FR-Notice of Proposed Rulemaking

Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Proposed Rules
Agency Regulatory Goal
NCUA’s goal is to promulgate clear
and understandable regulations that
impose minimal regulatory burden. We
request your comments on whether the
proposed rule is understandable and
minimally intrusive.
List of Subjects in 12 CFR Part 703
Credit unions, Investments, Reporting
and recordkeeping requirements.
By the National Credit Union
Administration Board on July 20, 2006.
Mary F. Rupp,
Secretary of the Board.

For the reasons set forth in the
preamble, the Board amends 12 CFR
part 703 as set forth below:
PART 703—INVESTMENT AND
DEPOSIT ACTIVITIES
1. The authority citation for part 703
is continues to read:
Authority: 12 U.S.C. 1757(7), 1757(8),
1757(15).

2. Amend § 703.1 by revising
paragraph (b)(2) to read as follows:
§ 703.1

[FR Doc. E6–11908 Filed 7–25–06; 8:45 am]
BILLING CODE 7535–01–P

Purpose and scope.

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*
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*
(b) * * *
(2) The purchase of real estate-secured
loans pursuant to Section 107(15)(A) of
the Act, which is governed by § 701.23
of this chapter, except those real estatesecured loans purchased as a part of an
investment repurchase transaction,
which is governed by §§ 703.13 and
703.14 of this chapter;
*
*
*
*
*
3. Amend § 703.2 by adding the
definition of ‘‘independent qualified
agent’’ alphabetically between the
definitions of ‘‘immediate family
member’’ and ‘‘industry-recognized
information provider’’ to read as
follows:
§ 703.2

Definitions.

*
*
*
*
Independent qualified agent means an
agent independent of an investment
repurchase counterparty that does not
receive a transaction fee from the
counterparty and has at least two years
experience assessing the value of loans.
*
*
*
*
*
4. Amend § 703.14 by adding new
paragraph (h) to read as follows:
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*

§ 703.14

only as a part of an investment
repurchase agreement under § 703.13(c),
subject to the following conditions:
(1) The aggregate of the investments
with any one counterparty is limited to
25 percent of the credit union’s net
worth and 100 percent of its net worth
with all counterparties;
(2) At the time a federal credit union
purchases the securities, the
counterparty cannot have debt with a
long-term rating lower than A¥ or its
equivalent, or a short-term rating lower
than A¥1 or its equivalent;
(3) The federal credit union must
obtain a daily assessment of the market
value of the securities under
§ 703.13(c)(1) using an independent
qualified agent;
(4) The mortgage note repurchase
transaction is limited to a maximum
term of 30 days;
(5) All mortgage note repurchase
transactions will be conducted under
tri-party custodial agreements; and
(6) A federal credit union must obtain
an undivided interest in the securities.

Permissible investments.

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(h) Mortgage note repurchase
transactions. A federal credit union may
invest in securities that are offered and
sold pursuant to section 4(5) of the
Securities Act of 1933, 15 U.S.C. 77d(5),

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DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade
Bureau
27 CFR Parts 4, 5, and 7
[Notice No. 62]
RIN 1513–AB08

Major Food Allergen Labeling for
Wines, Distilled Spirits and Malt
Beverages
Alcohol and Tobacco Tax and
Trade Bureau, Treasury.
ACTION: Notice of proposed rulemaking;
solicitation of comments.
AGENCY:

SUMMARY: In this notice, the Alcohol
and Tobacco Tax and Trade Bureau
proposes the adoption of mandatory
labeling standards for major food
allergens used in the production of
alcohol beverages subject to the labeling
requirements of the Federal Alcohol
Administration Act. The proposed
regulations set forth in this document
also provide procedures for petitioning
for an exemption from allergen labeling.
The proposed regulations parallel the
recent amendments to the Federal Food,
Drug and Cosmetic Act contained in the
Food Allergen Labeling and Consumer
Protection Act of 2004. Under the
proposed regulations, producers,
bottlers, and importers of wines,
distilled spirits, and malt beverages

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must 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, on a product label
unless an exemption applies to the
product in question.
DATES: Comments must be received on
or before September 25, 2006.
ADDRESSES: You may send comments to
any of the following addresses—
• Director, Regulations and Rulings
Division, Alcohol and Tobacco Tax and
Trade Bureau, Attn: Notice No. 62, P.O.
Box 14412, Washington, DC 20044–
4412.
• 202–927–8525 (facsimile).
• nprm@ttb.gov (e-mail).
• http://www.ttb.gov/alcohol/rules/
index.htm. An online comment form is
posted with this notice on our Web site.
• http://www.regulations.gov. Federal
e-rulemaking portal; follow instructions
for submitting comments.
You may view copies of any
comments we receive about this notice
by appointment at the TTB Information
Resource Center, 1310 G Street, NW.,
Washington, DC 20220. To make an
appointment, call 202–927–2400. You
may also access copies of this notice
and any comments online at http://
www.ttb.gov/alcohol/rules/index.htm.
See the Public Participation section of
this notice for specific instructions and
requirements for submitting comments,
and for information on how to request
a public hearing.
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
eight major food allergens in plain,
common language on the food and
beverage products 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.

