Embed Size (px)
Citation preview
Caroline Smith DeWaal Director of Food Safety
Center for Science in the Public Interest
Implementing the Food Safety Modernization Act
Food Policy Impact Conference
Dec. 6, 2012
CSPI is a bi-national consumer advocacy organization founded in 1971 by Michael Jacobson, Ph.D.
Focuses on nutrition, health, and food safety.
Publishes the award-winning Nutrition Action Healthletter.
Accepts no government or industry funding.
Implement preventive food safety system, with standards on farms and for processors
Effective implementation of the Bioterrorism Act Programs ◦ Registration ◦ Records access ◦ Traceability
Address weaknesses in imported food oversight
Improve foodborne Illness surveillance system
Source: University of Minnesota Food Industry Center; Louisiana State University AgCenter
Kyle Allgood (2003-2006)
Lauren Bush
48 million illnesses, 128,000 hospitalizations and 3,000 deaths annually, CDC.
Shirley Mae Almer
Biennial registration
Preventive controls
Performance standards
Produce safety standards
Mandated inspection schedules for domestic
and foreign facilities.
Importer accountability and certification for
high-risk foods
President Obama signs FSMA Jan. 4, 2011
Records access
Administrative detention
Mandatory recall
Enhanced consumer notice on website
Biennial registration/suspension
Improved prior notice for imported food
Preventive controls for food and feed
Produce safety standards
Foreign Supplier Verification Program
Third-party accreditation
Certification of high-risk foods
High-risk traceability
Enhanced foodborne illness surveillance
2011 2012 2013 2014 2015
Small Very Small
2nd Re-registration 1st Re-registration
Registration
Prevention
Inspection
High Risk
Non-High Risk
On-Farm
(Produce)
Traceability
Pilot Projects
High Risk Records
Proposed Rule Final Rule
7 years
All facilities inspected
18 months
2 years
2011 2012 2013 2014 2015
600 1,200 2,400 4,800 9,600
Small Very Small
Inspection
Prevention
FSVP
VQIP
Capacity Bldg
Certification Authority Accreditation 3rd Party Auditors
Food Safety Modernization Act: Industry
Implementation
IFT Food Policy Impact
December 6, 2012
Leon H. Bruner, DVM, PhD
Senior Vice President, Science and Regulatory Affairs
Today’s Discussion
• Brief introduction to GMA
• GMA Support for Passage of FSMA
• GMA Support in Pre-Rulemaking Process
• Preparing the Industry for FSMA
• Questions and Answers
2
www.gmaonline.org
The Grocery Manufacturers Association
• Represent the world’s leading food, beverage and
consumer product companies
• Provide leadership in food safety based on
scientific excellence
• Promote science-based public policy and
champions initiatives for productivity and growth
www.gmaonline.org *Represents a sample of GMA members
GMA Members
General Members
Associate Members
GMA Member’s Goal
Deliver safe, quality products that customers trust and want to serve their families
We work with all interested parties to foster
implementation of effective transparent safety systems that ensure production of safe foods that
consumers trust
FSMA came from the Four Pillars
Developed by GMA in 2007
Mandatory Foreign Supplier Quality
Assurance Program
Voluntary Qualified Importer
Food Safety Program
Capability Building
Foreign Focus
Capability Building US
Border Focus
www.gmaonline.org
A broad consortium of
stakeholders
supported FSMA
The Legislative Process
Food Safety Modernization Act
Signed January 4, 2011
Main Elements of New Law
New Responsibilities for Producers
• Food safety plans with hazard analysis and
preventative controls
• Supply Chain Management
• Records Maintenance and Access
• Food Defense Plans
New Controls on Imported Food
• Foreign Supplier Verification
• Voluntary Qualified Importer Program
• Import certification
• Foreign capacity building
Enhanced Enforcement Powers for FDA
New Fees on Companies and Importers 7
www.gmaonline.org
Who and what will FSMA affect?
