Attachment 5--Food Defense Evaluation.docx

FOOD DEFENSE CHECKLIST

BACKGROUND INFORMATION: The original DLA Food Defense Checklist was developed by FTSB in October 2001 and distributed along with a precautionary letter to all contractors/subcontractors manufacturing, re- packaging, assembling, distributing, transporting, or storing operational rations during the Research Development Associates (R&DA) Conference in October 17, 2001. This alert was issued as a precaution due to the heightened state of security awareness in the USA after the September 11, 2001 terrorist attacks. While the original DLA Troop Support FD Checklist was modified and used as a model to develop "other" FD Checklists by other Government entities and industry, the basic elements developed by DLA Troop Support are the same.

FOOD DEFENSE PLAN (Operational Rations, Prime Vendor, and Others).

The Food and Drug Administration (FDA) issued a final rule effective July 26, 2016, to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduce with the intention to cause wide scale public health harm. FDA issued these requirements as part of the implementation of the Food Safety Modernization Act (FSMA).

Currently, all DLA Troop Support Subsistence contracts have a requirement for the submission, and implementation of some type of Food Defense at each contractor facility, which must be approved by DLA Troop Support. Areas of concern listed in this checklist must be addressed in the plan. As a result of increased risk for the potential of intentional food tampering the plan shall describe (in general terms) the type of preventive measures that are taken or will be taken to reduce food defense vulnerabilities and to protect the food intended for DLA Troop Support's customers at CONUS and OCONUS locations. The plan must include preventive steps taken to safeguard product from intentional tampering/ contamination during all stages of receipt, production, storage, assembly, delivery, and shipment.

This revision to the DLA/DLA Troop Support Food Defense Checklist contains the following changes:

1. Acknowledgement of The Food and Drug Administration (FDA) issued a final rule effective July 26, 2016 has been incorporated as an inherent requirement in accordance with the implementation of the Food Safety Modernization Act (FSMA). This requirement is fundamental “The DLA Troop Support Food Defense Checklist” since DLA Troop Support developed the original checklist and DLA vested all food defense responsibilities to FTSB during the FT reorganization in 2005. This change was made to clearly identify the office with “official” responsibility for food defense for all DLA Troop Support subsistence contractors and, to facilitate immediate changes should unexpected circumstances dictate the need for changes, based on DLA Troop Support audit results/site visits/risk assessments at contractors' facilities, and/or feedback from inspection agencies (e.g., USDA-AMS, USDC, US Army Food inspectors, etc.) supporting DLA Troop Support and/or changes in regulatory requirements. The goal is to clarify roles and responsibilities for food defense for all DLA Troop Support subsistence contracts and facilitate changes to food defense requirements in case of unexpected circumstances.

2. Food Defense was removed from Section V of the DLA Troop Support Quality Systems Audit Workbook I: Documented Quality Systems Plans (QSP) Evaluation Guideline and made into a standalone document. A Food Defense Plan will be evaluated with each new acquisition regardless if the location is from an incumbent or not. The previously approved plans will be given the same rating barring no changes have been made to the original approved plan. The goal is to reduce duplication and contradictions of the checklists used by subsistence contractors and DLA Troop Support personnel.

3. This document serves three purposes: (1) To communicate to prospective contractors the information that is expected to be addressed/included in their Documented Food Defense Plan submitted with their Technical Proposals/Bids. To ensure contractors address issues and respond to questions deemed critical to food defense at production facilities, ration assembly/subassembly/packaging facilities, Prime Vendor facilities, and/or other type of food distribution/ storage facilities located at CONUS and OCONUS locations; (2) Used by FTSB's Lead Auditors to determine if prospective contractors have satisfactorily addressed/included information applicable to their type of facility (3) Used by FTSB's Lead Auditors during compliance quality audits, Quality Systems Management Visits, and/or reviews to determine compliance, and effectiveness of the plan identifying vulnerabilities in the system/facility.