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Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Proposed Rules

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
‘‘table’’ wine or ‘‘light’’ wine (see 27
CFR 4.36(a)). In addition, labels must
note the presence of sulfites, FD&C
Yellow No. 5, and in the case of malt

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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

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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

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Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Proposed Rules
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 and beverage
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
Act and for ensuring that the nation’s
food supply is properly labeled. FDA’s
responsibility for proper labeling of food
applies to most domestic and imported
food and beverage products. However, it

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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 BrownForman 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

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report, TTB consulted with FDA prior to
issuing this proposed rule. However, it
should be emphasized that while we
have proposed this rule in response to,
among other things, the expectations set
out in the legislative history of FALCPA,
TTB’s legal authority to issue
regulations on allergen labeling of
alcohol beverages 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 proposed rule
reflects TTB’s interpretation of its
authority under the FAA Act, as guided
by the language in the committee report.
The proposed regulations do not
necessarily represent the views of FDA
with regard to allergen labeling or the
requirements of FALCPA.
II. Rulemaking History and Discussion
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

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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
ANRPM 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
(hereafter referred to as ‘‘the trade
associations’ consolidated comment’’),
in which they stated that they fully
supported the purpose and objectives of

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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.
The comments we received in
response to Notice No. 41 on allergen
issues are discussed in more detail
below.
A. Comments on Industry Costs Versus
Consumer Benefits
In the ANPRM we asked for
comments on the issue of what costs
mandatory allergen labeling would

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impose on the industry and, ultimately,
the consumer. We also solicited
comments on how consumers might
benefit from allergen labeling.
Costs
Only a few comments specifically
addressed the issue of costs and
benefits. Some commenters assumed
that any costs associated with
mandatory labeling arise from the
enactment of FALCPA and the
expression of congressional intent
regarding allergen labeling of alcohol
beverages and that the cost issue was
therefore not open for discussion. For
example, the trade associations’
consolidated comment responded to our
solicitation of comments on the cost
issue by stating that ‘‘[m]andatory
allergen labeling requirements pursuant
to the Food Allergen Labeling and
Consumer Protection Act were signed
into law by the President in August
2004.’’ The consolidated comment did
not include any estimates of the costs
associated with the relabeling of alcohol
beverages or with the potential
reformulation of such products to avoid
allergen labeling.
A few commenters raised general
concerns about the costs of allergen
labeling, based on their assumption that
small wineries would be required to
conduct expensive laboratory analyses
to determine allergen content. For
example, Grove Winery commented in
opposition to any additional mandatory
labeling requirements, including
allergen labeling. The winery stated that
the ‘‘laboratory work required for each
lot would be a prohibitive cost for small
lots and for small family wineries,
making it even more difficult to
compete with the large wine
conglomerates and low cost imports.’’
We received three other comments
raising similar concerns about the costs
of testing wines for allergens, and the
potential impact of such costs on small
wineries.
On the other hand, Dr. Rogers
suggested that the least costly approach
for the manufacturer, and the safest for
the allergic consumer, would be for the
producer to list all allergens used in
production. She suggested that this
approach would preclude the need for
testing, and the disclosure of the
presence of an allergen would allow the
allergic consumer to make an informed
decision.
CSPI and one individual commenter
referenced a past cost assessment done
by FDA that evaluated relabeling costs
for a final rule adding trans fatty acid
labeling requirements to foods (see 68
FR 41434, 41477, July 11, 2003). In the
study, FDA estimated that the average

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low relabeling cost per ‘‘stock keeping
unit’’ (SKU) would be about $1,100 and
the average high relabeling cost per SKU
would be $2,600. An SKU is a specific
product sold in a specific size.
CSPI and the individual commenter
applied these FDA relabeling cost
estimates to the alcohol beverage
labeling changes aired for comment in
the ANPRM. Applying the estimates to
a winery selling 5 types of wine, they
computed the average total cost of
relabeling to be between $5,500 and
$13,000 for the winery. They then
applied the estimates to a particular
brand of wine, stating that if the winery
produced 320,000 9-liter cases
(3,840,000 750 ml bottles), ‘‘[e]ach of
those bottles would incur a cost of
$0.000677—less than 7/100ths of a
penny—if the cost were $2,600 per
sku.’’
The Brewers Association did a survey
of its members to find out what costs
brewers might incur from the new
labeling proposals at issue in the
ANPRM. The comment stated that the
aggregate average costs for respondents
by size ranged from $35,530 per brewer
for smaller brewers to $1.5 million per
brewer for larger brewers. However, it is
noteworthy that these estimates were
used to support the Brewers
Association’s opposition to various
proposals for new mandatory labeling
requirements in the advance notice,
including ingredient labeling,
nutritional labeling, and ‘‘Alcohol
Facts’’ panels. Moreover, while the
Brewers Association opposed most of
the new mandatory labeling
requirements aired for comment in the
ANPRM and requested exemptions for
small brewers from most new labeling
requirements, the association’s
comment supported mandatory allergen
labeling, where allergens are present at
levels proven to be harmful to certain
consumers, and did not request that
small brewers be exempted from
mandatory allergen labeling.
One commenter who identified
himself as a consumer stated that the
costs of mandatory labeling would far
outweigh any consumer benefits. He
suggested that TTB set guidelines for
voluntary allergen labeling, rather than
mandatory requirements.
Consumer Benefits
We received several comments that
addressed the potential benefits to
consumers if TTB required mandatory
allergen labeling on alcohol beverages.
For example, in her comment, Dr.
Rogers described the costs associated
with the health risks that the major food
allergens pose. She stated, ‘‘Currently, a
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allergic public who suffer 4–6 hours of
debilitating illness as a result of allergic
reactions from hidden or unknown
ingredients. There are also economic
costs as a result of medications and
emergency room visits associated with
these incidents.’’ Many other
commenters agreed that allergen
labeling requirements provide distinct
benefits to consumers, including
providing critical information for
consumers with potentially deadly food
allergies.
Several commenters noted that
mandatory labeling requirements for
major food allergens allow consumers to
make informed decisions. Dr. Rogers, for
example, stated:
Currently, besides abstinence, the only way
to determine if allergens are present in
alcoholic beverages is to either contact the
brewer/distiller directly for each bottle
consumed, or to engage in the more usual
high-risk behavior of ‘‘trial and error.’’ The
latter approach is complicated by the fact
that the onset of an allergic reaction can be
similar to or be obscured by the effects of
alcohol ([for example], generalized flushing,
lightheadedness).

