Constituent Update - October 4, 2019
FSIS Announces Program Leadership Changes
FSIS congratulates Roberta Wagner, Assistant Administrator of the Office of Policy and Program Development (OPPD), on her November retirement from FSIS. Roberta has spent the previous 33 years serving in the federal government.
Roberta began her public service career at the Food and Drug Administration (FDA) in the Office of Regulatory Affairs (ORA) Baltimore District Office in 1987. She worked for FDA for nearly 20 years, first as an analytical chemist and then as Director of the Baltimore District’s Investigations and Compliance branches. Roberta joined FDA’s Center for Food Safety and Applied Nutrition (CFSAN) in 2006, as the Director of the Division of Communication and Education. Roberta provided leadership in designing, and ultimately implementing, FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network. Roberta later served as CFSAN Deputy Director for Regulatory Affairs and Associate Director for Food Safety Modernization Act (FSMA) Operations.
Roberta joined FSIS in 2016 as the Deputy Assistant Administrator, Office of Field Operations; in this capacity she provided direction and support to the thousands of FSIS inspectors and public health veterinarians in the field. She subsequently assumed the agency’s lead policy position where she has been instrumental in moving the agency’s policy forward in line with FSIS’ five-year strategic plan.
Along with Roberta’s retirement, FSIS is announcing related personnel changes, all of which will be effective on October 14, 2019.
Terri Nintemann will be taking Roberta’s place as the new Assistant Administrator of OPPD. Terri has been with FSIS since 2003, and has held various leadership positions throughout the agency, most recently serving as Assistant Administrator of the Office of Planning, Analysis and Risk Management (OPARM). She graduated from the University of Minnesota with a Bachelor of Science degree in Animal Science and a minor in Ag Economics.
Janet Stevens will become the Assistant Administrator of OPARM. Before joining OPARM, Janet served as FSIS’ Chief Information Officer for 11 years, one of the longest serving CIOs in federal government. She graduated from George Mason University with a Bachelor of Arts degree in English with a concentration in Communications.
Nathan Greenwell will be acting as Deputy Assistant Administrator of OPARM. He joined FSIS in 2015 and has been serving as Director of the Data Analysis Staff. Prior to joining OPARM, Nathan was a mathematical statistician for the National Highway Traffic Safety Administration. Nathan graduated from the University of Maryland with a Bachelor of Science degree in Finance and Mathematics.
Establishment-Specific Datasets Now Available
FSIS has posted the quarterly updates to the establishment-specific datasets on the FSIS website:
- Establishment Demographic Data, which supplements the existing MPI Directory
- Ready-to-Eat (RTE) Meat and Poultry Sampling Data
- Egg Product Sampling Data
- Raw Ground Beef Sampling Data
- Raw Beef Trim Sampling Data
- Raw Beef Components Sampling Data
- Raw Beef Follow-up Sampling Data
- Raw Chicken Carcasses Sampling Data
- Raw Turkey Carcasses Sampling Data
- Raw Chicken Parts Sampling Data
- Raw Comminuted Chicken Sampling Data
- Raw Comminuted Turkey Sampling Data
- Raw Poultry Follow-up Sampling Data
It’s important to remember that data contained in the laboratory sampling results datasets on tested product from establishments are not sufficient to determine an association to human illnesses. Further epidemiologic information would be needed to determine if there is an association between the non-clinical isolates and human illnesses.
Additional details can be found at: https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/data/fsis-datasets.
Modification of Raw Pork Products Sampling Program in FY 2020
FSIS has concluded Phase II of its Raw Pork Products Exploratory Sampling Program (RPPESP; FSIS Notice 30-17). The sampling program was conducted to establish the prevalence of Salmonella in pork cuts and comminuted pork products, characterize Shiga toxin-producing E. coli (STEC) in a subset of the samples tested for Salmonella, and inform policy development. FSIS has determined that sufficient laboratory data has been collected during the Phase II of the RPPESP and is moving forward with policy development. Specifically, Salmonella performance standards in raw pork products (intact/non-intact and comminuted) are currently under development and FSIS intends to announce the proposed performance standards in a future Federal Register notice. A summary of results from Phase II can be found on the FSIS webpage at this link. A manuscript describing the findings of Phase II of the Exploratory Sampling Program has been submitted to the Journal of Food Protection for publication, anticipated late 2019.
Due to the low recovery of STEC in samples tested in Phase II of the Raw Pork Products Exploratory Sampling Program, FSIS is entering into a research collaboration with USDA’s Agricultural Research Service (ARS) to continue diagnostics related to STEC in raw pork products sampled by FSIS. For all raw pork products collected after October 7, 2019, FSIS will share sample enrichments with ARS for further analysis of STEC recovery.
