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  • Food Safety
    • Recalls & Public Health Alerts
      • Report a Problem with Food
        • Additional Recalls
      • Annual Recall Summaries
        • Summary of Recall and PHA Cases in Calendar Year 2023
        • Summary of Recall and PHA Cases in Calendar Year 2022
        • Summary of Recall Cases in Calendar Year 2021
        • Summary of Recall Cases in Calendar Year 2020
        • Summary of Recall Cases in Calendar Year 2019
        • Summary of Recall Cases in Calendar Year 2018
        • Summary of Recall Cases in Calendar Year 2017
        • Summary of Recall Cases in Calendar Year 2016
        • Summary of Recall Cases in Calendar Year 2015
        • Summary of Recall Cases in Calendar Year 2014
        • Summary of Recall Cases in Calendar Year 2013
        • Summary of Recall Cases in Calendar Year 2012
    • Food Safety Stats
      • Consumer Research
    • Foodborne Illness and Disease
      • Enfermedades Transmitidas Por Alimentos y Otras Enfermedades
      • Illnesses and Pathogens
        • Botulism
          • Clostridium botulinum y El Botulismo
        • Campylobacter
          • Campylobacter En Español
        • E. coli
        • Listeria
        • Parasites and Foodborne Illness
          • Parásitos y Enfermedades Transmitidas Por los Alimentos
        • Preguntas y Respuestas Sobre Listeria
        • Salmonella
          • Preguntas y Respuestas Sobre Salmonella
      • Resources for Public Health Partners
        • State Departments of Public Health
      • Outbreaks
        • Outbreak Investigations: Prevention
        • Outbreak Investigations: Response
    • Safe Food Handling and Preparation
      • Food Safety Basics
        • Additives in Meat and Poultry Products
        • Aditivos en Productos Cárnicos y Avícolas
        • Agua en Carnes y Aves
        • Ahumar Carnes y Aves
        • Air Fryers and Food Safety
        • Alergias Alimentarias: Los “9 Grandes”
        • Appliance Thermometers
        • Asar a la parrilla y seguridad alimentaria
        • Cleanliness Helps Prevent Foodborne Illness
        • Cocción Versus Seguridad
        • Cocinar en Hornos Microondas
        • Cooking for Groups
        • Cooking with Microwave Ovens
        • Cutting Boards
        • Cómo Encontrar el Número de Establecimiento del USDA (EST) en el Empaque de Alimentos
        • Cómo las Temperaturas Afectan a los Alimentos
        • Danger Zone 40F - 140F
        • Deep Fat Frying
        • Doneness Versus Safety
        • El Color de la Carne y Las Aves
        • El Gran Deshielo: Métodos Seguros para Descongelar
        • El Manejo Adecuado de los Alimentos Pedidos Por Correo
        • Entendiendo las Retiradas de Alimentos del Mercado del FSIS
        • Fechas en Productos Alimenticios
        • Food Allergies: The “Big 9”
        • Food Thermometers
        • Freidoras de Aire y Seguridad Alimentaria
        • Freír en Grasa y Seguridad Alimentaria
        • Glosario de Términos de Empaque
        • Glossary of Packaging Terms
        • Grilling Food Safely
        • Grilling and Food Safety
        • Guía del Consumidor Sobre Inocuidad Alimentaria: Tormentas y Huracanes Severos
        • High Altitude Cooking
        • Hongos en los Alimentos: ¿Son Peligrosos?
        • How Temperatures Affect Food
        • How to Find the USDA Establishment Number
        • Importación de Productos Cárnicos, Avícolas y Ovoproductos a Estados Unidos
        • Importing Meat, Poultry & Egg Products US
        • Irradiation and Food Safety FAQ
        • Keeping "Bag" Lunches Safe
        • Keeping Food Safe During an Emergency
        • La Cocción En Elevaciones Altas
        • La Congelación Y Seguridad Alimentaria
        • La Limpieza Ayuda a Prevenir Enfermedades Transmitidas Por Los Alimentos
        • Las Ollas de Cocción Lenta y la Seguridad Alimentaria
        • Las Sobras de Comida e Inocuidad Alimentaria
        • Lavado de Alimentos: ¿Promueve la Inocuidad Alimentaria?
        • Mail Order Food Safety
        • Manipulación Adecuada de Alimentos Para Llevar
        • Mantenga los Alimentos Seguros - Conceptos Básicos de Inocuidad Alimentaria
        • Manteniendo Seguros Los Almuerzos En "Bolsas"
        • Materiales de Empaque para Carnes y Aves
        • Meat and Poultry Labeling Terms
        • Meat and Poultry Packaging Materials
        • Molds on Food: Are They Dangerous?
