food safety in focus – the us...
TRANSCRIPT
Food Safety in Focus – The US Experience
• Food Safety Definitive Controls – The “kill-step”
• Why pasteurize?
• The Almond Board of California (ABC) Experience with Salmonella
– History of our Program
• Our approach
– Process & By the numbers
• Where do we go from here?
So, Why do we do what we do?
• We want to avoid being a head-line
So, Why do we do what we do?
• We want to avoid being a head-line
• We don’t want to make anyone sick
• We want consumers to understand that our product is safe
• And......we know that low level contamination with Salmonella is present, and cannot be controlled completely through GAP’s alone
Year #Positive #TotalPrevalence
Rate(%Positive)
2001 12 2003 0.6
2002 24 2012 1.2
2003 15 1764 0.8
2004 12 1643 0.7
2005 18 1852 1.0
2006 30 1899 1.6
2007 15 1799 0.8
2010 10 1000 1.0
2013 22 2037 1.1
Total 158 16009 1.0
ABC Almond Salmonella Survey Data (100g Samples)
Salmonella Concentration on almonds (MPN/100 g)
Rel
ativ
e fre
quen
cy
0 5 10 15 20
0.0
0.5
1.0
1.5
2.0
Levels less than 3 to 15.5 MPN/g
Our survey work shows us that Salmonella is a real risk
So, we pasteurize because….
It really is the only definitive way we can control the risk and ensure the consumer is receiving a safe product.
California Almonds and Salmonella – Not so pleased to make your acquaintance!
• 2001 – Canadian health authorities initiate an alert and subsequent recall due to Salmonellosis outbreak associated with raw almond consumption
– Over 134 cases in Canada and 71 in US
– First time an outbreak had ever been associated with almond consumption
• 2004 – Outbreak due to Salmonellosis associated with raw almond consumption identified by Oregon health officials
– Outbreak linked in eight other States in the United States
– >30 Cases
Pasteurization Approved by ABC Board of Directors• Voluntary program approved June, 2004
• Mandatory program approved August, 2006 with September 1, 2007 effective date
ABC Pasteurization Program –3 Keys to Credibility
• Research
– Microbial Surveys – 16,000 + samples over 9 years
– Pathogen / Surrogate Studies
– Risk Assessment
– Validation research
• Protocols for testing
• Guidance Documents
• Independent Validation & Review
– ABC approved Process Authorities
– Technical Expert Review Panel (TERP)
• Audits
– USDA audits of Handlers and Custom Processors
– ABC reviewed audits of DV Users
7 CFR Part 981.442 Mandatory Pasteurization Program
• Requires all product shipped within North America be subjected to a process that delivers a minimum 4-log reduction of Salmonella bacteria on almonds
– Can utilize Custom Processors
– Can ship to Direct Verifiable Users
– Export shipments not subject to pasteurization requirement (other than Canada and Mexico)
Validation by Board Approved Process Authority
• All processes must be validated by Board approved Process Authority
– Experts in almond processes
– Experience in conducting microbiological challenge testing and thermal temperature mapping studies
– 17 Board approved Process Authorities
ABC Technical Expert Review Panel (TERP) –Established 2004
• ABC TERP
– Experts in microbiology, process engineering, pasteurization, validation and regulatory requirements
– Conduct technical reviews of equipment and validation reports to determine ability to deliver a minimum 4-log reduction
– Assist in development of technical guidelines and protocols
Validation Guidelines Developed
• Enterococcus faecium NRRL B-2354
• Blanching
• Oil Roasting
• Dry Roasting
• Steam/Moist Air
• PPO
Validation Studies / Protocols – Oil Roasting
• Minimum Critical Factors• Time: Minimum 2 minutes
• Critical factor will be speed setting
• Temperature: 260°F
• Temperature must remain at or above 260°F throughout roaster
Oil Roasting Validation
• Validation Objective
• To verify almonds are exposed to oil temperatures exceeding 260°F for a minimum time of 2 minutes
• Validation Methodology
• Temperature mapping and/or temp profile during production
• Residence time confirmation
• Product loading (Throughput)
• Verification of Controls
• Typical Critical Factors
• Belt/Chain Speed
• Belt Depth
• Temperature
• Common Issues
• Cold Spots or lack of cold spot identification
• Process recordation
• Poor cooling air filtration