A consumer explained that some
beverages have caused her to break out
in a mild rash, and she feels that
knowing what ingredients are present in
these beverages would help her know
what drinks to avoid. A Canadian
consumer commented that she has an
anaphylactic allergy to eggs, and she
stated that she considers it very
dangerous to drink alcohol beverages at
all due to the fact that no allergen
information is currently identified on
alcohol beverages.
A comment from the American
Academy of Allergy, Asthma and
Immunology, the American College of
Allergy, Asthma and Immunology, and
the Food Allergy and Anaphylaxis
Network explained the risks of food
allergy anaphylaxis as follows:
As you may know, food allergy is an
increasing public health and food safety
issue. A fish and shellfish prevalence study
showed approximately 6.6 million
Americans reporting an allergy to these
foods. Combined with a previous study of the
prevalence of peanut and tree nut allergy, we
now estimate that approximately 11.4 million
Americans, or 4% of the population, have a
food allergy. This represents a significant
increase from estimates just 10 years ago,
when scientists believed that food allergy
affected less than 1% of the population.
Food-allergic reactions continue to be the
leading cause of anaphylaxis (a severe,
potentially life-threatening allergic reaction)
outside the hospital setting, accounting for an
estimated 30,000 emergency room visits,
2,000 hospitalizations, and 150–200 deaths
each year in the U.S. alone. (Footnotes
omitted.)

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This comment also stated that there
was currently one research study in the
medical literature showing an
anaphylactic reaction caused by a major
food allergen in an alcohol beverage
(wheat beer), and that there were
anecdotal reports of reactions from other
allergens (such as eggs) in alcohol
beverages.
TTB Response
The majority of the commenters who
addressed this issue agreed with the
congressional findings on the
importance of providing consumers
with clear information about the
presence of major food allergens in
foods and beverages. We agree with
those commenters who stated that
mandatory labeling of the major food
allergens provides critical information
for individuals with potentially deadly
food allergies, allowing those consumers
to make informed decisions.
In response to the concerns expressed
by some wineries that they would be
required to conduct extensive and
expensive laboratory analysis to
determine allergen content, we note that
mandatory allergen labeling does not
necessarily require producers to
conduct any chemical analyses of their
products. Producers are aware of and
usually keep extensive records of what
materials, including major food
allergens, go into the production of an
alcohol beverage. The producers
therefore would already know when the
presence of a major food allergen ought
to be declared. Thus, the adoption of
mandatory labeling requirements for
major food allergens in alcohol
beverages would not require expensive
laboratory tests of those alcohol
beverages.
Because small producers would not
have to engage in laboratory testing of
their products in order to comply with
mandatory allergen labeling
requirements, we do not believe that
small businesses would be adversely
impacted by such requirements. In any
event, we believe that exempting small
producers from allergen labeling
requirements would be inconsistent
with our statutory mandate under the
FAA Act to protect the consumer and
ensure that alcohol beverage labels
provide the consumer with adequate
information about the identity of the
product. Furthermore, the House
committee report that directed TTB to
work with FDA to implement allergen
labeling for alcohol beverages stated that
‘‘[s]ince there is currently no cure for
food allergies, consumers need to be
empowered to know whether or not
food allergies are present in the food
they consume.’’ This clear congressional

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concern would not be addressed by a
rule that allowed for exemptions for
small producers.
In this notice, we are soliciting
comments directed specifically to the
costs and benefits of mandatory labeling
of major food allergens and on ways to
reduce the costs to industry, in
particular small businesses. We note
that the regulatory texts in this proposed
rule do not specifically require
laboratory tests. Nevertheless, any
business that believes it would be
adversely impacted by the proposed
rule should provide us with specific
cost figures. We also are soliciting
comments on any alternative approach
that would meet the intent of FALCPA
while minimizing the costs imposed on
industry members. We are also seeking
comments on how much time industry
requires to comply with such labeling
requirements. These issues will be
carefully considered in the formulation
of a final rule on allergen labeling.
B. Comments on Requiring a Full List of
Ingredients
In the ANPRM we asked whether TTB
should require that major food allergen
labeling on alcohol beverage containers
be part of, or adjacent to, a larger list of
all ingredients found in the product,
similar to the requirements of the FD&C
Act as amended by FALCPA.
Several commenters expressed
support for mandatory ingredient
labeling that would include allergenic
ingredients. Dr. Rogers, for example,
noted that the major food allergens do
not account for all allergic reactions,
and she suggested that complete
ingredient labeling was important for
the following reason:

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Although milk, egg, fish, shellfish, tree
nuts, peanuts, wheat and soy account for
most of the food allergy reactions, there are
still a significant number of reactions to other
proteins not in this list. Therefore a
comprehensive ingredient listing would
provide the most useful information to
allergic individuals regardless of the
particular allergen.

The NCL also supported requiring a
full list of ingredients, stating that such
a requirement would create labeling
consistency between those alcohol
beverage products regulated by TTB and
wines that are under 7 percent alcohol
by volume, the labeling of which is
regulated by FDA. The NCL further
asserted that Americans with food
allergies are accustomed to looking at a
product’s ingredient declarations to see
whether the product contains the
allergen they must avoid.
Many industry commenters, on the
other hand, suggested that while major
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important information to a consumer, a
full ingredient disclosure has the
potential to mislead consumers. For
example, the trade associations’
consolidated comment stated that a
substantial transformation of the raw
materials takes place during the
fermentation and distillation process in
the production of alcohol beverages.
The comment asserted that this
transformation means that there is little,
if any, relationship between the initial
ingredients and the contents of the
finished product, which undermines the
usefulness of ingredient labeling.
TTB Response
As noted above, ATF explored the
issue of requiring a full list of
ingredients on several occasions in the
past and found it to be a very
controversial and complex issue. Based
on our preliminary review of all
comments received in response to the
ANPRM, we recognize that the issue of
ingredient labeling remains a
controversial subject. In contrast, most
of the comments we received in
response to the issue of allergen
labeling, including those of industry
members, favored allergen labeling. In
view of the controversy and complexity
surrounding the complete ingredient
labeling issue, we have determined that
broader ingredient labeling should not
be included with our rulemaking on
major food allergen labeling. We are
deferring consideration of broader
ingredient labeling for a later, additional
rulemaking.
C. Comments on Labeling When the
Allergen Appears as Part of a Brand
Name
In the ANPRM, we posed the
following question:
If the product name appearing on the label
of an alcohol beverage container indicates
that an allergen is present in the product, is
it helpful to the consumer to have the
allergen labeled again in a standardized
allergen statement elsewhere on the
container? To illustrate: if a product is called
‘‘Wheat Beer,’’ should it also have a label
elsewhere on the container that reads:
‘‘Allergens: wheat’’? Why or why not?