        • Natural Flavors on Meat and Poultry Labels
        • Preguntas Frecuentes Sobre Irradiación y Seguridad Alimentaria
        • Preguntas y Respuestas Sobre la Seguridad Alimentaria Durante un Tailgate
        • Sabores Naturales de Carnes y Aves en las Etiquetas
        • Safe Handling of Take-Out Foods
        • Seguridad Alimentaria Durante Caminatas, Campamentos y Paseos en Bote
        • Seguridad Alimentaria de Comida No Perecedera
        • Slow Cookers and Food Safety
        • Smoking Meat and Poultry
        • Tabla de Temperatura Interna Mínima Segura
        • Tablas de Cortar
        • Tailgating Food Safety Q & A
        • Termómetros para Alimentos
        • Termómetros para Electrodomésticos
        • Términos de Etiquetado de Carnes y Aves
        • Understanding FSIS Food Recalls
        • Voluntarios Sobre la Seguridad Alimentaria
        • Water in Meat & Poultry
        • Zona de Peligro (40 F - 140 F)
        • Food Product Dating
        • Freezing and Food Safety
        • Leftovers and Food Safety
        • Refrigeration
          • La Refrigeración y Seguridad Alimentaria
        • Safe Temperature Chart
        • Shelf-Stable Food
        • The Big Thaw — Safe Defrosting Methods
        • The Color of Meat and Poultry
        • Washing Food: Does it Promote Food Safety?
        • Food Safety While Hiking, Camping & Boating
      • Meat & Catfish
        • Bacon and Food Safety
        • Bagre de la Granja a la Mesa
        • Beef From Farm To Table
        • Bison from Farm to Table
        • Bisonte de la Granja a la Mesa
        • Cabra de la Granja a la Mesa
        • Carne Seca y Seguridad Alimentaria
        • Carne de Cerdo Fresca de la Granja a la Mesa
        • Carne de Res de la Granja a la Mesa
        • Carne de Ternera de la Granja a la Mesa
        • Carne de res ablandada mecánicamente
        • Carne en Conserva y Seguridad Alimentaria
        • Catfish from Farm to Table
        • Color de la Carne Molida Cocida en Relación Con El Grado De Cocción
        • Color of Cooked Ground Beef as It Relates to Doneness
        • Conejo de la Granja a la Mesa
        • Cordero de la Granja a la Mesa
        • Corned Beef
        • Cuando se Asan “Otras” Carnes para las Fiestas
        • Door-to-Door Meat Sales
        • El Jamón y la Seguridad Alimentaria
        • El Tocino y la Seguridad Alimentaria
        • Fresh Pork from Farm to Table
        • Goat from Farm to Table
        • Ground Beef and Food Safety
        • Hams and Food Safety
        • Hot Dogs & Food Safety
        • Jerky
        • La Carne Molida y la Seguridad Alimentaria
        • Lamb From Farm to Table
        • Las Salchichas “hot dogs” y la Seguridad Alimentaria
        • Los Embutidos y Seguridad Alimentaria
        • Mechanically Tenderized Beef
        • Rabbit From Farm to Table
        • Roasting Those "Other" Holiday Meats
        • Sausages and Food Safety
        • Veal from Farm to Table
        • Venta de Carne a Domicilio
        • Yersiniosis and Chitterlings Tips
        • Yersiniosis y los Chinchulines (Tripas): Consejos Para Protegerlo de Enfermedades Transmitidas Por Alimentos
      • Poultry
        • Happy Thanksgiving!
        • Amarras para las Aves y Otros Accesorios
        • Aves: Baños en Solución, Salmueras y Marinadas
        • Chicken From Farm to Table
        • Chicken Liver
        • Duck and Goose from Farm to Table
        • El Relleno y Seguridad Alimentaria
        • Hablemos Sobre el Pavo: Una Guía Para el Consumidor Sobre Cómo Asar un Pavo de Forma Segura
        • Hock Locks and Other Accoutrements
        • Is Pink Turkey Meat Safe?
        • La Etiqueta del Ave Dice “Fresco”
        • La Preparación de Turduckens Requiere un Manejo Adecuado
        • Let's Talk Turkey Roasting
        • Pato y Ganso de la Granja a la Mesa
        • Pavo de la Granja a la Mesa
        • Pavo: Rutas Alternativas Hacia la Mesa
        • Pollo de la Granja a la Mesa
        • Poultry Processing: Questions & Answers
        • Poultry: Basting, Brining, and Marinating
        • Preparación Básica del Pavo: Cocinar De Forma Adecuada
        • Preparación Básica del Pavo: Como Descongelar Seguramente
        • Preparación Básica del Pavo: El Relleno
        • Preparación Básica del Pavo: Manejo de las Comidas Cocidas
        • Procesamiento de Aves: Preguntas y Respuestas
        • Stuffing and Food Safety
        • The Poultry Label Says "Fresh"
        • Turduckens Require Safe Food Handling
        • Turkey Basics: Handling Cooked Dinners
        • Turkey Basics: Safe Cooking
        • Turkey Basics: Safe Thawing
        • Turkey Basics: Stuffing
        • Turkey from Farm to Table
        • Turkey: Alternate Routes to the Table
        • ¿Es Segura la Carne de Pavo Rosada?
