GUIDANCE FOR INDUSTRY FOOD PRODUCERS, PROCESSORS, TRANSPORTERS, AND RETAILERS: FOOD SECURITY PREVENTIVE MEASURES GUIDANCE

Transcription

1 GUIDANCE FOR INDUSTRY FOOD PRODUCERS, PROCESSORS, TRANSPORTERS, AND RETAILERS: FOOD SECURITY PREVENTIVE MEASURES GUIDANCE This guidance represents the Agency s current thinking on appropriate Se,: [ measures that can be taken by food estabishments to minimize the risk ii fa foad being subjected to tampering or crimina 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 pubic. This guidance is being issued in accordance : :5 with FDA s Good Guidance Practices reguation (21 CFR ; 65 FR _I. f 56468; September 19,200O).?,I This guidance is designed as an aid to operators of fuod estabishments (i.e. 1. *., 3 firms that produce, process, store, repack, reabe, distribute, or transport food.:.@- food ingredients or that prepare or djstribut~ food at retai). It identifies preventive measures that they can take to minimize the risk that food under their contro wi be subject to tampering or crimina or terrorist actions. It is reevant to a sectors of the food system (i.e., from farm-to-tabe), incuding farms, aquacuture faciities, fishing vesses, producers, transpsrtation operations, processing faciities, packing faciities, warehouses, and retai and food-service estabishments. Operators of food estabishments are encouraged to review their current procedures and contros in ight of the potentia for tampering or crimina or terrorist actions and make appropriate improvements. This guidance is designed to focus operators sequentiay on each segment of the farm-to-tabe system that is within their contro, to minimize the risk of tampering or crimina or terrorist action at each segment. impementing enhanced preventive measures requires the ~~mmitmant of management and empoyees to be successfu and, therefore, both shoud participate in their deveopment and review. _a. w SI sj/*. _... _ This guidance is divided into seven sections that reate to individua components of a food estabishment operation: management of food security; physica security; empoyees; computer systems; raw materias and packaging; operations; and finished products. It aso covers security strategies and evauation of the security system. Not a of the guidance contained in this document is appropriate or practica for every food estabishment. Operators shoud review the guidance in each section that reates to a component of their operation, and assess which preventive measures are suitabe for their operation. A process caed Operationa Risk Management (ORM) may aso hep operators prioritize the preventive measures that are most ikey to have the greatest impact on reducing the risk of tampering or crimina or terrorist actions against food under their contro (See: Food Safety and Security: Operationa Risk Management Systems Approach, November 26, 2001;

2 Food Estabishment Qoerations: Management of foad security Food estabishment operators shoud consider: Seem procedures assigning respunsibi~ty fur security to quaified individua(s) encouraging a staff to be aert to any signs of tampering with product or equipment, other unusua situations, or areas that may be vunerabe to tampering, and aerting identified management abuut any findings (e.g.1 providing training, instituting a system of rewards, buiding into job performance standards) Investioation of suspicious activitv * jmrnedjat~~y investigatjng a information about suspicious activity aerting oca aw enforcement about af suspected crimina activity Supervision providing an appropriate eve of supervision to ai empuyees, incuding ceaning and maintenance staff, contract workers, data entry and computer support staff, and especiay new empoyees 0 conducting daiy security checks uf the premises far signs of tampering with product ur equipment, other unusua situations, or areas that may be vunerabe to tampering ~ai~/packa~es impementing procedures to ensure the security of incoming mai and packages (e,g., securing mairoom, visua or x-ray mai/package screening) Physica faciity Food estabishment operators shoud consider: Visitors inspecting incoming and ~utgq~ng vehices for suspicious, inappropriate ur unusua items or activity 1) restricting entry to the estabishment (e.g., checking in and out at security or reception, requiring proof of identity, issuing visitors badges - coected upon departure) ensuring that there is a vaid reason for the visit before providing access to the faciity - beware of unsoicited visitors restricting access tu fuod handing and storage areas (e.g., accompanying visitors, uness they are otherwise specificay authorized) 0 restricting access to ocker rooms * appying the above prucedures to everyone, incuding contractors, suppier representatives, truck drivers, customers, couriers, third-party auditors, reguators, reporters, visitors, etc. 2

