#### U. S. Department of Health and Human ServicesU. S. Food and Drug AdministrationCenter for Food Safety and Applied NutritionMarch 21, 2003

## Guidance for Industry

# Food Producers, Processors, and Transporters:Food Security Preventive Measures Guidance

**This guidance represents the Agency's current thinking on the kinds of measures thatfood establishments may take to minimize the risk that food under their control will besubject to tampering or other malicious, criminal, or terrorist actions. It does not createor confer any rights for or on any person and does not operate to bind FDA or the public.**

Purpose and Scope:

This guidance is designed as an aid to operators of food establishments (firms thatproduce, process, store, repack, relabel, distribute, or transport food or food ingredients).This is a very diverse set of establishments, which includes both very large and very smallentities.

This guidance identifies the kinds of preventive measures operators of food establishmentsmay take to minimize the risk that food under their control will be subject to tampering orother malicious, criminal, or terrorist actions. It is relevant to all sectors of the foodsystem, including farms, aquaculture facilities, fishing vessels, producers, transportationoperations, processing facilities, packing facilities, and warehouses. It is not intended asguidance for retail food stores or food service establishments. 

Operators of food establishments are encouraged to review their current procedures andcontrols in light of the potential for tampering or other malicious, criminal, or terroristactions and make appropriate improvements. FDA recommends that the review includeconsideration of the role that unit and distribution packaging might have in a food securityprogram. This guidance is designed to focus operator's attention sequentially on each segmentof the farm-to-table system that is within their control, to minimize the risk of tampering orother malicious, criminal, or terrorist action at each segment. To be successful, implementingenhanced preventive measures requires the commitment of management and staff. Accordingly, FDArecommends that both management and staff participate in the development and review of suchmeasures. 

Limitations:

Not all of the guidance contained in this document may be appropriate or practical forevery food establishment, particularly smaller facilities and distributors. FDA recommendsthat operators review the guidance in each section that relates to a component of theiroperation, and assess which preventive measures are suitable. Example approaches are providedfor many of the preventive measures listed in this document. These examples should not beregarded as minimum standards. Nor should the examples provided be considered an inclusivelist of all potential approaches to achieving the goal of the preventive measure. FDArecommends that operators consider the goal of the preventive measure, assess whether the goalis relevant to their operation, and, if it is, design an approach that is both efficient andeffective to accomplish the goal under their conditions of operation.

Structure:

This guidance is divided into five sections that relate to individual components of a foodestablishment operation: management; human element - staff; human element - public; facility;and operations.

Related Guidance:

FDA has published a companion guidance document on food security entitled, "Importers andfilers: Food security preventive measures guidance" to cover the farm-to-table spectrum offood production. This document is available at:http://www.access.gpo.gov/su_docs/aces/aces140.html.

Additional Resources:*

A process called Operational Risk Management (ORM) may help prioritize the preventivemeasures that are most likely to have the greatest impact on reducing the risk of tampering orother malicious, criminal, or terrorist actions against food. Information on ORM is availablein the Federal Aviation Administration (FAA) System Safety Handbook, U.S. Department ofTransportation, FAA, December 30, 2000, Chapter 15, Operational Risk Management. The handbookis available at:http://www.asy.faa.gov/Risk/SSHandbook/Chap15_1200.PDF.

The U.S. Department of Transportation, Research and Special Programs Administration haspublished an advisory notice of voluntary measures to enhance the security of hazardousmaterials shipments. It is available athttp://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-3636-filed.pdf.The notice provides guidance to shippers and carriers on personnel, facility and en routesecurity issues. 

The U.S. Postal Service has prepared guidance for identifying and handling suspicious mail.It is available at:http://www.usps.com/news/2001/press/mailsecurity/postcard.htm.

The Federal Anti-Tampering Act (18 USC 1365) makes it a federal crime to tamper with ortaint a consumer product, or to attempt, threaten or conspire to tamper with or taint aconsumer product, or make a false statement about having tampered with or tainted a consumerproduct. Conviction can lead to penalties of up to $100,000 in fines and up to lifeimprisonment. The Act is available at:http://www.fda.gov/opacom/laws/fedatact.htm.

The National Infrastructure Protection Center (NIPC) serves as the federal government'sfocal point for threat assessment, warning, investigation, and response for threats or attacksagainst U.S. critical infrastructure. The NIPC has identified the food system as one of theeight critical infrastructures, and has established a public-private partnership with the foodindustry, called the Food Industry Information and Analysis Center (Food Industry ISAC). TheNIPC provides the Food Industry ISAC with access, information and analysis, enabling the foodindustry to report, identify, and reduce its vulnerabilities to malicious attacks, and torecover from such attacks as quickly as possible. In particular, the NIPC identifies crediblethreats and crafts specific warning messages to the food industry. Further information isavailable athttp://www.nipc.gov/ andhttp://www.foodisac.org/.

