HACCP vs.
HARPC
Jesse Leal, AIB International
PART 117 – CMP, HARPC AND RBPC
Intent, Scope and Implications of HARPC
• From correction to prevention
– Reducing the number of failures
• Back to the basics
– 402 (a) (4) from 402 (a) (3)
• Food Safety from “Farm to Fork”
– Supply chain applied control
• Global
– Food imports
• Responsibility and accountability
– Private sector
PART 117 – CMP, HARPC AND RBPC
Recalls by the Numbers
• Recalled products typically numbered in the hundreds in
the past decade
• By 2009, thousands of products were being recalled
annually
• Possible reasons?
– Increased imports
– Growing complexity of the supply chain
– Better detection and recognition of food safety
problems
– Better reporting by manufacturers, i.e., RFR
PART 117 – CMP, HARPC AND RBPC
Recalls by the Numbers, continued
Source: 4th Annual Reportable Foods Registry (2013)
PART 117 – CMP, HARPC AND RBPC
Preventive Controls Qualified
Individual
• FDA‐recognized training
– FSPCA (Food Safety Preventive Controls Alliance)
– Train lead instructor(s) to subsequently train
employees
– Or otherwise qualified (training/experience)
Annex A, Page 8
PART 117 – CMP, HARPC AND RBPC
Preventive Controls Qualified
Individual
To do or oversee:
– Preparation of a Food Safety Plan
– Validation of Preventive Controls
– Review of records for implementation and
effectiveness of
– Preventive Controls
– Appropriateness of corrective actions
– Reanalysis of Food Safety Plan
– FDA will assess qualified individuals (real plant
conditions vs. records)
– What will you present to the FDA?
PART 117 – CMP, HARPC AND RBPC
Your Food Safety Plan
Must include:
– Hazard analysis methodology & results
– Identification of preventive controls
– Supply chain program as required
– Recall plan
– Monitoring, corrective action, and verification
procedures
– Validation
Annex A, page 30
PART 117 – CMP, HARPC AND RBPC
Your Food Safety Plan
• “Written” means
– Food Safety Plan
– Procedures & records
• Must be prepared or overseen by one or more
Preventive Controls Qualified Individuals (PCQI)
• The owner, operator, or agent in charge of the
facility must sign and date the food safety plan:
– Upon initial completion and
– Upon any modification
Annex A, page 30 & 54
PART 117 – CMP, HARPC AND RBPC
HARPC Development Requirements
• Must be written regardless of outcome
• Must be based on experience, illness data (recalls),
scientific papers, including guidance documents and other
information
• Must include raw materials/ingredients, process and
environment
• Must consider specific factors cited in the rule
• Must identify “known or foreseeable hazards”
– Includes B, C, P, radiological and EMA
• Must complete a risk analysis to identify who will control
the hazard and the appropriate control
PART 117 – CMP, HARPC AND RBPC
The 12 Categories of Hazards
Under HARPC
What are they?
1. Biological 7. Drug Residues
2. Chemical 8. Decomposition
3. Physical 9. Parasites
4. Radiological 10. Allergens (Human Food
only)
5. Natural Toxins 11. Unapproved Additives
6. Pesticides 12. Intentional
Answer
PART 117 – CMP, HARPC AND RBPC
The 12 Categories of Hazards
Under HARPC
Biological
Parasites
Hazards not covered
under HACCP
Chemical • Radiological
Natural Toxins Pesticides • Intentional: EMA
Drug Residue Allergens
Decomposition Unapproved
Additives
Physical
PART 117 – CMP, HARPC AND RBPC
Risk-Based Preventive Controls
Potential PCs:
Prerequisite Programs Specific operational and Process Steps:
non-operational
• Sanitation • Cooking
activities:
• Personnel practices • Temperature
• Cooling
• Chemical control • Change over cleaning • Strainers/Sifting
• Allergen control • Calibration • Metal detection
• Maintenance • Rework • Bottle Washing
• Water quality • Hand washing • Ozone or UV
• Environmental • Rinse water pH treatment
monitoring • Pre-op/operational • Optical scanner
inspection • Irradiation
• Supplier control
• Other
• Other • Sanitizing
• Other
PART 117 – CMP, HARPC AND RBPC
Environmental Risk Assessment
The hazard evaluation must include an assessment
– of environmental pathogens whenever a
ready‐to‐eat (RTE) food is exposed to the
environment prior to packaging and the
packaged food does not receive a pathogen
reduction treatment.