To download a copy of the DLA Troop Support Food Defense Checklist go to http://www.dla.mil/Portals/104/ Documents/TroopSupport/Subsistence/FoodSafety/FoodQuality/food_defense_check.pdf or contact the applicable DLA Troop Support Contracting Officer or the Quality Audits & Food Defense Branch (FTSB). Beneficial comments (recommendations, additions, deletions) and any pertinent data which may be used in improving this document should be addressed to: DLA TROOP SUPPORT, Directorate of Subsistence, Bldg. 6ATTN: FTSB, 700 Robbins Street, Philadelphia, PA19111-5092. Fax (215) 737-0379 or Voice (215) 737-8656/8523/4209.

SPE3S1-22-R-0012

Attachment 5

TABLE OF CONTENTS

Page

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

I. ESTABLISHMENT/FACILITY REGISTRATION:

See FDA Food Facility Registration User Guide: https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm324780.htm Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. If a registration is not renewed by 11:59 PM on December 31, of the even-numbered year, the registration is considered expired.

A. Does the plan clearly indicate the facility/establishment is registered with FDA as per the CFR?

B. Does the plan identify the establishment number and the date the facility was registered?

C. Is the registration date current in accordance with FDA’s Biennial Registration Renewal?

D. Is the physical address of the facility identified in the plan?

II. FOOD DEFENSE MANAGEMENT PLAN AND POLICY: Does the plan identify/ include/address the following?

A. A policy statement concerning top management support for food defense and the integrity of food supplies.

B. The risk management principles/guidelines used to develop and implement the plan (example FDA, USDA-FSIS, industry guidelines, etc.).

C. Organizational charts clearly identifying management personnel (by position) involved with the company's Food Defense.

D. Identify the Food Defense Manager/Coordinator or the responsible management official with the overall responsibility for: Reviewing the adequacy, implementation and effectiveness of plan; control and security of the plan and all copies; and determining whether a private firm is needed to assess risk or reduce food defense vulnerabilities.

E. Does the plan identify the Food Defense team members by position and their specific assigned responsibilities?

F. Does the plan clearly identify the date of last review/ revision of the plan?

G. Responsibilities for monitoring and controlling each area identified in the plan.

H. How the contractor maintains confidentiality of the plan and details that may compromise the security of the facility or the integrity of the plan.

I. Identify personnel (by position) authorized to have copies of the plan. Identify who, where, and how copies are maintained, controlled and secured.

J. Indicate if employees performing monitoring activities are delegated authority to take immediate action if there are signs that may indicate a breach in security/problem?

K. Are computer hardware, software, and paper records documenting food production controls backed -up, secure? If so, is access to these passwords controlled and changed periodically?

L. Is there a cyber-security plan? If so, is there a plan for a cyber-attack?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

III. PERSONNEL: Employees, visitors, contract workers and others.

A. Employees: 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.

1. Employee references/background checks. Does the plan identify/include/ address the following?

A. Employment references, addresses, and phone numbers supplied by employees on the application form are verified for ALL employees (seasonal, temporary, permanent, contract workers, etc.) prior to hiring.

B. If background checks are not required for ALL employees, does the plan identify employees (seasonal, temporary, permanent, and contract workers) by position, subjected to background checks before hiring?

C. Are employees hired prior to verification of employment references or background checks are completed.

D. Clearly identify the responsible official(s) with cognizance for ensuring employment references, background checks and security clearances (i.e., Top Secret or Secret) if required are verified and up to date (current) and stipulate the required frequency (e.g., semi- annual, etc.) of these reviews.

E. If an external personnel agency is used are the recruitment methods utilized by said external personnel agency known?

2. Employee training. Does the plan identify/include/address the following?

A. If members of the Food Defense Team are trained, prior to their assignment, in the provisions of the plan and identify other food defense training received.

B. If ALL (new/current) employees are trained in the defense policies and procedures of the company. Does the training include instructions for employees to immediately report suspicious activity, external/internal threats, or if they suspect wrong doing or product tampering by other employees to their supervisor or other management personnel?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

3. Control of employees. Does the plan identify/include/address the following?

A. Identify the procedure/method used (e.g., photo IDs with expiration dates, company badges, etc.) for controlling entry of employees into the plant during both working and non-working hours. Are these verified upon entrance at the facility?

