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27 CFR
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).
[T.D. TTB-53, 71 FR 42267, July 26, 2006]
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 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 42267, July 26, 2006]
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).
[T.D. TTB-53, 71 FR 42268, July 26, 2006]
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
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]
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).
[T.D. TTB-53, 71 FR 42269, July 26, 2006]
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;
(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 42269, July 26, 2006]
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | TTB |
| File Modified | 0000-00-00 |
| File Created | 2021-02-03 |