HACCP and HARPC: Distinguishing Between Apples and Oranges
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Transcript of HACCP and HARPC: Distinguishing Between Apples and Oranges
©Copyright AIB International
May not be reproduced without written permission.
Serving the Food Industry Since 1919
HACCP and HARPC:
Distinguishing Between
Apples and Oranges
Presented By:
Stephanie Lopez
Vice President, Food Safety Innovation
AIB International
HACCP and HARPC
Food Safety Modernization Act
• January 4, 2011
• Facilities/products under FDA jurisdiction
• Preventive controls (HACCP-like)
Rule-Making Process Bill is Passed by House and
Senate
The Act is Enforceable by
the FDA
President Signs the Act
Proposed Rules are Written to Further
Describe Some Requirements
Proposed Rules are Published and
Comment is Sought
Final Rules are Published Including
Compliance Dates
Final Rules are Enforced by FDA
34 Sections of FSMA
fall here
7 Sections of FSMA
fall here
Seven Sections of FSMA that Require Rule-Making
• Section 103 – Preventive Controls
• Section 105 – Produce Safety
• Section 111 – Sanitary Transport of Food
• Section 301- Foreign Supplier Verification
• Section 302 – Voluntary Qualified Importer Program
• Section 303 – Import Certificates
• Section 307 – Accreditation of Third Party Auditors
Rule-Making Process
Section 103 – Preventive Controls Rules
1.Preventive Controls for Human Food
2.Preventive Controls for Animal Food
3.Mitigation Strategies to Protect Food from
Intentional Adulteration
Rule-Making Process
- Not HARPC
HACCP and HARPC
HARPC
• Hazard Analysis and Risk-Based
Preventive Controls
• “Preventive Controls”
• Proposed Rule for Human Food – Comment Period: Jan 2013 to Nov 2013
• Proposed Rule for Animal Food – Comment Period: Oct 2013 –Feb 2014
HACCP and HARPC
HARPC:
• Written Analysis of Hazards
• Identification of Preventive Controls
• Monitoring of Preventive Controls
• Corrective Actions for Ineffective or
Absent Preventive Controls
• Verification of Preventive Controls
• Preventive Control Records
HACCP and HARPC
HARPC
• Similar concepts to HACCP
• Markedly different from HACCP
Global Standard
(Codex Alimentarius)
USDA: Meat and
Poultry
FDA: Seafood and
Juice
HACCP HARPC
US Standard
Limited FDA products
Preliminary Tasks
• Assemble a team
• Describe product
• Identify intended use
• Construct flow diagram
• Verify flow diagram
HACCP HARPC
No Preliminary Tasks
Does not Require a
Qualified Individual
(Does require a team)
HACCP HARPC
Requires a Qualified
Individual
• Prepare the Plan
• Validate controls
• Review records
• Conduct re-analysis
Qualified by
• Training
• Experience
HAZARDS
• Biological
• Chemical
• Physical
HACCP HARPC
HAZARDS
• Biological
• Chemical
• Physical
• Radiological
Hazard Analysis is
largely done for
industry
Seafood Hazards and
Controls Guide
Juice HACCP Hazards
and Controls Guide
HACCP HARPC
Hazard research will
need to be performed
and documented by
each facility
Identification of Critical
Control Points
Does not recognize
“Preventive Controls”
HACCP HARPC
Identification of
Preventive Controls
Does not distinguish
CCP’s from other
controls
Critical Control Points
A step at which control
can be applied and is
essential to prevent or
eliminate a food safety
hazard or reduce it to an
acceptable level
HACCP HARPC
Preventive Controls
Reasonably appropriate
procedures, practices,
and processes that a
person knowledgeable
about the safe of food
would employ to
significantly minimize or
prevent hazards
SSOP’s (Juice/ Seafood)
1. Safety of water
2. Condition and cleanliness of
food contact surfaces
3. Prevention of cross-
contamination
4. Maintenance of hand washing
and toilet facilities
5. Protection from adulteration
6. Proper handling of toxic
compounds
7. Control of employee health
8. Exclusion of pests
HACCP HARPC
Preventive Controls
Proposed
• Sanitation controls
• Allergen controls
• Recall plan
• Process controls
Pending
• Hygiene training
• Environmental monitoring
• Some GMP’s
• Supplier Verification
CCP’s
+
SSOP’s
HACCP HARPC
Preventive Controls
Includes Critical Limits
Criterion that
separates acceptability
from unacceptability
HACCP HARPC
Does not require
Critical Limits for all
controls
Some preventive
controls may not have
specific parameters
associated with them
Monitoring:
Checking the CCP to
determine if Critical
Limit has been met
HACCP HARPC
Monitoring:
Checking the
Preventive Control to
determine if it was
effective
Some controls have
parameters and some
don’t
Verification:
The application of
methods, procedures,
tests and other
evaluations, in addition
to monitoring to
determine compliance
with the HACCP plan
HACCP HARPC
Verification:
Those activities other
than monitoring that
establish the validity of
the food safety plan
and that the system is
operating according to
the Plan.
Validation:
Obtaining evidence that
the elements of the
HACCP Plan are
effective
HACCP HARPC
Validation:
Element of verification
focused on collecting
and evaluating scientific
and technical
information to determine
whether the food safety
plan will effectively
control the identified
hazards.
Validation Scope
All elements
HACCP HARPC
Validation Scope
Validation does not need
to address:
•Food allergen controls
•Sanitation controls
•Recall plan
Corrective Action:
Affected food is
discarded or
re-processed through
a functioning CCP.
HACCP HARPC
Corrective Action:
Affected food is
evaluated.
Re-Analysis:
When there are
significant changes
Not to exceed 1 year
HACCP HARPC
Re-Analysis:
When there are
significant changes
Not to exceed 3 years
Availability to FDA
Seafood/ Juice –
During onsite
inspection
HACCP HARPC
Availability to FDA
During onsite
inspection
Send into FDA in
advance?
Record Retention
1 year for perishable
items
2 years or the shelf-life
of the product,
whichever is greater
HACCP HARPC
Record Retention
2 Year Retention
HACCP and HARPC
Next Steps…
DO NOT MAKE ANY
CHANGES TO YOUR
HACCP PLAN!
HACCP and HARPC
Next Steps
Qualified Individual
• Get HACCP Training as
foundation
• Food Safety Preventive
Controls Alliance – HARPC
Curriculum
HACCP and HARPC
Next Steps
Radiological Hazards
• Obtain supporting
documentation about
whether your water
supply is at risk
HACCP and HARPC
Next Steps
Radiological Hazards
• Expand crisis
management plan to
include radiological
events
HACCP and HARPC
Next Steps
Hazard Analysis
• Obtain supporting
evidence of hazards
that are RLTO
HACCP and HARPC
Next Steps
Process Controls
• Validate Process Controls
(CCP’s and others)
• Scientific / technical information • Exact same parameters
or
• Custom Studies
HACCP and HARPC
Next Steps
Record keeping
• Training and follow-up on
good recordkeeping
practices
HACCP and HARPC
Next Steps
Vulnerability Assessment
• Conduct a documented
vulnerability assessment
• Mitigation of Intentional
Adulteration
Radiological Hazards and
Controls
Hazard Research
Vulnerability Assessment
Validation of Process Controls
HACCP
HACCP and HARPC
HACCP and HARPC
HACCP is the foundation
Make preparations now for HARPC
• Training
• Records
• Validation
Watch what unfolds for specific
implementation cues and timelines
HACCP and HARPC
Thank You!
Questions?
Happy 100th Anniversary
NWFPA!