB officer to whom petitions must be 
submitted is the Assistant Administrator, Headquarters Operations. The 
petition should be sent to the Alcohol and Tobacco Tax and Trade 
Bureau, 1310 G Street NW., Suite 200E, Washington, DC 20220 and should 
bear the notation: ``Attention: Petition for Exemption from Major Food 
Allergen Labeling'' to ensure prompt processing.

[[Page 42266]]

    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. 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.
    As a result of FDA's implementation of FALCPA and our establishment 
of this interim rule, TTB and FDA will both be regulating allergen 
labeling, with TTB overseeing labeling for alcohol beverages and FDA 
the labeling for all other products that are foods under the FD&C Act. 
As noted, TTB and FDA are parties to an MOU signed in 1987. That MOU 
provides that FDA and TTB will exchange information generally about 
appropriate labeling for, and the adulteration of, alcohol beverages, 
including information about methodologies and techniques for testing 
such beverages. Consistent with these general MOU provisions and both 
agencies' recognition that, generally, the regulation of allergen 
labeling should be consistent for alcohol beverages and all other 
foods, TTB intends to confer with FDA, as appropriate and as FDA 
resources permit, on petitions submitted under this interim rule.
    Consistent with FALCPA, the interim rule places the burden on the 
petitioner to provide adequate evidence in its initial petition 
submission to justify an exemption from labeling. TTB may require the 
subsequent submission of product samples and other additional 
information in support of a petition; however, unless required by TTB, 
the submission of samples or additional information by the petitioner 
after submission of the petition will be treated as the withdrawal of 
the initial petition and the submission of a new petition.
    FALCPA provides that FDA shall promptly post to a public site all 
petitions within 14 days of receipt and shall promptly post the 
Government's response to each. Our interim regulations are consistent 
with FALCPA's requirement to make petitions and responses available to 
the public, but may go beyond the requirements of FALCPA in some 
respects. The interim regulations provide that petitions submitted to 
TTB, and TTB's response to those petitions, will be posted to the TTB 
Web site (https://www.ttb.gov). However, TTB will not post lengthy 
materials submitted in support of a petition on its Web site; we will, 
instead, make such materials available to the public in accordance with 
the procedures set forth in the Freedom of Information Act, 5 U.S.C. 
552.
    A person who provides trade secrets or other confidential 
commercial or financial information in either a petition for exemption 
or in any supporting documentation submitted in connection with such a 
petition may request that TTB give confidential treatment to that 
information. The interim regulations set forth the standards for making 
such a request. A failure to request confidential treatment at the time 
the information in question is submitted to TTB will constitute a 
waiver of confidential treatment.

IV. Notice of Proposed Rulemaking

    In the Proposed Rules section of this issue of the Federal 
Register, we have published a notice of proposed rulemaking, Notice No. 
62, to solicit public comment on our proposal to impose mandatory 
allergen labeling requirements on alcohol beverage products. That 
notice gives the public, including affected industry members, an 
opportunity to comment on the mandatory labeling of major food 
allergens, the time required by industry members to incorporate the 
required changes on their labels, and how to minimize any added 
compliance costs.

V. Regulatory Analysis and Notices

A. Executive Order 12866

    We have determined that this interim rule is not a significant 
regulatory action as defined in Executive Order 12866. Therefore, a 
regulatory assessment is not required.

B. Regulatory Flexibility Act

    Because this interim rule was not required to be preceded by a 
notice of proposed rulemaking, the provisions of the Regulatory 
Flexibility Act (5 U.S.C. 601 et seq.) do not apply.