We received several comments on this
issue. Many commenters stated that it is
unnecessary to label a product with a
second allergen label if the allergen is
listed elsewhere on the label, for
example, if it is included in the brand
name or product name. The European
Spirits Organisation argued that we
should be consistent with the European
Union approach to this problem, where
a separate allergen labeling declaration
is not required if the allergen present in
the final product is identified in the

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product name or elsewhere on the label.
They suggested that it should be
sufficient for the allergen to appear in
the product name.
On the other hand, the Ketel One
Vodka company commented that
regardless of whether the product name
indicates that an allergen is present, the
label should properly disclose any
major food allergen in a standardized
form. Dr. Rogers also suggested that one
section of the labeling should be the
reliable source of ingredient and
allergen information.
TTB Response
We think that some measure of
standardization is necessary, and
therefore it would be inappropriate to
allow an allergen to be listed only in an
alcohol beverage product’s brand or
product name. We believe it is
reasonable to assume that consumers
would grow accustomed to seeing
allergen information in one format on
alcohol beverage labels and would look
for that format.
Moreover, we think that a consumer
could be misled if a brand name
contains the allergen name, but does not
also list the allergen in the same
standard format as is required for an
alcohol beverage that does not mention
the allergen in its brand name. We also
can foresee a situation where the brand
name of a product includes a major food
allergen, but the major food allergen is
not present in the final product. To
illustrate, consider two hypothetical
products:
1. A beer made by Wheat Creek
Brewery called ‘‘Wheat Creek Lager,’’
which does not contain wheat; and
2. A wheat beer called ‘‘Creek’s Wheat
Beer,’’ which does contain wheat
protein.
While ‘‘wheat beer’’ is in fact brewed
in part from wheat, the use of the term
‘‘wheat’’ in the above examples does not
necessarily signify the presence of
wheat in the product. Therefore, if we
adopted a rule that did not require
disclosure of allergens where the
allergen was included in the brand
name of the product, consumers could
not be sure when the brand name is in
fact imparting information about the
presence of an allergen. The consumer
should not have to guess in the above
situations whether the product does in
fact contain wheat or protein derived
from wheat. Instead, consumers should
be able to look at the label and
determine right away whether the
product contains any of the major food
allergens, and if so, which ones.
To avoid any potential confusion as to
what allergen proteins the product may
or may not contain, we believe that the

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best policy is to require disclosure of
major food allergens in one standard
format, whether or not the brand name
or any other part of a product label
includes the name of the allergen.
D. Comments Regarding the Labeling of
Processing and Fining Agents
In the ANPRM, we posed a number of
questions regarding the labeling of
processing or fining aids containing
allergens.
In response to these questions, a few
commenters expressed opposition to
required labeling of allergenic
processing or fining agents, arguing that
there is a lack of clinical evidence that
the trace amounts of allergenic fining
agents in wine are harmful. For
example, Kendall-Jackson Wine Estates
asserted that the fining agents used in
wine (such as egg whites and isinglass)
are substantially altered during the
production process. This comment
stated that the tertiary structure of the
molecule is changed and precipitated
out, making it virtually impossible for
an adverse reaction to occur.
An individual who commented as
both a parent and a wine chemist stated
that he agreed with listing allergens that
are added to the wine as part of the
formula, but stated that processing aids,
such as sodium casein, should not be
required to be listed unless evidence
establishes that they remain in the wine.
He also noted that wine makers use
different processing aids every year
depending on the wines, and asked
whether such wineries would be able to
list the processing aid on a label as, for
example, ‘‘sodium casein may have
been used in clarifying this wine.’’
In contrast, many other commenters
suggested that it was important to label
fining and processing agents. For
example, CSPI commented that if not
subject to an exemption, consumers will
expect fining, processing, and filtering
agents to be labeled in the same way as
any other major food allergen is labeled
under FALCPA. CSPI further noted that
under exemption procedures in
FALCPA, the burden is on the
manufacturer to present scientific
evidence that justifies a labeling
exemption for a major food allergen that
is present in very small amounts. CSPI
suggested that we should adopt the
same exemption procedures in our
regulations and that, unless such fining
or processing agents are officially
exempted, labeling of these agents
should be required.
Dr. Elizabeth TePas, a medical
researcher at Massachusetts General
Hospital, also stressed the importance of
the labeling of fining and processing
agents. She stated, ‘‘While most food

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allergic individuals are not going to
react to the minute amounts of allergen
found in some alcoholic beverages,
those who are extremely sensitive can
have life-threatening reactions.’’ She
suggested that until thresholds are
scientifically established and affordable
and reliable testing is available, both
allergens used as primary ingredients
and allergens used as fining and
processing agents should be disclosed
on the label.
Several other commenters also
supported the assertion that individuals
can possibly have an adverse reaction to
mere traces of an allergen. For example,
a comment from the American Academy
of Allergy, Asthma & Immunology, the
American College of Allergy, Asthma &
Immunology, and the Food Allergy &
Anaphylaxis Network stated that
ingestion of even small amounts of an
allergen can elicit adverse reactions.
While a few industry members
commented that fining and processing
agents are not present in finished
products, other industry commenters
acknowledged that wine treated with
fining and processing agents may
contain trace amounts of those fining
agents in the final product. For example,
the Winemakers Federation of Australia
advised that most processing aids, if
used and removed according to good
manufacturing practice, will leave
negligible residual in the final product.
This comment also stated that in
Australia, processing aids must be
labeled unless they cannot be detected
in the final product. The California
Association of Winegrape Growers also
noted in its comment that wine may
contain trace amounts of some fining
and filtering aids that were used in
production, although the comment
opposed a requirement to label such
trace amounts in the absence of
threshold level guidance from FDA.
Dr. Rogers and Dr. TePas both
supported the labeling of fining agents.
However, they both commented that it
would be helpful for consumers of
alcohol beverages to have a way to
differentiate between those allergens
used as primary ingredients (and
therefore present at higher
concentrations in the finished product)
and those allergens used as fining or
processing aids (and therefore present at
lower concentrations in the finished
product).
However, Dr. Rogers, the European
Spirits Organisation, and the trade
associations’ consolidated comment
noted that it is important for consumers
to trust that the allergen labeling
information on labels is reliable. Dr.
Rogers, for example, stated, ‘‘An
indication that a particular beverage

