[Federal Register: July 26, 2006 (Volume 71, Number 143)]
[Proposed Rules]
[Page 42329-42344]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy06-26]
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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).
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.
[[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 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.
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 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,
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
[[Page 42339]]
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 90-day 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, 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 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
[[Page 42340]]
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
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 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://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 e-mail 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
[[Page 42341]]
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.
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 Sec. Sec. 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 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.
VII. Drafting Information
The principal author of this document was Jessica M. Bungard,
Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade
Bureau. However, other personnel participated in its development.
List of Subjects
27 CFR Part 4
Administrative practice and procedure, Advertising, Customs duties
and inspection, Imports, Labeling, Packaging and containers, Reporting
and recordkeeping requirements, Trade practices, Wine.
27 CFR Part 5
Administrative practice and procedure, Advertising, Customs duties
and inspection, Distilled spirits, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements, Trade practices.
27 CFR Part 7
Administrative practice and procedure, Advertising, Customs duties
and inspection, Imports, Labeling, Malt Beverages, Reporting and
recordkeeping requirements, Trade practices.
Amendments to the Regulations
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 Sec. 4.32, paragraph (d), which is currently reserved, is
added to read as follows:
Sec. 4.32 Mandatory label information.
* * * * *
(d) If a major food allergen as defined in Sec. 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.
* * * * *
3. Section 4.32a is revised to read as follows:
Sec. 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 Sec. 4.32b.
The major food allergens declaration must consist of the word
``Contains'' followed by a colon and the name of the food source from
which each major food
[[Page 42342]]
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 Sec. Sec. 4.32(c) and
(e).
4. Section 4.32b is revised to read as follows:
Sec. 4.32b Petitions for exemption from major food allergen labeling.
(a) Submission of petition. Any person may petition the appropriate
TTB officer to exempt a particular product or class of products from
the labeling requirements of Sec. 4.32a. The burden is on the
petitioner to provide scientific evidence (including the analytical
method used to produce the evidence) that demonstrates that the
finished product or class of products, as derived by the method
specified in the petition, either:
(1) Does not cause an allergic response that poses a risk to human
health; or
(2) Does not contain allergenic protein derived from one of the
foods identified in Sec. 4.32a(a)(1)(i), even though a major food
allergen was used in production.
(b) Decision on petition. TTB will approve or deny a petition for
exemption submitted under paragraph (a) of this section in writing
within 180 days of receipt of the petition. If TTB does not provide a
written response to the petitioner within that 180-day period, the
petition will be deemed denied, unless an extension of time for
decision is mutually agreed upon by the appropriate TTB officer and the
petitioner. TTB may confer with the Food and Drug Administration (FDA)
on petitions for exemption, as appropriate and as FDA resources permit.
TTB may require the submission of product samples and other additional
information in support of 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 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 Sec. 5.32, paragraph (b)(6), which is currently reserved, is
added to read as follows:
Sec. 5.32 Mandatory label information.
* * * * *
(b) * * *
(6) If a major food allergen as defined in Sec. 5.32a is used in
the production of a distilled spirits product, a statement as required
by that section.
* * * * *
3. Section 5.32a is revised to read as follows:
Sec. 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 Sec. 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
[[Page 42343]]
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 Sec. Sec. 5.32(b)(5) and (b)(7).
4. Section 5.32b is revised to read as follows:
Sec. 5.32b Petitions for exemption from major food allergen labeling.
(a) Submission of petition. Any person may petition the appropriate
TTB officer to exempt a particular product or class of products from
the labeling requirements of Sec. 5.32a. The burden is on the
petitioner to provide scientific evidence (including the analytical
method used to produce the evidence) that demonstrates that the
finished product or class of products, as derived by the method
specified in the petition, either:
(1) Does not cause an allergic response that poses a risk to human
health; or
(2) Does not contain allergenic protein derived from one of the
foods identified in Sec. 5.32a(a)(1)(i), even though a major food
allergen was used in production.
(b) Decision on petition. TTB will approve or deny a petition for
exemption submitted under paragraph (a) of this section in writing
within 180 days of receipt of the petition. If TTB does not provide a
written response to the petitioner within that 180-day period, the
petition will be deemed denied, unless an extension of time for
decision is mutually agreed upon by the appropriate TTB officer and the
petitioner. TTB may confer with the Food and Drug Administration (FDA)
on petitions for exemption, as appropriate and as FDA resources permit.
TTB may require the submission of product samples and other additional
information in support of 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 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 Sec. 7.22, paragraph (b)(5), which is currently reserved, is
added to read as follows:
Sec. 7.22 Mandatory Label Information.
* * * * *
(b) * * *
(5) If a major food allergen as defined in Sec. 7.22a is used in
the production of a malt beverage, a statement as required by that
section.
* * * * *
3. Section 7.22a is revised to read as follows:
Sec. 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 Sec. 7.22b. The declaration must consist of the word
``Contains''
[[Page 42344]]
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 Sec. Sec. 7.22(b)(4), (b)(6), and (b)(7).
4. Section 7.22b is revised to read as follows:
Sec. 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 Sec. 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 Sec. 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.
(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