Finally, some trade associations have developed food security guidance that isappropriately focused for that specific industry. For example, the International Dairy FoodAssociation has developed a food security guidance document as an aid to the dairyindustry.

FDA encourages other trade associations to evaluate the preventive measures contained inthis FDA guidance document and adapt them to their specific products and operations and tosupplement this guidance with additional preventive measures when appropriate. FDA welcomesdialogue on the content of sector specific guidance with appropriate trade associations.

**Food Establishment Operations:**

**Management**

- Preparing for the possibility of tampering or other malicious, criminal, orterrorist actions    - assigning responsibility for security to knowledgeable individual(s) 
  - conducting an initial assessment of food security procedures and operations, which werecommend  be kept confidential
  - having a security management strategy to prepare for and respond to tampering and othermalicious, criminal, or terrorist actions, both threats and actual events, includingidentifying, segregating and securing affected product 
  - planning for emergency evacuation, including preventing security breaches duringevacuation 
  - maintaining any floor or flow plan in a secure, off-site location
  - becoming familiar with the emergency response system in the community 
  - making management aware of 24-hour contact information for local, state, and federalpolice/fire/rescue/health/homeland security agencies
  - making staff aware of who in management they should alert about potential securityproblems (24-hour contacts)
  - promoting food security awareness to encourage all staff to be alert to any signs oftampering or other malicious, criminal, or terrorist actions  or areas that may be vulnerableto such actions, and reporting any findings to identified management (for example, providingtraining, instituting a system of rewards, building security into job performancestandards)
  - having an internal communication system to inform and update staff about relevant securityissues
  - having a strategy for communicating with the public (for example, identifying a mediaspokesperson, preparing generic press statements and background information, and coordinatingpress statements with appropriate authorities) 
- Supervision    - providing an appropriate level of supervision to all staff, including cleaning andmaintenance staff, contract workers, data entry and computer support staff, and especially,new staff  
  - conducting routine security checks of the premises, including automated manufacturinglines, utilities and critical computer data systems (at a frequency appropriate to theoperation) for signs of tampering or malicious, criminal, or terrorist actions or areas thatmay be vulnerable to such actions 
- Recall strategy    - identifying the person responsible, and a backup person
  - providing for proper handling and disposition of recalled product
  - identifying customer contacts, addresses and phone numbers 
- Investigation of suspicious activity    - investigating threats or information about signs of tampering or other malicious,criminal, or terrorist actions 
  - alerting appropriate law enforcement and public health authorities about any threats ofor suspected tampering or other malicious, criminal, or terrorist actions
- Evaluation program    - evaluating the lessons learned from past tampering or other malicious, criminal, orterrorist actions and threats
  - reviewing and verifying, at least annually, the effectiveness of the security managementprogram (for example, using knowledgeable in-house or third party staff to conduct tamperingor other malicious, criminal, or terrorist action exercises and mock recalls and to challengecomputer security systems), revising the program accordingly, and keeping this informationconfidential
  - performing random food security inspections of all appropriate areas of the facility(including receiving and warehousing, where applicable) using knowledgeable in-house or thirdparty staff, and keeping this information confidential
  - verifying that security contractors are doing an appropriate job, when applicable 

**Human element - staff**

Under Federal law, food establishment operators are required to verify the employmenteligibility of all new hires, in accordance with the requirements of the Immigration andNationality Act, by completing the INS Employment Eligibility Verification Form(INS Form I-9). Completion of Form I-9 for new hires is required by 8 USC 1324a andnondiscrimination provisions governing the verification process are set forth at 8 USC1324b.

FDA recommends that food establishment operators consider:

- Screening (pre-hiring, at hiring, post-hiring)    - examining the background of all staff (including seasonal, temporary, contract, andvolunteer staff, whether hired directly or through a recruitment firm) as appropriate to theirposition, considering candidates' access to sensitive areas of the facility and the degree towhich they will be supervised and other relevant factors (for example, obtaining and verifyingwork references, addresses, and phone numbers, participating in one of the pilot programsmanaged by the Immigration and Naturalization Service and the Social Security Administration[These programs provide electronic confirmation of employment eligibility for newly hiredemployees. For more information call the INS SAVE Program toll free at 1-888-464-4218, fax arequest for information to (202) 514-9981, or write to US/INS, SAVE Program, 425 I Street,NW, ULLICO-4th Floor, Washington, DC 20536. These pilot programs may not be available in allstates], having a criminal background check performed by local law enforcement or by acontract service provider [Remember to first consult any state or local laws that may apply tothe performance of such checks])  
Note: screening procedures should be applied equally to all staff,regardlessof race, national origin, religion, and citizenship or immigration status.
  