Size of the Food Industry
• Processed food sales
approximately $3.2 trillion
• 16.5 million employees
• >100,000 food producing
facilities in US alone
• Many, many more foreign
facilities
Range of Foods Impacted
• Fresh Produce
• Frozen Foods
• Processed Foods
• Dry Goods
• Confectionaries
• Infant Foods
• Spices
• …….
Estimate: >50 regulations will be
required to implement
Regulation development is underway
The process is designed for deliberation and input
• Public Consultations
• Congressional hearings
• Public Meetings
• Written comments
• Federal Register Notices – Requests for Comments
• WTO Notifications – https://tsapps.nist.gov/notifyus
• Trade Advisory Committees
• USDA
• Department of Commerce
• White House
• Meetings with U.S. Officials Upon Request – Open and
Transparent
• Global input allowed
www.gmaonline.org
There is also internal
oversight on the
process
Executive Order 12866
states that OMB must:
• Review regulations:
• Inconsistencies
• Incompatibilities
• Duplication
• Review cost/benefit
• Review alternatives
GMA Food Safety Modernization Program
Food Safety Modernization Steering Group
Food Safety Modernization ProgramTopic Principal: Leon Bruner
GMA Staff Project Leader: Shannon Cole
Rules and RegulationsCo-Sponsor: S. Geisert
Co-Sponsor: O. Mignot
GMA Staff Lead: S. Cole
Guidance DevelopmentSponsor: P. Barone
WG Chair: R. Reinhard
GMA Staff Lead: S. Cole
Education and TrainingSponsor: D. Mastrorocco
WG Chair: R. Petran & K. Kastrup
GMA Staff Lead: G. Black
International IntegrationWG Chair: B. Eldridge
GMA Staff Lead: C. Stacy
GMA Membership
SupportCo-Sponsor: H, Chin
Co-Sponsor: M. Robach
GMA Staff Lead: S. Cole
Preventive Controls
& Records AccessWG Co-Chair: T. Jackson
WG Co-Chair: D. Bresnahan
GMA Staff Lead: W. Stone
Supply Chain Mngm’t (Foreign & Domestic)
WG Chair: B. Welshons
WG Co-Chair: J. Scimeca
GMA Staff Lead: F. Ataei &
J. Dages
Inspections &
EnforcementWG Chair: P. Harvey
WG Co-Chair: D. Baldwin
GMA Staff Lead: L. Hontz
Import CertificationWG Chair: R. DePalma
WG Co-Chair: M. Overland
GMA Staff Lead: F. Ataei &
J. Dages
FSL Educational
Programs
New Training
Programs
New Publications
APEC PTIN
Integration
TPP Integration
Non-APEC Country
Integration
Guidance
Dev. Strategy
Hazard Analysis
Toolbox
Guidance
Document review
and comment
Communication
Strategy
Marketing
Strategy
Retail
Strategy
Foreign Supplier
Verification Program
Voluntary Qualified
Importer Program
Hazard Analysis & Risk
Based Prev. Controls
Records Access
Risk Based
Inspections
Registration &
Suspension
Re-inspection
Fees
Laboratory
Accreditation
Performance
Standards
Sanitary
Transportation
Mandatory Recall &
Detention of Food
Reportable Food
Registry
Import
Certifications
Foreign Facility
InspectionsAccreditation of 3
rd
Party Auditors
GMA FSM Policy Development Program Organizational Sub-Projects
Wednesday, September 05, 2012
Codex Guidance
Integration
Accreditation of
Foreign Gov’ts
Science Forum
Strategy
Food DefenseWG Chair: S. Mavity
WG Co-Chair: TBD
GMA Staff Lead: W. Stone
Intentional
Contamination Prev.
