[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR381.132]

[Page 492]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 381_POULTRY PRODUCTS INSPECTION REGULATIONS--Table of Contents
 
                    Subpart N_Labeling and Containers
 
Sec. 381.132  Labeling approval.

    (a) No final labeling shall be used on any product unless the sketch 
labeling of such final labeling has been submitted for approval to the 
Food Labeling Division, Regulatory Programs, Food Safety and Inspection 
Service, and approved by such division, accompanied by FSIS Form, 
Application for Approval of Labels, Marking, and Devices, except for 
generically approved labeling authorized for use in Sec. 381.133(b) 
(2)-(9). The management of the official establishment or establishment 
certified under a foreign inspection system, in accordance with subpart 
T of this part, must maintain a copy of all labeling used, along with 
the product formulation and processing procedure, in accordance with 
subpart Q of this part. Such records shall be made available to any duly 
authorized representative of the Secretary upon request.
    (b) The Food Labeling Division shall permit submission for approval 
of only sketch labeling, as defined in Sec. 381.132(d), for all 
products, except as provided in Sec. 381.133(b) (2)-(9) and except for 
temporary use of final labeling as prescribed in paragraph (f) of this 
section.
    (c) All labeling required to be submitted for approval as set forth 
in Sec. 381.132(b) shall be submitted in duplicate to the Food Labeling 
Division, Regulatory Programs, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250. A parent company for a 
corporation may submit only one labeling application (in duplicate) for 
a product produced in other establishments that are owned by the 
corporation.
    (d) ``Sketch'' labeling is a printer's proof or equivalent which 
clearly shows all labeling features, size, location, and indication of 
final color, as specified in subpart N of this part. FSIS will accept 
sketches that are hand drawn, computer generated or other reasonable 
facsimiles that clearly reflect and project the final version of the 
labeling. Indication of final color may be met by: submission of a color 
sketch, submission of a sketch which indicates by descriptive language 
the final colors, or submission with the sketch of previously approved 
final labeling that indicates the final colors.
    (e) Inserts, tags, liners, pasters, and like devices containing 
printed or graphic matter and for use on, or to be placed within, 
containers and coverings of product shall be submitted for approval in 
the same manner as provided for labeling in Sec. 381.132(a), except 
that such devices which contain no reference to product and bear no 
misleading feature shall be used without submission for approval as 
prescribed in Sec. 381.133(b)(9).
    (f)(1) Consistent with the requirements of this section, temporary 
approval for the use of a final label or other final labeling that may 
otherwise be deemed deficient in some particular may be granted by the 
Food Labeling Division. Temporary approvals may be granted for a period 
not to exceed 180 calendar days under the following conditions:
    (i) The proposed labeling would not misrepresent the product;
    (ii) The use of the labeling would not present any potential health, 
safety, or dietary problems to the consumer;
    (iii) Denial of the request would create undue economic hardship; 
and
    (iv) An unfair competitive advantage would not result from the 
granting of the temporary approval.
    (2) Extensions of temporary approvals may also be granted by the 
Food Labeling Division, provided that the applicant demonstrates that 
new circumstances, meeting the above criteria, have developed since the 
original temporary approval was granted.

[60 FR 67456, Dec. 29, 1995]