Daily work assignments
- knowing who is and who should be on premises, and where they should be located, for eachshift
- keeping information updated
  
Identification
- establishing a system of positive identification and recognition that is appropriate tothe nature of the workforce (for example, issuing uniforms, name tags, or photo identificationbadges with individual control numbers, color coded by area of authorized access), whenappropriate 
- collecting the uniforms, name tag, or identification badge when a staff member is nolonger associated with the establishment
  
Restricted access
- identifying staff that require unlimited access to all areas of the facility 
- reassessing levels of access for all staff periodically 
- limiting access so staff enter only those areas necessary for their job functions and onlyduring appropriate work hours (for example, using key cards or keyed or cipher locks for entryto sensitive areas, color coded uniforms [remember to consult any relevant federal, state orlocal fire or occupational safety codes before making any changes])  
- changing combinations, rekeying locks and/or collecting the retired key card when astaff member who is in possession of these is no longer associated with the establishment, andadditionally as needed to maintain security
  
Personal items
- restricting the type of personal items allowed in establishment
- allowing in the establishment only those personal use medicines that are necessary for thehealth of staff and ensuring that these personal use medicines are properly labeled and storedaway from food handling or storage areas
- preventing staff from bringing personal items (for example, lunch containers, purses) intofood handling or storage areas 
- providing for regular inspection of contents of staff lockers (for example, providingmetal mesh lockers, company issued locks), bags, packages, and vehicles when on companyproperty (Remember to first consult any federal, state, or local laws that may relate to suchinspections)
  
Training in food security procedures
- incorporating food security awareness, including information on how to prevent, detect,and respond to tampering or other malicious, criminal, or terrorist actions or threats, intotraining programs for staff, including seasonal, temporary, contract, and volunteer staff
- providing periodic reminders of the importance of security procedures (for example,scheduling meetings, providing brochures or payroll stuffers)
- encouraging staff support (for example, involving staff in food security planning andthe food security awareness program, demonstrating the importance of security procedures tothe staff)
  
Unusual behavior
- watching for unusual or suspicious behavior by staff (for example, staff who, withoutan identifiable purpose, stay unusually late after the end of their shift, arrive unusuallyearly, access files/information/areas of the facility outside of the areas of theirresponsibility; remove documents from the facility; ask questions on sensitive subjects;bring cameras to work)
  
Staff health
- being alert for atypical staff health conditions that staff may voluntarily report andabsences that could be an early indicator of tampering or other malicious, criminal, orterrorist actions (for example, an unusual number of staff who work in the same part of thefacility reporting similar symptoms within a short time frame), and reporting such conditionsto local health authorities