Food Defense Plans
Smuggled Foods
Food Safety Modernization
Task ForceGMA Staff Lead: S. Cole
Verification Steps/
Testing Domestic Supply
Chain Mngm’t
Traceability &
ProduceWG Chair: S. Mavity
WG Co-Chair: TBD
GMA Staff Lead: C Balestrini
Standards for
Produce Safety
Tracking & Tracing
SRAC Executive Committee
Regulatory AuditsEconomic
Adulteration
Big Picture
IFT Pilot Programs
Food Safety Modernization
CoalitionGMA Staff Lead: S. Cole
FSMA Implementation Concerns
• Stakeholders provide input in rule-making process
• Based on practical experience
• Processes known to work
• Analyze proposed rules and address issues
• Establish collaborations with key stakeholders to address critical issues (e.g. FDA, USDA, FAS, USTR,
Chamber of Commerce, etc.)
Regulations are prescriptive, not cost
effective, &/or not enforceable
Foreign Supplier Verification Program
3rd Party Certification and Accreditation
Concern Mitigation
What Businesses Are Doing Now
• Updating Food Safety and Food Defense Plans • Hazard analysis • Preventive controls • Verification, including testing
• Updating Supply Chain Management Programs • Domestic • Foreign
• Reviewing Records Maintenance & Access Procedures • Routine • Under Bioterrorism Act
21
Businesses are Moving Forward on
Implementation
What GMA is doing to help…
• Publications
• Webinars
• Classroom training
• Individual consultation
www.gmaonline.org
GMA Technical Services are available to
members
• FSMA-related capabilities
• Food safety plan development
• Preventive controls implementation
• Process validation and verification
• Foreign supplier verification
• Auditing procedures and records inspection
• Product Safety
• Ingredient Safety Reviews
• Microbiological Safety Reviews
• Regulatory Compliance Assessment
• Laboratory Services
• Microbiology
• Analytical Chemistry
• Forensic Analysis
• Process Authority
• Recall Consultation
• Food Defense Planning
Connecting Sound Science and Responsible Solutions Science Forum GROCERY MANUFACTURERS ASSOCIATION
April 1-5 in
Washington, D.C.
www.GMAScienceForum.com
www.gmaonline.org
Thank you for your interest!
Contact Information:
Leon H. Bruner, DVM, PhD
Senior Vice President, Science and Regulatory Affairs
Grocery Manufacturers Association
(202) 639-5954
Shannon Cole, MS, PMP
Senior Director, Science Program Management
Grocery Manufacturers Association
(202) 639-5979
32
Washington DC | New York | Denver | Seattle
Seafood HACCP: What Have We Learned?
Lisa Weddig
National Fisheries Institute
Who is NFI?
• Nation’s leading advocacy organization for the seafood industry.
• NFI’s members represent every element of the industry
• fishing vessels
• processors
• importers
• restaurant and retail chains
• NFI and members support and promote sound public policy based on science.
“Seafood HACCP Regulation”
Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
21 CFR 123
• Proposed: January 28, 1994
• Final rule: December 18, 1995
• Implementation: December 18, 1997
Who is Covered?
Processor means any person engaged in commercial, custom, or institutional processing of fish or fishery products, either in the United States or in a foreign country.
What is Covered?
Processing means, with respect to fish or fishery products: Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding.
What is Not Covered?
• Harvesting or transporting fish or fishery products, without otherwise engaging in processing.
• Practices such as heading, eviscerating, or freezing intended solely to prepare a fish for holding on board a harvest vessel.
• The operation of a retail establishment.
Endorsement for Seafood HACCP
Food Safety Modernization Act - FSMA
FSMA
Sec. 103 Hazard Analysis & Risk-Based Preventive Controls Sec. 301 Foreign Supplier Verification Program
Parallels
Seafood HACCP
21 CFR 123.6
(a)Hazard analysis.
(b)The HACCP plan
21 CFR 123.12 – Special Requirements for Imported Products
FSMA
Sec. 103
(b) Hazard Analysis
(c) Preventive Controls
Sec. 301 Foreign supplier Verification Program
FDA on FSMA
The legislation transforms FDA’s approach to food safety from a system that far too often responds to outbreaks rather than prevents them. It does so by requiring food facilities to evaluate the hazards in their operations, implement and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary.
