Label Backlog Update and Tips for the Label Approval Process

FSIS is currently experiencing a delay of about 23-24 business days in evaluations for labels that require review prior to use. By providing industry with suggestions via the Constituent Update to assist with the submission of label applications, FSIS is hopeful that it will achieve a faster, more efficient label evaluation process.

TIP: When using a new livestock or poultry supplier in a product bearing approved animal raising claims on the label, an establishment may submit a letter in lieu of a new label application.

When FSIS approves a label with an animal raising claim, the documentation in the application must include relevant information regarding the supplier of the livestock or poultry. If an establishment wishes to use a different source of livestock or poultry that is also eligible to bear the same animal raising claim, the new supplier must also be approved by FSIS. Rather than submitting a new label application, the establishment may submit a signed and dated request to FSIS by email (Kierra.Lucas@usda.gov) or letter (see link below) that includes the following:

• The product name;
• The producing establishment’s name, address, and establishment number;
• The prior label approval number and date of approval;
• A copy of the previously approved label application;
• The specific claim(s) being used on the product label and date of approval;
• The new supplier’s name, address, and a copy of any labels with the same claim(s) previously approved by FSIS associated with the new supplier and/or any documentation to support the use of the claim(s) for the new supplier; and
• If applicable, a copy of the current third-party certificate(s) for claim(s) certified under a third-party organization.

Once the documentation has been reviewed, FSIS will notify the establishment in writing of its final determination, typically within 10 business days. Upon approval, the producing establishment must update their labeling record to reflect the new supplier(s).

For FSIS mailing addresses, which differ depending on the mail service used, see https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-procedures/label-application-guidance.

Export Labeling Chart Now Available

FSIS has posted a new export labeling chart on the FSIS website at: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products.  The export chart provides guidance on when an export label with deviations from domestic requirements needs submission to FSIS for approval per 9 CFR 412.1, and when the label is generically approved per 9 CFR 412.2.  The export chart outlines the actions for different label scenarios.  Additional details on label approval can be found at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling.

Export Requirements Updates

The Library of Export Requirements has been updated for the following countries:

• South Africa
• Hong Kong
• Egypt
• Singapore
• Taiwan

For a complete list of countries, visit https://www.fsis.usda.gov/wps/portal/fsis/ topics/international-affairs/ exporting-products.

Policy Updates 

FSIS notices and directives on public health and regulatory issues are available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations. The following policy updates were recently issued:

• Directive 13000.6 - Actions to Facilitate Industry Access to The Public Health Information System
• Notice 12-19 - Questionnaire for Official Establishments Producing Siluriformes Fish and Fish Products
• Notice 11-19 - Information Regarding Instructional Labeling Statements for Raw Beef Products Shipped to Intermediary Official Establishments Prior to Delivery to an Official Establishment for Full Lethality Treatment to Address Shiga Toxin-Producing Escherichia Coli
• Docket No. FSIS-2018-0039 - The Public Health Information System (PHIS) Export Component Fee
• Docket No. FSIS-2019-0010 - Notice of Requests to Revise an Approved Information Collection