Prior Labeling Approval - Revision 2
This directive provides instructions to inspection program personnel (IPP) for conducting the General Labeling task in the Public Health Information System (PHIS). FSIS is reissuing this directive to clarify that labels eligible for the General Labeling task include those reviewed and approved by the Labeling and Program Delivery Staff (LPDS), as well as labels that were not approved by LPDS because they were generically approved under the conditions described in 9 CFR 412.2.
- Generic label approval criteria are in 9 CFR 412
- Any label that does not require evaluation by the LPDS as described in 9 CFR 412 is generically approved without evaluation if the label displays all mandatory label features in compliance with applicable Federal regulations
- IPP are to verify establishments receive necessary label approval and compliance with labeling requirements through the General Labeling task in PHIS
FSIS Directive 7221.1 Revision 1, Prior Labeling Approval, 01/06/14
III. LABEL APPROVAL
A. LPDS: The staff in the Office of Policy and Program Development (OPPD) responsible for implementing the Agency’s prior label approval system. LPDS also develops labeling policy, guidance to industry, and necessary instructions to IPP.
B. Prior Label Approval: All labels are to be approved before use (9 CFR 412.1(a)). Prior approval in the form of sketch approval or temporary approval from LPDS is to be obtained for labels described in 9 CFR 412.1(c). Prior approval is granted generically without submission to LPDS for labels that meet the requirements of 9 CFR 412.2.
C. Generic Label Approval: Prior approval of labels granted by the Agency without the company submitting the labels to LPDS for approval. Any label that does not meet one of the criteria in 9 CFR 412.1(c) is generically approved without submission to LPDS, provided the label displays all mandatory label features in compliance with applicable Federal regulations (9 CFR 412.2(b)).
D. Sketch Label Approval: A sketch label is a printer's proof or other version that clearly shows all required label features, size, location, and indication of final color. FSIS approves sketch labels after companies submit them to LPDS, and LPDS finds the label features meet regulatory requirements. Sketch approval is required for all labels described in 9 CFR 412.1(c).
E. Final Label Approval: A final label is a label that is applied to product before leaving the establishment. Final labels are approved generically without review from LPDS.
A. Pursuant to 9 CFR 412.1(c), there are four categories of labels that are to be evaluated and specifically approved by LPDS before use. These are:
- Labels for temporary approval;
- Labels for products prepared under religious exemption;
- Labels for products for export with deviations from FSIS labeling requirements; and
- Labels with special statements and claims. Special statements and claims are explained in detail in an FSIS compliance guide that is maintained online.
B. Any label that is not included in one or more of the above categories is generically approved if the label displays all mandatory label features in compliance with applicable Federal regulations (9 CFR 412.2). Refer to Table 1 in section V paragraph C for a list of the mandatory label features.
C. IPP are to be aware that establishments are responsible for ensuring that labels used for meat and poultry products are not false or misleading, and for ensuring that labels comply with the Federal meat and poultry products inspection regulations and policies.
D. IPP are to be aware that sketch labels (as defined in 9 CFR 412.1(d)), along with a completed form 7234-1 and all supporting documentation are to be submitted to LPDS for evaluation, except for labels that are generically approved. Labels that are to be submitted for evaluation are described in 9 CFR 412.1(c) (Section IV, part A of this Directive). Label submissions may be mailed in duplicate, or entered into the FSIS Label Submission and Approval System (LSAS). If a label is generically approved or if the sketch is approved by LPDS, establishments may print a final label, create a final label record in accordance with 9 CFR 320.1(b)(10) and 9 CFR Part 381.175(b)(6), and use the label in commerce without further authorization from FSIS.
E. Final labels that are not in compliance with Federal meat and poultry products inspection regulations may still be granted temporary approval under the conditions listed in 9 CFR 412.1(f). The final label along with a completed form 7234-1 and all supporting documentation, including support for conformity to the conditions in 9 CFR 412.1(f), are to be submitted to LPDS for temporary approval. Label submissions may be entered into LSAS or mailed in duplicate to LPDS.
V. IPP VERIFICATION ACTIVITIES IN OFFICIAL ESTABLISHMENTS
A. IPP in meat and poultry establishments are to continue to perform the General Labeling task when scheduled in PHIS. When scheduled, IPP are to randomly select one or more labels for verification from products in production at the assigned establishment. IPP are to routinely select generically approved labels when conducting this task. To complete this task, IPP are to select both labels that require a prior label approval from LPDS and those that are eligible for generic approval.
