Constituent Update - October 18, 2013
Label Backlog and Expedited Label Evaluation Procedures
The Agency is aware of the industry’s concern with the increased label backlog during the shutdown. The labeling staff is working hard to review and process labels as quickly as possible. All labels will be logged in on the day they are received by the Labeling and Program Delivery Staff (LPDS). As part of this effort, LPDS recognizes that there may be certain situations where an expedited review is necessary. For the time being, LPDS will only be able to expedite review of labels submitted as an extraordinary circumstance according to the guidance for retained product that requires temporary approval. The guidance can be found at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-procedures/procedures-evaluating-labeling. When product has been retained or “tagged” by program personnel at official establishments or when there is some other unforeseeable impediment to movement of meat or poultry product, and a temporary label approval would remove the impediment (refer to “Information Required For Requesting a Temporary Approval” and 9 CFR 317.4(f) and 381.132(f)), LPDS will expedite label evaluation. To request expedited review, companies should explain why extraordinary circumstances exist and include the information required by regulations for temporary approvals described in the above link.
Over the past two years, LPDS has expedited review of labels that do not meet the criteria listed in the guidance, provided an establishment documented an economic hardship would be incurred if a label approval was not obtained in a certain amount of time. For example, FSIS has expedited review of labels that were submitted for sketch approval, including those that would qualify for generic approval per 9 CFR 317.5 or 381.133, when establishments documented they would incur a financial hardship or loss of business if the label was not evaluated within a certain time period. Prior to the government shutdown and furlough of FSIS employees, labels that are for review were delayed an additional 13 working days. Due to the backlog and volume of labels submitted since our office has reopened, evaluating new labels submitted for expedited review that do not meet the criteria in the guidance before labels submitted prior to the shutdown would push older labels further back in the queue. Consequently, we can no longer expedite label review beyond what is stated in our published guidance, at least until the backlog is eliminated.
Update: FSIS Testing for E. coli
FSIS posts bi-weekly updates for the agency’s raw ground beef E. coli sampling program. Included are testing results of raw ground beef component samples for E. coli O157:H7 and STECs from FSIS routine and follow-up sampling programs. Also featured is data for non-O157 STECs by each non-O157 STEC serogroup. To review testing results, go to http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/ec/testing-program-for-e-coli-o157h7-and-non-o157-stec.
The Library of Export Requirements has been updated to reflect changes in export requirements for the following areas:
- Republic of Korea
Complete information can be found at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products.