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November 2003
Additional copies are available from:
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2359
http://www.cfsan.fda.gov/guidance.html
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Purpose and Scope:
This guidance is designed as an aid to operators of retail food stores and food service establishments (for example, bakeries, bars, bed-and-breakfast operations, cafeterias, camps, child and adult day care providers, church kitchens, commissaries, community fund raisers, convenience stores, fairs, food banks, grocery stores, interstate conveyances, meal services for home-bound persons, mobile food carts, restaurants, and vending machine operators). 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 they may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. Operators of food retail food stores and food service 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.
This guidance is designed to focus operators' attention sequentially on each segment of the food delivery 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.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Limitations:
Not all of the guidance contained in this document may be appropriate or practical for every retail food store or food service establishment, particularly smaller facilities. 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 retail food store or food service establishment operation: management, human element-staff, human element-public, facility, and operations.
Related Guidance:
FDA has published two companion guidance documents on food security, entitled, "Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance" and "Importers and Filers: Food Security Preventive Measures Guidance" to cover the farm-to-table spectrum of food production. Both documents are available at: http://www.cfsan.fda.gov/~dms/guidance.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; 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 Sharing 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, FDA encourages trade associations to evaluate the preventive measures contained in this 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.
FDA recommends that retail food store and food service establishment operators consider:
Preparing for the possibility of tampering or other malicious, criminal, or terrorist events
Supervision
Investigation of suspicious activity
Evaluation program
Under Federal law, retail food store and food service 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 1324b.
FDA recommends that retail food store and food service 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])
Daily work assignments
Identification
Restricted access
Personal items
Training in food security procedures
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
FDA recommends that retail food store and food service establishment operators consider:
Customers
Other visitors (for example, contractors, sales representatives, delivery drivers, couriers, pest control representatives, third-party auditors, regulators, reporters, tours)
FDA recommends that retail food store and food service establishment operators consider:
Physical security
Storage and use of poisonous and toxic chemicals (for example, cleaning and sanitizing agents, pesticides) in non-public areas
FDA recommends that retail food store and food service establishment operators consider:
Incoming products
Storage
Food service and retail display
Security of water and utilities
Mail/packages
implementing procedures to ensure the security of incoming mail and packages
Access to computer systems
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
301-443-1240
If a retail food store or food service 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 recommends that the operator also notify local law enforcement and public health authorities.
FDA District Office telephone numbers are listed at: http://www.fda.gov/ora/inspect_ref/iom/iomoradir.html.
*Reference to these documents is provided for informational purposes only. These documents are not incorporated by reference into this guidance and should not be considered to be FDA guidance.