      • Eggs
        • Egg Products and Food Safety
        • Huevos en Cascarón De la Granja a la Mesa
        • Ovoproductos e Inocuidad Alimentaria
        • Shell Eggs from Farm to Table
      • Emergencies
        • A Consumer's Guide to Food Safety: Severe Storms and Hurricanes
        • Eliminando Olores de Refrigeradores y Congeladores
        • Fires and Food Safety
        • Incendios y Seguridad Alimentaria
        • Keep Your Food Safe During Emergencies
        • Removing Odors from Refrigerators and Freezers
      • USDA Meat and Poultry Hotline
      • Brochures & Publications
    • Food Defense and Emergency Response
      • Emergency Response
      • Continuity of Operations (COOP)
      • Food Defense
        • Risk Mitigation Tool
        • Food Defense Considerations for Transportation of FSIS-Regulated Products
        • Food Defense Tools, Resources and Training
        • Functional Food Defense Plans
        • International Food Defense
  • Science & Data
    • Research Priorities
      • FSIS/ORISE Food Safety Fellowship Program
        • Aaron Dudley
        • Lauren Lee
        • Sharon Nieves-Miranda
        • Yesutor Soku
        • Ali Strickland
    • Data Sets & Visualizations
      • Microbiology
        • Baseline Microbiology Data Reports
        • Microbiological Testing Program for RTE Meat and Poultry Products
          • Tables & Results Microbiological Testing Program for RTE Meat
          • Tables & Results: Microbiological Testing Program Pasteurized Egg Products
          • Aggregate Salmonella Categorization of Raw Chicken Parts, NRTE Comminuted Poultry, Young Chicken Carcass and Young Turkey Carcass Establishments Using Moving Windows
          • Salmonella Initiative Program Criteria
            • Quarterly Sampling Reports on Antimicrobial Resistance
            • Quarterly Sampling Reports on Raw Beef Products
            • Quarterly Sampling Reports on Ready-to-eat Products and Egg Products
            • Quarterly Sampling Reports on Salmonella
            • Salmonella Action Plan: A One and Two Year Update
        • Microbiological Testing Program for Escherichia coli O157:H7 and non-O157 Shiga toxin-producing Escherichia coli (STEC)
          • Year-to-Date Totals: Testing of Raw Ground Beef Component (RGBC) Samples for E. coli O157:H7 and non-O157 Shiga toxin-producing E. coli (STEC)
          • Annual Report for STEC in Raw Ground Beef or Veal and Raw Ground Beef or Veal Components
          • Individual E. coli Positive Results for Raw Ground Beef (RGB) and RGB Components 2017
          • Individual E. coli Positive Results for Raw Ground Beef (RGB) and RGB Components 2018
          • Individual E. coli Positive Results for Raw Ground Beef (RGB) and RGB Components 2016
          • Individual E. coli Positive Results for Raw Ground Beef (RGB) and RGB Components 2015
          • Year-to-Date 2018 Totals: Results of Raw Ground Beef Component (RGBC) Samples for E. coli O157:H7 and non-O157 Shiga toxin-producing E. coli (STEC):
        • Salmonella Verification Testing Program Monthly Posting
      • Chemical Residues and Contaminants
      • Humane Handling Data
      • Laboratory Sampling Data
        • Egg Product Testing, Years 1995-2017
      • Inspection Task Data
    • Developer Resources
      • Recall API
    • Scientific Reports
      • Public Health Regulations (PHR)
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2025
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2024
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2023
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2022
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2021
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2020
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2019
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2018
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2017
        • FSIS Data Analysis and Reporting: Public Health Regulations FY 2016
      • Interagency Food Safety Analytics Collaboration (IFSAC)
    • Laboratories & Procedures
      • Accredited Laboratory Program
        • Key Facts: ISO Accreditation
      • FSIS Laboratories
        • Requesting Bacterial Isolates from FSIS
    • Risk Assessments
    • Sampling Program
      • Raw Pork Products Exploratory Sampling Program
      • Sampling Results for FSIS Regulated Products
    • National Antimicrobial Resistance Monitoring System (NARMS)
    • Journal Publications
  • Policy
    • Food Safety Acts
      • Federal Meat Inspection Act
      • Poultry Products Inspection Act
      • Egg Products Inspection Act
      • Humane Methods of Slaughter Act
    • FSIS Guidelines
    • Directives & Notices
      • FSIS Notices
      • FSIS Directives
    • Petitions
    • Federal Register & Rulemaking
      • Federal Register Notices
      • Federal Register Rules
      • Executive Orders, Small Business Protection Laws & Other Guidance
      • Regulatory Priorities
    • Advisory Committees
      • National Advisory Committee on Meat and Poultry Inspection (NACMPI)
      • National Advisory Committee on Microbiological Criteria For Foods (NACMCF)
        • 2023-2025 National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
        • 2021-2023 National Advisory Committee on Microbiological Criteria For Foods (NACMCF)
        • NACMCF 2022 Subcommittee
        • 2018-2020 National Advisory Committee on Microbiological Criteria For Foods (NACMCF)
    • FSIS Procurement
    • National Federal Financial Assistance
    • Regulatory Decisions & Non-Retaliation
  • Inspection
    • Inspection Programs
      • Inspection of Meat Products
        • Humane Handling Ombudsman
        • Modernization of Swine Slaughter Inspection
      • Inspection of Poultry Products
        • Reducing Salmonella in Poultry
          • Pilot Projects: Salmonella Control Strategies
          • Proposed Regulatory Framework to Reduce Salmonella Illnesses Attributable to Poultry
            • Component 1
            • Component 2
            • Component 3
          • Salmonella By the Numbers
          • Salmonella KPI
          • Salmonella Risk Assessments
        • Modernization of Poultry Slaughter Inspection
      • Inspection of Egg Products
      • Inspection of Siluriformes
    • Compliance Guidance
      • Significant Guidance
      • HACCP
        • HACCP-Based-Inspection Models Project
          • New Poultry Inspection System (NPIS)
          • HIMP Redesign Achievement of Performance Standards Young Chicken Plants
          • List of HIMP Participating Plants
        • HACCP Validation
      • PHIS
        • PHIS: Historical Information
      • Retail Guidance