Beginning in November 2019, FSIS laboratories will test eligible raw pork products (intact, non-intact and comminuted pork products) for the presence of Salmonella and indicator organisms, under a new sampling plan. Specifically, FSIS will expand sampling to be more inclusive of those official establishments that produce eligible product that FSIS will propose be subject to Salmonella performance standards. Details about the new sampling plan will be announced in a future FSIS notice and Constituent Update.
Release of 2017 Annual Report on the Sources of Foodborne Illness
FSIS In an ongoing effort to understand sources of foodborne illness in the United States, the Interagency Food Safety Analytics Collaboration (IFSAC) collects and analyzes outbreak data to produce an annual report with estimates of foods responsible for foodborne illnesses caused by pathogens. The report estimates the degree to which four pathogens - Salmonella, E. coli O157, Listeria monocytogenes, and Campylobacter – and specific foods and food categories are responsible for foodborne illnesses. The Centers for Disease Control and Prevention (CDC) estimates that, together, these four pathogens cause 1.9 million foodborne illnesses in the U.S. each year. The newest report, entitled “Foodborne illness source attribution estimates for 2017 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States” can be found on the IFSAC website.
The updated estimates, combined with other data, may help shape agency priorities and inform the creation of targeted interventions that can help to reduce foodborne illnesses caused by these pathogens. As more data become available and methods evolve, attribution estimates may improve. These estimates are intended to inform and engage stakeholders and to improve federal agencies’ abilities to assess whether prevention measures are working.
Three federal agencies—the CDC, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) — created IFSAC in 2011 to improve coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use. For more information on IFSAC projects, visit https://www.cdc.gov/foodsafety/ifsac/projects/index.html or email IFSAC@fda.hhs.gov.
Tips for Faster Label Approval Process
FSIS Labels are currently taking about 12-14 business days to evaluate.
TIP: When FSIS approves an animal raising claim on a multi-ingredient product label, that same claim may be applied “generically” to other labels for multi-ingredient products that use meat or poultry from the same producer.
Multi-ingredient product labels bearing animal raising claims, such as “chicken used never administered antibiotics,” require approval from FSIS prior to use and need to be submitted with appropriate documentation to support the specific raising claims. Supporting documentation, e.g., the identification of the producers for the source material used in the product, needs to be submitted to FSIS with the label and then included in the label record once the label has been approved.
Once FSIS approves a raising claim for a particular multi-ingredient product, establishments may apply the same raising claim to other multi-ingredient product labels that use the same livestock or poultry product from the same producer without resubmitting for sketch approval. For example, a beef sausage label sketch approved with a labeling claim of “made with grass-fed beef” could be used to support the same “made with grass-fed beef” for other multi-ingredient products (e.g., beef meatballs and beef chili) that use the same grass-fed beef producer identified in the FSIS approved application. In this case, the use of different ingredients to make meatballs or beef chili will not affect the grass-fed raising claim.
These types of generically approved changes that can be made to labels with special claims that FSIS previously approved are described in greater detail in Appendix 3 of FSIS’ compliance policy guide on label approval (https://www.fsis.usda.gov/wps/wcm/connect/bf170761-33e3-4a2d-8f86-940c2698e2c5/Label-Approval-Guide.pdf?MOD=AJPERES).
This and other useful tips will be discussed during an upcoming webinar on generic labeling and label approval on October 23, at 1:00 p.m. ET. To access the webinar, go to https://fsis-usda.webex.com/join/rosalyn.murphy-jenkins and follow the on-screen instructions. Use the following information when logging in: Meeting Number: 888-844-9904 and Code: 2956126. For questions, contact Gianfranco Santaliz at 301-504-0878 or firstname.lastname@example.org.
FSIS will continue to provide updates regarding label turnaround time, as well as suggestions to assist industry to streamline label submissions in its Constituent Update.
Export Requirements Updates
The Library of Export Requirements has been updated for products for the following countries:
Complete information can be found at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products
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:
FSIS Directive 7120.1 Rev. 52 - Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products
FSIS Directive 9900.3 Revision 1 - Prestamping Imported Product
FSIS Notice 35-19 - Training Requirement For International Travel
Docket No. FSIS-2016-0017 - Modernization of Swine Slaughter Inspection
Docket No. FSIS-2019-0020 - Notice of Request to Renew an Approved Information Collection: Interstate Shipment of Meat and Poultry Product