3 3 Physica security protecting perimeter access with fencing or other appropriate deterrent securing doors (inc~udjng freight oading doors), windows, roof openings/hatches, vent openings, traier bodies, tanker trucks, raicars, and buk storage tanks for iquids, soids, and compressed gases, to the extent possibe (e,g.f using ocks, jimmy pates, sea!s, aarms, intrusion detection sensurs, guards, monitared video surveiance [remember to consut any reevant federa, state or foca fire or occupationa safety codes before making any changes]) using meta or meta-cad doors tu the extent possibe, especiay when the faciity is not in operation (remember to consut any refevant federaf, state or oca fire or occupationa safety codes before making any changes) minimizing the number of entrances to restricted areas (remember to consut any reevant federa, state or oca fire or occupationa safety codes before making any changes) accounting fur a keys to estabishment using security patros (uniformed and/or pain~c~uthed) and video surveifance, where appropriate minjmizing paces that coud be used to hide temporariy intentiona contaminants (e.g., minimizing nooks and crannies providing adequate interior and exterior ightings incuding emergency ightjng imp~ementjng a system of controing vehices authorized to park on the premises (e.g., using pacards, decas, key cards, cypher ocks) La boratarv safety restricting access tu the aboratory (e-g., using key cards or cypher ocks [remember to consuft any reevant federa, state or oca fire or occupationa safety codes before making any changes]) restricting faburatory materias to the aboratory, except as needed for samping or other appropriate activities restricting access (e.g., using ocks, seas, aarms, key cards, cypher ocks) to sensitive materias (e.g., reagents and bacteria, drug, and toxin positive contros) assigning responsjbjity for integrity of positive contros to a quaified individua keeping track of reagents and positive cuntrus investjgating missing reagents or positive contros or other irreguarities outside a pre-determined norma range of variabiity immediatey, and aerting oca aw enforcement about unresoved pruberns, when appropriate

4 Storaae end use of hazardous chemicas fe& cfeanincr and, sanitizing agents, pesticides, prucessincr aids) securing storage areas fur hazardous chemicas (e.g., using ocks, seas, aarms, intrusion detection sensors, guards, munitored video surveiance [remember to consut any state or oca fire codes that may appy before making any changes]) * imiting access to storage areas for hazardous chemicas (e.g., using key cards or cypher ocks [remember to consut any reevant federa, state or oca fire or occupationa safety codes before making any changes]) * keeping track uf hazardous chemicas + jnvestigating missing stock or other irreguarities outside a predetermined norma range of variation and aferting toca faw enfurcement about unresoved probems Empoyees Food estabishment operators shoud consider: Pre-h iri ng screen inq 0 screening empoyees (e.g., obtaining and verifying work references, addresses, and phone numbers) e checking immigration status with U.S. Immigration and Naturaization Service, when appropriate * pe~orming crimina background checks, in~udjng Federa Bureau of Investigation Watchist (remember to consut any state or foca aws that may appy to the performance of such checks) 8 appying these procedures to a empoyees, to the extent possibe, incuding seasona, temporary, contract, and vounteer empoyees Daiy work assignments knowing who is and who shoud be on premises, and where they shoud be ocated * being specific to shift * keeping i~furmation updated dentifi~ation 0 estabjshing a system of positive identi~cat~un and recognition (e.g., issuing photo identification badges with individua contro numbers, coor coded by area of authorized access) * cufecting the retired identification badge when an empoyee is terminated, either vountariy or invountariy

5 Restricted access * imiting access so empoyees enter ony those areas necessary fur their job functions (e.g., using key cards or cypher ocks to sensitive areas, coor-coded uniforms [remember to consut any reevant federa, state or oca fire or occupationa safety codes before making any changes]) * changing combinations and/or coecting the retired key card when an empoyee is terminated, either vountariy or invuuntariy, and additionay as needed to maintain security a reassessing eves of access for a empoyees periodicay Persona items restricting persona items aowed in estabishment * preventing workers from bringing persona items (e.g., unch containers, purses) intu food handing areas 0 estabishing poicy and providing fur reguar inspection of contents of empoyee ockers (e.g., provide meta mesh ockers, company-issued iocks), bags, and vehices when on company property Trainina in food security procedures- * providing food security training to a new empoyees, incuding information on how tu prevent, detect, and respond tu tampering or criminai or terrorist activity providing periodic reminders of the importance uf security procedures ensuring empoyee buy-in (e.g., invoving empoyees in food security panning, demonstratjng the importance af security procedures to the empoyees themseves) Unusua behavior * watching fur unusua behavior by new empoyees or workers (e.g., workers who stay unusuay ate after the end of their shift, arrive unusuay eary, access f~es/infurmation/areas uf the faciity outside of the areas of their responsibjity; remove documents from the faciity; ask questions on sensitive subjects; bring cameras to work) Computer systems Food estabishment operators shoud consider: Access restricting access to computer prucess controf systems and critica data systems to those with appropriate cearance (e.gvi using passwords, firewafs) 0 eiminating computer access to past empfuyees immediatey upon votuntary or ~nvou~ta~ termination * estab~ishjng a system of traceabiity of computer transactions 0 reviewing the adequacy of procedures for backing up critica computer-based data systems vaidating the computer security system 5