B. Indicate if an updated list is maintained for plant personnel with open or restricted access to the establishment.

C. Identify the procedure/method used (e.g., color-coded uniforms or coded badges) to make it obvious when employees move to areas of the facility other than where they normally work.

D. Are only designated employees allowed in sensitive areas or areas where the product is open to contamination?

E. Is there a written procedure listing and enforcing a policy on what personal items are not allowed inside the plant?

F. Does each department keep a roster of employees working on any given day? Is the roster updated daily? Is the roster distributed to all plant supervisors?

G. Upon the termination of an employee, is there a procedure in place to immediately restrict access to the facility by this individual? How?

B. Visitors/Guests/Contractors: Does the plan identify/include/address the following?

1. If the visitor policy requirement and method used to control entry into the facility requires positive identification for ALL visitors (e.g., picture IDs, sign-in and sign-out at the gate, reception desk, etc.).

2. Procedure for examining/inspecting briefcases, backpacks, toolboxes and/ or other containers prior to entering the facility.

3. Procedure to control visitors (contractors, salespeople, truck drivers, etc.) movement to prevent them from accessing restricted areas such as production. Are visitors escorted/accompanied at ALL times by an authorized plant representative while in the facility?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013- N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

4. Procedure to control visitors (contractors, salespeople, truck drivers, etc.) movement controls in place for contract workers (e.g., sanitation crews, pest control, etc.,) to prevent intentional contamination of product?

A. Is access to the facility limited to only those areas of the plant relevant to their work? Are contract workers escorted by an authorized plant representative while performing work in the facility or when they must work in sensitive areas?

B. Is there a written procedure listing and enforcing a policy on what personal items may and may not be allowed inside the plant and within production areas?

IV. SECURITY OF PERIMETER, BUILDINGS, DOCKS, AND RECEIVING/ SHIPPING AREAS:

A. Perimeter. Does the plan identify/include/address the following:

1. Is the plant perimeter monitored for signs of suspicious activity or unauthorized entry? How? Identify the measures in place (e.g., fencing or other barriers, “No Trespassing” signs, etc.) to prevent unauthorized access within the boundaries of the facility/buildings.

2. Identify the measures in place to protect the facility/buildings from unauthorized entry during operation and non-operational hours. Identify if access points into the facility are controlled using a combination of the following: Fences, security guards, alarms, locking devices, lighting, surveillance cameras, emergency exits alarmed have self-locking doors that can be opened only from the inside, or other defense hardware consistent with national and local fire and safety codes.

3. Is a procedure available identifying areas of concern and programs in place to monitor unauthorized access and prevent defense breaches of the following: Control panels, vents for air circulation lines, pipes, electrical lines/boxes, gas or pressure valves, doors, windows, roof openings, vent openings, trailer bodies, railcars, etc.

4. Are outside storage tanks containing hazardous materials, potable water, and bulk storage tanks secured (e.g., locks, seals, sensors) at all times?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

5. Is access to central controls for airflow, water systems, electricity and gas restricted and controlled? Do your airflow systems include a provision for immediate isolation of contaminated areas or rooms?

6. Identify procedures in place for inspecting trucks entering the facility boundaries. Are incoming and outgoing vehicles/trucks (both private and commercial) inspected for unusual cargo or activity?

7. Are truck drivers required to possess and present upon request adequate identification prior to entering the facility/gate?

8. Are deliveries verified against a roster of scheduled deliveries? Are unscheduled deliveries held outside the plant premises, if possible, pending verification of shipper and cargo?

9. Is there a waiting room for drivers? Is access from the waiting room to other parts of the facility controlled? If so, how?

10. Do you have parking areas for visitors situated at a safe distance from the main facility? Is the area segregated from production areas, storage, utilities, fuel tanks, etc. by adequate defense fencing or otherwise? Is this area monitored?

11. Are vehicles of authorized visitors, guests, and employees clearly identifiable (placards, decals, etc.)?

12. Have the normal routes for personnel entry to/exit from your facility been assessed? Are all points monitored or controlled?