C. Paperwork Reduction Act

    This interim rule includes a new collection of information 
involving the declaration of major food allergens on an alcohol 
beverage label and the submission of petitions for exemption from 
allergen labeling. This collection is voluntary.
    The collection of information has been reviewed and, pending 
receipt and evaluation of public comments, approved by the Office of 
Management and Budget (OMB) under 44 U.S.C. 3507(j) and assigned 
control number 1513-0121. 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 collection of information is contained in Sec. Sec.  4.32a, 
4.32b, 5.32a, 5.32b, 7.22a, and 7.22b. The likely respondents are 
individuals and business or other for-profit institutions, including 
partnerships, associations, and corporations.
     Estimated total annual reporting and/or recordkeeping 
burden: 730 hours.
     Estimated average annual burden per respondent/
recordkeeper: 1.46 hours.
     Estimated number or respondents and/or recordkeepers: 500.
     Estimated annual number of responses: 520.
    Comments on this collection of information may be sent by e-mail to 
OMB at Alexander--T.--Hunt@omb.eop.gov, or by paper mail to Office of 
Management and Budget, Attention: Desk Officer for the Department of 
the Treasury, Office of Information and Regulatory Affairs, Washington, 
DC 20503. A copy should also be sent to TTB at one of the following 
addresses:
     P.O. Box 14412, Washington, DC 20044-4412;
     202-927-8525 (facsimile); or
     formcomments@ttb.gov (e-mail).
    Please reference the information collection's title and OMB number 
in your comment. If you submit your comment via facsimile, send no more 
than five 8.5 x 11 inch pages in order to ensure electronic access to 
our equipment.
    Comments are invited on the accuracy of the burden. We also invite 
suggestions on how the burden may be reduced.

VI. Inapplicability of Prior Notice and Comment and Delayed Effective 
Date Procedures

    It has been determined, pursuant to 5 U.S.C. 553(b)(B) and (d), 
that good cause exists to issue these regulations without prior notice 
and public procedure, and without a delayed effective date. Because the 
industry needs immediate standards for the placement of voluntary 
statements listing major food allergens on alcohol beverage labels, and 
because industry members may wish to begin immediately to submit 
petitions for exemptions, it is impracticable and contrary to the 
public interest to issue these regulations for prior notice and 
comment, and with a delayed effective date.

[[Page 42267]]

VII. Drafting Information

    The principal author of this document was Jessica M. Bungard, 
Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade 
Bureau. However, other personnel participated in its development.

List of Subjects

27 CFR Part 4

    Administrative practice and procedure, Advertising, Customs duties 
and inspection, Imports, Labeling, Packaging and containers, Reporting 
and recordkeeping requirements, Trade practices, Wine.

27 CFR Part 5

    Administrative practice and procedure, Advertising, Customs duties 
and inspection, Distilled spirits, Imports, Labeling, Packaging and 
containers, Reporting and recordkeeping requirements, Trade practices.

27 CFR Part 7

    Administrative practice and procedure, Advertising, Customs duties 
and inspection, Imports, Labeling, Malt beverages, Reporting and 
recordkeeping requirements, Trade practices.

Amendments to the Regulations

0
For the reasons discussed in the preamble, TTB amends 27 CFR parts 4, 
5, and 7 as follows:

PART 4--LABELING AND ADVERTISING OF WINE

0
1. The authority citation for 27 CFR part 4 continues to read as 
follows:

    Authority: 27 U.S.C. 205.


0
2. A new Sec.  4.32a is added to read as follows:


Sec.  4.32a  Voluntary disclosure of major food allergens.

    (a) Definitions. For purposes of this section the following terms 
have the meanings indicated.
    (1) Major food allergen. Major food allergen means any of the 
following:
    (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, and 
soybeans; or
    (ii) A food ingredient that contains protein derived from a food 
specified in paragraph (a)(1)(i) of this section, except:
    (A) Any highly refined oil derived from a food specified in 
paragraph (a)(1)(i) of this section and any ingredient derived from 
such highly refined oil; or
    (B) A food ingredient that is exempt from major food allergen 
labeling requirements pursuant to a petition for exemption approved by 
the Food and Drug Administration (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.
    (2) Name of the food source from which each major food allergen is 
derived. Name of the food source from which each major food allergen is 
derived means the name of the food as listed in paragraph (a)(1)(i) of 
this section, except that:
    (i) In the case of a tree nut, it means the name of the specific 
type of nut (for example, almonds, pecans, or walnuts);
    (ii) In the case of Crustacean shellfish, it means the name of the 
species of Crustacean shellfish (for example, crab, lobster, or 
shrimp); and
    (iii) The names ``egg'' and ``peanuts'', as well as the names of 
the different types of tree nuts, may be expressed in either the 
singular or plural form, and the term ``soy'', soybean'', or ``soya'' 
may be used instead of ``soybeans''.
    (b) Voluntary labeling standards. Major food allergens (defined in 
paragraph (a)(1) of this section) used in the production of a wine may, 
on a voluntary basis, be declared on any label affixed to the 
container. However, if any one major food allergen is voluntarily 
declared, all major food allergens used in production of the wine, 
including major food allergens used as fining or processing agents, 
must be declared, except when covered by a petition for exemption 
approved by the appropriate TTB officer under Sec.  4.32b. The major 
food allergens declaration must consist of the word ``Contains'' 
followed by a colon and the name of the food source from which each 
major food allergen is derived (for example, ``Contains: egg'').
    (c) Cross reference. For mandatory labeling requirements applicable 
to wines containing FD&C Yellow No. 5 and sulfites, see Sec. Sec.  
4.32(c) and (e).


