american shrimp processors association
TRANSCRIPT
American Shrimp Processors Association
Annual meeting
April 6-7, 2017
Beau RivageBiloxi, Mississippi
W. Lynn Hodges, Associate Consultant
HACCP Consulting Group, L.L.C.
Oklahoma Department of Health
Tulsa City-County Health Department
U.S. Food and Drug Administration
USDA/Food Safety Inspection Service
U.S. Food and Drug Administration
HACCP Consulting Group, L.L.C.
Where I spent my Food Safety Career
HACCP Consulting Group, L.L.C.
• Started in 1995• 10 food safety professionals• Domestic and international work
• International – work in over 50 foreign countries
• Food Safety work – Meat, Poultry, Eggs (USDA)
• Processed foods, produce, seafood, etc. (FDA)
• Retail Food (HACCP, ROP, Cook-chill, Sous vide)
HACCP Consulting Group, L.L.C.
• HACCP consultation and Plans, etc.• FDA Regulatory Compliance• FSIS Regulatory Compliance• SQFI• International Services• Training programs• Program review/development• Trade Associations, Law• Labeling• Food Defense• GFSI• SafetyChain Software
Seafood HACCP and ……..FDA’s Preventive Controls for Human Foods
FDA Seafood Program Report – Dec 2000
• ‘FDA's seafood program was the first national regulatory program to operate on the basis of HACCP principles. The impetus for mandating a HACCP regulatory program for seafood processors began in the late 1980's. While there was no public health crisis associated with seafood -- a National Academy of Sciences report in 1991 stated that most seafood is unlikely to cause illness to the consumer --but there was an erosion of confidence in seafood safety, caused by a number of factors.’
Seafood HACCP rules - 1997
• Seafood HACCP rules – (21 CFR 123) -- December 1997
• 3600 U.S. seafood processors – over 350 species of fish
• Requires a HACCP system
• Hazard Analysis Critical Control Point (HACCP)• ‘a science-based system of preventive controls for food safety’
• PURPOSE: 1) increase margin of safety 2) reduce illnesses to the lowest possible levels
HACCP
Hazard Analysis and Critical Control Points (HACCP) is a process control
system designed to identify and prevent microbial and other hazards in food
production.
HACCP Systems (the Basics)
• 7 Principles of HACCP• Conduct hazard analysis• Identify CCP (Critical Control Points)• Establish critical limits for CCP• Establish CCP monitoring requirements• Establish corrective actions• Establish record keeping procedures• Establish verification procedures
Eight Categories of Food Safety Hazards in Seafood
• HAZARDS• Pathogens
• Parasites
• Ciguatera
• Histamine
• Environmental chemicals
• Aquaculture drugs
• Unapproved food additives
• Physical hazards
Regulatory seafood HACCP is a tool –FD&C Act
• Primary provision is section 402(a)(4)• Food is adulterated if it is prepared, packed or held
under conditions whereby it may have been rendered injurious to health.
• Also, conditions are objectionable if they do not sufficiently protect against contamination by potentially unsafe substances in amounts that cause the food to be adulterated…….
HACCP Systems, Technical Issues, and Science
• NACMCF• National Advisory Committee on Microbiological
Criteria for Foods• A National Advisory Committee on Microbiological Criteria for
Foods (NACMCF) provides impartial, scientific advice to federal food safety agencies. ...
• Composition –• Regulators, Scientists, Academia
Preventive Controls for Human Food – 21 CFR part 117
“Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food”
FDA issued proposed rule Jan 16, 2013
Final Rule: September 17, 2015Compliance Date: depends on business size
FSMA - Key Principles• Industry has primary role on food safety
• Prevention of hazards (microbiological, physical, chemical – radioactive)
• Risk-based
Rules of FSMA
• Rules for Produce (Growing, harvesting, Packing, Holding) 2015
• Preventive Controls for Human Foods 2015
• Preventive Controls for Animal Foods 2015
• Sanitary Transportation of Human and Animal Food 2016
• Accredited Third Party Certification (Auditors) 2015
• FSVP for Importers of Foods (Human and Animals) 2015
• Mitigation Strategies/ Protect Food Against Intentional Adulteration (2017)
Prevention Control Requirements
• Hazard Analysis and Risk-Based Preventive Controls• - Each facility is required to implement a written food safety plan
that focuses on preventing hazards in foods
• Updated Good Manufacturing Practices• 21 CFR Part 117 (new)
FSMA Key Requirements –Facilities must establish/implement a written food safety system that includes analysis of hazards and risk-based preventive controls
• Hazard analysis
• Preventive Controls• Monitoring
• Corrective actions and corrections
• Verification
Who is Covered by FSMA?
• Facilities that manufacture, process, pack or hold human food
• In general, facilities required to register with FDA under sec. 415 of the FD&C Act
• Applies to domestic and imported food
• Some exceptions and modified requirements
FSMA Applies to:
• Any food facility in the United States or abroad that produces food products for distribution in the United States
• Also, subject to registration under the Bioterrorism and Response Act of 2002.
FSMA Preventive Controls do not apply to:
• USDA – Meat, poultry, egg processing facilities
• Produce processors, etc.
• Facilities that comply with FDA’s seafood and juice HACCP regulations
• Low Acid and acidified canned food processors (microbiological)
• Some ‘small’ or ‘very small’ businesses
• Companies with a 3 year average product value of less than $500,000 annually
Hazard Analysis and Risk-Based Preventive Controls
Preventive Controls Required
• Process Controls
• Food Allergen Controls
• Sanitation Controls
• Recall Plan
• Supplier approval and verification program
Verification Activities Required
• Validation
• Calibration
• Review of records
• Environmental testing/Product Testing
Do these look similar to HACCP?
FDA seafood HACCP program applies to foreign seafood products exported to the U.S.
• Conducts specially targeted inspections overseas• Usually directed toward nations that are unlikely to be
operating advanced HACCP systems• Imposes responsibilities on importers of foreign seafood
products• Example: Evidence that foreign suppliers are meeting U.S.
requirements• Importer inspections – meeting ‘affirmative steps’ • Inspections are stored in FDA data system
Training for HACCP and FSMA Preventive Controls
Are they the same?• National Seafood HACCP Alliance
• International HACCP Alliance
• Food Safety Preventive Controls Alliance• Preventive Controls for Human Foods
• Preventive Controls for Animal Foods
• Sprout Safety Alliance
Typical HACCP Training Agenda• Principles of HACCP
• Conducting the Hazard Analysis
- identifying the hazards (micro, chemical, physical)
• Defining the CCP (Critical Control Points)
• Establishing the Critical Limits
• Monitoring
• Corrective Actions
• Recordkeeping
• Verification
Typical FSMA Preventive Controls Training Agenda
Food Safety Plan OverviewGood Manufacturing Practices / Other PRPBiological, Chemical, Physical HazardsEconomically Motivated HazardsSteps in a Food Safety PlanHazard Analysis and Preventive Controls DeterminationProcess Preventive ControlsFood Allergen Preventive ControlsSanitation Preventive ControlsSupply Chain Preventive ControlsVerification and Validation ProceduresRecall Plans
Questions ---- Comments
www.haccpcg.com
Main office:
4916 Waple LaneAlexandria, Virginia 22304Tele: 757-371-5832
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