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
[July 2003; Updated October 2007]
Contains Nonbinding Recommendations
Table of Contents
Guidance for Industry(1)
Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors: Food Security Preventive Measures Guidance
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.
I. INTRODUCTION
This guidance is designed as an aid to operators of dairy
farms, bulk milk transportation operations, bulk milk transfer stations and
fluid milk processing facilities. It identifies the kinds of preventive
measures operators of these establishments may take to minimize the risk that
fluid milk under their control will be subject to tampering or other malicious,
criminal, or terrorist actions.
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.
II. BACKGROUND
Operators of these 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.
Not all of the guidance contained in this document may be
appropriate or practical for every dairy farm, bulk milk transportation
operation, bulk milk transfer station, or fluid milk processing facility. FDA
recommends that operators of these establishments review the guidance in each
section that relates to a component of their operation, and assess which
preventive measures are suitable. FDA further 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.
III. DISCUSSION
This guidance is divided into four sections: management;
human element; facility; and operations.
Related Guidance:
Additional food security guidance
that may also be applicable to operators of these establishments is contained
in an FDA guidance document entitled, "Food Producers, Processors, and
Transporters: Food Security Preventive Measures Guidance." This document
is available at: http://www.cfsan.fda.gov/~dms/secguid6.html.
IV. Recommended Actions
A. Management
- Conducting an initial assessment of the adequacy of food security
procedures and operations, which we recommend be kept confidential.
- Developing a security 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.
- Developing a product recall strategy
- Providing training in food security awareness to encourage all
staff to be alert to any signs of tampering or other malicious, criminal or
terrorist actions or areas that may be vulnerable to such actions, and report
any findings to management. The training may also encourage staff to be alert
to the presence of unidentified or unknown individuals or individuals that are
in areas to which they are not designated access, and to directly question such
individuals or report them to management
- Providing appropriate supervision to all staff with access to raw
and pasteurized milk storage, vitamin supplement receiving and storage, and
milk processing and packaging areas of the facility, including cleaning,
maintenance and quality control staff, seasonal, temporary, contract, and
volunteer staff, and especially, new staff. The supervision may include watching
for unusual or suspicious behavior by staff (e.g., 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)
- Conducting routine security checks of the raw and pasteurized
milk storage, vitamin supplement receiving and storage, and milk processing and
packaging areas of the facility, for signs of tampering or malicious, criminal
or terrorist actions or areas that may be vulnerable to such actions.
- Alerting appropriate law enforcement and public health
authorities about any threats of or suspected tampering or other malicious,
criminal or terrorist actions. FDA may be contacted through its 24-hour
emergency number, 301-443-1240, or through a local FDA District Office. FDA
District Office telephone numbers are listed at: http://www.fda.gov/ora/inspect_ref/iom/iomoradir.html.
- Reviewing, at least annually, the effectiveness of the food
security plan, using knowledgeable in-house or third party staff, and revising
the program accordingly, which we recommend be kept confidential.
B. Human Element
- Obtaining and verifying work references, addresses and phone
numbers of all staff with access to raw and pasteurized milk storage, vitamin
supplement receiving and storage, and milk processing and packaging areas of
the facility, including cleaning, maintenance and quality control staff,
seasonal, temporary, contract, and volunteer staff.
- Having a criminal background check performed by local law
enforcement or by a contract service provider for the above listed staff,
except if such staff are under direct supervision when they access the above
listed areas.
- Limiting access to raw and pasteurized milk storage, vitamin
supplement receiving and storage, and milk processing and packaging areas of
the facility to those staff that need to enter because of their job functions
and only during appropriate work hours.
- Preventing staff from bringing personal items (e.g., lunch
containers, purses) into raw and pasteurized milk storage, vitamin supplement
receiving and storage, and milk processing and packaging areas of the facility.
- Being 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 (e.g., an unusual number of
staff who work in the same part of the facility reporting similar symptoms
within a short time frame), and reporting such conditions to local health
authorities.
- Accompanying all visitors.
