[Code of Federal Regulations]
[Title 27, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 27CFR4.32b]

[Page 27-28]
 
            TITLE 27--ALCOHOL, TOBACCO PRODUCTS AND FIREARMS
 
 CHAPTER I--ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE 
                                TREASURY
 
PART 4_LABELING AND ADVERTISING OF WINE--Table of Contents
 
                Subpart D_Labeling Requirements for Wine
 
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

[[Page 28]]

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]