      • Small & Very Small Plant Guidance
        • Appealing Inspection Decisions
        • Food Safety Resources for Small and Very Small Plant Outreach: Order Form
        • Small Plant Help Desk
        • Small Plant Help Desk Form
      • Microbial Risk
        • Listeria Monocytogenes
        • Salmonella
        • Shiga Toxin-Producing E.Coli (STEC) and E. Coli O157:H7
        • Specified Risk Material
          • BSE Rules Being Strictly Enforced
            • BSE Workshops for Small & Very Small Plants
          • FSIS BSE Resources
      • Specified Risk Material Resources
      • Food Safety Assessments Tools
      • Recall Process
      • Sanitation Performance Standards Compliance Guide
      • Labeling
        • Basics of Labeling
        • Claims Guidance
        • Nonfood Compounds
          • Compounds Used for Construction and Repair in Federally Inspected Meat and Poultry Plants
          • Criteria Used by the Former Compounds and Packaging Branch for Evaluating Nonfood Compounds and Proprietary Substances
        • Ingredients Guidance
        • Label Submission and Approval System (LSAS)
          • Integration of Paper Label Applications into the Label Submission and Approval System (LSAS)
        • Labeling Policies
          • Human Food Made with Cultured Animal Cells
          • Regulations for Package Dating
          • Comprehensive List of Reasons for Label Modifications and Returns
        • Labeling Procedures
          • Information Required For Requesting a Temporary Approval
          • 10 Most Common Mistakes And How to Avoid Them
          • Label Submission Checklist
          • Labeling Situations That Can Not Have a Temporary Approval
          • Labeling and Establishment Responsibilities
          • Ten Most Commonly Asked Labeling Questions
          • Trans Fat Declarations in the Nutrition Facts Panel on Product Labeling
      • New Technology
        • Cooperative Agreements FY 2003
        • Cooperative Agreements FY 2004
        • Cooperative Agreements FY 2005
        • Food Safety Technologies FY 2003
        • Food Safety Technologies FY 2004
        • Food Safety Technologies FY 2005
        • NOL for Non-O157 STEC Test Methods
        • New Technology Information Table
      • Humane Handling
    • Import & Export
      • Import & Export Library
        • Eligible Foreign Establishments
        • Eligible U.S. Establishments by Country
          • Australia Eligible Establishments
          • Hong Kong Lamb Export Eligible Establishments
          • Hong Kong Pork Export Eligible Establishments
          • Hong Kong Poultry Export Eligible Establishments
          • Brazil Export Eligible Establishments
          • Egypt Export Eligible Establishments
          • Hong Kong Beef Export Eligible Establishments
          • Israel Export Eligible Establishments
          • Japan (Casings) Export Eligible Establishments
          • Japan (Cold Storage Facilities) Export Eligible Establishments
          • Mexico Export Eligible Establishments
          • Russia (Beef) Export Eligible Establishments
          • Russia (Pork) Export Eligible Establishments
          • Russia (Poultry) Export Eligible Establishments
          • Russia (Prepared Products) Export Eligible Establishments
          • South Africa Eligible Establishments
      • Import Guidance
        • FSIS Import Procedures for Meat, Poultry & Egg Products
        • FSIS Import Reinspection
        • Sourcing Egg Products and Shell Eggs From Foreign Countries
      • Export Guidance
      • Equivalence
      • PHIS Components
      • International Reports
        • Foreign Audit Reports
        • Import and Export Data
    • Regulatory Enforcement
      • Humane Handling Enforcement
      • Quarterly Enforcement Reports
    • Inspection Training & Videos
      • Humane Interactive Knowledge Exchange (HIKE) Scenarios
      • Inspection & Mission Training
      • Meat, Poultry and Egg Product Inspection Videos
      • Regulatory Education Video Seminars
    • Apply for Grant of Inspection
      • Grants & Financial Options
    • State Inspection Programs
      • Cooperative Interstate Shipping Program
        • Cooperative Interstate Shipment (CIS) Establishments
      • Guidance Documents for State and Local Agencies
      • States With and Without Inspection Programs
      • Reviews of State Programs
    • Establishments
      • FSIS Inspected Establishments
      • Meat, Poultry and Egg Product Inspection Directory
    • Inspection Forms
  • About FSIS
    • History
    • Leadership & Organizational Structure
    • Strategic Planning
      • FSIS Enterprise Governance Decision Making Process
    • Core Values
    • Food Safety & Agency Partners
      • Memoranda of Understanding (MOU)
    • Freedom of Information Act (FOIA)
      • FSIS Adjudications
      • FSIS FOIA Reading Room
      • Frequently Requested Records
    • Federal Employee Viewpoint Survey (FEVS)
  • Contact Us
    • FSIS Offices
      • Office of Food Safety (OFS)
      • Office of the Administrator (OA)
      • Office of Field Operations (OFO)
      • Office of Investigation, Enforcement and Audit (OIEA)
      • Office of Public Health Science (OPHS)
      • Office of Policy and Program Development (OPPD)
      • Office of the Chief Financial Officer (OCFO)
      • Office of International Coordination (OIC)
      • Office of Employee Experience and Development (OEED)
      • Office of the Chief Information Officer (OCIO)
      • Office of Management (OM)
      • Office of Public Affairs and Consumer Education (OPACE)
      • Internal Affairs (IA)
      • Office of Planning Analysis Risk Management (OPARM)
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    • Apply for a Job
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      • Professional Positions
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    • Who Works for Us
      • Stephanie Galvan Prioritizes Excellence in FSIS
      • Yolanda Kennedy-Edwards: Compassion and Continuous Improvement to Catapult Change
      • Arsalan “AJ” Jalisi Enhances Decision-Making and Engagement with Data Analytics
      • Archives
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    • Agency Awards & Achievements
      • 2024 Under Secretary’s Awards and Administrator’s Awards for Excellence Ceremony
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      • FSIS Snapshots
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      • Submit Your Stories
      • Archives
        • ARCHIVE: Professional Development and Education Benefits as a Recruitment Tool
        • ARCHIVE: Improved PHIS Task Distributor Comes Online!
