[Federal Register: July 26, 2006 (Volume 71, Number 143)]
[Rules and Regulations]
[Page 42260-42270]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy06-7]
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DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade Bureau
27 CFR Parts 4, 5, and 7
[T.D. TTB-53; Re: Notice No. 62]
RIN 1513-AB08
Major Food Allergen Labeling for Wines, Distilled Spirits, and
Malt Beverages
AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury.
ACTION: Interim rule; Treasury decision.
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SUMMARY: This interim rule, which parallels the recent amendments to
the Federal Food, Drug and Cosmetic Act contained in the Food Allergen
Labeling and Consumer Protection Act of 2004, adopts labeling standards
for major food allergens used in the production of alcohol beverages
subject to the labeling requirements of the Federal Alcohol
Administration Act.
In addition, elsewhere in this issue of the Federal Register, we
are publishing a notice of proposed rulemaking that proposes to make
major food allergen labeling mandatory. That notice solicits comments
from the public, including consumers and affected industry members, on
the proposed labeling requirements and the time frame for making the
requirements mandatory.
Under the interim regulations, producers, bottlers, and importers
of wines, distilled spirits, and malt beverages may voluntarily declare
the presence of milk, eggs, fish, Crustacean shellfish, tree nuts,
wheat, peanuts, and soybeans, as well as ingredients that contain
protein derived from these foods, in their products, but are not
required to do so. The interim regulations, however, set forth rules
that are mandatory for how industry members must undertake such
labeling, should they choose to do so. The regulations also contain
procedures for petitioning for an exemption from the standards imposed
on those alcohol beverage producers who wish to make voluntary allergen
statements on their product labels.
DATES: Effective Date: This interim rule is effective on July 26, 2006.
FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, Regulations and
Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box
128, Morganza, MD 20660; telephone (301) 290-1460.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, the presence of food allergens in foods has become
a matter of public concern. In response, Congress passed the Food
Allergen Labeling and Consumer Protection Act of 2004 to require the
declaration in labeling of major food allergens in plain, common
language on the foods regulated under the Federal Food, Drug and
Cosmetic Act. A House of Representatives committee report also noted
that the committee expected the Alcohol and Tobacco Tax and Trade
Bureau (TTB) to issue regulations on allergen labeling for alcohol
beverage products under TTB's existing authority to regulate alcohol
beverage labeling, working in cooperation with the Food and Drug
Administration (FDA). In addition, TTB had earlier received a petition
concerning ingredient and allergen labeling for alcohol beverages. In
response, TTB is issuing these interim regulations regarding voluntary
labeling of major food allergens used in the production of alcohol
beverage products. TTB also is proposing mandatory major food allergen
labeling for alcohol beverage products in a notice of proposed
rulemaking published elsewhere in this issue of the Federal Register.
A. FAA Act
TTB is responsible for the administration of the Federal Alcohol
Administration Act, 27 U.S.C. 201 et seq., (FAA Act), which governs,
among other things, the labeling of wines containing at least 7 percent
alcohol by volume, distilled spirits, and malt beverages in interstate
and foreign commerce. These products are generically referred to as
``alcohol beverages'' or ``alcohol beverage products'' throughout this
document.
In particular, section 105(e) of the FAA Act (27 U.S.C. 205(e))
gives the Secretary of the Treasury authority to issue regulations
regarding the labeling of alcohol beverages to provide the consumer
with adequate information concerning the identity and quality of such
products, to prevent deception of the consumer, and to prohibit false
or misleading statements. Section 105(e) also makes it unlawful for
industry members ``to sell or ship or deliver for sale or shipment, or
otherwise introduce in interstate or foreign commerce, or to receive
therein, or to remove from customs custody for consumption, any
distilled spirits, wine, or malt beverages in bottles, unless such
products are bottled, packaged, and labeled in conformity'' with
regulations prescribed by the Secretary. Regulations setting forth
mandatory labeling information requirements for wine, distilled
spirits, and malt beverages are contained, respectively, in parts 4, 5,
and 7 of the TTB regulations (27 CFR parts 4, 5, and 7).
Most of the mandatory labeling requirements found in parts 4, 5,
and 7 flow directly from the stated purpose of section 105(e) of the
FAA Act, that is, to ``provide the consumer with adequate information
as to the identity and quality of the products, the alcoholic content
thereof * * *, the net contents of the package, and the manufacturer or
bottler or importer of the product.'' Currently, the TTB labeling
regulations contained in parts 4, 5, and 7 require the following
information to appear on alcohol beverage labels: Brand name; product
identity (class or type); the name and address of the bottler, packer,
or importer; the net contents; and the alcohol content of distilled
spirits, certain flavored malt beverage products, and wines over 14
percent alcohol by volume. Labels for wines with 14 percent alcohol by
volume or less may contain either an alcohol content statement or the
type designation
[[Page 42261]]
``table'' wine or ``light'' wine (see 27 CFR part 4.36(a)). In
addition, labels must note the presence of sulfites, FD&C Yellow No. 5,
and in the case of malt beverages, aspartame. A health warning
statement applicable to all alcohol beverages containing 0.5 percent or
more alcohol by volume is required by the Alcoholic Beverage Labeling
Act of 1988, codified at 27 U.S.C. 213-219 and 219a and implemented in
the TTB regulations at 27 CFR part 16.
B. Current Health-Risk Ingredient Disclosure on Alcohol Beverage Labels
Our predecessor agency, the Bureau of Alcohol, Tobacco and Firearms
(ATF), proposed on several occasions to adopt mandatory ingredient
disclosure requirements for alcohol beverages. In each case, ATF
ultimately decided not to adopt full ingredient labeling requirements.
(See Notice No. 41, 70 FR 22274, April 29, 2005, for a more complete
history of those ingredient labeling regulatory initiatives.)
These rulemaking actions included publication of T.D. ATF-150 (48
FR 45549, October 6, 1983), which rescinded the ingredient disclosure
regulations that had been published in T.D. ATF-66 (45 FR 40538, June
13, 1980), but never implemented. T.D. ATF-150 did, however, mandate
the disclosure of one ingredient, FD&C Yellow No. 5, on alcohol
beverage labels. In the preamble to T.D. ATF-150, ATF stated:
* * * there is no clear evidence in the record that any other
ingredient besides FD&C Yellow No. 5 poses any special health
problem. The Department will look at the necessity of mandatory
labeling of other ingredients on a case-by-case basis through its
own rulemaking initiative, or on the basis of petitions for
rulemaking under 5 U.S.C. 553(e) and 27 CFR 71.41(c).
In conformity with that case-by-case review policy, ATF
subsequently issued regulations requiring the disclosure on labels of
sulfites in alcohol beverages (T.D. ATF-236, 51 FR 34706, September 30,
1986), because it was determined that the presence of undeclared
sulfites in alcohol beverages posed a recognized health problem to
sulfite-sensitive individuals.