13. Are your emergency alert systems fully operational and tested and locations of controls clearly marked?

B. Incoming/outgoing shipments: Does the plan identify/include/address the following as applicable?

1. Review and Maintenance of Records. Are records reviewed and maintained for all delivery conveyances (e.g., tankers, railcars, ships, etc.) used to transport food products?

2. Is there a policy for deliveries during non-operational hours to ensure prior notice of such deliveries and to require the presence of an authorized individual to verify and receive the shipment?

3. Is there an advance notification (by phone, e-mail, fax, etc.) required for all incoming/outgoing deliveries, including pertinent details about the shipment and the name of the driver?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

4. Defense seals (incoming): Is there a requirement for incoming shipments to be sealed with tamper-proof, numbered seals and that seal numbers be recorded on the Shipping documents/Bill of Lading? Are seal numbers verified prior to entry of the facility and registered/logged in per incoming shipment? Are seal numbers inspected for possible tampering for incoming shipment?

5. Defense seals (Outgoing): Is there a requirement for outgoing shipments to be sealed with tamper-proof, numbered seals or padlocks with individual identification numbers, and that seal number/ padlock identification recorded on the Shipping documents/Bill of Lading?

6. Are shipping documents with suspicious alterations thoroughly investigated and is there guidance for this type of incident?

7. Are loading docks secured to avoid unverified or unauthorized deliveries? Are there procedures in place for handling deliveries to this area?

8. Does the plan indicate how they ensure open trucks are not left unattended during off- loading and loading and sealed immediately after loading?

9. Is there a capability for verification of driver location and load at any time?

10. Have defense procedures been developed and implemented for drivers when docking or stopping for meals, gas, breakdowns, etc.? Is there a requirement that drivers keep trailers locked down at all times?

11. Are there predetermined protocols for drivers when faced with suspicious circumstances? Are drivers required to immediately report suspicious activity and any instances of suspected adulteration or tampering with the shipment? Are drivers provided a list of telephone numbers of officials to contact during operational and non-operational hours?

C. Mail Handling: Do you have a separate mail handling facility or room away from in plant food production/processing operations? Are your mail handlers trained to recognize and handle suspicious pieces of mail using U.S. Post Office guidelines?

D. Water/ice: (Applicable to all Subsistence Contractors to include food processors)

1. Water Source: Does the plan identify all sources of water used in the facility (both potable and non-potable sources) and are defense measures associated with each source of water?

2. If a municipal water supply is used, is there a procedure to immediately notify local municipal/health officials in the event of any abnormalities or if the water supply in the facility is compromised?

3. Water Testing: If municipal water is used, has the supply system procedure been reviewed and samples taken at several locations within the plant? Identify frequency of water testing to verify microbiological and chemical safety? Does the testing also include testing potable water with respect to federal/state/local water quality standards? Is the defense of well systems reviewed at least monthly and samples taken at several locations within the plant for microbiological checks?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

4. Do you inspect the potable and non-potable water lines in food processing areas periodically for possible tampering as applicable to the facility? Identify the frequency.

5. Is your in-plant ice-making equipment and ice storage facilities monitored and have controlled access?

V. RECEIPT INSPECTION: Does the plan identify/include/address the following:

A. Identify the procedure for inspecting for evidence of intentional tampering? Are tamper evident packaging features used when available for certain ingredients and supplies?

B. Are receipt inspectors trained to look for obvious signs of shipment and/or product tampering and to verify the integrity of incoming shipments and products during their receipt inspection?

C. Are all deliveries checked against orders made and is packaging/packing integrity inspected at the receiving dock for evidence of tampering prior to opening containers for signs of tampering or other anomalies?

D. Are “Accept” and “Reject” criteria for all incoming materials well understood by personnel signing for or receiving products, including courier packages of minor ingredients or laboratory materials?

E. Does incoming materials have clear, legible lot codes for traceability? Are all lot codes for incoming ingredients, processing aids and packaging materials identified on production records to ensure that products are traceable from receipt, production to finished products?