Seafood HACCP - What is Required
• Conduct a hazard analysis • hazards that are reasonably likely to occur
specific for each product and process
• Develop and implement a HACCP plan • List hazards, critical control points, critical
limits, monitoring activities/records and verification procedures.
• Take corrective actions • Keep records of monitoring, corrective
actions, verification • Monitor 8 key sanitation control
procedures
LESSONS LEARNED
BE PREPARED
Implementation takes time
• Industry – Processors, domestic and foreign
• FDA – Inspection system
• Industry - Importers
Importer Requirements
• Written Import Verification Procedures:
−specifications that are designed to ensure that all imported products are not adulterated as defined by the Act.
−affirmative steps that will be taken to ensure that products being offered for entry are actually produced under controls that meet U.S. Seafood HACCP regulations.
−the maintenance of records documenting the affirmative steps taken.
Options for Affirmative Steps
• Obtain foreign processor HACCP and sanitation monitoring records for each lot.
• Obtain either a continuing or lot-by-lot certificate from the foreign government inspection authority or competent third party certifying that the product was processed in accordance with the HACCP regulations.
• Regularly inspect the supplier’s processing facilities to ensure that the product is processed in accordance with the HACCP regulation.
• Maintain a copy of the processor’s HACCP plan along with a written guarantee that the product is processed in accordance with the regulation.
• Periodically test the imported seafood products and maintain a written guarantee that product is processed in accordance with the regulation.
BE AWARE
Failure = Adulteration
• … your Ready to Eat Canned Pasteurized Crabmeat, vacuum packed Smoke Salmon, Ready to Eat Smoked Whitefish Salad, Fresh Jumbo Lump and Cooked Crabmeat products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Contents of the regulation
While HACCP plans are required only if the hazard analysis identifies a hazard that is reasonably likely to occur;
All processors are required to comply with the sanitation control provisions of the regulations
Contents of the regulation
• Conduct a hazard analysis • hazards that are reasonably likely to
occur specific for each product and process
• Develop and implement a HACCP plan • List hazards, critical control points,
critical limits, monitoring activities/records and verification procedures.
Contents of the regulation
Specific record requirements:
-name/location of processor,
-date/time of activity,
-signature of person doing activity,
-product identity and code, if applicable
-information entered at time observed
-actual values and observations
Contents of the regulation
Specific corrective action requirements:
-steps to be taken and responsibility
assigned to ensure
- no product enters commerce
- cause of deviation is corrected
FDA Warning Letter
The HACCP plan fails to include a corrective action for regaining control over the operation after a critical limit deviation. FDA recommends discontinuing the use of the supplier until evidence is obtained that the supplier’s practices have improved.
GUIDANCE IS MORE THAN JUST GUIDANCE
Fish and Fishery Products Hazards and Controls Guidance 4th Edition - April 2011
“Guidance” Disclaimer
This guidance represents the agency's current thinking on the hazards associated with fish and fishery products and appropriate controls for those hazards. … An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
LEARN FROM OTHERS
• … ready-to-eat salt-cured herring fillets in oil lists critical limits …“Temperature at Receiving” critical control point that are not adequate to control histamine formation and pathogen growth, including C. botulinum growth and toxin formation…
• … did not record monitoring observations at the receiving and product storage CCPs to control the significant hazard of histamine formation as listed in your HACCP plan for “Fresh, Whole Filleted or Loined Tuna […] Escolar and Wahoo.” …
Your firm does not have written HACCP plans for the receipt and subsequent refrigerated storage of canned, pasteurized crabmeat and ready-to-eat seafood salads containing shrimp, tuna or surimi. …
A HACCP REGULATION IS NOT REGULAR HACCP
Reasonably Likely to Occur
The Seafood HACCP Regulation defines a food safety hazard that is reasonably likely to occur as “one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls.
When is a Hazard RLTO
You may already have effective controls in place for a number of these hazards as part of your routine or traditional handling practices.
When is a Hazard RLTO
The presence of such controls does not mean that the hazard is not significant. The likelihood of a hazard occurring should be judged in the absence of controls.