In 1987, ATF entered into a Memorandum of Understanding (MOU) with
FDA. See 52 FR 45502 (November 30, 1987). In the MOU, ATF made a
commitment to consult with FDA regarding the necessity of requiring
labeling statements for ingredients in alcohol beverages that pose a
recognized public health problem and to initiate rulemaking proceedings
to require disclosure of such ingredients where appropriate. The
pertinent portion of the MOU states:
ATF will be responsible for the promulgation and enforcement of
regulations with respect to the labeling of distilled spirits, wine,
and malt beverages pursuant to the FAA Act. When FDA has determined
that the presence of an ingredient in food products, including
alcoholic beverages, poses a recognized public health problem, and
that the ingredient or substance must be identified on a food
product label, ATF will initiate rulemaking proceedings to
promulgate labeling regulations for alcoholic beverages consistent
with ATF's health policy with respect to alcoholic beverages. ATF
and FDA will consult on a regular basis concerning the propriety of
promulgating regulations concerning the labeling of other
ingredients and substances for alcoholic beverages.
Pursuant to the policies set forth in the MOU, ATF subsequently
issued regulations requiring a declaration on labels when aspartame is
used in the production of malt beverages (T.D. ATF-347, 58 FR 44131,
August 19, 1993). It should be noted that FD&C Yellow No. 5, sulfites,
and aspartame are not considered food allergens because they do not
cause IgE (Immunoglobulin E)-mediated responses, but they may cause
health problems in certain individuals.
C. Petition From Dr. Christine Rogers
On April 10, 2004, Christine A. Rogers, PhD., a senior research
scientist in the Exposure, Epidemiology and Risk Program at the Harvard
School of Public Health, petitioned TTB to change the regulations to
require labeling of all ingredients and substances used in the
production of alcohol beverages.
Dr. Rogers stated that she is allergic to egg protein and that she
has had allergic reactions to egg in wine. For that reason, she
expressed particular concern with the labeling of allergenic substances
in alcohol beverage products. Dr. Rogers noted that allergic symptoms
in consumers can include tingling or itching in the mouth, salivation,
swelling of tissues, hives, abdominal cramps, vomiting, diarrhea, rapid
loss of blood pressure, and death. She explained that allergic
reactions to food vary based upon an individual's sensitivity to a
particular allergen. The most sensitive allergic individuals are
required to carry epinephrine with them for emergency use in the case
of exposure to an offending allergen.
D. Enactment of FALCPA
On August 2, 2004, the President signed into law the Food Allergen
Labeling and Consumer Protection Act of 2004 (FALCPA) (see title II of
Pub. L. 108-282, 118 Stat. 905). FALCPA amends portions of the Federal
Food, Drug and Cosmetic Act (FD&C Act, 21 U.S.C. 301, et seq.) to
require a food that is, or contains an ingredient that bears or
contains, a major food allergen to list this information on its label
using plain, common language. For example, instead of merely listing
``semolina,'' the label must also list ``wheat'', and instead of merely
listing ``sodium casein,'' the label must also list ``milk.'' The
FALCPA amendments define ``major food allergens'' as milk, egg, fish,
Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well
as most ingredients containing proteins derived from these foods.
The effect of the FALCPA amendments is to add additional allergen
information to the food label. The FALCPA amendments provide two ways
for a manufacturer to disclose major food allergens on the label:
The label can show the name of the food source from which
the major food allergen is derived within parentheses in the ingredient
list, for example, ``Ingredients: Water, wheat, whey (milk), albumen
(eggs), and peanuts''; or
The label can list the name of the food source from which
the allergen is derived in summary form after, or adjacent to, an
ingredient list, for example: ``Ingredients: Water, sugar, whey, and
albumen. Contains: Milk and egg.''
Section 202 of FALCPA contains a number of congressional findings
regarding the health risk posed by allergens. Congress found that
approximately 2 percent of adults and 5 percent of infants and young
children in the United States suffer from food allergies. Each year,
roughly 30,000 individuals require emergency room treatment and 150
individuals die because of allergic reactions to food.
Congress found that the eight foods or food groups identified in
FALCPA account for 90 percent of all food allergies. Since there is
currently no cure for food allergies, a food-allergic consumer must
avoid the food to which he or she is allergic. Congress further found
that many consumers may not realize that a labeled food ingredient is
derived from, or contains, a major food allergen. The FALCPA amendments
fill this gap by ensuring that the food source from which a major food
allergen is derived is clearly labeled in plain language.
FALCPA amends food labeling requirements in the FD&C Act. Pursuant
to authority delegated to it by the Secretary of Health and Human
Services, FDA is responsible for promoting and protecting the public
health through enforcement of the FD&C
[[Page 42262]]
Act and for ensuring that the nation's food supply is properly labeled.
However, it is TTB's responsibility to issue regulations with respect
to the labeling of wine, distilled spirits, and malt beverages under
the FAA Act. See the 1987 ATF-FDA MOU and Brown-Forman Distillers Corp.
v. Mathews, 435 F. Supp. 5 (W.D. Ky. 1976).
The allergen labeling requirements in FALCPA apply to any food, as
that term is defined in section 201(f) of the FD&C Act, other than raw
agricultural commodities. As reflected in the 1987 MOU with FDA, TTB is
responsible for the promulgation and enforcement of regulations with
respect to the labeling of distilled spirits, wines, and malt beverages
pursuant to the FAA Act. The House of Representatives Committee on
Energy and Commerce called for TTB to work with FDA to promulgate
appropriate allergen labeling regulations for alcohol beverages labeled
under the FAA Act and TTB regulations, consistent with the 1987 MOU
with FDA. The committee report accompanying FALCPA stated:
The Committee expects, consistent with the November 30, 1987
Memorandum of Understanding, that the Alcohol and Tobacco Tax and
Trade Bureau (TTB) of the Department of Treasury will pursuant to
the Federal Alcohol Administration Act determine how, as
appropriate, to apply allergen labeling of beverage alcohol products
and the labeling requirements for those products. The Committee
expects that the TTB and the FDA will work together in promulgation
of allergen regulations, with respect to those products. (H.R. Rep.
No. 608, 108th Cong., 2d Sess., at 3 (2004); hereafter ``House
committee report.'')
Congress thus recognized TTB's longstanding policy of consulting
with FDA in determining what ingredients in alcohol beverages should be
disclosed on labels, and called on TTB to work with FDA to promulgate
appropriate allergen labeling regulations for alcohol beverages. The
clear intent reflected in the House committee report is that TTB issue
regulations similar to the FALCPA standards, pursuant to the policies
expressed in the MOU with FDA and the authority of the FAA Act.
Under the MOU, the two agencies have over the years collaborated on
many food safety issues and continue to exchange a wide variety of
information, including relevant consumer complaints concerning the
adulteration of alcohol beverages. The agencies consult regularly
concerning the use and labeling of potentially harmful ingredients and
substances in alcohol beverages. The laboratories of FDA and TTB
regularly exchange information concerning methodologies and techniques
for testing alcohol beverages.
