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Preparing for New FSMA Preventive Controls
for Human Food Regulations
Perspective Webinar
August 25, 2015
Dr. Donna Garren, AFFI | Jeff Chilton, Alchemy Systems
Webinar Logistics
2
• Join audio:
– Choose “Mic & Speakers” to
use VoIP
– Choose “Telephone” to dial in
using info provided
• All lines are in listen-only mode
• Post your questions early and
often!
• A link to the webinar recording
will be emailed shortly after the
event
Today’s Speakers
3
Jeff Chilton
Alchemy
Diana Peña
Moderator
Dr. Donna Garren
American Frozen
Food Institute
Agenda
• New Regulatory Requirements Overview
• Process of Transitioning From HACCP To HARPC
• Tools for Compliance
• Q & A
5Confidential and Proprietary
New Regulatory Requirements
Overview
FDA’s FSMA Implementation Plan – A Continuum
Phase 1:
Set standards
Phase 2
Design strategies
to implement
standards
Phase 3:
Monitor,
evaluate, refresh
Stakeholder engagement throughout the process
Develop regulations,
guidance, & protocols
for new administrative
enforcement tools
Fully develop &
implement the
standards
Regulation Proposal Final
(consent decree)
Preventive Controls (Human Food)* Jan 16, 2013 Aug 30, 2015
Preventive Controls (Animal Food)* Oct 29, 2013 Aug 30, 2015
Produce Safety* Jan 16, 2013 Oct 31, 2015
Foreign Supplier Verification Program* Jul 29, 2013 Oct 31, 2015
Third Party Accreditation Jul 29, 2013 Oct 31, 2015
Sanitary Transport Feb 5, 2014 Mar 31, 2016
Intentional Adulteration Dec 24, 2013 May 31, 2016
*Supplemental proposals published September 2014
Phase I: Standard Setting
Transition to Phase 2: Implementation
• Teams continue rulemaking, guidance and other policy work
until completed
• Concurrently, workgroups:
– Implement the final rules, programs established through
guidance and other policy
– Design specific strategies, capacity building, training and
operation plans needed to implement FSMA
• Steering Committee oversees 5 workgroups:
– Preventive Controls in Food and Feed Facilities, Produce
Safety Standards, Import Oversight, Intentional
Adulteration, and Training
Operations and Policy Working Together
High Level FDA
Oversight
Internal Adulteration Import Controls
Preventive Controls
(human & animal
food)
Sanitary
Transportation
Produce Safety
Internal Advisory
Team
Steering Committee
ORA, CFSAN, CVM, and State representation
Reduced Risk of Illness Attributed to Food
From Facilities Subject to the PC Rule
8.2: More Effective
Inspection &
Enforcement
Program/
Protocol/Policy
Established
3: Increased Implementation by
Industry of PC Rule Requirements
2: Reduced Contamination of Food
From Facilities Subject to PC Rule
8.1: Increased
Knowledge by Food
Safety Staff of PC Rule
& Underlying Science
7: Increased Industry
Understanding of PC Rule and
the Underlying Science
8: More Effective and
Efficient Regulatory
Activities Related to
the PC Rule
6: Expanded
Voluntary
Compliance
and non-
Enforcement
Incentives
5: Increased
Acceptance by
Firms of their
Responsibility for
Meeting PC
Standards (for
Food Safety)
4: Increased
Transparency/Info
Exchange Related
to PC Rule for
Emerging Issues
Between Regulatory
Agencies, Public
Health Orgs &
Industry 8.3: Expanded
Risk-Based
Management of
Regulatory
Resources
8.3.2: Improved
Analytics to Assess
Risk
8.3.1: Increased Capture, Analysis,
Management, & Sharing of Enforcement &
Voluntary Corrective Relevant Information
1: More Rapid and Effective Recall
Actions by Facilities Subject to PC Rule
Draft Preventive Controls Results
Framework
8/25/14
A: Improved
IT
Infrastructure
and Systems
F: Research Better
Targeted to PC
Priorities
D: Improved
Collaboration Between
FDA, Regulatory
Partners & Industry
E: Increased Support for
Preventive Approach by
Stakeholders
B: Change in Culture of FDA &
Regulatory Partners from
Response to Prevention &
Provide a Continuum to
Achieve Voluntary Compliance
C: Expanded &
Improved
Outreach and
Education
5.1: Increased Availability
of PC Training, Guidance
Materials, and Technical
Assistance for Food Safety
Staff and Industry (learning
resources)
Key Results
Industry
Regulatory
New FDA Culture
• FSMA implementation is occurring just as FDA culture is
changing
• FDA is rapidly becoming:
– More inspection-oriented
– More enforcement-minded
11
Educate Before and While We Regulate
