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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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Constituent Update - February 1, 2019

FSIS Welcomes New Deputy Under Secretary for Food Safety

On Jan. 28, 2019, U.S. Secretary of Agriculture Sonny Perdue selected Dr. Mindy Brashears as Deputy Under Secretary for Food Safety. Dr. Brashears is a professor of food safety and public health and the Director of the International Center for Food Industry Excellence at Texas Tech University. Dr. Brashears’ research program focuses on improving food safety standards to make an impact on public health. Her highly acclaimed work evaluates interventions in pre- and post-harvest environments and on the emergence of antimicrobial drug resistance in animal feeding systems. These efforts have resulted in commercialization of a pre-harvest feed additive that can reduce E. coli and Salmonella in cattle. She also leads international research teams to Mexico, Central and South America to improve food safety and security and to set up sustainable agriculture systems in impoverished areas. She is past-Chair of the National Alliance for Food Safety and Security and of the USDA multi-state research group. For more information, visit: https://www.usda.gov/media/press-releases/2019/01/28/perdue-selects-three-senior-leaders-usda.

Label Backlog Update and Tips for the Label Approval Process

FSIS is currently experiencing a delay of 26-29 business days in evaluations for labels that require review prior to use. The agency will provide frequent backlog updates and suggestions via the Constituent Update to assist industry in streamlining label submissions.  By highlighting common mistakes observed during the label evaluation process and providing industry with suggestions for correcting these mistakes, FSIS is hopeful that it will achieve a faster, more efficient label evaluation process and a quicker turnaround of label applications.

TIP: Make All Requested Modifications for Resubmitted Labels. While evaluating labels that are resubmitted for a second review, FSIS has noticed that some establishments are not making all necessary changes requested following the initial label evaluation.  When a label contains numerous errors, or is missing supporting documentation, FSIS returns the label to the submitter with specific information regarding what is needed to get the label approved.  Specifically, this information is noted in the additional comments section of the summary screen in the Label Submission and Approval System (LSAS).  When an establishment disregards any of the feedback provided, the application will likely be returned a second time, resulting in the need for a third label review.  

To help remedy this issue, establishments should: 1) address each comment cited in the additional comments section of the summary screen of LSAS by making the necessary changes to the label as well as responding to each individual issue in the additional comments section; or 2) the establishment may upload a separate document as part of the label application that addresses each issue noted in the additional comment section by FSIS. The speed in which a resubmitted label is reevaluated will increase if each point noted in the additional comments section is addressed by either of the two options.  If an establishment believes that the agency has made a mistake during the evaluation process (e.g., miscalculated the percentage of meat in a product with a minimum meat requirement or overlooked a supporting document that was included in the initial submission), the submitter should note the objection in the additional comments section in LSAS.  If the establishment has additional questions or needs clarification about any of the cited reasons for return of the label, FSIS recommends submitting a question through askFSIS referencing the specific staff officer and 8-digit label application number in the subject line of the inquiry rather than asking follow-up questions in the returned label application.  

FSIS’ User Guide for Industry Users provides guidance on how to use LSAS: https://www.fsis.usda.gov/wps/wcm/connect/45a29f18-52cc-4012-8790-ab7ea9f980c9/LSAS-Industry-User-Guide-063015.pdf?MOD=AJPERES.  Page 112 provides information on reviewing reasons for a label return in LSAS and how to address them. 

FSIS looks forward to working with industry on this issue to facilitate faster turnaround times, fewer label resubmissions, and an overall decreased label backlog. 

Delay in FSIS’ Plans to Discontinue PFGE for E. coli and Move to WGS as the Primary Characterization Tool

FSIS has been performing pulsed-field gel electrophoresis (PFGE) and whole genome sequencing (WGS) in parallel for all bacterial pathogens isolated from FSIS testing programs since fiscal year 2017.  In the Dec. 14, 2018 Constituent Update, FSIS announced the suspension of PFGE for E.coli and Salmonella on Jan. 15, 2019 and March 15, 2019, respectively. However, FSIS is now delaying the suspension of routine PFGE analyses for STEC from Jan. 15, 2019 to March 15, 2019.  The suspension date for PFGE for Salmonella isolates will remain unchanged and will occur on March 15, 2019, as originally announced.  The action is being taken in coordination with federal and public health partners at the Centers for Disease Control and Prevention (CDC) PulseNet network.

Updates to the FSIS Microbiology Laboratory Guidebook

On Nov. 30, 2018, FSIS announced in a Constituent Update its plans to modernize microbiological testing methods at its laboratories. Upon completing a thorough evaluation of commercially available rapid pathogen screening technologies, FSIS laboratories decided to implement a more efficient pathogen detection approach for the identification of Salmonella species, Listeria monocytogenes, and E. coli (STEC) in regulatory samples.

On Jan. 2, 2019, FSIS began using the 3M™ Molecular Detection System for initial screening of regulatory samples for Salmonella and Listeria monocytogenes.  The microbiology laboratory guidebook (MLG) chapters 4 and 8 and their associated appendices were updated to reflect these changes. FSIS also removed optional procedures that FSIS no longer utilized as well as including whole genome sequencing as an option for full laboratory characterization of Salmonella isolates. The previous MLG chapters have been archived and are no longer in effect.

On Feb. 4, 2019, FSIS will begin using the Bio-Rad iQ-Check® system for initial screening of regulatory samples for STEC. The instructions for using this system are contained in a new MLG chapter 5C and associated appendices.  MLG chapters 5, 5A, and 5B and associated appendices will be archived.

The “Notice of Change” page, which is included at the front of each revised or new MLG chapter, provides an overview of the changes made throughout the document.

The FSIS MLG can be found at: https://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/microbiology-laboratory-guidebook/microbiology-laboratory-guidebook

FSIS Posts Individual Category Status and Aggregate Results for Poultry Carcasses, Chicken Parts, and Comminuted Poultry Tested for Salmonella

FSIS has updated the individual establishment Salmonella performance standard category information for raw poultry carcasses, raw chicken parts and comminuted poultry products at: https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/establishment-categories.

Additionally, FSIS will post the aggregate sampling results showing the number of establishments in categories 1, 2, or 3 for establishments producing young chicken or turkey carcasses, raw chicken parts or not ready-to-eat (NRTE) comminuted poultry products at: https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/aggregate-data.

Export Requirements Updates

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

  • Canada
  • Kazakhstan
  • Mexico
  • New Caledonia
  • South Africa
  • Taiwan
  • Western Samoa

Complete information can be found at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products