When is a Hazard RLTO
For example, the fact that scombrotoxin (histamine) development in a particular species of fish has not been noted may be the result of (1) the inability of the fish to produce histamine or (2) the existence of controls that are already in place to prevent its development (e.g., harvest vessel time and temperature controls). In the first case, the hazard is not reasonably likely to occur. In the second case, the hazard is reasonably likely to occur, and the controls should be included in the HACCP plan.
Regulatory Application
The Seafood HACCP Regulation defines a food safety hazard that is reasonably likely to occur as “one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls.
ENFORCEMENT CAN HAPPEN WITHOUT FACILITY INSPECTION
Enforcement without Inspection
… a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer in the United States: … That importer was found to be importing Frozen Cooked Shrimp from your processing facility. During the inspection of that importer, we collected a copy of your firm’s HACCP plan for your “Frozen Cooked shrimp”. Our evaluation of that HACCP plan (copy attached) revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
Washington DC | New York | Denver | Seattle
Thank you
Import Alerts
• Import Alert #16-120
• Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP
• Import Alert # 16-119
• Detention Without Physical Examination Of Fish And Fishery Products For Importer And Foreign Processor (Manuf) Combinations
Food Safety Modernization Act: Industry
Implementation
IFT Food Policy Impact
December 6, 2012
Leon H. Bruner, DVM, PhD
Senior Vice President, Science and Regulatory Affairs
Today’s Discussion
• Brief introduction to GMA
• GMA Support for Passage of FSMA
• GMA Support in Pre-Rulemaking Process
• Preparing the Industry for FSMA
• Questions and Answers
2
www.gmaonline.org
The Grocery Manufacturers Association
• Represent the world’s leading food, beverage and
consumer product companies
• Provide leadership in food safety based on
scientific excellence
• Promote science-based public policy and
champions initiatives for productivity and growth
www.gmaonline.org *Represents a sample of GMA members
GMA Members
General Members
Associate Members
Industry Goal
Deliver safe, quality products that customers trust and want to serve their families
We work with all interested parties to foster
implementation of effective transparent safety systems that ensure production of safe foods that
consumers trust
FSMA came from the Four Pillars
Developed by GMA in 2007
Mandatory Foreign Supplier Quality
Assurance Program
Voluntary Qualified Importer
Food Safety Program
Capability Building
Foreign Focus
Capability Building US
Border Focus
www.gmaonline.org
A broad consortium of
stakeholders
supported FSMA
The Legislative Process
Food Safety Modernization Act
Signed January 4, 2011
www.gmaonline.org
Who and what will FSMA affect?
Size of the Food Industry
• Processed food sales
approximately $3.2 trillion
• 16.5 million employees
• >100,000 food producing
facilities in US alone
• Many, many more foreign
facilities
Range of Foods Impacted
• Fresh Produce
• Frozen Foods
• Processed Foods
• Dry Goods
• Confectionaries
• Infant Foods
• Spices
• …….