• Facilitate industry implementation of modern, preventive
practices through:
– Commodity and sector-specific guidance
– Education, outreach and technical assistance
– Regulatory incentives for compliance
New FDA Strategies
13
• FDA to develop inspection
cadre specially trained in and
devoted to food inspections
• Closer integration of field
inspections and CFSAN/
headquarters experts (in real
time)
• Distinct types of inspections by
staff with different technical
expertise
• Two-tiered inspections and
centralized records review
FDA is More Inspection-Oriented
• FDA is:
– Conducting more domestic inspections (with the states)
– More strategic about selecting inspection sites
– Posting some 483s on website
– Expanding definition of “high risk”
– Testing more, especially environmental testing
– Increasing oversight of imports, especially ingredients,
and conducting foreign on-site inspections
– Much more forceful in demanding access to records
regardless of current legal authority
Enforcement is on the Rise
• FDA is more critical and more
inclined to identify/find issues
• Increase in Warning Letters for
food adulteration based on food
inspections/GMPs
• Increase in court injunctions
• Heightened use of Import Alerts
• New authorities for mandatory
recalls and suspension of
registration are now in play
• Expanded use of Park Doctrine on
the horizon
What Does This Mean?
• FDA’s expectations are changing
• Inspections are changing
• Testing has increased
• Imported ingredients will face particular scrutiny
• Crackdowns will increase in frequency
Food companies need to
1) Know their rights
2) Adapt to these changes and be prepared!
16
17
Know Your Rights
• The FFDCA and implementing regulations specifically address the
records that FDA legally is entitled receive during an inspection
– When a general inspection, FDA currently has very limited access
to records
– Once Bioterrorism is invoked, records access is almost unlimited
• FDA must provide written notice that the inspection is under
the Bioterrorism statute
• FDA can ask (and frequently demands) it has the right to records
when no such authority exists
• Companies should know their rights and then make informed
decisions on whether they will voluntarily release additional
information
What does this mean for your next inspection?
• Inspections have already changed:
– FDA is energized and persistent and will note all possible violations as
inspectional observations
– FDA will demand access to records the agency lacks the legal authority
to access
– FDA will try hard to take photographs even without express legal
authority
– Inspections involve comprehensive environmental sampling (“swab-a-
thon”)
Note: Some states have additional legal authorities (e.g., records
access), so know your local rules
18
19
Inspectional Observations
• 483 Inspectional Observations
– A few years ago, investigators would note minor
observations orally but would not record them
– Today, minor observations are included in the Form 483
– Unusual for a company to escape an inspection without
receiving a 483
• FDA policy announced in August 2009 gives industry 15
business days to provide a response
• Absolutely essential to respond, in writing, to every 483
observation within the 15 period
Implications of FSMA for Inspections
New FDA culture
+
New records access authority
+
New tools
=
New inspection paradigm
(Starting September 2016)
20
FSMA: Systems-Based Approach
• Historically, FDA has inspected food facilities for basic
sanitation and to detect visible problems with the facility or
the product produced
– FDA has assessed compliance based on this “snapshot”
of the facility’s operations
• FSMA requires FDA to take a risk-based approach to facility
inspections
– Shift from reaction to prevention
21
Systems-Based Approach
• To implement FSMA’s risk-based inspection mandate, FDA
will focus on whether facilities are implementing the systems
needed to make safe food
• The “systems-based” approach is aimed at preventing
problems on a continuing basis, not just when the inspector
is in the facility
22
“Culture of Food Safety”
• FDA provided flexibility in the regulations in exchange for
facilities developing a “culture of food safety”
• FDA wants to assess whether a company has a “culture of
food safety” as a barometer of competence
• How can you demonstrate a culture of food safety?