Consistent with the expectations expressed in the House committee
report, TTB consulted with FDA prior to issuing this interim rule.
However, it should be emphasized that while this interim rule is
promulgated in response to, among other things, the expectations set
out in the legislative history of FALCPA, TTB's legal authority to
establish this rule is based on the FAA Act.
FDA is the agency authorized to implement FALCPA with regard to
foods. The House committee has set forth its expectation that TTB will
implement allergen labeling for alcohol beverages, as appropriate, and
will work with FDA in this effort. While TTB has generally strived to
be consistent with FDA's interpretation of FALCPA, the implementation
of regulations regarding major food allergen labeling for alcohol
beverages under the FAA Act will necessarily differ in some respects
from the requirements of FALCPA.
Accordingly, this interim rule reflects TTB's interpretation of its
authority under the FAA Act, as guided by the language in the committee
report. This regulation does not necessarily represent the views of FDA
with regard to allergen labeling or the requirements of FALCPA.
II. Rulemaking History and Summary of Comments
On April 29, 2005, TTB published in the Federal Register (70 FR
22274) Notice No. 41, an advance notice of proposed rulemaking (the
ANPRM). The notice was entitled ``Labeling and Advertising of Wines,
Distilled Spirits and Malt Beverages; Request for Public Comment.'' We
provided a 60-day period for comments from consumers, interest groups,
trade associations, industry, and other members of the public on
several alcohol beverage labeling issues, including calorie and
carbohydrate claims on labels, ``serving facts'' labeling, ``alcohol
facts'' labeling, ingredient labeling, allergen labeling, and composite
label approaches.
In the ANPRM, we invited comments on specific issues related to
allergen labeling, including: Whether our regulations should require
allergen labeling to be part of or adjacent to a list of ingredients,
similar to the FALCPA requirements; whether an allergen must be labeled
in an allergen statement even when the allergen name already appears in
the product name; how processing or fining agents should be labeled;
whether we should consider threshold levels in allergen labeling; what
costs industry may incur from new labeling requirements; and how
consumers might benefit from allergen labeling. We also invited
submission of any other relevant information on the subject of allergen
labeling.
During the 60-day comment period, we received several requests from
alcohol beverage industry representatives and organizations to extend
the comment period for an additional 60 to 90 days beyond the original
June 28, 2005, closing date. In support of the extension requests,
industry members noted that some of the questions posed in the notice
were broad and far reaching from a policy standpoint while others were
very technical, requiring research and coordination within the affected
industries. In response to these requests, we extended the comment
period for an additional 90 days. See Notice No. 48, 70 FR 36359, June
23, 2005. The extended comment period for the ANPRM closed on September
26, 2005.
We received more than 18,000 comments in response to the ANPRM,
approximately 50 of which specifically addressed the subject of
allergen labeling. Based on the clearly expressed congressional
interest in allergen labeling, the particular risks that allergens pose
to human health, FALCPA's effective date of January 1, 2006, and the
relatively small number of comments submitted on allergen issues, we
have decided to separate the allergen labeling rulemaking from the
other issues discussed in the ANPRM. We will review the comments
submitted on the other ANPRM issues, with a view to determining whether
to proceed with future rulemaking action in those areas, separately
from our action on allergen labeling. Accordingly, this document only
addresses allergen issues, including the approximately 50 comments on
allergens submitted in response to the ANPRM.
We note that of the comments we received on allergens, the vast
majority favored mandatory labeling of the major food allergens.
Industry members as well as consumer and public health advocates
commented in support of major food allergen labeling.
The major trade associations representing the alcohol beverage
industry expressed their support for mandatory labeling of major food
allergens. The Beer Institute, the Brewers Association, the Distilled
Spirits Council of the United States (DISCUS), the National Association
of Beverage Importers (NABI), the Presidents' Forum, Spirits Canada,
Wine America, and the Wine Institute submitted a consolidated comment,
in which they stated that they fully
[[Page 42263]]
supported the purpose and objectives of FALCPA and stood ready to work
with TTB in the implementation of allergen labeling. In a separate
comment, the Brewers Association stated that ``mandatory rules
regarding the disclosure of major allergens are necessary because
certain types of allergens, or at least when present above
scientifically determined harmful levels, can pose a significant threat
to consumer health.''
Consumer and public health interest groups also submitted comments
in support of mandatory labeling of major food allergens. The National
Consumers League (NCL) submitted a comment supported by several groups,
including the American Public Health Association and the American
School Health Association. This comment urged TTB to adopt a uniform,
mandatory labeling regime for all alcohol beverages that includes,
among other things, an ingredient declaration listing each ingredient
by its common or usual name and identifying any major food allergens
present in the product. The Center for Science in the Public Interest
(CSPI), a nonprofit health education and advocacy organization,
submitted a comment in support of the adoption of a mandatory allergen
disclosure policy for alcohol beverages consistent with the FALCPA
requirements for food and the FDA policies implementing FALCPA.
We also received comments in support of allergen labeling from the
American Medical Association; the American Academy of Allergy, Asthma
and Immunology; the American College of Allergy, Asthma and Immunology;
the Food Allergy and Anaphylaxis Network; the American Council on
Science and Health; the American Society of Addiction Medicine; the
American Dietetic Association; the American Nurses Association; Shape
Up America; and several other public health organizations and health
professionals.
Only a few comments questioned the usefulness of requiring allergen
information on alcohol beverage labels. Furthermore, there were some
disagreements among the commenters about the allergen labeling
implementation issues that we raised in the ANPRM.
III. Interim Regulatory Changes
After careful consideration of the comments on this issue, TTB has
determined that it should propose rules for the mandatory labeling of
major food allergens used in the production of alcohol beverages.
Consistent with the guidance expressed in the House committee report
and our statutory mandate under the FAA Act to promulgate regulations
ensuring that consumers receive adequate information about the identity
and quality of alcohol beverages, we believe that alcohol beverage
labels should provide consumers with sufficient information about the
use of major food allergens in the production of alcohol beverages so
that allergic consumers may make an informed decision as to whether
consumption of a particular beverage may pose a risk of an allergic
reaction. Accordingly, we are proposing mandatory labeling of major
food allergens elsewhere in this issue of the Federal Register.
As explained below, we are issuing this interim rule to provide
immediate guidance to industry members who wish to place allergen
statements on alcohol beverage labels on a voluntary basis. The interim
regulations also allow for the immediate filing of petitions for
exemptions from the standards imposed on those producers who wish to
make voluntary allergen statements on their labels.