Estimate: >50 regulations will be
required to implement
Regulation development is underway
The process is designed for deliberation and input
• Public Consultations
• Congressional hearings
• Public Meetings
• Written comments
• Federal Register Notices – Requests for Comments
• WTO Notifications – https://tsapps.nist.gov/notifyus
• Trade Advisory Committees
• USDA
• Department of Commerce
• White House
• Meetings with U.S. Officials Upon Request – Open and
Transparent
• Global input allowed
www.gmaonline.org
There is also internal
oversight on the
process
Executive Order 12866
states that OMB must:
• Review regulations:
• Inconsistencies
• Incompatibilities
• Duplication
• Review cost/benefit
• Review alternatives
GMA Food Safety Modernization Program
Food Safety Modernization Steering Group
Food Safety Modernization ProgramTopic Principal: Leon Bruner
GMA Staff Project Leader: Shannon Cole
Rules and RegulationsCo-Sponsor: S. Geisert
Co-Sponsor: O. Mignot
GMA Staff Lead: S. Cole
Guidance DevelopmentSponsor: P. Barone
WG Chair: R. Reinhard
GMA Staff Lead: S. Cole
Education and TrainingSponsor: D. Mastrorocco
WG Chair: R. Petran & K. Kastrup
GMA Staff Lead: G. Black
International IntegrationWG Chair: B. Eldridge
GMA Staff Lead: C. Stacy
GMA Membership
SupportCo-Sponsor: H, Chin
Co-Sponsor: M. Robach
GMA Staff Lead: S. Cole
Preventive Controls
& Records AccessWG Co-Chair: T. Jackson
WG Co-Chair: D. Bresnahan
GMA Staff Lead: W. Stone
Supply Chain Mngm’t (Foreign & Domestic)
WG Chair: B. Welshons
WG Co-Chair: J. Scimeca
GMA Staff Lead: F. Ataei &
J. Dages
Inspections &
EnforcementWG Chair: P. Harvey
WG Co-Chair: D. Baldwin
GMA Staff Lead: L. Hontz
Import CertificationWG Chair: R. DePalma
WG Co-Chair: M. Overland
GMA Staff Lead: F. Ataei &
J. Dages
FSL Educational
Programs
New Training
Programs
New Publications
APEC PTIN
Integration
TPP Integration
Non-APEC Country
Integration
Guidance
Dev. Strategy
Hazard Analysis
Toolbox
Guidance
Document review
and comment
Communication
Strategy
Marketing
Strategy
Retail
Strategy
Foreign Supplier
Verification Program
Voluntary Qualified
Importer Program
Hazard Analysis & Risk
Based Prev. Controls
Records Access
Risk Based
Inspections
Registration &
Suspension
Re-inspection
Fees
Laboratory
Accreditation
Performance
Standards
Sanitary
Transportation
Mandatory Recall &
Detention of Food
Reportable Food
Registry
Import
Certifications
Foreign Facility
InspectionsAccreditation of 3
rd
Party Auditors
GMA FSM Policy Development Program Organizational Sub-Projects
Wednesday, September 05, 2012
Codex Guidance
Integration
Accreditation of
Foreign Gov’ts
Science Forum
Strategy
Food DefenseWG Chair: S. Mavity
WG Co-Chair: TBD
GMA Staff Lead: W. Stone
Intentional
Contamination Prev.
Food Defense Plans
Smuggled Foods
Food Safety Modernization
Task ForceGMA Staff Lead: S. Cole
Verification Steps/
Testing Domestic Supply
Chain Mngm’t
Traceability &
ProduceWG Chair: S. Mavity
WG Co-Chair: TBD
GMA Staff Lead: C Balestrini
Standards for
Produce Safety
Tracking & Tracing
SRAC Executive Committee
Regulatory AuditsEconomic
Adulteration
Big Picture
IFT Pilot Programs
Food Safety Modernization
CoalitionGMA Staff Lead: S. Cole
FSMA Implementation Concerns
• Stakeholders provide input in rule-making process
• Based on practical experience
• Processes known to work
• Analyze proposed rules and address issues
• Establish collaborations with key stakeholders to address critical issues (e.g. FDA, USDA, FAS, USTR,
Chamber of Commerce, etc.)
Regulations are prescriptive, not cost
effective, &/or not enforceable
Foreign Supplier Verification Program
3rd Party Certification and Accreditation
Concern Mitigation
What Businesses Are Doing Now
• Updating Food Safety and Food Defense Plans • Hazard analysis • Preventive controls • Verification, including testing
• Updating Supply Chain Management Programs • Domestic • Foreign
• Reviewing Records Maintenance & Access Procedures • Routine • Under Bioterrorism Act
21
Businesses are Moving Forward on
Implementation
What GMA is doing to help…
• Publications
• Webinars
• Classroom training
• Individual consultation
www.gmaonline.org
GMA Technical Services are available to
members
• FSMA-related capabilities
• Food safety plan development
• Preventive controls implementation
• Process validation and verification
• Foreign supplier verification
• Auditing procedures and records inspection
• Product Safety
• Ingredient Safety Reviews
• Microbiological Safety Reviews
• Regulatory Compliance Assessment
• Laboratory Services
• Microbiology
• Analytical Chemistry
• Forensic Analysis
• Process Authority
• Recall Consultation
• Food Defense Planning
Connecting Sound Science and Responsible Solutions Science Forum GROCERY MANUFACTURERS ASSOCIATION
April 1-5 in Washington, D.C.
