preparing for the food safety modernization act. agenda 1.introduction to the food safety...

Preparing for the Food Safety Modernization Act

Agenda1. Introduction to the Food Safety

Modernization Act (FSMA)

2. Common Non-Conformances a) PrimusGFSb) SQFc) Global GAP

3. Improvement Strategies

I Promise This Will Be Fun!

HACCPFSMAGFSI

Food Safety Modernization Act

http://www.fda.gov/Food/GuidanceRegulation/FSMA/

Key Themes and Concepts

Common Acronyms

FSMA Food Safety Modernization Act

HACCP Hazard Analysis and Critical Control Points

HARPC Hazard Analysis and Risk Based Preventative Controls

FSVP Foreign Supplier Verification Program

PHF Potentially Hazardous Food

RTE Ready to Eat

RLTO Relatively Likely to Occur

QAR Qualitative Assessment of Risk

VQIP Voluntary Qualified Importer Program

SAHCODHA Serious Adverse Health Consequences or Death of Humans or Animals

Prevention

• Mandatory Preventive Controls for Food Facilities

• Mandatory Produce Safety Standards

• Intentional Adulteration Standards

• Foreign Supplier Verification/Transport safety

FSMA Implementation Dates

Who is Affected by FSMA?

• Manufacturers and processors• Farmers and growers• Transporters• Retailers• Importers• Laboratories• Third party certification bodies• Foreign governments

Who is Exempt from this Rule?• Juice and Seafood HACCP programs• Low acid canned foods• Alcoholic beverage processing• Dietary supplement manufacture,

processing or holding• Storing raw agricultural products other

than fruits and vegetables (Grain)• Storing unexposed packaged food at

ambient temperatures

Qualified Individual

• Prepares and Manages the Food Safety Plan

• Validates Preventive Controls

• Reviews Records• Determines Appropriate

Corrective Actions • Reviews Food Safety Plan

FSMA Preventive Controls

Hazard Analysis

Preventive Controls

Monitoring

Corrective Actions

Verification

Reanalysis

Documentation

HARPC for FacilitiesFSMA Section 103 Hazard Analysis and Risk-Based PreventiveControls (HARPC)• Evaluate Food Safety Hazards • Identify and Implement Preventive

Controls• Monitor Controls• Maintain Monitoring Records• Conduct Verification Activities

HACCP vs HARPC

What is the difference between HACCP and HARPC?

HACCP Plan

Prerequisite Programs/ GMPs

HACCP Plan

Prerequisite Programs/ GMPs

Elevated Prerequisite Programs

HACCP + Elevated PRPs=

HARPC Plan

Produce RuleSec. 105. Standards for Produce Safety

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• Agricultural Water• Soil Amendments • Health and Hygiene • Hazards in the growing area

(Animals) • Equipment, Tools and Facilities• Sprout Production Enhancements

Sanitary Transport

Sec. 111. Sanitary Transportation of Food• Sanitary transportation practices• Documentation

Import Safety Importer accountability Third Party Certification Certification for High Risk Foods Voluntary Qualified Importer Program (VQIP)Authority to Deny Entry

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Steps to FSMA Compliance

Inspection and Compliance• Mandated inspection

frequency (At least every 3 years if high risk)

• Records Access• Potential Testing of

Products

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Regulatory Response• Mandatory Recall• Expanded Administrative

Detention• Suspension of Registration• Record Retention

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Foreign Supplier Verification Program

• Importers will be required to develop, maintain and follow FSVP for each food imported

• Requirements vary based on• Type of food product• Category of importer (small, very small)• Nature of the hazard identified in food• Who controls the hazard

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FSVP Requirements: Activities• Compliance Review of Foods and Suppliers• Hazard Analysis (Biological, Chemical and Physical)

• Supplier Verification Activities• Corrective Actions (if needed)• Periodic Reassessment of the FSVP• Importer Identification at Entry• Recordkeeping

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Third Party Certification Programs

Tool for importers to obtain needed assurances under FSVP Participate in the VQIP to expedite movement of food Can be required by FDA to accompany high-risk foods

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Enhanced Partnerships

Inspection by Other Agencies International Capacity Building Improved Foodborne Illness Surveillance

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So what are our collective challenges?

PrimusGFS Documentation NCs

Source: Azzule PrimusGFS v2.1

PrimusGFS Documentation NCs

PrimusGFS Facility NCs

PrimusGFS Facility NCs

SQF Document

Source: SQFI

Certification Re-Certification Surveillance

Interesting to note which NCs occur in every certification scenario:2.5.7.1 – Internal Audits

Specifically a routine internal inspection program shall be implemented and documented

2.4.5.4 – Incoming goods and services Specifically approval should be based on performance

SQF Facility

Source: SQFI

Certification Re-Certification 6 Mo Surveillance

Which NCs occur in every cert scenario?•11.2.13 – Cleaning and Sanitation (*This clause has 8 subparts)•11.7.5 – Control of Foreign Material•11.2.3 – Walls, Partitions, doors, and Ceilings•11.2.12 – Equipment, Utensils, and Protective Clothing

SQF Quarterly Report

Source: SQFI

Minor Major Critical

GlobalGAP IFA v4.0

Food Safety Related

How to improve your GFSI performance?

How to improve your GFSI performance?How do you measure the success of your Program? Key Performance Indicators (KPIs)• Internal Audit Findings• 3rd Party Audit Score• Customer Complaints• Sanitation Performance• Maintenance Program Review• Training Program Performance

How to improve your GFSI performance?Do you have a strong TEAM? Do you have the right hierarchy?Are the right people in the right positions? • Proper balance of personality types

Do employees communicate well? Do you have a commitment to excellence that is humane?

•How is your employee turnover in key positions?

How to improve your GFSI performance? Focus on Fundamentals This is Food you produce Keep your process simple and try not to do too much Use data to guide your decisions

Thank You

Greg KomarNSF Agriculturegkomar@nsf.orgwww.nsf.org