The document discusses the Food Safety Modernization Act (FSMA), which establishes new rules for food safety in the United States. It was signed into law in 2011 to better protect public health by strengthening the food safety system from farm to table. The FSMA impacts farmers, food manufacturers, transporters, importers and others. Its major components establish requirements for preventive controls, inspections and compliance, imported food safety, and enhanced partnerships between food safety agencies. Compliance dates vary depending on business size, with larger businesses required to comply sooner.

1. www.yournextep.com
FDA Food Safety Modernization Act (FSMA)
Are You Ready to Implement It?
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2. Nikoo Arasteh, PhD, MBA
SPEAKER
Nikoo Arasteh, PhD, MBA
• Consultant to Food and Bio-Pharma industries
• Focused on Food Safety and Regulatory Compliance
• Ideation for new value-added food products
• PhD in Food Science
• Master’s Degree: Food Microbiology
• MBA: Industrial Management
• 20+ Years in Food and Biotech/Pharmaceutical Industries
• University Professor & Academic Researcher
• Author of scientific papers & text book
• Project Manager, Quality Manager, R&D Manager
• HACCP & GMP Certified
• Business owner YourNextep Consulting
• Collaborating consultant with Manex Consulting, Inc
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3. Nikoo Arasteh, PhD, MBA
OVERVIEW
Why new rules needed
 What is Food Safety Modernization Act (FSMA) ?
Who is impacted?
FSMA major components
Timelines
Q & A
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4. Nikoo Arasteh, PhD, MBA
WHY NEW RULES?
 Every year, from foodborne illnesses
• 48 million (1 in 6) Americans get sick
• 128,000 are hospitalized,
• 3,000 die
 Food supply system has become more complex
• 15% of the US food is imported
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5. Nikoo Arasteh, PhD, MBA
WHAT IS FSMA?
 FSMA is the new FDA rules for food safety
 Signed into law Jan. 4, 2011
 Protect public health by strengthening food safety system
 Science-based standards for food safety from farm to table
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6. Nikoo Arasteh, PhD, MBA
WHO IS IMPACTED?
Farmers
Food Manufacturers and processors
Transporters
Importers
Laboratories
Third-party auditing organizations
Foreign food processors
Foreign governments
Warehouses, storage tanks and grain elevators
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7. Nikoo Arasteh, PhD, MBA
FSMA MAJOR COMPONENTS
FSMA
Prevention
Inspection
Compliance
Response
Import
Safety
Enhanced
Partnership
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8. Nikoo Arasteh, PhD, MBA
FSMA MAJOR COMPONENTS
1. Preventive Controls
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Graphics borrowed from Packaging World

9. Nikoo Arasteh, PhD, MBA
FSMA MAJOR COMPONENTS
1. Preventive Controls: Examples
 Sanitation procedures and practices
 Training for supervisors and employees
 Environmental monitoring
 GMPs
 Food allergen controls
 Recall contingency plan
 Supplier verification program
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10. Nikoo Arasteh, PhD, MBA
FSMA MAJOR COMPONENTS
2. Inspection and Compliance
 Risk-based inspection prioritization
• Hi-risk facilities:
Once during first 5 years after enactment
Every 3 years thereafter
• Other facilities
Once during first 7 years after enactment
Every 5 years thereafter
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11. Nikoo Arasteh, PhD, MBA
FSMA MAJOR COMPONENTS
2. Inspection and Compliance
 Food facility registration, renewal every 2 years
 FDA mandatory recall authority
If suspected of adulteration or misbranding
 FDA can suspend registration
 Fees for re-inspection and recall follow up
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12. Nikoo Arasteh, PhD, MBA
FSMA MAJOR COMPONENTS
3. Imported Food Safety
 Importers: implement foreign supplier verification plan
 FDA can reject imported food if not allowed to inspect
 FDA can require compliance certificate for imported foods
 Importers: food safety program to receive expedited
review of shipments
2011
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13. Nikoo Arasteh, PhD, MBA
FSMA MAJOR COMPONENTS
3. Imported Food Safety
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Graphics adapted from FDA presentation

14. Nikoo Arasteh, PhD, MBA
FSMA MAJOR COMPONENTS
4. Enhanced Partnership
 Collaboration of federal, state, local, and foreign food
safety agencies
 Certified testing labs
 Certification for the 3rd party auditors
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15. Nikoo Arasteh, PhD, MBA
TIMELINES
Compliance Dates by Business Size
(Adopted from www.fda.gov/fsma)
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16. Nikoo Arasteh, PhD, MBA
TIMELINES
Compliance Dates by Business Size
(Adopted from www.fda.gov/fsma)
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17. Nikoo Arasteh, PhD, MBA
Q & A
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