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Labeling and Establishment Responsibilities
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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
Establishment Responsibility
- 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.
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