        • ARCHIVE: Reflections on a Changing Paradigm: World Veterinary Day
        • ARCHIVE: FSIS at Congressional Black Caucus Foundation Conference
        • ARCHIVE: The Power of Alternative Dispute Resolution Programs: Resolving Workplace Conflicts Efficiently
        • ARCHIVE: Third FSIS International Meat, Poultry and Egg Products Inspection Seminar Held in Santiago, Chile
        • ARCHIVE: Supervisors Make All the Difference!
        • ARCHIVE: National Preparedness Month — Workplace Violence: Active Shooter
        • ARCHIVE: National Preparedness Month - Cyber Security for Remote Work
        • ARCHIVE: National Preparedness Month: Occupant Emergency Planning
        • ARCHIVE: National Preparedness Month: Emergency Alerts
        • ARCHIVE: Managing Heat Risk in Hot Weather
        • ARCHIVE: New Netflix Show Features USDA and FSIS
        • ARCHIVE: Thank You for Your Public Service
        • ARCHIVE: World Veterinary Day — Recognizing the Resilience of FSIS Veterinarians
        • ARCHIVE: Two Hero Inspectors Provide Potentially Life-Saving CPR to a Plant Employee
        • ARCHIVE: Hero Inspector Saves a Life While on the Road
        • ARCHIVE: Administrative Professionals Day — Thank You
        • ARCHIVE: Chief Information Security Officer Marvin Lykes Recognized for Operational Excellence
        • ARCHIVE: Alameda District Awards Petaluma Circuit Inspectors Recognition Coins
        • ARCHIVE: Collaborating in the Caribbean — Bringing Awareness About African Swine Fever
        • ARCHIVE: Dearborn, Mich., Circuit Inspectors Receive Collaborative Coins
        • ARCHIVE: Don’t Invite Foodborne Illness to the Party
        • ARCHIVE: Inspection for Ritual Meat and Poultry Slaughter
        • ARCHIVE: Thanksgiving Message from Leadership
        • ARCHIVE: Make a Difference for You and Your Colleagues – Respond to FEVS by Dec. 3
        • ARCHIVE: Federal State Audit Staff Twice Honored for Supporting Military Staff
        • ARCHIVE: Veterans Day Messages from FSIS Leadership
        • ARCHIVE: Food Inspector Apprenticeship Programs for Veterans
        • ARCHIVE: Helping Today’s Inspectors Be Tomorrow’s Leaders with Tuition Reimbursement
        • ARCHIVE: National Preparedness Month – Home Go Kits & Pets
        • ARCHIVE: Modernizing Egg Inspection
        • ARCHIVE: FSIS Recognized Twice for 2020 Food Safety Education Efforts
        • ARCHIVE: Four Steps to Good Mental Health
        • ARCHIVE: Building Relationships at Work
        • ARCHIVE: Honoring the Dedicated Public Servants of FSIS
        • ARCHIVE: Remembering Their Sacrifice: Jean Hillery, Tom Quadros and Bill Shaline
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Food Safety and Inspection Service

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Ongoing Verification of Product Formulation and Labeling Targeting the Nine Most Common ("Big 9") Food Allergens - Revision 3

FSIS directive 7230.1
Series Type 7000 Series: Processed Products
Issue Date Jan 16, 2024
Full Directive
7230.1.pdf
  1. PURPOSE
    This directive provides instructions to inspection program personnel (IPP) for performing the "Big 9" Formulation Verification task in the Public Health Information System (PHIS). IPP verify that establishments are accurately controlling and labeling the nine most common ("Big 9") food allergens in meat (including Siluriformes products), poultry, and egg products establishments. These allergens are designated as "major food allergens" by the Food and Drug Administration's (FDA) Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 and Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) of 2021. FSIS is reissuing this directive in its entirety to add sesame as the ninth major food allergen, clarify that the milk allergen is "cow's milk," and include an additional example for soy products.