VI. WAREHOUSING AND STORAGE: Does the plan identify/include/address the following:

A. Warehousing/Storage:

1. The person in charge of warehousing/storage, receiving, and authorizing the release of finished goods for shipment and ingredients/materials for use in production, clearly identified (by positions)?

2. The procedure for storing product adequate to control access and minimize or eliminate the possibility of product adulteration/tampering? NOTE: The plan must identify all internal/external/contracted storage facilities used to store ingredients/ products/materials intended for DLA Troop Support customers.

3. Do you have an emergency plan that identifies all areas in which products and ingredients are handled and stored (e.g., off-site warehouses, product chillers, and storage facilities)?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

4. Are restricted areas inside the plant clearly marked, secured, and the manner in which access is controlled clearly stated?

5. Do you have updated plant layout schematics available at strategic and secured locations in the plant?

6. Are there procedures for handling damaged and/or returned products and are these inspected for evidence of possible tampering before salvage or use in rework? Are records kept if these products are used?

7. Is an inventory kept of product in the warehouse (including location)? Are you maintaining an accurate inventory of finished products to allow detection of unexplained additions to or withdrawals from existing stock?

8. Are stored product/ingredients segregated by manufacturer and lot number to expedite isolation, inspection, or recall capability?

9. Are labels held in a secure area to prevent label theft and misuse? Is there a plan in place to identify and contain mislabeled products?

10. Do you have accountability programs, such as “sign-off sheets” for all restricted ingredients? Is there a list of personnel authorized to handle highly restricted ingredients?

11. Is controlled access maintained for all product and ingredient storage areas? Is an access log maintained?

B. Control of hazardous material:

1. Are procedures and physical barriers (e.g., locks, keyed access by authorized personnel only) in place to restrict access to hazardous compounds such as nitrite, cleaning and sanitizing chemicals, pesticides, etc? Are these materials properly labeled?

2. Is a daily inventory and material usage log maintained of hazardous chemicals or other products and are all discrepancies investigated immediately? Are Safety Data Sheets (SDS) up to date, readily available, and accessible in case of emergency?

3. Is there a procedure to ensure cleaning and sanitizing chemicals, lubricants, paints, pesticides and other non-food chemicals are stored away from food processing areas, under controlled access and with documented inventory?

4. Are comprehensive and validated defense and disposal procedures in place, particularly for the control of agents, hazardous materials and live cultures of pathogenic bacteria?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

VII. PRODUCTION AREAS: Does the plan identify/include/address the following?

A. Control of personal items and equipment issue:

1. Is there a procedure listing and enforcing a policy on what personal items are not allowed inside the production areas?

2. Are utensils such as hand- held dial thermometers, knives, and/or other potentially dangerous equipment/utensils distributed and accounted for on a daily basis?

B. Ingredient Safety:

1. Are procedures in place to monitor the operation of pieces of equipment (blenders, choppers, poultry chill tanks, etc.) to prevent product tampering?

2. Does the plan indicate if projected and actual use of restricted ingredients is verified at the end of each day, by someone other than the employee who logs the ingredient?

3. Does the plan indicate if the integrity of packaging materials of all spices and restricted ingredients (including premixes prepared in the plant) are verified prior to use?

C. Batching/Mixing:

1. Is access to product production or holding areas restricted to plant employees and authorized inspection personnel only?

2. What types of controls are in place during mixing/batching of product or ingredients to prevent employee tampering, especially in areas where employees are by themselves without supervision or a coworker present??

3. Have points where clandestine access to product is possible been identified? Are these points monitored? How?

4. Are areas in which large amounts of product are exposed, (e.g., vats, kettles, tanks, chillers, cooler, etc.) restricted?

5. Is traceability for all ingredient components, oxygen scavengers, packaging materials (that come in direct contact with food), etc, used in the production of finished products recorded and maintained in case of a recall?

6. Are there specific procedures that define how product is to be reworked during processing? Are products to be reworked and related records/documentation properly identified and handled securely?