• Fixed bed depth
Steam & Other Processes Validation• Validation Objective
• Identify controllable operating conditions which will consistently deliver a minimum 4-log destruction of SE PT 30
• Validation Methodology
• Temperature mapping and/or temp profile to determine heat distribution
• ID worst case scenario product (ie. Low moisture)
• Conduct micro challenge testing (with multiple runs with multiple samples/run)
• Ensure set points are adjusted to test under conditions which can be exceeded during normal production (Temp, Cooling air, belt speed, etc)
• Residence time confirmation
• Product loading (Throughput)
• Verification of Controls
• Possible Critical Factors
• Belt Speed (Time)
• Air temperature
• Air flow / Direction
• Steam flow / volume
• Product loading
• Initial product temperature
• Burner Temperatures
• Cooling flow and temperature
• Nut Moisture
• Product size
• Vacuum
•
The ABC Validation Process
Company or Vendor Consultation with ABC and PA on equipment
PA validation studies
ABC staff (and TERP) support & review
TERP review & determination
Goal is to demonstrate ability to achieve a minimum
4-log reduction of Salmonella bacteria on
almonds
ABC Pasteurization Providers
• Handlers
– Must ensure all shipments within US, Canada and Mexico are treated >4-log process
• Can be there own process, or utilize Custom Processor
• Custom Processors
– Provide pasteurization on a toll basis
• Direct Verifiable Users
– Manufacturers (Non-Handlers) who have gone through ABC validation process
Technologies Currently in Use or in Validation Process
• H20 Express – Vacuum steam
• JSP-1 (Formerly FMC) Moist Steam
• Revetech – Steam/Hot Air
• Napasol – Vacuum Steam
• Buhler/Barth – Moist Heat
• RF Biocidics – Radio Frequency/Heat
• Ventilex – Atmospheric Steam
• PPO
Active Validations (As of 10/21/14)
Equipment Type # Validations*
Blancher 31
Oil Roaster 87
PPO Chamber 23
Dry Roaster 28
Steam Plasticizer 5
Pasteurizer (Steam ambient/vacuum) 9
Pasteurizer (Moist heat/other) 9
Total of 177 units at 70 Locations
*Each unit may be have more than 1 validation in place. i.e. Process for inshell, process for kernels, 4-log, 5-log, etc.
Compliance – Key for Credibility
• All Handlers
– Submit an annual Handler Treatment Plan describing how product is handled in accordance with pasteurization program
• At least once per year
• Handlers with Processes & Custom Processors (Toll Pasteurizers)
– At least twice per year
• Direct Verifiable Users
– At least once per year
All Almond Handlers – HTP Plans
The plan shall describe how a handler plans to treat his or her almonds and must address post process contamination control.
1 verification per month until no-non conformities are identified.
1 verification per quarter
until a “passing verification.”
1 verification per year until a
“failed
verfication.”
Handler & Custom Processor Audits
Monthly
• Monthly audits are conducted for the first 3 months to verify operation within defined critical parameters.
• Equipment is observed in operation
• Records are reviewed
Quarterly
• After three months of sucessful audits, the processor is moved to a quarterly audit schedule. • If a major non-conformity is identified, the processor is placed back on a monthly schedule.
• After a successful first quarterly audit, the processor is moved to a bi-annual schedule
Bi-Annually
• Audits are conducted bi-annually as long as no major non-conformities are found. • Major non-conformities will result in being placed back on a monthly schedule.
• Major non-conformities must be addressed in writing to the Board, and may result in removal from the program
Direct Verifiable (DV) Users (Non-Handler Manufacturers)
• DV Users audited by ABC approved auditor within 1-2 months after validation acceptance by TERP to verify:
– Appropriate process is used (Critical Factors)
– Post process contamination controls are in place
– Records are maintained
Post Process Contamination Control – The Final Piece
• Factors to consider
– Plant Layout
– Air Handling Systems
– Sanitation
– Pathogen Environmental Monitoring
Moving Forward
• Align industry practices with Federal Regulations (FSMA)
• Stimulate development of new pasteurization technologies
• Continue to evolve food safety programs
Thank-you!