A. Voluntary Labeling Approach
We note that in response to the ANPRM, some commenters urged TTB to
require labeling of major food allergens for products labeled on or
after January 1, 2006, which is the effective date of the FALCPA
amendments. One commenter suggested that consumers will expect to see
allergen information on alcohol beverage products at the same time that
such information begins appearing on food labels under FALCPA, and that
they may be misled by the absence of such information on labels of
products that in fact contain major food allergens. Other commenters,
recognizing that it may take some time before a final rule is issued,
suggested that TTB allow voluntary labeling of major food allergens
pending the completion of rulemaking.
In this regard, it should be noted that the congressional
committees involved with FALCPA had different expectations of FDA and
of TTB. The report of the Senate Committee on Health, Education, Labor,
and Pensions, S. Rep. No. 226, 108th Cong., 2d Sess., at 10 (2004)
(hereafter ``Senate committee report''), states:
The committee intends the requirements of section 403(w) to be
self-implementing. FDA will not be required to issue regulations to
implement section 403(w). FDA may issue guidance, should the agency
find that guidance would assist manufacturers or distributors,
particularly small businesses, to comply with the requirements in
this legislation.
On the other hand, as previously noted, the House committee report
specifically stated its expectation that TTB would promulgate
regulations, in consultation with FDA, to apply allergen labeling
requirements to alcohol beverages, as appropriate. Given that the TTB
regulations must be amended in order to implement allergen labeling, we
believe it is appropriate to allow the public, including affected
industry members, the opportunity to comment on allergen labeling
standards before making them mandatory.
Accordingly, in order to make allergen labeling standards
applicable to alcohol beverages at the earliest practicable date, and
before the public comment procedures can be completed, TTB has
determined that the best approach is to adopt voluntary regulatory
standards for major food allergen labeling through an interim rule. TTB
agrees with those commenters who suggested that producers of alcohol
beverages be given immediate guidance with respect to the voluntary use
of allergen labeling statements on labels. We have already received
inquiries from industry members about the voluntary use of allergen
statements on alcohol beverage labels. Because industry members may
wish to begin providing allergen information to consumers on a
voluntary basis right away, we are publishing standards that are
effective immediately.
The interim rule also gives industry members an opportunity to file
petitions for exemption from the standards imposed on those alcohol
beverage producers who wish to make voluntary allergen statements on
their product labels.
This interim rule amends parts 4, 5, and 7 of the TTB regulations
to include specific requirements for those who choose to place
voluntary declarations of major food allergens on labels. The
amendments include the addition of new sections 4.32a, 5.32a, and
7.22a, which set forth specific format requirements for the voluntary
labeling of major food allergens. In addition, we have added new
sections 4.32b, 5.32b, and 7.22b, which allow any person to petition
TTB for an exemption from the labeling standards that apply if
voluntary major food allergen labeling is undertaken. A detailed
discussion of the specific provisions within the interim regulations
follows.
In consideration of the requirements for prior public notice and
comment procedures under the Administrative Procedure Act, we are
proposing the adoption of mandatory labeling standards in a separate
document, Notice No. 62, which is published in the
[[Page 42264]]
Proposed Rules section of this issue of the Federal Register. The
voluntary standards adopted in this interim rule document will remain
in place until they are replaced by final action on the proposal for
mandatory standards.
B. Labeling of Major Food Allergens
1. Definitions
Consistent with the FALCPA amendments, the interim regulations
provide that when allergen labeling is undertaken, the product must be
labeled ``Contains:'' followed by the name of the food source from
which each major food allergen is derived, as set forth in the
definition of ``major food allergen.''
The definition of the term ``major food allergen'' is consistent
with the statutory definition in FALCPA. The interim regulations define
the term ``major food allergen'' as any of the following: ``Milk, egg,
fish (for example, bass, flounder, or cod), Crustacean shellfish (for
example, crab, lobster, or shrimp), tree nuts (for example, almonds,
pecans, or walnuts), wheat, peanuts, and soybeans.'' The term as
defined also includes any food ingredient that contains protein derived
from one of these eight foods or food groups, subject to certain
exceptions explained below.
It should be noted that, consistent with guidance provided by FDA
to the food industry, the interim regulations allow the terms
``soybean,'' ``soy,'' and ``soya'' as synonyms for the term
``soybeans,'' as used in the statute. Furthermore, also consistent with
FDA guidance, the singular term ``peanut'' may be substituted for the
plural term ``peanuts,'' and singular terms (for example, almond,
pecan, or walnut) may be used in place of plural terms to describe the
different types of tree nuts.
2. Labeling of Fish Species
FALCPA provides that in the case of tree nuts, the label must list
the name of the specific type of nut (for example, almonds, pecans, or
walnuts). In the case of Crustacean shellfish, the label must list the
name of the species of shellfish (for example, crab, lobster, or
shrimp). Finally, in the case of fish, the FALCPA amendments provide
that the name of the species of fish (for example, bass, flounder, or
cod) must appear on the label.
The interim regulations are consistent with the FALCPA amendments
with respect to the labeling of tree nuts and Crustacean shellfish.
However, for the reasons explained below, the interim regulations set
forth in this document do not require labeling of the specific fish
species when an industry member chooses to provide major food allergen
information. The regulations instead require simply listing ``fish''
when any type of finfish protein is used in the production of an
alcohol beverage.
Isinglass and fish gelatin are often used to clarify wines and
beers. Isinglass is a substance obtained from the swim bladders of
sturgeon and other fish. Fish gelatin is obtained from the skin of a
fish. Fish gelatin most often is made from cod skins but can be made
from any species of fish.
Vintners and brewers, when purchasing isinglass or fish gelatin
from a manufacturer for fining purposes, often do not know, and have no
way of easily finding out, which particular species of fish was used to
make the product. Moreover, it may be difficult for industry members to
determine by chemical analysis which particular fish species was the
source of the isinglass or fish gelatin.
On August 1, 2005, the Flavor and Extract Manufacturers Association
of the United States (FEMA) submitted a request to FDA for guidance
concerning the labeling of fish species under the FALCPA amendments. In
its request for guidance, FEMA asked FDA to allow for use of the term
``fish'' for labeling ``non-nutritive fish ingredients'' used in
flavors. FEMA cited clinical and scientific evidence in support of its
argument that many fish-allergic individuals will react adversely to
more than one species of fish.
TTB recognizes that FALCPA requires the labeling of the particular
species of fish used as an ingredient in a food product. However, it is
our responsibility to implement allergen labeling regulations that are
appropriate for alcohol beverages. It is likely that declarations of
the use of fish in the production of alcohol beverages will generally
involve the use of isinglass or fish gelatin as a processing aid.
Because of the particular difficulty faced by the producer in
determining the specific species of fish used in producing the
isinglass or fish gelatin, and because at least some consumers may be
allergic to more than one species of fish, TTB is persuaded that
requiring labeling with the name of the specific type of fish would
impose a difficult fact-finding burden on the alcohol beverage industry
without offering consumers who may be allergic to more than one species
of fish any significant additional information to help them avoid the
risk of an allergic reaction. Accordingly, we believe that the goal of
the FALCPA amendments with respect to alcohol beverages is adequately
met if alcohol beverages produced using finfish protein are labeled
merely with ``fish,'' rather than with the name of the fish species.
