HACCP and HARPC: Distinguishing Between Apples and Oranges

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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!