[Code of Federal Regulations]
[Title 9, Volume 2, Parts 200 to end]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.4]

[Page 164-165]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
 
                           Subpart A--General
 
Sec. 317.4  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. 317.5(b). The 
management of the official establishment or establishment certified 
under a foreign inspection system, in accordance with part 327 of this 
subchapter, must maintain a copy of all labeling used, along with the 
product formulation and processing procedure, in accordance with part 
320 of this subchapter. 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. 317.4(d), for all products, 
except as provided in Sec. 317.5(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. 317.4(a) 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 form) 
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 Sec. 317.2. 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. 317.4(a), except that 
such devices which contain no reference to product and bear no 
misleading feature shall be used without

[[Page 165]]

submission for approval as prescribed in Sec. 317.5(b)(7).
    (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.
    (g) The inspector-in-charge shall approve meat carcass ink brands 
and meat food product ink and burning brands, which comply with parts 
312 and 316 of this subchapter.

[60 FR 67454, Dec. 29, 1995]