7. Does the plan identify procedures to follow in the event an intentional contamination occurs during the production process?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

8. Are protocols in place for segregating unprocessed products from processed products? Is there a plan that addresses the deliberate mixing of processed and unprocessed product (e.g., retort by pass)?

9. Are processing systems, including automatic control systems, secure? Are individuals with access to control systems identified?

D. Laboratory Control:

1. Is access to in-plant laboratory facilities strictly controlled?

2. Are all positive pathogen culture controls kept locked?

3. Are mercury thermometers accounted for on a daily basis?

4. Do you ensure only sample collection laboratory materials are permitted on the manufacturing floor?

5. Do you maintain an up-to-date inventory of all hazardous laboratory chemicals and solvents and are these materials securely locked?

VIII. EMERGENCY PROCEDURES: Does the plan identify/include/address the following?

A. Coordination with DLA Troop Support, Local, State, or Federal Authorities. If a breach of security or suspicious activity does occur, timely notification and cooperation with local/state/federal authorities and public health and/other local officials as appropriate is crucial. In addition to alerting the aforementioned officials, DLA Troop Support requires that, in addition to other reporting, product contamination/adulteration or that presents any other health or safety hazard to DLA Troop Support customers whether accidental or intentional be immediately reported to the applicable Contracting Officer so that immediate action be taken by DLA Troop Support under the DoD Hazardous Food and Nonprescription Drug Recall Reporting Program.

1. Does the plan identify a specific procedure for the immediate notification of the aforementioned officials and for handling and investigating food defense situations such as internal/external threats, suspicious activity, actual or potential cases of tampering or other malicious, criminal, or terrorist actions against any facility producing/assembling/storing, product or shipments intended for DLA Troop Support Customers?

2. Does your plan have a current list of local, State and Federal Government Homeland Defense contacts, public health officials and applicable DLA Troop Support personnel? How often is this list updated? Is this list distributed to company's personnel and copies maintained at the facility and of site?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

3. Have procedures been established with community emergency personnel to assure proper access to the facility during an emergency while still preventing public access? Are specially designated entry points for emergency personnel identified in the plan?

4. Are there provisions in the plan to deal with onlookers or media representatives that may be present during an emergency situation?

5. Does the plan include an evacuation plan for each facility if necessary (bomb threat, fire, flood, chemical spill, etc.) and include provisions to prevent product tampering during the evacuation process?

6. Food Defense exercise/drills: Are these conducted to verify key provisions of the plan? At what frequency? Are results reviewed and changes made to the plan if deemed necessary?

7. Are employees trained and instructed to immediately report any sign of possible product tampering or break in the food defense system? Note: It is imperative that all employees are reminded that timely notification is essential to any perceived or potential threat.

B. Communication: Does the plan identify and/or address the following:

1. A policy to ensure employees and truck drivers are frequently reminded to keep a low profile and not share information regarding products intended for the military/DLA Troop Support customers: Quantities, criticality of products being produced or shipped to the military, customer routes, and/or discussed other information concerning the facility or shipments.

2. Are truck drivers provided/have communication devices and emergency telephone numbers in the event of an emergency during operation/nonoperation hours?

C. Recall strategy:

1. Does the plan identify the person responsible (appropriate backups) for investigating and proper handling and disposition of recalled product, identifying customer contacts, addresses and phone numbers?

2. Is there a program in place to ensure the timely identification and segregation of all products involved in the event of deliberate product contamination? Does this program identify the corrective action plan for product tampering to ensure adulterated and/or potentially injurious products do not enter commerce and the immediate recall of adulterated products from trade and consumer channel?

3. Does the plan identify a procedure for the safe handling and disposal of products contaminated with chemical or biological agents?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

4. Do you have a relationship established with appropriate analytical laboratories (Government and/or private) for possible assistance in the investigation of product-tampering cases?

