Major Food Allergen Labeling for Wines, Distilled Spirits and Malt Beverages, 42329-42344 [06-6467]

Agencies

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

[Federal Register Volume 71, Number 143 (Wednesday, July 26, 2006)]
[Proposed Rules]
[Pages 42329-42344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6467]


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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

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

ACTION: Notice of proposed rulemaking; solicitation of comments.

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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 
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).
     https://www.ttb.gov/alcohol/rules/index.htm. An online 
comment form is posted with this notice on our Web site.
     https://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.

[[Page 42330]]

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 beverages, aspartame. A health warning 
statement applicable to all alcohol beverages containing 0.5 percent or 
more alcohol by volume, is required by the Alcoholic Beverage Labeling 
Act of 1988, codified at 27 U.S.C. 213-219 and 219a and implemented in 
the TTB regulations at 27 CFR part 16.

B. Current Health-Risk Ingredient Disclosure on Alcohol Beverage Labels

    Our predecessor agency, the Bureau of Alcohol, Tobacco and Firearms 
(ATF), proposed on several occasions to adopt mandatory ingredient 
disclosure requirements for alcohol beverages. In each case, ATF 
ultimately decided not to adopt full ingredient labeling requirements. 
(See Notice No. 41, 70 FR 22274, April 29, 2005, for a more complete 
history of those ingredient labeling regulatory initiatives.)
    These rulemaking actions included publication of T.D. ATF-150 (48 
FR 45549, October 6, 1983), which rescinded the ingredient disclosure 
regulations that had been published in T.D. ATF-66 (45 FR 40538, June 
13, 1980), but never implemented. T.D. ATF-150 did, however, mandate 
the disclosure of one ingredient, FD&C Yellow No. 5, on alcohol 
beverage labels. In the preamble to T.D. ATF-150, ATF stated:

    * * * there is no clear evidence in the record that any other 
ingredient besides FD&C Yellow No. 5 poses any special health 
problem. The Department will look at the necessity of mandatory 
labeling of other ingredients on a case-by-case basis through its 
own rulemaking initiative, or on the basis of petitions for 
rulemaking under 5 U.S.C. 553(e) and 27 CFR 71.41(c).

    In conformity with that case-by-case review policy, ATF 
subsequently issued regulations requiring the disclosure on labels of 
sulfites in alcohol beverages (T.D. ATF-236, 51 FR 34706, September 30, 
1986) because it was determined that the presence of undeclared 
sulfites in alcohol beverages posed a recognized health problem to 
sulfite-sensitive individuals.
    In 1987, ATF entered into a Memorandum of Understanding (MOU) with 
FDA. See 52 FR 45502 (November 30, 1987). In the MOU, ATF made a 
commitment to consult with FDA regarding the necessity of requiring 
labeling statements for ingredients in alcohol beverages that pose a 
recognized public health problem and to initiate rulemaking proceedings 
to require disclosure of such ingredients where appropriate. The 
pertinent portion of the MOU states:

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

    Pursuant to the policies set forth in the MOU, ATF subsequently 
issued regulations requiring a declaration on labels when aspartame is 
used in the production of malt beverages (T.D. ATF-347, 58 FR 44131, 
August 19, 1993). It should be noted that FD&C Yellow No. 5, sulfites, 
and aspartame are not considered food allergens because they do not 
cause IgE (Immunoglobulin E)-mediated responses, but they may cause 
health problems in certain individuals.

C. Petition From Dr. Christine Rogers

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

D. Enactment of FALCPA

    On August 2, 2004, the President signed into law the Food Allergen 
Labeling and Consumer Protection Act of 2004 (FALCPA) (see title II of 
Pub. L. 108-282, 118 Stat. 905). FALCPA amends portions of the Federal 
Food, Drug and Cosmetic Act (FD&C Act, 21 U.S.C. 301 et seq.) to 
require a food that is, or contains an ingredient that bears or 
contains, a major food allergen to list

[[Page 42331]]

