The Food Safety Preventive Control Alliance (FSPCA):A Public-Private Partnership to Assist Food Industry Compliance with the Preventive Controls regulations
Glenn BlackPurnendu C. Vasavada
Gerald Wojtala
AFDO PRE-CONFERENCE WORKSHOP:
TRAINING ESSENTIALS – ARE YOU PREPARED?
JUNE 2, 2012
FSPCA- Industry Involvement and Response
Glenn Black, Ph.D.Director of Science Operations, Food Protection
GMAChair, FSPC Executive CommitteeChair, FSPC Steering Committee
Agenda
� FSPCA Introduction and Industry involvement and Response - Glenn Black
� FSMA and FSPCA
� FSPCA – Objectives, Governance, and deliverables - P. C. Vasavada
� FSPCA- Training design and development - Gerald Wojtala
� To discuss industry involvement and response to FSMA and FSPCA
� To discuss the FSPCA – mission and objectives, governance, outcomes and deliverables and progress to so far
� To discuss main aspects of the FSPCA training and curriculum
� Summary
Objective
FSMA is historical..
� 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
Main Themes of FSMA
Prevention
Inspections,
Compliance, &
Response
Import Safety
Enhanced
Partnerships
FSPCA- Industry Involvement and Response
The Alliance will solicit response:
� Through trade associations� Directly to companies of interest� Through university extension
� Very small companies
� FDA news releases and IFSH website
FSPCA- Industry Engagement
General Development Process:
� Define Working Group structure� Assign Liaison from Steering Committee
� Provide basic goals & deliverables� Allowing for WG input
� Provide references and seed material� Seek guidance from FDA
� As material is developed to ensure alignment
FSPCA- Working Group Expansion
As curriculum development progresses:� Continuing alignment
� As regulations are released
� WG expansion when needed� Training preview to select groups� Guidance development
� From basic curriculum outline & materials
FSPCA – Objectives, Governance, and deliverables
Purnendu C. Vasavada, Ph.D.FDA – ORISE Fellow
Professor Emeritus- UW River FallsCoordinator,
Food Safety Preventive Controls Alliance
Food
Safety
Preventive
Controls
Alliance
� TITLE I--IMPROVING CAPACITY TO
PREVENT FOOD SAFETY PROBLEMS
- Sec. 103 Hazard analysis and risk-
based preventive controls.
� FSMA requires compliance with
the preventive controls rule.
� Understanding and compliance
with the preventive controls rule
will require education.
FSMA and FSPCA
Hazard Analysis and Preventive Controls/
Food Safety Plans
� Each registered facility would be required to:
�Conduct a hazard evaluation to identify known or
reasonably foreseeable hazards
�Put in place controls to significantly reduce or prevent
hazards
�Monitor the controls, establish corrective actions, and
verify that the plan is working
� verification to include environmental and finished
product testing
� Undergo a hazard re-evaluation every three years
� Provide FDA with a written food safety plan and related
records during an inspection
Industry Needs Help
�How do I do a hazard analysis?
�What hazards are associated with my product?
�Are the controls in my process adequate to
control the hazards associated with my
product?
�What do I need to do that I am not already
doing?
FSPCA � What is FSPCA and Why was it established?
� Food industry, particularly small and medium
companies, may need assistance in understanding the
technical elements of regulations and compliance with
the FSMA requirements.
� FSPCA is a public-private Alliance designed to fulfill this
need.
� It was established by a grant from the FDA to the
Institute for Food Safety and Health (IFSH) at the Illinois
Institute of Technology, Bedford Park IL.
FSPCA Mission and Scope � Develop Food Safety Preventive Controls training
curriculum and modules for food industry personnel,
including a train-the-trainer module for industry food
safety personnel
� Develop delivery mechanisms for FSPC training modules
for the food industry
� Communicate to industry the scientific and technical
elements relevant to the hazard analysis and preventive
controls aspects of the Preventive Controls rule
� Help provide interpretation and guidance for assessing
food hazards and verification tools for preventive controls
for major industry sectors and educational resources for
small and medium-sized companies
FSPCA Governance and Structure
� Executive Committee-Alliance Business
� Steering Committee - key stakeholders with representation from regulatory, academia and industry trade associations.