  2. CANCELLATION
    FSIS Directive 7230.1, Revision 2, Ongoing Verification of Product Formulation and Labeling Targeting the Eight Most Common ("Big 8") Food Allergens, 9/26/18
  3. BACKGROUND
    1. Effective Jan. 1, 2023, the FASTER Act expanded the definition of a "major food allergen" to include sesame. Therefore, the "Big 9" food allergens account for approximately 90 percent of all food allergy reactions. The "Big 9" food allergens are:
      1. Wheat;
      2. Crustacean shellfish (e.g., crab, lobster, shrimp);
      3. Eggs;
      4. Fish;
      5. Peanuts;
      6. Milk;
      7. Tree nuts (e.g., almonds, pecans, walnuts);
      8. Soybeans; and
      9. Sesame.
    2. FSIS analyses of previous instructions to the field and establishment voluntary recalls of product connected to undeclared allergens revealed that misbranding usually occurred due to changes in ingredient suppliers, products in the wrong package or with misprinted labels, or changes to a product or ingredient formulation.
    3. An FSIS analysis of establishment voluntary recalls revealed products with other misbranding issues also failed to include allergens on the product label when a meat or poultry product came in contact with an undeclared allergenic ingredient that was not directly added to the product.
    4. When an establishment ships product into commerce with an undeclared allergen, its food safety system has failed to control the chemical hazards associated with allergens. For an establishment producing meat or poultry products, the establishment has either failed to address the chemical (allergen) food safety hazard in its Hazard Analysis and Critical Control Point (HACCP) plan, failed to support the decisions made in its hazard analysis, or failed to effectively implement the controls to support the decisions made in the hazard analysis.
    5. It is important that establishments have preventive measures or controls in place to address undeclared food allergens. When "Big 9" food allergens or other ingredients are not properly declared, FSIS may request the establishment voluntarily recall the affected product (refer to FSIS Directive 8080.1, Recall of Meat and Poultry Products, for additional information on recall procedures).
    6. This directive applies to meat and poultry product establishments that produce products other than single ingredient products or those that have a combination of only meat or poultry ingredients. in the following HACCP categories:
      1. Raw - non-intact;
      2. Raw - intact;
      3. Thermally processed commercially sterile;
      4. Not heat treated, shelf stable;
      5. Heat treated shelf stable;
      6. Fully cooked not shelf stable;
      7. Heat treated not fully cooked not shelf stable; and
      8. Product with secondary inhibitors not shelf stable.
  4. IPP RESPONSIBILITIES
    1. IPP are to inform the establishment at the next weekly meeting following issuance of Revision 3, that the Establishment Profile Report has been updated to identify whether "Big 9" allergens are used in product formulations based on the response to Question 1 in the task questionnaire.
    2. When there are potential allergen labeling regulatory concerns, and with all new establishments, IPP are to meet with establishment management to discuss the items in the Background (Section III) of this directive. IPP are to:
      1. Verify in advance of the meeting whether the establishment has developed and implemented preventive or control measures within its HACCP plan, Sanitation Standard Operating Procedures, or other prerequisite program to address allergens;
      2. Discuss with the establishment any products that contain any of the "Big 9" food allergens. Refer them to Attachment 1, which lists examples of ingredients and products that may be derived from or contain these food allergens;
      3. Inform establishment management that IPP will continue to verify that the establishment's labels match its product formulations during an ongoing "Big 9" Formulation Verification task occurring at a monthly frequency. IPP are to schedule additional verification tasks (directed) in response to FSIS concerns in accordance with Section V.B. of this directive; and
      4. Inform establishment management that FSIS allergen and labeling guidelines are available online, which may assist them in assessing their own allergen program.
    3. IPP are to conduct the assigned "Big 9" Formulation Verification task and document findings in PHIS as directed in Section VI of this directive.
  5. TIMING OF VERIFICATION ACTIVITIES
    1. Each meat, poultry, or egg products establishment that produces product in the HACCP categories listed in Section III. F. of this directive will continue to be assigned a routine "Big 9" Formulation Verification task in PHIS on a monthly basis.
    2. If IPP receive the "Big 9" Formulation Verification task in establishments that produce single ingredient products or they only combine various species of meat or poultry products, they are to cancel the task per FSIS Directive 13000.1, Scheduling In-Plant Inspection Tasks in the Public Health Information System (PHIS). Refer to FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System (PHIS) for information on how to view or edit the establishment task list in the PHIS profile.
    3. In addition to the routine "Big 9" Formulation Verification task, IPP may schedule a directed "Big 9" Formulation Verification task more frequently in an establishment if there are indicators of an increased risk of undeclared allergens. IPP are to discuss these concerns with their immediate supervisor and frontline supervisor (FLS) and select the reason for the directed task as appropriate. IPP are to consider the situations below when considering whether they need to schedule additional "Big 9" Formulation Verification tasks:
      1. A recall by the establishment related to "Big 9" allergens, ingredients of public health concern, or other undeclared ingredients;
      2. Consumer complaints linked to the establishment related to allergens, ingredients of public health concern, or other undeclared ingredients;
      3. A history of sanitation Noncompliance Records (NRs), and HACCP NRs for meat and poultry establishments, related to allergens, ingredients of public health concern, or other undeclared ingredients;
      4. A history of labeling NRs for the establishment; or
      5. Recent product formulation changes, adjustments to ingredients, supplier changes, or new products added by the establishment.