– Employees understand their responsibilities and why
– You can explain your programs, the rationale behind
decisions
– With flexibility comes responsibility
23
Increased Records Access Authority
• FSMA provides FDA with greatly expanded access to records during
routine inspections
• This new authority facilitates the systems-based inspection approach
– Let’s FDA know how a company is operating when inspectors
aren’t present
– FDA will know what happened not just today, but last week, last
month, and last year!
• Records review will be a central component of FDA inspections
– Inspections will become more like an IRS audit
24
Implications of Records Access
25
• Companies decisions will be become
much more exposed to scrutiny by
inspectors
– Flexibility in FSMA proposed rules is
double edged sword: with it comes
responsibility
• If it isn’t documented, it didn’t
happen!
– “You are what your records say you
are”
What to Do NOW:
• Know your rights
• Start preparing for FSMA inspections
– Update your inspection manual
– Recordkeeping training -- apply good
record keeping practices
– Review audits for areas of
improvement
26
• Web site: http://www.fda.gov/fsma
• Subscription feature available
• Send questions to FSMA@fda.hhs.gov
For More Information
27
28
Transitioning from HACCP to HARPC
HACCP and HARPC Comparison
29
HACCP HARPC
Hazard Analysis Critical Control Point
Hazard Analysis Risk-Based Preventive
Controls
Global standard
U.S. standard incorporated into Food
Safety Modernization Act (FSMA)
Applies to low-acid, canned food,
juice, & seafood processors
Applies to almost all food processing
facilities
Traditional HACCP plan based on 7
principles of HACCP
Food Safety Plan – A Qualified
Individual Must Prepare and
Implement a Written Food Safety Plan
(117.126(a))
HARPC Written Plan Requirements - 117.126(b)
30
Food
Safety
Plan
Hazard
Analysis
Preventive
Controls
Supplier
Program
Recall
Program
Monitoring
Procedures
Corrective
Action
Procedures
Verification
Procedures
5 HARPC Mandates
31
• Hazard Analysis 117.130
• Preventive Controls 117.135
• Preventive Control Management Components 117.140
• Food Safety Plan Reanalysis 117.170
• Implementation Records Required 117.190
Hazard Analysis 117.130
32
• Identify and evaluate known or reasonably foreseeable hazards for each type of
food manufactured, processed, packed or held to determine whether there are
significant hazards
• Hazard Identification (1)
– Biological – Pathogens, Environmental Pathogens, Parasites
– Chemical – Radiological, Pesticides and Drug Residues, Natural Toxins, Decomposition,
Unapproved Food or Color Additives and Food Allergens
– Physical – Physical foreign materials
• Hazard Identification (2)
(i) Hazards that occur naturally
(ii) Hazards that may be unintentionally introduced
(iii) Hazards that may be intentionally introduced for economic gain
• Hazard Evaluation (2c)
(i) Hazards must be evaluated to assess severity of illness/injury and probability the
hazard will occur
(ii) Environmental pathogens whenever a RTE food is exposed prior to packaging
Hazard Analysis 117.30
33
Formulation of
the food
Condition, function and
design of the facility and
equipment
Raw materials
and ingredients
Transportation
Practices
Manufacturing /
Processing
Procedures
Packaging and
Labeling Activities
Storage and
Distribution
Intended or Reasonably
Foreseeable Use
Sanitation and
Employee Hygiene
Other Relevant
Factors
Hazard evaluation must consider
the effect of the following:
Preventive Controls 117.135
34
Process
Controls
Food
Allergen
Controls
Sanitation
Controls
Supplier
Controls
Recall
Plan
Other
Controls
• Controls established at Critical Control Points (CCPs), if they have been identified
• Controls are also appropriate at non-CCPs
Control parameters
and values for
processes such as
heat, refrigeration,
acidifying, irradiating
etc.