� Subcommittees and Working Groups – subject matter experts volunteers from all 3 groups –specific food companies encouraged to join WGs.
� FSPCA Coordinator Dr. (PC) Vasavada
FSPCA Working Groups*� Volunteers from industry, academia and FDA..
Five initial working groups have been created:� Hazard Identification and Preventive Controls Curriculum
Development
� Food Categories and Representative Processing
� Allergen Management and Control
� Sanitation, Current Good Manufacturing Practices and
Environmental Monitoring
� Supply Chain and Ingredient Management
* Other WGs may be formed as necessary
FSPCA - Outcomes and Deliverables
�Training Curriculum: Development, delivery and facilitation of a standardized Food Safety Preventive Controls curriculum (with training slides).
�Technical Assistance Network: For the Food industry, with emphasis on small- and medium-sized companies.
�Hazards Guide: Commodity/industry sector-specific.
�Knowledge Gap Identification: Translation of and needs assessment for further enhancement in PC’s.
�Efficacy and impact of the FSPC Alliance programs.
Preventive Controls Education�FDA looks to the Alliance to develop a
standardized curriculum that provides the foundation for training providers who will train individuals to meet the requirements of the preventive controls regulation
�This effort is similar to those for existing preventive controls rules: seafood and juice HACCP
FSPCA-Based Standardized Curriculum*
� Hazard analysis – how to do one, where to get
information on hazards, examples of hazards associated with various foods covered by the regulation
� Preventive controls – how to identify appropriate
PCs, how to determine what parameters must be controlled and how to control them
� Monitoring – how to monitor preventive controls
� Corrective Actions – when and how to apply
� Verification – how to determine that PCs are “effectively and significantly minimizing or preventing the occurrence of identified hazards”
� Recordkeeping – types of records that document the food safety plan (and how to develop a plan)
*To be determined by FSPCA
FSPCA WG Liaisons, Chairs and Vice Chairs
WG Liaisons Chairs/Vice Chairs
Hazard Identification
and Preventive
Controls Curriculum
Development
Glenn Black (GMI)
Ben Chapman(NCSU)
Jeff Barcah
Judy Fraser Heaps
Food Categories and
Representative
Processing
Jason Wan (IIT/IFSH)
Jon Gardner (IDFA)
Kim Young (FDA)
Kurt Deibel (Heinz )
Alejandro Mazzotta
(Campbell’s)
Allergen Management
and Control
Don Schaffner
(Rutgers)
Ram Rao (USDA-NIFA)
Joseph Scimeca
(Cargill)
Sue Estes(Pepsico)
FSPCA WG Liaisons, Chairs and Vice Chairs
WG Liaiosns Chairs/Vice Chairs
Sanitation, Current
Good Manufacturing
Practices and Environmental
David Gombas (United
Fresh)
David Fairfield (NGFA)
Lee Sanders (ABA)
John Allan (AFFI)
Joe Shebuski(Cargill)
Supply Chain and
Ingredient
Management
Donna Garren (AFFI)
John Hoffman (UMN)
Kim Young(FDA)
Steve Mavity (Bumble
Bee)
Faye Feldstein
(Deloitte)
The Curriculum is Just the Beginning
� For education/training to be effective, information on hazards and preventive controls specific to foods being produced by small businesses will be needed.
�Guidance documents
�Food-type specific training modules
� Compendium of methods as a safe harbor
� Analytical methods
�Process methods
Training
Guidance Documents
FSPCA – Progress so far..� FSPCA Executive Committee and Steering
Committee established
� Subcommittees formed
� FSPCA Website launched
� Your involvement and participation is invited!
