In 2019, the Food and Drug Administration (FDA) and The United States Department of Agriculture (USDA) FSIS signed an agreement about the oversight of food made using cultured animal cells. The agreement explains the applicable laws and regulations related to cell-cultured meat under both FDA and USDA, specifically applicable HACCP regulations and the FDA Food Safety Modernization Act (FSMA) and the FDA New Era of Smarter Food Safety. Recently, UPSIDE Food Company and the Good Food Institute (GFI) cell-cultured chicken meat (Gallus gallus species) was recognized by FDA and USDA to be safe to enter the US commerce and is in compliance with all applicable laws and regulations. This HACCP course explains sciences, technologies, laws and regulations of manufacturing, processing, packing and holding of foods from cultured animal cells of livestock, poultry, seafood and all allowed animal species. The course covers meat, poultry, egg, and seafood HACCPs, FDA FSMA Seven Foundation Rules, the FDA New Area of Smarter Food Safety four core elements, labelling and packaging and other applicable laws and regulations of making food from cultured animal cells. The focus , however, is on identifying biological, chemical and physical hazards of food from cultured animal cells, determining risks and controlling hazards using the most current regulatory, scientific, and technical understanding of the safe manufacturing, processing, packing and holding of the food from cultured animal cells. In addition. the course covers procedures to follow under USDA and FDA to determine if any food from cultured animal cells can enter in U.S. commerce, both domestic and imported. Upon completion of the course, you will be able to write a HACCP plan for food from cultured animal cells from any animal allowed by FDA and USDA.
On Zoom – Instructor-Led
Other dates and times can be arranged.
2024
August 23, 2024, 8:00 AM to 4:00 PM – PST
August 24,, 2024, 8:00 AM to 4:00 PM – PST
October 25, 2024, 8:00 AM to 4:00 PM – EST
October 26,, 2024, 8:00 AM to 4:00 PM – EST
December 5, 2024, 8:00 AM to 4:00 PM – PST
December 6, 2024, 8:00 AM to 4:00 PM – PST
2025 Classes
April 28, 29, 2025 – EST
December 8, 9, 2025 – PST
Table of Contents
Module 1. Introduction, History of Food Safety Hazards and Controls and History of Cell Cultures
Module 2. The FDA and USDA Agreement about Food Made Using Cultured Animal Cells
Module 3. Cell Biology, Cell Differentiation, Stem Cells and Food Made from Cultured Animal Cells
Module 4. Bioreactors, Histology, Tissue Engineering, Developmental Biology and Food Made from Cultured Animal Cells
Module 5. The FDA Food Safety Modernization Act (FSMA) and Food Made from Cultured Animal Cells
Module 6. The FDA New Era of Smarter Food Safety, And Food Made from Cultured Animal Cells
Module 7. USDA FSIS Regulations of Meat, Poultry, Eggs, Fish and Human Food Made Using Cultured Animal Cells (Meat-Poultry and Siluriformes Fish)
Module 8. The FDA and USDA Packaging and Labelling Regulations and Food Made from Cultured Animal Cells
Module 9. Genomics, Metagenomics, Transcriptomics, Proteomics, Metabolomics, other Omics and Food Made from Cultured Animal Cells
Module 10. The FDA Inventory of Completed Pre-Market Consultations for Human Food Made with Cultured Animal Cells
Module 11. Biological Hazards and Controls for Foods Made from Cultured Animal Cells (Adventitious Agents)
Module 12. Chemical Food Safety Hazards and Hurdle and Emerging Technologies
Module 13. HACCP, Prerequisite Programs, and Food Made From Cultured Animal Cells
Module 14. Preliminary Steps: FDA Scientific Memorandum
Module 15. The First Principle of HACCP – Conduct a Hazard Analysis
Module 16. The Second Principle of HACCP – Determine Critical Control Points (CCPs)
Module 17. The Third Principle of HACCP – Determine Critical Limits
Module 18. The Fourth Principle of HACCP – Establish Monitoring Procedures
Module 19. The Fifth Principle of HACCP – Establish Corrective Action Procedures
Module 20. The Sixth Principle of HACCP – Establish Verification Procedures
Module 21. The Seventh Principle of HACCP – Establish Record-Keeping and Documentation Procedures
Module 22. Development, Implementation, Maintenance and Reassessments of HACCP Plan and Systems
Self-Paced – To be Completed within 60 Days
Table of Contents
Module 1. Introduction, History of Food Safety Hazards and Controls and History of Cell Cultures
Module 2. The FDA and USDA Agreement about Food Made Using Cultured Animal Cells
Module 3. Cell Biology, Cell Differentiation, Stem Cells and Food Made from Cultured Animal Cells
Module 4. Bioreactors, Histology, Tissue Engineering, Developmental Biology and Food Made from Cultured Animal Cells
Module 5. The FDA Food Safety Modernization Act (FSMA) and Food Made from Cultured Animal Cells
Module 6. The FDA New Era of Smarter Food Safety, And Food Made from Cultured Animal Cells