**Human element -- public**

FDA recommends that food establishment operators consider:
- Visitors (for example, contractors, supplier representatives, deliverydrivers, customers, couriers, pest control representatives, third-party auditors, regulators,reporters, tours)    - inspecting incoming and outgoing vehicles, packages and briefcases for suspicious,inappropriate or unusual items or activity, to the extent practical
  - restricting entry to the establishment (for example, checking visitors in and out atsecurity or reception, requiring proof of identity, issuing visitors badges that are collectedupon departure, accompanying visitors) 
  - ensuring that there is a valid reason for the visit before providing access to thefacility - beware of unsolicited visitors 
  - verifying the identity of unknown visitors
  - restricting access to food handling and storage areas (for example, accompanying visitors,unless they are otherwise specifically authorized)
  - restricting access to locker room
**Facility**
FDA recommends that food establishment operators consider:
- Physical security    - protecting perimeter access with fencing or other deterrent, when appropriate
  - securing doors (including freight loading doors, when not in use and not being monitored,and emergency exits), windows, roof openings/hatches, vent openings, ventilation systems,utility rooms, ice manufacturing and storage rooms, loft areas, trailer bodies, tanker trucks,railcars, and bulk storage tanks for liquids, solids, and compressed gases, to the extentpossible (for example, using locks, "jimmy plates," seals, alarms, intrusion detectionsensors, guards, monitored video surveillance [remember to consult any relevant federal, stateor local fire or occupational safety codes before making any changes])
  - using metal or metal-clad exterior doors to the extent possible when the facility is notin operation, except where visibility from public thoroughfares is an intended deterrent(remember to consult any relevant federal, state or local fire or occupational safety codesbefore making any changes) 
  - minimizing the number of entrances to restricted areas (remember to consult any relevantfederal, state or local fire or occupational safety codes before making any changes) 
  - securing bulk unloading equipment (for example, augers, pipes, conveyor belts, and hoses)when not in use and inspecting the equipment before use 
  - accounting for all keys to establishment (for example, assigning responsibility forissuing, tracking, and retrieving keys)
  - monitoring the security of the premises using appropriate methods (for example, usingsecurity patrols [uniformed and/or plain-clothed], video surveillance)
  - minimizing, to the extent practical, places that can be used to temporarily hideintentional contaminants (for example, minimizing nooks and crannies, false ceilings)
  - providing adequate interior and exterior lighting, including emergency lighting, whereappropriate, to facilitate detection of suspicious or unusual activities
  - implementing a system of controlling vehicles authorized to park on the premises (forexample, using placards, decals, key cards, keyed or cipher locks, issuing passes for specificareas and times to visitors' vehicles)
  - keeping parking areas separated from entrances to food storage and processing areas andutilities, where practical
- Laboratory safety    - restricting access to the laboratory (for example, using key cards or keyed or cipherlocks [remember to consult any relevant federal, state or local fire or occupational safetycodes before making any changes]) 
  - restricting laboratory materials to the laboratory, except as needed for sampling or otherappropriate activities
  - restricting access (for example, using locks, seals, alarms, key cards, keyed or cipherlocks) to sensitive materials (for example, reagents and bacterial, drug, and toxin positivecontrols)
  - assigning responsibility for integrity of positive controls to a qualified individual
  - knowing what reagents and positive controls should be on the premises and keeping track ofthem
  - investigating missing reagents or positive controls or other irregularities outside anormal range of variability immediately, and alerting appropriate law enforcement and publichealth authorities about unresolved problems, when appropriate
  - disposing of unneeded reagents and positive controls in a manner that minimizes therisk that they can be used as a contaminant
- Storage and use of poisonous and toxic chemicals (for example, cleaningand sanitizing agents, pesticides)    - limiting poisonous and toxic chemicals in the establishment to those that are required forthe operation and maintenance of the facility and those that are being held for sale 
  - storing poisonous and toxic chemicals as far away from food handling and storage areas aspractical
  - limiting access to and securing storage areas for poisonous and toxic chemicals that arenot being held for sale (for example, using keyed or cipher locks, key cards, seals, alarms,intrusion detection sensors, guards, monitored video surveillance [remember to consult anyrelevant federal, state or local fire codes that may apply before making any changes])
  - ensuring that poisonous and toxic chemicals are properly labeled
  - using pesticides in accordance with the Federal Insecticide, Fungicide, and RodenticideAct  (for example, maintaining rodent bait that is in use in covered, tamper-resistant baitstations)
  - knowing what poisonous and toxic chemicals should be on the premises and keeping track ofthem
  - investigating missing stock or other irregularities outside a normal range of variationand alerting appropriate law enforcement and public health authorities about unresolvedproblems, when appropriate
**Operations**
FDA recommends that food establishment operators consider:
- Incoming materials and contract operations:    - using only known, appropriately licensed or permitted (where applicable) contractmanufacturing and packaging operators and sources for all incoming materials, includingingredients, compressed gas, packaging, labels, and materials for research anddevelopment
  - taking reasonable steps to ensure that suppliers, contract operators and transporterspractice appropriate food security measures (for example, auditing, where practical, forcompliance with food security measures that are contained in purchase and shipping contractsor letters of credit, or using a vendor approval program)
  - authenticating labeling and packaging configuration and product coding/expiration datingsystems (where applicable) for incoming materials in advance of receipt of shipment,especially for new products  