0
3. A new Sec.  4.32b is added to read as follows:


Sec.  4.32b  Petitions for exemption from major food allergen labeling.

    (a) Submission of petition. Any person may petition the appropriate 
TTB officer to exempt a particular product or class of products from 
the labeling requirements of Sec.  4.32a. The burden is on the 
petitioner to provide scientific evidence (including the analytical 
method used to produce the evidence) that demonstrates that the 
finished product or class of products, as derived by the method 
specified in the petition, either:
    (1) Does not cause an allergic response that poses a risk to human 
health; or
    (2) Does not contain allergenic protein derived from one of the 
foods identified in Sec.  4.32a(a)(1)(i), even though a major food 
allergen was used in production.
    (b) Decision on petition. TTB will approve or deny a petition for 
exemption submitted under paragraph (a) of this section in writing 
within 180 days of receipt of the petition. If TTB does not provide a 
written response to the petitioner within that 180-day period, the 
petition will be deemed denied, unless an extension of time for 
decision is mutually agreed upon by the appropriate TTB officer and the 
petitioner. TTB may confer with the Food and Drug Administration (FDA) 
on petitions for exemption, as appropriate and as FDA resources permit. 
TTB may require the submission of product samples and other additional 
information in support of a petition; however, unless required by TTB, 
the submission of samples or additional information by the petitioner 
after submission of the petition will be treated as the withdrawal of 
the initial petition and the submission of a new petition. An approval 
or denial under this section will constitute a final agency action.
    (c) Resubmission of a petition. After a petition for exemption is 
denied under this section, the petitioner may resubmit the petition 
along with supporting materials for reconsideration at any time. TTB 
will treat this submission as a new petition for purposes of the time 
frames for decision set forth in paragraph (b) of this section.
    (d) Availability of information. (1) General. TTB will promptly 
post to its public Web site, https://www.ttb.gov, all petitions received 
under this section as well as TTB's responses to those petitions. Any 
information submitted in support of the petition that is not posted to 
the TTB Web site will be available to the public pursuant to 5 U.S.C. 
552, except where a request for confidential treatment is granted under 
paragraph (d)(2) of this section.
    (2) Requests for confidential treatment of business information. A 
person who provides trade secrets or other commercial or financial 
information in connection with a petition for exemption under this 
section may request that TTB give confidential treatment to that 
information. A failure to request confidential treatment at the time 
the information in question is

[[Page 42268]]

submitted to TTB will constitute a waiver of confidential treatment. A 
request for confidential treatment of information under this section 
must conform to the following standards:
    (i) The request must be in writing;
    (ii) The request must clearly identify the information to be kept 
confidential;
    (iii) The request must relate to information that constitutes trade 
secrets or other confidential commercial or financial information 
regarding the business transactions of an interested person, the 
disclosure of which would cause substantial harm to the competitive 
position of that person;
    (iv) The request must set forth the reasons why the information 
should not be disclosed, including the reasons the disclosure of the 
information would prejudice the competitive position of the interested 
person; and
    (v) The request must be supported by a signed statement by the 
interested person, or by an authorized officer or employee of that 
person, certifying that the information in question is a trade secret 
or other confidential commercial or financial information and that the 
information is not already in the public domain.

PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS

0
1. 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.


0
2. A new Sec.  5.32a is added to read as follows:


Sec.  5.32a  Voluntary disclosure of major food allergens.