6 Raw materias and packaging Food estabishment operators shoud consider: Sugniers using ony known, apprupriatey icensed or permitted (where appicabe) sources for a ingredients, compressed gas, packaging, and abes taking steps to ensure that suppiers and transporters practice appropriate food security measures (e,g., auditing for compiance with food security measures that are contained in purchase and shipping contracts or etters of credit) authenticating abeing and packaging configuration in advance of receipt of shipment inspecting incoming ingredients, compressed gas, packaging, abes, and product returns for signs of tampering (e.g.$ abnorma powders, iquids, or odors) or ~uunte~ejti~g (inappropriate product identity, abeing, product ot coding ur specifications), where appropriate evauating the utiity of testing incoming ingredients, compressed gas, packaging, abes, and product returns for detecting tampering or crimina or terrorist activity requesting ocked and seaed vehi~es~~ontain~rs/raj~ars~ obtaining the sea number from the suppier, and verifying upon receipt - make arrangements to maintain the chain of custody when a sea is broken fur inspection by a governmentat agency estabishing quarantine and reease procedures reconciing the amount received with the amount ordered and the amount isted on the invoice and shipping documents, taking into account any samping performed prior to receipt supervising ok-oading of incoming jngredjents~ compressed gas, packaging, Labes, and product returns aferting foca aw enforcement about evidence of tampering ur counte~eiting keeping track of ingredients, compressed gas, packaging, abes, savage products, rework products, and product returns investigating missing or extra stock or other irreguarities outside a predetermined norma range of variabiity and reporting unresoved probems to ocaf aw enforcement, when appropriate destroying outdated or discarded product a befs 6

7 Operaticms Food estabishment operators shoud consider: Security of water securing water wes, hydrants, storage and handing faciities * ensuring that water systems and trucks are equipped with backfow prevention 0 testing for potabiity reguary, as we as randomy, and being aert tu changes in the profie uf the resuts ~h~orinatjng water systems and monituring chorination equipment 0 maintainjng contact with the pubic water provider to be aerted to probems identifying aternate sources of potabe water (e.g., trucking from an approved source, treating an-site or maintainjng on-site storage) Security of pfant air 0 securing access to air intake points for the faciity, to the extent possibe (e.g., using fences, sensors, guards, video surveiance) r) examining air intake points for physica integrity routiney Finished Products Food estabishments shoud consider: Security of finished pruducts keeping track of finished products investigating missing or extra stock or other irreguarities outside a predetermined norma range of variation and aerting oca aw enforcement about unresoved probems, when apprupriate ensuring that pubic storage warehousing and shjpping (vehices and vesses) practice appropriate security measures (e.g., auditing for compiance with food security measures that are contained in contracts or etters of guarantee) performing random inspection of storage faciities, vehictes, and vesses requesting ucked and seafed vehices/containers/rai~ars and providing the sea number to the consignee (remember to consut any reevant federa, state ur oca fire or occupationa safety codes before making any changes) advising saes staff to be on the ookout for cuunterfeit products during visits to customers and aerting management if any probems are detected evauating the utiity uf finished product testing fur detecting tampering or crimina or terrorist activity monitoring cosey the serving of foods in open dispay areas (e.g, saad bars, open buk containers) 7

8 $ecurity Stratenies Food estabishment operators shoud consider: Resoonse to tampering or crimina or terrorist event * having a strategy for triaging the event * panning fur emergency evacuation, inc~udjng preventing security breaches during evacuation or identifyjng critica decision-makers * jdentifying management that empoyees shoud aert about potentia security probems identifying 24-hour contact informatjon for oca, state, and federa poice/~re/res~ue/government agencies identjfying a media spokesperson having generic press statements and background information Recaf strategy identjfyjng the person responsibe, and a back-up providing fur proper disposition of recaed product * identifying customer contacts, addresses and phone numbers Additiona steps maintaining any foor or fow pan in a secure, off-site ocation 0 making empoyees aware of interna, fire, and poice emergency phone numbers becoming famiiar with the emergency response system and the Emergency Command Center operations in the state in which the faciity is ocated * making empoyees aware of the company officias to aert about potentia security probems, and where they can be reached Evauation: Food estabishment operators shuud consider: Evauation grogram 0 evauating the essons earned from past tampering or terrorist events 8 annuay reviewing and testing the effectiveness of strategies (e.g., conducting mock crimina, terrorist or tampering event and muck reca, chafenging computer security system) and revising accordingy - using third party or in-house security expert e performing routine and random food security inspections of faciity (intruding receiving and warehousing areas and intrusion detection system) - using third party or in-house security expert verifying that security contractors are doing an adequate job 8

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