C. Facility
- 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, loft areas, trailer bodies,
tanker trucks, and bulk storage tanks, to the extent possible.
- Inspecting bulk unloading equipment and pumps in the receiving
area before use.
- Monitoring the security of the premises.
- Locking or sealing, with serially numbered seals, all entrances
to the milk house or all entry ports on the bulk milk tank from the time the
bulk milk tank is washed until the time it is emptied, except when it is under
direct, visual supervision (Remember to first make arrangements with the State
regulatory agency that will ensure that the regulatory agency, rating agency
and FDA continue to have ready access to the milk house and milking operation
for routine inspections, Grade "A" IMS ratings and FDA check ratings,
when applicable).
D. Operations
- Vitamin Supplements and Laboratory
Supplies
- Using only known, appropriately licensed or permitted (where
applicable) sources for vitamin supplements.
- Establishing delivery schedules for vitamin supplements, not
accepting unexplained, unscheduled deliveries or drivers, and investigating
delayed or missed shipments.
- Supervising off-loading of incoming vitamin supplements,
laboratory reagents and positive controls, including off-hour deliveries.
- Reconciling the product and amount received with the product and
amount ordered and the product and amount listed on the invoice and shipping
documents.
- Investigating shipping documents with suspicious alterations.
- Inspecting incoming vitamin supplements for signs of tampering,
contamination or damage (e.g., abnormal powders, liquids, stains, or odors,
evidence of resealing) or "counterfeiting" (e.g., inappropriate or mismatched
product identity, labeling, product lot coding or specifications).
- Storing vitamin supplements, laboratory reagents, and positive
controls in a secure location.
- Keep track of vitamin supplements, laboratory reagents and
positive controls and investigating any missing or extra stock outside a
predetermined normal range of variability.
- Labeling
- Storing product labels in a secure location and destroying
outdated or discarded labels.
- Raw Milk
- Accepting only those incoming tanker loads of raw milk for which
all openings were either locked or sealed, with a serially numbered seal, from
the time the tanker was last washed until the load is delivered. Exception may
be provided for incoming loads for which a thorough investigation demonstrates
that there is a verified, reasonable explanation for a deviation. Seals or
locks need not be in place during those times that the tanker was under the
direct, visual supervision of the driver.
- Using only known, reputable transportation companies.
- Establishing delivery schedules for raw milk, not accepting
unexplained, unscheduled deliveries or drivers, and investigating delayed or
missed shipments. We recommend that driver identification include the name of
the transportation company.
- Supervising off-loading of incoming milk.
- Reconciling the amount received with the amount listed on the
shipping documents.
- Verifying that operators of bulk milk transfer stations that
supply raw milk adhere to the preventive measures listed in this guidance.
- Locking or sealing, with a serially numbered seals, every tanker
from the time it is last washed until the time the load of milk is delivered to
the bulk milk transfer station or fluid milk processing facility. Seals or
locks need not be in place during those times that the tanker is under the
direct, visual supervision of the driver.
Emergency Point of Contact:
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
301-443-1240
If a dairy farm, bulk milk transporter, bulk milk transfer station
or fluid milk processor suspects that any of their products that are regulated
by the FDA have been subject to tampering, "counterfeiting," or other
malicious, criminal, or terrorist action, FDA recommends that they 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 they also notify appropriate law enforcement and public
health authorities.
V. Appendix: Food Defense Self Assessment Tool for Dairy Farms, Bulk
Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors
(Fillable print version is available in PDF, 1 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 guidance document before using this tool.
Mark each item either Y (Yes), N (No), N/A (Not Applicable), or Don't Know.
Dairy Establishment Operations:
Management
- Conduct an initial assessment of
the adequacy of food security procedures and operations
- Develop a security 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.
- Develop a product recall strategy
- Provide training in food security
awareness to encourage all staff to be alert to any signs of tampering or other
malicious, criminal or terrorist actions or areas that may be vulnerable to
such actions, and report any findings to management.