    (a) Definitions. For purposes of this section the following terms 
have the meanings indicated.
    (1) Major food allergen. Major food allergen means any of the 
following:
    (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, and 
soybeans; or
    (ii) A food ingredient that contains protein derived from a food 
specified in paragraph (a)(1)(i) of this section, except:
    (A) Any highly refined oil derived from a food specified in 
paragraph (a)(1)(i) of this section and any ingredient derived from 
such highly refined oil; or
    (B) A food ingredient that is exempt from major food allergen 
labeling requirements pursuant to a petition for exemption approved by 
the Food and Drug Administration (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.
    (2) Name of the food source from which each major food allergen is 
derived. Name of the food source from which each major food allergen is 
derived means the name of the food as listed in paragraph (a)(1)(i) of 
this section, except that:
    (i) In the case of a tree nut, it means the name of the specific 
type of nut (for example, almonds, pecans, or walnuts);
    (ii) In the case of Crustacean shellfish, it means the name of the 
species of Crustacean shellfish (for example, crab, lobster, or 
shrimp); and
    (iii) The names ``egg'' and ``peanuts'', as well as the names of 
the different types of tree nuts, may be expressed in either the 
singular or plural form, and the term ``soy'', soybean'', or ``soya'' 
may be used instead of ``soybeans''.
    (b) Voluntary labeling standards. Major food allergens (defined in 
paragraph (a)(1) of this section) used in the production of a distilled 
spirit product may, on a voluntary basis, be declared on any label 
affixed to the container. However, if any one major food allergen is 
voluntarily declared, all major food allergens used in production of 
the distilled spirit product, including major food allergens used as 
fining or processing agents, must be declared, except when covered by a 
petition for exemption approved by the appropriate TTB officer under 
Sec.  5.32b. The major food allergens declaration must consist of the 
word ``Contains'' followed by a colon and the name of the food source 
from which each major food allergen is derived (for example, 
``Contains: egg'').
    (c) Cross reference. For mandatory labeling requirements applicable 
to distilled spirits products containing FD&C Yellow No. 5 and 
sulfites, see Sec. Sec.  5.32(b)(5) and (7).

0
3. A new Sec.  5.32b is added to read as follows:


Sec.  5.32b  Petitions for exemption from major food allergen labeling.

    (a) Submission of petition. Any person may petition the appropriate 
TTB officer to exempt a particular product or class of products from 
the labeling requirements of Sec.  5.32a. The burden is on the 
petitioner to provide scientific evidence (including the analytical 
method used to produce the evidence) that demonstrates that the 
finished product or class of products, as derived by the method 
specified in the petition, either:
    (1) Does not cause an allergic response that poses a risk to human 
health; or
    (2) Does not contain allergenic protein derived from one of the 
foods identified in Sec.  5.32a(a)(1)(i), even though a major food 
allergen was used in production.
    (b) Decision on petition. TTB will approve or deny a petition for 
exemption submitted under paragraph (a) of this section in writing 
within 180 days of receipt of the petition. If TTB does not provide a 
written response to the petitioner within that 180-day period, the 
petition will be deemed denied, unless an extension of time for 
decision is mutually agreed upon by the appropriate TTB officer and the 
petitioner. TTB may confer with the Food and Drug Administration (FDA) 
on petitions for exemption, as appropriate and as FDA resources permit. 
TTB may require the submission of product samples and other additional 
information in support of a petition; however, unless required by TTB, 
the submission of samples or additional information by the petitioner 
after submission of the petition will be treated as the withdrawal of 
the initial petition and the submission of a new petition. An approval 
or denial under this section will constitute a final agency action.
    (c) Resubmission of a petition. After a petition for exemption is 
denied under this section, the petitioner may resubmit the petition 
along with supporting materials for reconsideration at any time. TTB 
will treat this submission as a new petition for purposes of the time 
frames for decision set forth in paragraph (b) of this section.
    (d) Availability of information. (1) General. TTB will promptly 
post to its public Web site, https://www.ttb.gov, all petitions received 
under this section as well as TTB's responses to those petitions. Any 
information submitted in support of the petition that is not posted to 
the TTB Web site will be available to the public pursuant to 5 U.S.C. 
552, except where a request for confidential treatment is granted under 
paragraph (d)(2) of this section.
    (2) Requests for confidential treatment of business information. A 
person who provides trade secrets or other commercial or financial 
information in connection with a petition for exemption under this 
section may request that TTB give confidential treatment to that 
information. A failure to request confidential treatment at the ti