Nut Handling and Processing for Confectioners and Small Nut Roasters Session 4: Role of Food Safety Programs in Assuring Safe Use of Nuts Tom Mackie, Food Safety Consultant to NCA Steve Calhoun, Food Safety Consultant to APC Sponsored by: In partnership with: Nut Handling & Processing for Confectioners and Small Nut Processors Role of Food Safety Programs in Assuring Safe Use of Nuts Steve Calhoun and Tom Mackie Challenges for Nut and Confectionery Processors • Handling contaminated raw commodities • Old facilities with poor traffic flow • Poor equipment design making it difficult to clean and inspect • Lack of trained and dedicated resources • Use of contract and temporary labor pool • Reliance on co-manufacturers for critical process steps • Low level of technology for quality and food safety systems support • Change management to keep up with pressure for new product and new package development Prerequisite Programs • • • • • • • Regulatory Proposals PRP Overview Facilities , Personnel , Equipment Control of Raw Materials Sanitation & Environmental Monitoring Traceability and Recall SSOPs and Process & Controls PRP Implementation • • • • • • • Microbiological Control Hazard Analysis Chemical , Allergen & Physical Hazards Documentation Training Verification HACCP Proposed Changes to Food Safety Regulations • Substantially increase regulatory burden, cost, and liability risks • Increase frequency of food facility inspections • Expanded access to company records and test results • Mandated food recalls • Written HACCP type plans • Enhanced Traceability requirements • Third party accreditation to food safety standards Prerequisite Programs A range of programs that are necessary to set the stage for HACCP-based systems and to provide on-going support for these systems. Prerequisite Programs Based on: • FDA current Good Manufacturing Practices (cGMPs) • USDA/FSIS sanitation regulations Prerequisite Programs Provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome foods. Examples of Common Prerequisite Programs • • Facilities design • Production equipment • • controls • Cleaning & sanitation • • Chemical control • • Pest control Personal hygiene Training Supplier assurance Specifications Traceability & recall Examples of Prerequisite Programs • Consumer complaint management • Sanitation Standard Operating Procedures (SSOPs) • Environmental monitoring program Facilities • Layout – Buildings, premises, equipment, and personnel movements • Segregation – Clean and unclean zones – Wet and dry zones – Air handling Facilities • Separation of raw from processed including air flow • Special attention to roof • Master Sanitation Schedule • Use of dry cleaning procedure as routine for risk areas • Dry, Dry, Dry • Nut residue accumulation removed as timely as possible • Integrated pest control management Personnel • Health and hygiene – Disease control and personal hygiene/dress code • Hygienic practices – Handling of materials – Movement in facility • Education and Training Personnel Practices • Should apply equally to contract employees • Cross contamination prevention, limit traffic between raw nut and processed nut area Poor employee practices may result in microbiological, physical or chemical contamination of foods. Production Equipment • • • • Sanitary design principles Scheduled maintenance Calibration, where applicable Monitoring activities Sanitary Design Figure 3-1. Ends of a horizontal screw conveyor – always a potential area of stagnant product build-up. Sanitary Design Figure 3-2. A flat surface that can collect product (This should be eliminated or sloped). Equipment • Cold storage equipment monitored – Raw Peanuts 1-5oC (34-41oF) – 55-70% Relative Humidity Inbound Material Control • • • • • • • Documented Specifications Certificates of Analysis / Conformance Letters of Guaranty Supplier approval program Inbound material inspection Material receiving procedures Management of material storage Supplier Assurance • Document a material management program for all ingredients and packaging • Conduct risk assessments for materials • Decide which materials present the greatest risk to the business • Determine how to audit suppliers • Build strong relationships to enable regular communication with suppliers Supplier Audits • • • • • Who conducts the audits ? Make sure the auditor is trained Provide documentation of the audit How frequently should a supplier be audited ? Make sure the supplier is clear on all specifications and expectations • Follow up on all recommendations and required corrective actions • Assure the vendor provides timely notification of all changes to material , facilities , or process Specifications • Spec.’s are documented , contractual requirements • All critical food safety parameters must be included • For nut materials these will include microbiological , aflatoxin and allergens • All special handling requirements need to be documented in the spec. • Assure spec.’s are controlled documents Specification Categories Moisture Microbiological ; bacteria , molds Rodent or insect evidence Foreign Materials ; shell , twigs/wood, metal Chemicals ; aflatoxin , pesticides Allergens Sensory ; color , flavor Nut Quality ; size , broken pieces , damage Microbiological Limits • USDA Commodity Micro Requirements for Peanut Butter Salmonella E. Coli Coliform Aerobic Plate Count Yeast Mold Negative <3.6/g MPN <10/g MPN <10,000/g <100/g <100/g Material Receiving & Storage • Material receiving procedures such as checks for seals ; COAs and sampling • Dock space and material protection • Bulk unloading and handling equipment • Isolation of raw commodities • Control of allergen cross contact potential • Warehouse space and conditions • Handling of non-conforming materials Nut Processors • • • • • • • Crop sources Harvest conditions Storage conditions Shelf life impact Lab capabilities ; micro, chemical ,aflatoxin Allergen cross contact at shellers Intermediate handlers / co-processors Confectioners • • • • • • Nut supplier locations Packaging used for nut ingredients Shipping and handling prior to delivery Receiving