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‘may contain egg protein’ potentially
complicates the issue. It leaves the
question open as to whether the allergen
is or is not in the beverage.’’ She further
indicated that such statements may be
ignored by consumers based upon prior
experience consuming the food product
in question without incident. The trade
associations’ consolidated comment
similarly stated: ‘‘Consumers need to
trust that the allergen labeling
information is reliable and not be
subjected to precautionary statements
where the statement will be ignored
based upon, for example, prior
experience consuming the food product
in question.’’
TTB Response
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). Accordingly, the
proposed rule treats 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.
In response to one commenter’s
assertion that fining agents are
substantially altered during the
production process, making it virtually
impossible for an adverse reaction to
occur, we have seen no scientific or
clinical evidence that supports the
assertion that an adverse reaction is
‘‘virtually impossible.’’ We welcome the
submission of any such evidence as part
of this rulemaking.
In response to the comments on
different labeling for fining and
processing aids, we are proposing that
fining and processing aids be labeled in
the same way as any other major food
allergens used in the production of an
alcohol beverage. However, we are
specifically soliciting comments on
whether fining and processing aids
should be labeled with a different
statement, for example, ‘‘processed
with’’ instead of ‘‘contains.’’
One commenter asked whether TTB
would allow a winery to use a ‘‘may
contain’’ label for processing aids, given
the fact that a winery may use different
processing aids every year for different
wines. We believe using a ‘‘may
contain’’ statement for fining or
processing aids that were intentionally
added to a product would be unclear
and misleading. Instead, the label
should clearly indicate what processing

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aids containing major food allergens
were actually used in production of the
alcohol beverage. It is the producer’s
obligation to know what processing aids
were used for particular products.

which they are sensitized, which could
impact the NOAEL and LOAEL. Dr.
Rogers also stated that some
components of alcohol beverages can
heighten the allergic response.

E. Comments Regarding the Setting of
Thresholds for Each Major Food
Allergen
In the ANPRM, we asked several
questions regarding the setting of
threshold levels for each of the major
food allergens.
Several industry commenters
suggested that additional study is
required to establish threshold levels
before TTB requires the labeling of
major food allergens, particularly
allergens used as fining agents or other
processing aids. For example, Ketel One
Vodka argued that additional study is
required to ascertain how the various
levels of major food allergens may affect
alcohol beverage consumers, and only
once threshold levels are established
should producers of alcohol beverages
be required to disclose the presence of
major food allergens. The California
Association of Winegrape Growers also
commented that it would be premature
for TTB to take any action on allergen
labeling until FDA establishes
thresholds or provides guidance for the
labeling of processing aids based on
scientifically meaningful data.
CSPI, however, noted in its comment
that in enacting FALCPA, Congress
recognized that thresholds for the eight
major food allergens had not yet been
established by the scientific community.
CSPI noted that Congress also rejected
an automatic exemption for allergens
that may be present in very small
amounts. See House committee report at
17 and the Senate Committee on Health,
Education, Labor, and Pensions report
on FALCPA, S. Rep. No. 226, 108th
Cong., 2d Sess., at 7 (2004) (hereafter the
Senate committee report).
Two medical researchers also noted
the lack of threshold data for the major
food allergens. Dr. TePas explained in
her comments that ‘‘while there is some
data available on the lowest observed
adverse effect level (LOAEL) for the
major food allergens, data on nonobserved adverse effect levels (NOAEL)
is scant to absent.’’ Dr. Rogers also noted
that no scientific consensus on ‘‘safe’’
threshold levels currently exists. Her
comment suggested that it is not
possible to define a minimum threshold
that would assure the most sensitive
individuals that a reaction would not
occur.
Additionally, Dr. TePas suggested that
alcohol may lower the threshold for
having a reaction when an allergic
individual is exposed to an allergen to

TTB Response

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FALCPA amends the FD&C Act to
require that, notwithstanding any other
provision of law, all flavoring, coloring,
or incidental additives that bear or
contain a major food allergen must be
labeled. See 21 U.S.C. 343(w)(4), as
amended. 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
proposed regulations provide 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.
Accordingly, TTB is not proposing to set
thresholds in this notice of proposed
rulemaking.
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.
F. Comments on Harmonization With
Foreign Government Requirements and
With Other Federal Agency
Requirements
In addition to the specific questions
on allergen labeling in the ANPRM, we
asked broad questions related to all
labeling changes at issue. One of those
questions was whether TTB should
harmonize its labeling requirements
with those of other major producing
nations such as the Member States of
the European Union (EU), Australia, and
Canada, and with the regulatory
schemes of other Federal agencies such
as FDA. We also asked how such
harmonization would be best achieved.
In response to this question, most
commenters who addressed this issue,
including industry members and
consumer advocates, suggested that we
should be consistent with FDA on
allergen labeling requirements and
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The trade associations’ consolidated
comment urged us to work in tandem
with FDA to implement allergen
labeling requirements for alcohol
beverages in a manner that meets the
objectives of Congress. The consolidated
comment also encouraged TTB to pay
‘‘due regard to the actions taken by the
[EU] regarding what products do or do
not require labeling under the EU
Allergen Directive (2003/89/EC).’’
On November 25, 2003, the European
Commission amended the rules
regarding labeling of foodstuffs
(including alcohol beverages) to require
the mandatory labeling of specified food
allergens. The allergens subject to this
directive are cereals containing gluten,
Crustacean shellfish, eggs, fish, peanuts,
soybeans, milk, tree nuts, celery,
mustard, sesame seeds, and sulphites at
concentrations of more than 10 mg/kg.
See Directive 2003/89/EC, amending
Directive 2000/13/EC.
In the amendments, the Commission
provided an avenue for provisional
exclusion of particular ingredients and
substances derived from allergens to
allow manufacturers or their
associations to conduct scientific
studies to establish that those
ingredients or products are not likely,
under specific circumstances, to trigger
adverse reactions. The Commission,
after receiving notice of several
scientific studies and after consultation
with the European Food Safety
Authority, provisionally excluded eight
uses of major food allergens in alcohol
beverages until November 25, 2007. See
Commission Directive 2005/26/EC.
These eight uses are:
1. Distillates made from cereals
containing gluten;
2. Distillates made from whey (milk);
3. Distillates made from nuts;
4. Lysozyme (egg) used in wine;
5. Albumen (egg white) used as a
fining agent in wine and cider;
6. Fish gelatin or Isinglass used as a
fining agent in beer, cider, or wine;
7. Milk (casein) products used as
fining agents in cider and wines; and
8. Nuts used as flavor in spirits.
In their consolidated comment, the
major U.S. alcohol beverage industry
trade associations urged TTB to ‘‘follow
the approach taken by the EU that
excludes categories of products that are
produced and/or processed in a similar
manner, i.e. the exclusions from the
allergen labeling requirement are linked
to the specific methods of manufacture
and/or uses identified in the
documentation supporting the
exclusions.’’