B. IPP are to verify that the establishment is maintaining records of the selected labels in accordance with 9 CFR 320.1(b)(10) for meat products and 9 CFR Part 381.175(b)(6) for poultry products. Labeling records are to be made available to FSIS field personnel and any authorized USDA official within 24 hours of request. Each labeling record should include: a copy of the final label that is in use, the product formulation, the processing procedure for the product, and any supporting documentation needed to show that the label is consistent with the Federal meat and poultry regulations and policies on labeling as described in 9 CFR 412.1. If the label requires LPDS evaluation per 9 CFR 412.1(c), form 7234-1, Application for Approval of Labels, Marking, or Device, is to be included in the labeling record and is to indicate that approval has been granted by LPDS. The final label is to comply with modifications and conditions of use put forth by LPDS in the label approval [9 CFR 412.1(a)].
C. IPP are to verify regulatory compliance of the final label by reviewing it for the presence of all applicable required features listed in Table 1: Required Labeling Features on page 2-3 on the directive.
*NOTE: All ingredients used in the product must be listed in the ingredients statement. Product is considered adulterated if an allergen is not listed in the ingredients statement. IPP are to contact their supervisor for guidance if at any time they have reason to believe that product failing to declare one of the “big 8” allergens [wheat, crustacean shellfish (e.g. crab, lobster, shrimp), eggs, fish, peanuts, milk, tree nuts (e.g. almonds, pecans, walnuts), and soybeans] or other ingredients of public health concern has entered commerce. FSIS ingredient and allergen compliance guidelines are available online.
VI. DETERMINING AND DOCUMENTING NONCOMPLIANCE
A. IPP are to document the results of their verification, including any noncompliance, in PHIS in a manner that accords with Chapter VI of FSIS Directive 7000.1, Verification of Non-food Safety Consumer Protection Regulatory Requirements.
B. When a label requires LPDS review and approval prior to use, and the labeling record does not include LPDS approval for that label, IPP are to document the noncompliance on a Noncompliance Record (NR) in PHIS, citing 9 CFR 412.1 as the relevant reference. If IPP are unsure as to whether a label requires LPDS approval, they are to contact LPDS for direction as identified in section IX of this directive. IPP are to retain any product bearing a label that requires, but has not received, LPDS approval. The establishment may take corrective action by obtaining label approval through LPDS as described in section IV, paragraph D, of this directive or by replacing the noncompliant labels with labels that have received prior approval and are in compliance with Federal meat and poultry inspection regulations and policies.
C. When a label is not in compliance with regulatory requirements, IPP are to document the noncompliance on an NR in PHIS, citing the relevant reference from Table 1. IPP are to retain any product bearing that label and require establishments to update labels that are not in compliance with FSIS’ labeling regulations. Before the product may enter commerce, the establishment must take corrective action by using a pressure sensitive sticker to correct the non-compliance, replacing the noncompliant label with a compliant label or, if applicable, obtaining temporary label approval through LPDS.
D. There may be times when an inspector is not performing the General Labeling task but observes a product label that is not in compliance with Federal meat and poultry regulations. For example, if during the course of duty, IPP find that an ingredient is not declared on the final label, the net weight is incorrect, or the order of predominance of the ingredients on the label is inaccurate, IPP are to initiate a directed General Labeling task, retain affected product, and document the noncompliance in PHIS as described above.
VII. SUPERVISORY RESPONSIBILITIES
A. Supervisors are to ensure that IPP are familiar with reviewing, and know how to review, labels and labeling records.
B. When “big 8” allergens or other ingredients of public health concern are not properly declared, a recall may be warranted. The FLS is to alert the District Office to potential distribution of products that pose a public health concern. Refer to FSIS Directive 8080.1, Recall of Meat and Poultry Products for additional information on the recall of meat and poultry products.
VIII. DATA ANALYSIS
PHIS tracks the inspection activities conducted by IPP. OPPD will review data from both the routine and directed PHIS General Labeling task, along with associated compliance and noncompliance data with respect to applicable regulations, to determine whether potential trends exist. Findings will be shared with the Office of Field Operations.
Refer questions regarding this directive to your supervisor or the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select Labeling for the Inquiry Type.