Building a FSMA Compliant

Food Safety Plan

Lilia M. Santiago-Connolly, Ph.D.

H.J. Heinz

Outline

• Requirements for FSMA compliant Food Safety

Plans (HACCP?)

• Hazard analysis

• Preventive controls

• Monitoring

• Corrective actions

• Verification

• Summary

Why FSMA is needed?

• Foodborne illness & Recalls

• Consumer Demands

• New food vehicles

• Growing population

• Imported Food- 15% for US

• New hazards

1. Preventive Controls

2. Inspection & Compliance

3. Response (recall plan)

4. Imported Food Safety

5. Enhanced Partnerships

FSMA Part 117 Subpart C

• “Owner, operator or agent in charge of facility

prepare (or have prepared) and implement a

written food safety plan”

• Food Safety Plan must have: • Written hazard analysis

• Written preventive controls

• Monitoring procedures

• Corrective actions procedures

• Verification Procedures

• A recall plan

Written Hazard Analysis

• First Step: Ingredient Risk Assessment

• List of all active ingredients, packaging materials,

finished products

• Storage conditions: frozen, ambient, refrigerated

• Food Category/Classifications: Meat (raw, cooked,

processed), Dairy (natural, fermented)

• Allergens

• Food safety hazards must be specific: Microbiological,

Chemical, Physical, Radiological

Foods Safety Hazards Risk Assessment

• Likelihood of occurrence depends on:

• Recent recalls related to particular food

• Sources of contamination

• Trends in Foodborne illness

• Consumer complaints

• Factory environment

• Wet vs. Dry

• Preventive maintenance

• Historical data

• Industry data

• Ability of food to support growth (microbiological)

• GRAS (chemical)- safe for the particular use and food

Food Safety Hazards

Microbiological Chemical Physical Radiological

Salmonella Pesticides Metal Radionuclides

Listeria monocytogenes Heavy Metals Wood

E. coli O157:H7 Mycotoxins Glass

Staphylococcus aureus Food Allergens Plastic

Bacillus cereus Pyrrolizidine alkaloids Paper

Campylobacter jejuni Hormones

Clostridium perfringens Antibotics

Clostridium botulinum phytohaemagglutinin

(especially kidney beans)

Norovirus Mushroom toxins

Cyclospora cayetanesis

(berries)

Patulin (apple, pear, grape)

Hepatitis A Environmental

contaminants (seafood)

Trichinella Dioxin and dioxin-like

PCBs

Shigella Acrylamide (only if fried or

roasted)

Refrigerated Dough - raw Salmonella None None None

Ambient Dairy - Cheese sauces - aseptic None None None None

Ambient Dairy - dried Salmonella None None None

Ambient Dairy - others Salmonella, Listeria monocytogenes, Staphylococcus aureus None None None

Ambient Margarine - non dairy None None None None

Ambient Egg - spray dried Salmonella None None None

Ambient Egg - non spray dried Salmonella, Staphylococcus aureus None None None

Ambient Spices Salmonella, Clostridium perfringens, Bacillus cereus None None None

Ambient Flour Salmonella, E. coli O157:H7 None None None

Ambient Corn Meal

Salmonella, E. coli O157:H7

None None None

Ambient Rice- Parboiled Salmonella, Clostridium perfringens, Bacillus cereus

None None None

Ambient Bread crumbs

Salmonella, E. coli O157:H7 None

None None

Ambient Batters/Breaders Salmonella, E. coli 0157:H7, Clostridium perfringens, Bacillus

cereus None None

Ambient Starch Clostridium perfringens, Bacillus cereus None None None

Ambient Maltodextrin None None None None

Ambient Pasta Salmonella, Clostridium perfringens None None None

Ambient Nuts, Seeds Salmonella None None None

Ambient Fruits - dried Salmonella None None None

Ambient Raw Potatoes

Salmonella, Listeria monocytogenes, Clostridium botulinum

None Hepatitis A,

Norovirus None

Ambient Vegetables - dried Salmonella, Listeria monocytogenes, Bacillus cereus,

Clostridium perfringens None None None

Ambient Acidified Vegetables None None None

Ambient Herbs - dried Salmonella, Clostridium perfringens, Bacillus cereus None None None

Microbiological Hazards

Storage Food Category Chemical Hazards

Frozen Dairy aflatoxin M1, hormones, pyrrolizidine alkaloids,

antibiotics

Frozen Egg None

Frozen Pork / Lamb / Veal / Mutton hormones, pesticides, antibiotics

Frozen Beef / Beef products hormones, pesticides, antibiotics

Frozen Poultry / Poultry Products pesticides, antibiotics

Frozen Seafood - raw

environmental contaminants (heavy metals,

pesticides, PCB, antibiotics), ciguatoxin, shellfish

toxins, illegal colorants (if imported), aquaculture

d*rugs, food and color additives, histamine, refer to

FDA Guide and Guidance for species-specific

hazards*

Frozen Seafood - cooked, bases (Aw<0.85), highly

processed

environmental contaminants (heavy metals,

pesticides, PCB, antibiotics), ciguatoxin, shellfish

toxins, illegal colorants (if imported), aquaculture

drugs, histamine, refer to FDA Guide and Guidance

for species-specific hazards *

Frozen Pasta heavy metals, aflatoxin, pyrrolizidine alkaloids

Frozen Rice pyrrolizidine alkaloids

Frozen Bread and Dough aflatoxin, pyrrolizidine alkaloids

Frozen Fruits, Vegetables, Herbs heavy metals, pesticides, aflatoxin

Frozen Beans phytohaemagglutinin (especially kidney beans)

Frozen Mushrooms mushroom toxins

Frozen Herbs heavy metals, pesticides, aflatoxin

Frozen Fruits heavy metals, pesticides, aflatoxin

Chemical Hazards

Written Hazard Analysis

• What factors to consider when conducting the hazard

analysis?