practices at your sites Product turnover during processing Intermediate products and rework Environmental Sanitation • • • • Know the facility layout ; wet and dry areas Dedicated tools and cleaning equipment Lean manufacturing approach Control traffic patterns throughout the process facility ; raw product containment is critical • Rely upon documented cleaning and sanitation schedules and procedures • Use product contact surface sampling to verify sanitation effectiveness • Use environmental swab testing for pathogens Equipment Cleaning and Sanitation • • • • • • • • • Dry cleaning in nut and confectionery processes Continuous operations and shut down periods Wet clean systems such as CIP and COP Focused wet cleaning of equipment Product build – up and biofilms Access to clean and to inspect the job Application of sanitizers Swab tests and bioluminescence / ATP kits Impact of GMPs and personal hygiene Environmental Swab Program • • • • • • Where and how to sample using sponges Frequency of swab sampling How to react to a positive pathogen result Control reporting and communications Confirm external lab credibility Expect programs to be implemented at suppliers and co-processors Product Testing • • • • • • • • • Product contact surface sampling protocols Raw materials monitoring Intermediate ingredients Rework Finished product composites Composite breakdowns Resampling and retesting Returned product and retained samples Strong hold management system Traceability and Recall Program • • • • • • Crisis response plan and team Lot coding and records Distribution records Product disposition Mock recalls FDA regulation (21 CFR 1) – Requires records identifying immediate previous source and immediate subsequent recipient Sanitation Regulatory Requirements • FDA – Current Good Manufacturing Practices (21 CFR 110) • SSOPs SSOPs • Should identify daily pre-op procedures • Should identify daily operational procedures • Should be signed and dated • Establishment should initiate corrective and preventative actions • Daily records should be maintained Process and Controls • Validate kill step • Do not use same equipment (conveyors, containers, etc.) for unprocessed and processed, including blanched nuts • Process disruptions – remove product • Control nut dust and other nut debris • Assure nut foreign material removed Process and Controls • If a processed product sample tests positive for Salmonella, the tested lot is considered adulterated and should not be released into commerce • Positive lots may be reprocessed , but ONLY when run through a VALIDATED process • It is critical to review adjacent lots to confirm a clean break between a positive lot and one or more lots designated as clear to release Process and Controls • Purging contaminated peanut butter lines with hot oil – Validate procedure – Recent study suggests it takes 42+/- 8 minutes at 90oC (194oF) for a 5 log reduction of Salmonella for a mixture of three outbreakassociated S. Tennessee strains in peanut butter (Doyle, May , 2009) – 49±12 min were needed to inactivate a composite of other Salmonella isolates Process and Controls • Traceability – Finished product traceable to raw material lots used – Consideration should be given for a routine clean break for bulk or continuous nut and nut butter operations Microbiological Control GMA Guidance Document • • • • Prevention Hygiene Practices and Control Hygiene Design of Buildings and Equipment Moisture Control, Minimizing growth, Dry & Wet Cleaning Practices • Raw Material Programs • Validation of Control • Verification of Controls & Corrective Actions www.gmaonline.org/science/SalmonellaControlGuidance.pdf Chemical and Physical Hazards • • • • • Aflatoxin and other Mycotoxins Pesticide Residues Heavy Metals Unintended Food Allergens Foreign Materials Proper implementation of prerequisite programs simplifies the development of a HACCP Plan. Prerequisite Programs Should Be : • • • • Well-documented with written SOPs Adhered to by all employees Reviewed and revised as needed Effective in accomplishing objectives Establishing Prerequisite Programs Documentation – What procedures should be performed? – At what frequency? – Who has responsibility? – What actions should be taken if: • a procedure is not performed as required? • there is an unexpected outcome? Establishing Prerequisite Programs Employee training – Continuing education – Important to understand and follow assigned tasks – Provide time and materials for training – Verify by reviewing performance Verification of Prerequisite Programs Periodic review of the SOPs and audit reports to ensure that the programs are operating in a manner that should not require a change in the hazard analysis or HACCP plan. Establishing Prerequisite Programs Verification – Is the SOP performed in the manner intended? – Is the procedure monitored? – Are appropriate records kept? – Is there an independent audit? – Are programs revised as necessary? Establishing Prerequisite Programs Resources – Are the proper tools/equipment available? – Are appropriate personnel available to perform the task effectively? – Are systems adequate for monitoring and storing data? Prerequisite Program or HACCP? Prerequisite Programs HACCP Plans Deal indirectly with food safety issues Deal solely with food safety issues Cross multiple product lines Specific to product & line Failures seldom result in food safety hazards Deviations must be considered potential food safety hazards Prerequisite Program or HACCP? Depending upon the results of the hazard analysis and identification of control measures, some activities normally addressed in prerequisite programs may be included in the HACCP plan. Summary • Understand all legal and regulatory requirements for nut handling & processing • Know the important PRPs that form the foundation for food safety and HACCP • Regularly train the employees that are accountable for program implementation • Verify all food safety programs perform to protect customers and consumers Questions? For Q&As and Food & Nut Safety Resource Guide: http://www.ecandy.com/Content.aspx?ContentID=7134