– or otherwise includes a control measure (such
as a formulation lethal to the pathogen) that
would significantly minimize the pathogen.
Annex A, Page 4
PART 117 – CMP, HARPC AND RBPC
PC Management Components
– Monitoring
– Corrections and corrective action
– Verification
– Validation
– Supply chain program
– Record review for all the above
– Reanalysis of Food Safety Plan
– Recall plan
Annex A, Page 35
PART 117 – CMP, HARPC AND RBPC
PC Management Components
Corrective action procedures must describe the
steps to be taken to insure that:
• The PC violation is identified, recorded and
corrected
• Reduce the likelihood that the problem will
recur
• All affected food is evaluated for safety and
• Affected food is prevented from entering
commerce if you cannot ensure that the food
is not adulterated or misbranded (labeling)
PART 117 – CMP, HARPC AND RBPC
PC Management Components
Verification Procedures
– Monitoring is being implemented as written
– Appropriate decisions about corrective actions are
being made
– Hazards are effectively minimized or prevented
– Calibration
– Product testing for pathogen or other hazard
– Environmental monitoring
– Review of records
PART 117 – CMP, HARPC AND RBPC
PC Management Components
Validation
– For PCs as appropriate by PCQI
– Prior to implementation of Food Safety Plan, or
– Implemented 90 days after production begins
– Don’t need to validate:
• Food allergen controls
• Sanitation controls
• Recall plan
• Supply chain program
• Other PC if written justification in provided
Annex A, Page 39
PART 117 – CMP, HARPC AND RBPC
Integrating HARPC and HACCP
HARPC
– Similar concepts to HACCP!
– Somewhat different from HACCP!
– Include in HACCP, subset or separate?
– What to do?
PART 117 – CMP, HARPC AND RBPC
HARPC = or ≠ HACCP?
HACCP HARPC Solutions
International Codex 21 CFR Part 117
HACCP Team and Preventive Control
Coordinator Qualified
Individual(s)
Flow diagram Not required
required and verified
on the floor
Product description, Product and
intended use, and technical parameters
technical parameters
3 hazards, B, C, and P 12 hazards +
intentional + EMA
Hazard Analysis by Hazard Analysis by
team PCQI with FDA
Guidance
PART 117 – CMP, HARPC AND RBPC
HARPC = or ≠ HACCP?
HACCP HARPC Solutions
Identifies Critical Identifies Risk-Based
Control Points (CCPs) Preventive Controls
(PCs)
Requires critical limits Requires parameters
for CCPs for RBPCs, as
appropriate
CCPs must be Validation of RBPCs, as
validated appropriate
Requires verification / As appropriate,
validation verification / validation
CCP corrective action: RBPC corrective action
reprocess, animal food allows for product
or destroy evaluation
PART 117 – CMP, HARPC AND RBPC
HARPC = or ≠ HACCP?
HACCP HARPC Solutions
Specific Documented
documented monitoring with
monitoring and flexibility
corrective action
Reassess when Reassess when
changes occur and changes occur and
yearly validation every three years
Does not require If supplier controls
check on supplier used, must include
regulatory verification activities,
compliance including regulatory
compliance history
Finished product As appropriate,
testing not required product testing e.g.
for validated kill (RTE)
steps
PART 117 – CMP, HARPC AND RBPC
Your Options
• FDA does not require a HACCP Program
– Except seafood, juice
• It is an OPTION to eliminate your HACCP Program,
however:
• Reasons to retain a HACCP Program:
– Recognized/required by domestic and foreign
customers
– AIB requirement
– GFSI requirement (BRC, SQF, IFS, FSSC 22000)
– Retain emphasis on food safety culture
