I. PURPOSE

This directive supplements the instructions for performing the Public Health Information System (PHIS) General Labeling tasks in FSIS Directive 7221.1, Prior Labeling Approval by adding instructions for verifying that any transferred labels are properly used. FSIS is revising this directive in its entirety to align the tasks in this directive with PHIS.

II. CANCELLATION

FSIS Directive 7000.4, Verifying Certain Transferred Labeling, 12/8/08

III. BACKGROUND


        A. FSIS regulations (9 CFR 317.13 and 381.138(b)) allow an official establishment to transfer labels, wrappers, or containers bearing official marks with its establishment number to any other official establishment for temporary use. This transfer can only occur, however, in limited, special circumstances. For example, after a fire, an establishment may need to move its production to another facility. Likewise, to fill an unexpected large order, an establishment may need to arrange for temporary production at another facility. In these special circumstances, an establishment may transfer labels that bear its mark of inspection and establishment number to another establishment for use.

        B. Labeling bearing an establishment?s pre-printed mark of inspection and establishment number cannot be transferred, however, for normal or long-term use. An establishment that co-packs product for another establishment over an extended period, or a business entity that shifts production among several establishments that it owns, needs to apply approved labeling displaying the establishment number of the establishment using the transferred labeling (i.e., the receiving establishment) to comply with 9 CFR 317.2(c)(5) and 381.123.

        C. In a short-term situation, the establishment that receives transferred labeling needs to request temporary approval to use the labels (9 CFR 412) with the establishment number of the transferring establishment because one or more labeling features (i.e., the establishment number and possibly the name and place of business of the manufacturer, packer, or distributor) as described in 9 CFR 317.2(g) and 381.122 may not comply with the regulations. The Labeling and Program Delivery Staff (LPDS), which grants temporary approvals, looks for information supporting the request that explains why a transfer of labeling is needed, the transferring establishment?s label approval, the date of labeling shipment, the quantity of labeling, the type of labeling material, and the prominent code mark that will be applied to labeling in order to track the product. FSIS requires transferred labeling bearing a pre-printed establishment number (i.e., the tra nsferring establishment?s number) be code marked in order to identify the establishment using the transferred labeling (i.e., the receiving establishment).

        The code mark is a unique identifier, such as a numeric code consisting of the lot number and the establishment number in which the product was produced.

        D. The Agency requires the use of this prominent code mark to help the establishment using the transferred labeling (i.e., the receiving establishment), the public, and the Agency identify and track the product. Easy identification of the product is important if there is a problem leading to a voluntary market withdrawal or a product recall. Alternatively, the receiving establishment can either correct the transferred labeling (e.g., covering the pre-printed establishment number with a pressure sensitive sticker) to reflect the number of the establishment in which the product is processed (that is, the receiving establishment?s number.) The temporary approval will provide that transferred labeling bearing a pre-printed establishment number and prominent code mark can only be used for 60 days from the date of temporary approval unless the establishment number is corrected on the transferred labeling.

          E. If inspection personnel have any questions or concerns about an establishment?s use of transferred labeling, they are to request to review the temporary approval granted by LPDS in the establishment?s labeling records. Establishments are required to keep labeling records as described in 9 CFR Parts 320 and 381, Subpart Q.

IV. VERIFYING COMPLIANCE WITH FSIS? REGULATIONS ON THE USE OF TRANSFERRED LABELING BEARING A PRE-PRINTED ESTABLISHMENT NUMBER

        A. If, while conducting a PHIS General Labeling task, Inspection Program Personnel (IPP) encounter labels bearing another establishment?s number, they are to verify that LPDS granted temporary approval for the establishment to use the transferred labeling. As stated above, LPDS? temporary approval is required to be available in the establishment?s labeling records. IPP are to verify that the establishment is using the appropriate code mark identified in the temporary approval. They are also to verify that the establishment does not use the code-marked labeling more than 60 days after the date of temporary approval.

        B. IPP are to verify that if transferred labeling is used for more than 60 days, it complies with the regulations (9 CFR 317.2 (c)(5) or 381.123) by placement of a pressure-sensitive sticker bearing its own establishment number over the pre-printed establishment number to correct the label. This type of labeling change is generically approved under 9 CFR 412.2. Guidance about using pressure sensitive stickers is available at: https://www.fsis.usda.gov/guidelines/2020-0004#%3A%7E%3Atext%3DThe%20guidance%20provides%20information%20about%2Clabeling%20information%20with%20corrected%20text

        C. IPP are to retain product as necessary, and issue a Noncompliance Record (NR) under the General Labeling task and cite 9 CFR 412.1 when:

                1. The receiving establishment does not have temporary approval granted by LPDS in its labeling records to use transferred labeling bearing an establishment number other than its own with a code mark;

                2. The receiving establishment has received temporary approval to use transferred labeling bearing an establishment number other than its own but is not following the conditions of the temporary approval, e.g., it is not applying the appropriate code mark specified in the temporary approval granted by LPDS; or

                3.The receiving establishment is using transferred labeling bearing appropriate code marks, but it is using the code-marked labeling for more than 60 days after the date of temporary approval.

V. QUESTIONS

Refer questions regarding this directive to your supervisor or to the Office of Policy and Program Development (OPPD) 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.

NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.

Rachel A. Edelstein
Assistant Administrator
Office of Policy and Program Development