Protection and
labeling
Sanitary condition for
pathogen and
allergen control
Risk based for
significant hazard
ingredient
For food with a
significant hazard
Hygiene Training;
GMP’s
Preventive Control Management Components 117.140
35
Validation
Verification of
Monitoring
Verification of
Corrective
Actions
Verification of
Implementation
and
Effectiveness
Reanalysis
Monitoring: written procedures with adequate frequency documented on records
Corrective Action and Corrections: For pathogens, environmental pathogens and
unanticipated food safety problem
Scientific or technical
information prior to
implementation or
during first six weeks
of production
Conducted as
required
As required Calibration, product
testing,
environmental
monitoring, and
record reviews
3 years, changes,
unanticipated events,
FDA determination
Food Safety Plan Reanalysis 117.170
36
• Performed before change is
operative or during first 6
weeks of production when
necessary
• Revise the Food Safety Plan if
a significant change made or
document basis for no
revisions
• Performed by a qualified
individual
• FDA determines it is necessary
to respond to new hazards or
developments
Reanalysis
Once every 3
years
Significant
change made
Aware of new
info
Unanticipated
food safety issue
Preventative
control found
ineffective
Implementation Records Required 117.190
37
• Food Safety Plan
• Preventive Control Monitoring Records
• Corrective Action Records
• Verification Records
1. Validation records 5. Product Testing
2. Monitoring verification 6. Environmental Monitoring
3. Corrective Action verification 7. Records Review
4. Calibration records 8. Reanalysis records
• Training Records for Qualified Individuals who have had
HACCP/HARPC training certification
HACCP to HARPC Reassessments – Major Changes
38
• Creation of Food Safety Plan with all required components
• Reassessment of the Hazard Analysis for:
- Risk and severity evaluation of hazards
- Inclusion of radiological hazards
- Inclusion of unintentionally introduced hazards
- Inclusion of intentionally introduced hazards for
economic gain
• Identification of Preventive Controls and control measures
• Verification of Implementation Effectiveness Procedures –
product testing and environmental testing requirements
• Training requirement to be considered a qualified individual
39
Tools for Compliance
FDA Resources
40
• Web site: http://www.fda.gov/fsma
• FSMA Proposed Rule at a Glance
– http://www.fda.gov/downloads/Food/GuidanceRegulation/FSM
A/UCM412922.pdf
• Food Safety Modernization Act
– http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.ht
m
• FSMA Proposed Rule for Preventative Controls for Human Food
Detail
– http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm3341
15.htm
AFFI Resources
41
• FSMA Readiness Self Assessment Checklist
• Useful Industry Resource Available
• Available for purchase at www.affi.org
• http://www.affi.org/member-services/fsma-self-assessment-
tool
• AFFI Forum – October 19-22, 2015 Lake Geneva, WI
• AFFI Regulatory and Technical Support Assistance
Alchemy Professional Services Offerings
42
Training
HARPC Workshop based on
FDA recognized standardized
curriculum
• Public courses or on-site
• On-line courses coming
soon
Gap Analysis
• On site review to evaluate
existing programs, products
and facility to new
regulatory requirements
• Off site desk top review of
existing HACCP Plans
comparison to new
regulatory requirements
Development
Creation of new Food Safety
Plan documentation
customized for your products
and processes
Reanalysis
• Desk top review of client
created Food Safety Plan
• On Site Reanalysis to
validate food safety system
and written program
compliance
43
Q & A
Upcoming Events
44
• Network with industry leaders
• Master best practices
• Discover new technologies
http://www.alchemysystems.com/alchemy-conference/
Thank you!
