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

Awareness Session 2

Agenda • General Overview

– Why – Main Theme

• Main Elements of the Law • What is PepsiCo doing

– Organizationally – Compliance – Next steps

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

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

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

Awareness Session 6

Main Themes of the Legislation

Prevention

Inspections, Compliance, and Response

Import Safety

Enhanced Partnerships

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

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

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)

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

Awareness Session 20

So, What Are We Doing

Awareness Session 21

PepsiCo FSMA Taskforce (Leadership) Leadership Team

PEP

GFSRA

Global Security

PCNA

GFSRA

Legal GFSRA

PBC

SSM

FLNA

PEP

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

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.

Awareness Session 24

While we are waiting for the Guidance Documents…..

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

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 ☺ ☺ ☺ ☺

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 ☺ ☺ ☺ ☺

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 ☺ ☺ ☺ ☺

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 ☺ ☺ ☺ ☺

Awareness Session 30

Thank you