  - requesting locked and/or sealed vehicles/containers/railcars, and, if sealed, obtainingthe seal number from the supplier and verifying upon receipt, making arrangements to maintainthe chain of custody when a seal is broken for inspection by a governmental agency or as aresult of multiple deliveries 
  - requesting that the transporter have the capability to verify the location of the load atany time, when practical
  - establishing delivery schedules, not accepting unexplained, unscheduled deliveries ordrivers, and investigating delayed or missed shipments 
  - supervising off-loading of incoming materials, including off hour deliveries 
  - reconciling the product and amount received with the product and amount ordered and theproduct and amount listed on the invoice and shipping documents, taking into account anysampling performed prior to receipt 
  - investigating shipping documents with suspicious alterations
  - inspecting incoming materials, including ingredients, compressed gas, packaging, labels,product returns, and materials for research and development, for signs of tampering,contamination or damage (for example, abnormal powders, liquids, stains, or odors, evidence ofresealing, compromised tamper-evident packaging) or "counterfeiting" (for example,inappropriate or mismatched product identity, labeling, product lot coding or specifications,absence of tamper-evident packaging when the label contains a tamper-evident notice), whenappropriate
  - evaluating the utility of testing incoming ingredients, compressed gas, packaging, labels,product returns, and materials for research and development for detecting tampering or othermalicious, criminal, or terrorist action
  - rejecting suspect food 
  - alerting appropriate law enforcement and public health authorities about evidence oftampering, "counterfeiting" or other malicious, criminal, or terrorist action
- Storage    - having a system for receiving, storing, and handling distressed, damaged, returned, andrework products that minimizes their potential  for being compromised or to compromise thesecurity of other products (for example, destroying products that are unfit for human oranimal consumption, products with illegible codes, products of questionable origin, andproducts returned by consumers to retail stores)
  - keeping track of incoming materials and materials in use, including ingredients,compressed gas, packaging, labels, salvage products, rework products, and product returns
  - investigating missing or extra stock or other irregularities outside a normal range ofvariability and reporting unresolved problems to appropriate law enforcement and publichealth authorities, when appropriate
  - storing product labels in a secure location and destroying outdated or discarded productlabels
  - minimizing reuse of containers, shipping packages, cartons, etc., wherepractical
- Security of water and utilities    - limiting, to the extent practical, access to controls for airflow, water, electricity,and refrigeration
  - securing non-municipal water wells, hydrants, storage, and handling facilities
  - ensuring that water systems and trucks are equipped with backflow prevention 
  - chlorinating water systems and monitoring chlorination equipment, where practical, andespecially for non-municipal water systems
  - testing non-municipal sources for potability regularly, as well as randomly, and beingalert to changes in the profile of the results
  - staying attentive to the potential for media alerts about public water provider problems,when applicable
  - identifying alternate sources of potable water for use during emergency situationswhere normal water systems have been compromised (for example, trucking from an approvedsource, treating on-site or maintaining on-site storage)
- Finished products    - ensuring that public storage warehousing and shipping operations (vehicles and vessels)practice appropriate security measures (for example, auditing, where practical, for compliancewith food security measures that are contained in contracts or letters of guarantee) 
  - performing random inspection of storage facilities, vehicles, and vessels 
  - evaluating the utility of finished product testing for detecting tampering or othermalicious, criminal, or terrorist actions 
  - requesting locked and/or sealed vehicles/containers/railcars and providing the seal numberto the consignee 
  - requesting that the transporter have the capability to verify the location of the load atany time 
  - establishing scheduled pickups, and not accepting unexplained, unscheduled pickups 
  - keeping track of finished products
  - investigating missing or extra stock or other irregularities outside a normal range ofvariation and alerting appropriate law enforcement and public health authorities aboutunresolved problems, when appropriate 
  - advising sales staff to be on the lookout for counterfeit products and to alertmanagement if any problems are detected
- Mail/packages    - implementing procedures to ensure the security of incoming mail and packages (forexample, locating the mailroom away from food processing and storage areas, securing mailroom,visual or x-ray mail/package screening, following U.S. Postal Service guidance)  
Access to computer systems
- restricting access to computer process control systems and critical data systems to thosewith appropriate clearance (for example, using passwords, firewalls)
- eliminating computer access when a staff member is no longer associated with theestablishment
- establishing a system of traceability of computer transactions
- reviewing the adequacy of virus protection systems and procedures for backing up criticalcomputer based data systems
- validating the computer security system
   **Emergency Point of Contact:**

U.S. Food and Drug Administration5600 Fishers LaneRockville, MD 20857301-443-1240

If a food establishment operator suspects that any of his/her products that are regulatedby the FDA have been subject to tampering, "counterfeiting," or other malicious, criminal, orterrorist action, FDA recommends that he/she notify the FDA 24-hour emergency number at301-443-1240 or call their local FDA District Office. FDA District Office telephone numbersare listed at:http://www.fda.gov/ora/inspect_ref/iom/iomoradir.html.FDA recommends that the operator also notify appropriate law enforcement and public healthauthorities.
*Reference to these documents is provided for informational purposes only. Thesedocuments are not incorporated by reference into this guidance and should not be consideredto be FDA guidance.
 

See also: Bulk Over-the-Road Food TankerTransport Safety and Security Guidelines October 2003
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