This guidance represents the Agency's current thinking on the kinds of measures that food establishments may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, 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.
Purpose and Scope:
This guidance is designed as an aid to operators of food establishments (firms that produce, 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 small entities.
This guidance identifies the kinds of preventive measures operators of food establishments may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. It is relevant to all sectors of the food system, including farms, aquaculture facilities, fishing vessels, producers, transportation operations, processing facilities, packing facilities, and warehouses. It is not intended as guidance for retail food stores or food service establishments.
Operators of food establishments are encouraged to review their current procedures and controls in light of the potential for tampering or other malicious, criminal, or terrorist actions and make appropriate improvements. FDA recommends that the review include consideration of the role that unit and distribution packaging might have in a food security program. This guidance is designed to focus operator's attention sequentially on each segment of the farm-to-table system that is within their control, to minimize the risk of tampering or other malicious, criminal, or terrorist action at each segment. To be successful, implementing enhanced preventive measures requires the commitment of management and staff. Accordingly, FDA recommends that both management and staff participate in the development and review of such measures.
Limitations:
Not all of the guidance contained in this document may be appropriate or practical for every food establishment, particularly smaller facilities and distributors. FDA recommends that operators review the guidance in each section that relates to a component of their operation, and assess which preventive measures are suitable. Example approaches are provided for many of the preventive measures listed in this document. These examples should not be regarded as minimum standards. Nor should the examples provided be considered an inclusive list of all potential approaches to achieving the goal of the preventive measure. FDA recommends that operators consider the goal of the preventive measure, assess whether the goal is relevant to their operation, and, if it is, design an approach that is both efficient and effective to accomplish the goal under their conditions of operation.
Structure:
This guidance is divided into five sections that relate to individual components of a food establishment 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 and filers: Food security preventive measures guidance" to cover the farm-to-table spectrum of food 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 preventive measures that are most likely to have the greatest impact on reducing the risk of tampering or other malicious, criminal, or terrorist actions against food. Information on ORM is available in the Federal Aviation Administration (FAA) System Safety Handbook, U.S. Department of Transportation, FAA, December 30, 2000, Chapter 15, Operational Risk Management. The handbook is available at: http://www.asy.faa.gov/Risk/SSHandbook/Chap15_1200.PDF.
The U.S. Department of Transportation, Research and Special Programs Administration has published an advisory notice of voluntary measures to enhance the security of hazardous materials shipments. It is available at http://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 route security 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 or taint a consumer product, or to attempt, threaten or conspire to tamper with or taint a consumer product, or make a false statement about having tampered with or tainted a consumer product. Conviction can lead to penalties of up to $100,000 in fines and up to life imprisonment. The Act is available at: http://www.fda.gov/opacom/laws/fedatact.htm.
The National Infrastructure Protection Center (NIPC) serves as the federal government's focal point for threat assessment, warning, investigation, and response for threats or attacks against U.S. critical infrastructure. The NIPC has identified the food system as one of the eight critical infrastructures, and has established a public-private partnership with the food industry, called the Food Industry Information and Analysis Center (Food Industry ISAC). The NIPC provides the Food Industry ISAC with access, information and analysis, enabling the food industry to report, identify, and reduce its vulnerabilities to malicious attacks, and to recover from such attacks as quickly as possible. In particular, the NIPC identifies credible threats and crafts specific warning messages to the food industry. Further information is available at http://www.nipc.gov/ and http://www.foodisac.org/.
Finally, some trade associations have developed food security guidance that is appropriately focused for that specific industry. For example, the International Dairy Food Association has developed a food security guidance document as an aid to the dairy industry.
FDA encourages other trade associations to evaluate the preventive measures contained in this FDA guidance document and adapt them to their specific products and operations and to supplement this guidance with additional preventive measures when appropriate. FDA welcomes dialogue on the content of sector specific guidance with appropriate trade associations.
