Building a FSMA Compliant Food Safety Plan. Lilia M. Santiago-Connolly, Ph.D. H.J. Heinz

Transcription

1 Building a FSMA Compliant Food Safety Plan Lilia M. Santiago-Connolly, Ph.D. H.J. Heinz

2 Outline Requirements for FSMA compliant Food Safety Plans (HACCP?) Hazard analysis Preventive controls Monitoring Corrective actions Verification Summary

3 Why FSMA is needed? Foodborne illness & Recalls Consumer Demands New food vehicles Growing population Imported Food- 15% for US New hazards

4 1. Preventive Controls 2. Inspection & Compliance 3. Response (recall plan) 4. Imported Food Safety 5. Enhanced Partnerships

5 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

6 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

7 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

8 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 Clostridium perfringens Clostridium botulinum Norovirus Cyclospora cayetanesis (berries) Hepatitis A Trichinella Shigella Hormones Antibotics phytohaemagglutinin (especially kidney beans) Mushroom toxins Patulin (apple, pear, grape) Environmental contaminants (seafood) Dioxin and dioxin-like PCBs Acrylamide (only if fried or roasted)

9 Microbiological Hazards 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 None None None Salmonella, E. coli O157:H7 Ambient Rice- Parboiled Salmonella, Clostridium perfringens, Bacillus cereus None None None Ambient Bread crumbs None None Salmonella, E. coli O157:H7 None Ambient Batters/Breaders Salmonella, E. coli 0157:H7, Clostridium perfringens, Bacillus None None cereus 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 None Hepatitis A, Norovirus None Salmonella, Listeria monocytogenes, Clostridium botulinum 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

10 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 Chemical Hazards 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* environmental contaminants (heavy metals, Frozen Seafood - cooked, bases (Aw<0.85), highly pesticides, PCB, antibiotics), ciguatoxin, shellfish processed 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

11 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

12 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 ) 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:

13 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

14 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

15 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.

16 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)

17 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

18 Preventive Controls Checklist Statu s R/Y/G PREVENTIVE CONTROLS Corporate Policy Factory Policy HACCP/Food Safety Plan Monitoring Records for Food Safety Nonconformance Records to Food Safety Incidents Food Safety Incident Investigations Corrective Actions to Nonconformance s Blank Record Forms Validation 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

19 Monitoring Monitoring of Preventive Controls Written Consistently performed (adherence) Well established Maintained as written on the procedures

20 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

21 Recall Plan Mandatory recall authority Expanded administrative detention Suspension of registration

22 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.

23 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

24 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

25 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