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 is TTB's responsibility to issue 
regulations with respect to the labeling of wine, distilled spirits, 
and malt beverages under the FAA Act. See the 1987 ATF-FDA MOU and 
Brown-Forman Distillers Corp. v. Mathews, 435 F. Supp. 5 (W.D. Ky. 
1976).
    The allergen labeling requirements in FALCPA apply to any food, as 
that term is defined in section 201(f) of the FD&C Act, other than raw 
agricultural commodities. As reflected in the 1987 MOU with FDA, TTB is 
responsible for the promulgation and enforcement of regulations with 
respect to the labeling of distilled spirits, wines, and malt beverages 
pursuant to the FAA Act. The House of Representatives Committee on 
Energy and Commerce called for TTB to work with FDA to promulgate 
appropriate allergen labeling regulations for alcohol beverages labeled 
under the FAA Act and TTB regulations, consistent with the 1987 MOU 
with FDA. The committee report accompanying FALCPA stated:

    The Committee expects, consistent with the November 30, 1987 
Memorandum of Understanding, that the Alcohol and Tobacco Tax and 
Trade Bureau (TTB) of the Department of Treasury will pursuant to 
the Federal Alcohol Administration Act determine how, as 
appropriate, to apply allergen labeling of beverage alcohol products 
and the labeling requirements for those products. The Committee 
expects that the TTB and the FDA will work together in promulgation 
of allergen regulations, with respect to those products. (H.R. Rep. 
No. 608, 108th Cong., 2d Sess., at 3 (2004); hereafter ``House 
committee report.'')

    Congress thus recognized TTB's longstanding policy of consulting 
with FDA in determining what ingredients in alcohol beverages should be 
disclosed on labels, and called on TTB to work with FDA to promulgate 
appropriate allergen labeling regulations for alcohol beverages. The 
clear intent reflected in the House committee report is that TTB issue 
regulations similar to the FALCPA standards, pursuant to the policies 
expressed in the MOU with FDA and the authority of the FAA Act.
    Under the MOU, the two agencies have over the years collaborated on 
many food safety issues and continue to exchange a wide variety of 
information, including relevant consumer complaints concerning the 
adulteration of alcohol beverages. The agencies consult regularly 
concerning the use and labeling of potentially harmful ingredients and 
substances in alcohol beverages. The laboratories of FDA and TTB 
regularly exchange information concerning methodologies and techniques 
for testing alcohol beverages.
    Consistent with the expectations expressed in the House committee 
report, TTB consulted with FDA prior to issuing this 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

[[Page 42332]]

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 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 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

[[Page 42333]]

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 substantial cost is incurred by the 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.)

    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

[[Page 42334]]

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:

    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 food allergen labeling provides 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 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

[[Page 42335]]

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 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 `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

[[Page 42336]]

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.

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 non-observed 
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 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.
TTB Response
    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 decisions related to those requirements.
    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.''

[[Page 42337]]

TTB Response
    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.

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 Sec.  4.32, a 
new paragraph (b)(6) in Sec.  5.32, and a new paragraph (b)(5) in Sec.  
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, 
Sec. Sec.  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, Sec. Sec.  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.

A. Labeling of Major Food Allergens

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.
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. Isinglass is a substance obtained from the swim bladders of 
sturgeon and other fish. Fish gelatin is obtained from the skin of a 
fish. Fish gelatin most often is made from cod skins but can be made 
from any species of fish.
    Vintners and brewers, when purchasing isinglass or fish gelatin 
from a manufacturer for fining purposes, often do not know, and have no 
way of easily finding out, which particular species of fish was used to 
make the product. Moreover, it may be difficult for industry members to 
determine by chemical analysis which particular fish species was the 
source of the isinglass or fish gelatin.
    On August 1, 2005, the Flavor and Extract Manufacturers Association 
of the United States (FEMA) submitted a request to FDA for guidance 
concerning the labeling of fish species under the FALCPA amendments. In 
its request for guidance, FEMA asked FDA to allow for use of the term 
``fish'' for labeling ``non-nutritive fish ingredients'' used in 
flavors. FEMA cited clinical and scientific evidence in support of its 
argument that many fish-allergic individuals will react adversely to 
more than one species of fish.
    TTB recognizes that 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.

[[Page 42338]]

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 p