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October 2007
Additional copies are available from:
Office of Food Defense, Communication and Emergency Response
Food Defense Oversight Team HFS-007
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-1622
http://www.cfsan.fda.gov/guidance.html
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
[March 2003; Updated October 2007]
Contains Nonbinding Recommendations
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 the approach 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 telephone number listed on the title page of this guidance.
This guidance is designed as an aid to operators of food importing establishments, storage warehouses, and filers. It identifies the kinds of preventive measures that they may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions.
This guidance is designed to focus operator's 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.
Operators of food importing 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. 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.
Not all of the guidance contained in this document may be appropriate or practical for every food importing establishment, particularly small 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.
This guidance is divided into five sections that relate to individual components of a cosmetics establishment operation: management, human element-staff, human element-the public, facility, and operations.
FDA has published a companion guidance document on food security, entitled, "Guidance for Food Producers, Processors, and Transporters: Food security preventive measures guidance." This document is available at: http://www.access.gpo.gov/su_docs/aces/aces140.html.
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.
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.
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.
Note: screening procedures should be applied equally to all staff, regardless of race, national origin, religion, and citizenship or immigration status.
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.
(Fillable print version is available in PDF, 1.3 MB)
Please note that the Food Defense Self Assessment Tool is derived from the above referenced guidance and we have deleted examples and references to other agencies and their regulations. We encourage users to become familiar with the guidance document before using this tool.
Mark each item either Y (Yes), N (No), N/A (Not Applicable), or Don't Know.
Prepare for the possibility of
tampering or other malicious, criminal, or terrorist actions Assign responsibility for security
to knowledgeable individual(s) Conduct an initial, confidential
assessment of food security procedures and operations Have a crisis management strategy
to prepare for and respond to tampering and other malicious, criminal, or
terrorist actions, both threats and actual events, including identifying,
segregating and securing affected product Plan for emergency evacuation,
including preventing security breaches during evacuation Become familiar with the emergency
response system in the community Make management aware of 24-hour
contact information for local, state, and federal police/fire/rescue/health/homeland
security agencies Make staff aware of who in
management they should alert about potential security problems (24-hour
contacts) Maintain any floor and food flow
plan in a secure, off-site location Promote food security awareness to
encourage all staff to be alert to any signs of tampering or malicious,
criminal, or terrorist actions or areas that may be vulnerable to such actions,
and to report any findings to identified management Have internal communication system
to inform and update staff about relevant security issues Have a strategy for communicating
with the public Identify the person responsible,
and a backup person Provide for proper handling and
disposition of recalled product Identify customer contacts,
addresses, and phone numbers Investigate threats or information
about signs of tampering or other malicious, criminal, or terrorist actions Alert appropriate law enforcement
and public health authorities about any threats of or suspected tampering or
other malicious, criminal, or terrorist actions Evaluate the lessons learned from
past tampering or other malicious, criminal, or terrorist actions and threats Review and verify, at least
annually, the effectiveness of the security management program, revise the program
accordingly Perform random food security
inspections of all appropriate areas of the facility (including receiving and
storage, where applicable) using knowledgeable in-house or third party staff Verify that security contractors
are doing an appropriate job, when applicable Know who is and who should be on
premises, and where they should be located, for each shift Keep assignment information updated Establish a system of positive
identification and recognition that is appropriate to the nature of the
workforce, when appropriate Collect the uniforms, name tag, or
identification badge when a staff member is no longer associated with the establishment Identify staff that require
unlimited access to all areas of the facility Reassess levels of access for all
staff periodically Limit access so staff enter only
those areas or have access to only those segments of the operation necessary
for their job functions and only during appropriate work hours, including
access to data operating systems for purchasing, storing and distributing
imported foods Change combinations, rekey locks
and/or collect 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 Restrict the type of personal items
allowed in non-public areas of the establishment Allow in the establishment only
those personal use medicines that are necessary for the health of staff and
ensure that these personal use medicines are properly labeled and stored away
from food handling or storage areas Prevent staff from bringing
personal items into food preparation or storage areas Provide for regular inspection of
contents of staff lockers, bags, packages, and vehicles when on company
property Incorporate food security
awareness, including information on how to prevent, detect, and respond to
tampering or other malicious, criminal, or terrorist actions or threats, into
training programs for staff, including seasonal, temporary, contract, and
volunteers Provide periodic reminders of the
importance of security procedures Encourage staff participation in
security procedures Watch for unusual or suspicious
behavior by staff Be alert for atypical staff health
conditions that staff may voluntarily report and absences that could be an
early indicator of tampering or other malicious, criminal, or terrorist
actions, and report such conditions to local health authorities Inspect incoming