Dr. Donna Garren
– dgarren@affi.com
– 703.821.0770
Jeff Chilton
– jeff.chilton@alchemysystems.com
– 706.483.4400
contactus@alchemysystems.com
www.alchemysystems.com/solutions/professional-services
The Feed: Alchemy Blog

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Preparing for New FSMA Preventive Controls Regulations

  • 1. Preparing for New FSMA Preventive Controls for Human Food Regulations Perspective Webinar August 25, 2015 Dr. Donna Garren, AFFI | Jeff Chilton, Alchemy Systems
  • 2. Webinar Logistics 2 • Join audio: – Choose “Mic & Speakers” to use VoIP – Choose “Telephone” to dial in using info provided • All lines are in listen-only mode • Post your questions early and often! • A link to the webinar recording will be emailed shortly after the event
  • 3. Today’s Speakers 3 Jeff Chilton Alchemy Diana Peña Moderator Dr. Donna Garren American Frozen Food Institute
  • 4. Agenda • New Regulatory Requirements Overview • Process of Transitioning From HACCP To HARPC • Tools for Compliance • Q & A
  • 5. 5Confidential and Proprietary New Regulatory Requirements Overview
  • 6. FDA’s FSMA Implementation Plan – A Continuum Phase 1: Set standards Phase 2 Design strategies to implement standards Phase 3: Monitor, evaluate, refresh Stakeholder engagement throughout the process Develop regulations, guidance, & protocols for new administrative enforcement tools Fully develop & implement the standards
  • 7. Regulation Proposal Final (consent decree) Preventive Controls (Human Food)* Jan 16, 2013 Aug 30, 2015 Preventive Controls (Animal Food)* Oct 29, 2013 Aug 30, 2015 Produce Safety* Jan 16, 2013 Oct 31, 2015 Foreign Supplier Verification Program* Jul 29, 2013 Oct 31, 2015 Third Party Accreditation Jul 29, 2013 Oct 31, 2015 Sanitary Transport Feb 5, 2014 Mar 31, 2016 Intentional Adulteration Dec 24, 2013 May 31, 2016 *Supplemental proposals published September 2014 Phase I: Standard Setting
  • 8. Transition to Phase 2: Implementation • Teams continue rulemaking, guidance and other policy work until completed • Concurrently, workgroups: – Implement the final rules, programs established through guidance and other policy – Design specific strategies, capacity building, training and operation plans needed to implement FSMA • Steering Committee oversees 5 workgroups: – Preventive Controls in Food and Feed Facilities, Produce Safety Standards, Import Oversight, Intentional Adulteration, and Training
  • 9. Operations and Policy Working Together High Level FDA Oversight Internal Adulteration Import Controls Preventive Controls (human & animal food) Sanitary Transportation Produce Safety Internal Advisory Team Steering Committee ORA, CFSAN, CVM, and State representation
  • 10. Reduced Risk of Illness Attributed to Food From Facilities Subject to the PC Rule 8.2: More Effective Inspection & Enforcement Program/ Protocol/Policy Established 3: Increased Implementation by Industry of PC Rule Requirements 2: Reduced Contamination of Food From Facilities Subject to PC Rule 8.1: Increased Knowledge by Food Safety Staff of PC Rule & Underlying Science 7: Increased Industry Understanding of PC Rule and the Underlying Science 8: More Effective and Efficient Regulatory Activities Related to the PC Rule 6: Expanded Voluntary Compliance and non- Enforcement Incentives 5: Increased Acceptance by Firms of their Responsibility for Meeting PC Standards (for Food Safety) 4: Increased Transparency/Info Exchange Related to PC Rule for Emerging Issues Between Regulatory Agencies, Public Health Orgs & Industry 8.3: Expanded Risk-Based Management of Regulatory Resources 8.3.2: Improved Analytics to Assess Risk 8.3.1: Increased Capture, Analysis, Management, & Sharing of Enforcement & Voluntary Corrective Relevant Information 1: More Rapid and Effective Recall Actions by Facilities Subject to PC Rule Draft Preventive Controls Results Framework 8/25/14 A: Improved IT Infrastructure and Systems F: Research Better Targeted to PC Priorities D: Improved Collaboration Between FDA, Regulatory Partners & Industry E: Increased Support for Preventive Approach by Stakeholders B: Change in Culture of FDA & Regulatory Partners from Response to Prevention & Provide a Continuum to Achieve Voluntary Compliance C: Expanded & Improved Outreach and Education 5.1: Increased Availability of PC Training, Guidance Materials, and Technical Assistance for Food Safety Staff and Industry (learning resources) Key Results Industry Regulatory