• Incoming materials

• Process steps

• Equipment

• Factory environment

• Intended use

• Factory history

• Industry data/recalls

Example of Hazard Analysis

Step # Process Step

Potential hazards introduced,

controlled, or enhanced at this

step

Severity of

Hazard

(High,

Medium,

Low)

Likelihood of

Occurrence

(High,

Medium, Low)

Risk Factor

(per Table 1 of

QSP 1.03.04)

Does the

potential

hazard need

to be

addressed in

HACCP

plan?

Justification for

decision made in the

previous column

What measures

can be applied to

prevent, eliminate,

or reduce the

hazard(s) being

addressed in your

HACCP plan?

Is this a

Critical

Control Point

(CCP)?

Biological:

Chemical:

Physical:

How to verify the food safety plan is

working?

• HACCP/Food Safety Plan Assessment

• Management support (i.e. HACCP/FS team)

• Execution on written plan on the factory floor

(adherence & performance)

• Review of historical records and corrective actions

What you could find wrong with your

food safety plan?

• Missing process steps

• Missing equipment

• Missing correct hazards

• Poor or no justifications

• Generic names for pre-requisite programs

• Missing ingredients

• Hazards analysis and flow chart do not match

• Formulation has changed

• New products not added to plan

FSMA Proposed Rule

Preventive Controls definition 2013

• Preventive controls means those risk-based,

reasonably appropriate procedures, practices, and

processes that a person knowledgeable about the

safe manufacturing, processing, packing, or holding

of food would employ to significantly minimize or

prevent the hazards identified under the hazard

analysis that are consistent with the current scientific

understanding of safe food manufacturing,

processing, packing, or holding at the time of

analysis.

Why written preventive controls?

• To support established verification activities and validation

procedures in a food safety plan (verification)

• To help monitor procedures and verify adherence that these

are working effectively (monitoring)

• To ensure corrective actions are properly taken (corrective

actions)

• To provide right documentation

• To provide assurance that hazards are not reasonable to

occur, and that the hazard will be minimized or prevented

(justifications)

Written Preventive Controls • Programs are based on risk

• Risk assessments on ingredients, packaging, finished goods,

environment

• Appropriate procedures, practices and processes

• Sanitation procedures

• Employee hygiene practices

• Environmental monitoring

• Food Allergen Control

• Identification of Non-conforming

• Recall plan

• GMPs

• Supplier verification

• Incoming materials & finished good testing

Preventive Controls Checklist Statu

s

R/Y/G

PREVENTIVE CONTROLS Corporate Policy Factory Policy Blank Record

Forms Validation

HACCP/Food Safety Plan

Monitoring Records for Food

Safety

Nonconformance Records to

Food Safety Incidents

Food Safety Incident

Investigations

Corrective Actions to

Nonconformance’s

Food Allergens Control

Sanitation

GMPs

Environmental Testing Listeria

Environmental Testing

Salmonella

Environmental Testing Indicator

Organisms

Finished Product Testing

Validation Cooking/Baking

Validation Cooling/Freezing

Challenge Studies

Shelf Life Studies

Scientific Literature (HACCP &

Validations)

Supplier Verification Records

Recall Plan

Records of Recalls / Traceability

Exercises

Food Defense Plan

Monitoring

• Monitoring of Preventive Controls

• Written

• Consistently performed (adherence)

• Well established

• Maintained as written on the procedures

Corrective actions

• Facilities are required to establish and implement written corrective actions

procedures that would be used if preventive controls are not properly

implemented.

• Examples:

• Chemical including allergen contamination

• Physical (all foreign materials contamination)

• Environmental pathogen monitoring

• Finished Product Microbiological testing

• HACCP CCP failure

• Pest Control

• Mislabeling

• Rework

• Sanitation (Pre-op/Operational)

• GMPs failures

Recall Plan

• Mandatory recall authority

• Expanded administrative detention

• Suspension of registration

Verification:

FSMA Proposed Rule 2013

Definition

“Verification means those activities, other than

monitoring, that establish the validity of the food

safety plan and that the system is operating

according to the plan.”

Verification of Food Safety Plan

• Verification activities include as per 2013

proposed FSMA rule:

• Validation of preventive controls

• Verification that monitoring is being conducted

• Verification that appropriate decisions about

corrective actions are consistently implemented and

to minimize or prevent identified food safety hazards

Verification Activities

• Adherence monitoring and direct observations

• Food Safety Plan-CCP’s

• Preventive Controls

• Calibration of process instruments

• Thermometers, metal detectors, pH meters, RTD’s

• Review of Corrective Actions

• Consistent, sound decision making

• Performance Verification

• Training adherence

• Records compliance

Summary

Where to focus when building a robust food safety plan?

• Focus on specific food safety hazards

• Risk based assessment

• Ensure preventive controls are under an adherence program

• Corrective actions are taken as written

• Verification activities will give validity and determine compliance

of the food safety plan