Labeling and Establishment Responsibilities
Since July 1, 1996, the Labeling and Program Delivery Division (LPDD) of FSIS only grants temporary approvals and sketch approvals. Before submitting label applications for sketch approval, establishments should ensure that the print is legible and that all required features (i.e., inspection legend, ingredients statement, handling statement, product name, signature line, and safe handling instructions, net weight, and nutrition facts, when required) are present and in compliance with requirements.
The generic approval labeling regulations ( 9 CFR 317.5 and 381.133 provide for use of final labeling without further authorization from FSIS. It is the establishment's responsibility to prepare final labeling in accordance with applicable regulations/policies, and to create and maintain records of final labeling, otherwise known as generic
- Create a record of final labeling for labeling previously approved as a sketch by the Labeling Compliance Team.
- Modifications (per sketch approval) are made to label before final printing
- Create a record of final labeling for amenable single ingredient products or amenable standardized multi-ingredient products that bears no special claims, guarantees, foreign language
- Create a record of final labeling when minor changes occur to labeling as permitted by generically approved labeling regulations 9 CFR 317.5(b)(9) and 381.133(b)(9), e.g., changes to net weight, vignette, serving instructions, etc.
- Create a record for any other final labeling as indicated by 9 CFR 317.5(b) and 381.133(b), e.g., shipping containers, animal food, legends, etc.
- Maintain labeling records
- Temporary approvals
- Final labeling (generic approvals)
Generic Label Record (Final Labeling)
Each generic label record consists of:
- The actual product's label
- The product formulation
- Processing procedure
- Sketch approvals, if appropriate
Establishments should also refer to FSIS's labeling approval regulations in 9 CFR 317.4 and 381.132 and required recordkeeping regulations for labeling in 9 CFR 320.1(b)(11) and 381.175(b)(6). For additional information, please contact the LPDD at (301) 504-0878 regarding policy issues and the Labeling Compliance Team, at (301) 504-0879 regarding label applications and procedural guidance.