Module 7. USDA FSIS Regulations of Meat, Poultry, Eggs, Fish and Human Food Made Using Cultured Animal Cells (Meat-Poultry and Siluriformes Fish)
Module 8. The FDA and USDA Packaging and Labelling Regulations and Food Made from Cultured Animal Cells
Module 9. Genomics, Metagenomics, Transcriptomics, Proteomics, Metabolomics, other Omics and Food Made from Cultured Animal Cells
Module 10. The FDA Inventory of Completed Pre-Market Consultations for Human Food Made with Cultured Animal Cells
Module 11. Biological Hazards and Controls for Foods Made from Cultured Animal Cells (Adventitious Agents)
Module 12. Chemical Food Safety Hazards and Hurdle and Emerging Technologies
Module 13. HACCP, Prerequisite Programs, and Food Made From Cultured Animal Cells
Module 14. Preliminary Steps: FDA Scientific Memorandum
Module 15. The First Principle of HACCP – Conduct a Hazard Analysis
Module 16. The Second Principle of HACCP – Determine Critical Control Points (CCPs)
Module 17. The Third Principle of HACCP – Determine Critical Limits
Module 18. The Fourth Principle of HACCP – Establish Monitoring Procedures
Module 19. The Fifth Principle of HACCP – Establish Corrective Action Procedures
Module 20. The Sixth Principle of HACCP – Establish Verification Procedures
Module 21. The Seventh Principle of HACCP – Establish Record-Keeping and Documentation Procedures
Module 22. Development, Implementation, Maintenance and Reassessments of HACCP Plan and Systems
Onsite
Table of Contents
Module 1. Introduction, History of Food Safety Hazards and Controls and History of Cell Cultures
Module 2. The FDA and USDA Agreement about Food Made Using Cultured Animal Cells
Module 3. Cell Biology, Cell Differentiation, Stem Cells and Food Made from Cultured Animal Cells
Module 4. Bioreactors, Histology, Tissue Engineering, Developmental Biology and Food Made from Cultured Animal Cells
Module 5. The FDA Food Safety Modernization Act (FSMA) and Food Made from Cultured Animal Cells
Module 6. The FDA New Era of Smarter Food Safety, And Food Made from Cultured Animal Cells
Module 7. USDA FSIS Regulations of Meat, Poultry, Eggs, Fish and Human Food Made Using Cultured Animal Cells (Meat-Poultry and Siluriformes Fish)
Module 8. The FDA and USDA Packaging and Labelling Regulations and Food Made from Cultured Animal Cells
Module 9. Genomics, Metagenomics, Transcriptomics, Proteomics, Metabolomics, other Omics and Food Made from Cultured Animal Cells
Module 10. The FDA Inventory of Completed Pre-Market Consultations for Human Food Made with Cultured Animal Cells
Module 11. Biological Hazards and Controls for Foods Made from Cultured Animal Cells (Adventitious Agents)
Module 12. Chemical Food Safety Hazards and Hurdle and Emerging Technologies
Module 13. HACCP, Prerequisite Programs, and Food Made From Cultured Animal Cells
Module 14. Preliminary Steps: FDA Scientific Memorandum
Module 15. The First Principle of HACCP – Conduct a Hazard Analysis
Module 16. The Second Principle of HACCP – Determine Critical Control Points (CCPs)
Module 17. The Third Principle of HACCP – Determine Critical Limits
Module 18. The Fourth Principle of HACCP – Establish Monitoring Procedures
Module 19. The Fifth Principle of HACCP – Establish Corrective Action Procedures
Module 20. The Sixth Principle of HACCP – Establish Verification Procedures
Module 21. The Seventh Principle of HACCP – Establish Record-Keeping and Documentation Procedures
Module 22. Development, Implementation, Maintenance and Reassessments of HACCP Plan and Systems
There is a long history of scientific advances in biology, biochemistry, and engineering that have led to the innovations enabling the growth of animal cells outside of the animal itself, in a controlled environment, for food. The complex process can be broadly summarized in a few steps.
- Step 1: Manufacturers typically start with a sample of cells from the tissue of an animal, a process that does not require harm to or death of the animal. Some cells from the sample are selected, screened, and grown to make a “bank” of cells to store for later use.
- Step 2: A small number of cells are taken from the cell bank and placed in a tightly controlled and monitored environment (typically, a number of sealed sterile vessels of increasing size) that supports growth and cellular multiplication by supplying appropriate nutrients and other factors.
- Step 3: After the cells have multiplied many times over into billions or trillions of cells, additional substances (for example, protein growth factors, new surfaces for cell attachment, additional nutrients) are added to the controlled environment to enable the cells to differentiate into various cell types and assume characteristics of muscle, fat, or connective tissue cells.
- Step 4: Once the cells have differentiated into the desired type, the cellular material can be harvested from the controlled environment and prepared using conventional food processing and packaging methods. (By FDA)