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TTB Response

A. Labeling of Major Food Allergens

The proposed rule is generally
consistent with the requirements of
FALCPA, although, as noted in this
document, there are certain areas in
which we have proposed to provide for
different rules applicable to the labeling
of major food allergens used in the
production of alcohol beverages. TTB is
not proposing a provisional exclusion
for any ingredients or substances at this
time. We do, however, agree that any
exemptions from allergen labeling
should apply to categories of products
that are produced in an identical
manner, and the proposed regulations
so provide.

1. Definitions
Consistent with the FALCPA
amendments, the proposed regulations
provide that when allergen labeling is
required on an alcohol beverage
product, 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 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, 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 proposed 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.

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III. Proposed Regulatory Changes
After careful consideration of the
comments received on allergen issues in
response to the ANPRM, 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 with 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.
The proposed regulatory changes set
forth in this document would amend
parts 4, 5, and 7 of the TTB regulations
to set forth requirements for mandatory
labeling of major food allergens. These
changes include the addition of a new
paragraph (d) in § 4.32, a new paragraph
(b)(6) in § 5.32, and a new paragraph
(b)(5) in § 7.22. These sections list
mandatory label information for alcohol
beverage products, and the added texts
in each case direct the reader to a new
section added to part 4, 5, or 7. These
new sections, §§ 4.32a, 5.32a, and 7.22a,
set forth specific, detailed requirements
for major food allergen labeling of
wines, distilled spirits, and malt
beverages, respectively. Finally, we
propose to add three new sections,
§§ 4.32b, 5.32b, and 7.22b, to set forth
procedures for the submission and
approval of petitions for exemption
from the new major food allergen
labeling requirements. A detailed
discussion of the specific proposed
regulatory amendments follows.

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2. Labeling of Fish Species
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). 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 proposed 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 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.

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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 ‘‘nonnutritive 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 the FALCPA
amendments require 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.

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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).
As previously explained, the FDA
regulations define the term ‘‘incidental
additive’’ to include, among other
things, processing aids. See 21 CFR
101.100(a)(3). Therefore, the proposed
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 an
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
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.
Accordingly, TTB is not proposing to set
thresholds.
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.

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B. Exceptions From Allergen Labeling
Requirements
The proposed 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

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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
proposed 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,

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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 proposed 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
would have to consider two issues when
determining whether an ingredient
exempted under the FD&C Act is also
not subject to TTB allergen labeling
requirements under TTB’s proposed
regulations. 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, proposed 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, under the proposed
regulations, 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 would have to
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
under the proposed regulations 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

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Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Proposed Rules
products instead of ingredients. The
TTB petition process could 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 proposed 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 90day notice procedure similar to the
notification procedure in subsection
(w)(7) of the statute. The proposed
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 proposed 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 would be submitted, if
the regulations are adopted, is the
Assistant Administrator, Headquarters
Operations. Petitions 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.
In addition, the proposed 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 proposal of
mandatory allergen labeling regulations,

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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 the proposed rule.
Consistent with FALCPA, the
proposed 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 proposed
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 proposed regulations
provide that petitions submitted to TTB,
and TTB’s response to those petitions,
will be posted to the TTB Web site
(http://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 would be able to
request that TTB give confidential
treatment to that information. The
proposed regulations set forth the
standards for making such a request. A

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failure to request confidential treatment
at the time the information in question
is submitted to TTB would constitute a
waiver of confidential treatment.
C. Effective Date and Compliance With
the Proposed Regulations
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.
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, we are issuing
this notice in order to solicit comments
on our proposed rules regarding
mandatory allergen labeling of alcohol
beverage products.
However, we have issued interim
regulations to govern the voluntary
labeling of major food allergens in
alcohol beverage products and
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.
These interim regulations, which are
effective immediately, are published in
the Rules and Regulations section of this
Federal Register.
Several industry commenters
suggested that we follow the compliance
date approach taken in the sulfite
labeling rulemaking. See T.D. ATF–236
(September 30, 1986, 51 FR 34706), in
which ATF applied the dates for
compliance in a three-step fashion over
a one year period. However, for labeling
of major food allergens, we believe a
three-step compliance standard
modeled after the sulfite rulemaking is
not necessary. We believe that providing
one delayed date for compliance, rather
than three dates, would be easier to
administer and would facilitate industry
compliance. However, we are soliciting
specific comments on what period of

