27 CFR 5.32a-5.32b

pmangrum on DSK3VPTVN1PROD with CFR

Alcohol and Tobacco Tax and Trade Bureau, Treasury

§ 5.32b

gen 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 § 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
§§ 5.32(b)(5) and (7).

§ 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 aller-

[T.D. TTB–53, 71 FR 42268, July 26, 2006]

§ 5.32b Petitions for exemption from
major food allergen labeling.
(a) Submission of petition. Any person
may petition the appropriate TTB officer to exempt a particular product or
class of products from the labeling requirements of § 5.32a. The burden is on
the petitioner to provide scientific evidence (including the analytical method
used to produce the evidence) that
demonstrates that the finished product
or class of products, as derived by the
method specified in the petition, either:
(1) Does not cause an allergic response that poses a risk to human
health; or
(2) Does not contain allergenic protein derived from one of the foods identified in § 5.32a(a)(1)(i), even though a
major food allergen was used in production.
(b) Decision on petition. TTB will approve or deny a petition for exemption
submitted under paragraph (a) of this
section in writing within 180 days of receipt of the petition. If TTB does not
provide a written response to the petitioner within that 180-day period, the
petition will be deemed denied, unless
an extension of time for decision is mutually agreed upon by the appropriate
TTB officer and the petitioner. TTB
may confer with the Food and Drug
Administration (FDA) on petitions for
exemption, as appropriate and as FDA
resources permit. TTB may require the
submission of product samples and

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pmangrum on DSK3VPTVN1PROD with CFR

§ 5.33

27 CFR Ch. I (4–1–14 Edition)

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 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.
[T.D. TTB–53, 71 FR 42268, July 26, 2006]

§ 5.33

Additional requirements.

(a) Contrasting background. Labels
shall be so designed that the statements required by this subpart are
readily legible under ordinary conditions, and such statements shall be on
a contrasting background.
(b) Location of statements and size of
type. (1) Statements required by this
subpart, except brand names, shall appear generally parallel to the base on
which the bottle rests as it is designed
to be displayed or shall be otherwise
equally conspicuous.
(2) Statements required by this subpart, except brand names and the declaration of sulfites in § 5.32(b)(7), shall
be separate and apart from any other
descriptive or explanatory matters.
(3) If not separate and apart from
other descriptive or explanatory matter printed on the label, the statement
declaring the presence of sulfites shall
be of a size substantially more conspicuous than surrounding nonmandatory labeling information.
(4) Statements of the type of distilled
spirits shall be as conspicuous as the
statement of the class to which it refers, and in direct conjunction therewith.
(5) Statements required by this subpart, except brand names, shall be in
script, type, or printing not smaller
than 2 millimeters (or 8-point gothic
until January 1, 1983), except that, in
the case of labels on bottles of 200 milliliters or less capacity, such script,
type, or printing shall not be smaller
than 1 millimeter (or 6-point gothic
until January 1, 1983).

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