www.GMAScienceForum.com
www.gmaonline.org
Thank you for your interest!
Contact Information:
Leon H. Bruner, DVM, PhD
Senior Vice President, Science and Regulatory Affairs
Grocery Manufacturers Association
(202) 639-5954
Shannon Cole, MS, PMP
Senior Director, Science Program Management
Grocery Manufacturers Association
(202) 639-5979
32
Washington DC | New York | Denver | Seattle
Seafood HACCP: What Have We Learned?
Lisa Weddig
National Fisheries Institute
Who is NFI?
• Nation’s leading advocacy organization for the seafood industry.
• NFI’s members represent every element of the industry
• fishing vessels
• processors
• importers
• restaurant and retail chains
• NFI and members support and promote sound public policy based on science.
“Seafood HACCP Regulation”
Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
21 CFR 123
• Proposed: January 28, 1994
• Final rule: December 18, 1995
• Implementation: December 18, 1997
Who is Covered?
Processor means any person engaged in commercial, custom, or institutional processing of fish or fishery products, either in the United States or in a foreign country.
What is Covered?
Processing means, with respect to fish or fishery products: Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding.
What is Not Covered?
• Harvesting or transporting fish or fishery products, without otherwise engaging in processing.
• Practices such as heading, eviscerating, or freezing intended solely to prepare a fish for holding on board a harvest vessel.
• The operation of a retail establishment.
Endorsement for Seafood HACCP
Food Safety Modernization Act - FSMA
FSMA
Sec. 103 Hazard Analysis & Risk-Based Preventive Controls Sec. 301 Foreign Supplier Verification Program
Parallels
Seafood HACCP
21 CFR 123.6
(a)Hazard analysis.
(b)The HACCP plan
21 CFR 123.12 – Special Requirements for Imported Products
FSMA
Sec. 103
(b) Hazard Analysis
(c) Preventive Controls
Sec. 301 Foreign supplier Verification Program
FDA on FSMA
The legislation transforms FDA’s approach to food safety from a system that far too often responds to outbreaks rather than prevents them. It does so by requiring food facilities to evaluate the hazards in their operations, implement and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary.
Seafood HACCP - What is Required
• Conduct a hazard analysis • hazards that are reasonably likely to occur
specific for each product and process
• Develop and implement a HACCP plan • List hazards, critical control points, critical
limits, monitoring activities/records and verification procedures.
• Take corrective actions • Keep records of monitoring, corrective
actions, verification • Monitor 8 key sanitation control
procedures
LESSONS LEARNED
BE PREPARED
Implementation takes time
• Industry – Processors, domestic and foreign
• FDA – Inspection system
• Industry - Importers
Importer Requirements
• Written Import Verification Procedures:
−specifications that are designed to ensure that all imported products are not adulterated as defined by the Act.
−affirmative steps that will be taken to ensure that products being offered for entry are actually produced under controls that meet U.S. Seafood HACCP regulations.
−the maintenance of records documenting the affirmative steps taken.
Options for Affirmative Steps
• Obtain foreign processor HACCP and sanitation monitoring records for each lot.
• Obtain either a continuing or lot-by-lot certificate from the foreign government inspection authority or competent third party certifying that the product was processed in accordance with the HACCP regulations.
• Regularly inspect the supplier’s processing facilities to ensure that the product is processed in accordance with the HACCP regulation.
• Maintain a copy of the processor’s HACCP plan along with a written guarantee that the product is processed in accordance with the regulation.