    4. IPP are to contact their immediate supervisor and FLS for guidance if at any time they have reason to believe product bearing labels that fail to declare one of the "Big 9" food allergens has entered commerce (refer to FSIS Directive 8080.1).
  6. "BIG 9" FORMULATION VERIFICATION TASK
    1. IPP are to perform the "Big 9" Formulation Verification task at the frequency assigned in PHIS.
    2. IPP are to determine which products will be produced on the date they have planned and scheduled the routine task.
    3. IPP are to select one product, which they perceive may or may not contain an allergen, for the "Big 9" Formulation Verification task. IPP in establishments with multiple shifts are to complete the verification task on each shift and are to coordinate with each other to avoid selecting the same product for a "Big 9" Formulation Verification task.
    4. IPP are not to select the same product for consecutive "Big 9" Formulation Verification tasks and are to, where possible, first select products that have not been selected previously for this task; exceptions would include repeating the tasks for products associated with a change in supplier, change in ingredients, change in formulation, or if the establishment produces a very limited number of products.
    5. IPP are to apply the prioritization flow chart to all products and eligible establishments as per Section III.F. of this directive regardless of whether they produce products containing a "Big 9" allergen.

      (Graphic on page 5 of directive.)

      NOTE: Examples of multi-ingredient components include sauces, condiments such as ketchup or mustard, seasoning packets, flavorings, spice mixes, soup bases, or other combinations of two or more ingredients that are mixed together (in this case, outside of the establishment).
    6. IPP are to obtain the formulation for the product selected for the task from the establishment after completing the product prioritization and selection process. The product formulation is to be specific to the actual product, not a general formula.
      1. Meat, poultry and egg establishments are required to provide IPP accurate information on all procedures involved in product preparation, including product composition, for verification in accordance with 9 CFR 318.6, 381.180, and  9 CFR 590.411.
    7. IPP are to perform the "Big 9" Formulation Verification task using the record review and observation component for the production of the product selected using the product prioritization flow chart in this section of this directive. IPP are to verify that:
      1. All ingredients used in the production of the product are present on the product formulation record (through Record Review and Observation);
      2. All ingredients in the product formulation are declared in the ingredients statement on the product label by common or usual name in descending order of predominance and that the appropriate label is applied to the product (through Record Review and Observation); and
      3. The applied label is consistent with the establishment's label approval on file (through Record Review).
    8. IPP are to use the list of common ingredients and foods in Attachment 1 of this directive for help in identifying "Big 9" allergens.
    9. IPP are to answer specific questions related to the "Big 9" Formulation Verification task in PHIS. These questions can be accessed from the "questionnaire" tab of the task. See Attachment 2 of this directive for questions, answer choices, and related guidance. IPP are to be aware that if they select one or more of the "Big 9" allergens in response to Question 1, the Establishment Profile Report will automatically populate this field within 30 days of completing the task to reflect that the establishment uses "Big 9" allergens in its product formulation.
    10. IPP are not required to, nor able to, edit the "Big 9" allergens field in the Establishment Profile Report.
    11. IPP are to perform direct observation to verify that all ingredients used in a product formulation are appropriately declared on the final meat, poultry, or egg product labels.
      1. IPP are to verify that all ingredients listed on the labels of incoming food and food ingredients (e.g., multi-ingredient components such as sauces or seasoning packets) are listed on the labels of the meat, poultry, or egg products in which they are used.
        1. Ingredients classified as spices and flavoring may be declared under the general declaration of "spices" or "flavoring";
        2. Except under limited circumstances, the label does not need to declare substances that FSIS has determined meet the definition of a processing aid or incidental additive. However, substances that would normally be considered processing aids or incidental additives that are derived from allergens (e.g., soy) are exceptions and must be declared on labels; and
        3. As a rule, releasing agents applied to food contact surfaces used to prevent sticking of foods are considered processing aids. However, the label must declare the releasing agents that contain food allergens (e.g., soy) in the ingredients statement.
        NOTE: 21 U.S.C. 343(w)(6) provides for a petition process administered by FDA by which companies may request exemption for the declaration requirement for processing aids that contain food allergens. To date, only soy lecithin release agents produced by Archer Daniels Midland and Solae have been exempted from declaration. All other soy lecithin products must be declared by common and usual name in the ingredient statement. If IPP are unsure if an ingredient meets the definition of a processing aid, incidental additive or release agent or if an ingredient used as a processing aid, incidental additive or release agent is required to be declared in the ingredients statement on the product label, they should submit a question to the Labeling and Program Delivery Staff via askFSIS.
      2. IPP are to verify that all of the ingredients listed in a "may contain" or "produced in a facility" statement on incoming food and food ingredients are listed on the final product label, except in situations where the establishment contacts the supplier of the component and addresses the statement. Establishments producing meat and poultry products would address the statement in the hazard analysis. Specifically, all the ingredients in a "may contain" or "produced in a facility" statement of a purchased ingredient need not be listed on the final label if the official establishment conducts both of the following:
        1. Contacts the supplier and confirms in writing that the statement is a cautionary statement, and no such ingredient is in the product; and
        2. Includes a written statement in its hazard analysis documentation to support why the "may contain" or "produced in a facility" statement is not carried forward to the finished meat or poultry product label.