We would note that the data on this matter are not conclusive, and
we are specifically inviting comments on this issue in our notice of
proposed rulemaking. However, for purposes of the guidance provided in
this interim rule for industry members who wish to make voluntary
allergen labeling statements, we believe that there is a basis for
concluding that a reference to ``fish'' on the label will provide
adequate information to consumers about the presence of finfish protein
in certain alcohol beverages.
3. Processing and Fining Agents
FALCPA amends the FD&C Act to require that, notwithstanding any
other provision of law, a flavoring, coloring, or incidental additive
that is or bears or contains a major food allergen must conform to
FALCPA's labeling requirements. See 21 U.S.C. 343(w)(4). The FDA
regulations define the term ``incidental additive'' to include, among
other things, processing aids. See 21 CFR 101.100(a)(3). Therefore, if
alcohol beverage industry members choose to make major food allergen
declarations, the interim regulations treat major food allergens used
as fining or processing agents in the same way as any other major food
allergen used in the production of the alcohol beverage.
4. Threshold Levels
The FALCPA amendments, which took effect for foods labeled on or
after January 1, 2006, require allergen labeling for foods regulated by
FDA without the establishment of any threshold levels for labeling.
Furthermore, pursuant to our authority under the FAA Act to ensure that
labels provide consumers with adequate information about the identity
and quality of alcohol beverage products, the interim regulations
provide that if an industry member chooses to label for any major food
allergen, all major food allergens and proteins derived from the major
food allergens used in production must be declared on the beverage
label, unless the product or class of products is covered by an
approved petition for exemption. Accordingly, TTB is not setting
thresholds in this interim regulation.
TTB believes that this position will ensure that consumers have
adequate information about the potential presence of even trace amounts
of major food allergens in alcohol beverage products. As more accurate
scientific data become available in the future, we may revisit the
threshold issue as appropriate.
[[Page 42265]]
C. Exceptions From Allergen Labeling Requirements
The interim regulations contain three exceptions from major food
allergen labeling. Two of these exceptions are provided within the
definition of ``major food allergen,'' and the third is an exemption
through a TTB petition process.
1. Highly Refined Oil
The FALCPA amendments exclude from the definition of ``major food
allergen'' any highly refined oil derived from one of the eight foods
or food groups listed in that definition and any ingredient derived
from such highly refined oil. The Senate committee report at page 7
indicates that the exception for highly refined oils was intended to
apply to refined, bleached, deodorized (RBD) oils. Both the House
committee report at page 16 and the Senate committee report at page 7
specifically identify peanut oil as one of the highly refined oils
covered by the exception. We believe this exception from labeling for
highly refined oils is also appropriate in the case of alcohol
beverages, and we therefore have included this as an exception from the
definition of a major food allergen in the interim regulatory texts.
2. Exemptions Under the FD&C Act
FALCPA added two processes to the FD&C Act at 21 U.S.C. 343(w)(6)
and (7) by which any person may obtain an exemption from the allergen
labeling requirements imposed by the statute.
Subsection (w)(6) allows any person to petition the Secretary of
Health and Human Services to exempt a food ingredient from the allergen
labeling requirements. Under its delegated authority, FDA performs the
function of the Secretary in this area. In this situation, the burden
is on the petitioner to provide scientific evidence (including the
analytical method used to produce the evidence) that demonstrates that
the food ingredient, as derived by the method specified in the
petition, does not cause an allergic response that poses a risk to
human health. FDA must approve or deny any such petition within 180
days of receipt or the petition will be deemed denied, unless an
extension is mutually agreed upon by FDA and the petitioner.
Subsection (w)(7) allows any person to file a notification
containing scientific evidence demonstrating that an ingredient ``does
not contain allergenic protein.'' The scientific evidence must include
the analytical method used to produce the evidence that the ingredient,
as derived by the method specified in the notification, does not
contain allergenic protein. Alternatively, the notification may contain
a determination from FDA under a premarket approval or notification
program provided for in section 409 of the FD&C Act (21 U.S.C. 348)
that the ingredient does not cause an allergic response that poses a
risk to human health. FDA has 90 days to object to a notification.
Absent an objection, the food ingredient is exempt from the FDA
labeling requirements for major food allergens.
Many ingredients and food additives used in the production of foods
regulated by FDA are also used in the production of alcohol beverages
regulated by TTB. Under the two exemption processes described above,
certain ingredients and food additives may be exempted from the
allergen labeling requirements of the FD&C Act. We believe it is
appropriate to allow alcohol beverage industry members to rely on the
exemptions from major food allergen labeling requirements allowed under
the FD&C Act and FDA procedures. We have therefore included in the
definition of ``major food allergen'' an exception for uses of food
ingredients that are exempt pursuant to 21 U.S.C. 343(w)(6) or (7).
It is important to note in this regard that alcohol beverage
industry members must consider two issues when determining whether an
ingredient exempted under the FD&C Act is also not subject to TTB
allergen labeling requirements. First, the ingredient they used or
intend to use in a product must be the same ingredient that is exempt
under the FD&C Act. Second, the proposed use must be consistent with
any conditions of use in the FD&C Act exemption for the ingredient.
3. Petitions for Exemption From TTB Regulations
We also recognize that major food allergens are used in alcohol
beverage production in ways that may differ from the way they are used
in the production of foods regulated by FDA. For this reason, new
sections 4.32a, 5.32a, and 7.22a refer in each case to an exception for
a product covered by a petition for exemption approved under new
section 4.32b, 5.32b, or 7.22b. A petition may pertain to the use of a
major food allergen in the production of one specific alcohol beverage
product or it may pertain to a class of products using a particular
process involving a major food allergen.
As stated above, TTB's jurisdiction extends to the labeling of
wines, distilled spirits, and malt beverages. Accordingly, we only will
accept a petition seeking an exemption from the labeling of a major
food allergen when the material in question is used in the production
of an alcohol beverage product regulated by TTB. If an exemption from
the FD&C Act allergen labeling requirements is also desired, the
interested party must submit a petition or notification to FDA under 21
U.S.C. 343(w)(6) or (7), rather than submit a petition under the
applicable TTB regulation.
The use of the TTB petition process is similar to that of the
petition and notification processes provided for at 21 U.S.C. 343(w)(6)
and (7), except that the TTB petition procedure focuses on products
instead of ingredients. The TTB petition process may be used:
When it is asserted that the product or class of products,
as derived by the method specified in the petition, does not cause an
allergic response that poses a risk to human health; or
When it is asserted that the product or class of products,
as derived by the method specified in the petition, does not contain
allergenic protein, even though a major food allergen was used in
production.
