FIELD INSTRUCTIONS This document is intended to be used by food regulatory officials during regular inspections/audits of facilities that handle food, including producers, manufacturers, packers, distributors, warehousers and transporters of food and food ingredients, and retail establishments. It is designed as an aid in identifying the kinds of preventive measures that a food establishment could take to minimize the risk that food under its control could be subject to tampering or terrorist actions. Based on the conditions observed during the inspection, the appropriate material in this document should be discussed with management of the food establishment and a copy of the document provided during the close-out meeting. Additionally, any weaknesses in these preventive measures identified during the inspection should be discussed with management, but should not ordinarily be listed as violations (e.g. on FDA-483). The fact that the discussion took place should be recorded in the inspection report (e.g. EIR) but the details of the findings in this regard need not be recorded. Food establishments should be encouraged to voluntarily implement those preventive measures that are appropriate for their operations. FOOD SECURITY GUIDANCE This guidance represents the agency's current thinking on appropriate measures that can be taken by food establishments to minimize the risk of food being subjected to tampering or terrorist actions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance is designed as an aid to operators of food establishments (i.e. firms that produce, process, store, or distribute food or food ingredients or that prepare or distribute food at retail) in identifying the kinds of preventive measures that they can take to minimize the risk that food under its control could be subject to tampering or terrorist actions. It applies to all sectors of the food system (i.e., from farm-to-table), including farms, aquiculture facilities, fishing vessels, producers, transportation operations, processing facilities, packing facilities, warehouses, and retail and food-service establishments. Operators of food establishments are encouraged to review their current procedures and controls in light of the potential for tampering or terrorist actions and make appropriate improvements. This guidance is designed to focus the operator sequentially on each segment of the farm-to-table system that is within their control, in order to minimize the risk of tampering or terrorist action at each segment. The implementation of enhanced preventive measures requires the commitment of management and employees to be successful and therefore both should participate in their development and review. This document is divided into five sections that relate to individual components of a food establishment operation: MANAGEMENT OF FOOD SECURITY: PHYSICAL SECURITY EMPLOYEES RAW MATERIALS and PACKAGING FINISHED PRODUCTS Not all of the guidance contained in this document is appropriate or practical for every food establishment. Operators should review the guidance in each section that relates to a component of their operation, and assess which preventive measures are suitable for their operation. A process called Operational Risk Management (ORM) may help operators prioritize the preventive measures that are most likely to have the greatest impact on reducing the risk of tampering or terrorist actions in their establishment (www.tsi.dot.gov). Food Establishment Operations: MANAGEMENT OF FOOD SECURITY Security procedures Assign responsibility for security Reward and hold all staff accountable for being alert to and reporting signs of tampering with product or equipment, other unusual situations, or areas that may be vulnerable to tampering Procedure for investigating unusual activity Immediately investigate all reports of unusual activity Document all investigations Report all problems to local law enforcement Physical facility - Visitors Inspect incoming and outgoing vehicles for contraband Restrict entry to the establishment (sign in and out at security or reception, proof of identity) Restrict access to food handling areas (accompanied by employee) Apply procedures to everyone, including contractors, supplier representatives, truck drivers, customers, couriers, third-party auditors, regulators, etc. PHYSICAL SECURITY Secure doors, windows, roof openings, vent openings, trailer bodies, railcars, and bulk storage tanks (e.g. locks, seals, sensors) Use metal or metal-clad doors Account for all keys to establishment. Use security patrols and video surveillance Minimize number of entrances to restricted areas Eliminate potential temporary hiding places for intentional contaminants Provide adequate lighting both interior and exterior Keep parking areas away from storage and water facilities Laboratory safety Lock up reagents and bacterial positive control cultures Restrict laboratory materials to the laboratory Keep timely and accurate inventory of reagents and positive control cultures Investigate missing reagents or cultures or other irregularities immediately and report problems to local law enforcement Storage of hazardous chemicals (e.g. cleaning and sanitizing agents, pesticides) Secure storage areas Limit access to storage areas Supervise maintenance and sanitation staff Keep timely and accurate inventory of hazardous chemicals investigate missing stock or other irregularities