  7. "BIG 9" FORMULATION VERIFICATION NONCOMPLIANCE
    1. IPP are to record any noncompliance identified on an NR according to FSIS Directive 5000.1, Verifying an Establishment's Food Safety System. IPP in egg products establishments are to follow the instructions in FSIS Directive 5030.1, Labeling and Import Verification in an Official Egg Products Plant.
    2. If IPP identify an undeclared allergen, they are to cite both the relevant hazard analysis and labeling regulations. IPP are to notify their immediate supervisor if they identify a noncompliance during the "Big 9" Formulation Verification task. Examples of potential noncompliance that warrant the issuance of a NR are:
      1. Hazard Analysis:
        1. If during the course of conducting the verification task, IPP find that a meat, poultry or egg product contains an undeclared allergen, and the establishment has not identified the allergen or allergen-containing ingredient as a chemical hazard in its hazard analysis, IPP are to document the noncompliance in a NR. IPP are to cite 9 CFR 417.2(a)(1) as the relevant regulation because the establishment failed to address a chemical food safety hazard in its process. IPP are also to verify that the establishment has implemented corrective actions that meet the requirements of 9 CFR 417.3(b) in response to the unforeseen hazard and are to document noncompliance in a NR;
        2. If during the course of conducting the verification task, IPP find that a meat, poultry or egg product contains an undeclared allergen, and the establishment has identified the allergen as a chemical hazard in its hazard analysis and determined it is not reasonably likely to occur (NRLTO) as a result of a prerequisite program, there is noncompliance with 9 CFR 417.2(a)(1) and 417.5(a)(1) because there is evidence that the prerequisite program may not effectively prevent the chemical hazard from being reasonably likely to occur (RLTO). IPP are also to verify that the establishment has implemented corrective actions that meet the requirements of 9 CFR 417.3(b) and 417.3(c) and, if it does not, IPP are to document noncompliance in a NR;
        3. If during the course of conducting the verification task, IPP find that a meat, poultry or egg product contains an undeclared allergen, and the establishment has identified that ingredient as a chemical hazard in its hazard analysis and has determined that it is RLTO, IPP are to document noncompliance in a NR citing 9 CFR 417.2(c)(4). IPP are to do so because they observed a deviation from the critical limit that was not identified through the establishment's monitoring procedure. IPP are also to verify that the establishment has implemented corrective actions that meet the requirements of 9 CFR 417.3(a) and 417.3(c) and are to document any noncompliance with these requirements in a NR.
    3. IPP are to consider what their verification findings show about the overall effectiveness of the establishment's food safety system and take these findings into account during the performance of the next Hazard Analysis Verification (HAV) task. Refer to FSIS Directive 5000.6, Performance of the Hazard Analysis Verification Task, for additional information regarding the performance of the HAV. IPP are to contact their FLS if they believe a directed HAV task is needed.
      1. Labeling: If during the course of conducting the verification task, IPP find that a meat, poultry, or egg product contains one of the "Big 9" allergens that is not declared on the final label, IPP are to document a food safety labeling noncompliance in an NR. The noncompliance is to be documented under the "Big 9" Formulation Verification task citing 9 CFR 317.2, 381.118, or 590.411(c)(1) as the relevant labeling regulations.
    4. If IPP detect other labeling issues, they are to describe and document their findings. For example, if IPP find that product contains an ingredient other than one of the "Big 9" allergens, and that the ingredient is not declared, or if the order of predominance of the ingredients on the label is incorrect, IPP are to schedule a directed General Labeling task and document a General Labeling noncompliance in an NR citing 9 CFR 317.2, 381.118, or 590.411(c)(1) as the relevant regulation. IPP are to discuss their concerns with their FLS if they believe misbranding has occurred. Inspectors should note that while the "Big 9" allergens are the most common allergenic foods, people may have adverse reactions to other substances as well. Consumption of some ingredients, such as sulfur-based preservatives (sulfites), lactose, FD&C Yellow 5 (Tartrazine), gluten, and monosodium glutamate (MSG), may result in an adverse reaction in certain susceptible individuals, yet they are not considered allergens.
  8. SUPERVISORY RESPONSIBILITIES
    1. Supervisors are to ensure that IPP have been trained and understand how to review labels and product formulations.
    2. The FLS may request or recommend a Public Health Risk Evaluation, Food Safety Assessment, or possible enforcement action if the establishment has not effectively ensured that allergens and ingredients are properly used and declared, or if the FLS determines that the lack of controls raises concerns about the adequacy of the meat, poultry, and egg products establishments' food safety system.
    3. The FLS is to contact the district office promptly if IPP findings indicate that a product with undeclared allergens may have entered commerce so that, if needed, a preliminary inquiry for a recall can be initiated following the instructions in FSIS Directive 8080.1.
  9. DATA ANALYSIS
    The Office of Planning, Analysis and Risk Management will analyze PHIS data from this verification activity. FSIS will use these analyses to determine whether additional policy instructions are needed.
  10. QUESTIONS
    Refer questions regarding this notice to your supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select Labeling as the Inquiry Type.

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

View full Attachments on Directive

  • Attachment 1 - Allergenic Ingredients and Foods
  • Attachment 2 - PHIS Questions for the "Big 9" Formulation Verification Task

 

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