  • 11. New FDA Culture • FSMA implementation is occurring just as FDA culture is changing • FDA is rapidly becoming: – More inspection-oriented – More enforcement-minded 11
  • 12. Educate Before and While We Regulate • Facilitate industry implementation of modern, preventive practices through: – Commodity and sector-specific guidance – Education, outreach and technical assistance – Regulatory incentives for compliance
  • 13. New FDA Strategies 13 • FDA to develop inspection cadre specially trained in and devoted to food inspections • Closer integration of field inspections and CFSAN/ headquarters experts (in real time) • Distinct types of inspections by staff with different technical expertise • Two-tiered inspections and centralized records review
  • 14. FDA is More Inspection-Oriented • FDA is: – Conducting more domestic inspections (with the states) – More strategic about selecting inspection sites – Posting some 483s on website – Expanding definition of “high risk” – Testing more, especially environmental testing – Increasing oversight of imports, especially ingredients, and conducting foreign on-site inspections – Much more forceful in demanding access to records regardless of current legal authority
  • 15. Enforcement is on the Rise • FDA is more critical and more inclined to identify/find issues • Increase in Warning Letters for food adulteration based on food inspections/GMPs • Increase in court injunctions • Heightened use of Import Alerts • New authorities for mandatory recalls and suspension of registration are now in play • Expanded use of Park Doctrine on the horizon
  • 16. What Does This Mean? • FDA’s expectations are changing • Inspections are changing • Testing has increased • Imported ingredients will face particular scrutiny • Crackdowns will increase in frequency Food companies need to 1) Know their rights 2) Adapt to these changes and be prepared! 16
  • 17. 17 Know Your Rights • The FFDCA and implementing regulations specifically address the records that FDA legally is entitled receive during an inspection – When a general inspection, FDA currently has very limited access to records – Once Bioterrorism is invoked, records access is almost unlimited • FDA must provide written notice that the inspection is under the Bioterrorism statute • FDA can ask (and frequently demands) it has the right to records when no such authority exists • Companies should know their rights and then make informed decisions on whether they will voluntarily release additional information
  • 18. What does this mean for your next inspection? • Inspections have already changed: – FDA is energized and persistent and will note all possible violations as inspectional observations – FDA will demand access to records the agency lacks the legal authority to access – FDA will try hard to take photographs even without express legal authority – Inspections involve comprehensive environmental sampling (“swab-a- thon”) Note: Some states have additional legal authorities (e.g., records access), so know your local rules 18
  • 19. 19 Inspectional Observations • 483 Inspectional Observations – A few years ago, investigators would note minor observations orally but would not record them – Today, minor observations are included in the Form 483 – Unusual for a company to escape an inspection without receiving a 483 • FDA policy announced in August 2009 gives industry 15 business days to provide a response • Absolutely essential to respond, in writing, to every 483 observation within the 15 period
  • 20. Implications of FSMA for Inspections New FDA culture + New records access authority + New tools = New inspection paradigm (Starting September 2016) 20
  • 21. FSMA: Systems-Based Approach • Historically, FDA has inspected food facilities for basic sanitation and to detect visible problems with the facility or the product produced – FDA has assessed compliance based on this “snapshot” of the facility’s operations • FSMA requires FDA to take a risk-based approach to facility inspections – Shift from reaction to prevention 21
