FSMA and HACCP - EventRebels 117 –CMP, HARPC AND RBPC HARPC Development Requirements •Must be written regardless of outcome •Must be based on experience, illness data (recalls),

FSMA ReadinessJesse Leal, AIB International

PART 117 – CMP, HARPC AND RBPC

Foodborne Illness in the US

• According to the 2011 CDC report, Estimates of Foodborne Illness in the United States, each year:

– Roughly 1 in 6 Americans (or 48 million people) get sick

– 128,000 are hospitalized

– 3,000 die of foodborne diseases

• Direct effects:

– Economic impact: billions of dollars lost

– FDA is pursuing criminal action in some cases


Recalls by the Numbers, continued

Source: 4th Annual Reportable Foods Registry (2013)


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


Are You Ready for the “New” FDA Inspection?• Do you know your rights and obligations?

• Do you have clear written company policies regarding official inspections?

• When will you update the inspection manual?

• Are personnel dedicated to FDA inspections trained?

• Do you have other knowledgeable personnel?


5 Key Elements of FSMA

FSMA

Prevention

Inspection and

Compliance

ResponseImports

Enhanced Relationships


How Good are Your Records?

• What are your record preparation and keeping practices?

• Do your records reflect the real conditions under which the product was manufactured?

• Are they audit proof?


Automatic Access to Records

• What “automatic access” means:

– Records in plain sight

• Including those kept electronically

– Records of interstate/international commerce

• Shipping and receiving

• Traceability


Situational Access to Records

• What “situational access” means:

– Under FSMA, the FDA can now access any of a facility’s records related to the manufacturing of a product, and copy them when it has “reason to believe” an article of food:

• Is/could be adulterated

• Is/could misbranded

• Suspected of being able to cause SAHCODHA

– Records must be made available within 24 hours


Inspections, continued

• Enforcement oriented

– More minor findings being listed on Form 483

– Increased use of warning letters

– Actions for injunction

– Park Doctrine and criminal liability


Inspection Results

• Inspection results between 10/1/12 – 9/30/13

– Number of food F483s issued = 2386 (47%)

• Top six issues (56% of the 2386 issued)

1. Lack of effective pest exclusion

2. Sanitation monitoring

• Failure to maintain hand washing, hand sanitizing, and toilet facilities

• Failure to protect food, food packaging material, and food contact surfaces from adulteration


RFR, continued

• The RFR:

– Requires a responsible party to file a report through the RFR electronic portal when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals (SAHCODHA)


Educate, Educate, Educate

• What is your time table for continuous education of all personnel on FSMA?

– The basics

– What’s new under FSMA

• Qualified Individuals

– The expectations


Emphasis for Revision

• Records Maintenance and Access

–Records required to be maintained and available for inspection

• Employee training records

• Allergen control plans

• Environmental pathogen control plans

• Sanitation procedures


Emphasis for Revision

• Written Sanitation Procedures

–Develop written procedures for all food contact equipment and surfaces

• Define scope

• Objective

• Management responsibility

• Monitoring

• Corrective action and record keeping


FDA Regulation

• Part 110.40, Equipment and Utensils

– Equipment - Clean Design

– Installed for Cleanability

– Installed to Prevent Contamination

–Closed Systems Maintained

– Freezer and Cooler Thermometers

–Production Instrumentation Accurate

–Compressed Gas / Air Filtered


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


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?


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


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


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


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


The 12 Categories of Hazards Under HARPC

BiologicalParasites

ChemicalNatural Toxins PesticidesDrug Residue AllergensDecomposition Unapproved Additives

Physical

Hazards not covered under HACCP

• Radiological• Intentional: EMA


Risk-Based Preventive Controls

Potential PCs:Prerequisite Programs

• Sanitation

• Personnel practices

• Chemical control

• Allergen control

• Maintenance

• Water quality

• Environmental monitoring

• Supplier control

• Other

Process Steps:

• Cooking

• Cooling

• Strainers/Sifting

• Metal detection

• Bottle Washing

• Ozone or UV treatment

• Optical scanner

• Irradiation

• Sanitizing

• Other

Specific operational and non-operational activities:

• Temperature

• Change over cleaning

• Calibration

• Rework

• Hand washing

• Rinse water pH

• Pre-op/operational inspection

• Other


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


PC Management Components

Monitoring Procedures

– To ensure Preventive Controls are consistently performed

• What is being controlled

• How is this being done

• When or the frequency of checking

• Who will be responsible for this activity


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)


Managing Preventive Controls

. . .allow flexibility for the application of management elements for preventive controls so that such controls are managed with a level of rigor commensurate to the nature of the risk and the type of control employed..

“Levels of oversight should align with the risk and type of Preventive Control”


Role Environmental Monitoring

• Verifies PCs are preventing unsanitary condition(s)

– Roof leaks, standing water, condensate, pathogen harborage in building structure (floors, walls) or equipment, utensils & equipment (contact & noncontact), cleaning not effective, unsanitary plant conditions, etc.

• Done “as appropriate” for RTE foods

• The goal is to know where problems are and correct them = find root causes and eliminate them


Role of Product Testing

• “Product” means ingredients, in-process and finished product

• Seen as a verification activity

– Verifies consistency and effectiveness of preventive control(s)

– Applicable to Ready to Eat (RTE) products

• Done “as appropriate” for type of food

– Kill step, allergen cleaning, cross contact, supplier verification, etc.

• Requires procedures, corrective actions and recordkeeping if used


Go Back to the Basics

• Assess facility and assure that the following are in place applied consistently, part of the culture:

– Sanitation

– Allergen control and

– GMP compliance

• Assess effectiveness of “corrective action”

– Assure root cause elimination and not just treating the symptoms

• Get a “fresh” outside look at your facility


Assess Your FSMA Readiness

• Do you have the key elements in place, and how robust are they?

• Preventive controls

– Process PCs

– Sanitation PCs

– Allergen PCs

– Supply chain control

– Others as defined by the Hazard Analysis (glass jars, etc.)


Integrating HARPC and HACCP

HARPC

– Similar concepts to HACCP!

– Somewhat different from HACCP!

– Include in HACCP, subset or separate?

– What to do?


HARPC = or ≠ HACCP?HACCP HARPC Solutions

International Codex 21 CFR Part 117

HACCP Team and Coordinator

Preventive Control QualifiedIndividual(s)

Flow diagram required and verified on the floor

Not required

Product description, intended use, and technical parameters

Product and technical parameters

3 hazards, B, C, and P 12 hazards + intentional + EMA

Hazard Analysis by team

Hazard Analysis by PCQI with FDA Guidance



Identifies CriticalControl Points (CCPs)

Identifies Risk-Based Preventive Controls (PCs)

Requires critical limits for CCPs

Requires parameters for RBPCs, as appropriate

CCPs must bevalidated

Validation of RBPCs, as appropriate

Requires verification / validation

As appropriate, verification / validation

CCP corrective action: reprocess, animal food or destroy

RBPC corrective actionallows for product evaluation



Specificdocumented monitoring and corrective action

Documented monitoring with flexibility

Reassess whenchanges occur and yearly validation

Reassess when changes occur and every three years

Does not require check on supplier regulatory compliance

If supplier controls used, must include verification activities, including regulatorycompliance history

Finished product testing not required for validated kill steps

As appropriate,product testing e.g. (RTE)


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

What’s Next?

Until November 2016 to come into compliance.Set up a transition team

Obtain, study and understand the final rule.Obtain, study and apply applicable guidance

documents.Undertake the hazard evaluation.

Who will control the hazards needing a PCWhat will be the PCs

Develop the written Food Safety Plan.Integrate HACCP and HARPC? – options.

Make sure you engender Qualified Individuals.

Documents

FSMA and HACCP - EventRebels 117 –CMP, HARPC AND RBPC HARPC Development Requirements •Must be written regardless of outcome •Must be based on experience, illness data (recalls),