The interim TTB regulations provide for only a petition procedure,
rather than both the petition procedure and the notification procedure
provided for in the FALCPA amendments to the FD&C Act. We believe that
having one petition procedure, rather than separate petition and
notification procedures, will simplify the process for industry, and
will allow our personnel adequate time to review the evidence presented
in each request for an exemption. TTB is not in a position to
administer a 90-day notice procedure similar to the notification
procedure in subsection (w)(7) of the statute. The interim regulation
petition procedure is therefore similar to the petition procedure in
subsection (w)(6) of the statute in that the regulation places the
burden on the petitioner to provide evidence in support of the
exemption and gives TTB 180 days to respond.
The interim regulations provide that a petition for exemption from
major food allergen labeling must be submitted to the appropriate TTB
officer. The appropriate TTB officer to whom petitions must be
submitted is the Assistant Administrator, Headquarters Operations. The
petition should be sent to the Alcohol and Tobacco Tax and Trade
Bureau, 1310 G Street NW., Suite 200E, Washington, DC 20220 and should
bear the notation: ``Attention: Petition for Exemption from Major Food
Allergen Labeling'' to ensure prompt processing.
[[Page 42266]]
In addition, the interim regulations provide that if TTB does not
approve or deny the petition for exemption within 180 days of receipt,
the petition is deemed denied, unless an extension of time is mutually
agreed upon by TTB and the petitioner. The regulations also provide
that a determination under this section constitutes a final agency
action and that even though a petition is deemed denied because no
action was taken within the 180-day period, the petitioner may resubmit
the petition at any time. A resubmitted petition will be treated as a
new petition.
As a result of FDA's implementation of FALCPA and our establishment
of this interim rule, TTB and FDA will both be regulating allergen
labeling, with TTB overseeing labeling for alcohol beverages and FDA
the labeling for all other products that are foods under the FD&C Act.
As noted, TTB and FDA are parties to an MOU signed in 1987. That MOU
provides that FDA and TTB will exchange information generally about
appropriate labeling for, and the adulteration of, alcohol beverages,
including information about methodologies and techniques for testing
such beverages. Consistent with these general MOU provisions and both
agencies' recognition that, generally, the regulation of allergen
labeling should be consistent for alcohol beverages and all other
foods, TTB intends to confer with FDA, as appropriate and as FDA
resources permit, on petitions submitted under this interim rule.
Consistent with FALCPA, the interim rule places the burden on the
petitioner to provide adequate evidence in its initial petition
submission to justify an exemption from labeling. TTB may require the
subsequent submission of product samples and other additional
information in support of a petition; however, unless required by TTB,
the submission of samples or additional information by the petitioner
after submission of the petition will be treated as the withdrawal of
the initial petition and the submission of a new petition.
FALCPA provides that FDA shall promptly post to a public site all
petitions within 14 days of receipt and shall promptly post the
Government's response to each. Our interim regulations are consistent
with FALCPA's requirement to make petitions and responses available to
the public, but may go beyond the requirements of FALCPA in some
respects. The interim regulations provide that petitions submitted to
TTB, and TTB's response to those petitions, will be posted to the TTB
Web site (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 may request that TTB give confidential treatment to that
information. The interim regulations set forth the standards for making
such a request. A failure to request confidential treatment at the time
the information in question is submitted to TTB will constitute a
waiver of confidential treatment.
IV. Notice of Proposed Rulemaking
In the Proposed Rules section of this issue of the Federal
Register, we have published a notice of proposed rulemaking, Notice No.
62, to solicit public comment on our proposal to impose mandatory
allergen labeling requirements on alcohol beverage products. That
notice gives the public, including affected industry members, an
opportunity to comment on the mandatory labeling of major food
allergens, the time required by industry members to incorporate the
required changes on their labels, and how to minimize any added
compliance costs.
V. Regulatory Analysis and Notices
A. Executive Order 12866
We have determined that this interim rule is not a significant
regulatory action as defined in Executive Order 12866. Therefore, a
regulatory assessment is not required.
B. Regulatory Flexibility Act
Because this interim rule was not required to be preceded by a
notice of proposed rulemaking, the provisions of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) do not apply.
C. Paperwork Reduction Act
This interim rule includes a new collection of information
involving the declaration of major food allergens on an alcohol
beverage label and the submission of petitions for exemption from
allergen labeling. This collection is voluntary.
The collection of information has been reviewed and, pending
receipt and evaluation of public comments, approved by the Office of
Management and Budget (OMB) under 44 U.S.C. 3507(j) and assigned
control number 1513-0121. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a valid control number assigned by OMB.
The collection of information is contained in Sec. Sec. 4.32a,
4.32b, 5.32a, 5.32b, 7.22a, and 7.22b. The likely respondents are
individuals and business or other for-profit institutions, including
partnerships, associations, and corporations.
Estimated total annual reporting and/or recordkeeping
burden: 730 hours.
Estimated average annual burden per respondent/
recordkeeper: 1.46 hours.
Estimated number or respondents and/or recordkeepers: 500.
Estimated annual number of responses: 520.
Comments on this collection of information may be sent by e-mail to
OMB at Alexander_T._Hunt@omb.eop.gov, or by paper mail to Office of
Management and Budget, Attention: Desk Officer for the Department of
the Treasury, Office of Information and Regulatory Affairs, Washington,
DC 20503. A copy should also be sent to TTB at one of the following
addresses:
P.O. Box 14412, Washington, DC 20044-4412;
202-927-8525 (facsimile); or
formcomments@ttb.gov (e-mail).
Please reference the information collection's title and OMB number
in your comment. If you submit your comment via facsimile, send no more
than five 8.5 x 11 inch pages in order to ensure electronic access to
our equipment.
Comments are invited on the accuracy of the burden. We also invite
suggestions on how the burden may be reduced.
VI. Inapplicability of Prior Notice and Comment and Delayed Effective
Date Procedures
It has been determined, pursuant to 5 U.S.C. 553(b)(B) and (d),
that good cause exists to issue these regulations without prior notice
and public procedure, and without a delayed effective date. Because the
industry needs immediate standards for the placement of voluntary
statements listing major food allergens on alcohol beverage labels, and
because industry members may wish to begin immediately to submit
petitions for exemptions, it is impracticable and contrary to the
public interest to issue these regulations for prior notice and
comment, and with a delayed effective date.
[[Page 42267]]
VII. Drafting Information
The principal author of this document was Jessica M. Bungard,
Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade
Bureau. However, other personnel participated in its development.
List of Subjects
27 CFR Part 4
Administrative practice and procedure, Advertising, Customs duties
and inspection, Imports, Labeling, Packaging and containers, Reporting
and recordkeeping requirements, Trade practices, Wine.
27 CFR Part 5
Administrative practice and procedure, Advertising, Customs duties
and inspection, Distilled spirits, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements, Trade practices.