- Provide appropriate supervision to
all staff with access to vulnerable areas of the facility, including cleaning,
maintenance and quality control staff, seasonal, temporary, contract, and
volunteer staff, and especially, new staff.
- Conduct routine security checks of
the raw and pasteurized milk storage, vitamin supplement receiving and storage,
and milk processing and packaging areas of the facility, for signs of tampering
or malicious, criminal or terrorist actions or areas that may be vulnerable to
such actions.
- Alert appropriate law enforcement
and public health authorities about any threats of or suspected tampering or
other malicious, criminal or terrorist actions.
- Review, at least annually, the
effectiveness of the food security plan, use knowledgeable in-house or third
party staff, and revise the program accordingly
Human element
- Obtain and verify work references,
addresses and phone numbers of all staff with access to raw and pasteurized
milk storage, vitamin supplement receiving and storage, and milk processing and
packaging areas of the facility, including cleaning, maintenance and quality
control staff, seasonal, temporary, contract, and volunteer staff.
- Have a criminal background check
performed by local law enforcement or by a contract service provider for the
above listed staff, except if such staff are under direct supervision when they
access the above listed areas.
- Limit access to raw and pasteurized
milk storage, vitamin supplement receiving and storage, and milk processing and
packaging areas of the facility to those staff that need to enter because of
their job functions and only during appropriate work hours.
- Prevent staff from bringing
personal items into raw and pasteurized milk storage, vitamin supplement
receiving and storage, and milk processing and packaging areas of the facility.
- 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
- Accompany all visitors.
Facility
- Secure all doors, windows, roof
openings/hatches, vent openings, ventilation systems, utility rooms, loft
areas, trailer bodies, tanker trucks, and bulk storage tanks, to the extent
possible.
- Inspect bulk unloading equipment
and pumps in the receiving area before use.
- Monitoring the security of the
premises.
- Lock or seal, with serially
numbered seals, all entrances to the milk house or all entry ports on the bulk
milk tank from the time the bulk milk tank is washed until the time it is
emptied, except when it is under direct, visual supervision
Operations
Vitamin
supplements and laboratory supplies
- Use only known, appropriately
licensed or permitted (where applicable) sources for vitamin supplements.
- Establish delivery schedules for
vitamin supplements, not accepting unexplained, unscheduled deliveries or
drivers, and investigating delayed or missed shipments.
- Supervise off-loading of incoming
vitamin supplements, laboratory reagents and positive controls, 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.
- Investigate shipping documents with
suspicious alterations.
- Inspect incoming vitamin
supplements for signs of tampering, contamination or damage or "counterfeiting"
- Store vitamin supplements,
laboratory reagents, and positive controls in a secure location.
- Keep track of vitamin supplements,
laboratory reagents and positive controls and investigate any missing or extra
stock outside a predetermined normal range of variability.
Labeling
- Store product labels in a secure
location and destroy outdated or discarded labels
Raw milk
- Accept only those incoming tanker
loads of raw milk for which all openings were either locked or sealed, with a
serially numbered seal, from the time the tanker was last washed until the load
is delivered. Exception may be provided for incoming loads for which a thorough
investigation demonstrates that there is a verified, reasonable explanation for
a deviation. Seals or locks need not be in place during those times that the
tanker was under the direct, visual supervision of the driver.
- Use only known, reputable
transportation companies
- Establish delivery schedules for
raw milk, not accepting unexplained, unscheduled deliveries or drivers, and
investigating delayed or missed shipments.
- Supervise off-loading of incoming
milk.
- Reconcile the amount received with
the amount listed on the shipping documents.
- Verify that operators of bulk milk
transfer stations that supply raw milk adhere to the preventive measures listed
in this checklist.
- Lock or seal, with a serially
numbered seals, every tanker from the time it is last washed until the time the
load of milk is delivered to the bulk milk transfer station or fluid milk
processing facility. Seals or locks need not be in place during those times
that the tanker is under the direct, visual supervision of the driver.
If a dairy farm, bulk milk transporter, bulk milk transfer station or fluid milk processor 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.