Food Establishment Operations:
Management
FDA recommends that food establishment operators consider:Preparing for the possibility of tampering or other malicious, criminal, or terrorist actions
having a strategy for communicating with the public (for example, identifying a media spokesperson, preparing generic press statements and background information, and coordinating press statements with appropriate authorities)
Supervision
conducting routine security checks of the premises, including automated manufacturing lines, utilities and critical computer data systems (at a frequency appropriate to the operation) for signs of tampering or malicious, criminal, or terrorist actions or areas that may be vulnerable to such actions
Recall strategy
identifying customer contacts, addresses and phone numbers
Investigation of suspicious activity
alerting appropriate law enforcement and public health authorities about any threats of or suspected tampering or other malicious, criminal, or terrorist actions
Evaluation program
Human element - staff
Under Federal law, food establishment operators are required to verify the employment eligibility of all new hires, in accordance with the requirements of the Immigration and Nationality 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 and nondiscrimination provisions governing the verification process are set forth at 8 USC 1324b.
FDA recommends that food establishment operators consider:
Screening (pre-hiring, at hiring, post-hiring)
examining the background of all staff (including seasonal, temporary, contract, and volunteer staff, whether hired directly or through a recruitment firm) as appropriate to their position, considering candidates' access to sensitive areas of the facility and the degree to which they will be supervised and other relevant factors (for example, obtaining and verifying work references, addresses, and phone numbers, participating in one of the pilot programs managed by the Immigration and Naturalization Service and the Social Security Administration [These programs provide electronic confirmation of employment eligibility for newly hired employees. For more information call the INS SAVE Program toll free at 1-888-464-4218, fax a request 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 all states], having a criminal background check performed by local law enforcement or by a contract service provider [Remember to first consult any state or local laws that may apply to the performance of such checks])
Note: screening procedures should be applied equally to all staff, regardless of race, national origin, religion, and citizenship or immigration status.
Daily work assignments
keeping information updated
Identification
collecting the uniforms, name tag, or identification badge when a staff member is no longer associated with the establishment
Restricted access
changing combinations, rekeying locks and/or collecting the retired key card when a staff member who is in possession of these is no longer associated with the establishment, and additionally as needed to maintain security
Personal items
providing for regular inspection of contents of staff lockers (for example, providing metal mesh lockers, company issued locks), bags, packages, and vehicles when on company property (Remember to first consult any federal, state, or local laws that may relate to such inspections)
Training in food security procedures
encouraging staff support (for example, involving staff in food security planning and the food security awareness program, demonstrating the importance of security procedures to the staff)
Unusual behavior
watching for unusual or suspicious behavior by staff (for example, staff who, without an identifiable purpose, stay unusually late after the end of their shift, arrive unusually early, access files/information/areas of the facility outside of the areas of their responsibility; remove documents from the facility; ask questions on sensitive subjects; bring cameras to work)
Staff health
Human element -- public
FDA recommends that food establishment operators consider:
Visitors (for example, contractors, supplier representatives, delivery drivers, customers, couriers, pest control representatives, third-party auditors, regulators, reporters, tours)
FDA recommends that food establishment operators consider:
Physical security
keeping parking areas separated from entrances to food storage and processing areas and utilities, where practical
Laboratory safety
disposing of unneeded reagents and positive controls in a manner that minimizes the risk that they can be used as a contaminant
Storage and use of poisonous and toxic chemicals (for example, cleaning and sanitizing agents, pesticides)
FDA recommends that food establishment operators consider:
Incoming materials and contract operations:
alerting appropriate law enforcement and public health authorities about evidence of tampering, "counterfeiting" or other malicious, criminal, or terrorist action
Storage
minimizing reuse of containers, shipping packages, cartons, etc., where practical
Security of water and utilities
identifying alternate sources of potable water for use during emergency situations where normal water systems have been compromised (for example, trucking from an approved source, treating on-site or maintaining on-site storage)
Finished products
advising sales staff to be on the lookout for counterfeit products and to alert management if any problems are detected
Mail/packages
implementing procedures to ensure the security of incoming mail and packages (for example, 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
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
301-443-1240
If a food establishment operator suspects that any of his/her products that are regulated by the FDA have been subject to tampering, "counterfeiting," or other malicious, criminal, or terrorist action, FDA recommends that he/she 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. FDA recommends that the operator also notify appropriate law enforcement and public health authorities.
See also: Bulk Over-the-Road Food Tanker Transport Safety and Security Guidelines October 2003