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time industry needs to comply with
allergen labeling requirements.
Although the proposed regulatory
texts do not specifically address this
issue, we anticipate that TTB would not
require an industry member to apply for
a new COLA for a product before adding
major food allergen declarations to the
label. We believe this policy would
foster compliance and ease
administrative burdens. Under such a
policy, a COLA valid at the time the
final rule went into effect would not
become invalid because of the new
regulatory texts. However, industry
members may apply for new COLAs if
they wish. They also would have an
opportunity to obtain guidance from
TTB on how to add these additional
allergen statements to their labels.
IV. Public Participation

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Comments Sought
We request comments from anyone
interested in the proposed mandatory
allergen labeling regulations set forth in
this document. All comments must
reference Notice No. 62 and include
your name and mailing address. They
must be legible and written in language
acceptable for public disclosure.
Although we do not acknowledge
receipt, we will consider your
comments if we receive them on or
before the closing date. We regard all
comments as originals.
We are specifically soliciting
comments on the following issues:
1. What would be the costs associated
with mandatory allergen labeling to the
industry and, ultimately, the consumer?
2. Does the proposed rule adversely
impact small businesses? If so, explain
how. If you are a small business and you
expect that the proposed rule would
have an adverse impact on you, please
provide us with specific data on the
expected adverse impact.
3. Are there ways in which the
proposed regulations can be modified to
reduce the regulatory burdens and
associated costs imposed on the
industry?
4. The proposed rule allows industry
members a great deal of flexibility in the
placement of mandatory allergen
labeling statements. Does this flexibility
reduce the costs of compliance? Would
this flexibility interfere with the
consumer’s ability to locate the allergen
declaration? Alternatively, should TTB
mandate specific placement, type size,
and presentation requirements for these
labeling statements in addition to the
requirements already applicable to all
mandatory information on alcohol
beverage labels? For example, should
the required allergen disclosure

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statement be set off by a box? Should
the statement of major food allergens be
combined with existing required
disclosures of FD&C Yellow No. 5,
sulfites, and aspartame?
5. Do the proposed rules provide
adequate information to consumers
about the use of fining or processing
agents? Should processing or fining
agents be subject to a different labeling
requirement, for example, a ‘‘processed
with’’ labeling statement instead of a
‘‘contains’’ labeling statement? Would
requiring a distinction between primary
ingredients and fining and processing
agents be informative to the consumer
or would it mislead consumers? Would
distinct labeling for processing and
fining agents allow industry members to
impart more specific information about
the use of processing and fining aids?
6. Should mandatory allergen labeling
statements for alcohol beverages
disclose the specific species of fish, or
is it sufficient to merely label the
allergen as ‘‘fish,’’ as TTB proposes?
7. How much time does industry
require to comply with mandatory food
allergen labeling requirements? What
delayed effective date would reduce the
regulatory burdens on affected industry
members and at the same time ensure
the protection of consumers?
Confidentiality
All comments are part of the public
record and subject to disclosure. Do not
enclose any material in your comments
that you consider confidential or
inappropriate for public disclosure.
Submitting Comments
You may submit comments in any of
five ways:
• Mail: You may send written
comments to TTB at the address listed
in the ADDRESSES section of this
document.
• Facsimile: You may submit
comments by facsimile transmission to
202–927–8525. Faxed comments must—
(1) Be on 8.5- by 11-inch paper;
(2) Contain a legible, written
signature; and
(3) Be no more than five pages long.
This limitation ensures electronic access
to our equipment. We will not accept
faxed comments that exceed five pages.
• E-mail: You may e-mail comments
to nprm@ttb.gov. Comments transmitted
by electronic mail must—
(1) Contain your e-mail address;
(2) Reference Notice No. 62 on the
subject line; and
(3) Be legible when printed on 8.5- by
11-inch paper.
• Online form: We provide a
comment form with the online copy of
this document on our Web site at http://

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www.ttb.gov/alcohol/rules/index.htm.
Select the ‘‘Send comments via e-mail’’
link under Notice No. 62.
• Federal e-Rulemaking Portal: To
submit comments to us via the Federal
e-rulemaking portal, visit http://
www.regulations.gov and follow the
instructions for submitting comments.
You may also write to the
Administrator before the comment
closing date to ask for a public hearing.
The Administrator reserves the right to
determine whether to hold a public
hearing.
V. Public Disclosure
You may view copies of this proposed
rule document and any comments we
receive by appointment at the TTB
Information Resource Center at 1310 G
Street, NW., Washington, DC 20220.
You may also obtain copies at 20 cents
per 8.5- x 11-inch page. Contact our
information specialist at the above
address or by telephone at 202–927–
2400 to schedule an appointment or to
request copies of comments.
We will post this document and any
comments we receive on the TTB Web
site. All name and address information
submitted with comments, including email addresses, will be posted. We may
omit voluminous attachments or
material that we consider unsuitable for
posting. In all cases, the full comment
will be available in the TTB Information
Resource Center. To access the online
copy of this document and the
submitted comments, visit http://
www.ttb.gov/alcohol/rules/index.htm.
Select the ‘‘View Comments’’ link under
this document’s number and title to
view the posted comments.
VI. Regulatory Analysis and Notices
A. Executive Order 12866
We have determined that this
proposed rule is not a significant
regulatory action as defined in
Executive Order 12866. Therefore, a
regulatory assessment is not required.
B. Regulatory Flexibility Act
We certify under the provisions of
section 3 of the Regulatory Flexibility
Act (5 U.S.C. 605(b)) that this proposed
rule will not have a significant
economic impact on a substantial
number of small entities. Based on the
comments we received in response to
the advance notice of proposed
rulemaking, we believe that 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

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secondary or incidental effects on a
substantial number of small entities.
We specifically solicit 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. We ask any small
business that believes that it would be
significantly affected by this proposed
rule to let us know and to tell us how
the rule would affect it.

agency’s estimate of the information
collection burden; (c) ways to enhance
the quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the information collection
burden on respondents, including
through the use of automated collection
techniques or other forms of information
technology; and (e) estimate of capital or
start up costs and costs of operations,
maintenance, and purchase of services
to provide information.

