Animal Feed Safety System P Timothy E. Costigan Manager of Quality and Analytical Services Prince Agri Products, Inc.

Mineral Premix System P l Controlled Formulations l Computer Controlled Ingredient Addition l Manual Double Checks l Electronic Scale Records Bag Break Bulk Tanks Mini Bins Load Cells Mixer Bagger Packing Tank HD

Production System Checks l Raw Materials - Ingredient specifications based on: l Supplier process l End use l Known hazards - Inbound ingredients sampled / retained for 1 year - Scheduled chemical and physical analyses l By lot, by shipment, by month l Complete analysis (annual) P

Ingredient Evaluation l Analysis Requirement for Zinc Oxide - Zn (formulated value) - Pb, Cd, As (process issue / known hazards) l Annual Review - Analyses listed above - Zn Metal (process issue) - Dioxin (known hazard) - Scan for 70 trace elements, densities, particle size, and moisture P

l Production Process - Appearance check - Batch yields - Periodic analysis - Batch samples are retained for 1 year - Magnet inspection - Inventory reconciliation P Production System Checks

l Custom formulas l Tags/preprinted bags l Mix records l Scale records l Receiving records P Records l Shipping records l Load sheets l Sales records l Analytical records l Audit records Controlled Distribution Traceable through item number / lot number

l Ingredients: - Resale ingredients by supplier’s lot number - Consumed macro and trace ingredients by shipment (applied lot number) - Consumed micro ingredients by supplier’s lot number l Finished Product: - By applied lot number P Traceability

l Visitors - Must sign in and out, visitor’s tag issued - Must be accompanied by an employee l Employees - Background checks before hiring - Training of employees on procedure l Materials - Seals on inbound and outbound loads (sans LTL) - Inspection of trailers, review of paperwork P Biosecurity

Contamination Concerns l Chemical - Toxic elements (Pb, Cd, As, Hg) - Cross contamination / incomplete blending - Organic (pesticides, lubricants) l Microbial and biological - Limited concern (insects, rodents) l Physical - Metal and glass P

l Document and Data Control (3) l Purchasing (5) l Product Identification and Traceability (2) l Process Control (18) l Inspection and Testing (17) l Control of Inspections, Measuring and Test Equipment (5) P Controlled Documents

P l Inspection and Test Status (3) l Control of Nonconforming Product (1) l Corrective and Preventive Action (2) l Handling, Storage, Packaging, Preservation and Delivery (3) l Control of Quality Records (1) l Training (1)

l Production Personnel: - Monthly safety audits - Weekly sanitation audits - Periodic procedural audits - Periodic dock audits l Quality Unit: - Annual comprehensive audits - Annual formulations audit P Audits

Statistical Techniques l Yearly Mix Plant Error Assessments - Raw Material Variation - Ingredient Addition Error - Mixing and Segregation Error - Sampling and Analytical Error l Semiannual Mixing System Evaluations l Quarterly Bag Weight Studies P

l Ingredients - Scheduled sample submission is based on: l Supplier history and the amount of shared data l Ingredient variation / previous concerns - Complete analysis yearly l Premixes - Every batch - safety or quality concern - Single batch - process check - Production issue P Analytical Work

P Overall Quality Program l Apply portions of existing programs that apply - HACCP for risk assessment - ISO for document control, procedures - GMP for hygiene, traceability, contamination issues l Focus on preventative measures - Ingredient quality - Process evaluation - Confirmatory testing