5. Product Mock recalls: Are these conducted to verify key provisions of the plan, if so at what frequency? Note: The DLA Troop Support Quality Audits & Food Defense Branch (FTSB) conduct unannounced product mock recalls periodically of actual products delivered to DLA Troop Support customers and/or ingredients/materials used in the production and packaging of food products. Operational rations contractors, Prime Vendors, and other subsistence contractors must be able to account for raw ingredients used in the production of food products, oxygen scavengers, and packaging (material that come in direct contact with food) and/or products shipped to DLA Troop Support customers within 24-hours of first contact. During DLA Troop Support Mock recalls contractors must able to identify quantity received/used/in-storage at their facility and quantity shipped to each DLA Troop Support customer, etc.

6. Are you performing a defense inspection of all storage facilities (including temporary storage vehicles) regularly, and logging the results? If so at what frequency?

7. Does the plan identify a procedure to ensure the trace-back and trace-forward of all raw materials and finished products?

IX. SUBCONTRACTORS/SUPPLIERS: Does the plan identify/include/address the following:

A. If the contractor verifies suppliers/subcontractors' compliance with FDA's establishment registration requirement as per the CFR? Is a current list of suppliers, establishment numbers, items produced, and date of registration maintained for each supplier?

B. If the contractor is purchasing from a list of certified, qualified or approved suppliers, contracted suppliers and/or if they also buy products from the open market?

C. If consideration is given to assure the integrity of food defense measures in the selection of all suppliers (meat, non-meat ingredients, compressed gas, packaging materials and labels, etc.)? Does the plan indicate if new suppliers are investigated for their food defense programs and are the programs of existing suppliers known and acceptable?

D. The type and extent of control exercised by the contractor over their suppliers regarding food defense and measures that should be taken to protect the ingredients/materials used in the production of finished products, finished products, and shipments intended for DLA Troop Support customers?

DLA Troop Support FOOD DEFENSE CHECKLIST

REFERENCE: Operational Rations Contract/TDP Section E; USDA-FSIS Model Food Security Plans; USDA-FSIS Industry Self- Assessment Checklist for Food Security; FSIS Directive 5420.1, Revision 1 (Food Security Verification Procedures); FDA Guidance for Industry, Food Producers, Processors, and Transporters - Food Security Preventive Measures Guidance, FDA final rule FDA-2013-N-125-0146 of FSMA, and 2006 Joint Government Operational Rations Food Defense Vulnerability Assessment Summary.

CAUTION NOTES:

1/ DLA Troop Support: The Quality Audits Food Defense Branch (FTSB) is the only DLA/DLA Troop Support office authorized to receive, review and approve Food Defense/Force Protection plans. ALL Food Defense/Force Protection plans and QSPs are maintained and secured by FTSB. All FTSB's auditors reviewing Food Defense Plans possess and maintain, as a minimum, a Secret Clearance prior to re viewing said plans.

2/ Government Quality Assurance Representatives (GQARs) :

A. GQARs (military and civilian) performing Government Source inspection at Operational Rations facilities shall NOT be provided a copy of the Food Defense Plan nor be allowed to remove copies of the plan from the area where the plan is secured at the contractor's facility.

B. Prior to the contractor authorizing the review of the plan by the supervisory GQAR assigned to the facility, the GQAR must sign a confidentiality/ nondisclosure agreement and only be allowed to review the plan in a private area under the oversight of a member of the Company's Food Defense Team.

C. GQARs are required to call FTSB if they have questions/concerns regarding the contractor's food defense plan.

3/Securing the Food Defense Plan:

A. If a contractor (operational rations) is producing under the Higher-Level Contract Quality requirements (require a QSP), remove the Food Defense Plan from the QSP when the QSP is submitted to the Government Inspection offices/GQAR.

B. Copies of the Food Defense/Force Protection Plan shall not be provided or mailed to Government visitors or to other unauthorized personnel. Discussing specific details or allowing unauthorized personnel (contractor/Government/other) to review the Food Defense Plan may compromise the integrity of the plan and/or the security of the facility and the products produced.

C. Contractors shall immediately contact the applicable DLA Troop Support Contracting Officer and FTSB if a copy of the plan is requested by unauthorized personnel or for questions/concerns regarding DLA Troop Support contract requirements for food defense/force protection.

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