C. Paperwork Reduction Act
This proposed rule includes a new
collection of information involving the
mandatory declaration of major food
allergens on a front or back label and the
voluntary submission of petitions for
exemption from allergen rulemaking.
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 collection of information is in
§§ 4.32, 4.32a, 4.32b, 5.32, 5.32a, 5.32b,
7.22, 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: 3,700
hours.
• Estimated average annual burden
per respondent/recordkeeper: 0.74
hours.
• Estimated number of respondents
and/or recordkeepers: 5,000.
• Estimated annual number of
responses: 5,020.
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 by any of the
methods previously described.
Comments should be submitted within
the time frame that comments are due
regarding the substance of the
regulation.
Comments are invited on: (a) Whether
the collections of information are
necessary for the proper performance of
the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the

VII. Drafting Information

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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
For the reasons discussed in the
preamble, TTB proposes to amend 27
CFR parts 4, 5, and 7 as follows:
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.

2. In § 4.32, paragraph (d), which is
currently reserved, is added to read as
follows:
§ 4.32

Mandatory label information.

*

*
*
*
*
(d) If a major food allergen as defined
in § 4.32a is used in the production of
a wine, there shall be included on a
label affixed to the container a statement
as required by that section.
*
*
*
*
*

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42341

3. Section 4.32a is revised to read as
follows:
§ 4.32a

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) 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 fining or
processing agents, must be declared on
a label affixed to the container, except
when subject to an approved petition for
exemption described in § 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

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allergen is derived (for example,
‘‘Contains: egg’’).
(c) Cross reference. For labeling
requirements applicable to wines
containing FD&C Yellow No. 5 and
sulfites, see §§ 4.32(c) and (e).
4. Section 4.32b is revised to read as
follows:

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§ 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 § 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 § 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 the 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, http://www.ttb.gov, all

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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
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
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.

2. In § 5.32, paragraph (b)(6), which is
currently reserved, is added to read as
follows:
§ 5.32

Mandatory label information.

*

*
*
*
*
(b) * * *
(6) If a major food allergen as defined
in § 5.32a is used in the production of

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a distilled spirits product, a statement as
required by that section.
*
*
*
*
*
3. Section 5.32a is revised to read as
follows:
§ 5.32a

Major food allergens.

(a) Definitions.
(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) Labeling requirements. 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
fining or processing agents, must be
declared on a label affixed to the
container, except when subject to an
approved petition for exemption
described in § 5.32b. The declaration
must consist of the word ‘‘Contains’’
followed by a colon and the name of the
food source from which each major food

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allergen is derived (for example,
‘‘Contains: Egg’’).
(c) Cross reference. For labeling
requirements applicable to distilled
spirits products containing FD&C
Yellow No. 5 and sulfites, see
§§ 5.32(b)(5) and (b)(7).
4. Section 5.32b is revised to read as
follows:

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§ 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 § 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 § 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 the 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

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public Web site, http://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
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 7—LABELING AND
ADVERTISING OF MALT BEVERAGES
1. The authority citation for 27 CFR
part 7 continues to read as follows:
Authority: 27 U.S.C. 205.

2. In § 7.22, paragraph (b)(5), which is
currently reserved, is added to read as
follows:
§ 7.22

Mandatory Label Information.

*

*
*
*
*
(b) * * *
(5) If a major food allergen as defined
in § 7.22a is used in the production of

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42343

a malt beverage, a statement as required
by that section.
*
*
*
*
*
3. Section 7.22a is revised to read as
follows:
§ 7.22a

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) Labeling requirements. All major
food allergens (defined in paragraph
(a)(1) of this section) used in the
production of a malt beverage product,
including major food allergens used as
fining or processing agents, must be
declared on a label affixed to the
container, except when subject to an
approved petition for exemption
described in § 7.22b. The declaration
must consist of the word ‘‘Contains’’

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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 labeling
requirements applicable to malt
beverage products containing FD&C
Yellow No. 5, sulfites, and aspartame,
see §§ 7.22(b)(4), (b)(6), and (b)(7).
4. Section 7.22b is revised to read as
follows:

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§ 7.22b 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 § 7.22a. 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 § 7.22a(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 the 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.

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(d) Availability of information. (1)
General. TTB will promptly post to its
public Web site, http://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
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.
Signed: February 16, 2006.
John J. Manfreda,
Administrator.
Approved: March 16, 2006.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and
Tariff Policy).
[FR Doc. 06–6467 Filed 7–25–06; 8:45 am]
BILLING CODE 4810–31–P

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DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
48 CFR Part 52
[FAR Case 2006–012; Docket 2006–0020;
Sequence 4]
RIN: 9000–AK51

Federal Acquisition Regulation; FAR
Case 2006–012; Contract Terms and
Conditions Required to Implement
Statute or Executive Orders—
Commercial Items
Department of Defense (DoD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Proposed rule.
AGENCIES:

SUMMARY: The Civilian Agency
Acquisition Council and the Defense
Acquisition Regulations Council
(Councils) are proposing to amend the
Federal Acquisition Regulation (FAR) to
update the required contract clauses
that implement provisions of law or
executive orders for acquisitions of
commercial items.
DATES: Interested parties should submit
written comments to the FAR
Secretariat on or before September 25,
2006 to be considered in the
formulation of a final rule.
ADDRESSES: Submit comments
identified by FAR case 2006–012 by any
of the following methods:
•Federal eRulemaking Portal: http://
acquisition.gov. Follow the instructions
for submitting comments.
• Agency Web site: http://
acquisition.gov/far/ProposedRules/
proposed.htm. Click on the FAR case
number to submit comments.
• E-mail: farcase.2006–012@gsa.gov.
Include FAR case 2006–012 in the
subject line of the message.
• Fax: 202–501–4067.
• Mail: General Services
Administration, Regulatory Secretariat
(VIR), 1800 F Street, NW, Room 4035,
ATTN: Laurieann Duarte, Washington,
DC 20405.
Instructions: Please submit comments
only and cite FAR case 2006–012 in all
correspondence related to this case. All
comments received will be posted
without change to http://
acquisition.gov/far/ProposedRules/
proposed.htm, including any personal
and/or business confidential
information provided.

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26JYP1