food safety modernization act a.k.a fsma - contract · pdf filefood safety modernization act...
TRANSCRIPT
![Page 1: Food Safety Modernization Act a.k.a FSMA - Contract · PDF fileFood Safety Modernization Act a.k.a FSMA September 25, 2012 Syed Hassan / Tom Tansey . Global Food Safety and Regulatory](https://reader036.vdocument.in/reader036/viewer/2022070606/5a87c4607f8b9a9f1b8dffb7/html5/thumbnails/1.jpg)
Food Safety Modernization Act a.k.a FSMA
September 25, 2012 Syed Hassan / Tom Tansey
Global Food Safety and Regulatory Affairs
Updated 9/7/12
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Awareness Session 2
Agenda • General Overview
– Why – Main Theme
• Main Elements of the Law • What is PepsiCo doing
– Organizationally – Compliance – Next steps
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3
The Public Health Imperative • Foodborne illness is a significant burden
– About 48 million (1 in 6 Americans) get sick each year – 128,000 are hospitalized – 3,000 die
• Immune-compromised individuals more susceptible – Infants and children, pregnant women, older
individuals, those on chemotherapy • Foodborne illness is not just a stomach ache—it can
cause life-long chronic disease – Arthritis, kidney failure
Awareness Session
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Awareness Session 4
Why is the law needed? • Globalization
– 15 percent of U.S. food supply is imported
• Food supply more high-tech and complex
– More foods in the marketplace
– New hazards in foods not previously seen
• Shifting demographics
– Growing population (about 30%) of individuals are especially ―at risk‖ for foodborne illness
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Awareness Session 5
What’s so historic about the law?
• Involves creation of a new food safety system
• Broad prevention mandate and accountability
• New system of import oversight • Emphasizes partnerships • Emphasizes farm-to-table responsibility • Developed through broad coalition
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Awareness Session 6
Main Themes of the Legislation
Prevention
Inspections, Compliance, and Response
Import Safety
Enhanced Partnerships
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Awareness Session 8
Main Elements of New Law
1. New Responsibilities on Food Companies
2. New Controls over Imported Food 3. Enhanced Enforcement Powers 4. New Fees on Food Companies and
Importers
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Awareness Session 9
1. New Responsibilities for Food Companies
• Impacting daily operations in all registered facilities, domestic and foreign – Food Safety Plans/Preventive Controls
(Hazard analysis)
– Supply Chain Management – Records Maintenance and Access – Food Defense Plans – Section 103 of bill; section 418 of FDC Act and Section
106 of bill; section 420 of FDC Act
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Awareness Session 17
3. Enhanced Enforcement Powers • More Frequent FDA Inspections
– Section 201 of bill; section 421 of FDC Act
• Mandatory Recall Authority – Section 206; section 423
• Suspension of Facility Registration – Section 102; amending section 415(a)
• Administrative Detention – Section 207; amending section 304(h)
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Awareness Session 19
4. New Fees on Food Companies and Importers
• Reimbursement to FDA – Re-inspections – Recall (limited)
• Section 107 of bill; section 743 of FDC Act
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Awareness Session 20
So, What Are We Doing
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Awareness Session 21
PepsiCo FSMA Taskforce (Leadership) Leadership Team
PEP
GFSRA
Global Security
PCNA
GFSRA
Legal GFSRA
PBC
SSM
FLNA
PEP
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Awareness Session 22
Leadership -- Ways of Working
• Leadership Team holds monthly meetings. – Review status of FDA guidance documents – Set FSMA strategy within PepsiCo – Identify opportunities based on FSMA
requirements – Communicate within the organization – Implementation and verification planning – Provide guidance and mentorship
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Awareness Session 23
Next Steps – For Your Organization
• Awareness Sessions. • Engagement with FSMA. • In-depth training for key associates. • Gap assessment. • Gap closure activities. • Monitor compliance.
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Awareness Session 24
While we are waiting for the Guidance Documents…..
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We are Working on…
• Updating food safety plans HACCP • Supplier verification activities • Food defense plans • Updating record keeping requirements • Facility re-registrations • FDA Inspections guidance • Foreign suppliers/ imports
Awareness Session 25
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Comparison
26
ELEMENT FSMA FSSC 22000
SQF BRC
Scope ☺ ☺ ☺ References ☺ ☺ ☺ Definitions ☺ ☺ ☺ Document Management ☺ ☺ ☺ ☺ Records Management / Retention ☺ ☺ ☺ ☺ Management Review ☺ ☺ ☺ Food Safety Plan/Policy ☺ ☺ ☺ ☺ Communication ☺ ☺ ☺ ☺ Management Review ☺ ☺ ☺ ☺ Training ☺ ☺ ☺ ☺ Infrastructure ☺ ☺ ☺ ☺ Emergency Preparedness/ Continuity ☺ ☺ ☺ ☺
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Comparison
27
ELEMENT FSMA FSSC 22000 SQF BRC
Food Safety Plan / HACCP ☺ ☺ ☺ ☺ Verification ☺ ☺ ☺ ☺ Control of Nonconforming ☺ ☺ ☺ ☺ Corrections & Corrective Action ☺ ☺ ☺ ☺ Control of Measuring & Monitoring ☺ ☺ ☺ ☺ Validation ☺ ☺ ☺ ☺ Consumer Complaints / Mitigation ☺ ☺ ☺ ☺ Internal Audits ☺ ☺ ☺ ☺ Continuous Improvement ☺ ☺ ☺ ☺ Food Safety Management System ☺ ☺ ☺ ☺ Traceability ☺ ☺ ☺ ☺
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Comparison
28
FSMA FSSC 22000 SQF BRC Construction & Layout of Buildings ☺ ☺ ☺ ☺ Utilities: Air, Water, Energy ☺ ☺ ☺ ☺ Layout of Premises and Workspace ☺ ☺ ☺ ☺ Waste Disposal ☺ ☺ ☺ ☺ Equipment Suitability ☺ ☺ ☺ ☺ Management of Purchased Materials ☺ ☺ ☺ ☺ Cleaning & Sanitizing ☺ ☺ ☺ ☺ Pest Control ☺ ☺ ☺ ☺ Personnel Hygiene (GMPs) ☺ ☺ ☺ ☺ Rework / Repackaging ☺ ☺ ☺ ☺ Product Recall Program ☺ ☺ ☺ ☺ Warehousing ☺ ☺ ☺ ☺
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Comparison
29
FSMA FSSC 22000 SQF BRC Product Information / Consumer Awareness
☺ ☺ ☺ ☺
Food Defense ☺ ☺ ☺ ☺ Cross Contamination ☺ ☺ ☺ ☺ Specification & Product Development ☺ ☺ ☺ Stock Rotation ☺ ☺ ☺ ☺ Chemical Control ☺ ☺ ☺ Safe & Legal Product ☺ ☺ ☺ ☺ Food Safety Team Leader / HACCP ☺ ☺ ☺ Metal Control ☺ ☺ ☺ ☺ Glass, Brittle Plastic & Ceramic Control ☺ ☺ ☺ Allergens ☺ ☺ ☺ ☺ Medical Screenings ☺ ☺ ☺ ☺
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Awareness Session 30
Thank you