  • 22. Systems-Based Approach • To implement FSMA’s risk-based inspection mandate, FDA will focus on whether facilities are implementing the systems needed to make safe food • The “systems-based” approach is aimed at preventing problems on a continuing basis, not just when the inspector is in the facility 22
  • 23. “Culture of Food Safety” • FDA provided flexibility in the regulations in exchange for facilities developing a “culture of food safety” • FDA wants to assess whether a company has a “culture of food safety” as a barometer of competence • How can you demonstrate a culture of food safety? – Employees understand their responsibilities and why – You can explain your programs, the rationale behind decisions – With flexibility comes responsibility 23
  • 24. Increased Records Access Authority • FSMA provides FDA with greatly expanded access to records during routine inspections • This new authority facilitates the systems-based inspection approach – Let’s FDA know how a company is operating when inspectors aren’t present – FDA will know what happened not just today, but last week, last month, and last year! • Records review will be a central component of FDA inspections – Inspections will become more like an IRS audit 24
  • 25. Implications of Records Access 25 • Companies decisions will be become much more exposed to scrutiny by inspectors – Flexibility in FSMA proposed rules is double edged sword: with it comes responsibility • If it isn’t documented, it didn’t happen! – “You are what your records say you are”
  • 26. What to Do NOW: • Know your rights • Start preparing for FSMA inspections – Update your inspection manual – Recordkeeping training -- apply good record keeping practices – Review audits for areas of improvement 26
  • 27. • Web site: http://www.fda.gov/fsma • Subscription feature available • Send questions to FSMA@fda.hhs.gov For More Information 27
  • 29. HACCP and HARPC Comparison 29 HACCP HARPC Hazard Analysis Critical Control Point Hazard Analysis Risk-Based Preventive Controls Global standard U.S. standard incorporated into Food Safety Modernization Act (FSMA) Applies to low-acid, canned food, juice, & seafood processors Applies to almost all food processing facilities Traditional HACCP plan based on 7 principles of HACCP Food Safety Plan – A Qualified Individual Must Prepare and Implement a Written Food Safety Plan (117.126(a))
  • 30. HARPC Written Plan Requirements - 117.126(b) 30 Food Safety Plan Hazard Analysis Preventive Controls Supplier Program Recall Program Monitoring Procedures Corrective Action Procedures Verification Procedures
  • 31. 5 HARPC Mandates 31 • Hazard Analysis 117.130 • Preventive Controls 117.135 • Preventive Control Management Components 117.140 • Food Safety Plan Reanalysis 117.170 • Implementation Records Required 117.190
  • 32. Hazard Analysis 117.130 32 • Identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held to determine whether there are significant hazards • Hazard Identification (1) – Biological – Pathogens, Environmental Pathogens, Parasites – Chemical – Radiological, Pesticides and Drug Residues, Natural Toxins, Decomposition, Unapproved Food or Color Additives and Food Allergens – Physical – Physical foreign materials • Hazard Identification (2) (i) Hazards that occur naturally (ii) Hazards that may be unintentionally introduced (iii) Hazards that may be intentionally introduced for economic gain • Hazard Evaluation (2c) (i) Hazards must be evaluated to assess severity of illness/injury and probability the hazard will occur (ii) Environmental pathogens whenever a RTE food is exposed prior to packaging
  • 33. Hazard Analysis 117.30 33 Formulation of the food Condition, function and design of the facility and equipment Raw materials and ingredients Transportation Practices Manufacturing / Processing Procedures Packaging and Labeling Activities Storage and Distribution Intended or Reasonably Foreseeable Use Sanitation and Employee Hygiene Other Relevant Factors Hazard evaluation must consider the effect of the following:
  • 34. Preventive Controls 117.135 34 Process Controls Food Allergen Controls Sanitation Controls Supplier Controls Recall Plan Other Controls • Controls established at Critical Control Points (CCPs), if they have been identified • Controls are also appropriate at non-CCPs Control parameters and values for processes such as heat, refrigeration, acidifying, irradiating etc. Protection and labeling Sanitary condition for pathogen and allergen control Risk based for significant hazard ingredient For food with a significant hazard Hygiene Training; GMP’s
  • 35. Preventive Control Management Components 117.140 35 Validation Verification of Monitoring Verification of Corrective Actions Verification of Implementation and Effectiveness Reanalysis Monitoring: written procedures with adequate frequency documented on records Corrective Action and Corrections: For pathogens, environmental pathogens and unanticipated food safety problem Scientific or technical information prior to implementation or during first six weeks of production Conducted as required As required Calibration, product testing, environmental monitoring, and record reviews 3 years, changes, unanticipated events, FDA determination
  • 36. Food Safety Plan Reanalysis 117.170 36 • Performed before change is operative or during first 6 weeks of production when necessary • Revise the Food Safety Plan if a significant change made or document basis for no revisions • Performed by a qualified individual • FDA determines it is necessary to respond to new hazards or developments Reanalysis Once every 3 years Significant change made Aware of new info Unanticipated food safety issue Preventative control found ineffective
  • 37. Implementation Records Required 117.190 37 • Food Safety Plan • Preventive Control Monitoring Records • Corrective Action Records • Verification Records 1. Validation records 5. Product Testing 2. Monitoring verification 6. Environmental Monitoring 3. Corrective Action verification 7. Records Review 4. Calibration records 8. Reanalysis records • Training Records for Qualified Individuals who have had HACCP/HARPC training certification
  • 38. HACCP to HARPC Reassessments – Major Changes 38 • Creation of Food Safety Plan with all required components • Reassessment of the Hazard Analysis for: - Risk and severity evaluation of hazards - Inclusion of radiological hazards - Inclusion of unintentionally introduced hazards - Inclusion of intentionally introduced hazards for economic gain • Identification of Preventive Controls and control measures • Verification of Implementation Effectiveness Procedures – product testing and environmental testing requirements • Training requirement to be considered a qualified individual
  • 40. FDA Resources 40 • Web site: http://www.fda.gov/fsma • FSMA Proposed Rule at a Glance – http://www.fda.gov/downloads/Food/GuidanceRegulation/FSM A/UCM412922.pdf • Food Safety Modernization Act – http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.ht m • FSMA Proposed Rule for Preventative Controls for Human Food Detail – http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm3341 15.htm
  • 41. AFFI Resources 41 • FSMA Readiness Self Assessment Checklist • Useful Industry Resource Available • Available for purchase at www.affi.org • http://www.affi.org/member-services/fsma-self-assessment- tool • AFFI Forum – October 19-22, 2015 Lake Geneva, WI • AFFI Regulatory and Technical Support Assistance
  • 42. Alchemy Professional Services Offerings 42 Training HARPC Workshop based on FDA recognized standardized curriculum • Public courses or on-site • On-line courses coming soon Gap Analysis • On site review to evaluate existing programs, products and facility to new regulatory requirements • Off site desk top review of existing HACCP Plans comparison to new regulatory requirements Development Creation of new Food Safety Plan documentation customized for your products and processes Reanalysis • Desk top review of client created Food Safety Plan • On Site Reanalysis to validate food safety system and written program compliance
  • 44. Upcoming Events 44 • Network with industry leaders • Master best practices • Discover new technologies http://www.alchemysystems.com/alchemy-conference/
  • 45. Thank you! Dr. Donna Garren – dgarren@affi.com – 703.821.0770 Jeff Chilton – jeff.chilton@alchemysystems.com – 706.483.4400 contactus@alchemysystems.com www.alchemysystems.com/solutions/professional-services The Feed: Alchemy Blog