27 CFR Part 7
Administrative practice and procedure, Advertising, Customs duties
and inspection, Imports, Labeling, Malt beverages, Reporting and
recordkeeping requirements, Trade practices.
Amendments to the Regulations
0
For the reasons discussed in the preamble, TTB amends 27 CFR parts 4,
5, and 7 as follows:
PART 4--LABELING AND ADVERTISING OF WINE
0
1. The authority citation for 27 CFR part 4 continues to read as
follows:
Authority: 27 U.S.C. 205.
0
2. A new Sec. 4.32a is added to read as follows:
Sec. 4.32a Voluntary disclosure of major food allergens.
(a) Definitions. For purposes of this section the following terms
have the meanings indicated.
(1) Major food allergen. Major food allergen means any of the
following:
(i) Milk, egg, fish (for example, bass, flounder, or cod),
Crustacean shellfish (for example, crab, lobster, or shrimp), tree nuts
(for example, almonds, pecans, or walnuts), wheat, peanuts, and
soybeans; or
(ii) A food ingredient that contains protein derived from a food
specified in paragraph (a)(1)(i) of this section, except:
(A) Any highly refined oil derived from a food specified in
paragraph (a)(1)(i) of this section and any ingredient derived from
such highly refined oil; or
(B) A food ingredient that is exempt from major food allergen
labeling requirements pursuant to a petition for exemption approved by
the Food and Drug Administration (FDA) under 21 U.S.C. 343(w)(6) or
pursuant to a notice submitted to FDA under 21 U.S.C. 343(w)(7),
provided that the food ingredient meets the terms or conditions, if
any, specified for that exemption.
(2) Name of the food source from which each major food allergen is
derived. Name of the food source from which each major food allergen is
derived means the name of the food as listed in paragraph (a)(1)(i) of
this section, except that:
(i) In the case of a tree nut, it means the name of the specific
type of nut (for example, almonds, pecans, or walnuts);
(ii) In the case of Crustacean shellfish, it means the name of the
species of Crustacean shellfish (for example, crab, lobster, or
shrimp); and
(iii) The names ``egg'' and ``peanuts'', as well as the names of
the different types of tree nuts, may be expressed in either the
singular or plural form, and the term ``soy'', soybean'', or ``soya''
may be used instead of ``soybeans''.
(b) Voluntary labeling standards. Major food allergens (defined in
paragraph (a)(1) of this section) used in the production of a wine may,
on a voluntary basis, be declared on any label affixed to the
container. However, if any one major food allergen is voluntarily
declared, all major food allergens used in production of the wine,
including major food allergens used as fining or processing agents,
must be declared, except when covered by a petition for exemption
approved by the appropriate TTB officer under Sec. 4.32b. The major
food allergens declaration must consist of the word ``Contains''
followed by a colon and the name of the food source from which each
major food allergen is derived (for example, ``Contains: egg'').
(c) Cross reference. For mandatory labeling requirements applicable
to wines containing FD&C Yellow No. 5 and sulfites, see Sec. Sec.
4.32(c) and (e).
0
3. A new Sec. 4.32b is added to read as follows:
Sec. 4.32b Petitions for exemption from major food allergen labeling.
(a) Submission of petition. Any person may petition the appropriate
TTB officer to exempt a particular product or class of products from
the labeling requirements of Sec. 4.32a. The burden is on the
petitioner to provide scientific evidence (including the analytical
method used to produce the evidence) that demonstrates that the
finished product or class of products, as derived by the method
specified in the petition, either:
(1) Does not cause an allergic response that poses a risk to human
health; or
(2) Does not contain allergenic protein derived from one of the
foods identified in Sec. 4.32a(a)(1)(i), even though a major food
allergen was used in production.
(b) Decision on petition. TTB will approve or deny a petition for
exemption submitted under paragraph (a) of this section in writing
within 180 days of receipt of the petition. If TTB does not provide a
written response to the petitioner within that 180-day period, the
petition will be deemed denied, unless an extension of time for
decision is mutually agreed upon by the appropriate TTB officer and the
petitioner. TTB may confer with the Food and Drug Administration (FDA)
on petitions for exemption, as appropriate and as FDA resources permit.
TTB may require the submission of product samples and other additional
information in support of a petition; however, unless required by TTB,
the submission of samples or additional information by the petitioner
after submission of the petition will be treated as the withdrawal of
the initial petition and the submission of a new petition. An approval
or denial under this section will constitute a final agency action.
(c) Resubmission of a petition. After a petition for exemption is
denied under this section, the petitioner may resubmit the petition
along with supporting materials for reconsideration at any time. TTB
will treat this submission as a new petition for purposes of the time
frames for decision set forth in paragraph (b) of this section.
(d) Availability of information. (1) General. TTB will promptly
post to its public Web site, 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
[[Page 42268]]
submitted to TTB will constitute a waiver of confidential treatment. A
request for confidential treatment of information under this section
must conform to the following standards:
(i) The request must be in writing;
(ii) The request must clearly identify the information to be kept
confidential;
(iii) The request must relate to information that constitutes trade
secrets or other confidential commercial or financial information
regarding the business transactions of an interested person, the
disclosure of which would cause substantial harm to the competitive
position of that person;
(iv) The request must set forth the reasons why the information
should not be disclosed, including the reasons the disclosure of the
information would prejudice the competitive position of the interested
person; and
(v) The request must be supported by a signed statement by the
interested person, or by an authorized officer or employee of that
person, certifying that the information in question is a trade secret
or other confidential commercial or financial information and that the
information is not already in the public domain.
PART 5--LABELING AND ADVERTISING OF DISTILLED SPIRITS
0
1. The authority citation for 27 CFR part 5 continues to read as
follows:
Authority: 26 U.S.C. 5301, 7805, 27 U.S.C. 205.
0
2. A new Sec. 5.32a is added to read as follows:
Sec. 5.32a Voluntary disclosure of major food allergens.
(a) Definitions. For purposes of this section the following terms
have the meanings indicated.
(1) Major food allergen. Major food allergen means any of the
following:
(i) Milk, egg, fish (for example, bass, flounder, or cod),
Crustacean shellfish (for example, crab, lobster, or shrimp), tree nuts
(for example, almonds, pecans, or walnuts), wheat, peanuts, and
soybeans; or
(ii) A food ingredient that contains protein derived from a food
specified in paragraph (a)(1)(i) of this section, except:
(A) Any highly refined oil derived from a food specified in
paragraph (a)(1)(i) of this section and any ingredient derived from
such highly refined oil; or
(B) A food ingredient that is exempt from major food allergen
labeling requirements pursuant to a petition for exemption approved by
the Food and Drug Administration (FDA) under 21 U.S.C. 343(w)(6) or
pursuant to a notice submitted to FDA under 21 U.S.C. 343(w)(7),
provided that the food ingredient meets the terms or conditions, if
any, specified for that exemption.
