FDA's current deadline for publishing the final rules for preventative controls for is quickly approaching. Find out what your company needs to know to prepare for these new regulatory requirements for FDA-regulated processors. This presentation provides an overview of preventative controls requirements under the Food Safety Modernization Act (FSMA), what is HARPC, and how to make the HACCP to HARPC conversion, as well as reassessing food safety plans for compliance and effectiveness.
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
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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
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