immediately EMPLOYEES Pre-hiring screening for all employees, including seasonal, temporary and contract Obtain work references Perform criminal background checks (state and local laws may apply) Daily Rosters Make them specific to shift Know who is and who should be on premises, and where they should be located Identification Issue photo identification badges Restricted access Limit access to those areas necessary for the employee's position (e.g. card entry to sensitive areas) Personal items Restrict personal items allowed in establishment Prohibit personal items (e.g. lunch containers, purses) in food handling areas Training in security procedures Computer systems Access Restrict access to computer process control systems and critical data systems to those with appropriate clearance (e.g. passwords) RAW MATERIALS AND PACKAGING Suppliers Use only known, secure, state or locally licensed or permitted sources for all ingredients, compressed gas, packaging, and labels Include in purchase and shipping contracts a requirement that suppliers and transporters practice appropriate food security measures Inspect incoming ingredients, compressed gas, packaging, labels, and product returns for signs of tampering or counterfeiting Require transportation companies to conduct background checks on drivers and other employees with access to the product (state and local laws may apply) Require locked and sealed vehicles/containers, and require seal numbers to be identified on shipping documents Traceability of ingredients, compressed gas, packaging, and labels, salvage products, rework products, and product returns Include in purchasing contracts a requirement that suppliers be able to trace their outgoing shipments to specific incoming shipments Use operating procedures that permit subsequent identification of source of ingredients, compressed gas, packaging, labels, salvage products, rework products, and product returns for every finished product lot Keep timely and accurate inventory of ingredients, packaging, labels, salvage products, rework products, and product returns Investigate missing stock or other irregularities and report any problems to local law enforcement Security of water Secure water wells, storage and handling facilities Test for potability regularly Identify alternate sources of potable water (treat on-site or on-site storage) FINISHED PRODUCTS Security of finished products Keep timely and accurate inventory of finished products Investigate missing stock or other irregularities and report any problems to local law enforcement Include in contracts for public storage warehousing and shipping (vehicles and vessels) a requirement that they practice appropriate security measures Perform random inspection of storage facilities, vehicles, and vessels Require transportation companies and warehouses to conduct background checks on staff (drivers/warehouse personnel) (state and local laws may apply) Require locked and sealed vehicles/containers, and identify seal numbers on shipping documents Use tamper-evident packaging and identify on the package the method used to facilitate consumer verification Traceability of finished product Use finished product coding with appropriate specificity Include in sales/distribution contracts a requirement that customers be able to trace their incoming shipments to specific outgoing shipments Maintain records of product distribution, including product code and consignee Security Plans: Action Plan for tampering or terrorist event Include step-by-step SOP for trailing the event Include evacuation plan Maintain floor and flow plan in secure location and with local fire officials Include strategy for continued production (e.g. at alternate facility) Include investigation procedures Develop relationship with analytical or forensic laboratory Communication protocol Have internal, fire, and police emergency phone numbers available Identify critical decision-makers Identify local, state, and federal government contacts Designate and train a media spokesperson Develop a relationship with local print and broadcast media Prepare generic press statements and background information Recall plan Designate the person responsible, and a back-up Ensure that the plan is up-to-date Evaluation: Evaluation program Evaluate the lessons learned from past tampering or terrorist events Annually, review and test the effectiveness of procedures and plans and revise accordingly - third party security expert preferable Perform routine, random, and documented food security inspections of facility - third party security expert preferable EMERGENCY POINT OF CONTACT: U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 If food establishments suspect that any of their products that are regulated by the FDA have been contaminated or subject to tampering, they should notify the FDA 24-hour emergency number at 301-443-1240 or call their local FDA District Office. FDA District Office telephone numbers are listed at http://www.fda.gov/ora/inSpect_ref/iom/iomoradir.html. If food establishments are aware of criminal activity regarding these products, they should call the FDA Office of Criminal Investigations at 301-294-4030. For more general information about food safety, visit the World Wide Web at http://www.foodsafety.gov or http://www.cfsan.fda.gov, or call 1 -800-SAFEFOOD.     COPYRIGHT©2005 VICTORIA PACKING CORP. ALL RIGHTS RESERVED ( CTR-110505-FDA)