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GUIDANCE DOCUMENT

Guidance for Industry: Food Security Preventive Measures Guidance for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors October 2007

Final
Docket Number:
FDA-2020-D-1928
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

Available in these languages:

NOTE: The guidance below is out of date and no longer represents FDA’s current thinking. FDA issued a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration in May 2016. The agency intends to publish guidance documents to provide information relevant to the provisions of the final rule.

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.

Table of Contents

  1. INTRODUCTION
  2. BACKGROUND
  3. DISCUSSION
  4. RECOMMENDED ACTIONS
    1. Management
    2. Human Element
    3. Facility
    4. Operations
      1. Vitamin Supplements and Laboratory Supplies
      2. Labeling
      3. Raw Milk
  5. Appendix: Food Defense Self Assessment Tool for Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors
    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.

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 (Updated contact number: 1-866-300-4374 or 301-796-8240), 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

  1. 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.
  2. Labeling
    • Storing product labels in a secure location and destroying outdated or discarded labels.
  3. 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
(Updated contact number: 1-866-300-4374 or 301-796-8240)

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 (Updated contact number: 1-866-300-4374 or 301-796-8240) 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

  • Y, N, N/A, or Don't Know -    Conduct an initial assessment of the adequacy of food security procedures and operations
  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    Develop a product recall strategy
  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    Alert appropriate law enforcement and public health authorities about any threats of or suspected tampering or other malicious, criminal or terrorist actions.
  • Y, N, N/A, or Don't Know -    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

  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    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
  • Y, N, N/A, or Don't Know -    Accompany all visitors.

Facility

  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    Inspect bulk unloading equipment and pumps in the receiving area before use.
  • Y, N, N/A, or Don't Know -    Monitoring the security of the premises.
  • Y, N, N/A, or Don't Know -    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

  • Y, N, N/A, or Don't Know -    Use only known, appropriately licensed or permitted (where applicable) sources for vitamin supplements.
  • Y, N, N/A, or Don't Know -    Establish delivery schedules for vitamin supplements, not accepting unexplained, unscheduled deliveries or drivers, and investigating delayed or missed shipments.
  • Y, N, N/A, or Don't Know -    Supervise off-loading of incoming vitamin supplements, laboratory reagents and positive controls, including off-hour deliveries.
  • Y, N, N/A, or Don't Know -    Reconcile the product and amount received with the product and amount ordered and the product and amount listed on the invoice and shipping documents.
  • Y, N, N/A, or Don't Know -    Investigate shipping documents with suspicious alterations.
  • Y, N, N/A, or Don't Know -    Inspect incoming vitamin supplements for signs of tampering, contamination or damage or "counterfeiting"
  • Y, N, N/A, or Don't Know -    Store vitamin supplements, laboratory reagents, and positive controls in a secure location.
  • Y, N, N/A, or Don't Know -    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

  • Y, N, N/A, or Don't Know -    Store product labels in a secure location and destroy outdated or discarded labels

Raw milk

  • Y, N, N/A, or Don't Know -    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.
  • Y, N, N/A, or Don't Know -    Use only known, reputable transportation companies
  • Y, N, N/A, or Don't Know -    Establish delivery schedules for raw milk, not accepting unexplained, unscheduled deliveries or drivers, and investigating delayed or missed shipments.
  • Y, N, N/A, or Don't Know -    Supervise off-loading of incoming milk.
  • Y, N, N/A, or Don't Know -    Reconcile the amount received with the amount listed on the shipping documents.
  • Y, N, N/A, or Don't Know -    Verify that operators of bulk milk transfer stations that supply raw milk adhere to the preventive measures listed in this checklist.
  • Y, N, N/A, or Don't Know -    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 (Updated contact number: 1-866-300-4374 or 301-796-8240) 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.

The above document supercedes the previous version issued in July 11, 2003.

Related Information

Industry and Consumer Assistance

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1928.

 
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