[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2007]

From the U.S. Government Printing Office via GPO Access

[CITE: 9CFR317.4]



[Page 171-172]

 

                  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.



[[Page 172]]



    (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 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]