(2) Name of the food source from which each major food allergen is
derived. Name of the food source from which each major food allergen is
derived means the name of the food as listed in paragraph (a)(1)(i) of
this section, except that:
(i) In the case of a tree nut, it means the name of the specific
type of nut (for example, almonds, pecans, or walnuts);
(ii) In the case of Crustacean shellfish, it means the name of the
species of Crustacean shellfish (for example, crab, lobster, or
shrimp); and
(iii) The names ``egg'' and ``peanuts'', as well as the names of
the different types of tree nuts, may be expressed in either the
singular or plural form, and the term ``soy'', soybean'', or ``soya''
may be used instead of ``soybeans''.
(b) Voluntary labeling standards. Major food allergens (defined in
paragraph (a)(1) of this section) used in the production of a distilled
spirit product may, on a voluntary basis, be declared on any label
affixed to the container. However, if any one major food allergen is
voluntarily declared, all major food allergens used in production of
the distilled spirit product, including major food allergens used as
fining or processing agents, must be declared, except when covered by a
petition for exemption approved by the appropriate TTB officer under
Sec. 5.32b. The major food allergens declaration must consist of the
word ``Contains'' followed by a colon and the name of the food source
from which each major food allergen is derived (for example,
``Contains: egg'').
(c) Cross reference. For mandatory labeling requirements applicable
to distilled spirits products containing FD&C Yellow No. 5 and
sulfites, see Sec. Sec. 5.32(b)(5) and (7).
0
3. A new Sec. 5.32b is added to read as follows:
Sec. 5.32b Petitions for exemption from major food allergen labeling.
(a) Submission of petition. Any person may petition the appropriate
TTB officer to exempt a particular product or class of products from
the labeling requirements of Sec. 5.32a. The burden is on the
petitioner to provide scientific evidence (including the analytical
method used to produce the evidence) that demonstrates that the
finished product or class of products, as derived by the method
specified in the petition, either:
(1) Does not cause an allergic response that poses a risk to human
health; or
(2) Does not contain allergenic protein derived from one of the
foods identified in Sec. 5.32a(a)(1)(i), even though a major food
allergen was used in production.
(b) Decision on petition. TTB will approve or deny a petition for
exemption submitted under paragraph (a) of this section in writing
within 180 days of receipt of the petition. If TTB does not provide a
written response to the petitioner within that 180-day period, the
petition will be deemed denied, unless an extension of time for
decision is mutually agreed upon by the appropriate TTB officer and the
petitioner. TTB may confer with the Food and Drug Administration (FDA)
on petitions for exemption, as appropriate and as FDA resources permit.
TTB may require the submission of product samples and other additional
information in support of a petition; however, unless required by TTB,
the submission of samples or additional information by the petitioner
after submission of the petition will be treated as the withdrawal of
the initial petition and the submission of a new petition. An approval
or denial under this section will constitute a final agency action.
(c) Resubmission of a petition. After a petition for exemption is
denied under this section, the petitioner may resubmit the petition
along with supporting materials for reconsideration at any time. TTB
will treat this submission as a new petition for purposes of the time
frames for decision set forth in paragraph (b) of this section.
(d) Availability of information. (1) General. TTB will promptly
post to its public Web site, 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
[[Page 42269]]
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
0
1. The authority citation for 27 CFR part 7 continues to read as
follows:
Authority: 27 U.S.C. 205.
0
2. A new Sec. 7.22a is added to read as follows:
Sec. 7.22a Voluntary disclosure of major food allergens.
(a) Definitions. For purposes of this section the following terms
have the meanings indicated.
(1) Major food allergen. Major food allergen means any of the
following:
(i) Milk, egg, fish (for example, bass, flounder, or cod),
Crustacean shellfish (for example, crab, lobster, or shrimp), tree nuts
(for example, almonds, pecans, or walnuts), wheat, peanuts, and
soybeans; or
(ii) A food ingredient that contains protein derived from a food
specified in paragraph (a)(1)(i) of this section, except:
(A) Any highly refined oil derived from a food specified in
paragraph (a)(1)(i) of this section and any ingredient derived from
such highly refined oil; or
(B) A food ingredient that is exempt from major food allergen
labeling requirements pursuant to a petition for exemption approved by
the Food and Drug Administration (FDA) under 21 U.S.C. 343(w)(6) or
pursuant to a notice submitted to FDA under 21 U.S.C. 343(w)(7),
provided that the food ingredient meets the terms or conditions, if
any, specified for that exemption.
(2) Name of the food source from which each major food allergen is
derived. Name of the food source from which each major food allergen is
derived means the name of the food as listed in paragraph (a)(1)(i) of
this section, except that:
(i) In the case of a tree nut, it means the name of the specific
type of nut (for example, almonds, pecans, or walnuts); and
(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 name ``soy'', ``soybean'', or ``soya''
may be used instead of ``soybeans''.
(b) Voluntary labeling standards. Major food allergens (defined in
paragraph (a)(1) of this section) used in the production of a malt
beverage product may, on a voluntary basis, be declared on any label
affixed to the container. However, if any one major food allergen is
voluntarily declared, all major food allergens used in production of
the malt beverage product, including major food allergens used as
fining or processing agents, must be declared, except when covered by a
petition for exemption approved by the appropriate TTB officer under
Sec. 7.22b. The major food allergens declaration must consist of the
word ``Contains'' followed by a colon and the name of the food source
from which each major food allergen is derived (for example,
``Contains: egg'').
(c) Cross reference. For mandatory labeling requirements applicable
to malt beverage products containing FD&C Yellow No. 5, sulfites, and
aspartame, see Sec. Sec. 7.22(b)(4), (b)(6), and (b)(7).
0
3. A new Sec. 7.22b is added 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. 7.22(a)(1)(i), even though a major food
allergen was used in production.
(b) Decision on petition. TTB will approve or deny a petition for
exemption submitted under paragraph (a) of this section in writing
within 180 days of receipt of the petition. If TTB does not provide a
written response to the petitioner within that 180-day period, the
petition will be deemed denied, unless an extension of time for
decision is mutually agreed upon by the appropriate TTB officer and the
petitioner. TTB may confer with the Food and Drug Administration (FDA)
on petitions for exemption, as appropriate and as FDA resources permit.
TTB may require the submission of product samples and other additional
information in support of a petition; however, unless required by TTB,
the submission of samples or additional information by the petitioner
after submission of the petition will be treated as the withdrawal of
the initial petition and the submission of a new petition. An approval
or denial under this section will constitute a final agency action.
(c) Resubmission of a petition. After a petition for exemption is
denied under this section, the petitioner may resubmit the petition
along with supporting materials for reconsideration at any time. TTB
will treat this submission as a new petition.
(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;
[[Page 42270]]
(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. E6-11872 Filed 7-25-06; 8:45 am]
BILLING CODE 4810-31-P