and outgoing vehicles, packages and briefcases for suspicious, inappropriate or
unusual items or activity, to the extent practical Restrict entry
to the establishment Ensure that
there is a valid reason for the visit before providing access to the facility -
beware of unsolicited visitors Verify the
identity of unknown visitors Restrict access
to food handling and storage areas (for example, accompany visitors, unless
they are otherwise specifically authorized) Restrict access
to locker rooms Protect perimeter access with
fencing or other deterrent, when appropriate Secure all doors, windows, roof
openings/hatches, vent openings and trailer bodies, to the extent possible Use metal or metal-clad exterior
doors to the extent possible when the facility is not in operation, except
where visibility from public thoroughfares is an intended deterrent Secure bulk unloading equipment
when not in use and inspect the equipment before use Minimize the number of entrances to
restricted areas Account for all keys to
establishment Monitor the security of the premises
using appropriate methods Minimize to the extent practical,
places that can be used to temporarily hide intentional contaminants Provide adequate interior and
exterior lighting, include emergency lighting, where appropriate, to facilitate
detection of suspicious or unusual activity Implement a system of control
vehicles authorized to park on the premises Keep parking areas separated from
entrances to food storage and processing areas and utilities, where practical Limit poisonous and toxic chemicals
in the establishment to those that are required for the operation and
maintenance of the facility and those that are being held for sale Store poisonous and toxic chemicals
as far away from food handling and storage areas as practical Limit access to and securing
storage areas for poisonous and toxic chemicals that are not being held for Ensure that poisonous and toxic
chemicals are properly labeled Use pesticides in accordance with
the Federal Insecticide, Fungicide, and Rodenticide Act Know what poisonous and toxic
chemicals should be on the premises and keep track of them Investigate missing stock or other
irregularities outside a normal range of variation and alert appropriate law
enforcement and public health authorities about unresolved problems, when
appropriate Use only known and appropriately
licensed or permitted (where applicable) sources for all products Take reasonable steps to encourage
suppliers, distributors and transporters to practice appropriate food security
measures Authenticate labeling, packaging
configuration, tamper-evident packaging and product coding/expiration dating
systems (where applicable) in advance of receipt of shipment, especially for
new products Request locked and/or sealed
vehicles/containers/railcars, and, if sealed, obtaining the seal number from
the supplier, and verify upon receipt, making arrangements to maintain the chain
of custody when a seal is broken for inspection by a governmental agency or as
a result of multiple deliveries Request that transporters have the
capability to verify the location of the load at any time, when practical Establish delivery schedules, not
accepting unexplained, unscheduled deliveries or drivers, and investigating
delayed or missed shipments Supervise off-loading of incoming
materials, including off hour deliveries Reconcile the product and amount
received with the product and amount ordered and the product and amount listed
on the invoice and shipping documents, take into account any sampling performed
prior to receipt Investigate shipping documents with
suspicious alterations Inspect incoming products and
product returns for signs of tampering, contamination or damage or
"counterfeiting", when appropriate Inspect incoming products for
authenticity, packaging/product integrity, and evidence of unauthorized
relabeling/repackaging and verify batch/lot/container codes Verify conformance with FDA
requirements for product safety, quality, effectiveness, and labeling Evaluate the utility of testing
incoming products and product returns for detecting tampering or other
malicious, criminal, or terrorist action Develop and implement procedures
for inspecting shipping containers, vehicles Investigate damage and loss and
alert appropriate authority of discrepancies Reject suspect food Alert appropriate law enforcement
and food public health authorities about evidence of tampering,
"counterfeiting" or other malicious, criminal, or terrorist action Have a system for receiving,
storing and handling distressed, damaged, returned, and reworked products that
minimizes their potential for being compromised or to compromise the security
of other products Keep track of incoming products,
salvage products, and returned products Minimize reuse of containers,
shipping packages, cartons, etc., where practical Investigate missing or extra stock
or other irregularities outside a normal range of variability and report
unresolved problems to appropriate law enforcement and public health agencies,
when appropriate Ensure that public storage
warehousing and shipping (vehicles and vessels) practice appropriate security
measures Perform random inspection of
storage facilities, vehicles, and vessels Request locked and/or sealed
vehicles/containers/railcars and provide the seal number to the consignee Establish scheduled pickups and not
accepting unexplained, unscheduled pickups Restrict access to distribution
process to employees with appropriate clearance Request that the transporter have
the capability to verify the location of the load at any time Advise sales staff to be on the
lookout for counterfeit products during visits to customers and notify
management if any problems are detected Investigate missing or extra stock
or other irregularities outside a normal range of variation and alert
appropriate law enforcement and public health authorities about unresolved
problems, when appropriate Secure access to air intake points
for the facility, to the extent possible Examine air intake points for
physical integrity routinely Restrict access to critical
computer data systems to those with appropriate clearance Eliminate computer access when a
staff member is no longer associated with the establishment Establish a system of traceability
of computer transactions Review the adequacy of virus
protection systems and procedures for backing up critical computer based data
systems Validate and periodically
challenging the computer security system and proceduresIf a food import 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 local law enforcement and public health agencies.
(1) This guidance has been prepared by the Food Defense Oversight Team in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.
(2) 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.
The above document supercedes the previous version issued in March 21, 2003.