• Periodically test the imported seafood products and maintain a written guarantee that product is processed in accordance with the regulation.
BE AWARE
Failure = Adulteration
• … your Ready to Eat Canned Pasteurized Crabmeat, vacuum packed Smoke Salmon, Ready to Eat Smoked Whitefish Salad, Fresh Jumbo Lump and Cooked Crabmeat products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Contents of the regulation
While HACCP plans are required only if the hazard analysis identifies a hazard that is reasonably likely to occur;
All processors are required to comply with the sanitation control provisions of the regulations
Contents of the regulation
• Conduct a hazard analysis • hazards that are reasonably likely to
occur specific for each product and process
• Develop and implement a HACCP plan • List hazards, critical control points,
critical limits, monitoring activities/records and verification procedures.
Contents of the regulation
Specific record requirements:
-name/location of processor,
-date/time of activity,
-signature of person doing activity,
-product identity and code, if applicable
-information entered at time observed
-actual values and observations
Contents of the regulation
Specific corrective action requirements:
-steps to be taken and responsibility
assigned to ensure
- no product enters commerce
- cause of deviation is corrected
FDA Warning Letter
The HACCP plan fails to include a corrective action for regaining control over the operation after a critical limit deviation. FDA recommends discontinuing the use of the supplier until evidence is obtained that the supplier’s practices have improved.
GUIDANCE IS MORE THAN JUST GUIDANCE
Fish and Fishery Products Hazards and Controls Guidance 4th Edition - April 2011
“Guidance” Disclaimer
This guidance represents the agency's current thinking on the hazards associated with fish and fishery products and appropriate controls for those hazards. … An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
LEARN FROM OTHERS
• … ready-to-eat salt-cured herring fillets in oil lists critical limits …“Temperature at Receiving” critical control point that are not adequate to control histamine formation and pathogen growth, including C. botulinum growth and toxin formation…
• … did not record monitoring observations at the receiving and product storage CCPs to control the significant hazard of histamine formation as listed in your HACCP plan for “Fresh, Whole Filleted or Loined Tuna […] Escolar and Wahoo.” …
Your firm does not have written HACCP plans for the receipt and subsequent refrigerated storage of canned, pasteurized crabmeat and ready-to-eat seafood salads containing shrimp, tuna or surimi. …
A HACCP REGULATION IS NOT REGULAR HACCP
Reasonably Likely to Occur
The Seafood HACCP Regulation defines a food safety hazard that is reasonably likely to occur as “one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls.
When is a Hazard RLTO
You may already have effective controls in place for a number of these hazards as part of your routine or traditional handling practices.
When is a Hazard RLTO
The presence of such controls does not mean that the hazard is not significant. The likelihood of a hazard occurring should be judged in the absence of controls.
When is a Hazard RLTO
For example, the fact that scombrotoxin (histamine) development in a particular species of fish has not been noted may be the result of (1) the inability of the fish to produce histamine or (2) the existence of controls that are already in place to prevent its development (e.g., harvest vessel time and temperature controls). In the first case, the hazard is not reasonably likely to occur. In the second case, the hazard is reasonably likely to occur, and the controls should be included in the HACCP plan.
Regulatory Application
The Seafood HACCP Regulation defines a food safety hazard that is reasonably likely to occur as “one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls.
ENFORCEMENT CAN HAPPEN WITHOUT FACILITY INSPECTION
Enforcement without Inspection
… a representative of the United States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer in the United States: … That importer was found to be importing Frozen Cooked Shrimp from your processing facility. During the inspection of that importer, we collected a copy of your firm’s HACCP plan for your “Frozen Cooked shrimp”. Our evaluation of that HACCP plan (copy attached) revealed serious deviations from the requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
Washington DC | New York | Denver | Seattle
Thank you
Import Alerts
• Import Alert #16-120
• Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP
• Import Alert # 16-119
• Detention Without Physical Examination Of Fish And Fishery Products For Importer And Foreign Processor (Manuf) Combinations