� FSPCA Working Groups established
Steering Committee
Subcommittees
Working Groups
Executive Committee
E mail: [email protected]
http://www.iit.edu/ifsh/alliance/index.shtml
Visit FSPCA Website…http://www.iit.edu/ifsh/alliance/index.shtml
www.iit.edu/ifsh
IFSH home page
Click on FSPCA
Your involvement and Input is welcome!� Join working groups
� Share subject matter expertise and
educational material (case study, forms,
charts, best practice tips, etc.)
� Let us know how you can help
� Participate/respond to survey /
questionnaire
� Sign up for the FSPCA Update
FSPCA- Training design and development
Gerald Wojtala
International Food Protection Training Institute
Battle Creek, MI.
FSPCA Steering Committee
FSPC Curriculum Design and Development WG
FSPCA training course development
�Course design and development – a scientific
process
�Audience analysis - knowledge gap and needs
assessment
�Course inventory/ catalog
�Curriculum framework
�Course design, Delivery modes
� Instructor development
� Evaluation and Certification
Curriculum Framework
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Curriculum Framework
Course Design Document
� Mission/ content area
� Target Audience and Level
� Scope, Duration
�Resource requirements
�Reference list
� Instructor/student ratio
�Practical exercise statements
�Evaluation strategy
Course Outline that covers:
Target Audience
�~200,000 firms
�Small – medium sized firms?
�What level of employee?
� Sr. management
�Regulatory Affairs Specialist
�QA /QC Managers
�Front line employees
�Regulators
�Needs Survey
Who Needs to Demonstrate the Knowledge or Skill?
Delivery Format Considerations
�Utilize best modality needed to assure most efficient transfer of knowledge and skills
� Blended training formats
� Instructor-led, Distance learning
- Webinars, computer based learning, pod casts, videoconferencing, etc.
� Case Studies
� Exercises
�Additional Resources (model plans?)
Evaluation of Training Effectiveness
� Kirkpatrick’s 4 Levels
To what degree targeted outcomes occur
To what degree participants
acquire the intended KSA,
confidence, and commitment
To what degree participants
react favorably to the training
To what degree participants
apply what they learned when
they are back on the job
Type of AssessmentLevel 3 – how do measure if learning took place?
�Will be based on analysis considerations and could include:
�Pre & post tests
�Instructor observation
�Focus groups
�Interviews
�Skill demonstration
�Written plan
�Other appropriate methods
Training Support Package
�Instructor guide/ lesson plan
�Participant manual
�Audio/ visual materials
�Special support materials
�Comprehensive Hazards Guide
Instructors
� Universities/ extension and outreach
� Industry/ trade associations
� Private providers/ consultants
� In-house
� Agencies/ regulators
� International
Where will we find acceptable instructors and
do we need to incentivize them?
Your Input is invited !
� Join working groups
� Share subject matter expertise
� Participate in surveys and pilot training programs
(when organized) .
contact us at [email protected]
Summary� FSMA focus on assuring food safety through Hazard Analysis
and Risk-Based Preventive Controls (section 103).
� Recognized need to assist small- and medium-sized businesses with interpretation of the regulation, training and technical information to be compliant with the FSMA regulations
� FSPCA is an alliance of key stakeholders from academia, government, trade Associations, and other relevant organizations designed to assist the industry, especially small-and medium-sized businesses, in complying with the Preventive Controls regulations.
� FSPCA will serve the industry needs by developing standardized training and technical resources and providing a link between the FDA and food companies in communication of technical elements of FSMA
� The FSPCA welcomes your comments and suggestions
Acknowledgement� IFPTI and AFDO
� Dr. Bob Brackett (IFSH), Dr. Jenny Scott(FDA), Dr. John Larkin (FDA), and the FSPCA Steering Committee
For further information and questions -
Contact: [email protected]
Visit http://www.iit.edu/ifsh/alliance/index.shtml
THANK YOU !